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Appendix C: The Regulatory Landscape Regarding Respiratory Protection
Pages 447-528

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From page 447...
... 454 a. The Occupational Safety and Health Administration (OSHA)
From page 448...
... ..................................................................................497 i. CDC's statutory authority regarding inhalation hazards and public health ..........
From page 449...
... ...........................................510 c. The National Institute for Occupational Safety and Health (NIOSH)
From page 450...
... OSHA has the statutory authority to implement new or expanded RPPs if they find that the respiratory hazards workers are facing are a "significant risk," and so long as the workers are not part of a statutorily excepted group (e.g., state and local government workers or the self-employed)
From page 451...
... Accordingly, this paper (1) describes the existing regulatory landscape regarding respiratory protection, and (2)
From page 452...
... The goal of this paper is to provide the Committee with factual information about the regulatory landscape regarding respiratory hazards. The paper does not recommend or advocate for any particular course of action.
From page 453...
... , which apply in circumstances where OSHA has determined that respiratory hazards present a substantial risk to workers.2 Most workplaces are unprotected by such plans.3 Furthermore, the Occupational Safety and Health Act (OSH Act) limits OSHA's authority over significant categories of workers, including the self-employed, many state and local government workers, and workers who are imperiled by hazards outside OSHA's primary authority.4 While these instances of overlapping authority between OSHA and other agencies add complexity to the regulatory landscape of occupational respiratory protection use, that complexity is addressed at least in part by a statutory provision that displaces OSHA authority where other agencies have regulated, and by the history of coordination between OSHA and other agencies regarding respiratory protection standards.
From page 454...
... and empowered it to set enforceable workplace standards in mines while simultaneously continuing the certification and oversight work of the Bureau of Mines.9 The following year, Congress passed the OSH Act of 1970 to address workplace safety in (most) other workplaces.10 In the OSH Act, however, Congress chose to bifurcate enforcement and research responsibilities, creating and empowering OSHA to issue and enforce enforceable safety standards,11 and NIOSH for research, certification, and other oversight functions.12 The OSH Act also called for establishment of the National Advisory Committee on Occupational Safety and Health (NACOSH)
From page 455...
... . The subsection concludes that, while it has broad authority to set occupational safety and health standards for workers covered by the OSH Act, OSHA's authority is limited in several circumstances, including where the statute excepts classes of workers from OSHA regulation (as with state and local workers and the self-employed)
From page 456...
... Occupational safety and health standards can, and do, address inhalation hazards in the workplace27 -- though these standards are constrained by important limitations on OSHA's authority under the OSH Act.
From page 457...
... .33 OSHA has long adopted a somewhat narrow interpretation of the OSH Act that determines whether a worker qualifies as an "employee" -- and thus whether occupational safety and health standards apply -- at least in part by reference to the (notoriously complex) system of judicial precedent that makes up the common law of agency.34 To determine whether or not a worker is an employee or a self-employed "independent contractor" under common law, the hiring party is required to consider a number of factors, including the degree of control the hiring party asserts over the manner in which the work is done, and the degree of skill and independent judgment the hired party is expected to apply.35 Because this test is multifactorial and fact-specific, it can be difficult to determine for many workers whether they are employees who qualify for protection under the OSH Act standards, or whether they are instead self-employed or independent contractors who 29 29 U.S.C.
From page 458...
... (1) of the OSH Act, was to avoid wasteful duplication, such as might result where both OSHA and another federal agency are providing for the occupational safety of a class of workers.40 While Congress could have managed such overlap in regulatory authority by preferencing OSHA's workplace safety standards, it instead chose to preference standards set by other agencies, when they are acting within their statutory authority, and when they have actually acted to regulate some workplace hazard under that authority.41 As a result, OSHA's authority to enforce occupational safety and health standards is sometimes limited by the actions of other agencies.42 This includes activities and conditions regulated under the control of another dedicated federal agency, such as the conditions in "coal and other mines,"43 as well as where other agencies are authorized to regulate particular hazards, as with occupational inhalation hazards from pesticides.44 Although less obviously relevant in respiratory protection contexts, OSHA's authority is similarly limited over vessels regulated by 36 See generally 153 A.L.R.
