To: Hob Wevant, RBP 
Captain, LISPHS that.)
Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

I  -. . .  ..   

 

 

Subiect: Februarl,I 15, 2012 incident in Building . 33

Date: June 20, 2012

 

furposepf Beppft .. .-  Field Code Changed

The purpose of this report is to describe the investi ation ofa potential expoSure to a select agent caused unsafe operating conditions In an animal biosafetv 42 ?lmm- Iocated In 

 

LJ-on the Center for Disease Control and Prevention?s Rovbal campus in Atlanta, Georgia. The facility

252mb}

Accession Number:

areas covered by this report are registered with the Division of Select Agents and Toxins and
approved for work with Biological Select Agents and Toxins This investigation report. prepared by the
CDCIDSAT biosafetv team is a compilation of interviews, documents and observations made during a site visit
conducted between Mav 1-3, 2012. As such, information presented in this report has been either taken
verbatim from some of the documents supplied to the team, paraphrased based on the best interpretation that
could be made from these documents, and on-site observations and interviews

Background

On Februarv 16, 2012, a group ofgovernment empiovees participating in the Federal Select Agent Program?s
Interagencv Inspector Training Program toured theatrlitv located in Building on CD05 Rovbal
Campus in Atlanta, Georgia, This program was established to support coordination of training tasks prescribed
in Executive Order 13545.

During the tour, the trainee escort, a DSAT member, observed that a "verv noticeable puff of air could be felt
coming through the slit in the window out into the 'clean? corridor.? This incident occurred while the trainees
were in the corridor libiI-iBl-i42 viewing animal holding areas through the procedure room door of room
Two floor plans are provided below for reference. One floorplan illustrates the quadrant of the
ibii3izi42 where the incident occurred. The second floor plan shows an enlargement of the

use. a 2523i
lab area ir this quadrant.

 



 

 

vivarium i

use: 

 

 

 

The trainees were standing in the outer corridor near the door connecting the with the interior of the
laboratorv. Entrv into this I. on ?5:63:42 Ias can be Seen on the
floor plans between use. a esaaihi The Biosafetv and Microbiological and Biomedical Laboratories, 5lh ed.
a voluntar code of biosafetv practice jointlv published bv CDCand the National institutes of Health
{Nil-l] advises tha [Emu 252m?: Irequirement formaboratories.
See p, 82, BMBL (section However, rooms in this vivarium are 252mm linto

 

 

Special91714 Page: 2 Scan Datet 2014-09-17 COPY

the suite from the clean corridor. This door can be seen above the numeral 2 in the label on the floor plan.
This door is the location where the trainees were standing at the time of the incident. This door is equipped with
a window and an opening in the frame that allows air to flow into the inner area of the laboratory when the
ventilation system is operating properly. According to the Blv?lBL. proper design and operation of an ibii3ii4
laboratory should en5ure that ?the direction of airflow into the animal facility is inward; animal rooms maintain
inward directional airflow compared toadjolning hallways.? See p33, BMBL [section 

 

While viewing prairie dogs held within the innermost room, the door between the two rooms inside the
laboratory suite closed quickly, causing air to flow out through the slotted window and into the face of the
trainees. Late in the afternoon on February 16. 2012 CDC's Of?ce of Safety, Health, and Environment was
noti?ed by DSAT of the air flow incident. DSHE representatives responded the next morning to investigate.

 


 use. eaearh:
it 

ib;i3;:42 use. a 252mm

 

 

 

 

 

 

 

[b][33242 U.S.C. 2523M:

 

 

 

Accession Number: Specia191714 ge: 3 Scan Date: 2014-09-17 COPY

 

 

U30. 262mm

 

 

 

Accession Number: Special91714 Page: 4 Scan Date; 2014-09-17 COPY

Observationsf?ndings of the DSAT Investigation

1} The major concerns raised by any potential release of a BSAT are the risks for harm to public health and
the potential exposure of laboratory workers to biohazards. Based on a review ofthe information
collected during this investigation, there is no credible evidence that there was either an occupational
exposure or a release of any BSATs from the suite as a result of February 15, 2012 incident.

2} There is evidence that there was a malfunction in the processes that maintain the inward directional
airflow into the space at the time of the incident. It has been con?rmed by tests performed by DSAT
inspectors that the airflow control process appears to be functioning properly at this time.

3] There is some disagreement between the eyewitnesses of the event and the CDC safety staff with
regard to the magnitude of the air?ow reversal that was observed by the trainees. In written statements
from eyewitnesses, the air flow reversal was described as "a very noticeable puff of air" while the
reports from CDC safety staff describes the reversal as "a small puffofair?. While neither of these views
is quantitative, the contrast is noted. -

4} There are deviations from the BMBL guidance with respect to the design and operations ofthe
suites in the Building vivarlum. First, the BMBL states that, "Doors to areas where infectious materials
andfor animals are hosed, open inward, . . . See p82, BMEM [section 01}. As seen in the exit doors
in the diagrams provided with this document, doors opening into the central corridor open outward.
{See first ?gure above]. This departure from the BMBL guidance, while listed on the most recent annual
validation checklist Supplied to DSAT as an item to be examined for these rooms, is left blank on the
document. This document was dated January 9, 2012.

The second departure from the EMBL guidance is the requirement that 'Entry into the containment area
is via a entry, which constitutes an anteroomfairlock and a change room. Showers may be
considered based on risk assessment. An additionalaccess anteroom or ?1212321142 
autoclave may be provided for movement of supplies and wastes into and out ofthe facility.? See p32,
EM BM (section Di]. While there is a ?138314 anteroom provided for entry from the outer corridor,
there are also additional doors located into these labs from the outercorridor that permit entry directly
from-the corridor into the laboratory. Itwas one of these doors through which the transient air?ow
reversal occurred. These doors are used to move clean cages into the Suites during operations including
areas used for work with other agents U-S-C- land TB.

 

  

When CDC staff were asked about this procedure, DSAT inspectors were told that a risk assessment was
performed that allowed this work flow to be permitted. However, there was no written copy of this risk
assessment available. Some concern about this discrepancy between the EMBL guidance and this
activity, movement ofanimal cages into a 'hot' lab through a single door from the clean corridor,
was detected during interviews with workers.

5} There were also some indications that all workers did not clearly understand the basis for the

containment practices in use in the viva rium. For instance. one worker thought that the correct direction
ofairflow between the central corridor and the contaminated animal holding areas was opposite to the

Accession Number: Special91714 Page: 5 Scan Date: 2014-09?17 COPY

correct direction. Given the heavy reliance on visual indicators for detection of air?ow anomalies rather
than electronic sensors commonly used in other high containment facilities in the US to detect air?ow
reversals, this lack of understanding of correct airflow represents a potential safety risk.

6} The reliance on visual monitoring of airflow rather than use of sensor based technology raises several
other concerns. First, the mechanical problem that resulted in the ?very noticeable puff of air? observed

by the trainee May have previouslv escaped detection. While it is possible that the defect may have   ..  .. .. ..  . 

originated on the dav of the training session, this scenario is extremer optimistic. More importantly,
this raises the questions of how long had this condition existed and how long would this problem have
continued to exist before detection. Fortunatelv, the laboratorv did not contain infected animais at the

time of the incident.

There was ventr meager data available to review regarding the annual facility safetv veri?cation process.
Records supplied to DSAT to document annual safetv veri?cation activities of vivarium 
performance are included in Appendix 1. For comparison, electronic pressure differential data provided
bv another entitv during a recent investigation by DSAT is also shown in Appendix 2. This electronic
sensor data allows tracking of differential pressures between zones in a U-S-C- 262%: DSAT was
told by CDC. staff that no such information is collected or available for our review because it is not a
specific requirement addressed in the BMBL However, such data tracking does allow retrospective
analvsis of airflows and could have possiva identified the anomalv associated with the airflow
disturbance without relving upon a visual indication of the problem.

 

We were treated with respect and received professional cooperation bv the CDC RD and others involved-
with this effort.

3



5n mmarv

DSAT conducted a review of circumstances surrounding a report of an incident that mav have resulted in a
potential release of BSAT in anlaboratorv in Buildinat the CDC Hovbal campus. Based on the report
of a transient air?ow reversal from the Iaboratorv through a corridor door, concerns were raised about the
possibilit~..I of an exposure of visitors in the area to infectious agents.

After reviewing documentation related to the status of the laboratory, interviewing staff members and
conducting tests of the ventilation system performance, there does not appear to be anv reasonable basis to
conclude that there was a signi?cant exposure to infectious agents or any release of outside of the
secondanlr containment barriers of the facilitv. in addition, the mechanical problem that caused the transient
airflow reversal has been corrected and veri?ed to function properiv.

2914-09?17 cosy

6 Scan Date

0


Page

Specia191714

Accession NUmber

APPENDICIES

Appendix 1 Data supplied by CDC during inspection upon request by DSAT

VNaHumDec 11 - 


   

Appendix I. Data supplied by a university laboratory during Inspection upon request by DSAT

 

Reference
Decume nt. 

Accession Number: Specia191714 Page: 7 Scan Date: 2014-09-17 COPY

 :eaea ueos 3 :3525 uotssaoov

To: Rob Weyant. 
From

Subiect: Investigation ofa potential exposure to a Biological Select Agents and Toxin in a CDC Ftoybal
biocontainment facility.

Date: May 24, 2012

 

Parse-ereField Code Changed

 

The purpose of this report is to describe the investigation of an allegation of unsafe operating conditions in an
animal libi?s'ii? 252th Ila boratory approved for work with BSAT located at the CD
campus in Atlanta Georia. According to this allegation, a brielI reversal of air?ow from the interior of th
laboratory, designated occurred during a training session for Department of Defense inspectors on
February 15, 2012. This investigation was conducted by the Biosafety team after notification of the
allegation on April 9, 2012. This report is a compilation of interviews, documents and observations made by the
DSAT Biosafety team members. As Such, information presented in this report has been taken verbatim from
Some of the documents supplied to the team or paraphrased based on the best interpretation that could be
made from these documents and on-site observations. Interviews staff and contractors} were
conducted with the assurance that comments would remain non-attributable.

    

Background

Executive order 13545 entitled ?Optimizing the Security of Biological Select Agents and Tor-tins?, issued on July
2, 2010, in part, requires that "the policies and practices used to secure BSAT are harmonized and that the
related oversight activities of the Federal Government are coordinated." {see section 6a, "Coordination of
Federoi Dversightfor BSATSe-curity?i. The Division of Select Agents and Toxins was tasked with
designing, developing and implementing a training program that would ensure harmonized practices among
federal partners participating in inspections of entities in the US that possess ESATs.

In order to ful?ll this assignment, DSAT has developed the Interagency Inspector Training Program. The goal
of this program is to provide the knowledge, skills and experience to inspectors from Federal partners that
conduct "internal" inspections of registered entities that operate or are funded by their organizations. In
addition, this training will enable inspectors from these agencies to participate in joint inSpections with CDC and
APHIS. The IIT program consists of lectures and tours of several sites of biosafety facilities at the CDC Roybal
campus.

Chronology of Events and Communications

October 14, 2011 First IIT Program training session conducted 

Conference call was held with DSAT Director, NCEZID and DIDIDD senior
entry requirements for training classes.

February 2, 2012

 

managers to clarify - Ii" 
Second Program training session conducted at CDC.
Class consisted of 2 new DSAT inspectors and 2 inspectors from the Department

of Agriculture?s Animal and Plant Health InspECtion Service
Februarv 16. 2012 Third IIT Program training session conducted at CDC.

Class consisted of 4 inspectors from the Department of Defense

During the Februarv 16 tour ofthefacili an air?ow reversal incidentoccurred while the tour members
were in the "clean" corridor, viewing areas through the procedure room door of
[me-?2 ?5-05 Two floor plans including one that illustrates the quadrant of th vivariurn in Building here
the incident occurred and a second floor plan showing an enlargement of thelab area in this quadrant are

  
 

 

shown below for reference.

The trainees were standing in the outer corridor near the door connecting the with the interior of the

Entrv into this laboratorv usually requires passage through a central ante room seen on the floor

lans between [b10342 U-S-C- 2523 Passage through two self?closing doors is a basic design requirement for
015" laboratories [see BMBL p.82 . section D1, paragraph However rooms in this vivarium are also equipped

  

eaearh:  
with a single door entry into the suite from the clean corridor. This door can be seen above the numeral 2 in the
gag-Egg? label on the floor plan. This door is the location where the trainees were standing at the time of the

incident. This door is equipped with a window and an opening in the frame that allows air to flow into the inner
area ofthe laboratorv when the ventilation system is operating properly. According to the BMBL, edition,
proper design and operation of alaboratorv should ensure that "The direction of airflow into the
facilitv is inward; - ii

section 

 

Accession Number:

Specia191714

Page: 9

Scan Date:

2014-09-17

COPY

 

U30. 2525mm;

  [331133142 U30 

io;r3::42 U30. 2'52aihj;

 

 

 

 

 

USE. 252mm

 

 

 

 

innermost room, the door between the tw rooms inside the
causing air to flow out throu the slotted window and

I

While viewing prairie dogs held within the
laboratory suite closed with greater force than required,
into the face of the trainees.

 

 

ibj:i3;::42 use. 252m;

 

 

 

Accession Number: Specia191714 Page: 10 Scan Date: 2014-09?17 COPY

Late in the afternoon on February 16, 2011 DSHE was noti?ed lav DSAT of the air flow incident.

representatives responded the next morning to investigate.




 

 

CDC DSHE acknowledges noti?cation lav DSAT {Appendix 2}




 

April 09, 2012



Aprn09,2012

April 25, EUR

ARE management approves training session (Appendix 6)
BEAT [and Dr Frieden] receives first notice of safety complaint by ARE staff
{Appendix 

Meeting Roster

 

 

use. eaeathjz-tbxaj:

 

 

Powell, Nathaniel 
Black. Carolyn (cocfolomcezmi
Bowen, Ken L. 

Probst, Paul E. 

Accession Number:



Specia191714 Page: 11

Scan-Date:

2014-09-17 COPY

 

U.S.C. 
2528th)

 

 



 

April 26, 2012 Meeting follow?up. Interview requests, site visit logistics and plans arranged
- (Appendix 12}

April 30, 2012 interviewsiconducted traits: lfhiGHE U'S'C'?zr?a Ilr-?ippendiir 13}

 

Observations] ?ndings of the DSAT Investigation

1} The major concerns raised bv anvr potential safetv complaint or potential release involving a BEAT are
the potential for harm to public health and the potential exposure of iaizroratonlr workers to biohazards.
Based on a review of the information collected during this investigation, there was no credible evidence
that there was anv occupational exposure or release of anv BSATs from the suite during the
incident that occurred on Februarv 16, 2012.

2) There is evidence that there was a malfunction in the processes that maintain the inward directional
airflow into the space at the time of the incident. It has been con?rmed in tests performed bv DSAT
inspectors that the airflow control process appears to be functioning properly at this time.

There is some disagreement between the evewitnesses of the event and CDC safetv staff with regard to
the magnitude of the airflow reversal that was observed bv the trainees. In reports from these
evewitnesses, the air flow reversal was described as ?a very noticeable puff of air? while the reports from
CDC safetv staff describes the reversal as 'a small ?puff? of air?. While neither of these views Is I
ouantitative, the contrast should be noted.

4) There are deviations - I - authored guidance found in the EilviBL with respect to the design
and operations of thuites in the Specificallv. the BMBL states that, "Doors
to areas where infectious materials andfor animals are housed, open inward?. As seen in the exit doors
in the diagrams provided with this document. doors opening into the central corridor open outward.

 

{see ?rst ?gure above]. This condition. while listed on the animal validation checklistl?'is an_it_ern_tg_be -  ?ll-53
examined for these rooms, is left blank on the document.

 

 

 

The second deviation from the BMBL guidance is the requirement that 'Entrv into the containment area
. which constitutes an anti riomiairiock and a change room. Showers mav be
considered based on risk assessment. An additional ccess anteroom or [bil33142 

autoclave mav he provided for movement of supplies and wastes into and out of the facilitvf

 

 

While there is a 9333342 U-S-C- anteroom provided for entry from the outer corridor, there are also
additional doors located into these labs from the outer corridor that permit entrv directly from the
corridor into the laboratorv. It was one of these doors through which the transient airflow reversal
occurred. These doors are used to move clean cages into the suites during operations including areas
used for work with other agents U-S-C- 232%? land TB.

 

Accession Number: Specia191714 Page: 12 Scan Date: 2014?09?17 COPY

When asked about this procedure, DSAT inspectors were told that a risk assessment was performed that
allowed this work flow to be permitted. However, there was no written copy of this risk assessment
available. Some concern about the discrepancy between the BMBL guidance and this activity was
detected during interviews with ivorkersfl .- 

 

ibil?l

5} There were also some indications that all workers did not clearly understand the basis for the
containment practices in use in the vivarium. For instance, one worker thought that the correct direction  .. ..
of airflow be tween the central corridor and the contaminated animal holding areas was opposite to the
correct direction. Given the heavy reliance on viSual indicators for detection of airflow anomalies rather
than electronic sensors commonly used in other high containment facilities in the US to detect airflow
reversals. this lack of understanding of correct air?ow represents a potential safety risk.

 

 

 

 

 

The reliance on visual monitoring of airflow rather than use of sensor based technology, raises several
other concerns. First, the mechanical problem that resulted in the 'very noticeable puff of air? observed
by the trainee had previously escaped detection. While it is possible that the defect may have
originated on the day of the incident, this scenario is extremely optimistic. More importantly, this raises
the questions of how long had this condition existed and how long would this problem have continued
to exist before detection. Fortunately, the laboratory kvas not operationailat the time of the incident and --  (?3?53 

 

ironically, the observation made by the trainee has allowed the problem to be identi?ed and corrected
before the lab began to work with infectious agents again.

 

 

 

There was very meager data available to review regarding the annual facility safety veri?cation process.
After examination by the DSAT facility reviewer, the data provided to DSAT does not meet our current
expectations for other facilities ofthis type. I have attached a copy ofthe results ofthese veri?cation
documents given to us below.

As you requested, have provided another reference document that is an Example of the type of data
available upon request from many other entities. This electronic sensor data allows tracking of
differential pressures between zones in a suite. DSAT was told that no Such information
is collected or available for our review because it is not a speci?c requirement addressed in the EMBL.
Such data tracking however, allows retrospective analysis of air?ows and could have possibly identified
the anomaly associated with the airflow disturbance without relying upon a visual indication of the
problem.

 

Z'E-np I
 a.

VNartJm Dec 11 mi. REference

Copy. cor DOCUn'ent. 

3] During the meeting held on April 25 2012, several Individualsnoted that they
were not informed about the training activities associated with the incident and expressed concern

about their lack of awarenes about this activity. However, senior CDC personnel were noti?ed and
agreed to these activities in advance [see chronology above) DSAT regrets that this arrangement was
not communicated effectively.

Accession Number: Special91714 Page: 13 Sean Date: 2014-09?17 COPY

 

 

DSAT to the BSAT sub IPC. Finding a facilitv outside of
CDC to provide a similar training will entail additional costs to BEAT.

 

 

10] We were treated with respect and received professional cooperation by the CDC R0 and others involved
with this effort.

Summary

  

DSAT conducted a review of circumstances surrounding an allegation that anlaboratorv in Buildin
the CDC Rovbal campus was operating under conditions that were unsafe. Based on the report of a transient
air?ow reversal from the iaboratorv through a corridor door, concerns were raised about the possibilitv of an
Exposure to infectious agents.

I233: 311

After reviewing documentation related to the status of the Iaboratorv, interviewing staff members and
conducting tests of the ventilation system performance, there does not appear to be any reasonable basis to
conclude that there was a signi?cant exposure to infectious agents or am; release of BEATS outside of the
primar?ir containment barriers of the facility, In addition, the mechanical problem that caused the transient
air?ow reversal has been corrected and veri?ed to function properly.

Accession Number: Specia191714 Page: 14 Sean Date: 2014-09-17 COPY

APPENDICIES

Appendix 1

From: 
To: 
o: Powell, Nathaniel .nirai .icocioiomcezio]; 
Allison icocroiomcez
Subject: Airflow in 

 

        
   

lb:
[314

   

Good afternoot al

This morning I was a part of an escorted group that walked through of the clean areas in the lliuariurn of
and wanted to make you all aware of a circumstance that the group encountered. As the group
stood outside the door in the clean corridor, the ARES technician inside opened the door to 
the animal room. As the door closed a very noticeable puff of air could he felt coming through the slit in
the window out into the ?clean? corridor. I was told b? that this room does not house infected
animals at the present time] [bjzisi

 

 

Iibjf?';

 

 

 



 

Appendix 2

Finiceclocoorosnel

 

 

Cc: Powell, Nathaniel mil-6i: Williams.
Allison 

Subject: Re: Air?ow in 
Thankswe will look into it.




Appendil: 3

{Ella}
From 

To: ion-33:42 U30.?262arhjziejziaji 

 

Accession Number: Specia191714 Page: 15 Scan Date: 2014-09-17 COPY

"On behalf of the Associate Director for Science (ADS) at DSAT we want to thank you for your
participation and commitment to the Biological Select Agents and Toxins Interagency Inspector
Training {liTJ Program. The success of this training program is attributed to your insightful presentations,
enthusiastic discussions, and logistical support. Once again, we deeply appreciate all ofyou for taking
the time to participate in the program. We hope to count on your support in the future.?

 

raw-a:

 

      
 

   

seventies?) 

Appendix 5

(DRE:
From 

To: Powell, Nathaniel 
{cocxoeHPerosATil mils) toczolorucszro)

Subject: Request for DSAT Training

 

 

 

Following our conversation from this morning; ?rst I want to thank you for your support. We are trying
to schedule a trainin session for the last weel-r of April. 2012 for DSAT FTEs {5 participants}. i am waiting
:0 hear back from to decide on an era ct date. To answer your question: the
requirements to enter th last time were TB test and proof o'fprograml respiratory fit test. Again
thank you for your support.

 

 

Appendix 5

From: Powell, Nathaniel 


{cocroPi-Ieerosan;

 

Irb1i3j::42 use. 

      
 

cocmiomcszio)

 

 

 

 

 

 

Please coordinate your yisitwith 4"  . 252 
Thanks
Appendix 3'
mel 
Tor-W: ?cocroPHParosAn; Powell, Nathaniel {cocroiomceziol

Cc: Frieden, Thomas {Torn}  
Subject: RE: Request for DSAT Training

 

[bll?jelbjl?t

 

 

 

Accession Number: Specia191714 Page: 16 Sean Date: 2014?09?17 COPY

 

[bi-[332142 USC. 

 

 

 

 

 

?n




 

{Responsible Of?cial}

RE: Incidents During Tours of the Buildinivarium

 
 
 
  
   
  
 

14 2011 between 3 41:30 am, DSAT 

['3sz use. 252a and 
Ispace. Participants entered the containment area wearing PAPRs and showered out
en a 41:30 am escorted a second group to the

 
 
  

  
 
 

 

    

triuzarinrn?

 

 

. ., .
Il IThe second group was given the option oftouring the clean outside
of containment: they chose this option and did not wear PAPRs. According to ester 5 33 . as

the second group stood outside the door of room 31 31 in the clean corridor, the ARB technician
inside opened the door to the animal room. As this door closed, a tiersr noticeable puff of air could be
felt coming through the slit in the window out into the clean corridor.

 

  

ra  rie dogs were
lvirus. The BMBL states


An incident report was provided to BEAT from CDC. This report 
convalescing in the 3'3 room after an Experiment with infill-l?
that all persons working in or entering laboratori; or animal care areas where aetivities wit

   

 

  

Accession Number: Page: 17 Sean Date: 2014-09-17 COPY

virus a re being conducted should have evidence of satisfactorv vaccination. The two groups of visitors to
the vivarium included individuals who had not been vaccinated for .

 
 

In order to determine whether the visitors on February 14 and 15, 2012 were exposed to a select agent.
please provide the following information bv COB on April 20, 2012:

- Please submit a completed Form 3 along with an executive summarv [narrative] of events including
timeline ofwhat occurred.

a Please provide details on which rooms within the containment block were entered bv the ?rst group
of visitors.

0 Please provide information on the work activities being performed in all of the vivarium rooms
during the time intervals ofthe visit.

a What isfare the requiremehtls} for entrv into the containment block?

- Explain the procedure for preventing entrv ofunvaccinated individuals into areas where vaccination
is required. I

I Please con?rm the last time that active work was performed in procedure room   
tour by the second group.

6 Provide details on the animal housing used throughout the containment block and including any

animals housed at the time in animal holding room

0 Previous HVAC veri?cation test results provided to DSAT for the Building vivarium space were
qualitative and lacked room differential pressure trending data. Please provide pressure trending
data for each of the rooms in the vivarium containment block during the time of the second group?s
visit on February 16, 2012-

prior to the

 

 

Form 3 mailbox at: form3@gdc.gov

On all correspondences regarding this investigation, please be sure to include as

well.

Thank vou in adva nce for vour cooperation and coitaboration in this critical investigation.

 

Form 3 Site Visit Coordinator

Appendix?!
Good Afternoo . :2 

 

Per vour e-mail and attached letter ofepril 13, 2012I please ?nd attached the CDC response to vol
request for me to provide additional information regarding incidents that occurred in the Building  
Vivarium during tours on Februarv 14 and February 15, 2012.

 

 

 

CDC Response to
DEM Request 

Res ectfullv submitted,

 

Accession Number: Special91714 Page: Scan Date: 2014-09?17 COPY

 


Appendix 

CDC 021512 Form3
-Incidenl.pdf




Appendix 11

 

Fr 2' lcocroeHenyosAT}


{cocroeaenyosen 
Subject: Meeting forApril as, 2012

 

 
 

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff
on tomorrow at 1:30pm to discuss DSAT conce - ollowing our review of the information received April
20, 2012, related to the incident of the Buildinirvarium Tours. Again, my apology for the short
notice, and thank you in advance for your support and considerationlsl to DSAT's requests.

PS: I am notin the of?ce at this writing, this message is being sent via my BlackE-erry. Feel free to
respond at your earliest convenience. Most 

Respectfully,
ewe




Appendix 12

sralcocxoeneerosar}

Sent: Thursda A ril 26, 2012 [15de PM

To: .,

ocroPi-Ienrosan; [cocropnearosati

{coropnperose'r}
Subject: follow up to 4f25iv?2012 meeting

  
 
   

Based on our discussions yesterday, as part of our information collecting process, would like to request
your take: .ws with the following people:

1] 
2) Dr Nathaniel POWEII i:
3] 34 ARE workers that have duties in this area

the members of OSHE andfor who participated in the most recent HVAC functional testing of
this lab {limit to 3-4 staff-members from each). We do not need to intemiew supervisors at this time.

 

 

 

 

We would like to meet with these individuals separately next week. if possible, we would like to
schedule 15-20 minute interviews in the early afternoon [1-230 pm} any day next week. Of course, we

Accession Number: Page: 19 Sean Date: 2014-09-17. COPY

will try to accommodate any schedule conflicts. Depending upon the final number of individuals, we
anticipate being able to ?nish by Wednesday. But should the need arise, we can interview people later
in the week. Please send the names and proposed times that these people can be available.

In addition, I would appreciate it greatly if you could provide me with the following
informationfdommentation;

1} the date when this lab was last tested for proper airflow,

2) any documentation of this test,

3) the date when the lab was decontaminated prior to the reported air?ow deviation,

4] any documentation regarding the decontamination procedures and veri?cation of these processes.
5] specific entry requirements for the suites when the labs are hot and cold,

6) speci?c entry requirements for the clean corridor areas outside of the lab suites

My apologies if you have already provided any of this information in the documents currently under
review.

We would also like to conduct a series of relatively simple tests of airflow patterns on this lab and
several others in the same general area next week. We propose to stand outside of the containment
space in the clean corridor with smoke sticks and verify the direction of airflow while the inner door
inside the containment space is opened and closed in the same manner that caused the anomaly
observed by the visitors. We are not requesting any failure scenario testing. any HUAC system
manipulations or any other mechanical procedures to be performed during these tests. We will need
someone from either ARE or OSHE to simply open and close the inner door for various time intervals
while we observe the smoke patterns from outside of the lab area. These activities should provide useful
information about the Current status of the ventilation system function.

If possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

 



 

Division of Select Agents and Toxins

 

 

  

Appendix 13 I 
Good Afternoon 73.6.

Please see below for the interview schedule for this week's interviews.

Tuesday, May 1 Location: Building 24, Room 11-1D1A Time: 10:00 am.
individual: Dr. Nathaniel Powell

 

 

 

 

 

Tuesday, tv 24, Room Time: a.m.
individual:

Tuesday, was: 1_ lnratinn' Buildine 74, Room ll-l??lA Time: 11:00 am.
I _d 

nd'w U3 - [52.i'bzil3':

Tuesday, May 1Location: Bu lding 24, Room ll?l?l?t Time: 11:3(1 a.m.
individual: 

 

 

 

Accession Number: Specia191714 Page: 20 Sean Date: 2014?09?17 COPY

(ogre: I
currently on leave of absence through June 2012 and has specifically and personally

conveyed to her line management in 05R that she does not wish to discuss matters related to the
Building facility with anyone.

Wednesday, Ma 2 Location: Building 20, Room 2111 Time: 1:00 pm.

  
 

Individua

Wednesday, May2 Location: Building 20. Room 2111 Time: 1:30p.m_  .. .  mu?
Individual:  -

Thursday. May 3 Location: To Be Provided Time; gmlm?

Individual:

lit-aim? 3 Location: To Be Provided Time: 9:30 a.m.lndividual: Mr.
ions:

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members
of ARE, USHE, BFU and the Flo?s of?ce will be available to assist.

 

Other documentation that was requested in your e-mail of April 25 is forthcoming.

Sincerely,

 

{0133142 use. 5 252mm
Centers for Disease Control and Prevention
Select Agent Compliance, Ftoybal Campus

Accession Number: Specia191714 Page: 21 Scan Date: 2014?09?17 

To: Rob Wevant, 


Subject: Investigation ofa potential exposure to a Biological Select Agents and Toxin in a CDC Rovbal
biocontainment facility.-

Date: May 24, 2012

COPY

3014?09-17

 

Barrett .- I Field code Changed

The purpose of this report is to describe the investigation of an allegation of unsafe operating conditions in an
animal $513342 U-S-C- 2523i?? Ilaboratorv approved for work with BEAT located at the CDC Rovbal
campus in Atlanta Geor ia. According to this allegation, a brief reversal of air?ow from the interior of the
laboratory, designated mi: occurred during a training session for Department of Defense inspectors on
Februarv 16, 2012. This investigation was conducted bv the CDCIDSAT Biosafetv team after noti?cation of the
allegation on April 9, 2012. This report is a compilation of interviews, documents and observations made bv the
DSAT arosafetv team members. As such, information presented in this report has been taken verbatim from
some ofthe documents Supplied to the team or paraphrased based on the best interpretation that could be
made from these documents and on-site observations. Interviews of CDC staff and contractors] were
conducted with the asswance that comments would remain non-attributable.

 

 

Background

Executive order 13545 entitled "Optimizing the Security of Biological Select Agents and Toxins", issued on Julv
2, 2010, in part, requires that ?the policies and practices used to secure BSAT are harmonized and that the
related oversight activities of-the Federal Government are coordinated." {see section Ea, "Coordination of
Federo! Dversr?ghtfor BEAT Security?}_ The Division of Select Agents and Toxins was tasked with
designing, doveloping and implementing a training program that would ensure harmonized practices among
federal partners participating in inspections of entities in the US that possess BSATs.

In order to ful?ll this assignment, DSAT has developed the Interagencv Inspector Training Program. The goal
of this program is to provide the knowledge, skills and experience to inspectors from Federal partners that
conduct "internal" inspections of registered entities that operate or are funded by their organizations. In
addition, this training will enable inspectors from these agencies to participate in joint inspections with CDC and
APHIS. The IIT program consists of lectures and tours of several sites of biosafetv facilities at the CDC Rovbal
campus.

Chronology of Events and Communications

Dctober14,2011 First IIT Program training session conducted at CDC.

Class consisted of ?ve Department of Homeland Seturitv inspectors.

22 Sean Date

Page

Specia191714

Accession Number

February Conference call was held with DSAT Director. NCEZID and senior
managers to clarify entry requirements for training classes.

February 14, 2012 Second ilT Program training session conducted at CDC.
Class consisted of 2 new DSAT inspectors and 2 inspectors from the Department
of Agribulture?s Animal and Plant Health Inspection Service

February 16, 2012 Third Program training session conducted at CDC.
Class consisted of 4 inspectors from the Department of Defense

 

During this tour of thefacility, the tour members were in the "clean" corridor, yiewin

animal holding areas through the procedure room door of Room lbii'i33342

  


Two floor plans including one that illustrates the quadrant of the yiyarium in Buildin where the incident
occurred and a second floor plan showing an enlargement ofthe lab area in this quadrant are shown below
for reference.

The trainees were standing in the outer corridor near the door connecting thewith the interior of the
laboratory. Entry into this It Del use. 252mm Iseen on the floor
plans between rooms U-S-C- Passage through two self-closing doors is a basic design requirement for

 ib3 laboratories {see BMBL p.32 section D1, paragraph However rooms in this yiyarium are also equipped
with a into the suite. This door can be seen above the numeral 1 in the label on the floor
plan. This door is the location where the trainees were standing at the time of the incident. This door is
equipped with a window and an opening in the frame that allows air to flow into the inner area ofthe laboratory
when the ventilation System is operating properly. According to the BMBL, 5?h edition. proper design and
operation of alaboratory should ensure that "The direction of airflow into the animal facility is inward;
animal rooms maintain inward directional airflow compared to adjoining hallways.? (p32, section 

 

 

 

 

   

Accession Number: Specia191714 Page: 23 Scan Date: 2014-09?17 COPY

 

lib::l3}i42 U.S.C. 2623M:

 

Vivarium

 

 

 

l:bj:[33::42 use. 252mm

 

 

 

While viewing prairie dogs held within the innermost room, the door beMeen the two rooms inside the
laboratory suite closed with greater force than required, sending a small ?puff? of air out through the slotted
window and into the face of the trainees. This door location can be seen in the diagram ahoire the in the

wordon the enlarge ?oor plan.

 

$133242 U.S.C. 2?2aih}

 

 

 

Accession Number: Page: 24

Sean Date: 2014-09-17

COPY

February 16, 2012 04:13 PM

Februarv 16, 2?12 4:16 PM

Late in the a moon on February 16, 2011 OSHE was noti?ed bv DSAT ofa potential air flow incident in
the Building vivarium. DSHE representatives responded ?rst thing the next morning to investigate.

m,
DSAT notifies CDC DSHE about incident in

  

(cocroPHPe/osar]
To: 232a'l'h': 
Cc: Powell, Nathaniel 
Allison 

Subject: Air?ow in Bid

Williams,

 

Good afternoon 3 it

This morning I was a part of an escorted group that walked through of the clean areas in the vivarium of

wanted to make ou all aware of a circumstance that the group encountered. As the group
[tn-?3E? in the clean corridor, the ARB technician inside opened the door to

stood outside the door of' .
the animal room. As the door closed a verllr noticeable puff of air could be felt coming through the slit in
mm} that this room does not house infected

the window out into the "clean" corridor. was told bv
animals at the present time. However, there is a room with infected animals on this same corridor and if
this is happening in that room. does OHSIARB feel that there is anv risk of exposure to someone walking
down that hallwav without respiratory protection. Don't know if this was a fluke or the norm and the
reason I?m commenting is one of the visitors seemed concerned and has been talking aboutit since

  

we*ve come back.

CDC DSHE acknowledges notification bv DSAT

 

 

[Eli-242 USE. 

Cc: i-?owellI Nathaniel Williams,

Allison 
Subject: Re: Airflow in 

 

 

 

 

ib. . . .
[33:42 we Will look Into lt.

llr'n

Thanks

 

 

 

25 Sean Date: 2014-09-17 COPY




Page

Specia191714




 

iiebruarllr 23, Kill DSAT thanks CDC ARB for training class

 
  
 

Tl


 

. 

 

 

"On behalf of the Associate Director for Science at DSAT we want to thank iron for vour
participation and commitment to the Biological Select Agents and Toxins lnteragencv Inspector

Accession Number

Training {IlTl Program. The success of this training program is attributed to your insightful presentations,
enthusiastic discussions, and logistical support. lE?Jnce again, we deeply appreciate all of you for taking
the time to participate in the program. We hope to count on your support in the future."

February 23, 2012 ARE responds to DSAT

 


Frorn'll 'l lcocromfucezml



To ..
(haspleasure You have my complete support?
April [19. 2012 DSAT initiates request for another training session with ARB

From. 
To: Powell, Nathaniel 

cc: U.S.C. 252mm 
Subject: Request for DSAT Training

 

libli?l

I 

   
 

Following our conversation from this morning; ?rst I want to thank you for your support. We are trying
to schedule a training session for the last week of April, 2012 for DSAT FTEs {5 participants]. lam waiting
to hear back from Imus: ,4 lo decide on an exact date. To answer your question: the
requirements to enter the last time were TB test and proof of program! respiratory fit test. Again
thank you for your support.

 

April 09, 2012 ARE management approves training session

Froj .- .. nieiicocroipmcezio}
To: cocxoPHParosAT}

Cc: use. 5 252mm I I
icocroiorncsaoi, {cocroioruceaoi
Subject: RE: Request for DSAT Training

 
 
   
     

 

 

 

 

 

 



 

 

 

   

 

 

 

Finis; I . ..  . 
Please coordinate your visit wit Ian Eager? U30- 2523
Thanks
NP
April 09, EUR DSAT (and Dr Frieden] receives ?rst notice of safety complaint by ARE staff

 

U.S.C. I 

ell-a:-


Cc: Frieden, Thomas {Tom} itDCfODi; ..




26 Sean Date: 2014?09?17 COPY

Page

Specia1917l4

Accession Number

 

[bjzl'SjLIb?Ij?jz

 

 

 

DSAT requests information from CDC R0 about gafeu,l complaint

 

{Responsible Of?cial]:

 

 

 
  

 

   

tered the -:

 

 

Accession Number: Special91714 Page: 27 Sean Date: 2014-09?17 COPY

 

 

of containment: they chose this option and did not wear PAPHs. according to escort ?3?53 as
the second group stood outside the door of room in the clean corridor, the ARB techniciar
inside opened the door to the animal room. As this door closed, a very noticeable puff of air could be
felt coming through the slit in the window out into the clean corridor.

 

 

 

An incident report was rovided to DSAT from CDC. This report states that rairie dogs were
convalescing in the ?113314 holding room after an experiment withvirus. The BMBL states

that all'person's'vvorking in or entering laboratory or animal care areas where activities with 
virus are being conducted should have evidence of satisfactory vaccination. The two groups ofvisitors to
the vivarium included individuals who had not been vaccinated for 

 
 

 
 

in order to determine whether the visitors on Februarv 14 and 16, 2012 were exposed to a select agent,
please provide the following information bv CUB on April 20, 2012:

I Please submit a completed Form 3 along with an executive summari.r {narrative} of events including
tirneiine of what occurred.

- Please provide details on which rooms within the containment block were entered bv the first group
of visitors.

0 Please provide information on the work activities being performed in all of the vivarium rooms

during the time intervals of the visit.

- Whatisfare the requirementis] for entry into the containment bloclt'rI

Explain the procedure for preventing entry of unvaccinated individuals into areas where vaccination
is required.  

. Please con?rm the last time that active work was performed in procedure roon"  prior to the
tour bv the second group. 2523??:

- Provide details on the animal housing used throug - - containment block and including anv

animals housed at the time in animal holding room ibis?? 

II Previous HVAC verification test results provided to DSAT for the Buildingivarium space were
qualitative and lacked room differential pressure trending data. Please provide pressure trending
data for each of the rooms in the vivarium containment block during the time of the second group?s
visiton Februarv 16, 2012.

 

 

 

 

  

 

lfvou have questions concerning this correspondence, please contacto - 3 3'1
Form 3 mailbox at: 

 

6
On all correspondences regarding this investigation, please be sure to includc{ as

well.

 

 

 

Thank vou in advance for vour cooperation and collaboration in this critical investigation.

 

momma coc provides documents to osar

Accession Number: Page: 28 Sean Date: 2014?09?17 COPY

 

Good Afternoon 3 

 

Per your e-mail and attached letter oprril 13, 2012, please ?nd attached the CDC response to you Q,
request for me to provide additional information regarding incidents that occurred in the Building 
Vivarium during tours on February 14 and February 15, 2012.



 

 

 

 

CDC Response to
DSAT Request 

 

Resectfully submitted,


  

DSAT Requests meeting with CDC RD

cocroPl-iperosan
I I I

    

 

lcocroPHF-erosm

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff
on tomorrow at 1:30pm to discuss DSAT concerns following our review of the information received April
20, 2012, related to the incident ofthe Buildinirvarium Tours. Again, my apology for the short
notice, and thank you in advance for your Support and considerationls] to DSAT's requests.

PS: I am not in the office at this writing, this message is being sent via my Biack?erry. Feel free to
respond at your earliest convenience. Most 

 

April 25 2012 Meeting Roster
use. a 

 








Howard, William {Bill} 

 

 

 

Accession Number: Special91714 Page: 29 Sean Date: 2014-09?17 COPY

   
  
 

 
2E2alhfilb?fii?j,?


I 

Black, Carolyn 
Bowen, Ken L. 
Probst, Paul E. 
Monroe, Steve 

April 26, EUR Meeting follow?up

      

Frorn: 
Sent: Thursday, April 25, 2012 05:40 PM
To thiiaxiz use. - I

Cc 

Sublect: follow up to 4125,1201: meeting

  

  

Based on our discussions yesterday, as part of our information collecting process, 1 would like to request
- - ws with the following people:

  

2] Dr Nathaniel Powell

3} 3?4 ARE. workers that have duties in this rea

the members of DSHE andfor BFD who participated in the most recent HVAC functional testing of
this lab {limit to 3-4 staff members from each]. We do not need to interview supervisors at this time.

 

We would like to meet with these individuals separately next week. If possible. we would like to
schedule 15-20 minute interviews in the early afternoon pmi any day next week. Of course, we
will try to accommodate any schedule con?icts. Depending upon the final number of individuals, we
anticipate being able to finish by Wednesday. But should the need arise, we can interview people later
in the week. Please send [him]: the names and proposed times that these people can be available.

  

In addition, i would appreciate it greatly if you could provide me with the following
informationfdocumentation;

the date when this lab was last tested for proper air?ow,

2] any documentation of this test,

3} the date when the lab was decontaminated prior to the reported air?ow deviation.

Ill any documentation regarding the decontamination procedures and veri?cation of these processes,
5] speci?c entry requirements for thsuites when the labs are hot and cold,

5) speci?c entry requirements for the clean corridor areas outside of the lab suites

My apologies if you have already provided any of this information in the documents currently under
review.

Accession Number: Specia191714 Page: 30 Sean Date: 2014?09?17 COPY

We would also like to conduct a series of relatively simple tests of air?ow patterns on this lab and
several others in the same general area next week. We propose to stand outside of the containment
space in the clean corridor with smoke sticks and verify the direction of air?ow while the inner door
inside the containment space is opened and closed in the same manner that caused the anomaly
observed by the visitors. We are not requesting any failure scenario testing, any HVAC system
manipulations or any other mechanical procedures to be performed during these tests. We will need
someone from either ARB or DSHE to simply open and close the inner door for various time intervals
while we observe the smoke patterns from outside of the lab area. These activities should provide useful
information about the current status of the ventilation system function.

If possible. we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

Division of Select Agents and Toxins

 

siaorzotz Interviews (conducted biylm?m U30 2523ihi-m3?i?i 

Good Afternoon
Please see below for the interview schedule for this week?s interviews.

Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:00 am.
Individual: 0r. Nathaniel Powell

 

 

Tuesday, May 1 Location: Building 24, Room 11-101i5. Time: 10:30 am.
individua

Tuesday. May 1 Location: Building 24. Room 11?10115. Time: 11:00 am.
Individuall revs: I

Tuesday, May 1 Location: Building 24, Room 11-101A Time: 11:30 am.

Individual:

  

is currently on leave of absence through June 2012 and has specifically and personally
conveyed to her line management in 05R that she does not wish to discuss matters related to the
Building facility with anyone.

Wednesday May 2 Location: Building 20, Room 2111 Time: 1:00 p.m.

   
   

 

 

Individual: [Elf-31142 U30. 2
ESE
Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:30 pm.
lndividual1l revs: I
Thursday. May 3 Location: To Be Provided Time: 9:00 am.

individual

Accession Number: Special91714 Page: 31 Sean Date: 2014-09?17 COPY

lb:
Thrire?au "3 Location: TO BE Pr??dldEd Time: 

252mm

 

 

 

 

The smoke test that you re uested to take place on Thursday morning will start at 10:00 am. Members
ofAREi, OSHE, BFC- and th [bl'l'?l of?ce will be available to assist.

 

Other documentation that was requested in your email ofnpril 26 is forthcoming,

Sincerely,

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus

Ghservationsffindings of the DSAT Investigation

1} The major concerns raised by any potential safety complaint or potential release involving a BSAT are
the potential for harm to public health and the potential exposure of laboratoryI workers to biohazards.
Based on a review of the information collected during this investigation, th re wa no credible evidence
that there was any occupational exposure or release of any BSATs from the [(32342 suite during the
incident that occurred on February 16, 2012.

  

 

2} There is evidence that there was a malfunction in the processes that maintain the inward directional
airflow into the space. It has been con?rmed in tests performed by inspectors that the airflow
control process appears to be functioning properly at this time.

There is some disagreement between the eyewitnesses of the event and CDC safety staff with regard to
the magnitude of the air?ow reversal that was observed by the trainees. In reports from these
eyewitnesses, the airflow reversal was described as ?a very noticeable puff ofair? while the reports from
CDC describes the reversal as ?a small "puff" of air?. While neither of these views is quantitative, the
contrast should be noted.

4] There are deviations f. om the NIHICDE authored guidance found in the BMBL with respect to the design
and operations of theEsuites in the Buildingivarium. Specifically, the BlleL states that, ?Doors
to areas where infectious materials andr?or animals are housed, open inward?. As seen in the exit doors
in the diagrams provided with this document, doors opening into the central corridor open outward.
This condition, while listed on the annual validation checklist as an item to be examined for these rooms
is left blank on the document.

 

The second deviation from the BMBL guidance is the requirement that 'Entry into the containment area
is via a Emmi-:42 U30 entry, which constitutes an anteroomfairloclc and a change room. Showers may be
considered based on rislt assessment. An additional [33133142 U-S-C access anteroom or (?31333342 U-S-C-E
autoclave may be provided for movement of supplies and wastes into and out of the facility.?

 

   

Accession Number: Specia191714 Page: 32 Sean Date: 2014?09?17 COPY

While there is a anteroom provided for entry from the outer corridor, there are also
additional doors located into these labs from the outer corridor that permits entry directly from the
corridor into the laboratory. it was one of these doors through which the transient airflow reversal
occurred. These doorsare used to move clean cages into the suites during operations including areas
used for work with other agents besides W's-'12 U-S-C- 2528"? and TB.

 

    

When asked about this procedure, DSAT inspectors were told that a risk assessment was performed that
allowed this work flow to be permitted. However, there was no written copy of this risk assessment
available. Some concern about the discrepancy between the BMBL guidance and this activity was
detected during interviews with workers.

5) There were also some indications that all workers did not clearly understand the basis for the
containment practices in use in the vivarium. For instance, one worker thought that the correct direction
ofairflow between the central corridor and the contaminated animal holding areas was opposite to the
correct direction. Given the heavy reliance on visual indicators for detection of air?ow anomalies rather
than electronic sensors commonly used in high containment facilities in the US to detect airflow
reversals, this lack of understanding of correct airflow represents a potential safety risk.

6) The reliance on visual monitoring of air?ow rather than use of sensor based technology, raises several
other concerns. First, the mechanical problem that resulted in the ?very noticeable puff of air? observed
by the trainee had previously escaped detection. While it is possible that the defect may have
originated on the clay of the incident, this scenario is extremely optimistic. More importantly, this raises
the questions of how long had this condition existed and how long would this problem have continued
to exist before detection, Fortunately, the laboratory was not operational at the time ofthe incident and
ironically, the observation made by the trainee has allowed the problem to be identi?ed and corrected
before the lab began to work with infectious agents again.

There was very meager data available to review regarding the annual facility safety veri?cation process.
After examination by the DSAT facility reviewer, the data provided to DSAT does not meet our current
expectations. I have attached a copy of the results of these verification documents given to us below.

viv  Dec 11

.ar

sl During the meeting held on April as ten, several individuals noted that they
were not informed about the training activities associated with the incident and expressed concern. As
agreed at this meeting, this concern is noted in this report. However, senior CDC personnel were
notified and agreed to these activities in advance. DSAT regrets that this arrangement was not
communicated effectively.

Accession Number: Specia191714 Page: 33 Sean Date: 2014-09-17 COPY

would be permitted:

 

9] We were told that no future training activities in the  

10} We were treated with respect and received professional cooperation bv the others involved
with this effort. 

Summary

. . . . .

DSAT conducted a review of circumstances surrounding an allegation that a laboratorv in Building at
the CDC Rovbai campus was operating under conditions that were unsafe. Based on the report of a transient
airflow reversal from the laboratory through a corridor door. concerns were raised about the possibilitv of an

exposure to infectious agents.

After reviewing documentation related to the status of the laboratorv, interviewing staff members and
conducting tests of the ventilation svstem performance, there does not appear to be any reasonable basis to
conclude that there was a signi?cant exposure to infectious agents or am; release of ESATs outside of the
primary containment barriers of the facility. In addition, the mechanical problem that caused the transient
airflow reversal has been corrected and verified to function properlv.

Accession Number: Specia191714 Page: 34 Sean Date: 2014?09?17 COPY

The following information is provided in response to your request of April 13, 2012, RE: incidents During

Visitor Tours ofthe Building fivarium
42'
0.3


 

 

 

 

1} Please find attached a Form 3 along with an executive summary {narrative} of events including a
timeline ofwhat occurred. It should be noted that a risk assessment conducted by the entity
Office of Safet Health and Environment, the and the Program registered for use

I 1 did not indicate that a Form 3 reportable event occurred during the tours

based on the fact that Room had been decontaminated for annual facility maintenance

activities and no work with virus occurred in the room between the room decontamination and
the tour dates of February 14 and February 16, 2012. In accordance with the attached DSAT

HVAC verification guidance (fourth attachment below}, a transient excursion

does not necessarily mean that a reversal of overall airflow for the containment block has
occurred. It should also be noted that the prairie dogs that were housed in Roomat the
time of the air puff incident on February 16, 2012, were naive prairie dogs that were transferred
into the room in January 2012 from Lawrenceville (where ARB maintains naive animals] as per

 
 

  

the attached log record.


Signed Form
B-Vivarium Airflo. ..

      

Airflow Issue

centers Tm Letter Narrative Summa. .. Verification 

(2}.doc
HF

'Jl'?l

Naive
Log-04202012.pdf

2] ARB has provided information that the following locations were entered by the first group of
visitors on February 14, 2012.

 

Response: A floor plan of the vivarium is attached. i recommend contacting Imam 

to complete details on route taken on February 14, 2012 tour. The information provided below
related to room entry was obtained by ARB staff after reviewing the Personnel Log in Sheet for
the Buildin ivarium:

in Information rumented on the Personnel Log Sheet indicated escorted visitors entered

[0:93:42 . .
RoomU.S.C.?2?2a This room was unassugned, did not have animals present and was not hot on

February 14, 2012.

 

 

 

 

  

   
   

a;

{bi 
Narium_lay Bid ivarium__Log
out_usagegAPR2012 _5heets_23NOV11-3i

 

Accession Number: Special91714 Page: 35 Sean Date: 2014-09?17 COPY

3] ARE has provided the following Information regarding work activities being performed in each of

the vivarium rooms on February 14, 2012 and Februarvr 16, 2012. The registered locations in the
[boil-:42 U.S.C. 2523M:

  

a Vivarium are highlighted in yellow below.-

 

In Response: The following work activities were performed in the Building ?v'arium on

 

 

 

 

 

I I use. 252mm Ianim'ais maintained in tubs.
0 (Unassigned)

The room was'emptv. The room was not hot.
6" j. libji33242 usc. 252mb} I

 

I The room was empty. The suite was'not hot.
0 Roinnassigned)
II The room was empty. The suite was not hot.
use. 252m; I
Animals maintained in the room. The suite was hot.

 

  

4] ARB has provided that requirements to enter into the Buiiding Vivarium containment
block are as follows.

Response: Entry requirements are dependent on the location ofthe studv within the vivarium.
The following information is providedRooms Tvvek suit, PAPR head-cover bonnet, 2 pairs of gloves,-

inner shoe'covers, outer shoe covers, facility shoes 

o: When the suites'are hot, [mm vaccination required'forl I
entifv," Tvv'ek headcover bonnet, outer shoe cover, inner shoe cover, 2 pairs

of'gioves,? sielco'nd'ou'ter smock When handling animals, facilitv shoes

. Tvvek suit, PAPR with head cover bonnet, inner shoe covers, outer shoe covers,
facilitv shoes

0 Note: Rooms do not currently contain animals. Specific entrv
requirements will be protocol driven

I Clean corridorr No PPE is required in this area

  

 

5} The procedure for preventing entrv of unvaccinated individuals into areas where vaccination is
required as provided bv ARB is as follows.

Accession Number: Special91714 Page: 36 Sean Date: 2014-09?17 COPY

 

[b13342 U.S.C. 252aih}

 

 

Ille?'s'osoerl

c. Training

 

6) ARE has provided that the last time active work with infectious agents was performed in
bj:i3}:42

 

procedure room prior to the tour by the second group as follows.

Response: The last active work in was holding of naive prairie dogs beginning Januarv
2012 as per the attached log. Since the most recent decontamination in December
2011fJanuarv 2012, no infectious work has taken place i Naive prairie dogs were
moved into the area in Januarv 2012 but no infectious work occurred with these
animals from the decontamination to the period of the tours.

7r 

Naive Animal


7) A33 has provided details on the animal housing used throughout the containment block and

 

 

 

including any animals housed at the time in animal holding room 03g as follows.
Response: Animal housing throughout theI ?12:83:42u.s.c.s2a2aih: Iconsists of the
following:

a Individual ventilated caging supply and HEPA exhaust)
This type of caging is used to house prairie dogs
0 Duoro units with metal cages placed inside (HEPA filtered exhaust}
This type of caging is used to house ferrets
- Tub holding containers (This type of caging is used to house groups of rairie dogsU.S.C.
Naive prairie dogs were malntalned in this type of housing in Rooml 2623ih':
February 16, 2012.

 
     

 

Accession Number: Specia191714 Page: 37 Scan Date: 2014?09?17 COPY

8) BFO has provided the following response to the request for pressure trending data for each of
the rooms in the vivarium containment block during the time of the second gmup's visit on
Februarv 16, 2012. Additionally, Dr. Paul Meechan, Director, OSHE, has conveyed that there is
no requirement to maintain trending data for pressure differential readings. Pressure
differentials are not airflows and there is no requirement that they be continuouslv monitored

and recorded.


Iv'lvariurn Door
Pressure 

Accession Number: Special91714 Page: 38 Sean Date: 2014-09?17 COPY

53411?3913 53

 

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"a fnluEH71-3"

CLINICAL RECORD OF ANIMALS

REMARKS

U.S.C. 

 

 

 

 

 

 

 

 



 

1N VESTIGAETO

[b38142 USE. 2523M:

SPECIES Frame DOG

    
 

 

 

 

 

 

 

 

  

 

 

 

 

 

 

 

 

 

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ORD 01: ANIMALS

CLINICAL REC
Vawth-LM'M

nomad Jun-5 13:94. CDC Mute mahal EFL Emma-qr.

Accession Number: Page: 39 Sean Date: 2014?09?17 COPY

 

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CLINICAL RECORD OF ANTMALS 

REMARKS

        

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.s.c.?2523mj: Prams Dag
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INVESTIGATORI - 
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ORGANIZATION 11,342 ?252 GROWH Hui-35.42 0 
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RECORD OF ANIMALS

5MB (EL Ran-m: June- 199-1. CDC .hdobu  an. Emmi: Vcakzn? me?y 3005

Accession Number: Special91714 Page: 40 Sean Date: 2014-09?17 COPY

 

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DATE REMARKS

011'244?2012

 

 

 

 

 

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ELIMCAIRECGRD 0F ANIMALS

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Accession Number: Special91714 Page: 41 Sean Date: 2014-09?17 COPY

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Accession Number: Special91714 Page: 61 Sean Date: 2014-09?17 COPY

 

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Accession Number: Specia191714 Page: 69

We will be working to generate the information requested and will provide itas soon as possible.

Best regards,

 

 

 

nr~n 

 

 
 


Sent: Thursday, April 26, 2012 06:40 PM
To: [biliajrzata 5.0. 252mb: 

   

Cc: 


Subject: follow up to meeting

Based on our discussions yesterday, as part of our information collecting process, I would
like to reduest your help arranging interviews with the following people:

lbjf?l

 

1)

 

 

 

2) Dr Nathaniel Powell



3) 3?4 ARB workers that have duties in this uses

 

4) the members of OSHE and/or BFO who participated in the most recent HVAC
functional testing of this lab (limit to 3-4 staff members from each). We do not need to
interview supervisors at this time.

We would like to meet with these individuals separately next week. If possible, we would
like to schedule 15-20 minute interviews in the early afternoon {1-2130 pm) any day next
week. Of course, we will try to accommodate any schedule conflicts. Depending upon the
final number of individuals, we anticipate being able to finish by Wednesday. But should
the need arise, we can interview people later in the week. Please send [saggy-gee the
names and proposed times that these people can be available.

 

 

 

 

In addition, I would appreciate it greatly if you could provide me with the following
information/documentation;

the date when this lab was last tested for proper airflow,
2) any documentation of this test,
3) the date when the lab was decontaminated prior to the reported airflow deviation,

4) any documentation regarding the decontamination procedures and verification of
these processes,

Scan Date: 2014-09?17 COPY

 

[5133142

5) specific entry requirements for the Essa-St? suites when the labs are hot and cold,

 

 

 

6) specific entry requirements for the clean corridor areas outside of the lab suites 

My apologies if you have already provided any of this information in the documents
currently under review.

We would also like to conduct a series of relatively simple tests of airflow patterns on this
lab and several others in the same general area next week. We propose to stand outside of
the containment space in the clean corridor with smoke sticks and verify the direction of
airflow while the inner door inside the containment space is opened and closed in the same
manner that caused the anomaly observed by the visitors. We are not requesting any
failure scenario testing, any HVAC system manipulations or any other mechanical
procedures to be performed during these tests. We will need someone from either ARB or
OSHE to simply open and close the inner door for various time intervals while we observe
the smoke patterns from outside of the lab area. These activities should provide useful
information about the current status of the ventilation system function.

If possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.
{bli?l

 

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

[b?l?l

 

 

 

ibjl?j

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and
toxins.

Accession Number: Specia191714 Page: 70 Sean Date: 2014?09?17 COPY

 



 

Per vour request of April 25, 2012, the following documentation is provided with this submis
was last tested for proper airflow bv BFD was December 21, 2011.

 

1) The date when this lab 5 
OSHE veri?ed proper airflow on January 9, 2012.
f? attachments are provided by the third 'pdf? is

2) Any documentation of the test-?the first two 'pd
the OSHE verification of airflow on January 9, 2012


'u'iv . Dec 11 I 'u'ivarium
was 

3} The date when the lab was decontaminated prior
using Spor-Klenz}. The OSHE procedures for Spor-

  

to the reported airflow deviation {December 5, 2011
Klenz decontamination are provided below.

i -I
E.

   

LABORATORY
SURFACE 
. .
The specific entrv reqtnrements for the .304; surtes when the labs are hot and cold as well as for the clean
corridor areas outside of the lab suites will be forwarded under separate cover later this afternoon.

Best regards,
[0:83:42 USO. 262801:

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta, GA 30333

[0133242 U.S.C. 252301}

 

 

 

 

71 Sean Date: 2014-09?17 COPY

Accession Number: Specia191714 Page:

 

 

Page 071

U.S.C. 262a{h)

 

 

Good Afternoon

Please see below for the interview schedule for this week?s interviews.

 

 

 

 

 

 

 

 

 

 

Tuesdav, Mav 1 Location: Building 24, Room 11-101A Time: 10:00 an individual: Dr.
Nathaniel Powell (one;
Jaime" Mn 1Location: Building 24,Rddm 11-101A Time: 10:30 a.m. Individual:
Tuesdav, Mav 1 Location: Building 24, Room 11-10111 Time: 11:00 am. Individual:
llbli?j I

Time: 11:30 am. Individual:

Tuesday, May 1 Location: Building 24, Room 11-10114

.
is currently on leave of absence through June 2012 and has specificallv and personally

conveyed to her line management in DSB that she does not wish to discuss matters related to the Building 

facility with anyone.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- nesda May 2 Location: Building 20, Room 2111 Time: 1:00 pm. Individual: 
522523
tjl?lzl'iiednesdav, Mav 2 Location: Building 20, Room 2111 Time: 1:30 pm. Individual: 
i 
[bii?i
War, Mav 3 Location: To Be Provided Time: 9:00 a,m, ndioiduai;
Thursday, May 3 Location: To Be Provided Time: 9:30 a.m.lndividua :

 

 

The smoke test the? b, requested to take place on Thurs
OSHE, BFO and the [31:32 office will be available to assist.

  
   
   

day morning will start at 10:00 am. Members 

 

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 

U.S.C. 252301]

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop 

GA 30333
[0:13:42 USE. 252aih]

 

 

 

 

Accession Number: Specia191714 Page: 73 Sean Date: 2014-09?17 COPY

Of?ce of Health and Safety

 

$133242 U.S.C. 2?2aih}

 

 

_aboratory Validation Checklist

 

. 'b 3 :42
Laboratory Location: Lilli-3E1 Flew?r? we r1 or:

Laboratory Supervisor: rectum 

 

Nile Comments


2:

 



Laboratoryr separated from unrestricted tra?ictlow in building
Access to laboratory.r through two self-closing lockable doors
Interior surlaces oi walls. floors. and ceilings are constructed lor
easy cleaning and decontamination. Surfaces should be smooth.
impermeable to liquids. and resistant to chemicals and normal
disinfectants used in the area

All penetrations in laboratory sealed or sealable for
decontamination

Hands-tree or automatically controlled sink available within 

 

 

(C


 

 

q:


 




 

 

 

Hgnlainment zone 
Aerosol producing equipment contained in devices that exhaust air 
through HEPA ?lters before discharge into the laboratory 
Vacuum lines are protected with HEPA filters Mr

 

Additional environmental protaction personnel showers.
effluent decontamination] is in place where recommended by 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

agent summary statement, risk assessment. site conditions or 

other applicable federal. state. or local regulations .

Supva and exhaust HEPA ?lters certi?cation current or?

Proper directional airflow verified pr?

Visual indicator of directional airilow availm w"

All APR doors working properly," and other doors self closing

All shelves secured 

Bench-tops waterproof and resistant to acids. alkali. organic 

solvents and heat 

Chairs covered with non-porous material w?

Adequate illumination provided 1.2"

Fire alarm system present

Sprinkler heads free and unobstructed 

Unobstructed emergency ingress and egress 

Animal cages are washed in a cage washer for ll?? Ease Lg?;

Animal room doors open inward 1
Protocol in place to keep animal room floor drain traps lull 
incinerator present and operational for waste management tux?,

 

 

 

 

 

 

CommentsiRecommendations

easinth \lta rEqu?n?h?-t? 1mg, Wmure sweequ mum's secured 
etbdaec,

 

 

 

 

 

 

 

 

ib:i[3::242 U.S.C. 252aih]

 

 

i

 

 

Safety official signature

I - aw;? 
Date validatton campictcd: 

 

Accession Number: Specia191714 Page: 79 Scan Date: 2014-09?17 COPY

 Office of Health and Safety

 

U.S.C. 262aihj: II Ivalidatfon Checklist

 

Laboratory Location: HCL vivariurnIil3?ii33'i?i2 U-S-C- 2523i?)

 

Laboratory Supervisor:

 

DivisioniSection: 3 3"

 

Persons present during Validation: lii3?33343m :Ilibi?i?ii 

 

Nita Comments

 

Administrative documents, signs and labels

Laboratory door property posted for hazards: a) Bioeafety Level.
b) Point of contact, c) immunizations required. d) Radiation 
hazards. a} Chemical hazards: and fl Laser hazards
Laboratory equipment properly labeled (biohazerd, radioactive. Hr"
toxic, etc.)

All personnel have had OHS designated training
Facility and site speci?c Biosefety manual available

 

 

 

 

are contexth

 

 

Chemicals

Chemicals properly labeledand segreqaled 4.:
Flammabies properly labeled-and stored

Corrosives progeny labeled and 

Spill kit available foe-cm? L.
MateriaLSaiety??ata Sheets available

Site?s'preciilc Chemical lqulene plan available

 

 

 

 

 

 

 

 

 

Waste management .

A method for decontaminating all laboratory wastes is available in"
the facility within the laboratory

incinerator present and operational for waste manaqement
Ei'lluent decontamination available

Discard pans and autoclave beds available

Sharps containers available

Waste disposal guide available

Appropriate decontaminant available

 

.1.

 



 

 

 



 

 



'i lam-t

 

 

 

1

Personal protective equipment

Unobslructed eyewash available and identified

Safety shower available and identified

Appropriate personal protective equipment available
Personnel have been trained on usage of PPE

Personal shower available

Chemical decontamination shower operational (lib? Ionlyi
Breat i tanks and compressors operational and airlines in 
piece 3 only]
Backup breathing air tanks present and operational lib? Ionlvi 

 

 

 

 

- I

 

 



 

   

 

 

 

Primary containment

BSC Certification current

Frontgrill and exhaust ?lter unobstructed

BSC containment not affected by room air or location
Necropsy HEPA filters certi?cation current

Animal holding unit HEPA filter codification current

 

 

 

 

 

rrtq?

 

 

 

 

 

 

 

 

Accession Number: Specia191714 Page: 80 Scan Date: 2014-09?17 COPY

Public Health Sentine-
Centers for Disease Controt
and Prevention (CDC)

 

 

 

v?ulm' 
Url
 oF HEALTH 3. HUMAN 
out?
TO. use. zssarh; I
Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mail Stop A46

Atlanta. GA 30333


Director, Division of Laboratory Policy and Practice

 

 

 

FROM:
DATE: April 20. 2012
Incidents During Visitor Tours of the Building Vivarium
on as requested in the DSAT letter of April
-Royba] Campus] [b36142 use. 262mm

SUBJECT:
The purpose of this correspondence is to provide informati
'13. 2012. to the Centers for Disease Control and Prevention

bf DSAT sent an email to OSI-IE and ARE capressing

[bll33242 USE. 252mm
As way of background I would like to describe important actions taken related to this event.

 

 

a On February 16. 2017' 
cancel-us about the event in question. This email did not include anyone from the SA
Compliance Of?ce. OSHE investigated the circumstances and determined that there had been no
potential occupational exposure.
a As a result of this detennination- there was no of?cial noti?cation sent to DSAT.

. a result of the email sent on April 9, 2012, additional reviews of this incident were conducted
and summary'documents of the ?ndings were prepared. I shared these documents with Dr.
Robbin Weyant on April 12, 2012, and be indicated that would be opening an

. requesting the attached response

a A

 

I sent an email to the Form 3 email address requesting
ta?" was present at the time of the incident.

investigation.
a On April 13, 2012 we received the email fro

by April 20, 2012;
a 011 April 17, 201.335 libit?Biz? use. 252mm
additional information related to the event as DSAT 

as of Friday April 20, 2012, we have not heard back. If this incident is determined by DSAT to
be reportable, we respectfully submit we will need this information before we can proceed

further in our investigation.

In: 

.1- A mm't 

Accession Number: Special91714 Page: 81 Sean Date: 2014-09?17 COPY

 

U30. 262mm
requrre anything further from us please do not hesrtate to contact me or

 

Respect?rlly submitted,

Director

Division of Laboratory Policyr and Practice

Laboratory Science Policy and Practice Program Of?ce

Office of Surveillance, Epidemiology and Laboratory Services
Centers for Disease Control; and Prevention

1600 Clifton Road, NE, Mail Stop E-SG

Atlanta1 GA 30333

Telephone: 404498?6409

Ehclm?f?e?om

REV. TIZDOJ.
do:

Accession Number: Page: 82 Scan Date: 2014-09-17 COPY

 

ibli?j;

 

 

 

?3:13:42 U30

252mb:   



ibii?l

 
  

We will be working to generate the information requested and will provide it as soon as possible.

Best re ards,


 

    
   

 

 

    

Sents'ihursda A ril 26, 2012 06:40 PM
To: U.S.C. 252mb} 
Cc: [bi-[61> (cocioPHeRrossr);

(CDCIOPHPRIDSAT)
Subject: follow up to 4,125/2012 meeting

Based on our discussions yesterday, as part ofour information collecting process, 1 would
like to request your help arranging interviews with the following people:

[bji?j

 

 

 

 

 

 

 

 

1)

2) Dr Nathaniel Powell 

3) 3-4 ARB workers that have duties in this  area

4) the members of OSHE and/or BFO who participated in the most recent HVAC

functional testing of this lab (limit to 3-4 staff members from each). We do not need to
interview supervisors at this time.

We would like to meet with these individuals separately next week. if possible, we would
like to schedule 15-20 minute interviews in the early afternoon (1-2:30 pm) any day next
week. Of course, we will try to accommodate any schedule conflicts. Depending upon the
final number of individuals, we anticipate being able to finish by Wednesday. But should

the ?93d arise. we can interview people later in the week. Please sen  
names and proposed times that these people can be available.

     

In addition, I would appreciate it greatly if you could provide me with the following
information/documentation;

l) the date when this lab was last tested for proper air?ow,

2) any documentation of this test,

3) the date when the lab was decontaminated prior to the reported airflow deviation,
4) any documentation regarding-the decontamination procedures and verification of

these processes,

Accession Number: Specia191714 Page: 83 Sean Date: 2014-09-17 COPY

 

5) specific entry requirements for the . suites when the labs are hot and cold,

6) specific entry requirements for the clean corridor areas outside of the lab suites
My apologies if you have already provided any of this information in the documents

currently under review.

We would also like to conduct a series of relatively simple tests of airflow patterns on this
lab and several others in the same general area next week. We propose to stand outside of
the containment space in the clean corridor with smoke sticks and verify the direction of
airflow while the inner door inside the containment space is opened and closed in the same
manner that caused the anomaly observed by the visitors. We are not requesting any
failure scenario testing, any HVAC system manipulations or any other mechanical
procedures to be performed during these tests. We will need someone from either ARB or

DSHE to simply open and close the inner door for various time intervals while we observe

the smoke patterns from outside of the lab area. These activities should provide useful
information about the current status of the ventilation system function.
If possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

 

 



 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Well-lama Georgia 30333

 

 



 

 

Accession Number:

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and
toxins.

Special91714 Page: 84 Sean Date: 2014-09?17 COPY

 surrey-mp
a 

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
tag Centers for Disease Control
?am and Prevention (CDC)
Atlanta GA 30333
January 13. 2009
I ?31342 2523??; I tpj:r3j::42 use. 252nm:

 

 

 

 

Centers for Disease Control and Prevention 
1600 Clifton Road, MS F05
Atlanta. GA 30333

I U.S.C. 252301} I

I

 

CFR 73.16 (Transfers)

Thank you for your notification on October 22, 2008 to the Centers for Disease Control and
Prevention  of Select Agents and Toxins (DSAT) of the unexpected delivery of
onevialofi l?

on October 10. 2008. You stated that as soon as you became aware or me
shipment you immediately contacted  of our office on October 10, 2008.
DSAT further understands that your entity will be adding these received select agents to your
entity?s inventory. -

   

Section 73.17 (Records) requires that an entity maintain complete records of transfers for three
years. Please submit to DSAT an Form 2 transfer request form to document 
receipt of one vial 

The DSAT would like to thank you for reportingthis apparent transfer violation and has
determined that no further action will be taken in this matter.

 

if you have any questions concerning this letter, please contact Irma: 
with the DSAT at or your designated DSAT Fill: Manage-,1- a rulr3;:42 

 

Robbin Weyant, CAPT, USPHS

Director

Division of Select Agents and Toxins

Coordinating Office fer Terrorism Preparedness and
Emergency Response

This document is intended torthe exclusive use of the recipientts) named above. It may contain sensitive information that is protected.
privileged. or confidentialI and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It
you are not the intended recipieht{s}. any dissemination. distribution. or copying is strictly prohibited. if you think you have received this
doCument in error, please nolitythe sender immediately and destroy the original.

Accession Number: Special91714 Page: 85 Sean Date: 2014-09?17 COPY

Public Health Service

 

 

Centers for Disease Control and Prevention (CDC)
Office of Safety, Health and Environment
Atlanta GA 30333

.Ap?112,2012

   
  

Late in the afternoon on Februaryl?, 2011 OSHE was notified of a potential air ?ow incident in
the Vivarium. OSHE representatives responded ?rst thing the near mornin to
investi ate. The incident occurred while viewers were in the ?ole rridor 9: -v 
mm . animal holdin areas through the procedure room door 
assigned to the $533563 branch. While viewing prairie dogs held within the holding room, a
door between the holding room and procedure room closed with greater force than required,
sending a small ?puff? of air out through the slotted window door on the clean  
and apparently into the face of a DSAT visitor. At the time of the incident, I 
Wm? U30-  prairie dogs that had just been moved in a few weeks prior. I: 2525" had also
been in December of 2010 and no I  . had been worked with in that room since the
The room was clean of an irus and the animals being housed in
?33342 U-S-C- i 2523f??- irus (previously tested in November 2010 and January

    
 
    

 

  
 

     
    

     

 

  

 

 

 

 
     
    

2011}

The evaluation by OSHE was that although the "puff" of air out through the-slotted window
should not have occurred, there was no exposure risk to those at the door during the incident. All
compliance parties involved determined no exposure occurred and thus it did not trigger the
requirement that exposures be reported to DSAT. A call was made to BFO to have the doors in
the suite examined and door closers were adjusted and tested.

Corrections have been made and all animal room doors close properly without causing an air?ow
disruption on the [53.3.33342252, corridor. After action items included discussions with ARB to
continue to monitor the doors and if at any time in the future any closure issues were observed
they were to contact the   or the OSHE Biosafety Manager. BFO has also reviewed
the PM for this area to ensure that door closers are evaluated annually for adjustments to preper

set points.

 

 

 

[b1?[3i242 U.S.C. 252301}

 

 

 

Office of Health and Safety

Accession Number: Specia191714 Page: 86 Sean Date: 2014-09?17 COPY

 

was: 

 

 

 

 

 

 

 

From: Powell, Nathaniel 

Sent: Monda A ri109.2012 3:?321312242 [eta-:42 


Subject: FIE: Fiequest for DSAT Training

was:

 

 

 

 

 

Please coordinate your visit with ?333142 

Thanks

NP

 

 

From: 

Sent: Monday, April 09, 2012 10:49 AM

To: Powell, Nathaniel (CDCJOIDINCEZID) ME:

Cc: lief-3:442USE-Warm I 
Subject: Request for DSAT Training

 

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to schedule a

training session for the last week of April, 2012 for DSAT FTEs (5 participants]. I am waiting to hear backf ?315decide on an exact date. To answer your question: the requirements to enter the u?ci? last time

were TB test and proof of program! respiratory fit test. Again thankyou for your support.

  

 

1

Accession Number: Specia191714 Page: 87 Sean Date: 2014-09?17 COPY

Report

 

 

 

 

 

 

 
 

To: (cocroPHPerosan

From: (CDCIOPHPHIDSAT)

cc:  

Date: 5Ni2012 

Fle: Report on the case with the rainingitour for the Biological Select

Agents and Toxins (BSAT) lnteragency Inspector Training Program.

 

On July 21 2010 the President issued EO 13546 ?Optimizing the Security of Biological Select Agents
and Toxins." This EO highlights the importance of Biological Select Agents and Toxins (BSAT) research
to national security and establishes specific requirements for the possession and use of BSAT. Section
6a "Coordination of Federai Oversight for BSAT Security"of EO 13546 requires that "the policies and
practices used to secure BSAT are harmonized and that the reiated oversight activities of the Federal
Government are coordinated."

CDC was tasked with designing. developing and implementing a training program that would
assure harmonized practices among federal partners. On June 28. 2011 the Associate Director for
Science at DSAT activated the first Biological Select Agents and Toxins (BSAT) lnteragency Inspector
Training (IIT) Program. The goal of the program is to provide the knowledge, skills and experience to
Federal partners to conduct ?internal? inspections of registered entities they own and operate or fund, or
to conduct joint inspections with CDC and APHIS. The program consists of lectures, and tours of
several sites of bicsafety interest at CDC Roybal campus.

 

One of such tours is done in the . our is a great opportunity of entering the animal
containment facility. and is a critical component of the Biological Select Agents and Toxins 
lnteragency inspector Training Program. With the assistant and support from personnel
DSAT was able to coordinate with the clinic to cover the specific entry requirements for 
area. The requirements included serum banking, proof of enrollment in a respiratory protection program
and TB test. However, serum banking is a policy cancelled by CDC since the beginning of 2012.

  
   

 

 

Because the I a full PAPB and shower out facility, ADS-DSAT was providing another training
session as a prerequisite for the titties his training was "introduction to DSAT's PPE use and
maintenance", given by Biosafety Specialist. During this training session concepts of PPE, and
facility requirements are introduced. Also. PAPR equipment is fitted. tested and provided to accompany

each participant to the training.

 

The first trainingitour session with our  partners was done on October 14th, 2011. The following

W?iciuated in this one session  I

 

 

 

Accession Number: Special91714 Page: 88 Sean Date: 2014-09?17 COPY

For the second trainingitour session with our partners, ADS-DSAT was obligated to clarify the
need for serum banking. According to the new CDC policies since 2012 there is no need for serum
banking; however. Dr Powell Nathaniel (ODOIOIDINCEZID) was reguesting serum banking. This was
clone through several emails and a conference call on February 2, 2012. The participants were:
Weyant, Fiob Nathaniel Black, Carolyn
(cocromrNCEZIo); that?? Nicholson, Janet (secrete/OD);

wits: and ODCIOPHPRIDSAT). It was agreed not
to have serum banking as an entry requirement for th

 

 

  

 

This second trainingftour had 2 sessions; one took place on February 14 and the other on February
2012. All participants entering the animal area were trained, and provided with PAPR's by CDC-
Hm? lThe following people participated in the first tour on February 14'h
at 8 AM: 

[bit-'63 DSAT's SME i: t" 3 was the escort. Participants entered the lab using the provided
PAPP. equipment and showered out following the exit requirements of the lab. For the second
session the participants were given the option of touring the outside clean area of the facility. so they
didn't use the prOVideCm?mw PBDPIE PaniCipatEd in this 53?13?de 0?

February 16?? at 3 AM mm 2525"??

U.S.C. 252mm

 

 

      

 

 

 

., was never informed 01 an Iriclueru Happening
during the tours. At the end of the training I emailed all SMEs on February 23. 2012 (includin

I [113153 Io say thank you for their support replied "It was a joy and a
pleasure You have my complete support" (I am including the of the email as Appendix 

 

On April 2012 DSAT had again the need of an *3 . tour for trainees from the Import Permit group.
During several consecutives days I emailed and oalledl'mi? 'as well as Dr. Powell
requesting their support. On 04r'09f12 I was finally able to con ac r. 'well over the phone. He agreed
to have atour nd asked me to send him an email. in his responding email, he requested me to
coordinate wit [or the tour am including the of the
email as Appendix 2). I emailed all of them, and I received an email back from
informing me of the impossibility of helping us with the training due to an incident that occurred during
the last trainin tour (pdf of the email is attached Appendix 3). On an effort to understand the situation
i contacted I?m; lover the phone [04r10j12i asking him about the trainin issue in the [tb??ag??ritg's'c'
tabs. i also questioned! mini:  th why ADS-DSAT was never informed. Ii 
ntioned that an incident happened during the second tour with the personnel. asked'h?m':
to please provide me with a report of what happened and any corresponding emails fron1 mzra: 
concerning the case. On 04I10i2012 I received an email tron a
correspondence between him and 33?? . (i am including the of the email as Appendix 4).
Until today 05107012012 I haven?t receive any extra information concerning the case from any one.

 

 

 

 

 

 

 

 

   

 

 

Accession Number: Specia191714 Page: 89 Scan Date: 2014?09?17 COPY

 

(Lilla)

 

 

 

 

 

 

  
  
    

 

 

  
 


From: Ircocronomcezro}
Sent: i- 
To: (coorOPHPerosrm; Powell; Nathaniel (CDCIOIDINCEZID)
Cc: homes (Torn) 
. . . (CDCKOS Williams. Allison ..
(CDCIOCODIDSHE) 
Subject: FIE: Flequest for DSAT Training



 

 



 

 

a
From: II

 

(cocroeeperosar)

Sent: Monday, April 09, 2012 10:49 AM

To: Powell, Nathaniel (CDCIOIDINCEZID)

 

I (cocroeHenrosar);Ilbli5l

Subject: Request for DSAT Training

Dr Powell

(cocromrncezm)

Following our conversation from this morning; first 1 want to thank you for your support. We are trying to schedule a
training session for the last week oprril, 2012 for DSAT FTEs {5 participants). lI am waiting to hear back from

020(5)

Accession Number:

1

Page:

Ito decide on an exact date. To answer your question: the requirements to enterthe 
were TB test and proof of program! respiratorytit test. Again thank you for your support.

 

 

(3)42

 

 

90 Sean Date: 2014-09-17

last time

COPY

.111!? 

Public He alth Service

 

 

coolers for Disease Control
and Prevention

June 20, 2012

 

[0:16:42 U.S.C. 252301:

 

 

 

Centers for Disease COntr-ol and Prevention
Atlanta, GA 30333

 

USC. 262801:

 

RE February 16, 2012 incident in the Building

 

 

This communication is in reference to our investigation ofan incident reported to DSAT involving a
potential release of a select agent in a registered space in Buildingn the Roybal campus.
Please find attached our report of this investigation.

Rob Weyant, RBP 
Director

CDC Select Agent Program
1600 Clifton Road, 
Atlanta, GA 30333
1404-7132000

This document is intended for the exclusive use of the recipientis} named above. it may contain
sensitive information that is protected, privileged, or confidential, and it should not be disseminated,
distributed, or copied to persons not authorized to receive such information. If you are not the
intended recipientls), any dissemination, distribution, or copying is strictly prohibited. If you think you
have received this document in error, please notify the sender immediately and destroy the original.

 

{bil?i

 

 

CC:

 

Joseph Henderson 

Accession Number: Special91714 Page: 92 Sean Date: 2014-09?17 COPY

Purpose of Report

The purpose of this report is to describe the investigation of a potential exposure to a select agent caused use. ., 
unsafe operating conditions in an biosafety mm? I located in Budding
3:142 USlz??aihl  on the Center for Disease Control and Prevention Floybal campus In Atlanta, Georgia. The facility

 

 

 

areas covered by this report are registered with the Division of Select Agents and Toxins and
approved for work with Biological Select Agents and Toxins (BEAT). This investigation report, prepared by the
biosafety team is a compilation of interviews, documents and observations made during a site visit
conducted between May 1-3, 2012. As SuCh, information presented in this report has been either taken
verbatim from some of the documents supplied to the team, paraphrased based on the best interpretation that
could be made from these documents, and on-site observations and interviews

Background

On February 16, 2012, a group of government employees participating in the Federal Sel ct Agent Program's

. . miracle . . . . . [bi 
lnteragency Inspector Training (HT) Program toured theaCility located In Building on CDC 5 Roybal
Campus in Atlanta, Georgia. This program was established to support coordination of training tasks prescribed
in Executive Order 13546.

 
 

During the tour, the trainee escort, a DSAT member, observed that a ?very noticeable puff of air could be felt

coming through the slit in the window out into the ?clean? corridor.? This incident occurred while the trainees
31:42 . - -

were in the corridor viewing animal holding areas through the procedure room door of room

lens are provided below for reference. One floorplan illustrates the quadrant of the m,
ibi: i,

do where the Il'lCldEl'lt occurred. The second floor plan shows an enlargement ofthe 
252mb?

 

   

 

 

 

lab area in this quara'nt.

 

[bfr
. . . . . .3314 .
The trainees were standing in the outer corridor near the door connecting the room [15.02. with the interior of the

onr-

laboratory. Entry into this laborator I ?113142 USE-HEM: I as can be seen on the
floor plans between rooms 
(BileLl, a voluntary code of biosafety practice jointly published by CDC and the National Institutes of Health
(NlHl advises that in;:i3;::42 Irequirement 
See p. 82, BMBL (section Di). However, rooms in this vivarium are also: Into

the suite from the clean corridor. This door can be seen above the numeral 2 in the use. s2 abel on the floor plan.

This door is the location where the trainees were standing at the time ofthe incident. This door is equipped with

 

 

 

 
 

The Biosafety and Microbiological and Biomedical Laboratories, ed.

  

 

laboratories.

 

 

 

 

a window and an opening in the frame that allows air to flow into the inner area of the laboratory when the

ventilation system is operating properly. According to the Bl?leL, proper design and operation of an 

laboratory should ensure that "the direction of airflow into the animal facility is inward; animal rooms maintain

 
 

inward directional airflow compared to adjoining hallways.? See p33, Bl'v'lBL {section D6).

While viewing prairie dogs held within the innermost room, the door between the two rooms inside the
laboratory suite closed quickly, causing air to flow out through the slotted window and into the face of the
trainees. Late in the afternoon on February 15, 2012 Office of Safety, Health, and Environment was
notified by DSAT of the air flow incident. OSHE representatives responded the next morning to investigate.

Accession Number: Specia191714 Page: 93 Sean Date: 2014?09?17 COPY

 

U30. 2623ih]

 

 

 

-..- 

 

Accession Number: Special91714 Page: 945 Sean Date: 2014-09?17 COPY

 

[b33342 usc. 252mm

 

 

 

Observationsifindings of the DSAT investigation

1) The major concerns raised by any potential release ofa BSAT are the risks for harm to public health and
the potential exposure of laboratory workers to biohazards. Based on a review of the information

collected during this investigation, there is no credible evidence that there was either an occupational
exposure or a release of any BSATs from the  suite as a result of February 16, 2012 incident._

QR?v-irh?

 

 

 

 

2] There is evidence that there was a malfunction in the processes that maintain the inward directional
airflow into the space at the time of the incident. It has been confirmed by tests performed by DSAT
inspectors that the airflow control process appears to be functioning properly at this time.

3] There is some disagreement between the eyewitnesses of the event and the CDC safety staff with
regard to the magnitude ofthe airflow reversal that was observed by the trainees. in written statements
from eyewitnesses, the air flow reversal was described as "a very noticeable puff of air? while the
reports from CDC safety staff describes the reversal as "a small puff of air?. While neither of these views
is quantitative, the contrast is noted.

 

.bji233142
There are deviations from the BMBL guidance with respect to the design and operations 

9Fi'quh"

suites in the Buildingivarium. First, the BMBL states that, ?Doors to areas where infectious materials

 

 

 

Accession Number: Special91714 Page: 95 Sean Date: 2014-09?17 COPY

andfor animals are housed, open inward, . .  See p82, BMBM {section Dl}. As seen in the exit doors
in the diagrams provided with this document, doors opening into the central corridor open outward.
{See first figure above}. This departure from the BMBL guidance, while listed on the most recent annual
validation checklist supplied to DSAT as an item to be examined for these rooms, is left blank on the
document. This document was dated January 9, 2012.

The second departure from the BMBL guidance is the requirement that ?Entry into the containment area
is via a which constitutes an anteroomfairlock and a change room. Showers ma be
considered based on risk assessment. An additional access anteroom M33142 USO-imam?
autoclave may be provided for movement of su - lies and wastes into and out of the facility.? See p32,
BMBM (section While there is a I: l: anteroom provided for entry from the outer corridor,
there are also additional doors into these labs from the outer corridor that permit entry directly from
the corridor into the laboratory. It was one ofthese doors through which the transient airflow reversal
occurred. These doors are used to move clean cages into the suites during operations including areas
used for work with other agents besidesl {and TB.

 

 

 

 

 

 

 

 

When CDC staff were asked about this procedure, DSAT inspectors were told that a risk assessment was
performed that allowed this work flow to be permitted. However, there was no written copy ofthis risk
assessment available. Some concern amet the discrepancy between the BMBL guidance and this
activity, movement ofanimal cages into a *hot? lab through a single door from the clean corridor,
was detected during interviews with workers.

5) There were also some indications that all workers did not clearly understand the basis for the
containment practices in use in the vivarium. For instance, one worker thought that the correct direction
ofairflow between the central corridor and the contaminated animal holding areas was opposite to the
correct direction. Given the heavy reliance on visual indicators for detection of airflow anomalies rather
than electronic sensors commonly used in other high containment facilities in the US to detect airflow
reversals, this lack of understanding of correct airflow represents a potential safety risk.

6] The reliance on visual monitoring of airflow rather than use of sensor based technology raises several
other concerns. First, the mechanical problem that resulted in the 'very noticeable puff of air? observed
by the trainee may have previously escaped detection. While it is possible that the defect may have
originated on the day ofthe training session, this scenario is extremely optimistic. More importantly,
this raises the questions of how long had this condition existed and how IOng w0u d this problem have
continued to exist before detection. Fortunately, the laboratory did not contain infected animals at the
time of the incident.

7} There was very meager data available to review regarding the annual facility safety verification process.
Records supplied to DSAT to document annual safety verification activities of vivarium HVAC
performance are included in Appendix 1. For comparison, electronic pressure differential data provided
by another entity during a recent investigation by DSAT is also shown in Appendix 2. This electronic
sensor data allows tracking ofdifferential pressures between zones in a suite. DSAT was
told by CDC staffthat no such information is collected or available for our review because it is not a
specific requirement addressed in the BMBL. However, such data tracking does allow retrospective

Accession Number: Specia191714 Pages 96 Scan Date: 2014?09?17 COPY

analvsis of airftows and could have possibly identified the anomaly associated with the airflow

disturbance without relying upon a visual indication of the problem.

8] We were treated with respect and received professional cooperation bv the CDCand others involved
with this effort.

Summary

DSAT conducted a review of circumstances surrounding a report of an incident that may: have resulted in a
potential release of BEAT in an aboratorv in Building the CDC Rovbal campus. Based on the report
of a transient airflow reversal from the laboratorv through a corridor door, concerns were raised about the
possibilitv of an exposure of visitors in the area to infectious agents.

   

After reviewing documentation related to the status of the laboratory, interviewing staff members and
conducting tests of the ventilation system performance, there does not appear to be any reasonable basis to
conclude that there was a significant exposure to infectious agents or any release of BSATs outside of the
secondary containment barriers of the facility. in addition, the mechanical problem that caused the transient
airflow reversal has been corrected and veri?ed to function properly.

APPENDICIES

Appendix 1 Data supplied bv CDC during inspection upon request by DSAT

 

 

Vivariu Dec 113 i3
Copy. 

Appendix 2. Data supplied by aaboratorvr during inspection upon request by DSAT

 

Reerece
Document. 

Accession Number: Special91714 Page: 97 Sean Date: 2014-09?17 COPY

 

(cocioeHanosm)

 

       

 

 

From: 

Sent: .D, 2012 6:31 PM

To: I I 

Cc: LJ.S.C.  
Subject: FW: Airflow in {3542 I

 

(bli?l

 

ponse} that I sent to ?33334  (and copied ARE personnel] on the dal,r of our last

. id not send me any more information but I guess he has been in contact with it?

and other ARB personnel. I also read the memo from 13 33 - . ?lot know who in DSAT she is
referring to, however I am sure she would tell you if you asked. Does the have any information? I will
be back in the office on Friday, but until then, I will answer emails when I can.

 
  

 

 

 

 

 
      
 

[We (CDCIOCOOJOSHE)
bruary 16, 2012 4:16 PM
To ?mac 
Cc: Powell, Nathaniel (cocrotonlcazmrl? i if  lrcocrommcezm); Williams, Allison
(cocxotorncezmji imam
Subject: Re: Airflow in adage-5,?

 

 

 

 

 

32-142 . . .
Thanks uses we will look into it.

 

mum?s?u-



- A. uary16,2012 04:13 PM
 
momcezmyl?ii?ii Williams, Allison

Fro
5e
To:
Cc: Powell, Nathaniel 
(Cocroiorucezm) 
Subject: Air?ow in 

   
 

 

 

  

 

It i
Good afternoonl et al

 

 

 

 

This morning I was a part of an escorted group that walked through of the clean areas in the Vivarium of Bldg. and
wanted to make you all aware of a circumstance that the group encountered.

 

in the clean corridor, the ARB technician inside opened the door to the
- ble puff of air could be felt coming through the slit in the window out
2 that this room does not house infected animals at the present time.

I  I

  

animal room. As the door closed a ver 
into the ?clean? corridor. I was told by  

 

 

[p.153

 

 

 



1

Accession Number: Specia191714 Page: 99 'Soan Date: 2014?09?17 COPY

 

(?lial.

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers fo Disease Control and Prevention
1600 Clifton Rd. NE MS A46
WES



 

 

 

Vision: To be the preeminent resource for safety and security of biological agents and toxins.

2
Accession NUmber: Specia191714 _Page: 100 Scan Date: 2014-09?17 COPY

 

 

 

Vvarium 

[11:13:42 U.S.C. 2523M:

 

 

 

 

 

Accession Number: Specia191714 Page: 101 Sean Date: 2014-09-17 COPY

 

U30. 262mm

 

 

Verification

 

 

[Elli-:42 USE. 252mm

 

 

 

The Federal Select Agent Program Policy is based on the above BMBL Standards
as currently gublished and is subject to change. Current policy:

[b36342 U30. 262mm

 

 

 

Accession Number: Specia191714 Page: 102 Sean Date: 2014-09?17 COPY

 

 

[5:831:42 USE. 252%:

 

 

 

Accession Number: Specia191714 Page: 103 Scan Date: 2014-09-17 COPY

 

[b::[3:2242 U30. 252mm

 

 

 

Accession Number: Specia191714 Page: 104 Sean Date: 2014-09?17 COPY

 

inj:.:3j::42 use. 252mm

 

 

 

If there are any questions about this policy} please contact the CDC DSAT Facility
Ior the 

(bll?l

 

 

 

 

Facility Specialist

 

Accession Number: Special91714 Page: 105 Sean Date: 2014-09?17 COPY

 

 

 

 

 

(allele -
2525mm   .. 
Subject: FW: Thank you
(we 1 .. 
(CDCIOIDJNCEZID)
I: rsdav. Februarv 23, 2012 3:23 PM
i Holt James D, (CDCJOCOOI

  

 

 

 

 

 

 

 

 

 

 

 

   

 

 

 

 

 

 

 

 

 

cm; 
i=1  CDC Ireaehlsalagaggv [we - -
I - we? WEI  
tom-MUS? 
(CDCrocooxos - We? 
3 Corroeepwosm; are: whirl-BI: CDC 3- -
seamen); 23W roses); [bi-t6: - - 
    I j:  . lens: . 
i  Allison Powell, Nathaniel (coClolomCEZID)
m2  - Weyant, Rob 
Sig-m  [be (CDCJOPHPRIDSAT)

 

Subject: RE: Thank you

.C. 
 

 

 

. [bli?i

  
   
   

 

 

 

 

 

 

 

 

 

 

 

 

 

Biologistlr Animal Resources Branch
ging and Zoonotic-lnfectious Diseases

Pant-pr Fn?m

 

 

 

 

. You have my complete support.

 
 

  

 

 

 

 

 

:42 use. 

(bii3i

 

 

  
 

 

 

 

 

U. 
 I no?

 

  



 

   

 
  
 
 
   
    
   
    
  

 

 

(CDCIOPHPRIDSAT)
hruary 23, 2012 3:20 PM
I all (CDCIOPHPRIDSA

   

 

 

 

 

 

 

 

 

- Holt James D. 
- (CDCIOPHPR a -
(coClcP
Wags; mils-?-
 -- limits: - 

   
   



 
 
   
 


CDC OPHPR 

 

 

 

 

 

 

   
  

 

   

  

  

    

 

 

 

.(Coclomlr W133i? m? -

@5311? (Epsteeseelo?f (CDcrocoolo HE (CDCIOPHPRIDSAT - ?i   

2W CDC we:   
tale? - their 
lblEsl CDCIOPHPRIDSAT) lollbl tee:- (CDCIOPHPRIDSAT. 7-  
Williams Allison Powell, Nathaniel II (CDClOPHPl-tlosm) (CTR),

IWII CDC OPHPRIDSAT)

Kaila? . wits: Weyant, Rob 
(coczoeHPl-tlosm) 

 

Subject: Thank lyou

On behalf of the Associate Director for Science (ADS) at DSAT We want to thank you for your
participation and commitment to the Biological Select Agents and Toxins (BSAT) Interagency
Inspector Training (IIT) Program. The success of this training program is attributed to your insightful
presentations, enthusiastic discussions, and logistical support.

1

Accession Number: Specia1917l4 Page: 106 Sean Date: 2014-09-17 COPY

Once again. we deeply appreciate all of you for taking the time to participate in the program. We hope
tocountonyoursupponinthefuuwe

 

 ibii6i I
Training and Outreach Coordinator
Division of Select Agents and Toxins
Office of Public Health Preparedness and Fiesponse
Centers for Disease Control and Prevention

1600 Clifton Fload, NE A-46
?ltganta. GA 30333

 

 



 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

Please consider the environment before printing this e-maii. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected, privileged. or confidential. and it should not be disseminated, distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination. distribution, or
copying is strictly prohibited. if you think you have received this document in error. please notify the sender immediately and destroy the

original. Thank you.

2
Accession Number: Specia1917l4 Page: 107 Sean Date: 2014-09-17 COPY

 



      
   
     

 

 

 

From: tcocroeupsxosm}

Sent: Frida Aril 20 2012 4:56 PM

To: [0133242 USC. 252301} 

Cc; '0 'Frazier
Rodrick I ?33:33-14? U-S-C- i 2523f?:
i tcocross - - - -



Subject: RE: CDC Respo to DSAT Request of April 13. 2012 RE: Incidents During Visitor Tours
of the Buildin Vivarium

 this email acknowledges receipt of said responses.

 

 

 

Best regard,

 

tb]t3]:42 use. 262ath)

 

 

DSAT

 

E2251

[bli??

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop 

Atlanta, GA 30333

1:42 0 so. 

Visum: Tu he the preeminent rtts'?ttri?f?'?tt' the safety rind secui'irv of'hiuiogicui agents and toxins.

This document is intended for the exclusive use of the recipientts)I named above. it may contain sensitive intonnation that is protected. privtteged. or confidentiat,
and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. it you are not the intended recipientts}. any
dissemination. distribution. or copying is sirictty prohibited. it you thinit you have received this document in error. ptease notity the sender immediateiy and destroy
the originst. Thank you.

 

 

 



I20, 2012 4:Sent: _Frida Apri

To [003,42 U.S.C. 

 
    
 



  
 

        

       

   



 
 

1' 

 

 

 


Subject: CDC Response to DSAT Request 0

 

{b
prril 13, 2012 RE: Incidents During Visitor Tours of the Building Vivarium

I I
Good Afternoon

Per your e-mail and attached letter of April 13, 2012, please find attached the CDC response to y0ur request for me to
provide additional information regarding incidents that occurred in the Building Vivarium during tours on February 1411
and February 16, 2012.

over Letter-FlNALa04202012.pdf ss
FlNAL.docx 

cc File: CDC Response to DSAT Request Date 04132012

1
Acce531on Number: Specia191714 Page: 109 Scan Date: 2014-09-17 COPY

[bjf33142 USE. 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

[13131242 USE. 2528Eh}

 

 

 

 

Accession Number: Specia191714 Pa?ge: 110 Scan Date: 2014-09?17 COPY

 



 

 



    
  
 
  
     

   
 
 
 

 

 

 

 

 

From: N: icocroeHPRiosm)

Sent: nesd May 02, 2012 5:08 PM

To: UM

Cc: with mine  

tithe.-. imam   

  tcocroenpexosm);  
tcocroeHPRrosnti

Subject: RE: Requested Documentation

 

Thanks once again for your valuable assistance and leadership in identifying key partners in collecting this beneficial
information. We look forward to your continued support toward the completion of this significant project. Also, a
priceless thank you to the men and women whom we have interviewed thus far, as well as those waiting to be
interviewed.

Most a ppreciative,
tbjtajzaiz so 26251th

 

 

 

DSAT

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop A-46

Atlanta. GA 30333
r,in iz42 uso. I

202 (hi 

lit-ion: To be the resource for the and .vet-urity nfhini?ngit-ni agents and toxins.

This doCument is intended for the exciusive use of the recipientts) named above. it may contain sensitive information that is protected. priviteged, or contidenhoi.
and it shouid not be disseminated, distributed. or copied to poisons not authorized to receive such information. if you are not the intended any
dissemination. diSiribution, or copying is strictiy prohibited. if you thinit you have received this document in error. piease notify the sender immediately and destroy
the enginai. Thank you.

  
 
 

 

WW .. 
Sent: Wednesday, May 02, 2012 3:13 PM
M3 II:  I
 
252m?? s.
- 3- 3- E. 
Subject: Requested DoCUmentation

 
  

 

 
  
  
 

 

 



       
 

 

 

 

 

(b i:42u.s.o.?
262 in) 




 

 

 

Per your request of April 26, 2012, the following documentation is provided with this submission:

1
Accession Number: Specia191714 Page: 111 Sean Date: 2014-09-17 COPY

was last tested for proper airflow by BFO was December 21, 2011. OSHE

 

1} The date when this lab fbj:[3j::4

verified proper airflow on Januari,f 9, 2012.
2) Any documentation of the first two 'pdf? attachments are provided by the third 'pdf? is the OSHE

verification of airflow on January 9, 2012

 

(bl
File: Vivarium Dec ll?pdf 0: File: Vivarium Dec 11pdf File: Vivarium JAN2012.pdf>>
3] The date when the lab was decontaminated prior to the reported airflow deviation (December 5, 2011 using

Spor-Klenz). The OSHE procedures for Spor-Klenz decontamination are provided below.

 

 

 

cc: File: LABORATORY SURFACE DECONTAMINATION OF WITH 

The specific entrv requirements for the Suites when the labs are hot and cold as well as for the clean corridor

areas outside of the lab suites will be forwarded under separate cover later this afternoon.

 

Best reeards,
ibj:[3 :42 
2525 hi

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road1 NE. Mail Stop A-22

Atlanta, GA 30333
I42 
252 ihj: 

 

 

 

 

2
Accession Number: Specia191714 Page: 112 Sean Date: 2014-09?17 COPY

2E

 

 

 

 

 

 

31.1412 
  
From: - 
Sent: Thursda Ma 03, 2012 8:29 AM
To: . (cocrosusnsmol
Subject: RE: Today's Schedule


 

 

Thanks U-S-C- 

 

 

(mist-am use. 262ath

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop A-46

Atlanta, GA 30333
?busy-42 use. 262ath I

 

DEA i? H's-inn; 'i'rJ he the preeminent i'esntut?uilat' the .sttii?tjl' surrurt'ty {tl?ttii?? mid it'ixinrc

This depulnent is intended tor the ex ctu5tve use oi the recipientisj named above. it may contain sensitive information that is protected. or confidential.
and it shoutd not he disseminated distributed or copied to persons not authorized to receive such inierrnation. it you are not the intended recipientts}. any
dissemination, distribution. or copying is prohibited if you think you have received this document in error. please notify the sender immediately and destroy

the original. Thank yclu

 

 

From. use. ?alhjalbus; I
I

Sent: Thursday, May 03, 2012 ?:28 AM




Hows: 

.  :52. (cociotomcezm);
Powell, Nathaniel 
Subject: Today's Schedule

  
  
 

 

 

 

 

[01331142 USO. 2623th I

use. a esealh:

CDC OCOOIOSHE) ?3133*??305252?? CDC must-1203.05
 coctomincezmy? coci01oinc1no);

Probst, Paul E. Bowen, Ken L. (CDCIOCOOIBFQ



 

 

    

 

 

 

 

lbj:l;3jl:42 use. 

u-l- .-

To confirm for today, the remaining interviews will be at 9:00 am. and 9:30 am. respectively in Building 20, Fioonn 2111

[same location as yesterdav afternoon).

At 10:0 {ba?g??Dn Powell will be available along with other individuals as per your request to conduct smoke testing in

the Bldiuse. 262

 

Vivarium.

 

 

 

Sincerely,
use. a 2732mm

 

 

 

 

Centers for Disease Control and Prevention

1
Acc9551on Number: Specia191714 Page: 113 Scan Date: 2014-09?17 COPY

Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mair Stop 11-22

[b16342 U30. 262mm

 

 

 

Accession Number: Specia191714 Page: 114 Sean Date: 2014?09?17 COPY

 

 

(CDCIOPHPRIDSAT)

From: 

Sent: Monda til 30. 2012 5:15 PM

To: W53 

Cc: CW gbig'a?ju's'c'


Subject: RE: Interviews

0k.

 

 

 

 

 

 

 

 

 

 

 

 

.  - cocroPHPR/osm
Sent: Monda April 30, 2012 4:41 PM
fl'o:. - CDC 
lBll?lea: (cocroeuesaossn;  

Subiect: RE: Interviews

  

 

 

 

 

 

 

 

Let?s meet about 0915 tomorrow to discuss these interviews

 

lb '15]

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

b] Gpnroia 

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

 

 

 

 

 

 

 

 

..  

Monda A ril 30, 2012 4:38 PM

(cocrompraosm)

 -- . 

 

 

 

Subject: RE: Interviews

 

Thank you for your devoted appreciation and attention to putting together the interview schedules and related activities
as denoted below. This email acknowledges receipt of said noticefdocument and our gratitude for your support. Again,
thank you.

 

1
Accession Number: Specia191714 Page: 115 Scan-Date: 2014?09?17 COPY

 

 

 
 
  

ear;  
Sent: Manda April 30, 2012 3:48 
(bi Sim: 

 

 
  

 

(CDCIOPH 

 

DSAT)

 

 

sum-??  Interviews

 

{bli?l
Good Afternoon

 

 

 

Please see below for the interview schedule for this week?s interviews.

ibii?i
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:00 am. Individual: Dr. Nathaniel Powell
Tuesdag: May 1 Location: Building 24, Room 11-101A Time: 10:30 am. Individual: 
ibli?i

 

 

May 1 Location: Building 24, Room 11-101A Time: 11:00 am. Individual:

 

 

 

Tuesday, May 1 Location: Building 24, Room 11-101A Time: 11:30 am. Individual:

 

?bi'?i?is currently on leave ofabsence through June 2012 and has specifically and personally conveyed to her
line management in DSR that she does not wish to discuss matters related to the Building facility with anyone.

 

 

   

 

 

 

 

 

 


I Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:00 pm. Individual 
$553. I mire:
 may 2 Location: Building 20, Room 2111 Time: 1:30 p.m. Individual 
03:03
Thursday, May 3 Location: To Be Provided Time: 9:00 a.m. ndividual:
Thursday, May 3 Location: To Be Provided Time: 9:30 a.m.lndividual:

 

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of ARB, OSHE,
BFO and theoffice will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 

[mi 3:42 uses
252 am:  

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop 

Atlanta. GA 30333

U.S.C. 2625ilh',?

 

 

 

 

2
Accession Number: Specia191714 Page: 116 Sean Date: 2014?09?17 COPY

(CDCIOPH PRIDSAT)

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



{bhl?a?nd?u ?nril 1! i 2012 5:18 PM 
i" 1' 
it'll? 
Subject: Re: Interviews
0k.

From: 
Se a pril 30, 2012 04:40 PM
(233%? 
c: 
Subject: RE: Interviews

 

 

 

Let?s meet about 0915 tomorrow to discuss these interviews

 

lb '15]

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

?l-Inni-n Phl?l'?ll? Ina}:

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
  

3: . o.

?g?a?mm  
Sent 30, 2012 4:38 PM 
To:   (cocrosemsepem; (CDCIOPHPRIDSAT) 

lethal:  
Subject: RE: Interviews

335

Thank you for your devoted appreciation and attention to putting together the interview schedules and
related activities as denoted below. This email acknowledges receipt of said noticefdocument and our
gratitude for your support. Again, thank you.

Best regard,

 

(bill 

 

 

 

1
Accession Number; Special91714 Page: 117 Sean Date: 2014-09?17 COPY

 

  

 

  

    
n-  - 
ll 3- a. [bit (has; JOPHPRIDSAT)

 

 

 

 

(CDCIOPHPRIDSAT)

 



 

I?b 3 2 US 
?g?allguoc??ftemoon 

 

 

 

Please see below for the interview schedule for this week?s interviews.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ifb?lf?';
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:00 am. Individual: Dr. Nathaniel 
Powell 
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:30 am. Individual:
03103} 
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 11:00 am. Individual:
[busy-a. 
Location: Building 24, Room 11-101A Time: 11:30 am. Individual:
[bit I
?ah-5:1 is currently on leave of absence through June 2012 and has specifically and personally i 

 



  

cooveyed to her line management in DSR that she does not wish to discuss matters related to the Buildi
facility with anyone.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

use. 
Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:00 pm. Individual: ?252803?
 
(use,
my Wednesd y, May 2 Location: Building 20, Room 2111 Time: 1:30 pm. Individual

Thursday, May 3 Location: To Be Provided Time: 9:00 am. Individual:
Thursday, May 3 Location: To Be Provided Time: 9:30 am. Individual:

 

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of
ARB, OSH E, BFO and the office will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

[bii3 ?42 
262:  

 

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

2
Accession NUmber: Specia191714 Page: 118 Sean Date: 2014-09?17 COPY

Atlanta, GA 30333

2 2am: 

 

 

 

 

3
Accession Number: Specia191714 Page: 119 Sean Date: 2014-09?17 COPY

  

Subject:

 

[3:13:42 
a 52301:: 

 

 

 

Thank you for your devoted appreciation and attention to putting together the interview schedules and related activities

(CDCIOPHPRIDSAT)

use.

I 

  
 
 

 


RE: Interviews

 


o, 2012 4:33 PM
031(6)


 




 

 

 

 

 



essays}. .

 

 

as denoted below. This email acknowledges receipt of said noticefdocument and our gratitude for your support. Again,
thank you. 

Best regard,

 

mils :42 uses
2623 h: 

 

 

 

 

   

Fron1:

[0023:1242 U.S.C. 252301}



 

Sent: Monda April 30, 2012 3:48 PM
FEW a? 5 Ilblli?l IcociOPHPiuosnT)

I . 
Tu' 

 

 

Cc: libli?l 
Subje nervlews

(bli3lz42 use. 

252510o'odinfternoon? 





 

(cocropupaxosnr)

 

 

 

 

 

 

Please see below for the interview schedule for this week?s interviews.

Tuesday, May 1 Location: Building 24, Room 11-1019.

 

Tuesday, May 1 Location: Building 24, Room 11-101A

Tuesday, May 1 Location: Building 24, Room 11-1019.



Tuesday, May 1 Location: Building 24, Room 11-101A

.IJHE . .
is currently on leave of absence through June 2012 and has specifically and personally conveyed to her
line management in DSR that she does not wish to discuss matters related to the Building facility with anyone.

WI:aner

1y, May 2 Location: Building 20, Room 2111

 

uses
252mm

 

 

 

Wednesda May 2

Thursday, May 3
Thursday, May 3

Location: Building 20, Room 2111

Location: To Be Provided
Location: To Be Provided

Individual: Dr. Nathaniel Powell

use. 

 

Time: 10:00 am.

Time: 10:30 am. Individual ?13153
Time: 11:00 a.m. Individual
Time: 11:30 am. Individual

 

 

Time: 1:00 p.m. Individual:

 

 

Time: 1:30 p.m. Individual:

 

 

 

Time: 9:00 a.m. ndividua 
Time: 9:30 a.m.lndividua_ 

 

[till I

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of ARB, DSHE,
BFO and the RO's office will be available to assist.

Accession Number:

Specia191714

Page:

1

120 Sean Date:

2014-09-17

 

COPY

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

[13:13:42 U.S.C. 252%:

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[boil-:42 USE. 252mm

 

 

 

 

2
Accession Number: Specia191714 Page: 121 Sean Date: 2014-09-17 COPY

 

 

 

 

 

 

 

 

 

   
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2b ?3142 USC. 
a? 

(pirate use.
From: 25261th icocxoeHPwosen
Sent: Wednesday, April 25, 2012 9:26 AM
To: ?em USC- 252%?? 
Cc: sem- Frazier,
Rodrick 
33,32? 33:31:? U-e-u- 
a? 3
Subject: RE: Meeting for April 25. 2012
ibj'33142 

 

 

 

26 am: ?t at all

 

Thanks for rearranging your schedules to meet with us to clarify and discuss a few points of interest in going forward in
resolving this investigation. We look forward to what we believe will be an instructive and useful discussion.

Please note, due to a prior engagement and a conflict in my schedule with another scheduled event, it is unfortunate
that I will not be in attendance, but knowing that DSAT finest will be there -- I have confidence it will be a great meeting.

Again, thanks for honoring our request on such a short notice.

 

 
(3]:42 USE. ll
262ath 

Form 3 Site Visit Coordinator



 

 

 

3142 use. 
aezerhi

 

 

 

 

 

Preparedness and Response Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A46
anaat

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientis) named above. it may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientts}, any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.



Sert: Wednesday, April 25, 2012 118 AM
To. ??3342 U-S-C- 
- (cocxosmsitseppd Rodrick 
user-3:242 U-s-c- 262m 
Subject: RE: Meeting for April 25, 2012

 

 

 
 
  

 

 

 

 

 

 

(bliilz42 use. 
262:  

 

 

 

1
Accession Number: Specia191714 Page: 122 Sean Date: 2014-09?17 COPY

We have Room Bl 13 in Building 20 already reserved for a meeting at 1:30, so we'll just slide that meeting back to 2:15
and ask that we meet with DSAT in Building 20, 0113 at 1:30 if that will work with you. Several of the individuals that
were to be in attendance for the original 1:30 meeting we had the room reserved for will need to attend your meeting
anyway, so this will work well.

Many thanks in advance for your consideration of this request.

Best regards,
inii uses
262aih:

 

 

 

 

Centers for Disease Control and Prevention Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22
Atlanta. GA 30122

ib}[3 :42 
2522 h: 

 

 

 

 

inal Messa 
Ecocxoedpnxosm)
Sent: Tuesday, April 24, 2012 3:14 PM

 
  
   

 

  

 

 

ggiggiaF-s  (cocrosesrisppeoi
- . hard ilicocxoscLsi'LSPePo); Frazier. 
.cocxoaHenr-osa-T} egg? 9 

 

 

 

 

 

 

(CDCIOPHPRIDSAT)
Subject: Re: Meeting for April 25, 2012

 

.
Thanks v.50. 2 for your thoughtful consideration to our request. I will inform you of the spemfic details on tomorrow as

soon as they become known. Your gratitude and partnership in this endeavor is appreciated. Goodnight for now!

[5552]

 Original Message 

icociosusiLsepeoi

 
  

 

Se - - pril 24, 2012 05:20 PM
.80. 
giggiin  
Cc: Frazier, Rodrick 

Subject: Re: Meeting for April 25, 2012 .

(in 3M2 usog
262ath 

 

 

 

 

Where would you like to meet?
Best regards,

252m

 

 

 

 

 

I 5' 

gagaciprom.   
sent: Tuesday, April 24, 2012 04:03 PM

(?midi-13 05  

252aihj; 

2
Accession Number: Specia191714 Page: 123 Sean Date: 2014-09-17 COPY

 

use.
c:   (CDCXOPHPRIDSAT) ?523th 
Subject: Meeting for April 25, 2012

 

ibii?i

 

 

 

 

 

 

 

us. 
252m .. 
hDear

 

 

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
ofthe Building i i?arium Tours. Again, mv apology for the short notice, and thank vou in advance for your support
and considerationis) to requests.

 

PS: I am not in the office at this writing, this message is being sent via my BlackBerrv. Feel free to respond at your
earliest convenience, Most 

Resoectfullv,
(3]:42 use. 
2323mm 

 



 

 

 

3
Accession Number: Specia191714 Page: 124 Sean Date: 2014-09?17 COPY

(bit
252

 

(CDCIOPHPFUDSAT)

 

 

 

ibji3):42 use. 
2626mm 

Wednesday, April 25. 2012 9:33 AM
?333342 Lime


ibii?i

 

 

 

 

 

    
  
 

(pirate

 

 


bji3ji42 USC.

2e2ath)

(CDCX





 

 

 

 

 



 

 

 

 

 

 

Subject: RE: Meeting This Afternoon

 

fbh?

3:42 
2E2 -

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Ijust read your email belowfew others have planned around this time. We will get
back with you as soon as we can. Thanks.

 

lib]
26

]:42 use.


ch]   

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE. Mailstop 

GEL 1011?.


 

(bit
262

 

 

 

USA To he the preeminent resource or the s'tr?tty and securiti? tgi'hiuiogimi agents and 

This document is intended for the exctusive use at the recipientfs) named above it may contain sensitive information that is protected, privileged. or confidentiat.
and it shouid not be disseminated. distributed. or copied to persons not authonzed to receive such information. it you are not the intended recipientst any
dissemination. distribution. or copying is strictty prohibited it you think you have received this document in error. ptease notiiy the sender immediateiy and destroy

the originat. Thank you.

 

 

   

. . .  
2e2aithO.m.- -  

sen t: Wednescl
 

25251E .-  I

ubject: Mean?



v. April 25. 2012 9:22 AM


g.This Afternoon

   



 

 

 

 

 

'15]

 

 

 

Is there any way we can have the meeting in Building 20. 31:13 at 1:00 - 1:45 pm? We've had a request to change the
time due to schedule conflicts for some.

Thank you in advance.

 

[13:32:42 USE.
2B aihj:

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop lift-22

Accession Number: Specia191714 Page: 125 Sean Date: 2014-09?17

262aih-}-- 

usc. 

COPY

 

3):42 use. 5;

2o ?aihj  

 

 

 

 

 

  
      

 

 

 

 

 

 

 

 

 

 

 


From: 
Sent: - .- til 25, 2012 9:58 AM
To: . I 
siege-SD (cocropnearosm)
Subject: Fw: Meeting This Afternoo
All,

informed me to disregard the previous emaii request to change the meeting time, the meeting will remain as
previously scheduled. Thanks.

 

(b](3]i42 use. 262ath

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop 1146

Atlanta, GA 30333
to) 3:42 use. 
26 ?a?hj  ..

 

 

 

 

?irt Vi'sii'in.? 'i'i'i hi! the preeminent resource for the sitter}: unit .seutiriifi: agents and toxins

This document is intended for the exotusiue use of the reoi'pientts} named above it may contain sensitive intonnation that is protected, priviteoed. or confidential,
and it shouid not be disseminated, distributed. or copied to persons not authorized to recewe sucn information it you are not the intended reoipienti?s}. any
dissemination. distribution, or copying is stn?crty prohibited ti you think you have received this document in error, otease notify the sender immediatety and destroy
the originat. Thank you.

 

 

 

 

 
 
     

 
   
    
 

     
 

 

     
  
 

   

ibiiS' 1. 
ZBEaet-om-  sit-5's 
I I Sent: Wednesda April 25, 2012 9:252i.  

 

Subject: RE: Meeting This Afternoon

mustfew others have planned around this time. We Will get
back with you as soon as we can. Thanks.

 

{bj?33142 use. 2525mm

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop ifs-46

1
Accession Number: Specia191714 Page: 126 Sean Date: 2014?09?17 COPY

Atlanta, GA 30333

(th3 :42 use. 
252; h) 

 

 

 

 

 

.0331?" Vision: To he the preeminent i'esoitrt'e?ir the safety ontt' security agents and toxins.

This document is intended for the exctusive use of the recipientts} named above it may contain sensitive information that is protected, privileged, or oontidentiat.
and it shoutd not he disseminated. distn'huted. or copied to persons not authorized to receive such information. it you are not the intended reoipientts}, any
dissernination. distribution, or copying is prohibited tiyou think you have received this docament in error. piease notify the sender immediate-iv and destroy
the originat. Thank you.

 

 


Sent: Wednesday, April 25, 2012 9:22 AM


 

 

 

is there any way we can have the meeting in Building 20, 3113 at 1:00 1:45 pm? We?ve had a request to change the
time due to schedule conflicts for some.

Thank you in advance.

 

03213 42 0.5.05
252a h: 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

mus: l2 uses
252:?. 

 

 

 

 

2
Accession Number: Specia191714 Page: 127 Sean Date: 2014-09?17 COPY

 

 

 

 

 

 

 

 

 

 

 

(b USC. 
26am -- 

From: icocxopHPR/osm)
Sent:  da Aril 25, 2012 10:19 AM
To: (3?61 icocxoerazosm
Cc; m1 (W 
Subject: FW: Meeting for April 25. 2012
will 

 

 

 

Please see the following email messages below regarding a scheduled meeting with the Centers 3 i" i?

  

and staff) today

at 1:30m to discuss the incident that occurred on February 14th 16th, 2012. This email is being sent per request




a warm.

 

(03:33:42 0.30. 26251th

 

 

 

Preparedness and 
1600 Clifton Rd. NE.
Atlanta, GA 30333

esponse Centers for Disease Control and Prevention
Mailstop 

 

(013F142 use. 

 

25m.  

and secority of biological agents and toxins.

IDSAT Vision: To be the preeminent resource for the safety

This document is intended for the exclusive use of the recipientls} named above. it may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. if you are not the intended recipient{5], any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

[01:23:42 US. .

 
 

 

262an?rom, . [01:33:42 10:13:24(but?  .
{coo

Subject: RE: Meetin

<0

y, April 25, 2012 7:18 AM


ma: (b
2

for April 25, 2012

 

Tots) 

 



95142 3
02am)

PRIDSAT)

 

We have Room 0113 in Building 20 already reserved for a meeting at 1:30, so we?ll just slide that meeting back to 2:15
and ask that we meet with DSAT in Building 20, 8113 at 1:30 if that will work with you. Several ofthe individuals that
were to be in attendance for the original 1:30 meeting we had the room reserved for will need to attend your meeting

anyway, so this will
Many thanks in adv

Rest rewardsl
(one; 42 uses
2023 hj: 

 

 

 

 

work well.

ance for your consideration of this request.

1
Accession Number: Specia191714 Page: 128 Sean Date: 2014-09?17 COPY

 

WEEK-12 
262 [hi2

 

 

 

Centers for Disease Control and Prevention Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22
Atlanta, GA 30333

?42 
262 am}

 

 

 

 

     
 

   

[bil3ii



3 i= Frazier. Rodrick 
W6 (biiai-42usc . .
-eoc--o-paea.o.. as, 262a,, - - - 
?6 5 (CDCIOP new) ,i cociorarnrosm 

are" {cocx PHPRIDSAT)
Subject: Re: Meeting for April 25, 2012

 

 

 

 

 

 

 

 



2B2aihThank-s- for your thoughtful consideration to our request. I will inform you of the specific details on tomorrow as
soon as they become known. Your gratitude and partnership in this endeavor is appreciated. Goodnight for now!

 

 

 

 

 

 

 

 

 

 

ibiis 42 use 9
252a h) 
inalMessa 
$55112  
?g ipril 24, 2012 06:20 PM
ibiisi: er; g,
252aiiljo  
(bitalcc  icocropnpiirosml; Frazier, Rodrick 

 

Subject: Re: Meeting for April 25, 2012

Where would you like to meet?

 

 Oriinal Messae 
lessee:  
Sent: Tuesda ,Aril 24, 2012 04:03 pM

I  

Suhject: Meeting for April 25, 2012

 
    
 

 
  
 

 

 

2' (cocropHPR/osm}

 

u. o.
252th E5117.

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident

2
Accession Number: Specia191714 Page: 129 Sean Date: 2014-09?17 COPY

  

of the Building F3i; Virvariurn Tours. Again, my apology for the short notice, and thank you in advance for your support

and consideration(s} to DSAT's requests.

PS: I am not in the office at this writing, this message is being sent via my BlackBerrv. Feel free to respond at your
earliest convenience. Most 

Respectfully,
(maize use 
2622 

 

 

 

 

3
Accession Number: Specia191714 Page: 130 Sean Date: 2014-09?17 COPY



From: 

 

Sent: Wednesda ,Aril 25. 2012 3:5? AM

  

Tn: 
Subject: Accepted: Meeting with DSAT

1
Accession Number: Specia191714 Page: 131 Sean Date: 2014-09?17 COPY

 

 

 

 

 

      

   

 

 

 

 

 

(c DCIOPH 
From: 
Sent: Tuesday. April 24, 2012 3:(?lls? (cocxo HPR 

Subject: Re: Meeting for April 25, 2012
s? 3 3?3 1? for your thoughtful consideration to our request. I will inform you of the Specific details on tomorrow as

 

soon as they become known. Your gratitude and partnership in this endeavor is appreciated. Goodnight for now!

 

  
  




Sent: Tuesday, April 24, 2012 06:20 PM

- -   

Frazier, Rodrick 
Subject: Re: Meeting for April 25, 2012

 

 

?Where would you like to meet?

Best regards,
U505

 

 

 

 

 Oriinal Message 

  

 

 

 


Se 24, 2012 04:03 PM
Adi-ii: Firms?  
We? 

 

 

 

Subject: Meeting for April 25, 2012

 

?3:13:14 
 

 

 

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
of the Building Virvarium Tours. Again, my apology for the short notice, and thank you in advance for your support
and considerationis) to DSAT's requests.

PS: lam not in the office at this writing, this message is being sent via my BlackBerry. Feel free to respond at your
earliest convenience. Most 

 

Resoectf lly,
(by, 
262  

 

 

 

1
Accession Number: Specia191714 Page: 132 Sean Date: 2014?09?17

 

will?? :42 
25251 h] 

 

 


From: 

 

  
 

 

 

 

 

Sent: Tuesda Aril 24, 2012 4:03 PM
To: ?Jr-3342 5 2523 3 42 
cc; 
Subject: Meeting for April 25, 2012

scribe? 3

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at

I 1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident

Virvarium Tours. Again, my apology for the short notice, and thank you in advance for your support
and considerationls) to requests.

PS: lam not in the office at this writing, this message is being sent via my BlackBerry. Feel free to respond at your
earliest convenience. Most 

Respectfully,

(by )z42 use. 
262  

 

 

 

 

1
Accession Number: Special91714 Page: 133 Sean Date: 2014-09?17 COPY

(CDCIOPHPRIDSAT)

   

 

I 
From: 
Sent: Tuesda Aril 24. 2012 3:16 PM
To:  
Cc:  
Subject: Re: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours

of the Building Vivarium

Clkav,l will try to make contact ASAP. The enoted in vour email assome 

present, I am at the Motor Vehicle Office awaiting my term to be seen. Note that I will get right on it shortlv hereafter.
Thanks.

 

 

 

- -- - 

Se --. pril 24, 2012 02:51 PM
gill?   
Subject: FW: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours of the Building 
Vivarium

  

(more, Bog
262a?W   

 

to set up a meeting tomorrow around 1:30 to discuss this incident?

 

if she says yes please let marv know

 

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Jlittlanta. Georeia 30333

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

 

  

 

 

 

   

 

 

 

 

 

 

 

- Em 

- ri 20,2012 4:20 PM

W6

ling. -.  ..  

gasses: miss:  
1

Accession Number: Specia191714 Page: 134 Sean Date: 2014?09?17 COPY

 

[him-:42 
252301: 


Subject: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours of the Building Vivarium
Good Afternoon ?33533542 U-S-C- 

Per your e-mail and attached letter of April 13, 2012, please find attached the CDC response to your request
for me to provide additional information regarding incidents that occurred in the 

tours on February 14 and February 16,2012.
Cover Letter-FlMAL-04202012.pdf? Response to DSAT Request Date 04132012 

Respectfully submitted,

 

[Elli-12 U.S.C. ?202all13

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus

1600 Clifton Road, NE. Mail Stop A-22
Atlanta. GA 30333

[003242 U.S.C. 252mb:

 

 

 

 

2
Accession Number: Specia191714 Page: 135 Sean Date: 2014?09?17 COPY

 

 

 

 

Kati/Emmet)

 


From: lbll?l 
Sent: Friday, April 20: 2012 4:59 PM
To: (bile) CDCXOPHPRIDSAT)
:42
Cc: (bile) 
Subject: FW: CDC Resp - to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours

[13:

Vivarium

 

FYI

Thanke
(b16142 use. 26251th

 

 

 

 

Office of Public Health Preparedness and ReSponse
Centers for Disease Control and Prevention
1500 Clifton Rd. NE, Mailstop tit-45
.GA 30333
(W - 

262 tin  

Uni-1T Vision: to lie tire preeminent tire safety nno? seem-in: nt'liloi?ngn?tti agents and toxins.

This document is intended for the exclusive use of the named above lt may contain sensitive information that is protected, privileged or confidential.
and it should not be disseminated, distributed. or copied to persons not authorized to receive Such information. ll you are not the intended reoipienlrs}. any
dissemination distribution, or copying is strictly prohibited. it you ?1an you have received this document in error: please notity the sender immediately and destroy
the original. Thank you

 

 

[0131242 USE. 2523th

    
     

  
   

 

 

 

 

telegrams. 

Sent: Frida Aril 201r 2012 4:20 PM
10131?? We] 
Wil?l I (cocromperosnr -   . i i I 
toils: {bite}  j; I If

 

 

252m -
 
Subject: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours of the Building Vivarium

 

0.8.0. 262a(h]

 

Good Afternoon

 

 

Per vour e-mail and attached letter of April 13, 2012, please find attached the CDC response to your request for me to
provide additional information regarding incidents that occurred in the Building Vivarium during tours on February 14
and February 16, 2012.

Cover CDC Responseto
DSAT Request 

 

Res ectfullv submitted,
the :42 05.05
252m: 

   

1 
Accession Number: Special91714 Page: 136 Sean Date: 2014-09?17 COPY

 

tb:.:3::42 use. 2'62auzhj:

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop Av22

ibj:t3j::42 use. 252mm

 

 

 

I 2
Accession Number: Specia191714 Page: 137 Scan Date: 2014-09-17 COPY

 

 



Sent: Tuesda Aril 2012 2:29 PM
To: gtcworumosw
Cc: .ibtare U-S-G 

Subject: RE: Request for Information

 

Wiil 

 

(bji33242 use. 262ath

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop tit-46

ta.&A 30333
252 {in 

 

 

BSA Vision: To in: the. preeminent i?esnurce?ior the sniety anti security ofnt'rtiogictti agents and toxins.

This document is intended tor the exc'iusive use oi the recipienttsi named above. it may contain sensitive intonnation that is protected. pn?viieged, or confidentiai.
and it shouid not be disseminated, distributed. or copied to persons not authorized to reseive such intonnation. it you are not the intended recipientis}. any
dissemination. distribution, or copying is prohibited. it you think you have received this document in error. piease notify the sender immediateiy and destroy
the originat. Thank you.

 

 


Sent: Tuesda April 2012 1:55 PM

$2213: so 

Eject: Re: Request for Information
Please wait until I get back in touch iater this week. She is acting a little unusual about this.

    

Thanks

 

 


  

I 'l17, 2012 10:Subject: FW: Request for Information

 

 

 

  
 
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Please review the generated responses prepared to be sent to  

her concerns denoted in her email dated Tuesday, April 17, 2012, upon your approval. 0r otherwise, points of
interest. Please make changes as you deem necessary. Thanks.

 

 

 

 


--..

252  

 

 

 

1
Accession Number: Specia191714 Page: 138 Sean Date: 2014-09-17 COPY

a C1: Please provide a contact list with email address and telephone numbers for each of the
individuals that toured the Building-ft Vivarium on February 14, 2012, and February 16, 2012.

 

DSAT Response: Please be advised, the intent of our mission at this stage is to gather the facts from all
reliable saurces that they may be evaluated going forward to help determined the appropriate steps -
and course of action that will lead to a more prudent and practical decision based on the evidence
presented. At this time, it appears circumstantial and speculative to leap forward with contacting the
said individuals involved in the tours of the vivarium before we have had a chance to collect and
analyze the facts, is our opinion. Although we are treating this event as top priority and carefully, we
want to guard against a speedy resolution and a rush to judgment approach.

. [hi
I Q: The subject line in the letter references "incidents" during visitor tours of the Building
Vivarium and the first bullet requests a completed Form 3 with an executive summary of events including a
timeline of what occurred. 'The first paragraph of your letter implies that there was one incident, more
specifically, the noticeable puff of air that was felt coming through the slit in the window out into the clean
corridor. Please clarify if there is more than one incident of concern from the tours of the Building
Vivarium and whether or not more than one Form 3 will be necessary to address multiple incidents.

  
  

t0
inns; 20.s.c.?


lto the
Building . vivarium space. Participants entered the containment area wearing PAPRs and
showered out upon exit?. In the process of your internal investigation and you determined or find -
evidence that perhaps there may have been an equipment failure with any one of the PAPRs worn by
the first group on the then you will have to tell us whether or not this constitute an occupational
exposure OR release of an agent outside the ofthe primary barriers of the area.
Depending on your findings and determination, this may or may not require a separate Form 3 for the
first group of individuals. From a biosafety perspective, we want know for sure until we have evaluated
all the data and information requested.

 

 

 

U. cs

Furthermore, it is our understanding that: "On February 16, 2012 between 8 -11:30 am,
escorted a second group to the vivarium: I?m: 1
Iml'?: The second group was given the option of
touring the clean corridor outside of containment; they chose this option and did not we s.
According to escort [bit-E: l] as the second group stood outside the door of room in the
clean corridor, the ARB technician inside opened the door to the animal room. As this door closed, a
very noticeable puff of air could be felt coming through the slit in the window out into the clean
corridor?.

 

 

0 C1: Please indicate which individuals if any from the tour groups on February 14, 2012 and February
16, 2012 were seen in the CDC Occupational Health Clinic or sought medical follow-up elsewhere as a result
ofthe incident.

DSAT Response: We have not been made aware of any individuals from either the first group or second

group that toured the vivarium on the dates in question having received or sought medical treatment
nor any medical surveillance being initiated.

2
Accession Number: Specia191714 Page: 139 Sean Date: 2014?09?17 COPY

 uses

2?2ath:   

 

hesitate to contact our office.
Respectfully,

The Form 3 Management and Team

we hope this helps to answer your cancerns, if we can be of further assistance, please don?t

 

revere use.
2525mm  

 

 

 

 

(b]i3]:42 use

Office of Public and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop 

 

Atlanta, GA 30333


 

 

262ath 

 

 

DSA Vision: To be the preeminent resource for the so?g; and secwity ofbioiogicoi agents and toxins.

