Balancing Lab Security

Congress is considering wide-ranging legislation to address the threat of a biological attack on the U.S. homeland. But scientists are cautioning about the risks of overregulating laboratories where scientists work with the world’s deadliest pathogens, saying strict new security measures, in addition to those already implemented since the anthrax attacks of 2001, could have a chilling effect on vital infectious disease research.

“The laboratory infrastructure in the U.S. has made tremendous progress in the past decade to meet the challenges of emerging diseases and biothreats,” Ronald M. Atlas, cochair of the American Society for Microbiology’s Committee on Biodefense, said in testimony last month before the House of Representatives’ Energy & Commerce Subcommittee on Oversight & Investigations.

“It took a number of years and substantial effort to arrive at the careful equilibrium that currently exists to oversee and manage research activities,” Atlas noted. “We believe that precipitous, excessive policy changes could upset this delicate balance.”

Scientists are concerned about a bill sponsored by Sen. Joseph I. Lieberman (I-Conn.), chair of the Senate Homeland Security & Governmental Affairs Committee, and Sen. Susan M. Collins of Maine, the committee’s ranking Republican. The bill would tighten security at labs that handle the most dangerous pathogens and would require other steps to prevent or respond to a terrorist attack.

On Sept. 8, the lawmakers introduced the Weapons of Mass Destruction Prevention & Preparedness Act (S. 1649) in response to the conclusions of a congressionally mandated commission that a weapons of mass destruction (WMD) attack is “more likely than not” to occur within the next four years and that a biological strike is more likely than a nuclear or chemical attack.

“Terrorists want to do us great harm, and they know that a biological weapon could devastate American society,” Lieberman remarked at a Sept. 22 hearing by the Senate homeland security panel. “Our legislation would prevent and prepare for WMD attacks and bioterrorism in particular.

“Most importantly,” he added, “our legislation would heighten security at labs working on the world’s most dangerous pathogens and improve our government’s ability to distribute vaccines and antibiotics quickly. We seek to raise our level of preparedness and minimize the consequences of an attack—thus deterring terrorists from attacking in the first place.”

Collins observed that although the mental images of mushroom clouds and nuclear blasts are powerful and frightening, the more likely terrorist threat is from a biological weapon. “In contrast to nuclear weapons, the technological hurdles are lower to develop and disseminate a bioweapon,” she explained at the Senate hearing.

Collins also pointed out that the threat of a biological attack begins at home. “Some of the world’s most dangerous pathogens are not secure, and that includes pathogens housed in biolabs right here in the U.S.,” she said. “The fact is that thousands of people in the U.S. have access to dangerous pathogens. More than 400 research facilities and nearly 15,000 individuals are on the ‘select agents list’—an authorization to handle the most deadly pathogens.”

The legislation was prompted by the December 2008 recommendations of the nine-member Commission on the Prevention of Weapons of Mass Destruction Proliferation & Terrorism, which was established to examine national security policy in the wake of the Sept. 11, 2001, terrorist attacks on the U.S. (C&EN, Dec. 8, 2008, page 6).

The bill would transfer authority over work conducted on human pathogens from the Department of Health & Human Service (HHS) to the Department of Homeland Security. It would direct DHS to set new security standards for facilities that work with 82 biological agents and toxins that have the potential to pose a severe threat to public health.

“We have developed a tiered approach for security levels based on the amount and the degree of risk posed by the pathogens being researched at a particular facility,” Collins explained at the hearing. “The greater the risk, the more stringent the security requirements.”

The most lethal pathogens that terrorists are likely to use in an attack, such as smallpox and anthrax, would be classified as Tier 1 agents. DHS would be authorized to distribute $50 million in grants each year through 2013 to help private laboratories that handle these agents offset the cost of the upgrades.

Collins compared the security measures for high-containment biological labs to the requirements of the Chemical Facility Anti-Terrorism Standards, the federal plan for regulating security at the nation’s high-risk chemical plants.

“This is the kind of approach that we used successfully in our chemical facility law, where we had a tiered approach with greater mandates for security to apply to the highest risk facilities,” she said.

A negotiated rule-making, with federal agencies and research institutions at the table, would develop the enhanced security standards. “This would ensure that regulations, which make our nation’s labs more secure, would not have the unintended consequence of deterring legitimate research endeavors,” Collins said.

