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Fall/Winter 2010 Vol. 10 Number 3



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A Brighter Line for Oversight

Research in the life sciences has led to medical advancements and improvements in the nation's defense against biological threats like smallpox and anthrax. Yet, such research raises fears about its possible misuse to commit acts of bioterrorism or to create new or more deadly biological weapons.

One particular area of concern is research involving a group of bacteria, viruses, toxins, and fungi designated as "Select Agents" that pose the greatest threat to public health and safety. Several universities, institutions, and government agencies maintain stocks of these agents, and federal regulations are in place to prevent their loss, theft, or misuse.

However, with continually evolving technologies, the line between what should and should not be classified a Select Agent is becoming fuzzier. Technologies that can generate or "synthesize" any DNA sequence make it easier and less expensive for researchers, industry scientists, and amateur users to modify various organisms. This leads to questions about the potential to assemble or modify a Select Agent -- or produce a new and more dangerous one -- from fragments of DNA sequences bought from different companies.

Amid these concerns, the National Research Council investigated the practicability of replacing the current Select Agent list with an oversight system that could predict whether a particular DNA sequence could be used to produce an organism that should be regulated as a Select Agent.

The resulting report finds that such a predictive system is not feasible right now. For the foreseeable future, any threat stemming from synthetic biology is far more likely to come from assembling or modifying Select Agents, rather than constructing previously unknown ones. Therefore, modernizing the regulations to define Select Agents by their gene sequences is a better way to go, the committee said, calling this approach "sequence-based classification."

The system could be used to determine if a DNA sequence might be close enough to that of a listed Select Agent to raise a cautionary alert or "yellow flag." For instance, a DNA synthesis company might use the system's database to screen orders and investigate who placed a questionable one and why.

This system would not be regulatory in nature but intended to serve as a resource for information sharing instead. Although it may improve the current practice, the system does have limitations, the committee noted, and emphasized that its potential benefits should be considered and weighed against the cost and complexity of implementation.
--  Jennifer Walsh



Sequence-Based Classification of Select Agents: A Brighter Line. Committee on Scientific Milestones for the Development of a Gene Sequence-Based Classification System for Oversight of Select Agents, Board on Life Sciences, Division on Earth and Life Studies (2010, 234 pp.; ISBN 0-309-15904-0; available from the National Academies Press, tel. 1-800-624-6242; $50.50 plus $5.00 shipping for single copies).

The committee was chaired by James W. LeDuc, professor of microbiology and immunology, and director of the Galveston National Laboratory and program on global health, Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. The study was funded by the National Institutes of Health.



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