119-hr4958

[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''.
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