We know what you’re thinking, “Does FSMA’s Foreign Supplier Verification Program (FSVP) apply to me?” Though this is an easy question to ask, the correct answer may be more challenging to obtain. Incoming shipments of goods to the United States can change hands numerous times, so how do you define the right importer per this rule?
Since the importer is the responsible party under FSMA’s FSVP rule, the appropriate first step in the process is to determine which party will be the importer. Is it the party who purchased the food, the owner, or the consignee? When in doubt, look for the party that holds the controlling financial interest. Often, this is the party interacting with a foreign supplier: The consignee, the owner, or the U.S. agent.
A Few Exemptions
As is often the case, there are some exemptions to the FSVP rule. Many of these exemptions exist because of existing systems, statutes, or other regulations that are in place. These 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.
When determining your exemption status, it’s essential to evaluate each of these exemption categories’ additional details to determine your eligibility. The USDA recommends thorough research but also provides a handy questionnaire to point companies in the right direction.
In addition to the exemptions listed above, some exemptions include modified requirements that require considerable analysis to determine eligibility. These exemptions include:
Dietary Supplements (Finished vs. Bulk) – Finished 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.
Contents of a Verification Program
FSMA is a two-tiered system designed to enable both prevention and verification. Each rule establishes safety standards in both categories and relies on the industry for verification of compliance. No longer will food manufacturers rely upon the FDA to enforce these standards. FSVP requires the importer to verify (either upstream or downstream) suppliers are meeting the appropriate safety standards. This directive promotes deeper integration between suppliers and encourages higher levels of transparency throughout the global food supply chain. It also modifies the definition of a “qualified supplier,” as standards for quality and cost are now being replaced by compliance and customer service.
A Robust Verification Program
Developing a comprehensive verification program is a serious effort for any organization. It must be prepared by a “qualified individual” who possesses the appropriate education, training, and experience. Consultants are an option, but many companies benefit from sending an employee to the two-day training, and cultivating this knowledge in-house, is worth the cost. Here are the essential steps recommended by the FDA to develop a Foreign Supplier Verification Program:
Hazard Analysis – Conduct a 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.
Onsite Audit – Importers have the right to conduct an onsite audit of a foreign supplier or review a report conducted by a 3rd 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 – Records must be quickly retrievable and available in a format that won’t deteriorate over time. It is essential to collect documents from foreign suppliers. Companies are also responsible for assessing them and document the assessment activities.
Control and Type of Hazard
Verification programs must encompass both the hazard type and control. The hazard type will define the appropriate verification activity. If a hazard is identified as a Serious Adverse Health Consequences or Death to Humans or Animals (SAHCODHA) hazard, you’ll require onsite audits from the importer or an accredited 3rd party. Otherwise, you’ll likely resort to periodic sampling and testing activities.
Navigating the ins and outs of FSMA’s Foreign Supplier Verification Program is a tremendous investment for any organization. Protect that investment with TraceGains Supplier Management. Streamline supplier qualification and sourcing, automate scorecarding, collect and digitize supplier documents, extract data from those documents, and organize it into supplier performance dashboards and reports.
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