[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3387 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 3387
To direct the Secretary of Health and Human Services to update and
clarify its rule on substances generally recognized as safe and to
establish within the Food and Drug Administration the Office of Food
Chemical Safety, Dietary Supplements, and Innovation, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 4, 2023
Mr. Markey (for himself, Mr. Booker, Mr. Blumenthal, and Ms. Warren)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to update and
clarify its rule on substances generally recognized as safe and to
establish within the Food and Drug Administration the Office of Food
Chemical Safety, Dietary Supplements, and Innovation, 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 2023''.
SEC. 2. DIRECTED RULEMAKING REGARDING SUBSTANCES GENERALLY RECOGNIZED
AS SAFE.
(a) Definitions.--In this section:
(1) GRAS.--The term ``GRAS'', with respect to the use of a
substance in food, has the meaning given the term ``generally
recognized as safe for use in food'' in section 409A(a) of the
Federal Food, Drug, and Cosmetic Act, as added by section 3.
(2) Reproductive or developmental toxicity.--The term
``reproductive or developmental toxicity'' has the meaning
given such term in such section 409A(a).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs.
(4) Vulnerable human populations.--The term ``vulnerable
human population'' has the meaning given such term in such
section 409A(a).
(b) Directed Rulemaking.--
(1) In general.--The Secretary shall--
(A) not later than 1 year after the date of
enactment of this Act, publish a proposed revision to
the final rule titled ``Substances Generally Recognized
as Safe'', published by the Food and Drug
Administration on August 17, 2016 (81 Fed. Reg. 54960);
(B) not later than 180 days after the close of the
period for public comment on the revision proposed
under subparagraph (A), publish a final revision to
such final rule; and
(C) not later than 180 days after the date of
enactment of this Act, publish a plan for monitoring
industry compliance with the rules, regulations, and
guidance of the Food and Drug Administration relating
to GRAS, including the December 2022 guidance titled
``Best Practices for Convening a GRAS Panel''.
(2) Contents.--The revision required by subparagraphs (A)
and (B) of paragraph (1) shall include each of the following:
(A) The revision shall prohibit a manufacturer from
marketing a substance as GRAS, or manufacturing or
selling food that contains a substance the manufacturer
has determined to be GRAS, unless--
(i) the Secretary has made a final
determination, which is conveyed to the
manufacturer in writing, that the Secretary has
received sufficient notice from the
manufacturer that the manufacturer has
determined such substance to be GRAS under the
conditions of its intended use; and
(ii) the manufacturer has provided the
Secretary with supporting information
sufficient to understand the basis of the
determination, including--
(I) the cumulative effects of the
substance, as required under section
409 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348);
(II) an adequately protective use
of safety factors, as described under
such section 409, including safety
factors to account for the particular
sensitivities of vulnerable human
populations, to the extent that data
are available to derive safety factors
for each vulnerable human population;
(III) information demonstrating
that the weight of evidence analysis
shows the substance has not been found
to induce cancer when ingested by
humans or animals; and
(IV) information demonstrating that
the weight of evidence analysis shows
the substance has not been found to
induce reproductive or developmental
toxicity when ingested by humans or
animals, including through an endocrine
mode of action.
(B) The revision shall require--
(i) the Secretary to make each
determination that is submitted pursuant to
subparagraph (A)(i), and the supporting
information submitted pursuant to subparagraph
(A)(ii), publicly available on the website of
the Food and Drug Administration;
(ii) a period of at least 90 days for the
Secretary and the public to review each such
determination and object, if appropriate, in
order to ensure that the substance involved is
safe taking into account the factors listed in
subparagraph (A) and in paragraphs (3) through
(5) of section 409(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(c)); and
(iii) the Secretary's objection, or
decision not to object, to be considered final
agency action.
(C) The revision shall clarify that substances that
are known (or reasonably anticipated) to cause cancer
in humans or animals identified by the National
Toxicology Program cannot be GRAS.
(D) The revision shall clarify that substances that
show clear evidence (or some evidence) of human
reproductive or developmental toxicity identified by
the National Toxicology Program cannot be GRAS.
(E) The revision shall clarify that any substance
that was not marketed for use in foods in the United
States before issuance of the revised rule cannot be
GRAS and shall be approved by the Secretary through a
food additive petition as required by section 409(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
348(c)) prior to being marketed in food.
(F) The revision shall--
(i) incorporate standards prohibiting
conflict of interests among experts providing
data for substances submitted for GRAS review;
and
(ii) incorporate measures to strengthen the
recommendations in the December 2022 guidance
of the Food and Drug Administration titled
``Best Practices for Convening a GRAS Panel''.
