Frameworks for Protecting Workers and the Public from Inhalation Hazards (2022) / Chapter Skim
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7 Respiratory Protection Oversight and Guidance for the Public
7 Respiratory Protection Oversight and Guidance for the Public
Pages 323-370
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From page 323... ...
The chapter begins with consideration of different options for a coordinating entity in this framework that would be charged with integrating the efforts of all stakeholders to ensure that the various functions are carried out seamlessly to meet the public's respiratory protection needs broadly -- those of both the general population and members of population groups that are vulnerable to specific hazards. This discussion builds on the examples of coordination models discussed in Chapter 5.
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From page 324... ...
As a result, the current landscape of respiratory protection for the public is substantially more complicated to address relative to that of occupational respiratory protection, with considerable fragmentation across multiple federal and state authorities and gaps in critical authorities, particularly as relates to conformity assessment and approval of respiratory protective devices. Stakeholders and authorities may vary depending on whether the hazard is an infectious agent, such as SARS-CoV-2, or an environmental hazard, such as wildfire smoke, as well as on where the exposure occurs (e.g., in a transportation or business environment, indoors or outdoors)
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From page 325... ...
State, territorial, and State, territorial, and tribal governments have significant tribal governments authority over matters of public safety. These authorities enable state governments to issue so called "mask mandates" requir ing the use of respiratory protective devices by the public for purposes of source control.
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From page 326... ...
Nongovernmental organizations may be involved in conformity assessment, including standards development and device testing. Regarding the use of respiratory protective devices, private businesses (e.g., grocery stores)
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From page 327... ...
Moreover, such a model could isolate respiratory protective devices from more upstream primary prevention efforts and create an additional barrier to exchange, integration, and communication. The committee therefore views the hub-and-spoke model as the preferable path forward to address the need for a coordinating entity within a broader structure designed to ensure adequate and effective respiratory protection for the public.
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From page 328... ...
In particular, there are missing authorities that need to be addressed, -1 Figure 8-1) F2 Determine Necessary Respiratory Con and Protective Devices tinu rning ou sI a mp e Le r l ov yc Lead ec Agency em Lif en t F1 F3 Assess Hazard Ensure Availability and Determine Need and Access Pathways for Respiratory Lead Agency Coordinating Lead Agency for Respiratory Protection Entity Protective Devices rate Lead orpo Lead Agency Agency Inc F5 F0 F4 Develop and Engage, Inform, and Approve Respiratory Ensure Access for Protective Devices Target Community FIGURE 7-1 A hub-and-spoke model for coordination related to respiratory pro tection for the public.
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From page 329... ...
, but both have lesser responsibilities and expertise related to inhalation hazards and respiratory protection relative to HHS and EPA. EPA has substantial regulatory authorities related to environmental hazards, but a far less prominent role when inhalation hazards are infectious agents, excepting the guidance it develops for indoor exposure to
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From page 330... ...
Moreover, the coordinating entity would have to be able to respond to hazards at a pace that reflects the urgency of the need for respiratory protection. During the COVID-19 pandemic, CDC has been slow to respond to rapid advances in scientific evidence (Tanne, 2020) , including the evidence clearly documenting airborne transmission of SARS-CoV-2 by aerosols (NASEM, 2020; Samet et al., 2021)
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From page 331... ...
Pending such congressional action, the White House should establish an interagency task force focused on respiratory protection for the public to ensure that the activities of the interim HHS office are coordinated with other stakeholder federal agencies. Of note, while this coordinating entity should be focused on the respiratory protection needs of the public, coordination with OSHA on respiratory protection issues that overlap with the needs of workers is critical to reducing the potential for conflicting messages and confusion and ensuring a seamless system for the nation.
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From page 332... ...
DEFINING RESPONSIBILITIES AND ADDRESSING GAPS IN AUTHORITIES RELATED TO THE FRAMEWORK FUNCTIONS As discussed in Chapter 2, the regulatory and legal landscape with respect to oversight of nonoccupational use of respiratory protection is extraordinarily complex, with both gaps and overlaps in the authorities related to the key functions of the committee's framework (described in Chapter 5)
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From page 333... ...
