Frameworks for
PROTECTING
WORKERS AND
THE PUBLIC
from Inhalation Hazards

Jonathan Samet, Autumn Downey, and Olivia C. Yost, Editors

Committee on Respiratory Protection for the Public and Workers
Without Respiratory Protection Programs at Their Workplaces

Board on Health Sciences Policy

Health and Medicine Division

A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS
Washington, DC
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This activity was supported by contracts between the National Academy of Sciences and the Centers for Disease Control and Prevention (Contract #200-2011-38807/75D30120F00086) and the Environmental Protection Agency (Contract # 68HERC19D0011/68HERC21F0115). The study received additional support from the CDC Foundation and the Department of State. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-27137-0
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Frameworks for protecting workers and the public from inhalation hazards. Washington, DC: The National Academies Press. https://doi.org/10.17226/26372.

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COMMITTEE ON RESPIRATORY PROTECTION FOR THE PUBLIC AND WORKERS WITHOUT RESPIRATORY PROTECTION PROGRAMS AT THEIR WORKPLACES

JONATHAN SAMET (Chair), Dean and Professor, Colorado School of Public Health

GLORIA ADDO-AYENSU, Director, Fairfax County Department of Health

WÄNDI BRUINE DE BRUIN, Provost Professor of Public Policy, Psychology, and Behavioral Science, University of Southern California

SARAH COEFIELD, Air Quality Specialist, Missoula City-County Health Department

HOWARD COHEN, Consultant, Professor Emeritus, University of New Haven

JOSEPH DOMITROVICH, Physiologist, National Technology and Development Program, United States Forest Service

KAREN EMMONS, Professor, Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health

SHAWN GIBBS, Dean and Professor, Texas A&M University School of Public Health

AYSE P. GURSES, Professor and Director, Armstrong Institute, Center for Health Care Human Factors, Johns Hopkins University

ROBERT HARRISON, Clinical Professor of Medicine, Division of Occupational & Environmental Medicine, University of California, San Francisco

STEPHANIE HOLM, Co-Director, Western States Pediatric Environmental Health Specialty Unit, University of California, San Francisco; and Public Health Medical Officer, Children’s Environmental Health Center, Office of Environmental Health Hazard Assessment, California EPA

SUNDARESAN JAYARAMAN, Professor, School of Materials Science and Engineering, Georgia Institute of Technology

JAMES JOHNSON, Consultant, JSJ and Associates

BRUCE LIPPY, President, The Lippy Group, LLC

DAVID MICHAELS, Professor, Environmental and Occupational Health, Milken Institute School of Public Health, The George Washington University

MARY RICE, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center

KEVIN RILEY, Director of Research and Evaluation, Labor Occupational Safety and Health Program, University of California, Los Angeles

DANIEL SHIPP, President (retired), International Safety Equipment Association

ROSEMARY SOKAS, Professor, Department of Human Science, Georgetown University School of Nursing and Health Studies; Professor, Department of Family Medicine, Georgetown University School of Medicine

JOHN VOLCKENS, Professor of Mechanical Engineering, Director, Center for Energy Development and Health, Colorado State University

Study Staff

AUTUMN DOWNEY, Study Director

OLIVIA C. YOST, Program Officer

AURELIA ATTAL-JUNCQUA, Associate Program Officer

CLAIRE GIAMMARIA, Associate Program Officer (until June 2021)

MICHAEL BERRIOS, Research Associate

LYDIA TEFERRA, Research Assistant

SCOTT WOLLEK, Senior Program Officer

ANDREW M. POPE, Senior Director, Board on Health Sciences Policy

Consultants

TODD AAGAARD, Charles Widger School of Law, Villanova University

JOHN BECKMAN, California Department of Public Health

RONA BRIERE, Briere Associates, Inc.

