
Impact of House passed legislation on health industries organizations
Summary of the impact of House passed legislation on the pharmaceutical, life sciences, medtech and health services sectors including PwC key observations.
April 2024
US Customs and Border Protection (CBP) on March 18 published a Federal Register Notice adopting as final the interim amendments (with changes) to the regulations implementing procedures for investigating claims of antidumping and countervailing duties (AD and CVD) evasion. The final regulations take effect April 17, 2024.
Additionally, on March 25, 2024, the International Trade Administration (ITA) of the US Department of Commerce (Commerce) published a Federal Register Notice implementing final rules amending its regulations “to enhance, improve and strengthen its enforcement and administration” of the AD and CVD laws. The final regulations take effect April 24, 2024.
Meanwhile, on March 11 CBP announced that it launched a dynamic statistics dashboard focusing on Enforce and Protect Act (EAPA) actions. CBP has updated the mechanism for reporting suspected AD and CVD evasion, breaking out the portal for EAPA violations from other trade violations on its Trade Violations Reporting webpage.
In line with the increased focus on AD and CVD enforcement, the United States Attorney for the Western District of Washington announced that the US Department of Justice, on behalf of CBP, and Yakima Products Inc. (Yakima Products) have resolved allegations that Yakima knowingly failed to pay required antidumping and countervailing duties on extruded aluminum components imported from the People’s Republic of China (China).
Changes to the AD and CVD enforcement regulations signal a renewed focus on this priority trade issue. CBP’s new EAPA allegations portal and dashboard also reflect the agency’s increasingly aggressive stance with respect to AD/CVD evasion. Moreover, CBP’s announcement of the settlement with Yakima Products is further evidence of a shift in its treatment of AD and CVD evasion allegations. This is directly relevant to all taxpayers that import goods potentially subject to AD or CVD orders.
All companies importing goods that are potentially subject to AD and/or CVD orders should review their procedures for determining whether their goods are subject to, and the correct rates for, any applicable AD or CVD orders.
For more information on the CBP’s renewed approach to trade facilitation and enforcement, including with respect to AD and CVD, see this page on the CBP website.
The Federal Register Notice on the final regulations for investigating claims of AD and CVD evasion includes a summary of the public comments submitted, and CBP’s responses, clarifications, and resulting changes to the interim regulations.
Notably, the final rule added an administrative protective order (APO) process, allowing for representatives of the parties to an EAPA investigation access to certain business confidential information obtained by CBP (see proposed changes to 19 C.F.R. § 165.4). Other key changes from the interim regulations include the addition of illustrative examples (e.g., “transshipment, misclassification, and/or undervaluation of covered merchandise”) to the regulatory definition of “evade or evasion” (see proposed changes to 19 C.F.R. § 165.1), and clarification that CBP will reject any allegations lacking a requisite proof of execution of a power of attorney for agents (see proposed changes to 19 C.F.R. § 165.3(a), (e)-(f)). In adopting the final regulations, CBP also noted that:
Observation: The trade community should be on notice that CBP has taken an aggressive stance on AD and CVD enforcement. Availability of an APO process and access to business confidential information should increase the ability of parties in EAPA investigations to respond to or rebut AD and CVD evasion allegations. However, parties other than those alleging EAPA violations still are not allowed to participate in the first 90 days, and non-cooperative entities can face adverse inferences.
The Federal Register Notice adopting amendments to the ITA regulations under 19 C.F.R. Part 351 also includes a summary of the public comments submitted, the ITA’s responses or clarifications, and resulting changes to the proposed regulations.
As set forth in the Federal Register Notice, the stated purpose of the ITA’s amendments is “to improve, strengthen and enhance the enforcement and administration of the AD/CVD laws, make such enforcement and administration more efficient, and to address factors which distort costs and prices.” Notably, the ITA’s final rule eliminates a current regulation prohibiting the countervailing of certain transnational subsidies. Key enforcement mechanisms codified under the amended regulations also include:
In relation to scope rulings and circumvention inquiries, the final rule clarifies that the ITA may issue a scope clarification (i.e., interpretation of specific language in the scope of an order and addresses other scope-related issues) in any segment of a proceeding, and that such clarifications will not always be published in the Federal Register. Scope clarifications “may take the form of an interpretive footnote to the scope when the scope is published or issued in its instructions to CBP, in a memorandum issued in an ongoing segment of a proceeding, or, at the discretion of the Secretary, in a Federal Register document providing parties with at least 30 days to file comments with the Secretary.”
