The regulation on Foreign Supplier Verification Programs (FSVP) (21 CFR part 1, subpart L (sections 1.500-1.514)) applies to U.S. importers of food. However, importers may request information from their foreign suppliers or others to meet their FSVP requirements.
Standard FSVP requirements include, but are not limited to:
- conducting hazard analyses for imported food (section 1.504),
- evaluating the food and the foreign supplier (section 1.505),
- determining and performing supplier verification activities (section 1.506),
- taking corrective actions (when necessary) (section 1.508),
- ensuring importer identification at entry (section 1.509), and
- maintaining records (section 1.510).
In general, the importer will need to obtain assurances that its supplier is producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls requirements in 21 CFR part 117 or 507 or under the produce safety regulation (21 CFR part 112), as well as assurances that the food is not adulterated and not misbranded with respect to allergen labeling (section 1.502(a)).
The FSVP importer of a food might choose to rely on others to conduct certain FSVP activities, provided the importer reviews and assesses the results of these activities (see, e.g., sections 1.504(d), 1.505(d), 1.506(d)(3) and I(2)). For example, an importer may rely on a hazard analysis of a food conducted by the foreign supplier, and an importer might rely on the results of an independent third-party audit of the supplier that the supplier has requested.
Supplier verification activities must provide assurances that the hazards requiring a control in a food have been significantly minimized or prevented (section 1.506I). Depending on what verification activities the importer conducts, the importer might request information from the foreign supplier, such as results of audits or copies of relevant food safety records, so that it can meet its verification requirements.
