By Charles Breen, Independent Advisor for FSMA
In an effort at greater transparency as well as consumer safety, FDA issued Draft Guidance this month proposing how and when FDA would publicize the identities of retail consignees that may have received recalled human or animal foods. This release of retailer information would only occur in cases where a food recall presents a serious adverse health consequence or death to humans or animals (SAHCODA), i.e., Class I recalls. The intention is to provide information to consumers to take a closer look at their purchases should they recognize that they shop at a particular location.
There is typically no single source that FDA can access to readily obtain a list of retail consignees of a recalled food product, therefore the decision to list retail consignees requires information obtained from multiple entities throughout a supply chain, including the recalling firm and its intermediate distributors – no small task. In addition, FDA may not be able to fully verify the accuracy or completeness of the information it receives from recalling firms or distributors so its available information may be over and under-inclusive In other words, FDA may not identify every retailer who received recalled product, and might inadvertently identify retailers who, in fact, did not receive the recalled item.
Currently, FDA routinely provides labeling information, product descriptions, lot numbers, and photographs, and if available to FDA – geographic or retail-related distribution information. It also lists all FDA-regulated recalls in the FDA Enforcement Report.
As noted in the Draft Guidance, the release of retailer information is authorized under Section 206 of the 2011 FDA Food Safety Modernization Act, ‘which directs the Agency, in conducting recalls under the section 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 shall consider providing such a list to the public,” when FDA considers the release to be appropriate (21 U.S.C. § 350l(g)(2)). The Department of Agriculture (USDA) policy is to make publicly available the names and locations of retail consignees of recalled meat or poultry products that USDA compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death (Class I recalls). 9 CFR 390.10.’
FDA will consider two specific criteria that may warrant the release of retail consignee information, including when a recalled food is related to a foodborne illness outbreak, and where the information would be most useful to consumers. Examples of such foods are fruits, nuts, vegetables, and rawhide chews sold in bulk bins with no UPC or barcode, raw meat or deli products, or when the food product lacks a lot number, or other identifiers, which consumers can use to readily identify the product as one being recalled.
While there is some understandable concern regarding the publication of consignees and suppliers due to possible disclosure of confidential information, the Agency assures all that it will consider carefully the release of any additional retailer information, weighing risks to consumer health and safety. While FSMA has many facets that aim to proactively improve our food safety, no system is completely fool-proof. In cases where FDA and food manufacturer efforts at preventive controls fail, the additional release, as necessary of retailer information included in a recall will help to ensure the public has a greater awareness of contamination and can avoid the consumption of such products.