This document is intended for the exclusive use or? the recipientts} named above. it may contain sensitive infon'nation that is protected. pdviieged. or con?dentiai,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. ify'ou are not the intended recipientts). any
dissemination, distribution, or copying is stn'ctiy prohibited. ityou think you have received this document in error, pieasa noti?r the sender immediateiy and destroy
the on?ginai. Thank you.

 

From: Form 3 (CDC)

  
 
   

 

esda Aril 17, 2012 ?:31 AM
(edema-osm-(cocroprrparosm;
 we: 

 

 

Subject: FW: Request for Information

 

 

 

 

 

 

 

(bil?i
 (-cocioPHPeiosm-r--

i= -  
Sent: Tuesday, April 2012 7:31:05 AM Eastern Time (US Canada)
ibii?i 
Cc: Frazier, Rodrick 

Subject: Request for Information

cameras use. 262a

Good Mornin 

In reference to the letter I received on April 13, 2012, "Incidents During Visitor Tours of the Building [3342

Vivarium", I am requesting the following information from DSAT.

that toured the Building r32;

 



 

 



 

Please provide a contact list with e-mail address and telephone numbers for each of the individuals

Eb"

 

Vivarium on February 14, 2012, and February 16, 2012.

r- o- . . 1
The subject line In the letter references Incidents during visitor tours of the 
and the ?rst bullet requests a completed Form 3 with an executive summary of events including a timeline of
what occurred. The ?rst paragraph of your letter implies that there was one incident, more speci?cally, the

3
Accession NUmber: Specia191714 Page: 140 Sean Date: 2014-09?17 COPY

noticeable puff of air that was felt coming through the slit in the window out into clean corridor. Please
clarify ifthere is more than one incident of concern from the tours of the Building (3) Vivarium and whether or
not more than one Form 3 will be necessary to address multiple incidents. '4

0 Please indicate which individuals if any from the tour groups on February 14, 2012 and February 16,
2012 were seen in the CDC Occupational Health Clinic or sought medical follow-up elsewhere as a result of
the incident.

Thank you in advance for your assistance with the information requested above.

Sincerely,

 


2623

:42 
l'Iii 

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus
1Rnn f?li?nn Dam-l Ml: I'M-ail

 

m;
25

 

33:42 
aih:

top Fit-22

 

 

Accession Number:

4
Page: 141 Sean Date: 2014-09-17

COPY

 

(CDCIOPHPRIDSAT)

From: Form 3 (CDC)
Tuesday, A ril 2012 2:31 AM

. I'b E3
SC.   

 

     
 

 

 

 

 

 

To.

Subject: FW: Request forlnformation 
easem-  

 

Sent: Tuesday, April 17, 2012 ?:31:05 AM Eastern Time (US 8: Canada)

To: Form 3 (CDC)

Cc: ibis? (cocroeHPRrosm; Frazier, Rodrick 
Subject: Request for Information

 

 

 

 

 

(more use. a zsaach)
Good Morningl

 

 

{b
In reference to the letter I received on April 13, 2012, ?Incidents During Visitor Tours ofthe Building ivarium?, I am
requesting the following information from DSAT. {3

r- Please provid a contact list with e-mail address and telephone numbers for each of the individuals that toured
the Buildingivarium on February 14, 2012, and February 16, 2012.

The subject line in the letter references "incidents" during visitor tours of the Building ivarium and the first
bullet requests a completed Form 3 with an executive summary of events including a timeline of what occurred.
The first paragraph of your letter implies that there was one incident, more specifically, the noticeable puff of air
that was felt coming through the slit in the window out into clean corridor. Please clarify if there is more
than one incident of concern from the tours of the Building Vivarium and whether or not more than one
Form 3 will be necessary to address multiple incidents.

- Please indicate which individuals if any from the tour groups on February 14, 2012 and February 16, 2012 were
seen in the CDC Occupational Health Clinic or sought medical follow-up elsewhere as a result ofthe incident.

Thank you in advance for your assistance with the information requested above.

Sincerely,
U.S.C. 262aih',?

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[0:131:42 USE. 252301}

 

 

 

 

1
Accession Number: Specia191714 Page: 142 Sean Date: 2014-09-17 COPY

 

 

 

 

 

 

 

 

 

 

 

 

 
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(pirate use. 
'25?th  (CDCIOPHPRIDSAT)

(bji3jz42 use.
s262arm 
Friday, April 13, 2012 4:01 PM
. . I  
- c-ocroe-H-P-Rresneg- 
ibti?it ocroeHPRiDsnT); 
(CDCXO EL Meechan, Paul J, Henderson, Joseph
tcocxocooxoscP); Frazier, Rodrick 
tcoqoeneerosnr}
Subject: RE: Centers TLR Letter (2B2aiFEhank-s "it-3i? for your prompt response. I called the number listed in your reply but It went straight to your voicemail.

Please will suffice and, therefore, give you time to gather the facts as they unfold. Again, thank you and
have a nice 

  

 

(bii3iz42 use. 26251th

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop tit-46

Gill. 111111

3]:42 uso. 
2e arm

 

 

 

 

 

USA Vision: To be the Jr'u'ewrtintuit the safety ttnri security oj'htriirtgit'tti agents and toxins.

This doCurnent is intended for the exotuswe use at the recipientts) named above. it may contain sensitive information that is protected. privileged, or confidentiei,
and it shouid not be disseminated, distributed. or copied to persons not authorized to receive such information if you are not the intended recipientts}. eny
dissemination, distribution, or copying is strictiy prohibited. it you think you have received this dOCument in error. pieese notify the sender immediateiy and destroy
the originei. Thank you.



 

(mist? 
2623i,    
Sent: Friday. Ao'il 13, 2012 3:45 PM
Wis 
Ect- tit?- 

 

 

 

 

 

 

 

 

     
(bji? Meechan, Paul J. 
Henderson, Joseph Frazier, Rodrick 
Subject: Re: Centers TLR Letter (2)

 

 

25caihj 

 

 

 

[bli??

lam currently out of the office for the rest of this afternoon but will be he I - to respond immediately and
collaborativeiy to assist in the investigative process. Piease call me at 

address actions required at this time, otherwise, I will ensure that all items requested in your attachment are addressed-
by April 20, 2012.

I look forward to speaking with you this afternoon.

Since rely,
42 

 

 

 

 

1
Accession Number: Specia191714 Page: 143 Sean Date: 2014-09?17 COPY

 

42 uses
252:: 3   

 

 

 

 

3353):" 

  
 

   
  

 

   

 

 

 

 

 

 

 

rm?" see; . . . . 3' 2012 03:{52:13:42 (CDCIIOPHPRIDSAT)  
2623 ME: 

 

 

 

 

 

Subject: Centers TLR Letter (2)



Please be advised, the letter attachment denoted in this memo will require your immediate a - ion and 80 

in helping us to understand what happen during the visitor?s tours of the Vivarium in Building . 
a TLR Incident and, therefore, subject to an investigation.

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfullv,

 

(Will :42 U811 
2e2e h] 

 

 

 

2
Accession Number: Page: 144 Sean Date: 2014-09-17 COPY

 

 

PRIDSAT)

use. 

    
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

From: 
Sent: IFrida . Aril 13. 2012 3:23 PM
To: - (SKEW U33 M6)
?PBPatht I CDCXOPHPRIDSAT --

(CDCXOPHPFUDSAT) 
Subject: Fw: Centers TLR Letter 
Attachments: Centers TLR Letter i2).doc
Tracking: Recipient Read
[13133242 
252mm 

 

Read: 4/14f2012 1:55 PM

(bjt3);42 LLS 
a 

 

 

262 coctOPHPiuesan
(PMS) 
(DES) 
Read: qilsizelz 3:26 PM

 

 

 

Correction to previous sent email:

The paragraph of the letter should read: 14?" and 161" instead of February 15th and 15'? . Please note this
change on your copy.

Than you,
use. 262ath

 

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop tit-46

Atlanta GA 101%?
(pirate use. 2623mm

 

 

 

 

DAL-1 i" Vision: To be the preeminent resourc?efOr the safety and security agents and toxins.

This document is intended for the exctusive use of the recipientist named above. it may contain sensitive intonnation that is protected, priviteged. or coniidentiat,
and it shoutd not be disseminated, distributed. or copied to persons not authorized to receive Such information. if you are not the intended recipienttsi. any
dissemination. distribution. or copying is stn?ctty pmhihited. it you think you have received this document in error, ptease notify the sender immediateiy and destroy
the on'ginai. Titanic you.

 

U_blt_?  

Sent: Frida

  
    
 


Aril 13,2012 3:03 PM

 

    

 

 

 

 

 

 

 

To: ?33:4 (mm)
i 3i"?   
I DPH 
Subject: Centers TLR Letter (2)

1

Accession Number: Specia191714 Page: 145 Sean Date: 2014-09?17 COPY

Please be advised, the letter attachment denoted in this memo will require your immediate attention and collaboration
in helping us to understand what happen during the visitor? tours of the Vivarium in Building 
a TLR Incident and, therefore, subject to an investigation.

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfully,

 

(to) 3:42 usc. 
25c am) 

 

 

 

2 
Accession Number: Page: 146 Sean Date: 2014-09-17 COPY




 

 

 

 

 

 

 

 

  

 

 

 

 

  

 

  

   

 

 

 

 

:99 "cf
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
is; Centers for Disease Control
?in and Prevention (CDC)
Atlanta GA 30333
rests? ?if;  I 1 3: 2
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop A-22
Atlanta, GA 30333
I U.S.C. 2E2aih] I
{bl
RE: Incidents During Visitor Tours of the BuildinEVivarium
I I on Februarv 14. 2012 between a -11:30 am. DSAT luel'irig-EEQHI  
izbs?i?f use.  
mm? ivarium space. Participants entered the containment
upon exit. On Februarv 16. mm between a -11:30 am  
$6,523? rium-  I .: I
gbgi?ii??   The second group was given the option of touring the clean corridor outside
of containment; they chose this option and did not wear PAPRs. According to escort I as
the second group stood outside the door of roo ?3 in the clean corridor, the tec nician
inside opened the door to the animal room. As this door closed, a very noticeable puff of air could be
felt coming through the slit in the window out into the clean corridor.
An incident report was provided to DSAT from CDC. This report states that rairie dogs were
holding room after an experiment witti 
I I that all persons working in or entering laboratory or animal care areas where activities with 3~ 33 .. - - -  
virus are being conducted should have evidence of satisfactory vaccination. The two groups of visitors to
the vivarium included individuals who had not been vaccinated for  

 

 

 

 

In order to determine whether the visitors on February 15 and 15, 2012 were exposed to a select agent,
please provide the following information by COB on April 20, 2012:

In Please submit a completed Form 3 along with an executive summary {narrative} of events
including timeline of what occurred.

0 Please provide details on which rooms within the containment block were entered by the first
group of visitors.

0 Please provide information on the work activities being performed in all of the vivarium rooms
during the time intervals of the visit.

a What is/are the requirementts} for entry into the containment block?

- Explain the procedure for preventing entry of unvaccinated individuals into areas where
vaccination is required.

1- Please confirm the last time that active work was performed in procedure roo
the tour by the second group.

I Provide details on the animal housing used througrout the ccntainment block and including any

. . . . . ?3:133:42 U30.
animals housed at the time in animal holding roomsaazam;

 

 

 

 

 

Accession Number: Specia191714 Pages 147 Sean Date: 2014-09?17 COPY

(ovate use. 

2525mm 

tb]t3]:42 use. 

4- Previous HVAC verification test results provided to DSAT for the Buildin

   
   

42' vivarium space were
qualitative and lacked room differential pressure trending data. Please provide pressure
trending data for each of the rooms in the viva rium containment block during the time of the
second group?s visit on February 16, 2012.

 

. 
  

 

If vou have questions concerning this correspondence, please contactl

 

 

 

 

 

 

 

eezath) 

 

 

 

the Form 3 mailbox at: form3@cdc.gov
On all correspondences regarding this TLR Investigation, please be sure to include
as well.
Thank you in advance for vour cooperation and collaboration in this critical investigation.
. 
2525mm  
Form 3 Site   .tisit Coordinator
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
I600 Clifton Rd. NE, Mailstop tit-46
Atlanta (1A 1?1'17l
DEA Vt'st'on; To be the preeminent resource for the sofetv and security ofbt'otogtcot agents and toxins.
Wits document ts t'ntendedfor the exctitsive use rectptemt'sj named above. t! may cantata tnformattort that t: protected. or
con?denn'at, and It shoutd not be disseminated, distributed. or (opted to persons not author?ed to receive such information. Kyoto are not the
intended Hewitt-tits), any mssemrnoti'on, or copymg ts Jyoti thinks-on have re?ned document tn error, ptease
nott?t the sender tmmedi'atei'y and destroy the ortgmot. Thank you.
Accession Number: Specia191714 Page: 148 Sean Date: 2014-09?17 COPY

 



to 3:42
From: . 262a 
Sent: Friday, April 13. 2012 3:03 PM
To: ?30 i 2523 

Cc: [bli?i


 

 

 

 

 

 

 

I .ib3i33342U-S-C-? .  (bii?i

--  

?(titgiwu


Subject: Centers TLR Letter 

Attachments: Centers TLR Letter [2}.doc

 

 

 

 

 

 

 

 

 

 

 

 

Tracking: Recipient Read
CDCIOSELSILS PP 
(bile) Read: 4f14!2{i12 1:54 PM

use 


{CDC/opnpwosan Read: 4x13z2o12 3:09 PM
{cocropi?ipwosan

 

 

 

 

 


2623mgo?duafternoon 

 

 

 

tion and collaboration
This event qualifies as

Please be advised, the letter attachment denoted in this memo will require your immediate a I.
in helping us to understand what happen during the visitor's tours of the Vivarium in Building  
a TLR Incident and, therefore, subject to an investigation.

  

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfullv,

 

1
Accession Number: Specia191714 Page: 149 Sean Date: 2014-09?17 COPY

 sti?e;
4i" 

 

 

in
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
is; Centers for Disease Control
eh and Prevention (CDC)
Atlanta GA 30333
April 13, 2012
I -
2528[h_.

 

 for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop A-22
atlanta. GA 30333

U.S.C. 2E2alh)

 

 

 

{bi

RE: Incidents During Visitor Tours of the Building 333 Vivarium

 
  
 

 

.3ej:i33::42 usoe


 

 

 

 

[ojz'3jzc-l2 U30. 252 ihiThe second group was given the option of touring the clean corridor outside

of containment; they chose this option and did not wear PAPRs. According to escort
the second group stood outside the door of room in the clean corridor, the ARB technician
inside opened the door to the animal room. As this door closed, a very noticeable puff of air could be
felt coming through the slit in the window out into the clean corridor.

 

An incident report my? rided to DSAT from CDC. This report states that rairie dogs were
ieii:3::42 

Convalescing in the use. 262 holding room after an experiment with 252W

       

 

In order to determine whether the visitors on Februarv 15 and 16, 2012 were exposed to a select agent,
please provide the following information by COB on April 20, 2012:

in Please submit a completed Form 3 along with an executive summary (narrative) of events
including timeline of what occurred.
in Please provide details on which rooms within the containment block were entered by the first
group of visitors.
a Please provide information on the work activities being performed in all of the vivarium rooms
during the time intervals of the visit.
- What isr?are the requirementis) for entry into the containment block?
- Explain the procedure for preventing entry of unvaccinated individuals into areas where
vaccination is required. 
Please confirm the last time that active work was performed in procedure room  --
the tour by the second group.
- Provide details on the animal housing used throughout the containment block and including any
animals housed at the time in animm holding room  

 

 

 

 

Accession Number: Specia191714 Page: 150 Sean Date: 2014-09-17 COPY

 use. 

262a?hj ..  

(b]t3]:42 use. 
262athj

- Previous HVAC verification test results provided to DSAT for the Building vivarium space were
qualitative and lacked room differential pressure trending data. Please provide pressure
trending data for each of the rooms in the vivarium containment block during the time ofthe
second group?s visit on February 16, 2012.

 

usc. 
 Lina "Eggagmm

 

 

If you have questions concerning this correspondence, please contact
the Form 3 mailbox at: form3@cdc.gov

 

On all correspondences regarding this TLR investigation, please be sure to include
as well.

Thank you in advance for your cooperation and collaboration in this critical investigation.

Ferm 3 Site Visit Coordinator

 

 

use. I

2S2a?hj 

Accession Number:

 

 

 

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A-46

Atlanta. GA 303 33 I

DEA Vision: To be the preeminent resource for the safety and security ofbioingicoi agents and toxins.

This document is intendedfor rite exciton-e use ofthe rec'ipientrs) named native. it may contain senritil'e information that t: protected, priviieged. or
con?dentiai, and it should not be disseminated, distributed, or copied to persons not authorized to recen'e such information. Hyatt are not the
intended any dissemination. distriiautian. or copying is stricity prohibited. Jyoti think you have rec-awed this document in error. picnic
non?r the sender immediateiy and destroy the originoi. Thank you

Specia191714 Page: 151 Sean Date: 2014?09?17 COPY

 

'm

From:

Sent

To:

Cc:

Subject:
Attachments:

Tracking:

 

(CDCIOPHPRIDSAT)

 

gblte?rs?- 

Friday, April 13, 2012 915d AM

lbllal 

(?3342 Us": 5? 
Centers TLR Letter 

Centers TLR Letter {2}.doc

 

 

 

Recipient Read
Readt4114f2012 1:40 PM

  
  

 




 

. Read: 4f13f2012 9:54 AM

Please review the above attachment letter requesting the aforementioned items we would like for the Centers to
provide in our TLR INVESTIGATION. Please feel free to change, modify, or restructure the letter as you please. Note-you
indicated on yesterday that you would like for the letter to go out by today?s date, with a turnaround of 7 days on behalf
of the responder, so your critical evaluation and input is effectively needed. Thanks.

 

lb]
25

3M2 use. 5;
3.3-.) 

 

 

 

Accession Number:

1

Specia191714 Page: 152 Sean Date: 2014-09?17 COPY

sum?t .
?at .1 .b

4b

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
Centers for Disease Control
?in and Prevention (CDC)
Atlanta GA 30333 .

ulntr
+1oi 

April 13,20l2

 

ibj:i3}:42 uses
252mm    

Centers for Disease Control and Prevention
[600 Clifton Road, NE, Mailstop zit-22
Atlanta, GA 30333

rem-:42 use. eszarnj: 

 

 

(bl
RE: Incidents During Visitor Tours of the Buildin4i3li Vivarium

 

 

 

U30.
2B2afhj:

On February 14. 2012 between a 41:30 am, DSAT 

 

 

 

ibiil33242 
 

{bi324 ivarium space. Participants entered the containment area wearing PAPRS and ShowerEd 

 
 

libii?i:

 

 

 

m: -- The second group was given the option of touring the clean corridor outside

of containment; they chose this option and did not wear PAPRs. According to esco as
the second group stood outside the door of room fungi? in the clean corridor, the ARB tec nician
inside opened the door to the animal room. As this door closed, a very noticeable puff of air could be
felt coming through the slit in the window out into the clean corridor.

 

 

 

 

 

An incident report ided to DSAT from CDC. This report states that prairie dogs were 
convalescing in th DIS-Cs holding room after an experiment wit - 

that all persons working in or entering laboratory or animal care areas where activities with 
virus are being conducted should have evidence of satisfactory vaccination. The two groups of visitors to

the vivarium included individuals who had not been vaccinated  

In order to determine whether the visitors on February 15 and 16, 2012 were exposed to a select agent,
please provide the following information by COB on April 20, 2012:

 

 

 

 

 

 

 

Please submit a completed Form 3 along with an executive summary (narrative) of events
including timeline ofwhat occurred.

it Please provide details on which rooms within the containment block were entered by the first
group of visitors.

I: Please provide information on the work activities being performed in all of the vivarium rooms
during the time intervals ofthe visit. 

What isfare the requirementis) for entry into the containment block?

- Explain the procedure for preventing entry of unvaccinated individuals into areas where
vaccination is required.

0 Please confirm the last time that active work was performed in procedure room 33.35.45?
the tour by the second group.

0 Provide details on the animal housing used throughout the containment block and including any

. . . . . U.S.C.
animals housed at the time in animal holding room seseam:

  

prior to

 

 

 

 

Accession Number: Specia191714 Page: 153 Sean Date: 2014?09?17 COPY


I Previous HVAC verification test results provided to DSAT for the Buildin vivarium space were
qualitative and lacked room differential pressure trending data. Please provide pressure
trending data for each of the rooms in the vivarium containment block during the time of the
second group?s visit on FebruaryI 15, 2012.

 

. U30. 2523!,th 
If you have questions concerning this correspondence, please contact via

the Form 3 mailbox at: form3@cdc.gov

 

 

 

 

[b31133

 

a; a? ?orrespondences regarding this TLR investigation, please be sure to include
I I as well.

 

 

 

 

 

 

Thank you in advance for your cooperation and collaboration in this critical investigation.

Sincerely,
'142 USC. 2623

.-.I

   

Form 3 Site Visit Coordinator

 

[bjf3ji42 U.S.C. 2523[h3

 

 

 

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Cli?on Rd. NE, Mailstop A416

Atlanta. GA 30333

Item-:42 use. 252mm I

 

DEA i" Vision: To be the preeminent resource for the safety and security agents and toxins.

This document is intended for the exciusive use of the rertptentrs) named above. it may contain sensitive informatmn that ii? protected. or
con?dential?, and it she Iiid not be disseminated. distributed, or copied to persons not authorised to reiteive such information. Jyoti are not the
intended any dissemination. distribution. or copying ts strictiy prohibited Hyou thinh you have received this document in error. 
the sender i'tnniedt'otei'y and destroy the originoi. Thank you.

Accession Number: Specia191714 Page: 154 Sean Date: 2014?09?17 COPY

 

 

 

 

 

 

 
 

 

 

   

 

 

 

  

 

 

 

 

 

 

 

 

 

 

252 i:  
From: 
Sent: Thursday, April 22, 2012 12:51 PM
To: min-?-   
Cc: =i    

Subject: FW: Airflow in  252
{bills}
Please see email below, dated February 
DSAT)
?Se'nt: Thursda April 12, 2012 12:42 PM
:3fo Tar".  CDCIOPHPRIDSAT)
(CD PHP SAT)

Hetesouee

 

 

From 

a A ril 10, 2012 6:31 PM
 

        

 

 

 

 

 ..



{and copied personnel) on the day of Ir lastm,
not send me any more informatio, - has been in contact with  
 ,and other ARE personnel. i also read the memo from I  -- 1 
referring to, however I am sure she would tell you if you asked. Does the have any information? i will

 

 

 

 

 

 

 

 

 

 

 
 
 

 



 

 

 

 

 

  
 
 

?Fram? cocrocooroSI-IE)

Sent. Thursda February 16, 2012 4:16 PM

Cc: Powell, Nathaniel Williams, Allison
MM CUDEIOIDJNCEZID)
teat 

 

 

 

 

 

 

 

 

 

ibii?';

Thanks we will look into it.

 (cociopnpwosm
It: Thursda February 16, 2012 04:13 PM
 (CDCIOCOOIOSHB

 

 

 

 

 

 

1
Accession Number: Page: 155 Sean Date: 2014-09-17 COPY

[bil?l

 

Cc: Powell,  (cociomincezm); Williams, Allison

 
 

 

 

 

mile: Goggua?ernoon at 3'

i
This morning I was a part of an escorted group that walked through of the clean areas in the vivarium of Bldg.and
wanted to make you all aware of a circumstance that the group encountered.

  

As the group stood outside the door iigi?i? 252 in the clean corridor, the ARB technician inside opened the door to the

animal room. As the door closed a very noticeable puff of air could be felt coming through the slit in the window out
- molu._ - - - - - 



       
   

[bll?i

 

 

 

F?l?l

mils;-

 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers fo Disease Control and Prevention

1600 Clifton Rd. NE MS A46

?i-l?n-nl-Ih Fal- 
ibiis;

 

 

 

 

Vision: To be the preeminent resource for safety and security of biological agents and toxins.

2

Accession Number: Specia191714 Page: 156 Sean Date: 2014?09?17

COPY

 

 

 

  

 

 

 

 

From: . 

Sent: - Tuesda Aril 10, 2012 3:4? AM 

To: "i Em" 
Subject: FW: Request for DSAT Training

 

Theft, Loss and Release Coordinator
Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS 

 GA 303 33

262 iihf.

 

 

 

 



DSAT Vision: To be the preeminent resource for the safety and secoritv of biological agents and toxins.

This document is intended for the exclusive use of the recipient named above. it mav contain sensitive information that is protected. privileged, or
confidential, and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If vou are not the
intended recipient, anv dissemination, distribution, or copving is strictlv prohibited. if you think vou have received this document in error, please
notifv the sender immediater and destroy the original. Thank vou.

 

libllj?i
- From 
o- 09: 2012 5:40 PM
zazai?l?a;  CDCKOPHPRIDSAT)

  

 

Subject: FW: Request for DSAT Training

Fyi

rams}

 

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

?h?l?l-I
?33.53

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

1
Accession Number: Page: 157 Sean Date: 2014-09-17 COPY

 



Sent: Monca A ril 09, 2012 4:02 PM

agree this; - Weyant, Rob (CDQOPHPRIDSAT)
Subject: FW: Request for DSAT Training

 

 

 

 

 

(bite Druwwanlmand 

 

 

thought this would be of your interest. have another email from - 3i" 3
DSAT in future training sessions. I am not sure what exactly happened since that email

 

I (CDCIOIDINCEZID)

     
 

 

. - DCJOIDINCEZID)
  
Williams, Allison ?33?33?34 ??83-?34 
(CDCIOCOOIOSHE)

Subject: RE: Request for DSAT Training

 
  
 

 
   
 

 

thit?ktbit?l

 

 

 

2
Accession NUmber: Specia191714 Page: 158 Sean Date: 2014?09?17 COPY

 

 

From: ?Jim? 
Sent: Monday, April 09, 2012 10:49 AM
To: Powell, Nathaniel (CDCIOIDINCEZID)
Cd mars: mine: 
Subject: Request for DSAT Training

 

 

 

 

 

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to st edule a

 

 

 

 

 

  

. . . . 
training session for the last week of April, 2012 for DSAT FTEs (5 partialpants}. lam waiting to hear back from Ugo}?
335:; $33  Ito decide on an exact date. To answer your question: the requirements to enter the  last time

 

were TB test and proof of progra mf respiratory fit test. Again thank you for your support.

3
Accession Number: Specia191714 Page: 159 Scan Date: 2014-09?17 COPY

 

[mi-3:4 uses



 

 

  

 

 

 

Fram: mi!?  

Sent: .Wednesda June 2012 12:10 AM

To: 2625? IrcoczOPH 

Cc: 

Subject: 

Attachments: (We) Form 3 List with 
emim??

 

 

 

(bi
Re-verified the list one more time. Attached is the Building  entries highlighted in red. The Form 35 were sent this

morning. can pull those files, copy and make duplicate files from the original files. Wish I was there to lend a
hand.

Time to get some sleep, it has been a long day. This place is in the middle on nowhere.

{bt3z4 
2d2aihj?l??tw  

262:: hi   

Theft, Loss and Release Coordinator

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A-46

Atlanta, GA 30333
(pirate use. 

 

 

 

 

 

 

 

 

 



DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the

intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Specia191714 Page: 161 Sean Date: 2014-09-17 COPY

 Form 3, Report of Theft, Loss and Release


     

II - ai 3' 
7993mm?? Fntiname 1 Cit-y State Entity?l?ype Selectngent?uxin e? 

Risk Assessment 
Type level



1 A 
U.S.C. 262mm

 

 

 

Controlled Unclassified InfOImaliCIn
Printed at 12:01 AM [formedy SBHSitive But Unclassified) Page 1 of 2

Accession Number: Specia191714 Page: 162 Sean Date: 2014?09?17 COPY

 Ferm 3, Report of Theft, Loss and Release
DATA ILE A 

     



Bins aletv Einsafetv
:?ntiry Name Ciw State Entity Type Seiezt Agenth-axln

it I  of . -
iHepur-I Date Year - Risk Assessment
I Type Level



RE part

 

Controlled Unclassified Information


Accession Number: Specia1917l4 Page: 163 Sean Date: 2014-09-17 COPY

 

 

 

 

 



Sent: Tuesday, June 26, 2012 4:53 PM
To: one (CDCXOPHPRIDSAT)
Cc: 'ibiiei 
Subject: Farm 35.- Building
Attachments: CDC 013008 Form 3.pdf; CDC 013112 Form 3.pdf; CDC 022410 Form 3.pdf: CDC 051911

Form 3.pdf: CDC 05250? Form 3.pdf

 

ibii?l

 

 

 

I pulled up all the archived scans for CDC. Attached are the ones submitted that involve Building

If you need additional information, let me know.

 

(bi 3H2 use 
202 Eith 

 

 

 

Theft, Loss and Release Coordinator
Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE M5 Iii-46

G0. arr-m

(mi: )z42 use. 

 

 

 

 



DSAT Vision: To be the preeminent resource for the safety and securitv of biological agents and toxins.

This document is intended for the exclusive use of the recipient named above. It mav contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If vou are not the

intended recipient, anv dissemination, distribution, or copving is strictlv prohibited. If vou think you have received this document in error, please
notifv the sender immediater and destrov the original. Thank you.

1 .
Accession Number: Specia191714 Page: 164 Sean Date: 2014-09?17 COPY

 

 

Page 155

use. 262a{h)

 

 

 

 

Page 156

use. 262a{h)

 

 

 

 

Page 15?

use. 262a{h)

 

 

 UD- J'l'Ll rom: [Chili-42 USE. 2623M: i ll: 

 

 

 

 

I I - 
Incident report, January 30, 2008 [prepared lfii Eel-42 laboratory:

 

 

 

    

  failed during the pre-run.
Autoclave failure was discovered when support staff attempted to empty autoclave the morning of January
ibii?]  who in turn contacted F-SE (Four Seasons . I - 'e - ring). On January 30 at
We]  nptvaccinated :fo  

:autocl ave and attempt-repairs. Because. the material in the. autoclave {one pan of tissue culture materials
from infected cells, one-pan of scissors and forceps from infected mice neer'opsies, one bag of mbuse cages
Efrem infected mice, one be of bedding from. infected mice, and onebag elf-used laundry .was infectious and
the run had not completed, {i?at?oinnel :"arternpted'ito open the autoclave-from the side, so that the
materials in the autoclavecould he removed and-the autoclave-disinfected.prior to attempted repairs by
employee. run would-ner?cpea?f?
slab re uested thati'the'inner The attempt to 
cor no? the FSE employee
a present. 3m lovee subsequently closed the clean side door and entered 
(?53332  -- sin-person inside the lab and informed her of what had. happened. She instructed him to
back to the

(bl(3l142 use. 
 

  

 

'speakto he let:- director (myself) who was also in the-of?ce area. I escorted the FSE emplo 
lab an a? t' - 'rther noti?cation, which he did. 1 called  
(blt?l arrived ?only thereafter-

        
 

   

Due to strong. exhaust in the area of the autoclave, any material that may have escaped through the open

clean-side door'was likely'to be drawn upward-10Lde {he-exhaust. The autoclave and surrounding area was

disinfected using Micro-Chem and 70% FSE employee was directed to theabe-r?cryeait- 

shower {adjacent to the autoclave area). I?lis outer clothes were bagged and later autoclaved. His shoes and 262mm?

personal items 1, watch, etc.) were disinfected with 70% New outer clothes were provided by

ah) ill escorted the-ESE employee to the clinic for

Ines . 1? ?ts-area was ?150 disinfected With 
{cicajz42 use. zezami

     
  

@5142 USC. 

 

   

 

 

 

 

Remediation: Autoclave needs to be ?xed so the (b39142 ab personnel are able to control the opening of
doors including during a failure during?building construction. On
every other autoclave in building oor is insideanddoor Z'is oursidc (clean). Thegg 

desienati ns-are reve - - - ve I 'e i described. The manual
override controls need to be modi?ed so that the doors can be correctly identi?ed. IFSE ersonn?el need'to'be
better trained on this issue. Lastly, while the lab director, ESE building supervisor, and re
vaccinated, the-FEE employeenaes. not, at additional SE. employees is recommended. -

(bicaizet'z use. zezath) ?494) Mel-J -

   
 

  
  

     
   

 

 

 

 

Accession Number: Specia191714 Page: 168 Sean Date: 2014?09?17 COPY

Ioir-ti?t-t raid 

 

rrom=uatr DHUENI

.I - 

Hui-Ht. no 
~13 - .

 



 

FACILITIESPLANNING INCIDENT REPORT
Manager: Date and Time of Call: ciiaorzotis
wits" I 02:00 am. pm.

gangs ?'ocation:

Facility it Bidg# i Fitters Rooms Other
to 34203.0 262 ih
Raybat Ii ii i at I

Incident Location
?fditferent from calleHS}

Facilitv? RUYDEI Bloom Floodligmi Easel Ewl Other

Incident Description
{Check all that air-phi}

Fire I Ci Chemical

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Security Related CI Mechanical
Bomb Threat . Winner (Please describe]
Weather-R elated Potentch Exposure'to FSE employeeand Autoclave'tech (bii?i

 

 

Incident Summary:

While readying a pass-through autoclave tor repetr,wes- attempting to open the side door
of this autoclave using manual con-rots ess area. Thisaction allows access to the
chamber or the autoclave from the  side forlaboratorian] to remove contaminated
materials. This a tion also allowslibi Ito decontaminate interior of the autoclave thus making it
ready for repair-shaving forgotten the manual controls from this autoclave -. -.- -
mistakenly seuenced the door nonnaliy'and op . . . -  side door as a reach.
are st- 

was on the side of the laboratory waiting for to manually open the
what had occurred. took appropriate actions to reducerelimlnate possible exposure to personnel.

 

  
   
   
   

  

Immediate Remedvr Repair Time:

Repairs for the original request have been completed. Additional signage Is in place to notify all service
technicians-of the-current manual operational de?ciencies ofthie autoclave.

initial. Noti?cations
Was one called? Yes 13 no

 

 

 

 

 

 

Was-Security called? Yes No titles Femorohio called? Yes i3 No

 

Long Term Remedy:

The Getinge Company was noti?ed of the manufacturing de?ciencies for the manual functions of
this piece or equipment. service'representative for Getinge, was dispatched to
examined the autoclave. He sent an incident reporttCompany Engineering 
review. Gatinge Company will be communicating with and CDC regarding the
necessary actions and measures needed to remedy the current problem. All Departments
involved in this report will be updated when manual functions and other repair actions, if needed.
are completed by Gettnge Company.'A copy of Getinge Company incident report is available if
required. Note: Automatic operations or this autoclave are functioning normain at present.

 

 

. [bii?i
Signgtu re: I .. . I
one c.1322 rel. o1raooa. Addba'Acrchet so Eicotionic View. attends

 

 

 

 



 

 

 

Accession Number: Specia191714 Page: 169 Scan Date: 2014-09-17 COPY

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Acceg?i?m?? Page: 113035516m??3atez 20i=4qea?tl?=94?OPY

 

 

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?all - (CDCIOPHPRIDSAT)
From: 

Sent: Thursda ,Ari512, 2012 12:51 PM
To: ?93163 A I 
Cc: agate-SC 9 

[El ?2536]
Subject: FW: Airflow in 

 

 

 

 

 

 

 

 

 

in 3:4 .30.
.- . 

 

email below, dated February' 

 

 

 

 

 

 

 

    

 

(0'15) 
Sent: Thursday, Aaril 12, 2012 12:47 PM

@151 T9:  CDCIOPHPRIDSAT)
Cc: (?1?53  .(cocroPHP DSAT)

3 :4 . . 

 

 

 

 

 

gemigre?cDumaanan

 

 

 

 

 

 

{mm til 10, 2012 6:31 PM

Tn:  . (CDCIUPHPRIDSAT)

(P115) Ce:  minis: 
  

12 0.33. 

262a?l] 

 

 

 

 

Below is the email (and his response) that i sent to 3' 3  {and copied ARE personnel} on the day of our last

We) '1 .  did not send me any more information but I uess he has been in contact 

113115] and other ARE personnel. 1 afso read the memo froml if?? 
referring to, however I am sure she wouid tell you if you asked. Does the  
be back in the office on Friday, but until then, I will answer emails when I can.

 

 

 

(bll3lziz g,
2625M:  

 

 

 

 


I .1. bruary 16, 2012 4:16 PM
TOE, (CDCIOPHPRIDSAT)

Williams; Allison
(bjl?j (CDCIOIDINCEZID)


 we will look into it.

(pita): 
252a; [Om-r

 

 

 

 

 

 

 

 

 

 

 

    
 

(CDCIOPHPRIDSAT)
ruary 16, 2012 04:13 PM


    

 

1
Accession Number: Specia191714 Page: 211 Sean Date: 2014-09?17 COPY

 

 

[bi-f5? Williams, Allison
coca (CDCIOIDINCEZID)

 


3
33? et al

 

 

 

 

 



 

 

Good afternoon

?9

 

 

 

 

This morning I was a part ofan escorted group that walked through of the clean areas in the viva rium of 
wanted to make Wu all aware ofa circumstance that the group encountered.

 

. (more . . . . . .

As the group stood the door of In the clean corridor, the ARB Inside opened the door to the
animal room. As the door closed a ver bnrigtice ble puff of air could be felt coming through the slit in the window out
into the "clean" cerridor. I was told tn;c 3? that this room does not house infected animals at the present time.

 

 

 

 

[bili??

 

 

 

 

(W5)

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers to Disease Control and Prevention

1600 Clifton Rd. NE M5 A46

Atlanta. Ga. 30333
(MB)

 

 

 

 

Vision: To be the preeminent resource for safety and security of bioiogicoi agents and toxins.

2
Accession Number: Specia191714 Page: 212 Sean Date: 2014?09?17 COPY

 



From: 

 
  

Sent: Thursda Aril 12. 2012 3:30 PM
To: ?Die? 
Cc: - 

   

ll. 
Subject: RE: Letter draft 

Thanks (bids) I?ve added one or two items to the list you provided, not sure if_ mail-corte-spendeoceW?  

requests a Form 3 be submitted, if not, here we are covered. It appears that you captured the essence of the discussion
this morning-again, thank you.

 

(pirate use. 262ath

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop A46

AI-l-snI-u TIFF-213
l-2 USC. 
262mm  ..

 

 

 

 

USA ir'isit'nt: To be tire preeminent resource for tire safety rind secnrirv of in'oiopit'ni agents and toxins.

This document is intended for the exciusive use oi the recrpienttsi named above. it may contain sensitive information that is protected. privileged, or ooniidontiat,
and it snoutd not be disseminated, distributedr or copied to persons not authorized to receive such information. it you are not the intended recipientts). any
dissemination, distribution, or copying is striotiy prohibited. it you think you have received this document in error, ptease notify the sender immediateiy and destroy
the on?ginei. Thank you.

 

 

 

. 
Sent: Thursda April 12, 2012 2:42 PM

ibii?i To; - 

(bits) 
Subject: Letter draft

    

 

 

 

 

 

Here is some suggested wording for the letter to ?3:93:42

 

 

 I     I
'1 .         

containment area wearing PAPRs and showered out upon exit. On February 16, 2012 at 3 am,
second group to the gigarjum-I 

   

 

 

 

    
  

  IThe second group was given the option of tourin the clean outside of

COMBinment; they ?1059 this org?i 4:12? did not wear PAPRs. According to escort 
stood outside the door of room use. 2 in the clean corridor. the ARB technician inside opened the door to the animal
room. As this door closed, a very noticeable puff of air could be felt coming through the slit in the window out into the

clean corridor.

. 

 

 

 

 

 

1
Accession Number: Specia191714 Page: 213 Sean Date: 2014-09-17 COPY

(bil3i
262a(

2
Accession Number: Specia191714 Page: 214

:_42 u. c. 
h. 

  
 
 

An incident report was provided to DSAT from CDC. This report states that prairie dogs were convalescing in the
holding room after an experiment with vhe BM BL states that all persons working in or entering
laboratory or animal care areas where activities with ?3i 

satisfactory vaccination. The two groups of visitors to the vivarium included individuals who had not been vaccinated for

 

rbses.

In order to determine whether the visitors on February 15 and 16, 2012 were exposed to a select agent, please provide
the following information by COB April 20, 2012:

0 Please submit a completed Form 3 along with an executive summary (narrative) of events including timeline of
what occurred.

0 Please provide details on which rooms within the containment block were entered by the first group of visitors.

Please provide information on the work activities being performed in all of the vivarium rooms during the time
intervals of the visit.

a What isfare the entry requirementls) for entry into the containment block?

- Explain the procedure for preventing entry of unvaccinated individuals into areas where vaccination is required.

I Please confirm the fast time that active work was performed in procedure room 
second group.

- Provide details on the animal housin used throughout the containment block and including any animals housed
at the time in animal holding roomm 

a Previous HVAC verification test results provided to DSAT for the Building ivarium space were qualitative and
lacked pressure trending data. Please provide pressure trending data for the vivarium containment block during
the time of the second group's visit on February 16, 2012.

 

 

 

 

 

 

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1500 Clifton Road, M5 int-46

Atlanta, GA 30333

Phone: 404-718-2012

 

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This docvment is intended for the exclusive use of the recipientis] named above. It may contain sensitive information that is protected,priviledged, or con?dential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientls}. be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

Scan Date: 2014?09?17 COPY

 

 

(CDCIOPH PRIDSAT)

 

 

 

 

 

 

 

 

 

 

 

 

 

From: 

Sent: Fridav April 13 2012 3:08 PM

To: (2523523322 

Cc: (cocxoPHPR/osan  
l?iJ?i'J  (cocroPHpR,xosan, {cocropupwosm}; (bile)

(cocropHpazosan
Subject: Centers TLR Letter 
Attachments: Centers TLR Letter [2).doc

 

(mete
Good afternoon use. 

 

 

 

Please be advised, the letter attachment denoted in this memo will require your immediate attention and collaboration
in helping us to understand what happen during the visitor?s tours of the Vivarium in Building 
a TLR Incident and, therefore, subject to an investigation.

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfully,

 

42 use. 
262511: 3 

 

 

 


Accession Number: Specia191714 Page: 215 Sean Date: 2014-09-17 COPY

 

 

(MB) 42 use. 
2523?;   

From: 

      
   

  
    

 

 

 

 

 

 

 

 

 

 

 

 

Sent: Frida i 13 .2012 3:23 PM

To:  .

Cc: . ewe tcocroeHPRtoSAT); 
(PW 


Subject: FW: Centers TLR Letter 

Attachments: Centers TLR Letter (2).doc

Correction to previOus sent email:

The 3rd paragraph of the letter should read: 14?? and 16m instead of February 15"" and 15?1 .- Please note this
change on your copy.

Thank
{1:393:42 

 


.se. 262ath

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop A416

Atlanta, GA 30333
use. 
25251; ..

 

 

 

 

 

ELSA Vision: To be the preerninent resource for the safety and security of hioiogicrti and toxins.

This document is intended for the exciusive use of the recipientis) named above. it may contain sensitive information that is protected. privibged. or coniidentiai,
end it shouid not be disseminated. distributed, or copied to persons not authorized to receive such iniormation. it you are not the intended recrpientisi, any

dissemination distribution. or copying is strictiy prohibited. it you thinir you have received this document in error, piease notify the sender immediatth and destroy
the original. Thank you.

 

(mists use.
zszath mm: 

 
Sent' =rida Aril 1

3,r 2012 3:08 PM

 

 

 

 
      
 

 

 

 

 

 

<bi<3ii4ttltiw2 is? 
    .: I  
(are 

 TLR Letter (2)

 

 

 

 

 

Please be advised, the letter attachment denoted in this memo will require your immediate attention and collaboration

in helping us to understand what happen during the visitor?s tours ofthe Vivarium in I
a TLR Incident and, therefore, subject to an investigation.

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfully,

 

1
Accession Number: Specia191714 Page: 216 Sean Date: 2014-09?17 COPY


in.? 

 

 

 

 

 

 

 

 

   

  

 

    
 

 

4"
DEPARTMENT OF HEALTH AN HUMAN SERVICES Public Health Service
its? Centers for Disease Control
eh and Prevention (CDC)
Atlanta GA 30333
April 13, 2012
(bli3li42 U-S-C- I
2323mm) . 
Centers for Disease Control and Prevention
1600 Clifton Road, NE, Mailstop Ae22
Atlanta nu. ama?t .
?3133242 U.S.C. 252afh]
to a :42usclbll?l
(bier   . 
  In; the 9

 

 

(more 
262a?hj 

 

--  ivarium space. Participants entered the containment area wearing PAPRs and showered out

upon exit. On February 16, 2012 between a 41:30 am, to the Leiggt?U-S-C- i
lbll?l vivarium:l  .. I 
IThe second group was given the option of touring the clean corridor outside
 of containment; they chose this option and did not wear PAPRs. According to escort  
the second group stood outside the door of room in the clean corridor, the ARB technician
inside opened the door to the animal room. As this door closed, a very noticeable puff of air could be

. felt coming through the slit in the window out into the clean corridor.

 

 

 

 

 

An incident report was rovided to DSAT from CDC. This report states that - rairie dogs were
co nvalescing in the M334 holding room after an experiment with 

that all persons working in or entering laboratory or animal care areas where activities with

 

(ovate use. 
virus are being conducted should have evidence of satisfactory vaccination. The two groups of visitors to
the vivarium included individuals who had not been vaccinated foriruses.

 

In order to determine whether the visitors on February 15 and 16, 2012 were exposed to a select agent,
please provide the following information by COB on April 20, 2012:

0 Please submit a completed Form 3 along with an executive summary {narrative} of events
including timeline of what occurred.

0 Please provide details on which rooms within the containment block were entered by the ?rst
group of visitors.

0 Please provide information on the work activities being performed in all of the vivarium rooms
during the time intervals of the visit.
What isfare the for entry into the containment block?

it Explain the procedure for preventing entry of unvaccinated individuals into areas where
vaccination is required.

1! Please confirm the last time that active work was performed in procedure room (b39334 prior to
the tour by the second group.

1: Provide details on the animal housing used throughout the containment block and including any
animals housed at the time in animal holding room 

Accession Nomber: Specia191714 Page: 218 Sean Date: 2014-09?17 COPY

a Previous HVAC verification test results provided to DSAT for the Building ivarium space were
qualitative and lacked room differential pressure trending data. Please provide pressure
trending data for each of the rooms in the vivarium containment block during the time of the
second group?s'visit on February 16, 2012.

 

. . . (mist-42 use. 
If you have questions con ce this correspondence, please contact  
the Form 3 mailbox at: 

'5
-orrespondences regarding this TLR investigation, please be sure to include: 3'

 

 

 

as well.

Thank vou in advance for your cooperation and collaboration in this critical investigation.

Since relv,
ibii3i'42

Form 3 Site Visit Coordinator

 

use. 262ath

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Maitstop A446

?m
use. 2azath]

 

DSAT Vision: 1" be the preeminent reSont-ce for the safety and security agents and toxins.

This document is intended for the excituive' use oftitc rccipt'entt?s) nomm? above. it nut}; contain sensitive that is protected. priviicycti, or
crtn??'etitt'at'. and it Shani-d not be disseminated. distributed, Gr copied to persons not authorized to rec?eivesncit ij'yun are not tin:

intended atljr' dissemination, distribution. or copying is strictidr prohibited. think you have: recuivoti this in error. pimsu
noti?' the sender immediate-3' tutti tin? originoi. 

Accession Number: Page: 219 Sean Date: 2014-09-17 COPY

 

 

(CDCIOPHPRIDSAT)

 

   
   
   
 
 

 

 

   

 

 

 

 

From: ?33142 a] 
Sent: 3, 2012 3:45 PM
To: 
Cc:
Meechan, Paul J. 
{cocrocooxoscpx ?33(6) 
Subject: Re: Centers TLR Letter 

 

 

I am currently out of the office for the rest of this afternoon but will be he - - to respond immediately and
collaboratively to assist in the investigative process. Please call me at so I may begin to immediately
address actions required at this time, otherwise, I will ensure that all items requested in your attachment are addressed
by April 20, 2012.

   

I look forward to speaking with you this afternoon.

Sincerely,

 

 

  
 
 
  

 

 

(CDCIOPHPRIDSAT)
2012 03:0? PM

 

 
   

 

 

 

r:  (bits)
- 
- We? (CDCIOPHPRIDSAT)

 

 

 

Subject: Centers TLR Letter (2)



Please be advised, the letter attachment denoted in this memo will require your immediate a
in helping us to understand what happen during the visitor?s tours of the Vivarium in Building
a TLR Incident and, therefore, subject to an investigation.

tention and collaboraetit?'fEnLI
 

 

so. 

 

 

 

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfully,

 

lbll3li
252arr

.2 use. 

 

 

 

1
Accession Number: Specia191714 Page: 220 Sean Date: 2014-09-17 COPY

 

  

 

      
 

    
   

 

 

 

 

 

 

From: W) 

Sent: Friday, April 13, 2012 4:01 PM

To: 

Cc: (?0?53  
ll 
Meechan, Paul J. [cocrocooxosmr Henderson. Joseph
icocxocooxosem; 


Subject: RE: Centers TLR Letter (2)

 

Thanks mil-33?? for your prompt response. I called the number listed in your reply but it went straight to your voicemail.
Please note, April 2i]th will suffice and, therefore, give you time to gather the facts as they unfold. Again, thank you and
have a nice 

 

USE. 262mb}

 

 

JSAT

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop i146

Atlanta, GA 30333
(bits): i2 use 

 

 

 

 

USA Vision: To be lite resource for the and security of biological agents and titties.

This document is intended for the exclusive use of the named above. it may contain sensitive information that is protected, privileged. or confidential.
and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. it you are not the intended reaipienits), any
dissemination, distribution, or copying is strictly prohibited. it you think you have received this docament in error, ptease notify the sender immediately and destroy
the original. Thank you.

 

 

   

use 

 

 

 

   

  
 

 

 

 

3* 31 -  
Sent: Friday. April I 3, 2012 3:45 PM
?ghts-Ct 
Egg;- -  ?it? 
Meecnan, Paul J. 

 

  

 

lei-berserk 

"Centers TLR Letter (2)



 

 

i am currently out of the office for the rest of this afternoon but will be happy to respond immediately and
collaboratively to assist in the investigative process. Please call me at ?(3332 so I may begin to immediately
address actions required at this time, otherwise, I will ensure that all items requested in your attachment are addressed
by April 20, 2012.

I look forward to speaking with you this afternoon.

Sincerely,

lbll324zu_3?_?  I
252a h?i 

 

1
Accession Number: Specia191714 Page: 221 Sean Date: 2014?09?17 COPY

 

.2 use. 

 

 

 

 

 

 

 
    

 

 

2e2acr
(pirate use. 23

Set - ,2012 03:07 PM
(mom use. 

  

 

 

 

 

 

use 
2528131] Clogginaftern??n. 


 

 

Please be advised, the letter attachment denoted in this memo will require vour immediate He tion and collabpb?aati?w 
in helping us to understand what happen during the visitor's tours of the Vivarium in Building 
a TLR Incident and, therefore, subject to an investigation.

 

 

 

 

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfullv,

rm?-
252a( . 

2
Accession Number: Specia191714 Page: 222 Sean Date: 2014?09?17 COPY

 

(bil?i



 

  
  
 

[0183242 U.S.C. 2523

     
     
 

 

 

 

 

 

 

 

 

From: in, 
Sent: Friday, April 20, 2012 4:[bjzi?jzv 
01:63:42 05135252301: I II
tcocgoaH --   .. 
tcocroeH (bite) tcocroeH PRIDSAT) 
Subject: RE: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours

of the Building Vivarium

 

(b]i3]:42 usog I I I I I
262aihiTh-a-n-kslib?i??  this email acknowiedges receipt of said responses.

 

 

 

Best regard,

 

12 use. 

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A46

Atlanta, GA 30333

(bits :z 2 use. 5;

gagath   

 



 

 

 

USA Vision: To be this preeminent resource for the safety and security ofhioiogictti agents and toxins.

This document is intended for the exciusive use of the recipienit's} named above. it may contain set-reittve information that is protected. prettieged, or ooniidentiei.
and it shouid not be disseminated, distributed. or copied to persons not authorized to receive such iniormation. it you are not the intended recipient is). any
dissemination. distribution, or copying is striotiy prohibited. it you think you have received this document in error, piease notify the sender intmedietety and destroy
the originei. Thank you.

 

 

 
     

 

 

- . 
ll 20, 2012 4:IW- 

 

 

 

 

{by
Subject: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours of the Building (at: ivarium
42

 

 

 

 

 

Per your e-mail and attached letter oprril 13, 2012, please find attached the CDC response to your request for me to
provide additional information regarding incidents that occurred in the Building ivarium during tours on February 14
and February 16, 2012. 

File: Cover Letter-FINAL-04202012.pdf File: CDC Response to 05m Request Date 04132012


1
Accession Number: Specia191714 Page: 223 Sean Date: 2014-09?17 COPY

Respectfully submitted,

252th 

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Cempliance, Revbal Campus
1600 Clifton Road. NE. Mail Stop 

Atlanta. GA 30333


 

[bj:[3j::4
252301:

 

 

 

2
Accession Number: Specia191714 Page: 224 Sean Date: 2014?09?17 COPY

 

 

 

 

    

 

 

 

 

 

 

land?ll?  
Sent: Friday, April 20, 2012 4:59 PM
it?; I  i

Subject: FW: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours
of the Building .iivarium
42'
FYI
Thank:
uses
2523i? 

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop 

Atlanta, GA 30333

?3:42 I
2523i    

Vision: To be the preeminent resource for the safety and security ofbioiogicni ngeitts and toxins.

This document is intended for the exciushre use of the recipientis} named above. it rnaj.r contain sensitive iniormation that is protected. privileged. or confidential.
and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. ifyou are not the intended any
disSemination. distribution. or copying is strictiv prohibited. ifyou thinit you have received this doCument in error, piease notify the sender immediately and destroy
the original thank you.

       

 

 
      
 

  
   
   

   

   

    

?11:23:14 . ..
2625i?: From-t 
Sent: Frida Aril 20, 2012 4:[bil334__IU-5-C- gm ..  

 

 


Subject: CDC Response to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours of the Building Hiva'rium
42

1:93:42 so.


Per your e-mail and attached letter ofitpril 13, 2012, please find attached the CDC response to your request for me to
provide additional information regarding incidents that ocwrred in the  

and February 16, 2012. I

CDC REFEREE to
Request 

mitts}

 

 

1
Accession Number: Specia191714 Page: 225 Sean Date: 2014-09-17 COPY

 

?3:13:42 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333


2523M: 

 

 

 

 

2
Accession Number: Specia191714 Page: 226 Sean Date: 2014-09-17 COPY

 

  

ibii?:

.. 

From:   -. 
Sent: Aril 4, 2012 8:14 PM

     

 

 

 

   
 
 
  

 

 

To: 

Cc: 
2523 


Subject: Re: Meeting for April 25, 2012

Thanksfor vour thoughtful consideration to our request. I will inform vou ofthe specific details on tomorrow as
soon as theyI become known. Your gratitude and partnership in this endeavor is appreciated. Goodnight for now!

 

:42 
252511} 

 

 

 

Original Message 


Sent: Tuesda April 24, 2012 06:20 PM

  
   

 

 

 

 

[01:26} i - LSILS   
Subject: Re: Meeting for April 25, 2012

 

ibii?:

 

 

Would you like to meet?

Best ree rds,
ibj:[3j: 4_2 0.3.00

 

2623 

 

 

 



.I-

SentzTuesda A

  

 

 
    

 


ril 24, 2012 04:03 PM
itfgifit?dci 
. 
Subject: Meeting for April 25, 2012

 

      

     

 



 

 

0:03:42 0.30.?  
2020013 Dear. ?303-42

 

 

 

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your station tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
of the Building Virvarium Tours. Again, my apology for the short notice, and thank vou in advance for your support
and considerationis} to DSAT's requests.

PS: I am not in the office at this writing, this message is being sent via my BlackBerrv. Feel free to respond at your
earliest convenience. Most 

thii?? 

 

 


Accession Number: Specia191714 Page: 227 Sean Date: 2014-09-17 COPY

 





$330?  

Sent: April 25, 2012 7:18 AM
 
Cc:

 

 

   
 
 
     

(bi-.03!

Em {cocroSELsr



  
 
 

 

 

 

 

 

[bl3z4 DC prDSAn
Subject: RE: Meeting for April 25, 2012

 

uses
252m 

 

 

 

We have Room 3113 in Building 20 already reserved for a meeting at 1:30, so we'll just slide that meeting back to 2:15
and ask that we meet with DSAT in Building 20, 3113 at 1:30 if that will work with you. SevEral of the individuals that
were to be in attendance for the original 1:30 meeting we had the room reserved for will need to attend your meeting
anyway, so this will work well.

Many thanks in advance for your consideration of this request.

Best regards,

252w: 

 

 

 

 

Centers for Disease Control and Prevention Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

no I?ill
2 
252m: 

 

 

 

 

  
 

- 



2523(0;  

    

- - -- 1- 24,2012 3:14 PM
252aih3To. 



I i: 
[0033242 U.S.C. 2523

 in.

 

 

 

 

 

 

 

 

 

 

 



2min: 'iafoits-or your thoughtful consideration to our request. I will inform you of the specific details on tomorrow as
soon as they become known. Your gratitude and partnership in this endeavor is appreciated. Goodnight for now!

 

 



252mm From. L5 {15 pp p0]

 

 

 

1
Accession Number: Page: 228 Sean Date: 2014-09-17 COPY

Sent: Tuesda April 24, 2012 06:20 PM

[013142 
202aihj: 


   
   



Cc: :c-DGMSELsstaE?bii ..

Subject: Re: Meeting for April 25, 2012

  
 

 

 

Where would you like to meet?ase
icocyoeHParDSAT}
1313342 .3 24, 2012 04:03 PM
?s??ain; 

 

   



Subject: Meeting for April 25, 2012

 




252301;: gar

My apology:r for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
ofthe Building irvarium Tours. Again, my apology for the short notice, and thank you in advance for your support
and considerationis} to DSAT's requests. 

PS: I am not in the office at this writing, this message is being sent via my BlackBerrv. Feel free to respond at vour
earliest convenience. Most 

Resoectfuliv,
2 
202a[f: 

 

 

 

 

2
Accession Number: Specia191714 Page: 229 Sean Date: 2014-09-17 COPY

 

 



 

 

 

 

          
 

 

 

 

 

I
From 
Sent A ril 25, 2012 9:(cocrompwosm);    

Subject: RE: Meeting for April 25, 2012

2523 et a"

 

 

 

Thanks for rearranging your schedules to meet with us to clarify and discuss a few points of interest in going forward in
resolving this investigation. We look forward to what we believe will be an instructive and useful discussion.

Please note, due to a prior engagement and a conflict in my schedule with another scheduled event, it is unfortunate
that I will not be in attendance, but knowing that DSAT finest will be there -- have confidence it will be a great meeting.

Again, thanks for honoring our request on such a short notice.

  

Respectfully,
. . .

Form 3 Site Visit Coordinator
?31:13 412 

 

 

 

 

 

Preparedness and Response Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop A-46
Atlargta GA 30333

[bliS :42 USE.

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientls) named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientfs), any dissemination, distribution, or
copying is strictly prohibited. lfyou think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

 

 

    
 


g.
252%; (gm, 
?iy, April 25, 2012 ?:18 AM
Ebs?rf??if; I RID SAT)

 

 

 

  


I 5?

 

 

1
Accession Number: Specia191714 Page: 230 Sean Date: 2014-09?17 COPY

 ibj'ei?l

We have Room B113 in Building 20 already reserved for a meeting at 1:30, so we'lljust slide that meeting back to 2:15
and ask that we meet with DSAT in Building 20, 3113 at 1:30 if that will work with vou. Several of the individuals that
were to be in attendance for the original 1:30 meeting we had the room reserved for will need to attend your meeting

anywav, so this will work well.
Many thanks in advance for your consideration of this request.

Best regards,
[0013242 
252th 

 

 

 

 

Centers for Disease Control and Prevention Select Agent Compliance, Rovbal Campus

1500 Clifton Road, NE, Mail Stop A-22
no amaa

 

2
202:0 

 

 

 

 

 

 

 

 

 

 

 

 

 

[b'jlf?'j

 

 

 

      
 

Dos?Egrioinnl reun?
2e2am: From-z  
Sent: Tuesday, April 24, 2012 3:14 PM
$3223?  
 Cc: minis: Him-t6": - 
- I  2  

 

 


Subject: Re: Meeting for April 25, 2012

uses
252mm 

 

 

045's 9 
 j: t.

 0 

 

"for your thoughtful consideration to our request. I will inform you of the specific details on tomorrow as

soon as they become known. Yourgratitude and partnership in this endeavor is appreciated. Goodnight for now!



0 am.

 

 

 

 


pril 24, 2012 06:20 PM

 

 

 

 

 

To.  


 

 

 

 

[b :1 
   

 

 

Subject: Re: Meeting for April 25, 2012



Wherewould v00 like to meet?

 

hl?nrr 
use. 4'33


I Sent: Tuesdav, April 24, 2012 04:03 PM


 

 

 

 

 

 

 

 

2
Accession Number: Specia191714 Page: 231

Sean Date:

2014-09-17 COPY

 

(blt?i: U.S.C. 
252m: 

Subject: Meeting for April 25, 2012

 

 

 

[Chili-42 
2:32th: ?ar-

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
of the BuildingVirvarium Tours. Again, my apology for the short notice, and thank you in advance for your support
and considerationls} to DSAT's requests.

PS: i am not in the office at this writing, this message is being sent via my BlackBerry. Feel free to respond at your
earliest convenience. Most 

Resnectfulh 
?31:23:24 
262:3?1

 

 

 

 

3
Accession NUmber: Specia191714 Page: 232 Sean Date: 2014?09?17 COPY

 

(bite!

 

PRIDSAT)

 

    

ib:~i3::42 sos

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   

 

 

 

 

 

 

262alh: tom: ..  
[mm Wednesdau An 25. 2012 9:33 AM
fbifgin:  I I [ma-42 0 
I . 232$?;  
     

Subject: RE: Meeting This Afternoon
ibi:[3::i4 
252mm  ..
(DRE:
and a few others have planned around this time. We will get

 

 

 

back with vou as soon as we can. Thanks.

 

?1:133:42 USE. 252mm

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE. Mailstop A45

Atlanta Ga 

?1:13:24 
2523ih

 

 

 

 

BSA Vision: To be the. preeminent resource ?or the srrfeigv and security nfbi'oiogicnt' ogwtis our! toxins.

This document is intended for the exciusive use of the recipienifs) named above. it may contain sensitive information that is protected. priviieged. or coniideniiai.
and it should not be disseminated. or copied to persons not authorized to receive such information. ifyou are not the intended recipientrs). any
dissemination. distribution. or copying is strictiy prohibited ifyou think you have received this document in error. piease notify the sender immediatehr and destroy
the original. Thank you

 

 

  

ear? Forte   -  
April 25.. 2012 9:22 AM



 

Sen
 



 

 

 



 

 

 

Is there any way we can have the meeting in Building 20. 3113 at 1:00 - 1:45 pm? We've had a request to change the
time due to schedule conflicts for some.

Thank you in advance.

 

2 
 

 

Centers for Disease Control and Prevention
Select Agent Compliance. Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22


Accession Number: Specia191714 Page: 233 Sean Date: 2014-09-17 COPY

Atlanta GA 1mm


 

2
2623!. T.

 

 

 

2
Accession Number: Specia191714 Page: 234 Scan Date: 2014-09?17 COPY

 

[bli?i

Dc T)

 

 

    



From:

Sent: A til 25. 2012 9:53 AM -
To: lcocrOPHPR/osan m.

 

 

 

 

 

 

 

 

 

 

m. ct: 
DCXD PH WDS (bits: 

Subject: FW: Meeting This Afternoon

I.



2U.S.2E2ai has Informed me to disregard the previous email request to change the meeting time. the meeting will remain as
previoustv scheduled. Thanks.

[01:23:24 
262301 

2 uses
252m;

 

 

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE. Mailstop A416

Atlanta. GA 30333

ib}[3}242 
262301 

 

 

 

 

DEA It" Vision: 109 be the resource for the safety and security ofbioingicni rigours tutti toxins.

This document is intended for the exciusive use of the recipientts) named above. it may contain sensitive information that is protected. privileged. or cortiidentiai.
and it shouid not be disseminated. distributed. or copied to persons not authorized to receive such information. it you are not the intended recipientis}. any
dissemination. distribution. or copying is strictty prohibited. it you think you have received this document in error. piease notify the sender tmrnediateiy and destroy
the originai. Thank you.

 

 

[13:13:14 uric.

 

   
  
 

 

 

 

 

 

 

 

 

 

 

2:32am:- From: 
I Sent: Wednesda April 25, 2012 9:33 AM
 i' '3 uses
 Cc 1 . J. (CDCIOPHPRIDSATJI  
i- i cocioPHPRiosnr}
Subject: RE: Meeting This Afternoon
[bli3 42 
2623 h} 
HIKE:
and a few others have planned around this time. We will get
back with vou as soon as we can. Thanks.

 

 

 

 

[h}t3} 42 
252m j:

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE. Mailstop 

1
Accession Number: Specia191714 Page: 235 Sean Date: 2014-09?17 COPY

 use.
252mm

Ariag'lta GA 30333

USA Vision: To be the preeminent resource ?ir the refreth and severity nfhiniogiml agent's nnrt' toxins.

This document is intended for the exclusive use of the recipient?t?S} named hoove. it may contain sensnive intorrnation that is protected. privileged, or ooniidentiet,
end it shoutd not be disseminated. distributed. or copied to persons not authorized to receive such information. lfyou are not the intended recipienrt's}, any
dissemination, distribution, or copying is Siritl?ly prohibited. it you thinir you have received this document in error. pteese notin the sender immediately and destroy
the angina-ti. Thank you.

 

 

Litedeejdey, Apri 25, 2012 9:22 AM
'26'2a?i'n: To "we 
Subject: Meeting This Afternoon

$5511? Ft??n  

 

 

 

 

 

 

 

 

Is there any way we can have the meeting in Building 20, 3113 at 1:00 1:45 pm? We?ve had a request to change the
time due to schedule conflicts for some.

Thank you in advance.

 


2B2ad. 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance. Rovbal Campus
1500 Clifton Road. NE. Mail Stop tit-22

ib?3?i2 
2623(?

 

 

 

 

2
Accession Number: Specia191714 Page: 236 Sean Date: 2014-09?17 COPY

 

 

 



[bh'?j


 

 

 

 

 

 

 

 

 

 

From:

Sent:

To: [bf-lb.

Cc: --


Subject: follow up to 4/25f2012 meeting

Based on our discussions yesterday, as part of our information collecting process, I would like
to request your help arranging interviews with the following people:

 

2) Dr Nathaniel Powell

3) 3-4 ARB workers that have duties in this 3?  a

4) the members of OSHE andfor BFO who participated in the most recent HVAC functional
testing of this lab (limit to 3-4 staff members from each). We do not need to interview
supervisors at this time.

 

 

 

 

We would like to meet with these individuals separately next week. If possible, we would like
to schedule 15-20 minute interviews in the early afternoon (1-230 pm) any day next week. Of
course, we will try to accommodate any schedule conflicts. Depending upon the final number
of individuals, we anticipate being able to finish by Wednesday. But should the need arise, we
can interview people later in the week. Please the names and proposed times

that these people can be available.

 

 

 

 

In addition, I would appreciate it greatly if you could provide me with the following
information/documentation;

1) the date when this lab was last tested for prOper airflow,

2) any documentation of this test,

3) the date when the lab was decontaminated prior to the reported airflow deviation,

4) any documentation regarding the decontamination procedures and verification of these
processes,

5) specific entry requirements for the suites when the labs are hot and cold,

6) specific entry requirements for the clean corridor areas outside of the lab suites

 
 

 



262a 

 

  

My apologies if you have already provided any of this information in the documents currently
under review.

1
Accession Number: Specia191714 Page: 237 Sean Date: 2014-09?17 COPY

We would also like to conduct a series of relatively simple tests of airflow patterns on this lab
and several others in the same general area next week. We propose to stand outside of the
containment space in the clean corridor with smoke sticks and verify the direction of airflow
while the inner door inside the containment space is opened and closed in the same manner
that caused the anomaly observed by the visitors. We are not requesting any failure scenario
testing, any HVAC system manipulations or any other mechanical procedures to be performed
during these tests. We will need someone from either ARB or OSHE to simply open and close
the inner door for various time intervals while we observe the smoke patterns from outside of
the lab area. These activities should provide useful information about the current status of the
ventilation system function.

If possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

 

[bili?

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention

1600 Clifton Rd NE Mailstop A 45
?nnroi: 

 

[bli?l

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

2
Accession Number: Specia191714 Page: 238 Sean Date: 2014-09-17 COPY

 



 



252mb;

 

PRIDSAT)

 

 



'26. 2012 159 PM
I?m sarcasm

  - licocw 
(cocroaH 

Re: follow up to 4f25f2012 meeting

 

 

      

n-i-n.

 

 

 

Subject:

Follow up
Completed

Follow Up Flag:
Flag Status:

 

 

 

Iibjii?j: I

 

We will be working to generate the information requested and will provide it as soon as possible.

 

 


Thursda Aril 26, 2012 06:40 PM
 ..
Subject: follow up to 4f25f2012 meetin

  
  

 

rs?

 
 

 

 

..

 

ICDCIOPHPRIDSAT),

 

Based on our discussions yesterday, as part of our information collecting process, I would like to
request your help arranging interviews with the following people:

 

 

 

 

 

 

 

 

1) 

2) Dr Nathaniel Powell

3) 3-4 ARB workers that have duties in this area

4) the members of OSHE and/or BFO who participated in the most recent functional

testing of this lab (limit to 3-4 staff members from each). We do not need to interview supervisors
at this time.

We would like to meet with these individuals separater next week. If possible, we would like to
schedule 15?20 minute interviews in the early afternoon (1-2:30 pm) any day next week. Of
course, we will try to accommodate any schedule conflicts. Depending upon the final number of
individuals, we anticipate being able to finish by Wednesday. But should the need arise, we can
interview people later in the week. Please send 9'3 the names and proposed times that
these people can be available.

 

1
Accession Number: Specia191714 Page: 239 Sean Date: 2014-09-17 COPY

in addition, I would appreciate it greatly if you could provide me with the following
information/documentation;

1) the date when this lab was last tested for proper airflow,

2) any documentation of this test,

3) the date when the lab was decontaminated prior to the reported airflow deviation,

4) any documentation regarding the decontamination procedures and verification of these

processes,

 

[b18142

 

 

 

5) specific entry requirements for theEssz?'n? suites when the labs are hot and cold,
6) specific entry requirements for the clean corridor areas outside of the lab suites

My apologies if you have already provided any of this information in the documents currently
under review.

We would also like to conduct a series of relatively simple tests ofairflow patterns on this lab and
several others in the same general area next week. We propose to stand outside of the
containment space in the clean corridor with smoke sticks and verify the direction of airflow while
the inner door inside the containment space is opened and closed in the same manner that
caused the anomaly observed by the visitors. We are not requesting any failure scenario testing,
any HVAC system manipulations or any other mechanical procedures to be performed during
these tests. We will need someone from either ARB or OSHE to simply open and close the inner
door for various time intervals while we observe the smoke patterns from outside of the lab area.
These activities should provide useful information about the current status of the ventilation
system function.

If possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

 



 

031033

 

- miss:
Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46
Atlanta. Georgia 30333

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

2
Accession Number: Special91714 Page: 240 Sean Date: 2014-09?17 COPY

 



 

 

 

 

 

 

 

 

 

 

 

 

  

  
    

 

(CDCIOPHPRIDSAT)

was:
From: . 
Sent: ,Aril 30, 2012 3:48 PM
To: . 
Cc:  
Subject: Interviews


Please see below for the interview schedule for this week's interviews.
[bli?i
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:00 am. Individual: Dr. Nathaniel Powell
Tuesd May 1 Location: Building 24, Room 11-101A Time: 10:30 am. Individual: 
[ti-?3533?
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 11:00 am. Individual:
(use:
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 11:30 am. Individual:

 

 

 

M6: is currently on leave ofabsence through June 2012 and has specificallyr and persona?? ?3 her

line management in DSR that she does not wish to discuss matters related to the Building' 

- v, May 2 Location: Building 20, Room 2111

  

 

Wednesday, May 2

Thursday, May 3
Thursday, May 3

Location: Building 20, Room 2111

Location: To Be Provided
Location: To Be Provided

acility with anyone.

 

 

 

 

 

 

 

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members OSHE,

BFO and the office will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 



:42 

01.

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333
:42 uses
..

 

03213
2023

 

 

 

 

1
Accession Number: Specia191714 Page: 24

[0:133:42 Ll. 


Time: 1:00 p.m. Individual: 

Time: 1:30 pm. Individual:
[bli?l

Time: 9:00 a.m.lndividua :

Time: 9:30a.m.lndividual:

1 Scan Date: 2014-09?17 COPY

 

 

. ..   

 

 

 

From: 

Sent:  30. 2012 4:41 PM

To: (cocxompwosan [my

Cc: IW licocxompexosm 
Subject RE: Interviews

Let?s meet about 0915 tomorrow to discuss these interviews

 

[1:30:03

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention

1600 Clifton Rd NE Mailstop A 46
?rl-Inn-l': ?aunt-oi: 111122

 



 

 

 

DSAT Vision: To be the preeminent resource for the safety and security.' of biological agents and toxins.

 

 

tail-ii? 

   
  

 

 

 

 

 Se 30, 2012 4:33 PM 
stair-Eta. bum 
(CDCIOPHPRIDSAI "i 

 

 

 

S??ject: RE: Interviews

 

 

l2 
2523i 3 

 

 

 

Thank you for your devoted appreciation and attention to putting together the interview schedules and related activities
as denoted below. This email acknowiedges receipt of said noticefdocument and our gratitude for your support. Again,
thank you.

 

 

 



 



2012 3:40 Pew .


(CDCIOPHPFUDSAT)

 

 

 

 

 

 

 

   

 

[b36142 
Good Afternoon 252301;:

 

 

 

1
Accession Number: Specia191714 Page: 243 Sean Date: 2014-09-17 COPY

Please see below for the interview schedule for this week's interviews.

 

ibii?';
Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:00 a.m. Individual: Dr. Nathaniel Povvell
Tuesday, May 1 Location: Building 24, Room 11-10IA Time: 10:30 a.m. Individual: 
(use:
TUesday, May 1 Location: Building 24, Room Time: 11:00 a.m. Individual:
(has:
Tuesday, May 1 Location: Building 24, Room 11-1014 Time: 11:30 a.m. Individual:

 

 

 

[b :03 

 

is currently on leave of absence through June 2012 and has specifically ini personally conveyed Lb, 3:142 
line management In DSR that she does not wish to discuss matters related to the Budding 

 

 

 

 

 

 

 

 

 

03:16:-
Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:00 pm. Individual:
tune;
Wednesd y, May 2 Location: Building 20, Room 2111 Time: 1:30 pm. Individual:
03:10:-
Thursday, May 3 Location: To Be Provided Time: 9:00 a.m.lndividual: 
Thursday, May 3 Location: To Be Provided Time: 9:30 a.m.lndividual:

 

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 a.m. Members of ARB, OSHE,
BFO and the office will be available to assist:

Other documentation that was requested in your e-mail of April 25 is forthcoming.

Sincerely,

 

2 uses
252m 3:    

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333
[bl-i3 :42 
2522b: 

 

 

 

 

2
Accession Number: Page: 244 Sean Date: 2014-09-17 COPY

 

 

ibii?';
I 

  
   
   

 

 

 

 

 

  

 

 

 

 

 

From: ?ii-3342 
Sent: ednesda May 02, 2012 3:05.0. 2u2aih. I 

Subject: Requested Documentation
toil
Per your request of April 26, 2012, the following dDCumentation is provided with this submission:

1} The date when this was last tested for proper airflow bv BFO was December 21, 2011. OSHE

 

 

 

verified proper airflow on January 9, 2012.
2] Any documentation ofthe first two ?pdf? attachments are provided by the third 'pdf? is the OSHE
verification of airflow on January 9, 2012

  

. Vivarium
- 42012.pdf

 

   

3) The date when the lab was decontaminated prior to the reported airflow deviation (December 5, 2011 using
Spor-Klenz). The OSHE procedures for Spor-Klenz decontamination are provided below.

 

LABORATORY
SURFACE 

[0'13?112

 

The specific entry requirements for thufgjej 2 suites when the labs are hot and cold as well as for the clean corridor
areas outside ofthe lab suites will be forwarded under separate cover later this afternoon.

Best reeards
U.S.C. 262301;:

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Step A-22

Atlanta. GA 30333

[0133242 U.S.C. 252301]

 

 

 

 

Accession Number: Specia191714 Page: 245 Sean Date: 2014-09?17 COPY

 

[bli?i

 

 

 

 

 

 
  
 

 

 

   
 

 

 

 

   
   
  

 

 

 

 

 

From (CDCIOPHPRIDSAT)

Sent May 02, 2012 5:03 PM

To: cocrosesitsmpoy 

Cc: tcocxoPHP__ titties. -
It 
is?


Subject: RE: Requested Documentation

.
252aih; mtg-"42

  

Thanks once again for your valuable assistance and ieadership in identifying kev partners in collecting this beneficial
information. We look forward to your continued support toward the completion of this significant project. Also, a
priceless thank you to the men and women whom we have interviewed thus far, as well as those waiting to be
interviewed.

 

U.S.C. 252301}

 

 

 

03133142 U.S.C. 252301]

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A416

Atlanta, GA 30333

[miajx 2 uses
262301   ..

 

 

 

 

DEA Vision: To be the preeminent resource for the safety and security of hioiogicrti agents and toxins.

This document is intended for the exotusive use of the recipienttsi named above. it may contain sensitive information that is protected, priviieged. or oonfideniiei,
and it shouid not be disseminated. distributed. or copied to persons not authorized to receive such information. it you are not the intended reoipientfs), any
dissemination, distribution, or copying is striotiy prohibited. if you thinir you have resented this document in error. pieese notify the sender immediateiy and destroy
the originai. Thank you.

 

  
 
  

 

 
 
   
   
 

 

 

 
    

 

 

 

  

 

 
    
 

 

 

 

From ?Jig-??2 
[nutmeg y, May 2012 3:1  
-- 
. 

      



Subject: Requested Documentation

 

[hint-:42 
252aihj

 

 

 

Per your request of April 26. 2012, the following documentation is provided with this submission:

1
Accession Number: Specia191714 Page: 247 Sean Date: 2014-09?17 COPY

(0:63:42 

252m??- was last tested for proper air?ow bv BFD was December 21, 2011. DSHE
verified proper air?ow on January 9, 2012.
2) Any documentation of the first two 'pdf? attachments are provided bv the third ?pdf? is the OSHE
verification of air?ow on January 9, 2012

(-2: File: Vivarium Dec 11 

3) The date when the lab was decontaminated prior to the reported airflow deviation (December 5, 2011 using
Spor-Klenz). The OSHE procedures for Spor-Klenz decontamination are provided below.

File: LABORATORY SURFACE DE I NTAMINATION UP WITH 
. . 
252mm ?153-4 suites when the labs are hot and cold as well as for the clean corridor
areas outside ofthe lab suites will be forwarded under separate cover later this afternoon.

 

Best regards.
U.S.C. 252mb}

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1500 Clifton Road, NE, Mail Stop A-22
Atlanta. GA 30333

[eta-:42 use. 2's2aihj:

 

 

 

 

2
Accession Number: Specia191714 Page: 248 Sean Date: 2014?09?17 COPY

 

(CDCIOPH PRIDSAT)

 

  
 

[bi-?34? 
Thursda May 03, mu AM
{coo/oPHPR/osan

CDCKOPHP

raj;i3j::42 us. . 

    

 

 

 

 

Powell, Nathaniel 

 

 

 

 

 

 

 

 

Subject: FW: DSAT Information

2E2aih}

As promised, please find Bldigeg??h? Vivarium entry requirements provided below per Dr. Nathaniel Powell.
Sincerelv.

 

[13:13:42 U30. 252aih}

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A22
Atlanta, GA 30333

[13:13:42 USC. 252mm

 

 

 

 

 

From: Powell, Nathaniel (CDCIOIDINCEZID)
I I Sent: aa- -. May 02, 2012 3:51 PM
gig-25ers: i' 
Subject: DSAT Information

lam providing the following information as requested. Please let me know if you need additional information.

  
  
 

 


2E2al

 

 

. . . [b36142 
Question: Specufic entrv requrrements for the uses surtes when the labs are hot

nan 

 

 

 



. .
252mm when the labs are hot are dependent on studies conducted in the
specific room. The following information is provided:

 

 

 

 

 

 
 

[13:13:42 

2523i?? Tvvek suit, PAPR with head caver bonnet, 2 pairs of gloves, inner shoe covers,
outer shoes

uses  [mm . . . .

252mm  When the are hot: accmatlon reqmred for entry, Tvvek PAPR

 

 

 

 

with head cover bonnet, outer shoe cover, inner shoe cover, 2 pairs of gloves, second outer smock when
handling animals, facility shoes

1
Accession Number: Specia191714 Page; 249 Sean Date: 2014-09?17 COPY

 

U.S.C. 252: 1 
I test, Tyyek surt, PAPR with head cover bonnet, inner shoe covers, outer shoe covers, facility

shoes

0 Note: Rooms do not currently contain animals. Specific entry requirements will be protocol
driven. [Rabies vaccination is required when suite assigned to Rabies Program is hot.)

I Clean corridor - No PPE is required in this area

 

 

 

 

 


. . . USE. .
Question: Specific entry requrrements for the 252m? surtes when the labs are cold

 

 

 

 

m:r3::42
Response: Entry requirements for the suites when the labs are cold include the following:

OR'Dmhi

 

 

 

- Completion of the Personnel Sign In Log
0 access or escort by ARES personnel

Specific entry requirements for the clean corridor areas outside ofthe lab suites
Response: Entry requirements for the clean corridor outside of the labs suites include the following:

1- Completion of the Personnel Sign In Log
I: access or escort by ARB personnel

2
Accession Number: Specia191714 Page: 250 Sean Date: 2014?09?17 COPY

 

mus: PRIDSAT) 

 

 

 

 

(bits:
From: 

Sent: Monda June 25 2012 8:08 PM

To: 

Whit-?Ct: Fw: Facility assessment of W142
Attachments: Assessment of the Registered Building docx

 

 

 

 

'bihere IS a summary which I prewously prowded to Dr. Weyaot before the reporter 5 article was published. call

you tomorrow.
ibifi?i:

 

 

 

 

Sent using BlackberrY

?Jim? 
Sent: Thursday, June 07, 2012 01:3? ME:
To: Weyant, Rob (CDCIOPHPRIDSAU

Subject: Facility assessment of vivarium

 

 

 

 

 

 

[n13:42
?Assessment of the Registered Bonding Essa-Cg .docx>>

 

 

 

1
Accession Number: Special91714 Page: 251 Sean Date: 2014-09?17 COPY

 

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252mm

 

 

Facility Assessment of the Registered Building Vivarium Space

 

 

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facilities.

 

HVAC modifications to the Building 1: vivarium meet BMBL criteria lo

42'

 

 

 

- The airflow reversal incident was transient, and the mechanical problem has been corrected.

  

anc Modifications to Buildin . ii:

  

Lbji3j-142 uses 
The Buuldin2azain; vivarium is a muItI-room containment block surrounded by a ?clean? (non-containment)

outer corridor. Entrance to the containment suites is ordinarily via each suite's anteroom from the clean
corridor, and Exit is into the Icorridor. The original airflow design ofthe vivarium was
for the air to flow from the animal suite holding rooms into the inner corridor. A decision was made in early
2010 to reverse the airflow of the inner corridor so that the air would flow from this corridor into the animal
suite holding rooms. This airflow change was in strict agreement with the EMS [$3225 wording: ?The direction

of airflow into the animal facility is inward; animal rooms maintain inward directional airflow compared to

 

 

adjoining hallways."

The original airflow of the inner corridor was also acceptable from a secondary containment perspective,
because air flowed inward from the clean outer corridor into the animal suite anterooms and from there into
the inner corridor. Personnel entering these areas are wearing respiratory protection and are showering prior to
Exiting cantainment. The wording of the BMBL on directional airflow does not in general address the various
possible airflow configurations of multi-room containment blocks.

At the time of the original proposal to change the inner corridor airflow, concerns were raised by facility
personnel about a lack of anterooms between the inner corridor and each animal suite..0ne concern was that
airflow disturbances could result when the doors from animal holding rooms to the inner corridor are opened.
The BM BL states foareas:  Facilities should be re-veri?ed at least an modified by
operational experience." Experience would confirm whether airflow disturbances result from opening the inner
corridor doors. and is not aware of this problem occurring. Another concern was the possible entry by
personnel into another animal suite from the inner corridor after exiting an adjacent suite, which may be
construed as not being in agreement with the BMBmording: "Entry into the containment area is via a

 

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Accession Number:

 

 

The results of HVAC verification tests for the vivariu m, which were performed after the inner corridor airflow
modification was completed, were provided by CDC to the CDCIDSAT office, confirming that during the failure of
single exhaust fans or during a normal power failurefrestart simulation, there was no reversal ofairflow from
potentially contaminated areas into clean areas outside of containment. Exhaust fan failure testing was
performed in December 2010, and the power failurefresta rt simulation test was performed in December 2011.

Specia191714 Page: 252 Sean Date: 2014?09?17 COPY

Airflow Reversal Incidem

On February 16, 2012, an airflow reversal into the outer vivarium corridor was noted during a tour of the
vivarium by visiting inspectors from the Department of Defense. The visitors in the outer corridor felt a puff of
air from the  procedure room when a laboratorian entered this room from the inner animal holding
room, and the connecting door between the two containment rooms swung closed. The procedure rooms, in
addition to anterooms, have doors which open directly to the outer corridor which are used to bring clean cages
into the Suites. These containment boundary doors are equipped with a window and an opening in the window
frame that allows air to flow into the inner laboratory when the ventilation system is operating properly.

 

An internal investigation of the cause of the airflow reversal determined that the inner door was closing too
swiftly, resulting in a piston-like effect and a puff of air at the outer door window frame opening. InSpectors
from the CDCIDSAT office visited the vivarium on May 3, 2012 after the inner door closer was adjusted and used
smokesticks to observe the airflow at the containment boundary doors leading directly into the animal suite
procedure rooms. One or more laboratorians sequentially entered multiple suites to open the inner connecting
doors while the inspectors made airflow observations in the outer corridor at the boundary door windows. No
airflow reversals were observed during any ofthe tests performed. The mechanical problem that caused the
transient airflow reversal had been corrected, and the HVAC system serving the vivarium was verified by the
inspectors to function properly to maintain inward directional airflow under normal conditions.

Accession Number: Specia191714 Page: 253 Sean Date: 2014?09?17 COPY

 

[bii?l



 

(DRE:

 

  

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 --      
Attachments: 
Importance: High

See attached.

 

mild: ibii?}

 

 

 

 

I am going to the 3:00pm meeting regarding this 

 

Dr. Weyant wants all documents by Friday. Can you give me a call to other than the What about your
emails, drafts, etc since you are out on inspection?

 

Ilbli?i:

 

 

Division of Seiecr Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS 
[mar ?it-Innf: no 31112:

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated, distributed. or copied. If you think you have received this document in error, please notify the sender immediately and destroy the
original, thankyou.

1
Accession Number: Page: 254 Sean Date: 2014-09-17 COPY

 

  

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[0:133:42 

  

252mm  3y I 3; 
I Sent: Tuesda June 26 2012 3:13 PM

5?:me  .  -. 

cg;  

Subject: CDC Form 3 Summa 
Attachments: CDC Summary Forpdf

 



 

 

 

 

Summary of CDC Form 35 are attached.

 

uses
[0:33:24 
2523f? 

 

 

 

 

 

 

inert, Loss and Helease Loordinator

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE M5 A416

Atlanta. GA 30333

uses
252mm

 

 

 

 

 



DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If vou are not the
intended recipient, anv dissemination, distribution, or copving is strictlv prohibited. If vou think vou have received this document in error, please
notify the sender immediateiv and destrov the original. Thank v0u.

1
Accession Number: Specia191714 Page: 255 Sean Date: 2014-09?17 COPY

 

Form 3, Report of Theft, Loss and Release
DATA FILE PAGE

1'va of
Report

Report Date Year

I 
Emma Name City State Entin Type Select Agentfhuln Elma [mawa Risk Assassment

Level

 

 

 

 

Controlled Unclassified Information
Printed 61'25f201 2 313109 PM {formerly Sensilive But Unclassified) Page 1 Di 2

Accession Number: Specia191714 Page: 256 Scan Date: 2014-09?17 COPY

APHISICDC Form 3, Report of Theft, Loss and Release
DATA FILE PAGE

Report

I aaf . .
Report Date Year "a City Entity Type Select Agentf?lbxin amgf?v Elmawa Risk Assessment

 

Type LEHEI

US. 525mm:

Controlled Unclassified Intermatiun
Printed eras-r2012 at 3:09 PM [forme?y Senettive But Unclassified) Page 2 0f 2

Accession Number: Specia1917l4 Page: 257 Scan Date: 2014?09?17 COPY

 

 



  
 

(CDCIOPH PRIDSAT)

 

 

 

 

 

 

 

[mixes uses
Sent: Tuesdav, June 26. 2012 4:53 PM
?33?5" To: I 
Cc: I 
Subject: Form 35 Building
Attachments: CDC 013003 Form 3.pdf; CDC 013112 Form 3.pdf: CDC 022410 Form 3.pdf; CDC 051911



Form 3.pdf; CDC 05250? Form 3.pdf

Hi.

I pulled up all the archived scans for CDC. Attached are the ones submitted that involve  

lfvou need additional information, let me know.

 


252mm

 

 

 

Theft, Loss and Release Coordinator

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A-46

Atlanta, GA 30333

 


2523il?i

 



 

 

 

Accession Number:



DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

[0:13:42 


This document is intended for the exclusive use of the recipient named above. It mav contain sensitive information that is protected, privileged, or

confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If vou are not the
intended recipient, anv dissemination, distribution, or copying is prohibited. If vou think vou have received this document in error, please

notifv the sender immediater a nd destroy the original. Thank you.

Specia191714

1
Page: 258 Sean Date: 2014-09?17

COPY

 

 

 

 

 

 

 

 

 

 
 
  

 

 

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ib}i3}:42 uses 
2523?? From:  
[not Sent: 7, 2012 12:10 AM

Cc: rcocxow 
Subject:

Attachments: Form 3 List with 
[bli??

 

 

 

in:
Re-verified the list one more time. Attached is the Building ntries highlighted in red. The Form 35 were sent this
?39353? an pull those files, copy and make duplica iles from the original files. Wish I was there to lend a
hand.

 

Time to get some sleep, it has been a long day. This place is in the middle on nowhere.

 


2523M: Best,  


[b11313 2 
262ml 2   ..

 

 

 

 

 

 

 

Theft, Loss and Release Coordinator

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS aft?46

Atlanta, GA 30333

1119:3342 uses
262al 

 

 

 

 

 



DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the
intended recipient, any dissemination, distribution, or copying is strictly prohibited. if you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Special91714 Page: 259 Sean Date: 2014-09?17 COPY



a?ed

=anea Hess 093

LI-GO-FIOZ



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APHISICDC Form 3, Report of Theft, Loss and Release
DATA FILE PAGE


?a a State 

Rep-art

Biosa lehr
Type

Einsafety
isvel

Re you Date ?fear fn'li'ly Time Select Agenthanin Risk Assessment

Emir}; Marne City

 

 

 

 

Controlled Unclassified Informatien

Printed 2 at 12:01 AM [formerly Sensitive But Unclassified}

Page 1 of 2

 Form 3, Report of Theft, Loss and Release
DATA FILE PAGE

of I 51":me Einsafet .
?ip or: i Ell? Entity Tym- SEIECI 1' gasesm?m


Report Dam: Year

Type 

 

U. .0. 252mm

 

Controlled Unclassified lnlormalion
Printed 6:27:2012 at 12:01 AM {tormeny Sensitive But Unciassified) Page 2 of 2

Accession Number: Specia191714 Page: 261 Scan Date: 2014?09-17 COPY

 

['13 HS 



ibl?i?i

 

-  (CTR)
Wednesday, June 2012 2:55 AM


[bl-[53

RE: Form 3 List

 

 

 

 

 

 

 

 

 

 

 

  
  

 

 

 

     

wire:
I will pull and copy the files listed.
See you when you get here.
[bl-i5} - 
From? ?53 
mm, Sen ne 2012 7:02 AM
QB: To! ?3?57- DCIOPHPRIDSAT) (CTR)
c; we?  (CDCIOPHPRIDSAT)
Subject: Fw: Form 3 List

The outcome of the meeting yesterday is that we need to make a duplicate Form 3 file for each of the cases that
 pulled the files and they are highlighted in the attachment. Can you pull these files out

please? We will need 5 red folders too. I will be in later today. Around 1pm to help copy. Also, can you help with a

related project tomorrow? I have to copy and collated paperwork related to facilities reviews.

See you later today.

Thanks

 

ibiiB:

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE M5 ill-46

Atlanta, GA 30333

fbli?? I I

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, priviIEged, or confidential, and it
should not be disseminated, distributed, or copied. it you think you have received this document in error, please notify the sender immediately and destroy the
original, thank you.

 

 

 

 

 

 

 

intuit-:42 
-- 
WE, Salamander?144m 2012 12:10 AM
To: 
-   

 

 

Subject: Form 3 List

 

[13:16}

 

 

Hi, 

 

1
Accession Number: Specia191714 Page: 262 Sean Date: 2014-09-17 COPY

Re-verified the list one more time. Attached is the Building entries highlighted in red. The Form 35 were sent this

m; pull those files, copy and make duplicate files from the original files. Wish I was there to lend a
hand.

Time to get some sleep, it has been a long dav. This place is in the middle on nowhere.

 

uses
2523th  
.I

ibliS}: 2 uses

 

 

 

 

 

 

Theft, Loss and Release Coordinator

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A-46

uses
2?2aih

 

 

 

 



DSAT Vision: To be the preeminent resource for the safety and securitv of biological agents and toxins.

This document is intended for the exclusive use ofthe recipient named above. It may contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the
intended recipient, anv dissemination, distribution, or copving is stricth prohibited. If you think you have received this document in error, please
notifv the sender immediater and destroy the original. Thank vou.

2
Accession Number: Specia191714 Page: 263 Sean Date: 2014?09?17 COPY

 

 

 

 

tbtt?';   

 

 

  

 

 

   
  
  

    

 

 

 





From: 

Sent Joe 27. 2012 9:01 AM

To: 

Ce: 

Subject: Re: ACTION: Notes in response to inquiry

thaue already sent my notes and fites to
tbl?tBi a

From:- CDCIOPHPRIDSAT)
I Sent: Wednesda June 2012 08:48 AM I I. 
the? m; -- 

 I 
Cc: 
Su eject: ACTION: Notes in response to inquiry

 

All 
Please see the attached list. You all have been a part of inspections of CDC ATL since the lf'lf2005?

present timet?rame for the congressional inquiry. Dr. Weyanl would like us to have our information together by

this Friday, and that needs to include any no pg?gort the inspections, meeting notes about tlte

it .1'3

inspections, meeting notes about safety issues in the use we labs of Bldg.(only 3 and 
fire safety for some reason), and any personal notes you might have taken in regard to the same.

 

 

 

 

I know you all are out this week, so if you can point me to where they might be stored lid be happy to
collect them, but I know that may not work. Can you please respond positively to this message with a set of
actions that can take to try to accommodate Dr. Weyant?s timeline. even it' that is just "wait until I'm back
because they?re too scattered to be collected by anyone else?. Also, please respond it? yoa have no such notes,
or if they are all included in the inspection folders and you have nothing further to contribute to the collection.

The deadline for CDC to respond is W6. The letter is in the USA today story I?m hesitant to send my
copy in an email that may be read on a non-CDC computer for no good reason other than fear and uncertainty,
but I?m happy to point you to the copy you could access the same as any member ofthe public.

 I ?5

  

 

[Cutot Scope] I

 




 

[bil?]

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

Atlanta, GA 30333

 

teas;

 

 

 


Accession Number: Specia191714 Page: 264 Sean Date: 2014?09?17 COPY

 



 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

2
Accession Number: Page: 265 Sean Date: 2014-09-17 COPY

 

 

Subject:

 



 

Weyant, Rob 
Wednesda June 27, 2012 9:06 AM
-
lcocroeapwosan;
Blaine, James 


FW: Timeline

 

  

 

 
  

 

 

 

Good morning folks,

Please see below and attached.

 

 

 

 

    
  

    

 



fety

could you please plug in the dates of the various DSAT inspections.

 

 

 

 

 

cauld you please provide with dates of any additional inspections, investigations, or site visits that the Biosa
Team did at Building during this time.

 ., . mite: . . . . ..
please send me, Dr. Blame, the timeline with our activities when completed.

Many thanks,

Rob Weyant

Rohhin 5
Captain,

Director,
Office of

. Weyant, 

USPHS (Rem

Division of Select Agents and Toxins
Public Health Preparedness and Response

Centers [or Disease Control and Prevention
Of?ce phone: 4tt4-7'18-20tjl

Cell phoi
SiprNet:

to: 6?8-614-?284

'satzll?J 'ric .dia.smil.mil

 

BEAT Vision: To be the preerninent resource for the safety and security of bioiogicoi agents and toxins.

This document is intended for the exclusive use of the recipient{s) named above. It may contain sensitive information that is

protected
Such info

privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
rmation. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. If you

think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

From: Henderson, Joseph (CDCIOCOOJOSEP)

Sent: Wednesday, June 2012 8:34 AM

To: Weyant, Rob Meechan, Paul J. 
Subject: Fw: Timeline

Roo,on

this timeline can you add when DSAT was called into conduct inspections especiatly following the event this

past February. Just trying to get all of our actions on this timeline. Let me know it we need to discuss. Joe

Joseph
Director,
Lead for

M. Henderson
Office of Security and Emergency Preparedness 
the Consoiidation of of Sustainabilityano' the Logistics Management Branch in P60.

1
Accession Number: Specia191714 Page: 266 Sean Date: 2014-09?17 COPY

Centers for Disease Centre! and Prevention (CDC)
U. S. Department of Health and Human Services

404-639-7 13 1
Consolidation of OSHE, BFO, OSEP, the Office of Sustainability and P605 Logistics Management Branch

 

From: Daniel, Katherine Lyon 

Sent: Tuesday, June 26, 2012 12:20 PM

To: Frieden, Thomas (Torn) Arias, Ileana Villar, Carmen S. (CDCIODJOCS)

Cc: Hunter, Edward L. Henderson, Joseph Reynolds, Barbara S. (CDCIODIOADC)
Subject: Fw: Timeline

As requested. I?m not sure of current status and use, but think it would be useful to post wf other info.

i

Timeiine -
Butt-ding 6 '26 

Katherine Lyon Daniel, 



2 
Accession NUmber: Specia191714 Page: 267 Sean Date: 2014-09?17 COPY

mn?l



 



 

 

 

 

 


From: 
Sent:
To:
Subject: RE: Timeline

   

(?165* to check completeness of any unofficial visits.
Thanks

 

 



 

 

 

was:

 


- --
262alh':

Lead

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

Atlanta, GA 30333

 

 

 

 

I Subject: Fw: Timeline

 

2012 9:08 AM

Wednesda June 27,
 

sent me a timeline to contact all inspectors for notes, so I?ll do this and send back to you all for



DSAT Vision: To be the preeminent resource for the safer and security of biological agenls and toxins.

 

From: Weyant, Rob 
Sent: Wednesda June 27, 2012 9:05 AM




 

Good morning folks,

 

[ba3s42

 



this time.

. Accession Number:

 

please send me, 

Many thanks,

 

Rob Weyant

Specia191714

could you please plug in the dates of the various DSAT inspections. -  
with dates of any additional inspections, investigations. or site visits that the Eiiosal?t-ityr

Page:

  
 
 
  

(CDCIOPHPF -

 

 

(cocioenpwosar); I

  

the timeline with our activities when completed.

1

268 Sean Date: 2014-09-17 COPY

Robbin S. chant, REHABSA)

Captain, USPHS 

Director, Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Office phone: 404-718-2001

Cell phone: 678-614-7384

SiprNet: jsatziJEiganricp.dia.smil.mil

DSAT Vision: To be the preeminent resource for the safety and security ofhioiogicoi agents and toxins.

This document is intended for the exclusive use of the recipiem{s) named above. It may contain sensitive information that is
protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

From: Henderson, Joseph 

Sent: Wednesday, June 2012 8:34 AM

To: Weyant, Rob Meechan, Paul J. 
Subject: FW: Timeline

Rob, on this timeline can you add when DSAT was called into conduct inspections especiallyr following the event this
past February. Just trying to get all of our actions on this timeline. Let me know if we need to discuss. Joe

Joseph M. Henderson

Director, Office of Security and Emergency Preparedness 

Lead tor the Consoiidation of DSHE, BFO, DSE P, Office of and the Logistics Management Branch in PGD.
Centers for Disease Controt and Prevention (CDC)

U. S. Department of Heaith and Human Services

404-639-7131 I

Consoiio?otion of OSHE, BFD, DEEP, the Office of and Logistics Managemem Brunch

 

From: Daniel, Katherine Lyon 

Sent: Tuesday, June 26, 2012 12:20 PM

To: Frieden, Thomas {Tom} Arias, Ileana Villar, Carmen S. 

Cc: HuntEr, Edward L. Henderson, Joseph Reynolds, Barbara S. 
Subject: FW: Timeline

As requested. I'm not Sure of current status and use, but think it would be useful to post w! other info.

6 26 12.doc:t 

Katherine Lyon Daniel, 



2
Accession Number: Specia191714 Page: 269 Sean Date: 2014-09-17 COPY

 

inns;   PH PRIDSAT)

 

 

 

 

 


Sent: Wednesda June 27, 2012 9:19 AM 1115..
To: 
Subject: RE: Time-line

4. ,1 

2528??: list
Thanks

one;
.

?rm

   

Timeline -

 

 

 

 

 

 

 

 

   

 

 

Building 


I [bli?i I

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response

Centers for Disease Control and Prevention

1600 Clifton Road NE MS xii-46

Atlanta, GA 30333
[bl't?i

DSAT Vision: To be the preeminent resource for the safer and security of biological agents and toxins.
HIKE:

 

Flinm: 

 Ewe 27, 2012 9:08 AM
I 

Subject: RE: Timeline

 

 

  

to check completeness of any unofficial visits.
Than t;

 

[thsz

 

 

 

 

 

[bit?i 
I I

1
Accession Number: Specia191714 Page: 270 Sean Date: 2014-09?17 COPY

traits:

ibiisjz.
lbiial
iBiiEi

Division of Select Agents and Toxins

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A416

Atlanta, GA 30333

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.
From: Weyant, Rob (CDCIOPHPRIDSAT)
Sent: Wednesda June 27, 2012 9:06 AM
Tet. tcocroenp m,
rr-  :encio  -- W1 cocroriHPRrosAT);  
 ..(cosineneetassoc (encroenproosnr)
Subject: FW: Timeline
Good morning foiks,
. . .  - see
Please see beiow and attached. ?ill-?r lcould you please plug In the dates ofthe various DSAT inspections. E.

 

 

could you please providelmil?i .with dates ofany additional inspections, investigations, or site visits that the Biosafety
Team did at Building during this time.

please send mew?:

Many thanks,

 

I the timeline with our activities when completed.

Rob Weyant

Robbin S. Weyant, 

Captain, USPHS (REL)

Director, Division of Select Agents and Toxins
Office of Public lifealth Preparedness and Response
Centers for Disease Control and Prevention

Office phone: 404-318-2001

 

DSAT Vision: To be the preeminent resource for the safety and SECurr'ty of biologicoi agents and toxins.

This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that is
protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

From: Henderson, Joseph (CDCIOCOOIOSEP)
Sent: Wednesday, June 2012 8:34 AM

2 
Accession Number: Page: 271 Sean Date: 2014-09-17 COPY

To: Weyant, Rob Meechan, Paul J. 
Subject: FW: Timeline

Flob, on this timeline can you add when DSAT was called into conduct inspections especially following the event this
past February. Just trying to get alt of our actions on this timeline. Let me know if we need to discuss. Joe

Joseph M. Henderson

Director, Dttice of Security and Emergency Preparedness a

Lead for the Consolidation of OSHE. BF O, 085 P, Otiice of the Logistics Management Branch in PGO.
Centers for Disease Controi and Prevention (CDC)

U. S. Department of Heaith and Human Services

404-639-7131

Consoiidction EFD, DEEP, the Office and tooistics Monooement Branch

 

From: Daniel, Katherine Lyon 

Sent: Tuesday, June 26, 2012 12:20 PM

To: Frieden, Thomas {Tom} Arias, Ileana Villar, Carmen S. 

Cc: Hunter, Edward L. Henderson, Joseph Reynolds, Barbara S. 
Subject: Fw: Timeline

As requested. I'm not sure of current status and use, but think it would be useful to post w! other info.

cc: File: Timeline - Building 6 26 

Katherine Lyon Daniel, 


3 .
Accession Number: Specia191714 Page: 272 Sean Date: 2014-09?17 COPY

 

 



From: 

 

 

 

 

 

 

 

 

 

Sent: Wednesday, June 27, 2012 9:38 AM

To: this? licocxoeupwosnn 

Cc: Weyant, Rob ..icocxoeaesttl?elt_ 


Subject: FW: Timeline


2623[l'i}

 

 to the timeline provided from Centers. Can you send me a list or add to this
I performed by the Form 3 group?

Thank vou,

 

Timeline -

uses

 

 
 

 

From: Wevant, Rob 
Sent: Wednesday, June 2012 9:ibiie: (CDCIOPHPRIDSAT) I I PRIDSAT)

 

 



  
   

        

 

 



      

 

Good morning folks,

 

  

[bit?i

Please see below and attached. could you please plug in the dates of the various DSAT inspections.

I could you please provide ith dates ofanv additional inspections, investigations, or site visits that the Biosa ety-
this time.

 

 

lbilplease send me,  Ithe timeline With our activities when completed.

Many thanks,

Rob Weyant

Robbin S. Weyanl, REHABSA)
Captain, USFHS (Rec)
Director, Division of Select Agents and Toxins
Office of Public Health Preparedness and ResponSe
Centers for Disease Control and Prevention

Office phone: Mid-7139001
Cellphone: 
SiprNet: 'satz?gt 'ric .dia.smil.mil

 

DSAT Vision: To be the preeminent resource for the safety and security of bioiogicoi agents and toxins.

1
Accession Number: Specia191714 Page: 273 Sean Date: 2014-09-17 COPY

This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

From: Henderson, Joseph 

Sent: Wednesday, June 2012 8:34 AM

To: Weyant, Rob Meechan, Paul J. (CDCIOCOOIOSHE)
Subject: FW: Timeline

Flob, on this timeline can you add when DSAT was called into conduct inspections especially following the event this
past February. Just trying to get all of our actions on this timeline. Let me know if we need to discuss. Joe

Joseph M. Henderson

Director, Office of Security and Emergency Preparedness 3:

Lead for the Consoiio'ation of of Sustainability,ano' the Logistics Management Branch in PGO.
Centers for Disease Controi and Prevention (CDC)

U. S. Department of Health and Human Senrices

404-639-?t3t

Consolidation DSHE BFD DSEP the 0 ice 0 and to istics Mono ement Branch

 

From: Daniel, Katherine Lyon (CDCIODIOADC)

Sent: Tuesday, June 26, 2012 12:20 PM

To: Frieden, Thomas (Tom) Arias, Ileana Villar, Carmen S. 

Cc: Hunter, Edward L. Henderson, Joseph Reynolds, Barbara S. 
Subject: FW: Timeline

As requested. I'm not sure of current status and use, but think it would be useful to post wf other info.

     

e-

to}
[31-1

Katherine Lyon Daniel, 


2 .
Accession Nomber: Specia191714 Page: 274 Sean Date: 2014-09?17 COPY

 

?1:13.734 {hire}
2523ll'l:

  

PRIDSAT)

 
   

 

 
 

 

From: 
Sent: 012 7:25 AM

To: (CDCIOPHPRIDSAT)
Subject: Re:

Holy cow.

From: (CDCIOPHPRIDSAT)

 

 

 

Sent: Wednesday, June 2012 06:45 PM

 
 

 

 

 

 

To: 3   
Subject:
The story continues. 5 quoted. Security breeches.
[Outoi Scope]
ibiiol

 

 

 

Division of Seiect Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE M5 A-d?

Atlanta, GA 30333

 

[blip

 

 

 

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This dOCument is intended for the Exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or confidential. and it should not
be disseminated, distributed, or copied. If you think you have received this document in error, please notify the sender immediately and destroy the original, thank you.

1
Accession Number: Specia191714 Page: 275 Sean Date: 2014-09?17 COPY



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Aacession Number: Specia1917l4 Page: 279 Scan Date: 2014-09-17 COPY

May 3! 

 

 

 

 

 

 

 

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Accession --Number: SpecialQl'Hd. Scan Date: 2014-09-17 

 



 

 

 

 Wok/W -
3108
AAth chase JR) @?l/we/r/u/yz mm;
 xiv-1m .. I .
Emiggwl  
Ngva N?f 5W 
if N0 .W?gm gen/3&3. (Vl3_9_f5rL).
W5W c195.
.. . . (3/th 
 n9? aw" HM 

. .meef'm [0w How 
?WAme putti.m PM

 

 

 

 

Eta/?Emma. .
. (Wm?  IUOMWWI
- wt.?
3.45"?  
Mmpw?cf ?15 WWCL. teem
?If: 

I    
Acce'ssi'onmmpecg?gl4? ?6395;  a?im?e; .13-

 e'scqlofrs, ww? 

- ?C?T?I?C?h?i?mAccession Numbei: Specia191714 Page: 

The?followjng- informatioan your request-of April 13, 2012; RE: Incidents During
Visitor Tours ofthe Buildingiuarium

1} Pleasefind-attacheda Form 3 along-wit'h-an' executive summary- (narrativ?el of events-including a
'timeline of what occurred. litlsh'ojuld be noted i it asSessmeht conducted by the-entityr
Office of Safety, Healthand 'Enuironmeht?the mug??ga?c? and-"the Program registe'red'for use
of Room did not indicate occurred during the tours:
based on the fact that Room had'Lbee'n-decontaminated for annual-facility maintenance
activities-and no work with virus-occurred the room decontamination and
the tour dates of February lei-and February 15, 2012?. in accordance With the attached DSAT
i? HVAC verification a transient excursion
does not necessarily mean for tho-containment block has
occurred. It --should also-be the praI'ri'e--dogs'th'at-iwere hou'se'd in Ream {333354;
time of-?the air puffinc-ident on ware-halve prairie-dogs that were transfer-red
{where ARBma'int'a'ins na'iu'e animals] asoer
?t-he attached logg'reco rd.



 
. .

We?

Naive Animal
dE

     
   

 

   

 

   

  

 

   

   

airflow-Issue

ante  Letter Narrative-Emma. .. limitation-Gm ..

(-2l'rdoo

~21 Ail-Balms provided were entered by the ?rst group of
visitors-on February lot-"2012.

 

 

Response: A'fioor-plan ofthe ulvjar'lum'is attached. i redomn??ndrcont?acting 

to complete details-on route taken on February Til, 2012 t'oUr. The information-provided below
related to room enter-was-obtaihed lay. AR-Bista-ff after-reviewing the Personnel Log in.Sheet for
the Building Vivarium:

 

 

- information documented on'the Personnel Log.5h?eet indicated escorted visitors entered
?1?3 :3 Thiaroo'rn was unassigned, didnot have anirnais present and was not hot on.
Februaryr 14, 2012.

i ml 
Enema-mme
?h?eetsmzaw?lizl 1-3t

   

Accession Number: Specia191714 Page: 284 Scan Date: 2014-09?17 COPY

 ARE being-I. performed in each of
the vivarium roemsc-en-Febeue?w ncl" February '16, 2012. The-regiSteI-ed 'Ioca ?ens. in the

Buildings Vivarium are=ihig?iigh?edfn. yellow: beltiw-.

 

 

 

 

I Response: perfermed in V3 riurn on
February 14, .2012 16,. 2-012:

rear-Hr? mjzr,3j::42 U30. 25231.11:

 

mm?; .m  


men-Maia

 

 

  ?Tl-?u . cums-winters.
. I Elam-?Lbs:

5. .u u-Ln-lu. I?-nnu- u- -. --

   
 
  

 
   



  - .. .-..  r"  new?
are $33 Rx?fg?h?se .t 

 

       

 

 
  

 

 

Reernfsiiae Unassigned},

 

  
  


-- Tyea'rumwa'semew. 

0 HOUR ewes}

Iteesaempty. 

 
 

 

41' enter inter-the Building 
blockfa re as follows.

Vivarium en ntai'nment

Reagan?: Entry .the-vivarium.
The-foilnwing isapre?'ideda:

       
   

 

es ,wa-s  . 
see?eoms Wise? tsh?feia r'dmeefc 19.3 m?t?eme?
lime,- . - 1 H?a?l?s . ..

an =25+?h9?3??1??renggt we; Gui-?e" was . 

 

 

      
 
 
 
 

 
 

 

.   
- .H-ac?tnaxlbnin-equls?o?

.11..- 'rv  . .

messes-en:

n]
.E

..

case

.44. A. sue r? a 13mm
mnemheef?ize?n1-rzz?bagns
1m: rr-M- t'm. 

if:
%1 



   
 

 

 

f? 
tray-r? =31: a. 
"254'
a emee?e?esee  We Wm;
(TB) Tweik-s'uit, bonnet, Inner shoe savers, outer shoe covers;
a Note: Rooms - "7 3 animals. Specific entry
require 2 will be  reitecgl driue 

 .- -.  "we? Ike.  I- 
yea-90mg 1113,42 etwhe   if;
it, a dime-Wu  .. sum 
'17. ., hp- 4 . .  113755 ?til- --.-I mil?; u-  
4? $3939 games Fm nlmals?f??mjj??sh?es
30 1h! shoes
- Clean carrid'or? No this?rea

The..procedure fer In?tp'are'as where vaccinatiun'is I
required as prouide? is as .fellews.

Accession Number: Specia191714 Page: 285 Scan Date: 2014-09?17 COPY

 

U.S.C. 252mm

 

 

 

c. 

wmkwithinfe??n-usagents wag-perfumed. in-

 
 
 

itesjiannge:Theilg?ac??ige 3? .
?gremnlad 
mm? prairie-idiagsr-were'
With-'fh? 5"e


 

 

 



A-R-Bthas pmuided delta-Elma ujgecil 'thra'-qghqut thief-Tcontainmenti bl'ockga-ncl
inc-Indin'g-a'nsr-anim-a his-thou fhn?rh 3?5 fan-11mm;

  

 

meal. ?Fag-"129' 'lb3?33?42 9510- 2523??: 
following;

 

i "uitiitS'IWitl? =metali?age?fpl-ate?- eg-hayst-i-
this'??e ho U'Se?fefriefs

?1:13:42 1

 

?pe?dfih?u'sing?m- Ruom


Accession NUmber: Specia191714 Page: 286 Scan Date: 2014-09?17 COPY

 

SJ BFG has-previded-Ihe following-responseio the- request for pressure trending-data for each of
the rooms in the Vivarium containment?leck during the-time o'f'th?e on
February 16,2612. Additionally; er. 'Director,-SOSHE, 'h'a'sfce'nveved 
no requirement-fro .maintajn-ireh'd'ing' ?ata fer ntiaE-readihgs. Pressure
differentiais are:=not- a'ir?ews and there is 'rm-require?mnt-that they be-cnntinUoUsly-mannered
and =reca.rded-..

   
 

a
f. -.-

Wearlumz-Dgor.
Pressure Differs?.

Accession Number: Special91714 Page: 287 Scan Date: 2014-09-17 COPY

 

 

Page 241

U.S.C. 2623(th

 

 

 

 

Page 242

U.S.C. 262a{h]

 

 

  
    

 DEPARTMENT OF Public Health- Sew-ice

I Centers for Disease Control
and-Prevention ECDC)
Atlanta GA 30333

111*? '10 

e, e"

4' 1?


April 13,2012

 

I [hilt-'12 USE. 262mm I

centers for. Disease Control and Preyention
1.600 Cl'i?oan'dad; NE, M-aiistop' A-2-2-

     

U.S.C. 2?2aih';

 

RE: Incidents Building Vivarium-

 

 

 

 

 

 

  

 

 

 

 

 

.on zeta-h-emeen wile-gee? Ate  ?eg?f?-iu-S-C-i
use. 25231113 I [b38342 USO 2523013 
 iirari-ium- space-L Raritieipa'n'te enteredgthe showered-net
upon exit i Feree WEISS: th?e [bf-[33142 usce
I minim U-S-C- 2523m3'mn6:  
Vivarium:
?30 [The?iistmoiid theaep'ti'en of touring the eiean cotri'dor-eutsrde
of containment; esEoEt.-a5

the i513?? in thei?iitB technician
insidep-pened room. Asithisdo??'?iese tiejff?e'f air eoi?ild be
felt Window-out into-the-oi'ean- corridor;

 

An' incident report-Ewes; - tdtvidetitto This ?re'p'o restates'thatgptainie dogs were
'eojnuaie?scing int-he with ind-?1? U305 -i.iiru5.fThe states.
that ca ref ateas-?eihe re aetivities wit-"h, U535
virus are-Ibeng co nd satiSi?aiitorv Jgre?ups' of rs 'to

the inset-:3 5-0 5?

 

 

   

In order to 15' and 157, 2012'wereeiexposedgteve- seiect'agent,
pi'ease on emit-20; 201-251

I Please-submit a-eempleted Forms along withan?ex'eeutive summary.tnarratWei-ef events
including. timEii?Er0f what occurred.

1: P-lea'se provider-detaileon which-rooms within the containment. hiookwere entered by the first
group-:of visitors.

I PIEase provide information on the work activities being performed: in aliofihe Vivarium rooms
duri'h'gfthe' time i'ntert?aisof the visit.

- What-is?are-the requirementisi for entry into the containment biock?

- Explaie the procedure entry of unuacc?inat'ed- individuals-into areas where-

ea'ccinatio?h isrequired.

- Please confirm t?heV-last-time that active work was performed'in procedure ro?om' 3? 3? . .
theto'ur be the: Second ."grotip.

'0 Provide "m "4 used'throoghout the containment-mock and including any
animai's housed 

 

 

 

 

Accession Number: Specia191714 Page: 290 Sean Date: 2014-09?17 COPY

 :10 DEM for-the Buiiding Vivarium space were
qualitative-end :l'aeked reef-in diffe'fe'n??i'?l preemies.trending-data. Pleaseprnvide pressure
trending date.er eaten-of biockdu?ng' the time of the
Second- gin u'p?s visit an Fe hruai?y'l'?, .2012.

 

U.S.C. 2623L'h}

If you have-qnestinnsxenneeming glease contact
the Fn?rn'l B'ma'ilh'ox'e't: form?s' nu:

On'all corresiacindenees regarding this TLR'iniiestigaition, please be sure te'inciude
ibir?" 
as well.

 

 

 

 

 

Thankyou in-advance-for your unoperation ang ceilabpretinn in this critieal investigation.

 

 

U.S.C. 2E2aih;

 

 

 

Vision: Ti: be-fhe agem midimxg?ns.

This dot-imam r?e'excimive n51: nf'riie giiove. remain i: prominent priviiegad. or
'cdn?demmi. and 'irninairia? lip: 'bid??fg'mi?bi?i fry-b1: are noi?rhe
gapymg-is we" Hrink you Ernie recqived' drawer}: in 

the sender i medime{v and downy. the original; Frankyou

Accession Number: Specia191714 Page: 291 Scan Date: 2014-09-17 COPY

 

 

Page 245

U.S.C. 2623(th

 

 

SUmmarV-?f?vents: Incidents [luringHisi?rTnuraof-the Buil'?ing: Vluarljum

Date of Incident: February 16, 2012

 

 

Background-:1. The Suites within the Bidgg'yitrariUm ate-designedrto cantainiinfect-iousagents
with'i n?ih?e rooms rough relative to
the este'm'al This i's-required lay-the editienef
"-Bio'safety i?nrmiero bibfe'gical $33.45 :is en-ferced' by

The 'preei'se-wo'rdihgfer the-current Vers?ionef .

 

Atiuct'edair??entilatinn- syttern-?i?s required. Thiaisystemmu st jprevlde-"sustained directional airflow by
drawing 'a?ir into-the areas. The
labera tot-Iv shew-be --cl'esigned 2'such'tha't the will not. be reversed.

 

U.S.C. 262al  I
raver) 89F:

Priese nt at..ih'itial We at

  
 

Incident:- On .tounmer?berswere iri-Ithe 3' 31 
?313142 'While-vlewihg prairie dogs
he1d with?ini-he ?elding- between the heldingi room and roam-clesed with
greater?ferce than required, sendingra- ism all ?put-f? ef'air o'utgithretig-hitihe Slotted win'dew and into the:
face of the DSAT visitor.

 

Date efilnitiall Response: Fe?ruarv 

 

 responders: Ilbiili33242 USE. I

 

Was'i'the h?bildin'g'dfh'ahre 
rJe'ee'nt decontamination in December Z?ll?anuaw
. U.S.C.

I.I

Initial response; The. last active-wonkjni' 3 5?
[553142 use. a 252m: 

from the CDC
2012, rte-infectious Weir-'k'h'a S'Itaken- pi'?'ce in: 
area-in-?Januaw-ZOIZ am no- infectious 
quitt't?h'rto' wi?dew should. not-have e'ccmiited! there was
All invoilived determined
neaequwre-accessed- a'hd thus-iiti-did' hat-'r'tr-ilg'ger' taper-ted te'the [3-1512
and to The closure issue-was; e'x?lained?te Wiliiams-jnAR-B'. .A call was made-ta'BFO' to.
have the. doors i-n'the suite examihedja-nd the deer cleatrres-Were'adju'sted.

 

      

 

Accession Number: Specia191714 Page: 293 Scan Date: 2014-09-17 COPY

 T-h'a; Duo! C?lps'ure Qamp'i?ete?; February 624-, 2032.

 

FW Vmarlum-door
alumna-nag

Date of Nati?catian to Rio: February 221-sz93.3

    

uti?czitjan; Dr, milison to the 
20.12:, Th  s?ghed mum-up acticm't'a
team members-rm 3 a? lain. F?'bm'arv'?i?, 20ft}.
to-uE?rify whether pr {If February 1'6, - o?t?al?'le incident to
3?5 E53354: 262 "into then-clean
c?rrii?i?o?f"a?s in mm 2523"?


S'u bsequentl'y, no'repp rt-WaSi submitted-t9- nee.

 

     
  

?3:13:42 
262m:

 

 

Panama-up- actig?sein?iud-??d a '?e?uest??ME that with a mitten

State rat-n1 share-with
?39333342 and.
provided-a p?fiFDf-aif Room

tom. Nazrharmel [b28342  on 'Febr-uaw Azcupv 9!
the written statement iszatta'c'hed.

 

     
     

 

April 9,;12012

 

 

373' Mina-far a training tour

nf'th e-Euil'dihg- Viva Hum?far ias-t'weelfmf Apr.? 2012.

Accession Number: Specia191714 Page: 294 Scan Date: 2014?09?17 COPY

April 13, 2012

 
 

received .letter-froma'D-SAT; RE: incidents During'Visitor Tours of 'the? Building --Viv.arium With-a
re'quest'to sub?mit?sa oo'm'ple?ited F'ormi3 along with. additidhai-informatio'n byICOB-oh Apr-H26, 2012. It
should benoted that the sent a request to'the mailbox requesting infdr'mat-ion to
assist in generating the respons'eby April 20,1012. The speti?caliy-requ??ted a list oftour members
contact information numbers and e-mail addresses to tour
participant interviews; olarific?ati?on- as to whether the reques'c from DSAT was intended to reference one-
o'r multiple incident; as w??li-as-ciafi?cation asto whether or not any of'the tour=participants were? seen
in-the-CD?E soughtmedicai follow-up eisewhe?re as a resuit-a resuitiof the
incident. Asaof Friday; April 20,2012, BEAT has not responded-to'therequest.

Accession Number: Special91714 Page: 295 Scan Date: 2014-09?17 COPY

 

 

 

  

To: .
Suhje?ct:  Vi'Varlum-door adjust'me?ts

 

Sent: T-uesda Aril 12, 2012 2-104 PM

. 3r . . 
Ce: Howard! William-{Bill} {seafocaofesHE}
SUbject: FW: Vivarium-dour adjustments

m}:sz . .. . . 
regardmg 1the deer-s.

   

I .
MB: ng?nl  I 
S'en't: Friday, F?ebmary 24, 2012 IDENAM
. 
zezam:   I a .
Wil1iam5,- Allison 
Cc: 

Subject: Vivarium door adjustments

    

?ll,

Doers-hambeen-adjusted to. ensure-that negative. Each-clears ih the central'corridor has been

 

 

 

 

 


Respect-fully,


.63. 30333



 

1

Accession Number: Specia191714 Page: 296 Scan Date: 2014?09?17



use. 252mm;

(cocmtemcez?le);

 

Branch, 

Office of Safety Health-a?d-?in?runmenn Centers for 1500 Cliftqu 

COPY

 .

 

 

 

        

   

..
From: Will i am 5; :Al 
Sent Tuesdal February. 2L 2912 
To: [him i  . 
Subject: Fw. Aicflowin 

gb?l?gi?-I-f if anyone has made-you aware. So-l thought-J would forward this to you just in 
Allison

. .. .. . lu-?i

 
  
    

$55113? 131  
rue-425$" .F?bruarr 16v 20.112 041-13 PM
eggs; _ll- 1? 
I I .. Williams: ?use,?
(cocxo-Iomcezxo)
'Subjeot-r Airflow 

 

 

Good- afternoo'n e't.al

This morning-was a 'part-of an-eseor'ited group that walked-through of-the clean areas in'the Vivarium of Bldg. and
wanted to make you all aware of?a circumstance'that the'group encountered.

 
 

As the group stood outside the door of i i? 33 . in the clean corridor, the ARB technician inside-opened-the door to? the
animal room. As the-door closed?every noticeable puff of air could -be-felt coming through the-slitin 

   hat th?i's'roorn does not house infected animals at the ijr'esent time.

 

 

 

 



 



 

 

 

and Toxins

Of?ce offPUblicHea'lth Preparedness and Response
Centers ffo Disease Centre]; and Prevention-
Rd. NE'Msms

aha-i:

 



 

 

 

Vision: To be-the'preeml'nent resouree for safety'ond--seeurity ofbioiogfcol-ogents and toxins.

1

Accession Number: Specia191714 Page: 297 Sean Date: 2014?09?17 COPY

 

 

U.S.C. 262mm

 

 

verification.-

 

 

U.S.C. 2523M:

 

 

 

The Federal Rolicy-is-hasednn the a?bmee BMBL Standards
as currently p?dh?li?s'h'ed' and i?s-subjject to change current palm-v:

[b?f33242 U.S.C. 252a[h:

 

 

 

 

Accession Number: Special91714 Page: 298 Sean Date: 2014-09?17 COPY

 

U30. 262301;

 

 

 

 

U.S.C. 252%:

 

 

 

Accession Number: Specia1917l4 Page: 299 Scan Date: 2014-09-17 COPY

 

U30. 2T32athj:

 

 

 

Accession Number: Specia191714 Page: 300 Scan Date: 2014-09-17 COPY

 

U30. 252mm

 

 

 

If' the re are any questionstaazbout this policy, please cont-act the CDC DSAT Facility!
U.S.C. 252m: [or the APH 
Fall-?it?s! Spatia?st u:nj:r3j::42 USE. 252mm at.  I at, :Imifd?i~12 26221111; I

 

 

 

 

 

 

 

Accession Number: Specia191714 Page: 301 Scan Date: 2014?09?17 COPY

  
  

 

     
  

 

 

   

 

 
 

- .-:  TIME 1: . .- 
 rm:  COMMENTS-

31%- 
i '1 .

214+ 
. I: 4m-

216:? . $31035-

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In? ?133451 

Bowie?; Ken Ll. use. 252a
Wii?sm {sin} {were mores-t5)

    
     

  

{cocrocoorosu-IEJ; Hduirard,

'Viya Hum ?oor-Pressure Differential

Pressure differentiai of the spaces; Within our \j?irarium are not r?eniter'ed Erie-the Buiidirjg?ut?emation System. The request
to. provide. differentials- Pressure
relationship. beween mom's isw'visihljr indidsted via'i-tell-tatei-tape.

Paul 
Asst. Director

Facilities Maintenance and 

Buildings and 

Of?ce: 40463940505

Accession Number:

Specia191714

1

Page: 318 Scan Date: 2014-09-17

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Tu: Rob-W?ant, 

 

 

 

 

 

  
 

meLlinB: I 01:16::- 
expomrexo CDC-Rawal '3
facility.
Data-max: 24, Ml). 
I  
Eurppse??epurt 

The-pm rpbs?' o'f?this re liq r1: iiru'x'd ascribe .t'he imiestgg?iq?rpian?illegatiEn  unsafe. ageratihg?fca n?lltians in in:
a?imal'hioSiif'et?i 
carnpu's'ih A?anta' G??rla. Accbk?in'gm??uj;  
ndg'ur'redjf?m?ngi} 
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?lial-$352012. Whine -tjlhis?rva_f_i_pa_5?made lay-the:
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so me .1312 'th E'd'a Eu'n'iEntS?: 5 pplie?d to .thEateam310 pariah 'ras ihaycoul?i?e.
Intg?ryiewspf-CDC -f??zand3cm1r.a?prs] were-
.cund'ucted5w'i'th =the as'surahte'tha'f Eomm?m?mbuNgehaM 'nqniajft'fibu?a'?te.

    

   

Ba'tkar?u?sl-

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26-10,: in pan, red Li'lr?'s: that "-th a?n??flhaltime
relaied Oversight ?ciivities offihe- F??d'e'ial ('s??s'js'EttjonEE?. if?oardina?gn pf:
Federal-?versf?ht?f?? 35.4 iTher?Diwirsfi?? at S?'l?eEmE?'nt?i? m1 waista'skei 941th
designing, developing; among:
"federa! zpa fin ersr partit'rpati gin US'it?a't?d?f?s's?sHrs,

 

in 
pf. provide 'Egumt; pat-mars that
condum'?internal? Inspeg?o ns- oper?'i'e: anarc??fuhd hid-bir? musty-1115mm. In
training willnen ?blejnspecturs and
APHIS. The Erogram tansists oijectures and trig-CBC Enfbal

campys.

ember-14. mu Fii'StJij' 

Class tansisieduf-??hebep? rJErn'ent rs;

 

Accession Number: Specia1917l4 Page: 319 Scan Date: 2014-09?17 COPY

Conference ca'ii'eras held?with'DSAT 

February-1, .12.
managers to clarify'entrv requirements for training classes.

Second. Program'training session-conducted at CDC.
Class consisted of 2 new DSATinspe-ctors and 2 inshectors-from the [?epa'rtment
of Agriculturefs- Animai and" Plant Heaith' Inspection" Service

Feb rue #141 2012

Program trainingsession conducted at CDC.
Ciassconsisted ole-inspectors from the Departments}! Defense

UIS the F'g'h'rua'rj 16% ag-alr?og reversal incident ocguggd w? Bethe tour members

252mm [9431-42-~ 'sriewina' (b.1334 animai holdingareas'through the procedure room d'oor of

.
252mm 

that iil'ust'rates the.quadra'nt of th?e-viuariurn in Building where the'incideht
2523??; lab area in this duadrant-are shown below

    

for reference-.-


262mm .. 1 I I. .- .I 
I: all-in?rm! In Illuul near uu?: the lnterlor Of lh?

U301. oratorv.'Entn.r into I horatory usually'requ'ires passage through a-central ante room seen on the ?oor
252%:  anshatween-rooms Passage through two self-closing doors is a basic design requirement for
31 paragraph However rooms In this vtuarlum are?also equipped
I Intofthe This door can beseen above the'numerai_2'in the
Iab?ion th'e ?oor plan. This door Is the 'Iocation where the trainees were standing at the tlme o'f the
door is equipped'with a window arid-an ohenin?g in the frame that allows-air to ?ow into the inner
USE-agree of'the Laboratory when the-v mtiiation system According to-the BMBL. edition.

r1 aborato'rv should ensure that ?The direction of ai?r?owinto the'animai

2623M: . 
facilityr Is inward; animal roo msmaintain?inward directionai airflow- compared to. adjoining halliuaus.? {p 52,

section 

 


2523M:

  

 

Accession Number: Special91714 Page: 320

 

 

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Accession Number: Specia1917l4 Page: 321 Scan Date: 2014-09-17 COPY



252mm







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Accession Number: Specia191714 Page: 322 Scan Date: 2014?09?17 

 





CDCRO'su'b??ts'initia'l report af'poterf?ai'r?leasetn DSAT [Form 3]

am asun- 



It.er '24, 101-2-









DSAT Requests meeting with CDC RD

WW

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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Accession Number:

 

 Powell. Nathaniel 
Black, Cafuwn 
Bowen, Keh'Ltenc-Iogqoxarm April 25, 2012 

-a gg 

- 

423012012. intervllewsiconduutd'ihyf 3'1 if:
sg  


Special91714 Page: 323 Sean Date: 2014-09?17

COPY

 

 



 

 


1] Themajar eoneerm'rqised byeny potentjal release Ingrown? 35M are -- ii 
exposure lef'1eborfalto'ry werkers-re bl'ohazards.   

Based en-a reviewa 
that there wasahv release suite_.d_uring the
Inciden'f th'e't occur'r'ie'dlti'?'Fehruaw 2012.

There me'inwardzdirectienal 
-F-,  .. 1-: 

I alrfiew.lnto'me space - I  
- I  If
mow co elmejl  

haw 

   
   

31? B?E?Eween: lawyewlmesgroi-me;event amime safe ?withxeay??
rau.W-. . - . 
 I-gfpu?ro?n?mrlanel?aar- ohthesne??eiv?l?uantigjsy??a 1
 ..    

       

4] There are devla?on's' 1' - euthered- i' ancefourid In the BMBL with reiizect ta'the design 
.and'aperaerens cur-the suites'lhdhe?ullding fva?um. Speci?cally, s?taies  
to areaS-whem InfecueuS'materiaIs-a nd'fer? animals are housedj-op'en Inwarew. eerie-see 
in the u'cumen't?, don'rsopenin?'g'lnte't?e central corridnropeh eLitw'a rd.

?Thls condemn. listed-Mme 

1113 nk- can-the decu merit. 

 

. d;

 

 

 

The seqund devletien iromthe Emu-guidance is the requirement that ?Eritw'Into'me-cenfalnmeht 'area

is a entry, which-constitut'esaa mantereen?alrlock end-archange mum.- Shewers may be
baseman risk-assessment._ An anteraom 

autoclave into end-o'er of the faculty."

