WASHINGTON -- Federal officials and independent experts this week prodded Congress to consolidate government oversight of the nation's disease research laboratories but offered divergent views about which agency should take the lead role (see GSN, Sept. 22).
(Sep. 25) -
A U.S. scientist showers in disinfectant after working in a high-security infectious disease laboratory. Analysts urged lawmakers this week to establish an entity that would oversee the nation's most sensitive biological research sites (U.S. National Institute of Allergy and Infectious Diseases photo).
"There needs to be, clearly, somebody, in overall charge," Jean Reed, deputy assistant to the defense secretary for chemical and biological defense and chemical demilitarization, told the Senate Judiciary Terrorism and Homeland Security Subcommittee on Tuesday.
An influx in recent years of billions of dollars for biodefense activities led to rapid expansion of disease research facilities. With that came concerns about accidents and the potential misuse of lethal disease materials.
A number of incidents have provided fuel for those worries. The federal government last year levied a $1 million fine against Texas A&M University when it failed to notify authorities that researchers had been exposed to -- and in one case, infected by -- infectious agents. Meanwhile, the FBI last year identified the perpetrator of the 2001 anthrax mailings as a researcher from the Army biodefense site at Fort Detrick, Md. (see GSN, July 28).
Senators Joseph Lieberman (I-Conn.) and Susan Collins (R-Maine) this month introduced legislation that would require the U.S. Homeland Security Department to establish security standards for laboratories that handle the most dangerous disease materials (see GSN, Sept. 9).
On Tuesday, subcommittee Chairman Benjamin Cardin (D-Md.) decried the gaps in government oversight, saying about 15 federal departments work with biodefense laboratories but "no one agency has primary or full responsibility" for overseeing their safe operations. Those departments include Defense, Homeland Security, and Health and Human Services.
He said most people would turn to the Homeland Security Department as the "logical place" to have responsibility over facilities working with disease materials. The lawmaker did not elaborate.
When DHS compliance assurance program manager Brandt Pasco said the agency only had authority over the 42 sites it funds, Cardin replied, "That's clearly inadequate."
That same day Cardin said he would call for legislation to select a lead agency to oversee security measures at high-containment laboratories and establish uniform guidelines for those sites, including background checks of researchers, according to a statement from his office.
The Pentagon's framework for safeguarding select agents -- pathogens or biological toxins declared to pose a severe threat to human or animal health -- consists of prevention of accidents, active methods to avert biological terrorism or other disease breakouts, ensuring personnel are vetted, and accounting for all sensitive materials, according to Reed. The measures are derived from protocols originally designed to protect nuclear and chemical weapons materials, he said.
Therefore, "they might not constitute the basis for best practices and procedures for the nation as they could discourage participation by critical organizations and could be limiting to medical and other life sciences research programs," Reed told the panel.
For example, the use of "single-scope" background investigations precludes foreign nationals and people with money troubles from working with select agents, he said. The investigations are also "time intensive and expensive," according to Reed.
He said one way to strengthen laboratory security would be to have the National Security Council use its interagency policy committee process, with input from industry and academia, to review the recommendations from several upcoming reports on facility security and develop an approach that "optimizes the balance of science and security."
However, another witness sharply disagreed with that solution.
"I think having an interagency task force do this is a big mistake. I think putting it in the National Security Council is a big mistake," said Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland.
"No blame to the national security adviser, but he has a lot of things on his plate," he told the panel. "There must be somebody in the federal government that assumes overall responsibility."
Greenberger complimented Reed for noting that Defense Department measures likely could not apply to university facilities.
"It's impossible to apply military precision and security to a university laboratory" due to the lack of resources at many schools and the "element of openness" on most campuses, he said.
Instead, the Centers for Disease Control and Prevention should take the lead, according to Greenberger. "In all candor, you'd have to say the ... CDC has the superior record" in terms of supervising researchers at sites that receive federal funds, he said.
Greenberger said he did not know if the Atlanta-based health agency had enough resources to handle the job as it grapples with the H1N1 flu epidemic, but "they should be the single agency setting up standards -- both safety standards [and] security standards -- for all those laboratories, having the entire inventory, being responsible for having evidence of mishaps and setting up an accreditation process."
Nancy Kingsbury, the managing director of applied research and methods at the Government Accountability Office, said instead that oversight should be put "at the HHS level." The Health and Human Services Department is the parent agency to the Centers for Disease Control.
Meanwhile, the congressionally created Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recommended that Health and Human Services, in coordination with the Homeland Security Department, lead an "interagency effort to tighten government oversight of high-containment laboratories," said former Senator Bob Graham (D-Fla.), who chairs the panel.
Also testifying before the subcommittee, he said Health and Human Services should ultimately assume oversight of the facilities that handle the most sensitive disease agents.
In addition, the WMD panel recommended the national security adviser -- in consultation with the heads of the Health and Human Services, Agriculture, Defense and Homeland Security departments, and other executive agencies -- identify a single entity to conduct a "periodic strategic evaluation" of high-containment laboratories, Graham told the committee. He did not elaborate on how to circumscribe the focus for such a review.
Differences on Classification System
The witnesses Tuesday also split over whether the biological research community should adopt a tiered security system based on the level of danger posed by material.
Lieberman's bill establishes a tiered system for pathogens under research at U.S. facilities, which was recommended by the WMD commission.
Tier one would consist of "about eight agents," according to Graham. It would contain those pathogens that are "most readily weaponized," he said without citing specific diseases.
The second tier would include pathogens that potentially could be weaponized, while the third tier would be "everything else," the former lawmaker told the committee.
Reed said that a tiered system would "quite possibly be something one might choose to employ" but stopped short of endorsing the idea.
"I'm not sure we know enough about the mix of pathogens in different laboratories to have a view yet of whether" a tiered system would be effective, Kingsbury said.
The proposed legislation would also mandate general security measures at facilities that work with 82 disease-causing select agents and toxins designated by Health and Human Services and Agriculture departments. It would also require the HHS secretary to set standards for personnel reliability programs and laboratory risk assessments, according to the text of the bill.
The measure also imposes a civil penalty for violating those rules in an amount not exceeding $250,000 for an individual or $500,000 for a laboratory handling a tier one agent.