Appendix C

The Regulatory Landscape Regarding Respiratory Protection¹

by Professor Arden Rowell, J.D.

Commissioned by the National Academies Committee on Respiratory Protection for the Public and Workers Without Respiratory Protection Programs at Their Workplaces

CONTENTS

Executive Summary

Introduction

Part I: The Existing Regulatory Landscape

A. Respiratory Protection in the Workplace

1. Occupational Use and Regulation in the Workplace

a. The Occupational Safety and Health Administration (OSHA)

i. The general authority of OSHA under the OSH Act

ii. Limitations on OSHA’s authority under the OSH Act

(1) Limitations on the types of workplaces and hazards OSHA regulates

(2) Informational requirements that OSHA must meet prior to regulating

iii. OSHA’s current approach to respiratory protection

(1) The Respiratory Protection Standard and RPPs

(2) OSHA regulations and guidance addressing respiratory hazards at workplaces without RPPs (including voluntary programs at OSHA)

b. Other authorities under the OSH Act 15

i. The National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC)

ii. National Advisory Committee on Occupational Safety and Health (NACOSH)

c. Other federal agencies

i. The Environmental Protection Agency (EPA)

(1) EPA’s general structure and authority

(2) EPA’s past coordination with OSHA

(a) Coordination through overlap with OSHA: The example of the pesticide Worker Protection Standard (WPS)

(b) Coordination across gaps: The example of workplace asbestos regulation

ii. The Mine Safety and Health Administration (MSHA)

d. States and local authorities

i. Federal preemption and state law

ii. State Plans and federal/state coordination

iii. Other areas of state authority, including state and local government workers

e. Characterizing occupational use472

i. Workers for whom OSHA has chosen not to create an RPP

ii. Workers protected by an authority other than OSHA

iii. Gap workers: Workers without any apparent statutory protection

2. Occupational Oversight

a. The National Institute for Occupational Safety and Health (NIOSH)

i. The general authority of NIOSH under the OSH Act regarding development, approval, marketing, and postmarket surveillance

ii. The Respiratory Health Division (RHD), a division of NIOSH

iii. The National Personal Protective Technology Laboratory (NPPTL), a division of NIOSH

(1) History and structure of NPPTL

(2) Role and activities of NPPTL

(3) NPPTL’s respirator certification testing

(4) NPPTL’s work and approach in the pandemic

b. Other authorities

i. Federal agencies

ii. State and local authorities

c. Stockpiling

d. Characterizing occupational oversight regarding development, approval, marketing, and postmarket surveillance

B. Respiratory Protection for the Public

1. Nonoccupational Use

a. The Environmental Protection Agency (EPA)

i. The Clean Air Act

(1) EPA’s general authority under the Clean Air Act

(2) Criteria air pollutants

(3) Regulation of hazardous air pollutants (HAPs)

(4) EPA’s practice regarding the regulation of inhalation hazards from air pollution

(5) Characterizing EPA’s approach under the Clean Air Act

ii. The Toxic Substances Control Act (TSCA)

(1) EPA’s authority under TSCA

(2) Exceptions to TSCA and overlaps with other federal authority

(3) Other statutes administered by EPA

(4) Characterizing EPA’s approach under TSCA

b. The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS)

i. CDC’s statutory authority regarding inhalation hazards and public health

(1) CDC’s role in public respiratory protection

(2) Role of agencies within CDC

(a) The National Institute for Occupational Safety and Health (NIOSH)

(b) The National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry (NCEH/ATSDR)

c. The Federal Emergency Management Agency (FEMA)

d. Other authorities

i. Other federal authorities

ii. State and local authorities

(1) Proactive regulatory regimes

(2) Liability regimes

e. Characterizing nonoccupational use

2. Nonoccupational Oversight

a. Food and Drug Administration (FDA) within HHS

i. The general authority of FDA under the FD&C Act regarding use of respiratory protection by the public

ii. FDA regulation of respirators

iii. Characterizing FDA’s approach

b. The Consumer Product Safety Commission (CPSC)

c. The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC)

d. Other authorities

i. Federal authorities

ii. State and local authorities

iii. Foreign authorities

e. Characterizing nonoccupational oversight

Part II: Potential Recommendations and Their Impacts on the Regulatory Landscape

A. Identifying Key Actors and Actions

Chart 1: A Summary of Institutional Actors—Authority, Key Strengths, and Sample Forms of Action

B. Making Recommendations to Congress

1. Features and Limitations of Congressional Action

2. Potential Types of Recommendations

C. Making Recommendations to the President

1. Features and Limitations of Executive Action

2. Potential Types of Recommendations

D. Making Recommendations to Agencies

1. Features and Limitations of Agency Action

2. Potential Types of Recommendations

Conclusion

EXECUTIVE SUMMARY

The regulatory landscape of respiratory protection in the United States is highly fragmented, involving multiple actors at the federal and subfederal levels, which have varying responsibilities and have authority regarding different aspects of different respiratory hazards.

Occupational Protection

A few regulatory authorities—notably the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH)—have substantial authority over the regulation of health and safety of many workplaces and over respiratory protection of workers in those workplaces. Many other authorities, including the Environmental Protection Agency (EPA), have authority over inhalation hazards in specific workplaces or against specific hazards.

• Most workers are not currently protected by a respiratory protection program (RPP) or by mandatory workplace safety standards addressing the use of respiratory protection. OSHA has the statutory authority to implement new or expanded RPPs if they find that the respiratory hazards workers are facing are a “significant risk,” and so long as the workers are not part of a statutorily excepted group (e.g., state and local government workers or the self-employed).
• NIOSH, and its division the National Personal Protective Technology Laboratory (NPPTL), is the primary federal authority for researching and certifying respiratory protection for the workplace. While some other federal and state actors are involved in oversight for some workers in some industries or as against some hazards, these recommendations tend to be coordinated with NIOSH, and with NPPTL, which plays a critical role in centralizing evaluation of occupational respiratory protection. NIOSH also provides guidance for workers outside its programs, and in some cases has acted historically as a consultant on matters of respiratory oversight that touch on its expertise. That said, NIOSH’s mandate, authority, and consequent testing protocols are directed toward workplace respiratory protection rather than toward more general public protection.

Protection of the Public

The regulation of respiratory protection for the public is more fragmented than occupational respiratory protection. There is no central authority responsible for respiratory protection of the public, and there is not even any centralized repository of information about which authorities are responsible for which hazards.

• There is no single federal entity responsible for regulating the use of respiratory protection by the public, though there are a number of federal agencies responsible for regulating specific types of respiratory hazards that might require or be addressed by respiratory protection. Among these agencies, EPA and the Centers for Disease Control and Prevention (CDC) have the broadest mandates, with the Federal

• Emergency Management Administration having special authority in the context of emergencies.
• There is no single federal entity responsible for overseeing the development, approval, marketing, or postmarketing surveillance of respiratory protection for the public, or for generating or overseeing a certification program for managing these processes. The Food and Drug Administration serves an oversight function for respiratory protection used for “medical purposes,” and several other federal entities serve some oversight function against specific respiratory hazards. In the gap left by the lack of centralized federal authority, multiple agencies have issued nonbinding guidance to advise the public regarding respiratory protection. This guidance often relies upon oversight and certification provided by NIOSH for occupational contexts.

Regulatory Implications of Recommendations by the Committee

Recommendations for addressing the gaps and overlaps created by this complex regulatory landscape can be most effective when they are addressed to the institutional actor(s)—whether congress, the president, or agencies—with the authority to respond. As a general matter, the committee may be able to maximize the effectiveness of its recommendations by making specific (and in some cases differing) types of recommendations to congress, the president, and agencies. In particular, this may involve making recommendations specifically to agencies to address gaps and overlaps that come from regulatory interpretations, to congress to address any statutory gaps and/or matters of appropriations, and to the president to address problems of coordination and enforcement.

INTRODUCTION

The National Academies Committee on Respiratory Protection for the Public and Workers Without Respiratory Protection Programs at Their Workplaces (“the Committee”) has commissioned a background paper as part of the context for its study and to inform its recommendations. This document is the final draft of that background paper.

The Committee presented the following tasks to be addressed by the background paper:

1. Describe the regulatory environment, including applicable laws, regulations, and guidance documents related to use of respiratory protection in occupational and nonoccupational settings and regarding oversight of the development, approval, marketing, and post-market surveillance of respiratory protection; and
2. Analyze the implications of new or revised laws or regulations that may be considered to address current gaps in responsibilities and authorities related to respiratory protection for the public and workers without workplace respiratory protection programs.

Accordingly, this paper (1) describes the existing regulatory landscape regarding respiratory protection, and (2) analyzes the potential regulatory landscape that might exist in response to recommendations by the Committee. In addition, the Committee has asked that the paper identify key authorities related to national stockpiling of respiratory protective gear.

To answer these questions, the paper splits into two parts, with each part designed to answer one of the presented questions. Part I addresses the existing regulatory landscape regarding the use and oversight of respiratory protections for workers and the public. It begins by addressing the relatively centralized landscape regarding respiratory protection in the workplace (including a brief treatment of stockpiling), before then addressing the more fragmented regulatory landscape of respiratory protection for the public. Part II addresses the options and implications of potential Committee recommendations, including recommendations to Congress, agencies, and the President. It also includes a brief overview into the types of laws and regulations that make up the regulatory landscape of respiratory protection.

The goal of this paper is to provide the Committee with factual information about the regulatory landscape regarding respiratory hazards. The paper does not recommend or advocate for any particular course of action. Rather, it is intended to help the Committee as it navigates through a complex and often fragmented landscape, which involves multiple actors at the federal and subfederal levels, which have varying responsibilities and have authority regarding different aspects of different respiratory hazards. Thus, while the paper identifies important legal and regulatory implications that flow from making one kind of recommendation over another, it leaves the Committee to chart its own way through those recommendations. In this sense, the paper is meant to be a cartographic document that the Committee can use to help plan its journey from where we are now to where the Committee believes we should be in the future.

While this paper aims to provide the Committee with a meaningful map of the regulatory landscape regarding respiratory hazards, the landscape is too fragmented and the time scale for research is too short to have either found or included every detail regarding the regulation of respiratory protection. The paper has prioritized general topographic takeaways and characterizations over specific program descriptions or lists—and as the Committee will see, even this choice has generated a very long paper. The hope is that the outlines of the landscape will still prove helpful to the Committee as it develops recommendations to improve the respiratory protection both of workers without respiratory protection programs and of the general public. It should also provide a starting point for further research, including research to be undertaken by the National Academies staff, where such inquiries are deemed valuable.

PART I: THE EXISTING REGULATORY LANDSCAPE

This part of the paper describes the existing regulatory landscape regarding the use and oversight of respiratory protections. It provides an overview of the multiple legal actors and authorities that bear on how respiratory protection is used and overseen for both occupational and nonoccupational use. Existing authorities substantially distinguish between occupational and nonoccupational regulation of respiratory protection, so the paper addresses those categories separately.

As it discusses the various authorities and legal constraints on occupational and nonoccupational respiratory protection, this part seeks to identify where there are clear areas of authority, and at which agencies, so that the Committee can make its eventual technical, scientific, and medical recommendations directly to those authorities. It also identifies where there are potential problems of “overlap,” where multiple actors have authority, and “gaps,” where arguably no actors have authority. As is discussed further in Part II, distinguishing these situations may be helpful in informing the Committee’s eventual recommendations and in tailoring those recommendations in light of the underlying regulatory structure.

As a brief preview of the substance of this part, of the two contexts, the regulation of respiratory protection for occupational use is significantly more centralized—and less fragmented—than regulation of respiratory protection outside the workplace. This means that there are clearer authorities to which recommendations may be directed regarding the regulation of occupational respiratory protection than regarding the regulation of respiratory protection for the public.

A. Respiratory Protection in the Workplace

This section describes the existing regulatory landscape regarding respiratory protection in the workplace. It begins by describing the way that occupational respirator use is regulated, and then proceeds to a discussion of the regulatory oversight of respiratory protection (including development, approval, marketing, and postmarketing surveillance). The Committee has also requested that the paper include, where possible, a treatment of the authority to stockpile respiratory protective devices. To that end, this section also includes a brief treatment of the authorities involved in stockpiling respiratory protective devices for the public.

There is no single federal statute, executive plan, or agency that addresses respiratory protection in all workplaces as against all inhalation hazards. That said, two federal agencies—the Occupational Safety and Health Administration (OSHA), which is responsible for setting enforceable workplace safety standards, and the National Institute for Occupational Safety and Health (NIOSH), which is responsible for research, certification, and other forms of nonenforceable oversight—share primary authority for protecting most workplaces in the nation against most respiratory hazards.

The remainder of this section details the roles of OSHA and NIOSH, as well as the roles of other federal agencies that have authority that overlaps with, or in some cases displaces, the authority of OSHA and/or NIOSH. As a general matter, the section concludes that OSHA and NIOSH have significant federal authority regarding respiratory protection in the workplace, though the protection they offer is not comprehensive. OSHA regulates respiratory protection in the workplace primarily through requirements for respiratory protection programs (RPPs), which apply in circumstances where OSHA has determined that respiratory hazards present a substantial risk to workers.²

Most workplaces are unprotected by such plans.³ Furthermore, the Occupational Safety and Health Act (OSH Act) limits OSHA’s authority over significant categories of workers, including the self-employed, many state and local government workers, and workers who are imperiled by hazards outside OSHA’s primary authority.⁴ While these instances of overlapping authority between OSHA and other agencies add complexity to the regulatory landscape of occupational respiratory protection use, that complexity is addressed at least in part by a statutory provision that displaces OSHA authority where other agencies have regulated, and by the history of coordination between OSHA and other agencies regarding respiratory protection standards. Despite this coordination, some workers—including the self-employed—remain unprotected from respiratory hazards by any federal or state authority.⁵

Although it is not empowered to issue enforceable workplace safety standards, NIOSH plays an important role in researching respiratory protection standards and in certifying respirators for occupational use through the National Personal Protective Technology Laboratory (NPPTL).⁶ While some other actors are involved in oversight for some workers in some industries or as against some hazards, these recommendations tend to be coordinated with NIOSH, and with NPPTL, which plays a critical role in centralizing evaluation of occupational respiratory protection. NIOSH also provides guidance for workers outside its programs and in some cases has acted historically as a consultant on matters of respiratory oversight that touch on its expertise; as a result, NIOSH’s expertise sometimes influences the management of inhalation hazards to the public. That said, NIOSH’s mandate, authority, and consequent testing protocols are directed toward workplace respiratory protection rather than toward more general public protection.

1. Occupational Use and Regulation in the Workplace

This section addresses current agency authority to regulate use of respiratory protection in the workplace. The general purposes of the section are to provide both a general overview of the regulatory landscape regarding occupational use of respiratory protection and to help the Committee in distinguishing where recommendations can be addressed effectively to OSHA from situations where recommendations on occupational use of respiratory protection would need to address other authorities as well.

Although respirators were certified for occupational use in the United States as early as 1920 by the Bureau of Mines,⁷ the use of respirators in workplaces was not federally regulated in the United States until 1969, with the passage of the Federal Coal Mine Health and Safety Act.⁸ Amendments to that act created the Mine Safety and Health Administration (MSHA) and empowered it to set enforceable workplace standards in mines while simultaneously continuing the certification and oversight work of the Bureau of Mines.⁹ The following year, Congress passed the OSH Act of 1970 to address workplace safety in (most) other workplaces.¹⁰ In the OSH Act, however, Congress chose to bifurcate enforcement and research responsibilities, creating and empowering OSHA to issue and enforce enforceable safety standards,¹¹ and NIOSH for research, certification, and other oversight functions.¹² The OSH Act also called for establishment of the National Advisory Committee on Occupational Safety and Health (NACOSH), which serves an advisory role.¹³

Because of this allocation of authority, OSHA is the primary federal authority for issuing enforceable standards regarding respiratory hazards and the use of respiratory protection in the

workplace. The first portion of this section is therefore dedicated toward more fully describing the authority of OSHA, outlining the extent of OSHA’s authority, and flagging where are there gaps where OSHA is precluded from regulating (e.g., in regards to state and local government workers). The section then expands on the federal, state, and local authorities that have authority over regulating respirator use in some workplaces, as against some hazards, and in some circumstances where OSHA’s authority is limited.

a. The Occupational Safety and Health Administration (OSHA)

OSHA is the preeminent government authority for regulating workplace safety and health.¹⁴ This subsection describes OSHA’s general authority and its current approach to regulating the use of respiratory protection, and highlights where OSHA’s existing approach is demanded by statute and where it appears to be a matter of agency discretion (that might be changed via a change in agency practice).

The subsection concludes that, while it has broad authority to set occupational safety and health standards for workers covered by the OSH Act, OSHA’s authority is limited in several circumstances, including where the statute excepts classes of workers from OSHA regulation (as with state and local workers and the self-employed) and where other agencies have issued such standards pursuant to their own statutory authority; OSHA’s authority is also limited by its own determinations about which workers are subject to substantial risk.

i. The general authority of OSHA under the OSH Act

OSHA derives its authority over workplace health and safety from the OSH Act, which was enacted “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources.”¹⁵ Under the OSH Act, employers have a general duty to furnish to their employees “employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to [their] employees.”¹⁶ The Act gives OSHA broad general authority in creating and enforcing “occupational safety and health standards,”¹⁷ which it defines as “standards which require conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment.”¹⁸ When dealing with “toxic materials or harmful physical agents,” OSHA is required to “set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.”¹⁹

Generally speaking, to promulgate an occupational safety and health standard, OSHA must go through notice-and-comment rulemaking and issue permanent standards.²⁰ That said, under the OSH Act, OSHA also has the rarely used authority to issue an Emergency Temporary

Standard (ETS) without notice and comment.²¹ An ETS remains in effect for 6 months, and when published, serves as a proposed permanent standard.²² An ETS must be directed toward a “grave danger” that can be protected against by the standard.²³ Courts have interpreted this to mean a life-threatening hazard that exists during the 6-month period the ETS is in effect.²⁴

Any employer under the OSH Act is required to comply with the occupational safety and health standards promulgated by OSHA.²⁵ The Act covers most private sector employers and their workers, both in the 50 states and in territories and jurisdictions under federal authority.²⁶ As discussed below, however, the Act does not cover many other workers. Occupational safety and health standards can, and do, address inhalation hazards in the workplace²⁷—though these standards are constrained by important limitations on OSHA’s authority under the OSH Act.

ii. Limitations on OSHA’s authority under the OSH Act

While OSHA has broad general authority in the regulation of workplace safety and health, its authority is constrained in important ways. Two types of constraints on OSHA’s authority are particularly worth noting: limitations on the types of workplaces and hazards OSHA may regulate; and informational requirements that OSHA must meet prior to regulating.