From page 459...
... American Petroleum Institute (generally called the "Benzene decision") , which overturned a workplace safety standard under the OSH Act on the grounds that the agency had failed to determine that benzene posed what the plurality of the Supreme Court called a "significant risk" in the workplace.49 The plurality opinion is controversial among legal commentators,50 who note both that the requirement of significant risk is not mentioned in the statute itself and that other portions of the OSH Act demand repeatedly that OSHA regulate to ensure that "no employee will suffer diminished health, functional capacity, or life expectancy as a result of his work experience."51 Nevertheless, the opinion has given rise to a long-standing agency practice at OSHA of demanding substantial information about the significance of a risk prior to issuing new workplace safety standards.52 Because this is a long-standing agency practice, recommendations by the Committee to OSHA regarding respiratory protection would likely need to account for the agency's understanding of the significant risk requirement, and OSHA's current approach to regulating respiratory protection may be best understood in light of it.
From page 460...
... As it emphasizes, OSHA's existing approach to regulating workplace respiratory protection is dominated by a sharply bifurcated level of protection for different workplaces, depending upon whether OSHA has found that its Respiratory Protection Standard requires the workplace to have a respiratory protection program (RPP)
From page 461...
... (2) OSHA regulations and guidance addressing respiratory hazards at workplaces without RPPs (including voluntary programs at OSHA)
From page 462...
... in the Centers for Disease Control and Prevention (CDC) NIOSH was created alongside OSHA in the OSH Act of 1970.70 The primary statute empowering NIOSH for purposes of workplace use of respiratory protection remains the OSH Act, which allocates significant research authority to NIOSH, even as it tasks OSHA with standard setting and implementation.71 While NIOSH does not directly regulate any use requirements for respiratory protection in the workplace,72 as part of its research role, it is empowered to "develop and establish recommended occupational safety and health standards" on the basis of its research and analysis, which OSHA then has the authority to implement.73 NIOSH also plays a critical role in oversight of the development and approval of respiratory protective gear in occupational settings, as described in Part I.A.2.
From page 463...
... NACOSH serves an advisory role to the secretary of labor and the secretary of health and human services on matters related to administration of the OSH Act.76 NACOSH is a 12-member body composed of representatives of management, labor, occupational safety and occupational health professions, and the public.77 All support for NACOSH is provided by OSHA, and NACOSH submits reports and advice via OSHA.78 While NACOSH does not have either rulemaking or enforcement authority of its own, it provides input on workplace safety and health issues, and feedback on existing initiatives under the OSH Act to improve worker safety and health.79 Periodically, NACOSH identifies subcommittees and work groups dedicated to particular issues.80 Most of NACOSH's past recommendations have been relatively minor -- for example, recommending that OSHA and other agencies fund a symposium81 or supporting OSHA's existing attempts at rulemaking.82 Nevertheless, because it is a permanent, nondiscretionary advisory committee, with a close advisory connection to OSHA, NACOSH provides a durable 74 See 29 U.S.C.
From page 464...
... Recall that federal agencies have the responsibility of managing their own occupational safety and health standards for their own workplaces.84 These must generally meet the same standards as private employers.85 Many agencies coordinate with OSHA and NIOSH for such standards, including regarding respiratory protection for their workers.86 The second way OSHA standards are displaced is via the issuance of federal occupational safety and health standards by an agency other than OSHA, regarding a hazard or workplace over which that agency has statutory authority.87 Recall here that the OSH Act provides that agencies displace OSHA standards when they prescribe or enforce standards or regulations affecting occupational safety or health against hazards under their jurisdiction.88 Whether or not particular occupational safety or health standards displace OSHA standards in any particular situation, as against any particular hazard, in any particular workplace, is a surprisingly opaque question, and is often litigated.89 The resulting mosaic of occupational safety and health regulations is difficult, if not impossible, to describe in its entirety. Nevertheless, agencies other than OSHA have authority to regulate respiratory protection outside their own workplaces at least some of the time.
From page 465...
