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Summary
Pages 5-36

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From page 5...
... Citations for the discussion presented in the Summary appear in the subsequent report chapters. 2  Respiratory protection broadly describes any approach designed to reduce exposure to hazards that can be inhaled (i.e., inhalation hazards)
From page 6...
... The full charge to the committee is presented in Chapter 1 of this report. As a result of the ongoing COVID-19 pandemic and widely visible wildfire smoke, often at levels exceeding the National Ambient Air Quality Standards for particulate matter, the public has become increasingly aware of various devices intended for use in reducing the adverse effects of inhalation hazards.
From page 7...
... However, for the purposes of this report and the com mittee's frameworks as described herein, the term respiratory protective device is used to describe any personal device that provides protection against inhalation hazards when used effectively. This function-based definition acknowledges that each device may offer either personal protection or source control or both at vary ing levels.
From page 8...
... These interconnected systems for approving respiratory protective devices for use in workplace RPPs and for generating requirements and guidance on their use are grounded in the science of exposure assessment and understanding of the risks posed by specific hazards. While exposure limits may be lacking for some workplace inhalation hazards, data can generally be collected with regard to concentrations and durations of exposures.
From page 9...
... In places with State Plans, workers -- including state and local government workers -- are supposed to have protections "at least as effective" as OSHA standards regarding inhalation hazards in the workplace. State and local government workers in 24 states and the District of Columbia, the Northern Mariana Islands, Guam, and American Samoa are not covered by OSHA standards or by OSHA-approved State Plans.
From page 10...
... In the absence of comprehensive federal regulation, significant authority regarding the use of respiratory protective devices by the public is left to the states. Although the states may receive guidance from federal agencies, there is no formal system for coordinating the development and distribution of such guidance to state and local health agencies or the public.
From page 11...
... that are not intended to be used as respiratory protective devices in the workplace and thus are currently subject to no certifying body or formal oversight designed to ensure that the devices are effective for their intended use. The lack of a comprehensive regulatory framework makes it difficult to understand the level of protection provided by a product against a known or unknown inhalation hazard, especially given the challenges of ensuring proper fit for individuals across a population with considerable physical and demographic heterogeneity and the sociobehavioral considerations that impact access to and effective use of a device (e.g., attitudes and beliefs, safety culture)
From page 12...
... NOTE: See Box S-2 for definitions of these core functions. Nonetheless, although some level of risk remains even with use of available devices, respiratory protection decreases the risk for harms to health from inhalation hazards, and when details of a hazard are known, appropriate respiratory protection should decrease risk to a level considered acceptable based on structured evaluation of the risk.
From page 13...
... Use of the term "respiratory protective device" in the function titles makes clear that the general framework includes the functions of both personal inhalation protection and source control. It is important to note as well that the framework is intended to evolve and be sustained over time, and to be agile in anticipating and responding to new threats that may emerge in the future.
From page 14...
... Function F1: Assess hazard and determine need for respiratory protection Function F1 encompasses the ongoing monitoring and assessment of hazards to determine whether there is a need for respiratory protection, considering first whether the hazard can be adequately mitigated through other measures higher in the hierarchy of controls. Function F2: Determine the necessary respiratory protective devices In Function F2, the hazard assessment from Function F1 is used to determine the protective devices that best meet the respiratory protection needs posed by the hazard.
From page 15...
... coordinating entity for the development, functioning, oversight, evaluation, and continuous improvement of its proposed framework for ensuring that workers not currently covered by RPPs are adequately protected from inhalation hazards. In its role as coordinating entity, OSHA, in partnership with NIOSH, would need to consult with other federal agencies as well as state and local agencies, as appropriate, when those agencies have regulatory authority over employers or are charged with recommending workplace health protections.
From page 16...
... Act to clarify the definitions of employer and employee such that OSHA has the authority necessary to ensure respiratory protection for all types of workers, including all private-sector workers, over whom OSHA currently does not exercise its authority. Revised language in the Act should make clear that persons and entities conducting a business have a primary duty and thus are required to ensure, to the extent reason ably practicable, that the health of their workers -- as well as that of other workers influenced or directed by the business, consumers, and the public -- is not put at risk by inhalation hazards resulting from the business's activities.
