Summary¹

Recent disasters—including the COVID-19 pandemic and the devastating wildfires recurring annually in the western United States—have highlighted major gaps in the nation’s system for ensuring timely access to and guidance on appropriate respiratory protection² for the public and for many workers. The enormity of the scale of these events, with a reach extending across the entire nation, and the magnitude of their impacts on public health have underscored the need to take action now to close these gaps and meet the respiratory protection needs of the public and all workers. Recognizing this imperative, three federal sponsors (the National Institute for Occupational Safety and Health [NIOSH], the Environmental Protection Agency [EPA], and the Department of State) and the CDC Foundation requested that the National Academies of Sciences, Engineering, and Medicine convene an ad hoc committee of experts to formulate recommendations for a framework of responsibilities and authorities that would provide a unified and authoritative source of information and effective oversight for the development, approval, and use of respiratory protection.³ To inform the development of its framework, the committee was also charged with determining the need for guidance on respiratory protection

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¹ This Summary does not include references. Citations for the discussion presented in the Summary appear in the subsequent report chapters.

² Respiratory protection broadly describes any approach designed to reduce exposure to hazards that can be inhaled (i.e., inhalation hazards).

³ During early meetings, the study sponsors clarified that the focus of the study was not limited to respirators but also included other devices, such as barrier face coverings, face coverings, and masks, which are defined in the following section.

for the public and workers without respiratory protection programs (RPPs) based on an assessment of existing knowledge regarding factors necessary to ensure that respiratory protection is effective for its intended use, as well as gaps in existing standards and guidance. The full charge to the committee is presented in Chapter 1 of this report.

As a result of the ongoing COVID-19 pandemic and widely visible wildfire smoke, often at levels exceeding the National Ambient Air Quality Standards for particulate matter, the public has become increasingly aware of various devices intended for use in reducing the adverse effects of inhalation hazards. Nonetheless, much of the technical terminology used in this area—such as “respiratory protection” and the distinctions among masks, face coverings, and respirators—is unfamiliar to the public. Box S-1 defines

key terminology used in this report and a more detailed terminology discussion can be found in Chapter 1.

CURRENT SYSTEMS FOR RESPIRATORY PROTECTION: GAPS AND CHALLENGES

Historically, the use of respiratory protection in the United States has been associated with occupational settings where workers are exposed to defined inhalation hazards—for example, health care workers exposed to tuberculosis, structural firefighters exposed to smoke, and miners exposed to coal dust and silica. The United States has an employer-based approach to respiratory protection whereby employers are required to ensure that

their workplaces are safe and their employees are protected from hazards, including inhalation hazards; compliance with this requirement is overseen primarily by the Occupational Safety and Health Administration (OSHA). The spectrum of approaches taken to limit exposures is referred to as the hierarchy of controls, which prioritizes removal of the sources of hazards and identifies personal protective equipment as a final line of defense when other, higher-level controls are not fully protective. In the context of an epidemic caused by an airborne infectious agent, for example, vaccination would represent an important form of control.

In workplaces where more effective measures—those higher in the hierarchy of controls, such as substitution or engineering controls—are insufficient to reduce hazardous exposures and respirators are therefore necessary to protect the health of employees, employers are required by OSHA, or by other federal or state agencies with oversight authorities for specific populations or hazards, to establish an RPP. The RPP guides the selection and the safe and effective use of respirators—specifically, those that have been approved by NIOSH following a conformity assessment process that is overseen by NIOSH’s National Personal Protective Technology Laboratory (NPPTL) and demonstrates that the devices meet preestablished standards and provide the defined level of respiratory protection. To comply with OSHA’s Respiratory Protection Standard, employers are required to provide all employees covered by the RPP with respirators that are appropriate for the intended purpose and fitted (where tight-fitting respirators are used) to each individual employee, along with training and medical evaluations, at no cost to the worker.

These interconnected systems for approving respiratory protective devices for use in workplace RPPs and for generating requirements and guidance on their use are grounded in the science of exposure assessment and understanding of the risks posed by specific hazards. While exposure limits may be lacking for some workplace inhalation hazards, data can generally be collected with regard to concentrations and durations of exposures. In the context of an RPP, the risks of these workplace exposures can reasonably be predicted, and performance requirements for respiratory protection can be established and translated into standards. In contrast, the United States has no coordinated system supporting the development of standards and guidance for respiratory protection for workers outside of an RPP or for the public. For these populations—which are diverse and varying in demographic characteristics, vulnerability,⁴ and susceptibility—the agents of concern and the circumstances of exposure are broad, encompassing

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⁴ The committee defines vulnerability as individuals’ likelihood of being exposed to a hazard because of who they are and where they work, study, play, or live. This concept is distinct from susceptibility, which is defined as an individual’s risk for harm when exposed to a particular hazard.

both acute emergency scenarios and ongoing or more routine exposures. The exposures and risks for these populations are often difficult to fully quantify. The current system also creates siloes and does not recognize that workers with specific exposures are also members of the public with other exposures. As such, the regulatory landscape for these populations is highly fragmented, with notable gaps in authorities, and there is no cohesive national strategy for addressing their respiratory protection needs. As a result, the needs of many workers and the public for adequate respiratory protection are not being met, and significant disparities exist. It is essential, moreover, that efforts to address respiratory protection more comprehensively acknowledge and address the needs of those who are most vulnerable, including but not limited to those who live in underresourced communities; those in low-paying positions; people with disabilities; those with limited English proficiency; workers who cannot work remotely; and gig workers, migrant workers, day laborers, and other workers for whom there is little paperwork to track their movements.

