June 11, 2015 Alison Young USA TODAY 7950 Jones Branch Drive McLean, Virginia 22108 Dear Ms. Young: This letter is in response to your Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry (CDC/ATSDR) Freedom of Information Act (FOIA) request of January 29, 2015, pertaining to the CDC Select Agent Program’s use of performance improvement plans or programs for select agent entities or research institutions from 2010 to the present. Enclosed is a CD containing documents (91 pages) responsive to your request. CDC has not withheld any pages in their entirety. CDC is redacting specific information in these 91 pages that concern the identities and locations of select agent registrants, as well as listed select agents or toxins under the authority of 5 U.S.C. §552(b)(3) and the Department’s implementing regulations at 45 CFR §5.64, as these records are specifically exempted from disclosure pursuant to FOIA by 42 U.S.C. §262a(h). You have the right to appeal this decision to deny you full access to agency records. Your appeal should be sent within 30 days from the date you receive this letter to the Deputy Agency Chief FOIA Officer, Office of the Assistant Secretary for Public Affairs, U.S. Department of Health and Human Services, Room 19-01, 5600 Fishers Lane, Rockville, MD 20857. Sincerely, Katherine Norris CDC/ATSDR FOIA Officer Office of the Chief Information Officer (770) 488-6399 Fax: (404) 235-1852 15-00358-FOIA i 13"" ?1 DEPARTMENT OF HEALTH AND, HUMAN SERVICES Public Health Service Centers for Disease Control eh i and Prevention (CDC) Atlanta GA 303416724 January 9, 2014 lbll3l?j42 2 Subiect: Opportunity to Show Cause why the Select Agent Registration - .. not be suspended or revoked 2 U.S.C. 2 lbll3l?fl2 8.0. 2 Section ?13.8 of the select agent regulations (42 C.F.R. 73.8) provides that an entity?s registration may be suspended or revoked for failure to nieet the requirements of the select agent regulations. SIC..- . . . . 115 bemg provided the opportunity to show why the. t?gi??tignmof I Ito possess, use! and transfer select and toxins should not be suspended or revoked. This action by the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins DSAT) is based on the observations noted during the November 5-7, 2013 impaction Speci?cally, DSAT has si ificant concerns regarding the administrative oversight of the USO. 2 U-S-C- 2 select toxins possessed and usednby, These concerns are detailed below. Observation provisions can be found in the Site Visit Inspection Report. II Failure to correct regulatory departures detailed in the November 12, 2010 DSAT facility insPection report for your entity. Seventeen of the thirty-nine regulatory departures observed during the December 11-12, 2012 inspection were repeated failures listed in the November 12, 2010 report. I Failure to correct regulatory departures detailed in the January 25, 2013 DSAT facility inspection report for your entity. As of thefdate of this letter, sixteen of the thirty-five regulatory departures observed during the November 5-2, 2013 inspection were repeated failures listed in the January 25, 2013 report. Failure to implement biosafety, security, and incident response plans. Specifically: In resPonse to the January 25, 2013 inspection report, facemask or face shield. must be worn when purifying or concentrating toxins in order to U-S-C- 2 control aerosols. However, CDC inspectors were informed during interviews conducted during the November 53-7, 2013 inspection that no respiratory protection had been usa- since the January 25, 2013 inspection. Further, inspectors observed during this inspection that neither the use of respirators nor facemasks nor face shields had beenW' implemented. Accession Number: 223547: Page: 3 Scan Date: 2014-01-14 COPY ?e 3 Page 2 of 4 for the following regulatory departures during the last 4 inspections; which: remained uncorrected at the time of the November 5-7 2013 inspection: - failure to review security, biosafety, and incident response plans; failure to conduct visitor training; and - I failure to account for the hazards of select toxins in I response plan . failed to implement the inventory log that was submitted as a response to the January 25, 2013 inspection report (December 11-12, 2012 in5pection) to verify that they had an accurate and current inventory. use. 2 Responsible Official (R0) to be familiar with the requirements of 42 CF 73, as required upder section and to ensure compliance with 42 CFR Part 73, as required under section Speci?cally 0 Based on the questions posed to the R0 by the inspection team, the R0 was unaware of the new requirements of 742 CFR Part 73 that became effective on December, 2012 and April, 2013; The R0 submitted 3 different security plans to the inapection team and was unsure which plan the entity followed at the time of the inspection; 0 The R0 was unaware of the information submitted in response to the January 25, 2013 -inspection?re;mrt (DecembeH-l-n, 201-2 inspection), and he could not locate the information; and The R0 was unaware of ,the policies, procedures, documents, and processes that the entity responded would be incorporated as a result of the January 25, 2013 inspection report (December 11?12, 2012 inspection). Accession Number: ensure the security of the select toxins at the facility as required by 42 CFR Part 73.11. Speci?cally: I lack of both key control procedures and adequate physical barriers could a non-SEA approved individual" access to the s'?l'ect toxin inventory. seldct toxin inventory are located in an unsecured drawer within a laboratory that does not have security barriers to prevent unauthorized access. During business hours, the door to the laboratory remains open, with only a chain across the entrance which would not impede access to select toxins. Failure to ensure that biosafety and containment procedures are suf?cient to contain the select toxin as required under 42 CFR Part Speci?cally, with the door to the laboratory open and without the use of respiratory protection, This document is intended for the exclusive use oi the 'recipientts} named above. It may contain sensitive information that is protected, privileged. or con?dential. and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientts), any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. 223547E Page: 4 Scan Date: 2014?01?14 COPY :4 2 Fac?lty Site v15?; .. at? 9 [Page 3 of4 (b)[3)242 I PerfOrms aerosol-generating experiments outside a biosafety cabinet with large U-S-C- quantities of toxin; and - 262am.) on the bencbtop' (b)(3)242 transports liquid toxin on carts without using leak-proof containers. .. uses a class cabinet in (b)[3)242 U.S.C. 262afh) 3 Based detailed in this letter, DSAT has signi?cant concerns: . regarding the complian'?'?tit -- with the requirements of 42 CFR Part 73. Syd-42 that does not eitereise administrative oversight of select toxin activities, and U.S.C. does not ensure compliance with all of the requirements of 42 CFR Part 73, as I re?luired under 42 CPR 42 DSAT recognizes that the current R0 hasfonly been in his position since November In lieu of taking steps to immediately begin proceedings to suspend or revoke thecerti?catgof- registration, DSAT is willing to allow i to participate in a Performancelmprovement 3 42 U30 Plan Program (PIPP) enumerated below. If desires to participate 262a(h) in days of the date of this letter, must: 262' I Ham) 1. Provide to DSAT a written performance improvement plan describing howwill resolve the outstanding departures specified in this letter as well as those identi?ed in the site visit inspection reports. The performance improvement plan must include milestones for resolution of the departures; 2. Implement the plan immediately upon approval by 3. Provide to DSAT bi-weekly progress reports detailing milestones completed; 4. Agree to notify DSAT immediately of any situation that impacts the plan; 5. Agree to resolve all departures identi?ed in the site visit inspection reports in accordance with the approved plan; andm?nw 6. Provide to DSAT written confirmations as departures are corrected. Shoulddecline to participate in the PIPP, all observations noted in the Site Visit ?inspection reports dated November 12, 2010, January 25, 2013, and January 2014 must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty calendar days of the receipt of this letter. DSAT inspects each registered facility to ensure that it meets the appropriate safety and security standards, as well as record-keeping requirements, found in 42 CFR Part 73. DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See 42 C.F.R. 73.18). Resolution of all departures will be confirmed by an onsite verification inspection by DSAT. This document is intended forthe exclusive use of the recipientts} named above. It may contain sensitive information that is protected. - - - - - privileged, or con?dential, and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. If or copying is strictly prohibited. If you think you have received this 'document' in error, please notify the sender immediately and destroy the original. Accession Number: 223547; Page: 5 Scan Date: 2014?01-14 COPY Page 4 of 4 If you have any questions concerning this correspondence, please contaotl Robbin Weyant, (ABSA) Captain, USPHS (Ret) Director, Division of Select Agents and Toxins Office Public Health Preparedness and Response Centers for Disease Controi and Prevention This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that is protected. privileged, or con?dential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientts}. any dissemination. distribution. or copying is strict1y prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the original. Accession Number: 223547: Page: 6 Scan Date: 2014?01-14 COPY b? 5'lef?'gllo r, a. - DEPARTMENTOE HEALTHAND-HUMANSEREICES . . r, Centers for Disease Control when til-Air cl I: and Prevention (CDC) Atlanta GA 303416724 use. 262a February 19, 2014 262a Subject: Opportunity to Show Agent Registration of I should not be suspended or 262a[h) Dear 2626101) . . .2923?? . (more Section 73.3 of the select agent regulations (42 C.F.R. 73.3)..ptovides that an entity?s registration may US be suspended or revoked for failure to meet the of the select agent regulations. Its opportunity to show why the registration ofl Itolbli3l342 possess, use, and transfer select agents and toxins should not be suspended or revoked. .51" (bli3l342 This action by the Centers for Disease Control andfrevention (CDC), Division of Select Agents and I, U-S-C- Toxins (DSAT) is based on the observations noted during the December 3-6, 2013 inspection 2523017" Specifically, the DSAT has significant concerns regarding the administrative oversight of the select agents and toxins possessed and used bl concams {bli3li42 are detailed below. Observation details citing specific regulatory provisions can be found in Inspection Report for the December 36, 2013 inspection, to be submitted under separate cover. 262nm) (bll3li42 lof select agents and toxins for whicbl [blu(3)242 2625100 is not registered in violation of Section Ito ensure that all select agents and toxins are stored and 2626101) 262a[h) manipulated in registered areas in violation of Section (b)(3)242 to restrict access to select agents to only individuals approved Federal Select Agent Program (ERA approved) to have such access in violation of 42 CFR 262a h) ?73.10. 0 Specifically: [b)[3)142 U130. 2628 (more confesses-zeta (more 262alh) person at the entity discovered 4 glass 262a[h) buildingl lis currently approved to possess however, the entity is not approved to possess has provided evidence that the aforementione vials were 2 Subsequently chemically inactivated and autoclaved; 262301) 252301) US: . 262a[h) Accession Number: 225874 Page: 3 Scan Date: 2014-02?20 COPY use. 262alh) Facility Site Visit Report:i I Page 2 of 6 (b)[3)242 U.S.C. 262alh) tartaric-use. ?a Sti?l?imb?ii?g'i'zmii 2' 252mm individual at the entity discovered 6 lvophilized cultures ofand 11 [he 2 (ma?a U-S-C- August 30, 2013. The entity is not approved to 262mm.-. .. has provided evidence that the aforementioneq a (b)(3)342 USO were subsequently autoclaved; 262alh) Inoti?ed DSAT that an SEA approved U-S-CI 2 (more use. a individual Ia USDA 3.1m 2626101) on Novembcr 8, 2013? during an inventory review Of the U.S.C. liquid nitrogen inventory database in unregistered zegarh) (W342 use. 2 -- Iinventory incidents detailed in the above by one $g3g42 Based on theNinto-rmtition received from the entity, there . . I (blt3li42 Inapecuonl?lhEDSAT lnspecmn team will ?labli the number of freazcrs WIthln land which-he?z?rs had bps? for inventory on uestions sad to I followingsh-e? @042 the responsible for 0' ~230-ft??ezers, refrigerators, and liquid nitrogen tan its. I I has not 2626101) conductedia?' audit of these freezers, refrigerators, and liquid nitrogen tanks ,0 def-?rming "additional?select agents and toxins are located in. unregistered space, or whethe It is 1n possessmn of additional select agents and toxins not listed on their registration. I 2625103) - Failure to correct all regulatory departures noted in thel I i?SpeClion reports U-S-O- 262st h) of the: 0 December 15-12, 2009 renewal inspection; 0 February 16?17, 2011 verification inspection; and U-S-C- 2625? November 27-29, 2012 renewal inspectionitems. detailed below represent the repeated failures 2626101) procedures, Irepresented to the DSAT that it would correct the regulatory departures noted in the reports for the 2009, 201], 2012, and 2013 DSAT 2623(h) inspections, as determined during the December 36, 2013 inspection. Specifically: Security (42 C.F.R. 73.11) (bli3l34 I failed to fully implement their written security plans which provide that entry into select agent and toxin laboratories is restricted to SEA approved 2626101) individuals or non?SRA approved individuals with an escort. during the 2011, 2012, and 2013 DSAT inspections, CDC inspectors observed on several occasions that entry into select agent and toxin laboratories had not been 3 42 restricted to SRA approved individuals or non-SEA approved individuals with an I escort. 262516) I ifailed to enforce the access control and monitoring measures that This document is intended for the exclusive use of the recipienils] named above it magir contain sensitive information that is protected. privileged. or confidential, and it sheurd not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientts}. any diSSEml?aliOn, distribution, or copying is chie?y; prohibited. If you think you have received this document in error, please omit}; the sender immediately and destroy the original. Accession Number: 225874 Page: 4 Scan Date: 2014?02?20 COPY 9? 0. to: no co Ire-presented to DSAT-arwould be taken..to.correct_regulatory., .. departures noted during the February 16-17, 2011 and the November 27?29, 2o12 DSAT inspections. Specifically: I during the December 3-6, 2013 inspection, inspectors were informed that a .. Ipersonnel who do not have SRA U-S-C- 25 approval have unrestricted card key access to registered space I I U516. 26 U-3 0- 26 andnseyensupervisors have master keys that override the card key access .. allowing them unrestricted access into registered Space. This same 26 observation had been cited in the 2011 and 2102 inspection reports, but remains uncorrected. Training (42 C.F.R. 73.15) failed to meet training requirements over the last four years. U.S.C. 26 Specifically:- I during the 2009 inspection, CDC inspectors observed that initial training on biosafety and security was not provided to each individual before he or she was allowed access to select agents and toxins; I during the 2009, 2011, 2012, and 2013 DSAT inspections, CDC inspectors observed that visitor training on biosafety and scourity was not provided to each individual before he or she was allowed to enter areas where select agents or toxins are handled or stored; in 2013, incident response training was not provided registered Space without training in U.S.C. 26 2011, 2012, and 2013. I during the 2011, 2012, and 2013 DSAT inspections, CDC inspectors observed that annual refresher training on biosafety and security was not provided to all SRA approved staff; in 2013, incident response training had also not been provided to SRA approved staff. Records (42 C.F.R. 73.1?) - (9)3242 Ihas failed to meet inventory record keeping requirements over U.S.C. 26 the last four years. Specifically: I during the 2009, 2011, 2012, and 2013 DSAT inspections, CDC inspectors observed that many inventory recording elements required under 42 C.F.R. ?73.17 for select agents and toxins were missing from Principle Investigators? (Pls?) inventory log sheets; during inventory audits conducted during the 2009 and 2012 DSAT inspections, (bxe?h?g .. .. linventory was not accurate and U-S-C- 26 Current. Specifically, during the 2009 inapection, CDC inspectors observed 1 Pl?s inventory log sheet failed to record the possession of 2 vials of in 2012, CDC inspectors observed USC. 26 26 1 Iwas mislabeled and there was a discrepancy with the quantity of select agent vials found in one of the boxes i. This document is intended for the exclusive use of the recipientts) named above. It may contain sensitive information that is protected. privileged. or confidential. and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. It you are not the intended reelpientts]. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the Miguel. Accession Number: 225874 Page: 5 Scan Date: 2014?02-20 COPY I .01 o. (-02 Biosafety (42 can 73.12) Page 4 of 6 [failed to provide entry. and .. toxin areas, as requested by inspectors during the 2012 and 2013 DSAT inspections. the entry records and did not provide them to the R0 or ARO during either the 2012 or 2013 inspection. I has failed to address safety issues over the course of the last four years. Specifically: I . I during the 2009, 2011, 2012 and 2013 DSAT inspections, there was no evidence provided that indicated all biosafety cabinets in registered select agent and toxin areas were certified annually; I during the 2009 and 2012 DSAT inspections, there was no evidence indicating that the Hepa-filters and Hepa-filter housing servicing the certi?ed; U-S-C- 2 I during the 2009, 2011, and 2012 DSAT inspections, one or more PIs did not have Biosafety Plan(s) commensurate with the risk of the select agent or toxin, given its intended use. Responsible Official (R0) does not have authority to act on behalf of the entity, as required under 42 CFR 73. 9 and to ensure compliance with the select agent regulations as required by 42 CFR 73.9 Speci?cally: Istaff during the December 3-6, 2013 DSAT inspection, they has the responsibility to is accountable for ensuring the compliance elect agent program with 42 CFR Part 73. However, it is the conclusion 2 the safety and security posture of thel the DSAT inspeCIors that IRO ultimately lacks the authority to shield? use. 2 select agent and toxin program. I For example, development and implementation of a suitability assessment program for individuals with access to Tier 1 select agents and toxins is a new regulatory requirement, effective April 4, 2013. As of the December 3-6, 2013 lhad failed to meet this requirement due to the pending approval from the Human Resources The RO indicated that this process could take years. U.S.C. 2 I As another example, based upon interviews conducted during the 2013 inspection, the R0 has not received the cooperation (0)9)142 facility-related and record-keeping issues. This failure has resulted in repeated U.S.C. 2 inspection observations over the last four years, as noted in earlier examples. The RO must seek the approval froml implementing critical changes necessary to ensure compliance with the select agent U.S.C. 2 regulations, and either the R0 has failed to inform leadership of his inability to effect This document is intended for the exclusive use of the reoipientisl named above. It may contain sensitive information that is protected, privileged. or con?dential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. it you are not the intended recipientis). any dissemination. distribution. or copying is Stricle prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the original_ Accession Number: 225874 Page: 6 Scan Date: 2014-02-20 COPY Facility Site Visit Report: 1' I I Page 5 0f 6 - -. echange over. people who donotreport .to has failed to. the, . issues identified by the R0. .. -- Ihas repeatedly submitted written plans (security, incident U-S-C- 2 response, and biosafety) that were not current. Plans submitted in response to observations from the 2012 inspection were dated as far back as 2004 and 2006, and the information supplied was not relevant to the request from DSAT. Plans submitted in response to requests for some PIs did not correspond to the work of those Pls, but were for -- I has repeatedly failed to develop 2 written plans that met the requirements of 42 CFR 73.11 (Security), 12 (Biosafety), and 14 (Incident Response); Further, the R0 has failed to en3ure that the P15 who do not report to him, but to a different organizational structure, have implemented their respective plans. 0 (bll3)?4 2 U.S.C. departures detailed in this letter, DSAT has significant concerns regarding the compliance of I I with the requirements of 42 CFR Part 73 in not exercise administrative oversight of select agent and toxin activities, and the R0 doesU.S.C_. 2 2 not ensure compliance with all of the requirements of 42 CFR Part 73. In lieu of taking steps to immediately begin proceedings to suspend or revoke the certificate of (bll3l342 to participate in a Performance U.S.CI Improvement Plan Program (PIPP) under the conditions enumerated below. Ifl desires to participate in the PLPP, within fourteen days of the date of the forthcoming inspection report, U_s_c_ 2 Imust: use. 2 b)t3)142 1. Provide DSAT with 2 I will ensure that the entity possession of any select agents or toxins that have not been included on the .. registration. 2 U.S.C. 2 b. a written plan for a complete inventory audit of all biological nitrogen tanks, refrigerators and freezers at II 2 c. a written Performance Improvement Plan (PIP) describing hove I I I will resolve the remaining regulatory departures Specified in the January 10, 2013 DSAT inspection report and all regulatory departures speci?ed in the February, 2014 DSAT inspection report, that you will receive under separate cover; i. The PIP must include a description of how thel ensure compliance with the requirements of 42 CFR Part 73; U-S-C- 2 ii. The PIP must Include milestones for resolution of regulatory departures; Implement the plan immediately upon approval by Provide to the DSAT bi-weekly progress reports detailing milestones completed; Agree to notify the DSAT immediately of any situation that impacts the plan; and Provide DSAT with written confirmations as departures are corrected. P"wa This document is intended for the exclusive use eithe recipientts] named above. It may contain sensitive information that is protested, privileged. or confidential, and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. it you are not the intended any dissemination, distribution, or copying is strictly prohibited. If you think you have resolved this document in error, please notify the sender immediately and destroy the original. Accession Number: 225874- Page: 7 Sean Date: 2014-02-20 COPY Accession Number: Page ISof? decline to participatein the . .. .. .. .. .. all observations noted in the DSAT inspection reports dated January 10, 2013 and February, 2014 must be resolved, and a written response documenting the completion ofan inventory audit of all biological agents and Imust be submitted to the DSAT in writing no later than thirty calendar days of the receipt the February, 2014 inspection report. DSAT inspects each registered facility to ensure that it meets the appropriate Safety and scourin standards, as well as record-keeping requirements, found in 42 CFR Part 73. DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations {See 42 CPR. 73.18). Resolution of all departures will be confirmed by an onsite verification inspection by DSAT., If you have any questions concerning this correspondence, please contactl Robbin Weyant, Captain, USPHS (Rec) Director, Division of Select Agents and Toxins Office Public Health Preparedness and Response Centers for Disoase Control and Prevention Cc: Cc: Cc; Cc: This document is intended lot the exclusive use of the recipientts} named above. It may contain sensitive informalton that is protected. privileged. or confidential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It you are not the intended recipientts}, any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error. please notily the sender Inunedtateiy and destroy the original. 225874 Page: 8 Scan Date: 2014?02?20 COPY ,e?me Department of Health and Human Services . US. Department of Agriculture A Centers for Disease Control and Prevention Animal and Plant Health Inspection Service 1. Division of Select Agents and Toxins _Agriculture Select Agent Services Atlanta, Georgia Riverdale. Maryland March 3, 2014 3mm Opportunity to Show Cause why the Select Agent Registration of Ishould not be suspended or revoked U-S-C- 2 sc. 2 if}. I I. Section 8 of the select agent and toxin regulations providos that 3" entitY'S registl'a?m may be suspended or revoked for failure to meet the requirements of the select agent and toxin regulations. 2 lb)(3)242 I is being provided the opportunity to show for C. the-possession, use, or transfer of select agents and toxins or revoked. meet the requirements of the select agent and toxin @gulations [42 CFR CFR Part 331 and 9 CFR Part 121 Specifically,? has a history of non-compliance with the select agent and toxin regulations which has been observed over our consecutive inspections conducted between January 2012 and December 2013 by representatives from the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services CDC and AP HIS the Federal Select Agent Program) have the following signi?cant to come into compliance with the requirements of the select agent and US .""?toxin regulations: has repeatedly failed to exercise administrative oversight of select agent activities. U-S-C- 2 The Responsible Of?cial (R0) fails to ensure compliance with all of the requirements of the select sent and toxin regulations. 