,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #bhhf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,novemb] #ah1 #bjai,ms4
 ,mc,sally 7= h]self1 ,mr4 ,book]1 ,mr4 
,portman1 & ,mr4 ,:iteh\se7 introduc$ ! 
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
prohibit ! use ( animal te/+ = cosmetics
 & ! sale ( cosmetics te/$ on animals4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,humane ,cosmetics ,act ( #bjai4  #b4 
,animal te/+  7a7 ,prohibition on animal
 te/+ ,beg9n+ #a ye> aft] ! date (      
enactm5t ( ?is ,act1 x %all be unlawful 
= any p]son1 :e!r private or gov]nm5tal1
 to kn[+ly conduct or contract =        
cosmetic animal te/+ t occurs 9 ! ,unit$
 ,/ates4  7b7 ,prohibition on sale or   
transport ,x %all be unlawful to sell1  
(f] = sale1 or kn[+ly transport 9       
int]/ate comm]ce 9 ! ,unit$ ,/ates any  
cosmetic t 0 develop$ or manufactur$ us+
 cosmetic animal te/+ t 0 conduct$ or   
contract$ = by any p]son 9 ! cosmetic   

product's supply *a9 aft] ! date t is #a
 ye> aft] ! date ( enactm5t ( ?is ,act4 
7c7 ,data use  7#a7 ,9 g5]al ,no evid5ce
 d]iv$ f animal te/+ conduct$ aft] !    
effective date specifi$ 9 subsection 7a7
 may be reli$ ^u to e/abli% ! safety ( a
 cosmetic1 cosmetic +r$i5t1 or          
non-functional con/itu5t "u ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq471 unless--  7,a7 
9 ! case ( su* te/+ on an +r$i5t or     
non-functional con/itu5t1 !re is no     
non-animal alt]native me?od or /rategy  
recogniz$ by any ,f$]al ag5cy or !      
,organisation = ,economic ,co-op]ation &
 ,developm5t = ! relevant safety        
endpo9ts = su* +r$i5t or non-functional 
con/itu5t2 &  7,b7 7i7 su* animal te/+  
is subject to an exemption "u p>agraph  
7#b7 or 7#c7 ( subsection 7d72 or  7ii7 
7,i7 su* animal te/+ is subject to an   
exemption "u p>agraph 7#d7 ( subsection 
7d72  7,,ii7 !re is docum5t$ evid5ce ( !
 non-cosmetic int5t ( ! te/2 &  7,,iii7 
!re is a hi/ory ( use ( ! +r$i5t outside

 ( cosmetics at lea/ #a ye> prior to !  
reliance on su* data4  7#b7 ,limitation 
,?is section %all n be con/ru$ to       
prohibit any entity f review+1 assess+1 
or reta9+ evid5ce g5]at$ f animal te/+4 
7d7 ,exemptions ,subsections 7a7 & 7b7  
%all n apply ) respect to animal te/+-- 
7#a7 conduct$ outside ! ,unit$ ,/ates 9 
ord] to comply ) a requirem5t f a =eign 
regulatory au?ority2  7#b7 reque/$1     
requir$1 or conduct$ by ! ,secret>y1    
foll[+-- 7,a7 a writt5 f9d+ by !        
,secret>y t--  7i7 !re is no non-animal 
alt]native me?od or /rategy recogniz$ by
 any ,f$]al ag5cy or ! ,organisation =  
,economic ,co-op]ation & ,developm5t = !
 relevant safety endpo9ts = ! cosmetic  
+r$i5t or non-functional con/itu5t2     
7ii7 ! cosmetic +r$i5t or non-functional
 con/itu5t poses a risk ( caus+ s]i\s   
adv]se heal? consequ5ces or dea?2 &     
7iii7 ! cosmetic +r$i5t or              
non-functional con/itu5t is 9 wide use  
&1 9 ! case ( a cosmetic +r$i5t1 _c be  
replac$ by ano!r cosmetic +r$i5t capable

