The Relationship of Microorganism Classification by US Government Guidelines to the Design pof Laboratory Facilities

When the first edition of the Biosafety in Microbiological and Biomedical Laboratories, (BMBL) series was published approximately 40 years ago its purpose was to provide a code of practice, guidelines and standards for the prevention of laboratory acquired infections to the laboratorian working in an infectious disease laboratory. The BMBL is based on the microorganism being worked on and is a set of recommendations, which are advisory. While this is true, many agencies in the US government have incorporated all or parts of the BMBL in their regulations. This has led to the BMBL being accepted as the de facto US standard for the design and operation of infectious disease laboratories. The concept of biosecurity has evolved as a result of concerns related o access to microorganisms by terrorists following the anthrax letters of October 2001. While related to biosafety the specific requirements vary from those related to biosafety and are based on laws passed by the US Congress. The Select Agent Program of the US Centres for Disease Control has been given the responsibility for codifying and enforcing these regulations. Both biosafety and biosecurity need to be considered in the design of a laboratory facility. The occasionally conflicting regulatory requirements can be best resolved by conducting a Risk Assessment, which takes into account the microorganisms and the manipulations planned for the laboratory. This is an essential step for both laboratory design and subsequent laboratory operation. (author)