[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9817 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 9817
To direct the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, to update and clarify its rule on
substances generally recognized as safe, and for other purposes.
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IN THE HOUSE OF REPRESENTATIVES
September 25, 2024
Ms. DeLauro introduced the following bill; which was referred to the
Committee on Energy and Commerce
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A BILL
To direct the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, to update and clarify its rule on
substances generally recognized as safe, 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 ``Toxic Free Food Act of 2024''.
SEC. 2. DIRECTED RULEMAKING REGARDING SUBSTANCES GENERALLY RECOGNIZED
AS SAFE.
(a) Directed Rulemaking.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall--
(A) not later than 180 days 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 Federal Register
54960 et seq.); and
(B) not later than 90 days after the close of the
period for public comment on the revision proposed
pursuant to subparagraph (A), publish a final revision
to such final rule.
(2) Contents.--The revision required by 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 received notice that
the manufacturer has determined such substance
to be GRAS; and
(ii) the manufacturer has provided the
Secretary with supporting information
sufficient to understand the basis of the
determination, including, as required by the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.)--
(I) the cumulative effects of the
substance, as required under section
409 of such Act (21 U.S.C. 348);
(II) an adequately protective use
of safety factors; and
(III) application of a margin of
safety to take into account the impacts
of exposures during critical windows of
development and on vulnerable
populations.
(B) The revision shall require the Secretary--
(i) 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; and
(ii) provide 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 section 409(c)(5) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 348(c)(5)).
(C) The revision shall clarify that newly
synthesized or novel chemical substances cannot be
GRAS.
(D) The revision shall clarify that carcinogenic
substances cannot be GRAS.
(E) The revision shall--
(i) prohibit the Secretary from relying on
the determination of experts with conflicts of
interest when determining a substance to be
GRAS; and
(ii) incorporate the recommendations in the
draft guidance titled ``Best Practices for
Convening a GRAS Panel'', issued by the Food
and Drug Administration in November, 2017, and
measures to strengthen the recommendations in
such guidance.
(F) The revision shall create a process that
requires the Secretary to systematically reassess any
substance that was determined to be GRAS if such
determination did not meet the revised standards for
such a determination.
(b) Food Advisory Committee.--Not later than 180 days after the
date of enactment of this Act, the Secretary shall--
(1) reestablish the Food Advisory Committee to work with
the Secretary on the reassessment standards, process, and
methods necessary to complete the work described in subsection
(a)(2)(F); and
(2) provide such Committee with such staffing and resources
as are necessary to complete such work.
(c) Definitions.--In this subsection:
(1) The term ``GRAS'' means, with respect to a substance,
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) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).
(2) The term ``Secretary'' means the Secretary of Health
and Human Services.
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