Regulating the Sale of Dangerous Genes

One of the increasingly important issues for bioterrorism is monitoring and screening dangerous genes and toxins sold through biotech companies in the gene-synthesis industry. There is currently debate within this industry over what form such regulation should take. One group based in Europe, The International Association of Synthetic Biology (IASB), proposes gene-screening standards. IASB wants both an automated step, in which requested genes are compared to a database of potentially hazardous genes, and those with too many commonalities are flagged, and a human step in which potentially dangerous matches are evaluated by an expert. However, two companies, including one based in Menlo Park, propose only having the automated step, eliminating human verification.

This proposal worries many in the industry because some genes that are potentially dangerous may not appear in the database and because developments in gene splicing may create new dangers that are not reflected in the computer database. Of greatest concern for the companies is cost; having human verification as well as automated verification would require more money. If several companies adopt only the automated verification, the industry as a whole would tend toward this "lowest common denominator" of regulation in order for their prices to stay competitive.

The issue will be resolved in November when the IASB will meet to discuss adopting an industry wide code of conduct. It is hoped that the US government, which has been studying possible codes of conduct, will offer an opinion that will help guide the proceedings. Human verification would likely be more effective than a computer database alone, but any industry wide code of conduct seems reassuring that dangerous genes cannot be purchased as easily by just anyone.

http://www.nature.com/news/2009/090831/full/461022a.html