ERIN HAMMERS FORSTAG, Independent Science Writer

ARDEN ROWELL, University of Illinois College of Law

Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by ELI Y. ADASHI, Brown University, and DAVID L. EATON, University of Washington. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Preface

In November 2020, as the Committee on Respiratory Protection for the Public and Workers Without Respiratory Protection Programs at Their Workplaces held its first meeting, the COVID-19 pandemic was beginning a deadly surge, and the nation had just seen the end of one of its most severe wildfire seasons. A gap in providing respiratory protection for workers exposed to SARS-CoV-2 (the virus that causes COVID-19) was evident, and the number of workers needing an effective respiratory protective device was mounting as the exposure risks for essential workers became apparent. The public also sought effective respiratory protection and in some locales was mandated to do so, although there was uncertainty about what devices should be used, and misinformation concerning respiratory protection for the public circulated widely.

In addressing its charge, the committee understood the urgent context of its work and the need for change in the national approach to respiratory protection, both for workers and for the population at large. The committee’s approach to this study began with a broad assessment of what is known about respiratory protection for its two target populations—workers not covered by a workplace respiratory protection program and the public—and what systems are in place to provide such protection when needed. Summarizing a substantial body of material, the committee found that too many workers are left unprotected because of such failures as inadequate enforcement of existing Occupational Safety and Health Administration (OSHA) regulations, lack of relevant standards, and lack of OSHA coverage. The committee also found that the public has received little attention with respect to respiratory protection, with the exception of the major

pollutants regulated by the Environmental Protection Agency, particularly as regards airborne particulate matter, as well as wildfire smoke. The COVID-19 pandemic has brought attention to the critical role of aerosols (small infectious particles) in spreading the disease, but systems are generally lacking for guiding the population on what devices to use for protection against these airborne hazards.

In this report, the committee provides its approach to creating the frameworks needed to protect workers not covered by a respiratory protection program and the general population. The committee recognized that only a systems approach would remedy the failings and gaps it had identified. It also found that the needed frameworks could not be implemented without action at the highest levels of government, and that authorities need to be designated through agency, congressional, and White House actions if the nation is to provide respiratory protection equitably for the entire U.S. population.

The committee’s proposed frameworks and its associated recommendations constitute a template for action, detailing the steps that need to be taken. There are still choices to be made among the options for moving forward that are laid out in this report, and the committee details which of these options it believes are best supported whenever its findings provided a clear direction. Regardless, we are unified in urging that the proposed frameworks should be implemented without delay.

In addressing its complex charge, the committee gathered input from diverse sectors, including federal, state, local, and tribal public health; occupational safety and health; labor unions and other worker organizations; private-sector manufacturers; and federal regulatory agencies. We wish to express our gratitude to the many individuals who gave presentations and participated in discussions during our public meetings, as well as the reviewers whose constructive feedback on the draft of this report made for a much stronger final product.

The committee is particularly grateful to Arden Rowell, professor at the University of Illinois College of Law and consultant to the committee. Professor Rowell authored a remarkably comprehensive paper on the regulatory landscape for respiratory protection that guided us through the maze of regulations and laws relevant to our task. She also provided always thoughtful and timely reviews of the draft report. The committee would also like to recognize Todd Aagaard, professor at the Villanova University Charles Widger School of Law and consultant to the committee, for his review of and commentary on the regulatory landscape paper and input to the committee. We appreciate as well the assistance provided by John Beckman, BS, California Department of Public Health, with the analysis of OSHA citation data.

The committee is deeply grateful to the staff of the National Academies of Sciences, Engineering, and Medicine, led by Autumn Downey, senior program officer. The members of the staff team included Olivia C. Yost, Aurelia Attal-Juncqua, Claire Giammaria, Michael Berrios, Lydia Teferra, Scott Wollek, and Andrew Pope. We single out Autumn for bringing a deep understanding of our task and contributing invaluable insights as she kept the committee focused and on time, and she was always available at “crunch time” as we completed and revised the report. The team was ably supported by the skillful writing efforts of Erin Hammers Forstag and editing work of Rona Briere and Allison Boman.

Finally, as chair, I thank the committee for its engagement with completing our task. Of necessity, we were a diverse group with the needed wide breadth of expertise and experience. We learned from each other and made our way through challenging discussions as we resolved tough issues. Thank you for making my job as chair easy and fun.

