The FDA is out with “final guidance” for industry and agency staff for the release of retailers that receive recalled foods so they might be more easily identified by consumers.
Current FDA policy prohibits the release of such retailer lists to protect the disclosure of “confidential” business ties. USDA’s Food Safety and Inspection Service (FSIS) routinely releases retail lists and has done so since 2007 when Dr. Richard Raymond was Under Secretary for Food Safety during the Bush Administration.
FDA Friday announced the availability of final guidance entitled “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and FDA Staff.”
FDA says it intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls),
FDA may also publicize retail consignee lists for other food recalls as described in the guidance. FDA says it’s goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.
The guidance for industry and FDA staff describes how and when FDA intends to collect, compile, and publicize lists of retail consignees that may have received recalled foods. FDA’s goal is to publicize retail consignee lists for these food recalls, especially those that are likely to be classified as Class I recalls, providing this additional information will be of the most useful to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.
In the Federal Register of September 27, 2018 (83 FR 48825), FDA announced a draft guidance for industry and FDA staff entitled “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls” and gave interested parties an opportunity to submit comments by November 26, 2018, for us to consider before beginning work on the final version of the guidance.
FDA reviewed comments received and, where appropriate, made changes to the guidance based on these comments. The changes include a change to footnote seven of the guidance regarding restaurants, a statement that FDA intends to update the retail consignee lists as the information available to FDA develops, the removal of an example of food that may fit the criteria described in the guidance, and other non-substantive edits.
The guidance announced in this notice finalizes the draft guidance dated September 2018.
This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents FDA’s current thinking regarding publicizing lists of retail consignees to effectuate certain food recalls.
Persons with access to the internet may obtain guidance at either
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