Congress considers greater federal oversight of labs handling select agents

Jan. 1, 2002

On Capitol Hill, lawmakers are considering legislation to increase federal oversight of laboratories
that process microbes with potential use as biological weapons. The aim is to improve the ability of the Department of Health and Human Services
(HHS) to prevent or respond to public health emergencies created by terrorist attacks.

The legislative push is fueled by the growing concern of law enforcement agencies. They worry about the lack of sufficient data to investigate terrorist attacks involving agents like anthrax, says Janet Shoemaker, director of the office of public affairs for the American Society of Microbiology

The legislative proposals are designed to create a paper trail, says Mark
Birenbaum, Ph.D., administrator for the American Association of Bioanalysts
(AAB) in St. Louis, MO, so that the U.S. knows where these organisms are. But, he says, no matter how select agents are regulated, it would be easy to remove a culture from a lab. 

A select agent is defined as a microorganism (virus, bacterium, fungus,
rickettsia) or toxin, including genetically modified or genetic material from those select agents. 

A number of legislative proposals are under consideration in Congress to tighten federal oversight. One measure would provide HHS with new authority to regulate the possession, use, and transfer of select agents that the HHS Secretary finds to be a national security threat. It would require research laboratories that possess these agents to register with the Centers for Disease Control and Prevention
The measure calls on the HHS Secretary to establish and maintain a list of biological agents and toxins that are determined to be a national security threat. Violations would be subject to civil penalties of up to $250,000. Congress also is considering legislative proposals to require laboratory workers who handle select agents to undergo background checks and be registered with the government for specific projects.

Current law needs more muscle

Currently, the Antiterrorism and Effective Death Penalty Act of 1996 regulates the shipment of select agents that could be used for bioterrorism purposes. That law directed the HHS Secretary to maintain a list of biological agents that have the potential to pose a severe threat to public health and safety. There are approximately 40 microorganisms and toxins that have the potential to cause substantial harm to human health that are currently subject to the laws regulations. 

Under this law, research laboratories only have to register with the CDC if they ship select agents, not if they possess them in the laboratory. 

In recent testimony, Ronald M. Atlas, Ph.D., president-elect of
ASM, told the Senate Judiciary Subcommittee on Technology, Terrorism and Government Information that ASM supports registration with the CDC of every research laboratory that possesses and retains viable cultures (preserved and actively growing) of select agents. Atlas also is professor of biology and graduate dean at the University of Louisville in Kentucky. 

Under the registration proposal, research labs would be required to maintain records of authorized users and ensure they are properly trained.

Atlas told the subcommittee that some 20 to 30 university labs nationwide regularly work with various strains of anthrax, but an estimated 250 to 350 domestic facilities handle different types of select agents.

The legislative proposals under consideration would continue to exempt clinical laboratories from the registration requirement unless the clinical lab plans to hold on to the specimen, says Shoemaker. If the clinical lab does keep the specimen, it would also be required to register with the
CDC, she explains.

ASM has worked closely with Senate staff to continue the exemption that exists in current regulations for clinical labs, says Shoemaker. Often these labs do not know what they have, and when they do know, they destroy or dispose of the agent according to specific regulations, she adds. 

Since the events of Sept. 11, there is overwhelming sentiment both in Congress and from the Bush Administration for additional federal oversight of laboratories possessing select agents, says Shoemaker. It is just a matter of time before legislation passes, she says.

Atlas told the subcommittee that policy measures intended to limit access and use of dangerous biological agents may adversely affect legitimate research and clinical diagnostic testing. He asked lawmakers to strive for the proper balance between safeguards that prevent bioterrorists from access to select agents while not burdening important research or clinical diagnostic testing.

HHS maintains that it is fully aware of this. The Departments Deputy Secretary Claude A. Allen told the subcommittee that it is critical for safeguards to be carefully balanced against other important societal concerns, notably the need to support and encourage legitimate and important research involving these substances.

Joan Szabo is a Washington, DC, freelance writer specializing in healthcare issues. She has been writing the Washington Report column for MLO for the past five years.

2002 Nelson Publishing, Inc. All rights reserved.