Department of Health and Human Services Office of Inspector General Washington, D C 202 01 FOIA Request 2015-1112 Alison Young USA Today 7950 Jones Branch Drive Mclean, VA 22102-3302 Freedom of Information Act Office Cohen Bldg, Suite 1062 330 Independence Ave., SW Washington DC 20201 September 10, 2015 Dear Ms. Young: This is in response to the July 13, 2015, Freedom of Information Act (FOIA), request you submitted to the Department of Health and Human Services (HHS), Office of Inspector General (OIG), seeking documents related to enforcement referrals regarding the select agent program relative to a USAToday June 12, 2015 article. The Office of Counsel to the Inspector General located one-hundred-eighty-seven (187) pages responsive to your request; I have determined to partially release twelve (12) pages with portion withheld under FOIA Exemption (b)(3) and withhold in full, twenty-five (25) pages under FOIA Exemptions (b)(3) & (b)(5). Exemption (b)(3) permits the withholding of records when release is exempted by another statute, 42 USC 262a(h). Exemption (b)(5) permits the withholding of internal government records which are pre-decisional and contain staff advice, opinion and recommendation. This exemption is intended to preserve free and candid internal dialogue leading to decision-making. In addition, thirty-one (31) pages originated with the Centers for Disease Control and Prevention (CDC), along with an additional one-hundred-nineteen (119) pages which originated with the Department of the Army; I have forwarded those pages to the respective agencies for review and direct response to you. Should you wish to contact those agencies, you may do so using the information below: CDC Freedom of Information Officer 1600 Clifton Road, N.E. Bldg. 57 Room MS D-54 Atlanta, GA 30333 Phone: 770-488-6399 Department of the Army U.S Army Test and Evaluation Command 2202 Aberdeen Boulevard – Third Floor Aberdeen Proving Ground, MD 21005 Phone: 443-861-9262 There is no charge for FOIA services in this instance because billable charges are below the $25 Departmental threshold. If you have reason to believe that any denied portions should not be exempt from disclosure, you may appeal. Your appeal should be mailed within 30 days from the date of this letter, to the U.S. Department of Health and Human Services, ASPA, FOI/Privacy Act Division, Suite 729H, 200 Independence Avenue, SW, Washington, DC 20201. Clearly mark both the envelope and your letter “Freedom of Information Act Appeal.” For your information, Congress excluded three discrete categories of law enforcement and national security records from the requirements of the FOIA. See 5 U.S.C. § 552(c) (2006 & Supp. IV (2010). This response is limited to those records that are subject to the requirements of the FOIA. This is a standard notification that is given to all our requesters and should not be taken as an indication that excluded records do, or do not, exist. Sincerely, Robin R. Brooks Director Freedom of Information DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General Washington, D.C. 20201 DEC - 2 2009 VIA FIRST CLASS U.S. MAIL TO D AY (b)(3) Dear (b)(3) FO IA to U SA The United States Department of Health and Human Services, Office of Inspector General (OIG), has concluded its investigation regarding (b)(3) (b)(3) alleged violation of the Select Agents and Toxins Regulations. See 42 C.F.R. Part 73. The OIG has determined that(b)(3) violated 42 C.F.R. § 73.16 by making an (b)(3) unauthorized transfer of the select agent to (b)(3) (b)(3) . vi a The Select Agents and Toxins Regulations set forth requirements regarding the possession, use, or transfer of select agents and toxins. See 42 C.F.R. § 73.2. A viable select agent cannot be transferred from one entity to another until the Centers for Disease Control and Prevention (CDC) has authorized the transfer. See 42 C.F.R. §§ 73.3 & se d 73.16. R el ea In April 2007, (b)(3) shipped the select agent (b)(3) to(b)(3) without obtaining pretransfer authorization from the CDC. The shipment was supposed to contain non-viable (b)(3) (b)(3) certified that it tested the agent's viability prior to shipment and (b)(3) found the agent non-viable. The OIG's investigation determined that the (b)(3) was (b)(3) viable at the time of shipment. performed sterility testing on the agent after receipt and identified viable (b)(3) The investigation included a comprehensive review of(b)(3) 's documentation concerning the inactivation procedure, including a copy of its Standard Operating Procedures (SOP) for inactivating biological agents and stimulants for antigen production, the principal investigator's (Pl) clinical notebook, the inactivation certificate for the sample, and a record of the validity check. The OIG, in