Assessment Pathways for Respiratory Protective Devices for Occupational Use by Nontraditional Workers
Like other health devices, respiratory protective devices (RPDs) are assessed and approved through various regulatory pathways. Most RPD regulations are administered through workplace-specific policies. In a session moderated by planning committee member Howard Cohen of the Yale School of Medicine, three speakers explored how existing conformity assessment (CA) processes align with the health and safety requirements of nontraditional user groups. This session focused on opportunities to develop or support CA processes for RPDs or alternative devices for these user groups and evaluated lessons learned from CA models used outside the United States, by third-party organizations, and in private industry.
Maryann D’Alessandro, the director of the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH), discussed the role that NPPTL plays in the approval and CA processes for respiratory protective devices for occupational use. She said that the mission of NPPTL is to prevent work-related injury, illness, and death by advancing the state of knowledge and application of personal protective technologies and that this is achieved by efforts focused on personal protective equipment (PPE) research, surveillance, CA, outreach, and interventions. The cornerstone of the work done by NPPTL is the NIOSH Respirator Approval Program, which approves all respirators used in workplaces across the United States (see Box 5-1). While NIOSH approves
these respirators for occupational use, the Occupational Safety and Health Administration (OSHA) maintains responsibility for overseeing respiratory protection programs for workplaces that require the use of respirators and worker compliance in accordance with OSHA’s respiratory protection standard, 29 CFR 1910.134.1 In addition, NIOSH approves respirators for use in health care settings by working closely with the Food and Drug Administration (FDA) under a memorandum of agreement published in 2018. NIOSH currently executes these FDA requirements for respirators used in health care settings—fluid resistance, flammability, and biocompatibility—through NIOSH’s respirator approval process. However, she said, manufacturers must still list and register their products as per FDA regulations.
D’Alessandro explained that the responsibilities of NPPTL vary depending on which of its three strategic goals—reducing inhalation hazards, reduc-
1 More information about 29 CFR 1910.134 is available from https://www.osha.gov/lawsregs/regulations/standardnumber/1910/1910.134 (accessed September 16, 2020).
ing dermal hazards, and reducing injury hazards—is in play and that the work of the agency touches on all aspects of respiratory protection in the workplace (see Figure 5-1). NPPTL’s role in reducing inhalation hazards involves leading research and surveillance activities that serve as the basis for the development of both consensus and federal standards as well as serving in a leadership role in the development of these consensus standards and the federal respiratory protection standard, 42 CFR 84.2 Additionally, NIOSH is responsible for leading respiratory protection CA in the United States, including respirator pre-approval and post-approval activities.
Conformity Assessment for Personal Protective Equipment
CA is critical for addressing worker health and safety, D’Alessandro said. CA is defined as the “demonstration that specified requirements relating to a product, process, person, or body are fulfilled.” As described above, NIOSH is responsible for CA for respirators used in occupation settings as enforced by OSHA, and it also approves respirators for use in health care settings. D’Alessandro said that a robust CA program helps to ensure that workers’ health and safety issues are addressed, provides consumers with added confidence in product performance, and gives companies a competitive edge.
2 More information about 42 CFR 84 is available from https://www.cdc.gov/niosh/npptl/topics/respirators/pt84abs2.html (accessed October 9, 2020).
Conformity Assessment Framework
D’Alessandro explained that NPPTL led the development of the National Framework for Personal Protective Equipment Conformity Assessment, which can be applied when identifying the specific exposure hazards in a workplace and determining whether respirators that conform to existing standards can be applied to address the hazard of concern (see Figure 5-2). While this framework is well-suited to occupational uses of respirators, she said that complexities may arise with respect to the unique needs of contingent workers and the general public, for whom respiratory hazards may be less clear. D’Alessandro acknowledged the sentiment expressed during John Balmes’s presentation and others in earlier sessions that “the perfect must not be the enemy of the good,” but she said that “the good” must be good enough to actually provide protection from the hazards in question. She suggested that NIOSH’s scientific and deliberate approach of aligning hazards with an approved product for use in an occupational setting could also ensure that the public and contingent workers are advised to use devices that address the hazards of concern and are safe when used as intended. In cases where no existing standards are appropriate for addressing the hazard of concern, then NIOSH can determine whether a standard should be developed to address that hazard through either the establishment of a new federal standard under 42 CFR 84 or through a consensus standard process. She said that NIOSH aims to ensure that all standards are informed by science and that all hazards are well understood.
