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Preventing Bioterrorism

White House seeks to balance security and the scientific enterprise

by Glenn Hess
October 11, 2010 | A version of this story appeared in Volume 88, Issue 41

Credit: Paul J. Richards/AFP/Newscom
Coast Guard hazardous material workers huddle before they go to work inside the sealed Hart Senate Office Building, in Washington, D.C., to search for anthrax spores in November 2001.
Credit: Paul J. Richards/AFP/Newscom
Coast Guard hazardous material workers huddle before they go to work inside the sealed Hart Senate Office Building, in Washington, D.C., to search for anthrax spores in November 2001.

Legislation aimed at increasing the nation’s defenses against the threat of biological weapons is unlikely to become law this year. But helping to fill the void is an executive order issued by President Barack Obama this summer. It directs government departments to tighten security at research labs that possess the world’s most dangerous pathogens and toxins, including anthrax and smallpox.

Rep. Bennie G. Thompson (D-Miss.), chairman of the House Homeland Security Committee, says the White House order on optimizing the security of materials that could be used as agents of biological warfare mirrors provisions in the Weapons of Mass Destruction (WMD) Prevention & Preparedness Act (H.R. 5498), which his committee unanimously approved in June.

“With the issuance of this order, the President took a major step forward in addressing one of our most significant homeland security challenges—the threat of a biological attack,” Thompson says in a statement. Similar to the House bill, he notes, the executive order requires the federal government to develop security enhancements “to help prevent biological agents and toxins from getting in the hands of terrorists.”

The possibility that a terrorist organization might unleash a WMD remains one of the “gravest threats” to the security of the U.S. and its allies, the Department of State warned recently in its annual report on worldwide terrorism.

Even the use of a poorly designed weapon that results in only a limited health impact could cause significant disruption, the report says. It notes that a small-scale bioterrorism attack, such as the 2001 anthrax mailings, which killed five people and infected 17 others, can have a substantial economic impact. Costs include decontamination, medical treatment for those exposed, decreased commercial activity, social distress, and lost productivity.

“The terrorists can often meet their objective of creating disruption and fear without causing large numbers of casualties,” the State Department assessment says.

Over the past nine years, the number of biodefense research facilities in the U.S. has tripled. This rapid proliferation has produced concerns about the growing number of laboratory personnel with access to potentially lethal disease materials, accompanied by calls in some quarters for increased government regulation.

Currently, about 400 research facilities and nearly 15,300 individuals in the U.S. are authorized to handle materials on the government’s list of “select agents”—highly infectious pathogens and biological toxins declared to pose a severe threat to human or animal health by the Departments of Health & Human Services (HHS) and Agriculture. Biological research is regulated under a bio­terrorism law Congress passed in 2002.

Concern about security at U.S. bio­defense labs was heightened two years ago when the FBI concluded that Bruce E. Ivins, a microbiologist at a government research facility in Maryland, was likely responsible for the 2001 anthrax attacks on Senate staffers and postal workers. Ivins committed suicide on July 29, 2008, just as prosecutors prepared to charge him with murder for carrying out the attacks.

In response, the Senate Homeland Security & Governmental Affairs Committee approved legislation (S. 1649) in November 2009 that would require the Department of Homeland Security (DHS) to strengthen both physical security and personnel reliability programs at all “high containment” laboratories.

The bill, sponsored by committee Chairman Joseph I. Lieberman (I-Conn.) and ranking member Susan M. Collins (R-Maine), would divide the list of select agents into three tiers, subjecting facilities that handle the most dangerous pathogens and toxins to the highest level of security.

DHS would have oversight responsibility at highest risk, or “Tier 1,” laboratories, while HHS would be in charge of regulating sites in the remaining two tiers. The bill also calls for the creation of a national strategy for dispensing medical countermeasures to the public before and after a biological attack.

The measure is based largely on recommendations made in December 2008 by the congressionally mandated Commission on the Prevention of WMD Proliferation & Terrorism.

That blue-ribbon panel, chaired by former senators Bob Graham (D-Fla.) and James M. Talent (R-Mo.), concluded that an attack involving a WMD is likely to occur somewhere in the world by 2013 unless significant security improvements are made. The commission also said it is “more likely” that terrorists would be able to acquire and use biological agents than nuclear weapons.

