6

Respiratory Protection Oversight and Guidance for Workers

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 the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA). This system, properly implemented, should ensure that employers provide respiratory protection for workers covered by respiratory protection programs (RPPs). As discussed in Chapters 2 and 3, however, there remain large numbers of workers who are exposed to inhalation hazards that increase their risk of illness but are not covered by these OSHA-mandated programs (or programs required by other federal agencies, such as the Mine Safety and Health Administration [MSHA], the Environmental Protection Agency [EPA], and the Department of Energy [DOE]). Self-employed workers and independent contractors, gig workers, some public-sector and farm workers, and unpaid (volunteer) workers fall outside OSHA’s authority. As a result, for many workers and for many types of exposures (e.g., wildfire smoke and airborne infectious agents such as coronaviruses), there is no authority that requires provision of an RPP. Therefore, a system is needed to ensure that when inhalation hazards are present in the work environment, workers are provided with protection that is sufficient to eliminate or adequately reduce their exposure to prevent future disease. Given legislative limitations, the variability and uncertainty in risk estimates for emerging hazards, and the large numbers of workers potentially affected, the committee recognizes the challenges inherent in extending the current OSHA model to cover most workers.

ENSURING ADEQUATE AUTHORITIES TO PROTECT WORKERS FROM INHALATION HAZARDS

The Occupational Safety and Health (OSH) Act of 1970 established OSHA within the Department of Labor, giving it substantial authority over regulation of the safety and health of many workplaces and respiratory protection for workers in those workplaces. The Act specifically applies to “employers,” defining an employer as a “person engaged in a business affecting commerce who has employees,” although this definition “does not include the United States (not including the United States Postal Service) or any State or political subdivision of a State.”¹ Under the Act, states that choose to have their own occupational safety and health plans must cover state and local government agencies in those states, and states that are under federal jurisdiction may elect to have occupational safety and health plans for state and county workers not covered by the federal agency. Currently, 21 states and Puerto Rico have state plans covering private- and public-sector workers, and 5 states and the U.S. Virgin Islands have plans covering only state and local workers (OSHA, 2021). Meanwhile, both the OSH Act and Executive Order 12196 require federal agencies to be responsible for establishing and maintaining an occupational safety and health program that complies with the terms of the OSH Act.²

Similarly, the OSH Act extends protection to “employees,” who are defined as: “an employee of an employer who is employed in a business of his employer which affects commerce.”³ As detailed in Chapter 2, OSHA has interpreted its authority under the OSH Act to exclude many contract workers, as well as unpaid volunteers, sole proprietors, family members of farm employees, domestic workers, and the self-employed. Under this interpretation, a business owner who uses contract labor may be largely outside the authority of OSHA.

Additionally, the OSH Act limits OSHA’s authority in circumstances in which other federal agencies “exercise statutory authority to prescribe or enforce standards or regulations affecting occupational safety or health.”⁴ In some cases, those agencies defer to OSHA standards for worker protection, including the Respiratory Protection Standard, but they are under no obligation to do so.

OSHA’s workplace safety and health standards, most notably its Respiratory Protection Standard and regulations issued by other federal agencies, such as MSHA, EPA, and DOE, require employers to establish and

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¹ 29 U.S.C. § 652.

² See https://www.archives.gov/federal-register/codification/executive-order/12196.html (accessed September 21, 2021).

³ 29 U.S.C. § 652.

⁴ 29 U.S.C. § 653(b)(1).

implement an RPP for workplaces where respirators are necessary to protect the health of employees from known inhalation hazards. As discussed in Chapter 3, however, only a small percentage are covered by RPPs or by mandatory workplace safety standards addressing the use of respiratory protection. Consequently, in the face of novel or unanticipated threats, such as wildfire smoke or SARS-CoV-2, there is no preexisting foundation for ensuring adequate respiratory protection for most workers not covered by RPPs.

The committee examined other models of worker safety and health regulation around the world, particularly worker protection laws based on the legal concept of “duty of care” (Commission for Occupational Safety and Health, 2005). Under this system, the person or institution conducting a business has a primary duty of care to ensure the health and safety of everyone in the workplace, including visitors. Regulations are written to codify these duties and requirements, and their broad applicability encompasses everyone in the workplace.