The committee's assessment of the necessary capabilities and oversight authorities of stakeholders for each function and its consideration of potential stakeholders that might fill current gaps are discussed in the following sections. Function F0: Develop and Approve Respiratory Protective Devices Massive wildland fires in the western United States and the COVID-19 pandemic have underscored the public's need for access to appropriate respiratory protection.
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From page 334... ...
The conformity assessment component of this program will need to ensure the quality, effectiveness when used outside of a respiratory protection program, and appropriate labeling of respiratory protective devices to be used by the public. 1 1 Americans with Disabilities Act of 1990 as amended by the ADA Amendments Act of 2008 (Public Law 110-325)
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From page 335... ...
Advantages of this approach include harnessing its unique capabilities in respiratory protection (e.g., conformity assessment and respirator research) built within NPPTL over the past two decades.
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From page 336... ...
. Necessary characteristics of a lead oversight agency: Expertise in respiratory protection, including standards development, conformity assessment processes, and certification models, as well as market forces and incentives related to product development; access to testing laboratories and standards develop ment organizations; regulatory authority for device approval and for enforcement mechanisms that enable taking corrective action for nonconforming products (including recall authority)
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From page 337... ...
FDA may not have the necessary expertise related to standards development, however. • CPSC -- Has established processes for ensuring that consumer products meet standards and has enforcement authorities, but lacks expertise in respiratory protection.
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From page 338... ...
, and mold from flooding events, among others, will require a system for identifying and assessing hazards, evaluating exposure and risk, and determining the need for respiratory protection. This core function is complex because of the diversity of inhalation hazards faced by the public and the potential need for a range of scientific expertise to assess them. CDC has various systems and a formalized process for identifying new infectious disease outbreaks, but its process for evaluating risk for the public and generating specific public health recommendations regarding the need for public use of respiratory protection is fragmented and ad hoc.
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From page 339... ...
However, incident command structures are inherently temporary and hazard specific, and therefore not well suited to the development of forward-thinking and formalized processes for considering inhalation hazards faced by the public or the public's respiratory protection needs. Moreover, reliance on CDC's occupational safety and health experts for the substantial task of addressing the public's respiratory protection needs could distract from the important focus of such groups on the needs of workers.
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From page 340... ...
Addressing Gaps in Responsibilities and Authorities To protect the public health from the diverse inhalation hazards of concern, a coordinating entity is needed to oversee the compilation of existing knowledge on exposure and risk; gather input from experts; and guide the public, including specific subgroups, on the need for respiratory protection, accounting for alternative strategies (e.g., other control methods, such as social distancing and vaccination) and potential health risks of using respiratory protective devices. This core function will require coordination across multiple agencies, based on the relevant scientific and administrative expertise of each agency and the nature of the inhalation hazard in question (Shaffer, 2021)
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From page 341... ...
as a starting point, followed by more comprehensive reviews. Any system broadly addressing respiratory protection for the public would differ from EPA's process for establishing the NAAQS in other important ways. Whereas the NAAQS process is limited to specific air pollutants, the coordinating entity for respiratory protection for the public would need to regularly survey existing and emerging hazards that might trigger that need.
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From page 342... ...
-- Has authorities under the Clean Air Act and Toxic Substances Control Act to regulate a variety of envi ronmental inhalation hazards facing the public, but there is no clear EPA authority to manage the majority of those hazards through respiratory protective devices. EPA does provide guidance to the public on respira tory protection against some environmental hazards (e.g., wildfire smoke, indoor mold)
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From page 343... ...
Approach 2: Each lead agency performs hazard/risk evaluations and makes recommendations to the coordinating entity on the public's need to use respiratory protective devices within the context of the full range of possible interventions. • This approach would require agencies conducting assessments to also have expertise in respiratory protection but could make it easier to link guidance on respiratory protection to hazard/risk evaluations (e.g., using the Air Quality Index for EPA)
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From page 344... ...
