Frequent FSVP-Related Questions

AFI Staff Report

As the U.S. food import industry’s trade association, AFI staff members frequently field questions about the Foreign Supplier Verification Programs regulation. We’re highlighting some of the most frequently asked questions, taking the answers directly from FDA’s draft guidance document on FSVP – though we’ve taken the liberty of taking out some of the government-speak.

Q: How do I determine if I am an importer of a food for the purposes of the FSVP regulation (FSVP importer)?

A: You are the FSVP importer if you are the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.

Q. Must the FSVP importer be in the United States?

A: The FSVP importer must be located in the United States. This applies whether you are the U.S. owner or consignee of the food at the time of entry or the U.S. agent or representative of the foreign owner or consignee at the time of entry. An FSVP importer could be a person who resides in the United States or maintains a place of business in the United States. It would not be sufficient to merely have a mailbox, answering service or some other place in the United States where the importer is not physically present.

Q: What if multiple entities meet the definition of “importer” for a particular food?

A: In some cases there might be multiple entities that meet the “importer” definition for the same line of an entry of food offered for import into the United States. For example, a U.S. company might purchase olive oil manufactured in Italy and, at the time of entry, have entered into an agreement to re-sell the olive oil to a U.S. retail store after the product has entered the United States. In this case, both the U.S. purchaser and the retail store might meet the definition of importer. Alternatively, a foreign grower of lettuce might arrange for the importation of the lettuce into the United States under written agreements to sell the lettuce to multiple unaffiliated U.S. buyers once the lettuce has entered this country. When there are multiple entities that meet the “importer” definition, these entities will need to determine who will be responsible for meeting the FSVP requirements.

Q: Is the importer, as defined in the FSVP regulation, the same person as the importer of record recognized by CBP for import entry?

A: The importer of a food for purposes of FSVP may be but is not necessarily the importer of record for CBP purposes. Under the FSVP regulation, the importer is the person who is responsible for verifying that the imported food was produced in accordance with applicable U.S. food safety requirements. In contrast the CBP importer of record of a food might be an express consignment operator with little to no knowledge of the safety regulations applicable to the products for which they obtain clearance from CBP.

Q: Is the U.S. agent or repre­sentative for FSVP purposes the same as the U.S. agent for purposes of registration of a foreign food facility?

A: A U.S. agent or representative of a foreign owner or consignee for FSVP could be but is not required to be the same person as the U.S. agent of a foreign food facility named in the facility’s FDA registration. FDA’s regulation implementing the food facility requirements requires that the registration for foreign facilities include the name of the U.S. agent for the facility; the U.S. agent acts as a communications link between FDA and the foreign facility for both emergency and routine communications.

In contrast, the U.S. agent or representative of a foreign owner or consignee for FSVP purposes is responsible for meeting the full breadth of applicable requirements under the FSVP regulation. These requirements include conducting a hazard analysis, performing supplier verification activities and taking other steps to ensure the safety of imported food. These responsibilities are qualitatively different from serving as a communications link with a foreign facility. Therefore, a U.S. agent or representative for FSVP purposes serves a different role than a U.S. agent named in the FDA registration of a foreign food facility.

*Please note that AFI serves as the facility registration agent for hundreds of facilities but does not serve as an FSVP agent.

Q: Under what circumstances are importers of juice and fish and fishery products and ingredients for such products exempt from the FSVP regulation?

A: The FSVP regulation does not apply to juice and fish and fishery products you import from a foreign supplier that is required to comply with and is in compliance with FDA’s hazard analysis and critical control point regulations for those foods. Instead, you must comply with the importer requirements of the juice and fish and fishery products regulations. In addition, the FSVP regulation does not apply with respect to raw materials or other ingredients you use in manufacturing or processing juice subject to part 120 or fish and fishery products subject to part 123, provided that you comply with the relevant regulation when manufacturing or processing the juice or seafood product from the imported raw materials or other ingredients.

Q: Does the exemption for food for research or evaluation include food imported for consumption or distribution at trade shows?

