Certification requires a conclusive and effective commissioning process

Every laboratory in the U.S. that uses select agents listed by the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) must undergo a certification process before conducting research. This requirement has caused facility owners to approach commissioning firms to provide a certification service for their biocontainment facilities. Although commissioning is a significant part of certification, it is part of a larger effort and process. The purpose of this article is to describe the certification process in general terms and the specific role of commissioning in that process.

This article refers to the “facility owner” throughout. The owner may be a university; a local, state, or federal government body; or other institution. Federal or military laboratories may be exempt from formal certification, but use their own agency’s program to self-certify. The context of the word “owner” refers to the party or organization that has overall responsibility for the program, the staff, and for hiring consultants and contractors to design, construct, and verify operation of the laboratory for research using select agents.

The goal of certification is to prove compliance with the NIH-CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), USDA 242-01M ARS Facilities Design Standards, the NIH Design Policy and Guidelines, and/or the World Health Organization (WHO). Appendix D of the BMBL 4th Edition lists select agents.

One of the more challenging aspects of certification of Biosafety Level-3 (BSL-3) and higher laboratories is that no formal, publicly-distributed checklist of certification tasks and requirements exists. The above publications are not policies or standards, but are guidelines that contain recommendations followed as part of a voluntary compliance program. Government agencies place the responsibility with the end user to develop a detailed description of the building, its systems, and its methods to safely conduct research using select agents. A small number of consultants provide services to support facility owners to develop a formal process that leads to certification. Conclusive results of system tests must demonstrate that systems and standard operating procedures (SOPs) will provide environmental and biological safety without compromising the research.