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FDA again extends time to comply with FSMA's supply chain provision

Two-year enforcement discretion not long enough to fix FSMA problem with supply chain verification for co-manufacturers

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Frozen food companies are praising FDA for extending enforcement discretion on a supplier verification and approval provision of the Food Safety Modernization Act (FSMA) – scheduled to run out Nov. 6 – after two years were not enough to work out a solution.

At issue are FSMA provisions in the preventive controls and import rules designed to ensure suppliers are addressing hazards through the supply chain and, in this case, when receiving facilities are co-manufacturers.

But the problem comes when co-manufacturers need detailed information about suppliers that only the brand owner has, and that cannot be shared because of confidentiality clauses in the contracts, FDA said Wednesday.

With the hope of working out a solution, FDA announced in November 2017 it would use enforcement discretion until Nov. 6, 2019, allowing brand owners to work with suppliers to adjust contracts so the information could be shared. But the two-year extension was not enough, the agency said.

“Since that time, FDA has learned of additional challenges industry is facing in trying to meet the supply-chain requirements,” FDA said. “The FDA will continue its enforcement discretion policy while advancing its work with stakeholders to better understand these challenges and to consider possible solutions to address these situations.”

The frozen food industry praised FDA on Wednesday for listening to its pleas for more time.

“AFFI commends FDA for providing co-manufacturers and brand owners with additional time to overcome contractual and logistical barriers to compliance with the supplier verification requirements,” said AFFI President and CEO Alison Bodor.

AFFI joined the Grocery Manufacturers Association (GMA), National Confectioners Association (NCA), the American Bakers Association (ABA), United Fresh Produce Association, and other groups in the Food and Beverage Issues Alliance who had asked FDA to extend the two-year reprieve to find a fix to the compliance problem.

In September, Betsy Booren, GMA’s senior vice president of regulatory and technical affairs, told FDA the industry needed more time “to develop a resolution that will account for the numerous different co-manufacturing situations used by the food industry.”

She argued in a letter to FDA that the situation with co-manufacturers poses a unique regulatory dynamic.

“GMA believes it is appropriate to treat this situation the same way as when using a consultant – so that any of the supply-chain program requirements can be performed by the brand owner on the co-manufacturer’s behalf; except that the co-manufacturer is always responsible for following written procedures for receiving raw materials and other ingredients, and documenting use of the procedures. GMA has recommendations to share with FDA regarding the types of actions the co-manufacturer should take to obtain assurance of the brand owner’s performance of supply-chain program activities,” she said.

NCA said the supplier verification provisions pose another challenge in co-manufacturing situations in terms of resources.

“Some companies have indicated that they do not have enough personnel to manage the flow of supply-chain program information from the brand owner to their multiple co-manufacturers. They would need to incur the expense of hiring additional personnel or reassign their resources away from other supply-chain program activities (e.g., performing on-site supplier audits) to meet this burden, with no incremental food safety benefit,” wrote Debra Miller, NCA’s senior vice president, scientific and regulatory affairs, in an Oct. 16 letter to FDA.

In the meantime, FDA said it plans to announce the enforcement discretion policy in the Federal Register and urged co-manufacturers to continue complying with all other requirements of the Federal Food, Drug, and Cosmetic Act (FDCA).

 

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