The Federal Emergency Management Agency (FEMA), under the Department of Homeland Security, has released a Temporary Final Rule that invokes the Defense Production Act (DPA) to allocate certain Personal Protective Equipment (PPE) for domestic use and prohibit exportation of PPE from the U.S. without express FEMA approval. The mechanics of implementation remain somewhat unclear, but the rule provides for Customs and Border Protection to detain outbound shipments of PPE until FEMA determines whether to return the shipment for domestic use, issue a DPA-covered order against the PPE, or allow the export of all or part of the order in the interest of national defense. Covered PPE (“covered material”) includes:
- N95 Filtering Facepiece Respirators
- Other Filtering Facepiece Respirators
- Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges
- PPE surgical masks
- PPE gloves or surgical gloves
FEMA commits to make determinations “quickly” and “within a reasonable time of being notified of an intended shipment.” The rule exempts covered material 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, provided that at least 80% of the manufacturer’s domestic production of covered material was distributed in the U.S. in the preceding 12 months. Those violating the rule may be subject to a fine up to $10,000, imprisonment for up to one year, and/or an injunction. The rule will be effective when published in the Federal Register, currently scheduled for April 10.