A few weeks ago, we got our first call from an importer who had received a 483 from FDA for lack of compliance with FSMA’s FSVP. There was one observation that basically said, “you are not compliant with FSVP.” We felt that it was important to alert our readers that FDA is not only doing FSVP inspections but issuing 483s for noncompliance. While a number of importers have had to comply with the FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of food since May 2017, many more will be subject to compliance within the next few months. Because of this and the enforcement behavior of FDA, we thought it of benefit to review some aspects of the rule as well as the past and pending compliance dates. In brief, the FSVP final rule, published November 27, 2015, requires that importers perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that meets applicable U.S. safety standards. In developing the final rule, FDA included elements of both its original and supplemental proposals, but added importer flexibility for meeting certain requirements to better reflect modern supply and distribution chains. Importers can meet key FSVP obligations themselves or by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as the importer reviews and assesses the documentation. Key FSVP Requirements The rule is focused toward importers, defined as the U.S. owner or consignee of a food offered for import into the United States. If there is none, it is the U.S. agency or representative of the foreign owner of consignee at the time of entry. To comply with the rule, importers subject to FSVP must have a program in place to verify that their foreign suppliers are “producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.” Specific actions for which importers are responsible are included in the rule. Additionally, importers are required to identify and evaluate—based on experience, illness data, scientific reports and other information—the known or reasonably foreseeable biological, chemical and physical hazards for each type of food it imports to determine if there are any hazards requiring a control. The hazards may be naturally occurring, unintentionally introduced, or intentionally introduced for purposes of economic gain. Risk is to be evaluated as related to the imported food and a supplier’s performance, including its hazard analysis; the entity that will be significantly minimizing or preventing the hazards; foreign supplier’s procedures, processes and practices related to the safety of food; the foreign supplier’s compliance with applicable FDA food safety regulations and its food safety history; as well as other applicable factors, such as storage and transportation practices. Based on the risk evaluation, the importer must establish written procedures to ensure it only imports from approved foreign suppliers and conduct appropriate supplier verification activities. These activities can be tailored to unique food risks and supplier characteristics, but are to be evaluated through annual on-site audits of the supplier’s facility or another means of verification that is appropriate and applicable, sampling and testing, or review of the supplier’s relevant food safety records. If it is determined that a foreign supplier has not used appropriate processes and procedures, has produced adulterated food, or mislabeled food relevant to allergens, the importer must promptly take corrective actions, such as discontinuing use of the foreign supplier until the cause has been adequately addressed. The rule also provides for exemptions or modified standards for dietary supplements, small and very small importers/suppliers, certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the United States’ system; and certain categories of foods. FSVP Compliance The compliance dates for importers subject to the FSVP rule differ according to a number of considerations, including size of the foreign supplier, nature of the importer, and whether the foreign supplier must meet the requirements of the Produce Safety or Preventive Controls for human or animal food rules. Compliance dates are based on the latest of the following: 18 months after publication of the final rule; for the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations; for importers that are manufacturers or processors subject to the PC rule supply-chain program provisions, the date by which that compliance was/is due. Thus, importers that should already be in compliance include those whose foreign supplier is not subject to the PC or produce safety rules and most larger business that don’t meet any of the qualified exemptions. Those nearing March or July compliance dates include many small businesses and those larger businesses which had extended compliance dates, such as importers whose foreign supplier is subject to the animal foods PC requirements or Produce Safety Rule. (For the full list, see FDA’s FSVP compliance dates.) It also is important to note, however, that FDA has extended the compliance dates for certain provisions of this and three other rules, providing an additional two years for compliance with the FSVP requirements for the importation of food-contact substances and certain provisions concerning written customer assurances. If you need help with compliance with the FSVP program, don’t hesitate to give TAG a call. We would be happy to work with you to help you on your way to compliance with this part of FSMA. 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
