ANSI/ASSE Z9.14-2014 STANDARD
Since the release of the release of the new Z9.14 Standard, there continues to be significant interest from SH&E professionals working with laboratory related hazards and exposures.
The ANSI/ASSE Z9.14 Standard focuses on performance verification of engineering controls related specifically to ventilation system features of BSL-3/ABSL-3 facilities, (Testing and Performance-Verification Methodologies for Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3). Z9.14 is the only guidance that provides a methodology to verify ventilation systems in such facilities. The standard provides 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.
ASSE is the secretariat of the ANSI/ASSE Z9 Ventilation Committee (Z9 ASC) and published the standard following extensive work and dedication from the Z9 Committee and the Z9.14 Subgroup and its leadership team. Without doubt this standard will play a critical role in moving laboratory ventilation forward and we are already seeing significant interest in the standard from both the public and private sector on the local, state, national, and global levels.
Over 1,000 BSL-3/ABSL-3 laboratories and animal facilities have been constructed in the United States. The design for their ventilation systems has been largely guided by the criteria defined in successive versions of Biosafety in Microbiological and Biomedical Laboratories (BMBL) from the Department of Health and Human Services (DHHS), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) (Biosafety in Microbiological and Biomedical Laboratories (BMBL) n.d.); the American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) standards; U.S. Department of Agriculture Animal Research Service (USDA ARS) 242.1 Manual; World Health Organization (WHO) Biosafety Guidelines: Biosafety Manual; and the National Institutes of Health Design Requirements Manual (DRM). Many of these guidelines offer design requirements, but lack the testing and performance-verification methodology to ensure the safe operation of the ventilation system for these laboratories.
Due to these inquiries for information about the standard we have put together what we call a "guide" for those with an interest. The following information below should hopefully be of assistance:
Status and Title: On January 24, 2014, the American National Standards Institute approved the new standard, "Testing and Performance Verification Methodologies for Ventilation Systems for BSL-3/ABSL-3 Facilities" (ANSI/ASSE Z9.14-2014).
Testing and verification of the ventilation system of laboratories that operate at Biosafety Level 3 (BSL-3)/Animal Biosafety Level 3 (ABSL-3) are necessary processes for ensuring that the performance and operation of the systems consistently maintain a safe environment for human occupants, research animals, and the internal and external environment. Because each facility is unique, testing and verification acceptance criteria will differ among facilities. Therefore, a risk-based approach to testing and verification of the ventilation system is recommended. It is highly encouraged that each facility develops and maintains standard operating procedures (SOPs) that address testing and verification of the ventilation system and associated components. Additionally, there should be SOPs for performing a risk assessment and for the sequence of testing and performance verification. Risk assessments should be performed initially and at regular periods throughout the life cycle of the facility.
ANSI Z9.14 provides recommendations for testing methodologies, guidance on the ventilation system components that should be inspected visually, and what is needed to verify that the system components operate such that the overall system's performance (i.e., directional inward airflow, response to failures, minimizing leakage, etc.) can be verified to ensure safe operation of the facility's ventilation system. A verification program needs to consider and compare federal, state, and local regulations for future use, best practices, and organizational requirements.
This standard provides the user with:
- Testing standardization, uniformity, and consistency through the use of minimal performance-based testing and verification methodologies for BSL-3/ABSL-3 ventilation systems
- Technical background and information that addresses the engineering and associated systems for ventilation within a BSL-3/ABSL-3 laboratory using the many tenants of a risk assessment and performance-based approach that is fully compatible with biorisk- management systems and national and international health and safety- management systems without duplicating or contradicting their requirements
- Risk assessment guidance and methodologies to identify hazards that can be evaluated in terms of the likelihood that a problem may occur and the damage from such an event that may occur.
- The collective knowledge of biosafety and design professionals and owners/operators who recognize the need to establish uniformity in the requirements and methodologies for the testing and performance verification of the ventilation system of BSL-3/ABSL-3 laboratories.
The criteria contained herein should be supplemented, expanded, or consolidated as required to adapt to the specific testing and verification effort, the organization, and the specific regulatory and policy requirements that may apply in each case. Suggested acceptance criteria, where available, are provided in the standard. Establishment of acceptance criteria is the responsibility of facility management.
Acceptance criteria should be based on site- specific risk assessment and performance objectives.
Table of Contents of the Approved Published Standard:
Applicability and Conformance
5.3 Verification of Conformance to Regulations
6.1 Ventilation-Testing Performance Categories
6.2 Generic Typical Sequence of Testing and Performance verification
6.3 Roles, Responsibilities, and Qualifications
6.3.1 Role/Responsibility as It Relates to a BSL-3/ABSL-3 Facility
7.1 Risk Assessment Overview for Work with Hazardous Agents/Materials
GuidelineS for Implementing Testing and Performance verification
8.2.1 Required and Recommended Documentation
8.2.2 Evidence of Documentation
8.2.3 Ventilation-Testing Documentation Verification
8.3 Visual Inspection of Ventilation and Related Systems
8.3.1 Visual Inspection and Evaluation of Engineering Controls
8.3.2 Visual Inspection and Evaluation of Architectural Features
8.3.3 Visual Inspection of Directional Airflow
8.3.4 Visual Inspection of Exhaust Air System
8.3.5 Visual Inspection of Supply-Air System
8.3.6 Visual Inspection of Critical Control-System Air and Power
8.3.7 Primary Containment Equipment
8.3.8 Visual Inspection of High-Efficiency Particulate Air (HEPA ) Filters
8.3.9 Control Systems/Fail-Safe Operation
8.3.10 Visual Inspection: Special Considerations for ABSL-3 Facilities
8.4 Testing Ventilation and Associated Systems General Requirements
8.4.1 Testing for Directional Airflow during Normal Operation
8.4.2 Testing for Directional Airflow during System Failures
8.4.3 Testing of Anterooms
8.4.4 Testing of Primary Containment Equipment
8.4.5 Testing of Heating, Ventilating, and Air Conditioning (HVAC) System and Controls
8.4.6 Testing of Electrical Systems Related to Heating, Ventilating, and Air-Conditioning (HVAC)
8.4.7 Testing of High-Efficiency Particulate Air (HEPA) Filters
8.4.8 Testing of Ductwork and Room-Air Leakage
8.4.9 Testing of Specialized Heating, Ventilating, and Air-Conditioning (HVAC) Components of ABSL-3 Facilities
8.4.10 Testing of Heating, Ventilating, and Air-Conditioning (HVAC) Systems of Containment Support Areas
Appendix A Corrective Action Plan (CAP) and Template
Appendix B Factors to consider in performing a Risk Assessment
Appendix C Hazard Risk Matrix
Appendix D How to Compile a Standard Operating Procedure (SOP)
Appendix E Index of Acronyms
Appendix F References
Links and Additional Information
- ASSE Info on Standards Development Process
- Official Memorandum of Understanding Between OSHA & ANSI
- Office of Management & Budget Circular OMB-A119
- Position Statement on Consensus Standards(PDF 28KB)
- Safeguarding: Are ANSI Standards Really Voluntary?
- What's the Difference Between an OSHA Rule and an ANSI Standard?
Additional examples of public and private sector recognition of this new standard:
University of California at Irvine:
An article from 2011 in the AIHA publication "The Synergist":