ing, 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 Fed-
eral agency, the Interagency Coordinating 
Committee on the Validation of Alternative 
Methods, or the Organisation for Economic 
Co-operation and Development for the rel-
evant safety endpoints for the cosmetic in-
gredient or nonfunctional constituent; 
(ii) there is a reasonable probability 
that the ingredient or nonfunctional con-
stituent poses a specific and serious ad-
verse human health risk and the need to 
conduct an animal test is justified and 
supported by a detailed research protocol 
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that is proposed for the basis for evalua-
tion of the cosmetic ingredient or nonfunc-
tional constituent; 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, on the 
website of the Food and Drug Administration, 
of the written finding under subparagraph (A) 
together with a notice that the Secretary in-
tends to request, require, or conduct new ani-
mal testing, and providing a period of not less 
than 60 calendar days for public comment; and 
(C) a written determination by the Sec-
retary, after review of all public comments re-
ceived pursuant to subparagraph (B), that no 
previously generated data that could be sub-
stituted for, or otherwise determined sufficient 
to replace, the data expected to be produced 
through new animal testing is available for re-
view by the Secretary; 
(3) conducted for any product or ingredient 
that is subject to regulation under chapter V of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.); or 
(4) conducted for non-cosmetic purposes pursu-
ant 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 vio-
lates 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, con-
stitutes 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 
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meet the criteria in subsection (c)(1)(B)(ii). Such 
manufacturer shall, upon such request of the Sec-
retary in writing, provide to the Secretary such 
records or other information, within a reasonable 
timeframe, within reasonable limits, and in a reason-
able manner, and in either electronic or physical 
form, at the expense of such manufacturer. The Sec-
retary’s request shall include a sufficient description 
of the records requested and reference this sub-
section. 
(2) CONFIRMATION OF RECEIPT.—Upon receipt 
of the records requested under paragraph (1), the 
Secretary shall provide to the manufacturer con-
firmation 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 sub-
division 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 
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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 ani-
mals, 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 Administra-
tion a strategic plan to promote the develop-
ment and implementation of alternative test 
methods and strategies to replace vertebrate 
animal testing for assessing the safety of cos-
metics; 
(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 Sec-
retary shall update on a regular basis, and 
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