(1) Limitations on the types of workplaces and hazards OSHA regulates

The first of these constraints flows from the fact that the OSH Act exempts several important categories of workplaces and hazards.

Under the OSH Act, a workplace is only protected if it is managed by a person or entity that qualifies as an “employer” under the Act, and that can therefore be obligated to satisfy occupational safety and health standards.²⁸ The definition of who qualifies as an employer thus plays an important role in determining which workers and workplaces are protected with OSHA’s occupational safety and health standards, including respiratory standards.

The OSH Act defines an “employer” as “a person engaged in a business affecting commerce who has employees,” excepting that this “does not include the United States (not

including the United States Postal Service) or any State or political subdivision of a State.”²⁹ Under the explicit statutory language, Congress has clearly excluded federal, state, and local government workplaces (other than the Postal Service) from regulation by OSHA.³⁰ Other categories of potential covered employers are more ambiguous, however,³¹ depending at least partially on the definition of who constitutes an “employee.”

Unfortunately, the statutory definition of “employee” is similarly circular: under the statute, an “employee” is a person who is “an employee of an employer who is employed in a business of his employer which affects commerce.”³² This definition leaves substantial ambiguity over which workers qualify as employees, and thus which workers are subject to workplace protections by OSHA.

Generally speaking, agencies have substantial discretion in deciding how to interpret ambiguous terms in statutes they administer (as OSHA does with the OSH Act).³³ OSHA has long adopted a somewhat narrow interpretation of the OSH Act that determines whether a worker qualifies as an “employee”—and thus whether occupational safety and health standards apply—at least in part by reference to the (notoriously complex) system of judicial precedent that makes up the common law of agency.³⁴ To determine whether or not a worker is an employee or a self-employed “independent contractor” under common law, the hiring party is required to consider a number of factors, including the degree of control the hiring party asserts over the manner in which the work is done, and the degree of skill and independent judgment the hired party is expected to apply.³⁵ Because this test is multifactorial and fact-specific, it can be difficult to determine for many workers whether they are employees who qualify for protection under the OSH Act standards, or whether they are instead self-employed or independent contractors who

are not protected by the Act.³⁶ OSHA has adopted somewhat narrow interpretations of the Act, however, which exclude unpaid volunteers, family members of farm employees, and domestic workers in a residential setting,³⁷ as well as the general category of the self-employed.³⁸

Finally, the statute provides a third category of important exemptions from OSHA jurisdiction where occupational safety and health have been regulated by another federal agency. More specifically, § 4(b)(1) of the OSH Act excepts any context where other federal agencies “exercise statutory authority to prescribe or enforce standards or regulations affecting occupational safety or health.”³⁹ The purpose of this exception, which is articulated in § 4(b)(1) of the OSH Act, was to avoid wasteful duplication, such as might result where both OSHA and another federal agency are providing for the occupational safety of a class of workers.⁴⁰ While Congress could have managed such overlap in regulatory authority by preferencing OSHA’s workplace safety standards, it instead chose to preference standards set by other agencies, when they are acting within their statutory authority, and when they have actually acted to regulate some workplace hazard under that authority.⁴¹

As a result, OSHA’s authority to enforce occupational safety and health standards is sometimes limited by the actions of other agencies.⁴² This includes activities and conditions regulated under the control of another dedicated federal agency, such as the conditions in “coal and other mines,”⁴³ as well as where other agencies are authorized to regulate particular hazards, as with occupational inhalation hazards from pesticides.⁴⁴ Although less obviously relevant in respiratory protection contexts, OSHA’s authority is similarly limited over vessels regulated by

the Coast Guard,⁴⁵ contractor-operated nuclear facilities,⁴⁶ and large segments of the railroad and airline industries.⁴⁷ Except in specific circumstances, as discussed further below, OSHA standards regarding respiratory protection do not apply in these contexts. OSHA manages these and other occupational health and safety relationships via a complex mosaic of interagency cooperation agreements, or memoranda of understanding.⁴⁸

(2) Informational requirements that OSHA must meet prior to regulating

A second limitation on OSHA’s authority to regulate workplace safety arises from the long-standing regulatory interpretation that holds that OSHA is only authorized to promulgate health and safety standards in the workplace after it has satisfied a threshold finding that “a significant risk” of material health impairment exists. This requirement flows from the plurality opinion in an influential Supreme Court case, Industrial Union Department v. American Petroleum Institute (generally called the “Benzene decision”), which overturned a workplace safety standard under the OSH Act on the grounds that the agency had failed to determine that benzene posed what the plurality of the Supreme Court called a “significant risk” in the workplace.⁴⁹ The plurality opinion is controversial among legal commentators,⁵⁰ who note both that the requirement of significant risk is not mentioned in the statute itself and that other portions of the OSH Act demand repeatedly that OSHA regulate to ensure that “no employee will suffer diminished health, functional capacity, or life expectancy as a result of his work experience.”⁵¹ Nevertheless, the opinion has given rise to a long-standing agency practice at OSHA of demanding substantial information about the significance of a risk prior to issuing new workplace safety standards.⁵² Because this is a long-standing agency practice, recommendations by the Committee to OSHA regarding respiratory protection would likely need to account for the agency’s understanding of the significant risk requirement, and OSHA’s current approach to regulating respiratory protection may be best understood in light of it.

iii. OSHA’s current approach to respiratory protection

This subsection discusses OSHA’s existing approach to regulating the use of respiratory protection in the workplace. As it emphasizes, OSHA’s existing approach to regulating workplace respiratory protection is dominated by a sharply bifurcated level of protection for different workplaces, depending upon whether OSHA has found that its Respiratory Protection Standard requires the workplace to have a respiratory protection program (RPP) or not. Workers at workplaces with RPPs are provided with substantial levels of respiratory protection: they must be provided with employer-provided respirators and are further protected with a series of checks to ensure that those respirators fit and remain functional. Employers at workplaces without RPPs, by contrast, need not provide respiratory protection. Counterintuitively, in some cases, workers in workplaces without RPPs may not even be permitted to provide their own respirators for use at the workplace (in cases where the wearing of respirators is determined by the employer to be a hazard). The result is stringent regulation of respiratory protection in the workplace for workers in workplaces with RPPs, and voluntary or even limited use of respiratory protection in workplaces without RPPs.

(1) The Respiratory Protection Standard and RPPs

Generally speaking, OSHA’s primary approach to regulating the use of respiratory protection in the workplace is set out in its Respiratory Protection Standard,⁵³ a regulation that OSHA promulgated in 1998.⁵⁴ Under the Respiratory Protection Standard, employers must establish and implement an RPP “[i]n any workplace where respirators are necessary to protect the health of the employee.”⁵⁵ When it issued its final standard in 1998, OSHA estimated that the rule would mandate respiratory protection for approximately 5 million workers.⁵⁶ If this estimate is still accurate, and given that the Bureau of Labor Statistics estimates that there are 148 million employed persons in the United States,⁵⁷ this suggests that approximately 3.3 percent of American workers are protected with RPPs under OSHA’s Respiratory Protection Standard.

RPPs are highly specified, and workers in workplaces with an RPP must be provided with a NIOSH-certified respirator by the employer, as well as fit testing, medical evaluation, training, and ongoing recordkeeping.⁵⁸ Employers must provide respirators “which are applicable and suitable for the purpose intended,”⁵⁹ which involves using the NIOSH-certified respirator that is suited to the inhalation hazard presented.⁶⁰ Further specification of this complex set of requirements has been provided by National Academies staff. In general, the point for current purposes is that workers who are protected by RPPs are guaranteed significant protection that

extends from the designation of the underlying product to be used through to requirements about fit testing and ongoing recordkeeping.

(2) OSHA regulations and guidance addressing respiratory hazards at workplaces without RPPs (including voluntary programs at OSHA)

This section identifies and describes OSHA’s approach to regulating the safety of workers without existing RPPs. As a basic matter, at workplaces where OSHA does not regulate, or where it has not found respirators to be “necessary to protect the health of the employee,” no RPP is required.⁶¹ The Respiratory Protection Standard does allow for voluntary provision and use of respiratory protection in these workplaces⁶²—though the standard imposes limitations on that voluntary use. First, before any employee may use respirators (whether self-provided or voluntarily provided by the employer),⁶³ the employer must determine that respirator use “will not in itself create a hazard.”⁶⁴ If the employer finds that the respirator use is not a hazard, the employer is required to provide the employee with guidance developed by OSHA, “Information for Employees Using Respirators When Not Required Under the Standard.”⁶⁵ Finally, the employer must “establish and implement those elements of a written respiratory protection program necessary to ensure that any employee using a respirator voluntarily is medically able to use that respirator, and that the respirator is cleaned, stored, and maintained so that its use does not present a health hazard to the user.”⁶⁶ Workers in workplaces where the employer has determined that respirator use would create a hazard are therefore precluded from wearing respirators even voluntarily.⁶⁷ Where no hazard is presented by the respirator, workers can follow the guidance provided by OSHA in its “Information for Employees Using Respirators When Not Required Under the Standard.”⁶⁸ This information, also drafted in 1998, is about one page long—a significant contrast to the detailed requirements that apply under RPPs. This brief guidance encourages employees to use respirators even below exposure limits, while taking

actions (such as only using one’s own respirator) to prevent respirators from becoming a hazard themselves.⁶⁹

b. Other authorities under the OSH Act

The OSH Act of 1970 remains the primary statutory authority for regulation of workplace safety. As discussed above, under the OSH Act, OSHA is responsible for issuing enforceable workplace safety standards. As a result, it is the federal authority with the greatest responsibility for regulating the use of respiratory protection against respiratory hazards in the workplace. That said, the OSH Act also created and empowered two other authorities—NIOSH and NACOSH—which routinely coordinate with OSHA. Of these, NIOSH’s role in researching and recommending workplace safety standards is particularly important, while NACOSH acts as a relatively minor advisory committee that nevertheless has the authority to advise OSHA regarding its workplace safety standards.

i. The National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC)

NIOSH was created alongside OSHA in the OSH Act of 1970.⁷⁰ The primary statute empowering NIOSH for purposes of workplace use of respiratory protection remains the OSH Act, which allocates significant research authority to NIOSH, even as it tasks OSHA with standard setting and implementation.⁷¹ While NIOSH does not directly regulate any use requirements for respiratory protection in the workplace,⁷² as part of its research role, it is empowered to “develop and establish recommended occupational safety and health standards” on the basis of its research and analysis, which OSHA then has the authority to implement.⁷³ NIOSH also plays a critical role in oversight of the development and approval of respiratory protective gear in occupational settings, as described in Part I.A.2.

In developing and issuing recommendations, the director of NIOSH is authorized to “conduct research and experimental programs” that he or she “determines are necessary for the development of criteria for new and improved occupational safety and health standards,” and “after consideration of the results of such research and experimental programs make recommendations concerning new or improved occupational safety and health standards.”⁷⁴ Research performed by NIOSH, or by divisions of NIOSH (such as NPPTL), can thus generate and support recommendations to OSHA regarding enforceable workplace safety standards, including the regulation of respirator use in the workplace.

Perhaps unsurprisingly given their concurrent creation in the same statute, OSHA and NIOSH have a long history of coordinating their activities.⁷⁵

ii. National Advisory Committee on Occupational Safety and Health (NACOSH)

NACOSH serves an advisory role to the secretary of labor and the secretary of health and human services on matters related to administration of the OSH Act.⁷⁶ NACOSH is a 12-member body composed of representatives of management, labor, occupational safety and occupational health professions, and the public.⁷⁷ All support for NACOSH is provided by OSHA, and NACOSH submits reports and advice via OSHA.⁷⁸

While NACOSH does not have either rulemaking or enforcement authority of its own, it provides input on workplace safety and health issues, and feedback on existing initiatives under the OSH Act to improve worker safety and health.⁷⁹ Periodically, NACOSH identifies subcommittees and work groups dedicated to particular issues.⁸⁰

Most of NACOSH’s past recommendations have been relatively minor—for example, recommending that OSHA and other agencies fund a symposium⁸¹ or supporting OSHA’s existing attempts at rulemaking.⁸² Nevertheless, because it is a permanent, nondiscretionary advisory committee, with a close advisory connection to OSHA, NACOSH provides a durable

institutional locus for potential recommendations regarding the use of respiratory protection in the workplace.

c. Other federal agencies

This section provides a description of actors other than those empowered by the OSH Act that have the authority to regulate respiratory protection use in at least some workplaces, as against at least some hazards.

While OSHA has the primary authority to regulate workplace safety, the structure of the OSH Act—which prohibits OSHA from issuing workplace safety standards in any workplace where another federal agency creates or enforces workplace safety and health standards⁸³—makes the regulatory landscape of actual protection complex. As a result of this statutory structure, many federal agencies have authority to issue workplace safety standards in some workplaces against some hazards or in some circumstances, and these displace OSHA standards.

The displacement of OSHA standards by occupational safety and health standards set by another agency generally arises in one of two ways.

The first is through federal agencies’ general responsibility to regulate the safety of their own workplaces. Recall that federal agencies have the responsibility of managing their own occupational safety and health standards for their own workplaces.⁸⁴ These must generally meet the same standards as private employers.⁸⁵ Many agencies coordinate with OSHA and NIOSH for such standards, including regarding respiratory protection for their workers.⁸⁶

The second way OSHA standards are displaced is via the issuance of federal occupational safety and health standards by an agency other than OSHA, regarding a hazard or workplace over which that agency has statutory authority.⁸⁷ Recall here that the OSH Act provides that agencies displace OSHA standards when they prescribe or enforce standards or regulations affecting occupational safety or health against hazards under their jurisdiction.⁸⁸ Whether or not particular occupational safety or health standards displace OSHA standards in any particular situation, as against any particular hazard, in any particular workplace, is a surprisingly opaque question, and is often litigated.⁸⁹ The resulting mosaic of occupational safety and health regulations is difficult, if not impossible, to describe in its entirety.

Nevertheless, agencies other than OSHA have authority to regulate respiratory protection outside their own workplaces at least some of the time. These include agencies—such as the Environmental Protection Agency (EPA)—that have authority to regulate against some inhalation hazards in ways that may require regulation of respirator use in the workplace, and agencies that have authority to regulate particular workplaces or types of workplaces other than

their own, like MSHA. These two examples are discussed in more detail below. Notably, no other agency has OSHA’s broad rulemaking authority or its broad mandate regarding multiple hazards in workplaces across multiple industries. That said, in some cases, other agencies’ authority to regulate respiratory protection in the workplace extends over workers who would otherwise be unprotected by OSHA, such as state and local government workers.⁹⁰ In other cases, where other agencies have specific statutory authority to issue workplace safety and health standards—whether regarding specific hazards, specific workplaces, or under specific conditions—that authority displaces OSHA’s under the OSH Act⁹¹—though OSHA may still be permitted and even required to regulate other hazards.

i. The Environmental Protection Agency (EPA)

EPA has substantial authority to regulate a number of environmental inhalation hazards, some of which arise in workplaces. When EPA issues occupational safety and health standards under its statutory authority, these standards displace OSHA protections that would otherwise apply.

This section addresses the authority of EPA regarding regulation of workplace inhalation hazards and the use of respiratory protection. It describes the general authority of EPA, gives a brief summary of its most important statutory mandates, and explains EPA’s responsibilities regarding workplace exposures to respiratory hazards, emphasizing its history of coordination with OSHA/NIOSH regarding those exposures.

(1) EPA’s general structure and authority

EPA is the nation’s chief environmental agency. Created originally in 1970 via executive action, EPA administers a broad array of environmental statutes, including many that address exposure to pollutants and dangerous substances.⁹² As discussed further in the subsequent section addressing respiratory risks to the public, these include the Clean Air Act⁹³ and the Toxic Substances Control Act (TSCA),⁹⁴ as well as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),⁹⁵ the Emergency Planning and Community Right-to-Know Act (EPCRA),⁹⁶ the Resource Conservation and Recovery Act (RCRA),⁹⁷ and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).⁹⁸ None of these statutes restrict EPA to only regulating environmental exposures that are occupational. However, because some

exposures to dangerous substances arise in occupational settings, EPA sometimes ends up addressing worker safety, including as against some inhalation hazards.⁹⁹

(2) EPA’s past coordination with OSHA

This section identifies the substance and past practice of jurisdictional overlaps between EPA and OSHA and gives examples of how these overlaps have been managed in the past to harmonize across agencies and to help fill what could otherwise have become gaps in the regulatory landscape.

