Guidance on FDA's 'Importer' Definition in FSVP Regulations

• Will not be covered by the Food Safety Modernization Act preventive controls or produce safety rules;
• Is subject to the Preventive Controls for Human Food rule, and is not a “small business,” “qualified facility,” or subject to the Pasteurized Milk Ordinance; or
• Is subject to current good manufacturing requirements in the FSMA Preventive Controls for Animal Food rule, and is not a “small business” or “qualified facility.”

The final rule tasks the “FSVP importer” with conducting the activities required by the regulations (see 1511160014). Unless covered by an exemption or modified requirements, that importer must determine “known or reasonably foreseeable hazards” for each food, evaluate the food’s risk and the foreign supplier’s performance, use that risk evaluation to approve suppliers and determine supplier verification activities, and conduct those supplier verification activities and any corrective actions. For entries subject to FSVP, entry filers must submit the FSVP importer’s name, address, e-mail address and unique facility identifier in the form of a DUNS number (see 1705100028).

FSVP Importer Definition Covers U.S. 'Owner or Purchaser,' or U.S. Agent

According to FDA, the FSVP importer is a person who has a financial interest in the food and has knowledge and control over the food's supply chain, and may not be the same entity as the importer of record for customs purposes. The regulations define the FSVP importer as follows:

"Importer means 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 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 this subpart.”

The rule goes on to define the “U.S. owner or consignee” as “the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food.” In the section of its final FSVP rule addressing comments, FDA clarified that:

The FSVP importer may be the purchaser and not the owner. "Because there is a wide range of commercial arrangements between foreign owners and U.S. persons, there may be situations in which ownership of imported food has not transferred from the foreign owner at the time of entry to the United States, but a person in the United States has nevertheless purchased or agreed in writing to purchase the goods. We do not agree it is necessary to define the terms 'purchased' or 'purchase,' but we understand the terms to mean obtain by paying money or its equivalent."

'Time of Entry' means transmission of an entry to CBP. "The meaning of the phrase 'at the time of entry of such article into the United States' is ambiguous. It could mean that the importer is the U.S. owner or consignee at the time of submission of an entry or at the time that the article of food physically enters U.S. territory. We conclude that Congress intended that the importer be the U.S. owner or consignee at the time of submission of entry documents. Therefore, 'time of U.S. entry,' as used in § 1.500, is the time when an import entry is submitted to CBP either electronically or in paper form," FDA said.

The FSVP importer may not be the importer of record. "The importer of a food for FSVP purposes might be, but would not necessarily be, the importer of record of the food under CBP provisions (i.e., the individual or firm responsible for making entry and payment of import duties)," FDA said. "The 'U.S. owner or consignee' of a food, as we have defined the term, is more likely to have knowledge of food safety practices and control over the supply chain of an imported food than a customs broker, who often is the importer of record of a food for CBP purposes. Although the CBP definition of importer may be effective in ensuring collection of customs duties and otherwise meeting CBP requirements, that is not the purpose of the FSVP regulation. Consequently, the final rule adopts a definition of importer that best serves the purposes of the FSVP requirements, consistent with the statutory provisions the FSVP regulation must implement."

Retailer doesn't act as FSVP importer with third-party importer involved. In cases where a retailer contracts with a foreign manufacturer to produce private label products bearing the retailer's name, but the products are imported by and purchased from a U.S. third party, that retailer does not act as the FSVP importer, FDA said. "Provided a U.S. entity other than the retailer owns the food, has purchased the food, or has agreed in writing to purchase the food at the time of entry (i.e., is the 'U.S. owner or consignee'), the retailer would not be the FSVP importer of the food," it said. "In this situation, the importer is the U.S. firm that owns the product, has purchased the product, or has agreed in writing to purchase the product when it is offered for import into the United States and the entry documentation is submitted or presented. It would not be relevant that the retailer was the entity that entered into a contract with the foreign manufacturer (as long as the retailer is not the person in the United States that owns the food, has purchased the food, or has agreed in writing to purchase the food at the time of entry). If, on the other hand, the retailer owns the food, has purchased the food, or has agreed in writing to purchase the food at the time of entry (and thus is the U.S. owner or consignee), the retailer would be the FSVP 'importer.'"

Foreign exporter can't be FSVP importer. "The importer for FSVP purposes could not be the exporter in the foreign country in which the food was produced," FDA said. "If there is no U.S. owner or consignee of a food at the time of the food's entry into the United States, the foreign owner or consignee of the food must have validly designated a U.S. agent or representative ... to serve as the U.S. importer of the food for purposes of FSVP compliance."