Once a standard approach is selected, NIOSH collaborates with its partners to identify a CA method that should be used to execute that standard. In the workplace, D’Alessandro said, this is typically ensured through 42 CFR 84, although there are exceptions. For instance, RPDs used by the fire services are approved by NIOSH through 42 CFR 84, but are also required to meet additional requirements identified through consensus standards developed by the National Fire Protection Association (NFPA). Once the CA approach has been determined, a post-market approach is then established to ensure the products continue to conform to the standards under which they were originally approved and certified.
In conclusion, D’Alessandro said that the changing nature of work has resulted in gaps that directly affect certain workers, such as those who perform their roles outside of a formal respiratory protection program, and this raises questions regarding how other CA approaches could be applied to address these needs. D’Alessandro emphasized that some type of CA is necessary for devices that are used by the public and that NIOSH’s current CA framework (see Figure 5-2) is broadly applicable for understanding how the needs of these new user populations should be aligned with potential processes and approaches. Additionally, it will be essential that key partners are identified and engaged in this evaluative process.
Jeffrey Peterson, the branch chief at NPPTL, described the process and approach used by NIOSH and NPPTL to approve respirators for use in occupational settings, including health care settings. He explained that NPPTL executes NIOSH’s authority to approve respirators under 42 CFR 84 and that two regulatory agencies require the use of NIOSH-approved respirators: OSHA and the Mine Safety and Health Administration. Since its inception, NIOSH has issued more than 9,000 approvals for a variety of types of respirators (see Box 5-1) and currently has 101 approval holders in 15 countries who are manufacturing NIOSH-approved products in 192 manufacturing sites in 26 different countries. He said that NPPTL has improved the quality of the U.S. inventory of respiratory protection for workers in all industry sectors by making 552 respirator approval decisions and completing 254 respirator audit activities in 2019, adding that NPPTL activity has increased in 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic. Between January 2020 and August 2020, NPPTL issued 498 decisions and completed 538 audit activities.
National Institute for Occupational Safety and Health Respirator Approval Process
Peterson described the NIOSH approval process, which begins with the submission of a request for approval that is processed by the receiving/records room. The submission package includes a standard application form, a document package documenting the specifications of the product, fees, and sample hardware needed for evaluation (see Figure 5-3). NIOSH conducts all evaluations—including testing for NIOSH approval—internally. No third-party activities or laboratories are used for the NIOSH evaluation process. Next, an initial engineering review is conducted to (1) confirm the reason for application, (2) review the application content, (3) verify whether the hardware is a new or revised configuration, (4) issue fee estimate, and (5) assign appropriate tests. The product then moves into the dual stages of testing and quality assurance. In these stages, NPPTL (1) conducts the assigned testing, (2) assesses quality management system for conformance to requirements within 42 CFR 84, (3) reviews inspection procedures and ensures that the classifications of defects are consistent with the regulation, and (4) reviews documentation for proper revision level.
The NIOSH approval process concludes with a final engineering review, Peterson said. During this stage, NPPTL reviews test data, updates the NIOSH parts database, reviews and finalizes labeling, and finalizes the approval or denial package. The NIOSH respirator approval process is robust and involves many stakeholders, he said. Figure 5-4 depicts the workflow of the approval process. Nested within each block of the workflow are numerous
additional workflows and decision points. All of these workflows and decision points are intended to maintain the consistency of NIOSH decisions and evaluations throughout the respirator approval process.
National Institute for Occupational Safety and Health Post-Approval Processes
Peterson explained that in addition to pre-approval and issuance of approval, NIOSH is engaged in post-approval activities such as post-approval product audits, post-market evaluation activities, and the Site Audit Program.
