On April 10, 2020, in Federal Register Notice (FRN) 85 FR 20195, the Federal Emergency Management Agency (FEMA) announced the restriction of exports of certain personal protective equipment (PPE) from the U.S. without explicit approval. This rule allows FEMA to allocate certain scarce or threatened material for domestic use and is effective from April 7, 2020 until August 10, 2020.
The affected products are:
- “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.”
According to the FRN, before PPE shipments are exported, US Customs and Border Protection (CBP) will detain the shipment to allow for FEMA to review. FEMA will determine whether to “return for domestic use, issue a rated order for, or allow the export of part or all of the shipment.” FEMA’s determination will be made in a reasonable time from shipment notification and will take into consideration various factors outlined in the FRN.
The FRN can be found here:
