Lawmakers Continue to Press NIH, FDA on Lab Safety

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May 19 — Lab safety issues continue to draw concern from a House panel, which raised questions about adequate funding and management in letters released May 19.

The letters to the heads of the Food and Drug Administration and the National Institutes of Health came out about a month after the House Energy and Commerce Oversight Subcommittee held a hearing on laboratory safety, during which lawmakers grilled health officials about policy gaps in federal agencies' handling of highly toxic substances (10 LSLR 09, 4/29/16).

In their letter, Energy and Commerce Chairman Fred Upton (R-Mich.) and Rep. Tim Murphy (R-Pa.), who is chairman of the panel's oversight and investigations subcommittee, acknowledged that the Department of Health and Human Services has taken the initial steps to address laboratory safety. These steps include establishing the Office of Laboratory Science and Safety at both the FDA and the Centers for Disease Control and Prevention, and the NIH's Division for Occupational Health and Safety.

“Laboratory safety and security should be one of the highest priorities for federal departments and agencies,” Upton and Murphy wrote in both letters. “Given the importance of this critical mission area, these appropriate offices at CDC, FDA and NIH should have adequate resources, a direct report to the agency head, and be operated and funded independently of other program management activities.”

NIH Letter

The letter to NIH Director Francis S. Collins said the $15 million dedicated to lab safety at the agency appears to be adequate. But they questioned why the NIH hasn't centralized its lab safety processes and procedures and said laboratory safety standards throughout the agency were neither uniform nor consistent.

“[T]he organization of NIH’s laboratory safety management function raises questions as to whether use of these resources is economical and could be made more effective,” the NIH letter said.

Upton and Murphy asked Collins to respond by June 1 to questions on NIH lab safety improvement efforts, including:

  •  justifications for how the agency funds and deploys personnel for its lab safety programs;
  •  whether Collins agrees with recommendations from a CDC laboratory safety working group for centralized oversight of laboratory safety and to make funding for the effort independent from the NIH's 27 institutes and centers; and
whether the NIH commits to producing written reports on its investigations of lab safety problems to the House Energy and Commerce Committee, making the lab safety director report directly to Collins, and issuing written procedures for how to store and transport highly toxic agents.


The NIH told Bloomberg in an e-mail that the agency “has received the letter and will be responding directly to the Chairmen.”

FDA Letter

The letter to FDA Commissioner Robert M. Califf focused on funding. According to the letter, the FDA has yet to formulate a budget request for the agency's laboratory safety office, nor has the agency addressed adequate staffing.

“Given the critical importance of this mission and to ensure the safety of the FDA's laboratory scientists and securing biological agents and toxins, the funding associated with these offices and associated programs should come from a direct source and not through competing sources with other agency missions or priorities,” the letter said.

Murphy and Upton asked Califf to respond to several questions by June 1, including whether he will commit to a level of funding and staffing for the FDA's laboratory safety office in fiscal year 2017. They also asked questions similar to those sent to the NIH on committing to annual reports and procedures for transporting toxic agents.

The hearings and letter relate to several lapses in biosafety at federal agencies over the past several years:

  •  In July 2014, vials of smallpox likely dating back to the 1950s were discovered in an unused storage room that was leased to the FDA on the NIH campus in Bethesda, Md. (8 LSLR 673, 7/11/14).
  •  In July 2014, the House oversight panel held a hearing following the unintentional exposure of lab workers to potentially viable anthrax and highly pathogenic H5N1 bird flu virus at the CDC (8 LSLR 730, 7/25/14).
Last year, the subcommittee grilled witnesses following the discovery that live anthrax samples were distributed by a Department of Defense facility to nearly 200 research labs (8 LSLR 730, 7/25/14).


To contact the reporter on this story: Jeannie Baumann in Washington

To contact the editor responsible for this story: Randy Kubetin

For More Information

The House Energy and Commerce letters are available at