FEMA's new temporary final rule

FEMA's Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use TFR

The Federal Emergency Management Agency (FEMA) published their temporary final rule in the April 10 edition of the Federal Register, notifying the Trade that they will allocate certain scarce or threatened materials for domestic use, so that these materials may not be exported from the United States without explicit approval by FEMA. The ruling covers the following five types of Personal protective equipment (PPE):

• 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 material; 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.

For more details, please review the Federal Register notice at https://www.govinfo.gov/content/pkg/FR-2020-04-10/pdf/2020-07659.pdf