... EPA has substantial authority to regulate a number of environmental inhalation hazards, some of which arise in workplaces. When EPA issues occupational safety and health standards under its statutory authority, these standards displace OSHA protections that would otherwise apply.
From page 466...
... Under FIFRA, EPA is authorized to regulate not just pesticides in general, but also specifically the exposures of pesticide handlers and farmworkers in the field.103 Because the OSH Act prohibits OSHA from regulating working conditions or hazards when other federal agencies exercise statutory authority to issue occupational safety and health standards,104 EPA's authority displaces OSHA's for this set of workplace hazards. 99 For additional treatment of where EPA's statutory authority extends to occupational hazards, see Todd Aagaard, Regulatory Overlap, Overlapping Legal Fields, and Statutory Discontinuities, 29 VA.
From page 467...
... The best example of this may be the coordination between EPA and OSHA/NIOSH on the regulation of asbestos in the workplace.113 In the case of asbestos, OSHA is authorized to set workplace safety standards under the OSH Act,114 whereas EPA's authority arises under the Toxic Substances Control Act (TSCA) , 105 Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C.
From page 468...
... Other agencies have statutory authority that displaces OSHA in regards to particular workplaces, and the inhalation hazards presented at those workplaces. The chief example of this type is MSHA, the successor to the Bureau of Mines, whose responsibilities regarding respirator safety actually pre-date the OSH Act.120 The primary statute empowering MSHA is the Federal Mine Safety and Health Act, which requires MSHA to establish mandatory health and safety standards for "coal and other mines."121 The purpose of the Act was to create a comprehensive regulatory scheme for preventing mine accidents and diseases caused by the occupation of mining.122 To this end, the statute directs MSHA to set standards that are structurally quite similar to those set by OSHA -- "to set standards which will most adequately assure on the basis of the best available evidence that no miner will suffer material impairment of health or functional capacity even if such miner has regular exposure to the hazards dealt with by such standard for the period of his working life"123 -- but again, specifically for mines.
From page 469...
... That said, the OSH Act establishes a complex system of "cooperative federalism" that leaves significant space for states to participate in governing workplace safety pursuant to federal constraints. As a result, many states administer their own occupational safety and health programs via OSHA-approved State Plans.
From page 470...
... Most notably, it declares that "nothing in this chapter shall prevent any State agency or court from asserting jurisdiction under State law over any occupational safety or health issue with respect to which no [federal] standard is in effect."130 This provision preserves state authority in areas that have not been regulated by OSHA or that the OSH Act does not reach -- though it is worth noting that the provision has also been interpreted by the Supreme Court to implicitly preempt state regulation where OSHA has promulgated standards.131 This means that states are permitted to regulate regarding occupational safety and health where OSHA has not acted, but precluded from such regulation where OSHA is deemed to have issued a standard.
From page 471...
... a State Plan has special relevance for whether state and local government workers are protected by RPPs or an equivalent. The OSH Act explicitly exempts state and local government workers from OSHA standards,139 so state and local government workers are not automatically covered by RPPs or other OSHA standards.140 In places with State Plans, workers -- including state and local government workers -- have protections at least as effective as OSHA standards regarding respiratory hazards in the workplace.141 There are currently 22 approved State Plans covering private and public state and local government workers, and 6 State Plans covering only state and local workers.142 Third 134 See Gade v.
From page 472...
... . These states' occupational safety and health is directly regulated by OSHA under the OSH Act and is subject to exemptions (such as those for state and local government workers)
From page 473...
... ii. Workers protected by an authority other than OSHA As noted above, the OSH Act exempts many workers from OSHA protection.
From page 474...
... (1) (indicating OSHA's current interpretation that "self-employed individuals are not covered by the OSH Act or this regulation")
From page 475...
... 1974) (discussing the legislative history of the OSH Act and noting that federal authority over occupational safety and health is as broad as the Commerce Clause)
From page 476...
