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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4958 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 4958
To amend the Federal Food, Drug, and Cosmetic Act to require
notification to the Food and Drug Administration prior to use of
substances as generally recognized as safe, reassessment of the safety
of certain substances marketed as generally recognized as safe, provide
resources for reviews and reassessments, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 12, 2025
Mr. Pallone introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require
notification to the Food and Drug Administration prior to use of
substances as generally recognized as safe, reassessment of the safety
of certain substances marketed as generally recognized as safe, provide
resources for reviews and reassessments, and for other purposes.
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 ``Grocery Reform And Safety Act'' or
the ``GRAS Act''.
SEC. 2. REMOVAL OF GRAS EXEMPTION FROM FOOD ADDITIVE DEFINITION.
(a) In General.--Section 201(s) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(s)) is amended--
(1) by redesignating subparagraphs (1) through (6) as
clauses (A) through (G), respectively;
(2) by striking ``The term `food additive''' and inserting
``(1) The term `food additive''';
(3) by striking ``, if such substance is'' and all that
follows through ``of its intended use;'' and inserting ``,
including a substance that is generally recognized as safe,'';
and
(4) by adding at the end the following:
``(2) The term `generally recognized as safe' means, with respect
to a substance used in food as described in subparagraph (1), that such
substance is 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.''.
(b) Conforming Amendment.--Section 408(k)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a(k)(2)) is amended by striking
``section 201(s)(4)'' and inserting ``section 201(s)(1)(D)''.
SEC. 3. GRAS NOTIFICATIONS.
Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
348) is amended--
(1) in subsection (a)--
(A) in paragraph (2), by striking the ``or'' at the
end;
(B) in paragraph (3), by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(4) the food additive is generally recognized as safe,
and the procedural requirements of subsection (l) have been met
with respect to the food additive.''; and
(2) by adding at the end the following:
``(l) Notices Regarding Use of GRAS Substances.--
``(1) In general.--Any person that manufactures,
introduces, delivers for introduction, or receives a food
substance in interstate commerce that is intending to treat
such food substance as generally recognized as safe (in this
subsection referred to as `GRAS') shall, with respect to any
new use of such substance or use of a food substance that was
not marketed for use in foods in the United States before the
date of enactment of this subsection, submit to the Secretary a
notice prescribing the conditions under which such person
determined such substance is GRAS.
``(2) Required information.--A notice submitted 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
substance, used as the basis of the GRAS determination,
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 adequately
protective safety factors to ensure an appropriate
margin of safety to take into account uncertainties in
hazard identification, dose response, exposure, and
sensitivities;
``(E) information demonstrating the analysis that
the weight of the evidence shows that such substance
has not been found to be carcinogenic;
``(F) information demonstrating the analysis that
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 that forms the
recognition of safety as the Secretary may publicly
specify.
``(3) Form of notice.--A notice submitted under paragraph
(1) with respect to a food substance 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 regulations).
``(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
determination that the substance is GRAS under the conditions
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 supporting
data and information described in paragraph (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 conditions 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 paragraph (4)
or (5); or
``(ii) provide written notice to extend the
180-day period described in subparagraph (A)
for one additional 90-day period, as specified
in regulations.
``(B) Corrections.--The timeline set forth in
subparagraph (A) shall not be construed to limit the
authority of the Secretary to correct a statement of
the Secretary to not object to the determination that
the substance is GRAS if new evidence is subsequently
presented 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 supporting
data and information described in paragraph
(2), publicly available in a single 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 paragraph (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
substances (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, considered generally
recognized as safe.
``(C) Color additives.
``(D) Prior-sanctioned substances (as described 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, introduces, 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 substance, updated
information on--
``(A) estimates of dietary exposure among the
United States population;
``(B) the cumulative effects of such substance;
``(C) hazard, dose response, and exposure;
``(D) the application of adequately protective
safety factors to ensure an appropriate margin of
safety to take into account uncertainties in hazard
identification, dose response, exposure, and
sensitivities;
``(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 Secretary may
specify in regulation.
``(3) Revoking statement to not object.--If the Secretary
determines, with respect to a substance described in paragraph
(1)(B), based on information received under paragraph (2) and
publicly available information, that a concern about the safety
of the substance, or the intended use of the substance, exists,
the Secretary--
``(A) may revoke a written statement previously
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 location on
the website of the Food and Drug Administration
referred to in subsection (l)(7).
``(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 marketed 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 substance has been found--
``(A) to induce cancer when ingested by humans or
animals; or
``(B) after evaluation through appropriate testing
methods, by research or assessment conducted 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 pharmacological effects.
``(3) Conflict of interest.--The term `conflict of
interest' means a personal or financial interest that could
potentially compromise the professional judgment or objectivity
of an individual in designing, conducting, reporting, or
reviewing research or the applicability of research,
potentially undermining the integrity of such research.
``(4) Cumulative effects.--The term `cumulative effects'
means, with respect to a substance, the combined health effects
of all chemically or pharmacologically-related substances.
``(5) Developmental toxicity.--The term `developmental
toxicity' means, with respect to the effect of exposure to a
substance on a human or animal, 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 intended 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 recognized as
safe before, on, and after the date of enactment of
this subsection;
``(B) a use of a substance treated as generally
recognized as safe under subsection (l); or
``(C) a use of a prior-sanctioned substance (as
described in subparagraph (D) of section 201(s)(1)).
``(8) Reproductive toxicity.--The term `reproductive
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
system, 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)--
(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 submitting a
notice with respect to a food additive, for purposes of
issuing regulations or reviewing notices under section
409 prescribing the conditions under which such food
additive may be safely used; and
``(F) each person that manufactures, introduces,
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 period
at the end and inserting ``; and''; and
(iii) by adding at the end the following:
``(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 ``fiscal year
2009'' and inserting ``fiscal year 2025''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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