White House advisers call for greater accountability, safety at biolabs

In response to high profile incidents at labs working with dangerous bioterror pathogens, White House science and security advisers on Thursday issued a series of recommendations to improve safety and set deadlines to ensure they happen.

The memo and its attachments, which are 187 pages long, were issued by Lisa Monaco, assistant to the president for homeland security and counterterrorism, and John Holdren, assistant to the president for science and technology.

"The recommendations highlight several key principles for the national biosafety and biosecurity system, including: Transparency, swift incident reporting and accountability to the public, and material stewardship that includes strong inventory management and control measures," Monaco and Holdren said in a blog posting Thursday afternoon.

The recommendations focus on labs registered to work with about 65 dangerous "select agent" pathogens that the government considers to pose potential bioterrorism threats. They call for, among other things, increased training to create and strengthen cultures of biosafety and security; requiring that a qualified entity validate laboratory protocols used to kill infectious materials and providing information about incidents to the public "to the maximum extent feasible."

Thursday's memo also calls for determining "the appropriate number of high containment U.S. laboratories" that are needed to do research on select agent pathogens. The Government Accountability Office, the investigative arm of Congress, has for years raised concerns in its reports that the proliferation of labs working with the most dangerous pathogens has increased safety risks to workers and potentially the public.

After a series of serious incidents with specimens of anthrax, smallpox virus and a deadly strain of bird flu at federal labs during 2014, the White House Office of Science and Technology Policy sought public comment earlier this year on the impact of the current approach to regulation of select agent pathogens, including the program’s benefits, costs and limitations.

An ongoing USA TODAY Media Network investigation has since uncovered numerous serious incidents that have occurred in biological laboratories in recent years and revealed that pervasive secrecy obscures failures by labs and regulators to ensure research facilities don’t unduly put workers and the public at risk. Citing USA TODAY's reporting in its recommendation for greater transparency, an attachment to the White House memo notes that "perceived opaqueness" surrounding incidents at labs doing biodefense research has the potential of eroding public confidence.

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Information about select agent research and incidents should "be shared with the public, to the maximum extent possible," said the October report from the federal Fast Track Action Committee on the Select Agent Regulations, which is incorporated into the White House memo. While information about certain work characterizing biological threats can't be released fully for security reasons, the committee said: "In most cases, withholding this information has negligible security value, since the research, researchers, institutions, and agents involved with (select agent) research are often published in scientific journals or can readily be inferred from public materials."

The Federal Select Agent Program, which is jointly run by the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, oversees about 300 laboratories that are registered to work with any of about 65 types of bacteria, viruses and toxins on the government’s select agent list. Regulated pathogens include those that cause anthrax, botulism, plague and Ebola.

The USA TODAY investigation has raised questions about whether lax federal oversight and enforcement played a role in allowing an Army biodefense lab at the Dugway Proving Ground in Utah to mistakenly ship live anthrax for more than a decade. Despite CDC inspectors referring Dugway for enforcement action in 2007 for failures to deactivate live anthrax and ignoring tests that showed the kill process wasn’t fully effective, no fines were ever levied and inspectors never discovered the ongoing issue with a different anthrax kill method. The problem was instead identified in May by a Maryland biotech company that tested a sample of the supposedly killed anthrax it had received from Dugway and discovered it could still grow.

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The recommendations in the new White House memo are "positive steps," said Richard Ebright, a biosafety expert at Rutgers University in New Jersey who has testified before Congress on lab safety issues. He said the major changes involve creating an entity to validate that the protocols labs are using to kill pathogens, the addition of periodic public reporting on select agent incidents and the effort to determine how many high-containment labs are really needed to do research on select agent pathogens. Most of the other changes are minor, "positive but not especially meaningful," he said.

"It is disappointing," Ebright said, "that the document does not call for the change that many consider most important: namely, re-assignment of responsibility for select-agent oversight from the CDC and the USDA to an independent federal entity that does not perform and does not fund select agent work."

Amesh Adalja, a senior associate at the UPMC Center for Health Security, a think-tank that studies policy issues relating to biosecurity, said the most important aspect of the White House memo is that the recommendations have deadlines associated with them. "They're all valid and good recommendations. But recommendations only go so far if they are not implemented." Many of the deadlines are in early 2016.

Scott Becker, executive director of the Association of Public Health Laboratories, praised the recommendations and said they incorporated all of the fixes his group of regulated health department labs had pushed for. "The devil is in the details and we've got to keep holding them accountable in ensuring it actually gets done," he said. "I can also say your (USA TODAY) reports have really focused the issue," Becker said, noting that  "no one has paid attention until we had incidents."

On Thursday, the CDC separately released results of its own internal review of how it regulates safety and security labs that work with select agent pathogens. CDC director Tom Frieden ordered the review in July as USA TODAY was about to report on documents showing that CDC’s select agent inspectors have allowed labs nationwide to keep experimenting despite failing to meet key requirements on inspection after inspection – sometimes for years.

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The CDC review has resulted in several recommendations for improving the federal inspection process, including a greater emphasis on lab activities that pose the greatest risks.

"What we've done is review the program to ensure the work done with these agents is done as safely and securely as possible," said Stephen Redd, director of CDC's Office of Public Health Preparedness and Response. Redd directed the internal CDC review, which recommends working with regulated labs to do risk assessments of their work, finding ways to characterize the relative severity of inspection findings and prioritizing enforcement actions to focus on the highest risk violations.

The CDC workgroup also called for increased public release of information about inspection processes and findings at select agent laboratories. The current recommendation is only for the release of "aggregate information" on inspection findings — but not information about named, individual labs. But Redd said that as the content of select agent inspection reports evolves in response to the other recommendations, it's possible more information might be disclosed to the public. "This is not final, it's where we're starting," he said.

The timetable in the White House memo calls for the Federal Select Agent Program to begin an annual public release of aggregate information on laboratory incidents by June 2016.

The USDA has said it has been doing its own self-review of how it oversees select agent labs, and that review is still underway, the agency said Thursday.

Separately, a report released Wednesday by several high-profile biodefense experts said a “major reassessment” of the Federal Select Agent Program and its approach to oversight “is long overdue.” It called on Congress to ensure that a systematic and independent review is done by the National Science Advisory Board for Biosecurity, a federal advisory committee of outside experts. The report was issued by the Blue Ribbon Study Panel on Biodefense, which is co-chaired by former Homeland Security secretary Tom Ridge and former U.S. senator Joe Lieberman, who chaired the Senate’s homeland security committee before he left Congress in 2013.

While the select agent program has been “an impediment to would-be attackers,” the report said the program’s oversight “does not fully address underlying issues in pathogen safety and security, including how to prevent and deal with human error, how to ensure standards for safety and security awareness are met, and how to be more transparent within statutory confines about lapses and problems within the system.” The report also raised concerns about select agent regulations being overly burdensome and an impediment to research.

The panel, sponsored by the Hudson Institute and partially funded by biotech companies, also included former Health and Human Services secretary Donna Shalala and former U.S. senator Tom Daschle, whose office received one of the anthrax-laced letters in the 2001 attacks.

The Government Accountability Office for years has recommended improvements in federal oversight of labs, including the need to establish a single federal entity to oversee high-containment laboratories. These laboratories operate at biosafety levels 3 and 4, the two highest safety levels. Many of the pathogens that need the special safety controls used in these labs are on the government's select agent list, but not all of them.

Read USA TODAY's ongoing investigation of safety issues at laboratories nationwide, and look up information about labs near you: biolabs.usatoday.com

Follow USA TODAY investigative reporter Alison Young on Twitter: @alisonannyoung