Post-Approval Product Audits and Post-Market Evaluation Activities
Peterson described the approach that was used to conduct these post-approval product audits until 2015, when NIOSH’s regulation changed and allowed it to expand the product audit program. Each year, 40 to 50 products were selected for auditing, and each was purchased on the open market. Products might be selected for auditing for a range of different reasons—to investigate a product about which questions or reports had been made, for example, or to determine whether issues had been resolved for a product that had undergone a certified product investigation. After the expansion of the program in 2015, NIOSH developed a decision logic based on the number of product approvals that a company holds. Products are chosen from the certified equipment list for audit using criteria such as respirator type, time since that respirator was last tested, and product problem history. One product per type of respirator product approved is audited each year. Peterson added that the revised audit process has allowed NIOSH to expand its auditing capacity to conduct 140–150 product audits each year, with any test failures resolved through the certified product investigation process. In recent years, purchased products have focused on filtering facepiece respirators. Peterson described NIOSH’s post-market evaluation activities as providing for effective product conformity and use assessments, noting that NIOSH has the regulatory authority to conduct evaluations of the requirements that must be met to maintain product approval.
Site Audit Program
In addition to its product audits, NIOSH’s site audit program ensures manufacturer compliance with approved quality system plans and the respirator performance requirements of 42 CFR 84.3 Peterson said that site
3 Peterson clarified that N95 manufacturing sites are inspected as part of the NIOSH NPPTL approval process.
audits of production facilities are conducted every 2 years and site audits of corporate offices are conducted every 4 years. Audits are typically conducted over 1–2 days, with the length of the audit based on facility size, the number of approvals held by the company operating the site, language barriers, the complexity of respirators being produced, and the audit and field problem history. Peterson outlined three typical outcomes of a site audit: (1) the site is deemed to be acceptable, (2) the site is deemed to be provisionally acceptable, or (3) the site is deemed to be unacceptable. An acceptable site requires no further action, but sites that are deemed provisionally acceptable are required to implement corrective actions. Through NIOSH’s evaluation and testing branches, these corrective actions are followed up. Sites are asked to submit effective evidence that problems have been addressed. In some cases, the implementation of these corrective actions requires the submission of a modification to approval. Thus, the site audit process feeds back into the larger CA program for respirators, and any changes must be evaluated and documented as part of the formal approval record. These site audits help NIOSH ensure that approval holders’ quality, systems, and products continue to meet standards, Peterson said. Additionally, they help approval holders ensure the quality and reliability of respirators and give workers stronger assurance of respirator functionality. Peterson concluded by saying that NIOSH stands apart from other CA processes through NPPTL and the robust respirator approval process.
Jeff Stull, the president of International Personnel Protection, Inc., acknowledged the relatively robust and comprehensive program used by NIOSH to certify and approve respirators. However, he suggested that it is worthwhile to consider other CA approaches that exist to address the needs of nontraditional workers who are using RPDs or workers who are using products that fall outside of existing government regulations on RPDs.
Ideal Personal Protective Equipment Conformity Assessment Approach
Stull reviewed the ideal PPE CA approach that was described by D’Alessandro earlier in the session (NIOSH, 2017) (see Figure 5-2). Broadly, the ideal CA process consists of input activities, direct activities, and a cycle of evaluation and surveillance to continually improve the program. The steps of an ideal CA process include (1) identifying the hazards and risk to workers, (2) evaluating what devices are needed to address these hazards, (3) identifying what standards should be used, (4) defining what processes are needed to ensure that the required level of protection has been met, and (5) performing these CA activities.
Alternative Conformity Assessment Approaches
Stull noted that CA is a large-scale process that includes not only product-based standards, but also standards related to the selection, use, and care of these devices. He provided an overview of four different CA approaches.
European Committee for Standardization Conformity Assessment
The European Committee for Standardization (CEN) is a CA program operating in Europe that establishes basic requirements for directives and regulations related to PPE as well as evaluation for multiple types of respirators.4 Stull said that the European Union has a relatively robust system of standardization across its member nations. In terms of PPE, part of that standardization falls under a key regulation for establishing how CA of PPE is undertaken: 2016/425 (PPE CE Marking).5 The European Union also has a counterpart regulation for the use of PPE that meets the directives of regulations: 2019/1832 (use of PPE), which he described as similar to OSHA requirements for using approved (certified) respirators.6 Stull said that part of the process of establishing CA is to set basic safety and health requirements for different types of PPE. He added that these are very general requirements as part of the hazard needs assessment conducted during the initial stages of the standards development process. Then, as part of CEN’s process of developing standards, specific requirements are established for unique products in terms of the general hazard protection needs. Part of this process includes the classification of risk into three distinct categories associated with different types of PPE. Category 1 includes products with a simple design and lower risk (e.g., gardening gloves). Category 3—which includes most PPE products—includes devices with more complex design and the highest associated risks or consequences for use. As such, Category 3 PPE products also have more stringent requirements for technical documentation, testing, quality control, oversight, and how the declaration of conformity is ultimately provided. Examples of European norms include EN 136 (full facepieces), EN 140 (half and quarter masks), EN 143 (particulate filters), EN 149 (FFRs), and EN 12941 (powered hood/helmet respirators). There is a separate but parallel effort by the International Organization for
5 More information about EU 2016/425 is available from https://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32016R0425&rid=4 (accessed October 9, 2020).
