UNCLASSIFIED
EXECUTIVE SUMMARY
AR 15-6 INVESTIGATION REPORT – INDIVIDUAL AND INSTITUTIONAL
ACCOUNTABILITY FOR THE SHIPMENT OF VIABLE BACILLUS ANTHRACIS FROM
DUGWAY PROVING GROUND
December 17, 2015
Background: On 22 May 2015, a private company notified the Centers for Disease Control and
Prevention (CDC) that it found a low concentration of viable (live) Bacillus anthracis spores in a
shipment from the U.S. Army that should have only contained non-viable (dead) spores. The
CDC notified the Department of Defense (DoD) of this unauthorized shipment of viable Bacillus
anthracis and determined that the material originated at Dugway Proving Ground (DPG), Utah.
As a result, the CDC and the DoD investigated DPG’s history of Bacillus anthracis inactivation
and determined that between 2004 and 2015, the Life Sciences Division at DPG (DPG-LSD)
prepared a total of 86 lots of inactivated Bacillus anthracis, in support of the Critical Reagents
Program (CRP) at Fort Detrick, Maryland. The CRP serves as a source for biological materials
(such as inactivated Bacillus anthracis) used to develop countermeasures required to protect U.S.
military forces from biological threats. The CRP maintains its Antigen Repository at DPG-LSD.
The CRP routinely directs the shipment of biological materials produced at the Antigen
Repository at DPG-LSD to external government and commercial laboratories involved in
countermeasure development. The CRP Antigen Repository is the only DoD laboratory engaged
in large-scale production and shipping of select agents to external entities.
At the time of production, DPG-LSD conducted viability testing that demonstrated that no
live Bacillus anthracis remained, so a death certificate was issued for each of these 86 lots.
Following the 22 May 2015 discovery by the private company, DPG-LSD used a newly
developed CDC protocol to re-test the viability of the lots of inactivated Bacillus anthracis
remaining in its inventory (33 of the original 86). Results showed that 17 of the 33 lots
contained low concentrations of viable spores. It is still unclear whether or not this newly
developed testing protocol would have identified the live Bacillus anthracis had DPG-LSD
utilized it when originally conducting the viability test, or if some unknown scientific
phenomenon allowed the spores to “heal” in the intervening time period. Ultimately, CDC, with
support from DoD, determined that over a 12-year period samples from these 17 lots had been
sent to 194 laboratories in all 50 states, the District of Columbia, three territories and nine
foreign countries.
In response, DoD instituted a variety of measures to safeguard public health, including
directing a 30-day review of the DoD’s safety practices for generating and handling inactivated
Bacillus anthracis. The findings of this 30-day review were documented in a report on 13 July
2015 (Review Committee Report: Inadvertent shipment of live Bacillus anthracis spores by
DoD). On 23 July 2015, DoD issued a moratorium on the shipment of inactivated Bacillus
anthracis. The Secretary of the Army, in an abundance of caution, subsequently directed safety
reviews at all Army laboratories working with Bacillus anthracis and other deadly pathogens.
He expanded the DoD moratorium to include all biological select agents and toxins (not just
1 of 6

 Bacillus anthracis). He also directed the formation of two teams to address this situation. One
team, led by LTG Thomas Spoehr, was tasked to prepare a comprehensive implementation plan
to address the findings and recommendations of the 13 July 2015 DoD report. The second team,
led by MG Paul Ostrowski, was tasked with conducting an investigation, under Army Regulation
15-6, into the facts and circumstances that contributed to the unintended and unacknowledged
shipment of viable Bacillus anthracis spores from DPG-LSD.
The 15-6 investigation team reviewed the reports prepared by the CDC and DoD. The team
developed an investigative plan and visited laboratories at the Edgewood Chemical and
Biological Center (ECBC) and the U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID) to obtain a basic understanding of the science, organizational structure, and
functions at two of the primary facilities working with Bacillus anthracis. From 17-21 August
2015 the team traveled to DPG-LSD to gather evidence. During the evidence gathering process,
the 15-6 investigation team conducted environmental sampling and found contamination outside
of primary containment in one of the laboratories at DPG-LSD. The CDC was notified, and in
response conducted a re-inspection of DPG-LSD on 27-28 August 2015. On 28 August 2015,
CDC suspended the certificate of registration for DPG-LSD to possess, use, and transfer Bacillus
anthracis and directed that all Bacillus anthracis in DPG-LSD’s possession be securely stored to
prevent theft, loss, or release. On 31 August 2015, CDC suspended DPG-LSD’s certificate of
registration for all select agents. The remainder of this Executive Summary focuses on the
findings and recommendations of the 15-6 investigation. All references to DPG and DPG-LSD
leadership and management address only the specific individuals identified in the findings and
recommendations of the 15-6 report of investigation.
Findings: The inadvertent shipment of viable Bacillus anthracis is a serious breach of
regulations, but did not pose a risk to public health. Over the years, significant safeguards
effectively ensured that the inadvertent shipments were not a threat. The preponderance of the
evidence supports a finding that no individual or institution was directly responsible for the
unauthorized shipment of low concentrations of viable Bacillus anthracis. However, several
findings related to scientific, institutional, and individual failures may have been contributing
factors.
Scientific: The 15-6 investigation team identified a number of scientific issues related to the
production, inactivation and post-inactivation viability testing of Bacillus anthracis:
(1) There is a fundamental disconnect between science and regulatory policy. Current
regulations require laboratories possessing even one viable Bacillus anthracis spore to register
with the CDC. Laboratories possessing “non-viable” (i.e., 100% inactivated) Bacillus anthracis
are exempt from this requirement, allowing a greater number of laboratories to work with
Bacillus anthracis. Statistically, the only way to guarantee a sample is non-viable (i.e., contains
zero viable spores) would be to test and consume 100% of the batch or sample. This is not
practical as no material would remain available for use after viability testing. Therefore, the
current regulatory policy doesn’t account for the uncertainty associated with the inactivation
process and impedes research capabilities by imposing an overly stringent, statistically
unattainable requirement.

2 of 6

 (2) There is a lack of scientific research regarding the gamma irradiation inactivation
methods developed for Bacillus anthracis. Data regarding resistance properties of different
strains of Bacillus anthracis to radiation is limited. Furthermore, the irradiation protocols
currently in use were developed using limited datasets for other variables relevant to the
irradiation process, including sample purity/concentration. These gaps in science must be closed
to ensure that irradiation protocols are effective.
(3) There is a lack of scientific research regarding the ability of Bacillus anthracis spores to
repair/heal following irradiation. Previous research supports the theory that Bacillus anthracis
spores may undergo DNA repair following insult (i.e., damage due to gamma irradiation), but the
extent of these repair processes has not been investigated. The 22 May 2015 discovery of a low
concentration of viable spores, and subsequent positive re-test results of lots that had been
irradiated as much as ten years earlier, highlights the potential importance of this gap in scientific
understanding.
(4) There is a lack of scientifically validated and standardized protocols for both the
irradiation of Bacillus anthracis and post-irradiation viability testing. The protocols for
irradiation and viability testing used by each DoD laboratory are different and likely vary in
effectiveness. The CDC viability testing protocol which identified viable spores in 17 of the 33
remaining lots was developed after the 22 May 2015 discovery and is evidence that a
standardized, scientifically validated protocol is necessary.
Institutional: The 15-6 investigation team identified several institutional factors that may
have contributed to the inadvertent shipment of viable Bacillus anthracis:
(1) Funding restraints, competing mission requirements and priorities, and finite resources
present challenges to program and installation managers. Reductions in staff at DPG-LSD
resulted in tasking personnel with additional duties and led to ineffective execution of critical
processes. Management failed to allocate sufficient resources to crucial areas such as quality
assurance/quality control. Additionally, one witness at DPG-LSD voiced a concern that
competition for funding between different organizations/laboratories led to an unwillingness to
collaborate and share information. The preponderance of the evidence does not support this
claim. Although Army laboratories working with select agents receive most of their funding
from the same sources, the work conducted is mostly complementary, not competitive. DPGLSD, for example, is the only laboratory engaged in large scale production for external entities.
(2) The Army and Navy laboratories working with biological select agents and toxins report
to four separate chains of command resulting in inefficient data flow. The lack of unity of
command also resulted in each organization using different procedures and protocols. The
current structural alignment lacks an overall executive agent to provide oversight and to manage
and allocate resources for the DoD biological laboratory enterprise.
(3) Inspections failed to assess critical issues relating to inactivation and viability testing of
Bacillus anthracis, and the frequency and scope of these inspections are insufficient.
Laboratories extensively prepare and tend to curtail select agent operations for announced
inspections. Inspectors examine written procedures and observe laboratory structural/cleanliness
to determine compliance to regulatory policies and procedures. They do not inspect or review
3 of 6

 production protocols. Inspections occur only every two to three years, which may not be
frequent enough to ensure that biological laboratories are operating safely and efficiently. As a
result, the various issues described in the 15-6 investigation report were not uncovered by
previous inspections.
Individual: The 15-6 investigation team found that a preponderance of evidence does not
exist to definitively attribute culpability for the inadvertent shipment of viable Bacillus anthracis
to an individual or group of individuals at DPG. However, the DPG-LSD leaders identified in
the 15-6 investigation report created conditions allowing a culture of complacency to flourish.
As a result, laboratory personnel did not always follow rules, regulations, and procedures.
Certain leadership and oversight staff failed to take appropriate action, and several laboratory
technicians employed questionable laboratory practices. These oversight and laboratory
deficiencies may have been contributing factors, but there is insufficient evidence to establish
any single failure as the proximate cause for the inadvertent shipment.
Despite multiple safety-related incidents and mishaps in the laboratories and involving
shipments to external customers, DPG leadership and DPG-LSD management repeatedly failed
to take action by not conducting internal investigations or determining whether disciplinary
action or re-training was warranted. Instead, DPG leadership and DPG-LSD management
blamed external entities or downplayed the seriousness of the incidents in reports to higher
headquarters.
Personnel at DPG identified in the 15-6 investigation report routinely failed to take
appropriate steps or actions that could have limited the inadvertent shipment of viable Bacillus
anthracis. Examples of these failures include the following: i) failure to investigate and hold
personnel accountable for biological mishaps, ii) failure to hold personnel accountable for poor
laboratory practices, iii) failure to reasonably identify and correct long-standing deficiencies, iv)
failure to adhere to production-based practices, v) failure to account for contamination that could
have introduced viable Bacillus anthracis spores into irradiated samples, vi) failure to execute an
environmental sampling program, vii) failure to maintain a viable video surveillance program,
viii) failure to properly review and approve Critical Reagents Program internal policies and
procedures, ix) failure to integrate the Critical Reagents Program into the DPG-LSD team, x)
failure to ensure biosafety officer qualification, xi) failure to notify the chain of command of
biological mishaps, and xii) failure to safeguard classified information and ensure that personnel
are trained on classification guidance. Additionally, the 15-6 investigation team found evidence
that certain DPG-LSD personnel manipulated and carelessly generated critical documents used
to capture process data and certify the inactivation of Bacillus anthracis (death certificates).
Evidence showed that the culture of complacency existed at DPG-LSD since at least 2008. The
15-6 investigation team cannot definitively state that the inadvertent shipments of viable Bacillus
anthracis could have been prevented if these failures had not occurred due to the scientific gaps
and other institutional issues discussed above.
Recommendations: The 15-6 investigation team identified specific actions the Secretary of the
Army should consider related to the scope of this investigation. These actions include: directing
additional research to address existing gaps in scientific knowledge, making institutional changes
aimed at reducing the overall risk associated with working with biological materials, and holding

4 of 6

 certain personnel at DPG, including the leadership, accountable for their failures to eliminate the
culture of complacency and ultimately prevent additional mishaps from occurring in the future.
Scientific: The investigation team recommends that the Army:
(1) Collaborate with the DoD and the CDC to revise current policy and regulations, including
42 Code of Federal Regulation part 73, to define “Non-Viable Select Agents” and to determine
how to demonstrate non-viability of a select agent. Furthermore, the DoD and CDC should
consider allowing exempted amounts (below an infectious dose) of material to be treated as nonselect agent and consider eliminating or re-categorizing inactivated biological select agents and
toxins to account for the fact that it is not possible to verify that material has been inactivated
with 100% certainty.
(2) Evaluate factors that could affect Bacillus anthracis spore resistance to gamma irradiation,
to include the strain of Bacillus anthracis, the concentration of spores in the solution being
irradiated, the total number of spores being irradiated, and the purity of the spore solution being
irradiated. Conduct carefully controlled studies using varying doses of gamma irradiation in
order to evaluate each of these factors as well as the potential confounding effects of multiple
factors.
(3) Evaluate the potential for gamma irradiated spores to heal. In order for growth to be
detected during viability testing, dormant spores (not killed during irradiation) must germinate to
begin growing. Evidence suggests that time, variance in temperature, salt content, air pressure
and the presence of nutrients may affect germination and healing rates of spores. Studies are
needed to better understand this putative healing phenomenon.
(4) Research viability testing of irradiated Bacillus anthracis spores. An effective Bacillus
anthracis irradiation program requires the establishment of a validated means to assess the
viability of the irradiated spores. In order to ensure that irradiated spores are dead, conditions
should be provided to optimize the opportunity for growth. Factors to evaluate under viability
testing include: length of time spores are incubated in broth and on plates, types of growth
media used for incubation in broth and on plates (tryptic soy agar, brain heart infusion agar,
nutrient broth, etc.), temperature(s) for incubation in broth and on plates, and the portion of the
irradiated sample that should be used for viability testing.
Institutional: The Army should consider taking specific steps in each of the following areas:
uniting command and consolidating facilities dealing with biological select agents; appointing an
executive agent with oversight over DPG-LSD, ECBC and USAMRIID to ensure effective
resource allocation and information sharing amongst the laboratories; directing a mobile training
team to travel to DPG-LSD to improve laboratory processes and procedures by sharing
commonly accepted practices for production facilities; establishing developmental assignments
where all Army laboratories exchange personnel to facilitate collaboration and development of
best practices; ensuring that biological research personnel have appropriate opportunities for
professional development; implementing a formal mentorship program and providing
opportunities to routinely attend conferences to promote professional education and
collaboration; leveraging existing incentive programs to attract and retain highly qualified
scientists to DPG; and working with the CDC to enhance the effectiveness of joint inspections.
5 of 6

 The U.S. Army Test and Evaluation Command should verify that all personnel assigned to
biosafety, biosurety, and scientific positions are qualified and that all mishaps are thoroughly
investigated. The leadership at DPG and DPG-LSD should establish and maintain a quality
control and quality assurance program to monitor and assess all work with biological select
agents and toxins in general and Bacillus anthracis specifically. The DPG and DPG-LSD
leadership should ensure that all standard operating procedures and work instructions governing
operations at DPG-LSD are subjected to a uniform review and approval process.
Individual: The 15-6 report of investigation identifies five leaders (including two former DPG
Commanders) who failed to take appropriate action in response to past mishaps and allowed a
culture of complacency to exist at DPG-LSD. It identifies four personnel who failed to
adequately execute oversight responsibilities and to ensure compliance with DPG protocols and
Army regulations. Finally, it identifies three laboratory technicians who failed to exercise due
care in the performance of their duties. The Army should consider holding these twelve
individuals accountable for their failures.
Summary: The preponderance of the evidence does not support a finding that any individual or
institutional failure was directly responsible for the unauthorized shipment of low concentrations
of viable Bacillus anthracis. However, several scientific knowledge gaps, institutional concerns,
and individual failures may have been contributing factors. Details are provided in the full
report.

6 of 6

 AR 15-6 INVESTIGATION REPORT

INDIVIDUAL AND INSTITUTIONAL ACCOUNTABILITY
FOR THE SHIPMENT OF VIABLE BACILLUS ANTHRACIS
FROM DUGWAY PROVING GROUND

24 JULY 2015 15 DECEMBER 2015

TNVESTIGATING OFFICER
MAJOR GENERAL PAUL A. OSTROWSKI

TABLE OF CONTENTS

 

 

 

 

 

 

 

 

 

A. 15-6 ADMINISTRATIVE INFORMATION I . .  
B. GENERAL BACKGROUND INFORMATION ON BACILLUS 8
C. FACTUAL BACKGROUND PERTAINING To THE 22 MAY 2015 DISCOVERY OF VIABLE BACILLUS

ANTHRACIS  
D. REVIEWS AND INVESTIGATIONS INTO THE 22 MAY 2015 DISCOVERY OF VIABLE BACILLUS ANTHRACISJ 4
E. COMMAND STRUCTURE AND FUNDING OF US. ARMY BIOLOGICAL RESEARCH ..16
F. HISTORICAL MISHAFS AT DUGWAY PROVING GROUND LIFE SCIENCES 
G. POST 22 MAY 2015 EVENTS AT DPG-LSD  .  31
H. INSTITUTIONAL TRENDS AT LIFE SCIENCES DIVISION  16
1. BACKGROUND ON THE INACTIVATION PROCESS OF BACILLUS ANTHRACIS 19
J. RATIONALE AND PROCEDURES FOR 0F BACILLUSANTHRACIS  44
K. PROCEDURES FOR VIABILITY TESTING OF BACILLUS 47
L. BACKGROUND DISCUSSION ON DEATH 49

 

 

 

 

 

A. SCIENTIFIC 50
1. A Fundomentoi Disconnect between Science and Regulatory Policy Regarding Non-viability 100%
lnoctivation) of Bacillus anthracis Before Shipping to Various Loborotories ..50
2. Lack of Research into Gamma Radiation Resistonce Properties and inactivation Methods of Bacillus
anthracis {stroins, spore counts, kill curves) ..51
3. Lock of Reseorch Regording Post-irrodiotion Spore Recovery Theory ..52
4. Lack of Scientifically Validated ond Standardized Pro tocols for pos t-lrradiation Viobility Testing
(incubation Time and Type of Growth Media) ..53

B. .53
1. Perception of Competition for Funding Between US. Army Biological Research Organizations ..53
2. Unity of Command .., ..54
3. Failure to inspect the Technical Aspect of Bacillus onth rocis lnoctivotion ..56

C. INDIVIDUAL ACCOUNTABILITY  59
1. Leodership, Oversight Personnel, and taborotory Technicians Failures and Deficiencies 

a. Manipulation and Carelessness in Generating Bacillus anthracis Death Certi?cates .. 60
b. Failure to Take Action .. 62
c. Complacency .. 85
2. Responsible Party Accountability Findings ..87
a. Senior Leaders at the Army Test and Evaluation Command Headquarters, the Developmental Test Center, and
Dugwav Proving Ground .. 88
b. West Desert Test Center Civilian Leadership .. 96
c. DPG-ISD Leadership .. 98
d. DPG-ISD Oversight Staff .. 105
e. DPG-ISD Laboratory Technicians .. 109
114
A. SCIENTIFIC..  1 I4

 

 

B. INSTITUTIONAL  . 15

 

 

 

1. Army "115

2. Army Test and Evaiuation Command "117

3. Dugway Proving Ground Life Sciences Division 7

C. INDIVIDUAL ACCOUNTABILITY . . . . . . . . . . . . . . . .. .119

IV. CONCLUSION .. 121
APPENDIX A: ENTERPRISE VIEW OF MISHAPS AND PERSONNEL (2003-

PRESENT) .. 122

APPENDIX B: DUGWAY PROVING GROUND ORGANIZATIONAL CHARTS .. 124

APPENDIX C: ARMY BIOLOGICAL LABORATORY FUNDING PROFILES .. 126

APPENDIX D: ACRONYMS .. 131

APPENDIX E: GLOSSARY .. 132

APPENDIX F: TIMELINE .. 134

APPENDIX G: EVIDENCE .. 143

I. Background

On 22 May 2015, a private company noti?ed the Centers for Disease Control and Prevention
(CDC) that it received a specimen of Bacillus anthracis' spores from the US. Army that was
assumed to be inactivated. After testing the specimen of Bacillus anthracis, the private company
veri?ed that the specimen contained a low concentration of live spores.2 The inadvertent transfer
of live Bacillus anthracis failed to follow appropriate regulatory procedures. Upon receipt of
this information, the CDC began an investigation and determined that the Bacillus anthracis
sample, which originated at Dugway Proving Ground Life Sciences Division (DPG-LSD) in
Utah on 20 April 2015 and was routed through the Edgewood Chemical Biological Center
(ECBC) in Maryland, was not fully inactivated and contained a low concentration of viable
Bacillus anthracis spores.3

The specimen of inactivated Bacillus anthracis (lot that was found to contain
viable agent on 22 May 2015 was actually prepared and inactivated via gamma irradiation by
in December of 201 3.5 Immediately following irradiation, viability testing was
conducted and the results indicated that the sample had been properly treated and was safe to
ship, so DPG-LSD prepared a death certi?cate for this lot of inactivated Bacillus anthracis.6
The death certi?cate7 certi?es inactivation/non-viability which in turn exempts the Bacillus
anthracis from the federal regulations that govern work with biological select agents and toxins.8
At this point the sample was moved from the biosafety level-39 laboratory where it had been
grown to a biosafety level-2 laboratory where it could be handled and stored under less
restrictive conditions.10 A total of 300 l-mL vials of lot 667 were prepared? and a
portion of the vials were subsequently shipped to 21 different laboratories, to include both
commercial and US. government facilities.12

 

See Appendix E, Glossary.

2 The number of live/viable spores in the sampIe was low enough to not pose a threat to public health.

3 See Tab D-l Memorandum from the De artment of Health and Human Services, Centers for Disease and

Control Prevention, to E: Entity inspection Report: Life Science Test

Facility (LSTF) (5 June 2015); and Tab D-1.b, Memorandum from the Department of Health and Human Services,

Centers for Disease and Control Prevention, to [Em?Department of Health and Human

Services 010, subject: Life Science Test Facility (Registration 022-1418) (24 July 2015).

4 Lot AGD0001667 was known as Ames Lot 008 internal to DPG-LSD prior to shipment.

5 See Tab B-5.1.d, Enclosure 3, m, DA Form 2823, Sworn Statement (20 Aug. 2015).

6 See Tab C-l9, Death Certi?cate or ot A 0001667 (18 Mar. 2014).

7 The term ?death certi?cate? is used internally at DPG-LSD for the document utilized to indicate and record that a

biological sample has been inactivated. Death certi?cates are not regulatory documents.

3 42 C.F.R. pt. 73.16.

9 Figure I, described below, provides detailed information about biosafety levels.

'0 See Tab B-5.l.g, Enclosure 6. page AM, Sworn Statement (20 Aug. 2015). Notes taken (6)
(6) 2 Jan. 2014 discuss the 300 dead vials and their movement from Room 506 (biosafety leveln3) to the CRP

freezers (biosafety level-2).

Id.

?3 See Tab 027, Daily Report #34, Task Force Anthrax, Joint Program Executive Office for Chemical and

Biological Defense (7 Aug. 2015). Per the standard operating procedure that was in place at the time, viability

testing was not repeated prior to shipping materials after having been in storage.

On 20 April 2015, DPG-LSD shipped samples from lot AGD0001667 (along with other
inactivated pathogens and test materials) to the ECBC. '3 These samples were intended to be
used in a competitive evaluation of diagnostics for the detection of biological threat agents being
deveIOped by six commercial companies. The ECBC provided logistical support to this
competition on behalf of the Critical Reagents Program (CRP) Management Office at Fort
Detrick, Maryland. Since the competitive evaluation was ?blinded? none of the competing
companies were to know what organism was contained in any of the vials that they received), all
identifying markings were removed from each sample and the samples were shipped to the six
companies participating in the competition.M After receiving the shipment, one of the six private
companies involved in the competition checked the viability of the materials they received. '5
This testigg revealed a low concentration of live Bacillus anthracis spores so the CDC was
noti?ed.

As a result of this ?nding, in late May of2015 the CDC notified the Department of Defense
(DOD) of this unauthorized shipment. '7 The CDC and the subsequently investigated DPG-
past history of Bacillus anthracis inactivation. These investigations determined that
between 2004 and 2015, DPG-LSD prepared a total of 86 lots of inactivated Bacillus anthracis
for the As of May 2015, 33 ofthese lots remained in inventory at DPG-LSD. Using a
protocol newly developed by the CDC, '9 DPG-LSD tested the viability of the 33 remaining lots
of Bacillus anthracis and found that 17 of the lots contained low concentrations of viable
spores.20 The CDC, with support item the determined that over a 12 year period, samples
from these 17 lots that contained viable Bacillus anthracis had been sent to 88 primary labs who
then shared it with 106 secondary labs for a total of 194 labs?? As a result of the 
?ndings and in an abundance of caution, the has taken a number of steps to further
safeguard the public, review internal procedures, and determine accountability.22 This

 

'3 See Tab 026, FedEx Order 11211 8 A r. 2015).

'4 See Tab 047, Email RE: W91 (2 Oct. 2015 .
'5 See Tab 032, Solicitation No. W91 (16 Apr. 2015). See also, Tab 13-44. La, page am
DA Form 2823, Sworn Statement (19 Aug. 2015) where she stated ?antigen was being sent as a ?blind? or coded
sample, reading only as to labs who were competing f0r government contracts. Coded samples have to
remove any identifying characteristics that would 1D them as a certain organism. Lot numbers, batch record
numbers, inactivation procedure and dosages would need to be removed since scientists working with the materials
could infer the strain based on their own training and experience.?

'5 See Tab b, Memorandum from the Department of Health and Human Services, Centers for Disease and
Control Prevention, to Department of Health and Human Services 010, subject:
Life Science Test Facility (Registration (24 July 2015).

'7 See Tab 27.1.a, page DA Form 2823, Sworn Statement (19 Aug. 2015); Tab 1.23., page 8-
9, Ronald Fizer, DA Form 2823, Sworn Statement (10 Sept. 2015).

'3 See Tab 027, Daily Report #34, Task Force Anthrax, Joint Program Executive Of?ce for Chemical and
Biological Defense (7 Aug. 2015).

'9 See Tab E-7, Centers for Disease and Control Prevention, Revised Viability Testing Protocol for Samples of
Inactivated Bacillus anthracis (2015).

2? See Tab C-27, Daily RepOrt #34, Task Force Anthrax, Joint Program Executive Of?ce for Chemical and
Biological Defense (7 Aug. 2015).

2' Department of Defense LabOratory Review, 
Review (last visited Sept. 3, 2015).

22 Id.

investigation was ordered to determine whether any individuals and/or institutions are
accountable for the inadvertent shipment of viable Bacillus ai'i'tlzracis.23

This Report of Investigation is the product of the investigation team tasked to conduct a
formal investigation using informal procedures under Army Regulation 15-6, Procedures for
Investigating Of?cers and Boards of Of?cers.

Section I of this report provides a broad background discussion necessary to understand the
findings and recommendations. The background section includes a discussion of the history of
this investigation and related investigations/reviews; the facts and circumstances surrounding the
discovery of Bacillus anthracis Spores in May 2015; an overview of relevant command
Structures; an overview of past biological mishaps24 at a discussion of the observed
trends at and a discussion of the scienti?c procedures used to irradiate and test the
viability of Bacillus anthracis Spores.

Section II discusses the ?ndings of the investigation and documents the facts and
circumstances that may have contributed to the inadvertent shipment of viable Bacillus anthracis
spores. The ?ndings in Section II are broken down into three general areas: Scienti?c,
Institutional, and Individual Accountability. The Scienti?c ?ndings address the knowledge gaps
in science that may have contributed to the inadvertent shipment of viable Bacillus anthracis
including: a fundamental disconnect between science and regulatory policy regarding 100%
inactivation of Bacillus anthracis; the lack of research into gamma radiation resistance properties
of Bacillus anthracis; the lack of research regarding post-irradiation spore recovery theory; and
the lack of scienti?cally validated and standardized protocols for post-irradiation viability
testing. The Institutional portion addresses a number of internal concerns in the Army including
a perceived issue with funding and competition amongst biological research organizations, a lack
of unity of command, and the ef?cacy of inSpections. The Individual Accountability portion
addresses failures and de?ciencies by leadership, oversight personnel, and laboratory technicians
at DPG-LSD. A11 ?ndings are based on a preponderance of the evidence, research, consultation
with experts, and the collective working knowledge and experience of the 15-6 investigation
team.

Section is an outline of actions the and the Army should consider related to the
scope of this investigation. The suggested actions are broken down in three general areas:
Scienti?c, Institutional, and Individual Accountability.

A. 15-6 Administrative Information

On 30 July 2015, the Secretary of the Army directed the Director of the Army Staff to
conduct a full accountability assessment of the responsible institutions and individuals at DPG,
including the chain of command. The Secretary directed the investigating of?cer to conduct an

 

23 See Tab A-l, Memorandum from the Secretary of the Army, to Director of the Army Staff, subject: Appointment
of Army Regulation 15-6 Investigating Of?cer (30 July 2015).

2? For the purposes of this investigation a mishap is defined as a mistake and is not synonymous with a mishap as
de?ned in US. OF ARMY, REG. 385-10, ARMY SAFETY PROGRAM, glossary (27 Nov. 2013) [hereina?er AR
385-10]. See Appendix E, Glossary.

investigation of the speci?c actions at DPG that may have contributed to the unintended and
unacknowledged shipment of viable Bacillus anthracis spores.25 On 30 July 2015, the Director
of the Army Staff appointed Major General Paul A. Ostrowski as the investigating officer.26 The
investigating officer assembled an investigatory team,27 requested and received an extension of
time,28 and conducted the investigation from 30 July 2015 to 15 December 2015.29

In accordance with the Army Regulation 15-6 Appointment Memorandum dated 30 July
20i 5, the Director of the Army Staff defined the scope of the investigation as follows:

a. You are directed to investigate and document the facts and circumstances that
contributed to the unintended and unacknowledged shipment of viable Bacillus
anthracis (anthrax) spores ?'om DPG to a large number of recipients. You will
investigate the actions of all institutions and individuals at DPG, including the
chain of command, which contributed to the inadvertent widespread shipments of
viable anthrax spores.

b. Among other things, investigate the actions taken by individuals who are
responsible for the safe processing and shipping of inactivated anthrax spores.
Determine whether those personnel were aware of the statistical nature of both
anthrax spore inactivation by irradiation and post-inactivation viability testing,

as well as the degree to which DPG was operating outside the parameters of the
available scienti?c data on anthrax inactivation. Assess the reasonableness of the
actions and control measures taken by those personnel with the authority to
prevent unsafe practices and procedures.

c. Additionally, investigate whether DPG kept adequate records, ensured current
procedures were documented correctly, and followed laboratory best practices.
Document in your investigation report any failures in these areas and assess
whether any individuals at DPG reasonably could have prevented the inadvertent
and unacknowledged shipment of viable anthrax spores.

d. Before you begin your investigation, you will review a copy of the investigation
conducted by the Centers for Disease Control and Prevention, as well as Ojj?ice of
the Secretary of Defense 's (08D) Comprehensive Review Report.

e. Your report of investigation should specifically assess whether any institutions
and individuals at DPG should be held accountable for any failures or

 

25 See Tab A-l, Memorandum from the Secretary of the Army, to Director of the Army Staff, subject: Appointment
of Army Regulation 15-6 Investigating Officer (30 July 2015).

36 See Tab A-2, Memorandum from the Director of the Army Staff, to Major General Paul A. Ostrowski, subject:
Appointment as Investigating Officer (30 July 2015).

27 See Tab Memorandum for Record, subject: Special Investigative Team (Aug. 2015).

23 See Tab A-4, MemOrandum from Major General Paul A. Ostrowski, to the Director of the Army Staff, subject:
Extension (Aug. 2015); Tab A-S, MemOrandum from the Director of the Army Staff, to Major General Paul A.
Ostrowski subject: Extension (Aug. 2015).

29 See Appendix F, Timeline.

de?ciencies that may have contributed to unintended and unacknowledged
shipments of viable anthrax spores, and make specific recommendations for
appropriate action. 30

The 15-6 investigation team began by reviewing the investigation conducted by the 
and the 13 July 20 5 DOD Review Committee Report, Inadvertent Shipment of Live Bacillus
anthracis Spores conducted by Dr. Vahid Majidi and his team.32 After reviewing these reports,
the investigation team developed the investigation methodology and visited ECBC, the US.
Medical Research Institute of Infectious Diseases (USAMRIID), and the Joint Program
Executive Of?ce for Chemical and Biological Defense to obtain a basic understanding of the
science, organizational structure, and functions of US. Army biological research commands.33
Interviews and general discussion at ECBC, USAMRIID, and the Joint Program Executive
Of?ce for Chemical and Biological Defense highlighted a number of concerns related to gaps in
science, a lack of communication and cooperation by DPG-LSD personnel, and discrepancies in
documenting the irradiation procedures that in turn assisted in framing the investigation team?s
approach.34 The investigation team proceeded to DPG-LSD where they Spent a week
interviewing witnesses, reviewing laboratory documentation and evidence, and ordering an
environmental sampling of the laboratory due to contamination concerns raised during the
investigation. After returning from DPG-LSD, the investigation team continued to review and
gather evidence, address de?ciencies in the information obtained, drafted a preliminary Report of
Investigation, referred a matter to the Department of the Army Inspector General for further
investigation under the provisions of AR 20-I, and submitted the report for legal review on 9
October 2015.

On 22 October 2015, The Of?ce ofthe Judge Advocate General advised the investigation
team to address Specific comments and questions requiring additional investigation. On 23
October 2015, pursuant to AR 20-I The inspector General authorized the investigating of?cer to
investigate senior army of?cials ?to determine if their failures to take apprOpriate action or
provide appropriate oversight contributed to the unintended and unacknowledged shipment of
viable Bacillus .?35 On 27 October 20l S, the investigating of?cer requested36 and the

 

3? Tab A-2, page 2, Memorandum from the Director of the Army Staff, to Major General Paul A. Ostrowski, subject:
Appointment as Investigating Officer (30 July 2015).
3? See Tab D-lb, Memorandum from the Department of Health and Human Services, Centers for Disease and
Comrol Prevention, to m? Department of Health and Human Services OIG, subject:
Life Science Test Facility (RegistratiOn #C2012l022-l4l8) (24 July 2015).
?2 See Tab D-2, Review Committee Report: Inadvertent Shipment of Live Bacillus anthracis spores by DOD (July
13, 2015).
?3 These organizations were chosen because they also perform work with Bacillus anthracisForm 2823, Sworn Statement? I Aug Tab B-8.I, (6)
DA Form 2823, Sworn tatement (l2 Aug. 2015); Tab (6) DA Form 2823, Swom Statement
(ll Aug. 20l5); Tab B-38.l (6) DA Form 2823, Sworn Statement (2 Sept. 2015); Tab B-43.l, 
DA Form 2823, Sworn Statement (I 7 Sept. 20 I 5).

See Tab A-6, Memorandum from the Inspector General, to Major General Paul A. Ostrowski, subject:
Authorization to Investigate Senior Of?cials (23 Oct. 2015).
3" See Tab A-7, Memorandum from Major General Paul A. Ostrowski, to the Director of the Army Staff, subject:
Extension (27 Oct. 2015).

Director of the Army Staff approved a second 60 day extension. 37 Additionally, the Director of
the Army Staff approved the investigating of?cer?s request for an investigator from Department
of the Army Inspector General?s Of?ce to assist with the investigation of senior army of?cials.3?3
The investigating of?cer examined the involvement of senior army of?cials at the Army Test
and Evaluation Command, the Developmental Test Command, and DPG who served in
leadership roles in these organizations from 2004?2015. After completing 30 additional
interviews and gathering additional evidence, the investigating of?cer ?nalized this Report of
Investigation.

B. General Background Information on Bacillus anthracis

To comprehend the sc0pe and magnitude of this investigation, it is essential to understand the
de?nition of and potential risks associated with Bacillus anthracis. Bacillus anthracis is a large,
aerobic,39 rod-shaped gram positive40 bacterium that is the causative agent of anthrax, a serious
infectious disease that af?icts both human beings and animals. Bacillus anthracis microbes are
non-motile, can form environmentally resistant spores, and are found naturally in soil throughout
the United States and elsewhere in the world. The spores can be spread by skin contact with
infected animal tissue, bites from insects that have been feeding on infected animals, inhalation,
and ingestion of contaminated undercooked meat. inhalation is the most lethal form of
transmission, with a lethal dose in the range of 8,000 50,000 organisms.? Due to the health
risks associated with exposure to Bacillus anthracis, the organism is on the Biological Select
Agents and Toxins list.? While Bacillus anthracis is designated as a Risk Group 2 organism
(moderate individual risk, low community risk) by CDC and National Institutes of Health
Guidelines, biosafety level-3 practices and facilities are recommended for work with Bacillus
anthracfs when dealing with production level (large) quantities or when utilizing aerosol
generating procedures. Figure l, extracted from the Biosa?aty in Microbiological and
Laboratories 5th Edition Manual, summarizes the various aspects of biosafety
levels.

 

37 See Tab A-3, Memorandum from the Director of the Army Staff, to Major General Paul A. Ostrowski, subject:
Request for Second Extension and DAIG Support (27 Oct. 2015).

33 Id.

39 See Appendix E, Glossary.

4? See Appendix E, Glossary. Gram positive strains of bacteria stain purple with violet dye.

4' See Tab Bacillus anthracls - Material Safety Data Sheet (MSDS), 
(last visited 9 Sept. 2015); Friedlander AM, Current Clinical Tepics in infectious
Diseases, Anthrax: clinical features, pathogenesis, and potential biological warfare threat, at vol. 20, pages 335-49
(2000). Samples that are the subject of this investigation were in liquid form not inhalable) and contained
spore counts lower than the lethal dose range.

42 Select Agents and Toxins List, (last visited 22 Sept.
2015).

?13 See Tab E-5, US. Dept. of Health and Human Services, HHS Pub. No. (CDC) 21-1 1 l2, Biosafety in
Microbiological and Biomedical Laboratories, section IV (Dec. 2009) [hereinafter AR 335-10 requires the
mandatory implementation of US. 0F ARMY, PAM 335-69, SAFETY STANDARDS FOR AND
BIOMEDICAL LABORATORIES ch. 1-1 (6 May 2009), (RAR 3 Feb. 2013) [hereinafter DA PAM 335-69] requiring the
Army to follow all national consensus standards including the BM BL.

8

 

ESL

Agents

Practices

Primary Ban-tars and
Safety Eqmpmem

Facilities
[Secondary Barriers}

 

Not known to consistently cause
diseases in healthy adults

Standard mlaobiotoglcat practices

I No primary barriers reqUIreo
I laboratory coats and gloves;
eye, race protection. :5 needed

Laboratory bench and sink requrred

 

I Agents associated with human
disease

I Routes of rnclude per-
cutaneous iniury. ingestion. mucous
membrane exposure

practice plus:

I Limited access

I Biohazard warning signs

I 'snarps' precautions

I Blosalety manual defining any
needed waste decontamin
or medical surveillance polices

Primary barriers:

I 3505 or other physical cmtainment
devices used for all manipulations
of agents that curse splashes or
aerosols or materials

I Laboratory coats, gloves, face
and Median. as needed

ESL-1 plus
I AutorJave available -

 

mamas or exotic agents that may
misc seams or potentially lethal
cisease through the inhalation route or
esposure

practice plus:

I Controlled access

I Decontamination of all waste

I Decontaminatim or laboratory
clothing betore Iauriderhg

Prmy baTiers?

I 8605 or other physical contammenl
dewces used tor at open manipula?
tions of agents

I PPE Protective laboratory clothing.

. lace. and respiratory
needed

ESL-2 plus.

I Physical separation froth access
corridors

I Sed?cioslng. double-door access

I Exnausted air not 

I Negative air?ow into laboratory

 

protedlon. as I Entry through alnock or anteroom
I Hand washing sink near laboratory
exit
4 I Danga'wsiexodc agents which post ESL-3 practices plus: anay rams: ESL-3 111152

W91  risk 0! aerosol-bans-

I 

I Alprocedu?esoonducted i1 Class 

I Separate building or isolated zone

nuttedlaboratoryintectlonSMare I Showeronexn I Dedicatedwppiyandexhaust.
herpenlty I?atatiorwhich thereamno I Mmtenaldeoorrtamimtedm brnatbnwilh ?boosters?stymied. vacuum. and decontamination
vacunes crtreabnems trom facility positive pi'essu'e sun systems

I I anterremirements outlnediri
theiexl
IigBSL?au?ldataareavaitahieto
redesigratemelevel

I 
mu

 

Figure 1: Summary of Recommended Biosafety Levels for Infectious Agents

There are 89 known strains of Bacillus anthracis, all of which exhibit different levels of
pathogenicity (or the ability to cause disease).44 This investigation is focused on the inadvertent
shipment ofthe Ames strain, a particularly virulent (extremely harmful) strain that is well known
for its use in the 2001 attacks (Amerithrax) in which letters containing Bacillus anthracis Amos
spores were mailed to several media outlets and two US. Senators. The pathogenicity of each
strain is related to the presence or absence of two plasmids,45 known as pXOl and The
pXOl plasmid encodes for the anthrax toxin components and the plasmid encodes for a
capsule that allows the organism to shield itself and evade its host?s immune system. In order for
inactivated spores to be the most representative of virulent Bacillus anthrocis, a strain containing
both plasmids Bacillus anthracis Ames strain) is used.46 This is why DPG-LSD and the
Chemical and Biological Defense Program often use the Ames strain when deveIOping
technologies used to combat Bacillus anthracis threats.

 

4? Dcrzelle S, Thierry 8., Genetic diversiol of Bacillus anthracis in Europe: genotyping methods in forensic and
epidemiologic investigations. BIOSECURITY AND BIOTERRORISM: BIODEFENSE STRATEGY, PRACTICE AND SCIENCE,
pages Sl66-76 (2013).

45 See Appendix E, Glossary. A plasmid is a small, circular, double-stranded DNA molecule that is distinct from the
cell?s chromosomal DNA. Plasmids carry genes that can provide bacteria with genetic advantages (for example,
antibiotic resistance) that can render them more harmful or more dif?cult to treat.

46 Pile C, Malone JD, Eitzen EM, Friedlander AM., Anthrax as a potential biological warfare agent, ARCHIVES OF
INTERNAL MEDICINE, pages 429-34 (1998).

C. Factual Background Pertaining to the 22 May 2015 Discovery of Viable Bacillus
anthracis

The maintains a Chemical and Biological Defense Program with the mission to enable
the War?ghter to deter, prevent, protect, mitigate, respond, and recover from chemical,
biological, radiological and nuclear threats and effects as part of a layered, integrated defense.47
The biological portion of this mission addresses both the internal (medical) and external (non-
medical systems) needs of the Wartighter.48 Figure 2 depicts the approach to biological
defense.

 

lute?ma! gate?ma

Environmental
Detection

 

Individual
Protection

   

Collective
Protection

 

 

Diagnostics

., -

Therapeutics Decontamination

   

 

 

 

Figure 2: Approach to Biological Defense

Internal biological defense technologies include:

vaccines and pre-treatments designed to prevent the contraction and/or development
of diseases

diagnostic tools designed to identify pathogens and diseases

- therapeutics that cure and or minimize the impact of diseases after contraction

External biodefense systems include:

- devices capable of detecting and identifying biological warfare agents in the
environment

- individual equipment such as masks and protective clothing

- collective protective equipment that creates safe, protected shelters and vehicle
environments without the need for individual equipment

- decontamination systems designed to return personnel and equipment to service a?er
exposure to biological agents and contaminants

 

47 Chemical and Biological Defense, (last visited 29 Sept. 2015).
43 See Tab Briefing - Shipment oflnactivated Bacillus anthracis (10 June 2015).

10

In support ofthe overarching biological defense mission, the operates four primary
facilities (3 Army, I Navy) that conduct Bacillus anthracis research, development, production,
and testing ofmedical countermeasures and biological defense systems. These facilities are as
follows:

 

Facility Name Acronym Location

 

1. US. Army Medical Research Institute of USAMRIID Fort Detrick, Maryland
Infectious Diseases

 

 

 

2. Edgewood Chemical and Biological ECBC Aberdeen, Maryland
Center

3. Dugway Proving Ground - Life Sciences DPG-LSD Dugway Proving Ground, Utah
Division

4. Naval Medical Research Center NMRC Silver Spring, Maryland

 

 

 

 

 

The USAMRIID, a subordinate ofthe US. Army Medical Command, is the DoD?s lead
laboratory for medical/internal biological defense research. The USAMRIID develops medical
countermeasures such as therapeutics, vaccines, and diagnostics for the bene?t of both military
personnel and the civilian population.49 The ECBC, a subordinate ofthe US. Army Materiel
Command, is the DoD?s principal resource for research and development of non-
medical/external biological detection, protection, and decontamination systems.50 The DPG-
LSD, a subordinate ofthe Army Test and Evaluation Command (ATEC), conducts
developmental and operational testing ofboth medical and non-medical technologies.? The
Naval Medical Research Center (NMRC), a subordinate ofthe Navy Bureau of Medicine 
Surgery, provides health and medical research solutions for the US. Navy/.52 The chains of
command for these four facilities can be seen in Figure 3.

Chief of Staff Chief of Naval
Army Operations

Director Anny

I Staff

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a,
Na Bureau of
Army Materiel Army Medical .
Command Command Madicme and
Surgery
I 
1
Research
Development and Hedlcal Research and Anny Test and
Engineering Materiel Commend Evaluation Command
Comment:
I I 

Edgewood Chemical Dunwey Proving Navy Medical
Blologtcol Center Ground Research Center
IntactIaus Diseases {one} 


 

 

 

 

 

 

Figure 3: Chains of Command for Biological Labs as ofA ugust 2015

 

4" United States Army Medical Research Institute of Infectious Diseases,
(last visited 29 Sept. 2015').

50 Edgewood Chemical Biological Center, (last visited 29 Sept. 20l5).
5' Life Sciences Division, (last visited 29 Sept. 20l5).

52 About NMRC, 

ll

In order to support the testing, development, and sustainment of medical and non-medical
biodefense technologies, the must produce biological reference materials to test its myriad
of biodefense systems. The Critical Reagents Program (CRP), a subordinate of the Joint
Program Executive Of?ce for Chemical and Biological Defense, is the principal resource for
these materials. The CRP. which is managed by a team located at Fort Detrick, Maryland, acts
as a broker for biological materials and measurement/assessment assays produced by the 
labs and industry partners. Figure 4 is a breakdown of the RP product portfolio (lab sources in
parentheses), which is available through its online ordering system known as the Ordering
System for CRP Assays and Reagents.53 As seen in Figure 4, the CRP utilizes DPG-LSD to
produce inactivated anti gens,54 for uni?ed culture collection (strains), ECBC for
genomic material, and NMRC for antibodies.55 The focus of this investigation centers on 
LSD and the production of inactivated antigens, speci?cally Bacillus anthracis.

PRODUCT marrow?
OSCAR (Online Ordering)

- Uni?ed Culture Collection (Strains)
Cf. 

lnactivated Antigen
(CFC)

Antibodies


Genomic material 

 

Figure 4: Critical Reagents Program Product Portfolio and Sources

The use. handling. and transport of biological materials considered to have potential
bioterrorism applications are regulated under the Federal Select Agent Program. The Federal
Select Agent Program implements the requirements imposed by 42 Code of Federal Regulations
(CFR) Part 73. Select Agents and Toxins; 9 CFR Part lZl. Possession, Use, and Transfer of
Select Agents and Toxins; and 7 FR Part 33], Possession. Use, and Transfer of Select Agents
and Toxins. Stringent infrastructure, packaging, transport, and tracking requirements are
imposed on both the sending and receiving entities when a select agent is shipped. As an

 

53 Critical Reagents Program. (last visited 29 Sept. 2015).
5? See Appendix E, Glossary. An assay is a laboratory procedure used to qualitatively assess or quantitatively
measure the presence or amount of something in this case, a biological material or organism. A reagent is a
substance or mixture for use in chemical analysis or other reactions. An antigen is any substance that can provoke
the immune system to create antibodies to work against it.

