,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #cfii  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #d1 #bjba,ms4   
,de,lauro introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to direct !       
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 to update & cl>ify its rule on  
sub/ances g5]ally recogniz$ z safe1 & = 
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,toxic ,free ,food ,act
 ( #bjba4  #b4 ,direct$ rulemak+ reg>d+ 
sub/ances g5]ally recogniz$ z safe  7a7 
,direct$ rulemak+  7#a7 ,9 g5]al ,!     
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all-- 7,a7 n lat] ?an #ahj days
 aft] ! date ( enactm5t ( ?is ,act1     
publi% a propos$ revision to ! f9al rule
 titl$ ,sub/ances ,g5]ally ,recogniz$ z 
,safe1 publi%$ by ! ,food & ,drug       
,adm9i/ration on ,augu/ #ag1 #bjaf 7#ha 
,f$]al ,regi/] #edifj et seq472 &  7,b7 
n lat] ?an #ij days aft] ! close ( !    

p]iod = public comm5t on ! revision     
propos$ pursuant to subp>agraph 7,a71   
publi% a f9al revision to su* f9al rule4
  7#b7 ,cont5ts ,! revision requir$ by  
p>agraph 7#a7 %all include ea* ( !      
foll[+3 7,a7 ,! revision %all prohibit a
 manufactur] f m>ket+ a sub/ance z      
,,gras1 or manufactur+ or sell+ food t  
conta9s a sub/ance ! manufactur] has    
det]m9$ to be ,,gras1 unless-- 7i7 !    
,secret>y has receiv$ notice t !        
manufactur] has det]m9$ su* sub/ance to 
be ,,gras2 &  7ii7 ! manufactur] has    
provid$ ! ,secret>y ) support+ in=mation
 suffici5t to und]/& ! basis ( !        
det]m9ation1 includ+1 z requir$ by !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cja et seq47-- 7,i7 !   
cumulative effects ( ! sub/ance1 z      
requir$ "u section #dji ( su* ,act 7#ba 
,u4,s4,c4 #cdh72  7,,ii7 an adequately  
protective use ( safety factors2 &      
7,,iii7 application ( a m>g9 ( safety to
 take into acc\nt ! impacts ( exposures 
dur+ critical w9d[s ( developm5t & on   

vuln]able populations4  7,b7 ,! revision
 %all require ! ,secret>y-- 7i7 to make 
ea* det]m9ation t is submitt$ pursuant  
to subp>agraph 7,a77i71 & ! support+    
in=mation submitt$ pursuant to          
subp>agraph 7,a77ii71 publicly available
 on ! website ( ! ,food & ,drug         
,adm9i/ration2 &  7ii7 provide a p]iod (
 at lea/ #ij days = ! ,secret>y & !     
public to review ea* su* det]m9ation &  
object1 if appropriate1 9 ord] to ensure
 t ! sub/ance involv$ is safe tak+ into 
acc\nt ! factors 9 li/$ 9 section       
#dji7;c77#e7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cdh7;c77#e774  7,c7 ,! revision %all   
cl>ify t newly syn!siz$ or novel *emical
 sub/ances _c be ,,gras4  7,d7 ,!       
revision %all cl>ify t c>c9og5ic        
sub/ances _c be ,,gras4  7,e7 ,!        
revision %all-- 7i7 prohibit ! ,secret>y
 f rely+ on ! det]m9ation ( exp]ts )    
conflicts ( int]e/ :5 det]m9+ a sub/ance
 to be ,,gras2 &  7ii7 incorporate !    
recomm5dations 9 ! draft guidance titl$ 

,be/ ,practices = ,conv5+ a ,,gras      
,panel1 issu$ by ! ,food & ,drug        
,adm9i/ration 9 ,novemb]1 #bjag1 &      
measures to /r5g!n ! recomm5dations 9   
su* guidance4  7,f7 ,! revision %all    
create a process t requires ! ,secret>y 
to sy/ematically reassess any sub/ance t
 0 det]m9$ to be ,,gras if su*          
det]m9ation did n meet ! revis$ /&>ds = 
su* a det]m9ation4  7b7 ,food ,advisory 
,committee ,n lat] ?an #ahj days aft] ! 
date ( enactm5t ( ?is ,act1 ! ,secret>y 
%all-- 7#a7 ree/abli% ! ,food ,advisory 
,committee to "w ) ! ,secret>y on !     
reassessm5t /&>ds1 process1 & me?ods    
necess>y to complete ! "w describ$ 9    
subsection 7a77#b77;,f72 &  7#b7 provide
 su* ,committee ) su* /aff+ & res\rces z
 are necess>y to complete su* "w4  7c7  
,def9itions ,9 ?is subsection3 7#a7 ,!  
t]m ,,gras means1 ) respect to a        
sub/ance1 g5]ally recogniz$1 among      
exp]ts qualifi$ by sci5tific tra9+ &    
exp]i5ce to evaluate its safety1 z hav+ 
be5 adequately %[n ?r\gh sci5tific      

proc$ures 7or1 9 ! case ( a sub/ance us$
 9 food prior to ,janu>y #a1 #aieh1     
?r\gh ei!r sci5tific proc$ures or       
exp]i5ce bas$ on common use 9 food7 to  
be safe "u ! conditions ( its int5d$    
use1 z describ$ 9 section #bja7s7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba74  7#b7 ,! t]m      
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices4