,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #aehg  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #af1 #bjag,ms4   
,slaught] 7= h]self1 ,ms4 ,de,lauro1    
,mr4 ,cicill9e1 ,mr4 ,connolly1 ,mr4    
,de,fazio1 ,mr4 ,deut*1 ,mr4 ,langev91  
,mr4 ,t$ ,lieu ( ,cali=nia1 ,mr4        
,l[5?al1 ,ms4 ,mc,collum1 ,mr4 ,m\lton1 
,mrs4 ,napolitano1 ,ms4 ,norton1 ,ms4   
,spei]1 ,ms4 ,tsongas1 ,mr4 ,y>mu?1 ,mr4
 ,jeffries1 & ,ms4 ,%ea-,port]7         
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to pres]ve !           
effectiv5ess ( m$ically important       
antimicrobials us$ 9 ! treatm5t ( human 
& animal diseases4  #a4 ,%ort title ,?is
 ,act may be cit$ z ! ,pres]vation (    
,antibiotics = ,m$ical ,treatm5t ,act ( 
#bjag4  #b4 ,f9d+s ,! ,congress f9ds !  
foll[+3  7#a7 ,all uses ( antibiotics1  
includ+ = food-produc+ animals1 h !     
pot5tial to cause resi/ance & contribute
 to ! developm5t ( antibiotic-resi/ant  

bact]ial infections 9 p4  7#b7 ,9 #aigg1
 ! ,food & ,drug ,adm9i/ration 7,,fda7  
conclud$ t fe$+ live/ock l[ doses (     
antibiotics us$ 9 human disease treatm5t
 c\ld promote ! developm5t ( antibiotic 
resi/ance 9 bact]ia4 ,h[ev]1 ! ,food &  
,drug ,adm9i/ration did n act 9 response
 to ^! f9d+s1 despite laws requir+ !    
ag5cy to d s4  7#c7 ,9 #bjab1 ! ,food & 
,drug ,adm9i/ration ,guidance = ,indu/ry
 #bji provid$ a summ>y ( ov] #dj ye>s ( 
pe]-review$ sci5tific lit]ature reg>d+  
use ( antimicrobial drugs 9 live/ock :i*
 reit]at$ t ! use ( antibiotics 9       
animals contributes to ! resi/ance 9    
human pa?og5s & concludes t /rategies = 
controll+ antibiotic resi/ance1 includ+ 
limit+ m$ically important antimicrobial 
drugs 9 food-produc+ animals only to    
uses t are consid]$ necess>y = assur+   
animal heal? are ne$$4  7#d7 ,! #bjad   
,presid5t's ,c\ncil ( ,advisors on      
,sci5ce & ,te*nology ,report to !       
,presid5t on ,combat+                   
,antibiotic-,resi/ant ,bact]ia also     

concludes t sub/antial evid5ce exi/s t !
 use ( antibiotics 9 food animals       
promotes ! developm5t & spread (        
antibiotic resi/ance 9 bact]ia t c      
spread to p & t x is cle> t agricultural
 use ( antibiotics c affect human heal?4
  7#e7 ,rec5tly publi%$ sci5tific /udies
 h %[n t food-produc+ animals1 & animal 
production facilities1 are a s\rce (    
antibiotic-resi/ant bact]ia :i* h       
infect$ humans & pres5t an increas$ risk
 ( acquir+ & antibiotics resi/ant       
infection4  7#f7 ,antibiotic resi/ance  
is a crisis :i* ?reat5s public heal?1 ! 
economy1 & national security4  7#g7 ,9  
#bjac1 ! ,c5t]s = ,disease ,control &   
,prev5tion e/imat$ t antibiotic-resi/ant
 infections cause at lea/ #b million    
infections1 #bc1jjj dea?s1 #h million   
additional hospital days1 & #bj to #ce  
billion 9 excess direct heal? c>e co/s  
ea* ye> 9 ! ,unit$ ,/ates4  7#h7 ,!     
#bjad ,_w ,heal? ,organization report1  
,antimicrobial ,resi/ance3 ,global      
,report on ,surveillance #bjad1 conclud$