55 See Tab E-35, CRP Overview Brief. pg. 1 (l Sept. 2015).

12

alternative, certain select agents, including Bacillus anthracis, may ?rst be attenuated
(decreasing their virulence, or ability to cause disease) or inactivated through a variety of means.
Attenuated and inactivated select agents may then be excluded from the select agent regulations,
rendering use, handling and transport of the material a far less complex and costly endeavor.

On 22 May 20l5, a private company noti?ed the CDC that it had received viable (live)
Bacillus anthracis spores in a shipment from This company was participating in a
technical competency assessment for Lateral Flow lmmunoassaysf7 a CRP managed product
whose contract with Detection (see Figure 4) was expiring. The ECBC, which manages the
research and development of Lateral low Immunoassays for the CRP, ordered inactivated
Bacillus anthracis spores along with other inactivated antigens to be used in the assessment from
DPG-LSD through the CRP catalog.58 The DPG-LSD shipped the material, which included
Bacillus anthracis from Lot to ECBC on 20 April 2015.59 This shipment was
excluded from Federal Select Agent Program requirements due to the fact that the material,
including the Bacillus anthracis, was believed to have been inactivated by DPG. Upon receipt,
ECBC repackaged the material in accordance with the requirements of the competency
assessment (which was a blind test, so all identifying markings were removed), and shipped it to
each competitor.60 After receiving the antigens, one private company involved in the
competition chose to do a viability test on the materials it had received and discovered that the
Bacillus anthracis sample contained a low concentration of viable spores.6  Figure 5 depicts the
material and information flow related to the unintended shipment of viable Bacillus anthracis
spores.

 

5?5 See Tab D-la, Memorandum from the Department of Health and Human Services, Centers for Disease and
Control Prevention, to (6) RE: Entity Inspection Report: Life Science Test
Facility (LSTF) (5 June 20l5); and Tab D-lb, Memorandum from the Department of Health and Human Services,
Centers for Disease and Control Prevention, to m? Department of Health and Human
Services OIG, subject: Life Science Test Facility (Registration #C20l 21022-1418) (24 July 2015).

57 Appendix E, Glossary.

58 See Tab C-32, Solicitation No. W91 lQYl5R00l8 (16 Apr. 20l5).

59 See Tab C-26, FedEx Order 1 l21 (8 Apr. 20l5 .

6? See note 58. See also, Tab 8-44. I page snai?- DA Form 2823, Sworn Statement (19 Aug. 2015mm
stated that the ?antigen was being sent as a ?blind? or coded sample, reading only as l? to labs who
were competing for government contracts. Coded samples have to remove any identifying characteristics that would
ID them as a certain organism. Lot numbers, batch record numbers, inactivation procedure and dosages would need
to be removed since scientists working with the materials could infer the strain based on their own training and
experience.?

6? This viability test was not required by regulation. The company chose to conduct the viability test on its own
because it was unsure about the nature of the materials it had received since the samples had been blinded.

l3

 


Joint Program my ml and

Executive Of?ce
EValuauon
for Chemical and Command


Joint Project Dumv Proving

 
 
  
  

LFI Contract
Competitor

  
     
   
         
  

    

 

 

 

 

LFI Contract Management Office
Competitor Medical 
Countermeasures 
Ln Cum-ac: Critical Reagents Catalog Order Life Sciences
Competitor Program Division
(CRP) (ore-L50)

  
 
   
 

LFI Development

 

 
 

Blinded Antigens
(including Bacillus
amhracis)


Notified DC

Figure 5: Biological Material and Information low Related to the 22 May 2015 Discovery

Inactivated Antigens
(including Bacillus
anthracis)

 
   
 

 

 

 

D. Reviews and Investigations into the 22 May 2015 Discovery of Viable Bacillus
anthracis

The discovery of viable Bacillus anthracis spores on 22 May 20l5 prompted multiple
investigations and reviews:

On 26-28 May 2015. a?er being noti?ed of the receipt of viable Bacillus anthracis by the
private company, the CDC Division of Select Agents and Toxins conducted a site visit at the
DPG-LSD. This team?s findings and recommendations were published in an Entity Inspection
Report on 05 June 20l5, and DPG-LSD was ordered to suspend all shipments of Bacillus
anthracis except those supporting the on-going investigation."2 The Division of Select Agents
and Toxins subsequently determined that DPG-LSD was negligent and on 24 July 2015 made a
recommendation to the Department of Health and Human Services, Of?ce of InSpector General
(DHHS-OIG) that a civil penalty be levied.63 A special agent from the Federal Bureau of
investigation was also part of this team. but no criminal actions were identified.64

On 29 May 2015. the Deputy Secretary of Defense directed the Under Secretary of Defense
for Acquisition, Technology Logistics to conduct a 30-day review of the 000?s safety

 

6: See Tab D-la, Memorandum from the Department of Health and Human Services, Centers for Disease and

Control Prevention, to (6) RE: Entity inspection Report: Life Science Test

Facility (LSTF) (5 June 2015).
6" See Tab D-lb, Memorandm ?'om the Department of Health and Human Services. Centers for Disease and

Control Prevention, to (6) Department of Health and Human Services 010, subject:

Life Science Test Facility (Registration lO22?l4l 8) (24 July 20l5).
See note 62.

I4

practices for generating and handling Bacillus anthracis. The review committee published a
report with its ?ndings on 13 July 2015.65

On 30 July 2015, the Secretary of the Army directed the Assistant Secretary of the Army
(Acquisition, Logistics and Technology) to lead a working group, in coordination with the
Department of the Navy, to assess the ?ndings of the report.66 The Director, O?ice of
Business Transformation, Headquarters US. Army Staff, has tasking authority for this
assessment.? Results are pending.

On 30 July 2015, the Secretary of the Army directed the Director of the Army Staff to
appoint an Investigating Of?cer pursuant to Army Regulation 15-6, to conduct a full
accountability assessment of the responsible institutions and individuals at DPG, including the
chain of command.68 This report documents the ?ndings of the 15-6 investigation team.

On 19 August 2015, during a site visit to the DPG-LSD, a member of the 15-6 investigation
team conducted environmental sampling in two laboratories. Evidence of contamination was
found during the environmental sampling.69 The CDC was immediately noti?ed of the
contamination as required by regulation (42 C.F.R. pt. 73.17, Records) and conducted a site visit
and inspection, in coordination with the Department of the Army inspector General, at DPG-
LSD on 27-28 August 2015.70 On 28 August 2015, the CDC noti?ed DPG-LSD that their
certi?cate of registration to possess, use, and transfer select agents and toxins was suspended for
work with Bacillus anthracis.? Subsequently, on 31 August 2015, the CDC noti?ed DPG-LSD
that the suspension of registration had been extended to include work with all select agents and
toxins, not solely Bacillus am?hracz?s.72 On 20 October 2015, the CDC noti?ed DPG-LSD of
several additional ?ndings resulting from the 27-28 August 2015 inspection.73

 

See ?l?ab D-2, Review Committee Repon: Inadvertent Shipment of Live Bacillus anthracis spores by (J 
13, 2015).

66 See Tab D-3a, Memorandum From the Secretary of the Army, to Assistant Secretary of the Army (Acquisition,
Logistics and Technology), subject: Of?ce of the Secretary of Defense Review Committee Report: Inadvertent
Shipment of Live Bacillus anthracis Spores by Department of Defense (30 July 2015).

67 See Tab D~3b, Action Memorandum from the Secretary of the Army for the Deputy Secretary of Defense, subject:
Implementation Plan to Address OSD Review Committee Report: Inadvertent Shipment of Live Bacillus Anthracis
Spores by Findings and Recommendations; Associated Deputy Secretary of Defense Directives; and Related
Executive Agent Responsibilities (13 Aug. 20l5).

68 See Tab A-l Memorandum from the Secretary of the Army, to Director of the Army Staff, subject: Appointment
of Army Regulation 15-6 Investigating Officer (30 July 2015).

69 See Tab DA Form 2823, Sworn Statement (24 Aug. 2015); and Tab 

(6) DA Form 2823, Sworn Statement (27 Aug. 2015).

7? See Tab Memorandum from the Department of Health and Human Services, Centers for Disease Control

and Prevention, to Life Science Test Facility, subject: Re?inspection of Life
Science Test Facility ug. .

7? See Tab Memorandum ?'om the Department of Health and Human Services, Centers for Disease Control

and Prevention, to (6) Life Science Test Facility, subject: Suspension of

Registration: Life Science Test Facility (28 Aug. 2015).

72 See Tab Memorandum from the De artment of Health and Human Services, Centers for Disease Control
and Prevention, to Life Science Test Facility, subject: SuSpension of
Registration: Life Science Test Facility (31 Aug. 2015).

73 See Tab Memorandum from the Department of Health and Human Services, Centers for Disease Control

and Prevention, to_ Life Science Test Facility, subject: Entity inspection Report 

Life Science Test Facility (20 Oct. 2015).
15

E. Command Structure and Funding of U.S. Army Biological Research Organizations

In order to understand the scope and complexity of the issues that contributed to the
inadvertent shipment of viable Bacillus anihracis, it is helpful to understand the pertinent
command structure for the organizations. The Army?s three primary organizations working with
biological select agents and toxins are: DPG-LSD in Utah; the Biosciences Division ofthe
ECBC at Aberdeen Proving Ground, Maryland; and the Science Directorate of the USAMRIID
at Fort Detrick, Maryland.

Although these organizations work with select agents and toxins to accomplish their
missions, and are subject to the same select agent requirements, the organizations are in separate
chains of command due to their specific missions. The chains of command are shown in Figure
6 and described below.

 

U.S. Army Select Agents and Toxins Laboratories
Chain of Command

Chiefof Staff of the Army i 
. Directoroflhe 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


US Army Test and US Army Materiel US Army Medical
Evaluation Command Command Command
I I
. I US Army Research US Army Medical
US ?mg; prawns Development and Research and Materiel
Engineering Command Command
US Army Edgewood US Army Medical
West Desert Test Center Chemical Biological Research Institute of
Center Infectious Diseases
i
Biosciences Division.
I Life Sciences Division Research and Technology Science Directorate
Directorate

 

 

 

 

 

 

 

Figure 6: U.S. Army Select Agents and Toxins Laboratories Chain of Command
1. Chain of Command
a. Life Sciences Division Dugway Proving Ground (DPG-LSD)
The ATEC is the Army?s independent operational test activity and the independent evaluator
for most Army systems.74 ATEC is a Direct Reporting Unit of the United States Army. Its

Commanding General is supervised by the Chiefof Staff ofthe Army; the Director ofthe Army
Staf?f?assists the Chief in supervising ATEC.

 

74 U.S. OF ARMY, REG. 10-87, ARMY COMMANDS, ARMY SERVICE COMPONENT COMMANDS, AND DIRECT
REPORTING UNITS, chapter 20 (4 Sept. 2007) [hereinafter AR 10?87].

16

The ATEC operates through subordinate commands and test centers, including the West
Desert Test Center at US. Army Dugway Proving Ground, Utah. The West Desert Test Center
is the Army?s Major Range and Test Facility Base for chemical and biological defense testing-l5

The West Desert Test Center at DPG has five divisions, one of which is the Life Sciences
Division. The DPG-LSD tests biological defense systems, biosurveillance and medical
countermeasures, and produces biological testing materials. The also conducts work
in support of the Critical Reagents Program.76 The DPG-LSD contains the CRP Antigen
Repository which is staffed by several DPG-LSD Microbiology Branch personnel.? Figure 7
depicts the organization of DPG, including the Life Sciences Division and its branches.13

 

Organization of Dugway Proving Ground

West Desert Test Center

Operations Div

Chemlcal Test Div

     
    

 
    
 
 

   
 

 

           
 
 

Life Sciences Div

   
 

Resource Div

Special DivJ

 
  

  
  

 

 

Br

Regulatory Science
and Innovations Br

Data Div

 

   

  
 

Test Support Div I

 

      

Meteorology Div

 

 

 

Figure 7: Organization of Dugway Proving Ground
b. Biosciences Division, ECBC

The US Army Materiel Command is an Army Command (an organization with an Army?
wide role and multidiscipline functions). Its Commanding General reports to the Chiefof Staff
ofthe Army. The Army Materiel Command is responsible for all aspects ofthe Army?s materiel
readiness.79 One of its subordinate commands is the US. Army Research DeveIOpment and
Engineering Command, which operates through several laboratories and centers, including the

 

75 West Desert Test Center, (last visited 29 Sept. 2015).

?5 The Critical Reagents Program, which is part of the Joint Program Executive Of?ce for Chemical and Biological
Defense portfolio, is managed by a team at Ft. Detrick, Maryland. The CRP utilizes lab space and dedicated
personnel at DPG-LSD to manage its Antigen Repository. The personnel working in the Antigen Repository are
managedfrated by DPG-LSD management, but work only on CRP related projects and often correspond directly
with the management team at Ft. Derrick on CRP related issues.

77 Life Sciences Division, (last visited 29 Sept. 2015).

73 See Appendix B, Dugway Proving Ground Organization Charts.

AR 10-87, chapter 4.

ECBC. The ECBC, located at Aberdeen Proving Ground, Maryland, is responsible for the
acquisition lifecycle for non-medical chemical-biological defense materiei.8?

Within ECBC, the Biosciences Division of the Research and Technology Directorate
conducts research and development of sensor hardware, biological warfare ?eld detection assays,
bioremediation, microbiological testing, and bio-forensic analysis.?

c. Science Directorate, USAMRIID

The US. Army Medical Command is a Direct Reporting Unit of the United States Army.
The Surgeon General is dual-hatted as the Commanding General of the US. Army Medical
Command and is supervised by the Chiefof Staffofthe Army. The US. Army Medical
Command is responsible for all aSpects of medical support to the Army, including biomedical
research and technology.32

The US. Army Medical Research and Materiel Command is a major subordinate command
to the US. Army Medical Command. It is the Army's medical materiel devel0per, with
responsibility for medical research, develOpment, acquisition and medical logistics management.
One of its subordinate commands, the USAMRIID, is the lead medical research laboratory for
the US. Biological Defense Research Program.83 Within the USAMRIID, the Directorate of
Science conducts much of the medical biological defense research for the US. Army, addressing
warfighter protection, disease outbreaks and threats to public health through therapeutics,
vaccines, diagnostics, and information.34

2. Laboratory Funding

The three Army laboratories that produce, handle, test and distribute select agents (Figure 6)
receive resources known as non-reimbursable and reimbursable funds. Non-reimbursable funds,
provided by centralized sources, cover the majority of the overhead and sustainment costs
of DPG and USAMRIID but only a fraction of the costs at ECBC. The centralized funding,
known as defense?wide funds, provide budget stability for critical test facilities and laboratories.
Reimbursable funds are provided by customers for speci?c projects and vary annually,
depending on customer requirements.85 The customer base for the facilities includes, but is not
limited to, various entities in academia and industry, the Defense Threat Reduction Agency, and
the Joint Program Executive Office for Chemical and Biological Defense. While the customer
base that supports the three Army laboratories is rather small, and there is overlap in that some
large programs (including the CRP) provide funding to all three laboratories, each laboratory
supports different parts or phases of the programs so there is no direct competition for

 

8? Edgewood Chemical Biological Center, (last visited 29 Sept. 2015).
8? Biosciences Division, (iast visited 29 Sept. 2015).

82 AR 10?87, chapter 15.

33 United States Army Medical Research Institute of infectious Diseases,
(last visited 29 Sept. 2015).

8? See Tab E-20, USAMRIID Organization and Funding Pro?le

35 Appendix contains graphs depicting the 4 customer baseffunding for each of the three labs

18

reimbursable funding. A detailed breakdown ofthe USAMRIID, ECBC, and funding
pro?les, both reimbursable and non-reimbursable, can be found in Appendix C.

F. Historical Mishaps at Dugway Proving Ground Life Sciences Division

in accordance with the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002,86 the CDC published a list of biological agents and toxins that have the potential to
pose a severe threat to public health and safety. It is Army policy that operations involving these
biological select agents and toxins in the possession or custody of the Army shall be conducted
in a safe and reliable manner. 37 To enhance public con?dence in the Army?s handling of
biological select agents and toxins, it is essential these operations are meticulously planned and
executed. Integral to the safe and reliable custody of biological select agents and toxins
materials, 42 Code of Federal Regulations part 73, Select Agents and Toxins, stipulates that
select agents and toxins are to be transferred from one entity to another only upon authorization
of the CDC.

As part of this investigation, the investigating Of?cer directed a review of past mishaps at
DPG-LSD to provide a background on how DPG-LSD management responded to these issues
and if they implemented lessons learned, enhanced oversight, reporting protocols, re-training and
disciplinary actions. The mishaps considered by the 15?6 investigation team include a series of
eight shipping errors, four of which were reportable to the CDC due to their severity. Three
additional shipping mishaps were not reportable to the CDC, and the remaining shipping error is
still pending CDC reporting determination. The 15-6 investigation team also reviewed an
additional mishap involving inactivation of Bacillus anthracis using an experimental chemical
procegg and subsequent shipment to Lawrence Livermore National Laboratories (LLNL) in
2007. -

Figure 8 provides a summary of mishaps involving biological select agents and toxins
occurring at or involving material originating from DPG-LSD since 2003. In addition to details
about each event, Figure 8 also outlines the personnel occupying key leadership positions during
each event. The intent ofthe ?gure is to establish which key leaders were in place during each
event and to highlight personnel continuity at DPG-LSD.

 

3" See 42 U.S.C. 201, et. seq, 116 STAT. 594, P.L. 107-188.
87 See Tab E-l, U.S. 0F ARMY, REG. 50-1, BIOLOGICAL SURETY para. I-la (28 July 2008) [hereinafter AR 50-



38 Although the root cause of this incident is a matter of debate, it involves potential insuf?cient inactivation

l9

 

2015 I 2014 I

2013

I 2012 I 2011

I 2010

I 2009 I

2008 I 2007 

2006 I 2005 I

2004 I

2003 I 2002

 

DPG-LSD Chief

 

 

MG Peter Utley I

MG Genaro Dellarocco

ls?l

MG Roger Nadeau I

MG James Myles

I MG Robert Armbruster I

 

I orc Merged in 06/11

I l' I Mr.JamesJohnson I

86 Del Turner

Lee Michael Combest I

86 Keith McNamara I

 

I I



COL William King

il

toro- 



 



[tram?1

b? 6)

roto? I



6

 

 

 

 

Dr. James Streilein

Mr. David Jimenez

Mr. Michael Etzinger

 

 

 

CDC reportable; lines pending

Events Iiune 2013 June 2015 June 2011 - June 2013 June 2N9 - June 2011 June - June 2009 June 2005 ?June 2007 June 2003 June 2005
Bacillus an thracis (B. anthracis) 03/14 Lot 1667 10/07 Lot 0999 W06 Lots 0794, 0798, (310 01/04 Lots 0m, 0070
inactivation with subsequent 09/14 Lot 1631 08/08 Lot 1039 06/06 Lot (822 ill/04 Lots 051], 0516
[growth (all lot numbers begin with Date unknown tot 1727 05/09 Lot 1151 100/06 Lot (362

AGDOW) 10/06 Lot 0910

 

Possible shipment oi viable
Venezuelan Equine Encephalitis
wrus (VEE) as attenuated Virus
CDC reportabillty not yet
determined

00/15 CDC investigation of ECBC and
USAMRIID includes VEE status as
select agent

05/12 DPG-LSD ships VEE to one
private company

02/13 DPG-LSD asks USAMRIID about
VEE inactivation

9/10 asks CDC about VEE
inactivation

08/06 DPG-LSD ships VEE to ECBC
and two private companies

DPG-LSD ships VEE to Armed
Forces institute of Pathology and
private company

21213-2004(date unknown) DPG-LSD
receives VEE from DPG-
LSD believes it Is inactivated

03/05 CDC adds VEE to select agent
list

 

Non-exempt Botulinum toxm
shipped to ECBC and NMRC as
exempt from CDC Select Agent
requirements

CDC reportable; lines assessed

11/11 DHHS declines to impose
monetary penalty on 

10/10and 11/10 DPG-LSD ships
incorrect quantity of Botulinum
toxin to ECBC. NMRC

01/11 NMRC discovers and reports
error

05/11 DAIG inspection fails 
for shipping errors

06/11 CDC sends investigation
report to 

02/08 ships incorrect
quantity of Botulinum toxin to ECBC

 

incompletely inactivated 8.
onthracis shipped to loilowing
chlorine dioxide (CIOZ) inactivation
CDC reportable; lines assessed

06/09 CDC sends investigation
report to DPS-LSD

deciines to impose
monetary penalty on DPG-LSD

ships C102-
inactivated B. onthracis to LLNL
05/07 finds growth, reports to
CDC

 

Shipping errors
reportable

 

[04/14 DPG-LSD sends mislabelcd
inactivated B. anthracis and Yersinr'a
pestr?s to Republic of Korea

DPG-LSD sends mislabeled
Vaccinia lo NSWC

 

 

07/10 DPS-LSD shipments
oi inactivated agents between
NSWC and a private company
12/10 DPG-ISD sends NSWC
mlslabelled Buikho/den'a molier'

 

 

 

 

 

Figure 8: Summary of Historical Mishaps and Key Personnel

20

 

1. Lawrence Livennore National Laboratories (2007-2010)

In April 2007, DPG-LSD shipped select agent Bacillus anthracis that it had attempted to
chemically inactivate with chlorine dioxide to Lawrence Liverrnore National Laboratories
(LLN L) in Livermore, California. The LLNL performed viability testing on the agent after
receipt and identi?ed a single viable Bacillus anthracis spore, implying that DPG-LSD had made
an unauthorized shipment of select agent. The LLNL noti?ed the CDC of the presence of the
single viable Spore on 26 April 2007, and the CDC subsequently noti?ed DPG-LSD of the
unauthorized shipment on 2 May 2007.89 The DPG-LSD subsequently submitted three
responses to the CDC in May of 2007 providing details on the inactivation and viability testing
processes that were utilized, including relevant laboratory notebooks and Standard Operating
Procedures. In November of 2007, the CDC provided recommendations to to
improve their processes moving forward and referred their investigation to the Duns-010.90
On 3  March 2008, the DHHS-OIG notified the that
it had preliminarily determined that DPG-LSD violated federal regulations by shipping viable
Bacillus and requested a response from by 1 May 2008.93

The DHHS-OIG, in consultation with the Division of Select Agents and Toxins,
determined that although the method of inactivation (vaporous chlorine dioxide) was
scienti?cally acceptable,94 DPG-LSD did not follow its own standard operating procedures to
inactivate and test the viability of Bacillus anthracis. The CDC investigation included a
comprehensive review of documentation concerning the inactivation procedure,
including a copy of the relevant standard operating procedure the principal
investigator?s clinical notebook, the inactivation certi?cate for the sample, and the viability test
record. It was found that during the time in question, covered three acceptable
methods for inactivating bacteria: heat, formalin (37% formaldehyde in liquid solution form),
and gamma irradiation. It did not cover the use of chlorine dioxide.95 The investigation also

 

8" (5)

6 Testimony from these leaders indicates that they were aware of the
LLNL incident at the time and were supporting DPG-LSD personnel in providing evidence to the CDC in response
to their inquiries. Although there is no evidence that either of them initiated a commander?s inquiry or [5-6
Investigation, this is reasonable based on the fact that the CDC was still gathering facts and no fomtal ?ndings had
yet been submitted. See Tab 3-46. I (6) Memorandum for Record, subject: Summarized

Testimony of 5 6 (26 Oct. 2015); Tab B-51.l, (6)
Memorandum or Record, subject: Summarized Testimony of (6) retired)m-28 Oct. 2015).

9? The l5-6 investigation team found no evidence indicating that DPG-LSD was noti?ed that the CDC investigation
had been referred to the Department of Health and Human Services, O?ice of Inspector General. 
assumed that the matter was closed as of 16 November 2007.

This noti?cation was mistakenly addressed to (6) (6)

92 See 42 U.S.pg. 59, LLNL Correspondence and Evidence.

9" See Tab 041, pg. 57, LLNL Correspondence and Evidence.

95 covers both inactivation and viability/sterility testing. While 47 does not contain
procedures for using chlorine dioxide, the viability testing procedures it contains were still considered valid because
they are organism speci?c and not dependent on inactivation method. This standard operating procedure was
violated when the decision was made to destroy only the single vial that was ?cloudy with contamination? and to
ship the other vials, even though all of the material came from the same treated batch.

2]

found that DPG-LSD did not test the chlorine dioxide inactivation method for ef?cacy prior to
implementation.96

According to the CDC, the principal investigator?s clinical notebook demonstrated that
during viability testing, one of the ?ve tubes that was to be shipped to Lawrence Livermore
National Laboratories tested positive for viable Bacillus anthracis (all ?ve tubes were originally
tested), when a small portion was cultured in a brain-heart infusion broth. The CDC determined
that this was evidence that the inactivation procedure was inefTective. The CDC found that the
principal investigator?s notes did not explain why the viable colony grew, whether the
inactivation procedure was performed properly, or why the four remaining tubes were not
retested for viability alter a single tube failed the original viability testing.97 Upon completion of
the viability check, DPG-LSD destroyed the tube with excessive growth via autoclave, issued
death certi?cates for the four remaining tubes and shipped them to LLNL. The Bacillus
anthracis samples provided by to LLNL were of the MLVA-IS Ames strain
genotype, which was the same as the viable Bacillus anthracis identi?ed at LLNL.98

After receiving noti?cation from on 31 March 2008 of the preliminary ?nding
that DPG-LSD was the source of contamination, (6) ubmitted two responses to the
DHHS-OIG dated 28 April 2008 and 1 May 2008 respectively containing information compiled
by the DPG-LSD The responses refuted the CDC ?nding that DPG-LSD was the source
of contamination and stated that the single viable spore likely originated in the laboratory at

LLNL. The responses from (6) did not consider or address the tube that failed during
the original viability test. There was no evidence that (5) irected a commander?s

inquiry or 15-6 Investigation to resolve the inconsistencies/disagreement between the ?ndings of
the and those of the staff. He relied on the staff at DPG-LSD to
review themselves. ?00

There was no additional correspondence on the matter until 2 December 2009 when the
DHHS-OIG concluded its investigation and noti?ed the DPG Commander (at this time Colonel
William King) that it had violated 42 Code of Federal Regulations Part 73.16 by making an
unauthorized shipment of the biological select agent Bacillus anthracz?s to LLNL without
obtaining pretransfer authorizatiOn from the CDC. This noti?cation from the was

 

9? See generally Tab C-4l, LLNI. Correspondence and Evidence.

?7 It was also found that during processing of this batch, two vials of material were broken while in a centri?ige.

The batch was originally spread throughout 60 vials alter being treated with the chlorine dioxide. These 60 vials
were combined into 12 vials prior to being centrifuged. Two of these 12 vials were broken in the centri?ige, leaving
ten vials remaining. These ten vials were then combined into the ?nal ?ve vials that were tested for viability. There
was no concern that the broken vials repreSented a release of agent because the material had already been
inactivated, but they are another potential source for contamination at DPG-LSD.

9" Id.

99 The response was coordinated by the (6)

'00 Id. See also Tab 8-49. I, Memorandum for Record sub?ect: Summarized Testimon

    
 

See Tab C-41, pgs. 70-72, LLNL Correspondence and Evidence. Note: the CDC conducts investigations on
behalf of the Department of lealth and Human Services and the Of?ce of Inspector General reviews ?ndings and
adjudicates corrective action, which may include monetary penalties.

22

consistent with the preliminary ?ndings and considered ?nal with no expected formal response
from DPG-LSD.

In addition to ?nding DPG-LSD responsible for the incident, the DHHS-OIG also
determined that, under the Public Health Security and Bioterrorism Preparedness and Response
Act, '02 a civil monetary penalty of up to $250,000 against an individual and up to $500,000
against any other person, including any entity that was in violation of any of the requirements
found in the select agent regulations was authorized. ?03 Based on all of the circumstances,
including status as a Federal agency, the DHHS-OIG declined to enforce a civil
monetary penalty. However, the DHHS-OIG stated that DPG-LSD should examine its current
practices and policies, implement effective corrective actions and safeguards to ensure that future
violations did not occur, and monitor such actions and safeguards on an on-going basis.'04

In response to the 2 December 2009 notification, Colonel King directed 05 to
?prepare a response and discussion? summarizing the LINK, incident. '06 provided
Colonel King with an email detailing the historical facts associated with the incident (which at
this point had been on-going for more than two years) and a PowerPoint presentation that
reinforced the idea that the contamination must have originated at LLNL. ?07 Similar to the
responses sent by DPG-LSD to the CDC in 2008, the responses from failed to
address the single tube that failed the original viability test. Colonel King testi?ed that he
directed a commander?s inquiry into the LLNL incident to be led by the DPG Safety Of?ce. '03
However, review of correspondence from that timeframe and interviews with witnesses at DPG
indicate that the ?response and discussion? provided by (6) was ail that he
requested. ?09 (6) also drafted a written reSponse to the dated 21 January
2010 which reiterated the DPG-LSD stance that the contamination originated at LLN L. '0
Colonel King testi?ed that he reviewed this response and sent it to the with a signed
cover letter. There is no evidence of this signed cover letter and the has no record

 

'02 see 42 U.S.C. 201, et. seq, 116 594, P.L. 107-188.

Enhanced Control of Dangerous Biological Agents and Toxins, 42 U.S.C. Part 262a( and Civil Money

Penalties, 42 C.F.R. pt. 73.2].

See Tab C?4l, . 71 LLNL Corres ondence and Evidence.

IOS

'06 See Tab C?4l, pg. 81, LLNL Correspondence and Evidence.

'07 See 'l?ab C-41, pgs. 73-80, LLNL Correspondence and Evidence. (6) did not provide Colonel King

with historical correspondence regarding the matter.

'03 See Tab B-23.2, (6) Memorandum for Record, subject: Transcribed Testimony of

Brigadier General William King (Former Commander of Dugway Proving Ground from July 2009 to Juiy 201 I) (I0

Nov. 2015).

?09 See Tab 8-2.2, (6) Memorandum for Record, subject: Transcribed Testimony of (6)
(6) 12 Nov. 2015); Tab for Record, subject:
Summarized Testimony 0f_( 2 NOV-



2015 Tab 8-68.] (6) Memorandum for Record sub'ect: Summarized Testimony of

      
  

      
 

"0 See Tab 041, pg. 82, LLNL Correspondence and Evidence.

See Tab B-23.2, (6) Memorandum for Record, subject: Transcribed Testimony of
Brigadier General William King (Former Commander of Dugway Proving Ground from July 2009 to July 201 l) (10
Nov. 2015).

23

of receiving the reSponse.1 ?2 Review of email correspondence from this timeframe indicates that
the reSponse memorandum was in the review process until at least April 2010. There is no
evidence that it was ever signed and transmitted. '3

Other than his testimony, there is no evidence that Colonel King directed a commander?s
inquiry or 156 Investigation to resolve the inconsistencies/disagreement between the ?ndings of
the and those ofthe DPG-LSD staff. '4 Review of the evidence indicates that
(6) simply repackaged the information gathered for (6) in 2008. In Spite of
the fact that the CDC and DHHS-OIG ?ndings were now considered final 1 '5 and that a civil
monetary penalty was authorized, no individual at DPG-LSD was formally disciplined in
response to this mishap.

2. Naval Surface Warfare Center (2010)

In July 2010, the Naval Surface Warfare Center (NSWC) in Dahlgren, Virginia received a
shipment from DPG-LSD containing Venezuelan Equine Encephalitis TC83 in lieu of Bacillus
anthracis (Sterne strain) it had ordered from the CRP. The Bacillus anthracis Sterne had
inadvertently been sent to ICX Biosystems, a private laboratory at La Jolla, California. 1CX
Biosystems had been expecting the Venezuelan Equine Encephalitis TC83 shipment. Neither the
Venezuelan Equine Encephalitis TC83 strain nor the Bacillus anthracis (Sterne strain) are select
agents, so this mishap was not reportable to the CDC. Both shipments had been packaged at the
same time and had been shipped to the wrong customers. The NSWC contacted the CRP

  
  

 

The NSWC destroyed the vial of Venezuelan
Equine Encephalitis TC83 and DPG-LSD sent the Bacillus anthracis Sterne that was original
ordered}16 and (6) reported
this mishap to their supervisor (6) but reporting stopped at (6)
level. i ?7 Due to the initial and continued failure to report this event the chain of command was
unable to investigate this mishap or take disciplinary actions. The DPG-LSD leadership is

    

 

Memorandum for Record, subject: Summarized Testimony of (6)

 
     

See Tab C-4l, pg. 97, LLNL Correspondence and Evidence.
"4 Note: the (6) The evidence
indicates that (6) was engaged in the response to the LLNL incident in a support role, but since the
Commander of DPG (Colonel King) was engaged directly, (6) was not responsible for the response.

?5 See Tab 8-2.2, pg. 10, m? Memorandum for Record, subject: Transcribed Testimony of
(12 Nov. 2015). DPG-LSD understood that this determination was ?nal. The January 2010
response was dra ted in an effort to fomially document their continued disagreement with the CDCIDHHS-OIG
finding.

?6 See Tab B?44.2.d, Enclosure 3, page 2 to Form 2823, Sworn Statement (20 Aug. 2015); Tab B-
442a, page 8, Mia-Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015). The Bacillus
anthracis Sterne received by [Eta?was aiso destroyed.

"7 See Tab B-2.l page 4, ?am, DA Form 2823, Swom Statement (21 Aug. 2015) (6) does
not mention this mishap when summarizing past incidents in his statement, indicating he was unaware; Tab B-27.2a,
page 7, m, DA Form 2823, Sworn Statement (20 Aug 2015) states (6) did keep me updated
on her progress as she worked to resolve each incident which she did."

24

shown in Figure 8 above, and in Appendix A, Enterprise View of Mishaps and Personnel (2003
present). 1 '8

3. Three Brroneous Shipments of Botulinum neurotoxin A

On three se arate occasions 27 Februa 2008 20 and 17 November 20l0),
19 inadvertently shipped

regulated quantities of Botuiinum neurotoxin A to two separate entities. Quantities of Botulinum
neurotoxin less than 0.5 mg total mass are exempt from the federal select agents and toxins

list. '20 believed the shipments contained O.l mg vials of Botulinum neurotoxin A,
but the shipments contained 1.0 mg vials (a non-exempt quantity which requires handling as a
select agent/toxin) due to errors made retrieving the vials from storage. 

Two of the erroneous shipments of Botulinum neurotoxin A were sent by DPG-LSD to
ECBC located at Aberdeen Proving Ground, Maryland. One was sent on 27 February 2008 and
the other was sent on 20 October 2010. Both of these shipments contained 1 mg/ml of
Botulinum neurotoxin A (a regulated concentration), but the shipping documentation for each
shipment indicated that the concentration was 0.1 mg/ml (an exempt concentration). The ECBC
did not notice these discrepancies upon receipt.122

A third erroneous shipment of Botulinum neurotoxin A was sent from DPG-LSD to NMRC
located in Forest Glen, Maryland On 17 November 20l0. Similar to the shipments to ECBC, this
shipment contained 1 mg/ml ofBotulinum neurotoxin A (a regulated concentration) but the
transfer documentation re?ected 0.1 mg/ml (an exempt concentration). As with the 2008 and
2010 ECBC transfers, NMRC did not immediately notice that the vial received did not match the
transfer documentation. The NMRC noticed the shipping error on 28 April 201 and noti?ed
DPG-LSD, ?ve months after the shipment was received. The DPG-LSD then immediately
noti?ed the CDC of the shipping error in a memorandum which also outlined corrective actions
implemented to prevent similar shipping errors in the future. '23

The DPG-LSD then conducted a search of their historical shipping database and discovered
the earlier shipments to ECBC. The DPG-LSD notified the CDC of these two additional
erroneous shipments in a memorandum dated 2 May 20] l. The CDC responded to DPG-LSD
and requested additional information about their inventory and database processes on 31 May
201 l. The DPG-LSD provided the requested additional information on 8 June 201 i. The CDC
acknowledged receipt of this additional information in a memorandum dated 16 June 20] and
referred the matter to the Dims-010.124

 

"3 Figure 8 and Appendix A were used as tools to determine who knew, or should have known, about the various

misha and track the actions that were taken in response.
"ma?a-ms had numerous titles relating to storage and shipping during her tenure at DPG-LSD.

See HHS Select Agents and Toxins, 42 C.F.R. pt. 73.3

See Tab C-42, pg. 4, Bot A Correspondence and Evidence.

'22 Id.

'23 See Tab C-42, pg. l, Bot A Correspondence and Evidence. The evidence indicates that (6)
and Colonel King were all aware of this incident shortly after the initial noti?cation was received.
See Tab 042, pgs. 3-16, Bot A Correspondence and Evidence.

25

On 3 November 20l l, the DHHS-OIG issued its ?nding against DPG-LSD stating that the
transfers of Botuiinum neurotoxin A were unauthorized because DPG-LSD did not meet
exemption requirements and did not obtain CDC authorization prior to transfer in accordance
with 42 CFR Part 73.3 (HHS Select Agents and Toxins) and Part 73.16 (Transfers). Due to the
severity of these shipping discrepancies, the was authorized to impose a civil
monetary penalty of up to $250,000 against an individual and up to $500,000 against any other
person/entity. However, since DPG-LSD is a government entity DHHS-OIG chose not to
enforce the penalty. A penalty could have been levied separately for each of the three individual
Botulinum neurotoxin A shipments. 125

The DHHS-OIG recommended DPG-LSD examine its policies and procedures and implement
corrective actions to prevent future improper shipments. '26 The causes of the three Botulinum
neurotoxin A shipping mishaps were: (1) storing 1 mi vials having 1 mg/ml and 0.1 mg/ml
concentrations together on the same shelf; (2) allowing these vials to have the same lot number
and tracking number; (3) improper verification that the concentration requested (0.1 mg/ml)
matched the concentration of the label on the vial pulled from storage (1 mg/ml); and (4) no
established system of oversight to prevent human error. '27 As corrective actions, DPG-LSD
physically separated vials containing various concentrations of Botulinum neurotoxin A,
relabeled all vials with distinct lot/tracking numbers (by concentration), and instituted a two-
person verification process prior to shipment. '28

The Department of Army Inspector General (DAIG) and CDC were scheduled to conduct a
joint Biological Surety/Select Agents Inspection of DPG-LSD from 9-13 May 201 l.
Coincidentally, this joint inSpection was conducted concurrent to the initial notification and
correspondence regarding the erroneous Botulinum neurotoxin A shipments. Because the
erroneous shipments represented a violation of Army biological surety regulations, a failing
de?ciency was assigned against DPG-LSD by the DAIG. During the inspection out-brief,
Colonel William King non-concurred with the failing de?ciency based on an incorrect
interpretation of and Department of Transportation regulations. ?29 The DAIG did not
accept Colonel King?s non-concurrence, and formalized the failing de?ciency in their report on
29 June 2011.'30

The DPG Commander, Colonel William King, ensured that DPG-LSD implemented remedial
measures to prevent future shipping errors similar to the Botulinum neurotoxin A errors.
However, Colonel King did not initiate either a commander?s inquiry or a 15-6 investigation
based on either the [3 May 20] de-brief or the 29 June 2011 DAIG signed memorandum. 13?

 

'35 See Tab 042, pg. 22, Bot A CorreSpondence and Evidence.

IZO 

'27 See Tab C-36, DAIG 201 I, para. 2-1.

'23 See Tab C-42, pg. I, Bet A Correspondence and Evidence.

'29 See Tab (3-36, DAIG 351 2011, para. 2-1.

'30 Id. The 381 report executive summary states that the observations and de?ciencies were also briefed to AT EC
leadership.

See Tab B-23.l.a, page 6, 80 William King, Addendum to DA Form 2823, Sworn Statement (25 Sept. 2015);
Tab page 2, Email from {lam?to (6) Subject: 15-6 (30 Sept. 2015). Note: 30 King
claimed that he initiated an inquiry in his sworn statement, but no documentary evidence could be found to support
this claim.

26

There is no evidence that any individual at DPG-LSD was formally disciplined in response to the
shipping errors despite the fact that the errors resulted in a failed DAIG inspection and heavy
civil penalties could have been imposed by the 

On 13 June 2011, Colonel King sent an email to leaders at ATEC and the Developmental Test
Command (DTC) downplaying the seriousness of the shipping errors to his commanders:

It appears as reported earlier that CDC does not see the incident as serious as
HQDA IG does and as previously reported is very comfortable with our reporting
and immediate actions taken to address the circumstances to ensure it does not
happen again. 

This quote is in reference to the 3] May 201 memorandum from the CDC.133 The [5-6
investigation team reviewed this memorandum and interviewed associated personnel from the
CDC and concluded that the evidence shows that the CDC considered this to be a serious
incident, whereas Colonel King clearly did not. This is further supported by the decision
to refer the matter to the 

4. Naval Surface Warfare Center Shipment of Burkholderia mallei (20l0)

In December 2010, the Naval Surface Warfare Center (NSWC), received a shipment from
DPG-LSD of inactivated Burkholderia mallei that had an incorrect lot number on the vials (extra
digit was inserted), thereby not matching the enclosed death certi?cate, the accompanying

certi?cate of anal sis or the shi in documentation. The NSWC contacted the
wt DPG-LSD who told them to simply change the label.
The NSWC declined to do that, so DPG-LSD sent a new death certi?cate, a new Certi?cate of
Analysis, and new vial labels. However, DPG-LSD committed two additional errors in the
course of this second shipment. First, the new Certi?cate of Analysis did not have correct
concentration and genomic equivalent values. Second, the corrected labels had a different
aliquot number. When NSWC questioned DPG-LSD about the different aliquot number on the

new labels, DPG-LSD told them since all vials were from the same batch lot, the aliquot number
was irrelevant. '34 The NSWC accepted this explanation and used the material as planned.

      
 
 

(6) noti?ed the Joint Program Executive Of?ce for Chemical and Biological Defense,
CRP management of?ce of actions she took, but she did not re ort the incident to the DPG-LSD
chain ofcommand. '35 the DPG-LSD Whalso did not
report this incident to the DPG-LSD chain of command. There was no formal reporting of this
event, therefore the chain of command was unable to investigate this mishap or take disciplinary

actions. The DPG-LSD leadership is shown in Figure 8 above, and in Appendix A, Enterprise
View ofMishaps and Personnel (2003 present).

 

'32 See Tab C-42, pg. 12, Bot A Correspondence and Evidence.

'33 See Tab 042, pg. 6, Bot A Conespondence and Evidence.

See Tab B-44.2.d, Enclosure 3, page 2 to (5) DA Form 2823, Sworn Statement (20 Aug. 20l5). This
incident was not CDC reportable due to its administrative nature.

?35 See Tab B-44.2a, page 8, (6) Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015).

27

5. Naval Surface Warfare Center Shipment of Vaccinia (2014)

In September 2014, a shipment of inactivated Vaccinia from DPG-LSD to Naval Surface
Warfare Center (NSWC) was mislabeled with an incorrect lot number and ?Live? Vaccim'a
nomenclature. '36 Viable Vaccinia virus is a research tool used in a variety of biomedical
applications but it can be a human pathogen, making the live strain a Risk Grou 2 or anism. '37
Theginactivated Vaccinia had been procured from a commercial vendor. Wk

removed the commercial vendor labels from 17 vials and replaced
them with DPG-LSD CRP labels that indicated viable Vaccinia, lot number AGD0000182. The
correct label should have been inactivated Vaccim'a, lot number AGD0000219. Two different
DPG-LSD personnel failed to detect that the incorrect lot number was being shipped, '38 despite

earlier ?ndings and retraining implemented by the DPG-LSD leadership to ensure these types of
mishaps did not continue to occur. '39

Two of the seventeen vials were sent by the NSWC to the Midwest Research Institute in
January 2015 where the labeling mistake was discovered. The NSWC noti?ed one of the Joint
Pro ram Executive Of?ce-Chemical Biological Defense, (6)

wand DPG-LSD . Upon noti?cation, the DPS-LSD recalled the vials

remaining in inventory at NSWC, re-labeled them to re?ect the correct information and returned

them to the NSWC in Januar 2015.?40 Neither (6) nor
reported this mishap through the DPG-LSD chain of command. '41
DPG-LSD did not initiate an internal investigation or take any formal disciplinary actions related

to this mishap. The leadership at the time of this incident is shown in Figure 8 above, and in
Appendix A, Enterprise View of Mishaps and Personnel (2003 present).

 

6. ECBC and Shipment of Venezuelan Equine Encephalitis (2003-2004)

On 25 August 2015, as patt ofan ongoing CDC investigation at ECBC and a
potential incident was identi?ed in which DPG-LSD may have improperly shipped Venezuelan
Equine Encephalitis virus as a non-select agent not a biological select agent and toxin). '43
Sometime during 2003-2004, shipped Venezuelan Equine Encephalitis virus to
DPG-LSD. At the time of this shipment Venezuelan Equine Encephalitis virus was not

 

'36 See Tab 3-44.23, page 8, (6) Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015).

'37 See Tab 15-5, BMBL, section 11, Table 1, Classification of Infectious Microorganisms by Risk Group.

'33 See Tab 13-] 0, Critical Reagents Program, Corrective Action Report (CAR) Form (13 Jan. 201 S).

"9 See Tab (3-42, pg. 1, Bot A CorreSpondence and Evidence.

"0 See Tab B-44.2.d, Enclosure Form 2823, Sworn Statement (20 Aug. 2015).
See Tab 3?44.23, page 8,WAddendum to DA Form 2823, Sworn Statement (20 Aug. 2015).

"2 See Tab E-32, Memorandum from the Department of Health and Human Services, Centers for Disease Control
and Prevention, to_ us. Army Medical Research Institute oflnfection
Diseases, RE: Re-lnspection of US. Army Medical Research Institute of Infection Diseases (21 Aug. 2015).

"3 See Tab C-48, Email from MG Daniel L. Karbler, to LTG Gary H. Cheek Subject: Fw: Regulatory violations
likely (15 Sept. 2015). See also Tab 049 Spreadsheet with VEE Details (15 Sept. 2015).

