not marketed for use in foods in the United States 
before the date of enactment of this subsection, sub-
mit to the Secretary a notice prescribing the condi-
tions under which such person determined such sub-
stance is GRAS. 
‘‘(2) REQUIRED INFORMATION.—A notice sub-
mitted under paragraph (1) with respect to a food 
substance shall include publicly available supporting 
data and information sufficient to demonstrate the 
identity and composition, the manufacturing process, 
the intended effect, and the safety of the food sub-
stance, used as the basis of the GRAS determina-
tion, including full reports of investigations made 
with respect to the safety for use of such substance, 
including— 
‘‘(A) information as to the methods and 
controls used in conducting such investigations; 
‘‘(B) information on the cumulative effects 
of such substance; 
‘‘(C) information on hazard, dose response, 
and exposure; 
‘‘(D) information on the application of ade-
quately protective safety factors to ensure an 
appropriate margin of safety to take into ac-
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count uncertainties in hazard identification, 
dose response, exposure, and sensitivities; 
‘‘(E) information demonstrating the anal-
ysis that the weight of the evidence shows that 
such substance has not been found to be car-
cinogenic; 
‘‘(F) information demonstrating the anal-
ysis that the weight of the evidence shows that 
such substance has not been found to induce re-
productive toxicity or developmental toxicity in 
humans or animals, including through an endo-
crine mode of action; and 
‘‘(G) such other information that forms the 
recognition of safety as the Secretary may pub-
licly specify. 
‘‘(3) FORM
OF
NOTICE.—A notice submitted 
under paragraph (1) with respect to a food sub-
stance shall be submitted in such form and manner 
as specified in subpart E of part 170 of title 21, 
Code of Federal Regulations (or successor regula-
tions). 
‘‘(4) STATEMENT NOT TO OBJECT TO USE.—A 
person may use a substance subject to a notice 
under paragraph (1) only if the Secretary has issued 
a written statement to not object to the determina-
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tion that the substance is GRAS under the condi-
tions prescribed in the notice. 
‘‘(5) STATEMENT TO OBJECT.—The Secretary 
shall issue a written statement objecting to use of a 
substance subject to a notice under paragraph (1) if 
the Secretary determines that— 
‘‘(A) the notice does not contain the sup-
porting data and information described in para-
graph (2); 
‘‘(B) with respect to any such supporting 
data and information that was provided by an 
expert, such expert appears to have a conflict of 
interest, as determined pursuant to guidance 
issued by the Secretary; or 
‘‘(C) such supporting data and information 
does not adequately support a determination 
that the substance is GRAS under the condi-
tions prescribed in the notice. 
‘‘(6) DETERMINATION TIMELINE.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) not later than 180 days after the 
acceptance of a notice under paragraph 
(1), issue a written statement under para-
graph (4) or (5); or 
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‘‘(ii) provide written notice to extend 
the 180-day period described in subpara-
graph (A) for one additional 90-day period, 
as specified in regulations. 
‘‘(B) CORRECTIONS.—The timeline set 
forth in subparagraph (A) shall not be con-
strued to limit the authority of the Secretary to 
correct a statement of the Secretary to not ob-
ject to the determination that the substance is 
GRAS if new evidence is subsequently pre-
sented or discovered. 
‘‘(7) PUBLIC AVAILABILITY AND COMMENT.— 
The Secretary shall— 
‘‘(A) upon acceptance of a notice under 
paragraph (1)— 
‘‘(i) make such notice, and the sup-
porting data and information described in 
paragraph (2), publicly available in a sin-
gle location on the website of the Food and 
Drug Administration; and 
‘‘(ii) provide an opportunity for public 
comment for a period of not less than 60 
days; and 
‘‘(B) upon close of the comment period, 
make any written statement issued under para-
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graph (4) or (5) publicly available in the same 
location. 
‘‘(8) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated such sums as 
may be necessary to carry out this subsection.’’. 
SEC. 4. REASSESSMENTS. 
