On July 1, 2021, the Federal Emergency Management Agency (FEMA) announced the expiration of its Temporary Final Rule (TFR) allocating certain health and medical resources for domestic use. The TFR – originally issued on April 10, 2020 and reissued for a second time on December 31, 2020 – prohibited surgical N95 filter facepiece respirators, personal protective equipment (PPE) surgical masks, PPE nitrile gloves, level 3 and 4 surgical gowns and surgical isolation gowns, piston syringes, and hypodermic needles from being exported from the United States without the explicit approval of FEMA.
Under the TFR, Customs and Border Protection (CBP) officials were required to notify FEMA of any intended export of the covered materials and to detain shipments until FEMA determined to either return the product for domestic use, issue a rated order, or allow the exportation of part or all of the product. Notably, FEMA also published the following 11 exemptions to its TFR:
- Sealed, sterile medical kits and diagnostic testing kits where only a portion of the kit is made up of one or more covered materials that cannot be easily removed without damaging the kits.
- Declared diplomatic shipments from foreign embassies and consulates to their home countries.
- Shipments to overseas U.S. military addresses, foreign service posts (e.g., diplomatic post offices), and embassies.
- Shipments by or on behalf of the U.S. federal government, including its military.
- Shipments to U.S. commonwealths and territories
- Shipments made by or on behalf of U.S. manufacturers with continuous customer export agreements in other countries since at least January 1, 2020 as long as at least 80 percent of such manufacturer’s domestic production of covered materials, on a per item basis, was distributed in the U.S. in the preceding 12 months.
- Exports of covered materials by non-profit or non-governmental organizations that are solely for donation to foreign charities or governments for free distribution (not sale) at their destination(s).
- Intracompany transfers of covered materials by U.S. companies from domestic facilities to company-owned or affiliated foreign facilities for internal use. The letter of attestation for this exemption must state the intended use of the covered materials. This exemption does not cover intracompany transfers for the purpose of resale.
- Shipments of covered materials that are exported solely for assembly in medical kits and diagnostic testing kits destined for U.S. sale and delivery.
- In-transit merchandise, or shipments in transit through the U.S. with a foreign shipper and consignee, including shipments temporarily entered into a warehouse or temporarily admitted to a foreign trade zone.
- Shipments for which the final destination is Canada or Mexico.
The press release announcing the expiration of the TFR is available here.
For more information on actions related to Covid-19 guidance, contact our team and see previous posts below.