Reading Room Document

The Food and Drug Administration's Discretion to Approve Methods of Detection and to Define the Term "No Residue" Pursuant to the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration has the discretionary authority under the DES proviso to the Delaney Clause of the Federal Food, Drug, and Cosmetic Act to prohibit the use of an additive in animal feed if the FDA concludes that there is no method that can "reliably measure and confirm" whether the additive contains residues of carcinogenic concern at or above the "no residue" level. Where the FDA has already approved a method for detecting the presence of residues of carcinogenic concern, the DES proviso does not require the FDA to revise its regulations to adopt the "best available" such method. The FDA lacks the discretion to determine that an edible tissue contains "no residue" when a method of detection reveals the presence of residues of carcinogenic concern that is below the "no significant risk" level. The OLC does not provide release dates for its opinions, so the release date listed is the date on which the opinion was authored. The original opinion is available at www.justice.gov/file/20181/download.

October 13, 1995