Frequently Asked Questions

This is a new term in the final rule. A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review.

The Hazard Analysis and Critical Control Points systems that many FDA-regulated manufacturers have in place are the foundation of the preventive controls regulations. Although there are similarities between the FSMA preventive controls requirements and the HACCP system, not every provision is identical. For example, in HACCP systems, controls are applied at critical control points (CCPs), whereas preventive controls include controls at CCPs or controls other than those at CCPs that are appropriate for food safe.

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,
• evaluating the food and the foreign supplier,
• determining and performing supplier verification activities,
• taking corrective actions (when necessary),
• ensuring importer identification at entry, and
• maintaining records.

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)).

For the purposes of FSVP, the definition of the term “importer” is the “U.S. owner or consignee” of an article of food offered for import into the U.S. This is the person in the United States who, at the time of entry of an article of food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.