Section 409 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 348), as amended by section 3, is further 
amended by adding at the end the following: 
‘‘(m) REASSESSMENTS.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of this subsection, and 
at least every 3 years thereafter, the Secretary shall 
systematically reassess the safety (including the 
safety of conditions of use), within the meaning of 
section 409, of at least 10 of the following sub-
stances (or classes thereof): 
‘‘(A) Food additives marketed pursuant to 
an order under subsection (c). 
‘‘(B) Any substance which was, before the 
date of the enactment of this subsection, con-
sidered generally recognized as safe. 
‘‘(C) Color additives. 
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‘‘(D) Prior-sanctioned substances (as de-
scribed 
in 
subparagraph 
(D) 
of 
section 
201(s)(1)). 
‘‘(E) Food contact substances. 
‘‘(2) SAFETY EVALUATIONS.—In conducting the 
reassessments under this subsection, the Secretary 
may require any person that manufactures, intro-
duces, delivers for introduction, or receives a food 
substance described in paragraph (1) in interstate 
commerce to conduct, and submit to the Secretary, 
safety evaluations of such substance. Such a safety 
evaluation shall include, with respect to such sub-
stance, updated information on— 
‘‘(A) estimates of dietary exposure among 
the United States population; 
‘‘(B) the cumulative effects of such sub-
stance; 
‘‘(C) hazard, dose response, and exposure; 
‘‘(D) the application of adequately protec-
tive safety factors to ensure an appropriate 
margin of safety to take into account uncertain-
ties in hazard identification, dose response, ex-
posure, and sensitivities; 
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‘‘(E) whether the weight of the evidence 
shows that such substance has not been found 
to be carcinogenic; 
‘‘(F) whether the weight of the evidence 
shows that such substance has not been found 
to induce reproductive toxicity or developmental 
toxicity in humans or animals, including 
through an endocrine mode of action; and 
‘‘(G) such other information as the Sec-
retary may specify in regulation. 
‘‘(3) REVOKING STATEMENT TO NOT OBJECT.— 
If the Secretary determines, with respect to a sub-
stance described in paragraph (1)(B), based on in-
formation received under paragraph (2) and publicly 
available information, that a concern about the safe-
ty of the substance, or the intended use of the sub-
stance, exists, the Secretary— 
‘‘(A) may revoke a written statement pre-
viously issued by the Secretary to not object to 
a determination that the substance is generally 
recognized as safe; and 
‘‘(B) shall post such revocation in the loca-
tion on the website of the Food and Drug Ad-
ministration referred to in subsection (l)(7). 
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‘‘(4) NOTICES OF SUBSTANCES MARKETED AS 
GRAS.—The Secretary may require a person that 
manufactures, introduces, delivers for introduction, 
or receives a food substance described in paragraph 
(1) in interstate commerce that was marketed as 
generally recognized as safe before, on, and after the 
date of enactment of this subsection to submit to the 
Secretary a notification that such person so mar-
keted the substance as generally recognized as safe. 
‘‘(5) CIVIL MONETARY PENALTIES.—In the case 
of a violation of this subsection, the Secretary shall 
assess a civil penalty in accordance with section 307. 
‘‘(6) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated such sums as 
may be necessary to carry out this subsection.’’. 
SEC. 5. DEFINITIONS. 
(a) IN GENERAL.—Section 409 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348), as amended by 
sections 3 and 4, is further amended by adding at the end 
the following: 
‘‘(n) DEFINITIONS.—In this section: 
‘‘(1) CARCINOGENIC.—The term ‘carcinogenic’ 
means, with respect to a substance, that such sub-
stance has been found— 
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‘‘(A) to induce cancer when ingested by 
humans or animals; or 
‘‘(B) after evaluation through appropriate 
testing methods, by research or assessment con-
ducted by an authoritative scientific body (such 
as the Environmental Protection Agency, the 
International Agency for Research on Cancer, 
or the National Toxicology Program), to induce 
cancer in humans or animals. 
‘‘(2) CLASS.—The term ‘class’, with respect to 
a substance, means a group of chemicals that are 
chemically similar or cause similar or related phar-
macological effects. 
‘‘(3) CONFLICT OF INTEREST.—The term ‘con-
flict of interest’ means a personal or financial inter-
est that could potentially compromise the profes-
sional judgment or objectivity of an individual in de-
signing, conducting, reporting, or reviewing research 
or the applicability of research, potentially under-
mining the integrity of such research. 