From page 17...
... Act to ensure that the Occupational Safety and Health Administration's (OSHA's) respiratory protection requirements apply to all private-sector employers and workers facing inhalation hazards, or OSHA expands its definitions of employer and employee to cover all private-sector workers, states should require employers to protect workers who are not currently under OSHA jurisdiction from inhala tion hazards through the passage of new laws or promulgation of new regulations.
From page 18...
... Respirator Conformity Assessment Processes NIOSH should expand its National Personal Protective Technology Laboratory to improve the timeliness and surge capacity of its respi rator conformity assessment processes. In doing so, NIOSH should (1)
From page 19...
... Most workers are not covered by an RPP or by mandatory workplace safety standards addressing the use of respiratory protection. Yet recent experiences with worsening and novel, unanticipated threats, such as wildfire smoke and SARS-CoV-2, point to the potential need to introduce respiratory protection measures at an expanded number of worksites when inhalation hazards exist and other control measures are not feasible.
From page 20...
... While Recommendation 6-4 focuses on particulate matter and airborne infectious disease agents as high-priority targets for comprehensive exposure standards, the committee recognizes that standards for many other inhalation hazards faced by workers are outdated or lacking. Protecting workers without RPPs from inhalation hazards will require a more expansive effort to establish or update workplace exposure standards.
From page 21...
... -approved Respirators in Guid ance for Workers Facing Inhalation Hazards When other forms of control (e.g., engineering, administrative) fail to protect workers from inhalation hazards, the Occupational Safety and Health Administration and other agencies with authority over worker safety (e.g., Environmental Protection Agency, Mine Safety and Health Administration, Department of Energy)
From page 22...
... Recommendation 6-6: Prepare to Meet Expanded Worker Respiratory Protection Needs The Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health should undertake an eval uation to understand and predict the potential scope of the increased need for respiratory protection associated with the expansion of worker coverage and the risk of future large-scale incidents or situations in volving inhalation hazards (environmental and infectious agents)
From page 23...
... 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. Recommendation 6-7: Support the Development of Targeted and Tai lored Guidance and Training for Workers The National Institute for Occupational Safety and Health, the Occu pational Safety and Health Administration, the Environmental Protec tion Agency, the National Institute of Environmental Health Sciences, and other relevant federal agencies should expand grant programs and other support mechanisms to facilitate the translation of existing tech nical information on respiratory protection into tailored and culturally appropriate guidance and training materials designed for workers, particularly those who may be using respirators outside of a respiratory protection program.
From page 24...
... , NIOSH should launch expanded surveil lance and intramural and extramural research programs to better un derstand and meet the needs of all workers facing inhalation hazards. The surveillance program should generate data on the population sizes and characteristics, exposures to inhalation hazards and associated risks, and respiratory protection needs of these workers, including workers with disabilities, other underserved populations, and volun teers.
From page 25...
... and Authorities to Protect the Public from Inhalation Hazards While largely centralized oversight authorities for occupational inhalation hazards exist in NIOSH and in OSHA, there is no corollary structure in the context of public protection, and there are gaps in critical authorities, particularly related to conformity assessment and approval of respiratory protective devices. Stakeholders and authorities may vary depending on whether the hazard in question is an infectious agent, such as SARS-CoV-2, or an environmental hazard, such as wildfire smoke, as well as on where
From page 26...
... to provide a unified and authoritative source of informa tion and effective oversight in the development, approval, and use of respiratory protective devices that can meet the needs of the public and protect the public health. Given the urgent need for action, the Secre tary of HHS should immediately establish an interim office to take on priority near-term tasks of the coordinating entity until Congress acts to establish the coordinating entity.
From page 27...
... In contrast with NIOSH/NPPTL for occupational settings, no federal entity is responsible for overseeing the development, approval, marketing, and postmarketing surveillance of all respiratory protective devices for the public, or for generating or overseeing a conformity assessment program that would manage these processes. Current devices used by the public in the face of inhalation hazards are a mix of NIOSH-approved industrial respirators, medical and nuisance dust masks, and a variety of other commercial and homemade face coverings.