The legislation was side-tracked, though, after the American Association for the Advancement of Science (AAAS) and several other scientific societies expressed concerns to the committee that the proposed new system of regulatory oversight and security procedures would be cumbersome and costly for laboratories, potentially hampering vital biodefense research.

Sen. Carl Levin (D-Mich.), the powerful chairman of the Senate Armed Services Committee, also pointed out that key provisions of the bill were in conflict with proposals made by the WMD commission. The panel opposed putting DHS in charge of security at Tier 1 research facilities and recommended that HHS and USDA maintain their existing responsibilities and lead the overhaul of lab security.

Members of the WMD commission “did indeed urge action, but they urged us not to act in the way this bill provides,” said Levin, who cast the lone dissenting vote when the homeland security committee approved the bill, 8–1, on Nov. 4, 2009.

The House legislation attempts to address some of the skepticism directed at the Senate version of the WMD bill. Approved 26–0 by the House Homeland Security Committee on June 23, H.R. 5498 splits the select agents list into only two tiers and leaves HHS and USDA in charge of the program.

“That was a positive move, taking the advice of the communities that had responded not too favorably to the Senate bill,” says Kavita M. Berger, associate program director at AAAS’s Center for Science, Technology & Security Policy.

However, in accord with the Senate bill, the House proposal gives DHS the lead role in developing enhanced security regulations for labs that possess the riskiest agents.

“The House bill thus occupies a middle ground between the current state of affairs, in which DHS has little responsibility for security of biological laboratories, and the Senate bill, which gives DHS the primary security role,” according to an analysis of the legislation by Stewart A. Baker and colleagues in the Washington, D.C., office of Steptoe & Johnson, an international law firm.

The executive order, which the Administration released on July 2, resembles the House legislation in that it gives HHS, working with USDA, lead authority over inspections of select agent labs.

The order directs HHS Secretary Kathleen Sebelius and Agriculture Secretary Thomas J. Vilsack to determine over the next 18 months which select agents present “the greatest risk of deliberate misuse with most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence.”

Labs that work with the riskiest materials will be subject to the tightest standards, including greater physical security and more rigorous screening of researchers. The remaining select agents could face less stringent security requirements.

The order also instructs the two lead agencies to consider reducing the overall number of pathogens and toxins on the select agent list and to coordinate inspections and oversight of the laboratories.

In addition to strengthening U.S. bio­security, the presidential order will reduce the hurdles that legitimate scientists face as they pursue research on potentially dangerous microbes, says Peter Emanuel, who helped draft the order as assistant director of chemical and biological countermeasures at the White House Office of Science & Technology Policy.

“It recognizes that access to these materials and the rules for handling them need to be carefully regulated. But it also recognizes that the best way to prepare for an attack involving one of these agents—whether that attack is by an enemy or by Mother Nature—is to know as much as possible about these microbes and toxins in advance,” Emanuel says.

AAAS’s Berger tells C&EN that the White House order “addresses a lot of the scientific community’s challenges” in dealing with security requirements. The new policy, she notes, “includes a way to deconflict requirements among different agencies that fund select agent work,” which should help reduce compliance burdens on research institutions.

Given the jurisdictional turf battles that often slow national-security-related legislation, Baker says, the House and Senate bills were introduced, at least in part, to send a signal to the Administration that it needs to act to better secure biolabs. “In this sense,” he says, “the legislation already may have achieved an important goal.”

Capitol Hill sources acknowledge that the current Congress is unlikely to pass the biosecurity legislation before adjourning after a brief postelection session in November. “It’s a tight window, and we have to negotiate with six committees for the bill to be brought to the floor,” says a member of the Democratic staff of the House Homeland Security Committee.

More than 80 congressional committees and subcommittees have power over DHS, the vast and sprawling enterprise Congress created in the wake of the Sept. 11, 2001, terrorist attacks. Such fragmented oversight has been sharply criticized by the WMD commission, which has urged Congress to consolidate committee jurisdiction.

Baker, who was the chief policy official at DHS from 2005 to 2009, says lawmakers might revisit biolab security next year. “The homeland security committees may be a little skeptical about whether HHS and Agriculture will do a good job of writing rules in this area,” he notes. “That said, the committees may decide to give the current process a little time to work before they decide to pursue legislation again.”


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