Clinical specimens exempt from CDC regs
Bugs must ship to approved sites
Concerned that terrorists may obtain pathogens and cause outbreaks of infectious diseases, federal health officials are tightening oversight on the shipment and receipt of a select group of deadly viruses, bacteria, and toxins.
The move, however, should not greatly affect clinical labs in hospitals and health care systems, which are generally exempt from the proposed tracking and reporting requirements by the Centers for Disease Control and Prevention in Atlanta.1
"It specifically excludes clinical specimens or specimens sent for reference purposes," says Stephen Morse, MD, associate director of science in the CDC division of AIDS, sexually transmitted disease and tuberculosis laboratory research. "Also, the agents on the list are generally not those that would be routinely isolated in any hospital.
"So it is really not going to have much of impact on them unless they happen to isolate one of the agents that is on the list. If they need to send it for confirmation that is OK, but they can't just send it around to anybody. [It has to be] a licensed site."
Published as a proposed rule in the Federal Register, the regulation is now under review for final revisions.1 Of special concern are pathogens and toxins causing anthrax, botulism, brucellosis, plague, Q fever, tularemia, and all agents classified for work at biosafety level four. (See list, p. 103.)
"It specifically regulates the shipment of just those agents," Morse says. "So if it's not listed it's not covered."
The CDC proposed the rule to place additional shipping and handling requirements on laboratory facilities that transfer or receive select infectious agents "capable of causing substantial harm to human health."
The requirements primarily apply to laboratory facilities such as those operated by government agencies, universities, research institutions, and commercial entities. If finalized as proposed, facilities requesting select infectious agents will have to register with the U.S. Department of Health and Human Services in Washington, DC.
According to Morse, the proposed changes were prompted by a case last year in Ohio involving an alleged white supremacist who used forged letterhead on correspondence to obtain cultures of bubonic plague from a biotechnology company.
"Because of that, and how easy it is for some people to get a hold of these agents, there was a committee established to tighten things up without undue hardship on the scientific community," he says.
Specifically, the proposed rule is designed to:
* collect and provide information concerning the location where certain potentially-hazardous infectious agents are transferred;
* track the acquisition and transfer of the specific infectious agents;
* establish a process for alerting appropriate authorities if an unauthorized attempt is made.
Reference
1. Centers for Disease Control and Prevention. Additional requirements for facilities transferring or receiving select infectious agents. Federal Register: June 10, 1996; 61(112):29,327-29,333. *
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