,,ii #aaith ,,congress #ast ,session ,s4 #aijf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bb1 #bjbe,mr4 ,marshall 7for himself1 ,ms4 ,baldwin1 ,mr4 ,moran1 ,mr4 ,bennet1 ,mr4 ,grassley1 ,mr4 ,king1 and ,ms4 ,klobuchar7 introduced the following bill2 which was read twice and referred to the ,committee on ,agriculture1 ,nutrition1 and ,forestry ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to the regulation of zootechnical animal food substances4 #a4 ,short title ,this ,act may be cited as the ,innovative ,feed ,enhancement and ,economic ,development ,act of #bjbe or the ,innovative ,,feed ,act of #bjbe4 #b4 ,regulation of zootechnical animal food substances 7a7 ,definition ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended by adding at the end the following3 7tt7 7#a7 ,the term zootechnical animal food substance means a substance that-- 7,a7 is added to the food or drinking water of animals2 7,b7 is intended to-- 7i7 affect the byproducts of the digestive process of an animal2 7ii7 reduce the presence of foodborne pathogens of human health significance in an animal intended to be used for food2 or 7iii7 affect the structure or function of the body of the animal1 other than by providing nutritive value1 by altering the animal's gastrointestinal microbiome2 and 7,c7 achieves its intended effect by acting solely within the gastrointestinal tract of the animal4 7#b7 ,such term does not include a substance that-- 7,a7 is intended for use in the diagnosis1 cure1 mitigation1 treatment1 or prevention of disease in an animal2 7,b7 is a hormone2 7,c7 is an active moiety in an animal drug1 which1 prior to the filing of a petition under section #dji1 was approved under section #eab1 conditionally approved under section #ega1 indexed under section #egb1 or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public2 7,d7 is an ionophore2 or 7,e7 is otherwise excluded from the definition based on criteria established by the ,secretary through notice and comment rulemaking4 7#c7 ,a zootechnical animal food substance shall be deemed to be a food additive within the meaning of paragraph 7s7 and its introduction into interstate commerce shall be in accordance with a regulation issued under section #dji4 ,a zootechnical animal food substance shall not be considered a drug under paragraph 7g77#a77;,c7 solely because the substance has an intended effect described in subparagraph 7#a74 4 7b7 ,food additives ,section #dji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdh7 is amended-- 7#a7 in subsection 7b7-- 7,a7 by redesignating paragraphs 7#c7 through 7#e7 as paragraphs 7#d7 through 7#f71 respectively2 and 7,b7 by inserting after paragraph 7#b7 the following3 7#c7 ,in the case of a zootechnical animal food substance1 such petition shall1 in addition to any explanatory or supporting data1 contain-- 7,a7 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 effect2 and 7,b7 full reports of investigations made with respect to the intended use of such substance1 including full information as to the methods and controls used in conducting such investigations4 2 7#b7 in subsection 7c7-- 7,a7 by amending subparagraph 7,a7 of paragraph 7#a7 to read as follows3 7,a7 7i7 by order establish a regulation 7whether or not in accord with that proposed by the petitioner7 prescribing-- 7,i7 with respect to one or more proposed uses of the food additive involved1 the conditions under which such additive may be safely used 7including specifications as to the particular food or classes of food in or on which such additive may be used1 the maximum quantity which may be used or permitted to remain in or on such food1 the manner in which such additive may be added to or used in or on such food1 and any directions or other labeling or packaging requirements for such additive as the ,secretary determines necessary to assure the safety of such use72 and 7,,ii7 in the case of a zootechnical animal food substance1 the conditions under which such substance may be used to achieve the intended effect2 and 7ii7 notify the petitioner of such order and the reasons for such action2 or 2 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,a71 by striking 2 or and inserting a semicolon2 7ii7 in subparagraph 7,b71 by striking the period and inserting 2 or2 and 7iii7 by adding at the end the following3 7,c7 in the case of a zootechnical animal food substance1 fails to establish that the proposed use of the substance1 under the conditions of use to be specified in the regulation1 will achieve the intended effect4 2 and 7#c7 by adding at the end the following3 7l7 ,zootechnical animal food substances ,the labeling of a zootechnical animal food substance-- 7#a7 shall include the statement3 ,not for use in the diagnosis1 cure1 mitigation1 treatment1 or prevention of disease in animals42 and 7#b7 may include statements regarding the intended effect of the substance on the structure or function of the body of animals1 as set forth in section #bja7tt77#a74 4 7c7 ,misbranded food ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following3 7z7 ,if it is a zootechnical animal food substance and the labeling of the food does not include the statement required by section #dji7l77#a74 4 7d7 ,rule of construction ,nothing in this section1 or the amendments made by this section1 shall be construed to authorize the ,secretary of ,health and ,human ,services to require the use of any zootechnical food substance or food additive 7as those terms are defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a774