---
kind: "diff"
citation: "S. 3451"
bill: "116-s-3451"
heading: "Food Allergy Safety, Treatment, Education, and Research Act of 2020"
from: "is"
from_label: "Introduced in Senate"
to: "es"
to_label: "Engrossed in Senate"
sections_amended: 2
sections_added: 0
sections_removed: 0
url: "https://uscodex.org/bills/116/s/3451/changes/es"
---

# S. 3451 — what changed

S. 3451, Food Allergy Safety, Treatment, Education, and Research Act of 2020 — 2 sections amended between Introduced in Senate and Engrossed in Senate.

Edits are marked `<del>struck</del>` and `<ins>inserted</ins>`.

## 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 <del>first </del>introduced <ins>or delivered for introduction </ins>into interstate commerce on or after January 1, <del>2022.</del><ins>2023.</ins>

## Sec. 3 Report to Congress

- (a) Report— Not later than <del>2 years </del><ins>18 months </ins>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 <del>on scientific opportunities in food allergy research. Such report shall—</del><ins>that includes—</ins>
  - (1) <del>identify opportunities and challenges </del><ins>descriptions of ongoing Federal activities </ins>related to—
    - (A) <del>developing effective </del><ins>the surveillance and collection of data on the prevalence of </ins>food <del>allergy diagnostics;</del><ins>allergies and severity of allergic reactions for specific food or food ingredients, including the identification of any gaps in such activities;</ins>
    - (B) <del>preventing </del>the <del>onset </del><ins>development </ins>of <ins>effective </ins>food <del>allergies;</del><ins>allergy diagnostics;</ins>
    - (C) <del>reducing </del>the <del>risks </del><ins>prevention </ins>of <del>living with </del><ins>the onset of </ins>food allergies;
    - (D) <del>developing new therapeutics </del><ins>the reduction of risks related </ins>to <del>treat and manage </del><ins>living with </ins>food allergies; and
    - (E) <del>curing </del><ins>the development of new therapeutics to prevent, treat, cure, and manage </ins>food <del>allergies;</del><ins>allergies; and</ins>
  - (2) <del>provide updates on data collection activities related to food allergies and </del>specific <del>allergens </del><ins>recommendations </ins>and <del>identify gaps </del><ins>strategies to expand, enhance, or improve activities described </ins>in <del>such data collection activities; and</del><ins>paragraph (1), including—</ins>
    - (A) <ins>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;</ins>
    - (B) <ins>strategies to overcome gaps in surveillance and data collection activities related to food allergies and specific food allergens; and</ins>
    - (C) <ins>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—</ins>
      - (i) <ins>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</ins>
      - (ii) <ins>opportunities for stakeholder engagement and comment, as appropriate, in considering any such modification to such definition.</ins>
  - (3) <del>recommend specific strategies to overcome the challenges identified under paragraph (1), including strategies to support the most promising areas of food allergy research that could lead to alternatives to current forms of disease management and identify allergens of emerging prevalence.</del>
- (b) Publication— The Secretary shall make the report under subsection (a) available on the internet website of the Department of Health and Human Services.