[117th Congress Public Law 11]
[From the U.S. Government Publishing Office]

[[Page 135 STAT. 262]]

Public Law 117-11
117th Congress

                                 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. <<NOTE: Apr. 23, 2021 -  [S. 578]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Food Allergy 
Safety, Treatment, Education, and Research Act of 2021.>> 
SECTION 1. <<NOTE: 21 USC 301 note.>>  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''.

    (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) <<NOTE: 21 USC 321 note.>>  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.

    (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 
            (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 
                    (B) the development of effective food allergy 
                    (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) <<NOTE: Recommenda- tions. Strategies.>>  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 

[[Page 135 STAT. 263]]

                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) <<NOTE: Web posting.>>  Publication.--The Secretary shall make 
the report under subsection (a) available on the internet website of the 
Department of Health and Human Services.

    Approved April 23, 2021.


            Mar. 3, considered and passed Senate.
            Apr. 14, considered and passed House.