Like most federal regulations, the Foreign Supplier Verification Program (FSVP) includes many definitions, exemptions, and jargon. Essentially, the FDA wants companies importing food into the United States to make sure it’s up to the FDA’s standards. There’s a lot more to it than that. So we put together a list of tips to help companies better navigate this regulation and stay compliant.
Tip No. 1: Understand what food is exempt from the FSVP rule
There are some exemptions to the FSVP rule. Many of these exist because of the systems, statutes, and regulations that predate the rule. When determining your exemption status, it’s essential to evaluate each of these exemption categories’ additional details to determine eligibility. The USDA recommends thorough research but also provides a handy questionnaire to point companies in the right direction. FSVP exemptions include:
Juice, Fish, and Fishery Products – Subject to and in compliance with FDA’s applicable Hazard Analysis and Critical Control Point (HACCP) regulations.
Alcoholic Beverages – The Alcohol and Tobacco Tax and Trade Bureau (ATTB) regulates alcoholic beverages, including certain ingredients used in alcoholic beverages.
Food Research – Food imported for research or personal consumption.
Food Exports – Food imported for process and export.
Meat, Poultry, and Egg Products – Foods regulated by the U.S. Food & Drug Administration (USDA) at the time of importation.
Tip No. 2: Know which FSVP exemptions include modified requirements
Some exemptions to the FSVP rule include modified requirements that require considerable analysis to determine eligibility. These exemptions include:
Dietary Supplements (Finished vs. Bulk) – Dietary supplements are subject to most FSVP requirements. However, bulk/components are also subject to Part 111.
“Very Small” Supplier or Importer – Documented annual qualification requires less than $500,000 in annual food sales.
FDA-Approved Country – A list of approved countries with an equivalently robust food safety system, including Australia, New Zealand, and Canada.
Tip No. 3: Build a robust supplier verification program
Developing a comprehensive supplier verification program is crucial to FSMA compliance. Here are the five steps the FDA recommends:
Qualified Individual – You must identify a “qualified individual” who has the appropriate training, education, and experience to prepare your FSVP. Consultants are an option, but cultivating this knowledge in-house is optimal.
Hazard Analysis – Conduct a Hazard Analysis for each type of food your company imports. If not provided by a foreign supplier, it must be written and contain an evaluation of all environmental hazards.
Supplier Audit – Importers should conduct an onsite or remote audit of foreign suppliers or review a report conducted by a third party.
Verification Activities – Testing must include documentation regarding samples, test methods, corrective actions, lab information, and QI certification.
Periodic Assessment – A review of a foreign supplier’s food safety records must include the review date, general nature, conclusion, corrective action, and QI certification.
Recordkeeping – Required documentation and information must be easy to retrieve and in a format that doesn’t deteriorate over time. It’s essential to collect documents from foreign suppliers. Companies are also responsible for assessing them and documenting assessment activities.
Tip No. 4: Learn how hazards and controls are addressed
Under the FSVP rule, importers are responsible for determining known or reasonably foreseeable hazards likely to cause illness or injury for each type of food they import. These include biological hazards, chemical hazards, and physical hazards.
Verification programs must encompass both the identification of hazard types and the controls established to manage them. The hazard type dictates the appropriate verification activity.
For example, suppose an identified hazard can cause Serious Adverse Health Consequences or Death to Humans or Animals (SAHCODHA). In that case, your business will require onsite audits from the importer or an accredited third party. If the hazard has less severe consequences, you’ll likely need only periodic sampling and testing activities.
Tip No. 5: You must build a separate FSVP for each food and foreign supplier
You must create a separate FSVP for each foreign food and supplier, including when the same food comes from different suppliers. The FDA prefers integrated FSVP programs to reduce duplication of effort. Proper documentation throughout every step of the supply chain is essential to comply with the FSVP rule. The FDA primarily relies on the importer’s documentation to establish compliance with the FSVP rule and identify additional import and foreign inspections.
Simplifying FSVP Compliance
Navigating the ins and outs of FSMA’s Foreign Supplier Verification Program is a tremendous investment for any team. You can protect that investment with TraceGains Supplier Management. With TraceGains, you can streamline and automate supplier qualification and onboarding, verification, document management, and performance management, with everything tracked digitally for a complete audit trail.
Learn more about Supplier Management here.