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>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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