The committee recognizes that Congress has the ability to expand OSHA’s coverage of employers and workers to explicitly encompass many categories of workers currently excluded from that coverage and can enact legislation requiring that workers, as well as nonworkers, be provided appropriate respiratory protection in the workplace. Such congressional action is required to make needed and significant changes in OSHA authority and employer responsibility to ensure that protections are accessible and equitable. The categories of workers who could be covered under expanded definitions include unpaid volunteers, family members of farm employees, domestic workers in residential settings, gig workers, and many workers now categorized as independent contractors.

An appropriations provision passed annually by Congress since 1976 prohibits OSHA from any activity on farms with 10 or fewer nonfamily employees (OSHA, 2014), essentially turning small farms into OSHA-free zones. Elimination of this provision would be an important step toward improving respiratory protection for farm workers, a category of workers at greatly increased risk of exposure to wildfire smoke and SARS-CoV-2 (Lewnard et al., 2021; Riden et al., 2020).

Much more could be done by states as well to improve respiratory protection for workers not currently covered by an OSHA-compliant RPP. One clear gap in coverage comprises state and local public-sector workers in states in which private-sector employers are covered by federal OSHA. While Congress may not be able to expand federal OSHA coverage of these workers because of constitutional concerns, it could provide monetary incentives for states to create occupational safety and health plans for their own public-sector workers and disincentives for those who fail to do so. Such a step could help mitigate the equity issues that arise with

state-by-state approaches to meeting workers’ respiratory protection needs. States with OSHA programs that currently cover both private- and public-sector workers could also directly address gaps in coverage by passing legislation to expand the categories of workers covered by those programs, including the same categories cited above.

The committee observes that it is inconsistent as well as ineffective for the government to have rules that make an employer responsible for providing an RPP for some workers on its premises but not others, nor for nonworkers who are on its premises or nearby and whose health is directly impacted by the employer’s actions.

As discussed in Chapter 2, OSHA’s definitions of employer and employee are vague and circular, and the agency has substantial discretion to adopt broader definitions for both. Without waiting for congressional action, OSHA could reinterpret the types of workers covered under current law, potentially expanding coverage for categories of workers cited above, including unpaid volunteers, family members of farm employees, domestic workers in residential settings, and many workers now categorized as independent contractors.

The following two recommendations represent the committee’s attempt to address the significant gaps in OSHA coverage, gaps that preclude the agency from requiring employers to provide respiratory protection for many millions of workers not currently covered by an OSHA-compliant RPP.

Pending revisions to the OSH Act:

• OSHA should adopt the broadest permissible interpretation of “employees” and “employers” under the act such that workers currently excluded based on existing interpretation, including individuals considered to be employees under other DOL statutes or regulations, are not excluded from respiratory protection requirements. If OSHA does not take action to this end within 1 year, the White House should direct OSHA to reconsider its interpretation of the statute.
• Congress should ensure that OSHA’s respiratory protection requirements can be applied to and enforced for farms with 10 or fewer workers.

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 entailed in taking what may be considered a radical step and that there are 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.

MEETING WORKER NEEDS: APPLICATION OF THE COMMITTEE’S FRAMEWORK

Chapter 5 introduces the committee’s general framework for respiratory protection for workers not covered by RPPs and the public. The overall system described by this general framework comprises seven functions necessary to ensuring access to and appropriate use of respiratory protection when needed. This section details how the current system for workers covers each of these functions and the steps necessary to implement a framework targeted specifically to workers not covered by RPPs in order to fulfill each function. Several components of the current system that involves OSHA and NIOSH through the National Personal Protective Technology Laboratory (NPPTL) correspond to the committee’s general framework, but gaps in this system with respect to workers not covered by RPPs (described in Chapter 3) need to be addressed. To that end, the committee considers that the current arrangement could function more broadly. One critical element toward success for a framework targeting workers currently not within OSHA’s purview, pending adoption of the above recommendation, would be designating OSHA, in collaboration with NIOSH, as the overall coordinating entity to oversee the functions of the committee’s general framework.

