Poetic Service Centers for Disease Centre! and Prevention (CDC) Atlanta GA 30333 July 29, 2015 U.S. OE: ANS HUMAN SHEVICES The Honorable Diana DeGette Ranking Member Subcommittee on Oversight and Investigations Committee on Energy and Commerce .8. House of Representatives Washington, DC 20515 Dear Representative DeGette: Thank you for your letter requesting information related to enforcement of the Federal Select Agent Program. CDC remains to this important issue and to protecting the health of our nation. Please find enclosed responses to the speci?c questions raised in your letter. If you have any questions please have your staff contact Ms. Barbara Rogers in the CDC Washington Of?ce at (202) 245?0600 or BRogers@cde.gov. This response is also being sent to the co-signers of your letter. Sincerely, Thomas R. Frieden, MD, MPH Director, CDC Enclosure Centers for Disease Control and I'revention?s (CDC) Responses to the House Committee on Energy and Commerce questions regarding enforcement of Federal Select Agent Program (FSAP) - July 14, 2015 1. How many referrals has CDC made to OIG for FSAP enforcements actions? Since 2003, when the enforcement provisions were added to the U.S. Department of Health and Human Services (HHS) select agent regulations, Division of Select Agents and Toxins (D SAT) has made 79 referrals to the HHS Office of Inspector General (HHS-GIG) for alleged violations of select agent regulations. FSAP is a collaborative effort of and Animal and Plant Health Inspection Service, Agriculture Select Agent Services uses a different procedure to seek civil penalties. 2. How many entities were referred to 01G for potential FSAP enforcement action? Since 2003, DSAT referred 68 entities to HHS-01G for alleged violations of HHS select agent regulations. 3. How many entities were levied eivil money penalties as a result of the FSAP enforcement action, and what was the total amount of civil money penalties collected? Were any of these federal government entities? If so, which ones?I Since 2003, HHS-01G has levied over $2,414,000 in civil monetary penalties against 20 entities for violations of HHS select agent regulations. Ne federal government entity has been fined. We note that these enforcement actions were a result of referrals from as mentioned in response no. 1, FSAP is a collaborative effort of DSAT and uses a different procedure to seek civil penalties. 4. How many entities had multiple FSAP referrals? Please list the entities. Since 2003, the following entities have been referred more than once by DSAT to for violations of the HHS select agent reguiations: use. 262a(h) i GO 0 5. How many entities had multiple SAP violations? Please list the entities. Of the 68 entities that were referred to HHS-016 for an enforcement action, 23 entities had more than one regulatory violation cited in the referral: [0:13:42 USE. 252301} 1' (3 violations) use. 2732 . . i a (3 violations) How many entities were kicked out of the Please list the entities, and explain use. 262a(h) (2 violations) );42 use. 262a(h) ):42 use. 262a(h) ):42 U.S.C. 262a(h (h (W3 (no b)(3 42 use. 262a V10 3. (W3 0115 )z42 use. 262a(h) use. 262a(h) use. 262a(h) violations) 3):42 U.S.C. 2628(h) ations l(2 violations) 3);42 use. 262a(h) 2 violations) use. 262a(h) use. a 262a(h) violations) (2 violations) use. 262a(h) violations) tbll3li42 U.S.C. 2628thl violations) rmr3r42 use. a 262athi K4 violations) mam-49 l] 8 769mm [6 violation liivolving 2 3 violations) (3 2 violations) (2 violations) 3 violations) 9) use. 262a(h) (2 violations) use. 262a(h) why these entities were kicked out of the FSAP. Since 2003, DSAT has revoked the registration for the possession, use, and transfer of select agents and toxins for the following two entities: 9 use. 262a(h) No administration oversight regarding select agent activities. use. 262a(h) 0 Failed to show adequate progress in addressing regulatory nonhcomplianoe during their participation in the DSAT Performance Improvement Pian Program; and 0 Serious de?ciencies with regard to failure of the entity's Responsible O?icial to provide administrative oversight to ensure compliance with the seleet agent reguiations. How many entities are or were suspended from doing any select agent research? Please list the entities and explain why each of these entities was suspended, the