28

considered a Biological Select Agent and Toxin."M However, on 18 March 2005, the CDC
added Venezuelan Equine Encephalitis virus to the list of biological select agents and toxins. ?5

Between 2006 and 2012 DPG-LSD shipped what they believed were inactivated killed)
samples of this Venezuelan Equine Encephalitis virus to two US. Government laboratories
(ECBC and the Armed Forces Institute of Pathology) and four commercial laboratories.M6 In
2010, DPG-LSD questioned whether this inactivated Venezuelan Equine Encephalitis virus
should be considered a biological select agent and reached out to the CDC for an answer. The
wanted to know whether it could ship inactivated Venezuelan Equine Encephalitis
without the Form 2, Request to Transfer Select Agents and Toxins, required for Biological Select
Agents and Toxins and whether it could be shipped to a non-registered facility. The CDC
indicated that if the Venezuelan Equine Encephalitis was not viable it would not fall under the
Federal Select Agent Program, but also stated that it was up to DPG-LSD to determine whether it
was viable or not. ?47

In February 2013, DPG-LSD reached out to USAMRIID to ask whether the inactivated
Venezuelan Equine Encephalitis that USAMRIID sent in 2003-2004 had been tested for
viability. (5) at USAMRIID responded that ?work was done to give us evidence
that the viruses were indeed killed by Trizol The CDC continues its investigation to
determine if the shipments of Venezuelan Equine Encephalitis virus violated the requirements of
the Federal Select Agent Program. '49

7. Republic of Korea Shipment of Bacillus anthracis and Yersinla pestls (2014)

In March 2014, shipped a mislabeled package to Republic of Korea containing
inactivated Bacillus anthracis (now known to be viable) from lot along with
attenuated Yersz?nia pestis. '50 The error on the shipping label described the contents as ?4 mL
KILLER ORGANISM ON DRY ICE, UN 8453??1 DPG-LSD sent detailed information to the
DPG Transportation Of?ce, with the nomenclature ?4 mL KILLED ORGANISM ON DRY
The DPG Transportation Office made the typographical error on the shipping
documentation (Transportation Control Number and Commercial

 

'44 Id. 

'45 Select Agents and Toxins, 42 CPR. pt. 73 (18 Mar. 2005).

See Tab 045, Email ??om m, to Carmen Spencer, Douglas Bryce, and (6) Subject: RE:
CDC Issues (15 Sept. 2015).

"7 See Tab 044, Email from to (6) Subject: Inactivated VEE Question (13 Sept.

2010).

Tab C-43, Email from (6) to WSubject: Re: Need help ?nding an inactivation
Confirmation for VEE Trinidad Trizol (1 Mar. 2 13).

"9 See Tab 048, Email from MG Daniel L. Karbler, to LTG Gary 1-1. Cheek Subject: Fw: Regulatory violations
likely (15 Sept. 2015). See also Tab C-49 Spreadsheet with VEE Details (15 Sept. 2015).

See Appendix E, Glossary. A gram-negative bacteria that is the causative agent of plague.

Although this shipment contained material from lot A600001667, this shipment was separate and distinct from
the shipment to Korea that was found after the May 2015 discovery of viable Bacillus amhracis. There has been
widespread public outery and protests by Korean citizens in the aftermath of the May 2015 discovery, so the
shipment of biological materials from the United States remains a sensitive issue for the Korean government:

uardian.com/world/2015/ma /29/ en on-anthrax-australia-ZOOS.

 

29

Invoice) changing to (6)
(6) - id not catch the typographicai error on the shipping documentation when she
labelled the package for shipment.?3

8. Summary

DPG leadership and DPG-LSD management were aware of four of the nine (eight shipping
and one faulty inactivation) mishaps listed above and did not formally investigate or impose
disciplinary actions on responsible individuals.154 The DPG-LSD claims corrective actions were
taken in each case,?55 but due to a lack of attention to detaii, mishaps continued to occur. As
seen in Figure 9, mishaps that required CDC noti?cation were handled appropriately (Events 1, 3
and 6), but the chain of command was not made aware of the non-CDC reportable shipping
errors. '56 Four ofthese events were serious enough that the had the option to
enforce up to $2,000,000 in ?nes against DPG-LSD, but declined to do so since DPG-LSD is a
Government entity. This does not include a potential $500,000 ?ne for the shipments related to
the 22 May 2015 discovery o'fviable Bacillus anthracis at the center of this investigation.

 

Summary of DPG-LSD Historical Mishaps

Reported to or Has Knowled of:
DPG LSD
Event: CDC CDR Director

Lawrence Livermore National This event was reported to the CDC and the Chain of

 

 

 

 

 

 

 

 

 

 

 

 

- Baal/Ills anthrams (2007- Yes Command was fully informed-
Naval Surface Warfare Center -

2 Venezuelan Equine Encephalitis (2010) No 

3 Three Erroneous Shipments of Yes This event was reported to the CDC and the Chain of
Botulinum neurotoxin A (2008-2010) Command was fully informed.

 

Naval Surface Warfare Center 
4 Burkholderia mallei (2010) N0 N0 N0 No Yes Yes

Naval Surface Warfare Center 

 

 

 

 

 

 

 

 

 

 

 

 

5 Vaccinia (2014ECBC and - Venezuelan Yes This event is currently under investigation by the
Equine Encephalitis (2003-2004) CDC.

7 Republic-of Korea - Bacillus amhracis No No NO NO NO Yes
and lerszma pesus (2014)

 

 

 

 

 

Figure 9: Summary Historical Mishaps

 

'52 See Tab C-21, Shipping Documents for Korea incident (2014).

?53 See Tab 028, Memorandum for Record, subject: Teleconference with Dugway Proving Ground Life Sciences
Division (IS Sept. 20l5).

?54 DPG Leadership was aware of at least four of the nine mishaps at the time of their occurrence. Also note that
Event 3 in Figure 9 includes three separate shipments, bringing the total number of events considered to nine.

?55 See Tab page 4,?am?Addendum to DA Form 2823, Swom Statement (21 Aug. 2015).

Reporting for Event 2 ended at the_level, and reporting for Events
4, S, and 7 never made it past the technicians that were involved.

30

Finally, the three additional non-select a ent misha which occurred under the DPG-LSD
cap team consisting Dim

(5) were never reported to the DPG-LSD chain of command. One non-select agent
shipping discrepancy is still under investigation by the CDC. '57 No internal investigations were
conducted and no disciplinary action was taken against any DPG-LSD personnel for any of the
shipping or faulty inactivation mishaps.?8

G. Post 22 May 2015 Events at DPG-LSD

ln reSponse to the 22 May 2015 noti?cation that the private company had received viable
Bacillus anthracis, DPG-LSD began a comprehensive review of the CRP Antigen Repository
shipping records and re-testing of inactivated Bacillus anthracis lots still in inventory to
determine the extent of the inadvertent shipments.159 On 23 May 2015 (Saturday),
noti?ed that the private company was able
to grow Bacillus anthracis Ames from lot AGD0001667 (the lot at the center of this investigation)
and directed her to report to work the following day to begin investigating the issue. On 24 May
2015 (Sunday), pulled [5 random tubes from lot AGD0001667 and plated them onto
soy agar plates, in triplicate, to see if she could repeat the observation found at the private
laboratory. On 25 May 2015, (Monday, Memorial Day), and (6) returned to
the laboratory to read the plates and con?rmed that all 15 aliquots were showing growth/a low
concentration of vegetative bacillus colonies.E60

On 26 May 2015 (Tuesday, ?rst work day after Memorial Day), directed that
every lot of inactivated Bacillus anthracis currently still in storage at DPG-LSD undergo viability
testing. When growth consistent with or characteristic to Bacillus anthracis was observed, the
technicians were instructed to coordinate with the Polymerase Chain Reaction laboratory to
con?rm the Bacillus anthracis growth. The staff at were able to pull and test
Bacillus anthracis from 33 lots produced between 2004 and 2015. Seventeen of the 33 lots tested
positive for Bacillus anthracis growth. Personnel from the Joint Program Executive Of?ce CRP
management of?ce compiled the chart in Figure 10 below which summarizes the test results for
of the 33 lots of Bacillus anthracis that remained in the government?s possession.

 

'57 See Tab C-48, Email from MG Daniel L. Karbler, to LTG Gary H. Cheek Subject: Fw: Regulatory violations
likely (IS Sept. 2015). See also Tab 049 readsheet with VEB Details (15 Sept. 2015).

'58 See Tab B-2. 1 page 4, MAddendum to DA Form 2823, Sworn Statement (21 Aug. 2015).
?59 See Tab B-27.2a, page 6, (6) Addendum to DA Form 2823, Sworn Statement (20 Aug. 20l5).
See 'I?ab 344.231, page 4, (6) Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015).

16! Id.

  
   
  
 

31

 

 

 

 

 

 

 

 

 

 

 

 

Death Dale Lotti Hot? Project Safety Responsible SOP on kGy
Certificate Officer Of?cer Of?cial DTC
01(0105 1/22/04 A600000069 . . 147 Ver 0 
DTCOIOS 1/22/04 AGD0000070 147 0
01mm 8/8/04 A600000515 147 Ver 0
DTC0121 8/8/04 147 Ver 0
DTC0121 8/8/04 A600000516 147 Ver 0
DTC0194 7/28/05 A600000644  147 V9: 0
7/28/05 147 Ver 0
DTC0241 4/17/06 AGD0000774 . 147 Ver 0
DTCOZ42 4/17/06 . 147 Vet 0 .
DTC0251 4/17/06 147 Ver 0 48.78
01(0252 4/17/06 A600000794 147 Ver 0 45.48
DTC0253 4/17/06 147 Ver 0 45.48
DTC0257 4/17/06 AGDOOUU806 14/ Ver 0 45.41
DTCOZSS 4/18/06 147 Ver 0 52.93
01(0268 6/1/06 AGDOUOO830 147Ver 0 43.32
DTC0264 6/1/06 AGD0000822 147 0 45.74
010278 8/23/06 A600000858 147 Ver 0 46.7
DTCD286 8/23/06 147 Ver 0
DTC0310 10/25/06 147 Ver 0
DTC0382 10/2/07 AGD0000950 4959
DTC0383 10/2/07 A600000954 4959
DTC0430 10/18/07 A600000999
DTCO498 8/4/08 A600001039 147 Ver 1
DTC0497 8/5/08 A600001035 147 Ver 1 43.29
DTC0572 5/18/09 151 147 Ver 1
DTC0670 11/4/10 A600001331 5758
DTC0723 10/29/12 43.08
DTC0727 10/29/12 
DTC0803 3/18/14 AGD0001667 119.6
Not Available 14600001575
DTCO791 9/9/14 AI300001631 44.61
Not Available A600001727
DTC0825 1/8/15 A600001675 50.96
Colum lots tested positive in 2015, Nozlhese lots tested negative in 2015
Column (SOP on Death Certificate): Red=Version on the Death Certificate does
not mamh theversion in effect at the time
Colum I (ltGy): Green=Dose was within 40:2 kGy target dose. Redz?Dose was lower than 4012 ltGy
target dose; Yellow: Dose was higher than 4032 kGy target

 

 

 

Figure 10: Test Results

From 26-28 May 2015, CDC personnel were present at DPG-LSD to conduct their own
investigation and to determine if live Bacillus anthracis had been shipped to any other sites. The
CDC determined that the cause of the inadvertent shipment ofviable Bacillus anthracis spores
from lot AGD0001667 was a failure to achieve 100% inactivation ofthe spores
through treatment with gamma radiation. Their review of the inactivation and safety testing
protocol indicated that DPG-LSD was using spore concentrations near the safety limits of the
established dose, and that their safety/viability tests were not suf?cient to detect spores which
were not inactivated by the gamma radiation. The CDC inspectors observed that the DPG-LSD

32

standard operating procedure for the irradiation of Bacillus anthracz?s spore suspensions did not
account for the variable amounts of spores treated in the gamma cell irradiator.162

On 24 July 2015, the CDC sent a letter to the recommending that it assess 
LSD with a civil penalty in accordance with the provisions of section 2623(i) of Title 42 of the
United States Code for violations of the select agent and toxin regulations, Specifically sections
73.12 (Biosafety) and 73.l6 (Transfers) of Title 42 of the Code of Federal Regulations. The
CDC ruled that high concentrations of spore counts resulted in inactivation failures which in turn
led to the transfer of viable Bacillus anthracis to at least 194 domestic registered and non-
registered entities via 575 shipments (as of 2 October 2015). The CDC inspectors observed that
the method used for the inactivation of Bacillus anthracis spore suspensions, Cobalt 60 gamma
irradiation, was not validated using standardized control spore samples at varying concentrations,
volumes, and levels of irradiation. As a result, viable Bacillus anthracis spore suspensions
(spores ligating freely in high purity lab water) were shipped from DPG-LSD as inactivated
samples.

The 156 investigation team visited DPG-LSD ?'om 17-20 August 2015. On 19 August
2015, video footage of the previous 90 days (9 June 2015 ?l 8 August 2015) of work performed
in the DPG-LSD CRP laboratory suite was reviewed by one of the 15-6 investigation team
members. Three incidents were observed. On 27 May 2015, a technician (6) ropped a
rack of sample plates in the CRP Suite. Since the plates were removed from the incubator inside
the biosafety level~3 suite, it is likel that live biological agent was present on the plates. On 14
June 2015, a technician Walled to wear a powered air purifying respirator while
operating and Opening a shaker/ incubator in the CRP Suite. The DPG-LSD standard operating
procedure requires a powered air purifying respirator to be worn whenever an operation might
generate Bacillus anthracis aerosol opening shaker). Finally, on 8 July 2015, (6)
placed laboratory supplies on the front grille of the biosafety cabinet, impeding air?ow both
internally and externally to the primary containment barrier an event that can cause a potential
release of biological agent(s) outside the primary containment barrier. ?64

On 19 August 20l5, in response to actions observed on the video footage and concerns raised
during interviews with DPG-LSD personnel, the 15-6 investigating Of?cer directed (6)

(6) (a member of the 15-6 investigation team) to conduct environmental sam lin in the

CRP laboratories with assistance from the 
As a result of that sampling, on 20 August 2015, live Bacillus anthracis Ames
was continued outside of primary containment in Room 506, a biosafety level-3 laboratory. ?65

  
 
 

 

See Tab 0-1 Memomndum from the Department of Health and Human Services, Centers for Disease and

Control Prevention, to RE: Entity inspection Report: Life Science Test
Facility (LSTF) (05 June .

?63 See Tab 0? Memorandum from the Department of Health and Human Services, Centers for Disease and
Control Prevention, toE_Dcpartment of Health and Human Services subject:
Life Science Test Facility (Registration (24 July 2015).

See Tab B-1.l (b 6 DA Form 2823, Sworn Statement, (24 Au Y. 2015 . See also Tab B-35.2,

(6) DA Form 2823, Sworn Statement (20 Aug. 2015). maibmrvedmx?- work in
the hood as being ?crowded? multiple times in the past.

'65 See Tab B-16.l, M, DA Form 2823, Swom Statement. (24 Aug. 2015).

33

On 20 August 2015, the CDC was noti?ed that live Bacillus anthracis (Ames Strain) was found
outside primary containment, as this is a CDC reportable event. 16"

On 27-28 August 2015, in reSponse to the results ofthe environmental sampling performed
by the 15-6 investigation team on 19-20 August 2015, the CDC sent a team to re-inspect DPG-
LSD focusing on three issues: (1) identi?cation of the source of the contamination outside of
primary containment; (2) identi?cation of any environmental contamination outside of biosafety
level-3 suites; and (3) a determination if personnel who had potentially been exposed had an
opportunity to be seen by occupational medical staff. '67 Based upon the results of this
inspection, the CDC suspended Federal certi?cate of registration to possess, use,
and transfer Bacillus anthracis on 28 August 2015. The suspension was based on 
continued failure to ensure that biosafety and containment procedures were suf?cient to properly
contain Bacillus anthracis. ?68

After further review, on 31 August 2015, the CDC formally suspended 
certi?cate of registration to possess, use, and transfer all select agents and toxins. Accordingly,
DPG-LSD was directed to cease all select agent activities and securely store all select agents to
prevent the?, loss, or release of those select agents and toxins. The CDC stated that the
suSpension of registration was based upon continued failure to ensure that biosafety
and containment procedures were suf?cient to properly contain Bacillus anthracis. The CDC
also identi?ed biosafety lapses that are associated with procedures (such as centrifugation)
common to the manipulation of other select agents, so it decided to expand the suspension of
Bacillus anthracis activities to include all select agents and toxins. '69 On 20 October 2015, the
CDC provided DPG-LSD with an inspection report detailing the various ?ndings of the 27-28
August 2015 inSpection. '70

On 15 September 2015, DPG-LSD had its High-Ef?ciency Particulate Arrestance (HEPA)
?lter system tested in accordance with annual testing and certification requirements. The HEPA
?lter system is designed to be a redundant safeguard to prevent release of biological agents
present in the facility?s air handling system. DPG-LSD contracted with Winergy Services to
perform the test. Winergy published the test results in a written report dated 30 September 2015
which received on l3 October 2015. The HEPA ?lter report indicated that HBPA
Bank Filter (lower right, lower left and upper right) and the lower HEPA Bank A (lower right)

 

166 [d

?57 See Tab Memorandum from the Department of Health and Human Services, Centers for Disease Control
and PreventiOn, to_ Life Science Test Facility, subject: Re-inspection of Life
Science Test Facility (26 Aug. 2015).

See Tab Memorandum from the Department of Health and Human Services, Centers for Disease Control
and Prevention, to _Life Science Test Facility, subject: Suspension of
Registration: Life Science Test Facility (28 Aug. 2015).

'69 See Tab Memorandum from the Department of Health and Human Services, Centers for Disease Control
and Prevention, to (6) Life Science Test Facility, subject: Suspension of
Registration: Life Science Test Facility (31 Aug. 2015).

'70 See Tab Memorandum from the De artment of Health and Human Services, Centers for Disease Control
and Prevention, to_Life Science Test Facility, subject: Entity Inspection Report -
Life Science Test Facility (20 Oct. 2015).

34

failed to pass the annual HEPA certi?cationm (5) stated that the failure may have
originated in the structure of the HEPA ?lter unit, which allowed for leakage around the edges of
the ?lters, not the ?lters themselves.172 Previous HEPA ?lter certi?cations performed by ENV
Services passed all regulatory requirements.173 DPG-LSD contacted ENV Services and
requested that they re-test the HEPA ?lters to verify the results obtained by Winergy. ENV
Services test results matched those of Winergy Services. '74

On 13 October 20l5, received the results of the report and noti?ed the CDC of the
?lter failure. ?75 On 19 October 2015, the CDC requested additional information about the ?lter
failure. On 20 October 2015, DPG-LSD provided the CDC with the requested information.
immediately directed their maintenance personnel to isolate the failed HEPA bank
and to switch over to the HEPA Banks that passed the certi?cation tests. DPG-LSD tagged the
failed HEPA banks and starting coordination to decontaminate the failed banks. DPG-LSD
deveIOped a risk mitigation and environmental sampling plan and noti?ed the CDC on 27
October 2015. At the direction of the CDC, DPG-LSD collected environmental samples from
the post ?lter exhaust tube, plated the collected material, and initiated
decontamination procedures. On 2 November 2015, DPG-LSD submitted a request to the
Executive Agent to have the moratorium and stand-down directive placed on LSD
temporarily suspended so that it could test the environmental samples that were collected.
The request was denied, so the samples were subsequently destroyed in the autoclave. Prior to
destruction a visual inspection of the plates showed no growth for any bacteria. As of l7
November 2015, there is no evidence to indicate that DPG-LSD leadership has attempted to
identify the root cause of the HEPA ?lter failure or investigate the issue beyond what was
requested by the CDC. '77

176

The investi ation team learned about the HEPA ?lter failure during an interview with (6)

(5)

(6) '78 He stated that the DPG-LSD

response to the HEPA ?lter failure was troubling. The personnel at DPG-LSD were not
proactive in their reSponse to the failure and it was only after the CDC requested speci?c
information from DPG-LSD that the CDC saw any evidence of risk assessment and or real action
in response to the failure. (6) stated that he is frustrated with and that this
frustration is due to his impression that ?there does not seem to be anyone at DPG-LSD that is
really thinking about biosafety, how they investigate incidents, what they should be doing to

See Tab C-SO, HEPA Filter Corres ndence and Evidence.
"2 See Tab 8-2.2 for Record, subject: Transcribed Testimony of
M12 Nov. 2015). [Em-states that there was a very small leak around the side of the

filter.
"3 See Tab 050, HEPA Filter Correspondence and Evidence. The HEPA ?lters are inspected/tested annually.

ENV Services conducted the annual ins ections prior to 20 IS.

"4 See Tab 3-2.2 (6) Memorandum for Record, subject: Transcribed Testimony of (5)
(6) (12 Nov. 2015).

See Tab C-SO, HEPA Filter Correspondence and Evidence.

'76 Id. DPG-LSD would not be allowed to test the samples under the terms of the BSAT moratorium.
"7 See Tab 8-2.2 Memorandum for Record, subject: Transcribed Testimony of (6)

 

  
 

35

prevent future incidents, and how they assess the consequences for various incidents??79 He
reiterated that his iarger concern is not with a potential escape, for which there was a low risk,
but rather with the DPG-LSD response, which was insufficient until staff at DSAT started
prodding DPG-LSD for information and action. '30 Also of note, (6) indicated that in
light of historicai issues with incidents not being reported up the chain of command in large
complex organizations like the DOD, the CDC is changing its notification policy to require
parallel noti?cation to senior of?cials in the chain of command (they currently correspond only
with the responsible of?cials at each 

H. Institutional Trends at Life Sciences Division

The DPG-LSD, like other government institutions, has experienced personnel and budgetary
changes over time that affected the organization. The changes over the past 20 years resulted in
a reduction in personnel, a decrease in the level of education and experience of its personnel, and
leadership changes in critical positions. However, since 2007 the leadership at the branch and
division level has remained fairly stable.

1. Personnel Reductions

The Department of the Army has been affected by a reduced budget in recent years. '32
Proportionally, DPG and the likewise experienced budget reductions. As a result, the
civilian work force at DPG-LSD was forced to eliminate positions.?83

In April 2014, DPG-LSD executed a reorganization aimed at mitigating these impacts within
the constraints of authorizations from The end result was a 26% reduction in the
division workforce. '85 In spite of these reductions, DPG-LSD continued to meet the mission
requirements by tasking its personnel to take on additional duties.'86

 

'79 See Tab B-67.l, (6) Memorandum for Record, subject: Summarized Testimony of?

W-(iz Nev. 2015).
1

l8] [at

See generally Michelle Tan, Army lays out plan to cut 40,000 Soldiers, ARMY TIMES, Jul 10, 2015
and Brad
Piumer, America?s Staggering Defense Budget, In Charts, WASHINGTON POST, Jan. 7, 20l3,
13/0 
defense-budget-in-charts.

'83 See Tab B-2.l, page 1-2, (5) DA Form 2823, Sworn Statement Aug. 2015). The most
relevant reduction/reorganization has occurred in the quality assurance/quality control workforce. DPG-LSD lost its
dedicated person in the 201 timeframe and reSponsibility for the overall function has been moved
frOm the division level to the test center level reducing its bandwidth and overall effectiveness.

See Tab l.2.a, page 6, (6) Addendum to DA Form 2823, Sworn Statement (l 0 Sept. 2015).
ISS 
'86 See Tab 1.2, page 2, (5) DA Form 2823, Sworn Statement (IO Sept. 2015).

36

2. Level of Education and Experience

Compounding the impact of the budget and personnel reductions during this period, DPG-
LSD experienced natural attrition of highly educated and experienced personnel due to
retirement and other personal reasons. Furthermore, DPG-LSD often had a dif?cult time
drawing in new highly educated and experienced scientists because of its remote location. This
may have contributed to the erosion of many core capabilities.187

One of the major hindrances to hiring educated scientists at DPG is the fact that it is a
remote installation. The east gate is approximately one hour (45 miles) from Tooele, Utah and
approximately one and a half hours (90 Miles) west of Sait Lake City. The DPG-LSD Life
Science Test Facility is another half-hour (l 7 miles) from the east gate. Most of the DPG-LSD
personnel at the Life Science Test Facility live in ?As work expands, DPG is able to hire
scientists with degrees from further away. As the work wanes, the degreed scientists leave
because they are employable elsewhere.?83 These departures, coupled with budget cuts and the
remote geographical location of DPG-LSD, make maintaining a roster of qualified, 
educated scientists a challenge.

This natural ebb and ?ow of educated scientists creates vacancies because the Army
has dif?culty hiring new accredited scientists to fill positions in an expeditious manner.
As such, has downgraded personnel duty descriptions to hire from within the local
community. This practice allows the stable, local workforce the opportunity to advance and
move into these newly available positions. The Army is also able to continue to meet its mission
requirements, albeit with a less quali?ed workforce. However, the downside of this condition is
that many of the employees in DPG-LSD, occupying positions once held by true Level
microbiologists, do not have graduate level degrees. This practice frustrates the limited number
of highly educated personnel that remain at DPG-LSD. '89 Additionally, this trend creates the
impression that the hiring practices are governed by an inner circle prone to favoritism. '90

To add more credence to this appearance, historically, civilian employees at DPG were not
hired using hiring panels. Many of the current employees still point to old hiring actions as
evidence that an inner circle exists. Hiring panels are now used to decrease the perception of
favoritism and also to reassure the workforce that the hiring process was not biased. 

However, due to the isolated nature of the installation, there are 3rd and 4th generation families
that live near and work at DPG. ?92 The remaining educated scientists have noted that,
even with the new hiring panels, the limited number of highly educated personnel continues to
etuate a less inquisitive workforce more inclined to merely meet mission requirements. (6)
Welaborated on the impact of not having senior scientists with level
educations conducting or supervising operations within the DPG-LSD:

 

l87 

'88 See Tab B-30.l.a, page 5, (6) Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015).
l89 1d

I90 Id

See Tab B-l 1.2, page 2, b) (6) DA Form 2823, Sworn Statement (l0 Sept. 20l5).

'92 See Tab 8-30.] .3, page 5 (6) Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015).

37

Further, the microbiology branch has staffed their senior scientist
positions (for instance the senior only has a high school degree) with
people who do not have the expertise to ask the questions that due diligence
would have required. This situation where nobody was looking for the right
questions, and the information was hidden from anyone who might ask the right
questions, was done purposefully to avoid interference with the need to
accomplish intermediate mission goals. ?93

While this viewpoint cannot be discounted, DPG-LSD contains a core of senior personnel in
supervisory positions that are educated scientists with 20 years of experience in the ?eld
who could provide the leadership and guidance these newer, less educated and experienced
employees need.

3. DPG-LSD Leadership Changes

- irectors over the past l7 years. These two were (6)

each having very different leadership styles. (6) is a
educated scientist who began his career at DPG on 24 March [980 working on applied
microbiology in the aerosol branch. became the DPG-LSD Director in
1998. As the Director, had a hands-on leadership style. He was involved with the staff
in their day-to?day activities in the lab!94 and regularly held morale building eventsl95
le? civilian service in January 2008. After (6) retired, took the DPG-LSD
Director position.

His 3 educated scientist. (6) started working as
a micro l0 ogtst in microbiology branch at DPG-LSD in 199l. (6)

transferred from the microbiology branch to the aerosol branch where he became the section
chief in 2000 and ultimately he became the Director of the DPG-LSD in September 2008.196
(6) is a highly accomplished and respected scientist. However, his leadership style is
more hands off than his predecessor and this has resulted in isolation from the workforce and a
lack of situational awareness.197 freely admits that he has less interaction with his
personnel in the labs than he would like because of the administrative demands placed on him. '98

  

Section II of the ?ndin gs will show that the change in leaders and leadership styles, coupled
with the reduction in personnel, and level of education and experience of its personnel had a
negative impact on DPG-LSD.

 

  
  
  

?93 See Tab page 2, (6) DA Form 2823, Sworn Statement (20 Aug. 2015).

'94 See Tab B?30.l, page 2, DA Form 2823, Sworn Statement (20 Aug. 2015).

See Tab 3-33. 1 page [1-12, (6) Addendum to DA F0rm 2823, Sworn Statement (20 Aug. 20I5).
'96 See Tab page 1-2, 6 DA Form 2823, Sworn Statement (21 Aug. 20l5).

'97 See Tab 3-30. I page 2, m- DA Form 2823, Swern Statement (20 Aug. 2015). See also Tab B-

page 3-4, m? DA Form 2823, Sworn Statement 10 Sept. 2015).
'98 See note I96.

38

I. Background on the Inactivation Process of Bacillus anthracis

9 200

Bacillus anthracis is a gram positive, '9 non-motile, non-hemolytic,201 spore forming202
bacterium that is the causative agent203 of anthrax in humans and animals. Bacillus anthracis is
extensively distributed in the soil throughout the world the United States, Canada, Europe,
and the Middle East).204 Outbreaks of Bacillus anthracis affected both humans and animals
regularly prior to the development of a vaccine in the late 19th Century.205 Periodic outbreaks of
Bacillus anthracis affecting livestock and wildlife are still seen in parts of the United States,
Canada, Europe and Africa.206 While Bacillus anthracis has the capability to cause serious
disease in humans, the disease is non-communicable?? and is treatable either through
vaccination or early administration of antibiotics.208 Since Bacillus anthracis infections are non?
communicable and are often treatable, the organism is classi?ed as a Risk Group 2 organism
(moderagg- individual risk, low community risk) by both the CDC and National Institutes of
Health.

An understanding of the rationale and procedures used to inactivate Bacillus anthracis is
necessary in order to comprehend the potential scienti?c explanations for the inadvertent and
viable shipment of Bacillus anthracis that occurred on 20 April 2015 and was reported on 22
May 2015. The biological industry routinely inactivates biological select agents and toxins to
provide unregistered facilities easy access for the testing and development of vaccines and
equipment used to detect various biological select agents and toxins. Figure 1 1 provides a
simpli?ed look at the life cycle of Bacillus anthracis and Figure 12 depicts the inactivation
process and healing hypothesis for Bacillus anthracis, both of which are described in detail in the
following paragraphs.

 

?99 See Appendix E, Glossary. Gram positive strains of bacteria stain purple with violet dye.

See Appendix E, Glossary. Unable to move.

20' See Appendix E, Glossary. Will not break down red blood cells. Bacterial hemolysis can be identi?ed following
incubation on sheep blood agar. Hemolytic bacteria will have a ring of damaged red blood cells around the colony
forming units.

202 See Appendix E, Glossary. Organisms that have the ability to form spores that facilitate survival in harsh
environmental conditions.

203 See Appendix E, Glossary. An organism that results in disease.

Mullins .IC, Garofolo G, Van Ert M, Fasanelia A, Lukhnova L, Hugh-Jones ME, Blackburn JK., Ecological niche
modeling of Bacillus anthracis on three continents: evidencefor genetic-ecological divergence?. PLOS ONE, 2013,
Volume 8, Epub. See also Smith KL, DeVos V, Bryden H, Price LB, Hugh?Jones ME, Keim P., Bacillus anthracis
diversity in Kruger National Park, JOURNAL OF CLINICAL MICROBIOLOGY, 2000 at pages 3780-4.

305 Pile .l C, Malone JD, Eitzen EM, Friedlander AM, Anthrax as a potential biological warfare agent, ARCHIVES OF
MEDICINE, l993 at pages 429-34.

30" Bacillus anthracis, (last visited 23 Sept. 2015).

207 See Appendix E, Glossary. Not transmissible from person to person.

203 See Pile .IC, Malone JD, Eitzen EM, Friedlander AM, Anthrax as a potential biological warfare agent, ARCHIVES
OF INTERNAL MEDICINE, 1998 at pages 429-34.

209 See Tab E-S, BMBL, section Bacterial Agents; US. Dept. of Health and Human Services, National
Institutes of Health Guidelines for Research Involving Recombinant or Nucleic Acid Molecules,
Appendix B-II-A, (6 Nov. 2013) [hereinafter NIH Guidelines].

39

 

Bacillus anthracis Life Cycle

- Can replicate in environments suitable for bacterial growth
Susceptible to heat, chemical, or other radiological based
inactivation methods

  
  
 

 

Vegetative Cell
Soorulation actors in response to environmental stressors

I ell . . -
Vegem ?3 5 on? spores (Le. Starvation of banana)

In to stress'

brtiger

Dis;

Dormant
Phase

Infectious particle causing the disease anthrax
Can retain antigens of interest tor characterization

- More resistant to neat, chemical. or radiological based
inactivation methous

"Un-germina?tec Spore"

 

 

 

Germination is initiated in response to nutrient availability or
'Gerrninated Spore" other stimuli
- Generallv susceptible to heat, chemical. or moiological based

- Can replicate in environments suitable for bacterial growth
- Susceptible to heat, chemical, or other radiological based
inactivation methods

 

 

 

 

Figure 11: Bacillus anthracis Life Cycle

As seen in Figure l, Bacillus anthracis can exist either as a vegetative cellz?) under normal

environmental conditions or in a dormant spore form211 through either natural or laboratory
induced stressors. The vegetative cell produces a spore containing deoxyribonucleic acids
(DNA) and enzymes used for growth and replication.?2 Antigens or surface proteins are present
on both the spore form and the vegetative cell form and represent critical targets for researchers
attempting to develop diagnostic assays for detection systems.?3 Because assay development
primarily occurs outside of laboratories registered with the CDC Division of Select Agents and
Toxins, it is important for researchers to be able to develop a method that both successfully
inactivates the Spores while preserving the critical antigens used for assay devel0pment.214 The

 

3'0 See Appendix E, Glossary. A vegetative cell is a bacterial cell capable of replication and enzymatic activity. See
Edwards KA, Clancy HA, Baeumner AJ, Bacillus anthracis: toxicology. epidemiology and current rapid?detection
methods, ANALYTICAL BIOANALYTICAL CHEMISTRY, Jan. 2006, at pages 73-84.

2? See Appendix E, Glossary. Dormant spore form is a state of existence where the cell is incapable of replication or
enzymatic activity but is signi?cantly more resistant to harsh environmental conditions. See Friedlander AM,
Anthrax: clinical features. pathogenesis, and potential biological warfare threat. CURRENT CLINICAL TOPICS IN
INFECTIOUS DISEASE, 2000, at pages 335?49; Liu J, Xu J, Chen W, Present status and prospects for the detection of
Bacillus anthracisna reviei-v, WEI SHENG WU XUE BAO, July 2012, at pages 809-15.

2?3 See Setlow P., Germination of Spores of Bacillus Species: What We Know and Do Not Know. JOURNAL OF
BACTERIOLOGY, Apr. 2014, at pages 1297-1305. [hereinafter Setlow P., What We Know].

2'3 See Edwards KA, Clancy HA, Baeumner AJ, Bacillus anthracis: toxicology. epidemiology and current rapid-
detection methods, ANALYTICAL BIOANALYTICAL CHEMISTRY, Jan. 2006, at pages 73?84; Liu J, Xu J, Chen W,
Present status and prospects for the detection of Bacillus anthracis--a review, WEI SHENG WU XUE BAO, July 2012,
at pages 809-15.

2? See Edwards KA, Clancy HA, Baeumner AJ, Bacillus anthracis: toxicology. epidemiology and current rapid-
detection methods, ANALYTICAL BIOANALYTICAL CHEMISTRY, Jan. 2006, at pages 73-84; Liu J, Xu J, Chen W,

40

dormant spore form of Bacillus anthracis is designed to protect it from a variety of
environmental factors including excessive heat or dry conditions and it allows Bacillus anthracis
to exist in this state for years in the absence of germination stimuli?"

Also seen in Figure 1 I, once Bacillus anthracis transitions from the vegetative cell form to
the dormant spore form, a number of physiological changes occur in the organism. Two of the
primary changes are the loss of water weight and enzymatic activity seen in a replicating
vegetative cell. When Bacillus anthracis exists in the spore form, it is comprised of several
layers including an exosporium, an outer spore coat, an outer membrane, a cortex, an inner
membrane, and the Spore core.216 Both the outer and inner membrane help minimize transit of
molecules ?om the spore coat to the spore core.?7 The spore core is comprised primarily of
dipicolinic acid which binds to most of the remaining water within the organism during its
dormant state.218 All of these layers function to protect the spore core from the harsh
environmental conditions that lead to the spore formation.

The spore core contains all of the elements required for growth and replication including
DNA, transfer ribonucleic acids and enzymes that facilitate the transcription and
translation of DNA to protein. While these elements are shared between the spore form and the
vegetative cell form of Bacillus anthracis, the spore core also contains small acid soluble
proteins and a dramatically decreased level of water which may function in gamma radiation
resistance.220 While in the spore form, Bacillus anthracz's exhibits up to a seventy ?ve-fold
greater resistance to gamma radiation compared to the vegetative cell form?? The small acid
soluble molecules have been shown to aid in resistance to chemicals and wet heat inactivation by
forming a protective envelope around the DNA but this function has not been shown to effect
gamma radiation resistance of Bacillus anthracis.222 However, the decreased amount of water
present in the spore core may have an effect on gamma radiation resistance of Bacillus anthracis
since it may minimize both the transit of damaged molecules within the spore core and decrease

 

Present status and prospects for the detection of Bacillus anthracis--a review, WEI SHENG WU XUE BAO, July 2012,
at pages 809-15.

3?5 See Setlow P., Spore Resistance Properties, MICROBIOLOGY SPECTRUM, Oct. 20 Setlow P., What We Know.
3'6 See Setlow P., Spore ResistanCe Properties, MICROBIOLOGY SPECTRUM, Oct. 2014; Setlow P., What We Know.
2'7 See Setlow P., What We Know; Slieman TA and Nicholson WL, Artificial and Solar UV Radiation Induces
Strand Breaks and yclobutane Pyrimidine Dimers in Bacillus Subtilis Spore DNA, APPLIED ENVIRONMENTAL
MICROBIOLOGY, Jan. 2000, at pages 199-205.

2?3 See Setlow P., What We Know.

2'9 See Setlow P., What We Know.

22? See Setlow P., What We Know.

22? See Blatchley Ill ER, Meeusen A, AronSOn Al, and Brewster L., Inactivation of Bacillus Spores by Ultraviolet or
Gamma Radiation, JOURNAL or ENVIRONMENTAL ENGINEERING, 2005, at pages l245-1252; Bowen IE, Manchee
RJ, Watson S, and Tumball PCB, Inactivation of Bacillus anthracis Vegetative Cells and Spores by Gamma
Irradiation, SALISBURY MEDICAL BULLETIN Special Supplement 87, at pages 71-73; Slieman TA and Nicholson
WL, Arti?cial and Solar UV Radiation Induces Strand Breaks and Cyclobutane Pyrimidine Dimers in Bacillus
Subtilis Spore DNA, Applied Environmental Microbiology, January 2000, pages 199-205.

223 See Tab 5-33, Memorandum ??om [Em?to (6) subject: Bacillus anthracis
Questionnaire (28 Aug. 2015); Setlow P., What We Know.

41

the potential formation of hydroxyl radicals.223 Additional reasons for resistance to gamma
radiation remain unclear, but it is likely that some of the properties contributing to ultraviolet
radiation resistance DNA photochemistry, the spore coat, low water content and DNA
repair) affect gamma radiation resistance as well.224

Figure l2 depicts the effects that irradiation has on a Bacillus anthracis spore and the
proposed theory that the spore could undergo a healing phase and revert to a vegetative cell.

 

Bacillus anthracis Inactivation Process
and Healing Hypothesis

- infectious particle causmg the disease anthrax
V'ab'e g'?e?m'mg?i spore - Can retain antigens oi interest for charactenzaiion and assay
development/validation

- More resistant to heat, chemical. or radiological based
inactivation methods compared to vegetative cells

- inactivated agent incapable of reproduction or causing disease
?we? 590'9' - Gamma radiation damages DNA through free radical generation

while largely maintaining antigen Integrity

  

 

  
  

I IRRADIATION

  
 

?5 i 3? Ella}; 
HEALING PHASE 3 3

- After introduction of potential germination (growth
media, freeze/thaw cycle. heat short. etc), damaged spores may
germinate and begin DNA repair process if still viable

  
   

"Damaged Spore"

 

  
 

- Viability testing determines spore survival following inactivation
- Spores confirmed non-viable may be snipped as non-SSH or
VIABIUTY  taken out of ESL-3 for further assay development
- ores determined viable throu testln be reirradiateo?
TESTING 5? ope-L50 inactivation protagols 
hither chararte?zation for
- - Detection Assays

Com Fern-inc Uni! 
detection moan mum testing

 

 

 

Figure 12: The Bacillus anthracis Inactivation Process and Healing Hypothesis

This putative healing phase is important because if the hypothesis is correct, it provides a
potential explanation for why the initial viability test for Bacillus anthracis lot 
(and the other lots addressed in Figure I0) showed no but subsequently did show growth
when tested by the private entity. The putative healing phase has not been thoroughly researched
by the scienti?c community. Potential research gaps associated with the putative healing phase
that can be studied to optimize viability testing protocols include: (I) germination initiation
parameters; (2) gerrninant receptor function post gamma irradiation; and (3) incubation

 

2? See Appendix E, Glossary. A hydroxyl radical is an unstable form of the droxide molecule that can damage
DNA. See Tab [3-33, Memorandum fromto Msubject: Bacillus anthracis
Questionnaire (28 Aug. 2015)

33? See Blatchley Ill ER, Meeuscn A. Aronson AI, and Brewster L.. Inactivation of Bacillus Spores by Ultraviolet or
Gamma Radiation, JOURNAL OF ENVIRONMENTAL ENGINEERING. 2005. at pages I245~l252; Tab E-34.
Memorandum from to . subject: Bacillus anthracis Questionnaire Aug. 20I5):
Mizak L. Mierzejewski Gamma Radiation Resistance of Bacillus anthracis Spores. 
DOSWIADCZALNA I (WARSZAWA). 2003. at pages 315-23; Nicholson WL, Schuerger AC, Setlow
P., The solar (ll-'environment and bacterial spore resistance: considerationsfor Eartlt-to-ii-latzs transport by
natural processes and human space?ight. MUTATION RESEARCH. Apr. 2005. at pages 249?64.

42

conditions temperature, time and growth media).225 Without addressing these gaps,
researchers will continue to have dif?culty balancing the need for definitive testing to validate
the absence of viable agent with the need to deliver the best possible products to their customers.

As seen in Figure 12, at the onset of the Putative Healing Phase following exposure to gamma
radiation, spores can continue to remain within the dormant state and likely do not initiate DNA
repair processes until germination begins. While there is evidence of continued DNA to RNA
transcription and RNA to protein translation processes in the early stages of Spore formation, the
absence of energy and nutrients curtails these processes in the dormant spore state.226 Evidence
suggests variance in temperature, time, salt content, air pressure and nutrients dramatically affect
germination and growth rates 01?Spores.227 The introduction of a potential catalyst could serve to
spur the onset of germination within the Damaged Germinating Spore. The potential catalyst
could be any number of potential factors including but not limited to time, room temperature
incubation, incubation, a freeze thaw cycle, or the introduction of growth media all of
which require ?thher study. Current protocols at DPG-LSD call for the initiation of viability
testing within thirty minutes of Bacillus anthracis exposure to gamma irradiation.228 In this
instance, this rush to viability testing may not be ideal to allow the potential healing (and
subsequent growth) of damaged Bacillus anthracis spores.229

Following the initiation of germination or the transition from the dormant Spore form to the
vegetative cell form, viability testing determines whether gamma radiation of Bacillus anthracis
has achieved the desired outcome of an inactive, non-replicating spore (Figure l2). If gamma
radiation has been successful, the sample is able to be removed from the laboratory for detection
assay or countermeasure development. If however, the sample is determined to still be viable,
replicating Bacillus anthracis is still present and gamma radiation has failed. The method that is
used to determine whether gamma irradiated Bacillus anthracis is still viable is through the
introduction of the sample to growth media. Growth media used to determine the viability of
Bacillus anthracis can be either liquid nutrient broth or solid agar. After being introduced to
growth media, the cell will initiate replication by making an identical copy of the DNA and any
essential cellular materials enzymes, molecules, and cell wall). Once the DNA and essential
cellular materials are copied, the cell begins to divide and separate into two identical cells. The
identical cells then resume the replication process to continue growth. After several cycles of
replication, a colony forming unit becomes visible on the growth medium if Bacillusanthracis is
still viable. On the other hand, and as shown in Figure 12, if the spore DNA and cellular
components are damaged beyond repair capacity, the cell wall will either rupture upon

 

22? See Setlow P., What We Know.

12" See Tab E-33, Memorandum from lb) (6) to (6) subject: Bacillus anthracis
Questionnaire (28 Aug. 2015); Segev E, Smith Y, Ben-Yehuda 8., RNA Dynamics in Aging Bacterial Spores, CELL,
Jan. 20 l2, at pages 139-49.

327 See Chowdhury MS, Rowley DB, Anellis A, Levinson HS, In?uence OfPosrirradiarion Incubation Temperature
0? Recovery OfRadialion-lnjured Closlridium Batu/mum 62A Spores, APPLIED ENVIRONMENTAL MICROBOIDGY,
July I976, at pages I 72-8; Moeller R, Raguse M, Reitz G, Okayasu R, Li Z, Klein S, Setlow P, Nicholson WL.
of Bacillus Sybil/is Spore DNA (0 Lethal Ionizing Radialion Damage Relies Primarily on Spore Core

omponems and DNA Repair. Wit/7 Minor Ejfecls of Oxygen Radical Detoxification, APPLIED ENVIRONMENTAL
MICROBIOLOGY, Jan. 2014, at pages 104-9; Setlow P., What We Know.

22? See Tab 01, 

22" The revised CDC protocols for viability testing (see Tab 8-7) attempt to standardize viability testing timeframcs
to address potential issues of this nature.

43

germination or the spore will not complete the transfer back to a vegetative cell and remain
inactivated. This inactivated spore is the desired outcome of the gamma irradiation inactivation
process since this yields a product that is useful for detection assay development that may be
safely manipulated outside designated laboratories.

J. Rationale and Procedures for Inactivation of Bacillus anthracis

Biological laboratories must be able to inactivate Bacillus anthracis for a variety of reasons,
but the key reason relevant to this investigation is that not all facilities have the biosafety
infrastructure required to work with live Bacillus anthracis. Inactivation allows for Bacillus
anthracis to be worked with at a lower biosafety level, thus increasing the number of facilities
that can work with the organism and enhancing the industry?s capability to develop
countermeasures and detection systems. Manipulation of inactivated Bacillus anthracis does not
require registration with the CDC Division of Select Agents and Toxins and inactivated, non-
viable samples of Bacillus anthracis do not need to be shipped as a biological select agents,230
thus reducing shipping timelines and costs. Furthermore, fewer precautionary measures are
required less personal protective equipment) to manipulate inactivated material in a
laboratory because inactivated samples signi?cantly reduce the potential for laboratory acquired
infection.

infectious samples of Bacillus anthracis are inactivated by Tier I entities a facility
allowed to work with activated Tier I biological select agents and toxins-such as to
facilitate transfer and manipulation of Bacillus anthracis outside of registered laboratories with
virtually no risk to personnel or the public.231 Bacillus anthracis is considered a Tier 1
biological select agent and toxin because it can cause serious or potentially lethal disease through
inhalation, ingestion, or contact with the skin.232 Bacillus anthracis is classi?ed as a Risk Group
2 (a low risk agent associated with human disease that is rarely serious and for which preventive
and therapeutic interventions are often available) organism by the CDC and National Institutes of
Health Guidelines.233 The CDC recommends,234 and the Army requires,235 biosafety level-3
practices and containment for manipulation of production quantities or high concentrations of
cultures of Bacillus anthracis?? This signi?cantly restricts the number of laboratories that may
manipulate Bacillus anthracis while also making it more expensive to train personnel, ship
material and build facilities capable of containing live Bacillus anthracis. in order to maximize
the number of laboratories that may conduct research involving Bacillus anthracis, it is
important that Bacillus anthracis can be inactivated using a process that does not destroy the
potentially valuable components such as antigens or surface proteins useful for diagnostic assays
tests).

