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    March 9, 2023

    How FSMA 204 Impacts International Suppliers

    The Food Safety Modernization Act (FSMA) sets forth food safety regulations for the production, processing, packaging, and transportation of food intended for consumption within the United States. Additionally, Section 204 of FSMA, which was just published as a final rule in November 2022, sets additional guidance for food businesses on how they should establish enhanced traceability recordkeeping for foods considered “high risk” on the food supply chain.

    While drafted and enacted by United States Food and Drug Administration (FDA), the interconnectivity and decentralized nature of the global food supply chain will force both domestic and foreign importers and suppliers to consider how FSMA, and the FSMA 204 recordkeeping requirements, will impact their international operations.

    In most cases, businesses that are operating with facilities, foreign or domestic, that produce, process, pack, or hold food on the Food Traceability List (FTL) for human or animal consumption in the United States will be held to FSMA standards. Below, we break down key considerations for domestic importers and their foreign suppliers.

    Key Areas of FSMA Impacting International Suppliers

    While broad areas of the FSMA regulation apply to both domestic and international food companies, there are specific areas of the law that apply directly to foreign suppliers and/or domestic businesses contracting with foreign entities.

    Foreign Supplier Verification Program

    The Foreign Supplier Verification Program (FSVP) went into effect in 2017 and requires any U.S. business importing food to be held responsible for the safety standards of their foreign supplier. Specifically, the U.S. business is responsible for developing, implementing, and recording a written plan for verifying that their foreign suppliers meet applicable safety and quality standards.

    Mainly, FSVP requires importers (those receiving the food) to:

    • Determine known or reasonably foreseeable food hazards along their supply chain through onsite audits, sample testing, and other relevant measures.
    • Evaluate risks using both hazard analysis and a foreign supplier’s performance.
    • Conduct supplier verification in accordance with FSVP guidelines.
    • Take corrective measures as necessary to maintain food safety.
    • Maintain safety records from suppliers.

    Most importantly, the business receiving the food must develop and follow FSVP protocols for each food product brought into the country. If importers have multiple suppliers for a food product, they must maintain FSVP protocols for each and every one.

    For importers, the FDA has also instituted a voluntary fee-based program intended to provide enhanced review and entry for participating importers. This program, the Voluntary Qualified Importer Program (VQIP), allows importers to expedite their food products into the U.S.

    FSMA Safety, Quality, and Hazard Compliance

    Though no shock to international businesses that have worked with the FDA previously, many foreign suppliers may be surprised at the level of compliance they must adhere to when importing food into the United States under FSMA. As with domestic suppliers, FSMA requires international companies to comply with stringent regulations that prioritize a preventive approach over the reactive approach that food companies have historically taken.

    FSMA regulations are comprised of seven major rules, of which the Foreign Supplier Verification Program is one. The other 6 areas will also be required by international food companies planning to produce, process, pack, or hold food on the FTL for human or animal consumption in the United States and they include:

    • Preventive Controls for Human Food
    • Preventive Controls for Animal Food
    • Product Safety
    • Third-Party Certification
    • Food Defense
    • Sanitary Transportation

    FSMA 204 Recordkeeping Requirements for International Businesses

    The most recent development for international business is the finalization of FSMA Section 204. FSMA 204 puts into motion enhanced traceability recordkeeping requirements that all businesses (foreign and domestic) that handle foods on the FTL intended for U.S. consumers will need to adhere to by January 20, 2026. To help international businesses understand this new ruling, the FDA released five translations on the finalized FSMA 204 regulations webpage: Spanish, Bahasa Indonesian, Simplified Chinese, Thai, and Vietnamese.

    Specifically, businesses will need to do the following to maintain compliance after the 2026 deadline:

    • Review the Food Traceability List and identify which foods will require additional traceability records. Keep in mind, foods can be both whole or used as an ingredient in a recipe (example: ready-to-eat deli salads, peanut butter sandwich cookies, etc.).
    • Build, record, and maintain a traceability plan, which includes how foods are identified, how traceability lot codes are assigned, farm maps, and other information that can help the FDA narrow their search for potentially contaminated foods.
    • Maintain and protect traceability records for up to 24 months (2 years) and provide records within a 24-hour time period once the FDA makes a request.
    • Utilize standardized terms outlined in FSMA 204 to maintain clarity across the supply chain, including critical tracking event terms, key data elements, and more. While international companies may use a different language to maintain their records, the FDA does require companies to turn over any additional materials that may help them interpret records, including English translations, if needed, upon FDA requests.

    FSMA Exemptions for FSVP

    FSVP includes a broad swath of businesses operating internationally and importing into the United States, but certain exclusions do apply. There are also certain imported foods not covered by the FSVP, including personal consumption, transshipped foods, and the following:

    • Fish and fishery products
    • Juice or certain ingredients for use in juice products
    • Food for research or evaluation
    • Certain alcoholic beverages or certain ingredients for use in alcoholic beverages
    • Certain meat, poultry, and egg products under USDA regulation

    FSMA 204’s recordkeeping requirements does have some exemptions as well, and international businesses can use the FDA’s exemptions tool to determine if they qualify. However, international businesses should note that the creation of FSMA 204, and FSMA as a whole, replicate similar steps that other countries are taking as these countries prioritize consumer safety across the global food supply chain.

    How to Integrate International Suppliers into your FSMA Strategy

    Depending on your reliance on foreign suppliers, the FSVP rule can have a wide range of potential impacts to your business. Instituting the appropriate internal controls for meeting FSVP mandates will require businesses to maintain robust documentation and enable seamless collaboration and communication with suppliers.

    Trustwell’s FoodLogiQ platform offers a suite of solutions to help digitize organizational capabilities, manage complex supplier networks, trace back and forth across your supply chain, and improve operational excellence while creating a more seamless approach to meeting FSMA and FSVP compliance. With centralized documentation and communication, businesses are able to manage their foreign supplier base, communicate requirements, and track compliance seamlessly within one platform.

    Contact us today to learn more about how Trustwell solutions can help your business navigate regulatory compliance.

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