2 has repeatedly failed to develop written biosafety plans its U-S-C- 2 registered select agents, given their intended use, whichusut?ciently"deecribe the biosafety and containment procedures required for all oa?pp'roved activities. has repeatedly failed to exercise operational and procedural safeguards suf?cient to ensure U.S.C. 2 biosatety and biocontainment of the select agents in its possession. has repeatedly failed to implement the provisions and procedures of its existing biosafety plans. U-S-C- 2 a has continuously failed to maintain complete records relating to its select agent activities including an accurate, current inventory with written explanations for any discrepancies. has continuoust failed to implement a system to ensure that all records are accurate and their 2 authenticity veri?ed. has continuously failed to provide appropriate training, failed to ensure its personnel understood such training as was provided. and failed to document the training claimed to have been performed. repeatedly failed to implement the requirements of its security plan to ensure that its select U.S.C. 2 - are safeguarded against unauthorized access, theft. loss. or release. Observations detailing the speci?c current departures from the requirements of the select agent and toxin regulations can be found in the inspection report from the December 3-6, 2013 inspection, submitted under separate cover from the Federal Select Agent Program; as well as in inspection reports issued 2 Accession NUmber: 226861 ,Page: 7 Scan Date: 2014?03-07 COPY the Federal Select Agent Program and dated April 2013 April 11, USC. April 10, 2013 (USDA-VS), October 11, 2012 (HHS), October 4, 2012 August 16, 2012 February 29, 2012 (USDA-VS), and February 23, 2012 (HH - summarize these departures, the following table denotes with an the major categories in'wl'li' requirements of the select agent and toxin regulations (refer to the Appendix for speci?c departures}. U.S.C. 2 January 2012 August 2012 February 2013 December 2013 Registration accuracy . it Security plan requirements Security plan Implementation! access control Biosafety plan requirements it it it Biosafety plan implementation] containment practices response plan requurements Training Record Maintenance )t Record Accuracy it R0 oversight it it operational structure, procedures for managing the use of its .. U-S-C- ??1d inventory management system have all proven to be ineffective in meeting the requirements 0 U.S.C. 2 agent and toxin regulations. gince 2011"; has expanded its select agent research program with the addition of new registered areas, repeatedly failed to develop and implement plans to address this scope of work. Furthermore was cited for signi?cant regulatory departures observed during the August 2012 select agent activities were not restricted to registered locations and agent was not restricted to security risk assessment-approved individuals. ?ased on subsequent observations made by Federal Select Aent Program inspectors in February and December 2013. it is our determination that the failure of (3)342 select agent and toxin regulations continues to be a systemic probiern unrelated to any one particular 2 Principal Investigator, location. or project. We do note that during each inspection, the Federal Select Agent Program inspectors observed that the Principal Investigators and facility support staff were very cooperative and eager to meet the reuirements of the select agent and toxin regulations. but had not been provided - leadership to enable them to do so. repeated failure to exercise administrative oversight of select agent activities conducted by the R0 and use": ?5 history of not ensuring compliance with all of the requirements of the select agent and toxin regulations have raised serious concerns regarding the ability procedural safeguards that are sufficient to ensure biosafety and biocontainment. and to ensure that 2 agents are safeguarded against unauthorized access, theft, loss or release. Our-signi?cant concerns regardin non-compliance with the select agent and toxin regulations were directly eadership by the Directors of the Federal Select Agent Program at U.S.C. 2 I Accession Number: 226861 Page: 8 Scan Date: 2014?03-07 COPY . . I I on June 14. 2013. On September 30, 2013, the Directors again met witt leadership in Iand expressed continuing concerns on the oversight of the select agent program. U.S.C. 2 U.S.C. 2 In lieu of taking steps to immediately suspend or revoke possession, use, or transfer of select agents and toxins, the Federal Select Agent Program is willing U-S-C- 2 enumerated below. management system and im to participate in a Performance improvement Plan Program under the must reevaluate its current operational structure, procedures for managing the use of facility for concurrent studies with different infectious agents, and its current inventory U.S.C. 2 ptement corrective actions necessary to ensure that continued departures in the regulatory requirements for the responsible of?cial, security, biosafety. training, and records do not occur. Within fourteen days of the date of this letter. Within fourteen days of the date of this letter, must notify the Federal Select Agent Program of must submit to the Federal Select Agent Program: a} A proposal of corrective actions that will be implemented to ensure that continued departures in the regulatory requirements forthe responsible of?cial, security. biosafety, training program, and records do not occur. wiltexercise administrative oversight, including oversight of those activities conducted by the R0, to ensure compliance with the select agent and toxin regulations. The proposal must speci?cally address the operational structure, policies and procedures used to activate and Inact select agent areas, select agent-speci?c training, inventory management and record- keeping systems. b} Provide a detailed summary of activities conducted in registered areas since December 7, 2013 through the date of this letter that describes'the agent used or stored {including strain designation], the location, purpose of use (including any animal studies) and area decontaminationldisinfection records, if applicable. and each Friday thereafter teen-tent,- must submit a weekly update beginning March 21, 2014, ntil conclusion of the PIPP agreement as follows: a) A description of activities conducted in registered areas including: 99?.?th 5. 6. 7 1. 2. Accession Number: 226861 the infectious agent used or stored (including strain designation}; the location in which the infectious agent is used or stored; the purpose of use; complete documentation of ail animal studies, including: the date the animal is introduced into registered rooms, the date of inoculation with the infectious agent, the date each animal is removed from the room, the state of the animal upon removal dead, moribund, the date the animal was necropsied, if applicable, the date the animal carcass andlor tissues are decontaminated; the method of decontamination; all registered space decontamination records, including: the room or area decontaminated. the disinfectant used and method of decontamination surface wash, gas decontamination). Page: 9 Scan Date: 2014-03-07 COPY b} Provide copies of all documents and communications used by the R0 or designee to: 7. As a condition of its PIPP agreement, by March 28. 2014, track the status containinginfectious agent,__not containing infectious agent) ofregisteredareas;and - - - - . .. regarding the status of any registered areas having contained infectious agents. a} Adequater address the departures noted for requirement #25 in the report from the December 3- 6, 2013 inspection provide written explanat ons for inventory discrepancies). including any additional discrepancies that may be identi?ed ti Representatives from the Federal Select Agent Program will conduct a site visit in April 2014 select agent inventory and inventory records: b) Provide a detailed update on the progress made towards resolving each of the departures noted in the report from the December 3-6, 2013 inspection, with the exception of the departure noted for requirement #25, which must be suf?ciently addressed as noted in above. As a condition of its agreement] by April 30' a) Have adequately addressed the following departures noted in the report from the December 3-6. 2013 inspection: . Requirement #1 Requirement #3 Requirement #4 Requirement #5 Requirement #6 Requirement Requirement #8 Requirement 9 Requirement #10 Requirement #11 Requirement #12 Requirement #13 Requirement #14 Requirement #15 Requirement #16 Requirement Requirement #13 Requirement #19 Requirement #20 Requirement #21 Requirement#22 Requirement #23 [Section Fih)] [Section 11{a)] [Section 11(b)] [Section [Section [Section [Section [Section [Section [Section 11(c)(10)] [Section [Section [Section . [Section [Section [Sections and [Section 12(a)] . [Sections 12(a) and 12(1)) [Section 12(e}] [Section 1403)] [Section 15(a)(1 [Section [Section 1503)] [Section 15(c)] [Section 15(d)] b) Provide a detailed update on the progress made towards resolving the following departures noted in the report from the December 3-6. 2013 inspection: Requirement #2 Requirement #9 Requirement #24 Requirement #26 [Section [Section 1.1 [Section [Section 1703)] As a condition of its PIPP agreement. by May 30, departures noted in the report from the December 36, 2013 inspection. use. 2 -Accession Number: 226861 Page: 10 Sean Date: 2014?03-07 COPY to participate in the PIPP, all departures noted in the report from the December 3-6, 2013 U.S.C. ?ir?spection must be resolved no later than thirty (30) days of the date of-this leter. Failure to fully respond to the departures may result in the initiation of proceedings for the withdrawal of. -- "use. or transfer select agents 2 Representatives from the Federal Select Agent Program will conduct a site visit in June 2014 to verify the rectify its history of non-compliance with the select agent and toxin Based on the June 2014 site visit, the Federal Select Agent Program will assess whether the 3 34 will be renewed to allow continued possession. use, or transfer of select agents and will be suspended. Please be reminded that the Federal Select Agent Program retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent reg ulations. if you have any questions concerning this correspondence. please contact Wichita Robbin S. Weyant, RBP (ABSA) Freeda E. isaac, DVM Captain. USPHS (Ret) . Director. Agriculture Select Agent Services Department of Health and Human Services United States Department of Agriculture Centers for Disease Control and Prevention Animal and Plant Health Inspection Service (blt3)i_420c 2 Cc: Cc: Accession Number: 226861 Page: 11 Scan-Date: 2014?03?07 COPY illiltrla l? DEPARTMENT OF HEALTH AND MN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30341-3724 May 12, 2014 Subject: Opportunity to Show Ca use why the Select Agent Registration of the 1342 should not be suspended or revoked U.S.C. 2 Section 7'13 ofthe select agent regulations (42 CPR. T18) provides that an entity?s registration may be suspended or revoked for failure to meet the requirements of the select agent regulations. Iis being provided the opportunity to show why the Ito possess, use, and transfer select agents and toxins should not be suspended or revoked. This action by the Centers for Disease Control and Prevention (CDC), Division of Select Agents an Toxins (DSAT) is based on the observations noted during the March 3-7, 2014 inspection of Speci?cally, the DSAT has signi?cant concerns re arding the administrative oversight of the select which are detailed below. Observation details citing speci?c regulatory provisions can be found in the Entity inspection Report dated May 12, 2014 for the March 3-7, 2014 inspection, to be submitted under separate cover. agent program does not have the appropriate administrative oversight by the Responsible Of?cial (R0) to ensure compliance with the select agent regulations, as required under section of the select agent regulations. Speci?cally, failed to implement the amended regulatory requirements published in the Federal? Register on October 5, 2012, their effective dates of December 4, 2012 and April 3, select agent program, conducted approximately 15 and 11 months after these effective dates, indicated a serious disregard for these regulatory requirements resulting in observed compliance departures in the security, biosafety, incident response, and training requirements of the select agent regulations. Interviews conducted by the DSAT inspection team indicated that the R0 was aware of the new requirements, but took no action to ensure a compliant select agent program. Speci?cally, onsite evaluation select agent program indicated that at least one of the 2 fully aware of the regulatory requirements as speci?ed in the notice of amended select agent U-S-C- 2 Accession Number: 232363 Page: 3 Scan Date: 2014-05-22 COPY I . page 2 of 4 regulations published on October and-had to attention-pt: theRO, but no further action was taken. - Speci?cally, the R0 failed to: 0 implement the security requirements described under section 11 of the select agent regulations, including but not limited to the security enhancements required for an entity in possession of Tier 1 select agents; implement procedures for pre-access and ongoing assessment of personnel suitability, including procedures for self? and peer? reporting and related training; - implement an occupational health program required for individuals with access to Tier 1 select agents; - fully develop an incident response plan that describes the response procedures required under section 14 of the select agent regulations; and 0 ensure all individuals are adequately trained according to section 15 ofthe select agent regulations. . alternate Responsible Of?cials (AROs) have been unable to effectively act for the USC- 2 R0 in his absence, as required under section 9(b) of the select agent regulations. The failure of to adequately empower the designated AROs has contributed to the state of U-S-C- 2 widespreac' regulatory non-compliance observed by the March 3-7, 2014 DSAT inspection team. has serious regulatory de?ciencies in sectional and 14 of the select agent regulations. U.S.C. 2 Specifically, - Procedures for the conducting pre-access suitability assessments of persons who have access to Tier 1 select agents, as required under section 1 l) ofthe select agent regulations have not has added personnel to their select agent registration U-S-C- 2 and granted access for these persons to the Tier 1 select agen] the April 3, 2013 effective date for this security requirement, in violation of section 1 of U.S.C. 2 the select agent regulations. These individuals currently have access to Tier 1 selectagents at the university. has failed to assess the suitability of personnel with access to Tier 1 select agents on U.S.C. 2 an ongoing basis, as required under section 1 In addition, establish procedures for self- and peer- reporting of incidents or conditions that affect an U.S.C. 2 individual?s suitability for Tier 1 access privileges, as required under section and train individuals with access to Tier 1 select agents on these reporting procedures and corrective actions concerning the assessment of their suitability, as required under section I of the select agent regulations and further described in Observations 8 and 10 of the Facility Inspection Report dated May 12, 2014. failed to implement the security requirement to protect Tier 1 select agent areas with an intrusion detection system when not physically occupied, in violation of of the This document is intended for the exclusive use of the recipientts) named above. it may contain sensitive information that is protected. privileged. or con?dential, and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient{s]. any dissemination. distribution, or copying is strictly prohibited. If you think you have received this docLITIent in error. please notify the sender immediately and destroy the original. . Accession Number: 232363 Page: 4 Scan Date: 2014-05-22 COPY I Page 3 0? has installed the hardware to adequately satisfy this U-S-C- 2 requirement, the entity has failed to render this system ope-rational.Additionally the'security' and i incident response procedures concerning an intrusion detection system have not been developed or implemented, as required under section I and 14(e)(1) ofthe select agent regulations and further described in Observations 12 and 21 of the Facility Inspection Report dated May 12, 2014. (bll3l3?2. has serious biosafety departures from the regulatory requirements under section 12 of the U-S-C- select agent regulations: Individuals with access to Tier 1 select agents at -m 2 health program U.S.C. 2 associated hazards, as required under section 12(d) of the select agent regulations. Additionally, inconsistencies and misunderstandings among entity personnel regarding 3)342 current respiratory protection program were noted by the DSAT inspectors. Inconsistencies in the implementation ofrespiratory protection can result in increased risk of exposme to infectious agents 262al?hl - by entity personnel that are not properly equipped or do not understand the use of the respiratory protection provided, in violation of section 1203) of the select agent regulations. Based on the seriousness of the reulatory departures outlined in this letter and detailed in the May 12, failed to meet the requirements of 42 C.F.R. Part 73. CDC has Lb??i4? can possess and use select agents and toxins in a manner which protects public health and safety. In lieu of taking steps to immediately suspend or revoke the certi?cate of registration, CDC is willing to to participate in a Performance Improvementle Program (PEPP) Under the conditions desires to participate in the PEPP, within fourteen (14) days of the date . should: use. 2 1. Provide DSAT with a. a written performance improvement plan describing discrepancies identified and speci?ed in the May 12, 2014 Entity Inspection Report Uisbi 2 i. The PEP must include a description of how th (b)i3)242 the requirements of 42 CFR Part 73', 2 ii. The PIP must include milestones and proposed timelines for resolution of regulatory departures. 2. Implement the plan immediately upon approval by 3. Provide to DSAT bi-weekly progress reports detailing milestones completed; 4. Agree to notify DSAT immediately of any situation that impacts the plan; and 5. Provide DSAT with Written con?rmations as departures are corrected. cease all work with Tier 1 select agents U.S.C. 2 and enter into a ?storage only? status with these agents until such time as the PIPP has been completed and its implementation deemed adequate by DSAT. This odoument is intended for the exclusive use of the recipientis} named above. it may contain sensitive information that is protected. privileged, or can?dential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientis}, any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender to: mediateiy and destroy the original. Accession Number: 232363 Page: 5 Scan Date: 2014-05-22 COPY Accession Number: 232363 Page: 6 I Page 4 of 4 decline to participate in the PIPP, all departures noted in May 12, 2014 Entity Inspection Report must be resolved, and a letter documenting the resolution thereof must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. DSAT inspects each registered facility to ensure that it meets the appropriate safety and security standards,-as well as training requirements, found in 42 CFR Part DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See 42 CFR 73.18). Resolution of all discrepancies will be confirmed by an onsite DSAT verification inspection. If you have any questions concerning this corresigndence, please contactl Robbin Weyant, T, USPHS Director Division of Select Agents and Toxins Of?ce Public Health Preparedness and Response Iu J. This document is intended for the exclusive use of the recipientts) named above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Scan Date: 2014?05-22 COPY DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control am and Prevention (CDC) Atlanta GA 30341-3724 September 5, 2014 (blt3lifi2 U.S.C. 2 Subject: Opportunity to Show Cause why the Select Agent Registration ofl -- suspended or revoked (blt3lfi2 U.S.C 2 Dear (bll3lifi2 I is being provided the opportunity to u_ 322 show cause why the registration oil I [b or revoked. Based on observations noted during the May 6~ U.S.C. inspection the Centers for Disease Control and Prevention Division of (blt3lif1: -- Select Agentsand'Toxins has signi?cant concerns regarding the compliance 0 (3)342 USC. 2 of the select agent and toxin regulations (See 42 CFR Part to). Section 73.3 of nose 2 .. provides that an entity's registration may be suspended or revoked for failure to meet the 2H U.S.C. 2 requirements of the select agent and toxin regulations. Speci?cally, the DSAT has signi?cant concerns regarding the compliance security, incident response, and record keeping requirements of 42 CFR Part T3, as well as the U.S.C. 2 administrative oversight of the select agents possessed and used summarized below (cited observations can be found in the Site Visit Inspection Report submitted under 2 separate cover): (1) Biosafety [42 CFR 73.12] and Registration [42 CFR has failed to implement a written biosafety plan commensurate with the risk associated ul?3334? 2 as required under sections 73.12(a) and ?3-12{b] of the select agent regulations including, but not limited to, the following items: described the propagation 2 identi?cation in a location that was not approved for select agent activities, did not have 2 sufficient biosafety and containment procedures (facility design and construction] to contain this select agent. and the laboratory practices used for manipulation of the agent were not commensurate with the risk of the agent, as required by sections 12(a) and 12th) of the select agent regulations. described the propagation of! I lattice U. 2 locatlon that was not approved for select agent activltles and not have suf?clent blosafety u_s_c_ 2 and centainment procedures (facility design and canstruction) to contain this select agent, as required by sections 7, 12(a) and 12th) of the select agent regulations. .. personnel handled vials of select agents held in long term storage without Ugo; appropriate personal protective equipment (PPE) during inventory audits and entity personnel stated that they did not routinely decontaminate PPE following work with select agents and prior to reuse. as required by section 12th} of the select agent regulations. .did not use a validated method for the inactivation of select agents suf?cient to 2 contain the agents prior to using the materials in unregistered locations, as required by Accession Number: 239869 Page: 4 Scan Date: 2014-09-09 COPY sections 12(a) and 12th} of the select agent regulations. Security [42 CFR 73.11] has failed to develop and implement provisions of its security plan to safeguard select U.S.C. 2 agents and toxins against unauthorized access, theft, loss, or release including, but not limited to, the following items: .. written security plan was not suf?cient to safeguard select agents from theft, U.S.C. 2 loss or release as the registered rooms were not secured at all times during select agent activities, select agents were incubated in an unregistered location, and provisions for inventory control were not implemented, as required under section 11(a) of the select agent ulations. .. - did not control access to select agents for activities conducted in the unregistered as required under section itla} of the select agent regulations. security plan failed to provide graded protection for select agents, as g2 uired under section 11(b) of the select agent regulations. . failed 'to adequately describe and implement procedures for inventory control for U.S.C 2 select agents that inspectors observed were held in long term storage, as required under section it out) of the select agent regulations. . failed to allow access only to individuals with access approval from the HHS 2 Secretary or Administrator, as required under section of the select agent regulations. Incident Response [42 CFR 73.14] has failed to develop and implement a written incident response plan that describes U.S.C. 2 response procedures that account for the hazards associated with the select agents listed on the registration, as required under sections ?3.14(bi, and ?S.14[d) of the select agent 2 regulations including, but not limited to, the following items: incident response plan did not clearly describe response procedures for the U.S.C. 2 theft, loss, or release of a select agent, as required under section 14(b) of the select agent . regulations. 3 342 - -- incident resonse Ian did not account for the hazards associated with the the appropriate actions to contain those agents, as required under section 14(c) of the select agent regulations. incident response plan did not designate personnet roles and lines of 2 authority and communication, as required under section 14(d)(5) of the select agent regulations. ..The- incident response plan did not contain information regarding planning and 2 coordination with local emergency responders, as required under section 14(di[5} of the select aent r'ulations. ..- incident response plan did not fully describe procedures for site security and U.S.C. 2 control as reuired under section 14(d)(10) of the select agent regulations. decontamination procedures did not adequately account for the hazards U.S.C. 2 associated with a potential release of select agents possessed . . - actions that would be needed to contain the select agents, as required under section of the select agent regulations. use. 2 Accession Number: 239869 Page: 5 Scan Date: 2014-09-09 COPY Accession Nombert Training [42 CFR has failed to provide training relating to select agent activities, including, but not limited to, the following items: failed to provide training to personnel that addressed the articular needs of the individual and the risks posed by the select agents possessed under section 15ta)(1) of the select agent regulations. 