Function F0: Develop and Approve Respiratory Protective Devices

In the context of worker health, a NIOSH-approved respirator is currently the only appropriate respiratory protective device for protecting workers facing inhalation hazards. Development and approval of respirators in the United States involves a partnership between the private and public sectors. Private companies conduct research, develop new products,

manufacture those products, and distribute them to users. Manufacturers design their products to comply with performance standards established by regulation, conduct premarket testing to applicable standards and regulations, and continually test their products as part of their quality management processes. NIOSH conducts research and conformity assessment for respirators, and OSHA and MSHA require employers to select only those devices approved by NIOSH. Both private and public entities participate in standards setting through consensus standards bodies such as the American National Standards Institute (ANSI), ASTM, and the National Fire Protection Association (NFPA), as well as through participation in the rulemaking process for government standards. The committee has concluded that additional research (see Recommendation 6-8 under Function 5) and increased coordination between public- and private-sector entities are needed to ensure the development of respirators that address the respiratory protection needs of workers who are not currently covered by OSHA-mandated RPPs and who face a diverse group of hazards. Under the committee’s proposed framework for these workers, NIOSH would be responsible for applying the findings of this research to ensure the applicability of its standards for respirators. In response to these new requirements, private firms would design and develop appropriate respirators for different exposure circumstances and worker populations.

As the oversight entity for respirator conformity assessment⁵ in the United States (i.e., the scheme owner), NIOSH has responsibilities that include product testing in its laboratories, evaluation of manufacturers’ quality control management systems, periodic testing of products being offered in the marketplace, and inspection of manufacturing facilities. NIOSH provides a certification mark for those respirators that meet its requirements and maintains a listing of those respirators that are approved for users and purchasers. Importantly, there has been a recent expansion of the manufacture and use of devices (i.e., nonmedical masks and face coverings) that are not used within RPPs and do not fit within NIOSH’s current conformity assessment activities (NIOSH, 2021). There is no formal government certification or approval of these devices.

Because NIOSH’s testing standards for various types of respirators are contained in regulation, establishment of new or revision of current standards must go through rulemaking, including publication in the Federal Register and the process of soliciting and receiving public comments. This method has at times proven to be inefficient, with the potential to result in substantial delays in advancing necessary standards (IOM and NRC, 2008).

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⁵ Conformity assessment is the demonstration that a product meets specified requirements. Conformity assessment can verify that a particular product meets a given level of quality or safety.

The National Technology Transfer and Advancement Act directs federal agencies to adopt voluntary consensus standards wherever possible (avoiding the development of unique government standards) and establishes reporting requirements.⁶ The Food and Drug Administration (FDA) relies on consensus standards when clearing medical masks for sale. Consensus standards and test methods are incorporated by reference in the 42 C.F.R. § 84 regulations, and NIOSH participates in committees that develop consensus standards. For example, following an unsuccessful attempt to incorporate total inward leakage testing into its regulatory standard for air purifying respirators, NIOSH took a leadership role in the development of the ASTM voluntary standard F3407-20 for respirator fit capability testing (Coffey and Miller, 2019). However, this ASTM standard does not affect respirator certification requirements as it was not promulgated through the NIOSH regulations.

NIOSH conducts all testing of respirators for certification. This testing is carried out by NIOSH personnel at NPPTL. No alternative laboratory is available in case of a disruption caused by a malfunction of equipment or problem with the facility (e.g., 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. Moreover, the committee expects that NIOSH’s responsibilities and associated capabilities in this area will need to expand in response to increased needs for research addressing respiratory protection for new groups of workers. To ensure the capacity to respond to this increased need under the committee’s proposed framework, the agency could incorporate into its respirator approval program a third-party laboratory testing process, an approach used in other conformity assessment programs outside of respiratory protection (RTI International, 2014). Challenges are involved in such an approach, including ensuring the competency of third-party laboratories to conduct suitable tests and establishing a system for evaluating and confirming these laboratories’ test results. The director of NPPTL has confirmed that NIOSH is actively exploring ways in which it could incorporate the use of independent third-party laboratories into its respirator approval program.

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⁶ U.S.C. § 3701—National Technology Transfer and Advancement Act.

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.

Function F1: Assess Hazard and Determine Need for Respiratory Protection

Under the current system for occupational safety and health in the United States, employers are required to determine the need for respiratory protection, and must comply with standards issued by OSHA (or other agencies with regulatory authorities, such as EPA and MSHA). However, OSHA does not require employers to provide an RPP in all contexts in which inhalation hazards are present. In the absence of a recognized inhalation hazard, OSHA does not require employers to conduct monitoring (e.g., air sampling) that could result in the identification of a hazard and the requirement to implement an RPP, and many likely do not do so in order to avoid having to initiate such a program.