Generally speaking, the regulation of environmental hazards in occupational contexts presents an area of regulatory overlap between OSHA/NIOSH and EPA: where there are occupational exposures to environmental hazards, as with asbestos or pesticides, either or both agencies may have the authority to regulate, depending upon the particular hazard being protected against and the particular statutory grant of authority for both agencies.¹⁰⁰

In light of these frequent overlaps, OSHA/NIOSH and EPA have developed a long history of cross-agency coordination.¹⁰¹ In some cases, as in the FIFRA example provided below, this coordination has helped to reduce the complexity that can otherwise arise from competing and overlapping regulations of the same workplace. In other cases, as with the asbestos example below, it has been used to fill in gaps where OSHA, working alone, would not have been able to fully regulate workplace safety.¹⁰²

(a) Coordination through overlap with OSHA: The example of the pesticide Worker ProtectionStandard (WPS)

The regulation of respiratory protection against pesticides presents one example where coordination between EPA and OSHA helped to reduce regulatory complexity without reducing protection. Under FIFRA, EPA is authorized to regulate not just pesticides in general, but also specifically the exposures of pesticide handlers and farmworkers in the field.¹⁰³ Because the OSH Act prohibits OSHA from regulating working conditions or hazards when other federal agencies exercise statutory authority to issue occupational safety and health standards,¹⁰⁴ EPA’s authority displaces OSHA’s for this set of workplace hazards.

EPA’s Office of Pesticide Programs implements its pesticide programs.¹⁰⁵ Occupational safety standards implemented under FIFRA include the pesticide applicator certification program,¹⁰⁶ as well as the Agricultural WPS¹⁰⁷ that satisfies EPA’s statutory obligation to protect agricultural workers from pesticides.

The WPS protects 2 million agricultural workers and pesticide handlers.¹⁰⁸ With a few exceptions,¹⁰⁹ it requires employers to provide personal protective equipment (PPE), including respiratory protection.¹¹⁰ For some years, the fact that EPA was responsible for farmworkers and pesticide handlers in the field, while OSHA retained authority in some indoor environments and over farmworkers when exposed to hazards other than pesticides, created a challenge of coordination between the agencies. This was particularly true while the safety standards differed significantly. In part in response to these concerns, EPA revised its WPS in 2015 to coordinate its respirator safety standards with OSHA’s, adopting a set of requirements in the WPS that mirror those that attach to a workplace with an OSHA-implemented RPP.¹¹¹ Accordingly, as with workers with RPPs in place, farmworkers must be provided with adequate respiratory protection by their employers, who must also provide fit testing, training, and medical evaluation.¹¹² By incorporating OSHA standards in this way, EPA simplified a situation of overlapping authority that otherwise could have created significant additional complexity without improving levels of protection.

(b) Coordination across gaps: The example of workplace asbestos regulation

In some cases, the fact that EPA and OSHA are both empowered to regulate at least some workplace inhalation hazards has allowed the agencies to coordinate and thus to overcome gaps in regulatory protection for workers. The best example of this may be the coordination between EPA and OSHA/NIOSH on the regulation of asbestos in the workplace.¹¹³

In the case of asbestos, OSHA is authorized to set workplace safety standards under the OSH Act,¹¹⁴ whereas EPA’s authority arises under the Toxic Substances Control Act (TSCA),

which grants EPA broad authority to regulate toxic substances.¹¹⁵ As noted above, the OSH Act exempts state and local government workers, meaning that OSHA alone cannot create or enforce workplace safety standards that address state and local government workers—even if OSHA believes those workers to be at substantial risk from inhalation hazards.¹¹⁶ To address this gap, since 1985, EPA has used its authority under TSCA to protect state and local government workers engaged in asbestos abatement activities.¹¹⁷ This includes implementing a requirement for an RPP.¹¹⁸ To eliminate the chance of duplication, EPA has harmonized its regulation with OSHA by cross-referencing them, thereby requiring state and local employers to comply with OSHA’s asbestos regulations (and with any changes to those regulations that OSHA subsequently promulgates).¹¹⁹ Coordination in this case serves as an example of agency cooperation in overcoming statutory gaps to provide respiratory protection from (at least some) workplace inhalation hazards.

ii. The Mine Safety and Health Administration (MSHA)

Other agencies have statutory authority that displaces OSHA in regards to particular workplaces, and the inhalation hazards presented at those workplaces. The chief example of this type is MSHA, the successor to the Bureau of Mines, whose responsibilities regarding respirator safety actually pre-date the OSH Act.¹²⁰ The primary statute empowering MSHA is the Federal Mine Safety and Health Act, which requires MSHA to establish mandatory health and safety standards for “coal and other mines.”¹²¹

The purpose of the Act was to create a comprehensive regulatory scheme for preventing mine accidents and diseases caused by the occupation of mining.¹²² To this end, the statute directs MSHA to set standards that are structurally quite similar to those set by OSHA—“to set standards which will most adequately assure on the basis of the best available evidence that no miner will suffer material impairment of health or functional capacity even if such miner has regular exposure to the hazards dealt with by such standard for the period of his working life”¹²³—but again, specifically for mines.

Unlike the OSH Act, which separates standard-setting and research-based functions between OSHA and NIOSH, MSHA is empowered by the Federal Mine Safety and Health Act

for both developing and certifying respirators, and for enforcing safety standards.¹²⁴ MSHA thus has broad authority to regulate both use and oversight of respiratory protection, though this broad authority applies to the relatively limited set of workplaces that is made up of mines.

d. States and local authorities

Although this background paper focuses on the federal regulatory landscape, it is important to recognize that respiratory protection can also be affected by state and local law and authorities. Accordingly, this subsection provides an overview of the relationship between federal and state authority regarding workplace safety regulation, focusing on the regulation of use of respiratory protection in the workplace. As a general matter, it emphasizes that while the relationship between state and federal authority over workplace regulation is complex and still evolving, much of the time, federal standards preempt state standards on workplace safety. That said, the OSH Act establishes a complex system of “cooperative federalism” that leaves significant space for states to participate in governing workplace safety pursuant to federal constraints. As a result, many states administer their own occupational safety and health programs via OSHA-approved State Plans. State and local authorities also retain substantial authority over the regulation of several types of workplaces, including state and local government workplaces.

i. Federal preemption and state law

The relationship between state and federal workplace protections is complex. Congress is generally understood to have the authority to prevent states from regulating in areas where the federal government is empowered to act.¹²⁵ The principle that federal law overrides state law—often thought to derive from the Supremacy Clause of the U.S. Constitution—is known as preemption.¹²⁶ Conflicts between federal and state authority generate complexity in multiple areas of law.¹²⁷ That said, the law of preemption is particularly complex in areas of traditional state concern—including public health and safety—where the Supreme Court has adopted a general presumption against preemption that requires Congress to make its intent to supersede state law “clear and manifest.”¹²⁸ It is further complicated where—as with workplace

regulation—the historical evolution of an issue involves an interweaving of federal and state action, expertise, and jurisdiction.¹²⁹

Although complex, it is still possible to identify the general structure of authority as it is shared between federal regulators and state authorities. The OSH Act itself makes certain aspects of state authority relatively clear. Most notably, it declares that “nothing in this chapter shall prevent any State agency or court from asserting jurisdiction under State law over any occupational safety or health issue with respect to which no [federal] standard is in effect.”¹³⁰ This provision preserves state authority in areas that have not been regulated by OSHA or that the OSH Act does not reach—though it is worth noting that the provision has also been interpreted by the Supreme Court to implicitly preempt state regulation where OSHA has promulgated standards.¹³¹ This means that states are permitted to regulate regarding occupational safety and health where OSHA has not acted, but precluded from such regulation where OSHA is deemed to have issued a standard. Debate often surrounds the question of whether OSHA has regulated in a particular area of workplace safety or not.¹³²

ii. State Plans and federal/state coordination

In some cases, debate over whether OSHA has regulated in a particular area of workplace safety or not is addressed via interactions between OSHA and state agencies. The OSH Act somewhat famously establishes a form of “cooperative federalism,” a type of relationship between federal and state regulation where the federal government has the authority to regulate directly, but where it nevertheless chooses to leave states the option to regulate themselves—so long as they do so according to baseline federal standards.¹³³ In the context of OSHA, this structure is administered through the creation and approval of State Plans—OSHA-approved workplace safety and health programs, which are then operated by individual states or U.S.

territories, even as they implement OSHA safety standards.¹³⁴ OSHA limits its activities (such as site inspections) within states with approved State Plans and provides as much as 50 percent of the funding for administering those plans.¹³⁵

To have its plan approved by OSHA, a state must meet several requirements. It must designate a state agency responsible for occupational safety and health, ensure that state inspectors can enter workplaces, provide adequate staff, and cover employees of the state and its subdivisions.¹³⁶ Furthermore, it must show that its standards are “at least as effective” as OSHA standards in protecting workers and in preventing work-related injuries, illnesses, and deaths.¹³⁷ Although states are precluded from implementing standards that are less effective than OSHA standards, they can request approval to go beyond what OSHA standards require to mandate even more stringent protections.¹³⁸ OSHA has significant discretion in granting or denying such requests.

iii. Other areas of state authority, including state and local government workers

The existence of (or lack thereof) a State Plan has special relevance for whether state and local government workers are protected by RPPs or an equivalent. The OSH Act explicitly exempts state and local government workers from OSHA standards,¹³⁹ so state and local government workers are not automatically covered by RPPs or other OSHA standards.¹⁴⁰ In places with State Plans, workers—including state and local government workers—have protections at least as effective as OSHA standards regarding respiratory hazards in the workplace.¹⁴¹ There are currently 22 approved State Plans covering private and public state and local government workers, and 6 State Plans covering only state and local workers.¹⁴² Third--

party analysis of Census data suggests that there are 3.1 million state and local government workers in states without State Plans.¹⁴³ These workers are not covered either by OSHA standards or by OSHA-approved State Plans.

Finally, for workers or workplaces that the OSH Act does not reach or that OSHA has not regulated, as well as a few areas of state law that have been explicitly preserved, such as state workers’ compensation laws,¹⁴⁴ state law has a more direct impact. For example, California’s occupational safety and health agency—Cal/OSHA—recently issued updated guidance for employers on respiratory protection in the workplace that appear to go beyond OSHA requirements in several respects.¹⁴⁵ During the COVID-19 pandemic, some state agencies have also provided updated guidance to workers on the type of respiratory protection needed for specific workplaces.¹⁴⁶

e. Characterizing occupational use

This section summarizes the regulatory landscape regarding occupational use of respiratory protection, focusing particularly on the protection of workers who are currently not addressed by RPPs. It focuses on distinguishing the categories of workers who are not protected by RPPs, and on identifying the reason those categories are unprotected.

Specifically, workers who are currently not protected by RPPs fall into three categories: (1) workers who OSHA is responsible for protecting, but for whom OSHA has chosen not to create an RPP; (2) workers who OSHA is not responsible for protecting, but who some other authority is responsible for protecting; (3) “gap workers,” who no one is responsible for protecting. The regulatory landscape for each category is importantly different, in ways that may inform Committee recommendations. Where possible, this section identifies the source of any gap, overlap, or miscoordination, so that the Committee’s eventual recommendations can be tailored to the legal basis underlying those challenges, and to the legal authority that can best remedy any problem. Potential recommendations are identified merely for illustration purposes and are not meant to advocate for any particular prescription or recommendation.

i. Workers for whom OSHA has chosen not to create an RPP

Many workers who are subject to protection by OSHA are not protected by an RPP.¹⁴⁷ Potential protection of these workers varies according to the level of respiratory risk to which OSHA believes the workers are exposed at the workplace.

Some workers may be subject to significant respiratory risk in the workplace, despite their lack of current protection. For these workers, OSHA has the option of issuing a new RPP following its accustomed procedure, as outlined above. If the Committee believes that some worker types are exposed to significant risk in the workplace, for example as a result of the COVID-19 pandemic, and that these significant risks were not reflected in the protection offered by current RPPs, it could recommend issuance of RPPs by OSHA to other workers and/or other industries. For workers exposed to significant risk, whether protected by RPPs or not, OSHA also has the statutory authority to extend additional or alternative protections, other than those currently outlined in the RPP process, by issuing new regulatory rules or by amending existing rules.

As noted above, the RPP process is outlined by OSHA’s Respiratory Protection Standard.¹⁴⁸ OSHA has the discretion to revisit this standard if it believes that a different standard would satisfy its statutory obligations. If the Committee believes that OSHA’s current policy in addressing respiratory risk for workers facing significant risk is insufficient, it could recommend that OSHA change its policy by issuing an amended Respiratory Protection Standard. OSHA also has the authority to issue emergency rules more quickly under its ETS procedure.¹⁴⁹ Such a mechanism might be used to address immediate (and/or temporary) substantial respiratory risks to workers, such as those presented by the COVID-19 pandemic, who are otherwise covered under the OSH Act.

Other workers who are subject to protection by OSHA may not be protected by mandatory OSHA programs because they are not subject to what OSHA would consider to be significant risk. Creating mandatory standards to protect workers it believes are not at significant risk would require OSHA to revisit its long-standing interpretation of the Benzene decision, which it generally understands to mandate a finding of significant risk prior to issuing workplace standards. While OSHA may have the legal authority to reconsider its interpretation, this would be a substantial change in agency policy. Even absent changes in its interpretation of Benzene, however, OSHA has expansive authority to issue or amend existing voluntary guidance regarding respiratory protection.

ii. Workers protected by an authority other than OSHA

As noted above, the OSH Act exempts many workers from OSHA protection. Some of these workers are protected by other authorities, including other federal agencies. State and local authorities are specifically responsible for protecting state and local government workers, and while some states have adopted State Plans, others have not.

To address the protection level of workers who are unprotected by RPPs, but who are protected by health and safety standards set by other federal or state authorities, the Committee would have to address authorities other than, or in addition to, OSHA.

Workers in federal agencies and state and local government workers in states with State Plans have very similar levels of protection to OSHA-covered workplaces, as do farmworkers under EPA’s Worker Protection Standard (WPS) and state and local asbestos mitigation workers under EPA’s TSCA rule. Standards in these workplaces have been purposefully harmonized with OSHA’s requirements. While some of these rules have been harmonized via cross-referencing, however, as with EPA’s asbestos rule, it is not clear that all such programs have utilized cross-referencing. In some cases, these authorities might need to take additional action to realign their policies and standards with OSHA’s, particularly if OSHA were to update its Respiratory Protection Standard or its interpretation of when there are risks in the workplace significant enough to justify an RPP. As a result, if the Committee were to recommend that OSHA expand its RPP programs, either permanently or during the coronavirus emergency, it might be reasonable to also note for federal agencies, states with State Plans, and other agencies (such as EPA) that have harmonized with OSHA’s regulations that the Committee is recommending expansion of the respiratory protections offered in the workplace.

If the Committee believed that employers in states without State Plans should provide additional respiratory protection to their workers, consistent with the types of protections otherwise provided under RPPs, it should make that recommendation to states. States have the authority either to then propose a State Plan to OSHA, or to increase their existing respiratory protections for their own workers. OSHA has significant discretion in deciding to approve or deny requests for approval for more stringent state protection, about which the Committee could advise. OSHA could also presumably issue a policy statement or other guidance encouraging more stringent state-level regulation of otherwise unprotected workers.

iii. Gap workers: Workers without any apparent statutory protection

Some workers appear to fall into gaps, such that there is no clear authority responsible for regulating their occupational respiratory protection. These include self-employed persons (including independent contractors),¹⁵⁰ unpaid volunteers,¹⁵¹ family members of farm employees,¹⁵² and domestic workers in a residential setting.¹⁵³ These categories of workers are

exempted under OSHA’s current interpretation of the OSH Act and do not appear to be protected by occupational safety and health standards issued by any other authority.

The situation regarding each of these categories of unprotected workers is complex. As a general matter, to protect workers who are explicitly exempted from OSHA protection under the language of the OSH Act, a new act of Congress would be necessary. Even then, Congress might face constitutional hurdles, depending upon the category of workers to whom they sought to extend statutory protection. If Congress attempted to regulate state and local government workers currently exempted by the OSH Act, for example, it might face challenges under the Tenth Amendment,¹⁵⁴ while if it sought to protect (entirely) unpaid volunteers under the OSH Act, it might face challenges under the Commerce Clause.¹⁵⁵

Absent congressional action, OSHA clearly does not have the authority to extend protections to workers who are explicitly excluded by the statute, such as state and local government workers. OSHA, like Congress, is also constitutionally barred from regulating workers or workplaces that fall outside of the far boundaries of federal constitutional authority.

Some unpaid volunteers—those whose work falls outside of and does not affect interstate commerce—may fall into this category.

There are other categories of currently unprotected workers, however, who OSHA likely has the authority to protect even without an act of Congress. Where a statute is ambiguous, courts generally grant the agency that administers the statute broad discretion in choosing how to interpret the ambiguous term.¹⁵⁶ Agencies are even free to change their interpretations of the same term over time, and—so long as the agency’s interpretation is reasonable—even to adopt different interpretations of the term than those that courts would adopt.¹⁵⁷ Because of their circularity, the definitions of both “employer” and “employee” in the OSH Act are notably ambiguous, affording OSHA substantial discretion in deciding who qualifies for protection under the Act.¹⁵⁸ In some cases, OSHA appears to have used this discretion to adopt a narrow interpretation that excludes some workers from protection. For example, OSHA’s decision to exclude domestic workers from protection appears to be a product of its own interpretive choices; the OSH Act itself is silent regarding the status of domestic workers.¹⁵⁹ OSHA has also long excluded self-employed persons from the requirements of the Act,¹⁶⁰ apparently choosing to presume that self-employed persons are not “employers” because they have no “employees,” rather than treating self-employed persons as employers of themselves. The statute itself does not explicitly mandate this interpretation. Theoretically, this may mean that the Committee could recommend that OSHA reconsider its exclusion of workers who fall outside its current interpretation of “employee,” or that OSHA adopt the broadest interpretation of “employee” and/or “employer” permissible under the OSH Act.¹⁶¹ However, the agency may feel itself to be bound to its existing interpretations, either because it believes them to be wisest, or because of settled expectations. In that case, if the Committee believes that respiratory protection of these workers should be regulated by OSHA or another authority, it would need to address either Congress (to amend the statute, as below) and/or the President (to direct reinterpretation of the statute). The Committee could also direct recommendations to OSHA that fall short of recommending reinterpretation of the statute on this critical issue and that instead urge OSHA to issue improved or alternative guidance for workers who do not qualify as “employees” under OSHA’s interpretation.