While there:.is aantemom pmut'e'ed {or-enmirqm theeuter there are also
additional iduers lace red :1th these. labs from the outer cerrid or that permits en 'from 'the
Intathe which the transient air?ewrewersa!
.o'tcurred'. These ears metre clean 'cages into-?the suites during?operafiuns i'nc-Iudi'hgerees

-- . . .- . .l I I
used forworkman-otheragentshemdes- 929:5?? 3 I-andTEl'.  

 

pfete?are; mid ihat-a 'risk- asse sameniwasipe'rfn 
a Home this werh ?ow to he r, there was-nu written cepyof this risk-353255 men:

 

Accession Number: Special91714 Page: 324 Scan Date: 2014-09?17 COPY

      
      
    
 

mncemahwtihg diurepanw'behvee?'ihe guidance and this activity was

 
 
  
 

    

- . . . . -  - 11rd. Mrruw u:
detected zygw?g}  
I I

.- nr-"#32411' .iL-n 
53' There were "Eig?ia?i?gy??% magi--EW II- ?Uilnalln at
containmenF ma?a VIEW-1W1 Ear I  I 

af- air?'qw ban-keen. the-central corrid'or- teas-"was-oppnsite 'to {he

tarrectfdiraption. Elven the heaw reii'anceqrwisuali hdiga?qrif?f 



   

:Qniaihrp gui-cffapjlj?es detect air?ow
raversal's, this 

a: The reli?nt'e pn technoiogy. eisessev?mi
Swat-concerns. 1-1st the observed
the 
originated unlthe'dav ?fth ejncid 
the quasti'oh's bf haw r.  .  I  
mo; 

hefure-?ie-fab-??ga?n to I 

 

     

fwmmFmevwmem??iembm revs 11 Ha fa 1! amneer ?$504533;-

fxl?tw W?w? 51- f?eili ?eWr-t? Icur? 

 

     
   

         

  

 
 
     

     
  

 

 

 

 

4'51A?uJ-?nquf. 
was?me 411% nix-3mm :we're not info jp??eni andi-egp're ss?di' concern. As
is Howeygr,,seni_orEncpemnneWere
to these arrangeme?tw?s?bt


'93 Waive-IE mid-that-nofuture 

 

.1 I'll-nu h"!a - I?m-?l

AT bfr-LF} . ""vid-a'  

  

rle RT

   

Accession Number: Specia191714 Page: 325 Sean Date: 2014-09-17 COPY

 Wawere' treated with res?ecI-?anda receiv'Ed -profe'ssio?hal camper??an by the CDC and lathe wit-waived-
with -thi5'effurl.

Sur?manr

DSAT-cond?cfed .a In'BuIl'dlnat"
'the CDC Raybal campus was opera'ttng'und?r Based tra?insle?t
airflow remrsaI-?fromrthe Iabmatow .tH'rough abc-ut [he afan
exposure to infectious agents.

?iftef rev'uewlng memh?rs and - "In 
conducting tests .nf'the- vanilla lion-wl?tem filoes hotapp?ar to be .a'nv reas?bna?le?basis-to 
couplu?ezthat thera~was a Inf?ptlpus. o'f?ihe

 

primary it 


  
  

 66w

?Jaw mm; L-
- 
- wagging! .. 

 

Accession NUmber: Specia191714 Page: 326 Scan Date: 2014?09?17 COPY

 



 

 

 

 

1

 

     ..  . .  . 

 

ma" egg 

nib: neocoomwn

?lli?gn 
 Hi 2

m:.:3j::252mm  -- 
I?m rni I Erouu th'atwalk'ed ofthe clEan areas in themarium of  mam:er 0.5- 

.E. I'niw'n 1., on 11.null-1:. I: in. 

 

 

 

 

 

U.E 
252nm: 

    

 

    
   

    

the animal foani. As'tl?ie doorman; I .- I . h. be- hiswig.-

 

 

 

 

.?p?gg?ix 1 - Ilne?wuu?I-


 

 

(camcoogosm)
In II cncf?FHP'FUDsAfr)

-  
Allison [cat-ml  
:5?u'tilect: RE: Ali'?ow'ln 51:13} - 

   

awe?5)

  

 

Thankswe 

 

Accession Number: Specia191714 Page: 327 Sean Date: 2014?09?17 COPY

EDDIE:

(has:





?3316::


(one;

EDDIE:

Accession Number:

 

  
 
 

 

A



(cacfopnpefosm
 Itcoqoromcmm:

"0n beh'a?1fiof'f'ne Assoc?la Ee? Director for Science at BEAT we went to thank you for your

pa rtidpation an?d oomr?ltnientm?th?:Biological Select Agents and Toxlns Inna-regency Inspector
T'rairiing'UIU?Programe pmggam' isomibuted toyour? insightful-presentations:
enthusiastic and In'glstitai support Jghee-again, weoeeplv. appreciate,lali of-you for'taking
the?tirne to the.pi?ogram. We hopelo counton your support in the futum."

 

 

 

i *4
WI touolomcemo}
. ?1153'   

""It was-a jog! and'a'plea'Sure You ha've mu support?

 

(Co'egopueeyosnn
To: rowel; Nathaniel (cecyoi'omce?oj 
- Jim Itcocfoiomcezlo]

 

Subj?ett: Reque?t'l?ur?S?T Training

FoHo?Wing this morni'n ?rstl want to .thankqou for your support, we are twi mg
to schedule: traln'tn session-for the last weieknf for. [15:11" HE: participantsiu. lam-waiting
I to decideeon an encoder date. .To 'answer your question: the.
requirements .E'o-e nfec the ila 5i ?(We were and Tp?ooflof'piog'ramf rosinlfa'torv ?t test. Again
thank you-Tor your support.

 

6.

 

From: Poweil, Nathaniel 

Specia191714 Page: 328 Sean Date: 2014?09?17

COPY

   

  
 
 

magi: 1? I
 
 CDCJOIDINEEZIDM lib: llmr-r33:4 i;l 
Subjectzi?E: Requesi-fnr BEAT training.

 

    

 

    
  
 

 

[bl?f?l

 

   

 

Thanks

 

 



.. - I: sacraPI-Ir'niqs-Arn'; 
Cc'i'Frledgni?fhamas tTdi-n] ..
S'uli'jectr'HE: He?u??s?t fu?r Ira'InE-ng

fl] 1113 j:

[b31133



 

[bj:[3j::42 use. 


252mm ..


262mm

 

 

 

Regardi,

Accession NUmber: Specia191714 Page:

329 Scan Date:

2014?09-17

COPY

 



 

 

Netlonalf t?e ?ber; for. Emerging end-2o onotlc. rofec'ttous Disea se?s

 



 

 

 

 

Aggend?o: 

      

 

 

To; [bj:r.3j::42 use. 2522mm



 
 

HE: mildews-During Wsiton'Tours?of the (?33342 Vivarium

252mm

   
   

      

     
 
 

   

 
  

  

 

 

 

 

   
 

 

Lbirt3fi::42 U30 s-corted More 02:13:54; 
- - .. the-6mmEgmg U30  Participants entereome contar 1mengeneairlica?ramu  escorted-ESECOHd smug ta the

  

 

 

 

 

 

 -..-  . the thee . -
oreonta'inmenrr-they chose -this-0p?on and-dlo'not wear-mes. According mace . . . [bluf3iz42 USO. 
room' $181142 insthe clean ?of?dor. the Aaawechniclen 
insideopene?drrhe {lo-ortthejanimlelrruumrns very noticeable-purine! alr-could?be 

felt cornmgithrough the slitinurheawindorv-our corridor.

 

'An 'ino?dEnt reg-art -n - Idledjo USAT from Coco This report states-thatpmirle-dogs were
conuate?cing?n .th' a'ftei?rr'lmirtaixrrz use. 252m:- states
'mar-Juper'sons laboratory-or areas-where-acovltles-wlth
evidenceofsatihfaetonr vaccination. The mogrouos-of visitors to
-the u'iv'a'r'lurn lncluoed-rlhdivitlua'lsmiho hid he: been'eac?cinated order-to-oeterminevwherher the visitors-on February 14-and 15. 2012 we're exoosed ro'a-selec'iz'age'nt;
.please'p'rovidet?e. r'r?a'tion by. Edi-oh Aorii' 20, 2Q 12:

-- Please'submltae completed: execritive-summarv [narrative] of events Jn'c1uding.
t?rmel?lhe of who! oc'iturred'.

Pleaseprairi?edera'ilsian Whleh rooms withjn'rhe'conra?unment block wEre entered-by the ?rst group


- Please.mouldednform'ati'onon rife-work ae??i?esibelhgberfonned tnall otthe- rooms
during the ?me Inte we'ls of?re yisit; 

what iskrethe reg containment block?

- Expli'lfn the proce?dore for preven't'j'ngen'try'?f uacci'na?on
[5 required.

Pleas'E'ton?'rm 'the' lastr?me thaLac?ue wor
.tou file secondgroup.

Provide-'deta'ilsionxheo nimalahc usthg'ausedi?r rough out-1h econga?mrne nt btoek 
animals housed at?e??me-ln anlmz'lihoioing r00 - - 33 - -

 

 

  

Accession Number: Special91714 Page: 330 Sean Date: 2014-09?17 COPY

Previous HVAC providedi'tu the [b3l3j::42 U30. 
qu?llta tl'ue afodrh'idiffef?htial b?res'?'u r? ftrefiding-dataf._ Please"  
mm ?ach 0F mefrgams ?In. 'the 'vluajrt?m tbntainrnent block?juring the ?me?af-l?he sec and group's

.visit on:February-15, 2012-.


2523lh,? 

(bill: via the

  

Form 3 mallth HEW
an all correspondent estre gaming -thi? Thallnvasti'galtlon, plea sehe su rem Includ 

well.

Thankvuu In adva and-callabufa?cn?ln this Investigation.

Sincerew.

 

- 'hd?r 


I I 

252mm
Fer your e-rnalLand attachedletter'uf?p?i 13, $12, please ?nd attached the CDC response to your
in [he-Buildingm

re uest far-me to provide additional-l
during to?ursnn Eebm?aw-H?nd?Februaw 16. 2611.


tower Eisner-data

05M Email: 

Respectfully -sutim'it'tedi

   

 

    
   





I

m?i tame-lei.? ?.11 =1

 
      
  
    

UT. 

'I252mm   
??ai   
April. 25. 2012

 
 

 

Accession Number: Special91714 Page: 331 Sean Date: 2014-09?17 COPY

Dear -.

My "analogy for the. siren notice. gleam-be-admsegl of. BET: :e?quests to meet wim-yuluan? yoyr staff

on to marrow. at 1:3me gen cern iI-ifetm'ation teneived 'April
10,1012; reia te?dto - tine in cic?e? t?bf the ?t If wan-um Tears-Again, hing-a'poldg'ffbr 

notice-.3116 'd?ta'hk'gie'u'ih Hui-an ee? for Imu tests.

95: 1 am-nat? in the Df?ce this-mes?ageiish sting-sent via my Eleni-(Be mg. feel fre to
rese'an'd anther 

3' 42 ??lm F?w  

'rI I

265mm   
Agge?m 1



 

 

 

 

-- -  - 'T?Fol?matted: in?ame First;lihe:_ 

bji '2 . .. .


      

    

 

 

 

 

 

 

8.. :70:  
. . 

 

'(c?cyopaenmsm ..

Sublem; Follow up-tt: 4J25f2'?1'32. mee ting

?3 a s'e'jd- an my; to-request
your heip arranging interviews 

mite; "1i

[mm-12  I I 

262m: 
4] ED who-.pacticlpategrin HVACfunc?onaittesting-DI
345133 members {ten-leach]; We do wit sup'eriis'ors a?t'it?is tin-Le;

We 'Wd'uld iike IQ meet with-these ind ividyaissepa if. possibie;'w e-woul'd- {use-tn
schedule-1.5.420: theea 1:172:36? 'pr'nia my d'a'f next week; Df cc'gurse, we
ta acenm?mad a't'e ctitifiitts. the ?nainumber pfindi?dualsrwer
anticipate .b einget?etp ?nish by. Wednesdau, ,But-shaultI-Tthe; need-Iarilse, we~can i'ntewiew pee, pie later
in the week. Piease sentithe names and pre'pos'editimesthat 

in coul?pravid'e- me with the hunt-Hing?
infenna?ahjd'ocumentatioh;

1] the-date when'ithis ial: was lastrtested fer preper air?ow,

2] any documentatiun'af-ftitls testh

3} the date when the Iain-weed ?centarnina'tea'p?erfe the remitted air?ew deviation,

ahy'de-cumentation- and veri?catiawaf 
specific entry reqtiiremems for. the arid toid,

Specificentry-requirements-fer the-tiean $333142 areas outside cit-the?ab suites-

  
  

My. apologies ifvou have .airea dy provided tiny of this in imitation inthe documents cu rrentl'v .unti er
review.

We wuuidelmmte to conduct-a series-elf relativehr and;
severam?t ers-irr the same genealz'atea nextweek. Wezp [epose to stand-outside cf. the canta'tn'n-Ierit .
space'in .thetiean. wit? smeke of air?ow whiie'th'e-In'ner'dnor 

 

Accession Number: Specia191714 Page: 332 Scan Date: 2014-09-17 COPY

 the confelnrnent space'ls opened ni'ld closed eme seme'ma?nner tha't ceus?d'the enamel?
deserved We Hem; {System

manlguie tidnsaeranyleth erfm'eehenical' pmcedu res-:gd- b'eaperfermedd dying these tests._ We need
eeme'dhe from eitherAFlB inner-dear far-'earluus time lntervals
while-we db?se'r'e'e the smoke pettejme-?lrekh betel-?le of thevlal: area. These acrl?de's shouldproeide' useful
infurmatldq. tusef the uerllilailon system ?mcden.

.lf llkeite- diese- sim pT'eLtests on Thursday men-ling.

We appreclet'e you'ftoopera?bn.

 

 

[bll?l

 

 

 

 

 

 

 

 

 

 

   

 

 

 0.5' 
'Dleiefen mile 
Amending:
U. 
2523(h;  .
Please see below for the lnterutew scheduler-a: mlsweek'sihte'reiews. 'IJ'Liil' 7  i" -:
Tuesday-may *1 _Bulldingv__2d, Rommel-101A "lime: 101% am.
Individual: Dr. Nathaniel-Fueled
 .Tuemaxr May-1 tonedqn: 114mm Time: 10:30 am.
 
mm; name. Time: 11:60 am.
 .lndleldeale  -- I. -.
Tuesdae,_ nocatlon: Building medium 11-101?. Tlme: 11:30 am.  
Individual: 
Item;- I -
currently-on leave ef'ahsence June Inn-and has sdecl?ealle and'persunatlv  
:tdherfline- mada'g'ernent she gees-not wish to discuss matters related to the
Bulldin'g'.facllity with anyone.
- - TIME: 1-;00 pm.
?3-15; Wednesda? -u . . . .. 25, Ream 2111 Time: 1:30pm.
- 
m5, a . Le?cetldn: 'Td-Be Provided Tlme: 5:00 am.
we
Thursday; Mae-3 To Be-?Pmeided Time: 3:30 a.m'.lndiuidual 
mus:

The-"5rd eke test the: you re nested gogtelte place-inn Thursday momlng will'starret Me mbe rs
EEG and he-e?ila?ble 

Othen-?detumentatidn themes-requested In-zydur-eamall df 

 

Accession Number: Specia191714 Page: 333 Sean Date: 2014-09?17 COPY

Since tel-f;

[him-:42 
262mm ..
'Ce?ters foreign-ass on rdlzandle-Fremntinn

1 

 
 

 

rmugg-Im?rn?rm 133' 

 

 

 

 

Accession NUmber: Specia191714 Page: 334 Scan Date: 2014-09?17 COPY

Persne?nesls Log Sheet
B<uiifijc??ng Vivarium Sigh 

 

warme- TIME
 QUT

1.513%: S,




COMMENIS
.
2B

- - 45 
. 
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at;  EX ?79295?

'53 HaAccession Number: Specia191714 Page: 335 Sean Date: 2014-09?17 COPY

shg-@u1 
g? I 3KEE 

Accession NUmber: Specia191714 Page: 336 Scan Date: 2014-09?17 COPY

 

262mm 

Personnel Lag- Sheet

 Vivarium Sign In

 

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ENTERED



TIME
UT

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Accession Number: Special91714 Page: 340 Scan Date: 2014-09?17 COPY

 

 ?me-it Log Sheet 
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Accession Number: Special91714 Page: 341 Sean Date: 2014-09?17 COPY

 

 

 

 

 

 

 

. . 1:333:42 U30.
Eslza'm? 
U.S.C. -

252301:

 

 

 

 


2 2am: 

 

 

 



Accession Number: Specia191714 Page: 342 Sean Date: 2014-09?17 COPY

CDC Building: 

  :2 - Ilbjif3}:42 USE. 262mm. I
?waxInt-hat

2623th

ow_Vatua  Ealue

.- 

a1ib [Eli

 

w? Ht?m? cm 

Accession Number: Specia1917l4 Page: 343 Scan Date: 2014-09-17 COPY

 LI-SO-PIOZ UEDS va :a?ed :Jaqmnu 

 

CDC BUILDING    

 

 

 

. ?71"

U.S.C.
262301use;
252mm I zNar'ne:
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CBC BUILDING 

   
  

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Accession Number:

"teas-and; .

Special91714

fist-e  

Mame:
Us?ed:

line {31.0


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Inuit L'im

Device Uis?d:
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Page:

348



CDC Buninms ROBE-EAL GAMPUS

- ih'ejEt '1

aim-2 -

and-FD
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Scan Date:

aw 

2014-09-17

min" 4_2 

COPY

 ROYBEAL CAMPUS

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1m- 

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Accession Number: Specia191714 Page: 349 Sean Date: 2014?09?17 COPY

1500 :9190 LIEDS 098 :e?ed :Jaqmnu notsseoov

 
42

Lab-- egg-En: 503?? niti'ai:



31'

 

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EEC BUILDING (32:4 CAMPUS

{diff l-ibratidiniShfe '1
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Accession Number: Specia191714 Page: 352 Scan Date: 2014-09?17 COPY





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End of Report 

--.J

1603

 

 


E'ehf??fgr Eiisgase-iccrhi'rcl


 

TO:





in the 1"

ta. twice  $39542 
 U30. 2523M: I

 

U.S.C. 252a[h:

 

 

 

and 2136x1115.

 far and 'vae?n?on
1:600 Gli?o?-?ReadiN-?E, Maia-15:31:01: M6
Aid-th GA 30333"

  





:32:

 

Wis-a?um-

 
 
 
     

(if A pyri'l-

  
 

(bf.
[3:1

 

would-limit: describe: this, event-

 



 

on'F-Bbmm? "136's. 99?1-9 expressing
0011331113? an: This; em did-innit: ingiudc anyone from Lhasa
Compl'ianc? 61135113 had be an m;


Rs: ged'etem?na?b?'there- was: cation. sent to  

Hezaesrc'st?it .o were conducted
m,
RabbmiWeiya?mn April" 12'; Would be an
'Invgs?jgalion. I I
1?3,   
by A?t?i'f 20-, 72-012.
 $?ntan1?i??i?5fm1i6 requesting.
a?ddi?'onaininfcma?bn incider-~
2'6 hardback:  ingideritiiga'dtatennitred by to
 winged we 
fur-the: 

 

 

 

3 requesting-the: attached {33:30:15.6

 

'r 

Accession Number:

Special91714 Page: 354 Sean Date: 2014-09?17 COPY

 

USE. 2'52athj;

 

 

If yeurequire usplease d9 not hesitat?sto ?mutant 1118 Gr

 

submitted,

 

 . ..   .
..
Scitate--5Pn??y Program 055??

Of?ce-at" smelling, E?id?m?ggyfeagI-Ilgaborataty 'S'ervi?ces


1-600 Gli?qj; 1M Stop EH56-

Mtantm 30333 I I 

Tc?l?s?homcz; 54944986409.

.mv 20 01
L: dim

Accession Number: Special91714 Page: 355 Sean Date: 2014-09?17 COPY

 

    . .

Fram: Pam-=5. .?chc-gaeowam)

S'e'nt: Thurs day. jAjprT?  20 12-; 1.513 

. WM -

cc: tgow?nr Ken U.S.C. 252301: CDCIOCOOIDSHE): Hdward.?
Wliliam 

Subject: V'ivafiufni of 

    
 

 

to provide trendi?grdz?ita-of not-possible to accommodate. Pressure
relat?ions'htp hamster) rooms is visib?iy 'indicat?d-vi?a-?t?ll?l?lmaps.

spacethh?j?io?r magma-are- System. The-request.

Paul PE
Asst. Dir?t?tar

Facititie?as Mairitenancerand 
BUildin?gsaand 

Of?ce: 104-6 39-0505

.1
Acce551on Number: Specia191714 Page: 356 Scan Date: 2014-09?17 COPY

The-following information. Is providedin__'respo_nse' to your request of April 13,; 2012; RE: Incidents During
Visitor Tours of-the Building lJ-Iirarium

1} Pieasefinduattacheda Fonm Belong'3With'-a'n'-eitecutive summary (narrative) of events including a
't'lmeline of what occurred. it shot}le be -noted"?that a risk assessment conducted by. the-entity
Office of Safety, Health andiEnuiron'ment.'the 3?  and-the Program registered'for use
of Room ?33334 did-not indicate occurred during the tours:
based on the fact that R'oo . [ad'been decontaminated for annual-"facility maintenance
activitiesand no work with virus-occurred in the room-fbe'twe'enethe room decontamination and
the tour dates of February 14'and'February15, 2012?. in accordance 1With the attached DSAT

33 .HVAC veri?cation guidance-(fourth attachment below}, a transient excursion

 

   

 

 

occurred. It should also-she noted that housed in Room - 3 1 .

time-of the air puf?'incident 2012; ware-gnaive prairie-dogs that were transferred
"3  [where ARE maintains naive animals} as per
the attached log; record.

 

   

     

I ?an?Ed- - use. 2523
Ewan-1m Air?o- -- mm: Manatee Summa. .. dedication-Eu. ..
Naive-.Anlm al

Loo-042E120 Fancif-

-2i ARE-shes protiided faIl'owingsiocatians were enteced by the ?rst group of
visitors-on February Ida?20122
Response: Axfloor-plan of: the v'iu?a'rium'is attached. I recommend: contacting.
to complete details-on route-taken on February 1'4, eon-tam. The information-provided below
related to room lay ARE staff after reviewing the Personnel Log in Sheet for
the Building Vivarium:

umented onrthe' Personnel Log Sheet indicated escorted visitors entered
. This room was unassigned, didnot'have-ahimais present and was not hot on.

 

. .l 
31d. Nafium_Lo'g
1-3:

 

Accession Number: Specia191714 Page: 357 Sean Date: 2014-09?17 COPY

3) regarding workactivities in-eech of
the February 1:4, Z'Ui-Eiiand February 16', 20-12. leciat-ions'in' the


Ursa.

 

a? Requnse; Inezfollowing werkraetiiritiesgwere- performed in theqauilding Varium on
February lite-2012 and 

 use. ?23m:
415? I

  
 

r. 
Inta'ingdsinet-ubsl;

   
      

 

 


mm --.- 

 

 ?atfgd'mre' 2 7:1, 


o; 

I The-suitewasnot hut.

   
 

[520342 U..C. ?in3

. 'Jvcu I reg-l ef?ggnf - Gore; . .-. .- MST-(min 1.4.
at- Inedijntm 90 mm 

 

Cr 
-- The-room was.e'mpty. The-suite was-nut hot.
0. Emmi-Rabies}
Thrurn??siempty; The 'suite was-nut hot.

  

AR35has provided that .requitem'ents to enter into the Building Vivarium cantai'nrh'ent
block'a?re sis-fellows.

 

Raspense: Entri,r requirements axedemndent on the iocationufthestudy-within the 3 3? 33
Thefellowinginformatien is? 

 

    
 
 
   

   

    

  
           

 .   

--  -- i. new 

 'E??i?g?g?m?ai?ihim?4.1 
  
gaggi?yaiesgii'em ?guring-HM:

 

  

- - - inner shoe covers, Outer shoe cutters;
facility-shoes I
a Note: Specific entry
re quire ments- w-il l' her-1:; rotate]; riven.
- 'is-required in this area

5} The-procedure 'fe?r in?tp?areas where vaccination 'is
required is as renews.

Accession Number: Specia1917l4 Page: 358 Sean Date: 2014-09?17 COPY

 

USE. 2523M:

 

 

 

c. Training

6} ARE has provide-dine! t-he'l-a'st time 8.81:qu was-perform ed in
procedure room: [ml-33:42

 

__pr1er"tfe' groU?p-asi-fell?wg.

 

Response: The'l'asta'C'fiye mic-El?n" - 3: 3 'wes- dings beginning-January
.2012. Sinee the 

no 
movedLEntn ?tlg-Ie  252 withihe?s?e

en'imal?f?m the is};

Naive 'Ar'alr'nal-


 

 

Naive: prairie-{legs we re-

 

ARE-has provided 'anima'l hqusing used t?rQ-ugheut the containment blackvand

  

including any-animal?S-heused at-t'h'e't'i'me- in annimjelghafd-in'g morn M33142 foliows.

 

Rasponse: the] .:b}r3j::42 U.S.C. 252mm Ifatility-ce?nsists of-the
following:

 

- Individuaf and HEM-exhaust)
This type 'df Used tc?r hense-ipra'lrie-dbgs
- Du'ti?'o units-Withmetalcagesaplaced exhaust]
This-type huu??e'fer're'ts
- Tub holding containers {.I?is typeznf-eagifngfis used.tniheusegroups-of prairie-dogs)
Na?n?ve, thi's type-of housing in Room (?33:42 
February 1-6, 20.12.,

 

Accession Number: Specia191714 Page: 359 Scan Date: 2014-09?17 COPY

 thlemequest for. pressure :tnendingdata for each-9f:-
the rec-main- the Vivarium: containment. black during the?time df'th?e on
February Add?ifi?'r??'allw Di. that'therieijs
n0 requirement-gm tia'ta fur pressure differeritial'readings. Pressure
differentials are-snot air?aws and there they be cantln?ousw?mbnitored
and recorded:?

 

Dpur
Pressure Differs. ..

Accession Number: Specia191714 Page: 360 Scan Date: 2014-09-17 COPY

 

 

Page 311

U.S.C. 2623(th

 

 

 

 

Page 312

U.S.C. 262mm

 

 

 

 

 

 

 

 

 

 

     
 

   
 

 

 

 

 

     

 

(CDCJOPHPRIDSAT)

. (bits;- urogre} ?ragga; I I DCIOIDIN

I I Sent: Vlonday, April 09, 2012 3:4? PM

"bis-i To; .. .. mus:  licooroeHPRros - -. DCIOIDINCEZID)

to? Frieden Thomas {Tom} 3 3'37 Im3l33342  ?3?53
  CDC 1:05 . 1er ?am; Allison  
2623p:   (CDGOCOWOSHE) 

 

 RE: Request for DSAT raiig

 

II

(bail

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

 

Fae-nerds
[blli?l
(my I enter for Emerging and Zoonotio Infectious Diseases
(cocroeHPRrosz)
nt: Monday, April 09, 2012 10:49 AM
.Bw ., To: Powell, Nathaniel (CDCIOIDXNCEZID:gu'pject: Request for DSAT Training

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to schedule a
training session for the last week of April, 2012 for DSAT FTEs {5 participants]. lam waiting to hear back from
to decide on an exact date. To answer your question: the requirements to enter the last time
were TB test and proof of program! respiratory fit test, Again thank you for your support.

1

Accession Number: Specia191714 Page: 364 Scan Date: 2014-09?17 COPY

i"
mils:
HIKE:

HIKE:

 

 

 

 

 

 use (CDCJOPH PWDSAT)

Sent: ue 

To:'  ..  .. 
subject: FW: Training -. 



[bf-I262.



  

mus:

[bl-i5}

ibii?}

[bli?l

  

   

  

was instructed to cancel his training provided to I ntil some type of dialogue is established between

 

   

 

 

 

 

 

an USELS. I will be sending cancelation information to 3 3?73
Division of Select Agents and Toxins i' - - . . 

Office of Public Health Preparedness and Responses PM I
Centers for DiseaseControl and Prevention    

a mph; 3?s; his;
  linE} 

 

 

 

DSAT Vision: To be the preeminent resoorcefor the safety and security of biological agents and toxins.

Please consider the environment before printing this document is intended for the exclusive use of the recipient named
above. it may contain sensitive information that is and it should not be disseminated. distributed, or
copied to persons not authorized to receive such information. lf-jrou' are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited.? you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you. 

 

 

 

 

 

 

 .. - 
Sent: uesda Aril 2012 10:45 AM
To: 

S?bject; Training I I
 

 Laf'llErLi'

I will not be able to provide-training at the end of this month. See me later and we can discuss.

 

 

 

 

 

Of?ce of Safety. Health and Environment"  - i  - 

r?An?I-Am fru- nioaann Inn.

 

j:

 

trol and Prevention  

fut. this ?agellum-i Ila mu." r. .. m, 

 

 

will itAccession Nomber;-Specia191714 Page: 368- Scan Date: 2014-09?17 COPY

- at the and Of [his rnonu; JEL. tilt: 

 

 

 

 

 

 

 

 

 

  
  
 

(CDCIOPH PRIDSAT)

(C   
fhim-Sent: I I 20121121 AM

D: lib-J15;  
this? ?this? nco - - . erosmi

 

 

 

 a s_ trainingftour tor the Biological Select

252315u   
ppendix 4.pdf; Appendix 3.pdf; Appendix 2.pdf'. Appendix

$35.1: -- 

   

1 . 

 

Per your request I am attaching a report plus extra documents (Appendixes) for the case with the E?ii?f?s'c'g?
trainingftour for the Biological Select Agents and Toxins Interagency Inspector Training (IIT) Program.
Please let me know if you need anything else. Thank you

 

:42 
252L [I'll

 

 

 

DiviSIon of Select Agents and toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road. NE MS A-46

Atlanta. GA 30333

[bit 
252slhj:

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. it may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. if you think you have received this document in error. please notify the sender immediately and destroy the

original. Thank you.

1
Accession Number: Specia191714 Page: 369 Sean Date: 2014-09?17 COPY

1

Report

 

 

 

 

 

To: ma; (CDCIOPHPRIDSAT)

From: (CDCIOPHPRIDSAT)

cc: I?m??i 

Date: 5m201 2

Re: Report on the case with the trainingltour for the Biological Select

Agents and Toxins (BSAT) Interagency Inspector Training tllT) Program.

 

On July 2. 2010 the President issued EO 1354B ?Optimizing the Security of Biological Select Agents
and Toxins." This EO highlights the importance of Biological Select Agents and Toxins (BSAT) research
to national security and establishes specific requirements for the possession and use of BSAT. Section
6a "Coordination of Federalt Oversight for BSAT Security? of EO 13546 requires that ?the policies and
practices used to secure BSAT are harmonized and that the related oversight activities of the Federal
Government are coordinated."

CDC was tasked with designing, developing and implementing a training program that would
assure harmonized practices among federal partners. On June 28. 2011 the Associate Director for
Science at DSAT activated the first Biological Select Agents and Toxins (BEAT) lnteragency Inspector
Training (llT) Program. The goal of the program is to provide the knowledge. skills and experience to
Federal partners to conduct "internal" inspections of registered entities they own and operate or fund. or
to conduct joint inspections with CDC and APHIS. The program consists of lectures. and tours of
several sites of biosafety interest at CDC Roybal campus.

    

One of such tours is done in the tour is a great opportunity of entering the animal
containment facility. and is a critical component the Biological Select Agents and Toxins 
lnteragency Inspector Training (llT) Program. With the assistant and support from ARB personnel
DSAT was able to coordinate with the clinic to cover the speci?c entry requirements for the E33342
area. The requirements included serum banking. proof of enrollment in a respiratory protection program

and TB test. However. serum banking is a policy cancelled by CDC since the beginning of 2012.

  

  

fb}I23}:42 . . . . .
?agging ?it? is a full PA. - I a shower out facility. ADS-DSAT was providing another training

- 3 This training was "Introduction to PPE use and
maintenance". given by DSAT's Biosafety Specialist. During this training session concepts of PPE. and
facility requirements are introduced. Also. PAPR equipment is fitted. tested and provided to accompany
?it? training.

 
 

 

rb:.:3::42 uses
252mm

 

W. The ?rst trainingftour session with our DHS arlners was done on October 14th. 2011. The following

 
 



 

Accession Nomber: Specia191714 Page: 370 Scan Date: 2014?09?17 COPY

EEit?i

 



For the second trainingi'tour session with our partners, ADS-DSAT was obligated to clarify the
need for serum banking. According to the new CDC policies since 2012 there is no need tor serum
banking; however. Dr Powell Nathaniel was requesting serum banking. This was
done through several emails and a conference call on February 2, 2012. The participants were:
Weyant. Rob va ell. Nathaniel Black, Carolyn

Nicholson, Janet 
(CDCIOPHPRIDSAT). It was agreed not

- 9' 3? tour.

 

 

 

 

 

This second trainingitour had 2 sessions; one took place on February 14 and the other on February
2012. All participants enterin the animal area were trained, and provided with PAPR's by CDC-

DSAT b'gsafetv of?cer trait-rim? The following people participated in the first tour on February 14m
at 3 AM 0?

(APHIS). 's iwas the escort. Participants entere ed

PAPR equipment and showered out following the exit requirements of the  
session the participants were given the option of touring the outside clean area of the facility, so they
didn't use the provided PAPR equipment. The following people participated in this second tour on

 

 

 

 

 

 
 

uses


 

   

 --  I I was never informed of an incident happening
during the tours. At the end of the training I emailed all SMEs on February 23, 2012 (including 

 

iblt?i

thus-.42 uses
252sih:
uses
252mm



[b i: 

[h :1

Accession Number:

I

 You

 have my complete support" am including the of the email as Appendixr 1). 

tour for trainees from the Import Permit group.

[bti?i-

During several consecutives days I emailed and 
requesting their support. On 04t09i12 I was ?nally able to contact Dr. Powell over the phone. He 
to have a tour and asked me to send him an ema'mxm'IS-C- onding email. he requested me to
Wand for the tour (I am including the of the

   

252mm

email as Appendix 2). I emailed all of them, and I received an email back from 
informing me of the impossibility of helping us with the training due to an incident that occurred during
the last training tour (pdf of the email is attached Appendix 3). On an effort to understand the situatio
I contactedlm'?: lover the phone (04i10i12) asking him about the trai (?$133142
Ion why ADS-DSAT was never informed. i
I _n i ned that an incident happened during the second tour with the personnel. I aske
to please provide me with a report of what happened and any corresondin emails from 
I oncerning the case. On 04I?10i?2012 I received an email from on a
correspondence between him an:  7* - (I am including the of the email as Appendix 4).
Until today I haven?t receive any extra information concerning the case from any one.

[htt?i



 
 
 
 

 

     
     

   

 

Specia191714 Page: 371 Sean Date: 2014-09?17 COPY

 

[bli??

 



[11}[33242 

 

 

 

 

252mb}  
m- Sent: ,2012 5:31 PM
.  PHPRIDSAT)
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[Unl?ws?lce?(and copied ARE personnel) on the day of our last

. 'bl'Ei':
as been In contact  

    
 

 

 

252mm did not send me an more informatio a 
- - - - we
and other ARE personnel. I also read the memo from  

J:   

 

referring to, however I am sure she would tell you if you asked. Does the  
be back in the office on Friday, but until then, i will answer emails when i can.

ibiiBiI42 [11:13:42
262mb: 

 
 
   

3? 
I I Sent: Thursda February 16, 2012 4:16 PM
  (cocrom 
Stet-Rowe . at . Williams, Allison
(cocrotomcezm)
Subject: Re: Air?ow in 

 

 

 

 

 

Thanks 3' we will look into it.

set? U-
From:{cocr0PH PRIDSAT)

Ser t? Thurs-'19" Feh'uary 16, 2012 04:13 PM

 

 

 

 

 

 

       
 IrcocrOIorNcezm}; Williams, A1I'ison


Subject: Airflow in 
Good afternoon et al

This morning i was a part of an escorted group that walked through of the clean areas in the vivarium of Bldg. and
wanted to make you all aware of a circumstance that the group encountered.

uses . A 

25231117. the clean corridor, the ARB tEChHICial'! msude opened the door to the
animal room. As the door closed a very noticeable puff of air could be felt coming through the slit in the window out
into the ?clean? corridor. 1 was told by ?31(63- that this room does not house infected animals at the present time.

I I

  

 

[113153

 

 

 

FYI

Accession Number: Specia191714 Page: 372 Sean Date: 2014?09?17 COPY

 

03:03:

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers fo Disease Control and Prevention

1600 Clifton Rd. NE M5 A46

Atlanta. Ga. 30333

 

ma;-

UISion: To be the preeane?t?f?Ff??n resource or so on security of biological agents and toxins.

 

 

 

Accession Number: Page: 373 Sean Date: 2014-09-17 COPY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

 

 

 

?cocroeuemosim

From: Powell. Nathaniel (CDCIDIDINCEZIDJI
Sent: Monda .April 09,2012 3:13 PM

T01  ..  .. .  newn  

ca: Whit-51 pelts} Hons: .1 
L?bs?gtfl  
Subject: RE: Request for DSAT Training
(b2: 1 .V -. 

Please coordinate your visit with [a an  U305
Thanks
NP



 

    

(CDCIOIDINCEZID)

 

 

 

gull-?eet: Request for DSAT Training

Dr Powell

Following our conversation from this morning; first i want to thank you for your support. We are trying to schedule a.
 

trainin session for the last week of April, 2012 for DSAT FTEs [5 participants]. I am waiting to hear back from  
onedecrde on an exact date. To answer your question. the requirements to enter 

were TB test and proof of program;l respiratory fit test. Again thank you for your support.

-Accession Number: Special91714 Page: 374 Scan Date: 2014-09?17 COPY

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brualr?yI 23, 2012 3

 

  
 

 

 

 

 

 

 

 

  
 
 
  

 

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-  

Williams, Allison Powell, Nathaniel 


 Weyant, Rob 

- 

.S'ubject: RE: Thank YOU

have my complete support.
.. I

"Eiologistr?lsnimal Resources Branch
National Center for Emerging and Zoonotic Infectious Diseases

 

 

 

 

 

 

 

 

 

- - - - 


bruary 23, 2012 3:20 PM
5?  

   
  
  
   
 
  

 
  
     

  
  
 

 
 
 
 
  

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.. (col:er
llams, Allison (cocr01onlcezm); Powe Nathaniel ll 
[bit?i tbil?} i
 ?as Weyant, Rob . 
"We: 
Subject: Thank you

.I?l I:



   

DSAT)

           
 

   

   
  
  



.F

 

 
    
 

 

[0}[51





  



 

 

[oii?i

 

On behalf of the Associate Director for Science (ADS) at DSAT we want to thank you for your
oarticipation and commitment to the Biological Select Agents and Toxins (BSAT) lnteragency

- Training (IIT) Program. The success of this training program is attributed to your insightful
presentations. enthusiastic discussions, and logistical support.

 

Specia191714 Page: 375 Scan Date: 2014-09-17 COPY

Once again, we deeply appreciate all of you for taking the time to participate in the program. We hope
to count on your support in the future.

 

 

 

 

[blt?jz
Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS A-45
mam: Ash-"um. run 

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential, and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination, distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you. -

Accession Number: Page: 376 Sean Date: 2014-09-17 COPY

 

  



   

 

 

 

From: Powell, Nathaniel 
2012 5:20 PM
  
Cc: Weyant. Rob 
Subject: RE: Phone conversation - Requested information

 

Thank you very much for the information. I really appreciate your support.
(bite;

PSIBIFromtpmi'?? 3 

Sent": Tuesday, April 2012 3:37 PM

To: Powell, Nathaniel 

Subject: Phone conversation - Requested information

 

[blt?l

Dr Powell



  

Please excuse the delay on gathering this information for you. Per your request I am pasting a table with names and
dates ofthe trainingr?tours provided to DSAT during the last 12 months. Please let me know if there is anything else you

need from me. We reatly appreciate your support to our training program.

 

 

 


25 am}

 

c'

 

 (?[3342 tour date EL
time

2i14!2012-3r11130AM
2f14f2012-8-1130AM

2f16f2012?8-1130AM
glanolz-s-nsoam

gilalzolz-s-nzaoam
minnows-11:30 AM
minnows-11:30 AM
10f14j2011-B-1130 AM
minnows-11:30 AM
lortajzotl-a?lmo AM
minnows-11:30 AM

 

'hlama oopnru

(him;

 

 

 

 

 

 

 

 

 

 

I 

Thank you

 

[blt?

 

 

 

1

Accession Number: Specia191714 Page: 377

Sean Date:

2014-09-17 COPY

Training and Outreach Coordinator 1

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response

Centers for Disease Control and Prevention

1600 Clifton Road, NE MS int-46
as some

 

 

 

DSAT Vision: To be the preeminent resource for the safetyr and security of biological agents and toxins.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. it may contain sensitive information that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or
copied to persons not authonized to receive such information. If you are not the intended recipient. any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the
original. Thank you.

I 2
Accession Nomber: Specia191714 Page: 378 Scan Date: 2014?09?17 COPY

 

 

(CDCIOPHPRIDSATpri 11,2012 3:42 AM 
- loocroeHPRlosen toocxoee,Bar??ell: 
RE:  in   

   

1313!: US. . .
When are you back In the office?

 

 

 

 


Sent: "ues ay, Aprl 10,2012 6:31 PM



co" M53 

 

 

 

Subject: FW: Airflow in 

{and copied personnel) on the day of our last 

not send me any more information but I uess he has been in contact 
if



  

 
       

referring to, however I am sure she would tell you if you asked. Does the
be back in the office on Friday, but until then, I will answer emails when I can.

 



 

- . 
b?  February 16, 2012 4:16 PM
 rule-x42 I 
Williams, Allison

Subject: Re: Air?ow in 

Thanks we will look into it.

     

 

 

From: (cocloPHPR/osm)

february 16, 2012 04:13 PM

 
    
   

 

 

33355;}. (cocxocooxOSHE)
 .. Williams! 
(cocxommcezm)

Subject: Airflow in 
Good afternoon et al

,This morning I was a part of an escorted group that walked through of the clean areas in the vivarium of Bldg. and
wanted to make you all aware of a circumstance that the group encountered. 

1

Accession Number: Special91714 Page: 379 Sean Date: 2014-09?17 COPY

 

 

I As the group stood outside the door of - - in the clean corridor, the ARB technician inside opened the door to the
animal room. As the door closed a very noticeable puff of air could be felt coming through the slit in the window out

that this room does not house infected animals at the present time.

 

 

rims;

 

 

 

FYI

 

[Ulla]

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers fo Disease Control and Prevention

1600 Clifton Rd. NE MS MS



 

[b?i?l

 

 

 

Vision: To be the preeminent resource for safety and security of biological agents and toxins.

Accession Number: Specia191714 Page: 380 Scan Date: 2014?09?17 COPY

 

ti 3?  

ibii?l

 

 

 

  
  
  

 

 

 

 

 

 

 

.. -  
my;? 0.201212% PM
gig;  -- .. 
 yo RIBS
25:23:1' . ..  Interag a raining
(bits:

 

 

 

 

-- during the last Interagency Training in February and any corresponding emails

mi'i?ifrom  concerning the case. Thank you.

Following our conversation er the phone. I was wondering if you could please provide us with a report of

 

 

 

 

 



 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1500 Clifton Road. NE MS A416



 



 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

Please consider the environment before printing this email. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected, privileged. or confidential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the

original. Thank you.

1

Accession Number: Specia191714 Page: 381 Scan Date: 2014-09?17 COPY

 

 

(CDCIOPHPRIDSAT)

 
Tuesday, April 10, 2012 11:47 AM -

 

 

 

?To: Weyant, Rob 
[ml-Ute  ..     
Subject: RE: Request for DSAT Training
Dr Weya nt

On June 28, 2011 the Associate Director for Science from DSAT activated the first Biological Select Agents
and Toxins (BSAT) lnteragency Inspector Training (HT) Program. The program consists of lectures, and tours
of several sites of biosafety interest at CDC Roybal campus.



the assistant and support from ARB personnel, DSAT was able

to perform the first tour with DHS partners on October 14th, 2011. lr the past we have been able to coordinate
with the clinic to cover the specific entry requirements for the  11:12U'S'c'g

 

 

 

banking, proof of enrollment in a respiratory protection program and test. Serum banking is a policy
cancelled by CDC since the beginning of 2012. However, Dr. Nathaniel Powell from ARBINCEZID was

'20::[32442

requesting serum banking as an entry requirement for the

 

For our second tour with our partners, ADS-DSAT was able to clarify the need for serum banking. This
was done through several emails and a conference call on February 2, 2012. The participants were: Weyant,

Powell, Nathaniel Black, Carolyn 

I Nicholson, Janet Hibil?i l1  ibil?l
 It was agreed not to have serum banking as an entry 

 
  
    

 

 
 

entering the animal area were trained, and
The following people participated in the
land
lab using the

[b.?klnectgurs took place on February 15 and 2012. All artici ants

fb?fgiprovi  

-- 1  --

DSAT's SME was the escort. Participants er. 
provided PAPR equipment and showered out following the exit requirements of the,  
tour the participants were given the option of touring the outside clean area of the facility, so they didn't use the

. provided PAPR i and tour on Februa 15?? at 8 AM:



  

 

 

 

      

 

 

 

 
 

 

I was never informed of an incident happening during the tours.

 

 

 

Atuthe end of the training I emailed all SMEs on February 23, 2012 {including ?'33 Imimi?  to say
thank you for their support. replied ?It was a joy and a pleasu - - - ave my
complete support."

 

tour for trainees from the Import Permit group. I emailed and called

as well as Dr. Powell requesting their support. Yesterday, 04l09i?12, I was finally able to

 

 

 
  

  

 

 

 

 

 

m, contact Dr. Powell over the phone. He agreed to have a tour and ask ad he to send In his I 
reSpending."emailrhaura (his13134,; "an .262th: . . 
received an email from informing me of the impossibility of helpin with the training due to

 

 

 

an incident that occurred during the last training tour. Today, 04i?10i12, I contact - over the
phone asking him about the situation, and wh ADS-DSAT was never informed. I mentioned that
the incident happened. I asked [film to please provide us with a report of what happened and any
corresponding emails from "3163' concerning the case. i am waiting on a response.

   

 

 

Imus; llibii?i I
1
Accession Number: Special91714 Page: 382 Sean Date: 2014-09?17 COPY

Training and Outreach Coordinator

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1500 Clifton Road, NE MS 



 

ibii?

 

 

 

DSAT To be the preeminent resource for the safety and security of biological agents and toxins.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential, and it shouid not be disseminated. distributed, or
copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination. distribution. or
copying is strictly prohibited. it you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

From: Weyant, Rob 
Sent: Tuesday, __ril 10, 2012 6:56 AM

cocioeHeRiossr)
cc: libli?l ibif?} 
Subject: FW: Request for DSAT Training

 
 

 

Hi

Could you please find out more about what happened during the animal facility tour and provide me with a more
comprehensive briefing of the incident?

Many thanks.

Rob Weyant

Robbin  Weyant. 

Captain. USPHS tRet.)

Director. Division ofSelect Agents and Toxins
Office ofPuinc Health Preparedness and Response
Centers for DiseaSe Control and Prevention

Office phone: 404-? S-Ziliil

Cell phone: 

SiprNet: isatz??i?liricpdia.smil.mii

DSAT Iv?ision: To be the preeminent resowce for the safety and security ofbioiogicoi agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. it may contain sensitive information that is
protected. privileged, or confidential. and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lfyou are not the intended recipientts}, any dissemination, distribution. or copying is strictly prohibited. Ifyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

 

From: Ilbil?i 
Sent: Monda April 09, 2012 4:02 PM
  (cocioeHPRiossr); Weyant, Rob 

   

2
Accession Number: Specia191714 Page: 383 Sean Date: 2014?09?17 COPY

 

[0103:

- Cct.   
Subject: FW: Request for DSAT Training

 

 

 

 

 

 

 

 

 

Dr Weyanl and 
I thought this would be of your interest. I have another email from ?*3?53 saying how pleased she was to help
DSAT in future training sessions. I am not sure what exactly happelleu :0ch mar er lail

 

 

 

 

 

From: Imi?ii Illbilii I this? I. (CDCIOIDINCEZID)
Sent: Monday, April 09, 2012 3:4? PM
To: i= Powell, Nathaniel (Cpcxomrlilcezm)

 

 
 
 

Cc: Frieden, Thomas (Tom) libii?i  ii 
Williams, Allison 
(CDCJOCOOIOSHE)

Subject: RE: Request for DSAT Training

 

[b HE 

 

 

to; $42 uses


 

 

 

Regards,
{bil?i libii?l
Animal Resources Branch
rging and Zoonotie Infectious Diseases

 

 

 

 

 

    

(DRE:

 

 

 

 

From: I?m?m I  
Sent: Monday, April 09, 2012 10:49 AM
To: Powell, Nathaniel (CDCKOIDINCEZID)
Cc: I'm It?? Heir-?r limits   
Subject: Request for DSAT Training

 

 

3

Accession Number: Specia191714 Page: 384 Sean Date: 2014-09?17 COPY

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to schedule a
training session for the last week of April, 2012 for DSAT FTEs [5 participants). I am waiting to hear back from

decide on an exact date. To answer your question: the requirements to enter the last time
were TB test and proof of program! respiratory fit test. Again thank you for your support.

 

- 4
Acce551on Number: Speela191714 Page: 385 Sean Date: 2014?09?17 COPY

 

 

 

II


From: rhea?- 
Sent: Tuesda ,Ar? 0, 2012 10:04 AM

To: 
Subject: FW: Thank you

 

Ila 

 

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(CDCIOPHPRIDSAT 
 thus;-
I: i: {one}  
libil?? Illioiisi I 1 .
fists
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 Holt, James D. 

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Imus: Wevant, Rob .I

 .. 
Williams, Al i I 

mjzi

  
 
 

 



 

Subject: RE: Thank you

It was a joy and a pleasure . You have my complete support.

 

"lions; I
Biologistl Animal Resources Branch
erging and Zoonotio Infectious Diseases

 

 

 
 

 
Sent: Thursda Fe an,r 23, 2012 3:20 PM
-  Holt, James D. (coqocooloeo; 13"?
-
coc '1  3~ (cocxowpsxosm;  
we: 
  {cocyoapaxosmx line?I  
(CDCXOCOOXOSHE -i=i i=
421  we:
CDC the? (cooler: I 
 their Ilse (cocxoPHPRiossT); 
 - Powell, Nathaniel 
 
we: Weyant, Rois 
 
Subject: Then you  [use 

[were

 
  
 
 
   
   
 
 



  
 

  
 
  
  
    

 

 

  

 

    

 

  
   
  
 
 

 

 

 

 

 

 

 

 

 

     

 

 

 

 

 

 

 

 

 

 

 

 Williams, Allis
. 

    
     

 

     

1
Accession Number: Specia191714 Page: 386 Scan Date: 2014-09?17 COPY

On behalf of the Associate Director for Science (ADS) at DSAT we want to thank you for your 
participation and commitment to the Biological Select Agents and Toxins (BSAT) Interagency

Inspector Training Program. The success of this training program is attributed to your insightful
presentations, enthusiastic discussions, and logistical support.

Once again, we deeply appreciate all of you for taking the time to participate in the program. We hope
to count on your support in the future.

 

 

 ib3i53 mils: I

I ibjiisj: I
Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A46
Atlanta RA 

 

 

ibit?i

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

Please consider the environment before printing this e?mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential, and it should not be disseminated, distributed, or
copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

I - 2
Acce351on Number: Spec1a191714 Page: 387 Scan Date: 2014-09?17 COPY

i
i

i (CDCIOPHPRIDSAT)

 
 

From: (coorororucezio)
Sent: Monda Ari 09_2012 3:21 PM
To: lib-IE: 

 

Subject: RE: Request for DSAT Training

Either day works for me.

 

 

From: rm? 
Sent: Monda April 09, 2012 3:19 PM
-- Isl??4 -- (cocromrucezm);

     

bis-=4 'r  

will?l'To: mils? ..    -
(CDCIOIDINCEZID)
Cc: Imi'?? Powell, Nathaniel (CDCIOIDINCEZID)
Subject: Request for DSAT Training

 

 

 

We are trying to schedule a lrainingitour of the for the last week of April, 2012 for DSAT FTEs {5 participants}. Please lei me
know if Tuesday April 24 or Wd 25m from to 11 AM is possible. or please let me know of another timeldate. Thank you for your
suppod.

1

Accession Number: Special91714 Page: 388 Scan Date: 2014-09?17 COPY

(CDCIOPHPRIDSAT)

 

 

 

 

 

 

From: lib-?5i: 
Sent: 02.201211:49 AM
Eu: (CDCIOPHPRIDSAT).

c: . Weyant. Rob we: . 

i: i=1: {minim Imi'i?i- Irvin-'6: 


Subject: MEMORANDUM LETTER TO 

MEMORANDUM

LETTER TO 

Please ?nd attached the chain ofcustody letter with the SBU information. I am printing outand bringing to yen.
Thanks,

1
Accession Number: Special91714 Page: 390 Sean Date: 2014-09?17 COPY

MEMORANDUM LETTER TO FILE
July 2, 2012

Document type: Congressional Request for information

Dr. James Blaine, Deputy Director with the Division of Select Agents and Toxins
(DSAT), hand delivered to Daniel Browning, Supervisory Safety Engineer with the
Of?ce of Security and Emergency Preparedness, the following documents that pertain to
response to the Congressional inquiry by the House Committee on Energy and
Commerce dated June 25, 2012.

 

1. Documents pertaining to Amendmentl [133133142 

 

tbj:isj::42 use. 252mm

 

 

 

Facility Inspection repert and inspector notes dated 10f04i?2005

Facility Inspection reports dated 06f1312006 and 0611412006

Facility Inspection report and related documents dated 0111512003 (2 folders)

Facility InSpection report and related documents dated 0512712008 4 folders)

Facility InSpection report and related documents dated 109712008 (7 folders)

Facility Inspection report and related documents dated 0311 0'20] 0 (1 folder)

Facility Inspection report and related documents dated 10:f 1219012 (4 folders)

Facility Inspection report and related documents dated 12H 3f201 1 (1 folder)

0. 016 Referrals for discovery of select agents in unregistered [abs dated 6125108,
unauthorized transfers dated 8f141?09, and 016 close out of referrals dated
9129!] l.

1 1. Form 3 report dated 051261000? (1 folder)

12. Form 3 report dated 0113012008 (1 folder)

l3. Form 3 report dated 02f24f2010 (1 folder)

14. Form 3 report dated 051190201 1 (1 folder)

15. Form 3 report dated 0113012012 (1 folder)

16. Building HVAC facilities verification correspondence for I 3' i:

space

559?!?



 

registered

Veri?cation of receipt:

Date:

 

 

Daniel Browning

Date:

 

 

James Blaine

Accession Number: Specia191714 Page: 391 Sean Date: 2014?09?17

COPY



 

    

 

 

 

From: libel 

Sent: Monday. uly 02, 2012 11:03 AM

To: Weyant, Rob -  1
 

Cc:  

Subject: RE: Thoughts on today*s brief one: 

Please see below.

'l"hanks.

intro": 
inns:  I

 

 

 

CDC Division of Select Agents and Toxins
1600 Clifton Road MS n46

?fI-Jnfr: F: A 

 

[03033

 

 

 


Dirt-I To be fire ,or'ewm'nivii rectotrr'c'efcv' the .t'iffe?flJ (turf .rcrriti'riy rgf'iirologit-rri rigours and toxins.

This document is intended for the exclusive use of the recipientis) named above. It may contain sensitive information that is
protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipientis], any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

From: Weyant, Rob 

.2, 2012 10:43 AM

173?
Cc: 
Subject: Thoughts on today's brief

  

 

 



Good morning folks,

i?ve been thinking about today?s brief. Since it?s with Senate Appropriations staff, they may not know how focused the
House Energy and Commerce information request was, and may have some questions about our oversight of the roybal
campus as a whole. Could you please fill in the following blanks for data since 2005?

 
  
 

[bii312 . .
I   bal total. 30+ {we re OK here}
I I. Roybal total: 

Incident reports: Roybal ds?fo'i" 2 6 {including the puff ofair); Roybal total: 

mm 2 (recordwkeeping and unauthorized transfer); Roybal total: 4

262mm

 

Thanks

Rob Weyant

1
Accession Nomber: Specia191714 Page: 392 Sean Date: 2014?09?17 COPY

[b HS :2

[b EB 31

[bit?i
[midi

[bit?i

[bd?i

thiiB}

[bill??

[bit?i

Accession Number:



 

 

 

 

 

 'v'londe Jul oz, 2012 10:25 AM
TO: 
Sumac? RE: Congressional response

 I 

 

 

 

 

 

 

DC Division of Select Agents and Toxins
1600 Clifton Road MS A-46
Atlanta GA 30333

 

 

 




Vision.- in no the ,rsireeminent resonrrefot' the .srgter?v and security agents and toxins.

This doCument is intended for the exclusive use of the recipientts} named above. It may contain sensitive information that is

protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If vou are not the intended recipient{s), anv dissemination, distribution, or copving is strictlv prohibited. If vou

think vou have received this document in error, please notify the sender immediater and destroyr the original. Thank vou.

From: (CDCIOPHPRIDSAT)
?1  

S??iect: Congressional response

Coold I get the chain of custody document you prepared?

 

  

ivision ec Agents and Toxins

Of?ce of Pubtic Heaith Preparedness and Response
Centers for Disease Controi and Prevention

1600 Road, NE MS A-46

Atinntn GA ems:

 

 

 

 

USA Vision: To be the preeminent resource for the safe? and security ofbioiogieoi agents and toxins

1

Specia191714 Page:

393 Sean Date:

2014-09-17

COPY

(CDCIOPHPRIDSAT)

Attachments:

Importance:

    
 
     
   
   

.I -
J- .-

(CDCIOPHPRIDSAT)

2 11:54 AM

(CDCIOPHPRIDSAT)
HPRIDSAT)

if. ..
1i. . ..

FW: Email search
How to Search Emails Requested for CDC response to the Congressional  nquiry_
0?022012.docx; DSAT Email Search at CDCdocx

High

Sorry for the oversight, but you were not included on the original list 8c are not included on the attachment distributed
by Dr. Weyant. If you were not involved in any of the past incidents related to this congressional inquiry, you may not

need to take any action.

NOTE: I have attached instructions on searching. The other attachment is what was distributed on Friday by Dr. Weyant.

Thanks

 

[bitsz

 

 

 

OPHPRIDSAT

1600 Ciifton Road. MS 

Atlanta, GA. 30333

 

[b?i?jz

 

 

 

Website: 



DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

Sent: Monda July 02; 2012 8:58 AM
- i? 

    
 

      
 

 



 
ibiisj: I ?rst

 

 

Importance: High

Good Morning All:

a - . . DSAT)
  Weyant, Rob (CDCIOPHPRIDSAT)
Subject: RE: Email search

 

 

  
 
 
  
 

(CDCIOPHPRIDSAT 
Ire-is: I was: E. 

 

This message is a follow-up to Dr. Weyant?s Friday afternoon message concerning search your emails.

Accession Number 

1

Specia191714 Page: 394 Sean Date: 2014-09?17

 

COPY

thus:

[bl-(Bi: 



(bus:

[0103:

Accession Number:

Please see the attached for assistance {if needed) on searching your emails. Additionally, piease add "Duct tape" to your
list of key words of which to search.

Thanks to all.

Sincerely,

 

[0 

 

 

 


1600 Clifton Road. MS A-46
Atlanta, GA. 30333

[bit?i

 

 

 

 

Website: 


DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

From: Weyant, Rob 
Sent: Friday,_ June 29, 2012 2:09 PM

 

 
 
 
   
  
 
 
 

   
  

  
 
 

 

 

 

 

 

 

 

 

 

 

 

To: (CDCIOPHPRIDSATIDSAT): ta:t3::42 [b39142 (c 
. I

 

 

 

 

Cc: rm? ?this? (CDCIOPHPRIDSAT)
Subject: Email search

Importance: High

 

Good afternoon folks,

Unfortunately I have an acute request for you. Earlier this week we received a congressional inquiry regarding safety
incidents in Building Part of the inquiry was a document request that involved Emails. A review ofour Building
file indicates that you may have Emails relating to Building

I need you to go through your current and archived Emails and print out any that relate to safety incidents in Building
Please provide your printed Emails to no later than 11:00 Monday morning. Attached is a copy of a
search strategy that Kyle Wickes develope at may assist you in scanning your Emails.

 

Many thanks,

Rob Weyant

2

Specia191714 Page: 395 Scan Date: 2014?09?17 COPY

Robbin S. Weyant, 

Captain, USPHS (Rot)

Director, Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404418-200]

Cell phone: GTE-6144234

SiprNet: isatz??in?jricodiasmilnnil

DSAT Vision: To be the preeminent resource for the safety and security of agents and toxins.

This document is intended for the exclusive use ofthe recipient(s} named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. it'you are not the intended recipient(s}, any dissemination, distribution, 0r copying is strictly prohibited. lfyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

3
Accession Number: Specia191714 Page: 396 Sean Date: 2014?09?17 COPY

 

[bliS?I-i
252afhj

 

 

(CDCIOPHPRIDSAT)

 


262mm

Subject:

Attachments:



  

 

 

--  Weyant. Rob (cocroeneeiosan;
(CDCIOPHPRIDSAT)

list of documents to be provided to CDC today
Congressional Response list of DSAT docs sent 

Here's the complete list that will go out today.

Not included are: impaction folders for 10(4l2005. 6/13f2006. some inspector notes for relevant
inspections; emails from list of previous inspectors, file managers, etc.

 

 

[bf-i5}

 

 

 

 

[bit?i

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response

Centers for Disease Control and Prevention
1600 Clifton Road NE MS A-46
Atlanta GA 30333

 

 



 

 

Accession Nomber:

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents, hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged. or

confidential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended
retipient. any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender

immediately and destroy the original.

Please consider the environment before printing this e?maii.

Specia191714

1
Page:

400 Scan Date:

2014?09-17

COPY

OPHPRIDSAT
OPHPRIDSAT
OPHPRIDSAT



OPHPRIDSAT
OPHPRIDSAT
OPHPRIDSAT




OPHPRIDSAT
OPHPRIDSAT
OPHPRIDSAT
OPHPRIDSAT


OPHPRIDSAT
OPHPRIDSAT

OPHPRIDSAT
OPHPRIDSAT
OPHPRIDSAT


OPHPRIDSAT
UPHPRIDSAT
OPHPRIDSAT

OPHPRIDSAT

Re istration Amendment "25in;- 

Re istration Amendment
istration Amendment
istration Amendment
Registration Amendment
Registration Amendment
istration Amendment
istration Amendment
istration Amendment
Registration Amendment
Registration Amendment
istration Amendment
Re istration Amendment
Re istration Amendment
Registration Amendment
Re istration Amendment
Re istration Amendment
Registration Amendment
Re istration Amendment
Re ration Amendment
Registration Amendment
Registration Amendment
Registration Amendment
Re istration Amendment
Registration Amendment
Registration Amendment
Registration Amendment

Facility Inspection report and

Facility Inspection report and related documents dated 01f15f2008 {2

folders}

Accession Number: Specia191714

notes dated 
Facility Inspection report dated 06f13l2006
Facility inspection report dated DBIIAIZOOS

ng?ef?cml

Scan Date3,4

2014-09-17

COPY



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Facility Inspection report and related documents dated 05/27f2003 i: 4

OPHPRIDSAT folders} 3,4 2
Facility Inspection report and related documents dated 10(2732008 

OPHPRIDSAT folders} 3, 4 3
Facility Inspection report and related documents dated 03f11f2010 [1

ibii?: folder} 3, 4 4
Facility Inspection report and related documents dated 10f12f2012 t4

folders} 3, 4 4
Facility Inspection report and related documents dated 12l13i2011l1

OPHPRIDSAT folder} 3, 4 4
OIG Referrals for discovery of select agents in unregistered labs dated
6/25f08, unauthorized transfers dated 8!14f09, and OIG close out of

referrals dated 2 5

Form 3 report dated 05f26/200? {1 folder} 2,3 ,4 5

Form 3 report dated 013012008 (1 folder} 2, 3 ,4 5

APHISICDC Form 3 report dated 02f24f2010 {1 folder} 2, 3 ,4 5

OPHPRIDSAT Form 3 report dated 05f19f2011 {1 folder} 2,3 ,4 5

OPHPRIDSAT APHISICDC Form 3 report dated 018012012 {1 folder} 2, 3 ,4 5
Building HVAC facilites verification correspondence forIM

OPHPRIDSAT  registered space 3, 4 5

if
Accession Number: Specia191714 Page of6402 Scan Date: 2014-09?17 COPY

 

(CDCIOPHPRIDSAT)

 

   

 

 

 

 

From: Weyanl, Rob (CDCIOPHPRIDSAU

Sent: Sunda  Iy 01,2012 6:19 PM

To: this? I it?? 
Cc: 

Subject: Key Messages_ApriI Training Incident_2012-6-29

Attachments: Key MessagestApril Training 

Hi folks,

The key messages look good. Since we have some reference to 

Energize? mate rials. Could you folks please, over the next few 
clays, collect our Building 3 3: 3?3 inspection reports, incident reports, and amendments so that we would be readyI to
submit them if asked.

 

Many thanks,

Rob Wevant

. 1
Accession Nomber: Specia191714 Page: 407 Sean Date: 2014?09?17 COPY


Weyant, Rob 
Sunda .Jul 01 12 6:15 PM
- Henderson, Joseph 

Khan, Ali 8. ?33?s?   
e. 

      

 

 

 

 

 

 

?Us? ?13 3" 3* 
1:16;: we: 
W3- Holt, James D.
.

Subject: Congressional Response letter DSAT adds_2012-07-01 clean

Attachments: Congressional Response letter DSAT cleandocx

Hi

Here are inputs for the agency response letter'

 

Let either [hi-?3 3 know if you have any questions or concerns with these.

Many thanks,
Rob Weyant

Robbin S. Weyant, REP (ABBA)

Captain, USPHS (Ret)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Canters for Disease Control and Prevention

Of?ce phone: 404-? Iii-200]

Cell phone: 673-614-1934

SiprNet: isot209@iricp.dia.srnil.mi 

 

DSAT Vision: To be the preeminent resource for the safety and security of biologicoi agents and toxins.

1
Accession Nomber: Specia191714 Page: 417 Scan Date: 2014?09?17 COPY

 

 

Page 347

U.S.C. 

 

 

 

 

Page 348

U.S.C. 

 

 

 

 

Page 349

{133(5)

 

 

ibit?i

Accession Number: Specia191714

 

 

 

From: 
Sent: - ursa Line I ,2012 3:4? PM

To: 
Subject: RE: Electronic Documents

Sent at 3:29. Are you looking for something else?

From:  ibi=i?= (CDCIOPHPRIDSAT)
Sen? 07, 2012 3:45 PM
To: 
Subject: Electronic Documents

 

 

 

 

  

. . . . . . . m:
i left you a votce mail for the electronic documents involving CDC Budding [33:

ThanksCDC Division of Select Agents and Toxins
1600 Clifton Road MS A-46
Atlanta, GA 30333

 

 

 

 

http?nmvseleotaeentseovt

USA Vision; To be the preeminent resource for the safety and semi-try ofbtologt?cot' agents and toxins.

This document is intended for the exclusive use of the recipientls} named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive

Such information. If you are not the intended recipientis], any dissemination, distribution, or copying is strictly prohibited. Ifyou

think you have received this dOCument in error, please notify the sender immediately and destroy the original. Thank you.

1

Page: 426 Scan Date:

2014-09-17

COPY

 (CDCIOPHPRIDSAT)

 

From: Daigle, (CDCIOPHPRIOD)

Sent: Thursday, June 07, 2012 10:12 AM

To: Weyant, Rob Austin, A. 

Co: Khan, Ali 3. 

Subject: Re: USA TODAY article about air?ow issues in 

 

Rob, need material to sherri berger by 1600 hours today, so early afternoon to and ail should work. Thanks

From: Weyant, Rob 
Sent: Thursday, June 07, 2012 10:09 AM
To: Austin, nn A. 

Cc: Daigle, Khan, Ali S. (CDCIOPHPRIOD CDC OPHP
Subject: RE: USA TODAY article about air?ow issues in Building ?3313*? 2523??;

    

 

 

Hi Lynn,

How soon do you need something? We should have summaries and talking points responsive to the DSAT issues early
this afternoon. We can provide a more general response much quicker.

Rob Weyant

Robbin 3. chant, Phi), 

Captain, {Rt-3t.)

ifJirecttir, Division ot?Seiecl Agents and Toxins
()i?licc oi" Public Heaith Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404-? 13-200?

Celt phone: lat-7234

SiptNet: 

DSAT lit'ision: To be the preeminent resource for the safety and security of bioiogicoi agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. it may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. It" you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. Ifyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

From: Austin, A. (CDCIOPHPRIOD)
Sent: Thursday, June 2012 9:26 AM
To: Weyant Rob (CDCIOPHPRIDSAT)

Cc: Daigle, (cociopi-ipnioo); Khan, Ali 5. (cociOPHPRio i I I
Subject: FW: usa TODAY article about air?ow issues in Building with? i 2523"??
Importance: High

 

 

 

 



 

U.S.C. 5 

 

 

 

1
Accession Nomber: Specia191714 Page: 427 Scan Date: 2014-09?17 COPY

 

this? (CDCIOPH PRIDSAT)

 

 

 

 

 
 

 

From: O?Connor, Ann E. 
Sent: Wednesda June 25, 2008 5:52 PM
To: [his 
Cc: Weyant Rob I   CDCICOTPERIDSAT)
Subject: RE: El Building Talking Pointsdoc
[oil?libii?l

 

 

 

 

From: (cocicowssiosm)
Sent: Wednesday, June 25, 2008 5:26 PM

To: O?Connor, Ann E. I 
Cc: Wei/ant, Rob 
Subject: RE: in Building Talking Points.doc

      

cocicoTpERiosaiT)

 

These talking points were not reviewed by me or anyone in DSAT. In my meeting with libii'i?i I explicitly
. that I wanted to review these talking points before she forwarded them to anyone including you. I don't know
how I can communicate in more plainly than I have tried to do today. I have been waiting to review these since 2:30

  
 

About 3:15 today she informed me that she had spoken with Jason. Is Jason cleared and has a need to know about the
information? This may violate CDC SBU policy.

 

libii?i I libii?i I 
Division of Select Agents and Toxins

Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Arlonrn Convoie 
[biiEjI

 

 

 

 

 



From: O'Connor, Ann E. 
Sent: Wednesday, June 25, zoos 5:17 PM
To: this? cocicoTpERiDSATi, we: 
Subject: Fw: Building Talking Paintsdoc

        

As requested.

L?hn? . auxin. - wan -- . 

From: O'Connor, Ann E. (CDCICOTPERJOD)

Sent: Wednesday, June 25, 2008 2:43 PM

To: Broenlm Jason E. 
 (eocicoTPERiosiiT)

. 3 Building Talking Points.dol:

 



  

 

1
Accession Number: Specia191714 Page: 431 Sean Date: 2014-09-17 COPY

 

ib?zi?i

llbli?i

 

 

From: Skinner, Thomas W. (CDCIODIOADC)

Sent: Thursday, June 2012 9:23 AM

To: Berger, Sherri (CDCIDCOO Meechar, Paul J. Henderson, Joseph Chandler,
George ibli?} 

Cc: Grant, Llelwyn Daniel, Katherine Lyon (CDCIODIOADC)

Subject: FW: USA TODAY article about air?ow issues in Building 

Importanoe: High

 

 

 

Here is the email from Alison Young. Sherri Berger is coordinating responses and will hopefully have something baclc to
me by 4 pm. We'll decide next steps then.

Thanks

Tom Skinner

Senior Press Officer

News Media Branch

Division of News and Electronic Media
ode . gow? med in

office: 404?639?2851

cell: 404-625-2529

 

 

[Out of Scope]

 

 

2
Accession Number: Specia191714 Page: 428 Scan Date: 2014-09?17 COPY

 

 

Page 354

U.S.C. 

 

 

 

 

Page 355

u.s.c. 

 

 

 

 

Page 356

use. 

 

 

mire:



[bit?i

01:03:

{bub}

Accession Number:

 

(CDCIOPHPRIDSAT)

icocrcoTPERiosir-ir)
Tuesday, June 24. 2003 8:49 AM
Weyant, Rob (CDCICOTPERIDSAT
FW: AJC Article on Lab in Building 

 

 



.I .l
i
.1

(?hf Division of Select Agents and Toxins 1600 Clifton Road MS A46 Atlanta, GA 30333

 

 

 

 



This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that
is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly
prohibited. Ifyou think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.



From: (coercorrsruosar)

Sent: Tuesda ,June 24, 2008 6:33 AM
  
Subject: Fw: AJC Article on Lab in Building

Please disregard since you have already provided me with a draft.

Thanks,

 

 

.Agents and Toxins 1600 Clifton Road MS A46 Atlanta, GA 30333

 

 

 

 



This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

Message um

i. . "3 CDCICOTPERJDSAT)

 ..  CDCICOTPERIDSAT)
Sent: Tue Jun 24 06:30:58 2008

  
   

1

Specia191714 Page: 438 Sean Date: 2014-09-17 COPY



HS 
[t3 W3 i

(bite!

Accession Nomber:

Subject: Fw: arc Article on Lab in Building

 

 

 

 

Since we have been assigned to work on this together, let's get together today. If you are unable to meet, please draft the
initial document.

Thanks,

 

 

 

 

.leet Agents and Toxins 1600 Cli?on Road MS A-46 Atlanta, GA 30333

 

 



This document is intended for the exclusive use ofthe reeipient(s) named above. It may contain sensitive information that
is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient(s}, any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

Original Message 

From: 

To: lino  (coercorpswosar); -  i= 
(cocrcorpcarosar); this: ?this: 

Cc: O'Connor, Ann E. (CDCICOTPERJOD)

Sent: Mon Jun 23 07:55:57 2008

Subject: RE: AJC Article on Lab in Building

 

 

 

 

 

 

$133242 USE. 

 

 

Many thanks.

Rob Weyant

 

2

Page: 439 Scan Date: COPY

Specia191714 2014-09-17

 


lbhi?} I

(CDCIOPHPRIDSAT)

From: (coercorpeniosari
Sent: Tuesday, June 24, 2008 8:49 AM

To: Weyant, Rob (CDCICOTPERIDSAT
Subject: FW: AJC Article on Lab in Building
Attachments: Building Talking Poinlsdoc

'Fm??pmj

CUE-Division ofSelect Agents and Toxins 1600 Clifton Road M5 was Atlanta, on 30333

 

[bit?l

 

 

 

[b HS :2

thit?j: I



This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive in Formation that
is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. lfyou are not the intended recipient{s), any dissemination, distribution, or copying is strictly
prohibited. lf?you think you have received this document in error, please notify the sender immediately and destroy the

original. Thank you.




From: 
Sent: Tuesday, June 24, 2003 6349 AM

0r, Ann E. (CDCICOTPERIOD)

  

Cc: (CDCICOTPERIDSAT)
Subject; Fw: AJC Article on Lab in Building

This is not a productive working relationship. I am open to suggestions, but under the current working relationship this is
creating more work, not less.

Thanks,

 

of" Qeler?t Agents and Toxins 1600 Clifton Road MS A-46 Atlanta, GA 30333

 



 

 

 

Accession Number:



This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that
is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. lfyou are not the intended recipient(s}, any dissemination, distribution, or copying is strictly
prohibited. lfyou think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you. 

Original Message 

1

Page: 445 Sean Date: 2014?09?17 COPY

Specia191714

 
 

(CDCICOTPERIDSAT)

(CDCICOTPERIDSAT)

Sent: Tue Jun 24 01:35:00 2008
Subject: RE: AJC Article on Lab in Building

havee begun developing talking points for the 

 

(bub:

 

 

 

 

From: Weyant, Rob (CDCICOTPERJDSAT)

 
 



 

Sent: Monda June 23, 2003 7:56 AM


(CDCICOTPERIDSAT)

{bits} [blt?ji

 

Cc: O?Connor, aim E. (CDCICOTPERJOD)
Subject: RE: an: Article on Lab in Building

 

laboratory issue. Since I am not privy to certain information
related to the details ofthe laboratory and inspetion of it, I am not able to provide respones to the questions.

 

 

ib}i33:42 use. a 2623ih?bll5}

 

 

Many thanks.

Rob chant

 

 

 

[Out of Scope]

 

 

Accession Number:

Special91714

2
Page:

446 Sean Date:

2014-09-17

COPY

 

 

Page 361

use. 

 

 

 

 

Page 362

U.S.C. 

 

 

(CDCIOPHPRIDSAT)

 

 

From: 
Sent: Tuesda une 4, 2008 11:18 AM

To: 

Cc: O'Connor, Ann E. icocroorpenioo}
Subject: RE: AJC Article on Lab in Building

Just read Rob?s email. I guess we can inform Jason that we'll have something to him sometime tomorrow.

 

[b}[Bl

 
 
  

. (cocicorPERrosnr)

24, zoos 11:15 AM

. - =1 (cocrcorivER/oser); O'Connor, Ann E. (cocrcorPERioo)
Subject: RE: AJC Article on Lab in Building

 

lbizt?l

 

 

 

 

 


Sent: Tuesday, June 24, 2008 9:53 AM

       
   
 

  
 

   

To: Weyant, Rob - 33"? 
Cc: O'Connor. Ann E. (cocicorpeniosan; Roebuck, 

Subject: FW: AJC Article on Lab in Building

 

[bli??

 

 

 

Thanks,

[b1i53

 

 

 

 

 

Pnp?nivision ?elect Agents and Toxins 1600 Clifton Road MS A-46 Atlanta, GA 303 33

ibiit?i;

 

 

 



This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lfyou are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. lfyoti
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

1
Accession Nomber: Specia191714 Page: 457 Sean Date: 2014?09?17 COPY

 

(bile!

  

ibii?}

.. -  
subject: RE: AJC Article on Lab in Building

 


use;
252mm

 

 

i have-e begun developing talking points for the Faboratory issue. Since I am not privy to certain information related
to the details of the laboratory and DSAT's inspetion of it. I am not able to provide respones to the questions.

 

 

?nu-4:  -

From: Weyant, Rob (CDCICOTPERJDSAT)

23, zoos 7:56 AM

(coclcoTpERlDSAT); (coclcorpeelosm); (coclco'rpeeyosm);


(coclcoTPERiool

Subject: RE: AJC Article on Lab in Building



 

 

 

ib3i33:42 use. 

 

 

 

Many thanks.

Ftop Weyant

 

of Scope]

 

 

 

2 .
Accession Number: Specia191714 Page: 458 Scan Date: 2014-09-17 COPY

 

From:
Sent:
To:
Go:

Subject:
Attachments:

Received some great information from 3 373'

(CDCIOPHPRIDSAT)


Tuesday, June 24, 2008 9:53 AM
Weyant, Rob I-?i i=
O'Connor, Ann E. 
Von 

FW: AJC Article on Lab in Building
El Building Talking Pointsdoc

    

cocrcorpeniosm)
Roebuck,

 

He said to focus on conflict of interest and reported incidents

received from CDC and not duct tape (The duct tape response should cPrograrn). Since there is no

real pressing issue at the moment, this can be done next week. i will us

draft as a starting point and

insert what was provided for the Hearing (con?ict of interest).

 

 

 

 

gents and Toxins 1600 Clifton Road MS A46 Atlanta, GA 30333

 

 

 

 

 

This document is intended for the exclusive use ofthe recipientts} named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
Such information. lfyou are not the intended recipientils), any dissemination, distribution, or copying is strictly prohibited. lfyou
lhini-t you have received this document in error. please notify the sender immediately and destroy the original. Thank you.

  
 



 

. a . . um ..- mun-1.. . n.

Lab in Building

I laboratory issue. Since I am not privy to certain information related

td'the details grins laboratory and DSAT's inspetion of it, I am not able to provide respones to the questions.

 

Thanks,
inns: 
[Li-oi.  I
(BF Divisinn umC Fir-tier! t3
[bill??

(coercorpearosnrl
,June 24,. 2008 1:35 AM
- (coercorpenrosnr)
Subject: RE: AJC Article on
[bl-i5}
[bit?l

 

 

 

 

[Out of Scope]

 

 

 

Accession Number:

1

Specia191714 Page: 464 Sean Date: 2014?09r17 COPY

 

 

Page 366

u.s.c. 

 

 

 

 

Page 35?

use. 

 

 



 

(CDCIOPHPRIDSAT)

 

 

From: O'Connor, Ann E. 
Sent: Monday, June 23, 2008 9:20 AM I
To: We ant 
Imii?l

Cc: Roebuck, Von Broehm, Jason E. (CDCIODICDCM
Subject: RE: AJC Article on Lab in Building

Let's also consider whether we want to do some
stakeholders. Also, my guess would be that we
working its way through Congress.

proactive briefings on the Hill on this topic and possibly with some key

I don't forsee we would have hearings but you never know!

Let's plan on talking later today or tomorrow at the latest.

 

 

From: Weyant, Rob (cocrcorpsnicseri

23. 2008 7:55 AM
  .. 

 3- coc OTPERIDSAT)
 (cocrcoTPERroo)
Subject: RE: AJC Article on Lab in Building

 
   

need to be concerned about how this might affect the reauthorization bill .

 

 

use. 

 

 

Many thanks.

Rob Weyant

 

 

Accession Number:

[Out of Scope]

 

 

1

Page: 472 Sean Date: 2014-09-17

Specia191714

COPY



 

 

(CDCIOPHPRIDSAT)

 

Imus: rill-153 I DCIOPHPRIDSAT)
Thurscav. May 03. 2012 310 PM
revs} Iiblt?i 

cc. inns; 3 3" 3?

RE: Building a vivarium

 

 

 

 

[bjaf?jz

 

 



Subject:

I talked with a few minutes ago on his way downstairs to perform a couple more interviews with CDC
facilities personnel, and he said that he has already spoken with Dr. Wevant and will be providing him with a written
report. I don?t have all of the information since I have not attended all of the interviews, but I can tell you that the
vivarium rooms performed without airflow reversals today during smoke testing.  
lab doors at the clean corridor while CDC personnel donned PPE and entered vivarium rooms from the central corridor.
The CDC personnel opened inner suite doors and held them open for about 15 seconds, then allowed them to close, all
while we smoked the outer doors. There were no reversals of airflow observed at the outer doors. The vivarium doors
had been adjusted after the incident occurred.

 

 

 

From: 
Sent: Thursday, May 03, 2012 11:40 AM
To: this? (CDCKOPHPRIDSAT)
Subject: RE: Building vivarium

  

Yes, that would be great! I think Drs. Wevant an ll 3' would also be interested, but mav be planning to

debrief Dr. Wevant.

Elwin be out Mon Thurs.

 

Rob is out until next week.wi l be out all of next week. 

 

 

From: 
Sent: Thursda May 03, 2012 11:36 AM
i? 

would like me to debrief you on the visit this morning to the

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-46

Atlanta, GA 30333

 

1
Accession Number: Specia191714 Page: 491 Sean Date: 2014-09-17 COPY

 

ibii?:

 

 

 

vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient[s} named above. It may contain sensitive information that is protectedpriyiledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientis}, be aware
that any discloswe. copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this document in error, please

notify the sender immediately and destroy the original. Thank you.

2
Number: Page: 492 Sean Date: 2014-09-17 COPY

(CDCIOPHPRIDSAT)

 

 

 

From:  [his 
Sent: "vlonday AM
To: (CDCIOPHPRIDSAT)

 
 

Subject: FW: Centers Inspection

You have been left offthis communication. See below.


From: 
Sent: Monday, Aprii 23, 2012 9:05 AM

 

    

 

To:: 
  

 

Subject: RE: Centers Inspection

According to my recollection of the meeting with Dr Weyant, this affair is to be handled as a TLP. incident not a
compliance inspection. This requires that we give the entity days (which we did) to submit the written account of'the
event {which they did) last Friday.

Part of the form 3 process involves an immediate assessment of risk to the public and to the individuals potentially
exposed to the SAT. Should it be determined that there is significant risk to either, immediate action is taken. If not,
then a deliberate process of information collection and analysis begins. We are not under the impression that there is
any significant risk that the visitors to the lab in question are at risk for developing infections. So our plans
are to finish reviewing the information we received from CDC and set up a meeting and visit this week.

 

We will confirm the date and time with and let you know.

 

lime; ?tune;- I

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

[?glanta Georgia 30333

 

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

--?--0rigina  Messagen?n

 

 

    

 

From: this: 
Sent: Monday, April 23, 2012 8:40 AM
To: this? i   [we 
 
  [cocjopupnrosnm [cocropupnrosmi

 

 

 

 

Subject: RE: Centers inspection

Just saw 

 

- inspection will not occur today. and they have not determined when they will start this week.

1
Acce551on Number: Spec1a191714 Page: 493 Scan Date: 2014-09?17 COPY

 

 

 

 

   

From: {cocroeHenrosan

Sent: Monday, April 23, 2012 ?:36 AM

first?? {cool eHenrnsATi

leis: 

 

 

  

 

 


Subject: Fw: Centers Inspection
Importance: High

Hi all:

Are we proceeding with the compliance inspection of Centers 
to participate in the lab tour, and needs a heads up to prepare. Also, I'm short?handed today, and need to coordinate"an
resources.

Let us know.

Thanks, -- Rob



 

 

 

 

Oriinal Message 
 mm;uncommon
Sent: Saturday, April 21, 2012 09:19 AM

To: (CocroeHPR/osm}
Subiect: Centers Inspection

Rob,

Good morning. Just returned for Bostod was wondering if the inspection for Centers will still occur on Monday. I
as yet. Hope you have a great weekend.

Reoar 

 

ibh??l

 

 

 

. 2
Acce551on Number: Speela191714 Page: 494 Sean Date: 2014?09?17 COPY



 

 

 

 

 

 

 

From: Weyant, Rob 

Sent: Wednesday, September 28, 2011 1:3? PM

To: ibis?- 

Cc: this ri= 
Subject: RE: HVAC testing recap

Nice job. Many thanks. If they can complete their work to our satisfaction by the end of December, I?m OK with this.

Rob Weya nt

Robbin S. Weyant, (ABSA)

Captain, USPHS (REL)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Office phone: 404-? 3-2001

Cell phone: 678.6144284

SiprNet: jsat269@jricp.dia.smil.tn il

DSAT Vision: To be the preeminent resourcefor the sofer and security of agents and toxins.

 

From: (cocropHPRiosm')

Sent: Wednesda September 28, 2011 11:48 AM
To: W42- 
Cc: Weyant, Rob 
Subject: HVAC testing recap 

 

 

 

Thanks to you,nd all the other gentlemen who took the time to meet with me today. Here is a recap of our
conversation:

First we discussed the current status on the HVAC testing for buildings 
results have been provided to date to DSAT.

 

[Out of Scope]

 

 

 

Building I

For the lab in building suite}, there were initial tests performed when the lab was first brought
online, and witnesses at that time observed that the HVAC system operated as required to maintain secondary
containment. The facility engineers intend to reconstruct the tests which were performed and to write up the
observations which were previously made, and that should be completed within a few weeks.

. 
Acce551en Number: Spe01a191714 Page: 495 Sean Date: 2014-09-17 COPY

 
 

  suite} is scheduled to be tested next Thursday 10rd, anda report will be rovided
the following week, providing the testing is successful. For the building vivarium {gt-:42 suite, . . 
an suite), the exhaust fan failure tests have been successfully completed. Power failurefrestart testing for the

vivarium is planned to be performed in December during a maintenance shutdown.

    

 

[Out of Scope]

 

 

 

New Request

One thing which I did not say during our meeting but which 1 am requesting now is that DSAT be provided with the
results of the power failurefrestart tests for the building 15 spaces and the results of the exhaust fan failure tests for the
building vivarium spaces. Because it was said today that these tests were successful, I would appreciate getting the
results to whittle down the list of remaining items and to be able to demonstrate the total amount of progress made
toward completing this project. i am also requesting that an update be provided to DSAT, once available, on the Gomez
boosts"; zselsuite} results even if potential problems are noted, for the same reason.

 

Summary

?3:131:42
252ain:

It is - inion that a significant effort is being made by registered entity CDC to comply with request to perform

verification of the registered areas. It is understood that performing these tests, making any
necessary HVAC modifications and then doing subsequent retesting can be very labor intensive and time consuming. I
told you that I thought that the December retesting projection for the building vivarium power failurefrestart would
be accepted by DSAT because other registered entities have been encouraged to perform the tests during maintenance
shutdowns. The use of annual leave by testing personnel prior to the end of the year and the December holidays could
present problems, however, for meeting this projection. Please consider whether these factors reduce the likelihood of
this timeline being met, and provide either a confirmation or a revised estimate for the building vivarium retesting
date.

it is probable that the inspection will remain open until this testing has been successfully completed. Please let me know
if anything stated about the testing status in this email is inaccurate.

2
Acce531on Number: Spe01a191714 Page: 496 Sean Date: 2014-09-17 COPY

Yours truly,

 

 

 

 

?3315i 3: j: 
Centers for Disease Control and Prevention
Office of Public Health Preparedness and Response
Division of Select Agents and Toxins
1600 Clifton Road, MS ill?46
mus: Fi? 2mm?

 

 

 

DSAT's vision: to be the preeminent resource for the safetyr and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientlsi named above. It may contain sensitive information that is protectedmriviledged, or con?dential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If vou are not the intended recipientis}. be aware
that anv disclosure, copying, distribution or use of the contents ot this document is strictlv prohibited. If vou thin'lt vou have received this document in error, please
notify the sender immediater and destrov the original. Thank vou.

Accession Nomber: Specia191714 Pag?: 497 Scan Date: 2014?09?17 COPY

 

 



 

 

From: Ilbil?i' 
Sent: Monda ,Jul 02,2012 1:37 PM
 
Subject: FW: Request

Message-m-

From: (CDCICOTPERKDSATJ
Sent: Thursday, June 05, 2003 1:51 PM

To: I 
Subject: Fw: Request

 

Sent from my BlackBerry Wireless Handheld

E. Ph- D-

Associate Director for Science

Team Lead

Coordinating Of?ce of Emergency Preparedness and Emergency Response Division of Select Agents and Toxins
1600 Clifton Road, MS A46

Atlanta, GA 30333

Of?ce: 404.718.2010

can

cuv4@cdc.gov

This document is intended for the exclusive use of the recipient(s} named above. It may contain sensitive information
that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls], any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediater and destroy the original. Thank you.

 Original Message 

From: 
To: (cocxocoorossp)
Sent: Thu Jun 05 13:49:34 2008

Subject: Re: Request

 

 

I plan to have you some guidance by COB tomorrow. The response to our concerns on the building loss of power will
certainly be on the list. Any other items I hope to get to you tomorrow.

Thank you,

1
Accession Number: Specia191714 Page: 522 Sean Date: 2014-09?17 COPY

 gnu.?

Sent from my BlackBerry Wireless Handheld

E. Ph. 0.

Associate Director for Science

Team Lead

Coordinating Office of Emergency Preparedness and Emergency Response Division of Select Agents and Toxins
1600 Clifton Road, MS A46

Atlanta, GA 30333

Office: 404.718.2010

Cell: was:
cuv4@cdc.gov

 

This document is intended for the exclusive use of the recipientfs) named above. It may contain sensitive information
that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls}, any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

 

 

 

 

Cc:   . {cocrocooroSEP); Porter, winiamlcocrocooxosspn jocrocoorosm;
 

 

(CTR)
Sent: Thu Jun 05 13:41:06 2008
Subject: Request

 

 


At the out-brie?ng for our inspections last week of the Program and Special Pathogens Branch Building 5652;?
space, it was mentioned that we could aniticipate a delay in our entity's receipt of the amendment approval
{amendmen I or the [$34 Division based on overarching concerns that affect all programs projected to occupy
the We asked for an e-mail highlighting those speci?c concerns so that we may work to resolve them in an
effort to minimize delay for approval of the Flu Division's amendment. I realize you are out of the office this week, but

can you give us a projected date for when we will receive that correspondence?

 

 

 

  
  
   

Thank you in advance for your attention to this matter.

 

 

Centers for Disease Control and Prevention Office of Security and Emergency Preparedness Personnel Suitability and
Select Agent Compliance Br

1600 Clifton Road, NE, Mail Stop A-ZZ
no 2013.1

[on 33442 


 

 

 

 

OSEP Customer Satisfaction Survey
1Etmeth=BSO&proiect=CDCOSEP> .

2
Accession Number: Specia191714 Page: 523 Sean Date: 2014-09?17 COPY

This document is intended for the exclusive use of the recipientls} named above. It may contain sensitive information
that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls), any dissemination, distribution, or

copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original.

3
Accession Number: Special91714 Page: 524 Sean Date: 2014-09-17 COPY

 

 

inns: CDCIOPHPRIDSAT)

 

 

 

 

 

From: ?lb-?53 

Sent: Monda ,Jul 02, 2012 1:3? PM

To: (CDCIOPHPRIDSAD

Subject: FW: Registration Amendment: IfS-?Effglerl this: Vivarium - 1X05 CDC 9385
KB

 

 

 

Sent: Thursday, May 01, 2008 5:58 PM
To: ?bit-53* (CDCICOTPERJDSA

cc: ions,?  xiv.-  
Subject: Registration Amendment: It i clari'sshoazoqu

 

    
 

 

 

 

 

. CDCIOCOOIOSEP)
Vivarium - IXOS CDC 9385 KB

Good Afternoon

  

Please find attached registration application amendment documents for Principal Investigator 'i 562a H27 this
requesting registration of i? . Vivarium sace in Building If at all a ssible. we would like to schedule inspection of
- a. in the Building 3i i? - Vivarium at the same time inspection of the

space is scheduled, May 29 a ay 30. 2008.

      
 
 

 

 

Thank you in advance for your consideration of our request. Please feel free to contact me if you have any questions
regarding the information submitted in the attachments.

Kindest regardsl

 

runs: 42 
4 52am;

 

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[iris 4205.0. 


 

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for Ihe exclusive use ofthe recipientfs) named above. It may contain sensitive infomiation that is protected, privileged, or con?dunliul, and
it should not be disseminalcd, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientts}. any 
distribution, or copying is strictly prohibited. Ifyou think you have received this document in error, please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 525 Sean Date: 2014?09?17 COPY

 

I one: 

 

  

 

 

From: Fit-'53 

Sent: 012 1:3? PM

To: 

Subject: FW: Facility Inspection Report Response 1X05 CDC 1708 KB
From:  (cocrocoorosem

 

 

Sent: Tuesda August 19, 2008 4:56 PM

To;  coercowsnrosm)

(CT - - -  
Subject: Facility Inspection Report Response - 1X05 CDC 1708 KB

    
  
 

 

 

. (CDCIOCOOIOSEP)

Good Afternoon

Please find attached responses to your requests for additional clarifications on requirements noted during your inspection
and Special Pathogens Branch. Please also note

Branch Incident Response Plan will be provided by close of business tomorrow afternoon.

   

Respectfully submitted.

 

 

I

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[we :42 use. 
252?th-ji- . 

 

 

 

 

Customer Satisfaction Survey.

 

This dooumenl is intended for the exclusive use of the reeipientis) named above. It may contain sensitive information that is protected, privileged, or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such inlornlalion. If you are not the intended reeipientts}. any dissemination,
distribution. or copying is strictly prohibited. If you think you have received this document in error, please notify the Sender immediately and destroy the original.

1
Accession Number: Specia1917l4 Page: 526 Sean Date: 2014-09-17 COPY

 

 

I PRIDSAT) 

 

 

From:  '3?3'363' ?mils? 

Sent: Monda Jul 02 2012 1:36 PM

To: 

Subject: i=3 1: Lab: Updated Renovation Schedule - CDC 17'1 KB
Impedance: High

 

 

From: '37-?33? (CDCJOCOOIOSEP)
Sent: Tuesda Auc ust 05, 2008 6:28 PM

To:  (cocicorpsatosnr)
Cc: Weyant, Rob (CDCICOTPERIDSA 

 

 

 

  

.   

-  --  - - T3- 3 . Edwards, Jacqueline Nicholson,
Janet Chandler, George Bowen, Ken L. Chosewood, L. Casey
(CDCIOCOOIOHS Popovic, Tanja Stevens, John R. (CDCIOCOOIOSEP)

Subject: WW Lab: Updated Renovation Schedule - IXOS CDC 171 KB

Importance: High

   
 

 

Please ?nd attached our entity response to your request dated, July' 23, 2008, for an update on the schedule for that-tenses
in?? Laboratory renovation project. 2523"?

  

Respectfully submitted.

 

[bj-i 3:42 

252aihj

 

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE, Mail Stop tit-22

Atlanta. GA 30333

3; 33:42 uses
 

 

E-

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the reeipientts} named above. It may contain sensitive information that is proieeted, pn'vileged. or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such infomtation. If you are not the intended reeipientfs}, any dissemination,
distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 527 Sean Date: 2014-09-17 COPY

 

 

(we: I OPH 

 

From: this? ?this: 
Sent: Monda ,Jul 02, 2012 1:36 PM

To: 
Subject: FW: Floor Plan - IXOS CDC 564 KB

 

 

From: 1 3 El. (cocrocooroSEp)
Sent: Wednesday, June 25,. 2008 2:10 PM

 

   
  
  

 

  

1mm: rm:- CTR
Ce:   item (CDCICOTPERJDSAU:   (CDCIOCOOIOSEP)

 

[byg?g?gcte Ioor Plan - IXOS CDC 564 KB

252a[h:

submitted in the registration amendment application fo
(and-l? let the time) on Setember 26, 2005 sent vi- FEDE) tracking number

 . . . -. 0181.242  
which was accessioned into DSAT on November 2005, under amendmen $105252 

 



 

 

 

 

 

 

 

Respectfully resubmitted,

 

thit: I42  ..
252m:

 

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop 

Atlanta. GA 30333

in}. 


 

 

 

 

 

OSEP Customer Satisfaction Survev.

This document is intended for the exclusive use of the reeipicntt?s} named above. It may contain sensitive information that is protected, privileged, or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. if you are not the intended any dissomination.
distribution, or copying is strictly prohibited. "you think you have received this document in error, please notify the sender immediately and destroy the original.

1
Accession Nember: Specia191714 Page: 528 Sean Date: 2014?09?17 COPY

 

I was; I (CDCIOPH PRIDSAT)

 

 

 

From: I?m: (C 
Sent

To: 

Subject: FW: Charters - 1X05 CDC ?03 KB

 

 

coo/coweeressr)

I - (coercoTPERrossT); the: use? IrcoqcoreemossT) 
(CTR)

Subject: Charters - rxos one 703 KB

  

 

 

icomponents that will be registered to the-3.3.4.2 use. 
2 fb'gram and to Special Pathogens Branch. it was mentioned that have a Governance Council and Operating 2523?

Group assembled to address facilities operations and policies. The Manager-     

 

 

 

   

the following attachments for your information-?charters for the Governance Council and Operating Group. Please 
adached.

Respectfully submitted,

 

  


262ath':

   
    

2a 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[tijzis :42_u_s_c_s
252athf:-~

 

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the recipientis} named above. it may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended reeipientis}. any dissemination,
distribution, or copying is strictly prohibited. If you think you have received Ihis document in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 529 Sean Date: 2014-09-17 COPY

 

 

I rims:  

 

From: Iml?? (C 
Sent: Monday, July 02, 2012 1:36 PM
To: 

 

 

Subject: FW: Amendment] 's-D-g?i?gtg?zi Ixos CDC 1357 KB

 

 

 

   

From: Itbi:t3i::42 I . 3'   
Sent: Monday, May '19, 2008 5:04 PM

 

   
  
 

To: the the: I (CTR)
Subject: Amendmen - Ixos CDC 185? KB

  
   

 

 

 

 

request, please linear
262'""  [bjit33142 us. Please also note that under the agents listed for Rooms

      

  
   
 

U.S.C. 2623M:

 

hould be interpreted to meanvirusesi

 

U.S.C. 262mm

 

 

 

Respectfully submitted,

 

[b?f  
252m h"

Centers for Disease Control and Prevention

 

 

 

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE, Mail Stop 

Atlanta, GA 30333

[eye 42 uses


 

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the recipientts) named above. it may contain sensitive inionmttion thal is protected, privileged, or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to such information. If you are not the intended reeipienlts}, any dissemination,
distribution, or copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original.

1
Accession Nomber: Specia191714 Page: 530 Sean Date: 2014?09?17 COPY

 

tbjri?} (CDCIOPHPRIDSAT)

 

 

 

From: 

Sent: Monda Jul 02 2012 1:36 PM

To: one: 

Subject:   Request for Additional Clari?cation: Facility Inspection Report

 

Laboratory and Vivarium-"Bldg -1xos CDC 3240 KB

 

 

(CDCIOCOOIOSEP)
Sent: Wednesday, April 02, 2008 10:03 AM

 

 

 
  
   

 

 

To:, mat 
Cc: ?333342 Edwards, Jacqueline (CDCIOCOOIOSEP)
Subject: Responses to Request for Additional Clari?cation: Facility Inspection Report Laboratory and ?31334

 

Vivarium-"Bldg - IXOS CDC 3240 KB

Please find attached a cc of our response report to our most recent request for additional clari?cation for our facility
inspection report (Bldg ?13334 Laboratory and ?31334 Vivarium space}. Also provided as separate ?les are the
HVAC balance test records as requested.

      

Do you know whether or not we may still be receiving additional questions under separate cover from USDA for this
report? Thank you in advance for your assistance with our entity's registration matters.

Respectfully submitted.

 

my: :42   

ocoArH-

Centers for Disease Control and Prevention

 

 

 

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop int?22

Atlanta. GA 30333

rejrs :42_u_s_c_s
 

 

 

 

 

Please visit OSEP Customer Satisfaction Survey and tell us about your recont experiences with 

This document is intended for the exclusive use of the recipients} named above. It may contain sensitive information that is protected. privileged. or eontidentil. and
it should not be disseminated, distributed, or copied to persons not authorized to receive such infomiation. lfyou are not the intended any dissemination.
distribution. or copying is strictly prohibited. Ifyou think you have received this document in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 531 Sean Date: 2014-09?17 COPY

 

mire: 

 

 

 

 

 

From: I'm-53' 

Slant: Monda Jul 02 2012 1:36 PM

To: 

Subject: FW: Response Report to Inspection Report: i: Division - IXOS CDC 6942
KB

 

 

  

. ocooiosem; Zambuto, Laura R. (coercoorncmo)
rt: Division - 1x05 CDC 6942 KB

 

n. ttached a 'pdf? copy of the report develop to i no to the ?ndings reported by USDNAPHIS Inspector. 
from the January 15. 2003 inspection of our Division laboratory and vivarium space in Building 

  

Please feel free to contact me if you have any questions or concerns regarding this submission.

Respectfully submitted,

 

 I
Centers for Disease Control and Prevention
Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop A-22
Atlanta, GA 30333

 

inns 42_u.s.c. 


 

 

 

Please visit OSEP Customer Satisfaction Survey and tell us about your recent experiences with OSEP.

 

This document is intended for the exclusive use ofthe recipientts] named above. it may contain sensitive inl'onnation that is protected, privileged, or con?dential, and
it Should not be disseminated, distributed, or copied to persons not authorized to receive such information. lfyou are not the intended recipientts}, any dissemination,
distribution. or copying is strictly prohibited. Ifyou think you have received this document in error, piease notify the sender immediately and destroy the original.

1
Accession Number: Special91714 Page: 532 Sean Date: 2014-09?17 COPY

 

ibit?i 

 

 

 

 

   

 

 

From: I?bii?i Ilmi??i 

Sent: Honda" ?9 9012 1:36 PM

To: ?"53 

Subject: FW: Additional Clarification: Facility Inspection Report (Amendmen ui'lisii' 25 - 1X05
CDC 4667 KB

Importance: High

 

 

  
 

(CDCIOCOOIOSEP)

March 25, 2003 3:32 PM


. (CDCICOTPERIDSAT) 3'
Subject: Additional Clari?cation: Facility Inspection Report
Importance: High

 
 

Please find attached additional clari?cation as requested in your letter of March 12, 2008, to address Requirements 1, 
.- nd 8 of our Facility Inspection Report for the Building ?3334.. Division inspection under Amendment


 

Feel free to contact me if you have any questions regarding this submission.

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

mgr. 
2s2srhi. 

 

 

 

 

Please visit OSEP Customer Satisfaction Survey and tell us about your recent experiences with OSEP.

This document is intended for the exclusive use ofthe reeipientts) named shove. It may contain sensitive infomiation that is protected. privileged, or con?dential. and
it should not be disseminated, distributed. or copied to persons nol authorized to receive such information. lt?you are not the intended recipientis)? any dissemination.
distribution, or copying is strictly prohibited. lfyou think you have received this doeument in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 533 Sean Date: 2014?09?17 COPY

 

Iibti?t I 

 

From:
Sent:
To:
Cc:

Subject:

{CDCrocooroseei
Thursday. February 07, 2003 1:05 PM
tcocrcorPER/osnri

 

this? ?this: (CTR): tcocxcorpeexosor)
(CTR) 

RE: Select Agent Inspection Response Report

Thank you very are most appreciative of this and look forward to the revised report.

 

ibji 3:42 

 

252sin?

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness

Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop A-22
Alma. GA 30333

tugrs :42_u.s.c. 
 

 

 

 

Please visit ggstomer ?urvey and tell us about your recent experiences with OSEP.

This doCurnent is intended for the exclusive use of the recipient?s} named above. It may contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated, distributed. or copied to persons not authorized to receive such information. it you are not the intended recipientt?s}. any dismminalion.
distribution, or copying, is strictly prohibiled. If you think you have received this document in error, please notify the sender immediately and destroy the original.

 

 

 

Holmes,  

Thursda Feb cry 20081203 PM
 cocrocooroseet

torts} [use] (CDCIEQTPERJIDSATJ . 
RE: Select Agent Inspection Response Report

 

 

 



 

 

I apologize for the confusion the report has caused. The departures referencing Appendix of the NIH Guidelines were
inadvertently left in the report in our haste to get it out to you. We will have a corrected report sent to you ASAP.

 

From:

 

Accession Number: Specia191714 Page: 548

lib} 
Thursda Februa 2008 12:33 PM
tcocrco?rPERrDSAT) 
- - '351?3342 Zambuto, Laura R. Keyes, Kathleen (CTR)
FW: Select Agent Inspection Response Report

     
 

 

Scan Date: 2014-09?17 COPY.

Kathleen Keyes is the ID Safety Coordinator. She has raised the fotlowing question regarding citations noted in your
inspection report for them Division inspection of the High Containment Lab and [ii-?3342 Vivarium in Building . Can

you provide clarification for us as per the e?mail below?

    

 

Many thanks in advance for your assistance.

 

 

Lug-?tn, a or

 

Centers for Disease Control and Prevention

Office of Seourity and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

my 
 

 

 

 

 

Please visit Customer satisfaction Survey and tell us about your recent experiences with GSEP.

This document is intended for the exclusive use ofthe named above. It may contain sensitive information that is protected, privileged, or confidential, and
it should ttot be disseminated, distributed, or copied to perSuns not authorized to such information. It you an: not the intended any dissemination,
distribution, or copying is Strictly prohibited. It? you think you have received this document in error, please notify the sender immediately and destroy the original.

 

Keyes, Kathleen (CTR)

Moods - 04, 2008 1:15 PM

 {cocrocooroscpt

Zambuto, Laura R. Nicholson, Janet 
RE: Select Agent Inspection Response Report

  

Is it possible for you to check with the National Program concerning the Findinglebservations 9-13? These issues
reterence the NIH Guidelines Appendix 0 [see below}. The intent of Appendix 0 is to provide guidance for large animals,
such as those that cannot be contained in standard laboratory caging (cow, pigs, chickens. etc.) within the labs. 
not approate for the type of animals and containment that Flu {or any of the other Programs) will be using in the
Space in .

KK

     

 

20.3.0.5
23th:

APPENDIX 0. PHYSICAL AND BIOLOGICAL CONTAINMENT FOR RECOMBINANT DNA RESEARCH
INVOLVING ANIMALS

Appendix 0 specifies containment and confinement practices for research involving whole animals, both those
in which the animal's genome has been altered by stable introduction of recombinant DNA, or DNA derived
there from, into the germ-line (transgenic animals) and experiments involving viable recombinant DNA-modi?ed
microorganisms tested on whole animals. The appendix applies to animal research activities with the following
modifications:

Appendix (It shall supersede Appendix (3 (Physical Containment} when research animals are of a size or have
growth requirements that preclude the use of containment for laboratory animals. Some animals?yreguire
other types of containment (see Appendix Cl-llI-D, Footnotes and References for Agpeno?r?xdglijhe animadsf
covered in Apgendixpare asianintals including but not 

The Institutional Biosafety Committee shall include at least one scientist with expertise in animal containment
principles when experiments utilizing Appendix 0 require Institutional Biosafety Committee prior approval.
The institution shall establish and maintain a health surveillance program for personnel engaged in animal
research involving viable recombinant DNA-containing microorganisms that require Biosafety Level (EL) 3 or
greater containment in the laboratory.

 

Accession Number: Special91714 Page: 549 Scan Date: 2014-09?17 COPY

 

 

 

 

 

 


From: Em {cochOTPERrosm}
Sent: Wednesday, April 02, 2008 5:26 PM
To: Ilbi'?? 
Subject: Re: Responses to Request for Additional Clarification: Facility Inspection Report

   

?33142 Vivarium?"Bldg

 

1342

Laboratory and

Did they concur on the inspection report or just the amendment.

Sent from my BlackBerry Wireless Handheld

E. Ph. D.
Associate Director for Science
Team Lead
Division of Select Agents and Toxins
1600 Clifton Road, M5 
Atlanta, GA 30333
Office: 404.?18.2010
Cell:

cuv4@cdc.gov

 

This document is intended for the exclusive use of the recipientfs] named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. if you are not the intended recipientis), any dissemination, distribution, or
copying is strictly prohibited. if you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

 Original Message 

From: rm?: ?We  {cocrcoresnrosan (CTR)

To: icocrcorpeerosm}

Sent: Wed Apr 02 1?:03:30 2008

Subject: Re: Responses to Request for Additional Clarification: Facility Inspection Report Laboratory and



 

Hey dave

?3142 have anymore concerns when he received the responses. We have the
 .. I I 

concurrence letter from aphrs for this amendment so If we are satisfied with the latest responses then we can close out
the inspection report and amendment.

 

 

[misuse

I forwarder was. 2623 email with the responses to

rh?

so she can review them.

      

 

 

 

 

 

 

Sent using BIackBerry

 Original Message 

From: 

Tow-11133" WW . {CDC/ocoorosm

CC: this? (CTR)

        

 

Accession Homber: Specia191714 Fade: 550 Sean Date: 2014?09?17 COPY

Sent: Wed Apr 02 16:48:04 2003
Subject: Re: Responses to Request for Additional Clarification: Facility Inspection Report 33



 

. Laboratory and

 

I am not sure whether or not USDA has additional question or whether you will receive any thing from them. I will
endeavor to find out for you.

. . . 

Sent from my BiackBerry Wireless Handheld



Associate Director for Science

Team Lead

Division of Select Agents and Toxins
1600 Clifton Road, M5 E79

Atlanta, GA 30333

Office: 4043182010

Cell; mus:

cuv4@cdc.g0v

 
 

This document is intended for the exclusive use of the recipient{s) named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientts), any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

 

   

Subject: Responses to Request for Additional Clarification: Facility Inspection Report ?3333342 Laboratory and ?33334

U30. 2523

  

 

Please find attached a copy of our response report to your most recent request for additional clarification for our facility
inspection report [Bldg Laboratory and ?3133142 Vivarium Space]. Also provided as separate files are the HVAC
balance test records as requested.

 

 

ressurespdf? 

Do you know whether or not we may still be receiving additional questions under separate cover from USDA for this
report? Thank you in advance for your assistance with our entity's registration matters.

Respectfully submitted,

Accession Number: Specia191714 Page: 551 Sean Date: 2014?09?17 COPY

 

may:

EBC?'e?i'iters for Disease Control and Prevention Office of Security and Emergency Preparedness Personnel Suitability and
Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-ZZ
Atlanta GA 30333

[biz-i; 3342 USE-E


 

 

 

 

Please visit OSEP Customer Satisfaction Survey
and tell us about your
recent experiences with OSEP.

This document is intended for the exclusive use of the recipient{s) named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls}, anv dissemination, distribution, or
copying is strictly prohibited. if you think you have received this document in error, please notify the sender
immediater and destroy the original.

Accession Number: Special91714 Page: 552 Scan Date: 2014?09?17 COPY

 

 (CDCIOPHPRIDSAT)

 

 

 

  

 

From: -  i= 

Sent: Tuesday, July 29, 2003 4:54 PM

To: ate? this? (CTR)
Subject:

fibre:  I

 

Biodision of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

 

 

 

 

 

  
 
  

 

 

       
 

 

3
?13:75) i
From: Wevant, Rob 
Sent: Tuesda Jul 29, zoos 2:44 PM
To:  2= (coercorpewosm; 2'23: (cocicorpemosm
Cc: .. coercowearosa?r)
mwet 
i concur with opinion. Given that they're in the neighborhood, doing a quick follow-up walk through shouldn't be
a problem.
Flob Weyant
From: ribs-5':  (coercorpenrosaT)
Sent: Tuesda Jul 29, 2003 2:42 PM
Tm   (cocrcorpesrosarl-
Cc: cocrcowsnrosar); Wevant, Rob 
Subject: RE: CDC

I have reviewed the documents sent in reference to CD05 amendment to open the ?u lab in I have the following
comments:

1] In response to 'nquirv about the emergency power incident in CDC states that "there was no emergency
[biz-oi:   
2 Eiidference BFO summaryr response to  

 

   

. June 26, 2008).

However in other locations in these documents, statements including "This disruption and other issues culminated to and
(sic) outa on Friday June 8, (p3 of Facility Maintenance and Engineering Of?ce Report on June 3, 2007
Building Ground Fault Incident) and in the same document on 4 the statements "The building immediater
experienced a and "ma' - - . nce staff quicka responded to the loss of power" clearly indicate that there was
an unplanned power interruption in 3 3?

  
 

I think including the claim that there was technically no emergency power failure even though it is clear there was no
power in the building ma];r be confusing and possibly misleading to non-technical readers.

The purpose of our question was not to haggle about whether the emergency power failed or not but why did 1318 lose
power for a signi?cant period of time and how can we prevent this from happening again?

. The documents provided by CDC indicate that several signi?cant problems were found in the grounding system. The BFO

summary responses indicates that "All corrective action measures recommended as follow-up to the lightning strike
incident have been implemented by 

Accession Number: Special91714 Page: 553 Scan Date: 2014-09?17 COPY

Given this assurance in writing from Geore Chandler, there is only one remaining question that I have. His statement on
the second page of his email response to 3 5 '1 - on June 26, 2008 states "Please note that although there are some
remaining concerns, CCID concurs with this re ornrnendation". Concerns?

 
    

I think that the remaining items were addressed by CDC although we should have a quick walk-though for minor issues
before they go hot in my opinion.

   

I
'iil'ision of Select Agents and Toxins

Centers for Disease Control and Prevention
1600 Clifton Rd NE. Mailstop A 46

AH 53an Cpnr'uin one-no

 

 

 

 

 

 

 

 

 

 

was:

From: 5?5  (CDCICOTPERIDSAT)
Sent: Monda Jul 23, 2003 3:33 PM

To: (?3435? '333'353 (CDCICDTPERIDSAT)
cc: mire: mine: 
Subject: CDC [3:313:42 

Have you had opportunity to review the responses to our additional concerns for the ?13334
time can we get together to discuss our concerns.

 

group. When you have

Thank you,

Accession Number: Specia191714 Page: 554 Sean Date: 2014-09?17 COPY

 

 

 

 

From: 

Sent: Friday, December 19, 2008 11:14 PM

To: this? ?This: licocxcowenxosan (CTR)
Subject: Re: CDC Inspection issues

It will be cover with the letter.

 

 

 Division of Select Agents and Toxins
1600 Clifton Road MS 
Atlanta, GA 30333

 

 

 

 

sap}

This document is intended for the exclusive use of the recipientls) named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

 Original Message 

From: I'ibi?i?i 
To: {cocfcowcexosm}

Sent: Fri Dec 19 19:50:43 2003

Subject: Re: CDC Inspection issues

will

This looks fine. I went back and looked at the checklists today and the inventory issues were not listed only the security
issues were. That is why it didn't get put in the report. I am waiting for to let me know if he wants me to add the
inventory issue to the report and resend it or include it in the report for the January inspection.

Sent using BlackBerry

Original Message 

From: 

  m:3:4 Imus; ?rate; I


Cc: {cocxcowER/DSAT); (cocxcoTPEn/osm}
Sent: Thu Dec 18 113322 2008

Subject: RE: CDC Inspection issues

 

 

 

Accession Nomber: Specia191714 Page: 555 Scan Date: 2014?09?17 COPY

 

According to ?3334 there was an issue identified and a verification visit is scheduled for the week ofJanuary 5. Please
find attached the draft letter for your review.

Thanks,

 

[bjaf?jz I
[bii?l


CDC Division of Select Agents and Toxins 1500 Clifton Road MS ill-46 Atlanta, GA 30333

 

 

 

 

 

 

http:wawcdegovfod/sapf

This document is intended for the exclusive use of the recipientls) named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls}, any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

--d??Original Messagew-n

From: {cocrcorpcerosan

mber 18, 2008 5:01 PM

(cocrcoTPERrosan; (cocxcorpcarosan
-    


Subject: RE: CDC inspection issues

     

 

Based on my review of the inspection report and conversation with the below issue was not cited on the
inspection report. Please confirm if there was an issue identified with the entity's inventory and that a follow up
inspection in January is scheduled. If so, I will draft a letter to the entity stating this. lf not, I need to send a close out
letter.

 

 

Inn?s:

 

 

 

E?uc Division of Select Agents and Toxins 1600 Clift?n ROad MS #46 Atlanta: GA 30333

 

 

 

 

fsapf

This document is intended for the exclusive use of the recipientls} named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

 
 






 

Accession Number: Specia1917l4 Page: 556 Sean Date: 2014-09-17 COPY

Sent: Friday, October 31, 2008 9:56 AM
To: {cot/cowwosmi
Cc: 

Subject: CDC Inspection issues

 

tuner?

 

 

 

Good morning.

 


252aihja-mjgr5:

 

 

 

If you have any further question, please feel free to ask.
Thanks

BTW, please excuse any typos, etc. I am typing this from my BB. :1

Sent from my BlackBerry Wireless Device

Accession Number: Specia191714 Page: 557 Sean Date: 2014?09?17 COPY

Hev

Please see below about the commissioning documents for building

Thanks

 

 

From:  (CTR)
Sent: Tuesday, September 02, 2008 1:19 PM
To:  ee3  rme3 

Subject: Commissioning docs

 

 

 

-- facility verification. Item 29 asked for 

l. ..
252 Eilh 

 first insufficient response letter said for it 20 that DSAT would return for a final I haven't pulled the
inspection folders, but my notes say that their response was very brief, included no detailed testing, and referred to the
prior response for the flu inspection. I had asked ?33?s? if this was sufficient, and he said to note we would do another
walk through.
Please let me know if you need me to pull the folders for more info.

 

 

Accession Number: Specia191714 Fade: 560 Sean Date: 2014?09?17 COPY

 

 

From:
Sent
To:
Cc:

Subject:

Irene) I 

 

 

 


- - tcocrocooxoseet
Thursday, February 07, 2008 1:05 PM

lets: title? 

(CTR)
RE: Select Agent Inspection Response Report

Thank you very are most appreciative of this and look forward to the revised report.

 

.. b4
A 

 

 

 


Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness

Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22
Atlanta, GA 30333

 

[035 3242 U.S.C. 

 



 

 

u-

Please visit OSEP Satisfaction Survey and tell us about your recent experiences with DSEP.

This document is intended for the exclusive use of the recipientfs) named above. It may contain Sensitive information that is protected. privileged, or confidential. and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. 11' you are not the intended any dissemination,
distribution, or copying is. strictly prohibited. If you think you have received this doCurnent in error, please nolily the sender immediately and destroy the original.

 

 

 


Thursda February 07, 2003 1:03 PM
tb'; I CDCIDCOOIOSEP)

     
 

 

 

i=3 1
RE: Select Agent Inspection Response Report

(CDCICOTPERIDSAT) (CTR)

I apologize for the confusion the report has caused. The departures referencing Appendix 0 of the NH Guidelines were
inadvertently left in the report in our haste to get it out to you. We will have a corrected report sent to you ASAP.

  

Accession Number: Special91714 Page: 561

 

 

U. (CWGCOOIDSEH

          


mitt? (ore); .2: (coocoweerosn?r)
miter-:42 tcocrocooroseet; Zambuto, Laura R. (com-anthems}; Keyes, Kathleen [coerccromceocm (CTR)

 

:ct Agent Inspection Response Repert

Scan Date: 2014?09?17 COPY

Kathleen Keyes is the CCID Safety Coordinator. She has raised the following question regarding citations noted in your
inspection report for the Division inspection of thel ibirraizr42U-S-C-was: land IVivarium in Building Can
you provide clarification for us as per the e-mail below??I

Many thanks in advance for your assistance.

 

 

note :42 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

in; 33:42_u_s_c_s


 

 

 

 

Please visit Qgstomer Satisfagign ?imsy and tell us about your recent experiences with OSEP.

This is intended for the exclusive use of the named above. It may contain sensitive information that is protected. privileged. or confidential. and
it should not he disseminated. distributed. or copied to persons not authorized to receive Such information. It you are not the intended recipientis}. any dissemination.
distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

 

From: Reyes. Kathleen 
Sent: Honda Februa 04. 2008 1:15 PM
- cocrocooiosEP}
Zambuto. Laura R. Nicholson. Janet (CDCICCIDJOD)
RE: Select Agent Inspection Response Report

  

Is it possible tor you to check with the National Program concerning the FindingstObservations 9-13? These issues

reference the NIH Guidelines Appendix Cl {see below). The intent of Appendix 0 is to provide guidance for large animals.
such as those that cannot be contained in standard laboratory caging (cow. pigs. chickens. etc.) within the labs. "tiS i

not approriate for the type of animals and containment that Flu (or any of the other Programs) will be using in the 
space in

KK

 

eseatn:

APPENDIX 0. PHYSICAL AND BIOLOGICAL CONTAINMENT RECOMBINANT DNA RESEARCH
INVOLVING ANIMALS

Appendix specifies containment and con?nement practices for research involving whole animals. both those
in which the animal?s genome has been altered by stable introduction of recombinant DNA. or DNA derived
there trom. into the germ-line (transgenic animals) and experiments involving viable recombinant DNA-modified
microorganisms tested on whole animals. The appendix applies to animal research activities with the following
modifications:

Appendix 0 shall supersede Appendix (Physicai Containment) when research animals are of a size or have
growth requirements that preclude the use of containment for laboratory animals. Some 
other types of containment [see Appendix Footnotes and References for Appendix animals:
'leovered in Appenquiy Oizar hose inctudingmbut not'timited to cattle}
swine. ari'd -

The Institutional Biosafety Committee shall include at least one scientist with expertise in animal containment
principles when experiments utilizing Appendix Cl require institutional Biosafety Committee prior approval.

The institution shall establish and maintain a health surveillance program for personnel engaged in animal
research involving viable recombinant DNA-containing microorganisms that require Biosatety Level (BL) 3 or
greater containment in the laboratory.

 

 

 

 

Accession Nomber: Specia191714 Page: 562 Scan Date: 2014?09?17 COPY

 

 

 

 

 

     

From:   

Sent: Thursday. April 2008 10:59 AM

To: this?:  tcoexcorpresrosnn (CTR)

Cc: WW in?? (cocxocoo OSEP)

subject: Facility Inspection: Building  

252301]

Good Morning and

I just came from a committee meeting pertaining to the operation of our Building "and" 
Committee members are seeking an update on the status oi the registration for the Flu Division's application to register 

[bl,3gympiggrtionuof-the and rooms Vivarium. is there any way that you may be able to provide me a status
Ebislitihe registration for the Flu Division?

 

 

Many thanks in advance for your assistance with this request.

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

[bit use. 
 

 

 

 

 

DSEP Qgstomer Satisfaction Survey.

This dneumenl is intended for the exclusive use of the reelpient(s] named above. It may contain sensitive inl'ormulion that is protected. privileged. or confidential, and
it she-old not be disseminated. distributed. or copied to persons not authorized to such information. If you are not the intended reeipientls), any dissemination.
distribution. or copying is strictly prohibited. llyou think you have received this document in error, please notify the sender immediately and destroy the original.

Accession Number: Specia191714 Page: 563 Sean Date: 2014-09-17 COPY

 

 

 

 

From: 

Sent: Thursday, May 01, 2008 6:24 PM

To: licocxcowsgfosag 

Subject: Re: Registration Amendment: ?9'35; Vivarium

 

is this the first notice of this we are receiving?

Sent from my Blackberry Wireless Handheld

E. Ph. 0.

Associate Director for Science
Team Lead

Division of Select Agents and Toxins
1500 Clifton Road, MS E79

Atlanta, GA 30333

Office: 404.713.2010

Cell: 578.451.9956

cudecdcgov

This document is intended for the exclusive use of the recipientls} named above. It may contain sensitive information
that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls], any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

Original Message 

From: were. ll 

To: [bite  (CDCICOTPERIDSAT) 
Cc: I .icocxcowcaxosao; 3   - -  
Sent: Thu May 01 1?:57:33 2008

Viva rium
Good Afternoon

Please find attached registration application amendment documents for Principal Investigator,

requesting registration of ?313342  ace in Building If at all possible, we would like to schedule inspection of
--  in the Building ?1334 Vivarium at the same time inspection of
t??i-?-U-i-l-ding" space is scheduled, May 29 and May 30, 2008.

 

 

 

 

 

- 

 

 

 

   

 

 
  

 

 

      

 

      

   

U30. 262301} I use. 252mm 
[u3rsg5?i3903-Ddf3?3?  - tivarium-Part 5 checklist
[ms Wite?df? Warium-CDPV of 5A_Table -. 
 202301:

523m:

 

 

 

Thank you in- advance for your consideration of our request. Please feel free to contact me if you have any questions
regarding the information submitted in the attachments.

Accession NUmber: Specia191714 Page: 564 Scan Date: 2014?09?17 COPY

Kindest regards,

  

[ffe?hters for Disease Control and Prevention Office of Security and Emergency Preparedness Personnel Suitability and
Select Agent Compliance Br 

1600 Clifton Road, NE, Mail Stop #22

Atlanta. GA 30333

ibji $420.30. 
2 . 

 

 

 

 

OSEP Customer Satisfaction Survey
.

This document is intended for the exclusive use of the recipientis) named above. it may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. if you are not the intended recipientis), any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original.

Accession.Number: Specia191714 Pa?e: 565 Scan Date: 2014-09-17 COPY

 

Irma: I Itbbt?i: I  

   

 

 

      

 
 

 

From:  

Sent: Wednesday, January 30, 2008 3:28 PM

To: this} HW- 

Subject: RE: Potential Exposure at Centers

Thanks

From: this": (coercorpsarosar) (CTR)

Sent: - -- da January 30, 2003 3:01 PM

To: . cocrcorpsarossr}; -  

Cc: (cnqcorpempsm't; ?3 I  
Subject: Potential Exposure at Centers 
Hello,

 

 

901 0? the phone With mi?? Ilia-324? ofrom Centers. There was a potential exposure in the 3 ff 
that?? imployee from en ineering support opened an autoclave that had not completed its run. The autoclave contained

lab. This happened at 1:40p and he is showering out now and will head to the
does not have his full name yet. He is not
Immunized.

 

 

 

 

 

 

 

She said she will send in a form 3.

 

 

 

 

 



Constella Group, LLC
Contractor of the CDC for the Select Agent Program

1500 Clifton Ftoad, NE, MS A-46
Atlanta GA eneqq

 

This document is intended for the exclusive use of the recipientts) named above It may contain sensitive information that
is protected, privileged. or confidential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. It you are not the intended recipientts), any dissemination. distribution, or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

 

 

Accession Nomber: Specia191714 Page: 566 Scan Date: 2014?09?17 COPY

 

 I 

 

 

From: a tcocrocoozossp)

Sent: Monday, March 03, 2008 10:27 AM

To: Irma} 
Subject: RE: APHIS Findings

Many thanks,

 

I

 

Ell_ll.'

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1300 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

33:42 osc. 
252mm. 

 

Er

 

 

 

Please visit USEP Customer Satisfaction Survev and tell us about your recent experiences with USEP.

'l?his document is intended for the exclusive use of the named atmve. It may contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It you are not the intended recipientIEs}, any dissemination.
distribution. or copying is strictly prohibited. if you think you have received this document in error, please notifg.r the sender immediater and destroy the original.

 
 
 

From:  tcocgcorpswosm 
Sent: March 03, 2008 10:26 AM

To: - thirst-:42 U- 

Subject: RE: APHIS Findings

Hi

Yes I will forward those responses on the APHIS.

Thanks

 

 

   

. . -- tottsri't'z 
sent: Monda March 03 zoos 10:22 AM
Tu: (CTR)
Subject: RE: APHIS Findings

Ht

Sounds good--we actually provided a copy of the OHS commissioning documents with our submission on 02t'29i2003, so
wili you be forwarding that response on to APHIS as well? 

 


252mm

 

 

 

Accession Number: Specia191714 Page: 567 Scan Date: 2014-09?17 COPY

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitabitity and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333


252a'ihi..- 

 

E-

 

 

 

Please visit QSEP Sgtistgmer Satisfaction Survey and tell us about your recent experiences with OSEP.

This document is intended for the exclusive use of the recipientis] named above. it may contain sensitive information that is protected. privileged, or confidential, and
it should not be disseminalcd. distributed. or Copied to persons nol authorized to receive such information. It you are not the any dissemination,
distribution, or copying is strictly prohibited. If you think you have received Ihis document in error. please noliiy the sender immediately and destroy Iht: original.

 

From: [by-5:3 ?mii?i (CTR)
sent: .. . I 3, 2003 IDIZU AM

i  (cociocooiosee)

Findings

 

  
  

 

 


 

I spoke to the inspector at APHIS and they would like to have the commissioningdocuments irorn OHS. Also, they said
they would like your responses within two weeks.

Let me know if you have any other questions.
Thanks
 tons; (bits;

 

 

 

 

 

 

Constella Group. LLC
Contractor of the CDC for the Select Agent Program
1600 Clifton Fioad. NE. MS A-46

EA 

 

 

 



This document is intended for the exclusive use of the recipient{s} named above. It may contain sensitive information that
is protected. privileged. or confidential. and it should not be disseminated. distributed. or copied to persons not authorized
to receive such information. If you are not the intended recipient(s). any dissemination, distribution. or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

Accession Number: Page: 568 Sean Date: 2014?09?17 COPY

 

links: I Imus} I 

 

 

From: -  - 

Sent: Thursday. April 03. 2003 8:22 AM

Tm {ch)
Subject: Centers response

Dear 8: 

 

You're probably both too busy to look at this now. but I'm going to be gone the first part of next week so am just writing
this now for you to refer to later! It's going to have to be your call about whether Centers' last response is adequate. There
were only 2 remaining items: the door sign and the commissioning documents.

    
 

For the door sign. their latest statement is that "durin .s agreed" that the specific agent infofentry

Thier argument makes sense to me, that there
a?e?iho specific entry requirements for the anteroom itself. I just wonder why they didn't say this in the first place! We do
have photos of adequate signs on those other room doors.

 

 

 

For the commissioning report. after we were only sent their internal checklist for the new rooms. this last insufficient
response letter asked for "air balancing testing records" to try to make clear what was wanted. What they sent back is 44
pages of raw data with no summary or overall evaluation as to whether the facility design as built works as needed. There
are no tests records sent to us. for example. of whether supply air shuts off if exhaust power is lost -- but it's starting to
seem clear that the reason for that is. it wasn't stated in our letter to send this information. Some of the raw data seems to
me to indicate problems:

1. Pages of the printout labeled page numbers 66-68 seem to record that the required were
often not met. but no remarks were made.

2. The exhaust system pages labeled 73, 7'4, and 80 all have the remark "Bio Seal closed to achieve flow." I don't
know if this is OK or not.

 

Surely the company that did this testing supplied Centers with a formal report summary. 3?3 3 maybe you can interpret
this raw data sufficiently to determine whether an adequate response letter can go out. I just don?t know.

 

bii? 

@ohstella Group. LLC

Contractor of the CDC Division of Select Agents and Toxins
1600 Clifton Fload

MS A46

Atlanta. 30333

       

 



 

 

 



Accession Number: Specia191714 Page: 569 Sean Date: 2014-09?17 COPY

 

 

 

 

 

From: (cocxocooxoseai
Sent: Friday, March . 2009 5:23 PM
To:

   

 (CDCICOTPERIDSATSubject: Fw: DSAT Inspection Report:- Round 2

To address Item ii 45 in the DSAT inspection follow-up report of March 02. 2009, I inadvertently omitted the Vertebrate
Animal ?333342 Practices attachment again. Please see attached for insertion in the Section" of my response
notebook provided to you this afternoon:



ABEL-3
Practicespdf

 

Respectfully submitted.

 
 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

42_u.s.c. 
 

 

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the reeipientis] named above. It may contain sensitive information that is protected. privileged: 0r Elm]
it should not he disseminated, distributed, or copied to persons nol authorized to receive such information. If you are not the intended recipientts). any disset'riittationII
distribution, or copying is strictly prohihilcd. lfyou think you have received this document in error. please notify the sender immediately and destroy the original.

 

 

 

From: Williams, Allison 

Sent

To:

Cc: - - 3'3 
Subject: RE: DSAT Inspection Report: Round 2

  

please find below responses to the forest DSAT inspection report. Let us know if there are additional

 
items that need to be addressed.

Warmest regards,
Allison


Accession Number: Specia191714 Page: 588 Sean Date: 2014?09?17 COPY

16. Required procedures and/or special requirements are posted as appropriate. To provide additional clarification:
entering and exiting procedures are not posted on the doors to the animal rooms at this institution because personnel

are required to demonstrated proficiency in required procedures prior to
access to the space. If. you have to read these requirements as you are enteringfexiting you not considered
adequately trained to enter the space and not granted unaccompanied access. Other special requirements, including
required immunizations, use of respirators and other personal protective measures that may be needed are posted on
the signage.

A copy of the ARB SOP manual book was provided, but a copy of the requested SOP has been attached for
your convenience.

