Approval Tests and Standards for Air-Purifying Particulate Respirators

April 2020

NIOSH Docket Number 335, CDC-2020-0036

The Department of Health and Human Service (HHS) published this interim final rule to update the regulatory requirements used by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) to test and approve air-purifying particulate respirators for use during and after the public health emergency. With this rulemaking, parallel performance standards were added to existing regulatory requirements for PAPRs to allow for the approval of respirators in a new class, PAPR100, that may be better suited to the needs of workers in the healthcare and public safety sectors that may have experienced a shortage of air-purifying particulate respirators due to Coronavirus Disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This rulemaking also consolidated the technical standards for all types of air-purifying particulate respirators into one subpart, and standards pertaining to obsolete respirators designed for dust, fume, and mist; pesticide; and paint spray were removed from the regulation entirely. This rulemaking will have no substantive impact on the continued certification testing and approval by the NIOSH National Personal Protective Technology Laboratory of existing PAPR class HE (high-efficiency series) respirators or non-powered air-purifying particulate respirators, including N95 filtering facepiece respirators, still in demand by healthcare workers and emergency responders. NIOSH expected that the addition of PAPR100 devices to the marketplace would help to relieve the current higher demand for possibly hundreds of thousands of additional particulate filtering facepiece respirators needed specifically for healthcare and emergency medical response settings.

To view the notice and related materials, visit https://www.regulations.govexternal icon  and enter CDC-2020-0036 in the search field and click “Search.”

Reference Documents

Federal Register Notice: Federal Register Notice pdf icon[PDF – 358 KB]

Federal Register Notice: Federal Register Notice pdf icon[PDF – 266 KB]Reopened for comments

Page last reviewed: September 28, 2020