 ( p]=m+ a simil> function2  7,b7       
publication by ! ,secret>y ( ! writt5   
f9d+ requir$ by subp>agraph 7,a7 on !   
int]net website ( ! ,food & ,drug       
,adm9i/ration toge!r ) a notice t !     
,secret>y int5ds to reque/1 require1 or 
conduct new animal te/+1 & provides a   
p]iod ( n less ?an #fj cal5d> days =    
public comm5t2 &  7,c7 a writt5         
det]m9ation by ! ,secret>y1 aft] review 
( all public comm5ts receiv$ pursuant to
 subp>agraph 7,b71 t no previ\sly g5]at$
 data t c\ld be sub/itut$ =1 or o!rwise 
det]m9$ suffici5t to replace1 ! data    
expect$ to be produc$ ?r\gh new animal  
te/+ is available = review by !         
,secret>y2  7#c7 conduct$ = any product 
or +r$i5t t is subject to regulation "u 
*apt] ,v ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq472 or  7#d7 conduct$ = non-cosmetic 
purposes pursuant to a requirem5t ( a   
,f$]al1 ,/ate1 or =eign regulatory      
au?ority4  7e7 ,rule ( con/ruction ,) ! 
exception ( records or o!r in=mation    

demon/rat+ compliance ) subsection      
7c77#a77;,b77ii71 no?+ 9 ?is section    
%all be con/ru$ to au?orize ! ,secret>y 
to impose any new recordkeep+           
requirem5ts relat+ to cosmetic animal   
te/+4  7f7 ,civil p5alties  7#a7 ,9     
g5]al ,9 addition to any o!r p5alties   
applicable "u law1 ! ,secret>y %all     
assess :oev] violates any provision (   
?is section a civil p5alty ( n m ?an    
#aj1jjj = ea* su* violation4  7#b7      
,multiple violations ,ea* violation (   
?is section ) respect to a sep>ate      
animal1 & ea* day t a violation ( ?is   
,act cont9ues1 con/itutes a sep>ate     
(f5se4  7g7 ,records access  7#a7 ,9    
g5]al ,! ,secret>y may reque/ any       
records or o!r in=mation f a cosmetic   
manufactur] t su* manufactur] reli$ ^u  
to meet ! crit]ia 9 subsection          
7c77#a77;,b77ii74 ,su* manufactur] %all1
 ^u su* reque/ ( ! ,secret>y 9 writ+1   
provide to ! ,secret>y su* records or   
o!r in=mation1 )9 a reasonable          
timeframe1 )9 reasonable limits1 & 9 a  

reasonable mann]1 & 9 ei!r electronic or
 physical =m1 at ! exp5se ( su*         
manufactur]4 ,! ,secret>y's reque/ %all 
include a suffici5t description ( !     
records reque/$ & ref]5ce ?is           
subsection4  7#b7 ,confirmation (       
receipt ,^u receipt ( ! records reque/$ 
"u p>agraph 7#a71 ! ,secret>y %all      
provide to ! manufactur] confirmation ( 
receipt4  7#c7 ,inspection au?ority     
,no?+ 9 ?is subsection supplants !      
au?ority ( ! ,secret>y to conduct       
inspections o!rwise p]mitt$ "u ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq474  7h7 ,/ate     
au?ority ,no ,/ate or political         
subdivision ( a ,/ate may e/abli% or    
cont9ue 9 effect any prohibition relat+ 
to cosmetic animal te/+1 or to !        
regulation ( data use1 label+1 & packag+
 relat$ to animal te/+1 t is n id5tical 
to ! prohibitions set =? 9 subsections  
7a71 7b71 7c71 & 7k7 & t does n include 
! exemptions conta9$ 9 subsections 7c71 
7d71 & 7k74 ,no ,/ate or political      

