FEMA’s Temporary Final Rule (TFR) allocating certain medical and health resources for domestic use was established to help America’s frontline healthcare workers and the public have access to sufficient Personal Protective Equipment (PPE) during the COVID-19 pandemic, and to ensure that domestic supplies of certain materials are not inappropriately exported abroad.
Although FEMA works to keep the TFR up to date to reflect current shortages of PPE, FEMA recognizes that there may be situations in which the domestic supply of a covered material may exceed the domestic demand.
If you believe you have a surplus of a covered material and can demonstrate a good-faith and unsuccessful attempt to sell the material domestically, you may submit a request to FEMA to allow the material to be exported. (See information on submitting a request below.)
PPE Covered Under the Allocation Order
FEMA is working in close coordination with Customs and Border Protection (CBP) and the members of the Export Cargo Review Working Group, which includes representatives from Customs and Border Protection, the Department of State, the Department of Commerce, and the Food and Drug Administration, to review shipments of the following PPE materials:
- Surgical N-95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;
- PPE surgical masks, including masks that cover the user's nose and mouth and provide a physical barrier to fluids and particulate materials;
- PPE nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and other such nitrile gloves intended for the same purposes;
- Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all the requirements in ANSI/AAMI PB70 and ASTM F2407 – 06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70.
To request an exemption due to a surplus of covered PPE, please submit a Letter of Attestation with the following information to email@example.com. For more information on submitting Letters of Attestation and PPE exports, visit the CSMS #42506108- CBP Frequently Asked Questions About PPE Exports
- The material you wish to export;
- The commercially reasonable efforts you have made to market and sell the material domestically;
- The difference, to the extent known, between the domestic demand and the domestic production; and
- How the proposed export volume will not interfere with continued satisfaction of domestic demand.
DHS will review submitted Letters of Attestation and make every effort to provide parties with a Letter of Decision within three business days.
For information on additional exemptions to the allocation order, go to the Notice of Exemptions published in the Federal Register in April. The Temporary Final Rule allocating certain health and medical resources for domestic use was initially published in April and extended and modified in August to reflect changing circumstances.
The extension published in August allows the TFR to remain in effect, with certain modifications, through Dec. 31, 2020.
FEMA’s Export Cargo Review Working Group will continue to review and evaluate the list of covered materials under the TFR. As needed, the working group will submit requests to the Unified Coordination Group and White House Task Force to make modifications.