,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #dieh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,augu/ #ab1 #bjbe ,mr4
 ,pallone introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
require notification to ! ,food & ,drug 
,adm9i/ration prior to use ( sub/ances z
 g5]ally recogniz$ z safe1 reassessm5t (
 ! safety ( c]ta9 sub/ances m>ket$ z    
g5]ally recogniz$ z safe1 provide       
res\rces = reviews & reassessm5ts1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,groc]y ,re=m ,&       
,safety ,act or ! ,,gras ,act4  #b4     
,removal ( ,,gras exemption f food      
additive def9ition  7a7 ,9 g5]al        
,section #bja7s7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7s77 is am5d$--  7#a7 by r$esignat+ 
subp>agraphs 7#a7 ?r\gh 7#f7 z clauses  
7,a7 ?r\gh 7,g71 respectively2  7#b7 by 
/rik+ ,! t]m food additive & ins]t+ 7#a7
 ,! t]m food additive2  7#c7 by /rik+ 1 

if su* sub/ance is & all t foll[s ?r\gh 
( its int5d$ use2 & ins]t+ 1 includ+ a  
sub/ance t is g5]ally recogniz$ z safe12
 &  7#d7 by add+ at ! end ! foll[+3     
7#b7 ,! t]m g5]ally recogniz$ z safe    
means1 ) respect to a sub/ance us$ 9    
food z describ$ 9 subp>agraph 7#a71 t   
su* sub/ance is 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$    
use4  4  7b7 ,con=m+ am5dm5t ,section   
#djh7k77#b7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cdf;a7k77#b77 is am5d$ by /rik+ section
 #bja7s77#d7 & ins]t+ section           
#bja7s77#a77;,d74  #c4 ,,gras           
notifications ,section #dji ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cdh7 is am5d$-- 7#a7 9       

subsection 7a7--  7,a7 9 p>agraph 7#b71 
by /rik+ ! or at ! end2  7,b7 9 p>agraph
 7#c71 by /rik+ ! p]iod at ! end &      
ins]t+ 2 or2 &  7,c7 by add+ at ! end ! 
foll[+3  7#d7 ! food additive is g5]ally
 recogniz$ z safe1 & ! proc$ural        
requirem5ts ( subsection 7l7 h be5 met )
 respect to ! food additive4  2 &  7#b7 
by add+ at ! end ! foll[+3  7l7 ,notices
 reg>d+ use ( ,,gras sub/ances  7#a7 ,9 
g5]al ,any p]son t manufactures1        
introduces1 deliv]s = introduction1 or  
receives a food sub/ance 9 int]/ate     
comm]ce t is int5d+ to treat su* food   
sub/ance z g5]ally recogniz$ z safe 79  
?is subsection ref]r$ to z ,,gras7 %all1
 ) respect to any new use ( su* sub/ance
 or use ( a food sub/ance t 0 n m>ket$ =
 use 9 foods 9 ! ,unit$ ,/ates be=e !   
date ( enactm5t ( ?is subsection1 submit
 to ! ,secret>y a notice prescrib+ !    
conditions "u :i* su* p]son det]m9$ su* 
sub/ance is ,,gras4  7#b7 ,requir$      
in=mation ,a notice submitt$ "u p>agraph
 7#a7 ) respect to a food sub/ance %all 

include publicly available support+ data
 & in=mation suffici5t to demon/rate !  
id5tity & composition1 ! manufactur+    
process1 ! int5d$ effect1 & ! safety ( !
 food sub/ance1 us$ z ! basis ( ! ,,gras
 det]m9ation1 includ+ full reports (    
inve/igations made ) respect to ! safety
 = use ( su* sub/ance1 includ+-- 7,a7   
in=mation z to ! me?ods & controls us$ 9
 conduct+ su* inve/igations2  7,b7      
in=mation on ! cumulative effects ( su* 
sub/ance2  7,c7 in=mation on haz>d1 dose
 response1 & exposure2  7,d7 in=mation  
on ! application ( adequately protective
 safety factors to ensure an appropriate
 m>g9 ( safety to take into acc\nt      
unc]ta9ties 9 haz>d id5tification1 dose 
response1 exposure1 & s5sitivities2     
7,e7 in=mation demon/rat+ ! analysis t !
 weight ( ! evid5ce %[s t su* sub/ance  
has n be5 f\nd to be c>c9og5ic2  7,f7   
in=mation demon/rat+ ! analysis t !     
weight ( ! evid5ce %[s t su* sub/ance   
has n be5 f\nd to induce reproductive   
toxicity or developm5tal toxicity 9     