We will all be watching and waiting for the next steps called for in our report. Taking them will benefit public health.

Jonathan Samet, Chair
Committee on Respiratory Protection for the Public and Workers
Without Respiratory Protection Programs at Their Workplaces

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Contents

ACRONYMS AND ABBREVIATIONS

GLOSSARY

ABSTRACT

SUMMARY

1 INTRODUCTION

Study Scope and Key Terminology

Study Context

Study Approach

Organization of the Report

Annex 1-1 Respiratory Protective Device Terminology

References

2 THE REGULATORY LANDSCAPE FOR RESPIRATORY PROTECTION

Use of Respiratory Protection in the Workplace

Respiratory Protection for the Public

Conformity Assessment of Respiratory Protection

Oversight of the Supply Chain for Respiratory Protective Devices

Overarching Conclusion

References

3 RESPIRATORY PROTECTION IN THE WORKPLACE

Unmet Respiratory Protection Needs in the Workplace

Systems for Ensuring Respiratory Protection in the Workplace

Beyond Respiratory Protection Program (RPP) Requirements in OSHA’s Respiratory Protection Standard

Specific Worker Groups

References

4 RESPIRATORY PROTECTION FOR THE PUBLIC

Needs of the Public for Respiratory Protection

Current Devices for the Public and Needs for Future Respiratory Protective Devices

Availability and Access Issues for Respiratory Protective Devices for the Public

Challenges and Limitations with the Public’s Use of Respiratory Protective Devices

Behavioral and Educational Considerations for Ensuring Effective Use of Respiratory Protective Devices by the Public

Stakeholder Roles in Community Engagement Around the Use of Respiratory Protection by the Public

Respiratory Protection Guidance Currently Available for the Public

Concluding Remarks

References

5 A GENERAL FRAMEWORK FOR RESPIRATORY PROTECTION OVERSIGHT AND GUIDANCE

A Systems Approach to Reducing Risks from Inhalation Hazards

A General Framework for Oversight and Guidance to Meet Respiratory Protection Needs

References

6 RESPIRATORY PROTECTION OVERSIGHT AND GUIDANCE FOR WORKERS

Ensuring Adequate Authorities to Protect Workers from Inhalation Hazards

Meeting Worker Needs: Application of the Committee’s Framework

Concluding Remarks

References

7 RESPIRATORY PROTECTION OVERSIGHT AND GUIDANCE FOR THE PUBLIC

Ensuring Adequate Coordination and Authorities to Protect the Public from Inhalation Hazards

Defining Responsibilities and Addressing Gaps in Authorities Related to the Framework Functions

References

APPENDIXES

A STUDY APPROACH AND METHODS

B REVIEW OF FACTORS NECESSARY TO ENSURE RESPIRATORY PROTECTION IS EFFECTIVE FOR ITS INTENDED USE

C COMMISSIONED PAPER: THE REGULATORY LANDSCAPE REGARDING RESPIRATORY PROTECTION

D BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS AND STAFF

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Boxes, Figures, and Tables

BOXES

S-1 Key Respiratory Protection Terminology Used in This Report

S-2 Core Functions of the Committee’s General Framework

1-1 Statement of Task

1-2 Overview of Respirator Types and Factors That Influence Their Selection

2-1 Respiratory Protection Program Requirements Under the Occupational Safety and Health Administration

2-2 State Regulations to Protect Workers from Wildfire Smoke

2-3 California’s Aerosol Transmissible Diseases Standard

2-4 Certification versus Approval

2-5 Overview of FDA Guidance on Filtering Facepiece Respirators for Use by the General Public in Public Health Medical Emergencies

2-6 Fit Capability Testing

3-1 Data Sources for Estimating the Scope of Unprotected Workers Exposed to Inhalation Hazards

3-2 OSHA Guidelines for Employers on SARS-CoV-2

3-3 Selected Examples of Guidance on Use of Respiratory Protective Devices for Workers