2 failed to provide incident responSe training to visitors before entering areas where select agents are handled or stored, as required under section of the select agent regulations. failed to ensure that the quiz used to verify that employees understood the training was accurate and effective, as required under section 15(d} of the select agent regulations. (5) Record-keeping [42 CFR 73.17] has failed to maintain records relating to select agent activities, including, but not limited to, the following items: failed to maintain an accurate, current inventory of its select agents held in long term storage. as required under section 17(a)(1) of the select agent regulations. failed to maintain for three years information about all entries into areas containing select agents, including the name of the individual, name of the escort (when applicable), and date and time of entry, as required under sections 17(a)(5} and of the select aent regulations. . has not implemented a system to ensure that select agent records and data bases are accurate and that their authenticity can be verified, as required under section of the select agent regulations. Responsible Official (so) [42 cm 73.9] Responsible Of?cial has not ensured compliance with the requirements of the select agent and toxin regulations. Based on the documentation available at the time of this inspection, the R0 has not ensured compliance with the requirements of 42 CFR Part 73 including, but not limited to, the following items: The RC) did not ensure that select agent activities were only conducted in approved physical certi?cate of registration, as required under section of the select agent regulations. - The RO did not ensure suf?cient biosafety and containment procedures were written and implemented to contain the select agents, as required under sections 12(a) and 12(b) of the select agent regulations. The RO did not ensure that a written security plan was developed and implemented to safeguard select agents against theft, loss or release, as required under sectioos 11(a), 11(b), 11tc), and 11(d) of the select agent regulations. The RO did not request or receive rior authorization by APHISICDC Form 2 for the transfer select agent regulations. The RO did not ensure that a written incident response plan was developed and implemented that describes response procedures accounting for the hazards associated with the select agents, as required under sections 14(b), 14(c}, and 14(d) of the select agent regulations. The RO did not ensure the inf rm ion and training on biosafety, security, and incident and visitors, as required under sections 15(a}, 15(c} and 15td) of the select agent regulations. 239869 Page: 6 Scan Date: 2014?09-09 COPY The RO did not ensure that records relating to the activities covered by this part were complete. accurate and maintained for three years. as required under sections ?le) and 17(c) of the select agent regulations. a The RO did not ensure that a system was implemented to ensure that all records are accurate and their authenticity can be veri?ed. as required under section of the select agent regulations. - The R0 was not familiar with all requirements of 42 CFR Part 73. as required under section of the select agent regulations. . Further. DSAT notes that some departures identi?ed during the May 2014l inspection were repeat ?ndings from site visits conducted in 2006. 2008 and 2011. These departures remain unresolved. In lieu of taking steps to immediately suspend or revoke possession, use. or transfer of select agents and toxins. the DSAT is willing to allo..to. 2 participate in the DSAT Performance Improvement Plan Program (PIPP) under the conditions use. 2 enumerated below. 1. Accession Number: a) Written con?rmation that the with select agents {with the exception of transporting select agent biohazardous waste in a U.8.0. 2 leak proof container for immediate autoclaving by SEA?approved individuals) and that ,_and will not be manipulated. in accordance with approve registration. 2 . will retain thel as physical locations for the use and storage of select agents that 8.0. 2 considers the departures noted in the report from the May 6-8. 2014 inspection for these registered areas. or if these laboratories will be removed for activities with identi?ed select c) A written performance improvement plan describing 40 discrepancies identi?ed and speci?ed in the site visit inspection report [submitted under U.8.0. 2 separate cover). including milestones for resolution of these discrepancies. decline to participate in the PIPP. all departures noted in the reportfrom the May 6-8. 2014 inspection must'be resolved no later than thirty {30) days of the date of this letter. Failure to fully respond to the departures may result in the initiation of proceedings for the registration to possess. use. or transfer select agents and toxins. As a condition of its PIPP agreement. by October 05. 2014.--n1ust..als.o.: 8.0. 2 a) Adequately address the following departures for the current inventory record. as noted in the report from the May 6-8. 2014 inspection: 8.0. 2 Requirement #1 [Section 1 Requirement #2 [Section 12{a). Section 12(b}] 2 Requirement #3 [Section 12{b)] - Requirement [Section b) Upon receipt of suf?cient documentation from for the requirements listed above noted in the report from the May 6-8. 2014 inspection. the DSAT will approve Ito its registration for the addition of the 2 239869 Page: 7 Scan Date: 2014-09-09 COPY must also: .S . 2 3. 4. Implement the performance improvement plan immediately upon approval by the DSAT. Provide to the DSAT bi-weekly progress reports detailing milestones completed until conclusion of the PIPP agreement. Agree to notify DSAT immediately of any situation that impacts the plan. Agree to resolve all 40 discrepancies identi?ed in the site visit inspection report in accordance with the approved plan. Provide to DSAT written con?rmations as discrepancies are corrected. Please be reminded that the DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations {See section 73.18). Resolution of all discrepancies will be con?rmed by an onsite veri?cation inspection by the DSAT. If ou have any questions concerning this correspondence. please contact use." 2 Accession Number: m/V Robbin Weyant, Captain, USPHS (Ret) Director, Division of Select Agents and Toxins Of?ce Public Health Preparedness and Response. CDC Department of Health and Human Services 239869 Page: 8 Scan Date: 2014-09-09 COPY he Q9 I, g" DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control ?in and Prevention (CDC) Atlanta GA 30341-3324 October 30, 2014 (blt3l?42 2 Subject: Opportunity to Show Cause why the Select Agent Registration of (enema I not be suspended or revoked USO 2 2 Dear 2 Iis being provided the opportunity to show cause why the registration Ishould not be suspended or revoked. This action by the 2 Centers tor Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) is based on the observations noted during the September 9 - 11, 2014 inspection DSAT has signi?cant concerns regarding the administrative oversight of the select agents and toxins U.S.C. 2 are detailed below. Observation details citing speci?c regulatory U.S.C. 2 provisions can be found in the Entity Inspection Report dated October 30, 2014 for the September 9 -l 2014 inspection, to be submitted under separate cover. In addition, the DSAT is concerned about the non- responsiveness of the Re5ponsible Of?cial (R0) andfor his alternate Responsible Officials (ARO) to regarding registration and inspection related concerns and requests. - cm agent program does not have the appropriate administrative oversight by the R0 to 30' 2 ensure compliance with the select agent regulations, as required under section of the select agent regulations. Speci?cally, - The September 9 - 1 1, 2014 osar inspection 3:42 implement the amended regulatory requirements published in the Federal Register on 2 October 5, 2012, by their effective dates of December 4, 2012 and April 3, 2013. Onsite (b)(3)142 select agent program, conducted approximately 21 and 1? months after USC. 2 these effective dates indicated this failure has resulted in non-compliance with required security biosafety, incident response, and training sections of 42 CFR Part 73 and 9 CF select agent program noted that, while physical U-S-C- 2 securit},r of the possessed select agents appears to be in place and appropriate, the near complete failure to establish written procedures and provisions to address the requirements for possession of Tier 1 select agents resulted in inspectors being unable to measure the implementation of the required security and safety measures. Noted deficiencies are outlined below and all de?ciencies are further described in the Facility Inspection Report dated October 30, 2014. Speci?cally, the RO failed to: Accession Nomber: 243985 Page: 6 Sean Date: 2014-11-05 COPY I Page 2 of 4 0 Implement the security requirements described under section 1 of the select agent regulations, including but not limited to the security and biosafety enhancements required for an entity in possession of Tier 1 select agents; 0 Establish procedures for pre-access and ongoing assessment of personnel suitability, including procedures for self- and peer- reporting and related training; 0 Implement an appropriate occupational health program required for individuals with access to Tier 1 select agents; 0 Fully develop an incident response plan that describes the response procedures required under section 14 ofthe select agent regulations; and 0 Ensure all individuals are adequately trained according to section 15 ofthe select agent regulations; 0 immediately notify CDC when two individuals? accessto select agents was terminated by the university as required under section 10 ofthe select agent regulations; serious regulatory de?ciencies in sections 1 (scourity), 12 (biosafety), and 14 (incident response) ofthe select agent regulations. Speci?cally, Procedures for conducting pre-access suitability assessments of persons who have access to Tier i select agents, as required under section 1 I) of the select agent regulations have not been established. Furthermore, since the April 3, ZOI 3 effective date ofthis security added personnel to their select agent registration and granted access for these persons to the Tier 1 select agents without conducting a pre-access suitability assessment ofthese persons in violation of section 1 of the select agent regulations. These individuals currently have access to Tier 1 select agents at the university. has failed to assess the suitability of personnel with access to Tier 1 select agents en an ongoing basis, as required under section 1 ofthe select agent regulations. In addition, has also failed to establish procedures for self~ and peer- reporting of incidents or conditions that affect an individual?s suitability for Tier 1 access privileges, as required under section 1 ofthe select agent regulations, and train individuals with access to Tier I select agents on these reporting procedures and corrective actions concerning the assessment oftheir suitability, as required under section 1 ofthe select agent has failed to establish written procedures for information security required under section 1 1 ofthe select agent regulations. r-has failed to establish an occupational health program specific to the Tier 1 select agents used and possessed by the university and enroll individuals with access to these Tier 1 select agents in said program as required under section 12 of the select agent reulations. failed to establish written incident response procedures and provisions required for possession of Tier I select agents, included by not limited to, appropriate reporting and site- Speci?c procedures to be carried out by entity personnel in response to an incident or emergency involving Tier 1 select agents, as required under section 14 of the select agent regulations. This document is intended for the exclusive use of the recipienttsi named above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientls]. any dissemination. distribution. or copying is strictly prohibited. If you thinit you have received this doCument in error. please notify the sender immediately and destroy the original. Accession Number: 243985 Page: 7 Scan Date: 2014-11-05 COPY Page 3 of 4 of the regulatory departures outlined in this letter and detailed in the October 30, 2014 has failed to meet the requirements of 42 CPR. Part 7'3. CDC has can possess and use select agents and toxins in a manner which 2 does not endanger public health and safety. In lieu of takin ste to immediately suspend or participate in a Performance Improvement Plan Program under the 2 to participate in the within fourteen (14) days of the must: I 1. Provide to DSAT a written performance improvement plan describing outstanding de?ciencies specified in the site visit inspection reports, including milestones for U-S-C- 2 resolution of these de?ciencies; Implement the plan immediately upon approval by Provide to DSAT bi?weekly progress reports detailing milestones completed; Agree to notify DSAT immediately of any situation that impacts the plan; Agree to resolve all deficiencies identi?ed in the site visit inspection report in accordance with the approved plan; and 6. Provide to DSAT written con?rmations as deficiencies are corrected. Milli-Alb.) cease all work with Tier I select agents and USC. 2 enter into a ?storage only? status with these agents until such time as the PIPP has been completed and its implementation deemed adequate by DSAT. decline to participate in the PIPP, all observations noted in the Site Visit Inspection reports U-S-C- 2 dated October 30, 2014 must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. Please note that items described in the report speci?cally pertaining to the requested addition of laboratories in the Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See section Resolution ofall discrepancies will be con?rmed by an onsite veri?cation inspection by DSAT. If you have any questions concerning this correspondence, please contact] M/e/ Robbin Weyant, REP Captain, USPHS (Ret) Director, Division of Select Agents and Toxins Of?ce Public Health Preparedness and ReSponse, CDC Department of Health and Human Services 57*: to This document is intended for the exclusive use of the named above. It may contain sensitive infonnaticn that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientts]. any dissemination. distribution. or copying is strictly prohibited. It you think you have received this document in error, please notify the sender immediately and destroy the original. Accession NUmber: 243985 Page: 8 Scan Date: 2014-11-05 COPY use. 262a[h) Facility {iti?ifgz Cc: Cc: Co: Co: Page 4 of 4 This document is intended for the exclusive use of the recipientts) named above. It may contain sensitive intonnation that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientts}. any dissemination. distn?bution. or copying is strictty prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Accession NUmber: 243985 Page: 9 Scan Date: 2014?11-05 COPY h?ti . DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Series is" - Centers for Disease Control ash and Prevention (CDC) Atlanta GA 30341-3724 November 19, 2014 (b)t3)?fi; U.S.C. 2 Subject: Opportunity to Show Cause why the Select Agent Registration of I should not be suspended or revoked 2 8.0. 2 - - (more; 8.0. 2 Section 73.8 of the select agent and toxin regulations (42 CFR 13.3) provides that an entity?s registration may be suspended or revoked for failure to meet the requirements of the select agent and toxin regulations. U-S-C- 1 Iis being provided the opportunity to show why the registration I to possess, use, and transfer select toxins should not be suspended or U.S.C. 2 2 revoked. This action by the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT is based on the observations noted during the November 18-20, 2013 and January 9, 2014 (bll3li42 was provided the observation details citing specific regulatory revisions in the 2 Entity Inspection Report (dated August 11, 2014) for these inspections. DSAT received espouse to the Entity lnsection Report on October 10, 2014 following a thirty (30) day extension requested Howeve response failed to fully address the reported violations of 42 CFR Part 73. 262ath) Furthermore, stated that it anticipates implementation of corrective actions to comply with 42 CPR 262mm Part of ['16 ?rst quarter (01) 2015, including installation of enhanced security provisions in Tier 1 select toxin and comply with the revised select agent and toxin regulations 3 _42 effective in April 2013. This timeline is not acceptable to DSAT. Additionally, DSAT has significant concerns _botuulinum neurotoxin possessed and used are summarized below. U.S.C-. 262301) - Failure twig?Ito ensure that its registered principal investigator (PI) controlling the select toxin 1vt ual responsible to the entity for the scientific or technical direction of the project or program. Failureb to ensure that all select toxin under the control of a principal investigator is stored ated only in registered areas in violation of 42 73.7. (bll3)342 Failure to restrict access to a select toxin to only individuals approved by the Federal rogram, Subsequent to a FBI security risk assessment, to have such access, in 262801) violation of 42 CFR 73.10. - I Further provided a ?restricted person? access to select toxin after the individual was denied access U.S.C. 262a[h) -Accession Number: 245249 Page:_3 Scan Date: 2014?11?24 COPY Acc?ssibn NUmber: 245249 Page: 4 Page 2 of 5 .. implement security enhancements for the possession and use of Tier 1 select toxin, effective April 3, 2013, in violation of 42 CFR 73.11. DSAT also has significant concerns regarding the security, biosafety, incident response, trainin, record possessed and used concerns are summarized below (see cited Observations found in the Entity Inspection Report submitted U.S.C. 2 under separate cover on August 11, 2014). Specifically: (1) 4g 2 is a registered entity that receivesl from its clients for the sole purpose of determiningl registered an individual as a not meet the definition of a principal 2 ?that was, at times, in excess of the regulated amount (designated by - 35 the ?Inventory internally transfers control of select toxin to anothed . [@1342 as the ?Toxin Testing indicate transfers to the unregistered non SRA-approved Toxin-Testing Pl occurred so that the company?s select toxin activities did not have to comply with the teen-irements of 42 CFR Part 73. The unregistered non BRA-approved Toxin Testing PI is responsible for scientific and technical direction of the entity?s select toxin program. These practices are in violation 2 (Bll3li4 (Ei?iil?? (b)(3)tfl2 of section 7 of the select agent and toxin regulations. U.S.C. 2 I lbll3)242 On October ifl?fl?l?d; requested to amend its registration to .. Iprincipal investigaton DSAT 2 acknowled es that this individual appears to meet the regulatory definition of a the unregistered non BRA-approved Toxin Testing PI, will continue to U.S.C. 2 U-S-C- 2 receive internal transfeteHeinlesathau.rom the registered PI, in violation of section 7. under the control of a PI registered to control an aggregate amount in U-S-C- 2 excesspf is regulated and must be used and stored at the registered entity in with 42 can Part 73. - 2 . use. 2 .. 5 '3 quantity amount of select toxin received from its clienteuas 2 records is not authenticated - an U.S.C. 2 ?a roximate? quantity amount 0 contained in each received in these samples prior to transferrin the 2 U.S.C--: non SRA~approved Toxin__Testin Pl. Based on own toxin concentration measurements 2625101) Perfomwd quantity amounts transferred into the 2 BRA?approved Toxin Testing PI to U-S-C- 2 from previous transfers remained under the control of the Testing PI prior to transferring his?c??t'f'dl" 2 has not complied with 42 CFR Part 73; its registered (and 2 USC: unregistered) investigators have controlled amounts of I - scientific and technical testing program is administered an unregistered 2 2 directing areas not registered'for the use or possession Restric-t-in'g'Access to Select Agents and Toxins {42 CFR 73.10) 2 (b -- ailed to restrict access to select toxin to personnel approved by the HHS Seeretary, in violation . . of section 10 of the select agent and toxin regulations. Specifically: . . .. including amounts that in aggregate exceeded U. . unregistered non-BRA approved P1 in violation of section 10(a), SC. 2 Scan Date: 2014-11-24 COPY '(b)(3)142 262801) use. 262a 262 am) Opportunity to Show Letter age 0 (b)t3):42 use. failed to the potential to gain access) to any quantity amount of (b)(3)142 I of a registered PI controlling an aggregate amount "to only SRA approved individuals, as required under sections 10(a) and 10(b), and 262301) provided a ?restricted person? access denied access approval. 262ath) 2623(h) Security {42 CFR 73.11} lb)l3)342 .. failed to develop and implement provisions of its security plan to safeguard select toxin against 2 unauthorized access, theft, loss or release including, but not limited to, the following items: 2 (b)(3)14 failed to implement Tier 1 security enhancements minimum of three security barriers, 2 ered area protected by an intrusion detection system unless physically occupied) and procedures for suitability assessments of personnel as required under section 11(1), failed to limit access to select toxins to individuals with access approval from the HHS U.S.C. 2 ecretary or the Administrator as required by section did not develop a written security plan sufficient to safeguard select toxin and did not U.S.C. 2 implement provisions for the control of access to select toxin under the control of a PI for and in unregistered areas, as required under section . U.S.C. 2 11(a), and (bll3l'ii2 failed to implement provisions for physical security, inventory control, and control of access 2 to select toxin as described in its security plan, as required under sections and - (4) Biosafety (42 CFR 73.12} - . not currently working with select toxins safely through its failure to implement a written 2 biosafety plan commensurate with the risk associated with the possession, use, and transfer of the select toxin, as required under sections 73.12(a) and 73.12(b) of the select agent and toxin regulations including, but not limited to, the following items: in areas that do not have sufficient biosafety and 2 containment procedures to contain the select toxin, commensurate with the risk of the toxin given - its intended use, as required by sections 12(a) and 1203). personnel handled select toxins without appropriate personal protective equipment (PPE) U.S.C. 2 and did not appropriately detoxify work surfaces, toxin containers, or potentially contaminated PPE, as required by section 12(b). failed to ensure that the biosafety and containment procedures were sufficient to contain the USO. 2 se ect toxins, as required under section 12(b). Incident Response (42 CFR 73.14) .. failed to develop and implement a written incident response plan that 'describesrresponse .0. 2 procedures that account for the hazards associated with the possession, use, and transfer of the select registration, as required under sections 73.14(d) and 73.14(e) of 2 the select aent and toxin regulations including, but not limited to, the following items: 4 plan did not clearly describe response procedures for the theft, loss, or release of a select toxin, as required under section 14(b), plan did not account for the hazards associated with the select toxin and appropriate contain the toxin, as required under secti0n 14(c), 3'42"? lan did not designate personnel roles and lines of authority during response 2-1, .422. E90 ?:70 0.2-2" 2-sci," 2 proce ures, as required under section - plan did not fully describe procedures for site security and control, as required under U.S.C. 2 section 14(d)(10), and Accession Humber: 245249 Page: 5 Sean Date: 2014-11-24 COPY Accession Number: 245249 Page: 6 (6) Training {42 CFR 73.15) Page 4 of 5 did not describe response procedures related to failure of the intrusion detection or alarm system and how the entity will notify the appropriate Federal, State, or local law enforcement agencies of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select toxins, ggfp?buhrgd under sections 14(e)(1) and Davarht I I has failed to relating to select toxin activities covered under 42 CFR Part 73 Inc uding, bullnotv-l-i'nii'iEd to, the following items: 0 I to ensure that the training provided to employees was understood, as required under sec ibn 15(d), and to provide training to visitors prior to entering areas where select toxin is handled or stored, as required under section [b)[3)242 U.S. . - Records {42 ems 73.17) has fail? maintain records covered unger CFR Part 73 including, but items: [rati??ii to ensure an accurate current inventory for select toxin held, as required under section lane), failed to ensure a record of information about all entries into areas containing select toxin including the name of the individual, name of the escort (when applicable), date and time of entry, as required under section and has not implemented procedures to ensure that records and databases created pursuant to the select agent and toxin regulations were accurate and their authenticity may be verified, as required under section (S) Responsible Of?cial {42 CFR 73.9) __Ihesponsible Of?cial (R0) has not ensured compliance with the requirements of the select agent and toxin regulations. Based on the documentation available at the time of the inspections, the R0 has not ensured compliance with the requirements of 42 CFR Part 73 including, but not limited to, the following items: The RO failed to limit the use and storage of select toxin to the registered area, as required under section 7, 0 The RO failed to restrict access to select toxin, as required under section 10, The RO did not ensure that a Written security plan was developed and implemented to safeguard Tier 1 select toxin against theft, loss or release, as required under sections 11(3), 11(c), 11(d) and - The RO did not ensure sufficient biosafety and containment procedures were written and implemented to contain the select toxin, as required under sections Ilifr Ir The RO did not ensure that a written incident response plan was developed and implemented that describes response procedures accounting for the hazards associated with the select toxin, as required under sections 14(b), 14(c), 14(d) and 14(e), 1- The RO did not ensure that training was provided, documented, and understood by individuals with access to Tier 1 select toxin, as required by section 15, I- The RO failed to ensure an accurate, current inventory for each select toxin held as required under section 1' The RC- did not ensure that records required to he kept by section 17 captured all of the required information, that these records were accurate and may be authenticated, and that written explanations Were provided for any discrepancies, as required by section 17, Scan Date: 2014-11-24 COPY (b use. 2 i The RO failed to ensure compliance with the select agent and toxin regulations during annual Page 5 of 5 inspections of the registered laboratory, as required under section and The R0 was not familiar with all requirements of 42 CFR Part 7'3 as required under section taking Staps imm?diately suspend Dr revoke the certificate of registration, DSAT is willing to U.S.C. allow th to participate in a Performance Improvement Plan Program (PIPP) dESimS ?0 days of the date of 1. Provide to DSAT a written performance improvement plan describing how I of the nine (9) regulatory departures identified and specified in the Entity Inspection Report (submitted under separate cover on August 11, 2014), including milestones for resolution of these Implement the plan immediately upon approval by Provide to DSAT written confirmations as discrepancies are corrected. Provide to DSAT bi-weekly progress reports detailing milestones completed; Agree to notify DSAT immediately of any situation that impacts the plan; Agree to resolve all discrepancies identified in the Entity Inspection Report in accordanCe with the usic. 2 decline to participate in the PIPP, all discrepancies noted in the Entity Inspection report must be resolved, and a letter doCUmenting the resolution thereof, must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent and toxin regulations (see section 73.18). Resolution of all discrepancies will be confirmed by an onsite verification inspection by DSAT. If you have any questions concerning this correspondence, please contact enumerate ow. 262a[h) departures; 2. 