Gaps and Challenges for Workers

The regulatory system for workplace respiratory protection is focused primarily on occupational settings with well-defined hazards and clear employer–employee relationships. While this system, properly implemented, should provide respiratory protection for workers covered by RPPs, large numbers of workers remain exposed to inhalation hazards that increase their risk of illness but are not covered by these OSHA-mandated programs. Such incomplete coverage may occur either when employers covered by OSHA (i.e., workplaces where OSHA is a governing authority and to which OSHA regulations apply) fail to comply with RPP requirements or when workers are excluded from OSHA coverage.

There are several reasons for these gaps in coverage. OSHA standards, including the RPP requirements and standards limiting workplace exposure to hazardous substances, are applicable only to employers covered under provisions of the Occupational Safety and Health (OSH) Act of 1970, which created OSHA. From its inception, OSHA did not cover all workers and workplaces. Excluded from OSHA coverage, for example, are state and local government workers in states whose private-sector employers are under the authority of federal OSHA.⁵ Furthermore, a long-standing congres-

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⁵ Many states and some U.S. territories administer their own occupational safety and health programs via OSHA-approved State Plans, which must meet baseline federal OSHA safety standards. In places with State Plans, workers—including state and local government workers—are supposed to have protections “at least as effective” as OSHA standards regarding inhalation hazards in the workplace. State and local government workers in 24 states and the District of Columbia, the Northern Mariana Islands, Guam, and American Samoa are not covered by OSHA standards or by OSHA-approved State Plans.

sional appropriations provision prohibits OSHA from any involvement in farms with 10 or fewer workers. Additional gaps in coverage have resulted from changing work practices in the United States and OSHA’s interpretation of the OSH Act: currently, independent contractors, self-employed workers, and gig workers are not considered employees of an employer and are therefore not covered by OSHA requirements. Furthermore, the misclassification of some workers as self-employed when specific labor requirements for that designation have not been met increases the number of workers who remain outside of OSHA jurisdiction.

Further challenges stem from workplace exposures to inhalation hazards that arise in the context of public health and environmental emergencies, such as infectious disease outbreaks and wildfires. Relevant examples include agricultural and other outdoor workers exposed to wildfire smoke, as well as workers who are at increased risk of exposure to SARS-CoV-2, the virus responsible for COVID-19, as a result of their interactions with the public, clients, patients, customers, and other workers. Because these hazards are not typically encountered by workers outside of emergency situations (i.e., in the normal course of work), their employers may not have instituted an RPP.

While workers not covered by workplace RPPs may still have access to NIOSH-approved respirators through the commercial marketplace, such devices are approved on the assumption that they will be used in the context of an RPP. In the absence of an appropriate hazard assessment, fit testing, medical clearance, training, and other RPP components, the protection afforded to workers by such devices may be diminished.

Gaps and Challenges for the Public

While OSHA and NIOSH have primary oversight for respiratory protection in the United States, their authorities are limited to occupational settings; there is no central authority responsible for respiratory protection of the public. In the absence of comprehensive federal regulation, significant authority regarding the use of respiratory protective devices by the public is left to the states. Although the states may receive guidance from federal agencies, there is no formal system for coordinating the development and distribution of such guidance to state and local health agencies or the public. The situation is even more complex with respect to U.S. government workers and their families stationed in foreign countries that have high levels of air pollution.

The landscape of devices used by the public with the intent of reducing exposure to inhalation hazards includes NIOSH-approved respirators; surgical/medical masks designed for workplace use, some of which are cleared by the Food and Drug Administration; respirators marketed as approved

in other countries (e.g., KN95); and products (e.g., face coverings) that are not intended to be used as respiratory protective devices in the workplace and thus are currently subject to no certifying body or formal oversight designed to ensure that the devices are effective for their intended use. The lack of a comprehensive regulatory framework makes it difficult to understand the level of protection provided by a product against a known or unknown inhalation hazard, especially given the challenges of ensuring proper fit for individuals across a population with considerable physical and demographic heterogeneity and the sociobehavioral considerations that impact access to and effective use of a device (e.g., attitudes and beliefs, safety culture).

