August 12, 2020

Export Restrictions on Personal Protective Equipment Extended, Amended

The Department of Homeland Security has amended and extended its prohibition on exports of personal protective equipment being used to treat COVID-19 without explicit approval by the Federal Emergency Management Agency.
This prohibition has been lifted with respect to the following products.
– other filtering facepiece respirators (e.g., those designated as N99, N100, R95, R99, R100, P95, P99, or P100), including single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level
– elastomeric, air-purifying respirators and appropriate particulate filters/cartridges
However, DHS has continued or modified this prohibition with respect to the following articles, which will be effective from Aug. 10 until Dec. 31.
– 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 (no change)
– PPE surgical masks, including those that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials (no change)
– PPE nitrile gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and other such nitrile gloves intended for the same purposes (latex and vinyl gloves are no longer subject to the restrictions)
In addition, DHS has newly added the following products to this prohibition, also effective from Aug. 10 until Dec. 31.
– 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 (newly added)
DHS states that before any shipments of restricted materials may leave the U.S., U.S. Customs and Border Protection will detain the shipment temporarily, during which time FEMA will determine whether to return for domestic use, issue a rated (purchase) order for, or allow the export of part or all of the shipment. FEMA will make such determinations within a reasonable time of being notified of an intended shipment and will endeavor to minimize disruptions to the supply chain.
However, FEMA will not purchase covered materials from shipments made by or on behalf of U.S. manufacturers with continuous export agreements with customers in other countries since at least Jan. 1, 2020, so long as at least 80 percent of such manufacturer’s domestic production of covered materials, on a per item basis, was distributed in the U.S. in the preceding 12 months. If FEMA determines that a shipment of covered materials falls within this exemption, such materials may be transferred out of the U.S. without further review by FEMA, although this exemption may be waived if FEMA determines that doing so is necessary or appropriate to promote the national defense. FEMA may also establish additional exemptions in the future.
The ten additional exemptions announced in April 2020 also remain in effect.
Failure to comply fully with this rule is a crime punishable by a fine of not more than $10,000, imprisonment for not more than one year, or both. In addition, pursuant to 18 USC 554, whoever fraudulently or knowingly exports or sends (or attempts to) from the U.S. any merchandise, article, or object contrary to any U.S. law or regulation, 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.