FDA Petitioned to Stop Protecting Identity of Companies Involved in Foodborne Illness Outbreaks
Stop Foodborne Illness has submitted a petition to the U.S. Food and Drug Administration (FDA) urging the agency to adopt a policy of publicly disclosing the names of all companies associated with foodborne illness outbreaks, regardless of whether there is a related recall.
Legal Basis for Disclosing Companies Involved in Outbreaks
At present, FDA protects the identity of these companies from disclosure because it considers a company name to be “confidential commercial information” (CCI) per the Trade Secrets Act—an interpretation which the petition says is inconsistent with applicable statutory language and case law.
The Trade Secrets Act defines CCI as information “which concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof.”
Additionally, legal precedent (Food Mktg. Inst. v. Argus Leader Media) defines “confidential” company information as that which is “customarily kept private, or at least closely held, by the person imparting it,” and the company must have received “some assurance that [the information] would remain secret.”
Granting Petition Would Display ‘Radical Transparency’
The petition argues that changing FDA’s position that a company name is CCI would be easily achieved through an agency statement or memorandum announcing a change in its interpretation.
However, if the agency decides to continue to treat a company name as CCI, then the petition asks that FDA still disclose the names of all companies linked to an outbreak based either on its responsibility to ensure safe food under the Federal Food Drug and Cosmetic Act (FD&CA) or by revising the language in the Code of Federal Regulations (21 CFR §20.91) to allow broader disclosure of the brand name of any company linked to the outbreak.
“Such action is consistent with FDA’s mission to protect public health, and with [the Presidential] Administration’s commitment to ‘radical transparency,’” says the petition.
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Not Sharing Company Names Disproportionately Affects Produce Outbreaks
According to the petition, publicizing the name of every company involved in a foodborne illness outbreak could 1) prompt some consumers who ate affected product but did not seek medical attention or report their illnesses to the health department to do so, 2) alert people who may still have the food product in their homes not to eat it and thereby prevent additional illnesses, and 3) incentivize companies whose names have been publicly disclosed to redouble their efforts related to food safety.
Furthermore, FDA’s policy of limiting disclosure of company names to only outbreaks involving recalls disproportionately affects outbreaks involving fresh produce, per the petition. Because produce is perishable, recalls often occur less frequently for fresh fruits and vegetables than for processed foods, which have longer shelf lives. At the same time, fresh produce is responsible for a significant percentage of foodborne illness outbreaks.
The petition provides an example of a multistate outbreak at the end of 2024 caused by Escherichia coli-contaminated romaine lettuce distributed to schools, restaurants, catered events, and retail. A total of 89 people were sickened, seven people developed hemolytic uremic syndrome, and one died. Despite FDA identifying the company that sold the lettuce via whole genome sequencing (WGS), the agency did not disclose its name because the outbreak did not have an associated ongoing recall or the product was no longer being sold.