 

23? See Overlap Select Agents and Toxins, 42 CPR. pt. 73.4 (12 May 2014)
23' See 42 CPR. pt. 73.4 and 73.1}.

232 [d

233 See Tab BMBL, section Bacterial Agents.

234 [d

235 See DA PAM 385?69, ch. 

23" See Tab E-S, BMBL, section Bacterial Agents.

44

Researchers have many methods available for inactivation of Bacillus anthracis including
chemical, heat/steam and gamma irradiation. Chemical inactivation of Bacillus anthracis can be
accomplished primarily through halogen releasing agents such as a bleach solution or aldehyde
based agents such as formaldehyde?? A problem with the use of halogen releasing agents is
their potential to interact with and disrupt proteins resulting in an inactivated agent that is not
useful for deve10pment of diagnostic tests.? Heat or steam inactivation methods can
successfully inactivate Bacillus anthracis, but similar to chemical inactivation, the end product
will not produce a useful inactivated agent for diagnostic test deve10pment since many proteins
are not stable at high temperatures.239 Gamma irradiation, on the other hand, maintains the
efficacy of chemical and heat/steam methods while also preserving the integrity of the cellular
components required to allow Bacillus anthracis samples to be useful for research and
development.240

Gamma irradiation is a well-documented method for the inactivation of biological agents in
general and Bacillus anthracis specifically.241 Gamma irradiation Of Bacillus anthracis provides
the ability for researchers to test and develop diagnostic assays against antigens of interest with
almost no risk tO personnel after successful inactivation.242 The 13 July 2015 DOD Review
Committee Report documented the different Bacillus anthracis gamma irradiation procedures
employed by DOD laboratories.243 Since there was no standard process mandated by the CDC,
DOD, or the Army, each laboratory used different procedures when performing irradiation.
These procedures are summarized in Figure 13. It can be seen that there are several variables to
consider when irradiating Bacillus anthracis, including but nOt limited to radiation dose, starting
titer (initial concentration), starting volume, and sample temperature.

 

237 McDonnell G, Russell AD., Antiseptics and disinfectants: activity, action, and resistance, CLINICAL
MICROBIOLOGICAL REVIEWS, Jan. 1999, at pages 147?79.

233 {d

339 See Britt KA, Galvin J, Gammell P, Nti?Gyabaah J, Boras G, D, Ramirez JG, Presente E, Naugle G,
Endotoxin inactivation via steam?heat treatment in dilute simethicone emulsions used in biopharmaceutical
processes, BIOTECHNOLOGY PROGRESS, Sept?Oct. 2014, at pages 1 145-60; McDonnell G, Russell AD., Antiseptics
and disinfectants: activity, action, and resistance, CLINICAL MICROBIOLOGICAL REVIEWS, Jan. 1999, at pages 147?
79.

24? See Dauphin LA, Newton BR, Rasmussen MV, Meyer RF, Bowen MD, Gamma irradiation can be used to
inactivate Bacillus anthracis spores without compromising the sensitivity of diagnostic assays, APPLIED
ENVIRONMENTAL MICROBIOLOGY, at pages 4427-4433.

See Horne, Turner and Willis, inactivation of Bacillus anthracis by G-radiation, NATURE, 1959, at pages 475-
476.

242 See Dauphin LA, Newton BR, Rasmussen MV, Meyer RF, Bowen MD, Gamma irradiation can be used to
inactivate Bacillus anthracis spores without compromising the sensitivity ofdiagnosiic assays, APPLIED
ENVIRONMENTAL MICROBIOLOGY, at pages 4427-4433.

343 See Tab page 35, Review Committee Report: Inadvertent Shipment of Live Bacillus anthracis spores by
DOD (July 13, 2015).

45

 

 

 

 

 

 

Irradiation
alinrnlory . . . . . Starting
 Dose Determination Shining In? Irradintor \?oltunc ontrol
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and calibration data from I0s clirml de?ned irradialor
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(Surround)
4 3 .
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:1 6 9x10 wnli Jl. Shepard Fwd" i? 
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'bi
. . .ll. Shepard and .
Dugwuy 3842 .\l.mme dosimeter rest w" Assoc. 484R.) 20_30 .-. Nustatedm 
protocol
I (Turntable)

 

 

 

 

(at Speci?ed in 6. 'l 5 meeting at ECBC

Specifiedin 6-9 l5 meeting at 
Specitiediu 6-1715 meeting at DPG

lut'wmalion prmided alter site \?isil

Figure 13: Gamma Irradiation Doses for Inactivation of Bacillus anthracis by 
Laboratories

One of the missions of the Critical Reagents Program Antigen Repository at DPG-LSD was
to provide inactivated Bacillus anthracis that could still be used in the development of diagnostic
tests required by the Chemical and Biological Defense Program (see Section It was
imperative that the program identify an irradiation dose high enough that it would effectively kill
all Bacillus anthracis spores in a sample while not destroying the potentially valuable
components such as antigens or surface proteins useful for diagnostic assays tests).244

In order to standardize and control the process for inactivation of Bacillus anthracis, it is
important to develop standard operating procedures and protocols that ensure repeatability
independent of the personnel who are performing the procedure. Standard operating procedures
require initial development by trained personnel coupled with an extensive review by subject
matter experts to ensure that the procedure is suitable for the task to be performed.245 Following
the development and review process, the standard operating procedure can then be implemented
once designated personnel are trained on the task outlined in the standard operating procedure.246
This ensures that all personnel performing the selected task have the ability to perform the task in
a fashion that is repeatable across the facility with minimal variation.

Prior to 22 May 2015, DPG-LSD had one properly vetted standard operating procedure?7
to address the inactivation of Bacillus anthracis. All standard operating

 

2? See Tab page 2, i b) (6) DA Form 2823, Sworn Statement (18 Aug. 2015).

345 See AR 385-10, ch. 9-l; DA PAM 385-69, ch 3-5.

Id.

3" See The DPG-LSD RP team was also using a work instruction to inactivate CRP materials. the complete vetting
of which is questionable.

46

procedures performed by DPG-LSD are labeled according to their function. WDL references the
West Desert Laboratory while any standard operating procedure featuring a BIO heading
references biological agents. Since 2001, the inactivation standard operating procedure, WDL-
BIO-147 changed eight times. From December 200i thru March 201 1, Versions 0-3 of Standard
Operating Procedure did not specify a radiation dose required to inactivate any
biological agents in general and Bacillus anthracis speci?cally. From March 201 1 thru the
present Versions 4 to 8 of this standard operating procedure speci?ed a target dose of 40 i 2 kilo
Gray for Bacillus species; however, Standard Operating Procedure WDL-BIO-147 also
stated that failure to demonstrate sterility/kill during viability testing should be followed by
additional round(s) of irradiation with no speci?cation on the upper acceptable limit the
upper limit would likely exceed the target dose of 40 d: 2 

K. Procedures for Viability Testing of Bacillus anthracis

Post?irradiation viability testing is necessary to ensure that the inactivation procedure killed
all Bacillus anthracis present in the sample.250 Prior to the discovery of viable Bacillus
anthracis on 22 May 2015, there was no consensus viability testing standard mandated by the
CDC. When conducting viability testing, every opportunity should be provided for the
inactivated specimen to grow. Because of the range of types of samples that require inactivation,
there is extensive variability amongst entities both within and outside the government on what
constitutes appropriate viability testing procedures?? There is extensive variability among
facilities with respect to time lag between inactivation and the initiation of viability testing,
incubation periods, types of growth media, and the amount of the sample to be used for viability
testing. Incubation periods may range from as little as 48 hours to three weeks. Growth media
may be comprised of either solid agar252 or liquid broth in varying amounts and types. Viability
testing sample sizes vary from as little as 5% to as much as 50% of the irradiated material.
Figure 14 summarizes the different protocols for viability testing of inactivated Bacillus
anthracis samples across the four primary laboratories??

 

243 See Appendix E, Glossary. Gray refers to absorbed dose of radiation in units of Joules per kilogram.

249 See generally Tab C-l 

25? Sample refers to an agent that is inactivated. The agent may be present as spores ?oating in liquid or other
specimen tissues, plasma, blood).

25? See Tab D-2, page 36, Review Committee Report: Inadvertent Shipment of Live Bacillus anthracls spores by
(July 13, 2015).

252 See Appendix E, Glossary. Type of media present in petri dishes used for growing biological agents.

353 See Tab D-2, page 36, Review Committee Report: Inadvertent Shipment of Live Bacillus anthracis spores by
BOB (July 13, 2015). For example, current DPG-LSD protocol calls for a 5% sample of the irradiated material to be
inoculated into 2X nutrient broth (the concentration of nutrients are twice as high compared to standard growth
media) and incubated at for 48 hours. Two hundred microiiters of inoculated broth is then plated across 10
Soy Agar plates and the plates are incubated for a minimum of 48 hours and in some cases as long as two
weeks to determine growth.

47

 

 

 

 

 

 

 

 

 

i Sterility 'l esnng
Sampling i Culture A-ledia Incubation
_a oratorv . 
I I it? me Solid ?ed? Broth to Direct Incubation incubation PCsilch Negative
1 ?Int: 1? Plate-1? I Plating Temp Time (hrs) control? control?.?
25-3? 
10% None 51m" No 1.00 "appropriate I No No
Agar til-plate .. 
I growth temp I
I .
. - a. None Blood Agar None None . . LSAMMID I idenuhcd . I Identi?ed 4 \m e? 

1 Blood Agar,  
Brain Heart Bram Bean I Broth:
. Small \01. . . Infusion I 
MU I lulusion Lame 'Vor Brodi 1 Jooplare . 34-3? ?2 Yes ?59; .
3.0 +10% plated Plates: 1
Serum Aga'r? 72 
1 Mueller? . 
Hinton agar 
Dugway 3% nutrient 10.13230} ?nialSpeci?ed in 6.8- 15 meeting at ECBC
Specified in 6:915 meeting at 
Speci?ed in 6. 17 15 meeting at DPG

Figure 14?: Variability in Viability Testing Protocols across DOD Laboratories

The events surrounding the inadvertent shipment of live Bacillus anthracis discovered on 22
May 2015 resulted in a change in policy from the CDC. Due to the fact that numerous separate
entities within and outside the U.S. Army inactivate Bacillus anthracis utilizing a variety of
methods and conduct viability testing with extensive variation in growth media and incubation
temperatures often without consultation outside of their own laboratories,254 the CDC published
revised, interim viability testing protocols for inactivated Bacillus anthracis. The revised CDC
procedure requires the use of both solid and liquid growth media and a 14 day incubation period
at both room temperature and 

In summary, there have been years of research Spent on the inactivation of Bacillus anthracis.
The methods used to inactivate and test viability have morphed over time but scientists still lack
a total understanding of how spore concentrations, strain differences in gamma radiation
resistance, different gamma irradiation dosages, possible post gamma radiation healing of
irradiated Bacillus anthracis spores incubation time and potential and growth
processes affect overall viability. However, the bene?ts and rationale for inactivation are clear:
(1) case of use and transportation, (2) safety of researchers and the public, and (3) the fact that
inactivated spores offer every bit as good of a mission product as viable Bacillus anthracis.

 

25? See Tab D-2, pages 1 1-12, 14 and 16, Review Committee Report: Inadvertent Shipment of Live Bacillus
anthracis spores by DOD (July 13, 2015).

355 See Tab E-T, Centers for Disease and Control Prevention, Revised Viability Testing Protocol for Samples of
Inactivated Bacillus anthracis (2015).

43

L. Background Discussion on Death Certi?cates

The US. Department of Health and Human Services and the US. Department of Agriculture
have established regulatory requirements for the possession, use, and transfer of biological
agents and toxins that have the potential to pose a severe threat to public health and safety,
animal and plant health, and animal and plant products. The requirements related to public
health and safety can be found at 42 Code of Federal Regulation Part 73 and are referred to as
the select agent regulations. The select agent regulations state that non-viable select agents are to
be excluded from these regulations. For the purpose of the regulations, ?non-viable? and ?non-
functional? are similar terms that may be de?ned as the loss of biological activity. For a select
agent, the term ?non-viable? means that a select agent is no longer capable of growing,
replicating, infecting, or causing disease.256 As discussed in the paragraphs above, there are a
variety of inactivation methods available to render a select agent non-viable, and viability testing
is conducted to con?rm that the inactivation process was successful. Subsequently, it is prudent
to document the ?death? of an organism that has gone through an inactivation process and
con?rmatory viability testing.

The DPG-LSD initially elected to use the Certi?cate of Inactivation, which was subsequently
renamed the death certi?cate, as its means of demonstrating that a select agent has been rendered
non~viable. The death certi?cate documents the following data: name of organism; place and
date of sterilization; procedure used for sterilization; total dosage of irradiation applied; a brief
description of the procedure used; reference article, standard Operating procedure, etc.);
notebook page and location of results; and place of con?rmation. The death certi?cate is signed
by three individuals: (I) Project Manager or Principle Investigator; (2) Biological Safety Of?cer;
and (3) Responsible Of?cial (all of whom certify the accuracy of the data and that the organism
was inactivated). A death certi?cate is sent with each sample of Bacillus anthracis that is
shipped to another organization.?7

II. Findings

The inadvertent shipment of viable Bacillus anthracis is a serious breach of regulations, but
it did not pose a risk to public health. Over the years, checks and balances and signi?cant
safeguards were in place and effectively ensured the various mishaps described above were not a
threat. Below is a discussion of ?ndings the 15-6 investigation team made during the course of
the investigation.

The 15-6 investigation team conducted extensive interviews and research to identify a
speci?c cause or group of causes and to eliminate potential contributing factors. Insuf?cient
evidence was found to link the incident reported on 22 May 20l5 directly to one of these
potential causes. The evidence did not allow for the elimination of any potential contributing
factors, and in fact uncovered additional failures. Although the facts do not support a speci?c
?nding of what speci?cally caused the viable shipment, a number of scienti?c, institutional, and
individual conditions/actions exist that contributed to an environment that permitted the
shipment of Bacillus anthracis lot and the sixteen additional lots that have since

 

25" See Exemptions for HHS Select A ents and Toxins, 42 CPR. pt. 73.6.
25? See Tab 3-44. I pages 543% Addendum to DA Form 2823, Sworn Statement 8 Aug. 2015).

49

been identi?ed as viable from 2004-2015. A preponderance ofthe evidence does not exist to
support a ?nding that a group ofindividuals or institutions, or a speci?c individual or institution
was the proximate cause for the unacknowledged and unintended shipment of viable Bacillus
anthracis. The investigation process led to the conclusion that no one condition or action is the
sole cause; rather, it is a combination of all conditions and actions that may have contributed to
the viable shipment.

A. Scienti?c

Over the course of the investigation, a number of scienti?c and technical issues related to the
production, inactivation and post?inactivation viability testing of Bacillus anthracis were
identi?ed. A knowledge gap exists in the state of the scienti?c research informing the current
irradiation and viability testing protocols. This knowledge gap makes attributing accountability
for shipment of viable Bacillus anthracis impossible since personnel have in most cases been
adhering to established and accepted protocols now known to be inadequate. The following
paragraphs provide detail on: (1) the fundamental disconnect between science and regulatory
policy regarding 100% inactivation killing) of Bacillus anthracis before shipping to various
laboratories; (2) lack of research into gamma radiation resistance properties and inactivation
methods of Bacillus anthracis (strains, spore counts, kill curves); (3) lack of research regarding
post-irradiation spore recovery theory; and (4) lack of scienti?cally validated and standardized
protocols for post-irradiation viability testing (incubation time, type of growth media). I

l. A Fundamental Disconnect between Science and Regulatory Policy Regarding Non-
viability 100% Inactivation) of Bacillus anthracis Before Shipping to Various
Laboratories

Current standards require that any entity possessing biological select agent and toxin strains
ofBacillus anthracis must register with the CDC Division of Select Agents and Toxins based on
the fact that it is considered an overlap select agent.258 ?Non-viable overlap select agents or
nonfunctional overlap toxins? are excluded from being regulated.259 The requirement for
registration is independent of the amount of viable Bacillus anthracis even if the amount is as
low as one colony forming unit. Therefore, the only way to guarantee a sample is non-viable or
nonfunctional 100% inactivation) would be to test and consume i00% ofthe batch or
sample. This is obviously not feasible as there would be no usable product remaining. Current
viability testing procedures for the primary laboratories dealing with Bacillus anthracis
generally utilize a 5-10% representative sample from the inactivated lot of Bacillus anthracis.
This means that 90-95% of the lot remains for end use after testing, but also implies that there
will always remain a possibility that the portion of the lot that was not tested may not have been

260

 

253 See Registration and Related Security Assessments, 42 C.F.R. pt. 73.7; and Overlap Select Agents and Toxins,
42 CPR. pt. 73.4.

259 42 CPR. pt. 73.4 defines overlap agents as having the potential to pose a severe threat to public health and
safety, to animal health, or to animal products. Additionally, 42 CPR. pt. 73.4 does not de?ne ?non-viable viable
overlap select agents or nonfunctioual overlap toxins.? Neither the CDC nor the US. Army has issued any guidance
in the form of regulation, policy, guideline, or standard operating procedures.

26? See Tab D-2, page 36, Review Committee Report: Inadvertent Shipment of Live Bacillus anthracis spores by
BOB (July 13, 2015).

50

completely inactivated. It is important that regulators and entities registered to work with
biological select agents and toxins come to an understanding to resolve the separate messages
concerning viability testing.

It is clear that when conducting viability testing it is important to sample a large enough
volume to maximize the likelihood of detecting any viable Bacillus anthracis spores while at the
same time leaving enough sample to be used for other purposes. The ECBC, USAMRIID and
NMRC all used different sample sizes when conducting viability testing?? Based on these
differences, the CDC released interim guidance that requires that 10% of the sample be used for
viability testing. 262 No registered entity working with Bacillus anthracis will be able to
guarantee 100% inactivation unless all of the sample is consumed by viability testing. There will
always be a measure of uncertainty involved with inactivation of biological select agents and
toxins.

2. Lack of Research into Gamma Radiation Resistance Properties and Inactivation
Methods of Bacillus (strains, spore counts, kill curves)

There is a lack of scienti?c research regarding the inactivation methods developed for
Bacillus anthracis. While there are a number of Army laboratories that inactivate Bacillus
anthracis through gamma irradiation, they rely on limited datasets derived ?om a small number
of facilities?? Army facilities generating kill curves against Bacillus anthracis did not take into
account different matrices such as whole blood, tissue Specimens or standard buffer. Kill curves
generated against Bacillus anthracis also do not take into account variations in stock purity or
stock concentrations which can be as high as Spores/ml.264 In some cases, the expected
ef?cacy of the gamma irradiation dose against Bacillus anthracis is extrapolated in the absence
of data from tests using varying concentrations of Bacillus anthracis spores.265

There is also evidence that there is variability in gamma radiation resistance properties
among the multiple strains of Bacillus anthracis that exist, but limited data on these strain
speci?c resistance properties has been collected.266 While signi?cant variation is seen between
vegetative cells and spores related to gamma irradiation resistance, one experiment demonstrated
only slight differences are seen between Bacillus anthracis Ames and Sterne strains.267 In one
experiment, 41.5 kGy was suf?cient to inactivate almost all lots of Bacillus anthracis spores, but

 

261 Id

262 See Tab E-7, Centers for Disease and Control Prevention, Revised Viability Testing Protocol fOr Samples of
Inactivated Bacillus anthracis (2015).

See Tab 0-2, pages I4 and 16, Review Committee Report: Inadvertent Shipment of Live Bacillus
anthracis spores by DOD (July 13, 2015).

3? Id. at page 35.

265 See Tab pages 6-7, DA Form 2823, Sworn Statement (20 Aug. 2015); Tab D-2, page 20,
Review Committee RepOrt: Inadvertent Shipment of Live Bacillus anthracis spores by 000 (July 13, 2015).

16" See Bowen E, Manchee RJ, Watson S, and Tumball PCB, Inactivation of Bacillus anthracis Vegetative Cells
and Spores by Gamma Irradiation, SALISBURY MEDICAL BULLETIN, Special Supplement 87.

257 See Bowen J13, Manchee RJ, Watson S, and Tumball PCB, Inactivation of Bacillus anthracis Vegetative Cells
and Spores by Gamma Irradiation, SALISBURY MEDICAL BULLETIN, Special Supplement 87; Spotts Whitney EA.,
Beatty ME., Taylor TH. Jr., Weyant R., Sobel J., Arduino ML, Ashford DA., Inactivation of Bacillus anthracis
Spares. EMERGING INFECTIOUS DISEASES. June 2003, at pages 623-7.

5 

failures following viability testing were seen in a small number of lots receiving doses up to 44
kGy.268 it is important to determine if strain variance of gamma irradiation resistance is a
signi?cant variable with Bacillus anthracis spores. Evidence in the research literature is
inconsistent and demonstrates both the need for further study and the need to avoid reliance on
kill curves from a single irradiator on one strain of Bacillus anthracis spores to serve as the basis
for all irradiator dosage determinations for all Bacillus anthracis strains. By simply relying on
one target dose of gamma irradiation for inactivation of Bacillus anthracis spores, researchers
open themselves up to potential inactivation failures due to strain variation in the absence of
further methodology development prior to inactivation. Additional study is needed to close these
gaps in validated studies related to gamma irradiation inactivation of Bacillus anthracis.

3. Lack of Research Regarding Post-Irradiation Spore Recovery Theory

Prior to the reported discovery of viable Bacillus anthracis of 22 May 2015, minimal research
had been conducted into the theory of spore recovery following exposure to gamma irradiation.
The 22 May 2015 discovery highlighted the gap in scienti?c understanding, and resurrected the
need to better understand the theory of spore recovery. Previous research conducted supports the
theory that Bacillus anthracis spores may have the ability to undergo DNA repair following
inSult damage due to gamma irradiation), but the extent of these repair processes have not
been determined.269 In addition to the unknowns about the extent of DNA repair, the timeline
for initiation of DNA repair processes is also not well understood with reSpect to spore
germination timeframes.270 Spores may survive gamma irradiation exposure through the
germination process to revert back to a vegetative cell state and resume replication. However, it
is unknown how much DNA damage can be sustained by Bacillus anthracis spores before they
are unable to germinate and revert back to the vegetative cell state. Researchers have repeatedly
demonstrated that Bacillus anthracis Spores are signi?cantly more resistant to gamma irradiation
than vegetative cells but the reasons for this increased resistance remain unclear?" While DNA
repair processes in Bacillus anthracis have been demonstrated following sublethal exposures to
gamma irradiation, Bacillus anthracis Spore recovery has not been shown following large scale
damage from a lethal dose of gamma irradiation.272 Prior to the discovery on 22 May 2015,

 

26? See Bowen JE, Manchee RJ, Watson S, and Turnball PCB, Inactivation of Bacillus anthracis Vegetative Cells
and Spores by Gamma Irradiation, SALISBURY MEDICAL BULLETIN, Special Supplement 87.

369 See Tab E-33, Memorandum from m? to M, subject: Bacillus anthracis
Questionnaire (28 Aug. 2015); Yang H, Yung M, Li L, Hoch 1A, Ryan CM, Kar UK, Souda P, Whitelegge JP,
Miller .lH, Evidence that is a Novel 5 Double-stranded DNA Exonuclease Acting in Bacillus anthracis
Mismatch Repair, DNA REPAIR 1 May 2013, at pages 334-46; Yang H., Yung M, Sikavi C., Miller JH.,
The Role of Bacillus anthracis RecD2 Helicase in DNA Mismatch Repair, DNA REPAIR (AMST), Nov. 201 I, at
pages 1121?30; Setlow P., What We Know.

27? See Setlow P., What We Know.

27' See Mizak L, Mierzejewski J. Gamma Radiation Resistance of Bacillus anthracis Spores. 
Doswiadczalnal Mikrobiologia (Warszawa), 2003, pages 315-23; Setlow P., What We Know; Slieman TA,
Nicholson WL., Artificial and solar UV radiation induces strand breaks and cyclobutane pyrimidine dimers in
Bacillus subtilis spore DNA, APPLIED ENVIRONMENTAL MICROBIOLOGY. Jan. 2000, at pages 199-205.

172 See Memorandum from (6) to ubject: Bacillus anthracis Questionnaire (28 Aug.
2015); Memorandum from [Em?to subject: Bacillus anthracis Questionnaire (8 Sept.
2015); Yang H., Yung M., Li L., Hoch JA., Ryan CM., Kat UK., Souda P., Whitelegge Miller JH., Evidence
that is a Novel 5 Double-stranded DNA Exonuclease Acting in Bacillus anthracis Mismatch Repair, DNA

52

Bacillus anthracis spore recovery was shown to be possible after exposure to sub-lethal levels of
gamma irradiation but survival following exposure to lethal levels of gamma irradiation were
thought to be dependent on innate resistance properties of Bacillus anthracis spores that are not
well understood.273 It is clear that there are unresolved questions related to Bacillus anthracis
DNA repair following gamma irradiation, the extent of the Bacillus anthracis DNA repair
process, the timeframe of the DNA repair process in relation to spore germination, and how
much DNA damage can be sustained by Bacillus anthracis spores before they are unable to
revert back to the vegetative cell state. It is also clear that there is a lack of data pertaining to
optimal germination conditions for Bacillus anthracis Spores and any intermediate processes 
freeze/thaw, heating, and elevated pressure) that may be required prior to incubation on growth
media. If these conditions are abie to be determined and validated, researchers will be able to
have increased con?dence in viability testing if no growth is discovered on irradiated samples
following ideal germination conditions.

4. Lack of Scienti?cally Validated and Standardized Protocols for post-Irradiation
Viability Testing (Incubation Time and Type of Growth Media)

There is a lack of knowledge regarding optimal growth and germination conditions following
gamma irradiation of Bacillus anthracis that may affect the putative spore recovery process.
Standard conditions for growth of Bacillus anthracis may rely on removal of a representative
sample (5-1 and incubation on growth media274 for a minimum of 48 hours. However, given
the demonstrated wide range of both germination and growth rates of spore forming bacteria and
the varying temperatures and growth conditions, further study of optimal growth conditions for
Bacillus anthracis is necessary.275

B. Institutional

A number of institutional factors may have contributed to the inadvertent shipment of viable
Bacillus anthracis. The investigation identi?ed the following institutional concerns that spanned
chain of command: (1) perception of competition for funding between biological
research commands; (2) lack of unity of command; and (3) inadequate inspections.

1. Perception of Competition for Funding Between US. Army Biological Research
Organizations

In the Background Section l.B.2. of this report, laboratory funding sources were discussed as
being a mix of reimbursable (customer funded) and non-reimbursable (Army centrally funded).

 

REPAIR (AMST), May 2013, at pages 334-46; Yang H., Yung M., Sikavi C., Miller The Role ofBacillus
anthracis RecD2 Helicase in DNA Mismatch Repair, DNA REPAIR (AMST), Nov. 20l l, at pages] l21-30.

   
   

2" See Memorandum from (6) to (6) subject: Bacillus anthracis Questionnaire (28 Aug.
20l5); Memorandum from 6 to (6) subject: Bacillus anthracis Questionnaire (8 Sept.
20l5); Memorandum from (6) to (6) subject: Bacillus anthracis Questionnaire (28
Aug. 2015).

37? See Tab 0-2, page 36, Review Committee Report, Inadvertent Shipment of Live Bacillus anthracis spores by
DOD (July 13, 20l 5).

275 See Cook AM, Roberts TA, Widdow50n JP., Gamma Irradiation of Bacillus Subiilis Spore In the Presence of
Sugars. JOURNALOF GENERAL MICROBIOLOGY, Feb. 1964, at pages 185-193.

53

Some within the US. Army Biological Research Organizations maintain a perception that this

fundini scheme ieads to counteiroduetive comietition between the laboratories. According to

As an Enterprise, the Chemical and Biological Defense Program organizations
are very competitive. Although we have relatively de?ned lanes, we are all
competing for the same funding. Asa result, communication and collaboration
between organizations like WDTC, USA MRIID, and ECBC is minimal. We do not
share best practices and conduct peer reviews unless we are directed to do so.

The prevailing mindset is that we don ?t want to give up business to each other,
and anything that appears to ?give away the store to a competitor is avoided. 276

Evidence compiled by the 15-6 investigation team does not support (6) . claim of
actual competition. This evidence includes a direct comparison between the laboratories and the
reimbursable funding each receives. While the laboratories share customers, their work is
mostly complementary in that they support the customers in different ways and in different
phases of their projects. Appendix provides a detailed breakdown of the USAMRIID, ECBC,
and DPG-LSD funding profiles (reimbursable and non-reimbursable).

While the perception of competition was unfounded, DPG and DPG-LSD experienced
budget reductions over the last several years. In reSponse to the budget reductions, DPG-LSD
eliminated several positions and attempted to continue to meet mission requirements by tasking
personnel to take on additional duties. At least one of the eliminated positions was critical to the
effectiveness of the production mission of the Antigen Repository.277 An executive agent
and overall unity of command directing the allocation of resources may have mitigated the
impact of funding cuts and allowed DPG-LSD to retain personnel in critical positions.

2. Unity of Command

After a review of the number of commands and reporting channels within the DOD biological
laboratory enterprise, the 15-6 investigation team has determined the US. Army command
structure alignment lacks an overall Executive Agent to provide oversight for the separate
reporting commands. An Executive Agent empowered to oversee the laboratory enterprise and
address standardization of rules, practices, and procedures could potentiain overcome this
misalignment.

Figure l5 depicts the various chains of command for each of the laboratories and shows
that command and control of the biological laboratories is diSpersed. Each laboratory has a
different mission and ?rst-line command. ECBC reports to the Research Development and
Engineering Command, reports to the U.S. Army Medical Research and Materiel
Command, and Dugway Proving Ground reports to ATEC. There is no convergence at a higher

 

37" Tab 3-2.1, page 2, (6) DA Form 2823, Sworn Statement (21 Aug. 2015).
377 See Section ll.C.l.b.iv. One of these positions was for a dedicated quality assurance/quality control manager? a
critical position providing oversight for production within the laboratories.

54

level of command.?8 Figure 16 depicts placement ofthe laboratories in the overall Army

Command structure. The higher level commands for USAMRIID and DPG are the Army
Medical Command and ATEC respectively. Figure 16 shows that ATEC and Army Medical
Command are Direct Reporting Units to Headquarters Department of the Army. The ECBC
ultimately reports to the Army Materiel Command, a distinct Army Command. While these
commands may have some commonality at the working level, their over?arching missions are
separate and distinct.

 

Chief of Staff Chief of Naval

Army Operations

   

  
 

Director Army

I Staff

  

 

 

 

   

 

 

 

 

 

 

 

 

 

 

 

a
. . Nav Bureau of
Army Materiel Army Medical y. .
Medicine and
Command Command 
I I 
Research 
Development and Medical Research and Army Test and
Engineering Hateriet Command Evaluation Command
(Eminent! I 

Edgewood Chemical Rysisg?ngg?iglof nugway Proving Navy Medical
Biological Center Infectious Diseases Ground Research Center
(DPG) 


 

 

 

 

 

 

Figure 15: Chains of Command for Biological Labs

 

373 Figure 15 represents the current command structure. Until 201 I there was an additioual One star command
between DPG and ATEC known as the Developmental Test Command (DTC). This command was absorbed into
ATEC headquarters as part of base realignment and closure in 20] 1. Additional discussion regarding this
realignment and its impact on operations at DPG is provided in Section 

55

 

 

  
 
   
 

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ARCENT
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Figure 16: Army Command Structure
3. Failure to Inspect the Technical Aspect of Bacillus anthracis Inactivation

The ?nal institutional area concerns the frequency and completeness of inspections. This
includes the scope, frequency, and method of accomplishment (announced versus unannounced).
Historically, major inspections have been announced, allowing the laboratories to extensively
prepare. During inspection timeframes, laboratories typically do not perform select agent
operations, so only written procedures and laboratory structural and cleanliness issues are
normally observed. The inspections focus on policies and procedures as opposed to production
protocols. In addition, conducting inspections every two or three years may not be frequent
enough to ensure biological laboratories operate safely and ef?ciently.

Army laboratories are subjected to three main categories of external inspections; a) Federal
Inspections, b) Army Biosurety Inspections, and c) Army Safety Inspections. Additionally, the
15-6 investigation team reviewed the ?ndings of a technical audit perforated by a commercial
company at DPG-LSD in 2004 (paragraph Background information regarding the scope and
purpose ofthe inspections as well as a summary ofthe ?ndings ofthe 2004 audit is provided in
the following paragraphs.

a. Federal Inspections

Federal inspections are conducted by the CDC and the Animal and Plant Health Inspection
Service, Department of Agriculture, at Army laboratories that possess and use select agents.
These two agencies are authorized in the Code of Federal Regulations to administer the Federal
Select Agent Program. Organizations that possess or use select agents are required by law to
register with the Federal Select Agent Program. Registrations must be renewed every three
years. Before the renewal, the CDC and the Animal and Plant Health Inspection Service perform
ajoint inspection to ensure all the requirements in the various regulations are being followed.

56

These inspections are announced allowing the organizations to prepare for them. The CDC and
the Animal and Plant Health inspection Service may perform additional inspections on an as-
needed basis to register a new room for select agent work, to look at past problem areas, or
to investigate a potential violation of the Federal Select Agent Program). These inspections may
or may not be announced.279

b. Army Biosurety Inspections

Biosurety inspections are conducted by the Department of the Army Inspector General
(DAIG) as mandated by Army Regulation 50%, Biological Surety. Inspections normally occur
every 24 months and are compliance-based vice science?based. These inspections ensure
adherence to the technical, health, safety, accountability, security, and reliability standards
detailed in appropriate regulations.230 Since 2005, DPG-LSD has passed all ofthe DAIG
inspections except for the 201 inspection (failed due to the three erroneous Botulinum
neurotoxin A shipments discussed in Section 1.F.3 above). Minor de?ciencies were noted
during each inspection, but only the 2011 inspection identi?ed a de?ciency. In advance
of each biosurety inSpection,23' ATEC, with support from DTC, conducted Special Team
Reviews and Staff Assistance Visits at to ensure that all minor deficiencies from the
previous inspection had been remediated. Details of each inspection are provided in the
paragraphs below.

The initial DAIG inspection in 2005 was an unrated review meant to facilitate the
establishment of a proper surety program.232 In 2007, the first formal DAIG Biological Surety
Inspection was conducted. Highlighted in that inspection was a tendency for DPG-LSD to simply
react to a specific ?nding, not necessarily look for the root causes of the problem, but overall
DPG was assessed as accomplishing its surety missions in a safe and secure manner?? The
2009 Biosurety InSpection Specifically noted inattention to detail as an issue, but the report
reached the same ?safe and secure? conclusion as in 2007.234 in 2011, DPG-LSD failed the
DAIG inspection due to the erroneous shipment of Botulinum neurotoxin A discussed earlier in
this report (see Section This was the first biosurety inspection conducted in conjunction
with the CDC Federal Select Agent Program as part of a federal effort to reduce the inspection
workload on laboratories.235 In 2013, the DAIG found DPG to be ?proficient in all functional
areas? but had 13 observations that needed to be addressed including a lack of focus on the
calibration of test, measurement, diagnostics, and evaluation equipment.286 In 2015, the DAIG
and CDC conducted a third joint inspection of The team found five minor

 

27" See Select Agents and Toxins, 42 CPR. pt. 73; Possession, Use, and'Transfer of Select Agents and Toxins, 9
C.F.R. pt. 121; and Possession, Use, and Transfer of Select Agents and Toxins, 7 C.F.R. pt. 33].

23? See Tab E-l, AR 50-1, para. Tab E-2, U.S. or ARMY, REG. 190-17, BIOLOGICAL SELECT AGENTS AND
TOXINS SECURITY PROGRAM, para. (3 Sept. 2009) [hereinafter AR 190?17]; DA PAM 385-69, para. 

28? At a minimum. The 15-6 investigation team did not coilect documentation on every ATEC Staff Assistance Visit
to DPG-LSD, so there may have been more visits conducted for other reasons.

232 See Tab 033, DAIG BSI, 2005.

233 See Tab 034, DAIG BSI, 2007.

23? See Tab 035, DAIG BSI, 2009.

285 See Tab C-36, DAIG BSI, 2011.

236 See Tab 037, DAIG BSI, 2013.

57

de?ciencies in the areas of safety, three in security, and two in emergency response, but overall
assessed that DPG was accomplishing its mission ?to standard?.287

The ?ndings and overall message conveyed by each individual report was that 
was accomplishing its mission in a safe and secure manner. It is reasonable that DPG, DTC, and
ATEC leadership did not initiate any formal investigations into the minor de?ciencies at the time
ofeach inspection. However, a holistic review ofthe DAIG reports from 2005-2015 shows that
inattention to detail complacency) has been a common problem at DPG-LSD since at least
2007.

c. Army Safety Inspections

Army safety inspections are compliance or program based. There are three primary safety
inspections that apply to Army facilities and organizations that utilize microorganisms:

1. Organizational Inspections
2. Standard Army Safety and Occupational Health inspections
3. Laboratory Compliance Inspections

The ?rst type of safety inspections are organizational inspections that evaluate the integration
of the Army Safety Program into the organization?s mission. Organizational inspections
measure the overall effectiveness Army Safety Programs into an organization?s business
processes and mission execution. This is a formal inspection conducted by the parent command
every 36 months at the minimum. These evaluations are programmatic assessments, and are
planned and announced as part of the parent commands organizational inspection program. In
addition, these inspections focus on Army safety program elements and do not include scienti?c
reviews of protocols or procedures.288

The second type of inspection, the Standard Army Safety and Occupational Health
Inspection, is a workplace inspection. The primary focus of this inspection is to evaluate
implementation and maintenance of safety and health standards. The inspection is conducted
annually by quali?ed safety and occupational health professionals or specially trained personnel
competent to conduct the inspection. The Standard Army Safety and Occupational Health
Inspection can be either announced or unannounced and it does not address scienti?c details,
process reviews, technical procedures, or protocol reviews.289

The third type of safety inspection applies to laboratories that utilize infectious agents and
toxins. Given the sensitivity of the materials handled within these labs and the fact that the
materials are regulated, the laboratories must undergo inspections evaluating compliance with
general safety practices as well as requirements applicable to the laboratory?s biological safety
level. These inspections are conducted by the safety of?cer, biosafety of?cer, or quali?ed safety
and occupational health personnel designated by the Commander/Director and can be announced

 

237 See Tab C-38, DAIG 2015.
333 See AR 385-10, para. 2-10.
239 See AR 385?10, para. 17?6.

58

or unannounced. Biosafety level-2 and toxin laboratories must be inspected at least semi-
annually. Biosafety level-3 laboratories, and those in which dry forms of toxins are handled, are
inspected at least quarterly.290 These laboratory inspections utilize a checklist and do not go into
scienti?c details or protocol reviews. Inspectors conducting these inspections may or may not
have academic backgrounds in science or possess operational laboratory experience.

d. Technical Quality Audits

In addition to the inspections described above, the 15-6 investigation team was made aware of
a two-week technical quality audit conducted by a single auditor from the Camber Corporation at
DPG-LSD in 2004. The audit, Sponsored by the CRP Management Of?ce at Fort Detrick,
focused on quality management of CRP processes and addressed antigen variability and product
safety.291 The audit resulted in several recommendations that facilitated improvement of the
antigen production and irradiation processes through studies executed by the science and
technology community.292

e. Summary

There are two common themes among the inspections that are conducted on a regular basis.
First, the majority of inspections are announced which allows laboratories to exhaustively
prepare for the inspection and curtail work during the inspection to reduce the risk of a negative
?nding. Second, federal, biosurety and safety inspections do not review the scienti?c details of
agent inactivation and the viability testing protocols since they are focused solely on
compliance.293 However, the results of the 2004 technical audit conducted by the CRP
management of?ce show that it is possible to conduct inspections/audits addressing targeted
scienti?c details over a similar timeframe as the existing inSpections. These technical reviews
are value-added and have the potential to minimize the likelihood of future mistakes.

C. Individual Accountability

Failures by leadership, oversight staff, and laboratory technicians were identi?ed across the
DPG-LSD enterprise. These failures may have contributed to the inadvertent shipment of viable
Bacillus anthracis. There is not a direct causal link between any of the failures identi?ed and the
inadvertent shipment of viable Bacillus anthracis, however, the failures represent a complacent
environment which may have allowed for the inadvertent shipment to occur. Section 1 below
identi?es the failures by leadership, oversight staff and laboratory technicians. Section 2
identi?es responsible parties and summarizes individual culpability for failures and de?ciencies

 

29? See DA PAM 385-69, para. 3-10.

29' See Tab C-24, Critical Reagents Program, CBMS-MITS Quality Site Audit, US. Army Dugway Proving
Ground, Antigen Repository (27 Jan. 2004).

292 See Tab 840.2, (mm, DA Form 2823, Sworn Statement (30 Sept. 20l5).

7'93 See Alison Young, Top US. lab regulator replaced in wake of incidents with bioterror pathogens, USA TODAY,
Dec 08, 20l5. Dr. Robbin Weyant was replaced as the Direct0r of the CDC Division of Select Agents and Toxins,
partially due to the fact that an internal CDC review found that the federal inspections were ineffective, and
?focused too much on paperwork and bureaucratic minutiae, rather than meaningful measures of safety and
security.?

59

that caused a complacent environment. Organizational charts for DPG and DPG-LSD are
provided for reference in Appendix ofthis report.

1. Leadership, Oversight Personnel, and Laboratory Technicians Failures and
De?ciencies

A preponderance of evidence does not exist to definitively attribute culpability for the
inadvertent shipment of viable Bacillus anthracis to an individual or group of individuals.
However, observations make clear that a lack of strong leadership at DPG-LSD has fostered an
environment of complacency, and that DPG-LSD personnel have been selective in following
rules, regulations, and procedures. These failures were exhibited across the spectrum of
personnel at DPG-LSD including leadership, oversight staff, and laboratory technicians and
some of the failures may have wan~anted disquali?cation from the biological personnei reliability
program under the provisions of Army Regulation 50-1, Biological Surety, chapter .2.294 These
failures and de?ciencies are discussed in detail below.

a. Manipulation and Carelessness in Generating Bacillus anthracis Death Certi?cates

The 15-6 investigation team found evidence that altered death certi?cates
after they had been signed and approved by the Principle investigator, the Biological Safety
Of?cer, and the Responsible Of?cial in Test Mission Support System (a SharePoint tool
used to automate and control the death certi?cate staffing process). made these
changes without notifying these individuals.295 For example, the death certi?cate for lot
A000001667 was si ed (6)

(6) on 18 March 2014. Normally, there
is only one death certi?cate for each lot. However, there were three versions of the death
certi?cate for lot AGD0001667. Each version has a different date of sterilization and radiation
dose (124.02 kGy on 12 December 2013, 107.99 kGy on 16 December 2013, and 119.6 kGy on
16 December 2013).296 The investigation found that all three of the radiation doses were
incorrectly calculated. 1f calculated correctly in accordance with the total dose
should have been 1 15.96 kGy.

  

While these could have been administrative changes made to correct inaccurate information,
such changes should have been made prior to the finalization of the death certi?cates.297 The

 

29? Certi?cation in the biological personnel reliability program is required for an individual to have access to
biological select agents and toxins. Negligence or delinquency in the performance of duty are potential grounds for
disquali?cation, based on the certifying of?cial?s informed judgement. See Tab 8-2.1, 
Form 2823, Sworn Statement (21 Aug. 2015) where ma- states that he is the certifying of?cial for the DPG
biological perSOnnel reliability program and has disquali?ed three individuals for conduct not related to these
incidents, but has not disquali?ed individuals involved in the growth, irradiation, viability testing, or shipping of
biological material. See also Tab B-27.2, page DA Form 2823, Sworn Statement (20 Aug.
2015) where m- acknowledges that indivr ua 5 per unsafe or questionable laboratory practices
should be considered for removal from the biological personnel reliability program, but did not believe any of his
perSOnnel ?t that pro?le.

295 See Tab B-44.i.a, page 5, (6) Addendum to DA Form 2323, Sworn Statement (19 Aug. 2015).

29" See Tab C-20, Discrepant Death Certi?cates (Lot 

See Tab B?26.1.a, page 4, (6) Addendum to DA Form 2823, Sworn Statement (19 Aug. 2015).

60

fact that the date/time stamp for each of the three signatures is the same on all three versions of
the death certi?cate shows that these changes occurred a?er the original document was signed by
all parties. (6) indicated that the content of the death certi?cate form cannot be
modi?ed after the Responsible Of?cial signs it unless the signatures are removed. Once the
signatures are removed and any modi?cations are made the form must go back through the
review process and be re-signed (thereby creating a new date/time stamp).298

The 15-6 investigation team questioned about these multiple death certi?cates.
To the team?s surprise, stated that as the Principle Investigator she had permission to
edit the death certi?cate after the document was signed by all of the parties.299 Additionally, she
indicated that an initial death certi?cate is produced in order to move a lot, for example
AGD0001667, out of biosafety level-3 in order to prepare the sample for shipping to a
customer.300 Prior to shipping, (6) stated that she prepares a ?nal death certi?cate by
taking the existing certi?cate off of the database, saving it to her desktop as an editable Adobe
PDF ?le, and adds clarity by including the ?nalized data the form needs (average irradiation
amount and time of exposure). circumvented the system by preserving the original
valid signatures that the approving of?cials placed on the initial death certi?cate. As the
Principle Investigator she believed that she did not need to get the document resigned to make
these administrative changes. 30?

Additionally, when questioned about herjusti?cation as it pertained speci?cally to lot
(6) rationale fell apart. She stated that an initial death certi?cate was
created to move a sample from biosafety level-3 to the biosafety level-2 laboratory.302 However,
(6) stated that lot AGD0001667 was moved out of biosafety level-3 in January a?er
completing viability testing. At this time, had all ofher laboratory notes and data
related to inactivation and viability testing documented in her laboratory notebook.303 However,
did not create the death certi?cate for this lot until March.304 tried to
explain this discrepancy by stating that she often prepared death ceni?cates in batches, which
directly con?icts with her statement that an initial death certi?cate was created to move a sample
out of biosafety level-3.305 Moreover, it was unnecessary to prepare an initial and ?nal version
of the death certi?cate for lot because all of the necessary data needed to complete
the certi?cate existed in January.

The preponderance of the evidence indicates: (l was trying to provide an excuse
to cover her inattention to detail and resulting administrative errors on the death certi?cates; (2)
ubverted the intent of the Test Mission Support System by downloading death
certi?cates in Adobe format and manually modifying them with the original signatures and
date/time stamps still intact; and (3) DPG-LSD had signi?cant failures in properly preparing,
managing and approving death certi?cates.

298 See Tab 8-372, 6 DA Form 2823, Sworn Statement (19 Aug. 2015).
299 See Tab 3?44.23, page 6, (6) Addendum to DA Form 2823, Sworn Statement (19 Aug. 2015).

 

30? See Tab B-44.1.a, page 5, (6) Addendum to DA Form 2823, Sworn Statement (19 Aug. 2015).
30] [d
302 

303 See Tab 8-5. I page 5, mm, Addendum to DA Form 2823, Sworn Statement (20 Aug. 2015).
See Tab 020, Discrepant Deat em icates (Lot 
30? See Tab B-44.2.a, page 6, (6) Addendum to DA Form 2323, Sworn Statement (l9 Aug. 2015).

