Two Citizen Petitions Ask FDA to Name Outbreak Firms — DOJ Says It Can
Marler's petitions ask FDA to name confirmed outbreak firms and publish Class I recall consignee lists. A DOJ opinion dated October 26, 2026 says the agency has authority to do it.
Food safety lawyer Bill Marler has filed two citizen petitions asking FDA to name the firms behind confirmed outbreaks and publish retail consignee lists in every Class I recall — after a Justice Department opinion dated October 26, 2026 told HHS the agency has the authority to do both.
The petitions arrive after FDA's own record of withholding. Food Safety News reported that FDA withheld company names in its mango outbreak summary. Food Safety Magazine described a fatal Listeria outbreak summary in which FDA redacted all key details, down to the patients' home states. When Stop Foodborne Illness petitioned FDA in February 2026 to stop treating company names as confidential, FDA answered that the Trade Secrets Act protected them.
That legal defense now has a counter. The Office of Legal Counsel agreed current FDA regulations generally bar disclosure, but concluded that Section 705(b) of the Food, Drug, and Cosmetic Act, combined with rulemaking authority under Section 701(a), lets FDA amend its rules to authorize naming firms where there is imminent danger to health or gross deception of the consumer. Disclosure under such a rule, OLC said, would not violate the Trade Secrets Act.
What do the petitions actually ask for?
- Outbreak firm disclosure. FDA would amend regulations to state that a firm's name and location are not confidential commercial information when epidemiologic evidence implicates a food and traceback or laboratory evidence, including whole genome sequencing, identifies the firm as the source. The rule covers growers, processors and distributors, with or without a recall.
- Recall consignee lists. FDA would publish the retail stores that received a recalled food in every Class I recall, and classify and publish every food recall's classification within a set number of days.
Marler draws a deliberate line. He does not ask FDA to publish suspects. He asks it to name the firm its own investigation confirmed — the same evidence FDA uses to close a case.
The 2024 romaine outbreak is his central exhibit. E. coli O157:H7 in romaine sickened 89 people across 15 states, hospitalized 36, caused seven cases of hemolytic uremic syndrome and killed one person. FDA closed the investigation naming only the commodity. The traceback summary, later released without redactions after supply chain firms consented, showed the investigation had converged on one processor and one grower. The public learned the names through records requests more than a year later, after the season had passed.
Is any of this actually radical?
The record suggests not:
- USDA's FSIS has published retail consignee lists in Class I meat and poultry recalls under a final rule adopted in July 2008. The beef and poultry industries survived.
- The Food Safety Modernization Act of 2011 told FDA to consider USDA's consignee policy. FDA wrote guidance saying it would publish lists in some cases.
- FDA has named farms, processors and brands in comparable circumstances at least eight times since 2006.
- In July 2025, FDA published more than 200 drug rejection letters under the banner "FDA Embraces Radical Transparency," and in September said it would release them in real time. The letters contain company names, redacted only for confidential commercial information.
What changed at FDA and HHS?
The petitions target leadership that wrote the transparency commitments itself. FDA's July 9, 2025 letter to industry on recall communications stated that "radical transparency in food safety and nutrition actions is key to reducing foodborne illness and chronic disease." On September 24, 2025, FDA's food program launched Executive Incident Summary abstracts for closed outbreak investigations. Kyle Diamantas, then Deputy Commissioner for Food, ran that program and now serves as acting commissioner. Marty Makary resigned in May 2026. President Trump nominated Dr. Heidi Overton as commissioner in August 2026.
Marler leans on Section 705(b)'s second ground: gross deception. FDA closed a 50-person E. coli O157:H7 outbreak linked to chicken wraps on October 28 without naming the brand, maker or states, arguing more detail would not have given consumers a preventive action. The public learned the brand from a lawsuit and a newspaper. Marler, who represents plaintiffs in that outbreak, argues the consumer is also the Walmart or school district buyer who cannot weigh a supplier's record the agency has confirmed.
The industry case rests on a number. Numerator data reported by Grocery Dive showed 6.5 million households stopped buying salad mixes and kits in a single month during this summer's Cyclospora outbreak. Anonymity spread one firm's harm across an entire category. In 2008, tomato growers lost a season to a Salmonella outbreak that turned out to be peppers.
The OLC opinion carries one limit: a 705(b) rule authorizing disclosure after an outbreak has ended would likely conflict with the imminent-danger ground. OLC left open whether that timing limit reaches the deception ground, and Marler says the petitions acknowledge the gap. They also argue a firm's name is not confidential commercial information in the first place — a second, independent path.
No new statute or appropriation is required. FDA can write the rule itself. Whether Diamantas or a confirmed Overton picks it up will show whether the agency's written commitments carry operational weight, or whether names keep arriving through court filings and reporters first.
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Market editor covering technology and product news in Restaurant and hotel operations at The Pass Brief.
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