Senators, health experts demand action to address biolab accidents

Key members of Congress, public health leaders and biosecurity experts demand better oversight and accountability for laboratories in the wake of a USA TODAY Network investigation that revealed widespread safety lapses and pervasive secrecy that obscures failings by researchers and regulators.

The investigation uncovered hundreds of lab accidents and near-miss incidents that occurred in biological laboratories working with dangerous pathogens in recent years, putting scientists and sometimes even the public at risk. Oversight of labs is fragmented and largely self-policed, and even when labs commit the most egregious safety violations, they are allowed to keep operating and their names are kept secret by federal officials, the investigation showed.

The "lack of transparency and significant variability in how safety lapses are reported and reprimanded across all levels of government is very concerning," said U.S. Sen. Ron Johnson, chairman of the Senate Committee on Homeland Security and Governmental Affairs.

Johnson, R-Wis., said research on high-risk pathogens is important to protecting public health, but "we need to ensure agencies are holding labs accountable and shoring up trust in this program through reasonable transparency and communication with the public."

U.S. Sen. Tom Carper of Delaware, the ranking Democrat on the committee, said high-profile laboratory mishaps in recent months "underscore the need for our federal government to improve the way it handles select agents and infectious diseases at high-containment research facilities."

Much of the oversight of labs working with "select agents" — the government's term for viruses, bacteria and toxins that have the potential to be used as bioweapons — is hidden from public view, making it difficult to determine the effectiveness of the inspection and enforcement program. Labs that work with other dangerous microbes that aren't on the government's select agent list — such as tuberculosis bacteria and the MERS virus — are largely self-policed when it comes to biosafety.

More than 100 labs working with select agent pathogens have faced enforcement actions since 2003, the USA TODAY investigation revealed last month. 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. Regulators with the Federal Select Agent Program refuse to release the labs' names, citing a 2002 bioterrorism law they say requires such secrecy.

Former senator Joe Lieberman, a Connecticut independent who chaired the Senate's homeland security committee before he left Congress in 2013, said he hopes USA TODAY's reporting "spurs interest in the Administration and among lawmakers to reform a system that is clearly flawed." He called for "overhauling" the Federal Select Agent Program.

Lieberman co-chairs a Blue Ribbon Study Panel on Biodefense examining U.S. readiness for bioterrorism and emerging disease. The panel, sponsored by the Hudson Institute think-tank and funded in part by biotech companies, includes former Homeland Security secretary Tom Ridge and former Health and Human Services secretary Donna Shalala.

Regulation by the Federal Select Agent Program "does not fully address underlying issues in pathogen security, including human error and an inadequate culture of transparency and security awareness," Lieberman said. Some aspects of the program are "so burdensome and drawn out" that they discourage scientists from doing biomedical and biodefense research.

Lab regulators at the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, which jointly run the Federal Select Agent Program, did not respond to requests for comment on criticisms of the program.

Since last summer, lab safety has drawn concern from the public and policymakers in the wake of several high-profile accidents at federal laboratories. Last year, labs at the CDC had serious mishaps with anthrax, Ebola virus and a deadly strain of avian influenza, and forgotten vials of deadly smallpox virus were discovered in an unauthorized storage room at the National Institutes of Health. In recent weeks, the Pentagon has scrambled to locate dozens of live anthrax specimens an Army lab in Utah mistakenly shipped to labs across the country and abroad for 10 years that were believed to have been killed with irradiation but weren't fully inactivated.

These incidents are just a few of the hundreds that have occurred in recent years at labs operated by universities, private defense contractors and government agencies, the USA TODAY investigation revealed.

"The number of lapses in biosafety that were uncovered is alarming," said Amesh Adalja, a senior associate at the UPMC Center for Health Security, a think-tank that studies policy issues relating to biosecurity, epidemics and disasters.

Gregory Koblentz, deputy director of the biodefense graduate program at George Mason University in Virginia, expressed similar concern. "The overall scope of what you uncovered was surprising," he said. "Another really compelling point your series highlighted is how fragmented our oversight system is on biosafety. … We really need to have a nationwide, centralized biosafety oversight system."

Richard Ebright, a biosafety expert at Rutgers University in New Jersey who has testified before Congress, said lab oversight by the CDC and USDA is clearly ineffective. Ebright said both agencies have conflicts of interests as regulators because they conduct research in their own labs and their departments fund studies at facilities receiving inspections.

Koblentz and Adalja noted that in 2009 — in the wake of another string of lab incidents — a task force of several federal agencies made numerous recommendations for improving biosafety. Adalja said, "The degree to which the task force's recommendations have or have not been implemented — and if not, why not — merits investigation in its own right."