61

b. Failure to Take Action

Despite multiple shipping errors and incidents/mishaps within their labs, DPG leadership and
DPG-LSD management repeatedly failed to conduct proactive internal investigations, take
disciplinary action, or institute re-trainin when warranted. Instead, the observed response of
DPG leadership and DPG-LSD management was to blame external entities or to downplay the
seriousness of the associated actions and accusations. They only instituted reactive corrective
actions to the immediate incident and did not consider potential indicators and de?ciencies in
related processes across the organization. These failures to act fostered a sense of
complacency306 which may have indirectly contributed to the inadvertent shipment of viable
Bacillus anthracz's. The following paragraphs discuss the various failures to take action in detail.

i. Failure to Investigate and Hold Personnel Accountable for
Biological Mishaps

A key example of failure to investigate and hold personnel accountable is the DPG-LSD
response to the 2007 shipment of viable Bacillus anthracis to the Lawrence Livermore National
Laboratory, described in detail in Section l.F.1. In response to a question about what
disciplinary action was taken in light of the ?nes levied on DPG-LSD by the CDC,

mystated that no disciplinary actions were executed.307 The DPG-I.SD maintained
roug out that the most likely cause of this incident was contamination in the receiving lab at
LLNL despite the CDC ?nding that DPG-LSD failed to properly inactivate the spores and/or
prevent contamination at its facility.308 While it is possible that contamination at LLNL was the
root cause, it is clear that UPC-LSD did not conduct an exhaustive self-examination of their
personnel and procedures to arrive at this conclusion, particularly in light of the fact that one of
the ?ve sample tubes contained viable spores and was discarded via autoclave prior to shipping
the other four tubes.

On 28 April 20085ent a memorandum (the
investigating attorney at the for the LLNL incident) indicating that he had direct
knowledge that the ?fth tube was ?cloudy with contamination? during viability testing}09 The
[5-6 team, CDC, and consider this tube to be a critical piece of evidence. If the
?fth tube was contaminated, it is not possible to determine with 100% certainty that the viable
ore eventually found at LLNL did not also come from DPG-LSD. This fact was dismissed by

and resulted in acceptance of the advice of the DPG-LSD staff at face value
without further investigation into the potential root cause of the incident.

Subsequently when rendered the ?nal judgment on the LLNL incident on 2
December 2009, Colonel William King also relied upon the DPG-LSD staff for information and
failed to investigate the issue. As described in Section l.F.1, Colonel King directed (6

 

306 See Tab 8-2. I page 18, Addendum to DA Form 2823, Sworn Statement (21 Aug. 2015(6) Enclosure 2 to DA Form 2823, Sworn Statement (21 Aug. 2015).
309 See Tab C-4 1 pgs. 61

-64, LLNL Correspondence and Evidence

62

 (6) to ?prepare a response and discussion? summarizing the LLNL incident. There is
evidence that failed to communicate the presence of contamination in the ?fth tube
to Colonel King in this response. However, Colonel King also indicated in recorded testimony
that he did not review all of the historical correspondence associated with the incident compiled
during 2007?2008 prior to his taking command at A thorough review of the historical
documentation should have been the first step in a formal inquiry, and would have provided him
with knowledge of the contamination. It is a reasonable expectation for a commander to
investigate the potential root cause of the incident, especially in light of the fact that the 
010 was authorized to impose a civil monetary penalty against DPG-LSD of up to $500,000.

In addition to the LLNL incident, Section LP and Figure 9 detail eight additional incidents
involving the inadvertent, incorrect, or improperly documented shipment of various biological
materials from DPG-LSD in the time period between 2007-present. Although DPG-LSD
implemented corrective actions to their processes (with questionable success) in response to each
of these mishaps, they neglected to initiate formal inquiries, investigations, or disciplinary action
on any of the personnel associated with the incidents. This is in spite of the fact that heavy civil
penalties were recommended by the DHHS-OIG in the case of the Botulinum neurotoxin A
shipments. The process improvements implemented in response to each incident were not
suf?cient to prevent recurrence of similar incidents in the future and formal disciplinary action in
the form of re-training or counseling may have been more effective. repeated
failure to hold personnel accountable is an indication that leadership may not fully understand
the criticality of the operations they conduct and contributed to each subsequent mishap,
inciudin the current shipment ol?viable Bacillus anthracis.

ii. Failure to Hold Personnel Accountable for Poor Laboratory
Practices

(5) failed to take appropriate

action in response to multiple accusations of unsafe laboratory practices involving its
personnel.312 in reSponse to a question about whether or not anyone on his team had ever
complained about unsafe laboratory practices involving his personnel, (6) admits that
he did in fact receive such a complaint from (6) in relation to aseptic
procedures.?3 Instead of dealing with the complaint directly, (6) contextualized it by
referencing on-going animosity between and (6) as a potential explanation.
He also referenced what he believes to be an innate tendency of scientists to constantly question
the skills of their colleagues as a reason why the accusation did not need to be taken seriously.314
decision to not take action against (6) in response to a single complaint is
reasonable considering that he believed the complaint may have been unfounded. However,

  
 

 

?0 Colonel King took command at DPG in July 2009 after (6) relinquished command, and 
becamc the Director of DPG-LSD in 2008 after (6) retired.

3? See Tab 8?232. pg. l7, Memorandum for Record. subject: Transcribed Testimony of 80 William E. King, IV
(10 Nov. 20l5.

3'2 Wprovided evidence that he has formally disciplined two DPG-LSD employees for oor laboratory
practices not related to this investigation, but there was no evidence that he ever disciplinedmi

3'3 See Tab B-27.2., page I, (6) DA Form 2823, Sworn Statement (20 Aug. 2015).
Id.

63

subsequent to this, and also documented in his statement, (6) admits that two other
?prominent? biosafety level-3 lab workers expressed concerns about (6) lab
practices.315 These additional complaints did not prompt any formal corrective action against
(6) nor did they prompt to consider using the resources available to him
(such as surveillance video recordings of activity in the biosafety-3 laboratories) to verify the
legitimacy of the complaints. Given that (6) eventually played a role in the inadvertent
shipment of viable Bacillus anthracis, the failure of to take action in
response to the numerous complaints received about her poor lab practices represents a key
missed Opportunity.

Failure to Reasonably Identify and Correct Long-Standing
Deficiencies

It is now known that the unintended shipment of samples with low concentrations of viable
Bacillus anthracis spores was a long-standing problem dating back to 2004. It is critical to
follow validated processes, procedures and protocols when operating in a highly-regulated, zero-
defect environment required to work with biologicai select agents and toxins such as Bacillus
anthracis. [t is also necessary and reasonable to assess past inactivation results through a
thorough review of prior inactivation events in order to understand whether established protocols
and procedures are effective. Figure l7 presents a comparison of data contained in the death
certi?cates for the 33 lots of Bacillus anthracis originally irradiated between 2004 and 2015
which remained in the DPG-LSD inventory in May 2015. These lots we re-ehecked for viability
on 26 May 2015 following the incident reported on 22 May 2015 (note that death certificates
were not available for two of the 33 lots). Figure l7 shows that of the 33 lots of irradiated
Bacillus anthracis retested for viability, over 50% (17 of 33) showed viability when using the
revised protocol provided by the CDC .3'6 This data demonstrates that DPG-LSD had a long-
standing, widespread problem that they failed to reasonably recognize or correct.

 

?5 See Tab B-27.2., page I, My, DA Form 2823, Sworn Statement (20 Aug. 2015).

3? See Tab 5-7, Centers for Disease an Control Prevention, Revised Viability Testing Protocol for Samples of
lnactivated Bacillus anthracis (20 5).

64

 

 

 

 

 

 

 

 

 

Death Date toll! Hot? Project Safety Responsible SOP on kGy
Conilicate Officer Official DTC
01(0105 1/22/04 4600000069 . 147 V2: 0
01(0105 1/22/04 4600000070 147Vc-r 0
01(0121 8/8/04 4600000515 . 14 1 Ver 0
01(0121 8/8/04 4600000511 147Ver 0
DTC0121 8/8/04 4600000516 147Ver 0
01(0194 7/28/05 4600000644 147 Ver 0
01(0195 7/28/05 4600000648 14 7 0
DIC0241 4/17/06 4600000174 147Ver 0
01(0242 4/17/06 4600000778 147 Ver 0
01(0751 4/17/06 4600000790 147 Ver 0 48.78
07(0252 4/17/06 4600000794 147Vm 0 45.48
01(0253 4/17/06 4600000798 147Vcr 0 45.48
DTC0257 4/17/06 4600000806 147 Ver 0 45.41
07(0258 4/18/06 4600000810 147 Ver 0 52.93
01(0268 6/1/06 4600000830 147 Ver 0 43.32
01(0264 6/1/06 4600000822 147 Ver 0 45.74
01(0278 8/23/06 4600000858 147 V21 0 46.7
01(0286 8/23/06 4600000862 14 7 Ver 0
01(0310 10/25/06 4600000910 147 Ver 0
DTC0382 10/2/07 4600000950 4959
01(0383 100/07 4600000954 4959
01(0430 10/18/07 4600000999
01(0498 8/4/08 4600001039 147 Ver 1
DTC0497 8/5/08 4600001035 147Ver 1 43.29
(?(0572 5/18/09 4600001151 147Ver1
01(0670 11/4/10 4600001331 5758
01(0723 10/29/12 4600001435 43.08
DTCD727 10/29/12 4600001451
07(0803 3/18/14 4600001667 119.6-
Not Available 4600001575
DTC0791 9/9/14 4600001631 44.61
Not Available 4600001127
01(0825 4600001675 $0.96
Colum tested positivein 2015, Novlheselots tested negative in 2015
Column (SOP on Death Certi?cate): Red-Version of on the Death Certificate does
not match thevenion in diet! at the time
Columl (kGy): GeemDose was within 4012 kGy target dose. Red: Dose was lower than 4012 kGy
target dose, Yellow: Dose was higher than 4012 kGy target

 

 

Figure 17: Analysis of Data Contained in 3 I Death Certificates

Based on the data in Figure l7, there is no correlation between the viability test failure rate
and the protocol or radiation dose. First, the viability testing failure rate for both the DPG-LSD
standard protocol (WDL-BIO- 47) or work instruction (C varied from 56-42%
respectively. Both failure rates using either protocol are unacceptable and statistically
signi?cant. Second, eight of the l7 samples that eventually tested positive for viable spores were
treated with a radiation dose above the target dose ol?40i2 kGy while one ?hot? sample received
a low dose (36.5 kGy). More specifically. lot reportedly received I 19.9 kGy and
was ultimately still viable when re-testcd in 2015 whereas lot AUD0000778 received 38.66 kGy
and proved to be inactivated upon re-testing. Clearly. the data available from DPG-LSD does
not correlate to a root cause of the unintended shipment of viable Bacillus anthracis spores.

The evidence presented in Figure l7 suggests: gaps in science exist as there does not
seem to be any correlation between historic radiation doses (above or below the target dose of
40:2 kGy) and overall inactivation success; (2) DPG-LSD protocols were completely
inadequate; (3) there was a widespread contamination issue present at DPG-LSD which affected

65

various lots over time; or (4) the information is erroneous. Regardless, DPG-LSD personnel
could have tabulated the data in Figure 17 and acted upon it if critical process reviews were
being conducted. This demonstrates of DPG-LSD’s failure to identify and correct long-standing
deficiencies in their processes. In addition to the personnel whose names appear in Figure 17,
particularly the Responsible Officials, the technical leadership ((b) (6)
.
(b) (6)
) within DPG-LSD missed an opportunity to review the data, recognize trends,
and potentially recognize problems with the inactivation and viability testing processes before a
mishap occurred.
iv.

Failure to Adhere to Production-Based Practices

The mission of the CRP team at DPG-LSD is to produce and distribute inactivated antigens
for the CRP catalog in support of the CRP’s role in serving as a broker for government, industry,
and academia customers. 317 This mission is unique within DPG-LSD and in the ATEC
community as a whole in that the CRP team produces material on a relatively large scale basis
and ships it to external customers (as opposed to small production runs of biological material
used to support specific, customer funded research in other DoD labs). The DPG-LSD failed to
institute the rigor and control mechanisms required to create a repeatable production-based
environment. 318
Since the discovery of viable Bacillus anthracis on 22 May 2015, production as a core
competency is being questioned at the highest levels of leadership within the ATEC. In a
memorandum dated 20 July 2015, the ATEC Commander, Major General Daniel Karbler,
requested that the Vice Chief of Staff of the Army transfer the mission for the production and
shipment of antigen material from DPG-LSD to an alternate centralized provider. 319 When
questioned about the motive for this request, Major General Karbler indicated that he does “not
believe that production and shipment of antigen material is a core competency of ATEC.” 320
The current Deputy to the Commander and Technical Director of ATEC, Mr. David Jimenez,
echoed this sentiment. 321 The evidence suggests that CRP personnel at DPG-LSD operated with
a research, test, and development mindset as opposed to a production mindset for the duration of
the CRP’s existence. The personnel at DPG are primarily trained and experienced in scientific
research, development, and testing which is in-line with the overall ATEC mission. However,
since CRP personnel are involved in production processes that create biological products for
external end-users, their concentration should have been on the conduct of rigorous
methodologies and requirements associated with controllable and repeatable production.
The CRP Antigen Repository at DPG-LSD (not DPG-LSD as a whole) is certified to
International Standards Organization Guides 34 322 and 17025. 323 Guide 34 documents the
317

See Figure 4.
See Tab E-3, U.S. DEP’T OF ARMY, REG. 702-11, ARMY QUALITY PROGRAM (25 Feb. 2014).
319
See Tab C-29, Memorandum Thru Lieutenant General Gary H. Cheek, Director of the Army Staff; for General
Daniel B. Allyn, Vice Chief of Staff of the Army, subject: Specific Recommendations for OSD Comprehensive
Review: Production and Shipment of all Antigens from U.S. Dugway Proving Ground (20 July 2015).
320
Tab B-22.1, page 2, Daniel Karbler, DA Form 2823, Sworn Statement (25 Aug. 2015).
321
See Tab B-20.1, David Jimenez, DA Form 2823, Sworn Statement (10 Sept. 2015).
322
See Tab C-39, General Requirements: Accreditation of ISO Guide 34 Reference Material Producers (June 2010).
323
See Tab C-40, General Requirements: Accreditation of ISO / IEC 17025 Laboratories (Feb. 2015).
318

66

 general requirements for accreditation of Reference Material Producers. A reference material is
any material that is used as a ?control? in a test or measurement process. Certi?cation of
reference materials (assurance that a reference material is of a known composition) is of critical
importance to chemical and biological testing as most analytical instruments and assays are
comparative in nature, so they require ?accurate? reference materials to be effective. Guide
[7025 accredits test and calibration procedures, and is essentially the standard by which the
technical competence of the laboratory is assessed.

Certi?cation to Guides 34 and 17025 represents a signi?cant accomplishment for the CRP at
DPG-LSD, but these certi?cations do not cover the entirety of the production process employed
by the CRP for Bacillus anthracis. speci?cally the irradiation process.324 Furthermore, these
lntemational Standards Organization standards do not de?ne requirements and best practices for
industrial production operations for external customers. As a result, the CRP production activity
operated under the assumption that it was in compliance with acceptable standards for
production, when in reality several gaps existed. Prominent among these gaps are: 1) No
de?ned process change/con?guration control plan; 2) No scheduled critical reviews of process
data and metrics; and 3) No dedicated Quality Manager.

I) No De?ned Process Change/Con?guration Control Plan

All of the gaps identi?ed above may have played a role in the failure to inactivate CRP lot
which triggered this investigation. During witnss interviews and inspection of
laboratory notebooks, the investigation team discovered that executed an
unauthorized deviation from the accepted irradiation process while irradiating lot
667.325 The irradiator in service at DPG-LSD is a Shepherd model 484-R2
Gamma lrradiator. This model employs three ?xed Cobalt 60 radiation sources located at the
rear of the main irradiation cavity (encapsulated in stainless steel tubes) that can be individually
selected/deselected (turned to control the radiation dose. Samples are placed on a
turntable inside the cavity that rotates at a constant speed to ensure that each sample is uniformly
exposed to the radiation. Figure 18 depicts the irradiator in use at DPG-LSD.

 

mediator (Externall lrradiatorllmernal - Turntable Removed)

 

 

 

 

Figure 18: Shepherd 484-R2 Gamma Irradiator at DPG-LSD
?24 See Tab B-44.l.c, (bl Enclosure 2 to DA Form 2823, Sworn Statement 8 Aug. 2015).
See Tab page (D) Addendum to DA Form 2823, Sworn Statement (18 Aug. 2015).

67

 

Since 2012 the irradiator experienced several and since there was no
maintenance/calibration contract in place, performed repairs himself and modi?ed the
irradiation process to keep the production line moving. Dru?ing irradiation of lot ADG0001667,
the truntable was inoperative, so decided to manually rotate samples 180 de ?ees
halfway through irradiation to compensate. In his 20 August 2015 sworn statementW
stated:

Here testing that falls outside the norm. We are sometimes
required to design test apparatus that meets the customer needs. Troubleshooting
and validating is often required. At times we are faced with the necessity of
?nding?xes or workarounds that enable the continuation of the test without
compromising safety or the integrity of the data. 327

These actions are a testament to ingenuity and dedication to timely mission
completion, and are reasonable ?'om the perspective of a tester. However, these actions are not
in-line with controlled production environments, where changes to the baseline processes must
be vetted to ensru'e repeatable results.

(6) stated that he consulted with other DPG-LSD ersomrel who also operate the
irradiator (6) for his proposed
workarormd, but there was no formal process required to vet and approve this coru?se of action.
(6) manager, (6) was not irmnediately made aware of the issue-7?29 This
process deviation demonstrates how the RP Antigen Repository was executing more as a
research and development activity as opposed to a production facility mandated to maintain a
controllable, repeatable process.

  
 
  

328

 

2) No Scheduled Critical Reviews of Process Data and Metrics:

One of the most critical activities required to maintain a defect-free, controlled, and
repeatable production process is the collection and periodic review of critical process data and
metrics. Production data and metrics can be used to proactively monitor the status of a
production process, identify de?ciencies in the process, and correct them before end products are
affected. The RP team at DPG-LSD does not conduct these formal, recurring data reviews, and
missed opportunities to proactively identify inadequacies in the inactivation process that could
have contributed to the inadvertent shipment of viable Bacillus anthracis spores.

The following example considers data collected, but not formally and critically reviewed by
the RP team, on radiation doses for various lots of RP material since 2003. Figru'e 19 is a plot
of Radiation Dosage vs. Lot Date for lots of Bacillus anthracis created by the 15-6 investigation
team with data provided by the RP.

 

326 Id
327 See Tab B-4.2..
328 Id. See also Tab B-35.2.
329 See Tab B-27.2.a.. page 4.
When nrade aware of the issue.
irradiated?. indicating that he disagree
superiors.

   
 
  
  
  
    

. DA Form 2823. Sworn Statement (20 Aug. 2015).

. DA Form 2823. Sworn Statement (20 Aug. 2015).

. Addendum to DA Form 2823. Sworn Statement (20 Aug. 2015).
stated that it would ?be corrected before any more materials were
decision to rotate the samples without consulting his

68

 

to: [1.767

.n 

Reclaim Dose k6
I


I

II
I

Let Dale

 

 

 

Figure 9: Critical Reagents Program Lots Radiation vs. Lot Date

A review ofthis plot shows a process that is inadequate and not in control. According to
DPG-LSD standard operating procedure (rev 8), the radiation dose required to
inactivate gram positive bacteria such as Bacillus anthracis is 40:2 kGy.330 Several lots of
material received doses both above and below the standard dose required to achieve inactivation.
In cases where lots of material required far in excess of the standard dose. including lot
which received nearly three times the documented required dose,?? the samples
were exposed to additional radiation alter displaying growth alter initial irradiation.

In the course of the investigation the 15-6 investigation team discovered that the ?failure
rate? for the irradiation process, that is. the rate at which samples need to be re-irradiated because
growth is observed during viability testing after initial radiation, is in the range of 

 

33" See Tab C?l . 
?'id not implement a standardized scienti?c methodology or protocol when irradiating lot
Since the turntable was broken at the time of the initial irradiation, he developed remedial measures
to irradiate this sample. The evidence collected does not indicate that he had a scienti?c basis for how much
radiation to expose this lot to. For the ?rst exposure. he estimated the exposure time for a half dose. stopped the I 
irradiator, manually turned the sample. and continued irradiating it for the remaining time. See Tab B?al. 
Addendum to DA Form 2823. Sworn Statement 18 Aug. 2015). The normal dose, as noted above. should be
40:2 kGy. However, it received an average dose of 59.8 kGy during the ?rst exposure. ?xed the
turntable after irradiating this lot while (6) conducted viability testing. During viability testing lot
showed growth for viable spores and had to be irradiated a second time. Any lot which requires a
second dose of irradiation for inactivation should receive a maximum total average exposure of 80:4 kGy (40 kGy
for each of two irradiation runs). However, this lot received an average dose of56.16 kGy for the second exposure
and a total average exposure of I  5.96 kGy from both ex osures (this number does not match the data annotated on
the four death certi?cates for this lot, becausemncorrectly annotated the exposure). This amount is nearly
three times the normal dose of gamma radiation from only two exposures. See Tab 8-44. I lb) 
Addendum to DA Form 2823. Sworn Statement (l8 Aug. 2015).

"1 See Tab 8?2. I pa 8. (6) Addendum to DA Form 2823, Sworn Statement (21 Aug. 
Tab B-27.l.a.. page S. (5) Addendum to DA Form 2823. Sworn Statement l8 Aug. 20l5): Tab B-
352. (6) DA Form 2823. Sworn Statement (20 Aug. 20l5).

69

Since 2003, a total of 483 vials of Bacillus anthracis have been irradiated by DPG-LSD.
Twenty-nine vials have exhibited growth post irradiation - a 6% (29/483) failure rate.?3 The
483 vials were distributed across 156 lots. Twenty~two lots contained vials that exhibited growth
post irradiation - a 14% (22/156) failure rate.?4 Additionally, (6) a non-CRP DPG-
LSD employee who was utilizing the same inactivation standard operating procedure as the CRP
does for his work, states that approximately 20% of the irradiation runs he
conducted on Bacillus anthracis strains required re-irradiation.33S Combined, these percentages
provide an estimated failure rate in the range of 

A failure rate anywhere in this range is considered unacceptably high for a controlled,
repeatable production process, and clearly indicates that the baseline process is inadequate. The
DPG-LSD staff feels as though this failure rate is acceptable due to the balance required when
trying not to over-irradiate Bacillus anthracis samples,336 but it is not clear that they critically
considered the data until after the current investigations began. Furthermore, the presence of
both ?passed? and ?failed? vials within a single irradiation lot clearly indicates that the
inactivation process is not repeatable due to inherent, uncharacterized variability. If formal,
recurring process data and metrics reviews had been instituted by the CRP team, it is likely that
they would have realized that the inactivation process was not adequate and that shipment of
viable material was possible.

3) No Dedicated Quality Assurance/Quality Control Manager

Finally, DPG-LSD lacked a dedicated Quality Assurance/Quality Control manager. At DPG-
LSD, Quality Assurance/Quality Control was considered an overhead ?mction not billable to
customers. As a result of funding cuts, DPG-LSD terminated a contractor position for dedicated
Quality Assurance/Quality Control in 201 1 because they could not defend the necessity of the
billet.337 The DPG-LSD management (5) were aware of the
problems associated with losing this dedicated Quality Assurance/Quality Control position.33
Subsequently, to compensate for the lack of a full-time Quality Assurance/Quality Control
person, DPG-LSD leadership assigned the roles and responsibilities for CRP Quality
Assurance/Quality Control to (6) as an additional duty.339 This created a conflict of
interest due to the fact that also the production technician for the CRP. in essence,
leadership placed her in a position where she was responsible for both oversight and execution of
the inactivated antigen production processes. This was a questionable decision by

8

 

3? See 'l?ab B?2.1.e, (bl (6) Enclosure 4 to DA Form 2823. Sworn Statement (21 Aug. 2015).
334 

?35 See Tab B-35.2, (6)
336 See Tab B-2.1.a, page 8,

 
  
  
 
  
 

DA Ferm 2823, Sworn Statement (20 Aug. 2015).

Addendum to DA Form 2823, Sworn Statement (21 Au . 2015).
337 See Tab 3-2.1, page 2, DA Form 2823, Sworn Statement (21 Aug. 2015). 
states that he tried tojusti posrtion as ?inherently government" when the contractor was lost, but was
unsuccessful in having the position added to his TDA. The extent ofj ustitication he provided is not clear.

3? Id. See also Tab B-27.2, page 2, Addendum to DA Form 2823, Sworn Statement (20 Aug.
2015). These problems include lack of unbiased, external review procedures. (6) ndicates

that he believes the issues involvin death certi?cate accuracy may have been caught by a dedicated ualit erson.
33" See Tab Elam DA Form 2323, Sworn Statement (02 Sept. 2015); Tab Bantam
DA Form 2823, Sworn Statement (20 Aug. 2015).

70

leadership given the fact that (6) duties occur in a production environment where
independent Quality Assurance/Quality Control is critical.

In summary, the CRP team is unique amongst the DPG-LSD and overall ATEC community
in that it is engaged in the production of biological material for external customers. As a
production team, it must ensure that its processes are not only safe, but also controllable and
repeatable. Achieving this balance requires a level of rigor beyond that which is employed by
laboratories engaged in in-house production and testing only, particularly as it relates to process
change control and data collection and review. While production may not be a core competency
of ATEC, if the production mission is to remain at DPG-LSD it must be treated as such and
resourced appropriately so that the proper level of rigor may be applied to ensure that the process
remains safe, controllable, and repeatable. The evidence collected suggests that was
not aware ot?and did not implement the Army Quality Program.340

v. Failure to Account for Contamination

The preponderance of the evidence cannot rule out contamination as a potential root cause for

the shi ment of Bacillus anthracis that was discovered on 22 May 2015. Several individuals
PIE?questioned the laboratory practices of
(6) who has been working inside the biosafety level-3 suites in support of the CRP
Antigen Repository since 2005.3? These individuals consistently mentioned that (6)
would work with multiple strains of biological agents within the same biosafety cabinet at the
same time.342 This practice can lead to cross contamination. These statements were
corroborated when the 15?6 investigation team conducted video surveillance on 19 August 2015.
The surveillance video showed moving a large amount of plates containing biological
agents and dropping one of the plates on the floor outside the biosafety cabinet (See Figure 22).
lt also showed placing laboratory consumables on the front grille of the biosafety
cabinet which can affect the air?ow of the cabinet and lead to cross contamination (See Figure
24). Finally, the discovery of Bacillus anthracis outside of primary containment during
environmental sampling that was conducted by the 15-6 investigation team on 19-20 August
2015 (See Section LG) raises additional questions about the role that contamination may have
played in the inadvertent shipment at the center of this investigation as well as the other ?hot
lots? that have since been identi?ed.343

 
     

To summarize, the discovery of Bacillus anthracis outside of primary containment, coupled
with statements and video footage of (6) questionable lab practices prohibit elimination

 

34? See Tab 13-3, U.S. or ARMY, 702-! I, ARMY QUALITY PROGRAM (25 Feb. 2014).
3? See Tab 8-4.1 ., (6) DA Form 2823, Sworn Statement (20 Aug. 2015); Tab 
Resume; Tab B-27.1, page 1, (6) DA Form 2823, Sworn Statement (20 Au . 2015); Tab page
am, DA Form 2823, Sworn Statement, (27 Aug. 20:5); Tab 340.1, page Form
2823, Sworn Statement, (27 Aug. 2015).
3"2 See Tab 8-4.1, DA Form 2823, Sworn Statement, (20 Aug. 2015); Tab BELWP

.3, worn

[Em- DA Form 2 worn State ent 20 Au . 2015); Tab 3-34.1Em- DA Form
Statement, (27 Aug. 2015); Tab DA Form 2823, Sworn Statement, (27 Aug. 2015).

3?3 See Tab 846.1, (6) DA Form 2823, Sworn Statement. (24 Aug. 2015).

71

344

 
 

of contamination as a potential root cause of the shipment of viable Bacillus anthracis spores.
This also provides evidence that contamination should not have been dismissed by (6)

Andersen as a potential root cause of the 2007 shi ment of viable Bacillus anthracis to Lawrence
Livermore National Laboratories. (6)
(6) and the (6) missed

multiple opportunities to recognize that contamination could be an issue in their laboratories and
failed to institute appropriate corrective actions.

vi. Failure to Execute an Environmental Sampling Program

Environmental sampling is a useful tool for management to establish whether personnel
working within laboratories are utilizing best practices. Environmental sampling can also help
determine if employees are provided a clean and safe laboratory to carry out their assigned
duties. The goal of an environmental sampling program is to establish a periodic time frame to
determine if any potential contamination of the laboratory environment occurred due to a spill or
release of a persistent agent Bacillus anthracis) outside of primary containment such  a
biosafety cabinet. If sampling is conducted and only normal environmental bacteria is detected,
it is likely that the laboratory is utilizing best practices.

In order to assess the DPG-LSD environmental sampling program, the 15-6 investigation
team looked at practices implemented at other Army laboratories working with Bacillus
anthracis. The US. Army Medical Research and Materiel Command Safety Program directs all
of its laboratories that conduct research on ?agents with environmental persistence? 
Bacillus anthracis) to implement an environmental sampling program.345 The USAMRIID has
deveIOped a written program in which they conduct a random sampling of laboratories
working with persistent biological agents, with reports provided through their safety
of?ce to the USAMRMC safety of?ce. In contrast, ECBC does not conduct environmental
sampling in any of their laboratories since they rarely work with persistent biological agents, and
when they do they thoroughly decontaminate the entire work area. Additionally, ECBC
conducts an area decontamination twice a year.346

The DPG-LSD has a policy in place for implementation of an environmental sampling
program that they failed to execute.347 There is evidence that environmental sampling was
conducted by DPG-LSD in the biosafety level?2 spaces from 2004-2008. Environmental
sampling was conducted by DPG-LSD personnel once in the biosafety level-3 suites in 2004 in

 

3? See Tab 3-4.1, (6) DA Form 2823, Sworn Statement. (20 Aug. 2015); Tab 3-211, (6)

DA Form 2823, Sworn Statement E20 Auoi. 2015); Tab B~34.l DA Form 2823, Sworn
Statement, (27 Aug. 2015); Tab 3-40. I DA Form 2823, Sworn Statement, (27 Aug. 2015).
345 See US. ARMY MEDICAL RESEARCH AND MATERIEL COMMAND, REG. 385-], Safety Program, Ch. (l3 May
2009)

3?6 See Tab Email (6) om, subject: ESL-3 lab monitoring (29 Sept. 2015).
3?7 See Tab 3-7.2, page (6) DA Form 23, Sworn Statement, (2 Sept 2015); Tab C-3, WDL-

GEN-045, revision 3, (13 Nov. 2014). WDL-GEN-045 was originally implemented in February 20l2, but (6)

states that the latest revision (Rev. 3) was signed in November of 2014 with the goal of implementing
an env1ronmental sampling program. DPG-LSD blames a lack of resources/personnel for not implementing the
program.

72

response to a construction issue. However, there is no evidence of any routine environmental
sampling being conducted in the biosafety level-3 suites since 2004. The DPG-LSD (6)
did conduct a one-time limited environmental sampling within room 506 (biosafety
level-3 laboratory) in July 2015. During this limited sampling, [laxa- conducted both
surface sampling inside the biosafety cabinets and air sampling 0 the room, but did
not sample common high-use surfaces such as the ?oor, countertops, door handles and chairs.
Due to the limited nature ofthe environmental sampling in July 2015, found no traces
of viable Bacillus anthracis and therefore no reports were submitted to the chain of command.3?18
The lack of routine environmental sampling was also a ?nding by the Review Committee
examgl?gng procedures for inactivation of Bacillus anthracis during their site visit to the DPG-
LSD.

  
 

The DPG-LSD did approve a policy for an environmental sampling program in February
2012 that was revised again in November 2014 but never implemented.350 During the interview
process, a number of DPG-LSD personnel expressed concerns about potential laboratory
contamination to the 156 investigation team.? Out of concern for personnel safety and to help
the 15-6 investigation team rule out contamination as a root cause of the events reported on 22
May 2015, the 15-6 investigating Of?cer ordered that environmental sampling for Bacillus
anthracis be conducted in rooms 203 and 506.352

Based on the Investigating Of?cer?s order, a member of the 15-6 investigation team was
tasked to conduct environmental sampling. He was provided appropriate clearances, briefed on
procedures, and trained in accordance with DPG-LSD standard operating procedures inside
biosafety level-3 laboratories prior to conducting the sampling. He utilized sterile swabs and
water for sample collections. All samples were streaked on soy agar plates prior to
incubation. Results were determined through culture morphology and con?rmed through
polymerase chain reaction assay. Twenty-nine samples were collected in room 203 and twenty-
five samples were collected in room 506 (see Figure 20 and Figure 21). Following polymerase
chain reaction analysis, ?ve samples tested positive for Bacillus anthracis Ames strain in room
506 (Figure 21). Additional samples tested positive for a non?select agent strain of Bacillus
anthracis in room 203. The discovery of contamination on the floors and surfaces within room
506 is indicative of poor laboratory practices that likely resulted ?rm a spill. The likely spill
could have been tracked across different areas within the laboratory and possibly across the
suite.?3 According to Department of the Army Pamphlet 385-69 and 42 Code of Federal
Regulations 73, any biological mishap involving biological select agents and toxins that occurs
Outside of primary containment a biosafety cabinet) in a biosafety level~3 laboratory must be

 

3?8 See Tab 7.2.e, Enclosure 5 (6) DA Form 2823, Sworn Statement, (2 Sept 2015)

3"9 See Tab D-Z, page 6, Review Committee Report, inadvertent Shipment of Live Bacillus anthracis Spores by
(July 13, 2015).

35? See Tab page 2, (6) DA Form 2823, Sworn Statement, (2 Sept 2015); Tab 
GEN-045, revision 3, (13 Nov. 2014).

35' See Tab BALM, DA Form 2323, Swom Statement, (18 Aug. 2015); Tab B-16.l, (6)

DA Form 2823, Sworn Statement, (24 Aug. 2015); Tab 8-27. 1, page 1, (6) DA Form 2823, Sworn
Statement (20 Aug. 2015); Tab 3-33. 1 page 9, mm, DA Form 2823, Sworn Statement, (18 Aug. 2015).
?52 See Tab B-16.1, (6) DA Form 2823, Sworn Statement (24 Aug. 2015).

353 See Tab B?l6.1, 6 DA Form 2823, Swom Statement (24 Aug. 2015).

73

immediately reported to the ?rst general of?cer in the chain ofcommand and the CDC Division
of Select Agents and Toxins.334 The 15-6 team found no evidence that the spills that caused the
contamination found during the sampling it conducted were reported or documented.

 

Biosafety Level-2 Lab 203 Layout



She-[Ref I Incubator 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shaker 
26: Fridge
I I 
ill Giana Fridge
5; Microscope 3 Bib!
1: Cabinet 2

ii suite 
1:
Qt) Bioeafety
a me 
34 0
Incubator

 

 

 

 

 

 

 

 

 

 

Figure 20: Layout of Lab 203 with Sample Locations

 

Biosafety Level-3 Lab 506 Layout

G) 
?9 
Personal 

Computer 1 
il?l 

 

 

 

 

 

 

 

 

HON. . 

 

 

 

 

 

 

as)
Bioeafelv?@ 
Cagt 2 Incubator Fridge Freezer

 

 

 

 

 

 

 

 

 

Figure 21: Layout of Lab 506 with Sample Locations. Circles Marked in RED Tested Positive
for Bacillus anthracis Ames strain

 

35? See Noti?cation ofTheft, Loss, or Release, 42 CPR. pt. 73.19; DA Pam 385-69, para. 3-1 1.

74

The discovery of Bacillus anthracis outside of primary containment within room 506

re resents a failure of the DPG-I.SD technical and oversi ht management (6)
 to both  their

environmental sampling policy356 and ensure that their personnel were appropriately trained and
following best practices. It is the responsibility of leadership to provide a clean and safe
laboratory environment for all personnel assigned to work in the designated laboratories. This
?nding is the result of poor laboratory practices of personnel working within room 506. This
creates additional hazards for personnel in room 506 but also has the potential to be transferred
to other laboratories within the biosafety level-3 suite through foot traf?c. The failure to
routinely execute an environmental sampling program is perhaps the most questionable decision
made by DPG-LSD leadership.

vii. Failure to Maintain a Viable Video Surveillance Program

Army laboratories registered to work with biological select agents and toxins are required by
regulation to use Closed Circuit Television cameras for surveillance and to identify potential
safety or security issues-7?57 These cameras allow management to observe personnel within their
working environment to determine if they are using safe laboratory practices. Prior to 22 May
20l5, had a program in place whereby and were supposed
to view the closed circuit camera footage once a week for at least 15 minutes. (6)
indicated that he complied with this duty as defined, but indicated that he rarely
had time to break away from his other duties to do so. Regardless, the 15-6 investigation team
found no evidence that any DPG-LSD personnel received counseling, training, or discipiinary
action as a result of closed circuit television camera viewings.359

Surveillance footage of work performed in the biosafety level-3 suites between 9 June 2015 
l8 August 2015 was reviewed by the l5-6 investigation team on 19 Au ust 20i5. Three
separate deviations from safe laboratory procedures by two individualsm

(6) were noted during this review.

 

355 See Tab C-3, WDL-GEN-O45, Revision 3, ln-House Environmental Monitoring and Sampling Procedure for
Bacillus anthracis, paragraphs I.5.a, 1.5.b and l.5.h.

355 See Tab B-2.l, pages 15-16, (6) DA Form 2823, Sw0rn Statement, (21 Aug. 2015); Tab 3-7.2,
page I, (6) DA Form 2823, Sworn Statement, (2 Sept. 2015); Tab C-3, WDL-GEN-045, revision 3,
(13 Nov. 2014).
357 See Tab E-2, AR l90-l 7, para. 5-18. I
358 See Tab B-27.2.f, Enclosure 5, A ointment Letter Roving Observation
359 See Tab 3-2.1 page Form 2323, Sworn Statement, (21 Aug. 2015); Tab B?27.2.a,
pages 5-6, DA Form 2823. Sworn Statement, (20 Aug. 2015).

75

 

Figure 22: (6) Observations 2 7 May 2015

Figure 22 is a series of frames from surveillance video recorded on 27 May 2015 showing
(6) working in a biosafety level-3 laboratory at DPG-LSD. In frame #1 (6)
attempts to place a tray of spread plates (petri dishes) into the biosafety cabinet from a 
incubator. One of the plates slips out of the tray and onto the ?oor (frame picks
the plate off the ?oor, inspects it brie?y, and places it in the biosafety cabinet so that she can
continue working with it (frames A few seconds later, touches her face under
her powered air purifying respirator mask (frame After dropping the plate, (6)
should have immediately reported the spill to the DPG-LSD safety of?ce. Further reporting to
the CDC Division of Select Agents and Toxins and the Of?ce of the Director of Army Safety
would depend on the extent of the spill and the biological agent contained within the plate.

Figure 23 shows (6) working in a biosafety level-3 laboratory at DPG-LSD on 14
June 2015. (6) is inspecting samples that are being processed in a shaker-incubator
machine without wearing the personal protective equipment (a powered air purifying respirator)
required when working with liquid cultures.36'

 

Eig- bypassing her protective equipment by touching her face is an indication that she is not concerned
about sa ety and the critical nature of the work she is doing. This is further evidence of her poor laboratory
practices.

See Tab C-7, Safety Guide for Working in High-Containment ESL-3, WDL-SAF-330, rev. 10 (28 Oct. 20l4)
[hereafter 

76

 





 

Figure 23: (6 Observations 14 June 2015

Figure 24 shows working in a biosafety level-3 laboratory on 8 July 2015. It can
be seen that there is a piece of laboratory equipment inside the biosafety cabinet she is working
in. This would normally not be ofconcem, but the piece ofequipment is hanging over the edge
of the biosafety cabinet grille, potentially obstructing the air?ow in the cabinet. Clear,
unobstructed air?ow is critical to the proper operation of the biosafety cabinet, in order to ensure
optimal personnel safety and product protection.

 

Figure 24: (6) Observation 8 July 2015

The l5-6 investigation team also observed that the camera angles available for room 506
provided suf?cient wide-angle coverage of the room overall, but did not allow for viewing of all

77

operational work within the laboratory, including inside the biosafety cabinets, as required by
AR 190?17, paragraph 5~l 8.a. 362 Management must be able to review activities and procedures
occurring inside the biosafety cabinets themselves because this is where the detailed work is
being performed and where sample contamination is most likely to occur. Due to the insufficient
camera angles in use in room 506, the 15-6 investigation team was unable to verify statements
made by members of the DPG-LSD staff that (6) employed poor lab practices inside the
biosafety cabinets.363

In summary, during video surveillance review on 19 August 2015 of the previous 90 days of
work in the biosafety level-3 suites, the 15-6 investigation team discovered multiple deviations
from laboratory procedures and that the camera angles currently employed do not provide

complete covera'e. DPG-LSD leadershi (5) and the
DPG-LSD (5) hould

have discovered the same things with diligent execution and maintenance of the video
surveillance program.

  
 

Failure to Properly Review and Approve Critical Reagents
Program Internal Policies and Procedures

The use of validated, standardized protocols is key to working with biological select agents
and toxins, particularly in a production environment that requires repeatable, controlled
processes. Established protocols protect the health and safety of individuals working with
biological select agents and toxins and ensure that the materials produced meet customer needs.
in order to ensure that protocols meet these requirements, it is critical that key staff including
biosafety, biosurety, occupational health and quality assurance review and approve the processes
contained in the protocols. The following key personnel either did not know of the existence of

internal CRP Antigen Re ositor olicies and rocedure or were made aware them a?er the
22 May 2015 discovery: 

(6)
_t Dm-
LSD. act that these individuals were unaware of CRP Antigen Repository policies and

procedures does not appear to be their fault, but rather results from the (6)
(5) failure to appropriately share its policies and procedures.

Additionally, the review process for approving internal CRP Antigen Repository policies and
procedures was less stringent than the review process for other inactivation policies
and procedures. For example, the DPG-LSD protocol for the inactivation of biological agents,
underwent eight revisions since it was originally approved in 2001. The

 

352 See Tab E-Z.

?63 See Tab page 1, (6) DA Form 2823, Swom Statement, (20 Aug. 2015); Tab serum
(6) DA Form 2823, Sworn Statement (20 Aug. 2015); Tab Form 2823, Sworn
Statement, (27 Aug. 2015); Tab B-40.l (6) DA Form 2823, Sworn Statement, (27 Aug. 2015).

3? See Tab 8-6.1.a, page 4,2823, Sworn Statement, (19 Aug. 2015); Tab page
DA Form 2823, Sworn Statement, (20 Aug. 20l5); Tab 8-15.1, page 2, (6)

DA Form 2823, Sworn Statement, (18 Aug. 2015).
See Tab 01, 

various versions were each reviewed 12-l8 individuals, to include the (6)
Elli?various Branch and Division Chiefs,

and the  and was approved by the Dugway Proving

(6) In contrast, the CRP Antigen Repository Work Instruction 007 (CRPAR-
for the production, inactivation and viability testing of Bacillus anthracis underwent
five revisions since 2008. The current version of approved in December 2014,
was only reviewed by three individuals. A comparison of the reviewing of?cials for the most
recent versions of and Version 2.0 is provided in Figure 25.
received a much more comprehensive review.

n?son of the Revie Of?cials for and 
Version 8 Reviewers Version 2.0 Reviewers

 

Figure 25: Comparison of the Reviewing Of?cials of WDL-BIO-147 and CRPAR- WI-007
(Inactivation Protocols)

Moreover, it is critical to ensure that no confusion exists with regards to and

rotocols used for ecific work efforts. Several leaders at DPG and DPG-LSDW

knew two inactivation protocols existed, but did not take

appropriate steps to review and resolve issues that arose because the two protocols governed the

same processes and procedures. A comparison of the different versions of WDL-BIO- [47 with

the corresponding version of CRPAR-WI-007 clearly shows that operating conditions found in

the CRP Antigen Repository were fundamentally different from those within the rest of 

LSD (See Figure 26). These differences further highlight the leadership?s failure to review and

resolve con?icts and confusion among internal policies and procedures within 

  
 

 

See Tab CRPAR Work Instructions.
79

 

 

 

 

   

 

 

 

 

 

 

 

 

 

nag Paramater Year Paramater WDL-BIO-IM 
2(01 Version 0 Not in Effect 2012 Version 5 2
kGy Not stated  kGy 40:236y Not stated
Broth 5% Broth 96  
Broth Time 48 Broth Time 2414 248 
Broth Temp 35-37% -- Broth Temp 
Plate Time - Plate Time 4838 348 
Plate Temp Plate Temp 
2006 Version 1 Not in Effect 2013 Version 6 2.1
kGy Not stated - - kGy 40+2 kGy Not stated
Broth as 5%  Broth Brit . 
Broth Time 48 Broth ?me 2434 348 
Broth Temp 35-37%; Broth Temp 30%: 
Plate Ti me 324 Plate Ti me 4838 348 
Plate Temp Plate Temp 
2008 Version 2 1 2014 Version 7 5
kGy Not stated Not stated kGy 40+2 kG Not stated
aroma aroma 
Broth Time 48 >48 Broth Time 2414 >48 
Broth Te mp 35. Broth Temp 
Plate Time 324 >48 Plate Time 4838 :48 
Plat?eTe mp 35.37%: 34?; Plate Temp 
2010 Version 3 1.1 2015 Version 8 No update
kGy kGy 40+2 kG Not stated
Broth .-   Broth 
Broth Time 48 348 Broth Time 2414 348 
Broth Temp 35.37% Broth Temp 343%:
Plate Time >24 248 Plate Time 4838 >48 
Plate Temp 35.37%: Plate Temp 35g?c
2011 Version 4 1.2
kGy 40+2 kGi Not stated
Broth 
Broth Time 2414 348 
Broth Temp 
Plate Time 4818 {-48 
Plate Temp 

Figure 26: Comparison of Key Differences among Different Versions of WDL-BI 0-1 47 and
CRPAR- Wl-007 (areas in which the two protocols were the same or different are highlighted

in green and yellow, respectively)

ix.

Failure to Integrate the Critical Reagents Program into the
DPG-LSD Team

Evidence indicates that CRP Antigen Repository personnel perpetuated a perception that
their activities were proprietary in nature and this resulted in the Antigen Repository being
perceived and treated as a distinct and separate entity within the DPG-LSD which caused: 
failure to thoroughly review and approve protocols that the CRP Antigen Repository used when
inactivating Bacillus anthracis and conducting viability testinog (2) failure to conduct qualityl
control/quality assurance reviews to ensure that the RP Antigen Repository was following their
own procedures; and (3) failure to ensure that appropriate laboratory practices were followed.
The ?proprietary? nature of the CRP Antigen Repository may have contributed to the inadvertent

shipment of Bacillus anthracis.

The overarching belief throughout Dugway Proving Ground is that the CRP Antigen

Repository is proprietary in nature,
to DPG-LSD and DPG leadership.