... Where a statute is ambiguous, courts generally grant the agency that administers the statute broad discretion in choosing how to interpret the ambiguous term.156 Agencies are even free to change their interpretations of the same term over time, and -- so long as the agency's interpretation is reasonable -- even to adopt different interpretations of the term than those that courts would adopt.157 Because of their circularity, the definitions of both "employer" and "employee" in the OSH Act are notably ambiguous, affording OSHA substantial discretion in deciding who qualifies for protection under the Act.158 In some cases, OSHA appears to have used this discretion to adopt a narrow interpretation that excludes some workers from protection. For example, OSHA's decision to exclude domestic workers from protection appears to be a product of its own interpretive choices; the OSH Act itself is silent regarding the status of domestic workers.159 OSHA has also long excluded self-employed persons from the requirements of the Act,160 apparently choosing to presume that self-employed persons are not "employers" because they have no "employees," rather than treating self-employed persons as employers of themselves.
From page 477...
... i. The general authority of NIOSH under the OSH Act regarding development, approval, marketing, and postmarket surveillance NIOSH was created under the OSH Act of 1970, which grants NIOSH the authority to "develop and establish recommended occupational safety and health hazards."164 Such recommendations are made to OSHA, which then has the authority under the OSH Act to implement and enforce them.
From page 478...
... , a division of NIOSH RHD is a division within NIOSH dedicated to conducting research and administering service programs to prevent occupational respiratory diseases and improve workers' respiratory health.168 RHD administers a series of programs that help in identifying workplace inhalation hazards and in surveilling worker health. RHD's role in hazard identification is largely implemented through its Health Hazard Evaluation (HHE)
From page 479...
... (2) Role and activities of NPPTL While NIOSH as a whole is dedicated to generating and implementing new knowledge in the field of occupational safety and health, NPPTL is specifically tasked with addressing the safety and adequacy of personal protective technologies (PPTs)
From page 481...
... 196 NAT'L INST. FOR OCCUPATIONAL SAFETY & HEALTH, CA 2021-1032, Conformity Assessment Letter to Manufacturers 3–5 (Feb.
From page 482...
... . 205 See Memorandum of Understanding Between the Food and Drug Administration/Center for Devices & Radiological Health and the Centers for Disease Control & Prevention/National Institute for Occupational Safety & Health/National Personal Protective Technology Laboratory, MOU 225-18-006 (Dec.
From page 483...
... The NRC is the coordinating agency for incidents at or caused by nuclear facilities.212 In the event of a radiological release, the NRC is specifically responsible for providing recommendations for protective actions at nuclear facilities and for performing postincident surveillance and monitoring.213 FEMA has the authority to assert an expanded role over respiratory protection in workplaces during emergencies and natural disasters.214 When emergencies present respiratory hazards -- as with COVID-19, wildfires, and radiological disasters -- FEMA has a coordinating role that can affect the oversight of respiratory protection in the workplace.215 FEMA also has the authority to play a role in emergency distributions of respiratory protection to workers and the 207 See, e.g., U.S. FOOD & DRUG ADMIN., Emergency Use Authorization for Imported, Non-NIOSH Approved Disposable Filtering Facepiece Respirators (Mar.
From page 484...
... Even states with active state occupational safety agencies, such as California, routinely refer to NIOSH standards in setting requirements for occupational respiratory protection.218 c. Stockpiling Generally speaking, questions of supply chains and national stockpiling strategy are outside the scope of this background paper.
From page 485...
... " that are "approved by the National Institute for Occupational Safety and Health … and that the Secretary determines to be a priority for use during a public health emergency" from federal and state contract and tort liability) ; see also 42 U.S.C.
From page 486...
... While occupational respiratory hazards have centralized authorities in the National Institute for Occupational Safety and Health (NIOSH) (for addressing occupational oversight)
From page 487...
... EPA is empowered by statute to regulate a variety of environmental inhalation hazards facing the public.228 This subsection describes EPA's authority and current practice regarding the use of public respiratory protection under two of the most important of these statutes -- the Clean Air Act and the Toxic Substances Control Act (TSCA) -- and provides a briefer overview of EPA's authority under other statutes.
From page 488...
... .234 EPA is tasked with different responsibilities and different authority regarding each of these types of pollutants. In this sense, the Clean Air Act requires a different regulatory approach for inhalation hazards posed by criteria pollutants and those posed by hazardous air pollutants.
From page 489...