6 More information about EU 2019/1832 is available from https://op.europa.eu/en/publication-detail/-/publication/4edc1256-fbd2-11e9-8c1f-01aa75ed71a1/language-en/formatPDF/source-126627073 (accessed October 9, 2020).
Standardization (ISO) TC94/SC15 on RPDs, he noted. However, typically ISO does not write any type of CA or certification requirements, as it leaves these processes to the independent bodies and nation members of the ISO organization set their own in-country requirements.
National Fire Protection Association Conformity Assessment
NFPA has a CA program that addresses multiple respirators used by first responders and offers a third-party certification that is mandatory in certain settings.7 NFPA has one of the most robust nongovernmental CA processes, Stull said. Like NIOSH, NFPA establishes standards based on an understanding of specific hazards, protection needs, and defined requirements (NFPA, 2016).8 He explained that while NFPA’s standards are typically built on existing NIOSH requirements for respirators, as per 42 CFR 84, NFPA still requires certification above and beyond that offered by NPPTL. One unique aspect of NFPA is its requirement for robust third-party certification conducted through certified accredited organizations and laboratories that assess product quality requirements, conduct initial and annual testing, and conduct some post-market surveillance of certified products. Stull expressed his concern that these NFPA standards may have been written with relatively strict or overreaching requirements. He pointed out that it was nearly 10 years ago—in 2011—that NFPA established a standard for wildland respirators, yet so far no products have been certified that meet that standard. Similarly, in 1999 NFPA established a standard for hooded powered air-purifying respirators (PAPRs), but no product has been qualified against that standard. Stull added that NFPA and NIOSH plan to jointly create a combination self-contained breathing apparatus air-purifying respirator standard, which will be supplemental to what NIOSH already offers.
ASTM International Conformity Assessment
Stull explained that ASTM International is a standards organization that addresses various products and services but is fairly new to the RPD standards space.9 ASTM International has developed several standards that are relevant
8 Stull listed several relevant NFPA standards, including the NFPA 1981 fire service self-contained breathing apparatus standard, the 1984 wildland respirator standard, the NFPA 1986 tactical self-contained breathing apparatus standard, the NFPA 1987 combination respirator standard, and the NFPA 1999 hooded PAPR standard.
to PPE, including standards for emergency escape devices (E2952-17), as well as forthcoming standards for the Test Method for Respirator Fit Capability Conformance Test for Half-Mask Air-Purifying Particulate Respirators, which has nearly been adopted, and the Specification for Barrier Face Coverings, which has been proposed. Additionally, ASTM International has a newly formed F23.65 subcommittee on respiratory protection that has been working on a standard for barrier face coverings, which is intended to aid in the response to the COVID-19 pandemic but has proven challenging to write due to the rapid timeframe for development. ASTM International also has a Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment.10 This guide provides four models of CA based on (1) attestation, (2) testing and inspection levels, (3) quality management systems, and (4) ongoing conformity through the duration of the product’s life in the marketplace. Stull described ASTM International as a nimble organization that is able to include broad representation from stakeholders while still being proactive in moving forward with standards to address immediate needs, such as those associated with the ongoing COVID-19 pandemic.
International Safety Equipment Association Conformity Assessment
Stull said that the International Safety Equipment Association (ISEA) is a trade organization that primarily represents PPE manufacturers in the interests of U.S. consumers.11 It has developed a separate CA standard and a respirator product group that represents the manufacturers of respirators and other interests. ISEA’s conformity standard establishes three levels of conformity with respect to the type of quality management system, the laboratory in which CA testing was conducted, who determines re-testing, the testing interval, corrective or preventive action, record keeping, and declaration of conformity. This process has not always been specified, he added, but it is available for specification by organizations seeking to implement some form of CA.
