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Regulatory News | 20 April 2016 | By Michael Mezher
At a Congressional hearing on Wednesday, an official from the US Food and Drug Administration (FDA) said that the agency has taken "direct and definitive actions" to improve laboratory safety after a new report highlighted deficiencies at a number of federal agencies in their oversight of bioresearch laboratory safety.
The report, issued by the Government Accountability Office (GAO), comes after recent incidents involving the mishandling of dangerous biological materials, including smallpox and drug-resistant strains of anthrax and plague at high-containment laboratories operated by federal agencies.
In one instance in 2014, an FDA researcher discovered twelve "overlooked" boxes which contained 327 laboratory samples, six of which contained Variola, the virus that causes smallpox.
In addition to the GAO report, Republican members of the House Energy and Commerce Oversight and Investigations subcommittee conducted their own investigation into FDA, the National Institutes of Health (NIH) and Centers for Disease Control and Prevention's (CDC) handling of the events.
Kicking off the hearing, subcommittee Chairman Rep. Tim Murphy (R-PA) chastised the agencies, saying, "These failures just defy common sense, this is a culture of complacency."
"If NIH or FDA had done just a little more than what their policies required, or thought outside the box just a little bit, those agencies could have discovered the smallpox vials years earlier," he said.
In March, GAO released its report rating federal agencies that operate high-containment laboratories, or labs that handle highly hazardous biological agents classified at biosafety levels (BSL) 3 and 4, based on six criteria: incident reporting, roles and responsibilities, training, inventory control, inspections and adherence to the CDC and NIH's guidance, Biosafety in Microbiological and Biomedical Laboratories (BMBL).
Introducing the report, GAO Director John Neumann, said: "Most of the departments and agencies were using inspections or audits as a primary way of overseeing their high-containment labs, but they were often not routinely reporting inspection results to senior officials."
According to the report, FDA currently meets five of the six critical elements, and was only deficient in its policies for incident reporting, whereas NIH was the only agency that fulfilled all six criteria. CDC, on the other hand, was found to lack sufficient policies for incident reporting, and only partially met GAO's criteria for biosafety training and inspection policies.
In response, Dr. Segaran Pillai, director of the office of laboratory science and safety at FDA, said, "Although FDA's current policies do not provide for laboratory incidents to be reported to senior agency officials, incident reporting does occur within each of the FDA Centers and Offices."
Additionally, Pillai said he is "working closely with the FDA safety offices to develop a more comprehensive reporting mechanism to capture laboratory accidents, incidents, near misses and laboratory acquired infections. This new reporting mechanism will be implemented in the coming months and will require all Centers and Offices to report all such events to my office."
During the hearing, Rep. Richard Hudson (R-NC) asked Pillai about FDA's efforts to improve inventory control, referencing the 2014 smallpox incident.
Pillai responded that after the discovery, FDA conducted a full visual audit of all its storage areas and laboratories. "The vast majority of the FDA's 670,000 vials of samples were properly stored. However, there were two instances where select agents were improperly stored in secure locations," he said. Those vials, Pillai said, were reported to CDC and properly disposed of.
To prevent future incidents, Pillai said that FDA has instituted a new policy requiring a "single individual to be responsible for any cold storage areas being shared by multiple scientists." This, he said, should make conducting inventory control much simpler.
Additionally, Pillai said FDA has instituted a new, agency-wide electronic inventory control policy to track all hazardous biological agents and toxins.
Tags: BSL, Smallpox, Anthrax, GAO