FDA Enables DUNS Use for FSVP Compliance ... Which Is Coming Due Soon
With the first compliance dates of FSMA’s Final Rule on Foreign Supplier Verification Programs (FSVP) just around the corner, FDA has issued guidance formally recognizing the Data Universal Numbering System (DUNS) number as an acceptable unique facility identifier (UFI). While this is good news, simplifying things for many who already use DUNS numbers, it may be an abrupt reminder for some who have been so focused on other aspects of FSMA compliance (and simply running the business) that this import rule slipped through the cracks.
So, to bring everyone up to speed and provide a reminder of what this rule is all about, following is a Q&A with a general overview of the rule and to whom it applies, information on FDA’s DUNS allowance, and the upcoming compliance dates.
What is FSVP?
FSVP is a FSMA-mandated program by which importers of food into the U.S. perform certain risk-based activities to verify that their foreign suppliers are producing food to the same level of public health protection as that required by the preventive controls or produce safety rules. It also ensures the supplier’s food is not adulterated or misbranded with respect to allergen labeling.
The rule requires that importers determine known or reasonably foreseeable hazards of each food and evaluate the associated risk, then use the risk evaluation to approve suppliers and determine and conduct appropriate supplier verification activities. The importer must also conduct corrective action, as applicable. As with many provisions of FSMA, this approval process must be written, with a separate FSVP for each food and each supplier of the food. The risk evaluation must be reassessed at least every three years, or when there is new information on a potential hazard or the foreign supplier’s performance.
When necessary on a temporary basis, importers may attain foods from unapproved suppliers if those foods are subjected to adequate verification activities before being imported. Additionally, the importer is not required to conduct an evaluation or supplier verification activities if a food is to be further processed by a subsequent entity in the distribution chain, as long as they receive adequate assurances that the food is to be processed for food safety in accordance with applicable requirements and they disclose in documents accompanying the food that the food is not processed to control the identified hazard.
Who is subject to FSVP?
In simple terms, FSVP applies to businesses that import food for humans and/or animals. But, as is often the case with government regulation, it’s not really that simple. That is, if you are “the U.S. owner or consignee of an article of food that is being offered for import into the United States; or, if there is no U.S. owner or consignee of an article of food at the time of U.S. entry, you are the U.S. agent or representative of the foreign owner or consignee at the time of entry” ... then you are subject to FSVP. Well, that is, unless you meet further exemptions or modifications, such as importing only certain USDA-regulated meat, poultry, and egg products; transshipped food; certain juice or juice ingredients; low-acid canned foods, etc.; you are a receiving facility in compliance with the Preventive Controls supply-chain provisions; you are a very small importer; etc. To find out if your business is subject to the rule or modifications, click over to FDA’s flow chart: Am I Subject to FSVP?
What is the UFI for which FDA now accepts DUNS?
The FSVP rule requires that an importer provide its legal business name, electronic mailing address, and a unique facility identifier (UFI) for each line entry of food product offered for importation into the U.S. FDA previously stated that it expected to recognize DUNS numbers as an acceptable UFI, but it was only on March 31 that the agency formally recognized it as acceptable. As stated in the announcement, “The identification of importers will help the FDA effectively implement, monitor compliance with, and enforce the FSVP requirements, which are designed to help ensure that imported foods meet U.S. safety standards.”
When do I need to comply?
Again, as is standard with FSMA, compliance dates vary according to a number of factors, including importer size, nature, and compliance with other FSMA rules. Following is a general overview of upcoming compliance dates and a link for more specifics:
All other FSVP importers have until at least March 2018 to comply with the rule. (See FDA’s FSVP Compliance Date document for further details.)
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