FSMA FSVP
- • Requires importers to share responsibility for ensuring safety of imported food
- • Risk-based (according to types of hazards, importers, and suppliers)
- • Flexibility in meeting requirements (assessing activities conducted by others)
- Risk-based (according to types of hazards, importers, and suppliers)
- • Alignment with supply-chain provisions of the Preventive Controls rules
Purpose of FSVPs
- • To provide adequate assurances that:
- – Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions
- – Food is not adulterated or misbranded (as to allergen labeling)
Who Must Comply?
- • “Importer” is U.S. owner or consignee of a food at time of U.S. entry
- • If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent
Who Is the Foreign Supplier?
- • The foreign supplier of a food is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.
Exemptions from FSVP
- • Firms subject to juice or seafood HACCP regulations
- • Food for research or evaluation
- • Food for personal consumption
- • Alcoholic beverages and ingredients (when importer uses them to make an alcoholic beverage)
- • Food transshipped through U.S.
- • Food imported for processing and export
- • “U.S. food returned”
- • Meat, poultry, and egg products subject to USDA regulation at time of importation
FSVP Compliance Dates
- Importers will be required to comply with FSVP no earlier than 18 months after issuance of final rule (i.e., May 30, 2017)
- If foreign supplier is subject to preventive controls or produce safety regulations, importer must comply with FSVP 6 months after supplier must comply with the relevant regulations
Oversight
- FDA will have oversight at all levels of the program, including:
- – Ability to revoke recognition granted by FDA to an accreditation body
- – Ability to withdraw an accreditation from a third- party certification body, even if it was granted by an FDA-recognized accreditation body
- –FDA does not need to wait for an accreditation body to act before taking action against a problematic certification body
