ANSI/ASSP Z9.14-2020 Testing and Performance-Verification Methodologies for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Ventilation Systems

Abstract

The American National Standards Institute has approved the revised standard ANSI/ASSP Z9.14-2020, “Testing and Performance-Verification Methodologies for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Ventilation Systems”; the revision was published on March 31, 2020. ANSI/ASSP Z9.14-2020 focuses on performance verification of engineering controls related specifically to ventilation system features of BSL-3/ABSL-3 facilities. The revised standard has been enhanced to include new definitions; new guidance for developing corrective action plans and performing verification of conformance to regulations, appendices, risk assessment matrices, and checklists dedicated to performing a facility risk assessment; and numerous updates to the original content.

Since its original release in January 2014, American National Standards Institute (ANSI)/American Society of Safety Professionals (ASSP) standard Z9.14 has been extensively used both nationally and internationally to evaluate safety design features, operations, and engineering processes and controls in biosafety level 3 (BSL-3) and animal biosafety level 3 (ABSL-3) laboratories and animal facilities. The recommended testing methodologies the standard provides have proved invaluable in creating a standardized, uniform, and consistent approach to ensure that all reasonable facility engineering controls and prudent practices are in place to minimize, to the greatest extent possible, risks associated with laboratory operations and the use of biohazardous materials in a high-biocontainment facility.

ANSI/ASSP Z9.14-2020 continues to be the only guidance available that provides a methodology to verify ventilation systems in high-biocontainment facilities. Use of the standard is voluntary. It may be used in whole or in part as one component of a more extensive graduated and risk-based approach to reaching containment goals appropriate to the risk of the agent and the laboratory activity.

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Development of ANSI/ASSP Z9.14

The US Government Accounting Office ^1,2 identified the need for national standards to design, construct, commission, operate, and maintain high-containment laboratories using standardized, uniform, and consistent approaches. This was in response to the increasing number of both federally regulated and private high-biocontainment facilities, which were being built in the United States to address threats of emerging infectious diseases and biosecurity and biowarfare and to facilitate the testing of drugs and chemicals to treat and counter potentially lethal biological and viral agents.

The ventilation system of a BSL-3/ABSL-3 laboratory is specifically designed to prevent the unintended release of infectious biological agents that could cause human and animal exposures in either the working environment or the external environment. High-containment ventilation systems must therefore conform to current biocontainment guidelines and regulations (Biosafety in Microbiological and Biomedical Laboratories [BMBL], ³ The Association for Assessment and Accreditation of Laboratory Animal Care International ⁴ ). Federally funded US BSL-3/ABSL-3 laboratory design is guided by the criteria defined by the BMBL, the NIH Design Requirements Manual (if the facility is funded by the National Institutes of Health), the US Department of Agriculture Agricultural Research Service, select agent regulations, and local codes where applicable. Privately funded high-containment laboratories are encouraged to use similar design criteria and methodologies on the basis of the intended agents and procedures. Verification that containment systems are working as intended should be performed regularly, as defined by the institution, and the use of standardized methodologies such as those found in ANSI/ASSP Z9.14-2020 can provide a level of safety that might otherwise not be present for users, the community, and the internal and external environment.

The ASSP and the ANSI conducted an extensive “gap and needs analysis.” ⁵ They concluded that there was no single resource that provided a comprehensive testing methodology that could be used uniformly from one facility to another to verify the adequate performance of ventilation systems in these facilities. ANSI/ASSP Z9.14 was subsequently developed to provide one component of a more extensive, graduated, risk-based approach to reaching containment goals appropriate to the risk of the agent and the laboratory activity for the more than 1300 BSL-3/ABSL-3 laboratories that continue to operate in the United States. ⁶ The current revision, ANSI/ASSP Z9.14-2020, remains the only standard to date that takes a comprehensive approach to its subject matter, “Testing and Performance-Verification Methodologies for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Ventilation.”

