[Congressional Record Volume 166, Number 208 (Wednesday, December 9, 2020)]
[Senate]
[Pages S7292-S7293]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  FOOD ALLERGY SAFETY, TREATMENT, EDUCATION, AND RESEARCH ACT OF 2020

  Mr. THUNE. Mr. President, as if in legislative session, I ask 
unanimous consent that the Committee on Health, Education, Labor, and 
Pensions be discharged from further consideration of S. 3451 and the 
Senate proceed to its immediate consideration.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The senior assistant legislative clerk read as follows:

       A bill (S. 3451) 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.

  There being no objection, the committee was discharged, and the 
Senate proceeded to consider the bill.
  Mr. THUNE. I ask unanimous consent that the Scott of South Carolina 
substitute amendment at the desk be agreed to, that the bill, as 
amended, be considered read a third time and passed, and that the 
motion to reconsider be considered made and laid upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 2695), in the nature of a substitute, was agreed 
to, as follows

                (Purpose: In the nature of a substitute)

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food Allergy Safety, 
     Treatment, Education, and Research Act of 2020'' or the 
     ``FASTER Act of 2020''.

     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.

  The bill (S. 3451), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed as follows:

                                S. 3451

       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 2020'' or the 
     ``FASTER Act of 2020''.

     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;

[[Page S7293]]

       (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.

                          ____________________