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Applied Biosafety v21n3Applied Biosafety: Journal of ABSA International is a peer-reviewed scientific journal committed to promoting global biosafety awareness and best practices to prevent occupational exposures and adverse environmental impacts related to biohazardous releases.

A goal of Applied Biosafety is to provide a forum for exchange of sound biosafety and biosecurity initiatives through publication of original research, review articles, editorials, and special features.

We welcome and encourage submissions which further the profession of biosafety.

Anthology of Biosafety Series

The Anthology of Biosafety Series is, to date, a 14-book series that addresses biosafety in different settings.

I: Perspectives on Laboratory Design
II: Facility Design Considerations
III: Application of Principles
IV: Issues in Public Health
V: BSL-4 Laboratories
VI: Arthropod Borne Diseases
VII: Biosafety Level 3
VIII: Evolving Issues in Containment
IX: Exploring the Performance Envelope for BSL-3 and BSL-4 Laboratories
X: Animal Biosafety
XI: Worker Health and Safety Issues
XII: Managing Challenges for Safe Operations of BSL-3/ABSL-3 Facilities
XIII: Animal Production and Protection – Challenges, Risks, and Best Practices
XIV: Sustainability


Anthology of Biosafety I: Perspectives on Laboratory Design

Contents: Management of Biosafety – Design Issues at the Management/Facility Interface – Primary Biocontainment Devices – HVAC Issues in Secondary Biocontainment – Open BSL-2 Laboratories – Facility Guidelines for BSL-2 and BSL-3 Biological Laboratories – Design of BSL-3 Laboratories – Building a Maximum Containment Laboratory – Designing the BSL-4 Laboratory – Role of the Class III Cabinet in Achieving BSL-4 – Containment Design Concepts for Extraterrestrial Sample Return – Biosafety Considerations for Design of Large-Scale Facilities – Small Animal Research Facilities and Equipment – Small Animal Research Facility Management – Large Animal Research Facilities – Waste Management Considerations


Anthology of Biosafety II: Facility Design Considerations

Working Safely with Wild Poliovirus – Biocontainment of Highly Pathogenic Avian Influenza Contents: Viruses – Maximum Containment for Researchers Exposed to Biosafety Level 4 Agents – Modular/Mobile BSL-2/3 Laboratories – Facility Maintenance Operations (Skilled Trades) for Biological Containment Laboratories – Construction and Commissioning Guidelines for Biosafety Level 4 (BSL-4) Facilities – Safety and Health Considerations for Conducting Work with Biological Toxins – Primary Containment Devices for Toxicological Research and Chemical Process Laboratories – Toxicology Laboratories – Medical and Infectious Waste Management


Anthology of Biosafety III: Application of Principles

Contents: Risk Assessment for Working with Infectious Agents in the Biological Laboratory – Biosafety Considerations in rDNA: Viral Gene Transfer Vectors, DNA-based Vaccines and Xenotransplantation – Biological Safety and the Academic Environment – Biosafety Issues in Hospital Settings – An Overview: Biological Safety from a Global Perspective – Beyond Compliance: Global Biological Safety at Johnson & Johnson – Twenty Years of Global Biosafety Programs – Ergonomic Considerations in Biomedical Research Laboratories


Anthology of Biosafety IV: Issues in Public Health

Contents: Autopsy Biosafety – Emerging Infectious Diseases – Emergency Response Action Plan for Pathogens – Bioterrorism: Public Health Preparedness – Biological/Chemical Terrorism and the University – Establishing a European Network for the Diagnosis of “Imported” Viral Diseases (ENIVD) – Global Perspectives on Infectious Substance Transportation – Biosafety Needs in Laboratories in Developing Countries – Biosafety in Brazil: Past, Present, and Prospects for the Future – Understanding, Assessing, and Communicating Topics Related to Risk in Biomedical Research Facilities – Status of Schools of Public Health in Educating Public Health Laboratory Scientists – The Public Health Laboratory System—Is It Prepared? – Managing and Using Immunization and Medical Surveillance Data – Biosafety in Public Health Laboratories – Biological Safety and Public Health Laboratory Design – Design Issues for Insectaries – Bioterrorist Threats to the Food Supply – Emerging and Reemerging Bacterial Zoonotic Infections in Russia: Current Trends – Investigations of Emerging Zoonotic Diseases – Agricultural Pathogens, Biological Containment, and the Biological and Toxin Weapons Convention


