Revision of PPE Export Restrictions by Fema

FEMA (Federal Emergency Management Agency) has announced a Temporary Final Rule extending the regulation and adjusting restrictions of exports of certain Personal Protective Equipment (PPE) until December 31, 2020.

As background,  FEMA published a temporary final rule in the Federal Register that allocated specific PPE and medical equipment for domestic use. These resources could not be exported from the USA without meeting certain conditions and the approval of FEMA. 

Please note the updated changes to the Temporary Final Rule that include:  

• Surgical N-95 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, including masks that cover the user's nose and mouth and provide a physical barrier to fluids and particulate materials;
• PPE 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.
• Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all the requirements in ANSI/AAMI PB70 and ASTM F2407 – 06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70.

Failure to comply with this rule is a crime punishable by a fine of not more than $10,000 or imprisonment for not more than one year, or both.

n addition, whoever fraudulently or knowingly exports from the United States, or attempts to export from the United States articles contrary to any U.S. law, or receives, conceals, buys, sells, or in any manner facilitates the transportation, concealment, or sale of such merchandise, article, or object, prior to exportation, knowing the same to be intended for exportation contrary to any U.S. law or regulation, faces up to 10 years’ imprisonment, a fine, or both, if convicted.

The rule is effective from August 10, 2020 through December 31, 2020. For assistance in product determinations / exemptions  and drafting Letters of Attestation, please email CWTSConsulting@craneww.com

For the Federal Register notice, please see here.