On December 31, 2020, the Federal Emergency Management Agency (“FEMA“) issued a temporary final rule extending and modifying export restrictions on certain types of medical supplies and personal protection equipment products (“PPE Products“) used in response to the COVID-19 global health pandemic. The new rule became effective December 31, 2020; extends previously-imposed export restrictions on covered PPE Products to June 30, 2021; and adds certain types of syringes and needles to the list of covered PPE Products. We have previously authored blogs on the original FEMA rule, the exemptions from export restrictions, and a previous modification to the original FEMA rule.
FEMA first imposed export restrictions on certain PPE Products on April 7, 2020, to reserve supplies for domestic use to combat the COVID-19 pandemic, as described in our blog post here. These covered PPE Products included certain respirators, surgical masks, gloves, and surgical gowns. The new FEMA rule expands the list of covered PPE Products to include certain syringes and hypodermic needles, in light of the high rate of influenza vaccine administration and the rollout of the COVID-19 vaccines. In addition, the new rule clarifies the PPE surgical masks category. The current list of covered PPE Products includes:
- 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;
- PPE surgical masks as described by 21 CFR 878.4040, including masks that cover the user’s nose and mouth providing a physical barrier to fluids and particulate materials, that meet fluid barrier protection standards pursuant to— (i) ASTM F 1862; and (ii) Class I or Class II flammability tests under CPSC CS 191–53, NFPA Standard 702–1980, or UL 2154 standards;
- PPE nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (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 as described by 21 CFR 880.5860, 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, Pub. L. 106–430, 114 Stat. 1901 (Nov. 6, 2000).
All previous blogs posts on trade restrictions imposed throughout the COVID-19 pandemic can be found here. Baker McKenzie’s COVID-19 Product Import/Export Review (“COVID-19 PIER“), a multijurisdictional tracker for trade restrictions imposed worldwide, can be found here.
The authors acknowledge the assistance of Ryan Orange in this blog post.