[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5399 Introduced in House (IH)]

<DOC>






118th CONGRESS
  1st Session
                                H. R. 5399

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 12, 2023

 Mr. Beyer (for himself, Mr. Buchanan, Mr. Cardenas, Mr. Calvert, and 
  Mr. Tonko) 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 2023''.

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.
                                 <all>