periott of suspension, and the reason for reinstatement. Since 2003, DSAT suspended the following ?ve entities? registrations: Entity Name Reason for Suspension Period of Suspension Reason for Reinstatement (b)(3)342 U533. Einsafety, security, and SNKUQ 1/2211l it] Successfully completed 262a(h) oversight concerns Performance Improvement Plan Program Biosaf?ety, security, and em W07 2f20f09 Successfully resolved oversight concerns t'egttlater}r de?ciencies Biosafety concerns 2f1r'15? Biosai'ety, security, and 3192Success?iily completed oversight concerns Performance im pro vcment Plan Program Security and oversight mil-411 32 concerns 8. How many entities are under a performance improvement plan? Please list the entities and explain why the entities were under a performance improvement plan. The Performance Improvement Pian Program has been recently ire-designated as the Corrective Action Plan (CAP) program. Currently, the following 4 entities are engaged in the CAP program and continue to work with DSAT to meet their CAP goais: use. 262a(h) Svstemio lnosa?etv and secur'ty deficiencies . U.S.C. 2628(h) 0 with Tier I select aoent "requirements use. 262a(h) 0 Systemic bios afetv and security deficiencies U.S.C. 262a(h) Non-compliance with Tier 1 select agent requirements 1 Entitv remains sustaended from the program. 1 Entity withdrew registration from the program 9. Please provide a chart detailing the cases in which civil money penalties were levied or other enforcement actions imposed, including the following information: name of the entity, date of the violation, amount of the fine, whether the fine was actually collected or other type of enforcement action imposed, and nature of the violation. Since 2003, HHS-01G has imposed civil money penalties and levied over $2,414,000 against 20 entities listed below for violations of HHS select agent regulations. CDC recommends contacting HHS-01610 coniirrn whether ?nes were collected: Civil Whine}.r ?titv Alleged Violation Date Referred Penalties 08.0. Possession ofSA 42 can. 0 710(c)(1) 1212212004 $15,000 2623(h) Biosafety, security, and oversight concerns 812701009 $50,000 ?73.9, and Inventory and oversight concerns {?73.9 1211/20} 1 $50,000 and 73.17) Failure to comet}.r with applicable laws 1011912005 $45 0,000 regarding packaging and shipping (42 (AER. 71160)) and allowed unauthorized access (73.11) Possession of SA 42 C.F.R. 911022003 $50,000 Transfer violation 42 C.F.R. 7314 9} 14(2004 $20,000 Biosat?ety, records and oversight concerns 61312010 $165,000 @719, $3.12 and Possession ofSA 42 ORR. 604.0004 $12,000 Transfer violation (ll-Ill. $3.16) 21'101'2000 $25 ,0 00 Transfer violation (42 C.F.R. ?73.16} 11114f200?i' $1 10,000 Securit}.r and oversight concerns {?73.9 1011612009 $=10,0 00 and Transfer violation (42 CPR. 16) 519512010 $25,000 Training 'l?ransfer violation 42 C.F.R. ?if9t2004 $150,000 73.14 Biosafety, security, and oversight concerns 61'71'2007 $1,000,000 as a result of occupational exposure ?73.11 and $3.12) I Possession of unregistered select agents 50512005 $50,000 (42 C.F. R. 73.700) and possibie transfer violation (42 C.F.R. 73.16) Allowed unauthorized access to select 232301009 $47,000 agents which violated the requirements set forth in ?73.10(a) and ?73.l i Transfer violation 42 C.F.R. 73.14 91?141'2004 $15,000 Entitv use. 262a(h) Alleged Violation Date Referred Civil Money Penalties Possession of urn?egistered select agents {42 C.F. R. 71761)), ailowed unauthorized access (-12 R. 73.1 through and biosafety eoneerns 73.12) 11f9f2005 $50,000 Entity allowed a Principal Investigator to conduct restricted experiments without obtaining prior approval ?'om Program (42 79912008 $40,000 Allowed unauthorized access to select agents which violated the requirements set forth in ?T3.10(a) and 4i 31200? $50,000 10. How many referrals for possible FSAP criminal investigation has CDC made to the Federal Bureau of Investigation Does CDC receive an}.r information from the FBI about the outcomes of these referrals? If yes, what were the outcomes of these referrals? Since 2003, DSAT has made 55 referrals to the FBI requesting further investigation. The FBI noti?es DSAT of the outcomes of the referrals. To (late, no referrai to the FBI has resulted in criminal prosecution. Politic HeaEth Serviee Centers tor Disease Centre! and