FDA Proposed Rule Includes “Food Traceability List”

FDA proposes new traceability regulations ( FDA )

The U.S. Food and Drug Administration has proposed a new rule that would establish a list of foods that would require additional recordkeeping beyond current regulations.

The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” is a component of the FDA’s New Era of Smarter Food Safety Blueprint. If finalized, the new proposal would standardize the data elements and information that companies must establish and maintain, and the information they would be required to send to the next entity in the supply chain to facilitate traceability.

Deputy Commissioner for Food Policy and Response at FDA Frank Yiannas said the proposal for traceability was a critical step forward in the agency’s efforts to bring about farm-to-table traceability in the US food supply. The rule also would help the agency rapidly identify recipients of those foods to prevent or mitigate foodborne illness outbreaks.

FDA published a draft “Food Traceability List,” which describes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more.

“The FDA has proposed a new rule that lays the foundation for the end-to-end food traceability across the food industry that we’ll be working toward over the next decade as part of the New Era of Smarter Food Safety initiative,” Yiannas said. “When we say traceability, what we are really talking about is the ability to track a food at every step of the supply chain. While limited to certain foods, this proposed rule would create a first-of-its-kind standardized approach to traceability recordkeeping, paving the way for industry to adopt and leverage more digital, tech-enabled traceability systems both in the near term and the future.”

The proposed rule will be available for public comment for 120 days following publication in the Federal Register.

The Food Traceability List (FTL) identifies the foods for which the additional traceability records described in the proposed rule would be required. FDA identified foods to include on the FTL based on seven criteria:

  • Frequency of outbreaks and occurrences of illnesses;
  • Severity of illnesses;
  • Likelihood of contamination;
  • The potential for pathogen growth, with consideration of shelf life;
  • Manufacturing process contamination probability and industry-wide intervention;
  • Consumption rate and amount consumed; and
  • Cost of illness

The proposed Foods Traceability List includes:

  • Cheeses, other than hard cheeses
  • Shell eggs
  • Nut butter
  • Cucumbers
  • Herbs (fresh)
  • Leafy greens
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fruits and vegetables (fresh cut)
  • Finfish
  • Crustaceans
  • Mollusks and bivalves
  • Ready-to-eat deli salads