Finally, if the Committee believed that the multiplicity of workplace safety standards was overly complex or counterproductive, or that additional worker types should be incorporated into the statute, it could recommend to Congress that it amend the OSH Act. For example, the Committee could recommend that Congress reconsider the provision of the OSH Act that prohibits OSHA from passing workplace health and safety standards when authority to do so has been granted to another agency.¹⁶² As further discussed in Part II, such amendments are time-consuming and unusual, as they require Congress to go through the process of legislation. Absent such a change, however, workplace respiratory standards may continue to be regulated by a patchwork of federal and state authorities, with OSHA standards playing a focal but not dominant role.

2. Occupational Oversight

This section identifies who has the authority to oversee development, approval, marketing, and postmarket surveillance of respiratory protection in the workplace. It focuses primarily on the regulatory role of NIOSH, though it will also discuss other authorities with more limited roles, including the Food and Drug Administration (FDA) and MSHA.

a. The National Institute for Occupational Safety and Health (NIOSH)

NIOSH is part of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS).¹⁶³

NIOSH has substantial responsibilities regarding occupational respiratory protection, though these responsibilities are driven by its role as a research and advisory institution. The section addresses the extent of NIOSH’s authority and describes NIOSH’s existing approach to oversight of respiratory protection. It also highlights the important role played by the National Personal Protective Technology Laboratory (NPPTL) within NIOSH in researching, evaluating, and certifying respirators.

i. The general authority of NIOSH under the OSH Act regarding development, approval, marketing, and postmarket surveillance

NIOSH was created under the OSH Act of 1970, which grants NIOSH the authority to “develop and establish recommended occupational safety and health hazards.”¹⁶⁴ Such recommendations are made to OSHA, which then has the authority under the OSH Act to implement and enforce them. In furtherance of its research and advisory role, NIOSH is directed to engage in research, develop plans, establish criteria, promulgate regulations, and conduct educational programs about the use of occupational safety and health equipment.¹⁶⁵

Because of its general statutory responsibility to research and recommend occupational safety and health standards, NIOSH is the primary authority for researching the effectiveness of respirators and other protective devices. Under this authority, NIOSH has established an approval process for respiratory protective devices, which it promulgated as a rule on

“Respiratory Protective Devices.”¹⁶⁶ This rule forms the primary regulatory basis for NIOSH’s management and control of respirator development, approval, marketing, and postmarket surveillance.

NIOSH is comprised of multiple divisions.¹⁶⁷ As discussed below, NIOSH’s regulation of respiratory protective devices is supported and informed by general research and surveillance work performed within its Respiratory Health Division (RHD), which administers several hazard identification and surveillance programs regarding respiratory health. Another NIOSH division—NPPTL—acts as the primary authority responsible for conducting respirator evaluation and certification.

ii. The Respiratory Health Division (RHD), a division of NIOSH

RHD is a division within NIOSH dedicated to conducting research and administering service programs to prevent occupational respiratory diseases and improve workers’ respiratory health.¹⁶⁸ RHD administers a series of programs that help in identifying workplace inhalation hazards and in surveilling worker health.

RHD’s role in hazard identification is largely implemented through its Health Hazard Evaluation (HHE) Program, which helps workers and employers identify and evaluate potential inhalation hazards in their workplace.¹⁶⁹ Under the HHE Program, RHD visits workplaces and then makes recommendations regarding inhalation (and other) hazard mitigation, which can include recommendations for respirator use.

RHD also conducts public health surveillance and epidemiological studies to better understand and identify respiratory diseases from occupational exposures. Most of RHD’s work is general and not specific to a single industry or inhalation hazard—the Work-Related Disease Surveillance System (eWoRLD), for example, presents data on multiple occupational respiratory diseases (including asbestosis, coal workers’ pneumoconiosis, silicosis, asthma, and mesothelioma).¹⁷⁰ RHD also administers a program called the Coal Workers’ Health Surveillance Program (CWHSP), which studies the causes and effects of respiratory diseases related to coal mine dust exposure and provides for health screenings and surveillance of coal miners.¹⁷¹ To administer this program, RHD coordinates with MSHA, which as noted above has primary authority over workplace safety, including respiratory use, in mines.¹⁷²

iii. The National Personal Protective Technology Laboratory (NPPTL), a division of NIOSH

NPPTL within NIOSH plays a central role in researching, evaluating, and certifying respirators. In particular, its research and testing informs the respirator standards that NIOSH recommends and OSHA implements. This subsection describes the structure of the NPPTL, before describing NPPTL’s current approach to respiratory protection, and reviewing NPPTL’s periodic work regarding postmarket surveillance (including evaluation of the continued effectiveness of stockpiled respirators).

(1) History and structure of NPPTL

NPPTL is a division of NIOSH.¹⁷³ NPPTL was established in 2001 at the request of Congress, in response to a recognized need for improved personal protective equipment for workers and for focused research into personal protective technologies.¹⁷⁴ In passing the appropriations bill that recommended establishment of the NPPTL, the Senate Report on the bill noted “the need for design, testing and state-of-the-art equipment for this nation’s … miners, firefighters, healthcare, agricultural and industrial workers,” as a result of which it encouraged NIOSH “to carry out research, testing, and related activities aimed at protecting workers who respond to public health needs in the event of a terrorist incident,” and CDC “to organize and implement a national personal protective equipment laboratory.”¹⁷⁵

NPPTL maintains offices and labs in Pittsburgh, Pennsylvania, and Morgantown, West Virginia.¹⁷⁶ As of July 2018, NPPTL had 73 full-time staff positions, with staff expertise covering the areas of science, engineering, occupational health, health communications, and quality assurance.

(2) Role and activities of NPPTL

While NIOSH as a whole is dedicated to generating and implementing new knowledge in the field of occupational safety and health, NPPTL is specifically tasked with addressing the safety and adequacy of personal protective technologies (PPTs) used by workers in their professional duties.¹⁷⁷ PPTs include respirators, clothing gowns, gloves, eye protection, and other types of protective gear.¹⁷⁸ To carry out its mission of protecting workers using PPT, NPPTL aims to develop and implement guidance for PPT, develop methods to test for PPT effectiveness for workers, create guidance to help employers and workers most effectively use PPT, and develop and evaluate PPT designs.¹⁷⁹

NPPTL accomplishes its mission by conducting scientific research, developing guidance and authoritative recommendations, disseminating information, and responding to requests for

evaluations of workplace health hazards.¹⁸⁰ NPPTL also conducts surveillance, standards development, interventions, and conformity assessment activities.¹⁸¹

NPPTL’s work in promoting occupational health and safety includes a respirator approval program as well as “post-market evaluations to increase the compliant use of PPT and improve its usability and effectiveness.”¹⁸² NPPTL also conducts worksite surveillance of hazards necessitating the use of PPT by workers, which complements the further surveillance work by RHD noted above.¹⁸³

(3) NPPTL’s respirator certification testing

NPPTL is the unit of NIOSH that conducts respirator certification testing.¹⁸⁴ NPPTL is responsible for conducting the examination, inspection, and testing of respirators used in occupational settings.¹⁸⁵ Following standard test procedures,¹⁸⁶ NPPTL evaluates and approves respirator models used in occupational settings to ensure conformity with construction, performance, and respiratory protection standards.¹⁸⁷ Respirators used in occupational settings must meet the minimum performance requirements defined in 42 C.F.R. Part 84 in order to receive approval. NPPTL also conducts site and product audits of respirators to ensure conformance with standards following approval.¹⁸⁸ Finally, NIOSH maintains a database of all respirators that have been approved by NPPTL, to help people determine if the respirator they are using or considering using is NIOSH-certified.¹⁸⁹

(4) NPPTL’s work and approach in the pandemic

During the COVID-19 pandemic, NPPTL has focused significant efforts on increasing the supply of respirators available to workers. Through these efforts, NPPTL has exhibited several ways in which it operates as an important reservoir of expertise on respiratory protection that extends beyond their responsibilities as the authority for occupational respirator certification.

To address respirator shortages associated with the COVID-19 pandemic, NPPTL is conducting a series of limited assessments for respirators in the following categories: (1) respirators that are stockpiled/beyond shelf life; (2) respirators that purport to meet an international certification standard but are not NIOSH approved; (3) respirators that have been

decontaminated; and 4) non-NIOSH-approved respirators produced by novel commercial equipment.¹⁹⁰ The purpose of these assessments is to “support the availability of respiratory protection to U.S. healthcare workers and other workers.”¹⁹¹ The results of the limited assessments are disseminated to the public via the NPPTL webpage.¹⁹²

The type of assessment NPPTL is performing varies based on the approval process the respirators have undergone: for stockpiled respirators, respirators beyond shelf life, and respirators approved under international standards similar to NIOSH-approved N95s, NPPTL is solely assessing particulate filter efficiency;¹⁹³ for internationally approved (non-NIOSH-approved) respirators and N95 respirators following decontamination, NPPTL is assessing particulate filter efficiency and change in static fit;¹⁹⁴ while for innovative N95 respirators produced by novel commercial equipment, NPPTL is assessing particulate filter efficiency and pressure difference.¹⁹⁵

As another step of the response to COVID-19, the NIOSH Respirator Approval Program (conducted by NPPTL) is accepting and prioritizing certain applications to increase the supply of NIOSH-approved respirators used by health care personnel and other workers.¹⁹⁶ Priority is given to domestic manufacturers already holding an approval.¹⁹⁷

NPPTL has also been providing guidance to manufacturers, for example, clarifying FDA’s emergency use authorizations (EUAs) as they relate to NIOSH-approved respirators.¹⁹⁸ Additionally, NPPTL has assisted in investigations of manufacturers that are charged with producing misbranded and defective masks during the COVID-19 pandemic.¹⁹⁹

b. Other authorities

This section identifies the roles of other key federal and state authorities in developing, approving, marketing, and performing postmarket surveillance on respiratory protection in the workplace.

i. Federal agencies

A variety of other federal agencies have authority over some aspects of oversight of the development, approval, marketing, or postmarket surveillance of occupational respiratory protection.

Some of these agencies have only partial or shared authority over one of these functions; others only have authority as it extends to inhalation hazards in particular workplaces (e.g., mines) or that arise in particular contexts (e.g., emergencies). This section will attempt to summarize the key agencies involved in various parts of each of these functions, including the occupational oversight functions served by other federal agencies, including FDA, MSHA, the Nuclear Regulatory Commission (NRC), and the Federal Emergency Management Agency (FEMA).

FDA is a consumer protection agency that is responsible for regulating the “safety and effectiveness” of food, drugs, and medical devices.²⁰⁰ The subsequent section on respiratory protection for the public analyzes FDA’s authority in regards to masks and respirators.²⁰¹ In general, however, these fall under FDA’s jurisdiction when they are intended for a medical purpose.²⁰² Some masks and respirators are intended for the medical purpose of occupational use in a health care setting, and thus subject to FDA regulation.²⁰³ In the past, this overlap has occasionally caused confusion: several years ago, for example, concerns arose that some medical workers were using NIOSH-approved respiratory protective devices that were not FDA cleared.²⁰⁴ To address this concern, FDA and NIOSH have coordinated their overlapping authority for respirators used in medical care workplaces via a memorandum of understanding.²⁰⁵ As a general matter, the memorandum prescribes that N95 respirators used in health care settings should be both certified by NIOSH and cleared by FDA.²⁰⁶ While this is the way that overlapping authority between NIOSH and FDA is generally handled regarding medical workplaces, FDA has relaxed requirements during emergency conditions regarding specific

hazards. In particular, FDA has issued a series of EUAs for non-NIOSH-approved respirators during the COVID-19 pandemic.²⁰⁷

MSHA is empowered by the Federal Mine Safety and Health Act both for developing and certifying respirators, as well as for enforcing safety standards within U.S. mines.²⁰⁸ By statute, MSHA is also required to take part in NIOSH’s certification functions.²⁰⁹ While MSHA technically has substantial authority over a wide range of standard-setting and oversight functions within in U.S. mines, it manages this authority via collaboration with OSHA and NIOSH for both functions. This coordination is particularly robust in regards to respirator oversight, where MSHA has established a memorandum of understanding with NIOSH whereby NIOSH has the lead role in respirator certification, while MSHA and NIOSH jointly review and approve the respirators used for mine emergencies and mine rescue.²¹⁰ That said, MSHA also retains primary responsibility for several testing and oversight requirements specific to the use of respirators in mines, including investigating complaints and potential deficiency of approved respirators that are used in mines, and for testing and approving electrical and electronic components of respirators for use in potentially explosive atmospheres (an unusual feature of some mining contexts that pose additional hazards beyond those presented in many other workplaces).²¹¹ As a result of this arrangement, NIOSH remains the primary federal authority in certifying respirators, with MSHA continuing to play a role only in regards to respirators for use in mines.

The NRC is the coordinating agency for incidents at or caused by nuclear facilities.²¹² In the event of a radiological release, the NRC is specifically responsible for providing recommendations for protective actions at nuclear facilities and for performing postincident surveillance and monitoring.²¹³

FEMA has the authority to assert an expanded role over respiratory protection in workplaces during emergencies and natural disasters.²¹⁴ When emergencies present respiratory hazards—as with COVID-19, wildfires, and radiological disasters—FEMA has a coordinating role that can affect the oversight of respiratory protection in the workplace.²¹⁵ FEMA also has the authority to play a role in emergency distributions of respiratory protection to workers and the

public. During the early COVID-19 pandemic, for example, it established “Project Airbridge” for accelerating transportation of commercially distributed PPE from international manufacturers to the United States.²¹⁶ While these responsibilities do not conflict with NIOSH’s authority of the oversight over respiratory protection, they may affect the availability and provision of PPE, including respiratory protection, in emergency circumstances.

ii. State and local authorities

State and local occupational safety and health agencies play an important role in enforcing many OSHA/NIOSH requirements.²¹⁷ In light of the substantial federal regulation of respirator certification at NIOSH, state and local authorities have traditionally played a relatively limited regulatory role in oversight of respiratory protection for workers who are not protected by RPPs. Even states with active state occupational safety agencies, such as California, routinely refer to NIOSH standards in setting requirements for occupational respiratory protection.²¹⁸

c. Stockpiling

Generally speaking, questions of supply chains and national stockpiling strategy are outside the scope of this background paper. That said, questions of stockpiling can affect the availability of PPE, especially during emergencies, including PPE for critical workers. Accordingly, and by request of the Committee, this section briefly identifies the key authorities involved in identifying and maintaining the nation’s stockpiles of respiratory protective gear for use by the public.

Federal stockpiling authority is largely governed by the Public Health Services Act, amended by the Pandemic and All-Hazards Preparedness Act (PAHPA).²¹⁹ Generally speaking, the secretary of HHS—in coordination with the secretary of the Department of Homeland Security, the director of CDC, and the assistant secretary for preparedness and response within HHS—is authorized to maintain the Strategic National Stockpile, a stockpile of drugs, vaccines, and other medical products and supplies, including respiratory protection.²²⁰ The stockpile is meant to supplement state and local medical supplies and equipment during public health emergencies.²²¹

The President has substantial authority regarding the management of national stockpiles, both as commander in chief and as the head of the executive branch. The President has the power to declare emergency, and expanded authority over stockpiling and supply chain issues in cases of emergency.²²² Under the Defense Production Act, the President can address matters of critical

infrastructure, technology, national economic security, and national public health and safety, from manmade and natural disasters, as well as wartime concerns, via a series of mechanisms that mobilize national industrial capacity.²²³ For many years, it was ambiguous under the DPA whether manufacturers could be liable in tort for the manufacture of products under the DPA,²²⁴ though after passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, it is clear that at least some respiratory protective devices certified by NIOSH are protected from state and federal contract and tort liability.²²⁵ At least in theory, FEMA is tasked with coordinating DPA activities.²²⁶ In particular, the administrator of FEMA chairs the DPA Committee, which advises on effective use of the DPA and also reports to Congress.²²⁷

d. Characterizing occupational oversight regarding development, approval, marketing, and postmarket surveillance

This section summarizes the regulatory landscape regarding oversight of workplace respiratory protection, focusing particularly on the protection of workers who are currently not addressed by RPPs, and on oversight of development, approval, marketing, and postmarket surveillance. The paper attempts to identify the source of any gap, overlap, or miscoordination, so that the Committee’s eventual recommendations can be tailored to the legal basis underlying those challenges.

Among the topics addressed by this background paper, the matter of oversight of occupational respiratory protection is the most centralized and least fragmented. The primary responsibility for overseeing development, approval, marketing, and postmarket surveillance of occupational respiratory protection clearly falls under the authority of NIOSH, and within NIOSH, within the purview of NPPTL. While other agencies, such as FDA, have authority over oversight of occupational respiratory protection for certain workers (in the case of FDA, medical workers), and other agencies, such as MSHA, have authority over occupational respiratory protection for certain workplaces (in the case of MSHA, mines), these agencies coordinate their requirements with NIOSH’s—supplementing only where there are distinctive features of the work environment that present unusual risks (as with MSHA’s management of explosive

atmospheres) or where the agency’s jurisdiction extends into additional oversight concerns (as with FDA’s jurisdiction over respirator misbranding)—rather than displacing the NIOSH standards. Furthermore, because of the expansive federal role in this area, state authority appears limited.