Prevention Attanta GA 30333 July 29, 2015 The Honorable Tim Murphy Chairman Subcommittee on Oversight and Investigations Committee on Energy and Commerce US. House of Representatives Washington, DC 20515 Dear Mr. Chairman: Thank you for your letter requesting information related to enforcement of the FederaE Select Agent Program. CDC remains committed to this important issue and to protecting the health of our nation. Please ?nd enclosed responses to the speci?c questions raised in your letter. If you have any questions please have your sta ff contact Ms. Barbara Rogers in the CDC Washington Of?ce at (202) or HRogers@edc.gov. This response is also being sent to the eo-signers of your letter. Sincerely, WW Thomas R. Frieden, MD, MPH Director, CDC Enclosure Centers for Disease Control and Prevention?s (CDC) Responses to the House Committee on Energy and Commerce questions regarding enforcement of Federal Select Agent Program (FSAP) July 14, 2015 1. How many referrals has CDC made to OIG for IFSAP cnforeements actions? Since 2003, when the enforcement provisions were added to the US. Department of Heaith and Human Services (HHS) select agent regulations, Division of Select Agents and Toxins (DSAT) has made 79 referrais to the HHS Office of eetor General (HHS-DIG) for alleged violations of select agent regulations. FSAP is a collaborative effort of DSAT and Animal and Plant Health inspection Service, Agriculture Select Agent Services uses a different procedure to seek civil penalties. 2. How many entities were referred to 01G for potential FSAP enforcement action? Since 2003, DSAT referred 68 entities to for alleged violations of HHS select agent regulations. 3. How manyr entities were levied civil money penalties as a result of the FSAP enforcement action, and what was the total amount of civil money penalties collected? Were any of these federal government entities? If so, which ones? Since 2003, HHS-01G has levied over $2,414,000 in civil monetary penalties against 20 entities for violations of HHS select agent regulations. No federai government entity has been fined. We note that these HHS-GIG enforcement actions were a result of referrals from DSAT. As mentioned in response no. i, FSAP is a collaborative effort of DSAT and uses a different procedure to seek civil penalties. 4. How many entities had multiple referrals? Please list the entities. Since 2003, the following entities have been referred more than once by to HHS-DIG for violations of the HHS select agent regulations: use. 262a(h) a a 5. How many entities had multiple FSAP violations? Please list the entities. Of the 68 entities that were referred to HHS-01G for an enforcement action, 23 entities had more than one regulatory violation cited in the referral: U.S.C. 252aih} violation-S) U.S.C. 2523th Violations) a use. 262a(h) 10m to 3 violations) 3):42 U.se. 262a(h) (3 referrals involving 2 use. 262a(h) use. 262a(h) violations] i3 violations) Io violati one} use. 262a(h) [2 vioiations) {blf3l'42 8 ZEZathl lt4 violations] use. 262a(h) i(2 violations) use. 262a(h) (3 violations) I'hlm?l'd? II 8 9e92th I violations} 0 a a 0 use. 2e2a(h) (2 use. 262a(h) use. 2e2a(h) I 3 violations] (bll3li42 U-S-C- 252300 (2 violations) tbgt3ll42 U.S.C. 262a(h) ibil?3l'42 2628(hl violations K2 violations) [2 violations) I4 violations) violations) use. 262a(h) lt4 violations (b (3 -42 use. 262a(h) (6 violations) 42 use. 262a(h) violations) 00.0.0006. 42 use. 262a(h) 6. How many entities were kicked out of the Please list the entities, and explain nth}r these entities were kicked out of the FSAP. Since 2003, DSAT has revoked the registration for the possession, use, and transfer of select agents and toxins for the following two entities: use. 262a(h) No administration oversight regarding select agent activities. U.S.C. 262a(h) railed to show adequate progress in regulatory non?eornphance during their paiticipation in the DSAT i?erfonnanee Improvement Plan Program; and 0 Serious de?ciencies with regard to failure of the entity?s Responsible Oi??eial to provide administrative oversight to ensure compliance with the seieet agent regulations. 