Comparison of Conformity Assessment Approaches and Recommendations
Stull compared the CA approaches he described above and maintained that the only approach that addresses the full range of the CA processes—-
10 More information about ASTM International’s Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment is available from https://www.astm.org/Standards/F3050.htm (accessed September 16, 2020).
that is, the only ideal approach—is that that of NPPTL (see Table 5-1). The ideal approach addresses the identification of hazards, the identification of PPE types, the selection or development of standards, the definition of CA approach, the performance of CA, and post-market surveillance. Each of the organizations described in the previous section implements various parts of this process, he said, but none of them actually qualifies products. Third-party organizations perform CA for NPPTL and NFPA standards, while NPPTL qualifies third-party organizations to perform CA. He added that there are gaps in the CA approaches used across these organizations.
Given this conclusion, Stull recommended using U.S. standards development organizations to allow for the expansion of product types and for CA that addresses the respiratory protection needs of nontraditional workers. He noted that there are specific CA requirements for NIOSH addressed within 42 CFR 84. However, Stull added, a broader range of products that address the needs of nontraditional users of RPDs should be pursued. He suggested that standards development organizations within the United States have the capacity to reach these user groups and to address their specific needs by involving otherwise unrepresented private or government interests and that they can work with these unrepresented groups to create robust standards. These organizations can build on existing government regulations for additional criteria, including the development of appropriate CA approaches for both standards development and verification of product conformance, and can create other standards for the selection, care, and maintenance of these devices.
Stull also recommended that NIOSH take a centralized role for coordinating the CA process to address the diversity of organizations involved in this space. In this capacity, NIOSH would recognize standards, conduct supportive research for requirements, qualify CA bodies, and provide surveillance support. Stull argued for this recommendation on the basis that the four organizations he discussed in his presentation are uncoordinated, with each addressing specific product needs for various workplaces and products. While the American National Standards Institute has the role of coordinating standards, in practice there is a “free-for-all” in determining which organization performs which roles, Stull said. Thus, he suggested that benefits could be realized if a single agency such as NIOSH could take on the role of centralized coordinator of CA activities for products that are not covered by governmental regulations. Through this coordination, broader CA activity would be more likely to reach nontraditional workers. Stull added that this type of coordinated effort could be used to establish standard practices, guides, and other information that end user groups could use to support their respiratory protection.
|Organization||Identification of Hazards||Identification of PPE Types||Selection or Development of Standards||Define CA Approach||Perform Conformity Assessment|
|NIOSH NPPTL||Pre-market surveillance||U.S. government||U.S. government||U.S. government||U.S. government (third party)|
|CEN||Basic health and safety requirements in EU PPE regulations||By technical committee||By technical committee||By EU PPE regulations||Member recognized notified bodies|
|NFPA||By technical committee||By technical committee||By technical committee||By technical committee||Qualified third-party organization|
|ASTM International*||By workgroup or subcommittee||By workgroup or subcommittee||By workgroup or subcommittee||Not yet implemented||Not yet defined|
|ISEA*||By product group||By product group||By product group||By product group||Qualified as per standard|
* No defined process for post-market surveillance.
NOTE: CA = conformity assessment; CEN = European Committee for Standardization; EU = European Union; ISEA = International Safety Equipment Association; NFPA = National Fire Protection Association; NIOSH = National Institute for Occupational Safety and Health; NPPTL = National Personal Protective Technology Laboratory; PPE = personal protective equipment.
SOURCE: Stull presentation, August 5, 2020.
Occupational Safety and Health Administration and the Nontraditional Workforce
Cohen opened the discussion by highlighting the unique needs of the nontraditional or contingent workforce. Discussant Andrew Levinson, the deputy director of the Directorate of Standards and Guidance at OSHA, said his agency has been dealing with issues related to temporary workers, joint employment, and “gig workers” for the past decade and that this is an area of increasing concern. Levinson said there is an associated issue where workers are misclassified as independent contractors so they are not covered by the Occupational Safety and Health Act of 1970 (OSH Act) in order to avoid complying with OSHA regulations. Levinson said that one of OSHA’s foundational principles is that any employee who is covered by the OSH Act is entitled to the same protection under the OSH Act, OSHA standards, and OSHA whistleblower protections as traditional employees.
