Frameworks for Protecting Workers and the Public from Inhalation Hazards (2022) / Chapter Skim
Currently Skimming:
2 The Regulatory Landscape for Respiratory Protection
2 The Regulatory Landscape for Respiratory Protection
Pages 79-126
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 79... ...
. The chapter also describes conformity assessment processes for respiratory protection and the challenges and limitations of current for the Public approaches.
|
From page 80... ...
Other federal agencies, including the Environmental Protection Agency (EPA) , have authority over specific inhalation hazards and in specific workplaces.
|
From page 81... ...
if it finds that the inhalation hazards faced by those workers pose a "significant risk." OSHA also has the authority to issue emergency temporary standards requiring respiratory protection against such threats if it determines "that employees are exposed to grave danger from exposure," and that the emergency temporary standard is "necessary" to reduce the danger.9 In June 2021, OSHA implemented an emergency temporary standard for health care workers to address COVID-19 risk. It has also issued multiple enforcement response plans during the pandemic10 and directed implementation of a National Emphasis Program (NEP)
|
From page 82... ...
Training of personnel in the inhalation hazards to which they are poten tially exposed and in the proper use of respirators 8. Procedures for maintenance (cleaning, disinfecting, repairing)
|
From page 83... ...
. Other agencies have statutory authority that displaces OSHA's with regard to particular workplaces and the inhalation hazards those workplaces present.
|
From page 84... ...
. Conclusion 2-1: OSHA's ability to ensure that the respiratory protec tion needs of all workers are met is constrained by outdated statu tory language and interpretations that limit the applicability of its Respiratory Protection Standard to workers employed in traditional employer–employee relationships and by statutory language that dis places its authority where occupational safety and health are regu lated by another government agency.
|
From page 85... ...
For example, California has promulgated two regulations that specifically address inhalation hazards and controls, including respirators for wildland fire smoke and for aerosol transmissible diseases (see Boxes 2-2 and 2-3, respectively)
|
From page 86... ...
• Respiratory protection: Provide National Institute for Occupational Safety and Health (NIOSH) -approved respirators to all employees, and encourage their voluntary use.
|
From page 87... ...
if certain conditions are met (FDA, 18 Respiratory Protective Devices Used in Healthcare, 79 Fed.
|
From page 88... ...
The ATD Standard applies most directly to workplaces and operations where workers may face an elevated risk of exposure to aerosol transmissible diseases, including hospitals and acute care facilities, skilled nursing facilities, emergency medical services, and some public health operations, as well as correctional facili ties, homeless shelters, drug treatment programs, and laboratories that handle aerosol transmissible pathogens. (Medical settings such as primary care clinics and medical offices, dental practices, long-term care facilities, and school-based clinics have limited requirements under the standard since they are not designed to diagnose or treat patients with airborne infectious diseases.)
|
From page 89... ...
are the minimum level of respiratory protection required, although certain high hazard procedures may require use of powered air-purifying respirators or other higher levels of protection. Employers at facilities with employees facing potential occupational exposure to airborne infectious diseases are required to adopt all components of a respiratory protection program as outlined in California's Division of Occupational Safety and Health Standards Board (Cal/OSHA)
|
From page 90... ...
approved" and published on the "Certified Equipment List." The en abling regulation for respirator conformity assessment is 42 C.F.R. § 84, titled "Ap proval of Respiratory Protective Devices." However, the Occupational Safety and Health Administration (OSHA)
|
From page 91... ...
EPA EPA has authority to regulate some inhalation hazards faced by the public, although that authority is limited to environmental hazards, such as those resulting from exposure to toxic chemicals or air pollution, and it is not always clear how much authority the agency has to manage those hazards via respiratory protection. The Clean Air Act and the Toxic Substances Control Act, both administered by EPA, give the agency most of its authority in this realm.
|
From page 92... ...
performs and coordinates applied research on a number of environmental hazards, including inhalation hazards; engages in public communication and education; and takes part in public health emergency training (CDC, 2021a)
|
From page 93... ...
. Authorities Regarding Development, Approval, and Marketing of Respiratory Protective Devices for Use by the Public In the absence of an equivalent to NPPTL for nonoccupational settings, no single federal entity is responsible for overseeing the development, approval, marketing, or postmarketing surveillance of respiratory protective devices for the public, or for generating or overseeing a conformity assessment program for managing these processes.
|
From page 94... ...
To address the risk of adverse skin reactions, FDA recommends evaluating biocompatibility using FDA guidance. Labeling is to include the information required in the NIOSH approval, as well as additional information including proper selection, use, seal check, maintenance, and disposal (FDA, 2007)
|
From page 95... ...
. In environmental and public health contexts, tort law can provide additional incentives for manufacturers and sellers of respirators and other protective gear, thus forming part of the regulatory landscape that can affect the actions taken by firms and individuals with regard to manufacturing, selling, and marketing of respiratory protective devices for the public28 (Schwartz et al., 2009)
|
From page 96... ...
Conformity assessment programs exist for a wide variety of products, including medical devices; aircraft; nuclear reactors; and personal protective equipment (PPE) , such as helmets and respirators.
|
From page 97... ...
. Organizations with roles in the conformity assessment process include • manufacturers and suppliers whose products are assessed; • standards-development organizations, governmental or private sector, that provide product performance requirements and test procedures; • testing organizations that evaluate products and provide test reports; • certification organizations that manage the process of third-party certification; • accreditation organizations that audit and determine the competence of testing and certification bodies; and • government agencies that oversee conformity assessment processes and mandate the use of standards and conformity assessment in regulation.
|
From page 98... ...
framework. The figure shows the input activities for CA, which include identifying hazards and risks, identifying PPE types needed, and identifying standards to address these hazards, and the direct activities, which include defining the CA requirements and performing CA activities based on the input activities.
|
From page 99... ...