The coordinating entity should oversee each of the steps in this process and engage stakeholders with the relevant expertise to perform the scientific review and risk evaluation, and use this information to inform evidence-based decisions on the need for public use of respiratory protective devices. Function F2: Determine the Necessary Respiratory Protective Devices Once it has been determined that an inhalation hazard faced by the public warrants the use of respiratory protection, recommendations on specific devices will need to be matched to the nature of the hazard and guidelines developed regarding their use.
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From page 345... ...
Current market-driven approaches for the development, manufacture, and marketing of respiratory protective devices rely heavily on the regulatory model for occupational respiratory protection in that devices are manufactured with the knowledge that their use will be required in certain industries to perform certain tasks. Thus, manufacturers have a guaranteed market.
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From page 346... ...
Addressing Gaps in Responsibilities and Authorities Current processes for generating recommendations on devices meeting the public's needs for respiratory protection are ad hoc and often rely on collaborative relationships among multiple federal stakeholders. Needed is a formalized and enduring process and structure with a clear BOX 7-3 Necessary Stakeholder Capabilities and Oversight Authority Options for Function F2 Overall coordinating entity role: Provide a mechanism for ensuring that hazard assessments conducted by agencies with the appropriate hazard-specific exper tise (see Function F1)
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From page 347... ...
Addressing gaps in oversight authorities (options with considerations for each) : Approach 1: Designate an existing agency as lead to make recommendations to the coordinating entity on the respiratory protective device best meeting the needs of the public based on the hazard and risk evaluation, with potential leads and considerations being the same as those identified for Function F0 (i.e., the National Personal Protective Technology Laboratory [NPPTL]
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From page 348... ...
Recommendation 7-6: Use Hazard and Risk Evaluations to Determine the Necessary Respiratory Protective Devices for the Public The laboratory called for in Recommendation 7-4 should use the haz ard and risk evaluations generated through the standardized process de scribed in Recommendation 7-5 to identify and make recommendations to the coordinating entity on approved respiratory protective devices that best meet the respiratory protection requirements of the public. When no approved device exists that meets the identified requirements, the laboratory should oversee efforts to address this gap, consistent with its role in Function F0.
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From page 349... ...
. This governmental marketplace will be needed until the concept of respiratory protection for the public is embraced, and the public actively seeks out such devices and includes them in disaster supply kits for use during infectious disease, wildfire, and air pollution events.
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From page 350... ...
The coordinating entity would be tasked with monitoring and guiding federal efforts to manage the supply chain so as to ensure adequate supplies of respiratory protective devices to meet public needs (e.g., providing input to those with the authority to invoke the DPA or working with manufacturers to incentivize production)
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From page 351... ...
. To prepare for the occurrence of a large-scale incident involving inhalation hazards and ensure an adequate supply of respiratory protective devices in the event of such an incident, the entity should also work with the White House and the Federal Emergency Management Agency, as well as manufacturers, re garding the need to trigger the Defense Production Act and to provide incentives for manufacturing the necessary devices, especially during public health emergencies.
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From page 352... ...
, including purchasing and distribution; relationships with manufacturers and with state, local, tribal, and territorial authorities that may be responsible for distributing respiratory protective devices; expertise in supply chain management and understanding of diverse population needs related to device access. Current agencies with some oversight authorities related to this function: The Department of Health and Human Services (HHS)
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From page 353... ...
responsible for ensuring access pathways could have reduced visibility on the supply chain as compared to approach 2, requiring close coordination with the coordinating entity. Approach 2: Lead agency interfaces with ASPR/PHEMCE regarding the sup ply chain for respiratory protective devices and ensures access pathways.
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From page 354... ...
The public's needs for clear and timely guidance are addressed by the functions of the coordinating entity and result in outcomes that support the public's effective use of respiratory protective devices.
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From page 355... ...
Thus a critical gap is the lack of formal requirements or mechanisms for public health agencies and health care providers to be trained in respiratory protection so they can be confident in evaluating resources to which they can direct their patients. In addition to communication pathways, the form and content of health messages influence their effectiveness.
