119-hr4306

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4306 Introduced in House

    (IH) ]

<DOC>

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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