Because the authority for managing oversight of occupational respiratory protection is so concentrated under the umbrella of NIOSH, most recommendations the Committee makes in this realm would need to address NIOSH’s authority. This could be accomplished either by addressing NIOSH directly, addressing an agency that coordinates with NIOSH (such as FDA), by addressing Congress to expand NIOSH’s authority, or by addressing the President to direct prioritization with NIOSH or coordination among agencies.

Matters addressed specifically to NIOSH should be targeted toward matters over which NIOSH has existing jurisdiction. For example, the Committee might make recommendations about the standards NPPTL applies to respirators, or the process it uses to certify them; or it might encourage NIOSH/NPPTL to develop additional guidance, for example highlighting the distinctions between public and occupational use of respiratory protection, or giving guidance for safe and effective respirator use outside an RPP.

Matters addressed to other agencies should be targeted toward matters over which they have authority, or where they have overlapping authority with NIOSH. For example, the Committee could support and/or encourage further coordination between FDA and NIOSH in the matter of managing oversight of occupational respiratory protection in medical workplaces, could encourage FDA to prioritize its enforcement actions against misbranded or adulterated respirators on particular aspects, or to continue and/or extend its EUAs in the COVID-19 pandemic.

If the Committee believed that existing statutory authority was insufficient or required some other change, it is Congress that would have the authority to respond. For example, if the Committee believed that responsibility over respiratory protection oversight should be reallocated, such that, for example, other agencies’ certification or oversight regimes displaced NIOSH’s, that is a change that would have to be implemented by Congress. Congress would also be the appropriate authority to which to direct recommendations for increased appropriations to NIOSH, NPPTL, or another authority.

Finally, if the Committee believed that the oversight of occupational respiratory protection demands even further levels or types of coordination than agencies currently exhibit, that is a matter that can be addressed to the President, as well as to the agencies themselves. Further possible actions over which relevant regulatory actors have authority, including the President, are discussed in Part II below.

B. Respiratory Protection for the Public

The organization of this section echoes the structure of the first part of this paper by distinguishing between regulations regarding nonoccupational use and those regarding nonoccupational oversight (of development, approval, marketing, and postmarket surveillance of respiratory protection).

No centralized authority is responsible for respiratory protection for the public as against all hazards. While occupational respiratory hazards have centralized authorities in the National Institute for Occupational Safety and Health (NIOSH) (for addressing occupational oversight), and to some extent in the Occupational Safety and Health Administration (OSHA) (for addressing occupational use), there is no corollary in the context of public protection. As a result,

the landscape of respiratory protection for the public is substantially more complicated than that of occupational respiratory protection, with the authority for the use and oversight of respiratory protection for the public fragmented across multiple federal and state authorities, based upon the location and type of hazard. This complexity is increased by the fact that there is no centralized repository of information about which authorities are responsible for which hazards under which circumstances.

It is worth noting that these features of the regulatory landscape—the notable absence of both a centralized authority for coordinating respiratory protection for the public, and of a centralized repository for understanding the interconnections of multiple statutes, agencies, and branches in regards to public respiratory protection—present particular challenges for comprehensive treatment of public respiratory protection. Accordingly, while this paper attempts to identify and characterize key actors in the area of public respiratory protection, this section of the paper in particular cannot purport to be comprehensive. Given the fragmentation of authorities, understanding the full extent of the regulatory landscape regarding public respiratory protection could easily be a matter of full-time study.

1. Nonoccupational Use

This section addresses the question of who has the authority to regulate use of respiratory protection by the public—that is, use of respiratory protection by individuals outside their own workplaces. No single federal or state authority has the responsibility for managing all inhalation hazards or public exposures, much less for managing all use of respiratory protection by the public. However, some agencies do have authority over regulating some inhalation hazards that affect the public and over some aspects of the use of respiratory protection. This section will focus on identifying these authorities and articulating both the extent of their authority and where there appear to be existing gaps and overlaps in regulating the use of respiratory protection by the public. In particular, it explores the authority of the Environmental Protection Agency (EPA) in addressing use of respiratory protection against environmental hazards, the Centers for Disease Control and Prevention (CDC), and the Federal Emergency Management Administration (FEMA) for addressing public respiratory protection in emergency contexts. It then addresses the authority of other federal, state, and local actors.

a. The Environmental Protection Agency (EPA)

EPA is empowered by statute to regulate a variety of environmental inhalation hazards facing the public.²²⁸ This subsection describes EPA’s authority and current practice regarding the use of public respiratory protection under two of the most important of these statutes—the Clean Air Act and the Toxic Substances Control Act (TSCA)—and provides a briefer overview of EPA’s authority under other statutes. It concludes that EPA has authority to regulate some inhalation hazards faced by the public, although its authority is largely limited to environmental hazards such as those that come from exposure to toxic chemicals or air pollution, and it is not always clear how much authority EPA has to manage those hazards via respiratory protection.

i. The Clean Air Act

The Clean Air Act is the primary federal statute responsible for addressing the risks of air pollution.²²⁹ It is administered by EPA. The Act includes a number of sections that authorize EPA to take action in regards to a variety of inhalation hazards, including those posed by wildfires and hazardous air pollutants emitted by industrial sources.

(1) EPA’s general authority under the Clean Air Act

The gargantuan Clean Air Act of 1970, as substantially amended in 1977 and 1990, is the nation’s most important law addressing the problem of air pollution.²³⁰ EPA is responsible for administering the Clean Air Act and for overseeing a “cooperative federalist” structure that allows for cooperation between federal and state actors regarding the management of air quality.²³¹

The Clean Air Act’s multiple sections fit together in complex ways—indeed, the Act is so enormous and intricate that its complexity has been compared to that of the entire U.S. tax code.²³² In furtherance of its goals, the Act establishes separate approaches to regulating “criteria” pollutants that endanger public health or welfare and that come from multiple sources (including both mobile and stationary sources),²³³ and “hazardous air pollutants” that present an even greater hazard and which may be generated by only one or a few sources (such as chemical plants or other industrial emitters).²³⁴ EPA is tasked with different responsibilities and different authority regarding each of these types of pollutants. In this sense, the Clean Air Act requires a different regulatory approach for inhalation hazards posed by criteria pollutants and those posed by hazardous air pollutants.

(2) Criteria air pollutants

Criteria pollutants are those substances that “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare,” which “are present in the air due to numerous or diverse mobile or stationary sources,” and for which the administrator plans to issue air quality criteria, which are technical documents that identify the public health

and welfare effects of the pollutant.²³⁵ The administrator of EPA is directed to issue National Ambient Air Quality Standards (NAAQS) to control pollutants listed as criteria pollutants at a level that is “requisite to protect the public health” and allows “an adequate margin of safety.”²³⁶ Currently, EPA has issued NAAQS for six criteria pollutants: carbon monoxide, lead, nitrogen dioxide, particulate matter (separately set for particulate matter smaller than 10 microns and fine particulate matter smaller than 2.5 microns), ozone, and sulfur oxides.²³⁷ To implement the NAAQS, the Clean Air Act relies upon a cooperative federalist structure that assigns significant authority to states to develop State Implementation Plans (SIPs) for achieving the NAAQS that have been set by EPA.²³⁸ SIPs are subject to review by EPA, which has the authority to replace them with Federal Implementation Plans (FIPs) if the SIPs fail to meet required standards.²³⁹ States are also subject to more stringent federal regulation of new or modified sources of air pollution if they fail to attain the NAAQS (a status called “nonattainment”) than if they achieve the NAAQS (a status called “attainment”).²⁴⁰ EPA administers a series of performance standards for new and modified stationary sources,²⁴¹ as well as permit systems that grant or deny permits to new and modified stationary sources of air pollution based upon the expected pollution created by the source, and the location in which the source is opening.²⁴² Mobile sources of criteria air pollution are regulated under a separate set of provisions.²⁴³ These generally limit interstate variability by requiring mobile sources of criteria pollutants either to meet federal standards or to adopt California’s more stringent air pollution standards.²⁴⁴ As a result of these statutory choices, criteria pollutants are regulated via uniform, nationwide ambient air quality standards that address the sources of air pollution rather than exposures to that pollution.

While EPA has broad discretion in interpreting ambiguous language within the Clean Air Act,²⁴⁵ there does not appear to be language in the Clean Air Act that would allow EPA to substitute personal respiratory protection for source control. And indeed, neither EPA nor any state (via SIPs) appear to have ever incorporated public respiratory protection into standards for satisfying the NAAQS.

(3) Regulation of hazardous air pollutants (HAPs)

HAPs are pollutants that are “known or suspected to cause cancer or other serious health effects, such as reproductive effects or birth defects, or adverse environmental effects.”²⁴⁶ Congress established an initial list of 189 pollutants, to which EPA has the authority to add; these include substances such as asbestos, benzene, vinyl chloride, and mercury when those substances are airborne.²⁴⁷

The approach used to control HAPs differs from the approach the Clean Air Act uses for criteria pollutants. While control of criteria air pollutants relies on the cooperative federalist partnership between the states and EPA, the HAP regime empowers EPA to directly regulate emissions sources of HAPs, on the theory that the dangers posed by inhalation of such pollutants are so severe that they justify more direct federal control.²⁴⁸

Under the 1990 Amendments to the Clean Air Act, EPA has two mechanisms for controlling HAP emissions: setting technology-based standards for controlling emissions from HAP sources and implementing a health-based standard as a backstop. The technology-based standard imposes control technology requirements on sources, varying the stringency and type of technology required according to the size and category of the source.²⁴⁹ Once a floor standard of safety is achieved with these technology-based emissions standards, the administrator is empowered to consider whether “beyond-the-floor” standards are achievable in light of “the cost … and any non-air quality health and environmental impacts and energy requirements.”²⁵⁰

Finally, and unusually, 8 years after the promulgation of technology-based emission standards, the administrator is required to consider promulgation of a health-based standard to address “residual risks” to address remaining health risks that exist even after the promulgation of the technology-based standard.²⁵¹ This health-based standard “shall provide an ample margin of safety to protect public health … unless the Administrator determines that a more stringent standard is necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.”²⁵²

The exact mechanisms through which these standards are supposed to operate is ambiguous, and EPA has struggled to find meaningful ways to enforce them.²⁵³ One of Congress’s primary goals in issuing the 1990 Amendments to the Act, in fact, was to encourage EPA to be more active in regulating HAPs.²⁵⁴ Even after the 1990 Amendments, however, HAPs have generally received lower priority among air pollution policies,²⁵⁵ and EPA has taken relatively few actions to regulate residual risks.²⁵⁶ It is clear, however, that residual risk standards are supposed to work as a supplement to the technology-based standards that precede them. As a result, there may be some room for discretion for EPA in considering approaches to HAP control that are based on respiratory protection rather than source control. Indeed, such a program might help EPA as it continues to consider how residual risks of HAPs can be meaningfully managed after technology-based standards have failed to achieve an ample margin of safety to protect public health against HAPs.

(4) EPA’s practice regarding the regulation of inhalation hazards from air pollution

The Office of Air and Radiation within EPA is the office responsible for implementing the Clean Air Act and thus the office with primary authority for managing inhalation hazards from air pollution.²⁵⁷ Most of the Office of Air and Radiation’s attention and resources are focused on source control. However, some of EPA’s programs also include treatment of or guidance regarding respiratory protection. These include some aspects of EPA action regarding wildfires and indoor air quality. EPA also maintains databases and tools for public communication of hazards from air pollution, including the Air Quality Index (AQI), a tool designed and implemented to communicate air quality to members of the public.

EPA maintains substantial public resources regarding wildfire, including guidance for the public on how to address high levels of wildfire-related air pollution with respiratory protection.²⁵⁸ For example, EPA has developed an infographic with information on reducing exposure to wildfire-related air pollution, highlighting that “[t]he right respirator and proper fit can reduce your exposure to wildfire smoke.”²⁵⁹ It notes that “[r]espirators are not designed to fit

children,” and that “[f]acial hair prevents proper fit and reduces effectiveness”²⁶⁰—though it does not advise on how to address these challenges. EPA also maintains a downloadable app—the Smoke Sense app—to help members of the public learn about health risks from wildfire smoke in their area, and to advise them to take actions to reduce exposure, such as wearing a well-fitting N95 respirator.²⁶¹

Although EPA has long interpreted its authority under the Clean Air Act to apply only to outdoor air,²⁶² it has adopted a number of voluntary programs addressing indoor air quality.²⁶³ As part of these projects, EPA has provided consumer information on best practices for remodeling, reducing radon, and advice on adequate and proper ventilation, many of which include advice about public use of respiratory protection.²⁶⁴ In the COVID-19 pandemic, it has also issued information to the public regarding coronavirus and indoor air.²⁶⁵

EPA also maintains the AQI, a color-coded, numerical index of air pollution levels.²⁶⁶ The index characterizes the health hazards posed by exposure to outdoor air within bands running from “good” air quality (0–50 on the index; “Air quality is satisfactory, and air pollution poses little or no risk”) to “hazardous” (301 and higher on the index; “Health warning of emergency conditions: everyone is more likely to be affected”).²⁶⁷ EPA routinely recommends behaviors to the public to reduce exposure based upon the AQI. For example, when air pollution levels are “moderate” (50–100 on the AQI) it recommends that “if you are unusually sensitive to particle pollution, consider reducing your activity level or shorten the amount of time you are active outdoors.”²⁶⁸ However, the AQI tool does not appear to attach respiratory protection

recommendations to various AQI levels or to distinguish between the need for respiratory protection for various groups.²⁶⁹

Finally, EPA maintains a National Air Toxics Assessment as an ongoing review of air toxics as a screening tool for state and local air agencies and stakeholders to help in identifying which pollutants, emissions sources, and places may generate risk to public health from air toxics.²⁷⁰

(5) Characterizing EPA’s approach under the Clean Air Act

In one sense, all of the Clean Air Act is dedicated toward addressing inhalation hazards for the public, since the Act is dedicated toward controlling air pollution and is even more specifically dedicated toward addressing the human health and welfare effects of that pollution.²⁷¹ EPA generally protects health and welfare by controlling the source of air pollution, however, rather than relying on personal protective equipment. In some cases—as with regulation of sources of criteria pollutants—EPA appears to be locked into this focus on source control via the authority granted in the statute it administers. In other cases—as with residual risk regulation under the HAP regime—EPA could consider whether adding provision of personal protective gear could help it in satisfying some of its statutory obligations. Finally, in part because of its administration of the gargantuan Clean Air Act, EPA has substantial expertise about inhalation hazards, on which it is empowered to build to issue guidance and/or to provide public information.

ii. The Toxic Substances Control Act (TCSA)

TSCA, as amended by the Frank Lautenberg Chemical Safety Act for the 21st Century (Lautenberg Act), is the primary federal statute responsible for addressing the risks of exposure to toxic substances.²⁷² EPA has broad authority under TSCA to regulate inhalation hazards from public exposure to substances, so long as those substances qualify as “toxic substances” under TSCA. Understanding the extent of EPA’s authority in this realm therefore requires both an understanding of EPA’s authority under the statute, the general definition of toxic substances under TSCA, and the way that the statute exempts some substances from regulation under TSCA (specifically where those substances are sufficiently regulated under other statutory regimes).

(1) EPA’s authority under TSCA

TSCA is administered by EPA, and directs EPA to regulate chemicals that “present an unreasonable risk of injury to health or the environment,”²⁷³ whether those risks are to workers or to the general public.²⁷⁴ EPA’s authority under TSCA was further expanded in 2016 with an important amendment to TSCA—the Lautenberg Act—which established new standards for identifying how and which substances must be tested for toxicity and which changed the trigger for EPA action under the statute.²⁷⁵ The amended TSCA requires EPA to gather information regarding potential chemical risks, to prioritize chemicals for risk evaluation based upon the gathered information, and to regulate chemicals that present unreasonable risks to ensure they no longer do so.²⁷⁶

Under TSCA, EPA has broad authority to identify the mechanisms that are best-suited to address the risks from exposure to toxic substances.²⁷⁷ This includes mandating use of respiratory protection, as evidenced by EPA’s past use of TSCA to mandate use of respiratory protection against asbestos by workers.²⁷⁸ As discussed above in the section addressing workplace protections, EPA has coordinated with OSHA in the past to create regulations mandating use of respiratory protection regarding asbestos.²⁷⁹ While these regulations applied specifically to workplace exposures, TSCA itself does not limit EPA’s authority to workplace environments.²⁸⁰ Indeed, EPA’s past coordination with OSHA to apply use protections to state and local workers helps illustrate the broader reach of EPA’s authority under TSCA, particularly in comparison to OSHA’s reach under the Occupational Safety and Health Act (OSH Act).²⁸¹

(2) Exceptions to TSCA and overlaps with other federal authority

TSCA was originally passed with the intention of filling gaps in EPA’s authority left by previous environmental statutes and was thus intended to confer significant authority on EPA to address substances that might otherwise be insufficiently regulated.²⁸² That said, in passing TSCA, Congress was aware of the possibility of overlap between TSCA and other federal

laws.²⁸³ To balance this concern with the goal of protecting the public from the risks associated with toxic substances, the statute allows EPA to defer to another agency if the administrator of EPA believes that a law administered by the other agency could be used to prevent or sufficiently reduce an unreasonable risk to health or the environment presented by a chemical substance or mixture.²⁸⁴ For example, in 1985, EPA referred 1,3-butadiene to OSHA when it found that exposure to the substance posed an unreasonable risk, but one that could be dealt with effectively within workplace safety standards.²⁸⁵ In addition, substances that are already regulated by other federal authorities or under other statutes, such as food and pesticides, are excluded from regulation under TSCA.²⁸⁶ Section 9 of TSCA also contains a number of exemptions for otherwise-toxic substances when those substances are managed under other regulatory schemes.²⁸⁷

(3) Other statutes administered by EPA

EPA administers a long list of environmental statutes,²⁸⁸ including—in addition to the Clean Air Act and TSCA—the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA);²⁸⁹ the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA);²⁹⁰ and the Emergency Planning and Community Right-to-Know Act (EPCRA).²⁹¹ These statutes give EPA authority over a wide range of environmental issues, including regarding some environmental inhalation hazards.

