Importer Alert - For Many Food Importers, the Compliance Deadline for the FDA’s Foreign Supplier Verification Program is May 30, 2017
The Food Safety Modernization Act (“FSMA”), signed into law by President Obama in 2011, aims to ensure the safety of the U.S. food supply. For many Foreign Supplier Verification Program (“FSVP”) Importers, compliance with the FSVP begins May 30, 2017.
An FSVP Importer is a U.S. person who has a financial interest in the food product being imported, knowledge of food safety practices of the supplier, and control over the supply chain. It is not necessarily the importer-of-record listed on import documents, but rather, it is the U.S. owner or consignee of the imported food product.
If there is no U.S. owner or consignee at the time of entry, the foreign owner of the food product must appoint a U.S. agent, confirmed by such agent’s signed, written consent, to fulfill the owner’s responsibilities as FSVP Importer. Note that this is separate and distinct from an agent appointed for purposes of a foreign supplier’s FDA food facility registration.
Duties of FSVP Importers
Beginning on May 30, 2017, entry filers must enter into ACE the name, email address, and unique facility identifier (“UFI”) number for the FSVP Importer for each line entry of food product offered for importation into the United States. The FDA will recognize the FSVP Importer’s Dun & Bradstreet Data Universal Numbering System (“DUNS”) number as an acceptable UFI for FSVP purposes. A DUNS number can be obtained by visiting www.fdadunslookup.com.
In addition to this notification requirement, FSVP Importers must develop, maintain, and follow a written FSVP plan for each non-exempted food item they deal with, evaluate and approve foreign suppliers before sourcing from them, and take action as needed to address food safety concerns. The FSVP Importer must verify that the foreign supplier meets or exceeds U.S. food safety requirements, such as the Produce Safety Rule,1 the Preventive Controls for Human Food Rule,2 and the Preventive Controls for Animal Food Rule,3 and must verify that the foreign supplier is not producing food in a manner that will render it adulterated or misbranded with regard to allergen labeling.4
The FSVP Importer itself has the authority to determine appropriate verification measures based on a hazard5 analysis and risks associated with the food product and supplier performance; depending on the circumstances, supplier verification activities might include audits, records review, sampling and testing, or some combination of these (or other) activities. An FSVP Importer is permitted to rely on analyses, evaluations, and activities performed by other entities in certain circumstances, as long as it reviews and assesses underlying documentation.
If an FSVP Importer evaluates the known and reasonably foreseeable hazards in a food and determines there are no hazards requiring a control, there is no need to conduct a supplier evaluation or other verification activities. At the opposite extreme, if the FSVP Importer has reason to believe there is a reasonable possibility that a hazard in a food product will cause serious adverse health consequences or deaths, FSVP Importers must implement clear, rigorous verification standards, including, in most cases, an annual on-site audit of the supplier. Note that FSVP Importers are not responsible for FSVP preventive controls rules unless they are also facilities that manufacture, process, pack or hold food products. Note, also, that modified requirements may apply under the FSVP rule if the food item in question cannot be consumed without the hazards being controlled, or for which the hazards are controlled after importation under specified circumstances.
FSVP Importers should reevaluate the food product and foreign supplier every three years (or sooner, if they become aware of new information about hazards in the food product or the foreign supplier’s performance).
Mechanics of FSVP Compliance
When a food product under FDA oversight is offered for entry into the United States, the ACE system will prompt the filer to transmit one of the following codes
1. Entity role code “FSV,” which will indicate to the ACE system that the line entry is subject to the FSVP regulation
- This will trigger a request for the FSVP Importer’s name, email address and UFI (DUNS) number.6 If this information is not provided, the entry will be rejected.
2. One of two Affirmation of Compliance codes indicating that the article of food and importer are not subject to FSVP regulation at the time of entry. Enter:
- “FSX,” designating that the food product is exempt from the FSVP regulation or that compliance with the FSVP regulation is not yet required; OR
- “RNE,” designating that the food product is exempt from the FSVP regulation in accordance with 21 C.F.R. § 1.501(c) because it will be used for research or evaluation. Under this exemption, the food must be used for research or evaluation purposes and may not be sold or distributed to the public.
Some food products, such as raw fruits and vegetables, low-acid canned foods and dietary supplements, are subject to modified requirements. The following food products, however, are exempt from FSVP Regulation:
- meat, poultry and egg products subject to USDA regulations;
- suppliers covered by the seafood or juice Hazard Analysis and Critical Control Point (“HAACP”) regulations;
- raw materials or ingredients for use in a food produced under the seafood or juice HAACP regulations;
- alcoholic beverages;
- food imported for research or evaluation, provided it is not for retail sale, is properly labeled and is accompanied by an electronic declaration at entry;
- food transshipped through the US for export;
- food imported for processing and future export; and
- food imported for personal consumption.
Timeline for FSVP Compliance
FSVP Importers from the following supplier categories, who deal with the following foods, must comply with the May 30 deadline. Compliance dates for other categories of food (i.e. produce covered by the Produce Safety Rules) and suppliers (i.e. small businesses) will be later.
Processed Human Foods
Suppliers with 500 or more full time
Finished Dietary Supplements
Suppliers with 500 or more full time
Animal Food / Pet Treats
Suppliers with 500 or more full time
equivalent employees subject to CGMP requirements
Produce Not Covered Under the Produce Safety Rules
Note that FSVP Importers that are themselves manufacturers or processors subject to the supply-chain program provisions in the Preventive Controls for Animal Food Rule or the Produce Safety Rules are subject to different compliance dates.
1 “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”
2 “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”
3 “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.”
4 Note that FSVP Importers for food from Australia, Canada and New Zealand need only determine and document that the supplier is in compliance with that country’s food safety authority.
5 Potential hazards may be: biological (e.g. parasites and disease-causing bacteria); chemical (e.g. radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved additives, food allergens, nutrient deficiencies or toxicities (in animal food)); and/or physical (e.g. glass).
6 On a temporary basis, FSVP Importers who do not yet have a DUNS number may list “UNK” in the UFI field. If “UNK” is used, expect to be contacted by the FDA which will provide additional information regarding the UFI requirement, and offer guidance regarding the steps necessary to obtain a UFI.