In 2013, Levinson said, OSHA started the Temporary Worker Initiative,12 which produced a set of guidance documents developed to better address the complicated nature of nontraditional employer–employee relationships. The OSHA website includes guidance on PPE13 for temporary workers and on respiratory protection programs14 for temporary workers in joint-employment, nontraditional work settings. By 2016 this area had become a significant OSHA concern, he said, and when OSHA revised its guidance for employer programs to address overall safety and health management, a seventh core element was added: communication and coordination for employers, contractors, and staffing agencies.
Levinson said that OSHA approaches the issue of nontraditional employment with a focus on how employers effectively handle communication and coordinate occupational safety and health responsibilities in the work environment of nontraditional employees. As the employer controls the workplace and has the best understanding of the hazards and controls that are necessary to protect its employees, much of the responsibility rests on the employer. OSHA examines how contractors or temporary staffing agencies handle the assignment of OSHA responsi-
14 More information about OSHA’s guidance on respiratory protection from the Temporary Worker Initiative is available from https://www.osha.gov/Publications/OSHA3952.pdf (accessed September 16, 2020).
bilities. He said that there is often some forethought reflected in contracts, agreements, and communication between the host employers and workers on topics such as training, injury, and illness recording and reporting.
Levinson emphasized that OSHA standards in this area are performance-oriented, which allows for a “tremendous amount of flexibility” in how employers implement the requirements, provided that these requirements are accomplished. This flexibility is reflected in respiratory protection standard enforcement memorandums and enforcement interpretations that propose somewhat more complicated, but ultimately effective, methods of ensuring that workers get the necessary components of respiratory protection, Levinson said. For example, labor unions, temporary staffing agencies, contractor associations, trade associations, professional associations, and licensed medical providers may handle different aspects of the respiratory protection program by way of contract or agreement with the employer. These groups may conduct fit testing, medical evaluation, or the training component, while the employers handle only the aspects necessary for on-site work. In this way host employers and temporary staffing agencies can coordinate with service providers to ensure that workers’ protection needs are met. Ultimately, Levinson said, regardless of the avenue that employers use, OSHA is focused on ensuring that workers are afforded all aspects of the respiratory protection standard.
Using the Conformity Assessment Framework to Address Unmet Standards
Cohen asked the panel how having groups of people who are not meeting the standards for respiratory protection programs affects CA. D’Alessandro said the PPE CA framework ultimately guides this process and that when requirements are not being met, the starting point is to look at requirements that the group is able to meet. She suggested that there needs to be a balanced approach in having science-based standards that are also practical. In examining hazards, D’Alessandro said, one determines whether there are existing standards that could address those hazards or whether standards could be modified to address those hazards. Then, the type of PPE that could be used based on those standards can be determined. Therefore, the PPE CA framework can provide a flexible path forward in these cases, as it provides a general process, outlines needs, and offers distinct steps to address these needs.
Stull agreed that the PPE CA framework described earlier is important. He gave an example from a workgroup tasked with determining how to develop standards for “barrier face coverings,” which is the term that the group selected for describing the cloth face coverings that many in the public simply refer to as “masks.” Because both workers and the general public
are wearing these barrier face coverings, a standard for this product could encompass nearly every person in the United States. As such, Stull said, the group wants to avoid creating a standard so lofty that it eliminates every product from the marketplace. However, given the large number of products that have emerged in response to the COVID-19 pandemic, requirements need to be grounded in science, pragmatic, and practical so as to reach all of these diverse user groups, he suggested. Determining fundamental requirements that should apply under the variety of different circumstances in which these barrier face coverings will be used has been a “tremendous challenge,” he added. Ultimately, the group’s work in writing this new consensus standard follows the flow of the PPE CA framework in that it is seeking to (1) define hazards, (2) examine which types of products are being used to address them, (3) write appropriate requirements, and (4) determine how manufacturers demonstrate to buyers that their products are appropriate. Concerning the products, Stull said, user instructions, the limitations of the product, and the types of claims that can be made also need to be considered.
Fit Testing and Requests for the New Devices
Cohen said that the fit-testing requirement is one aspect of the OSHA-defined respiratory protection programs that contingent groups are having difficulty meeting. Cleaning and disinfecting are generally not difficult for filtering facepiece respirators—at least outside of the COVID-19 pandemic—but fit testing appears to be on ongoing challenge. Cohen suggested that developing a respirator standard that requires an effective user seal check instead of fit testing could address this ongoing challenge. However, Cohen pointed out that because OSHA requires fit testing of a tight-fitting respirator, potential complications include coordination with a certifying body (presumably NIOSH) and locating a respirator manufacturer with the vision to create such a product.