‘‘(4) CUMULATIVE EFFECTS.—The term ‘cumu-
lative effects’ means, with respect to a substance, 
the combined health effects of all chemically or phar-
macologically-related substances. 
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‘‘(5) DEVELOPMENTAL
TOXICITY.—The term 
‘developmental toxicity’ means, with respect to the 
effect of exposure to a substance on a human or ani-
mal, an adverse effect on the development of such 
human or animal that results from such exposure— 
‘‘(A) to the mother prior to conception of, 
or during the prenatal period for, such human 
or animal; or 
‘‘(B) to such human or animal before the 
time of sexual maturity. 
‘‘(6) FOOD
CONTACT
SUBSTANCE.—The term 
‘food contact substance’ means any substance in-
tended for use as a component of materials used in 
manufacturing, packing, packaging, transporting, or 
holding food if such use is not intended to have any 
technical effect in such food. 
‘‘(7) NEW USE.—The term ‘new use’ means a 
use other than— 
‘‘(A) a use of a substance generally recog-
nized as safe before, on, and after the date of 
enactment of this subsection; 
‘‘(B) a use of a substance treated as gen-
erally recognized as safe under subsection (l); 
or 
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‘‘(C) a use of a prior-sanctioned substance 
(as described in subparagraph (D) of section 
201(s)(1)). 
‘‘(8) REPRODUCTIVE TOXICITY.—The term ‘re-
productive toxicity’ means, with respect to the effect 
of exposure to a substance on a human or animal, 
an adverse effect on the reproductive system of such 
human or animal, which may include alterations to 
reproductive system development, the endocrine sys-
tem, fertility, pregnancy, pregnancy outcomes, or 
modifications in other functions that are dependent 
on the integrity of the reproductive system.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 201(q)(1)(B)(ii) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
321(q)(1)(B)(ii)) is amended by striking ‘‘section 
409(h)(6)’’ and inserting ‘‘section 409(n)’’. 
(2) Section 409(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 348(h)) is amended by 
striking paragraph (6). 
SEC. 6. FOOD ADDITIVE AND GRAS SUBSTANCE FEES. 
Section 743 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–31) is amended— 
(1) in subsection (a)(1)— 
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(A) in subparagraph (C), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (D), by striking the 
period at the end and inserting a semicolon; 
and 
(C) by adding at the end the following: 
‘‘(E) each person filing a petition or sub-
mitting a notice with respect to a food additive, 
for purposes of issuing regulations or reviewing 
notices under section 409 prescribing the condi-
tions under which such food additive may be 
safely used; and 
‘‘(F) each person that manufactures, intro-
duces, delivers for introduction, or receives a 
food substance in interstate commerce that is 
subject to a reassessment under subsection (m) 
of section 409, for purposes of conducting such 
reassessment.’’; 
(2) in subsection (b)— 
(A) in paragraph (2)(A)— 
(i) in clause (iii), by striking ‘‘and’’ at 
the end; 
(ii) in clause (iv), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
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(iii) by adding at the end the fol-
lowing: 
‘‘(v) under subparagraph (E) or (F) 
of subsection (a)(1) for a fiscal year shall 
be based on the Secretary’s estimate of 
100 percent of the costs of the activities 
described in such subparagraph (E) or (F) 
for such year.’’; and 
(B) in paragraph (3), by striking ‘‘clause 
(i), (ii), (iii), and (iv)’’ each place it appears 
and inserting ‘‘clause (i), (ii), (iii), (iv), and 
(v)’’; and 
(3) in subsection (c)— 
(A) in paragraph (1)— 
(i) by striking ‘‘fiscal year 2010’’ and 
inserting ‘‘fiscal year 2026’’; and 
(ii) by striking ‘‘fiscal year 2009’’ and 
inserting ‘‘fiscal year 2025’’; and 
(B) in paragraph (3)(B), by striking ‘‘fis-
cal year 2009’’ and inserting ‘‘fiscal year 
2025’’. 
Æ 
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