A: Generally, no. Because food imported for consumption at trade shows typically is sold or distributed to the public generally (i.e., anyone who attends the trade show), exempting such food from the FSVP regulation would be inconsistent with the exemption provisions for food imported for research or evaluation.

Q: What does it mean to have an FSVP for “each food?”

A: You must establish an FSVP for each food you import from each of your foreign suppliers. You do not need to establish a separate FSVP for different versions of the same food from a single foreign supplier when the differences in the foods do not result in different hazards requiring a control. For example, it might be appropriate for you to develop a single FSVP covering several different packaging sizes or formats for a particular food from a supplier, provided that the packaging differences do not pose different hazards that need to be controlled by the foreign supplier and addressed through different supplier verification activities. Similarly, you might include different flavor varieties of the same food in a single FSVP provided that the hazards and corresponding controls are the same. Examples of “foods” that you might address in a single FSVP (assuming any hazards requiring a control in the different versions of the food are the same) include different varieties of yogurt, cookies, potato chips, chocolate candies, or extruded dog or cat food.

However, if the use of different ingredients to make what is essentially the same food could result in different hazards requiring a control or a need for different types of controls, you should either establish separate FSVPs for these foods or create a single FSVP for the foods that separately addresses the differing hazards or controls required.

Your FSVPs must be specific to each foreign supplier of a food. Thus, if you obtain a food from multiple foreign suppliers, you must have a separate FSVP for each supplier. This is appropriate because the FSVP regulation requires you to consider not just hazards inherent in the food you import but also your foreign suppliers’ processes and procedures as well as their compliance and performance history.

Q: How should I design my FSVP to provide assurances that a human food from a foreign supplier is not misbranded with respect to labeling for the presence of major food allergens?

A: As part of your FSVP, you should review the label of each human food you import to determine that it complies with the labeling requirements for major food allergens. Major food allergen means any of the following: milk, egg, fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. *Note: The U.S. will consider sesame an allergen as of Jan. 1, 2023.

Q: Who must develop and perform activities required for my FSVP?

A: A qualified individual as defined in 21 CFR 1.500 must develop your FSVP and perform each of the activities required under the FSVP regulation.

Q: Who is a qualified individual?

A: A qualified individual is a person who has the education, training or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation and can read and understand the language of any records that the person must review in performing this activity.

A qualified individual may be but is not required to be an employee of the importer; you might also rely on non-employees such as a consultant or a third-party auditor. A government employee, including a foreign government employee, may be a qualified individual.

Q: What is the purpose of the hazard analysis?

A: The purpose of your hazard analysis is to determine the food safety concerns that might be posed by a food you import into the United States. For each type of food you import, you must conduct a hazard analysis to identify potential food safety hazards that must be managed through controls. You must also assess the probability that the hazard you identify will occur in the absence of controls and assess the severity of the illness or injury to humans or animals from the hazard if the hazard were to occur.

Q: What basic requirements apply to a hazard analysis?

A: A hazard analysis must identify and evaluate, based on experience, illness data, scientific reports and other information, the known or reasonably foreseeable hazards in each food you import to determine whether there are any hazards that require measures to control the hazard (e.g., a heat step that is lethal to a pathogen; sorting to remove physical hazards). A hazard analysis must be written, even if you determine that there are no hazards that require a control. A qualified individual must conduct the hazard analysis.

Q: What types of hazards should I consider in the hazard analysis?

A: Your hazard analysis must consider known or reasonably foreseeable hazards in each food you import. Such hazards include: • Biological hazards, including microbiological hazards such as parasites, viruses, environmental pathogens and other pathogens; • Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, food allergens and, in animal food, nutrient deficiencies or toxicities; and • Physical hazards, including stones, glass and metal fragments.

Q: May I rely on a hazard analysis conducted by another entity?

A: Yes. You may rely on a hazard analysis conducted by another entity provided it was conducted by a qualified individual. Your foreign supplier who has conducted a hazard analysis under the preventive controls regulation is likely to be a good source for a hazard analysis for the food you import from them. Alternatively, you might rely on a hazard analysis of a food conducted by another entity, such as a consolidator of a RAC or a trade association that conducted a hazard analysis on behalf of its members. If you rely on a hazard analysis conducted by another entity, you must review and assess that hazard analysis and document your review and assessment, including documenting that the hazard analysis was conducted by a qualified individual.