2' 7. How many entities are or were suspended from doing an}r select agent research? Please list the entities and explain why each of these entities was suspended, the period of suspension, and the reason for reinstatement. Since 2003, DSAT suspended the following ?ve entities? registrations: Entity Name Reason for Suspension Period of Suspension Reason for Reinstatement (b)(3)242 U.S.C. Biosafety, security, and 8t7f09 lf21t10 Success fully completed 2528(h) oversight concerns Performance Improvement Plan Program Biosafety, security, and 6f3tlr?07' 2J2 Dt09 Success fully resolved i oversight concerns regulatory do fieieneies concerns 2t1f15' Biosat?ety, security, and 31910 ll:r 1am Success fully completed oversight concerns Performance Improvement Plan Program Security and oversight 21'142?132 concerns 8. How many entities are under a FSAP performance improvement plan? Please list the entities and explain why the entities were under a performance improvement plan. The Performance Improvement Plan Program has been recently re-designated as the Corrective Action Plan (CAP) program. Currently, the following 4 entities are engaged in the CAP program and continue to work with DSAT to meet their CAP goals: use. 262a(h) 1. ecurity de?ciencies a U.S.C. 262a(h) Non-compliance with Tier 1 select agen' requirements . U.S.C. 262a(h) 0 Systemic biosafety and security de?ciencies a U.S.C. 262a(h) Nonhcompliance with Tier 1 select agent requirements 1 Entity remains suspended from the program. 2 Entity withdrew registration from the program 9. Please provide a chart detailing the cases in which civil money penalties were levied or other enforcement actions imposed, incinding the following information: name of the entity, date of the violation, amount of the fine, whether the fine was actuthr collected or other type of enforcement action imposed, and nature of the violation. Since 2003, HHS-016 has imposed civil money penalties and levied over $2,414,000 against 20 entities listed below for violations of HHS select agent regulations. CDC recommends contacting HHS-01G to con?rm whether lines were collected: Civil Money Entity Alleged Violation Date Referred Penalties U.S.C. Possession of SA 42 C.F.R. 1212212004 $15,000 2628(h) . . Biosai?ety, security, and oversight concerns 812772009 $50,000 $013.9, 503.11 and I Inventory and oversight concerns @3733 12f1{2011 $50,000 and ?_73.17) Failure to comply with applicable laws 10! 190005 $450,000 regarding packaging and shipping {42 GER. 7116(0) and allowed unauthorized access (73.11) Possession ofSA 42 CPR. 900.0003 $50,000 Transfer violation 42 GER. 73.14 9l14l'2004 $20,0 00 Biosafety, records and oversight concerns 61312010 $105,000 ?13.l2 and $3.17) I Possession of SA 42 C.F.R. 611410.004 $12,000 Transfer violation (42 CPR. $3.16} 21'101'2000 $25,000 Transfer violation GER. ?73.16} 10143007 $110,000 Securin and oversight concerns @719 1612009 $40,000 and ?73.l 1) Transfer violation (42 C.F.R. ?13.16) Sl25l2010 $25,000 Training 'l?ransfer violation 42 GER. 7l9f2004 $15 0,000 73.14 Biosat?ety, security, and oversight concerns 6(712007 $1,000,000 as a result of occupational exposure ?73.11 and ?73.12] Possession ofuru?egistered select agents 9f5l2006 $50,000 (42 OF. R. and possible transfer violation (42 C.F.R. 73.16) Allowed unauthorized access to select 2123352009 $41,000 agents which violated the requirements set foitli in and Transfer violation GER. 73.14 911422004 $15,000 Civil Mono)r Entity Alleged Violation Date Referred Penalties (b)(3)242 U.S.C. Possession of unregistered select agents 11(912005 $513,000 g?gam) (42 (1F. R. ailoweti unauthorized access (42 CF. R. 1(dj(l) through and biosafety _e_oncerns (42 GER. 73.12) conduct restricted experiments without obtaining prior approval from Program (42 GER. Entity allowed a Principal Investigator to 7129:2003 $40,000 Ailoweti unauthorized access to select 41181200? $50,000 agents which violated the requirements set forth in ?73.10(a} and .10. How many referrals for possible FSAP eriminal investigation has CDC made to the Federal Bureau of Investigation Does CDC receive any information from the FBI about the outcomes of these referrals? If yes, what were the outcomes of these referrals? Since 2003, DSAT has made 55 referrals to the FBI requesting further investigation. The FBI noti?es DSAT of the outcomes of the referrals. To date, no referral to the FBI has resulted in criminal prosecution. a? . - 1, LLS. