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 ‘‘soy-
beans, 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 ‘‘Sec-
retary’’) shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives a report that includes— 
(1) descriptions of ongoing Federal activities re-
lated to— 
(A) the surveillance and collection of data 
on the prevalence of food allergies and severity 
of allergic reactions for specific food or food in-
gredients, including the identification of any 
gaps in such activities; 
(B) the development of effective food al-
lergy diagnostics; 
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(C) the prevention of the onset of food al-
lergies; 
(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 collection methods, includ-
ing support for research that includes the iden-
tification of biomarkers and tests to validate 
survey data and the investigation of the use of 
identified biomarkers and tests in national sur-
veys; 
(B) strategies to overcome gaps in surveil-
lance 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 
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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)), includ-
ing with respect to— 
(i) the scientific criteria for defining a 
food or food ingredient as a ‘‘major food 
allergen’’ pursuant to such process, includ-
ing recommendations pertaining to evi-
dence of the prevalence and severity of al-
lergic reactions to a food or food ingredient 
that would be required in order to establish 
that such food or food ingredient is an al-
lergen of public health concern appropriate 
for such process; and 
(ii) opportunities for stakeholder en-
gagement and comment, as appropriate, in 
considering any such modification to such 
definition. 
(b) PUBLICATION.—The Secretary shall make the re-
port under subsection (a) available on the internet website 
of the Department of Health and Human Services. 
Æ 
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