... , ozone, and sulfur oxides.237 To implement the NAAQS, the Clean Air Act relies upon a cooperative federalist structure that assigns significant authority to states to develop State Implementation Plans (SIPs) for achieving the NAAQS that have been set by EPA.238 SIPs are subject to review by EPA, which has the authority to replace them with Federal Implementation Plans (FIPs)
From page 490...
... HAPs are pollutants that are "known or suspected to cause cancer or other serious health effects, such as reproductive effects or birth defects, or adverse environmental effects."246 Congress established an initial list of 189 pollutants, to which EPA has the authority to add; these include substances such as asbestos, benzene, vinyl chloride, and mercury when those substances are airborne.247 The approach used to control HAPs differs from the approach the Clean Air Act uses for criteria pollutants. While control of criteria air pollutants relies on the cooperative federalist partnership between the states and EPA, the HAP regime empowers EPA to directly regulate emissions sources of HAPs, on the theory that the dangers posed by inhalation of such pollutants are so severe that they justify more direct federal control.248 Under the 1990 Amendments to the Clean Air Act, EPA has two mechanisms for controlling HAP emissions: setting technology-based standards for controlling emissions from HAP sources and implementing a health-based standard as a backstop.
From page 491...
... (4) EPA's practice regarding the regulation of inhalation hazards from air pollution The Office of Air and Radiation within EPA is the office responsible for implementing the Clean Air Act and thus the office with primary authority for managing inhalation hazards from air pollution.257 Most of the Office of Air and Radiation's attention and resources are focused on source control.
From page 492...
... AGENCY, EPA-600/8-87-031, EPA INDOOR AIR QUALITY IMPLEMENTATION PLAN 3 (1987) (noting that the Clean Air Act "gave EPA authority to control a wide variety of air emissions sources and air pollutants that contributed to the degradation of ambient air," which EPA has interpreted "to apply to outdoor air only," and that "the quality of indoor air was not addressed in the law")
From page 493...
... Finally, in part because of its administration of the gargantuan Clean Air Act, EPA has substantial expertise about inhalation hazards, on which it is empowered to build to issue guidance and/or to provide public information.
From page 494...
... 279 While these regulations applied specifically to workplace exposures, TSCA itself does not limit EPA's authority to workplace environments.280 Indeed, EPA's past coordination with OSHA to apply use protections to state and local workers helps illustrate the broader reach of EPA's authority under TSCA, particularly in comparison to OSHA's reach under the Occupational Safety and Health Act (OSH Act)
From page 495...
... § 2608. 285 See 1,3-Butadiene; Decision to Report to the Occupational Safety and Health Administration, 50 Fed.
From page 496...
... (4) Characterizing EPA's approach under TSCA EPA is the primary authority for regulating inhalation hazards from environmental sources and has collected substantial expertise regarding exposure and hazards presented by various air pollutants and toxic substances.
From page 497...
... i. CDC's statutory authority regarding inhalation hazards and public health CDC is a national public health agency whose mission is to "serve[]
From page 498...
... NIOSH is an agency within CDC. While NIOSH operates within CDC, however, it is primarily empowered via the OSH Act, as discussed in more detail above.304 The statutory authority of NIOSH, which was created under the OSH Act, is directed toward workers rather than the public.305 Indeed, NIOSH's mission, goals, and objectives are limited to occupational settings.306 Notably, and consistently with this limitation, NIOSH's certification systems -- such as those implemented by the National Personal Protective Laboratory (NPPTL)
From page 499...
... For example, NIOSH developed a program to respond to the respiratory hazards presented by the terrorist attacks of September 11, 2001, focusing on the respiratory hazards and needs of first responders regarding chemical, biological, radiological, and nuclear agents, and has been granted special statutory authority to provide special programs to support health and safety research for World Trade Center survivors (including members of the public) .309 Finally, and as discussed further subsequently,310 NIOSH/NPPTL's respirator certification program for occupational safety and health is routinely used as a touchstone for other agencies when they are making recommendations to the public about respiratory safety and health.
From page 500...
... Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) identifies FEMA's statutory authority for most federal disaster response activities, as well as establishing the presidential disaster declaration process.320 Under the Stafford Act, FEMA is 314 See CTRS.
