April 13, 2020 – U.S. Customs and Border Protection (CBP) provided updated guidance relating to a Presidential Memorandum, where scarce material used in combatting COVID-19 being exported from the U.S, may be re-allocated for domestic use, to prevent diversion of these material overseas.
Under a Temporary Final Rule, exports of the below personal protective equipment (PPE), will be re-delegated to the Federal Emergency Management Agency (FEMA), with certain exceptions.
- 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/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.
FEMA is focusing on commercial quantities, defined as shipments valued $2500 or over and containing more than 10,000 units of PPE goods. Only exports of commercial quantities are being detained at this time.
CBP provided exclusions for :
- In-transit shipments
- Exports to Canada or Mexico; or to U.S. Government entities (such as military bases overseas)
- Exports by U.S. Government agencies; U.S. charities; critical infrastructure industries for the protection of their workers; 3M Company; and Express or Mail Parcels not meeting commercial quantities.
Ports will continue to assess risk on shipments filed in the Automated Export System (AES) and target shipments of commercial quantities that do not meet exclusions listed.
If you have any questions regarding FEMA re-delegating exports of PPEs used to combat COVID-19 for domestic use, Livingston can help! Please contact either your Livingston account manager or our regulatory affairs group at firstname.lastname@example.org