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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2341 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 2341
To amend the Federal Food, Drug, and Cosmetic Act to impose
requirements for substances generally recognized as safe, to require
the Commissioner of Food and Drugs to reassess the safety of chemicals
added to food, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 17, 2025
Mr. Markey (for himself, Mr. Booker, Ms. Warren, and Mr. Blumenthal)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to impose
requirements for substances generally recognized as safe, to require
the Commissioner of Food and Drugs to reassess the safety of chemicals
added to food, 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 ``Ensuring Safe and Toxic-Free Foods
Act of 2025''.
SEC. 2. SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act is amended by inserting after section 409 (21 U.S.C. 348) the
following:
``SEC. 409A. SUBSTANCES GENERALLY RECOGNIZED AS SAFE.
``(a) In General.--Any substance the intended use of which results
or may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristics of any
food (including any substance intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food; and including any source of radiation
intended for any such use), shall, with respect to any particular use
or intended use, be deemed to be unsafe for the purposes of the
application of clause (2)(C) of section 402(a), unless--
``(1) such substance is a food additive in compliance with
section 409;
``(2) subject to subsection (e)(2), the manufacturer has
submitted, prior to the date of enactment of the Ensuring Safe
and Toxic-Free Foods Act of 2025, a notice to the Secretary
that the manufacturer has concluded that such substance is
generally recognized as safe under the conditions of its
intended use, and the Secretary has not issued a response or
has issued a response stating that the Secretary does not
question the basis for such conclusion; or
``(3)(A) the manufacturer has submitted, during the period
beginning on the date of enactment of the Ensuring Safe and
Toxic-Free Foods Act of 2025 and ending on the day before the
effective date described in section 2(d) of such Act, a notice
to the Secretary that the manufacturer has determined such
substance to be generally recognized as safe under the
conditions of its intended use;
``(B) such notice includes supporting information
sufficient to justify the basis of such determination,
including full reports of investigations made with respect to
the safety for use of such substance, including--
``(i) full information as to the methods and
controls used in conducting such investigations;
``(ii) information on the cumulative effects of
such substance;
``(iii) information on hazard, dose response, and
exposure;
``(iv) 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;
``(v) information demonstrating that the weight of
the evidence analysis shows that such substance has not
been found to be carcinogenic; and
``(vi) information demonstrating that the weight of
the evidence analysis 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
``(C) the Secretary has not objected to such determination
under subsection (c).
``(b) Public Availability and Comment.--On receipt of a notice of a
determination described in subsection (a)(3)(A), the Secretary shall--
``(1) make such notice and the supporting information
included with such notice publicly available on the website of
the Food and Drug Administration; and
``(2) provide an opportunity for public comment for a
period of not less than 60 days.
``(c) Determination of Secretary.--
``(1) In general.--The Secretary shall issue a written
statement objecting to a determination described in subsection
(a)(3)(A) if 1 or more of the criteria described in paragraph
(2) are not met.
``(2) Criteria.--The criteria described in this paragraph
are the following:
``(A) The manufacturer has submitted complete
documentation justifying the basis for its
determination as described in subsection (a)(3)(B).
``(B) With respect to data used for such
justification that was provided by an expert, such
expert does not have a conflict of interest.
``(C) The available evidence adequately supports a
determination that the substance is generally
recognized as safe under the conditions of its intended
use.
``(3) Determination not to object.--With respect to a
determination described in subsection (a)(3)(A), if the
Secretary determines that all of the criteria described in
paragraph (2) are met, the Secretary shall issue a written
statement that the Secretary is not objecting to such
determination described in subsection (a)(3)(A).
``(4) Additional information.--Before objecting to a
determination described in subsection (a)(3)(A), the Secretary
may request additional information from the manufacturer if the
Secretary determines the manufacturer has failed to submit
complete documentation justifying the basis for its
determination as described in subsection (a)(3)(B).
``(5) Final agency action.--The determination of the
Secretary to object or not to object under this subsection to a
determination described in subsection (a)(3)(A) shall be
considered to be a final agency action.
``(6) Publication.--The Secretary shall publish the basis
of a determination to object or to not object under this
subsection to a determination described in subsection (a)(3)(A)
on the website of the Food and Drug Administration, including
any chemistry and toxicology memoranda produced or relied on by
the Secretary in making such determination. Failure to publish
such a determination shall not be construed as an affirmative
finding by the Secretary that the substance is generally
recognized as safe.
``(7) Definition of conflict of interest.--In this
subsection, the term `conflict of interest' means a 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.
``(d) Standards for Experts Evaluating Whether a Substance Is
GRAS.--Not later than 180 days after the date of enactment of the
Ensuring Safe and Toxic-Free Foods Act of 2025, the Secretary shall
issue guidance to strengthen the recommendations contained in the
December 2022 guidance of the Food and Drug Administration entitled
`Best Practices for Convening a GRAS Panel'.
``(e) Reassessment.--
``(1) In general.--With respect to a substance for which
the Secretary has determined under subsection (c)(3) not to
object to the manufacturer's determination under subsection
(a)(3)(A) that such substance is generally recognized as safe
under the conditions of its intended use, the Secretary may, at
any time--
``(A) reassess in accordance with subsection (c)
whether such substance is generally recognized as safe
under the conditions of its intended use; and
``(B) pursuant to such reassessment, withdraw the
determination of the Secretary not to object under
subsection (c)(3).
