The select agent rule and its impact on clinical laboratories

The Select Agent Rule was established to protect public health and safety and was designed specifically to address the possession, use, and transfer of select agents and toxins. It was published in the Federal Register Friday, 18 March, 2005, and became effective on 18 April, 2005. This rule applies to virtually all laboratories, including clinical, diagnostic, and research laboratories. What has been somewhat unclear is the impact of this rule on the day-to-day operation of clinical laboratories that may, in the course of routine analysis, isolate one of the select agents. Clearly, clinical microbiologists should be aware of the risks associated with manipulation of any of the select agents, the precautions necessary to protect laboratory personnel, and particularly, the regulatory requirements imposed upon those laboratories that choose to maintain and work with these agents. Thus, understanding the Select Agent Rule should be a goal of clinical microbiologists and laboratory directors that oversee diagnostic and research procedures. For most clinical laboratories, there should be no need to register with the Select Agent Program, as long as suspected isolates of select agents are forwarded to a registered reference laboratory for confirmatory identification and stock cultures of these agents are not maintained. Details of the application process are available on the internet at http://www.cdc.gov/od/sap/.