S. 578 

One Hundred Seventeenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Sunday, 

the third day of January, two thousand and twenty one 

An Act 

To improve the health and safety of Americans living with food allergies and 

related disorders, including potentially life-threatening anaphylaxis, food proteininduced 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 2021’’ or the ‘‘FASTER Act of 

2021’’. 

SEC. 2. FOOD ALLERGY SAFETY. 

(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 subsection (a) 

shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023. 

SEC. 3. REPORT TO CONGRESS. 

(a) REPORT.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services 

(referred to in this section as the ‘‘Secretary’’) shall submit to 

the Committee on Health, Education, Labor, and Pensions of the 

Senate and the Committee on Energy and Commerce of the House 

of Representatives a report that includes— 

(1) descriptions of ongoing Federal activities related to— 

(A) the surveillance and collection of data on the prevalence of food allergies and severity of allergic reactions 

for specific food or food ingredients, including the identification of any gaps in such activities; 

(B) the development of effective food allergy 

diagnostics; 

(C) the prevention of the onset of food allergies; 

(D) the reduction of risks related to living with food 

allergies; and 

(E) the development of new therapeutics to prevent, 

treat, cure, and manage food allergies; and 

(2) specific recommendations and strategies to expand, 

enhance, or improve activities described in paragraph (1), 

including— 

(A) strategies to improve the accuracy of food allergy 

prevalence data by expanding and intensifying current 
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collection methods, including support for research that 

includes the identification of biomarkers and tests to validate survey data and the investigation of the use of identified biomarkers and tests in national surveys; 

(B) strategies to overcome gaps in surveillance and 

data collection activities related to food allergies and specific food allergens; and 

(C) recommendations for the development and 

implementation of a regulatory process and framework that 

would allow for the timely, transparent, and evidence-based 

modification of the definition of ‘‘major food allergen’’ 

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

Cosmetic Act (21 U.S.C. 321(qq)), including with respect 

to— 

(i) the scientific criteria for defining a food or food 

ingredient as a ‘‘major food allergen’’ pursuant to such 

process, including recommendations pertaining to evidence of the prevalence and severity of allergic reactions to a food or food ingredient that would be required 

in order to establish that such food or food ingredient 

is an allergen of public health concern appropriate 

for such process; and 

(ii) opportunities for stakeholder engagement and 

comment, as appropriate, in considering any such 

modification to such definition. 

(b) PUBLICATION.—The Secretary shall make the report under 

subsection (a) available on the internet website of the Department 

of Health and Human Services. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.