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Compliance Dates Approaching for FDA’s Foreign Supplier Verification Program

Friday, January 25, 2019
Sandler, Travis & Rosenberg Trade Report

Importers of food for humans or animals face several upcoming compliance dates under the Food and Drug Administration’s foreign supplier verification program. Sandler, Travis & Rosenberg is conducting a webinar Jan. 29 on how importers can prepare for and manage FDA inspections under this program – click here for more information or to register.

Under the FSVP, food importers are generally required 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 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 (click here for more information) 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

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. Many compliance dates have already passed; those remaining are as follows.

- FSVP importer whose foreign supplier is required to comply with the preventive controls rule for human food: 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: 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 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 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 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, 2019, if the supplier is a very small business

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

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