80

 

and does not have to fulli cooierate and irovide information

of the West Desert Test Center, is responsible for reviewing protocols and standard operating
procedures for all quality?related efforts and lntemational Standards Organization l7025

accreditation efforts across Dugway Proving Ground West Desert Test Center. (6) 1
indicated in her sworn statement that the preprietary nature of the CRP Antigen Repository
resulted in signi?cantly less oversight than received by other programs/efforts within DPG-
LSD.367 Speci?cally, (6) denied two
individuals who worked for (5) access
to the results of an audit and other RP Antigen Repository documents. (6) also
stated that told her that all she was allowed to provide to (6) was the
scope of work and the International Standards Organization certi?cates and specifically stated
that she could not provide (6) 1 with anything related to production standard
Operating procedures, protocols or work instructions).368

 
 
   

 

(6) stated that the CRP management of?ce at Fort Detrick directed her to not Share
protocols and procedures due to their con?dential nature;369 however this was taken com I letel
out of context as ex lained in the sworn statements from

  
 

 

 
  
   

  

    

as well as
who indicated that

Irect at CRP Antigen Repos1tory protocols, standard operating procedures, or
work instructions could not be shared with or reviewed by appropriate personnel at DPG-LSD.370
The confusion seems to have stemmed from a misinterpretation of the CRP Security
Classi?cation Guide, and a requirement to protect sensitive spore production protocols and other
intellectual property from being disseminated to external entities.?

Leadership at DPG and DPG-LSD knew that the CRP Antigen Repository considered certain

aspects of its operation proprietary and did not take action to remed the issue or veri that
proper oversight was being provided.

requested and was denied access to the CRP Antigen Repository International
Standards Organization 17025 accreditation records.372 After being denied, he failed to press
harder for access or to consider the broad technical implications associated with
compartmentalization. Additionally, (6) with direct
management responsibility for CRP Antigen Repository personnel, acknowledged the pseudo-

compartmentalized nature of CRP erations but failed to reco nize or act on the issues it caused
within the facility.373 ?Hand also a key
reviewing of?cial of both CRP and non-CRP work instructions at DPG-LSD, failed to ensure
that the CRP work instructions received the same level of review as other DPG-LSD work

 

367 See Tab Page 2, (5) DA Form 2823, Sworn Statement (19 Aug. 2015).
368 See Id. at 2-3.
36" See Tab Pae 4, (6) Addendum to DA Form 2823, Sworn Statement (19 Aug. 2015).
37? See Tab 1340.1, (6) DA Form 2823, Sworn Statement (1 Sept. 2015); Tab 13-36145?, DA
Form 2823, Sworn Statement (14 Sept. 2015); Tab 8-132, (6) DA Form 2823, Sworn Statement (1 1
Sept. 2015).
37' See Tab B-36.i, (6) DA Form 2323, Swom Statement (14 Sept. 2015)
372 See generally Tab 8-6.1, (6) DA Form 2823, Sworn Statement (19 Aug. 2015) and Tab 3-14. 1,

DA Form 2823, Swom Statement (17 Aug. 2015). (6) indicated during his interview that
he had requested the records and was denied. It took two years for the information to ?nally be shared.

?3 See ieneralli Tab B-2.1.a, (6) DA Form 2823, Sworn Statement (21 Aug. 2015) and Tab B-27.1,

DA Form 2823, Sworn Statement (19 Aug. 2015).
81

instructions, and failed to emphasize the importance of integrating the CRP Antigen Repository
processes and procedures with the rest of the division.

The cause of the ?proprietary? perception of the CRP Antigen Repository appears to have
been (6) misunderstanding of directives from the CRP team at Ft. Dctrick and a lack of
communication between the DPG-LSD leadership and the CRP Antigen Repository team. The
CRP Antigen Repository operated in a pseudo-compartmentalized manner within DPG-LSD and
as a result did not receive the scrutiny and review required for a group producing Biological
Select Agents and Toxins intended for worldwide shipment. Although bears partial
responsibility for this failure, and should have questioned the
pr0prietary nature of the CRP Antigen Repository, not accepted ?proprietary? as an excuse when
being denied access to certain aspects of the operation, and acted to more integrate the
CRP Antigen Repository personnel into DPG-LSD.

x. Failure to Ensure Biosafety Officer Qualification

Army safety regulations require that facilities conducting infectious agent and toxin research
and ali facilities that store select agents and toxins designate an individual as the biosafety
officer.374 Biosafety of?cers will be trained and qualified and meet the following qualifications:

1) Bachelor?s degree with background in science

2) One year of iaboratory experience at equivalent biological safety level

3) A 3, 4, or 5 day Department of the Army approved biosafety course

4) DOD biosafety course

5) Army on-line training in safety policy and standards and risk management375

Biosafety of?cers serve as a facility/activity?s biological safety subject matter expert. They
support the risk management process by conducting risk assessments, de?ning biological safety
controls, managing the biological safety program, and assisting in development of standard
operating procedures. They also provide and/or support biological safety training, inspections,
emergency planning and reSponse, and mishap Biological
safety officers should be formally trained and understand the microbiology necessary to isolate,
manipulate, and propagate pathogenic microorganisms. The biological safety officer must be
able to apply practices and procedures to prevent occupational infections in the workplace or
release of the organisms to the environment or public.377 The Department of the Army
Biological Safety and Health Council determined that the biological safety officer position is
critical to biological operations. The biological safety of?cer position was made mandatory and
promulgated into Army reguiations in May of 2009.378

 

37? See DA PAM 385~69, para. 33. See also Part 331, Title 7, Code of Federal Regulations, 9 Code of Federal
Regulations Part l21, and 42 Code of Federal Regulations Part 73.

375 DA PAM 385-69, para. 3-8.

37? See DA PAM 385-69, para. 3-3.

377 See American Biological Safety Association, (last visited Sept. 16, 2015).

378 See DA PAM 385-69, para. 3-3; AR 385-10, ch. 20 requires mandatory implementation of DA PAM 385-69.

82

The DPG-LSD leadership had the responsibility to desi nate a uali?ed biolo ical safet
andfanedtodo (bus) designatedw

(5) because he did not meet the minimum requirements to be a biosafety of?cer.379 The
(5) position is unique to DPG-LSD and deviates from the biological

safety of?cer requirement mandated Arm re ulations. (5) assumed the
responsibilities as an Min 2012,380 and in this capacity signed
standard operating procedures and death certi?cates, duties above and beirond those of an

?38' was not fully quali?ed

(5)
because he did not meet the ducati uirement iosafety of?cer. (5)
and ultimately the (5)
(6) should have appointed a person that met Department of the Army

quali?cations or formally asked for a waiver or exception to the policy.

xi. Failure to Notify the Chain of Command of Biological Mishaps

Biological mishap reporting is a key component of the Army safety program for the purpose
of accident prevention and protecting human resources and the environment. The Army requires
all biological mishaps382 reported to the CDC or Animal and Plant Health inspection Service be
concurrently reported to the ?rst General Officer in the chain of command.383 Additionally, it is
incumbent upon laboratory staff to report mishaps and errors to their supervisors to ensure that
corrective action is taken. As discussed in Section l.F (Historical Mishaps at Life Sciences
Division Dugway Proving Ground), noti?cation through the chain of command for mishaps
reportable to the CDC was handled appropriately. But, for the various shipping errors that were

not reportable to the CDC, appropriate noti?cation to the chain of command did not occur.

As shown in Figure 9, was aware of the 2010 Venezuelan Equine Encephalitis
shipping error but failed to notify Both (6) and (6) were aware
of the 2010 Burkholderia mallet and the 2014 Vaccim?a shipping errors but failed to notify (6)

(6) (6) was aware of the 2014 Yersinia pestis shipping error but failed to notify
anyone in her supervisory chain.

 

one of her duties in her sworn statement (Tab 3-7. I but the
ma? signature On several documents Critical to this investigation revs. 5-8 and several
death certi icates, includin the one for Lot AGD0001667) were signed hym-

38" See Tab 8-14.] m?Enclosure to DA Form 2823, Swom Statement (2 Sept. 2015).

33' See Tab C49, Death Certi?cate for Lot i 8 Mar. 2014).

382 DA PAM 385-69, para. 3-1 1, de?nes a biological mishap as ?an event in which the failure of laboratory facilities,
equipment, or procedures appropriate to the level of potential pathogenicity or toxicity of a given etiologic agent
may allow the unintentional, potential exposure of humans or the laboratory environment to that agent." I

333 DA PAM 38569, para. 3~1 1, requires the completed Form 3 be submitted to the CDC or Animal and Plant Health
Inspection Service within seven calendar days, with a copy forwarded to the ?rst general of?cer in the chain of
command.

83

xii. Failure to Safeguard Classified Information and Ensure
Personnel are Trained on Classification Guidance

In June 2015, sent all Bacillus anthracis shipping records to the CRP of?ce at Fort
Detrick, Maryland for review by a task force that the Joint Program Executive Of?ce for
Chemical and Biological Defense established - Task orcc Anthrax.384 Task Force Anthrax was
directed to determine which laboratories received inactivated Bacillus anthracis based on the 22
May 2015 discovery. During the review Task Force Anthrax discovered that DPG-LSD
provided records containing classi?ed information. DPG-LSD sent their records through
unclassi?ed means. The improper transfer of classi?ed material is a violation of Army
Regulation 380-5, Department of the Army information Security Program.385

After the classi?ed information was discovered, the Joint Program Of?ce for Chemical and
Biological Defense conducted an assessment and found a number of shipping records that
contained classi?ed information.386 The assessment found no compromise to classi?ed
information, no damage to national security, and that the transfer was unknowing, but in
violation of the CRP Security Classi?cation Guide.387

Subsequent to the assessment, the Counterintelligence Of?ce at DPG investigated this
incident and found that CRP personnel at DPG were unaware of classi?ed shipping records, and
CRP personnel (excluding) were unaware of the CRP Security Classi?cation
Guide.388 Additionally, the investigation found provided no security classi?cation

trainin to ersonnel who were involved with the CRP. The investigation further found
_and

(6) were ?not aware of the CRP Security Classi?cation Guide, even though, in
(6) . case, she had been working at the CRP Antigen Repository for approximately [0
years.? As with the Joint Program Executive Of?ce for Chemical and Biological Defense
assessment, the DPG investigation found no compromise to classi?ed information, and that this
incident was not deliberate?? The investigation recommended ?provide training to
all Life Sciences Test Facility personnel concerning the classi?cation issues related to the

       
 

 

38? See note 12.

335 US. OF ARMY, REG. 380-5, DEPARTMENT OF THE ARMY SECURITY PROGRAM (29 Sept.
2000). This regulation establishes the policy for classi?cation, transportation, and safe-guarding of information
requiring protection in the interests of national security.

3? See Tab C-16, Memorandum for Record, subject: incident RepOrt Possible compromise of Classi?ed
Information l6 Jun 2015).

See Tab 016, Memorandum for Record, subject: Incident Report Possible compromise of Classi?ed
Information (l6 Jun 20] Tab 018, JOINT PROGRAM EXECUTIVE OFFICE FOR CHEMICAL AND BIOLOGICAL
DEFENSE, CRITICAL REAGENTS PROGRAM (CRP) CLASSIFICATION GUIDE (Nov. 2005).

338 See Tab C-i7, Memorandum for Record, subject: Inquiry of Violations of the Critical Reagent Program (CRP)
Security Classi?cation Guide (SCG) (18 June 20l5).

389 

39? Tab C- 7, Memorandum for Record, subject: Inquiry of Violations of the Critical Reagent Program (CRP)
Security Classi?cation Guide (SCG), para. 4 (18 June 2015).

39? See Tab C-l7, Memorandum for Record, subject: Inquiry of Violations of the Critical Reagent Program (CRP)
Security Classi?cation Guide (SCG) (18 June 20l5).

84

 and that ?ail new personnel assigned should receive the training within 30 days of
assignment at the Life Sciences Test Facility.?393

(5) failed to properly train DPG-

LSD personnel on the requirements of the Critical Reagents Program Security Classi?cation
Guide. No disciplinary actions were taken against (6) or other DPG-LSD personnel as a
result of the investigation conducted by DPG.

Summary of Failures to Take Action

Since 2007, DPG leadership and DPG-LSD management repeatedly displayed a tendency to
question the validity ofsubstantiated claims against DPG-LSD and downplayed the seriousness
of incidents and mishaps occurring within the Life Sciences Test Facility. The leadership at
DPG did not comprehensively investigate these mishaps, address incidents as
training/educational opportunities, or take disciplinary action against personnel. The DPG-LSD
failed to adhere to production based practices, failed to maintain and execute environmental
sampling and video surveillance programs, and in general, failed to enact proactive management
policies designed to continuously improve processes and prevent future mishaps.

When viewed holistically, these failures to act indicate complacency within the organization
and personnel not committed to continuous process improvement and employee development.
This complacent environment developed even after the repeatedly levied heavy civil
penalties against DPG, but later declined to enforce them based on status as a government
entity. Despite numerous ?ndings, DPG leadership and DPG-LSD management failed to hold
personnel accountable for their mistakes. This level of complacency and failure to act cannot be
tolerated in a zero-defect environment where the health and safety of employees and the public
are involved. The failure to look internally at each incident or mishap, and make every effort to
improve the organization directly contributed to the current environment of complacency, and
may have indirectly contributed to repeated biological mishaps, including the mishap that is the
focus of this investigation.

c. Complacency

The culture of complacency at DPG-LSD has existed since at least 2008.394 This culture is
documented in various reports. For example, Brigadier General Les Smith conducted a 15-6
Investigation in 20] and found a relaxed attitude toward accountability and security as a
contributing factor to the temporary loss of a vial of chemical agent regulated by the Army

 

?92 Tab C- 7, Memorandum for Record, subject: Inquiry of Violations of the Critical Reagent Program (CRP)
Security Classi?cation Guide (SCG) para. 7 (18 June 2015).

?93 Tab (3-17, Memorandum for Record, subject: Inquiry of Violations of the Critical Reagent Program (CRP)
Security Classi?cation Guide (SCG) para. 8 (IS June 2015).

The l5-6 investigation team has identi?ed the LLNL incident as the ?rst indication that complacency may have
been an issue at The notifications from the CDC in 2008 represent the ?rst missed opportunity to
scrutinize processes and procedures and in turn to potentially discover that complacency was a problem.

85

Surety Program resulting in a post shutdown.395 Also, as discussed in Section lI.B.3.b, a holistic
review of the Department of the Army Inspector General Biosurety lnspection Reports show a
trend of minor de?ciencies attributed to inattention to detail and complacency.

The culture of complacency was also noted in the statements and testimony of various
individuals who led or worked with DPG-LSD over the years. Below are multiple examples
where complacency was noted as an issue by individuals.

The current ATEC Commander Major General Daniel Karbler stated:

I believe that over-con?dence in abilities (as the Life Science subject matter
experts are a very select group) led to complacent practices. I likened it to the
failure of the Air Force ?3 nuclear force who allowed the nuclear cruise missiles to
be loaded and ?own. Such a small, select group can become overcon?dent in

their expertise. which could lead to complacent behavior. 396


(6) reported that a
number of leaders at the West Desert Test Center were having struggles that created ?notable
performance issues.?397 (6) also noted that his assessment after his first 90 days in

command was that ?the personnel at DPG were very aware of their but there was no
appetite to openly identify weaknesses and therefore there was little being done to address those
weaknesses.?398

(6)
expressed frustration that DPG-LSD is reactive vice proactive, lacks depth of thought in how it
investigates and responds to mishaps, and in general does not have any personnel thinking
critically about biosafety. In addition, he shared an example of a communication with DPG-LSD
in which an employee stated ?we have always done it this way? in response to a question about
one of their procedures.399

(6) made multiple comments
which suggested a complacent environment at DPG-LSD. stated that ?two
generations of DPG scientists and technicians had grown to trust our sterility testing SOP and
fostered a false belief that it was foolproof.MOO Additionally,stated:

(specifically (5) is responsible for

overall oversight of the Division ?5 inactivation procedures and capabilities and it

 

395 See Tab C-46, pages 36-7, 42, Findings and Recommendations, 15-6 Report - Chemical Accountability at DPG
(4-28 Feb. 20] I). This investigation was conducted while Colonel William King was in command at DPG. While
this investigation focused on the Chemical Test Division, it is evidence that complacency was an issue at DPG.

39" Tab B-22.l, Daniel Karbler, Daniel, DA Form 2823, Sworn Statement (25 Aug. 2015).

397 Tab Page 1, (6) Addendum to DA Form 2823, Sworn Statement (10 Sept. 2015).
Tab B-l page 5, (6) Addendum to DA Form 2823, Sworn Statement 10 Sept. 2015).
39" See Tab 6 Memorandum for Record, subject: Summarized Testimony of (6)

12 Nov. 2015).
Ta B-27.l.a, Page 5, (6) Addendum to DA Form 2823, Sworn Statement l9 Aug. 2015).

86

is management that bares [sic] the responsibility for assuring that all personnel
are adequately trained and pro?cient in conducting the processes delineated in
WDL-BIO-I 5 7, WDL-GEN-036, and other associated safety 

Furthermore, (6) stated that:

Following the incident and the resulting internal reviews, it became obvious to me
that we had developed a false sense of security in our sterility testing procedure
and as this procedure was passed between generations of employees that we
never stopped to conduct a critical review or perform any type of failsafe
experimentation. 402

These statements on the part of(b) (6) clearly indicate that complacency has been an
issue, and that although he recognizes this now, he missed key opportunities to identify the
problems prior to the inadvertent shipment of viable Bacillus anthracis.

(6) admitted to complacency in his
own action. In his sworn statement, (6) admits that ?he should consider being a bit
more proactive in compliance and in addressing mistakes and violations.?403 He also states that
he needs to ?do a betterjob of integrating the efforts of the Microbiology Branch personnel with
the R81 (Compliance) Branch personnel.?404

In summary, working with biological select agents and toxins is critical work that requires
great attention to detail and has little margin for error. This ?eld is highly regulated with
emphasis placed on ensuring that Operations are conducted in a safe, secure, and reliable
manner.405 Throughout the 15-6 investigation it became abundantly clear that the overall
environment within DPG-LSD was one of complacency. This impression was corroborated by
personnel who have worked with DPG-LSD over the years. The various failures to act discussed
in Section ll.C.l .b result from the complacent atmosphere at DPG-LSD. This complacent
atmosphere resulted in an organization plagued by mistakes and unable to identify systemic
issues in the high-risk, zero-defects world of biological select agents and toxins.

2. Responsible Party Accountability Findings

A preponderance of evidence does not exist to de?nitively attribute culpability for the
inadvertent shipment of viable Bacillus anthracis to an individual or group of individuals.
However, evidence exists to support ?ndings that leaders, oversight personnel, and lab
technicians failed to exercise due care in the performance of their respective duties. Below is a
discussion of the ?ndings related to the leaders, oversight personnel, and the lab technicians who
should or should not be held accountable.

 

 
 
  
  
 

Tab 8-27. 1 Page 3,
Tab B-27.l.a, Page I.
Tab Page l8, 

Tab 3.2.1.3, Page 6
4?5 See Tab E-I, AR 50-1, para. 

DA Form 2823, Sworn Statement (l9 Aug. 2015).

Addendum to DA Form 2823. Sworn Statement (19 Aug. 2015).
Addendum to DA Form 2823, Sworn Statement Aug. 20l5).
Addendum to DA Form 2823, Sworn Statement (21 Aug. 20l5).

87

a. Senior Leaders at the Army Test and Evaluation Command Headquarters, the
Developmental Test Center, and Dugway Proving Ground

The l5-6 investigation team considered the level of management or command at which
accountability for the various mishaps, failures, and overall complacency at DPG should
ultimately rest. Figure 27 shows a pictorial view of senior leaders at West Desert Test Center.
DPG, the Developmental Test Center,406 and ATEC headquarters overlaid with key historical
events at DPG. The intent of the ?gure is to assist in determining which senior leaders were in
command and whether or not they knew about and acted reasonably in response to each incident.
This ?gure does not include data for the ?hot lots? shown in Figure l7. However. the seven
events addressed in Figure 27 were missed opportunities where key leaders at DPG could have
identi?ed the scienti?c and complacency problems present at DPG-LSD.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Dr. James Streilein  9 0 LLNL (Bacillus anthracis)

Mr. David Jimenez
Mr. Michael Etzinger I I vx (Chem) 15?6

 

 

 

 

. Botulinum neurotoxinA

 

Indicators

 

Figure 27: Analysis of Senior Leaders

The seven events addressed in Figure 27 were critical indicators and should have prompted
senior leaders to take action. Events l-3 in red are associated with the inadvertent shipment of
viable Bacillus anthracis to Lawrence Livermore National Laboratories in 2007. Event is the
noti?cation from Lawrence Livermore National Laboratories that it had found a viable spore in
April 2007; event 2 is the initial noti?cation to DPG-LSD that the DHHS-OIG may consider the
shipment to be an unauthorized transfer of select agent in March 2008, and event 3 is the ?nal
noti?cation to the DPG commander ?nding DPG-LSD to be at fault and authorizing civil
monetary penalties to be imposed in December 2009.407 Event 4 in amber encompasses the
investigation and deliverables associated with 80 Leslie Smith?s 15-6 report on Chemical
Accountability at DPG in early 201 1.408 Events 5-7 in blue are associated with the erroneous
shipments of Botulinum neurotoxin A. Event 5 is the original noti?cation from NMRC in April
20l 1; event 6 is failed Department of the Army lnspector General Biosurety Inspection in

 

?6 An intermediate one-star command that was merged with ATEC in 20] l.

See Section l.F. See also Tab C-4l. LLNL Correspondence and Evidence.

See Tab C-46. l5-6 Report. Chemical Accountability at DPG (4-28 Feb. 20l I). This investigation and report was
not focused on DPG-LSD. Given the severity of the incident and the ?ndings about complacency, the l5-6
investigation team believes it should have prompted DPG leadership to investigate other labs as well.

88

 

May 20l 1; event 7 is the ?nal noti?cation to ATEC headquarters ?nding DPG-LSD to be at fault
and authorizing civil monetary penalties to be imposed in November 20] 1.409

These historical events clearly correlate to the ?ndings of the 15-6 team during the current
investigation. Events 1?3 (LLNL) included failures in inactivation, viability testing, potential
contamination, and a failure to investigate and hold personnel accountable at DPG-LSD. The
15-6 investigation tied to event 4 found that a ?relaxed attitude? complacency) was an issue
in a laboratory conducting critical operations at DPG. Events 5-7 (Botulinum neurotoxin A)
included inadvertent shipments, document errors, and again failures to investigate and hold
personnel accountable for their actions. All of these failures had common attributes and were
Similar in nature to the inadvertent shipments of viable Bacillus anthracis prompting this
investigation.

1. 2008-2011

As bracketed in red in Figure 27, the critical historical indicators which should have triggered
command action occurred between 2008 and The evidence collected shows that the
indicators were readily apparent to the installation commanders at DPG. (6)
and Colonel William King were the Commanders at DPG during this timeframe.

(6)

(5)

received the 3] March 2008 memorandum (Event 2) from the DHHS-OIG indicating that DPG-
LSD violated select agent regulations in association with the LLNL event. The evidence
gathered by his staff and contained in his response on 28 April 2008 included information about
the questionable viability test results, speci?cally that the ?fth vial that was ?cloudy with
contamination?? Given that knew about this contamination, he had a duty to
direct a comprehensive investigation to resolve the inconsistent ?ndings between the DHHS-
and the staff. He also had a duty to determine why the vial was 
contaminated, and why the entire batch was not destroyed as per viability testing standard
operating procedures.?2 He failed in these duties.413 - failed to hold anyone
accountable for the mishap, and missed an opportunity to critically review the inactivation and

 

See Section LF See also Tab 042, Bot A Correspondence and Evidence.

"0 The shipment to LLNL occurred in 2007, but the scope and severity of the issue was not understood until 2008

when the CDC ?rst indicated that DPG-LSD may be found liable for having violated surety regulations.

See generally Tab C-41, LLNL Correspondence and Evidence.

?2 See note 95.

"3 The investigative team identi?ed an additional duty to report this event to his higher headquarters. The

evidence is inconclusive as to whether or notm- reported this event to his commanders at DTC or ATEC.
(5) ndicated that he reported it to BC (now MG retired) Turner; however 80 (now MG retired) Turner

had no recollection of this event. 36 (now MG retired) Turner agreed that this event should have been reported;

however through a passage of time evidence and memories have been lost. See Tab 

m, Memorandum for Record, subject: Summarized Testimony of MG (R) Del Turner Nov. 2015 See
Ta (6) -, Memorandum for Record, subject: Summarized Testimony of
(lg-(30 Oct. 2015).

89

viability testing processes utilized by DPG-LSD. Moreover, this is indicative that (6)
did not appreciate the scope and severity of the LLNL incident.414

 

 

(5)

  
  
 
  
 

Positions Held:

Position Description)
Duties: Findings/Failures:

Failed to conduct an internal investigation to

resolve the discrepant ?ndings of the 

Re3ponsible for a wide variety of 010 and the DPG-LSD staff with respect to the

laboratory, chamber, and ?eld testing of LLNL incident

 

 

Serve as the

chemical/biological (CB) defense Failed to determine why the entire batch of

systems, obscurants and illuminants, and Bacillus anthracis was not destroyed when one of
environmental characterization and ?ve vials was found to be contaminated
remediation technologies Failed to determine the root cause of the
Executes the OSD~directed CB Joint contaminated ?fth vial or to consider the role it
Test Program played in the shipment
ReSponsible for the discipline, morale, Failed to hold personnel accountable for the
health, and welfare for approximately LLNL incident

2500 military, civilians, contractors, and
their families

Responsible for the security/PP,
information assurance, environment,
safety, and community activities as the

Senior Commander
Figure 28: (6)

 

 

 

 

Colonel William King

 

Colonel William King commanded DPG from July 2009 to July 201]. He spent the ?rst few
months of his command away from DPG attending a pre-command course. He was present to
receive the 2 December 2009 memorandum (Event 3) from the ?nalizing the ?nding
that violated select agent regulations and authorizing a civil monetary penalty.
Colonel King insisted in sworn testimony that he directed a commander?s inquiryresponse to this noti?cation, but the evidence indicates that
he only requested a ?response and discussion? from (6) 4'5

 

4? The sta?c at DPG assumed that the LLNL event response was completed after the memorandum they provided to
the on I May 2008. As a result, [Em- did not speci?cally address this incident with Colonel
King during their battle handover. The 2 December 2009 memorandum to Colonel King was a surprise to DPG
leadership who assumed the case was closed.

?5 See Tab 04] pg. 81, LLNL Correspondence and Evidence; See also Tab Me 

subject: Transcribed Testimony Mm (12 Nov. 2015); See Tab Bedhm

Memorandum for Record, subject: Summarized Testimony of (6) (12 Nov. 2015). The testimOnics of
(6) an (6) are consistent and refute BO King?s testimony about the ?commander?s inquiry?.
(6) reca at (6) led the reSponse and discussion and that he had little direct input.

90

?response and discussion? reiterated the DPG-LSD conclusion from 2008
that LLNL was the source of contamination, but omitted information about the questionable
viability test results the contaminated fi?h tube). This omission is important, but
information about the contaminated ?fth tube was available to Colonel King had he reviewed the
past correspondence and documentation associated with the incident.?6 Colonel King had a duty
to direct a comprehensive investigation to resolve the inconsistent ?ndings between the 
report and the DPG-LSD staff explanation, particularly because as of December 2009, the
?ndings against DPG-LSD were ?nalized and a civil monetary penalty was authorized, clearly
establishing the scope and severity of the LLNL incident. Colonel King?s testimony that he
conducted a commander?s inquiry is uncorroborated by the evidence which shows that it was
merely a request for information from a single individual.

Colonel King received 80 Smith?s 15-6 investigation (event 4) warning of a ?relaxed
attitude? in a critical chemical laboratory at DPG. Colonel King, in conjunction with Major
General Dellarocco, took appropriate action after receiving the results of the 15-6 investigation.
He issued reprimands and removed personnel within the chemical test facility.4'7 However,
Colonel King did not assess the management personnel at DPG or consider that the negligence
described in the 20] 1 15-6 report of investigation could extend to other facilities on DPG. This
is in spite of the fact that he testified that he was aware that there was a problem with self-
policing across all of DPG, to include the Life Sciences Division.?8 Colonel King missed an
opportunity to assess the effectiveness of personnel and procedures at DPG as a whole.

Finally, Colonel King knew about the erroneous shipments of Botulinum neurotoxin A, and
that these shipments caused DPG-LSD to fail the 201 DAIG Biosurety Inspection (event 5 and
6). lnstead of considering all of these events as indicators of potential deep-rooted and
widespread problems at DPG, he attempted to minimize the impact of the events. Colonel King
sent an email to leaders at ATEC and DTC downplaying the seriousness of the shipping errors
(see Section This interpretation was refuted by CDC and personnel who
have maintained their stance that this issue was always considered serious.?9 Colonel King also
non-concurred with the failing de?ciency in the 201 DAIG Biosurety Inspection report,
incorrectly citing DOD and DOT regulations.420 These responses, when considered holistically,
show that Colonel King was unwilling to take a deeper look at the operations he commanded,
and ultimately perpetuated a complacent atmosphere.

Colonel King had personal knowledge of the all indicators described above. As a
Commander he had a duty to think strategically about how these indicators are related, to notice
that they had widespread implications across DPG, and to investigate and remedy problems

 

"6 Brigadier General King testified that he did not review past correspondence and documentation.
"7 See Tab 8?212, Memorandum for Record, subject: Transcribed Testimony of 30 William E. King, IV (10 Nov.
2015).

?8 See Tab pg. 3, William King, DA Form 2823, Sworn Statement (25 Se .2015 .
"9 See Tab B~67.l Memorandum for Record sub'ect: Summarized Testimony of?axah( 12 Nov.

2015); See Tab 869.1% Memorandum for Record, subject: Summarized Testimony of
(12 Nov. .

- ee a C-36, BSI 2011, para. 2-1.

91

accordingly. Colonel King failed in these duties. Colonel King responded to each incident by
correcting de?ciencies identi?ed by outside organizations, but he failed to conduct internal
reviews to improve the operations of DPG and prevent future incidents. This indicates a lack of
introspection and leadership expected from senior personnel. It should also be noted that during
his command, Colonel King repeatedly de?ected blame and minimized the severity of incidents.

l-Iis tendency to de?ect and minimize was re?ected in his email correSpondence

42' and also in

his interactions with the 15?6 investigating officer.422 During the course of the investigation it
was apparent that even now, Brigadier General King lacks introspection and fails to recognize
the scepe and severity of the incidents that occurred during his command at DPG.

 

COL (now BG) William E. King, IV

 

Position Description)

Positions Held: DPG Commander (July 2009 to July 201 - See Tab DPG Commander

 

Duties:

Findings/Failu res:

 

Serve as the Installation Commander at
Dugway Proving Ground

Responsible for a wide variety of
laboratory, chamber, and ?eld testing of
chemical/biological (CB) defense
systems, obscurants and illuminants, and
environmental characterization and
remediation technologies

Executes the OSD-directed CB Joint
Test Program

Responsible for the discipline, morale,
health, and welfare for approximately
2500 military, civilians, contractors, and
their families

Responsible for the security/PP,
information assurance, environment,
safety, and community activities as the
Senior Commander

 

 

Failed to take reasonable command action and
review historical documents and correspondence
related to the LLNL incident

Failed to conduct an internal investigation to
resolve the discrepant ?ndings of the 
OIG and the DPG-LSD staff with respect to the
LLNL incident

Failed to make a holistic assessment ofthe
management personnel at DPG or to consider that
the negligence described in the 201 1 15-6 report
could extend to other facilities on DPG

Minimized the ?ndings
regarding the erroneous Botulinum neurotoxin A
shipments

Faiied to think strategically about how the
indicators that occurred during his command are
related, to notice that they had widespread
implications across DPG, and to investigate and
remedy them accordingly

Failed to hold personnel accountable for mishaps

 

Figure 29: COL (now BG) William E. King, IV Summary

 

42' See Tab 042, pg. 12, Bot A Correspondence and Evidence
?2 See Tab Memorandum for Record, subject: Transcribed Testimony of B0 William E. King, IV (10 Nov.
2015); Tab B-23.1, pg. 3, William King, Daniel, DA Form 2823, Sworn Statement (25 Sep. 2015).

92

 

Maior General (R) Genaro Dellaracco

Major General (R) Genaro Dellarocco commanded ATEC from October 2010 to July 2013.
He received the results of Brigadier General Smith?s 15-6 investigation (event 4) and was in
command during the entirety of the correspondence and response to the erroneous shipments of
Botulinum neurotoxin A (events 5-7). Major General Dellarocco worked with Colonel King to
take appropriate action in response to Brigadier General Smith?s 15-6 investigation by issuing
reprimands and removing personnel within the chemical test facility.423 After receiving the ?nal
noti?cation from the DHHS-OIG that DPG-LSD violated select agent regulations with the
erroneous Botulinum neurotoxin A shipments, Major General Dellarocco implemented a
Commander?s Critical Information Report and personally tracked the next three shipments of
select agent from DPG-LSD to ensure the effectiveness of the corrective actions and to
emphasize that this was a command priority.424 Major General Dellarocco candidly stated that
in hindsight, with all of the facts he knows today, he should have picked up on the complacency
issues at Thus, he demonstrated the introspection expected of an effective leader by
critically assessing his leadership in light of new information presented to him during
the investigation. The evidence indicates that Major General (R) Dellarocco acted reasonably in
response to the indicators available to him at the time.

(5)

 

 
   

The Lawrence Livermore National Laboratories events 2 and 3 occurred during his

command, but as the (6) he did not have responsibility

for responding to the event. (6) 26


corresponded directly with the CDC, and the and Colonel
Kin had ultimate res onsibility for taking action in response to the incident. In his testimony,

?Hmcalls being aware of the LLNL incident, and being indirectly
involved in a support role, but evidence does not exist to allow the 15-6 investigation team to

assess the reasonableness of (6) actions given his role at DPG at the
time.

Other Senior Leaders at ATEC DTC and DPG

 

During the 2008-201 1 time??ame, there was signi?cant turnover and realignment of senior
leadership positions at ATEC, DTC, and DPG. The West Desert Test Center command
billet was eliminated in July 2010. Base Realignment and Closure resulted in the merging of
DTC427 with ATEC in June 201]. The command position was transitioned from military to

 

423 

?4 See Tab C-42, pg. Bot A Correspondence and Evidence. MG Dellarocco required that he was personally
noti?ed, via CCIR, of the next three shipments of biological material from DPG-LSD and also that the material was
veri?ed upon receipt.

?25 See Tab Memorandum for Record, subject: Transcribed Testimony of MG Genaro Dellarocco (27 Oct.
2015)

42" See Tab C-4l, pg. 7, LLNL Correspondence and Evidence. (6) received the 2 May 2007 memorandum
from the CDC.

??27 The merger also resulted in the elimination of the 0-7 DTC command billet.

93

civilian in preparation for this three years earlier when Mr. James Johnson took command from
Brigadier General Frank Del Turner. Mr. Johnson served nearly a full-term as Executive
Director of DTC from July 2008 to May 2010, but was followed by two temporarily assigned
Executive Directors in Mr. Mike Etzinger and Mr. David Jimenez prior to execution of the
merger in 201 1. Furthermore, the 0-8 ATEC command billet, occupied by Major General Roger
Nadeau from June 2007 to March 2010, was temporarily ?lled by a civilian Executive Director,
Dr. James Streilein, between March and October 2010.

There is no evidence indicating that these personnel acted unreasonably or unprofessionally
while in command. The evidence indicates that from the ATEC and DTC perspective, the
incidents described above were being adequately addressed at the DPG command level.
Generally, the leaders at the ATEC and DTC command level did not possess any information
that would cause them to question the actions of the DPG Commanders. Furthermore, the
evidence shows that the signi?cant turnover and realignment within the ATEC and DTC
organizations during this time period made communications through the chain of command
dif?cult. As a result, it is reasonable that ATEC and DTC leadership would not have been able
to assess the indicators of complacency as effectively as the commanders at the DPG level
during this time frame.428

2. 2007 and Prior

It can be seen in Figure 27 that Major General (retired) Robert Armbruster, Brigadier
General retired Marvin Keith McNamara, Brigadier General (retired) Michael Combest and
Mrelinquished command well before the ?rst event occurred. There
is no evidence indicating that these personnel acted unreasonably or unprofessionally while in

command. The shipment of viable Bacillus anthracis to Lawrence Livermore National

Laboratories in April 2007 (event 1  occurred vei near the end of the commands of Ma'lor
General (retired) James Myles,

(5) and at this point in time there were no conclusive ?ndings to indicate a
signi?cant problem at DPG-LSD. There is no evidence indicating that these personnel acted
unreasonably or unprofessionaily while in command.

3. 2011 to May 2015

Major General Peter Utley

Major General Peter Utley commanded ATEC from July 2013 to June 2015. None of the
incidents or indicators discussed above occurred during his command, nor was he briefed on
them during his battle handover from Major General Dellarocco. Although Major General

 

?23 See Tab 13?47. I (6) Memorandum for Record, subject: Summarized Testimony of
James Nadeau (26 Oct. 2015); Tab 8-52. 1 Ham?Memorandum for Record, subject:
Summarized Testimony of James Streilein (28 Oct. 2015)Tab Memorandum for
Record, subject: Summarized Testimony ofMike Etzinger (4 Nov. 2015)Tab 8-511, (6)

Memorandum for Record, subject: Summarized Testimony of James Johnson (4 Nov. 2015); Tab 6
(6) Memorandum for Record, subject: Summarized Testimony Del Turner (4 Nov.
2015 

94

Utley?s commanded ATEC at the time of the discovery of the inadvertent shipments of viable
Bacillus anthracis, there were no indicators that he knew or should have known of this issue
prior to its discovery in May 2015. Additionally, he was prepared to investigate the inadvertent
shipments of viable Bacillus anthracis; however, the Director of the Army Staff decided that an
investigator from outside ATEC was appropriate.429 Based upon the facts discovered during this
investigation, it appears Major General Utley complied with his duties and responsibilities.

(6)



received the notification from the DHHS-OIG determining that DPG-LSD violated select a ent
regulations with the erroneous shipments of Botulinum neurotoxin A (event 7). 
worked with Major General Dellarocco to execute the Commander?s Critical Information Report
which tracked the next three shipments of select agent from DPG-LSD to ensure that the
corrective actions were effective and to emphasize that this was a command priority. The
evidence indicates that there were no further indicators that should have triggered (5)

to take action, and it appears that he complied with his duties and 

(6)

(5) . Although he was in

command of DPG at the time of the discovery of the inadvertent shipments of viable Bacillus
anthracis, he was not present for any of the indicators described above. (6) identi?ed
issues with complacency and leadership at DPG during his ?rst 90 days in command after
conducting a thorough review of command climate surveys, 15-6 investigations, commander?s
inquiries, and external inspections. In reference to the findings of the various issues he reviewed,
(6) stated that ?many of the ?ndings indicated that those events [various prior
mishaps] could have been prevented or the impact reduced if the Division and Branch Chiefs had
exercised better leadership and supervision.?431 Based on this discovery, placed
an emphasis on leader development in order to devcl0p effective supervisors. He ?thher
assessed that DPG ?seemed to struggle to meet required timelines during the first year of my
command.?32

  

    

In addition, (6) had evidence that (6) was hindering efforts to develop the
Division Chiefs. (6) stated that (6) would not suppon performance
evaluations below a ?tOp block?433 even for those leaders whose performance did notjustify this
rating. This indicates that (6) who was serving in a critical technical management role
at DPG, perpetuated the culture of complacency at DPG. Based on these observations, among
others, (6) removed from the rating chain and replaced him with

 

?29 See Tab B-4l.l, Peter Utle DA Form 2823, Sworn Statement (01 Sept. 2015).

43? See Tab B?45.l, Memorandum for Record, subject: Summarized Testimony of (6)
26 Oct. 2015)

Tab 3-1 1.2.3, Pa 8, Addendum to DA Form 2823, Sworn Statement 10 Se t. 20i5 .

Id. (6) 

?33 Tab B-l 1.2., DA Form 2823, Swom Statement (10 Sept. 20I5).

95

  

(6) 434 Alter the change, (6) noted that held the Division Chiefs more
accountable. Additionally, ?received more direct feedback about those areas
where individuals were not performing well.?35 ability to meet mission
requirements appeared to improve during (6) second year in command. He
attributed this improvement to removing the rating chain and replacing him
with (6) 43" Based upon the facts discovered during this investigation, it appears (6)

(6) identi?ed complacency as an issue at DPG, took action to remedy it, and otherwise
complied with his duties and responsibilities.

4. May 2015 to Present

Major General Daniel Karbler is the current ATEC Commander. (6)
the curren Since assuming command, these personnel facilitated a litany of
inspections and investigations at DPG-LSD. They effectively assisted the inspectors and
investigators in gathering evidence and ensured that personnel at DPG receive the necessary
resources and counseling needed to help them cope with the stress of these investigations.?m
The evidence indicates that Major General Karbler and (6) are effectively
executing their duties and responsibilities.

b. West Desert Test Center Civilian Leadership
(6)

had a duty to provide
oversight to DPG-LSD. (6) is responsible for the management and operation of the West
Desert Test Center which includes eight divisions; one of which is the Life Sciences Division. A
thorough review of the evidence shows (6) recognized issues with the command climate,
complacency, and a lack of personal accountability and attempted to address these problems
through a variety of strategic initiatives.438 The evidence shows that has displayed
leadership skills and has made significant efforts to address and improve the work environment
at DPG.439 Additionally, a?er being appointed to his current position, has been
observed to hold the various DPG Division Chiefs more accountable for their actions than did his
predecessor, and was directly credited with assisting in improving operations at DPG-LSD by

40 There is no evidence that he failed in any of his leadership or oversight
duties from November 2012 to present and/or contributed to the complacent environment at
DPG-LSD.

 

43? See Id. at 3.

?35 Tab 2., page 3, m, DA Form 2823, Sworn Statement (10 Sept. 20l5).

?35 Ia?. (6) attributed part 0 the performance improvement to the ?hard w0rk by the employees to meet
customer test requirements and also prepare for and successfully complete the numerous inspections.?

?37 See generally. Tab Form 2823, Sworn Statement (17 Aug. 2015).

See Tab 8-182, (6) DA Form 2823, Sworn Statement (20 Aug. 20] 5).

4 Id.

?40 Tab 1.2., page 3,  DA Form 2823, Sworn Statement (IO Sept. 2015).

96

   

failed to recognize and take action to address complacency at DPG-LSD.
(6) . having remained in key leadership positions at DPG as the military leadership
rotated in and out. had perspective based on continuity that other senior leaders could not have
had. He knew or should have known that DPG-LSD had a number of mishaps that were not
addressed internally. (6) should have taken af?rmative steps to educate. train. and look
into each mishap (or advise the DPG commander to do so) to determine if internal policies and
procedru'es should change. The evidence does not show that (6) was proactive in
addressing these failures and as such he facilitated the complacent environment at DPG-LSD.

b_ (5) . had a duty to
hold individuals and Division Chiefs responsible for their actions. recognized 

(6) failure in leadershi? and failure to hold employees accorurtable for mistakes.442

    

 

 

  

 
  
 

(6) observed that did not support ratings below a top block for those that
on not per ornr. and that his cormse mg and performance evaluations hindered efforts to develop
Division hiefs.443 In addition. failed to initiate or advise the cormnand to initiate a
inquiry or a 15-6 investigation in response to the Botulinum neru?otoxin A shi ing
errors despite the CDC ?3 rendering of $1.500.000 worth of ?nes.444 As a result of?
failed leadership. in 2012. Colonel Fizer removed Dr. Gritton from the rating chain of Division
Chiefs. and assigned the responsibility to (6) .445

  
  

   
 
 

c. (6) from 2011 to the
had a duty to question the ?proprietary? and isolated natru?e of the RP. which resulted
in pseudo-compartmentalized446 operations at DPG-LSD. had a duty to wane that
all standard operating pr'ocedru?es and work instructions receive approval in conrpliarrce with
standard DPG-LSD staf?ng procedures and other regulatory requirementsoversight role that required him to be part of the review and
approval process for all of the standard operating procedru'es used at DPG-LSD. (6)

  
  
 
   
  
  
 

 
 

was

 

See Appendix A.

  

- See Ta B-l 1.1. page 2. . DA Form 2823. Sworn Statement 13 Aug. 2015 1 Tab B-l 1.2. page 3.

m. DA Form 2823. Sworn Statement (10 Sept. 2015).

See Ta B-11.2. page 3. (6) . DA Form 2823. Sworn Statement (10 Sept. 2015).

See Tab B-14.2. (6) . Memorandum for Record. subject: of

(15 Dec. 2015 . Note rat re maximum civil penalty authorized for this violation 1s
500.000. ut snrce there were three separate 81500000 in penalties could have been levied.

?5 Id. was not formally demoted nor did he receive disciplinary action. only the rating chain was

re .

446 This term is used by the 15-6 investigation to characterize the relatively isolated nature of the CRP Antigen

Repository within DPG-LSD. The RP team at DPG-LSD in many ways acted as if they were an entirely separate

entity from the rest of DPG-LSD when in fact the conrpartnrentalizatiorr was derived from the misinterpretation of

guidance they received about intellectual property and secru?ity classi?cation.

 

97

aware of the alleged ?proprietary? nature of the RP work instructions and International
Standards Organization certi?cation documentation for years and even requested co ies.
However, after being denied access to the documents, he did not ?uther question
or the RP leadership at 011 Detrick about the natru?e of this alleged limitation. Because
failed to take any action beyond requesting these documents. there was no oversight or

proper approval of documents governing RP operations at DPG-LSD. (6) knew or
should have known of these duties. but failed to execute them.

    
    

 

 

(5)

   
 
 

Positions Held:

 

   

 

 

   
 
 

 

 

 

 

Findings/Failures:
Serve as the Failed to conduct internal investigations at DPG-LSD
Failed to take appropriate disciplinary action in response to
mishaps
Support in management of Failed to hold personnel accorurtable for lack of performance
2200 personnel and 120 active Failed to recognize and rernediate complacency at DPG-LSD
test programs Failed to question the proprietary natrn'e of the RP
Responsible for technical Failed to maintain technical control/oversight over the RP
control, coordination. and Antigen Repository
management of DPG's test Failed to review RP SOPs in accordance with process used
programs for other DPG SOPs
Figure 30: (6) Summary
c. DPG-LSD Leadership
(5)
(6) ?as the (5)

 
 
   
 

ra owrng utres ut ar to executet em:

a. (6) had a duty to hold personnel accountable for mistakes and de?ciencies.
(6) knew or should have known that he had this duty and negligently failed to execute it.
On two occasions 2009-2010 LLNL incident response and the 2011 Botulinurn neurotoxin A
response).w failed to take any corrective action against employees despite the
seriousness of the associated incidents. These incidents could have resulted in over $2,000,000
of CDC ?nes. (6) placed blame for the incidents on external organizations rather than
conducting internal inquiries or advising the cormnand to conduct 15-6 investigations to address
de?ciencies and improve the performance of DPG-LSD.448

 
 

 

?7 See Tab B-14.l. (6) . DA Form 2823. Sworn Statement (17 Aug. 2015): Tab B-14.3. (6)
Biography.
See Section Failure to Take Action. where it describes leadership?s repeated failru?e to investigate
mishaps and take appropriate disciplinary action.