The elements of the occupational respiratory protection model, including the fundamental program components of hazard assessment to guide respirator selection, medical clearance, regular fit testing, and user training, are not easily scalable to or suitable for application to the use of respiratory protection by the public. For the public, then, a new paradigm is needed that is directed at reducing both population harm and individual risk and supports particularly vulnerable groups, including those with limited autonomy to access protection. Such a paradigm must also consider the emerging social and political factors that contribute to resistance to the use of respiratory protective devices in certain subpopulations.

A GENERAL FRAMEWORK FOR OVERSIGHT AND GUIDANCE TO MEET RESPIRATORY PROTECTION NEEDS

In response to its charge, the committee used a systems approach to develop a general framework to be applied to both workers and the general population. Figure S-1 depicts the functional elements of this framework. Several foundational principles guided the framework’s development. Foremost among these is the primacy of primary prevention of exposure to inhalation hazards for all. Equity is an overarching principle that should underpin the framework, recognizing the heterogeneity of the populations needing functional and acceptable respiratory protection across multiple dimensions, including age, racial and ethnic background, variation in facial profiles, underlying health and disease status, presence of a disability, level of education, income, language, and geographic location, among others. Moreover, while respiratory protective devices may be necessary to protect against such hazards when elimination and engineering, administrative, and other controls are not feasible or available, efforts should first be made to control exposure sources. Furthermore, all stakeholders—including federal, state, local, tribal, and territorial government agencies; employers; manufacturers; standards development organizations; and individuals—need to understand that respiratory protection does not confer absolute protection.

Nonetheless, although some level of risk remains even with use of available devices, respiratory protection decreases the risk for harms to health from inhalation hazards, and when details of a hazard are known, appropriate respiratory protection should decrease risk to a level considered acceptable based on structured evaluation of the risk. When information is incomplete and rapidly evolving, however, decisions will need to be made in the face of uncertainty.

The committee’s systems approach to developing its general framework was designed to incorporate the many elements necessary to ensure effective respiratory protection (e.g., hazard identification and assessment, product design and manufacturing, device selection and use) for a wide range of stakeholders and reflects the relationships among those elements. Central

to this approach was recognition of the need for an entity accountable for coordination of efforts and the incorporation of multiple feedback loops across the elements to ensure ongoing improvement in the diverse functions encompassed by the framework (see Figure S-1). Moreover, the framework would need to focus not just on response to specific incidents but also on preparedness at all levels to prevent failures during emergencies and other times of acute need or stress.

The resulting foundational construct incorporates the seven core functions depicted in Figure S-1 and described in Box S-2. Each function comprises specific subfunctions, which may be ongoing or triggered by the occurrence of a specific hazard. In the context of respiratory protection needs for emergencies, the ongoing subfunctions represent critical aspects of national preparedness. It should be noted that while the functions are ordered for purposes of describing the framework, this structure is not intended to imply a specific sequence in which they must occur; rather, the functions are dynamic, and their sequencing will be determined by the specific exposure situation, with some occurring simultaneously. Use of the term “respiratory protective device” in the function titles makes clear that the general framework includes the functions of both personal inhalation protection and source control. It is important to note as well that the framework is intended to evolve and be sustained over time, and to be agile in anticipating and responding to new threats that may emerge in the future.

After developing the general framework detailed above, the committee applied that framework’s functions in developing two specific frameworks: one focused on meeting the respiratory protection needs of workers without RPPs, and one on meeting the respiratory protection needs of the public. The committee’s recommendations for applying the functions of its general framework to these two populations are presented in the following sections.

The core functions of the frameworks for these populations are comparable, as reflected in the parallel structures for the sections that follow. For workers, several components of the existing system for occupational respiratory protection correspond to the committee’s proposed general framework, but as described above, respiratory protection for workers not covered by RPPs is a notable gap. To address this gap, the committee considers that the current system featuring strong central roles for OSHA and NIOSH could function more broadly. For the public, the current landscape of respiratory protection is substantially more complicated to address, characterized by considerable fragmentation across multiple federal and subfederal stakeholders and many gaps in authorities. As a result, it has been necessary to rely on ad hoc structures and processes to fill gaps in respiratory protection needs in emergency settings. A framework for the public needs to provide a formalized structure that addresses both authority gaps and critical coordination needs.

APPLYING THE COMMITTEE’S GENERAL FRAMEWORK TO MEET THE RESPIRATORY PROTECTION NEEDS OF WORKERS WITHOUT RESPIRATORY PROTECTION PROGRAMS

Ensuring Adequate Coordination (Function F6) and Authorities to Protect Workers from Inhalation Hazards

As described above, the current system for respiratory protection for workers involves interactions among multiple parties in the private sector and is shaped by the regulatory activities of federal agencies, particularly NIOSH and OSHA. In recognition of its current authority in the realm of worker health and safety, the committee identifies OSHA as the appropriate

coordinating entity for the development, functioning, oversight, evaluation, and continuous improvement of its proposed framework for ensuring that workers not currently covered by RPPs are adequately protected from inhalation hazards. In its role as coordinating entity, OSHA, in partnership with NIOSH, would need to consult with other federal agencies as well as state and local agencies, as appropriate, when those agencies have regulatory authority over employers or are charged with recommending workplace health protections.

