Page:United States Statutes at Large Volume 118.djvu/938

 118 STAT. 908 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 201(qq)(2) from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing— ‘‘(i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or ‘‘(ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 409. ‘‘(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90 day period that the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health. ‘‘(C) The Secretary shall promptly post to a public site all notifications received under this subparagraph within 14 days of receipt and promptly post any objections thereto by the Secretary. ‘‘(x) Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.’’. (b) EFFECT ON OTHER AUTHORITY.—The amendments made by this section that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other food allergens. (c) CONFORMING AMENDMENTS.— (1) Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) (as amended by section 102(b)) is amended by adding at the end the following: ‘‘(qq) The term ‘major food allergen’ means any of the following: ‘‘(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. ‘‘(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: ‘‘(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil. ‘‘(B) A food ingredient that is exempt under paragraph (6) or (7) of section 403(w).’’. (2) Section 403A(a)(2) of the Federal Food, Drug, and Cos metic Act (21 U.S.C. 343–1(a)(2)) is amended by striking ‘‘or 403(i)(2)’’ and inserting ‘‘403(i)(2), 403(w), or 403(x)’’. (d) EFFECTIVE DATE.—The amendments made by this section shall apply to any food that is labeled on or after January 1, 2006. Applicability. 21 USC 321 note. 21 USC 343 note. Public information. Deadline. Deadlines.

