GRAS Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4958 Introduced in House (IH)]

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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''.
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