OSHA’s failure to meet the respiratory protection needs of all workers has, in part, resulted from the constrained application of its Respiratory Protection Standard as a result of outdated statutory interpretations that

limit the applicability of the standard to workers in traditional employer–employee relationships and from statutory language that displaces OSHA’s authority when occupational safety and health are regulated by another government agency. The following two recommendations are intended to address the significant gaps in OSHA coverage that prevent the agency from requiring that employers provide respiratory protection for many millions of workers not currently covered by an OSHA-compliant RPP.

Although Congress has made minor changes to the OSH Act in the 51 years since its enactment, there have been no substantive changes such as those the committee is recommending. The committee understands that there are difficulties involved in taking what may be considered a radical step and that doing so has broader implications beyond respiratory protection for inhalation hazards; however, the evolving nature of the workforce and the hazards it faces, together with the identified gaps in coverage of workers under the current OSH Act, calls for such change. Attempts to close these gaps through administrative means would be difficult and potentially temporary (i.e., subject to reversion to a narrower interpretation) absent a statutory redefinition of OSHA’s authority. Moreover, revision of the OSH Act would not address gaps in protection for state and local public-sector workers; action by state governments is needed to ensure respiratory protection for these workers.

Developing and Approving Respiratory Protective Devices (Function F0)

As the oversight entity for respirator conformity assessment in the United States, NIOSH is responsible for product testing in its laboratories, specifically those of NPPTL; no alternative laboratories are available should there be a disruption caused by a malfunction of equipment or a problem with the facility (e.g., due to a flood or fire). The requirement for NIOSH testing of respirators contributes to delays in the approval process and may make it difficult to respond to emergency situations because of capacity limitations. Third-party laboratory testing could improve surge capacity for respirator testing and enable NIOSH to meet expanded needs for respiratory protection for new groups of workers.

NIOSH also faces delays in advancing necessary standards for respirator testing. Because such standards are contained in regulation, the establishment of new standards or revision of current standards is subject to lengthy rulemaking processes, including publication in the Federal Register and solicitation and receipt of public comments. To ensure that Function F0 is optimized, the committee makes the following recommendation:

As with the current system, the committee envisions that NIOSH would continue to oversee conformity assessment, and respirators tested by third-party organizations would still require NIOSH approval to be used in OSHA-compliant RPPs. Additional appropriated funding from Congress will be necessary for the expansion of NIOSH/NPPTL’s respirator approval program to meet the needs of a broader group of workers.

Assessing Hazards and Determining the Need for Respiratory Protection (Function F1)

Under the current system, employers are required to determine the need for respiratory protection for their employees, and employers must adhere to any standards issued by OSHA (or other agencies with regulatory

authorities, such as the EPA and the Mine Safety and Health Administration [MSHA]). Employers are obligated to initiate an RPP only if they conduct an assessment and determine that an RPP is necessary. Most workers are not covered by an RPP or by mandatory workplace safety standards addressing the use of respiratory protection. Yet recent experiences with worsening and novel, unanticipated threats, such as wildfire smoke and SARS-CoV-2, point to the potential need to introduce respiratory protection measures at an expanded number of worksites when inhalation hazards exist and other control measures are not feasible. The absence of an OSHA standard for airborne infectious disease agents and the outdated nature of the existing standard for particulate matter (PM), as discussed further below, impede efforts to systematically institute respiratory protection measures when workers are exposed to such hazards. One approach to addressing this gap is for OSHA to modify its respiratory protection regulations to expand the types of exposures and circumstances in which workers in establishments that fall under its authority are enrolled in RPPs. OSHA has both the statutory authority to implement new RPP requirements when inhalation hazards pose a “significant risk”⁶ to workers covered by OSHA—even if these risks are periodic in nature—and the expertise to guide employers in implementing these requirements.

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⁶ OSHA is authorized to promulgate health and safety standards in the workplace only after it has satisfied the need for a threshold finding that “a significant risk” of material health impairment exists. This requirement flows from an influential Supreme Court case, Industrial Union Department v. American Petroleum Institute (generally referred to as the “Benzene decision”).

OSHA currently covers exposure to particulate matter that is not included in hazard-specific standards, such as that for crystalline silica, through the Permissible Exposure Limit (PEL) for Particulates Not Otherwise Regulated (PNOR), also known as the “nuisance dust” standard. The PNOR PEL averaged over 8 hours is 15 mg/m³ (measured as total particulate) and 5 mg/m³ (measured as the respirable fraction). Of note, the 24-hour National Ambient Air Quality Standard for fine particulate matter (PM_2.5) of 35 µg/m³ is orders of magnitude less than the PNOR PEL. OSHA’s PNOR PEL far exceeds levels the EPA considers hazardous to human health on the Air Quality Index and levels shown to result in increased morbidity and mortality during wildfire smoke events. As it currently stands, the PNOR PEL does not provide adequate protection for workers exposed to wildfire smoke. Accordingly, in Recommendation 6-4, the committee proposes that OSHA issue a new evidence-based particulate matter standard with more health-relevant indicators and greater protection to replace the legacy standard of 5 mg/m³ for particulate matter.