20. A c0py of the ARB SOP manual book was provided, but a copy of the requested SOP has been attached for
your convenience.

A copy of the ARB SOP manual book was provided, but a copy of the requesred SOP has been attached for I
your convenience.

29. A copy of the ARB SOP manual book was provided, but a copy of the requested SOP has been attached for
your convenience. Currently there is no written documentation to support the request for personnel working in
building 15. However, there is documentation for personnel who currently work in building

34. A copy of the ARB SOP manual book was provided. The gloves are disposable. There is no such
indication in the manual book for personnel NOT to wash disposable gloves as they are disposed of after use
which is what the SOP states. This is an industry standard.

36. Attached is the completed wOrk order.

37. A copy of the ARB SOP manual book was provided, but a copy of the requested SOP has been attached for
your convenience.

38. This requirement states this response was received from 
of the work order submission. We did not initiate this work order requeSL

    

Pasted is a response from facility personnel, "For 
labs. For the 
indicators in the form of "tell tails" at the entrance of each individual suites that indicate the presence of a 

positive or negative air flow situation for that area, In addition to the before mentioned local alarm devices,
maintenance personnel are also notified via the building automation system as to the status of air handling units
and exhaust fans in the HVAC control room". If further clarification is needed on this requirement, please
contact Mr. Patrick Stanford 

42. A copy of the ARB SOP manual book was provided, but a copy of the requested SOP has been attached
for your convenience.

44. A date cannot be provided at this time. Currently budgetary constraints preclude immediate replacement of
this equipment.

Accession Number: Specia191714 Page: 589 Scan Date: 2014?09?17 COPY

 

 

Holt. James D. (CDCIOCOOIOD)

    
    

 

  

 

 

sent: Monday, December 10, 2007 8:00 PM

To: Weyant, 
ii"? 

Cc: J- . cecrcoreemo 
I 2)

Subject: I servation

 

[Out of Scope]

 

 

 

Sent from my BlackBerry Wireless Device



From: Weyant, Rob (CDCICOTPERIDSAT)
To: mire: {coercoresalosmh 3'1 i= '1 

cc: Holt, James D. (encrocoorom; {cecrcoressresm};
{cocxcorpsexesm 

Sent: Mon Dec 10 17:55:24 2007

Subject: Re: CDC Observation

     

 

 

We should hold CDC to the same standard that we hold all entities to.

Rob Weyant

Sent using BlackBerry

1
Accession NUmber: Specia191714 Page: 612 Scan Date: 2014-09?17 COPY

 

    

 

From:  (CDCICOTPERIDSATJ .

To: 4v?: the? 

cc: Holt, James D. (cocxocooxool; {cocxcowsaxosmg
  fbi=ei= Itcocxcowsnrosar) (cm)

Sent: Mon Dec 10 15:58:18 2007
Subject: RE: CDC Observation

It has always been my understanding that the Program position on this matter is that any area where select agents and
toxins are stored, even if only for a short term, must be registered. Anyone who has access to select agents and toxins,
can place their hands on such, must be SRA cleared. If an ehtity puts into place a protocol and records for ensuring that
someone from the laboratory who is SRA cleared hands select agents and toxins package to the courier and receives
it from the courier than we have not required them to register the shipping and handling area or personnel. remain of
the opinion that we should not make exceptions for CDC.

 

[Dii??

 

 

 

 

 

Elli'vi?sion of Select Agent Program

Centers for Disease Control and Prevention
1600 Clifton Road, NE, MS A-46

Atlanta. GA 30333

 

From: 
Sent: Monday, December 10, 200? 1:5? PM I


 

635:5" Holt, James D. {cocxocooxooh 
Imus: ?use: (CTR)

Subject:COC Observation

During our inspection of COC, we observed 3 rooms not on the entity's certificate of registration. These rooms are used
for packaging and storage for select agent packages being shipped or received by the entity. The room used for
packaging the select agents we observed biosafety issues sUch as food in the area, procedures that could cause
occupational exposure, and training issues such as individ uils not knowing what to do if a spill occur. The shipping
storage area we observed security issues such as a "secured" storage cage on wheels and non-authorized individuals
accepting select agent packages.

.-t-he--P-re-g-ra) instructed her these rooms did not have to be registered since no select
agents were being stored (long-term storage) in the area. followed up with Mark and he stated he did not remember
relating this information to ?ii-33342 because rooms that stoke select agents should be on the entity's certificate of
registration. I followed up with James Holt regarding any ldgal issues regarding unregistered rooms temporarily storing
select agents and he stated this was a policy call.

 

 

Based on the regulations, "a certificate of registration will  valid for one physical location {a room, a building, or a
group of buildings) where the Responsible Official will be able to perform the responsibilities required in this part, for

2
Accession Number: Specia191714 Page: 613 .Scan Date: 2014-09?17 COPY

specific select agents or toxins, and for specific activities" [42 One could interpret this as packaging and
shipping select agents.

Since this is a policy call that could impact other registered entities regarding shipping areas that may or may not be on
the entity?s certificate of registration, we need assistance on how best to proceed with the inspection report.

Thanks,

 

 

CLEE Division of Select Agents and Toxins 1600 Clifton Road MS A416 Atlanta, GA 30333

 

 

 

 



This document is intended for the exclusive use of the recipient?s} named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipienttsi, any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

3

Accession Number: Specia191714 Page: 614 Sean Date: 2014-09-17

COPY

 

(CDCIOPHPRIDSAT)

 

 

 

 

 

From: Hell, James D. 

Sent: Thurs 26, 2008 1:04 PM

To:  {e-eesememusm; 
Weyanl, Rep ?mi-5? 


 
 

Cc:
Subject: 

 

1 do not have any further comments.

 

Sg?f?'hussday, June 26, 2003 11:40 AM
Weyant, Rob 

O?Connor, Ann E. (CDCICOTPERIOD)
Subject: RE: Please Review: 3&4225 Lab Talking Points 

 
 
 

 

  

 

 

From: Holt, James D. (CDCIOCOOIOD)

 
   
 

 

Sent: Thursda June 26, 2008 8:06 AM
O'Connor, Ann E. 1
Wej'rant, Rob Anasen, Andrea P. I  

 

 

 

 

Paula L. (CDCIOCOOIOD)

 

[013142

Subject: FW: Please Review: Li's?C. s26 Lab Talking Points

 

U.S.C. 

 

 

 

1
Accession Number: Specia1917l4 Page: 615 Sean Date: 2014-09-17 COPY

 

 

Iibll?l

 

 

[hii?l

 

   

   
 
 

ii= (tocrcoweaioss'r Holt, James D. 
--i--(cotrcorpewom; (coercowewoswr)
??iject: RE: Please Review: El Lab Talking Points

   

lib} El]

Please ?nd attached my edits to the talking points. Due to the potential release of these talking points, I have cc'd other
individuals to review the document. Please do not send to GDCAN until you have received a response from them.

Thanks,



?hr ?ivision oF Qel ct Agents and Toxins 1606 Clifton Road MS A-46 Atlanta, GA 30333

 



 

 

 



This document is intended for the exclusive Use of the recipientis) named above. It may
contain sensitive information that is protedted, privileged, or confidential, and it
should not be disseminated, distributed, or topied to persons not authorized to receive
such information. If-you are not the intend?d any dissemination,
distribution, or copying is strictly prohibited. If you think you have received this

 

 

 

 

document in error, please notify the sender immediately and destroy the original. Thank
you.

Sent: Wednesda June 25, 2008 5:22 PM

To:  'cocrcorpsvossr) 

Cc: this (cocicoTPERioo); (cootorpearosm

 

 

 

Subject: Please Review: Lab Talking Points

 

 

use. lab issue. After you clear them, the ?nal will go 

 

Attached are the talking points that I developed on the 
who will do a final review and submit to CDC W.

 

 

 

rprise Communication Of?ce

Coordinating Of?ce for Terrorism Preparedness. and
Emergency Response

1500 Clifton Rd. A45

 

[bills

 

 

 

Accession Number:

2
Page: 616 Sean Date: 2014-09-17 COPY

 

Irene: I Imit?i 

[Out of Scope]

 

 

 

 

From: (cocrom-isarosm
Sent: Tuesday, June 29, 2010 2:49 PM

To: Weyant, Rob (cocropn arosm- -lo t, James D. (coproco oo 


  

(CDCIOPHPRIDSAT -


 

  

 

?Jim WtrcocroeeRare-same 

Subject: RE: ACTION - SR5 update and request [460599)

 

 

 

All,

I think the request was to vet a status update on evaluation ofthe process and there is an anonymous reporting
mechanism. While what has included is great, it may open up more questions than to answer their original
question about DSAT evaluation ol'the TLR process. I think what was Originally drafted will answer the questions and
recommend wejust use that to respond.

Thanks.

lib-?Bil  Irreiel

 
 

CDC Division of Select Agents and Toxins

1500 Clifton Road MS A-46
?tlanfn rte 

 

[bli??

 

 

 


05:! Vision: To be the preeminent resoarcefor the safety and security of'bi'ofpgi'eol agents and toxins.

This document is intended for the exclusive use of the recipientis) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If vou are not the intended recipientis}, anv dissemlnation, distribution, or copving is strictlv prohibited. If vou
think vou have received this document in error, please notify the sender immediater and destroy the original. Thank vou.

 

From: Wevant, Rob 
Sent: Tuesday, June 29, 2010 2:29 PM
 olt, James D. (cocro - this? (cocro  

   
       

  


(cocropnpaxosm;
(CDCTOPHPRIDSAT)
Subject: RE: ACTION - SRS update and request {460599)

1 donit recall using this term, and I don?t recall seeing this term in any of the documents that we sent to GAO.
1
Accession Number: Specia191714 Page: 618 Sean Date: 2014-09?17 COPY

Robbin S. Weyant. 

Captain, USPHS

Director. Division ofSelect Agents and Toxins
Office ot?Public Health Preparedness and Response
Centers for Disease Control and Prevention

Office phone: 4?4-7l 3-200I

Cell phone: 678-ol4-7234

SiprNet: 

 iifitit?if?ff. To rile preeminent  ?e?rigy um! securffv ({{or'ofogfcuf agents emf toxins.
From: Holt, James D. 
Sent: Tuesda June 29. 2010 2:22 PM ..
. birt?(CDCJAT. (CDCIOPHPBIDSAT Wevant.

(cb'cxopnpeios 

Subject: RE: ACTION - SRS update and request (460599)

 

      

   
    

    

 

 

 

 

[Gut of Scope]

 

 

 

 

 

 

Sent: Tuesday, June 29. 2010 PM 
To: this": (cor: UPI-IF DSAT Weyant, Rob  
Holt, James D. I?m-5? 
(CDCIOPHPRIDSAT)

Subject: Re: ACTION - SRS update and request {460599)

  

 

positively impacted public health.

Written Justification for Award (Award Narrative}:

   

. reported between 1930 and

are categdl?y Select Agents. can range from non-specific.
flu-like iliness and undulant fever to systemic infection. multisorgan abscesses. endocarditis. neurological disease. chronic
infection. and death. Diagnostic laboratory workers are freqllently exposed during the manipulation of unknown isolates.

and submission of unknown isolates to reference laboratories often results in multiple laboratory exposures involving the
same isolate. CDC provides guidance for the identification 6i at-risk workers involved in laboratory exposures. a ?ght??gtsc?
post-exposure prophylaxis and serological monitoring of exposed workers. CDC receives notification of potential 
laboratory exposures through three sources: noti?cations t' Division of Select Agents and Toxins Select
Agent Program of the identification or accidental release 0 isolates from microbiology laboratories; notification to
the Laboratory Response Branch (LRB) from Laboratory Response Network laboratories of the
identification of isolates: .s to the Bacterial Zoonoses Branch for assistance on
laboratory exposure incidents and i -. .cases or submission of isolates for identi?cation. The requirement to report
via these separate. multiple routes for notification to CDC c?n result in a failure to identify potential laboratory exposures.

 

. I Cl USE. 
Iln the Qtntee r: accountg? for 24 of a? 

 

 

 

 

 

 

 

  
 

  

 

2
Accession Number: Special91714 Page: 619 Sean Date: 2014-09?17 COPY

exosure evaluation, and assistance for the monitoring of exposed worke 
gb?igreference laboratory and isolate identification and matching by'ihir

ibh'?

resulting in failure to provide appropriate follow-up care and moni

toting of exposed workers.
Action i

 
 

I standardized procedures to provide rapid notification
. isolate identifications or laboratory exposures. This
included referral of reporting laboratories to appropriate health departments, provision of CDC expert guidance on

logical testing at the 

     

 

Sent using BlackBerry

 

 



 

 

 

 

 

 

[bile]
-- we: (CDC capstosar); Weyant, Rob  
Holt, James D. (coctocootoo); 

 

(CDCIOPHPRIDSAT)
Sent: Mon Jun 28 17:45:39 2010
Subject: FW: ACTION - SRS update and request (460599)

All,

Please see below. According to GAO, we stated in our last meetlpg with them over year ago that we would evaluate the

?Witt: recess and provide reporting incentives such as limited immunity. Here is how I would like to respond:

 
 

1. Evaluation of TLR process:

On January 18, 2009, the Select Agent Program published the Select Agents and Toxins The?. Loss
and Release Information Document. The Select Agents and Toxins. The?. Loss and Release Information
Document assists the regulated community by providing examples of the laboratory incidents that need to be
reported to CDC or APHIS. Through twenty possible scenarios, 't describes how the occupational exposure
definition may be applied to incidents that may occur in facilities working with select agents and toxins. On June
15, 2010, CDC and APHIS posted six additional scenarios on our Select Agent website
CDC, in collaboration with APHIS, is currently analyzing
data on select agent releases reported by entities on an Form 3 (Report of Theft, Loss, or Release of
Select Agents and Toxins). Once this analysis is completed, CDC plans to publish the findings in a publicly-
available report and in a peer-reviewed journal. In addition, the Select Agent Program has hosted on an annual
basis since 2008 werkshop series to inform individuals of their legal responsibilities for implementing the select
agent regulations. The last workshop series held on June 15, 20] in Sparks, NV included a session on the ?Best
Practices for Preventing Occupational Exposures to Select Agents."

2. Reporting Incentives

On April 26, 20] 0, CDC and APHIS established a confidential means for reporting safety and security issues associated
with the possession, use and transfer of select agents and toxins. The Department of Health Human Services, Of?ce of
Inspector General (OIG) maintains a hotline that allows individu Is to anonymously report fraud, waste and abuse in all
departmental programs. This hotline is now available to anonymously repon safety or security issues related to select
agents and toxins. 

lfOK, I will send forward.

Thanks,

 

ll:

 


252mm:

 

 

Accession Number:

CDC Division of Select Agents and Toxins

3

Specia191714 Page: 620 Sean Date: 2014-09-17 COPY

1600 Clifton Road MS A-46
Atlanta. GA 3031s

 

ibiiB}

 

 

 

http:wawseiectagentsgovi'
USA l'l's'i'oii.? To be the preeminent resource for the srr?fv and Security (ff-bi'ofogrc'of ogems and i?m?i'rrs'.

This document is intended for the exclusive use of the recipientliil named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. if you are not the intended recipientis}, anv dissemination, distribution, or copying is strictlv prohibited. If 1irou
think you have received this document in error, please notify the tender immediater and destrov the original. Thank you.

Elli-ii 


Subject: FW: ACTION - SRS update and request (460599)

   

Can you respond to Sandi's questions below please?

. ..- 



Ser t: Mondav. luneI 2010 9:56 AM

To;  CIOPHPRIOD)

Cc: . 

Subject: ACTION - SR5 update and request (460599)



 

HIKE:

 

 

 

 



[b'jlj? 2E2aih':

 

 

please let me know if DSAT has any more concerns with the  for the Hazardous
Incidents in Biosafety Labs review. Can you Also take a look at the request below from DSAT
and work with DSAT on a response? Thanks, Kerry, and let me know if you have any questions.

 

GAO Request 

In addition, since our interview with DSAT officials was over a year ago, I would like to
ensure that I have current information about i aspects of the TLR program. In particular,
when we last met with CDC, we asked about currEnt efforts or plans to (1) evaluate the TLR
system and (2) provide reporting incentives, itch as limited immunity. At the time of our
interview, DSAT did not have ongoing efforts er plans in these areas. Is this still the
case? If not, could you please provide details on these efforts?

 

[Out of Scope]

 

 

 

4
Accession Number: Specia191714 Page: 621 Sean Date: 2014-09?17 COPY


262st

 

CIOPHPRIDSAT)

use. 262a


 



Itbil?l I libii?l I 

 

 

 

  

 
     
 

 

From: 

Sent: - ll er 21. 2010 1214? PM

To: - 
Subject: RE: SA inspection 

   

  

case since he has had previous access and has provided training for that space, it is just a refresher for
ch should be provided by the program prior to inspection. However. for building 
access or training or entered the labs while they are hot. full training as described will be required. We just cannot deviate

from that which I am sure he can appreciate.

 

   
   
  

  
  

  

 

 

 

        

 

Thanks
El

From: the: (cocioPHPRiosriT)

Sent: Tuesda Setember 21. 2010 12:35 PM

 '33  .. CD libli?l 

Cc: fbiliiP-S-C- to?? - :1 
[we their? - i


Subject: RE: SA inspection 'Ui;

 

 

 

 

 

03.133912 U30. 262a
[hjz

 

 

  

  
  

this?? will be the only DSAT requesting entry into the lite?  ..
laboratories for the October 2008 DSAT inspection. He has inspected the  
operational.

 

 

last entered the 
laboratories prior to them deft

 

 

 

 

iblt?}

 

 

Accession Nomber:

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

[Ammo as ?tl'l'i't?t

inns:
DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents.
hosts. and vectors of human disease to protect the public health in the united States.

 

up

Please consider the environment before printing this e-mail. This docu nt is intended for the exclusive use of the recipient named

above. It may contain sensitive information that is protected. privileged. pr con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

 

(CDCIOCOOIOSHE)
1

Specia191714 Page: 623 Sean Date: 2014?09?17 COPY

 

Sent: Tuesday. September 21, 2010 11:10 AM I 

Tu: coc 
DSEL - sites?  uses
a with}


Subject: RE: SA inspection requirements--

 
 
   

 

  
   

 

 

 

 

 

         

     
 

 

 

 

   

Person entering thel [Mi-"342 ?5352523? game; lhill be required to view the OHS training video and have a
walk through by OHS of the outer corridori'checklist. Once that is complete the person should be escorted by a program
speci?c trainer and introduced to the practices and procedul?ies of entry and exit of that space. The program at this point
must make the call regarding their training and sign off. ThiE is program SA space and they control who goes in and out.

Once signed off by program they can enter the space for the inspection but obviously they would have to be escorted by
an approved user at all times.

[it has provided a training form on line for them: Sections i. II and lit should be completed prior to the

ispection rocess. I do not want the inspection process td.be the first entry or introduction of entry and exit procedures
for the So some advanced scheduling for training would be required.

 

Thanks

 

[0:131:42 U.S.C. 252mm
U.S.C. 

 

 

 

USE. 2523[h}

 

in: 3142   
of Health and Safety
Centers for Disease Control and Prevention
1600 Clifton Road

Eli-lante- FA 1111?)?!

 

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have provided.

. a vaccine witi?lin 3 years. The safety manuals for the
 to review.

      

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Please clariiy what training is required by OHS for inspectioi?i of the laboratories, and whether it will be provided at
the time of inspection or need to be scheduted in advance.

Thank you.

2
Accession NUmber: Specia191714 Page: 624 Sean Date: 2014-09?17 COPY

 

[bit?l

 

 

 

Duvusnon ot Seiect Agents and oxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta. GA 30333

ring-rs;

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents.
hosts. and vectors of human disease to protect the public health in the united States.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

 

    

. . 


Subject: RE: SA inspection 33?: if:

 

     


ibis-?2 this?? Em;

 

   

 

Thank you for the additional input.

Sincerely.

 

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252mb:

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Campus
1600 Clifton Road1 NE. Mail Stop A-22

Atlanta. GA 30333




 

 

 

 

 

 

 
 
  

by 
In 4 H's. --   
new} {bits} I 252mb}

  

 

 

3
Accession Number: Special91714 Page: 625 Sean Date: 2014-09?17 COPY


Subject: RE: SA inspection requirements"-

 

safety comments below. Entering any hot laboratory in the 
. -  mentaned for 15. So in keeping with requirementsf 
lab in I ande knowledge training video checked tour by OHS 

accompanied by a approved user after having being remains of the rules and features in case of problems)

  
 
   

 

 

 

Also there is vaccination requirement for entering That is any space shared with the program
will require vaccination every 3 years.

 

Thanks

 

 

i=1  
Ser t: Thursdav. Seo ember 16, 2010 9:41 AM

 

 

 

 

 

 

 

      

 

.
Cc:  'mmgU-S-C?
-- "i mm tum-i2 (cocrocoorosaE); ??at . Em 25am;-

     


Subject: FW: SA inspection requirements--.  

 

 

 

Good Morning
Please see e-mail below from
our entity.
Sincerely,

?3 
252arh'-.

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1000 Clifton Road. NE, Mail Stop At22
Atlanta. GA 30333

It 1334420513. 


 

 

 

 

 



       
 

Thursday, - tember 16, 2010 9:29 AM
[bi-age aware" I 
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sewed: SA inspection requirements

 

Here the requirements for laboratory inspectors.

4
Accession Number: Specia191714 Page: 626 Sean Date: 2014-09?17 COPY

 

[0th of 

 

 

 

For corridor: no

252mm

Accession Number:

 
  

Specia191714

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Page:

627

vaccine requirements. OHS ang manager ao roval
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Scan Date: 2014?09?17

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From: - - . (CDCIOCOOIOSHE)

Sent: - I. -- ber21.2010 12:46 PM

To: it. 1- . 
Subject: RE: SA inspection 

 
   

 

In case since he has had previous access and has provided training for that space, it is just a refresher for
Building which should be provided by the program prior to inspection. However. for building he has never had
access or training or entered the labs while they are hot. full training as described will be required. We just cannot deviate
from that which I am sure he can appreciate.

Thanks

 

 

     
 

 

 
   

  

 

 

 

 

- .  .  . 
(co (coerciomczveo); lemes. (cocrocooxosntz);  "?rearm 


Subject: RE: SA inspection  
3[ I

 

 

 

 

 

 
 

 

 

I this? will be the only DSAT requesting entry into the - . .
laboratories for the October 2008 DSAT inspection. He has inspected the l??l aboretories prior to them bei'i?i'g'?'?'aihir
operational.

[b HE 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS ilk-46

?flanl'a Fi? Qn'I'l'Zt

 

   

 

 

 

 



 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents.
hosts. and vectors of human disease to protect the public health in the Llpited States.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

 

 

(sociocoorosna

1
Accession Number: Specia191714 Page: 628 Sean Date: 2014-09-17 COPY

     
 

 
 

      
  
  

 

   

 

 

 

   

 

Sen

To:    - 1- - 
Cc: seizes-C-  r:  . .- 
. (cocrocoorOSHE);
ham

Subject: RE: SA inspection requirements-- 

 

 

 

Any person entering the high containment labs. Will be required to view the OHS training video and have a
walk through by OHS of the outer corridorfchecltlist. Once that is complete the person should be escorted by a program
specific trainer and introduced to the practices and procedui?es of entry and exit of that space. The program at this point
must matte the call regarding their training and sign off. Thib is program SA space and they control who goes in and out.
Once signed off by program they can enter the space for the inspection but obviously they would have to be escorted by
an approved user at all times.

 

has provided a training form on line for the Sections i, ii and should be completed prior to the
inspection rocess. I do not want the inspection process Id be the first entry or introduction of entry and exit procedures
for the So some advanced scheduling for training would be required.

Thanks

 

WA (b38142 use. 252mm  I

??f?ty and Occupational Health Manager
Office of Health and Safety

Centers for Disease Control and Prevention
1600 Clifton Road

Atlanta. GA 30333

is: 3342 use. 


 

 

 

 

 

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Subject: RE: SA inspection requirements-"I ermineu.s.c.?2a2am: 



 

use. at 262mm prg?mmg

Thank you for the information you and have provided.



 

 

 

 
 

accine within 3 years. The safety manuals for the user groups will
to review.

Please clarify what training is required by OHS for inspectioH of the laboratories, and whether it will be provided at
the time of inspection or need to be scheduled in advance.

 

2
Accession Number: Specia1917l4 Page: 629 Sean Date: 2014-09-17 COPY

 

[bll?]

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE M3 A415
Atlanta GA some

 

traits}

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents.
hosts. and vectors of human disease to protect the public health in the united States.

Please consider the environment before printing this e?mail. This document is intanded for the exctusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential, and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. if you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

 

From: they: [him 
Sent: Thursda Seternber 10.r 2010 9:5?
To; 11'  . cocrocooroSHE?252aihl 1 
i=1  Holmes. (cocrocooros
 

Subject: RE: SA inspection requirements- 3352-3??

   

 

     
 

    

 

     

 

 

 

 

HE



 

 

 

 

 

Thank you for the additional input.

Sincerely.

 

[0367.242 U.S.C. 2623??!

 

 

 

Lienters tor Disease control and Prevention
Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

[0:133:42 U30. 2623ih}

 

 

 

 

 

From: lioli33:42 I thirsty-12 

 

 

warez use. 2523
lei-gas thew? U-S-CI- 
[bi-[311142 (cocrotomczveo); lemefn (cocrocooirOSHE); 

 

 

 

   

3
Accession Number: Special91714 Page: 630 Sean Date: 2014-09?17 COPY


Subject: RE: SA inspection requirement U?g??za

[hr

 

 

 

 

To add to safety comments below. Entering any hot laboratory in the basement will require site
specific training. These would be the same as mentioned for 15. So in keeping with ..safety requirements for
entering an active lab in andror mannal knowledge training video checked tour by OHS 
accompanied by a approved user after having being remaidb of the rules and features in case of problems}

 

Also there is vaccination requirement for enteringl librt3r42U-S-0-5262ath} IThat is any space shared with the program
will require vaccination every 3 years.

Thanks

 

 

 

From: his: - El 
Sent: Thursday, Setember 161r 2010 9:41 AM
To: Iib}i3i:4 [b31314 
cc: libli3324 it:j:3:4 [bier-:42 I 
wig?? ?3?33? (CDCIOIDINCZVE 


Subject: SA inspection I [bii33-z42 I

 

   
 
  

 

  

 

 
 
 

 

 

 

Good Morning - 33 it

Please see e-mail below from regarding the ore-entry requirements for the registered locations at

our entity.

Sincereiy,

 

[bi-$342  I
?2o2a[h_: 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

rm 


 

 

 

 

 

 

From: mus: (cocrotomczveo)
Sent: Thursda September 16, 2010 9:CG. 252mm (CDCIOIDINCZVED)
Subject: SA inspection requirements

 

 

 

 

Here the requirements for laboratory inspectors.

4
Accession Number: Special91714 Page: 631 Sean Date: 2014-09?17 COPY

 

ut of Samuel.  

 

 

 

  

- vaccine requirements. OHS aqfl manager . . . at
?as OHS and Program authorization (ghould not involv  manager)

 

 



 

[bit?l

5
Accession NUmber: Specia191714 Page: 632 Scan Date: 2014?09?17 COPY

 

 

 

     

 

  
seat: Monda . Deoem or 12, 2011 5:13 PM
To, i= IEI 
Subject: RE: Additional info and interviews



That sounds like a better schedule them for that time. How much time would you like me to allocate per

interview?

 

 

42  

 

987nm"

 



I

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1000 Clifton Road, NE, Mail Stop A-22

Allanta, GA 30333

 

'33142 U.S.C. 

 

 

 

 

 


December 12, 2011 5:10 PM
m,  

RE: Additional info and interviews

  
      

udnlh

I don?t think we can do these interviews tomorrow. What about Thursday morning beginning
at 9:30?

 

(mom use. 

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

mire..-

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

From: 
SE mber12, 2011 5:01 PM
To ESEathMDitBi 

Cc: 
Subject: Additional info and interviews

 

 

 

1
Accession Number: Special91714 Page: 633 Sean Date: 2014-09?17 COPY

Here is a list of additional documentation that we will need from your facilities group:

1. Preventative checklist ?we are reuesting March and September for all Suites. We have only received
May. Months do not match those requested.


2. EDS cook tank cycle data -- These data are exactly what we need however we will need more dates. We only
received a single date for each of the three tanks.

3. Incident Log?March and September
4. Schedule for Preventative Maintenance on Air Handlers.

5. Schedule for Preventative Maintenance on EDS.

Names for interviews:

 

 

 

 

 

 

 

 

 

 

Animal Care technician

Person who replaced lib} [breeze

i Couple of technicians from an
Stanford

 

 

 

I am not sure we can accomplish all these interviews tomorrow afternoon. I think and I will be tied up for quite
a while in the lab and that may run into our time slot in the afternoon to help conduct these interviews. I am not sure
how to access that potential complication. We can conduct interviews on Thursday, as we will have a less restrictive
schedule then. and will be available tomorrow as planned.

 

Thanks,

 

  

ibli?l
Division ofSeiect Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and PrEvention
1600 Clifton Road, NE MS A-46
Atlanta, GA 30333

I L. -- I

In? .

 

Mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents, hosts,

and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, 0r confidential, and it
should not be disseminated, distributed, or copied. If you think you have received this document in error, please notify the sender immediateiy and destroy the
original, thank you.

2
Accession Number: Special91714 Page: 634 Sean Date: 2014-09?17 COPY

 

Irma: 



 

 

 

 

 

 

 
    
 

 

    

 

 

 

 

From: no.2. 

Sent: Thursda A ril 26. 2012 ?:59 PM

To:  

Co: the? lie-5': - i -
[bar-51: (CDCJOPHPRIDSAT):  


Subject: Re: follow up to 4r25r2012 meeting

 

We will be working to generate the information requested and will provide it as soon as possible.

Best regards,

 

 

.  i 

Sent: Thursday, April 26, 2012 06:40 PM

To: Ilbj:l3j::42 lfbj:[3j::42 I  

Cc:  
Subject: follow up to 4f25!2012 meeting

 

 

 

 

Based on our discussions yesterday, as part of our information collecting process, I would like to
request your help arranging interviews with the following people:

1) libjzl?l Ilibll?l I

2) Dr Nathaniel Powell

 

3) 3-4 ARB workers that have duties in this area

4) the members of OSHE and/or BFO who participated in the most recent HVAC functional
testing of this lab (limit to 3-4 staff members from each). We'do not need to interview supervisors
at this time.

We would like to meet with these individuals separately next week. If possible, we would like to
schedule 15-20 minute interviews in the early afternoon (1-2:30 pm) any day next week. Of
course, we will try to accommodate any schedule conflicts. Depending upon the final number of
individuals, We anticipate being able to finish by Wednesday. But should the need arise, we can
interview people later in the week. Please send the names and proposed times that
these people can be available.

 

In addition, I would appreciate it greatly if you could provide me with the following
information/documentation;

1) the date when this lab was last tested for proper airflow,

1
Accession Number: Specia191714 Page: 635 Sean Date: 2014-09?17 COPY

2) any documentation of this test,
3) the date when the lab was decontaminated prior to the reported airflow deviation,

4) any documentation regarding the decontamination procedures and verification of these
processes,

 

[b36142

5) specific entry requirements for the Us? suites when the labs are hot and cold,

2522.013;

 

 

 

6) specific entry requirements for the clean corridor areas outside-of the lab suites

My apologies if you have alreadyprovided any of this information in the documents currently
under review.

We would also like to conduct a series of relatively simple tests of airflow patterns on this lab and
several others in the same general area next week. We propose to stand outside of the
containment space in the clean corridor with smoke sticks and verify the direction of airflow while
the inner door inside the containment space is opened and closed in the same manner that
caused the anomaly observed by the visitors. We are not requesting any failure scenario testing,
any HVAC system manipulations or any other mechanical procedures to be performed during
these tests. We will need someone from either ARB or OSHE to simply open and close the inner
door for various time intervals while we observe the smoke patterns from outside of the lab area.
These activities should provide useful information about the current status of the ventilation
system function.

if possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1500 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

 

 

 

 



 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

2
Accession Number: Specia191714 Page: 636 Sean Date: 2014?09?17 COPY

 

 

  

   

 

  
  
 

 

 

 

 

 

 

 

 

From: -- -- ?133142 

Sent: Wednesda May 02, 2012 3:13 PM

To; the -  


Cc: ?13'163' (CDCIOPHPRIDSAT 3 3i 3' I 9*
insist-12 3   3' 
?33?s? . (CDCIOPHPRIDSAT)

Subject: Requested Documentation

 

Per your request of April 26, 2012, the following documentation is provided with this submission:

 

1) The date when this lab was last tested for proper airflow by BFO was December 21, 2011. OSHE
verified proper airflow on January,' 9, 2012.

2) Any documentation of the first two ?pdf? attachments are provided by the third 'pdf? is the OSHE
verification of airflow on Januarv 9, 2012

. .
l?'iwariurrl Dec 11 Vivarium
F- 1 012.de

df
3) The date when the lab was decontaminated prior to the reported airflow deviation {December 5, 2011 using
Spor-Klenz). The OSHE procedures for Spor-Klenz decontamination are provided below.

 

@24-

   

LABORATORY
SURFACE DECOM. .

The specific entry requirements for the suites when the labs are hot and cold as well as for the clean corridor
areas outside of the lab suites will be forwarded under separate cover later this afternoon.

Best regards,
. 

 

 

Fr

ii-I 
252ath

 

 

 

centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

[nd 
 

 

 

 

 

Accession Number: Specia191714 Page: 637 Sean Date: 2014-09-17 COPY

 

lists: I little"; I (CDCIOPHPRIDSAT)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

From: - - - -- 

Sent: Tuesda Aril 03, 2012 2:25 PM

To: this: ti

Cc: ?'33 ?m5? Vii"?
this: thins: 

Subject: RE: CDC Reaponse to Facility Inspection Report: Special Pathogens Branch Inspection

Good Afternoon

In response to your request for clarification and additional information regarding our Viral Special Pathogens Branch
response report the foliowing is provided by

Attached arethe manual and the copy ofthe email sent to each users with the modifications. The changes have also
been mentionned during the last "bells and whistles? {training session).



for users Manual March
2012 - 

5 Requirement: The biosafety and containment procedures must be sufficient to contain the select agent or toxin 
physical structure and features of the entity. and operational and procedural safeguards). [42 CFR Perform all
procedures to minimize the creation of splashes andlor aerosols. 

Observation: At the time of inspection, lab personnel were not clear on the possession or location of rotor keys for the
removal of microcentrifuge rotors to allow for the loading and unloading in primary containment (BSC). Please verify that
all microcentrifuges use sealed rotors and that they under primary containment. In addition, the Beckman
Coulter Allegra 12R swinging bucket centrifuge in did not have bucket lids. Please verify that this centrifuge
has been equipped with the proper equipment to prevent aerosol releases outside of primary containment.

Response:

The microcentrifuges are used with an aerosol guard on the rotor. The rotor keys, for the removal of the rotor, have been
attached to each the microcentrifuge to allow for the loading and unloading of the rotor in primary containment.

The safety manual has been modified to reinforce the proper use or these microcentrifuges. {section 14.2 A Beckman
Ultracentrifuge and Beckman highspeed centrifuge, each fitted with HEPA filters, are located in a room of each
laboratory suite. Maintenance is performed as needed by staff or by Beckman representatives or contractors
authorized to enter the Tabletop centrifuges [with aerosol guarded centrifuge buckets} and
microcentrifuges (with aerosol guarded rotor], are also located in each laboratory suite. Rotors for the
ultracentrifuge, highspeed centrifuge, and microcentrifuges should be loaded and unloaded under primary
containment (BBC). Aerosol-guarded buckets for the tabletop centrifuge should be loaded and unloaded under
primary containment 

The Beckman Coulter Allegra bucket lids with the different tubes carriers) are present in the drawers below the
tabletop centrifuges.

10 Requirement: The biosafety and containment procedures must be sufficient to contain the select agent or toxin 
physical structure and features of the entity, and operational and procedural safeguards]. [42 CFR All
manipulations of infectious agents must be performed within a 380 or other primary barrier system. 


Observation: At the time of inspection. lab personnel were not clear on the possession or location of rotor keys for the
removal of microcentrifuge rotors to allow for the loading and unloading' in primary containment (380}. Please verify that
all microcentrifuges use sealed rotors and that they are opened under primary containment.

Response:

I 1
Accession Number: Specia191714 Page: 638 Sean Date: 2014-09?17 COPY

The microcentrituges are used with an aerosol guard on the rotor, The rotor keys, for the removal of the rotor, have been
attached to each mlcrocentntuge to allow the loading and unloading in primary containment.

The safety manual has been modified to reinforce the proper use of these microcentntuges (section 7.4.2 A Beckman
Ultracentrifuge and Beckman highspeed centrifuge, each ?tted with HEPA filters. are located in a room of each
laboratory suite. Maintenance is performed as needed by staff or by Beckman representatives or contractors
authorized to enter the Tabletop centrifuges {with aerosol guarded centrifuge buckets} and
microcentrifuges (with aerosol guarded rotor], are also located in each laboratory suite. Rotors for the
ultracentrifuge, highspeed centrifuge, and microcentrifuges should be loaded and unloaded under primary
containment Aerosol-guarded buckets tor the tabletop centrifuge should be loaded and unloaded under

primary containment 

Let us know if you need any additional information.

Best regards,
[bills-12

 

 

[Elsinz  I
for Disease Control and Prevention
Select Agent Compliance, Royhal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

[33:42 uses
252%;

 

 

 

 

2 .
Accession Number: Page: 639 Sean Date: 2014-09-17 COPY

 

lea-,- ?we: 

 

 

 

From: 1= =1 

Sent: Thursda February 02, 2012 7:44 AM

To: W42 {0 ocroenpnrosnn

Co: I so: CDCIOPHPRID 

 

 

leis?- Zambuto, Laure R.

Subject: RE: TLR Report: Exposure Incident

Thank you, 9332 we appreciate it.

Best rega rcls,


 

 

I
Cneannters for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Ciifton Road, NE, Mail Stop A-22
Atlanta. GA 30333


252mm,"

 

 

 

 

 

 

 

 
 
 


uary 02, 2012 ?:36 AM
- 3
[(cocroPi-Ipnrosm; -  1
Subject: RE: TLR Report: Exposure Incident

  




 

 

Good Morning 3 3'3 31

is a USDA only agent, vour Form 3 wili be referred to APHIS this
I will keep you in the loop ifthev have any questions.

in: (3.316 

2E2?ih]

  

- fbi[33:42
Theft, Loss and Release Coordinator
Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS A46
Atlanta, GA 30333

[ole-:42 use  . I
2523th

 

1
Accession Number: Page: 640 Sean Date: 2014-09-17 COPY

 

[Irene uses.  
2 b23[l?li

e-mail Form 3 to: form3@cdc.gov



DSAT Vision: To be the preeminent resource for the safety and security of biologicai agents and toxins.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged, or
confidential, and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the
intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

 

 
  
  


many 01, 2012 3:34 PM
To: . ibj:[3j::4 03:13:15.2 
Subject: FW: TLR Report: Exposure Incident

  

(cociopHPRiDSAT); (CDCIOPHPRIDSAT)

 



at 

[b

 

See attached TLR from Centers for the ferret bite yesterday.

 

From: Martin. Diane 
abruary 01, 2012 3:29 PM


. Zambuto, Laura R. 
[bi-?33142 ?13314
Subject: TLR Report: Exposure Incident

 

           

Please find attached the TLR Form 3 being submitted in accordance with reporting requirements along with the OSHE
Worker Injury Management System investigation Report for the January 31, 2012 potential exposure incident as
described in ?3313*? . email below.

 

I mite:- 
?ee-i rim-n 1 mm mm" Icite: OSHE incident investigation 

[b3 33:42   
pectin-.1

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop 
Atlanta. GA 30333




     

 

 

 

 

 

 

 

 

2 
Accession Number: Special91714 Page: 641 Scan Date: 2014-09?17 COPY

 

 

From: ragga;  

Sent: Tuesday, January 31, 2012 1:42 PM

To (CDCIOPHPRIDSAT)

Zambuto, Laura R. ?1:34.930- 
- i i? ?1393142  D. Frazier, Rodrick 

     

   

Subject: TLR Report: Exposure Incident

 

[b}[3}242 U.S.C. 252aih] I

 

 

    

252mm .
Centers for Disease Control and Prevention

Select Agent Compliance, Reybal Campus
1600 Cli?on Road, NE, Mail Stop JEN-22

Allanta. GA 30333

 

'Er'

3::42 
 

 

 

 

3
Accession Number: Specia191714 Page: 642 Scan Date: 2014-09-17 COPY

 

 

 
  

    

         
   

 

From: - 

Sent: 2011 2:2? PM

19(CDCIOPHPRIDSAT) (CDCIOPHPRIDSAT)

Subject: RE: Inspection Agenda

Thank you, 1 appreciate it.

 

I see where i 3 has requested training occur pre-entry training {to include review of the videos) from 1:00 
2:30 pm. on Monday. The location states Roybal 2202, so I?ll need to confirm the building location with him. May we
alter the schedute to conduct the in-brief and then include review ofthe facility support locations in the morning?

Best regards,

 

[43:33.42  I
?2 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

E-


252-3111; 

 

 

 

 

 

From: this:  
Sent: Friday, December 0?31,r 2011 2:09 PM
mi? 
Cc: [yr-B's Imrcocrompwosm); 
I was: -
Subject: Inspection Agenda

     

 

Please find attached our tentative schedule for next week. Please note that on Monday afternoon we will need your
specialistis} available from both facilities management and security to accompany us as we split up to assess both areas.
Tuesday afternoon we plan to conduct some interviews in the topic areas of facilities, security, research science, and
animal husbandry, however I don't have specific individuals identified as of yet. I will supply you with those names by the
COB Monday.

We will see you Monday morning about 9:00am in the lobby of Building Have an enjoyable weekend.

File: CDC inspection schedulexlsx 

1
Accession Number: Specia191714 Page: 646 Sean Date: 2014?09?17 COPY

 

[1(33142 U.S.C. 

    

 

Division ofSeiect Agents and Toxins

lSiffice of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS int?46

Atlanta GA some


ensign-r-

 

 

 

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged, or confidential, and it
should not be disseminated, distributed, or copied. If you think you have received this document in error. please notify the sender immediately and destroy the
original, thank you.

. 2
Accession Number: Page: 647 Sean Date: 2014-09-17 COPY

 

 

CDCIOPHPRIDSAT)

 

 

   

   

 

 

From: .. 

Sent: Tuesda December13.20112:38PM

To: we 

Co: (CDCIOPHPRIDSAT)
Subject: RE: This Afternoon?

 

We?ll plan on starting the review of the- Program records then tomorrow morning. We can plan on meeting in
the Lobby at 9:00 a.m.

Let us know if you have anv additional questions.

Have a nice evening!

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop A-22
Atlanta. GA 30333


 

 



 

 

 

 

 

From:  

Sent: Tues, If mber 13, 2011 PM

To: rig?lee Lisa-.615 252.. 

Cc: [his - i=1 2
Subject: RE: This Afternoon?

   

 

 

 

 

(CDCIOPHPRIDSAT)

 

and I have completed our document review of Group, Viral Special Pathogens Branch. Therefore, we will
not'be reviewing any additional documents this afternoon. At the - resent, we are in our office compiling our notes and
thoughts in those regards. Our next to start our review 0 In --  - b.

  

suggest otherwise.

        

 

Thanks in advance for all your help and continued support from our friends in Building [El 2 i. and bevond.

1
Accession NUmber: Specia191714 Page: 648 Sean Date: 2014-09?17 COPY

 

   

From: - 3? 

ecember 13, 2011 1:41 PM
To: . 
Subject: This Afternoon?



 



113:1;

Will you be conducting any additional a erwork review this afternoon? If so, please let me know and I will make
a

Program records.
2 ?2alh}

Best regards,

 

:11 
252m:  

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

33:42lu_s_o_?
2523:1113. 

 

 

 

 

2
Accession Number: Specia191714 Page: 649 Sean Date: 2014?09?17 COPY

 

I [03:53 (C DCIOPHPRIDSAT)

 

 

   
   

 

 

 

 

 

From: 

Sent: Wednesda December14,20117:08PM

To: WI: 

Co: was  


Subject: Tomorrow's Interviews

Please see below for the tomorrow morning's interview schedule:

Location: Building 18, 3137 Conference Room



    

 

9:30 am. 10:00 am. Paul Probst 

1000 am. - 10: 45 am. Program Pl}
10:45 am. - 11:30 am. 333 3' Program)
11:30 pm. Ivan Branch [Four Seasons)

Location: Building 18, 1? Floor Conference Room

Interviewers:

9:30 James PedonelOSEP}
10:30 am. 11:10 a.m. Imiil'?l Hm?? I [Animal Resources Branch}

11:15 am. Noon I ?053 IlAnirnal Resources Branch}

 

 

The exit briefing is scheduled for Building Room Wits-2523 The schedule will be as follows:

1:00 1:30 pm Viral Si ecial Pathogens Branch I more: I

1:30 - 2:00 pm  Program I 03:53 I I

2:00 - 3:00 pm Discussion of Reportable Incidents

Please let me know if anv changes are necessary to this schedule.

Best regards,

 

3.3142 
202arh?
Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus

. 1600 Clifton Road. NE. Mail Stop 
Atlanta. GA 30333

i 314205.0- 5
2 62am: 

 

 

 

 

E-

 

 

 

1
Accession Number: Specia191714 Page: 650 Scan Date: 2014-09?17 COPY

 

 

     
 

 

     
 

      
   
  

     
   

 

 

 

 

From:   

Sent: Wednesda March 14, 2012 10:34 AM

To:  Eltc-oc-ioeHeR-tose?I?  



oc: toocrommcezm- tr:   
  
-- static, 3   


Subject: CDC Response to Facility Inspection Report: Special Pathogens Branch inspection

Good Morning I

 

Please find attached the CDC Response Report to the Division of Select Agents and Toxins Facility Inspection
Report of our Special Pathogens Branch laboratory in Building

of:

coc Response osnr FEDEX Copy see March Incident
Coyerletter-SPB  SPB response to Dece. .. Response log.do. ..

  

Respectfully submitted,

 

'Er'

 

 





 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

ion }:42 use. 
 

 

 

 

.
Accession Nomber: Specia191714 Page: 651 Scan Date: 2014?09?17 COPY

 

(CDCIOPHPRIDSAT)

 

 

    

 

   

 

From: . 

Sent: .Tuesda March 2012 2:59 PM

To: We (be: 

Cc: mpg-2m pleas: ocroromcezro}; (CDCIOPHPRIDSAT)
Subject: RE: Inf-5:19 Suit Information Request

 

 

 

Thank you for your quick response to our request for additional clarification.

Best regards,

 

    



Centers for Disease Control and Prevention
Select Agent Compliance, Royba! Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

[on 


 

 

 

 

 

 
 
 
 

  

u. ch 20, 2012 2:57 PM

(cocroromcezm);  

 

 

 

Imus: I libizr?ii II   

(CDCIOPHPRIDSA)
Subject: RE: Suit Information Request

 

We are looking at PPE issues refated to suit use.? it is a simple data collection request. All other entities have
responded to the same request.
Thanks for your help.

 

From: Imi-?gigt?g?zal 
Sent: Tuesda March 20, 2012 2:47 PM

To: jun-IE: . (cocroeHPRrosnr)
Cc:   i=  (cocrororncezro)
Subject: Suit Information Request

  
     

 

 

1
Accession Number: Specia191714 Page: 652 Sean Date: 2014-09?17 COPY

Good Afternoon

Yesterday I sent an additional request from one of our registered programs for more specific clarification on your
request about the positive pressure suit use in our laboratories. I

QR?v-irhi

 Ifor Building has written me indicating that programs met with OSHE this afternoon
aUriEl'have more questions regarding the official DSAT request.

     

 

Please provide response to the additional questions as forwarded from 95:51:33? 

 

1. What is the purpose behind this request?
2. How will the information be used and will additional requests be forthcoming?
3. What other institutions besides CDC has DSAT sent this request to?



Many thanks in advance for your assistance in addressing these additional concerns:

Sincerely,

 


Guam-Hers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 


252m; 

 

 

 

2
Accession Number: Specia191714 Page: 653 Sean Date: 2014-09?17 COPY

A

 

   

'13} 

 

Division ofSeiect Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE M5 

Atlanta, GA 30333

 

?in,

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated, distributed, or copied. If you think you have reteived this document in error, please notify the sender immediately and destroy the

original, thank vou.

4
Accession Number: Specia191714 Page: 654 Scan Date: 2014-09?17 COPY

 



..


OSEP Customer Satisfaction Survey.

This document is intended For the exclusive use ofthe recipient(s) named above. It may contain sensitive infonnation that is protected, privileged, or confidential. and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. if you are not the intended recipientls). any dissemination,
distribution. or copying is strictly prohibited. [t'you think. you have received this document in error, please notin the sender immediately and destroy the original.

 

 

 

 

libit?l ?iblt?j  
lWednesda December 31, 2an 9:45 AM
lib; [mag-:42 U. 

 Ital! {coctcorpeaibssT}; - 
Vaccination

 
 

 

 

icocicomniosnn; (cocicoTPeniosnt)

 

 

vaccination requirement? If I remember correctly from the last
inspection, SPB was oing to have both labs in their possession during next weeks inspection. it that is the case
does the 1 yearvaccine requirement still stand?

If so we will need to reschedule part of the inspection. We can still continue with the and support space and
do the later in January or early February.

Thanks,
lions; I libjrpij: I

my: ,4

SRA international, Inc.

Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE, MS A46

Atlanta. GA 30333

[mi-Bf;  

 

 

 

 

 

This document is intended for the exclusive use of the recipientis) named above. It may contain sensitive information that
is protected, privileged. or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipientts), any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

5
Accession Number: Special91714 Page: 663 Sean Date: 2014?09?17 COPY

 

Er

. 
252a..mi.uu-.uh_ 

 

 

 

OSEP Customer Satisfaction Survev.

This document is intended for the exclusive uSe ofthe recipientis} named above. it may contain sensitive information thal is protected, privileged, or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientis), any dissemination,
distrihution. or copying is strictly prohibited. If you think you have received this document in error. please notify the Sender immediately and destroy the original.

 

(CDCICDTPERIDSAU (CTR)
IWednesda December 31, 2008 9:56 AM
lib} (?383442 (CDCJOCOOIUSEP)

- 4- (coercorperuossr); (coercorpewosm; (CDCICOTPERIDSAT)
RE: Vaccination

 

     

Thanks.

 

 

lib} llibj:i3j::42 Ul (CDCIOCDQIDSEP)

.Wednesda December 31, zone 9:54 AM

?33153 [bit-53 

- - (coercorpcrupsnr); teccrcoreewosm; {coucoTPERrDSA'ri
RE: Vaccination

      

 

     

but to the best of my knowledge and in accordance with our safet olicy.
the '1 year vaccination requirement stands due to the active status of the [Cute Scone] 

 

 

SPB had both of the labs when DSAT was here in OCUNOV but att 
Branch is hot in the West Side. Please note that we inspected theuso.
Vivarium space in nd during the OcUNov inspection.

PB is hot in theEast Side and trueggugg?
and associated 252301:-

   

 

We can do the SPB and support space only next week or save it until the are reviewed-whichever
works best for DSAT. Let me know.

Sincerely,

 
 

enters for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

i 33:42 
252m-

 

E-

 

 

 

4
Accession Number: Special91714 Page: 664 Sean Date: 2014-09?17 COPY

Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop 
Atlanta. GA 30333

 

3:42 use. 


 

 

 

1..- 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the named above. It may contain sensitive information that is protected, privileged, or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. if you are not the intended recipientts), an},r dissemination,
distribution, or copying is strictly prohibited. if you think you have received this document in error, please notify the sender immediately and destroy the original.

 

this: ?minis: IrcocrcoTPEwosAn (CTR)
IWednesda December 31, 2008 11:42 AM
In}: mine-=42 (coclocoorosem

  (cooco'rpewosm; mtia'; (CDCICOTPERIDSAT)

RE: Vaccination

 

    

 

 

 

 

 

i wanted to clarify that the 1 year vaccination requirement is in place for the only? Therefore. if we only inspect
the (alley-t2 use. a and reschedule the a 3 year vaccination will suffice?

252mm;

 

 

  

 

 

m? rb';

If so we will inspect the  forw space for 835 and support space for '26

 

 

 

 

next WEEK.

 

Thanks.

 

   

       

From: $113314? J. (cwocoorosem

Sent: lWednesda December 31f 2003 

To: sine: (cocxco'rpemoss cm

Cc:   m3; me: (cocicowewossn;tcocrcomarosm
Subject: RE: Vaccination

 

 

utoi Seep 

 

 

 

Sincerely.

 

[b {33:42   
2523ch

Centers for Disease Control and Prevention

 

 

 

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

[emf-Lei I a r?  I
252mm?

 

3 
Accession NUmber: Specia191714 Page: 665 Sean Date: 2014-09?17 COPY

 

I
Centers for Disease Control and Prevention
Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE, Mail Stop A-22
Atlanta, GA 30333


2seatmc 

 



 

 

 

Customer Satisfaction Survey.

This document is intended for the exclusive use ofthc recipient{5) named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed, or copied to persons not authorized to receive such information. It" you are not the intended recipientts]. any dissemination.
distribution, or copying is strictly prohibited. [fyou think you have received this document in error, please notify the sender immediater and destroy the original.

 

 ile3] NCZVED)

   

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   


 Wednesda December 31r 2008 1:10 PM

To: It I- cocrocooiosepi; . {coercoomczvem

Cs: 

 RE: Vaccination

The Current annual boostevaccination is required for those with potential direct laboratory exposures to 
via their presence and activities in the laboratory where the virus is manipulated - am?
Regards.


DVRDINCZVEDICCID
Centers for Disease Control and Prevention
Atlanta: GA 
anaqa
  
From: rs? "teete? (cociocoorosesl)
Sent: I. all- . It ember 31,   pH 
we, (coqcctomczveo)
 (coercctoinczveo)
act: FW: Vaccination
Please see below and let me know.
Many thanks.
rb}i3j::42
[bit -
2623th
Centers for Disease Control and Prevention
Of?ce of Security and Emergency Preparedness
2
Accession Number: Specia191714 Page: 666 Scan Date: 2014-09-17 COPY

 

Inna: I Imus? I (CDCIOPHPRIDSAT)

   
  

 

 

From: mi? . icoc:ocoo:oseei

Sent: Wednesday, December 31, 2008 1:23 PM

To: (CDCICOTPERIDSAT CTR

Cc: 
 (CDCICOTPERIDSAT)

Subject: RE: Vaccination

e-mail from yesterday.

 

i I
Soil-tiers for Disease Control and Prevention
Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop 

Atlanta. GA 30333

 

3::42lu.s.c. 
252mm  

 

 

 

OSEP Customer Satisfaction Survev.

This document is intended for the exclusive use ofthe recipientts?l named above. It may contain sensitive infunnation that is protected. privileged. or con?dential. and
it should not be dissentintitcd. distributed, or copied to persons not authorized to reteive such information. lfyoil are not the intended recipientts), any dissemination.
distribution. or copying is strictly prohibited. lfyou think you have received this document in error, please notify the sender iinmcdiate?iy and destroy the original.

 

 

 

 

 

 

From: lime? Hells?-  (cocic0TPERro5AT} (cm)

Sent: Wedne   "ember 31, 2003 1:1? PM

To: life-43 P. (cociocooiosem

Cc: mite:  ibit53 (cocicorpenrosm; (coqcorpenrosnn
Subject: RE: Vaccination

So does that - . it since we wilt not enter the and hence will have no direct contact with M1: 25 that it is okay
only with a 3 year vaccination?

 

 

 

252mm
Thanks.
. u. 
Sent: Wednesda December 31, ZDDB 1:15 PM
To: lib'i'i?i ?393533 (CDQCOTPERJDSAT) (CIR)
Subject: Fw: Vaccination

 

response below.

1
Accession Number: Specia191714 Page: 667 Sean Date: 2014-09-17 COPY

 

 

(CDEJOCOOIOSEPI

      
   

 

  

 

 

 

 

 

Sent: Thursda or 25, 2009 4:23 PM

TotT CTR

claims? [tag-to: Itbji?} {mp} [htt3ii42 US


Subject: Request for Information

 

I received this facsimile a few minutes ago regarding the report we submitted for the event that occurred in our 
laboratory on February 12, 2009:

 


FilEi?dading through the correspondence, have the following additional concerns that I would like clari?ed:

The event is ?led as an "incident report" by DSAT. Please clarify the difference between an "incident report" and
a Form 3 re report by DSAT. 
ii lvlustl as a report incidents such as the one that occurred in ourlabcratory on February 12 to 

I appreciate your assistance with these additional concerns.

Sincerely,

 

Er

}i 33442 
2 523 ith

 

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
isoo Clifton Road, NE, Mail Stop int-22 
Atlanta, GA 30333


 

 

 

 

 


OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use oFthe named above. it may contain Sensitive inl'on-notion that is protocted, privileged, or con?dential, and it should not
be digseminated, distributed, or copied to persons not authorized to receive such information. ll'you are not the intended any dissemination, distribution, or copying is
strictly prohibited. [f?you think you have received this doeumeni in error. please notify the sender immediately and destroy the original.

Accession Number: Specie191714 Page: 668 Sean Date: 2014-09-17 COPY

 

[0th of Scope]

 

 

 

1
Accession Number: Specia1917l4 Page: 669 Scan Date: 2014-09-17 COPY

 that day, was vaccinated within an hour ofthe incident. I was unable to directly
EEW?act Inger after speaking with so I roceeded to send her an Email describing the incident. I later spoke with
Inger in her office after which ,immediately called you to report the violation. In response to this
incident, corrective measures will be taken to 1] retrain the user who made the error, and 2} to add prominent signage
to the west side entrances warning that unvaccinated persons are not allowed to enter beyond the doors. I will work up
this signage and send it to you in the morning. As a last comment, I would like to say that the person who committed
the violation is one of the most dependable and conscientious users of the and predictably, is very upset over this
incident. Speaking from experience, there will be time when mistakes are made, but I have the utmost confidence in the
training and abilities of users, as well as the oversight for the operation of the facility. We will further discuss
this incident at next week 26  Operations Group meeting. Best regards.

  

 

 

 

 

 

 

[b}[3}i42 U.S.C. 252aih}

 

 

 

.. 2
Accession Number: Specia191714 Pagez-688 Scan Date: 2014-09?17 COPY

 

 

From:
Sent:
To:
Go:

Subject:

 

 

 
Thursda Oct er 2011 3:18 PM
3 33  . 

       

 

(cocroeHPRrosar);   2  

:3 3? 3?3 {bii?l .
I. -
FW: [3:242 incident

    

 

 

[003,242 [0:131:42 
2

 

 

Please see report below from 523i?? Manager, regarding report of deviation from standard access
Let me know if any additional information is required from our entity as a result of this

daf??'rrence.

Respectfully submitted.

 

 

Luann;

Centers for Disease Control and Prevention

 

Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

[bit 

 

2  

 



 [El-[33242 

 



 

approximately 9:40 am, and I witnessed a member of the ?3113-42 . grouprivision escorting a technician

 

 

 

 

This Email is to provide you details of an incident involving a violation of 

P32323425 21' 
Sent: Thursda October 2011 3:09 PM

  -. El 

Howard, William (Bill) 
Subject: incident

 




 

 



 

I 

 

2523M:

{non-CDC and on campus to install a device in nto the grey area of the west side of the [to use the
restroom). The technician, who was not vaccinated against passed through the door out of the personal
shower dirty side anteroom and entered a few feet into the large common area. There was no activity in the grey area,

[5:242 

no person had exited from thel [bl?msgegam I ?billijw-S-C? Ilabs, and the door leading to 

decon showers was not opened. I iIIdEted to 

 

that I woold communicate this incident, and after 252ml?

 

 

:Biosafety Manager ?mi? of the incident and my intent of informing
After hearing the details of the incident, was of the opinion that an exposure had not take
else, but that a violation of the access policy had. I later learned that the unvaccinated technician, who was scheduled

1 .
Accession Number: Specia191714 Page: 689 Sean Date: 2014-09-17 COPY

 U.S.C. 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A416

Atlanta. GA 30333

[bli?l

 

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

 

 

 

  .. errata-u-  
Edit: Thursday.r January 06. 2011 10:0? AM
To: first (cocropHPwosnT)

 
 
 

 

 

 

 

Cc: at?? mire


 . 



 

 

  

 

 

The purpose of this e-mail is to report a possible occ exposure to 'r 2 . as reported by our Data and Secimen

Handlin team. Our DASH specimen accessioning team received a shipment on Tuesday for processing a 
The paperwork and isolate were sent to the appropriate laboratory for culturing. it appears that

iitdividual processing the specimen in the recipient laborato rocessed the ecimen on the open bench before realizing

  

   
    

 

     

that the actual isolate provided in the shipment was not a midi: - isolate but rather a .
isolate.
In reviewing the paperwork ?r 'ng the specimen. it was noted that the aenivork for the isolate was

  

 

isolate was not present in the

 

stapled to paperwork for a team: .54 'isolate. and that the   

 

 

lbjil3jz-142 
shipment but the 25m. isolate was.

 

         

 

. isolate has been transferred to the laboratory of [more U.S.C.?252aihi for culturing. If select agent is
idei?tified in the isolate. a Form 4 will be generated. The individual involved in the initial handling of the ibirsi?zgguhscs
isolate was sent to our Occupational Health Clinic for appropriate medical follow-up. 

 

 

 

Let me know if any additional information is required at this time regarding this report.

Sincerely.

 

 

 

[33:42 
'3 Fi?-2m"

 

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop 

Atlanta. GA 30333

in: 3:442   
'DFi'PEi'i'l-i'i

 

 

 

 

2
Accession Number: Special91714 Page: 695 Scan Date: 2014-09?17 COPY

Please provide a brief summary report of the following items listed below within ?fteen (15) calendar days
following receipt of this email. The level of information being requested may be in the form of quality control
documents andior reports.

thank you in advance for your attention given to this matter to expeditiously move forward with this

 

process.

Cook tanks annual re-veri?cation maintenance records.
Printout of QC operations ofcook tanks (bldg E?s
QC data for Spore testing from cook tanks.
Air Quality data for breathing compress air.
HEPA filter and HEPA housing certification.
asc certification for 
Power transition ifailure of Ventilation System.
- Scheduled runs trend data with power shifts.
- HVAC trend data in power shifts during power transition.
3. General list of PM for Research Annual re-certification.
Q. BAS monitoring procedures?what happens when there is a problem?
10. Verify arrangement with Emory for exposure treatment.

?anF-P?Nr?

Res - ectfully,

 
 

 

 this? Division of Select Agents and Toxins
ice of Public Health Preparedness and Response

Centers for Disease Control and Prevention

1600 Clifton Rd. NE. Mailstop A-46

Atlanta, GA 30333

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

I  

This document is intended for the exciusive use of the recipientts} named above. it may contain sensitive
information that is protected, priviieged, or confidentiai, and it shouid not be disseminated, distributed, or
copied to persons not authorized to receive such information. if you are not the intended recipientis), any
dissemination, distribution, or copying is strictiy prohibited. it you think you have received this document in
error, piease notify the sender immediateiy and destroy the originai. Thank you.

2
Accession Number: Specia191714 Page: 700 Sean Date: 2014-09-17 COPY

 

 

 

 
 
     

 

 

 

From: lt?l 

Sent: Frida . November 05, 2010 12:203543.930- mi?rr?? 

Subject: RE: Request for Additional Information

Good Afternoon

Thank you for the email request for additionai i ation needed by DSAT to ensure complete review of our
laboratories and associated spaces in Buildings nd We will gather the requested additional information and
ensure provision within the 15-day response time- rams requested. 

Sincerely,

 

 

Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

in: 314205.05
252mg?.

 

 

 

 

 

 

 

    

 

 

 

I 
Sent: Frida November 05, 2010 12:34 PM
I 
. - 
[33(33142 

 

Subject: Request for Additional Information

  

 

 


genters for Disease Control and prevention
1600 Clifton Road
Atlanta. GA 30333

 

This email is in regards to the Centers renewal inspection conducted on October 12 thru 15, culminating the
week of October 18 thru 22. 2010. particularly, the Laboratory and applicable areas. As stated during the
closeout brie?ng, we were going to send you a list of the things we needed to validate, to clarify. and include as
information exchange in helping us to provide a comprehensive analysis of the facility operations.

1
Accession Number: Page: 701 Sean Date: 2014-09-17 COPY

 

 

 

Fr

3  
0&0 

 

(halite Customer Satisfaction Survey.

This document is intended for the exclusive use ot?the recipient{s) named above. It may contain sensitive information that is protected, privileged, or con?dential. and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended rccipientts}. any dissemination,
distribution. or copying is strictly prohibited. If you think you have received this document in error. please notin the sender immediateiy and destroy the original.

 

 

 

 

From: (coocorrenross'r) (era)

Sent: I?Wednesda December 31, 2003 9:46 AM

To: it]; I ijbj:i23j::42 

Cc: Isl-so Ircooco'rpewossr); (coercoTPEstsT); (coocorpenrossr)
Subject: tiaccina tion

 

 

I was wondering if you knew anymore about the vaccination requirement? If I remember correctly from the last
inspection. SPB was - oing to have both labs in the possession during next weeks inspection. If that is the case


 

does that year  vaccine requirement still stand?

If so wed to reschedule part of the inspection. We can still continue with the and support space and
[ogr?iQ?BB-: me later in January or early February.

252mm

Thanks.

 

 

  

 

 

 

SRA International, Inc.

Contractor of the CDC for the Select Agent Program
1600 Clifton Road. NE. MS A46

Fi? 

 

 

 

 

 

This docume?s intended for the exclusive use of the recipientts) named above. It may contain sensitive information that
is protected. privileged. or con?dential, and it should not be disseminated. distributed. or copied to persons not authorized
to receive such information. If you are not the intended recipientis}. any dissemination. distribution, or copying is strictly
prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

5
Accession Nomber: Specia191714 Page: 703 Sean Date: 2014-09?17 COPY

 

in} 
2 eaeths . 

 

 

 

Customer Satisfaction Survey.

This document is intended for the exclusive use oftlte recipientts) named above. It may contain sensitive information that is protected. privileged, or con?dential. 
it should not be disseminated. distributed. or copied to persons not authorized to receive such in fonnation. If you are not the intended recipientis), any 
distribution, or copying is strictly prohibited. It?you think you have received this document in error, please notify the sender immediately and destroy the original.

    

 tcoctcorpewosm (cm)

Wednesda December 31, 2008 0:55 AM

:[bji- itij:i3i::42 u. ibits}
-  tcocrcoriteaiosnn; ,tcocrcorpesioseri

RE: Vaccination

  

 

 

 

 

 

 

Thanks for your response and once you hear from we will make a decision about next weeks inspection.

 

    

 

 

 

 

    

Thanks.
{cocyocmyOSEp}
 IWednesda December 31, 2008 9:54 AM
To: libil?i 
Cc: its  Heist: tcocicoTPERrosnTJ; i 
Subject: RE: Vaccination
thirst but to the best of my know licy.
the 1 year vaccination requirement stands due to the active status of th  -- 

 

 

see had both of the labs when DSAT was here in OcUNov but at this time see is hot in the East Side and the
Branch is hot in the West Side. Please note that we inspected the Program and associated
to tint" during the Octi'Nov inspection.
Cl 
We can do the SP8 and support space only next week or save it until the are reviewed-whichever
works best for DSAT. Let me know.

        

Sincerely,

 

 

Dal

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1500 Clifton Road. NE, Maii Stop A-22

Atlanta. GA 30333

 

ih;:i 


 

 

 

. 4
Accession Number: Specia191714 Page: 704 Sean Date: 2014?09?17 COPY

Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop 
Atlanta. GA 30333

[t use. 
252aiae._a

 

 

 

 

DSEP Customer Satisfaction Survey.

This document is intended for the exclusive use ofthe recipientl's} named above. It mayI contain sensilive infonnation that is protected. privileged. or con?dential. and
it should not be di55eniinated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientts). any dissemination,
distribution. or copying is strictly.r prohibited. If you think you have this document in error. please notil?y the sender immediately and destroy the original.

 

 
 

  
 

 

limits; I (cocicoipewosm (CTR)

.wiaen - - ber31, 

I cociocooiosem

- DcfcoTPEstm'); icoqcoreeniosm  

 

RE: Vaccination

 

I wanted to clarify that the 1 year vaccination requirement is in place for the only? Therefore, if we only inspect
the SP3 and reschedule the a 3 year vaccination will suffice?

If so we will inspect the for SP8. space for SP3 and support space for and SP3 next week.
Thanks.

 

 

 

 -  ibis-317:1? I (CDCIOCOOIOSEB
.Wednesda December 31. 2003 11:19 AM

 

    

To: (cocicoTPEFuosiItT CTR
Cc: 3? ..

Subject: RE: Vaccination 

ut of Scope]

 

 

 

 

Sincerely.

 

[Eli-w it: I
252301:
Centers for Disease Control and Prevention
Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

[bi-I 33442 
assert-n

 

 

 

 

3
Accession Number: Specia191714 Page: 705 Sean Date: 2014-09?17 COPY

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop 

Atlanta. GA 30333

 


 

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use ol" the reeipienltsi named above. It may contain sensitive information that is protected, privileged. or con?dential, and
it should not be disseminated, distributed. or copied to persons not authorized to Such information. ll? you are not the intended reeipientis], any dissemination,
tlistri?olJtl'otl1 or copying is strictly.r prohibited. Il?you think you have received this document in error. please notifyr the sender in'intediotelgtr and destroy the original.

 

From: mus: 
some" Wedne' mber31, zoos 1:10 PM

  
 

cocrocoorosspt; 



RE llacei nation

 

 

 

vaccination is required for those with potential direct laboratory exposures to
?estas: presence and activities in the laboratory where the virus is manipulated

Regards,

 

test..- 

 

 

 



Centers for Disease Control and Prevention
Atlanta. GA

30333

 

 

 

 

 
     



 

 

Sent -- ember 31, 2008 12:53 PM

To: .. I mite: 
. 

  FW: Vaccination

Please see below and let me know.

 

Many thanks,

?1:133:42 

I   tomes-uses
252aih':

 

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness

2
Accession Number: Specia191714 Page: 706 Scan Date: 2014?09?17 COPY

 

 

    
   

 

Sent. ember 31 .- 2003 1:23 PM

 

To: - (cocrcorpeerosm CTR

cg; 
 .

Subject: RE: Vaccination

That would be my interpretation. Please also see Dr. Rollin?s e-mail from yesterday.

 

lb} ..


 

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[33:42 use. 


 

 

 

 

OSEP Customer Satigfaction Survey.

This document is intended for the exclusive use of the reeipientis) named above. It may contain sensitive information that is protected. privileged. or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. lfyou are not the intended recipientfs), any dissemination.
distribution, or copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original.

 

 

 

 

 

 

 

From: libii?i: I [bli?l- (CDGCOTPENDSAD (CTR)

Sent: .Wednesda December 31, 2008 1:1? PM

To: ?fT'ilbtesz 

Ce: wife: list-53 IrcoqcoTPERiosm; we (cocicorpeniosm; (coercorseniosnn
Subject: RE: Vaccination

So does that mean since we will not enter the and hence will have no direct contact with that it is okay
to inspect the SPB only with a 3 year vaccination?

 

 

Thanks,

Pram: lib; I [b36142 

Sent: Wednesda December 3Lr 2003 1:15 PM

To: (coocowewosm (cm)
Subject: Fw: Vaccination

?ease  response below.

1
Accession.NUmber: Specia191714 Page: 707 Scan Date! 2014-09?17 COPY

 

3::[33142   
Devan-n

Centers for Disease Control and Prevention

 

 

 

Select Agent Compliance, Roybal Campus

1600 Clifton Road, NE. Mail Stop A-22
Atlanta GA 1n111

r. 
.. 

 

 

 

 

5
Accession Number: Specia191714 Page: 709 Sean Date: 2014-09?17 COPY


- - - - (cocimoinczveoym lei-33:42 fillies-SC-
Im?? Ilibi??i 
Subject: RE:  Training for Team Members

     

 

       

I understand this training wiil be for only spaces for the group this: 
accurate, a total of 6 insectors will need this training. Please let me know if you are requiring this tr ining for
spaces outside of and I will update the number.

and proposed for Oct 18 will need to start after this training
is completed.

Inspectors will be able to complete this training on the morning of October

 

iijE}

 

 

 

 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta GA 30333



 

 

 

 

DSAT mission; We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public hearth in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. diatributed, or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. if you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-rnail.

 

 

-   IrcocrosELsiLstPO)
her 2010 11:02 AM

-- 
 itijzr33:4  tb;:r3;::42

Subject: Training for Inspection Team Members

ibit?i

 

 

 

  

 

 

 

 

 

 

i

OSHE. has reminded us this morning that inspection team members that will be conducting laboratory
inspections in space aiso need to complete site-speci?c training. For Building that includes watching a 35-
minute video as well as program-specific training session. Please indicate the total number of inspectors that will need to
complete the training so we can ensure availability of an adequate training location. Piease also con?rm (to all on
this correspondence) that inspectors will plan on completing this training on the morning of Monday, October 10.

Sincerely.

4
Accession Number: Specia191714 Page: 710 Scan Date: 2014-09-17 COPY

 

tor-id:

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS int-46

Ailey-ll": F315. on.qu

 

tb?ziE}

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use ofthe recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document In error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

 

. (CDCIOCOOIOSHE)

y. 
   

  

 
 
 

  

 

CDCIOPHPRIDSAT(CDCIOPHPRIDSAU
Subject: Re: Training for Inspection Team Members
I. i 
3552;?? easement lab and basement labs and only.
Thanks

 

 

 

 

Sent: Thu Gd: 0? 11:55:57 2010
Subject: RE: Training for Inspection Team Members

as to whether the space is included or if this is just for the space.

 

l'lldeferto 1 

Sincerely.

 

  

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

tj::42_u_s_c_s


 

 

 

 

 

From this: 

3
Accession Number: Specia191714 Page: 711 Sean Date: 2014-09?17 COPY

 

[bli?j 

Division of Select Agents and Toxins

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

?H-uni-a Pb anqq.

 

 

ibil?)

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use ofthe recipient named above. It may contain sensitive information that is protected. privileged, or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. if you think you have received this document in error, please notify the sender

immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

 

From: i" . . 
Sent: Thursda . Och: 2010 12:52 PM

 

 

 

 

   
 

 

 

 

 

 

 

 

cocrocoorOSI-IE)
car? l-tljicl-Sr-i?g one  one  I 
(CDCIOPHPRIDSAT)

Subject: RE: Training for Inspection Team Members

Division laboratories in the would be included in the training requirement area as well.

 

 

[bits :42 
523m:

Centers for Disease Control and Prevention
Select Agent Compiiance. Ftoybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

tog-i 3:42lu_s_c_?
252mm

 

 

 

 

 

 

 

 



 

 

Pro?t?[mt I 
Sent ?Thursda October 2010 12:32  I

 

   

 


 . 

 

 

2
Accession Number: Specia191714 Page: 712 Scan Dace: 2014-09-17 COPY

 

lime: I libjzt?l I (CDCIOPHPRIDSAT)

 

 

   

 

 

 

 

 

 

From: Eli-?33? ?"3334 .. l5! 

Sent: Tuesday, 0 her 12, 2010 6:46 AM

To: [hm-:Subject: RE: HM Training for Inspection Team Members

This is ?ne by do the inspectors need to go to attend the training? I'll defer tee to whether or not
starting at 8:00 am will present any con?icts for the inspectors. Thank you again to you and Tony for your assistance in
this training effort.

Sincerely.

 

it  
:3 Fi?srh"

 

 

 

1:

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop lit-22

Atlanta. GA 30333


252mg?

 

E-

 

 

 

 

   
    

-  [were (cocrocoorosna
Sent: Tuesda October 12, 2010 6:(CDCIOPHPRIDSAT)
Subject: RE: Training for Inspection Team Members

How does training on October 13 at 8 am work for Each video will last approximately 30-35 minutes. There will
be two videos, one for and one for

 

Just to be clear, the labs in [mm ?5'0 2523i?; will not be hot during the DSAT inspection. They are currently
down for annual maintenance thus they will not require training to enter, only program escort.

Thanks

      
 

 

[b}[3}242

 

 

 

U.S.Training for Inspection Team Members

25233.11:

   

We'll need 8 inspectors to go thru the training.

1
Accession Nomber: Specia191714 Page: 713 Sean Date: 2014?09?17 COPY

     

?1:132:42 uses
262mm

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop A-22
Atlanta, GA 30333

[t use. 


 

 

 

 

5
Accession Number: Specia191714 Page: 715 Scan Date: 2014-09-17 COPY

Sent: Thursda October 07, 2010 11:55 AM
To: [b33342 ibj:3:4  
Cc:  ties 
Irma: I  
Subject: RE: Training for Inspection Team Members

     

 

 

 

 

    

I understand this training will be for only spaces for the group 
accurate. a total of 6 insectora will need this training. Please let me know if you are requiring this training for 1
spaces outside of and I will update the number.

and proposed for Oct 18 will need to start after this training
is completed.

Inspectors will be able to complete this training on the morning of October

 

 

 

tblt??

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta. GA 30333

[bits]

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-meit.

 

 


. r1: 

   

  

- - OSHE. has reminded us this morning that inspection team members that will be conducting laboratory
inspections in space also need to complete site-specific training. For Building that includes watching a 35-
minute video as well as program-specific training session. Please indicate the total number of inspectors that will need to
complete the training so we can ensure availability of an adequate training location. Please also confirm to all on
this correspondence) that inspectors will plan on completing this training on the morning of Monday. October

Sincerely.

4
Accession Number: Specia1917l4 Page: 716 Sean Date: 2014-09-17 COPY

 

ib?zl?l

 

 

 

Division of Select Agents and Tot-tins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS Fri-46
?rlanfa as some

 

[bilat-

 

 

 

DSAT mission: We regulate the possession. use. and transter o! select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 
     

  
  

;or 2010 12:03 



 

{coorOPHPRiosm
. 

 

 


Subject: Re: Training for Inspection Team Members

MCL basement lab and basement labs and only.

Thanks

 

 

 


Sigrid?ea (cocroeHPRrosnT)

cc: states - - 
 ibii?i  
Sent: Thu Oct 07 11:56:57 2010

Subject: RE: Training for Inspection Team Members

   
 

eJ 


.J

 

 

 

 

 

 

 

 

- - 
05 use 

 

 

 

 

It? defer to . as to whether the Bldg-m.  .- space is included or if this is just for the 252 262%: Space
Sincerely.
itl: f3: 42110313.. I

 



Centers for Disease Control and Prevention

Select Agent Compliance. Roybal Campus

1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

 

[33142930 


 

 

 

 

From: [m (CDCIOPHPRIDSAT)

 

 

 

3
Accession Number: Specia191714 Page: 717 Sean Date: 2014-09?17 COPY

 

[blt?l

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS lat-46

GA ans T1
[bli?l

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

 

 

This document is intended for the Exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notin the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 



  

From: I i= 
Sent: Thursday. October 2010 12:52 PM
.  ro;r3::42 

 

   
 

I

rojzr3}:42 I CDCIOCOOIOSHE)
- .  ..

- 

  

 

 

 

 raining for Inspection Team Members

mama Division laboratories in the would be included in the training requirement area as well.

252mm

 

?3131242  -  

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Campus

1600 Clifton Road. NE. Mail Stop 
Atlanta. GA 30333

[we :42hu.s.c. 


 

 

 

 

 

 

 

 

 

From [bii'i?ii 
October 2010 12:32 PM

 

 

 

  
     


- .  

 

 

 




Subject: RE: Training for Inspection Team Members

 

  

 

The 6 inspectors are made up of the teams that will inspect space for  rhino: 
as there are no additional Pl's with registered space on the basement level of E: or  the total will be 6. 

 

[?lial

 

2
Accession Nomber: Specia191714 Page: 718 Sean Date: 2014?09?17 COPY

 

runs; I (C 

  

 

  

 

 

 

 

 

 

 

ibiia?maace - i 'r  
ber 12, 2010 6:40 AM
Te- 
(CDCIOIDINCEZID): ?111495-0- 31 .. 
M53 HPRIDSAT)
Subject: RE: Training for Inspection Team Members
This is fine by do the inspectors need to go to attend the training? I?lt defer aims to whether or not
starting at 3:00 am will present any conflicts for the inspectors. Thank you again to you and 

this training effort.

Sincerely.

 

 

 


'7 R'Tlri 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

6?

3342 use. 
 

 

 

 

 

Sent: Tuesday. Octber 12, 2010 6:14 AM I
To: 11- 1?


   

 

 




 

 

 

 

 

(CDCIOPHPRIDSAT)
Subject: RE: Training for Inspection Team Members

HOW does training on October 18 at 0 am work for Each video will last approximately 30-35 minutes. There will
be two videos, one for and one for

 

labs in will not be hot during the DSAT inspection. They are currently
dei for annual maintenance thus they will not require training to enter. only program escort.

Thanks


252mb:

Sent: Thursday, October 2010 12:53 PM
To: [hie-i2 in?? [hie-=42 ,?b?tf licocrocooi'OSHE)
  (coercioinczveo); 953542.930- (copiosasnseppoi;

 

 

 

  
 

 

 

 

(CDCIOPHRIDSAT)
Subject: RE: Training for Inspection Team Members

We'll need El inspectors to go thru the training.

1
Accession Number: Specia191714 Page: 719 Sean Date: 2014-09?17 COPY

 

- 33 . OSHE. has reminded us this morning that inspection team members that will be conducting laboratory
inspections in space also need to complete site-speci?c training' For Building that includes watching a 35-
minute video as well as program-specific training session. Please indicate the total number of inspectors that will need to
complete the training so we can ensure availability of an adequate training location. Please also con?rm [to all on
this correspondence) that inspectors will plan on completing this training on the morning of Monday, October 13.

Sincerely

 

[bl-i 
252mm

Centers for Disease Control and Prevention

 

 

 

Select Agent Compliance, Roybsl Campus

1600 Clifton Road. NE. Mail Stop A-22
Atlanta, GA 30333

 

[bit 
252eih3

 

 

 

5
Accession Number: Special91714 Page: 720 Sean Date: 2014-09?17 COPY

 



- 

 

 

 

 

 

From: I ?3315: KDCIOPHPRIDSAT)
Sent: Thursda 07, 2010 11:ller? sons  Etiiggri?-Eosoq - i: -
Iii-?53 (CDCIOPHPRIDSAT)
Subject: RE: Training for Inspection Team Members

 
 
 
   

 

 

  

 

I understand this training will be for only spaces for the group and SP3 If this is
accurate. a total of 6 insectors will need this training. Please let me know if you are requiring this training for
spaces outside of and Iwiil update the number.

Please note the walk thru of HVAC facilities for and proposed for Oct 18 will need to start after this training
is completed.

Inspectors wili be able to complete this training on the morning of October 18.

[bll?l

 

 

[Oil-5.:

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta GA 30333

 

{blip}

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. If you thinl-t you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

 

 

 

 

 

[b?fmg?gl El 
 - :bumdaLOctcber or. 2010 11:02 AM
To: ea.- 
cc:  - -


Subject: Training for Inspection Team Members

5
Accession NUmber: Specia191714 Page: 721 Scan Date: 2014?09?17 COPY

 
  

and SPB As long

- the total will be 6.

The 6 inspectors are made up of the teams that will inspect space for
as there are no additional Pl?s with registered space on the basement level of or

 

 

 

 

[b ii? 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS tit?46

Atlanta. GA 30333

Tel' 404-718-9099 

iblt?l

 

 

 

DSAT mission; We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. It you think you have received this document in error. please notify the sender
immediately and destroy the original. -

Please consider the environment before printing this e-mail.

 

 

. (CDCIDCDDIOSHE)

ober 07, 2010 12:03 


i3??

 

 

 

(cocrOPHpaiossT)
Subject: Re: Training for Inspection Team Members

basement lab and basement labs and only.


252mm 

Thanks


- afhj

 


(cocroPHpniossri

 

   

Sent: Thu Oct U7 11:56:57 2010
Subject: RE: Training for Inspection Team Members

defer to i i=   WW space is included or if this is just for the space.

 

so. 5 2s

Sincerely,

 
 

Centers for Disease Control and Prevention

Select Agent Compliance. Roybal Campus

1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

4

Accession Number: Specia191714 Page: 722 Sean Date: 2014?09?17 COPY

 

    

Tm"? 
cc: ibj:[3j::42 I

Subject: RE: Training for Inspection Team Members

lei-v.2 IrcocrocooroSHE)
(cocrotoruczveo);   

 

 

 

    

We'll need 8 inspectors to go thru the training.

lbll?l

 

ibii?}

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46
silent: no mass

 

[bjri?j

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public heatth in the United States.

This document is intended for the exclusive use ofthe recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. Ifyou are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this email.



  
 
 



-  CDCIOCOOIOSHE)
3' l? .

. 

  

 

 


Subject: RE: Training for Inspection Team Members

ibli3li?42ei.EJivision laboratories in the would be included in the training requirement area as well.
262a:

 

  

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Ca mpus
1600 Clifton Road. NE. Mail Stop 

Atlanta. GA 30333

 

ibj: 
 

 

 

 

 
      

 
. 

 

   

(socioenpnrosm
Subject: RE: Training for Inspection Team Members

3
Accession Number: Specia191714 Page: 723 Sean Date: 2014-09?17 COPY

DSAT mission; We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This dosument is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-maiL

 

. .. 
as t: Tuesda October 12, 2010 6:46 A
-     cocrocooxosns)

 
   

    

CDCIOPHPRIDSAT)
. .  

     

(cocrOPHnlosriT)
Subject: RE: Training for Inapection Team Members

This is fine by do the inspectors need to go to attend the training? l'll defer to (?3?334 as to whether or not
starting at 8:00 am will present any conflicts for the inspectors. Thank you again to you and Tony for your assistance in
this training effort. -

 

Sincerely.

 

 
 

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

[b38142 uses
. 

 

 

 

 

V?l' 

 

[b'jl3'g542 U.S.C. 252301}

 

 

 

 

     
    

 

From: (cocrocoorosns)

Sent: uesda October 12, 2010 6:14 AM

To 

Cc: 42 . 

{coctOPHRrosM
Subject: RE: Training for Inspection Team Members

How does training on October 18 at 8 am work for Each video will last approximateiy 30-35 minutes. There will
be two videos. one for and one for

Just to be clear. the '3'51 labs in  ibiri31r42USO-mm:- will not be hot during the DSAT inspection. They are currently
down for annual maintenance thus they will not require training to enter. only program escort.

  

 

 

Thanks

ibj:r.s.c.?

252mm

From:  [mi 

Sent: Thursday, October 07, 2010 12:53 PM

 

 

2
Accession Number: Specia191714 Page: 724 Sean Date: 2014?09?17 COPY

 



 

-  
ober 13. 2010 3:02 PM

 

  
  
   
 

   

 

 

 

 

 

 

 

 

To; [.65  - . I

Cc: lieg?3-- 
?133395-0- 

Subject: Re: Training for Inspection Team Members

Thank you, we appreciate it.

 

 

(CD
Sent: Wed Oct 13 20:01:05 2010
Subject: Re: Training for Inspection Team Members

That will be fine. I suspect the training will take closer to 45 minutes. Video is approx 30 and we will need a few
minutes to settle in and a few for discussion.

Please meet in building 20 room 2202. OHS conference room.

Thanks

 

lb} 33:42 see
252 n;

 

 

 

 

 
  


 fbli3jiz42 I I
(CDCJOIDINCZVED): i1= .- 

 

 

 

      


Sent: Wed Oct 13 13:09:012010
Subject: RE: Training for Inspection Team Members

has a meeting Monday morning and won't be available until We are also planning an openin
meeting with the RO's office Monday morning. Could we schedule the inspectors training for 9AM and i for
9:30?

Where we will report to for training?
Thank our



 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

some
[bli?l

Accession Number: Specia191714 Page: 725 Sean Date: 2014-09-17 COPY

 

 

1600 Clifton Road NE MS A46
Atlanta. GA 30333

 

 

 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

2
Accession Number: Specia191714 Page: Scan Date: 2014-09-17 COPY

 

 

Ilbjii?j: Ilibii?: I 

 .. El 
[m  2010 12:50 PM

     
         

      
    

 

 

To: (CDCIOPHPRIDSAT - 33 3? (CDCIOPHPRIDSAT 
ml?! (CDCIOCOOIOSHE - we:
mite: [blill?] 
 lforl [b31763 - - -
252alhj:

 

group has not yet provided a response as to an earlier availability (8:00 am) for Wednesday's inspections for
the. l'll group as soon as I receive it.



[is
Centers for Disease Control and Prevention

Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

3 33:42 uses
252s'm3m.

 



 

 

 

 

 

  
  

     
   

 

 


(CDCIOPHPRIDSAT)
ar lfor
  

 

 

ibiiEi]

 

tor Was this a request for him to inspect the shes. a
instead? 

 

 

 

 

 

 

 

 

 

If $133.. designee is available earlier on Wed AM, we will try to inspect both   

 

 

 

 
    

 

 

 

  
ed AM and avoid the schedulin conflict on Thurs AM that lead to the request to ?ills-?- to
wit  -- ., we: would like Isis? 1m?- and leis-?- Illa accompany - act
Ecsgaces.  . . H's-g; rm? vaccination but would need training.

 

 

[biilf33242 
2528M:

If this to inspect space for we currently have Team A scheduled for this
Tt?j?Es?M. Please let me know if we will be changing this.

Thanks



I Eh 

Elvisiolnnof Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

 

 

 

 

1
Accession Number: Specia191714 Page: 727 Sean Date: 2014-09-17 COPY

 

1600 Clifton Road NE MS A416
Auanta GA 30333

ions;

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors ol
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

2
Accession Nomber: Specia191714 Page: 728 Sean Date: 2014?09?17 COPY

 

Ilbilel I I?m-53 I (CDCIOPHPRIDSAT)

           

 

 

  

 

 

 

 .l 1i. --2
Sei?ti
To: - (CDCIOPHPR
Lbasal(score - 
mils ibis?   .. .,
Mali lforl lbif?i  

 

 

2  

T?g? group has not yet provided a response as to an earlier availability (8:00 am) for Wednesday's inspections for
them. I?ll provide response on availability of the ?ills? group as soon as I receive it.

 
 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE, lvlail Stop 

Atlanta. GA 30333

 

 

 

 

 

 

 

   
   

   
      
  
  
  

[b 334421.153. 

From:  me I 
Sent: Monda October 2010 12:44 PM
To: this} W4 
lea":-  1 (cocropupaioserl; Ha 

 

[ell-5M??  Ifor I rill-la: I

5525a;

 

 

lee;

   

1 -  
instead?

Was this a request for him to inspect th use. 

sin.

 

 

 

 

 



designee is available earlier on Wed AM, we will tryI to inspect both ind-"Bldg 
AM and avoid the schedulin con?ict on Thurs AM that lead to the re 
to inspect'lbil?l

 

    
    

     
   

 

    
  

       

 

 

1i 7  i'  like libil?i ?3335? and libi?i?i IEto accompany
[bah Cspaces. Bot_h__ljla_ve__ vaccination but would need training.
   

 

lithjs to inspect space for lbizl?ir we currently have Team A scheduled for this

Please let me know if we will be changing this?



I ibil?i:

 

 



 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1
Accession Number: Specia191714 Page: 729 Scan Date: 2014-09-17 COPY

cc. [hilt-12

   

-  . . . 
Subject: RE: Inventory Discrepancy-"um Material Missing

 

l:  (CDCJOPHPRIDSAT)

 

Thanks mi? 

I appreciate the updates you provided in investigating the recordkeeping issues and how they were
resolved.

Have a good weekend.

 


592m"

 

 

 

 

2
Accession Number: Specia1917l4 Page: 730 Sean Date: 2014-09-17 COPY

 

lim'?] I (CDCIOPHPRIDSAT)

    
    
  

 

 

 

 

 

From: M42 
Sent: Frida October 22, 2010 6:56 PM
To: wine-:2 In.? 
Cc: - - - i-  l?Ime: this: 
we: Flowers,
Connie (cocrommcezm); Rumph, Wallace 
Subject: RE: Inventory Material Missing

2?2aih?


 
    

 

 

 

 

We hav our investigation into the 252mm inventory discrepanc noted for the
storage location. We have determined that no vials 
Wea?lhventory. The discrepancy noted by the DSAT inspectors, ibii?? land I  I
record keeping errors in the inventory records. Please see attachments for a more detailed explanation of the events that"l 

lead to the inventory record inaccuracy.

[Eli-i
MARKEN can can - sen -Updated
confirmation of .. Invoicemnht Report. 

nspection of the

 

 

   

nted immediately concerning the management of regulated inventory in the 

[b [3:242  storage locations.
2 h2a 

 

A hard copy lab notebook will be maintained in the storage locations to record all activities in the inventory. to
include R0 reconciliation events;

a An in-person in-service training session will be scheduled with the RD's office for next week to re-train personnel
responsible for maintaining inventory in the aforementioned storage locations;

- Physical inventory reconciliation by the program will be implemented on a routine basis, such as 

Thank you in advance for your support during our entity recertification inspection process. Please feel free to contact me
if you need additional information regarding this submission.

Kindest regards.

 

 

Ceant'ers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22
Atlanta. GA 30333

.3342 use. 
2s2srn.j:.. 

 



 

 

 

 

 

 

Accession Number: Specia191714 Page: 731 Sean Date: 2014?09?17 COPY

 

. 

. -  - 
Subject: RE: Inventory Discrepancy-""No Material Missing

 

 

Thanks 
resolved.

. I appreciate the updates you provided in investigating the reoordkeeping issues and how they were

Have a good weekend.

In} 
252a?.th

 

2
Accession NUmber: Specia191714 Page: 732 Sean Date: 2014?09?17 COPY

 

libii?i I libi'?: I 

 

 

   

 

 

 



 

Connie Rumph, Wallace 

 .. .. 
sent-t Fridar October 22, 2010 6:56 PM
To: - CDCIOPHPRIDSAT)
cc: M33142 JG 0 
Subject: RE: Inventory Discrepancy?"No Material Missing
Torn,

 
 

lead to the inventory record inaccuracy.

MARKEN -
confirmation of s. ..

   

 

 

inurepam

 new?, 

"Mtge. discret:
storage location. We have determined that no vials of

ventory. The discrepancy noted by the DSAT inspectors. II: thin: larro' 

record keeping errors in the inventory records. Please see attachments for a more detailed exp

DSR - SRP 

 

?j

Invoicemht Report

 

 

. - -- --  
Bagarozzi, Dennis Jr._ {cociOIomcezno}; Flowers.



 

 

252mm

 

 

 

 

 

 

 

 -
anation of the events thai 

 

 

   use. 
 
252m;-

The following will be implemented immediately concerning the management of regulated inventory in the 

Istorage locations.

[In-of?? I If: r? c. 
2s2t?irh:

- A hard copy lab notebook will be maintained in the storage locations to record all activities in the inventory, to

include R0 reconciliation events;

responsible for maintaining inventory in the aforementioned storage locations;

An in-person in-service training session will be scheduled with the ROS of?ce for next week to re?train personnel

Physical inventory reconciliation by the program will be implemented on a routine basis. such as 

Thank you in advance for your support during our entity recerti?oation inspection process. Please feel free to contact me
if you need additional information regarding this submission.

Kindest regards.

 

 
252arh?.

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

 

 

 

m2 31:42 ?30%

 

 

 

 

 

       

From: (CDCIOPHPRIDSAT)
Sent: Frida October 22, 2010 2:ibil'3'342  .    

2525mm"

 

 

Accession Nomber: Specia191714

1
Page: 733

Sean Date:

2014-09-17 COPY

 

. 3i?: . 33-"3
Subject: RE: Inventory Discrepancy-?um Material Missing

 



Thanks I appreciate the updates you provided in investigating the reoordkeeping issues and how they were
resolved.

Have a good weekend.

 

Eb, 
252arh':

 

 

 

 

2 
Accession Number: Specia191714 Page: 734 Sean Date: 2014-09?17 COPY

 

lists} I I (CDCIOPHPRIDSAT)

 
 
 
 
 

 

 

 

 

 

 

 

 

 

   

.. I 
S?g?fi 22, 2010 6:32:9; HQ 
 -- D) 
Emory lasing
i

 

 

 

 

 
 

 

 

   
   

extrema,  discrep. I
- storage location. We have determined that no vials of   
the inventory. The discrepancy noted by the DSAT inspectors,  Ibi=?g=4? 2  mig~3233452  and  - --  
remrd kee?ing errUrS in the invent?r?y records. Please see attachments for a more detailed explanation of the events tha'W?

lead to the inventory record inaccuracy.
v. ?ih 
a a
a @311

[ET-{lit
iscrepant osn DSR-SRP DSR_Inventor?r winder-ed- 


confirmation of s. .. Invoicermht The following will be implemented immediately concerning the management of regulated inventory in the 
lstorage locations.

 

.- A hard copy lab notebook will be maintained in the storage locations to record all activities in the inventory, to
include R0 reconciliation events;

- An in-person in-service training session will be scheduled with the RO's office for next week to re-train personnel
responsible for maintaining inventory in the aforementioned storage locations;

0 Physical inventory reconciliation by the program will be implemented on a routine basis, such as 

Thank you in advance for your support during our entity recertification inspection process. Please feel free to contact me
if you need additional information regarding this submission.

Kindest regards.

 

[bloke  I
02a in:

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
160D Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

[t 31:33:42 U.S.C. 
 

 

 

 

 

 

 

 

Sent: Friday, October 22, 2010 2:3?r PM

 

       

1
Accession Number: Specia191714 Page: 735 Sean Date: 2014?09?17 COPY

 

- .  .  
Subject: RE: Inventory Material Missing

 



 

I appreciate the updates you provided in investigating the reoordkeeping issues and how they were

resolved.

Have a good weekend.

 

 

 

2
Accession Number: Specia191714 Page: 736 Sean Date: 2014-09?17 COPY

 

 
  
   
 
 

 

 

 

 -  
r22, 2010 6:56 PM


 

 

 

 

 

ibii?? I 

  

 

 

 

 

 

 

 

 

 

 

 

    
  

 
 
    
 

 

 

 

[by 5.  
 - I
Sil'Hect: RE: Inventory Material Missing
Torn,
inventory discre - - a - - - - - 'inspect-ion-uemtha;
is  storage location. We have determined th ?3:13:42 U505 
riventory. The discrepancy noted by the DSAT inspectors and I Iwas a result of 2mm?

 

 

 

record keeping errors in the inventory records. Please see attachments tor a more detailed explanation of the events that

lead to the inventory record inaccuracy.
In] 
emit

     

DSR - 5gp Dani-Mentor dated 
confirmation of s. .. .. Invoicem'uht 

252-3t'h}

 

The following will be implemented immediately concerning the management of regulated inventory in the 
 Istorage locations.

r-r La.-

2E2aih':
A hard copy lab notebook will be maintained in the storage locations to record all activities in the inventory, to
include R0 reconciliation events;
a An in-person in-service training session will be scheduled with the office for next week to re-train personnel
responsible for maintaining inventory in the aforementioned storage locations;
a: Physical inventory reconciliation by the program will be implemented on a routine basis. such as 

Thank you in advance for your support during our entity recertification inspection process. Please feel free to contact me
if you need additionai information regarding this submission.

Kindest regards,

 

   



252331;: I 
Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus
1600 Ciifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

[3342030. 
252mm.? 

 

 

 

 

 

  

- - a 
ctober 22,. 2010 2:3? PM
- 

 
 

1
Accession Nomber: Specia191714 Page: 737 Sean Date: 2014-09?17 COPY

Please

provide a brief summary report of the following items listed below within ?fteen (15) calendar days

following receipt of this email. The level of information being requested may be in the form of quality control
documents andior reports.

 

process.



B.
9.
10.

thank you in advance for your attention given to this matter to expeditioust move forward with this

Cook tanks annual re-verification maintenance records.
Printout of 00 operations of cock tanks {bldg
QC data for Spore testing from cook tanks.
Air Quality data for breathing compress air.
HEPA ?lter and HEPA housing certi?cation.
BSC certification for
Power transition failure of Ventilation System.
a Scheduled runs trend data with power shifts.
at HVAC trend data in power shifts during power transition.
General list of PM for Research Annual re-certification.
BAS monitoring procedures?what happens when there is a problem?
Verify arrangement with Emory for exposure treatment.

Res ectfully.
i

 I I i" it

 

libir?} I

mite: Division of Select Agents and Toxins

 of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, Mailstop A-46

Atlanta.

i 42 
D?dll 

GA 30333

DSAT Vision: To be the preeminent resource for the safety and security of bioiogicai agents and toxins.

This document is intended for the exciusive use of the recipient(s) named above. it may contain sensitive
information that is protected, priviieged, or con?dentiai, and it shouid not be disseminated, distributed, or
copied to persons not authorized to receive such information. if you are not the intended recipient(s), any
dissemination, distribution, or copying is striotiy prohibited. it you think you have received this document in
error, piease notify the sender immediately and destroy the originat. Thank you.

Accessi

2
on NUmber: Specia191714 Page: 738 'Scan Date: 2014-09?17

COPY

 

Iibl-i?l I rm} (CDCIOPHPRIDSAT)

 
 
 

 

 

 
  
 

 

 

 

 

 

a ?15953.? .. -  .. lcocrosasdsepeoi
 mber05.201012z38 PM
To: mil-'6': cocroel-leniosan
Cc: ibis?: [his icocroPHPRiosAT- Ii=-  
ibis:- icocroeHPRrosei');   - - ism 
Subject: RE: Request for Additional Information
Good Afternoon

Thank you for the email request for additional inf rmation needed by DSAT to ensure complete review of curreaagvse. 
13mm? 3'65 and associated Spaces in Buildings and We will gather the requested additional information and Mt?
ensure provision within the 15-day response time-frame requested.

Sincerely,

 

 

[0'33 1&2  
Centers for Disease Control and Prevention
Select Agent Compliance, Roybai Campus
1000 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

use. 


 

 

 

 

 

From: (cot/epnpalosar)

Sent: Friday, November 05, 2010 12:34 PM
To: I [bjri3?142 I 
Cc: sills 
ibisii-WS-C- ?i'iB-W 
Subject: Request for Additional Information

 

  
 

 

 

3 i - - 
. 

 

 

 

    

Responsible Of?cial

Centers for Disease Control and Prevention
1600 Clifton Road

Atlanta. GA 30333

 

This email is in regards to the Centers renewal inspection conducted on October 12 thru 15, culminating the
week of October 18 thru 22. 2010* particularly, the Laboratory and applicable areas. As stated during the
closeout briefing, we were going to send you a list of the things we needed to validate, to clarify, and include as
information exchange in helping us to provide a comprehensive analysis of the facility operations.

1
Accession Number: Page: 739 Sean Date: 2014-09-17 COPY

 

 

rm} I 

 

    
  

 

 ..   
en' 'v?londa Setember 1Q, 2011 1:43 PM
saileuscs  - a  I (CDCIOPHPRIDSAT)
3 3' 3* (CDCIOPHPRIDSAT)
Subject: RE: Inspection of suites

 

have received con?rmation from Viral Special Pathogens Branch that the second week of December will work for them.
Program by tomorrow.

252mb:

Best regards,

 
 

  

3-3342  
.E?nlf'ers for Disease Control and Prevention Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Man Stop A42

Atlanta, GA 30333

lb}. 
2 522%:  

    

EH:



 

 

 

 



  
Monday, September 12, 2011 9:52 AM

Cc 2523(hliblt?i 

 
 
 

 

 

 

 

  Suites

252?'tn}

 

 



Eaga??lm?a: would like to inspect the suites in sometime during the first two weeks of December.
laboratories are to be inspected annually. Because no travel is involved, this could be spread out over several days. Will
this time frame work for you and the Pl's?

 

 

 

 

1
Accession Number: Page: 741 Sean Date: 2014-09-17 COPY

 

  
   

We are currently working on pape gens Branch, the Program, and
We will have that paperwork submitted as
2523i?? soon as it is available and we understand the urgency to get these amendments into the program for review and
acceptance. These labs will be equipped with entirely new equipment. Movement into these facilities is also

anticipated for the end of November.

As always many thanks for your continued support.

 

 

 

 I

5e t: Fridav. Au ust 19, 2005 12:29 PM
To: Ilblt'B}
Subject: SA Lab Moves into Building
Importance: High

Per your voice-mail message request, the following is provided:

 

 

 

 

Our current move schedule into Buildin indicates that the following select agent-registered labs will be moving
their entire lab operations into Building 
[b'leI

 

 

 

 

Lab) Move scheduled; Week of September 19. 2005

 

[bli-Efr- Lab) Move scheduled: Week of November 23, 2005
Your consideration of postponing laboratory inspection for these two lab groups until their move into our new lab
building is greatly appreciated. Please con?rm with me as soon as possible that these inspections will be
delayed.

Many thanks in advance.

 

 

 

citatepassg. -  
2523??) Centers for Disease Control and Prevention
Office of Security and Emergency Preparedness
1500 Clifton Road, Mail Stop D15
Atlanta GA 30333


 

 

 

 

 

3
Accession Number: Specia191714 Page: 743 Sean Date: 2014?09?17 COPY

 

   

 

 

 

 

 .12.-.. . El 
.- g-Siesdev Octane-11.20051152 AM
To: 
Cc: Gorny. Tammy 
 
Subject: RE: SA Lab Moves into Building


In an effort to provide additional clarification. please note the 

I believe the SAP inspection team may have misunderstood the OHS inspection process in that the OHS inspection
provides final approval for the labs to go ?hot? for work with hazardous materials once they have completely moved in and
once all site-speci?c safety issues have been addressed to include updating all safety manuals. Dr. Weyant's e?mail
provided further clari?cation of the OHS process. In August we had discussed combining the SAP inspection with the
OHS inspection. however. OHS expressed a desire for this not to occur. Unfortunately. OHS was not able to have a
presence at our meeting in August. Our office did pass that message on to SAP.

n- - gh. please be aware. that we may be conducting the

laboratory. We may be looking at rooms without

speci?c signage posted or manuals updated to re?ect site-speci?c information for the Bid location. I will 
to get a jump start on the update of the manuals for the space. 

 

 

 

 

I will endeavor to get amendments into your of?ce for the suites to be registered this week. but I cannot guarantee

that these will be submitted as requested by COB on Thursday. Th mber dates that I rovided to you in my e-mail

below are based on a published schedule for occupancy of the use. 

lab. this may be a moving target. We appreciate the natiorf?i'a'ihi

program?s willin to work with us based on the various difficulties we face and may face as we work to
Building and subsequently move in.

252ain":

In the meantime. I have asked for clarification from

 
      

 

   

    
  

   
   

[bj'ri?jz

as to the status of East year?s inspection results and

 

 

 

whether any additional information wijdm It.  of information for the responses for the
sace registered and inspected unde rovided an update for the Program
{March 16. 2004] inspection but not yet for thel this:  inspection {July 2004).

 

Respectfully.

 

 

   

 Tuesday, October 11. 2005 10:35 AM

.. [bj;i13j::42_  

[big-:42Ject= RE: SA Lab Moves Into Building I

Importance: High

 

 

 

Regading OHS and the email to CAPT Weyant. our discussion during the inspection was that OHS would provide
doccmentation that the lab was accepted by them. We understood and documented in our notes inspect
prior to move-in. However. CAPT Weyant?s email said that OHS would inspect and approve before 
hot. Indeed. in the August meeting there was a dis we would co-inspect with OHS. Since we will not be
-- ntends to go hot this week per our discussion during the
inbsEectiOn. -- and me of the results of the OHS inspection.

..

 
  
 

 

1
Accession Number: Page: 744 Sean Date: 2014-09-17 COPY

twill b?9l?.f?itiew..o.f.mendment today. Someone from this office will be contacting you about an

irisf??ection. I would sugges en of the month at the latest so that your entity will be able to respond to any
deficiencies.

We must eat ress concern that. according to our documentation of the August meeting and our many discussions

since. the would not be moved into until January. You and have repeatedly discussed the amendment for the

since the winter of 2004-2005. but DSAT has received no aperwork to date concerning these If I read

your email correctly, your entity is planning a - - IE of building in approximately 6 weeks. This is
fl plans his move. Therefore. unless we receive the
amendment shortly. we will not be able to provide a thorough review. Given the safety and securit issues we observed
during our inspectionso lab. and given the nature of the agents to be moved into the IE we must
time for the inspection and the review of the amendment than we had with 
please submit your amendment for the IEI by COB Thursday if at all possible. regardless of what state it is 
in. Also. we will need to schedule an inspection in adequate time before he move for your entity to address any
deficiencies. I look forward to hearing from you on Thursday. along m" 'tiSSiOrI of the paperwork about the
earliest date the will be available for inspection. I have cc'd as he is our resident expert. and
he or someone from this of?ce will be contacting you about scheduling inspections.

  
  

 

 

 

 

 

Please be advised that I will be out of the office next week receiving training at Emory. Therefore. although I
understand that your amendment may not be fully ready. I absolutely need to have something by Thursday if at all
possible so that i can begin my work to assist you in getting this amendment approved in time for your move.

Kindest Regards.

 

 

 

 

 

Senior Research Scientist

Centers for Disease Control

Division of Select Agents and Toxins
1600 Clifton Rd NE. Mailstop E79
Atlanta GA 30333

 

 

 

 

This document is intended for the exclusive use of the recipientisi named above. it may contain sensitive information that is protected. privileged. or con?dential.
and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientfs}. any
dissemination. distribution. or copying is strictly prohibited. It you think you have received this document in error. please notify the sender immediately and destroy

  
   

 

 

 

 
 

the original.
inal Messa
From: in?? 
Sen OctobEr 11, 2005 9:55 AM
mg ?lm 
.?m_E?Ma?mwwtawm .W mm
Sub] SA Lab Moves into Bui ding

 

Importance: High

 

Please see e-mail below which was originally sent on August Our schedule 
obvioust slid due to the delayed acceptance date of the building such that we are now looking at the move 
starting today. Thank you for the approval of the amendment. We will have the room number papenivork
amendment to you by this week's end.

 

stiil projected for Nov. have already submitted the

amendment perw

  

2.
Accession Nomber: Specia191714 Page: 745 Scan Date: 2014?09?17 COPY

 

lens: I [mil-531 (CDCIOPHPRIDSAT)



  

Ell

 
 

Porter, William 

   

 

RE: Building [b38142 uses

252m}

 

 

 

 

 

Good Afternoon

ibit??i

 

 

Issue

{coercorpeelosm};


Please find attached a copy of the written report for the event reported in my e-mail dated Friday. February 13, 2009, 8:13

pm:

 

12FE309
Incident Report F. ..

Respectfully submitted.

 

 

CU?dill,

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness

Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22
Atlanta, GA 30333

 




 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the reeipientt?s} named above. It may contain sensitive information that is protected, privileged+ or confidential. and

it should not be disseminated, distributed. or copied to persons not authorized to receive such information if you are not the intended recipienlis). any diaseminitlion.
distribution, or copying is strictly prohibited. lt'you think you have received this document In error. please notify the sender immediately and destroy the original.

  

 

 

 

 

 

  

(cocxcoTPERjossn (cm)
Sent Tuesda February 2009 11:55 AM
To: lb} ?1:13:42 [coctocoorosm I
Cc: o; I tbi2t3ir42 I col CQTPERIDSAU 
 . .55UE

 

SRA ltrnational, lnc.

Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE, MS tut-46

Accession Number:

1

Special91714 Page:

746 Sean Date:

 

2014-09-17

COPY

 GA 30333


  

 

 

 

 

 

This document is intended for the exclusive use of the recipientts) named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly
prohibited If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

  
 

Cc: Porter, William Popovic, Tanja Nicholson, Janet Edwards, Jacqueline
Stevens, John R. CDC Chandler, George Bowen, Ken L. 
tEiE' . -
. .t 343%

[eociocooionsy Sandors, Martin L. (cociocootoHS)
. . . Issue
Good Afternoo

The purpose of this email is to provide report to DSAT that individuals in ..ex.per.ie.nce.ti. use. 
decon shower difficulties upon exiting the laboratory at approximately 4:05 pm on Februa 12. 2009. It is reported that2523m3
the difficulties experienced did not result in an overall compromise in containment in the laboratory or any potential
release of agent from the laboratory. Additional details will be provided upon completion of the investigation by the Office

of Health and Safety and our Buildings and Facilities Of?ce (BFO).

Respectfully submitted.

  

 

 

 

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

ib} 
-  

 

 

 

 

Customer Satisfaction Survey.

This document is intended for the exclusive use of the named above. It may contain sensitive information that is protected. privileged, or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. tfyoti are not the intended any dissemination,
distribution, or copying is strictly prohibited. lfyou think you have received this document in error. please notify the sender immediately and destroy the original.

2
Accession Number: Specia191714 Page: 747 Sean Date: 2014-09?17 COPY

DPiease consider the environment before printing this e-mail

This document is intended tor the exclusive use of the named above. It may oonlain sensitive inlonnation that is protected. privileged, or con?dential. and it should not be
disseminated. distributed. or copied to persons not authorized to receive such intonnation. It you are not the intended recipientts}. any dissemination. distnibution. or copying is strictly
prohibited. It you think you have received this document in error. please notily the sender immediately and destroy the original. Thank you,

3
Accession Number: Specia1917l4 Page: 748 Scan Date: 2014-09-17 COPY

To:l - 
Cc: I 3-
RE: [b::t3j::42



May we schedule visit for May 21st? Let me know the preferred time and what will be reviewed so I can pass
that information on to all that need to be in attendance.

cocycorpewosnr) (CTR)

Lab

  
 

 

Regards,

 

tel-31:42 I
252mb:
Centers for Disease Control and Prevention
Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

to} 3:42 use. 
 

 

 

 

Customer Satisfaction Survev.

This document is intended for the exclusive use of the named above. It may contain sensitive information that is protected, privileged. or confidential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended any dissemination,
distribution. or copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original.

 

 

 

   

 

 

 

 

From: If?? [133133342 
Sent: Tue-sea Ma assess 10:28 AM

To:  Iibin23i=r42 .(cocrocoorosEP)

Cc: ??3'3'33 (CDCICOTPERIDSAU
Subject:

Good Momth  

 

[bit??
Once construction is completed I we? would like to conduct a walk through of the .  
can close out the Form 3. His first availability is the week of May 13th or after.

 

 

 

. laboratory in order that we

 

Please advise.

  

Thanks,
Tom

Writy Specialist, Form 3 Coordinator

SRA International, Inc.

Contractor for CDC Select Agent Program, 160G Clifton Road, MS tit-46
Atlanta. GA 30333

[b313- 3342 
262th 



 

 

 

 

2
Accession Nomber: Specia191714 Page: 749 Scan Date: 2014?09?17 COPY

 

Ithi'rf?l I I libido} I 

 
 

   

 

From: --  - (CDCIOCODIOSEP)

Sent: Tuesda Ma 05, 2009 3:Subject: . Lab

Thank you, we?ll schedule for 2:00 pm on May 215t. Let's plan on meeting in the Lobby area of 

Regards.

[eta-:42 ib;;i3;::42 uses I
ll 9 I.n 9 it"

Centers for Disease Control and Prevention

 

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

[3:42 use. 
 

 

F.1-

 

 

 

OSEP Customer Satisfaction Survev.

This document is intended for the exclusive use oftlte recipientts} named above. It may contain sensitive information that is protected. privileged. or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipicnt?s}. an}r dissemination.
distribution. or copying is strictly prohibited. If you think you have received this document irt error. please notify the sender immediately and destroy the original.

 

  

From: Ilbil?? I  
Sent: lTuesda Ma 05, 2009 3:19 PM

To: l-F 3'13?? El (CDCIOCDOIDSEP)
Cc: 3'

Subject:

 

May 21 is good for me. How about sometime after lunch (2pm?) We would like to verify that the
repairs/ upgrades speci?ed in the earlier communications are in place so we can close this ?le.

thanks for your cooperation.

libjrta'; "into: I half-?Id

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

 

 

 

 

 

 

 

From: . (CDCIOCOOIOSEP)
Sent: Tuesday, May 05, 2009 3:10 PM

1
Accession Number: Specia191714 Page: 750 Sean Date: 2014-09?17 COPY

 

 

 
    
 

From:
Sent:
To:
Cc:
tenant! .    




or. 2009 12:42 PM

 

on May 21. 2009. at 2:00 p.m.--meet in Lobby area. Please
dotehthat the laboratory may actually be "hot" rtort that date based on evaluation and approval by the entity Office of
Health and Safety.

 

 

 

 

Since-rely.

 

 

42 
252athj:

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

t3;::42 use. 


 

Ei-

 

 

 

Customer Satisfaction Survey.

This document is intended for the exclusive use of the reeipientts} named above. It may contain sensnivc that is protected. privileged, or confidential. and
it should not be disseminated. distributed, or Copied to persons not :tuthorized to receive such information. It?you are not the intended recipientts), any dissemination.
distrihutiou. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 752 Sean Date: 2014-09?17 COPY

 

   

 

 

 

 

 

I?m I I
{we 
From: 
Sent: 2009 10:25 AM 
TO: - 
Subject: . ments for laps during exhaust fan failures


I believe that I mentioned this to you before and the problems it was causing. is there any way to minimize the impact of
this wording? I have received questions on this previously.

 



 

 

 

We?

01:93:42 use. 
252%;

 

-

 

 

1

Accession NUmber: Specia191714 Page: 754 Sean Date: 2014-09?17 COPY

 

3- i? OSH E. has reminded us this morning that insbection team members that will be conducting laboratory
inspections in space also need to complete site-speci?c training. For Building that includes watching a 35?
minute video as well as program-specific training session. F?lease indicate the total number of inspectors that will need to
complete the training so we can ensure availability of?in adequate training location. Please also con?rm to all on
this correspondence) that inspectors will plan on completing this training on the morning of Monday, October

Sincerely.

 

E-


25251:;th

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE, Mail Stop A-22
Atlanta rm 10111

i:3j::42lu_s_c_s
252mm  

 

 

 

 


Accession Number: Specia191714 Page: 755 Sean Date: 2014-09?17 COPY

 

F:

33420.30 

 

 

 

 

From: mus; 
Sent: - lluwua ULLUUCI 2010 11:55 AM
    

 

 

 

 
 
   

    
    

IIC: r? a one 9RD    
this? 

Subject: RE: Training for Inspection Team Members
I understand this training will be for only spaces for the group and SPB If this is

accurate. a total of insectors will need this training. Please let me know if you are requiring this training for
spaces outside of and I will update the number.

 

 

 

 

 

 

Please note the walk thru of HVAC facilities for and proposed for Oct will need to start after this training
is completed.

 

 

 

Inspectors will be able to complete this training on the morning of October

[bth-i}

 

 

ibjzis:

 

 

 

LULG I

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE l'v'lS A-46

IILI .I. ?ll 

 



 

 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such intormation. It you are not the intended recipient. any dissemination.
distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

From: 

Sent: Thursda October 2010 11:02 AM
   

i  

    
  
  

 

-

 

(oppress
Subject: Training for Inspection Team Members

 

5
Accession Number: Specia191714 Page: 756 Sean Date: 2014-09-17 COPY

 

 

The 6 inspectors are made up of the teams that will inspect non-parse ?gura? . 
as there are no additional Pt's with registered space on the basement level of or ?ill the total will be 5. 2523i??

 

 

 

 

[b?rj?l

 

 

 

 

inns:

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road NE MS A-46
as some



 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and tot-tins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use ofthe recipient named above. It may contain sensitive information that is protected. privileged, or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

From: 3342 (CDCIOCOOIOSHE)
ur .a IJ ber 07, 2010 12:(cocimoluczvso);   i ?3
(cocrOPi-ipniosnri
Subject: Re: Training for Inspection Team Members

$323522 basement lab and basement labs and only.

262mb:

   
  
 

 
        

   

 

 

 

 

Thanks

 

 

 

 

 

   

. . 

(CDCIOPHPRIDSAT)
. 1 Hat?fqm ?1383342 3?
res-?- (CDCIOPHPRIDSAT)
Sent: Thu Oct 0? 11:56:57 2010
Subject: RE: Training for Inspection Team Members

 

 

 

- as to whether the space is included or if this is just for the space.

 

I'll defer to   

Sincerely.

 

 

LULCILII.

Centers for Disease Control and Prevention

Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta.GA 30333

4
Accession Number: Specia191714 Page: 757 Scan Date: 2014-09-17 COPY

 

 

  

 

 

       

To:   this? 
Cc:  .  
(CDCIOPHP

Subject: RE: Training for Inspection Team Members

We'li need 8 inspectors to go thin the training.

 

[biIfE?

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Ftoad NE MS lit-46

 

[b?i?t

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents, hosts, and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this doCument in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-maii.

 

 

  
 
  
 

  

 

 

From: - i .  

sent: Thu ?.42 - ber 02, 2010 12:52 PM

Witt-?12 cociocooiosns)

Calm?? mitt-:42 testis-30- sin-3:42 

 

 

 

 

(cociOPHivosn'r)
Subject: RE: Training for Inspection Team MembErs

The Flu Division iaboratories in the Elldg would be included in the training requirement area as well.

 

USO. 262301]

 

 

 

Centers for Disease Control and Prevention
Select Agent Comptiance, Roybal Cam pus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333


252aTh}..- 

 

 

 

 

 

From:cocionnpniosn'r)
Sent: Thursda October 07, 2010 12:32 PM) I

  
 

 
 

 

 

To: we 4 lit??-12 -. 
cc: [33i3iz42 "z 
(CDCIOPHPRIDSAT)

Subject: RE: Training for Inspection Team Members

3
Accession Number: Specia191714 Page: 758 Sean Date: 2014-09-17 COPY

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or cepying is strictly prohibited. if you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-rnail.

From: me 
Sent: Tuesda October 12, 2010 6:46 AM

 
  

 
 
  
 

    
 

 

him? 
Cc; 1  - 


Subject: RE: Training for Inspection Team Members

This is fine by do the inspectors need to go to attend the training? I'll defer to as to whether or not
starting at 8:00 am will present any conflicts for the inspectors. Thank you again to you and Tony for your assistance in
this training effort.

Sincerely,

 

it j: 42   --

sac-er

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta, GA 30333

 

[b}[3}142 U.S.C. 2528ih)

 

 

 

 

From: $31333? - - - (CDCIOCOOIOSHE)
Sent: Tuesda October 12, 2010 6:14 AM

To: 
cc: 'i3bj:r.33:42 13.32
(CDCIOPHPRIDSAT)
Subject: RE: Training for Inspection Team Members

 
  
    

   
   

 

 

How does training on Octoer at 8 am work for Each video will last approximately 30-35 minutes. There will
be two videos. one for and one for

 


307, 2010 12:53 PM

 

 

 

2
Accession Number: Special91714 Page: 759 Sean Date: 2014-09?17 COPY

 

libii?] I Imus: I 

 

 

 
  
  

 

 

 

 

 

 

 

 

 

From: tbs-?2 WW 2 

Sent: Wednesca coloer?lsr 2010 8:02 PM

To: sti?e, gmicocirocooiroshei; .. CDCIOPHPRIDSAT)

Cc: lessen - 
sis": theirs-SC- -i 

Subject: Re: ?m raining for Inspection Team Members

Thank you, we appreciate it.

In- In- nun-uncur-

Sent using BlackBerry

 

  
  

   

Fm- . (CDCIOCOOIOSHESent: Oct 13 20:01:06 2010
Subject: Re: Training for Inspection Team Members

That will be fine. I suspect the training will take closer to 45 minutes. Video is approx 30 and we will need a few
minutes to settle in and a few for discussion.

Please meet in building 20 room 2202. OHS conference room

Thanks

El

 

    
      
 

 

 

 

 

 

     

From: 

To: ibj:i3j::42 [him-i2

cc: ibj:i3j::42 [b28142 3:


Sent: Wed Oct 13 131091012010
Subject: RE: Training for Inspection Team Members

Dr. has a meeting Mondayi morning and won't be available until We are also planning an opening
meeting with the RO's offioe Monday morning. Could we schedule the inspectors training for 9AM and BSL4 for
9:30?

Where we will report to for training?

ou.

[bii?l

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Ailnnb-t FA arm's:

 

 

[bili?l

 

 

 

Accession Number: Specia191714 Page: 760 Sean Date: 2014-09-17 COPY

Please provide a brief summary report of the following items listed below within ?fteen {15) calendar days
following receipt of this email. The level of information being requested may be in the form of quality control
documents andtor reports.

 

- -- - thank you in advance for your attention given to this matter to expeditiously move forward with this
process.

 

Cook tanks annual re-verification maintenanrewrtecords.
Printout of DC operations of cock tanks (bldg 0* 8. 
QC data for Spore testing from cook tanks.
Air Quality data for breathing compress air.
HEPA filter and HEPA housing certification.
BSC certification for
Power transition i failure of Ventilation System.
- Scheduled runs trend data with power shifts.
- HVAC trend data in power shifts during power transition.
8. General list of PM for Research Annual re-certification.
9. BAS monitoring procedures?what happens when there is a problem?
10. Verify arrangement with Emory for exposure treatment.

 

 

 

 

$93.5??ow

Resectfully,

litill?

    

 

tats  

 

 

 

as; I Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response

Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A-46
[Atlanta GA smas

 

USE. 252mm I

DSA Vision: To be the preeminent resource for the safety and security of bioiogicai agents and toxins.

This document is intended for the exciusiva use of the recipient(s} named above. it may contain sensitive
information that is protected, priviieged, or confidentiai, and it shouid not be disseminated, distributed, or
copied to persons not authorized to receive such information. if you are not the intended recipientfs), any
dissemination, distribution, or copying is strictiy prohibited. if you think you have received this document in
error, piease notify the sender immediately and destroy the originai. Thank you.

2
Accession Number: Specia191714 Page: 761 Sean Date: 2014-09?17 COPY

 

 (CDCIOPHPRIDSAT)

 

   

   
 
 

  
   

   

 

 

 

From: ibis-?i2 

Sent: lFrida November 05, 2010 12:33 PM

To: flit-Subject: RE: Request for Additional Information

Good Afternoon 

 

Thank you for the email request for additional information needed by DSAT to ensure complete review of our
laboratories and associated spaces in Buildings and We will gather the requested additional information and
ensure provision within the 15-day response time- rame requested.

Sincerely,

 262a

ll 1: 9 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop ?it-22

Atlanta, GA 30333

 

 

[0:133:42 U.S.C. 252801}

 

 

 

 

 

 

'33'3 I?m? 

Sent: Friday, November 05, 2010 12:34 PM
Twists?? 
Cc: [his i= 
ibjzi3iz42 
Subject: Request for Additional Information

  
 

 

 

 

- . 3i 




 

 

 

 

 

 

   
 

 

isease ontrol and Prevention
1600 Clifton Road
Atlanta, GA 30333

 

This email is in regards to the Centers renewal inspection conducted on October 12 thru 15, culminating the
week of October 18 thru 22. 2010, particularly, the Laboratory and applicable areas. As stated during the
closeout brie?ng, we were going to send you a list of the things we needed to validate, to clarify, and include as
information exchange in helping us to provide a comprehensive analysis of the facility operations.

1
Accession Number: Specia191714 Page: 762 Sean Date: 2014-09-17 COPY

 

  (CDCIOPHPRIDSAT)

     
 
 

 

 

   

 

From:

Sent

To: I

CC: ?new -- . --. -  ob
Stephen H.  - . 3-: . . tb::3:4 

Howard. William {Bill} 

Subject: Ejb Renovations May 25r 200T)

 

 

 
 
 

This is to confirm for ye 
renovation project for th: 
Facility Office.

cords that airflow testing and balance for the HVAC modifications and door installation
Laboratory was completed on Thursday. May 14. 2009. as per Steve Koob. Buildings and

Respectfully submitted.

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1500 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

use. 252ath;

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use ol?the recipient{s) named above. It may contain sensitive information that is protected. 0f and
it should not be disseminated. distributed, or copied to persons not authorized to receive such information. lt?you are not the intended recipientts}. any dissemination.
distribution, or copying is strictly prohibited. If you think you have received this document in error. please noti?,r the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 764 Sean Date: 2014-09-17 COPY

 

(CDCIOPHPRIDSAT)

 

  

 
  

 

 

 

 

    

 

 

 

 

From: [mm 

Sent: Tuesda May 20. 2008 4:45 PM

To: this: (cocicoTPERiosxTi;
?53 
it i: I

Cc: Popovic. Tania Edwards. Jacqueline Porter. William
Chosewood. L. Casey (CDCIOCOOIOHS Zambuto Laura R.
Katz. Jackie M. 3- ii - 3i 
(CDCIIQCOOIDSEP) 05.0. 252mb}

Subject: Potential Occupational Exposure to

Importance: High

 

i received a telephone call at approximately 4:25 pm this afternoon from Laura Zambuto. Safety Specialist, ?33?
Division. reporting a potential occupational exposure to I Ib::i3::42u.s.c.s2e2am: lvirus to an individual in the this:
Division who was processing what was thought to be seasonal ?u diagnostic specimens from Bangladesh Zambuto communicated that once it was determined that at least one of the samples was positive for
?13334 . virus. the material was moved into the registered laboratory space. and the individual
was instructed to report to our Occupational Health Clinic. 1 am in the processing of gathering more information regarding
this potential exposure and will submit a Form 3.

I left voice-mail messages with is:  and Dr. regarding this matter at approximately
4:28 pm and 4:30 pm. I have copied I'vts. Zambuto and Dr. Katz on this e-mail if any correction is necessary to information
I am reporting in this correspondences.

[bit3j::- 2 USC. 
2523? [3:333:42 
use 52 

Centers for Disease Control and Prevention

 

    

  
  

  

 

 

 

 

 

Of?ce of Security and Emergency Preparedness
Personnet Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

tbj:i3::42 03.0. 252aihj:

 

 



DSEP Customer Satisfaction Survey.

This document is intended for the exclusive use ofthe recipientts] named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such infomtation. It? you are not the intended reeipientis), any dissemination.
distribution. or copying is strictly prohibited. [t'you think you have received this document in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 766 Sean Date: 2014-09-17 COPY

 The event is filed as an "incident report" by DSAT. Please clarify the difference between an "incident report" and
a Form 3 requiring report by DSAT.
Must I as an report incidents such as the one that occurred in our laboratory on February 12 to 

appreciate your assistance with these additional concerns.

Sincerely,

 

[b'jt'33242 U.S.C. 2E2ath}

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop Fit-22

Atlanta. GA 30333

 

U.S.C. 2?26lfh}

 

 

 

OSEP Customer Satisfaction SUWEV.

This document is intended for the exclusive use ol'the recipientts] named above It may.- eoniain sensnive information that is protected. privileged. or con?dential. and it should not
he distributed, or copied to persons not authorized in receive such information If you are not the intended recipientts}. tiny diatribution, or copying is
strictly prohibited. lf you think you have received this document in error, please notify the sender immediater and destroy the original

3

Accession Number: Specia191714 Page: 768 Sean Date: 2014?09?17 COPY

 
 
  
 

(CDCICOTPERIDSAT)

 

 

To.  (sociocooroserr)
Cc:  --  (coercowearosanrcra);   -- -- - . pg
(cocxocoorossp); eel-=42  (CTR) 

Sent: Thu Feb 26 1?:23:42 2009
Subject: RE: Request for Information

Maybe I can help. When an incident like this occurs in a select agent lab, especially a lab, we need to
determine whether there was an occupational exposure or an environmental release. We have a number of criteria that we
use to determine whether this type of event requires a Form 3 report. In order to do this, we need to get the details of the
event and ask some questions.

Since our assessment of the information concluded that there wasn't either an occupational exposure or an environmental
release, we don?t record the report you sent us as a TLR. Instead we ?le your report as an incident report. Since, we are
required to report the number and circumstances of form 3 reports annually to Congress, we try to ensure that our
assessments are consistent, accurate and meet the requirements of the regulations.

With regard to whether you must report all such incidents such as the one that occurred on Feb 12 to DSAT, the
regulations require all TLRs to be reported to us within a speci?ed time frame. The consequence of reporting an event to
us in a timer manner that is later determined to not meet the criteria ofa TLR, is that we simply record it as an incident
report.

0n the other hand, not reporting an event to us on time that later turns out to be a TLR, is a violation of the regulation.

We encourage entities to contact us and discuss any event that mayr require reporting in order to ensure compliance with
the regulation.

I hope this information is useful

 

lnzbia?l "was: I 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta. Georgia 30333

 

 



 

 

 

 

 

From:  th: "wmrcocrocoorosepi
Sent: Thursda .. rv 25, 20139 4:23 PM

    
   

To: CTR . .
Cc: (coqco?rpsarosm :2 3'1
{encrocoorosem

Subject: Request for Information

 

I received this facsimile a few minutes ago regarding the report we submitted for the event that occurred in our 
laboratory on February 12, 2009:

 
 

ce, I have the following additional concerns that I would like clarified:

2
Accession Number: Specia191714 Page: 769 Sean Date: 2014-09?17 COPY

 

 

   

From: 3- 3* ?33314 
Sent: . February 26, 2009 6:44 PM
To: - -- - 
Subject: Re: Request for Information

Thank you, My personal philosophy has always been to seek the guidance of DSAT especially with high profile
situations that may not meet standard TLR criteria. Thank you. again, Regards, '13-?33?

 

 

Subject: RE: Request for Information
I think that this is a judgment call. Ifyou have events that occur in high pro?le labs such as ?u or other such
facilities, it may be useful to let us knowjust in case there is an unforeseen outcome.

Although we certainly respect the opinions andjudgment of the OHS and other CDC professionals in conducting risk
assessments and conducting incident investigations, having an external assessment performed by DSAT may alleviate the
appearance ofa con?ict of interest that some may say exists when an internal investigation is performed.

I know that some may also see an appearance ofa con?ict of interest with our assessments as well since we are also a CDC
organisation. But as you know quite well, we don't show CDC any favoritism when we inspect your facilities. Our speci?c
instructions have always been to hold you to the highest standards. Sometimes this causes friction but we have to do it.

So the bottom line, I guess, is that if you don't report an event in a timely manner that meets the criteria of a TLR, a
violation of the regulation has occurred. As I said before, we are available to discuss any events in order to help you
comply with the SA regs. 

 

libli?j I libii?l I ll-g-Hg} I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta. Georgia 3o333

 

 

[?3153

 

 

 

 

    
  

- - (coo/ocoorossp)
da February 26, 2009 5:40 PM
-  - (cocrcorpearosar)
Subject: Re: Request for Information

lt is?-thank you. I appreciate it. Our internal investigation did not deem this event to be a TLR. should I thus
interpret your response to mean that our internal investigationlrisk assessment is not sufficient to make such
determinations and we must then consult with DSAT on all such events?