consultation with the CDC Division of Select Agents and Toxins, has determined that, although (b)(3) 's method of inactivation (use of chlorine dioxide (Cl02)) OCIG-000001 Page 2 - (b)(3) (b)(3) (b)(3) was scientifically acceptable, did not follow its own SOP to iµactivate the (b)(3) During the time in question, had three SOPs for agent inactivation: heat, formalin, did not have a SOP for the use ofC102• The investigation and gamma irradiation. (b)(3) (b)(3) did not test the Cl02 inactivation method for efficacy prior to found that implementatioi:i. SA TO D AY Further, the PI's clinical notebook demonstrates that during viability testing, one of the five tubes containing (b)(3) to be shipped to (b)(3) tested positive for viable (b)(3) cells when a small portion was cultured in a brain-heart infusion broth. This is evidence that the inactivation procedure was ineffective. The PI' s notes do not explain why the viable colony grew, whether the inactivation procedure was performed properly, or why the remaining tubes were not retested for viability. Upon completion of the viability (b)(3) check, discarded the tube with excessive growth and issued death certificates for the remaining tubes. The remaining material was sent to (b)(3) . The (b)(3) samples to(b)(3) were of the(b)(3) strain genotype, which was the provided by (b)(3) (b)(3) same as the viable (b)(3) identified at . Therefore, the OIG has conclusively ' s viable (b)(3) determined that (b)(3) was the source of(b)(3) U (b)(3) (b)(3) (b)(3) d vi a FO IA to transferred viable to absent CDC approval, The OIG concludes that in violation of 42 C.F.R. § 73.16. Under the Public Health Security and Bioterrorism Preparedness and Response Act (Act), 42 U.S.C. § 262a, and 42 C.F.R. § 73.21, the OIG is authorized to impose a civil monetary penalty (Crv:IP) of up to $250,000 against an individual and up to $500,000 against any other person, including any entity, that is in violation of any of the requirements found in the select agent regulations. See 42 C.F.R. § 1003.103(1). Under the Act, the term "person" is defined to include, "Federal, State, and local government entities." 42 U.S.C. § 262a(l). R el ea se status as a federal Based on all of the circumstances in this matter, including (b)(3) agency, the OIG is exercising its discretion not seek a civil monetary penalty for the should examine its current above-mentioned conduct. However, the OIG believes (b)(3) practices and policies, implement effective corrective actions and safeguards to ensure that future violations do not occur, and monitor such actions and safeguards on an ongoing basis. OCIG-000002 ; Page 3 - (b)(3) In the event you wish to discuss the OIG's investigation, findings, or recommendations, please feel free to contact David M. Blank, Senior Counsel, at (202) 205-0578. Sincerely, .... . . . <=~~:> .Greg~cy- Demske l SA TO D cc: Lori J. Bane Compliance Officer, Division of Select Agents and. Toxins Centers for Disease Control and Prevention AY Assistant Inspector General for Legal Affairs Office of Counsel to the Inspector General R el ea se d vi a FO IA to U (b)(3) 42 U.S. Code § 262a(h) OCIG-000003 -.,;. VIA FIRST CLASS U.S. MAIL (b)(3) (b)(3) AY Dear SA TO D The United States Department of Health and Human Services, Office of Inspector (b)(3) General (OIG), has concluded its investigation regarding (b)(3) alleged violation of the Select Agents and Toxins Regulations. See 42 C.F.R. (b)(3) Pa...rt 73. The OIG has determined that violated 42 C.F.R. § 73.16 by making an (b)(3) unauthorized transfer of the select agent to (b)(3) U (b)(3) a FO IA to The Select Agents and Toxins Regulations set forth requirements regarding the possession, use, or transfer of select agents and toxins. See 42 C.F .R. § 73 .2. A viable select agent cannot be transferred from one entity to another until the Centers for Disease Control and Prevention (CDC) has authorized the transfer. See 42 C.F.R. §§ 73.3 & 73.16. (b)(3) (b)(3) el ea se d vi shipped the select agent (b)(3) to without obtaining preIn April 2007, transfer authorization from the CDC. The shipment was supposed to contain non-viable (b)(3) (b)(3) certified that it tested the agent's viability prior to shipment and (b)(3) found the agent non-viable. The OIG's investigation determined that the (b)(3) was (b)(3) performed sterility testing on the agent after viable at the time of shipment. (b)(3) receipt and identified viable R i (b)(3) The investigation included a comprehensive review of 's documentation concerning the inactivation procedure, including a copy of its Standard Operating Procedures (SOP) for inactivating biological agents and stimulants for antigen production, the principal investigator's (PI) clinical notebook, the inactivation