Scope of ANSI/ASSP Z9.14

The scope of ANSI/ASSP Z9.14-2020 has not changed, but the existing content has been updated, and new sections, appendices, and checklists were added. The scope includes the following:

Directional airflow: a primary testable target

Airlocks and anterooms: double-door interlocking

Primary containment systems: focus on biosafety cabinets

Building ventilation system: alarm and interface with decontamination systems and other systems that would influence the automation

Heating, ventilation, and air conditioning testing: air-handling units, exhaust fans, redundancy in systems, dampers

Filtration

ABSL-3 and integration of individually ventilated cages, static caging systems, other elements, downdraft tables (ventilation implication)

Document validation (systems based)

Pressure reversal: provide methodologies that allow a facility to comply with the BMBL

Failure testing: addresses need, types, and frequency

Leakage issues related to heating, ventilation, and air conditioning

Qualifications of testers

Verification of conformance to regulations

Corrective action plan guidance

Updated definitions

Methodologies to perform risk assessment

Risk assessment and corrective action checklists

ANSI/ASSP Z9.14-2020 uses a risk assessment and performance-based approach and is adaptable to any size or type of BSL-3/ABSL-3 facility. The standard is designed to be fully compatible with biorisk management systems and national and international health and safety management systems without duplicating or contradicting their requirements. ANSI/ASSP Z9.14-2020 may be useful for (1) facilities that have similar functions and risks as BSL-3/ABSL-3 facilities but do not follow the same testing methods for ventilation, (2) facilities that cannot meet the ventilation recommendations of the most current BMBL when renovating or retesting, and (3) users who require help performing tests. It may be used in whole or in part as an adjunct standard operating procedure or along with other methodologies that may be available to ensure that the ventilation system in a BSL-3/ABSL-3 facility provides a safe environment for building occupants and the external environment.

Application and Use of ANSI/ASSP Z9.14

ANSI/ASSP Z9.14-2020 applies specifically to new or existing laboratories as well as research, pharmaceutical, and insectary facilities designed to perform at the BSL-3/ABSL-3 level. The standard should be applied if there has been a change of agents, procedures, or key personnel or a renovation, change of use, or decommissioning. ANSI/ASSP Z9.14-2020 addresses the inspection of the ventilation system components of any laboratory designed to handle agents and infected animals that require BSL-3/ABSL-3 containment as defined by the latest edition of the BMBL. The standard provides users with guidance on what ventilation system components should be inspected visually; verification procedures to ensure that system components provide for the safe operation of the facility’s ventilation system (ie, directional inward airflow, response to failures, minimizing leakage, etc); and methodologies to help comply with current local, state, and federal requirements, industry standards, and best practices.

The revised standard provides stepwise guidance to conduct an effective risk assessment. A comprehensive checklist has been added for users to confirm that the appropriate steps have been taken to ensure that the ventilation system operates as intended. The revision also contains more detailed procedures and risk matrices for use when deficiencies are identified through a risk assessment or in the course of testing and verification. Details are also provided to conduct iterative corrective actions until the deficiencies are resolved to management’s satisfaction. The basic guidance for documentation collection, preparation, and retention; visual inspections; and testing and verification methodologies for the performance of ventilation system components remain unchanged.

The ANSI/ASSP Z9.14-2020 revision subcommittee, chaired by Farhad Memarzadeh, National Institutes of Health, with Vice Chair Louis DiBerardinis, Massachusetts Institute of Technology, included experts who had experience using ANSI Z9.14-2014 and could identify gaps and provide lessons learned to incorporate into the revision. Representation included the following:

Affiliated Engineers: Krishnan Ramesh

ABSA International: John Henneman

National Institutes of Health, Division of Technical Resources: Nika Lilley

Sandia National Laboratories: Vibeke Halkjaer-Knudsen

SCB Compose: Sheri Bernstein

Tulane National Primate Research Center: Angela Birnbaum

Department of Agriculture/Agricultural Research Services: Joseph Kozlovac

Department of Agriculture/Animal and Plant Health Service: Kirk Martin

University of Alabama at Birmingham Southeastern Biosafety Laboratory: Julie Gibbs-Erwin

University of California, Irvine: Gary Landucci

The continued use of ANSI/ASSP Z9.14 as an approved testing methodology has provided a level of consistency in the industry that did not exist prior to the standard. The criteria in the standard may be supplemented, expanded, or consolidated as required by the specific testing and verification effort, the organization, and the regulatory and policy requirements specific to each facility. Use of ANSI/ASSP Z9.14-2020 may also encourage the development of additional standards that govern other aspects of high-containment laboratories.

In summary, ANSI/ASSP Z9.14-2020 is a voluntary technical standard containing methodologies for the testing and performance verification of ventilation and related systems required within a BSL-3/ABSL-3 facility. It remains the only standard of its kind.