```

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 578 Engrossed in Senate (ES)]

<DOC>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
117th CONGRESS
  1st Session
                                 S. 578

_______________________________________________________________________

                                 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.

            Passed the Senate March 3, 2021.

            Attest:

                                                             Secretary.
117th CONGRESS

  1st Session

                                 S. 578

_______________________________________________________________________

                                 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.
```