Innovative FEED Act

II 118TH CONGRESS 1ST SESSION S. 1842 To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of zootechnical animal food substances. IN THE SENATE OF THE UNITED STATES JUNE 7, 2023 Mr. MARSHALL (for himself, Ms. BALDWIN, Mr. MORAN, and Mr. BENNET) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of zootechnical animal food substances. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Innovative Feed En- 4 hancement and Economic Development Act of 2023’’ or 5 the ‘‘Innovative FEED Act’’. 6 VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1842 IS SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD 1 SUBSTANCES. 2 (a) DEFINITION.—Section 201 of the Federal Food, 3 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 4 adding at the end the following: 5 ‘‘(tt)(1) The term ‘zootechnical animal food sub- 6 stance’ means a substance that— 7 ‘‘(A) is added to the food or drinking water of 8 animals; 9 ‘‘(B) is intended to— 10 ‘‘(i) affect the byproducts of the digestive 11 process of an animal; 12 ‘‘(ii) reduce the presence of foodborne 13 pathogens of human health significance in an 14 animal intended to be used for food; or 15 ‘‘(iii) affect the structure or function of the 16 body of the animal, other than by providing nu- 17 tritive value, by altering the animal’s gastro- 18 intestinal microbiome; and 19 ‘‘(C) achieves its intended effect by acting solely 20 within the gastrointestinal tract of the animal. 21 ‘‘(2) Such term does not include a substance that— 22 ‘‘(A) is intended for use in the diagnosis, cure, 23 mitigation, treatment, or prevention of disease in an 24 animal; 25 ‘‘(B) is a hormone; 26 VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1842 IS ‘‘(C) is an active moiety in an animal drug, 1 which, prior to the filing of a petition under section 2 409 was approved under section 512, conditionally 3 approved under section 571, indexed under section 4 572, or for which substantial clinical investigations 5 have been instituted and for which the existence of 6 such investigations has been made public; 7 ‘‘(D) is an ionophore; or 8 ‘‘(E) is otherwise excluded from the definition 9 based on criteria established by the Secretary 10 through notice and comment rulemaking. 11 ‘‘(3) A zootechnical animal food substance shall be 12 deemed to be a food additive within the meaning of para- 13 graph (s) and its introduction into interstate commerce 14 shall be in accordance with a regulation issued under sec- 15 tion 409. A zootechnical animal food substance shall not 16 be considered a drug under paragraph (g)(1)(C) solely be- 17 cause the substance has an intended effect described in 18 subparagraph (1).’’. 19 (b) FOOD ADDITIVES.—Section 409 of the Federal 20 Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amend- 21 ed— 22 (1) in subsection (b)— 23 VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1842 IS (A) by redesignating paragraphs (3) 1 through (5) as paragraphs (4) through (6), re- 2 spectively; and 3 (B) by inserting after paragraph (2) the 4 following: 5 ‘‘(3) In the case of a zootechnical animal food 6 substance, such petition shall, in addition to any ex- 7 planatory or supporting data, contain— 8 ‘‘(A) all relevant data bearing on the effect 9 the zootechnical animal food substance is in- 10 tended to have and the quantity of such sub- 11 stance required to produce the intended effect; 12 and 13 ‘‘(B) full reports of investigations made 14 with respect to the intended use of such sub- 15 stance, including full information as to the 16 methods and controls used in conducting such 17 investigations.’’; 18 (2) in subsection (c)— 19 (A) by amending subparagraph (A) of 20 paragraph (1) to read as follows: 21 ‘‘(A)(i) by order establish a regulation (whether 22 or not in accord with that proposed by the peti- 23 tioner) prescribing— 24 VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1842 IS ‘‘(I) with respect to one or more proposed 1 uses of the food additive involved, the condi- 2 tions under which such additive may be safely 3 used (including specifications as to the par- 4 ticular food or classes of food in or on which 5 such additive may be used, the maximum quan- 6 tity which may be used or permitted to remain 7 in or on such food, the manner in which such 8 additive may be added to or used in or on such 9 food, and any directions or other labeling or 10 packaging requirements for such additive as the 11 Secretary determines necessary to assure the 12 safety of such use); and 13 ‘‘(II) in the case of a zootechnical animal 14 food substance, the conditions under which such 15 substance may be used to achieve the intended 16 effect; and 17 ‘‘(ii) notify the petitioner of such order and the 18 reasons for such action; or’’; and 19 (B) in paragraph (3)— 20 (i) in subparagraph (A), by striking ‘‘; 21 or’’ and inserting a semicolon; 22 (ii) in subparagraph (B), by striking 23 the period and inserting ‘‘; or’’; and 24 VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1842 IS (iii) by adding at the end the fol- 1 lowing: 2 ‘‘(C) in the case of a zootechnical animal food 3 substance, fails to establish that the proposed use of 4 the substance, under the conditions of use to be 5 specified in the regulation, will achieve the intended 6 effect.’’; and 7 (3) by adding at the end the following: 8 ‘‘(l) ZOOTECHNICAL ANIMAL FOOD SUBSTANCES.— 9 The labeling of a zootechnical animal food substance— 10 ‘‘(1) shall include the statement: ‘Not for use in 11 the diagnosis, cure, mitigation, treatment, or preven- 12 tion of disease in animals.’; and 13 ‘‘(2) may include statements regarding the in- 14 tended effect of the substance on the structure or 15 function of the body of animals, as set forth in sec- 16 tion 201(tt)(1).’’. 17 (c) MISBRANDED FOOD.—Section 403 of the Federal 18 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend- 19 ed by adding at the end the following: 20 ‘‘(z) If it is a zootechnical animal food substance and 21 the labeling of the food does not include the statement 22 required by section 409(l)(1).’’. 23 (d) RULE OF CONSTRUCTION.—Nothing in this sec- 24 tion, or the amendments made by this section, shall be 25 VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 1842 IS construed to authorize the Secretary of Health and 1 Human Services to require the use of any zootechnical 2 food substance or food additive (as those terms are defined 3 in section 201 of the Federal Food, Drug, and Cosmetic 4 Act, as amended by subsection (a)). 5 Æ VerDate Sep 11 2014 01:09 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S1842.IS S1842 pbinns on DSKJLVW7X2PROD with $$_JOB