[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4306 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 4306
To amend the Federal Food, Drug, and Cosmetic Act to require the Office
of Food Chemical Safety, Dietary Supplements, and Innovation to conduct
food chemical safety reassessments, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 10, 2025
Ms. Schakowsky (for herself, Ms. DeLauro, Ms. Adams, Mr. Carson, Ms.
Jayapal, Mr. Khanna, Mr. Krishnamoorthi, Ms. Meng, Mr. Moulton, Mr.
Mullin, Ms. Norton, Ms. Pingree, Ms. Titus, and Ms. Tlaib) 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 the Office
of Food Chemical Safety, Dietary Supplements, and Innovation to conduct
food chemical safety 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 ``Food Chemical Reassessment Act of
2025''.
SEC. 2. FOOD SAFETY REASSESSMENTS.
Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
348) is amended by adding at the end the following:
``(l) Food Safety Reassessments.--
``(1) In general.--Not less frequently than once every 3
years beginning with 2026, the Office of Food Chemical Safety,
Dietary Supplements, and Innovation (referred to in this
section as the `Office'), shall systematically and continuously
reassess the safety of not less than a combination of 10 of the
following substances (or classes thereof):
``(A) Food additives marketed pursuant to an order
under subsection (c).
``(B) Color additives, as defined in section
201(t).
``(C) Substances generally recognized as safe for
use in food (as defined in section 201(s)).
``(D) Prior-sanctioned substances, or classes
thereof (as described in section 201(s)(4)).
``(E) Food contact substances, as defined in
subsection (h)(6).
``(2) Public notice.--The Secretary shall provide public
notice of the determinations made from each reassessment
conducted under paragraph (1).
``(3) Effect of reassessment.--The Secretary shall--
``(A) in the case of a reassessment of a substance
described in subparagraph (A) of paragraph (1), amend
or repeal a regulation under subsection (c) issued with
respect to such substance if such reassessment
demonstrates that the substance is not safe;
``(B) in the case of a reassessment of a substance
described in subparagraph (B) of paragraph (1), amend
or repeal a regulation under section 721 issued with
respect to such substance if such reassessment
demonstrates that the substance is not safe;
``(C) in the case of a reassessment of a substance
described in subparagraph (C) of paragraph (1), make
public on the website of the Food and Drug
Administration the determination that--
``(i) any such substance is safe for
purposes of this subsection and establishing
the conditions of use, if any, under which any
such substance or class of substances can be
used safely; or
``(ii) any such substance or class of
substances is unsafe for purposes of this
section;
``(D) in the case of a reassessment of a substance
described in subparagraph (D) of paragraph (1), revoke
the prior-sanctioned use of the substance if such
reassessment demonstrates the prior-sanctioned use of
such substance may be injurious to health; and
``(E) in the case of a reassessment of a substance
described in subparagraph (E) of paragraph (1),
determine that a pre-market notification under
subsection (h) for the food contact substance involved
is no longer effective if such reassessment
demonstrates that the use of such substance is not
safe.
``(4) Determination of substances subject to
reassessment.--
``(A) In general.--In determining which substances
or classes of substances to reassess under paragraph
(1), the Secretary shall prioritize substances or
classes thereof by public health need.
``(B) First substances subject to reassessment.--
The Secretary may select, as the first 10 substances
(or classes thereof) to be reassessed under this
subsection, the following:
``(i) Tert-butylhydroquinone.
``(ii) Titanium dioxide.
``(iii) Red dye 40, yellow dye 5, yellow
dye 6, blue dye 01, blue dye 02, and green dye
03.
``(iv) Perchlorate.
``(v) Butylated hydroxyanisole (BHA).
``(vi) Butylated hydroxytoluene (BHT).
``(vii) Trichloroethylene, methylene
chloride, benzene, and ethylene chloride.
``(viii) Propyl gallate.
``(ix) Sodium benzoate.
``(x) Sodium nitrite.
``(5) Rule of construction.--Nothing in this subsection
alters the authority or duties of the Secretary with respect to
the administration and enforcement of the preceding provisions
of this section.
``(6) Food advisory committee.--Not later than 180 days
after the date of enactment of the Food Chemical Reassessment
Act of 2025, the Secretary shall re-establish the Food Advisory
Committee to advise the Secretary with respect to--
``(A) the standards for reassessments conducted
under this section; and
``(B) the process and methods necessary to complete
the work of the Office.
``(7) Class defined.--In this subsection, the term `class',
with respect to substances referred to in paragraph (1), means
a group of chemicals that are chemically similar or cause
similar or related pharmacological effects.''.
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