BiolabsLawmakers demand answers on labs’ handling of deadly pathogens

The leaders of the House Energy and Commerce Committee from both parties yesterday sent a letter to the Inspector General of the Department of Health and Human Services demanding answers regarding the Federal Select Agent Program (FSAP). The FSAP comprises the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Services/ Agriculture Select Agent Services. The FSAP oversees the possession, use, and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal, or plant health or to animal or plant products.

The committee leaders’ letter builds on the ongoing bipartisan investigation surrounding the shipments of live anthrax from a Department of Defense laboratory at Dugway Proving Ground in Utah.

Chairman Fred Upton (R-Michigan), Ranking Member Frank Pallone Jr. (D-New Jersey), Oversight and Investigations Subcommittee chairman Tim Murphy (R-Pennsylvania), and Subcommittee ranking member Diana DeGette (D-Colorado) wrote,

We are writing to obtain baseline information about enforcement of the federal select agent program (FSAP). On 28 May 2015, USA Today reported — based on information provided by the CDC — that since 2003, the CDC had referred seventy-nine labs for potential enforcement actions by the HHS Office of Inspector General (OIG), with fines levied against nineteen entitles totaling more than $2.5 million. The article also noted that five laboratories had multiple referrals for enforcement actions, two labs were kicked out of the program, five labs were suspended from doing any select agent research, and seven labs were currently under a performance improvement plan. The committee seeks to confirm this information and obtain more details from OIG.

USA Today notes that the newspaper’s 28 May report revealed that more than 100 labs have faced enforcement actions since 2003 because of significant safety violations while working with select agent pathogens such as anthrax. Lab oversight is cloaked in secrecy, however, making it difficult to determine the effectiveness of the federal inspection and enforcement program.

The investigation found that even when labs commit the most egregious safety violations, they often are allowed to keep operating and their names are kept secret by regulators.

The committee members directed ten questions to the HHS IG in an effort to learn details about labs that have been fined or faced other enforcement actions, including suspension or revocation of their federal authorizations to work with select agents — viruses, bacteria, and toxins that could be used by terrorists.

The HHS IG was given until 20 July to respond to the ten questions.

“Congress has a responsibility to the American people to ensure that labs doing research to keep us safe do not, out of carelessness, endanger us instead,” DeGette told USA Today.

Pallone said the committee needs more information to understand how safety lapses keep happening. “So far we’ve been lucky, but that luck may run out if we don’t get the system fixed,” he said. “We’re not talking about shipping frozen broccoli here. We’re talking about highly dangerous pathogens that could harm public health or even have broader security threats if they fall into the wrong hands.”

— Read more in Alison Young and Nick Penzenstadler, “Inside America’s secretive biolabs: Investigation reveals hundreds of accidents, safety violations and near misses put people at risk,” USA Today (28 May 2015)