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1 Introduction
Pages 37-78

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From page 37...
... 4 Respiratory Protection Individuals in the United States and Americans abroad are exposed to inhalation hazards from a variety of sources -- some in workplaces, some for the Public indoors, and some outdoors -- and these hazards can have short- and longterm adverse effects on health. For example, exposure to wildfire smoke, 37
From page 38...
... . Furthermore, some individuals, including children, the elderly, and people with underlying health conditions, are at heightened risk of adverse health outcomes associated with inhalation hazards (American Lung Association, 2020b; CDC and HUD, 2006)
From page 39...
... . Target populations are the public and groups of workers not covered by an RPP; these groups include some worker populations that face occupational exposures to inhalation hazards and arguably should be covered by an RPP (e.g., some wildland firefighters, home care workers)
From page 40...
... Regula tory approaches to meeting respiratory protection needs will be explored for a broad range of workers who may need to use respiratory protective devices in the absence of a respiratory protection program, as well as for the general public, including vulnerable populations such as children, the elderly, and people with respiratory or cardiovascular disease. Specifically, the committee will: 1.
From page 41...
... Outdoor workers, including day laborers and other workers with temporary/informal occupational arrangements (e.g., agricultural workers) Indoor workers, including those with formal or temporary/ informal occupational arrangements (e.g., grocery (wildfire smoke)
From page 42...
... In meetings with the committee, the study sponsors clarified that the focus of the study was not limited to respirators, but also included masks and face coverings. Respirator is the term used in this report to describe personal devices designed to protect the user from the adverse effects of inhalation hazards.
From page 43...
... the workplace so as to effectively assess, control, and evaluate inhalation hazard exposures for workers. The regulatory landscape for respiratory protection is described in detail in Chapter 2.
From page 44...
... These PAPRs do not require fit testing and can accommodate wearers with facial hair For the purposes of this report, with the notable exception of dust masks3 (or nuisance masks) , masks are personal devices designed and intended to reduce the spread of infectious agents found in large droplets, such as those from saliva, sneezes, and coughs.
From page 45...
... are unfitted devices that may provide some protection against contamination of the surrounding environment by their wearers by reducing the amount of infectious agents released during exhalation, coughing, or sneezing. Surgical/medical masks may also provide some protection to the user against liquid splash and droplets, but they are not tested or intended as protection from inhalation hazards as they are not designed to fit tightly to the face.
From page 46...
... As described above, personal devices designed to reduce exposure to inhalation hazards may be used for personal protection and/or to protect others (i.e., source control)
From page 47...
... for source control limits the proper selection of respirators, masks, face coverings, and barrier face coverings based on the hazard because the hazard arises from being in proximity to an infected individual or in an airspace containing infectious aerosol. The ongoing COVID-19 pandemic and widely visible wildfire smoke, often present at unsafe levels, have heightened the public's awareness of various personal devices used to reduce exposure to these inhalation hazards, although likely not the distinctions among the devices that are often based on technical specifications and standards as described above.
From page 48...
... STUDY CONTEXT Inhalation Hazards and Their Contribution to the Burden of Disease An understanding of how exposures to inhalation hazards occur in occupational or general environmental settings is critical for the design of respiratory protection strategies. Consistent with its charge, while acknowledging the important contribution of regulated workplace exposures to the burden of disease in the United States, the committee did not conduct a review of common and well-characterized occupational inhalation hazards (e.g., silica, coal dust)
From page 49...
... Exposure to inhalation hazards can lead to an array of adverse health outcomes, contributing to, causing, and exacerbating respiratory illnesses and increasing risk for such conditions as cardiovascular disease and cancer, among others (Bowe et al., 2019; EPA, 2019)
From page 50...
... . In the United States, 100,000– 200,000 excess deaths every year are attributable to air pollution, a figure that does not include the burden caused by wildfire smoke (Thakrar et al., 2020)
From page 51...
... . Biological, Chemical, and Radiological Inhalation Agents Biological, chemical, and radiological agents are significant inhalation hazards faced by the public and workers not covered by RPPs.
From page 52...
... . By contrast, smaller-sized aerosols have a greater propensity to follow air flows, thus requiring a respiratory protective device with a tighter seal to protect the airways and a better filtering capacity than what a surgical mask can provide to ensure proper protection (Tellier et al., 2019)
From page 53...
... i CDC, 2019. Chemical and radiological inhalation hazards are less frequent causes of public health disasters compared with biological hazards but can be extremely harmful to human health and the environment.
From page 54...
... . Current Approach for Providing Respiratory Protection in the United States As discussed previously, the use of respiratory protection in the United States has historically been associated with occupational settings in which workers are exposed to defined inhalation hazards -- for example, health care workers exposed to tuberculosis, firefighters exposed to smoke, and miners exposed to coal dust and silica (NIOSH, 2019)
From page 55...
... The conduct of hazard and exposure assessments to determine which hazards are present and the potential for exposure forms the basis for understanding the effectiveness of different control strategies and is the first step in ensuring people's protection. In workplaces where measures higher in the hierarchy of controls are insufficient to reduce hazardous exposures to known inhalation hazards and PPE in the form of respirators becomes necessary to protect the health
From page 56...
... Thus, while OSHA sets and enforces standards for use of respirators in workplaces to ensure safe and healthful working conditions, NIOSH -- a research agency within CDC focused on occupational safety and health -- establishes and enforces performance standards for respirators for workers. While some inhalation hazards are limited primarily to specific occupational settings, others, such as wildfire smoke, ambient air pollution, and respiratory viruses, may be ubiquitous, with exposures not limited to the workplace.
From page 57...