The recommendations of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight included identifying or establishing a federal agency to coordinate biosafety for all BSL-3 and BSL-4 labs and mandating compliance with key biosafety measures, which are considered to be guidelines. It called for creating a voluntary and non-punitive lab incident reporting system to analyze trends.

Six years later, it appears such recommendations have not been implemented. The task force was co-chaired by the U.S. Department of Health and Human Services and the USDA. It's unclear what happened after the recommendations were made or who was responsible for acting on them.

HHS officials did not answer USA TODAY's questions, instead issuing a general statement that the department "is strongly committed" to ensuring lab safety and security and that since the 2009 report, "we have and continue to implement concrete measures to improve the handling of hazardous microbiological agents and toxins in our labs." HHS provided no examples of actions taken to identify a single federal agency to oversee biosafety, mandate compliance with biosafety guidelines or create a better incident reporting system.

Former HHS secretary Kathleen Sebelius, who held the position at the time the task force issued its recommendations, was traveling and unavailable for an interview. USDA officials involved with the task force were traveling and unavailable for comment, a spokesperson said.

Officials with the White House Office of Science and Technology Policy did not respond to requests for comment about the 2009 recommendations, but they noted other recent actions taken to improve safety and assess the select agent regulations.

Creating a better lab incident reporting system — and process for disseminating lessons learned — is critical to reducing lab accidents, several experts said.

"People need to learn from those mistakes, but it's awfully hard to learn about mistakes that are made and what can be learned from them if you never hear about them," said Eric Blank, senior director of public health systems at the Association of Public Health Laboratories.

Blank said the United States needs to create a more comprehensive biosafety program for laboratories and not focus only on select agents with an emphasis on security. He said Canada's system of lab oversight could serve as a model.

The lack of transparency about lab incidents, federal oversight and enforcement actions — and even the whereabouts of research facilities experimenting with risky pathogens are other issues that need addressing, some public health experts and community advocates said.

Of particular concern are high-containment labs that work with the most dangerous microbes, yet there is no publicly available list of the facilities and even health departments and the federal government don't know where they all are. USA TODAY's "Biolabs in Your Backyard" project identified more than 200 biosafety level 3 and 4 lab facilities nationwide and disclosed in an online interactive database information about their research and more than 20,000 pages of their safety records collected lab-by-lab.

USA TODAY's database of labs is a "good start," but it's not comprehensive and local public health officials need federal regulators to share information about the labs and the types of pathogens they work with, said Blank, whose association's members include health department laboratories that monitor and detect health threats in their communities and respond to outbreaks.

"It's a challenge, as you noted in the article, to get information from the various federal programs. They're not particularly forthcoming, and that's kind of puzzling," Blank said.

"Public health is supposed to be a full partner in homeland security issues," said Jeff Levi, executive director of the Trust for America's Health, a national non-profit group that watchdogs public health issues.

Health officials must know about labs and lab incidents in their communities to be prepared to respond quickly to assess for any threat to public health, identify those who may have been exposed and, if needed, assist in arranging quarantine or ensuring infection control, said Chris Aldridge, senior director for infectious diseases and informatics at the National Association of County and City Health Officials.

The mistakes with shipments of live anthrax by the Army's Dugway Proving Ground are an example of how local public health labs and officials become the front-line responders when incidents happen, Aldridge and Blank noted.

Transparency about labs and incidents needs to extend to the public, said Scott Yundt, an attorney for Tri-Valley CAREs, a community-based watchdog group in Livermore, Calif., that has monitored activities at the Lawrence Livermore National Laboratory since 1983.

"Once these labs are operating, there really is no engagement with the public at all," Yundt said. He said there needs to be legislation to require regular disclosures of lab operations and incidents, similar to weekly public reporting required about safety issues at nuclear facilities done through the independent Defense Nuclear Facilities Safety Board.

Yundt said the public and policymakers should be able to readily find out, at least in general terms, the kinds of pathogens and research underway at each facility. Without that information, it's difficult to compare what labs are doing and determine whether efforts are duplicated and taxpayer money is used efficiently. He said labs' claims that releasing information poses a terrorism risk are overblown.

Koblentz at George Mason University said the issues around biosafety have more traction than they have in several years.

"I think there is a window of opportunity here to put in place some much more effective oversight mechanisms," he said. "We've been lucky that the incidents that happened last summer and that are ongoing with Dugway, as far as we know, haven't involved any infections. This is a wakeup call."

Read full coverage of USA TODAY's ongoing investigation of lab safety and security issues at biolabs.usatoday.com.

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