The aftermath of anthrax attacks following the horrific 9/11 events increased fear that terrorists could acquire deadly pathogens from legitimate U.S. laboratories, which led to a series of laws and regulations directly impacting clinical microbiology laboratories. The potential for bioterrorist acts mandated increased awareness, vigilance, training and preparedness by clinical laboratorians who have been ill prepared at times to deal with public and law enforcement demands for analyses of environmental samples. The worried well have, at points, overwhelmed their capacity and disrupted normal services. Some personnel required additional training, and operating protocols had to be developed.
The American Society for Microbiology (ASM) supported the development of measures to reduce the threat of catastrophic acts of bioterrorism, while ensuring critical performance of diagnostic laboratory functions that protect individuals and the nation against infectious diseases. Enhancement of clinical and public health laboratories is key to the nations biodefense capabilities, so the ASM worked with the Centers for Disease Control and Prevention (CDC) to develop protocols for diagnostic laboratories to recognize and handle major biothreat agents. These protocols provide guidance for clinical laboratories, which focus on medical diagnoses, and serve as sentinels for bioterrorist attacks by ruling out and referring suspect samples to the Laboratory Response Network (LRN). The ASM sought adequate resources for the CDC to reinvigorate our public health system, including all LRNs and associated labs.
The ASM supported the development of a limited system of constraints on material and information exchange to reduce the potential for their misuse by terrorists. As that regulatory oversight was developed, ASM sought to ensure that it did not place an undue burden on clinical labs and that it did not interfere with the laboratory diagnostic activities that represent essential defenses against bioterrorism and infectious diseases. The ASM support for laws and regulations within the United States that limit who may possess, and the conditions under which one can have access to certain pathogens and toxins (select agents), was conditioned on appropriate provisions to guarantee unfettered functioning of clinical diagnostic labs, enabling them to isolate pathogens without pre-registration.
Some provisions of the USA Patriot Act and the Biopreparedness Act, however, potentially impact clinical labs. The USA Patriot Act (Oct. 26, 2001) contains a section, which ASM supported, that makes it an offense for a person to knowingly possess any biological agent, toxin or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by prophylactic, protective, bona fide research or other peaceful purpose. Since clinical labs have been the sources of the agents used in prior acts of bioterrorism or biocrimes (e.g., the 1989 use of
Salmonella by the Rajneesh cult in Dalles, OR), they must exercise appropriate oversight as to who is given access to any pathogen which can be misused to cause harm. This Act restricts certain individuals from possessing select agents, among them an alien illegally or unlawfully in the United States or an alien who is a national of a country for which the Secretary of State has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism.
The ASM supported the Biopreparedness Act (June 12, 2002), which incorporated the restrictions of the USA Patriot Act and also mandated that the Departments of Human Health Services (HHS) and Agriculture (USDA) institute regulations for the possession of select agents. This Act gives a clinical lab one week following identification of a select agent to destroy it or transfer it to a registered lab, thus complying with the Acts regulatory requirements while continuing to perform diagnostic activities. Clinical labs wishing to retain select agents as clinical specimens or reference standards must meet all of the registration requirements of the Biopreparedness Act, including imposing strict biosecurity procedures and obtaining Department of Justice clearance for all individuals with access to the select agents. The CDC and USDA must maintain accurate tracking of the acquisition, transfer and possession of these select agents, and must establish safeguards and biosecurity procedures to be followed by institutions possessing select agents. The FBI is responsible for conducting security risk assessments of individuals seeking access to listed agents and toxins, and individuals or entities seeking to register under the Act.
The Biopreparedness Act, a new regulatory burden, should have minimal impact. Most clinical labs are unlikely to possess select agents, electing to transfer or destroy cultures of any such organism following isolation and identification. The greatest impact is likely to be on labs in the western United States where plague, tularemia and coccidioidomycoses occur. The inclusion of
Coccidioides immitis on the select agent list presents a significant problem, because this fungus is frequently isolated and is often retained as a reference culture. A number of the southwestern U.S. labs may need to register with all the regulatory burden that imposes for authorization to possess select agents. In the era of bioterrorism, that is the price which must be paid for increased security.
Ronald Atlas is graduate dean and professor of biology at the University of Louisville; past president of the American Society for Microbiology; and co-director of Center for the Deterrence of Biowarfare and
Bioterrorism.
As has been the history of MLOs Washington Report, this space will be
devoted in 2003 to keeping readers abreast of ongoing issues and new legislation affecting the clinical laboratory and its professional managers and technicians. If there is a particular legislative question or a legislative topic of special interest to your organization, please e-mail:
[email protected].
September
2003: Vol. 35, No. 9
© 2003 Nelson Publishing, Inc. All rights reserved.