EPA actions under these statutes may sometimes inform public use of respiratory protection. That said, the statutes generally rely on mechanisms other than respiratory protection—particularly source control—to address environmental (including inhalation) hazards. The EPCRA, for example, requires EPA to maintain a Toxics Release Inventory to inform the public about the emissions (including air emissions) of highly dangerous chemicals.²⁹² Members of the public might theoretically use this information to seek respiratory

protection where needed, though it does not appear that EPA provides explicit guidance to that effect, either to individuals or to communities.²⁹³

Other connections between EPA authority and public respiratory protection seem somewhat tangential. For example, FIFRA allows EPA to determine which pesticides are beneficial enough (given the risks they pose) to be sold in U.S. commerce.²⁹⁴ To determine whether or not a pesticide’s risks outweigh its benefits, the agency may take account of public welfare and public exposures to the pesticide (which might theoretically be affected by personal protective equipment use, although no such consideration is mandated by the statute). In administering this statute, EPA is responsible for administering a worker protection program in regards to pesticides, which mandates respiratory protection, as discussed above,²⁹⁵ though it does not appear to administer any similar system for respiratory protection for consumer users of pesticides.

(4) Characterizing EPA’s approach under TSCA

EPA is the primary authority for regulating inhalation hazards from environmental sources and has collected substantial expertise regarding exposure and hazards presented by various air pollutants and toxic substances.

EPA’s approach to regulating inhalation hazards facing the public has thus far varied under the differing statutes it administers. That said, there appears to be no centralized program within EPA for addressing public respiratory protection against environmental hazards. Instead, EPA has issued a variety of guidance under various statutory regimes, via several of its many divisions, regarding different respiratory hazards.

Recommendations to EPA regarding its regulation of inhalation hazards, and use of respiratory protection, are most likely to be effective where they target matters over which EPA has discretion. Such recommendations might address, for example, expanding guidelines for public respiratory protection, for example, those EPA makes as part of its AirNow/AQI program. In some cases, further consideration of the possibility of encouraging respiratory protection as a backstop to source control might even help EPA in addressing long-term statutory puzzles, such as how to best implement the requirements of the health-based residual risk backstop in the HAP regime.

Where the Committee believes that the statutes empowering EPA should be amended, it should direct its commentary toward Congress. For example, if the Committee believed that EPA should be permitted to consider respiratory protection as a backstop to source control of criteria

pollutants, such a change would need to be made to the underlying statute and could not be implemented via agency action alone.

b. The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS)

This section summarizes CDC’s role in regulating the use of respiratory protection by the public. It identifies the general structure and authority of CDC, including divisions within CDC that serve important functions in regards to respiratory protection against some hazards, and summarizes CDC’s current approach to regulating public use of respiratory protection.

i. CDC’s statutory authority regarding inhalation hazards and public health

CDC is a national public health agency whose mission is to “serve[] as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities designed to improve the health of the people of the United States.”²⁹⁶ This mission is situated within the general public health goals set out in the Public Health Service Act, which authorizes the secretary of HHS—of which CDC is part—to “conduct in the [Public Health] Service … research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental disease and impairments of man.”²⁹⁷

Although CDC is not restricted to dealing with public inhalation hazards, its authority bears on the regulation of those hazards in two important ways. First, CDC has a number of direct responsibilities relating to the control of infectious disease, as well as the authority to implement its recommendations regarding the spread of infectious disease. In some cases, such recommendations may bear on respiratory protection. Second, various agencies within CDC—including NIOSH, the National Center for Environmental Health (NCEH), and the Agency for Toxic Substances and Disease Registry (ATSDR)—play more specific roles in regulating public inhalation hazards.

(1) CDC’s role in public respiratory protection

Over the years, CDC has issued a variety of guidance and public information designed to communicate with the public about its use of respiratory protection. For example, it has issued significant information for members of the public entering homes that have been flooded, to help in mitigating the hazards posed by mold inhalation.²⁹⁸ This information includes recommendations about the use of respirators.²⁹⁹

In addition to its general responsibilities as a national public health agency, CDC has particular authority regarding inhalation hazards posed by infectious disease.³⁰⁰ For example, CDC is authorized to take measures to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States or from one state to another.³⁰¹ These activities address inhalation hazards from communicable respiratory diseases, such as the coronavirus pandemic.

CDC has taken a number of specific actions regarding the inhalation hazards posed by coronavirus during the pandemic. For example, pursuant to its statutory authority regarding control of infectious disease in interstate travel,³⁰² it issued an emergency action requiring the use of face masks on public transportation conveyances and at transportation hubs.³⁰³

(2) Role of agencies within CDC

A number of agencies exist within CDC that also take actions relevant to protection of the public from inhalation hazards. These include NIOSH, whose statutory responsibilities are directed toward occupational safety and health but which still takes some actions related to respiratory protection for the public, and NCEH/ATSDR, which plays a role in researching and coordinating response to environmental hazards.

a. The National Institute for Occupational Safety and Health (NIOSH)

NIOSH is an agency within CDC. While NIOSH operates within CDC, however, it is primarily empowered via the OSH Act, as discussed in more detail above.³⁰⁴

The statutory authority of NIOSH, which was created under the OSH Act, is directed toward workers rather than the public.³⁰⁵ Indeed, NIOSH’s mission, goals, and objectives are limited to occupational settings.³⁰⁶ Notably, and consistently with this limitation, NIOSH’s certification systems—such as those implemented by the National Personal Protective Laboratory (NPPTL)—are directed toward researching and evaluating respirator protection for workers, rather than toward researching and evaluating respiratory protection for the general public.³⁰⁷

Despite its general lack of statutory mandate regarding public safety and health, NIOSH and its division of NPPTL have taken a number of voluntary actions drawing upon their expertise and directed toward public protection from respiratory hazards.

Some of these actions are part of NIOSH’s general research function and/or operate as an extension of NIOSH’s occupational functions. For example, NIOSH maintains a list of which respirators are approved by NIOSH, how to get them, and how to use them;³⁰⁸ this list is available to members of the public seeking respirators for personal use, as well as to employers and employees seeking them for occupational use.

Other actions have been undertaken during or in response to public emergencies. For example, NIOSH developed a program to respond to the respiratory hazards presented by the terrorist attacks of September 11, 2001, focusing on the respiratory hazards and needs of first responders regarding chemical, biological, radiological, and nuclear agents, and has been granted special statutory authority to provide special programs to support health and safety research for World Trade Center survivors (including members of the public).³⁰⁹

Finally, and as discussed further subsequently,³¹⁰ NIOSH/NPPTL’s respirator certification program for occupational safety and health is routinely used as a touchstone for other agencies when they are making recommendations to the public about respiratory safety and health.

b. The National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry (NCEH/ATSDR)

NCEH and ATSDR are both agencies situated within CDC. Although each have specific roles to play in regards to protection from inhalation hazards, the two agencies often act together and in fact are currently headed by a single director.³¹¹

NCEH is a research agency within CDC that is responsible for researching, directing, and coordinating protection from environmental hazards.³¹² It performs and coordinates applied research on a number of environmental hazards, including inhalation hazards; engages in public communication and education; and takes part in public health emergency training.³¹³

ATSDR was created to implement the health-related sections of laws that protect the public from hazardous wastes and environmental substances.³¹⁴ It is responsible for protecting communities from harmful health effects from exposure to toxic substances.³¹⁵

NCEH/ATSDR often collaborate with other agencies, particularly EPA, in drafting guidance documents on respiratory protection,³¹⁶ as well as in evaluating and addressing the hazards posed by hazardous wastes and chemical substances. ATSDR in particular has a set of statutory responsibilities stemming from the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) and the Resource Conservation and Recovery Act of 1976 (RCRA), both administered by EPA, which require ATSDR to assist EPA in determining which substances should be regulated and the levels at which substances (including inhaled substances) may pose a threat to human health.³¹⁷

In combination, NCEH/ATSDR establish a significant reservoir of expertise regarding the health impacts of respiratory and other environmental hazards within CDC. Notably, these agencies—unlike NIOSH—are focused on health hazards to the public. Currently, there does not appear to be a division of NCEH/ATSDR that works as a corollary to NPPTL in NIOSH.

c. The Federal Emergency Management Agency (FEMA)

FEMA is the federal agency responsible for managing critical response to national emergencies. FEMA’s authority is unusual among federal agencies because it is tied to emergencies, and thus tends to be both time- and subject-limited. That said, during emergencies, FEMA has substantial and broad-ranging authority that can apply to the approval, marketing, surveillance, and provision of respiratory protection. Emergencies that can trigger FEMA’s authority include natural hazards—such as wildfires and floods—which can generate respiratory hazards (such as particulate matter and mold).³¹⁸ Other specific types of disaster—most notably radiological disaster³¹⁹—trigger special responsibilities by other agencies.

The Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) identifies FEMA’s statutory authority for most federal disaster response activities, as well as establishing the presidential disaster declaration process.³²⁰ Under the Stafford Act, FEMA is

empowered to coordinate national response and to assist state and local governments during “natural catastrophes.” As noted below, FEMA also has responsibilities in the case of invocation of the Defense Production Act (DPA).³²¹

FEMA has issued a series of temporary final rules attempting to manage the distribution and availability of personal protective gear during the COVID-19 pandemic.³²² These rules limit, for example, the export of health and medical resources, including respirators, without FEMA’s consent.³²³ As part of its response to the COVID-19 pandemic, FEMA has also issued an interim final rule to establish an “Emergency Management Priorities and Allocations System” (EMPAS), to establish procedures for FEMA to allocate materials, services, and facilities during emergencies, and for deciding which orders and contracts (e.g., of respirators) to prioritize over others.³²⁴ For example, in May 2020, during the early coronavirus pandemic, FEMA sent personal protective equipment (PPE), including cloth masks, to nursing homes around the country.³²⁵ In issuing the distribution order, FEMA cited “the critical need for PPE at nursing homes where some of our Nation’s most vulnerable residents live”³²⁶; in this sense, FEMA’s allocations were justified by concern over public, rather than (just) workplace, safety.

d. Other authorities

This section identifies the roles of other important authorities in regulating the use of respiratory protection by the public. It identifies additional federal agencies that participate in regulating respirator use, as well as state and local actors with important authority.

i. Other federal authorities

As noted above, there appears to be no comprehensive accounting for all the federal agencies whose responsibilities extend to respiratory protection for the public against inhalation hazards. Agencies with at least some authority over some inhalation hazards would include agencies whose statutory authority extends to methods of public conveyance, including divisions of the Department of Transportation, such as the Federal Aviation Administration³²⁷; and agencies that have authority over particular inhalation hazards, such as the Nuclear Regulatory Commission’s responsibilities regarding nuclear hazards.³²⁸ Other agencies provide information that is used by the public in identifying which respiratory protection to use; OSHA’s Safety and Health Information Bulletins on respiratory protection, for example, are sometimes recommended to members of the public seeking respiratory protection.³²⁹ Still others recommend the use of respiratory protection under some circumstances; for example, the Consumer Product Safety Commission (CPSC) recommends respirator use to the public when using hazardous products, though it typically refers back to OSHA standards and NIOSH certification when making those recommendations.³³⁰

In addition, in the absence of legislation creating a comprehensive system for public respiratory protection, the executive branch has substantial authority to issue “gap-filling” enforcement and executive actions to require respiratory protection for the public in those areas where there is federal jurisdiction. During the recent pandemic, this authority has been used to create “mask mandates” on federal properties that apply to members of the public.³³¹

ii. State and local authorities

Generally speaking, in the absence of a coherent federal regime addressing public respiratory protection, significant authority is left to the states to create and administer schemes for assuring adequate public protection. While the approach of states varies, two legal approaches to achieving such protection are particularly worth flagging: state regulations that attempt to proactively regulate and/or oversee respiratory protection for the public, and judicial liability regimes—particularly in tort—that affect liability of manufacturers and sellers of

respiratory protection, and which thus may influence the development and availability of respiratory protection for public use.

(1) Proactive regulatory regimes

States may choose to address respiratory protection for the public via proactive regulatory regimes, when those regimes have not been preempted by comprehensive federal action. Variation in state laws addressing public respiratory protection have been particularly salient during the coronavirus pandemic. While no state has issued public mandates for respirators—that is, respiratory protection that would protect wearers from airborne infection—many states have issued “mask mandates” requiring face covering.³³² The specific requirements, duration, and enforcement of these mandates has varied by state.³³³ Generally speaking, however, management of source control through mask mandates is legally justified by states’ “police power,” which gives them authority over matters of general public safety,³³⁴ and by states’ authority to declare and enforce quarantine within their borders.³³⁵ Such power is particularly broad where, as is the case with the coronavirus pandemic, no federal action (such as action by the surgeon general to “prevent the introduction, transmission, or spread of communicable diseases from … one State or possession into another State or possession”³³⁶) preempts state authority on communicable diseases.³³⁷ And indeed, despite federal authority to intervene in quarantine matters where

required to address spread of communicable disease, CDC has a history of deferring to state and local health authorities in their use of quarantine powers regarding communicable diseases.³³⁸

States and local authorities, such as counties and municipalities, also play an important role in emergency planning, including as required under the Emergency Planning and Community Right-to-Know Act,³³⁹ though such requirements do not currently appear to extend to provision of or advice regarding respiratory protection.³⁴⁰

(2) Liability regimes

In addition to prospective regulatory frameworks above, an additional legal factor that may affect the use and availability of respirators for the public is retroactive liability in tort. Torts are civil wrongs, and can arise when a wrong by one person or company causes harm to another.³⁴¹ Torts generally arise out of state law, and are often adjudicated in state courts.³⁴² In some cases, specific rules in tort have been codified by state legislators via state statutes.³⁴³ In most cases, however, tort law has been created via judge-made common law, which has developed over decades of case law and through the creation of judicial precedent.³⁴⁴

In environmental and public health contexts, tort law acts as a backstop for the types of proactive regulatory standards that this paper has discussed thus far.³⁴⁵ It provides an additional set of incentives for manufacturers and sellers of respirators and other protective gear, and thus forms a part of the regulatory landscape that can affect what actions firms and individuals take in

regards to manufacturing, selling, and marketing respiratory protection to the public.³⁴⁶

Different kind of torts recognize different kinds of wrongs that people can do to one another. Two types of torts with potential impact on the design, manufacture, and sale of respirators to the public are products liability and fraud. Fraud is discussed in more detail in the subsequent subsection, as it bears particularly on state law oversight of respiratory protection.³⁴⁷

Products liability is an area of law that seeks to ensure that products are reasonably safe.³⁴⁸ Products liability is “strict,” in that product designs or manufacturing defects that cause people harm trigger liability for any damage that is caused.³⁴⁹ As a result, in many cases, designers, manufacturers, and sellers of protective gear, including respirators, can be liable in products liability if their products cause harm to others—even if the product was designed and manufactured according to regulatory standards such as those set by NIOSH for N95 respirators.³⁵⁰

There is ongoing scholarly debate over whether stringent state liability regimes promote or deter the safe manufacture and sale of protective devices.³⁵¹ In some cases, scholars have suggested that robust state products liability regimes could stymie innovation and availability of public respiratory protection, and/or that existing judicial doctrines of preemption—which thus far have generally³⁵² allowed for state tort claims in products liability even where the product otherwise complies with product safety statutes or administrative regulations³⁵³—should be reconsidered in the case of respiratory protection.³⁵⁴ Thus far, however, tort liability remains a

possible concern for product designers, manufacturers, and sellers, even where respirators sold comply with existing federal regulations.

e. Characterizing nonoccupational use

There is no single federal entity responsible for regulating the use of respiratory protection by the public, though there are a number of federal agencies responsible for regulating specific types of respiratory hazards that might require or be addressed by respiratory protection. Among these agencies, EPA and CDC have the broadest mandates. Notably, even agencies that have authority over some inhalation hazards, and that choose to encourage use of respiratory protection by the public, often refer to NIOSH standards—standards developed for occupational contexts, for a population of workers—when making recommendations to the public.³⁵⁵ This practice is potentially problematic where the population NIOSH addresses—e.g., adults—is different than the public in important ways. The result is that some members of the public—notably, children—may not be served even by agencies’ general recommendations about the type of respiratory protection to use against inhalation hazards. In the absence of comprehensive federal action on public respiratory protection, state and local law also plays a role in the use, provision, and availability of respiratory protection for the public, although this role varies by state and by hazard.

