I 

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. CA ́RDENAS, 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Humane Cosmetics 

5 Act of 2019’’. 

6 SEC. 2. ANIMAL TESTING. 

7 (a) PROHIBITION ON ANIMAL TESTING.—Beginning 

8 1 year after the date of enactment of this Act, it shall 

9 be unlawful for any person, whether private or governVerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141

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1 mental, to knowingly conduct or contract for cosmetic ani2 mal testing that occurs in the United States. 

3 (b) PROHIBITION ON SALE OR TRANSPORT.—It shall 

4 be unlawful to sell, offer for sale, or knowingly transport 

5 in interstate commerce in the United States any cosmetic 

6 that was developed or manufactured using cosmetic ani7 mal testing that was conducted or contracted for by any 

8 person in the cosmetic product’s supply chain after the 

9 date that is 1 year after the date of enactment of this 

10 Act. 

11 (c) DATA USE.— 

12 (1) IN GENERAL.—No evidence derived from 

13 animal testing conducted after the effective date 

14 specified in subsection (a) may be relied upon to es15 tablish the safety of a cosmetic, cosmetic ingredient, 

16 or non-functional constituent under the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

18 seq.), unless— 

19 (A) in the case of such testing on an ingre20 dient or non-functional constituent, there is no 

21 non-animal alternative method or strategy rec22 ognized by any Federal agency or the 

23 Organisation for Economic Co-operation and 

24 Development for the relevant safety endpoints 


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1 for such ingredient or non-functional con2 stituent; and 

3 (B)(i) such animal testing is subject to an 

4 exemption under paragraph (2) or (3) of sub5 section (d); or 

6 (ii)(I) such animal testing is subject to an 

7 exemption under paragraph (4) of subsection 

8 (d); 

9 (II) there is documented evidence of the 

10 non-cosmetic intent of the test; and 

11 (III) there is a history of use of the ingre12 dient outside of cosmetics at least 1 year prior 

13 to the reliance on such data. 

14 (2) LIMITATION.—This section shall not be con15 strued to prohibit any entity from reviewing, assess16 ing, or retaining evidence generated from animal 

17 testing. 

18 (d) EXEMPTIONS.—Subsections (a) and (b) shall not 

19 apply with respect to animal testing— 

20 (1) conducted outside the United States in 

21 order to comply with a requirement from a foreign 

22 regulatory authority; 

23 (2) requested, required, or conducted by the 

24 Secretary, following— 


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1 (A) a written finding by the Secretary 

2 that— 

3 (i) there is no non-animal alternative 

4 method or strategy recognized by any Fed5 eral agency or the Organisation for Eco6 nomic Co-operation and Development for 

7 the relevant safety endpoints for the cos8 metic ingredient or non-functional con9 stituent; 

10 (ii) the cosmetic ingredient or non11 functional constituent poses a risk of caus12 ing serious adverse health consequences or 

13 death; and 

14 (iii) the cosmetic ingredient or non15 functional constituent is in wide use and, 

16 in the case of a cosmetic ingredient, cannot 

17 be replaced by another cosmetic ingredient 

18 capable of performing a similar function; 

19 (B) publication by the Secretary of the 

20 written finding required by subparagraph (A) 

21 on the internet website of the Food and Drug 

22 Administration together with a notice that the 

23 Secretary intends to request, require, or con24 duct new animal testing, and provides a period 


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1 of not less than 60 calendar days for public 

2 comment; and 

3 (C) a written determination by the Sec4 retary, after review of all public comments re5 ceived pursuant to subparagraph (B), that no 

6 previously generated data that could be sub7 stituted for, or otherwise determined sufficient 

8 to replace, the data expected to be produced 

9 through new animal testing is available for re10 view by the Secretary; 

11 (3) conducted for any product or ingredient 

12 that is subject to regulation under chapter V of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 351 et seq.); or 

15 (4) conducted for non-cosmetic purposes pursu16 ant to a requirement of a Federal, State, or foreign 

17 regulatory authority. 

18 (e) RULE OF CONSTRUCTION.—With the exception of 

19 records or other information demonstrating compliance 

20 with subsection (c)(1)(B)(ii), nothing in this section shall 

21 be construed to authorize the Secretary to impose any new 

22 recordkeeping requirements relating to cosmetic animal 

23 testing. 

24 (f) CIVIL PENALTIES.— 


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1 (1) IN GENERAL.—In addition to any other 

2 penalties applicable under law, the Secretary shall 

3 assess whoever violates any provision of this section 

4 a civil penalty of not more than $10,000 for each 

5 such violation. 

6 (2) MULTIPLE VIOLATIONS.—Each violation of 

7 this section with respect to a separate animal, and 

8 each day that a violation of this Act continues, con9 stitutes a separate offense. 

