As part of its response to the COVID-19 pandemic, the U.S. government has taken measures to ensure domestic supply of personal protective equipment (PPE) by both facilitating imports and restricting exports.

Import Measures

Frontline regulation of imports falls to Customs and Border Protection (CBP). However, in this role, CBP enforces a myriad of rules promulgated by other federal agencies, including various product standards. In the case of medical devices such as certain types of PPE, the Food and Drug Administration (FDA) plays a leading role in establishing such standards. In order to facilitate and expedite the importation of products that address immediate, urgent public health needs, the FDA has issued guidance entitled Information for Filing Personal Protective Equipment and Medical Devices During COVID-19.

The guidance addresses three categories of PPE, as follows:

• General purpose or industrial PPE not intended for prevention of disease or illness (including certain masks, respirators, gloves, etc.) that is not regulated by the FDA.
• Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA) issued by the FDA (certain respirators, test kits, face masks and shields, ventilators, etc.).
• Products regulated by the FDA as a device but not authorized by an EUA, but for which an enforcement discretion policy has been published (certain clinical electronic thermometers, gowns and gloves, sterilizers, disinfectant devices and air purifiers, face masks and respirators, ventilators, diagnostic tests, etc.).

For each category of products, the guidance specifies whether the FDA is to be provided with entry information and, if so, what supporting documentation is required. The guidance is updated regularly, so importers are urged to check the CBP and FDA websites for updates before proceeding.

Export Restrictions

On April 3, pursuant to authority granted by the Defense Production Act (DPA), the President ordered the Secretary of Homeland Security and the Administrator of the Federal Emergency Management Agency (FEMA) to allocate certain scarce PPE for domestic use, as appropriate.

Pursuant to this mandate, FEMA issued a temporary rule restricting such exports until August 10, 2020. The rule applies to “covered materials” – i.e., (i) N95 filtering facepiece respirators; (ii) other filtering facepiece respirators, including those designated as N99, N100, R95, R99, R100, P95, P99 or P100; (iii) elastomeric air-purifying respirators and particulate filters and cartridges; (iv) PPE surgical masks; and (v) PPE gloves or surgical gloves.

The rule directs CBP to notify FEMA of intended exports of covered materials and detain any such shipments pending FEMA’s determination whether to (i) return the shipment for domestic use or (ii) issue a rated order for all or part of the shipment under FEMA’s DPA authority. FEMA is required to make its determination “within a reasonable timeframe” after receiving notice from CBP.

FEMA is authorized to establish exemptions from these requirements that are “necessary or appropriate to promote the national defense.” The current exemptions, as provided in the temporary rule and a subsequent notice published on April 17, cover the following exports:

• Shipments by U.S. manufacturers with continuous export agreements with customers in other countries since January 1, if 80% or more of such manufacturer’s production of the covered material shipped was distributed domestically in the preceding 12 months.
• Shipments to U.S. commonwealths and territories (such as Guam, Puerto Rico, etc.).
• Certain humanitarian donations.
• Intracompany transfers by U.S. companies to their foreign affiliates.
• Shipments for assembly in medical and diagnostic testing kits intended for sale and delivery to the United States.
• Sealed sterile medical and diagnostic testing kits containing covered materials that cannot be removed without damaging the kits.
• Diplomatic shipments from foreign embassies and consulates to their home countries.
• Shipments to overseas U.S. military addresses, diplomatic posts and embassies.
• In-transit shipments, including shipments temporarily entered into a warehouse or temporarily admitted to a foreign trade zone.
• Shipments for final destinations in Canada or Mexico.
• Shipments by or on behalf of the U.S. federal government and military.

Notably, however, the exemptions may be waived at any time if FEMA determines that doing so is necessary or appropriate to promote the national defense.

In many cases, use of the exemption must be supported by a letter of attestation submitted to FEMA via CBP’s document imaging system certifying the purpose of the shipment and compliance with the conditions of the exemption. The letter must be submitted to CBP with other documentation related to the shipment and must contain the information outlined in the notice.