 t antimicrobial resi/ance is a curr5t  
reality & ! problem is s s]i\s t x      
?reat5s ! a*ievem5ts ( mod]n m$ic9e4    
7#i7 ,)\t effective antibiotics-- 7,a7  
common infections c\ld become           
untreatable--ev5 fatal2 &  7,b7 m$ical  
advances su* z jo9t replacem5ts1        
,ces>ean sections1 organ transplants &  
*emo!rapy c\ld become nonviable4  7#aj7 
,antibiotic resi/ance1 result+ 9 a r$uc$
 numb] ( effective antibiotics1 may     
significantly impair ! ability ( !      
,unit$ ,/ates to respond to t]rori/     
attacks involv+ bact]ial infections1 su*
 z an?rax & smallpox1 or to an ev5t     
result+ 9 a l>ge influx ( hospitaliz$   
pati5ts4  7#aa7 ,9 #bjaa1 ! ,food &     
,drug ,adm9i/ration det]m9$ t-- 7,a7    
#ac4e million kilograms ( antibact]ial  
drugs 7 sold = use on food animals 9 !  
,unit$ ,/ates 9 #bjaj2  7,b7 #c4c       
million kilograms ( antibact]ial drugs 7
 us$ = human heal? 9 #bjaj2 &  7,c7     
!re=e1 #hj p]c5t ( antibact]ial drugs   
dissem9at$ 9 ! ,unit$ ,/ates 9 #bjaj 7  

sold = use on food animals1 r ?an be+   
us$ = human heal?4  7#ab7 ,! ,,fda      
,annual ,summ>y ,report on              
,antimicrobials ,sold or ,di/ribut$ 9   
#bjab = ,use 9 ,food-,produc+ ,animals  
%[$ t ! use ( m$ically important        
antibiotics 9 food-produc+ animals      
increas$ #af p]c5t f #bjji to #bjab4    
7#ac7  7,a7 ,9 #bjjc1 ! ,food & ,drug   
,adm9i/ration modifi$ ! drug approval   
process = antibiotics to recognize !    
developm5t ( resi/ant bact]ia z an      
important aspect ( safety1 b mo/        
antibiotics curr5tly us$ 9 animal       
production sy/ems = non!rapeutic        
purposes 7 approv$ be=e ! ,food & ,drug 
,adm9i/ration began consid]+ resi/ance  
dur+ ! drug-approval process4  7,b7 ,!  
,food & ,drug ,adm9i/ration has n       
e/abli%$ a s*$ule = review+ ^? exi/+    
approvals4  7#ad7 ,a /at$ goal ( ,,fda  
,guidance docum5ts #bji & #bac is a     
r$uction 9 ! ov]all consumption (       
antibiotics4 ,! ,,fda policy cont9ues to
 all[ ! use ( antibiotics = r\t9e       

disease prev5tion )\t requir+ evid5ce ( 
! pres5ce ( a specific disease or       
requir+ ! mitigation ( conditions :i*   
elevate disease risk4  7#ae7 ,!re is    
inadequate di/9ction betwe5 usage =     
disease prev5tion & production purposes1
 su* z gr[? promotion1 on ,,fda approv$ 
drug labels4 ,a #bjad analysis ( !      
approv$ animal drugs affect$ by         
,guidance #bac by ! ,pew ,*>itable      
,tru/s f\nd t num]\s approv$ drug labels
 conta9$ ov]lapp+ indications =         
gr[?-promotion & disease prev5tion4     
7#af7 ,! ,european ,union 7,,eu7 bann$ !
 use ( antibiotics = gr[? promotion 9   
#bjjf1 a full decade be=e ! ,,fda's     
volunt>y approa* w g into effect4  7#ag7
 ,s9ce ! ,,eu ban1 antibiotic usage has 
decreas$ )\t affect+ live/ock           
production4  7#ah7 ,9 #bjaj1 ! ,dani%   
,vet]9>y & ,food ,adm9i/ration te/ifi$ t
 ! ,dani% ban ( ! non!rapeutic use (    
antibiotics 9 food-animal production    
result$ 9 a m>k$ r$uction 9             
antimicrobial resi/ance 9 multiple      

