The Foreign Supplier Verification Program (FSVP) is a cornerstone of the FDA’s strategy to ensure imported foods meet U.S. safety standards. While the rule generally applies to most importers, the law also includes exemptions and modified requirements for certain categories of importers and foods, particularly small businesses.
1. Who Qualifies for Modified (or Reduced) FSVP Requirements?
A. Very Small Importers
Under FDA rules, a very small importer may use modified procedures rather than the full FSVP requirements. FDA defines very small importers as those with an average-annual sales of:
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less than $1 million in annual sales for human food and
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less than $2.5 million in annual sales for animal food
Annual sales are averaged over a three-year period. This average also includes the market value of human food that is manufactured, processed, packed, or held without sale. According to FDA’s Small Entity Compliance Guide, very small importers still have to establish an FSVP, but can follow modified procedures that reduce the scope of activities (see below).
B. Importers of Food from Certain Small Foreign Suppliers
Importers who source from small foreign suppliers may also be eligible for modified FSVP requirements. FDA identifies these small suppliers to include:
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Qualified facilities under preventive controls rules
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Farms exempt from produce safety requirements due to low sales (under 25K in annual sales)
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Small egg producers (fewer than 3,000 laying hens)
2. What Do Modified Requirements Look Like?
Modified procedures under FSVP are less burdensome than full verification programs.
For example, FDA’s compliance materials explain that:
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Very small importers may rely on written assurances from suppliers rather than full hazard analyses. These written assurances must be obtained prior to import and every 2 years thereafter.
- The written assurances must include information such as a brief description of preventative controls to control hazards and a statement that the foreign supplier is in compliance with their country’s laws.
According to FDA guidance, even importers following modified requirements must:
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Develop an FSVP for each food you import for each foreign supplier.
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Use a qualified individual to perform FSVP activities
- Take corrective actions as needed to ensure that imported food meets the same safety standards.
Small importers should focus on:
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Documenting supplier assurances: Written assurances from suppliers serve as primary verification when modified requirements apply.
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Minimal hazard analysis: Under modified procedures, a full written hazard analysis may not be required.
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Basic compliance recordkeeping: Records must still be maintained to demonstrate compliance.
6. Key Takeaways
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The FSVP rule requires importers to verify that food they import meets U.S. safety standards.
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Very small importers meeting the FDA definition can use modified FSVP procedures rather than full hazard analysis.
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Importers of food from certain small foreign suppliers may also qualify for modified requirements.
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Whether a small or large importer, the core emphasis remains on documentation, verification, and being able to show compliance when inspected.
This article is intended to provide a general overview of the modified requirements rule and should not be relied upon as a definitive determination of whether you qualify for modified requirements. For more information about the modified requirement rule, please contact us.
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