Select Agents

Several university laboratories working with some of the deadliest biological agents are not complying fully with regulations to safeguard these so-called select agents from accidental release or intentional theft. The Department of Health & Human Services Office of Inspector General reviewed the compliance of 15 labs with select-agent security regulations for the 12 months beginning in November 2003. Assistant IG Joseph J. Green would not tell C&EN how these 15 labs were selected from the pool of 96 labs working with such select agents as the anthrax bacteria and botulinum neurotoxins.

Eleven of the 15 unnamed labs were out of compliance with regulations in at least one of five areas. Eight of the 11 labs, for example, had weak inventory and/or access records. Six labs had weak access controls, including procedures for access to select-agent areas, and/or weak security plans.

Three of the 11 labs had poor emergency response plans, the IG reports. Such plans are critical because "most of the labs working with select agents are located in urban areas," says Edward Hammond, director of the U.S. Office of the Sunshine Project, a bioweapons watchdog group.

Overall, five of the 15 labs studied were not in compliance in three areas, and one lab complied with none of the regulations. There is no indication in the IG report that any of these labs were sanctioned.

Out-of-compliant labs should, "at a minimum," have their federal support withdrawn or lose "eligibility for future federal support," says Rutgers University molecular biologist Richard H. Ebright, who monitors select-agent studies.