,,ii #aagth ,,congress #ast ,session ,s4 #cceg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #i1 #bjba,mr4 ,booker 7for himself1 ,mr4 ,portman1 ,mr4 ,hickenlooper1 ,ms4 ,collins1 and ,ms4 ,rosen7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to substantially restrict the use of animal testing for cosmetics4 #a4 ,short title ,this ,act may be cited as the ,humane ,cosmetics ,act of #bjba4 #b4 ,animal testing 7a7 ,prohibition on animal testing ,beginning on the date that is #a year after the date of enactment of this ,act1 it shall be unlawful for any person1 whether private or governmental1 to knowingly conduct or contract for cosmetic animal testing that occurs in the ,united ,states4 7b7 ,prohibition on sale or transport ,beginning on the date that is #a year after the date of enactment of this ,act1 it shall be unlawful to sell1 offer for sale1 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 date4 7c7 ,data use 7#a7 ,in general ,no evidence derived from animal testing conducted after the effective date specified in subsection 7a7 may be relied upon to establish the safety of a cosmetic1 cosmetic ingredient1 or nonfunctional constituent under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 unless-- 7,a7 in the case of such testing on an ingredient or nonfunctional constituent1 there is no non-animal alternative method or strategy recognized by any ,federal agency1 the ,interagency ,coordinating ,committee on the ,validation of ,alternative ,methods1 or the ,organisation for ,economic ,co-operation and ,development for the relevant safety endpoints for such ingredient or nonfunctional constituent2 and 7,b7 7i7 such animal testing is subject to an exemption under paragraph 7#b7 or 7#c7 of subsection 7d72 or 7ii7 7,i7 such animal testing is subject to an exemption under paragraph 7#d7 of subsection 7d72 7,,ii7 there is documented evidence of the non-cosmetic intent of the test2 and 7,,iii7 there is a history of use of the ingredient outside of cosmetics at least #a year prior to the reliance on such data4 7#b7 ,limitation ,this section shall not be construed to prohibit any entity from reviewing1 assessing1 or retaining evidence generated from animal testing4 7d7 ,exemptions ,subsections 7a7 and 7b7 shall not apply with respect to animal testing-- 7#a7 conducted outside the ,united ,states in order to comply with a requirement from a foreign regulatory authority2 7#b7 requested1 required1 or conducted by the ,secretary1 following-- 7,a7 a written finding by the ,secretary that-- 7i7 there is no non-animal alternative method or strategy recognized by any ,federal agency1 the ,interagency ,coordinating ,committee on the ,validation of ,alternative ,methods1 or the ,organisation for ,economic ,co-operation and ,development for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent2 7ii7 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 constituent2 and 7iii7 the cosmetic ingredient or nonfunctional constituent is in wide use and1 in the case of a cosmetic ingredient1 cannot be replaced by another cosmetic ingredient capable of performing a similar function2 7,b7 publication by the ,secretary1 on the website of the ,food and ,drug ,administration1 of the written finding under subparagraph 7,a7 together with a notice that the ,secretary intends to request1 require1 or conduct new animal testing1 and providing a period of not less than #fj calendar days for public comment2 and 7,c7 a written determination by the ,secretary1 after review of all public comments received pursuant to subparagraph 7,b71 that no previously generated data that could be substituted for1 or otherwise determined sufficient to replace1 the data expected to be produced through new animal testing is available for review by the ,secretary2 7#c7 conducted for any product or ingredient that is subject to regulation under chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq472 or 7#d7 conducted for non-cosmetic purposes pursuant to a requirement of a ,federal1 ,state1 or foreign regulatory authority4 7e7 ,rule of construction ,with the exception of records or other information demonstrating compliance with subsection 7c77#a77;,b77ii71 nothing in this section shall be construed to authorize the ,secretary to impose any new recordkeeping requirements relating to cosmetic animal testing4 7f7 ,civil penalties 7#a7 ,in general ,in addition to any other penalties under applicable law1 any person who violates this section may be subject to a civil penalty in an amount of not more than #aj1jjj for each such violation1 as determined by the ,secretary4 7#b7 ,multiple violations ,each violation of this section with respect to a separate animal1 and each day that a violation of this ,act continues1 constitutes a separate offense4 7g7 ,records access 7#a7 ,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 7c77#a77;,b77ii74 ,such manufacturer shall1 upon such request of the ,secretary in writing1 provide to the ,secretary such records or other information1 within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 and in either electronic or physical form1 at the expense of such manufacturer4 ,the ,secretary's request shall include a sufficient description of the records requested and reference this subsection4 7#b7 ,confirmation of receipt ,upon receipt of the records requested under paragraph 7#a71 the ,secretary shall provide to the manufacturer confirmation of receipt4 7#c7 ,inspection authority ,nothing in this subsection supplants the authority of the ,secretary to conduct inspections otherwise permitted under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7h7 ,state authority ,no ,state or political subdivision of a ,state may establish or continue in effect any prohibition relating to cosmetic animal testing1 or to the regulation of data use1 labeling1 and packaging related to animal testing1 that is not identical to the prohibitions set forth in subsections 7a71 7b71 