4-1 Questions the Public May Have About Respiratory Protective Devices

4-2 Counterfeit Respirators on the Market

4-3 Lessons Learned from a Respiratory Protection Distribution Program in Israel

4-4 Essential Questions for Effective Education and Communication

4-5 Importance of Risk Communication in Addressing the Public Use of Respiratory Protection: Lessons from Taiwan

4-6 The Importance of a Cohesive Strategy to Address Sociobehavioral and Logistical Barriers to Use of Respiratory Protection: Lessons from South Korea

4-7 Selected Examples of Federal Guidance on Public Use of Respiratory Protective Devices

5-1 Characteristics Essential to Success of the Coordinating Entity

7-1 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F0

7-2 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F1

7-3 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F2

7-4 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F3

7-5 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F4

7-6 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F5

7-7 Consolidated Roles for the Coordinating Entity Across Functions

FIGURES

S-1 Core functions in the committee’s framework for oversight and guidance for respiratory protection

1-1 Examples of respirators, medical masks, face coverings, and barrier face coverings

1-2 Comparison of particulate matter size fractions

1-3 Hierarchy of controls

1-4 A general risk-reduction paradigm for protection against inhaled agents

1-5 A system model depicting factors that influence the effectiveness of respiratory protective devices

2-1 PPE conformity assessment framework

2-2 NIOSH process for respirator approval

3-1 Potential failure points for workplace use of respiratory protection

3-2 OSHA requirements related to voluntary use of respirators

3-3 Summary of PM and carbon monoxide concentrations measured on wildland firefighters

3-4 Relative risk of lung cancer and cardiovascular disease associated with length of seasonal wildland firefighting work

3-5 Respiratory protection practices for health care workers exposed to airborne hazards

3-6 Evolution of health and safety risks across the phases of a disaster

5-1 Processes needed to deliver respiratory protection from design and manufacturing to use

5-2 Examples of evidence-based performance requirements for respiratory protective devices in the context of an influenza pandemic

5-3 Core functions in the framework for oversight and guidance for respiratory protection

5-4 Function F0: subfunctions related to ongoing development and approval of respiratory protective devices

5-5 Function F1: subfunctions related to assessing a hazard and determining the need for respiratory protection

5-6 Function F2: subfunctions related to determining the necessary respiratory protective devices

5-7 Function F3: subfunctions related to ensuring availability and access pathways for the respiratory protective devices

5-8 Function F4: subfunctions related to engaging, informing, and ensuring access for the target community via multiple stakeholders and pathways

7-1 A hub-and-spoke model for coordination related to respiratory protection for the public

7-2 Drivers and outcomes of a framework for the public

TABLES

S-1 Key Expertise, Resources, and Authorities of a Lead Oversight Agency, Organized by Framework Function

1-1 Matrix of Populations and Hazards for Consideration in Selecting Respiratory Protection Use Scenarios as Focus Areas for This Study

1-2 Burden of Respiratory Disease Due to Select Airborne Transmissible Biological Agents as of November 2021

Annex 1-1 Definitions and Descriptions of Respiratory Protective Devices from Federal and Other Sources

3-1 Comparison of Requirements for Mini and Full RPPs

3-2 Wildland Firefighters’ Job Tasks

3-3 Characteristics of Workers in Front-Line Industries

5-1 Ongoing and Event-Triggered Activities for Each of the Core Framework Functions

5-2 Fragmentation of Governmental Stakeholder Responsibilities and Authorities Based on the Hazard Type and Exposure Context

6-1 Recommended Actions for Stakeholders

7-1 Current Stakeholder Responsibilities and Authorities Related to Respiratory Protection for the Public

A-1 Articles Captured and Remaining After Screening for Relevance to the Review Topics

A-2 Frequency of OSHA Respiratory Protection Standard Citations by Industry Type

A-3 Frequency of OSHA Respiratory Protection Standard Citations by Gravity

A-4 Frequency of OSHA Respiratory Protection Standard Citations by Inspection Type

A-5 Summary Statistics on Penalties for OSHA Respiratory Protection Standard Citations

Acronyms and Abbreviations

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Glossary

A variety of terms are used to describe personal devices worn to reduce adverse health effects from inhalation hazards. Definitions and descriptions of these devices vary, and no one consistent definition is used by federal agencies and other authoritative stakeholders for such terms as respirator, face covering, and mask (see Annex 1-1 in Chapter 1 for a table of terminology used by federal agencies and others). This glossary is intended to provide general committee-generated definitions of key concepts and devices discussed in this report. Where definitions were taken from other sources, the source is noted in a footnote.

