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. NIOSH posted two notices—one for users and one for NIOSH approval holders—announcing the immediate action to obsolete (phase out) these PHE approvals. Obsoleted respirators are no longer permitted to be manufactured by the approval holder but can continue to be sold, used, and recognized as NIOSH approved until the approval is revoked or rescinded.
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, and both are easily identified on the NIOSH Certified Equipment List. Effective immediately, the 14 active FFR PHE and 5 active PAPR PHE approvals are obsolete.
Users in workplace settings that require the use of NIOSH-approved respirators may continue to use the obsoleted PHE-approved FFRs and PAPRs until the COVID-19 public health emergency ends. Once the public health emergency ends, the obsoleted approvals will be revoked by NIOSH, meaning they are no longer recognized as NIOSH-approved and cannot be used in workplace settings where the use of NIOSH-approved respirators is required.
For more information, view the NIOSH Respiratory Protective Device Information (CA 2022-1044).
For NIOSH Approval Holders
In July 2021, NIOSH reminded PHE approval holders that these approvals are limited and temporary and will be revoked when the COVID-19 public health emergency declaration ends. Approval holders may rescind a PHE approval by emailing the NIOSH Approval Program to identify the approval number to be rescinded.
Approval holders may submit a new approval application to obtain a conventional NIOSH approval. 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 2022-1045)