Earlier this month I posted that I had drafted two citizen petitions to the FDA and asked anyone who wanted a copy to email me. The first asks the agency to establish by rule that the identity of a firm implicated in a foodborne illness outbreak is not confidential commercial information, and to name implicated growers, processors and distributors whether there is a recall. The second asks the agency to publish retail consignee lists in every Class I food recall, as the USDA has done for meat and poultry since 2008, and to classify every food recall promptly.
Many of you asked for copies, read dozens of pages of footnotes, and sent back thoughtful, sometimes pointed, suggestions. Thank you. The drafts are sharper, fairer to the firms that would be named, and harder to dodge because of it.
The Trader Joe’s wraps, in one paragraph
On September 23, the FDA posted an E. coli O157:H7 outbreak on its investigations table with 25 sick and the vehicle listed as a “multi-ingredient wrap with chicken (suspect).” No brand, no retailer, no manufacturer, no states, no recall. By then the FDA had already told Trader Joe’s there might be a “possible issue,” and Trader Joe’s had already pulled its Tarragon Chicken Salad Wraps from shelves in nine states. On October 15, with 50 sick, we filed Gottlieb and Bright v. Trader Joe’s Company, and the name entered the public record for the first time – in a court filing. On October 23, FSIS confirmed the link – in an email to USA TODAY. As of Friday evening, neither agency’s own website named the brand, the maker, the nine states, the hospitalizations or the HUS cases, and there was still no recall and no list of stores.
That is the problem these petitions are written to fix. And it is not unique to Trader Joe’s. Two days before FSIS answered USA TODAY, the FDA closed a 119-person Salmonella Newport outbreak without ever naming a food. In 2013, when Glass Onion Catering’s chicken salads and wraps sickened people who shopped at Trader Joe’s and elsewhere, the agencies named the maker and the products within days.
What the drafts now ask for
The outbreak firm disclosure petition now asks the FDA to write the rule with the confidentiality exemption closed, so that a firm that wants its name withheld has to prove, on the record, that its name is a genuine trade secret or competitively sensitive for some reason other than the outbreak itself. It reaches the whole supply chain – grower, cooler, processor, manufacturer, distributor and retailer – because in many produce outbreaks there is no brand to name. It gives a firm named in error a short notice-and-correction period before publication and a correction published with the same prominence afterward. For open investigations, it asks the agency to publish the case counts, states, onset dates, hospitalizations and HUS cases it already compiles, and once traceback begins, to name the suspect food and, for a multi-ingredient product like a wrap, the ingredient under investigation. And it makes disclosure turn on what happened, not on what the firm calls it: a “proactive removal” of an outbreak food is treated the same as a recall.
The recall consignee petition asks the FDA to turn its 2020 guidance into a binding rule on the FSIS model, to reach restaurants, schools, hospitals and other institutions as well as grocery stores, to classify every recall within ten days, and to confirm that pulling a food identified as the suspected vehicle of an outbreak is a recall, whatever the firm calls it, so that it is classified and its store list is published.
Had those rules been on the books in September, the people who bought Tarragon Chicken Salad Wraps would have learned which product, which retailer and which states from the government, not from a complaint and a newspaper a month later.
One more week
I plan to file both petitions after Friday, October 30. Until then, I would welcome another round. If you have not seen the current drafts, email me at bmarler@marlerclark.com and I will send them. I am especially interested in hearing:
From growers, processors and retailers: is a one-business-day correction window workable, and what would make it fair? How quickly can you produce a consignee list in a Class I recall?
From public health officials: does publishing case counts, states and onset dates during an open investigation help or hinder your interviews and case finding?
From lawyers and academics: what is the strongest Exemption 4 or Trade Secrets Act argument against these requests, and have I answered it?
From everyone: once the petitions are filed and docketed, a short supportive comment does more than you might think. I will post the docket numbers here.
Public health information should not depend on whether someone files a lawsuit, or a reporter has the time to ask. Thank you again for making these petitions better. Let’s make them better still this week.
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