To prepare for the aftermath of a successful attack, the legislation also requires the development of a national strategy for using the U.S. Postal Service to rapidly deliver vaccines, antibiotics, and other life-saving drugs to the public. And it calls for the creation of a National Bioforensics Analysis Center to quickly identify the perpetrator of a WMD attack.

“We are now spending billions of dollars to stockpile these antibiotics and other medicines, but we still lack a plan for distributing them quickly and efficiently after an attack or an outbreak of disease,” Lieberman said.

Former Sen. Bob Graham (D-Fla.), who chaired the WMD commission that predicted a future biological attack, has endorsed the Lieberman-Collins legislation. “This is a critical step,” he told the Senate committee at the hearing. “There are about 20 countries in the world who are major producers of pathogens and another 20 or more are rising in their capability. We need to control this issue now. Time is not on our side.”

Gregory D. Kutz, managing director of forensic audits and special investigations for the Government Accountability Office (GAO), testified that HHS’s Centers for Disease Control & Prevention (CDC) has taken “limited action” to improve perimeter security around the nation’s five Biosafety Level 4 labs—those that handle infectious materials requiring the highest level of containment, such as the Ebola and smallpox viruses.

“While three labs had all or nearly all of the key security controls we assessed, two labs demonstrated a significant lack of these controls,” Kutz said. Since GAO made that initial assessment, those two labs have taken steps to enhance security, but many deficiencies remain unaddressed, he added.

Although armed guards, intrusion detection systems, and other perimeter security measures might stop a terrorist from entering a lab from the outside, Graham said, the more likely scenario “is the one that has already occurred, which is a rogue scientist.”

Graham pointed to the Federal Bureau of Investigation’s conclusion last year that Bruce E. Ivins, a microbiologist at the Army’s biodefense lab at Fort Detrick, Md., was the primary suspect in the mailing of a set of envelopes containing anthrax spores to news outlets and two Senate offices in late 2001, killing five people and sickening 17 others. Ivins committed suicide on July 29, 2008, as federal attorneys prepared to press charges against him (C&EN, Aug. 11, 2008, page 13).

Meanwhile, scientists are warning that security requirements should not become so intrusive or rigid that they hamper vital disease research and discourage researchers from working in the field.

There are legitimate concerns that a biological agent or toxin could be used in a criminal or terrorist act, but policies and procedures implemented by the federal government since the 2001 attacks have improved lab security, a panel of 14 university and private-sector scientists said last month in a report issued by the National Research Council, an arm of the National Academies.

Instances of individuals gaining “inappropriate” access to biological agents have been “very, very rare,” committee Chair Rita R. Colwell, a professor at both the University of Maryland and Johns Hopkins University, remarked at a Sept. 30 press conference.

In the 161-page report, the panel concludes that “there is no ‘silver bullet,’ that is, no single assessment tool that can offer the prospect of effectively screening out every potential terrorist.” The report cautions that “overzealous” security enhancements could slow the development of countermeasures against biological pathogens.

The most effective way to prevent the deliberate misuse of deadly germs, the report advises, is to instill a culture of trust and responsibility among scientists. Efforts to ensure reliable personnel should come from within the laboratories through increased engagement and monitoring by managers and staff. “The goal should be that individuals watch out for each other and take responsibility for their own performance and that of others,” the report states.

The American Association for the Advancement of Science issued a similar warning in a report earlier this year, saying that additional lab security measures could undercut biological research. A review of existing biosafety training programs, conducted by two units of AAAS, found that the programs “may already address concerns” that have arisen about the reliability of personnel at high-containment facilities.

The report recommends that before instituting any new requirements, the government should “consider existing employment and biosafety training practices ... as they may already contribute to vetting of personnel” and the prevention of “malicious actors or unstable personnel” from gaining access to hazardous pathogens.

More than two dozen experts in biosafety, biosecurity, and life sciences, as well as architects and engineers, participated in the study, which is based in large part on a workshop they attended at AAAS this past March.

Kavita M. Berger, project director at the AAAS Center for Science, Technology & Security Policy and coleader of the biosafety study, says her group has consulted with congressional staff about the Lieberman-Collins bill.

“Our interactions with the staff indicate that they are taking seriously some of the concerns that research institutions face, such as the financial and time burdens associated with implementing security procedures,” Berger tells C&EN. “We just need to see how this bill progresses over time.”