... As discussed below, this approach had to build on a foundation of concepts of risk and how it can be reduced. Illustrative examples of inhalation hazards, most notably related to wildfire smoke and COVID-19, are woven throughout the report to ground the discussion in real-world scenarios requiring the use of respiratory protection.
From page 58...
... When elimination, engineering, administrative, and other controls are not feasible or available, effective respiratory protective devices should be available for the public as well as all workers. • A framework for respiratory protection should incorporate a sys tems approach, given the diverse processes (e.g., hazard identifi cation and assessment, product design and manufacturing, device selection and use)
From page 59...
... A further imperative for respiratory protection comes from the severity of the potential adverse outcomes. The goal of respiratory protection, regardless of who is using it, is to reduce the risk of adverse responses to inhaled agents.
From page 60...
... However, for the populations -- workers not covered by an RPP and the public -- that are the targets of this study, the specificity that characterizes the OSHA and MSHA programs is lacking; the agents of concern and the circumstances of exposure are broad and not readily specifiable; the populations affected are diverse and varying in demographic characteristics, vulnerability,9 and susceptibility;10 and exposures and risks may not be readily quantified. With regard to the committee's charge, an overall goal of any new respiratory protection system is to reduce risk from inhalation hazards to an acceptable level.
From page 61...
... have been long-standing, while others, such as airborne infectious agents and wildfire smoke, are emerging with greater intensity and are likely to become more frequent and severe. Moreover, exposure profiles are likely to vary in time, place, and intensity.
From page 62...
... The first is the committee's development of a framework of authorities and responsibilities, central to its charge, which required consideration of complex and interdependent roles, processes, and resources of stakeholder organizations. The second application relates to the committee's review of the evidence on factors that influence the effectiveness of respiratory protective devices, as measured by reduced exposures and risk of adverse health outcomes from inhalation hazards, along with associated gaps.
From page 63...
... Approach to the Development of the Committee's Frameworks In developing and defining its frameworks, the committee • evaluated other frameworks and systems in place (e.g., National Planning Frameworks for National Preparedness, Public Health Emergency Medical Countermeasures Enterprise) to ensure the health and safety of the nation during unforeseen events, such as terrorist incidents and natural disasters; • applying the set of guiding principles presented above, identified the key characteristics or capabilities required to ensure access to and effective use of respiratory protective devices while overcoming the shortcomings of the current system, as enumerated in the conclu sions presented in Chapters 2 through 4; • identified the current stakeholders, if any, engaged in carrying out activities to evaluate inhalation hazards and ensure the availability and effective use of respiratory protective devices; • explored the potential to expand the existing responsibilities and authorities of these current stakeholders to carry out the necessary activities in the committee's proposed frameworks and associated challenges, if any; and • identified a set of key strategic, organizational, regulatory, and op erational factors important to ensuring successful implementation of the proposed frameworks.
From page 64...
... FIGURE 1-5  A system model depicting factors that influence the effectiveness of respiratory protective devices. This model shows the many interrelated factors that function within the system of respiratory protection.
From page 65...
... Gaps and needs related to guidance are discussed in Chapters 3 and 4 for workers not covered by RPPs and the public, respectively, and draw on the findings from the literature reviews and an assessment of existing guidance related to inhalation hazards faced by these populations, including SARS-CoV-2 and wildfire smoke. However, the development of guidance for specific inhalation hazards was beyond the scope of the committee's charge.
From page 66...
... . An initial matrix, which was provided by the sponsors, included six different populations of interest and five different sets of agents, some comprising complex mixtures (e.g., ambient air pollution and wildfire smoke)
From page 67...
... . The findings from the comprehensive reviews identify factors that influence the effective use of respiratory protection within the contexts of specific use scenarios, as well as many gaps where further research is needed.
From page 68...
... Committee meetings held in November 2020, January 2021, July 2021, and October 2021 included public information-gathering sessions that provided an opportunity to hear from various stakeholders, including worker populations; representatives of national, state, local, and tribal public health agencies; manufacturers of respiratory protective devices; and federal agencies with oversight responsibilities and authorities related to respiratory protection and/or inhalation hazards (see Appendix A for all public meeting agendas and description of the committee's deliberative process)
From page 69...
... INTRODUCTION 69 including core functions, stakeholder responsibilities, and the authorities necessary to address current gaps in the nation's system for oversight of respiratory protection. In Chapters 6 and 7, the committee explores the application of this general framework in frameworks specifically targeting workers and the public, respectively, and presents recommendations designed to ensure access to and effective use of respiratory protective devices by these two populations.
From page 70...
... Occupational Safety Respirator means a type of personal protective equipment (PPE) that is certified and Health Adminis- by the National Institute for Occupational Safety and Health (NIOSH)
From page 71...
... The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests. Surgical masks are generally regulated by FDA as Class II devices under 21 C.F.R.
From page 72...
... ASTMd A barrier face covering is a product worn on the face, specifically covering at least the wearer's nose and mouth, with the primary purpose of providing source control and a degree of particulate filtration to reduce the amount of inhaled particulate matter.
From page 73...
... Presentation at the January 25, 2020, public meeting of the National Academies of Sciences, Engineering, and Medicine Committee on Respiratory Protection for the Public and Workers Without Respiratory Protection Programs at Their Workplaces, virtual. https://www.nationalacademies.org/event/01-25-2021/respiratory-protection-for the-public-and-workers-without-respiratory-protection-programs-at-their-workplaces committee-meeting-3 (accessed September 27, 2021)
From page 74...
... 2021. Cardiovascular health impacts of wildfire smoke exposure.
From page 75...
... 2015. A systematic review of the physical health impacts from non-occupational exposure to wildfire smoke.
From page 76...
... 2016. Critical review of health impacts of wildfire smoke exposure.
From page 77...
... 2014. Non-accidental health impacts of wildfire smoke.


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