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Issue Number: Council I 018

Title

Report - Recall Evaluation Committee

Issue you would like the Conference to consider

The Food Recall Evaluation Committee (REC) was tasked with the evaluation of current policy and practice of food recalls of the U.S. Food and Drug Administration and the U.S. Department of Agriculture, with the goal of providing feedback and recommendations that these agencies could consider in improving food recalls and recoveries.

The committee met via a series of webinars for the past 18 months. Membership included a diverse cross-structure of industry and regulators as well as academia and public interest representatives.

The committee believes we have reached consensus on the items included herein and detailed in the attached reports.

Public Health Significance

Beyond question, the current system of recalling food products in the United States in case of real or purported health or quality issues is flawed. While part of the problem resides in the sheer complexity of the global food production and distribution system, the process of recalling a product is difficult for industry and incomprehensible to the general public. While new (pending) food safety legislation will address a few of the problems, there remains the need to overhaul and clarify the current recall classification and notification process.

Consider:

  • FDA is guided by Ch. 7 of their 2009 Regulatory Procedures Manual/ 21CFR
  • Recalling Firm is guided by "GUIDANCE FOR INDUSTRY" document by FDA
  • Firms affected by the recall throughout the complex food system (distributers, sub-producers, brokers) have no official FDA guidance
  • There is no time limit for executing a Class I Recall, or any other Class
  • There are no minimum requirements for the information required in a recall notice
  • There is no consideration of cost to benefit
  • Current Classification system is ambiguous and confusing


Recommended Solution: The Conference recommends...

  • acknowledgement of the Food Recall Evaluation Committee (REC) report and attachments,
  • thanking the Committee members for their efforts, and
  • disbanding the Committee as the charges are completed.

Attachments

Word File