bact]ial species1 includ+ ,campylobact] 
& ,ent]ococci4  7#ai7 ,! exp]i5ce 9 !   
,ne!rl&s has %[n t dur+ ! phase\t use   
indications = gr[? promotion 7          
completely supplant$ by disease         
prev5tion4 ,total antibiotic consumption
 rema9$ con/ant4 ,aft] ! implem5tation (
 m&atory r$uction t>gets & improv$      
surveillance ( usage practices          
antibiotic consumption decl9$ ahead (   
t>get )\t impact+ production levels4    
7#bj7 ,9 #bjji1 ! ,congressional ,rese>*
 ,s]vice conclud$ t )\t re/rictions on !
 use ( antimicrobial drugs 9 !          
production ( live/ock1 export m>kets =  
live/ock & p\ltry c\ld be negatively    
impact$ due to re/rictions on ! use (   
antibiotics 9 o!r nations4  7#ba7 ,!    
,am]ican ,m$ical ,association1 !        
,infecti\s ,disease ,society ( ,am]ica1 
! ,am]ican ,public ,heal? ,association1 
! ,national ,association ( ,c\nty &     
,city ,heal? ,(ficials1 & ! ,national   
,su/a9able ,agriculture ,coalition are  
among ! ov] #djj organizations repres5t+

 heal?1 consum]1 agricultural1          
environm5tal1 humane1 & o!r int]e/s t h 
support$ enactm5t ( legislation to      
phase\t non!rapeutic use 9 f>m animals (
 m$ically important antimicrobials4  #c4
 ,purpose ,! purpose ( ?is ,act is to   
pres]ve ! effectiv5ess ( m$ically       
important antimicrobials us$ 9 !        
treatm5t ( human & animal diseases4  #d4
 ,pro( ( safety ( m$ically important    
antimicrobials  7a7 ,applications p5d+  
or submitt$ aft] enactm5t ,section      
#eab7;d77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;b7d77#a77 is am5d$-- 7#a7 9 ! fir/ 
s5t5ce--  7,a7 9 subp>agraph 7,h71 by   
/rik+ or at ! end2  7,b7 9 subp>agraph  
7,i71 by ins]t+ or at ! end2 &  7,c7 by 
ins]t+ aft] subp>agraph 7,i7 ! foll[+3  
7,j7 ) respect to a m$ically important  
antimicrobial 7z def9$ 9 subsection     
7q771 ! applicant has fail$ to          
demon/rate t !re is a reasonable c]ta9ty
 ( no h>m to human heal? due to !       
developm5t ( antimicrobial resi/ance t  

is attributable1 9 :ole or 9 "p1 to !   
non!rapeutic use 7z def9$ 9 subsection  
7q77 ( ! m$ically important             
antimicrobial or drug2  2 &  7#b7 9 !   
second s5t5ce1 by /rik+ 7,a7 ?r\gh 7,i7 
& ins]t+ 7,a7 ?r\gh 7,j74  7b7 ,phas$   
elim9ation ( non!rapeutic use 9 animals 
( m$ically important antimicrobials     
,section #eab ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7  
is am5d$ by add+ at ! end ! foll[+3  7q7
 ,phas$ elim9ation ( non!rapeutic use 9 
animals ( m$ically important            
antimicrobials  7#a7 ,applicability ,?is
 p>agraph applies to ! non!rapeutic use 
9 a food-produc+ animal ( a drug-- 7,a7 
t is a m$ically important antimicrobial2
 or  7,b7  7i7 = :i* !re is 9 effect an 
approval ( an application or an         
exemption "u subsection 7b71 7i71 or 7j7
 ( section #eje2 or  7ii7 t is o!rwise  
m>ket$ = human use4  7#b7 ,)drawal ,!   
,secret>y %all )draw ! approval ( a     
non!rapeutic use 9 food-produc+ animals 
( a drug describ$ 9 p>agraph 7#a7 on !  

