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HHS/CDC RIN: 0920-AA77 Publication ID: Fall 2023 
Title: Respirator Fit Capability Test Standard, Filter Shelf Life, and Application Requirements for Air-Purifying Particulate Respirators 

HHS is publishing this proposed rule to propose a new performance standard designed to allow the National Institute for Occupational Safety and Health (NIOSH) to test the fit characteristics of non-powered, air-purifying, particulate-only half-facepiece respirators during the approval process. The new respirator fit capability standard, developed by ASTM International in collaboration with the NIOSH National Personal Protective Technology Laboratory, would be incorporated by reference into the existing respirator regulations for both filtering facepiece respirators and elastomeric respirators equipped with any type of particulate filter. The intent of the new standard is to ensure that an approved non-powered, air-purifying respirator is capable of fitting its intended population. The proposed rule would also require that approval holders identify the shelf life (i.e., the product’s use-by date) of particulate filters, including Filtering Facepiece Respirators (FFRs), on product packaging and in user instructions. Finally, the rule would require manufacturers to provide NIOSH with a description of FFR product packaging in order to aid NIOSH in better identifying counterfeit respirators being sold on the market. HHS expects that this action will result in improved respiratory protection for healthcare workers, emergency responders, and other workers who may be exposed to particulate and aerosol hazards.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 84.182   
Legal Authority: Pub. L. 91-596    Pub. L. 179    Pub. L. 91-173   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Rachel Weiss
Public Health Analyst
Department of Health and Human Services
Centers for Disease Control and Prevention
1090 Tusculum Avenue, MS C-46,
Cincinnati, OH 45226
Phone:404 498-2500