subdivision ( a ,/ate may require any   
entity to p]=m cosmetic animal te/+ t is
 n p]mitt$ by subsection 7a74  7i7 ,,fda
 /rategic plan = non-,animal te/ me?ods 
7#a7 ,sci5tific innovation ,to promote !
 developm5t & provide = exp$it$ review &
 acceptance ( new sci5tifically valid   
te/ me?ods & /rategies t are n bas$ on  
v]tebrate animals1 ! ,secret>y %all--   
7,a7 n lat] ?an #a ye> aft] ! date (    
enactm5t ( ?is ,act1 develop & publi% on
 ! int]net website ( ! ,food & ,drug    
,adm9i/ration a /rategic plan to promote
 ! developm5t & implem5tation (         
alt]native te/ me?ods & /rategies to    
replace v]tebrate animal te/+ = assess+ 
! safety ( cosmetics2  7,b7 provide a   
p]iod ( n less ?an #fj cal5d> days =    
public comm5t reg>d+ su* /rategic plan2 
7,c7 include 9 ! /rategic plan develop$ 
"u subp>agraph 7,a7 a li/1 :i* !        
,secret>y %all update on a regul> basis1
 ( sci5tifically reliable & relevant    
non-animal te/ me?odology z alt]natives 
to animal te/+ t h be5 recogniz$ by any 

,f$]al ag5cy or an int]national         
regulatory ag5cy1 :i* also includes next
 g5]ation risk assessm5t me?ods1 & a li/
 ( examples ( alt]native me?ods &       
/rategies t h be5 accept$ by ! ,secret>y
 7su* li/s %all be = in=mation purposes 
& %all n be deem$ to con/itute a li/ ( !
 only acceptable non-animal te/ me?ods72
 &  7,d7 to ! maximum ext5t practicable 
) available res\rces1 prioritize & c>ry 
out p]=mance assessm5t1 validation1 &   
translational /udies to accel]ate !     
developm5t ( sci5tifically valid te/    
me?ods & /rategies t replace ! use (    
v]tebrate animals4  7#b7 ,public meet+s 
7,a7 ,initial meet+ ,no lat] ?an #ij    
days aft] ! date ( enactm5t ( ?is ,act1 
! ,secret>y %all conv5e a public meet+  
reg>d+ ! /rategic plan describ$ 9       
p>agraph 7#a77;,a74  7,b7 ,subsequ5t    
annual meet+s ,no lat] ?an #a ye> aft] !
 date ( ! public meet+ "u subp>agraph   
7,a71 & annually !reaft]1 ! ,secret>y   
%all conv5e a public meet+ to in=m !    
,secret>y's advancem5t ( alt]native te/ 

me?ods & /rategies to replace v]tebrate 
animal te/+ = assess+ ! safety (        
cosmetics4 ,! ,secret>y %all include 9  
su* meet+s sci5tific & academic exp]ts1 
animal & consum] advocacy gr\ps1 & !    
regulat$ indu/ry4  7#c7 ,rule (         
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ to limit ! au?ority ( !      
,secret>y to address o!r tools to       
promote ! developm5t & implem5tation (  
alt]native te/ me?ods & /rategies to    
replace v]tebrate animal te/+ = assess+ 
! safety ( cosmetics z "p ( ! /rategic  
plan describ$ 9 p>agraph 7#a77;,a74  7j7
 ,def9itions  7#a7 ,cosmetic ,! t]m     
cosmetic has ! mean+ giv5 su* t]m 9     
section #bja7;i7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7;i774  7#b7 ,cosmetic animal te/+  
,! t]m cosmetic animal te/+ means !     
int]nal or ext]nal application or       
exposure ( any cosmetic product1 or any 
cosmetic +r$i5t or non-functional       
con/itu5t1 to ! sk91 eyes1 or o!r body  
"p 7organ or extremity7 ( a live        

non-human v]tebrate = ! purpose (       
evaluat+ ! safety or efficacy ( a       
cosmetic product or a cosmetic +r$i5t or
 non-functional con/itu5t = use 9 a     
cosmetic product4  7#c7 ,label ,! t]m   
label has ! mean+ giv5 su* t]m 9 section
 #bja7k7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cba7k774 
7#d7 ,non-functional con/itu5t ,! t]m   
non-functional con/itu5t means any      
incid5tal +r$i5t z def9$ 9 section      
#gja4c7a7 ( title #ba1 ,code ( ,f$]al   
,regulations1 on ! date ( enactm5t ( ?is
 section4  7#e7 ,secret>y ,! t]m        
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices4  7k7 ,consum] in=mation
 relat$ to animal te/+  7#a7 ,9 g5]al ,a
 cosmetic product manufactur] %all n    
include on ! label ( a cosmetic product 
or any ( ! product's conta9]s or wrapp]s
 a claim t su* cosmetic product 0 n te/$
 on animals1 includ+ any claim or logo (
 cruelty free if--  7,a7 su* cosmetic   
product or any +r$i5t or non-functional 
con/itu5t conta9$ 9 su* cosmetic product