Additionally, Cohen said, although there is an NFPA standard for wildland firefighting, no manufacturers make a respirator that meets that standard. Cohen suggested that having an additional group focused on the development of respirators that are specifically designed to meet the unique needs of contingent workforces, such as wildland firefighters, could be of value. Levinson replied that the OSHA fit-test requirement should not be an impediment. He characterized the no-fit-test, tight-fitting respirator as somewhat of a “mythical creature” that may exist but has not yet been found. The current OSHA fit-test requirement for tight-fitting respirators is based on evidence that the fit test is necessary to ensure that (1) the respirator fits properly and (2) the worker receives the expected level of protection. Levinson suggested that if there were widespread confidence
that an alternate standard for a no-fit-test, tight-fitting respirator would ensure an effective fit for the user, OSHA would be open to considering this as a new class of device that could be exempted from the fit-test requirement. However, Levinson said, OSHA has not yet seen evidence that such a product exists, nor are there sufficient data to support eliminating the fit test. However, he added, “OSHA standards are always modifiable if the evidence suggests that they should be.”
Cohen replied that there are accounts of some respirator models that appear to do well with a user seal check in predicting a fit test, although verifying this would require further research to be performed by NIOSH and by manufacturers. Stull added that the working group involved in the development of the draft consensus standard for barrier face coverings is taking a hybrid approach in that it is suggesting the use of a “leakage test” as opposed to a traditional fit test. In this scenario it would be the responsibility of the manufacturer to utilize a small panel that can demonstrate the relative fit of the product. As more manufacturers add the test method, they will learn more about good fit and how to build products with better fit, Stull said. Such an approach might move the process in the right direction, he suggested.
Health Status in the Contingent Workforce
Cohen remarked that air-purifying respirators have inhalation-exhalation resistance requirements so that healthy individuals can be confident they will be able to breathe while using the respirator. However, he added, workers in the contingent workforce do not always have medical testing and medical clearance, so there is a question of whether there is the same level of confidence in the use of these products by these worker groups. D’Alessandro confirmed that NIOSH evaluations are performed according to specific worker criteria that are based on healthy workers.
Clarifying “Nontraditional” Terminology
In the first day’s discussion about nontraditional workers, these worker groups were defined by this committee as workers who perform their duties outside of a formal respiratory protection program. However, the current panel focused on nontraditional employment. Bill Kojola, a retired industrial hygienist, cautioned against conflating the two, explaining that nontraditional employment relates to temporary and contingent workers. Nontraditional workers, by contrast, are typically full-time employees working in an industry without a formal respiratory protection program despite exposure to risk and the associated need for such a program. Cohen added that nontraditional employment could also refer to employees who
are using respiratory protection in the absence of a complete respiratory protection program, regardless of the type of work. This includes workers who are provided respirators by employers who require them to be worn for certain tasks but without a full respirator program, he added.
Expedition of Standards
Cohen relayed a participant’s question about whether there are ways for federal agencies to fast-track the development, approval, and publishing of standards when public health emergencies such as COVID-19 arise and, if so, what the typical timeframe for rolling out such a standard might be. D’Alessandro provided the example of a PAPR standard that was published during the COVID-19 response. Although NIOSH had been working on this standard for years, it likely would have taken an additional year for it to be published. Due to the COVID-19 pandemic, however, NIOSH was able to finalize everything within 1 month and publish it as an interim final rule within several weeks. This indicates that it is possible to expedite such standards, D’Alessandro commented. Peterson remarked that with the success of the PAPR standard rollout and the knowledge gained in the COVID-19 response effort, other activities could be pursued if sufficient resources were in place. Peterson said one of NIOSH’s challenges is ensuring the throughput of equipment into the field while maintaining continuity, making corrections, and pushing out new standards. NIOSH has also been able to effectively convey feedback to consensus standards agencies, Peterson added.
