; (D) is an ionophore; or (E) is otherwise excluded from the definition based on criteria established by the Secretary through notice and comment rulemaking. (3) A zootechnical animal food substance shall be deemed to be a food additive within the meaning of paragraph (s) and its introduction into interstate commerce shall be in accordance with a regulation issued under section 409. A zootechnical animal food substance shall not be considered a drug under paragraph (g)(1)(C) solely because the substance has an intended effect described in subparagraph (1). . (b) Food additives Section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348 ) is amended— (1) in subsection (b)— (A) by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively; and (B) by inserting after paragraph (2) the following: (3) In the case of a zootechnical animal food substance, such petition shall, in addition to any explanatory or supporting data, contain— (A) all relevant data bearing on the effect the zootechnical animal food substance is intended to have and the quantity of such substance required to produce the intended effect; and (B) full reports of investigations made with respect to the intended use of such substance, including full information as to the methods and controls used in conducting such investigations.