On December 31, 2020, the U.S. Department of Homeland Security’s Federal Emergency Management Agency (“FEMA”) published a temporary final rule (“Rule”) that extends and modifies the most recent rule issued on August 10, 2020 to continue to restrict the exports of the four categories of personal protective equipment (PPE) and respirators as well as a new fifth category of specific syringes and hypodermic needles, due to increased demand for influenza and COVID-19 vaccines (“Covered Materials”). For more information on the previous rules, please see Updates dated April 7, April 22, and August 10. The new Rule expires on June 30, 2021.
Per the Rule, the list of Covered Materials was modified to reflect current domestic needs. The Covered Materials will be allocated for domestic use and may not be exported from the United States without explicit FEMA approval. As of December 31, 2020, the Covered Materials are:
- Surgical N95 filtering facepiece respirators;
- PPE surgical masks, including masks that meet the fluid barrier protection standards pursuant to ASTM F 1862 and Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980 or UL 2154 standards;
- PPE nitrile gloves, including exam gloves, surgical gloves, and such nitrile gloves intended for the same purposes;
- 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; and
- Syringes and hypodermic needles (whether distributed separately or attached together) that are either: (i) piston syringes that allow for the controlled and precise flow of liquid that are compliant with ISO 7886-1:2017 and use only Current Good Manufacturing Practices (CGMP) processes; or (ii) hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act.
U.S. Customs and Border Protection (CBP) will continue to detain the shipments of Covered Materials 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 exemptions and procedures previously applicable and identified by FEMA will remain in effect. For more information on the exemptions to this Rule, please see Update dated April 21, 2020.