FDA Extends Deadline for Supply-Chain Approval

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With the clock ticking toward the implementation of its new supply-chain rules, the FDA announced it is extending its deadline for food producers to implement supply-chain control programs to approve hazard-control systems in place with their ingredients suppliers.

Under the Food Safety Modernization Act (FSMA), food producers will become responsible for abiding by a series of supply-chain rules (located in the Code of Federal Regulations, Title 21, Subpart G). These rules require producers that receive foods and food ingredients from other suppliers (called “co-manufacturers”) keep track of their suppliers’ compliance histories, and only work with suppliers that consistently meet U.S. food-safety standards.

In November 2017, the FDA announced an initial enforcement discretion policy for the new rules. That policy was to last two years, until November 6, 2019, after which producers were expected to be compliant with the new guidelines.

“The complexity of the supply chain and the number of suppliers that manufacturers have, including facilities that manufacture under a brand name (i.e. co-manufacturing), necessitated that food companies were given additional time to adjust specifications and contract details to help facilitate compliance with the rule,” Adrienne Seiling, vice president of strategic communications for the American Frozen Food Institute (AFFI), told Food Quality & Safety.

Some producers complained the demands of the new supplier-verification rules might force them to breach confidentiality agreements by requesting that ingredients manufacturers disclose specific processing details that might otherwise be considered trade secrets. In a letter to the FDA, signatories from 12 food industry associations explained the series of challenges the rule presents: beyond the non-disclosure/confidentiality elements, producers are bound by a series of other contractual demands the associations argued the FSMA would force them to breach. The industry associations also argued that verifying all suppliers would require companies to hire more staff than they could afford.

“We commend FDA’s 2017 decision to provide industry with an additional two years to implement the Preventive Controls supply-chain program requirements in certain situations involving contract manufacturing,” wrote the signatories. “However, even with this additional time, there remain numerous compliance hurdles that have not been resolved. An extension of the compliance date will allow time for industry and FDA to develop a long-term resolution for this issue.”

In a statement, the AFFI specified they “requested an extension to the enforcement discretion to allow for further consultation between FDA and industry to resolve these compliance challenges.”

On the day that discretion policy was to end, the FDA announced its decision to continue its enforcement discretion policy in reflection of the challenges industry faces in becoming FSMA compliant on these issues. The FDA will soon publish a notice in the Federal Register explaining the terms of the enforcement discretion policy extension, but no new compliance deadline has been set.