3. 4. 5. approved plan; and 5-- .S . 2623(h) (were I SC. 24 Accession Number: Robbin Weyant, RBP (ABSA) Captain, USPHS (Ret.) Director, Division of Select Agents Office Public Health Preparedness and Response, CDC Department of Health and Human Services 245249 Page: 7 Sean Date: 2014-11-24 COPY ?not, h? Lb, *0 Di Hull-cf a: ?can 3 2529:1- 3 2529:1- 2525:1- 'f DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 August 16, 2011 SUBJECT: Registration under 42 CFR Part 73 lsuccessful completion of its Performance Improvement Plan Program (PEPP). Based upon the observations noted during the inspection of your entity conducted on has addressed the oversight and ""mli'iti'safeiy"concerns noted during the inspections conducted on January 25-26, 201 and May 24,2011. Accession Number: You are reminded that in accordance with 42 CFR 73.18, the DSAT may at any time conduct an inspection of your entity to audit your compliance with the Select Agent Regulations: The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 CPR. part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certi?cate of registration should be amended to reflect changes in circumstances changes in the activities involving an}.r select agents or toxins). Prior to any change, the ReSponsible Official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CFR L33. 5 2523:31- Iwith the DSAT at Robbin Weyant, APT, USPHS Director Division of Select Agents and Toxins Of?ce of Public Health Preparedness and Response questions regarding this correspondence. This document is intended for the exclusive use of the recipientifs} named above. It may contain sensitive information that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. tfvou are not the intended recipient[s), any dissemination, distribution, or copying is strictly prohibited. vaou think you have received this document in error, please notifyr the sender immediater and destroy the original. 172070 Page: 3 Sean Date: 2011?08?22 COPY he #53542 #53542 #53542 LSC. #53542 Accession Number: 176052 strut-AL DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 . October 20, 2011 3 2529:?: SUBJECT: Registration under 42 CFR Part 73 2525:1- I has successfully completed the Performance Improvement Plan 5 for Disease Control and Prevention (CDC), Division of Select Agents This is to inform vnu that thg! rcgram (PIPP) with the Center and Toxins (DSAT). 3 2529:}1; 3 2529:}1; md during the most recent inspection of your entity on October 12, 2011, has addressed the oversight and biosafety concerns noted during the 2011 and August 16, 2011. Based upon the observa'ions not inspections conducted on May 3, Please ensure that the new departures listed in the inspection report, dated October 20, 201 1 are addressed within 14 days of receipt of this letter. Please also be reminded that in accordance with 42 .DSAT may at any time conduct an inspection of your entity to audit your compliance with the select agent regulations, either announced or unannounced. The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 C.F.R. part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certi?cate of registration should be amended to reflect changes in circumstances (Le. changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Of?cial must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CFR - #53542 L33. 2525:23- Please contactl Iwith DSAT, at questions regarding this correspondence. Sincerely, Robbin Weyant, RBP (ABSA) CAPT, USPHS (Ret) Director, Division of Select Agents and Toxins Office of Public Health Preparedness and Response This document is intended for the exclusive use of the recipicnds) named above. It may contain Sensitive information that is protected, privileged, or con?dmtiai, and it should not be disscminated, distributed, or copied to persons not authorized to receive soch information. If you are not the intended recipientts), any disaemination, distribution, or copying is strictly prohibited. if you think you have received this document in error. please notify the senderimmediately and destroy the original. Page: 3 -Scan Date: 2011?10?26 COPY s1? s} DEPARTMENT OF HEALTH AND HUMAN SERVICES stirft?g Ii, Public Health Service Centers for Disease Control" and Prevention (CDC) Atlanta, GA 30333 December 2, 2011 $513542 2525:1- ACCES lhas succeSSfully completed the Performance Improvement Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT). Based upon the observations noted dt ring the inspection of your enti :ees that the has addressed the and 21-22, 201 1. You are reminded that in accordance with 42 CFR 73.13, the DSAT may at any time conduct an inspection ofyour entity to audit your compliance with the Select Agent Regulations. LBS. 2525:??- concerns noted during the inspection conducted on June The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 C.F.R. part 33 to possess, use, or transfer select agents or toxins. Please be reminded that a certi?cate of registration should be amended to reflect changes in circumstances changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Of?cial must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CFR regarding this correspondence. 3 2529:1- Robbin Weyant, Director Division of Select Agents and Toxins Of?ce of Public Health Preparedness and Response with the DSAT at (ABBA) This document is intended for the exclusive use of the recipient[s) named above. It may contain sensitive information that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient{s), any dissemination, distribution, or copying is strictly prohibited. If you drink you have received this document in error, please notify the sender immediately and destroy die original. sion Number: 178319 Page: 3 Scan Date: 2013?12?07 COPY h! Eil??-I, LI nil! DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 October 30, 2012 LBS. 2525 3 2529:1- 262a[h) questions-"regardlug correspondence. SUBJECT: Registration under 42 CFR Part 73 lsuecessful completion of its Performance Improvement Plan Program Based upon the observations noted during the inspection of your entity conducted on October lD-l 1, 2012-, the CDCIDSAT agrees that addressed the oversight, security and biosaf?ety concerns noted during the inspections conducted on February 7-3, 2012 and April 10?12, 2012. You are reminded that in accordance with 42 CFR 73.18, the DSAT may at any time conduct an inspection ofyour entity to audit your compliance with the Select Agent Regulations. The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 C.F.R. part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certificate of registration should be amended to re?ect changes in circumstances (Le. changes in the activities involving any select agents or toxins}. Prior to any change, the Responsible Of?cial must apply for an amendment to a certi?cate of registration by submitting the relevant page(s) ofthe registration application (see 42 CFR LBS. 2525:??- Please contact with the DSAT at ?g??w??gl6%bbmJul?aed? bbin Weyant, CAPT, USPHS irectOr Division of Select Agents and Toxins Of?ce of Public Health Preparedness and Response $513,442 2525:: Aeceseion Number: This document is intended for the exclusive use ofthe reeipien?s) named above. it may contain sensitive infonnation that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient(s)_ any dissemination, distribution, or copying is Strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original. 197854 Page: 4 Sean Date: 2012?11?02 COPY "a .99 $91 ?hum DEPARTMENT OF HEALTH AN HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 March 7, 2014 #53542 3 2529:?: ?353,442 LBS. 2525:??- SUBJECT: Registration under 42 CF Part 73 Isuccessful completion of its Performance Plan Program (PIPP). Based upon receipt of your final reSponses on March 6, 2014 and $513542 2525:1- 2 a #53542 3 2529:?: resolution of all observations noted during the inspection of your entity conducted on December 1144, has addressed the oversight, security and biosafety concerns noted during the inspections conducted on February 24, 2012 and May 14, 2012. You are reminded that in accordance with 42 CPR 73.18, the DSAT may at any time conduct an inspeCtion of your entity to audit your compliance with the-Select Agent Regulations. The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 C.F.R. part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certificate of registration should be amended to re?ect changes in circumstances (ie. changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CFR 73.701?. livith the DSAT questions regarding this correspondence. Robbin Weyant, RBP (ABBA) Captain, USPHS (Ret.) Director, Division of Select Agents and Toxins Office Public Health Preparedness and Response, CDC Department of Health and Human Services Accession Number: 226952 Page: 6 This document is intended for the exclusive use of the recipient(s) named above. it may contain sensitive information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information, If you are not the intended recipientts), any dissemination, distribution, or copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the originaL' - Scan Date: 2014?03?11 COPY atHEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 July 1, 2014 ?3,413,442 2525:1- LBS. 2525:??- Accession Number: 235263 lsuccessful completion of its Performance Improvement Plan Program (PIPP). Based upon the observations noted during the inspection of your entity conducted on April 1- 3, 2014 and information rovided in res onse to the July 8-9, 2013 and December 20, 2013 inspections, the has addressed the oversight, security, biosafety, incident reSponse, and record-keeping concerns noted during the inSpections conducted on July 3-9, 2013 and December 20, 2013. You are reminded that in accordance with 4?2 CFR 73.18, the DSAT may, at any time, conduct an inspection of your entity to audit your compliance with the select agent regulations. The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 CFR part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certificate of registration should be amended to reflect changes in circumstances changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CFR I. ?zz ?ittobbm s. Weyant, Captain, USPHS (Ret) Director, Division of Select Agents and Toxins Office of Public Health Preparedness and Response Centers for Disease Control and Prevention Please contacl rrespondence. 5 Scan Date: Page: 2014-07-02 COPY 1 5 .. .- LBS. 2525:} - s! some: La or HEALTH AND HUMAN SERVICES to {h Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 July 3, 2014 ?3,413,442 2525:1- LBS. 2525:??- Accession Nomber: Dear- SUBJECT: Registration undEr 42 CFR Part 73 Isuccessful completion of its Performance Improvement Plan Program Based upon the observations noted during the inspection of your entity conducted on April 29 May 2, 2014 and information provided in response to the October 8-11, 2013 inspection, the CDC Division of Select Agents and Toxins (DSAT) agrees that the I oversight, security, biosafety, incident response, and record-keeping concerns noted during the inspectioiis conducted on October 8-11, 2013 and April 29 May 2, 2014. $53,442 L33. You are reminded that in accordance with 42 CPR 73.18, DSAT may at any time conduct an inspection of your entity to audit your compliance with the select agent regulations. The entity?s registration is valid only for the select agents and toxins listed, for the specified activities at the locations described in your application, and for the conditions that were approved under 42 CFR part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certificate of registration should be amended to reflect changes in circumstances changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CPR I, regarding this correspondence. obbin S. Weyant, Captain, USPHS (Ret) Director, Division of Select Agents and Toxins Office of Public Health Preparedness and Response Centers for Disease Control and Prevention 235467 Page: 3 Scan Date: 2014-07-08 COPY f?lbil?llbg 1M ?31? If}. LBS. Department of Health and Human Services Centers for Disease Control and Prevention Division of Select Agents and Toxins Atlanta, Georgia US. Department of Agriculture Animal and Plant Health Inspection Service Agriculture Select Agent Services Riverdale, Maryland USDA Pf? November 05. 2014 RE: Facility Inspection Report Response Entity Registration or Application Number: Thank you for your response concerning our report of the inspection of your entity conducted on August 29. 2013. The Federal Select Agent Program does not require any further response from you at this time. As the Responsible Official it is your responsibility to ensure that your entity meets the appropriate safety, security. emergency response plan. training, and record-keeping requirements found in 42 CFR Part 73. Please be reminded that the entity registration number is valid only for the specific select agents and toxins. and the speci?ed activities at the locations provided by the entity in the application package Form 1; see 42 CFR Part ?3.7 You must notify the Federal Select Agent Program in writing if a change occurs in any information submitted in the application package or amendments. To apply for an amendment to a certificate of registration. to add select agents or toxins. or to change specified activities or locations, an entity must obtain the relevant portion of the registration application package and submit the information requested in the package to the agency that issued the entity application or registration number. An entity or individual may not possess, use, transfer, or receive a select agent or toxin unless such activities are conducted for a lawful purpose and in accordance with the provisions of 42 CF Part 73. Anyone violating the provisions of 42 CFR Part T3 may be subject to civil andlor criminal penalties including imprisonment for not more than 5 years. Making of a false statement or representation to the Federal Select Agent Program is a violation of 18 1001, and may be punishable by a ?ne of not more than $250000. or a term of imprisonment for not more than 5 years, or both. If you have any questions concerning this correspondence, please contact your designated Federal Select Agent Program representative or visit our website at . It you are unsure who your designated representative is. please contact CDC Representative at: or APHIS Representative at 301-851?3300 option 3. 5 Marten Freeda E. 15336. DVM Robbin S. Wevant. RBP Captain, USPHS {Ret} National Director, Agriculture Select Director, Division of Select Agent Services Agents and Toxins United States Department of Department of Health and Human Agriculture Services Animal and Plant Health Centers for Disease Control and Inspection Service Prevention This document is intended for the exclusive use of the recipientisi named active. it may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminates. distributed. or copied to persons not authorized to receive Such information. If you are not the intended recipientlsi. any dissemination. distribution. or copying is strictly prohibited. It you think you have received this document in error. please notily the reassessmentseess Scan Date: Page: 2014-11-05 COPY Stu-1'1? u} til-44??. 4r r. OF HEALTH AND HUNIAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 November 26, 2014 L..S.C.. 2525:": SUBJECT: Registration under 42 CFR Part 73 Dear 1 2 L..S.C.. 2525:??- .. use. i successful completion of its Performance Improvement Hera-523w) Program Based upon the information provided in response to the November 5-7, 20l 3 and the Autist 4-6 2014 inspections, the one Division of Select Agents and Toxins (DSAT) agrees tha (b)(3)242 has addressed the concerns related to the safety of personnel and security of the select agents, noted during the inspections conducted on November 5-7, 2013 and August 4-6, 2014. 262a(h) You are reminded that in accordance with 42 CPR 23.18, DSAT may at an),r time conduct an inspection of Wm entity to audit your compliance with the select agent regulations. The entity?s registration is valid only for the select agents and toxins listed, for the speci?ed activities at the locations described in your application, and for the conditions that were approved under 42 CFR part 73 to possess, use, or transfer select agents or toxins. Please be reminded that a certi?cate of registration should be amended to re?ect changes in circumstances changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (see 42 CFR L..S.C.. 2525:??- regarding this conespondence. Accession Number: 245986 if you have additional questions Page: Robbin S. Weyant, REHABSA) Captain, USPHS (RetJ Director, Division of Select Agents and Toxins Office of Public Health Preparedness and Response Centers for Disease Control and Prevention 3 Scan Date: 2014-12-05 COPY ?3,413,442 2525:1'1, in.ch 5:19 (r netter +301 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 September 9, 201 1 ?3,413,442 2525:1'1; ?3,413,442 2529:1'1; successful completion of its Performance Improvement Plan ?3,413,442 2525:1'1; ?3,413,442 LBS. ?3,413,442 2525:1'1; 123523.442 ?3,413,442 2525:1'1; ?3,413,442 LBS. 2525:1'1 ?3,413,442 LBS. Program (PIPP). Based upon the observations noted during the inspection of your entity conducted on August 10?12, 2011, the Centers for Disease Control and Prevention, Division of Select Agents and Toni id the Animal and Plant Health Inspection Service, Select Agent Program (ASAP) agree ns a that. as addressed the oversight, inventory, record-keeping, and biosafety concerns identi note It. This or co [be?ttleotagentprogramai. he also has-the aut to act on behalf of the entity, as required under 42 CFR fied during the inspection conducted on January 10-14, 2011. Speci?cally, the inspection team the following during the August 10-12, 2011 inspection: ldemonstrated effective oversight, as required under 42 CFR He has the support and respect of all currently registered Principal Investigators (PIS) and Alternate Responsible Officials (AROS), and is actively engaged AS a member of the senior management team at ?3,413,442 2525:1'1; We wo Id like to err phasize the importance of continued oversight and active Director and Branch Chiefs es - ciall as the process to new ReSponsible Official who will likely not be part of the moves forward. I has bean activgly 1' nvolvcd in ens" I.ng that the b) (3): 42 milestones have been achieved, including activities such as updating plans and the Select UBLQ Agent User Manual, conducting unannounced and inventory audits, participatingling-?aw) training events, and handling select agent transfers. Further, the AROS stationed in have visited the . basis and have provided strong support to the .. select agent program, the (WW ?s registration (APHISICDC Form 1). The A305 are now able to the entity in the absence of the R0, as required under 42 CFR (3) The security plan had been updated to include all of the requirements of 42 CFR 73.11, and inspectors found no instances where the security plan had not been followed. Further, multiple training sessions had been conducted to ensure that all SRAnapproved individuals (139 people) had been trained on the new ?tailgating? policy. (4) The incident response plan had been updated to include all of the requirements of 42 CFR 73.14. (5) The inventory of each select agent held in long term storage for Principal Investigators (PIS) was found to be accurate and current, as required under 42 CFR with the exception of document is intended for the exclusive use of the recipient(s} named show. It may contain sensitive informatioit that is protested, privileged, n?dentiai, and it should not be dissorninated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient(s}, any dissemination, distribution. or copying is strictly prohibited. if you think you have received this document in error, please notify the sender immediately and destroy the original. Accession Number: 173261 Page: 3 Scan Date: 2011-09?13 COPY 3 2529:?: LBS. 2525:??- 3 2529:1- 3 2529:1- 3 2529:1- 252 am LBS. 2525:??- 2525:1- 3 2529:1- we Accession Number: PI departures identified in the January 10-14, 2011 inspection repo* een corrected for all PIs. 35:35-12 L33. 5 2523:31- a. The inspection team ted a 100% inventory for PI about 33 vs (1353 boxes) for PI inventory and approxima Ci:- content inventory (12 boxesrr'131) for PI -- I inventory, and approximately 3% of PI inventory. The inspection team verified that the inventories for PIs -- --.at1d imm- -- - it removed from the registration through amendment had been destroyed. Further the ?found material,? prevlous in freezer cage room 525M had been either destroyed or integrated into the long-term storage inventory. b. The inspection team verified that a bar-code system had been implemented to track the bar code label on each box, so that movement of select agent boxes from one freezer location to another, and back to its original location could be tracked. Further, the team I I verified that in the event of freezer failure, the L31 3252? in select agent registered space that could house select agents, avoiding the necessity of moving them to unregistered space. (6) The inspection team verified that all requirements of 42 CFR were available for th rough the use of multiple inventory logs. (7) The inspection team veri?ed that the entity had a mechanism to ensure that all records and databases were accurate and their authenticity could be verified, as required under 42 CFR (3) The inspection team found no instances of unauthorized access through review of access documents for all select agent door card readers for the following dates: 1l17i?2011, 1.8112011, 2i?4i'2011, 2l28i?2011, 3.1152011, 4l4r?2011, 4l22i2011, 5l24f2011, 6i?14/2011, 7f15l2011, and stencil. In addition, the entity had adhered to the written visitors accessin select agent areas, as required under 42 CFR Training on the escort policy had been provided during multiple training sessions to all SRA?approved individuals (139 individuals). (9) The inapection team visited registered space to verify the accuracy of the location of freezer units, as specified on select agent ?oor plans provided to DSAT and ASAP. discrepancies were found' 3-42 252m- (10) The inspection team verified that PPE usage for the freezer cage I, posted and consistently applied. The spill kit was located immediately outside of the freezer cage Please ensure that the new departures identi?ed in the attached inspection report dated 9r'1l2011 are addressed within 14 days of receipt of this letter. Please also he reminded that in accordance with 42 CFR 73.18, the DSAT may at any time conduct an inspection of your entity to audit your compliance with the select agent regulations, either announced or unannounced. The entity registration is valid only for the select agents and toxins listed, the specified activities at the locations described in your application, and for the conditions that were approved under 42 CPR. part 73, 7 C.F.R. part 331, or 9 C.F.R. part 121, to possess, use, 0r transfer select agents or toxins. Please be reminded that a certificate of registration should be amended to re?ect changes in circumstances (Le. changes in the activities involving any select agents or toxins). Prior to any change, the Responsible Official must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application (See 42 CFR This document is intended for the exclusive use of the recipient(s) named above. It may contain sensitive information that is protected, privileged, or confidential, and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is Strictly prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original. 173261 Page: 4 Scan Date: 2011?09-13 COPY 3 252m i L33. 2525:23- lell] [[13 AT at estions regarding this eorrespendenee. use. 2 additional we. wave Freeda lsaae. D.V.M. Robbin Weyant. PT, USPHS Director Director, Seleet Agent Program Division of Select Agents and Toxins National Center for Import and Of?ce ot?Publie Health Preparedness and Response Expert Veterinary Services. APHIS United States Department of Agriculture #53542 3 2529:1- Attaehment: inapection Report Gil/20] 1 This document is intended for the eseltlsit'e use nl'tlte idiot-e It mirt- sensilit'e is protected. privileged. or eon?dentitil. and it should not be disstl?ltittillud. distributed. or Copied to not to receive smelt lt'yeu are not the intended reei?enlts}. any dissemination. distribution. or engaging is slrietlj- prohibited. ll?jmu think you iltl't't.? received tloetnnent in error. please notify the sender ilttmedintel} deslruy the. utigillul. Accession Number: 173261 Page: 5 Scan Date: 2011?09?13 COPE #53542 3 2529:1- ::c5:3542 2525:1- LBS. 2525:??- LBS. 2525:??- ::c5:35-1-2 3 2529:1- OF HFI-HL fr-IU??Jf?i?iN SERVECES Purl?: Selina-rt "u - CPF er: #131? Ventral ll - ?my; (in. Niivcmlittr Hi. EU I Regimralinu under 43 CFR Part 73 Thank yin: fur _x agreezrient pamieipatc in 111:: Center-1 fur Tiliseum (Tammi :inc Prayer-mm Dfmiainn [DR-RT]Farfmriianuc imprm'emcnr Plan Program. Bram! upon the. ranted during in?pectiun :if you cmiiy canduulud um Oumhur 21 22, [he Curr-1cm 1hr Diwux?u :mr] Prcx'crtii?in. Din'isiun {11' Aguilar; {igrcc that 11:15 ux'crsigfir, im'unmiy, and hinsiifuly Cinnuurns during that inapudiirris camiqu UH EDIE: February 2i} EU and hit T-T'ri. ECHO. - I I I '3542 r: rm?nl. Th- DQIXT hur by [he smragu 0:113: rcqurrumums 1mm. Lil: .. n: gih?lralio i1. You an: reminded in accordance Wilh 4.7; (FR 73.1211. Lhn: DSAT may L11 an}; Eiitic conduct an rif ynur smiin [0 audit your Ci'JnfgiEian-m will] Lil-s 55:1ch Aguni chuluzinns. rcgisrruiirm i5 valid mil); for iilt? fit-16C! iigcms and Liixins Eisicai. ihu spacii?iud 3C iviIics aim liiL?IiEic'itih? descrihcd in your applicniiun. and far the lh?d'. wcru uppruvcd :im?lcr 42 CPR. 1mm 73? par: ?131. hr ?9 KILLER. part .121. an parasrsq, use. or IrrinsI'L-r Hem-:1 ugcms or onimsi Fiuiasu rcrriiniiud ?rm :1 {:ertil?imlc [if Tcgi?lr?ti?fl should hi: arriundml rc?ur: changer?; in (LC. changm in mi: invaiving any mica agents or {minim}. Prim 1g any Chung; 111:.