From page 501...
... , to establish procedures for FEMA to allocate materials, services, and facilities during emergencies, and for deciding which orders and contracts (e.g., of respirators) to prioritize over others.324 For example, in May 2020, during the early coronavirus pandemic, FEMA sent personal protective equipment (PPE)
From page 502...
... Agencies with at least some authority over some inhalation hazards would include agencies whose statutory authority extends to methods of public conveyance, including divisions of the Department of Transportation, such as the Federal Aviation Administration327; and agencies that have authority over particular inhalation hazards, such as the Nuclear Regulatory Commission's responsibilities regarding nuclear hazards.328 Other agencies provide information that is used by the public in identifying which respiratory protection to use; OSHA's Safety and Health Information Bulletins on respiratory protection, for example, are sometimes recommended to members of the public seeking respiratory protection.329 Still others recommend the use of respiratory protection under some circumstances; for example, the Consumer Product Safety Commission (CPSC) recommends respirator use to the public when using hazardous products, though it typically refers back to OSHA standards and NIOSH certification when making those recommendations.330 In addition, in the absence of legislation creating a comprehensive system for public respiratory protection, the executive branch has substantial authority to issue "gap-filling" enforcement and executive actions to require respiratory protection for the public in those areas where there is federal jurisdiction.
From page 503...
... Variation in state laws addressing public respiratory protection have been particularly salient during the coronavirus pandemic. While no state has issued public mandates for respirators -- that is, respiratory protection that would protect wearers from airborne infection -- many states have issued "mask mandates" requiring face covering.332 The specific requirements, duration, and enforcement of these mandates has varied by state.333 Generally speaking, however, management of source control through mask mandates is legally justified by states' "police power," which gives them authority over matters of general public safety,334 and by states' authority to declare and enforce quarantine within their borders.335 Such power is particularly broad where, as is the case with the coronavirus pandemic, no federal action (such as action by the surgeon general to "prevent the introduction, transmission, or spread of communicable diseases from … one State or possession into another State or possession"336)
From page 504...
... Torts are civil wrongs, and can arise when a wrong by one person or company causes harm to another.341 Torts generally arise out of state law, and are often adjudicated in state courts.342 In some cases, specific rules in tort have been codified by state legislators via state statutes.343 In most cases, however, tort law has been created via judge-made common law, which has developed over decades of case law and through the creation of judicial precedent.344 In environmental and public health contexts, tort law acts as a backstop for the types of proactive regulatory standards that this paper has discussed thus far.345 It provides an additional set of incentives for manufacturers and sellers of respirators and other protective gear, and thus forms a part of the regulatory landscape that can affect what actions firms and individuals take in 338 See CDC, Notice: Severe Acute Respiratory Syndrome (January 20, 2004) (explaining CDC's general approach to managing the spread of Severe Acute Respiratory Syndrome [SARS]
From page 505...
... Fraud is discussed in more detail in the subsequent subsection, as it bears particularly on state law oversight of respiratory protection.347 Products liability is an area of law that seeks to ensure that products are reasonably safe.348 Products liability is "strict," in that product designs or manufacturing defects that cause people harm trigger liability for any damage that is caused.349 As a result, in many cases, designers, manufacturers, and sellers of protective gear, including respirators, can be liable in products liability if their products cause harm to others -- even if the product was designed and manufactured according to regulatory standards such as those set by NIOSH for N95 respirators.350 There is ongoing scholarly debate over whether stringent state liability regimes promote or deter the safe manufacture and sale of protective devices.351 In some cases, scholars have suggested that robust state products liability regimes could stymie innovation and availability of public respiratory protection, and/or that existing judicial doctrines of preemption -- which thus far have generally352 allowed for state tort claims in products liability even where the product otherwise complies with product safety statutes or administrative regulations353 -- should be reconsidered in the case of respiratory protection.354 Thus far, however, tort liability remains a 346 See note 345; see also Victor E Schwartz, Cary Silverman and Christopher E
From page 506...
