[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 578 Enrolled Bill (ENR)]

        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 protein-induced 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 
        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.