3M is continuing to address the COVID-19 pandemic with many tactics to help protect those responding to the outbreak, including healthcare workers and first responders. In early April, 3M reached agreement with the U.S. government on a plan that, with the Trump Administration’s assistance, will enable FEMA to import 166.5 million respirators into the United States over a 3-month period starting in April, from our plants in Asia.
The Food and Drug Administration requires this information be made available to everyone who has received these respirators.
Did you receive the product directly from FEMA or from FEMA via a State Authority ? Was your organization required to pay for the product?
No entity other than FEMA is directly acquiring these models from 3M and distributing them in the United States.
The Federal Emergency Management Agency (FEMA) is importing the following models of 3M respirators from Asia: 9010, 9010CN, 9132, 9542, 9542V, 9552, 9502, 9502+, 9502V+, 9541, 9541V, 9501, 9501V+, 9501+ 9505+, 9002, and 9001. These products will be distributed by FEMA, free of charge, to the entities they determine need them the most. If the respirator is one of the model numbers above and has been distributed for free and can be traced to a FEMA source of supply, it is more likely to be an authentic product.
The US Centers for Disease Control and Prevention (CDC) has determined certain approvals from other countries are similar to the N95 because they have similar levels of filtration and assigned protection factors of 10. KN95 is one of the approvals that the CDC has determined is similar to the National Institute for Occupational Safety and Health (NIOSH) N95.
Although KN90 respirators have an assigned protection factor of 10 in China, they are not considered similar to N95 because the filter efficiency is at least 90%, rather than at least 95%.
Here are some answers to questions customers have about respirators imported from Asia.
U.S. Occupational Safety and Health Administration (OSHA) respiratory protection standards mandate that individuals using new respirator models receive training and a fit test prior to the first time they use a respirator. In addition, individuals should read and follow all user instructions, including conducting a user seal check every time they put on a respirator.
3M respirators acquired by FEMA in Asia are fit tested the same way as N95 respirators typically sold and used in the U.S. – with qualitative fit testing using BitrexTM or saccharin, as well as quantitative fit testing using a TSI PortaCount® being acceptable. Respirator fit testing resources can be found on the 3M website.
Several U.S. government agencies have issued temporary authorizations relevant to filtering facepiece respirators (FFRs) approved to other countries’ standards, which authorize 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) has recommended that healthcare institutions that no longer have 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 include 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 addresses 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 addresses 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 has issued an Enforcement Memorandum that indicates that during the COVID-19 pandemic and the resultant shortage of respiratory protection equipment, if employers have 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 have been included in Exhibit 1 to the March 28 EUA and Appendix A to the April 3 EUA. Not all respirator models on these lists are currently being imported into the United States.