Anthology of Biosafety V: BSL-4 Laboratories

Contents: The Evolution of Biosafety from the U.S. Biological Warfare Program (1941-1972) – Anthology of Some Biosafety Aspects in Russia (up to 1960) – Emerging and Reemerging Infectious Diseases: A Global Perspective – Emergence of Bacterial and Other Zoonoses: Why Always A Surprise? – Why Does Brazil Need a Biosafety Level 4 Facility? – Security Considerations for Microbiological and Biomedical Facilities – Polio Virus Laboratories – The Polio Facility at SSI in Denmark: GMP and Containment – A Comparison of Containment Facilities and Guidelines in Russia and the United States – Working at Biocontainment Level 4—Contain the Operator or Contain the Bug? – A Class III Cabinet BSL-4 Laboratory – BSL-4 Laboratory Guidelines – Class III Cabinet Line in Japan – Validation of a BSL-4 Laboratory – Medical Emergency Planning for BSL-4 Containment Facilities – Monitoring of Specific Contamination of Virology Laboratories During Work with Filoviruses – Performance Verification of Containment Level 4 Laboratories: The Canadian Approach – Design and Operation of a High-Containment Sewage Treatment Facility – Animal Experimentation in Level 4 Facilities – Animal Necropsy in Maximum Containment


Anthology of Biosafety VI: Arthropod Borne Diseases

Contents: Arthropod Vectors and Their Role in Transmitting Pathogens to Humans and Animals – Laboratory-acquired Infections – Biosafety Issues and Solutions for Working with Infected Mosquitoes – Working Safely with Recombinant Viruses and Vectors – Protect Yourself and Your Sample: Processing Arbovirus-infected Biting Midges for Viral Detection Assays and Differential Expression Studies – Isolation of Arboviruses from Field-collected Mosquitoes – Arthropod Containment Guidelines – Safe and Secure Handling of Virus-exposed Biting Midges Within a BSL-3-Ag Containment Facility – An Alkaline Hydrolysis Tissue Digestion System for a BSL-3-Ag Containment Facility – Organizing and Carrying Out Work with Animals Under Stationary Laboratory and Field Conditions – Biosafety Practices in Field Research: A Reviewed Experience – Collaborative Research on Crimean-Congo hemorrhagic fever virus at SRCVB “Vector”—Scientific and Biosafety Aspects


Anthology of Biosafety VII: Biosafety Level 3

Contents: Biosafety Level 3 Laboratory Design – Modular/ Mobile BSL-2/3+ Laboratories – BSL-3 Insectary Facilities – From Dioxin to Anthrax: A Laboratory Redesign – Formaldehyde Fumigation for BSL-3 Facilities – The Class III Biological Safety Cabinet – Comparative Pathology in Biosafety Level 3 Containment – Biocontainment in Developing Countries – Biosafety, Field Research, and Issues Related to Emerging Diseases in Brazil – Some Biosafety Considerations for Special Agents Using BSL-3 Facilities in Brazil – Procedures for Wild Poliovirus Containment at the Time of Global Certification of Polio Eradication – The Moment of Truth: Crisis Communication for Laboratories – Transport of Infectious Substances—The Development of New Regulations – Community Relations for High-Containment Laboratories: The Canadian Science Centre for Human and Animal Health Model – Treatment of Solid and Liquid Biowaste and ISO Registration of the Process – U.S. Laboratory Response Network and Its International Expansion