While Recommendation 6-4 focuses on particulate matter and airborne infectious disease agents as high-priority targets for comprehensive exposure standards, the committee recognizes that standards for many other inhalation hazards faced by workers are outdated or lacking. Protecting workers without RPPs from inhalation hazards will require a more expansive effort to establish or update workplace exposure standards. Given the scope of such an effort, OSHA will need to explore creative approaches to undertaking it effectively and efficiently and, where feasible, without regulation. Given the challenges involved in implementing such approaches, consideration could be given to the potential application of modern technologies and advances in qualitative methods, such as control banding, that have been incorporated into regulatory systems outside the United States and provide an alternative to establishing quantitative exposure limits and standard setting on a contaminant-by-contaminant basis.

Determining the Necessary Respiratory Protective Devices (Function F2)

Under the committee’s proposed framework for worker protection, employers, following any relevant OSHA standards and regulations, would be responsible for determining which approved respirators should be used by workers exposed to particular hazards and under what circumstances. This determination would need to be based on completed or ongoing hazard assessments, taking into account the specific characteristics of the exposures

and workplaces, as well as the exposed workers. Based on its review of the literature on the performance of respiratory protective devices, the committee believes the filtration and fit characteristics of face coverings and masks currently do not adequately protect workers facing inhalation hazards. Therefore, in the context of workplace exposures to inhalation hazards, recommendations regarding the use of face coverings (including barrier face coverings) and masks should be avoided, and employers should be advised to institute an RPP and provide employees with respirators as described by OSHA’s Respiratory Protection Standard (1910.134).

Ensuring Availability and Access Pathways for Respiratory Protective Devices (Function F3)

The COVID-19 pandemic exposed severe limitations in existing supply chains for all forms of respirators, contributing to a lack of adequate protection for many workers. While the nation does have a system for stockpiling respirators, surgical/medical masks, and other materials needed for pandemic response, this system has proved inadequate to meet the needs for respiratory protective devices during the pandemic. The Strategic National Stockpile (SNS) was designed to supplement state and local jurisdictions during emergencies, but given its resource limitations and the inevitable delays associated with distribution of stockpiled materials, employers whose workers require respiratory protection, including health care and long-term care institutions, need to ensure ongoing access to sufficient stocks of those devices to meet worker needs, with consideration of storage requirements.

Expansion of OSHA respiratory protection requirements to a much broader population of workers (Recommendations 6-1 and 6-4) would likely bring new challenges to the task of ensuring adequate availability of and access to respirators, particularly during such large-scale events as a pandemic. This broader group of workers may have needs that differ from

those of workers traditionally covered by OSHA-mandated RPPs. For example, beyond the obvious issue of scale, the timing of their need for respiratory protection may be more unpredictable. Under the committee’s proposed framework, OSHA would need to work closely with employers, recommending appropriate quantities and characteristics of respirators to stock, to ensure that workplaces would not experience shortages during future emergencies. OSHA and NIOSH would also need to collaborate with federal authorities responsible for the supply chain to aid in understanding the potential scope of respiratory protection needs for workers during a large-scale incident involving inhalation hazards.

Engaging, Informing, and Ensuring Access for the Target Community (Function F4)

OSHA and MSHA, along with NIOSH, other units within the Centers for Disease Control and Prevention (CDC), and other federal agencies (e.g., EPA, the National Institute of Environmental Health Sciences [NIEHS]), produce and disseminate guidelines and other materials related to respiratory protection, written primarily for employers, worker organizations, and workers. However, this broad information, often distributed through government websites, may not be adequately accessible to the diverse workers who may need to use respirators for protection from inhalation hazards or address the multitude of psychosocial factors that impact choices and practices related to respiratory protection for these populations. To fill this gap, a number of labor, academic, and nonprofit groups have created materials designed and tailored for specific worker populations. However, such efforts are fragmented and ad hoc. Expanded efforts by OSHA, NIOSH, and other relevant federal agencies are needed to ensure that guidance and training on the use of respiratory protection meet the needs of workers, particularly those who may be incidentally exposed to inhalation hazards

while performing their work (i.e., those whose work itself generally does not pose a threat from inhalation hazards but may do so in certain situations, such as wildfires) and whose employers have not established an RPP. Engaging labor, academia, and nonprofit groups already working closely with specific worker populations in these efforts would help ensure that materials are designed in collaboration with, meet the needs of, and are provided to workers, particularly those in difficult-to-reach settings who are most vulnerable, including those not currently under OSHA’s jurisdiction.

