Are you a little confused and bewildered about the FSVP requirements? Have you tried to sort your way through the various guidance documents that FDA has published recently? In this newsletter, we will try to add a little clarity as to who should do what and when. The first question is: Have you set up a unique facility identifier for each of your foreign food or ingredient suppliers? With the first of FSMA’s Foreign Supplier Verification Programs (FSVP) compliance dates in less than two weeks – May 30, to be exact, it’s time to be double checking the rule, your foreign suppliers, and your imported foods and ingredients to determine who’s in and who’s out. Following are a few of the basics of the rule to help you. To whom does the May 30 compliance date apply? If you are an importer with a foreign supplier who: Will not be covered by the FSMA 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 the cGMPs of the FSMA Preventive Controls for Animal Food rule, and is not a “small business” or “qualified facility”; you are required to be in compliance by May 30. What does this mean? It means that you must provide specific identification for each line entry of food product offered for importation into the U.S., including the FSVP importer’s name, e-mail address, and Unique Facility Identifier (UFI) recognized as acceptable by FDA. What is an acceptable UFI? As we discussed in our newsletter of April 13, FDA Enables DUNS Use for FSVP Compliance … Which Is Coming Due Soon, FDA recently issued guidance recognizing the Data Universal Numbering System (DUNS) number as an acceptable UFI – simplifying things for many who already use DUNS numbers. You may also want to take a look back at that newsletter for a more in-depth review and refresher on exactly what FSVP is. How does the system work? When a food product under FDA oversight is offered for entry into the U.S., the U.S. Customs and Border Protection Automated Commercial Environment (ACE) system will prompt the filer to insert a code this will either be FSV, FSX or RNE – see below If the food is subject to FSVP then enter FSV – This will send a signal to the ACE system indicating the entry line is subject to the FSVP regulation and will trigger a request for the FSVP importer’s name, email address, and DUNS number. If the food is for research or evaluation enter RNE If the food is exempt from the requirements of the FSVP regulation, or not yet subject to the regulation based on the applicable compliance date enter FSX. , If one of these codes is not entered, the entry line will be rejected. Is FDA giving any leeway on the compliance date? Yes! Because FDA recognizes that this is a new requirement and there may be factors that prevent importers from providing their UFI on the applicable compliance date, FDA’s new guidance states that FSVP importers who are temporarily unable to obtain a DUNS number may list “UNK” (“unknown”) in the UFI field, enabling the food to be processed through the system. However, FDA will be contacting importers that use UNK to discuss the FSVP requirement and ensure they can take appropriate steps to obtain a UFI. Additionally, as a temporary initiative, the agency will update the guidance when UNK is discontinued. If none of the three qualifications (of the first answer) applies to me/my foreign supplier, am I subject to the rule? You may be. FDA provides a chart to help you determine if your firm is subject to the rule, available at Am I Subject to FSVP? Compliance dates related to each factor, as well as those for small businesses and qualified facilities are listed at FSVP Compliance Dates. We have said before that if you are compliant with the PC rule then you are exempt from the FSVP. The Am I Subject to FSVP chart confirms this; but remember that you will still need the importer identification at entry. Why do we need the FSVP rule? As discussed in an online Q&A with Dr. Donald A. Prater, FDA Acting Assistant Commissioner for Food Safety Integration, the U.S. import safety program has traditionally consisted of inspecting foreign facilities that import food into the U.S. and inspecting shipments at the port of entry. But with the significant increase in the volume of imports and the number of registered firms, it is difficult for the traditional model to keep pace. As such, imported foods are being held to new requirements to help ensure food-safety, prevention-based actions are implemented before the food reaches U.S. borders. One of these new tools is FSVP, requiring importers to verify the safety of the food they import, with FDA inspecting importers to make sure they are doing so. Does FDA provide any other resources or information on the rule? Yes. Along with the new guidance, FDA has provided a number of other informational documents, including (the guidance) Compliance with Providing an Acceptable Unique Facility Identifier for Foreign Supplier Verification Programs Regulation: Guidance for Industry FSVP Final Rule At-a-Glance Printer-Friendly Fact Sheet FSVP Compliance Dates Food Safety Preventive Controls Alliance Training Courses FSVP is very new to many and while FDA is clearly on a learning curve just like everyone else, we encourage you to at least be making headway with the basics of what you need to do to be compliant. Make sure you are working on your list of imported foods and undertaking the required hazard analysis and subsequent verification of risks that need a control. Still bewildered? – Call us at TAG; we can help. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
