Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

The Food and Drug Administration (FDA) is adopting a regulation on #foreign_supplier verification programs (FSVPs) for importers of food for humans and animals. 

The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. 

We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA). The regulation will help ensure the safety of imported food.

• Executive Summary
• Purpose and Coverage of the Rule
• Summary of the Major Provisions of the Final Rule
• Modified Provisions for Certain Types of Importers
• Costs and Benefits
• I. Background
• A. FDA Food Safety Modernization Act
• B. Stages in the FSVP Rulemaking
• C. Summary of the Major Provisions of the Proposed Rule
• D. Public Comments
• II. Legal Authority
• III. Comments on the Proposed Rule and Supplemental Notice of Proposed Rulemaking
• A. Definitions (§ 1.500)
• 1. Definitions Generally
• 2. Audit
• 3. Environmental Pathogen
• 4. Farm
• 5. Farm Mixed-Type Facility
• 6. Food
• 7. Foreign Supplier
• 8. Good Compliance Standing With a Foreign Food Safety Authority
• 9. Harvesting
• 10. Hazard
• 11. Hazard Requiring a Control
• 12. Holding
• 13. Importer
• a. General
• b. U.S. Agent or Representative
• 14. Known or Reasonably Foreseeable Hazard
• 15. Lot
• 16. Manufacturing/Processing
• 17. Pathogen
• 18. Qualified Auditor
• 19. Qualified Individual
• 20. Ready-To-Eat Food
• 21. Receiving Facility
• 22. Very Small Foreign Supplier
• 23. Very Small Importer
• B. Applicability and Exemptions (§ 1.501)
• 1. Exemption for Certain Juice and Seafood Products
• 2. Exemption for Food Imported for Research or Evaluation
• 3. Exemption for Food Imported for Personal Consumption
• 4. Exemption for Alcoholic Beverages
• 5. Inapplicability to Food That Is Transshipped or Imported for Further Processing and Export
• 6. U.S. Goods Returned
• 7. Raw Agricultural Commodities
• 8. Produce Rarely Consumed Raw and Food Intended for Commercial Processing
• 9. Products Not for Use as Food
• 10. Food From Foreign Suppliers That Are Part of Same Corporate Structure
• 11. Other Requests for Exemption
• C. Purpose and Scope of FSVPs (§ 1.502)
• 1. Requirement To Develop and Follow an FSVP
• a. Meaning of “For Each Food”
• b. Role of Importer's Corporate Headquarters
• c. Entity Controlling the Hazards
• d. Adequate Assurances of Foreign Supplier's Adherence to Food Safety Standards
• e. Same Level of Public Health Protection
• f. Relevant Statutory Requirements
• g. U.S. International Obligations
• 2. Low-Acid Canned Foods
• 3. Importers in Compliance With Supply-Chain Program Provisions in the Preventive Controls Regulations
• 4. Importer Whose Customer Is in Compliance With the Preventive Controls Supply-Chain Program Requirements
• D. Personnel Developing and Performing FSVP Activities (§ 1.503)
• E. Hazard Analysis (§ 1.504)
• 1. General
• 2. Requirement To Conduct a Hazard Analysis
• 3. Hazard Identification
• a. General Types of Hazards
• b. Reasons for Presence of a Hazard
• 4. Hazard Evaluation
• a. Probability and Severity of Hazards
• b. Environmental Pathogens in Certain Ready-To-Eat Foods
• c. Hazard Evaluation Factors
• 5. Review of Another Entity's Hazard Analysis
• 6. Biological Hazards in RACs That Are Fruits or Vegetables
• 7. No Hazards Requiring a Control
• 8. Hazards Controlled by the Importer or Its Customer
• F. Evaluation for Foreign Supplier Approval and Verification (§ 1.505)
• 1. Evaluation for Approving Suppliers and Determining Verification Activities
• a. General
• b. Hazard Analysis
• c. Entity Applying Controls
• d. Foreign Supplier's Safety Procedures, Processes, and Practices
• e. Supplier's Compliance With Applicable FDA Food Safety Regulations
• f. Foreign Supplier's Food Safety History
• g. Other Factors as Appropriate and Necessary
• h. Guidance on Evaluating Food Risk and Foreign Supplier Performance
• 2. Approval of Foreign Suppliers
• 3. Reevaluation of Food Risks and Foreign Supplier Performance
• 4. Review of Evaluation or Reevaluation by Another Entity
• G. Foreign Supplier Verification Activities (§ 1.506)
• 1. Procedures To Ensure Use of Approved Suppliers
• a. Use of Approved Suppliers
• b. Temporary Use of Unapproved Suppliers
• c. Documentation of Use of Procedures To Ensure Use of Approved Suppliers
• 2. Written Procedures for Foreign Supplier Verification
• 3. Purpose of Supplier Verification
• 4. Foreign Supplier Verification Activities
• a. Verification Activity Requirements
• b. Need for Multiple Supplier Verification Activities
• c. Requirements for Food From Certain Farms, Facilities, and Egg Producers
• d. Substitution of Results of Certain Inspections for Onsite Auditing
• 5. Review of Results of Verification Activities
• 6. Documentation and Other Requirements for Supplier Verification Activities