98

b. had a duty to manage, supervise, and lead personnel and to prevent
complacency at DPG-LSD. He knew or should have known that he had these duties, but
negligently failed to execute them. His leadership created and fostered a culture of limited
supervision, a lack of oversight, and widespread complacency. For example:

i. Witnesses describe w- as being passive, isolated, in his of?ce, not a
people person, and not proactive.

ii. Witnesses stated the transition of leadership from (6) to (6) resulted
in a decrease in workplace morale.?O

freely admits that need to spend more time getting around the
Division and stepping into the weeds with Division personnel. My concern is that I am not
familiar enough about the details of what is going on in the lab. This is not due to lack of
interest, but is simply a re?ection of lack of time, and perhaps needing to be more organized.?45'

iv. described the command climate at DPG-LSD as ?generally average to
frustrated and somewhat many personnel attributed that to the fact that they did not
feel that (6) cared or was engaged.?452 These leadership deficiencies prompted
to increase the emphasis on leadership skills as part of the performance objectives
for all ofthe Division Chiefs at oped?

 
    

 

c. knew or should have known that he had a duty to provide Colonel King with i
all relevant facts concerning the Lawrence Livermore National Laboratories incident. (6)
(6) negligently failed to perform this duty. testi?ed that he did not include
any information in his brie?ng materials for Colonel King or the draft response to the DHHS-
010 about variations from the accepted viability testing procedures, particularly the destruction
of the vial containing viable Bacillus anthracis.454 His negligent failure to provide Colonel

 

See Tab B-30.l, page 2, (5) DA Form 2823, Sworn Statement (20 Aug. 2015); Tab B-11.2, pages

3-4, m, Addendum to DA Form 2823, Sworn Statement (10 Sept. 2015) stated ?He is very passive and

introverted; generally not the first one to provide feedback. When he did demonstrate a willingness to provide

feedback it was often after being asked. He generally defers to senior leadership positions, many times without

offering any recommendations or analysis of potential impacts?; Tab page 4, m?

Addendum to DA Form 2823, Sworn Statement (18 Aug. 2015) stated (6) ?really isolates himself in his

of?ce and only seems to care about what is going on before any inspection or VIP arrives.?

See Tab page 2, (6) DA Form 2823, Sworn Statement (20 Aug. 2015) stated ?it was

extremely hard for life sciences personnel to transition from extroverted people personW to quiet intr0verted
?am? It resulted in a morale de?cit for years"; Tab 34.1.21,  A en um to DA Form 2823

Sworn Statement (10 Sept. 2015) stated believe a lot of it is because of the loss of strong leadership; 

realIy did all he could to keep us all together. But he retired, and current management does not take as large a role

in fostering strong morale among the workers in the of?ce.?

Tab page M, (6) Addendum to DA Form 2823, Sworn Statement (21 Aug. 20l5).

?52 'l'ab B-11.2. pages 2, Addendum to DA Form 2823, Statement (IO Sept. 2015).

?53 See Tab 8-1 1.2, pages 8, Addendum to DA Form 2823, Sworn Statement (10 Sept. 2015).

45? See Tab 8-2.2, 6 MemOrandum for RecOrd, subject: TranSCribed Testimony 

eetlon . . . .i,t econtamlnatlont at cause tn eto at was Intro uced in the lab at DPG-LSD. This

tube was destroyed as a result, but the other four tubes were shipped to LLNL without being retested.

 
    
  
 

99

King this information adversely affected Colonel King?s ability to make an informed decision
regarding the incident. The failure to provide this information did not alleviate Colonel King?s
duty to take reasonable command action and review historical documents and correspondence
related to the LLNL incident in which information about the destruction of the ?fth vial is
readily available.

d. knew or should have known that he had a duty to maintain an environmental
sampling program (a laboratory best practice) in the biosafety level-3 suites at DPG-LSD but
failed to do so. Environmental sampling is a critical tool in ensuring biosafety and effective
laboratory work practices. The 15-6 investigation discovered live Bacillus anthracis Ames
spores outside of primary containment when conducting environmental sampling of DPG-LSD
Room 506. This could have been prevented, and the risk for contamination within the
laboratories at DPG-LSD could have been minimized, had DPG-LSD effectively executed a
routine environmental sampling program.455

6. knew or should have known that he had a duty to maintain a dedicated
quality assurance/quality control manager at both DPG-LSD and the CRP, but he failed to do so.
He placed personnel in positions where they were responsible for performing oversight of their
own operations. states ?The Quality function within the life sciences division is
currently assigned to our Biosurety Of?cer which makes him dual-batted. He does not have the
bandwidth to adequately address quality assurance for all processes across our division.?456
Furthermore, the quality function within the CRP is assigned to (6) making her dual-
hatted as well. Since 20  1, no one acted in a dedicated oversight capacity at DPG-LSD,
including the CRP.

f. had a duty to enforce the closed circuit television video surveillance
program required by Army regulations within the biosafety level-3 laboratory suites.457 (6)
(6) admits that he failed to adequately participate in this program and observe the
activities of subordinate employees.?8 Active participation in this program could have
uncovered poor lab practices and led to preventative measures, remedial training, or
environmental sampling being conducted within the which would have advanced the
safety and professionalism of his organization and prevented mishaps.

g. (6) I had a duty to ensure classi?ed information was not transferred through
unclassi?ed means and personnel were properly trained on security classi?cation guidelines. His
failure to ensure prOper training of personnel led to a violation of the CRP security classi?cation

 

4? See Section ll.C.l.b.vi, Failure to Execute an Environmental Sampling Program.

?56 See Tab B-2.l, page 2, (6) DA Form 2823, Sworn Statement Aug. is
clearly aware that quality assurance is not being adequately addressed at DPG-LSD.

?57 See Tab E-2, AR 190-17, para. 5~18. The evidence indicates that (6) delegated the day-to-day
responsibility for this duty to but (6) says in his sworn statement that he sometimes ?nds it
dif?Cult to break away from his other duties when it is his turn to view the video, indicating that he still maintains
this duty to some degree.

??53 See Tab B-2.l page l8, (6) Addendum to DA Form 2823, Sworn Statement Aug. 20] 5).

100

guide.?9 Subsequent to this security violation, (6) also had a responsibility to act, but
he failed to take disciplinary action against the personnel involved.460

h. knew or should have known that he had a duty to oversee all activities that
took place within the DPG-LSD, and is ultimately responsible for the actions and failures of all
DPG-LSD personnel. failed in this duty by not taking appropriate action at his
level of supervisory authority. This inaction created a culture that inhibited oversight,
introspection, and professional development of DPG-LSD personnel. For example:

(I) (6) should have questioned the alleged ?proprietary? nature of the CRP
work instructions and pseudo-compartmentalized operations of the personnel working on
products for this program. (6) was aware of the alleged ?proprietary? nature of the
CRP work instructions and operations for years; however, he failed to question DPG-LSD
personnel working on this program or the CRP leadership at Fort Detrick about the nature of this
alleged limitation.46' Additionally, he had a duty to inform the chain of command, regulatory
oversight personnel, and other staff members that the personnel working on CRP projects used
an additional work instruction that was not part of the DPG-LSD approved standard Operating
procedures. Moreover, there was no effort to ensure this work instruction was approved, in
compliance, or consistent with DPG-LS standard operating procedures and other regulatory
requirements.462

(2) had a duty to ensure that DPG-LSD personnel were aware of and
complied with reporting requirements for all incidents, including shipping errors.?3 He knew or
should have known he had this duty, but failed to execute it. This failure facilitated an
environment in which transparency and swift reporting of mishaps to the chain of command and
regulatory agencies did not exist.464

i. (6) was very c00perative and forthright with information during the
investigation.

 

?59 See Section ll.C.b.xii, Failure to Safeguard Classi?ed information and Ensure Personnel are Trained on
Classi?cation Guidance.

As 0f2 October 2015, the investigation team has not discovered any evidence to suggest thatME- has
disciplined any personnel for these failures.

461 

See Tab page l8, (6) Addendum to DA Form 2823, Sworn Statement (21 Aug. 20l5)
states ?My impression is that they are accountable for the same practices methods protocols as the rest of
life sciences division.? This statement shows My did not have knowledge or oversight of CRP internal
policy review and apprOVal process. For the supportmg acts and circumstances, see Section [1.0 Failure to
Properly Review and Approve Critical Reagents Program Internal Policies and Procedures.

?3 See Sections ll.C.I .b and II.C.2 for speci?c instances of improper mishap reporting.

Mishaps require reporting through the chain of command to ensure compliance with Department of the Army
Pamphlet 385-69, chapter and Commander?s Critical Information Requirements. personnel should
also be aware of CDC reporting requirements which are independent of these chain of command reporting
requirements.

101

 

Description)

(6)
W566 Tab 3-2.4 - (6) - Position

 

Duties:

Findings/Failures:

 

Planning, coordinating, and supervising
the Life Sciences Division programs

Directs operation of Life Sciences
Division laboratories for the production,
storage, quality control and ?lling of
biological materials, simulants, and
tracers

Reviews, analyzes, and evaluates
reports generated within the division for
overall technicai validity and adequacy.
Reviews test plans for adequacy and
feasibility taking into consideration the
resources and capability of the
organization to accomplish the stated
requirements and recommends changes in
data requirements or outlines necessary
recourses required to accomplish the test
plan.

Failed to fully investigate biological mishaps

Failed to maintain an environmental sampling
program

Failed to maintain a dedicated Quality
Assurance/Quality Control manager

Failed to maintain and utilize the video
surveillance program

Failed to question the proprietary nature of the
CRP Antigen Repository

Failed to maintain technical control/oversight
over the CRP team at 

Failed to review CRP SOPs in accordance with
process used for other DPG SOPs

Negligently failed to provide Colonel King with
all relevant information associated with the
LLNL mishap

 

Performs personnel management's
responsibilities for subordinates. Provides
administrative and technical supervision,
establishes priorities, assigns duties,
initiates personnel actions, 
recommends promotions, selects new
employees for vacancies, makes
rcassignments, handles minor disciplinary
problems, establishes performance

 

Negligently failed to take appropriate
disciplinary action in reSponse to mishaps

Negligently failed to supervise and lead
personnel

Negligently failed to hold personnel
accountable for lack of performance

Negligently failed to assess biosurety
quali?cations for DPG-LSD personnel

Failed to prevent and correct instances of
transfer of classified information through
unclassi?ed means

Failed to recognize and remediate complacency
at DPG-LSD, and potentially contributed to it
with his leadership style

 

Positive Findings: (6)

 

was very cooperative and forthright with information when
asked to provide it by the [5-6 investigation team

 

Figure 31: (6) Summary

l02

 


(6) had the following duties but failed to execute them:

a. had a duty to mentor, educate, train, and hold personnel accountable for
known de?ciencies. He also had a duty to prevent complacency within his Branch. He knew or
should have known that he had these duties, but negligently failed to execute them.
Additionally, had knowledge of (6) . poor laboratory practices and took no
action to correct them.465 He allowed repeatedly demonstrated poor lab
practices (as reported by several of her peers) to continue working on critical projects without
any professional development or corrective action.

b. had a duty to question the ?proprietary? and isolated nature of the CRP
resulting in compartmentalization of operations conducted in his Branch. He had a duty to
inform the chain of command, regulatory oversight personnel, and other staff members that the
personnel working on CRP projects were operating outside approved standard Operating
procedures. He had a duty to ensure that all standard operating procedures and work instructions
were properly reviewed and approved. knew or should have known that he had
these duties, but negligently failed to execute them.466 The personnel working in his Branch,
Speci?cally (6) and (6) operated without proper oversight and this may have
contributed to the unintended shipment of viable Bacillus anthracis.

c.knew or should have known that he had a duty to maintain an environmental
sampling program (a laboratory best practice) in the biosafety level-3 suites at DPG-LSD but
failed to do 50. Environmental sampling is a critical tool in ensuring biosafety and effective
laboratory work practices. The 15-6 investigation discovered live Bacillus anthracis Ames
spores outside of primary containment when conducting environmental sampling of DPG-LSD
Room 506. This could have been prevented, and the risk for contamination within the
laboratories at DPG-LSD could have been minimized, had DPG-LSD effectively executed a
routine environmental sampling program.467

d. (6) knew or should have known that he had a duty to maintain a dedicated
quality assurance/quality control manager at the CRP Antigen Repository, but he failed to do so
by assigning (6) to serve as the quality assurance/quality control reviewer other own
work.468

6. (5) had a duty to ensure that the death certi?cates were properly completed with
accurate information by his subordinate (6) (6) knew or should have known

 

See Section Il.C.l Failure to Take Action, describing lcadership?s repeated failure to investigate mishaps and
take appropriate disciplinary action.

See Section Il.C.l Failure to Properly Review and Approve Critical Reagents Program Internal Policies
and Procedures.

?67 See Section Il.C.l .b.vi, Failure to Execute and Environmental Sampling Program.

?53 See Section ll.C. .b.iv, Failure to Adhere to Production Based Practices.

103

that he had this duty. He failed to ensure that she had acourate data in the form before sending it
to the biosafcty of?cer and responsible of?cial for signature and certi?cation. He failed to
supervise (6) and allowed her to manipulate the data in the death certi?cates at any time,
unrestricted, and unbeknownst to the biosafety of?cer and responsible of?cial, both of whom
had duties to certify the accuracy of the data in this form.469

f. (6) had a duty to report biolosical mishaps to the Chief, DPG-LSD. He knew or

should have known that he had this duty. knew of and failed to report the
Venezuelan Equine Encephalitis event that occurred in 201 Due to his failure to report this
event, DPG-LSD had no oversight or ability to assist in correcting the failings associated with
this event.

g. had a duty to ensure classi?ed information was not transferred through
unclassi?ed means and personnel were properly trained on security classi?cation guidelines. His
failure to ensure proper training of personnel led to a violation of the CRP security classi?cation
guide.47' Subsequent to this security violation, (6) also had a responsibility to act, but
he failed to take disciplinary action against the personnel involved."72

h. (6) was not only forthright with information, but also accepted responsibility for
several of the failures that occurred within his Branch. (6) displayed an understanding

of the de?ciencies within the organization and expressed a desire to improve the operations of
the DPG-LSD.

 

 

 

Positions Held: (6) - - - (See Tab 3-273, (6) -

Position Description)

 

 

 

Duties: Findings/Failures:
Functions as them Failed to fully investigate and report biological
(W6) ft 1 crences mishaps

Division.

 

Manages a variety of complex technical Failed to maintain and utilize the video
and administrative activities involving the surveillance program

integration of level work and the
overall coordination of program and
business development activities within the
commodities of the Bio Technology
Branch.

 

 

 

 

 

See Section ?.01 Manipulation and Carelessness in Generating Bacillus anthracis Death Certi?cates.

47? See Section 11.01.11. Failure to Report and Investigate Biological Mishaps for facts and circumstances
surrounding the failure to report and investigate biological mishaps. See Section I.F.. Historical Mishaps a! Dug-nay
Proving Ground Life Sciences Division for facts and circumstances surrounding historical mishaps.

See Section Il.C.l .b.xii, Failure to Safeguard Classi?ed Information and Ensure Personnel are Trained on
Classi?cation uidance.

"2 As of 2 October 20 5, the investigation team has not discovered any evidence to suggest that has
disciplined any personnel for these failures.

104

 

Supervises development of applied test Failed to maintain an environmental sampling
methodology for new agents in the field of program
biology such as bacteria, viruses, toxins, Failed to maintain a dedicated Quality

biologically active compounds, smokes Assurance/Quality Control manager
and obscurants. Devises assay procedures Failed to ensure accuracy of death certificates
that are simple to perform and provide Failed to question the proprietary nature of the

data with statistically high reproducibility. CRP Antigen Repository
Devises methods for decontaminating or Failed to maintain technical control/oversight
inactivating those substances required as over the CRP team at DPG-LSD

 

challenge test materials. Failed to review CRP SOPs in accordance with
process used for other DPG SOPs

Performs personnel management Negligently failed to take appropriate disciplinary

responsibilities including scheduling and action in response to mishaps

assigning work to subordinates, Negligently failed to supervise and lead personnei

evaluating employee perfOrmance, giving Negligently failed to mentor, train, and hold

advice and counsel to employees, personnel accountable for lack of performance

recommending promotions, selections, Failed to prevent and correct instances of transfer

reassignments, etc., resolving employee of classi?ed information through unclassified
complaints, effecting minor disciplinary means

measures, identifying training needs and Failed to recognize and remediate complacency at
recommending training and promoting DPG-LSD, and potentially contributed to it with his
programs such as EEO, upward mobility, leadership style

etc.

Positive Findings: was not only forthright with information, but also accepted
responsibility for several of the failures that occurred within his Branch. displayed
an understanding of the deficiencies within the organization and expressed a desire to improve
the operations of the DPG-LSD.

 

 

 

 

 

Figure 32: (6) Summary

(1. DPG-LSD Oversight Staff

 

had the following duties but failed to execute them:

a. (6) had a duty to administer the biological safety/surety program at
DPG- knew or should have known that she had this duty, but failed to
perform it by not appointing a qualified individual to serve as the Biological Safety
(6) im so erl deleated the responsibilities of the Biosafety Of?cer to an (6)

in contravention of Army regulation. Due to the highly sensitive
nature of the work done at DPG-LSD and the regulatory requirement, should

have ensured the appointment of a Biosafety Of?cer with proper experience, training, and
Furthermore, (6) failed to ensure that the 

  

 

?3 (5)

See Section ILC. .b.x Failure to Ensure Biosafety Of?cer Quali?cation.

105

environmental sampling and video surveillance plans were effectively executed. This failure
limited ability to ensure the safety of the personnel working in its laboratories as
well as the safety of the public.

(6) 475 had a duty to
ensure that the death certificates were properly completed and contained accurate 
Although had the duty to certify that lots of Bacillus anthracis were inactivated
prior to shipping, the scientific gaps relieve her from being heid accountable for the inadvertent
shipments of viable Bacillus anthracis. Nevertheless, she should remain accountable for failing
to con?rm the accuracy of the data in the death certi?cates prior to signing and certifying them.

 

    

Position Description and Figure 17)

 

 

 

 

Duties: Findings/Failures:
 Failed to effectively administer
0 and is responsible for a variety of the biological safety/surety
technical and administrative tasks. program by failing to appoint a
Administers the Department of Army (DOD) Biological quali?ed biosafety of?cer
safety/surety program to support the Division Chief Failed to ensure that the DPG-
(Certifying O?icial) in the areas of safety information, LSD environmental sampling and
inspections, health hazard and risk mitigation education, video surveillance plans were
facility safety controls, engineering controls, biosafety effectively executed
practices, decontamination, and lab emergency reSponse. Failed to ensure accuracy of
Plans and assigns work, sets priorities, advises death certi?cates
employees on program management and division goals and
objectives and makes decisions on work problems
presented by subordinate employees. Responsible for
maintaining safe operating conditions in the biosafety level
3 laboratories at Life Sciences Division.

 

 

Figure 33. (bxs) ummary

had a duty to ensure that the death certi?cates
were properly completed and contained accurate information. (6) also had the duty to
ensure that proper oversight of the death certi?cate approval process was in place. (6)
routinely exercised this duty when he signed and certified that lots of Bacillus anthracis were

(6)

 

"5 See Figure 17 and Note 379lots and the m?

for 4 lots that were determined to Via a er initial inactivation.
47" See Section ?.01 Manipulation and Carelessness in Generating Bacillus anthracis Death Certi?cates.

106

inactivated and thus should no longer be considered biological select agents and toxins.?7 (5)
was unaware, but should have known, that (6) regularly manipulated data in death
certi?cates a?er all parties had signed and should have noticed that death certi?cates routinely
referenced improper standard operating procedures or work instructions.478 Although
had the duty to certify that a lot of Bacillus anthracis was inactivated prior to shipping, the
scienti?c gaps relieve him from being held accountable for the inadvertent shipments of viable
Bacillus anthracis. Nevertheless, he should remain accountable for failing to have a proper
certi?cate approval process in place to con?rm the accuracy of the data on the death certi?cates.

 

(5)

 

Positions Held: (6) and Tab
B-26.3, (6) - Bio and Resume and Tab CDC Responsible Of?cial Guidance

 

 

Document)

Duties: Findings/Failures:
(5)  ith line Failed to ensure
management responsibilities across the spectrum of the accuracy of death
Division?s mission and functions. certi?cates

The RO is the individual designated by the registered entity with the
authority and reSponsibility to act on behalf of the entity to ensure
compliance with the select agent regulations.

 

 

 

 

Figure 34: DIE?Summary
(6)

(5) had a duty to ensure that the

death certi?cates were properly completed and contained accurate informatiOn. (5)

knew or should have known that he had this duty, but he failed to execute it when he signed the
death certi?cate for lot The Biological Safety Of?cer is the ?rst line of
oversight in the death certi?cate process, and is tasked with reviewing the form after it has been
completed by the Principle Investigator and prior to sending it to the Res onsible Official for
?nal signature.480 While it has been established in this report thatmhwas not quali?ed
for and inappropriately delegated the responsibilities of the Biological Safety Of?cer position at
DPG-LSD, it is not beyond the scope of his education and experience to at least review
documents that he signs for accuracy and completeness. While (5) cannot be held
responsible for not effectively administering the DOD biological safety/surety program at DPG-
LSD due to his lack of appropriate quali?cationsf? he should not be relieved of accountability
for administrative tasks such as death certi?cate data review. Althoughhad the duty
to validate the data on the death certi?cates and ensure that the correct inactivation standard
operating procedures were followed, the scienti?c gaps relieve him from being held accountable
for the inadvertent shipments of viable Bacillus anthracis.

 

?77 See Figure 17. (6) was th for 4 lots of Bacillus anthracis that were determined to be

viable a?er initial inactivation, to include two lots signed for mm at (6) direction.

"8 See Section Il.C.l Manipulation and CareleSSness in Generating Baci us anthracis Death Certi?cates.
"9 See Figure 17' and Tab C-l9, Death Certi?cate for Lot AGD0001667 (I8 Mar. 2014).

See Section LL, Background Discussion on Death Certi?cates.

It is recommended that [Em?be held accountable for this failure.

107

 

Positions Held: - Position
Description)

 

 

Duties: Findings/Failures:
Serves as the - responsible for leading team Failed to ensure
members in the development, coordination, implementation, and evaluation accuracy of death

of inspections as directed by higher command relating to Biological Safety, certi?cates
Surety, and biological security at Life Sciences and other sites on Dugway.
Takes the leadership role in overseeing and carrying out inspections that
supports and conducts comprehensive evaluations of biological safety
program, biological surety, and biological security program for compliance
with regulatory requirements.

Enforces regulations and takes a pro-active approach based on education,
outreach, and training.

 

 

 

 

Figure 35: ummary
(6)

(6) 82 had a duty to ensure that the
death certi?cates were properly completed and contained accurate information when he reviewed
them in lieu of the Responsible Of?cial. knew or should have known that he had
this duty, but he failed to execute it when he signed the death certi?cate for lot 
Although, had the duty to validate the data on the death certi?cates and ensure that
the correct inactivation standard operating procedures were followed, the scienti?c gaps relieve
him from being held accountable for the inadvertent shipments of viable Bacillus anthracis.
Nevertheless, he should be held accountable for failing to validate the data in the death
certi?cates prior to signing and certifying them.

 

(6)

 

 

 

- - Position

Positions Held: 
Description and Tab 13-39 CDC Responsible Of?cial Guidance Document)

 

 

 

Duties: Findings/Failures:
Performs the duties of th de?ned as the individual Failed to ensure accuracy of
designated by the registered entity with the authority and death certi?cates

responsibility to act on behalf of the entity to ensure compliance
with the select agent regulations, in the absence 0%

Figure 36: Mr. Donald Simmons Summary

 

 

 

 

 

?2 The Responsible Of?cial is required to review and sign the death certi?cate as per DPG-LSD policy (not a CDC
requirement). The Alternate Responsible Of?cial is empowered to conduct the review when the Responsible
Of?cial is unable to do so. ?XE-was approved as an by the CDC in 2010 (Tab (3-51, DPG-LSD CDC
Registration and Designation 220ctl 2 to 220ct15-l9, Death Certificate for Lot AGD0001667 (l8 Mar. 2014 and Tab 8-26.13, page 4,
(6) Addendum to DA Form 2823, Sworn Statement 19 Aug. 20 5). [Elia-signed as. the


   
 
  

on behalf of mWho was on annual leave from l7-l8 March 2014.
108

e. DPG-LSD Laboratory Technicians

(6)

1pments, a owmg uties ut ale to execute them:

a. had a duty to practice safe laboratory procedures. knew or should
have known that she had this duty, but failed to perform it. During a review of laboratory
practices through closed circuit television camera recordings at the DPG-LSD, the 15-6
investigation team observed (6) opening a shaker incubator containing biological agents
in liquid culture without wearing a powered air purifying reSpirator. At approximately 0808
hours on June 14, 2015, (6) entered room 506 in the DPG-LSD without wearing a
powered air purifying respirator. (6) then opened the shaker incubator which contained a
series of Erlenmeyer ?asks with liquid cultures of biological agents. According to the standard
operating procedures contained in WDL-SAF-330, Safety Guide for Working in High-
Containment BSL-3, all employees must wear a powered air purifying respirator during aerosol
generating procedures.484 The movement of the shaker incubator combined with the liquid
culture meets the de?nition of an aerosol generating procedure, therefore was
required to wear a powered air purifying respirator during these activities. By not wearing a
powered air purifying respirator during these activities (6) risked exposing herself to
biological select agent and toxins.

b. had a duty to properly calculate and document the data contained in the death
certi?cates that she prepared. (6) new or should have known that she had this duty but
failed to perform it. On more than one occasion she documented the incorrect dosage that a lot
was exposed to during irradiation. This incorrect information was ultimately sent to the
biosafety officer and responsible of?cial to certify that a lot of Bacillus anthracis was properly
inactivated. Furthermore, admitted to manipulating the data on the death certi?cate
for lot AGD0001667 after the Biosafety Of?cer and Responsible Of?cial had signed the form.486
She then did not notify those previous signatories that she was making these substantive edits to
the form after it was certi?ed.487 - was willfully negligent. She intentionaliy modi?ed
the death certi?cates after they had already been signed by her superiors, destroying the
credibility of the death certi?cate validation process. While the improper documentation and
subsequent modi?cation of the data on the death certi?cates was not a direct cause of the

 

48? All employees performing work in ESL-3 laboratories at DPG-ISD are aware of and trained to this standard
operating procedure.

?35 Powered air purifying respirators protect laboratory staff during manipulations of potentially infectious aerosols
in two different ways. First is through the use of the High Ef?ciency Particulate Air Filters on the powered air
purifying respirator which ?lters at least 99.97% of all air particulates when used appropriately. Second is through
mucous membrane protection since the powered air purifying respirator face shield covers the eyes, nose and mouth
during operations. This can prevent any potential transfer of infectious agents from gloved hands to the mucous
membranes if personnel touch their face during laboratory procedures.

?6 See Tab B-44.2.a, page 8. (6) ddendum to DA Form 2823, Sworn Statement (Aug. 2015).

See Section ll.C.l Manipulation and Carelessness in Generating Bacillus anthracis Death Certi?cates.

109

shipment of viable Bacillus anthracis, they indicate poor laboratory data accounting and an

inadequate overall quality control process.

0. (6)

had a duty to oversee the work of (6) (6)

knew or

should have known that (6) was executing poor lab practices and should have taken
corrective action to eliminate these practices. The 15-6 investigation team reviewed video

surveillance footage and noted several instances wherein (6)

exercised poor laboratory

practices.488 These direct observations were corroborated by the testimonies of several DPG-
LSD personnel. (6) failed to review video (or directly observe) and address (6)

poor laboratory practices.

d. (6) had a duty to report numerous shipping incidents to the DPG-LSD chain of
command. The incidents include the December 2010 Burkholderia mallez' shipment and the

 
   

September 2014 Vaccinia shipment. (6)
duty, but she failed to execute it.489 Since (6)

knew or should have known that she had this

failed to report these incidents to the DPG-

LSD490 chain of command, it was not possible for leadership to comply with regulatory reporting
requirements and/or take corrective or disciplinary action.

e. (6) had a duty to ensure classi?ed information was not transferred through
unclassi?ed means and to ensure personnel were preperly trained on security classi?cation
guidelines, but failed to execute it during the CRP data review conducted in June 2015??

 

 

Positions Held: (6) (See Tab B-44.3,

  

 

 

- Bio and Resume)

 

Duties:

Findings/Failures:

 

Test of?cer managing the day-to-day
operations of the Critical Reagents Program
(CRP) Antigen Repository.

Plans, schedules, and monitors ali bacterial
antigen production phases within the CRP
Antigen Repository.

Monitors and approves all batch records and
technical data for bacterial antigen production
prior to shipping these antigens to customers.
Develops and reviews SOPs and internal
operating procedures for microbiological and
analytical assays.

 

 

Figure 37: (6)

 

 

Failed to practice safe laboratory procedures
Failed to properly calculate and document the
data in the death certi?cates and negligently
manipulated signed death certi?cates

Failed to properly oversee the work of
subordinate employees, particularly Ms.
Marlene Bragg

Failed to report numerous shipping incidents
through the DPG-LSD chain of command

Failed to prevent and correct instances of
transfer of classi?ed information through
unclassi?ed means

 

 



48? See Section il.C.l.b.vii, Failure to Maintain a Viable Video Surveillance Program.

?89 See Section Historical Mishaps at Dugway Proving Ground Life Sciences Division.

53!? did not report these events to the chain of command; however, she re orted them to the
lea ership at the Critical Reagents Program at Fort Detrick, MD. See Tab 13-44221, page 8,m-
Addendum to DA Form 2823, Sworn Statement (Aug. 2015).

See Section il.C.l.b.xii, Failure to Safeguard Classi?ed information and Ensure Personnel are Trained on

Classification Guidance.

llO

 (5)

a. knew or should have known that she had a duty to follow safe laboratory
procedures. She negligently failed in this duty multiple times as observed by the 15-6
investigation team during review of surveillance video.492 Other personnel at DPG-LSD have
observed (6) working with more than one organism, working with multiple strains, and
working with both live and inactivated materials under a biosafety level-3 cabinet, which
increased the risk of cross contamination.493 [n 2007, (6) was allegedly observed taking
an irradiated organism out of a biosafety level-3 laboratory the day the organism was irradiated
without performing viability testing.494 In 2013, (6) was observed taking an irradiated
organism out of a biosafety level-2 laboratory the day the organism was irradiated without
completing viability testing.? More than one laboratory technician has indicated that they do
not want to work in the laboratory with due to her poor lab practices.496 These poor
laboratory practices could have exposed employees working in biosafety level-3 to biological
select agents and toxins on more than one occasion.

b. knew or should have known she had the duty to report a spill of biological
select agent and toxin outside primary containment. negligently failed in this duty
when she did not report that she dropped a sample plate outside of primary containment and also
failed to subsequently decontaminate the laboratory. 497 Army Pamphlet 385-69, Safety
Standards in Microbiological and Biomedical Laboratories requires that an incident of this nature
is reported immediately after it occurs.498 There was no documentation of this mishap being
reported to either the DPG-LSD, the West Desert Test Center Safety Of?ce, or the CDC.
Therefore, no corrective actions could be made by leadership.



c. (6) was assigned the duties of the or
the CRP Antigen Repository. There is insuf?cient evidence to su on a conclusion that she
failed in these duties, however, as stated in the ?ndings against 
(6) these duties should have been assigned to a dedicated (6)

(6)

 

?92 See Section 11.C.l.b.vii, Failure to Maintain a Video Surveillance Program.

See Tab B-34.l, (6) DA Form 2823, Sworn Statement (10 Sept. 2015); Tab 40.1, (6) DA
Form 2823, Sworn Statement (27 Aug. 2015); Tab B-l2.l, (6) DA Form 2823, Sworn Statement (26
Aug. 2015); Tab 35.2, (6) DA Form 2823, Sworn Statement (20 Aug. 2015).

See Tab B-34.l, (6) DA Form 2823, Sworn Statement (10 Sept. 2015). There is no further
corroborating evidence besides this statement, and (6) denies having done so.

?95 Id. Biosafety level-2 organisms, while not as dangerous as biosafety level?3 organisms, can still cause illness in
humans and are sometimes inactivated and tested for sterility similar to biosafety level-3 organisms.

49" See Tab B-34.l, (6) DA Form 2823, Sworn Statement (IO Sept. 20l5); Tab 40.1, (6) DA
Form 2823, Sworn Statement (27 Aug. 2015); Tab B-l2.l (6) DA Form 2823, Sworn Statement (26
Aug. 2015); Tab DA Form 2823, Sworn Statement (20 Aug. 2015).

See Section ll.C.1.b.vn, at ure to Maintain a Viable Video Surveillance Program.

493 See DA PAM 385-69, Chapter I.



 

 

 

 

 

 

 

(6)

Positions Held: (See Tab 8-5.2, (6) - Resume)

Duties: Findings/Failu res:
Planning and executing the cultivation, harvest and down-stream Failed to practice
processing of bacteria, viruses, and toxins/toxoids. safe laboratory
Maintain an antigen repository of primary/secondary stocks of viruses, procedures
toxins and bacteria. Failed to report a
Maintain accountability for compliance, sustainment, and monitoring. Spill of biological
Develop and evaluate resources and activities to maintain an effective select agent outside
quality assessment (QA) plan, carry out internal audits, and facilitate of primary
external audits. containment

 

 

 

 

Figure 38: (6) Summary

(5)

(6) had a duty to ensure that all
agents were prepared, packaged, and shipped in accordance with Federal, state and local
regulations.499 Furthermore, she had a duty to report all shipping errors to her supervisors, (6)

(6) 00 (6) is negligent in that she failed

in these duties when she made the following erroneous shipments:

a. in July 2010, the Naval Surface Warfare Center in Dahlgren, Virginia received a
shipment from DPG-LSD containing Venezuelan Equine Encephalitis TC83 in lieu of the
Bacillus anthracis (Sterne strain) they had ordered. The intended vial of Bacillus anthracis
Sterne ordered from the CRP that was supposed to be shipped to the Naval Surface Warfare

Center had inadvertently been sent to (6) a private laboratory at La Jolla,
California. (6) failed to ensure the shipments went to the appropriate customers. (5)

(6) was the technician responsible for these erroneous shipments.?

b. On three separate occasions (27 February 2008, 20 October 2010, and 17 November
2010), shipped regulated quantities of Botulinum neurotoxin A, a regulated select
toxin, to two separate entities (shipping BSAT material without all of the safety procedures in
accordance with 42 CFR part 73). In all three cases, (6) violated DPG-LSD standard
operating procedure by not determining the proper classi?cation of the
biological material prior to shipment. (6) was the technician responsible for these
erroneous shipmentss02

c. In December 2010, the Naval Surface Warfare Center, received a shipment from DPG-
LSD of inactivated Burkholderz?a mallei that had an incorrect lot number on the vials, thereby not
matching the enclosed death certi?cate, or the accompanying certi?cate of analysis, or the

 

See Tab 3-173, (6) Performance Evaluations, DA Form 7222 (201 1-2014).
59? Id.
See Section I.F., Historical Mishaps at Dugway Proving Ground Life Sciences Division.
Id.

112

shipping documentation. (b) (6)
failed to ensure the shipment contained accurate shipping
documents to match the items shipped. (b) (6)
was the technician responsible for this
erroneous shipment. Additionally, she failed to report this mishap to the DPG-LSD chain of
command. 503
d. In September 2014, a shipment of “inactivated” Vaccinia from DPG-LSD to Naval
Surface Warfare Center, was mislabeled with an incorrect lot number and “Live” Vaccinia
nomenclature. Viable Vaccinia virus can be a human pathogen, making the live strain a Risk
Group 2 organism. Instead of the correct label with inactivated Vaccinia, lot number
AGD0000219, incorrect labels stating viable Vaccinia, lot number AGD0000182 were applied to
the labels. (b) (6)
failed to detect that the incorrect lot number was being shipped. She
failed to report this mishap to the DPG-LSD chain of command. 504
e. In March 2014, (b) (6)
shipped a mislabeled package to the Republic of Korea
containing inactivated Bacillus anthracis from lot AGD0001667 and attenuated Yersinia pestis.
The shipping label described the contents as “4 mL KILLER ORGANISM ON DRY ICE,
UN1845.” (b) (6)
did not catch the typographical error on the shipping documentation
when she labeled and shipped the package. She failed to report this mishap to the DPG-LSD
chain of command. 505
(b) (6)

Positions Held: (b) (6)
Description)

(See Tab B-17.2, (b) (6)

Duties:
* Manage the biological agent repository and will develop
a system to ensure that reference (stock) materials meet
quality, surety and security requirements.
* Obtain and maintain certification for Transport of
Biomedical Materials Division 6.1 and 6.2 materials and
oversee the coordination of shipments and transfers of all
life science organisms.
* Works in BSL-2 and BSL-3 laboratories and ensures that
agents are prepared, packaged and shipped IAW applicable
Federal, Army, State, and local regulations.
Figure 39: (b) (6)

- Position

Findings/Failures:
* Negligently failed to ensure that
all agents were prepared,
packaged, and shipped in
accordance with Federal, state and
local regulations.
* Negligently failed to report all
shipping errors to her supervisors.

Summary

503

Id.
Id.
505
Id. Note that the material sent to the Republic of Korea was from the same lot (AGD0001667) as the one at the
center of this investigation. This lot was believed to have been inactivated at the time of shipment, so this really was
simply a typographical error even though subsequent viability re-testing has shown that this lot was not completely
inactivated.
504

113

 111. Recommendations
A. Scienti?c

The [5-6 investigation team concluded that a preponderance of evidence does not support a
?nding that a group of individuals or institutions were directly responsible for the inadvertent
shipment of viable Bacillus anthracis. However, a potential contributing factor is a gap in
scientific understanding of the irradiation and viability testing processes. The US. Army should
consider the following: 

I. Collaborate with the DOD and the CDC to revise current policy and regulations,
including 42 Code of Federal Regulation part 73, to define ?Non?Viable Select Agents? and to
determine how to demonstrate non-viability of a select agent. Furthermore, the and CDC
should consider allowing exempted amounts (below an infectious dose) of material to be treated
as non-select agent and consider eliminating or re-categorizing inactivated biological select
agents and toxins to account for the fact that it is not possible to verify that material has been
inactivated with 100% certainty.

2. Conduct studies to evaluate factors that could affect Bacillus anthracis spore resistance
to gamma irradiation. A variety of factors can affect resistance to gamma irradiation to include:
the strain of Bacillus anihracis, (ii) the concentration of spores in the solution being
irradiated, the total number of spores being irradiated, and (iv) the purity of the spore
solution being irradiated. Care?illy controlled studies using varying doses of gamma irradiation
should be conducted to evaluate each of these factors as well as the potential confounding effects
of multiple factors. The desired outcome would be the deveiopment of kill curves for selected
strains and spore concentrations of Bacillus anthracis under controlled conditions that could be
replicated by production facilities.

3. Conduct studies to evaluate the potential for gamma irradiated spores to heal. For
growth to be detected during viability testing, dormant spores (that were not actually killed
during irradiation) must germinate first in order to begin growing. The triggers that allow for
this transition are not clearly understood; however, there is evidence that suggests that time,
variance in temperature, salt content, air pressure and nutrients dramatically affect germination
and growth rates of spores. There is also evidence that the introduction of a catalyst could spur
the onset of germination within a damaged germinating spore. The catalyst could be any number
of potential factors including, but not limited to the following: time, incubation temperature, a
freeze thaw cycle, or the introduction of growth media.

4. Conduct studies to evaluate factors that could affect viability testing of irradiated
Bacillus anthracis spores: Key to the establishment of an effective Bacillus anthracis irradiation
program is the establishment of a validated means of assessing the viability of the irradiated
spores. In order to ensure that irradiated spores have truly been killed, conditions should be
provided that optimize the opportunity for growth. Factors to evaluate under viability testing
include: length of time spores are incubated in broth and on plates, types of growth media used
for incubation in broth and on plates soy agar, brain heart infusion agar, nutrient broth,

ll4

etc.), temperature(s) for incubation in broth and on plates, and the portion of the irradiated
sample that should be used for viability testing.

B. Institutional
1. US. Army

To reduce the risk of future mishaps involving biological material, the US. Army should
consider the following:

a. Unity ofCommand/Consolidation of Facilities

i. Appointing an Executive Agent with oversight over the laboratories at DPG-LSD,
ECBC and USAMRIID as well as any other entity working with biological select agents and
toxins administered by the Department of the Army.506

ii. The Executive Agent should study consolidation of the laboratories involved in
working with biological select agents and toxins in order to leverage unity of command and
minimize risk.

The Executive Agent could assist in the development ofcommon policies related to
laboratory practices, cross fertilization of lessons learned/best practices, increased
communication between colleagues and provide incentive to cross-talk between organizations.

iv. The Army should consider working with the CDC to create policy that addresses
how correspondence between the CDC and Army biological laboratories is delivered to the chain
of command. Currently communications occur between CDC representatives and the
Responsible Of?cials at each individual laboratory, so reporting of signi?cant events that may
require action by senior leaders is not required or guaranteed by existing policy.

v. The Army should study whether opportunities exist to reduce risk by partnering with
industry for the production and services of biological select agents and toxins in lieu of
maintaining this capability internal to the Army.

vi. The Army should consider removing the CRP operations from DPG-LSD and re-
align it under another laboratory (whether government or commercial) that may be better suited
to execute production for external customers.

b. Mobile Training Team

Executing a mobile training team, comprised of ievel microbiologists from ECBC,
USAMRIID, NMRC, and CDC, to travel to DPG-LSD to initiate a complete review of
laboratory practices and procedures at DPG-LSD. The main goal of the mobile training team
should be to improve laboratory processes and procedures by sharing commonly accepted
practices as they apply to production facilities.

 

50" The 15-6 investigation team understands that this recommendation has already been executed.

115

c. Developmental Assignments

Establish programs wherein all Army laboratories exchange personnel to facilitate
collaboration and development of best practices. The expectation is that cross-pollination of
knowledge, experience, and best practices will occur, allowing for the intellectual development
of associated personnel, as well as the advancement of science. Furthermore, it will create a
culture among the labs that will allow for better communication and collaboration.

d. Professional Development of Biological Research Personnel

i. Review conference and symposium attendance policy for biological research
personnel. Conferences and symposia are critical information exchange venues for this
community, and are key opportunities to promote professional education and collaboration with
commercial industry.

ii. Implement a formal mentorship program to ensure that personnel engaged in work
with all aspects of biological select agents and toxins, to include laboratory technicians, safety
personnel, regulatory oversight personnel, and inspectors, are adequately trained. The
mentorship process should include an annual sidewby?side, in?person peer review.

e. Hiring Incentives. Leverage existing incentive programs to attract and retain highly
quali?ed scientists to DPG.

f. Inspections. Work with the CDC to enhance the effectiveness of joint inSpections. The
following ?ve critical areas should be considered:

i. Frequency of Inspections. the various inspections (Federal Agencies,
Army, and Command) to ensure adequate overall inspection frequency.

ii. Noti?cation of Inspections. Implement unannounced inspections.

Scope of Inspections. Review the scope of inspections to include production
standards and protocol process reviews. Appoint a scienti?c protocol review audit team to
review the validity of inactivation and viability testing protocols. Current inspections primarily
focus on compliance and conformance related matters not technical matters. This
recommendation is aligned with the recommendations of the Review Committee Report.

iv. Composition of Inspection Teams. Ensure inspection teams are comprised of
subject matter experts with Operational experience and familiar with the current scienti?c data
and standards in the areas to be inspected. Each team should include microbiologists and
credentialed biosafety professionals with experience in working with biological select agents and
toxins. Command representatives should review inspection reports for Army wide implications.
These issues should be submitted to the Of?ce of the Director of Army Safety to be presented to
the Department of the Army Biological Safety and Health Council in order to update Army

116

policy. The council serves as the peer review forum for discussion of lessons learned and
recommendations for policy deveIOpment.50i

v. Department of the Army Inspector General Reviews. Convert the Army Biological
Surety Inspections, which are required by AR 50?] to be a mix of non-rated and rated508 reviews
that focus on systemic, non-scienti?c issues such as security, accountability, personnel
reliability, equipment maintenance, emergency response, medical services, and external support
issues. Rated reviews hinder open dialog, honesty about de?ciencies, and the overall
effectiveness of the reviews. Furthermore, it creates the perception that the inspected
organization is trying to avoid ?failing? at all costs.

2. US. Army Test and Evaluation Command
The Army Test and Evaluation Command shouid consider the following:
a. Complacency. Investigate whether complacency is widespread throughout DPG.

b. Personnel Quali?cation. Assess and ensure that all personnel assigned to biosafety,
biosurety, and scienti?c positions are quali?ed.

c. Mishap Investigation and Reporting. Ensure all mishaps are internally investigated and
that responsible parties are held accountable if appropriate.

(1. Review Army Regulation 7024 1, Army Quality Program, and determine whether ATEC,

DPG, and are in compliance with this regulation as it relates to the production of
Bacillus anthracis and other biological materials.

3. Dugway Proving Ground Life Sciences Division (DPG-LSD)

The leadership at Dugway Proving Ground and the Life Sciences Division should consider
the following:

a. Quality Assurance/Quality Control Program

i. Resource and ensure external oversight of a full-time Quality Assurance/Quality
Control Manager position.

ii. Execute and enforce the existing environmental sampling/inspection program.

DeveIOp and enforce production procedures that prohibit operations where live
select agents are used in the same laboratory where viability testing is conducted.

 

507 See AR 385-10, para. 2?1 8 (27 Nov. 2013).

503 The current reviews are rated, meaning they can result in failing de?ciencies and negative action against the
inspected entities. Non-rated inspections have the potential to be more effective in that they remove the incentive for
an entity to hide de?ciencies and instead focus on process improvement rather than simply ?passing? the inspection.

117

iv. Prohibit production work on multiple organisms or multiple strains of one organism
within the same biosafety cabinet.

v. Develop the existing video surveillance program and utilize the video as a tool to
improve laboratory practices in accordance with regulatory requirements. Ensure that closed
circuit television cameras are placed in locations that are conducive to the proper monitoring of
safety, security, and general laboratory practices within the laboratories, including inside the
biosafety cabinets.

vi. Implement formal, recurring data reviews of CRP processes in an effort to identify
trends and issues before they affect end products.

vii. Established validated protocols for CRP production processes to ensure that process
deviations are adequately vetted prior to implementation.

Enforce maintenance and calibration procedures and schedules for all CRP tools and
equipment. When necessary, contract with vendors to ensure that repairs are adequate and
thorough.

ix. Develop and enforce maintenance procedures and schedules for irradiators.
b. lntemal Policies and Procedures

i. Ensure that all standard operating procedures and work instructions governing
operations at DPG-LSD are nested as appropriate and subjected to a uniform review and
approval process. Notify the chain of command and request approval from the Director of DPG-
LSD prior to implementing any deviations from standard operating procedures.

ii. Ensure that the irradiator source decay curves are consulted, in conjunction with the
readings from the dosimeters, when calculating required time for irradiating a sample. Any
issues with the irradiator should immediately be brought to the attention of the Radiation Safety
Of?cer, the Radiation Safety Committee and the DPG-LSD Director. All individuals operating
irradiation equipment should receive documented comprehensive training on the equipment.

