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Revocation of NIOSH Public Health Emergency Respirator Approvals

NEWS

Between May and November 2020, NIOSH issued limited, temporary Public Health Emergency (PHE) approvals for N95 filtering facepiece respirators (FFRs) and powered air-purifying respirators (PAPRs) to address respirator supply shortages during that time. In June 2022, NIOSH obsoleted the remaining PHE approvals and advised users to phase-out the use of these respirators in advance of their revocation when the PHE ends.  May 11, 2023, marked the end of the U.S. federal COVID-19 PHE declaration and NIOSH has revoked eight PHE FFR approvals and four PHE PAPR approvals.

For former NIOSH PHE Approval Holders

Since NIOSH has revoked eight PHE FFR approvals and four PHE PAPR approvals, an application for a new NIOSH approval must be submitted and approved by NIOSH through the respirator approval process described in 42 CFR Part 84, NIOSH Conformity Assessment Notice NIOSH CA 2021-1034R1, and the NIOSH Standard Application Procedures.

For more information, view the NIOSH Conformity Assessment Letter to Manufacturers (CA 2023-1058) | NPPTL | NIOSH | CDC

For Users and Purchasers

The PHE-approved respirators are easily recognized by the assigned approval number, which includes the designation “PH.” PHE-approved FFRs are marked TC-84A-PHXX and PHE-approved PAPRs are marked TC-21C-PHXX.  Since NIOSH revoked eight PHE FFR approvals and four PHE PAPR approvals, these respirators are NO LONGER recognized as NIOSH Approved® respirators and therefore cannot be used in workplace settings that require the use of NIOSH Approved respirators.

Users may select and use other NIOSH approved respirators listed on the Certified Equipment List

Source: National Institute for Occupational Safety and Health