3M Respirators in International Packaging Made Available in US during COVID-19

Several U.S. government agencies had issued temporary authorizations relevant to filtering facepiece respirators (FFRs) approved to other countries’ standards, which authorized those respirators to be used in U.S. healthcare settings even though such use would normally not be permitted.

In its Strategies for Optimizing the Supply of N95 Respirators, the U.S. Centers for Disease Control and Prevention (CDC) had recommended that healthcare institutions that no longer had access to any N95 respirators consider alternative respirators that are approved by other countries for occupational use and are similar to N95 respirators. Similar respirators included those approved to the following standards: Australia / New Zealand P2, China KN95, Japan DS2, and Korea Special 1stClass.

On March 28, 2020, the U.S. Food and Drug Administration (FDA) issued an EUA that addressed the use of respirators approved to other countries’ and region’s standards during the public health emergency due to COVID-19, including those of Australia, Brazil, Europe, Japan, Korea and Mexico. On April 3, 2020, the FDA issued a second EUA that addressed respirators approved to the China standards.

The U.S. Occupational Safety and Health Administration (OSHA), the agency that regulates the selection and use of respirators in the workplace (PDF, 1.15 MB), states that only NIOSH-approved respirators may be used by U.S. workers (PDF, 1.15 MB). However, OSHA had issued an Enforcement Memorandum that indicated that during the COVID-19 pandemic and the resultant shortage of respiratory protection equipment, if employers exhausted all other options to reduce exposures and explored alternative respiratory protection options, then it is preferred that respirators approved to other countries’ standards be used, rather than masks or other items that are not designed to provide exposure reduction.

The China KN90 approval is not considered similar to the U.S. NIOSH N95 approval by the US CDC and US OSHA.

Several 3M filtering facepiece respirator (FFR) models were in Exhibit 1 to the March 28 EUA and Appendix A to the April 3 EUA. Not all respirator models on these lists were imported into the United States.

On June 30, 2021, the FDA announced the revocation of the EUAs for non-NIOSH approved respirators from China and other countries outside the US due to multiple factors including the increase in availability of NIOSH approved respirators. This revocation was effective July 6, 2021 and affects the emergency use authorization of such respirators by healthcare personnel in healthcare settings. Visit www.fda.gov for additional information. In addition, on July 7, 2021, OSHA rescinded their temporary enforcement discretion memorandum, stating that “....circumstances precipitating the issuance of OSHA’s respiratory protection enforcement discretion memoranda no longer exist. Therefore, where respirator supplies and services are readily available, OSHA will cease to exercise enforcement discretion for temporary noncompliance with the Respiratory Protection standard based on employers’ claims of supply shortages due to the COVID-19 pandemic.” Agency guidance is subject to change. Facilities should consult the latest guidance.