Revise the death certi?cate process to restrict the modi?cation of certi?cates after
all reviewers have signed the document. Train the signatories on their respective responsibilities
to establish a better understanding of their responsibilities and the importance of a critical review
of the certi?cate. Amend the certi?cate to accurately re?ect the protocol and work instructions
that are being followed. Also consider reverting to the ?inactivation certi?cate? title.

c. Personnel Quali?cation. Assess and ensure that all personnel assigned to biosafety,
biosurety, and scienti?c positions are quali?ed and ?Jlly vetted by the Biological Personnel

Reliability Program, as appropriate.

(1. Mishap Investigation and Reporting. Ensure all mishaps are investigated and
appropriately reported and that responsible parties are held accountable, as appropriate.

118

e. Hiring Incentives. Leverage existing Army incentive programs to attract and retain highly
quali?ed scientists.

C. Individual Accountability

A preponderance ofthe evidence does not exist to support a ?nding that a group of
individuals or institutions, or a speci?c individual or institution was the proximate cause for the
unacknowledged and unintended shipment of viable Bacillus anthracis. Nevertheless, failures
by leadership, oversight staff, and laboratory technicians were identi?ed across the DPG-LSD
enterprise. These failures may have contributed to the inadvertent shipment ot?viable Bacillus
anthracis. The following individuals should be held accountable for their respective failures as
addressed in Section 11C above.

1. The following leaders should be held accountable for their failure to take action:
a. Brigadier General William E. King, IV (See Figure 29 for Summary of Findings)
(6)
(5)
(6)
(5)

2. The following personnel with oversight responsibilities should be held accountable for
their failure to take actionThe following individuals should be held accountable for failing to exercise due care
in the performance of their duties:

(5)

(5)

 

ll9

The following individuals should NOT be held accountable no failures have been identi?ed:

a. Major General Daniel Karbler

b. Major General(R) Peter Utley

0. Major General(R) Genaro Dellarocco
d. Dr. James Streilein (8138 Retired)

0. Major General(R) Roger Nadeau

f. Major General(R) James Myles

g. Major General(R) Robert Armbruster
h. Major GeneraE(R) Del Turner

i. Mr. David Jimenez (SES)

j. Mr. Michael Etzinger (SES)

k. Mr. James Johnson (SES)

l. Brigadier General(R) Michael Combest

m. Brigadier GeneraI(R) Marvin Keith McNamara
b) (5)





120

IV. Conclusion

No single event, discrepancy, individual or institution caused the inadvertent shipments of
low concentrations of viable Bacillus anthracis samples from DPG-LSD. The evidence
collected is insuf?cient to attribute any action or inaction by any institution and/or individual as
the likely cause.

Although the facts do not support a speci?c ?nding ofwhat likely caused the viable
shipments, a number of scienti?c, institutional, and individual conditions/actions existed that
may have contributed to the unintended shipments of low concentrations of viable Bacillus
anthracis between 2004-2015.

To effectively remedy the issues identi?ed in this report, the Army should consider
implementing the aforementioned recommendations as a holistic approach to resolving the
numerous scienti?c, institutional, and individual de?ciencies associated with the inactivation of
Bacillus anthracfs.

OSTROWS KI . PA L. 155mg

cu=DaD. 

ADAMJ 1 15533769 

PAUL A. OSTROWSKI
MG, USA
Investigating Of?cer

121

Appendix A: Enterprise View of Mishaps and Personnel (2003jresent)

 

 

 

 

 

 

 

2015 2014 2013 1012 2011 2010 2009 2008 2007 NEG 2005 2034 2003
mmy It? mu commandmg acne?. MG Narblur MG Peter Ullcy I Mt: urn;er tic? arorco 7 Mt, ?on? I M5 ?mm My.? MG Ruhr? Amman!?

 

 
 
  

 

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Wrilram King

I Commander

    
  

 

 

Director WDTS WDTS 7? 
DPG Bros-Jrutv 
OIL-mural Suluty - 
DPG Saietv Olhce Ch-el 


   
 

 

DPG B-osalety thtel
Deputy Tech 

  
 



 
 
  
   
  
 
 
 

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WDIC Director

 

 

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V. 
Center I WDYC) WDYC Commander

 

 

    

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lrquc'enms 

 
 
  
   

 

 
  

 

 
 
    
  

 
 
 
 
   
  

   
  
 
 

(DPG LSD)
ore-150mg Durctlof 
a 
Microbrology Br Cine! um? Mum" and cum?Jm-r
Humming-wan! Control Contractor Samar Brolnb techmruan
Dual-1y Mung-mm
Mxrrohmtogm Contractor - - 
OW Ant-Ken Repommy
Branch pman .nwm?umr

 

Contmuor 



 

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Cunttactol Scientist CRP

Contractor Ass'r Suenusl

 

  
 

 

RSI branch ('hrol ErnaatutyOllru-r

   
 
 
  

  

Bro Stowpc Custadran Admumtrnuvc A?aSlSlam  Shippmg 

   

Regulator ry Sc arm: and
Inr?ovatronmsu Erasurcly Of?cer
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Contractor Lab loch/Assocmtc 

   

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201405 lot 1667 200905: to: lots (157. mm

   
  



Lu! 1039

    
  

date and Iut number ta'l :ol
numbun beam pt-nu signed the 

by 

CDC reportable; fine pending

    

201409; Lot 1631

  

ZED-108 lots 05). I, 0516

      

   

    

101.124: Lot rm 200710: WW tots 079-4, 0795, m, 0610

       

    

Lol 09m

   

   

 

 

ZDCQOG. 2m: LCIOSBZ

 

 

 

 

 

2015 201? [13 1012 201] 2010 2009 2003 2007 zoos

 

Critical ltoapenti'rogram (Cit?) laboratory contamination: the AR 15-6
4 4 _ulthe ESL-land BSL-Siabs used bvtheCRP
- Fwe samples positive torsocrlfus i8. onthroaslAmes strain in the 85t~3 lab
- DPG-LSD notllied CDCperSelect Agent sentan investigationtearmo
DPG. tinds B. an thmcis Sterne straminon- BSATiconlaminatlon in an other lab

CDC tine pending

 

 

 

Vlrus astree (Lister) shipment. Navd Surface Warfare Center (NSWC):
- NSWC re lots 0! inactivated Vacdnta from DPG sends vials that
are nuslabe I: as live; NSWC did not note lab el discrepancies
- sent 2 vials to Mt dwest Research lnstitule MRI :1 oted that label lot
nu rnber did not match certi?cate lot umber
- NSWC noted that labels are lot live Vaccinia (per lot number and WP on label)
- DPG LSDnotllied NSWC that the requested lnactivated lot was sent with the wrong
label. Not reportable to the CDC

 

 

B. Yuslnlopesti?s?l'. Penis) shipment. Reputation! Korea
- sent sample at inactivated agents to 8.0nthrocis and Y. pestis to Korea; typo
on shippinglabelread instead ot'KluID. Not reportable to the CDC

 

 

DurHloIrledo mallet mallet} shipmth NSWC:

DEG-ISO sent sam ple ol inactivated amalwi to NSWC: that label did not match
cert-lime (missing dl lot number; concentration not listed the same!

- uswc Mime 0 ol label and certificate errors; DPGtold NSWC to correct
lot number; NSWC declined; DPG se nt la bets and cc minute

- New label had dilierentatlmot number than original; reversed
concentration andsenom lC equivalent value. Not reportable to the CDC

 

 

Venezuelan Elaine Encephalitisz shipment. NSWC:

- DPG-LSD shipped inactivated EE to NSWC instead ol reque sled inactivated

Ronni rad! Sterne

- uswc LSD m;  provided the death certificate
and tech data or the vet. DVD-LSD . con?rmed that the wrongvul had been
shipped (a switch with a shipment I ntenced lor a private company)
- Notreportable to the CDC

 

 

touln shipmentto and Naval Medical Research 

- UPC-LSD shipped Botultn umtoxln itwloehnd um; 0.1 mg was requested
and theta! mg was sent (an amount exempt lrom
select toxin requirements!

- 1.0 mg actually sentiasnotedon label]; should have been shipped asa 
CDC approval
- CDC investigation assessed; 
declined to impose penaltvlindmdualuo to 5m. entity upto 5500:]

 

 

a. tawnnoe uimmore National laboratory 

- inactivated B. anthmas with 
one at we Vials tested positive and was destroyed; 
issued death certi?cates with noaddit-onal testing

- DPS-LSD shipped8.anthrocis to test all sample found uowthtone spore]
- CDC investigatlomdentiiled DPG-BDassoum oi the spore;CDC ?neassemd;
OHHS orG declined to uoto entity upto 

 

 

 

shipments:

- USAMKIID sends DPG believes is inactivated CDC subsequent?
adds vet to select agent 

- DPG-LSD shippedVEE as inactivated lo ECBC, Armed forces Institute of Pathology
(AFIPI, and You private companies

- CDC about VEE status; (DC response lslhat lt lsup to DPG-LSD to
ensure the VEE rs wmpletew i nactivated

- 0P6 LSD asks USAMRIID about the Inactivation with lnconduswe resuIs.

- CDC lrwe stigatlon ol and lndudeswhether VEE was impropeer
CDC investigation resiltspendln;

 

 

zotsoa I
201500 096450 notlfiesCDCofthecontamination I
201508 DPG-ISD I

 

 

 

 

20150) I
20150! identitieslnootrectlotnumbers I
201409 DPG-lSDsends Vacunovialsrouswc I

 

 

 

 

[201401 sends mislabeled Inactivateda. onrhrocis and [penis vials to Republlcol Korea I

 

 

201103 new labeland certilicatelromDPG-ISD I
20110] mismatdtedlabelsandcemilcate I

 

 

 

201012 DPG?lSDsendsB. iouswc 

h-dlnbolvscertittcate I

 

 

201007 NSWCauloclavesthe VEE

 

201007 I

 

 

201007 DPG-LSD ships inactivated we to NSWC instead of requested
inactivated Bantams (DPG switched shipments with another companyi

 

 

 

 

I 201111 OHHS OlGelects not to impose WWJ
201106 I
LZOHDS I
I 201104 NWC 
malt shios?otulinumtoxintoNM?C 
201010 scat 

 

 

 

 

 

 

I 200002 Botullnum toxin to mac I

 

 

I 200912 Dims OIG elects not to impose.? civil monetarypenalty I

 

on I



 

I M70505 I

 

I 100704 

 

200703 DPG lnactivates spores with CIOZ: 40' 5 vialstnoyowthl
issued death cemllcates

 

 

 

 

I 201503 (?investigation statuses select agent I

 

 

201302 aboutVEEinactlvationstotus I

 

L200702 shipsVEEto and one private company I

 

201203 I

I

 

201009 I

 

I 200503 

 



 

21103-04 ships Vi!
to 
believa it lobe inactivated

 

 

123

 

 

Appendix B: Dugway Proving Ground Organizational Charts

 

     

 

FOUO

23 July 2015

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ILSJIBMY

 

 

 

 

 

 

'rmm lvuuw'

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Division Deiuti I

 

 

 

 

 

 

 

Life Sciences
Division

 

 

 

 

 

 

 

 

 

 

 

    
  

 

Govemment

(5)

 

 

 

 

 

Jacobs Suiort
Actini Jacobs Manalement

 

 

 



Government

(5)

 

    

 

Jacobs Ol't

Appendix C: Army Biological Laboratory Funding Pro?les

This section provides a detailed breakdown of the funding pro?les for the three US. Army
laboratories involved in work with biological select agents and toxins. These details were
investigated in order to assess the validity of claims that the laboratories are in direct competition
for funding and to determine how the competition, or lack thereof, affects operations and
working environments at the labomtories. The 15-6 investigation team ultimately concluded that
the claims made by that competition for funding was adversely affecting
operations at DPG-LSD were unfounded.

Life Sciences Division, West Desert Test Center, Dugway Proving Ground

The DPG-LSD total budget was about $5,714,000 balanced between centrally
provided non-reimbursable funds and reimbursable customer funds. Figure 40 shows that about
half the FY14 RDTE funds were non-reimbursable dollars fr0m the Major Range and Test
Facility Base defense-wide funding line. These dollars provided operating funds to
DPG-LSD to ensure that DOD test customers were only charged the direct costs of testing, and
that the overhead costs were centrally funded.509

Reimbursable funding to DPG-LSD from customers covered the remaining half of the annual
costs (Figure 40). A majority of the reimbursable funding for DPG-LSD came from the Joint
Program Executive Office for Chemical and Biological Defense for projects including (1) the
production of reagents for the CRP, and (2) test and evaluation for the Joint USFK (United States
Forces Korea) Portal and Integrated Threat Recognition (JUPITR), the Joint Biological Tactical
Detection System (J BTDS), and the Next Generation Diagnostic System (NGDS) programs. The
remaining reimbursable funds covered the certification cost of the new Dugway Whole System
Live Agent Testing (WSLAT) chamber and support to academia, industry, other services and
foreign customers for testing and evaluation.?0

 

50" See Tab E-18, Funding Pro?le.
530 Id.

126

 

 

FY2014 Total Obligation Authority 55, 714,000

 

 

 

Academia and
Industry Non-Federal
6% 1%

Federal support
to WSLAT
6%

     
 

Non-reimbursable:
Defense-Wide

CRP
19%

 

If 
50%

Other JPEO-CBD .

5%
JPEO-CBD NGDS JPEOQD .

3% JPEGCBD CBDP Challenge

3% 1%
5%

 

 

 

Figure 40: Funding Pro?le for the Life Sciences Division
Biosciences Division, Edgewood Chemical Biological Center

In Fiscal Year 2014, the Biosciences Division at ECBC received about $25,103,000 for
biological defense support (Figure 41). Nearly all of the FY14 funds were reimbursable dollars
split between the Defense Threat Reduction Agency and Joint Program Executive Of?ce for
Chemical and Biological Defense. The Joint Science and Technology Of?ce at Defense Threat
Reduction Agency (DTRA STD) provided funding for various research projects, including
Biological Intelligence, Reconnaissance, and Surveillance The Joint Program
Executive Of?ce for Chemical and Biological Defense (J PEO-CBD) provided funding for the
CRP, focused on limited production of genomic materials. The Joint Program Executive Office
for Chemical and Biological Defense also funded research, deveIOpment and prototyping of
programs including the Joint USF (United States Forces Korea) Portal and Integrated Threat
Recognition (J the Next Generation Diagnostic System (NGDS), Biological
Interoperability Capability Sets (BICS) and a sensing system known as Luminex Mag. A small
amount of funding came from academia and industry??

 

5? See Tab E?l9, ECBC Funding Pro?le.
127

 

 

FY 2014 Total Obligation Authority - $25,103,000

 

 

 

CRP
2% JPEO-CBD BICS Academia and
9% Industry
0%

JPEO-CBD NGDS
1%

JUPITR
20%

JPEO-CBD Luminex
Mag
12%

   
 
  

DTRA JSTO
44%

    
 
   
     
    

DTRA Bio 13?!
12%

  

 

 

 

Figure 41: Funding Pro?le for the Biosciences Division at CBC

Science Directorate, US. Army Medical Research Institute of Infectious Diseases

In Fiscal Year 2014, the Science Directorate, USAMRIID received $102,500,000, split about
evenly between non-reimbursable and reimbursable funds (Figure 42). Approximately 56
percent of the total funding was non-reimbursable from the Defense Health Program and the
Department of the Army and was used for basic research and capability upgrades.512

The remaining 44 percent of the funding was reimbursable for medical and clinical direct
program costs. The Joint Program Executive Of?ce for Chemical and Biological Defense
(J PEO-CBD) provided funding for the CRP Unified Culture Collection and for Medical
Counterrneasure Systems (JPEO-CBD MCS). In addition, the Defense Threat Reduction
Agency Cooperative Biological Engagement Program (DRTA CBEP) and the Military Vaccine
Agency (MILVAX) each provided funding that helped make up the 44 percent of total
reimbursable funding. The remaining reimbursable funding supported other federal agencies
such as the Department of Health and Human Services, academia and industry/.5?

 

5?2 See Tab E-ZO, USAMRIID Funding Pro?le.
513 

128

 

 

FY 2014 Total Obligation Authority - $102,500,000

 

 

 

Academia and
Industry
Other Federal 495
DHHS 3%

1%

JPEO-CBD CRP
3%

  
  

 
 



24% Non-reimbursable:

Defense-Wide and

Army RDTE
5696
DTRA CBEP

6%

 
     
    
  
  

MILVAX
3%

 

 

 

Figure 42: Funding Profile for the Science Directorate, US. Army Medical Research Institute
of In fectious Diseases

Extent of competition:

While there may be a perception of competition with other Army laboratories among some
members of the DPG-LSD workforce, the 15-6 investigation team?s research into the funding for
all three laboratories yielded no data to support the conclusion that there is true competition. In
2014, programs from the Joint Program Executive Office for Chemical Biological Defense
funded all three ofthe Army labs, but their work was mostly complementary and not in direct
competition (Figure 423). Most of the customer overlap occurred between DPG-LSD and
Biosciences Division at ECBC, but the two labs supported different phases of larger program
efforts. For example, the Biosciences Division conducted research and developed prototypes for
the Joint USFK (United States Forces Korea) Portal and Integrated Threat Recognition (J UPITR)
program while DPG-LSD tested the capabilities of the new systems. Traditionally, the DOD
biological defense community provides reimbursable funding to the DPG-LSD for testing and
evaluation, while steering science and technology efforts to the Biosciences Division at ECBC.
The Science Directorate at USAMRIID has been the DOD medical and clinical focal point. The
15-6 investigation team determined that the CRP divided their of FY14 program funding
between the three Army labs based on their historical competencies and expertise.

129

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Life Sciences Dizision, Biosciences Division, Science Directorate,
Dugway Proving Ground Edgeu'ood Chemical US Army h?Iedical
Biological Center Research minute of
Customer Infectious Diseases
Defense Threat Reduction -
es es
Agency
Joint Program Executit'e
Of?ce for Chemical and Yes Yes Yes
Biological Defense
- JPEO-CBD Medical 
?r es
Countermeasure Systems
- Yes Yes
- IPEO-CBD Next
Generation Diagnostic Yes Yes
System
- IPEO-CBD Joint
Biological Tactical Yes Yes
Detection System
- JFEO-CBD Critical Yes Yes Yes
Reagent Program
- JPEO-CBD Loraine: Yes
Mag
- Biological
Interoperability Yes
Capability Sets
Military Vaccine  Yes
Department of Health and - .
Human Services e5 YES
Department of Homeland 
es
Security
Department of Energy Yes
Other Federal Agencies Yes
Academia and Indusuy Yes Yes

 

 

 

 

Figure 43: Comparison of Customers

130

 

Appendix D: Acronyms

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 --Acronym - De?nition
ATEC US. Army Test and Evaluation Command
CDC Centers for Disease Control and Prevention
CFR Code of Federal Regulations
CRP Critical Reagents Program
CRPAR Critical Reagents Program Antigen Repository
DAIG Department of the Army Inspector General
DHHS Department of Health and Human Services
DHHS-OIG Department of Health and Human Services, Of?ce of Inspector General
Department of Defense
DNA Deoxyribonucleic Acid
DPG Dugway Proving Ground
DPG-LSD Dugway Proving Ground Life Sciences Division
ECBC Edgewood Chemical and Biological Center
LLNL Lawrence Liverrnore National Laboratory
NMRC Naval Medical Research Center
NSWC Naval Surface Warfare Center
OSD Office of the Secretary of Defense
RNA Ribonucleic Acid Transfer RNA)
RSI Regulatory Science and Innovation Branch (at DPG-LSD)
US. Army Medical Research Institute of Infectious Diseases

 

USAMRIID

131

 

Appendix E: Glossary

 

 

 

 

 

 

 

 

Term I De?nition

Aerobic An aerobic organism can survive and grow in an oxygenated environment.
A culture medium having an agar (gelatin-like) base. This report references

Agar soy agar, which is a general purpose media that provides enough
nutrients for microorganisms to grow.

Amerithrax The FBI case name for the 2001 anthrax mail attacks.

Analyte A substance of interest in an analytical procedure (such as an assay)

Antigen A substance that causes an immune system to produce antibodies against it.

Assay An investigative procedure for qualitatively assessing or quantitatively measuring
the presence or amount of an entity (analyte).

Attenuate To reduce the virulence of a pathogen but still keep it viable (live).

 

Bacillus anthracfs

A bacterium that is the causative agent of the disease anthrax.

 

Biological Select Agent

The US. government?s term for viruses, bacteria and toxins with the potential to be
used as bioweapons or posing signi?cant risk to agriculture or public health.

 

Botulinum Neurotoxin A

A bacterium that is the causative agent of the disease botulism.

 

Burkholderia mallei

A bacterium that is the causative agent of the disease Glanders.

 

Causative Agent

A biological pathogen, such as a bacterium, virus, parasite or fungus, that causes a
disease.

 

Death Certi?cate

A document used at to certify and track the death/inactivation of
biological materials.

 

Dormant Spore Form

A state of existence where a cell is incapable of replication or enzymatic activity
but is signi?cantly more resistant to harsh environmental conditions.

 

Gram Stain

A method of differentiating between bacterial species into two large groups (gram-
negative and gram?positive).

 

Gray

A unit of measure of radiation equal to the absorption of one joule of energy per
one kilogram of matter.

 

Hydroxyl Radical

The neutral form of the hydroxide ion.

 

Lateral Flow Immunoassay

A simple device used to detect the presence of an analyte. The home pregnancy
test is a common example.

 

Mishap

For purposes of this report, a mishap is a mistake and is not synonymous with the
formal de?nition provided in Army safety regulations.

 

Non-Communicable

A condition or disease that is not infectious or not transmissible.

 

Non-Hemolytic

A substance that does not cause hemolysis (the breaking down of red blood cells).

 

 

 

 

Non?Motile A spore or other microorganism that is not capable of movement.
Overlap Select Agent A select agent that affects both humans and agriculture.
Pathogenicity The potential of certain microorganisms to cause disease.
A small, circular, double-stranded DNA molecule that is distinct from the cell?s
Plasmid chromosomal DNA. Plasmids carry genes that can provide bacteria with genetic

advantages (for example, antibiotic resistance) that can render them more harmful
or more di?icult to treat.

 

Polymerase Chain Reaction

A technology used in molecular biology to amplify DNA copies across several
orders of magnitude.

 

 

Reagent

 

A substance that is added to a system to cause a chemical reaction or to see if a
chemical reaction occurs.

 

132

 

 

Strain

A genetic variant or sub-type of a microorganism.

 

Vaccinia

A large, complex virus belonging to the poxvirus family. The active constituent of
the vaccine that eradicated smallpox.

 

Vegetative Cells

Any of the cells in a plant or animal that are not reproductive cells.

 

Venezuelan Equine Encephalitis

A mosquito borne viral pathogen that can infect all equine species and humans.
(VEE)

 

The ability of a living thing to maintain itself. For the purposes of this report,

 

 

 

 

Vlable viable is synonymous with ?live?.
Virulence The degree of pathogenicity of a microorganism.
Yersim'a 1983113 A bacterium that is the causative agent of the disease plague.

 

133

 

Appendix F: Timeline

29 JUL 2015:
- Appointment orders signed by the Director of the Army Staff and sent to Major General
Ostrowski and The Office of The Judge Advocate General.

30 JUL 2015:
- Legal adviser met with Major General Ostrowski and provided him with an initial brief on
the investigation.
- The legal adviser sent Major General Ostrowski and Assistant Investigator (6) ail
of the information he collected on the case via 6 email messages.

31 JUL 2015:
- Major General Ostrowski held a teleconference with his assistant investigators (6)
legal adviser, and Mr. Carmen Spencer. The group was briefed by
Mr. Spencer (Program Executive Of?cer for the Joint Program Executive Office for
Chemical and Biological Defense) en the historical facts of the case.
Major General Ostrowski held a face to face meeting with Mr. Spencer. Also in attendance
were (6) and legal adviser. On the conference cail was  The
investigative team received a detailed brief from Mr. Spencer.
- 1600 phone call with MEDCOM Commander.

3 AUG 2015: (the investigator was TDY 3-7 AUG 20l 5)
- 0800 Partial investigative team met to discuss the theory of the case and investigative plan.

 
  

(5) (6) . (6) (JPEO-CBD), and legal adviser, (6) . (NRMC
BIO Safety), (6) BIO Surety))

- 0930 phone call with investigator - discussed the investigation and information gathering.
- 1300 phone call with investigator discussed the investigation and information gathering.
- 1600 phone call with investigator discussed the investigation and information gathering.

4 AUG 2015:
- 0800 Partial investigative met and was assigned Specific tasks based on their area of
expertise.
- Phone call with investigator discussed the investigation, information gathering, and
received further focus areas for analysis.
- (6) Microbiologist) joined the investigative team.
- 1300 (6) and meet with Dr. Vahid Majidi (DASD-NM).
- 1600 Partial investigative team met for the day?s update meeting.

- (6) 1 met with Dr. Chris Hassel (DASD-CBD) and (6) .

5 AUG 2015:
- 0800 Partial investigative team met (6) was on the phone).
- The team broke to work on their respective focus areas.

- 1030 Investigative team met to discuss how the research re ressin what RFIs to DPG
were needed, and to the teem.

I34

 
  
 

 Worked on the document control plan, automation, and the taking of sworn statements.
Request paralegal support-

- Looking into requesting email messages

- updated the witness list.

6 AUG 2015:
- 0800 Partial investigative team met and discussed the investigative plan and the need for an

extension.
- Additional legal advisor was assigned, (6)
- 0930 phone call with investigator. The investigative team provided him with an update

brief.

joined the team to be the administrative support of?cer.
- Deadline extension request and investigative team memorandum for record drafted.
- 1600 closeout meeting

7 AUG 2015:
- 0800 Morning Huddle
- 0930 phone call with investigator. The investigative team provided him with an update
brief.
- Team broke out to research, revise methodology and problem statement. Prepared brie?ng
documents for Director of the Army Staff update on Monday, IO AUG 2015.
- Assistant lOs prepared for and conducted an interview with (6)

10 AUG 2015:
- 0830 Morning Huddle.
Scrubbed Director ofthe Army Staff update brief.
Discussed the extension memo request.
Discussed development of an Interview plan and the that need to be sent to DPG.
- 1430 interview with Dr. Majidi. 
- I645 Director ofthe Army Staff update.

11 AUG 2015:
- Investigative team traveled to for a tour of the facility and discussions with key
personnel at the facility.
- Interviewed approximately six people.

12 AUG 2015:
- Investigative team traveled to ECBC for a tour of the facility and discussions with key
personnel at the facility.
- Interviewed approximately three people.

13 AUG 2015:
- Team prepared to interview approximately 22 personnel at DPG.
- Developed standardized and speci?c questions for relevant DPG personnel.

14 AUG 2015:
- Team prepared to interview approximately 22 personnel at DPG.

- Developed standardized and eci?c uestions for relevant DPG personnel.
- Phone interview with nah

16 AUG 2015:
- Investigative team traveled to DPG and continued preparation for interviews.

 

17 ?21 AUG 2015: DPG Site Visit.
- Investigative team received an in-brief and tour of DPG-LSD.
- Investigative team conducted interviews with 28 personnel from DPG.
- investigative team gathered documentary evidence.

- Investigative team assisted DPG in conducting environmental sampling of Biosafety Level-
2 and 3 labs.

24 AUG 2015:
- Morning huddle reviewed [05 notes on the draft report.
- Finalized slides for the Director of the Army StaiT update on 25 AUG.
- Developed list of additional personnel to be interviewed. Prepared a list of relevant
questions for each.
- Team continued reviewing the documentary evidence collected at DPG.

25 AUG 2015:
- 0800 Director of the Army Staff update.
- 0840 Morning huddle reviewed investigator?s notes on the draft report.
- The team worked on organizing all documentary evidence.
- Personnel worked on dra?ing an outline of the relevant topics that must be included in the
report of investigation (with sub headings).
- 1615 Interviewed MG Karbler, ATEC Commander (June 2015 to present).

26 AUG 2015:
- 0800 Morning huddle discussed the draft outline for the report of investigation.
- Team continued organizing all documentary evidence.
- Personnel worked on finalizing the outline with sub headings and t0pics.
- Team began another review of the evidence collected.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.

27 AUG 2015:
0700 Interview with MG Utley, former ATEC Commander (2013 2015).
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- I330 Follow-up interview with (2013-2015).
- Team continued organizing all documentary evidence.
- Personnel worked on drafting the report.
- Team began another review of the evidence collected.
- 1600 Evening huddle - reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

I36

28 AUG 2015:
- 0800 Morning huddle the investigative team discussed the draft report.
Team continued organizing ali documentary evidence.
- Personnel worked on drafting the report.
- Team began another review of the evidence collected.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

31 AUG 2015:
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- 1130 Interview with Mr. Jimenez, Deputy to the Commanding General of ATEC (JAN
2015 to present).
- Interview with
- 1500 Interview with BG King.
- 1600 Evening huddle reviewed 105 notes on the draft report.
- Prepared a dra? report for the investigator to read overnight.

1 SEP 2015:
- No Morning huddle.
- Team assisted in responding to congressional inquiry resulting from CDC subsequent
Inspection at DPG.
- 0940 Phone call with (6)
- 1600 Evening huddle reviewed 105 notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

2 SEP 2015:
- 0800 Morning huddle.
- Continued support to congressional inquiry.
1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

3 Sep 2015:
- 0800 Morning huddle.
- Continued support to congressional inquiry.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a drait report for the investigator to read overnight.

4 Sep 2015:
- 0800 Morning huddle.
- Continued support to congressional inquiry.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

I37

8 SEP 2015:
- 0800 Morning huddle reviewed investigator?s notes on the dra? re ort.
- Conducted a follow-up interview and statement MM
- inalized MG Utley?s statement.
- Interviewed (6)

- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a dra? report for the investigator to read overnight.

9 SEP 2015:

- 0800 Morning huddle reviewed investi ator?s notes on the draft re on.

- Finalized the following statements:_
- Worked on revising the report of investigation.

- Followed-up with DPG-LSD on CCTV videos.

1600 Evening huddle reviewed investigator?s notes on the dra? report.

- Prepared a draft report for the investigator to read overnight.

10 SEP 2015:
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- Coordinated Red Team Travel.
-- Phone interview wit (5)
- I600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a dra? report for the investigator to read overnight.

11 SEP 2015:
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- Finalized Red Team members.

- Director of the Army Staff status update on the progress of the investigation.

- I600 Evening huddle reviewed lnvestigator?s notes on the draft report.
Prepared a dra? report for the investigator to read overnight.

14 SEP 2015:
A 0900 Attended Army huddle on safety review and moratorium.
- Morning huddle reviewed investigator?s notes on the draft report.

- Worked on revising the report of investigation. Revised section on Bio lab funding.

Coordinated Red Team Travel.
- I600 Evening huddle reviewed investigator?s notes on the draft report.
Prepared a dra? report for the investigator to read overnight.

15 SEP 2015:
0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- Coordinated Red Team Travel. 
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

138

16 SEP 2015:
0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report ofinvestigation.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

17 SEP 2015:
0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report ofinvestigation.
- Coordinated Red Team Travel.
- 1600 Evening. huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

18 SEP 2015:
0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report ofinvestigation.
- Finalized Red Team Travel.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

21 SEP 2015:
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- Received evidence of 2004 quality audit.
1200 Red Team began the review ofthe ROI.
- 1300 Update to the Director ofthe Army Staff.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

22 SEP 2015:
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- 1400 Received feedback from Red Team on the Background section.
- Suggested implementing a process chart for Lot 1667.
- Suggested creating a glossary/de?nitions section.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

23 SEP 2015:
0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report ofinvestigation.
- Received feedback from Red Team on the Findings section.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

139

24 SEP 2015:
- 0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- Interview with (6)
- Follow~up interview with BG King. Sent BG King additional questions.
- Received feedback from Red Team on the recommendations section and revisions that were
implemented based on previous recommendations.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

25 SEP 2015:
0800 Morning huddle reviewed investigator?s notes on the draft report.
- Worked on revising the report of investigation.
- 1600 Evening huddle reviewed investigator?s notes on the draft report.
- Prepared a draft report for the investigator to read overnight.

28 SEP 2 OCT 2015:
- Investigative team reviewed the entire draft report for final edits.
- Investigative team reviewed the footnotes and fact checked the document.
Prepared a dra? report for the investigator to read overnight.

5 7 OCT 2015:
- Reviewed investigator?s notes on the draft report.
- Investigative team reviewed the entire draft report for ?nal edits.
- Investigative team reviewed the footnotes and fact checked the document.
Prepared a dra? report for the investigator to read overnight.

8 OCT 2015:
- Investigative team reviewed the entire draft report and made ?nal edits.

9 OCT 2015:
- Tumed in report and evidence to The Of?ce of the Judge Advocate General for a legal
review.

22 OCT 2015:
- The Of?ce of the Judge Advocate General directed the investigation team address speci?c
comments and questions requiring additional investigation and ?ndings.

23 OCT 2015:
- 0800 Morning huddle Investigative team worked on a way ahead, an additional witness
list, and started contacting witnesses.
- Pursuant to AR 204, The Inspector General authorized the investigating of?cer to
investigate senior army of?cials.

26 OCT 2015:
- 0800 Morning huddle developed an interview plan and drafted an extension request.

I40

- Interview with JUN 2011 JUN 2013).
- Interview wit JUN 2004 JUN 2007).
- Interview with Roger Nadeau (ATEC CDR JUN 2007 - MAR 2010).

  

27 OCT 2015:
0800 Morning huddle.
- The investigating o?icer requested and the Director of the Army Staff approved a second
60 day extension.
- Additionally, the Director of the Army Staff approved the investigating officer?s request for
an investigator ?om Department of the Army Inspector General?s Office to assist the team.

- Interview with MG Genaro DeIIarocco ATEC CDR OCT 2010 JUL 2013 .
- Interview with_

- Interview with (5)

28 OCT 2015:
- 0800 Morning huddle.
- Interview with - 2005 JUN 2007).
- Interview with Dr. Streilein (AT EC Executive Director MAR OCT 2010).
- Interview with James Myles (ATEC CDR MAY 2004 JUN 2007).

- Interview with JUN 2002 JUL 2005).

29 OCT 2015:
- 0800 Morning huddle.
- Interview with Robert E. Armbruster (ATEC CDR JUN 2002 MAY 2004).

- interview with - - FEB 2008 - Present).

30 OCT 2015:
- 0800 Morning huddle.
- Interview with (6)
- Researched contact information for DT personnel.

4 NOV 2015:
- Interview with Mr. Michael Etzinger (DTC Executive Director MAY DEC 2010).
- Interview with Mr. James Johnson (DTC Executive Director JUL 2008 MAY 2010).
- Interview with Del Turner (DTC CDR AUG 2006 OCT 201 I).
- Interview with Keith McNamara (DTC CDR NOV 2008 MAY 2004).

5 NOV 2015:
- 0800 Morning huddle.
- Interview wit - JAN 201 I Present).
- Interview with Michael Combest (DTC CDR OCT 2004 AUG 2006).

- Interview with - JUN 2002 MAY 2004).

6 NOV 2015:
- 0800 Morning huddle.

- interview with - -APR 2000 JAN 2015).

141

9 NOV 2015:
- 0800 Morning huddle.
- Team worked on revising the report and transcribing statements.

10 NOV 2015:
- 0800 Morning huddle.
- Follow-up interview with (6)

Follow-up interview with 80 William King.

12 NOV 2015:

- 0800 Morning huddle.
- Follow-up with (6)
- Interview with 
- Interview with (5) (5)
- Interview with (6)
- Follow-up Interview with?g[_

- Interview with

13 NOV 2015:
- 0800 Morning huddle.
- Examined Evidence.
- Interviewed (5)
- Dra? ?nal report of investigation.

   
 
 

APR 2000 JAN 2015).

16?20 NOV 2015:
- Examined Evidence.
- Draft ?nal report of investigation.

23 NOV 2015:
0800 Morning huddle.
- Final review and report editing.
- Submitted report to OTJAG and OGC at 1700.

3-15 DEC 2015:
- Reviewed and incorporated OTJ AG and OGC recommended changes.

142

Appendix G: Evidence

Evidence is provided digitally and in hard copy. The evidence is organized in 5 Tabs:

Tab A: Administrative Documents

 

 

 

 

 

 

 

 

 

 

 

 

Document Notes

1 SECARMY Directive 30 July 2015 Memo from SECARMY to
DAS appointing a 15?6 10

2 156 Appointment Memo from DAS Memo from DAS to MG Ostrowski
appointing him as 15-6 10

3 investigation Team Assignment Memo MFR formalizing the assignment ofthe 15-6
investigative team

4 60 Day Extension Request First request for 60 day extension

5 60 Day Extension Approval First approval of 60 day extension

6 Authorization to Inv. Senior Of?cials 23 October 2015 Memo from DAIG
authorizing MG Ostrowski to investigate
senior of?cials

7 2nd 60 Day Extension Request Second request for 60 day extension

8 2nd 60 Day Extension Approval Second approvai of 60 day extension

 

 

143

Tab B: Sworn Statements

Witness



I-II-I
I-IG


<3:an:sz

19
20 Jimenez, David
21
22 Karbler, Daniel
23 King, William
Witness

Utley, Peter

Estes, Allen
Tamilio, Douglas
Nadeau, R0

Dellarocco, Genaro

Streilein, James
Myles, James

Armbruster, Robert
Etzinger, Michael
Johnson, James
Turner, Frank (Del)
McNamara, Keith
Com best, Michael
Wolf, Andrew

 

I44

Tab C: Documentary Evidence

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Document Notes

1 (Revs 0-8) DPG SOP for Inactivation and Sterility
Testing of Biological Agents (Revs 0-8;
12/01 to present)

2 (Revs 0-7) DPG SOP for Irradiator Operations (Revs
0-7; 2004-present)

3 WDL-GEN-04S (Rev 3) DPG SOP for Environmental
Sampling/Monitorinig (13 November
2014)

4 (Revs 0-5) DPG SOP for PCR (Polymerase Chain
Reaction) (Revs 0-7; 1/09 to present)

5 20 (Revs 0-12) DPG SOP for Shipment of Biological
Materials (Revs 0-12; 10/03 to present)

6 WDL-SAF-326 DPG Laboratory Safety Manual (Rev 9)

7 WDL-SAF-330 DPG ESL-3 Safety Guide (Rev 10; 9/14)

8 CRPAR Mgt. Proced. 003 and 007 CRP Antigen Repository Procedures Mgt.
Review Procedures, Uncertainties,
Environment Procedure

9 CPR Work Instructions CRP Antigen Repository Work
Instructions

10 2006 March - Lab Notebook (6) notebook #0205 (March
2006)

11 2007 October - Lab Notebook (6) notebook #0428 (October
2007)

12 2013 August Lab Notebook (6) . otebook #0530 (August
2013)

13 2013 September - Lab Notebook (6) notebook #0542 (September
2013) - includes Lot 1667 irradiation notes

14 Spore Concentration Table Table of initial spore concentrations for
various CRP lots of Ba

15 CRP Program - Info on Irradiated Lots Radiation info (SOP, dose, etc.) for all
CRP lots of Ba

16 Incident Report - Comp of Class Info MFR - Incident Report - Possible
Compromise of Classi?ed Information.
16 June 2015)

17 Memo - CRP SCG Violations Memo for DPG Commander - CRP
Violations of Security Classi?cation Guide
(18 June 2015)

18 CRP Security Classi?cation Guide CRP Security Classification Guide
(November 2005)

19 Lot 1667 Death Certi?cate Lot 1667 Death Certi?cate

20 Lot 1667 - Discrepant Death Certs Lot 1667 - three versions of Death

Certi?cate

 

145

 

 

21

Shipping Documents Korea Incident (2014)

"Kilier Organism" shipping documentation

 

22

(6) Email I (ODASAF)

(6) email - ODASAF no record
of historical DPG incidents (03 September
2015)

 

23

(6) Email 2 (ODASAF)

- (6) email - ODASAF no record
of current DPG incident (14 September

2015)

 

24

2004 Camber Audit

2004 Technical Audit of CRPAntigen
Repository by Camber Corporations

 

25

(6) Email (blind study details)

Email from (6) with details
about blinded study that led to current
discovery (31 August 2015)

 

26

FedEx Shipping Docs (8 Apr 2015)

Fedex shipping documentation for Lot
1667 to private entity in April 2015
(subject of investigation)

 

27

Task Force Anthrax - Daily Report #34

Task Force Anthrax daily report (01
October 2015)

 

28

20150915 Telecon with DPG Record

Memo to document telecon between 15-6
team and DPG personnel on 15 September
2015

 

29

20150720 - Karbler Memo (transfer CRP)

Memo from MG Karbler to the VCSA
requesting transfer of CRP mission from
DPG

 

30

(6) Email - ECBC Env Mon. Notice

 

Email from (6) - with

information about ECBCs Environmental
Sampling procedures

 

31

20150930 - Emails with DPG JAG

Emails from DPG JAG stating that there
are no records for investigations into
historical incidents

 

32

Solicitation No. W91 lQY-l 5-R-0018

Solicitation for the blinded study
associated with the May 2015 discovery of
viable Ba

 

33

DAIG 381 Report (2005)

DAIG Biosurety Inspection Report from
2005

 

34

DAIG BSI Reports (2007)

DAIG Biosurety Inspection Report from
2007

 

 

 

 

 

 

35 DAIG 881 Reports (2009) DAIG Biosurety Inspection Report ?om
36 DAIG 881 Reports (201 1)  Biosurety Inspection Report from
37 DAIG Reports (2013) 231116 Biosurety [nSpection Report from
38 DAIG 351 Reports (2015) 2D0180 Biosurety Inspection Report from
39 ISO Guide 34 Izg?scuide for Accreditation of Biological

 

 

Reference Material Producers

 

I46

 

 

 

 

 

40 ISO Guide 17025 [80 Guide for General Accreditation of
Biological Laboratories

41 LLNL Correspondence and Evidence Compiled correspondence and evidence
associated with the 2007-2010 LLNL Ba
incident

42 Bot A Correspondence and Evidence Compiled correspondence and evidence
associated with the 2008-2010 Bot A
shipments

43 Emails - VEE (20l 3)

Emails between (6) (USAMRIID)
and (6) regarding VEE

inactivation (March 20 3)

 

 

44

(6) Emails - VEE (2010)

Emails between (6) and
- (6) regarding VEE shipment

(September 2010)

 

 

45

(6) Emails - WEB (2015)

Emails from (6) regarding VEE
shipments/material disposition (September
2015)

 

46

201 1 15-6 Investigation Report

BG Smith's l5-6 investigation repOrt on
Chemical Accountability at DPG (February
201 l)

 

 

47 Email - (6) (2015 Blind study info) Email from (6) (ACC) with details
about the blinded stufy solicitation
48 Email - Daniel Karbler (VEE Shipments) Email from MG Karbler to the DAS with

information about VEE shipments

 

49

Spreadsheet with VEE Details

VEE tracking spreadsheet

 

50

HEPA Correspondence and Evidence

Compiled correSpondence and evidence
associated with the 20l5 HEPA ?lter
failure at 

 

 

51

 

DPG-LSD CDC Registration and RO-ARO
Designation

 

Document identifying CDC ReSponsible
Of?cial and Assistant Responsible
Of?cials at DPG-LSD

 

147

 

Tab D: Previous Investigations

 

 

 

 

 

 

 

 

 

 

 

 

 

Document Notes

1a 20150605 CDC Entity Insp Report on CDC inspection of DPG-LSD in
June 2015 (after discovery of viable Ba)

1b 20150724 CDC Civil Penalty Memo from CDC to DHHS 01G
recommended a civil monetary penalty for
current Ba issues

2 20150713 OSD Report July 2015 "Majidi" report

3a 20150730 SECARMY - ASAALT Memo Memo from SECARMY to 
directing a working group to assess the
?ndings ofthe Majidi report

3b 20150730 SECARMY - DSD Memo Memo from SECARMY to DEPSECDEF
with implementation plan

4a 20150826 CDC ReiHSpection Report on CDC re~inspection of DPG-LSD
after 15-6 team found contamination during
environmental sampling (26 August 2015)

4b 20i50828 CDC Suspension (Ba) CDC memo to suspending 
LSD registration to work with Ba (28 August
2015)

4c 20150831 CDC Suspension (ail) CDC memo to DPG-LSD suspending DPG-
LSD registration to work with all select
agents (31 August 2015)

4d 20151020 CDC Entity Inspection Report CDC memo to DPG-LSD containing the

detailed ?ndings ofthe 27?28 August 2015
re-inspection

 

148

 

Tab E: References

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Document Notes
1 AR 50?1 Biological Surety
2 AR 190-17 BSAT Security
3 AR 702-] 1 Army Quality Program
4 Baciilus Anthracis MSDS
5 BMBL Biosafety in Microbiological and
Biomedical Facilities
6 CDC - Biosafety Levels Information on various BSL levels
7 CDC - Revised Viability Testing Protocol Revised viability testing protocol
from the CDC based on new
(2015) ?ndings
8 2014071 1 CDC Report on Exposure to Anthrax
9 201 101 19 - CRPAR Corrective Action Report
10 201501 13 - CRPAR Corrective Action Report
11 DA PAM 385-69 Safety Standards for Bio Labs
12 ECBC Safety Brief
13 ECBC Safety Program Overview Brief
14 ECBC SOP - RSB 143 - ESL-3 Lab Operations
15 ECBC SOP - RSB 179 Ba Decon SOP
16 ECBC SOP - RSB 319- Production of Bacteria and
Viruses
17 FDA Current Good Manufacturing Practice
18 Funding Profiie - DPG LSD
19 Funding Pro?le - ECBC
20 Funding Profile - USAMRIID
21 20150724 - House Hearing on FSAP 24 July 2015 House Committee on
Energy and Commerce Hearing on
the Federal Select Agents Program
22 20150817 - BSAT Moratorium Clarification
23 NMRC SOP 1N50-05 - Autoclave Ops
24 NMRC SOP I Movement of Live
Cultures
25 NMRC SOP - 1N50-10 Sterility Purity Testing
26 NMRC SOP - Declaration of Sterility or Purity
27 NMRC SOP IRRAD 1.0 Gamma Irradiation
Inactivation of Ba
28 ECBC Proposal to Research Ba Inactivation Past proposal from ECBC to
investigate and standardize Ba
irradiation/inactivation variables
29 USAMRIID SOP DS-94-O9 Culture and ID of Ba
30 USAMRIID SOP DS-94-21 DuPont Qualicon

 

149

 

 

 

 

 

 

 

 

 

 

 

 

 

31 USAMRIID SOP - SA-02-15 Inactivation of Viral
Stocks
32 20] 50821 - CDC Notice of Inspection USAMRIID
33 Memo - - BA Questionnaire Information from SME about Ba
inactivation and resistance
properties
34 Memo -- BA Questionnaire Information from SME about Ba
inactivation and resistance
properties
35 CRP Overview Brief
36 20150610 - Brie?ng - Shipment of Inactivated
Ba
37 AR 20-1 (16 Activities and Procedures)
38 Email - King to (FBI Volume Email with information about the
Discrepancy Issue) 2009 FBI BSAT volume
discrepancy incident
39 CDC R0 Guidance Document Guidance document from CDC for
responsible of?cials
40 20151026 Memo - Executive Agent Delegation Memo from SECARMY to the

 

 

Surgeon General delegating
Executive Agent duties

 

150