GAO: Biocontainment Labs Still Have Safety Problems

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April 19 — Ongoing deficiencies in how federal laboratories handle hazardous biological agents require updated polices and better oversight across the government, according to an April 19 GAO report.

The Government Accountability Office report, Comprehensive and Up-to-Date Policies and Stronger Oversight Mechanisms Needed to Improve Safety (GAO-16-305), follows up on incidents in 2014 and 2015 that led to potential human exposure to vials containing anthrax and smallpox (9 LSLR 620, 5/29/15). After reviewing eight departments and 15 agencies, the GAO concluded most of them had policies that weren't comprehensive, and some departments and agencies had policies that weren't up to date.

“Given the threat that hazardous biological agents pose to public and animal health and the U.S. economy, federal departments and agencies need to strengthen oversight of their high-containment laboratories,” the GAO said in the report, while acknowledging that federal reviews have made recommendations intended to strengthen federal and national oversight. “Nonetheless, we continued to find certain deficiencies in departments’ and agencies’ internal controls for the management of their high containment laboratories, as well as opportunities for improvement.”

Biosafety Hearing

The House Energy and Commerce Committee released the report the day before its Oversight and Investigations Subcommittee was scheduled to hold a hearing on biosafety. Lawmakers on the oversight panel have held hearings on biosafety following the anthrax and smallpox incidents, expressing frustration at that time (8 LSLR 730, 7/25/14).

Rep. Tim Murphy (R-Pa.), chairman of the oversight subcommittee, said in an April 19 statement that labs working with hazardous materials should have adequate procedures in place to protect the public.

“Safety lapses at our bioresearch labs have been a concern for quite some time. While I’m encouraged to hear that some improvements have been made after these lapses, the fact of the matter is that far too many have happened,” Murphy said.

33 Recommendations

The GAO made nearly three dozen recommendations, calling on departments to “develop and update policies to include missing elements, ensure that oversight activity results are reported to senior officials, and develop plans with time frames for implementing safety recommendations.”

The Department of Health and Human Services along with the Department of Defense have made progress in implementing recommendations from laboratory safety reviews but haven't developed sufficient implementation plans, the GAO said. But the GAO didn't consider the HHS to have comprehensive policies.

“HHS did not have department-level policies, and two of its three component agencies did not have all six key elements in their agency-level policies. Specifically, [the Centers for Disease Control and Prevention's] policies contained three of the six key policy elements, but policies that contained the requirements for training and inspections applied only to the agency’s select agent-registered laboratories,” the report said. “We also found that CDC’s and [the Food and Drug Administration's] policies did not contain requirements for incident reporting to senior department officials. In contrast, we considered [The National Institutes of Health’s] policies for laboratory management to be comprehensive because the agency’s policies contained all six key elements, including reporting incidents to senior department officials.”

HHS-Specific Advice

The recommendations addressed departments throughout the government, including the Agriculture, Interior, Energy, Homeland Security and Defense departments. For the HHS specifically, the report included recommendations to:

  •  direct the NIH director to review and update the agency’s outdated policies for managing hazardous biological agents in high-containment laboratories;
  •  direct the FDA commissioner to establish a regular schedule for reviewing and updating agency policies for managing hazardous biological agents in high-containment laboratories;
  •  require routine reporting of the results of agency and select agent laboratory inspections to senior department officials;
  •  direct the heads of the NIH and the FDA to require routine reporting of the results of agency laboratory inspections— and in the case of FDA, require routine reporting of select agent inspection results—to senior agency officials; and
  •  require routine reporting of incidents at CDC, FDA and NIH laboratories to senior department officials.

 

In July 2014, missteps at the CDC led to the unintentional exposure of more than 80 personnel to potentially viable anthrax and highly pathogenic H5N1 bird flu virus (8 LSLR 730, 7/25/14).

To contact the reporter on this story: Jeannie Baumann in Washington jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

The GAO report is at http://www.gao.gov/products/GAO-16-305.

More information on the House panel hearing is at http://1.usa.gov/1SOsPaY.