On December 31, 2020, the Federal Emergency Management Agency (“FEMA”) published a temporary final rule again extending and modifying export restrictions on scarce and critical health and medical supplies. The new rule clarifies existing restricted categories and adds certain syringes and hypodermic needles to the list of supplies that cannot be exported from the United States without explicit FEMA approval. The new rule extends the restrictions until June 30, 2021.
Under the original rule issued in April 2020, FEMA restricted exports of certain “covered materials,” including Personal Protective Equipment (“PPE”), to reserve these supplies for domestic use in fighting the COVID-19 pandemic. Please see our alert on FEMA’s original export restrictions here, our alert on exemptions here, and our alert on a previous modification here.
In addition to extending the time period for the restrictions, FEMA also modified the list of scarce and critical materials to reflect current domestic needs. The export restrictions now apply to the following items:
- Syringes and Needles – FEMA is adding certain piston syringes and hypodermic needles to the list of covered materials so that these materials can be reserved for COVID-19 vaccinations. A dramatic increase in influenza vaccinations is also tightening supply of these syringes and needles.
- Respirators – FEMA will continue to limit exports of surgical N95 filtering facepiece respirators. These respirators remain subject to high demand within the United States, and given the forecasts of increased COVID-19 cases and hospitalizations, supply is not expected to catch up with demand.
- Masks – FEMA will continue to limit exports of PPE surgical masks, and the new rule provides specific standards designating the restricted masks.
- Gloves – FEMA will continue to limit exports of certain PPE nitrile gloves used in surgery and medical exams, with a modification to clarify the types of gloves subject to the restrictions.
- Gowns – FEMA will continue to limit exports of certain surgical gowns and surgical isolation gowns. These special surgical gowns meet certain technical standards including liquid barrier performance.
FEMA will continue to work with manufacturers, brokers, distributors, exporters, and shippers to ensure compliance with the restrictions. U.S. Customs and Border Protection will continue to detain shipments of the covered materials temporarily, to allow FEMA to determine whether to return the items for domestic use, to issue a rated Government order for the items under the Defense Production Act, or to allow the export of part or all of the shipments. FEMA has pledged to work to make those determinations quickly in order to minimize disruptions to the supply chain domestically and abroad.
