September 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 announced they are delaying the deadline for use of the Document Image System (DIS) as a method to submit the CBP Form 1302A Cargo Declaration. The new deadline is April 1, 2025.
  • CBP seized $268,000 in unapproved FDA drugs in Cincinnati.
  • Wilmington CBP officers seized $151k in counterfeit designer brand name handbags.
  • CBP announced they are centralizing drawback functions under one Center of Excellence and Expertise (Center). Effective October 1, 2024, Drawback Specialists and their respective functions will be managed by the Houston Field Office under the Petroleum, Natural Gas and Minerals (PNGM) Center.
  • CBP published a new Air Cargo Advance Screening (ACAS) implementation guide.
  • A subgroup of the Commercial Customs Operations Advisory Committee (COAC) Secure Trade Lanes Subcommittee laid out eight recommendations for how to improve communications among CBP’s Centers of Excellence and Expertise, brokers and other trade entities.

United States Trade Representative (USTR)

  • USTR issued a federal register notice announcing a docket for public comments on proposed tariff increases following the four-year 301 review. The docket opened on September 23, 2024 and will close on October 22, 2024.
  • USTR announced an enforcement action under the United States-Peru Trade Promotion Agreement (PTPA) Forest Sector Annex. USTR requested the Government of Peru to verify that five timber shipments exported to the United States from Peru complied with applicable Peruvian […]
By |2024-09-28T13:51:57-04:00September 28, 2024|Snapshot|0 Comments

BIS Issues Final Rule on VSD Policies and Penalty Guidelines

BIS recently issued a final rule to amend the Export Administration Regulations (EAR), making several changes to their Voluntary Self Disclosure (VSD) policies, as well as updates to guidance on penalty determinations.

The rule codifies previously announced policy changes through several Policy Memoranda including an April 2023 memorandum on voluntary-self disclosures, and a June 2022 memorandum on strengthening administrative enforcement.

Revisions to Voluntary Self-Disclosures

The rule makes both substantive and procedural changes to the VSD policies:

  1. Addition of non-disclosure as an aggravating factor – the new rule makes clear that BIS will consider a deliberate decision to not disclose a violation as an aggravated factor when determining what administrative sanctions will be imposed.
  2. New dual track for processing VSDs – one track for minor or technical violations, the other for significant violations.
  3. Authorizes any person (not just the party submitting a VSD) to notify the Director of BIS’s Office of Export Enforcement (OEE) that a violation has occurred and to request permission to engage in corrective activities.

Revisions to Penalty Guidelines

This rule makes several changes to the BIS Penalty Guidelines, including:

  1. Changes the base penalty caps:
    1. Non-egregious VSD cases: was $125,000, now one-half of the transaction value.
    2. Non-egregious cases that are not initiated by a VSD: was $250,000, now the full transaction value.
  2. Permits BIS to use  non-monetary penalties to resolve cases that are not egregious and have not resulted in national security harm, but rise above the level of cases warranting a warning letter.
  3. Removes from the BIS […]

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 August 2024 monthly update. Highlights: 
    • Stopped 400 shipments  or further examination based on the suspected use of forced labor. 
    • Identified estimated duties of nearly $7.5 billion. 
    • Seized 1,997 shipments that contained counterfeit goods. 
  • CBP provided examples of unacceptable vs acceptable cargo descriptions. The agency said this list will continue to be expanded as unacceptable descriptions are identified and acceptable descriptions are further refined. 
  • CBP has introduced a new benefit for Customs Trade Partnership Against Terrorism (CTPAT) participants. This benefit allows the use of Foreign Trade Zones (FTZs) to store goods that are subject to potential forced labor enforcement actions. 
  • CBP officers seized 277 counterfeit Lululemon Everywhere Belt bags in Delaware, that had they been authentic would have been worth about $13,000. 
  • The United States signed a Customs Mutual Assistance Agreement (CMAA) with the Republic of Uzbekistan, strengthening law enforcement and Customs support between the two nations.  
By |2024-09-23T09:15:32-04:00September 20, 2024|Snapshot|0 Comments

FDA’s Proposed New National Drug Code – What You Need to Know

The Food and Drug Administration (FDA) is proposing to amend their regulations governing the format of the National Drug Code (NDC). The NDC is a standard for uniquely identifying drug products marketed in the United States. The current standard has several acceptable formats. If the proposal is finalized, it will standardize the format of all NDCs.

What is the NDC?

The National Drug Code is a unique, three-segment identifier that the FDA assigns to each drug on the U.S. market. It’s a universal product identifier that appears on all prescription and over-the-counter medication packages and inserts.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

  • 4-4-2
  • 5-3-2
  • 5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- digits and 2 in 11-digits. There may be confusion […]

By |2024-09-20T10:04:53-04:00September 20, 2024|U.S. Food and Drug Administration (FDA)|0 Comments

USTR Finalizes Action on 301 Tariffs

The United States Trade Representative (USTR) announced final tariff modifications following their statutory review of the Section 301 investigation of the People’s Republic of China’s (PRC) Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation. The final modifications include tariff increases on several products including critical minerals, batteries, and semiconductors.

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 […]

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