- Official mum apply for em in ccriificaiu wt" rcgisiriiliim by Submitting 1h: relax-um pugcisy of 1h: applicant?: (55:5 4-1 CFR 3.1st In}. - - i" "35-1-2 2529:}1; [ht at Rohhin \k'syani. Phi), Direcan Divisin'in (if Seiucl Agcma and Tnxiris Oi'f'icu of Public Prcparcdnuss and This is iniendcd fir-r rh: exclusive rm: n1' :hi: recipictz??i named "Aime. I: may gunman .i?fisilii't? That in przwicged. or con?dcnliaL and j: 5.210th mm EH: (imaginnatcd? dwinijuzudl copicd 2-) Eul Lluihr ?zud iL?. rc-sci'v; Such inf-Lirmuiiufi. If ya :ccipignIJaj. an} diSStElilfl-J'IUR. distrihuzion. cz-r cvgy'trg ['ll'aihli?li??l'u'. ll 1h 25-; tun: rusted :lii3 In urrnr. phinu Mini) fin: .xcruli-i and damp (Eu: 33.442 use. i Departnent at Health a'ic: llcinan Services US. Department of Agriculture Centers for Disease Control and F?revention Animal and Plant Health lnspectior Service Division 0? Select Agents and Teams Se ect Agent Program Atlanta. GDD'gla Riverdale. Maryland uspg May 20. zero 2525:??- Facility Inspection Report Response 5:35-12 Robbin Weyant. SAITT. L-SPHS Director. Division o? Solos. Centers "or Disease Control and Department or Health ant: Htin'an thank you tor your response concerning our report or the inspection or your entity condticted on February at) the Select Agent Program does not recuire any turtl?ier response from you at this time. As the Responsib OltECiai it is your responsibility to ensure that your entity meets the appropriate safety. security. emergency response plan. t'aining. anc record?Keeping requnernents found in 42 CPR Part 1?3. Please be reminded that the entity registration numb-er is valid orin lor the specnic select agents and toxins. and he specilied activities at the locations provided by the entity in tre application package (APHISCDC Farm t. see 42 CFR Part 1'3? You notify the Select Agent Program in ii a charge occurs in any submitted in the appiication package or an To apply for an an or to a ceilitcate pl registration. to add selectageiils or toxins. or to change specific-Ll activities Ul lucdtioi a. an entity obtain the relevant portion of the i'egietr'attoi application package and submit the littorn'iatioi'i requested in the package to the agency that issued the entity application or registration An entity or ind vicual i?ray not possess use. transfer. er receive a select agent or toxin uh ess such activities are ccncucted a lawful purpose and in accordance With the provisions of 42 CFR Part 73 Anyone violating the provisions tide CFR Part 3?3 may be subject to civil andior crim'nal penalties including inprisnrinr-nt for not more tnan 5 years Making of a false statement or rep'esentat-nn to the Select Agent Program is a vioia'inri o? ?18 1-301. and may be punishable by a fine of not more than $256 000. or a term ct imprisonment for not more than 5 years. or both if you have any ocestions concern no this correspondence. please contact your designated Select Agent Progra-n representative or visit our website at ?gp; ll' yoc are unsure who your designatec representative is. please contact CDC Representative at' or Representat ve at 30? #356960. 1. or 47", Hot. ?anf?Jarfnn Freeda E. Isaac. Director. Select ?gent Pro-gram Veterinary Services. APHIS United States Department of AgriCiJIliire 724'. g. 2% Michael J. Firko. Director. Select Agent Program Plant Drotection and Quarantine. United States Department of Agriculture Agents and Preventie Services This Cocuimiit it trii the exclusive use of recipienth named above. It rray curtain sensitive that IS protected. pnwlegee. o' ctriticential. and :t not be dissen'ineted. distribute-ti. or cepied to persons not authorized to "ecclve Such if yam are rtot the ietr resipientle}. any dissemination. ct stribut on. or :or is strictly prchib:ted. [f you ll?ti'tk :i'oL. have tn-s ll": er Jase the star-tier immediately :nirt ctestroy ti'i rial. P2 in?: bli- limo E, DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service . Centers for Disease Control are", -- and Prevention (CDC) Atlanta GA 30341-3724 3 February 25, 201i ?3,413,442 2325:1'1; ?3,413,442 LBS. ..$ubject: Report of Site Visit ?3,413,442 LBS. Dear. and ?3,413,442 2325:1'1; On January 25 and 26, 2011, the following representatives from the Centers for Disease Co ed a site visit on to ensure complianc? with the select agent regulations (42 CFR Part 73): ?3,413,442 2325:1'1; 3):4 use 262a(h inimz present during the site visit included: ?3,413,442 2325:1'1; v0?) Based on observations noted during the Janua 25-26 2011 inspection, DSAT has the following to meet the requirements of 42 CFR 7'3. Details are noted in attachment 1: ?3,413,442 3 2529:1'1; - has not had the appropriate administrative oversight of select agent activities by the Responsible Speci?cally, wig L'S'C'Ez?zah? restricted access to select agents, as required under From December 1- 3, 2010, 4 individuals, who did not have approval to access select agents or toxins, were allowed to work with select agents in the registered 2525:" laboratory. In addition, a past shipment of select agents on August 26, 2008 had been received I) and in the custody of an individual who did not have approval to access select agents or toxins. Further, potentially contaminated waste is picked up 'by an outside contractor prior to decontamination. Accession Number: 161363 Page: 3 Scan Date: 2011?03?01 COPY $513,442 2525:1- LBS. 2525:??- 3 2529:1- submitted false statements to DSAT in aiiarent violation Page 2 of 3 Multiple citations from the 2005 and 2008 inSpections were again cited during the January 25 - 26, 2011' inepection, as follows: The R0 had failed to meet the requirement for ensuring that'corrective action had been taken for deficiencies identified during internal inspections conducted in 2009 and 2010, as required under 733(5). The R0 had failed to ensure that drills or exercises were consistently conducted for each of the last three years to test and evaluate the effectiveness of the security plan, as required under the biosafety plan, as required under and the incident response plan, as required under The R0 had failed to ensure that individuals listed on the entity?s approved certi?cate of registration had received training on biosafety and security in 2009 and 2010 prior to having access to select agents, or that visitors had received training for the last three years prior to entering areas where select agents were handled or stored, as required under 73.15 a . The had failed to provide refresher training to individuals listed on the entity?s approved certi?cate of registration, as required under The R0 had failed to ensure that provisions of the security plan were followed. Specifically, the plan states that cleaning personnel will be escorted when entering select agent registered Space, but these procedures were not followed on 12; 1632010 and 12f20l2010. ?0 The R0 had failed to develop a system to ensure that all select agent records were accurate, as required under Speci?cally, manual logs indicated the presence of an escort for visitors, but these records could not be reconciled by review of electronic access logs for the period of December 1-3, 2010. is not conducting work with select agents equivalent to the minimum national specified in the 5'h edition of the BMBL, which provides guidelines to ensure the safety of employees and the public. Specifically: U.S.C. 0 The R0 had failed'to develop and implement a written biosafety plan that is commensurat?jT?iih the risk of the select agent, as required under even though'has been registered since November 2003. The R0 had failed to ensure that the biosafety and containment procedures were sufficient to contain the select agent, as required under 73.1203). Specially, workers did not adhere to standard microbiological biosafety practices, including proper glove and hand washing procedures, proper procedures to contain aerosols when centrifuging select agents, and adequate waste handling procedures. Further, inspectors observed a serious penetration in laboratory, and certain aspects of the facility biocontainment controls had not been verified for U.S.C. 2 each of the last three years. 3 252901,- of 18 U.S.C. 1001. In response to the February 2008 DSAT inspection report, .provided in writing statements signed by the R0 that could not be verified on site during the January 2011 DSAT inspection. Speci?cally: The R0 stated in 2008 that cleaninv and maintenance is performed by individuals with area. This document is Intended for the exclusive use of the recipientts] named above. it may contain sensitive information that is protected, privileged, or confidential. and It should not be disseminated. distributed. or copied to persons not authorized to receive such information. It you are not the intended recipientls). any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender Immediately and destroy the original. Accession Number: 161363 Page: 4 Scan Date: 2011?03?01 COPY 3 2529:}LBS. 2525:??- . . speci?c security, biosafety, and incident response drills will occur two times per year, and that after each drill, the entity?s program will be reviewed and revised if necessary3,433,442 use. 3 2525:1? In lieu of takln immedlate steps to suspend or revoke the registration of . . I tees-:42 3 2529s.; 1. Provides to DSAT a written performance improvement plan descnbing how resolve the discrepancies identi?ed and speci?ed in Attachment 1, including milestones for resolution of the discrepancies; 2. Implements the plan immediately upon approval of the plan by 3. Agrees to notify DSAT immediately of any situation that impacts the plan; 4 Agrees to resolve all discrepancies identi?ed in the attached inspection report (Attachment 1) in accordance with the approved plan; and, 5. Provides to DSAT written confirmation as discrepancies are corrected. M3542 not request to participate in the PIPP, all discrepancies noted in Attachment 1 must be resolved and a letter documenting the resolution submitted to DSAT no later than thirty (30 calendar days of the receipt of this letter. - Please'be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations. Resolution of all discrepancies will be con?rmed by an onsite verification inspection by DSAT. Please note the continued failure to demonstrate thatl the necessary corrective actions to achieve compliance with 42 CFR Part 73 may result in the suspension or revocation of the entity?s certi?cate of registration. I LBS. 2525:??- If you have any questions concerning this correspondence, please contact I [dyed bin Weyant, CAPT, USPHS I. ector Division of Select Agents and Toxins Of?ce Puinc Health Preparedness and Response LBS. 2525: document is intended for the exclusive use of the recipientls} named above: It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. dislribuled. or copied to persons not authorized to receive such information. If you are not the intended recipientts). any dissemination. distribulion, or copying is strictty prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original. Accession Number: 161363 Page: 5 Scan Date: 2011?03?01 COPY smu- il ?110 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control Em and Prevention (CDC) - Atlanta GA 30341-3724 May 27, 2011 LBS. 2525:??- LBS. 2525:??- Report of Site Visit LBS. 2525:??- 52-523m- On May 3- 4, 2011, the following inspectors from the Centers for Disease ('30an and Prevention (CDCInning ?aimed a aim ?Ac-ii- n?F?fl?Ia .. I 3,433,442 3 2525:1? to compliance with the select agent regulations (42 CFR Part 73): U.S.C. 262a(h) 3?35? 2525:? Ind I present during the site #53542 3 2529:1- AcCession Number: 167057 Page: 4 Scan Date: 2011?06-01 COPY LBS. 2525:??- Page 2 of 4 3252 Based on observations noted duri the ay 3-4, 2011 inspection, DSAT has the following signi?cant i I to meet the requirements of 42 CFR Part 73. Details are noted in attachment 1: 3 2529:1- I select agent Program does not have the appropriate administrative Oversight of select agent activities by the Responsible Of?cial (R0). Speci?cally, II The RO failed to ensure that maintained complete records relating to select agent and toxin activities. Speci?cally failed to keep complete records of' information about all entries into areas containing select agents or toxins as required by section "i3 . l? of the select agent regulations. At the time of inspection, the electronic access control system (card ed to consistently record the entry and exit of individuals in the laboratories where select toxins are used and stored. This resulted in the failure to have complete records for all personnel entries into these select toxin laboratories. Furthermore, DSAT inspectors were unable to verify that only individuals granted access approval from the HHS Secretary or Administrator were provided with card keys that allow access to these laboratories, since an electronic roster of approved users could not be generated using the security ac ;rol system. Additional-1- I security access system was apparently undetected since Mi? not implemented procedures to ensure that records and data bases created pursuant to the select agent regulations were accurate, had controlled access, and their authenticity veri?ed, as required under section 73.17 of the select agent regulations. ill-3542 maintained complete records about all entries into areas containing select agents or toxins for a period of three years as required by section 73.17 of the select agent regulations. Speci?cally, at the time of inspection, electronic records for all .. where select toxins are used andyor stored, were maintained only for 45 days. In 2009 and 2010, the R0 failed to ensure that annual inspections were conducted for each laboratory where select agents or toxins are stored or used as required under section 739(5) of the select a cut regulations. failed to adequately provide biosafety training to personnel conducting toxin inocu ations in animals as required by section 73.15 ofthe select agent regulations. 0 Observations made during the 2006 and 2009 inspections were again identified during the May 3- 4, 201 inspection, and remained unresolved, as follows: The RO failed to ensure that annual reviews (and revisions, where necessary} of security, biosafety and incident response plans were performed during the last two years as required under section 73.1 1(i) (security), section 73.12(d) (biosecurity), and section 73. 14(d) (incident reSponse) of the select agent regulations. 3* The RO failed to ensure that annual drills or exercises were conducted during the last two years to test and evaluate the effectiveness of the security plan, as required under section 73.11(f) of the select agent regulations, and the biosafety plan, as required under section 73.12{d) of the select agent regulations. $513542 2525:1- 2525:1- LBS. 2525:??- LBS. 2525:??- LBS. 2525:??- . not currently working safely with select agent toxins. Speci?cally: associated with the possession, use and transfer of the select toxins on the registrations? I The RO failed to implement a written biosafety plan that is commensurate with the risk L.s.s. This document is intended for the exclusive use of the recipientts} named above. It may contain sensitive information that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. It you are not the intended recipientts}. any dissemination, distribution. or copying is stricny prohibited. If you think you have received this document in error, please notify the sender immediately and destroy the original. AeCeseion Number: 167057 Page: 5 Scan Date: 2011?06?01 COPY 3 2529:1- LBS. 2525:??- 3 2529:1- use. 3 2529:1- 3 2529:1- Page 3 of 4 requi section 73.12(a) of the select agent regulations. In developing its written biosafety has not incorporated the guidance found in the Biosafety in Microbiological and Biomedical Laboratories, 5th_Edition, the established national reference providing biosafety standards, procedures and practices, or requirements found in 29 CFR 1910.1450 (see Attachment 1, Observations 17, 20, 19. 30, 33, 35, 36, 37', 33, and 39). ?ed uncle The RO failed to ensure that the biosafety and containment procedures are sufficient to contain the select toxins, as required under section 73.12 of the select agent regulations (see Attachment 1 for specific observations cited). 3- Workers did not adhere to standard and special microbiological biosafety practices, as described in the biosafety plan, including proper glove and hand washing procedures (Observations proper procedures to contain aerosols during centrifugation, and sonication (Observations #13 and 29). operations that expose toxin solutions to vacuum or pressure (Observations #23 and 28); and proper decontamination of work surfaces (Observation and laboratory coats potentially contaminated with toxins (Observation 3* Interviews with several laboratorians revealed that engineering equipment biological safety cabinets) and personal protective equipment face, and respiratory protection), identified and referenced in the biosafety plan, were not used (Observations #20, 25, 26, and 27). In lie of taki steps to immediately suspend or revoke the certificate of registration, DSAT is willing to to partici ate in a Performance Improvement Plan Program (PIPP) under the conditions desires to participate in the PIPP, within fourteen (14} days of the date of should: 1. Provide to: DSAT a written performance improvement plan describing how 5252?; discrepancies identified and specified in Attachment 1, including milestones for resolution of these discrepancies; 2. Implement the plan immediately upon approval by 3. Agree to notify DSAT immediately of any situation that impacts the plan; 4. Agree to resolve all discrepancies identified in the attached inspection report (Attachment 1) in accordance with the approved plan: and 5. Provide to DSAT written confirmations as discrepancies are corrected. LBS. 2525:??- e?im willing or able to take the necessary corrective actions to achieve compliance with 4 Accession Number: 167057 ..Shou-ld--decline to participate in the PIPP, all discrepancies noted in Attachment 1 must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations. Resolution of all discrepancies will be confirmed by an onsire verification inspection by DSAT. 53,53,442 use. ?2525' Please note the continued failure to demonstrate that CFR Part 73 may result in the suspension or revocation of the entity ?5 certi?cate of registration. This document is intended tor the exclusive use of the recipientts} named above. It may contain sensitive information that is protected. privileged, or con?dential. and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. It you are not the intended any dissemination, distribution. or copying is strictly prohibited. If you think you have reseived this document in error, please notify the sender immediately and destroy the original. Page: 6 Scan Date: 2011?06?01 COPY 5:35-12 2525:1- Page 4 of 4 $53,442 L33. 32529:?? If you have any questions concerning this correspondence, please contact a: .. 5:35-12 2525:1- Ro bin Director Division of Select Agents and Toxins Of?ce Public Health Preparedness and Response eyant, CAPT, USPHS 12 This document is intended for the exclusive use of the reclpientts) named above. It may contain sensitive information that is protected. privileged, or con?dential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientis}. any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Accession Number: 167057 Page: 7 Sean Date: 2011-06?01 COPY DEPARMNT OF HEALTH AND HUMAN SERVIGES Public Health Service Centers for Disease Centrol view? and Prevention (CDC) Atlanta GA 303416724 4?6: ?i thl?r?l? Iuly13,2011 #53542 3 2529:1- LBS. 2525:??- . I - . io5j35-12 use. 3 2525:31? I On June 21-22, 2011, the following inspectors from the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the United States Department of Agriculture 32525311 Derfomed a 51' {8 vi git nf the #523542 I to ensure compliance with. the select agent regulations '(42 CFil Part 73): ?sh-?3542 LBS. 2525:??- 5 aim. #53542 LS . C1. 3221529?? 'n the 2 2011 inspection, DSAT has the following signi?cant . Based on observations noted dur. 252e:"1- . . . .- to meet the requirements of 42 CFR Part 73. Details are noted in attachment 1: #53542 3 2529:}1; I I ice-:42 select agent program does not have the appropriate administrative oversight of - select agent activities by the Responsible Of?cial (Bio)- SPBCi?ca?ye Signi?cant security?remrd- keeping, and biosafety issues were identi?ed as follows: Accession Number: 170186 Page: 3 .Scan Date: 2011?07-21 COPY #53542 3 2529:1- Page 2 of4 (1) Security. ,1 The RO failed to develop and implement site-specific policies in the written security plan that were sufficient to safeguard the select agents and toxins on the I-l??giS-tfati?? against unauthorized access, theft, loss or release, as required under sections 7? .11(a) and 252 - 73.11(b} of the select agent reulatio I . provided access only to individuals with access approval from the HHS Secretary or Administrator to laboratoriesl required by section 73.11 of the select agent regulations. aeci?callv, I granted unescorted access to: i) three individuals to laboratories and greater than 10 individuals to laboratory received access approval from the HHS Secretary or Administrator. Further, individuals without access approval from the HHS Secretary or Administrator performed autoclave decontamination of select agent waste and had access to packages containing select agents prior to shipment and receipt by the courier. - restricted access to select agents stored in laboratory {m .. as sections 73.10 and 73.11 Specifically, the -20C freezer located stored con?rmed select agent tissue samples and was not secured against unauthorized access per 73.11 A review of access records provided for June 2010, March 2011 identified that three unauthorized individuals accessed and had the ability to gain possession of a select agent in violation of section 73.10 of the select agent regulations. E53542 3 2529:1- L'I's'lzi 2529:1- 3_ 2525:}1; mgr-:42 2529:1- Cite. 3 25255-1- LBS. 2525:??- ::c5:35-12 252521, (2) Record-keeping mairtained complete records relating to select agent failed to keep complete records for each select agent and toxin held, including an accurate, current inventory that includes all information required by sections 1) and of the select agent regulations. Further, confirmed select agent tissue samples were stored for several years in laboratory is; 2525"" #53542 3 2529:1- ?3535 42 L. . 5:31,- not captured in the entity?s inventoesulted in the failure to have complete records ass; Additionally?failed to document information about all entries into areas containing select agents or toxins as required by section 73.17 of the select agent regulations. An entry log was not available for laboratories L'S'S'?z?zah? information about all visitor entries, including the name of the individual, name'of the escort. and date and time of ent . Further, this observation was previously noted during an April 2005 inspection-tori. In addition, inspectors were unable to verify that only individuals granted access approval from the HHS Sec or Administrator were provided with the loaner as the identity of the leaner card user could not be reconciled with the security acces'slcontrol system, and was not documented by the Security of?cer or with manual visitor entry logs. This resulted in the failure to have complete records for all entries into select agent laboratories. - I I L's; 32529371. had not implemented any procedures to ensure that records and data bases created pursuant to the select agent regulations were accurate, had controlled access, and their authenticity verified, as requ' -.. . .- 73.1? of the select agent regulation-s. maintained complete records about into areas containing select agents or toxins for a period of three years as required by section 73.17 of the select agent regulations. Specifically, at the time of inspection, electronic records for all LBS. 2525:1- ::c5:35-1-2 3 2529:1- LBS. 2525:??- This document is intended tor the exclusive use of the recipientis) named above. It may contain sensitive inionnation that is protected, privileged, or con?dential. and it shoUId not be disseminated, distributed, or copied to persons not authorized to receive such information. it you are not the intended recipient{s]. any dissemination, distribution, or copying is strictly prohibited, It you think you have received this document in error. please notify the sender immediater and destroy the original, Accession Number: 170186 Page: 4? Scan-Date: 2011?07?21 COPY 252e?n,? LBS. 252s?n,- LBS. 252s?n,- 252e?n,? 252e?n,? 252e?n,- users-252's" 2 In lieu of takin ates to immediately anew-m page - . 5. This document is intended tor the exclusive use of the named above. It may contain sensitive infon'netion that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. It you are not the intended recipientts), any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the original. Page 3 of 4 I, where select agents and toxins are used andfor stored, were maintained for one year. The R, 'led to ensure that annual inspections were conducted for each laboratory, specifically Room". where selecr agents or toxins are stored or used as required under section 773.9(5) of the select agent regulations for the last three years. Further, annual inspections conducted for the registered laboratories addressed only biosafety components and did not assess compliance with all parts of the requirements of 42 CPR Part 73. - The RO failed to ensure that annual reviews (and revisions, where necessary) of security, biosafety and incident response plans as required under section ?i3.11(f) (security), section 73.12(d) (hiosafety), and section 73.14(d} (incident response) of the select agent regulations were performed for each plan in 2009 andfor 2010. (3) Biosafe is not currently working safely with select agents and toxins. Specifically: - The RO failed to develop and implement site-spec ific policies in the written biosafety plan commensurate wiated with the possession, use and transfer of the select agents, registration, as required under section 73.12? agent regulations. In developing and implementing its written biosafety plan, not appropriately incorporatedthe guidance found in the Biosafety in Microbiological an Biomedical Laboratories, 5th Edition, the established national reference providing bio'Safety standards, procedures and practices, or requirements found in 42 CFR 73 and 29 CFR 1910.1450 - (see Attachment 1, Observations #13, 14, 15, 74, 3'5, 3?6, 77, 78, 79, and 30). LBS. 252s?n,- The RO failed to ensure that the biosafety and containment procedures are suf?cient to contain the select agents or toxins, as required under section 73.12 of the select agent regulations (see Attachment 1 for specific observations cited). - - is Biosafety cabinets and exhaust HEPA filters and housings were not certified annually as documented by certification records available at the time of inspection (Observations #64 and Workers did not adhere to standard and special microbiological biosafety practices, as described in the biosafety plan, including proper respirator doffing procedures proper procedures to contain aerosols during centrifugation (Observations #51 and 73); proper verification of directional airflow by laboratory personnel (Observations #63 and 70); and proper decontamination of biohazardous waSte (Observations #39, 40, 42, 43 s} Suspend or revoke the certi?cate of registration, DSAT is willing to . ce Improvement Plan Program (PIPP) under the desires to participate in the PIPP, within fourteen (14) LBS. 252s?n,- Provide to DSAT a written performance improvement plan describing how resolve the discrepancies identi?ed and specified in Attachment 1, including milestones for resolution of these discrepancies; Implement the plan immediately upon approval by Agree to notify DSAT immediately of any. situation that impacts the plan: Agree to resolve all discmpancies identified in the attached inspection report (Attachment 1) in accordance with the approved plan; and . Provide to DSAT written confirmations as discrepancies are corrected. _Acceseion Number: 170186' Page: 5 Scan Date: 2011?07-21 COPY $513,442 2525:1- L..S.C.. 2525:??