10 (g) RECORDS ACCESS.— 

11 (1) IN GENERAL.—The Secretary may request 

12 any records or other information from a cosmetic 

13 manufacturer that such manufacturer relied upon to 

14 meet the criteria in subsection (c)(1)(B)(ii). Such 

15 manufacturer shall, upon such request of the Sec16 retary in writing, provide to the Secretary such 

17 records or other information, within a reasonable 

18 timeframe, within reasonable limits, and in a reason19 able manner, and in either electronic or physical 

20 form, at the expense of such manufacturer. The Sec21 retary’s request shall include a sufficient description 

22 of the records requested and reference this sub23 section. 

24 (2) CONFIRMATION OF RECEIPT.—Upon receipt 

25 of the records requested under paragraph (1), the 


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1 Secretary shall provide to the manufacturer con2 firmation of receipt. 

3 (3) INSPECTION AUTHORITY.—Nothing in this 

4 subsection supplants the authority of the Secretary 

5 to conduct inspections otherwise permitted under the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 301 et seq.). 

8 (h) STATE AUTHORITY.—No State or political sub9 division of a State may establish or continue in effect any 

10 prohibition relating to cosmetic animal testing, or to the 

11 regulation of data use, labeling, and packaging related to 

12 animal testing, that is not identical to the prohibitions set 

13 forth in subsections (a), (b), (c), and (k) and that does 

14 not include the exemptions contained in subsections (c), 

15 (d), and (k). No State or political subdivision of a State 

16 may require any entity to perform cosmetic animal testing 

17 that is not permitted by subsection (a). 

18 (i) FDA STRATEGIC PLAN FOR NON-ANIMAL TEST

19 METHODS.— 

20 (1) SCIENTIFIC INNOVATION.—To promote the 

21 development and provide for expedited review and 

22 acceptance of new scientifically valid test methods 

23 and strategies that are not based on vertebrate ani24 mals, the Secretary shall— 


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1 (A) not later than 1 year after the date of 

2 enactment of this Act, develop and publish on 

3 the internet website of the Food and Drug Ad4 ministration a strategic plan to promote the de5 velopment and implementation of alternative 

6 test methods and strategies to replace verte7 brate animal testing for assessing the safety of 

8 cosmetics; 

9 (B) provide a period of not less than 60 

10 calendar days for public comment regarding 

11 such strategic plan; 

12 (C) include in the strategic plan developed 

13 under subparagraph (A) a list, which the Sec14 retary shall update on a regular basis, of sci15 entifically reliable and relevant non-animal test 

16 methodology as alternatives to animal testing 

17 that have been recognized by any Federal agen18 cy or an international regulatory agency, which 

19 also includes next generation risk assessment 

20 methods, and a list of examples of alternative 

21 methods and strategies that have been accepted 

22 by the Secretary (such lists shall be for infor23 mation purposes and shall not be deemed to 

24 constitute a list of the only acceptable non-ani25 mal test methods); and 


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1 (D) to the maximum extent practicable 

2 with available resources, prioritize and carry 

3 out performance assessment, validation, and 

4 translational studies to accelerate the develop5 ment of scientifically valid test methods and 

6 strategies that replace the use of vertebrate ani7 mals. 

8 (2) PUBLIC MEETINGS.— 

9 (A) INITIAL MEETING.—No later than 90 

10 days after the date of enactment of this Act, 

11 the Secretary shall convene a public meeting re12 garding the strategic plan described in para13 graph (1)(A). 

14 (B) SUBSEQUENT ANNUAL MEETINGS.— 

15 No later than 1 year after the date of the pub16 lic meeting under subparagraph (A), and annu17 ally thereafter, the Secretary shall convene a 

18 public meeting to inform the Secretary’s ad19 vancement of alternative test methods and 

20 strategies to replace vertebrate animal testing 

21 for assessing the safety of cosmetics. The Sec22 retary shall include in such meetings scientific 

23 and academic experts, animal and consumer ad24 vocacy groups, and the regulated industry. 


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1 (3) RULE OF CONSTRUCTION.—Nothing in this 

2 subsection shall be construed to limit the authority 

3 of the Secretary to address other tools to promote 

4 the development and implementation of alternative 

5 test methods and strategies to replace vertebrate 

6 animal testing for assessing the safety of cosmetics 

7 as part of the strategic plan described in paragraph 

8 (1)(A). 

9 (j) DEFINITIONS.— 

10 (1) COSMETIC.—The term ‘‘cosmetic’’ has the 

11 meaning given such term in section 201(i) of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 321(i)). 

