Us Congress 2025-2026 Regular Session

Us Congress House Bill HB2203 Compare Versions

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11 I
22 119THCONGRESS
33 1
44 STSESSION H. R. 2203
55 To amend the Federal Food, Drug, and Cosmetic Act with respect to the
66 regulation of zootechnical animal food substances.
77 IN THE HOUSE OF REPRESENTATIVES
88 MARCH18, 2025
99 Mr. L
1010 ANGWORTHY(for himself, Ms. SCHRIER, Mr. BAIRD, Ms. PINGREE, Mrs.
1111 H
1212 OUCHIN, Mr. COSTA, Mr. MOOLENAAR, Ms. TENNEY, Mr. RILEYof
1313 New York, Mr. J
1414 OHNSONof South Dakota, Mr. PFLUGER, Mr. LATTA,
1515 Mr. J
1616 OYCEof Pennsylvania, Mr. MESSMER, Mr. BENTZ, Mr.
1717 O
1818 BERNOLTE, Mr. MILLERof Ohio, Mr. NUNNof Iowa, Mr. FEENSTRA,
1919 Mr. N
2020 EWHOUSE, Mr. BALDERSON, Mrs. MILLER-MEEKS, Mr. FINSTAD,
2121 Mr. V
2222 ALADAO, Mr. EVANSof Colorado, and Mr. FONG) introduced the
2323 following bill; which was referred to the Committee on Energy and Com-
2424 merce
2525 A BILL
2626 To amend the Federal Food, Drug, and Cosmetic Act with
2727 respect to the regulation of zootechnical animal food
2828 substances.
2929 Be it enacted by the Senate and House of Representa-1
3030 tives of the United States of America in Congress assembled, 2
3131 SECTION 1. SHORT TITLE. 3
3232 This Act may be cited as the ‘‘Innovative Feed En-4
3333 hancement and Economic Development Act of 2025’’ or 5
3434 the ‘‘Innovative FEED Act of 2025’’. 6
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3838 SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD 1
3939 SUBSTANCES. 2
4040 (a) D
4141 EFINITION.—Section 201 of the Federal Food, 3
4242 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 4
4343 adding at the end the following: 5
4444 ‘‘(tt)(1) The term ‘zootechnical animal food sub-6
4545 stance’ means a substance that— 7
4646 ‘‘(A) is added to the food or drinking water of 8
4747 animals; 9
4848 ‘‘(B) is intended to— 10
4949 ‘‘(i) affect the byproducts of the digestive 11
5050 process of an animal; 12
5151 ‘‘(ii) reduce the presence of foodborne 13
5252 pathogens of human health significance in an 14
5353 animal intended to be used for food; or 15
5454 ‘‘(iii) affect the structure or function of the 16
5555 body of the animal, other than by providing nu-17
5656 tritive value, by altering the animal’s gastro-18
5757 intestinal microbiome; and 19
5858 ‘‘(C) achieves its intended effect by acting solely 20
5959 within the gastrointestinal tract of the animal. 21
6060 ‘‘(2) Such term does not include a substance that— 22
6161 ‘‘(A) is intended for use in the diagnosis, cure, 23
6262 mitigation, treatment, or prevention of disease in an 24
6363 animal; 25
6464 ‘‘(B) is a hormone; 26
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6868 ‘‘(C) is an active moiety in an animal drug, 1
6969 which, prior to the filing of a petition under section 2
7070 409 was approved under section 512, conditionally 3
7171 approved under section 571, indexed under section 4
7272 572, or for which substantial clinical investigations 5
7373 have been instituted and for which the existence of 6
7474 such investigations has been made public; 7
7575 ‘‘(D) is an ionophore; or 8
7676 ‘‘(E) is otherwise excluded from the definition 9
7777 based on criteria established by the Secretary 10
7878 through notice and comment rulemaking. 11
7979 ‘‘(3) A zootechnical animal food substance shall be 12
8080 deemed to be a food additive within the meaning of para-13
8181 graph (s) and its introduction into interstate commerce 14
8282 shall be in accordance with a regulation issued under sec-15
8383 tion 409. A zootechnical animal food substance shall not 16
8484 be considered a drug under paragraph (g)(1)(C) solely be-17
8585 cause the substance has an intended effect described in 18
8686 subparagraph (1).’’. 19
8787 (b) F
8888 OODADDITIVES.—Section 409 of the Federal 20
8989 Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amend-21
9090 ed— 22
9191 (1) in subsection (b)— 23
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9595 (A) by redesignating paragraphs (3) 1
9696 through (5) as paragraphs (4) through (6), re-2