date t is #b ye>s aft] ! date ( enactm5t
 ( ?is subsection unless--  7,a7 be=e ! 
date t is #b ye>s aft] ! date ( !       
enactm5t ( ?is subsection1 ! ,secret>y  
makes a f9al writt5 det]m9ation t !     
hold] ( ! approv$ application has       
demon/rat$ t !re is a reasonable c]ta9ty
 ( no h>m to human heal? due to !       
developm5t ( antimicrobial resi/ance t  
is attributable 9 :ole or 9 "p to !     
non!rapeutic use ( ! drug2 or  7,b7 be=e
 ! date specifi$ 9 subp>agraph 7,a71 !  
,secret>y makes a f9al writt5           
det]m9ation "u ?is subsection1 ) respect
 to a risk analysis ( ! drug conduct$ by
 ! ,secret>y & o!r relevant in=mation1 t
 !re is a reasonable c]ta9ty ( no h>m to
 human heal? due to ! developm5t (      
antimicrobial resi/ance t is            
attributable 9 :ole or 9 "p to !        
non!rapeutic use ( ! drug4  7#c7        
,exemptions ,except z provid$ 9 p>agraph
 7#e71 if ! ,secret>y grants an         
exemption "u section #eje7;i7 = a drug t
 is a m$ically important antimicrobial1 

! ,secret>y %all resc9d ea* approval ( a
 non!rapeutic use 9 a food-produc+      
animal ( ! m$ically important           
antimicrobial z ( ! date t is #b ye>s   
aft] ! date on :i* ! ,secret>y grants ! 
exemption4  7#d7 ,approvals ,except z   
provid$ 9 p>agraph 7#e71 if an          
application = a drug t is a m$ically    
important antimicrobial is submitt$ to !
 ,secret>y "u section #eje7;b71 !       
,secret>y %all resc9d ea* approval ( a  
non!rapeutic use 9 a food-produc+ animal
 ( ! m$ically important antimicrobial z 
( ! date t is #b ye>s aft] ! date on :i*
 ! application is submitt$ to !         
,secret>y4  7#e7 ,exceptions ,p>agraph  
7#c7 or 7#d71 z ! case may be1 %all n   
apply if-- 7,a7 be=e ! date on :i*      
approval w\ld be resc9d$ "u t p>agraph1 
! ,secret>y makes a f9al writt5         
det]m9ation t ! hold] ( ! application = 
! approv$ non!rapeutic use has          
demon/rat$ t !re is a reasonable c]ta9ty
 ( no h>m to human heal? due to !       
developm5t ( antimicrobial resi/ance t  

is attributable 9 :ole or 9 "p to !     
non!rapeutic use 9 ! food-produc+ animal
 ( ! m$ically important antimicrobial2  
or  7,b7 be=e ! date specifi$ 9         
subp>agraph 7,a71 ! ,secret>y makes a   
f9al writt5 det]m9ation1 ) respect to a 
risk analysis ( ! m$ically important    
antimicrobial conduct$ by ! ,secret>y & 
any o!r relevant in=mation1 t !re is a  
reasonable c]ta9ty ( no h>m to human    
heal? due to ! developm5t (             
antimicrobial resi/ance t is            
attributable 9 :ole or 9 "p to !        
non!rapeutic use ( ! m$ically important 
antimicrobial4  7#f7 ,def9ition ,9 ?is  
subsection3 7,a7 ,! t]m m$ically        
important antimicrobial means a drug t--
  7i7 is int5d$ = use 9 food-produc+    
animals2 &  7ii7 is compos$ :olly or    
p>tly (--  7,i7 any k9d ( p5icill91     
tetracycl9e1 macrolide1 l9cosamide1     
/reptogram91 am9oglycoside1 sulfonamide1
 or cephalospor92 or  7,,ii7 a drug f an
 antimicrobial class t is li/$ z highly 
important1 critically important1 or     