OSHA does have hazard-specific comprehensive standards that require employers to follow the hierarchy of controls to limit workers’ exposure, and in many cases, the use of respirators will be necessary to maintain exposure levels at or below the permissible exposure level (PEL), which is one element of the standard. Absent a comprehensive standard, OSHA has PELs for a number of chemical exposures (Howard, 2005) that do not require application of the hierarchy of controls, and employers are obligated to initiate an RPP only if they conduct an assessment and determine that such a program is necessary (Ryan, 2001). Despite these regulatory limitations, the committee firmly supports use of the hierarchy of controls for emerging hazards and encourages research to reduce the need for respiratory protection wherever possible.

The respiratory protection needs of workers not covered by OSHA-mandated RPPs may also be addressed in nonenforceable guidance documents issued by OSHA, NIOSH (e.g., recommended exposure limits), and other agencies. While OSHA and NIOSH have produced these sorts of documents, the current landscape calls for the issuance of more comprehensive guidelines.

Under the committee’s proposed framework, employers, including those whose employees generally do not require respiratory protection to

carry out their job duties, would monitor situations in which workers are exposed to inhalation hazards, examining and quantifying the hazards and associated risks. In cases in which effective engineering or administrative controls were not feasible or available, employers would evaluate the need for their workers to use respirators.

As noted in Chapter 2, most workers are not covered by an RPP or by mandatory workplace safety standards addressing the use of respiratory protection. Yet recent experiences with novel and unanticipated threats, such as wildfire smoke and SARS-CoV-2, indicate 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 under which particulate matter (PM) is covered, as discussed further below, impede efforts to institute respiratory protection measures systematically 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. For example, OSHA’s recognition of additional inhalation hazards as significant through investment in additional hazard identification would trigger employers’ responsibilities under the OSH Act’s General Duty Clause, which requires them to furnish their employees with “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.”⁷ As noted below, this approach is consistent with current Supreme Court precedent as long as OSHA finds that workers face a significant risk from respiratory hazard(s).⁸ This approach could have been applied during the COVID-19 pandemic, for example, when OSHA could have required that employers in high-risk workplaces other than health care settings implement RPPs and provide workers with appropriate respirators. However, absent other changes in how “employees” are defined, expansion of RPP requirements under current law would not include volunteers, gig workers, independent contractors, and other workers not covered by OSHA. OSHA has both the statutory authority to implement new RPP requirements when inhalation hazards pose a “significant risk” to workers under its authority—including when those risks are periodic in nature—and the

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⁷ 29 U.S.C. § 654(a)(1).

⁸ OSHA is authorized to promulgate health and safety standards in the workplace only after it has satisfied the requirement 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 called the “Benzene decision”) 448 U.S. 607 (1980).

expertise to guide employers in implementing such requirements. States including California, Washington, and Oregon have recently introduced standards for workers exposed to wildfire smoke that include triggers for RPP requirements based on Air Quality Index levels for PM_2.5 (Cal/OSHA, 2021; Oregon OSHA, 2021; Washington State DOLI, 2021), while several state-level emergency temporary standards for COVID-19 prevention include RPP requirements if certain exposure thresholds are met (Oregon OSHA, 2020). California’s Aerosol Transmissible Diseases standard further requires use of respiratory protection when workers are exposed to novel pathogens for which airborne transmission cannot be ruled out, thereby adopting a precautionary approach when scientific evidence is lacking.⁹ Working with states that have already promulgated such standards and building on those examples, OSHA could address the need for national-level standards for PM and airborne infectious disease agents. However, the federal OSHA standards-setting process is slow and cumbersome (Howard, 2005), and it would not be easy for OSHA to issue standards of this type. During the HIV/AIDS crisis, Congress facilitated the prompter issuance of OSHA standards by legislating deadlines; this approach was implemented in the Needlestick Safety and Prevention Act,¹⁰ which directed OSHA to strengthen its existing Bloodborne Pathogens Standard to incorporate the hierarchy of controls (Foley, 2004). Further research on both the health risks of various respiratory exposures and the effectiveness of existing standards would help guide OSHA in implementing new requirements that would adequately protect worker groups currently not covered by RPPs (see Recommendations 6-8 and 6-9 under Function 5).