Sent using BlackBerry

 

1
Accession Number: Specia191714 Page: 770 Sean Date: 2014-09-17 COPY

 

libli?i I Ilbi'i?i? I (C DCIOPHPRIDSAT)

   

   
 

 

 

 

 

 

 

 

 

From: 33 ?4 ?31334 

Sent: May . 2008 4:45 PM

To: - - 
[bit-5i (CDCICOTPERIDSAT) 
ib':iE':

Ce: Popovic, Tanja 

(CDCICCIDINCIRD): Katz. Jackie M. ?ii 
(CDCIOCOOIOSEP)

Subject: Potential Occupational Exposure to ?bi'G-ii? ?'30 5? 2523'?  Virus

Importance: High

 

I received a telephone call at approximately 4:25 pm this afternoon from Laura Zambutc. Safety Specialist, ?33334
Division. reporting a potential occupational exposure to . Ivirus to an individual in the
Division who was processing what was thought to be seasona Iagnostic specimens from Bangladesh in a

laboratory. Ms. Zambutc communicated that once it was determined that at least one of the samples was positive for
?138342 Ill?? lvirus. the material was moved into the registered laboratory space. and the individual
was instructed to report to our Occupational Health Clinic. I am in the processing of gathering more information regarding
this potential exposure and will submit a Form 3.

will": . . . -
I left voice-mail messages with and Dr. regarding this matter at approximately
4:23 pm and 4:30 pm. I have copied Ms. Zambuto and Dr. Katz on this e-mail if any correction is necessary to information
I am reporting in this correspondences.

 

 

[b::[3:2242 USE. ZEEaih'.?

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop Flt-22

Atlanta. GA 30333

 

USE. 262mm

 

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use ot?thc reeipientfs} named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such inlonttation. ll' you are not the intended any dissemination,
distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

1
Accession Number: Specia191714 Page: 772 Scan Date: 2014-09?17 COPY

 

Please visit OSEP Customer Satisfaction Survey and tell us about your recent experiences with OSEP.

This document is intended for the exclusive use ot?the named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive syich inl?onnation. It? you are not the intended recipientts}, any di55eminalion,
distribution. or copying is strictly prohibited. If you think you have received this documorrl in error. please notify the sender immediately and destroy the original.

 
  
 

 

 

 

From: (CDGCOTPEWDSAT) (CTR)

Sent: 'Wednesda ember 19, 200? 11:02 AM

To: .rbi'r (cocroeoorosem

Cc: elite tcocrcorrerzrosm); (coercoreearosm (era)
Subject:

 

Good Morning

 

have reviewed your incident report relating to the exposure tol limi??SC-52523? I Please submit a Form 3 for this
incident at your earliest convenience. Thanks,

 

 

[b33142 U.S.C. 2523M:  3

 

 

 

Contractor for the CDC
Select Agent Program

1600 Clifton Road. MS lit-46
Atlanta. GA 30333

 

U.S.C. 252ath)

 

 

 

This document is intended for the exclusive use of the recipientis} named above. It may contain sensitive information that is protected.
privileged, or con?dential. and it should not be disseminated, distributedI or copied to persons not authorized to receive such
information. It you are not the intended recipientis), any dissemination. distribution. or copying is strictly prohibited. if you think you
have received this document in error, please notify the sender immediater and destroy the original. Thank you.

3
Accession Number: Specia191714 Page: 784 Sean Date: 2014?09?17 COPY


or Release of Select Agents and Toxins." must be sent to Select Agent Program within 7? calendar days after the
discovery of theft. loss. or release of select agents or toxins.-

In addition. clinical or diagnostic laboratories and other ?htities that possess. use or transfer a select agent or toxin
contained in a specimen presented for diagnosis, verificaliclh. or proficiency testing must report upon discovery of a theft.
loss. or release of select agent or toxin.

You were correct in submitting a Form 4; however. a Form 3 is also required.

Your support in this matter is appreciated.

 

law2 I. . I

 

U.S.C. 2523th}

 

 

 

Contractor for the CDC
Select Agent Program

l??tJ Clifton Road. MS A46
Atlanta, GA 30333

 

[b36342 U.S.C. 252mb]

 

 

 

I I 

This document is intended for the exclusive use of the recipiends) hamed above. It may contain sensitive information that is protected,
privileged. or con?dential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such
information. If you are not the intended recipienl{s). any dissemination. distribution. or copying is strictly prohibited. If you think you
have received this document in error, please notify the sender imrt'lediately and destroy the original. Thank you.

 

    

 

 

 

 

   

 

From: ?this?4 1U (copiocoorossp)

Sent: Wednesda December 19. 200? 11:12 AM

To: cocrcoTPEwosAT) (one 

Cc: i ii 3- I ?3?53 ,mm - 3 1 $333142 

  3-1 I 3' 3- Edwards. Jacqueline Porter. William

(CDCJOCOOIOSEPIH Weyant. Rob 

Subject: RE: Form 3

Good Morning

Since this occurred in a diagnostic laboratory that is exempt from select agent registration requirements. some of the
fields cannot be completed. Please advise on how best to the form. I can attach the report submitted to a
partially blank form and say "see attached report." if that is the guidance provided.

Many thanks for your assistance in defining requirements fdl? completing the Form 3 for laboratories that do not appear to
fall under the purview of the regulations. 

 

[b3[33142 U.S.C. 252301]

 

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance at
1600 Clifton Road. NE. Mail Stop A-22 
Atlanta. GA 30333



 

[b38142 USC. 262aihj

 

 

 

2
Accession Number: Specia1917l4 Page: 785 Scan Date: 2014-09-17 COPY

 

(CDCIOPHPRIDSAT)

 

 

  

 

 

    

 

 

 

 

 

 

I
From: . {cosiocoorosem
Sent: ecember 19. 2007 2:15 PM
To: (CTR)
cc: ?3935? ?m5? CDCICOTPERIDSAT): ?3?57- 
CTR - . . 
Edwards, Jacqueline Porter, William
Weyant. Rob 
Subject: RE: Form 3 
Tom,

Thank you for the guidance. I am working on it now.

 

U.S.C. 

 

 

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

[1138:1242 U.S.C. 252aih]

 

 

 

Please visit gage Satisfaction Survey and tell us about your recent experiences with OSEP.

This document is intended for the exclusive use ofthe recipientis) named above. It may contain sensitive information that is protected, privileged, or con?dential, and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientts}, any dissemination,
distribution, or copying is strictly prohibited. If you think you have received this doeumopt in error, please notify the sender immediately and destroy the original.

 

     

    

 

 

From:

Sent:

To:

Cc: - mi? (bier-:42 {cocrocooiossp};
-   (cocicorpenrosm; Edwards, Jacqueline (sociocooiossp); Porter, William
Weyant, Rob 

subject: RE: Farm 3

 

Good Afternoon ?133%

Please complete as much of the Form 3 as possible. For block state "see attachment". The incident report already
contains documentation regarding the incident. For accessioning purposes include the attachment with the Form 3. Sign,
date and fax to me at 404-?18-2096.

Form 3 reporting requirements and the select agent regulations do apply in this case. The following language appears in
the instructions for the Form 3:

An entity is required by regulation to notify the Select Agent Program immediately upon discovery of a theft (unauthorized
removal of select agent or toxin), loss (failure to account for select agent or toxin), or release (occupational exposure or
release of an agent or toxin outside of the primary barriers of the biocontainrnent area} of a select agent and toxin (see 7?
CFR 331.19, 9 CFR 121.19, and 42 CFR 73.19). After the initial rationing, the APHISICDC Form 3, ?Report of Theft, Loss,

1 
Accession Nomber: Specia191714 Page: 786 Sean Date: 2014?09?17 COPY

anal-ii?; res 1mm if

 

injiisjzis use. 2523.113.

i

 

 

 

 

.- 
This document is intended for the exclusive use of the named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not belilisseminated. distributed, or copied to persons not authorized
to receive such information. If you are not the intended reclbientls), any dissemination, distribution. or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you. -

 

 

   
   

   
   

 

 

From: 
Sent: Frida Februa 13, 2039 6:13 PM
T0: was: (coercorpenrosm') {cm} 
Cc: opovic, Tanja Nicholson, Janet 
Chandler, - - - I. I Bowen, Ken L. 
'i-ZU-i - . cociccm nezvso); i: i: {morocooroi-is); . (encrocoomi-isi
Subject: Building B909 Issue

GDCICI Afternoon

 

The purpose of this e-maii is to provide report to DSAT that-[individuals in the experienced airflow and
decon shower difficulties upon exiting the laboratory at 4:05 pm on Februa 12, 2009. It is reported that
the difficulties experienced did not result in an overall comp mise in containment in the laboratory or any potential
release of agent from the laboratory. Additional details will "e provided upon completion of the investigation by the Office
of Health and Safety (OHS) and our Buildings and Facilities Office 

Respectfully submitted.

 

I U.S.C. 252mm I



 

Centers for Disease Control and Prevention 
Office of Security and Emergency Preparedness ll; 
Personnel Suitability and Select Agent Compliance Br I
1600 Clifton Road. NE. Mail Stop A-22

Atlanta, GA 30333

 

?1:13:42 USC. 2623M:

 

 

 

OSEP Customer Satisfaction Survey. . 


a;

This document is intended for the exclusive use of the reeipientisi named above. il may contain sensitive information that is protected, privileged. or and
it should not be disseminated, distributed, or copied to persons not authorized to receive such information. ifyou are not the intended reeipientls), any dissemination,
distribution, or copying is strictly prohibited. it" you think you have received this bitumth in error, please notify the sender immediately and destroy-r the original.

. 2
Accession Number: Specia191714 Page: 787 Scan Date: 2014?09?17 COPY

 

 

(CDCIOPHPRIDSAT)

libit?j: I 2 
?l

 

 

 

 

From: 

Sent: ,?ednes?av?bruary 2009 1:32 PM

To: one: (CTR

Cc: mien-its  {cocrcorpenrosnrt
Porter. William Jacqueline 

Subject: RE: Building Igsue

 

 

 

Good Afternoon [use

 

Please ?nd attached a copy of the written report for the event reported in my e-mail dated Friday. February 13, 2009. 6:13



Incident Report 

Respectfully submitted,

 

U.S.C. 262ath}

 

 

 

Centers for Disease Control and Prevention

Cities of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

U30. 2623ih}

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the recipientts] named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated, distributed. or copied in persons not authorized to receive such information. Il?you are not the intended reoipientt?s}. any dissemination,
distribution. or copying is strictly prohibited. If you thittl?: you have received this document in error. pICtL?tc notify the sender immediately and destroy the original.

 

 

Tuesda February 2009 11:55 AM

it]: rbj:i:3j::42 U. (cmyocgoygng}

 

 

 

 

 

   
 

tees minis? it?? (cooleoTPERrosm
RE: Building Issue

 

Thank you for reporting this incident. We will look for additional details to follovv once your investigations are complete.

 

[bh??j

 

SRA International, Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE, leS fit-46
1
Accession Nomber: Specia191714 Page: 788 Scan Date: 2014?09?17 COPY

?at-I'M. ?5

I. l. din-u.

DEPARTMENT OF HEALTH 8. HUMAN Public Heatth Service

 

 

 

 

 

 

Centers for Disease Control
and Prevention (CDC)
[0:133:42 USE. 252301]
T0:
Division of Select Agents and Toxins
Centers fer Disease Control and Preventiqp
1600 Clifton Road NE, Mail Stop A46
Atlanta, GA 30333
FROM:   ii 
Director, Division of Laboratory Policy arid Practice
DATE: April 20, 2012 
SUBJECT: incidents During Visitor Tours ofthe Building 3 
The purpose of this correspondence is to provide informqtion as requested in AT lette" of A ril

 

 

 

 

.I 
i ontr land Prevenqpn-Roybal Campus, fit-4.? ?Bile-43

 

[b38342 U.S.C. 262301:

 

 

As way ot background I would like to descr be important actions taken related to this event.



Accession

 

On February I6, 2012 glib of sent an email to OSHE and ARE expressing
concerns about the event in question. This email did not include anyone from the SA
Compliance Of?ce. OSHE investigated the circtq'nstances and determined that there had been no
potential occupational exposure. 

As a result ofthis determination there was no of?cial notification sent to DSAT.

As a result of the email sent on April 9, 2012, additional reviews of this incident were conducted
and summary documents of the ?ndings were d. I shared these documents with Dr.
Robbin Weyant on April 12, 2012, and he indicated that DSAT would be opening an
investigation. 

On April 13, 2012 we received the email from were use. i 252mm
by April 20, 2012.

On April 17,  nt {in email to the Form 3 email address requesting
additional information related to the event as DSAT staff was present at the time of the incident.
As ofFriday April 20, 2012, we have not heard bask. If this incident is determined by DSAT to
be reportable, we respectfully submit we will need this information before we can proceed
further in our investigation.

questing the attached response

 

 

Larsen um .4

   

a. A..-

Number: Specia191714 Page: 789 Scan Date: 2014-09?17 COPY

 



If you require anything further from us please do not hesitate to contact me or Iii-Hal I [[3354

Respectfully submitted,

LIHII 

   

- Director

Division of Laboratory Poiicy and Practice

Laboratory Science Policy and Practice Program Of?ce

Of?ce of Surveillance, Epidemiology and Laboratory Seryices
Centers for Disease Control and Prevention

1600 Clifton Road, NE, Mail Stop 

Atlanta, GA 30333

Telephone: 404498~6405; FAX: 404-498-6409

E-mail: 

HIV. TIZHOI


Accession Number: Specia191714 Page: 790 Scan Date: 2014-09-17 COPY

The following information is provided in response to your request of April 13, 2012, RE: Incidents During
Visitor Tours of the Building Vivarium 

1] Please find attached a Form 3 along with an executive summary (narrative) of events including a
timeline of what occurred. It should be noted that a risk assessment conducted by the entity
Office of Safety, Health and Environment, the Manager and the Program registered for use
of Room -3 3 did not indicate that a Form 3 [eportable event occurred during the tours
based on the fact that Room (?i334 had been decontaminated for annual facility maintenance
activities and no work with virus occurred in the room between the room decontamination and
the tour dates of February 14 and February 16, 1012. In accordance with the attached DSAT
and HVAC verification guidance [fourth attachment below), a transient excursion
does not necessarily mean that a reversal of overall airflow for the containment block has
occurred. It should also be noted that the prairie dogs that were housed in Room at the
time of the air puff incident on February 16, 2012, were naive prairie dogs that were transferred
into the room in January 2012 from Lawrenceville (where ARB maintains naive animals) as per

 

 

 

the attached log record.

   

Airflow Issue and ABSLS
Fhl-lsirrative Verification GU. ..

 

Naive Animal
Log-04202012.pdf

2} ARB has provided information that the following locations were entered by the first group of
visitors on February 14, 2012. I

 

Response: A floor plan of the vivarium is attachqd. I recommend contacting i .
to complete details on route taken on February 14, 2012 tour. The information provided below
related to room entry was obtained by ARB staff after reviewing the Personnel Log in Sheet for
the Building Vivarium:

- Information documented on the Personnel Log Sheet indicated escorted visitors entered
This room was unassigned, did not have animals present and was not hot on
February 14, 2012.

 

'lifl 

WEum_by rium_l_og
out_usage_APR2012 

Accession Number: Specia191714 Page: 791 Sean Date: 2014-09?17 COPY

3} ARB has provided the following informatidi?i regarding work activities being performed in each of
the vivarium rooms on February 14, 2012 hd February 16, 2012. The registered locations in the
Building Vivarium are highlighted in yellow below.

i Response: The following work were performed in the Building Varium on
February 14, 2012 and - . ary 16, 2diz:


   

- Naive animals maintai?ljed in tubs.
0 Room 

?33133342 U-S-C- 5* Iahimals maintained in tubs.
0 Room lu'ns??'iqu I (Unassigned)

I The room was empty. 'i'he room was not hot.

 

 

 

- The room as empty. ?i?he suite was not hot.

 

 

 

4) ARB has provided that requirements to enibr into the Building 3 3? Vivarium containment

block are as follows.

Response: Entry requirements are dependiant on the location of the study within the vivarium.
The following information is provided:

  

in Rooms and - ?TyveIi-suit, PAPR with head cover bonnet, 2 pairs of gloves,
inner shoe covers, outer shoe covers, facility shoes
- Roomsi I When thd?imites are hot, vaccination required for
entry, Tyvek suit, PAPR with head cov?. bonnet, outer shoe cover, inner shoe cover, 2 pairs
of gloves, second outer smock when handling animals, facility shoes
(TB) Tyvek suit, PAPR with hea cover bonnet, inner shoe covers, outer shoe covers,
facility shoes -
a Note: Rooms do ndi currently contain animals. Specific entry
requirements will be protocol driven
- Clean corridor No PPE is required in this area

5} The procedure for preventing entry of individuals into areas where vaccination is
required as provided by ARB is as follows.

Accession Number: Specia191714 Page: 792 Sean Date: 2014-09-17 COPY

 

 

[0:13:42 U.S.C. 252aih:

 

 

c. Training

6) ARB has provided that the last time active work with infectious agents was performed in



Accession Number:

 

procedure room [bi-3:342 prior to the tour by the second group as follows.

Response: The last active work inas holding of naive prairie dogs beginning January
2012 as per the attached log. Since the most recent decontamination in December
2011i'January 2012, no infectious work has takep place in Naive prairie dogs were
moved into the area in January 2012 no infectious work occurred with these

animals from the decontamination to the period of the tours.

Naive Animal
Log-04202012.pdf

AHB has provided details on the animal housing psed throughout the containment block and

including any animals housed at the time in animal holding room ?1?34 as follows.

 

 

(0:13:42 U30. 252mm

Response: Animal housing throughout thel
following:

Ii consists of the

 

Individual ventilated caging supp",t and HEPA exhaust)
This type of caging is used to hopse prairie dogs
I Duoro units with metal cages placed (HEPA filtered exhaust)
This type of caging is used to hopse ferrets
I- Tub holding containers (This type of caging is used to house groups of prairie dogs}
Naive prairie dogs were maintained in this type of housing in Room on
February 15, 2012. 

Specia191714 Page: 793 Sean Date: 2014-09?17 COPY

8} BFO has provided the following response t5 the request for pressure trending data for each of
the rooms in the vivarium containment bldik during the time ofthe second group?s visit on
February 15, 2012. Additionally, Dr. Paul Naeechan, Director, OSHE, has conveyed that there is
no requirement to maintain trending data for pressure differential readings. Pressure
differentials are not airflows and there is n3 requirement that they be continuously monitored
andrecorded.



li'iwniiriLirn Door
Pressure DiFfere. ..

Accession Number: Specia191714 Page: 794 Sean Date: 2014-09?17 COPY

 

 

Irma;- I I 31 (C 


 
 
 
  

   
     

  

 

  

From: [El (cocrocoomser)

Sent: 07. 2009 12:42 PM .

To:  CDCICOTPERIDSNTlira (cocrocoorosepi
Subject: [3:54 at) Walk-through 1

 

i,

We are scheduled for the walk-through of th - [3334 ab on May 21. ?009. at 2:00 p.m.--meet in Lobby area, Please
note that the laboratory may actually be "hot" prior to that date based on evaluation and approval by the entity Office of
Health and Safety. .

 

Sincerely,

 

[0363242 U.S.C. 252301]

 

 

 

Centers for Disease Control and Prevention

Office of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1500 Clifton Road, NE. Mail Stop 

Atlanta. GA 30333

 

[0323142 USE. 2623M:

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use of the recipientts) named above. It may contain sensitive in fomnttion that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive ?peh information. Il'you art.- not the intended recipienlts), tuty dissemination.
distrihution. or copying is strictly prohibited. If you think you have received thiea'r in error, picture notify the sender immediately and destroy the original.

1
Accession Nomber: Specia191714 Page: 795 Sean Date: 2014?09?17 COPY

 

 (CDCIOPHPRIDSAT)

 

 

  
 

   

 

 

 

 

 

 

From:   '3 3 . 

Sent: Frida . November 05, 2010 12:38 PM

To: 

Cc: M33343 5 3 .. ?13?s?
.  tagger-3?   . 

Subject: RE: Request for Additional Informa i?n

Good Afternoon

 



Thank you for the e-mail request for additional information needed by DSAT to ensure complete review of ou 
laboratories and associated spaces in We vriil gather the requested additional information and
ensure provision within the 15-day response time~frame requested.

 

Sincerely.

 

use. a 2s2arn; 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE Mail Stop A-22

Atlanta. GA 30333

 

[0133-242 USE. 262mb}

 

 

 

 

 

'1  i= (cocropi-ipwosnr)
rida November 05, 2010 12:34 PM
fats-?42 
-  gr  
lln?i3jzz42  
Subject: Request for Additional Information

  

  
 

 

 . E. 
(cocropi-ipwosn'r)

 

 

 

U30. 262mb} I

Centers for Disease Control and Prevention
1600 Clifton Road

Atlanta, GA 30333

 

 

 

This email is in regards to the Centers renewal inspection conducted on October 12 thru 15. culminating the
week of October 13 thru 221 2010, particularly, the Laboratory and applicable areas. As stated during the
closeout brie?ng, we were going to send you a list of the we needed to validate. to clarify. and include as
information exchange in helping us to provide a compreheqsive analysis of the facility operations.

1
Accession Number: Specia191714 Page: 796 Sean Date: 2014-09-17 COPY

1.
*4

Please provide a brief summary report of the followinduitems listed below within fifteen (15) calendar days
following receipt of this email. The level of information being requested may be in the form of quality control
documents andlor reports.

ibj:r,3j::42

- . . thank you in advance for your attention given lo this matter to expeditiously move forward with this
process.

 

Cook tanks annual re-verification maintenanc? records.
Printout of 00 operations of cook tanks (biog EL
QC data for Spore testing from cook. tanks.
Air Quality data for breathing compress air.
HEPA filter and HEPA housing certification.
esc certification for
Power transition lfailure of Ventilation Systenf:
- Scheduled runs trend data with power shifts.
- HVAC trend data in power shifts during bower transition.
8. General list of PM for Research Annual re-cei?fification.
9. BAS monitoring procedures?what happens when there is a problem?
10. Verify arrangement with Emory for exposure ti?batment.

Resectfully,
i



   

 

iojzi?'; IDivision of gelect Agents and Toxins
Office of Public Health Preparedness and Response

Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A-46

Atlanta GA 1033'!

 

U.S.C. 5 252mm

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of named above. it may contain sensitive
information that is protected, privileged, or confidentiaii and it should not be disseminated, distributed, or
copied to persons not authorized to receive such information. if you are not the intended recipientr?s), any
dissemination, distribution, or copying is strictly prohibited. it you think you have received this document in
error, please notify the sender immediately and the original. Thank you.

2
Accession Number: Specia191714 Page: 797 Sean Date: 2014-09-17 COPY

 

 

From:
Sent
To:
Go:

Subject:

I?m I 


  
  

.2010 
 (CDCJOPHPRIDSAT)
- -

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

 

[00.33242 U30. 262301:

 

 

 

From:
Sent:

 

 

[02:03:

 

(cm)

 

 

 

 

eclnescla august 11, 2010 1:53 PM
   cocrocoorosem

 

   

:142 0 202801:

Walk-Th rough

Have you sent the written planrcheoklist referred to below?

 

 

[bli?l

 

 

SRA Internatlonal, ll'lC.

Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE. MS A-46



?l?lnHi-FI

 

 

[0:05]

 

 



Accession Number:

1

Page:

  

A 

798 Sean Date:

- 

2014-09-17 COPY

This document is intended for the exctusive use of the named above. It may contain sensitive information that
is protected. privileged, or confidentiai, and it should not be bisseminated, distributed, or copied to persons not authorized
to receive such information. if you are not the intended reclbientls), any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in 'Error, please notify the sender immediately and destroy the
original. Thank you.

 

 

 

.  3 (CDCIOPHPRIDSAT)
Sent: Frida ,Jul 15, 2010 5:39 PM
-   '31  . (cociocooiossp)
rcoc OPHP DSAT (cociopHpniosnr)

[0:133:42 113052022110: alk-Th rough

 
 

 

 

Looks good to me. Please thank everyone for their cooperation.

Ilbjzisj: "toils?-   I

Division of Select Agents and Toxins
Centers for DisesSe Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Alright-1 Ephraim 

 

 



 

 

 

DSAT Vision: To be the preeminent resource for the safety and security ofbiological agents and toxins.



- .. 3= (cociocootosem

16, 2010 5:10 PM
To: 
Cc:   
[bit?i ll Lbit?':
- this (CTR)
subject:  [btl ibji3}:42 U.S.C.?252aihj Wa k_Thr0ugh

 
 
 
 



    

 

 

 

 

 

 

 

Please find attached a list of attendees at this afternoon's ?Elk-through of the Building  ISuites in
the currently registered to PI, team. -The purpose of this walk-through was verification of
laborator safet and securiy measures to expand utilizatidi?l of thel Iaace to include use at
forl   virus work in addition to th? current registered purpose

 

 

 

 

  

 

AS the I [03:13:42 use. 262mb: will work on a written planlchecklist for
submission to DSAT to document the steps that Will be taken each time we tranSI ion use of the space between

.. . and use. We plan to submit the tvritten planfchecklist to DSAT within the next 2 weeks, Items
to be inctuded in the planlchecklist will include ensuring for hysical and electronic inability to open doors between active
and rooms in the facility decontar?ination procedures between uses, as well as description of
work ?ow, waste stream and insurance that studies will be to the appropriate safety level for the agent in use at
the time. Let me know if I have missed anything we discus?bd during your visit.

 

 

 

     
    

 

in I: 3'3 

File:  Ibirli?i: lof Review of Roybal Euil 
U.S.C. 2523111:

Thank you, again, for your time this afternoon in review of tl'lia locations in the 

 

Sincerely,

2
Accession Number: Specia191714 Page: 799 Sean Date: 2014-09?17 COPY

 

[b}[32242 U30. 2523
E- 2 [hl

Cenlers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE, Mail Stop 

Atlanta. GA 30333

 

U.S.C. 

 

 

 

3
Accession Nomber: Specia191714 Page: 800 Sean Date: 2014?09?17 COPY

 

Ifbff?'; I Ilbll?f. I  

 

  

 

 

 

 

 

   

 

   



From: .- Pit! 

Sent: Monday, August 23, 2010 3:02 PM 

To: ibli33242 

Cc: mils?  CDCIOPHPRIDSAT Zambuto, Laura
Katz, Jackie  


Subject: RE: Request for Information

 

Good Afternoon 

As per the email and letter attachment belowreadin the Form 3 report submitted by our entity as a result of a needle
stick to an individual in the Building  Laboratory on February 24. 2010. the following additional
information is provided as requested. 

1. Please ?nd attached the SOP that outlines the procedure for dissecting mice infected with It states
that if the procedure requires pinning of the mouse a hard will be used. It has been
signed off ersonnel currently working with in the It has also been incorporated
into the ?33334 Division Biosafety Manual on page 32.

       

 

  
 

 

2. The model of dissecting board that was obtained and that is currently in use can be found here 

SC  

3. See attachment to 1 above for evidence of retraining of personnel ourrently working with mice in the  
laboratory.

 

Please let me know if any additional information is required.

Respectfully submitted

 

I U.S.C. 2E2aih] I

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta: GA 30333

 

U.S.C. 2?2ath';

 

 

 

 

 

 

 

.  3'3 
Sent: nday, August 16, 2010 ?:09 AM
To: llibli33142 

 

 

 

 

Cc: 13535: El  
Subject: Request for Information

 

(cocrop?pnlosm

1
Accession Number: Specia191714 Page: 801 Scan Date: 2014-09?17 COPY

  



File: APHIS Request to CD usjc.
Good Morning ?1334..

 

Attached is a letter we received from APHIS last Friday. Otibe your response is prepared and signed, please send it to
me as an e-mail attachment and I will send it to APHIS and'hopefullv get this Form 3 closed. Any questions regarding the
attached letter need to be directed to myself or James Love}

 

   


Theft, Loss and Release Coordinator .
Division of Select Agents and Toxins 'i
Office of Public Health Preparedness and Response it
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS A-46

Atlanta, GA 30333

 

U30. 252mm

 

 

 




DSAT Vision: To be the preeminent resource for the-safety security of biological agents and toxins.

This document is intended for the exclusive use of the recipient named ihove. It mav contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied td persons not authorized to receive such information. If you are not the
intended recipient, anv dissemination, distribution, or copying is strictly hrohibited. If vou think vou have received this document in error, please
notify the sender immediater and destrov the original. Thank vou.

2
Accession Number: Specia191714 Page: 802 Sean Date: 2014-09-17 COPY

 

use. 252m:

 

OSEP Customer Satisfaction Survey.

 

This document is intended lor the exclusive use ofthe recipientts} named above. It may contain sensitive information Ihtil is protected, privileged. or con?dential. and it should not
be disseminated. distributed, or copied to persons not authorized to receive such information. lfyou are not the intended reeipient[s}_ any dissemination. distribution, or copying is
strictly prohibited. ll'you think you have received this document in error. please notify the sender immediately and destroy the original.

3
Accession Number: Specia191714 Page: 804 Sean Date: 2014-09?17 COPY

 

I rims? I 

 

 

 

 

 

 

 

 

 

 

 

 

 

I
From: 
Sent: er2?. 2011 12:11 PM
To: 
Cc: ?3'35P333142  
Subject: RE: reporting incidents
thil?i

 

 

 

Thank you for this clarification.

Best regards,

 

USC. 262801:

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

[03231-242 U.S.C. 252E011:

 

 

 

 

 

 

 

 

From:  (cocromearosar)
Sent: Thursday, October 27, 2011 12:09 PM
To: 333.31?? 
Cc: [has 
Subject: reporting incidents

 

 

 

 

 

 

 

Please continue to report all incidents with select agents and toxlps that have any potential for theft, loss. or release. An
informal notification in the form of an email. such as was sent Tuesday, is ?ne. The Form 3 team wishes to be informed of
all incidents and request follow up information as needed to determine whether a Form 3 will be required. There is no
penalty or negative reflection on an entity for reporting an incideq that does not require a Form 3. I encourage you to
continue notifying DSAT of any incident that occurs with select agents and toxins even if there is no apparent release.

 

 

(0:152

 

 

 

Division or select Age 1ts and Toxins

Office of Public Health Preparedness and Reaponse
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A446

Atlanta GA 30333

1
Accession Number: Specia191714 Page: 811 Sean Date: 2014?09?17 COPY

 

 

 

 
  
   

  

 

 

I
From: - 
Sent: er 2011 3:18 PM
To: 
Ce: 
(cocromrucezro ;Zambuto, Laura R. 
(cocrocoorosriE); David (cocrosasrtseepoi
Subject: FW: [El incident
[birt?i

 

 

 

  

uses 
Please see report below from 2523i?: Manager, regarding report of deviation from standard access

procedure in our todav. Let me know if any additional information is required from our entityr as a result of this
occurrence.

 

Respectfully submitted,

 

I USE. 252mm I

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A22

Atlanta, GA 30333

 

[bli33242 U.S.C. 262mm

 

 

 

 

 

 

From: (moi-:42 a  

Sent: Thursda October 2011 3:09 PM

To: I?Ieitae {cocrosesrtseppm

ibii?l Zambuto, Laura R. 3'

Howard, William (Bill) (CDCIOCOOIOSHE)
Subject: incident

 

 

. (cocrocoorosriE);

[ojzt3j::42

This Email is to provide you details of an incident involving a violation of access that happened earlier todav. At
approximater 9:40 am, Laura Zambuto and I witnessed a member ofthe ?133 3? . . groupiDivision escorting a technician
(non-CDC and on campus to install a device in USE-E into the grey area ofthe west side of the [to use the

 

 

 

 

 



 

 

 

restroom}. The technician, who was not vaccinated against - passed through the door out of the personal
shower dirty side anteroom a rnon area. There was no activitv in the grey area,
no person had exited from the [ti-?33342 labs, and the door leading to the chemical

 

decon showers was not opened. I indicated to Laura Zambuto at I would communicate this incident, and after
returnin to my office, I notified the Biosafetv Manager ?m5? of the incident and my intent of informing

'3  After hearing the details ofthe incident, Rat was of the opinion that an exposure had not take
ion of the access polio,f had. I later learned that the unvaccinated technician, who was scheduled

    
 

 

 
 

1 .
Accession Number: Specia191714 Page: 813 Sean Date: 2014?09?17 COPY

   

I: 

 
 

rose 
their

 
   

 
   

and [we - ii=-   would like to

invite ed to address their [32:4 users regarding reportable incidents at
Thursday Nov 3 at 10 AM. I 

-  ivill include you on the invitation. In light of several recent
4  tit would be helpful to have additi hat guidance and the opportunity to ask questions. The
group includes 3 [33:42 and 

I
4

 

 

If you are unavailable Thursday morning, perhaps this could be addressed during the Dec inspection ctosing
meeting or another time during this week and the ?u group Eould be invited to join this meeting.

 

 

 

{bits} i

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response 
Centers for Disease Control and Prevention .
1600 Clifton Road NE MS A46 

?tter-11c: (2h Qf'l'l'l'l

 

-.


 

 

 

.
DSAT mission: We regulate the possession. use. and transfer of select agents ind toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States. 

This document is intended for the exclusive use of the recipient named above. [trot-1y contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized receive such information. If you are not the intended recipient. any dissemination.

distribution. or copying is strictly prohibited. it you think you have received this beument in error. please notify the sender immediately and destroy the original.
I


Please consider the environment before printing this e-mail.

2
Accession Number: Specia191714 Page: 814 Sean Date: 2014-09?17 COPY

 

Itbli?} I libli?'; I 

  
   

 

 
 
      

From: - - - - 

Sent: Erida October 28, 2011 11:13 AM 

To: ioocrmomcezip}; 
I  CDCIOPHPRIDSAT) -

Cc: stresses-0- 

Subject: Re: request from Centers to addresslreportable incidents at meeting Thursday AM

Thank you We're looking forward to the opportunity for additional discussion with DSAT on this

subject.

Best regards,

(CDCIOIDINCEZID)

23, 2011 11:01 AM

(cocrOPHPRiossTSubject: RE: request from Centers to address reportable incidents at meeting Thursday have sent i a meeting invitation to meet with the Operations Group from 10:00-10:30. I look
forward to the discussion.

 

 

use. 252%;

 

 

 

 

[11}[3342 USE. 262301}

 

 



 (CDCIOPHPRIDSAT)

Sent: Friday October 28, 2011 10:59 AM
To: 5" 3' (CDCIOPHPRIDSAT)
Cc: WERE mi? litigiitiiggl (CDCIOIDINCEZID)

Subject: request from Centers to address reportable incidents at  meeting Thursday AM

I miss: I

 

  
 
 

 

 

 

 

ibii?l

 

 

 

1
Accession Number: Specia191714 Page: 815 Sean Date: 2014?09?17 COPY

Facilities Documents: 

1. - Daily checklist -
. Floor plans 
HEPA assembly map from facilities (Interstitial-spade?)
Spore test data on HEPA plenums
Spore test data on EDS
Spore test data on autoclaves 
Autoclave validation data for animal carcass run cytile times
EDS cook cycle data
Pressure decay tests .
10, Maintenance Decontamination records for PAL filters
11, Breathing air quality data
12, Daily maintenance records
13. Preventative maintenance records

mmweweww

We do request that the documents highlighted be sent to us a week prior to the site visit. Please let me know it you need
any clarification on items listed.

Thank DU.

 

use. esearn;

 

 

 

Division of Select Agents and Toxrns 1
Of?ce of Public Health Preparedness and Response

Centers for Disease Control and Prevention a
1600 Clifton Road, NE M5 n45 

Atlanta, GA 30333 i
I ibjziijciz use. a eszarnj: 

 


Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
. and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It hiay contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated. distributed. or copied. It you think you have received this document in error, please notify the sender immediately and destroy the
original, thank you.

2
Accession Number: Specia191714 Page: 816 Sean Date: 2014-09-17 COPY

 

[ti-5'5 



 

   

 

    

 

 

 

From: raging mist-r42  

Sent: Tuesda November 22, 2011 1:00 PM

To; . 

Cc; 
Subject: RE: CDC Level [5 inspection supporting documentation

Thank, we appreciate it.

Best regards,

 

I [0}[3342 USE. 2523111}

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta, GA 30333

 

tbj:r.3j::42 use. a 252mm

 

 

 

 

 

 

From: this:  

Sent: Tuesday, November 22, 2011 12:59 PM

To: H3143 [523.142, 

Cc: this: this [as


Subject: CDC Levelli] inspection supporting documentation

 

 

 

 

 

 

Hi

Please find a list (but not limited to} of documents for the upcoming inspection of the space on December 12-
16. 201 1,

general Documents: 
Biosafety Plan specific to Lev . 

Secrit Plan speci?c to Level
Security Plan

Incident Response Plan

Training Records

Access Records

lrradiator chain of custody documents
lrradiator kill curve data

. Incident report records

10. .- - - ory records

11. inventory records

 



1
Accession Number: Specia191714 Page: 817 Sean Date: 2014?09?17 COPY

This document is intended for the exclusive use of the recipient named above. It may ppntairt sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination.
distribution. or copying is strictly prohibited. It you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-mail.

3
Accession Number: Page: 819 Sean Date: 2014-09-17 COPY

Subject: RE: Centers' inspection

    

iojirijie uses

I would be glad to talk with the flu people and 252W after the closeout next week. I think the
closeout should be over by 2:30 (Start close out fneeting at 2pm if convenient for CDC)

Let me know if this is OK

libli?: I [Elf-'2'

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

 

 

[0:13:42 U30. 252aih}

 

 

 

DSAT Vision: To be the preeminent resource for tli?e safety and security of biological agents and toxins.

 

  
  
 

 

From: (CDCIOPHPFUDSAT)
Sent: 01, 2011 
To: W- cropnpwosar)

cc: WE: (CDCIOPHPRIDSAT)

 

 

 

 

Subject: Centers' inspection

 

Some weeks ago had requested that you speak with the users regarding reporting incidents. We talked
about you address this during the inspection. would like to ensure that a room is available and invite the flu
group. Would you want to schedule this after a closing meeting on Thursday (Dec 15) afternoon? Could you propose a
time or time frame on this day. or an alternate day and time

Thank you,

 

 

{pita}

 

 

 

ivision or been Age 1ts and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46
?lama GA 30333

ions:-

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents ind toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

2
Accession Number: Specia191714 Page: 820 Sean Date: 2014-09?17 COPY

 

Initial IL?bi?m I (CDCIOPHPRIDSAT)

    

 

 

 

 

   

 

From: 

Sent: ondav Deoe er 05, 2011 1:13 PM

To: mus: 

cc: mils: me; I fill-53 
Subject: RE: Centers? inspection 

 



That will send out an exit briefing request for that time.

 

ibjzij?j:

 

 

 

Also, regarding the meeting to discuss reportable events in theI [514333342L?s-05252303 I and mwitr
is there any way we might be able to schedule that for an afternoon on the 13th, or the ?319342 has
indicated that she is only available those days next week. I'm still awaiting her confirmation on the preferred date for

 gave me 2 separate options (by e-mail she indicated the 12th or
so i?ve left a voice mail message for her to clarify].

 

 

    

13m, and by voice-mail, she indicated the 13Eh or 14?"

Many thanks in advance for your assistance.

 

ibj:i3;:42 uses


     

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

 

U.S.C. 252301}

 

 

 

 

 

 

 

From: mils: 

Sent: Mon I mber 05, 2011 1:06 PM

To: ?33-33342 I.

Cc: M51 1 3 
Subject: Fw: Centers' inspection

  

 

 

 

 

How does 2PM Thursday 12,115 sound for the close out and 2:30 for the discussion of reporting incidents to 

From: 


I :1 

 

    
 

 

Sen nber as, 2011 12:52 PM
To: - ocroeHPRrossr)
Cc: (CDCIOPHPRIDSAT)

1
Accession Number: Specia191714 Page: 821 Sean Date: 2014?09?17 COPY

 

lines; I F053 I (CDCIOPHPRIDSAT)

 

From:  . 
Sent: Monda December 12, 2011 5:1? PM
To: 3W 
Subject: E: Additional info and interviews



Will do!

 

ibjf3}i42 U.S.C. 
252301}

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Cliflon Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

[013,142 USE. 252mm}

 

 

 

From: 

Sent: Monday, December 12, 2011 5:15 PM I 

To: (cocloenparosm)
Subject: RE: Additional info and interviews

Mavbe 9:30? Give my coffee a chance to kick in.

 

libli?l ?we:  I
Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

tlanta. Georaia 30333

 

[013342 U30. 2523013

 

 

 

DSAT To be the preeminent resource for the safety and security of biological agents and toxins.

 

 



 

From: ibis-=4 

Sent: Honda December 12, 2011 5:14 PM his]
. ibis: ii A 
Subject: RE: Additional info and interviews

 

Kn-sta rting at 9:00?

1
Accession Number: Specia191714 Page: 822 Sean Date: 2014-09?17 COPY

 

[5:133:42 I [0:133:42 U513. 2623 I
- 11s 1? 9 Eh;

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta, GA 30333

 

1113213342 use. 25231113

 

 

 

 

 

 

 

- i= (CDCIOPHPRIDSAT)
I ber 12, 2011 5:13 PM
this: 

   

Subject: RE ditional info and interviews

15-20 minutes will be fine.

 

Thanks
libil?i ?1203103 I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

ibii?i

 

 

 

DSAT Vision: To be the preeminent resource for the safety and seturitsir of biological agents and toxins.

 

 

 

 

 

From: this? .  (cociosasicseppo:

Sent: Monda December 12, 2011 5:13 PM 

To: Isis lib-?5" 

Subject: RE: Additional info and interviews

That sounds like a better schedule them for that time. How much time would you like me to allocate per
interview?

 

[031:33242 U.S.C. 252aih]

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop A-22
Atlanta. GA 30333

[0133242 U.S.C. 2523111} I

 

 

2
Accession Number: Specia191714 Page: 823 Sean Date: 2014-09-17 COPY

 

USE. 262:3[h]

 

 

 

 

 

 

From: 1 
Sent: Monda December 12. 2011 5:10 PM

To: ii=- 
Subject: RE: Additional info and interviews

 



I don?t think we can do these interviews tomorrow. What about Thursday morning beginning
at 9:30?

 

Iib??] I Iib??i   I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

(use:

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxinsSent: Monday, December 12, 2011 5:01 PM
To: gages?  

Cc: [bi-"15: (cocropepwosnr)
Subject: Additional info and interviews

   

 

 

 

 

 

 

Here is a list of additional documentation that we will need from your facilities group:

1. Preventative checklist we are re uesting March and September for all Suites. We have only received
fMarch;August; and May. Months do not match those requested.

2. EDS cook tank cvcle data -- These data are exactly what we need however we will need more dates. We only
received a single date for each of the three tanks.

3. Incident LogwMarch and September
4. Schedule for Preventative Maintenance on Air Handlers.

5. Schedule for Preventative Maintenance on EDS.

Names for interviews:

3
Accession Number: Specia191714 Page: 824 Sean Date: 2014-09?17 COPY

      

[b}[3}242 U.S.C. 2523

 

  

    
   
 

    
 

 

 

 

 

 

 

 

 

 

. 
l'  552315! 
I [in52  toils}
I ibji33142 
262mb}

lb} 
[tattle-12 
i 252mm
0 Animal Care technician .
I- Person who replaced I?m?42 I

. [33:42  a 3
liq 


 

lam not sure we can accomplish all these interviews tomorrow afternoon. I think and I will be tied up for quite
a while in the lab and that may run into our time slot in the afternoon to help conduct these interviews. I am not sure
how to access that potential complication. We can conduct interviews on Thursday, as we will have a less restrictive
schedule then. and i 33'? will be available tomorrow as planned. I

 

Thanks

 

 

 

Division ofSelect Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A46

Atlanta GA 20333
[blf?l

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.
This document is intended for the excluswe use of the recipient named above. It man,r contain sensitive information that is protected, privileged, or confidential, and it

should not be disseminated, distributed, or copied. If vou think vou have received this document in error, please notify the sender immediater and destrov the
original, thank vou. 

4
Accession Number: Specia191714 Page: 825 Sean Date: 2014-09?17 COPY

 

lmi'?: I 

  

 

From: ii=r 
Sent: Tuesday December 13, 2011 4:06 PM
To: [be {cocroeaparosnn
Subject: RE: Vault

Thank vou!

 

[0:133:42 U30. 262301]

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop 

Atlanta. GA 30333

 

USE. 252801}

 

 

 

 

 

From: Imi'?} Il?bi??i 
Sent: Tuesda December 13, 2011 4:05 PM
To: [bit3j::42 0333-242 

Subject: RE: Vault

 

This looks just fine. Thanks

 

Ilbfa'?} I IinB} I   I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

 

 

 

DSAT Vision: To be the preeminent resource for the safetv and security of biological agents and toxins.

  

 

 

From: 1:313:42  
Sent: Tuesday, December 13, 2011 4:04 PM
To: 03303] libil?} I 

.: I:  

 

   
 
 

   

 

 

 
   

 

 

Cc: .- cociommcezm);
(cocromrncezm); 

 

1
Accession Number: Specia191714 Page: 826 Sean Date: 2014?09?17 COPY

 

 

Good Afternoon  

 

Per your request on Monday for a statement re rdinJ the inventoryI in the vault long term storage location,
please see the statement provided below  Let me know if any additional information is needed.

Best regards,


 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

 

U.S.C. 

 

 

 

 

 

From: I (we: IICDCIOIDINCEZID)

  
 

 

 

 

 

 

 

 

mber 13, 2011 10:01 
. . nit-"5? rr?nr?rocooiosee) was:
Cc: {coc om We: (cociomincezm);
(cociotojNCEZIo);cociommcezm)

Subject: RE: Vault

The inventory program documents all movements of materials from, to, or within any long term storage

containerffacilitv. .
The last time materials were removed or placed in the vault long term storage was in 2005 when the freezer was
replaced. Since that time no entries or removals from long term storage have occurred. The vault {but not the long term

storage] was accessed in 2009, per standard operating procedures, for preventative maintenance. I
ibil?i

 

. 2 
Accession Number: Specia191714 Page: 827 Sean Date: 2014-09?17 COPY

 

 

 
 
 
 

Sent:
To:
Go:

Subject:

[03(33242 

252301]

 

 

 

[ans] Iibli?': 


 

    

 

 

 

 

ibi?rstw-S-C? 
.Annual Inspection documents

 

(spores
RE: 

 

sends his apologies-?he inadvertently attached the wrong documents in his original correspondEnce to
and pasted the reports in an effort to get them over to DSAT prior to the inspection and didn?t note that

they were 2010 reports rather than the requisite 2011 reports. Please see attachments below.

 

Sincerely,

September 201 1 

 

 

[0:133:42 U30. 262mm

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

 

 

[0:63:42 USE. 252mm

 

 

 

 

 

From:



 

 

 

(CDCIOPHPRIDSAT) .

Sent: Wednesda December 14,. 2011 1:43 

    

 

To. [0,3242

 




I'd like to have you be aware of that the 2011 documents of annual inspection conducted by Office of Health and Safety

dated 3f30f2011 only covered. The rest two sets of documents covered 

 

use. 252mm  were dated

4,11,!2010 and Silo/2010, respectively. If you have annual inspection documents for the period of October 2010~present
for all the other than I would be happy to review them tomorrow morning.

Accession NUmber:

1

Specia191714 Page: 828 Sean Date: 2014-09?17 COPY

Again, thank you so much for your assistance.

Regards.

 

[bith

 

 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Road. MS A46

we. as 1mm

 

 



 

 

USA Vision: To be the preeminent resource for the safety and security of bioiogioai agents and toxins.



This document Is intended for the exclusive use of the recipientts} named above. It may contain sensitive information that is protected. privileged. or con?dential.
and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientis}, any
dissemination. distribution. or copying is strictly prohibited. if you think you have received this document in error. please notify the sender immediately and destroy
the original. Thank you. -

Please consider the environment before printing this e-mail.

 

 

From:  (CDCIOPHPRIDSAT)
Sent: Wednesda December 14, 2011 12:Subject  Document Review Completed

  

 

 

This is a short note to inform you that Ling and I have completed the required document review of the pertinent

.- . I . . plans for the Program. Please give our sincere thanks to 
and all of those individuals behind the scene for their full participation who made doing our jobs on
a professional level ?Better?.

    

 

 

(bite:

 

 

 

 

 

 

Ling and I will see you on tomorrow (unless directed by otherwise) for the interview and closeout.
Most appreciative! 
U.S.C. 252aih} I
[an-e Division of Select Agents and Toxins

 

 

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A-46

Atlanta, GA 30333

 

 

USE. 252ath';

 

 

DSAT Vision: To be the preeminent resource for the safe@ and security ofbioiogicai agents and toxins.

2
Accession NUmber: Specia191714 Page: 829 Sean Date: 2014-09?17 COPY

This document is intended for the exciusive use of the recipientfs) named above. it may contain sensitive information that is protected. priviteged, or con?dentiat,
end it shoutd not be disseminated, distributed, or copied to persons not authorized to receive such information. it you are not the intended recipientis}, any
dissemination, distribution, or copying is prohibited. if you think you have received this document in error: pieese notify the sender immediateiv and destroy

the originat. Thank you.

3
Accession Number: Specia191714 Page: 831 Scan Date: 2014-09-17 COPY

 

fb??j

 

 

 

mite:
Division of Seiect Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE M5 A45

ittlantaI GA 30333

I (use: 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United Etates.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or con?dential, and it
should not be disseminated, distributed, or copied. If vou think you have received this document in error, please notify the sender immediatelv and destrov the

original, thank vou.

- 4
Accession Number: Specia191714 Page: 838 Sean Date: 2014-09?17 COPY

 

 

 
  
  
   
   

 

 

    
 

  

 

  

 

From: 

Sent: Thursda Ma 21, 2009 2:27 PM

To: - (CTR (CDCICOTPERIDSAT(CDCIOCOQIOSEP Koob
Stephen H. [cool-O . J.  . to;:t3;::42 I
 
I, Howard. William (Bill) (CDCIOCOOIOHS)

Subject: Lab Renovations (TLR: May 25. 200?)

 
  
 

cords that air?ow testing and balance for the HVAC modi?cations and door installation
aboratory was completed on Thursday, May 14, 2009. as per Steve Koob. Buildings and

This is to con?rm for your r.

renovation project for the 34;
Facility Of?ce.

Respectfully Submitted.

 

[b38142 U.S.C. 2?2aih}

 

Centers for Disease Control and Prevention

Of?ce of Seourity and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

 

injz-t33j::42 use. a 252mm

 

 

 

OSEP Customer Satisfaction Survey.

This document is intended for the exclusive use oi?the reoipientts) named above. it may contain sensitive information that is prolcelch privileged. or con?dential. and
it should out be disseminated. disnibuted. or copied to persons not authorized to receive such information. [fyou are not the intended reeipientis). tiny dissemination.
distribution. or copying is strictly prohibited. It?you think you have received this document in error. please notify the sender immediately and destroy the original.

1

Accession Number: Specia191714 Page: 839 Sean Date: 2014-09-17

cosy

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
    

 

 

 

 

 

 

 

 

   

 

 

 

 

L0 From JSubject Received Size Categories 1?
{:43 .. RE: Email search Mon 22222012 352 KB
0 US. . REMINDER: Email search Sun 22122012 51 KB
 . RE: Cabinet Lab Change room pictures Fri 622922012 26 KB Red Category
0% . FW: Form 3 Submission Wed 622222012  509 KB
a .. Checklist Training Tomorrow (Right after DSAT All Hands) Tue 622622012  KB
 .. Re: USA Today CDC bioterror lab safety Mon 5225(2012  2? KB
 ?13'353? .. Re: CDC facilties data Mon 622522012  15 KB
  . CDC raciities data Mon 622522012  15 KB
it}; Weyant. FW: USA Today CDC bioterror lab safety Mon 622 522012  31 KB
 Form 3 FW: Form 3 attached for 621922012 inner glove compromise Mon 622522012  29 KB
 Form 3 FW: Form 3 attached for 621922012 inner glove compromise Mon 622522012  403 KB
 a near Leadership Meeting Agenda 62 Action Items Mon 622522012  130 KB
 Form 3 FW: Preliminary report of release Fri 622222012 15 KB
L9. Cabinet Lab Change room pictures Thu 622122012  142 KB Red Category
  FW: Form 3 Continuing receipt Wed 622022012  21 KB
L31 2  RE: June 20 2012 Wed 622022012 '21 KB
 Form 3 FW: Form 3 Confirming receipt Wed 622022012  19 KB
 a Form 3 Form 3 Confirming receipt Wed 622022012  416 KB
.: . RE: Telework Wed 622022012  16 KB
 raj: . RE: Telework Wed 622022012  20 KB
tile. . FW: cot: inspection Tue 50922013  34 KB
 3 . RE: CDC Inspection Tue 621922012  2? KB
 Form 3 tit/19212: Glove tear. Bacteriology Tue 621922012  23 KB
L33 Form 3 FW: 6113! 12 - Additional pinhole found today different than suit Mon 6/1322012  21 KB
 0 Initial Noti?cation (UNCLASSIFIED) Fri 621522012 56 KB
 .. RE: training Wed 621322012  26 KB
 .. amendment Wed 621322012  23 KB
is; FW: 6213212: Glove tear in Wed 621322012  20 KB
 .. RE: training Wed 621322012  26 KB 
 RE: amendment Wed 621322012  39 KB El Red Category
 .. Automatic reply: June 13. 2012 Wed 621322012  11 KB
ME .. RE: amendment Tue 621222012  29 KB
22. .. -  amendment Tue 621222012  13 KB
 Fw; [0233142 U30. 2622020? Loss of Containment Incident Tue 621222012  24 KB
L31 0 l'  HVAC systems talk at inspectors meeting Fri 62622012 64 KB Red Category
 0 RE: Site Visit January 31 - February 1, 2012 Wed 6/6/2012 594 KB Red Category
 Guidance 06062012 BMBL 5 Checklist Tool Inspector Wed 62622012 330 KB a Red Category
ii June 6 inspector Meeting preparation Fri 62122012 636 KB Red Category
6 - .. RE: next week Thu 523122012  23 MB [5 Red Category
FW: Tick SDPs for IBC meeting this Friday Wed 523022012  9 MB  Red Category
. Report orcoc incident Thu 522422012  16 MB El Red Category
Tue 522222012 23 KB
. . RE: Request for additionai information for Amendment  Tue 522222012  50 KB
 ti Form 3 FW: squirrei- Form 3 Tue 522222012  420 KB
 a FW: glove breach last night Thu 521722012  :20 KB
 l3 FormB FW: glove breach last night Thu 521Ti?2012  69 KB
 El- He: Went site visit Wed 521622012  6'2 KB
a Form 3 FW: Form 3 Questions 2 2 KC Tue 521522012 3? KB
L53 0 Form 3 Update Fri 521122012 41 KB
 I  l. Im'n'ilri2 U-S-C- 02  my Fri 521122012 12 KB
Fw: Request for additional information for Amendment uscs Fri 521122012 153? KB

 

a 0.5.0. 6 262a

CDC oenpmosnn

 

 

 

 

1
er: Specia191714 Page:

TIZIZUIZ 10:46 AM

840 Scan Date: 2014?09?17 COPY

 

 

 

 

 

 

 

 

 

       

 

 

 

 

 

 

 

 

 

 

 

 

 

   

   
 
    
      

  

  
 

 

 

   

 

 

 

 

 

 

 

 

 

 

 

 

  

      
  

 

 

 

 

5 El lLiJlFrom lSubject Received [Size [Categories 1?
ea annom22319m
:53 ii  3e Requested documents forsite visit Thu 521022012 101 KB
  {ii  RE: Requested documents for site visit Thu 521022012 30 KB
 Form 3 FW: 5210212: Wet hip Thu 521022012  20 KB
RE: Re uested documents for site visit Thu 521022012  '25 KB
(J ?3933252 .. site visit Wed 52922012 91 KB
.. 33: U530- site visit Wed 52922012 53KB
(31 . FW site visit Wed 52922012 131 KB
 I 3'3 . RE: Requested documents for site visit Wed 52922012 39 KB
- 3 Requested documents for site visit Wed 52922012 41 KB
1:2 II 1252 Wed 52922012 33 KB
:1 3 Tue 52322012 31 KB
:33} 3 rw: Occupational Expomre Form 3 Mon 52722012 493 KB 
 El RE: Special Pathogens Inadequate round (0) Thu 52322012 01 KB El Red Categow
4 RE inadequate Part Thu 52322012 126 KB  Red Category
L31 9 Round #0 for inadequate Wed 52222012 50 K0
is; 4 - i334 Response to Request for Additional Information (21-28-1211 Wed 52222012 '22 KB
1  U-S- 32523 Second request for the Laboratory Safety and Security Plan Update Wed 422522012  2 MB El Red Category
 Form 3 FW: Potential exposure Fri 421322012 23 KB
(3 me enounm2L.aKB
 Form 3 FW: Potential exposure Fri 421322012 19 KB
 9 Laboratory Safety and SecurityI Plan Update February 2012 Tue 421022012  2 MB
:23 a [43 3: Mon 42922012 252 KB
 9 Wed 42422012 B2 KB
ti Tue 42322012 52 KB
 Tue 42322012 21 KB
 FW: 423212 - . Suit breach in the hip area Tue 42322012 21 KB
  . Update? Mon 42222012 20 KB Red Category
 3 Wed: Mattie Tue 322222012  52 KB
Form 3 3227 Glove Tear and wet foot in  Tue 322222012  23 KB
 Form 3 Tue 322222012  24 KB
Lg] Form 3 . - 33' Wed 322122012  16 KB
 Work with Wed 322122012  20 KB
.  4 primary containment barrier rooms lvlon 321922012  46 KB
2.3.. Mon 321922012  21 K3
 3T 3?3 - Mon 321922012  509 KB
 0 Most tom!    Mon 321922012  331 KB
 9 C15 . Mon 321922012  12 MB
 25333 RE: Form 3 Fri 321022012 31 KB
:53. RE: Form 3 mass? Fri 321022012 23 KB
 a Form 3 2w: Form. 2525"? Fri 321322012 231 KB
'5 Form 3 FW: Form . Fri 321622012 223 KB
 4 Fw: CDC Response to Facility' Inspection Report: [9133342 Program Wed 321422012  5 MB Red Categoryr
L-j 4 mg? . Fw: CDC Response to Facility inspection Report: Special Pathogens Wed 321422012  1 MB (3 Red Category
E3. 3. 355232 .. Updated 0542 Telephone Directory Mon 321222012  32 KB
Form 3 FW: 32322012 full-331 Suit incidents (2 events. Thursday Thu 32822012 23 KB
(:21 Form 3 FW: 32322012 - 3 '1 "3 Suit incidents (2 events. Thursday Thu 32022012 21 KB
3 . 33: Guidance on Form 3 Thu 32322012 20 KB
Form 3 Fw: Guidance on Form 3 Wed 32722012 14 KB
2. RE {3333; suit breach 327212 incident Wed 32222012 29 K3
Form 3 3v 2523?? suit breach 322212 incident Wed 32222012 2.. 13 KB
lblei'; - - -
Ac: 501%? a1 9 1 7 14 Page 8 4 1 Scan Date 2 0 14 AM

COPY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
   

 

 

 

 

 

  

 

 

 

 

 

 

 

 

 

i] Subject Received Size Categories 1?
Lg . RE: Inspection Report Responses Wed 32722012 26 KB
 . RE: Inspection Report Responses Wed 32222012 23 KB
 ScienceDaily: Top Health News Wed 32722012 53 KB
 Agenda: Wednesday File Organization Workgroup only] Tue 32622012 115 KB
:51 FW: Suit pinhole in foot bootie 326212 Tue 32622012 21 KB
 .. Fw: 322212 5uit breach Fri 32222012 211:3
i433 . Fw:iorm4 rnu 32122012 1MB
Re; Level 4 amendments Fri 221222012 25 KB
a 03.032020 FW: Amendment  Fri 221222012 22 KB 3 Red Category
 l'ibii?ir IRic.. [3&2 Amendment  Fri 221222012 13 KB
 ibiigi?ggaighso U30- Amendment 26230: Fri 221222012 22 KB
3 RE: Level 4 amendments Fri 221222012 22 KB
 . Leveldamendments Fn' 221222012 22 KB
 [hi . Re: Facilities review Thu 221022012 12 KB
 0 Form FW: Form 3 submittal Mon 221322012  202 2:3
 0 Form 3 FW: Form 3 submittal Mon 221322012  204 KB
am
Form 3 FW: Preliminary SA Release Report Wed 22322012 20 KB
 0 Initial noti?cation of a Biomishap (UNCLASSIFIED) Fri 22322012 53 KB
 Form a Fw: incident Report Tue 123122012 13 KB
Madison: Tentative Travel Mon 123022012  23 KB
 Form 3 FW: incident Report Fri 122222012 22 KB
L3 munmna mm
  RE: Suit breach in foot Thu 122522012  31 K3
 Form 3 FW: Suit breach in foot Thu 122622012  23 KB
 Weyant, FW: Report on Salmonella Outbreak Tue 122422012  22 KB
 Emailing: 06242011 +2 BMBL 5 Checklist Tool Man 122322012  5'23 KB
mm  Fw Site visit PAPR incident Fri 122022012 42 KB
  FW: 01202012 BlleL 5 Checklist Toolitlsm Thu 121922012  624 KB
. 01202012 BMBL 5 Checklist Toolitlsm Thu 121922012  624 KB
. 01112012 BMBL 5 Checklist Tool 3L4 TEST .xlsm Thu 121922012  620 KB
LJgogg?zal m?e?m??wem bnoumea nmlneomzm uka
La [hi Fur. Chemical shower wed 121322012  15 KB El Red Category
3 i: .. j:  Enginenng Core Director wed 121322012 30 KB
FW: Criminal Charges Filed in 2013tality Wed 23 KB
 .- . RE: PMAS review Fri 1221022011 4420
 . RE: and a favor Fri 30 KB
 . RE inspection raport Wed 13 KB
L3 FW: CDC Level? inspection supporting documentation Wed 20 KB
?g .5 inspection Plan Mon 233 KB
 ibii? U23 .. RE: Please let me know if you received the email with the letter Ijust Mon 35 KB
 [bli?  RE: Please let me know if you received the email with the letter [just Mon 23 KB
 DSAT IT Su .. GRAM 1021922011: Notice of Proposed Rulemaking - Foreign Wed 20 KB
 FW: Emailing: Form 3 Notification of Theft Loss or Mon 102322011  61 KB
psar Weekly - September 30. 2011 Fri 323022011 42 KB
RE: Class question Mon 022022011  23 KB
FW: Travel Status [October 1 - 143213t Quarter Travel Plans Mon 922622011  21 KB Red Category
0 FW: guidance for Form 1, section 01 Tue 02022011 420 KB 0 Red Category
 5 - guidance for Form 1. Section 6] Tue 823022011  419 KB Red Category
5?0 - . FW: F?i? 2011lnspection Calendar 071120110002 Wed 221322011  113 KB
a . Fri 321122011 100 KB El Red Category

 

 

 

Traviss,  E. (CDC2DPH 0320520) 3

Accession Number:

Specia191714 Page: 842

Scan Date:

22222012100004
2014-09-17

COPY

 

 

 
  



 

 

 

From: 3 3 

Sent: Frida Decem 2010 11:53 AM

To: an?? 

cc: . . . a ?ions: ?icjt?'; 
Subject: RE: request from lgroup during renewal inspection

Good Afternoon,

forward this request for the proposal over to

 

[b.3153

 

 

 

Sincerely,

 

I [0:133:42 U30. 252mm I

 

Centers for Disease Controi and Prevention
Select Agent Comp?iance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop 

Atlanta, GA 30333

 

USE. 2528M:

 

 

 

 

 

 

 

 

From: 

Sent: Friday, December 2010 11:5? AM

To:   

Cc: i:n;:L3;::42 I  ib3t?$ Imi'?l' I (CDCIOPHPRIDSAT)
Subject: request from  group during renewal inspection

 

 

   

 

 

 

 

[bl-1' 

 

During the renewal inspection,
concurrently. She expressed the desire to: 1} work simultaneously with
corn arison studies and 2) co-infect tissue culture cells with and human - 3' 33 . .

lto reassort with human viruses for the purpose of determining how likelyfhow much of a public risk this is. As
is a USDA agent, I forwarded this request to AHPIS.

 

 
 
  

 

APHIS is requesting you to:
1) submit a proposal for this work and
2) to include:
- any biosafety issues
- animal species and caging
- shower procedures
- waste disposal procedures
- ?oor plans and biosafetv levels of all laboratories where this work will take place
- _a description of the human '3 viruses that you intend to use

 

1
Accession Number: Page: 843 Sean Date: 2014-09-17 COPY

Upon receipt, I will forward this information to directly to APHIS. Please contact me with any questions you have
regarding this request.

 

 



 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

AI .GA 30333

(bits;

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original. -

Please consider the environment before printing this e-mail.

2
Accession Number: Specia191714 Page: 844 Sean Date: 2014-09?17 COPY

 

lose: I I'3b3i'35} I 

 

 

   

 

 

 

 

    

 

 

From:  -- 

Sent: Monday, April 02, 12 1:46 PM

To: this": We Ti

Cc: we: 3-3 was: 
we cezro)

 

 

 

 

 

30 Response to Facility Inspection Report: Special Pathogens Branch Inspection

Subject:

 

In reference to'vour e-mail request below, can you please provide additional clarification as to what you believe hasn?t
been addressed in the responses to Observations it 5 and it 10?

Thank you in advance for your assistance.

Best regards,

 33:13:42 0.3.0. 2523
Centers for Disease Control and Prevenlion

Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

 

 

 

 

13:33:42 use. a ZEEaih)

 

 

 

 

 

From: this:  (CDCIOPHPRIDSAT)

. 30, 2012 2:42 PM
 
-  

 
 

 

(CDCIOPHPRIDSAT):

 

(CDCIUPHPRIDSAT)
Subject: RE: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

 

Couid you please have the author take a look at SPB responses to Requirements #5 and #10 March Response to
December inspection document?? I think a mistake may have been made because the responses seem to be unclear.
An edited document can be submitted to me and I will update the inspection.

Thanks. Have a great weekend. 

 

    

- - .  
Sent: Wednesday, March 14, 2012 10:34 AM

1
Accession Number: Specia191714 Page: 847 Sean Date: 2014e09?17 COPY

 

 

 

 

min-'6:

 

 

 

 

    
   

 

 

 

(CDWOPH I
Cc: ibin?'; (Coqommc?zm); 1 
nu I I I i=7?

      

 

map was 
Subject: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

 

Good Morning I

 

Please find attached the CDC Response Reort to the Division of Select Agents and Toxins Facility Inspection
Report of our Special Pathogens Branc laboratory in Building

 

File: CDC Response Couerletter?SPB $133142 U.S.C.?252aih: File: DSAT FEDEX Copy SP3 Inspection Report-
.pdf File: SPB March response to December inspectiondocx File: [st-$2 incident Response

 og.doc 

 

Resciectfullv submitted,

 

ibjl33242 U30. 262:3th

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta, GA 30333

 

use. 252%;

 

 

 

2
Accession Number: Specia191714 Page: 848 Sean Date: 2014-09?17 COPY

 

 

 

     

From 

Sent 29 2012 3:(CDCIOPHPRIDSAT)
Subject: FW: Building power transfer I

 

and

Per Paul Prolast?s (BFO) e-mail below, I submit that the power transfer test performed yesterday occurred as planned
and outlined in previous correspondence to you. The test was performed without disruption in power.

Good Afternoon 3 '13?

Respectfully submitted,

 

"ib'jf3i?42 I
l] I.n 9 252Ell'h'1

Centers for Disease Control and Prevention
Select Agent Compliance, Roybat Campus
1500 Clifton Road. NE. Mail Stop A-22

Atlanta, GA 30333

 

 

$383142 U.S.C. 2523th

 

 

 

From: Probst, Paul E. (CDCIOCOOIBFO)
Sent: Thursda March 29, 2012 2:5? PM
To: 
Cc: Bowen, Ken L. (CDCIOCOOIBFO)
Subject: RE: Building power transfer

 

 

The generator load testing conducted yesterday went as planned and outtined in earlier correspondence such that
Building did not experience an interruption of power. -

Thanks,

Paul Probst

 

. 
Sent: Tuesday, March 2 012 12:17 PM
J. 

. - Imii'l'?l' I Imus: 
Subject: Building power transfer

 

 

  
    

  

. 'ibjzis'; inns:

 

 

 

 

Tomorrow Building will undergo a generator load test and the building will be transferred to generator
power during this test {please see attached CDC campus wide announcement). We are requesting records specific to
mus-42 use. 262mm laboratories during this transfer of power.

 

 

1
Accession NUmber: Specia191714 Page: 849 Scan Date: 2014?09?17 COPY

 

[bii3li42 USE. 252ath}

 

 

revs;-

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1500  Clifton Road, NE MS 

Atlanta GA 5105115}
I use. 2523.11: I

.I

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents.r hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use oi the recipient named above. It rnav contain sensitive information that is protected, privileged, or Confidential. and it
should not be disseminated, distributed, or copied. If you think vou have received this document in error, please notifv the sender immediatelv and destrov the
original, thanli you.

4
Accession Number: Specia191714 Page: 851 Sean Date: 2014-09-17 COPY

 

 

 

 

From: -  
Sent: Tuesday, April 03 [0127533 AM
To: - this: this:  icocroeneexos

   

 

    

 

 

Cc: [his [his 
me: 
Subject: RE: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

 

Yes, I believe that is the intent of the response, however I will defer back to for confirmation as well as to
request a cops,r of the updated information in the VSPB safety manual.

 

 

 

 

Best regards,
[b36142

 

 

U.S.C. 2523ih}

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop lat-22

Atlanta. GA 30333

 

littji3ji42 U.S.C. 

 

 

 

 

 

 

From: res  (cociomeniosrn)

Sent: Manda Aril 02, 2012 5:cocioeHPRiDSAT); '2 its 

[b3i63 libii?? I ?Jim: mi 

Subject: RE: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

 

   
 
 
 

 

 

 

 

 

 

We are not sure what is meant by:

The microcentrifuges are used with rotor with aerosol guard. The rotors keys, for the removai of the rotor, have been
attached to each microcentrifuge to ailow the ioading and unloading in primary containment. The safety manuai (section
14.2 A Beckman Ultracentrifuge and Beckman highspeed centrifuge, each fitted with HE PA filters, are located in a room
of each laboratory suite. Maintenance is performed as needed by staff or by Beckman representatives or 
contractors authorized to enter the Tabletop centrifuges (with aerosol guarded centrifuge buckets) and
microcentrifuges [with aerosol guarded rotor}, are also located in each laboratoryr suite. Rotors for the ultracentrifuge,
highspeed centrifuge, and microcentrifuges should be loaded and unloaded under primary containment Aerosol-
guarded buckets for the tabletop centrifuge should be loaded and unloaded under primary containment has been

1 .
Accession Number: Specia1917l4 Page: 852 Sean Date: 2014-09-17 COPY

modified to reinforce the proper use of these microcentrifuges. The Beckman Couiter Ailegra X12R bucket iids are present
in the drawers beiow with the different tubes carriers.

Does this mean:

The microcentnfuges are used with rotor with aerosoi guard. The rotors keys, for the removai of the rotor, have been
attached to each micracentrifuge to aliaw the feeding and unloading in primary containment. The safety manuai {section
24.2) has been modified to reinforce the proper use of these microcentrifuges. The Beckman Coulter Aliegra XIZR bucket
iids are present in the drawers beiow with the different tubes carriers.

A Beckman Ultracentrifuge and Beckman highSpeed-centrifuge. each fitted with HEPA filters, are located in a room of
each laboratory suite. Maintenance is performed as needed by staff or by Beckman representatives or contractors
authorized to enter the Tabletop centrifuges [with aerosol guarded centrifuge buckets) and microcentrifuges [with
aerosol guarded rotor}, are also located in each laboratory suite. Rotors for the ultracentrifuge, highspeed centrifuge,
and microcentrifuges should be loaded and unloaded under primary containment (85C). Aerosol?guarded buckets for
the tabletop centrifuge should be loaded and unloaded under primary containment.

And could we get a copy of the safety manual? If not available as a Word document, a PDF file would be fine.

Thank you-

 

 
 

From: 1   II 
Sent: Monda Aril 02, 2012 1:46 PM
(hie: 
(cocioPHPRiosrlT); 


. Subject: RE: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

 
  
  

 

    

In reference to your e-mail request below. can you piease provide additional clarification as to what you believe hasn*t
been addressed in the responses to Observations it 5 and ti 10?

Thank you in advance for your assistance.

Best regards,

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybai Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

Accession Number: Specia191714 Page: 853 Sean Date: 2014-09-17 COPY

 

[bj:r.3::42 use. 252%:

 

 

 

 

 

 

From: rm:-   lbil?i= I (CDCIOPHPFUDSAT)
Sent: Frida March 30, 2012 2:47r PM

To:  42 
cc:j'  11'?



Subject: RE: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

    
 

 

 

 

Cauld you please have the author take a look at SPB responses to Requirements #5 and #10 March Response to
December inspection document"? I think a mistake may have been made because the responses seem to be unclear.
An edited document can be submitted to me and i will update the inspection.

Thanks. Have a great weekend.'

 

 

 
 
 


March 14, 2012 10:34 Am

 
 
  
  
 

     
    



miner-r42 MW . 

Subject: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

.
- 3' 33 .

   

 

Ilbll?i: I

Good Morningl

Please find attached the CDC ReSponse Report to the Division of Select Agents and Toxins Facility Inspection
Report of our Special Pathogens Branch laboratory in Building

 

I cf: File: CDC Response Coverletter-SPB File: DSAT FEDEX Copy SPB Inspection Report-
.pdf File: SPB March response to December inspection.docx File: incident Response
logdoc 

  

Respectfully submitted,

 

[03(33142 U.S.C. 252301]

 

 

 

u- u-

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

I use. 2523.31}. I

 

3
Accession Number: Specia191714 Page: 854 Sean Date: 2014-09-17 COPY

 

Itblt?i: I Imus: I 

   
   

   
  
 
      

 

 

 

 

 

 

 

From: We 
Sent: Ma 03, 2012 7:mess-0-  
1= "in - Howard {em} {cooro
m4 (cocrocoorOSHE); -  
Zambuto, Laura R. Powell. Nathaniel
Probst. Paul E. Bowen, Ken L. lcocrocooreFO}
Subject: Today's Schedule

 

liblt?i I

 

To confirm for today, the remaining interviews will be at 9:00 am. and 9:30 am. respectively in Building 20, Room 2111
{same location as yesterday afternoon},

At 10:00 Dr. Powell will be available along with other individuals as per your request to conduct smoke testing in
the Vivarium.

 

Sincerely,
0:333:42

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

$le3-12 U30. 262aih}

 

 

 

1
Accession Number: Specia191714 Page: 860 Sean Date: 2014-09-17 COPY

 

Imus: I lib?i?i I 

 

    

From:   . .
Sent: 1 I. u. 012012016 PM

To: 
Subject: Re: Interviews

Yes, I thought I sent an e-mail earlier today indicating the interviews tomorrow would be at 9:00 am and 9:30 in 20,

Room 2111 (same as today?s location). My apologies if I didn?t forward that e-mail.

Sincerely,
[0:13:2242

 

 

     

To: m1?  
Subject: RE: Interviews

Has there been a location picked for tomorrow?s interviews vet?

Thanks

 

(meme use 
{Bl

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46
W3

[bli?l

 

 

 

 

 

 

?l uni 

 

ilo?t?}

 

 

 

DSAT 1vision: To be the preeminent resource for the safety and security' of biological agents and toxins.

 

 

 

From: their? m?   
Sent: Monda April 30, 2012 3:43 PM

  

 

 

   

To: - [bis-E: coc 
Co: 121?: it! (CDCIOPHPRIDSAT)

Subject: Interviews

 

Good Afternoon
Please see below for the interview schedule for this week?s interviews.
Individual: Dr. Nathaniel

Tuesday, May 1 Location: Building 24, Room 11-101A Time: 10:00 am.

Powell

2
Accession Number: Specia191714 Page: 861 Sean Date: 2014-09-17

COPY

Tuesday Maui location: Building 24, Room 11-101A

[b.3153

 

 

 

 

Tuesday, May 1 Location: Building 24, Room 11-101A

 

 

 

mite:

 

Tuesday, May 1 Location: Building 24, Room 11-101A

[0}[53

Time: 10:30 am.

Time: 11:00 am.

Time: 11:30 am.

 

Individual:

Individual:

 

Individual:



 

 

M5. is currently on leave of absence through June 2012 and has specifically and personally

conveyed to her line management in DSR that she does not wish to discuss matters related to the Building

facility with anyone.

Wednesday, May 2 Location: Building 20, Room 2111

 

Wednesday, May 2 Location: Building 20, Room 2111



 

Thursday, May 3 Location: To Be Provided Time:

Thursday, May 3 Location: To Be Provided Time:

Time: 1:00 pm. Individual:

Time: 1:30 pm. Individual:

 

 

uses
eaeam;

 

 

 

9:00 am. Individual:

9:30 am. Individual:

 

{0315}

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of

ARB, OSHE, BFO and the office will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 

[0:13:42 U30. 202301}

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus

1600 Clifton Road, NE, Mail Stop A-22
Atlanta,GA 30333

 

[b}[3}242 U.S.C. 262301}

 

 

 

3

Accession Number: Specia191714 Page:

862 Sean Date: 2014-09-17

COPY

 

Innis-s: I luzbiinz?} (CDCIOPHPRIDSAT)
  

 
  

  
      
    

 

 

 

 

 

 

 

 

 

From:
Sent: A ril 30, 2012 3:48 PM
To: -  CDCIOPHPRIDSAT)
Co: I 3 (CDCIOPHPRIDSAT)
Subject: Interviews
Good Afternoon
Please see below for the interview schedule for this week's interviews.
Tuesday, May 1 Location: Building 24, Room Time: 10:00 am. Individual: Dr. Nathaniel Powell
Tuesday. Mav] Location: Building 24, Room 11-101A Time: 10:30 am. Individual:
[11:16} -
Tuesday, May Location: Building 24, Room 11-101A Time: 11:00 am. Individual: ifbji?j
iblt?l?
I1:ues ay', May 1 Location: Building 24, Room 11-10111 Time: 11:30 am. Individual:

 

 

 

Ms. is currently on leave of absence through June 2012 and has specifically and personally conveyed to her
line management in 05R that she does not wish to discuss matters related to the Building facility with anyone.

 

     

Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:00 pm. lndividua :. - i i?

 

 

[017 

Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:30 pm. Individual:  HIKE)
May 3 Location: To Be Provided Time: 9:00 a.m. ndividua : (My
Thurmat? May 3 Location: To Be Provided Time: 9:30 a.m.lndividual: 

 

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of ARB, OSHE,
BFO and the ffice will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 

 Lit-Lb. El Ell
9 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

 

[mm?12 use. 252mm

 

 

 

4
Accession NUmber: Specia191714 Page: 863 Sean Date: 2014?09?17 COPY

 

lm?l I 

 

 

 

 

      

 

 

 

 
 
  
 

 

 

 

 

 

 

 

 

From:   
Sent: ednesda April 25, 2012 7:13 AM
To: (CDCIOPHPRIDSAT)
cc; Ilse: 
we: HODCIOSELSILSPP PO - I 
(CDCIOPHPRIDSAT)
Subject: RE: Meeting for April 25. 2012

We have Room 3113 in Building 20 already reserved for a meeting at 1:30, so we?ll just slide that meeting back to 2:15
and ask that we meet with DSAT in Building 20, 3113 at 1:30 if that will work with you. Several of the individuals that
were to be in attendance for the original 1:30 meeting we had the room reserved for will need to attend your meeting
anyway, so this will work well.

Many thanks in advance for your consideration of this request.

Best regards,

 

- - IEEI

Centers for Disease Control and Prevention Select Agent Compliance, Roybal Campus
1500 Clifton Road, NE, Mail Stop 

Atlanta, GA 30333

 

use. 252mm

 

 

 





ril 24, 2012 3:14 PM



Cc: [b11511 
minim mi? 


Subject: Re: Meeting for April 25, 2012

 
 
 
 

 

     

 

Thanks for your thoughtful consideration to our request. I will inform you of the specific details on tomorrow as
soon as they become known. Your gratitude and partnership in this endeavor is appreciated. Goodnight for now!

 Original Messaai  
   (cocrosrLS/stpoi

April 24, 2012 05:20 PM

(CDCIOPHPRIDSAU

 

 
 
 


Accession Nomber: Specia191714 Page: 864 Scan Date: 2014?09?17 COPY

.  - Frazier, Rodrick 
Subject: Re: Meeting for April 25, 2012

 

Where would you like to meet?
Best regards,

 

 Original Message 

From: 

Sent: Tuesday, April 24, 2012 04:03 PM

To: were 

Cc: 
Subject: Meeting for April 25, 2012

 

 

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
of the Building Virvarium Tours. Again, my apology for the short notice, and thank you in advance for your support
and considerationls] to DSAT's requests.

PS: lam not in the office at this writing, this message is being sent via my BlackBerry. Feel free to respond at your
earliest convenience. Most 

Respectfully,

 


Accession Number: Specia191714 Page: 865 Sean Date: 2014?09?17 COPY

 

IEEHEE I I 

 

 

 

 

 

From: -- -- 

Sent: . 2012 6:20 PM

To: gd?ajmjib??j 

Cc: 
wtuumu 

Subject: Re: Meeting for April 25, 2012

Where would you like to meet?

Best regards,
[0:131:12

 

 Original Message 

From: icocxoeHPch-SAT]

Sent: Tuesday, April 24, 2012 04:03 PM

To" [him [seine {cocrosesnseppop

Cc:[ 
Subiect: Meeting for April 25, 2012

 

 
  

 

Dear

My apology for the short notice, please be advised of DSAT's requests to meet with you and your staff on tomorrow at
1:30pm to discuss DSAT concerns following our review of the information received April 20, 2012, related to the incident
of the Building ?v'irvarium Tours: Again, my apology for the short notice, and thank you in advance for your support
and considerationls} to DSATs requeststhe office at this writing, this message is being sent via my BlackBerry. Feel free to respond at your
earliest convenience. Most 

Respectfully,


Accession Number: Specia191714 Page: 866 Sean Date: 2014-09?17 COPY

 

 

 

 

 
  

 

From: 0* J. 

Sent: Frida A ril2U,20124:20 PM

To:  W42 

Ce: (via? this? 
m; m5?- i

 

 

 

 

 

Ilt?3?3i343. . E35: 
Subject: CDC Resonse to DSAT Requesl of April 1 012 RE: Incidents During Visitor Tours of the
Building Vivarium

 

 

 

Good Afternoon was;

 

Per your e-mail and attached letter of April 13, 2012, please find attached the CDC response to your request for me to
provide additional information regarding incidents that occurred in the Building Vivarium during tours on February 14
and February 16, 2012.



CDC Response to
DSAT Request 

Ill 1

ll

 

Respectfully submitted,



   

 

313233242 U.S.C. 
2523011

     

I
Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop 

Atlanta. GA 30333

 

U.S.C. 252aih;

 

 

 


Accession Number: Specia191714 Page: 867 Sean Date: 2014-09-17 COPY

 

 

 

 

 

 

 

 

From: 4 J- . . 

Sent: Tuesday, April 2012 7:31 AM

To: Form 3 

Cc: this: this: licocroenenrosm}; 
this? 

Subject: Request for Information

Good Morning

 

In reference to the letter I received on April 13, 2012, ?Incidents During Visitor Tours of the Building Vivarium?, I am
requesting the following information from DSAT.

- Please provide a contact list with e-mail address and telephone numbers for each of the individuals that toured
the Building Vivarium on February 14, 2012, and February 16, 2012.

I The subject line in the letter references ?incidents? during visitor tours of the Building Vivarium and the first
bullet requests a completed Form 3 with an executive summary of events including a timeline of what occurred.
The first paragraph of your letter implies that there was one incident. more specifically, the noticeable puff of air
that was felt coming through the slit in the window out into the clean corridor. Please clarify if there is more
than one incident of concern from the tours of the Building Vivarium and whether or not more than one
Form 3 will be necessary to address multiple incidents.

0 Please indicate which individuals if any from the tour groups on February 14, 2012 and February 16, 2012 were
seen in the CDC Occupational Health Clinic or sought medical followvup elsewhere as a result of the incident.

Thank you in advance for your assistance with the information requested above.

Sincerely,

 

 

ibj:[3j::42 use. EEZaih}

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop 

Atlanta. GA 30333

 

ib}i3}:42 use. 252mm

 

 

 


Accession Number: Specia191714 Page: 868 Sean Date: 2014-09-17 COPY

 

 


 

Fr ,2012 3:45 PM
Writ-:61: 
[bli?i ibil?j: (CDCIOPHPRIDSAT .

 

 
 
    
 

 

 

 

    

   

  

  

I?m? i. 
Henderson, Joseph
ms! 
Subject: Re: Centers TLR Letter 
lam currently out ofthe office for the rest ofthis afternoon but will be ha a to respond immediateiv and
collaboratively to assist in the investigative process. Please call me a rib" a so I may begin to immediately

address actions required at this time, otherwise, I will ensure that all items requested in your attachment are addressed
by April 20, 2012.

i look forward to speaking with you this afternoon.
Sincerely,

Ilbli33:42 I f: j:

I [b}[3}242 U.S.C. 2?2alh] I

    

 

"1  (cocrOPHpr-uosm
a? A ri 3, 2012 03:0? PM

 

  
  

 

 

-   
Wigs?; were In. 

 

 

 
 

this: (CDCIOPHPRIDSAT)

 

Subject: Centers TLR Letter (2)
Good afternoon

Please be advised, the letter attachment denoted in this memo will require your immediate attention and collaboration
in helping us to understand what happen during the visitor?s tours ofthe Vivarium in Building This event qualifies as
a TLR Incident and, therefore, subject to an investigation.

Your sincere appreciation in collecting the facts Surrounding this event is most appreciative.

Respectfully,



10
Accession Number: Specia191714 Page: 869 Sean Date: 2014-09-17 COPY

 

(CDCIOPHPRIDSAT)

 

Subject: Meeting with DSAT
Location: Building 20. Room Bi 13
Start: Wed 4i?25i2012 1:30 PM
End: Wed 4l25i2012 2:00 PM
Show Time As: Tentative

Recurrence: (none)

Meeting Status: Not yet responded 

Organizer:
Required Attendees:

 

 

 

i  
in: mm

[bi-f5?
i - [0:131:42
William (Bill) (CDCIOCOOIOSHE M33142 ?3337-142
hr [we we
(cosmiomcezno).  inns: 
(CDCIOIDINCEZID): Powell, Nathaniel
Black, Carolyn Bowen, Ken L. 
Probst, Paul E. (CDCIOCOOIBFOE Monroe. Steve (CDCIOIDINCEZID)

 

 

  
  
   
  
       
   

 

[b11242
- Howar
 

 

 

 

All,

DSAT has request a meeting with us regarding the Vivarium Airflow Incident.

This meeting will take place in Building 20, Room 3113 and is scheduled for - 2:15 pm.
Thank you in advance for your availability to attend this meeting on such short notice.

The final report that was submitted to DSAT on the Vivarium Airflow Incident is attached.

?g 

Cover CDC Response to
DSHT Request 

Sincerely,

 

1
Accession Number: Specia191714 Page: 875 Scan Date: 2014-09?17 COPY

 

 

 

From:

 
   

 

 
   
 

 

 

 

  
  
  

 

 

 

Sent

To: ibii?? I x. 1

Co: "his?  
,cocrommcezlm - cocrommcezm)

Subject: Facilityl Inspection Report Response Dated: May 8, 2012

Good Morning



We received the facsimile transmission of the DSAT Facility Inspection Report Response #2012 use. and note the
request to provide copies of written records maintained of all lab episodes that did not result in exposures during 2011.

 

 

- - has indicated that she can be available on May 16 for you to stop by to review the records. Please let me
know of your availability for this opportunity to review the written records of lab episodes in 2011 that did not result in
exposures.

Regards,

 

 

use. 25221
Cl 9 [I'll

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbel Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

[bjzi3gz42 use. 252301:

 

 

 

1
Accession NUmber: Specia191714 Page: 876 Sean Date: 2014-09?17 COPY

 

lei-t6} ?are IE. (CDCIOPHPRIDSAT)

 

From: 

Sent: Wednesday, January 04. 2012 3:40 PM

To: (CDCXOPH 

Subject: Fw: AP data for emergency power transition December 20. 2011

Please forward this on to as well. just received an undeliverable notice for his receipt of the e-mail ljust sent to
you below.

any thanks,

 

 

 

From: ?1:34 Hi! 

Sent: Wednesda January 04, 2012 03:36 PM

To: ?33?3" E5 

Cc; ibj:i3j:-:42 I rb;:r3;::42 u.s.c.?2a2arn; I (bits: I 


Subject: Fw: AP data fOr emergency power transition December 20, 2011

 

 

Good Afternoon

 



Members of BFO and OSHE met with WEB: land luggag?gon our team this morning to discuss your
request for data from the December 20 emergency power transition. Please see the statement provided by Paul Probst,
BFO, as response to your request.

Respectfully submitted,

   

 

 

 



[b13342

   

. .. . Howard, William (Bill) (CDCIOCOOIOSHE)
Subject: RE: as data for emergency power transition December 20, 2011

 

Submission of data reflecting operational parameters during BFO scheduled power shutdowns is not required per the
BMBL and is not maintained. Containment barriers were in place and functioning properly. No door alarms were observed
during the power shutdown; therefore. no loss of containment. During our regular annual lab shutdowns, door
gaskets and contact area is cleaned and visually inspected for integrity. Future lab shutdowns will include smoke testing
of the APR doors on the containment perimeter.

Thanks.

Paul Probst

 

From: El. 
Sent: Tuesday, January 03, 2012 11:32 AM

1
Accession Number: Special91714 Page: 877 Sean Date: 2014-09?17 COPY

TaBowen Ken L. Probst, Paul E. Lasky, Robert D. mils?
El 

Subject: RE: op data for emergency power transition December 20, 2011

 

 

 

 

I still haven't heard anything regarding this request. Can you please help facilitate this?

Happy New Year!

From: it! (CDCIOPHPRIDSAT)

Sent: Thursda December 22, 2011 11:14 AM

Tu: We Bowen, Ken L. (cocrocooraFO);
Probst Paul E. Lasky, Robert D. CDCIOCDOIOSHESubject: Re: AP data for emergency power transition Decembe 20, 2011

 

   

   

No.

From: M4 
Sent: Thursda December 22, 2011 08:56 AM

To:

 

  
 
 
 
 

3 Bowen, Ken L. 
Probst Paul E. 3  

Cc: -. .,  -- 

Subject: RE: aP data for emergency power transition December 20, 2011

 

 

Good Morning

Has anyone responded directly to you regarding your inquiry below?

 

 

[113131142 use. 252a
in;-

   

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE. Mail Stop 

Atlanta. GA 30333

 

[13,023,242 U.S.C. 252301,

 

 

 

From: (CDCIOPHPRIDSAT)
Sent: Tue l,3,_42 mber 20, 2011 12:24 PM I I I I
were use". .- 
Bowen, Ken L. Probst, Paul E. (cocrocoorsFO); Lasky, Robert D.

 
   
 
  

   

2
Accession Number: Specia191714 Page: 878 Sean Date: 2014-09?17 COPY

(cocxocooiosHE



   
   

(cocxoenpero'sm; EEI 
Subject: AP data for emergency power transition December 20, 2011

Good Afternoon All:

During inspection last week, we discussed today's scheduled power outage, transition to emergency power, and 
trending. We would like to get copies ofoP trends for Building fl [bil33342U-3-052523ihi during this time. It?s
my understanding that the data is onlv archived for a period of a day or so.

Can vou help please help with this?

Thank vou.
[bitE]

I [bli?j- I

Division of SelectAgents and Toxins

Office of Public Health Preparedness and Response

Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A416
no. sinus

 

 

 

 

use. 252mm

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated, distributed, or copied. vaou think you have received this document in error, please notify the sender immediater and destroy the
original, thank you.

3
Accession Number: Specia191714 Page: 879 Sean Date: 2014-09?17 COPY

 

Imil?i I Ilbll?i: I 

 

 

      
       
   

 

   

 

     

 

From: -  El 

Sent: Thursda May 03, 2012 7:3? AM

To: [his DCIOPHPRIDSAT) .

oc:   

mi?i?t?S-C- 3 i? 1 .

ibii3j::42 a 1 3: 
Fifi?; Powell, Nathaniel 

Subject: FW: DSAT Information

As promised, please find 

 

?33334 Vivarium entry requirements provided below per Dr. Nathaniel Powell.

Sincerely,
ibj:[3j::42

 

 

fb3~i33242 U30. 2623ih}

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

 

U.S.C. 2528th

 

 

 

 

From: Powell, Nathaniel (CDCIOIDINCEZID)
Sent: Wednesday, May 02, 2012 3:51 PM
To:  this? 
Subject: DSAT Information

  

 

uses
252mm

 

 

 

I am providing the following information as requested. Please let me know if you need additional information.

 

Question: Specific entry requirements for the (?33342 suites when the labs are hot

 

Response: Entry requirements for the ?133*? suites when the labs are hot are dependent on studies conducted in the
specific room. The following information is provided:

  

 - Tyvek suit, PAPR with head cover bonnet, 2 pairs of gloves, inner shoe covers,
outer shoe covers, facility shoes
3 9?3 i When the Suites are hot, vaccination required for entry, Tyvek suit, PAPR
with head cover bonnet, outer shoe cover, inner shoe cover, 2 pairs of gloves, second outer smock when
handling animals, facility shoes - 
test, Tyvek suit, PAPR with head cover bonnet, inner shoe covers, outer shoe covers, facility
shoes

 

1
Accession Number: Specia191714 Page: 880 Sean Date: 2014-09?17 COPY

a Note: Rooms do not currently contain animals. Specific entry requirements will be protocol
driven. (Rabies vaccination is required when suite assigned to Rabies Program is hot.)
- Clean corridor - No PPE is required in this area

Question: Specific entry requirements for the ?333342 suites when the labs are cold

 

Response: Entry requirements for the ?33334 suites when the labs are cold include the following:

I Completion ofthe Personnel Sign In Log
in access or escort by ARB personnel

Specific entry requirements for the clean corridor areas outside of the lab suites
Response: Entry requirements for the clean corridor outside of the labs suites include the following:

1- Completion of the Personnel Sign In Log
access or escort by ARB personnel

2
Accession Number: Specia191714 Page: 881 Sean Date: 2014-09-17 COPY

 

Iona: I Iibil?i I (CDCIOPHPRIDSAT)

 

From:  
Sent: Thursda Ma 03, 2012 7'28 AM

  
 

 
 
 
   

 

To:   

cocroPHPRiosm};  my; 
this? (?re?ll   
 El - Howard William {Bill} {$1314qu
[him m::i3::42u.s.c.s2e2aih}

  
      
   

Co:

 

 

 

 

 

Probst, Paul E. Bowen, Ken L. 
Subject: Today's Schedule

 

Irma: I

 

To confirm for today, the remaining interviews will be at 9:00 am. and 9:30 am. respectively in Building 20r Room 2111
{same location as yesterday afternoon).

At 10:00 am, Dr. Powell will be available along with other individuals as per your request to conduct smoke testing in
the Vivarium.

Sincerely,

 

I use. a 262arhj: I

if 9

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

 

use. a 252mm

 

 

 

1
Accession Number: Specia191714 Page: 882 Sean Date: 2014-09?17 COPY

 

Ilbil?} I Iloll?l  .

 

  
 

  
    

 

           
  

 

From: 

Sent: Friday, June 29. 2012 3:54 PM

To: 

Cc: mus:- were I 
mils-=42- [hi?i?iu's?' 

 

 

 

 

 

 

 

 

 

 

(cocrommcmol; Ll?'c' i 2523

3 (CDCIOIDXNCEZIDE lojzl3::42 u.s.c.?2szainj:
use. 252mm IrcocrotorNCEZID)

Subject: FW: Facility Inspection Report: VSPB Request for Additional Clarification

 

 

 

Good Afternoon 3 i? 1

Regarding the outstanding facility-related items for our entity inspection report (from the 2011 inspection),
please see the e-mail below from Paul Probst to update you on the status of the installation ofthe control panel for the
EDS as well as for the "Standby Power Systems Reliability Testing? that was originally scheduled for June 2012.

I hope you have a nice weekend.

 

I use. a 252m; I

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

USE. 

 

 

 

 

From: Probst, Paul E. (CDCIOCOOIBFO)

 
   

Cc: Bowen, . (cocrocooieFO)
Subject: RE: Facility Inspection Report: VSPB Request for Additional Clari?cation


The EDS data collection system is scheduled for installation the week of July 9. We expect it to be operational the week of
July 16. We have postponed the Summer ?Standby Power Systems Reliability Testing" to August due to electrical
infrastructure work taking place in the Central Utility Plant.

Thanks,

1
Accession Number: Special91714 Page: 883 Sean Date: 2014-09?17 COPY

Paul Probst

 

 

 

From: [Wit 

Sent: Thursday, June 28, 2012 7:28 PM

To: Probst, Paul E. Howard, William (Bill) 
Subject: FW: Facility [nepection Report: VSPB Request for Additional Clari?cation

Paul,
In reference to the outstanding items for last year?s inspections in the by DSAT, do you have a date yet for the
backup power systems reliability testing for I just don't want DSAT to think we?ve forgotten about our

commitment to get this data to them.

Also, can you verify for me whether or not the EDS control panel upgrade has been completed yet to start the cfock on
the 3 month?s worth of data we need to collect and provide?

Many thanks in advance.

 

[b'jl'33242 U.S.C. 2E2aLh',?

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Hoybal Campus
1600 Clifton Road, NE, Mail Stop 

Attania, GA 30333

 

[11:13:42 use. 252m;

 

 

 

 

 

From: lei-6? Hm 

  

 

Sent: Monl If 1, 2012 1:11 PM
To: use 2523 

 
 
  

mus: ..
  missus-0- cocroSELs  
to (cocroPHP DSAT
Subject: RE: Facility Inspection Report: VSPB Request for Additional Clari?cation

    

 

   

 

I will need an email which references both items we asked for in the Inadequate Letter dated May 8, 2012 and indicates
that you will be providing such data:

1. EDS data for 3 months
2. Backup Power Systems Reliability Testing for Building scheduled for June 2012.

2
Accession NUmber: Specia191714 Page: 884 Sean Date: 2014-09?17 COPY

2. Backup Power Systems Reliability Testing for Building scheduled for June 2012.
i will archive your email and wait for formal lettets with accompanying data from each situation later this summer.

Thank you.

 

     

 

   
   

. . 
Sent: Monda Ma 21. 2012 12:01 PM
To' Traviss [bi-'53 (CDCIOPHPRIDSAT
Cc: "ii 
. 


Subject: Facility Inspection Report: VSPB Request for Additional Clari?cation

Good Afternoon

Per the attached additional request for information from the DSAT Facility Inspection Report and subsequent
responses submitted. it appears that DSAT acknowledges that the information being requested will not be
available until either June or 3 months later than our previous response submitted on April 23, 2012, Do I still
need to furnish a written response by May 22 as indicated or is this e-mail sufficient to indicate that we
acknowledge that information is still pending and will be submitted upon its availability? Please also note that
BFO has provided update that the new cook tank control panel will be installed at the earliest at the end of June
2012 which means the first 3 months of data requested should be available by the beginning of October for the
effluent decontamination system.

 

File: SPB-DSAT Raund 3 His-32' ?15p .  

 

Thank you in advance for your assistance in defining whether or not an actual written response is due to DSAT on
May 22, 2012 for the vase request.

Sincerely,

Il'ln
U30. ZBEaihj:

 

 

 

 

 


Accession Number: Specia191714 Page: 885 Sean Date: 2014-09?17 COPY

 

 klcoqoenpn/osxn

 

 


From: the: 
Sent: Thursday, May 03, 2012 5:15 PM
To: 
Subject: RE: Special Pathogens Inadequate round 
Attachments: CDC #2022 Inadequate Round #Bdoc
Categories: Red ICategory.r
Itbiti?? I Iibii?l I  if.- I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

03:113.:

 

 

 

1?1- Ivar?!" ru- 1-- 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

Frotn: 

Sent: Thursda May 03, 2012 3:21 PM
To: 
Subject: Special Pathogens Inadequate round (B)

 

I {bite} I
I [bil?l I
Division of Select Agents oner Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS ill-46

Atlanta, GA 30333
I use. 252mm

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This doCument is intended for the exclusive use of the recipient named above. It mav contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated, distributed, or copied. If vou think you have received this document in error, please notifv the sender immediate-iv and the
original, thank you.

a
Accession Number: Specia191714 Page: 886 Sean Date: 2014?09?17 COPY

 

 

From:
Sent:

To:
Subject:

CDC #2022

 

Inadequate 

A few edits

PH PRIDSA
uses

 

 

 



 

 


Wednesday, April 04, 2012 8:58 AM
E. (cocxoenpmosnn
RE: Special Pathogens Inadequate Letter

 

 

 



(meme use. 

 

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta Georgia 110333

 

 



 

 



DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

 

From: 
Sent: Wednesday, April 04, 2012 3:04 AM

TO:
CC:

 

[031133242

 



 

 

 

 

CDCIOPHPRIDSAT)
E. (CDCIOPHPRIDSAT)

Subject: Special Pathogens Inadequate Letter

File: CDC #2022 Inadequatedoc 

 

I (bite; I

 

Division ofSeiect Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS 

GA 30333

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,

 

ibii?l I

and vectors of human disease to protect the public health in the United States.

Accession Number:



Specia191714 Page: 887

Sean Date: 2014?09?17

COPY

This document is. intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated, or copied. If you think you have received this doCument in error. please notify the sender immediately and destroy the
original, thank you.

a
Accession Number: Specia191714 Page: 888 Scan Date: 2014-09-17 COPY

 

 

Irons: ?thine: I 
From: (cocxorsn anosen

Sent: Wednesdayr March 14, 2012 1:21 PM

     

To: use. 252m} 2 
Cc: PRIDSAT)
Subject: Fw: CDC Response to Facility Inspection Report: Program Inspection

 

Attachments: cor: Response lee-W osnr FEDEX Program
Inspection ReporbL?W the?. CDC Response in;ts;:42  
Inspocx; 2011 [st-its Centrifuge WSewice Agreement_
I Ina?; 51-2523 nib;:r3::42 0.8.0.5252aih; Ipmc 2011 cm:
mc zol?ols?o?i?si?sl XP.pdf

 

 

 

 

 

    

I I 
(b36142 U30. 

 

    

   

Categories: Red Category

 

Can you classify this also as Dec 12, 2012 inspection report responses for Centers? One of these is for SP3 and the other
is for

 

 

  

-- 

March 14, 2012 10:19 AM I:
- i=~r 
 . . 
Cc: . (cocrommcezm); (cocrommcezm);   4' 

ID OSELS  

'cn I the? [him-=42 
 

Subject: CDC Response to Facility Inspection Report: Program Inspection

 

 

 

 

 

 
  

 

 
    
  

 

 

 

 

bits} I

Good Morning Ii

Please find attached the CDC Response Report to the Division of Select Agents and Toxins Facility
Inspection Report of our Program laboratory in Building

 

Response lusts?03142012.pdf? DSAT FEDEX Program Inspection Report-
I

 

 

 

01:92:42 uses

252m; df>> Response Minot: team! docs? ?2011 Centrifuge
Service A reement Emil gaz?zal pm: 2011
I fly-:E-tml Wes-4d I {e000 misuse);wa 2011 Optimal XP?pdfp}

  

 

 

   

 

 

Respectfully submitted,

 

[bjf3ji42 U.S.C. 2523013

 

 

 

Centers for Disease Control and Prevention

9
Accession Number: Specia1917l4 Page: 889 Sean Date: 2014-09-17 COPY

Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Af?nnfn  

 

[bjlj3::42 USO. 252mm}

 

 

 

10
Accession Number: Specia191714 Page: 890 Scan Date: 2014-09?17 COPY

 

Ilbll?} I I  
From: 

 

 

 

 

   
 

 

Sent: Wednesday, March 14, 2012 1:20 PM

To: 01:62:42 use. 2523111; 

Cc: IE 

Subject: Fw: CDC Response to Facility Inspection Report: Special Pathogens Branch

Inspection

Attachments: - - verlettenSPB libiil3li42 u.s.c.s252ar.ni: DSAT FEDEX Copy SPB Inspection

?big??ia?l?c' .pdf; SPB March response to December inspectiondocx; Incident

Response log.doc

Categories: Red Category



 

 

 

Can you classify this as Dec 12, 2012 inspection report responses for Centers?

 

 

ibl?i?i

 

 

 

   
 
 
 

- 
March 14, 2012 10:33 AM 
the(copiosesnseppo);

 

 

 

 

 
      

- - . we 
Subject: CDC Response to Facility Inspection Report: Special Pathogens Branch Inspection

 

 

ibiL?Ei I

Good Morningl

Please find attached the CDC Response Report to the Division of Select Agents and Toxins (DSAT) Facility
Inspection Report of our Special Pathogens Branch laboratory in Building

 

Response Coverletter-SPBI more FEDEX Copy SPB Inspection Report-
lb'ii'g?ilws'c? ladf? March response to December inspectiondocxaa Incident Response logdoc?

    

252301,:

 

Respectfully submitted,

 

3:142
ll El 9' Egg 03:13:42 USE. 202mb:

Centers for Disease Control and Prevention

 

 

 

Select Agent Compliance, Roybal Campus

1600 Clifton Road, NE, Mail Stop A-22
ma GA sons

[0383142 U.S.C. 262301}

 

 

 

11
Accession Number: Specia191714 Page: 891 Sean Date: 2014-09-17 COPY

 

Irma",- I Ilbl'i?l I (c DCIOPHPRIDSAT)

     

  
 
 

 
 

 

 

 

 

 

 

 

From: 

Sent: Frida A ril13, 012 3:45 PM

To: ?3?53 

Co: ?#53 (CDCIOPHPRIDSAT -  (CDCIOPHPRIDSAT
[ti-?63 ?3'75? 
Meeohan Paul .. Henderson, Joseph
(cocrocooroseei; (oocrosasrtsepeo)

Subject: Re: Centers TLR Letter 

lam currently out of the office for the rest of this afternoon but will be happy to respond immediater and

collaboratively to assist in the investigative process. Please call me a so I mav begin to immediately

address actions required at this time, otherwise, I will ensure that all items requested in your attachment are addressed
by April 20, 2012.

I look forward to speaking with vou this afternoon.

 

 

 

Sent: Friday, April 13, 2012 03:03l PM

 

To: I [b3l3j-142 I 
Cc: (cocropnperosar); {$23,543 rm: 
more: the: minis (cocroPHPiuosm

Subject: Centers TLR Letter (2)

 

 

 

 

 

 

 

 

 

 

 

 

Good afternoon "3133342
Please be advised, the letter attachment denoted in this memo will require your immediate attention and collaboration
in helping us to understand what happen during the visitor?s tours of the Vivarium in Building This event qualifies as
a TLR Incident and, therefore, subject to an investigation.

Your sincere appreciation in collecting the facts surrounding this event is most appreciative.

Respectfully,

 

. 1
Accession Number: Special91714 Page: 892 Sean Date: 2014+09-17 COPY

 

 

 

From:

   
   

 
 
  

 

 

 

  

 

Sent
To:
Co: I - - [b3l333lJ-5-C- 
3? 3 Howard William (Bill) 
3 3 u:b}r3::42 
Zambuto, Laura R. Powell, Nathaniel
Probst. Paul E. Bowen, Ken L. (CDCIOCOOIBFO)
Subject: Today's Schedule

 

libil?l I

 

To confirm for today, the remaining interviews will be at 9:00 am. and 9:30 am. respectively in Building 20, Room 2111
{same location as yesterday afternoon}.

At 10:00 a.rn., Dr. Powell will be available along with other individuals as per your request to conduct smoke testing in
the Vivarium.

Sincerely,
[0:131:42

 

 

[0:13:42 I U.S.C. 2523
ll 9 9 m;

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta, GA 30333

 

ibjzisjzz42 use. a 252aih';

 

 

 

1
Accession Number: Specia191714 Page: 893 Scan Date: 2014-09-17 COPY

 

Imus: I  ib3l53 I 

From:
Sent
To:
Subject:

Elm 
sda iv av 02, 2012 5:15 PM
wre- (CDCIOPHPRIDSAT)

Re: Interviews

  

 

 
  

 

Yes, I thought I sent an e-rnail earlier todav indicating the interviews tomorrow would be at 9:00 am and 9:30 in 20,
Room 2111lsame as today's location}. My apologies it! didn?t forward that e-mail.

Sincerely,

 

 

From: 

Sent: Wednesdayi1

 

To: 1 3 

av 02, 2012 05:10 PM


Subject: RE: Interviews

Has there been a location picked for tomorrow?s interviews vet?

 

Thanks
IEDIEET- I libit?i I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

Ilbll?l

 



 

 

 

(bird:

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

 

 

From: Ilb??; =1 
Sent: Monda April 30, 2012 3:Subject: Interviews

 

-

I?m? 


 

 

Good Afternoon

Please see below for the interview schedule for this week?s interviews.

Tuesday, May 1 Location: Building 24, Room 11-101A

Powell

Time: 10:00 am. individual: Dr. Nathaniel

2
Accession Number: Specia191714 Page: 894 Sean Date: 2014-09?17

COPY

 

Iona: I Fills? I (CDCIOPHPRIDSAT)

 
  
 
  

El 

    

   

 

 

From:

Sent: 30. 2012 3:43 PM

To: Imil?? 

cc; - - E. (CDCIOPHPRIDSAT)
Subject: Interviews

 

Good Afternoon - 3- 

Please see below for the interview schedule for this week?s interviews.
1 Location: Building 24, Room 11-101A Time: 10:00 am. Individual: ?ll-DJ
1 Location: Building 24, Room 11-101A Time: 10:30 am. Individual:

 

 

Tuesda May 1 Location: Building 24, Room 11-101A Time: 11:00 am. Individual:

  

 

 

 

 

May 1 Location: Building 24, Room 11401101 Time: 11:30 am. Individual:

 

 

is currently on leave of absence through June 2012 and has specifically and personally conveyed to her
line management in DSB that she does not wish to discuss matters related to the Building facility with anyone.

 

Wednesday, Mavz Location: Building 20, Room 2111 Time: 1:00 pm. individual:  

  

 

 

 

 

 

 

 

 

 

Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:30 pm. 
[133.353

Thursday, May 3 Location: To Be Provided Time: 9:00 a.m.lndividual: N,

Thursday, May 3 Location: To Be Provided Time: 9:30 a.m.lndividual: I 

 

 

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of ARB, OSHE,
are and the office will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 

 

[11:13:42 Lisc. 252alnj:

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Slop A-22

Atlanta, GA 30333

 

[bjij33242 U30. 2525mm

 

 

 

4
Accession Nomber: Specia191714 Page: 895 Sean Date: 2014?09?17 COPY

 


Subject: Request for additional information for Amendment uses

seem-H-

[b13142

We are requesting the following additional information regarding Amendment 

 

 

 

 

 

 

 

 

 

1. Please provide procedures used for work with bats at #334 to include housing, handling, infecting, sample
collection, cage changing, and escaped animals. Please describe training and expertise for work with bats.

2. In Section EB, Question 1 for work performed at it is stated that RVF is the only live rus manipulated ad
that genomic material only from the flayiviruses will be manipulated. It further states that [b38142 U-S-C- 25231??
material will not be used in conjunction with "permissive" cell lines nor will any attempt be ma,_ I 
the RNAs. Please describe what measures you will use to prevent unintentional generation of,?   .

physical or temporal separation of RVF propagation (maximum quantity of 20 150 ml roller bottles),
specific cell lines used for RVF propagation].

 

 

 

 

 

 

 

3. All recombinant work and work with recombinant organisms, including in animals, usig-gyag, is required to be
performed in primary containment. Please describe how primary containment will be maintained for this work.

4. NIH Guidelines now require that BCSs discharging exhaust air back into the laboratory be certified every 6
months when used for recombinant work 'ibi3?3i?42U-5-C- Please provide in writing how you will comply with this
requirement.

 

Thank you,

 

[bit??

 

 

 

mean of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta, GA 30333

Eb} 

 

 

 

 

DSAT mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts, and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged. or
con?dential, and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. if you are not the intended
recipient. any dissemination, distribution, or copying is strictly prohibited. if you think you have received this document in error, please notify the sender
immediately and destroy the original. 

Please consider the environment before printing this e-mail.

5
Accession Number: Specia191714 Page: 896 Sean Date: 2014-09?17 COPY

 

loss: I fails? I 

  
    
 

 

      
     
   
 

 

  

 

From:  {encrocoorosepi

Sent: Frida Ma lbs, 00? 12.59 PM

To: cocrcorpearosm}

Cc: Wevant, Rob 
[bl?liu-S-C-  33 I Holt, James D,
Edwards Jac Porter, William
[Willis-OJ 

Subject: RE: Status update on discoveries

Lori,

We just received the list for the last batch being reviewed for the CASPIR site. We're still working on the records for our

storag WW We will now begin processing of the Form 2 for the transfer from the CASPIR
site to mites? U-S-C- 262m: laboratories. 

 

 

 

 

 
   

internal gel-n Compliance Branch. OSEP
Centers for Disease Control and Prevention
Atlanta GA 30333

 

[mix-:42 use. 252mm

 

 

 

 

 

 

 

 

ibtt?i
From: ocrcoTPERrosm
Sent: Frida 00? 11:5? AM
To: jib: ?1395342 (cocrocoorosero
Cc, -   mil-3:: {coercowswosnm Weyant, Rob (coucoTPERrosan; 

 

Holt, James D. (CDCIOCDDIDD)
RE: Status update on discoveries

 

On Dr. behalf, I am just checking on the status of your investigation.

Thanks.

lbit?l

 

 

 

 

FWems and Toxins 1600 Clifton Rqad MS A-46 Atlanta, GA 30333

ibll?l?

 

 

 

:ffaovw.cdc.govfodfsapi

This document is intended for the exclusive use ofthe recipient{s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipient(s}, any dissemination, distribution, or copying is strictly prohibited. Ifyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

1
Accession Number: Specia191714 Page: 897 Sean Date: 2014?09?17 COPY




Cc: (cocycorpearosm; Weyant, Rob (cchorpearosm; [coercoreeajosam ?3:324 
(cocrocoorosee); Holt, James b. (cocroeooroa).

Status update on discoveries

 

 

 

ibj:r3;::42 use. a eaearh:

 

 

 

I agree with your approaches mentioned in this email.

Thanks,



 

 

 

CDC Division of Select Agents and Toxins 1600 \Clil?tdn Road MS A-46 Atlanta, GA 30333

 

[bit?l

 

 

 



This document is intended for the exclusive use ofthe recipient(si named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseriil ated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended disiemination, distribution, er copying is strictly prohibited. lfyou
think you have received this document in error, please notify the dinder immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: 898 Sean Date: 2014?09?17 COPY

 

[cjzt?i

 

 

 

It?! 

 

 

 

 

 

        

From: I 

Sent: Tuesday, December 14. 2010 158 PM

To: 
Cc: 

Subject: Re: inspection report attached for your review

 

I have no edits for the report. i am hopeful that the departures from my incident response checklist are clear and
understandable to you and Wm}
If you need further clarification, I will be in office on Monday.
Thanksl

 

 

[0:13:42 U30. 2526ith-

 

 

 

I U.S.C. 2E2aih3 1
Centers for Disease ControIiPreveniion
OPHPR, Division of Select 
1600 Clifton Road NE

a Ga 30333

 

in:.:3::42 use. 252mm

 

 



 

 

From:  this? 

To: U.S.C. 252aih; 

Sent: Tue Dec 14 0913?:5? 2010

Subject: FW: inspection report attached for your review

 

 

   

 

[chic-12 USE.
?2?2aih?

 

 

 

Please reply and let me know if you have edits that you will be submitting or if you do not have any editsicornments for
this inspection report.

Thank you!

 

 

 

ibiiEI

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE M8 A46

Atlanta, GA 30333

ibj:i3;::42 use. see-am;

 

 

 

 

1
Accession Number: Specia191714 Page: 900 Sean Date: 2014-09-17 COPY



BEAT mission: We regulate the posseSsion. use and transfer of select agents and toxins and the importation of etioiogi-cal agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exctusive use of the recipient named above. It may contain sensitive information that is protected. privileged, or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. lfyou are not the intended recipient. any dissemination.
distribution. or copying is slrictty prohibited. if you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e?mail.

Pronul m: 

Sent: ri ay Decem 10, 2010 6:50 PM

To: (cocroeHPRrosm');
this? 
Cc: the: n?ltcocrowpnrosm; weyant. Rob (cocroeHPRross'l-J
Subject: inSpection report attached for your review

 

 

   

I toils;

 

 

Hello.

Attached is a copy of the inspection report for your review. Please note only requirementsiobsewations and
recommendations are included. the cover letter is omitted.

Some observations have been moved to other Please read through the report to look for
your observations and provide feedback.

The long dashed lines within an observation are to signify line breaks between paragraphs. will correct this in the
final report.

Due to the size. complexity. and number of people involved in this inspection. there are a few items that were not
addressed during the inspection. I have been in contact with the entity this week to follow up with these items. I am still
expecting some informationfdocumentation from them early next week. If received. I will remove the corresponding
observation or add "no further action required? depending on the circumstances. There are several citations where I am
hopeful of receiving information and being able to remove the citation and have only included a placeholder for the
observation. I will write out these observations next week if required.

If you are in the of?ce. please see me for the checklists and notes you will need to review the report.
Reminders:

1. I will need alt of you to review the report and give me your edits by COB on Tuesday. 12:14.
2. The following items have been changed on the checklists:

a. Drills and exercises are marked "yes". stated that we do not require entities to perform separate
drillsi?exercises for each building and as the extensive tabletop exercise clearly covered security and biosafety
aspects that this meets the requirement (even though there are separate plans. some aspects of plans are the same].

b. Incident response plan "procedures to be followed by employees performing rescue or medical duties" was clearly
covered in the Occupant Emergency Plan under Medical Emergencies. I apologize for missing this and asking everyone
search for it. The OEP covers all of campus including us. This was not part of the Pl speci?c IR plan asked you to
review.

Thank you for your cooperation as we move through the final stages of getting this report completed!

 

?inspection report draft 1.pdf>>

2
Accession Number: Specia191714 Page: 901 Sean Date: 2014-09-17 COPY

 

 

toils}

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road NE MS 
nta GA 30333

ibli?}

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public hearth in the United States.

This document is Intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. Ifyou think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-mail.

3
Accession Number: Specia191714 Page: 902 Sean Date: 2014-09?17 COPY

 (CDCIOPHPRIDSAT)

 

 

 

 

 

[bli??
From: 
Sent: Thursda June 07, 2012 5:22 PM
To:  
Subject: RE: Facility assessment of vivarium
Thanks,
one: 

 

 

CDC Division of Select Agents and Toxins
1600 Clifton Road MS A-46

A flaian f" A 1.0.1.11

 

[bli?]

 

 

 


?3331? i To be fire resource for the safer}: .nm'i' security agent?s and toxins.

This document is intended for the exclusive use of the recipientisi named above. It may contain sensitive information that Is
protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipientls), any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

. (CDCIOPHPRIDSAT)
Sent: Thursday, June 2012 1:38 PM
To: weyant, Rob  
Subject: Facility assessment of vivarium

 

    



File: Assessment of the Registered Building .docx 35>

1
Accession Nomber: Specia191714 Page: 904 Scan Date: 2014?09?17 COPY

Facility Assessment of the Registered Building Vivarium Space

- HVAC modi?cations to the Building vivarium meet BMBL criteria for facilities.

1- The air?ow reversal incident was transient, and the mechanical problem has been corrected.

HVAC Modi?cations to Buildin Vivarium

 

The Building vivarium is a multi-room containment block surrounded by a "clean" (non-containment)
outer corridor. Entrance to the containment suites is ordinarily via each suite?s anteroom from the clean

 

corridor, and exit is into the inneri i The original airflow design of the vivarium was
for the air to flow from the animal suite holding rooms into the inner corridor. A decision was made in early
2010 to reverse the airflow of the inner corridor so that the air would flow from this corridor into the animal
suite holding rooms. This airflow change was in strict agreement with the BMBL wording: "The direction
of airflow into the animal facility is inward; animal rooms maintain inward directional airflow compared to
adjoining hallways."

The original airflow of the inner corridor was also acceptable from a secondary containment perspective,
because air flowed inward from the clean outer corridor into the animal suite anterooms and from there into
the inner corridor. Personnel entering these areas are wearing respiratory protection and are showering prior to
exiting containment. The wording of the BMBL on directional airflow does not in general address the various
possible airflow configurations of multisroom containment blocks.

At the time of the original proposal to change the inner corridor airflow, concerns were raised by facility
personnel about a lack ofanterooms between the inner corridor and each animal suite. One concern was that
airflow disturbances could result when the doors from animal holding rooms to the inner corridor are opened.
The BMBL states for areas: Facilities should be re-verified at least modified by
operational experience.? Experience would confirm whether airflow disturbances result from Opening the inner
corridor doors, and CDCIDSAT is not aware of this problem occurring. Another concern was the possible by
personnel into another animal suite from the inner corridor after exiting an adjacent suite, which may be
construed as not being in agreement with the ?Entry into the containment area is via a
entry which constitutes an anteroomfairlock and a change room." The vivarium is not a single room
but instead is a large multi~room containment block. There are numerous facilities with multi-room
3 containment which do not have an anteroom entrance for all individual laboratory rooms but which have
entry into the overall containment area.

The results of HVAC verification tests for the vivarium, which were performed after the inner corridor airflow
modification was completed, were provided by CDC to the CDCIDSAT office, confirming that during the failure of
single exhaust fans or during a normal power failurefrestart simulation, there was no reversal ofairflow from
potentially contaminated areas into clean areas outside of containment. Exhaust fan failure testing was
performed in December 2010, and the power failurefrestart simulation test was performed in December 2011.

Accession Number: Specia191714 Page: 905 Sean Date: 2014-09?17 COPY

Airflow Reversal Incident

On February 16, 2012, an airflow reversal into the outer vivarium corridor was noted during a tour of the
vivarium by visiting inspectors from the Department of Defense. The visitors in the outer corridor felt a puff of
air from the  '2

 

252 procedure room when a laboratorian entered this room from the inner animal holding
room, and the connecting door between the two containment rooms swung closed. The procedure rooms, in
addition to anterooms, have doors which open directly to the outer corridor which are used to bring clean cages
into the suites. These containment boundary doors are equipped with a window and an opening in the window
frame that allows air to flow into the inner laboratory when the ventilation system is operating properly.

An internal investigation of the cause of the airflow reversal determined that the inner door was closing too
swiftly, resulting in a piston-like effect and a'puff of air at the outer door window frame opening. Inspectors
from the office visited the vivarium on May 3, 2012 after the inner door closer was adjusted and used
smokesticks to observe the airflow at the containment boundary doors leading directly into the animal suite
procedure rooms. One or more laboratorians sequentially entered multiple suites to open the inner connecting
doors while the inspectors made airflow observations in the'outer corridor at the boundary door windows. No
airflow reversals were observed during any of the tests performed. The mechanical problem that caused the
transient airflow reversal had been corrected, and the HUAC system serving the vivarium was verified by the
inspectors to function properly to maintain inward directional airflow under normal conditions.

Accession Number: Specia191714 Page: 906 Sean Date: 2014-09-17 COPY

 

'ibli?l 

Wednes a May 23,201211:54 AM

Annual re-verification

 

 

Annual
facility 

Dear Dr.

The list of minimum annual facility re-verification requirements is attached. The last FSAP inspection of the
Building vivarium took place 10112-1or22r201o, and the Verification policy was distributed to all
registered entities'by on 3f5f2011.

After reviewing the documentation provided of Building vivarium facility re-verification, the following required items
from the attached list were not documented:
0 Confirmation that the visual indicator of directional airflow is working properly
0 Confirmation that the decontamination systems serving the area are operating correctly
Verification that any building automation system programmed alarms are functional
- Verification that all other applicable alarms (fire, security, etc} are functional
in Documentation of routine maintenance performed on the exhaust fans serving the area
I
I

Documentation that the seals of any centrifuges located in the rooms have been checked and replaced if needed
Confirmation that any emergency showersy eyewashes and hand washing sinks are operating properly

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS ifs-4E-

Atlanta. GA 30333

 

[bili?l

 

 

 

Eur-guru. u: um- 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This doCurnent is intended for the exclusive use of the recipientis} named above. it may contain sensitive information that is protected,priviiedged. or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientis}. be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have recoived this document in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Specia191714 Page: 907 Sean Date: 2014-09-17 COPY

Annual Re?Verification - The following are the minimum veri?cation
requirements that an entity is expected to perform and document for a or
laboratory at least every 12 months. Some entities may choose to perform additional

veri?cation beside what is listed below.

a. The means of detecting air flow [tell tale, magnehelic or digital gauge, Baulin-
Tube?, etc) has been con ?rmed to accurately re?ect observed air flow. It is
recommended, but not required, that digital or magnehelic gauges be calibrated
annually.

b. Inward directional air flow has been con?rmed by observation for the laboratory.
0. Decontamination systems (autoclave, room decontamination systems, digesters,
liquid ef?uent systems, etc.) have been con?rmed to be operating correctly.

d. lfa Building Automation System has the capacity to monitor and record
performance measurements, differential pressures, the entity is encouraged to
capture and store data from potential failure events, drills, etc. This information
may provide veri?cation performance. In addition, any programmed
alarms should be veri?ed for proper functioning.

c. All alarms (fire, air flow, security, etc.) have been checked and are functioning
according to established speci?cations.

Laboratory HVAC HEPA ?lters, if present, have been certi?ed annually.
Exhaust fan motors have been checked and routine maintenance conducted.

h. The laboratory has been checked for unsealed penetrations, cracks, breaks, etc.
and these have been repaired if present.

i. All biological safety cabinets have been certi?ed annually.

j. Seals on centrifuges, Class cabinets, gloves on Class cabinets, etc. have
been checked and replaced if required.

k. Drench showers, wash stations, and hands free sinks have been con?rmed to

bf: operating prOperly.

Accession Number: Specia191714 Page: 908 Sean Date: 2014-09?17 COPY

(CDCIOPHPRIDSAT)

 

Thursoa May 03. 2012 2:10 PM

the: 

(CDCIOPHPRIDSAT): Blaine, James 
RE: Building vivarium

 

   

 

 

I talked witha few minutes ago on his way downstairs to perform a couple more interviews with CDC
facilities personnel, and he said that he has already spoken with Dr. Wevant and will be providing him with a written
report. I don't have all of the information since I have not attended all of the interviews but I can tell you that the
vivarium rooms performed without airflow reversals todav during smoke testing. and I smoked some outer
lab doors at the clean corridor while CDC personnel donned PPE and entered vivarium rooms from the central corridor.
The CDC personnel opened inner suite doors and held them open for about 15 seconds, then allowed them to close, all
while we smoked the outer doors. There were no reversals of airflow observed at the outer doors. The vivarium doors
had been adjusted after the incident occlurred.

 

 

 

From:   
Sent: Thursday, May 03, 2012 11:40 AM
To: (cocioPHpRiossT)
Subject: RE: Building vivarium

Yes, that would be great! Ithink Drs. Wevant and Dr. Blaine would also be interested, but may be planning to
debrief Dr. Wevant.

Rob is out until next week. i will be out all of next week. ill be out Mon Thurs.

 

 

 

From: lee? 
Sent: Thursda May 03, 2012 11:36 AM
To: (CDCIOPHPRIDSAT)
Subject: Building vivarium

 

msyou think you, and U-S-C- I would like me to debrief you on the vent this morning to the

Building vivarium?

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, M5 A416

Atlanta, GA 30333

inns: 

 

1
Accession Number: Specia191714 Page: 909 Sean Date: 2014-09?17 COPY

 

 

(one;

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named ahoye. It may contain sensitive information that is protectedpriviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientls}, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If yOu think you have received this document in error. please

notify the sender immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: Scan Date: 2014?09?17 COPY

 

 

 

From: 
Sent: Thursda Ma 03, 2012 7:23 AM

 

     
    
  

To:  

mil-5i mil-5? PHPRIDSAT)
fee-?- [mews-0- 
 "Howard William (Bill) [bill-?42
 - .  (CDCIOIDINCEZIDH  I
Powell, Nathaniel

 

          
   
   

Cc:

 

   

 

 

03.05 Zambulo, Laura R.
Probst. Paul E. Bowen, Ken L. (CDCIOCOOIBFO)
Subject: Today's Schedule

 

libll?l I

 

To confirm for today, the remaining interviews will be at 9:00 am. and 9:30 am. respectively in Building 20, Room 2111
(same location as yesterday afternoon].

At 10:00 Dr. Powell will be available along with other individuals as per your request to conduct smoke testing in

the 

 

"33? Viva rium.

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

[0133-242 

 

 

 

1
Accession Number: Specia191714 Page: 911 Sean Date: 2014-09?17 COPY

 

 

From: 
Sent: Wednesda May 02, 2012 3:58 PM
To:  
Subject: RE: CDC vivarium incident

 

Yes, I agree that it would be helpful for you to be on the inspection since there were facility issues.
supposed to be participating, so lam not sure what happened there.
Thanke

 

 

  


Sent: Wednesday, May 02, 2012 3:31 PM
To: I i=  (CDCIOPHPRIDSAT)

Subject: CDC vivarium incident

Hi.

has suggested that I accompany the TLR team tomorrow (Thursday) during the interviews of CDC facilities
personnel, and during smoke-testing of doors in the Building vivarium. This is a follow-up regarding the Building
vivarium airflow incident during the interagency trainee tour. The interviews will be at 9 am, and the smoke testing is
scheduled for 10 am. Because this is all directly facility related, I do think that it would be a good idea for me to attend,
and that is what I plan to do. Please let me know if that will be a problem.

   

Thank you,

 

Facility Specialist

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS lit-46

Atlanta, GA 30333

 

[0 frle 

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named above. it may contain sensitive information that is protectedpriviledged. or confidential.
and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientlsi. be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Specia191714 Page: 912 Scan Date: 2014-09?17 COPY

(CDCIOPHPRIDSAT)

 

 
     
 

 

 

From: 

Sent: Monda ,Aril 30, 2012 4:41 PM

To:' use: 

cc; libi'i?i . (CDCIOPHPRIDSAT)
Subject: RE: Interviews

Let?s meet about 0915 tomorrow to discuss these interviews

 

Innis: I lion's} I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

[bi-[El

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security' of biological agents and toxins.

 

 

 

From: I'm} 3?3 3 (CDCIOPHPRIDSAT)
Sent: Monda Aril 30, 2012 4:38 PM
To: ?13133-142 ?311314 3
El   

 
 
 

(CDCIOPHPRIDSAT)


 

   

Cc: 3* 3

 

Thank vou for your devoted appreciation and attention to putting together the interview schedules and related activities
as denoted below. This email acknowledges receipt of said noticefdocument and our gratitude for your support. Again,
thank you.

Best regard,

Ill-[tn

 
 
 
 
 

 

 

 

pril 30, 2012 3:48 PM
cocroeuprvosm); this? luncocrompwossr)

-  mire: 

 

 

 

 

 

 

Subject: Interviews

Good Afternoon
Please see below for the interview schedule for this week?s interviews.

1
Accession Number: Specia191714 Page: 913 Sean Date: 2014-09?17 COPY

Tuesday, May 1 Location: Building 2d, Room 11-101A Time: 10:00 am. Individual: Dr. Nathaniel Powell
Tuesda May 1 Location: Building 24, Room 11-10111 Time: 10:30 am. Individual:

 

  

Tuesday, May 1 Location: Building 24, Room 11-101A Time: 11:00 am. individual: [hm
[bud
Tuesay, May 1 Location: Building 24, Room 11-101A Time: 11:30 am. Individual:

 

 

 

 

-- - - - is currently on leave of absence through June 2012 and has specifically and personally conveyed to her
line management in DSR that she does not wish to discuss matters related to the Building facility with anyone.

 

 
 

 

 

 

Wednesday, May 2 Location: Building 20, Room 2111 Time: 1:00 pm. Individual:

ibd3?42

Wednesda May 2 Location: Boilding 20, Room 2111 Time: 1:30 pm. Individual


Thursday, May 3 Location: To Be Provided Time: 9:00 a.m.lndividua third:

Thursday, May 3 Location: To Be Provided Time: 9:30 a.m.lndividu

 

The smoke test that you requested to take place on Thursday morning will start at 10:00 am. Members of ARB, OSHE,
BFO and the 00?s office will be available to assist.

Other documentation that was requested in your e-mail of April 26 is forthcoming.

Sincerely,

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

 

[0023}:42 USO. 252301:

 

 

 

 

- 2
Accession Number: Specia191714 Page: Scan Date: 2014-09-17 COPY

 

Subject:
Location:

Start:

End:

Show Time As:
Recurrence:
Meeting Statue:

Organizer:
Required Attendees:

All,

(C DCIO PH PRIDSAT)

Meeting with DSAT
Building 20. Room B113

Wed 4l25l2012 1:30 PM
Wed 4252012 2:00 PM
Tentative

(none)

Not yet responded

 

I
[bil?i

 

[bil?jz

 

 

 



[hr-3H2 

r" 

3 33 33

(cocrocoorosrlei; in??  I  

(CDCIOIDINCEZID) 2



Black,

 

Probst. Paul E. 

 

52a CIOIDINCEZID)
Powell, Nathaniel

h:
Carolyn Bowen, Ken L. 


 
 
  
  
 
     
 

 

  
 
    

 
  


[blip-1d 


Irma;

use. 252%:

 

DSAT has request a meeting with us regarding the Vivarium Airflow Incident.

This meeting will take place in Building 20, Room 3113 and is scheduled for 1:30- 2:15 pm.

Thank you in advance for your availability to attend this meeting on such short notice.

The ?nal report that was submitted to DSAT on the Vivarium Airflow Incident is attached.

Cover
. .

Sincerely,

Accession Number:

 

CDC Response to
DSAT Request 

Specia191714

1
Page:

915 Sean Date: 2014-09-17

COPY

DEPARTMENT OF HEALTH 8. HUMAN SERVICES Public Health Service
Centers for Disease Control
and Prevention (CDC)

 

 

 

 I U.S.C. 252nm I

 

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Road NE, Mail Stop A46
Atlanta, GA 30333

FROM: 

Director, Division of Laboratory Policy and Practice
DATE: April 20, 2012

SUBJECT: Incidents During Visitor Tours of the Building Vivarium

The purpose of this correspondence is to provide information as requested in i
13, 2012, to the Certers for Disease Control and Prevention-Roybal Campus, 

I U.S.C. 2523th [0:13:2242 U30. 2523111}



 

 

 

 

 

 

 

 

 

As way of background I would like to describe important actions taken related to this event.

