,,ii  #aafth ,,congress  #ast ,session  
,s4 #bhhf  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,november #ah1 
#bjai,ms4 ,mc,sally 7for herself1 ,mr4  
,booker1 ,mr4 ,portman1 and ,mr4        
,whitehouse7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to prohibit the use of animal  
testing for cosmetics and the sale of   
cosmetics tested on animals4  #a4 ,short
 title ,this ,act may be cited as the   
,humane ,cosmetics ,act of #bjai4  #b4  
,animal testing  7a7 ,prohibition on    
animal testing ,beginning #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 ,it shall be       
unlawful to sell1 offer for sale1 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 #a year after the date of       
enactment of this ,act4  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 non-functional           
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
 non-functional constituent1 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       

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     
agency or the ,organisation for         
,economic ,co-operation and ,development
 for the relevant safety endpoints for  
the cosmetic ingredient or              
non-functional constituent2  7ii7 the   
cosmetic ingredient or non-functional   
constituent poses a risk of causing     
serious adverse health consequences or  
death2 and  7iii7 the cosmetic          
ingredient or non-functional 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 ,secretary of the    
written finding required by subparagraph
 7,a7 on the internet website of the    
,food and ,drug ,administration together
 with a notice that the ,secretary      
intends to request1 require1 or conduct 
new animal testing1 and provides 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 applicable under
 law1 the ,secretary shall assess       
whoever violates any provision of this  
section a civil penalty of not more than
 #aj1jjj for each such violation4  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 7k7 and  
that does not include the exemptions    
contained in subsections 7c71 7d71 and  
7k74 ,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  
and provide for expedited review and    
acceptance of 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   
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 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 list1 which the     
,secretary shall update on a regular    

basis1 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 agency1  
which also includes next generation risk
 assessment methods1 and a list of      
examples of alternative methods and     
strategies that have been accepted by   
the ,secretary 7such lists shall be for 
information purposes and shall not be   
deemed to constitute a list of the only 
acceptable non-animal test methods72 and
  7,d7 to the maximum extent practicable
 with 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 ,no     
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 ,no later than #a year  
after the date of the public meeting    
under subparagraph 7,a71 and annually   
thereafter1 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 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 ,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  
non-functional 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     
non-functional 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               
,non-functional constituent ,the term   
non-functional constituent means any    
incidental ingredient as defined in     
section #gja4c7a7 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  7k7 ,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            
non-functional 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  7l7     
,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 internet 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 as set forth in 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