In circumstances in which employees are exposed to “grave danger from exposure,” and improved respiratory protection is “necessary” to reduce the danger, OSHA is also authorized to require additional respiratory protection by issuing an Emergency Temporary Standard (ETS).¹¹ OSHA used this authority to issue the mini RPP for health care workers as part of its 2021 ETS for COVID-19.¹² Such an approach may be useful in emergency circumstances when increased respiratory protection is needed for emergent dangers, including situations involving wildfire smoke or airborne pathogens such as SARS-CoV-2. However, the protection offered by an ETS is temporary, and must generally proceed to additional rulemaking procedures. In addition, where this approach is used to adopt modified or less comprehensive (or expensive) RPPs, as with the COVID-19 ETS, it is

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⁹ Cal. Civ. Code § 5199 Aerosol Transmissible Diseases.

¹⁰Needlestick Safety and Prevention Act, Public Law 106-430.

¹¹ 29 U.S.C. § 655(c).

¹² See C.F.R. § 1910.504—Mini Respiratory Protection Program; https://osha.gov/laws-regs/regulations/standardnumber/1910/1910.504 (accessed October 3, 2021).

important to understand the impact of dropping or modifying some of the required RPP components, including medical examinations; fit testing; and training in, among other areas, care and maintenance of the respirator. Information on the fit characteristics of respirators when used outside of an RPP would be useful as approaches such as that of the mini RPP are considered. Important as well would be to conduct appropriate research to develop respirators that would address any current deficiencies.

OSHA currently covers exposure to PM that is not included in hazard-specific standards such as that for crystalline silica through the Permissible Exposure Limit 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) (NIOSH, 2011).

Of note, the 24-hour National Ambient Air Quality Standard (NAAQS) for fine PM (PM_2.5) of 35 µg/m³ (CRS, 2013) is orders of magnitude less than the PNOR PEL. OSHA’s PNOR PEL far exceeds levels 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 (Adetona et al., 2016; Doubleday et al., 2020; Reid et al., 2016; Rice et al., 2021). Thus the current PNOR PEL does not provide adequate protection for workers exposed to wildfire smoke.

With Recommendation 6-4, the committee proposes that OSHA issue a new evidence-based PM standard with more health-relevant indicators and greater protection to replace the legacy standard of 5 mg/m³. The

outdated nature of OSHA’s current PEL underscores the need for regular review and updating of the standards. Also important in the development of science-based standards is consideration of the appropriate PM indicator. As discussed in Chapter 1, PM includes particles of varying sizes, and particle size has implications for deposition in the respiratory tract and associated health effects.

While Recommendation 6-4 focuses on PM 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 its scope, OSHA will need to explore creative approaches to undertaking such an effort 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 (NIOSH, 2013; Sietsema et al., 2019), which have been incorporated into regulatory systems outside the United States¹³ and provide an alternative to establishing quantitative exposure limits and setting standards on a contaminant-by-contaminant basis.

Function F2: Determine the Necessary Respiratory Protective Devices

Currently, OSHA, NIOSH, and other agencies may provide recommendations for use of respirators by workers not covered by RPPs, although there is no system in place to ensure that these recommendations are issued or updated. Under the committee’s proposed framework, employers, following any relevant OSHA standards and regulations, would be responsible for determining which approved respirator should be used by workers exposed to the hazard in question 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.

As discussed in Chapter 2, in 2021 NIOSH issued interim guidance with criteria for Workplace Performance and Workplace Performance Plus masks (NIOSH, 2021). The new NIOSH criteria, which build upon the ASTM F3502-21 standard for barrier face coverings, were intended to guide the manufacture of devices that can help protect people in the workplace from SARS-CoV-2. However, based on a review of the literature on the performance of face coverings, medical masks, and respirators (see Appendix B), the committee believes the filtration and fit characteristics of

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¹³ See, for example, the Canadian Respiratory Protection Standard CAN/CSA-Z94.4-18.

face coverings and masks currently do not adequately protect workers facing inhalation hazards, including fine inhalable particles (PM_2.5 or smaller) or the tiny aerosol particles through which SARs-COV-2 and influenza are transmitted. 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). As innovation drives advances in technology, evaluations by NIOSH will be needed to determine whether respiratory protective devices other than respirators might be appropriate for use by workers facing inhalation hazards in the future. The committee expects that implementation of its framework would result in maintenance and distribution of an adequate national supply of NIOSH-approved respirators. If shortages did occur, OSHA and NIOSH would need to recommend alternatives.

