January 5, 2021

FEMA has published a Temporary Final Rule (TFR)

On December 31, FEMA published a Temporary Final Rule (TFR) in the Federal Register that allocated certain scarce and critical health and medical resources for domestic use to ensure needs are met for the American public during the COVID-19 pandemic. This TFR is an extension and modification of a TFR published on August 10, 2020, that extended and modified the initial allocation order issued on April 10, 2020. The TFR outlined the implementation of the President’s Memorandum, “Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use” issued on April 3, 2020.

This extension allows this rule to remain in effect, with certain modifications, through June 30, 2021.  To reflect changing circumstances, modifications were made to the types of exports of Personal Protective Equipment (PPE) that FEMA will review and may hold for domestic use.  Specifically, FEMA narrowed the scope of the surgical masks subject to the order (see below). Additionally, the agency added certain types of syringes and hypodermic needles to the order, so that these items may not leave the United States without explicit approval by FEMA.

Items subject to this allocation order include: 

  • Surgical N95 Respirators;
  • Surgical masks, specifically PPE surgical masks that meet fluid barrier protection standards pursuant to specific industry standards;
  • Nitrile gloves and exam gloves,
  • Surgical Gowns and Surgical Isolation Gowns; and
  • Syringes and hypodermic needles (whether distributed separately or attached together) that are either:
  • Piston syringes; or                         
  • Hypodermic single lumen needles with a safety feature

Any export of the above items should be carefully reviewed. There are several exemptions available, our consulting team can help review to ensure compliance. Please reach out to our group via cwtsconsulting@craneww.com with any questions.

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