Trade and Customs Updates
CSMS #58066785 Issued to Address ACE Out of Sequence A3/A1 Posting Codes
US Customs and Border Protection has issued CSMS# 58066785 addressing the out of sequence posting of the A3 and A1 codes when FDA prior notice is required.
CBP states in the CSMS that they “are aware posting codes A3/A1 are occasionally being sent out of order, we have identified a fix and will be implementing it on 10/21/2023, please contact your assigned client rep in the meantime if this issue is affecting you.”
Customs and Border Protection Adds Online Portal for FP&F Mitigation
CBP unveiled its newest eTool – a new online portal for filing mitigation petitions with its Office of Fines, Penalties & Forfeitures. This is a new option for importers and exporters, their legal representatives or customs brokers to request relief from penalty notices, demands for liquidated damages and seizure notices. Additional capabilities of the new portal include an option to search pending petitions submitted and to attach documents to support the petition being filed. Attachments can be up to 25 MB per document or 50 MB total.
Usage of the portal is not mandatory and importers, exporters, customs brokers and legal representation will still have the option of submitting their petitions via paper. The portal is available at https://epet.cbp.dhs.gov/main.
APHIS Announces Draft Guide Available for Public Comment
On 12 Oct 2023, the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) is inviting public comment on the draft Guide for Submitting Data for Reports and Notices in eFile for the next 60 days.
The guide is available now for review and should be used to submit public comments. APHIS BRS is looking for comments to identify any areas that require further clarity. The comment period is open starting 12 Oct 2023, on the regulations.gov website at https://www.regulations.gov/docket/APHIS-2023-0078. All comments must be received by 11 Dec 2023 for APHIS BRS to be considered before issuing the final version of the Guide.
CSMS # 58043575 Issued Regarding FDA’s Retirement of Subclass Y Under Industry Code 54
Per CSMS# 58043575 The Food and Drug Administration (FDA) will be retiring subclass code Y “Not Elsewhere Classified (NEC)” for Industry Code 54-Vit/Min/Prot/Unconv Diet(Human/Animal) come December 12, 2023.
The CSMS reads as follows:
Filers are encouraged to stop utilizing Subclass code Y as soon as possible to facilitate a timely admissibility decision. All other subclass codes in Industry Code 54 remain available for use. Select the appropriate code for the product being offered for import.
A/Human Food Enrichment (Further Processing)
B/Human Food Dietary Suppl, 1 Ingred
C/Human Food Dietary Suppl, Multi Ingred
D/Human Non-Rx 1 Ingr
E/Human Non-Rx Comb Ingr
F/Human RX 1 Ingr
G/Human RX Comb Ingr
I/Investigational Drug Use
L/Animal Food Nutritional INGR (Further Processing)
M/Animal Food Supplement (Finished Form)
N/Animal Non-Rx Drug
R/Animal Rx Drug
Human Foods: A, B, C
Animal Foods: L, M
Animal Drugs: N, R
Human Drugs: D, E, F, G
Investigational Drug Use: I
If your product falls under multiple Industry Code 54, subclass codes (e.g., both a human use food product and an animal food use product) use the subclass code that applies to the primary intended use of the product.
The subclass code Y will no longer be available for use 60 days from the issuance of this CSMS message. After this date, use of subclass Y under industry code 54 will result in an invalid product code reject from FDA. The end-date will be on December 12, 2023.
Please send any questions or concerns to the email address for the Product Code Builder Feedback: PCBFeedback@fda.hhs.gov
For product code identification, refer to the FDA Product Code Builder.
FDA Updates Prior Notice of Imported Food Questions & Answers
On 13 Oct 2023, the US Food & Drug Administration (FDA) has updated its Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry. The guidance document updates the current version by including three additional questions.
FDA is also making other technical amendments to the guidance due to the expanded capabilities of the Automated Commercial Environment (ACE) system and FDA’s 2017 technical amendments to the prior notice rule (82 FR 15627), such as removing references to requirements that certain prior notice submissions be submitted in FDA’s Prior Notice System Interface (FDA PNSI), and updating outdated links and FDA contact information.
FDA Publishes Additional Guidance for Cosmetics Registrations
On 13 Oct 2023, the US Food and Drug Administration (FDA) published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetics product facility registrations and product listings are now included within the SPL framework. The Implementation Guide can be used to develop SPL tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software including Xforms, for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
FDA also intends to make the Cosmetics Direct electronic submission portal available in the future at https://direct.fda.gov/. Cosmetics Direct will be an FDA provided SPL authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the ESG.
Additional Information on these topics can be found below:
FDA Publishes YouTube Video on Importing Foods
On 16 Oct 2023, the US Food and Drug Administration (FDA) published a new YouTube video on FDA’s importation of Human Foods. This was announced in CSMS #58071580.
The video, titled “Importing FDA-regulated products: Human Foods” is part of a series of the FDA videos that provide outreach and commitment to educating the public on securing the nation’s food supply.
The video provides helpful information on the FDA import process for food including:
- Researching The Requirements
- Food Facility Registration
- Food Safety Standards
- Labeling and Nutrition
- Prior Notice
- Additional Requirements
- Declaring the Shipment
- FDA Admissibility Decision
EPA Reporting Required for Per and Polyfluoroalkyl Substances (PFAS)
The Environmental Protection Agency has published the final rule in the Federal Register that details the requirement for manufacturers and importers to report perfluoroalkyl and polyfluoroalkyl substances (PFAS), covering the past 12 years of imports. The reporting must cover any product that contains PFAS otherwise known as “forever chemicals”, which cover more than 9,000 unique chemical substances. The reporting must be completed through EPA’s Central Data Exchange by May 8,2025.
This requirement will have a widespread impact across many commodities and as many states move towards banning the use of PFAS all together some commodities must even consider the impact PFAS can have on the amount of duties paid at the time of import. For example, PFAS are used in the water-resistant coating for apparel, which for certain apparel items can result in a lower duty rate. Per the USHTS the water resistance must be the result of a plastic or rubber application. Legislation has been introduced by Sen. King (I-ME) to change the chapter note under chapter 62 to remove the requirement that the water resistance be the result of plastic or rubber coating. (S.1413)
Trade and Customs Reminders & Events
EVENT: Apparel Classification Workshop
07 Nov 2023 10:00 AM-1:00PM 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.
EVENT: USDA DS Stakeholder Meeting
15 Nov 2023 1:00 PM-4:00PM ET
The US Department of Agriculture’s Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual Stakeholder Meeting on Wednesday, 15 Nov 2023, from 1:00-4:00 pm (EST).
SAVE THE DATE: US Customs and Border Protection – Trade Facilitation and Cargo Security Summit
26-28 Mar 2024
US Customs and Border Protection – Trade Facilitation and Cargo Security Summit will be held on March 26 – 28.