Function F3: Ensure Availability and Access Pathways for Respiratory Protective Devices

The COVID-19 pandemic exposed severe limitations in existing supply chains for all forms of respirators, ranging from disposable N95 filtering facepiece respirators (FFRs) to reusable elastomeric facepiece respirators and powered air-purifying respirators (PAPRs). The shortage of NIOSH-approved N95 FFRs early in the COVID-19 pandemic contributed to the lack of adequate protection for many health care (Grimm, 2020; Mason and Friese, 2020) and other workers who require respirators to conduct their job duties safely (EPA, 2020), necessitating the implementation of contingency and crisis strategies (Andrews et al., 2021; de Perio et al., 2020). Market limitations also reduce manufacturers’ interest in developing and

marketing new respiratory protective products absent government regulation or guaranteed purchase (Patel et al., 2017). For example, although the needs of wildland firefighters have been assessed, and NIOSH worked with the NFPA to develop requirements for respiratory protection a decade ago, no manufacturer has produced a commercially available respirator meeting the requirements of NFPA 1984 (NASEM, 2021). NIOSH recognizes this gap in its Research to Practice portfolio, but would benefit from the additional purchasing power of other federal agencies (Watney, 2020), such as the Department of Defense, the Veterans Health Administration, the U.S. Department of Agriculture, the Department of the Interior, and EPA.

While the nation does have a system for stockpiling respirators, medical masks, and other materials needed for pandemic response (NASEM, 2016), the COVID-19 experience has shown that this system is not currently functioning adequately. The Strategic National Stockpile (SNS) was designed to supplement state and local jurisdictions during emergencies (NASEM, 2016). However, given its resource limitations and the inevitable delay associated with distribution of stockpiled materials, employers whose workers require respiratory protection, including health care and long-term care institutions, need to ensure access to sufficient stocks of those devices on an ongoing basis to meet worker needs (Yarbrough et al., 2016), taking storage requirements into account. Reusable devices, such as elastomeric facepiece respirators, may reduce the numbers of devices organizations need to stock in preparation for an emergency (NASEM, 2019) and could be a particular consideration for health care organizations in light of the lessons learned from the COVID-19 pandemic.

Expansion of OSHA’s respiratory protection requirements to a much broader population of workers (Recommendations 6-1 and 6-4) is likely to bring new challenges to ensuring adequate availability of and access to respirators, particularly during such large-scale events as a pandemic. The nature of the needs of this broader group of workers may differ from those of workers traditionally covered by OSHA-mandated RPPs. Beyond the obvious issue of scale, for example, the timing of the need for respiratory protection may be more unpredictable. Under the 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 these same shortages during future emergencies. This determination would be informed by the ongoing hazard assessments discussed above. 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.

Function F4: Engage, Inform, and Ensure Access for the Target Community

With the establishment of OSHA’s workplace exposure standards for wildfire smoke, PM_2.5, and airborne infectious diseases that would trigger RPP requirements (Recommendation 6-4), as well as the expansion of OSHA oversight to a broader group of workers (Recommendation 6-1), employers (especially those running small businesses) and others would likely need assistance in assessing inhalation hazards and facilitating the selection of and training on appropriate respirators. Consequently, as described in Recommendation 6-4, OSHA would need to increase its technical assistance activities aimed at this now expanded group of employers and workers, including those not currently under its authority. For incidents involving airborne transmissible diseases or high levels of air pollution, including wildfire smoke, the coordinating entity for the committee’s framework for the public (as discussed in Chapter 5 and further described in Chapter 7), in consultation with OSHA and NIOSH, would issue warnings to the public (including employers and workers) based on ongoing hazard assessment and surveillance data, with OSHA disseminating information specific to workplace exposures. OSHA would ensure that guidance documents were produced, adapted, and disseminated for a wide range of additional stakeholders. These materials would be tailored to state and local public health agencies, health care professionals, employers, worker organizations, and workers, with a particular focus on those who are currently vulnerable and underserved. These two agencies would also specifically target employers and workers who were not under formal OSHA jurisdiction but needed exposure-specific RPPs.

As described in Chapter 3, 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 guidance 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 to protect against inhalation hazards. To fill this gap, a number of labor, academic, and nonprofit groups have created materials designed for specific worker populations (PERC, 2017; WCAHS, 2021). 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 carrying out their work (i.e., those whose work itself does not generally pose a threat from inhalation hazards but may 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 based on best practices for training development, and be competency based, scalable, and accessible.