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service 4' no ill-"To .9 Centers for Disease Control and Prevention (CDC) Atlanta GA 30333 Juiy 29, 2015 The Honorable Frank Pallone, Jr, Ranking Member Committee on Energy and Commerce .3. House of Representatives Washington, DC 20515 Dear Representative Pallene: Thank you for your letter requesting information related to enforcement of the Federal Select Agent Program. CDC remains committed to this important issue and to protecting the ileaith of our nation. Please ?nd enclosed responses to the specific questions raised in your letter. if you have any questions please have your staff contact Ms. Barbara Rogers in the CDC Washington Office at (202) 245-0600 or BRogers@ccle.goy. This response is also being sent to the of your letter. Sincerely, WW Thomas R. Frieden, MD, MPH Director, CDC Enclosure Centers for Disease Control and Prevention?s (CDC) Responses to the House Committee on Energy and Commerce questions regarding enforcement of Federal Select Agent Program (FSAP) - July 14, 2015 1. How many referrals has CDC made to OIG for enforcements actions? Since 2003, when the enforcement provisions were added to the US. Department of Health and Human Services (HHS) select agent regulations, Division of Select Agents and Ton ins (DSAT) has made 79 referrals to the HHS Of?ce of Inspector General (H for alleged violations of select agent regulations. SAP is a collaborative effort of DSAT and Animal and Plant Health Inspection Service, Agriculture Select Agent Services uses a different procedure to seek civil penalties. 2. Howlinany entities were referred to' DIG for potential FSAP enforcement action? Since 2003, DSAT referred 63 entities to HHS-01G for alleged violations of HHS select agent regulations. 3. How many entities were levied civil moneyr penalties as a result of the SAP enforcement action, and what was the total amount of civil mono}r penalties collected? Were any of these federal government entities? If so, which ones? Since 2003, has levied over $2,414,000 in civil monetary penalties against 20 entities for violations of [1118 select agent regulations. No federal govenunent entity has been ti ned. We note that these HHS-01G enforcement actions were a result of referrals from DSAT. As mentioned in response no. 1, FSAP is a collaborative effort of DSAT and uses a different procedure to seek civil penalties. 4. How many entities had multiple FSAP referrals? Please list the entities. Since 2003, the following entities have been referred more than once by DSAT to HHS-01G for violations of the ill-IS select agent regulations: use. 262a(h) 5. How many entities had multiple FSAP violations? Please list the entities. Of the 68 entities that were referred to HHSHOIG for an enforcement action, 23 entities had more than one regulatory violation cited in the referral: [bjf3ji42 U.S.C. 252cm: . . 1* violations) regain; vigil-aligns) :42 use. 262a(h) 7 vinlatinne?l use. 2e2a(h) (3 violations) 1 U.S.C. 262a(h) violations) referrals involving 2 use. 262a(h) (3 violations) use. 262a(h) (3 violations) use. 262a(h) (2 violations) (hil?Q?rd?? 8 7H9Qih) r4 violations) use. 2e2a(h) It?? violations) use. 262a(h) tbll3l142 U.S.C. 262afhl (3 violations) If": trinialinno?l use. 2e2a(h) (2 violations) use. 262a(h) (2. violations) ram-42 2e2arm use. 2e2a(h) use. 262a(h) (2 violations) viniati 113) (2 violations) (bil3l142 U.S.C. 8 262mm [4 violations) use. 262a(h) (2 violations) use. 262a(h) b)t3):42 U.S.C. 262ath) K4 violations) It 6 violations) use. 262a(h) (2 violations) DEGOGGOQQO use. 262a(h) 6. How many entities were kicked out of the Please list the entities, and explain why these entities were kicked out of the SAP. Since 2003, DSAT ltas revoked the registration for the possession, use, and transfer of select agents and toxins for the following two entities: use. 262a(h) 0 Nn nrlininiqti'ntinn riversith reonrrlino calm-l nee-mt notioitiee use. 2e2a(h) 0 Failed to show adequate progress in addressing regulatory non-compliance during their participation in the DSAT Performance Improvement Plan Program; and 0 Serious de?ciencies with regard to failure of the entity?s Responsible Of?cial to provide administrative oversight to ensure compliance with the select agent regulations. 