The FDA may begin releasing lists of retailers that receive recalled food so consumers can more easily identify it. Agency policy has prohibited the release of such information, citing considerations for “confidential” business relationships.
Consumers, businesses, and others can comment on a draft of procedures for industry and the agency, according to a statement issued today by Scott Gottlieb, commissioner of the Food and Drug Administration. The draft says retailers’ names and locations would be released to the public only under certain circumstances, a continuation of the agency’s practice of protecting Confidential Corporate Information (CCI).
“FDA will primarily focus on those 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health consequences or death to humans or animals, which are also referred to as Class I recalls,” according to the draft guidance.
“ … In addition, for a variety of reasons, FDA may not be able to fully verify the accuracy or completeness of the information it receives from recalling firms or distributors. In such cases, the information available to FDA about retail consignees may be both over and under-inclusive, in that it may not include all retail locations that have received the food or may include retail locations that did not receive the food.”
Both Gottlieb’s statement and the draft of the new guidance say the release of retailer lists will not be automatic. The FDA will give higher priority to food recalls that are associated with foodborne illnesses, but even then the release of the business-to-business information may not be made public.
The determining factors the FDA would consider before making retailer lists available to the public include, for packaged foods, would be whether the food was distributed in a particular geographic region or through a particular online retailer if the agency.
For fresh produce that is sold individually, certain perishable foods, some foods that are sold in bulk bins, and foods without UPC numbers and/or bar codes that is sold directly to consumers — such as deli cheese — or “or when the food product lacks a lot number, or other identifiers, which consumers can use to readily identify the product as one subject to the recall.”
The proposed change is not a perfect solution, but “in government policy, you don’t want to make perfect the enemy of the good,” said Bill Marler, a Seattle attorney who represents victims of food poisoning. He worked out settlements for victims of the 1993 Jack in the Box E. coli outbreak, and subsequent outbreaks involving a variety of packaged foods and fresh produce.
Marler has been advocating for the release of retailer lists for years.
“I think it’s fair to say that I’ve been a regular critic of FDA’s failure to be transparent when it comes to recalled products,” Marler said today. “At least preliminarily, I’m very supportive of what Commissioner Gottlieb is doing.”
Pointing to the shift in policy in 2007 by the USDA’s Food Safety and Inspection Service (FSIS) to provide the public with retailer lists was a good move, and had served consumers well, Marler said.
“I hope the retailers will be supportive of FDA’s move. The pushback that FSIS got was from retailers.”
The deadly E. coli outbreak earlier this year connected to romaine lettuce — and the difficulties the FDA and state agencies had with the traceback during the outbreak investigation — is an example of how this proposed change in policy should help, according to Marler, who has filed civil cases for a number of the outbreak victims and their families.
In the romaine situation, the fact that the commodity is usually sold without packaging or any identifying information made it virtually impossible for consumers to know which romaine was or was not implicated, he said. Marler said he is pleasantly surprised by Gottlieb’s announcement today saying it is a step in the right direction.
The FDA’s draft guidance includes criteria it will use in determining when to release retailer lists to the public.
“Specifically, FDA intends to publicize retail consignee lists for such food recalls when both of the following 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 (i.e., given its shelf-life or perishability, it may still be in a consumer’s possession).
Examples of such foods may include foods sold directly to consumers with no universal product code (UPC) and/or barcode (e.g., deli cheese, nuts, rawhide chews, or pet treats sold in bulk); and fresh fruits and vegetables sold individually; or when the food product lacks a lot number, or other identifiers, which consumers can use to readily identify the product as one subject to the recall.”
The agency will also publish retailer lists when situations do not meet the criteria on a case-by-case basis when the public could benefit from the information.
The comment period on the proposed policy change and guidance is open for 60 days. Anyone who wants to submit comments and suggestion can submit them electronically at: https://www.regulations.gov.
To submit written comments, send mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-1752.
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