Tighter Rules on Hazardous Agents Sought

Laboratories that possess hazardous agents will have to register with the government under regulations released Tuesday.

Under old rules, only labs that transferred or received specimens posing a threat to public, animal or plant health or safety were required to register. That left a giant loophole. For example, federal officials investigating last year’s anthrax attacks initially had no idea how many labs possessed anthrax.

The new rules, being published in the Federal Register, require anyone who possesses any of 38 agents to register with the national Centers for Disease Control and Prevention or the Department of Agriculture and to undergo an inspection to show that security measures are in place. The list includes bacteria that cause anthrax and plague and viruses such as ebola, as well as lesser-known agents.

The rules also require all labs to develop biosecurity plans and background checks on people who work with select agents.

The regulation is open for public comment over the next 60 days, with a forum set for Monday in Washington where people can express concerns. If changes are not made in response to the comments, the rules will become final Feb. 7. Complementary regulations were announced Tuesday by the USDA and the Department of Health and Human Services.

“This new rule strengthens our ability to ensure that essential research on these agents continues while making certain they don’t fall into the wrong hands,” Tommy G. Thompson, Health and Human Services secretary, said in a statement.

Last week, the CDC issued guidelines to help labs comply with the tighter security requirements. Among the recommendations: Monitor areas where pathogens are stored, keep specimens locked up and allow access only to people authorized to work with the agents.