Assigned protection factor: The workplace level of respiratory protection that a respirator or class of respirators is expected to provide to employees when the employer implements a continuing, effective respiratory protection program as specified by section 29 CFR 1910.134.¹

Barrier face covering: A product that conforms to ASTM F3502-21 and that is worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and a degree of particulate filtration to reduce the amount of inhaled particulate matter.²

___________________

¹ OSHA (Occupational Safety and Health Administration). 2009. Assigned protection factors for the revised respiratory protection standard. OSHA 3352-02.

² ASTM International. 2021. ASTM F3502–21 standard specification for barrier face coverings. https://www.astm.org/Standards/F3502.htm (accessed October 5, 2021).

Conformity assessment (CA): Demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled.³

Dust mask: Also known as nuisance masks, these are non-approved devices that are worn to reduce exposure to airborne contaminants when working in dusty environments. They do not protect against toxic dusts and are not approved as respirators. Unlike medical or surgical masks, there are no standards that govern their construction or the quality of their filtration.

Face covering: A type of device that covers the nose and mouth but does not conform to any specific standard and does not provide a known degree of protection. The device may be constructed of single or multiple layers of cloth, filtering material, or a combination of base material and filter elements and may appear visually similar to barrier face coverings or surgical/medical masks.

Hazard: Anything (substance, situation, or behavior) that has the ability to cause an adverse outcome, including fatal or nonfatal injury or illness.

Inhalation hazard: Any type of gas, vapor, or particle, including airborne transmissible microorganisms (bacteria, viruses, molds), that can be breathed in and potentially cause harm.

Mask: With the notable exception of dust masks (defined above), these are devices worn by individuals that cover the nose and mouth and are designed and intended to reduce the spread of infectious agents found in large droplets such as from saliva, sneezes, and coughs.

Respirator: A device that is designed to protect the wearer from the adverse effects of inhalation hazards by removing contaminants from the surrounding air or by supplying clean air from a safe source.

Respiratory protection: Broadly describes any approach designed to reduce exposure to hazards that can be inhaled (i.e., inhalation hazards). Devices worn to provide respiratory protection can either protect the wearer or, for some hazards (e.g., airborne transmissible microorganisms), protect others from an infectious source. Some devices may provide some level of protection to both the wearer and to others.

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³ ISO (International Organization for Standardization). 2020. ISO/IEC 17000:2020 conformity assessment—vocabulary and general principles. https://www.iso.org/standard/73029.html (accessed October 5, 2021).

Respiratory protective device: Any personal device that provides protection against inhalation hazards when used effectively, acknowledging that each device may offer either personal protection or source control or both at varying levels. The blend of personal protection and source control is context specific (i.e., depends on both the device and the hazard in question).

Risk: The likelihood that a hazardous exposure will result in an adverse outcome.

Source control: An approach to eliminating or reducing the introduction of harmful substances into the environment. In the context of an infectious aerosol, devices worn by individuals that cover the nose and mouth may be used for source control to reduce the emission of harmful infectious agents from the wearer, thereby decreasing the potential danger to others in the immediate environment.

Surgical/medical mask: Unfitted devices generally regulated by the Food and Drug Administration for use in health care settings. They provide a physical barrier to fluids and particulate materials, and may provide some protection against contamination of the surrounding environment by their wearer by reducing the amount of infectious agents released during exhalation, coughing, or sneezing.

Susceptibility: An individual’s risk for harm when exposed to a particular hazard.

Vulnerability: An individual’s likelihood of being exposed to a hazard because of who they are; where they work, study, or play; or where they live.

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