2. Nonoccupational Oversight

This section describes the regulatory landscape regarding the oversight of respiratory protection development, approval, marketing, and/or postmarket surveillance, when that oversight applies to respiratory protection for the public rather than for workers. While there is a clear authority for this type of oversight regarding occupational settings—where most authority rests clearly with NIOSH—there is no similar centralized authority for oversight of nonoccupational respiratory protection for the public. The agency with the broadest authority is likely the Food and Drug Administration (FDA), although even its authority is limited—in its case, to respiratory protection intended for medical purposes. The section describes FDA’s authority, including the limits on that authority, as well as the limited roles of the CPSC and NIOSH. It then discusses the roles of other federal, state, local, and foreign actors.

a. The Food and Drug Administration (FDA) within HHS

FDA, a public health agency within HHS, is responsible for regulating food, drug products, and medical devices.³⁵⁶ When respiratory protection is provided by a medical device that is intended for a medical purpose, such as preventing disease, it is subject to regulation by FDA, both via potential premarket approval processes, and through controlling device adulteration and misbranding. Respiratory protection that is not intended for a medical purpose is not subject to FDA oversight or control.

i. The general authority of FDA under the FD&C Act regarding use of respiratory protection by the public

FDA’s authority regarding respiratory protection traces to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Medical Device Amendments of 1976 (MDA). In addition to granting FDA a variety of consumer protection responsibilities related to the regulation of food and drugs, these statutes require FDA to regulate “adulterated” and “misbranded” devices, and to ensure devices’ “safety and effectiveness.”³⁵⁷

To qualify as a medical “device” under the FD&C Act, an item must be intended for a medical purpose.³⁵⁸ Items are considered to be used for a medical purpose when they are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”³⁵⁹ The FD&C Act is ambiguous as to what it means for items to be “intended” for a purpose, leaving FDA with substantial discretion in deciding when a device is intended for medical purposes and when it is not. Under FDA’s current interpretation, in deciding whether any particular item is intended for a medical purpose, it will consider whether the item is labeled or otherwise intended for use by a health care worker; labeled or otherwise for use in a health care facility or environment; and/or includes any drugs, biologics, or antimicrobial/antiviral agents.³⁶⁰ FDA retains discretion, however, to revisit or change this interpretation, so long as it remains within the bounds of the statute.

ii. FDA regulation of respirators

FDA has authority under Section 201(h) of the FD&C Act to regulate face masks and respirators when they meet the statutory definition of a medical “device.”³⁶¹ Within FDA, the Center for Devices and Radiological Health is the division that implements rules and requirements regarding medical devices.³⁶²

FDA has long had special responsibilities regarding the regulation of adulterated or misbranded devices.³⁶³ Generally speaking, devices are “adulterated” if they include filthy, putrid, or decomposing substances; if they are packed under unsanitary conditions; or if their manufacturer violates performance standards or good manufacturing practices. And they are misbranded if they are labeled in a false and misleading matter; if its packaging does not bear required labels, including directions for use; or if it is dangerous to health when used in the

manner suggested on the labeling.³⁶⁴ When adulterated or misbranded devices are in interstate commerce, they are subject to seizure and other penalties.³⁶⁵ As a result, FDA has substantial authority in regards to the marketing and postmarketing surveillance of respirators that are intended for a medical purpose. It has no authority, however, over identical respirators that are not intended for a medical purpose.

Since passage of the Medical Device Amendments of 1976 (MDA), FDA has also had the authority to regulate premarket approval processes for new medical devices.³⁶⁶ To satisfy its statutory mandate, FDA must evaluate all medical devices to “provide reasonable assurance of the safety and effectiveness of the device,” and then classify them based on the level of risk that they present to consumers.³⁶⁷ Class I devices are considered low risk and are minimally regulated; Class II are considered moderate risk and are subject to special controls, including performance standards, postmarket surveillance, and other actions FDA deems necessary; and Class III devices are high-risk and are additionally subject to a robust premarket approval process.³⁶⁸ FDA designations of this type generally receive significant deference from courts,³⁶⁹ and FDA retains the authority to redesignate among these classifications if it feels that it has misidentified the level of risk that a particular device poses to the public.

During the coronavirus pandemic, FDA has claimed authority under the FD&C Act to regulate all face masks, shields, and respirators that are used for a medical purpose, including N95 respirators used to prevent infection with the COVID-19 virus.³⁷⁰ The same respirators are not considered “devices” when they are intended for a nonmedical purpose, such as for use in construction.³⁷¹

Under current FDA classifications, face masks that are not surgical masks are regulated as Class I devices,³⁷² and thus are not subject to performance standards or postmarket

surveillance, while surgical masks and respirators are regulated as Class II devices³⁷³ and are subject to such standards and surveillance.

iii. Characterizing FDA’s approach

FDA’s authority over the development, approval, marketing, and postmarket surveillance of items used in respiratory protection is significant when those items are used for a medical purpose, including for the prevention of disease (such as the COVID-19 virus). In such cases, they have significant authority over development and approval, particularly of Class II medical devices such as N95s, which must meet FDA performance standards, as well as requirements of postmarket surveillance. FDA also has substantial authority over marketing and postmarket surveillance of other items that qualify as medical devices—including surgical masks when intended for medical purposes—via its authority to address adulterated and misbranded devices.

In some cases, FDA’s governance of respirators (only) when they are used for a medical purpose, but not when they are intended for a different use, may lead to awkward overlap with other authorities. This is particularly true where the same device (such as an N95 respirator) is developed for multiple uses, only some of which are medical. FDA only claims jurisdiction over devices when their purpose is medical, as with the prevention of disease.³⁷⁴ Many inhalation hazards—including environmental hazards—can produce diseases such as cancer; however, it can be difficult to determine just how far FDA’s authority reaches. Thus far, FDA does not appear to have claimed authority to regulate all respiratory protection in all circumstances that protects against any inhalation hazard that can cause any disease, and it has specifically disclaimed authority, for instance, over N95s used in “construction”³⁷⁵—where, of course, N95s are used and often required (including, in occupational contexts, as part of OSHA-required respiratory protection programs) in part to protect against occupational and environmental exposures that can cause diseases such as silicosis, asbestosis, and cancer.

The question of just how far FDA’s authority stretches over respirators as devices, and how it interacts with the authority of EPA, OSHA, and other authorities, thus remains ambiguous. And the case is made still more complex by the fact that while courts generally defer to statutory interpretations that involve an agency’s own authority under a statute it administers, courts are significantly less deferential when it comes to interpretations of statutes administered by other agencies.³⁷⁶ Thus while FDA might be able to interpret its own authority over medical devices broadly, it is not presumed to have any particular expertise in determining the countervailing authority of, for example, EPA in regulating toxic substances. In such areas of

potential interagency overlap, it can be particularly helpful to have clarification of agencies’ roles, either through interagency coordination (led by the agencies themselves, or as encouraged by the President), or to have Congress clarify the appropriate scope of the various agencies’ responsibilities by passing new legislation addressing the area of overlap. Part II expands on the types of actions these different actors can take in regards to situations like this one, where the far extent of authority an agency (in this case FDA) has over a particular important issue (in this case the oversight of respiratory protective devices that are intended for use for a “medical purpose”) remains unclear.

b. The Consumer Product Safety Commission (CPSC)

The CPSC oversees consumer products produced or distributed in the United States for sale to, or use by, consumers.³⁷⁷ Its authority stems from the Consumer Product Safety Act (CPSA)³⁷⁸ and the Federal Hazardous Substances Act (FHSA).³⁷⁹ It is relevant to inhalation hazards that the public may face as the result of exposure to products, such as household cleaning agents. It also plays a limited role in regulating some forms of face coverings against flammability risk.

Under the FHSA, the CPSC has the authority to ban or regulate substances—such as cleaning agents³⁸⁰—that are hazardous and that may cause substantial injury or illness.³⁸¹ “Hazardous substances” include substances that are radioactive, toxic, corrosive, are an irritant or sensitizer, are flammable or combustible, or generate pressure through decomposition, heat, or other means, “if such substance … may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.”³⁸² “Toxic substances” includes substances that have the capacity to act as hazards via inhalation.³⁸³ Under the CPSA, the CPSC can issue performance requirements, warnings, instruction, or product bans if it finds that the product would create an “unreasonable risk of injury” when “no feasible consumer product safety standard,” including under the FHSA, can adequately address the risk.³⁸⁴ When the CPSC identifies a product as containing a hazardous substance, as part of the plan for addressing the hazards of the product, it may issue guidance on how to handle the product in a safe way. In some cases, this has included giving the public guidance as to the use of respiratory protection.³⁸⁵

The CPSC also has some authority regarding face masks and respirators when they qualify as “products” for regulation under the FHSA or the CPSA. For example, it applies labeling, testing, and certification requirements to consumer face masks, as well as flammability testing requirements.³⁸⁶ That said, it has disclaimed the authority to regulate either face masks that qualify as “medical devices”³⁸⁷ or N95 and P100 respirators.³⁸⁸ The CPSC does, however, consider consumer and children’s face masks to be apparel that is subject to flammability testing requirements.³⁸⁹ As a result, during the coronavirus pandemic, the primary impact of CPSC regulations on the approval, marketing, and postmarketing surveillance of respiratory protective products for the public relates to its consideration of consumers’ cloth face masks as apparel and (requiring compliance with flammability testing requirements of the Flammable Fabrics Act).

c. The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC)

NIOSH, within CDC, is empowered to “develop and establish recommended occupational safety and health standards.”³⁹⁰ As a result of their focus on occupational safety and health, NIOSH, and NPPTL nestled within it, have developed substantial research regarding PPE, and represent a substantial reservoir of expertise within the federal government regarding respiratory protection in particular.³⁹¹ That said, while NIOSH (and its associated agency OSHA) have sometimes partnered with other agencies (such as EPA) in addressing risks from inhalation hazards that apply both inside and outside workplaces,³⁹² neither NIOSH nor OSHA has the unilateral statutory authority to develop standards or to develop oversight programs for nonoccupational contexts.³⁹³

Though NIOSH/NPPTL’s authority is constrained to occupational safety and health, its expertise is often leveraged by other actors and has occasionally been used by Congress in specific public health emergencies. For example, NIOSH been granted special statutory authority to provide special programs to support health and safety research for World Trade Center

survivors (including members of the public).³⁹⁴ NIOSH/NPPTL expertise has also been used periodically for emergency-related tasks that benefit the public; for example, as described previously, during the pandemic, NPPTL staff conducted an assessment to determine the continued efficacy of respirators used beyond their designated shelf life.³⁹⁵

In addition, agencies with public health and safety authority routinely refer the public to NIOSH-set respirator standards, particularly NIOSH’s N95 respirator standard, even for respirator uses that are nonoccupational. For example, the CPSC recommends members of the public using hazardous arts and crafts products (in nonoccupational settings) use respirators certified by NIOSH/NPPTL³⁹⁶; FDA uses NIOSH’s N95 standards in its recommendations on respiratory protection for medical purposes³⁹⁷; CDC refers the public to NIOSH lists of approved respirators when giving guidance to members of the public about which respirators to wear³⁹⁸; and EPA recommends members of the public use a respirator certified as N95 by NIOSH/NPPTL against multiple hazards, including construction hazards,³⁹⁹ flood cleanup,⁴⁰⁰ and to protect against wildfire smoke.⁴⁰¹

Notably, although NIOSH/NPPTL certification standards are used routinely by other federal agencies in nonoccupational contexts, it is almost universally unclear how those

occupational standards are supposed to be transferred to nonoccupational contexts. NIOSH/NPPTL does not, for example, give direction to other agencies about how to transfer their occupational standards to public use. Nor do public safety and health agencies have a common practice of explaining the key considerations in such a transfer; agencies do not, for example, give guidance about how NIOSH/NPPTL standards should be adjusted for children (for whom there is clearly no occupational standard and for whom there are obvious concerns of fit). As a result, although occupational respiratory certification is frequently used to make recommendations for public respiratory use, such recommendations have an ad hoc character, and are not subject either to the guidance of any centralized authority, or to any apparent agency practice that would help to ensure such recommendations address important differences between occupational and nonoccupational applications.

d. Other authorities

This section discusses the role of other authorities—including other federal agencies, state and local authorities, and foreign authorities—in addressing oversight of respiratory protection for the public.

i. Federal authorities

The agencies discussed above appear to comprise the most important federal authorities regarding federal oversight of the development, approval, marketing, and/or postmarket surveillance of respiratory protection for the public. That said, other federal agencies have partial or occasional authority over various aspects of oversight of development, approval, marketing, and/or postmarketing surveillance. For example, the U.S. Immigrations and Customs Enforcement (ICE) and U.S. Customs and Border Protection (CPB), both components of the Department of Homeland Security, have seized counterfeit respirators during the COVID-19 pandemic,⁴⁰² and ICE has established an initiative (“Operation Stolen Promise”) to help keep counterfeit and substandard goods out of the medical and consumer supply chain.⁴⁰³

ii. State and local authorities

Generally speaking, states have authority to regulate development, approval, marketing, and/or postmarketing surveillance of public respiratory protection only where federal action has not precluded state action. States are precluded, for example, from engaging in oversight functions that would interfere with FDA’s oversight over respiratory protective devices that are used for medical purposes.⁴⁰⁴ Where there is no comprehensive federal scheme, however, states have substantial gap-filling authority.

As discussed above,⁴⁰⁵ state law also has a potential role to play through products liability for defective products. Another arena in which state law plays an indirect role in the oversight of respiratory protection is through another tort: fraud. State laws generally prohibit fraud, or a “knowing misrepresentation of the truth or of a material fact to induce another to act to his or her detriment.”⁴⁰⁶ Potential liability for fraud may incentivize honest marketing of products, including respiratory protection products available to the public. For example, in Colorado, the state attorney general secured a settlement with a company that had made misleading claims about the masks and respirators it sold during the COVID-19 pandemic.⁴⁰⁷

iii. Foreign authorities

Some respiratory protection that is marketed to the public is certified by foreign regulators rather than by federal or state authorities in the United States. For example, KN95 respirators, which have been approved for emergency medical use by FDA during the pandemic,⁴⁰⁸ are manufactured in China and are subject to Chinese regulatory control.⁴⁰⁹ The emergency exception for these respirators is administered by FDA, which also maintains a list of specific respirators that it identifies as reaching a sufficient filtration efficiency level.⁴¹⁰ One point worth noting is that because of the use of imported respiratory protection devices, particularly during the pandemic, this is an area in which foreign authorities can have an impact on the protection of the U.S. public.

e. Characterizing nonoccupational oversight

In sum, there is no single federal entity responsible for overseeing the development, approval, marketing, or postmarketing surveillance of respiratory protection for the public, or for generating or overseeing a certification program for managing these processes. The agency with the most significant authority is FDA, although its oversight authority is limited to respiratory protection used for “medical purposes.” Several other federal entities—including CDC and CPSC—serve some oversight function against specific respiratory hazards. Often, however, even these entities refer members of the public to NIOSH certifications, which were developed for occupational uses and for workers. Notably, there is no federal body—within CDC or elsewhere—responsible for creating respiratory protection certification programs for the public that would act as a corollary to the certification work done by NIOSH for occupational applications. This leaves substantial gaps in oversight for members of the public who seek to use

respirators outside of occupational-type contexts and for members of the public—most notably children—for whom there is no identifiable federal oversight at all.

PART II: POTENTIAL RECOMMENDATIONS AND THEIR IMPACTS ON THE REGULATORY LANDSCAPE

This part is intended to support the Committee as it crafts recommendations for new or revised laws or regulations regarding respiratory protection for the public and workers without respiratory protection programs (RPPs). In particular, it identifies possible actors and actions that the Committee could recommend to address gaps and help with managing overlaps, tailored to the reasons for those challenges in the regulatory landscape. The purposes of this section are to outline the range of potential recommendations and targets for recommendations by the Committee, and to support the Committee in addressing the institutional actors that have the legal authority to respond to the Committee’s recommendations.

This part of the paper provides a number of examples of potential recommendations that the Committee might make. At no point does the paper intend to advocate for or against the substance of any of these examples. Rather, the examples are presented as illustrations, and the goal in providing them is merely to help the Committee in understanding the legal and regulatory implications of various types of recommendations they might make, and to help the Committee in tailoring its recommendations to the legal authorities that are most likely to be empowered to respond.

Even more than the prior part of the paper, this part focuses on the federal regulatory landscape. Perhaps needless to say, directions regarding state law should be directed toward states. From a federal perspective, as a very basic matter, this part emphasizes the usefulness of making recommendations specifically to Congress to address statutory gaps, to the President in addressing problems of coordination and enforcement, and to agencies in addressing gaps and overlaps that come from regulatory interpretations.

A. Identifying Key Actors and Actions

Like most other modern democracies, the federal government of the United States is made up of three branches: the legislature (in the form of Congress), the executive (headed by the President), and the judiciary. The purpose and authority of each of these branches—as well as the basic framework for the sharing of authority between the federal government and the states—is set out in the U.S. Constitution.⁴¹¹

In addition to these three branches of government, the United States also relies heavily upon the authority of administrative agencies.⁴¹² Administrative agencies are units of government created by one of the branches of government—usually, though not always, Congress.⁴¹³ The powers of regulatory agencies are not set forth in the Constitution. Rather, agency authority is granted via statues enacted by Congress and/or executive actions taken by the

President, and constrained by review by the judiciary. The interconnected network created by administrative agencies, which are variously empowered to create, interpret, and enforce laws, and the branches that empower and constrain them, is commonly called the “regulatory state.”⁴¹⁴

As the Committee considers the implications of new or revised laws or regulations that may be considered to improve respiratory protection, it may be helpful to understand who has the authority to implement those recommendations, as well as how those recommendations are likely to operate within the regulatory state. Among the various actors to which the Committee may direct its recommendations, three—Congress, the President, and agencies—all have authority to choose to act in ways that affect the regulatory state and the ways in which the particular issue of respiratory protection is regulated. (Courts can also affect the operation of the regulatory state, though it is difficult to make meaningful recommendations directly to them, as their authority is limited to considering specific “cases” and “controversies” that come before them.⁴¹⁵ Their clearest role comes in reviewing the actions of agencies.⁴¹⁶ With this in mind, the remainder of this section outlines the authority of these key actors, describes the legal and regulatory tools that the Committee may choose to deploy in its final recommendations, and identifies some of the most important implications of selecting each tool. For a quick reference summarizing general areas of authority, key institutional strengths, and sample forms of action for Congress, the President, and agencies, please see Chart 1 below.

