By Elizabeth M. Dries, J.D.
The FDA will begin publicizing retail consignee lists for food recalls when providing additional information that will be used by consumers to help them identify recalled food, and to determine whether that food is in their possession as effectively and quickly as possible. The FDA’s draft guidance entitled "Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls" establishes guidance for industry and the FDA on how the FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods (Notice, 83 FR48825, September 27, 2018).
Retail consignee. A retail consignee refers to retail establishments that sell food products directly to consumers that are meant to be consumed away from the establishment. This includes retail establishments that sell to consumers physically present in the store like grocery stores and convenience stores, and retail establishments that receive orders through any means (by phone, internet or catalog). The FDA does not consider most restaurants retail consignees. The FDA intends to focus on recalls where there is a serious adverse health consequences to or death to humans or animals (Class I recalls), and where providing such information is needed to help consumers identify recalled food. However, the FDA may also publicize retail consignee lists for some Class II food recalls when the FDA has issued a public warning or where there is an association with an outbreak of a foodborne illness. Furthermore, The FDA may disclose this information in cases of recalls that have not yet been classified as Class I or Class II.
Criteria. The FDA will publicize retail consignee lists for food recalls when two criteria are met: (1) the food is not easily identified as being subject to a recall from its retail packaging (or lack thereof; and (2) the food is likely to be available for consumption (given its shelf-life or perishability). Examples of such foods may include foods sold directly to consumers with no universal product code and fresh fruits and vegetables sold individually; or when the product lacks a lot number or other identifier. The FDA will also consider publicizing retail consignee lists in other recall situations that do not meet both these criteria when a recalled food is associated with a foodborne illness outbreak.
The FDA intends to provide the specific retail store name and address, and may even list retail store chains and geographic locations. The FDA will post lists of retail consignees associated with a specific recall on the FDA website and in other ways consistent with how the FDA makes recall information public. In some circumstances a recalling firm may be able to identify consignees and the FDA may give the recalling firm the first opportunity to publicly issue its list of retail consignees that received recalled food.
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