October 2024

Customs and Trade News Weekly Snapshot

Here is a recap of the latest customs and international trade news:       

Customs and Border Protection (CBP) 

  • CBP released the September 2024 monthly update. Highlights: 
    • Identified $7.6B in duties to be collected 
    • Stopped 425 shipments for further examination based on the suspected use of forced labor 
    • Seized 1,873 shipments that contained counterfeit goods 
  • CBP released an updated version of the Air Cargo Advance Screening – Implementation Guide (ACAS-IG) Version 2.3.3. 
  • CBP and CPSC seized $61,000 in infant products that were determined to be unsafe for entry due to high lead paint content and choking hazards.  
  • On October 26, 2024, CBP plans to retire the filer and shipper/consignee legacy ACE portal account views. 

Bureau of Industry and Security (BIS) 

  • BIS added 26 entities to the Entity List for activities contrary to U.S. national security and foreign policy.  
  • BIS announced the removal of Canada-based Sandvine Incorporated from the Entity […]
By |2024-10-25T13:10:49-04:00October 25, 2024|Snapshot|0 Comments

ICYMI: USTR Opens Exclusion Process for Domestic Manufacturing Machinery

On October 15, 2024, the Office of the United States Trade Representative (USTR) announced that it is opening a process for interested persons to request that certain machinery be temporarily excluded from Section 301 duties in the Investigation of China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation.

301 Investigation Background

In August 2017, USTR initiated an investigation into China’s acts, policies, and practices related to technology transfer, intellectual property, and innovation. The agency released a report of its findings in March 2018 and in June 2018 began imposing additional duties on products of China in four tranches.

Under the Trade Act of 1974, the USTR is required to conduct a four-year review if they receive an appropriate request to continue an action taken under Section 301. The agency is required to review:

  • (A) the effectiveness in achieving the objectives of section 301 of (i) such action, and (ii) other actions that could be taken (including actions against other products or services), and
  • (B) the effects of such actions on the United States economy, including consumers.

In accordance with this requirement, USTR announced in May 2022 that it was commencing this review and opened a docket for interested persons to submit comments.

The agency received nearly 1,500 comments. Throughout 2023 and early 2024, USTR and the Section 301 Committee (a USTR-led, interagency Trade Policy Staff Committee) held numerous meetings with agency experts to consider the comments received.

In May 2024, USTR issued a formal proposal in […]

Customs and Trade News Weekly Snapshot

Here is a recap of the latest customs and international trade news:        

Customs and Border Protection (CBP) 

  • CBP announced the publication of its re-vamped Forced Labor website. The re-design includes navigation improvements as well as a new enforcement page with statistics and dashboards. 
  • CBP modified the withhold release order (WRO) against disposable gloves produced by Brightway Holdings in Malaysia. Effective immediately, the U.S. will allow disposable gloves produced by the Brightway Group to enter the U.S. provided they are otherwise compliant with U.S. laws. 
  • A team of two CBP agriculture specialists at the Port of Brownsville intercepted a “First in Port” pest that had the potential to defoliate hundreds of species of trees and shrubs. 
  • CBP is now accepting applications to operate a Centralized Examination Station (CES) in the Area Port of Port Chicago. Applications to operate a CES must be received by 4 p.m. on Nov. 26.  
  • CBP published an updated ACE Development and Deployment Schedule. 

Bureau of Industry and Security (BIS) 

  • BIS added eight companies to its Unverified List after it was unable to […]
By |2024-10-18T12:21:57-04:00October 18, 2024|Snapshot|0 Comments

Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System

As of October 1, 2024, listing of over-the-counter (OTC) monograph drug products will not be able to be certified under the old marketing categories and old application number fields in FDA’s Electronic Drug Registration and Listing System (eDRLS). Instead, the listing of such products will need to include the current Marketing Category and Application Number values.

New Certification Requirements Background

The FDA utilizes the eDRLS for several key programs including drug quality reports, adverse event reports, and drug import and export compliance.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The law amended the Federal Food, Drug and Cosmetic Act (FD&C Act) and modernized the OTC drug review process.

The amendments required the FDA to update the marketing category and application number fields for OTC monograph drugs in the eDRLS.

eDRLS Field Updates

The change in current values to be used effective October 1st, 2024, are:

  • For the marketing category field, the categories “OTC monograph final” and “OTC monograph not final” are permanently replaced with the single term “OTC monograph drug,” to be used for nonprescription drug products marketed without an approved new drug application.
  • For the application number field, the use of OTC monograph CFR parts was discontinued starting October 2023 and the old submissions referencing the CFR parts must now be updated to include the appropriate Monograph ID.

As of October 1, 2024, drug listing records that refer to the old marketing categories and CFR parts citations will no longer be available for certification.

OTC drug […]

BIS Issues Guidance to Financial Institutions on Best Practices for Compliance with the Export Administration Regulations

The Department of Commerce’s Bureau of Industry and Security (BIS) recently published guidance for financial institutions containing several recommendations for complying with the Export Administration Regulations (EAR).

The guidance provides recommendations on steps financial institutions can take to minimize the likelihood of EAR violations. The recommendations focus on three key areas: due diligence best practices, reviewing transactions for red flags, and real-time screening.

Due Diligence Best Practices

The guidance recommends that financial institutions incorporate EAR related due diligence into their compliance and risk management and compliance processes. Due diligence should be conducted both before onboarding a new customer and as part of regular due diligence thereafter.

Specifically, BIS recommends that financial institutions:

  • Review customers against lists of persons subject to BIS’s end-user restrictions
  • Review customers – and, where appropriate, customers’ customers – against lists of entities that have shipped Common High Priority List (CHPL) items to Russia since 2023
  • Ask a customer to certify that it has controls in place to comply with the EAR if the customer is engaged in the export, reexport or transfer of items subject to the EAR and is on a restricted-party list
Review Transactions for Red Flags

The guidance recommends that financial institutions review transactions on an ongoing basis for red flags:

  • Purchases under a letter of credit that are consigned to the issuing bank, not to the actual end user.
  • Transactions involving entities with little to no web presence, such as a website or a domain based email account.
  • A customer lacks or refuses to […]
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