Established competencies from the funding organization help ensure message consistency while allowing flexibility for tailoring materials to different populations. OSHA’s Susan Harwood Training Grant Program¹⁴ and NIEHS’s Worker Training Program (NIEHS, 2018) are examples of mechanisms that could be leveraged, and both have generated documents describing training best practices¹⁵ that include the importance of using approaches targeted to the specific language and literacy needs of the intended audience, activity focused, and competency driven to meet the particular needs of adult learners. The development of training programs for workers proposed in Recommendation 6-7 would benefit from expertise in all relevant fields, including, but not limited to, adult education methods, instructional design, human factors engineering, and cognitive engineering. 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). The training would benefit as well from assessment of the educational needs of particular worker subpopulations and evaluation of training outcomes and impacts (Cohen and Colligan, 1998).

Function F5: Incorporate Lifecycle Learning and Continuous Improvement

Continuous learning and improvement relies on a cyclical process that entails collecting performance data, identifying knowledge gaps and problems, investigating potential solutions through research, implementing evidence-based strategies, and finally returning to evaluation of performance. Recognizing that respiratory protection is the least effective approach to reducing risks from inhalation hazards in the hierarchy of controls (although a necessary one), this cycle needs to be integrated into comprehensive research efforts aimed at reducing inhalation hazards (e.g., vaccine development, approaches to reducing greenhouse gas emission, the design of improved engineering controls).

Chapters 2 and 3 identify a number of important research needs that range from developing new respiratory protective devices (e.g., off-the-shelf devices that can utilize a user seal check to ensure proper fit), to identifying

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¹⁴ Information on the Susan Harwood Training Grant Program is available at https://www.osha.gov/harwoodgrants (accessed October 3, 2021).

¹⁵ The NIEHS Worker Training Program publishes “Minimum Criteria for Worker Health and Safety Training for Hazardous Waste Operations and Emergency Response,” available at https://tools.niehs.nih.gov/wetp/public/hasl_get_blob.cfm?ID=11266&file_name=WTP_Minimum_Criteria_062818_Final_508.pdf (accessed October 7, 2021). Best practices from the OSHA Susan Harwood Training Grant Program are available at https://www.osha.gov/harwoodgrants/best-practices (accessed October 7, 2021).

and overcoming deficiencies in production that may arise from market failures, to conducting outreach and education for adequate implementation of respiratory protection in the workplace. Also needed are increased research and data collection on the characteristics and extent of workplace inhalation hazards, as well as methods for preventing exposure.

A paucity of information is available about the effectiveness and scope of OSHA-mandated RPPs among workers exposed to currently regulated inhalation hazards. While OSHA requires employers to maintain written RPP plans and certain data, no attempt is made to collect these data. Even less information is available with which to characterize the needs of workers whose normal working conditions do not require respiratory protection, but who may on occasion encounter high levels of wildfire smoke, other sources of extreme ambient air pollution, or airborne-transmissible infectious agents. Existing RPP requirements for medical clearance and fit testing for respirators address some of the design limitations of these devices, including increased resistance, visual field limitations, and fit characteristics. These RPP requirements identify a number of conditions, including cardiopulmonary disease, claustrophobia, facial disfiguration, or religious requirements for having a beard, that may interfere with the use of FFRs (OSHA, 2000). Workers failing medical clearance or repeated fit testing may be assigned either alternative respiratory protection, such as a PAPR, or alternative work not requiring protection. These RPP components may be poorly understood or perceived as burdensome by employers without previous experience in their implementation, and alternative work options may not be available for emerging hazards. The cost of implementing an RPP is likely one of the barriers to the use of more and better respiratory protection in many workplaces, but barriers to compliance with RPP requirements are not well understood and warrant investigation. To address these gaps, NIOSH would need to expand its research portfolio to support respiratory protection programs, including a focus on a wide range of potential exposure scenarios and workforce needs.

While recognizing the challenges placed by full RPPs on small employers or those lacking prior experience with the requirements, the committee believes that eliminating the requirement for medical clearance or fit testing of respirators for any working population would require additional research data to confirm both the safety of the devices for prolonged use by all workers and their effectiveness in real-world situations. The committee also highlights the need for research into respirator design for fit or for broadly accessible alternatives, such as devices that use blowers with filters and loose-fitting hoods. Additional research is needed to understand how to facilitate prolonged user comfort, reduce impediments to communication, and minimize work effort and heat stress.

