IB 
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 gastro-
intestinal 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. LAN-
GEVIN, 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. 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6652
E:\BILLS\H2117.RH
H2117
pamtmann on DSKBC07HB2PROD with BILLS
GONZALEZ of Ohio, Mr. HURD of Texas, Mr. THOMPSON of Pennsyl-
vania, 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. 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6652
E:\BILLS\H2117.RH
H2117
pamtmann on DSKBC07HB2PROD with BILLS
Be it enacted by the Senate and House of Representa-
tives 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 Pub-
lic Health Service Act is amended by inserting before sec-
tion 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 infor-
mation 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 pub-
lic on other surveillance activities; and 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6203
E:\BILLS\H2117.RH
H2117
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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 bio-
markers 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 re-
spect to food introduced or delivered for intro-
duction 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: 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6203
E:\BILLS\H2117.RH
H2117
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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 Sec-
retary (including the prevalence and severity of aller-
gic 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 ALLER-
GIES.—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 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6203
E:\BILLS\H2117.RH
H2117
pamtmann on DSKBC07HB2PROD with BILLS
products with an indication for the treatment of a food al-
lergy.’’. 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6203
E:\BILLS\H2117.RH
H2117
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 liv-
ing with food allergies and related disorders, in-
cluding potentially life-threatening anaphylaxis, 
food protein-induced enterocolitis syndrome, and 
eosinophilic gastrointestinal diseases, and for 
other purposes. 
NOVEMBER 16, 2020 
Reported with an amendment; committed to the Com-
mittee of the Whole House on the State of the Union 
and ordered to be printed 
VerDate Sep 11 2014 
04:10 Nov 17, 2020
Jkt 019200
PO 00000
Frm 00008
Fmt 6651
Sfmt 6651
E:\BILLS\H2117.RH
H2117
pamtmann on DSKBC07HB2PROD with BILLS