Customs Corner: FDA Updates
29/06/2022Customs Corner issued on April 29th, 2022
Foreign Supplier Verification Program (FSVP) Importer Data Element Update
Today, in CSMS 51738135, the Food & Drug Administration (FDA) announced that effective 24 Jul 2022, FDA will end its temporary policy of permitting the use of the “entity code” of UKN (or unknown) in place of the Data Universal Numbering System (DUNS). This marks the end of the grace period that was put in place in 2018.
When the FSVP data requirements were introduced back in 2018, FDA required all importers to provide their Unique Firm Identifier (UFI) in accordance with 21 CFR 1.509(a). The DUNS was identified as the accepted form for the UFI, however, the agency recognized that as a new requirement, some factors may prevent importers from doing so. FDA, therefore, established a temporary policy that would enable FSVP importers unable to obtain a DUNS number to transmit the value “UNK” in the UFI field for shipments subject to FSVP entry requirements.
“Beginning July 24, 2022, the use of the entity identification code ‘UNK’ will no longer be an option,” FDA said. “Consistent with 21 CFR 1.509(a), the FSVP importer will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. CBP will reject an entry line of a food subject to the FSVP regulation when the importer’s DUNS number is not provided in the Entity Number field,” it said. The policy will apply only to entries with the affirmation of compliance (AoC) code FSVP, indicating the food is subject to FSVP requirements.
Importers that are do not currently have an established DUNS can reach out directly to Dun & Bradstreet to establish a DUNS free of charge. Importers can register for a DUNS either by going to their website (https://www.dnb.com/duns-number/get-a-duns.html) or by calling them at 866-705-5711.
For importers with multiple locations, each location should have its own DUNS. However, an importer may choose to provide Geodis with the one location where the FSVP documents are maintained and that will be the DUNS (and its associated address) that is submitted to FDA upon presentation of the import customs declaration.
If you have not previously advised GEODIS of your DUNS and you import FSVP-regulated goods, please reach out to your local GEODIS representative today to provide this information to prevent any delays in processing your imports.
Additional information on Providing Unique Facility Identifier for the Foreign Supplier Verification Program can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier
FDA Accredited Third-Party Certification Programs
The US Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.
The final rule for Accredited Third-Party Certification was issued in 2015 under the FDA Food Safety Modernization Act (FSMA). The rule establishes a voluntary program, known as the Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP), in which the FDA recognizes accreditation bodies that have the responsibility of accrediting third-party certification bodies. Accredited third-party certification bodies conduct food safety audits and certify that eligible foreign food entities and food produced by such entities, meet the applicable food safety requirements of the Federal Food, Drug, and Cosmetic Act and FDA regulations. An eligible entity is a foreign entity in the US import food supply chain that undergoes a food safety audit conducted by an accredited certification body under the Accredited Third-Party Certification Program.
The draft guidance will provide answers to frequently asked questions relating to the requirements of the Accredited Third-Party Certification Program, and is intended to assist accreditation bodies’, third-party certification bodies’, and eligible entities’ understanding of the regulation and program requirements.
Comments can be submitted in writing or electronically within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments at Regulations.gov, using Docket No. FDA-2022-D-0370
Additional information on FDA Accredited Third Party Program is available below:
- Key Facts About the Program
- Public Registry of Recognized Accreditation Bodies
- Public Registry of Accredited Third-Party Certification Bodies
FDA Food Safety and Culture Webinar
Food safety culture is one of the core elements in FDA’s New Era of Smarter Food Safety blueprint, which states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs, attitudes, and, most importantly, the behaviors of people and the actions of organizations.
To further this The FDA is continuing its webinar series on the Foodborne Outbreak Response Improvement Plan that the agency released in early December 2021 by co-hosting their third installment on 18 May 2022 from 12:30-1:30 PM ET.
The webinar will be co-hosted by the Food and Drug Administration and Stop Foodborne Illness, a non-profit public health organization.
This third webinar is called “Building a Coalition of Food Safety Culture Champions Across Your Organization” The speakers during the webinar will include:
- Charlean Gmunder, Chief Operating Officer at Blue Apron
- Dale Estep, Corporate Food Safety & Quality Assurance Manager at McKee Foods Corporation
- Ellison Beasley, R&D Food Safety Scientist at McKee Foods Corporation
The webinar series is entitled “Collaborating on Culture in the New Era of Smarter Food Safety.” It engages experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production.
The first two webinars in this series are available for listening by accessing the links below:
Session 1: Key Concepts in Addressing Food Safety Culture as a Science – Not a Slogan 11/4/21
Session 2: Making Leaders Risk Aware and Push to Reduce Risk 2/16/22
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