The final rule also allows interested parties (other than the applicant or a requestor) opportunities to submit comments on the adequacy of applications or to provide new factual information to rebut, clarify, or correct facts on the record. Additionally, the ITA clarified that it will only issue scope rulings on merchandise that has not yet been imported if that merchandise has been commercially produced and sold.
Other important considerations for the trade community include the ITA’s clarification of what information must be submitted on the official record of AD and CVD proceedings to be considered, and requirements for filing “Notices of Subsequent Authority” to assert that a new Federal court or Commerce decision impacts arguments before the ITA.
Observation: Importers and other parties interested in AD and CVD proceedings should be aware of the new provisions, and should be sure to examine current record scope language in AD and CVD cases for scope clarifications that are not published in the Federal Register.
According to CBP, the EAPA dashboard is the latest in a series of actions to improve the transparency and effectiveness of CBP’s trade enforcement efforts, specifically those regarding evasion of AD and CVD. According to CBP, AD and CVD “address unfair trade practices by providing relief to U.S. industries and workers that are ‘materially injured,’ or threatened with injury, due to imports of like products sold in the U.S. market at less than fair value (AD), or subsidized by a foreign government or public entity (CVD).”
According to the CBP announcement, members of the public and trade community can use the new EAPA dashboard to explore updated data and global trends on AD and CVD evasion allegations that CBP receives. The EAPA dashboard is available on CBP.gov at Enforce and Protect Act (EAPA) Statistics | U.S. Customs and Border Protection (cbp.gov); it is separate and distinct from the dashboard for other types of alleged trade violations (i.e., e-Allegations Statistics | U.S. Customs and Border Protection (cbp.gov)).
CBP explained that “The Enforce and Protect Act dashboard offers a transparent platform for stakeholders to track the volume, types, and geographic locations of antidumping duty and countervailing duty evasion allegations.” Notably, the dashboard currently indicates that the AD and CVD evasion tactic most often employed is transhipment of China-origin goods.
The EAPA regulations and portal allow the trade community to file allegations of evasion of AD and CVD and to participate in an on-the-record investigation.
Observation: The separation of the EAPA allegations portal and dashboard from other types of trade violations emphasizes CBP’s increased focus on AD and CVD evasion as a priority trade issue.
For prior AD/CVD coverage, see PwC Tax Insight, United States continues duty investigations regarding varied products from numerous countries, September 18, 2023.
Under the settlement agreement, Yakima does not admit wrongdoing, but seeks to resolve the matter to avoid the delay, uncertainty, and expense of protracted litigation. Pursuant to the settlement, Yakima will pay $3 million, of which $1,325,000 is restitution, over a one-year period.
The unsealed complaint alleges that Yakima acted fraudulently by submitting a voluntary prior disclosure of tariff classification errors in its import entries to CBP. The disclosure addressed tariff classification errors only, and not underpayment of AD or CVD. However, the complaint alleges that in making the disclosure Yakima certified that the disclosure set “forth, to the best of the disclosing party’s knowledge, the true and accurate information or data that should have been provided.” The unsealed complaint further alleges that Yakima knew when making the certification that certain products imported under entries covered by the disclosure were subject to AD and CVD, and that they had not been entered as such.
Notably, the “certification” alleged in the complaint does not appear to have been made explicitly by Yakima. Instead, the complaint appears to be relying on CBP regulations requiring that:
The trade community generally has interpreted this regulatory provision as requiring only that the person concerned discloses the circumstances of the violation(s) they choose to disclose, along with information needed to correct the violation(s) they have elected to disclose. The basis for this understanding is, in part, informal CBP guidance stating that the disclosing party can “determine the scope of the prior disclosure.” CBP Informed Compliance Publication (hereinafter “ICP”), What Every Member of the Trade Community Should Know About: Prior Disclosure, p.12 (Aug. 2017). Additionally, CBP regulations also provide that “violations not disclosed or covered within the scope of the party's prior disclosure that are discovered by Customs … shall not be entitled to treatment under the prior disclosure provisions.” 19 C.F.R. § 162.74(h).
Observation: While Yakima Products did not admit to any wrongdoing, and there is no indication of how the court would have ruled on the complaint, importers should be mindful of these arguments when considering future voluntary disclosures of violations to CBP.
Summary of the impact of House passed legislation on the pharmaceutical, life sciences, medtech and health services sectors including PwC key observations.
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