| 1 | 1 | | I |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION H. R. 1178 |
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| 5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal |
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| 6 | 6 | | to the definition of ‘‘major food allergen’’. |
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| 7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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| 8 | 8 | | FEBRUARY10, 2025 |
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| 9 | 9 | | Mr. V |
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| 10 | 10 | | ANDREW(for himself, Mr. MURPHY, Mr. DAVISof North Carolina, Mr. |
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| 11 | 11 | | B |
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| 12 | 12 | | ALDERSON, Mr. CARTERof Texas, Mr. LAMALFA, Mr. GRIFFITH, Mr. |
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| 13 | 13 | | M |
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| 14 | 14 | | AGAZINER, Mr. MOOREof Alabama, Ms. NORTON, Mr. RULLI, Mr. |
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| 15 | 15 | | C |
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| 16 | 16 | | LINE, Mr. WITTMAN, Mrs. CHERFILUS-MCCORMICK, and Mr. SMITHof |
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| 17 | 17 | | New Jersey) introduced the following bill; which was referred to the Com- |
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| 18 | 18 | | mittee on Energy and Commerce |
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| 19 | 19 | | A BILL |
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| 20 | 20 | | To amend the Federal Food, Drug, and Cosmetic Act to |
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| 21 | 21 | | add alpha-gal to the definition of ‘‘major food allergen’’. |
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| 22 | 22 | | Be it enacted by the Senate and House of Representa-1 |
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| 23 | 23 | | tives of the United States of America in Congress assembled, 2 |
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| 24 | 24 | | SECTION 1. SHORT TITLE. 3 |
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| 25 | 25 | | This Act may be cited as the ‘‘Alpha-gal Allergen In-4 |
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| 26 | 26 | | clusion Act’’. 5 |
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| 27 | 27 | | VerDate Sep 11 2014 17:09 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1178.IH H1178 |
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| 28 | 28 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 29 | 29 | | •HR 1178 IH |
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| 30 | 30 | | SEC. 2. ADDING ALPHA-GAL TO DEFINITION OF ‘‘MAJOR 1 |
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| 31 | 31 | | FOOD ALLERGEN’’. 2 |
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| 32 | 32 | | (a) I |
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| 33 | 33 | | NGENERAL.—Section 201(qq) of the Federal 3 |
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| 34 | 34 | | Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is 4 |
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| 35 | 35 | | amended by adding at the end the following: 5 |
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| 36 | 36 | | ‘‘(3)(A) Galactose-alpha-1,3-galactose (com-6 |
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| 37 | 37 | | monly known as ‘alpha-gal’). 7 |
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| 38 | 38 | | ‘‘(B) For purposes of this subparagraph, the 8 |
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| 39 | 39 | | term ‘galactose-alpha-1,3-galactose’ includes— 9 |
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| 40 | 40 | | ‘‘(i) ingredients derived from non- 10 |
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| 41 | 41 | | catarrhine primate mammals; and 11 |
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| 42 | 42 | | ‘‘(ii) red algae in the order Gigartinales. 12 |
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| 43 | 43 | | ‘‘(C) For purposes of this subparagraph, the 13 |
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| 44 | 44 | | term ‘galactose-alpha-1,3-galactose’ does not include 14 |
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| 45 | 45 | | mammal-derived ingredients for which the Secretary 15 |
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| 46 | 46 | | determines there is no galactose-alpha-1,3-galactose 16 |
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| 47 | 47 | | above an established, detectable limit (such as ingre-17 |
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| 48 | 48 | | dients made from alpha-gal-knockout mammals).’’. 18 |
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| 49 | 49 | | (b) E |
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| 50 | 50 | | FFECTIVEDATE.—The amendment made by 19 |
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| 51 | 51 | | subsection (a) shall apply beginning on the date that is 20 |
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| 52 | 52 | | 18 months after the date of enactment of this Act. 21 |
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| 53 | 53 | | Æ |
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| 54 | 54 | | VerDate Sep 11 2014 17:09 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H1178.IH H1178 |
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| 55 | 55 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
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