117TH CONGRESS 

1ST SESSION S. 578 

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. 

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

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

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

4 ‘‘FASTER Act of 2021’’. 

5 SEC. 2. FOOD ALLERGY SAFETY. 

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

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

8 amended by striking ‘‘and soybeans’’ and inserting ‘‘soy9 beans, and sesame’’. 

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

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

12 or delivered for introduction into interstate commerce on 

13 or after January 1, 2023. 

14 SEC. 3. REPORT TO CONGRESS. 

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

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

17 Human Services (referred to in this section as the ‘‘Sec18 retary’’) shall submit to the Committee on Health, Edu19 cation, Labor, and Pensions of the Senate and the Com20 mittee on Energy and Commerce of the House of Rep21 resentatives a report that includes— 

22 (1) descriptions of ongoing Federal activities re23 lated to— 

24 (A) the surveillance and collection of data 

25 on the prevalence of food allergies and severity 

26 of allergic reactions for specific food or food in-
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1 gredients, including the identification of any 

2 gaps in such activities; 

3 (B) the development of effective food al4 lergy diagnostics; 

5 (C) the prevention of the onset of food al6 lergies; 

7 (D) the reduction of risks related to living 

8 with food allergies; and 

9 (E) the development of new therapeutics to 

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

11 and 

12 (2) specific recommendations and strategies to 

13 expand, enhance, or improve activities described in 

14 paragraph (1), including— 

15 (A) strategies to improve the accuracy of 

16 food allergy prevalence data by expanding and 

17 intensifying current collection methods, includ18 ing support for research that includes the iden19 tification of biomarkers and tests to validate 

20 survey data and the investigation of the use of 

21 identified biomarkers and tests in national sur22 veys; 

23 (B) strategies to overcome gaps in surveil24 lance and data collection activities related to 

25 food allergies and specific food allergens; and 
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1 (C) recommendations for the development 

2 and implementation of a regulatory process and 

3 framework that would allow for the timely, 

4 transparent, and evidence-based modification of 

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

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

7 and Cosmetic Act (21 U.S.C. 321(qq)), includ8 ing with respect to— 

9 (i) the scientific criteria for defining a 

10 food or food ingredient as a ‘‘major food 

11 allergen’’ pursuant to such process, includ12 ing recommendations pertaining to evi13 dence of the prevalence and severity of al14 lergic reactions to a food or food ingredient 

15 that would be required in order to establish 

16 that such food or food ingredient is an al17 lergen of public health concern appropriate 

18 for such process; and 

19 (ii) opportunities for stakeholder en20 gagement and comment, as appropriate, in 

21 considering any such modification to such 

22 definition. 
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1 (b) PUBLICATION.—The Secretary shall make the re2 port under subsection (a) available on the internet website 

3 of the Department of Health and Human Services. 

Passed the Senate March 3, 2021. 

Attest: 

Secretary. 
117TH CONGRESS 

1ST SESSION S. 578 

AN ACT 

To improve the health and safety of Americans livother purposes. eosinophilic gastrointestinal diseases, and for food protein-induced enterocolitis syndrome, and cluding potentially life-threatening anaphylaxis, ing with food allergies and related disorders, in-