Attorney General’s Office: FDA Can Amend Regulations to Disclose Company Information During Foodborne Illness Outbreaks
On October 26, the U.S. Attorney General’s Office of Legal Counsel published an opinion signed by William D. Hyde Jr., Deputy Assistant Attorney General, concluding that the U.S. Food and Drug Administration (FDA) has the authority to amend its regulations to disclose information about companies involved in foodborne illness outbreaks.
At present, standard FDA practice is to protect the identity of companies associated with foodborne illness outbreaks when there is not an active recall, because it considers a company name to be “confidential commercial information” (CCI) per the Trade Secrets Act. For example, many of the agency’s Executive Incident Summaries (EISs) for closed outbreak investigations are heavily redacted. FDA has received criticism for this practice from consumer protection stakeholders, and was petitioned in February by Stop Foodborne Illness to disclose the identities of all firms involved in foodborne illness outbreaks.
Mr. Hyde’s opinion pointed out that, under the Code of Federal Regulations (21 CFR §20.91), FDA may disclose supply chain information when “necessary to effectuate” an administrative or court enforcement action such as a recall. While the opinion agreed that supply chain information often does not qualify for disclosure under 21 CFR §20.91 for various reasons (e.g., whether the food is not available for consumption, the ease of identifying the food from its retail packaging, whether distribution was limited, whether consumers are likely to have thrown away product labeling), Mr. Hyde also called this analysis “arduous” and “onerous,” and said it is not required by the Federal Food, Drug, and Cosmetic Act (FD&C).
While Mr. Hyde acknowledged that “the Trade Secrets Act largely prevents FDA from disclosing supply chain information,” liability under the act does not “attach for the disclosure of protected information when the disclosure is ‘authorized by law” and that “properly promulgated, substantive agency regulations” can serve as the requisite authorization. Therefore, “FDA has authority to amend its regulations to allow broader disclosure, should it choose to do so in the future.”
The opinion concluded, “FDA has statutory authority to amend its regulations to allow broader disclosure of supply chain information in situations involving imminent danger to health, or gross deception of the consumer.”
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