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Have questions about the FDA FSMA rule on Foreign Supplier Verification Programs?

An expert provides some answers.

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The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for importers of food for humans and animals has been finalized. Requiring importers to perform certain risk-based activities to verify food imported into the US has been produced in a manner that meets applicable US safety standards, the rule contains elements of the original and supplemental proposals, plus increased flexibility in meeting certain requirements. Despite the fact the first compliance date was May 30, you may have some questions about the new rule and its implementation.

According to Sharon Mayl, senior advisor for policy in the Office of Foods and Veterinary Medicine at FDA, the May 30 compliance date affects US importers with foreign suppliers that will not be covered by the preventive controls (PC) or produce safety rules; are subject to the PC for Human Food rule and are not  “small businesses” or “qualified facilities” (certain very small businesses) or subject to the Pasteurized Milk Ordinance; or are subject to the CGMP requirements in the PC for Animal Food rule and are not small businesses or qualified facilities.

Importers have some flexibility with respect to the PC and produce safety rules, but they need to have a program that allows them to demonstrate their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produce rules. Importers can expect interactive FDA inspections with opportunities to explain how their programs meet the agency’s requirements and how the agency will take corrective actions if deficiencies are observed.

Mayl adds: When any food regulated by the FDA is offered for entry into the US, the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements. An FSVP importer subject to the May 30 compliance date should use the entity role code “FSV,” indicating the entry is subject to the FSVP regulation. This will prompt the ACE system to ask for the importer’s name, email address and unique facility identifier (UFI) recognized as acceptable by the FDA.

However, if the food entry line is exempt from the requirements of FSVP or not yet subject to the rule, the filer should use one of two Affirmation of Compliance codes, either “FSX” (designating that the food is exempt from FSVP or that compliance with FSVP is not yet required) or “RNE” (designating, more specifically, that the food is exempt from FSVP because it will be used for research or evaluation in accordance with 21 CFR 1.501[c] of the FSVP regulation). If one of these codes is not transmitted for an imported food product under FDA jurisdiction, the entry line will be rejected.

For a limited time, importers can submit the value “UNK” (to represent “unknown”) in the entry data field where the (Data Universal Numbering System) DUNS number would have been provided for an FSVP importer. This will give importers extra time to obtain their DUNS numbers and will provide the FDA with a list of FSVP importers it can contact to ensure they understand and are taking the necessary steps to meet the FSVP requirements.

Mayl offers the following advice to importers subject to the FSVP rule that are not affected by the May 30 compliance date: Obtain a DUNS number prior to your compliance date, ensure you know the requirements of the FSVP rule, begin putting together your FSVPs and, if appropriate, conduct verification activities prior to your compliance date(s).


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