- LBS. 2525:??- If ion have any questions concerning this correspondence, please contacll LBS. 2525:??- ?ned: g, Page 4of4 decline to participate in the all discrepancies noted in Attachment 1 must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirtyr (30) calendar days of the receipt of this letter. Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations. Resolution of all discrepancies willbe confirmed by an onsite verification inspection by DSAT. is willing or able to take the necessaryr corrective actions to achieve compliance with 42 CFR Part 73 may result in the suspension or revocation of the entity?s certi?cate of registration. Robbin Weyant, USPHS Director, Division of Select Agents and Toxins Office of Public Health 8.: Preparedness Response Centers for Disease Control and Prevention Freeda Isaac, DVM Director, Select Agent Program US. Department of Agriculture (USDA) I Animal and Plant Health Inspection Service Veterinary Services, National Center for Irnport and Export This document is Intended for the exclusive use of the recipient(s} named above. It may:r contain sensitive information that is protected. privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient(s}, any dissemination, distribution. or copying is strictlyI prohibited. it you think you have received this document in error, please notify the sender immediater and destroyI the original. Accession Number: 170186 Page: 6 Scan Date: 2011?07?21 COPY L33. 2525:23- L33. 5 2523:31- i on? DEPARTMENT or HEALTH AND HUMAN ssnvicss Public Heatth Service (awn I 1 Centers for Disease Control and Prevention .. Atlanta GA 30333 August 3, 2011 #53542 3 2529:1- 2525:1- LBS. 2525:??- Performance - E252 On July 29Show cause, why their select agent registration should not be suspended or revoked. As an alternative, the DSAT provided the I I the opponunity to participate in a Performance Improvement Plan Program (PEPP). DSAT has received your response dated August 4, 201 1, regarding your entity?s agreement to participate in the DSAT PIPP. with the understanding that the current registratior] win cominUe as and the-l I .. (biting? ill not perform any select agent work or activities. including transfers. until completion of the I- 252 PIPP. lhas agregd to respond to the full inspection report within seven (7) days of its receipt. and to provide DSAT with a written U-S-C- performance improvement plan desc (sieve use. will resolve the discrepancies identified during the inspection conducted on July 27 - 28, 262301] 2011. The full inspection report describing the departures from nationally recognized safety standards andfor deviations from requirements of 42 CFR Part 73 is included in Attachments 1-3. Inspectors from the CDC Select Agent Program who visited thel ?this? U-S-C- . I on July 27- 28. 2011 include the following: (blt3li42 .. This document is intended for the exclusive use of the recipient(s] named above. It may contain sensitive information that is protected. privileged. or con?dential, and it should not be disseminated. disttit-iuted+ or copied to persons not authorized to receive Such infonnation. It? you are not the intended recipientts). any dissemination, distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Accession Number: 171280 Page: 4 Sean Date: 2011?08-10 COPY (bjit3jiz42 U. S. C. 262a(li] the inspection included: I present during- (bjiisjizez Lise. 2625mm contact 2 this correspondence. Attachment 1: List of Facility Departures Attachment 2: Recommendations Attachment 3: ESL-3 Verification I if you have additional questions regarding bhin Weyant, CAPT, USPHS Division of Select Agents and Toxins Office of Public Health Preparedness and Re3ponse This document is intended for the exclusive use of the recipientts} named above. It may contain sensitive infon-nation that is protected privileged. or con?dential. and it should not be disseminated, distributed. or copied to persons not audiorizod to receive such information. If you are not the intended an}.r dissemination, distribution. or copying is Strictly prohibited. If you think you have received this document in error, please notify.r the sender immediater and desrroy the original. Accession Number: 171280 Page: 5 Stan Date: 2011-08?10 -COPY DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30341-3794 March 2, 2012 U. S. C. 262a[h] (bitsjzau use. unity to Show Cause why the Select Agent Registration ofI U. S. 262a[h] ii ib2 i3jlz42 U33 252 (bill Eg?ilpz .. 2523th (bili3?l:42 U.S.C. 2523th .. use. 2 ailu 33:42 use lshould not be suspended or revoked Deg (b)(3)242 U.S.C. 2628(h) Iltel . Iis being provided the opportunity to Show cause Why the registration Pfillel - -- I should not be suspended or revoked. Based on observations the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins has significant concerns regarding the .fit.i..l.u.te..o.f.thto be in compliance with the requirements of 42 CFR Part 73. Section 73.8 of the select agent regulations provides that an entity?s registration may.r be suspended or revoked for failure to meet the requirements of the select agent regulations. Speci?cally, the DSAT has si nifrcant concerns regarding the biosafety and securin ofthe select agents Of?cial (R0) has not demonstrated the appropriate administrative oversight ofthe entity?s select agent program. Further, serious record- keeping departures from 42 CFR Part 7'3 were identified during the inspection. These concerns are detailed below (cited Observations can be found in the Site Visit Inspection Report submitted under separate cover): in Biosafety is not currently working safely with select agents. Specifically: failed to implement a written biosafety plan that is commensurate with the risk 2 associated with the possession, use and transfer of the select agents on the--re-g-istrat.i.on.- required under section 73.l2(a} ofthe select agent regulations. in developing its written biosa?ety 2 (b)(3)242 .. has not incorporated the guidance found in the Biosafety in Microbiological and 2 Biomedical Laboratories, 5th Edition (BM BL, 5''1 Ed), the established national reference providing biosafety standards, procedures and practices (Observations #l6, 30-33, and 3667). Plan did not include risk and procedural information specific 2 for all the select agents used and stored in the instances of Outdated and inaCCurate information regarding laboratory-specific practices. 2 (b)(3)242 failed to ensure that the biosafetv and containment procedures were suf?cient to contain 2 the select agents, as required under section 73. i2 ofthe select agent regulations. Laboratory staffdid not adhere to standard and special microbiological biosafetv practices, including proper hand washing procedures (Observation #4 procedures for changing Accession Number: 183572 Page: 4 Scan Date: 2012?03?06 COPY $513,442 2525:":- I Page 2 of 5 gloves when contaminated (Observation procedures for the use of an electroporator to minimize aerosol exposures (Observation and consistent laboratory exiting procedures to minimize contamination with infectious material (Observations #33, 36, 44). Interviews with laboratory staff revealed that personal protective equipment (PPE), including closed-front laboratory gowns and N95 respirators, were routinely reused but not decontaminated prior to reuse. Further, reuse ofN95 respirators is not recommended, as efficient decontamination is not possible witltoutjeopardizing the integrity of the respirator (Observation Additionally, annual fit test records and Powered Air Purifying Respirators (PAPR) training records were not provided for all individuals using respiratory protection within the select agent laboratories (Observations #17, 32). Biosafety cabinets and exhaust High-Efficiency Particulate Air (HEPA) ?lters and housings were not certified annually as documented by certification records available at the time of inspection (Observations #3 7, 56, 57). Select agent facilities were rue-verified annually; however, several items were indicated as re-verification conducted during November 20] I and corrective actions were not documented (Observation ?353,442 3 2529:1- .. Sec does not currently have adequate provisions in place to ensure the security of the select agents. Speci?cally: 03 AT has been unable to determine whether the - M3542 L'S'S'Ez?zahi laboratory as requ1red by section 73.] i of the select agent 2 Security Plan must be implemented according to a site-speci?c ris assessment (73. 1] and ensure the security of the select agents contained in the RO verbally described an ?Institutional Security Plan? he was either unable or unwilling to provide a copy ofthis plan upon request prior to the DSAT inspection or upon multiple requests during the DSAT site visit. Section 73.] 1(b) oftlle Select age it reg lations requires that the security plan must be submitted upon request. failed to limit access to restricted areas to individuals with access approval from the HHS Secretary or the Administrator as required under section 73.1 of the select agent regulations. This failure, (Observation #1 l, 23), highlights the lack of procedures in place, or in practice, for the changingfremoval of access capabilities following staff changes as required under 73.] failed to ensure that individuals with access approval from the HHS Secretaly or the Administrator refrain from sharing with any other person their unique means of accessing the select agent as required under 73.] ofthe select agent regulations (Observation $53,442 L33. 2525:23- LBS. 2525:??- (3) Responsible Of?cial (R0) {42 CFR 73.9} Hafiz L'S'S'?z?zaii? select agent program does not have the appropriate administrative oversight of select Responsible Official (R0). Specifically, the no appeared unfamiliar with the requirements of 42 CFR Part T3 as demonstrated by a lack of familiarity with the select agent inventory tracking requirements, access and key control procedures, Form 4 reporting procedures, and repeated statements indicating disbelief of, or unfamiliarity with, the quantity and type of records requested pertaining to select agent activities during the DSAT inspection. The RO has held the current position since the initial registration of the entity on I ?19:03. However, based on the documentation available at the time of this inspection, the RO has failed to ensure compliance with the requirements of 42 CFR Part 7'3 including, but not limited to, the following items: 42 L. . 53353; This document is intended tor the exclusive use of the recipient-(s) named above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed, or copied to persons not authorized to receive such information. If you are not the intended recipientts). any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Accession Number: 183572 Page: 5 Scan Date: 2012?03-06 COPY ?353,442 LBS. 2525:}: ?Facility Site ?visit Report: Page 3 of5 i. The RC) failed to ensure an accurate, current inventory for each select agent heid in long-term storage as required under section 73.l 7 ii. The RO failed to ensure that annual inspections of select agent registered . use. 2 a .. laboratories were conducted for the last three years as required under section The RO failed to implement security access control provisions as stated in the security plan per sections 73.] 73.] 7?3.l ltd](3) and 73.1 iv. The RO failed to provide biosafety and security training to each individual with access approval from the HHS Secretary or Administrator before hei?she has access to select agents as required under section v. The RO repeatedly failed to produce a list of individuals granted access approval from the HHS Secretary or Administrator that was both current and accurate during the site visit as required under section 7?3. 1 vi. The RC) failed to ensure that annual reviews (and revisions, where necessary) ot? security, biosat'ety and incident response plans were performed during the last three years as required under section 23.] 1(1) (security), section 23.l2(d) (biosal?ety), and section 7'3. I 4(d} (incident response} ofthe select agent regulations, and vii. The RO failed to ensure that annuai drills or exercises were conducted during the last three years to test and evaluate the effectiveness orsecurity, biosafety and incident response plans as required under section 73.l 10?} (security), section 7?3. l2td) (biosafety), and section (incident response) ofthe select agent regulations. It is important to note that observations oracle during the 2009 and 2010 inspections ii, iv, and itemized above} were repeat de?ciencies noted during the February 6-7, 20 I2 inspection to implement the stated plan updates and procedural changes described in response to the DSAT site visits, conducted in February 2009 and Augus12010, into practice and into the select agent plan[s) submitted for review on January 24, 20 2 and February 2, 20l 2. DSAT believes this constitutes a serious breach of institutional integrity. The failure ofthc R0 to produce records for select agent activities for a previous three year period has been a recurrent issue. The observations from previous inspections that have yet to be addressed are noted in the present site visit inspection report {Observations 3, 9, l3, 23, 24, 25, 27, and 41). (4) Record-kee ing {42 can 73.17} 3 2529:1- activities per section 23. Upon request for documents by the DSAT inspectors, the R0 stated that the amount and type of records requested would require signi?cant time to gather and could not be completed during the site visit, and that these records would be produced in response to the formal DSAT inspection report. This is unacceptable. Section 73. I We) ol?the sele tagent regulations requires that all records created under this part must be maintained by the Hirer-- three years and produced upon request.? Further, on December 29, 20l l, 0 received prior written noti?cation of the records required for review during the site visit. Due to lack ofacknowledgement by the R0 of the initial notice an additional notification was resent on January 23, 20] 2. Additionally, DSAT inSpectors made multiple written and verbal reques, these records during the site visit. The failure to maintain and provide these records resuited in the inspectors being unable to verify that appropriate oversight. tra'ning, ?3,413,442 05.3. 52-52321,- preparedness, biosafety and security were in place for the select agent program at the time of the inspection (Observations 56, and This document is intended tor the exclusive use oi the recipientts] named above. It may contain sensitive information that is protected. privileged, or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information If you are not the intended recipientts), any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Accession Number: 183572 Page: 6 Sean Date: 2012-03?06 COPY $53542 LBS. 2525 - page 4 0135 $53542 LBS. 2525:??- WTh'e' failed to ensure an accurate current inventory for select agents -- held in long-term storage as required under section agent regulations. The inventory records maintained for the .. laboratory failed to capture any of the information required by section 73. 7(a)(l including the date, identity of individualts}, and purpose of use records for each time the select agent is ved from stora and returned to storage. Additionally, no inventory records :jo513542 2525:}1; . held In long-term storage In the -l-a-borator.y..up.o.n their transfer to the facility on May 5, 20] l, and usage of these a ents was also not documented. Additionally, discrepancies were noted in the current #241 .. has not implemented procedures to ensure that records and databases created pursuant to the select agent regulations were accurate, had controlled access, and their authenticity verified, as required under section 73.1? ofthe select agent regulations. Several departures were noted, speci?cally: H3542 aintain current select agent inventory records went had not implemented robust procedures to verify the accuracy Species. Additionally, DSAT inspectors noted diSCreancies in #53542 3 2529:1- LBS. 2529?..- ii'ii'iiz inventory (an unresolved ?nding from the 2010 site visit). However, teal-:42 rePQ?ed it had VPri?-grj inventor}.- thE weak Prior [0 the {most current: DSAT insp . but failec to identify these disorepancies. (Observations #27, 28) failed to implement a system for area access and key control databases used for granting access to registered laboratory space. Most notably, two individuals as well as one individual retaining electronic card access following their removal from the entity?s select agent registration (Observations #23, 40). #53542 3 2529:1- In lieu oftaking steps to immediately suspend or revoke the certificate of registration, DSAT is willing to to participate in a Performance Improvement Plan Program (PEPP) under the conditions myLaglugmghi desires to participate in the within fourteentl?l) days of the date of must: $53542 .. #53542 3 2529:1- l. Provide to DSAT a written performance improvement plan describing how the discrepancies identified and speci?ed in the site visit inspection report, including milestones for resolution ofthese discrepancies; 2. implement the plan immediately upon approval by Demonstrate signi?cant progress on the resolution of milestones by March 30, 2012, and complete majority ofmilestones prior to the current certificate of registration expiration date of May 1, 2012; 4. Provide to DSAT bi-weekly progress reports detailing milestones completed; Agree to notify DSAT immediately of any situation that impacts the plan; 6. Agree to resolve all discrepancies identi?ed in the site visit inspection report in accordance with the approved plan; and 7. Provide to DSAT written con?rmations as discrepancies said LJ decline to participate in the all discrepancies noted in the Site Visit Inspection report must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. This document is intended for the exclusive use of the recipientts} named above. It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. It voru are not the intended recipientts}. any dissemination. distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediater and destroy the original. Accession Number: 183572 Page: 7 Scan Date: 2012?03?06 COPY .. I Page 5 0f 5 Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations. {See section ?3.18) Resolution of all discrepancies will be con?rmed by an onsite veri?cation inspection by DSAT. If you have any questions concerning this correspondence, please contact I wash" ?353,442 LBS. 2525 Robbin Weyant, CAP USPHS (Rot) Director Division of Select Agents and Toxins Of?ce Public Health Preparedness and ReSponse #53542 3 2529:1- This document is intended for the exclusive use ofthe recipientis) named above. It may contain sensitive information that is protected. privileged, or con?dential. and it should not be disseminated. distributed. or copied topersons not authorized'to receive such information. If you are not the intended recipientis]. any,r dissemination. distribution. or copying is prohibited. If you think you have received this document in error. please notify the sender immediater and destroy:r the original. Accession Number: 183572 Page: 8 Scan Date: 2012?03-06 COPY I *?um?h ?a DEPARTMENT OF HEALTH AND HUNIAN SERVICES Public Health Service 15% Centers for Disease Control and Prevention (CDC) Atlanta GA 303416724 June 4, 2012 L33. 2525:1- Subject: Opportunity to Show Cause the Select Agent Registration of the I -- whim .. [Show be ?spade, mm M3542 L's; -- is being provided the opportunity to show cause the $513542 2525:1- use. 3 252591,- LBS. 2525:??- 2525:1- E33: 333 $53,442 25257.; 262ath .compl-ianee-of-the - I Should not be 3115an de or revoked. Based on observations noted during the May 1-4, 2012 inspection of the ?525:1 Prevention Div'sion of Select Agents and Toxins (DSAT) has signi?cant concerns regarding the with the requirements of 42 CFR Part 73. Section 73 .8 of the select agent regulations provides that an entity?s registration may be suspended or revoked for failure to meet the requirements of the select agent regulations. Speci?cally, DSAT has signi?cant concerns regarding the biosafety, securi administrative oversight, and record keeping practices observed during recent inspections of the I .. and Program. These concerns are detailed below (cited Observ ti us can found in the Site Visit Ins tion Re submitted under se rate cover $53,442 L33. 32529:?? 1iafety {42 CFR 73.12} is not currently workin with or storing select agents safely. In developing and implementing its - has not appropriater incorporated the biosafety standards, procedures, Laboratories (BMBL), 3th and practices found in the Biosafety in Microbiological and Biomedical edition- Speci?cally: ..iled to ensure that the biosafety and containment procedures were suf?cient to contain the so act agents, as required under section 73.12 of the select agent regulatiorlebsentation??l 5342 Em? i. The biosafety and containment procedures used for the propagation of .. I .. .. lwere select agent. Based on the ectors of the equipment and facili .. - allowed propagation in rooms with insufficient containment practices to contain the agent, a torn recommended biosafety standards in the BMBL 5?11 edition (BSL- observations of DSAT ins I. - I 'ocedural safeguards suff' cient to ensure secondary contairunent -- - viruses stored in a ommended biosafety standards - a rec in the BMBL 5?11 edition as], as is .. quarantine Pong? for (blismfor inventory purposes during the May 2012 site visit. This Accession Number: 189308 Page: 9 Scan Date: GEM (more 262ath> U-S-C- use 262a(h) (more - 2523i?) so. .30. . 26?aihl 262alh) Facility Site Visit RcPOriiI" I Page 2 of I r_ 262a(h) use-its {42 CFR 73.11} 'failcd to implement provisions of th security plan to safeguard'selectiagents against unauthori?Zed__ access, the?, loss or release in violation of section ll ofthe select agent regulations. Speci?cally: . I Eggaih) it During the CDC site visit, DSAT inspectors discovered that- possesses visits"! of regulate vials mislabeled stored in non-registered locations (bii3)'42 262301) in an unsecured manner (Observation to limit access to select agents to individuals with access approval from the HHS a Secrei'a?ryorthe Administrator as required under section 73 .1 i of the-select agent 262a(h) regulations. A roview. electronic access records and interviews oli ersonnel conducted by" 3342 030(3). 42 DSAT inspectors reveallacks an effective security access control system resulting U-S-C- 0' unauthorized access to select agents. As a result, non-SRA cleared individuals had access to? 262$?) 2 62a I I. This failure, (Observation highlights the lack of procedures inpiace, or in practice, for the control of access to select agents as required under 73.11 42 (more . use. (3)11 istratinn {42 can 73.7} and Restricting Access tn Select Agents {42 ore-73.10} gag-Eff 26mm") conducted work with select agents that had not been approved by DSA?I?eild failed to restrict i access to select agents to personnel approved by the HHS Secretary or theAdministratonfx? . discovered unauthorized work and storage ofl Iiil'"nonregistered SQ 262a(h) and equipment areas for 4 principal investigatorsl 262a{ I not 011 the entity?s certi?cate Of registration at the time W35 conducted (Observation -- laboratory personnel conducted work the Responsible Official and DSAT access ing their uly? 2009 to request approval by DSAT for the spore preparations directed by h) I (Observation It to provide control etc prevent unauthorized access as required by (b)i3)342 section ?Bil-deli the During the May 2012 CDC site visit, it was determined the failed to prevent approximater 15-20 individuals ?'on'l gaining access to 3 42 None of'tltegseindividuals had a security risk assessment conducted by the nor approval from or the Administrator (Observation . .S.C. 26261 26339? (4) Of?cial (R0) {42 CFR 73.9} (bli3)342 R0 has not ensured compliance with the requirements of the select agent regulations (observations #2 and Speci?cally: ai The RO failed to limit the use and storage of select agents to registered rooms per section 753 .7, ibii3i-42f The RO failed to request (andfor receive approval for) modi?ed select agent activities and personnel changes prior to allowing related activities to be conducted with select agents in a accordance with section 73.7, This document is intended for the excitene use of the recipienttai netted above. it may GDl'Ilain sensitive information that is protected. 2625101) privileged. or con?dential. and it should not be disseminated. distributed. or copied topereons not authorized _to leoeive such information. if you are not the intended recipientta). any dissemination. diatribullon. or copying is strictly prohdoited. If you think you have received this document in error. please notify the sender immediately and destroy the original. 