Growing number of biosafety labs raises public health concern

Introduction

Since the 2001 anthrax letter attacks that killed five people and raised the specter of bioterrorism in the United States, the number of high-level biosafety labs operated by governments, universities and others to study potentially lethal pathogens has been expanding rapidly. According to a 2013 report to Congress, the number of these labs grew by almost 10 percent, from 1,362 to 1,495, between 2008 and 2010 alone.

The construction of hundreds of new labs designed for working with dangerous organisms has occurred without any central oversight or clear strategy for expansion, congressional analysts and others say. The expansion has raised concerns that many of these labs may not be needed and that their sheer number raises the risk of exposure to the public from the germs they study.

The FBI’s chief suspect in the 2001 attack, who committed suicide in 2008 before he could be charged in the case, was a biologist at the Army’s biodefense lab at Fort Detrick, Maryland.

Despite the concerns, Los Alamos National Laboratory is pushing forward a 2001 plan to build labs to work with disease germs like anthrax and tuberculosis, even though Los Alamos has not adequately explained what the facility would be used for or why it is needed, according to a report released last week by Department of Energy Inspector General Gregory Friedman.

Friedman wrote that the $9.5 million proposal had been made without fully assessing the need for and cost effectiveness of the project, and that the DOE’s National Nuclear Security Administration, which runs Los Alamos and other energy labs, “needs to fully reassess its need for biological research facilities.”

Friedman’s criticism comes just a month after officials at the Food and Drug Administration in Bethesda found 12 boxes containing vials of smallpox, dengue fever and influenza viruses — among other potentially deadly disease agents — squirreled away in cold storage.

It also comes after Congress in January created an independent commission to consider consolidating or downsizing the Energy Department’s 17 research labs, which cost $10 billion annually, in part to reduce duplication of efforts. At their first meeting in July, Secretary of Energy Ernest Moniz said he hoped the panel would come up with a “strategic” view of the laboratories in the 21st century. Its findings aren’t expected until next year.

Today there are more than 450 research centers operating as many as 1,500 labs capable of conducting research on biological agents such as Ebola and anthrax, said Richard Ebright, a professor of chemical biology at Rutgers University and a laboratory director at the university’s Waksman Institute of Microbiology. Ebright said more than 12,000 individuals are authorized to work with these lethal pathogens.

The major concern, he said, is that the sheer number of biosafety labs could raise the risk that dangerous pathogens will accidentally or deliberately be released into the wild.

“It would be funny if it were not so unfortunate,” Ebright said. “The response to the problem magnified the problem, at enormous cost as well.”

Biosafety labs are broken into four categories, with BSL-1 for the lowest-risk pathogens and BSL-4 labs dealing with lethal agents like Ebola that have no vaccine or treatment. The Los Alamos expansion would include BSL-3 labs, which study agents like anthrax, Rift Valley fever, malaria and West Nile virus that can cause possibly lethal infections, as well as a BSL-2 facility, where scientists will study less dangerous agents.

Ebright said the DOE in particular has “no mission that is relevant in any way, shape or form, directly or indirectly, to biological weapons agents. It has no need, directly or indirectly” for a BSL-3 lab.

Ebright told a congressional hearing on biolab safety in July that the number of BSL-3 and BSL-4 labs should be cut by a factor of 20 to 40. He told the Center for Public Integrity the labs should be restricted to just 22 sites — all of which would have BSL-3 labs and eight of which would also have BSL-4 labs. Concentrating these organisms at fewer laboratories would make it easier to keep them secure, according to advocates for limiting their number.

Smallpox, which was eradicated in the wild, is supposed to be held in only two places on Earth: at a secure facility at the Centers for Disease Control and Prevention in Atlanta and a virology institute in Novosibirsk, Siberia.

Nancy Kingsbury, the managing director for applied research and methods at the Government Accountability Office, said federal biosafety labs have been constructed by multiple government agencies, each of which assessed their own needs without regard for what other agencies were doing.

“Each agency has its own mission, each agency has its own relatively narrow focus on their part of the problem, and so each agency has gone to Congress and gotten funding to do x, y and z,” Kingsbury told the Center. “There are not good cross-agency mechanisms for looking at these issues and deciding who should be in charge.”

To add to the confusion, Kingsbury said there are multiple committees within Congress that have oversight of the agencies that have laboratories or want them, meaning that both operation and oversight is fragmented. She called it “a tough nut to crack.”

BSL-3 and BSL-4 labs are operated by the CDC, the National Institutes of Health, the departments of Energy, Defense and Homeland Security, as well as a number of universities and private companies.

