On April 10th, the Federal Emergency Management Agency (FEMA) issued a Temporary Final Rule (TFR) entitled Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Consumption. The TFR allocates to domestic use, as appropriate, several types of scarce or threatened materials (“covered materials”):
- 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.
In the more than two months since the TFR was published, the domestic supply of certain covered materials may now exceed the demand within the United States. FEMA recognizes that there may no longer be a need to disrupt the supply chain of such materials and require that the entire domestic production of these items be allocated for domestic use as scarce or threatened covered materials.
If you believe you have a surplus of a covered material and can demonstrate a good-faith and unsuccessful attempt to sell the material domestically, you may submit a request to FEMA to allow the material to be exported. Please submit a Letter of Attestation to NBEOC@max.gov, describing:
- The material you wish to export;
- The commercially reasonable efforts you have made to market and sell the material domestically;
- The delta, with specificity, between the domestic demand and the domestic production; and
- How the proposed export volume will not interfere with continued satisfaction of domestic demand.
FEMA will review submitted Letters of Attestation and make every effort to provide parties with a Letter of Decision within 3 business days of receipt of a Letter of Attestation.