1.393% Eager to Sean Dates cote-eerie We ?3 (3 i .. Page 3 of 3 i The R0 failed to ensure compliance with the select agent regulations during annual inapections of select agent registered laboratories based on documentation provided in April 2012 per section The R0 failed to restrict access to select agents per section 73.10, The R0 failed to implement security access controi provisions per sections ill and 73.1 The R0 failed to ensure sufficient biosafety and containment procedures to contain the select agenda) per section and a The R0 failed to ensure an accurate, current inventory for each select agent held in long-term storage as required under section 73.17 (5) Record-keeping [42 CFR 73.17} failed to ensure an accurate current inventory for select agents held in long?term storage as .S.C. 2 required under section 73.1? l) of the select agent regulations (Observation 42 has not implemented procedures to ensure that records and databases created pursuant to the .S.C. 2 select agent regulations were accurate, had controlled access, and their authenticity veri?ed, as required under section 73.17 of the select agent regulations. Speci?cally: (b)(3)342_ .. to maintain current and accurate select agent inventory records went had not irnplernented robust procedures to verify the accuracy SC. 2 iventory held in long-term storage failed to maintain accurate security access control databases, used for granting U.S.C. 2 SC. 2 personnel access to registered'laboratory space (Observations 5). In lieu of taking steps to immediately suspend or revoke the certi?cate of registration, DSAT is willing to to participate in a Performance Improvement Plan Program (PIPP) under the conditions desires to participate in the PIPP, within fourteen (14) days of the date of . . must: .S.C. 2 1. Provide to DSAT a written performance improvement plan describing how thwiltresolvetit? discrepancies identi?ed and speci?ed in the site visit inspection rcport, including milestones for U.S.C. 2 resolution of these discrepancies; Implement the plan immediately upon approval. by Provide to DSAT bi-weekly progress reports detailing milestones completed; Agree to notify DSAT immediately of any situation that impacts the plan; Agree to resolve all discrepancies identi?ed in the site visit inspection report in accordance with the approved plan; and Provide to DSAT written con?rmations as discrepancies are corrected. .. to participate in the PIPP, all discrepancies noted in the Site Visit Inspection USC. 2 report must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. This document is intended for the excitisive use ottne reeipientts) named above. it may contain sensitive intonnation that is protected: privileged. or con?dential. and it should not be disseminated. distribtned. or copied to persons not authorized to receive such information. If you are not the intended recipientts}. any dissemination. distribution. or copying is chie?y prohibited. it you think you have received this document in error. please notify the sender immediately and destroy the original. accession harshest teases ease?t it sees asset amazes?Jae; case (were I Pm Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See section Resolution of ail discrepancies will be confirmed by an onsite veri?cation inspection by DSAT. - If on have any questions concerning this correspondence, please contacl 1&2942 (more; . use. 2 U.S.C. 2 Robbin Weyant, RBP (ABBA) Captain, USPHS (Rec) - Director, Division of Select Agents and Toxins Of?ce Public Health Preparedness and Response, CDC Department of Health and Human Services This document is intended for the exclusive use of the recipientis} named above. It may contain sensitive information that is protected, privileged. or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such infon-nstion. If you are not the intended recipientts). any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. assessies we assess tease 11% sea essee assess?b0; cease $3 i 1% Jh??c a} Elm" [q e" ?e DEPARTMENT OF HEALTH AND HUMAN SERVICES if . Public Health Service Centers for Disease Control and Prevention (CDC) . Atlanta GA 30341-3724- May 16, 2013 .S . . Subject: Opportunity to Show Cause why the Select Agent Registration of I Ishould not be suspended or revoked USO 2 U.S.C. 2 .. U.S.C. 2 Section 73.8 of the select agent regulations (42 C.F.R. 73.8) provides that an entity?s registration may be suspended or revoked for failure to meet the requirements of the select agent regulations. I lis being provided the opportunity to Show reasonable 2 cause why the registration of I should not be suspended or revoked. This action by the Control and Prevention (CDC), Division of Select Agents and Toxins on: (may; Failure to adequately respond to the regulatory departures observed during the March 13-14, 2012 2 DSAT inspection as detailed in the facility inspection report issued April 19, 2012. As of the date of this letter, five departures noted during the March 2012 inspection remain unresolved. DSAT has not received an official response addressing any of these unresolved items since September, 2012. 0 Failure to adequately respond to the regulatory departures observed during the November 2128, 2012 DSAT inspection detailed in the facility inspection report issued January 14, 2013. Nine of the fourteen departures observed during the November 2012 inspection were repeated failures observed during the March, 2012 inspection. As of the date of this letter, no responses have been lb)l3)?fl2 to address any of the departures observed from the November, 2012 DSAT U-S-C- 2 inepection. 1 Failure to adequately respond to the requests for additional information regarding request for amendments to their certificate of registration. 'u .S. . 2 Additionally, in a letter dated June 5, 2012, the addressing all of the deficiencies noted by the DSAT during the March 13-14, 2012 inspection of your U.S.C. 2 facility (April 19, 2012 Inspection Report) as well as any outstanding compliance-related issues.? As has failed to provide an adequate response to address the regulatory 2 departures observed during the March 13?14, 2012 inspection (April 19, 2012 Inspection Report). Based on the information detailed in this letter, as well as many documented unsuccessful attempts to contact the Responsible Official (R0) to resolve these issues, DSAT has significant concerns regarding with the requirements of 42 CFR Part 73. 1 .. use. 2 2 Accession Number: 209832 Page: 3 Scan Date: 2013?05?20 COPY .30. does not exercise administrative oversight of select agent activities, and the R0 does not ensure compliance with all of the requirements of 42 CFR Part 73, as required under 42 CPR Further details of the of the-entity?s non-compliance are detailed above. zezarh .anm,% 3'42 In lieu of begin proceedings to suspend or revoke the certi?cate of registration, DSAT is willing td'a'llo'to participate in a Performance Improvement Plan Program 2 2'61 to participate in the PIPP, within fourteen U.S.C. 2 days of the date of this letter - must: 1. Provide'ttiDSAT a written performance improvement plan describing how'w'ill resolve the C. departures specified in the site visit inspection reports, as well as how will address (b)(3)242 submission of timely amendments to their registration, including milestones for U.S.C. I departures; . i Implement the plan immediately upon approval by Previde to DSAT bi-weekly progress reports detailing milestones completed; Agree to notify DSAT immediately of any situation that impacts the plan; Agree to resolve all departures identified in the site visit inspection reports in accordance with the - approved plan; and - U330 govide to DSAT written confirmations as departures are corrected. 2e2ath) weep decline to participate in the PIPP, all observations noted in the Site Visit Inspection reports dated April 19, 2012 and January 14, 2013 must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty calendar days of the receipt of this letter. DSAT inSpects each registered facility to ensure that it meets the appropriate safety and security standards, as well as record-keeping requirements, found in 42 CFR Part 73. DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See 42 CPR. 73.18). Resolution of all departures will be confirmed by an onsite verification inspection by DSAT. "dance, please contact I use. ?2 Robbin Weyant, RBP (ABSA) If ou have any questions concerning this corres Captain, USPHS {Ret.) U.S.C. Director, Division of Select Agents and Toxins 262a[h) Of?ce Public Health Preparedness and Response Centers for Disease Control and Prevention ea. Cc: This debument is intended for the exclusive use of the recipientls} named above. it may contain sensitive information that is protected, privileged, or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended reoipientis}, any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. Accession Number: 209832 Page: 4 'Scan Date: 2013?05?20 COPY DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30341-3?24 U.S.C. 262alh? August 14, 2013 262alh) 3 :42 U.S.C. . aim Opportunity to Show Cause why the Select?gent Registration ofl I be suspended or revoked (bll3)142 262af-h) U.S.C. 262a(h) -- earl: .. I. .- 262a?) ., (new I I is bei_ng..brovided the opportunity to show cause why the registration of: u_s_c_ "0t be suspende'd during the July 8-9, 2013 inspection for Disease Control and Prevention (C DC). Division of Select Agents and Toxins (DSAT) has signi?cant concerns regarding the compliance of with the requirements of 42 CFR Part 7'3. Section 73.8 of the select 262mm us regulations provides that an entity's registration may be suspended or revoked for failure to meet the requirements of the select agent and toxin regulations. Speci?cally, the DSAT has signi?cant concerns regarding the biosafety, security, incident response, record keeping, and administrative oversight of the select agents and toxins possessed and used by lThese concerns are summarized below i cited observations can be found in the Site Inspection Report submitted under separate cover): 262alh) (1) Security [42 CFR 73.11] failed to develop and implement provisions of its security plan to safeguard select U.S.C. and toxins against unauthorized access, theft, loss. or release in violation of section 11 of the select agent and toxin regulations including, but not limited to. the following items: It The entity has failed to implement Tier 1 security enhancements minimum of three security barriers) and procedures for suitability assessments of personnel, as required under section 11(f}. - The entity?s laboratory registered for the use and storage of Tier 1 select agents and toxin has a false ceiling that does not provide graded protection in accordance with the risk of the select agentor toxin, as required under section 11(b). 1- The entity failed to implement provisions for physical security. inventory control, and control of access to select agents and toxins as described in its security plan, including select toxins held that were not inventoried, an unsecured floor safe containing select toxins, and the intrusion detection system was not armed when the laboratory was unoccupied, as required under sections 11lcll2}. and use. 262arh) i2) Blosafety [42 CPR 73.12] I is not currently working with select agents and toxins safely through the failure to 2525101? implement a written biosafety plan that is commensurate with the risk use and transfer of the select agents and toxins on th 'i?egistration, as required under sections 73.12(a) and of the select agent and toxin regulations including, but not limited to. the following items: Accession NUmber: 214936 Page: 3 Scan Date: 2013?08-16 COPY on: 3 5:3? (?mm Accession NUmber: Entity personnel described the manipulation of up to 20 liters ofl of primary containment and without appropriate engineering controls or personal protective U.S.C. 2 equipment. Laboratory staff did not adhere to standard and special microbiological biosafety practices for -- including failure to use a biosafety cabinet "on other physical containment device for manipulation of infectious agents or toxins, inadequate personal protective equipment worn and reused without decontamination, nor did the bidsafety plan contain suf?cient information for animal procedures conducted with land production cultures or the inactivation procedures considered for .. I The entity's registeredLQaboratory had a false ceiling where ceiling tiles were previously caulked in a sealed surface, but the sealant appeared to have dried out and some gaps. Further, the ceiling was not constructed. sealed and ?nished in the same-general manner as the walls such that physical containment during a select agent or release may be com promised. Incident Response [42 CFR 73.141 I has failed to develop and implement a written incident response plan that describes response procedures that account for the hazards associated with the possession, use, and transfer of the select agents and toxins on th sections and T3.14(d) of the select agent and toxin regulations including, but not .S.C. 2 limited to, the following items: The entity's plan did not fully describe response procedures to theft, loss, or release of a select agent or toxin, as required under section 14(b). The entity's plan did not designate personnel roles and lines of authority during response procedures, as required under section The entity's plan did not contain information regarding planning and coerdination with local emergency responders, as required under section The entity's plan did not fully describe the procedures for site security and control, as required under section 14(d)(10). The entity's decontamination procedures did not adequately account for the hazards associated with a potential release of botulinum neurotoxins and such actions needed to contain the select toxin and protect emergency responders, as required under sections 14(c) and (4) Record-keeping [42 CFR has failed to maintain records relating to select agent and toxin activities covered under '42 CFR Part T3 including, but not limited to, the following items: failed to generate inventory records for select toxins held as required under section 17(a)(3) of the select agent regulations. failed to maintain records of all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and date and time of entry, as required under section has not implemented procedures to ensure that records and databases created pursuant to the select agent and toxin regulations were accurate, had controlled access. and that their authenticity could be veri?ed, as required under section b) of the select agent regulations. 214936 Page: 4 Scan Date: 2013?08?16 COPY use. 2 Accession Number (5) Responsible Official [42 CFR 73.9] R0 has not ensured compliance with the requirements of the select agent and toxin regulations. Based on the documentation available at the time of this inspection, the R0 has not ensured compliance with the requirements of 42 CFR Part ?3 including, but not limited to. the following items: The RO did not ensure compliance with the select agent and toxin regulations during annual inspections of its select agent registered laboratories, as required under section Ir The RO did not ensure that security provisions were implemented, as required under sections 11(3), 11(b}, and The RO did not ensure suf?cient biosafety and containment procedures were written and implemented to contain the select agent(s) and toxins, as required under sections 12(a} and 12(b). The RO did not ensure that a written incident response plan was developed and implemented that describes response procedures that account for the hazards associated with the select toxin, as required under sections 14(b) and 14(c). . The RO did not ensure that complete records relating to the activities covered by this part were maintained, as required under sections or The RO did not ensure that a system. was implemented to ensure that all records are accurate and their authenticity can be veri?ed as required under section 1T(b}. - The R0 was not familiar with the requirements of 42 CFR Part 73, as required under section Furthermore. the R0 appeared unfamiliar with several inspection ?ndings and stated to inspectors that these were "new" regulations despite previous inspection reports noting the departures. It is important to note that certain observations made during the 2003, 2005. 2008 and 2011 inspections were repeat de?ciencies noted during the July 8-9, 2013 inspection and remain unresolved. In lieu of takin ste to immediately suspend or revoke the certi?cate of registration, DSAT is willing to allow. to participate in a Performance Improvement Plan Program (PIPP) under the desires to participate in the PIPP, within fourteen {14} must: 1. Provide to DSAT a written performance improvement plan describing how will resolve the discrepancies identi?ed and speci?ed in the site visit inspection repo me U.S.C. milestones for resolution of these discrepancies; Implement the plan immediately upon approval by Provide to DSAT lei-weekly progress reports detailing milestones completed; Agree to notify DSAT immediately of any situation that impacts the plan; Agree to resolve all discrepancies identi?ed in the site visit inapection report in accordance with the approved plan; and Provide to DSAT written con?rmations as discrepancies are corrected. Shit-PP to participate in the PIPP. all discrepancies noted in the Site Visit Inspection report must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty (30} calendar days of the receipt of this letter. 214936 Page: 5 Scan Date: 2013?08?16 COPY Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See section Resolution of all discrepancies will be con?rmed by an onsite veri?cation inspection by DSAT. if you have any questions concerning this correspondence, please contact] - MW Robbin Weyant, RBP (ABSA) Captain, USPHS (Ret) Director. Division of Select Agents and Toxins . Of?ce Public Health Preparedness and Response. CDC Department of Health and Human Services 00 42. EM I Accession Number: 214936 Page: 6 Scan Date: 2013?08-16 COPY Accession Number: Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30341-3724 February 25, 2011 Report of Site Visit On January 25 and 26, 2011', the following representatives from the Centers for Disease Control and Prevention Division of Select Agents and Toxins (DSAT) performed a site visit -- l. to ensure compliance with the USO. 2 Based on observations noted during the Janua 25-26, 2011 inspection, DSAT has the following meet the requirements of 42 CFR 7'3. Details are noted in attachment 1: .. has not had the appropriate administrative oversight of select agent activities by the Responsible Speci?cally, lestricted access to select agents, as required under From December 1- 3, 2010, 4 individuals, who did not have approval to access select agents or toxins, were allowed to work with select agents in the laboratory. In addition, a past shipment of select agents on August 26, 2008 had been received 2 and in the custodyr of an individual who did not have approval to access select agents or toxins. Further, potentially contaminated waste is picked up by an outside contractor prior to decontamination. 161363 Page: 3 Scan Date: 2011?03?01 COPY use. 2 I I Page20f3 Multiple citations from the 2005 and 2008 inepections were again cited during the January 25 - 26, 2011' inapection, as follows: The R0 had failed to meet the requirement for ensuring that'corrective action had been taken for deficiencies identified during internal inspections conducted in 2009 and 2010, as required under 733(5). The R0 had failed to ensure that drills or exercises were consistently conducted for each of the last three years to test and evaluate the effectiveness of the security plan, as required under the biosafety plan, as required under and the incident response plan, as required under The R0 had failed to ensure that individuals listed on the entity?s approved certi?cate of registration had received training on biosafety and security in 2009 and 2010 prior to having access to select agents, or that visitors had received training for the last three years prior to entering areas where select agents were handled or stored, as required under 73.15 a . The had failed to provide refresher training to individuals listed on the entity?s approved certi?cate of registration, as required under The R0 had failed to ensure that provisions of the security plan were followed. Specifically, the plan states that cleaning personnel will be escorted when entering select agent registered Space, but these procedures were not followed on 12l16f2010 and 12f20l2010. ?0 The R0 had failed to develop a system to ensure that all select agent records were accurate, as required under Speci?cally, manual logs indicated the presence of an escort for visitors, but these records could not be reconciled by review of electronic access logs for the period of December 1-3, 2010. is not conducting work with select agents equivalent to the minimum national safety standards as specified in the 5'h edition of the BMBL, which provides guidelines to ensure the safety of employees and the public. Specifically: 0 The R0 had failed'to develop and implement a written biosafety plan that is commensurate with the risk of the select agent, as required under even thougli registered since November 2003. The R0 had failed to ensure that the biosafety and containment procedures were sufficient to contain the select agent, as required under 73.1203). Specially, workers did not adhere to standard microbiological biosafety practices, including proper glove and hand washing procedures, proper procedures to contain aerosols when centrifuging select agents, and adequate waste handling procedures. Further, inspectors observed a serious penetration in the laboratory, and certain aspects of the facility biocontainment controls had not been verified for each of the last three years. Isubmitted false statements to DSAT in apparent violation .. 31.342 e. ?2 use. 2 of 18 U.S.C. 1001. In response to the February 2008 DSAT inspection repo_rt, .provided in writing statements signed by the R0 that could not be verified on site during the January-m I 2011 DSAT inspection. Speci?cally: The R0 stated in 2008 that cleanin and maintenance is performed by individuals with This document is Intended tor the exclusive use of the recipientts] named above. it may contain sensitive information that is protected, privileged, or confidential. and It should not be disseminated. distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientts). any dissemination. distribution, or copying is strictly prohibited. If you think you have received this document in error. please notify the sender Immediately and destroy the original. Accession Number: 161363 Page: 4 Scan Date: 2011?03?01 COPY use. 262a :4 use 2 (b)(3)242 .. I Page speci?c security, biosafety, and incident response drills willEJ Per Year, and that after each drill, the entity?s program Will be and Q?z?th) revised if necessary. In lieu of taking immediate steps to suspend or revoke the registration 0 DSAT is lto participate in the DSAT Performance Improvement Plan Program 2626101) PIPP under the following conditions: Within fourteen {14) days of the date of this letter-_ (b)(3)142 Accession Number: If ou have an questions concerning this correspondence, please contact :42 Provides to DSAT a written performance improvement plan describing how will Please note the continued failure to demonstrate thatl resolve the discrepancies identi?ed and speci?ed in Attachment 1, including milestones for._resolution of the discrepancies; 3 . 42 2. Implements the plan immediately upon approval of the plan by 3. Agrees to notify DSAT immediately of any situation that impacts the plan; 4. Agrees to resolve all discrepancies identified in the attached inspection report (Attachment 1) in accordance with the approved plan; and, 5. Provides to DSAT written confirmation as discrepancies are corrected. Shouldl? lnot request to participate in the PIPP, all discrepancies noted in Attachment 1 ?must'be resolved and a letter documenting the resolution submitted to DSAT no later than thirty (30 calendar days of the receipt of this letter. Please'be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations. Resolution of all discrepancies will be con?rmed by an onsite verification inspection by DSAT. use. the necessary corrective actions to achieve compliance with 42 CFR Part 73 may result in the suspension or revocation of the entity?s certi?cate of registration. gees) [dyed bin Weyant, CAPT, USPHS . ector Division of Select Agents and Toxins Of?ce Public Health Preparedness and Response This document is intended for the exclusive use of the recipientis} named above: It may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated. dislrihuled. or copied to persons not authorized to receive such information. If you are not the intended recipientts). any dissemination. distrihulion, or copying is strictty prohibited. If you think you have received this document in error, please notify the sender immediater and destroy the original. Scan Date: 2011?03?01 COPY 161363 Page: 5 :9 1.;1 Illum? s" I ?hm use. 262a[h) should not be suspended'br revoked U.S.C. 2 I. Thel- - "l'is the opportunity to show cause why the registration of the to possess, use, and transfer select agents and (bii3)342 toxins should not bis-suspended or revoked. Based on observations noted during the October 8-11, 201-3 inspection of the the Centers for Disease Control and Prevention (CDC), Division 262arhy-am 9f Select Agents and Toxins has significant concerns regarding the compliance of with the requirements of 42 Part T3. Section T33 of the select agent regulations U_S"_fj_ 2 provides that an entity?s registration may be suspended or revoked for failure to meet the requirements of USO the select agent regulations. 2626101) regarding the administrative oversight of the select agents and toxins possessed and used by th'el lThese concerns are detailed below {cited Observation details can be found in the Site Visit Ins ection Fie ort transmitted via imile to the entit 262,31?) (b)(3)342 on November 6. 2013). 262a(h) and interviews conducted during the October 8-11, 2013 site visit, and ?mm-42 detailed inthl ISite Visit inspection Report dated November 6. 2013, the Flesponsible Official (R0) either does not have or does not exercise sufficient authority to ensureentity 2s2?fh) compliance with the select agent regulations, as required by 42 Part '33 and as evidenced by the Lisp: occurrences of non-compliance noted below. 