On August 10, 2020, the Federal Emergency Management Agency (FEMA) issued a temporary final rule extending and modifying FEMA’s previously imposed restrictions on the export from the United States of certain personal protective equipment (PPE Products) used in the response to the COVID-19 pandemic (“Extension Rule”). The original restrictions on exports of PPE Products imposed by FEMA were published on April 10, 2020. The Extension Rule became effective August 10, 2020, and will be in place until December 31, 2020 unless terminated or suspended earlier by the FEMA Administrator. Background on the original rule implementing restrictions on exports of PPE as well as certain exemptions can be found in our prior blog posts here, here, and here.
Under the Extension Rule, FEMA has modified the list of covered PPE Products by adding to, removing from, and modifying the prior list. The current list of products is as follows:
- N95 Filtering Facepiece Respirators: N95 filtering facepiece respirators continue to be restricted for export, but FEMA has clarified in the Extension Rule that the PPE Products covered items list only covers “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 Exam Gloves and Surgical Gloves: FEMA is narrowing the scope of PPE gloves to PPE nitrile gloves specifically defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and other such nitrile gloves intended for the same purposes.
- Surgical Gowns and Surgical Isolation Gowns: FEMA is adding 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 to the covered materials list.
- Surgical Masks: The list of covered materials will continue to include surgical masks.
FEMA is eliminating from the list of covered PPE Products other filtering facepiece respirators and elastomeric, air-purifying respirators and appropriate particulate filters/cartridges.
Exporters of PPE Products will likely continue to encounter delays at ports across the country, pending determinations by FEMA. Baker McKenzie continues to assist its client in preparing letters of attestation and related transactional documents to facilitate the export process and approval by FEMA of covered PPE Products that meet an exemption such as those outlined in our previous blog posts.