Title: Humane Cosmetics Act of 2021
Policy area: Health

Summary:
Humane Cosmetics Act of 2021
This bill generally prohibits animal testing in the evaluation of cosmetic products, and it prohibits the sale or transport of cosmetics developed using animal testing, subject to civil penalties. These prohibitions begin one year after enactment.
The bill specifies exceptions to these prohibitions, including if such animal testing (1) is conducted outside the United States to comply with a foreign regulatory authority; (2) is pursuant to a specified finding that there are no nonanimal alternatives to test the safety of a potentially dangerous cosmetic product or ingredient; (3) is of a product or ingredient for a drug or device subject to regulation by the Food and Drug Administration (FDA); or (4) is required for a noncosmetic purpose pursuant to a state, federal, or foreign regulatory authority.
Further, no animal-testing evidence may be used to establish the safety of a cosmetic product or ingredient that is regulated by the FDA after the effective date of this bill, subject to limited exceptions.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3357 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 3357

   To substantially restrict the use of animal testing for cosmetics.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 9, 2021

 Mr. Booker (for himself, Mr. Portman, Mr. Hickenlooper, Ms. Collins, 
and Ms. Rosen) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 2021''.

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 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.--Beginning on the date that 
is 1 year after the date of enactment of this Act, it shall be unlawful 
to sell, offer for sale, or knowingly 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 cosmetic product's supply chain 
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) in the case of such testing on an ingredient or 
                nonfunctional constituent, 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; 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, 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 the cosmetic ingredient or nonfunctional 
                        constituent;
                            (ii) there is a reasonable probability that 
                        the ingredient or nonfunctional constituent 
                        poses a specific and serious adverse human 
                        health risk and the need to conduct an animal 
                        test is justified and supported by a detailed 
                        research protocol that is proposed for the 
                        basis for evaluation of the cosmetic ingredient 
                        or nonfunctional constituent; and
                            (iii) the cosmetic ingredient or 
                        nonfunctional 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, 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) 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 under 
        applicable law, any person who violates this section may be 
        subject to 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.
    (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 (j) and that 
does not include the exemptions contained in subsections (c), (d), and 
(j). 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 of, 
        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 
                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, and which shall be for 
                informational purposes and shall not be deemed to 
                constitute a list of the only acceptable non-animal 
                test methods) of--
                            (i) 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;
                            (ii) next generation risk assessment 
                        methods; and
                            (iii) examples of alternative methods and 
                        strategies that have been accepted by the 
                        Secretary; and
                    (D) to the maximum extent practicable given 
                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.--Not 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.--Not later than 1 
                year after the date of the public meeting under 
                subparagraph (A), and annually thereafter, the 
                Secretary shall convene a separate public meeting or 
                add as an agenda item to an already existing meeting, 
                in-person or virtually, 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) 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 
                nonfunctional 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.
    (k) 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 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 under 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.).
    (l) 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 
        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) 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) 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.
            (5) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
                                 <all>