Customs Corner
Trade and Customs Updates
FDA Begins Cancelling Food Facility Registrations
In CSMS 55593773 dated 22 Mar 2023, the Food & Drug Administration (FDA) announced that as of 10 Mar 2023 it had ended its enforcement discretion and its requirement that food facilities provide the FDA with a Universal Facility Identifier (UFI) is now in full effect. FDA recognizes DUNS as the UFI.
When FDA opened the renewal period for Food Facility Registration Renewal on 01 Oct 2022, FDA required that a DUNS be provided as part of the renewal. Once the biennial renewal period closed on 31 Dec 2022, FDA began to enforce the requirement in 21 CFR 1.231(a)(3) and (b)(5) to verify the accuracy of the DUNS submitted by registrant. FDA also verified that the facility-specific address associated with the DUNS is the same address associated with the registration.
USDA announces Phase VII of the Lacey Act Enforcement
The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) is announcing the schedule of the next phase of Lacey Act declaration implementation. Phase VII will include a wide variety of materials and plant products, such as furniture, cork, and some essential oils that have not yet required
a declaration. APHIS launched an outreach campaign in October 2022 to provide information about the upcoming declaration implementation phase.
In Phase VII, Lacey Act declarations will be required for all remaining plant product Harmonized Tariff Schedule (HTS) codes that are not 100-percent composite materials. Importers of such items who do not currently file a Lacey Act declaration will likely need to file one once APHIS implements Phase VII. APHIS encourages importers to prepare in advance by becoming familiar with their supply chain and reviewing what information is necessary to file a declaration. APHIS’ Lacey Act web page provides a guidance.
APHIS is currently reviewing HTS codes to determine the complete list of materials and products that will be included in Phase VII. In fall 2023, APHIS will publish a list of affected HTS codes in the Federal Register and will require declarations for those product codes six (6) months later.
First enacted in 1900, the Lacey Act combats trafficking in illegally taken wildlife, fish, or plants. The Food, Conservation, and Energy Act of 2008 amended the Lacey Act to provide, among other things, that importers submit a declaration at the time of importation for certain plants and plant products. APHIS ensures compliance with the declaration requirement as part of its mission to protect the health and value of American agriculture and natural resources, and it began enforcing the declaration requirement on April 1, 2009. Since 2009, APHIS has been phasing in enforcement of the declaration requirement, as described in previous notices APHIS published in the Federal Register.
FDA Ends Voluntary Cosmetics Registration Program
The US Food and Drug Administration (FDA) has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective 27 Mar 2023 as a result of FDA’s plans to develop a program for submission of the facility registrations and product listings mandated by the
“Modernization of Cosmetics Regulation Act of 2022” (MoCRA). The VCRP was established in 1972 as a way for FDA to obtain the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution, voluntarily, from manufacturers, packers, and distributors of cosmetic products in commercial distribution. The VCRP was also open to foreign cosmetics companies whose products are exported for sale in the U.S.
FDA used the information from the VCRP to assist it in carrying out its responsibility to regulate cosmetics marketed in the U.S. It was not an approval system. Because the system was voluntary, the information provided through the VCRP did not present a complete picture of cosmetics in the U.S. marketplace.
Because MoCRA requires certain companies to register their facilities and list their products with FDA, FDA is creating a new system to handle the large number of submissions that will result. FDA therefore will no longer use the voluntary registration system and is no longer accepting and processing submissions to the VCRP.
FDA is requesting that cosmetics companies wait to register with FDA until they announce the availability of the new system. Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.
Summary:
- FDA has stopped accepting and processing submissions to the VCRP.
- FDA is developing a system for submission of the facility registrations and product listings mandated by MoCRA and will provide further updates on its forthcoming availability.
- Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.
For Additional Information
CITES Trade with Mexico suspended
The CITES Secretariat issued CITES Notification No. 2023/037 on 27 Mar 2023, announcing the trade suspension for all commercial trade with Mexico, effective immediately. As a result, the United States has implemented all CITES recommendations to suspend trade, including the import, export, and re-export of
any CITES species subject to a trade suspension.
Effective immediately, all shipments containing CITES specimens traded for commercial purposes under an import permit, export permit, or re-export certificate issued by Mexico for the species, are subject to the enforcement action.
The Endangered Species Act prohibits trade in specimens, contrary to the Convention on International Trade in Endangered Species of Wild Fauna & Flora (CITES). Article I of the Convention defines trade to mean “export, import, and introduction from the sea”. Article XIII designates the Secretariat to communicate to the parties when species in Appendix I and II are being adversely affected in trade or that the provisions of the Convention are not being implemented effectively.
An import permit, export permit, or re-export certificate issued for the species by the country under suspension is considered invalid and, therefore, will not be honored and the cargo will be refused admission into the US.
The complete list of Parties subject to a recommendation to suspend trade is available on the CITES website under Documents/Trade suspensions at https://cites.org/eng/resources/ref/suspend.php
packers, and distributors of cosmetic products in commercial distribution. The VCRP was also open to foreign cosmetics companies whose products are exported for sale in the U.S.
FDA used the information from the VCRP to assist it in carrying out its responsibility to regulate cosmetics marketed in the U.S. It was not an approval system. Because the system was voluntary, the information provided through the VCRP did not present a complete picture of cosmetics in the U.S. marketplace.
Because MoCRA requires certain companies to register their facilities and list their products with FDA, FDA is creating a new system to handle the large number of submissions that will result. FDA therefore will no longer use the voluntary registration system and is no longer accepting and processing submissions to the VCRP.
FDA is requesting that cosmetics companies wait to register with FDA until they announce the availability of the new system. Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.
Summary:
- FDA has stopped accepting and processing submissions to the VCRP.
- FDA is developing a system for submission of the facility registrations and product listings mandated by MoCRA and will provide further updates on its forthcoming availability.
- Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.
For Additional Information
Frequently Asked Questions
What do I do if my Food Facility Registration has been canceled?
Do NOT re-register your facility! To reinstate your Food Facility Registration (FFR) please follow the steps below:
Step 1: Obtain an accurate DUNS number
Step 2: After you have received a facility- address specific DUNS number, Request your Food Facility Registration (FFR) and DUNS to be confirmed
Email cfsanfoodfacilityregistration@fda.hhs.gov
Subject: DUNS accuracy verification
Body of the email:
- FFR number
- DUNS number
- FFR Section 2- Facility Name
- FFR Section 2 – address, city, State/Province, Mail/Zip code
Trade and Customs Reminders & Events
US Customs and Border Protection’s 2023 TFCS Summit
April 17-19
Sessions will include discussions highlighting the latest requirement updates and best practices for navigating today’s complex supply chain challenges.
NCSD ‘Petroleum Gases and Other Gaseous Hydrocarbons’ Webinar
April 17-19
Sessions will include discussions highlighting the latest requirement updates and best practices for navigating today’s complex supply chain challenges.
NCSD ‘Back to The Basics – What is a Men’s T-shirt and What Isn’t’ Webinar
April 17-19
Sessions will include discussions highlighting the latest requirement updates and best practices for navigating today’s complex supply chain challenges.
