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TAG November 7, 2019 0 Comments

In its October publication on record requirements for the Foreign Supplier Verification Program (FSVP) FDA takes a question & answer approach, addressing standard and modified requirements for this supply chain program. According to the standard requirements, unless exempt, all importers of human and animal food must develop, maintain, and follow an FSVP for each foreign supplier and food. The publication provides links to further specific enforcement policies; specific details for low-acid canned food (LACF) – which are not required to address some microbiological hazards; and options for importers subject to preventive controls – which may choose to comply with the applicable preventive controls regulation or with FSVP. The Standard Requirements section also discusses the need for records related to: Hazard analysis and reevaluation, performed by a qualified individual, to include identification of known or reasonably foreseeable hazard, evaluation of identified hazards for probability and severity of occurrence in the absence of controls, and evaluation of environmental pathogens if an RTE food is exposed and no control is implemented. Alternatively, records can be kept of the review and assessment by another qualified individual. Reevaluation is to be conducted every three years in the event of a change. Foreign supplier approval evaluation. The evaluation is to document the supplier’s performance and the risk posed by the food, the approval of the supplier based on this with consideration of the hazard analysis and entity(ies) conducting or verifying hazard controls along with the supplier’s performance. Reevaluation every three years or for any changes to determine the appropriateness of current relationship and activities, and any corrective action. Again, documentation can be of the evaluation by another qualified individual. Verification and related activities. Importers are to develop and implement procedures for importing food only from approved foreign suppliers, and for unapproved suppliers when necessary and appropriate, as well as for determining the supplier verification activities that are to be conducted and ensuring they are. The performance of verification activities is to be assessed by an onsite audit, sampling and testing of the food, review of the supplier’s food safety records and other such assessment. All is to be documented whether conducted oneself of by another qualified individual. Corrective action. Records are to be kept of any corrective actions taken, investigations, and resulting FSVP modifications. Importer ID. Importer identification is to be provided electronically when filing entry and before the food is imported/offered for import. FDA details Modified Requirements for three specific types of importers/foreign suppliers: 1. Food that cannot be consumed without the hazards being controlled is subject to modified record requirements including a hazard analysis of the determination of this, and: If the customer is subject to the Preventive Controls rule, a document is to accompany the food stating “not processed to control [identified hazard]” and a signed, dated annual written assurance from the customer that it has procedures for hazard prevention/control. If the customer is not subject to the Prevent Controls rule, the same document is to accompany the food, and there must be signed, dated annual written assurance from the customer that it is implementing applicable food safety regulations. If an entity in the supply chain subsequent to the customer controls the hazard, the document must accompany the food through to the subsequent recipient and signed, dated customer assurance is to state that this is done, that customer will sell food only to an entity that agrees, in writing, to significantly minimize or prevent the hazard. If the importer has an established, implemented system to ensure customer or subsequent entity controls the hazard, this is to be documented. 2. Dietary supplements also have modified record requirements, including: Importers subject to CGMPs are to use a qualified individual and auditor, when applicable. In addition to the above, importers whose customer is subject to CGMPs are to document annual, signed and dated assurance that the customer is in compliance with requirements. If neither the importer nor its customer is subject to the CGMPs, a full documentation of the risk evaluation, procedures for and use of importing food from approved and unapproved foreign suppliers, supplier approval and reevaluations, correctives actions, supplier verification activities and frequency is to be included. All are to document the foreign supplier verification activities by onsite audit or inspection and results thereof, sampling and testing, review of the supplier’s food safety records, and other verification activities, and any corrective actions, investigations, and related FSVP modifications. 3. Importers that are very small or import from certain small foreign suppliers can qualify for modified recordkeeping to include: Very small importers that meet the definition before importing food and annually thereafter are to have bi-annual written assurance that the foreign supplier is producing food in compliance with food safety processes and procedures, record of corrective actions if written assurance not met, and use of qualifed individual and auditor when applicable. Records of qualification a very small are to be retained for at least three years. Importer from small foreign qualified facility is to have bi-annual written assurance that the food is produced in compliance with FDA food safety regulations (or those of its country if FDA recognized as equivalent) to include description of preventive controls or statement of compliance. Importers of non-“covered produce” from small foreign supplier and of shell eggs from small foreign supplier with fewer than 3,000 laying hens must have bi-annual acknowledgement that that food is subject to section 402 of the FD&C Act (or those of its country if FDA recognized as equivalent). All importers of food from small foreign suppliers must have annual written assurance that the supplier meets the criteria for “small” and maintain records of the initial evaluation of the supplier’s compliance history, any corrective actions taken, reevaluation every three years or in the event of a change, approval of foreign supplier, procedures for and use of only approved foreign suppliers, procedures for and use of non-approved suppliers when necessary, and use of a qualified individual and auditor, as applicable. In all cases, whether meeting standard or modified requirements, importers are to keep all records as original or electronic records or true copies for at least two years. They must be legible, signed and dated, available within 24 hours to FDA in English (or translated within a reasonable time) upon request. They are to be kept at least two years. If importing from a country that is FDA-recognized as equivalent, records are to document that the supplier is under the regulatory oversight and the food within the scope of the recognized system, and the supplier is in good compliance standing. Compliance with the FSVP rule can be complex, and ensuring you maintain the correct records to show your compliance is critical should your imported product ever come into question at the border – or in your facility, or should there be an FDA inspection of your operation. Supply chain risk continues to be the fastest-growing threat for most companies, but ensuring your FSVP is in place and accurate can actually reduce that threat. Let TAG’s expert team show you how. 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.


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