On Monday, August 10, 2020, the Federal Emergency Management Authority (FEMA) announced that it would continue to halt the export of certain personal protective equipment (PPE) until December 31, 2020. With this announcement, FEMA also modified the list of covered PPE subject to the rule.
Initially, on April 10, 2020, FEMA announced it would halt exports of certain covered PPE. On April 21, 2020, it announced specific exemptions from this general halt. For more information on the original halt and exemptions, please see our previous client alerts. The original halt concerned only the following PPE:
- N95 Filtering Facepiece Respirators.
- Other Filtering Facepiece Respirators (N99, N100, R95, R99, R100 or P95, P99, P100).
- Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges.
- PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials.
- PPE gloves or surgical gloves.
In its announcement, FEMA maintained the original exemptions from its April 21, 2020 notice. Additionally, it modified the list of covered PPE to narrow two of the designations, removed two of the designations, and added a designation. As a first step, FEMA narrowed the designations of the covered respirators and gloves.
Next, FEMA clarified that the covered PPE 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.” FEMA added for clarification the term “surgical” because demand is limited to surgical respirators, rather than industrial ones.
FEMA also narrowed the scope of the covered PPE or surgical gloves to nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and other such nitrile gloves intended for the same purposes.
FEMA removed the designations for other filtering respirators, as well as elastomeric, air-purifying respirators and appropriate particulate filters/cartridges. Finally, FEMA added designations for Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB7014 and ASTM F2407–0615 and are classified by Surgical Gown Barrier Performance based on AAMI PB70.
Separately, FEMA is requesting comments on its letter of attestation process, which it requires for use of many of the exemptions from its general halt. Comments are due by September 15, 2020. Faegre Drinker would be pleased to assist with preparing and submitting comments.
For more information on how this may affect your company’s exports of PPE, please contact Mollie Sitkowski, Kathi Murphy, or any other member of Faegre Drinker Biddle & Reath LLP’s Customs and International Trade Team.
Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.