. In contrast with other PPE types, the conformity assessment processes for respiratory protective devices is comparatively regimented.
|
From page 100... ...
. As there is no equivalent user fit testing program for the public, the lack of a fit test during the conformity assessment process contributes to problems with public use of FFRs approved by NIOSH for workers.
|
From page 101... ...
This flow chart illustrates the multiple steps in the NIOSH respirator approval process, from receipt of the devices by the manufacturer, to application for approval, to associated fees, to preparation of the certificate for approval. 101 SOURCES: D'Alessandro and Peterson, 2020; NASEM, 2021.
|
From page 102... ...
Prior to ASTM F3407-20, there were no consensus or govern ment standards for testing the fit capability of a filtering facepiece respirator (FFR) , despite lengthy and unsuccessful efforts by the National Institute for Occupational Safety and Health (NIOSH)
|
From page 103... ...
. Conformity Assessment for Nonrespirator Masks and Face Coverings FDA 510K requirements for surgical masks Surgical masks -- also called dental or medical masks -- are cleared for marketing through FDA's 510(k)
|
From page 104... ...
The conformity assessment process for barrier face coverings follows ASTM Guide F3050, Annex A3, Model A, which outlines requirements for design, performance, labeling, and user information. The standard also requires barrier face coverings to be tested by an accredited laboratory for • submicron particle filtration efficiency, and • airflow resistance.
|
From page 105... ...
,32 signed into law in 1996, required government agencies to use voluntary consensus standards to the extent possible, and directed the National Institute of Standards and Technology (NIST) to eliminate unnecessary duplication by coordinating the conformity assessment activities of federal, state, and local entities with private-sector activities on technical standards and conformity assessment.
|
From page 106... ...
. Some of these organizations develop test specifications, while others develop standards that include requirements for conformity assessment.
|
From page 107... ...
The United States employs a "license to use" model for respirators, whereby a respirator must meet set requirements for use in an RPP, and OSHA requires employers to select these respirators from the NIOSH Certified Equipment List. Thus, responsibility for ensuring that NIOSHapproved respirators are used falls on the employer.
|
From page 108... ...
. The potential mismatch between standards and use may be particularly relevant when respiratory protective devices are used by the public for protection from a variety of hazards (e.g., wildfire smoke and SARS-CoV-2)
|
From page 109... ...
OVERSIGHT OF THE SUPPLY CHAIN FOR RESPIRATORY PROTECTIVE DEVICES The supply chain for respiratory protective devices in the United States is part of a global marketplace, driven by supply and demand. Most respirators are sold through distributors -- safety specialist and industrial distributors for industrial users and medical distributors for respirators used in health care.
|
From page 110... ...
and other medical materiel, including respiratory protective devices (NASEM, 2016)
|
From page 111... ...
The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) , led by ASPR, is a federal interagency group established by HHS that is charged with determining which items make up the SNS formulary38 based on a review of material threat determinations (CDC, 2014; Gerstein, 2020; NASEM, 2016)
|
From page 112... ...
Authorities Related to Distribution of Respiratory Protection FEMA, the federal agency responsible for managing critical response to national emergencies, has an expanded role in respiratory protection during emergencies and natural disasters. When emergencies present inhalation hazards, as with COVID-19, wildfires, and radiological disasters, FEMA has a coordinating role that can affect the oversight of respiratory protection in both occupational and nonoccupational settings.
|
From page 113... ...
As evidenced by the scarcity of N95 FFRs throughout most of 2020 and as seen in previous pandemics and epidemics, global supply chains and just-in-time manufacturing undermine the nation's ability to respond to sudden surges in demand. N95 FFRs are currently manufactured in multiple countries worldwide.
|
From page 114... ...
. Additionally, the inherent challenges involved in producing certain respiratory protective devices, such as FFRs, that require molding during the manufacturing process can cause bottlenecks due to the expense and time demands of the molding process.
|
From page 115... ...
In April 2020, the language on its website text changed. Until then, the website stated: The Strategic National Stockpile is the nation's largest supply of life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out....
|
From page 116... ...
Despite increased production and imports, 12 months following the first recorded COVID-19 case in the United States, N95 FFRs were still difficult to come by for both health care workers and the public. Medical
|
From page 117... ...
. Conclusion 2-6: The SNS was inadequate to meet needs for respira tory protective devices during the COVID-19 pandemic.
|
From page 118... ...
2014. National conformity assessment principles for the U.S.
|
From page 119... ...
2019. The respirator fit capability test: Enhancing the efficacy of filtering facepiece respirators.
|
From page 120... ...
2020. Conformity assessment procedures for protective equipment.
|
From page 121... ...
2017b. Memorandum of understanding between the Food and Drug Administration/ Center for Devices & Radiological Health and the Centers for Disease Control & Preven tion/National Institute for Occupational Safety & Health/National Personal Protective Technology Laboratory, MOU 225-18-006.
|
From page 122... ...
2020. ISO/IEC 17000:2020 conformity assessment -- Vocabulary and general principles.
|
From page 123... ...
2017. National frame work for personal protective equipment conformity assessment -- Infrastructure.
|
From page 124... ...
A-119, federal participation in the development and use of voluntary consensus standards and in conformity assessment activities. Federal Register 81(17)
|
From page 125... ...
2021. Information request for NPPTL on respirator conformity assessment.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.