Standard FSVP vs Modified FSVP

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FSVP Plan

 

The main difference between Standard FSVP and Modified FSVP lies in the level of compliance requirements. The applicable scenario depends on the risk associated with the imported food, the type of supplier, and the nature of the importer’s business. Below is a detailed comparison:

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​​​​​​1. Standard FSVP (Full Compliance)

This applies to most food importers and requires the implementation of a comprehensive Foreign Supplier Verification Program (FSVP).

Key Requirements

• Hazard Analysis

  • Identify potential biological, chemical, or physical hazards in food.

  • Ensure the foreign supplier has appropriate preventive controls.

• Supplier Verification

  • Select an appropriate verification method based on food risk:

    • Document review (HACCP plan, testing reports)

    • On-site audits (inspection of supplier facilities)

    • Product testing

  • Ensure foreign suppliers comply with Current Good Manufacturing Practices (CGMP) and food safety regulations.

• Ongoing Supplier Monitoring

  • Periodically review the supplier’s food safety performance and re-verify when necessary.

• Recordkeeping

  • Importers must keep all FSVP records for at least 2 years for FDA review.

• Compliance with FDA Inspections

  • Importers may be subject to FDA inspections and must provide verification documents.

Who Must Follow Standard FSVP?

• General food importers.

• Importers of high-risk foods (e.g., fresh produce, seafood, dairy).

• Businesses that do not qualify for Modified FSVP.

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2. Modified FSVP (Reduced Compliance)

This applies to specific importers or food categories where compliance requirements are less stringent.

Eligibility for Modified FSVP

(1) Food Already Regulated by Another Agency

• If the food is already regulated by the USDA (e.g., meat, poultry, certain egg products), Modified FSVP applies.

• If the supplier complies with FDA’s Preventive Controls Rule, verification obligations may be reduced.

(2) Small Importers

• If the importer has less than $1 million in annual food sales (or $5 million for beverages), Modified FSVP applies.

(3) Foreign Suppliers Classified as a "Qualified Facility"

• If the supplier is a small business (less than $1 million in revenue), the importer only needs a written assurance from the supplier rather than full verification.

(4) US Food Processing Facilities Importing Ingredients

• If the imported food is only used as an ingredient in a US processing facility that complies with the Preventive Controls Rule, the importer’s verification responsibilities are reduced.

Key Requirements

• No Full Hazard Analysis Required

  • Importers may rely on the supplier’s compliance statements instead of conducting a full hazard analysis.

• Reduced Supplier Verification Requirements

  • May only require a written assurance from the supplier confirming compliance with FDA regulations.

• Simplified Recordkeeping

  • Importers must maintain compliance records but at a reduced level compared to Standard FSVP.

Who Qualifies for Modified FSVP?

• Importers of low-risk foods (e.g., certain processed foods).

• Small businesses.

• Importers of foods already regulated under other FDA/USDA programs.

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Conclusion

• Standard FSVP applies to most importers and requires full risk assessment, supplier verification, and ongoing monitoring.

• Modified FSVP applies to small importers, low-risk foods, or foods already regulated by other agencies, reducing compliance requirements while still maintaining FDA standards.

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FSVP Plan​