FEMA published a Temporary Final Rule (TFR) in the Federal Register on Aug. 10, 2020 allocating certain health and medical resources for domestic use during the COVID-19 pandemic, This TFR is an extension and modification a TFR published on April 10, 2020 which outlined the implementation of the President’s Memorandum, “Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use.” This extension allows the TFR to remain in effect, with certain modifications, through Dec. 31, 2020.
Modifications were made to the types of exports of Personal Protective Equipment that FEMA will review and may hold for domestic use to reflect changing circumstances. For example, shipments of certain classes of surgical gowns are now covered under the TFR and may not leave the United States without explicit approval by FEMA.
FEMA’s Export Cargo Review Working Group, which includes representatives from Customs and Border Protection (CBP), the Department of State, the Department of Commerce, and the Food and Drug Administration, will continue to evaluate the PPE items included in the TFR every two weeks to review updated information about the supply and demand of covered PPE. As needed, the Export Cargo Review Working Group will submit requests to the Unified Coordination Group and White House Task Force to make modifications to the TFR.
Covered PPE Under the Allocation Order
FEMA is working in close coordination with CBP and the members of the Export Cargo Review Working Group 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.
What Happens to PPE Exports Allocated in this Order?
- FEMA may purchase part, or all, of the shipment, using a rated order under Title I of the Defense Production Act.
- FEMA may return all or part of the shipment for distribution in the domestic supply chain.
- FEMA may allow all or part of the shipment to proceed as planned for export.
The Review Process for Allocated PPE Exports
- To clarify, not every shipment of covered materials will be detained for FEMA determination, and not every shipment that is detained for FEMA determination will be prohibited from export.
- After a shipment is sent for export, CBP will conduct a preliminary review of all materials in the Automated Export System (AES), including any Letter of Attestation submitted by the shipper (if necessary). If the export clearly falls within an exemption, CBP may allow the shipment to immediately proceed to export.
- In other circumstances, CBP will send information about the export to FEMA. FEMA will review the shipment with the assistance of the Export Cargo Review Working Group, which includes representatives from CBP, the Department of State, the Department of Commerce, and the Food and Drug Administration. After FEMA makes a determination, FEMA will route the decision back to the exporter through CBP.
- FEMA is taking every action possible to minimize the delays caused by this allocation order. Once notified by CPB, from detainment to determination FEMA aims to make a decision within 72 hours of detainment.
Exemptions of PPE Exports
In order to minimize the disruption of the supply chain and use agency resources efficiently, FEMA has established several exemptions to the allocation order. These exemptions include:
- Shipments to U.S. commonwealths and territories, including Guam, American Samoa, Puerto Rico, U.S. Virgin Islands, and the Commonwealth of the Northern Mariana Islands (Including minor outlying islands).
- 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. These may be shipped via intermediaries (logistics providers) but are shipped from and consigned to foreign governments
- 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.
The following exemptions require a Letter of Attestation describing the shipment and why it should be excluded from the allocation order:
- Shipments made by or on behalf of U.S. manufacturers with continuous export agreements with customers in other countries since at least January 1, 2020, so long as at least 80 percent of such manufacturer’s domestic production of covered materials, on a per item basis, was distributed in the United States 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.
- 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: shipments in transit through the United States 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.
When and How to Submit a Letter of Attestation
Letters of Attestation are only needed if the shipper plans to export one or more of the covered materials listed in the allocation order, and if this shipment falls under one of the exemptions for which a letter of attestation is required.
FEMA recommends including the following information in a Letter of Attestation:
- Must be on company letterhead.
- Description of the type and quantity of covered materials that are included in the shipment. If the shipment does not contain any of the covered materials, then there is no need to file the attestation letter, as the shipment falls outside the allocation order.
- A description of which exemption(s) the owner or exporter believes the shipment falls into.
- A brief statement describing why the claimed exemption applies.
- A brief statement describing the expected end use of the exported materials.
- A statement confirming that the provided information is true and accurate to the best of the exporter’s knowledge, and that the exporter is aware that false information is subject to prosecution under the Defense Production Act, as described in the allocation order.
Letters of Attestation must be submitted in conjunction with export paperwork through the Automated Export System (AES) to Customs and Border Protection. The AES allows for the attachment of documents, such as Letters of Attestation, under the tab “Document Imaging System.”
Exporters with a Surplus of Covered Material
If a shipper believes they have a surplus of a covered material and can demonstrate a good-faith and unsuccessful attempt to sell the material domestically, they may be exempt. For more information on this exemption, review our fact sheet.
For more information on exemptions, review the Notification of Exemptions which was published in the Federal Register in April to supplement the TFR.
Exporters who take Advantage of Exemptions
If CBP believes that an exporter is intentionally modifying its shipments to take advantage of one or more exemptions, CBP may detain a shipment and forward information about that shipment (including the basis for CBP’s belief of the intentional modification) to FEMA for determination.
In addition, CBP may, in its discretion, forward on additional shipments to FEMA for consideration if the agency does not believe a shipment falls clearly into one or more exemptions.
Relevant Authorities for Allocation Actions
Defense Production Act – Title I
The section of the DPA allows the President, and appropriately delegated agencies, to “allocate materials, services, and facilities in such manner, upon such conditions, and to such extent as he shall deem necessary or appropriate to promote the national defense” (50 U.S. Code § 4511(a)(2)).
The President Signed Executive Order 13911 on March 27, 2020. Title 4 of this Executive Order gave the Secretary of Homeland Security and the Secretary of Health and Human Services the authority to implement Title 1 of the DPA. In turn, on April 1, 2020 the Secretary of Homeland Security delegated this authority to the FEMA Administrator in Department of Homeland Security Delegation 09052 Rev 00.1, “Delegation of Defense Production Act Authority to the Administrator of the Federal Emergency Management Agency.”
In the Memorandum signed on April 3, 2020 the President noted that “it is the policy of the United States to prevent domestic brokers, distributors, and other intermediaries” from diverting five types of covered material overseas. The Memorandum directed the Secretary of Homeland Security, through the Administrator of FEMA, to “use any and all authority available under section 101 of the [DPA] to allocate to domestic use, as appropriate” the five types of covered materials provided text box.
On April 10, 2020 the FEMA Administrator issued and published the allocation order in the Federal Register. The allocation order allows FEMA to review shipments of PPE subject to this allotment order which include: N95 respirators, and a variety of other filtering respirators; air-purifying respirators; surgical masks; and, surgical gloves. These are the same five types of materials referenced in the President’s Memorandum.
For Additional Questions
For questions for Customs and Border Protection, visit their website.
For general questions about the allocation order and Notice of Exemptions in the Federal Register, send an email to FEMA National Business Emergency Operations Center at NBEOC@max.gov.