7. How many entities are or were suspended from doing any select agent research? Please list the entities and explain why each of these entities was suspended, the period of suspension, and the reason for reinstatement. Since 2003, DSAT suspended the following ?ve entities" registrations: Entity Name Reason for Suspension Period of Suspension Reason for Reinstatement (b)(3)142 U.S.C. Biosafety, security, and SIWDQ lifllr?lt} Successfully completed 262801) oversight concerns Performance Improvement Pian Presses}. Biosafety, security, and oversight concerns 680$? mores Success?iliy reso Eve-ii? regalatory de?ciencies Biosafety concerns ZIUISI Biosaf?ety, security, and oversight concerns Successfully completed Performance improvement Plan Program Security and oversight concerns 2(141?132 8. How many entities are under a FSAP ert?orma nee improvement plan? Please list the entities and explain why the entities were under a performance imp rovemcnt plan. The Performance Improvement l?Ian Program has been recently re-designated as the Corrective Action Plan (CAP) program. Currently, the following 4 entities are engaged in the CAP program and continue to work with DSAT to meet their CAP goals: use. 262e(h) Fivetomin hiosat'r-tv anri . use. 262a(h) secprity deficiencies use. 262e(h) 0 Systemic biosafety and security deficiencies use. 262a(h) Non-compliance with Tier I select agent requirements Non-compliance with Tier 1 setect agent requirements 2 Entityr remains suspended from the program. Entity withdrew registration from the program 9. Please provide a chart detailing the cases in which civil money penalties were levied or other enforcement actions imposed, including the following information: name of the entity, date of the violation, amount of the fine, whether the fine was actually collected or other type of enforcement action imposed, and nature of the violation. Since 2003, HHS-016 has imposed civil money penalties and levied over $2,414,000 against 20 entities listed below for violations of HHS select agent regulations. CDC recommends contacting HHS-01G to con?rm whether lines were collected: Civil Money F?ntilv Alleged Violation Date Referred Penalties U.S.C. Possession ofSA 42 OER. 12f22f2004 $15,000 2628(h) Biosafetv, security, and oversight concerns 3f2?ii2009 $50,000 ?73.li and $3.12) inventory and oversight concerns (?73.9 l2ili'20l 1 $50,000 and 73.17) Failure to comply' with applicable laws l0f1912005 $450,000 regarding packaging and shipping {42 GER. 73160)) and allowed unauthorised access 1) Possession of SA 42 CPR. 9110:2003 $50,000 Transfer violation 42 GER. 23.14 9f14i2004 $20,000 Eiosaf'ety, records and oversight concerns 6l3i?2010 $165,000 antl_?73. Possession of SA 42 GER. 6114(2004 $12,000 Transfer violation (42 C.F.R. ?73.16) 2111010006 $25,000 Transfer violation (42 CPR. $3.16) 1100200? $110,000 Security and oversight concerns @739 10060009 $40,000 and ?73.l 1) Transfer violation (42 C.F.R. ?73.16) 53232010 $25,000 Training Transfer violation 42 C.F.R. ?l9f2004 $150,000 73.13(d} S: T314 Fiiosat'ely, security, and oversight concerns $1,000,000 as a result of occupational exposure (013.9, [Hand ?73.i2} Possession of unregistered select agents 9f5i20 00 $50,000 (42 (1F. R. and possible transfer "violation (42 GER. Allowed unauthorized access to select 2i23f2009 $47,000 agents which violated the requirements set forth in ?T3.10(a) and Transfer violation 42 C.F.R. 73.14 901-02004 [5,000 use. 262a(h) Alleged Violation Possession of mn?egistered select agents (42 (1F. R. allowed unauthorized access (42 (3.13, R, 73.1 through and biosafety concerns (42 CPR. 13.12) Date Referred Civil irritate},r Penalties i 1f9!2005 $50,000 Entity allowed a Principal investigator to conduct restricted experiments without obtaining prior approval ?om Program (42 can. wane-1)) 73912003 $40,000 Allowed unauthorized access to select agents which violated the requirements set forth in ?73.10(a] and 4f13f200'? $50,000 10. How many referrals for possible SAP criminal investigation has CDC made to the Federal Bureau of Investigation Does CDC receive any information from the FBI about the outcomes of these referrals? If yes, what were the outcomes of these referrals? Since 2003, DSAT has made 55 referrais to the FBI requesting ?u'ther investigation. The FBI notifies DSAT of the outcomes of the referrals. To date, 110 referral to the FBI has resulted in criminal prosecution. Jr?pnu)?? DEPARTMENT OF HEALTH AND HUMAN SERVECES