,,ii  #aai? ,,congress  #a/ ,session    
,s4 #aijf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bb1 #bjbe,mr4    
,m>%all 7= himself1 ,ms4 ,baldw91 ,mr4  
,moran1 ,mr4 ,b5net1 ,mr4 ,grassley1    
,mr4 ,k+1 & ,ms4 ,klobu*>7 introduc$ !  
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,agriculture1        
,nutrition1 & ,=e/ry  ,a ,,bill  ,to    
am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic 
,act ) respect to ! regulation (        
zoote*nical animal food sub/ances4  #a4 
,%ort title ,?is ,act may be cit$ z !   
,innovative ,fe$ ,enhancem5t & ,economic
 ,developm5t ,act ( #bjbe or !          
,innovative ,,fe$ ,act ( #bjbe4  #b4    
,regulation ( zoote*nical animal food   
sub/ances  7a7 ,def9ition ,section #bja 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cba7 is am5d$ by   
add+ at ! end ! foll[+3  7tt7 7#a7 ,!   
t]m zoote*nical animal food sub/ance    
means a sub/ance t-- 7,a7 is add$ to !  
food or dr9k+ wat] ( animals2  7,b7 is  
int5d$ to-- 7i7 affect ! byproducts ( ! 

dige/ive process ( an animal2  7ii7     
r$uce ! pres5ce ( foodborne pa?og5s (   
human heal? significance 9 an animal    
int5d$ to be us$ = food2 or  7iii7      
affect ! /ructure or function ( ! body (
 ! animal1 o!r ?an by provid+ nutritive 
value1 by alt]+ ! animal's ga/ro9te/9al 
microbiome2 &  7,c7 a*ieves its int5d$  
effect by act+ solely )9 ! ga/ro9te/9al 
tract ( ! animal4  7#b7 ,su* t]m does n 
include a sub/ance t-- 7,a7 is int5d$ = 
use 9 ! diagnosis1 cure1 mitigation1    
treatm5t1 or prev5tion ( disease 9 an   
animal2  7,b7 is a hormone2  7,c7 is an 
active moiety 9 an animal drug1 :i*1    
prior to ! fil+ ( a petition "u section 
#dji1 0 approv$ "u section #eab1        
conditionally approv$ "u section #ega1  
index$ "u section #egb1 or = :i*        
sub/antial cl9ical inve/igations h be5  
in/itut$ & = :i* ! exi/5ce ( su*        
inve/igations has be5 made public2  7,d7
 is an ionophore2 or  7,e7 is o!rwise   
exclud$ f ! def9ition bas$ on crit]ia   
e/abli%$ by ! ,secret>y ?r\gh notice &  

comm5t rulemak+4  7#c7 ,a zoote*nical   
animal food sub/ance %all be deem$ to be
 a food additive )9 ! mean+ ( p>agraph  
7s7 & its introduction into int]/ate    
comm]ce %all be 9 accordance ) a        
regulation issu$ "u section #dji4 ,a    
zoote*nical animal food sub/ance %all n 
be consid]$ a drug "u p>agraph          
7g77#a77;,c7 solely because ! sub/ance  
has an int5d$ effect describ$ 9         
subp>agraph 7#a74  4  7b7 ,food         
additives ,section #dji ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cdh7 is am5d$-- 7#a7 9       
subsection 7b7-- 7,a7 by r$esignat+     
p>agraphs 7#c7 ?r\gh 7#e7 z p>agraphs   
7#d7 ?r\gh 7#f71 respectively2 &  7,b7  
by ins]t+ aft] p>agraph 7#b7 ! foll[+3  
7#c7 ,9 ! case ( a zoote*nical animal   
food sub/ance1 su* petition %all1 9     
addition to any explanatory or support+ 
data1 conta9-- 7,a7 all relevant data   
be>+ on ! effect ! zoote*nical animal   
food sub/ance is int5d$ to h & !        
quantity ( su* sub/ance requir$ to      

produce ! int5d$ effect2 &  7,b7 full   
reports ( inve/igations made ) respect  
to ! int5d$ use ( su* sub/ance1 includ+ 
full in=mation z to ! me?ods & controls 
us$ 9 conduct+ su* inve/igations4  2    
7#b7 9 subsection 7c7-- 7,a7 by am5d+   
subp>agraph 7,a7 ( p>agraph 7#a7 to read
 z foll[s3  7,a7 7i7 by ord] e/abli% a  
regulation 7:e!r or n 9 accord ) t      
propos$ by ! petition]7 prescrib+-- 7,i7
 ) respect to "o or m propos$ uses ( !  
food additive involv$1 ! conditions "u  
:i* su* additive may be safely us$      
7includ+ specifications z to ! p>ticul> 
food or classes ( food 9 or on :i* su*  
additive may be us$1 ! maximum quantity 
:i* may be us$ or p]mitt$ to rema9 9 or 
on su* food1 ! mann] 9 :i* su* additive 
may be add$ to or us$ 9 or on su* food1 
& any directions or o!r label+ or       
packag+ requirem5ts = su* additive z !  
,secret>y det]m9es necess>y to assure ! 
safety ( su* use72 &  7,,ii7 9 ! case ( 
a zoote*nical animal food sub/ance1 !   
conditions "u :i* su* sub/ance may be   

us$ to a*ieve ! int5d$ effect2 &  7ii7  
notify ! petition] ( su* ord] & !       
reasons = su* action2 or  2 &  7,b7 9   
p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 
by /rik+ 2 or & ins]t+ a semicolon2     
7ii7 9 subp>agraph 7,b71 by /rik+ !     
p]iod & ins]t+ 2 or2 &  7iii7 by add+ at
 ! end ! foll[+3  7,c7 9 ! case ( a     
zoote*nical animal food sub/ance1 fails 
to e/abli% t ! propos$ use ( ! sub/ance1
 "u ! conditions ( use to be specifi$ 9 
! regulation1 w a*ieve ! int5d$ effect4 
2 &  7#c7 by add+ at ! end ! foll[+3    
7l7 ,zoote*nical animal food sub/ances  
,! label+ ( a zoote*nical animal food   
sub/ance-- 7#a7 %all include ! /atem5t3 
,n = use 9 ! diagnosis1 cure1           
mitigation1 treatm5t1 or prev5tion (    
disease 9 animals42 &  7#b7 may include 
/atem5ts reg>d+ ! int5d$ effect ( !     
sub/ance on ! /ructure or function ( !  
body ( animals1 z set =? 9 section      
#bja7tt77#a74  4  7c7 ,misbr&$ food     
,section #djc ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is 

am5d$ by add+ at ! end ! foll[+3  7z7   
,if x is a zoote*nical animal food      
sub/ance & ! label+ ( ! food does n     
include ! /atem5t requir$ by section    
#dji7l77#a74  4  7d7 ,rule ( con/ruction
 ,no?+ 9 ?is section1 or ! am5dm5ts made
 by ?is section1 %all be con/ru$ to     
au?orize ! ,secret>y ( ,heal? & ,human  
,s]vices to require ! use ( any         
zoote*nical food sub/ance or food       
additive 7z ^? t]ms are def9$ 9 section 
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act1 z am5d$ by subsection   
7a774