119-hr1657

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1657 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 1657

To substantially restrict the use of animal testing for cosmetics, and 
 for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 February 27, 2025

 Mr. Beyer (for himself, Mr. Buchanan, Mr. Tonko, Mr. Calvert, Ms. 
 Barragan, Ms. Tlaib, Ms. Titus, Mr. Lynch, Ms. Malliotakis, Ms. 
 Scanlon, Ms. Jayapal, Mr. Subramanyam, Ms. DelBene, Mr. Stanton, Ms. 
 Scholten, Ms. Kelly of Illinois, Ms. Stansbury, Mr. Quigley, Mr. 
Doggett, Mr. Casten, Ms. Pingree, Mr. Meeks, Ms. Norton, Mr. Kennedy of 
New York, Mr. Schneider, Mr. Mullin, Ms. Sanchez, Mr. Mrvan, Mr. Carter 
 of Louisiana, Mr. Garcia of California, Mr. Correa, Mrs. Cherfilus-
McCormick, Ms. Chu, Ms. Sherrill, Mr. Krishnamoorthi, Mr. Connolly, Mr. 
David Scott of Georgia, Ms. Bonamici, Mr. Amo, Mrs. McBath, Ms. Bynum, 
Ms. Salinas, Ms. Ross, Ms. Williams of Georgia, Ms. Meng, Ms. McCollum, 
 and Ms. Schrier) introduced the following bill; which was referred to 
 the Committee on Energy and Commerce

_______________________________________________________________________

 A BILL

To substantially restrict the use of animal testing for cosmetics, 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 ``Humane Cosmetics Act of 2025''.

SEC. 2. ANIMAL TESTING.

    (a) Prohibition on Animal Testing.--Beginning on the date that is 1 
year after the date of enactment of this Act, it shall be unlawful to 
knowingly conduct or contract for cosmetic animal testing that occurs 
in the United States.

    (b) Prohibition on Sale or Transport.--Beginning on the date that 
is 1 year after the date of enactment of this Act, it shall be unlawful 
to knowingly sell, offer for sale, or transport in interstate commerce 
in the United States any cosmetic product that was developed or 
manufactured using cosmetic animal testing that was conducted or 
contracted for by any person in the supply chain of the cosmetic 
product after such date.
            (c) Data Use.--

    (1) In general.--No evidence derived from animal testing 
 conducted after the effective date specified in subsection

    (a) may be relied upon to establish the safety of a cosmetic, 
 cosmetic ingredient, or nonfunctional constituent under the 
 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
 unless--
        (A) such animal testing is subject to an exemption 
 under subsection
            (d) (2) ; or
        (B) in the case of such animal testing on an 
 ingredient or nonfunctional constituent--
            (i) there is no non-animal alternative 
 method or strategy recognized by any Federal 
 agency, the Interagency Coordinating Committee 
 on the Validation of Alternative Methods, or 
 the Organisation for Economic Co-operation and 
 Development for the relevant safety endpoints 
 for such ingredient or nonfunctional 
 constituent for use in cosmetics; and
            (ii) 
            (I) such animal testing is subject to 
 an exemption under subsection
            (d) (3) ; or
            (II) (aa) such animal testing is subject to 
 an exemption under subsection
            (d) (4) ;

    (bb) there is documented evidence of the 
 non-cosmetic intent of the test; and
            (cc) there is a history of use of the 
 ingredient outside of cosmetics at least 1 year 
 prior to the reliance on evidence described in 
 the matter preceding subparagraph
        (A) .

    (2) Limitation.--This section shall not be construed to 
 prohibit any entity from reviewing, assessing, or retaining 
 evidence generated from animal testing.
            (d) Exemptions.--Subsections

    (a) and

    (b) shall not apply with 
respect to animal testing--

    (1) conducted outside the United States in order to comply 
 with a requirement from a foreign regulatory authority;

