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In its second round of final FSMA rules, FDA published the requirements for the new Foreign Supplier Verification Program (FSVP) for Importers of Food for Humans and Animals. The rule was fulfillment of Congress’ directive for FDA to develop regulations by which importers would have to perform risk-based foreign supplier verification activities. As such, the rule requires each importer to implement FSVPs to provide assurance that its foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls, to provide the same level of public health protection as that required of U.S. producers. The regulation is designed to be flexible based on risk, and the requirements vary based on the type of food product and category of importer. It is intended to be “sufficiently general and flexible to apply to a variety of circumstances without being unduly burdensome or restrictive of trade.” FSVP focuses in on known or reasonably foreseeable food safety hazards – rather than on all adulteration, and it aligns with key components of the food safety plans and supply-chain program provisions of the preventive controls (PC) rules. Revisions in the final rule also provide added flexibility for importers in determining appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods. The final rule is intended to better reflect modern supply and distribution chains. What is required under FSVP? The rule focuses on the responsibilities of the importer – defined as the U.S. owner or consignee of a food offered for import into the U.S. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent. Under the FSVP regulation, importers are responsible for: Identifying themselves as the importer of the food for each line of food product imported. Determining the hazards reasonably likely to cause illness or injury with each food. Importers can conduct their own analysis or review and assess that conducted by another entity. Evaluating the risk posed by a food, using the results of the hazard analysis, and evaluating the foreign supplier’s performance. Then using these results to approve (or not approve) a foreign suppliers and determine appropriate supplier verification activities. Again, importers can conduct their own evaluation or review and assess the evaluation and/or determination of another entity. However, the importer must approve its own foreign suppliers. The risk must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance. Conducting supplier verification activities for each foreign supplier before importing a food and periodically thereafter. In general, importers must establish and follow written procedures to ensure they only import foods from approved foreign suppliers. (Temporary imports from unapproved suppliers are allowed when necessary and appropriate, if adequate verification activities are performed on the food before its import.) With the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics, the importer is to determine and document foreign supplier verification activities and their frequency that assure that hazards are significantly minimized or prevented. Appropriate verification activities include onsite auditing, sampling and testing of a food, review of the foreign supplier’s relevant food safety records, etc. Performing other appropriate activities. The importer is not required to conduct supplier verification or risk evaluation when the hazard will be controlled by a subsequent entity in the U.S. However, if the hazard will be controlled by a subsequent entity, the importer must disclose that the food has not been processed to control the identified hazard, and provide written assurance of processing for food safety throughout the distribution chain. Conducting corrective actions if a foreign supplier does not produce the food in compliance with these rules. The appropriate action will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause has been adequately addressed. Retaining records of FSVP activities. Are there any exemptions or modified provisions? FSVP requirements apply to most imported food under FDA’s jurisdiction, but there are exemptions for certain juice, fish, and fishery products (which are already subject to HACCP regulations); food for research or evaluation; food for personal consumption; alcoholic beverages; food that is transshipped; food imported for processing and future export; food exported from and returned to the U.S. without manufacturing/processing in a foreign country; and certain meat, poultry, and egg products regulated by USDA. Additional exemptions and modifications include: Dietary supplements/component importers who verify compliance with certain specifications under the dietary supplement cGMP regulations and importers whose customer is required to establish and verify compliance with written assurance – would not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. Importers of other dietary supplements – would not be required to conduct hazard analyses, and their supplier verification activities will focus on verifying that the supplier is in compliance with the dietary supplement cGMP regulation. Very small importers and importers of food from certain small foreign suppliers – have modified FSVP requirements (with the definitions of “very small importer” aligned with that of the PC rules). Importers of food from qualified facilities under either of the PC rules, non-“covered farms” under the produce safety rule, and shell egg producers with fewer than 3,000 laying hens – have modified requirements, such as not being required to conduct a hazard analysis and can verify their foreign suppliers by obtaining written assurance of their supplier’s compliance with the applicable food safety regulations. Also excluded from most of the standard FSVP requirements are certain types of food from a foreign supplier in a country whose food safety system has been recognized by FDA as comparable or determined to be equivalent to that of U.S., provided that the food is within the scope of the recognition or determination; the importer determines that the foreign supplier is in compliance with the relevant food safety authority; and the food is not intended for further processing in the U.S. To date only New Zealand has met these requirements. Additionally, importers that are also manufacturers/processors will be in compliance with most FSVP requirements if they are in compliance with the supply-chain program requirements under the PC rules; they are in compliance with the PC rules for the hazards in the food; or they are not required to implement preventive controls under those rules and they comply with requirements for disclosures and written assurances. When must you comply? Compliance dates begin May 27, 2017 (18 months after the publication date of November 27, 2015). Longer times are allowed for: The importation of food from a supplier that is subject to the preventive controls or produce safety rules, with compliance required six months after the foreign supplier is required to meet the relevant regulations. An importer that is manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations must comply by the date by which it has to comply with those provisions. To assist industry in compliance, FDA is developing guidance and collaborating on training on the FSVP rule and developing guidance on how to obtain the expertise to be a qualified auditor. You Import Food: What Does the New FSVP Rule Mean to You? by David Acheson is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. 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. Learn more at: www.AchesonGroup.com

You Import Food: What Does the New FSVP Rule Mean to You?