Government Guidance for Gene Firms to Prevent Bioterrorism

The U.S. Department of Health and Human Services has proposed a set of guidelines for how providers of custom-made DNA sequences should do business. The proposal is the first comprehensive guidance issued by the government to tackle bioterrorism concerns stemming from the rapidly developing synthetic genomics industry, which some security experts believe could allow terrorist groups or lone evil-doers to develop bioweapons simply with materials purchased over the Internet.

The main recommendation that gene synthesis companies screen their clients and the DNA sequences requested by them. Besides establishing the identity and institutional affiliation of customers, companies should watch out for red flags such as a client placing several orders of the same sequence within a short time frame, or wanting to pay by cash, or requesting that the product be mislabeled. Foreign clients should be screened against terrorist databases and other lists of concern.

The proposed guidelines also suggest a specific approach to screening orders: instead of looking for an exact match between the requested sequence and sequences that encode specific features of dangerous pathogens—that is, select agents—companies should use what the government calls a "best match" strategy. That would involve an analysis to find out if the requested sequence is statistically closer to a select agent or to a non-select agent; if it turns out to be the former, the company should follow up with the client to learn more about what the material is being requested for. Suspicious orders should be reported to the government, and all paperwork should be archived for 8 years.

The proposal seems like an endorsement of the self-governance approach favored by industry. In fact, the guidelines seem to have been pre-empted by an announcement earlier this month from a consortium of gene synthesis companies pledging to take some of the same steps. Environmental and arms control groups are likely to press the government to convert the guidelines into mandatory rules. The comment period for the proposal ends 26 January.