[Congressional Record Volume 167, Number 40 (Wednesday, March 3, 2021)]
[Senate]
[Page S1029]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SCOTT of South Carolina (for himself, Mr. Murphy, Ms. 
        Collins, Mrs. Gillibrand, Mr. Tillis, Mr. Blumenthal, Ms. 
        Baldwin, Mr. Marshall, and Mr. Warnock):
  S. 578. A bill 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; 
considered and passed.

                                 S. 578

       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.
                                 ______