Anthology of Biosafety VIII: Evolving Issues in Containment

Contents: Toward Global Biosafety Harmonization – Emerging Challenges to Containment: Development of a Biodefense Infrastructure – Brazilian Experience in Implementation of Biosafety Level 3 Laboratories (BSL-3) – Design Considerations for Large-Scale Production of Biologicals: GMP and Containment Synergies – Animal Room Design Issues in High-Containment – Mobile/Modular Containment Facilities – Management of Multihazardous Wastes from High-Containment Laboratories – Viral Genetic Diversity Network (VGDN) in Brazil – Working Safely with the Transmissible Spongiform Encephalopathies


Anthology of Biosafety IX: Exploring the Performance Envelope for BSL-3 and BSL-4 Laboratories

Contents: Emerging Infections and Healthcare Settings – Biosafety: Emerging Issues and International Challenges – The BSL-4 Laboratory: Perspective Verses Reality – Design and Ongoing Operational Challenges for Building Automation Systems in a Containment Facility – Steam Effluent Decontamination System – Design Guidelines for Public Health Laboratory Facilities in Brazil – Developing a Unit to Care for Patients with Highly Communicable, Serious Infectious Diseases – The Nebraska Biocontainment Patient Care Unit – Technological Integration and Development of the Modern Mobile Laboratory – Certification Process of a Biosafety Level-3 Facility in Nebraska’s State Public Health Laboratory – Operation of a High-Containment Laboratory Using Select Agents – Managing Animals in Containment—A Director’s View – Modern Biological Safety Standards in Tuberculosis Diagnostic (Clinical) Laboratories – Biosafety Enclosures for Automated Laboratory Equipment – Performing Small Particle Research in New Environments with Robotic Applications – Aerobiology Containment Systems – Decontamination and Disinfection Validation of Viral Agents in an Industrial Environment – Operating a BSL-3 Facility Under GMPs – Challenges of GMP Requirements in Containment Design: What do the Regulations Say?


Anthology of Biosafety X: Animal Biosafety

Contents: Expectations of the USDA Animal Care Inspector in Barrier Facilities – Aerosol Infection of Small Animals—Safety Considerations – Medical Surveillance for Personnel Working with Animals – Transport of Infectious Materials – Animal Biosafety Level 3: Facility Design Considerations – Road Map to a Successful Program: How to Put It All Together – Animal Biosafety Level Determinations – ABSL-3 Caging – Public Communication and BSL-4 Labs: The UC Davis Experience – Safety in the Biomedical Laboratory – Biocontainment Recommendations for Animal Agricultural Pathogens – A Class III Cabinet BSL-4 Laboratory – Using Viral Vectors in Animal Research – Advanced Technologies in Animal Research – Managing Students and Other Academic Challenges in Animal Biocontainment Facilities – Meeting the Challenges of High-Containment Animal Care – Medical Management of Exposures to Biological Threat Agents – Transport of Animals – Navigating Through IACUC—IACUC and IACUC-IBC Overlaps: Jointly Sponsored Research and Peer Review of Hazardous Agent Use in Animals – BMBL: The New Edition – International Agriculture BSL-3/4 Facilities – Nonhuman Primate Husbandry and Procedures for ABSL-3 and ABSL-4 – Contract Staffing in Animal Biocontainment Facilities – IACUC Issues in Biocontainment Research


Anthology of Biosafety XI: Worker Health and Safety Issues

Contents: S.A.F.E.R. Together—Building a Multidisciplinary Biosafety Network – Serum Banking in Biomedical Research – Medical Countermeasures against Agents of Bioterrorism – Health and Safety During Public Health Responses and International Travel – Occupational Health Issues for Animal Care Workers – Laboratory Animal Allergy – Respirator Fit Testing—Does It Really Protect Me? – Overview of the Biosafety Risk Assessment Process – Bacterial and Fungal Infections among Diagnostic Laboratory Workers: Evaluating the Risks – Achieving a “Biosafety Culture” in Biomedical Laboratories – Biocontainment Training: Setting Minimal Training Standards for Personnel – Creating a Value-added Safety Culture – Biosafety in Research and Clinical Settings – Trends in Clinical Laboratory Design – Patient Facility Safety and Design – Biocontainment of Polio Vaccine Production and Laboratory Facilities – Core Issues in Retrofitting an Existing Facility – Communicating Effectively: The Key to Influencing Others


