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FDA Working to Prepare Importers for Foreign Supplier Verification Program

Monday, August 15, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has provided additional information to help food importers prepare to comply with a rule requiring them to verify that their shipments meet U.S. safety standards. The foreign 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.

Importer Requirements. The FSVP importer is the U.S. owner or consignee of the food offered for import (i.e., 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.

Unless it is exempt or subject to modified requirements an FSVP importer may need to perform the following activities. However, FSVP importers can meet key obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as they review and assess corresponding documentation.

- use a qualified individual to develop an FSVP and perform FSVP activities

- perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each imported food or type of food (e.g., parasites, pesticide residues, natural toxins, food decomposition, food allergens, glass or other foreign materials)

 - evaluate risks posed by the food and the performance of the foreign supplier, considering the hazard analysis for the food, the entity that will be applying hazard controls (e.g., the foreign supplier or its ingredient supplier), the foreign supplier’s food safety practices and procedures, applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations (e.g., whether the supplier is the subject of an FDA warning letter or import alert), and the foreign supplier’s food safety performance history

- conduct appropriate supplier verification activities (e.g., annual onsite audits by a qualified auditor, sampling and testing, review of food safety records) to provide assurance that the hazards requiring a control have been significantly minimized or prevented

- take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate)

- reevaluate the food and foreign supplier every three years or sooner if the importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance

- identify the FSVP importer when filing for entry with U.S. Customs and Border Protection using the FSVP importer’s name, email address and unique facility identifier

Modified Requirements. Modified requirements under the FSVP rule would apply in the following circumstances.

- importation of foods that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation under specified circumstances

- importation of dietary supplements and dietary supplement components that will be subject to certain provisions of the dietary supplement current good manufacturing practice regulation, or other dietary supplements

- importation by a very small importer or an importer of foods from certain small foreign suppliers

- importation of certain food from a foreign supplier in good compliance standing with a food safety system that FDA has officially recognized as comparable or equivalent to that of the U.S.

Exemptions. The following foods and beverages are exempt from the FSVP rule.

- juice and seafood from foreign suppliers that are in compliance with the respective HACCP regulations and any ingredients that are intended to be used by the importer in the manufacturing and processing of finished juice and seafood products in accordance with the respective HACCP regulations

- small quantities of food imported for research and evaluation purposes that are not intended for retail sale and are not sold or distributed to the public

- small quantities of food imported for personal consumption that are not intended for retail sale and are not sold or distributed to the public

- food produced in compliance with FDA’s low acid canned food requirements

- certain alcoholic beverages

- food that is transshipped through the U.S. or that is imported for future export and not sold or distributed in the U.S.

- food that is manufactured/processed, raised or grown in the U.S., exported and returned to the U.S. without further manufacturing/processing

- certain meat, poultry and egg products

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

- FSVP importer whose foreign supplier is not subject to the preventive controls or produce safety rules: May 30, 2017

- FSVP importer whose foreign supplier is required to comply with the preventive controls rule for human food: May 30, 2017, but 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 importer of animal food whose foreign supplier is subject to the current good manufacturing practices requirements in the preventive controls rule for animal food: May 30, 2017, but 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 importer whose foreign supplier is required to comply with the animal food preventive controls requirements of the preventive controls rule for animal food but is not required to comply with the CGMP requirements: March 19, 2018, but 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 importer whose foreign supplier is required to comply with the produce safety rule, except for the requirements applicable to sprouts: July 26, 2018, but July 29, 2019, if the supplier is a small business and July 27, 2020, if the supplier is a very small business

- FSVP importer whose foreign supplier is required to comply with the requirements in the produce safety rule applicable to sprouts: July 26, 2017, but July 26, 2018, if the supplier is a small business and July 29, 2019, if the supplier is a very small business

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

- FSVP importer whose foreign supplier is a farm producing sprouts that is eligible for a qualified exemption under the produce safety rule: July 26, 2018, if the supplier is a small business and July 26, 2019, if the supplier is a very small business

The FDA notes that this list does not include importers that are themselves a manufacturer or processor subject to the supply-chain program provisions in the preventive controls rules, in which case the compliance date for FSVP 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.

For more information on the FSVP rule, please contact Shelly Garg at (305) 894-1043.

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