Common 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 recently issued final guidance document on FSVP – though we’ve taken the liberty of taking out some of the government-speak and combining some questions. Please note that even though it’s referred to as a final document, updates can still happen.
Q: How do I determine if I am an importer of a food for the purposes of the FSVP regulation (FSVP importer) and must the FSVP importer be in the U.S.?
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.
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. 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: Can an entity who is not the FSVP importer assume the importer’s responsibilities for developing, maintaining, and following the FSVP regulation?
A: No. The FSVP importer can identify qualified individuals to perform certain FSVP activities on the importer’s behalf –in some circumstances, provided that the importer conducts a required review and assessment of the individual’s activities. But the FSVP importer is the entity with the responsibility for developing, maintaining, and following the FSVP regulation.
Q: Would a U.S. retailer that places a purchase order with a U.S.-based food distributor be considered the “U.S. owner or consignee” if the retailer does not specify the source of the food and the distributor is the entity that purchases the food directly from the foreign supplier?
A: If the retailer does not direct the U.S.-based distributor to purchase the food from a particular source or sources, the retailer would not be the “U.S. owner or consignee.” For example, if a retailer places a purchase order for bell peppers from a U.S.-based distributor without specifying the source of the peppers, the retailer would not own, have purchased or have agreed in writing to purchase the food. The retailer would have only placed an order directing the distributor to obtain peppers, leaving the decision about the source of the peppers to the distributor. At the time of entry, the distributor is the entity that purchased the peppers. Therefore, the distributor would meet the “U.S. owner or consignee” definition.
Q: Who is the foreign supplier of a food?
A: The foreign supplier of a food is the establishment that manufactures/processes the food, raises the animal or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature. Because of this, your foreign supplier might not be the entity from which you directly obtain the food you import. If you obtain a food from a foreign warehouse, distributor, broker or other entity that does not perform any manufacturing/processing of a more-than-de minimis nature, the foreign supplier of the food would be the last entity in the foreign supply chain that conducts significant manufacturing/processing of the food.
Q: May an entity that only packs or holds food be a foreign supplier?
A: No. Although an establishment that only packs or holds food might be a food facility that is required to register with FDA, it is not a foreign supplier. Packing, cooling and holding performed by a packing house (that only packs and holds produce and cools the produce incidental to packing and holding) would not make the packing house the foreign supplier, because these activities would not be considered manufacturing/processing but only packing and holding. Waxing, sorting, culling, conveying, and storing of RACs would generally be considered packing or holding.
Q: Under what circumstances is a food that I import for research or evaluation exempt from the FSVP regulation? What does “research or evaluation” of an imported food mean?
A: The FSVP regulation does not apply to food you import for research or evaluation use, provided that: • The food is not intended for retail sale and is not sold or distributed to the public;
You should take steps to ensure that the label statement “Food for research or evaluation use” is securely attached to the food so that it remains on the food until the food is used for research or evaluation. You should ensure that the label statement is not removed to facilitate sale or distribution of the food to the public.
Research or evaluation of a food for humans may involve analyzing food for characteristics such as protein or fat content, testing or observing physical characteristics such as color or texture and sensory analysis or evaluation, such as organoleptic analyses for testing the quality of tea. It may also include research for marketing purposes.
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. However, the exemption for research or evaluation would apply to food used in a defined study, conducted during a trade show, of a food involving a discrete set of test subjects who have agreed to participate in the study. In such a circumstance, we would not consider the food to be sold or distributed to the general public.
Q: How do I indicate at entry that a food is exempt from the FSVP regulation?
A: When filing entry with CBP, the filer should transmit the Affirmation of Compliance code “FSX” for the following foods that are exempt from the FSVP regulation:
For food imported for research or evaluation that is exempt from FSVP in accordance with 21 CFR 1501(c), the filer should transmit the Affirmation of Compliance code “RNE” instead of “FSX.” If the food is not subject to the FSVP regulation because it is “U.S. food returned,” the filer should also specify the United States as the FDA Country of Production in the entry documentation.
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: 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, peanut, sesame and soybeans.
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:
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. 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:
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:
Q: What are the general requirements for maintaining FSVP records?
A: You must keep records as original records, true copies (such as scanned copies,) 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: How long must I retain my FSVP records?
A: You must retain required FSVP records for at least 2 years after you created or obtained the records (with certain exceptions discussed below). For example, if you take a corrective action after determining that a food you import was adulterated (e.g., you work with the foreign supplier to ensure that the problem is corrected before you again offer the food for importation into the United States), you must retain documentation of the corrective action you took for at least 2 years. You must retain records relating to your FSVP processes and procedures, including the results of evaluations and determinations you conduct, for at least 2 years after you discontinue using the process or procedure.
We would consider a process or procedure discontinued if, among other things, you no longer import a particular food, you no longer obtain food from a particular foreign supplier, you reevaluated the foreign supplier’s performance and the risks associated with a food, or you changed your supplier verification activities for a particular food and supplier. For example:
Q: How will FDA determine if I am in compliance with the FSVP requirements?
A: FDA may review your FSVP records to evaluate your compliance with the FSVP requirements. This review might be at your place of business or remotely, through an official written request to send records relating to your FSVP activities to the agency. We will review required FSVP records relating to one or more of the foods you import, including the following records, when applicable:
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).
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