• a. Onsite Auditing
• b. Sampling and Testing
• c. Review of Foreign Supplier Food Safety Records
• d. Other Appropriate Verification Activities
• 7. Independence of Qualified Individuals
• 8. Food Stored for an Extended Time Before Export
• H. Foods That Cannot Be Consumed Without Control of Hazards and Foods Whose Hazards Are Controlled After Importation (§ 1.507)
• 1. Food That Cannot Be Consumed Without Application of Controls
• 2. Control of Hazards by an Importer's Customer or Subsequent Entities in the Distribution Chain
• I. Corrective Actions and Investigations Into FSVP Adequacy (§ 1.508)
• 1. General Comments
• 2. Review of Complaints
• 3. Investigation
• 4. Corrective Actions
• 5. Investigations To Assess Adequacy of FSVP
• 6. No Limitation of Obligations
• J. Identification of Importer at Entry (§ 1.509)
• 1. Provision of Importer's DUNS Number
• 2. Designation of U.S. Agent or Representative
• 3. FDA List of Importers “Participating Under” the FSVP Regulation
• K. Records (§ 1.510)
• 1. Records Content and Format
• 2. General Requirements
• 3. Records Availability
• a. Records in English
• b. Place of Business or Reasonably Accessible Location
• c. Sending Records to FDA Electronically
• 4. Records Retention
• 5. Electronic Records
• 6. Public Disclosure
• 7. Relationship to Records Required Under Customs Regulations
• L. Dietary Supplements and Dietary Supplement Components (§ 1.511)
• 1. Dietary Supplements for Further Processing
• 2. Other Importers of Dietary Supplements
• a. Evaluation for Supplier Approval and Verification
• b. Corrective Actions
• c. Identification of Importer at Entry
• d. Recordkeeping
• e. Use of Approved Foreign Suppliers
• f. Determination of Appropriate Foreign Supplier Verification Activities
• g. Performance of Foreign Supplier Verification Activities
• h. Verification of Customers and Other Subsequent Entities
• 3. Mixed-Use Food/Drug Ingredients
• 4. Dietary Supplements Regulated in Foreign Countries as Drugs
• 5. Location of FSVP Regulations Applicable to Dietary Supplements
• M. Very Small Importers and Importers of Food From Certain Small Foreign Suppliers (§ 1.512)
• 1. Modified Requirements for Very Small Importers and Importers of Food From Certain Small Foreign Suppliers
• a. Comments Regarding the Proposed Modified Verification Requirements for Certain Farms
• b. Other Comments Related to the Appropriateness or Implementation of Modified Provisions for Small Entities
• 2. Provisions of the Modified Requirements for Very Small Importers and Importers of Food From Certain Small Suppliers
• a. Calculating Eligibility
• b. Written Assurances
• c. Corrective Actions
• d. Records
• 3. Other Concerns Regarding the Modified Requirements
• a. Withdrawal of Eligibility
• b. Identifying Very Small Importer Eligibility at the Time of Entry
• c. Compliance Period
• d. Outreach
• N. Importing a Food From a Foreign Supplier in a Country With an Officially Recognized or Equivalent Food Safety System (§ 1.513)
• 1. Appropriateness of the Modified Requirements
• 2. Systems Recognition Process
• 3. Commodity-Specific Arrangements With FDA
• O. Consequences of Failure To Comply With FSVP Requirements (§ 1.514)
• P. Other Issues
• 1. Implementation and Enforcement
• a. How should FDA conduct FSVP inspections?
• b. Role of States in Enforcement
• c. Decreased Border Sampling for Food Subject to FSVP
• 2. Outreach and Training
• IV. Effective and Compliance Dates
• A. Effective Date
• B. Compliance Dates
• V. Executive Order 13175
• VI. Economic Analysis of Impacts
• VII. Analysis of Environmental Impact
• VIII. Paperwork Reduction Act of 1995
• Reporting Burden
• A. Exemption for Food for Research or Evaluation
• B. Importer Identification at Entry
• Recordkeeping Burden
• A. Documentation of Production of LACF in Accordance With Part 113
• B. Hazard Analysis
• C. Evaluation for Supplier Approval and Verification
• D. Foreign Supplier Verification and Related Activities
• E. Requirements for Food That Cannot Be Consumed Without Hazards Being Controlled or for Which Hazards Are Controlled After Importation
• F. Investigations, Corrective Actions, and Investigations Into FSVP Adequacy
• G. Food Subject to Certain Dietary Supplement CGMP Requirements
• H. Food Imported by Very Small Importers and From Certain Small Foreign Suppliers
• I. Food Imported From a Country With an Officially Recognized or Equivalent Food Safety System
• IX. Federalism
• X. References
• List of Subjects
• PART 1—GENERAL ENFORCEMENT REGULATIONS
• Subpart L—Foreign Supplier Verification Programs for Food Importers
• Subpart L—Foreign Supplier Verification Programs for Food Importers
• PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
• PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

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