14 (2) COSMETIC ANIMAL TESTING.—The term 

15 ‘‘cosmetic animal testing’’ means the internal or ex16 ternal application or exposure of any cosmetic prod17 uct, or any cosmetic ingredient or non-functional 

18 constituent, to the skin, eyes, or other body part 

19 (organ or extremity) of a live non-human vertebrate 

20 for the purpose of evaluating the safety or efficacy 

21 of a cosmetic product or a cosmetic ingredient or 

22 non-functional constituent for use in a cosmetic 

23 product. 


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1 (3) LABEL.—The term ‘‘label’’ has the meaning 

2 given such term in section 201(k) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 321(k)). 

4 (4) NON-FUNCTIONAL CONSTITUENT.—The 

5 term ‘‘non-functional constituent’’ means any inci6 dental ingredient as defined in section 701.3(1) of 

7 title 21, Code of Federal Regulations, on the date of 

8 enactment of this section. 

9 (5) SECRETARY.—The term ‘‘Secretary’’ means 

10 the Secretary of Health and Human Services. 

11 (k) CONSUMER INFORMATION RELATED TO ANIMAL

12 TESTING.— 

13 (1) IN GENERAL.—A cosmetic product manu14 facturer shall not include on the label of a cosmetic 

15 product or any of the product’s containers or wrap16 pers a claim that such cosmetic product was not 

17 tested on animals, including any claim or logo of 

18 ‘‘cruelty free’’ if— 

19 (A) such cosmetic product or any ingre20 dient or non-functional constituent contained in 

21 such cosmetic product was tested on an animal 

22 after the effective date specified in subsection 

23 (a); and 

24 (B)(i) the testing was conducted by or con25 tracted for by the cosmetic product manufacVerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141

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1 turer or another person in the supply chain at 

2 the direction or request of the cosmetic product 

3 manufacturer; or 

4 (ii) the cosmetic product manufacturer re5 lied upon evidence from such testing, pursuant 

6 to subsection (c)(1)(B)(ii), to establish the safe7 ty of such product, ingredient, or nonfunctional 

8 constituent under chapter VI of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 361 

10 et seq.). 

11 (2) EXCEPTIONS.—Notwithstanding paragraph 

12 (1), a cosmetic product manufacturer may include a 

13 claim described in such paragraph on the label of a 

14 cosmetic product described in such paragraph or any 

15 of the product’s containers or wrappers if— 

16 (A) such testing qualifies for the exemp17 tion under subsection (d)(4); and 

18 (B)(i) in the case of animal testing con19 ducted by or contracted for by the cosmetic 

20 product manufacturer or another person in the 

21 supply chain at the direction or request of the 

22 cosmetic product manufacturer, the cosmetic 

23 manufacturer did not rely upon evidence from 

24 such testing for the purpose of establishing the 

25 safety of the product, ingredient, or nonfuncVerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141

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1 tional constituent under chapter VI of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

3 361 et seq.); or 

4 (ii) in the case of animal testing conducted 

5 by or contracted for by a person that is not de6 scribed in clause (i), evidence from which the 

7 cosmetic product manufacturer relied upon, 

8 pursuant to subsection (c)(1)(B)(ii), to estab9 lish the safety of such product, ingredient, or 

10 nonfunctional constituent under chapter VI of 

11 the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 361 et seq.), the cosmetic product man13 ufacturer includes on the label a disclosure de14 scribing the circumstances surrounding the use 

15 of the exemption under subsection (c)(1)(B)(ii) 

16 by such manufacturer that includes a reference 

17 to the specific Federal, State, or foreign re18 quirement under which the animal testing was 

19 conducted or a reference to a publicly available 

20 internet website of such manufacturer that pro21 vides such disclosure. 

22 (l) REPORT.—Beginning 2 years after the date of en23 actment of this Act, the Secretary shall biennially submit 

24 to the Committee on Health, Education, Labor, and Pen25 sions of the Senate and the Committee on Energy and 


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1 Commerce of the House of Representatives, and make 

2 available on the internet website of the Food and Drug 

3 Administration, a report that includes, with respect to the 

4 previous 2 fiscal years— 

5 (1) updates on the Secretary’s implementation 

6 of this section, including developments implementing 

7 the strategic plan under subsection (i)(1)(A); 

8 (2) the number of times the Secretary re9 quested animal test data as set forth in subsection 

10 (d)(2), the ingredients involved, and the animal tests 

11 performed; and 

12 (3) based on the data reviewed by the Secretary 

13 under subsection (g)(1), the number of times manu14 facturers relied upon data pursuant to the exemp15 tion under subsection (d)(4) to establish the safety 

16 of a cosmetic under chapter VI of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.). 

Æ 


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