U.S. Government Restricts Exports of Respirators, Masks and Gloves During Pandemic
On April 7, 2020, the Federal Emergency Management Agency (“FEMA”) issued a temporary final rule to restrict exports of respirators, masks and gloves used by healthcare providers. The restrictions, which will remain in effect until at least August 10, 2020, reserve these materials for domestic use during the COVID-19 pandemic. The temporary final rule can be viewed here.
In guidance issued to operations directors on April 9, 2020, U.S. Customs and Border Protection (“CBP”) notes that FEMA is focused on restricting exports of “commercial quantities” – shipments valued over $2,500 or including more than 10,000 units of the covered materials described below.
The temporary final rule prohibits the export of five types of personal protective equipment (“PPE”) without explicit approval by FEMA:
- N95 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;
- 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 C.F.R. § 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 C.F.R. § 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such gloves intended for the same purposes.
These items are designated as “covered materials” under the rule, and this list is consistent with the list of “scarce or threatened materials” identified in the “Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use” issued by the White House on April 3, 2020. The Memorandum directs the Secretary of Homeland Security and the Administrator of FEMA to “use any and all authority available under section 101 of the [Defense Production] Act to allocate” the covered materials to domestic use.
CBP will temporarily detain all shipments of covered materials to allow FEMA to determine whether to prohibit the exports. FEMA also may issue rated orders for the items under the Defense Production Act, in which case FEMA would purchase the products itself, and the rated orders would take priority over commercial contracts.
In making its determination, FEMA will consider the “totality of the circumstances,” including considerations such as allocation of the items for domestic use, disruption to the supply chain, humanitarian and diplomatic considerations.
CBP’s April 9 guidance identifies significant exclusions from the export restrictions, including exports to Canada or Mexico, exports to U.S. military bases overseas, exports by U.S. government agencies, exports by U.S. charities, and exports by the 3M Company. There is also an exclusion from the restrictions to allow businesses in critical infrastructure industries, such as the energy sector, to export the covered materials for the protection of their workers.
In addition, the rule exempts shipments made by U.S. manufacturers with purchase agreements in place with customers abroad since before January 1, 2020, so long as at least 80 percent of the manufacturer’s domestic production of covered materials was distributed in the United States in the preceding 12 months. If FEMA determines that a shipment of covered materials falls within this exemption, the shipment may proceed. FEMA will inform CBP when the exemption applies to a detained shipment.
FEMA will seek an injunction or other order for violations or potential violations of the temporary final rule. In addition, failure to comply fully with the rule is a crime punishable by a fine of not more than $10,000 or imprisonment for not more than one year, or both. A violator who fraudulently or knowingly exports or attempts to export any restricted item, receives such items, or facilitates the transportation, concealment, or sale of such items faces imprisonment for up to 10 years, a fine, or both, if convicted.
Please visit our Coronavirus: Preparation & Response series for additional resources we hope will be helpful.
This information is provided by Vinson & Elkins LLP for educational and informational purposes only and is not intended, nor should it be construed, as legal advice.