E&C Republicans Probe Biosafety Practices, Request Information from CDC and USDA Regarding Federal Select Agent Program
Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, today wrote letters to the Centers for Disease Control and Prevention and U.S. Department of Agriculture. The letters come as part of the Committee’s ongoing investigation into federal laboratory biosafety practices, and the handling of dangerous pathogens in bioresearch.
“Committee is investigating the safety and security of federal high-containment laboratories. We are writing to obtain further details about the performance and enforcement of the federal select agent program (FSAP), jointly managed by the CDC/Center for Preparedness and Response/Division of Select Agents and Toxins (DSAT), and the U.S. Department of Agriculture (USDA)/Animal Plant Health Inspection Service (APHIS)/Veterinary Services/Agriculture Select Agent Services.”
- At an April 27, 2023, oversight hearing titled “Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety,” Members and witnesses discussed the FSAP and how to strengthen the oversight of safety in life sciences labs.
- According to the seven published FSAP Annual Reports from 2015 – 2021:
- The FSAP conducted 1,316 inspections: 173 by the Agriculture Select Agent Services, 857 by the Division of Select Agents and Toxins, and 286 joint inspections by CDC’s DSAT and USDA’s APHIS
- The FSAP conducted 46 compliance inspections
- 17 entities participated in the FSAP Corrective Action Plan program
- The FSAP made 20 referrals to the HHS OIG and/or the Animal and Plant Health Inspection Service Investigative and Enforcement Services
The Chairs requested documents and answers to questions, including the following, by September 29, 2023:
- Please provide copies of all referrals the FSAP has made to the Department of Health and Human Services (HHS) Office of Inspector General and/or APHIS Investigative and Enforcement Services since January 1, 2015. Please provide the outcomes of these referrals.
- According to the 2020 Annual Report, FSAP received one report involving a complaint about transportation issues that were unrelated to the SAR. FSAP referred this complaint to the Food and Drug Administration and the Department of Transportation. Please provide a copy of this referral. Please provide the outcome of this referral.
- Please provide copies of all FSAP compliance inspections conducted at laboratories at FDA, NIH, and CDC since January 1, 2015.
- Since January 1, 2015, please list all entities levied civil money penalties as a result of FSAP enforcement actions, the nature of the violations, the kinds of pathogens involved, amount of the penalties, and the total amount of civil money penalties collected. Did any federal government entity have SAR violations that would have subjected a non-federal entity to civil money penalties? If so, which ones, and why were civil money penalties not levied?
- For 2015-2021, the FSAP reported conducting 1,316 inspections. How many of those inspections were unannounced inspections?
- Since December 22, 2022, has there been a release, loss, or theft of an agent or toxin listed as a federal select agent from or within a laboratory facility owned or operated by the HHS, or any other Federal laboratory facility?
- If so, was there a notification to this committee or the Committee on Health, Education, Labor and Pensions of the Senate no later than 72 hours after such event was reported to the HHS Secretary, including (1) the Federal laboratory facility in which such release, loss, or theft occurred; (2) the circumstances of such release, loss, or theft? If not, why not?
- Not later than 14 days after such notification to the committees, was an update provided to the committees on (1) any actions taken or planned by the HHS Secretary to mitigate any potential threat such release, loss, or theft may pose to public health and safety; and (2) any actions taken or planned by the HHS Secretary to review the circumstances of such release, loss, or theft, and prevent similar events.
CLICK HERE to read the full letter.