To be effective, training programs need to be developed based on best practices for training development and be competency based, scalable, and accessible. Having established competencies from the funding organization can help ensure message consistency while allowing flexibility for tailoring of materials to different populations. The programs would benefit from expertise in all relevant fields, including but not limited to adult education methods, instructional design, human factors engineering, and cognitive engineering. Examples of mechanisms that could be leveraged to implement this recommendation include OSHA’s Susan Harwood Training Grant funding opportunity and NIEHS’s Worker Training Program. Other models for reaching vulnerable groups should also be considered, including use of community health workers and others with personal knowledge of local communities (e.g., peer safety liaisons, promotoras).

Incorporating Lifecycle Learning and Continuous Improvement (Function F5)

A framework for workers needs to be grounded in an understanding of the scope and contexts of respiratory protection needs in occupational settings. Currently, however, such understanding is limited by regulatory and public health agencies’ inadequate collection of data needed for assessing and evaluating risks of workplace hazards and compliance with respiratory protection regulations. Moreover, the science and research foundation for understanding the successful implementation of RPPs for all workers (implementation science) is relatively sparse, limiting the ability of public health and regulatory agencies to disseminate best practices, ensure their proper implementation, and enforce RPPs. These gaps need to be addressed as part of a process for continuous improvement of the committee’s worker framework. The committee envisions NIOSH assuming a leadership role in the development of a robust research program that includes both intramural and extramural research and focuses on basic respirator design and implementation science. Workers currently prevented from using traditional tight-fitting respirators because of physical limitations will need to have respiratory protection that does not pose additional physiologic burdens. Gaps in protection for workers whose religion requires wearing a beard, those who must communicate extensively while at work, and others who are not currently served by readily available respirators will also need to be addressed. The increased level of NIOSH effort necessitated by the committee’s recommendations, including the personnel and data requirements of such research and surveillance programs, will require substantial resources.

APPLYING THE COMMITTEE’S GENERAL FRAMEWORK TO THE RESPIRATORY PROTECTION NEEDS OF THE PUBLIC

Ensuring Adequate Coordination (Function F6) and Authorities to Protect the Public from Inhalation Hazards

While largely centralized oversight authorities for occupational inhalation hazards exist in NIOSH and in OSHA, there is no corollary structure in the context of public protection, and there are gaps in critical authorities, particularly related to conformity assessment and approval of respiratory protective devices. Stakeholders and authorities may vary depending on whether the hazard in question is an infectious agent, such as SARS-CoV-2, or an environmental hazard, such as wildfire smoke, as well as on where

the exposure occurs. Given this complex landscape, there is a critical need for a coordinating entity with the necessary leadership, resources, and oversight to integrate the efforts of all stakeholders so as to enhance the nation’s preparedness and provide an actionable response when the public is exposed to inhalation hazards. An entity responsible for ensuring that the right respiratory protection is available to the public at the right time, with guidance on its effective use and responsibility for eliminating disparities in access and use, is an urgent need.

With respect to potential organizational structures to facilitate such coordination, the committee favors a hub-and-spoke model whereby functions can be distributed across multiple stakeholder entities (the spokes), but the coordinating entity serves as a central hub and functions as a unified and authoritative source of information and effective oversight in the development, approval, and use of respiratory protective devices. This model would allow the domain-specific expertise and infrastructure of existing stakeholders to be leveraged while providing mechanisms for coordinating these multiple efforts toward a shared objective. Of note, while this coordinating entity should be focused on the respiratory protection needs of the public, coordination with OSHA on respiratory protection issues that overlap with the needs of workers is critical to reducing the potential for conflicting messages and confusion, and to ensuring a seamless system for the nation. Issues requiring collaboration with OSHA might include designing communication and messaging, ensuring a robust supply chain for both workers and the public, and carrying out coordinated research on respiratory protection.

While a coordinating entity is necessary to harness the authorities, resources, and domain-specific expertise of all stakeholders and ensure that the functions encompassed by the committee’s framework are carried out seamlessly to meet the respiratory protection needs of the public, each function may require one or more leads with the necessary domain-specific expertise, resources, and authority to serve in an oversight role (see Table S-1). One critical task as the framework for the public is implemented will be to identify the various entities and stakeholders that are active with regard to carrying out these functions, as well as those that could be engaged.⁷

Developing and Approving Respiratory Protective Devices (Function F0)

In contrast with NIOSH/NPPTL for occupational settings, no federal entity is responsible for overseeing the development, approval, marketing, and postmarketing surveillance of all respiratory protective devices for the public, or for generating or overseeing a conformity assessment program that would manage these processes. Current devices used by the public in the face of inhalation hazards are a mix of NIOSH-approved industrial respirators, medical and nuisance dust masks, and a variety of other commercial and homemade face coverings. No comprehensive study has been undertaken to characterize the public as users of respiratory protection or to assess their equipment needs. As a result, the numerous factors that affect the design and appropriate use of respiratory protection for the public (e.g., facial characteristics and fit, acceptable breathing resistance, wearability, the need for an end-of-service-life indicator) are not well understood.