important by ! ,_w ,heal? ,organization 
9 ! late/ edition ( its publication     
entitl$ ,critically ,important          
,antimicrobials = ,human ,m$ic9e 7or a  
successor publication74  7,b7 ,! t]m    
!rapeutic use1 ) respect to a m$ically  
important antimicrobial1 means ! use (  
antimicrobials = ! specific purpose (   
treat+ an animal ) a docum5t$ disease or
 infection4 ,su* t]m does n include !   
cont9u$ use ( su* an antimicrobial 9 !  
animal aft] ! disease or infection is   
resolv$4  7,c7 ,! t]m non!rapeutic use--
 7i7 means adm9i/ration ( antibiotics to
 an animal ?r\gh fe$ & wat] 7or1 9      
p\ltry hat*]ies1 ?r\gh any means7 =     
purposes 7su* z gr[? promotion1 fe$     
effici5cy1 weight ga91 or disease       
prev5tion7 o!r ?an !rapeutic use or     
nonr\t9e disease control2 &  7ii7       
includes any repeat$ or regul> patt]n ( 
use ( m$ically important antimicrobials 
= purposes o!r ?an !rapeutic use or     
nonr\t9e disease control4  7,d7 ,! t]m  
noncu/om>y situation does n include     

normal or /&>d practice & conditions on 
! premises t facilitate ! transmission (
 disease4  7,e7 ,! t]m nonr\t9e disease 
control means ! use ( antibiotics on an 
animal t is n sick b :]e x c be %[n t a 
p>ticul> disease or infection is pres5t1
 or is likely to occur because ( a      
specific1 noncu/om>y situation1 on !    
premises at ! b>n1 h\se1 p51 or o!r     
level at :i* ! animal is kept4  4  #e4  
,limitations on use ( m$ically important
 antimicrobials = nonr\t9e disease      
control  7a7 ,prohibit$ acts ,section   
#cja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is  
am5d$ by add+ at ! end ! foll[+3  7ccc7 
,! adm9i/ration ( a m$ically important  
antimicrobial to a food-produc+ animal =
 nonr\t9e disease control 9 violation ( 
! requirem5ts ( section #eab;,a4  4  7b7
 ,requirem5ts ,*apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by ins]t+ aft] section #eab ( su* ,act  
7#ba ,u4,s4,c4 #cfj;b7 ! foll[+3        
#eab;,a4 ,limitations on use ( m$ically 

important antimicrobials = nonr\t9e     
disease control  7a7 ,prohibition ,x    
%all be unlawful to adm9i/] 7includ+ by 
means ( animal fe$7 a m$ically important
 antimicrobial to a food-produc+ animal 
= nonr\t9e disease control unless--     
7#a7 !re is a significant risk t a      
disease or infection pres5t on !        
premises w be transmitt$ to !           
food-produc+ animal2  7#b7 !            
adm9i/ration ( ! m$ically important     
antimicrobial to ! food-produc+ animal  
is necess>y to prev5t or r$uce ! risk ( 
transmission ( ! disease or infection   
describ$ 9 p>agraph 7#a72  7#c7 !       
m$ically important antimicrobial is     
adm9i/]$ to ! food-produc+ animal =     
nonr\t9e disease control = ! %orte/     
duration possible to prev5t or r$uce !  
risk ( transmission ( ! disease or      
infection describ$ 9 p>agraph 7#a7 to ! 
animal2 &  7#d7 ! m$ically important    
antimicrobial is adm9i/]$-- 7,a7 at a   
scale no great] ?an ! b>n1 h\se1 or p5  
level2 &  7,b7 to ! fewe/ animals       

possible to prev5t or r$uce ! risk (    
transmission ( ! disease or infection   
describ$ 9 p>agraph 7#a74  7b7          
,def9itions ,9 ?is section3 7#a7 ,! t]m 
food-produc+ animal means a food-produc+
 animal int5d$ = sale 9 int]/ate        
comm]ce4  7#b7 ,! t]ms m$ically         
important antimicrobial & nonr\t9e      
disease control h ! mean+s giv5 to su*  
t]ms 9 section #eab7q74  4  7c7         
,applicability ,! am5dm5ts made by ?is  
section apply beg9n+ on ! date t is #f  
mon?s aft] ! date ( ! enactm5t ( ?is    
,act4