The American National Standards Institute (ANSI) will be collecting comments through Sept. 10 on its new standard, Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities, also known as ANSI Standard Z9.14-2013. The 127-page document provides guidance for the inspection and testing of ventilation system components of new or existing BSL-3 and ABSL-3 laboratories, including research, pharmaceutical, and insectary facilities. It does not apply to BSL-3-Ag or plant research facilities. The ANSI standard is compatible with existing national and international health and safety regulations and codes, and in fact references them throughout.
The document was developed to offer standardization, uniformity, and consistency in the testing and verification of ventilation systems in high-containment labs through the use of a risk assessment and performance-based approach. It covers such issues as supply and exhaust systems, directional airflow, engineering controls (including biosafety cabinets and other primary containment devices), air filtration, exhaust stacks, building automation systems, failure modes to check, and other issues that might affect the ventilation systems.
“What are we as owners asking when someone comes into our facility and we tell them to test and verify our ventilation systems?” says Louis DiBerardinis, director of Environmental Health and Safety at the Massachusetts Institute of Technology and vice chairman of the ANSI committee that drafted the standard. “The value in this standard is that it pulls together all the information in one place and tells you, ‘Here are all the things you shall look at.’ Then it provides guidance, advice and/or recommendations on each of the issues.”
What the document is not is almost as important as what it is, says DiBerardinis. It is not intended to be used as a comprehensive laboratory biosafety or BSL3/ABSL3 standard, a mandatory standard, a replacement or alternative for existing regulatory requirements, an accreditation and/or certification document, or a design or commissioning document.
“You’re not going to find many numbers specified in this document, like air changes per hour,” he says. “It’s not prescriptive like that.” There are some specifics recommended that can be adopted by the facility owner based on the risk assessment and applicability for each facility.
DiBerardinis says there was concern early on in the process among owners of older BSL-3 labs that the standard would in fact be prescriptive and that they would have trouble complying. Instead, the committee has taken care to focus on methodologies that help each lab assess its own risk and determine the best way to mitigate that risk.
“For example, the standard says you have to maintain directional airflow but it doesn’t specify how you do it, or what the pressure differential is, or what other requirements are,” he says. “It gives guidance and provides references for more detail. You, as the owner, need to make those decisions based on your own risk assessment, and document why you made those decisions.”
Once all comments on the standards are collected, they will be compiled and reviewed by the full Z9 committee. If the public feedback generates any significant changes in the document, the standard will be released for a second round of review and comment before it is finalized. If not, the standard will be forwarded to ANSI for final approval.
Copies of the draft standard are available for $70 from the American Society of Safety Engineers (ASSE), which is managing the review process. (A final copy of the standard is free to anyone who purchases this preliminary draft.) Checks made out to ASSE, as well as comments on the report (copied to email@example.com) may be sent to:
Tim Fisher, CSP, CAE, CHMM, CPEA, ARM
Director, Practices and Standards
American Society of Safety Engineers (ASSE)
1800 East Oakton Street
Des Plaines, IL 60018
By Lisa Wesel