U.S. Agent Must Be Based in U.S., Different From Registration Agent

In its final rule and other guidance issued by the agency, FDA clarified that the U.S. agent for FSVP purposes is not necessarily the same entity as the U.S. agent listed on food facility registrations. The FSVP U.S. agent must be based in the U.S., but need not be a U.S. citizen.

U.S. agent not necessarily a U.S. citizen. "If there is no U.S. owner or consignee at time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent," FDA said in its final rule. "The key is that there be a FSVP importer in the United States who takes responsibility for meeting the FSVP requirements." According to an FDA fact sheet, "the importer can be a foreign national residing in the United States and need not be a U.S. citizen."

FSVP and facility agents may be different. "Although Congress used the term 'United States agent'" in FSVP provisions and food facility registration provisions, "we do not interpret the use of the term 'United States agent' in [FSVP] to mean the U.S. agent for a foreign facility" for registration purposes, FDA said. "U.S. agents that foreign food facilities must designate for purposes of food facility registration perform a very different role than the 'United States agent' that a foreign owner or consignee may designate … to serve as the 'importer' for purposes of the FSVP regulations. For food facility registration, the 'U.S. agent' acts as a communications link. For FSVP, however, an importer (whether a 'United States agent' or otherwise) is responsible for the full breadth of supplier verification activities required under the FSVP regulation," it said. "We note, however, that this interpretation does not prohibit a foreign owner or consignee from designating a person who serves as a U.S. agent under the food facility regulation as the 'importer' for purposes of FSVP," FDA said. "Whomever the foreign owner or consignee designates also may be listed as a foreign facility's U.S. agent for food facility registration purposes."

U.S. agents for FSVP must be notified of role. Under the FSVP final rule, "in order for the foreign owner or consignee of the article to validly designate a U.S. agent or representative (when there is no U.S. owner or consignee) for purposes of the definition of 'importer,' the U.S. agent or representative's role must be confirmed in a signed statement of consent," FDA said. "The signed statement of consent must confirm that the U.S. agent or representative agrees to serve as the importer under the FSVP regulation. Because a signed statement is an explicit acknowledgment of consent, we conclude that a signed statement is an effective way of ensuring the consent of U.S. agents and representatives. In addition, we will be able to inspect the signed statements, should the need arise, allowing us to verify the accuracy of 'importer' designations under the FSVP regulation."

FSVP Importer Data Elements

Filers of entries subject to FSVP must submit the FSVP importer’s name, address, e-mail address and unique facility identifier (UFI). FDA will accept a DUNS number as a valid unique facility identifier, it said in recent guidance, though it will grant filers a grace period and allow submission of "unknown" for the DUNS number in cases where the FSVP importer has not yet been able to obtain one.

DUNS number accepted as valid FSVP importer unique identifier. According to a recent FDA guidance document (see 1703310030): "At this time, FDA recognizes the DUNS number, assigned and managed by Dun & Bradstreet, as an acceptable UFI for the purpose of compliance with the FSVP regulation."

Alternative FSVP importer identifiers not accepted. "FDA registration numbers would not be appropriate for FSVP importer identification purposes because not all 'importers' under § 1.500 will necessarily be facilities required to register under section 415 of the FD&C Act," FDA said in its final rule. "Likewise, not all importers under § 1.500 will necessarily be 'importers of record' for purposes of CBP entry submissions and therefore will not necessarily have CBP importer of record numbers. Any other CBP-required identifying information also would not necessarily identify the FSVP importer because CBP requirements do not incorporate the definition of 'importer' under § 1.500."

FSVP importer responsible for providing unique identifier. "Because a food's importer of record might not necessarily be the food's FSVP importer, we do not think that the requirement to provide the unique facility identifier should fall to the importer of record. Instead, we believe that it is appropriate for the requirement to apply to a person who is subject to the requirements of the FSVP regulation," FDA said. "Of course, the FSVP importer of a food might arrange to have the importer of record for the food provide the FSVP importer's identification information at entry. In any case, it is the importer's responsibility to ensure that the information identifying the importer is provided at entry by some entity."

FSVP importer email address to facilitate communication. FDA anticipates that it may use the FSVP importer email address submitted via ACE "to notify at least some of the persons listed at those addresses that they have been identified as FSVP importers, including persons who have been designated as the U.S. agent or representative of a foreign owner or consignee for purposes of the definition of 'importer,'" it said in the final rule. "We also might use electronic mail addresses to communicate with importers more generally, including to help us resolve any questions regarding a food offered for importation to potentially facilitate review of that food."