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# House GOPers ‘Concerned’ About FDA Lab Safety
- URL: https://www.fdaweb.com/house-gopers-concerned-about-fda-lab-safety/
- Published: 2023-11-02T12:00:00.000Z
- Updated: 2026-09-14T14:15:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155702

Republican members of the House Energy and Commerce Committee say they are “deeply concerned that FDA is not meeting important federal safety requirements to protect employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.” In an 11/1 [letter](https://energycommerce.house.gov/posts/e-and-c-republicans-threaten-fda-with-subpoena-in-lab-safety-investigation-agency-violating-federal-safety-rules-delays-addressing-gao-recommendations?ref=fdaweb.com) to FDA commissioner **Robert Califf**, committee Republican leaders reacted to an agency 8/21 letter that was sent in response to the committee’s 5/24 letter on lab safety.

“FDA’s letter is troubling for a number of reasons,” the Republicans say. “First, it indicates that FDA has no plans to empower the director of the Office of Laboratory Safety (OLS) by giving the position a direct reporting relationship to the commissioner and returning ‘Science’ to the title and mission of OLS. Second, your letter indicates that FDA is not complying with key federal regulations, including those of the Occupational Safety and Health Administration, on workplace safety in its research laboratories. Third, FDA’s response confirms that FDA still has not fully addressed any of the five [recommendations](https://fdaweb.com/login.php?sa=v&aid=D5147829&cate=&stid=%241%24CT0.jP4.%24SC28dFtXdMLRa2wc1FtqO%2F&ref=fdaweb.com) from the Government Accountability Office (GAO) related to FDA laboratory safety after more than three years.”

The letter outlines the committee members’ concerns with:

- direct reporting to the commissioner;
- inadequate frequency of inspection and lack of unannounced inspections;
- FDA’s failure to address the GAO recommendations on laboratory safety; and
- removal of Science from \[the\] OLS name and mission.

The 2020 GAO report called on FDA to take additional steps to strengthen efforts to provide effective lab safety oversight. It noted that its 2016 report made five recommendations, four of which were not fully implemented as of 2020\. The report recommended that FDA:

- resolve disagreements over roles and responsibilities;
- address issues of duplication, overlap, and fragmentation in the safety program;
- identify how agency leadership will communicate agency-wide on a sustained basis about the importance of lab safety and the OLS’ role in ensuring the successful implementation of laboratory safety reforms;
- provide the OLS with the authority and access to facilities necessary to oversee laboratory safety and ensure compliance with agency safety policies; and
- mitigate any independence risks posed by how OLS is funded.

Committee Republicans say that in their 5/24 letter, they requested documents from FDA that so far the agency has not produced. The letter lists the 12 sets of documents the committee wants by 11/15 and says the committee is prepared to issue a subpoena if the documents are not received by the due date so the committee can carry out its oversight responsibilities.