Congress questions oversight of biolab safety at hearing

WASHINGTON -- Federal laboratories working with bioterror pathogens are "the leading offenders" that have repeatedly been referred for sanctions because of safety violations, yet regulators from the Department of Health and Human Services have largely responded with violation letters, according to documents released by Congressional watchdogs for a hearing on lab safety Tuesday.

"What we have here is a pattern of recurring issues, of complacency, and a lax culture of safety," said U.S. Rep. Tim Murphy, R-Pa., who chaired the hearing before the investigations subcommittee of the House Energy and Commerce Committee. "Last year, CDC Director (Tom) Frieden stated that this was a ‘wake-up' call. However, it appears that critical government agencies have hit the snooze button.

"What is going to change this time? And when?"

Among the labs receiving multiple referrals for enforcement actions is the U.S. Army's Dugway Proving Ground facility in Utah, which is at the center of an international scandal over its inadvertent shipment of live anthrax specimens for more than a decade. As of this week, those specimens had been traced to 192 labs in the United States and seven foreign countries.

Dugway's labs were previously referred for enforcement actions in 2007 for failures to inactivate anthrax specimens and ignoring tests that indicated a problem, USA TODAY reported in June. Documents released in advance of Tuesday's hearing revealed Dugway faced sanctions again in 2011 after it made three unauthorized shipments of potentially deadly Botulinum neurotoxin.

In both cases, regulators issued violation letters to Dugway instructing the facility it should examine its policies and practices, take corrective action and monitor its safeguards, according to Gregory Demske, chief counsel for the HHS Office of Inspector General (OIG), which enforces lab regulations for inspectors at the Centers for Disease Control and Prevention.

"As a federal entity, Dugway presents an enforcement challenge for OIG," Demske told the committee. On Monday, the OIG received a third referral for enforcement action about Dugway, he said, and it's under review.

An ongoing USA TODAY Media Network investigation has revealed widespread safety lapses at government, university and private labs nationwide -- and pervasive secrecy that obscures failings by researchers and federal regulators.

Earlier this month, Frieden ordered a comprehensive review of how it regulates safety at labs as USA TODAY prepared to report on documents showing the agency's inspectors have allowed research facilities to keep experimenting with bioterror pathogens despite failing to meet key requirements for years.

Dan Sosin, CDC's deputy director for public health preparedness and response, told the committee the agency realizes the Dugway incident "raises serious and challenging issues." He emphasized the importance of the research done by labs, but said safety must come first. Sosin said the CDC is reviewing how it oversees select agent labs and will work with anyone willing to help the agency improve. "Where improvements can be made to better the program, we will make them," Sosin said.

Murphy, however, scoffed at this, telling Sosin: "Please let the CDC know I don't believe them anymore." Murphy asked whether Sosin had seen a USA TODAY article published Monday night revealing the agency lacked a policy it had previously said existed to ensure lab incidents in its own labs were reported to a top agency official.

Congressional concerns about lab safety and regulatory oversight have grown in weeks after the discovery in May that the Army's Dugway lab had shipped live anthrax to defense contractors, academic researchers and government labs that thought they were receiving inactivated spores that could safely be used for research on detection equipment and diagnostic tests. Nobody has been sickened, though some researchers have been given antibiotics as a precaution.

Recent investigations by the CDC and the Pentagon blamed inadequate irradiation procedures and verification testing as among the reasons for Dugway's anthrax mistakes.

It is unclear why CDC lab inspectors over the years apparently didn't identify Dugway's ongoing failures in its use of radiation to kill anthrax specimens – despite referring the facility for enforcement action in 2007. The earlier case involved Dugway's use of an experimental chemical method for inactivating anthrax.

U.S. Rep. Diana DeGette of Colorado, the subcommittee's ranking Democrat, noted that that the Pentagon's investigation of the Dugway incident found there is not enough scientific literature to develop effective protocols to reliably inactivate anthrax spores. "Now, this is not my area of expertise, but that finding seems troubling on its face," DeGette said. "How have we conducted research on this dangerous pathogen for the past decade without thoroughly understanding how to inactivate it?"

Sosin said the CDC, among other things, is developing a research agenda on spore biology to help address the current gaps in the science.

Colonies of anthrax bacteria.

More than 100 labs working with select agent pathogens have faced enforcement actions since 2003, USA TODAY revealed in May. Five labs have had "multiple referrals" for sanctions, two labs have been kicked out of the program and five labs have been suspended from doing any work with these kinds of pathogens. But regulators with the Federal Select Agent Program refuse to release the labs' names, citing a 2002 bioterrorism law they say requires such secrecy.

Documents released by the committee's investigative staff in advance of Tuesday's hearing indicate that many of those labs with "multiple referrals" for sanctions are operated by federal agencies.

Citing USA TODAY findings, the bipartisan leaders of the committee earlier this month demanded the names of sanctioned labs and details about actions taken by regulators at the CDC and the inspector general's office.

"HHS OIG has not imposed civil monetary penalties on any federal government agency entity, even though federal government agency entities are the leading offenders with multiple violations," the committee's hearing memo said.

One unnamed federal lab was referred for enforcement actions three times. The inspector general's staff closed that lab's case by issuing an audit report to the lab, the memo said.

Since 2002, 68 cases involving 53 entities have been referred to the inspector general's office for possible enforcement actions. The inspector general's office found violations in 30 cases. In 10 cases it issued "notice of violation letters" and in 20 others it collected about $2.4 million in fines. There are currently six enforcement referrals pending with the office, Demske testified.

Yet 75% of total fines collected was imposed on just two labs, the committee's hearing memo said, with an average settlement amount for the others of about $54,000.

In testimony prepared for Tuesday's hearing, Demske said the "OIG carefully evaluates its enforcement options for each referral by analyzing the facts and circumstances of the alleged violations." The office has seen varying levels of risk in the violations referred for enforcement, he noted. It has violation notice letters, instead of fines, in some cases: five letters have gone to federal labs, three to universities and two to other private entities, according to his testimony.

While the OIG believes it has the authority to fine federal labs, Demske's said it hasn't done so because it would simply involve a transfer of money from one agency's budget to the General Fund of the Treasury, meanwhile the government would incur the cost of negotiating or disputing the fine. Since 2002, the OIG has received 16 referrals for enforcement actions involving federal entities and sent five notice of violation letters, he testified.

The Government Accountability Office, the investigative arm of Congress, has issued repeated reports since 2007 warning that the proliferation of high-containment labs that work with the most dangerous pathogens has increased the aggregate risk of an accidental or intentional release of viruses, bacteria or toxins. The GAO has recommended improvements in federal oversight over the years, including developing national standards for lab construction, operation and maintenance.

In written testimony for Tuesday's hearing, GAO staff said the Army's anthrax shipments and other lapses at the CDC's own labs "have illustrated multiple breakdowns in compliance with established policies and inadequate oversight of high-containment laboratories."