Justice Department Says FDA Can Rewrite Its Rules to Name Companies Behind Food Outbreaks
A Justice Department legal opinion says FDA's own regulations keep supply chain names secret during outbreaks and recalls, and that the agency has the authority to change them.
When people get sick from contaminated food, FDA often doesn’t say which companies made or sold it. A new Justice Department legal opinion says the agency’s own regulations are the reason, and that FDA has the power to change them.
TLDR
- The Justice Department’s Office of Legal Counsel issued the opinion on October 26, in response to a question from the Acting General Counsel of the Department of Health and Human Services (HHS).
- It concludes that current FDA rules generally do not allow the agency to disclose supply chain information, so the Trade Secrets Act blocks it.
- It also concludes that FDA can amend those rules to allow disclosure “in situations involving imminent danger to health or gross deception of the consumer.”
- The opinion doesn’t change anything on its own. FDA would have to write new regulations first.
What the Opinion Says
The Trade Secrets Act, which dates to 1864, bars federal employees from disclosing business information the government collects unless the disclosure is “authorized by law.” FDA treats supply chain information, such as which suppliers, distributors and stores handled a product, as confidential commercial information that is generally “not available for public disclosure” under its regulations.
Those regulations have a few exceptions, including information already made public lawfully, a court order, and disclosure “necessary to effectuate” an enforcement action such as a recall. FDA can also disclose information with a company’s consent. But the opinion calls the enforcement exception “exceedingly narrow in practice,” adding: “FDA’s hands are tied before a recall is officially initiated.”
The opinion, signed by Deputy Assistant Attorney General William D. Hyde Jr., concludes that a federal law, 21 U.S.C. 375(b), lets the HHS Secretary and his delegees amend the rules to allow broader disclosure when there is imminent danger to health or gross deception of the consumer. Under properly issued regulations, it says, such disclosure “would not violate the Trade Secrets Act.”
The Limits
The opinion sets clear boundaries. A regulation allowing disclosure after an outbreak has already ended “would likely be inconsistent” with the law “and hence unlawful,” it says, because the authority is tied to imminent danger. The statute leaves the judgment of when imminent danger exists to the FDA Commissioner.
Why Advocates Are Watching
Food safety attorney Bill Marler, who has petitioned FDA to name firms tied to outbreaks and to publish the stores that received recalled food, wrote on his blog that the opinion confirms “its own regulations are what keep outbreak names secret.” He said he is revising both petitions to ask FDA for a rule allowing firms to be named while an outbreak is open.
Marler pointed to recent cases. In the E. coli outbreak linked to Trader Joe’s Tarragon Chicken Salad Wraps, which has sickened about 50 people, the public learned the brand from a lawsuit and a newspaper, not from federal agencies. He also cited a Salmonella Newport outbreak that FDA closed at 119 cases on October 21 without naming a food.
Why It Matters
Shoppers can’t check their refrigerators for a product no one will name. The opinion settles whether FDA can change its rules, but it does not say whether FDA will. Any change would require FDA to propose and finalize new regulations, a process that includes public comment.
Sources: U.S. Department of Justice, Office of Legal Counsel; Food Safety News; Marler Blog.