Finally, the United States has a number of vulnerable working populations for whom implementation research is needed. The COVID-19 pandemic revealed particularly high exposure risks for workers in various front-line and essential industries—including agriculture, food processing, manufacturing, warehousing, and retail—many of which employ large numbers of low-wage and immigrant workers (Waltenburg et al., 2021). Outdoor workers—such as those engaged in agriculture, construction, and landscaping—are at increased risk from PM_2.5 exposure during wildfire events that impact air quality over large areas (Fenske and Pinkerton, 2021; Zuidema et al., 2021). Moreover, those responding to disasters may include informal and/or temporary workers, such as day laborers, who are often afforded few protections. And the proportion of the U.S. population working with impairments from chronic medical conditions has increased over time (Jinnett et al., 2017). It is important for approaches to be tailored to identify and meet the specific needs of these worker populations, considering not only distinctions by occupation but also other characteristics that may define worker groups.

The following two recommendations focus on surveillance related to inhalation hazards and associated occupational diseases and research aimed at respirator design and use, as well as the specific program elements necessary for effective respiratory protection. These recommendations do not describe a comprehensive research agenda, but instead represent the research areas that could be pursued in the identification of gaps and needs in respiratory protection. It bears emphasizing that these recommendations narrowly target the lowest form of protection in the hierarchy of controls and should be integrated into an overarching research program that addresses primary prevention and engineering and administrative controls. If, for example, “far” ultraviolet-C radiation proved safe, effective, and scalable, it might reduce the risk of infectious exposure to the point where respiratory protection would become unnecessary in certain indoor settings. Likewise, primary pollution prevention could obviate the need for respiratory protection.

As noted, the research needs are extensive and encompass a wide range of technical expertise. NIOSH is unique among CDC centers and institutes in the absence of a National Institutes of Health (NIH) counterpart (e.g., the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry has NIEHS as a related organization) as a complementary federal source of research. In addition to intramural expertise,

NIOSH has established Education and Research Centers¹⁶ and other centers of excellence that make use of extramural researchers (Robison et al., 2020). However, funding for these entities has been constrained. Analogous Personal Protective Technology Centers of Excellence have previously been recommended to support extramural research that would support advances in personal protective equipment (PPE) (IOM and NRC, 2008), but have not been realized because of a lack of funding. NIOSH issued a Federal Register notice in November 2021 to solicit comments on the need to establish personal protective technology centers of excellence to address research and practice gaps (CDC, 2021). Such centers, adequately funded, would support the robust and community-engaged extramural research program envisioned by the committee.

The committee envisions NIOSH assuming a leadership role in the development of a robust research program that would include intramural and extramural research and a focus on basic respirator design and implementation science. Some aspects of this research may be dual-purpose, applying also to use of respiratory protection by the public. The increased level of NIOSH effort anticipated by the committee’s recommendations, including the personnel and data requirements of such research and surveillance programs, would require substantial resources, and could justify additional appropriations from Congress. Moreover, the research would need to be coordinated with other research and purchasing entities within the Department of Health and Human Services (HHS) (e.g., NIH, the Biomedical Advanced Research and Development Authority), the Department of Defense, and the Department of Veterans Affairs to bring proven devices to market; evaluate their use and effectiveness in the field; and track gaps in implementation, especially among the most precarious workers.

Function F6: Coordination

At present, there is little formal coordination among agencies or other entities involved in preventing exposure to inhalation hazards among workers not covered by OSHA-mandated RPPs. The committee’s proposed framework for these workers envisions a system that includes ongoing data collection and interaction with manufacturers, distributors, and purchasers of devices, as well as federal, state, and local government agencies. These functions would make active coordination more important and require a system committed to lifelong learning and continuous improvement. To

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¹⁶ More information about NIOSH Education and Research Centers can be found at https://www.cdc.gov/niosh/oep/ercportfolio.html (accessed October 3, 2021).

this end, OSHA, as the entity responsible for coordinating these functions, would have to make this a high priority.

CONCLUDING REMARKS

Addressing gaps in the provision of respiratory protection for workers not covered by RPPs will require a concerted effort from NIOSH, OSHA, Congress, and others. Table 6-1 summarizes the actions each stakeholder would need to take to make this happen.

TABLE 6-1 Recommended Actions for Stakeholders

REFERENCES