Concerns about the proliferation of these labs date back to shortly after the expansion began in the early 2000s. A September 2009 GAO report called for a national strategy for oversight of the labs, saying that it was impossible to say how many there were because only those working with select agents needed to register.

“As a consequence, no federal agency can determine whether high-containment laboratory capacity may now be less than, meet, or exceed the national need or is at a level that can be operated safely,” the 2009 report said.

In addition to the discovery of the vials of smallpox and other deadly agents in Bethesda last month, employees at the CDC’s Atlanta headquarters were accidentally exposed to anthrax in June. During the July hearing on these incidents, before a House Energy and Commerce subcommittee, Chairman Tim Murphy, R-Pa., said the incidents represented “a pattern of reoccurring issues, of complacency, and a lax culture of safety. This is not sound science, and this will not be tolerated. These practices put the health of the American public at risk. It is sloppy, and it is inexcusable.”

Marian Downing, president-elect of the American Biological Safety Association, who previously worked in BSL-2 and BSL-3 labs with Abbott Laboratories in Illinois, said there are institutions that have BSL-3 facilities that don’t need them.

But she said the majority of these labs follow the CDC’s guidelines, Biosafety in Microbiological and Biomedical Laboratories, as if they were strict standards.

“For people to say there are no standards, it makes the public think it’s out of control,” but, she said, that’s not the case. “There are these guidelines, they’re basically mandatory if you’re working on select agents or toxins.”

While most of the expansion of the nation’s biolabs occurred during the Bush administration, the Obama White House has defended the trend.

According to the 2013 GAO report, officials with the White House Office of Science and Technology Policy said they did not agree with the GAO’s recommendation that a single agency should conduct a government-wide strategic evaluation of high-level biolabs. Nor did the office agree that expanding the number of labs increased the risk to the public. A spokeswoman for the office did not respond to requests for comment.

Kingsbury told the Center that the labs are generally safe and run by experienced scientists, but that the sheer number of these facilities increases risk.

“You can’t say the risk is zero,” she said. “So if the risk in a given lab is not zero — and these recent episodes were largely human-error driven — if the risk is not zero, then the more labs you have, the bigger the risk there is.”

Los Alamos completed an environmental assessment in 2002 of plans to build two BSL-3 labs. The facility to house them was constructed a year later. The project was delayed for years, however, because of a lawsuit by two advocacy groups, Nuclear Watch New Mexico and Tri-Valley CAREs, located in Livermore, California.

In the environmental assessment, Los Alamos’ management said that research into disease organisms was not outside the scope of its mission, nor inconsistent with existing work at Los Alamos.

The assessment said that additional BSL-3 labs were required due to the increasing concern that biological agents could pose a national security threat. Similar labs elsewhere, it said, were often booked for other projects and using them added risks in handling the agents.

“In order to more effectively utilize and capitalize on existing onsite facilities and capabilities … NNSA needs BSL-3 laboratory capability within the boundaries of the national lab,” the assessment said.

In his July report, DOE Inspector General Friedman wrote that the Los Alamos project would nearly double the NNSA’s BSL-3 lab space. Yet the NNSA doesn’t track or coordinate its biological research facilities across its sites and laboratories, Friedman wrote.

Friedman also wrote that Los Alamos didn’t consider whether it would duplicate capacity at other places, including at Lawrence Livermore National Laboratory, which has three BSL-3 labs.

Most of the work would come from other federal agencies rather than the Department of Energy, the IG report said, while the demand for work from these agencies is less certain than Los Alamos claimed.

IG spokeswoman Felicia Jones said they spoke with two prospective clients named by Los Alamos, the Department of Defense and the Department of Homeland Security. According to the report, both agencies told the IG they had no specific plans for conducting research at a BSL-3 lab at Los Alamos. The report said officials at one of the agencies said it was planning to build its own BSL-3 facility in the next two years. It did not say which one.

When asked for comment about the Inspector General’s report, representatives from both Los Alamos and the NNSA referred the Center to the official management response included in the report. They did not respond to requests for further comment.

In the response, NNSA Administrator Frank Klotz wrote that his agency would develop metrics to measure the use of biosafety labs and would use that data to make decisions on facilities. Klotz wrote that the proposed work at Los Alamos could not be conducted at Lawrence Livermore laboratory, though he did not explain why.

Klotz also wrote that his agency would re-evaluate the analysis of the proposed BSL-3 facility at Los Alamos and “more formally document” the mission, need and potential customers.