GOVERNMENT & POLICY NEWS
ANALYSIS
BIOTECHNOLOGY: A TWO-EDGED SWORD Science, national security communities must act to balance security, legitimate research
T
HE JANUS-FACED NATURE OF
biological research became evident during the anthrax attacks of last fall. The public quickly realized that research which leads to the development of drugs and vaccines to counter bioterrorism could also be used to develop the lethal biological agents themselves. Congress has long recognized this dual nature, and to protect public health and enhance national security, it has responded over the years by passing laws that regulate the bioscience enterprise. After Sept. 11,2001, it passed the U.S.A. Patriot Act, which bans the inappropriate use of a selected list of agents—including genetically modified organisms—but permits their use for legitimate research. Last week, President George W Bush signed legislation Congress enacted on May 23 that requires facilities possessing, using, or transferring 42 select biological agents and toxins to register with the Department of Health & Human Services. The bill also requires security checks on personnel working with these agents, extends controls to agents that threaten plant or animal health, and imposes civil and criminal penalties for violations. The American Society for Microbiology worked closely with Congress during the crafting of this legislation. And ASM intends to work with federal agencies to ensure that regulations implementing the legislation balance security concerns with protection of legitimate scientific research. In addition, the National Academy of Sciences has recently formed a Committee on Research Standards & Practices To Prevent Destructive Application of Advanced Biotechnology, chaired by Gerald R. Fink, a founding member of the Whitehead Institute and a genetics professor at Massachusetts Institute of Technology. The committee will review current U.S. regulations and institutional arrangements governing research on dangerous pathogens now being conducted in federal, university, and industry labs. It aims to come up with a set of recommended changes to ensure that legitimate research can con22
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2002
tinue while illicit applications are averted. This 18-month effort is supported by the Nuclear Threat Initiative and the Sloan Foundation. The U.S. government, recognizing the health and economic benefits of fundamental biological research, has prudently steered clear of restricting its conduct and dissemination. A 1985 National Security Decision Directive codified U.S. policy on dissemination, and it remains in effect. But, Gerald L. Epstein warns, the fast clip of biotechnology developments could be subverted to produce new, more subtle biological agents that affect health, behavior, and even consciousness. And this potential, he contends, could force the Epstein government to reexamine its policy Epstein is currently a scientific adviser to the Defense Threat Reduction Agency; he was formerly a member ofthe White House Office of Science & Technology Policy and the Congressional Office of Technology Assessment. At a recent seminar on responding to the challenge of biological weapons sponsored by the Chemical & Biological Arms Control Institute, he argued cogently that the scientific enterprise, in its own self-interest, needs to take the reins at self-governance. If it doesn't, he warned, government could impose "more formal constraints through regulation, funding policy, or law," though he thinks informal selfgoverning mechanisms are more likely Although self-governing measures might be perceived as "mfringing upon the freedom of scientific inquiry" Epstein cites the 1975 Asilomar conference on recombinant D N A as precedent. It led researchers to impose a voluntary temporary ban on certain genetic engineering techniques, create a National Institutes of Health Recombinant D N A Advisory Committee, and set up biosafety committees at each institute conducting such research. The Asilomar process, Epstein notes, is not a perfect frame on which to fashion
self-governing measures for today's research. Asilomar was constructed, he says, to guard against "unintended consequences but not the intentional use of scientific information to cause harm." And it addressed research methods, he adds, not research results or communication. The challenges to self-regulation are many and difficult. The biological and technical base is growing and is available to the international community Relevant equipment is attainable worldwide and is in widespread commercial use. And the relevant pathogens can be found in the environment. POLICY MEASURES, therefore, are likely to affect many legitimate activities beyond z those intended for control. £ Especially hard hit could be ^ the academic and commercial < sectors that conduct much of « the biotechnology research t today £ Epstein lists four elements g ofgovernance he believes the k biological community should * be debating today: constraint, opacity transparency, and responsibility Are there areas of research so dangerous that they shouldn't be undertaken at all? Should criteria be established for determining whether some research warrants restrictions on dissemination? Are there research areas that demand extraordinary obligations for openness? How does the community balance scientific freedom and social responsibility? What obligations do scientists have to identify or clarify suspicious activities by others? The debate over governance measures that are useful and feasible may begin in the scientific community, but the dialogue, Epstein says, will have to be broadened to include the industrial, clinical, law enforcement, and national security communities. This dialogue, he says, "is a necessary, but not a sufficient condition for success." It may turn out that mechanisms that are both useful and feasible—read implementable—for lessening the probability of developing advanced biological weapons are not possible, Epstein cautions. "But that should be the conclusion—not an assumption—reached after deliberation and reflection," he says. If both conditions turn out not to be possible, the scientific community has to make that case "to the other communities in a way that is not dismissive of their concerns."—LOIS EMBER HTTP://PUBS.ACS.ORG/CEN
