Update: On April 27, 2020, CBP issued a set of frequently asked questions for exporters about the temporary rule issued by FEMA on April 10, 2020 requiring FEMA’s approval for exports from the United States of five types of PPE. Click here to read the CBP frequently asked questions.
The Federal Emergency Management Agency (“FEMA”) announced in an April 10, 2020 Federal Register notice that exporters will require approval from FEMA to export from the United States five types of personal protective equipment (“PPE”), subject to an exemption for certain continuous exports. The rule is effective from April 7, 2020 through August 10, 2020.
Under the rule, Customs and Border Protection (“CBP”) will temporarily detain any shipment of covered gloves, masks, or respirators, as defined below, to allow FEMA to determine which PPE to return for domestic use and purchase by FEMA or to allow, in whole or in part, to be exported from the United States. FEMA will make these determinations “within a reasonable time of being notified of an intended shipment.”
Exports by US manufacturers who have had continuous export agreements with customers outside the United States since at least January 1, 2020 are exempted from the rule, provided at least 80 percent of their US-based production was distributed in the United States over the preceding 12 month period. FEMA may revoke this exemption if “necessary or appropriate to promote the national defense.” Unlike a general license or license exemption under other US export control regimes, FEMA will be responsible for applying this exemption at its own discretion after detention of a shipment by CBP.
Finally, exporters are reminded that other US sanctions and export control regimes, such as the Export Administration Regulations (“EAR”), may apply to their shipments. The FEMA rule appears to apply only to exports from the United States and not to PPE held or produced by US persons outside the United States.
The following are “covered materials” for the purposes of the FEMA rule:
- 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 CFR 84.181;
- Elastomeric, air-purifying respirators and appropriate particulate filters and cartridges;
- PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials;
- 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.
For more information on how the FEMA rules or other US export control rules apply to your company’s shipments, contact a member of Steptoe’s export controls team.