Q: How must I approve a foreign supplier?

A: You must approve a foreign supplier on the basis of your evaluation of the hazards in the food and the foreign supplier’s performance, including its food safety procedures, processes and practices, its record of compliance with FDA food safety regulations and its food safety history. Before approving a foreign supplier, you should have reasonable assurance, based on your consideration of the supplier’s performance, that the supplier is controlling the hazards in the food you import or verifying that the hazards have been controlled by its ingredient suppliers. You must document your approval of each foreign supplier. You could do so by maintaining a paper list of approved suppliers or an electronic system that can generate a list of approved suppliers as needed.

Q: What foreign supplier verification activities may be appropriate?

A: Depending on the evaluation of the food and foreign supplier, you may conduct foreign supplier verification activities from among the following: • Onsite audits; • Sampling and testing of a food; • Review of the foreign supplier’s relevant food safety records; and • Other appropriate supplier verification activities.

Q: Should I conduct more than one supplier verification activity for a particular food from a particular foreign supplier?

A: In some cases, you may determine that more than one supplier verification activity is warranted for a particular food from a particular foreign supplier. For example, when the identified hazard requiring a control in a food is a pesticide that is not a SAHCODHA hazard, you may determine that the appropriate foreign supplier verification activities are to review the foreign supplier’s food safety plan and to sample and test some of the shipments you import for pesticides. *Note: Many importers were using more than one verification step prior to FSVP and continue to do so.

Q: What foreign supplier verification activities must I conduct?

A: Based on the determination you made (or reviewed and assessed), you must conduct (and document) or obtain documentation of one or more supplier verification activities (onsite auditing, sampling and testing, review of foreign supplier food safety records or some other mechanism determined to be appropriate) for each foreign supplier before importing the food and periodically thereafter.

Q: What documentation of sampling and testing must I have?

A: You must retain documentation of each sampling and testing of the food. Your documentation must include: • Identification of the food tested (including lot number, as appropriate), • The number of samples tested, • The test(s) conducted, including the analytical method(s) used, • The date(s) on which the test(s) were conducted, • The date of the report of the testing, • Results of the testing, • Corrective actions taken in response to detection of hazards, • Information identifying the laboratory that conducted the testing (e.g., name and address), and • Documentation that the testing was conducted by a qualified individual. If any of this information is included in the laboratory report or COA you receive from the laboratory that performs the test, you may use the report or certificate as documentation of that information (i.e., you need not create a duplicate record of the information on the laboratory report).

Q: What are the general requirements for maintaining FSVP records?

A: You must keep records as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche or other accurate reproductions of the original records) or electronic records to support your FSVP for each food from a particular foreign supplier. You must sign and date your FSVP records upon initial completion and upon any modification. For example, when you complete a hazard analysis, you must sign and date the analysis. If you modify the hazard analysis based on a reevaluation, you must sign and date the modified hazard analysis. Additional examples of FSVP records that must be signed and dated upon initial completion and any modification are records documenting the approval of foreign suppliers, determination of appropriate foreign supplier verification activities and performance of supplier verification activities.

Q: Will every violation of the FSVP regulation warrant an enforcement action by FDA?

A: No. FDA will employ a risk-based enforcement strategy focusing on violations that pose a risk to public health. We will consider your overall compliance with the FSVP regulation and any corrective actions you have taken or plan to take in determining whether a violation of FSVP requirements warrants FDA taking enforcement action.

Q: How will FDA inform me if I am not in compliance with the FSVP requirements when FDA reviews my records?

A: If the FDA investigator observes potential violations of the FSVP requirements during a review of your records, the investigator will provide you with a written summary of the observations on an FDA Form 483a (“FSVP Observations”). FDA may also discuss the observations with you. In a discussion of the observations, you may inform the investigator or other agency personnel of corrections you have made or that you plan to make. We will take any corrective actions into account when determining whether to take enforcement action (e.g., warning letter or FDA import alert).