... The result is that some members of the public -- notably, children -- may not be served even by agencies' general recommendations about the type of respiratory protection to use against inhalation hazards. In the absence of comprehensive federal action on public respiratory protection, state and local law also plays a role in the use, provision, and availability of respiratory protection for the public, although this role varies by state and by hazard.
From page 507...
... of the FD&C Act to regulate face masks and respirators when they meet the statutory definition of a medical "device."361 Within FDA, the Center for Devices and Radiological Health is the division that implements rules and requirements regarding medical devices.362 FDA has long had special responsibilities regarding the regulation of adulterated or misbranded devices.363 Generally speaking, devices are "adulterated" if they include filthy, putrid, or decomposing substances; if they are packed under unsanitary conditions; or if their manufacturer violates performance standards or good manufacturing practices. And they are misbranded if they are labeled in a false and misleading matter; if its packaging does not bear required labels, including directions for use; or if it is dangerous to health when used in the 357 See Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C.
From page 508...
... During the coronavirus pandemic, FDA has claimed authority under the FD&C Act to regulate all face masks, shields, and respirators that are used for a medical purpose, including N95 respirators used to prevent infection with the COVID-19 virus.370 The same respirators are not considered "devices" when they are intended for a nonmedical purpose, such as for use in construction.371 Under current FDA classifications, face masks that are not surgical masks are regulated as Class I devices,372 and thus are not subject to performance standards or postmarket 364 See 21 U.S.C. § 351; see also General Controls for Medical Devices, U.S.
From page 509...
... is developed for multiple uses, only some of which are medical. FDA only claims jurisdiction over devices when their purpose is medical, as with the prevention of disease.374 Many inhalation hazards -- including environmental hazards -- can produce diseases such as cancer; however, it can be difficult to determine just how far FDA's authority reaches.
From page 510...
... .379 It is relevant to inhalation hazards that the public may face as the result of exposure to products, such as household cleaning agents. It also plays a limited role in regulating some forms of face coverings against flammability risk.
From page 511...
... have sometimes partnered with other agencies (such as EPA) in addressing risks from inhalation hazards that apply both inside and outside workplaces,392 neither NIOSH nor OSHA has the unilateral statutory authority to develop standards or to develop oversight programs for nonoccupational contexts.393 Though NIOSH/NPPTL's authority is constrained to occupational safety and health, its expertise is often leveraged by other actors and has occasionally been used by Congress in specific public health emergencies.
From page 513...
... State and local authorities Generally speaking, states have authority to regulate development, approval, marketing, and/or postmarketing surveillance of public respiratory protection only where federal action has not precluded state action. States are precluded, for example, from engaging in oversight functions that would interfere with FDA's oversight over respiratory protective devices that are used for medical purposes.404 Where there is no comprehensive federal scheme, however, states have substantial gap-filling authority.
From page 514...
... The agency with the most significant authority is FDA, although its oversight authority is limited to respiratory protection used for "medical purposes." Several other federal entities -- including CDC and CPSC -- serve some oversight function against specific respiratory hazards. Often, however, even these entities refer members of the public to NIOSH certifications, which were developed for occupational uses and for workers.
From page 515...
... Even more than the prior part of the paper, this part focuses on the federal regulatory landscape. Perhaps needless to say, directions regarding state law should be directed toward states.
From page 516...
... Sample Forms of Action Congress Legislative  Able to expand (or  Passing a new statute (e.g., constrain) agency regarding inhalation hazards)
From page 517...
... existing expertise to  Shifting resource allocation (e.g., issue nonbinding by devoting additional resources guidance and other to inhalation hazards or information. respiratory protection)
From page 518...
... These examples are provided for purposes of clarification only and are not meant to advocate for or against any specific set of substantive recommendations by the Committee. Generally, recommendations to Congress are a particularly good institutional fit when the remedy suggested would require a change to existing agencies or to those agencies' statutory authority, or to the appropriations and other resources assigned to specific agencies.
From page 519...
... and the National Institute for Occupational Safety and Health (NIOSH) regarding the regulation of workplace safety (including inhalation hazards)
From page 520...
