The recent outbreak of the novel coronavirus, named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2), and the disease it causes, “Coronavirus Disease 2019” (COVID-19), has strained the global supply of various types of personal protective equipment (“PPE”), such as N95 masks, medical gloves and gowns.  These supplies are necessary for medical professionals in the trenches on the frontlines to diagnose and treat suspected or confirmed cases of COVID-19.  Yesterday, the U.S. Federal Drug Administration took action to relax customs clearance procedures related to certain types of PPE including the N95 masks, and today, the United State Trade Representative opened a new docket for comment to exclude medical products from the U.S. – China Section 301 ad valorem tariffs.  If you are importing PPE, like N95 masks, Earp Cohn P.C. is here to help.

The most recent estimates indicate that the U.S. will need more than 3.5 billion N95 respirator masks over the course of the next year and the Strategic National Stockpile contains only 13 million.  Hospitals around the country (and world) are rationing these supplies and instructing staff to take measures to reuse or conserve the use of this necessary protective equipment; in short, U.S. medical providers are scrambling to source supplies of these N95 masks as inventories dwindle.  Much of the global supply of N95 masks is manufactured in and sourced from China.

Under normal times, importers of certain personal protective products and devices, such as N95 masks, must clear customs through a process involving both U.S. Customs and Border Protection (“CBP”) and the FDA.

On March 24, 2020, FDA took action to facilitate customs clearance and increase supplies to support the U.S. response to the Coronavirus and COVID-19 disease by relaxing procedures and minimizing the delay of the importation of certain PPE like N95 masks for use by the general public during emergencies.

The FDA has listed the below products as qualifying for an Emergency Use Authorization to expedite customs clearance.

• FDA Code: NZJ (Masks/Respirators—N95 Masks for use by the general public in health emergencies)
• FDA Code: OTG (Diagnostic Test—Non-Sars Coronavirus Multiplex Nucleic Acid Assay)
• FDA Code: QKO (Diagnostic Test—Reagent, Coronavirus Serological)
• FDA Code: QJR (Diagnostic Test– Reagents, 2019-Novel Coronavirus Nucleic Acid)

A few weeks ago, the United State Trade Representative also excluded various types of PPE, including certain types of N95 masks and other products necessary to effectively combat COVID-19, from the U.S.-China Section 301 ad valorem duties or tariffs to remove any undue economic barriers to sourcing supplies.

• Excluding soap, labware, medical gloves, antibacterial wipes, disposable hospital gowns and surgical drapes;
• Excluding plastic gloves under HTSUS 4015.19.1010;
• Excluding single-use face masks and medical masks, cotton sponges, disposable pill-dispensing cups, molded surgical bowls, gel pads, single-use sterile drapes and disposable shoe covers, and single-use hot and cold packs.

Today, the USTR published an announcement that it would be opening a new docket to solicit comments in an effort to decide whether to modify the present tariffs on China-origin goods to remove duties on additional medical care products.

Earp Cohn P.C. is actively working with clients to navigate legal requirements and mitigate risk while assisting with importing personal protective equipment to supply the general public and medical professionals with critical equipment to continue the fight against COVID-19.

Please contact your Earp Cohn lawyer or a member of our International Law practice group for help with the process.