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FDA releases final foreign supplier rule

The US Food and Drug Administration (FDA) has released its final rule for Foreign Supplier Verification Programs (FSVP) for Food for Humans and Animals. This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA). Most importers will be required to comply with FDA’s FSVP rule in May 2017 (18 months after publication).

FDA defines an FSVP as a program that verifies “that (importers’) foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.” The FSVP rule covers importers of food and beverages, which FDA defines as “the US owner or consignee of a food offered for import into the United States.” If there is no US owner or consignee, the exporter’s US agent is the importer.

Importers must create an FSVP for each food imported from each foreign supplier. If they import the same food from two different suppliers, that will require two FSVPs. One element of an FSVP is a hazard analysis. Importers must determine potential biological, chemical, and physical hazards posed by each food they import.

Importers must also evaluate the performance of each of their foreign suppliers and use that evaluation to approve suppliers. This includes evaluating each supplier’s history of compliance with FDA food safety regulations, “including whether the foreign supplier is the subject of an FDA warning letter or import alert.” Importers should only import from approved foreign suppliers.

For approved foreign suppliers, importers must determine appropriate supplier verification activities, conduct those activities, and conduct corrective actions. Examples of verification activities may include annual on-site audits of a supplier’s facility, sampling and testing, and review of a supplier’s food safety records. Importers should choose verification activities that appropriately fit the risks of each supplier.

Importers may designate a third party to conduct a hazard analysis, a supplier risk evaluation, or to perform verification activities on their behalf. Registrar Corp’s food safety specialists can develop or review a food safety plan that identifies potential hazards associated with a food or supplier and a plan to control those hazards. Registrar Corp also offers an FDA Compliance Monitor, which food facilities may use to monitor their foreign suppliers for FDA inspections, warning letters, import alerts and import refusals. The monitor is updated consistently, allowing importers to take prompt corrective action.

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