 0 te/$ on an animal aft] ! effective   
date specifi$ 9 subsection 7a72 &  7,b7 
7i7 ! te/+ 0 conduct$ by or contract$ = 
by ! cosmetic product manufactur] or    
ano!r p]son 9 ! supply *a9 at !         
direction or reque/ ( ! cosmetic product
 manufactur]2 or  7ii7 ! cosmetic       
product manufactur] reli$ ^u evid5ce f  
su* te/+1 pursuant to subsection        
7c77#a77;,b77ii71 to e/abli% ! safety ( 
su* product1 +r$i5t1 or nonfunctional   
con/itu5t "u *apt] ,,vi ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfa et seq474  7#b7          
,exceptions ,not)/&+ p>agraph 7#a71 a   
cosmetic product manufactur] may include
 a claim describ$ 9 su* p>agraph on !   
label ( a cosmetic product describ$ 9   
su* p>agraph or any ( ! product's       
conta9]s or wrapp]s if--  7,a7 su* te/+ 
qualifies = ! exemption "u subsection   
7d77#d72 &  7,b7 7i7 9 ! case ( animal  
te/+ conduct$ by or contract$ = by !    
cosmetic product manufactur] or ano!r   
p]son 9 ! supply *a9 at ! direction or  

reque/ ( ! cosmetic product manufactur]1
 ! cosmetic manufactur] did n rely ^u   
evid5ce f su* te/+ = ! purpose (        
e/abli%+ ! safety ( ! product1 +r$i5t1  
or nonfunctional con/itu5t "u *apt] ,,vi
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfa et seq472 or   
7ii7 9 ! case ( animal te/+ conduct$ by 
or contract$ = by a p]son t is n        
describ$ 9 clause 7i71 evid5ce f :i* !  
cosmetic product manufactur] reli$ ^u1  
pursuant to subsection 7c77#a77;,b77ii71
 to e/abli% ! safety ( su* product1     
+r$i5t1 or nonfunctional con/itu5t "u   
*apt] ,,vi ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et   
seq471 ! cosmetic product manufactur]   
includes on ! label a disclosure        
describ+ ! circum/ances surr\nd+ ! use (
 ! exemption "u subsection              
7c77#a77;,b77ii7 by su* manufactur] t   
includes a ref]5ce to ! specific ,f$]al1
 ,/ate1 or =eign requirem5t "u :i* !    
animal te/+ 0 conduct$ or a ref]5ce to a
 publicly available int]net website (   

su* manufactur] t provides su*          
disclosure4  7l7 ,report ,beg9n+ #b ye>s
 aft] ! date ( enactm5t ( ?is ,act1 !   
,secret>y %all bi5nially submit to !    
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 & make         
available on ! int]net website ( ! ,food
 & ,drug ,adm9i/ration1 a report t      
includes1 ) respect to ! previ\s #b     
fiscal ye>s--  7#a7 updates on !        
,secret>y's implem5tation ( ?is section1
 includ+ developm5ts implem5t+ !        
/rategic plan "u subsection             
7i77#a77;,a72  7#b7 ! numb] ( times !   
,secret>y reque/$ animal te/ data z set 
=? 9 subsection 7d77#b71 ! +r$i5ts      
involv$1 & ! animal te/s p]=m$2 &  7#c7 
bas$ on ! data review$ by ! ,secret>y "u
 subsection 7g77#a71 ! numb] ( times    
manufactur]s reli$ ^u data pursuant to !
 exemption "u subsection 7d77#d7 to     
e/abli% ! safety ( a cosmetic "u *apt]  
,,vi ( ! ,f$]al ,food1 ,drug1 &         

,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et   
seq474