II 

117TH CONGRESS 

1ST SESSION S. 578 

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. 

IN THE SENATE OF THE UNITED STATES 

MARCH 3, 2021 

Mr. SCOTT of South Carolina (for himself, Mr. MURPHY, Ms. COLLINS, Mrs. 

GILLIBRAND, Mr. TILLIS, Mr. BLUMENTHAL, Ms. BALDWIN, Mr. MARSHALL, and Mr. WARNOCK) introduced the following bill; which was read 

twice, considered, read the third time, and passed 

A BILL 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Allergy Safety, 

5 Treatment, Education, and Research Act of 2021’’ or the 

6 ‘‘FASTER Act of 2021’’. 


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1 SEC. 2. FOOD ALLERGY SAFETY. 

2 (a) IN GENERAL.—Section 201(qq)(1) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is 

4 amended by striking ‘‘and soybeans’’ and inserting ‘‘soy5 beans, and sesame’’. 

6 (b) EFFECTIVE DATE.—The amendment made by 

7 subsection (a) shall apply to any food that is introduced 

8 or delivered for introduction into interstate commerce on 

9 or after January 1, 2023. 

10 SEC. 3. REPORT TO CONGRESS. 

11 (a) REPORT.—Not later than 18 months after the 

12 date of enactment of this Act, the Secretary of Health and 

13 Human Services (referred to in this section as the ‘‘Sec14 retary’’) shall submit to the Committee on Health, Edu15 cation, Labor, and Pensions of the Senate and the Com16 mittee on Energy and Commerce of the House of Rep17 resentatives a report that includes— 

18 (1) descriptions of ongoing Federal activities re19 lated to— 

20 (A) the surveillance and collection of data 

21 on the prevalence of food allergies and severity 

22 of allergic reactions for specific food or food in23 gredients, including the identification of any 

24 gaps in such activities; 

25 (B) the development of effective food al26 lergy diagnostics; 


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1 (C) the prevention of the onset of food al2 lergies; 

3 (D) the reduction of risks related to living 

4 with food allergies; and 

5 (E) the development of new therapeutics to 

6 prevent, treat, cure, and manage food allergies; 

7 and 

8 (2) specific recommendations and strategies to 

9 expand, enhance, or improve activities described in 

10 paragraph (1), including— 

11 (A) strategies to improve the accuracy of 

12 food allergy prevalence data by expanding and 

13 intensifying current collection methods, includ14 ing support for research that includes the iden15 tification of biomarkers and tests to validate 

16 survey data and the investigation of the use of 

17 identified biomarkers and tests in national sur18 veys; 

19 (B) strategies to overcome gaps in surveil20 lance and data collection activities related to 

21 food allergies and specific food allergens; and 

22 (C) recommendations for the development 

23 and implementation of a regulatory process and 

24 framework that would allow for the timely, 

25 transparent, and evidence-based modification of 


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1 the definition of ‘‘major food allergen’’ included 

2 in section 201(qq) of the Federal Food, Drug 

3 and Cosmetic Act (21 U.S.C. 321(qq)), includ4 ing with respect to— 

5 (i) the scientific criteria for defining a 

6 food or food ingredient as a ‘‘major food 

7 allergen’’ pursuant to such process, includ8 ing recommendations pertaining to evi9 dence of the prevalence and severity of al10 lergic reactions to a food or food ingredient 

11 that would be required in order to establish 

12 that such food or food ingredient is an al13 lergen of public health concern appropriate 

14 for such process; and 

15 (ii) opportunities for stakeholder en16 gagement and comment, as appropriate, in 

17 considering any such modification to such 

18 definition. 

19 (b) PUBLICATION.—The Secretary shall make the re20 port under subsection (a) available on the internet website 

21 of the Department of Health and Human Services. 

Æ 


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