The American Industrial Hygiene Association (AIHA) and the American National Standards Institute (ANSI) have embarked on an initiative to develop a national standard entitled “Testing and Performance Verification Methodologies for Biological Safety Level 3 (BSL-3) Laboratories,” known as ANSI/AIHA Z9.14. After peer and public review and approval, this standard will serve the over 1500 registered BSL-3 laboratories in the United States as a standard to establish uniform, minimum testing and performance verification criteria to maintain the integrity of all containment laboratories in order to protect occupants and the environment. The standard is expected to encompass a systematic review and evaluation of all safety design features, operations, and processes including engineering controls, personal protective equipment, building and system integrity, standard operating procedures, and administrative controls.
The methodology will provide guidance to ensure that all reasonable facility controls and prudent practices are in place to minimize, to the greatest extent possible, the risks associated with laboratory operations and the use of biohazardous materials. It will provide a method to account for research integrity and validate that the facility can continue to perform at the safety level for which it was intended. As well, the standard will serve as an umbrella methodology that ensures, validates, and accounts for the completion of all other necessary and required processes or certifications. Representation on the ANSI/AIHA Z9.14 committee is evenly balanced between academia, industry, manufacturers, government, and organizations such as The American Biological Safety Association (ABSA); European Committee for Standardization (CEN); and the Controlled Environment Testing Association (CETA). The co-chairs of the committee are Farhad Memarzadeh, from the National Institutes of Health and Lou DiBerardinis, from Massachusetts Institutes of Technology. The ANSI/AIHA Z9.14 committee is divided into four working subcommittees chaired by experts from the containment community. These are: Administrative Controls Subcommittee: Stefan Wagener; SOPs and Documentation Subcommittee: Bruce Whitney; Visual Inspection Subcommittee: Krishnan Ramesh; Testing and Performance Subcommittee: Paul Langevin.
