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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5141 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 5141

   To substantially restrict the use of animal testing for cosmetics.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           November 18, 2019

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

    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 2019''.

SEC. 2. ANIMAL TESTING.

    (a) Prohibition on Animal Testing.--Beginning 1 year after the date 
of enactment of this Act, it shall be unlawful for any person, whether 
private or governmental, to knowingly conduct or contract for cosmetic 
animal testing that occurs in the United States.
    (b) Prohibition on Sale or Transport.--It shall be unlawful to 
sell, offer for sale, or knowingly transport in interstate commerce in 
the United States any cosmetic that was developed or manufactured using 
cosmetic animal testing that was conducted or contracted for by any 
person in the cosmetic product's supply chain after the date that is 1 
year after the date of enactment of this Act.
    (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 non-functional constituent under the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
        unless--
                    (A) in the case of such testing on an ingredient or 
                non-functional constituent, there is no non-animal 
                alternative method or strategy recognized by any 
                Federal agency or the Organisation for Economic Co-
                operation and Development for the relevant safety 
                endpoints for such ingredient or non-functional 
                constituent; and
                    (B)(i) such animal testing is subject to an 
                exemption under paragraph (2) or (3) of subsection (d); 
                or
                    (ii)(I) such animal testing is subject to an 
                exemption under paragraph (4) of subsection (d);
                    (II) there is documented evidence of the non-
                cosmetic intent of the test; and
                    (III) there is a history of use of the ingredient 
                outside of cosmetics at least 1 year prior to the 
                reliance on such data.
            (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 recognized by any Federal 
                        agency or the Organisation for Economic Co-
                        operation and Development for the relevant 
                        safety endpoints for the cosmetic ingredient or 
                        non-functional constituent;
                            (ii) the cosmetic ingredient or non-
                        functional constituent poses a risk of causing 
                        serious adverse health consequences or death; 
                        and
                            (iii) the cosmetic ingredient or non-
                        functional constituent is in wide use and, in 
                        the case of a cosmetic ingredient, cannot be 
                        replaced by another cosmetic ingredient capable 
                        of performing a similar function;
                    (B) publication by the Secretary of the written 
                finding required by subparagraph (A) on the internet 
                website of the Food and Drug Administration together 
                with a notice that the Secretary intends to request, 
                require, or conduct new animal testing, and provides 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) Rule of Construction.--With the exception of records or other 
information demonstrating compliance with subsection (c)(1)(B)(ii), 
nothing in this section shall be construed to authorize the Secretary 
to impose any new recordkeeping requirements relating to cosmetic 
animal testing.
    (f) Civil Penalties.--
            (1) In general.--In addition to any other penalties 
        applicable under law, the Secretary shall assess whoever 
        violates any provision of this section a civil penalty of not 
        more than $10,000 for each such violation.
            (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.
    (g) 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). 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.).
    (h) 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, labeling, 
and packaging related to animal testing, that is not identical to the 
prohibitions set forth in subsections (a), (b), (c), and (k) and that 
does not include the exemptions contained in subsections (c), (d), and 
(k). No State or political subdivision of a State may require any 
entity to perform cosmetic animal testing that is not permitted by 
subsection (a).
    (i) FDA Strategic Plan for Non-Animal Test Methods.--
            (1) Scientific innovation.--To promote the development and 
        provide for expedited review and acceptance of new 
        scientifically valid test methods and strategies that are not 
        based on vertebrate animals, the Secretary shall--
                    (A) not later than 1 year after the date of 
                enactment of this Act, develop and publish on the 
                internet website of the Food and Drug Administration a 
                strategic plan to promote the development and 
                implementation of alternative test methods and 
                strategies to replace vertebrate animal testing for 
                assessing the safety of cosmetics;
                    (B) provide a period of not less than 60 calendar 
                days for public comment regarding such strategic plan;
                    (C) include in the strategic plan developed under 
                subparagraph (A) a list, which the Secretary shall 
                update on a regular basis, of scientifically reliable 
                and relevant non-animal test methodology as 
                alternatives to animal testing that have been 
                recognized by any Federal agency or an international 
                regulatory agency, which also includes next generation 
                risk assessment methods, and a list of examples of 
                alternative methods and strategies that have been 
                accepted by the Secretary (such lists shall be for 
                information purposes and shall not be deemed to 
                constitute a list of the only acceptable non-animal 
                test methods); and
                    (D) to the maximum extent practicable with 
                available resources, prioritize and carry out 