 

On February 16, 2012 (?33342 1 - of DSAT sent an email to OSHE and ARB expressing
concerns about the event in question. This email did not include anyone from the SA
Compliance Of?ce. OSHE investigated the circumstances and determined that there had been no
potential occupational exposure.

I As a result of this determination there was no of?cial noti?cation sent to DSAT.

I As a result of the email sent on April 9, 2012, additional reviews of this incident were conducted
and summary documents of the ?ndings were propared. I shared these documents with Dr.
Robbin Weyant on April i2, 2012, and he indicated that DSAT would be Opening an

 

 

  

investigation.

a On April 13, 2012 we received the email from requesting the attached response
by April 20, 2012. I

On April 2012sent an email to the Form 3 email address requesting

 

 

 

additional information related to the event as DSAT staff was present at the time of the incident.
As of Friday April 20, 2012, we have not heard back. If this incident is determined by DSAT to
be reportable, we respectfully submit we will need this information before we can proceed
further in our investigation.

1 .iman?d -x?n?m r. 

Accession Number: Specia191714 Page: 916 Sean Date: 2014-09?17 COPY

 

 


I I I 
If you requrre anything further from us please do not hesrtate to centact me Or 2mm-

 

 

 

 

 

Respectfully submitted,

_wmm

I  

   

-. a Director

Division of Laboratory Policy and Practice

Laboratory Science Policy and Practice Program Of?ce

Omce of Surveillance, Epidemiology and Laboraton Services
Centers for Disease Control and Prevention

1600 Clifton Road, NE, Mail Stop 5-56

Atlanta, GA 30333

Telephone: 404-498-6409

E?mail: Dholme32@cdc.pov

Rev. 11'2001
L: doe

Accession Number: Specia191714 Page: 917 Sean Date: 2014-09-17 COPY

The following information is provided in response to your request of April 13, 2012, RE: Incidents During
Visitor Tours of the Building Vivarium

1)

2}

Accession Nomber:

Please find attached a Form 3 along with an executive summary {narrative} of events including a
timeline of what occurred. It should be noted that a risk assessment conducted by the entity
Office of Safety, Health and Environment, the and the Program registered for use
did not indicate that a Form 3 reportable event occurred during the tours
based on the fact that Room "313??
activities and no work with virus occurred in the room between the room decontamination and
the tour dates of February 1d and February 16, 2012. In accordance with the attached DSAT
and ?3131342 HVAC verification guidance (fourth attachment below), a transient excursion
does not necessarily mean that a reversal of overall airflow for the containment block has
occurred. It should also be noted that the prairie dogs that were housed in Room - 3i 3 

time of the air puff incident on February 16, 2012, were naive prairie dogs that were transferred
into the room in January 2012 from Lawrenceville {where ARE maintains naive animals) as per
the attached log record.



 

had been decontaminated for annual facility maintenance

 

   

 

Signed Form Airflow Issue -
vivarium Airflo. .. centeg)TdL:cLEtter Narrative Summa. .. Ver' ication Gu. ..

Naive Animal

Log-04202012.pdf

ARB has provided information that the following locations were entered by the first group of
visitors on February 14, 2012.

Response: A floor plan of the vivarium is attached. I recommend contacting

to complete details on route taken on February 1d, 2012 tour. The information provided below
related to room entry was obtained by ARB staff after reviewing the Personnel Log in Sheet for
the Building Vivarium:

- Information documented on the Personnel Log Sheet indicated escorted visitors entered
1  This room was unassigned, did not have animals present and was not hot on
February 14, 2012.

El

Vrvarium_lay 1? Vivarium Log

out_usage_APR2012 __Sheet5_28N0v11-3t

 

  

Specia191714 Page: 918 Sean Date: 2014?09?17 COPY

3} ARE has provided the following information regarding work activities being performed in each of
the vivarium rooms on February 14, 2012 and February 16, 2012. The registered locations in the
Building is?? Vivarium are highlighted in yellow below.

 

I Response: The following work activities were performed in the Building Varium on
February 14, 2012 and ry 16, 2012:
3: 

[b

 

 
  

I Naive animals maintained in tubs.
[hilaiziz - i :3

 

I ibjzi3j::42 U30. 252mb} I animaIS maintained in tubs.
Room {Unassigned}
I The room was empty. The room was not hot.

0 Room Egg-g ipj:l3::42_u_s_c_

I l??aehroom was empty. The suite was not hot.
0 Room {Unassignedl

I The room was empty. The suite was not hot.

 

 

   

 

 

 

 

 

0 Road lhjziajzz42 U.s.c.?2ezaih: Im??j?y-S-C-
I Animals maintained in the room. The suite was hot.
0 RooTBi
0
Cl

 

 

4i ARE has provided that requirements to enter into the Building ?33334 Vivarium containment

block are as follows.

Response: Entry requirements are dependent on the location of the study within the vivarium.
The following information is provided:

 

1- Roomsand 3'33 Tyvek suit, PAPR with head cover bonnet, 2 pairs of gloves,
inner shoe covers outer shoe covers, facility shoes

I Room (?33342U-S-C-?ifi?i?? When the suites are hot, vaccination required for
entry, Tyvek suit, PAPR with head cover bonnet, outer shoe cover, inner shoe cover, 2 pairs

.5, second outer smock when handling animals, facility shoes

(TB) TyveI-c suit, PAPR with head cover bonnet, inner shoe covers, outer shoe covers,
facility shoes

a Note: Rooms do not currently contain animals. Specific entry
requirements will be protocol driven

a Clean corridor- No PPE is required in this area

 

   

Uses

ORO-ol'h"

 

 

S) The procedure for preventing entry of unvaccinated individuals into areas where vaccination is
required as provided by ARB is as follows.

Accession Number: Specia191714 Page: 919 Sean Date: 2014-09-17 COPY

 

$363242 U.S.C. 252mb:

 

 

 

Training

6) ARB has provided that the last time active work with infectious agents was performed in
prior to the tour by the second group as follows.

 

procedure roorn In}: 3;

Response: The last active work in was holding of naive prairie dogs beginning Januarv
2012 as per the attached log. Since the most recent decontamination in December

Naive prairie dogs were
area in January 2012 but no infectious work occurred with these

 

 

animals from the decontamination to the period ofthe tours.

Naive Animal
Log-04202012.pdf

7] ARB has provided details on the animal housing used throughout the containment block and
I including any animals housed at the time in animal holding room as follows.

 

Response: Animal housing throughout the  [bli3iz42 use. 262mm consists of the

 

following:

0 Individual ventilated caging supply and HEPA exhaust)
This type of caging is used to house prairie dogs
- Duoflo units with metal cages placed inside (HEPA filtered exhaust)
c: This type of caging is used to house ferrets
- Tub holding containers {This type of caging is used to house groups of prairie'dogsi
Naive prairie dogs were maintained in this type of housing in Room 
February 16, 2012.

 

Accession-Number: Special91714 Page: 920 Scan Date: 2014-09?17 COPY

 

8} BFO has provided the following response to the request for pressure trending data for each of
the rooms in the vivarium containment block during the time of the second group?s visit on
February 16, 2012. Additionally, Dr. Paul Meechan, Director, OSHE, has conveved that there is
no requirement to maintain trending data for pressure differential readings. Pressure
differentials are not airflows and there is no requirement that they be continuously monitored
andrecorded.

Iiliwsriurn Door
Pressure Differe. ..

Accession Number: Specia191714 Page: 921 Sean Date: 2014-09?17 COPY




vi A 123.2012 9:05 AM
on:

 

 

 

 

 

 


 CDCIOPHPRIDSAT)

Cc:  s? 


Subject: RE: Centers Inspection

According to my recollection of the meeting with Dr Weyant, this affair is to be handled as a TLR incident not a
compliance inspection. This requires that we give the entity days (which we did} to submit the written account of the
event (which they did} last Friday.

Part ofthe form 3 process involves an immediate assessment of risk to the public and to the individuals potentially
exposed to the SAT. Should it be determined that there is significant risk to either, immediate action is taken. If not,

then a deliberate process of information collection and analysis begins. We are not under the impression that there is
[0:133:42

any significant risk that the visitors to the lab in question are at risk for developin - infections. So our plans
are to finish reviewing the information we received from CDC and set up a meeting and visit this week.

 

We will confirm the date and time with and let you know.

 

Imus: ?inns:  I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

[bii?jz

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.



 

 

- ii?? 
Sent: Monday, April 23, 2012 3x10 AM
To: refs 



Subject: RE: Centers Inspection



   

Just saw - inspection will not occur today, and they have not determined when they wiil start this week.

Message-m-

  

From: (CDCIOPHPRIDSAT)
Sent: Monday. April 23, 2012 ms AM

 

  

To: the: this?  (CDCIOPHPRIDSAT) 
W- 
{cocxopHPwosnTi

   

1
Accession Number: Specia191714 Page: 922 Sean Date: 2014?09?17 COPY

Subject: Fw: Centers Inspection
Importance: High

Hi all:
Are we proceeding with the compliance inspection of Centers today? is recently back from the field, is scheduled
to participate in the lab tour, and needs a heads up to prepare. Also, I'm short-handed today, and need to coordinate



Let us know.

 


Thanks, 'l 
[bili?'i I
[bh??l

   

 

 

 

 

[bili?i

 

 

 



 Original Message 

From: 
Sent: Saturday, April 21, 2012 09:19 AM

To: 

Subject: Centers Inspection

 



 

 

 

Good morning. Just returned for Bosto a and was yondering if the inspection for Centers will still occur on Monday. 

[bjij?jz

haven't received any information from as yet. Hope you have a great weekend 

 

 

 

 

 

Banal-.- 
I

 

 

frle 

 

2
Accession Number: Special91714 Page: 923' Sean Date: 2014-09?17 COPY

(CDCIOPHPRIDSAT)

 

    
  

 

From: Elle: (CDCIOPHPRIDSAT)
Sent: Thursca A ril12,20122:42 PM

To: eel 
Cc: (CDCIOPHPRIDSAT)
Subject: Letter draft

Hi.

 

Here is some suggested wording for the letter to 

 

 

On February 15, 2012 at 3 am, DSATI 3   escorted (DSAT). 
and to the Building 3 ?3 space. Participants entered the
containment area wearing PAPRs and showered out upon exit. On February 16, 2012 at 8 am, 3 3 escorted a
second erouo to the "mi-"353 inns: libii?i I, W53 was; 

was: The second group was given the option of touring the clean corridor outside of
containment; they chose this option and did not wear PAPRs. According to escort as the second group
stood outside the door of room ?3334 in the clean corridor, the ARB technician inside opened the door to the animal
room. As this door closed, a very noticeable puff of air could be felt coming through the slit in the window out into the
clean corridor. -

 

 

 

 

 

An incident report was provided to DSAT from CDC. This report states that prairie dogs were convalescing in the
holding room after an experiment with virus. The BMBL states that all persons working in or entering
laboratory or animal care areas where activities with ?31335.2 virus are being conducted should have evidence of

 

in order to determine whether the visitors on February 15 and 16, 2012 were exposed to a select agent, please provide
the following information by COB April 20, 2012:

0 Please provide details on which rooms within the containment block were entered by the first group ofvisitors.

Provide information on the work activities being performed in all ofthe vivarium rooms during the time intervals
of the visit.

- Explain the procedure for preventing entry of unvaccinated individuals into area

1* Please confirm the last time that active work was performed in procedure room
second group.

- Provide details on the animal housing used throughout the containment block and including any animals housed
at the time in animal holding room in? i? - - -

a Previous HVAC verification test results provided to DSAT for the Building vivarium Space were qualitative and
lacked pressure trending data. Please provide pressure trending data for the vivarium containment block during
the time of the second group?s visit on February 16, 2012.

where vaccination is required.

U-S-C- 262a prior to the tour by the

  

 

 

 

[0}[El

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, N15 A46

1
Accession Number: Specia191714 Page: 925 Sean Date: 2014?09?17 COPY

Atlanta, GA 30333

 

[bli?l

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of named above. It may contain sensitive information that is protected,priviledged, or confidential,
and'it should not be disseminated, distributed. or copied to persons not authorized to receive such information. ll you are not the intended recipientis], be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error. please
notify the sender immediately and destroy the original. Thank you.

2
Accession NUmber: Specia191714 Page: 926 Sean Date: 2014-09?17 COPY

 


Sent: 2012 ?:59 PM

 

 
 

 

 

 

 

 

To: we: 

cc: (bite: [b31163 . it?; . 
[bi-"IE? 


Subject: Re: follow up to 419512012 meeting

 

We will be working to generate the information requested and wili provide it as soon as possible.

Best regards,


 

 

 

From: 1 

Sent: Thursda Aril 26, 2012 06:Subject: follow up to 4f25f2012 meeting

 

 

   

Based on our discussions yesterday, as part of our information collecting process, I would like to
request your help arranging interviews with the following people:

1) Items) I libii?l I

2) Dr Nathaniel Powell

 

 

3) 3-4 ARB workers that have duties in this ?338342 - area

4) the members of OSHE and/or BFO who participated in the most recent HVAC functional
testing of this lab {limit to 3-4 staff members from each). We do not need to interview supervisors
at this time.

We would like to meet with these individuals separately next week. if possible, we would like to
schedule 15-20 minute interviews in the early afternoon (1-2:30 pm) any day next week. Of
course, we will try to accommodate any schedule conflicts. Depending upon the final number of
individuals, we anticipate being able to finish Wednesday. But should the need arise, we can
interview people later in the week. Please send the names and proposed times that
these people can be available.

 

 

 

 

In addition, I would appreciate it greatly if you could provide me with the following
. information/documentation;

1) the date when this lab was last tested for proper airflow,

1
Accession Number: Specia191714 Page: 927 Sean Date: 2014?09?17 COPY

2} any documentation of this test,
3) the date when the lab was decontaminated prior to the reported airflow deviation,

4) any documentation regarding the decontamination procedures and verification of these
processes,

 

5] speci?c entry requirements for the . suites when the labs are hot and cold,

6) speci?c entry requirements for the clean corridor areas outside of the lab suites

My apologies if you have already provided any of this information in the documents currently
under review.

We would also like to conduct a series of relatively simple tests of airflow patterns on this lab and
several others in the same general area next week. We propose to stand outside of the
containment space in the clean corridor with smoke sticks and verify the direction of airflow while
the inner door inside the containment space is opened and closed in the same manner that
caused the anomaly observed by the visitors. We are not requesting any failure scenario testing,
any HVAC system manipulations or any other mechanical procedures to be performed during
these tests. We will need someone from either ARB or OSHE to simply open and close the inner
door for various time intervals while we observe the smoke patterns from outside of the lab area.
These activities should provide useful information about the current status of the ventilation
system function.

If possible, we would like to perform these simple tests on Thursday morning.

We appreciate your cooperation.

 

Iibjri?i I libii?j; I  I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta. Georgia 30333

 

ibjzi?}

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

2
Accession Number: Specia191714 Page: 928 Sean Date: 2014-09-17 COPY

 

3 

 

 

 

  

 

 

 

 

From: {cocropHPRiosnTJ

Sent: Tuesday. A 

To: WW5: 

Ce: few? their? use: 
one: Ills-?i5? 

 

Subject: FW: Request for Information



Please review the generated responses prepared to be sent to with the intention of addressing her
concerns denoted in her email dated Tuesday, April 2012, upon your approval. 0r otherwise, points of interest.
Please make changes as you deem necessary. Thanks.

a C1: Please provide a contact list with e-mail address and telephone numbers for each of the individuals that
toured the Building Vivarium on February 1a, 2012, and February 16, 2012.

DSAT Response: Please be advised, the intent of our mission at this stage is to gather the facts from all reliable
sources that they may be evaluated going forward to help determined the appropriate steps and course of action
that will lead to a more prudent and practical decision based on the evidence presented. At this time, it appears
circumstantial and speculative to leap forward with contacting the said individuals involved in the tours ofthe
vivarium before we have had a chance to collect and analyze the facts, is our opinion. Although we are treating this
event as top priority and carefully, we want to guard against a speedy resolution and a rush to judgment approach.

a Q: The subject line in the letter references "incidents" during visitor tours ofthe Building Vivarium and the
first bullet requests a completed Form 3 with an executive summary of events including a timeline of what
occurred. The first paragraph of your letter implies that there was one incident, more specifically, the
noticeable puff ofair that was felt coming through the slit in the window out into the clean corridor. Please
clarify if there is more than one incident of concern from the tours of the Building Vivarium and whether or
not more than one Form 3 will be necessary to address multiple incidents.

DSAT Response: Please be advised, this is our understanding of the facts as we understand them to be: "On

 

  

Februa" 555' . 12 between 8 -11:30 am. DSAT escorted 9?73
and to the Building vivarium space.

 

Participants entered the contain ent area wearing PAPRs and showered out upon exit?. In the process of your
internal investigation and you termined or find evidence that perhaps there may have been an equipment failure
with any one ofthe PAPRs worn by the first group on the then you will have to tell us whether or not this
constitute an occupational exposure 0R release of an agent outside the of the primary barriers of the
area. Depending on your findings and determination, this may or may not require a separate Form 3
for the first group of individuals. From a biosafety perspective, we want know for sure until we have evaluated all
the data and information requested.

 

Furthermore, it is our understanding W: ten 3 -11:30 am, escorted a
second group to the vivarium: ?3311531 

 

 

 

?its? IThe second group was given the option of touring the clean corridor
outside of containment; they chose this optio i not wear PAPRs. According to escort 33

second group stood outside the door of roo satis?es in the clean corridor, the ARB technician inside opened the
door to the animal room. As this door closed, a very noticeable puff of air could be felt coming through the slit in the
window out into the clean corridor?.

  
 

     
 

 

1
Accession Number: Specia191714 Page: 929 Sean Date: 2014-09?17 COPY

 

 Q: Please indicate which individuals if any from the tour groups on February 14, 2012 and February 16, 2012
were seen in the CDC Occupational Health Clinic or sought medical follow-up elsewhere as a result of the
incident.

DSAT Response: We have not been made aware of any individuals from either the first group or second group that
toured the vivarium on the dates in question having received or sought medical treatment nor any medical

surveillance being initiated.

we hope this helps to answer your concerns, if we can be of further assistance, please don?t hesitate to
contact our office.

Respectfully,

The Form 3 Management and Team

 

[0:132:42 USE. 262301}

 

 

 

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd. NE, Mailstop A-AE

Atlanta, GA 30333

I use. 2s2atn; I

 

DSAT Vision: To be the preeminent resource for the safety and security ofbioiogicoi agents and toxins.

This document is intended for the exciusive use of the recipientts) named above. it may contain sensitive intomtatiori that is protected, pdviteged, or contidentiai,
and it shoutd not be disseminated. distributed, or copied to persons not authorized to receive such infom'iation. ifyou are not the intended recipientfs), anyr
dissemination. distnbution, or copying is prohibited. if you think you have received this document in erroc please notify the sender immediateiy and destroy
the on?ginai. Thank you.

 

From: Form 3 (CDC)

Sent: Tuesday, April 17, 2012 7:31 AM
(cociopHPRiosnT); ?13314..

(CDCIOPHPRIDSAU

      

Sent: Tuesday, April 2012 2:31:05 AM Eastern Time (US Canada)

To: Form 3 CDC

Cc: 
Subject: Request for Information

 

Good Morning - it 

In reference to the letter i received on April 13, 2012, ?Incidents During 'v'isitor Tours of the Building Vivarium?, I am
requesting the following information from DSAT.

2
Accession Number: Specia191714 Page: 930 Sean Date: 2014-09?17 COPY

 

0 Please provide a contact list with email address and telephone numbers for each of the individuals that toured
the Building Vivarium on February 14, 2012, and February 16, 2012. 

a The subject line in the letter references ?incidents? during visitor tours of the Building Vivarium and the first
bullet requests a completed Form 3 with an executive summary of events including a timeline of what occurred.
The first paragraph of your letter implies that there was one incident, more specifically, the noticeable puff of air
that was felt coming through the slit in the window out into the clean corridor. Please clarify if there is more
than one incident of concern from the tours of the Building Vivarium and whether or not more than one
Form 3 will be necessary to address multiple incidents.

in Please indicate which individuals if any from the tour groups on February 14, 2012 and February 16, 2012 were
seen in the CDC Occupational Health Clinic or sought medical follow-up elsewhere as a result of the incident.

Thank you in advance for your assistance with the information requested above.

Sincerely,
[bj:3:4 

 

 

Itb?i31142  use. 
llcit" S9 252al'l'l?.

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop 

Atlanta, GA 30333

 

?1:133:42 U30. 252mm

 

 

 

3
Accession Number: Specia191714 Page: 931 Sean Date: 2014-09-17 COPY

From:
Sent
To:

Cc:
Subject:

 

 

 

 

I noticed a discrepancv in the dates I previously provided Dr Wevant. Here is a table wit the names and correct

?33314 tours in 

 

datesftimes for the participants to the

Name A
12 -11:

2 16 

12- 

 

From: 
Sent: Thursday, Ari! 12, 2012 12:38 PM
To: ?1345? - CDCIOPHPRIDSAT)
Cc: 3' 3' (CDCIOPHPRIDSAT)
visitor information

   
 
  

 

 

 

Could vou please provide me with the names of all DSAT personnel and interagencv trainees who participated in the

 

toUr date 3: time

Building tours on February 15 and 16, 2012? also need the a roximate time of day for each tour. A request
for information letter is being drafted which will be sent to the Centers tomorrow, and your information will be

helpful in drafting this letter.

Thank you,

 

[b?t?jz

 

 

 

uni-V1. guru-u..-

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS lit-45

Atlanta, GA 30333

 

[blf?j

 

 

 


Accession Nomber: Specia191714 Page:

932 Scan Date:

2014?09-17

COPY

 

Iibli?}

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientis] named above. It may contain sensitive information that is protectedpriyiledged, or con?dential,
and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientis}, be aware
that any disclosme, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error. please
notify the sender immediately and destroy the original. Thank you.

- 2
Accession Number: Specia191714_ Page: 933 Sean Date: 2014-09-17 COPY



 

From: the 
Sent: Thursda Aril 12, 2012 1:09 PM

To:  (CDCIOPHPRIDSAT)
Subject: 3W: Request for DSAT Training

 

 

From: mtcociopnpwosm

Sent: Manda Aril 09, 2012 4:02 PM

To: flit-5'1 Weyant, Rob 
Cc: .-  3 (CDCIOPHPFUDSAT)

Subject: FW: Request for DSAT Training

Dr Weyant and

I thought lhis would be of your interest. I have another email from - 
DSAT in future training sessions. I am nol sure what exactly happened since that email

 
 

 

 

 

 

From: Isle? lie-51 If?: I (cociommcazm)

Sent: Mon ril 09, 2012 3:4? PM

To: mils" . Powell, Nathaniel (CDCJOIDINCEZID) 3 .3
Cc: Frieden, Thomas (Tom) riff-53  

     
 

 



    

 

Williams, Allison (cocioromcazro); eggs: rages: m  (cocyofoiu
(cociocooiosna)
Subject: RE: Reducet for DSAT Training

 

poof of air in the face from a 1% lab while standing in the clean corridor in the face I will not be able to accommodate

our request at this time. The totally ridiculous response received from Safety and DSAT ?(it doesn't matter if th
Ugh-f3 2 lab blows positive into the clean corridor as long as it is not sustained"- said in front of 16 people} coupled with the
fact that I was promised a written statement reiterating the response and none has appeared; I will no longer invite or
accept external trainees in this area. I fear for their safety and know. without a shadow of doubt. that CDC Safety and
DSAT will do anything (including withholding the truth and trying to silence or discredit anyone that speaks up about
serious safety concerns regarding themselves or others} to hide the fact that we have serious problems with the airflow
and containment in this whole building. 

  

 

I further believe that CDC has in their possession, reports that clearly demonstrate the airflow reversal project should have
included ante-rooms {which were not built) and that OHS has claimed the fan failure-test to be a success even though the
numbers were clearlyr showing -2.D negative static pressure and in order for the test to have succeeded at least -3.0 of
negative static pressure in the duct system would have been maintained with one fan running.

I am totally horrified and dismayed at the events surrounding safety and the fact that even though this has been taken
clear up the chain of command all the way to Dr Frieden. no one is willing to admit the mistake or more importantly fix it.
There have been several reports that verify my concerns but they are squashed as well as anyone that tried to speak up.
CDC touts this as the most advanced bio-containment facility in the world- have no doubt that that was the intention. but
as long as you have people scared to tell the truth about concerns. it will never be.

Again. my apologies for not being able to assist you at this time; however safety is paramount to me and I will not sacrifice
my integrity to cover up what I believe is wrong.

1
Accession Number: Specia191714 Page: 934 Sean Date: 2014-09?17 COPY

 

 

[bll?l I

 

 

Animal Resources Branch
National Center for Emerging and Zoonotic Infectious Diseases

 

[bil?l

 

 

 

 

 

. 3" 3? (CDCIOPHPRIDSAT)
Sent: Monday, April 09, 2012 10:49 AM
To: Powell, Nathaniel 
cc: Imus: ?Ems: limits: ?initial  
Subject: Request for DSAT Training

 

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to schedule a
training session for the last week oprril, 2012 for DSAT FTEs {5 participants). lam waiting to hear back from

rm?  to decide on an exact date. To answer your question: the recluirements to enter the last time
were TB test and proof of program;' respiratory fit test. Again thank you for y0ur support.

 

2
Accession Number: Special91714 Page: 935 Sean Date: 2014-09?17 COPY

 

 

 
   

From: mils?  
Sent: PM

To: oociroeHPBlosATi

Co: I - - (GobloeHPBlosAT)
Subject: Fw: Airflow in 

 

Here you go



 

 

 

 

 

Below is the email [and his response} that I sent to ?33334  {and copied AFIB personnel) on the day of nor last
training event. ckton did not send me any more informatic?glt euess he as been in contact with

and other ARB personnel. I also read the memo from. i and do not know who in DSAT she is
referring to, however I am sure she would tell you if you asked. Does thelm?g?giig  i 

?3135342 have any information? I will
be back in the office on Friday, but until then, I will answer emails when I can.

 

 

 

 

 

From: (coclocoolosnel

 

 

 

Sent: Thursda February 16, 2012 4:16 PM

To: Ellie? 

Cc: Powell, Nathaniel Williams, Allison


Subject: Re: Air?ow in 

Thanks we will look into it.

 



Sent: Thursda February 16, 2012 04:13 PM

To: [b13342 [bill3142 

Cc: Powell, Nathaniel Imil?? ?331133
(CDCIOIDINCEZID)

Subject: Air?ow in 

 

[bil?l

 

Williams, Allison

Good afternoon et al

This morning I was a part of an escorted group that walked through ofthe clean areas in the Vivarium of Bldg. and
wanted to make you all aware ofa circumstance that the group encountered.

1
Accession Number: Specia191714 Page: 936 Scan Date: 2014-09?17 COPY

 

As the group stood outside the door of 3 3 in the clean corridor, the ARB technician inside opened the door to the
animal room. As the door closed a very noticeable puff of air could he felt coming through the slit in the window out
into the ?clean? corridor. 1 was told by that this room does not house infected animals at the present time.

[b 

 

 

 

FYI

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers to Disease Control and Prevention

1600 Clifton Rd. NE MS A46

333
mire;-

Vision: To be the preeminent resource for safety and security of bioiogicoi agents and toxins.

 

 

2
Accession Number: Specia191714 Page: 937 Sean Date: 2014?09?17 COPY

(CDCIOPHPRIDSAT)

 
 

 

 

 

 

    

 

From: Bowen, Ken L. 

Sent: Monda December 26. 2011 7:30 PM

To: .
Wives-C- 

Cc: ?Eff ?*ul E. (CDCIOCOOIBFO Howard. William {Bill} was:

Weyan ob



Subject: Vivarium airflow tests

Thanks for you help too.
Thanks Again.

Ken Bowen .

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax

 

 

From: re?t (CDCIOPHPRIDSAT)

sda December 22, 2011 10:12 AM

is ?13:4 


-- (cocrocooxsFO); Howard, William (Bill) (cociocoor05HE); Bowen, Ken L. (cociocoorBFO);
Weyant, Rob (cocmpupryosm;
(CDCIOPHPRIDSAT)

Subject: RE: Vivarium air?ow tests

         

053-51" 

   
  

 

 

 

The HVAC verification of the select agent registered space at your facility has been successfully completed.
I would like to express my very sincere thanks to everyone invoived in the extensive work needed to perform and
document these tests. ?thank you all very much, and I hope that everyone has a Merry Christmas.

Yours trulv
ibii??:

 

 

 

 

Centers for Disease Controi and Prevention

Office of Public Heaith Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS 

Atlanta, GA 30333

 

rims:

 

 

 

1
Accession Number: Specia191714 Page: 938 Sean Date: 2014-09-17 COPY

 

 

[bli??

 

 

vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the named above. It may contain sensitive information that is protectedbriviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientisi, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

 

From: Lasky, Robert D. (CDCIOCOOIOSHE)

sday, December 22, 2011 10:03 AM

- mi 

Cc: Probst, Paul E. Howard, William (Bill) Lasky, Robert D. 
(cocroenpnrosar)

Subject: Vivarium air?ow tests

  

All,

 

I met with "3?33 - - - from DSAT earlier this morning to clarify points of observation during the Dec. 20
testing of airflows in the building vivarium. A floor plan indicating where airflow was monitored and the
directional airflow observed was given to after our meeting. .

The plan shows testing was performed at ante room entrances, procedure room entrances, and animal holding
area exits. Also, autoclave area and shower room entrances.

Hope this helps to better inform everyone.

Happy Holidays,

Dwayne Lasky

Safety and Occupational Health Manager
Office of Safety, Health and Environment
Centers for Disease Control and Prevention
404-639-4978

63?3-614-3?253

2
Accession Number: Specia191714 Page: 939 Sean Date: 2014-09-17 COPY

  

 (CDCIOPHPRIDSAT)

 

 

  

 

 

 

 

 

 

 

 

 

 

 

 

From:   WW 

Sent: Thursday, December 22, 2011 1:45 PM

To, [bil?iz I mime: mil-53 33:?  
lite-?Em '33  - - 

Cc: Probst, Paul E. William {Bill} (CDCIOCOOIOSHEI Bowen. Ken
L. Ilbll?l libil?? 
(CDCIOPHPRIDSATE 
(CDCIOPHPRIDSAT)

Subject: RE: Vivarium airflow tests

Thank you for your acknowledgement of completion of this request for DSAT, and a special thank you to all at the Roybal
Campus who worked to fulfill the request:

Warmest wishes for Happy Holidays!

 

[Edit-:42 U.S.C. 2?28[h}

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta, GA 30333

 

use. a 252arh;

 

 

 

 

 

 
 
  
 

(CDCIOPHPRIDSAT)

   

    

Sent: Thursda -- ember 22, 2011 10:17 AM
To: . (cocrocoorOSHE); 


- . (CDC/ocooreFO); Howard, William (Bill) (cocrocoorOSHE); Bowen, Ken L. (cocrocoorBFo -

Weyant, Rob 

-v 

Subject: RE: Vivarium airflow tests

    

ijbj:[I3}

 

 

 

The HVAC verification of the select agent registered space at your facility has been successfully completed.

I would like to express my very sincere thanks to everyone involved in the extensive work needed to perform and
document these tests. Thank you all very much, and I hope that everyone has a Merry Christmas.

 

 

 

1
Accession Number: Special91714 Page: 940 Sean Date: 2014-09?17 COPY

Yours truly,

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS 

Atlanta. GA 30333

 

ibii?B}

 

 

 

DSAT's vision: to be the preeminent resource for the safety and secority of biological agents and toxins.

This document is intended for the exclusive use of the recipientlsi named above It may contain sensitive information that is protectedpriviledged, or confidential.
and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientisi. be aware
that any disclosure, copying, distribution or use of the contents of this dDCument is strictly prohibited. Ifyou think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

 

 

From: rm? {cociocooiosna

Sent: Thur I I cember 22, 2011 10:03 AM

To:  

Cc: Probst Paul E. Howard, William (Bill) (cociocooiosuis); Lasky. Robert D. (cociocooi05HE);
(cocioPHPRiosnT)

Subject: air?ow tests

   
  

All,

I met with from DSAT earlier this morning to clarify points of observation during the Dec. 20
testing of airflows in the building vivarium. A floor plan indicating where airflow was monitored and the
directional airflow observed was given to after our meeting.

The plan shows testing was performed at ante room entrances, procedure room entrances. and animal holding
area exits. Also, autoclave area and shower room entrances.

Hope this helps to better inform everyone.

Happy Holidays.

 

(bits?-

 

 

 

Offioe of Safety. Health and Environment
Centers. for Diet: ase Control and Prevention

 

[bii?l

 

 

 

2
Accession Number: Specia191714 Page: 941 Sean Date: 2014?09?17 COPY

 

From: I?bil?i - 13"? 
Sent:  Ejfj?bm' 22, 2011 10:53 AM
To: 03:03.? 
Subject: ic en ers inspection?

- - we?re all set for HVAC on the new space. When I was talking withtodav, he confirmed for me that
the prior exhaust fan failure test included the entire Vivarium.

 

 

 

 



From:  inn-c;- 
Sent: urs a ecem er 22, 2011 10:48 AM
To: -  
Subject: RE: Which Centers inspection?

 

Congratulations!
October 12, 2010

I'll close out the renewal inspection today.

 

Can you also note that HVAC power failure is complete for the suite? As far as the exhaust fan failure, I've
asked to confirm that this vivarium included ?10342030- suite. asked ?1393342 at the inspection, and
I .a request in the inspection report that this be confirmed. suite inspection is 131312011. Was

mils? .able to confirm this item this morning? (The open Centers inspection in the annual verification
12:12:2011)

  

 

 

 

 

 

From: lbs: ?this? 
Sent: Thursda December 22, 2011 AM
To: . (CDCIOPHPRIDSAT)
Subject: Which Centers inspection?

  

- - do you know which Centers inspection it is that had the HVAC verification citation? I?d like to pull the right
inspection folder to say that we've gotten sufficient documentation.

 

. 1
Accession Number: Specia191714 Page: 942 Sean Date: 2014-09?17 COPY

    
 

       
 
 

 

 

 

 

 

 

 

 

 

 

From: -- - - - ..

Sent: Thursda December 22, 2011 9:28 

To: ?3?53 l'hi'?'l - 

Cc: ,lb3"33?42 HCDCIOSELSILS ??37 i?
mil?? ?ii 

Subject: FW: ?3313?: airflow test

Please see report below provided from OSHE this morning regarding the Vivarium Airflow Test conducted on December

19, 2011.

 

 

 

[b3l33142 U.S.C. 252301]

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta, GA 30333

 

?3:13)

 

:42 use. a 252mb;

 

 

 

 

 

From: this? Hm} I 
Sent: Thursday, December 22, 2011 8:45 AM

 

 

 

 

 

To: {$23,543  Howard, William (Bill) Probst, Paul E. (CDCIOCOOIBFO)
CC: r: (CDCIOCOOIOSHE)

Subject: .Mir?ow test

All.

A simulated power failure test of building was conducted 19 Dec. to observe airflows in the vivarium on level

Observers were stationed at the outer (clean) corridors and the inner ?aircrew-30-mm:

Electrical

 

disconnects for all supply and exhaust fans were de-energized simultaneously. All doors maintained

negative or static airflows.
All fans remained off for a period of approximater 10 seconds. After restart all doors remained or returned to
negative airflow.

 



 

 

 

Accession Number:

1

Specia1917l4 Page: 943 Sean Date: 2014-09-17 COPY

 

 

 

 

 

 

 

From:  

Sent: ber 01, 2011 ?:56 AM

To: are: (CDCIOPHPRIDSAT)

Co: mi? (C CIOPHPRIDSAT Zambuto Laura R. 
[bl-i314? miss Howard, William

 

 
 

 

{Bill} (CDCIOCOOIOSHE)
Subject: RE: new amendment to add ?13334

I'll look forward to talking with you this morning to discuss potential dates for the inspection of the 3 
- registered to the Division.

 

rooms for

 

suite to be

The Vivarium will be cold in December due to annual maintenance shut-down, so no immunization will
be necessary.

Also, we?ll be sure that the power failure testing scheduled for December now includes thesuite as well, and I?ll
clarify whether the previously submitted response for the exhaust fan failure test included all rooms in the 
Vivarium, or only.r the currently registered locations.

Best regards,

Ilbh23ii42 I ih3r3::42 u_s_o_?252aihj:
ll Ci 9
Centers for Disease Control and Prevention

Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

 

use. 252aihj:

 

 

 

 

From: I mil-51 

Sent: Wednesday, November 30, 2011 3:4? PM

 ?3333242  

Cc: osan

Subject: new amendment to add in?? rooms for

  

 

 

 

    

I wanted to make an earl inquiry as to scheduling an inspection for the i 3- 3 rooms to be added for PI  
et al. Also, will the vaccine be required for entry into the vivarium, or is this a possibility
depending on the work being performed at the time of inspection?

1
Accession Number: Specia191714 Page: 944 Sean Date: 2014-09?17 COPY

     

We will need'HVAC failure testing for these new ?33133342 rooms [TEiPEpmm ?1393*? - 

Ias well. I talked to   ??3?353  about the results she has received for the 
vivarium. For the exhaust fan failure results. it was noted that "all labs maintain required directional airflow".
Could you check with facilities to ask if "all labs" refers to all currently registered labs within vivarium.
or all labs present in the Bid vivarium (inclusive of the rooms to be added in this amendment)? If the
results do not include Suite ii . . . we will need to see fan failure testing for this suite before the amendment
results do include Suite. please provide a letter stating this. Also. please ensure

is included in the power failure testing scheduled for December.

 

 

   
   

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

Atlanta. GA 30333

?1133242 U30. 262Elt'h}

 

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vedors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. Ifyou are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. lfyou think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

- 2
Accession Number: Specia191714 Page: 945 Scan Date: 2014-09-17 COPY

 (CDCIOPHPRIDSAT)

    
   

 

 

 

 

 

 

From: 

Sent: 1 w. 1 mber 30, 2011 12:10 PM
To: 
Subject: RE: enters ailuretesting, vivarium
Thank you!

From: ?31153 

Sent: Wednesday, November 30, 2011 12:06 PM


E: Centers failure testing, vivarium

 

 

1:0}l3li42

room for Centers in has been scanned into NEAR. It is Ell-382;?

 

 

 

 

 

 

 

From: libel-  

Sent: Tuesda November 29, 2011 1:05 PM

To: . (CDCIOPHPRIDSAT)

Subject: RE: Centers failure testing, vivarium

 

0K, ifvou?ll please let me know the amendment number once you get it backlist.

 

 

 

 

 

 

From: 
Sent: Tuesda November 29, 2011 12:59 PM
To: 

 

Subject: RE: Centers failure testing, vivarium

 

I will ask ?33314 to inquire if the exhaust fan failure inciuded the new room, and if the new room will be included in the
power failure test to be performed. I was thinking they might have iooked at airflow at the containment boundaries for the
vivarium suite rather than at individual rooms.

The amendment was sent by FAX and oiassified yesterday. I won't have a copy until it is scanned or in my mailbox.

 

 

(CDCIOPHPRIDSAT)

mber 29, 2011 12:52 PM

(CDCIOPHPRIDSAT)

ers failure testing, vivarium

  
  

 

1
Accession Number: Specia191714 Page: 946 Sean Date: 2014-09?17 COPY

The 12f2010 exhaust fan failure test results for the Vivarium after the renovation was documented simply as
"Bldg for the location, and it was stated in the email from as being for theE?vivarium. After
each fan failure test. they recorded "all labs maintain required directional airflow?. Their power failure test is supposed

to be getting done in December. I guess we could ask them to affirm whether the previously performed tests include
results for the rooms being added. They also provided me with 10/2011 exhaust fan failure airflow observations for 33$?
suite and tests of the door gaskets for labsuite. 2523'?

    

 

 

 

 

Do you have an amendment vet. for the new space?

 

 

 

 

From: 
Sent: Tuesda . November 29, 2011 11:4? AM
To: 

Subject: Centers failure testing. vivarium

 

 

[biliE]

When Centers submitted data for HVAC failure testing for the vivarium. was it for the specific rooms on the
registration or for the vivarium as a whole? They will be adding an additional animal holding room and anteroom. and I'm
not sure if I'll need to ask for additional HVAC failure testing for this new room.

 

 

 

iblt?'}

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

illi 1 Al. 

(one:

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediater and destroy the original.

Please consider the environment before printing this e-mail.

2
Accession Number: Specia191714 Page: 947 Sean Date: 2014-09-17 COPY

   

 

 
 
  
 
 
 

 

 

 

 

 

 

 

From: i: . 
Sent: Fridav 2011 5159 AM
To; [his  [bi
cc;  2 
gash~ 
Subject: FWI  Vivarium u?Eigs??ggai
S95

 

 

 

 

ARO

 

 

From: Probst, Paul E. 
Sent: Wednesday, October 12, 2011 3:36 PM
To: Meechan. Paul J. (CDCJOCOOIOSHE WW I  . 
Cc: Bowen, Ken L. -  ?"4930 - J-  - - I .-
I bert D. Howard, William (Bill) (CDCIOCOOIOSHE)
use?. "262a Suite DSAT Test - 10f6f2011

       
     
   

     

.
Vivarium.

 

 

I I
Regarding Vivarium:

Test 1 - Fan Fail Test info is av 
This is a redundant fan pair set

r-nr 

nemesis - CDC
Bldg--

st December ?Air Flow Reversal Project". See attached Items #1 and 3.
. Please advise if more info necessary or this will suffice.

 

 

Test 2 - Power Fail- We will do a total power fail test when we are shutdown in December this year.

Test 3 - Return to Normal Power NA is closed transition)

Paul Probst, PE
Asst. Director

Facilities Maintenance and Engineering Office
Buildings and Facilities Office

Office: 404-639-0505

1
Accession NUmber: Specia191714 Page: 949 Sean Date: 2014?09?17 COPY

 air analysis of atlanta, inc.

1520 pine log rd
conyers,ga 30011
(No) 929-3165
(ND) 4834365 tax

December 28, 2010

Karen M055, PE

CDC Building Lab Renovation

Cx Functional Test Documentation
hm - Atlanta. GA

consulting
test and balance
commissioning

Re: CDC HVAC Mod Ox Functional Tests Documentation:

1. Fail by throwing disconnect on roof. Eerctod results: Exhaust plenum two

position damper closes and exhaust plenum static control damper modulates to
min in static pressure set point for the exhaust system Ayes _no.
?3333342 maintains pro-failure operating conditions 3 yes _no. All tabs maintain
required directional air?ow a yes _no.

 
 
 

 

2. Restoreinto operation and allow system to stabilize,

3. Fail by throwing disconnect on roof. Exgected results; Exhaust plenum two

position damper closes and exhaust plenum static control damper modulates to

static pressure set point  w.c. for the exhaust system yes _no.

. . . - aintains pro-failure operating conditions yes _no. All labs maintain
required directional airflow 35 yes _no.

4. Fail one fan A on dad.  Expected results: The remainingEE] supply fan
continues to operate and the VFD speeds up and maintains supply duct static
pressure set point for the supply air system? yes _no. Both    
continue to operate normally 3 yes _no. All labs maintain required directional
airflow z; yes.l_no.

   
 

  

     

5. Restore to normal operation and allow system to stabilize.

  

I.

6. Fail one fan on U35 Expected results: The remainingsupply fan
continues to operate and the VFD speeds up and maintains supply duct static
pressure set point Ewe. for the supply air system yes _no. Both
continue to operate normally 5 yes _no. All labs maintain required directional
air?ow 1 yes no.

 

7. Restore the system to normal operation.

3. Fail by throwing disconnects on roof. Exgected results: Exhaust
plenum position - - n, - as and exhaust plenum static control damper
closes. i yes _no. - shuts down both supply air fans and related
isolation dampers? yes _no. All labs required directional airflow is not
maintained. a yes _no.

   

 

Accession Number: Speoia191714 Page: 950 Sean Date: 2014?09?17 COPY

9. Restore the system to normal operation.

1ll Fail fans  3mm Expected to operate &shuts
down. Both exhaust fan plenum dampers open 100%. 3 yes__ no. Lab suite maintains
negative pressure to surrounding areas. Eyes _no. All lab directional air ?ow is not
maintained _yes 131]) no. 

   

11. Kill power to all four fans simultaneoust was suggested. Expected results: Lab suite
directional airflow is not maintained yes "no Air flow patterns in the suite are
directional to  the cage wash area 25 yes _no.

Notes:

(1) Total containment is maintained and all directional airflow is into the labs.

 

Accession NUmber: Specia191714 Page: 951 Scan Date: 2014-09?17 COPY

 (CDCIOPHPRIDSAT)

 
 
  
 
 

 

   
 

 

 

 

 

     

 

 

From: . 

Sent: 2011 6:51 AM

To: I CDCIOPHPRIDSAT)

Cc:   -
- 

Subject: - - 

Attachments: 2?56__001 .pdf

    

eted door PMs for the building 



[b36142 USE. 252mb}

 

.. 252 uite, 

 

 

 





From: Probst, Paul E. 
Sent: Wednesday, October 12, 2011 3:33 PM
To: i' . 
Subject: FW: Wm?? II Hoors test results

       

o. 

FYI
Thank;
Paul Probst

Message-nu
From: Bowen, Ken L. 

Sent: Tuesday, October 11, 2011 2:55 PM
To: -
Cc: icocmPi-ipajosm); Bowen, Ken L. {coc/ocoorBFol;
Probst, Paul E. 
Subject: [built-t2 usc. 2e2aih:

 

 

 

 

  
 

doors test results

 

The third door tested is outside the select agent area. The two doors that you described are two of the three doors he
tested. We have put an annual PM to perform the leak test for these two doors. The next PM will come out October
2012. Attached are the 2 annual PMs. Hope this takes this lab off the list of labs that need to be tested.

Thanks

Ken Bowen

Director for Facilities Engineering Office
4051-6396303 Office

404-639-0499 Fax



From: 

Sent: Thursday, October 06, 2011 3:40 PM

To: Bowen, Ken L. 

Cc: eel-=42 we: I 

Subject: Idoors test results

 

1
Accession Number: Specia1917l4 Page: 952 Sean Date: 2014-09-17 COPY

  

my no ?338,42 '1dicated two sealed doors for th - suite. One sealed door, according to my notes, is the one
from room use. 5"252ai which leads directly out to the non-containment corridor, and the other sealed door is the one
between the containment side of the shower and open area use 5:523

 

 

 

If you could either send me in writing the specific locations of all three sealed doors, or we could talk on the phone or in
person so that I can confirm on the floor plan that the envelope is sealed, then we should not need the failure test
results. However, if we go this route on confirming the secondary containment for the suite under failure conditions, 1
think the door leak test should be performed annually because of the way gaskets can degrade overtime. Do you think
that this annual door leak test is something that CDC would commit to performing, and could this be stated in writing?

Thank you,

 

Office

Message-uh

From: Bowen, Ken L. (cocrocooraroi

Sent: Thursday, October 06, 2011 3:20 PM

To:  i. :3 

Cc: Bowen, Ken L. (cocrocooraroi
Subject: FW: ~3 33 

  

 

 

 

Got one questions to ask, since thearea in Building now has all sealed doors and based on the maintenance
on the doors listed below, can this suffice for the fan failure test and the power outage test for this one select agent lab?
The thinking here is with the sealed doors in place it doesn't matter if the fan fails or the power fails, the doors are
sealed.

Thanks,

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax

?n-Original 

From: Branch, lyan (CTR)

Sent: Friday, September 30, 2011 11:10 AM

To: Bowen, Ken L. 

Cc: Probst, Paul E. Powell, Steven L. 

 

Subject: m. ?319134? U-S-C- 252W Idoors test results

 

 

2 .
Accession Number: Specia191714 Page: 953 Sean Date: 2014?09?17 COPY

Centers for Disease Control

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     

Buildings :e Work Task

Tani: No. Location lo: 2623??; Request: 

BIO: Eat. Start: _10i'00i?2012

Campos: Atlanta~Roybel Est. Hours: 24.00
Request Type Reyna: Building Est. Cost:
Preventive Floor: ib;i3;:42 U.S.C. 2523 Eat. End: 10107i?2012
Teal: Priority Room Dale: [m
Normal Requester: PM SCHEDULER Completed:
Printed Date Phone: Home: 0.00
10H 1:201 ?l Requested For: Of?ce:
Phone:

Request Class: Phil-Yearly Task Code: PM00091 Group Tag:
Action Request: Plil00691 Liquid Leek Test on 
Comment:
Responslile Unit Craft 
Home Description Branohiot?oe Branch Code Supervisor
Roybal Fooliliies Engineering Shop FED FEDS liven Branch
Responsible Technician
Name User ID
Teal: Procedure
FREEYEARLY  . . 
L'iqiid Leak Test  . Doors in

Liquid Leek Test  Doors in I 
containment side of the shower and open area 0 

  

  

. .. . .. Roybal Campus in suite. This door 'relocated between the

 

 

 

 

Actual Start: Taa?lt Status: Planned Labor: $0.00
Duration: 0 User ID: Other:
Acme! End: Ref til: Parts: $0.00
Hours: 0.00 Total: $0.00
Signature: Approved By:
Tech Report: Inspected By:
Accession Nomber: Specia191714 Page: 954 Scan Date: 2014?09?17 COP

 

 

 



Centers for Disease Control

Buildings and Facilities Office Work Task

 

 

 

 

 

 

 

 

Task No. Location ID: ?3133342 U-S-C- 5 2523'? Request: 10fti$i2012
CID: Est. Start: 1DIDBIZD12
Campus: Altama-Roybal Est. Hours: 24.00
Request Type Building: Roybal Building Est. Cost:
Preventive Fm: 0.3.0. 2623 531- EM: 101079012
Task Priority Room Data: 
Nomal Requester: PM SCHEDULER Completed:
Printed Date Phone: Hours: 0.00
1 0i11i2011 Requested For: Office:
Phone:
Request Class: PM-Yeany Task Code: PM00002 Group Tag:

 

 

3 (Did 
PMUDEQZ - Liquid Leak Test ours in [b13242 Lab.

Action Request:

 

Comment:

 

Responsible Unit Craft

 

Name Description Branchf?f?ce Branch Code superweor

 

Roybal dg Facilities Engineering snap FEO recs Ivan Branch

 

 

 

 

 

 

Responsible Technician

 

Name User lD

 

 

 

 

 

Test: Procedure

 

 
 
  

FREQ: YEARLY .
Liquid Leak Test . . 

Uqufd Leak Test 0338:1142 2023(th

  
   
   

    
 

2
33 tab

  
 
 

 

33[

 

Lab- - -
for Bldg. Roybal Campus in U. . 2'32 widd'u exits out to the non-?containment corridor.

 

 

 

 

Achral Start: Task Status: Ptanned Labor: $0.00
Duration: 0 User iD: Other:
Actual End: Ref ti: Parts: $0.00
Hours: 0:00 Account: Total: $0.00
Signature: Approved By:
Tech Report: Inspected Ely:

 

 

Accession Number: Specia191714 Page: 955 Scan Date: 2014-09-17

 

co;i

 

   

 

 

 

 

 

 

 

 

 

 

From: writ-?USO 3' 3?3 .. 

Sent: Friday 2011 6:46 AM 

To: (?3?53 SO than; CDCIOPHPRIDSAT)

Cc: M31342 PO): 
?3313?? 

Subject: FW: 5523.53: Suite DSAT Test - 10i6i2011

Attached are the airflow test results for the building  use.

 
  

 

 

From: Paul E. (CDCIOCOOIBFO)

Sent: Wednesday, October 12, 2011 3:28 PM W942 .

To: Meechan, Paul J. (CDCIOCOOIOSHE '3b1i33=142[ 
Cc: Bowen. Ken L. ii?i? 5262mm; 'i  

- Lasky, Robert D. Howard, William (Bill) (ceioccoiesnei
Subject: Suite DSAT Test - teieizen

 

 

  



      

.
Testing 

 

Please find attached results of testing conducted last week.

Paul Prebst, PE
Asst. Director

Facilities Maintenance and Engineering Office
Buildings and Facilities Of?ce

Office: 404-639-0505

1

Accession Number: Specia191714 Page: 956 Sean Date: 2014-09?17 COPY

Suite

     

Ro bal Buildin 

Select Agent Labs HVAC tests

October 12, 2011

Members from BFO, OSHE, and OSELS participated in HVAC testing of the

Suite registered tol [use

 

 There are five associated rooms in the suite:

 

 

[0:13:42 U.S.C. 252301}

. Tests began around 05:00 am on Oct. 6.

 

 

Description of Systems:

1.

Building is divided into three areas: Office Tower, Lab Tower, and High

U.S.C. 2523111}

 

Containment. is located within the lab tower portion of
Building '3 SE. The Office Tower and Lab Tower areas are both eleven stories
high.

Each floor of the Lab Tower is independently exhausted by a single exhaust
fan (no redundancy). A total of eleven exhaust fans serve the lab tower.
Each fan is controlled via Hand-Off-Auto starter. Normal operating mode is
in Auto mode and is operated to maintain static pressure with bypass
damper modulation.

 

. Each floor of the Lab Tower is independently supplied air by a single air

handling unit (no redundancy) dedicated that floor. The air handling unit
(AHU) is controlled by a variable speed drive subject to maintaining duct
static pressure. The AHU is interlocked with the exhaust fan such that upon
exhaust fan failure, the AHU shall stop.

Each floor of the Lab Tower has a Linear Equipment Room (LER). Each LER is
served by two relatively small, recirculating air AHU's.

. The Office Tower is served by one large AHU to supply air to all eleven

floors. This unit provides make-up air to maintain the south portion of the
Lab Tower negative.

Prescribed Testing Procedures



Accession Number:

 

[0023:2242 U.S.C. 262301}

Test #1 was turned off and allowed to come to
complete stop (static condition). Approximater 5:10 am.

Specia191714 Page: 957 Sean Date: 2014-09?17 COPY

2. Test #2 - simultaneous power failure of supply and exhaust fan
components consisting of the following equipment:  
I Each piece
of equipment was simultaneous de?energized at approximately 5:35 am.
Each piece of equipment was re-energized ten seconds later to simulate
backup power restoration. At approximater 5:41 am, all equipment was
back in normal operating mode and speed.

 

3. Test #3 return from using backup power to "normal power?. This test is
not applicable as Building utilizes "closed transition" upon return to
"normal power?.

Test Results observed bv OSHE

Observers were stationed at the entrance to each of the following locations:

 

 

 

 

 

 

(outer corridor door) procedure room door)
(outer ante room door) a Ifreezer room door)
USIC. 2o23
252athj: 
(inner ante room door) procedure room door)
l(procedure room door) [procedure room door)

 

All locations were smoked prior to testing and observed to have proper
directional airflow, moving from the outer corridor toward the inner procedure
rooms.

 

[bli3li42 U.S.C.

1. Test 1 a Fan (?ass-ace ailure Test - Room 262%: (freezer storage) was
positive. All other locations remained negative during the test.

2. Test 2 - Power Failure Test - All locations remained negative during the
failure and restart.

 

 

 

 

Accession NUmber: Specia191714 Page: 958 Scan Date: 2014?09?17 COPY

(CDCIOPHPRIDSAT)

 

 

From: Bowen, Ken L. (CDCIOCOOIBFD)
Sent: Tuesda October 11, 2011 2:55 PM
To: (?3?53 

     

 

 

 

 

 

 

 

cc: Elsie .2- Bowen,
Ken L. Probst, Paul I 

Subject: RE: I?ll-T33?42 I Idoors test results

Attachments: 

The third door tested is outside the select agent area. The two doors that you described are two of the three doors he
tested. We have put an annual PM to perform the leak test for these two doors. The next PM will come out October
2012. Attached are the 2 annual PMs. Hope this takes this lab off the list of labs that need to be tested.

Thanks

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax

Message-w"

From: this? 

Sent: Thursday, October 06, 2011 3:40 PM

To: Bowen, Ken L. (coqocooxesm

Cc: I 
Subject: RE: [9339342 - II Idoors test results

 

 





 

 

  

my nc I dicated two sealed doors for the U35 252 suite. One sealed door, according to my notes, is the one
from room which leads out to the non-containment corridor, and the other sealed door is the one
lb13t42

between the containment side ofthe shower and open area use ?252

 

 

 

 

If you could either send me in writing the specific locations of all three sealed doors, or we could talk on the phone or in
person so that I can confirm on the floor plan that the envelope is sealed, then we should not need the failure test
results. However, if we go this route on confirming the secondary containment for the suite under failure conditions, I
think the door leak test should be performed annually because of the way gaskets can degrade overtime. Do you think
that this annual door leak test is something that CDC would commit to performing, and could this be stated in writing?

Thank you,

[blt?l

 

 

 

 



From: Bowen, Ken L. 

Sent: Thursday, October 06, 2011 3:20 PM



Co more Bowen, Ken L. {cotfocoomFol

I I lie;:t3::42 
Subject: FW: doors test results

      

 

 

 

1
Accession Number: Special91714 Page: 959 Sean Date: 2014-09?17 COPY

Got one questions to ask, since the area in Building now has all sealed doors and based on the maintenance
on the doors listed below, can this suffice for the fan failure test and the power outage test for this one select agent lab?
The thinking here is with the sealed doors in place it doesn't matter if the fan fails or the power fails, the doors are
sealed.

Thanka

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Of?ce

404-639-0499 Fax



From: Branch, Ivan (CTR)

Sent: Friday, September 30, 2011 11:10 AM

To: Bowen, Ken L. (CDCIOCOOIBFCH

Cc: Probst, Paul E. CDC OCOO BFO Powell, Steven L. 
Subject; [b33142 use. a 252a[h; oars test r55u t5

   
  

 
 

0n 9f26f2011, we conducted several liquid leak test on all three of the 01:62:42 oors in lab. we
found no leaks of any kind on or around the doors. All three - - - oors passed the leak test.

2
Accession Number: Specia191714 Page: 960 Sean Date: 2014+09-17 COPY

(CDCIOPHPRIDSAT)

 

 

 
   

 

 

 

 

 

 

From: Bowen, Ken L. (CDCIOCOOIBFO)

Sent: Thursday, October 06, 2011 3:20 PM

To: ?13153 3393153; 

Cc: ?3133142.   9? Bowen, Ken L. 
Subject: 2 test results

 

Got one questions to ask, since the area in Building now has all sealed doors and based on the maintenance
on the doors listed below, can this suffice for the fan failure test and the power outage test for this one select agent lab?
The thinking here is with the sealed doors in place it doesn't matter if the fan fails or the power fails, the doors are
sealed.

Thanks

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax



From: Branch, Ivan 

Sent: Friday, September 30, 2011 11:10 AM

To: Bowen, Ken L. 

Cc: Probst, Paul E. Powell, Steven L. 
Subject: I?m??42 ?oors test results

 

 

0n 9f263?2011, we conducted several liquid leak test on all three of the -  - - - doors in lab. We
found no leaks of any kind on or around the doors. All three high containment doors passed the leak test.

1
Accession Number: Specia191714 Page: 961 Sean Date: 2014-09-17 COPY

 LCDCIOPHPRIDSAT)

 

From: Isis? 

Sent: Thursca Se tember 29, 2011 9:44 AM

To: this: (CDCIOPHPRIDSAT)

Subject: RE: Resutts: HVAC Testing, Roybal Campus

lhaue a copy, and I?ll send it for accessioning along with the single page of information that was provided yesterday for

1mm. Thanks,

 

From:l we: 

Sent: Thursda September 29, 2011 9:38 AM
To: (CDCIOPHPRIDSAT)
Subject: FW: Results: HVAC Testing, Roybal Campus

 

I did not print and accession this information. Can I bring you a copy to accession with the additional information you
have, or do you already have a copy?

 

 

 

. 1' '13  

Sent: Wednesday, September 21, 2011 12:55 PM

To: - - 

Cc: Bowen, Ken L. MeechanHVAC Testing, Roybal Campus

     
 

 

Good Afternoon,
The Buildings and Facilities Office (BFO) has provided the attached report for the required HVAC system testing of our

registered BSL3 laboratories. Please see the attached results for testing of registered BSL3 locations in Building 
Additional results will be provided upon completion of testing. Testing is scheduled for this week [Building 15} and again

next week (Building -
?1 File: Airflow as

Respectfully submitted,

 


[Weaken


Center-throl and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop 
Atlanta, GA 30333

Telephone: 404?639-2?53

 

 

 

1
Accession Number: Specia191714 Page: 962 Sean Date: 2014?09?17 COPY

(CDCIOPHPRIDSAT)

From: Bowen, Ken L. (CDCIOCDDIBFO)

Sent: Wednesda September 23, 2011 12:45 PM
To: 
Subject: - PW: HVAC testing recap

 

It was a very productive meeting and thanks for meeting with us.

Thanks,

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax

 

 



Sent: lWednesday, September 23, 2011 12:40 PM

To: Bowen, Ken L. (CDCIOCDDIBFD att Ted D. Howard, William (Bill) Lasltv,
0111:4930. [033142  

Cc: Meechan, Paul J. 
Subject: FW: HVAC testing recap

 

 
 
     

 
 

Please see the e-mail recap below of our meeting this morning provided by - 3* 3 . There is a typo in the 3"d

paragraph (suite room numbers) for the information pertaining to Building

 

[um

Please also note the ?New Request" regarding 0* and tests.

Seep

 

 

 

Thank you to all for your assistance in meeting this requirement,

Sincerely,

 

[0:133:42 U.S.C. 252alh}

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

[bll3]242 U.S.C. 262aih]

 

 

 

1
Accession Number: Specia1917l4 Page: 963 Sean Date: 2014-09-17 COPY

 

 

From: lee: Ilse:  (cocr0PHPruo3AT}
ptember 23, 2011 11:43 AM


 
 

 

   

 



 

 

Thanks to you, USE-s and all the other gentlemen who took the time to meet with me today. Here is a recap of our
conversation:

 

 

 

First we discussed the current status on the HVAC testing for buildings nd am not aware that any of these
results have been provided to date to DSAT.

 

[Out of Scope]

 

 

 

 

  



For the lab in building U-S-C- 2'52 suite}, there were initial tests performed when the lab was first brought
online, and witnesses at that time observed that the HUAC system operated as required to maintain secondary
containment. The facility engineers intend to reconstruct the tests which were performed and to write up the
observations which were previously made, and that should be completed within a few weeks.

     

i 252 lab in building ite] is scheduled to be tested next Thursday 10m, and a report will be rovided
[If 

to DSAT the following week, providing the testing is successful. For the building vivarium suite use? ""2523 suite
and suite], the exhaust fan failure tests have been successfully completed. Power failure/restart testing for the
vivarium is planned to be performed in December during a maintenance shutdown.

 

 

[Cut of Scope]

 

 

 

2
Accession Number: Specia191714 Page: 964 Sean Date: 2014-09-17 COPY

 

My understanding is that your intent is to repeat the power failurefrestart test of the suite and th - Us}: 
suite within 3 weeks, after some HVAC modifications have been made, and that you will perform airflow observations
within the suites during that retesting.

New Reguest

One thing which i did not say during our meeting but wh' I am requesting now is that DSAT be provided with the
results of the power failurefrestart tests for the buildingspaces and the results of the exhaust fan failure tests for the
building vivarium spaces. Because it was said today that these tests were successful, I would appreciate getting the
results to whittle down the list of remaining items and to be able to demonstrate the total amount of progress made
toward completing this project. I am also requesting that an update be provided to DSAT, once available, on the Gomez
lab suite} results even if potential problems are noted, for the same reason.

Sum mag?:

     

It is my opinion that a significant effort is being made by registered entity CDC to comply with request to perform
HVAC verification of the registered areas. It is understood that performing these tests, making any
necessary HVAC modifications and then doing subsequent retesting can be very labor intensive and time consuming. I
told you that I thought that the December retesting projection for the building vivarium power failuref restart would
be accepted by DSAT because other registered entities have been encouraged to perform the tests during maintenance
shutdowns. The use of annual leave by testing personnel prior to the end of the year and the December holidays could
present problems, however, for meeting this projection. Please consider whether these factors reduce the likelihood of
this timeline being met, and provide either a confirmation or a revised estimate for the building vivarium retesting

date.

It is probable that the inspection will remain open until this testing has been successfully completed. Please let me know
if anything stated about the testing status in this email is inaccurate.

Yours truly,

was:


Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1500 Clifton Road, MS A-d?

Atlanta, GA 30333

 

 

 

 

 

[bizi?l

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisj named above. it may contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientis}, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictiy prohibited. If you think you have received this document in error. please
notify the sender immediater and destroy the original. Thank you.

3
Accession Nomber: Specia191714 Page: 965 Scan Date: 2014?09?17 COPY

 (cocroeHPRrosm)

 

 

From: . 
Sent: Wednesda September 28, 2011 12:36 PM
To:  
Subject: RE: HVAC testing recap

I note a typographical error in the third paragraph for The suite should be inclusive of as opposed
Otherwise, this looks good to me.

  

Thank you, again, for your time this morning.

Best regards,

U.b.Lr. I

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop Fit-22

Atlanta, GA 30333

 

 

[b13142 U.S.C. 262mm

 

 

 

 

From: 
Sent: Wednesda September 28, 2011 11:48 AM

 -   
Weyant, Rob  

      

. 

 

Thanks to will;I 
conversation:

. nd all the other gentlemen who took the time to meet with me today. Here is a recap of our

 

First we discussed the current status on the HVAC testing for buildingsand i am not aware that any of these
re5u ts have been provided to date to DSAT.

 

[Out of Scope]

 

 

 

1
Accession Number: Special91714 Page: 966 Sean Date: 2014-09?17 COPY

Buildin

   

For the ab in building suite], there were initial tests performed when the lab was first brought
online, and witnesses at that time observed that the HVAC system operated as required to maintain secondary
containment. The facility engineers intend to reconstruct the tests which were performed and to write up the
observations which were previously made, and that should be completed within a few weeks.

The Gomez lab in building suite) is scheduled to be tested next Thursday 10,16, and a report will be rovided
to DSAT the following week, providing the testing is successful. .For the building vivarium suite suite
an Us}; 252 suite), the exhaust fan failure tests have been successfully completed. Power failurer?restart testing for the
vivarium is planned to be performed in December during a maintenance shutdown.

 

[Out of Scope]

 

 

 

New Request

One thing which I did not say during our meeting but which I am requesting now is that DSAT be provided with the
results of the power failure/restart tests for the building spaces and the results of the exhaust fan failure tests for the
building vivarium spaces. Because it was said today that these tests were successful, I would appreciate getting the
results to whittle down the list of remaining items and to be able to demonstrate the total amount of progress made
mpleting this project. I am also requesting that an update be provided to DSAT, once available, on the Gomez

 

[If 

lab use. 252;. suite] results even if potential problems are noted, for the same reason.

Summary

It is my opinion that a significant effort is being made by registered entity CDC to comply with DSAT's request to perform
 HVAC verification of the registered areas. It is understood that performing these tests, making any
necessary HVAC modifications and then doing subsequent retesting can be very labor intensive and time consuming. I
told you that I thought that the December retesting projection for the building viva rium power failurefrestart would
be accepted by DSAT because other registered entities have been encouraged to perform the tests during maintenance
shutdowns. The use of annual leave by testing personnel prior to the end of the year and the December holidays could

  

2
Accession Number: Specia191714 Page: 967 Sean Date: 2014?09?17 COPY

present problems, however, for meeting this projection. Please consider whether these factors reduce the likelihood of
this timeline being met, and provide either a confirmation or a revised estimate for the building vivarium retesting
date.

It is probable that the inspection will remain open until this testing has been successfully completed. Please let me know
if anything stated about the testing status in this email is inaccurate.

Yours truly,

 

[bli?j

 

 

 

l' 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS 

Atlanta, GA 30333

 

[bjzi?jz

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientis] named above. It mav contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If vou are not the intended recipientls}. be aware
that ant.I disclosure, copying, distribution or use of the contents of this document is strictlv prohibited. if you think you have received this document in error, please
notihI the sender irnmediatelvI and destrov the original. Thank vou.

3
Accession Number: Specia191714 Page: 968 Sean Date: 2014?09?17 COPY



 

 

 
     

From: left? 

Sent: Thurscay, September 08. 2011 8:1 --

To: Weyant, Rob (CDCIOPHPRIDSAT - (CDCIOPHPRIDSAT -
{copioPHeerosm}; I 


Subject: RE: Checking in

   

. . . . . 
have reviewed the AJC article on the is: ab and the duct taped door, and It states that the lab lost Its negative air

pressure after an HVAC restart. toid Ken that the previous test results would be fine if they include both exhaust fan
failure and power failurefrestart. We always have the option of asking questions about the results which are provided.

 

From: Weyant, Rob 

Sent: Thursday, September 08, 2011 ??22 AM

To:  3 (cocyoenpaiosm); (use: (cocyOPHPwosar); 
the:  

Subject: RE: Checking in

 

   
     

  

 

 

 


Are you happy with the testing of thelab, as described below?

Let?s plan on getting alt parties together around the end of this month unless all testing has been done and reported to
us.

Thank;

Rob Weyant

 

 

From: lei-:5? 

Sent: Thursday, September 08, 2011 7:16 AM
To: weyant, Rob . 
mie? (cocrormpwosm);  
Subject: FW: Checking in

   

-  

  

 

Good morning,

Here is an update from Ken Bowen on HVAC testing plan.

[bit?l

 

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A?a?

Atlanta, GA 30333

1
Accession Number: Specia191714 Page: 975 Sean Date: 2014-09?17 COPY

 

ibif?l

 

 

 

DSATs vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientlsi named above. It may contain sensitive information that is protectedpriviiedged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. Ifyou are not the intended recipientts}, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error. please
notify the sender immediately and destroy the original. Thank you. -

 

From: Bowen, Ken L. (CDCIOCOOIBFO)

Sent: Thursday, September 08, 2011 6:33 AM

To: ere: (cocioriHPRiosm

cc: Meechan, Paul J. (cociocooiOSHE); 
Subject: RE: Checking in

   

Bowen, Ken L. 

What we have found for the power outage test in some cases it is simpler to just turn off the power to the whole building.
We have so many interlocks and safeties build into our new buildings it is harder to create a simulated outage than turn of
the entire building and deal with the issues that this procedure causes.

When we modified the HVAC system in to the redundant fans system, we tested this lab just like the criteria
mentioned in the Policy on BM BL 5"1 Edition Laboratory Facilities (Secondary Barriers] Standard that was given to us
during our last meeting. OSHE and our office both observed the air ?ow through a magnehelic gauge and certified that
the lab was working before we went hot. We will give a document that certifies this observation as record of this testing.
We will not retest this area just use our previous observations. Keep in mind the sealed doors were never part of the lab
functioning properly. Our test was performed with normal lab doors where the sealed doors are today and still had proper
directional air flow. These doors were added later as a result of an AJC article.

 

We will also be submitting data from the previous project to verify proper air flow for labs 
All other labs are scheduled to be tested on September 15, 22, and At the beginning of October we Will have a better
picture of where we are.

 

Thanks,

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax

 

 

From: Imi?mi ?this? 
Sent: Friday, September 02, 2011 8:36 AM
To: Bowen, Ken L. (CDCIOCOOIBFO)

Cc: Meechan, Paul J. (CDCIOCOOIOSHE)
Subject: Checking in

2
Accession Number: Specia191714 Page: 976 Sean Date: 2014?09?17 COPY

Dear Ken,

There is a little more information that I wanted to provide you on the HVAC verification testing and the
rooms to be tested:

For the power failurefrestart test, DSAT is not requiring that any entity actually shut off the normal power and perform
a load switch, because of the disruption this may mean for building occupants as well as the potential hazards to
electrical components during a load switch. Ifyou wish to perform the test as a load switch, that is an option, but the
power failurefpower restart tests could instead be done as a simulation by simultaneously shutting off both the supply
and the exhaust fanls) which serve the laboratory rooms, while monitoring and recording the room differential
pressures or airflow, and then simultaneously turning on the supply and exhaust fans, while monitoring and recording
room airflow or pressure.

     

After our meeting last week, I talked with 33- about Building suite (the one with the pressure-sealed
laboratory doors}, and she showed me which of the doors on the floor plan have been fitted with gaskets. The gasketted
door at the suite entrance to the main open containment space appears to have a series ofthree doors between it and
the containment boundary, making the possibilit of an airflow reversal outside of containment via this route very
unlikely. The other gasketted door in room us. "'2a2ar between a room and directly outside of containment. There
are two options for suite for confirming the facility design to prevent aidlol?l under failure conditions.
One option is to provide the result of a leak test, such as a soap bubble test, of the .gasketted door, confirming
that the door is air tight. The other option is the performance of the HVAC failure scenarios as discussed last Friday.

 

 

Please let me know when you will have any update on test results or a testing plan. If you have any final test results, you
could email them to me directly ifthat is convenient.

Thank you,

[bji??

 

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-46

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the named above. It may contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientls}, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

3
Accession Number: Specia191714 Page: 978 Sean Date: 2014-09?17 COPY

(CDCIOPHPRIDSAT)

 

 

 

From: libii?i 3 3' 3' (CDCIOPHPRIDSAT)
Sent: Thursc av, September 08, 2011 8:04 AM
To: Bowen. Ken L. (CDCIOCOOJBFO)
Subject: RE: Checking in

That?s great, Ken. So long as no subsequent major changes have been made to the HVAC system that serves an area,
previous test results will be fine if they cover both single exhaust fan failure and power failurefrestart and it is made
clear in the narrative which points on the floor plan were being monitored by witnesses.

 

From: Bowen, Ken L. (CDCIOCOOIBFO)

Sent: Thursda September 03, 2011 6:33 AM
To: 

Cc: Meechan, Paul J. (cocrocoorOSHE);
Subject: RE: Checking in

 

Bowen, Ken L. (CDCIOCOOIBFO)

What we have found for the power outage test in some cases it is simpler to just turn off the power to the whole building.
We have so many interlocks and safeties build into our new buildings it is harder to create a simulated outage than turn of
the entire building and deal with the issues that this procedure causes.

When we modified the HVAC system ice the redundant fans system. we tested this lab just like the criteria
mentioned in the F'olicj,r on BMBL Edition Laboratory Facilities (Secondary Barriers) Standard that was given to us
during our last meeting. OSHE and our office both observed the air flow through a magnehelic gauge and certified that
the lab was working before we went hot. We will give a document that certifies this observation as record of this testing.
We will not retest this area just use our previous observations. Keep in mind the sealed doors were never part of the lab
functioning properly. Our test was performed with normal lab doors where the sealed doors are today and still had proper
directional air ?ow. These doors were added later as a result of an AJC article.

 

We will also be submitting data from the previous project to verify proper air flow for labs If it12133142 U-S-C- 2mm: 
All other labs are scheduled to be tested on September 15, 22, and At the beginning of October we will have a better
picture of where we are.

Thanks,

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404-639-0499 Fax

 

 

From: rims-?-  Iib3i53 
Sent: Friday, September 02, 2011 3:36 AM
To: Bowen, Ken L. (CDCIOCOOIBFO)

1
Accession NUmber: Specia191714 Page: 979 Sean Date: 2014-09?17 COPY

Cc: Meechan, Paul J. (CDCJOCOOKOSHE)
Subject: Checking in

Dear Ken,

 

There is a little more information that I wanted to provide you on the
rooms to be tested:

HVAC verification testing and the

For the powerfailurefrestart test, DSAT is not requiring that any entity actually shut off the normal power and perform
a load switch, because of the disruption this may mean for building occupants as well as the potential hazards to
electrical components during a load switch. If you wish to perform the test as a load switch, that is an option, but the
power failurer?power restart tests could instead be done as a simulation by simultaneously shutting off both the supply
and the exhaust fanis] which serve the laboratory rooms, while monitoring and recording the room differential
pressures or airflow, and then simultaneously turning on the supply and exhaust fans, while monitoring and recording
room airflow or pressure.

After our meeting last week, I talked with -  about Building suite (the one with the pressure-sealed
laboratory doors], and she showed me which of the doors on the floor plan have been fitted with gaskets. The gasketted
door at the suite entrance to the main open containment space appears to have a series of three doors between it and
the containment boundary, making the possibilit of an airflow reversal outside of containment via this route very
unlikely. The other gasketted door in roois between a room and directly outside of containment. There
are two options for suitefor confirming the facility design to prevent airflow reversal under failure conditions.
One option is to provide the result of a leak test, such as a soap bubble test, of thgasketted door, con?rming
that the door is air tight. The other option is the performance ofthe HVAC failure scenarios as discussed last Friday.

 

Please let me know when you will have any update on test results or a testing plan. If you have any final test results, you
could email them to me directly if that is convenient.

Thank you,

 

[may

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A45

Atlanta, GA 30333

[Dita]

 

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientis] named above. It may contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientisl, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error. please
notify the sender immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: 980 Sean Date: 2014-09-17 COPY

 

Center use? 2 Laboratories

Bldg?Re-om or Suite PI Group Comments

[0th of Scope]

 

 

[1131:3342 use. 252m:

 

 

 

[Out of Scope]

 

 

 

Acce?sion Number: Specia191714 Page: 985- Scan Date: 2014-09-17 COPY

 (c DCIOPHPFUDSAT)

 

From: Bowen, Ken L. 

Sent: Wednesda September 2011 AM
To:  

Cc: Bowen, Ken L. 
Subject: RE: Checking in

Can you send me the etectronic copy of the labs that need to be tested that your office gave out in our last meeting?

Thanks,

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404?639-0499 Fax

 

 

I (CDCIOPHPRIDSAT)
Sent: Friday, September 02, 2011 8:36 AM
To: Bowen, Ken L. (CDCIOCOOIBFO)

Cc: Meechan, Paul J. (CDCIOCOOIOSHE)
Subject: Checking in

 

DearKen,

There is a little more information that I wanted to provide you on the HVAC verification testing and the
rooms to be tested:

For the power failure/restart test, DSAT is not requiring that any entity actually shut off the normal power and perform
a load switch, because of the disruption this may mean for building occupants as well as the potential hazards to
electrical components during a load switch. If you wish to perform the test as a load switch, that is an option, but the
power failurefpower restart tests could instead be done as a simulation by simultaneously shutting off both the supply
and the exhaust fanis] which serve the laboratory rooms, while monitoring and recording the room differential
pressures or airflow, and then simultaneously turning on the supply and exhaust fans, while monitoring and recording
room airflow or pressure.

 

After our meeting last week, I talked with bout Building if. vie-"i suite [the one with the pressure-sealed
laboratory doors), and she showed me which of the doors on the floor plan have been fitted with gaskets. The gasketted
door at the suite entrance to the main open containment space'appears to have a series of three doors between it and
the containment boundary, making the possibility of an airflow reversal outside of containment via this route very
unlikely. The other gasketted door in room 5 between aroom and directly outside of containment. There
are two options for suite  252 for confirming the facility design to prevent airflow reversal under failure conditions.
One option is to provide the result of a leak test, such as a soap bubble test, ofthegasketted door, confirming

that the door is air tight. The other option is the performance of the HVAC failure scenarios as discussed last Friday.

 

 

1
AccesSion Number: Special91714 Page: 986 Sean Date: 2014-09?17 COPY

Please iet me know when you will have any update on test results or a testing plan. If you have any final test results, you
could email them to me directly if that is convenient.

Thank you,

 

[biij?i

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A46

Atlanta, GA 30333

{bits}

 

 

 

 

vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient-:5} named above. It may contain sensitive information that is protectedpriyiledged, or Confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. ll you are not the intended recipientisl, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: 987 Sean Date: 2014?09?17 COPY

 (CDCIOPHPRIDSAT)

      

From: 
Sent: - o. - 
To: 
Subject: RE: Centers HVAC failure testing

 

I think that you gave me a copy of all of the floor plans already, but I would like the Suite definitions, ?33342 if they are

different from what is in NSAR.

From:  ms:  
Sent: ues a ugus 0, 2011 9:59 AM
To: (CDCIOPHPRIDSAT)
Subject: RE: Centers HVAC failure testing

 

 

I spoke with - 33 3* yesterda . and she stated that BFO clearly knows which are the select agent registered areas. I had
indicated the wrong floor for $3342 space on the spreadsheet passed around on Friday, and BFD had contacted
to clarify. I was thinking you might like to have a copy of floor plans and suite definitions at your desk to help address
questions and review results provided. I think it would be better to hear from BFO that they want this information from us
before providing it.

 

 

 

 

From: 
Se t: Tuesday. August 30, 2011 9:4? AM
To: [bjzi?i (CDCIOPHPRIDSAT)
Subject: RE: Centers HVAC failure testing

(oils?-

From the email traffic between you and .
terms for registered spaces.

 

 

 

 

 

suite definitions may be very helpful in clarifying the NSAR database
It couldn?t hurt to provide a set of floor plans also, since they may be swamped with so many that finding the relevant
ones could be a challenge.

I have been thinking about sending an email with some follow-up information on the options for power failurefrestart
testing and the suite with the sealed doors. Maybe we could do this together as one emailed packet.

 

From: [bi-i6: 
Sent: Tuesday, August 30, 2011 9:28 AM
To: 
Subject: Centers HVAC failure testing

 

 

 

.
1

Accession Number: Specia191714 Page: 988 Sean Date: 2014-09?17 COPY

 

Would it be helpful for me to put together floor plans and suite definitions for the laboratories that need
HVAC failure testing?

 

iblt?l

 

 

 

 

[bili?l

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE M8 A46
mg as smart

(CHE: II



 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e?mail.

2
Accession NUmber: Specia191714 Page: 989 Sean Date: 2014?09?17 COPY

(CDCIOPHPRIDSAT)

 

 
  
 

 
   

 

From: 
Sent: .Tuesda-[mm12 0. 2011 9:47 AM

To:  sis-was 
Subject: RE: Centers HVAC failure testing

 

 

 

From the emait traffic between you and Ii'r- 1
terms for registered spaces.

suite definitions may be very helpful in clarifying the NEAR database
It couldn?t hurt to provide a set of fioor plans also. since they may be swamped with so many that finding the relevant
ones could be a challenge.

I have been thinking about sending an email with some followsup information on the options for power failurefrestart
testing and the suite with the sealed doors. Maybe we could do this together as one emailed packet.

 

 

 

From: mire: 
Sent: 2011 9:28 AM
To: 
Subject: Centers HVAC failure testing

 

 

Would it be helpful for me to put together floor plans and suite definitions for the 3 
HVAC failure testing?

ibit?)?

Division of Select Agents and Toxins

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

Atlanta GA 30333

[bildi

laboratories that need

 

 

 

 

 

 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public hearth in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. lfyou are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediater and destroy the original.

Please consider the environment before printing this e?mail.

1
Accession Number: Specia191714 Page: 990 Sean Date: 2014?09?17 COPY

 

{copioeneniosmi

 

 

 

 

 
  

From: W- (CDCIOPHPRIDSATJ
Sent: Friday, August 12, 2011 12:39 PM
To: Weyanl, Rob CDCIOPHPRIDSAT
cc: liens: I mire; (CDCJOD

  

 

 

 


Subject: Update on Centers 


verification

Dear Dr. Weyant,

 

- - and I met yesterday and again today to discuss the areas on the CDC registration for which DSAT
has yet to receive information on verification. We are checking our list multiple times to be sure that we?re
capturing all of the areas of interest for Buildingand We will both be ready to provide a briefing during the
week of August 22-26.

I have already suggested the morning of Monday, August 22 or Wednesday, August 24, to another registered entity for a
conference call. I will not try to schedule any other conference calls during the week of August 22-26 until I hear back
from you as to whether you think a meeting would take place with CDC personnel during that time period.

Here are some major points thatl land I have discussed:

 

?33,5:

 

 

 

  

ibii?}

Facility Specialist

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, M5 A416

Atlanta GA 30333

 

(bli?l

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientIsi named above. it may contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive Such information. If you are not the intended recipientls], be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this documEnt in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Specia191714 Page: 991 Sean Date: 2014-09?17 COPY

 

 

 

From: 
Sent: 'vlonda Au ust 151 2011 ?:02 AM
To: I one: I 
Subject: RE:

(006:: I

 

 

 

I think that it would be best for you to send your correspondence directhr to Dr. Weyant, because the decision on who to
include in this meeting is entirely up to him.

 

(CDCIOPHPRIDSAT)
Sent: Saturda August 13, 2011 12:51 PM
To: 
Subject: Fw:

 

 

 

 

 

 

 

 

 

 

 

 

- - .  
Sent: Frida Auust 12, 2011 05:56 PM
(CDCIOPHPRIDSAT)

 

 

From: (CDCIOPHPRIDSAT)
Sent: Frida Auust 12, 2011 03:32 PM


 

Subject:

 

DSAT contacted and Paui Meecham to inquire about setting up a meeting to discuss observation 36 from
the October 2010 inspection report concerning no reversal of air flow under failure conditions.

 

 

[bli?l

 

 

 

 

10:03::

 

1
Accession Number: Specia191714 Page: 992 Sean Date: 2014-09?17 COPY

Division of Select Agents and Toxins

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Lula-1h: CA 

 

USO. 252%:

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for lhe exclusive use or the recipient named above. It may contain sensitive information that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such infonhation. It you are not the intended recipient. any dissemination.
distribution, or copying is strictly prohibited. It you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-mail.

2
Accession NUmber: Specia191714 Page: 993 Scan Date: 2014?09?17 COPY

(CDCIOPHPRIDSAT)

 

From: 

Sent: Thursday Ma 08, 2008 10:30 AM

To: i lint-5': (CDCIOPHPRIDSAT)
Subject: Centers inspection report response

Deal.- ibii?l

 

have reviewed the May 5th Centers response to the 1t15f03 inspection report. and I think that the inspection may be
ready to be closed out. This response is not yet in the inspection folders right now at 10am}, but I've printed a working
copy that l'll leave in the back of inspection folder Here's a summary of the responses made:

1. The 3rd and 4th pages of the working copy have Center's stated answers to the questions sent in our 4i22i08 letter.
These sections are highlighted for your review.

2. Raw data sheets were re-sent to us with an unexpired [at the time of the testing) certification stamp.

3. The last 4 pages of the working copy are supposed to be trending data for pressure and airflow of labs. i don't know
how to interpret this data. Maybe Dwayne should look at it for us?

I'll be out on Friday but back in the office all next week.

 

Constella Group. LLC

Contractor of the CDC Division of Select Agents and Toxins
1600 Clifton Road

MS A-46
.etlaota?aca??aa?

[oii?i

 

 

 



1
Accession Number: Special91714 Page: 997 Sean Date: 2014-09?17 COPY

(bit?i 

 

 

 

 

 

 

 

 

Subject: FW: Biosafety compl i campus

Location: Dr. Weyant's Office - {Dita} 
Start: Thu 41?121'2012 11:00 AM

End: Thu #1212012 12:00 PM

Recurrence: {none}

Meeting Status: Accepted

Organizer: (CTR)

- inal A - 

(CTR)

Sent: Wednesda Acril 11, 2012 1:38 PM

To:  use (CTR - (blf?l 
I this: 

 

Cc: Weyant, Rob 
Subject: Biosafetii? complaint on the CDC campus
When: Thursday, April 12, 2012 11:00 PM Eastern Time (US Canada).

Where: Dr. Weyanfs Of?ce Passcode: 

 

 

 

 

 

 

 

From: Weyant, Rob 

Sent: Wed nesday, April 11, 2912 7:40 AM

To: {nits}
(bits: 



Subiect: Fw: Biosafety complaint on the CBC campus

Good morning folks.

Please see the below communications from Dr. Khan and other senior CDC leaders. We need to
initiate an investigation of this incident. In order to avoid the appearance of a conflict of interest, we
need to inform and involve our APHIS partners. l?ll be working from home this morning. but would like
to meet with you tomorrow to discuss.

Please set up a meeting for the folks on this message.

Many thanks,

1
Accession Number: Specia191714 Page: 998 Sean Date: 2014w09*17 COPY

Rob Weyant

From: Khan, Ali 8. (CDCIOPHPRIOD)

Sent: Tuesday, April 10. 2012 6:49 PM

To: Weyant. Rob (C DCIOPHPRIDSAT)

Co: Austin, A. Sosin, Dan (CDCIOPHPRIOD)
Subject: Biosafety complaint on the CDC campus

Exerini iike the recent complaint, please develop a thoughtful and measured plan.

Given that some may perceive that CDC is inspecting itself, if our response calls for an
inspectioniinvestigation after discussion with the R80. we should consider the team composition.

Thank you,

A

From: Henderson, Joseph (CDCIOCOOIOSEP)

Sent: Tuesday, April 10. 2012 6:21 PM

To: Arias, Ileana Berger. Sherri Seligman, James D. (CDCIOCOOJOD)
Co: Khan, Ali 8. Khabbaz, Rima Bell, Beth (CDCIOIDINCEZID)
Subject: Re: Complaint of Biosafety violations on the CDC campus

Ileana, Sherri. and Jim. manystatf the 3803 and from NCEZID were engaged in discussions

today rotated to the issue that raised pertaining to a perceived safety

issue in hamlet: in theE?Zlof We are working on a one-pager related to this event but
ibii?l

need program input which we will have in the morning. Nate Powell had a meeting with oday
and I wanted to hear how that went before we ?nalize our full assessment of this issue.

 

 

i?ll get this to you first thing in the morning.

Joe

From: Arias, lleana (CDCIOD)

Sent: Tuesday, April 10. 2012 02:54 PM

To: Henderson, Joseph (CDCIOCOOEOSEP)

Subject: RE: Complaint of Biosafety violations on the CDC campus

Thanks. Let me know what is going here and what if anything weaned to do.

2
Accession Number: Specia191714 Page: 999 Sean Date; 2014*09-17 COPY

 

From: Henderson, Joseph 

Sent: Tuesday. April 10, 2012 11:10 AM Eastern Standard Time

To: Berger, Sherri Seligman, James D. Khan, Ali 5.
Bell, Beth Khabbaz, Rima Chu. May
Arias, lleana {00000)

Cc: Meechan, Paul J. Chandler. George Henderson,
Joseph (CDCIOCOOIOSEP)

Subject: FW: Complaint of Biosafety violations on the CDC campus

All, I have asked Paul Meechan to setup a meeting today with OSHE, BFO, from
and me to get the facts on this complaint and assure we are all
completely clear on this issue before further actions are taken. I will be sure to provide an update
once we have the call and have the facts straight and actions clear.

Keep in mind I?m taking the helm on this issue in my new role providing oversight of the process to
consolidate OSEP. OSHE, BFO, Sustainability and Logistics Management from PGO. Just in case
you are curious as to why I initiated this emaii. If anyone wants to discuss please let me know.

Joseph M. Henderson -
Director, Of?ce of Security and Emergency Preparedness

Centers for Disease Control and Prevention 
U. S. Department of Health and Human Services


 

From: Khan, Ali 8. (CDCJOPHPRIOM

Sent: Tuesday, April 10. 2012 10:35 AM

To: Bell, Beth 

Cc: Arias, lleana Meechan. Paul J. Khabbaz, Rima 
Chu, May 

Subject: Complaint of Biosafety violations on the CDC campus

 

[bit5ttbit5i

 

 

 

3
Accession Number: Specia191714 Page: 1000 Sean Date: 2014?09-17 COPY

 

[blKELEblt?l

 

 

 

 

From: Weyant, Rob 

Sent: Tuesday, April 10, 2012 8:50 

To: Khan, Ali 8. mite} (CDCIOPHPRIOD) 
(CDCIOPHPRIOD) 
Subject: FW: Request for DSAT Training

 

 

 

 

 

Good morning folks,

F?fl. please see below I've asked my folks to tottow up and brief me on the incident. The tour was
supposed to be at a portion of the facility that was undergoing. maintenance and cold.

Rob Weyent

Robbin St Weyant, 

Captain, USPHS (Ret)

Director, Division of Seteot Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404-?18?2001

Cell phone: 6?8?614-?284

SiprNet'. isetz?g@iriggdiesmilmil

DSAT Vision: To be the preeminent resource for the safety and security of bioiogice! agents and
toxins.

4
Accession.Number: Specia1917l4 Page: 1001 Sean Date: 2014-09~17 COPY

This document is intended for the exclusive use of the recipient(s) named above. It may contain
sensitive information that is protected, priviieged, or con?dential, and it should not be disseminated.
distributed, or copied to persons not authorized to receive such information. If you are not the
intended recipient(s), anyr dissemination, distribution, or copying is strictly prohibited. If you think you
have received this document in error, please notify the sender immediately and destroy the original.
Thank you.

 

 

From one I (CDCIOPHPRIDSAT)

Se 11" I'ti'lnnH-hu Anvil 09'   

To ?it?s-i (CDCIOPHPRIDSAT): Weyant, Rob (CDCIOPHPRIDSAT)
Co [me ICDCIOPHPRIDSAT)

Su eject: FW: Request for DSAT Training

Dr Weyant and Dr

 

 

 

 

 

 

i thought this wedld be of your interest. have another email from Isaying how
pleased she was to help DSAT in future training sessions. I am not sure what exactiy happened since
that email

 

Front? (bits) (CDCIOIDINC-EZID)

Sent: Manda A 09, 2012 3:47 
Powet}, Nathaniel (CDCIOIDINCEZID)

o: Frieden. Thomas (Tom) (C tbif?} 
-

 

 

 

 

 

 

 

 

 

 a I use. 262alh}
U-S-C- 25230? (CDCIOCOOIOSH E)
Subject: RE: Reques or raining

 

th?le?}

 

 

 

5
Accession member: Specia1917l4 Page: 1002 Sean Date: 2014-09~17 COPY

 



 

 

 

 

 

 

Froml we 
Sent: Monday, April 09, 2012 10:49 AM

To: Powell, Nathaniel 
Cc:  we mm 
Subject: Request for DSAT Training

 

 

 

 

 

Dr Powell

Following our conversation from this morning; ?rst i want to thank you for your support. We are trying
to schedule a training session for the last week of A ril, 2012 for DSAT FTEs (5 participants). 1 am
waiting to hear back froml decide on an exact date. To answer your
question: the requirements to enter thelu?5353?3?2a last time were TB test and pmof Program
respiratory fit test. Again thank you for your support.

6
Accession Number: Specia191714 Page: 1003 Sean Date: 2014?09-1? COPY

Failure testing treatment
Fanfanure Ve??ca?en

Vivarium
Centers Buildin


 

Accession Number: Specia191714 Page: 1020 Sean Date: 2014-09-17 COPY

 

ful?l; (CDCIOPHPRIDSAT)

       

 

From: Weyant, Rob 
Sent: Frida June 29, 2012 2:09 PM
To: We l- 

 

{has}
 
?3353

 


mire 
Isle was

  
  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

this? rages; [3361-142  I.
nznz=re242usoimam: lair-U?? Il?b""5' l.
rib-"ID: this: I
?33?s? 

Cc: mimicocmpapmosm

Subject: Email search

Attachments: DSAT Email Search at CDCdocx

Importance: High

Good afternoon folks,

Unfortunately I have an acute request for you. Earlier this week we received a congressional inquiry regarding safety
incidents in Building Part of the inquiry was a document request that involved Emails. A review of our Building
file indicates that you may have Emails relating to Building

 

I need you to go through your current and archived Emails and print out any that relate to safety incidents in Building

Please provide our rinted Emails to lie-oi no laterthan 11:00 Monday morning. Attached is a copy ofa
search strategy that ?3'35? developed that may assist you in scanning your Emails.

Many thanks,

Hob Weyant

Robbin S. Weyant, BSA)

Captain, USPHS (Rec)

Director, Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404-713-2001

Cell phone: 67'8v614?i?284

SiprNet: isatz09@iricp.dia.smil.mii

BSA 1" Vision: To be the preeminent resource for the safety and security agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that is
protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. [fyou are not the intended recipient(s}, any dissemination, distribution, or copying is strictly prohibited. [f you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Specia191714 Page: 1018 Sean Date: 2014-09?17 COPY

 

ruse: 

 

 

 

 

 

 

From: 
Sent: Friday, June 29, 2012 2:03 PM
To: Weyant, Rob were U-S-C- new:

 

 

 

 

    
     


Cc: (CDC: we:
Holt, James D.

252ath':

Subject: RE: Draft outline of letter to be discussed at 3:30 today from Barbara Rogers

 

 

 

 

Certainly. I'll see you at 2:30.

[bit?i

From: Weyant, Rob (CDCIOPHPRIDSAT)
Sent: Friday, June 29, 2012 1:56 PM

 

  
  
 

 

 

 

 

CDCIOPHPRIDSAT) I
2 this? coctoeHPRiDsm')
OJOGC)
Subject: FW: Draft outline of letter to be discussed at 3:30 today from Barbara Rogers

 

 

 

 

[13:13:42 U.S.C. 

 

 

 

Please see below. Would you be available around 2:30 to discuss this? I?ll set up the bridgeline from my office:

Call in nt ntberJTI

Pa sscodt 

 

Many thanks,

Rob Wevant

Robbin S. Weyant, Phi), 

Captain, (Rot)

Director. Division Select Agents and Toxins
Of?ce oi?Publie Health 'l?l'eparedness and Response
Centers For Disease Control and Prevention

Of?ce phone: 404?? 8?200!

(Tell phone: 67843 4-2232:

SiprNet: isale9@iricp.dia.smil.mil

 

Vision: To be the preeminent resourcefor the safety and security ofbioiogicoi agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lfyou are not the intended reeipient(s), any dissemination, distribution, or copying is strictly prohibited. Ilyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

From: Curry, Cecilia (CDCIOIDINCEZID)

Sent: Friday, June 29, 2012 12:30 PM

To: Menard, Barbara Rogers, Barbara A. Browning, Daniel A. 

Monroe, Steve Austin, A. Foster, Joseph A. Peeples,
1

Accession Number: Specia191714 Page: 1021 Sean Date: 2014-09-17 COPY

Amy B. Gallagher, M. Skinner, Thomas W. Hunter,
Edward L. (cocroorosop)

Cc: Nicholson, Janet Wiley, Sarah D. Meechan, Paul J. Weyant, Rob
Shepherd, Charles E. Brown, Tiffany J. Harrington,
Alexander W. Watzke, Elena M. (CDCIOCOOIFMD)

Subject: Re: Draft outline of letter to be discussed at 3:30 today from Barbara Rogers

Thanks
may be fine with writing the section under which his name is listed, but remember the building incorporates labs
from and ncird as well as ncezid

From: Menard, Barbara (CDCIODIOADP)
Sent: Friday, June 29, 2012 11:rbara Rogers, Barbara A. I 
3-7 Austin, A. Foster, Joseph A. Peeples,
Amy B. Gallagher, M. Skinner, Thomas W. Hunter,
Edward L. 
Cc: Curry, Cecilia Nicholson, Janet Wiley, Sarah D. Meechan, Paul J.
Weyant, Rob Shepherd, Charles E. Brown, Tiffany J.
Harrington, Alexander W. Watzke, Elena M. (CDCIOCODIFMD)
Subject: Draft outline of letter to be discussed at 3:30 today from Barbara Rogers

 

   

 

From Barbara Rogers:

All -- below is a proposed outline for the response to the Energy and Commerce Cmte letter, and suggested
lead person responsible for writing draft on each topic. A few notes:
I I'm not sure if I've listed the appropriate person for some portions of the letter {like the 2 w! Paul and
Rob}, please advise if someone other than person listed here is appropriate lead.

 

 

 

Much of the narrative from table can be adapted for portions of the letter; I?m
assuming other parts can be drawn from material already developed by Tom Skinner;

 

I If at all possible, would like to have all parts by Monday afternoon, no later than I'll pull together
letter incorporating input, and send out to all for review of draft Tuesday;

0 Please share w} anyone else who should have this, I'm sure l've left off some key folks.
Thanks to everyone for terrific collaboration on this!!
-Barbara
Outline for letter to EBC:

Brief overview re CDC 575% labs:
- Nature and importance of research and other work that takes place there mils:

- Description of building including

ogw re levellabs requested in question #1
ibii?i

2
Accession Number: Specia191714 Page: 1022 Sean Date: 2014-09-17 COPY

 

 

 

 

 

 

0 features important to ensuring biosafety, redundant systems

 

Acknowledge small number of incidents occur; when they do, CDC swiftly addresses by: [Tom Skinner]
- assessing
impact,
- determining cause,
- swiftly addressing to prevent future occurances

February 2012 incident [Tom Skinner]
Brief discussion of other incidents, CDC response [Paul Meechan,
Rob Weyant]

- Including description of documents we?re providing re reports of biosafety incidents
at labs, in response to question #2

 

Brief discussion re safety (non-biosafety} issues/documents wf levellabs [Paul
Brief summary of 2007 incident wf stormfpower failure
Description of recommendations made, or steps taken or being considered, to address [Rob Weyant,

Paul Meechan]
safety issues at building level El labs




Barbara A. Menard

Deputy Director, Washington Office
Centers for Disease Control and Prevention
202-245?0560

bmenard@cdc:gov

3
Accession Number: Specia191714 Page: 1023 Sean Date: 2014-09?17 COPY

 

 ?we 

From: Thomas Ft. Frieden 

Sent: Friday, June 29201211945 AM

To: CDC All - CDC ATSDR and non-CDC 8: 
Subject: Laboratory Safety

Dear Colleagues:

CDC Chief Operating Of?cer Sherri Berger sent you an e-mail on June 13, 2012, regarding laboratory science
at I write to provide follow-up. This week, CDC Connects ran a s_to_ry about the extraordinary
accomplishments of our laboratory staff and those who work to keep our staff safe. Since the Building High
Containment Laboratory opened in 2008, more than 32,000 hours of scienti?c work have been accomplished
without one lab-acquired infection or release of a pathogen.

Our guiding principles for laboratory work are to:

0 Ensure the safety of all of our staff.

Prevent the release of any potentially harmful pathogens.

I Be as transparent as possible about our work, with the exception of information that cannot be shared for
security or legal reasons.

It Be open to suggestions and concerns from all individuals, particularly those working in these areas.

Conduct the highest quality scientific research to support our public health mission of protecting people
in this country and around the world.

 

I want to bring you up-to-date on several incidents regarding the Building [new I
which have received media attention. The ?rst was a potential leak of air from an animal room because of a
door closing too rapidly. No animals were in the room, no pathogens were released, no risk of infection
occurred, and the problem has been addressed by adjusting the speed at which the doors close and ensuring that
the door operation is regularly monitored during preventive maintenance. The second incident relates to fire
safety. In the event of a catastrophic event, there is a scenario in which several doom would be more dif?cult to
open than they should be. Although this scenario is extremely unlikely, we need to resolve the situation and are
exploring how to remedy this problem as soon as possible. We continuously evaluate ways to further improve
laboratory safety and welcome suggestions on ways to do so. To address a third issue related to oversight, we
are inviting outside experts to review our facilities and, if necessary, suggest further

improvements. Furthermore, while I have confidence in the professionalism and independence of 
Division of Select Agent and Toxins staff, in order to avoid the appearance of a con?ict of interest, the
Department of Agriculture?s Animal and Plant Health Inspection Service (APHIS) unit will lead all select agent
inspections of CDC laboratories going forward. Fourth, security systems identified potential lapses in access
control for staff within these were addressed in 2010.

 

The work in  is done by highly skilled and trained staff with Specialized
biosafety equipment and multiple layers of security systems to protect staff and the public. At no time during
these incidents were CDC workers or the public at risk. Safety is achieved through personnel training and
responsibility, protective equipment, facility engineering, and careful experimental design. All of these factors
contribute to a safe working environment. We are committed to addressing any challenges and only conducting
lab work in a manner that ensures the safety of our workforce and the public.

 

I am committed to communicating with staff in a timely and clear way and to listening to any concerns and
suggestions from staff. It is our obligation to ensure that people both feel safe and are safe in the

1
Accession Number: Specia191714 Page: 1024 Sean Date: 2014-09-17 COPY

workplace. Staff who work in the laboratory should continue to be vigilant and report potential safety and
security concerns to the CDC Security Operations Center at 404-639-2888.

In laboratory work as in all of our efforts, we are committed to a process of continuous improvement. If you
have any other concerns or suggestions, please do not hesitate to contact Joe Henderson, the senior of?cial who
will coordinate response to lab safety concerns. His contact information is or 404-639-7131. If
Joe is unavailable please contact Sherri Berger at sob8@cdc.gov or 404-639-7000.

We remain deeply committed to the health and safety of CDC employees and the public.

Thomas R. Frieden, MD, MPH
Director, CDC, and
Administrator, ATSDR

2
Accession Number: Specia191714 Page: 1025 Sean Date: 2014-09-17 COPY

 

lml'?? (CDCIOPH PRIDSAT)

 
 
 
    
    

From: Weyant, Rob (CDCIOPHPRIDSAT)
Sent: Friday. June 29. 2012 7504 AM
To: Henderson1 Joseph (CDCIOCO

 

Cc: Khan, Ali 8. (CDCIC 
(bits:


 

 

 

. 1: 

 
  

 

 

 

 

 

 

 

 

I (?1?53

Meechan, Paul J. 

I'ibi'?i' Ilibii?? 
Subject: Timeline - Building timeline with DSAT inputs 062912
Attachments: Timeline - Building timeline with DSAT inputs 062912docx

Good morning Joe and

Attached is the Building timeline with the DSAT injects. We are nearing completion of the collection and
reproduction of the DSAT inspection, registration, and incident investigation documents needed for the inquiry. We are
working with NARA to obtain a few inspection the 2005-2007 time frame, but hope to have those

today. We?ll be in over the weekend to do a QC review of the package and will provide it to you on Monday.

 

I?m planning to be on annual leave next week. W. libi'i?i llmil?? land "mils?  wil  be available to address DSAT
issues while i?m gone. I?ll have my BB in case ofemergencv.

Let me know if you have anyI questions or concerns.
Thanks,

Rob Wevant

1
Accession Number: Specia191714 Page: 1027 Sean Date: 2014-09-17 COPY

CDC Building Laboratory Project Timeline

zoos: Building was commissioned

 

10f4f2005: OSAT inspects 3? lab) for initial registration.

June 2006: Ellabs start lab activity

 

 

iosa,42
5.0

W1

 

 

June 13, 2006: DSAT inspects storage only) for initial registration

9n92i=

 

lab} for initial registration.

 
 

June 14, 2006: DSATinspects whips-C-

invivarium i1

   

January 15, 2003: DSAT inspects ?3:334
vivarium] for initial registration.

. laboratory and mitP-S-C-

February 2003: Design fol-El isolation began. The Elisolation project was conducted to isolate the
airflow ofthe labs from the rest of the vivarium to correct inadvertent air flow from between labs.

 

May 27-30, 2003: DSAT inspects facility  i and this?? ?50- 2323'? Ifor sea for initial

registration. -

 

Sept 24, 2008: Labs begin work in

 

October 27, 2003: DSAT inspects Fm?42 2523??: Iin lvivariurn for and performs renewal
inspection for the remainder of the registered select agent rooms and labciratones.

February 2009 - May 2009: Construction on El isolation. The labs were down during this time.
The rest of the vivarium remained functioning except for a few weeks in April 2009. This project was self-
commissioned.

April 16, 2009: Fans in both El and vivarium were tested, email sent to staff

 

May 2009: Animals moved in to vivarium [ferrets moved into suite 31' 

 

May 13, 2009: infectious work begins in vivarium by the 33 3?
October 2009: inspects animal facility.

October 2009: Design for vivarium air redirection began. The purpose of the air redirection project was to
minimize the size ofthe potentially centaminated areas within the vivarium, Specifically in the return corridor.
Doors were also upgraded and end users were involved in pre-design.

February 2010: Facilities engineers update scientists on air redirection project

 

fer use asI Iby Wm?? I

 

March 11, 2010: DSAT inspects . 
0'30?? 12-22. 2010: DSAT conducts renewal inspection of CDC facilities 

November 2010 January 2011: Construction for the vivarium project occurs

Accession Number: Specia191714 Page: 1028 Sean Date: 2014-09?17 COPY

January 2011: Vivarium goes live after air redirection.
December 2011: Vivarium shut down for annual maintenance. lab activity continues.

December 13, 2011: DSAT inspection of $3311.930'

 

February 16, 2012: Air puff incident occurred
February 16?17, 2012: Engineers evaluated the area

February 20-24, 2012: Adjustments were made to two doors in the area

 

April 25, 2012: DSAT meets with?  
analysis.

and others to discuss vivarium incident and subsequent

May 1-3, 2012: DSAT meets with various ARE, OSHE, and BFO staff to discuss ??3?33?342 vivarium incident.
May 3, 2012: DSAT conducts smoke testing in 2131*? vivariu m.

June 14, 2012: Egress doors were tested for force required to open under normal circumstances. Pressure was
found to be within the 15 psi maximum force allowed by code.

Accession Number: Specia191714 Page: 1029 Sean Date: 2014-09?17 COPY

 

Itbirf?i: I  fb1l53 I PRIDSAT)

 

 

 

 

  

 

     

 

 

 

From: - 

Sent: ursay, une 3, 2012 5:53 PM

To: We ant Rob 

Co:  I?I'rbt?i-
this: We: we? wit-6':
We It?ll-?J 


Subject: RE: Timeline

Dr. Weyant,

knows ofand

 

Timeline -
mwm?mm

 

From: Weyant, Rob 

   
       

 

 

 

 

         
     

Senmntedn?idasirJJne 2012 9:06 AM H:

To:_ we (cociopHpRiDSAT); 

Cc:   i cociOPi-ipwoss'r - (cooper-warmer);
(CDCJOPHPRIDSAT)

 

Subject: FW: Timeline

Good morning folks,

  
 

Please see below and attached. ?3?31? could you pEease pEug in the dates of the various DSAT inspections.
could you please provide mil? with dates of any additional inspections, investigations, or site visits that the 
Team did at Building during this time.

 



please send me, and Imii?i Ithe timeline with our activities when completed.

 

 

 

Many thanks,

Rob Weyant

Robbin S. 

Captain, 

Director. Division of Seieet Agents and Toxins
Ollie-e of Public Health Preparedness and Response
Centers For Disease Control and Prevention

Oti'it'e phone: 8-2??l

I(Dell phone: (HS-(ii 4-?284

Sipri?iel: 

USA Vision: To be the preeminent resource for the safety onor security of otoiogieol agents and toxins.

1
Accession Number: Specia191714 Page: 1030 Sean Date: 2014-09-17 COPY

This document is intended for the exclusive use ofthe recipient(s) named above. it may Contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lfyou are not the intended recipientt?s}, any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

From: Henderson, Joseph 

Sent: Wednesday, June 27, 2012 8:34 AM

To: Weyant, Rob Meechan, Paul J. 
Subject: FW: Timeline

Rob, on this timeline can you add when DSAT was called into conduct inspections especially following the event this
past February. Just trying to get all of our actions on this timeline. Let me know if we need to discuss. Joe

Joseph M. Henderson

Director. Office of Security and Emergency Preparedness :5

Lead for the Consolidation of of Sustainabilityend the Logistics Management Branch in PGO.
Centers for Disease Control and Prevention (CDC)

US. Department of Heath: and Human Services

4046393131

Consolidation of OSHE, BFO, OSEP, the Office ofSustoinobility ond Logistics Monooement Branch

 

From: Daniel, Katherine Lyon (CDCJODIOADC)

Sent: Tuesday, June 26, 2012 12:20 PM

To: Frieden, Thomas (Tom) Arias, Ileana Villar, Carmen S. 

Cc: Hunter, Edward L. Henderson, Joseph Reynolds, Barbara S. 
Subject: FW: Timeline

As requested. I'm not sure of current status and use, but think it would be useful to post w/ other info.

e-c: File: Timeline - Building 6 26 12.docx be

Katherine Lyon Daniel, 



2
Accession Number: Specia191714 Page: 1031 Sean Date: 2014-09-17 COPY

CDC Building Laboratory Project Timeline

2005: Building was commissioned

 

10f4j'2005: DSAT inspects - - - (BRATT lab} for initial registration.

June 2006:

    

labs start lab activity

 

June 13, 2006: DSAT inspects lib-?13142 Istorage only) for initial registration

 

June 14, 2006: DSAT inspects 5 lab) for initial registration.

 

 

January 15, 2008: DSAT inspects ?1:334
vivariumj for initial registration.

facility in  fbli31142 I  Ilaboratorv and 

 

February 2008: Design for isolation began. The El isolation project was conducted to isolate the
airflow of the [Ilabs from the rest ofthe vivarium to correct inadvertent air flow from between labs.

 

May 22-30, 2008: DSAT inspects and U30- Ifor SPB for initial

registration.

 

Sept 24, 2008: Labs begin work in

 

 

October 22, 2008: DSAT inspects  in 3" 3'3 for and performs renewal
inspection for the remainder of the registered select agent rooms and laboratories.

February 2009 - May 2009: Construction on Elisolation. The labs were down during this time.
The rest ofthe vivarium remained functioning except for a few weeks in April 2009. This project was self-
commissioned.

April 16, 2009: Fans in both El and vivarium were tested, email sent to staff

 

October 2009: inspects animal facility.

October 2009: Design for vivarium air redirection began. The purpose of the air redirection project was to

 

minimize the size of the potentially contaminated areas within the 33- 3? specifically in the return corridor.

Doors were also upgraded and end users were involved in pre-design.

February 2010: Facilities engineers update scientists on air redirection project

 

 

March 11, 2010: OSAT inspects
October 12-22, 2010: DSAT conducts entity recertification of CDC facilities (renewal inspection}.

November 2010 January 2011: Construction for the vivarium project occurs

Accession Number: Specia191714 Page: 1032 Sean Date: 2014-09?17 COPY

January' 2011: Vivarium goes live after air redirection.

December 2011: Vivarium shut down for annual maintenance. lab activity continues.

 

in facility for ?313342 .

 

December 13. 2011: DSAT inspection of ?"149-30-
February 16, 2012: Air puff incident occurred
February 16-12, 2012: Engineers evaluated the area

February 20-24, 2012: Adjustments were made to two doors in the area

 

April 25. 2012: DSAT (Biosafety Team] meets with and others to discuss (?1133142 viva rium

incident and subsequent analysis.

 

May 1-3, 2012: DSAT [Biosafety Team] meets with various ARE, OSHE, and BFO staff to discuss in??
incident.

vivarium

 

May 3, 2012: DSAT (Biosafety Team] conducts smoke testing in ?13334 vivarium.

June 14, 2012: Egress doors were tested forforce required to open under normal circumstances. Pressure was
found to be within the 15 psi maximum force allowed by code.

Accession Number: Specia191714 Page: 1033 Sean Date: 2014-09-17 COPY

 

DCIOPH PRIDSAT)

From: 


       

Sent: 3, 2012 2:2? PM

To: 
Subject: FW: Building vivarium

FYI --

4 L4. 

 

[0:15;

 

 

 



 

 

From: rm? ?mite:- 
Sent: Thursda May 03. 2012 2:10 PM
To: cocroeHPRlosar)
Cc:j  i= [bi-i5? 
Subject: RE: Building vivarium

 

 



 

      

i talked a few minutes ago on his wav downstairs to perform a coopie more interviews with CDC

 

   

facilities personnel, and he said that he has already spoken with Dr. Wevant and wiil be providing him with a written
report. [don?t have all of the information since I have not attended all of the interviews, but can tell you that the
vivarium rooms performed without airflow reversaEs today during smoke testing. ?131 3~ and I smoked some outer
lab doors at the clean corridor while CDC personnel donned PPE and entered vivarium rooms from the central corridor.
The CDC personnel opened inner suite doors and held them open for about 15 seconds, then allowed them to close, all
while we smoked the outer doors. There were no reversals of airflow observed at the outer doors. The vivarium doors
had been adjusted after the incident oecurred.

 

 

 

- 
Sent: Thursday, May 03, 2012 11:40 AM
To: ?i153 (CDCIOPHPRIDSAT)
Subject: RE: Building vivarium

 

Yes. that would be great! i think Drs. Wevant and would also be interested. but rnavr be planning to
debriet Dr. Wevant.

 

Rob is out until next week. one: wiEI be out all of next week. ilf be out Mon Thurs.

 

 

 

 

 

 

From: flit-5? (CDCIOPHPRIDSAT)
Sent: Thursday, May 03, 2012 11:36 AM

1
Accession Number: Specia191714 Page: 1043 Sean Date: 2014-09-17 COPY

 i 
Building

 

 

 

Do you think vou,  this? Iihii?i land libii33342 Iwould like me to dehrief you on the visit this morning to the
Building

 

 



 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS ?it-46

Atlanta, GA 30333

ijojil?j:

 

 

 

 

DSAT's vision: to be the preeminent rescurce for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientls] named above. It may contain sensitive information that is protectedmriviledged, or confidential,
and it should not be disseminated. distributed, or copied to persons not authorized to receive such Information. If you are not the intended be aware
that any disc o5ure, Copying. distribution or use of the contents ofthis document is strictly prohibited lfvou think you have received this document in error, please
notify? the sender immediatelv and destroyr the original. Thank Ivou.

2
Accession Number: Specia191714 Page: 1044 Sean Date: 2014-09?17 COPY

 

lists; I  lb3l53 

 

 
     

 

From: U.S.C. 252mb} 

Sent: Tuesda ,May 01,2012 4:12 PM

To: (cosioeHPRiosat?i
Cc: bit-5': 

Subject: Notes from the TLR Meeting with Centers 4.25.12

Please find a summary of the TLR meeting held on April 25, 2012 at 1:30 PM with Centers.

The following people were in attendance at the meeting held on April 25, 2012 in Building 20 room 8113:
libii?j: ?insz  IDSAT
ib;:i3;::42 0.3.0. a 252m: 05H 
mites}USE-seem: Land Rabies Branch 

I (use; PHB
Ken Bowen, 

Paul Probst, BFO

Carolyn Black, 05R
Pin, Pna

ibji3:42 DSELS

:r 

0555

William Howard, OSHE
U.S.C. 252mb; 

 

 

 

   

  

 

iajzisjzzia use. 252301;;

 

 

 

 

 

 

there is no immediate threat to public health. The Form 3 is still reviewing the Form 3 submission and supporting
documentation that was received on Friday, April 20, 2012. Interviews will be conducted and a walk through could be

performed once the review has been completed.

requested the names and contact information for all the individuals who may have been exposed during
that visit. She also stated that this training eve 1t ha not been relayed to the office and asked if this was tvpical
behavior. She stated that she expected for the office to be notified of any visitors entering registered space.

 

 

 

 

 

[bll?l
stated he would like to speak to Dr. Powell, safety and engineering staff who performed the building
evaluation, and staff from the ARE. A question was raised bv one of the attendants for clarification ofthe definition of

rimar containment versusfacilities. provided a res onse.
ll

    

 - - a that a formal written request be submitted that lists the names ofthe personnel that would
be interviewed. said a request would be submitted within the next 4?5 days.

stated the room contained na?ive animals at the time of the that had been received from
facility although the original report stated the room contained convalescng animals.

 

 

[bii?jz

 

 

 

 
  

[bit31z42 
2E2aih}

 

th

1
Accession Number: Specia191714 Page: 1045 Sean Date: 2014?09?17 COPY

stated she was aware of the incident on 2(24i12 and a Form 3 was not filed at that time because the
results of the risk assessment that had been conducted did not warrant it. She also stated her concerns over submitting
a Form 3 60 days after the incident occurred.

 

.  concluded the meeting by informing everyone he would be in touch after the review of the documentation
had been completed. Meeting concluded at 

Haunt-He

 

ibll?i

 

 

 

I 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Rd, NE.. Mailstop A46

ntlanra EH @0333

 

fillt?l

 

 

 

Vision: To be the preeminent resource for the safety and security ofbiofogicm? agents and toxins.

This document is intended for the exclusive use ofthe recipienits] named above. It may contain sensitive information that is protected. privileged. or confidential.
and it should not be disseminated. distributed. or copied to persons not authorized to receive such information if you are not the intended recipientts). any
dissemination. distribution. or copying is stricin prohibited. If you think you have received this document in error. please notify the sender immediately and destroy
the original. Thank you.

2

Accession Number: Specia191714 Page: 1046 Sean Date: 2014?09?17 COPY

 

 

    
 

 

 

 

 

 

From: (CDCIOPHPRIDSAT)
Sent: Aril 23, 2012 9:05 AM
To: minis:-

Cc:  this
(CDCIOPHPRIDSAT) 
Subject: RE: Centers Inspection

According to my recollection of the meeting with Dr Weyant, this affair is to be handled as a
TLR incident not a compliance inspection. This requires that we give the entity 7 days
(which we did) to submit the written account of the event (which they did} last Friday.

Part of the form 3 process involves an immediate assessment of risk to the public and to
the individuals potentially exposed to the SAT. Should it be determined that there is
signi?cant risk to either, immediate action is taken. If not, then a deliberate process of
information collection and analysis begins. We are not under the impression that there is
any significant risk that the visitors to the lab in question are at risk for developing '3 i-  
infections. So our plans are to ?nish reviewing the information we received from CDC

and set up a meeting and visit this week.

      

 

We will confirm the date and time with '3 i 3? and let you know.

 

libll?} I  JD.- I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

[hilt-i}

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents
and toxins.


From: the: 
Sent: Monday, April 23, 2012 8:40 AM
To": Imi'i?i  (CDC OPHPR 
(one: .
  I  
--: 
Subject: RE: Centers Inspection

 

 

 

 

 

 

   

 

 

 

Just saw 3?7 inspection will not occur today, and they have not determined when
they will start this week.

1
Accession Number: Specia191714 Page: 1047 Sean Date: 2014-09-17 COPY

 

From: Imi'i?i  DSAT)
Sent: Monday, April 23, 2012 7:36 AM

Tm 
Cc: (CDC (?3?33 this:

Subject: Fw: Centers Inspection

Importance: High

 

 

 

  
      

 
  

 

 

  

Hi all:

Are we proceeding with the compliance inspection of Centers today? Mary is recently back
from the field, is scheduled to participate in the lab tour, and needs a heads up to prepare.
Also, I'm short-handed today, and need to coordinate resources.

Let us know.

 

 

fbh??i

 

 

 

DSAT)
Sent: Saturday, April 21, 2012 09: 19 AM
To: rm: 

Subject: Centers Inspection

 

 

 

 

Iibjit?j:

 

 

Good morning. Just returned for Boston and was wondering if the inspection for Centers
will still occur on Monday. I haven't received any information from as yet. Hope
you have a great weekend.

 

 

 

 

Regards,

2
Accession Number: Specia191714 Page: 1048 Sean Date: 2014-09-17 COPY

 

(CDCIOPHPRIDSAT)

 

 

 

From: Ms: 
Sent: Fride An 012 4:56 PM
To' (CDCIOPHPRIDSAT)

 

Subject: Centers incident. forward 1 of 2

 

 

  


- 12, 2012 12:32 PM


 

 

 

Here?s what came out of the meeting today between Drs. Weyant, and Ilibii?i Ilibi?l?i llibi'?i land me
about the CDC biosafety incide   "curred during tours made by DSAT interagency partners to the Building
vivarium . Dr. Weyant directed [to treat the CDC incident as a potential TLR and to do an investigation just as if
it were any other entity. We?re Supposed to be sending ?313 is a letter tomorrow asking for additional information. It
sounds as though a brief inspection of the area by members of the biosafety team may occur on Monday of week after
next. I will be hap :1 to talk with you about details whenever you are available. You and Rob may also receive
information from 

  

 

 

 

Thank you for your help in providing a useful floor plan and the recent changes made to the pressure cascade.

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-46

Atlanta, GA 30333

 

[bll?l

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended forthe exclusive use of the recipientisJ named above. It may contain sensitive information that is protected,priviledged, or con?dential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientisl, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession NUmber: Specia191714 Page: 1049 Sean Date: 2014?09-17 COPY

 

 Ill-m: 

 

From: 

Sent: :riday, April 13, 2012 4:5? PM

To: 
Subject: Centers incident, forward 2 of 2

 

From: Weyant, Rob 
Sent: Friday, April 13, 2012 ?:52 AM
To: 
Cc: ibii?i ibii?i ?Jim: 
Subject: RE: Request for DSAT Training

 

 

 

 

 

 

 

 

Thanks very much, Eddy. We?ve been asked to do an investigation of this incident. has been assigned to
lead up the investigation. He may be getting back with you for additional information.

Best,

Rob Weyant

Robbin S. Weyunl. Phi"). itlii?ti?tBSM

Captain, LJSPI iS (Rut;

Director, Division ol? Helect Agents and 'l?oxins
Of?ce of Public Health Preparedness and Response
for Disease Control anti Prevention

(1 Elite phone; title-"ii S-EtiiJl

(Sell phone: (mi-6144284

Siprth: 

 

DSAT Vision: To be the preeminent resource for the safety and security of bioiogicoi agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. it may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lfyou are not the intended recipientts), any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

 

From: It's ., 
Sent: Friday, April 13, 2012 7'21 AM

To: Weyant, Rob 
Subject: RE: Request for DSAT Training

Good morning Dr. Weyant,

On February 16, 2012 escorted the training group over to Bldg. to a training session with ARB personnel.
was in charge of escorting us through the vivarium in building She gave us instructions on their day to
day activities and escorted us only through clean spaces. Because the group had been familiar with donning and doffing
PAPRs, had experience wearing PAPRs in animal spaces and the fact that they wouid have to shower out if they went

1

Accession Number: Specia191714 Page: 1050 Sean Date: 2014?09?17 COPY

into an animal room) they decided to just go through the didactic part of the training and not enter animal rooms. We
were told that we could observe the technicians through the window. I stated that we did not need PPE
in this area as it was ?clean?. We stood in the clean corridor at the door ne animal rooms and as the
technician opened the door from an animal room to the procedure roorn which was between us and the animal room},
a "puff" of air came through the slit in the window ofthe door, and con be felt in the clean hallway. and the inspector
from the Army [forgot his name} were close enough to feel it. I advised of what happened and she told
me that this was a clean room and no animals were infected in this room. She did, however, state that another room on
this corridor we did not observe anyone in it} did have infected animals in it. As we were walking back to building 20
and at least twice after we returned I miss: Ifrorr ented on what had happened in the
I sent an email to I [moireu.s.c.s262am:~ land copied um; Allison Williams, and Dr. Nathaniel Powell
stating what happened and inquiring if this was a "fluke" or the norm and if this was happening in the infected animal
room: had OHS and ARES done a risk ass   termine if there was any potential risk to anyone in the clean
corridor without respiratory protection, . wrote me back and said that he would look into it. I received no
more communication from him. I do think that there have been conversations between ARB staff and the Biosafety
group concerning this issue, I just don?t know exactly what.

 

 

 

 

 

 

 

 

  
 

Sincerely,

 

[bli?i

 

 

 

Division of Select Agents and Toxins

Of?ce of Public Health Preparedness and Response
Centers to Disease Control and Prevention

1600 CEifton Rd. NE MS was

333
[bil?i

Vision: To be the preeminent resource for safety and security of biological agents and toxins.

 

 

 

From: Weyant, Rob 
Sent: Wednesda April 11, 2012 7:28 AM

  
   
 
 

    

 

 

      

Tu: We 
I res: 
(CDCIOPHPRIDSAT)

Subject: FW: Request for DSAT Training

 

Good morning 3 3 3?

Please see below. has requested that DSAT perform an investigation of this incident. As a starting point, I
would like for you to provide me with a description of the incidentunderstanding that you were
there at the time. 

Many thanks,

Rob Weyant

 

 

 


Sent: Monday, April 09, 2012 4:02 PM

2
Accession Nomber: Specia191714 Page: 1051 Sean Date: 2014?09?17 COPY

 Weyant, Rob 
lei-r63 

   

I thought this would be of your interest. I have another email from - 33?? 3?
DSAT in future training sessions. I am not sure what exactly happened since that email

 

 

 

From: FDA-BI ?mire? Ili?biei-  
Sent: Monda April 09, 2012 3:4? PM

- i C. Powell, Nathaniel (CDCIOIDINCEZID)
Cc: Frieden, Thomas (Tom) CDCJOPHP 1 3*
Williams, Allison Fi?-3242;  
(CDCIOCOOJOSHE)
Subject: RE: Request for DSAT Training

    

 
     
 

 

 

 

ibjt?jtb?t??

 

 

 

 

 

From: the (CDCIOPHPRIDSAT)

Sent: Monday, April 09, 2012 10:49 AM

To: Powell, Nathaniel (CDCIOIDJNCEZID)

Cc: Irma;- ?in5] Ilb3'353 ?[5353 I (CDCIOIDINCEZID)
Subject: Request for DSAT Training

 

3
Accession Number: Specia191714 Page: 1052 Scan Date: 2014-09?17 COPY

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to schedule a
training session for the last week of April, 2012 for DSAT FTEs [5 participants]. I am waiting to hear back from 

Imiml?  decide on an exact date. To answer your question: the requirements to enter the last time
were TB test and proof of program;r respiratory fit test. Again thank you for your support.

 

4

Accession Number: Specia191714 Page: 1053 Scan Date: 2014-09?17 COPY

 

 ?was: 

 

 

From: - 
Sent: Frida Aril 13 2012 9:42 AM

To: (oomoer?rearosan
Subject: FW: Centers info

 

The Monday referred to below will be April 23?. 3 3" 3?
and should be in touch with inspection particulars.

has been informed of your participation,

 

 

 

Thanks, -- ibii?i

 

 

. . .l I 
(ogre;-

 

 

 

 

[bji?i

 

 

 



 

 

From: rise:  (cociopnpsiosm)
Sen? I I- 12,  12:32 PM.
To: (CDCIOPHPRIDSAT)
Cc: the? 

Subject: Centers info

      
  

 
 

 

 

 

 

Here?s what ca me out of the meeting todayr between Drs. Weyant, mi?? and Imii?i Ilibi'?? Ilibil?i ?this? land me
about the CDC biosafety incident which occurred during tours made by DSAT interagency partners to the Building
vivarium . Dr. Weyant directed to treat the CDC incident as a potential TLR and to do an investigation just as if
it were any other entity. We're suppose to be sendinga letter tomorrow asking for additional information. it
sounds as though a brief inspection of the area by members of the biosafetyr team may occur on Monday of week
after next. I will be happy to talk with you about details whenever you are available. You and Mmav also receive

information from

Thank you for your help in providing a useful floor plan and the recent changes made to the pressure cascade.

 

imia:

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A416

Atlanta, GA 30333

imis:

 

 

 

 

1
Accession Number: Specia191714 Page: 1055 Sean COPY

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientis} named above. It may contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. if you are not the intended recipientis}, be aware
that any disclosure, copying, distribution or use of the contents of this dowment is strictly prohibited. If you think you have receiyed this document in error. please
notify the sender immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: 1056 Scan Date: 2014-09?17 COPY

 

limit: I lib-?65' I (CDCIOPH 

From:
Sent
To:

Subject: FW: Biosafety complaint on the CDC campus

 

 

Mary:

Please see E-mail traffic below for Hit. I?ll send you another from - 3* 3'

 

 

I 
mite;-

 

 

 

 

 



From: (cocion?ieerosar)
Sent: Thursda Aril 12, 2012 11:54 AM

 

ibil?i

 

   

 

 

 

 

To: libii?i? (CDCIOPHPRIDSAT)

Cc: I (CDCIOPHPRIDSAT)

Subject: Fw: Biosafety complaint on the CDC campus

All?

See evmail trail below regarding an internal complaint ofthe ?33334 laboratories in building This will be handled as a
potential release, and ?33?53 will be planning a site visit. As the file owner and team lead, you should be aware
of the situation. See details below.

Thanks



FrOm: Wevant, Rob 
Sent: Wednesda April 11, 2012 ?:40 AM
To: [be the: lien?- ItcociOPHPRiositT);
r: i= ioni-ipniosm

(CTR)

Subject: Fw: Biosafety complaint on the CDC campus

 

  
   
 

 

 

Good morning folks,

Please see the below communications from Dr. Khan and other senior CDC leaders. We need to initiate an investigation
of this incident. in order to avoid the appearance ofa conflict of interest, we need to inform and invoive our APHIS
partners. I?ll be working from home this morning, but would like to meet with you tomorrow to discuss.

Please set up a meeting for the folks on this message.

Many thanks,

Rob Wevant

1
Accession Number: Specia191714 Page: 1057 Sean Date: 2014?09?17 COPY

From: Khan, Ali S. 

Sent: Tuesday, April 10, 2012 6:49 PM

To: Weyant, Rob (CDCJOPHPRIDSAT)

Cc: Austin, A. Sosin, Dan 
Subject: Biosafety complaint on the CDC campus

Exactly like the recentompiaint, please deveiop a thoughtful and measured plan.

Given that some may perceive that CDC is inspecting itself, if our response calls for an inspectionjinvestigation after
discussion with the R50, we should consider the team composition.

Thank you,

A .

From: Henderson, Joseph (CDCIOCDDIDSEP)
Sent: Tuesday, April 10, 2012 6:21 PM

To: Arias, Ileana Berger, Sherri Seligman, James D. (CDCIOCDOJDD)
Cc: Khan, Ali 5. Khabbaz, Rima Bell, Beth (CDCIOIDINCEZID)
Subject: Re: Complaint of Biosafety violations on the CDC campus .

Ileana, Sherri, and Jim, many staff from the 3505 and from NCEZID were engaged in discussions today related to the
issue that ??3'353' I?bii?i  raised pertaining to a perceived safety issue in the lab in the 
We are working on a one-pager related to this event but need program input which we will have in the morning. Nate
Powell had a meeting with today and i wanted to hear how that went before we finalize our full assessment of
this issue.

 

 

l?ll get this to you first thing in the morning.

Joe

From: Arias, Ileana 

Sent: Tuesday, April 10, 2012 02:54 PM

To: Henderson, Joseph 

Subject: RE: Complaint of Biosafety violations on the CDC campus

Thanks. Let me know what is going here and what if anything weaned to do.

Message-m-

From: Henderson, Joseph 

Sent: Tuesday, April 10, 2012 1 1:10 AM Eastern Standard Time

To: Berger, Sherri Seligman, James D. Khan, Ali S. 
Bell, Beth Khabbaz, Rima Chu, May Arias,
Ileana (CDCEOD)

Cc: Meechan, Paul J. Chandler, Gearge Henderson, Joseph
(CDCIOCOOIOSEP)

Subject: FW: Complaint of Biosafety violations on the CDC campus

 

All, I have asked Paul Meechan to setup a meeting today with OSHE, BFO, 31 from NCEZID,
from and me to get the facts on this complaint and assure we are all completely clear on this issue before further
actions are taken. I be sure to provide an update once we have the call and have the facts straight and actions clear,

2
Accession Number: Specia191714 Page: 1058 Sean Date: 2014-09?17 COPY

Keep in mind I'm taking the heim on this iSSue in my new rote providing oversight of the process to consolidate OSEP,
OSHE, BFO, Sustainability and Logistics Management from PGO. Just in case you are curious as to why I initiated this
email. If anyone wants to discuss please let me know.

