Customs Corner
Trade and Customs Updates
Government Shutdown Averted for Now, Funding Granted through November 15, 2023
The government has averted a shutdown in the hours leading up to the October 1st deadline. Congress passed a stopgap bill signed by President Biden which provided funding through November 15, 2023. There still is much work to be done by Congress over the next 45 days to ensure we are not in the same position in considering and preparing for the impact of another government shutdown. GEODIS will keep you posted on any updates as we progress over the next 45 days. Stay tuned.
FDA Updates Food Traceability FAQ with Information on Inspections and Product Tracing System
On 28 Sep 2023, the US Food & Drug Administration (FDA) has updated its Food Traceability FAQs to provide additional information about the FDA’s Product Tracing System and explain how the agency intends to conduct inspections starting in 2027. Â
The Food Traceability Final Rule was published in November 2022, establishing traceability recordkeeping requirements, beyond those in previously existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The new program was designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
Two New Chapters of Draft Guidance for the Preventive Controls for Human Food Rule
On 26 Sep 2023, the US Food & Drug Administration (FDA) has published two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, which was designed to help food facilities comply with the preventive controls for human food rule mandated under the Food Safety Modernization Act (FSMA). The two new chapters are Chapters 11 and 16 (Food Allergen Program and Acidified Foods, respectively).
Chapter 11 – Food Allergen Program explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens. It provides examples of how to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. The chapter also discusses circumstances in which, despite adherence to appropriate CGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided and options the firm can consider, including the voluntary use of allergen advisory statements when appropriate. The chapter complements the FDA’s recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, which reflects the agency’s risk-based and science-based approach for the evaluation of potential allergen violations.
Chapter 16 – Acidified Foods applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers, or cabbage that have an overall pH of 4.6 or below). It clarifies how these manufacturers can use procedures, practices, and processes that they have established to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.
APHIS eFile offers BRS Multi-year Permits
The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) has announced additional APHIS eFile flexibilities and assistance for BRS applicants including multi-year permits.
Applicants will now be able to submit multi-year interstate movement and import permits for plants and plant products. APHIS BRS has advised that applicants should follow the same application steps for new or unsubmitted permit applications and select a proposed expiration date of up to three years from your proposed effective date. Later in the year, APHIS BRS will also announce multi-year release permits for annual plants.
APHIS BRS has also unveiled a Standard Operating Procedure (SOP) template. This template can be used to accompany permit applications through eFile. This template outlines topics and suggested information to include in your SOPs to describe how applicants will maintain organisms developed using genetic engineering to prevent their unauthorized release, spread and/or persistence in the environment.
eFile accounts can be accessed at APHIS eFile.
CBMA Deadline for 2023 Assignments and Opening of 2024 Assignments
Assignments of CBMA tax benefits for products imported in calendar year 2023 must be submitted through myTTB no later than December 31, 2023. TTB’s regulations at 27 CFR 27.262(d) provide that assignments of CBMA tax benefits must be submitted on or before December 31 of the calendar year for which the CBMA tax benefits are assigned.Â
Additionally, assignments of CBMA tax benefits generally may be submitted through myTTB beginning on October 1 of the calendar year prior to the year for which the CBMA tax benefits are to be assigned.
Before foreign producers can submit 2024 assignments, they will need to confirm or update their ownership information in the myTTB Foreign Producer Registration and Assignment System. Foreign producers will be prompted to review their information when they log into the myTTB Foreign Producer Registration and Assignment System for the first time on or after October 2. Instructions will be available in myTTB, but are also available in CBMA FAQ CB-FP14.
Additional data on CBMA can be found at CBMA Imports at TTB.GOV
FDA Announces Reauthorization of Animal Drug User Fee
On 30 Sept 2023, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) were reauthorized under HR 5860 and signed into law. HR 5860 provides fiscal year appropriations to Federal agencies through 17 Nov 2023 for continuing projects of the Federal Government and extends several expiring authorities including ADUFA and AGDUFA.
The two user fee programs allow FDA to maintain a predictable and timely animal drug review process, while fostering innovation in drug development and expedite access to new therapies for food- producing and companion animals.
Fee rates and payment procedures for FY 2024 have not yet been published in the Federal Register.
Trade and Customs Reminders & Events
EVENT: Marine Fisheries Advisory Committee (MAFAC)
14-16 November 2023 from 08:30-05:00 PM EST
The webinar will provide an overview of the new regulations for customs brokers, which mandate a continuing education requirement to maintain an individual license. The webinar will present an implementation overview as well as the next steps for customs brokers to take to meet the upcoming program requirements.
BROADCAST: GEODIS Live Broadcast: Valuation and Taxes in Canada
Thursday, October 19, 2:00pm – 3:00pm (EDT)
The webinar will provide an overview of the new regulations for customs brokers, which mandate a continuing education requirement to maintain an individual license. The webinar will present an implementation overview as well as the next steps for customs brokers to take to meet the upcoming program requirements.
EVENT: Apparel Classification Workshop
Tuesday, November 7, 2023 – 10:00 AM to 1:00 PM ET
We look forward to seeing you at the USFIA Apparel Trade & Transportation Conference. If you are interested in classification issues, be sure to come to New York City early so that you can join us for a special pre-conference event. USFIA invites you to participate in a meeting with key National Import Specialists and gain a better understanding of the U.S. Customs & Border Protection classification process.
