Supplier verification, as mandated by the Food Safety Modernization Act (FSMA), evokes sentiments such as the Russian proverb “trust but verify” or the expression “don’t buy a pig in a poke.” Food manufacturers are now required to monitor the origins of their ingredients closer than ever before. The FSMA food supply chain program requirements expect food facilities and importers to understand the food compliance history of their suppliers. But should firms also be expected to verify the controls of their suppliers’ ingredient suppliers?

Supplier verification, as part of a supply chain program, is a critical element of three FSMA regulations developed by the Food and Drug Administration (FDA): Foreign Supplier Verification Programs (FSVP) for Importers, Preventive Controls for Human Food and Preventive Controls for Animal Food.  

The Preventive Controls rules compel firms to evaluate a supplier when the supplied ingredient contains a food safety hazard requiring a supply chain control. According to the Foreign Supplier Verification Program (FSVP) rule, importers must verify their suppliers have met all U.S. food safety standards.  

Additionally, aligned with the supplier evaluation process, the FDA issued a draft guidance, Chapter 15: Supply-Chain Program for Human Food Products, and the related draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals in January 2018. Both guidance documents recommended verification activities that have been deemed impractical and “resource intensive” by several U.S. food industry associations.

To support the evaluation of the past performance of a supplier, the FDA recently expanded its Data Dashboard tool with a new online search function that allows manufacturers to review the compliance history of a supplier. The Supplier Evaluation Resources database provides access to FDA records to determine if a supplier has been the subject of an FDA warning letter, import alert or other FDA compliance action related to food safety.

However, while the new Supplier Evaluation Resources site will enable firms to search multiple FDA databases in order to evaluate their suppliers’ past performance, the FDA has cautioned that the search tool “will not likely satisfy importers’ and facilities’ supply-chain verification obligations because the dashboard search encompasses only finalized and completed FDA actions.”

Industry Seeks Flexibility  

Following the release of the FDA guidance documents, several industry trade groups, including the American Frozen Foods Institute (AFFI), American Spice Trade Association (ASTA), Grocery Manufacturers Association (GMA), and National Association of Chemical Distributors (NACD) submitted comments that urged the FDA to reconsider certain recommendations. Several comments asked the FDA to provide greater flexibility for firms to meet specific requirements for supplier verification as mandated by the rules for FSVP and preventive controls.

A common theme identified within industry comments concerned the recommendation in both guidance documents that a firm must verify the controls of a supplier’s supplier or an indirect supplier. For example, take a food manufacturer who makes a chocolate chip cookie dough ice cream product and sources the cookie dough from an ingredient supplier. The indirect supplier to the ice cream manufacturer would be the company that supplies chocolate chips to the cookie dough manufacturer. If a hazard is controlled by the chocolate chip company, then the manufacturer of the ice cream would be expected to verify the chocolate chip supplier by either reviewing the cookie dough manufacturer’s supplier verification program or by conducting its own supplier verification of the chocolate chip company.

The recommendations for the verification of indirect suppliers is opposed by several trade groups. As stated in several comments, if a contractual agreement does not exist between the importer or receiving facility, then there is no commercial or regulatory obligation for the indirect supplier to share proprietary information about its food safety program. Moreover, the process of conducting supplier verification of indirect suppliers or reviewing the supplier’s verification records for each supplier would require considerable resources.

The American Frozen Foods Institute was aligned with other industry groups when it suggested that the FDA should “permit firms to confirm their direct suppliers have good supplier approval and verification programs in place to verify their suppliers are controlling hazards, without reviewing the supplier’s documentation for each of its suppliers.”

Additional Supplier Issues to Consider

While the verification of indirect suppliers was a key issue identified by several trade groups, the industry comments on the draft guidance documents highlighted additional issues for FDA to consider, including:

  • Use of Third-Party Audits – In comments submitted by AFFI, the FDA was urged to “allow receiving facilities and importers to continue using systems-based audits conducted by reputable third-party auditors against established food safety schemes as a verification activity.”
  • Ingredient Testing – The NACD and Grocery Manufacturers Association (GMA) both commented on the recommendations for ingredient testing. The draft guidance provided suggestions for when firms should conduct testing on food or raw materials obtained from suppliers. The NACD comments noted the “FDA should revise these recommendations to be consistent with the industry practice of ‘test and hold’ to avoid recall situations.”  
  • Supplier’s Allergen Controls – AFFI has requested “that FDA allow firms to verify that the supplier has established a strong allergen labeling and management program, rather than confirm the allergen declaration for all food or material obtained from the supplier.”
  • Records Review – The preventive controls rule requires the review of supplier verification program records as a verification activity. AFFI has asked the FDA to provide “guidance regarding how companies should decide the frequency of this activity and the level of detail of the review performed.”

In the case of “co-manufacturing” agreements, in which a brand owner contracts with a second party to manufacture or process the food, the regulations require co-manufacturers to approve their ingredient suppliers and to conduct supplier veri­fication activities. The FDA has postponed enforcement of these requirements to permit fi­rms additional time to establish new contracts between brand owners and co-manufacturers to share certain information, such as supplier audit results.

The food industry had previously challenged the FSMA requirement for ‘written assurance’ statements related to situations in which food safety controls would be applied downstream by a customer of a manufacturer/processor. In January, the FDA issued a guidance that indicated the agency will re-evaluate supply chain issues related to this requirement and would exercise enforcement discretion indefinitely.  

Supplier verification and compliance are vital activities for ensuring the safety and authenticity of a food product. To facilitate industry compliance with FSMA, the FDA has modified its regulatory approach in response to specific industry concerns, and the agency might revise certain requirements for supplier verification in response to the latest industry comments. Going forward, the implementation of FSMA rules requiring supplier verification will emphasize the need for facilities and importers to be aware of the safety of every portion of their supply chain, including the compliance history of its suppliers.

Are you prepared to implement rigorous supply chain monitoring at your company? Do you need help organizing your supply chain management to move beyond manually monitoring spreadsheets with information from multiple suppliers? Mérieux NutriSciences’ web-based application, QualMap, allows manufacturers to easily monitor their products, ingredients and overall supply chain. This solution gives you quick access to reporting to keep you informed on how your brand is performing and mitigate risks early. Want to learn more about the QualMap digital solution? Stream our free, on-demand webinar now for more information!

Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

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