Joseph M. Henderson
Director, Office of Seeurity and Emergency Preparedness

Centers for Disease Controi and Prevention (CDC)
U. S. Department of Hearth and Human Services


 

?3:131:42 LJ.S.C. 

 

 

 

3
Accession Number: Specia191714 Page: 1059 Sean Date: 2014-09?17 COPY

Ali

 

From: Weyant, Rob (CDCIOPHPRIDSAT)

Sent: Tuesday, April 10, 2012 8:50 AM

To: Khan, Ali 5. Austin, A. Sosin, Dan 
Subject: Fw: Request for DSAT Training

Good morning foEks,

FYI, please see below. I've asked my folks to follow up and brief me on the incident. The tour was supposed
to be at a portion of the facility that was undergoing maintenance and cold.

Rob Weyant

Robbin S. Weyani, RBHABSA)

Captain, USPHS 

l'Jirector, Division of Select Agents and 'l?oxins
Oflice of Public Health Preparedness and Response
tfjenters i?or l'fJisease Control and Prevention

Of?ce phone: 

lC?eli phone: {?it-ti ltl-i'lfisl

SiprNet: 

DSAT Vision: To be the preeminent resourcefor the safety and serun?ry of biological! agents and toxins.

This document is intended for the exclusive use of the reeipient(s) named above. It may contain sensitive information that is
protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
sueh information. lfyou are not the intended reeipiends), any dissemination, distribution, or copying is strictly prohibited. lfyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

 

From: Imil?i 

Sent: Monda Aril 09, 2012 4:02 PM

To: libii?i Weyant, Rob 
Cc: 1- 3 

Subject: FW: Request for DSAT Training

Dr Weyant and

I thought this would be of your interest. have another email from saying how pleased she was lo help
DSAT in future training sessions. I am not sure what exactly happened since that email

 

 

 

From:  (cocromincezro)
Sent: Monday, April 09, 2012 3:4? PM
To- We? c. (cociOPHPRiosrlT); Powell, Nathaniel (cociomincezm)

 

 

 

 

 

 

Ce: Frieden, Thomas (Tom) It?? lee-?13
Williams, Allison i=1 
(cociocoO/OSHE)

Subject: RE: Request for DSAT Training

4.
Accession Number: Specia191714 Page: 1060 Scan Date: 2014-09?17 COPY

 

U.S.C. 

 

 

 

 

 

9~ 5 

Sent: Monday, April 09, 2012 10:49 AM

To: Powell, Nathaniel 

Co: We? Imj'? Militia? 
Subject: Request for DSAT Training

 

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to
schedule a training session for the last week of April, 2012 for DSAT FTEs {5 participants]. I am waiting to hear
back from WINE ?who decide on an exact date. To answer your question: the requirements to
enter the ?1?34 last time were TB test and proof of program! respiratory fit test. Again thank you for your
support.

 

5
Acce351on Number: Specia191714 Page: 1061 Scan Date: 2014-09?17 COPY

 

 

 

Ions:- 

  

 

 

 

 

 

 

From: Weyant, Rob (CDCIOPHPRIDSAT)

Sent: Thursday Ari 12,2012 1:28 PM

To: -i=i  -  

Cc: Chu, May ?m5? lib??- I ml?i?l
(bits: (bits: liblli?i; ?one: I
- one (CDCIOPH Khan, Ali 8.
Holt, James D. (CDCIDCDOIDGC)

Subject: RE: Report Requested

 

Thanks very much for this report. DSAT has initiated an 

I?m-5" I this" Iwill be coordinating our work and he, along with ?315? will be in
touch with - 3"3 3 . . . regarding possible follow-up requests that we may have. Thanks in
advance for your assistance.

 

 

 

 

 

 

Sincerely,

Rob Weyant

Robbin s. Weyant, 

Captain, USPHS {Rot}

Director, Division of Select Agents and Toxins Of?ce of Public Health Preparedness and
Response Centers for Disease Control and Prevention Of?ce phone: 404-718-2001 Cell
phone: 678-614-7284 

SiprNet: isat209@iricp.dia.smii.mil

DSAT Vision: To be the preeminent resource for the safety and security of biological agents
and toxins.

This document is intended for the exclusive use of the recipient(s) named above. It may
contain sensitive information that is protected, privileged, or confidential, and it should not
be disseminated, distributed, or copied to persons not authorized to receive such
information. If you are not the intended recipient(s), any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

Messae--?-?
 Sm; - ma 
Sent: Thursday, April 12, 2012 12:53 PM
To: I?Difci?it?rg [maid?EU-S-Ci Weyant, Rob DSAT)
Cc: Chu, May 
Subject: RE: Report Requested

     

 

 

Rob,

1 am attaching the final version of the report generated detailing this event.

1
Accession Number: Specia191714 Page: 1062 Sean Date: 2014-09?17 COPY

 

 

-??-?Origina1 Message-nu
 

 

 

 
   


Subject: RE: Report Requested

Rob,
I am resending with the attachment.

Regards,

  



From: (CDC 

Sent: Thursday; April 12, 2012 10:03 AM

To: Weyant, Rob 

Cc: Chu, May 
Subject: Report Requested

Good Morning Rob,
I understand that you have requested a copy of the attached report.
[1 Attachment]

Respectfully submitted,

 

U30. ZEZanh}
2623

   

[b}[3}242 U.S.C. 2623[h;

 

 

 

2
Accession Number: Specia191714 Page: 1063 Sean Date: 2014-09?17 COPY

 

I m12l33242uscs262am: 

 
      
 

From:

Sent

To; . 

Cc: [b3l33z42 use. 262m; 

Subject: RE: request from October 2010
[bll?]

 

Thank vou for your e-maii below. I will forward this over to PI Kat: for action on the requested items.

Best regards.

 

[0131242 USE. 252mm

 

 

 

av

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE. Mail Stop #22

Atlanta, GA 30333

 

[0131242 USE. 252mm

 

 

 

From: W3 
Sent: Monav, Marc 1, 2012 2:10 PM

TO: use. 2523 
Cc:  
Subject: request from October 2010

 

 

 

 

 

 

APHIS has reviewed the information you provided to support request to work withI (bile-r42 U-S-C- a 252M I
concurrently and to perform experiments to look for re-assortment and has determined that they need an official
request {amendment} in order to provide a decision.

For this amendment, please provide the following:
1} Cover letter requesting to add this work and where work would be performed.
2} For each location where this work would be performed:
a. Section on that includes strains of possessed, or submit strain information separately.
b. Section with Section EB, question 1 updated to include the specific additional work requested.

I asked APHIS if there was any additional information needed so it could be requested along with the
amendment. Please see comments below.

1. Submit an official request: Provide a cover letter on an official entitv letter head describing the
. -. - - -- -- -
time (we will handle this as an amendment updating Dr. Katz? statement of work). Resubmit the original

1
Accession Nomber: Specia191714 Page: 1064 Sean Date: 2014?09-17 COPY

    

documents with the cover letter {t can resubmit the information ondfioor pions you previously provided on
November 9. 2011) and include any additional supportive documentation that may be needed for the review.

2. CDC stated that ?The experiments outlined in this document do not pose any greater or different risk than the
experiments currently taking place in our Laboratories.? Please provide the risk analysis (Ex-
environment. staff} for this decision and explain why the experiments outlined in the document do not pose a
greater risk and there is no need for additional biosafety and security concerns.

 

3. Please provide a copy of the current Biosafety Plan {should include and if applicable, any proposed
revised sections for work with  use. 252m:  viruses simultaneously.

 

 

I apologize for the length of time this has taken. In retrospect, I think it being a question rather than an amendment
caused delays and I should have requested that we process this as an amendment initially.

Thank you

 



 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Ftoad NE MS 
nta GA 30333

fblt?)

 

 

DSAT mission: We regulate the possession. use. and transfer otselect agents and toxins and the importation of etiological agents, hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. priviieged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this email.

2
Accession Number: Specia191714 Page: 1065 Sean Date: 2014-09-17 COPY

 

(him: 

 

  
 

 

 

From: (CDCIOPHPRIDSAT)

Sent: 2012 8:15 PM

To: - 

Cc: I  

Subject: update egistering animal holding and procedure rooms for

 

 

 

 

 

The specific rooms to be registered at lb?? and will need to be specifically called out on Section 6A to register
the animal holding and procedure rooms as swing space. lwill detail below. I will also include a suggestion to
consolidate the Section 5 and 6's submitted to reduce the amount of paperwork required both in this amendment and
to use as a starting point for any future changes to these suites.

 

at U.S.C. 252mm
Submit only one Section 5 and 5

Section 5 Header

 

 

 

     

 

 

 

 

Include]? I ijbj:i;3j::42 USO.  252mb; Ias Iaboratow rooms
. gag-1.5
Include and use. 26 as safety levels
Section 6A
Amend the row for RVF to include the swing space rooms  (as detailed below}.
Agent: Laboratory Area: Room =l ?3133342 IStorage Area 

throneuscszeain:  Laboratory Safety Lovel - i3 :3

Section der
Include  U.S.C. 2523th

Include Irma? I 

   

Section GD, question 13 attachment
Please provide a separate attachment for Section ED, question 13 that describes work conducted at only.

 

Work at ibjzrajzz42 use. 2a2arh;
Submit only one Section 5 and 6

Section 5 Header
Include I ?136142 U-S-C- 262m Ias la boratory rooms
include and NIHBL4 as safety levels

 

 

 

Section 6A
Amend each rowfagent to include the swin space rooms  Ilas detailed below}.
Agent each agent Laboratory Area  Storage Area 

 

 

HERE m" (more use. 262m Laboratory Safety Level as currently reflected for each agent

Section Header

Includel Ias laboratory rooms
I I I: 1:242

Include and us}; 25 as safety levels

      

1
Accession Number: Specia191714 Page: 1066 Sean Date: 2014-09-17 COPY

 

[Out of Scope]

[Out of Scope]

I 
H. r; 5 999' use. 252301}

 

 

 

   

 

U.S.C. 2E2C-lth}

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. priviieged, or
confidential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mait.

2
Accession NUmber: Specia191714 Page: 1067 Sean Date: 2014?09-17 COPY

 

 Ill-ea: 

 

 

   

From: DSAT IT Support 

Sent: a January 25. 2012 9:03 AM

To: mm [wereuse-mm: I 
Cc: m3r3:.:42 U.s.c.?2szarn: - 
Subject: pdates in Amendment,

 

 

Thank You

 

[$63242 U.S.C. 252a[h]

 

 

 

 

 

From: I?m? 

Sent: ?vthednesdayr January 25 2012 9:0? AM

To: Dclil nin;:i3;::42 u.s.c.?2szain3 I (CTR)

Cc: .  
Subject: RE: UTE-55 Updates in Amendment I CDC

ocean-r-

  
    

Iittli3?i42 U.S.C. ?2623H1l

 

 

 

 

Please proceed with this request.

Regards. --

 

[bjt?j

 

 

 


DSAT Vision: To be the preeminent resource for the safety and security of bioiogicai agents and toxins.

This document is intended for the exclusive use of the recipient(s} named above. It may contain sensitive information that
is protected privileged. or confidential. and it should not be disseminated. distributed. or copied to persons not authorized
to receive such information. if you are not the intended recipientt?s}. any dissemination. distribution, or copying is strictly
prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

1
Accession Number: Specia191714 Page: 1068 Sean Date: 2014-09?17 COPY

 

From: DSAT IT Support (CDC)

Sent: Wednesday, January 25, 2012 9:03 AM
To: (me; mire: I
Cc: ?ii-l5? - 33 3*


Subject: RE: [33.32 Updates in Amendment

 

 

 
 

 

 

   

?*After this ticket is approved by DSAT management it will be 
1 Ill
Tiekethas been assigned.

Thanks

 

rte-rs;- DSAT Technical Trainer
Lockheed Martin Corporation
Civil-Health 31 Human Services
6 Executive Park Suite 200
Atlanta, GA 30329-2205
Officel {bird} I
LM Email
CDC Ema

 

 

 

 

[bli?i

 

 

 

 

 

 

 

 

From: (CDCJOPHPRIDSAT) (CTR)
Sent: Wednesday, January 25, 2012 8:4? AM

To: DSAT 1T 5U ort (CDC)
Cc: memes-CE252m:- CDCIOPHPRIDSAT) 
(CDCIOPHPR DSAT) I.

Subject: Updates in Amendment 

 

     


[bjtt'3i142

 

 

Request: Within pending amendment? please change the safety level irom? . i:
in lab "Building itoorn

to for the foliowing relert
Suite. storage ?NonefNone 

   

    

GENE enrryHill? pendme amendment :Iugf?fg 252I3led?5u uhzuige the with Itwei 'trorri [or the lollnu-nd: sciot'; ul?dt??t 
I [b93142 I in Eat: [aide-"rumn "Building lit-101133006, storage bitig-"ronru "Noller'None"  

   

USE. 2E2a[h}

 

[0}[33242 U.S.C. 252301Within pending ere-case change tile 51  lot-oi Irom inr Iollma ?uiIt'LJl .igCi'?lb-?5142 Im iah "Building l-lrzitin ,ture. storage ?NoriefNone lor l?l -- l; -

 

 

 

fur the. I'izilltirrillg.J select upon! entry.
Suite, storage liitlg mum ?Nurlei?Nonc? I'ur i'i '3 

I rinj:r3;::42 use. 252arhj: liar it?Ih bitfgz?room ?Building  bloom

 

J. i - 
?t?tdllin elnondsnent v' please ul'iane'e the safety level I'i?Uli'l

 
 

 

Priority: High
Justification: Business rule will not allow change.

 

2
Accession Number: Specia191714 Page: 1069 Sean Date: 2014-09-17 COPY

 

love: I lime: DCIOPHPRIDSAT)

 
  

 

 

 

From: 

Sent: -  er27.201?i 1:32 PM

To: 

Cc; limit:- IA. 
Subject: use ofl litii'itt42 IViruses checklist

 

On Dec 13. 2011. and inspected a suite {procedure and animal holding room) inside the Ti 3? vivarium at
Centers for the group. The group is current register - ?1 other rooms within this vivarium which follow
the same procedures and are registered for the same agents? ?it? animals. and scope of work.

The currently registered rooms were inspected during the  Cict 2010 renewal inspection. Our intent was to inspect the
physical asper added. as the procedures and work were already reviewed last year. We did not
complete the that?? Viruses checklist as I was unaware that this checklist existed until last week.
The inspection report has already been sent to the entity.

 

 

   

   

 

    

U30. 

Should 1 fill out the . lViruses checklist retroactiveiy for this inspection? would need to
request information from the entity to complete.)

 

 

[bit?l

 

 

 



DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the impertation of etiological agents. hosts. and vectors of
human disease to protect the pubiic health in the United States.

This document is intended for the exctusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. if you are not the intended
recipient. any dissemination. distribution, or copying is strictly prohibited. If you think you have received this doCument in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

1
Accession Number: Specia191714 Page: 1070 Sean Date: 2014-09?17 COPY

 

 

 

  

 

  
 

 

 

 

  

 

From: 

Sent: ber 22, 2011 1:45 PM

To: ?3315? I.  (CDCIOPHPRIDSAT Lask --
[bill-?42   

Cc: Probst, Paul E. Ho (CDCIDCOOIQSHE Bowen, Ken
L. [sews-C- we:
Weyant, Rot: (CDCIOPHPRIDSATL - 


Subject: RE: Vivarium air?ow tests

Thank you for your acknowledgement of completion of this request for DSAT, and a special thank you to all at the Roybal
Campus who worked to fulfill the request.

Warmest wishes for Happy Hoiidaysi

 

 

 

[b3i33142 USE. 2E2ath;

 

 

 

 

 

- :r  (cocxoroupaxosm)

Sent: Thursday, December 22, 2011 10:1? AM

To: Lasky, Robert D. (cocrocoorosw); 4: 


Cc: Probst, Pa. Howard, William (Bill) Bowen, Ken L. (CDCIOCOOIBFO 
were, {trig-e42, (cocxompaxosar); Weyant, Rob 
we: (cocyorvupayosm)
Subject: RE: Vivarium air?ow tests

 

.  

 

 

 

 

 

 

 



The HVQC verification of the select agent registered space at your facility has been successfully completed.
I would like to express my very sincere thanks to everyone involved in the extensive work needed to perform and
document these tests. Thank you all very much, and i hope that everyone has a Merry Christmas.

1
Accession Number: Specia191714 Page: 1071 Sean Date: 2014?09?17 COPY

Yours truly.


ibil?i

 

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biotogical agents and toxins.

This document is intended for the exciusive use of the recipien?s) named above. it may contain sensitive information that is protected?riviledged or confidential.
and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. if you are not the intended recipientis]. be aware
that any disclosure, copying. distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error. please
notify the sender irrirnediatelvr and destroy the original. Thank you.

 

From: Lasky. Robert D. (CDCIDCODIDSHE)

Sent: Thursda December 22. 2011 10:03 AM

To: 

Cc: Probst. Paul E. Howard, William (Bill) Lasky. Robert D. 


Subject: Vivarium airflow tests

All

 

I met with ?3'35? -  - from DSAT earlier this morning to clarify points of observation during the Dec. 20
testing of airflows in the building vivarium. Afloor plan indicating where airflow was monitored and the
directional airflow observed was given to ?3'35? after our meeting.

The plan shows testing was performed at ante room entrances, procedure room entrances. and animal holding
area exits. Also. autoclave area and shower room entrances.

Hope this helps to better inform everyone.

 

Happy Holidays.

Dwayne Lasky

Safety and Occupational Health Manager
Office of Safety. Health and Environment
Centers for Disease Control and Prevention

 

 

Accession Number: Specia191714 Page: 1072 Sean Date: 2014-09-17 COPY

 

loo ?we 

 

     

 
  

From: this? 

Sent: Thurscav, December 22, 2011 10:17 AM

To: Look Robert D. (cocrocoorosuei; brews-0- we?
in?? 

Cc: Probst. Paul E. [3.6.42 ard, William (Bill) - Bowen. Ken

   

 

L. - 
Wevantl Rob 3 


Subject: RE: Vivarium airflow tests

  

 

 

The verification of the select agent registered space at vour facility has been successfully completed.
I would like to express my very sincere thanks to evervone involved in the extensive work needed to perform and
domment these tests. Thank vou alt very much, and I hope that everyone has a More; Christmas.

Yours truly,

 



 

 

 

DSAT's vision: to be the preeminent resource for the safetv and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientts] named above. it may.I contain sensitive information that is protectedprivilodgerj. or confidential,
and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended be aware
that am; disclosure. copving, distribution or use of the contents of this dotturneiit is strictlv prohibited. livou think you have received this document in error, please
riotilv the sender immediater and destrov the original. Thank you.

 

From: Laskv, Robert D. (CDCIOCOOIOSHE)

 

Cc: Probst, PI (cocrocoorsFo); Howard, William (Bill) {cociocooroseeh Lasltv, Robert D. 
(cocioeHPrvosm)

Subject: Vivarium air?ow tests

All.

1
Accession Number: Specia191714 Page: 1073 Sean Date: 2014-09-17 COPY

I met with from DSAT earlier this morning to clarify points of observation during the Dec. 20
testing of airflows in the building vivarium. A floor plan indicating where airflow was monitored and the
directional airflow observed was given to after our meeting.

The plan shows testing was performed at ante room entrances, procedure room entrances, and animal holding
area exits. Also1 autoclave area and shower room entrances.

HOpe this helps to better inform everyone.

Happy Holidays,

Dwayne Laskyl

Safety and Occupational Health Manager
Office of Safety, Health and Environment
Centers for Disease Control and Prevention

   

2
Accession Number: Specia191714 Page: 1074 Sean Date: 2014-09?17 COPY

 

Irma: HC 

 

From: 
Sent: Wednesda Setember 28, 2011 12:56 PM
To' 

 

Subject: FW: HVAC testing recap

 

 

From: Imus? 
1 11:48 AM

 

. . 

 

 

 

[Hilda-id

Thanks to you, User-?s 2623 and all the other gentlemen who took the time to meet with me today. Here is a recap of our
conversation: 

 

 

 

LI
First we discussed the current status on the HVAC testing for 1 am not aware that any of these
results have been provided to date to DSAT.

 

[Out of Scope]

 

 

 

Building

For the lab in building suite}, there were initial tests performed when the lab was first brought
online, and witnesses at that time observed that the HVAC system operated as required to maintain secondary
containment. The facility engineers intend to reconstruct the tests which were performed and to write up the
observations which were previously made, and that should be completed within a few weeks.

   

    

vs: 42

The 5.575% lab in building  use. s26 suite} is scheduled to be tested next Thursday 10KB, a

 

 

to DST the following week, providing the testing is successful. For the building vivarium .c [33:42 2523??;

and uite}, the exhaust fan failure tests have been successfully completed. Power failurefrestart testing for the
vivarium is planned to be performed in December during a maintenance shutdown.



 

[Out of Scope]

 

 

 

Accession Number: Specia191714 Page: 1075 Sean Date: 2014-09-17 COPY

 

[Out of Scope]

 

 

 

New Reguest

One thing which I did not say during our meeting but which I am requesting now is that DSAT be provided with the
results of the power failure/restart tests for the building Espaces and the results of the exhaust fan failure tests for the
building vivarium spaces. Because it was said todav that these tests were successful, I would appreciate getting the
results to whittle down the list of remaining items and to be able to demonstrate the total amount of progress made
toward completing this project. 1 am also requesting that an update be provided to DSAT, once available, on th
lab suite] results even if potential problems are noted, for the same reason.

Summary;

it is my opinion that a significant effort is being made bv registered entitv CDC to complvI with request to perform

HVAC verification of the registered areas. It is understood that performing these tests, making anv
necessarv HVAC modifications and then doing subsequent retesting can be verv labor intensive and time consuming. I
told vou that I thought that the December retesting projection for the building vivarium power failurefrestart would
be accepted by DSAT because other registered entities have been encouraged to perform the tests during maintenance
shutdowns. The use of annual leave bv testing personnel prior to the end of the year and the December holidavs could
present problems, however, for meeting this projection. Please consider whether these factors reduce the likelihood of
this timeline being met, and provide either a confirmation or a revised estimate for the building vivarium retesting
date.

 

It is probable that the inspection will remain open until this testing has been successfullv completed. Please let me know
if anything stated about the testing status in this email is inaccurate.

Yours trulv,

 

[blj?]

 

 

 

2
Acce531on Number: Spe01a191714 Page: 1076 Sean Date: 2014-09-17 COPY

 vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientls] named above. It may contain sensitive information that is protected,privi edged, or canfidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientis}, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

3
Acce531on Number: SpeC1a191714 Page: 1077 Scan Date: 2014?09?17 COPY

 

rm:- 

 

 

 

      
    

 

 

 

 

 

 

From: Isis: 

Sent: Thursoay. September 08, 2011 3:11 AM 

To: Weyant, Rob usagma (cocroeHPRiosmi;  I

(CDCIOPHPRIDSAT)

Subject: RE: Checking in

 

i have reviewed the AJC article on the @35- lab and the duct taped door, and it states that the lab lost its negative air
pressure after an HVAC restart. I toidhat the previous test results would be fine if they include both exhaust fan
failure and power failurelrestart. We always have the option of asking questions about the results which are provided.

 

 

From: Weyant, Rob 

Sent: Thursday, September 08, 2011 ?:22 AM I
-  (CDCIOPHPRIDSAT - [be-=42 isle?? . 

3 (cocropHpexosAT)

Subject: RE: Checking in

   

  

 


Are vou happv with the testing of the it: lab, as described below?

Let?s plan on getting all parties together around the end of this month unless all testing has been done and reported to
us.

Thank;

Rob Wevant

 

the? 
ursday, September 08, 2011 37:16 AMI
To: Wevant, Rob mist-:42 mews-0- we:
  sie- 
Subject: FW: Checking in

 

  
 
 
 

(cocropHpaiosnT);

 

 

Good morning,

Here is an update from Ken Bowen on HVAC testing plan.

 

 

mire;-

 

 

 

1
A009551on Number: Specia191714 Page: 1078 Scan Date: 2014?09?17 COPY

 



 

 

 

vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientis]: named above. It may contain sensitive information that is protectedpriviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended be aware
that any discloswe, copying, distribution or use of the contents of this document is strictly prohibited. If you thinlt you have received this in error, please
notify the sender immediateiy and destroy the original. Thank you.

 

From: Bowen, Ken L. (CDCKOCOOJBFO)

Sent: Thursday, September 08, 2011 6:33 AM
To: (cocioPi-iperosar) mm
Cc: Meechan, Paul J. [cociocooiosnE); less
Subject: RE: Checking in

 

 

 

 

. Bowen, Ken L. (CDCIOCOOIBFD)

 



What we have found for the power outage test in some cases it is simpler to just turn off the power to the whole building.
We have so many interlocks and safeties build into our new buildings it is harder to create a simulated outage than turn of
the entire building and deal with the issues that this procedure causes.

 

When we modified the HVAC system in to the redundant fans system, we tested this lab just like the criteria
mentioned in the Policy on BMBL 5?h Edition Laboratory Facilities {Secondary Barriers) Standard that was given to us
during our last meeting. OSHE and our office both observed the air flow through a magnehelic gauge and certified that
the lab was working before we went hot. We will give a document that certifies this observation as record of this testing.
We will not retest this area just use our previous observations. Keep in mind the sealed doors were never part of the lab
functioning properly. Our test was performed with normal lab doors where the sealed doors are today and stiil had proper
directional airflow. These doors were added later as a result of an MC article.

 

We will also be submitting data from the previous project to verify proper air flow for iabsl ?1393342 I.
All other labs are scheduled to be tested on September 15, 22, and At the beginning of October we will have a better
picture of where we are. .

Thanks,

Ken Bowen

Director for Facilities Engineering Office
404-639-3303 Office

404?639-0499 Fax

 

 

From: this (cocroenpniosar)
Sent: Friday, September 02, 2011 8:36 AM
To: Bowen, Ken L. (CDCIOCOOJBFO)

Cc: Meechan, Paul J. (CDCIOCOOIOSHE)
Subject: Checking in

2
Aocessaon Number: Spec1a191714 Page: 1079 Scan Date: 2014-09-17 COPY

Dear Ken,

There is a little more information that I wanted to provide you on the HVAC verification testing and the
rooms to be tested:

For the powerfailurei?restart test, DSAT is not requiring that any entity actually shot offthe normal power and perform
a load switch, because ofthe disruption this may mean for building occupants as well as the potential hazards to
electrical components during a load switch. If you wish to perform the test as a load switch, that is an option, but the
power failurefpower restart tests could instead be done as a simulation by simultaneously shutting off both the supply
and the exhaust fanis) which serve the laboratory rooms, while monitoring and recording the room differential
pressmes or airflow, and then simultaneously turning on the supply and exhaust fans, while monitoring and recording
room airflow or pressure.

After our meeting last week, I talked with about Building 5 j? 25 suite (the one with the pressure-sealed
laboratory doors), and she showed me which of the doors on the floor plan have been fitted with gaskets. The gasketted
door at the suite entrance to the main open containment space appears to have a series of three doors between it and
the containment boundary, making the possibility of an airflow reversal outside of containment via this route very
unlikely. The other gasketted door in room is between a room and directly outside of containment. There
are two options for suite for confirming the facility design to prevent airflow reversal under failure conditions.
One option is to provide the result of a leak test, such as a soap bubble test, ofthegasketted door, confirming
that the door is air tight. The other option is the performance of the HVAC failure scenarios as discussed last Friday.

 

Please let me know when you will have any update on test results or a testing plan. If you have any final test results, you
could email them to me directly if that is convenient.

Thank you,

 

lbjfi?j:

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named above. It may contain sensitive information that is protected,priviledged, or con?dential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. Ifyou are not the intanded recipientisi, be aware
that any disclosure, copying, distribution or use of the contents of this doCUment is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

3
Accession Number: Specia191714 Page: 1080 Sean Date: 2014-09-17 COPY



 

 

Yes, that is it.

 

to,
[33:42
USO.
a one

 

 

 

ibii?}

 

 

 

 

A-46

r.  

 

 

 

DSAT Mission: "We regulate the possession, use and transfer of select ogen ts and toxins and the importation of etioiogicoi agents, hosts,
and vectors of humor: disease to protect public health in the United States?

 

 

From: ?01133-242  

Sent: Monda _Jul 02, 2012 11:34 AM
To: (cocioeHPRiDssT)
Subject: RE: Centers inspection facilities

 



252mm

 

 

 

Please clarify that this is all you have.

 

 

 

From: rel-E:  
Sent: MOHCWZ, 2012 11:18 AM

To: lease: 9  252:: 
Subject: Fw: Centers inspection facilities

 

 

 

 

This is the closest I can find, which of course is an email you already have. It does not list any specific building.

 

[bins-42
U.S.C. 
262ath;

 

 

 

 

(bii?l

 

 

 

1
Accession Number: Specia191714 Page: 1082 Sean Date: 2014?09?17 COPY

 

rats:

 

 

 



DSAT Mission: ?We regulate the possession, use and transfer ofseiect agents and toxins and the importation of etioiogicoi agents, hosts,
and vectors of human disease to protect public health in the United States?

 

 

From: 
Sent: Monday, December 06, 2010 8:25 AM
To:  mars-4+2 (CDCIOPHPRIDSAT)
Subject: RE: Centers inspection facilities

 

 

I There were no problems with any of these items. I am going over each of the sheets this morning and will bring
them to you.

 

 

 

lb}le

 

Assistant Team Lead


ibj:[3::42 use. 

 

 

 

I I

 

 

 

 

 

 

 

From: this? 
Sent: aund bu  ber 05, 2010 2:02 PM
To:  (CDCIOPHPRIDSAT) mil-a; 

 

 

 

 

 

 

Cc: I leis?-  (cocr0PH PRIDSAT)
Subject: Centers inspection facilities

 

Hello I
I need to complete facilities questions on IE5 and checklists.
Please advise if yes can be recorded for the following items on these checklists for all Pl's or if there are problems.

No recirculation of laboratory exhaust air.

Lab exhaust air dispersed away from occupied areas or HEPA ?ltered.

D14 HEPA ?lter housing allows for leak testing of ?lter and assembly.

D14 HEPA ?lter and housing certified annually. (I have an Excel spreadsheet with 2009 dates and some other notes but I
need your help to interpret.)

Thank ou!

 

 

[birdi-

 

 

 

2
Accession NUmber: Specia191714 Page: 1083 Sean Date: 2014-09-17 COPY

 

[b38142 USE. 2523013

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended

recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please considerthe environment before printing this e-rnail.

3
Accession Number: Specia191714 Page: 1084 Sean Date: 2014?09?17 COPY

 

[bli?i

From:
Sent:
To:
Subject:

PRIDSAT)

Thank you,

 
   

 

 

RE: incident

 

 

U.S.C. 252a[h}

 

 

  
  
 




. -. . .. mber 09, 2011 12:55 PM

 



 

 

From ?11:15? DSAT)
Sent: Wednesday, November 09, 2011 12:56 PM

 

[him-:42

   

To;

 

cc: 3' 
Subject: FW:

 

incident

thew 


No additional information is required.

Thank you for reporting this incident.

 

[bif?]

 

 

 

   
 

Subject: RE:

 

 

 

. incident


 

 

 

Good Morning ?331

ibii?l
This does not appear to be a reportable event from a Form 3 perspective. However, Iwould like for to weigh
in on this since he is so familiar with the layout of the laboratory. He will be in the office on Monday and I will get his
take on it then. If there is further information reouired, I will let you know.

Accession

Number 


23, 2011 7:09 AM




Specia191714

1
Page:

1088

Sean Date:

2014-09-17

COPY

 

Best regards, [?5312
USC.



Sent: Thursda October 2011 3:2? PM
To:  
Subject: FW: incident

 

 

 

 

   

(CDCIOPHPRIDSAU

Please see email below regarding incident occurring at Centers today.

From: rugs? 
Sen In her 27, 2011 3:13 PM 
To; .- .
Cc: w'I 
Zambuto, Laura R. 
Subject: FW: incident

-

 

 

     

 

   

thirt?} ,(coc/ommcezm 

(cocrotorncezm);
irnj:rs:42 

Hall 

 

 

 

 

 

it
Please see re ort below from litii?li?ml I re ardin re ofdeviation from standard access
. 3 
procedure in our today. Let me know if any additional information is required from our entity as a result of this

OCCUTFEHEE.

Respectfully submitted,

 

[bl-[SE42 U.S.C. 26231203

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

ib3(3}242 U.S.C. 252mm

 

 

 

 

 

rag-3342, 21  (cocromrncezm)

October 27, 2011 3:09 PM

. 

Cc: ?53 Zambuto, Laura R. 1'1 
Howard, 1Wimam (Bill) (CDCIOCOOIOSHE)

Subject: incident

  

 

 

 

(cocrocooi'OSHE);

 

 

2
Accession Number: Specia191714 Page: 1089 Scan Date: 2014-09?17 COPY

   

-- - and 
{non-CDC and on campus to install a device in
restroom). The technician, who was not vaccinated against 
shower dirty side anteroom and entered a few fe I I irnon area. There was no activity in the grey area,
no person had exited from theor labs, and the door leading to the chemical
decon showers was not opened. I indicated to that I would communicate this incident, and after
returning to my office, I notified the Biosafety Manager (?"3314 ofthe incident and my intent of informing
the Pl After hearing the details of the incident, $54 was of the opinion that an exposure had not take
place, but that a violation of the access policy had. I later learned that the unvaccinated technician, who was scheduled
to receive a vaccination that day, was vaccinated withip an hour of the incident. I was unable to directly

after speaking with so I proceeded to send her an Email describing the incident. I later spoke with
in her office after which immediately called you to report the violation. In response to this
incident, corrective measures will be taken to 1) retrain the user who made the error, and 2} to add prominent signage
to the west side entrances warning that unvaccinated persons are not allowed to enter beyond the doors. I will work up
this signage and send it to you in the morning. As a last comment, I would like to say that the person who committed
the violation is one of the most dependable and conscientious users of the and predictably, is very upset over this
incident. Speaking from experience, there will be time when mistakes are made, but I have the utmost confidence in the
training and abilities of our users, as well as the oversight for the operation of the facility. We will further discuss
this incident at next week's Operations Group meeting. Best regards.

'1

.ed a member of the -3 - .  grouprivision escorting a technician
into the grey area ofthe west side of the [to use the
passed through the door out of the personal

 
 
   

 

 

 

 

[b38342 U.S.C. 252mm

   

   

 

       

 

use. 252mm

 

 

 

3
Accession Number: Specia191714 Page: 1090 Sean Date: 2014-09?17 COPY

 

  

PRIDSAT)

 

 

 

 

 

   

 

    

 

I
From: - --  
Sent: Thursday. December 22, 2011 9:28 
To: ?1?53 5?7" 
Cc: keel-=2; i' 
zi?a?thr 
Subject: FW: Vivarium airflow test

 

Please see report below provided from OSHE this morning regarding the Vivarium Airflow Test conducted on December
19, 2011. 

Best regards,
[b33142

 

 

U.S.C. 262301;:

 

 

 

 

From: Lasky, Robert D. (CDCIOCOOXOSHE)

Sent: Thur  :ember 22, 2011 8:45 AM

To: - Howard, William (Bill) Probst, Paul E. (CDCIOCOOIBFO)
Cc: 'i i=  (CDCIOCOOIOSHE) 

Subject: Vivarium air?ow test

  
  

 

 

 

All.

ated power failure test of building was conducted 19 Dec. to observe airflows in the vivarium on level

 

Observers were stationed at the outer {clean} corridors and the inner   'n-J 

Electrical disconnects for all supply and exhaust fans were pie?energized simultaneously. All doors maintained
negative or static airflows.

All fans remained off for a period of approximater 10 seconds. After restart all doors remained or returned to
negative airflow.

1
Accession Nomber: Specia191714 Page: 1097 Scan Date: 2014?09?17 COPY

Dwayne Lasky

Safety and Occupational Health Manager
Of?ce of Safety, Health and Environment
Centers for Disease Control and Prevention
404.539.49m



 

 

 

 

- 
dun-,2

2
Accession Number: Specia191714 Page: 1098 Scan Date: 2014?09?17 COPY

 

mite:   

 

 

 

  

From: 

Sent: Thursday, December 22, 2011 10:17 A I. 

Laskir. Robert D. eels? - .
 

- 3-4 

Cc: Probst. Paul E. (CDCXOCOO BF I 
Ken L. 
Wey


Subject: RE: Vivarium airflow tests

   
 

William (Bill) Bowen,
ions:


   

 

The  HVAC verification of the select agent registered space at your facility has been successfuliy completed.
I wouid like to express my very sincere thanks to everyone involved in the extensive work needed to perform and
document these tests. Thank you all very much, and I hope that everyone has a Merry Christmas.

Yours truly,

 

ibii?l

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biologicaE agents and toxins.

This document is intended for the exclusive use of the recipient{s} named above. It may contain sensitive information that is protectedmriviledsed. or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to such information. if you are not the intended recipientlsi, be aware
that any disclosure, copying. distribution or use of the contents of this document is strictly prohibited. If you think you have reteived this doCument in error, please
notify the sender immediately and destroy the originai. Thank you.

 

From: Lasky, Robert D. (CDCIOCOOIOSHE)
Sent: Thursday, December 22, 2011 10:03 AM
2 
Cc: Probst, Paul E. Howard, William (Bill) (cocxocoorosuei; (cocxocooxosms);
(coquHPwosan 
Subject: Vivarium air?ow tests

        

1
Accession NUmber: Specia191714 Page: 1099 Sean Date: 2014?09-17 COPY

All.

 

I met with from DSAT earlier this morninF to clarify points of observation during the Dec. 20
testing of airflows in the building vivarium. A floor on indicating where airflow was monitored and the
directional air?ow observed was given to ?i153 after dur meeting.

The plan shows testing was performed at ante room ehtrances, procedure room entrances, and animal holding
area exits. Also, autoclave area and shower room entrances.

Hope this helps to better inform everyone. 

Happy Holidays,

Dwayne Lasky

Safety and Occupational Health Manager
Office of Safety. Health and Environment
Centers for Disease Control and Prevention

I 

 

2
Accession Number: Specia191714 Page: 1100 Sean Date: 2014-09?17 COPY

 




    

 

 

 

 

 

 

From: [b39342 

Sent: Wednesda?' January 04, 2012 3:36 PM

To: [his Ilm-"t? 

cc: [stilt-4'2 u.s.c.s2s2a[n: ma; .  ..
[5389543523,  

Subject: Fw: as data for emergency poy'ver transition December 20, 2011

Good Afternoon

 

[11133242 U.S.C. 252mm
Members of BFO and OSHE met with I Ibirli?ir ?lb-?53? land on our team this morning to discuss your
request for data from the December 20 emergency power transition. Please see the statement provided by Paul Probst,
BFO, as response to your request.

 

 

 

 

Respectfully submitted,

 


U30. 2528

 
    

  

[bj:[3j::42
a 9.291

 

 

 

 

From: Probst, Paul E. (CDCJOCOOIBFOJ

 
   

--  - - - 3 9 Bowen, Ken L. 
Walpole, Kenneth K. ?1313342 Howard, William (Bill) (CDCJOCODIOSHE)
Subject: RE: data for emergency power transition December 20, 2011

 
   

[11:83:42

Submission of data reflecting operational parameters during BFO scheduled power shutdowns is not required per the
Bl'leL and is not maintained. Containment barriers were in place and functioning properly. No door alarms were observed
during the power shutdown; therefore, no loss of containment. During our regular annual lab shutdowns, door
gaskets and contact area is cleaned and visually inspected for integrity. Future lab shutdowns will include smoke testing
of the APR doors on the containment perimeter.

Thanks.

Paul Probst

 

From: 
Sent: Tue day January 03, 2012 11:32 AM
To: page {3135.422sat 

Cc: this? this? (cocror'HPonsar); writes-0 
a wen, Ken L. (cocrocoorsro); Probst, Paul E. (cocrocooiarot; this? Hutcocrocooiosm;

We (CDCJOPHPRIDSAT)

Subject: RE: AP data for emergency power transition December 20, 2011

Hi

 

 

 

      

 

 

 

 
  

   

I still haven?t heard anything regarding this request. Can you please help facilitate this?

Happy New Year!

1
Accession Number: Specia191714 Page: 1101 Sean Date: 2014?09?17 COPY

 

 

I?m-i (CDCIOPHPRIDSAT)

 r. ember 22, 2011 11:14 AM 

Bowen, Ken L. (cocxocooiam);
Probst, Paul E. cocxocoozeFO); coc?toorosnE)

Cc: --  (cocrosemseppm

 

      
 
  

   

 

 

 

  
  
     

Subject: Re: AP data for emergency power transition Dec her 20, 2011

No.

From: W4  

Sent: Thursday, December 22, 2011 08:56 AM

To: Imii'i?? lib-?53 Bowen, Ken L. 

 

OOIOSHE)
.- - - 
nsition Dec?htber 20, 2011

Probst, Paul E. 
Cc: W- 

 

 

Has anyone responded directly to you regarding your inquii?y below?

Best regards,
31,3142

 

[113133242 U.S.C. 2523111]

 

 

 

    

Bowen, Ken L. 

(CDCIOCOOIOSHE

Cc: (CDCIOPHPRIDSAT)
- 

 

Subject: AP data for emergency power transition 20, 2011

Good Afternoon All:

During inspection last week, we discussed today's schedul?tl power outage, transition to emergency power, and AP
trending. We would like to get copies of trends for Building it"s?? ?'30 2523??: Iduring this time. It?s

 

my understanding that the data is only archived for a perioH of a day or so.
Can you help please help with this?

Thank you.

thir?}

  

2
Accession Number: Specia191714 Page: 1102 Sean Date: 2014-09?17 COPY

 

I mire} I



 

 

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or con?dential, and it
should not be disseminated, distributed, or copied. If vOu think you have received this document in error, please notify the sender immediately and destrov the

original, thank you.

3
Accession Number: Specia191714 Page: 1103 Sean Date: 2014?09?17 COPY

 

 

 

 

 

 

     
  
  
   

 

 

I
From: 
Sent: Tuesday. March 27, 2012 1:04 PM
To: - (cocxompwos
Cc: 

Ulaw?za is?? 
Subject: Re: Building power
Thank you, I appreciate vour ciarification.
Sincerely,

 

[013,912

From: . 
Sent: Tuesday, March 27, 2012 12:53 PM
To: {53:53:43  
Cc: minis (CDCIOPHPRIDSAT - we

Subject: RE: Building power transfer

 

 

u-I'

 

 

  
 
 

 

 

 

 

. 3: i: 
 7'3 

 

All other labs keep records of this sort and provide them upon request. They do not send us emails, however,
notifying us of the tests ahead of time.

 


Sent: Tuesday, March 2012 12:32 PM
To: ?Us? Flt-"53 I. 

 

 

 
   

 

 
  

     

 

 

 

Cc: .. 
. 

Subject: Re: Building power transfer

I will be glad to pass this request aiong to our BFO personnel for action.

Please clarify that DSAT is making these similar requests of other registered entities based on notifications that they
receive on power testing. We want to be sure that these types of requests (based on e-mails DSAT receives as
general occupants at Rovbal Campus} are consistent standards to which other registered entities are held.

 

 

 

 

 

 

 

.  (cocropHPRiosan
Sent: Tuesday, March 2012 12: 1? PM

To: ease I [bars-=42  
Cc: [his minis 
Subject: Building power transfer 

 

 

 

 

  

 

 

1
Accession Number: Specia191714 Page: 1104 Sean Date: 2014-09?17 COPY

Tomorrow Building will undergo a generator lo?d test and the building will be transferred to generator
power during this test (please see attached CDC campus He announcement). We are requesting records specific to
Building use. 2mm:  during this trangfer of power.

Please let me know if there are any questions.
Thank you.

2
Accession Number: Specia191714 Page: 1105 Sean Date: 2014-09-17 COPY

 

[obi?l

 

 

 

Mission: We regulate the possession, use, and transfer of select lagents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It i'nay contain sensitive information that is protected, privileged, or confidential, and it
should not be disseminated, distributed, or copied. If you think you have received this document in error, please notify the sender immediatelyr and destroyr the
original, thank ?iron.

4
Accession Number: Specia191714 Page: 1107 Sean Date: 2014-09?17 COPY

 

 

 

 

 

 

 

 

 

From - - 

Sent: Tuesday, March 2012 5:34 PM

To: (CDCXOPHPRAPSATJ

Cc: FPO Frazier, Rodrick 

ions; Probst. Paul E.

icocxocooxsroi; Bowen, Ke' L. (cociocooxaroi; Howard, William (Bill)
i=  I igi


Subject: Re: Building power transfer

Thank you. I'll be glad to generate a written statement for DSAT and will forward it upon receipt of confirmation from
our Buildings and Facilities Office.

.  (CDCIOPHPRIDSAT)
Sent: Tuesday, March 22, 2012 03:31 PM
  i- - 
Frazier, Rodrick '11 
?3133:! 2 USE.

 

   
  
   

  

 

05E 

 

 
    

 

 

.. - Probst Paul E. (cociqcooiaro - Bow  :ociocooieroi; Howard,
William (Bill) (cociocooiosrlei; .-: Mi 

Subject: RE: Building power transfer

 

Thanks for the additional information.
I think all we will need in addition to this informatipn is a written assurance from you after
completion of the transfers that the emergency power transfer systems performed according

to design and there were no problems with the test.

Thanks again for your cooperation and support.

 

Irons,- ?lbizi?i:  I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta, Georgia 30333

 

ibii?i

 

 

 

1
Accession Number: Specia191714 Page: 1108 Sean Date: 2014-09-17 COPY

DSAT Vision: To be the preeminent resource for tl?l-?e safety and security of biological agents and toxins.

From: i= . it! 
Sent: Tuesda Marc 7, 2012 3:02 PM
To: This: 
(CDCIOPHPRIDSAT 
 - :?in - Probst, Paul E. cociocoo/BFO);
Bowen, Ken L. (coclocoolaFO); Howard, William (Bill) *1   
Subject: Re: Building power transfer

I have received the following information from our BFO tedl'n regarding your request below.

 

 
   
     
    

 

      

 

The activity will not result in a power interruption or loss of power, not even as a momentary blip. As a result and in
concurrence with OSHE, there is no intention to test contalhment during tomorrow's power transfer.

Additionally provided for clarification regarding tomorrow? scheduled activity, the load test initiates a closed transfer of
power from utility to generator. The control system will stah the generators, parallel the generators to GA [no loss
of power) and transfer the facility load to the generators.wi l remain on generator power for 1 hour. At the
conclusion, the system will parallel with GA {no loss of bower) and retransfer the facility load back to the utility.

Let us know if additional information is required at this time.

Sincerely,

    



[0:13:42 U30. 252301]

  

 

From: (cocioPHpRiosAT)
Sent: Tuesda March 27, 2012 12:1? PM

=1 i  m,
.  
Subject: Building power transfer

   
    

 

Tomorrow Building will undergo a generator lo?ld test and the building will be transferred to generator
power during this test (please see attached CDC campus tie announcement). We are requesting records specific to
Building [bi-[33342 U-S-G- 252ml?; lrluring this transfer of power.

 

Please let me know if there are any questions.
Thank you.

2
Accession Number: Specia191714 Page: 1109 Sean Date: 2014-09?17 COPY

 

I

 

 

 

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the Llnited States.

This document is intended for the exclusive use ofthe recipient named above. It lhav contain sensitive information that is protected, privileged, or confidential, and it

should not be disseminated, distributed, or copied. If vou think you have received this document in error, please notify the sender immediater and destrot,r the
Original, thank 1you.

4
Accession Number: Specia191714 Page: 1111 Sean Date: 2014-09-17 COPY

 

tingle: 

 



  

 

From: 
Sent: Thursday, April 12r 2012 12:32 PM
To: 
Cc: 
Subject: Centers info 

ibii?]

 

 

 

 

Here?s what came out of the meeting today between Drs. Weyq t, 

 

and ?ital-[El ?ibli?j ?ibji?j: land me
about the CDC biosafety incident which occurred during tours rqade by DSAT interagency partners to the Building
vivarium . Dr. Weyant directed to treat the CDC incid'pnt as a potential TLR and to do an investigation just as if
it were any other entity. We?re supposed to be sending   letter tomorrow asking for additional information. It
sounds as though a brief inspection of the area by members of! biosafety team may occur on Monday of week after

next. I will be happy to talk with you about details whenever V0 are available. You andmay also receive
information fro time:

 

 

Thank you for your help in providing a useful floor plan and the [ecent changes made to the pressure cascade.

 

[b 6 

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientls] named above. it may Eontain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipiehtis}, be aware

that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

1

Accession Number: Specia191714 Page: 1112 Sean Date: 2014-09?17 COPY

 

 

I urea: I

 

 

 

 

 

 

 

From: Weyant. Rob 

Sent: Friday, April 13. 2012 7:52 AM

To: 

Cc:  -  ME, icocxopnparosan
Subject: RE: Request for DSAT Training:

 

to,-
[33:42

Thanks verv much, use, We've been asked to do an investigation ofthis incident. 3?3 3'
lead up the investigation. He mav be getting back with you for additional information.

 

 

 

has been assigned to

 

BesL

Rob Wevant

Robbin S. Weyant, 

Captain. USPHS {Rec}

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404-? S-BGUI

Cell phOne: 67"3-6 I4-7234

SiprNet: 

DSAT Ivision.- To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lt?you are not the intended recipientts}, any dissemination, distribution, or copying is strictly' prohibited. lfyou
think you have received this document in error, please notify the sender-immediater and destroy the original. Thank you.

 

 

 

-  
Sent: Friday, April 13, 2012 ?:21 AM

To: Wevant, Rob 
Subject: RE: Request for DSAT Training

Good morning Dr. Wevant,

On February 16, 2012 I escorted the training group over to Bldg. to a training session with ARB personnel.
was in charge of escorting us through the ?31333? in building She gave us instructions on their dav to
day activities and escorted us only through clean spaces. Because the group had been familiar with donning and doffing
PAPHs, had experience wearing PAPRs in animal spaces and the fact that they would have to shower out if they went
into an animal room) they decided to just go through the didactic part of the training and not enter animai rooms. We
were told that we could observe the technicians through the window ?its? lstated that we did not need PPE
in this area as it was "clean". We stood in the clean corridor at the do imal rooms and as the
technician opened the door from an animal room to the procedure room which was between us and the animal room},
a "puff" ofair came through the slit in the window of the door, could be felt in the clean hallwav. I and the inspector

from the Army {forgot his name} were close enough to feel it. I gdvised of what happened and she told

1
Accession Number: Specia191714 Page: 1113 Sean Date: 2014-09-17 COPY

 

 

me that this was a clean room and no animals were infect?d in this room. She did, however, state that another room on
this corridor we did not observe anyone in it} did have inflicted animals in it. As we were waiking back to building 20
and at least twice after we returned the gentleman froriihe Army commented on what had happened in the yiyarium.
I sent an emaii toI land copied me; Dr. Allison Williams, and Dr. Nathaniel Powell
stating what happened and inquiring if this was a "?uke" oi? the norm and ifthis was happening in the infected animal
room: had-OHS and ARE. done a risk as terrdine ifthere was any potential risk to anyone in the clean

 

 

 

 

 

 

 

?3:131:42 U.S.C. 2522i
corridor without respiratory protection wrote me back and said that he would took into it. I received no

 

 

more communication from him. I do think that there have been conversations between ARB staff and the Biosafety
group concerning this issue. I just don't know exactly what.

Sincerely,

[bh?l?42 U.S.C. 252aih]

 

 

 

Vision: To be the preeminent resource for safety and secthy of biologicai agents and toxins.

 

From: Weyant, Rob 
Sent: Wednesday, April 11, 2012 7:28 AM
(CDCIOPHPRIDSAT)
(cocerHPRiDsnT); file? 
- - 

Subject: FW: Request for DSAT Training

     
 

 

 

Good morning

Please see below. Dr. Khan has requested that DSAT perfol?i?n an investigation of this incident. As a starting point.l
would like for you to provide me with a description ofthe il?lcidentunderstanding that you were
there at the time.

Many thanks.

Rob Weyant

 

 

 

 

 

ihjti?j: l- I
From: EEDCIOPHPRIDSAT)
Sent: Monday, April 09, 2012 4:02 PM
To:l  1 Weyant. Rob 
Cc: fit?? mi?? (CDCIOPHPRIDSAT)
Subject: FW: Request for DSAT Training

Dr Weyant and

 

   
  

 

2
Accession Number: Specia191714 Page: 1114 Sean Date: 2014-09?17 COPY

I thought this would be of your interest. I have another email from  saying how pleased she was to help
DSAT in future training sessions. I am not sure what exactly happened since that email

 

 

[bi-1233142 use. 

 

 

 

 

 

 

From: I: this? (CDCIOPHPRIDSAT)
Sent: Monday, April 09, 2012 10:49 AM
To: Powell, Nathaniel (CDCIOIDINCEZID)
cc: Irons} ?toils:  Iiblt?} I mils:
Subject: Request for DSAT Training

 

 

 

[bli?l 

Dr Powell

Following our conversation from this morning; first I want to the. you for your support. We are trying to schedule a
training session for the last week of April, 2012 for DSAT FTEs {5 Participants). I am waiting to hear back from


Accession NUmber: Specia191714 Page: 1115 Sean Date: 2014?09-17 COPY

 

Imi??i Ito decide on an exact date. To answel?jrour question: the requirements to enter the ?$33342 last time
were TB test and proof of program! respiratory fit test. Ag In thank you for your support.

4
Accession Number: Specia191714 Page: 1116 Sean Date: 2014-09?17 COPY

mus: ICDCIOPH PRIDSAT)

 

   

 

   
   

From: 
Sent: Saturday, April 14, 2012 10:41 
To: 
Subject: w: en ers etter 
Attachments: Centers TLR Letter t2).doc
FYI
Sent using Staci-cherry
From: 

2012 03:(cocioerRiosAT)


SUbject: FW: Centers TLR Letter (2)

Correction to previous sent email:

The 3}"u paragraph of the letter should read: 14?? and 16th instead of February 15th and 16th . Please note this
change on your copy.

Thank you,

 

[Dita]

 

 

 

USA 1" Vision: To he the i'esotii't'cjor the sojaty and security (Jht'dfngic'df agents and toxins.

This document is intended for the exclusive use of the recipienttsiI named above. it may contain sensitive information that is protected. pitviteged, or contidentiet.
and it shoutd not be disseminated. distributed. or copied to persons not authorized to receive such information. it you are not the intended recipientts}r any
dissemination, distribution. or copying is strictty prohibited. it you think you have received this document in error, ptease notify the sender immediatety and destroyr
the on'ginat. Thanh yeti.

From: use. 2 
Sent: Friday, April 13, 2012 3:08 PM

To: @9142  
cc: tolt?} thit?} ii: 33
this "this 
Subject: Centers TLR Letter (2)

 

 

 

[b'ii3ji42

  

 

 

 

. -- . II?rmra: 
.(coctOPHPRiosAT)

 

 

 

 

Good afternoon Iibj:t3}:42

1
Accession Number: Specia191714 Page: 1117 Sean Date: 2014-09-17 COPY

Please be advised, the letter attachment denoted in this ntl?mo will require your immediate attention and collaboration
in helping us to understand what happen during the visitor?s tours ofthe Vivarium in Building This event qualifies as

a TLR Incident and, therefore. subject to an investigation. 

Your sincere appreciation in collecting the facts surroundin?? this event is most appreciative.

Respectfully,

 

2
Accession Number: Specia191714 Page: 1118 Sean Date: 2014-09-17 COPY

sum-E
Lb

$3

 

5; DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
:11; Centers for Disease Control
?was and Prevention (CDC)

Atlanta GA 30333

April 13, 2012

 

U30. 262mb}
Centers tor Disease Control and Prevention
1600 Clifton Road, NE, Mailstop A-22

n1 

 

 

 

 

?31:23:42 U.S.C. 252mm

 

 

 

RE: Incidents During Visitor Tours of the Building Vivarium

 

 

On February 14, 2012 between a 41:30 am, escorted mitt? loser),
loser], we: and (APHIS) to the Building
vivarium space. Participants entered the contain:  - aring PAPRs and showered out
upon exit. On February 16, 2012 between 3 41:30 am, escorted a second group to the
viva 'ium: I   r.bj:is: I
and ME: 1 ,l The second group was giveri the option of touring the clean corridor outside
of containment; they chose this option and did not wea PAPRs. According to escort (?33342 as
the second group stood outside the door of room um:ng 

 
    
 

  

   

 

 

5305252 In the clean corridor, the ARB technician
inside opened the door to the animal room. As this door closed, a very noticeable puff of air could be
felt coming through the slit in the window out into the clean corridor.

 

An incident report was provided to DSAT from CDC. This report states that prairie dogs were
convalescing in the holding room after an experiment with virus. The BMBL states
that all persons working in or entering laboratory or animal care areas where activities with Wiliu-S-C-i
virus are being conducted sh0uld have evidence of satisfactory vaccination. The two groups of visitors to
the vivarium included individuals who had not been vaccinated fo 

 

 

 

In order to determine whether the visitors on February 1,5 and 16, 2012 were exposed to a select agent,
please provide the following information by COB on April 20, 2012:

Please submit a completed Form 3 along with an executive summary (narrative) of events
including timeline of what ocCUrred. 

- Please provide details on which rooms within the containment block were entered by the first
group of visitors. 

- Please provide information on the work activities being performed in all of the vivarium rooms
during the time intervals ofthe visit.

i What isfare the requirementis) for entry into the containment block?

a Explain the procedure for preventing entry of unvaccinated individuals into areas where
vaccination is required.

0 Please confirm the last time that active work was performed in procedure room 3 3?1
the tour by the second group.

I Provide details on the animal housing used throughout the containment block and including any
animals housed at the time in animal holding ropm

 

prior to

Accession Number: Specia191714 Page: 1119 Sean Date: 2014-09?17 COPY

 

a Previous HVAC verification test results proitlded to DSAT for the Building vivarium space were
qualitative and lacked room differential pr?ssure trending data. Please provide pressure
trending data for each of the rooms in the WW containment block during the time of the
second group?s visit on February 16, 2012.

   

[bjl33242 
2523lh}

       

If vou have questions concerning this correspol'ldence, please contac
the Form 3 mailbox at: form3@cdc.gov

On all correspondences regarding this TLR inve?tigation, please be sure to include
as well.

I
Thank you in advance for your cooperation and collaboration in this critical investigation.
SinCErelv,

i
Form 3 Site Visit Coordinator

23.3

 

 

 

fblt?? 
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Rd. NE. Mailstop A46
Atlanta no. mass

 

 

[biif33242 USE. 

 

DSA Vision: To be the preeminent resourcefor the sofed? and security ofbioiogicoi agents and toxins.

This document is t'rttendedfor the excius't've use ofthe recrpientt'sj merited above. it may contoin sensitive information that is protected. priviieged, or
con?dentioi, and it shouid not be disseminated, distributed, or copied  persons not author-ind to receive such information. Jyoti ore not the
intended recipientt?s). any dissemination. distribution, or copying is prohibited. Jyoti think you have received this document in error. pteose
noti?t the sender t'mm eo'iateiy and destroy the original Thank you.

Accession Number: Specia191714 Page: 1120 Sean Date: 2014-09-17 COPY

 

 

one: ICDCIOPHPRIDSAT) I

 

 

From: in!? 

Sent: Friday, April 20I 2012 4:22 PM

To: 

Subject: esponse to DSAT Request of April 13, 2012 RE: Incidents During Visitor Tours

 

of the Building Vivarium

 

I apologize for not including vou on the original Submission of my e-mail and attachments below.

I hope you have a nice weekend!

 

 

[0:[33142 USC. 252mm

 

 

 



 

   
       

 


will 
  



 


Subject: CDC Response to DSAT Request of April 13, 2012 RE: {ncidents During Visitor Tours of the Building Vivarium

Good Afternoon

 

Per your e-mail and attached letter of April 13, 2012, please find attached the CDC response to your request for me to
provide additional information regarding incidents that occurred in the Building Vivarium during tours on February 14
and February' 16, 2012.

Cover CDC Response to
DSAT Request 

 

1
Accession Number: Specia191714 Page: 1121 Sean Date: 2014-09?17 COPY

Respectfully submitted,

in

[hilt-'12 USC. 252%:

 

 

 

2
Accession Number: Specia191714 Page: 1122 Sean Date: 2014-09?17 COPY

Controlled Unclassi?ed Information

 

   ?3:13:42 
mi:u:3j::42 

 

 

 

 

 

 

 

To:
Dr. Richard E. Besser
Acting Director, Centers for Disease Control and Prevention

From:

 

 

 

?1:81:42 I I   
conjunction with the CDC Of?ce of Health and Safety

 

For Of?cial U?e Only

Accession NUmber: Specia191714 Page: 1129 Sean Date: 2014?09?17 COPY



Controlled Unclassified Information

 

 [0:61:42 USE. 262mb} IIncident

 

lb 

On February 12, 2009, an incident in the operation of the affected th  suite
(authorized for work with virus), which ulted in a momentary de?ation of a gasketed
shower door leading into the outer clean area ior to chemical decontamination of the shower
space.

   

Acoount of the Incident
Starting at approximately 12:25 pm, three men??aers of the and Rabies Brancgamma natal entered mm the Buildinn in  [Disease-Cs
 nh [Out of Scope]

[Out of Scope]

 

 

 

 

 

 

 

 

At 4:00 pm, when the inventory was completedi all four personnel entered into the
decontamination shower and attempted to initi?te an automated decontamination shower cycle.
The cycle failed to initiate, and instead, the dad? leading into the clean side de?ated.
Experienced lab workers realized that a probier'? had occurred and held the door closed until the
gasket re-in?ated. Ultimately, all of the personhel exited the shower (re-entered the main lab)
an goingi?edg 59:1 Seasons Environmental (bulding support), the and
the [hi The problem was quickly id?hti?ed - at approxima ey pm a ay', the
building automation system computer sy em monitoring and controlling the building),
failed to restore the decontamination shower oBEration to an enabled mode, after the lab brie?y
disabled, and then the entire lab, except the sther, re-enabled. Normal operation of the
decontamination shower was expeditiously re-dhabled, and all personnel exited the lab following
an appropriate decontamination process.

 

 

 

 

 

 

 

After the incident, thel Idiscussed
the situation and decided to halt all entry into  laboratory until details of the incident could be
investigated and a solution to the problem impl?mented.

Corrective Actions

The morning after the incident, a meeting of edhineering, program, OHS, and management staff
was condu - An error in the BAS software?'as identified as the cause of the decontamination
shower for not being automatically re?endhled and was corrected. A decision was made to
modify the BAS software code that same day td prevent such incidents and additional alarms
have been added to notify engineering personri?l.

    

During this incident, program and suppert pers?nnel acted appropriately, but continued
exercising of staff on the operation of the facilit?r is needed and will take place. In addition, the

I [hirer-r42 U-S-C- 2623th IOperations Group will analyze the incident and provide additional
corrective actions to safeguard against future irltidents in the

For Of?cth Use Only

Accession Number: Specia191714 Page: 1130 Sean Date: 2014?09?17 COPY

 

 

m6: PRIDSAT)

 

 

  

 

I
From: (CDCIOPHPRIPSATJ
Sent: Thursda Ma 03, 2012 2:27 PM
To: [seine U-S-C- a 262m: 
Subject: FW: Building vivarium
FYI --
[bli??

 

 

 

 

5gp

 

 

From: 
Sent: Thursda May 03, 2012 2:10 PM

 

 

 

 

 

TO: I- T3 ibjzi?}
CC: I 3 

 

Subject: RE: Building vivarium

i talked with a few minutes ago on his way downstairs to perform a couple more interviews with CDC
facilities personnel, and he said that he has already spoken with Dr. Wevant and will be providing him with a written
report. Idon?t have all ofthe information since I have not attended all ofthe inte. .f  an tell you that the
vivarium rooms performed without airflow reversals today during smoke testing. and I smoked some outer
lab doors at the dean corridor while CDC personnel donned PPEand entered vivarium rooms from the central corridor.
The CDC personnel opened inner suite doors and held them opep for about 15 seconds, then allowed them to close. all
while we smoked the outer doors. There were no reversals of airflow observed at the outer doors. The vivarium doors
had been adjusted after the incident ocourred.

 

 

 

 

From:   (CDCIOPHPRIDSAT)
Sent: Thursda May 03, 2012 11:40 AM
To: 
Subject: RE: Building vivarium

    

   

Yes, that wouid be great! I think Drs. Wevant and
debrief Dr. Wevant.

may be planning to

 

Ll

Rob is out until nextweek. p342 will be outallof next week. is



 

 

 

 

 

 

From: rule? 

1
Accession Number: Specia191714 Page: 1131 Sean Date: 2014?09?17 COPY

Sent: Thursda Mayr 03, 2012 11:36 AM
To: mini?:- (cociopprosnT)
Subject: Building vivarium

 


BUildinE vivarismr

 

 

and Im??42 ?5'0 2623?? Lvould like me to debrief you on the visit this morning to the

 

 

 

 



 

 

 

DSAT's vision: to be the preeminent resource for the safet? and securitv of biological agents and toxins.

This document is intended for the exclusive use of the recipientis} named above.? mav contain sensitive information that is protected,priviledged. or con?dential,
and it should not be disseminated. distributed, or copied to persons not authoriz to receive such information. If vou are not the intended recipientis], be aware
that ant,I disclosure, copving, distribution or use of the contents of this document is stricth prohibited. If you think vou have received this document in error, please
notify the sender immediately and destroy the original. Thank van.

2
Accession Number: Specia191714 Page: 1132 Sean Date: 2014-09?17 COPY

 

 

was: 

 

 

 

 

 

 

From: ?3:153 

Sent: Friday, March 02 2012 3:59 PM

:cocroennaxosm}; icocxopnpwosnn
Cc: [cocropH PRIDSAT)

Subject: RE: meeting request i'

This meeting is scheduled for Tuesday, March 6 at 2 PM in the DSAT conference room. will send a meeting
invite and includeand and myself. I'll meet true internal select agent and folks at the
elevators and bring them back to the conference room. (Note: the conference room is scheduled until 2 PM and again
starting at 3 PM so we have just the 1 hour window}

 

Rob - iwill forward the invite to you.

 

 



 

 

 

 

From:  (CDCIOPHPRIDSAT)
Sent: Pride In 2012 3:40 PM

      
     
 

 

To: 


i just talked to Rich. We are available any time on Tuesdav until 3:30pm.

Have a great weekend!

[b,io,

From: (use: (CDCIOPHPRIDSAT)
Sent: '-ri av, arc 2012 10:59 AM

 

 

  
 

Tm. . (cpciompwosm
Cc: 11  

 

Subject: FW: meeting request

 

Imus: '3 nd Imus:- I

Centers is requesting a meeting to discuss an observation from the inspection report. Would you like to schedule a
meeting, or address this in another manner?

From: 

 

     
  
   
   

 
 

2012 9:28 AM
CDCIOPHPRIDSAT)

    

-   [hie-=42 .
Probst, Paul E. Howard, William (Bill) Walpole, Kenneth K.
is? (cocrocoorOSHE)

 

(cocro 
?34"33'14 
Subject: meeting request

 

1
Accession Number: Specia191714 Page: 1135 Sean Date: 2014?09?17 COPY

Hi how are you?

We have had a request from OSHE and BFO to find out if a l'lheeting can be scheduled next week with DSAT
representatives to disCuss resolution ofobservation #13 n'dled on the DSAT inspection report dated February 29,

2012. This observation relates to providing records from tl'ie building scheduled power outage performed December
20, 2011.

If DSAT is able to accommodate our request, a Tuesdav aftarnoon, Wednesday or Thursdav meeting time would work
best for DSHE, BFO and the SA Compliance Team.

Thank you for consideration ofour request.

Regards,

 



 

 

 

2
Accession Number: Specia191714 Page: 1136 Sean Date: 2014-09?17 COPY

 

 

was} 

 

 

 

 

   


From:  
Sent: Friday, April 13, 2012 4:56 
To, - i=i i= 
Subject: Centers incident, forward 1 of 

 

From: (CDCIOPHPRIDSAT)

  
 

Sent 12, 2012 12:32 PM
To: -  
Cc: 

 

Subject: Centers info

 

 

Here's what came out of the meeting today between Drs. Weyq t, and lib-"E Ilmii?i Ilibii?i? land me
about the CDC biosafety incident which occurred during tours made by DSAT interagency partners to the Building
vivarium . Dr. Weyant directed to treat the CDC incident as a potential TLR and to do an investigation just as if
it were any other entity. We?re supposed to be sending a letter tomorrow asking for additional information. it
sounds as though a brief inspection of the area by members of! biosafety team may ocCL on Monday of week after
next. I will be hap - to talk with you about details whenever you are available. You and may also receive
information from lime:

 

 

 

 

 
 

Thank you for your help in providing a useful floor plan and the recent changes made to the pressure cascade.

Ifh"-fI-"" I

 

[bii?i

 

 

 


DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named above. It may contain sensitive information that is 0f ED??dE?tlal.
and it should not be disseminated, distributed, or copied to persons not authorized to r?ceive such information. If you are not the intended be aware
that any disclosure, copying, distribution or use of the contents of this document is stricity prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

1
Accession Nomber: Specia191714 Page: 1137 Scan Date: 2014?09?17 COPY

 

  
  

 



Sent: Tuesday, June 09, 2009 11:31 AM
T03 . (CTR)

Subject: RE: Facilityfsecuity review question

Same response, For the records please have one done.

 

 

 

 

 

 

 

[bli??
From: If?? Ill?? IA. (CTR)
Sent: Tuesda June 09, 2009 11:24 AM
Tm  
Subject: RE: Facilityfsecurity review question

Same question for security reviews.

Thank you

 

?3:133:12 U.S.C. 2523M:

 

 

 



This document is intended for the exclusive use of the recipient?) named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not be disse inated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient?s), any dissemination, distribution. or copying is strictly
prohibited. If you think you have received this document in errorI please notify the sender immediately and destroy the
original. Thank you.

 

libli?l (CTR)
Tuesda June 09, 2009 11:23 AM

[bi-?353 
ea {coercoTPEwosm (CTR)

Fciityfsecurity review question

  

 

 

There is a pretty old amendment for Centers, adding some suites in building that is about ready for approval now that
the inspection has finally closed out. ?333342 noticed that a facility review had not been done. Could you please let me
know if you want facility reviews done in general for areas that have already been inspected?

Thanks,

 

1
Accession Number: Specia191714 Page: 1138 Sean Date: 2014-09-17 COPY

 

I 2523th I

 

[b36142 USE. 2523ih}

 

 

 



Please consider the environment betore printing this e-meil.

This document is intended for the exclusive use of the recipientts} named ?hove. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated distributed, or copied to poisons not authorized to receive such information. If you are not the intended
recipientts). be aware that any disclosure. copying. distribution or use of tilt! contents of this information is strictly prohibited. If you think you have
received this document in error, please notify the sender immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: 1139 Scan Date: 2014-09?17 COPY

 

  



 

 

  
   

 

 

 

 

 


From: 
Sent: a March 01, 2010 10:1? AM
To: 
Cc: . Laura R. i=1 .. this?

Subject: nspection Date 9

 

Have you received confirmation that March 11'h will be the date for our inspection of the U35. uite in Building to be

registered to our ?3334 Division?

 

Thank you in advance for your assistance with this request.

Sincerelyl

 

ibjzr3::42 use. a 252m;

 

 

 

 

 

 

From: (CDCIOCODJOSEW
Sent: Monda February 22, 2010 12:19 PM
3 1  (CDCICOTPERJDSAT)
Cc: Zambuto, Laura R. (CDCICCIDINCIRD)
Subject: RE: ?1133342 Inspection Date

      

 

Thank you. we'll look forward to hearing from you soon.

Sincerely,

 

use. a 252arhj:

 

 

 

1
Accession Number: Specia191714 Page: 1140 Scan Date: 2014-09?17 COPY

 

03383142 U30. 2623M:

 

 

 

 

 

From: he: W, cocrcorpenrosm)
Sent; Honda Febru 2010 11:02 AM

 

 

Division of Select Agents and Toxins

Centers for Disease Control and Prevention 
Office of Public Health Preparedness and Response 
1600 Clifton Road MS A46

Atlanta, GA 30333

U.S.C. 252aih3

 

 

 

 

http: KW. sclectagentseov

This document is intended for the exclusive use of the recipientiS?l noted above. It may contain sensitive information that is protected,
privileged, or confidential, and It should not be disseminated, distribu d. or copied to persons not authorized to receive such Information. if
you are not the intended recipient(s}, any dissemination, distributioni or copying is strictly prohibited. If you think you have received this
document in error, please notify the sender immediately and destroy ihe original. Thank you.

 

 

From: Ilbi?i?? ?militif,? I (CDCIOCOOIOSEP)


R. 1*  - - 2,2 (cociocooroserw);   

 . (cocrocooroscp)

Subject: Inspection Date

  
 
  
 

    

. 

 

Good Morning

  

r,_ceived your voice-mail messae reardin the upco DSATIAPHIS inspection of the to be registered to our

[3254 Division for work at the The Division has requested the inspection be held on Thursday,
March 11, if at all possible.

 

      

Thank you in advance for your consideration of this request.

Sincerely.
"i 14 

 

2
Accession Number: Specia191714 Page: 1141 Sean Date: 2014-09?17 COPY

 

U.S.C. 262301:

 

 

 

3
Accession NUmber: Specia191714 Page: 1142 Scan Date: 2014?09?17 COPY

 

 

[b.2153 DCIOPH PRIDSAT)

 

 

 
   

 

     
 
 

 

From: mum (cocxocooxosem

Sent: Monday, March 01. 2010 10:Laura R. - I: - {cocxocooxosspx
the: 

Subject: RE: Inspection Date 

 

 

Thank ou for the confirmation. We'll plan on meetin in the Bui ding Lobby area at 10:00 on Thursday, March 11.
3' 

Sincerely,

 

USO. 2523111:

 

 

 

 

 

From: CDCICOTPERKDSAT)

March 1, 2010 10:31 AM

 
  
 

 

 

 

 

(CDCICOTPERJDSA -- 
Subject: RE: Inspection Date

 

Yes, 10:00 AM on March 11. Thank you.

 

 

 

 

1
Accession Number: Specia191714 Page: 1143 Sean Date: 2014-09-17 COPY

http: I 

This datument is intended for the exclusive use of the recipient{s} na ed above. It may contain sensitive information that is protected,
privileged, or con?dential, and It should not be disseminated, distribd d, or copied to persons not authorized to receive such information. If
you are not the intended recipient{s}, any dissemination, distribution; or copying is strictly prohibited. If you think you have received this
document In error, please notify the sender immediately and destroy the originai. Thank you.

 

From:  (cociocoorosem

Sent: Monda Marc 01, 2010 10:16 AM
room? oi (cocrcorpenroser)  
Cc: 33-"1 LbiffgiijP-S-C- 35' 

fl?) (CTR)
Subject: FW: e232 Inspection Date

 
    

 
  
 

 

 

 

 

 

 

 



Have you received confirmation that March 11'? will be the date for our inspection of the suite in Building to be
registered to our ?133-342 Division?

   

Thank you in advance for your assistance with this request.

Sincerely,

 

U.S.C. 2623ch-

 

 

 

 

 

 

From: 3 i (CDCIOCOOIOSEP)
Sent: Monday, Feb'jy 22, 2010 12:19 PM


 

To: ?Ii-61 ?ibis: in; CDCICOTPERIDSAT)
Cc: [by-5i ?33533, CDCICCIDINCIRD)
Subject: RE: 3552-20,; Inspection Date

 

 

 

 

 

 

Thank you, we?ll look forward to hearing from you Soon.
Sincerely.

ioii3;::42 0.3.0.5
252mm

Centers for Disease Control and Prevention

 

 

 

 

2
Accession Number: Specia191714 Page: 1144 Sean Date: 2014?09?17 COPY

Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22
Atlanta, GA 30333

 

USC. 252mb}

 

 

 

 

 

 

From: ibis; 
Sent: Monda Fe iary 22, 2010 11:02 AM
To: 9523.343  (CDCIOCOOIOSEP)
Subject: RE: sass

 

 

 

 

 

Inspection Date

 

 

I believe we can accommodate March 11. I will confirm this data within a couple of days. Thank you.

 

 Eb)[62: [:bjii?l 


Division of Sellect Agents and Toxins
Centers for Disease Control and Prevention
Of?ce of Public Health Preparedness and Response (OPHPR)
1600 Clifton Road MS A46
Atlanta. GA 30333

[bli?l

 

 

 

 

 

httn: 1' fwvselectaeentseov

This document ls intended for the exclusive use of the recipientts} named a ove. It may contain sensitive information that is protected,
privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If
you are not the intended recipientis}, any dissemination, distribution, or co ying is strictly prohibited. If you think you have received this
document in error, please notify the sender immediately and destroy the or ginal. Thank you.

 

 

 

From: (cocrocooioscm

Sent: Monda February 22, 2010 8:23 AM
To: (cocicorpewosm)
cc: Zamt R. 13* 

we . (cociocooiosem
Subject: Inspection Date

 
 

. (sociocoolosem;

  

 

 

 

 

 

 

Good Morning - 

 

    

I received your voice-mail messae reardin the upco inspection of the to be registered to our
Division for work at the The Division has requested the inspection be held on Thursday.
March 11, if at all possible.

3
Accession Number: Specia191714 Page: 1145 Sean Date: 2014-09-17 COPY

 

Thank you in advance for your consideration of this request;

Sincerely,

 
 

 

[51433342 I iuyi3iz42 use. 252mm I
2

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

ijbj1L3j1142 use. 252301;;

 

 

 

4
Accession Number: Specia191714 Page: 1146 Scan Date: 2014?09?17 COPY

 

inns: I.

From: 

 

   

 

 

Sent: 23, 2010 3:Subject: RE: CDC Inspection

Way to go!

 

U.S.C. 252a[h}

 

 

 

SRA International, Inc.

Contractor for the CDC for the Division of Select Agents and Toxips
1600 Clifton Road, NE MS A-46

Atlanta. GA 30333

 

$132242 USE. 252mm

 

 

 




. . . .

   

Enhancing human health around the world, every day.

Please consider the environment before printing this e-mail This electronic message transmission contains information
from ERA international, Inc. which may be confidential, privileged or proprietarv. The information is intended for the use
of the individual or entity named above. I

(CDCIOPHPRIDSAT) 
{cocxoPHPR/osm} (CTR)

 



From: Wevant, Rob 
Sent: Tuesday, March 23, 2010 37:59 AM
To: m, 
CC: 

Subject: RE: CDC Inspection

 

U.S.C. 2523

 

 

 

I also received a complementary report on - 3" 33

 

performancg from  ?305? the Building lab manager.

 

1
Accession Number: Specia191714 Page: 1147 Sean Date: 2014-09-17 COPY

Rob Weyant

Robbin S. Wevant, 

Captain, USPHS

Director, Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Office phone: 404-218-2001

Cell phone: 678-614-2234

SiprNet: jsatzDQ@iricp.dia.smil.mil

DSAT Vision: To be the preeminent resource for the safety End security of biological agents and toxins.
Message--~--
use. 252a.;hj: 

Sent: Monda March 22, 2010 4:27 PM


i= 
Subject: FW: CDC Inspection

Please see below for your information and actions, if so 

 

  
     

 



 

SRA continues to provide a high level of support and it is trlily appreciated.

Sincerely,

 

 



 

 

 


1600 Clifton Road, MS A46
Atlanta, GA. 30333

 

Ph:
BB Cell {has}
Fax:

Website: 


 

 

 


From: {cocroernrosnr}
Sent: Monday, March 22, 2010 9:52 AM

 

 

2
Accession Nomber: Specia191714 Page: 1148 Scan Date: 2014?09?17 COPY

 

From: 

Sent: Thursday, March 13, 2010 4:14 PM


Cc: 

Subject: CDC Inspection

 

 

 

I wanted to take a moment to praise the performance of - 3'3 3? on the recent inspection on which she served as
Lead Inspector. I do this not as an member of the entity but as previous lead inspector that respects the work of a
colleague. You, Jim, and I know very well the stresses involved ip inspection such as this, particularly for contract staff. I
was particularly impressed by her competence and composure during the exit debrief which she attended alone with
the USDA inspector that did not say one word.

Ijust thought that I would share this with you.

Thank you,

Sent from my BlackBerry Wireless Handheld

E. Ph. D.

Biosafety Officer

Lead Occupational Health and Safety Manager
Office of Health and Safety

Centers for Disease Control and Prevention
1600 Clifton Road, MS F05

Atlanta, GA 30333

Office: 404.639.3238

Ce?:

cuv4@cdc.gov

This document is intended for the exclusive use of the recipient?s} named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intenqed any dissemination, distribution, or
copying is strictly prohibited. If you think you have received thi; doCument in error, please notify the sender
immediately and destroy the original. Thank you. 

3
Accession Number: Specia191714 Page: 1149 Sean Date: 2014-09?17

COPY

 

 

 

I into: PWDSAT) 

 

 

 

 

From 

Sent: Tuesda Se temoer21, 201012346 PM

To:  
Subject RE: SAinspection  

 

  

case since he has had previous access and has provided training for that space. it is just a refresher for
Buildinghich should be provided by the program prior to inspection. However. for building he has never had
access or training or entered the tabs while they are hot. full training as described will be required. We just cannot deviate
from that which am sure he can appreciate.

Thanks

 

it];
[3:14
2 

 

 

 

 

 

  

mire: I 

 

  
  

    
 
 

-- it??


(cocrocoorosnsi; 

 

   

(CD
(CDCIOIDINCZVED)
Subject: RE: SA inspectionl [bier-i2uscmein: 

 

 

lbjl33242 U.S.C. 
2523th}

(ENE)

 

 

. . . . 
rbzr?: wall be the only DSAT requesting entry into the laboratories. He last entered the U-S-C- @252
laboratories for the October 2008 inspection. He has inspected the laboratories prior to them being

operational.

     
 

 

 

[bll?l

 

 

 

Division of Seiect Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS Ill-46
GA smart

 

[bjtl?i

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents,
hosts. and vectors of human disease to protect the public health in the united States.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

1
Accession Number: Specia191714 Page: 1150 Sean Date: 2014-09-17 COPY

 

   
  

    

          

 

 

 
  
 
  

Swim 3 CDCIOPHPRIDSAT)
J-  - Hq-prs? [libero

cc. U.S.C. 3-:
I -.

eel-42 (coprocoorosrrs);  muse: 


RE: SA inspection I u.s.c.?252ain: 

 

  

 

    

 

Any person entering the high containment labs. iiviil be required to view the OHS training video and have a
walk through by OHS of the outer corridorichecklist. Once that is complete the person should be escorted by a program
speci?c trainer and introduced to the practices and proceduiies of entry and exit of that space. The program at this point
must make the call regarding their training and sign off. This is program SA space and they control who goes in and out.
Once signed off by program they can enter the space for the inspection but obviously they would have to be escorted by
an approved user at all times.

has provided a training form on tine for the  Sections 5, II and should be completed prior to the
inspection process. I do not want the inspection process tc'be the ?rst entry or introduction of entry and exit procedures
for the inspectoris). So some advanced scheduting for traidlng would be required.

 

Thanks

 

[$113342 U.S.C. 2523ih]

 

 

 

Office of Health and Safety

Centers for Disease Control and Prevention
1600 Clifton Road

Atlanta. GA 30333

 

U)

ib::L3}242 U.S.C. 2623ih}

 

 

 

 

 

 
 
  
   

  
  

-. - rocoorosrle);

- . 
(CD ti? ma (cocrocoorosas);
(CDCIOIDINCZVED)

Subject: RE: SA inspection I rbj:r3j::42 

    
     





I  

 

 

 

 

 

Thank you for the information you and have provided.

will bring documentation ofl accine witi'iin 3 years. The safety manuals for the user groups will

be provided prior to the inspection for to review.

Please clarify what training is required by OHS for inspectioi?i of the laboratories, and whether it will be provided at
the time of inspection or need to be scheduled in advance.

Thank you,

2
Accession Number: Specia191714 Page: 1151 Sean Date: 2014-09-17 COPY

 

[bifth

 

 

 

ivlslon of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road NE MS A46

it"?l A 

 

[b?i?i

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents,
hosts. and vectors of human disease to protect the public health in the qnited States.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It mayr contain sensitive information that is proteeled. privileged. pr con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

 

 



  
  

  
 
 

      

Sent: Th tember 16, 2010 9:57 1 
To;-  - '3 - CDCIOPHPRIDSAT)
Cc; i  M342

 



Subject: RE: SA inspectionl 

 

We  

 

Thank you for the additional input.

Sincerely,

 

Iib;::13;::42 I use. gauze I
it r? 9 in:

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. lvlail Stop ilk-22

Atlanta, GA 30333

 

[mega??i2 use. 252%:

 

 

 

 

 

  . (cociocooioSHE)
Sent: Thur dav. Se' tember 16. 2010 9:Accession Number: Specia191714 Page: 1152 Sean Date: 2014-09-17 COPY

..-

 



Subject: RE: SA inspection I 

 

To add toafetv comments below. Entering anvhot laboratory in the basement will require site
specific training. ese would be the same as menti?ned for 15. So in keeping with requirements for
entering an active lab in andi'or manle knowledge training video checked tour by OHS 
accompanied by a approved user after having being remain! of the rules and features in case of problems)

 

Also there is vaccination requirement for enteringl more use. 252m That is any space shared with the program
will require vaccination every 3 years.

 

 

 

 
   

Thanks
From: Imi??i?: 5- 
Se 1-. - ember 16, 2010 9:41 AM

  
 

(CDCIOPHPRIDSAT) 
We?? 48:42
  {cncromrw - -  

 

       
 

     

    


Subject: FW: SA inspectionl 

 

 

 

 

(3000] Morning [use

Please see e-mail below from regarding the? pro-entry requirements for the Us;

our entity.

 

 

registered locations at

Sincerely,

 

[0133242 U.S.C. 262301} I

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

[0}[3342 U30. 252mb}

 

 

 

 

 

From: use; 
Sent: Thursda SeptembEr 16, 2010 9:29 AM
To:  
Cc:j    - {cocroIorchvEm
Subject: SA inspection requirements

 

   

 

 

4
Accession Number: Specia191714 Page: 1153 Sean Date: 2014-09-17 COPY

 

inks:- (CDCIOPH PRIDSAT)

 

 

 

 

  

   
  
 

 

 

 

From: 
Sent: Thursda October 28, 2010 3:93 PM
To: I [cocroPHngosnTJ 
cc; We? 1   
Subject: Notification of Facility Project


 

 

 

 

The purpose of this correspondence is notify DSAT of a schedule work project for our Building - 3 3 . Vivarium. The
project is set to commence in early November 2010 and should He completed by January 29, 2010. Please see
attachment for scope of work. No animal holding areas will be cupied during the duration of the project. Work will not
begin until auch time as the Office of Health. Safety and Environment (OSHE) has decontaminated the space. OSHE
decontamination activities are scheduled to begin on Monday. Ngvember 1. 2010.

 

[bjlf3ji42 U30. 2623
[hi

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

 

[0:133:42 U.S.C. 262mb}

 

 

 

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Accession Number: Specia191714 Page: 1157 Sean Date: 2014-09?17 COPY

 

P2009453 HVAC Modi?cations to Building aircrew-sc-wam: I

The existing Building Vivarium consists of eight Holding Rooms, each of which has an
associated Procedure Room. The Vivarium also Ftwo additional Procedure Rooms, a
WW . and support spaces, including a dirty cage staging area, and showering and
gowning roOms. The Holding Rooms are arranged  two rows of four separated by a common
I [brief Iln?lu?g?ati?'? a I The current air balance relationship is such that the Procedure Rooms
dive to a Clean Corridor, Holding Rooms  negative to the Procedure Rooms, and the

,.?2a2arn; is negative t0 {1'16 Holding RODITIS.

 

 

 

       

use: 5-2525:

 

 

[bit33242 U.S.C. 252301]

The scope of this project will alter the air ?ow arrangement such a .
 will be made positive; therefore, no long?: be called a but a ?grey?
Corridor. Therefore, the Holding Rooms will be negative to both its associated Procedure Room,
and the new ?grey? Corridor. The imrovement will eliminate the collective mixing of Holding
Room air in the existing 'ibil'33142U-S-C-Emmi

  

    

 

The scope of work to accomplish this modi?cation ncludes partial removal of exhaust air in the
dirty cage staging area, adding supply air in the exigting dirty corridor (new ?grey? corridor), and
rebalancing all rooms as necessary. Architectural mpdi?cations include removin existing door

which separates existing Clean Corridor from the existing and the
opening will be ?lled with concrete masonry and a hew window. A new concrete masonry wall
will be installed to separate the new ?grey? corridor-from the existing dirty cage staging area. A
new ?ber reinforced polyester (FRP) door will be installed in this wall.

  
 

Accession Number: Specia191714 Page: 1158 Sean Date: 2014?09?17 COPY

 

I ?it I 

From: icocxopHPism}

 

Sent: - uary 23, 2011.752 AM
To: I I 
Subject: in building 

 

 

 

 

 


. . . .. - - 

Sent: Tue I. 1:42:23 20 
Subject: Re: in building if}

 

 

  

Yes. I did not get a chance to come talk to you today before my ?ight sent a photo of sheep housing in New

  ad or Australia and said they wiil use the same in 13. 'rle stated everyone would wear PAPR's in the suite when
work is active. He also has the entire suite at than just the animal housing room. I will bring the
photo and  we:  comrnent5 by when I return Thursday. 

 
    
 

 

 

 
  

  
 

.  Iwith the justifies  is strain has been
worked with a [bm?usm nd ?g?g?gamgc' as asked them to
{3 to Show the 252m: did no prom ed these data. and

denied their request. I have prepared a letter for Centers requesting the same data.

  

i'b"il3'; [blitz-4.2 U.S.C. 252aihibj:i3j::42 use. 252mm

    

   
   

 

 

 

 

 

 

 

 

 
   

(CDCIOPHPRIDSAT)
(CDCIOPHPRIDSAT)
Sent: Tue Fe :04:32 2011
Subject: in building

Has there been any word from CDC about the proposedwork in sheep in building .

 

1
Accession Number: Specia191714 Page: 1159 Sean Date: 2014-09?17 COPY

 

 

[bli?i PRIDSAT) i!

From: 

 

Sent: Frida .June 05. 2009 3:25 PM
To: 
Subject: Requesting facility review for genters

  

for centers. Centers submitted an amendment to add space {Building

[strain-w u.s.c.?2s2aih; for gro-p_ Biosafety level . - for work with

This space was inspected in Octi'Nov 2008 and the inspect report has been closed out. To my knowledge. 3
am It}; revievv has not been done. This amendment is on the old forms. have copied original letter. Section 5's. and floor
plans and placed them in your mailbox.

   

   

       

 

Please give this review precedence overl $133142U-S-C-s252ath3 I

 

Entity; I ib;i3;:42 use. 252mb.- I
Folder:
Amendment 

 

Thank vou

 

ibii?l

 

 

 

SRFA International, Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road. NE. MS A46

All ?ll 

 

fbll?l

 

 

 



This document is intended for the exclusive use of the recipienttq) named above. It may contain sensitive information that
is protected. privileged. or confidential. and it should not be diss 'minated. distributed. or copied to persons not authorized
to receive such information. If you are not the intended recipient?s]. any dissemination. distribution. or copying is strictly
prohibited. If you think you have received this document in erroii. please notify the sender immediately and destroy the
original. Thank you. -

1
Accession Number: Specia191714 Page: 1160 Scan Date: 2014-09?17 COPY

 

 

tans:   

 

 

 

 

 

 

From: ?311133 (CTR)
Sent: Thursday, June 2009 2:00 

Tu:  (CTR)
Subject: Technical amendment for your. approval
Hello Susan,

      

I nters Amendment U-Sfb-i: 25 0 data entry today. It atlas 2 suites of rooms in Buildingforoup and
Eeagiit' I I These rooms were inspected in OcUNov 2008, anqthe inspection has been closed out. Security review is
said the amendment can be approved with the facility review pending.

 

[bjit?jz

 

 

SRA lnternationai, Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road. NE, MS tit-46

Allan-Inn ill"!- 

 

[hits]

 

 

 



This document is intended for the exclusive use of the recipientla} named above. It may contain sensitive information that
is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If?you are not the intended recipient any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in error- please notify the sender immediately and destroy the

original. Thank you. 

1
Accession Number: Specia191714 Page: 1161 Sean Date: 2014-09-17 COPY

 

 

 

ibi-i?} (CDCIOPHPRIDSAT)

 

  

 

I
From: {cm}
Sent: Tuesay, eptemer 15. 2009 +40 PM
TO: [013142 
Subject: Update and requests

 

I'm sorry I missed you today.

 

1) Renovation of the anteroom for 

message said sliht chang I 
use? 26 Will this be for Building .  
and what changes are being made?

 

 

 

  

   

?oor plan will be made during renovation of the anteroom for sis
252 Can you describe where the anteroom is located on the floor an

 

 

Please send a letter stating what renovation work is being done. how the agents will be secured during the renovation,
whether work will be done with the agents while the renovation is: occurring, and provide estimated dates for the start and
completion of the renovation.

When the renovation work is finished. please submit a letter stating that renovations are complete, detail any changes
from the original plan (if any). testify that agents are accounted far and secure. and submit an updated floor plan.

  

[b33142 . i- .-
2) Amendment usi?c. 2 adding Pl U43 "2523

 

 

Section 63, Question 3 is missing the maximum quantity of
information sheet listing agents and max quantity to include

[mm U30 252m Please update the supplemental

 

 

 

 

Section 5 for in this amendment includes onlyi ias PI in the header. Please resubmit
Section 5 with all three PI names included in the header. If it will be helpful, I can send a blank Section 5 that provides 2
lines for PI names. 

 

 

 

3) Amendment Egg-ht; addingz foreign visitors.

 

internally, we will inactivate the two individuals being added on this amendment {rather than withdrawing the amendment)
to facilitate adding them to your registration in the future. No is required on your part. I just wanted you to be aware
you will not receive a withdrawal letter for this amendment. 

4) Amendment 3.35:? addina '2

 

 

 

   

?szarni' 

 

 

 

 

As of 9f14i09, our records show paperwork has not been received by ?319142 USO-WNW Please ensure paperwork is
submitted to CJIS for this individual.

 

I'm also attaching an updated summary of outstanding amendmepts. Please call with any questions or concerns.
-
Wm

Elstan din g_Center.


 

1
Accession Number: Specia191714 Page: 1162 Scan Date: 2014-09?17 COPY

ibif?i

 

SRA International, Inc.

Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE, MS A46

Atlanta GA 

ibii?l

 

 

 

 



This document is intended for the exclusive use of the named above. It may contain sensitive information that
is protected. privileged, or confidential. and it should not be ?isseminated, distributed or copied to persons not authorized
to receive such information. If you are not the intended recibientijs), anv dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in Error, please notify the sender immediater and destroy the
original. Thank you.

2
Accession Number: Specia191714 Page: 1163 Sean Date: 2014-09?17 COPY

 

013031 (CDCIOPHPRIDSAT)

 

 

 



 

 

 

 

From: ibii?} 
Sent: uesuoy. January 12. 2010 2:4? PM

To: (?33142 
Subject: RE: Renovation Completed

Thank you ??33 i?

 

 

ibii?:

 

 

SRA International. Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road. NE. MS A-4S

30333
in;;L3;::42 use. 262aih';


This document is intended for the exclusive use of the named above. It may contain sensitive information that

is protected. privileged, or confidential. and it should not be disseminated. distributed. or copied to persons not authorized
to receive such information. If you are not the intended recipienll?l. any dissemination. distribution. or copying is strictly
prohibited. If you think you have received this document in error. please notify the sender immediater and destroy the
original. Thank you.

 

 

 

 

   
     
 

 

From: lib? 

Sent: Tuesda Janus 12. 2010 2:16 PM

To: cocrco'rpsarosmrr'rm .

Cc:   IW mmUSO-Wat?: 
lair-'12 (cocrocoorossp) 

 

 

Subject: Renovation Completed

Per your email request of Septemb.=[ . 2009. find attached a letter of con?rmation that the
renovation project scheduled for PI. mill ?0?53 mime USE-math: laboratory in Building has now been completed.

 

 

 

Also attached. please find a copy of the updated ?oor plan for the renovated laboratory.

 

File:Renovation Completion Ltr-01122010.pdf File: 
Respectfully submitted.

252 Floorplan-D1 122010.pp1 

 

 

Centers for Disease Control and Prevention

Of?ce of Security and Emergency Preparedness
Personnel Suitability and Select Agent Compliance Br
1600 Clifton Road. NE. Mail Stop A-22

Atlanta, GA 30333

 

use. 252mm:

 

 

 

5-..- as
1

Accession NUmber: Specia191714 Page: 1164 Sean Date: 2014?09-17 COPY

OSEP Customer Satisfaction Survev.

This document is intended For the exclusive use of the reeipien?s} named above.  mag,r contain sensitive information that is proteeted, privileged, or con?dential, and
it should not be disseminaled, distributed, or copied to persons not authorized to r?eive such information. if you are not the intended reeipient{s), any dissemination,
tiistribtllitm1 or copying is Slrielly prohibited. If you think you have received this iibcumenl in error, pieaso notify the sender immedialel'y and destroy the original.

2
Accession Number: Specia191714 Page: 1165 Sean Date: 2014-09?17 COPY

 

 

 

CDCIOPHPRIDSAT)

 

 

 

 

 

 

I
From: (CTR)
Sent: Wednesday, February 2010 3:10 PM
To: M3142 
Subject: RE:

 

I'm sorry about the delay in getting back to you. May I call tomorrow to discuss this?

imis:

 

 

SRA International, Inc.
Contractor of the CDC for the Select Agent Program

1600 Clifton Road, NE, MS A-46
ran some

 

USE. 252600:

 

 

 



This document is intended for the exclusive use of the recipient{s} named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient(s), any dissemination. distribution. or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the
original. Thank you.

 

 

 

From: than: (CDCIOCOOIOSEP)
Sent: Wednesda February 2010 8:20 AM
To: (CTR)
Sub-1e 

Good Morning 

 

 

I hope you had a restful weekend. I just wanter: to Icheck back you to see if there has been a decision et as to
whether or not we can maintain the Buildi [m ?32. registered to the Special Pathogens Branch at and also
register it for Enhanced used by th [3:54 Division for  work during periods when the Special Pathogens Branch
is not actively using the suite? As mentioned to you previously, the laboratory space would be roerly decontaminated

between uses by the two "owners", and personnel from the one tparn would not have access to the area

while work from the other team was ongoing.

 

 

 

We look forward to a decision from DSAT for this request.

Sincerely,

 

uscg al

Hg 5' HT
Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop 
Atlanta. GA 30333

I [mill-:42 U.S.C. 252200} I

 

 

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Accession Number: Specia191714 Page: 1166 Sean Date: 2014-09?17 COPY

 

ibzziez: I 

 

 

 

 

 

 

II
From: 
Sent: Thursday, April 22, 2010 4:0? EM

To: libii?} I libii?i I
Subject: Centers March 2010 inspection report

 

Centers sent in responses to their inadequate for the March 2019 inspection. Included were updates for the Building
manual removing the vaccinia immunization requirement for the outer hallway. I have requested that ?3334 send in
a statement that this update is included in the manual. (See ins?ection folder notes.) When you receive this information
from her. please add it to the responses and review for the adequate letter. Please also ensure a copy of the at law:

letter goes to APHIS with the information that this concerns the $102010 Centers inspection and Amendment gig-gs

 

 

 

 





 

 

SRA International, inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE. MS A46

(131 
[hii?i



This document is intended for the exclusive use of the recipientlg} named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipient 5). any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in errony please notify the sender immediater and destroy the
original. Thank you. 

 

 

 

1
Accession Number: Specia191714 Page: 1167 Sean Date: 2014-09?17 COPY

 

 

 

 

ib?~i?l 

From: {cocxopHPIt/DSAT) (CTR)
Sent: Friday. May 07. 2010 3:32 PM
To: 

   

Subject: RE: Request Regarding Annual Maintenance: il- i? Laboratory

Thank you for this information Yes. you may defer the filter verification to allow for the completion of the
current experiment in progress. 

 

 

 

SRA International, Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road. NE. MS A445

Atlar?a Ch an?m?:

 

ibifi?l'

 

 

 



This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that
is protected. privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized
to receive such information. It you are not the intended recipientls). any dissemination. distribution. or copying is strictly
prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

 

 

-  (cocrocoorossp)
Senlt:Frida Ma 0? 20101139 AM

To; .: (CTR) 
.. [stasis-hiss 

 
  
  
 

 

 

taboratory

For our telephone conversation. please see confirmation from Dr. I   OHS. regarding the status of the
exhaust HEPA ?lter for the animal holding room associated with our Laboratory. I'll look fonivard to
hearing back from you regarding whether or not our request for permission to continue the current mouse protocol through
July 2 will be authOrized by DSAT.

 

Sincerely.

 

 pI [b13342 usc. 252mm I

Centers for Disease Control and Prevention
Select Agent Compliance. Roybat Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

USE. 262301}

 

 

 

1
Accession Number: Specia191714 Page: 1168 Sean Date: 2014-09-17 COPY

 

ingot?12 0.30. 252arh;

 

 

 

 

 

From: (CDCIOCOOIOHS)
Sent: Frida Ma 07, 2010 11:01 AM

.  - (CDCIOCOOKOSEP)
Cc: Howard, William (Bill) 
Subject: RE: Request Regarding Annual Maintenance:

  

 

    
 

.3l 53

CDCIOCUOIOHS)
:36. 25 Laboratory

 

i can verify that the pressure differential across the HEPA in room currently within the acceptable range.

   

Thank you,
 I Ph. D.
Biosafety Officer

Lead occupational Health and Safety Manager
Office of Health and Safety

Centers for Disease Control and Prevention
1600 Clifton Road, MS F05

Atlanta, GA 30333
Offic=: 404.639.3238
Cell: ibli?:
cuv4@cdc.gov

 

 

 

 

This document is intended for the exclusive use of the recipibnus) named above. It may contain sensitive information that
is protected, privileged, or confidentiai, and it should not be Elisserninated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recibiends}, any dissemination. distribution, or copying is strictly
prohibited. If you think you have received this document in Error, please notify the sender immediately and destroy the
original. Thank you.

 

 
 

To:
Subject: RE: Request Regarding Annual Maintenance: i 

 

 

Yes. Please verify that the pressure differential across the filter is currently within parameters that you deem
acceptable.

 



 

 

 

SRA International, Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE. MS Fir-46

2
Accession Number: Speeia191714 Page: 1169 Sean Date: 2014-09?17 COPY

Atlanta :39 some

 

fbii?:

 

 

 



This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that
is protected. privileged, or confidential, and it should not be disseminated. distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipientts), anyr dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the

original. Thank you.

 

 

From: I?bis'??gtf lib-23,342  
06, 2010 12:5? PM

 
  
  

 

 

  

. ..
-  
U.S.C. 2?2a[h:  

 

Subject: Request Regarding Annual Maintenance: i? Laboratory

 

Good Afternoon 'ibiit?i

 

 

 

 
   
 

       

 

Our . i 3252 Suite, currently has active work ongoing. The HEPA housing
servicing the ace associated with the mi??  laboratan is scheduled for ckfrecertification in May

  

 

 

2010. Since the ?339142 . Lab has an ongoing mouse protocol in heir ?3135342 Room s2a2am: that is not scheduled for
completion until July 2, would it be possible for us to be granted permission to continue with the use of this space for the
protocol at ?33314 and be granted an extension (of approximater 36 days) in which to schedule the annual HEPA
housing checkfrecertification? It should be noted that the mice are contained in a HEPA-?ltered micro-isolator equipped
with multiple HEPA ?lters. Thank you in advance for your consideration of this request.

 

 

 

Respectfully submitted.

 

thj:t3;:42 use. 252ath:

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

[0:181:42 USE. 252mm

 

 

 

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Accession Number: Specia191714 Page: 1170 Sean Date: 2014-09-17 COPY

 



 

 

From: leis: 
Sent: Wednesoay, august 11, 2010 1:53 PM

 

 

 

  

 

To: lib-13:42 (cocxocoorOSEPi
Subject: FW:Bidg IWaIk~Through

 

 

 

 

[bir??

 

 

 

[1?11 

SRA International, Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE. MS xii-46



 

[bll?l

 

 

 



This document is intended for the exclusive use of the recipientts) named above. It may contain sensitive information that
is protected, privileged. or confidential. and it should not be disse inated, distributed or copied to persons not authorized
to receive such information. If you are not the intended recipientls}. any dissemination, distribution, or copying is strictly
prohibited If you think you have received this document in error* please notify the sender immediately and destroy the
original. Thank you.

 

 

From: rm: ?mi-e 
Sent: Frida July 15, 2010 5:39 PM
-   (cocrocoorosep)
DSAT (CDCIOPHPRIDSAT)

 
    

 

 

Looks good to me. Please thank everyone for their cooperation.

Imus} ?tetra:  Eff! I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta Genreia Qn'l'l

 

 

{Ulla}

 

 

 

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

 

 

  

From: [513142 - ?3 
Sent: Friday Jul 16, 2010 5:10 PM

 

  

 

 

 

  

  
 

 

TO: I (CDCIOPHPRIDSA ICOO OSEPH 


1
Accession Number: Specia191714 Page: 1171 Sean Date: 2014-09-17 COPY

?3

 

(coerciomczve. - (CTR)
Subject: Walk-Through

 

 

 

Please find attached a list of attendees at this afternoon's ?Elk-through of the Building I 0138142USE-Heath: I Suites in
the currently registered to Pl teamiThe pur ose of this walk-through was verification of
and security measures to expand utilization of the 

I. sace to include use at 
for virus work in addition to tha current registered purpose

 

 

 

 

 

 

As discussed the ?3:61:42 lwill work on a written planlchecklist for
submission to DSAT to document the steps that will be takdh each time we transition use of the space between
and   I use. We plan to submit the tvritten plani'checklist to DSAT within the next 2 weeks. Items
to be included in the planlchecklist will include ensuring for Bhysical and electronic inability to open doors between active
and rooms in the facility decontar?ination procedures between uses, as well as description of
work flow, waste stream and insurance that studies will be to the appropriate safety level for the agent in use at
the time. Let me know if I have missed anything we discus?ted during your visit.

 

   

File: Evita: lof Review of Roybalh 

Thank you, again, for your time this afternoon in review of tit locations in the 

Sincerely,

 

 

?1:133:42 U30. 2623ih}

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop 

Atlanta GA 30333

inj;i;3;::42 use. 252mm

 

 

 

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Accession Number: Specia191714 Page: 1172 Sean Date: 2014-09?17 COPY

 

[cli?l 

From: immense

  

 

Sent: Friday. August 20. 2010 10:36 AM

1-0: ?313142 ?33334 - (CDCIOCOOIOSEW

Subject: RE: Walk-Through
Thank you - 3' i?

 

 

ibiit?iz

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

AALAA

 

icii?';

 

 

 

We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors
of human disease to protect the public health in the United States.

Please consider the environment before printing this e-mail. This document is intended for the exclusive use of the recipient named
above. It may contain sensitive information that is protected. privileged. pr con?dential. and it should not be disseminated. distributed. or
copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination. distribution. or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the
original. Thank you.

 

 

From: Ilibj:f3j::42 I
Sent: Fridav Au ust 20. 2010 9:51 AM

2- (coc(CDFIOCOOIOSEP)

 

 

 

Please see attached for a copy of the written plan and checklist.

 

Fi e: I use. 252mm 
Respectfully submitted.

 

 

I .:bj:i;3j;:42 use. 2522mm 

 

Centers for Disease Control and Prevention
Select Agent Compliance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

[bjf3ji42 USE. 

 

 

 

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Accession NUmber: Specia191714 Page: 1173 Sean Date: 2014?09-17 COPY

 

Ema?; 10:13:42 use. 25291111:

 

 

 

 

 

From: '10::13j242 ?10:13:42 I (CTR)

 

 

 

Have you sent the written planlchecklist referred to below?

 

 

SRA International. Inc.
Contractor of the CDC for the Select Agent Program
1600 Clifton Road, NE MS 111-46

Alla-unla- f??h 

 

[bitl?l

 

 

 

..

This document is intended for the exclusive use of the recipientls) named above. It may contain sensitive information that
is protected, privileged, or confidential, and it should not be Bisseminated. distributed. or copied to persons not authorized
to receive such information. if you are not the intended recibientts). any dissemination, distribution, or copying is strictly
prohibited. If you think you have received this document in larror. please notify the sender immediately and destroy the
original. Thank you.

 

 

From: 1  (cocrOPHPRiosm
Sent: Friday, July 16, 2010 5:39 PM
. . I
Cc: lie-5': Martha (cocromparosnr)
subject: RE: B dg lb} 111113142 u.s.c.?25201n1 Wa k-Thr-Ough

 

 

 

i
Looks good to me. Please thank everyone for their cooperation.

libirt?i: I Ilbiit?'; I 2I

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46

Atlanta. Georgia 0.09.?

 

 

[b16142 U.S.C. 

 

 

 

DSAT Vision: To be the preeminent resource for the safety ahd security of biological agents and toxins.

 

  
  

 2?2: (cociocooiosep)
Jul 16, 2010 5:10 PM

(morocco/0H5);  

   

To: - 3: 
Cc:

 

 
 

 

[0:133:32 I
2
Accession Number: Specia191714 Page: 1174 Sean Date: 2014-09?17 COPY

 
 
 
 

. -  i=
M33342  
use. EBZaihj: elk-Through I


.
Subject: 

 
    

 

 

Please find attached a list of attendees at this afternoon's walk-through of the Buildin 
the currently registered to PI, team. The purpose of this walk-th rough was verification of

laborat and security measures to expand utilization of thel U-S-C- 252W ls ace to include use at
- - for virus work in addition to the current registered purpose

 

  
 

 

 

 

 

 

As discussed the I ?ill-31342 U-S-C- Iwill work on a written plantchecklist for
submission to DSAT to document the steps that will be taken each time we transition use of the space between
and use. We plan to submit the written plani'checklist to DSAT within the next 2 weeks. items
to be included in the planlchecklist will include ensuring for physical and electronic inability to open doors between active
and rooms in the facility decontamination procedures between uses. as well as description of
work flow. waste stream and insurance that studies will be restricted to the appropriate safety level for the agent in use at
the time. Let me know if I have missed anything we discussed during your visit.

  

 

  

File: lof Review of Roybal Building 3 3 
Thank you, again, for your time this afternoon in review of thel locations in the 

 

Sincerely.

[b38142 use. EBEalh}

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1500 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

?3:131:42 U.S.C. 2523111}

 

 

 

3
Accession Number: Specia191714 Page: 1175 Sean Date: 2014-09-17 COPY

 

i (CDCIOPHPRIDSAU


From: 

Sent: ober 13. 2010 [3:09 PM

To: -  53 [bit-3:342 

cc: libitlriztz I i. I 1 3:
I 31?: 

Subject: RE: Training for Inspectiop Team Members

 

  

   

rcocrocooxosu?i


  
   

 

 

 

.ing Monday morning and won't be available until We are also planning an openin
office Monday morning. Could we schedu'e the inspectors training for 9AM and for

9:30?

Where we will report to for training?

 

 



 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta. GA 30333

ibii?}

 

 

 

 



DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiotogicat agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. if you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. if you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

 

- - . . . 
Sent: Tuesda October 12, 2010 6:46 AM
To: the? cocrocoorOSHE); [as 

Cc:   rulings 


Subject: RE: Training for Inspection Team Members

 

  

 

This is fine by mew-where do the inspectors need to go to attend the training? I'll defer to  as to whether or not
starting at 8:00 am will present any conflicts for the inspectors. Thank you again to you and - 31"? or your assistance in
this training effort.

 

Sincerely.

[b13142 Nib}
Iiisc 5.9 a Il3li42U

Centers for Disease Control and Prevention

 

1
Accession Number: Specia191714 Page: 1176 Sean Date: 2014-09-17 COPY

 

Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

 

[013:242 USE. 252mm

 

 

 

 

  
    

00:10;r OSHE)

      
  

 

. 12. 2010 6:14 AM I .
To 33514333342 
Cc: err-1:42 mire-?12 (cocromniczveo); ii=-  - - - WI

 

(cocropurtiossT)
Subject: RE: Training for Inspection Team Members

How does training on October at 3 am work for Each video will last approximately 30-35 minutes. There will
be two videos. one for and one for

   
 

Just to be clear. the flu labs in 
down for annual maintenance thus the wr

wilt not be hot during the DSAT inspection. They are currently
to enter, only program escort.

 

Thanks

  

 

cociocoorOSHE)
.  

 

   

We'll need 8 inspectors to go thru the training.

 

[bits]

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

Atlanta GA 30333

 

[bjrtEj

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select ad?nts and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this email.

2
Accession Nomber: Specia191714 Page: 1177 Scan Date: 2014?09?17 COPY

 

 


er 2010 12:52 PM
tencrorarivossr);   cocrocoorosnsi


 

 

    

 

 

 

 

(cocron-inrosn)
Subject: RE: Training for Inspection Team Members

 

. . . . . . . . . . . .
Theivisron laboratories in the would be included in the training requirement area as well.

 

U.S.C. 2E2aih'.?

 

 

 

Centers for Disease Control and Prevention
Select Agent Compiiance. Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta. GA 30333

 

U.S.C. 262aih:

 

 

 

 

 

From 
Sent: Thursday. October 2010 12:32 PM
To: seam  
 


Subject: RE: Training for Inspection Team Members

 

 

 

 

  
 

- 
. 

 

 

   

 

 

   

The 6 inspectors are made up of the teams that will inspect non space for and SP3 As long
as there are no additional Pl's with registered space on the basement level of or the total will be 8.

 

tbtt?:

 

 

 

 

[bjzij??-

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

antes
(ENE)

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public heatih in the United States.

 

 

This document is intended for the exclusive use ofthe recipient named above. it may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. lfyou are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original. 

Please consider the environment before printing this email.

 

 

From: - (cocrocoorosris)
Sent: Thursda . October 2010 12:03 PM
To:   

   

(CPCJOPHPRIDSAT)

3
Accession Number: Specia191714 Page: 1178 Sean Date: 2014-09-17 COPY

  

- i 
(cocropHpiuossT)
Subject: Re: Training for Inspection Team Members



 

 

MCL basement lab and basement labs only.

Thanks

 

 
 
 
 

Fro; I -- 

To:. 

CC: - - 3: 3? 
the:  (cocioPHPRipsAT)
Sent: Thu Oct 0? 11:56:53? 2010 -..
Subject: RE: Training for Inspection Team Members

 

 

 

defer to i   - as to whether the space is included or it this is just for the space.

Sincerely.

 

I USC. 2B2ail'ii: I

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus

1500 CIlftUi?l Road. NE. Mail Stop A-22
Atlanta. GA 30333

 

U.S.C. 252mm

 

 

 

 

mtcocxoa?ipwosm

- - -  
Ilmi'?i 
Subject: RE:  Training for Inspection Team Members

 
    

 

 

 

 

i understand this training will be for only spaohs for the group - in?: I
acourate. a total of inseotors will need this training. Pleabe let me know if you are requiring this training for
spaces outside of and i will update the number.

Please note the walk thru of HVAC facilities for and proposed for Oct 18 will need to start after this training
is compieted.

Inspectors will be able to complete this training on the of October 18.

 

4
Accession Number: Specia191714 Page: 1179 Sean Date: 2014?09?17 COPY

 

ibll?l?

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS 

Atlanta. GA 30333

 

{bud}

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation ofetiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive infon'natlon that is protected. privileged. or con?dential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. if you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. If you think you have received this document in error. please notin the sender immediately and destroy the original.

Please consider the environment before printing this e-mailTo: we: DCIOPHPRIDSAT)

 

(CDCIOCOOIOSHE):

 

(b j: 

 

 

 

OSHE. has reminded us this morning that inspection team members that will be conducting laboratory
inspections in space also need to complete site~specific For Building that includes watching a 35-
minute video as well as program-specific training session. Please indicate the total number of inspectors that will need to
complete the training so we can ensure availability of an a equate training location. Please also confirm (to all on
this correspondence} that inspectors will plan on completing this training on the morning of Monday. October 18.

Sincerely.

 

[b2t?33142

U-S-C- 26 U.S.C. 262a[h;

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Roybal Campus

1600 Clifton Road. NE. Mail Stop A-22
Atlanta. GA 30333

 

[tili32242 USE. 262mm

 

 

 

5
Accession Nomber: Specia191714 Page: 1180 Scan Date: 2014?09?17 COPY

 

 

 

From: EH 
Sent: Friday. November 05, 2010 13:56 PM
To: (cocxoeepwosy)
Subject: Please review email for Centers

   

 - - Please review the following email including the extra sentence I tacked on at the end. - 3i 3 . . have gasketed
doors {as and the Massung lab has doors that form a conjplete seal (like an autoclave submarine door).

 

(bite;

 

 

 

I have realized that we did not ask for exhaust and power failure testing for our registered laboratories during the
renewal inspection {the same testing that we are requesting for he new laboratories in Building 23). DSAT is
asking for this testing as part of your annual re?verification for laboratories. During your 2008 renewal inspection.
annual verification was requested and documentation of OHS inqpection was accepted to satisfy this requirement. have
not previoust communicated this change in DSAT policy to youI As this testing should be performed when no active
work is taking place in the laboratory. we will request that ou revide this data for laboratories in conjunction with
scheduled shut downs. This requirement will not apply to laboratories with gasketed doors.

 

mite}

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A-46

11 in?! 1Q
[bits-5'

DSAT mission: We regulate the possession. use. and transfer of select agents 311d toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

 

 

con?dential. and it should not be disseminated, distributed. or copied to persons uthorized to receive such information. If you are not the intended
recipient, any dissemination, distribution. or copying is strictly prohibited. If you you have received this document in error. please notify the sender
immediately and destroy the original. .-

This document is intended for the exclusive use of the recipient named above. It contain sensitive information that is protected. privileged. or

Please consider the environment before printing this e-mail.

1
Accession Number: Specia191714 Page: 1181 Sean Date: 2014-09-17 COPY

 

 

I  

  
  

 

From: 
Sent: Thursday. November 18. 2010 #149 PM
To: this? 
Subject: FW: Notification of Facility Project



 

As a biosafety expert. i would appreciate if you could look over this work for Centers vivarium and let me know if
you have any concerns.

 

 

 

ibil?i;

 

 

 

Division of Select Agents and Tot-tins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road NE MS A-46
?ights GA 30333

fbll?)

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. if you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

  
 
 
 

mgr-33:42 use. 
- ber 23, 2010 3:03 PM


Imis?g?f 252I
Facility Project

 

 

var-=4? 

 

 

The purpose of this correspondence is notify DSAT of a scheduled work project for our Building ?ii-3?34 Vivarium. The
project is set to commence in early November 2010 and should be completed by January 29. 2010. Please see
attachment for scope of work. No animal holding areas will be occupied during the duration of the project. Work will not
begin until such time as the Office of Health. Safety and Environment (OSHE) has decontaminated the space. OSHE
decontamination activities are scheduled to begin on Monday. November 1. 2010.

 

Project- P200945 

Respectfully submitted.
1

Accession Nomber: Specia191714 Page: 1182 Scan Date: 2014?09?17 COPY

 

U30. 2523ih]

 

Centers for Disease Control and Prevention
Select Agent Compliance, Revbal Campus
1600 Clifton Road. NE, Mail Stop A-22

Atlanta. GA 30333

 

U.S.C. 2523M:

 

 

 

2
Accession Number: Specia191714 Page: 1183 Sean Date: 2014-09?17 COPY

 

[bjni?jz  

From: DCIO PH PWDSATJ

 

Sent: Tuesday. December 14. 2010 12:58 PM
To:  
Subject: RE: [Emergency exits and Manual signatures)

 

 

 

 

I'm actually looking for the annual R0 reviewisign off on the plan. I?m sorry for any misunderstanding. The same applies
to the request for 

i'il be entering final edits tomorrow. Please continue to send any additional information you have.

'l'I

 

 

[bH?i

 

 

 

ibiiEI

 

 

 

Division of Select Agents and Toxins

Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS tit-46

?l-I-anter. f" It 

 

[bli?i

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This docoment is intended for the exclusive use oftne recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. if you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. Ifyou think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

-m i. . .

- 

Saber 14. 2010 12:44 PM
To 112116;: 

Subject: RE: I was: I Emergency exits and Manual signatgres)

 

 

 

 

 

 

is gone for the day. however. when we sign off on the incident response pian we aiso sign off on the biosafety pian.
If you look at page three. it shows that atl individuals signed off on the master acknowledgement sheet that includes all
manuals. I will have to provide you with our office signature at another time.

Emergency routes maps are housed in the incident response plan for Pl's and by elevators and stairwells of CDC
facilities.

 

[13:13:42 U.S.C. 2623111: I Ilib}(3}242 U.S.C. 2523 I


 

Internal Select Agents Program

1600 Clifton Road M15 A22
hilantn (-1.5. 

 

[03:31-12 U.S.C. 2523111:

 

 

 

1
Accession Number: Specia191714 Page: 1184 Sean Date: 2014?09?17 COPY

 

From: 7

Sent: Tuesday, December 14, 2010 11:16 AM 

To: I'3?i3i'33??42 

Subject: RE: (Emergency exits and Manual slbnatures)

[33:t2

Thank you for the information.

  
 

I had requested annual review dates {2009 and?-2010) for the biosafety plan for but received a signed review
page for their incident response plan. Can you provide review dates for the biosafety plan?

You provided a copy of the emergency evacuation routes fof and the ?oor. Can you confirm where
this information is posted within the buildings or that the routes provided are included in the incident response plan?

Thank do.
it 



 

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS lei-46

Atlanta GA 30333

ibii?i

 

 

 

 

DSAT mission: We reguiate the possession, use. and transfer of select agents and toxins and the importation of etiologies! agents. hosts, and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use ofthe recipient named abo?ve. it may contain sensitive information that is protected. privileged. or
confidential. and it should not be disseminated. distributed. or copied to pet'sons not authorized to receive such infon'nation. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. Ifyou think you have received this doCument in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.


ber 14. 2010 10:58 AM


(Emergency exits and Manual signa res)

 

 
 
 
 
 

 


 - [31:42 - -
U30 [his

Internal Select Agents Program
1600 Clifton Road Ma's A22
33

   

 

 

 

 
  

  

U30. 252mm

 

 .2
Accession Number: Specia191714; Page: 1185 Sean Date: 2014-09-17 COPY

 

 

 

 
I

From: coczoenpsyosm)

 

 

 

 

Sent: Wednesday. December 15. 2010 4:46 PM

To: U-S-C- 
Subject: FW: CDC blurb

Attachments: CDC Inspection blurbdocx





262aih?

 

 

 

Please substitute this information for the added paragraph. Please remove the line space between the first sentence of
the second paragraph and the beginning of the bulleted list.

 

tolls}

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1500 Clifton Road NE MS Flt-46
nta GA 30333

{bits}

 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importatlon of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive infom'iation that is protected, privileged. or
con?dential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. if you are not the intended
recipient. any dissemination, distribution. or copying is strictly prohibited. If you you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 



From: 
SeTth-tmd-nasda-v?December 15.. 2010 4:40 PM

To- (his? 

 legs?. .. (CTR)
Subject: RE: CDC blurb

 

 

 

 

Ifb (E 

 

 

Perfect. Go with it! --

 



?Irn;:is: ph

 

[bit?l

 

 

 



 

 

Future] (?3?53 I 

Sent: Wednesday. December 15, 2010 4:35 PM

1
Accession Number: Specia191714 Page: 1186 Sean Date: 2014-09-17 COPY

 

To: (CDCIOPHPRIDSAT)
Subject: CDC blurb

?1 File: CDC Inspection blur edits.docx 

 

ibii?l

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention 
1600 Clifton Road NE MS A46 

Atlanta {2b 1111111

 

fol-[El

 

 

 

USAT mission: We regulate the possession, use, and transfer of select adopts and toxins and the importation of etiological agents, hosts. and vectors of
human disease to protect the public health in the United States. 

This document is intended for the exclusive use of the recipient named abdfii?e. It may contain sensitive information that is protected. privileged, or
confidential. and it should not be disseminated. distributed. or copied to pal'bons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

2
Accession Number: Specia191714 Page: 1187 Sean Date: 2014-09?17 COPY

The results of the comprehensive renewal inspection of the Centers for Disease Control
and Prevention, Roybal Campus, are attached. This 2 week inspection employed 
inspectors (16 DSAT, 1 APHIS) with the participation of 81 CDC personnel. l't entailed a
review of the following: the CDC Select agent rog'ram biosafety and biosecurity
practices and procedures; review of CDC persq?nnel select agent- and site security-
specific training; examination of primary and secondary engineering containment
facilities and infrastructure; and extensive examination of the CDC physical select agent
inventory, and associated tracking use, and intra?entity transfer documentation, both
electronic and hard-copy.

A total of 36 facility departures were observed, and 8 recommendations are proposed.
Please note the following.

I Inventory: An examination of inventory stocks did not find evidence of missing
items; however, problems in accurate documentation and tracking of agents
were observed (Observations 10 14).

0 Security: Interviews with CDC personnel revealed a need for more rigorous
security awareness training and enforcement of controlled access policies and
procedures (Observation 2).

 

- Facilities Use-$31332, Mamas): Some initial and renewal certifications for

biological safety cabinets (BSCs), ventilated caging systems, and HEPA filter

 

  

units for necropsy tables in Ugligii??g areas were not available. A malfunctioning
airflow indicator in the Building vivayium registered space was observed.
Unprotected vacuum lines were observed in laboratory areas. Documentation of
certifications for exhaust HEPA filters for 2009 and 2010 have been requested for
the registered areas in the Building vivarium, gbg?iz?fu's'c'i suite, an -, 
suite; and failure testing of the air handling systems is pending for all
registered areas not contained within Building area (Observations 14-16,

27?32).

   

Accession Nomber: Specia191714 Page: 1188 Scan Date: 2014?09?17 COPY

 

 

 

 

 

 

 

 


From: WEI 
Sent: Thursday, September 22, 2011 6:07 PM
To: I 
Subject: Fw: Notification of Conversion pf Animal Holding Rooms from ?333342 to 

 

 

 

Categories: Blue Category

     

[bil?i

Centers is notifying us that they will swing registered for PI from ?13334 to Do you recommend any follow
up?

 

- -  
Sent: Thursday, September 22, 2011 02:3
T0: $323,343 ml (CDCIOIDINCEZIDM
Cc; passive-C- Ir-sieam 
(cocrommcezm); 13:42 
(cocrowmcezm); I 
Subject: RE: Noti?cation of Conversion of Animal Holding Rooms from M3342 lis?ici'

   

  
  
 

 

  
 
     

 

 

 

 

 

[5133242 U.S.C. 252aih]
i

lib::[33:42 U.S.C. 
252mm:




 

 

 

Yes, that?s will be follow up to this initial notification to DSAT of the intent to convert the space.

Best regards,

 

 

Lbii33142 U30. uses
252: 262aih',?

 

 

 

 

Centers for Disease Control and Prevention

Select Agent Compliance, Rovbal Campus

1600 Clifton Road. NE, Mail Stop A-22
Allantm?A 30333

 

[bluf33242 U30. 262mm

 

 

 

 

 

From:  eigi=4?  ?Ingres, (coclolomcezm)
Sent: Th rsday, I tember 22, 2011 2:29 
i=   we: 

1
Accession Number: Specia191714 Page: 1189 Sean Date: 2014?09?17 COPY

 

 

 

 

   
 
      
 

Cc: mi?

(cocrommcezm); 
Subject: RE: Noti?cation of Conversion of Animal Holding Rooms from - ii *3

 

 

 

 

 

And the attached protocol has to be followed and the tompleted form sent to DSAT.

 

File: I use. 5 252mm I 

 

 

use. 252mm

 

 

 

 

 

 
      
 

 

    

 

    
     

 

  

  

 

 

 

 

 

 

 

 
 

 

 

From: 

Sent: Thursda Setember 22, 2011 2:21 PM

To: mint": 

cc: :[ojl?jrz? ?3:13:42 11:19:35.2 

lib-33142? (CDCIOIDINCEZI. 1' I 

(cocrommcezxo); I i 2525' (cocroIo/Ncezm); Use-? cociommcezm) 

Subject: Noti?cation of Conversion of Animal Holding Roo from ?1334 to

Good Afternoon

We anticipate that (?eggs-?ice ill begin a protocol in the Building lin

Egtgtaseg The purpose of this correspondence is to pr?vide notification of conversion of Rooms  and
. . .

 

 

?2E2arh; cu rrentlv in use for W342 work, over for wo?: at (see attachments).

 

 

USE. 


 

 

 

 

tol [bjzt33::42 File:

of Conversion

 

 

 

 

U.S.C. 262aih',?

 

 

 

Centers for Disease Control and Prevention

2
Accession Number: Specia191714 Page: 1190 Sean Date: 2014?09?17 COPY

Select Agent Compliance, Roybal Campus

1600 Clifton Road. NE. Mail Stop 
Atlanta GA 7.011".

 

?1:13:42 U30. 2523M:

 

 

 

3
Accession Number: Specia191714 Page: 1191 Scan Date: 2014?09?17 COPY

 PRIDSAT)

 

 

 

   

 

From:  - icocxopapwosm}

Sent: Tuesday, October 11, 2011 12:90 PM 

To: 1113-151: 
Subject: Fw: Notification of Conversion of Animal Holding Rooms from (?"3142 to 

 

 

 

Good morning,

 



   

I anticipate rooms nd for P1 will be continue to be operated at during the December

inspection.

 

These rooms were inspected as i "i 
either.

during the Oct 2010 renewal inspection, and no observations were recorded for

 

ibll?l?

 

 

 

 

 



a ,October 11, 2011 10:35 AM
J- - mm
Subject: Fw: Noti?cation of Conversion of Animal Holding Rooms from in?? to 

 
   

Per noti?cation below, please ?nd attached the procedural ChE'CldiSt for conversion oft?nel (ET-133142 I swing
space from - 33342 to The two rooms have now been made ?hot? atand animals have been moved in for
acclimation.

Space Switch 

 

 

Respectfully submitted,


2E2aih3

     

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

fbji33242 U.S.C. 2523111}

 

 

 

1
Accession Number: Specia191714 Page: 1192 Sean Date: 2014-09?17 COPY

 

 

From: rugs-ts;  
Sent: Thursda Se tember 22, 2011 2:21 PM
To: we": (cocrompwosm?)

 

 

 

 

   
       

   

 

   

 

Cc: [bik314.2P-5-0 Im?? EQI 
(CDCIOIDJNCEZID mm? a (?[3542 

 

?3:133:42 U.S.C. 262a


Him (coxommcezm)
or? to ABLS4


Subject: Noti?cation of Conversion of Animal Holding Roon?is from

 

Good Afternoon
We anticipate thatmm . . ill begin a protocol in the Bhilding gloomusg?z?zam} Iin October' The

purpose of this correspondence is to provide notification ot conversion of Roomsl I. currently in use
for ?13334 work, over for work at [see attachments).

Notificatio:
of 

 

Respectfullv submitted,


   

 

I 1113133442 use. 2523111) I

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

 

EDDIE-12 U.S.C. 2523M:

 

 

 

2
Accession Number: Specia191714 Page: 1193 Sean Date: 2014-09?17 COPY

 

 

CDCIOPHPRIDSAT)

   

 

 

 

 

 

 

  
    

From: ?We: 
Sent: Tuesday: October 11. 2011 12:01 PM
To: [bi-?33142 
Subject: RE: Noti?cation of Conversion of Animal Holding Rooms from - 7' "3
Thank you for the notification
-   - -- 
5e I- 
To: 

Subject: FW: Noti?cation of Conversion of Animal Holding Rooms from ?ill-3?? to

Per notification below, please find attached the procedural checklist for conversion ofthel M33342 iswing

 

 

 

space from ?139342 to The two rooms have now been made ?hot? at and animals have been moved in for
acclimation.
File: Space Switch Checklist-10112011.pdf 

 

Respectfully submitted,

 

3 d?dd

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road, NE, Mail Stop A-22
Atlanta GA 30333

 

?3:13:42 U30. 252mb}

 

 

 

 

 

From: Imi=133=43m 
ember 22, 2011 2:21 PM

 

  

 

    
 
 

 

   
         
 

 

To: I'l (cocxopHPwosim
cc: "r it: 
(CD :2 (CDCIOIDINCEZID 

.  - 
Subject: Noti?cation of Conversion of Animal Holding Rooms from ?133342 to

Good Afternoon
1

Accession Number: Specia191714 Page: 1194 Scan Date: 2014-09?17 COPY

 

We anticipate that will begin a protocol in the Building u;t:j:i3::42 use. ?2523il13 in October_ The
purpose of this correspondence is to provide noti?cation of conversic of Rooms we,? use 252mm currently in use
for ?13314 work, over for work at (see attachments).

of Cenversion [b39342 u_s_c_?2szaihj; File:

use. 252mm 

Respectfully submitted,
[mi 

 

 

 

 

 

 

 

      

 

 

[bit3irr42 113032523
in;

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop 

Atlanta, GA 30333

 

U30. 2?2sihi

 

 

 

2

Accession Number: Specia191714 Page: 1195 Sean Date: 2014-09-17 COPY

 

 

 

(CDCIOPH PRIDSAT)

 

 

From: 
Sent: Friday, October 28. 2011 11:13 AM

 

To: ?313342 
Subject: FW: request from Centers to address reportable incidents at meeting Thursday AM

 

 

From: {33; 

Sent: Frida October 2011 11:12 AM

To: '3  (CDCIOIDINCEZID)

Subject: RE: request from Centers to address reportable incidents at meeting Thursday AM

     

I did check his schedule in Outlook and see that he has two appts in the 9-10 AM window next Thursday, so i'm not sure
about his availability. I will talk to him Monday.

 

 

  rages: 262 (cocimtinicczna)

Sent: Friday, October 28, 2011 11:02 AM

To: [his mil-6': (CDCIOPHPFUDSAT)

Cc: .?E'?tfl 

Subject: RE: request from Centers to address reportable incidents at meeting Thursday AM

 

 

 

 

 

 

 

Ihaye sent a meeting invitation to meet with the Operations Group from 10:00-10:30. I look forward to the
discussion.

 

[Milli-12 U.S.C. 2523M:

 

 

 

 

 

From: (CDCIOPHPRIDSAT)

     
 

Sent: Frida October 28, 2011 10:59 AM
To: [bl-53' ?1'35? (CDCIOPHPFUDSAT)
Cc: (CDCJOIDINCEZID)

 

Subject: request from Centers to address reportabe inciden at meeting Thursday AM

1

Accession Number; Specia191714 Page: 1196 Sean Date: 2014-09?17 COPY

 

  
 

 and Iwould like to invite vo to address their users regarding reportable incidents at
their meetin hursday Nov 3 at 10 AM. will include you on the invitation. In light of several recent

incidents. thought it be helpful to'rtavE'a'ooTtTonal guidance and the opportunity to ask questions. The
group includes SP8. and

 

   
 

 

 

If you are unavailable Thursday morning, perhaps this could be addressed during the Dec inspection closing
meeting or another time during this week and the ?u group could be invited to join this meeting.