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From page 356... ...
Addressing Gaps in Responsibilities and Authorities Multiple federal agencies develop and disseminate guidance for the public on the selection and use of respiratory protection based on the nature of the inhalation hazard at hand. For example, EPA, which regulates environmental pollutants and provides air monitoring data, has produced guidance for public health officials on protecting the public from wildfire smoke, which includes the use of respiratory protective devices (EPA et al., 2019)
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From page 357... ...
This guidance and training should address which respiratory protective devices should be used, when they should be used, and how they should be worn to reduce harm from inhalation hazards. The coordinating entity should facilitate the engagement of and gathering of input from key stakehold ers to advance these efforts, and ensure that the approaches developed consider the needs, cultural and socioeconomic factors, and local con texts of vulnerable groups and those facing persistent health burdens.
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From page 358... ...
EPA provides guidance to the public on respiratory protection (particularly for wildfire smoke)
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From page 359... ...
• The laboratory proposed in Recommendation 7-3, which would be charged with oversight of standards development for and approval of respiratory protective devices for the public, develops the guidance and training. This approach could create redundancy in infrastructure and lack of clarity re garding roles and responsibilities.
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From page 360... ...
• CDC should partner with medical and public health professionals and societies, as well as device manufacturers and retailers, to de velop, test, and disseminate training modules and guidance appropri ate for health care and public health professionals and community health workers so they will be prepared to provide guidance to and respond to questions from the public about health risks associated with inhalation hazards and respiratory protective devices. • If CDC is made aware of the spread of misinformation, it should de velop and disseminate improved versions of the guidance to counter such misinformation.
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From page 361... ...
Function F5 also serves as the pathway to activating Function F0 (e.g., product design, standards development, conformity assessment, and manufacturing) when the need for a respiratory protective device to protect the public against an inhalation hazard has been identified.
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From page 362... ...
• Track and analyze technological advances related to respiratory pro tection, and work with relevant stakeholders in using these advances to improve existing and create new respiratory protective devices for the public. • Create a roadmap for the future of respiratory protection for the public, and institute processes for ongoing updating of the roadmap to keep it robust and responsive to evolving inhalation hazards and technological advances.
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From page 363... ...
Necessary characteristics of a lead oversight agency: Infrastructure for research, as well as for monitoring and evaluation for ongoing improvement purposes; expertise in specific hazards of interest, respiratory protection, sociobe havioral science, implementation science, and continuous improvement Current agencies with some oversight authorities related to this function: The Environmental Protection Agency, the Centers for Disease Control and Pre vention, the National Institutes of Health (e.g., the National Institute of Environ mental Health Sciences) , and the Department of Homeland Security all have relevant research programs.
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From page 364... ...
BOX 7-7 Consolidated Roles for the Coordinating Entity Across Functions Function F0 (Develop and approve respiratory protective devices) : Ensure that information from ongoing scenario planning and research on user needs informs design requirements that feed into standards development and guides the development of new respiratory protective devices.
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From page 365... ...
: Monitor the availability of respiratory protective devices and facilitate interfaces among existing authorities related to the supply chain, manu facturers, and the lead agency responsible for access pathways by which the public acquires these devices. Function F4 (Engage, inform, and ensure access for the target community)
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From page 366... ...
2021. Discussion at the October 6, 2021, public meeting of the National Acad emies of Sciences, Engineering, and Medicine Committee on Respiratory Protection for the Public and Workers Without Respiratory Protection Programs at Their Workplaces, virtual.
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From page 367... ...
2021. Discussion at the October 6, 2021, public meeting of the National Acad emies of Sciences, Engineering, and Medicine Committee on Respiratory Protection for the Public and Workers Without Respiratory Protection Programs at Their Workplaces, virtual.
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From page 368... ...
2021. Presentation at the July 9, 2021, 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.
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From page 369... ...
Department of Health and Human Services. https://thinkculturalhealth.hhs.gov/ clas/standards (accessed October 7, 2021)
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