Chart 1: A Summary of Institutional Actors—Authority, Key Strengths, and Sample Forms of Action

B. Making Recommendations to Congress

This section addresses important types of recommendations that can be made to Congress. Such recommendations are particularly likely to be important where there are statutory gaps in authority or where the Committee believes that additional funding will be needed to implement its recommendations.

1. Features and Limitations of Congressional Action

This section presents a brief legal, procedural, and institutional orientation to congressional action and to legal constraints on Congress. The purpose of the section is to outline the basic procedures Congress uses to make law and the various functions Congress serves in empowering and controlling agency action.

The U.S. Congress is made up of two houses: the U.S. Senate and the House of Representatives. Congressional authority is set out in Article I of the Constitution.⁴¹⁷ Generally speaking, as the legislative branch of government, Congress is empowered to make law in the form of statutes. The legislative process for enacting statutes is long and relatively

complicated.⁴¹⁸ First, a bill must be sponsored. Once it is sponsored—in either house of Congress—it is assigned to a committee of representatives or senators. The congressional committee may amend the bill if they choose. The committee then votes either to accept the bill (in which case it is sent to the House or Senate floor for debate), reject the bill (in which case the bill dies), or send it to a subcommittee for further research (in which case it comes back, eventually, to the committee to accept or reject). If a bill reaches the House or Senate floor, it is then debated and members of Congress may propose changes or amendments before voting. If the majority vote to pass the bill, it moves to the other house to go through a similar process, proceeding through committees, debate, and voting. Both houses must then agree to the same version of the final bill, in a process called reconciliation, before the bill is passed to the President. The President may then choose to sign the bill—in which case the bill becomes law—or to veto.⁴¹⁹ Amendments to existing statutes require essentially the same process.⁴²⁰

This process is time-consuming and of course may involve political controversy. As a result, most bills never become statutes.⁴²¹

Another important aspect of congressional authority relates to appropriations. The responsibility for appropriations is technically shared between the President (who proposes an annual budget and has the opportunity to veto the final budget) and Congress.⁴²² In practice, however, Congress’s role in appropriations is particularly intense, and recommendations to increase (or decrease) the appropriations granted to a particular agency or division within an agency are generally addressed within Congress’s appropriations committees.⁴²³

2. Potential Types of Recommendations

This section identifies examples of the types of recommendations that would be most effectively directed toward Congress, rather than (only) agencies or the President. It identifies the types of recommendations that the Committee might make specifically to Congress, along with the basic procedural constraints and processes that would be required for each to occur, and gives several examples to illustrate the types of recommendations in which Congress would necessarily be involved. These examples are provided for purposes of clarification only and are not meant to advocate for or against any specific set of substantive recommendations by the Committee.

Generally, recommendations to Congress are a particularly good institutional fit when the remedy suggested would require a change to existing agencies or to those agencies’ statutory authority, or to the appropriations and other resources assigned to specific agencies.

The types of potential action that would implicate Congress’s authority, and which might therefore be best addressed to Congress, include:

• Passing a new statute giving authority to existing agencies
• Amending existing statute(s) to clarify or expand the authority of existing agency/ies
• Creating a new agency, empowered with new or existing authority
• Adjusting appropriations to existing agencies

For example, the current statutory landscape sharply distinguishes occupational and nonoccupational exposure to respiratory hazards. Under the Occupational Safety and Health Act (OSH Act), Congress has given specific authority to the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH) regarding the regulation of workplace safety (including inhalation hazards),⁴²⁴ without giving similar authority to either those agencies or other agencies regarding general public safety regarding inhalation hazards. While this distinction is currently a distinguishing feature of the regulatory landscape of respiratory protection, it is a feature that was created by Congress and which (only) Congress has the authority to change, whether by amending the OSH Act or passing a new statute. Similarly, only Congress has the authority to pass new legislation directed specifically toward the management of inhalation hazards.

Congress also has the authority to create a new agency via legislation. Most major agencies were created this way, although as noted in the subsequent section, a number of other agencies have been created unilaterally by the President.⁴²⁵ Agencies created by Congress tend to be better-funded and to exist for longer than those made unilaterally by the President,⁴²⁶ and to be less subject to presidential control.⁴²⁷

Smaller recommendations regarding the expansion or contraction of some agency’s authority would also be appropriately directed toward Congress. For example, Congress could expand the responsibilities of the National Advisory Committee on Occupational Safety and Health (NACOSH), restrict or explicate the authority of the Food and Drug Administration (FDA) in regards to regulating respirators for public use, or amend the OSH Act to expand who is protected as a “worker.”

Because of Congress’s power over appropriations, advice to increase the funding of a particular agency, such as the National Personal Protective Technology Laboratory (NPPTL), would reasonably be directed to Congress as well.

C. Making Recommendations to the President

This section provides background regarding important types of recommendations that the Committee might choose to make to the President. Such recommendations may be particularly

helpful in encouraging coordination across agencies and/or in addressing statutory or regulatory gaps.

1. Features and Limitations of Executive Action

This section provides a brief legal, procedural, and institutional orientation on executive action, and a quick overview of legal constraints on executive action. The purpose of the section is to clarify the basic procedures and actions the President has available for managing agency decisions and working within statutory gaps.

The powers of the President are set out in Article II of the Constitution.⁴²⁸ Generally speaking, the President is tasked with implementing and enforcing the law. As the head of the executive branch, the President has significant authority over the way that most agencies implement and enforce the statutes that they administer.⁴²⁹ For agencies within the executive branch, presidential authority is particularly robust; the President may, for example, fire the heads of executive agencies for any reason at any time, including because the President dislikes the agency’s implementation of the President’s policy priorities.⁴³⁰ Independent agencies, created by Congress outside the executive branch, have some insulation from presidential oversight—most notably, the heads of independent agencies are not removable by the President at will⁴³¹—though they remain subject to some limited forms of executive authority.⁴³²

As chief executive, the President has a number of mechanisms for centralizing executive review of agency action⁴³³ and for encouraging cross-agency cooperation, including by issuing executive orders directing cooperation and/or prioritizing management of respiratory hazards, creating interagency working groups, and/or elaborating or amending existing presidential plans, such as the COVID-19 response plan.⁴³⁴ These functions can be used to coordinate multiple agencies, particularly where there are overlaps in existing authority of those agencies.

Presidents also have the authority to direct creation of a new agency, and in fact they have done so many times over the past decades.⁴³⁵ Two limitations on this authority are worth noting, however. First, while Presidents have the authority to direct creation of executive agencies, which are then subject to direct executive control, Congress also has the power to restrict unilateral presidential action in this realm through their power over appropriations.⁴³⁶ If the President were to create an agency that Congress disapproved of, Congress could use the power of the purse to starve the agency of public resources.⁴³⁷ Second, actions that can be unilaterally performed by one President can be unilaterally reversed by a subsequent

President.⁴³⁸ As a result, using executive power to create an agency leaves that agency vulnerable to executive abolishment.⁴³⁹ Presidents have no such unilateral power to abolish agencies that are instead created by Congress.

As the head of the executive branch, the President has wide-ranging powers related to the execution of the law. Presidents implement their enforcement and executive authority with a variety of tools, including with executive orders and plans. These help articulate the policy preferences of the President and to direct the remainder of the executive branch in implementing those preferences. While Presidents do not have the authority to direct agencies or other actors to contravene the Constitution, and only rarely have the authority to direct them to violate existing statutes, this still leaves substantial executive discretion.⁴⁴⁰

2. Potential Types of Recommendations

This section will identify the types of recommendations that might be made to the President, along with the constraints and processes that would be required for each to occur. Recommendation types that might be considered include:

• Elaborating on or amending existing presidential plans, such as the COVID-19 response plan
• Encouraging coordination across agencies
• Issuing new executive orders
• Directing creation of a new agency
• Repealing, expanding, or amending existing executive orders
• Issuing emergency designations or funding

Where the Committee believes existing agencies already have sufficient authority to manage respiratory protection but believes that additional coordination would be valuable, it would be reasonable to direct recommendations on coordination to the President, rather than to (only) the individual agencies. The President has the authority to coordinate across agencies, to prioritize agency actions, and even to direct agencies to shift their interpretations of the statutes they administer (so long as those interpretations remain reasonable and within the bounds of what Congress has allowed).

General policy priorities can also be reasonably directed to the President, who has multiple mechanisms for executing those policies. Such priorities could be directed either toward improving respiratory protection in general, as with the creation of an interagency working group directed toward improving and coordinating provision and development of respiratory protection for the public, or could address particular respiratory hazards.

In regards to particular respiratory hazards, the President has significant authority in issuing specific plans and orders, particularly when directed toward emergencies such as the

COVID-19 pandemic.⁴⁴¹ The Committee could, for example, recommend amendments or details furthering the goals of the existing COVID-19 response plan by providing for additional respiratory protection for the public. The “National Strategy for the COVID-19 Response and Pandemic Preparedness” already includes, for instance, a goal to “[m]itigate spread through expanding masking, testing, treatment, data, workforce, and clear public health standards,”⁴⁴² and seeks “to implement a cohesive strategy to significantly reduce the spread of COVID-19 and release clear public health guidance to the public about what to do and when, including implementing mask mandates,” as well as other methods.⁴⁴³ Recommendations on how to further detail these recommendations to address respiratory protection as the Committee understands it would be reasonably addressed to the President, who obviously would have the authority to implement those recommendations under the plan if he or she so chose. Similarly, the Committee might make recommendations directly to the President about the best type of respiratory protection to require in instances where the executive has authority to mandate use of masks or respiratory protection. The President has, for example, required mask-wearing on modes of public transportation that are regulated by federal agencies, including airplanes, trains, and public maritime vessels,⁴⁴⁴ and in federal workplaces.⁴⁴⁵ The President has also directed multiple agencies to assess the availability of federal research grants “to study best practices for implementing, and innovations to better implement, effective mask-wearing and physical distancing policies, with respect to both the Federal workforce and the general public.”⁴⁴⁶ The Committee’s recommendations may help to inform implementation of these existing orders—for example, by clarifying the type of mask-wearing and/or respiratory protection that is most effective. Any recommendations to change or amend existing executive orders would also need to be addressed to the President.

D. Making Recommendations to Agencies

This section provides background regarding important types of recommendations that the Committee may choose to make to agencies. Such recommendations may be particularly important where gaps or overlaps have arisen as a result of agency action and/or where there are gaps or overlaps that may be addressed by additional agency coordination.

1. Features and Limitations of Agency Action

This section will include a brief legal, procedural, and institutional orientation on agency action and legal constraints on agency action. The purpose of the section is to clarify the basic procedures and actions agencies use to make, enforce, and interpret laws and regulations.

The powers of regulatory agencies are not set out in the Constitution. Rather, agency authority comes from the other branches—specifically, from Congress and the President. All three branches of the government have ways of checking (or changing) agency action. Congress has the power to change the statutory directions that empower the agency and thus to change the agency’s obligations and room for discretion, and has significant control over agency appropriations.⁴⁴⁷ Presidents affect agency decisions via executive orders and directions regarding the enforcement of an agency’s duties, via centralized review and coordination of agency action, and in the case of executive agencies, via control over agency personnel (most notably, with the power to fire the heads of executive agencies for any reason, including disagreement over a particular regulation).⁴⁴⁸ Courts affect agency actions via judicial review, which is most commonly directed toward ensuring that an agency has not exceeded its statutory authority, has used appropriate procedure, and/or that the agency has not acted arbitrarily.⁴⁴⁹

Agencies do not have Constitutional authority of their own and may never act beyond the authority that has been granted them by law.⁴⁵⁰ Where statutes are ambiguous or leave gaps, however, agencies are typically granted broad discretion to interpret the statutes they administer, so long as their interpretations are reasonable and do not fly in the face of congressional direction.⁴⁵¹ Because of this—and despite the forms of control otherwise imposed by Congress, the President, and courts—agencies often have significant leeway in determining the policy choices that they believe to be best. Committee recommendations directed toward agencies can therefore have important power to persuade among varying permissible interpretations.

Agencies have several types of action they may take to further their statutory obligations and generally enjoy broad discretion in choosing between these forms.⁴⁵² Some of these types of action—namely, rulemaking and adjudication—create legally binding requirements and come along with procedural requirements that agencies must follow or risk having the action overturned in court.⁴⁵³ Agencies also take a number of actions that do not create legally

enforceable requirements—but which the agency believes otherwise promote its statutory obligations. Agency actions that are not legally enforceable are generally characterized as “guidance,” and includes things like interpretive rules, general statements of policy, memoranda, manuals, bulletins, and advisories.⁴⁵⁴ They also include some forms of interagency cooperation, such as those imbedded in interagency memoranda of cooperation.⁴⁵⁵ Because guidance is not legally enforceable, courts will often not review it⁴⁵⁶; when they do, however, they generally apply a less deferential standard of review.⁴⁵⁷ As a result, while guidance is less likely to be reviewed by a court than are legally binding rulemaking or adjudication, any review by a court is somewhat more likely to overturn guidance that is reviewed.

As discussed further above, Presidents exert significant oversight of agency policy. This includes some executive oversight of guidance, particularly “significant” guidance,⁴⁵⁸ and agencies are also subject to general executive-branch guidance meant to encourage good guidance policies, as well as to centralized executive review of guidance documents (and heightened review of “significant” guidance).⁴⁵⁹

Notably, recommendations to agencies by the National Academies can have particularly significant legal implications not only in potentially persuading an agency to use its discretion to act,⁴⁶⁰ but also in the event that agency action is challenged in court.⁴⁶¹ Specifically, while agencies have substantial authority in setting their own priorities and in interpreting statutes they administer, courts will overturn agency actions if they are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”⁴⁶² As the Supreme Court has explained, “[n]ormally, an agency rule would be arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.”⁴⁶³ National Academies recommendations can particularly affect whether courts view agencies as having failed to consider an important aspect of a problem or to have addressed the evidence before the agency.⁴⁶⁴ In this sense, recommendations that comment on an important aspect of a problem that an agency needs to address, or that characterize existing evidence, can also be understood as particularly relevant to agency action and thus to the agencies that may read the Committee’s report.

2. Potential Types of Recommendations

This section identifies examples of the types of recommendations that would be most effectively directed toward agencies, rather than (only) Congress or the President. It identifies the types of recommendations that the Committee might direct toward agencies, along with the basic procedural constraints and processes that would be required for each to occur. It also gives several examples to illustrate the types of recommendations in which agencies would presumably

be involved. Once again, these examples are provided for purposes of clarification only and are not meant to advocate for or against any specific set of substantive recommendations by the Committee.

Generally, recommendations to agencies are a particularly good institutional fit when the remedy suggested falls within agency discretion. This includes matters that would require a change to an agency’s existing interpretation of its own authority under a statute, or a change to the agency to issue a new regulation or guidance under its existing authority, or a shift in its own internal resource allocation.

Types of potential action that would implicate agency action, and that might therefore be best addressed to one or several agencies, include:

• Revisiting an existing interpretation of statutory authority, whether more expansively (to increase opportunity for requirements) or less expansively (to get out of the way of another agency)
• Issuing new regulations under existing statutory interpretations
• Providing additional guidance for voluntary recommendations, education, risk communication, etc.
• Shifting resource allocation (e.g., by devoting additional resources to inhalation hazards or respiratory protection)
• Coordinating with other agencies

For example, a recommendation that the Environmental Protection Agency (EPA) revisit its existing interpretations of statutes, such as the Toxic Substances Control Act and the Clean Air Act, to adopt the broadest permissible interpretations of its statutory authority to protect the public from inhalation hazards could be reasonably addressed to EPA rather than Congress. As noted above, EPA has substantial discretion in interpreting statutes it administers,⁴⁶⁵ and so long as the agency’s interpretations are not precluded by statute, this would be an example of a way in which agency discretion can substantially affect the regulatory landscape of respiratory protection. While Presidents may also make such recommendations—as noted in the prior section—agencies have substantial authority to adopt such interpretations of statutes they administer, even without specific presidential involvement.

Recommendations that agencies reconsider specific facts regarding inhalation hazards, and act under their existing regulations addressing those hazards, would also be reasonably addressed toward agencies. For example, a recommendation that the Occupational Safety and Health Administration (OSHA) revisit its presumption that workplaces without respiratory protection programs present no significant risk of workplace injury, either generally or specifically during a respiratory pandemic, could be addressed specifically to OSHA.

Agencies also have substantial discretion in setting their own priorities and to some extent in allocating resources within the agency. On this front, a recommendation that an agency or agencies, such as EPA, prioritize inhalation hazards as among its other statutory responsibilities, could also reasonably be addressed to the agency specifically.

By contrast, it is not helpful to make recommendations to agencies to expand their actions to address issues beyond their statutory authority. In some cases, the lack of statutory authority is clear. OSHA, for example, does not have the statutory authority to directly regulate

state and local government workplaces, or to set safety standards outside the workplace. If the Committee believed that either of those limitations was inappropriate or unwise, it would have to address Congress to change the statute.

In some cases, it can be difficult to tell the far extent of an agency’s statutory authority, and agencies may sometimes have adopted narrow interpretations without even recognizing that they have broader authority. EPA, for example, might believe that it is precluded under the Clean Air Act from regulating indoor respiratory hazards. If an agency believes (whether accurately or inaccurately) that it is statutorily precluded from an interpretation the Committee prefers, the Committee would do better to address its recommendations either to the President (who has the authority to direct executive agencies to take the preferred interpretation, so long as it is in fact permitted by statute) or to Congress (if the statute in fact precludes the preferred interpretation).

CONCLUSION

This background paper has described the current regulatory landscape of respiratory protection in the United States, looking at the way respiratory protection is regulated in the workplace (especially for workers without respiratory protection programs) and for the public. As it has detailed, the regulation of respiratory protection in the United States is highly fragmented, involving multiple actors at the federal and subfederal levels, which have varying responsibilities and authority regarding different aspects of different respiratory hazards.

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