U.S. House Energy and Commerce (E&C) Committee Chair Cathy McMorris Rodgers (R-WA) recently led two of her committee colleagues in continuing an investigation into federal laboratory biosafety practices and the handling of pathogens in bioresearch by requesting myriad details from the Biden administration.
The E&C Committee members — who also included U.S. Rep. Brett Guthrie (R-KY), chair of the E&C Subcommittee on Health, and U.S. Rep. Morgan Griffith (R-VA), chair of the E&C Subcommittee on Oversight and Investigations — questioned the heads of two federal agencies about the safety and security of federal high-containment laboratories in a Sept. 15 letter.
Specifically, the members seek to obtain further details about the performance and enforcement of the federal select agent program (FSAP), which is jointly managed by divisions within both the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA).
Rep. McMorris Rodgers and her colleagues noted in their letter, sent to CDC Director Dr. Mandy Cohen and USDA Secretary Tom Vilsack, that more information is needed following an April 27 oversight hearing that committee members held entitled “Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety.”
Lawmakers and witnesses, who during the hearing discussed the FSAP and how to strengthen safety oversight in life sciences labs, learned about seven published FSAP annual reports from 2015 to 2021 showing that the FSAP conducted 1,316 inspections and 46 compliance inspections. Seventeen entities participated in the FSAP Corrective Action Plan program, according to the reports, and the FSAP made 20 referrals to federal investigative and enforcement services.
Seeking more details to inform the E&C Committee’s oversight of FSAP, the lawmakers requested copies of all referrals the FSAP has made to the U.S. Department of Health and Human Services Office of Inspector General and/or USDA’s Animal Plant Health Inspection Service (APHIS) since Jan. 1, 2015. They also want information about the outcomes of these referrals, according to their letter.
Additionally, “according to the 2020 Annual Report, FSAP received one report involving a complaint about transportation issues that were unrelated to the SAR [Select Agent Regulations],” they wrote, citing the regulations governing FSAP. “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.”
Among more than a dozen other all-inclusive questions and document requests, Rep. McMorris Rodgers and her colleagues asked for copies of all FSAP compliance inspections conducted at laboratories at the CDC and other federal agencies since Jan. 1, 2015, and a list of all entities levied civil money penalties as a result of FSAP enforcement actions, the nature of the violations, the kinds of pathogens involved, the amount of the penalties, and the total amount of civil money penalties collected, their letter states.