humans or animals1 includ+ ?r\gh an     
endocr9e mode ( action2 &  7,g7 su* o!r 
in=mation t =ms ! recognition ( safety z
 ! ,secret>y may publicly specify4  7#c7
 ,=m ( notice ,a notice submitt$ "u     
p>agraph 7#a7 ) respect to a food       
sub/ance %all be submitt$ 9 su* =m &    
mann] z specifi$ 9 subp>t ,e ( "p #agj (
 title #ba1 ,code ( ,f$]al ,regulations 
7or successor regulations74  7#d7       
,/atem5t n to object to use ,a p]son may
 use a sub/ance subject to a notice "u  
p>agraph 7#a7 only if ! ,secret>y has   
issu$ a writt5 /atem5t to n object to ! 
det]m9ation t ! sub/ance is ,,gras "u ! 
conditions prescrib$ 9 ! notice4  7#e7  
,/atem5t to object ,! ,secret>y %all    
issue a writt5 /atem5t object+ to use ( 
a sub/ance subject to a notice "u       
p>agraph 7#a7 if ! ,secret>y det]m9es   
t-- 7,a7 ! notice does n conta9 !       
support+ data & in=mation describ$ 9    
p>agraph 7#b72  7,b7 ) respect to any   
su* support+ data & in=mation t 0       
provid$ by an exp]t1 su* exp]t appe>s to

 h a conflict ( int]e/1 z det]m9$       
pursuant to guidance issu$ by !         
,secret>y2 or  7,c7 su* support+ data & 
in=mation does n adequately support a   
det]m9ation t ! sub/ance is ,,gras "u ! 
conditions prescrib$ 9 ! notice4  7#f7  
,det]m9ation timel9e  7,a7 ,9 g5]al ,!  
,secret>y %all-- 7i7 n lat] ?an #ahj    
days aft] ! acceptance ( a notice "u    
p>agraph 7#a71 issue a writt5 /atem5t "u
 p>agraph 7#d7 or 7#e72 or  7ii7 provide
 writt5 notice to ext5d ! #ahj-;day     
p]iod describ$ 9 subp>agraph 7,a7 = "o  
additional #ij-;day p]iod1 z specifi$ 9 
regulations4  7,b7 ,corrections ,!      
timel9e set =? 9 subp>agraph 7,a7 %all n
 be con/ru$ to limit ! au?ority ( !     
,secret>y to correct a /atem5t ( !      
,secret>y to n object to ! det]m9ation t
 ! sub/ance is ,,gras if new evid5ce is 
subsequ5tly pres5t$ or discov]$4  7#g7  
,public availability & comm5t ,!        
,secret>y %all-- 7,a7 ^u acceptance ( a 
notice "u p>agraph 7#a7--  7i7 make su* 
notice1 & ! support+ data & in=mation   

describ$ 9 p>agraph 7#b71 publicly      
available 9 a s+le location on ! website
 ( ! ,food & ,drug ,adm9i/ration2 &     
7ii7 provide an opportunity = public    
comm5t = a p]iod ( n less ?an #fj days2 
&  7,b7 ^u close ( ! comm5t p]iod1 make 
any writt5 /atem5t issu$ "u p>agraph    
7#d7 or 7#e7 publicly available 9 ! same
 location4  7#h7 ,au?orization (        
appropriations ,!re is au?oriz$ to be   
appropriat$ su* sums z may be necess>y  
to c>ry out ?is subsection4  4  #d4     
,reassessm5ts ,section #dji ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cdh71 z am5d$ by section #c1 
is fur!r am5d$ by add+ at ! end !       
foll[+3  7m7 ,reassessm5ts  7#a7 ,9     
g5]al ,n lat] ?an #c ye>s aft] ! date ( 
enactm5t ( ?is subsection1 & at lea/ e  
#c ye>s !reaft]1 ! ,secret>y %all       
sy/ematically reassess ! safety 7includ+
 ! safety ( conditions ( use71 )9 !     
mean+ ( section #dji1 ( at lea/ #aj ( ! 
foll[+ sub/ances 7or classes !re(73     
7,a7 ,food additives m>ket$ pursuant to 

an ord] "u subsection 7c74  7,b7 ,any   
sub/ance :i* 01 be=e ! date ( ! enactm5t
 ( ?is subsection1 consid]$ g5]ally     
recogniz$ z safe4  7,c7 ,color          
additives4  7,d7 ,prior-sanction$       
sub/ances 7z describ$ 9 subp>agraph 7,d7
 ( section #bja7s77#a774  7,e7 ,food    
contact sub/ances4  7#b7 ,safety        
evaluations ,9 conduct+ ! reassessm5ts  
"u ?is subsection1 ! ,secret>y may      
require any p]son t manufactures1       
introduces1 deliv]s = introduction1 or  
receives a food sub/ance describ$ 9     
p>agraph 7#a7 9 int]/ate comm]ce to     
conduct1 & submit to ! ,secret>y1 safety
 evaluations ( su* sub/ance4 ,su* a     
safety evaluation %all include1 )       
respect to su* sub/ance1 updat$         
in=mation on--  7,a7 e/imates ( diet>y  
exposure among ! ,unit$ ,/ates          
population2  7,b7 ! cumulative effects (
 su* sub/ance2  7,c7 haz>d1 dose        
response1 & exposure2  7,d7 !           
application ( adequately protective     
safety factors to ensure an appropriate 