Public Health Service r4. Centers for Disease Controt and Prevention (CDC) Atlanta GA 30333 July 29, 2015 The Honorable Fred Upton Chairmen Committee on Energy and Com meree US. House of Representatives Washingtqu DC 20515 Dear Mr. Chairman: Thank you for your letter requesting information related to enforcement of the Federal Select Agent Program. CDC remains committed to this important issue and to protecting the health of our nation. Please ?nd enclosed responses to the speci?c questions raised in your letter. if you have any questions please have your staff contact Ms. Barbara Rogers in the CDC Washington Office at (202) 245-0600 or BRogcrs@cdc.goy. This response is also being sent to the (to-signers of your letter. Sincerely, MW Thomas R. MD, MPH Director, CDC Enclosure Centers for Disease Control and Prevention?s (CDC) Responses to the House Committee on Energyr and Commerce questions regarding enforcement of Federal Select Agent Program (FSAP) - uly 14, 2015 1. How many referrals has CDC made to 01G for FSAP enforcements actions? Since 2003, when the enforcement provisions were added to the U.S. Department of Health and Human Services (HHS) select agent regulations, Division of Select Agents and Toxins (DSAT) has made 79 referrals to the HHS Of?ce of Inspector General (HHS-01G) for alleged violations of select agent regulations. FSAP is a collaborative effort and Animal and Plant Health Inspection Service, Agriculture Select Agent Services uses a different procedure to seek civil penalties. 2. How many entities were referred to DIG for potential FSAP enforcement action? Since 2003, DSAT referred 68 entities to HHS-DIG for alleged violations of HHS select agent regulations. 3. How many entities were levied civil money penalties as a result of the SAP enforcement action, and what was the total amount of civil money penalties collected? Were any of these federal government entities? If so, which ones? Since 2003, HHS-01G has levied over $2,414,000 in civil monetary penalties against 20 entities for violations of ill-IS select agent regulations. No federal government entity has been ?ned. We note that these enforcement actions were a result of referrals from DSAT. As mentioned in response no. 1, FSAP is a collaborative effort of DSAT and uses a different procedure to seek civil penalties. 4. How many entities had multiple FSAP referrals? Please list the entities. Since 2003, the following entities have been referred more than once by to for violations of the HHS select agent regulations: use. 262a(h) I II I I 5. How many entities had multiple FSAP violations? Please list the entities. Of the 68 entities that were referred to HHS-016 for an enforcement action, 23 entities had more than one regulatory violation cited in the referral: . [b}[3}242 U.S.C. 252301} I Vin] ations) 'b}[3}242 U.S.C. 2?2aih} . . (3 violations) .0060. b)(3 42 use. 262a(h) l9 violations) (3 violations) It )1 use. 262a(h) use. 262a(h) (3 referrals involving 2 violations) use. 262a(h) use. 2e2a(h) violations) lt3 violations) Io use. 262a(h) (2 violations) ):42 use. 2e2a(h) lt4 violations) l(2 violations) 3 use. 262a(h) (3):42 use. 262ath) l(3 violations) I O??gu?h?i uinlatinnql use. 262ath) (2 violations) use. a 262ath) l2 violations) violations(bli3l342 U-S-C- 252301) (2 violations) tbgt3li42 U.S.C. ?2628(h) violations) use. 2e2a(h) violations) use. 262a(h) violations) tblt3lt42 U.S.C. EE- 262ath) violations) (bll3l342 U-S-C- 252301) lt4 violations) (bll3li42 U-S-C- 2523i?) (6 violations) tb)t3):42 U.S.C. 262ath) (b)(3)242 U.S.C. 26280)) 6. How many entities were kicked out of the Please list the entities, and explain why these entities were kicked out of the FSAP. Since 2003, DSAT has revoked the registration for the possession, use, and transfer of select agents and toxins for the following two entities: use. 262a(h) No administration oversight regarding seleet agent activities. use. 262a(h) i??ll?d to show adequate progress in attdressmg regulatory during their participation in the DSAT Performance improvement Plan Program; and 0 Serious deficiencies with regard to failure of the entity?s Responsible Of?cial to provide administrative oversight to ensure compliance with the select agent regulations. 