7c71 and 7j7 and that does not include the exemptions contained in subsections 7c71 7d71 and 7j74 ,no ,state or political subdivision of a ,state may require any entity to perform cosmetic animal testing that is not permitted by subsection 7a74 7i7 ,,fda strategic plan for non-,animal test methods 7#a7 ,scientific innovation ,to promote the development of1 and provide for expedited review and acceptance of1 new scientifically valid test methods and strategies that are not based on vertebrate animals1 the ,secretary shall-- 7,a7 not later than #a year after the date of enactment of this ,act1 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 cosmetics2 7,b7 provide a period of not less than #fj calendar days for public comment regarding such strategic plan2 7,c7 include in the strategic plan developed under subparagraph 7,a7 a list 7which the ,secretary shall update on a regular basis1 and which shall be for informational purposes and shall not be deemed to constitute a list of the only acceptable non-animal test methods7 of-- 7i7 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 agency2 7ii7 next generation risk assessment methods2 and 7iii7 examples of alternative methods and strategies that have been accepted by the ,secretary2 and 7,d7 to the maximum extent practicable given available resources1 prioritize and carry out performance assessment1 validation1 and translational studies to accelerate the development of scientifically valid test methods and strategies that replace the use of vertebrate animals4 7#b7 ,public meetings 7,a7 ,initial meeting ,not later than #ij days after the date of enactment of this ,act1 the ,secretary shall convene a public meeting regarding the strategic plan described in paragraph 7#a77;,a74 7,b7 ,subsequent annual meetings ,not later than #a year after the date of the public meeting under subparagraph 7,a71 and annually thereafter1 the ,secretary shall convene a separate public meeting or add as an agenda item to an already existing meeting1 in-person or virtually1 to inform the ,secretary's advancement of alternative test methods and strategies to replace vertebrate animal testing for assessing the safety of cosmetics4 ,the ,secretary shall include in such meetings scientific and academic experts1 animal and consumer advocacy groups1 and the regulated industry4 7#c7 ,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 7#a77;,a74 7j7 ,consumer information related to animal testing 7#a7 ,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 animals1 including any claim or logo of cruelty free if-- 7,a7 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 7a72 and 7,b7 7i7 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 manufacturer2 or 7ii7 the cosmetic product manufacturer relied upon evidence from such testing1 pursuant to subsection 7c77#a77;,b77ii71 to establish the safety of such product1 ingredient1 or nonfunctional constituent under chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq474 7#b7 ,exceptions ,notwithstanding paragraph 7#a71 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-- 7,a7 such testing qualifies for the exemption under subsection 7d77#d72 and 7,b7 7i7 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 manufacturer1 the cosmetic manufacturer did not rely upon evidence from such testing for the purpose of establishing the safety of the product1 ingredient1 or nonfunctional constituent under chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq472 or 7ii7 in the case of animal testing conducted by or contracted for by a person that is not described in clause 7i71 evidence from which the cosmetic product manufacturer relied upon1 pursuant to subsection 7c77#a77;,b77ii71 to establish the safety of such product1 ingredient1 or nonfunctional constituent under chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq471 the cosmetic product manufacturer includes on the label a disclosure describing the circumstances surrounding the use of the exemption under subsection 7c77#a77;,b77ii7 by such manufacturer that includes a reference to the specific ,federal1 ,state1 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 disclosure4 7k7 ,report ,beginning #b years after the date of enactment of this ,act1 the ,secretary shall biennially submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and make available on the website of the ,food and ,drug ,administration1 a report that includes1 with respect to the previous #b fiscal years-- 7#a7 updates on the ,secretary's implementation of this section1 including developments implementing the strategic plan under subsection 7i77#a77;,a72 7#b7 the number of times the ,secretary requested animal test data under subsection 7d77#b71 the ingredients involved1 and the animal tests performed2 and 7#c7 based on the data reviewed by the ,secretary under subsection 7g77#a71 the number of times manufacturers relied upon data pursuant to the exemption under subsection 7d77#d7 to establish the safety of a cosmetic under chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq474 7l7 ,definitions 7#a7 ,cosmetic ,the term cosmetic has the meaning given such term in section #bja7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;i774 7#b7 ,cosmetic animal testing ,the term cosmetic animal testing means the internal or external application or exposure of any cosmetic product1 or any cosmetic ingredient or nonfunctional constituent1 to the skin1 eyes1 or other body part 7organ or extremity7 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 product4 7#c7 ,label ,the term label has the meaning given such term in section #bja7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7k774 7#d7 ,nonfunctional constituent ,the term nonfunctional constituent means any incidental ingredient as defined in section #gja4c7l7 of title #ba1 ,code of ,federal ,regulations1 on the date of enactment of this section4 7#e7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4