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Referenced Laws
21 U.S.C. 321(qq)
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Section 1
1. Short title This Act may be cited as the Alpha-gal Allergen Inclusion Act.
Section 2
2. Adding alpha-gal to definition of major food allergen Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is amended by adding at the end the following: Galactose-alpha-1,3-galactose (commonly known as alpha-gal). For purposes of this subparagraph, the term galactose-alpha-1,3-galactose includes— ingredients derived from non-catarrhine primate mammals; and red algae in the order Gigartinales. For purposes of this subparagraph, the term galactose-alpha-1,3-galactose does not include mammal-derived ingredients for which the Secretary determines there is no galactose-alpha-1,3-galactose above an established, detectable limit (such as ingredients made from alpha-gal-knockout mammals). The amendment made by subsection (a) shall apply beginning on the date that is 18 months after the date of enactment of this Act. (3)
(A)Galactose-alpha-1,3-galactose (commonly known as alpha-gal). (B)For purposes of this subparagraph, the term galactose-alpha-1,3-galactose includes—
(i)ingredients derived from non-catarrhine primate mammals; and (ii)red algae in the order Gigartinales.
(C)For purposes of this subparagraph, the term galactose-alpha-1,3-galactose does not include mammal-derived ingredients for which the Secretary determines there is no galactose-alpha-1,3-galactose above an established, detectable limit (such as ingredients made from alpha-gal-knockout mammals)..