The U.S. Food and Drug Administration (FDA or the agency) has issued a final Guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (Guidance).1 This Guidance provides information on how and when the FDA intends to publicize the identities of retail consignees that may have received recall human or animal foods. The FDA released a draft version of the Guidance in September 2018 as part of a series of actions intended to improve oversight of food safety and the recall process,2 and the final Guidance largely mirrors the draft Guidance, with a few minor changes.3 This memorandum provides a high-level summary of the Guidance.
Background
Publication of the Guidance is one of several policy steps the agency has taken as part of a broader plan to improve oversight of food safety and the recall process. The Guidance also responds to Section 206 of the FDA's Food Safety Modernization Act (FSMA), which directs the agency to “consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall” and to “consider providing such a list to the public.”4
When the FDA Will Publicize Retail Consignees
The agency’s goal is to publicize retail consignee lists for those food recalls, especially those that are likely to be classified as Class I recalls, when providing the information will be of most use to consumers to help them identify recalled food and to determine whether the food is in their possession as effectively and quickly as possible.
The FDA intends to publicize retail consignee lists for food recalls when both of the following criteria are met:
- the food is not easily identified as being subject to a recall from its retail packaging (or lack thereof); and
- the food is likely to be available for consumption (i.e., given its shelf-life or perishability, it may still be in a consumer’s possession).
Examples of foods that may meet both criteria include foods sold directly to consumers with no universal product code (UPC) and/or bar code (e.g., deli cheese, nuts, or pet treats sold in bulk); fresh fruits and vegetables sold individually; or when the food product lacks a lot number, or other identifier.
The FDA will consider publicizing retail consignee lists in other recall situations that do not meet both criteria, including for recalls which may include packaged food, especially when a recalled food is associated with a foodborne illness outbreak.
Although the FDA intends to focus on publicizing retail consignee lists for Class I recalls, the agency may also publicize retail consignee lists for some Class II food recalls, particularly where the FDA has issued a public warning or where there is an association with an outbreak of a foodborne illness. In order to ensure timely dissemination of information, the FDA also may publish retail consignee lists for recalls that have not yet been classified.
The FDA may elect not to publicize the consignee information in cases where doing so would undermine a public warning (e.g., if the FDA has warned the public to avoid a specific food commodity in general, and the recalled food was only sold through a limited number of retail outlets).
Type of Information Published
In terms of specific information that will be included, the agency intends to provide a specific retail store name and its address. However, depending on the nature of the distribution, the FDA may list retail store chains and general geographic locations rather than the locations of specific retail stores (e.g., “all Grocery ABC stores nationwide”). The Guidance clarifies that although it is specific to retail consignees, the agency’s authority is not limited to retail consignees, and can include the disclosure of the names of restaurants and similar entities, where appropriate. The Guidance also explains that the FDA intends to provide updates to the information “as available and needed.”
Limitations of the Retail Consignee List
The agency also recognizes there will be limitations to accessing and compiling the consignee lists (e.g., where they cannot fully verify the accuracy or completeness of the information it receives from recalling firms or distributors, lists may not include all retail locations that have received the food, or lists may include retail locations that did not receive the food). In publishing the lists, the agency will identify these limitations, and will direct consumers to other identifying information in addition to the list to identify recalled product.
How Publicized
The FDA will post lists of retail consignees associated with a specific recall on its website, and may publicize this information in other ways consistent with how the FDA currently makes recall information public. In some limited circumstances, a recalling firm may be able to identify all the retail consignees itself because it provided the recalled food directly to the retail consignees. In these limited cases, the FDA may give the recalling firm the first opportunity to prepare and issue publicly its list of retail consignees that received the recalled food, if the firm’s release of this information would be timely and complete.
Authority to Publish Retail Consignee Lists
The FDA has authority under 21 C.F.R. § 20.91 to disclose confidential commercial information that otherwise would be exempt from public disclosure to the extent necessary to effectuate a recall. Accordingly, when relying on this authority, the FDA will first decide that there is a “recall” as defined under 21 C.F.R. § 7.3(g), but may not have determined the classification of the recall.
We will continue to monitor developments concerning public availability of retailer and other information released during recalls.
References
1 Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (Nov. 2020), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-lists-retail-consignees-effectuate-certain-human-and-animal-food-recalls.
2 See HL Memo - FDA Issues Draft Guidance on Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls (Oct. 2018), available at https://www.hlfoodlaw.com/2018/10/fda-issues-draft-guidance-publishing-retail-consignees-lists-effectuate-certain-human-animal-food-recalls/.
3 The changes made in the Final Guidance include a statement regarding FDA’s authority to disclose the names of restaurants and similar entities, where appropriate; a statement that FDA intends to update the retail consignee lists as the information available to FDA develops; and the removal of rawhide chews from the list of foods that may potentially meet the criteria for the release of consignee lists, among other non-substantive edits.
4 21 U.S.C. § 350l(g)(2).
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