 

(bite:-

 

 

 

 

 

{bll?i

 

 

 

Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS int-46
ta GA emu

lbjiib'i

 

 

DSAT mission; We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. if you are not the intended

recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

2

- -- PY
Accession Number: Specia191714 Page: 1197 Sean Date. 2014 09 17 CO

 (CDCIOPHPRIDSAT)

 

     
   

 

From: in?? (cocrocoozosem

Sent: Friday, May 01. 2009 4:38 PM I 

To: Weyant, Rob (cm)

Cc: lea;- ?(we rcocrcorpswoswn

Subject: Re: Change of access to '33?l3i?342U-S-052523 for [swine flu)

 

Rob,
Thank you very much for your rapid response and approval of this request.
Kindest regards,

Sent using BlackBerry

mu Original Message 
Frorn: Weyant, Rob 

  
 

 
 

 

{cocrocooxosspgil-l  coc 
CC: this (cocrcorpsarossn rcocrcorpervosm)

Sent: Fri May 01 16:31:44 2009

Subject: RE: Change of access to ~53 for H1N1 {swine flu}

 

 

Your request is approved. Please notify DSAT prior to the reactivation of these rooms for select agent work.
Thanks,
Rob Weyant

Robbin S. Weyant, 

Captain, USPHS

Director, Division of Select Agents and Toxins Coordinating Of?ce for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention 

404-?13-2001



From: {cocxocooxossei
Sent: Friday, May 01 2009 4:25 PM

To: (cocrcoTPER/osm) (cm)
Cc: Weyant, Rob 

Subject: Re: Change of access to 

No select agents are present in Roorrll Iin Building at this time. This rooms will be used only for
non-select agent work, speci?cally work with H1N1 {swine ?u variant}virus. When these rooms wili be used for select

 

for H1N1 (swine flu)

 

[0:131:42 U.S.C. 2523th

 

1
Accession Number: Specia191714 Page: 1198 Sean Date: 2014-09-17 COPY

 

 

 

Sent using BlackBerry

Original Message 

From: I  1 (CTR)

To: [bier-2. *1 (cocxocooxoscpi

Cc: Weyant, Rob 

Sent: Fri May 01 16:12:04 2009

Subject: Change of access to for H1N1 {swine flu}

  

 

  

Thank you!

 

 

International, Inc.
>Contractor of the CDC for the Select Agent Program 1600 Clifton Road,
MS A-d? Atlanta, GA 30333

 

[b?i?i

 

 

 





Wm! {cocxocooxoscpi

SE "luf' Fridnu {11 ?+009. 3:43 PM


Subject: Re:

 

 

 

 

 

 

about the I 2523??: [currently registered to but unoccupied by Special Pathogens for H1N1
[swine flu variant} work? The Flu Division is in need of additionaISpace to meet needs of the current public health
emergency.



Sent using BlackBerry

2

Specia191714 Page: 1199 Sean Date: 2014-09-17 COPY

Accession Number:

 Original Message 

 

Sent: Fri May 01 15:30:18 2009
Subject: RE:

Yes. You're welcome to call when you're through.

International, Inc.
:Contractor of the CDC for the Select Agent Program 1600 Clifton Road,
za-NE. I?v'lS A416 Atlanta. GA 30333 -

  

 



 

 

 


>This document is intended for the exclusive use of the recipientls) named above. It may contain sensitive information
that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive such information. If you are not the intended recipientls), any dissemination, distribution, or
copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. Thank you.

Message-?-
From: [b11342 (cocrocoorosspi

     

Sent using BlackBerry

3
Accession Number: Specia191714 Page: 1200 Sean Date: 2014-09?17 COPY

 

 



 

   

 
 
   

    

 

-
From: [his 
Sent: Friday, August 12, 2011 12:39 PM
To: Weyant, Rob 
Cc: this? 
rcocxopupnxosm)
Subject: Update on Centers  HVAC verification

Dear Dr. Weyant,

  

and I met yesterday and again today to discuss the areas on the CDC registration for which DSAT
has yet to receive information on HVAC verification. We are checking our list multiple times to be sure that we?re
capturing all of the areas of intErest for Buildings Eli-ind We will both be ready to provide a briefing during the
week of August 22-26.

 

have already suggested the morning of Monday, August 22 or Wednesday, August 24, to another registered entity for a
conference call. I will not try to schedule any other conference calls during the week of August 22-26 until I hear back
from you as to whether you think a meeting would take place with CDC personnel during that time period.

Here are some maior ooints that libii?i land I have discussed:

 

[bj:[5j:

 

 

 

 

[bjrij??

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-a?

Atlanta GA amaa

 

[b::[3:2242 U30. 2B2aih',?

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientls} named above. It may contain sensitive information that is protectedypriviiedged, or confidential,
and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientisi, be aware
I .
Acce551on Number: Spec1a191714 Page: 1202 Sean Date: 2014-09?17 COPY

that any discIoSurer copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the originai. Thank you.

2 
Accession Number: Specia191714 Page: 1203 Scan Date: 2014-09?17 COPY

 

 

 
  
 

From: 
Sent: Thursday, December 22. 2011 1:45 PM

   

 

 

 

 

 

To: few: (cocxopHpmosatif I: 
?1331-2 
Cc: Probst, Paul E. (cocxocooxBFoi; Howard, William {Bill} Bowen.

 

Ken (cocxocooxssoy is: - -
Weyant, Rob 
I 
Subject: RE: Vivarium airflow tests

Thank vou for your acknowiedgement of completion of this request for DSAT, and a special thank you to all at the Rovbal
Campus who worked to fulfill the request. 

Warmest wishes for Happy Holidays!

 

 

 

?33.131142 USO. 2528111}

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Rovbal Campus
1600 Clifton Road. NE: Mail Stop lit-22

Atlanta. GA 30333

 

[113133242 U.S.C. 

 

 

 

 

 

From:  lb3=l53  Imil53 
Sent: Thursda December 22, 2011 10:1? AM

      

Tu: (cocrocooxosrtE); mire?r42 Eb?? 


Cc: Probst, Pa . Howard, William (Bill) Bowen, Ken L. (CDCIOCOOIBFO 
lint-6'1 vveyant, Rob 17??


Subject: RE: Vivarium air?ow tests

 

    

 

 

 

 

Dear ?3:13:42 

 

. 1
Accession Number: Specia191714 Page: 1208 Sean Date: 2014-09?17 COPY



The HVAC verification of the select agent registered space at your facility has been successfully completed.
I wouid like to express my very sincere thanks to everyone involved in the extensive work needed to perform and
document these tests. Thank you all very much, and I hope that everyone has a Merry Christmas.

Yours truly,,

 

ibii?'} 

 

 

 

 

Wm Disease Control and Prevention
Office of Public Health Preparedness and Response
Division of Select Agents and Toxins
1600 Clifton Road, MS A46
Atlanta, GA 30333

 

(bl-[Ej-

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named above. It may contain sensitive information that is protected,priviledged, or confidential.
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. if you are not the intended recipientlsi, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this document in error, please
notify the sender im mediater and destroy the original. Thank you.

 

From: (cocrocooioSHE)

Sent: Thursda December 22, 2011 10:03 AM

To: ?11:34 - 

Cc: Probst Paul E. Howard, William (Bill) Lasky, Robert D. 
(CDCIOPHPRIDSAT) -

Subject: Vivarium airflow tests

   

All,

I met with from DSAT earlier this morning to clarify points of observation during the Dec. 20
testing of airflows in the building Vivarium. A floor plan indicating where airflow was monitored and the
directional airflow observed was given to after our meeting.

The plan shows testing was performed at ante room entrances, procedure room entrances, and animal holding
area exits. Also, autoclave area and shower room entrances.

Hope this heips to better inform everyone.

Happy Holidays,

inE}

 

 

 

 

Safety and Occupational Health Manager
Office of Safety. Health and Environment
.CeotersiaLDisease Control and Prevention

[bli?l

 

 

 

2
Accession NUmber: Specia191714 Page: 1209 Sean Date: 2014?09-17 

 

 

  

From: - - - 
Sent: - - - a - 2010 10:53 AM

To: 
Cc: 
Subject: RE: 

 

Thank you, I'm sorry to bother you, but can you tell me whether or not the request for concurrence has been
forwarded from AT to APHIS for this amendment?

Sincerely,

 

inj:[3j::42 use. ZEEalh}

 

 

 

Centers for Disease. Control and Prevention
Select Agent Compliance, Rovbal Campus
- 1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

 

[0:13:42 U30. 252ath

 

 

 

 

 

From:  ?3315? (CTR)
Sent: Tuesday, April 2010 10:55 AM

 

(b38142 u.s.c.
?2s2arh3

 

 

 

 

 

APHIS may send us a request for more information regarding this amendment. As of today, we have not received a
request from them. We will need APHIS concurrence before approving the amendment.

 

ft] 3 ITS 

 

 

 

International, Inc.

Contractor of the CDC for the Select Agent Program
1800 Clifton Fload, NE, MS A-4B

Atlanta Ga, omen

ibit?i

 

 

 



This document is intended for the exclusive use of the recipientis) named above. it may contain sensitive information that
is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipientisl, any dissemination, distribution, or copying is strictly

1
Accession Number: Specia191714 Page: 1210 _Scan Date: 2014-09-17 COPY

prohibited. If you think you have received this document in error, please notifythe sender immediately and destroy the
original. Thank you.

 


6, 2010 12:53 PM

 

 

       

 

 

 

 

 

this?  (coercineprvose I. 
ain-143? {cocrocoorosewNEE-23 (cocrocoorosers);  

 

 

 

Zambuto, Laura? - Katz Jackie'M crororncmo)
Subject:   

 

Afternoon

ibllEI:

 

 


I realize th is out of the office seeking clarification on the status of the Building Egg??
Suite. amendment. Amendment use '2s2a We received a fax from DSAT indicating that no additional
information be necessary for submission to DSAT regarding the inspection of this location. We understand that
approval of the amendment is still pending, however, I would like to clarifyr whether or not we may still anticipate a
separate written inspection report from USDNAPHIS from the March 11. 2010, inspection of this Suite? Thank you in

advance for your assistance with this request.

 

 

 

 

  
  

 

 

 

Sincerely,
[b?i3j::42 U.S.C. 2623
ihj:

 

 

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop #22

Atlanta. GA 30333

 

use. 252mm:

 

 

 

2
Accession Number: Specia191714 Page: 1211 Sean Date: 2014-09?17 COPY

 

   

 

 

 

 

From: ?tilt? 
Sent: Thursday. December 16, 2010 10:50 AM
To: - (cocropapaxoswn
Subject: RE: CDC - Roybal Inspection Report

I really appreciate all the feedback you?ve provided for this report, especially as you've been out of the office.

 

The report is ready to go out. I, and I are waiting for Dr. Weyant to review and give his approval.

 

ibjzt?}

 

 

 

 



 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Ftoad NE MS til?46

Atlanta GA 30333

 

[b HE 

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. beam. and vectors 0f
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipientr any dissemination, distribution. or copying is strictly prohibited. If you think you have received this closument in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this email.

 

 

From:

San Thursd December 16, 2010 10:45 AM
To: mire (CDCIOPHPRIDSAT)
Subject: Re: CDC - Roybal Inspection Report

(CDCIOPHPRIDSAT)

 

 

[b.ri?i:
Thanks for the response. I thought I should ask the question in case it comes up. Again great job on the report!!
Thanks again for your reply,

 

 

 

 

 

 

 

From: ibii?r (CDCIOPHPRIDSAT
To: in: Isl-b:  (cocro 

Sent: Thu Dec 16 10:03:41 2010
Subject: RE: CDC - Roybal Inapection Report

The observations about plan review are that the statement "Plans wilt be reviewed and revised. as necessary, after any
drill or was not present in the manuals. I?m not sure if they are doing this review and we did not see this
specific documentation, which is why I am asking for clarification in the report. I feel the has a very ordered system in
place for performing annual review of the manuals.

1
Accession Number: Specia191714 Page: 1212 Sean Date: 2014-09?17 COPY

 

 

 

I-sat down with - i=3 1* the week after the inspection concluded to do the interview: I have to say that swered
the Questions more completelythan any other i have interviewed. In addition to OSHE inspections. the ibii?l Iot?ce
also conducts annual inspections of the Faboratories and inventory. ?1334 showed me her correspondence with the
inn-3:4 where she reports her findings to the Pie and follows up with their responses. It appears that the has good
communication with the Pie. and she reacted very quickly and decisively in response to the inventory discrepancies we
observed during the inspection.

 

   

  

I feel that the has provided adequate oversight.

 

[0153

 

 

 

Division of Select Agents and Toxins

Office of Public Heatth Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Fload NE MS 

nu J. fin 

 

ibiil?i:

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exciusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

From: (cocrOPHPRiosinT)
Sent: Thursda December 16, 2010 5:5 I 

- this 
Subject: Re: CDC - Roybal Inspection Report

Ftob and

Great job on preparation and review of this reportll

       

Just one question - did you feel that the had provided adequate oversight? Review of plans was sighted several times
along with lack of intra-entity documentation. Do you feel this could be another bullet iin the cover letter? You have the
best feel for this. so I will leave completely up to you. 

Thanks again for all of the hard work on this!!

 

From: 
To: We ant, Rob 
Cc: [bi-?31? 
Sent: Wed Dec 15 18:43:20 2010
Subject: CDC - Roybal Inspection Report

   

 
 (cocrompeiosm

 

Al]:

Attached, please find the customized CDC inspection report, dated 12/ 16X 2010. The report's
cover letter contains additional text summarizing some of the salient observations. Long lists of

. 2
Acce551on Number: Spe01a191714 Page: 1213 Sean Date: 2014-09-17 COPY

names and iong observations made it a challenge to manage the whitespace, but overall, it looks

good.
.B.: The PDF file is searchable, which should facilitate its review and editing.
Let me know if you have questions, suggestions, etc, before final release to the entity.

Thanks, -- Rob

 

 

 

 

P.S.: MAJOR kudos to this; and [bl-[3142U-S-C-mzamx

 

 

 

 

MIA-AW

ibii?l ibii?l

 



Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Fioad. NE, Mail Stop A-46
Atlanta ran some

 

 

 

 

 

 

[bii?i?

 

 

 


USA Vision: To be the preeminent resource for the safety and security of agents and toxins.

This document is intended for the exclusive use of the recipient(s] named above. It may contain sensitive information that
is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized
to receive such information. If you are not the intended recipientls), any dissemination, distribution, or copying is strictly
prohibited. If you think y0u have received this document in error. please notify the sender immediately and destroy the
original. Thank you.

3
Accession Number: Specia191714 Page: 1214 Sean Date: 2014?09?17 COPY

 

From:
Sent:
To:  
Subject: RE: CDC report

 

 

Will do. Thank you 

 

 

 



 

 

Division of Select Agents and Toxins 
Office of Public Health Preparedness and Response Centers for Disease Control and Prevention
1600 Clifton Road NE MS A46 

tlanta GA 30333

 

 

DSAT mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of
etiological agents, hosts, and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It mav contain sensitive information that
is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not
authorized to receive Such information. If you are not the intended recipient, anv dissemination, distribution, or copving
is strictly prohibited. vaou think you have received this document in error, please notify the sender immediately and
destrov the original.

Please consider the environment before printing this e-mail.



 
Senmm? ber 14, 2010 835:1 AM
To: m5: 
Subject: CDC report 

 

 

 

 

 

 



 

 

14. Ithink we need to ask where necropsies will be performed and how they can be sure that the overcrowded BBC is
functioning properly. 

A couple more suggested recommendations:

recommend to CDC that in the future thev consider doing PI-specific drills to test and evaluate the specific plan for
the PI where appropriate.

Recommend that the Occupant Emergency Plan be referenced in the Incident Plan under "procedures to
be followed by em plovees performing rescue or medical duties."
Thanks,

1
Accession Number: Specia191714 Page: 1215 Sean Date: 2014-09?17 COPY

 

Accession Number: Specia191714 Pag?: 1216 Scan Date: 2014-09?17 COPY



 

 

 

 

 

From: this: cocxopHPR/dsriti
Sent: y, December 10, 2010 3:13 PM
To: 
Subject: Centers inspection report
Thank you

 

[biti?i

 

 

 

arr-'1- .-

Division of Select Agents and Toxins

Office of Public Health Preparedness and Flesponse
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta GA 30333

 

ibii?i

 

 

 

DSAT mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected, privileged, or
confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended
recipient, any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this email.

 


Se Fri . December 10; 2010 2:35 PM
To: (coclopi-iplyosnrr)
Subject: Re:Centers inspection report

.
To me, licking fingers is as bad as eating in the lab. I would cite this - maybe under no eating and drinking. She was also
handling inventory records which are potentiallycontaminated. For clutter, I would recommend that they remove some of
the clutter. For the BSC, isn?t there something about ensuring that the BBC is operating effectively, and this would not be
the'case with so much under the BBC. I think this should be a citation. I do not have a BMBL with me. I would make the
a recommendation, although it is hard to judge without seeing. hope this helps.

 

    

 

 

 

ibii?l

 

 

From: (CDCJOPHPRIDSAT)
To: 

Sent: Fri Dec 10:52:08 2010 
Subject: RE: Centers inspection report

 

spoke with This was before she put on gloves to handle the inventory samples. The paperwork she was handling
was the inventory notebook which remains in the lab. 

 

mire;

 

 

 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1
Accession Number: Specia191714 Page: 1217 Sean Date: 2014-09-17 COPY

1600 Clifton Ftoad NE MS 
tlanta. GA 30333

 

013033

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use ofthe recipient named above. It may contain sensitive information that is protested. privileged. or
confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. if you think you have received this document in error, please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

 

From: {coerceiipniosm
Sent: Friday December 10. 2010 10:44 AM
To: the?? El 
Subject: Re:

Did this person have on gloves? If not. why did they not have the appropriate 

 

       

Centers inspection report

 

 

 

 

 

From: ?ii-ii ,(cociopHPRiDSAT)
To: 

Sent: Fri Dec 10 10:40:21 2010

Subject: FW: Centers inspection report

 

[bite]
In addition to the questions I have below -

An wrote as a recommendation: "reinforce standard microbiological practices of not putting anythin in our
mouth when in the laboratory: escort observed licking fingers to turn pages of lab documentation while inside 
rooms". Do you have suggestions for how to word this in the report?

 



 

 

 

 

 

[bli?i

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Fioad NE MS A416

A?oat-1h: an A ?inQ?J?l

 

ibit?i

 

 

 

DSAT mission: We regulate the possession. use. and transfer of seiect agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. if you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this ermaii.

2
Accession Number: Specia191714 Page: 1218 Sean Date: 2014?09?17 COPY

 

From: 

Sent: Frida December 10, 2010 12:07 AM
 this? 

. {33 Centers inspection report

  

   

 

Inspectors noted ?excessive supplies and materials stored preventing adequate cleaning? in and spaces for a
PI. Should this be cited under D4 ?Spaces between benches. cabinets, and equipment should be accessible for cleaning"
or as a recommendation?

 

It was also noted that space was ?overloaded with supplies and a storage shelving unit next to the
necropsy table too crowded?. Should this be cited under D4 "Spaces between benches. cabinets, and equipment should
be accessible for cleaning" or as a recommendation?

-- - - D4 "furniture should be minimized". it was noted ?unable to squeeze between shelving unit and necropsy
table? and ?shelf too large". Is this an appropriate citation?

 

Thanlt you.

 

 

 



 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Fioad NE MS A-46

Atlanta GA 30333

toys:

 

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination,
distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original.

Please consider the environment before printing this e-mail.

Accession Number: Specia191714 Page: 1219 Sean Date: 2014-09-17 COPY

     
  

 

(CDCIOPHPRIDSAT)

From: . 
Sent: Monday, December 13. 2010 12:16 PM
To: {cocxoPHPwossn
Subject: RE: inspection report attached for your review

Thank you for your feedback! I was hoping you would review this report, and I am grateful you did.

#11 is uncertain about the name of the person the samples were received from, she wrote down one name but
thought she remembered another. Neither name was a select agent registered Pi at Centers. I think the name
received was someone who works under a registered PI {who has more direct contact with the lab} rather than the Pl's

 

  
 

name.

Update: 33"? was the name recorded in her notes. A previously worked witwho
was previousi registered for fat were transferred. It appears that the transfer was from lab but
because i was not told

 

ame, we are not comfortable stating this. I would like to leave this citation as it

 

at the time I was there. My concern is that it is in the necropsy room. A functional 880 when using that room is important;
if not crucial. please advise.

 

#15 and 34 - . suite for I spoke withThey will be certifying the sec and other equipment "soon"
prior to beginning work. It's a pause in the use of the suite and they do have plans to re-certify and use the suite in the
near future. i would prefer to just ask for the certifications for this suite.

 

 

The [380s in the 3 3' 3* roomsl Ihave not been certified and the entity stated
the reason is they have not been used yet. I will update this observation to ask them to certify or remove the rooms.

 

#21 24 I see that these items were not cited in the Jan 2009 report which include

labs. I am waiting for
documentation from the entity that this info is in the plans. .

Foot rests will change to recommendation

#33 Will include.

 

ibil?l

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS int-46

Atlanta GA 30333

[bjzt?ji

 

 

 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged. or 
confidential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended

Accession Number: Specia191714 Page: 1220 Sean Date: 2014?09?17 COPY

recipient. any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error, please notify the sender
immediately and destroy the original. .

Please consider the environment before printing this e-rnail.

 

From: (CDCIOPHPRIDSAT)
Sent: Sund Iv Decerr ber 12, 2010 4:36 PM
To: leer 
Subject: RE: inspection report attached for your review

 

 

 

 

[b163-
This is an excellent report. have just a few comments:
it? - I do not think we can require evacuation routes to be posted if they are in the incident response plan. I think they
should be posted. however. Maybe this should be a recommendation that they post them. (It looks like you are still
checking into this]. 

would'be sure to include all inventory citations even if resolved {as you have done).

 

#11 - do we know the name of the Pl who made the transfer you know if they use the BBC that is overloaded with supplies and equipment? Do you know if the inspectors
smoke tested this 880?? woutd have to wonder if an overloaded BSD could safety protect the worker. or is it just used
for storage?? In addition to not being able to decontaminate. C1 describes that the 380 must be properly maintained. I
would question whether an overloaded BBC is properly maintained.

#15 and 34 - BSCs not certified. Are there certified 8505 in the laboratory? If not. the lab would not meet
specifications. We have required other entities to either certify or remove the room from registration until certified.

  

#21-24 - were these for PI .  ..
plan {verbatim statements ut at: there] - but maybe he removed them. If this was Pl
time.

plan. I thought Pl had a copy of the stander ures from the BMBL in his
?1215': I think we cited this last

 

Foot rests - since these are not a requirement. I am not sure this should be a citation. Maybe a recommendation??

#33- maybe ask also. in absence of audible alarms or monitoring, what procedures are in place to alert workers of airflow
disruption?

Thanks,
[biti?i

 

 

From: ma: (CDCIOPHPRIDSAT)
Sent: Fri 12110;?2010 6:49 PM

To: (cocroeHPRrosriT);l this? I


Cc: I?bii?i Weyant, Rob (CDCIUPHPRIDSAT)

Subject: inspection report attached for your review

 

 

 

 

. Hello.

Attached is a copy of the inspection report for your review. Please note only requirementsrobservations and
recommendations are included. the cover letter is omitted.

Some observations have been moved to other Please read through the report to look for
your observations and provide feedback.

. . 2 
Acce531on Number: Spec1a191714 Page: 1221 Scan Date: 2014-09?17 COPY

 

i :i  
The long dashed lines within an observation are to signify line breaks between paragraphs. U-S-C- will correct this In the

final report.

Due to the size, complexity, and number of people involved in this inspection, there are a few items that were not
addressed during the inspection. I have been in contact with the entity this week to follow up with these items. I am still
expecting some informationfdocumentation from them early next week. If received, I will remove the corresponding
observation or add ?no further action required" depending on the circumstances. There are several citations where I am
hopeful of receiving information and being able to remove the citation and have only included a placeholder for the
observation. I will write out these observations next week if required.

If you are in the office, please see me for the checklists and notes you will need to review the report.
Fleminders:

1. I will need all of you to review the report and give me your edits by COB on Tuesday, 12i'14.

2. The following items have been changed on the checklists:

a. Drills and exercises are marked ?yes?. stated that we do not require entities to perform separate
drillsfexercises for each building and as the extensive tabletop exercise clearly covered security and'biosafety
aspects that this meets the requirement (even though there are separate plans. some aspects of plans are the same}.

b. Incident response plan ?procedures to be followed by employees performing rescue or medical duties" was clearty
covered in the Occupant Emergency Plan under Medical Emergencies. I apologize for missing this and asking everyone
search for it. The OEP covers all of campus including us. This was not part of the PI specific pian I asked you to
raview. .

Thank you for your cooperation as we move through the final stages of getting this report completed!

 

?inspection report draft 1.pdf>>

 

 

I ?315:; IIith'rl'E} I 

Division of Select Agents and Toxins
Office of Public Health Preparedness and Ftesponse
Centers for Disease Control and Prevention
1600 Clifton Fioad NE MS A46
tlanta GA 30333

 



 

 

 

DSAT mission: We regulate the possession, use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of human
disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or confidential. and
it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient. any dissemination.
distribution. or copying is strictly prohibited. If you think you have received this dccurnent in errot. please rmtii?tr the sender immediater and destroy the original.

Please consider the environment before printing this email.

Accession Number: Specia191714 Page: 1222 Sean Date: 2014-09-17 COPY

grcocroPi-Ipwosan

From: 
Sent: 21310 5:39 PM

 

 

 

 

 
      
 

[b}[3}242 U.S.C. 2523

 

 

 

 

 

 

Yo: Eh} 
cc: (bll3ii42 U30. 2628101} irnr? rnouno [blf?l 
Subject: RE: [him-i? U-S-C- 

 

 

 

Looks deed to me. Please thank evervone fortheir cooperation.

 



 

 

 

Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

 

imtcocrocoolossp}

  

 

  
 
 

Se 2010 5:use. 262aih} CDCXOCODZOSEP) intro}

 

 

 

 
 

<cstromreczireoi; we -
(cocrotom ism WW U-S-C- 262?rlcociopnseiosm (cm)

Subject: use. 252m} walkmrough

 

 

 

 

 

 

 

 



Pl nd attached a list of walk?through of the Buildin
th currently registered to PI, earn. The 
uboratery safety and security measures to expand utilization of theli ?'30 2528?? space to include use at BSLS.

virus work in addition to the current registered purpose (BSL4).

 

 

 

    

 

 

[b}[3}242 LJ.S.C. 262athl

 

 

 

-..-. IOperations Group will work on a written planfcheokiist for

the steps that will be taken each time we transition use of the space between
ibi'i?i e. We plan to submit the Written planfohecklist to DSAT within the next 2 weeks. items
to as included in he planicheckirst de ensuring tor physioal and electronic inability to open doors between active
more u.s.c.?2s2arm some in the facility decontamination procedures between uses. as well as description of
Wstream and insurance 3 studies will be restricted to the appropriate safety level for the agent in use at
the time. Let me know if i have missed anything we discussed during your visit.

As discussed the 

 

  

 

 

 

 

 

Fiiezl ?Jim-?2 ?SC-?mm IDete of Review of Roybal iilrlinal ibif?i Lr'w es
Thank you, again, for your time this afternoon in review of th ocations in the (reggae-hiss

 

 

 

 

 

 

Sincerely,

 

U.S.C. 252301}

 

 

 

1
Acces31on Number: Specia191714 Page: 1227 Sean Date: 2014-09-17 COPY

Select Agent Compliance, Roybal Campus 
1600 Ciifton Road, NE, Mail Stop 31-22
Atianta. GA 30333

 

[b}u[3}242 USE. 

 

 

 

2
Accession Number: Specia191714 Page: 1228 Scan Date: 2014-09-17 COPY

 

- (CDCIOPHPRIDSAT) 

 

 

From:  

Sent: Thursday, May 03, 2012 2:10 PM

To:  icncropn 

Cc:  icocroeH 
Subject: - RE: Building vivarium

I talked with a few minutes ago on his way downstairs to perform a couple more interviews with CDC
facilities personnel, and he said that he has already spoken with Dr.'Wevant and will be providing him with a written
report. I don?t have all of the information since I have not attended all of the interviews, but I can tell you that the
vivarium rooms performed without airflow reversais today during smoke testing. and I smoked some outer
lab doors at the clean corridor while CDC personnel donned PPE and entered vivarium'rooms from the central corridor.
The CDC personnel opened inner suite doors and held them open for about 15 seconds, then allowed them to close, all
while we smoked the outer doors. There were no reversals of airflow observed at the outer doors. The vivarium doors
had been adjusted after the incident occurred.

[bli?i

 

 

From:  limit: licocrOPHPRiosnT)
Sent: Thursday, May 03, 2012 11:40 AM
To: this (cocropHPRiosnT)
Subject: RE: Building vivarium

 

ibiis: I
Yes, that would be great! I think Drs. Weyant andwould also be interested, but may be planning to
debrief Dr. Wevant.

  

I 252a will be out Mon ?Thurs.

 

Rob is out until next week.

 

 

From: (CDCIOPHPRIDSAT)
Sent: Thursda May 03, 2012 11:36 AM
To: 
Subject: Building vivarium

 

 

[b34333 . .. . . . . . .
Do vou think you, and Iwould like me to debrief you on the vi5it this morning to the

Building

[bii?j

 

 

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A46

1
Accession Number: Specia191714 Page: 1231 Sean Date: 2014-09?17 COPY

Atlanta, GA 30333
Phone: 404-718-2012

 

[0:83:42 U30. 252301}

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientls} named above. it may contain sensitive information that is protectedpriyiledged, or confidential,
and it should not be disseminated. distributed, or copied to persons not authorized to receive with information. if you are not the intended recipient[si, be aware
that any disclosure. copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this document in error. please
notify the sender immediately and destroy the original. Thank you.

2
Accession Number: Specia191714 Page: 1232 Sean Date: 2014-09-17 COPY



   

From: 
Sent: - Wednesday, May 02, 2012 3:31 PM
To: 
Subject: CDC incident

Hi,

- has suggested that accompany the TLR team tomorrow {Thursday} during the interviews of CDC facilities
personnel, and during smoke-testing of doors in the Building Vivarium. This is afollow-up regarding the Building
Vivarium airflow incident during the interagency trainee tour. The interviews will be at 9 am, and the smoke testing is
scheduled for 10 am. Because this is all directly facility related, I do think that it would be a good idea for me to attend,
and that is what I plan to do. Please let me know if that will be a problem.

Thank you,

 

ibhj??

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1500 Clifton Road, N15 A416

Atlanta, GA 30333

 

(0:133:42 USE. 2623[h]

 

 

 

vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the reclpientis] named above. It may contain sensitive information that is or confidential.
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientlsi, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this dowment in error. please
notify the sender immediately and destroy the original. Thank you.

1
Accession Number: Specia191714 Page: 1233 Sean Date: 2014-09-17 COPY

 



   

  

     

From: 
Sent: Thursday, December 22. 2011 10:17 AM 
To: Lasky. Robert D. (cocrocooxosHti; 

CC: Probst. Paul E. tcocxocooxsroi; I. William (Bill) (cocrocooxosnt); Bowen,
Ken L. [cocrocooreFot -  .   [this
Weyant. Rob [bier

 


Subject: "31314  airflow tests

 

 

The HVAC verification ofthe select agent registered space at your facility has been successfully completed.
I would like to express my very sincere thanks to everyone involved in the extensive work needed to perform and
document these tests. Thank you all very much, and I hope that everyone has a Merry Christmas.

Yours truly,

 

tints:

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road. MS A-46

Atlanta. GA 30333

[03153

 

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biofogical agents and toxins.

This document is intended for the exciusive use of the recipientis] named above. It may contain sensitive information that is protectedpriviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientls}, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

 

 

From: this (cocrocooioSHE)
December 22. 2011 10:03 AM

Lasky, Robert D. 

 

1
Accession Number: Specia191714 Page: 1236 Sean Date: 2014-09?17 COPY

 

 from DSAT earlier this morning to clarify points of observation during the Dec. 20
testing of airflows in the building vivarium. A floor plan indicating where airflow was monitored and the
directional airflow observed'was given to after our meeting.

The plan shows testing was performed at ante room entrances, procedure room entrances, and animal holding
area exits. Also, autoclave area and shower room entrances.

Hope this helps to better inform everyone.

Happy Holidays,

twat

safety and Occupational Health Manager
Office of Safety. Health and Environment
Centers for Diseas Control and Prevention

 

 

U.S.C. 262301;:

 

 

 

2
Accession Number: Specia191714 Page: 1237 Scan Date: 2014-09?17 COPY



 

 

From: 
Sent: Tuesday, Decer??er 07} 2010334? PM ME: mm.
To: [him We?? [his

 

 

  
 

 

 

ruins: 
Subject: RE: Centers inspectio

 

My recollection is that this training had to do with the training of animal handling



personnel in the Us. "2523: Bldg. Vivarium. I remember complete records for 2009; and not finding
any similar training for 2010. 1 will be available to go over the information, with the R0 or ARC), if
necessary, in order to nail this down.

 

-- Rob



 

Iona: "ibli(CDCIOPHPRIDSAT)
Sent: Tuesda December 2010 3:13 PM

Tu: (cocro  rosary' ii?

 

CDCIOPHPRIDSAT)

  

Hello inspectors,

Can you clarify for me what this training is? Is it the annual online training certificate you are looking for. or is it something
different {please describe)?

?Animal holding access training forms signedr'docurnented for 2009 but not available for 2010; vivariumled":ilii.? i'  

 

 

I I

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46

Atlanta, GA 30333

 

1
Accession Number: Specia191714 Page: 1281 Sean Date: 2014-09-17 COPY

saoo LI-SO-PIOZ =eneo uses ZBZI =B?ee =qumnn notsseaov

 

tint-3:42 use. 252athj:

 

 

 

If I. 2- age?.
DSAT mission: We regulate the possession. use. and transter of select agents and toxinsg?airid'the importation of etiological agents. hosts. and vectors o!

human disease to protect the public health in the United States. - -.  ..

This document is intended tor the exclusive use of the recipient named above. It may contain sensitive information that is protected. privileged, or
con?dential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-msil.

 

 
 



 

Sent: Tuesda . December 07. 2010 3:45 PM
To: (common
Subject: FW: Centers inspection 

Rob reviewed notes and told me that this is for training speci?c to animal care personnel and is over and above the online
select agent training and that you all used the access roster for names of people that would require training. Do you have
anything you can add?

Thanks!

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS F's-46

Atlanta. GA 30333

(0:1[3342 USE. 252301}

 

 

DSAT mission: We regulate the possession. use. and transfer ofsetect agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this email.

 

 

From: ?ibii3iz42 
Sent: Tuesda ., December 2010 3:13 PM
To: (CDCIO RIDSAT): 
Subject: Centers inspection

  

Hello inspectors.

Can you clarify for me what this training is?? Is it the annual online training certi?cate you are looking for. or is it something
different [please describe)?

access training forms signedfdocumented for 2009 but not available for 2010; vivarium?

 

 

I I

1
Accession Number: Specia191714 Page: 1283 Sean Date: 2014-09-17 COPY

:1 I I II ti.- 
- a '4 -



Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE MS A46
tinntn GA {10133

 

$133242 U.S.C. 2623013

 

 

 

DSAT mission: We regulate the possession. use. and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive intomnetion that is protected. privileged. or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended

recipient. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment belore printing this email.

 i-    

2
Accession Number: Specia191714 Page: 1284 Sean Date: 2014-09-17 COPY

 

Iibli?} I lime:- 

 

 

 

 


From: - -  (cocxoPHPwoswn
Sent: Wednesday, June 27, 2012 3:23 PM
To: I We? {cocroenpezosnn
Subject: Re: power failure

There is a previous GAO report that addressed this. See

 

 

   

From  
Sent: Wednesda June 2012 03:14 PM
To: cocioenperosm

Subject: RE: power failure

 

How or with whom can I confirm that? 

- . . .

From: 
Sent; Wednesda June 27, 2012 2:02 PM
To: 
Subject: Re: power failure

 

 

The power failure occurred before the building was hot I believe.

Thanks for handling this while I a gone

From: . 
Sent: Wednesday, June 2012 01:51 PM
To: [be CDCIOPHPRIDSAT)

Co: was: (cocroPHPRiosnt)
Subject: power failure

 

 

 

 

 

 

The question has come up regarding the power failure that occurred a while back. Was DSAT involved in any
after action analysis?

 

[b3033-

 

 

 

(bi-[I33
Division ofSeiect Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS A416
Atlanta. Git 30333

HIKE:

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. It mav contain sensitive information that is protected, privileged, or con?dential, and it
should not be disseminated. distributed, or copied. If you think vou have received this document in error, please notify the sender immediater and destrov the
original, thank you.

4
Accession Number: Specia191714 Page: 1323 Sean Date: 2014?09?17 COPY

 

I will archive your email and wait for formal letters with accompanying data from each situation later this summer.

Thank you.

 

 

Ewe-?12.  

Mon 2012 12:01 PM
. (coqopnpwosm)
iv .- - 

(CDCIOS 

 
    

 

  

 

 

 

 

 

 

(CDCIOPHPRIDSA
Subject: Facility Inspection Report: VSPB Request for Additional Clari?cation

Good Afternoon

Per the attached additional request for information from the DSAT Facility Inspection Report and subsequent
responses submitted, it appears that DSAT acknowledges that the information being requested will not be
available until either June or 3 months later than our previous response submitted on April 23, 2012. Do i still
need to furnish a written response by May 22 as indicated or is this e-mail suf?cient to indicate that we
acknowledge that information is still pending and will be submitted upon its availability? Please also note that
BFO has provided update that the new cook tank control panel will be installed at the earliest at the end of June
2012 which means the first 3 months of data requested should be available by the beginning of October for the
effluent decontamination system.

 

U.S.C.
?2528ihj

     

File: SPB-DSAT Round 3  insp 2?

Thank you in advance for your assistance in de?ning whether or not an actual written response is due to DSAT on
May 22, 2012 for the vsee request.

 

Sincerely:
. -, 1.. :2 -   lb:
lie_.i3_._42 Ellinoaz Im?

 

U30. 2523lh}

 

 

 

3
Accession Number: Specia191714 Page: 1324 Scan Date: 2014?09?17 COPY

 

 (CDCIOPHPRIDSAT)

 

From: 
Sent: Wednesday, June 2012 2:02 PM

To: . 
Subject: Re: power failure

The power failure occurred before the building was hot I believe.

Thanks for handling this while I a gone

 

From: 
Sent: Wednesday, June 2012 01:51 PM
To: IIEDHBE I I I 

Cc: his? [his is: cocioPHpRiosnt)
Subject: power failure

 

   

 

 

 

 

The question has come up regarding the power failure that occurred a while back. Was DSAT involved in any
after action analysis?

I [bits] I

I (mid: I

Division ofSeiectAgents ono? Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road, NE MS A416

Atlanta, GA 30333

 

 



 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents, hosts,
and vectors of human disease to protect the pubiic health in the United States. 

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or con?dential, and it
should not be disseminated, distributed, or copied. If you think you have received this document in error. please notify the sender immediately and destroy the
original, thank you.


Accession Number: Specia191714 Page: 1325 Sean Date: 2014-09-17 COPY

 

Hm 

 
   

 

 

 

 

 
 

 

From: It! 
Sent: Tuesday. Ma 22 2012 5:tcocropHPR/osan;  - 
Subject: RE: Request for additional information forAmendment use 1' 

 

Rich and I just talked. There are no further questions at this time. We will address the issue during our inspection later
this year.
Thanks and sorry for the delay!

 

   

From:
Sent: Mondw, 2012 6:01 PM
To: (c

Subject: FW: Request for additional information for Amendment use". 3523



   

 

 

I;oj:lf3j::Attached is PI use. 52 protocol for work with bats. Please review and let me know if this Is sufficient.

Thank you,

:3 :42

   

 

 

From: [were it 
Sent: Monday, April 30, 2012 5:59 PM

To:  tattle-1:2  
Cc:l one: elf-51 (CDCIOIDINCEZID)

 

 

 

 

 

 

 

to

 

Please find attached Protocol tt 93132 as requested in your e-mail from earlier this afternoon.

Best regards,

 

I [1:13:42 use. 2s2aihj:

 

Centers for Disease Control and Prevention
Select Agent Compliance, Hoybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta, GA 30333

 

U30. 

 

 

 

Accession Number: Specia191714 Page: 1326 Sean Date: 2014-09?17 COPY

 

  



Subject RE eest for additional information for Amendment

   

Here is the protocol.

From: 
Sent: Monday, April 30, 2012 5:41 PM

To: [mm (cocrommcezm) 
Subject: FW: Request for additional information for Amendment

FYI?please see e-mails below.

 

 

 



5 2I use. 2o2aih; I

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

Atlanta, GA 30333

 

?1:13:42 U30. 252mm

 

 

 

 

 
  
 

 

 

(CDCIOPHPRIDSAT)

Aril 30, 2012 4:04 PM



 

for additional information for Amendment

The information for item 2 was provided for clarification only. An additional response for this item is not required.

From: ?1:324  

 

    

2
Accession Number: Specia191714 Page: 1327 Sean Date: 2014-09?17 COPY

I am not clear on your second item you seeking a restatement to state all nipulations will be
conducted under primary containment to update what was previously submitted by to be in accordance with
what has been provided below?

 

 

 

 

Thank you in advance for your assistance with clarification.

 

 

ibii :42 uses
252nm  

 

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road. NE. Mail Stop A-22

nil-ante: an 
[bit I242 
262101:

 

 

 

 

[03:81:12 U.S.C.

From:

      
  
 

 


2012 3:01 PM

st for additional information for Amendment

 

 

Thank you for the additional information you provided for Amendment DSAT would like to make the follow

additional requests.

 

1. Please provide a copy of approved protocol i1 2381lQuestlon 1).

2. BEAT would like to clarify the requirement in Question 3. Your response states BL4-N [Appendix 
does not specify that animal manipulations shouid be done under primary containment". Please note that 3L4-
(Appendix applies oniy to work with large animals or birds that cannot be maintained in primary
containment and require physical changes to the laboratory facility itself to accommodate this work without the
use of priman containment. Building is not designed to house or perform manipulations of large animals
infected with U.S.C.?252aih} outside of primary containment, as referenced in Appendix 0. {below}.

 

 

 

 

APPENDIX Q. PHYSICAL AND BIOLOGICAL CONTAINMENT FOR RECOMBINANT DNA RESEARCH
INVOLVING ANIMALS

Appendix (1 specifies containment and confinement practices for research involving whole animals, both
those in which the animal's genome has been altered by stable introduction of recombinant DNA, or
DNA derived therefrom, into the germ-line (transgenic animals) and experiments involving viable
recombinant DNA-modified microorganisms tested on whole animals. The appendix applies to animal
research activities with the following modifications:

Appendix 01 snail supersede Appendix [Physicist Containment] when research animals are of a size or
have growth requirements that preclude the use of containment for laboratory animals. Some animals

3
Accession Number: Specia191714 Page: 1328 Sean Date: 2014?09?17 COPY

 

may require other types of containment (see Appendix Footnotes and References for Appendix
0). The animals covered in Appendix are those species normally categorized as animals including but

not limited to cattle, swine, sheep, goats, horses, and poultry.

it is a requirement that all manipulations (in vitro and in vivo} with

   

[0:133:42 C. 252301}

primary containment BLA: below]. Your response does state that you intend to conduct

manipulations of live animals on a down draft table. DSAT would like to clarify that primary containment is a

requirement and not an extra measure.

APPENDIX All procedures within the facility with agents assigned to [bl-[33342 U30- 2523!??

conducted in the Class biological safety cabinet or in Class I or ll biological safety cabinets used in
conjunction with one piece positive pressure personnel suits ventilated by a life-support system.

APHIS has not yet provided concurrence and may ask for additional information regarding this amendment.

ibi~i3l14l~ ii 31
262a[h_

 

 

From: 

    

         

Sent: Fridar A ri106 2012 1:44 PM
To: -  CDCIOPHPRIDSAT
Cc: .  

 

 

 

 

 

Subject: RE: Request for additional information for Amendment

Good Afternoon

Please find attached the USPS responses to your request for additional information for Amendment

e-mail below sent on April 4, 2012.

 


uses
2?2aih':

 

 

 

Please let us know if you need additional clarification regarding this submission.

I hope you have a great weekend!

Best rega rds,

 

 

Ragga I
.. .. -

Centers for Disease Control and Prevention
Select Agent Compliance, Floybal Campus
1600 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333
3351?: 4? 

 

 

 

 

  


262am: :mm:. i .3. 
Sent: Wednesday, April 04, 2012 10:43 AM

Accession Number: Specia191714

(seamless   

Page:

1329 Sean Date:

 

 



252arh?.

 

 

 

2014-09-17

 

as per your

agents must be done under



 lam not clear on your second item you seeking a restatement to state that all manipulations will be
conducted under primary containment to update what was previously submitted by to be in accordance with
what has been provided beiow?

Thank y0u in advance for your assistance with clarification.

 

 

lb} :142 
25 am: 

 

Centers for DiseaseControl and Prevention
Select agent Compliance, Roybal Campus
1600 Clifton Road. NE, Mail Stop tit-22

Atlanta. GA 30333
:42 usos
252m:

 

 

 

 

.(cocropuewDSAT)
30, 2012 3:01 PM


st for additional information for Amendment v.3.cihs252a
I

 

 

 

 

 

 

 

Thank you for the additional information you provided for Amendment DSAT would like to make the follow

additional requests.
1. Please provide a copy of approved protocol at 2381 [Question 

2. DSAT would like to clarify the requirement in Question 3. Your response states BL4-N {Appendix 
does not specify that animai manipulations should be done under primary containment". Please note that 3L4-
(Appendix Q-ll-Dl applies only to work with large animals or birds that cannot be maintained in primary
containment and require physical changes to the laboratory facility itself to accommodate this work without the
use of primary containment. Buiiding is not designed to house or perform manipulations of large animals
infected withl outside of primary containment, as referenced in Appendix [1 {below}.

 

APPENDIX Q. PHYSICAL AND BIOLOGICAL CONTAINMENT FOR RECOMBINANT DNA RESEARCH
INVOLVING 

Appendix 0. specifies containment and confinement practices for research involving whole animals, both
those in which the animal's genome has been altered by stable introduction of recombinant DNA, or
DNA derived therefrom, into the germ?line {transgenic animals} and experiments involving viable
recombinant DNA-modified microorganisms tested on whole animals. The appendix applies to animal
research activities with the following modifications:

3
Accession Number: Specia191714 Page: 1334 Sean Date: 2014?09?17 COPY

Appendix Ct shall supersede Appendix (Physical Containment] when research animals are of a size or
have growth requirements that preclude the use of containment for laboratory animals. Some animals
may require other types of containment (see Appendix Footnotes and References for Appendix
The animals covered in Appendix C1 are those species normally categorized as animals including but
not limited to cattle, swine, sheep, goats, horses, and poultry.

 

It is a requirement that all manipulations {in vitro and in viva) with  tens-.242 U.s.c. 252nm:  must be done under
primary containment BLA: G-ll-D-3-a, below}. Your response does state that you intend to conduct
manipulations of live animals on a down draft table. DSAT would like to clarify that primary containment is a
requirement and not an extra measure.

 

APPENDIX All procedures within the facility with agents assigned to Biosafety Level A are
conducted in the Class biological safety cabinet or in Class I or II biological safety cabinets used in
conjunction with one piece positive pressure personnel suits ventilated by a life-support system.

has not yet provided concurrence and may ask for additional information regarding this amendment.

 

 

 
    

Sent: 
To: see.
Cc: mini: . --
Subject: RE: Request for additional informatio

Gm? Afternoon

 

 

 

 

 

 

Please find attached the VSPB responses to your request for additional information for Amendment as per your
e-mail below sent on April 4-, 2012.

Please let us know if you need additional clari?cation regarding this submission.
i hope you have a great weekend!

Best regards,

 

[bj:[3j::42 I [busy-ta use. a saga I
2 

I Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE, Mail Stop A-22
Atlanta, GA 30333

 

U.S.C. 2?2aih}

 

 

 

4
Accession NUmber: Specia191714 Page: 1335 Sean Date: 2014-09-17 COPY

 

-  (CDCIOPHPFUDSAT)
Sent: Wednesda April 04, 2012 10:43 AM
To: will? -  [mist-13
Subject: Request for additional information for Amendment 

 

 

 

 

 

 

 

[Dyl?y?l?
USE. 2523


 

 

 

 

1. Please provide procedures used for work with hats at ?31334 to include housing, handling, infecting, sample
collection, cage changing, and escaped animals. Please describe training and expertise for work with bats.

r; . .
2. In Section SB, Question 1 for work perfo it is stated thatis the only live virus manipulated and
that genomic material only from the  will be manipulated. It further states that genomic

 

 

  

material will not be used in conjunction with ?permissive? cell lines nor will any attempt be made to "rescue"
the RNAs. Please describe what measures you will use to prevent unintentional generation of flaviviruses at
physical or temporal separation ofpropagation {maximum quantity of 20 - 150 ml roller bottles},
specific cell lines used for propagation].

3. All recombinant work and work with recombinant organisms, including in animals, is required to be
performed in primary containment. Please describe how primary containment will be maintained for this work.

4. NIH Guidelines now require that BCSs discharging exhaust air back into the laboratory be certified every 6
months when used for recombinant work Please provide in writing how you will comply with this
requirement.

Thank you,

 

raj-rs; I  rb1zr?i 

[bli?l

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

1600 Clifton Road NE M8 A46

Allard?! GA 30333

 

[midi

 

 

 

DSAT mission: We regulate the possession. use, and transfer of select agents and toxins and the importation of etiological agents. hosts. and vectors of
human disease to protect the public hearth in the United States.

This document is intended for the exclusive use of the recipient named above. It may contain sensitive information that is protected, privileged, or
con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended
recipient, any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender
immediately and destroy the original.

Please consider the environment before printing this e-mail.

0


Accession Number: Specia191714 Page: 1336 Sean Date: 2014-09-17 COPY

 

I Iihli?} I Iib??] I 

 
  
 

 

      

 

From: 

Sent: Tuesday, May 22, 2012 5:35 PM

To: "his: (CDCXOPHPRIDSAT)

Cc: [We 2 the? (cocropHPR/osen, coc 

Subject: RE: Request for additional information for Amendment 

Hi

Rich and ljust talked. There are no further questions at this time. We will address the issue during our inspection later
this year.

Thanks and sorry for the delay!

 

From: the? (cocioPHPRiosriT)
Sent: Monda ?ril 30 2012 6:01 PM
- -  - (c

Subject: FW: Request for additional information for Amendment

 

    



 

Attached is Pl protocol for work with bats. Please review and let me know if this is sufficient.

Thank you,

 



2012 5:59 PM

To: "3'35? Imi'?i 

Cc:l [we [b.6342
Subject: Fw: Request for additional information for Amendment use. "252a

 

 

 

  

 

 

Good Afternoon 

 

 



Please find attached Protocol a 3,23,? as requested in your e-mail from earlier this afternoon.

 

 

 

Best regards,
. 3133242

 

 

 

 

Ilb3l3ii42 use. a 252mm.

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

 

[03.31242 U.S.C. 2E2aih}

 

 

 

Accession Nomber:ISpecia191714 Page: 1337 Sean Date: 2014?09?17 COPY

 

From: (cociommcezm)
Sent: Monday, April 30, 2012 5:48 PM
To: 

RE: Request for additional information for Amendment Us}; 252

 

Here is the protocol.
From: [bier-=42 . 

Sent: Monay, April so, 2012 5:41 PM
To: (cocrommcezm)

 

 

 

 

 

Subject: FW: Request for additional information for Amendment 1 
El I
FYI?please see e-mails below.

 

I U.S.C. 262aih}

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta. GA 30333

 

ibj:i:3j:.:42 use. 252%)

 

 

 

anhah?u?n?u?n

From: CDCJOPHPRIDSAT)

Sent: Monda Aril 30, 2012 4:04 PM

 
    
   
   

 

 

 

 

 

Ta: film-42 ?353]?  
Cc; . (CDCIOPHPRIDSAT) Ln .d
Subject: RE: Request for additional information for Amendment 

The information for item 2 was provided for clarification only. An additional response for this item is not required.

 

 

From: ?113242 
Sent: Monda Aril 30, 2012 3:20 PM
To: DCIOPHPRIDSAT) 

Subject: RE: Request for additional information for Amendment uses 25

 

 

2
Accession Number: Specia191714 Page: 1338 Sean Date: 2014-09?17 COPY

I am not clear on your second item below??-are you seeking a restatement to state that all manipulations will be
conducted under primary containment to update what was previously submitted by me; to be in accordance with
what has been provided below?

 

 

 

 

Thank you in advance for your assistance with clarification.

Sincerely,
[bif3i142

  

 

 

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1000 Clifton Road, NE, Mail Stop A-22

Atlanta. GA 30333

 

Eb} 


 

 

 

From: . (CDCIOPHPRIDSAT)
Sent: Monda I, Aril 30, 2012 3:01 PM

   

 

 

 

To: .  
Subject: RE: Request for additional infOrmation for Amendment egg-s

 

  

[bjl3i1-12
42

Thank you for the additional information you provided for Amendment LIB-51326
additional requests.

DSAT would like to make the follow

1. Please provide a copy of approved protocol if 2331 (Question 

2. DSAT would like to clarify the requirement in Question 3. Your response states BL4-N {Appendix Q-ll-Di
does not specify that animal manipulations should be done under primary containment?. Please note that BLA-
(Appendix Q-ll-D} applies only to work with large animals or birds that cannot be maintained in primary
containment and require physical changes to the laboratory facility itself to accommodate this work without the
use of primary containment. Building is not designed to house or perform manipulations of large animals
infected withl [b39342U'S'C'?mmi loutside of primary containment, as referenced in Appendix {below}.

APPENDIX Ct. PHYSICAL AND BIOLOGICAL CONTAINMENT FOR RECOMBINANT DNA RESEARCH
INVOLVING ANIMALS

Appendix (1 specifies containment and confinement practices for research involving whole animals, both
those in which the animal's genome has been altered by stable introduction of recombinant DNA, or
DNA derived therefrom, into the germ-line {transgenic animals) and experiments involving viable
recombinant DNA-modified microorganisms tested on whole animals. The appendix applies to animal .
research activities with the following modifications: 

Appendix shall supersede Appendix (5 (Physical Containment) when research animals are of a size or
have growth requirements that preclude the use of containment for laboratory animals. Some animals

3
Accession Nomber: Specia191714 Page: 1339 Sean Date: 2014?09?17 COPY

may require other types of containment [see Appendix Cl-llI-D, Footnotes and References for Appendix
0). The animals covered in Appendix [1 are those species normally categorized as animals including but
not limited to cattle, swine, sheep, goats, horses, and poultry.

 

It is a requirement that all manipulations (in vitro and in vivo] withl the-33142 U-S-C-?2523ihi Imust be done under
primary containment 0L4: G-ll-D-3-a, below}. Your response does state that y0u intend to conduct
manipulations of live animals on a down draft table. DSAT would like to clarify that primary containment is a
requirement and not an extra measure.

APPENDIX All procedures within the facility with agents assigned to Biosafety Level 4 are
conducted in the Class biological safety cabinet or in Class I or II biological safety cabinets used in

conjunction with one piece positive pressure personnel suits ventilated by a life-support system.

APHIS has not yet provided concurrence and may ask for additional information regarding this amendment.



 

mm: iv 
Sent: Fridargop? 5, 2012 1:44 PM

To: In? 


 

 

  

 

 

  

{cocrommcezm}

    

Please find attached the responses to your request for additional information for Amendment as per your
e-mail below sent on April 2012.

Please let us know if you need additional clarification regarding this submission.
I hope you have a great weekend!

Best regards,

 

 

E-



9R9-2rh'1

Centers for Disease Control and Prevention
Select Agent Compliance, Roybal Campus
1600 Clifton Road, NE. Mail Stop A-22

Atlanta, GA 30333

 

 

 

 

 

 

 

 

 

 

 

in 
 
From: ?its? (CDCIOPHPRIDSAT)
Sent: Wednesday, April 34, 2012 10:43 AM

4
Accession Number: Specia191714 Page: 1340 Sean Date: 2014-09?17 COPY



 

 

. Imit?} I littli?l 

 

 

  

 

From: 

Sent: Monday. June 25, 2012 6:4? PM

To: (?3?53 {cocroPHPR/osan

Cc: icocropnemosm)
Subject: CDC facilties data

Hi

Sorry to bother you on your vacation. The issues around Building continue to rise to the forefront. Dr. Weyant has
asked and I to begin compiling documents regarding this situation {see italics below}. A congressional inquiry has
apparently given a deadline ofluly However that refers to their receipt of related documentation. I assume we
need to have our data organized much sooner than that.

"The letter instructs the CDC to produce to the committee by July 6 all documents relating to biosafety incidents since

 

 

2005 in Building lime-=42 use. a: llabs, as well as all e-mails, meeting minutes and other documents relating to
senior o?icials' discussions of safety issues in the building and all documents relating to recommendations or solutions
to safety problems?

Would you have a few minutes to talk tomorrow? If so, can you give me a call?



 

one: I
Division of Select Agents and Toxins
Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS A416
Atlanta, GA 30333

I Scope] I

 

 

 

Mission: We regulate the possession, use, and transfer of select agents and toxins and the importation of etiological agents. hosts.
and vectors of human disease to protect the public health in the United States.

This document is intended for the exclusive use of the recipient named above. it may contain sensitive information that is protected, privilegedr or confidential. and it
should not be disseminated. distributed, or copied. it you think you have received this. document in error. please notify the sender immediately and destroy the
original. thank you.

1
Accession Number: Specia191714 Page: 1341 Sean Date: 2014-09?17 COPY



'l

Weyant. Rob 

 

 


From: Weyant. Rob 
Sent: Wednesday. June 18. 2003 1:32 PM
To:

 

Subject:

 

l've made a few corrections and deleted the information about sealing with tape and requirements.

what you send to

 

Feel free to forward to fter you hear from the other folks. I?ll forward to

 

 

Many thanks.

Rob Weyant

From: Blaine. James (cocrcoTPEwosz)

Sent: Wednesday. June 16. 2006 12:20 PM

Tu: We ant Rob 
Subject: ?1333-1 Laboratory Issue

 

 

The following time line provides activities by DSAT as it applies to the CDC ?3333?  laboratory in building

 

October 4. 2005: DSAT inspected the CDC laboratories in building identi?ed by CDC as space to be used for ?13334 
work. Deficiencies were observed and a report provided to the responsible official on October 5. 2005. CDC responded to
the deficiencies on November 8. 2005. DSAT determined that the CDC responses were adequate and an
acknowledgement letter was sent to CDC on March 1 2006.

 

June 13. 2006: DSAT conducted a re-inspection of the ?133-34  laboratories because of changes made by CDC.
Deficiencies were observed and resolution of previous deficiencies noted in the October 5. 2005 inspection were verified.
Deficiencies were observed and a report provided to CDC on July 24. 2006. CDC responded to the deficiencies on July
31. 2006. DSAT determined that the responses were adequate and sent an acknowledgement letter to CDC on August
11. 2006.

 

May 31. 2007: DSAT received a TheftiLossiRelease report from CDC of a potential exposure in the - 3 3 .  laboratory
due to an air?ow reversal. No illness resulted from the incident but facility issues were identi?ed. CDC instituted corrective
action that involved a temporary adjustment to the air handling system for the it?? . .. laboratories and institution of
engineering modifications to be completed by July 2006. A follow-up inspection to verify the completion of the corrective
action is expected.

Additional Information:

       

No APHIS inspector has inspected the CDC ?313342 laboratory. 3 i 3 the causative organism of . .
an overlap select agent and is therefore regulated by both CDC and APHIS. Representatives of both agencies are not
required for insections of overlap agents. When CDC laboratories that work with USDA-regulated agents. such as highly
pathogenic ?313342 . virus. are inspected. an APHIS inspector is always included on the inspection team.

is

 

James Blaine. 

Deputy Director

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Road. NE MS A416

Atlanta. GA 30333

Tel: (404) Fax: (404)718-2096; Cell: inns:

 

 

 

 

1
Accession Number: Specia191714 Page: 1343 Sean Date: 2014-09-17 COPY

 Weyant, Rob 

 

 

From: Blaine, James 

Sent: Wednesday, June 18, 2003 12:20 PM

To: Weyant, Rob icocrcorpeerosan; this
?33363 (CDCICOTPERIDSAD

Subject: Laboratory Issue

 

The following time line provides activities by DSAT as it applies to the CD .. laboratory in building

  

October 4, 2005: DSAT inspected the CDC laboratories in building identified by CDC as space to be used for 3 3 . .
work. Deficiencies were observed and a report provided to the responsible official on October 5, 2005. CDC responded to
the deficiencies on November 8. 2005. DSAT determined that the CDC responses were adequate and an
acknowledgement letter was sent to CDC on March 2005.

 

June 13. 2005: DSAT conducted a re-inspection of the 3 3 3 .  laboratories because of changes made by CDC.
Deficiencies were observed and resolution of previous de?ciencies noted in the October 5. 2005 inspection were verified.
Deficiencies were observed and a report provided to CDC on July 24. 2005. CDC responded to the deficiencies on July
31, 2005. DSAT determined that the responses were adequate and sent an acknowledgement letter to CDC on August
11. 2005.

 

May 31, 2007: DSAT received a Thefti'LossiRelease report from CDC of a potential exposure in the ?33 3 . . laboratory
due to an air?ow reversal. No illness resulted from the incident but facility issues were identified. CDC instituted corrective
action that involved a temporary adjustment to the air handling system for the ?33334  laboratories and institution of
engineering modifications to be completed by July 2008. A follow-up inspection to verify the completion of the corrective
action is expected.

Additional Information:

   

No inspector has inspected the CDC 3 33- 333 .. laboratory. ?33334  is an overlap select agent and APHIS has the
option of inspecting laboratories with overlap agents. APHIS did not choose to inspect.

The use of tape as a temporary sealant for containment laboratory doors is a standard practice especially when
conducting decontamination procedures.

 

 

I Iis the recommended level for work with ?333 33

James Blaine. 

Deputy Director

Division of Select Agents and Toxins

Centers for Disease Control and Prevention
1500 Clifton Road, NE MS 

Atlanta. GA 30333

Tel: (404] 715-2050; Fax: Cell:

 

 

 

 

1
Accession Number: Specia191714 Page: 1344 Sean Date: 2014-09?17 COPY

Weyant, Rob 

From: Besser, Rich (CDCKOTPERXOD)

Sent: Monday. June 23, 2008 8:29 AM

To: Weyant. Rob (CDCICDTPERIDSAT)
Subject: RE: Heads up: media interest in labs

Thanks. We'll want to share the talking points with CDC OD communications people as well. Some of the messages that
were going around implied that the duct tape was to provide a better seal. This is inconsistent. thought the duct tape
was to discourage movement between the two rooms until a new door was obtained. I assume that Ann?s shop is helping
with these. I expect there will be some follow-up media and Congressional interest on this today.

Richard E. Besser. MD.

Director

Coordinating Of?ce for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention

1500 Clifton Rd. D44)

Atlanta. GA 30333

phone: 

email: rbesser@odc.gov

 

From: Weyant, Rob 
Sent: Monday. June 23, 2008 3:23 AM

To: Besser, Rich 
Subject: RE: Heads up: media interest in labs

We do. We're working on talking points to clarify when we learned about the duct tape, and the rationale for our
response. Bottom line: containment doesn't require the use of air-sealed doors. So long as the doors are
Ie" to allow for decontamination and the directional airflow system is functioning. doors don't need to be air tight in

 

Rob Weyant

From: Basser, Rich (CDCICOTPERIOD)
Sent: Monday, June 23, 2003 8:03 AM
To: Weyant, Rob (CDCICDTPERJDSA

Subject: FW: Heads up: media interest in labs

 

Do we have a role in oversight of this

Richard E. Besser. MD.

Director

Coordinating Of?ce for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention

1600 Clifton Rd. (M5 044)

Atlanta. GA 30333

phone: 

email: rbessgr??g ggy

1
Accession Number: Specia191714 Page: 1345 Sean Date: 2014?09?17 COPY

 

From: Ganand, Donna 
Sent: Friday, June 20, 2008 5:23 PM

To: CDC Executive Leadership Board
Cc: CDC Enterprise Communication Officers
Subject: Heads up: media interest in labs

 

 

 

 

Leader Hot Topic:  lab safety_
>Share: As needed

 

The AJC is expected to run Sunday a story about an incident last year around our  
Building 

 

During a restart of an air handling system that supplies the lab, a door opened which separates two
clean corridors between the lifgi?gaga lab and the animal vivarium. This occurred in the early morning
hours last May 25th. LaboraiOry staff arriving to the lab for work that day noticed the air handling
system not operating properly and the opened door and notified our safety of?ce. 0! mfg!?
abundance of caution. a number of employees were taken to our clinic and tested for yes-@2623 and
monitored for a number of days and everyone was fine.

 

 

 

 

 

 

 

 

The reporter has received information that raises questions about lab safety including the use of duct
tape around a particular door near the lab. The duct tape was placed around the door as part
of decontamination procedures and it was left on the door to enhance seals around the door. as well
as help prohibit entry through the door from the clean corridor. We are moving to replace the door
with a sealed door to make the lab even safer. This lab has passed all necessary inspections on
numerous occasions.

 

The reporter toured the lab and was shown how CDC is in total compliance with all biosafety
standards. However. she has spoken to a number of experts who question the use of the duct tape.
She also contacted USDA to learn more about their role in inspecting the lab as part of the select
agent process; they likely will be contacting us.

She also has a report from an evacuation drill we conducted last December for staff who will occupy
the suites. The drill served its purpose; a number of glitches were discovered and we are or
have corrected them.

The reporter plans to include the issues above in the context of a story she wrote a number of weeks
ago about Building "95. being a state?of-the art $214 million building and the labs not being
opened several years after we said they would open.

 

Donna M. Garland

Director, Office of Enterprise Communication
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS 0114

Atlanta. GA 30333

4046397540

404-639-T095

2
Accession Number: Specia191714 Page: 1346 Sean Date: 2014?09?17 COPY

 Wezant. Rob 

 

 

From: Blaine, James (c ocxcorpenxosm

Sent: Thursday. June 19, 2003 9:33 AM

To: (C (CDCICCTPERIDSAU
cc: Weyant, Rob [bl-?3142 mi? (CTR)

   

Subject: RE: FW:

Do you mean when should we expect a request asking extend the deadline? Yes. I think it is important to con?rm that
everything is on scheduled.

James Blaine, 

Deputy Director

Division of Select Agents and Toxins

Centers for Disease Control and Prevention
1600 Clifton Road. NE MS 

Atlanta. GA 30333

Tel: Fax: (404)718-2096; Cell:

(are:

 

 

 

 

 

 

From: - i=1  (cocrcorpsarosa'r)

Sent: Thursda June 19, 2008 9:30 AM

To: Hell (coercowsnrosm

Cc: Weyant, Rob Blaine, James WW -
Subject: FW: FW:

 

(CDCICOTPERIDSAT) (CTR)

 

Do you think we should ask Elif the promised upgrades will be ready by Jul}.r 2008?

Division of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Rd NE Mailstop A 46



   
 
 

 

 

 

From: Weyant, Rob 
Sent: Thursday, June 19, 2008 6:45 AM

    
 

os - Skinner, Thomas vv. (cocroorosc -
Roebuck, Von (cocroorosq; Blaine, James (cocrcorpsarosar); [bi-"15? (coqcorpsarosar); Him
(CDCICOTPERJDSAT)

Subject: FW: FW:

fyi

 

1
Accession NUmber: Specia191714 Page: 1347 Sean Date: 2014?09-17 COPY

 

[Out of Scope]

 

 

 

 


CC
053139008 03:12 PM Subject FW:

Freeda.

Here are the CDC talking points regarding the previous inspections in our newlab. Let me know if you have any
oblections. I have to get these in to the press folks by COB today.

Rob Weyant

 

 

From: llblii?li- "foils: 
Sent: Wednesday, June 1L6r 2006 1:5? PM

To: _oc;coTPER;osA
Rob 

Subject:

   

Iibj:t32:: . 32?:

 

The following time line provides activities by DSAT as it applies to the CD . laboratory in building

  

October 4. 2005: DSAT inspected the CDC laboratories in building identified by CDC as space to be used for ?13334 
work. De?ciencies were observed and a report provided to the responsible official on October 5, 2005. CDC responded to
the de?ciencies on November 8, 2005. DSAT determined that the CDC responses were adequate and an
acknowledgement letter was sent to CDC on March 17. 2006.

 

June 13, 2006: DSAT conducted a re-inspection of the ?333342  laboratories because of changes made by CDC.
Deficiencies were observed and resolution of previous deficiencies noted in the October 5, 2005 inspection were veri?ed.
De?ciencies were observed and a report provided to CDC on July 24. 2006. CDC responded to the deficiencies on July
31, 2006. DSAT determined that the responses were adequate and sent an acknowledgement letter to CDC on August
11, 2006.

2
Accession Number: Specia191714 Page: 1348 Sean Date: 2014?09?17 COPY

 

. May 31, 200?: DSAT received a TheftlLossl'Release report from CDC of a potential exposure laboratory
clue to an air?ow reversal. No illness resulted from the incident but facility issues were identified. CDC instituted corrective
action that involved a temporary adjustment to the air handling system for the lit-?33??. . laboratories and institution of
engineering modi?cations to be completed by July 2008. A follow-up inspection to verify the completion of the corrective
action is expected.

 

Additional Information:

     

No APHIS inspector has inspected the CDC ?1?33 laboratory. 3" 3 . the causative organism of ?313342 . 
an overlap select agent and is therefore regulated by both CDC and APHIS. Representatives of both agencies are no
required for insections of overlap agents. When CDC laboratories that work with USDA-regulated agents. such as highly
pathogenic . virus, are inspected, an APHIS inspector is always included on the inspection team.

 

 

lrbjirsj:  I

 

'ivision of Select Agents and Toxins
Centers for Disease Control and Prevention
1600 Clifton Road, NE MS A46
Atlanta, GA 30333
I I

  

3
Accession Number: Specia191714 Page: 1349 Scan Date: 2014?09?17 COPY

 

Laboratory Inspection Chronology

in October 4, 2005: DSAT inspected the CDC laboratories in building identi?ed
by CDC as space to be used for work. The purpose of this inspection
was to verify that his new laboratory area met the requirements of the
requirements of 42 CFR 73 and the nationally recognized standards as described
in the Biosafety in Microbiological and Biomedical Laboratories.

 

0 October 5, 2005: A report was provided to the CDC Responsible Of?cial
describing the deficiencies observed at the 10i4i2005 inspection. The
deficiencies identified were related to recordkeeping.

- November 6, 2005: The CDC Responsible Official responded to the de?ciencies
identified by DSAT at the 10i04i2005 inspection.

a March 2006: After determining that the CDC responses were adequate,
DSAT sent a letter notifying the CDC Responsible Official of this determination.
DSAT deemed the CDC responses adequate because they were in accordance
with the requirements of 42 CFR Part 7'3.

 

- June 13. 2006: DSAT conducted a re-inspection of the 9? i - laboratories in
conjunction with the addition of newl [bite-:42USE-Heath: Ispace. Deficiencies
were observed. Resolution of previous deficiencies noted in the October 5. 2005
inspection was veri?ed.

 

- July 24, 2006: A report describing the deficiencies noted at the 06i13i2006
inspection was provided to the CDC Responsible Of?cial.

- July 31. 2006: CDC responded to the deficiencies identified in the DSAT
inspection report.

- August 11. 2006: After determining that the responses were adequate. DSAT
sent a letter notifying the CDC ReSponsible Of?cial of this determination.

a May 31. 2007: DSAT received a TheftiLossiRelease report from CDC.

- This report described a potential exposure in the laboratory due
to an airflow reversal. CDC indicated that no illness resulted from the
incident.

CDC instituted corrective action that involved a temporary adjustment to
the air handling system for the laboratories.

The CDC Responsible Of?cial submitted to DSAT a corrective action plan
that described permanent modifications to address the airflow issue. The
implementation of these permanent engineering modifications is to be
completed by July 2008.

 

DSAT will conduct a follow-up inspection to verify the completion of the
engineering modifications after receiving noti?cation from the CDC Responsible
Of?cial that these permanent modifications have been implemented.

Accession Number: Specia191714 Page: 1350 Sean Date: 2014-09?17 COPY

Additional Information:

 
 
    

No APHIS inspector has ins - - 
causative organism of '3bi?33?42 is an overlap sel
both CDC and APHIS. Representatives of both agencies are not required for

inspections of overlap agents. When CDC laboratories that work with USDA-regulated
agents, such as highly pathogenic - 3 - .. .
inspector is always included on the inspection team.

dby

  
 

Accession Number: Specia191714 Page: 1351 Sean Date: 2014?09?17 COPY

Weyant, Rob 

 

        

 

From: 

Sent: Friday, August 12, 2011 12:33?? I 
- 

Subject: Update on Centers HVAC verification

   

Dear Dr. Weyant,

 

and I met yesterday and again today to discuss the areas on the CDC registration for which DSAT
has yet to receive information on HVAC verification. We are checking our list multiple times to be sure that we're

capturing all of the areas of interest for Buildingsm and We will both be ready to provide a briefing during the
week of August 22?26.

I have already suggested the morning of Monday, August 22 or Wednesday, August 24, to another registered entity for a
conference call. I will not try to schedule any other conference calls during the week of August 22-26 until I hear back
from you as to whether you think a meeting would take place with CDC personnel during that time period.

 

Here are some maior points that Eli-E33?? and I have discussed:

 

[bjt?j

 

 

 

  

hters for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-46

Atlanta, GA 30333

And "1-111"

 



 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This doCument is intended for the exclusive use of the recipientls] named above. It may contain sensnive Information that is protected,priviledged. or con?dential.
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended be aware

1
Accession Number: Specia191714 Page: 1352 Sean Date: 2014-09-17 COPY

that any disclosure, copying, distribution or use of the centents of this document is strictly prohibited If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

2
Accession NUmber: Specia191714 Page: 1353 Scan Date: 2014-09-17 COPY

- Weyant, Rob 

 

    

From: (cocxopHeRxosen
Sent: Thursday, September 03, 2011 3:11 AM
42 

To: Weya nt, Rob 

 

I [bi-e:

Subject: I RE: Checking in

 
 

I have reviewed the AJC article on th f?
pressure after an HVAC restart. I told Ken that the previous test results would be fine if they include both exhaust fan
failure and power failurefrestart. We always have the option of asking questions about the results which are provided.

 

From: Weyant, Rob (CDCIOPHPRIDSAT)

 

 



 

Are you happy with the testing of th  ab, as described below?

Let?s plan on getting all parties together around the end of this month unless all testing has been done and reported to
US.

Thank;

Rob Wevant

 

 

From: limo: ?one: I 
Sent: Thursday, September 08, 2011 ?:16 AMI
To: Wevant. Rob (cocroeHPeroseT); were

rb

 
  
    




 



  

?53' 
Subject: FW: Checking in

 

Good morning,
USE. I .
252W HVAC testing plan.

rSitters for Disease Control and Prevention

Of?ce of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-45

 


Accession Number: Specia191714 Page: 1354 Sean Date: 2014?09?17 COPY

Atlanta, GA SGBSE

 

[bli?i

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document ls intended for the exclusive use ofthe retipientlsi named above. It may contain Sensitive Information that Is protected,prlviledged, or con?dential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such Information. if you are not the intended reolpientis]. be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this doCument In error, please
notify the sender Immediately and destroy the original. Thank you.

 

From: Bowen, Ken L. (CDCIOCOOIBFO)
Sent: Thursda September 08, 2011 6:33 AM
To: (CDCIOPHPRIDSAT)

Cc: Meechan, Paul J. - 3* i?
Subject: RE: Checking in

Bowen, Ken L. 

 

 

What we have found for the power outage test in some cases it is simpler to just turn off the power to the whole building.
We have so many interlocks and safeties build into our new buildings it is harder to create a simulated outage than turn of
the entire building and deal with the issues that this procedure causes.

   
   

When we modified the HVAC system the redundant fans system, we tested this lab just like the criteria
mentioned in the Policy on BMBL 5"1 Ec ition Laboratory Facilities {Secondary Barriers) Standard that was given to us
during our last meeting. OSHE and our of?ce both observed the air ?ow through a magnehelic gauge and certi?ed that
the lab was working before we went hot. We will give a document that certi?es this observation as record of this testing.
We will not retest this area just use our previous observations. Keep in mind the sealed doors were never part of the lab
functioning properly. Our test was performed with normal lab doors where the sealed doors are today and still had proper
directional air flow. These doors were added later as a result of an AJC article.

 

 

We will also be submitting data from the previous project to verify proper air flow for label  

All other labs are scheduled to be tested on September 15, 22, and At the beginning of October we will have a better
picture of where we are.

Thanks,

Ken Bowen

Director for Facilities Engineering Of?ce
404-639-3303 Office

404-639-0499 Fax

 

 

From: his? 
Sent: Friday, September 02, 2011 8:36 AM
To: Bowen, Ken L. (CDCIOCOOIBFO)
Cc: Meechan, Paul J. (CDCIOCOOIOSHE)
Subject: Checking in
2

Accession Number: Specia191714 Page: 1355 Sean Date: 2014?09?17 COPY

I

Dea

[ii 2'

There is a little more information that I wanted to provide you on th 2323" 
rooms to be tested:

HVAC verification testing and the

 

For the power failureirestart test, DSAT is not requiring that any entity actually shut off the normal power and perform
a load switch, because of the disruption this may mean for building occupants as well as the potential hazards to
electrical components during a load switch. if you wish to perform the test as a load switch, that is an option, but the
power failurefpower restart tests could instead be done as a simulation by simultaneously shutting off both the supply
and the exhaust fanls} which serve the laboratory rooms, while monitoring and recording the room differential
pressures or airflow, and then simultaneously turning on the supply and exhaust fans, while monitoring and recording
room airflow or pressure.

   

After our meeting last week, I talked with about Building suite {the one with the pressure-sealed
laboratory doors}, and she showed me which of the doors on the floor plan have been fitted with gaskets. The gasketted
door at the suite entrance to the main open containment space appears to have a series of three doors between it and
the containment boundary, making the possibilit of an air?ow reversal outside of containment via this route very
unlikely. The other gasketted door in room [tsetse is between a room and directly outside of containment. There
are two options for suiti ii "i - - or confirming the facility design to prevent airflow reversal under failure conditions.
One option is to provide the result of a leak test, such as a soap bubble test, of the 3.355322%, gasketted door, confirming

that the door is air tight. The other option is the performance of the HVAC failure scenarios as discussed last Friday.

 

 

 

 

Please let me know when you will have any update on test results or a testing plan. If you have any final test results, you
could email them to me directly if that is convenient.

Thank you,

  

ibli?';
Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A-46

Atlanta. GA 30333

 

fbh??k

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named above. It may contain sensitive information that is protected,priviledged, or confidential,
and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientlsi, be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. If you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

3
Accession Number: Specia191714 Page: 1356 Sean Date: 2014-09-17 COPY

 Werant, Rob 

From: Weyant, Rob 
Sent: Wednesday, September 28, 2011 1:37 PM
To: - - 

  

 

 

Cc: 
Subject: RE: HVAC testing recap

   

   

Nice job. Many thanks. If they can complete their work to our satisfaction by the end of December, I?m OK with this.

Rob Weyant

Robbin S. Weyant, RBP (ABSA)

Captain, USPHS (Rot)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Office phone: 404-718-2001

Cell phone: 678-6l4-7284

SiprNet: 

DSAT Vision: To be the preeminent resource for the safety and security of bioiogicoi agents and toxins.

 

 

From: IW 

Sent: Wednesday, September 28, 2011 11:43 AM
To: mi? 
Cc: Weyant, Rob 
Subject: HVAC testing recap

 

. 

 

Hi.

Thanks to vou,and all the other gentlemen who took the time to meet with me today. Here is a recap of our
conversation:

First we discussed the current status on the HVAC testing for buildings and am not aware that any of these

results have been provided to date to DSAT.
[Outoi Scope]

 

 

 

 

   

Buildin 

For the lab in building suite}, there were initial tests performed when the lab was first brought
online, and witnesses at that time observed that the HVAC system operated as required to maintain secondaryl

1
Accession Number: Specia191714 Page: 1357 Sean Date: 2014?09?17 COPY

containment. The facility Engineers intend to reconstruct the tests which were performed and to write up the
observations which were previously made, and that should be completed within a few weeks.

  



. 1'  2s lab in building use. s25 Suite} is scheduled to be tested next Thursday 10,36, and a report will be provided
to DSAT the following week, providing the testing is successful. For the building vivarium FEE: huite suite
and ?139342 .. uitej, the exhaust fan failure tests have been successfully completed. Power failurefrestart testing for the
vivarium is planned to be performed in December during a maintenance shutdown.

 

 

 

[Out of Scope]

 

 

 

New Reguest

One thing which I did not say during our meetin a but which am requesting now is that DSAT be provided with the

results of the power failurefrestart tests for the mpaces and the results of the exhaust fan failure tests for the

building vivarium spaces. BeCause it was said today that these tests were successful, I would appreciate getting the

results to whittle down the list of remaining items and to be able to demonstrate the total amount of progress made

toward completing this project. I am also requesting that an update be provided to once available, on the Gomez
gait? re5ults even if potential problems are noted, for the same reason.

 



It is inion that a signi?cant effort is being made by registered entity CDC to comply with request to perform

HVAC verification of the registered areas. It is understood that performing these tests, making any
necessary HVAC modifications and then doing subsequent retesting can be very labor intensive and time consuming. I
told you that I thought that the December retesting projection for the building vivarium power failurefrestart would
be accepted by DSAT because other registered entities have been encouraged to perform the tests during maintenance
shutdowns. The use ofannual leave by testing personnel prior to the end of the year and the December holidays could
present problems, however, for meeting this projection. Please consider whether these factors reduce the likelihood of
this timeline being met, and provide either a confirmation or a revised estimate for the building vivarium retesting
date.

2
Accession Number: Specia191714 Page: 1358 Sean Date: 2014-09-17 COPY

1.

It is'probable that the inspection will remain open until this testing has been successfully completed. Please let me know
if anything stated about the testing status in this email is inaccurate.

Yours truly,

 

ibji?l

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS ill-46

Atlanta. GA 30333

 

ibizi?l

 

 

 

DSAT's vision: to be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipientisi named above. it may contain sensitive information that is protectedpriviledged. or confidential,
and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. li?you are not the intended recipientis), be aware
that any disclosure, copying, distribution or use of the contents of this document is strictly prohibited. if you think you have received this document in error, please
notify the sender immediately and destroy the original. Thank you.

3
Accession Number: Specia191714 Page: 1359 Scan Date: 2014-09?17 COPY



Wezant, Rob (CDCIOPHPRIDSAT)

 

 

 

From: M53   
Sent: I Tuesday, December 2011 8:26 AM
To: Weyant, Rob 
Subject: Re: Vivarium airflow tests

 

Sent using Blackberry

 

From: Weyant, Rob (CDCIOPHPRIDSAT)
Sent: Tuesda December 27, 2011 08:19 AM
To: (cocropnparosar)
Subject: FW: Vivarium air?ow tests

Are there any remaining facility verification issues at CDC Roybal?

Rob Weyant

Robbin S. Weyant, 

Captain, USPHS (Rat)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 40-4-1ll 1 8-2001

Cell phone: 678-614-7284

SiprNet: isatz09@iricp.dia.smil.mil

DSAT Vision: To be the preeminent resource for the safety and security of bioiogicoi agents and toxins.

This document is intended for the exclusive use of the recipient(s} named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipientfs), any dissemination, distribution, or copying is strictly prohibited. If you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

From: Bowen, Ken L. 
Sent: Monda December 26, 2011 7:30 PM
 {cocrom-Iparosar); (cocrocoorosuis); 11- 



Paul E. (cocrocoorsFO); Howard, William (Bill) (cocrocoorosne 1 Ir 
was? Weyant, Rob this}
Subject: RE: Vivarium air?ow tests

Thanks for you help too.

 

. - 
- Stigma (cocrompsrosar);
(CDCIOPHPRIDSAT) 

 

        

    

Thanks Again,

I 1
Accession Number: Specia191714 Page: 1360 Sean Date: 2014-09-17 COPY

Ken Bowen
Director for Facilities Engineering Office
404-639-3303 Office

404?639-0499 Fax

 

From: (CDCIOPHPRIDSAT)

Sent: Thursda December 22, 2011 10:17 AM

To: MEWS-C- ii": 


Cc: Probst, Paul E. Howard, William (Bill) Bowen, Ken L. (CDCIOCOOXBFO 
$33,542, Weyant, Rob 


Subject: RE: Vivarium air?ow tests

   

 

 

 

 

 

 
 

[bi 3:255mm  .- VAC veri?cation of the select agent registered space at your has been successfully
completed. I would like to express my very sincere thanks to everyone involved in the extensive work needed
to perform and document these tests. Thank you all very much, and I hope that everyone has a Merry
Christmas. 

Yours truly,



 

 

ibiIB}

 

 

 

Centers for Disease Control and Prevention

Office of Public Health Preparedness and Response
Division of Select Agents and Toxins

1600 Clifton Road, MS A46

Atlanta, GA 30333

 

[bli??

 

 

 

2
Accession Number: Specia191714 Page: 1361 Sean Date: 2014-09-17 COPY

DSilt'T's vision: to be the preeminent resource for the safety and secu rity of biological agents and toxins.

This document is intended for the exclusive use of the named above. It may contain sensitive information that is protected,priviledged, or confidential, and it should
not be disseminated, distributed, or copied to persons not authorized to receive such information. If vou are not the intended recipientls], be aware that any disclosure, copving,
distribution or use of the contents of this document is strictly prohibited. If vou think you have received this document in error, please notifv the sender immediater and
destrov the original. Thank you.

 

 



 
  
  

(cocrocooroSHE)

cember 22, 2011 10:03 AM

-   . 

Cc: Probst, Paul E. Howard, William (Bill) Lasky, Robert D. 


air?ow tests

 

 

All,

 

9 5 from DSAT earlier this morning to clarify points of observation during the
Dec. 20 testing of airflows in the building 'Ebi. vivarium. A ?oor Ian indicating where airflow was
monitored and the directional air?ow observed was given to after our meeting.

 

The plan shows testing was performed at ante room entrances, procedure room entrances. and
animal holding area exits. Also, autoclave area and shower room entrances.

Hope this helps to better inform everyone.
Happy Holidays.

Dwayne Laskyl

Safety and Occupational Health Manager

Office of Safety, Health and Environment

Centers for Disease Control and Prevention

404-639?4973

 

 

{bits}

 

 

3
Accession Number: Specia191714 Page: 1362 Sean Date: 2014-09?17 COPY

Weyant, Rab 

 

 

 

 

From: min-5': 

Sent: Thursday, June 07. 2012 1:38 PM

To: Weyant, Rob 


Subject: Facility assessment of Vivarium

 

Assessment of the
Registered 


Accession Number: Specia191714 Page: 1363 Scan Date: 2014?09?17 COPY

  

Facility Assessment of the Registered Building Vivarium Space

- anc modifications to the Building vivarium meet BMBL criteria foacilities.

- The air?ow reversal incident was transient, and the mechanical problem has been corrected.

anc Modi?cations to Building Vivarium

The Building vivarium is a multi-roorn containment block surrounded by a "clean" [non-containment}
outer corridor. Entrance to the containment suites is ordinarin via each suite?s anteroom from the clean
corridor, and exit is into the inner ?dirty? {containment} corridor. The original airflow design of the vivarium was
for the air to flow from the animal suite holding rooms into the inner corridor. A decision was made in early
2010 to reverse the airflow of the inner corridor so that the air would flow from this corridor into the animal
suite holding rooms. This airflow change was in strict agreement with the BMBL wording: ?The direction
of airflow into the animal facility is inward; animal rooms maintain inward directional airflow compared to
adjoining hallways.?

The original airflow of the inner corridor was also acceptable from a secondary containment perspective,
because air flowed inward from the clean outer corridor into the animal suite anterooms and from there into
the inner corridor. Personnel entering these areas are wearing respiratory protection and are showering prior to
exiting containment. The wording ofthe BMBL on directional airflow does not in general address the various
possible airflow configurations of multi?room containment blocks.

At the time of the original proposal to change the inner corridor airflow, concerns were raised by facility
personnel about a lack of anterooms between the inner corridor and each animal suite. One concern was that
airflow disturbances could result when the doors from animal holding rooms to the inner corridor are opened.
The BMBL states for areas: Facilities should be re-verified at least modified by
operational experience." Experience would con?rm whether airflow disturbances result from opening the inner
corridor doors, and is not aware ofthis problem occurring. Another concern was the possible entry by
personnel into another animal suite from the inner corridor after exiting an adjacent suite, which may be
construed as not being in agreement with the BMBL wording: "Entry into the containment area is via a
entry which constitutes an anteroomfairlock and a change room." The vivarium is not a single room
but instead is a large multi-room containment block. There are numerous facilities with multi-room
3 containment which do not have an anteroom entrance for all individual laboratory rooms but which have
entry into the overall containment area.

The results of HVAC veri?cation tests for the vivarium, which were performed after the inner corridor airflow
modification was completed, were provided by CDC to the office, confirming that during the failure of
single exhaust fans or during a normal power failurefrestart simulation, there was no reversal of airflow from
potentially contaminated areas into clean areas outside of containment. Exhaust fan failure testing was
performed in December 2010, and the power failurefrestart simulation test was performed in December 2011.

Accession Number: Specia191714 Page: 1364 Scan Date: 2014-09?17 COPY

Airflow Reversal incident

On February 16, 2012, an airflow reversal into the outer vivarium corridor was noted during a tour of the

viva rium by visiting inspectors from the Department of Defense. The visitors in the outer corridor felt a puff of
air from theprocedure room when a laboratorian entered this room from the inner animal holding
room, and the connecting door between the two containment rooms swung closed. The procedure rooms, in
addition to anterooms, have doors which open directly to the outer corridor which are used to bring clean cages
into the suites, These containment boundary doors are equipped with a window and an opening in the window
frame that allows air to flow into the inner laboratory when the ventilation system is operating properly.

An internal investigation of the cause of the airflow reversal determined that the inner door was closing too
swiftly, resulting in a piston-like effect and a puff of air at the outer door window frame opening. Inspectors
from the of?ce visited the vivarium on May 3, 2012 after the inner door closer was adjusted and used
smokesticks to observe the air?ow at the containment boundary doors leading directly into the animal suite
procedure rooms. One or more Ia boratorians sequentially entered multiple suites to open the inner connecting
doors while the inspectors made airflow observations in the outer corridor at the boundary door windows. No
airflow reversals were observed during any of the tests performed. The mechanical problem that caused the
transient airflow reversal had been corrected, and the HVAC system serving the vivarium was verified by the
inspectors to function properly to maintain inward directional airflow under normal conditions.

Accession Number: Specia191714 Page: 1365 Sean Date: 2014-09-17 COPY



- Warrant, Rob 

 

 

 

 


From: Weyant, Rob 
Sent: - Friday, April 13, 2012 7:52 AM
To: icocxopn Pnzosnn
Cc i 31  
Subject: RE: Request for DSAT Training

 

Thanks very' much, . We?ve been asked to do an investigation of this incident. 3 i  has been assigned to

lead up the investigation. He may be getting back with you for additional information.
Best,

Rob Wevant

Robbin S. Weyant, 

Captain, USPHS (Ret)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of? ce phone: 404418-200]

Cell phone: 678-614-T284

SiprNet: jsat209@jricp.dia.smil.mil

BEAT Vision: To be the preeminent resource for the safety and security of bioiogicrnr agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. lfyou are not the intended recipient(s), any dissemination, distribution, or copying is prohibited. lfyou
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

 

From: Imam, mI  
Sent: Friday, April 13, 2012 ?:21 AM

To: Wevant, Rob 
Subject: RE: Request for DSAT Training

Good morning Dr. Wevant,

On February 15, 2012 I escorted the training group over to Bldg. to a training session with ARB personnel.
was in charge of escorting us through the vivarium in building She gave us instructions on their day to
day activities and escorted us only through clean spaces. Because the group had been familiar with donning and doffing
PAPRs, had experience wearing PAPRs in animal spaces and the fact that they would have to shower out if they went
into an animal room} they decided to just go through the didactic part of the training and not enter animal rooms. We
were told that we could observe the technicians through the window. stated that we did not need PPE
in this area as it was "clean". We stood in the clean corridor at the door 0 one animal rooms and as the
technician opened the door from an animal room to the procedure room which was between us and the animal room},
a ?puff? of air came through the slit in the window of the door, and could be felt in the clean hallway. and the inspector

from the Army {forgot his name} were close enough to feel it. i advised of what happened and she told

1
Accession Number: Specia191714 Page: 1366 Sean Date: 2014-09?17 COPY

me that this was a clean room and no animals were Infected in this room. She did, however, state that another room on
this corridor we did not observe anyone in it) did have infected animals in it. As we were walking back to building 20 
and at least twice after we returned the gentleman fro - uented on what had happened in the vivarium.
I sent an email to  mm use. 252m;- land copied Dr. Allison Williams, and Dr. Nathaniel Powell
stating what happened and inquiring if this was a "fluke" or the norm and if this was happening in the infected animal
room: had OHS and ARB done a risk asse ltermine if there was any potential risk to anyone in the clean
corridor without respiratory protection. wrote me back and said that he would look into it. I received no
more communication from him. I do think that there have been conversations between ARB staff and the Biosafety
group concerning this issue, i just don?t know exactly what.

       
 

 

 

 

 

Sincerely,

 

[?lial-

 

 

 

Division of Select Agents and Toxins

Office of Public Health Preparedness and Response
Centers fo Disease Control and Prevention

1600 Clifton Rd. NE MS A46

3011.1
[bli?l

Vision: To be the preeminent resource for safety and security of bioiogicoi agents and toxins.

 

 

 

From: Weyant, Rob (CDCIOPHPRIDSAT)

Sent: Wednesday, April 11, 2012 ?:28 AM
To: [bli?l- libii?l 
'3 

 

 

  
 

Imus: 

 

 

   

[bir?i

-- - (CDQOPH 
Subject: Fw: Request for DSAT Training

 

Good morning

Please see below. Or. Khan has requested that DSAT perform an investigation of this incident. As a starting point, I
would like for you to provide me with a description of the incidentunderstanding that you were
there at the time.

Many thanks,

Rob Weya nt

 

 

From: I?m? Iibi?i (CDCIOPHPRIDSAT)

Sent: Monda A ril 09, 2012 4:02 PM

To: this? this? Weyant, Rob 
Cc: Imi?i Ill-?Fi?? 

Subject: Fw: Request for DSAT Training

 

  

Dr Weyant an  

2
Accession NUmber: Specia191714 Page: 1367 Sean Date: 2014?09-17 COPY

 

I thought this would be of your inlerest. I have another email from - 3" 3
DSAT in future training sessions. I am not sure what exactly happened since thai email

 

 

From: Fire? Ilene limits?- I (cocxommcezm)

Sent: Mon ..  1 - 'l 09, 2012 3:4? PM

 Powell, Nathaniel (CDCIOIDINCEZID) 1 

Cc: Friecm?ll Thomas (Tum) Innis: ?mus;  
Williams, Allison ?13,142, r, ?mpg?, 21  (cociommcezm); '1 i=1 
(CDCIOCOOIOSHE)

Subject: RE: Request for DSAT Training

    
  

 

 

 

 

 

 

ibjzi3::42 use. a 

 

 

 

 

 

 

From: Ilibi'ri?l I (CDCIOPHPRIDSAT)
Sent: Monday, April 09, 2012 10:49 AM
To: Powell, Nathaniel (CDCIOIDJNCEZID)
Cc: Innis: ?was: libiil'?'i ?mils-?- Il?bi?m I. (CDCIOIDINCEZID)
Subject: Request for DSAT Training

 

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to schedule a
training session for the last week of April, 2012 for DSAT FTEs (5 participants). I am waiting to hear back from

3
Accession Number: Specia191714 Page: 1368 Sean Date: 2014-09-17 COPY

 

Ito decide on an exact date. To answer your question: the requirements to enter the ?13342 last tinie-
were TB test and proof of program! respiratory fit test. Again thank you for your support.

4
Accession Number: Specia191714 Page: 1369 Sean Date: 2014-09-17 COPY

 

 

- Wezant, Rob 

 

From: Weyant, Rob PRIDSAT)

Sent: Thursday, April 12. 2012 i146 AM

To: I?m? Ilmii?i 
Subject: RE: Biosafety complaint on the CDC campus
Yes

Robbin S. Weyant, 

Captain, USPHS (Rec)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404-713-200]

Cell phone: 678-614-1984

SiprNet: 

DSAT 1.i?ision: To be the preeminent resource for the safety and security of bioiogicoi agents and toxins.

This document is intended for the exclusive use ofthe recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. ?you
think you have received this document in error, please notify the sender immediately and destroy the original. Thank you.

 

 

From: ibii?} libli?i 
Sent: Wednesday, April 11, 2012 3:32 PM

To: Wevant, Rob 

Subject: RE: Biosafety complaint on the CDC campus

 

Rob,
Would it be okay if I invite to this meeting since she was involved in the training?
Thanks,

 

From: Wevant, Rob (CDCIOPHPRIDSAT)
Sent: Wednesda April 11, 2012 ?:40 AM
To: tie? (cocioeHPRiosar); this
i 3' i 
(CTR)
Subject: FW: Biosafetv complaint on the CDC campus

 

 
  

    

Imii?i I 

   
 

Good morning folks,
Please see the below communications from Dr. Khan and other senior CDC leaders. We need to initiate an investigation

of this incident. In order to avoid the appearance of a con?ict of interest, we need to inform and involve our APHIS
partners. I?ll be working from home this morning, but would like to meet with you tomorrow to discuss.

1
Accession Number: Specia191714 Page: 1370 Sean Date: 2014-09-17 COPY

 

Please set up a meeting for the folks on this message.
Many thanks,

Rob Weyant

 

From: Khan, Ali S. (CDCIOPHPFUOD)

Sent: Tuesday, April 10, 2012 6:49 PM

To: Weyant, Rob (CDCIOPHPFUDSAT)

Cc: Austin, A. Sosin, Dan 
Subject: BiosafetY complaint on the CDC campus

Exactly like the recent complaint, please develop a thoughtful and measured plan.

Given that some may perceive that CDC is inspecting itself, if our response calls for an inspectionfinvestigation after
discossion with the, we should consider the team composition.

Thank you,

 

From: Henderson, Joseph (CDCIOCOOIOSEP)

Sent: Tuesday, April 10, 2012 6:21 PM

To: Arias, Ileana Barger, Sherri Seligman, James D. 
Ce: Khan, Ali S. Khabbaz, Rima Bell, Beth (CDCIOIDINCEZID)
Subject: Re: Complaint of Biosafety violations on the CDC campus

Ileana, Sherri, and Jim, many staff from the 3505 and from NCEZID were engaged in discussions today related to the
issue that Wilma?  raised pertaining to a perceived safety issue in thelab in the SB of 
We are working on a one-pager related to this event but need program input which we will have in the morning. Nate
Powell had a meeting with today and I wanted to hear how that went before we ?nalize our full assessment of
this issue.

 

i'll get this to you first thing in the morning.

Joe

 

From: Arias, Ileana (CDCIOD)

Sent: Tuesday, April 10, 2012 02:54 PM

To: Henderson, Joseph (CDCIOCOOIOSEP)

Subject: RE: Complaint of Biosafety violations on the CDC campus

Thanks. Let me know what is going here and what if anything weaned to do.

-

From: Henderson, Joseph (CDCIOCOOIOSEP)

Sent: Tuesday, April 10, 2012 11:10 AM Eastern Standard Time

To: Berger, Sherri Seligman, James D. Khan, Ali S. 
Bell, Beth Khabbaz, Rima Chu, May Arias,
Ileana 

Cc: Meechan, Paul J. Chandler, George Henderson, Joseph

2
Accession Number: Specia191714 Page: 1371 Sean Date: 2014-09-17 COPY


i Subject: FW: Complaint of Biosafety violations on the CDC campus

 

   

S-

U.S.C. 2523

 

 

 

All. I have asked Paul Meechan to set up a meeting today with OSHE, BFO, from NCEZID, 
from LSBPO. and me to get the facts on this complaint and assure we are all completely clear on this issue before further
actions are taken. I will be sure to provide an update once we have the call and have the facts straight and actions clear.

 

Keep in mind I'm taking the helm on this issue in my new role providing oversight of the process to consolidate OSEP,
OSHE1 BFO. Sustainability and Logistics Management from PGO. Just in case you are curious as to why I initiated this
email) If anyone wants to discuss please let me know.

Joseph M. Henderson
Director. O?'ice of Security and Emergency Preparedness

Centers for Disease Control and Prevention (CDC)
U. S. Department of Heeith and Human Services
404-639-7?131

 

ibj;i;3j::42 use. 

 

 

 

3
Accession Number: Specia191714 Page: 1372 Sean Date: 2014-09?17 COPY

future training}. The complainant does initially appear to confuse our inspector?s visits as guests to the CBC-
facilities before going on to discuss CDC Safety and aiflow issues but we will handle this within the DSAT 
regulatory role.

Thanks,

Ali

 

From: Weyant, Rob (CDCJOPHPRIDSAT)

Sent: Tuesday, April 10, 2012 3:50 AM

To: Khan, Ali 5. Austin, A. Sosin, Dan 
Subject: FW: Request for DSAT Training

Good morning folks,

FYI, please see below. I?ve asked my folks to follow up and brief me on the incident. The tour was supposed
to be at a portion of the facilityl that was undergoing maintenance and cold.

Rob Wevant

Robbin S. Weyant,-PhD, REHABSA)

Captain, USPHS (Rot)

Director, Division of Select Agents and Toxins
Of?ce of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Of?ce phone: 404-713-200l

Cell phone: 613-614-384

SiprNet: isat209@irico.dia.smil.mil

DSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.

This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that is
protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive
such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly prohibited. lfyou
think you have received this document in error, please notify the sender immediately and destroy,r the original. Thank you.

 

 

From: Fifi? 

Sent: Monda A rii 09, 2012 4:02 PM

To: I ibimi Weyant, Rob 
Cc: Him? 

Subject: FW: Request for DSAT Training

Dr Weyant and

I thought this would be of your interest. i have another email from saying how pleased she was to help
DSAT in future training sessions. lam not sure what exactly happened since that email

 

 

 

From: this Irw- l(cocromil~lcezm)
Sent: Monda Aril 09, 2012 3:4? pm
- i=1: Powell, Nathaniel 

  

 

 

4
Accession Number: Specia191714 Page: 1373 Sean Date: 2014?09?17 COPY

 Williams, Allison (cociommcenp); .  
(cocrocoolosHE)
Subject: RE: Request for DSAT Training

?3:13:42 U30. 

 

 

 

 

 

 

 

i' (CDCIOPHPRIDSAT)

Sent: Monday, April 09, 2012 10:49 AM

To: Powell, Nathaniel (CDCIOIDINCEZID)

CC:   I?bi?i?" ?mm? (CDCIOIDINCEZID)
Subject: Request for DSAT Training

 

Dr Powell

Following our conversation from this morning; first I want to thank you for your support. We are trying to
schedule a training session for the last week of April, 2012 for DSAT FTEs [5 participants). I am waiting to hear
back from Ilmi??i ?lb-?53 Ito decide on an exact date. To answer your question: the requirements to

enter the - 3 i? . last time were TB test and proof of programir respiratory ?ttest. Again thank you for your
support.

 


Accession Number: Specia191714 Page: 1374 Sean Date: 2014-09-17 COPY

 



Wezant. Rob 



Thursday, April 12, 2012 10:13 AM

[hie-=42 IE: Weyant, Rob 
Chu, May 

From:
Sent
To:
Cc:

Subject:
Attachments:

Rob,

RE: Report Requested

2012 02 14 ?333342

I am resending with the attachment.

 

Regards.

  

   

Sent: Thursday, Apri

 

12, 2012 10:03 AM

To: Weya nt, Rob (cocroPHPR/osm
Cc: Chu, May 
Subject: Report Requested

Good Morning Rob,

airflowdoc

i understand that you have requested a copy of the attached report.

[1 Attachment]

Respectfully submitted,



 

 


262mm

 

 

 

'2523thj: 

Accession Number 

Specia191714

page: 1375 Scan Date: 2014?09-17 COPY

  
 

I OF HEALTH HUMAN SERVICES Public Health Service

 

Centers for Disease Control and Prevention 
Of?ce of Safety, Health and Environment
Atlanta GA 30333

April 12,2012

Late in the afternoon on February] 6, 201 OSHE was noti?ed of a potential air ?ow incident in
the Building 3.3 . - - OSHE representatives responded ?rst thing the next morning to
investigate. The incident occurred while viewers were in the ?clean? corridor  viewing
(?3?42 animal holding areas through the procedure room door of ?Hm? - use. 5:2523 lab is
assigned to the branch. While viewing prairie dogs held within the holding room, a

 

       

 

door between the holding room and procedure room closed with greater force than required,

sending a small ?puff? of air out through the slotted window door on the clean corridor 

 

     

. . - negative prairie dogs that had just been moved in a few weeks prior. - -
been in December of 2010 and no virus had been worked with in that room since the
December decon. The room was clean of any virus and the animals being housed in

U-S-C- 2523?? lfor Imi. lvirus (previously tested in November 2010 and January
201 

 

The evaluation by OSHE was that although the ?puff? of air out through the-slotted wind0w
should not have occurred, there was no exposure risk to those at the door during the incident. All
compliance parties involved determined no exposure occurred and thus it did not trigger the
requirement that exposures be reported to DSAT. A call was made to BFO to have the doors in
the suite examined and door closers were adjusted and tested.

Corrections have been made and all animal room doors close properly without causing an air?ow
disruption on th waiti?iea corridor. After action items included discussions with ARB to
continue to monitor the doors and if at any tirne in the future any closure issues were observed
they were to contact the Manager or the OSHE Biosafety Manager. BFO has also reviewed
the PM for this area to ensure that door closers are evaluated annually for adjustments to proper

set points.

 

 

 

 

 

[b}i3}:42 U30. 252mb}

 

 

 

Of?ce of Health and Safety

Accession Number: Specia191714 Page: 1376 Sean Date: 2014-09?17 COPY

Executive Summaries 3/19f2012

Centers for Disease Control and Prevention

Lung 
 I ?$93342 U-S-C-WBQEW  rojv:3}:42 U.S.C.?252afh}  uses  uses

9HDm'h".

 

VERSION SENT TO COMMITTEE

Key Issues/Incidents

January 1,2005 - June 22, 2012

On June 25, 2012 the House Energy and Commerce Committee requested information regarding the "safety of

 

Building Information requested included reports of

 

biosafety incidents, emails, meeting minutes, slides, and other documents that described the agency?s corrective
actions or recommendations since January 1, 2005. In response, CDC staff collected and reviewed a large
volume of documents. In the process of this review it became apparent that the information is highly detailed
and somewhat difficult to follow. This document is provided as a framework to aid in the review and

understanding of these materials. As such, it is not intended to be a detailed account of all safety issues related
to Building

The following narrative pertains to nine key issues or important incidents that arose or occurred since 2005 in
The events specifically pertain to either safety or security incidents to which CDC responded, or incidents
that relate to certain thematic issues that tended to resurface over time Access Control Issues].

 

 

 

 

 

 

 

 

 

Contents

1. ?Puff of Air? Incident 
[Out of Scope]

3. Access Control
[Out of Scope]

6. Lab Air Redirection
[Out of Scope]

8. Doors in theI INot Compliant with National Fire Protection

Association Fire Code
9. Vivarium Air Redirect 

 

 

 Executive Summaries Eng/2012
?Puff of Air" Incident

On February 16, 2012, a group of trainees who were visiting the facility in a clean corridor reported a
"puff of air? coming through one of the open air slots in a door coming from a vivarium
procedure room and animal holding area. The suite had been decontaminated, was not active at the time, and
no select agents were in the vicinity. However, individuals from the group of trainees were concerned that the
"puff of air? indicated a reversal of air flow, meaning they could have possibly been exposed to contaminated air
from the lab. health and safety team investigated the event the following day to ensure there was no
possible exposure to the visiting trainees. In concert the Office of Safety, Health, and Environment (OSHE) and
the Buildings and Facilities Office (BFO) determined that the closure of an internal door generated the air?pr 
and a simple adjustment of the door closure mechanism resolved the issue. After these adjustments, CDC safety
staff could not recreate the event during additional testing. A more detailed investigation was completed by the
Division of Select Agent and Toxins (DSAT) in May 2012 to determine if additional corrective actions were
needed. The DSAT investigation included interviews with staff and a verification exercise conducted under the
same conditions that were present at the time of the incident. DSAT confirmed that remedial actions had
corrected the problem.

CDC has modified their Preventive Maintenance program in the lab to assure automatic door closure
devices are checked to ensure proper operation.

 Executive Summaries

ails/2012
Access Control Issues

Identified Issues

1} Alleged report of an unauthorized individual in Vivarium
2} Open door alarms in laboratories
3} Procedure for approving and managing access for labOratories

Overview and Actions

1}

2}

Alleged report of an unauthOrized individual

Background

On April 29th, 2010, the CDC Security Operations Center notified the Select Agent Responsible Official
that there was a report that an unauthorized employee was in themvivarium in Building
This was reported when a contract guard was responding to a ?propped door alarm? the day prior. The
SARO discovEred that the identified employee did not have access to the area and reported the incident to
the manager of the

Upon investigation, it was determined that the SOC mistakenly reported the propped door alarm as having
taken place in when in fact the propped door alarm was actually coming from Building Room 
an area to which the employee in question does have authorized access. This was verified by:

The employee?s personal account the day ofthe incident [at 2:23pm).
I The SOC team leader?s indication that she mistakenly emailed the SARO the incorrect location of the
alarm (day of the reported incident at 10:01pm).
- The report ofa Security Assistant who spoke with the reSponding security guard. The security guard
confirmed that she was dispatched to Building where she spoke with the employee in question
about the propped door alarm {email dated April 30 at 8:50 am).
[more  reports place the employee in question in Building Elsix minutes before
the security was dispatched to investigate the open door alarm.

 

Conclusion
Based on the investigation it is evident that the individual was not in an unauthorized location in 

Open door alarms in laboratories

Background

The CDC Office of Security and Emergency Preparedness was asked to provide an overview of open
(propped) door alarms ilaboratories and how they are resolved. Propped door alarms occur for
several reasons, including programs or other personnel intentionally propping the door open (to bring
equipment into the lab}; holding the door open for too long a period of time; mechanical issues with the
door latching mechanism; or an actual security breech identifying the door is being forced open. The CDC

SOC reports that there has never been a recorded incident of a security breech and most alarms are due to
6

 Executive Summaries 3309/2012

staff propping open the doors or when placing too much force on the doors to get them to open. It is
important to note that CDC stations guards at the main entrance and on roving patrols in E?to provide an
additional layer of security assuring only authorized personnel enter the facility and to respond to door
alarms once they are signaled in the SOC.

response to propped doors is as follows:

In The SOC receives all alarms related to Select Agent areas and dispatches a guard each time to
investigate the alarm and conduct a visual inspection of the area. If the guard does not have
authorized access to an area, the SOC works with authorized program officials to understand the
nature of the alarm and to document the event.

0 Non-Select Agent propped doors are detected by program officials in the area, by roving guards, or
as part of the alarm vetting process {Top Ten Alarm List) which is completed by OSEP and
maintained by the CDC Buildings and Facilities Office (BFO). The ?Top Ten List? is generated from
the P2000 Physical access control system (PACS) of doors with the ten highest number of access
alarms. This report can be generated to include only doors in specific areas of the facilities such as
the Egg 

- Program officials or facilities personnel reset alarms.

- If the alarm is activated due to a mechanical issue, the SOC, or the program will submit a
maintenance request to CDC's BFO.

Action Step

I Security is working with program officials in mm formalize the listing of critical alarms (in addition
to select agent areas] that require immediate security response. SOPs will be modified to reflect
these changes.

0 Security and facilities staff are working to eliminate recurring problems. Since January 2012, the
OSEP has conducted detailed testing of 90% of the door alarms in to ensure the alarms function
properly (doors that had active  work in progress could not be tested until the labs
are down for maintenance}. Only a small percentage ofthe door alarms tested had issues, and
those were repaired. This is a mandatory annual preventative maintenance for doors at all CDC
laboratories.

 

3} Procedure for approving and managing access for laboratories

Background
OSEP and program officials were asked to provide information related to approvingfmanaging access to 
3 laboratories.

Granting Access
If the access is for a non-select agent restricted area, the request is submitted to an Authorizing Official for
approval. This approval is transmitted to OSEP either by email or by signed and completed CDC Form 834.

If access is for a select agent area, an approved signed and completed select agent access request form is
submitted to OSEP. Access is governed by specific policies and procedures (Roybal Campus Select Agent
Security Access and Accountability Procedures Updated Access must be requested by the
Principal Investigator and approved by the Responsible Official (R0). The OSEP Ca rdkey Office maintains
a list of officials who are approved to request access to restricted card readers.

 Executive Summaries 3f19/2012
3-.4

Managing Access

The PI is responsible for notifying OSEP of am,r personnel changes that would require a change i
!n select agent registered labs, the R0 reviews access logs on a quarterly basis. However, there isn't

currently a formalized process for reviewing access logs for non?select agent registered labs on a regular

basis.

The 2:522:31! 'l lis reaponsible for managing access for users and suppOrt personne outside of Select

.

Agent Areas and in th vivarium. Th? - oes not control th ?35$ aboratories in the

987nfh's

 

 

 

 

   

 

Iaboratorv tower.

Action Steps
While operating procedures and several procedural documents do exist, there is a need to formalize a step?

bv-step process for obtainingfmaintaining access tolaboratories.

Program officials and OSEP personnel are formalizing a process for improving management of authorized
access staff rosters.

 Executive Summaries 3309/2012

In September of 2008 the BFO determined a permanent fix to ensure proper operation of the system would be
to provide a separate air handler, ductwork and controls for thelab to prevent airflow reversal during
restart of the air systems following power outages. The design of the project was started in February of 2008
and in July of 2008 the project construction was proposed and approved by the CDC Facilities Board. The
construction on the mproject was started in February of 2009 and was completed in May of 2009. On
April 16, 2009 the fans in both theand vivarium areas were tested and functioned as designed.

13

 Executive Summaries 3309/2012

Doors in the Not Compliant with NFPA Fire Code

During the commissioning of the Vivarium upon completion of construction, the commissioning agent
responsible for test and balance of the air system concluded in a commissioning report dated March 2011 that,
"Upon dual supply shut down, egress from the vivarium was deemed unacceptable by 
Engineering and Management Office (DEMO). The Commissioning {Cx) Tests demonstrated that the force
required to open doors during supply fan failure does not meet the NFPA 101 Life Safety Handbook?.
Calculated figures may or may not reflect actual physical tests of door opening forces, as the actual force
required to release the latch, set the door in motion, and fully open the door were not measured. The
commissioning report found that five doors located in the vivarium area were out of compliance with NFPA
101 Life Safety Code.

The CDC engineering review of this information revealed an error in the code interpretation on the part of the
commissioning consultant. The consultant failed to note that several movements are necessary to operate a
door from its closed to its fully open position. The code identifies each of the movements and limits {in a
prescriptive manner} the force required to accomplish each. With a correction applied to the existing
calculations, it would now appear that only 3 of the 5 doors are potentially out of compliance with this code
during the most extreme egress scenario. On June 18, 2012, CDC BFD in collaboration with the CDC DSHE
performed a door-opening force test on the five doors noted within the commissioning report. All doors tested
met the requirements of NFPA 101 under normal egress conditions. At this time, CDC engineers and DSHE
determined that empirically testing these egress doors during extreme egress conditions is the only way to fully
determine if the doors actually meet Life Safety Code requirements during these extreme failure conditions.

CDC performed the empirical testing of the egress doors on July 24, 2012. Eight separate doors were tested
under the most extreme scenarios. Three doors were added to ensure all the doors were in compliance.

0 Two doors which access the emergency stairways were not in compliance under the most extreme
scenario. CDC will install power door openers on the stairway doors to ensure compliance with the
code. The doors openers should be installed by the end of August 2012.

into the south clean corridor was found to require force greater

  

I The door which allow I
than the maximum force required to disengage the electronic lockset under extreme load conditions.
CDC engineers are considering several options to fix this problem including the strike set with a latch
which will disengage easily under the extreme conditions. This door continues to operate as designed
under normal and fire evacuation conditions

- CDC will create a preventive maintenance (PM) line item to perform annual function testing and
verification that egress doors in this area meet applicable safety codes and standards.

15

 Executive Summaries 3f19/2012
Air Redirect Project/Anterooms

The vivarium was originally designed to allow air to flow from the outer clean corridor through the animal rooms
and into a common central The Biosafetv in Microbiological and Biomedical Laboratories (BMBL)
5?h edition {published after Building was constructed) forl [more Estates the direction of air
into the animal facility is inward from the adjacent areas effectiver ensuring a cleaner corridor and room on

 

 

both sides of the animal holding rooms. Prior to occupancyI in the vivarium, OSHE observed lab conditions,
identified corrective changes, and communicated these corrective changes that needed to be made to the
operational parameters of the facilitv based on the new BMBL 5th edition.

In order to ensure compliance with the current BM BL, the Office of Health and Safetv (currently the 
proposed a project to redirect the air flow from the central corridor into to the animal holding rooms. OHS
requested the project through the CDC Facilities Board in March 2009. Consideration for the vivarium project
was delayed due to the ongoing project to correct a separate air flow issue in the Ellab. At the completion
of the El project the BFOfFacilities Management and Engineering Office asked the H06 to approve
the project. On March 26th, 2009 the HOG reviewed and approved the project.

16

Executive Summaries 3/19f2012

Centers for Disease Control and Prevention

- [urbane Lung 
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INTERNAL USE ONLY WITH TIMELINE

Key Issues/Incidents

January 1,2005 - June 22, 2012

On June 25, 2012 the House Energy and Commerce Committee requested information regarding the "safety of
Building I Information requested included reports of

 

biosafety incidents, emails, meeting minutes, slides, and other documents that described the agency?s corrective
actions or recommendations since January 1, 2005. In response, CDC staff collected and reviewed a large
volume of documents. In the process of this review it became apparent that the information is highly detailed
and somewhat difficult to follow. This document is provided as a framework to aid in the review and
understanding of these materials. As such, it is not intended to be a detailed account of all safety issues related

to Building

The following narrative pertains to nine key issues or important incidents that arose or occurred since 2005 in
The events specifically pertain to either safety or security incidents to which CDC responded, or incidents
that relate to certain thematic issues that tended to resurface over time Access Control Issues].

 

 

 

 

 

 

 

 

 

 

 

 

 

Contents
1. ?Puff of Air? Incident 
I [Out of Scope]
3. Access Control
[Out of Scope]
[Out of Scope]
6. El Lab Air Redirection
[Out of Scope]
8. Doors in thel [hii31142U-3-?3-?2523ihi INot Compliant with National Fire Protection
Association Fire Code
9. Vivarium Air Redirect 

Timeline January 2005 June 2012 found on page 17

 Executive Summaries Eng/2012
?Puff of Air" Incident

On February 16, 2012, a group of trainees who were visiting the facility in a clean corridor reported a
"puff of air? coming through one of the open air slots in a door coming from a vivarium
procedure room and animal holding area. The suite had been decontaminated, was not active at the time, and
no select agents were in the vicinity. However, individuals from the group of trainees were concerned that the
"puff of air? indicated a reversal of air flow, meaning they could have possibly been exposed to contaminated air
from the lab. health and safety team investigated the event the following day to ensure there was no
possible exposure to the visiting trainees. In concert the Office of Safety, Health, and Environment (OSHE) and
the Buildings and Facilities Office (BFO) determined that the closure of an internal door generated the air?pr 
and a simple adjustment of the door closure mechanism resolved the issue. After these adjustments, CDC safety
staff could not recreate the event during additional testing. A more detailed investigation was completed by the
Division of Select Agent and Toxins (DSAT) in May 2012 to determine if additional corrective actions were
needed. The DSAT investigation included interviews with staff and a verification exercise conducted under the
same conditions that were present at the time of the incident. DSAT confirmed that remedial actions had
corrected the problem.

CDC has modified their Preventive Maintenance program in the lab to assure automatic door closure
devices are checked to ensure proper operation.

 Executive Summaries

ails/2012
Access Control Issues

Identified Issues

1}
2}
3}

Alleged report of an unauthorized individual in Vivarium
Open door alarms in laboratories
Procedure for approving and managing access for labOratories

Overview and Actions

1}

2}

Alleged report of an unauthOrized individual

Background

On April 29th, 2010, the CDC Security Operations Center notified the Select Agent Responsible Official
that there was a report that an unauthorized employee was in themvivarium in BuildingEEl.
This was reported when a contract guard was responding to a ?propped door alarm? the day prior. The
SARO discovEred that the identified employee did not have access to the area and reported the incident to
the manager of the

Upon investigation, it was determined that the SOC mistakenly reported the propped door alarm as having
taken place in when in fact the propped door alarm was actually coming from Building Room 
an area to which the employee in question does have authorized access. This was verified by:

The employee?s personal account the day ofthe incident [at 2:23pm).

I The SOC team leader?s indication that she mistakenly emailed the SARO the incorrect location of the
alarm (day of the reported incident at 10:01pm).

- The report ofa Security Assistant who spoke with the reSponding security guard. The security guard
confirmed that she was dispatched to Building where she spoke with the employee in question
about the propped door alarm {email dated April 30 at 8:50 am).

0 I (WW U-S-C- 25230?? Ireports place the employee in question in Building El six minutes before
the security was dispatched to investigate the open door alarm.

 

Conclusion
Based on the investigation it is evident that the individual was not in an unauthorized location in 

Open door alarms in laboratories

Background

The CDC Office of Security and Emergency Preparedness was asked to provide an overview of open
(propped) door alarms in laboratories and how they are resolved. Propped door alarms occur for
several reasons, including programs or other personnel intentionally propping the door open (to bring
equipment into the lab}; holding the door open for too long a period of time; mechanical issues with the
door latching mechanism; or an actual security breech identifying the door is being forced open. The CDC

SOC reports that there has never been a recorded incident of a security breech and most alarms are due to
6

 Executive Summaries

33?19/2012

staff propping open the doors or when placing too much force on the doors to get them to open. It is
important to note that CDC stations guards at the main entrance and on roving patrols in E?to provide an
additional layer of security assuring only authorized personnel enter the facility and to respond to door

alarms once they are signaled in the SOC.

response to propped doors is as follows:

The SOC receives all alarms related to Select Agent areas and dispatches a guard each time to
investigate the alarm and conduct a visual inspection of the area. If the guard does not have
authorized access to an area, the SOC works with authorized program officials to understand the
nature of the alarm and to document the event.

Non-Select Agent propped doors are detected by program officials in the area, by roving guards, or
as part of the alarm vetting process {Top Ten Alarm List) which is completed by OSEP and
maintained by the CDC Buildings and Facilities Office (BFO). The ?Top Ten List? is generated from
the P2000 Physical access control system (PACS) of doors with the ten highest number of access
alarms. This report can be generated to include only doors in specific areas of the facilities such as
the ESE 

Program officials or facilities personnel reset alarms.

If the alarm is activated due to a mechanical issue, the SOC, or the program will submit a
maintenance request to CDC's BFO.

Action Step

Security is working with program officials in mm formalize the listing of critical alarms (in addition
to select agent areas] that require immediate security response. SOPs will be modified to reflect
these changes.

Security and facilities staff are working to eliminate recurring problems. Since January 2012, the
OSEP has conducted detailed testing of 90% of the door alarms in to ensure the alarms function
properly (doors that had active work in progress could not be tested until the labs
are down for maintenance}. Only a small percentage ofthe door alarms tested had issues, and
those were repaired. This is a mandatory annual preventative maintenance for doors at all CDC
laboratories.

3} Procedure for approving and managing access for laboratories

Background

OSEP and program officials were asked to provide information related to approvingfmanaging access to 
3 laboratories.

Granting A ccess

If the access is for a non-select agent restricted area, the request is submitted to an Authorizing Official for

approval. This approval is transmitted to OSEP either by email or by signed and completed CDC Form 834.

If access is for a select agent area, an approved signed and completed select agent access request form is

submitted to OSEP. Access is governed by specific policies and procedures (Roybal Campus Select Agent
Security Access and Accountability Procedures Updated Access must be requested by the

Principal Investigator (PI) and approved by the Responsible Official (R0). I

 

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 Executive Summaries Eng/2012

Managing Access

The PI is responsible for notifying OSEP of am,r personnel changes that would require a change in ca rdkev
access. in select agent registered labs, the R0 reviews access logs on a quarterly basis. However, there isn't
currentlv a formalized process for reviewing access logs for non?select agent registered labs on a regular
basis.

The Emis responsible for managing access for users and support personnel outside of Select
Agent Areas and in thevivarium. The does not control the EEZI laboratories in the
laboratorv tower.

Action Steps
While operating procedures and several procedural documents do exist, there is a need to formalize a step?
bv-step process for obtaining/maintaining access to mm laboratories.

Program officials and OSEP personnel are formalizng a process for improving management of authorized
access staff rosters.

 Executive Summaries 3309/2012

In September of 2008 the BFO determined a permanent fix to ensure proper operation of the system would be
to provide a separate air handler, ductwork and controls for thlab to prevent airflow reversal during
restart of the air systems following power outages. The design of the project was started in February of 2008
and in July of 2008 the project construction was proposed and approved by the CDC Facilities Board. The
construction on the mproject was started in February of 2009 and was completed in May of 2009. On
April 16, 2009 the fans in both the no vivarium areas were tested and functioned as designed.

13

 Executive Summaries 3309/2012

Doors in the Not Compliant with NFPA Fire Code

During the commissioning of the Vivarium upon completion of construction, the commissioning agent
responsible for test and balance of the air system concluded in a commissioning report dated March 2011 that,
"Upon dual supply shut down, egress from the vivarium was deemed unacceptable by 
Engineering and Management Office (DEMO). The Commissioning {Cx) Tests demonstrated that the force
required to open doors during supply fan failure does not meet the NFPA 101 Life Safety Handbook?.
Calculated figures may or may not reflect actual physical tests of door opening forces, as the actual force
required to release the latch, set the door in motion, and fully open the door were not measured. The
commissioning report found that five doors located in the vivarium area were out of compliance with NFPA
101 Life Safety Code.

The CDC engineering review of this information revealed an error in the code interpretation on the part of the
commissioning consultant. The consultant failed to note that several movements are necessary to operate a
door from its closed to its fully open position. The code identifies each of the movements and limits {in a
prescriptive manner} the force required to accomplish each. With a correction applied to the existing
calculations, it would now appear that only 3 of the 5 doors are potentially out of compliance with this code
during the most extreme egress scenario. On June 18, 2012, CDC BFD in collaboration with the CDC DSHE
performed a door-opening force test on the five doors noted within the commissioning report. All doors tested
met the requirements of NFPA 101 under normal egress conditions. At this time, CDC engineers and DSHE
determined that empirically testing these egress doors during extreme egress conditions is the only way to fully
determine if the doors actually meet Life Safety Code requirements during these extreme failure conditions.

CDC performed the empirical testing of the egress doors on July 24, 2012. Eight separate doors were tested
under the most extreme scenarios. Three doors were added to ensure all the doors were in compliance.

0 Two doors which access the emergency stairways were not in compliance under the most extreme
scenario. CDC will install power door openers on the stairway doors to ensure compliance with the
code. The doors openers should be installed by the end of August 2012.

I The door which allows into the south clean corridor was found to require force greater
than the maximum force required to disengage the electronic lockset under extreme load conditions.
CDC engineers are considering several options to fix this problem including the strike set with a latch
which will disengage easily under the extreme conditions. This door continues to operate as designed
under normal and fire evacuation conditions

- CDC will create a preventive maintenance (PM) line item to perform annual function testing and
verification that egress doors in this area meet applicable safety codes and standards.

15

 Executive Summaries 3f19/2012

fb}f3}242 U.S.C. 252301}

 

 

 

Air Redirect Project/Anterooms

 

The vivarium was originally designed to allow air to flow from the outer clean corridor through the animal rooms
and into a common central  l:  . The Biosafetv in Microbiological and Biomedical Laboratories (BMBL)
5?h edition {published after Building was constructed) for animal mu states the direction of air
into the animal facility is inward from the adjacent areas effectiverr ensuring a cleaner corridor and room on

 

both sides of the animal holding rooms. Prior to occupancyI in the vivarium, OSHE observed lab conditions,
identified corrective changes, and communicated these corrective changes that needed to be made to the
operational parameters of the facilitv based on the new BMBL 5th edition.

In order to ensure compliance with the current BM BL, the Office of Health and Safetv (currently the 
proposed a project to redirect the air flow from the central corridor into to the animal holding rooms. OHS
requested the project through the CDC Facilities Board in March 2009. Consideration for the vivarium project
was delayed due to the ongoing project to correct a separate air flow issue in the Ellab. At the completion
of the El project the BFOfFacilities Management and Engineering Office asked the H06 to approve
the project. On March 26th, 2009 the HOG reviewed and approved the project.

16

Executive Summaries 3/19[2012
Timeline lanuary 1, 2005 lune 22, 2012

 

 

[Out of Scope]

 

 

January 15, 2003: DSAT inspects facilitv in  

Vivarium] for initial registration.

Januaryr 30, 2008: autoclave malfunction steam release when opening autoclave. No release. Followed
up by DSAT Form 3 report.

February 2008: Design for [El isolation began. The Elisolation project was conducted to isolate the
airflow of the El labs from the rest of the vivarium to correct inadvertent air flow between labs.

May 15, 2008: AJC article about the delays in the opening of ED published.

 

 

May 2?-30, 2008: DSAT inspects Ugh}:
Pathogens Branch for initial registration.

 

252 facility and [moi-A2 use. 252mm Hm Special

 

June 2003: '3 9 lOperations Group (HOG) formed to oversee the day to day
operations of the 

(bjrf3j1142 use. 252mm

 

 

 

 

 

October 2008: DSAT inspects in Iii-'5; El viva rium for and performs renewal
inspection for the remainder of the registered select agent rooms and laboratories.

 

 

 

[Out of Scope]

 

 

17

 

Executive Summaries 3/192?2012

February 2009 May 2009: Construction begins on isolation project. The labs were down
during this time. The rest of the vivarium remained functioning except for a few weeks in April 2009.
This project was self?commissioned.

March 2009: Vivarium project requested through the CDC Facilities Board.
April 16, 2009: Fans in both El and Vivarium were tested; email sent to staff that fans were operational.
May 7, 2009: Animals moved in to vivarium.

May 13, 2009: Infectious work begins in vivarium by the Division.

 

October 2009: GAO report on . . National Strategy for Oversight. The report addresses the
June 2007 lightning strike on Building

October 2009: inspects animal facility. Final accreditation received March 15, 2010.

October 2009: Design for vivarium air redirection began. The purpose of the air redirection project was to
minimize the size of the potentially contaminated areas within the vivarium, specifically in the return
corridor. Doors were also upgraded and end users were involved in pre?design.

October 19, 2009: Risk assessment was completed for the Nu Air cage changing stations.

November 17, 2009: Doors found open at outer perimeter of suite near elevator. Office of Security and
Emergency Preparedness continues to do functional tests on doors on an annual basis to ensure
compliance with security requirements.

December 3, 2009: The HOG Met and no significant issues were raised about the Vivarium re-direct project.

January 26, 2010: HOG meeting members debate the need to conduct a risk assessment relative to the air-
redirection project in the vivarium. It was determined by safety officials that an assessment was not
needed. Animal Research Branch will update SOPs at the end of the redirection project.

February 15, 2010: BFO staff present a design update at HOG meeting regarding the vivarium air redirection
project. Members discuss concerns.

 

 

[Out of Scope]

 

February 2010: Facilities engineers update scientists on air redirection project, decision made to proceed.

March 10, 2010: George Chandler email concurrence with reversal George Chandler
Nicholsonfieff Williams. Documents signed byand confirm vivarium air
direction project should proceed. concurred.

 

March 11, 2010: DSAT inspects for use as by Ins-??ows
March 12, 2010: ARB employee continues to disagree on decision to redirect air flow in the ESE

March 15, 2010: accreditation received.

18

 

Executive Summaries 3/19f2012
April 28, 2010: Report of an unauthorized individual (employee) in Building Vivarium.

 

 

[Cutoi Scope]

 

 

October 12-22, 2010: DSAT conducts renewal inspection of CDC facilities.

November 2010 January 2011: Construction for the vivarium project (redirection) occurs.

 

 

[Out of Scope]

 

 

December 18, 2010: The recommissioning of the vivarium project was completed. The fire door issue was
discovered.

January 2011: Vivarium goes live after air redirection project is completed.

 

 

[Out of Scope]

 

  



December 2011: Vivarium shut down for annual maintenance. use. s262 lab activity continues.

M342 usc.

 

December 13, 2011: DSAT inspection of in facility fo 252m}

 

 

[Out of Scope]

 

 

February 16, 2012: Trainees in clean corridor of vivarium (puff of air incident).
February 16-12, 2012: OSHE evaluated the area of the puff incident.

February 20-24, 2012: Adjustments were made to two doors in the area of the puff incident to slow doors down
during closing. The puff of air was thought to be caused by the door closing too quickly.

April 25, 2012: DSAT meets with CDC Select Agent Responsible Official (SARD) and others to discuss
vivarium incident (air puff) and subsequent analysis.

 

 

[Out of Scope]

 

 

May 1-3, 2012: DSAT meets with various Animal Resource Branch (ARR), OSHE, and RFC staff to discuss
vivarium incident (air puff).

May 3, 2012: DSAT conducts smoke testing in vivarium due to puff incident. Puff of air could not be
replicated.

June 13, 2012: USAToday article published (air puff! fire code violations with doors in vivarium)
19

 

 Executive Summaries Wig/2012

June 14, 2012: Egress doors were tested for force required to open under normal circumstances. Pressure was
found to be approximately 15 Ibf, below the 30 Ibf maximum force allowed by code. BFO will continue
testing doors to ensure compliance with fire code.

June 15, 2012: CDC management recommends that and Plant Health Inspection Service 
become lead inspection group for Select Agent inspections.

July 15, 2012: Final decision memo was signed by Dr. Tom Frieden Director} with program concurrence
indicating no further action regarding anterooms was needed.

20