certificate for the sample, and a record of the validity check. The OIG, in consultation with the CDC Division of Select Agents and Toxins, has (b)(3) ' s method of inactivation (use of chlorine dioxide (Cl 02)) determined that, although (b)(3) did not follow its own SOP to inactivate the (b)(3) was scientifically acceptable, (b)(3) During the time in question, had three SOPs for agent inactivation: heat, formalin, (b)(3) did not have a SOP for the use of Cl02. The investigation and gamma irradiation. OCIG-000004 found that (b)(3) did not test the Cl02 inactivation method for efficacy prior to implementation. TO D AY Further, the PI's clinical notebook demonstrates that during viability testing, one of the five tubes containing (b)(3) to be shipped to (b)(3) tested positive for viable (b)(3) cells when a small portion was cultured in a brain-heart infusion broth. This is evidence that the inactivation procedure was ineffective. The PI' s notes do not explain why the viable colony grew, whether the inactivation procedure was performed properly, or why the remaining tubes were not retested for viability. Upon completion of the viability (b)(3) check, discarded the tube with excessive growth and issued death certificates for the remaining tubes. The remaining material was sent to (b)(3) . The (b)(3) samples (b)(3) to(b)(3) were of the (b)(3) strain genotype, which was the provided by same as the viable (b)(3) identified at (b)(3) Therefore, the OIG has conclusively (b)(3) (b)(3) was the source of 's viable (b)(3) determined that (b)(3) (b)(3) FO IA to U SA transferred viable (b)(3) to absent CDC approval, The OIG concludes that in violation of 42 C.F .R. § 73 .16. Under the Public Health Security and Bioterrorism Preparedness and Response Act (Act), 42 U.S.C. § 262a, and 42 C.F.R. § 73.21, the OIG is authorized to impose a civil monetary penalty (CMP) of up to $250,000 against an individual and up to $500,000 against any other person, including any entity, that is in violation of any of the requirements found in the select agent regulations. See 42 C.F.R. § 1003.103(1). Under the Act, the term "person" is defined to include, "Federal, State, and local government entities." 42 U.S.C. § 262a(l). (b)(3) el ea se d vi a Based on all of the circumstances in this matter, including 's status as a federal agency, the OIG is exercising its discretion not seek a civil monetary penalty for the above-mentioned conduct. However, the OIG believes (b)(3) should examine its current practices and policies, implement effective corrective actions and safeguards to ensure that future violations do not occur, and monitor such actions and safeguards on an ongoing basis. R In the event you wish to discuss the OIG's investigation, findings, or recommendations, please feel free to contact David M. Blank, Senior Counsel, at (202) 205-0578. Sincerely, Gregory E. Demske Assistant Inspector General for Legal Affairs OCIG-000005 ., CC: Lori J. Bane, Compliance Officer, Division of Select Agents and Toxins, CDC se d vi a FO IA to U SA TO D AY (b)(3) 42 U.S. Code § 262a(h) ea ) el -;. R ,,... OCIG-000006 DEPARTMENT" OF HEALTH & HUMAN SERVICES i .Office of Inspector General Office of Counsel to the Inspector General David 1\1. Blank Associate Counsel, Administrati\'e and Civil Remedies Branch Telephone:· (202) 205-0578 . Facsimile: (202) 205-0604 330 Independence Ave., S.W Cohen Building - Room 5527 Washington, D.C. 20201 March 31, 2008 VIA FIRST CLASS U.S. MAIL (b)(3) : SA Dear TO D AY (b)(3) a FO IA to U This letter is to advise you that the Office of Inspector General (OIG) for the United States Department of Health and Human Services (HHS) has preliminarily determined (b)(3) that may have violated the Select Agent regulations, 42 C.F.R. Part 73, for its failure to properly transfer the select agent (b)(3) (b)(3) This determination is based on information the OIG has received from the Centers for Disease Control and Prevention (CDC). R el ea se d vi Part 73 of Title 42 of the Code of Federal Regulations sets forth requirements regarding the possession or use in the United States, receipt from outside the United States, or transfer within the United States, of select agents and toxins. See 42 C.F.R. § 73.2. Specifically, those regulations state that a select agent cannot be transferred from one entity to another if the CDC has not authorized the transfer before it takes place. See 42 C.F.R. §§ 73.16. (b)(3) made an unauthorized transfer of (b)(3) in violations of 42 The OIG believes that (b)(3) (b)(3) (b)(3) C.F.R. § 73.16. In April 2007, shipped the select agent to (b)(3) ·The OIG believes the (b)(3) aliquot of (b)(3) documented killed was viable. The material was determined to be viable after (b)(3) performed sterility testing on