(1) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall— 
(A) not later than 180 days after the date 
of enactment of this Act, publish a proposed re-
vision to the final rule titled ‘‘Substances Gen-
erally Recognized as Safe’’, published by the 
Food and Drug Administration on August 17, 
2016 (81 Federal Register 54960 et seq.); and 
(B) not later than 90 days after the close 
of the period for public comment on the revision 
proposed pursuant to subparagraph (A), pub-
lish a final revision to such final rule. 
(2) CONTENTS.—The revision required by para-
graph (1) shall include each of the following: 
(A) The revision shall prohibit a manufac-
turer from marketing a substance as GRAS, or 
manufacturing or selling food that contains a 
substance the manufacturer has determined to 
be GRAS, unless— 
(i) the Secretary has received notice 
that the manufacturer has determined 
such substance to be GRAS; and 
(ii) the manufacturer has provided the 
Secretary with supporting information suf-
VerDate Sep 11 2014 
04:53 Jun 26, 2021
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3699.IH
H3699
kjohnson on DSK79L0C42PROD with BILLS
ficient to understand the basis of the de-
termination, including, as required by the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.)— 
(I) the cumulative effects of the 
substance, as required under section 
409 of such Act (21 U.S.C. 348); 
(II) an adequately protective use 
of safety factors; and 
(III) application of a margin of 
safety to take into account the im-
pacts of exposures during critical win-
dows of development and on vulner-
able populations. 
(B) The revision shall require the Sec-
retary— 
(i) to make each determination that is 
submitted 
pursuant 
to 
subparagraph 
(A)(i), and the supporting information sub-
mitted pursuant to subparagraph (A)(ii), 
publicly available on the website of the 
Food and Drug Administration; and 
(ii) provide a period of at least 90 
days for the Secretary and the public to re-
view each such determination and object, if 
VerDate Sep 11 2014 
04:53 Jun 26, 2021
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3699.IH
H3699
kjohnson on DSK79L0C42PROD with BILLS
appropriate, in order to ensure that the 
substance involved is safe taking into ac-
count the factors in listed in section 
409(c)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 348(c)(5)). 
(C) The revision shall clarify that newly 
synthesized or novel chemical substances cannot 
be GRAS. 
(D) The revision shall clarify that carcino-
genic substances cannot be GRAS. 
(E) The revision shall— 
(i) prohibit the Secretary from relying 
on the determination of experts with con-
flicts of interest when determining a sub-
stance to be GRAS; and 
(ii) incorporate the recommendations 
in the draft guidance titled ‘‘Best Practices 
for Convening a GRAS Panel’’, issued by 
the Food and Drug Administration in No-
vember, 2017, and measures to strengthen 
the recommendations in such guidance. 
(F) The revision shall create a process that 
requires the Secretary to systematically reassess 
any substance that was determined to be GRAS 
VerDate Sep 11 2014 
04:53 Jun 26, 2021
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3699.IH
H3699
kjohnson on DSK79L0C42PROD with BILLS
if such determination did not meet the revised 
standards for such a determination. 
(b) FOOD ADVISORY COMMITTEE.—Not later than 
180 days after the date of enactment of this Act, the Sec-
retary shall— 
(1) reestablish the Food Advisory Committee to 
work with the Secretary on the reassessment stand-
ards, process, and methods necessary to complete 
the work described in subsection (a)(2)(F); and 
(2) provide such Committee with such staffing 
and resources as are necessary to complete such 
work. 
(c) DEFINITIONS.—In this subsection: 
(1) The term ‘‘GRAS’’ means, with respect to 
a substance, generally recognized, among experts 
qualified by scientific training and experience to 
evaluate its safety, as having been adequately shown 
through scientific procedures (or, in the case of a 
substance used in food prior to January 1, 1958, 
through either scientific procedures or experience 
based on common use in food) to be safe under the 
conditions of its intended use, as described in section 
201(s) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321). 
VerDate Sep 11 2014 
04:53 Jun 26, 2021
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3699.IH
H3699
kjohnson on DSK79L0C42PROD with BILLS
(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
Æ 
VerDate Sep 11 2014 
04:53 Jun 26, 2021
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6301
E:\BILLS\H3699.IH
H3699
kjohnson on DSK79L0C42PROD with BILLS