FDA Officially Announces FSMA 204 Delay

The agency officially says this extension does not amend the final rule requirements but allows all stakeholders to fully prepare for implementation.

FSMA 2024, Food Safety Modernization Act
(The Packer)

In a news release, the U.S. Food and Drug Administration said it will propose to extend the compliance date for the Food Traceability Rule, known as FSMA 204, by 30 months.

FSMA 204 establishes additional traceability record-keeping requirements for entities that grow, process, pack or hold foods on this list. FDA says this requires a higher degree of coordination between members of the fresh produce and food industry.

The extension gives covered entitles — which include cucumbers, fresh-cut leafy greens, fresh leafy greens, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, ready-to-eat salads and more — more time to ensure complete coordination across the supply chain.

The agency had announced its intentions to delay compliance back in March.

And in its latest announcement, the agency reiterated this compliance date does not change the requirements of this final rule.

“The proposed compliance date extension does not amend, nor do we intend to amend, the requirements of the final rule, which will improve food safety and protect public health,” the agency said in its update. “The proposal is designed to afford covered entities the additional time necessary to ensure coordination between supply chain partners in order to fully implement the final rule’s requirements.”

The agency cited challenges to meeting the original January 2026 timeline for growers as the need to delay this compliance date.

“The FDA is aware that even among those few entities who are well positioned to meet the final rule’s requirements by January 2026, there are challenges to meeting this timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who might not be similarly situated,” the agency said.

On the agency’s Food Traceability Rule webpage, the following is now available:

  • New FAQs
  • New examples of traceability plans for food processors, distribution centers and aquaculture farms and facilities
  • New supply chain examples for produce, dual jurisdiction facilities and more
  • An at-a-glance document on the rule
  • Translations of the above documents into six additional languages (Spanish, French, Chinese, Thai, Vietnamese, Indonesian)
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