I 
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 con-
duct 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 Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
require the Office of Food Chemical Safety, Dietary Sup-
plements, and Innovation to conduct food chemical safety 
reassessments, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food Chemical Reas-
sessment Act of 2025’’. 
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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 ‘Of-
fice’), 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 class-
es thereof (as described in section 201(s)(4)). 
‘‘(E) Food contact substances, as defined 
in subsection (h)(6). 
‘‘(2) PUBLIC NOTICE.—The Secretary shall pro-
vide public notice of the determinations made from 
each reassessment conducted under paragraph (1). 
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‘‘(3) EFFECT
OF
REASSESSMENT.—The Sec-
retary 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 deter-
mination that— 
‘‘(i) any such substance is safe for 
purposes of this subsection and estab-
lishing the conditions of use, if any, under 
which any such substance or class of sub-
stances can be used safely; or 
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‘‘(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 dem-
onstrates the prior-sanctioned use of such sub-
stance 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 no-
tification under subsection (h) for the food con-
tact substance involved is no longer effective if 
such reassessment demonstrates that the use of 
such substance is not safe. 
‘‘(4) DETERMINATION
OF
SUBSTANCES
SUB-
JECT 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 RE-
ASSESSMENT.—The Secretary may select, as 
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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 en-
forcement 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 Sec-
retary shall re-establish the Food Advisory Com-
mittee to advise the Secretary with respect to— 
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‘‘(A) the standards for reassessments con-
ducted 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.’’. 
Æ 
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