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Union Calendar No. 479 

116TH CONGRESS 

2D SESSION H. R. 2117 

[Report No. 116–581] 

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. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 8, 2019 

Ms. MATSUI introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

NOVEMBER 16, 2020 

Additional sponsors: Mr. ROSE of New York, Mrs. MURPHY of Florida, Mr. 

MCHENRY, Miss RICE of New York, Ms. KUSTER of New Hampshire, 

Mr. KHANNA, Mr. CONNOLLY, Mr. COOPER, Mr. GOTTHEIMER, Mr. 

BURCHETT, Ms. PINGREE, Mr. RASKIN, Mr. RYAN, Mr. FITZPATRICK, 

Ms. BARRAGA ́N, Mr. LEVIN of California, Mr. KATKO, Mrs. LURIA, Ms. 

SHERRILL, Mr. SUOZZI, Mr. VAN DREW, Ms. WILD, Mr. STIVERS, Mr. 

LAMB, Mr. HARDER of California, Ms. SCHAKOWSKY, Mr. BRENDAN F. 

BOYLE of Pennsylvania, Mr. CLINE, Mr. BRINDISI, Ms. STEFANIK, Mr. 

HIMES, Ms. DEAN, Ms. BLUNT ROCHESTER, Mr. MCGOVERN, Mr. 

CUNNINGHAM, Mr. JOYCE of Ohio, Mr. UPTON, Mrs. DINGELL, Mr. 

POCAN, Mr. COX of California, Ms. SPANBERGER, Mrs. AXNE, Mr. 

STEIL, Mrs. KIRKPATRICK, Mr. PERLMUTTER, Ms. JACKSON LEE, Mr. 

NEGUSE, Mr. LIPINSKI, Mr. MALINOWSKI, Mrs. HAYES, Ms. VELA ́ZQUEZ, 

Mr. GALLAGHER, Mr. REED, Mr. PETERS, Mr. CARBAJAL, Mr. 

O’HALLERAN, Mr. NADLER, Ms. TORRES SMALL of New Mexico, Mr. 

MCADAMS, Ms. STEVENS, Mrs. CAROLYN B. MALONEY of New York, Mr. 

SCHNEIDER, Mr. NORCROSS, Mr. CISNEROS, Ms. NORTON, Mr. 

DELGADO, Mr. PANETTA, Mr. RIGGLEMAN, Mr. STAUBER, Mr. LANGEVIN, Mr. AMODEI, Mr. JOHNSON of South Dakota, Mr. JOHNSON of 

Ohio, Mr. CASTEN of Illinois, Mr. BACON, Mrs. TRAHAN, Mr. KEATING, 

Ms. JAYAPAL, Mr. SEAN PATRICK MALONEY of New York, Mr. 

HORSFORD, Mrs. BROOKS of Indiana, Mr. MITCHELL, Mr. MEUSER, Mr. 


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GONZALEZ of Ohio, Mr. HURD of Texas, Mr. THOMPSON of Pennsylvania, Mr. WITTMAN, Mr. LEVIN of Michigan, Mr. CICILLINE, Ms. 

BROWNLEY of California, Mr. PAPPAS, Mr. VARGAS, and Mr. TAYLOR

NOVEMBER 16, 2020 

Reported with an amendment; committed to the Committee of the Whole 

House on the State of the Union and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on April 8, 2019] 

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. 


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•HR 2117 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Allergy Safety, 

5 Treatment, Education, and Research Act of 2020’’ or the 

6 ‘‘FASTER Act of 2020’’. 

7 SEC. 2. FOOD ALLERGY SAFETY RECOMMENDATIONS OF 

8 THE NATIONAL ACADEMY OF MEDICINE. 

9 (a) COLLECTION OF FOOD ALLERGY DATA.—The Pub10 lic Health Service Act is amended by inserting before sec11 tion 318 of such Act (42 U.S.C. 247c) the following new 

12 section: 

13 ‘‘SEC. 317W. COLLECTION OF FOOD ALLERGY DATA. 

14 ‘‘(a) IN GENERAL.—The Secretary, acting through the 

15 Director of the Centers for Disease Control and Prevention, 

16 shall— 

17 ‘‘(1) expand and intensify the collection of infor18 mation on the prevalence of food allergies for specific 

19 allergens in the United States, such as through the 

20 National Health and Nutrition Examination Survey 

21 and the National Health Interview Survey; 

22 ‘‘(2) include such information within annual or 

23 other periodic reporting to the Congress and the pub24 lic on other surveillance activities; and 


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1 ‘‘(3) encourage research to improve the accuracy 

2 of food allergy prevalence data. 

3 ‘‘(b) BIOMARKERS.—Any research conducted pursuant 

4 to subsection (a)(3) shall include— 

5 ‘‘(1) the identification of biomarkers and tests to 

6 validate data generated from such research; and 

7 ‘‘(2) the investigation of the use of identified bio8 markers and tests in national surveys conducted as 

9 part of that research.’’. 

10 (b) ALLERGEN LABELING.— 

11 (1) MAJOR FOOD ALLERGEN DEFINITION.— 

12 (A) IN GENERAL.—Section 201(qq)(1) of the 

13 Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 321(qq)(1)) is amended by striking ‘‘and 

15 soybeans’’ and inserting ‘‘soybeans, and sesame’’. 

16 (B) EFFECTIVE DATE.—The amendment 

17 made by subparagraph (A) shall apply with re18 spect to food introduced or delivered for intro19 duction into interstate commerce on or after 

20 January 1, 2022. 

21 (2) ADDITIONAL ALLERGENS.—Section 201(qq) 

22 of the Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 321(qq)) is amended by adding at the end the 

24 following: 


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1 ‘‘(3) Any other food ingredient that the Secretary 

2 determines by regulation to be a major food allergen, 

3 based on the scientific criteria determined by the Sec4 retary (including the prevalence and severity of aller5 gic reactions to the food ingredient) that establish that 

6 such food ingredient is an allergen of public health 

7 concern.’’. 

8 (3) TECHNICAL CORRECTIONS.—Section 

9 201(qq)(2) of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 321(qq)(2)) is amended by striking 

11 ‘‘paragraph’’ each place it appears and inserting 

12 ‘‘subparagraph’’. 

13 SEC. 3. REPORT ON USE BY FDA OF PATIENT EXPERIENCE 

14 DATA ON TREATMENTS FOR PATIENTS WITH 

15 FOOD ALLERGIES. 

16 Section 3004 of the 21st Century Cures Act (21 U.S.C. 

17 355 note) is amended— 

18 (1) by striking ‘‘Not later than’’ and inserting 

19 the following: 

20 ‘‘(a) IN GENERAL.—Not later than’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(b) TREATMENTS FOR PATIENTS WITH FOOD ALLER23 GIES.—Each report under subsection (a) shall include a 

24 synopsis of the use by the Food and Drug Administration 

25 in regulatory decisionmaking of patient experience data on 


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1 products with an indication for the treatment of a food al2 lergy.’’. 


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pamtmann on DSKBC07HB2PROD with BILLS
Union Calendar No. 479 

116TH CONGRESS 

2D SESSION H. R. 2117 

[Report No. 116–581] 

A BILL 

To improve the health and safety of Americans livother purposes. eosinophilic gastrointestinal diseases, and for food protein-induced enterocolitis syndrome, and cluding potentially life-threatening anaphylaxis, ing with food allergies and related disorders, inNOVEMBER 16, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


pamtmann on DSKBC07HB2PROD with BILLS