Current Issues in the Assessment of Respiratory Protective Devices for Occupational and Non-Occupational Uses Proceedings of a Workshop (2021) / Chapter Skim
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5 Assessment Pathways for Respiratory Protective Devices for Occupational Use by Nontraditional Workers
5 Assessment Pathways for Respiratory Protective Devices for Occupational Use by Nontraditional Workers
Pages 53-74
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From page 53... ...
RESPIRATORY PROTECTION AND CONFORMITY ASSESSMENT IN OCCUPATIONAL SETTINGS Maryann D'Alessandro, the director of the National Personal Protective Technology Laboratory (NPPTL) at the National Institute for Occupational Safety and Health (NIOSH)
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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)
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From page 55... ...
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.
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FIGURE 5-2 Personal protective equipment conformity assessment framework. NOTE: CA = conformity assessment; PPE = personal protective equipment.
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RESPIRATOR APPROVAL FOR USE IN WORKPLACES 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.
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From page 58... ...
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.
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FIGURE 5-4 Example of the NIOSH respirator approval process workflow. NOTE: RPD = respiratory protective device.
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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 postapproval product audits until 2015, when NIOSH's regulation changed and allowed it to expand the product audit program.
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ALTERNATIVE CONFORMITY ASSESSMENT APPROACHES 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.
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From page 62... ...
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.
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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 7 More information about NFPA is available from https://www.nfpa.org (accessed September 16, 2020)
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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 Assess ment of Personal Protective Clothing and Equipment is available from https://www.astm.org/ Standards/F3050.htm (accessed September 16, 2020)
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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.
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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.
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From page 67... ...
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.
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From page 68... ...
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.
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From page 69... ...
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)
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From page 70... ...
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.
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From page 71... ...
Peterson said one of NIOSH's challenges is ensur ing the throughput of equipment into the field while maintaining con inuity, t making corrections, and pushing out new standards. NIOSH has also been able to effectively convey feedback to consensus standards agencies, Peterson added.
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From page 72... ...
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.
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From page 73... ...
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.
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