EU-UK Spotlight: Renewables, trade, and the global supply chain
On February 8, 2022, the Bureau of Industry and Security (“BIS”) published a Final Rule amending the Export Administration Regulations (“EAR”) to add 33 persons to the Unverified List (“UVL”) pursuant to § 744.15(c) of the EAR. These parties were added to the UVL because BIS was unable to verify the parties’ bona fides, since an end-use check could not be completed satisfactorily for reasons outside the U.S. Government’s control. The new additions include Wuxi Biologics Co., Ltd. and Wuxi Biologics (Shanghai) Co., Ltd. (collectively “Wuxi Biologics”), a significant contract development and manufacturing organization (“CDMO”) in China that partners with global pharmaceutical companies.
On February 8, 2022, BIS published a Final Rule amending the EAR that adds 33 persons in China to the UVL pursuant to § 744.15(c) of the EAR. The parties were added to the UVL since BIS was unable to verify their bona fides because an end-use check could not be completed satisfactorily for reasons outside the U.S. Government’s control.
The new additions include Wuxi Biologics, a major Chinese company that provides contract development and manufacturing services to global pharmaceutical companies. These additions to the UVL would impose new regulatory requirements on the export, reexport, or transfer of U.S-origin items (and certain foreign items with more than a de minimis amount of U.S.-origin content) to Wuxi Biologics.
The UVL (Supplement No. 6 to Part 744 of the EAR) contains the names and addresses of foreign persons who are or have been parties to a transaction involving the export, reexport, or transfer (in-country) of items subject to the EAR. Parties are added to the UVL when BIS is unable to verify the parties’ bona fides (i.e., legitimacy and reliability relating to the end use and end user of items subject to the EAR) through an end-use check (e.g., a pre-license check or a post-shipment verification) that cannot be completed satisfactorily for reasons outside the U.S. Government’s control. The reason for a particular addition to the UVL may – but does not necessarily have to – be related to the cooperation of the foreign party subject to the end-use check. The Final Rule notes that parties can be added to the UVL when BIS does not have sufficient information to establish that parties are involved in activities described in Parts 744 or 746 of the EAR, which prevents BIS from placing parties on the Entity List.
License exceptions cannot be used for exports, reexports, and transfers (in-country) involving a party or parties on the UVL. 15 C.F.R. § 740.2(a)(17). Exports, reexports, or transfers to UVL parties that do not require a license must include a UVL statement, and the exporters or reexporters to the transaction must maintain a record of this statement. 15 C.F.R. § 744.15(b). Requests for the removal of a UVL entry must be made in accordance with § 744.15(d) of the EAR.
The Final Rule adds the following individuals and entities to the UVL:
Per the Savings Clause in the Final Rule, items eligible for export, reexport, or transfer without a license or pursuant to a license exception before this regulatory action may be exported from the United States, reexported, or transferred before March 11, 2022 to the UVL listed persons under the previous license exception eligibility, as long as the shipments (i) are on dock for loading, on lighter, laden abroad an exporting carrier, or en route abroad a carrier to a port of export on February 8, 2022 and (ii) are made pursuant to actual orders. Any items not actually exported, reexported, or transferred before midnight on March 10, 2022 are subject to the requirements in 15 C.F.R. § 744.15.
Lastly, through this Final Rule, BIS changed the country name of “China” in the first column of the UVL to the “People’s Republic of China” to conform to the Entity List and Military End-User List.
Hogan Lovells would be pleased to advise on how these additions to the Unverified List may affect your business.
Authored by Ajay Kuntamukkala, Beth Peters, Ashley Roberts, and Hao-Kai Pai.