7. How many entities are or were suspended from doing any select agent research? Please list the entities and explain why each of these entities was suspended, the period of suspension, and the reason for reinstatement. Since 2003, suspended the following ?ve entities? registrations: Entity Name Reason for Suspension Period ofSuspension Reason for Reinstatement (b)(3)342 USC- Biosal?ety, security, and ?ir?21flt] Successfully completed 2628101) oversight concerns Performance improvement Plan Biosafety, security, and 613 Off)? 2120;?09 Successfully resolved oversight concerns regulatory de?ciencies Biosafet)? concerns 2! If I 5' Biosal?cty, security, and 3f9lltl i If] till 0 Successfully completed oversight concerns Performance improvement Plan Program Security and oversight 2l14f132 concerns 8. How many entities are under a FSAP performance improvement plan? Please list the entities and explain why the entities were under a performance improvement plan. The Performance Improvement Plan Program has been recently re-designated as the Corrective Action Plan (CAP) program. Currently, the following 4 entities are engaged in the CAP program and continue to work with DSAT to meet their CAP goals: U.S.C. 262e(h) Svstemie hiosafetv and security deficiencies U.S.C. 262e(h) Nonncomnliance with Tier 1 select aeent reouirem . U.S.C. 2623(h) Systemic biosafety and security de?ciencies . use. 262e(h) Non-compliance with Tier 1 select agent requirements I Entity remains suspended from the program. 2 Entitv withdrew registration from the program 9. Please provide a chart detailing the cases in which civil inone}r penalties were levied or other enforcement actions imposed, including the following information: name of the entity, date of the violation, amount of the fine, whether the fine was actually coliccted or other type of enforcement action imposed, and nature of the violation. Since 2003, has imposed civil money penalties and levied over $2,414,000 against 20 entities listed below for violations of HHS select agent regulations. CDC recommends contacting HHS-01G to con?rm whether fines were collected: Civil l'rlone)r Entity Alleged Violation Date Referred Penalties Possession oi'SA 42 CPR. 12i22r?2004 $15,000 - 262a(h) I Blosafety, security, and concerns 812712009 $50,000 @719, ?T3.ll and ?73.12) Inventon,r and oversight concerns (?73 .9 12tlf2011 $50,000 and 73.17) Failure to comply with applicable laws 10(19i2005 $450,000 regarding packaging and shipping (42 C.F.R. 7116(0) and ailowcd unauthorized access (73.11) Possession of SA 42 CPR. 9f10f2003 $50,000 Transfer vioiation 42 CPR. 73.14 9f14f2004 $20,000 Biosai?ety, records and oversight concerns 6f3f20 0 $165,000 and ?73.17) Possession of SA 42 C.F.R. 730(c)(1) Gi14t2004 $12,000 Transfer violation (42 GER. $3.10} 2! 1012006 $25,000 Transfer violation {42 CPR. ?73.16} 11/142007 $110,000 Securin and oversight concerns (?73.9 10/162009 $40,000 and ?73.l l) 'l?ranst?er violation {42 (12.13.11. 5f25f2010 $25,000 Training Transfer violation 42 CPR. 7f9r'2004 $150,000 73.13(d) cit: 73.14 Biosafety, security, and oversight concerns (itia'200?t $l,000,000 as a result ofoccupational exposure {$73.11 and Possession of unregistered select agents 9519006 $50,000 (42 CF. R. and possible transfer violation {42 C.F.R. 73.i6) Allowed unauthorized access to select 2f23f2009 $47,000 agents which violated the requirements set forth in ?73.10(a) and $13.1 Transfer violation 42 CPR. T114 9040004 $15,000 Civil Money Entitv Alleged 1Violation Date Referred Penalties U-S-C- Possession ofulu'egisteretl seiect agents i ?99005 $50,000 2628(h) (ti-2 OF. R. allowed unauthorised access (42 C.F. R. T11 through and biosai'cty concerns {42 CPR. 73.]2} Entity ailowed a Principal Investigator to 7f29i2003 $40,000 conduct restricted experiments without obtaining prior approval from Program (42 CPR. Allowed unauthorized access to select 40102007 $50,000 agents which vioiated the requirements set forth in ?73.10(a) and 10. How many referrals for possible FSAP criminal investigation has CDC made to the Federal Bureau of investigation Does CDC receive any information from the FBI about the outcomes of these referrals? If yes, what were the outcomes of these referrals? Since 2003, DSAT has made 55 referrals to the FBI requesting further investigation. The FBI notifies DSAT of the outcomes of the referrals. To date, no referral to the FBI has resulted in criminal prosecution.