Earlier this month, the Federal Emergency Management Agency (FEMA) published a temporary final rule limiting exports of certain kinds of personal protective equipment (PPE) from the U.S. without explicit approval from the agency. Until August 10, 2020, Customs and Border Protection (CBP) will temporarily detain shipments of certain masks, gloves, and respirators pending review by FEMA. FEMA will determine whether all or part of a shipment should be returned for domestic use, will purchase the items using a rated order, or will allow the shipment to continue onward for export. The rule provided a narrow exemption for U.S. manufacturers who have had export agreements with customers in other countries since at least January 1, 2020, where at least 80% of domestic production was distributed in the U.S. during the preceding 12 months.
Since then, FEMA has continued to tinker with the rollout of the rule by publishing a notice on April 21, which provided more details on the mechanics of the rule and established a number of additional exemptions. To further streamline the process for exporters, CBP has provided additional guidance via its FAQs about exports of PPE.
What Types of PPE are Covered Under the Temporary Final Rule?
Items subject to the rule include the following in-demand PPE items:
- N95 filtering facepiece respirators, including devices that are disposable half-facepiece, nonpowered, air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer;
- Other filtering facepiece respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181;
- Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
- PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; and
- PPE gloves or surgical gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.
What PPE Shipments are Exempt following the April 21 Notice?
- 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).
- Exports of covered materials by nonprofit or nongovernmental 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.***
- 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.
- 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 with final destinations of Canada or Mexico.***
- Shipments by or on behalf of the U.S. federal government, including its military.
Exporters believing that their PPE shipment falls under the original exemption or one of the five exemptions designated with *** must submit a Letter of Attestation (LOA) describing the shipment and applicability of the exemption. LOAs should be submitted to CBP for review through the Automated Export System (AES) via CBP’s document imaging system (DIS) in conjunction with other export documents placed on file with CBP. The LOA should cover the following data elements:
- Description of the type and quantity of the covered materials included in the shipment;
- A description of which exemption(s) the exporter is claiming;
- A statement describing why the exemption applies and the expected end use of the materials in a manner sufficient for CBP and FEMA officials to determine whether the shipment falls under the claimed exemption(s); and
- A statement 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 outlined in the allocation order.
Although a LOA is not required for all other shipments, exporters may elect to submit additional documentation to support FEMA’s decision-making process.
The Review Process
FEMA has clarified that not all shipments of these items will be detained for FEMA’s determination. The review process begins with CBP. CBP will first assess export shipments, including the review of information submitted via AES (e.g., LOA) and physical examination. Once a potential covered shipment is identified, the port will hold the shipment pending review of shipping documents to determine eligibility for an exemption. Those that are clearly within the scope of an exemption will be allowed to proceed.
If a shipment is detained pending review, exporters claiming an exemption at that time (as opposed to early submission via DIS) can submit a LOA via email to email@example.com. In order to associate the LOA with the AES filing, the email should follow this subject line format and include the following data elements within the body of the email:
- The email Subject Line: CAT=GEN; ITN=X12345678910111; ACTION= ADD
TRANSMITTER_NAME= Mandatory (Name of company)
PORT_CD = (4 digit port code) Conditional
POC_INFO= Optional (Name and Phone Number)
COMMENT= Optional (Any clarification/remark)
RETURN_EMAIL_ADDRESS= Optional (if different than sender email address)
For shipments temporarily detained by the port for further review, the information is forwarded to CBP and FEMA headquarters personnel for additional review to make a final determination. FEMA has stated that its goal is to make a decision within 72 hours and communicate it back to the exporter via CBP.
Through its FAQs, CBP has provided further clarification for specific circumstances. For example, in situations where there is no AES data for shipments to Canada, in order to qualify for exemption #9 listed above, exporters can provide CBP with a LOA by either voluntarily filing in AES with a DIS attachment; provide the LOA to CBP when specifically requested; or to preemptively provide the carrier with the LOA to provide to CBP if requested.
Exporters can expedite the review process by filing early in AES and uploading supporting documents as required. Per CBP, shipments should be reported as soon as possible even if the AES filing needs to be later amended prior to export. From an exporter’s point of view, once the LOA and AES filing have been submitted, they should receive confirmation of receipt from CBP. If CBP has temporarily detained a shipment, exporters be notified following CBP’s typical process for notification of holds and releases (including phone calls, email, etc.). Absent any notice of additional action being required, the shipment will be considered cleared for export.