Humane Cosmetics Act of 2019

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Humane Cosmetics 4 Act of 2019’’. 5 SEC. 2. ANIMAL TESTING. 6 (a) PROHIBITION ON ANIMAL TESTING.—Beginning 7 1 year after the date of enactment of this Act, it shall 8 be unlawful for any person, whether private or govern- 9 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 2 •HR 5141 IH mental, to knowingly conduct or contract for cosmetic ani- 1 mal testing that occurs in the United States. 2 (b) PROHIBITION ON SALE OR TRANSPORT.—It shall 3 be unlawful to sell, offer for sale, or knowingly transport 4 in interstate commerce in the United States any cosmetic 5 that was developed or manufactured using cosmetic ani- 6 mal testing that was conducted or contracted for by any 7 person in the cosmetic product’s supply chain after the 8 date that is 1 year after the date of enactment of this 9 Act. 10 (c) DATA USE.— 11 (1) IN GENERAL.—No evidence derived from 12 animal testing conducted after the effective date 13 specified in subsection (a) may be relied upon to es- 14 tablish the safety of a cosmetic, cosmetic ingredient, 15 or non-functional constituent under the Federal 16 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 17 seq.), unless— 18 (A) in the case of such testing on an ingre- 19 dient or non-functional constituent, there is no 20 non-animal alternative method or strategy rec- 21 ognized by any Federal agency or the 22 Organisation for Economic Co-operation and 23 Development for the relevant safety endpoints 24 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 3 •HR 5141 IH for such ingredient or non-functional con- 1 stituent; and 2 (B)(i) such animal testing is subject to an 3 exemption under paragraph (2) or (3) of sub- 4 section (d); or 5 (ii)(I) such animal testing is subject to an 6 exemption under paragraph (4) of subsection 7 (d); 8 (II) there is documented evidence of the 9 non-cosmetic intent of the test; and 10 (III) there is a history of use of the ingre- 11 dient outside of cosmetics at least 1 year prior 12 to the reliance on such data. 13 (2) LIMITATION.—This section shall not be con- 14 strued to prohibit any entity from reviewing, assess- 15 ing, or retaining evidence generated from animal 16 testing. 17 (d) EXEMPTIONS.—Subsections (a) and (b) shall not 18 apply with respect to animal testing— 19 (1) conducted outside the United States in 20 order to comply with a requirement from a foreign 21 regulatory authority; 22 (2) requested, required, or conducted by the 23 Secretary, following— 24 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 4 •HR 5141 IH (A) a written finding by the Secretary 1 that— 2 (i) there is no non-animal alternative 3 method or strategy recognized by any Fed- 4 eral agency or the Organisation for Eco- 5 nomic Co-operation and Development for 6 the relevant safety endpoints for the cos- 7 metic ingredient or non-functional con- 8 stituent; 9 (ii) the cosmetic ingredient or non- 10 functional constituent poses a risk of caus- 11 ing serious adverse health consequences or 12 death; and 13 (iii) the cosmetic ingredient or non- 14 functional constituent is in wide use and, 15 in the case of a cosmetic ingredient, cannot 16 be replaced by another cosmetic ingredient 17 capable of performing a similar function; 18 (B) publication by the Secretary of the 19 written finding required by subparagraph (A) 20 on the internet website of the Food and Drug 21 Administration together with a notice that the 22 Secretary intends to request, require, or con- 23 duct new animal testing, and provides a period 24 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 5 •HR 5141 IH of not less than 60 calendar days for public 1 comment; and 2 (C) a written determination by the Sec- 3 retary, after review of all public comments re- 4 ceived pursuant to subparagraph (B), that no 5 previously generated data that could be sub- 6 stituted for, or otherwise determined sufficient 7 to replace, the data expected to be produced 8 through new animal testing is available for re- 9 view by the Secretary; 10 (3) conducted for any product or ingredient 11 that is subject to regulation under chapter V of the 12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 13 351 et seq.); or 14 (4) conducted for non-cosmetic purposes pursu- 15 ant to a requirement of a Federal, State, or foreign 16 regulatory authority. 17 (e) RULE OF CONSTRUCTION.