(G) The revision shall create a process that
requires the Secretary to systematically reassess any
substance that was determined to be GRAS if the initial
determination did not meet the revised standards for
such a determination, in accordance with the procedures
and resources in section 409A of the Federal Food,
Drug, and Cosmetic Act, as added by section 3.
SEC. 3. OFFICE OF FOOD CHEMICAL SAFETY, DIETARY SUPPLEMENTS, AND
INNOVATION.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended by inserting after section 409 (21 U.S.C. 348)
the following:
``SEC. 409A. OFFICE OF FOOD CHEMICAL SAFETY, DIETARY SUPPLEMENTS, AND
INNOVATION.
``(a) Definitions.--In this section:
``(1) Food contact substance.--The term `food contact
substance' has the meaning given such term in section
409(h)(6).
``(2) Generally recognized as safe for use in food.--The
term `generally recognized as safe for use in food' means, with
respect to the use of a substance in food, that the 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,
as described in section 201(s).
``(3) Prior-sanctioned substance.--The term `prior-
sanctioned substance' means a substance described in paragraph
(4) of section 201(s).
``(4) Reproductive or developmental toxicity.--The term
`reproductive or developmental toxicity' means--
``(A) adverse effects on the reproductive systems
of female or male humans or animals, that may include
alterations to the female or male 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; or
``(B) adverse effects on developing organisms that
result from exposure prior to conception, during the
prenatal period, or until the time of sexual maturity.
``(5) Vulnerable human population.--The term `vulnerable
human population' means a human population that is subject to
the potential for disproportionate exposure to, or the
potential for disproportionate adverse effects from exposure
to, a chemical substance or mixture, including--
``(A) infants, children, and adolescents;
``(B) pregnant, postpartum, or breastfeeding women;
``(C) older adults;
``(D) individuals with preexisting medical
conditions;
``(E) workers who may be exposed to chemical
substances and mixtures;
``(F) residents in communities subject to
disproportionate exposures or adverse effects; and
``(G) members of any other appropriate population
identified by the Secretary.
``(b) Establishment.--Not later than 1 year after the date of
enactment of this section, the Secretary shall establish within the
Food and Drug Administration an office, to be known as the `Office of
Food Chemical Safety, Dietary Supplements, and Innovation' (referred to
in this section as the `Office'), to evaluate and reassess the safety,
within the meaning of section 409, of substances and classes of
substances, including food additives, food contact substances,
substances generally recognized as safe for use in food, color
additives, and prior-sanctioned substances.
``(c) Safety Reassessments.--Not later than 3 years after the date
on which the Office is established, and not less frequently than once
every 3 years thereafter, the Office shall--
``(1) reassess the safety of not less than 10 of the
substances or classes of substances described in subsection
(b); and
``(2) issue final regulations--
``(A) determining that any such substance or class
of substance is safe within the meaning of section 409
and establishing the conditions of use, if any, under
which any such substance or class of substances can be
used safely within the meaning of such section; or
``(B) determining that any such substance or class
of substances is unsafe within the meaning of such
section.
``(d) Considerations.--In determining, for the purposes of this
section, whether a substance or class of substances is unsafe within
the meaning of section 409, the Secretary shall consider among other
relevant factors--
``(1) the cumulative effects of the substance, as described
under such section 409; and
``(2) an adequately protective use of safety factors, as
described under such section 409, including safety factors to
account for the particular sensitivities of vulnerable human
populations.
``(e) Notice Prior to Selecting Substances for Reassessment.--Prior
to selecting substances or classes of substances to reassess under
subsection (c), the Secretary shall post a notice in the Federal
Register requesting information and recommendations on which substances
and classes should be reassessed. The information shall include
substance or class name, uses, and data relating to the actual and
potential hazards and impact on public health.
``(f) Notice Prior to Commencement.--Prior to commencing a
reassessment of a substance or class of substances under subsection
(c), the Secretary shall post a notice in the Federal Register
requesting information on any uses of such substance or class in food,
including as a prior-sanctioned substance, food contact substance, or
substance that is generally recognized as safe for use in food. The
information requested shall include when the uses commenced, the
specific conditions of use, how they were determined to be safe,
scientific evidence relevant to the safety of the substance that has
become available since its use in food commenced, and the anticipated
amounts that may be found in food.
``(g) Food Chemical Committee of the Science Board.--Not later than
180 days after the date of enactment of this section, the Secretary
shall establish a standing Food Chemical Committee (referred to in this
subsection as the `Committee') within the Science Board to the Food and
Drug Administration and provide resources and staffing as are necessary
for the Committee to meet regularly and complete their work. The
Committee shall advise the Secretary with respect to the process and
methods necessary to complete the work of the Office.
``(h) 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.''.
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