2 62a (1) section 11 During time period of June, September, and the first week of October 2013. the a lowed an em ployee. recently fired for causefto have unescorted 42 . access to Tier 1 select agents and toxins in violation of its own security plan and consequently in 0f 42 and - On May 24, 2013. thel Iterminated the employment oi: -- select ?g?ht security mag 2 provides that unescorted access to seiect agents an' xins l5 res individuals with a current signed memorandum of understanding (MOU). Seel? A review of ac. 2 . was (b)i3)142 allowed unescorted access to registered space containing Tier 1 select agents and toxins, even (b)(3)342 he was notuaemployee and did not have a current signed MOU. Tier 1 select agents and toxin962am) U30 because they present the greatest risk of deliberate misuse with significant potential for 262mm mass casualties or devastating effect to the economy, critical infrastructure, or public confidence. and .. apparently unaware V13 Silwt't:_ DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service and Prevention Atlanta GA 30341-3?24 November 12, 2013 use. 262a[h) Centers for Disease Control _y the Select Agent pose a severe threat to public heaith and safety. Thel of this access until the inspection team from DSAT conducted a renewal the period October 8-11, 2013. Further, without the RO's knowledge and without the apparent authority 262301) Accession Number: 220340 Page: 3 Scan Date: 2013?11-15 COPY (b)(3)142 U-S-C- 3:42 use. 262ath) U- 2 deli-hi 62a 2 (b)i3)142 to class. authorized continuancg?f? access to select agents and toxins-?in an email sentt . 987mm 1. 2013-5 The resultis afaiiure of thel Ito implement provisions of the-its tesateguard select agents and toxins against unauthorized access. {m theft. loss or releases-HDSAT notes that a signed MOU for temporary employment existed between .I- $42 262a(h) and -. from Julv1,?2013tc August 31,2013. However. a current. signed dis-g for employmentwas netwevident for the erred of May 25, 2013 to June 30. 2013 or for any dates 2525101) after September 1.{gO13 substantiatingnuu?u employmentwith the] 2:221 (2i Restricting-access to select agentsland toxins: security risk assessments [section Theggarh) transferred to any-aroma 262mm amounts o1:Iat such time as was not hated on the] I 2 registration to possess. use, or transfer select agents and toxins in apparent violation of (W3). 42 ?1D(a) and 18 use. 2525101) to regulated amounts of the]: 262a while not Iiswd on the re istration to possess. use. or transfer select Secretariycrr-APHIS Administrator to have access to the regulated 262a(h) registered to possess. use 3 .42 or transfer settect agents ortoxins. regulated amounts U.S.C. ?175_b(b? 8.0. possessed regulated amoun i th while not registered my! - with eitherr'HHS or USDA to possess, use. or transfe. in apparent-violation of 18 [#30 262a :r-?Biological Safety Etcfes'sional, statin that his current inventory was 300 mg? i ?l as transferred from PI. 4:2 262ath :lr giving him a total of 1200 mg oil Ias of that date. There was no tight-Q (bits: 2 .36- had depleted the 300 mg oi: recorded 26'2a(h) 262.610] tabs in his possession on January'1 2012 prior to receiving the additional Quit) . 30' 262st hi This results in the total aggregate amount of toxin under thel'cantrol of (bli3f42 "having approval from the HHS Secretary or Administrator. to exceed theitodd mg permissible exclusion limit on January 30. 2012. 262mm 2 n2 8 at (3) Registration and related security risk assessment [section 701)]: . failed to ensure that the entity's registration had been amended to re?ect changes-in U-S-C- fricircumstances. as required by 42 can. 2:62am) I I employment had been terminated by thel . .. mks)?? on May 24. 2013. but he has never been removed from the entity's tegistration. remained registered for active work but inspectors were toIEtDaE?3e4ifne of at inspection that hissyork objective was ?storage only." i inventory [section IFIO failed to ens that complete and'accurate records relating to the activities covered by this part were maintained. as required underbxgi-y? U-S-C- 4? C-Fs teammate). Speci?cally: - 262aih) Lung homogenate samples. derived from animals-infected with a Ties-it select agent, from single 2?2a(h) source experiments. were not documented as required-under 0 An accurate. current inventory for select toxin held in amount of toxin removed from storage was not known or documented as required'e?nder ?17tait3i This is U.S..-C. 262a 262a(h) 262ath) This document is intended for the exclusive use of the recipient(s} named above. it may contain sensitive information that is protected. (b)(3)242 privileged. or confidential. and it should not be disseminated. distributed. or copied to persons authorized to receive such information. If you are not the intended recipient{s). any dissemination, distribution. or copying is strictl rohibited. If you think you have received this document in error. please notiiy the sender immediately and destroy the original. sf3yfii-2 use: Accession Number: 220340 Page: 4 Sc?g2a gate: 2013-11?15 COPY because as recorded in ?approximate? amounts per vial and toxin as vials rather than tracking total aggregate amount of toxin 262aih?)m final disposition as recluired under (5) Responsible Official [section 9 -i0 has not exercised sufficient administrative oversight of salad agent activities and has not ensured compliance with all of the 3 42 0 requirements of 42 CFR Part 73, as required under 42 Specifically: wagging As detailed above, the HO failed to: M33342 U53 0 Implement provisions of the entity's security plan. in particular those related to assessment. resulting in a terminated employee having continued access to select a agents and toxins; - 0 Ensure that only individuals with access approval from the HHS secretary or 0' (WSW USE administrator had access to select toxins; 2 ?252acmmu?m 0 Ensure that the entity's registration had been updated timely and appropriately; and Ensure that the entity's inventory records were current and accuratethe (more reports to thel -- quash) i I I. and the Pie and support staff report to 262aih) I We believe that this reporting contributed to the RO's insufficient administrative oversight .ct agent activities due to a failure to,? establish clear lines of authority between the HO, APO, and y, (b)(3)142 U-S-C- Further. we note that the immediate supervisor of the ARC) is the Director of the i' 2523?) who is also a registered PI with Tier 1 responsibilities. We are concerned as to how the ARC) 'could provide oversight of his supervisor when he is required to perform the duties of the R0 in the RO's absence' 4?2 2628?) recognizes that the current HO has only been in his position since July 30, 2013. 262a(h) (b)(3)342 in lieu of takingsteps to immediately suspend or revoke the certificate of registration. DSAT is w?iing to U.S.C. allow thel Ito participate in a Performance Improvement Plan Program (PIPP) tinder I Idesires to participate in the PIPP. within fourteen {1 days of the Imust: . (cystic use [b)t3) 42 262aih~3 will resolve the discrepancies identified here and specified in the site visit inspection report, including milestones for resolution of these discrepancies; implement the plan immediately upon approval by Provide to DSAT bi-weekly progress reports detailing milestones com pleted: Agree to notify DSAT immediately of any situation that impacts the plan; Agree to resolve all discrepancies identified in the site visit inspection report in accordance with the plan; and 6. Proii?idetg DSAT written confirmations as discrepancies are corrected. a written performance improvement plan describing how thel CT (.0 U1 4'5 (A) Should thel Idecline to participate in the PIPP, all discrepancies noted in the Site Visit Inspection report must be resolved, and a letter documenting the resolution thereof, must be submitted to DSAT no later than thirty (30) calendar days of the receipt of this letter. Please be reminded that DSAT retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations (See section 73.18). Resolution of all discrepancies will be confirmed by an onsite verification inspection by DSAT. This document is intended for the exclusive use of the recipientis] named above. It may contain sensitive information that is protected. privileged. or confidential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipientis}. any dissemination. distribution. or copying is strictly prohibited. If you think you have recaived this document in error. please notify the sender immediately and destroy the original. Accession NUmber: 220340 Page: 5 Scan Date: 2013?11?15 COPY If you have any questions concerning this correspondence. please contacj Fiobbin Weyant. ABBA) Captain. USPHS (Fist) Director. Division of Select Agents and Toxins Office Public Health Preparedness and Fiesponse. CDC Department of Health and Human Services Co: This document is intended tor the exclusive use of the recipientts} named above. it may contain sensitive information that is protected. privileged. or con?dential. and it should not be disseminated, distributed. or copied to persons not authorized to receive such information. If you are not the intended recipient{s]. any dissemination. distribution. or copying is strictly prohibited. if you think you have received this document in error, please notify the sender immediately and destroy the original. Accession NUmber: 220340 Page: 6 Scan Date: 2013?11?15 COPY Emma?s. Department of Health and Human Services U.S. Department of Agriculture g. Centers for Disease Control and Prevention Animal and Plant Health Inspection Service a! a Division of Select Agents and Toxins Agriculture Select Agent Services Atlanta, Georgia Riverdale. Maryland June 20. 2014 U.S.C.. 262alt) (more . . USO gSubject: Opportunity to Show Cause why the Select Agent Registration oi 26280? lshould not be ?or revoked 262alh) (blt3li4 Dea__ .S . C. 262alh) Section 8 of the select agent and toxin regulations provides that an entity?s registration may be suspended or revoked for failure to meet the requirements of the select agent and toxin regulations. is being provided the 3 in? lJ cause why Its registration for the possession. use. or transfer of select agents and 262501) toxins should not be suspended or revoked. (bxsy? lb)l3):42This action is based I to meet the requirements of the select agent and toxin 73 (HHS) and 9 CFR Part 121 (USDAH. Speci?calle 2625101) 2525101) failed to: 0 Implement procedures for conducting a pre-access suitability assessment of persons who will have access to a Tier 1 select agent or toxin in apparent violation of section 1 l) of the select agent and toxin regulations. Implement an ongoing assessment of the suitability of personnel with access to a Tier 1 select agent or toxin in apparent violation of section 1103(3) of the select agent and toxin regulations. In lieu of taking steps to immediately suspend or revoke thel registration for the possession, use, or transfer of select agents and toxins1r the Federal Select Agent 2 Ito participate in a Performance Improvement Plan (PIP under the conditions enumerated below. 1. Within fourteen (14) days of the date of this IetterJ Federal Select Agent Program oftheir intention to participate in the PIPP. 2 lbll3li42 I must submit a weekly update beginning July ?It, 2014, and each Friday thereafter until conclusion of the PIPP agreement, describing the progress made towards resolution of departures from section 11mm and section 11(f)(3) of the select agent and toxin regulations. 3. Within sixty (60) days of the date of entering into the PIPP agreement with the Federal Select -- Imust have adequater addressed all departures from 2 section 11mm and section 11(f}(3] of the select agent and toxin regulations. Accession Number: 235074 Page: 3 Scan Date: 2014-07-01 COPY departures may result in the initiation of proceedings for the suspension or revocation of - -- registration to possess, use, or transfer select agents and toxins. U.S.C. 2 Please be reminded that the Federal Select Agent Program retains the authority to conduct announced or unannounced inspections at any time to ensure compliance with the select agent regulations. If ou have anlrr questions concerning this correspondence. please contactl 5. ?if hD, Captain, USPHS (Ret) Director, Division of Select Agents and Toxins Of?ce of Public Health Preparedness and Response Centers for Disease Control and Prevention Accession Number: 235074 Page: 4 Scan Date: 2014?07-01 COPY DEPARTMENT or a HUMAN P-Jblir: Health Service a- Centers for Disease Control and Prevention Atlanta GA 35333 March l9, 2010 U-S-CI- 2.62am) 2 62 a h) - (b)(3)242 (b)(3)242 I U.S.C. 2626101) to Show Cause why the Select Agent . I should not be suspended Ur/r?evolse? [bxsy?rz (b)(3)i42 it has been determined that the has failed to comply wim the U-S-C: 2625101) biosafetjr concerns noted during the inspections conducted on August 13, December 2009, and February 16, 2010 {see attached Facility Inspection Report). Although the Centers for Disease Control and? (bli3)342 Prevention (CDC), Division of Select Agents and Toxins acknowledge the efforts that the]: I has undertaken since these inspections, it is the intention of DSAT to begin the 2625101) administrative process to suspend or revoke the registration of the fb?ifg?t?j (b)(3)242 unless the I can show cause wit}r their Select Agent suspended or revoked. USO 262nm) 2628mm . . . . . . i As an alternative to proee drugs, DSAT is Willing to allow I to participate in a DSAT Performance improvement Plan Program 26 Whit-1h Will allow the I to continue its current registration as conditions: the I. 1. will provide to DSAT written assurance that no select agentiivork or activities. including transfers. vrill 2525101) be performed or conducted until completion ofthe-Pllji?; 2. will provide to DSAT a written performsneer-improvement plan describing how .. lwillxre-solve the discrepancies identified during the inspections 2625101) conducted on August lit. le?gj?Dec'Ember ET, 2009, and Februaryr 16., Bill If] within 6t) days of reec?sa?m) this letter: 3. understands that DS?T?ivill use the entity?s written plan to monitor and provide technical assistance to assist Ito come into compliance with the Select Agent 262a[h) 4. ?fills-esolve, not later than July 10, 2010. all discrepancies identi?ed in the attached inspection report and, [b)[3)242 will provided to DSAT a written confirmation once all of the discrepancies identified during the inspections conducted on August 18, 2009, December 17, 2009, and February 16, 2010 have been 2628(h) corrected. (b)(3)242 Should the lagree to participate in the PIPP. you are retains the authority to conduct unannounced inspections to ensure compliance with the 262a(h) Select Agent regulations, and that a DSAT in5pector team Twill be scheduled to conduct a verification site visit prior to your successful completion of the and a return to full registration. This decument is inlended for the exclusrve use oftne named abuse. I: may contain sensitive infornatlicn that is protected isn't-liege; or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended rccipientfs], any dissemination. distribution. or copying is skied},r prohibited. [Fyou think you have received the document in error, please notify the sender immediatelv and destroy the orir'""' 46? ospaannmr or HEALTH a HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention Atlanta GA 30333 March 9, 2010 use. 262nm), b)(3)242 U.S.C. 2 (b)(3)242 SUBJECT: Opportunity to Show Cause why the Select Agent Registration of (b)[3)243 U.S.C. Isliould not be suspended or revoth 262ath) 262a(h) On February 24. 2010, the Division of Select Agents and Centers for Disease Control and Prevention (CDC) issuedl Ian ?Order to Cease and Desist Violations of the Public and Response Act (42 USJC. 262a)" batted signi?cant concerns regarding-{he failure oi] 262a(h) compliance with the requirements T3 oI'T-itle 42 of the Code ot tederal Regulations {42 Part l. Thel does not have an inventory system that maintains current and accurate in Fonnation regarding regtilated'itoxins possessed by I ?gsg'42 as required by 42 CFR 73.17. i0)i3)342 262- ~31 I has allowed unauthorised access to regulated toxins in al violation of 42 ch? 73.10. (b)[3)242 3- Thel [does not have the appropriate of by the Responsible Of?cial as required by 42 CFR UISIC- gegafh) 4. lrengtikee-pin'gi'aiid security measures are not adequate tonneg?z?'m) ensure that the select agents and 'tgttittsaafersafeguarded from the? or loss as required by 42 l. 5. Tltel does not have a biosaiety plan the risk of the select agents and toxins possessed by the las required by 42 3 _42 CFR 73.12. (U 6- Th? Idoes doth-avehiosafety and containment procedures use. . . .. 262mm 262mm commensurate With the risk of the selectagents and towns-possessed hy thel -- as required by 42 12. The has failedito provide select agent training to those individuals allowed to access the select agents and toxins possessed by thel 262mm required by 42 CFR 73.15. are. (b)t3)'42 - . . 262a[h) Although the Animal and Plant Health Inspection?Sewice and DSAT acknowledge the efforts that the I lhas undertaken since the Februa 18-19 7010 ins t' 't "ti 2628101pee lon,t is to intention ofthe Select Agent Program to begin the admlnistrattve process to suspend or revoke the Select Agent hrogram registration .. lunlesg (b)(3)242 why their Select Agent registration should not be suspended or revoked. 262a[h) a, 262athl (more use. 262801) 2623(h) This document is intended for the exclusive use ofthe rec'picntt's} named above. It may contain sensitive information that is protected privileged. or Con?dential. and it should not be disseminated. diSIributed. or copied to persons not authorized to receive such information. if you are not the intended rectpientisj, any dissnmination, distribution, or copying is strictly prohibited. ifyou think you have received this document in error, please notify the sender irnrnetllately and destroy the origiml. use. 2 62a 262a use. 2e2arh) I use. 2 use. 2.62%) As an alternative to initiating saspensi-on""or revocation proceed in select Agent Program is willing-"tiff allow thel Ito participate DSAT Performance Improvement Plan Program which will allow thel to continueitsciirrent registration as ?storage only? under the following conditions: thel l: 1. will provide to DSAT written assurance that no select agent work or activities, including transfers, will be performed or conducted until completion of the 2. will provide to DSAT a written performance improvement plan describing how Iwill resolve the discrepancies identi?ed during the February 1849, inSpection within 60 days of receipt of this letter; 262a(h) understands that APHIS and DSAT will use the entity?s written plan to monitor and provide technical assistance to assist thel to come into compliance with the 4. will resolve, not later than July 6, 2010, all discrepancies identi?ed in the attached inspection report (Attachment and, 5. will provided to DSAT a written con?rmation once all of the discrepancies identi?ed in the February 18 19 2010 inspection report have been corrected. Li) Iagree to participate in the DSAT PIPP, you are reminded that DSAT and APHIS retain the authority to conduct unannounced inspections to ensure compliance with the Select Agent regulations, and that a DSAT inspector team will be scheduled to conduct a veri?cation site visit prior to your successful completion of the and a return to full registration. Please provide us in writing a response to this letter by close of business on March 15, 2010. 3)_42 3.0. Compliance Of?cer with the nsar regarding this correspondence. we Robbin Weyant, CAPT, USPHS Director Division of Select Agents and Toxins Of?ce of Public Health Preparedness and Reaponse This document is intended for the exclusive use of the rec'piends) named above. It may contain sensitiw infonnation that is protected, privileged, or con?dential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipiends), any dissemination, distribution, or copying is strictly prohibited. lfvou think you have received this document in error, please notify The sender immediater and destroy the original. P2 DEPARTMENT OF HEQLTH AND HUMAN SERVICES Public Health Service 3an Centers for Disease Control him and Prevention (CDC) Atlanta GA 30341-3724 January 19, 2010 (more U.S.C. 26 (in December 15-17. 2009. the following representatives from Centers for Disease Control and Prevention (CDC). Division of Select Agents and Toxins (DSAT) performed a site visit {b)[3)242 '10 26 3 compliance with the select agent regulations (42 Part T3): I (b hull .. durj 11g 1hr; 5,119 511 '4 Based on observations noted during the December 15-17. 2009 inspection, the has the following 030(3): 2 signi?cant Concerns .. Ito mm of 42 CFR 73: -- Idoes not appear to have the appropriate U.S.C. 26 administrative oversight ofselect agent activities by the Responsible Of?cial. Speci?cally: 0 Plans had not been updated or reviewed to reflect corrections to departures noted during the Facility Sin: Visit .. I U.S.C. 26 March 10-11, 2009 inspection, as follows: securityr plan (eight departures remained uncorrected); incident response plan (three departures remained uncorrected}; and biosafcty plan (twenty three departures remained uncorrected). I The roles and responsibilities could not be clearly determined from interviews conducted with the Responsible Of?cial, Alternate Responsible Of?cials, Principal investigators, and laboratory workers. Speci?cally, inspectors could not determine who was responsible for assigning and removing access to select agent laboratories. Inspectors determined that access cards of individuals who had previously left employment had been used on nine occasions over the last three years. i lack training was noted during the March 10-1 1, 2009 inspection and was also noted during the December 15?17, 2009 inspection. The April 28, 2009 response fro-~- ?Edi-gated that Exams had baa? provid?d 8.0. 26 three individuals, two who were SRAwapprovctl, but there was no documentation oi" these exams provided to the DSAT inspectors on December l5-17, 200?). in addition, one of the Principal Investigators had not been tit tested for respirator use For 2009, but had been working in the select agent registered laboratory throughout the year. 2. Inspectors determined that the inventory system currently used b3] . lcould not be easily audited. Further, several vials dated March 17, 2009 El?sg?g 25 that had not been entered into the inventory were found in the freezer housing the recorded select I agent inventory. 2625015? 3. I lhas provided false statements to DSAT. The I provided a letter to signed by the anc dated April 28. 2009 indicating that the security, (b)[3)242 response, ancb-iosa fety plans had been updated and reviewed to reflect all changes from the March inspection. 2 62 a inspects-each facility to ensure that it meets the appropriate safety and securitystandards, as record?kccping requirements found in 42 CFR 73 (Possession, Use and Transter oi Select Agents 262.6101) and learns). Attachment 1 summarizes the observations and recommendations from the site visit conducted December 15-12, 2009. Provide a detailed response to this of?ce within 30 calendar days of receipt ot? this letter and send an electronic copy to the lead inspector. 'l'he will conduct a site visit lbll3li42 ill I, either announced or unannounced, to verify use Z?complianeeuwith 42 era 73. lb)l3)i42 is willing able to take corrective actions to achieve compliance 42 72 may result in the suspension of the certi?cate of registration. bbin Weyant. CAPT, USPHS irector, Division of Select Agents and Toxins Office of Public Health and Preparedness Response If you have questions concerning this correspondence, please contactl This document is intended for the exclusive use of the reeipientts] named above. It may contain sensitive information that is protected, privileged, or con?dential. and it should not be disseminated, distributed, or copied to persons not authorized to receive such mien-nation. if you are not the Intended recipientls], any dissemination, distribution. or copying is strictly prohibited. If you think you have received this document in error. please notify the sender immediately and destroy the original. ttp>3t42 use. 26 use. 26 use. 26 P3 (It qt. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Centers for Disease Control with and Prevention (CDC) 2525' Atlanta GA 30341-3724 use. . 2628(h) February 4, 2010 Subjectd a Report of Site Visit U.S.C. 262a(h) D33 On January 20-22, 2010, the following representatives from the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) performed a site visit of the [b)(3)142 U.S.C. I to ensu 262a(h) compliance with the select agent regulations (42 CFR Part 73): U.S.C. 262a(h) Individuals from present during the site visit included: .. 262a(h) 42 0 U-S-Q. 262aih) Facility -- . 3 :42 Base ono servations note uringt anuary - inspectionpt ast owmg dd 2022 2010' signi?cant concerns regarding the failure of thel Ito meet the 262mm of 42 CFR 73. Details are recorded in Attachment 1: 262mm l. 1s not conducting work select Q's-Ci agents and toxins equivalent to the minimum national safety standards as specified 2623(h) ?dition of the BMBL which provides guidelines to ensure the safety of the employees and the personnel have not followed the policies and procedures lSecurity Plan which restricts access?t'o thel ??lm-42 Ito those personnel with Security Rislg..A'ssessment (SBA) clearance. The unauthorized access is a violation of 42 CFR 2625101) Res onsible Of?cial for thel Is not rovidin the i3 ibii3ii42 that are speci?ed in 42 CFR 73.9. provided to the U.S. Government false 262aih) statements in a letter dated February 23, 2007, and signed by the Responsible Of?cial, $?3g24?2 ?what de?ciencies noted in the February 12, 2007 in5pection report had been corrected. 2623lii) The DSAT inspects each facility to ensure that it meets the appropriate safety and security standards, as well as record-keeping requirements found in 42 CFR 73 (Possession, Use and Transfer of Select Agents ?gsg'42 and Toxins). Attachment 1 summarizes the observations and recommendations from the site visit 3 _42 262' conducted January 20-22, 2010. Provide a detailed response to this office within 30 calendar days of (U ai' this letter and send an electronic copy to the lead inspector. The DSAT will conduct a site visit 262a . at thel l. either announced or unannounced, to verify compliance (b)(3)242 with 42 CFR 73. UQSJC. Continued failure to demons I is willing or able to take corrective actions to achieve compliance 42 CFR 72 may result in the suspension of the certi?cate of registration. If you have questions concerning this correspondence, pleas contactl I Robbin Weyant, T, SPHS - Director, Division of Select Agents and Toxins Office of Public Health and Preparedness Response This document is intended for the exclusive use of the recipientts} named above. It may contain sensitive inlormation that is protected. privileged, or con?dential. and it should not be disseminated. distributed. or copied to persons not authorized to receive such information. it you are not the intended recipientts}. any dissemination. distribution. or copying is strictly prohibited. If you thinlt you have received this document in error, please notify the sender immediately and destroy the original.