—With the exception of 18 records or other information demonstrating compliance 19 with subsection (c)(1)(B)(ii), nothing in this section shall 20 be construed to authorize the Secretary to impose any new 21 recordkeeping requirements relating to cosmetic animal 22 testing. 23 (f) CIVIL PENALTIES.— 24 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 6 •HR 5141 IH (1) IN GENERAL.—In addition to any other 1 penalties applicable under law, the Secretary shall 2 assess whoever violates any provision of this section 3 a civil penalty of not more than $10,000 for each 4 such violation. 5 (2) MULTIPLE VIOLATIONS.—Each violation of 6 this section with respect to a separate animal, and 7 each day that a violation of this Act continues, con- 8 stitutes a separate offense. 9 (g) RECORDS ACCESS.— 10 (1) IN GENERAL.—The Secretary may request 11 any records or other information from a cosmetic 12 manufacturer that such manufacturer relied upon to 13 meet the criteria in subsection (c)(1)(B)(ii). Such 14 manufacturer shall, upon such request of the Sec- 15 retary in writing, provide to the Secretary such 16 records or other information, within a reasonable 17 timeframe, within reasonable limits, and in a reason- 18 able manner, and in either electronic or physical 19 form, at the expense of such manufacturer. The Sec- 20 retary’s request shall include a sufficient description 21 of the records requested and reference this sub- 22 section. 23 (2) CONFIRMATION OF RECEIPT.—Upon receipt 24 of the records requested under paragraph (1), the 25 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 7 •HR 5141 IH Secretary shall provide to the manufacturer con- 1 firmation of receipt. 2 (3) INSPECTION AUTHORITY.—Nothing in this 3 subsection supplants the authority of the Secretary 4 to conduct inspections otherwise permitted under the 5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 6 301 et seq.). 7 (h) STATE AUTHORITY.—No State or political sub- 8 division of a State may establish or continue in effect any 9 prohibition relating to cosmetic animal testing, or to the 10 regulation of data use, labeling, and packaging related to 11 animal testing, that is not identical to the prohibitions set 12 forth in subsections (a), (b), (c), and (k) and that does 13 not include the exemptions contained in subsections (c), 14 (d), and (k). No State or political subdivision of a State 15 may require any entity to perform cosmetic animal testing 16 that is not permitted by subsection (a). 17 (i) FDA STRATEGIC PLAN FOR NON-ANIMAL TEST 18 METHODS.— 19 (1) SCIENTIFIC INNOVATION.—To promote the 20 development and provide for expedited review and 21 acceptance of new scientifically valid test methods 22 and strategies that are not based on vertebrate ani- 23 mals, the Secretary shall— 24 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 8 •HR 5141 IH (A) not later than 1 year after the date of 1 enactment of this Act, develop and publish on 2 the internet website of the Food and Drug Ad- 3 ministration a strategic plan to promote the de- 4 velopment and implementation of alternative 5 test methods and strategies to replace verte- 6 brate animal testing for assessing the safety of 7 cosmetics; 8 (B) provide a period of not less than 60 9 calendar days for public comment regarding 10 such strategic plan; 11 (C) include in the strategic plan developed 12 under subparagraph (A) a list, which the Sec- 13 retary shall update on a regular basis, of sci- 14 entifically reliable and relevant non-animal test 15 methodology as alternatives to animal testing 16 that have been recognized by any Federal agen- 17 cy or an international regulatory agency, which 18 also includes next generation risk assessment 19 methods, and a list of examples of alternative 20 methods and strategies that have been accepted 21 by the Secretary (such lists shall be for infor- 22 mation purposes and shall not be deemed to 23 constitute a list of the only acceptable non-ani- 24 mal test methods); and 25 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 9 •HR 5141 IH (D) to the maximum extent practicable 1 with available resources, prioritize and carry 2 out performance assessment, validation, and 3 translational studies to accelerate the develop- 4 ment of scientifically valid test methods and 5 strategies that replace the use of vertebrate ani- 6 mals. 7 (2) PUBLIC MEETINGS.— 8 (A) INITIAL MEETING.