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⁷ Note that the order in which the committee’s recommendations are presented in this Summary differs from that in the respective chapter of the full report. Recommendation 7-2 can be found later in this Summary.

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

* All functions will require adequate financial resources.

To address these major shortfalls, a robust research and approval program is needed to evaluate these needs and requirements systematically, and to guide the development of comprehensive performance standards and innovative respiratory protective devices designed specifically for the wide range of public users, including infants, children, and the frail elderly.

Two approaches could be taken to establishing the necessary capability, each with pros and cons such that the committee did not identify one as preferable to the other: (1) expand capacity and funding for NPPTL; or (2) establish a new laboratory within HHS, separate from but collaborating with NPPTL. The choice between these two approaches should be based on consideration of the differences between the populations to be covered (i.e., the general population versus workers) and the implications for the necessary capabilities of the laboratory, the comparative efficiencies of the two approaches, and the administrative infrastructure that would need to be created around providing respiratory protection for the public.

Assessing Hazards and Determining the Need for Respiratory Protection (Function F1)

To protect the public from such diverse inhalation hazards as wildfire smoke, dust storms, infectious aerosols, and mold, among others, the coordinating entity will need to survey, on an ongoing basis, existing and/or emerging hazards that might warrant the public’s use of respiratory protection, and to oversee a standardized, rigorous process for compiling existing knowledge on exposure and risk to guide the public on their need for respiratory protection. This core function will require coordination across multiple agencies (e.g., CDC, EPA) based on the relevant scientific and administrative expertise of each and the nature of the inhalation hazard in question.

Determining the Necessary Respiratory Protective Devices (Function F2)

Current processes for generating recommendations on devices to meet the public’s needs for respiratory protection are ad hoc and often rely on collaborative relationships among multiple federal stakeholders. Needed is a formalized and enduring process and structure with a clear lead organization responsible for determining which existing respiratory protective devices best meet the needs of the public based on evaluation of the particular hazard and risks (Function F2) and review of the technical specifications and capabilities of existing devices.

described in Recommendation 7-5 to identify and make recommendations to the coordinating entity on approved respiratory protective devices that best meet the respiratory protection requirements of the public. When no approved device exists that meets the identified requirements, the laboratory should oversee efforts to address this gap, consistent with its role in Function F0.

Recommendation 7-6: Use Hazard and Risk Evaluations to Determine the Necessary Respiratory Protective Devices for the Public

Ensuring Availability and Access Pathways for Respiratory Protective Devices (Function F3)

The COVID-19 pandemic has exposed severe limitations in existing supply chains for respiratory protective devices, including N95 filtering facepiece and other types of respirators. National shortages of NIOSH-approved respirators prompted the importation and production and public use of products with unknown efficacy in protecting against specified hazards. There were also clear disparities in who had access to respiratory protective devices, leading to a widening of the differences in COVID-19 risk across some groups. A strategy for ensuring effective supply chain management for respiratory protection that addresses health equity needs is a critical component of and gap in the nation’s preparedness infrastructure.

Engaging, Informing, and Ensuring Access for the Target Community (Function F4)

The public needs clear, consistent, and timely guidance on the selection, acquisition, and effective use of appropriate respiratory protective devices

for specific hazards. Such guidance needs to address their risk perceptions, preferences, and beliefs around each hazard. It is critical that messages be developed with input from a broad range of experts to ensure accuracy, and tested with members of the target audiences to ensure that they have the intended effect in different population groups. While guidance can and should be provided directly to the public, its acceptability and use are amplified when it is conveyed through trusted sources who routinely engage with and communicate health information to the public, including health care providers and health systems, faith leaders, community leaders, and community-based organizations with broad reach to specific population groups.

Currently, the critical responsibility of providing guidance to the public on the medical indications for and use of respiratory protection falls to health care providers and public health professionals. Many of these professionals lack adequate training and the tools and resources needed to perform this function well. To be effective in this role, they need to be equipped with a level of knowledge that will enable them to support members of the public in selecting, fitting, using, and caring for respiratory protective devices that will help protect them from inhalation hazards. There are currently no formal requirements or mechanisms for health care and public health professionals to be trained in respiratory protection, a gap that needs to be addressed.

Specifically, the committee suggests the following considerations:

• CDC should serve as the focal point for assurance that guidance materials are accessible to and appropriate for the general population and its many subgroups. While other federal agencies (e.g., EPA, the Federal Emergency Management Agency) will be involved in developing the guidance, harmonization will be necessary to avoid

• conflicting information. CDC should develop formalized mechanisms for that purpose.
• In addition to partner federal agencies, CDC should gather input from other key stakeholders, such as local, state, and tribal partners and nongovernmental groups, including medical care providers and health systems, faith leaders, community leaders, and community-based organizations with reach to specific population groups.
• CDC should test the guidance as part of ongoing preparedness activities and periodically following its dissemination to ensure that it is appropriate for diverse population groups and determine whether it needs to be refined as information and contexts change.
• CDC should ensure that mechanisms for reaching critical partners for dissemination, including local, state, and tribal agencies, as well as community organizations, have been explored and tested, along with routes for direct dissemination to individuals. CDC should map the reach of its communications to ensure that they can reach all segments of the population.
• CDC should partner with medical and public health professionals and societies, as well as device manufacturers and retailers, to develop, test, and disseminate training modules and guidance appropriate for health care and public health professionals and community health workers so they will be prepared to provide guidance to and respond to questions from the public about health risks associated with inhalation hazards and respiratory protective devices.
• If CDC is made aware of the spread of misinformation, it should develop and disseminate improved versions of the guidance to counter such misinformation.

