,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #ecej  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #ca1 #bjad ,mr4 
,latta 7= himself & ,mr4 ,murphy (      
,p5nsylvania7 introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce1 & 9 addition to ! ,committee 
on ,agriculture1 = a p]iod to be        
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to am5d ! ,f$]al   
,insecticide1 ,fungicide1 & ,rod5ticide 
,act to all[ ! m>ket+1 di/ribution1 or  
sale ( solid antimicrobial copp] alloys 
) c]ta9 claims1 to am5d ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act to exclude c]ta9
 solid antimicrobial copp] alloys f     
regulation z drugs or devices1 & = o!r  
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,infection ,r$uction       
,label+ ,act ( #bjad4  #b4 ,treatm5t (  
solid antimicrobial copp] alloys "u     
,f$]al ,insecticide1 ,fungicide1 &      
,rod5ticide ,act ,section #c ( ! ,f$]al 

,insecticide1 ,fungicide1 & ,rod5ticide 
,act 7#g ,u4,s4,c4 #acf;a7 is am5d$ by  
add+ at ! end ! foll[+ new subsection3  
7i7 ,claims made = solid antimicrobial  
copp] alloys  7#a7 ,c]ta9 claims        
au?oriz$ ,not)/&+ any o!r provision (   
?is ,act1 solid antimicrobial copp]     
alloys1 & products made f su* alloys1   
may be m>ket$1 di/ribut$1 or sold )     
label+ mak+ claims reg>d+ ! microbial   
r$uction or infection control efficacy (
 ! alloys if ! claims are consi/5t ) !  
results (--  7,a7 f$]ally-fund$ cl9ical 
trials f9d+ great] ?an #be p]c5t        
r$uctions 9 infection rate or #ej p]c5t 
r$uctions 9 microbial burd52 or  7,b7   
f$]ally-fund$ cl9ical trials f9d+       
/ati/ically significant r$uctions 9     
infection rate or microbial burd54  7#b7
 ,submission or review ( efficacy data  
waiv$ ,! regi/ration ( solid            
antimicrobial copp] alloys "u ?is       
section %all n require submission or    
review ( efficacy data relat$ to claims 
consi/5t ) ! results ( ! cl9ical trials 

describ$ 9 p>agraph 7#a74  7#c7         
,consi/5cy ( claims ) ag5cy-regi/]$     
product label  7,a7 ,9 g5]al ,claims    
describ$ 9 p>agraph 7#a7 %all be        
consi/5t ) ! product label regi/]$ "u   
?is section4  7,b7 ,process =           
modification ( label+ ,9 lieu ( !       
notification process "u subsection      
7c77#i71 regi/ration ( a solid          
antimicrobial copp] alloy may be modifi$
 to ensure ! consi/5cy ( claims describ$
 9 p>agraph 7#a7 ) ! product label+     
pursuant to ! foll[+ process3  7i7 ,!   
regi/rant %all submit a notification    
id5tify+ ! propos$ claims t are consi/5t
 ) ! results ( ! cl9ical trials describ$
 9 p>agraph 7#a71 & include a copy ( !  
propos$ am5d$ product label4  7ii7 ,)9  
#cj days aft] receipt ( su* a           
notification1 ! ,adm9i/rator %all--     
7,i7 notify ! regi/rant 9 writ+ if !    
,adm9i/rator objects to any ( ! propos$ 
claims z n consi/5t ) ! results ( !     
cl9ical trials describ$ 9 p>agraph 7#a72
 &  7,,ii7 /ate ! reasons :y4  7iii7 ,a 

regi/rant may file a response to any su*
 objection n lat] ?an #cj days aft] !   
regi/rant's receipt ( ! objection4  7iv7
 ,aft] receipt & consid]ation ( any su* 
response1 ! ,adm9i/rator %all issue a   
decision )9 #cj days4  7v7 ,a decision  
"u clause 7iv7 %all be consid]$ to be a 
f9al ag5cy action4  7vi7 ,a regi/rant   
may di/ribute or sell a solid           
antimicrobial copp] alloy product ) !   
claims describ$ 9 p>agraph 7#a7 aft] #fj
 days ( submission ( ! notification     
describ$ 9 ?is subp>agraph1 unless !    
,adm9i/rator issues an objection z      
describ$ 9 ?is subp>agraph4  7#d7       
,def9ition ,9 ?is subsection1 ! t]m     
solid antimicrobial copp] alloy means a 
solid copp] alloy t--  7,a7 is regi/]$  
"u ?is section2  7,b7 is li/$ "u        
,environm5tal ,protection ,ag5cy        
regi/ration numb] #hbjab-a1 #hbjab-b1   
#hbjab-c1 #hbjab-d1 #hbjab-e1 or        
#hbjab-f1 or is o!rwise id5tifi$ by a   
,unifi$ ,numb]+ ,sy/em code 9 an        
,environm5tal ,protection ,ag5cy        

regi/ration2  7,c7 has a copp] cont5t ( 
n less ?an #fj weight p]c5t2 &  7,d7 has
 a cont5t ( n m ?an #j4a weight p]c5t ( 
ea* ( ! foll[+3 lead1 *romium1 & ars5ic4
  4  #c4 ,treatm5t ( solid antimicrobial
 copp] alloys "u ,f$]al ,food1 ,drug1 & 
,cosmetic ,act ,sub*apt] ,e ( *apt] ,v (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 is am5d$ by ins]t+ aft] section #efi;,c
 ( su* ,act 7#ba ,u4,s4,c4              
#cfj;bbb-#h;c7 ! foll[+3  #efi;,d4      
,solid antimicrobial copp] alloys  7a7  
,exclusion f treatm5t z drug or device  
,a product t is made f solid            
antimicrobial copp] alloy & has label+  
mak+ a claim reg>d+ ! microbial r$uction
 or infection control efficacy ( !      
alloy1 consi/5t ) ! results (           
f$]ally-fund$ cl9ical trials1 %all n1 by
 virtue ( su* claim--  7#a7 be treat$ z 
a drug or device1 or z a comb9ation     
!re(1 = purposes ( ?is ,act2 or  7#b7   
o!rwise be subject to regulation by !   
,food & ,drug ,adm9i/ration4  7b7       
,def9ition ,9 ?is section1 ! t]m solid  

antimicrobial copp] alloy means a solid 
copp] alloy t--  7#a7 is li/$ "u        
,environm5tal ,protection ,ag5cy        
regi/ration numb] #hbjab-a1 #hbjab-b1   
#hbjab-c1 #hbjab-d1 #hbjab-e1 or        
#hbjab-f1 or is o!rwise id5tifi$ by a   
,unifi$ ,numb]+ ,sy/em code 9 an        
,environm5tal ,protection ,ag5cy        
regi/ration2  7#b7 has a copp] cont5t ( 
n less ?an #fj weight p]c5t2 &  7#c7 has
 a cont5t ( n m ?an #j4a weight p]c5t ( 
ea* ( ! foll[+3 lead1 *romium1 & ars5ic4
  4