Stull commented that of the alternative CA processes he described in his presentation, ASTM International has an expedited process. If a first draft of an ASTM standard came out perfectly, it would be possible to roll it out within a couple of weeks or months. However, because approving a standard is a consensus process with rules to ensure it is balanced and fair, it is difficult to get a standard through that quickly, he said. On the other hand, the processes can be flexible, and as long as the rules for the consensus process are followed and balance is maintained, these standards can be put out relatively quickly. Stull noted that, generally, this process takes a minimum of 3 months—with 6 months still considered a quick turnaround—but the process often takes much longer. He added that NFPA has a substantially longer process.
Levinson noted that OSHA addresses needs related to a health crisis through enforcement flexibility or interpretation. Also, under the general duty clause, OSHA has the ability to impose some requirements. Furthermore, there is a mechanism for an emergency temporary standard, but Levinson said this is very rarely used and may not have been used in the past two decades.
Occupational Safety and Health Administration Standards and Voluntary Use Provision
Cohen shared a comment from a participant who pointed out that nursing homes and dentists’ offices are places where respirators are being used, but not under the auspices of traditional respiratory protection programs. Levinson explained that if there is a hazard that employees are being protected from, the employer is required to have a respiratory protection program. If an employer is not complying with the standard, that does not mean the employer is not required to comply with the standard. For instance, if OSHA investigated a complaint, it could cite an employer for not using a traditional respiratory program standard. He noted that OSHA has a voluntary use provision under its respiratory protection standard, which is in place for workplaces where an employer has not formally determined that respirators are necessary, but employees are allowed to use these devices for personal comfort reasons (e.g., an employee stirring up incidental dust while cleaning out a storeroom and choosing to wear a respirator for comfort).
Availability of Fit-Test Results
Cohen answered a question from a participant about whether results on respirators tested by a fit-test panel are available for others to use in comparing the results of various models. Cohen said that results are not made available for filtering facepiece respirators, but that this does happen under the standards, certification, and approval for other respirators. Peterson confirmed that there is no requirement within rule 42 CFR for particulate-only type devices.15 Therefore, a fit test is not performed as part of the approval. For other types of respirators there are requirements for collective fit among an identified population rather than individual fit, he said. The NIOSH panel is used to ensure that fit can be achieved across different populations via the variety of sizes or models offered under an approval, he continued. Therefore, Cohen said, the fit requirement is not for individual fit; rather, a fit requirement ensures that a product meets some established criteria for a population. Therefore, fit-test data are not shared because they are considered proprietary information, Cohen added.
Mark Nicas, an emeritus adjunct professor at the University of California, Berkeley, contended that fit results generated by NIOSH testing should not be proprietary information. He suggested that it would benefit program administrators if they could access the results of a fit-panel testing
15 More information about 42 CFR 84 is available from https://www.cdc.gov/niosh/npptl/topics/respirators/pt84abs2.html (accessed September 16, 2020).
for different respirators. This would allow them to assess the fit capability of various products and reduce the time spent fit testing those products for their workforce. He added that fit-testing results would also be helpful information for the public. However, manufacturers are often reluctant to release their results to the general public due to the potential for competitive disadvantage with other manufacturers. Nicas maintained that this government testing should be public information and not held as proprietary by NIOSH. Kojola added that NIOSH has long attempted to establish minimum requirements for the fit of filtering facepiece respirators, but its approval process currently does not include fit requirements. D’Alessandro added that for several years, NIOSH has been participating on an ASTM Committee helping to develop a respiratory fit capability. When this standard is completed it could lead to the assessment of fit capability at some level, and it is considering whether manufacturers would report this as part of their product certification or have it be incorporated by reference in 42 CFR 84.
Final Reflections on the Session
Planning committee member Howard Cohen of the Yale School of Medicine offered his reflections on the presentations and discussions of Session 4A: Assessment Pathways for Respiratory Protective Devices for Nontraditional Workers. Cohen said standards are the foundation of CA processes, and these standards typically presume a certain degree of sophistication in the respiratory protection programs they support. In the case of nontraditional workers, he said, these presumptions are not well-supported because respiratory protection programs do not exist. Thus, he proposed that it is necessary that either (1) these populations are made to adhere to the presumptions of existing standards, or (2) new standards are developed that are appropriate for nontraditional workers. He said that more research is needed to address the challenges of ensuring respiratory protection for nontraditional workers, as respiratory protection is more sophisticated that other forms of PPE, such as earplugs and safety glasses. He concluded that this sophistication—and the persistent gaps in knowledge—may best be addressed through standards and engagement with employers by OSHA and other public health agencies.
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