m>g9 ( safety to take into acc\nt       
unc]ta9ties 9 haz>d id5tification1 dose 
response1 exposure1 & s5sitivities2     
7,e7 :e!r ! weight ( ! evid5ce %[s t su*
 sub/ance has n be5 f\nd to be          
c>c9og5ic2  7,f7 :e!r ! weight ( !      
evid5ce %[s t su* sub/ance has n be5    
f\nd to induce reproductive toxicity or 
developm5tal toxicity 9 humans or       
animals1 includ+ ?r\gh an endocr9e mode 
( action2 &  7,g7 su* o!r in=mation z ! 
,secret>y may specify 9 regulation4     
7#c7 ,revok+ /atem5t to n object ,if !  
,secret>y det]m9es1 ) respect to a      
sub/ance describ$ 9 p>agraph 7#a77;,b71 
bas$ on in=mation receiv$ "u p>agraph   
7#b7 & publicly available in=mation1 t a
 conc]n ab\t ! safety ( ! sub/ance1 or !
 int5d$ use ( ! sub/ance1 exi/s1 !      
,secret>y--  7,a7 may revoke a writt5   
/atem5t previ\sly issu$ by ! ,secret>y  
to n object to a det]m9ation t !        
sub/ance is g5]ally recogniz$ z safe2 & 
7,b7 %all po/ su* revocation 9 !        
location on ! website ( ! ,food & ,drug 

,adm9i/ration ref]r$ to 9 subsection    
7l77#g74  7#d7 ,notices ( sub/ances     
m>ket$ z ,,gras ,! ,secret>y may require
 a p]son t manufactures1 introduces1    
deliv]s = introduction1 or receives a   
food sub/ance describ$ 9 p>agraph 7#a7 9
 int]/ate comm]ce t 0 m>ket$ z g5]ally  
recogniz$ z safe be=e1 on1 & aft] ! date
 ( enactm5t ( ?is subsection to submit  
to ! ,secret>y a notification t su*     
p]son s m>ket$ ! sub/ance z g5]ally     
recogniz$ z safe4  7#e7 ,civil monet>y  
p5alties ,9 ! case ( a violation ( ?is  
subsection1 ! ,secret>y %all assess a   
civil p5alty 9 accordance ) section     
#cjg4  7#f7 ,au?orization (             
appropriations ,!re is au?oriz$ to be   
appropriat$ su* sums z may be necess>y  
to c>ry out ?is subsection4  4  #e4     
,def9itions  7a7 ,9 g5]al ,section #dji 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cdh71 z am5d$ by   
sections #c & #d1 is fur!r am5d$ by add+
 at ! end ! foll[+3  7n7 ,def9itions ,9 
?is section3 7#a7 ,c>c9og5ic ,! t]m     

c>c9og5ic means1 ) respect to a         
sub/ance1 t su* sub/ance has be5 f\nd-- 
7,a7 to induce canc] :5 +e/$ by humans  
or animals2 or  7,b7 aft] evaluation    
?r\gh appropriate te/+ me?ods1 by rese>*
 or assessm5t conduct$ by an            
au?oritative sci5tific body 7su* z !    
,environm5tal ,protection ,ag5cy1 !     
,int]national ,ag5cy = ,rese>* on       
,canc]1 or ! ,national ,toxicology      
,program71 to induce canc] 9 humans or  
animals4  7#b7 ,class ,! t]m class1 )   
respect to a sub/ance1 means a gr\p (   
*emicals t are *emically simil> or cause
 simil> or relat$ ph>macological        
effects4  7#c7 ,conflict ( int]e/ ,! t]m
 conflict ( int]e/ means a p]sonal or   
f9ancial int]e/ t c\ld pot5tially       
compromise ! pr(essional judgm5t or     
objectivity ( an individual 9 design+1  
conduct+1 report+1 or review+ rese>* or 
! applicability ( rese>*1 pot5tially    
und]m9+ ! integrity ( su* rese>*4  7#d7 
,cumulative effects ,! t]m cumulative   
effects means1 ) respect to a sub/ance1 

