Humane Cosmetics Act of 2019
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. These prohibitions begin one year after enactment.
[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.).
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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