FDA Final Rule on Foreign Supplier Verification Program (FSVP)
December 1, 2015
On November 27, 2015, the Food and Drug Administration (FDA) released a final rule on the Foreign Supplier Verification Programs (FSVP), adopts provisions concerning FSVPs that importers must create and follow to help ensure the safety of imported food. The FSVP rule is part of FDA's implementation of the FDA Food Safety Modernization Act (FSMA).
What is the FSVP rule? The FSVP rule requires that importers perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that meets applicable U.S. safety standards. It now requires importers to: 1) verify that their foreign supplies are producing food in a manner that provides the same level of public health protection as the preventive controls; or 2) produce safety regulations to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling
Who constitutes an importer for purposes of the FSVP? An importer is the U.S. owner or consignee of a food offered for import into the United States. Very small importers and importers of certain small foreign suppliers are now subject to the modified FSVP requirements.
FDA’s definition of a very small importer and small foreign suppliers under the FSVP rule: Under the FSVP rule, a very small importer is an importer with a sales ceiling of $1 million for human food and $2.5 million for animal food. Small foreign suppliers include: 1) Farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption; and 2) Shell egg producers with fewer than 3,000 laying hens.
What if there is no U.S. owner or consignee: If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.
Requirements for importers under the FSVP rule:
Hazard identification and evaluation: Importers are now required to identify and evaluate the known or reasonably foreseeable hazards associated with each type of food they import. Hazards defined by FDA include: a) biological hazards (e.g. parasites and disease-causing bacteria); b) chemical hazards (e.g. radiological hazards, pesticide and drug residues, food decomposition, unapproved food or color additives, and food allergens); and/or c) physical hazards (e.g. glass). The importer’s evaluation must assess the probability of these hazards and the severity of the illness or injury that could potentially occur as result of these hazards. In conducting hazard identification and evaluations, some factors that FDA advises importers to consider include: 1) the raw materials and other ingredients; 2) harvesting, raising, manufacturing, processing and packing procedures; 3) Packaging and labeling activities; 4) Storage and distribution; 5) Transportation practices; and 6) Sanitation, including employee hygiene. An importer can rely on another entity to conduct the hazard analysis, so long as the importer reviews and assesses the relevant documentation.
Evaluation of Food Risk and Supplier Performance: Importers must conduct an evaluation to determine the risk posed by the imported food and a foreign supplier’s performance. An importer’s evaluation must include, but is not limited to, a review of the foreign supplier’s procedures, processes and practices related to the safety of food, applicable FDA food safety regulations, information regarding the foreign supplier’s compliance, and the foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems. The importer can rely on another entity (other than the foreign supplier) to perform the evaluation of risk, so long as the importer reviews and assesses the relevant documentation.
Supplier Verification: After conducting a hazard identification and evaluation, the importer must then establish and implement written procedures to import from only approved foreign suppliers and the importer must conduct appropriate supplier verification activities. Appropriate supplier verification activities may include annual on-site audits of the supplier’s facility, sampling and testing, or a review of the supplier’s relevant food safety records. An importer can rely on another entity (other than the foreign supplier) to determine and perform appropriate supplier verification activities, so long as the importer reviews and assesses the relevant documentation.
Corrective Actions: The FSVP rules require that importers promptly take appropriate corrective actions if the importer determines: 1) that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required under the produce safety and preventive controls regulations, as applicable; or 2) that the supplier produces food that is adulterated or misbranded with respect to allergen labeling. The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.
Record retention requirements of FSVP activities: Records of an importer related to a foreign supplier verification program must be maintained for a period of not less than two (2) years and must be made available promptly to a duly authorized representative of the Secretary of the Department of Health and Human Services (the Secretary) upon request.
Categories of imported food that are not covered by FSVP: The following categories of imported food not covered by FSVP are the following: 1) Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations; 2) Food for research or evaluation; 3) Food for personal consumption; 4) Alcoholic beverages and certain ingredients for use in alcoholic beverages; 5) Food that is imported for processing and future export; 6) Low-acid canned foods (LACF), such as canned vegetables; and 6) Certain meat, poultry and egg products regulated by the USDA at the time of importation.
When must importers comply with the FSVP rules? Importers subject to the FSVP rules must comply by May, 2017, eighteen (18) months from the November 27, 2015 publication date. It is important to note that the eighteen (18) month compliance requirement does not apply to importers importing food from a supplier that is subject to the preventive controls or produce safety rules and does not apply to an importer that itself a manufacturer or processor subject to the supply-chain program provisions.
For further information on the FSVP rule and to ensure you are in compliance, please contact Davidson Law Group, P.A.