Anthology of Biosafety XII: Managing Challenges for Safe Operations of BSL-3/ABSL-3 Facilities

Contents: Strategies for Coping with Multiple Biological Safety Regulations in High- Containment Laboratories – Reports, Legislation, and the Policy Process: Biosecurity and the Select Agent Program – Biological Risk Assessment – Laboratory Emergencies and the Incident Command System: A Brief Introduction to Roles and Responsibilities – Laboratory Biosafety Competency Development for the BSL-2, -3, and -4 – Validation of Non-Traditional Containment Equipment – Joint Perspectives on Managing a High-Containment Facility: Principal Investigator and Biosafety Personnel – Training & Staff Management in the Midst of the 2009 A(H1N1) Influenza Virus Outbreak – Biosecurity Considerations for Containment Laboratories: Example of a Public University System – Laboratory Exposures to Botulinum Toxin: Review and Updates of Therapeutics for the Occupational Health Provider – An Innovative Approach to Controlling Waste Water in a Bio-Containment Laboratory – Energy Efficiency Considerations in BSL-3 and ABSL-3 Laboratories – Greening Biosafety Laboratories – Biocontainment Considerations for Agricultural Animal Species – Partnering with Communities for Biosafety’s Sake – Disaster Planning for Animal Biocontainment Facilities

The Anthology XII book has been reviewed by Veterinary Information Network, Inc. on the Veterinary Support Personnel Network website. VSPN and VIN Book Reviews are written by colleagues in veterinary medicine for our colleagues in veterinary medicine and all levels veterinary education. Some texts are available for purchase through the VIN store others will include the ISBN information on the book review.


Anthology of Biosafety XIII: Animal Production and Protection – Challenges, Risks, and Best Practices
Contents: Remarks by Under Secretary for Research, Education and Economics (REE) at the USDA ARS 1st International Biosafety and Biocontainment Symposium – Introduction to Biocontainment and Biosafety Concepts as They Relate to Research with Large Livestock and Wildlife Species – Defining Animal Biosafety Level 3 and 3 Ag – From the Field to the Laboratory in an Animal Disease Outbreak Situation – Working with Biosafety 3 Agents That Interface Across Human, Livestock, and Wildlife Boundaries – Controlling Laboratory Risk…in a Global Biotech Revolution – Commissioning the Biocontainment Lab: Paving the Way for Effective and Troublefree Operations – Liquid Effluent Decontamination Design and Operations – Carcass Disposal for Biocontainment Facilities – Working Safely with Rift Valley Fever Virus – The Anatomy of a Biosafety Audit Process: A Continuous Monitoring Model – Strategies for Communicating with the General Public About High-Containment Laboratories – International Challenges Related to Arthropod Containment – One Health: A Concept for the 21st Century


Anthology of Biosafety XIV: Sustainability
Contents: Thoughts on the Sustainability Challenge – Sustaining a Culture of Biosafety – The Basic Principles of Threat Assessment – Small, Medium, Large, Extra Large: Sustainable Biosafety & Biosecurity Solutions – Do Less, With Less. Get More: Navigating the Regulatory Landscape + Addressing Risk “Glocally” – A Sustainable BSL-3 Laboratory in a Platinum Leed® Building for Work with Tier 1 Select Agents – Healthier and More Engaged—Strategies for Sustaining a Thriving Workforce – Sustainability Is a Team Sport—Improving Worker Health Through Biosafety and Sustainability – Reducing Laboratory Energy Use with Demand-based Control – Biological Safety Cabinet Energy and Safety Considerations – Class II Biosafety Cabinet Sustainability – Green Autoclaves (Steam Sterilizers) – First Steps in Establishing Sustainability in an Animal Containment Environment – Safety, Sustainability, and Common Sense in the Vivarium: Mutually Exclusive Goals? – Sustainable Animal Facilities—Design and Operational Considerations – Challenges to Sustainability of Biosafety and Biosecurity Programs in Uganda: Analysis of National Laboratory Assessment, USAID STAR-EC Laboratory Rapid Needs Assessment and Laboratory Audit Reports – Sustainable Biosafety Communities

ANSI/ASSE Z9.14-2014 STANDARD
BACKGROUND MATERIALS

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).