—No later than 90 9 days after the date of enactment of this Act, 10 the Secretary shall convene a public meeting re- 11 garding the strategic plan described in para- 12 graph (1)(A). 13 (B) SUBSEQUENT ANNUAL MEETINGS.— 14 No later than 1 year after the date of the pub- 15 lic meeting under subparagraph (A), and annu- 16 ally thereafter, the Secretary shall convene a 17 public meeting to inform the Secretary’s ad- 18 vancement of alternative test methods and 19 strategies to replace vertebrate animal testing 20 for assessing the safety of cosmetics. The Sec- 21 retary shall include in such meetings scientific 22 and academic experts, animal and consumer ad- 23 vocacy groups, and the regulated industry. 24 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 10 •HR 5141 IH (3) RULE OF CONSTRUCTION.—Nothing in this 1 subsection shall be construed to limit the authority 2 of the Secretary to address other tools to promote 3 the development and implementation of alternative 4 test methods and strategies to replace vertebrate 5 animal testing for assessing the safety of cosmetics 6 as part of the strategic plan described in paragraph 7 (1)(A). 8 (j) DEFINITIONS.— 9 (1) COSMETIC.—The term ‘‘cosmetic’’ has the 10 meaning given such term in section 201(i) of the 11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12 321(i)). 13 (2) COSMETIC ANIMAL TESTING.—The term 14 ‘‘cosmetic animal testing’’ means the internal or ex- 15 ternal application or exposure of any cosmetic prod- 16 uct, or any cosmetic ingredient or non-functional 17 constituent, to the skin, eyes, or other body part 18 (organ or extremity) of a live non-human vertebrate 19 for the purpose of evaluating the safety or efficacy 20 of a cosmetic product or a cosmetic ingredient or 21 non-functional constituent for use in a cosmetic 22 product. 23 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 11 •HR 5141 IH (3) LABEL.—The term ‘‘label’’ has the meaning 1 given such term in section 201(k) of the Federal 2 Food, Drug, and Cosmetic Act (21 U.S.C. 321(k)). 3 (4) NON-FUNCTIONAL CONSTITUENT.—The 4 term ‘‘non-functional constituent’’ means any inci- 5 dental ingredient as defined in section 701.3(1) of 6 title 21, Code of Federal Regulations, on the date of 7 enactment of this section. 8 (5) SECRETARY.—The term ‘‘Secretary’’ means 9 the Secretary of Health and Human Services. 10 (k) CONSUMER INFORMATION RELATED TO ANIMAL 11 TESTING.— 12 (1) IN GENERAL.—A cosmetic product manu- 13 facturer shall not include on the label of a cosmetic 14 product or any of the product’s containers or wrap- 15 pers a claim that such cosmetic product was not 16 tested on animals, including any claim or logo of 17 ‘‘cruelty free’’ if— 18 (A) such cosmetic product or any ingre- 19 dient or non-functional constituent contained in 20 such cosmetic product was tested on an animal 21 after the effective date specified in subsection 22 (a); and 23 (B)(i) the testing was conducted by or con- 24 tracted for by the cosmetic product manufac- 25 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 12 •HR 5141 IH turer or another person in the supply chain at 1 the direction or request of the cosmetic product 2 manufacturer; or 3 (ii) the cosmetic product manufacturer re- 4 lied upon evidence from such testing, pursuant 5 to subsection (c)(1)(B)(ii), to establish the safe- 6 ty of such product, ingredient, or nonfunctional 7 constituent under chapter VI of the Federal 8 Food, Drug, and Cosmetic Act (21 U.S.C. 361 9 et seq.). 10 (2) EXCEPTIONS.—Notwithstanding paragraph 11 (1), a cosmetic product manufacturer may include a 12 claim described in such paragraph on the label of a 13 cosmetic product described in such paragraph or any 14 of the product’s containers or wrappers if— 15 (A) such testing qualifies for the exemp- 16 tion under subsection (d)(4); and 17 (B)(i) in the case of animal testing con- 18 ducted by or contracted for by the cosmetic 19 product manufacturer or another person in the 20 supply chain at the direction or request of the 21 cosmetic product manufacturer, the cosmetic 22 manufacturer did not rely upon evidence from 23 such testing for the purpose of establishing the 24 safety of the product, ingredient, or nonfunc- 25 VerDate Sep 11 2014 03:28 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5141.IH H5141 kjohnson on DSK79L0C42 with BILLS 13 •HR 5141 IH tion [Text truncated for display. Full text available on Congress.gov.]