Justice Department OLC Opinion of October 26: FDA's Own Regulations 'Largely Prevent' Naming Supply Chain Firms in Foodborne Outbreaks, and a New Rule Could Fix It
On October 26, the Justice Department's Office of Legal Counsel (OLC) issued an eight-page opinion to the Acting General Counsel of the Department of Health and Human Services (HHS), titled Public Disclosure of Supply Chain Information in Foodborne Illness Outbreaks and Recalls. HHS had asked a simple question: is the Food and Drug Administration (FDA) authorized by law to tell the public who is in the supply chain of a food that is making people sick? The opinion concludes that what mainly blocks FDA is FDA's own regulations, not the statute; that FDA can amend those regulations to authorize disclosure; and that it has not done so.
First, the opinion explains that the Trade Secrets Act bars federal employees from disclosing confidential business information only when the disclosure is not authorized by law, and a properly issued regulation is itself such authorization. FDA's regulations, at 21 CFR 20.61, treat the names and locations of firms in a supply chain as confidential commercial information and wall that information off. Given those regulations, the opinion concludes, the Trade Secrets Act largely prevents FDA from disclosing supply chain information.
Second, the exception FDA leans on, 21 CFR 20.91, which permits disclosure to the extent necessary to carry out an enforcement action such as a recall, is exceedingly narrow in practice, the opinion says: it applies only when there is an actual enforcement action, and in the opinion's words, FDA's hands are tied before a recall is officially initiated; by the time FDA collects the information, it is often no longer necessary. The opinion also says the statute nowhere requires the case-by-case analysis in FDA's 2020 consignee guidance, which it calls arduous.
Third, FDA can fix it. Section 705(b) of the Food, Drug, and Cosmetic Act lets FDA disseminate information regarding food in situations involving, in the Commissioner's opinion, imminent danger to health or gross deception of the consumer. Combined with FDA's general rulemaking authority, the opinion concludes, that provision lets FDA amend its regulations to authorize disclosure of supply chain information; disclosure under such a rule would be authorized by law and would not violate the Trade Secrets Act. The opinion adds that this would hardly be a transformative expansion of FDA's power, and that neither the FOIA exemption for commercial information nor the Act's own trade secret provision stands in the way. It also draws a limit: a regulation purporting to authorize disclosure after an outbreak has already ended would likely be inconsistent with section 705(b), because the imminent-danger authority is a tool for an open outbreak. In a footnote, the opinion questions whether the identity of a supply chain partner is even the kind of information the Trade Secrets Act protects.
The opinion bears on a live investigation: food safety attorney Bill Marler, who published the full text of the opinion on October 26, wrote that FDA and the USDA's Food Safety and Inspection Service are jointly investigating a chicken wrap E. coli O157:H7 outbreak, reference #1421, with 50 people sick, and that the public learned the wraps were Trader Joe's Tarragon Chicken Salad Wraps from a lawsuit his firm filed and from a newspaper, not from either agency. Marler said he has revised two petitions in light of the opinion: one asking FDA to adopt a new disclosure rule along the lines the opinion describes, and one asking FDA to publish consignee lists when every Class I recall is announced; both now also copy the HHS Acting General Counsel, who requested the opinion. FDA had told the organization Stop Foodborne Illness in July that its pending petition on this question raised complex issues.
Source: GSM · USA (original Chinese edition)
Photo: 华盛顿司法部总部（Robert F. Kennedy 大楼）外墙标识，G. Edward Johnson 摄，CC BY，Wikimedia Commons