the aliquot and confirmed a low concentration of (b)(3) (b)(3) did not obtain CDC auth9rization prior to transferring the select agent to (b)(3) OCIG-000007 (b)(3) Page 2We are writing to extend to you the opportunity to provide us with additional information regarding this apparent violation before the OIG considers further action. If you wish to submit additional infonnation, please do so by May 1, 2008. You may reach me at the above address or by calling (202) 205-0578. R el ea se d vi a FO IA to U SA TO D David M. Blank Associate Counsel AY Sincerely, OCIG-000008 .I~ DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General Office of Counsel to the Inspector General David M. Blank Associate Counsel, Administrative and Civil Remedies Branch Telephone: (202) 205-0578 Facsimile: (202) 205-0604 Cohen Building - Room 5527 330 Independence Ave., SW Washington, DC 20201 Email: david.blank@oig.hhs.gov March 27, 2008 AY VIA FIRST CLASS U.S. MAIL (b)(3) U Dear SA TO D (b)(3) vi a FO IA to This letter is to advise you that the Office of Inspector General {OIG) for the United States (b)(3) Department of Health and Human Services (HHS) has preliminarily determined that (b)(3) may have violated the Select Agent regulations, 42 C.F .R. Part 73, for its failure to properly transfer the select agent (b)(3) This determination is based on information the OIG has received from the Centers for Disease Control and Prevention (CDC). d Part 73 of Title 42 of the Code of Federal Regulations sets forth requirements regarding the possession or use in the United States, receipt from outside the United States, or transfer within the United States, of select agents and toxins. See 42 C.F.R. § 73.2. Specifically, those regulations state that a select agent cannot be transferred from one entity to another if the CDC has not authorized the transfer before it takes place. See 42 C.F.R. §§ 73.16. se • ea ; el ~ R • (b)(3) (b)(3) The OIG believes that made an unauthorized transfer of in violations of 42 (b)(3) (b)(3) C.F.R. § 73.16. In April 2007, shipped the select agent (b)(3) to (b)(3) ). The OIG believes the (b)(3) aliquot of (b)(3) documented killed was viable. The material was determined to be viable after (b)(3) performed sterility testing on the aliquot and confirmed a low concentration of (b)(3) (b)(3) did not obtain CDC authorization prior to transferring the select agent to (b)(3) We are writing to extend to you the opportunity to provide us with additional information regarding this apparent violation before the OIG considers further action. If you wish to OCIG-000009 submit additional information, please do so by May 1, 2008. You may reach me at the above address or by calling (202) 205-0578. Sincerely, R el ea se d vi a FO IA to U SA TO D AY David M. Blank Associate Counsel OCIG-000010 r.· JI ··, \·~ March 31, 2008 (b)(3) .. . ;:·"'~ '• .. ,. ~·r.r'r'~:.•«:•: ..~.. . ,.,. .._. ..... ~ .. • (b)(3) SA Dear TO D AY ' .- .;. . . FO IA to U This letted$· to, advise you .that the Office of Inspector ~eneral (O~G.)' for Jh~ United States Depattmetit of.Hettith. f41·d }fumart Services.(HHS) ~~as pr~li~inatily·d~tefW:jne,tj that (b)(3) mayhave violateth:he.S·elect Ag¢ntre~[~tfol1s, 42 C.F .R. Part 7~:; for:. its failure ~t0 properly·transfer the select agent (b)(3) (b)(3) .. 'Fhis d¢tenninaHon is ·based: orr-informati.on the 'OIG.has,receivedJtt>m ;the ·Centers for Disease Control and Pteventi<>n (CDC). vi a Part-73 of Title 42 of the Code of Federal Regulations sets forth requirements regarding the possesslon oi; use in the United:States, receipt from outside the United Statesj or trari~fer Wlthirf the:'.United .States, of select agents ahd toxins~ See 42 ·C.F .R. § 73~2 . el ea se d .~~t~~~~;~~~-g~1i~~,~f~iihlttitt1ti~~~~\~rlii!.~l~~.~~~~f· (b)(3) (b)(3) The OIG believes that made an unauthorized transfer of in violations of 42 (b)(3) (b)(3) C.F .R. § 73 .16. In :April 2007, shipped the select agent to (b)(3) (b)(3) ). The OIG ·believes the (b)(3) aliquot of docwnented .k~lled (b)(3) wa8 viable. The material .was determined to be viable after (b)(3) perfomi~d:sterility testing on the aliquot and confirmed a low concentration of (b)(3) · (b)(3) did:not' obtain CDC authorization prior to transferrirtg the seleet .ag~nt to R ht>: < . . ; (b)(3) OCIG-000141 .. • - ._ \, (b)(3) ·~re, ate writing to extend to you the opportunity to provide us with additional: information te.garding this apparent violation before the OIG considers further action. Ifyg),l1:\.v\siHo submit additional information, please do so by May 1, 2008. You may reachtrte;·af.the above address or by calling (202) 205-0578. Sincerely, . ·-· R el ea se d vi a FO IA to U SA TO D Associate Counsel AY b'avi'cJ::[\.;f">B'1Ank> . .· ,.:·,.. ·•. J! •. OCIG-000142