FASTER Act of 2020

116TH CONGRESS 2D SESSION S. 3451 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 Representa- 1 tives of the United States of America in Congress assembled, 2 2 † S 3451 ES SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Food Allergy Safety, 2 Treatment, Education, and Research Act of 2020’’ or the 3 ‘‘FASTER Act of 2020’’. 4 SEC. 2. FOOD ALLERGY SAFETY. 5 (a) IN GENERAL.—Section 201(qq)(1) of the Federal 6 Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is 7 amended by striking ‘‘and soybeans’’ and inserting ‘‘soy- 8 beans, and sesame’’. 9 (b) EFFECTIVE DATE.—The amendment made by 10 subsection (a) shall apply to any food that is introduced 11 or delivered for introduction into interstate commerce on 12 or after January 1, 2023. 13 SEC. 3. REPORT TO CONGRESS. 14 (a) REPORT.—Not later than 18 months after the 15 date of enactment of this Act, the Secretary of Health and 16 Human Services (referred to in this section as the ‘‘Sec- 17 retary’’) shall submit to the Committee on Health, Edu- 18 cation, Labor, and Pensions of the Senate and the Com- 19 mittee on Energy and Commerce of the House of Rep- 20 resentatives a report that includes— 21 (1) descriptions of ongoing Federal activities re- 22 lated to— 23 (A) the surveillance and collection of data 24 on the prevalence of food allergies and severity 25 of allergic reactions for specific food or food in- 26 3 † S 3451 ES gredients, including the identification of any 1 gaps in such activities; 2 (B) the development of effective food al- 3 lergy diagnostics; 4 (C) the prevention of the onset of food al- 5 lergies; 6 (D) the reduction of risks related to living 7 with food allergies; and 8 (E) the development of new therapeutics to 9 prevent, treat, cure, and manage food allergies; 10 and 11 (2) specific recommendations and strategies to 12 expand, enhance, or improve activities described in 13 paragraph (1), including— 14 (A) strategies to improve the accuracy of 15 food allergy prevalence data by expanding and 16 intensifying current collection methods, includ- 17 ing support for research that includes the iden- 18 tification of biomarkers and tests to validate 19 survey data and the investigation of the use of 20 identified biomarkers and tests in national sur- 21 veys; 22 (B) strategies to overcome gaps in surveil- 23 lance and data collection activities related to 24 food allergies and specific food allergens; and 25 4 † S 3451 ES (C) recommendations for the development 1 and implementation of a regulatory process and 2 framework that would allow for the timely, 3 transparent, and evidence-based modification of 4 the definition of ‘‘major food allergen’’ included 5 in section 201(qq) of the Federal Food, Drug 6 and Cosmetic Act (21 U.S.C. 321(qq)), includ- 7 ing with respect to— 8 (i) the scientific criteria for defining a 9 food or food ingredient as a ‘‘major food 10 allergen’’ pursuant to such process, includ- 11 ing recommendations pertaining to evi- 12 dence of the prevalence and severity of al- 13 lergic reactions to a food or food ingredient 14 that would be required in order to establish 15 that such food or food ingredient is an al- 16 lergen of public health concern appropriate 17 for such process; and 18 (ii) opportunities for stakeholder en- 19 gagement and comment, as appropriate, in 20 considering any such modification to such 21 definition. 22 5 † S 3451 ES (b) PUBLICATION.—The Secretary shall make the re- 1 port under subsection (a) available on the internet website 2 of the Department of Health and Human Services. 3 Passed the Senate December 9, 2020. Attest: Secretary. 116TH CONGRESS 2D SESSION S. 3451 AN ACT To improve the health and safety of Americans liv- ing with food allergies and related disorders, in- cluding potentially life-threatening anaphylaxis, food protein-induced enterocolitis syndrome, and eosinophilic gastrointestinal diseases, and for other purposes.