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Food Allergy Safety, Treatment, Education, and Research Act of 2020

Floor Speech

Date: Nov. 17, 2020
Location: Washington, DC

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Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2117) 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, as amended.

The Clerk read the title of the bill.

The text of the bill is as follows: H.R. 2117

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 RECOMMENDATIONS OF THE NATIONAL ACADEMY OF MEDICINE.

(a) Collection of Food Allergy Data.--The Public Health Service Act is amended by inserting before section 318 of such Act (42 U.S.C. 247c) the following new section: ``SEC. 317W. COLLECTION OF FOOD ALLERGY DATA.

``(a) In General.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall--

``(1) expand and intensify the collection of information on the prevalence of food allergies for specific allergens in the United States, such as through the National Health and Nutrition Examination Survey and the National Health Interview Survey;

``(2) include such information within annual or other periodic reporting to the Congress and the public on other surveillance activities; and

``(3) encourage research to improve the accuracy of food allergy prevalence data.

``(b) Biomarkers.--Any research conducted pursuant to subsection (a)(3) shall include--

``(1) the identification of biomarkers and tests to validate data generated from such research; and

``(2) the investigation of the use of identified biomarkers and tests in national surveys conducted as part of that research.''.

(b) Allergen Labeling.--

(1) Major food allergen definition.--

(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 subparagraph (A) shall apply with respect to food introduced or delivered for introduction into interstate commerce on or after January 1, 2022.

(2) Additional allergens.--Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is amended by adding at the end the following:

``(3) Any other food ingredient that the Secretary determines by regulation to be a major food allergen, based on the scientific criteria determined by the Secretary (including the prevalence and severity of allergic reactions to the food ingredient) that establish that such food ingredient is an allergen of public health concern.''.

(3) Technical corrections.--Section 201(qq)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(2)) is amended by striking ``paragraph'' each place it appears and inserting ``subparagraph''. SEC. 3. REPORT ON USE BY FDA OF PATIENT EXPERIENCE DATA ON TREATMENTS FOR PATIENTS WITH FOOD ALLERGIES.

Section 3004 of the 21st Century Cures Act (21 U.S.C. 355 note) is amended--

(1) by striking ``Not later than'' and inserting the following:

``(a) In General.--Not later than''; and

(2) by adding at the end the following:

``(b) Treatments for Patients With Food Allergies.--Each report under subsection (a) shall include a synopsis of the use by the Food and Drug Administration in regulatory decisionmaking of patient experience data on products with an indication for the treatment of a food allergy.''.

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Mr. PALLONE. 2117.

Mr. Speaker, I rise today in support of H.R. 2117, the Food Allergy Safety, Treatment, Education, and Research Act, or the FASTER Act.

Mr. Speaker, an estimated 32 million Americans, including approximately 1 in every 13 children, are affected by food allergies. These allergies pose risks to millions of families, and these risks grow dramatically when inaccurate labels fail to warn consumers about the presence of some of these allergens.

Under current law, eight allergens are considered major food allergens. They include milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. Due to their status as major food allergens, manufacturers must clearly state the presence of any of these ingredients on labels.

Notably missing from this list of allergens is sesame. That is concerning, considering it is an allergen of growing concern and its inclusion in food products has more than doubled over the last decade. In some cases, sesame may not be listed at all on ingredient labels, being referred to instead through nonspecific terms like ``flavors'' or words that may not easily be recognized by consumers as containing sesame, such as tahini.

While it may seem like a small issue to some, this lack of information could mean life or death for those who are allergic to sesame. Clearly, this information should be prominently featured on packaged food labels.

This is an issue we have been working on for quite some time. Several years ago, I introduced a bill that would list sesame as a major food allergen, and although the Food and Drug Administration opened a docket to solicit feedback about the sesame labeling and recently released guidance recommending voluntary labeling of sesame, the agency has not been able to require the listing of sesame due to overly long regulatory processes.

As we learn more about food allergens, our regulations should be able to adapt to align with the latest science. This process should not take years. Families should have reliable access to this information, and they should have it now.

Today we are taking action, Mr. Speaker. The appropriately named FASTER Act would quickly move this process along by recognizing sesame as a major food allergen, requiring its listing on new food labels after a phase-in process.

Importantly, the bill would also streamline processes at FDA to allow for additional allergens to be listed as major food allergens based on scientific criteria, including the prevalence and the severity of the allergens.

The bill would also help develop quality research into food allergens by directing the Centers for Disease Control and Prevention to expand and intensify its collection of data on food allergens and by directing FDA to report on its use of patient experience data.

I want to thank Representative Matsui for her tireless efforts in support of families affected by food allergens and for introducing this bill.

I am a strong supporter of the bill, and I encourage all Members to support it.

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Mr. PALLONE. Matsui), the sponsor of the legislation.

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Mr. PALLONE. Mr. Speaker, I ask my colleagues to support this legislation, and I yield back the balance of my time.

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