    (2) requested, required, or conducted by the Secretary, 
 following--
        (A) a written finding by the Secretary that--
            (i) there is no non-animal alternative 
 method or strategy for the relevant safety 
 endpoints for the cosmetic ingredient or 
 nonfunctional constituent;
            (ii) there is information received by the 
 Secretary of adverse health effects, other than 
 minor and transient reactions or minor and 
 transient skin irritations in some users, 
 related to the cosmetic ingredient or 
 nonfunctional constituent; and
            (iii) the cosmetic ingredient cannot be 
 replaced by another cosmetic ingredient capable 
 of performing a similar function;
        (B) publication by the Secretary, on the website of 
 the Food and Drug Administration, of the written 
 finding under subparagraph
        (A) together with a notice 
 that the Secretary intends to request, require, or 
 conduct new animal testing, and providing a period of 
 not less than 60 calendar days for public comment; and
            (C) a written determination by the Secretary, after 
 review of all public comments received pursuant to 
 subparagraph
        (B) , that no previously generated data 
 that could be substituted for, or otherwise determined 
 sufficient to replace, the data expected to be produced 
 through new animal testing is available for review by 
 the Secretary;

    (3) conducted for any product or ingredient that is subject 
 to regulation under chapter V of the Federal Food, Drug, and 
 Cosmetic Act (21 U.S.C. 351 et seq.); or

    (4) conducted for non-cosmetic purposes pursuant to a 
 requirement of a Federal, State, or foreign regulatory 
 authority.

    (e) Civil Penalties.--

    (1) In general.--In addition to any other penalties under 
 applicable law, the Secretary may impose on any person who 
 violates this section a civil penalty in an amount of not more 
 than $10,000 for each such violation, as determined by the 
 Secretary.

    (2) Multiple violations.--Each violation of this section 
 with respect to a separate animal, and each day that a 
 violation of this Act continues, constitutes a separate 
 offense.

    (f) Records Access.--

    (1) In general.--The Secretary may request any records or 
 other information from a cosmetic manufacturer that such 
 manufacturer relied upon to meet the criteria in subsection
            (c) (1)
        (B)
            (ii) 
            (II) . Such manufacturer shall, upon such request 
 of the Secretary in writing, provide to the Secretary such 
 records or other information, within a reasonable timeframe, 
 within reasonable limits, and in a reasonable manner, and in 
 either electronic or physical form, at the expense of such 
 manufacturer. The Secretary's request shall include a 
 sufficient description of the records requested and reference 
 this subsection.

    (2) Confirmation of receipt.--Upon receipt of the records 
 requested under paragraph

    (1) , the Secretary shall provide to 
 the manufacturer confirmation of receipt.

    (3) Inspection authority.--Nothing in this subsection 
 supplants the authority of the Secretary to conduct inspections 
 otherwise permitted under the Federal Food, Drug, and Cosmetic 
 Act (21 U.S.C. 301 et seq.).

    (g) State Authority.--No State or political subdivision of a State 
may establish or continue in effect any prohibition relating to 
cosmetic animal testing, or to the regulation of data use related to 
animal testing, that is not identical to the prohibitions set forth in 
subsections

    (a) ,

    (b) , and
            (c) , and that does not include the exemptions 
contained in subsections
            (c) and
            (d) . No State or political subdivision 
of a State may require any entity to perform cosmetic animal testing 
that is not permitted by subsection

    (a) .

    (h) 

=== Definitions. ===
-

    (1) Cosmetic.--The term ``cosmetic'' has the meaning given 
 such term in 

section 201
            (i) of the Federal Food, Drug, and 
 Cosmetic Act (21 U.S.C. 321
            (i) ).

    (2) Cosmetic animal testing.--The term ``cosmetic animal 
 testing'' means the internal or external application or 
 exposure of any cosmetic product, cosmetic ingredient, or 
 nonfunctional constituent to the skin, eyes, or other body part 
 (organ or extremity) of a live non-human vertebrate for the 
 purpose of evaluating the safety or efficacy of a cosmetic 
 product or a cosmetic ingredient or nonfunctional constituent 
 for use in a cosmetic product.

    (3) Nonfunctional constituent.--The term ``nonfunctional 
 constituent'' means any incidental ingredient as defined in 
 

section 701.3
            (l) of title 21, Code of Federal Regulations, on 
 the date of enactment of this section.

    (4) Secretary.--The term ``Secretary'' means the Secretary 
 of Health and Human Services.
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