(a) This subpart E applies to all new animal drug applications, food additive petitions, color additive petitions, and requests for import tolerances concerning any compound intended for use in food-producing animals (including supplemental applications and amendments to petitions).

(b) This subpart E also applies in the following manner to compounds already approved:

(1) For those compounds that FDA determines may induce cancer when ingested by man or animals, i.e., suspect carcinogens, §§ 500.80(b), 500.82, and 500.90 apply.

(2) For those compounds that FDA determines have been shown to induce cancer when ingested by man or animals, §§ 500.82 through 500.90 apply.

[52 FR 49586, Dec. 31, 1987, as amended at 86 FR 52410, Sept. 21, 2021]