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Competing Responsibilities? Report Addresses the Security Risks of Biological Research
As the U.S. Congress considers wide-ranging legislation to tighten safeguards against biological threats, a new report from AAAS and partner organizations offers suggestions on how to minimize security risks while promoting education and cutting-edge research.
The report notes that scientists and security specialists share a common goal of preventing bioterrorism but continue to have differing perspectives on how best to assess risks, promote good research practices, and advance science.
It urges government regulators to do more to harmonize the policies of various agencies regarding use of so-called select agents, biological pathogens that have the potential to cause serious harm but which also are used in research labs seeking to find cures and treatments for deadly diseases.
The report summarizes a two-day meeting convened in January by AAAS, the Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU). The meeting, supported by the Alfred P. Sloan Foundation, brought together university leaders, scientists and representatives of the national security community to discuss some of the security challenges facing academic institutions at a time when about 400 American laboratories are doing research involving select agents.
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While the report's recommendations do not necessarily reflect the views of the sponsoring organizations, they make clear the need to foster and expand communication between academic institutions and security agencies. “We're delighted to have been able to help catalyze this discussion between research universities and the national security community, both of which learned a lot about the other through the course of this meeting,” said Gerald Epstein, director of the AAAS Center for Science, Technology and Security Policy.
Some scientists at the meeting argued that federal security measures—such as requiring security clearances for equipment that poses minimal threat of misuse and guards for securing harmless organisms—may have damaged the credibility of regulators and policy-makers among researchers. They also noted that security officials sometimes approach the scientific community with concerns about amorphous national security threats rather than acknowledging or addressing the more tangible threats that institutions routinely face, such as cyber crimes, eco-terrorism, and campus violence.
The report asks for broader input from scientists during the policy development process and also acknowledges that leaders of research institutions need to provide high-level support for good research and security practices at their laboratories.
“The pace of science, especially in the biological arena, is advancing very rapidly,” the report says, “and federal oversight bodies may not be nimble enough to respond accordingly.” It says that laboratory biosafety and security, “including physical and personnel security, may be best addressed by the research institutions themselves and by using a combination of guidance and regulation.”
Policies need to stress safety awareness and a security mindset over mere compliance with current audit mechanisms, which often consist of “checking boxes” on paperwork, the report says. Instead, “a system based on performance may be more effective at achieving a cultural shift that is more sensitive to biosecurity risks and concerns,” it says.
Much of the current policy discussion about laboratory biosecurity focuses on personal responsibility by individual researchers and the ability of laboratory heads to identify suspicious behaviors or activities. But such discussions provide “little guidance on the roles and responsibilities of scientists and institutional administrators,” the report says, including how to characterize the dual-use potential of various research activities, how to weigh their risks and benefits, how to identify suspicious behavior, and how to get the word out about research methods or findings that could be exploited for misuse.
There was support by participants in the January meeting for more formal mechanisms to share best practices in biosafety and biosecurity, but also some concern that publicizing such practices with the media or the community could impede frank sharing of information.
Research institutions need to do a better job explaining the measures they already have in place to promote safe, secure research in the biosciences, the meeting report says. Institutions have administrative staff and procedures—such as biosafety committees and Institutional Review Boards—to oversee biological research and screen personnel, it says, but “these programs are not marketed or described using terms familiar to the security community, leading the security community and the public to believe that adequate procedures are not in place to address current or emerging biosecuity concerns.”
Research institutions need to foster relationships with their neighboring communities, explaining the type of work they do and the measures they have in place to protect their employees, students, animals used in research, and the public, the report says. All institutions must recognize that communication is an important part of building public trust, it says.
The report suggests that universities establish or expand threat and risk assessment teams to help address and manage the possible hazards that could arise on their campuses. It notes that campus shootings, such as the mass killing of students on the Virginia Tech campus in 2007, prompted several universities to form threat assessment teams made up of community residents and well as university members.
The report also urges the federal government to develop standardized models for laboratory risk assessments and calls for integrated inspections by federal agencies with oversight on institutions performing select agent research. The Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service do have an integrated inspection program. The Department of Defense and the Department of Homeland Security conduct separate inspections. The report also urges the government to build a common regulatory structure for radiation security, chemical security, and select agent regulations.
The report provides useful background on the competing responsibilities—and differing perceptions—of the research and security communities and describes the leading legislative and executive branch efforts to strengthen laboratory biosecurity. It notes that the congressionally mandated Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism recently released a report card urging congressional action on biosecurity concerns. The report card, scoring the initial response to the commission's 2008 report, “A World at Risk,” gave the federal government a barely passing grade for improving the security of high containment laboratories.
Both the House and Senate held hearings late last year that focused on the commission's report and the threat of a biological attack. Senator Joseph Lieberman (I-Connecticut), chair of the Senate Homeland Security & Governmental Affairs Committee, and Senator Susan Collins (R-Maine), the committee's ranking Republican, introduced a bill (S. 1649) that responds to the commission report, including the recommendation that regulation of registered and unregistered high containment-laboratories be consolidated under one agency, preferably the Department of Homeland Security (DHS) or the Department of Health and Human Services (HHS).
The Senate legislation does not follow that recommendation precisely but creates a tiered system for listing select agents based on the level of risks to national security and public health. The bill would require HHS and the U.S. Department of Agriculture (USDA) to create a new “Tier 1” designation for select agents and pathogens that pose the greatest threat for a biological attack. This new level would be based on intelligence and risk assessment analysis conducted by DHS and the intelligence community and overseen by DHS.
The bill also requires DHS to establish new biosecurity standards for laboratories that conduct research on these “Tier 1” pathogens and would utilize a negotiated rule-making process to allow consultation with the scientific research community before finalizing the standards. A companion version of the Lieberman-Collins bill has been introduced in the House (H.R. 5057).
Also, Representative Peter King (R- New York), ranking Republican on the House Committee on Homeland Security, and Rep. Bill Pascrell (D-New Jersey) are preparing a House bill that is similar to the Lieberman-Collins bill but which—as many scientists have urged—reportedly retains oversight of the select agents program under HHS and USDA rather than moving it to DHS.
The AAAS/AAU/APLU report notes that, with the exception of biological select agent and toxins policies, the federal government often prefers to develop administrative guidance on biosecurity concerns rather than proposing new regulations or laws. The aim is to provide guidance that may be effective as security risks evolve and technologies emerge, while not increasing the administrative and financial burden. But, the report says, such guidance is still considered de facto regulation by the academic community, requiring additional financial and administrative resources for compliance.
3 May 2010