Government tightens controls on lab agents

New rules issued this summer are requiring 190,000 research and diagnostic laboratories, including veterinary facilities, to notify federal authorities if they are in possession of any of 36 "select" biological agents.

The notification rules were signed off by President George W. Bush aspart of the Biopreparedness and Response Act of 2002 and published in TheFederal Register earlier this summer. The published document states "theAct specifies that the Secretary of the Department of Health and Human Servicesestablish and maintain a list of biological agents and toxins that havethe potential to pose a severe threat to public health and safety."

Laboratories had until September 10 to comply with and notify the Centersfor Disease Control and Prevention of any of the so-called "select"agents, which include viruses such as eastern equine encephalitis, ebolaand tick-borne encephalitis complex, bacteria such as Bacillus anthracisand Rickettsia rickettsii and toxins such as Botulinum neurotoxins and Clostridiumperfringens epsilon toxin.

Dr. Ron Atlas, president of the American Society for Microbiology whohas spoken publicly on the impact of such regulations, says that a numberof veterinary labs probably do have possession of agents isolated from ananimal some time ago, which may be on the list. The list not only includesthe traditional CDC human pathogens, but also animal pathogens.

He says to watch for a future proposal from the U.S. Department of Agriculturethat will single out specific plant and animal pathogens.

"If you do not register and you are in possession, there will besevere criminal penalties - jail and fines," says Atlas, adding thatyou must have a legitimate reason for possession.

Under the Bioterrorism Act, certain individuals in the United Statesare restricted and may not possess or have access to the agents listed inthe rules. "For example, if you're a foreign national from a countrythat the U.S. declares is in support of terrorism, you may not have access.

"That could affect a veterinary lab that had any of these agents,"says Atlas. "If a veterinary lab was retaining for reference purposes,let's say a cultured anthrax, they'd have to register. They'd have to ensurethat no one who is restricted had access to those cultures. That will requiresecurity measures in all likelihood."

Overall, Atlas doesn't view the new federal rules as having a momentousimpact. "On the other hand it is an additional regulatory burden weare paying to protect against terrorism," he says.

The list is not final, because the CDC is still allowing for possibleexemptions to the list. It is posted on its Web site at www.cdc.gov informationon current registration of agents.