Incorporating Lifecycle Learning and Continuous Improvement (Function F5)

To ensure that the framework evolves and can anticipate and be responsive to future threats, learning and improvement need to be purposefully driven and reinforced by mechanisms for accountability. Progress needs to be evaluated continuously against established benchmarks, and the roadmap for the future of respiratory protection for the public regularly updated. For example, the development of respiratory protective devices that best meet the needs of the public will require tracking and analyzing technology advances and directing research to the most pressing knowledge gaps. Developing the nascent knowledge base related to public use of respiratory protective devices will require a directed and expansive science- and policy-driven effort that needs to be guided by a coordinated research agenda.

COORDINATION BETWEEN THE WORKER-AND PUBLIC-FOCUSED FRAMEWORKS

As described above, in responding to its charge, the committee developed a general framework for oversight and guidance to meet respiratory protection needs, and from that general framework, frameworks targeted to two broad population groups: workers, including those not currently covered by respiratory protection programs, and the public. The frameworks for workers and the public are grounded in the seven functions of the general framework. Consequently, the elements of the two frameworks cover these functions, and there is inherent overlap in the activities of the groups tasked with carrying out these functions and in the science guiding those activities. While workers and the public are addressed separately by these frameworks, it also bears acknowledging that there is in fact overlap between these two target population groups; outside of the work setting, workers make up a substantial proportion of the general population. Thus, harmonization between the two frameworks and coordination between those entities serving in oversight roles for each is vital.

While the coordinating entities for the two frameworks are likely to be housed in different agencies—the Department of Labor/OSHA and HHS—the committee urges that pathways for coordination and collaboration be established from the outset as the new frameworks are implemented. Points for collaboration and coordination include but are not limited to the following:

• Function F0: Collaboration and coordination will benefit the development of respiratory protective devices, particularly to reflect the heterogeneity of the populations to be covered. The testing and certification processes of NIOSH/NPPPTL will be a useful starting point for developing laboratory capacity for testing devices designed for use by the public.
• Function F1: For hazards of concern to both workers and the general population, risk evaluations can be shared for those agents to which both groups are exposed (e.g., wildfire smoke).
• Function F4: Substantial investment and effort will be needed to develop diverse communication materials that are effective for all segments of the population. Some materials might be developed jointly and successes and failures shared.
• Function F5: Research to address gaps and improve the functioning of the framework will be an ongoing need. Coordination on developing and maintaining a strategic research agenda will lead to efficiency and beneficial synergies.

Given the benefits of collaboration and coordination, the committee offers the following recommendation:

Including ongoing evaluation of harmonization of the two frameworks among the requirements for regular assessment and reporting proposed in Recommendation 7-9 will serve to ensure that objectives related to collaboration and coordination are met.

CONCLUDING THOUGHTS

For decades, the nation’s systems for ensuring respiratory protection have been focused on a small subset of the U.S. population—those workers who are exposed to inhalation hazards as an intrinsic consequence of their jobs and for whom RPPs are required by law. As described in this report, the threats from inhalation hazards extend far beyond this group of workers, and indeed impact every person in the United States, as well as Americans abroad. The wildfires that have ravaged the western United

States in recent years are likely to remain a recurring threat to the quality of the air people breathe. Air pollution in foreign countries will also continue to affect the health of U.S. workers and their families stationed overseas. The future for SARS-CoV-2 remains unclear, but history makes clear that future epidemics of emergent airborne infectious agents can be expected.

It is impossible to know what is coming next, but the nation must be better prepared for future airborne threats. Given the human and financial costs of inaction, the nation cannot afford to repeat the ad hoc efforts made during the COVID-19 pandemic to address safety and respiratory protection. All workers and the public need to be able to turn to a clear and authoritative source of information on inhalation hazards and how they can protect themselves from those hazards, and a system for providing accurate guidance and support to ensure access to and effective use of respiratory protective devices needs to be in place. Furthermore, the needs and resources of the most vulnerable population groups must be considered. The problem is of such magnitude and the current systems are so fragmented that action is required at the highest levels. As climate change increases the incidence and severity of wildfires, hurricanes, floods, infectious disease outbreaks, and other phenomena that impact air quality and human health, it is imperative that the United States close the gaps addressed by this report and ensure that the respiratory protection needs of all workers and the public are met.