The proposed FASTER legislation is an item focused on food allergens. It had made progress towards getting passed in 2020, but ran out of time and has to be reintroduced.
This legislation would add sesame to the list of allergens requiring labeling, but also opens the door for other allergens to be added at the decision of the Secretary. From the proposed legislation (below) "Any other food ingredient that the Secretary determines by regulation to be a major food allergen, based on the scientific criteria determined by the Secretary (including the prevalence and severity of allergic reactions to the food ingredient) that establish that such food ingredient is an allergen of public health concern.”.
Food Business News
https://www.foodbusinessnews.net/articles/18218-allergens-in-the-crosshairs
Allergens in the crosshairs
03.23.2021By Jay Sjerven
WASHINGTON — Both Congress and federal regulators have accelerated efforts to defend populations whose sensitivity to major food allergens puts them at risk for illness or even death. In Congress, legislation requiring sesame be added to the existing list of eight major allergens subject to labeling requirements advanced with the Senate’s unanimous passage of the Food Allergy, Safety, Treatment, Education (FASTER) Act on March 3.
At the same time, the Food and Drug Administration in recent statements and through warning letters affirmed its commitment to ensuring food manufacturers comply with existing regulations pertaining to labeling allergens when they are present in foods. The FDA also warned food companies to ensure their manufacturing practices effectively prevent allergen contamination of foods that are supposed to be free from the major allergens.
On the legislative front, with the FASTER Act’s passage in the Senate, attention shifted to the House of Representatives, where the bill was introduced on Feb. 22.
Both the Senate and House passed the FASTER Act in 2020, but the 116th Congress was adjourned before the House could consider the Senate’s revised version of the bill. This left the bill to be reintroduced in each chamber when the 117th Congress convened. Final passage was not in question.
In addition to declaring sesame the ninth food allergen for which the Food and Drug Administration requires plain-language labeling, the FASTER Act would establish a process and framework for determining what additional allergens should be covered by the Federal Food, Drug, and Cosmetic Act.
Rest of Article - https://www.foodbusinessnews.net/articles/18218-allergens-in-the-crosshairs
H. R. 2117
IN THE SENATE OF THE UNITED STATES
November 18, 2020
Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions
AN ACT
To improve the health and safety of Americans living with food allergies and related disorders, including potentially life-threatening anaphylaxis, food protein-induced enterocolitis syndrome, and eosinophilic gastrointestinal diseases, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Food Allergy Safety, Treatment, Education, and Research Act of 2020” or the “FASTER Act of 2020”.
SEC. 2. FOOD ALLERGY SAFETY RECOMMENDATIONS OF THE NATIONAL ACADEMY OF MEDICINE.
(a) Collection Of Food Allergy Data.—The Public Health Service Act is amended by inserting before section 318 of such Act (42 U.S.C. 247c) the following new section:
“SEC. 317W. COLLECTION OF FOOD ALLERGY DATA.
“(a) In General.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
“(1) expand and intensify the collection of information on the prevalence of food allergies for specific allergens in the United States, such as through the National Health and Nutrition Examination Survey and the National Health Interview Survey;
“(2) include such information within annual or other periodic reporting to the Congress and the public on other surveillance activities; and
“(3) encourage research to improve the accuracy of food allergy prevalence data.
“(b) Biomarkers.—Any research conducted pursuant to subsection (a)(3) shall include—
“(1) the identification of biomarkers and tests to validate data generated from such research; and
“(2) the investigation of the use of identified biomarkers and tests in national surveys conducted as part of that research.”.
(b) Allergen Labeling.—
(1) MAJOR FOOD ALLERGEN DEFINITION.—
(A) IN GENERAL.—Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by striking “and soybeans” and inserting “soybeans, and sesame”.
(B) EFFECTIVE DATE.—The amendment made by subparagraph (A) shall apply with respect to food introduced or delivered for introduction into interstate commerce on or after January 1, 2022.
(2) ADDITIONAL ALLERGENS.—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:
“(3) Any other food ingredient that the Secretary determines by regulation to be a major food allergen, based on the scientific criteria determined by the Secretary (including the prevalence and severity of allergic reactions to the food ingredient) that establish that such food ingredient is an allergen of public health concern.”.
(3) TECHNICAL CORRECTIONS.—Section 201(qq)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(2)) is amended by striking “paragraph” each place it appears and inserting “subparagraph”.
SEC. 3. REPORT ON USE BY FDA OF PATIENT EXPERIENCE DATA ON TREATMENTS FOR PATIENTS WITH FOOD ALLERGIES.
Section 3004 of the 21st Century Cures Act (21 U.S.C. 355 note) is amended—
(1) by striking “Not later than” and inserting the following:
“(a) In General.—Not later than”; and
(2) by adding at the end the following:
“(b) Treatments For Patients With Food Allergies.—Each report under subsection (a) shall include a synopsis of the use by the Food and Drug Administration in regulatory decisionmaking of patient experience data on products with an indication for the treatment of a food allergy.”.
Passed the House of Representatives November 17, 2020.
https://codes.findlaw.com/us/title-21-food-and-drugs/21-usc-sect-321.html
21 U.S.C. § 321 - U.S. Code - Unannotated Title 21. Food and Drugs § 321. Definitions; generall
Section 201 (qq)
(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 343(w) of this title.
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