On May 19, 2021, the Federal Emergency Management Agency (“FEMA”) announced that it is removing export restrictions on four categories of personal protective equipment (“PPE”) and other items used to address the effects of the COVID-19 pandemic. In addition, FEMA now offers exporters an exemption from the remaining restrictions if they have a surplus of the materials to be exported.

Over a year ago, in April 2020, FEMA first restricted exports of PPE and other supplies in order to reserve them for domestic use in fighting the COVID-19 pandemic. Please see our elert on FEMA’s original export restrictions here, our elert on exemptions here, and our elerts on previous modifications to the rule here and here. The temporary final rule, with the most recent changes, remains in effect until June 30, 2021.

Export Restrictions Removed

FEMA’s export restrictions no longer apply to:

  • Industrial N95 respirators, including devices that are approved by the National Institute for Occupational Safety and Health for use in healthcare settings under an Emergency Use Authorization issued by the Food and Drug Administration.
  • PPE surgical masks, including those that cover the user’s nose and mouth providing a physical barrier meeting certain fluid barrier protection standards.
  • Piston syringes that allow for the controlled and precise flow of liquid as described in certain regulations and standards.
  • Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act.

Exports of these items no longer require explicit approvals from FEMA. Export restrictions remain in place for surgical, single-use, disposable N95 respirators; certain PPE nitrile exam and surgical gloves; level 3 and level 4 surgical gowns; and surgical isolation gowns.

Exemptions for Surplus Items

In addition, for the items remaining subject to the restrictions, FEMA now allows exporters to request exemptions to export surplus goods. To qualify for an exemption, an exporter must “demonstrate a good-faith and unsuccessful attempt to sell the material to the domestic market.” An exporter seeking this exemption should submit a letter of attestation to FEMA describing (1) the surplus material to be exported; (2) the commercially reasonable efforts that have been made to market and sell the material domestically; (3) the difference between the domestic demand and domestic production; and (4) how the proposed volume of exports will not interfere with continued satisfaction of domestic demand. FEMA will make an effort to respond with a decision within three business days but does not guarantee this timeline.