The U.S. Department of Homeland Security’s Federal Emergency Management Agency (“FEMA”) has issued a Federal Register notice extending and modifying the temporary final rule (“Rule”) establishing export restrictions on certain types of personal protective equipment (“PPE”) products and respirators (“Covered Products”) used in the response to the COVID-19 pandemic.  (For more information on the April 7, 2020 Rule and its exemptions, please see our Updates dated April 7 and April 22.)  Effective August 10, 2020, the Rule now covers four categories of items — instead of six — and will remain in effect until December 31, 2020.

Per the notice, the list of Covered Products identified in the original Rule was modified to reflect current domestic needs, will be allocated for domestic use and may not be exported from the United States without explicit FEMA approval.  As of August 10, 2020, the Covered Products are:

  1. Surgical 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;
  2. PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials;
  3. PPE nitrile gloves, including those defined at 21 C.F.R. Section 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes; and
  4. Level 3 and 4 surgical gowns and surgical isolation gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by surgical gown barrier performance based on AAMI PB70.

U.S. Customs and Border Protection (CBP) will continue to detain the shipments of Covered Products temporarily, during which time FEMA will determine whether to return for domestic use, to issue a rated order, or to allow the export of part or all of the shipment.  All of the exemptions and procedures applicable to the original rule previously identified by FEMA will remain in effect.