                performance assessment, validation, and translational 
                studies to accelerate the development of scientifically 
                valid test methods and strategies that replace the use 
                of vertebrate animals.
            (2) Public meetings.--
                    (A) Initial meeting.--No later than 90 days after 
                the date of enactment of this Act, the Secretary shall 
                convene a public meeting regarding the strategic plan 
                described in paragraph (1)(A).
                    (B) Subsequent annual meetings.--No later than 1 
                year after the date of the public meeting under 
                subparagraph (A), and annually thereafter, the 
                Secretary shall convene a public meeting to inform the 
                Secretary's advancement of alternative test methods and 
                strategies to replace vertebrate animal testing for 
                assessing the safety of cosmetics. The Secretary shall 
                include in such meetings scientific and academic 
                experts, animal and consumer advocacy groups, and the 
                regulated industry.
            (3) Rule of construction.--Nothing in this subsection shall 
        be construed to limit the authority of the Secretary to address 
        other tools to promote the development and implementation of 
        alternative test methods and strategies to replace vertebrate 
        animal testing for assessing the safety of cosmetics as part of 
        the strategic plan described in paragraph (1)(A).
    (j) 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, or any cosmetic ingredient or 
        non-functional 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 non-functional constituent 
        for use in a cosmetic product.
            (3) Label.--The term ``label'' has the meaning given such 
        term in section 201(k) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 321(k)).
            (4) Non-functional constituent.--The term ``non-functional 
        constituent'' means any incidental ingredient as defined in 
        section 701.3(1) of title 21, Code of Federal Regulations, on 
        the date of enactment of this section.
            (5) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (k) Consumer Information Related to Animal Testing.--
            (1) In general.--A cosmetic product manufacturer shall not 
        include on the label of a cosmetic product or any of the 
        product's containers or wrappers a claim that such cosmetic 
        product was not tested on animals, including any claim or logo 
        of ``cruelty free'' if--
                    (A) such cosmetic product or any ingredient or non-
                functional constituent contained in such cosmetic 
                product was tested on an animal after the effective 
                date specified in subsection (a); and
                    (B)(i) the testing was conducted by or contracted 
                for by the cosmetic product manufacturer or another 
                person in the supply chain at the direction or request 
                of the cosmetic product manufacturer; or
                    (ii) the cosmetic product manufacturer relied upon 
                evidence from such testing, pursuant to subsection 
                (c)(1)(B)(ii), to establish the safety of such product, 
                ingredient, or nonfunctional constituent under chapter 
                VI of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 361 et seq.).
            (2) Exceptions.--Notwithstanding paragraph (1), a cosmetic 
        product manufacturer may include a claim described in such 
        paragraph on the label of a cosmetic product described in such 
        paragraph or any of the product's containers or wrappers if--
                    (A) such testing qualifies for the exemption under 
                subsection (d)(4); and
                    (B)(i) in the case of animal testing conducted by 
                or contracted for by the cosmetic product manufacturer 
                or another person in the supply chain at the direction 
                or request of the cosmetic product manufacturer, the 
                cosmetic manufacturer did not rely upon evidence from 
                such testing for the purpose of establishing the safety 
                of the product, ingredient, or nonfunctional 
                constituent under chapter VI of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 361 et seq.); or
                    (ii) in the case of animal testing conducted by or 
                contracted for by a person that is not described in 
                clause (i), evidence from which the cosmetic product 
                manufacturer relied upon, pursuant to subsection 
                (c)(1)(B)(ii), to establish the safety of such product, 
                ingredient, or nonfunctional constituent under chapter 
                VI of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 361 et seq.), the cosmetic product manufacturer 
                includes on the label a disclosure describing the 
                circumstances surrounding the use of the exemption 
                under subsection (c)(1)(B)(ii) by such manufacturer 
                that includes a reference to the specific Federal, 
                State, or foreign requirement under which the animal 
                testing was conducted or a reference to a publicly 
                available internet website of such manufacturer that 
                provides such disclosure.
    (l) Report.--Beginning 2 years after the date of enactment of this 
Act, the Secretary shall biennially submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, and make available 
on the internet website of the Food and Drug Administration, a report 
that includes, with respect to the previous 2 fiscal years--
            (1) updates on the Secretary's implementation of this 
        section, including developments implementing the strategic plan 
        under subsection (i)(1)(A);
            (2) the number of times the Secretary requested animal test 
        data as set forth in subsection (d)(2), the ingredients 
        involved, and the animal tests performed; and
            (3) based on the data reviewed by the Secretary under 
        subsection (g)(1), the number of times manufacturers relied 
        upon data pursuant to the exemption under subsection (d)(4) to 
        establish the safety of a cosmetic under chapter VI of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.).
                                 <all>
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