9797 spectively; and 3
9898 (B) by inserting after paragraph (2) the 4
9999 following: 5
100100 ‘‘(3) In the case of a zootechnical animal food 6
101101 substance, such petition shall, in addition to any ex-7
102102 planatory or supporting data, contain— 8
103103 ‘‘(A) all relevant data bearing on the effect 9
104104 the zootechnical animal food substance is in-10
105105 tended to have and the quantity of such sub-11
106106 stance required to produce the intended effect; 12
107107 and 13
108108 ‘‘(B) full reports of investigations made 14
109109 with respect to the intended use of such sub-15
110110 stance, including full information as to the 16
111111 methods and controls used in conducting such 17
112112 investigations.’’; 18
113113 (2) in subsection (c)— 19
114114 (A) by amending subparagraph (A) of 20
115115 paragraph (1) to read as follows: 21
116116 ‘‘(A)(i) by order establish a regulation (whether 22
117117 or not in accord with that proposed by the peti-23
118118 tioner) prescribing— 24
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122122 ‘‘(I) with respect to one or more proposed 1
123123 uses of the food additive involved, the condi-2
124124 tions under which such additive may be safely 3
125125 used (including specifications as to the par-4
126126 ticular food or classes of food in or on which 5
127127 such additive may be used, the maximum quan-6
128128 tity which may be used or permitted to remain 7
129129 in or on such food, the manner in which such 8
130130 additive may be added to or used in or on such 9
131131 food, and any directions or other labeling or 10
132132 packaging requirements for such additive as the 11
133133 Secretary determines necessary to assure the 12
134134 safety of such use); and 13
135135 ‘‘(II) in the case of a zootechnical animal 14
136136 food substance, the conditions under which such 15
137137 substance may be used to achieve the intended 16
138138 effect; and 17
139139 ‘‘(ii) notify the petitioner of such order and the 18
140140 reasons for such action; or’’; and 19
141141 (B) in paragraph (3)— 20
142142 (i) in subparagraph (A), by striking ‘‘; 21
143143 or’’ and inserting a semicolon; 22
144144 (ii) in subparagraph (B), by striking 23
145145 the period and inserting ‘‘; or’’; and 24
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149149 (iii) by adding at the end the fol-1
150150 lowing: 2
151151 ‘‘(C) in the case of a zootechnical animal food 3
152152 substance, fails to establish that the proposed use of 4
153153 the substance, under the conditions of use to be 5
154154 specified in the regulation, will achieve the intended 6
155155 effect.’’; and 7
156156 (3) by adding at the end the following: 8
157157 ‘‘(l) Z
158158 OOTECHNICALANIMALFOODSUBSTANCES.— 9
159159 The labeling of a zootechnical animal food substance— 10
160160 ‘‘(1) shall include the statement: ‘Not for use in 11
161161 the diagnosis, cure, mitigation, treatment, or preven-12
162162 tion of disease in animals.’; and 13
163163 ‘‘(2) may include statements regarding the in-14
164164 tended effect of the substance on the structure or 15
165165 function of the body of animals, as set forth in sec-16
166166 tion 201(tt)(1).’’. 17
167167 (c) M
168168 ISBRANDEDFOOD.—Section 403 of the Federal 18
169169 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend-19
170170 ed by adding at the end the following: 20
171171 ‘‘(z) If it is a zootechnical animal food substance and 21
172172 the labeling of the food does not include the statement 22
173173 required by section 409(l)(1).’’. 23
174174 (d) R
175175 ULE OFCONSTRUCTION.—Nothing in this sec-24
176176 tion, or the amendments made by this section, shall be 25
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180180 construed to authorize the Secretary of Health and 1
181181 Human Services to require the use of any zootechnical 2
182182 food substance or food additive (as those terms are defined 3
183183 in section 201 of the Federal Food, Drug, and Cosmetic 4
184184 Act, as amended by subsection (a)). 5
185185 Æ
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