- “STOP Foodborne Illness,” a non-profit organization, petitioned FDA last month to adopt a policy of publicly disclosing the names of all companies associated with foodborne illness outbreaks, whether or not there is a related recall.
- FDA has long viewed certain business relationships, such as raw material supplier lists, finished product customer lists, and trace-back information as confidential commercial information (CCI), protected from public disclosure. The petition argues that FDA incorrectly classifies company names as CCI under the Trade Secrets Act. The Trade Secrets Act permits disclosure of CCI when “provided by law” (18 USC 1905). FDA considers this requirement met in a recall situation based on 21 CFR 20.91, which permits the use of non-public information to the extent necessary to effectuate an enforcement action.
- The petition requests that FDA change its interpretation of CCI to exclude company names “through an agency statement or memorandum.” In the alternative, the petition requests that the agency either:
- Disclose company names in recall situations by relying on its authority to “protect the public by ensuring that foods are safe” (21 USC 393(b)(2)(A)).
- Revise the language in 21 CFR 20.91 to permit the disclosure of company names in all outbreak situations. The petition disfavors this latter approach because it would require rulemaking.