... As the head of the executive branch, the President has significant authority over the way that most agencies implement and enforce the statutes that they administer.429 For agencies within the executive branch, presidential authority is particularly robust; the President may, for example, fire the heads of executive agencies for any reason at any time, including because the President dislikes the agency's implementation of the President's policy priorities.430 Independent agencies, created by Congress outside the executive branch, have some insulation from presidential oversight -- most notably, the heads of independent agencies are not removable by the President at will431 -- though they remain subject to some limited forms of executive authority.432 As chief executive, the President has a number of mechanisms for centralizing executive review of agency action433 and for encouraging cross-agency cooperation, including by issuing executive orders directing cooperation and/or prioritizing management of respiratory hazards, creating interagency working groups, and/or elaborating or amending existing presidential plans, such as the COVID-19 response plan.434 These functions can be used to coordinate multiple agencies, particularly where there are overlaps in existing authority of those agencies. Presidents also have the authority to direct creation of a new agency, and in fact they have done so many times over the past decades.435 Two limitations on this authority are worth noting, however.
From page 521...
... Such priorities could be directed either toward improving respiratory protection in general, as with the creation of an interagency working group directed toward improving and coordinating provision and development of respiratory protection for the public, or could address particular respiratory hazards. In regards to particular respiratory hazards, the President has significant authority in issuing specific plans and orders, particularly when directed toward emergencies such as the 438 See Howell and Lewis, 2002, p.
From page 522...
... itigate spread through expanding masking, testing, treatment, data, workforce, and clear public health standards,"442 and seeks "to implement a cohesive strategy to significantly reduce the spread of COVID-19 and release clear public health guidance to the public about what to do and when, including implementing mask mandates," as well as other methods.443 Recommendations on how to further detail these recommendations to address respiratory protection as the Committee understands it would be reasonably addressed to the President, who obviously would have the authority to implement those recommendations under the plan if he or she so chose. Similarly, the Committee might make recommendations directly to the President about the best type of respiratory protection to require in instances where the executive has authority to mandate use of masks or respiratory protection.
From page 523...
... .448 Courts affect agency actions via judicial review, which is most commonly directed toward ensuring that an agency has not exceeded its statutory authority, has used appropriate procedure, and/or that the agency has not acted arbitrarily.449 Agencies do not have Constitutional authority of their own and may never act beyond the authority that has been granted them by law.450 Where statutes are ambiguous or leave gaps, however, agencies are typically granted broad discretion to interpret the statutes they administer, so long as their interpretations are reasonable and do not fly in the face of congressional direction.451 Because of this -- and despite the forms of control otherwise imposed by Congress, the President, and courts -- agencies often have significant leeway in determining the policy choices that they believe to be best. Committee recommendations directed toward agencies can therefore have important power to persuade among varying permissible interpretations.
From page 524...
... 218 (2001) (explaining that the Skidmore standard applies to agency actions that lack the "force of law")
From page 525...
... .459 Notably, recommendations to agencies by the National Academies can have particularly significant legal implications not only in potentially persuading an agency to use its discretion to act,460 but also in the event that agency action is challenged in court.461 Specifically, while agencies have substantial authority in setting their own priorities and in interpreting statutes they administer, courts will overturn agency actions if they are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."462 As the Supreme Court has explained, "[n] ormally, an agency rule would be arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise."463 National Academies recommendations can particularly affect whether courts view agencies as having failed to consider an important aspect of a problem or to have addressed the evidence before the agency.464 In this sense, recommendations that comment on an important aspect of a problem that an agency needs to address, or that characterize existing evidence, can also be understood as particularly relevant to agency action and thus to the agencies that may read the Committee's report.
From page 526...
...  Coordinating with other agencies For example, a recommendation that the Environmental Protection Agency (EPA) revisit its existing interpretations of statutes, such as the Toxic Substances Control Act and the Clean Air Act, to adopt the broadest permissible interpretations of its statutory authority to protect the public from inhalation hazards could be reasonably addressed to EPA rather than Congress.
From page 527...
... In some cases, it can be difficult to tell the far extent of an agency's statutory authority, and agencies may sometimes have adopted narrow interpretations without even recognizing that they have broader authority. EPA, for example, might believe that it is precluded under the Clean Air Act from regulating indoor respiratory hazards.


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