``(2) Prior submissions to gras notification program.--The
Secretary may require the manufacturer of a substance described
in subsection (a)(2) to submit a notice for such substance that
includes the information described in subsection (a)(3). The
Secretary shall review such notice in accordance with
subsections (b) and (c).
``(f) Timeline for Review of GRAS Submissions.--
``(1) In general.--The Secretary shall review not fewer
than 50 notices described in paragraphs (2) and (3) of
subsection (a) each year until all such notices have been
reviewed.
``(2) Requirements.--In conducting a review described in
paragraph (1), the Secretary shall--
``(A) with respect to a noticed described in
subsection (a)(2), issue a response to such notice
stating that, as applicable--
``(i) the Secretary does not question the
basis for such conclusion; or
``(ii) the Secretary has concluded that
such notice does not provide a sufficient basis
for such conclusion; and
``(B) with respect to a notice described in
subsection (a)(3), issue a response in accordance with,
as applicable, paragraph (1) or (3) of subsection (c).
``(g) Definitions.--In this section:
``(1) Carcinogenic.--
``(A) In general.--The term `carcinogenic', with
respect to a substance, means such substance is found
to induce cancer when ingested by humans or animals, or
is found, after tests that are appropriate for the
evaluation of the safety of substances, to induce
cancer in humans or animals.
``(B) Requirement.--In determining whether a
substance is carcinogenic for purposes of subparagraph
(A), the Secretary shall consider assessments conducted
by authoritative bodies, including the National
Toxicology Program, the International Agency for
Research on Cancer, and the Environmental Protection
Agency.
``(2) Cumulative effects.--The term `cumulative effects',
with respect to a substance, means the combined health effects
of all chemically or pharmacologically related substances.
``(3) Developmental toxicity.--The term `developmental
toxicity', with respect to the effect of exposure to a
substance on a human or animal, means 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.
``(4) Generally recognized as safe.--
``(A) In general.--The term `generally recognized
as safe', with respect to a substance, means 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) Exclusions.--The term `generally recognized
as safe', with respect to a substance, does not include
a substance that--
``(i) is carcinogenic;
``(ii) shows evidence of reproductive
toxicity or developmental toxicity;
``(iii) is otherwise identified as toxic by
the National Toxicology Program, the
Environmental Protection Agency, the Agency for
Toxic Substances and Disease Registry, or the
California Office of Environmental Health
Hazard Assessment;
``(iv) was not marketed for use in foods in
the United States prior to the date of
enactment of the Ensuring Safe and Toxic-Free
Foods Act of 2025; or
``(v) was not synthesized, characterized,
or isolated prior to the date of enactment of
the Ensuring Safe and Toxic-Free Foods Act of
2025.
``(5) Reproductive toxicity.--The term `reproductive
toxicity', with respect to the effect of exposure to a
substance on a human or animal, means 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.
``(h) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as are necessary.''.
(b) Adulteration.--Section 402(a)(2)(C)(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)(i)) is amended by
inserting ``or any other substance that is not generally recognized as
safe in compliance with section 409A'' after ``section 409''.
(c) Definitions.--Section 201(s) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(s)) is amended--
(1) by striking ``if such substance is not 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;'';
(2) in paragraph (5), by striking ``or'' at the end;
(3) in paragraph (6), by striking the period and inserting
``; or''; and
(4) by adding at the end the following:
``(7) a substance generally recognized as safe in
compliance with section 409A.''.
(d) Effective Date.--The amendments made by this section shall take
effect on the date that is 2 years after the date of enactment of this
Act.
SEC. 3. FOOD CHEMICAL REASSESSMENT.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended by inserting after section 409A (as added by
section 2(a)) the following:
``SEC. 409B. FOOD CHEMICAL REASSESSMENT.
``(a) Safety Reassessments.--
``(1) In general.--Not later than 3 years after the date of
enactment of this section, and not less frequently than once
every 3 years thereafter, the Secretary shall reassess the
safety, within the meaning of section 409 or section 409A, of
not less than 10 substances or classes of substances--
``(A) to determine if such substance or class of
substances is safe within the meaning of section 409 or
section 409A; and
``(B) to establish the conditions of use, if any,
under which any such substance or class of substances
may be used safely within the meaning of such section
409 or 409A.
``(2) Requirements for manufacturers.--The Secretary may
require any manufacturer of a substance or class of substances
that is being reassessed under paragraph (1) to provide data or
to conduct evaluations of such substance or class of substances
for purposes of the reassessment under paragraph (1).
``(3) Priority.--The Secretary may give priority to the
reassessment of a substance or class of substances that is the
subject of--
``(A) a food additive petition under section
409(b);
``(B) a color additive petition under section
721(d); or
``(C) a citizen petition to request the
reassessment, restriction, or revocation of an existing
authorization of such substance or class of substances.
``(b) Considerations.--In determining, for the purposes of this
section, whether a substance or class of substances is unsafe within
the meaning of section 409 or section 409A, the Secretary shall
consider the information described in clauses (i) through (vi) of
section 409A(a)(3)(B).
``(c) Rule of Construction.--Nothing in this section alters the
authority or duties of the Secretary with respect to the administration
and enforcement of section 409 or section 409A.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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