Executive Summary

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:

CONTENTS
 FOREWORDiii
1EXECUTIVE SUMMARY1
2Purpose2
3Scope2
4Definitions3
5Applicability and Conformance11
      5.1 Applicability11
      5.2 Conformance12
      5.3 Verification of Conformance to Regulations13
6Overview13
      6.1 Ventilation-Testing Performance Categories13
      6.2 Generic Typical Sequence of Testing and Performance verification14
      6.3 Roles, Responsibilities, and Qualifications17
           6.3.1 Role/Responsibility as It Relates to a BSL-3/ABSL-3 Facility19
7Risk Assessment21
      7.1 Risk Assessment Overview for Work with Hazardous Agents/Materials21
8GuidelineS for Implementing Testing and Performance verification22
      8.1 Verification22
      8.2 Documentation23
           8.2.1 Required and Recommended Documentation24
           8.2.2 Evidence of Documentation24
           8.2.3 Ventilation-Testing Documentation Verification28
      8.3 Visual Inspection of Ventilation and Related Systems29
           8.3.1 Visual Inspection and Evaluation of Engineering Controls30
           8.3.2 Visual Inspection and Evaluation of Architectural Features32
           8.3.3 Visual Inspection of Directional Airflow34
           8.3.4 Visual Inspection of Exhaust Air System36
           8.3.5 Visual Inspection of Supply-Air System41
           8.3.6 Visual Inspection of Critical Control-System Air and Power47
           8.3.7 Primary Containment Equipment49
           8.3.8 Visual Inspection of High-Efficiency Particulate Air (HEPA ) Filters51
           8.3.9 Control Systems/Fail-Safe Operation54
           8.3.10 Visual Inspection: Special Considerations for ABSL-3 Facilities54
      8.4 Testing Ventilation and Associated Systems General Requirements55
           8.4.1 Testing for Directional Airflow during Normal Operation57
           8.4.2 Testing for Directional Airflow during System Failures61
           8.4.3 Testing of Anterooms68
           8.4.4 Testing of Primary Containment Equipment70
           8.4.5 Testing of Heating, Ventilating, and Air Conditioning (HVAC) System and Controls74
           8.4.6 Testing of Electrical Systems Related to Heating, Ventilating, and Air-Conditioning (HVAC)93
           8.4.7 Testing of High-Efficiency Particulate Air (HEPA) Filters98
           8.4.8 Testing of Ductwork and Room-Air Leakage104
           8.4.9 Testing of Specialized Heating, Ventilating, and Air-Conditioning (HVAC) Components of ABSL-3 Facilities108
           8.4.10 Testing of Heating, Ventilating, and Air-Conditioning (HVAC) Systems of Containment Support Areas112
 APPENDICES113
 Appendix A  Corrective Action Plan (CAP) and Template113
 Appendix B  Factors to consider in performing a Risk Assessment115
 Appendix C  Hazard Risk Matrix117
 Appendix D  How to Compile a Standard Operating Procedure (SOP)120
 Appendix E  Index of Acronyms121
 Appendix F  References123

Links and Additional Information

Additional examples of public and private sector recognition of this new standard:

University of California at Irvine:
http://som.uci.edu/bsl3-training/programs-under-development.asp

An article from 2011 in the AIHA publication “The Synergist”:
http://www.aihasynergist-digital.org/aihasynergist/201103?pg=14#pg14