Final Rules on Tests, Standards for NIOSH-Approved Respirators Scheduled for This Year
The U.S. Department of Health and Human Services (HHS) intends to issue final rules this year on approval tests and standards for air-purifying particulate respirators and combination unit respirators, according to the latest agenda of federal regulatory and deregulatory actions, which was published on July 3. The agenda lists both rules, which concern requirements used by NIOSH to test and approve certain respirators, in the final stage of rulemaking.
According to the agenda, HHS plans to issue a final rule this month to finalize performance standards allowing for NIOSH approval of the “PAPR100” class of powered-air purifying particulate respirators. The new class of PAPRs was created by an interim final rule published in 2020. At that time, NIOSH thought that the new PAPRs might be better suited to the needs of workers in the healthcare and public safety industries who required protection from COVID-19. The recently updated regulatory agenda explains that the requirements set in the interim final rule have “the potential to extend the same proven level of protection [from the current PAPR approval program] to smaller, lighter systems which may be more comfortable to wear.”
In November, HHS intends to issue a final rule that would allow NIOSH to approve combination unit respirators, or CURs, a new class of respiratory protective device. The notice of proposed rulemaking on this topic, issued in 2024, explains that CURs “[employ] the technology of at least two different types of respiratory protective devices, with one being an open-circuit self-contained breathing apparatus (SCBA) and at least one other method being air-purifying or powered air-purifying.” These devices are currently used in military, law enforcement, and some industrial settings.
The current respirator approval program regulations in 42 CFR Part 84 do not allow NIOSH to approve CURs since they are single units within more than one respirator class. This rulemaking would add a new subpart to establish performance standards for NIOSH to approve CURs by incorporating by reference the consensus standard NFPA 1987, Standard on Combination Unit Respirator Systems for Tactical and Technical Operations. NFPA 1987, published in 2023, “specifies the minimum requirements for the certification, labeling, design, performance, and testing of new CURs, replacement parts, components, and accessories,” according to the National Fire Protection Association.
Further details about the rules on approval tests and standards can be found on the regulatory agenda pages for air-purifying particulate respirators and CURs.
For more information on these and other rules, view the full agency rule list for HHS.