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Foreign Food Supplier Verification Program Requirement Fast Approaching

Thursday, May 11, 2017
Sandler, Travis & Rosenberg Trade Report

A Food and Drug Administration rule requiring food importers to verify that their shipments meet U.S. safety standards will start taking effect May 30. Noncompliant importers risk supply chain disruptions, delays in entry processing, and possibly the exclusion of their products from the U.S. marketplace.

The FDA’s food supplier verification program rule requires importers of food for humans or animals, with some exceptions, to verify that (a) their foreign suppliers use processes and procedures that provide the same level of public health protection as the U.S. preventive controls and produce safety regulations, where applicable; and (b) the food they import is not adulterated and not misbranded with respect to food allergen labeling.

The FSVP importer is not the same as the importer of record as defined by U.S. Customs and Border Protection but is the U.S. owner or consignee of the food offered for import; i.e., the entity who owns the food, has purchased it, or has agreed in writing to purchase it. If there is no U.S. owner or consignee at the time of entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent.

FSVP importers may need to perform a number of activities, although they may rely on analyses, evaluations, and activities performed by other entities in certain circumstances. These activities  include developing FSVPs, conducting hazard analyses for each imported food or type of food, evaluating risks, verifying that suppliers have significantly minimized or prevented hazards, and reevaluating foods and foreign suppliers at least every three years. The rule includes modified requirements for various circumstances (e.g., small importers and foreign suppliers) and exemptions for specific foods and beverages.

A qualified individual should perform required FSVP activities, said Domenic Veneziano, independent FDA regulatory and strategic consultant for Sandler, Travis & Rosenberg and previously the FDA’s director of import operations. “The individual creating the FSVP must have the education, training and/or experience necessary to conduct a sophisticated review of all the records associated with an activity under review,” Veneziano emphasized. “It’s a major undertaking and requires a high level of expertise.”

The dates by which FSVP importers must comply with the FSVP rule differ based on a number of considerations, including the nature of the importer, the size of the foreign supplier, and whether the supplier must meet the requirements of the FDA’s final rules on preventive controls for human or animal food or produce safety.

- FSVP importers whose foreign suppliers are not subject to the preventive controls or produce safety rules must comply by May 30, 2017

- FSVP importers whose foreign suppliers are (a) required to comply with the preventive controls rule for human food or (b) subject to the current good manufacturing practices requirements in the preventive controls rule for animal food must comply by May 30, 2017, but have until March 19, 2018, if the supplier is a small business and March 18, 2019, if the supplier is a qualified facility, including a very small business

- FSVP importers whose foreign suppliers are required to comply with the animal food preventive controls requirements of the preventive controls rule for animal food but are not required to comply with the CGMP requirements must comply by March 19, 2018, but have until March 18, 2019, if the supplier is a small business and March 17, 2020, if the supplier is a qualified facility, including a very small business

- FSVP importers whose foreign suppliers are required to comply with the produce safety rule, except for the requirements applicable to sprouts, must comply by July 26, 2018, but have until July 29, 2019, if the supplier is a small business and July 27, 2020, if the supplier is a very small business

- FSVP importers whose foreign suppliers are required to comply with the requirements in the produce safety rule applicable to sprouts must comply by July 26, 2017, but have until July 26, 2018, if the supplier is a small business and July 29, 2019, if the supplier is a very small business

- FSVP importers whose foreign suppliers are subject to the produce safety rule and eligible for a qualified exemption (other than a farm producing sprouts) must comply by July 29, 2019, if the supplier is a small business and July 27, 2020, if the supplier is a very small business

- FSVP importers whose foreign suppliers are farms producing sprouts that are eligible for a qualified exemption under the produce safety rule must comply by July 26, 2018, if the supplier is a small business and July 26, 2019, if the supplier is a very small business

For importers that are themselves a manufacturer or processor subject to the supply chain program provisions in the preventive controls rules, the compliance date is the later of the applicable date in the above list or the date by which the importer is required to comply with the supply chain program provisions.

To learn more about the FSVP rule and how to comply, contact Domenic Veneziano at DVeneziano@strtrade.com.

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