! comb9$ heal? effects ( all *emically  
or ph>macologically-relat$ sub/ances4   
7#e7 ,developm5tal toxicity ,! t]m      
developm5tal toxicity means1 ) respect  
to ! effect ( exposure to a sub/ance on 
a human or animal1 an adv]se effect on !
 developm5t ( su* human or animal t     
results f su* exposure--  7,a7 to ! "m  
prior to conception (1 or dur+ ! pr5atal
 p]iod =1 su* human or animal2 or  7,b7 
to su* human or animal be=e ! "t (      
sexual maturity4  7#f7 ,food contact    
sub/ance ,! t]m food contact sub/ance   
means any sub/ance int5d$ = use z a     
compon5t ( mat]ials us$ 9 manufactur+1  
pack+1 packag+1 transport+1 or hold+    
food if su* use is n int5d$ to h any    
te*nical effect 9 su* food4  7#g7 ,new  
use ,! t]m new use means a use o!r ?an--
  7,a7 a use ( a sub/ance g5]ally       
recogniz$ z safe be=e1 on1 & aft] ! date
 ( enactm5t ( ?is subsection2  7,b7 a   
use ( a sub/ance treat$ z g5]ally       
recogniz$ z safe "u subsection 7l72 or  
7,c7 a use ( a prior-sanction$ sub/ance 

7z describ$ 9 subp>agraph 7,d7 ( section
 #bja7s77#a774  7#h7 ,reproductive      
toxicity ,! t]m reproductive toxicity   
means1 ) respect to ! effect ( exposure 
to a sub/ance on a human or animal1 an  
adv]se effect on ! reproductive sy/em ( 
su* human or animal1 :i* may include    
alt]ations to reproductive sy/em        
developm5t1 ! endocr9e sy/em1 f]tility1 
pregnancy1 pregnancy outcomes1 or       
modifications 9 o!r functions t are     
dep5d5t on ! integrity ( ! reproductive 
sy/em4  4  7b7 ,con=m+ am5dm5ts  7#a7   
,section #bja7q77#a77;,b77ii7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cba7q77#a77;,b77ii77 is am5d$
 by /rik+ section #dji7;h77#f7 & ins]t+ 
section #dji7n74  7#b7 ,section #dji7;h7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cdh7;h77 is am5d$  
by /rik+ p>agraph 7#f74  #f4 ,food      
additive & ,,gras sub/ance fees ,section
 #gdc ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgi;j-#ca7 is am5d$-- 7#a7 9 subsection

 7a77#a7--  7,a7 9 subp>agraph 7,c71 by 
/rik+ & at ! end2  7,b7 9 subp>agraph   
7,d71 by /rik+ ! p]iod at ! end & ins]t+
 a semicolon2 &  7,c7 by add+ at ! end !
 foll[+3  7,e7 ea* p]son fil+ a petition
 or submitt+ a notice ) respect to a    
food additive1 = purposes ( issu+       
regulations or review+ notices "u       
section #dji prescrib+ ! conditions "u  
:i* su* food additive may be safely us$2
 &  7,f7 ea* p]son t manufactures1      
introduces1 deliv]s = introduction1 or  
receives a food sub/ance 9 int]/ate     
comm]ce t is subject to a reassessm5t "u
 subsection 7m7 ( section #dji1 =       
purposes ( conduct+ su* reassessm5t4  2 
7#b7 9 subsection 7b7--  7,a7 9 p>agraph
 7#b77;,a7-- 7i7 9 clause 7iii71 by     
/rik+ & at ! end2  7ii7 9 clause 7iv71  
by /rik+ ! p]iod at ! end & ins]t+ 2 &2 
&  7iii7 by add+ at ! end ! foll[+3  7v7
 "u subp>agraph 7,e7 or 7,f7 (          
subsection 7a77#a7 = a fiscal ye> %all  
be bas$ on ! ,secret>y's e/imate ( #ajj 
p]c5t ( ! co/s ( ! activities describ$ 9

 su* subp>agraph 7,e7 or 7,f7 = su* ye>4
  2 &  7,b7 9 p>agraph 7#c71 by /rik+   
clause 7i71 7ii71 7iii71 & 7iv7 ea*     
place x appe>s & ins]t+ clause 7i71     
7ii71 7iii71 7iv71 & 7v72 &  7#c7 9     
subsection 7c7-- 7,a7 9 p>agraph 7#a7-- 
7i7 by /rik+ fiscal ye> #bjaj & ins]t+  
fiscal ye> #bjbf2 &  7ii7 by /rik+      
fiscal ye> #bjji & ins]t+ fiscal ye>    
#bjbe2 &  7,b7 9 p>agraph 7#c77;,b71 by 
/rik+ fiscal ye> #bjji & ins]t+ fiscal  
ye> #bjbe4