United States of America published rule on approval tests and standards for air-purifying particulate respirators

Centers for Disease Control and Prevention (CDC) and  Health and Human Services (HHS) is publishing 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 in the ongoing public health emergency. With this rulemaking, parallel performance standards are 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 currently experiencing 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 consolidates 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 are 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, currently in demand by healthcare workers and emergency responders. NIOSH expects that the addition of PAPR100 devices to the marketplace will help to relieve the current high demand for possibly hundreds of thousands of additional particulate filtering facepiece respirators needed specifically for healthcare and emergency medical response settings.

Products covered : Air-purifying particulate respirators; Other breathing appliances and gas masks, excluding protective masks having neither mechanical parts nor replaceable filters , Quality (ICS 03.120), Medical equipment (ICS 11.040), Respiratory protective devices (ICS 13.340.30), Test conditions and procedures in general (ICS 19.020)’

HS Code: 9020

Proposed date of adoption: 14 April 2020

Proposed date of entry into force: 14 April 2020

Final date for comments: 12 August 2020

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