From page 28...
... Function F1: Assess hazard • Hazard monitoring • Access to a multidisciplinary and determine need for • Hazard and exposure group to monitor the hazard, respiratory protection assessment conduct hazard assessment, and judge the acceptability of • Risk evaluation and hazard risks control • Hazard monitoring infrastructure Function F2: Determine • Respiratory protection: • Relationships with the necessary respiratory hazard-based assessment manufacturers protective devices and determination of level of • Access to the Certified protection Equipment List • Product development, including knowledge of market forces and incentives Function F3: Ensure • Supply chain management • Relationships with availability and access • Understanding of diverse manufacturers pathways for respiratory population needs related to • Relationships with state, local, protective devices access to respiratory protective tribal, and territorial authorities devices responsible for distributing devices • Access to Strategic National Stockpile (SNS) information • Authorities related to the SNS, including purchasing and distribution
From page 29...
... Recommendation 7-4: Establish a Capability to Oversee Standards Development for and Approval of Respiratory Protective Devices Used by the Public Congress should mandate that the Department of Health and Human Services establish and adequately resource a laboratory responsible for overseeing standards development, conformity assessment, and ap proval for respiratory protective devices intended for use by the public, as described for Function F0. Two approaches could be taken to establishing the necessary capability, each with pros and cons such that the committee did not identify one as preferable to the other: (1)
From page 30...
... Current processes for generating recommendations on devices to meet the public's needs for respiratory protection are ad hoc and often rely on collaborative relationships among multiple federal stakeholders. Needed is a formalized and enduring process and structure with a clear lead organization responsible for determining which existing respiratory protective devices best meet the needs of the public based on evaluation of the particular hazard and risks (Function F2)
From page 31...
... . 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.
From page 32...
... To be effective in this role, they need to be equipped with a level of knowledge that will enable them to support members of the public in selecting, fitting, using, and caring for respiratory protective devices that will help protect them from inhalation hazards. There are currently no formal requirements or mechanisms for health care and public health professionals to be trained in respiratory protection, a gap that needs to be addressed.
From page 33...
... CDC should map the reach of its communications to ensure that they can reach all segments of the population. • CDC should partner with medical and public health professionals and societies, as well as device manufacturers and retailers, to 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.
From page 34...
... 34 PROTECTING WORKERS AND PUBLIC FROM INHALATION HAZARDS Recommendation 7-9: Continuously Evaluate Progress toward Goals, and Enhance the Framework's Operations Based on ongoing monitoring and evaluation, the coordinating entity should • develop and update plans with objective and transparent mile stones and ensure that changes needed to continuously enhance the framework are made; • regularly assess and publicly report on progress; • ensure that available funding and its allocation enable goals to be achieved; • coordinate linkages across partners in government, academia, non profits, and industry; • conduct periodic exercises to evaluate national preparedness for respiratory protection for the public; and • lead the development of a coordinated, strategic research agenda to develop the knowledge base and address knowledge gaps in respiratory protection for the public. COORDINATION BETWEEN THE WORKER AND PUBLIC-FOCUSED FRAMEWORKS As described above, in responding to its charge, the committee developed a general framework for oversight and guidance to meet respiratory protection needs, and from that general framework, frameworks targeted to two broad population groups: workers, including those not currently covered by respiratory protection programs, and the public.
From page 35...
... CONCLUDING THOUGHTS For decades, the nation's systems for ensuring respiratory protection have been focused on a small subset of the U.S. population -- those workers who are exposed to inhalation hazards as an intrinsic consequence of their jobs and for whom RPPs are required by law.
From page 36...
... All workers and the public need to be able to turn to a clear and authoritative source of information on inhalation hazards and how they can protect themselves from those hazards, and a system for providing accurate guidance and support to ensure access to and effective use of respiratory protective devices needs to be in place. Furthermore, the needs and resources of the most vulnerable population groups must be considered.


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