,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bcda  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ag1 #bjbe,mr4   
,m>key 7= himself1 ,mr4 ,book]1 ,ms4    
,w>r51 & ,mr4 ,blum5?al7 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to impose requirem5ts = sub/ances       
g5]ally recogniz$ z safe1 to require !  
,commission] ( ,food & ,drugs to        
reassess ! safety ( *emicals add$ to    
food1 & = o!r purposes4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,ensur+ ,safe
 & ,toxic-,free ,foods ,act ( #bjbe4    
#b4 ,sub/ances g5]ally recogniz$ z safe 
7a7 ,9 g5]al ,*apt] ,,iv ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by ins]t+ aft] section #dji 7#ba        
,u4,s4,c4 #cdh7 ! foll[+3  #dji;,a4     
,sub/ances g5]ally recogniz$ z safe  7a7
 ,9 g5]al ,any sub/ance ! int5d$ use (  
:i* results or may reasonably be expect$
 to result1 directly or indirectly1 9   

its becom+ a compon5t or o!rwise affect+
 ! *>act]i/ics ( any food 7includ+ any  
sub/ance int5d$ = use 9 produc+1        
manufactur+1 pack+1 process+1 prep>+1   
treat+1 packag+1 transport+1 or hold+   
food2 & includ+ any s\rce ( radiation   
int5d$ = any su* use71 %all1 ) respect  
to any p>ticul> use or int5d$ use1 be   
deem$ to be unsafe = ! purposes ( !     
application ( clause 7#b77;,c7 ( section
 #djb7;a71 unless-- 7#a7 su* sub/ance is
 a food additive 9 compliance ) section 
#dji2  7#b7 subject to subsection       
7e77#b71 ! manufactur] has submitt$1    
prior to ! date ( enactm5t ( ! ,ensur+  
,safe & ,toxic-,free ,foods ,act (      
#bjbe1 a notice to ! ,secret>y t !      
manufactur] has conclud$ t su* sub/ance 
is g5]ally recogniz$ z safe "u !        
conditions ( its int5d$ use1 & !        
,secret>y has n issu$ a response or has 
issu$ a response /at+ t ! ,secret>y does
 n "q ! basis = su* conclusion2 or  7#c7
 7,a7 ! manufactur] has submitt$1 dur+ !
 p]iod beg9n+ on ! date ( enactm5t ( !  

,ensur+ ,safe & ,toxic-,free ,foods ,act
 ( #bjbe & end+ on ! day be=e !         
effective date describ$ 9 section #b7;d7
 ( su* ,act1 a notice to ! ,secret>y t !
 manufactur] has det]m9$ su* sub/ance to
 be g5]ally recogniz$ z safe "u !       
conditions ( its int5d$ use2  7,b7 su*  
notice includes support+ in=mation      
suffici5t to ju/ify ! basis ( su*       
det]m9ation1 includ+ full reports (     
inve/igations made ) respect to ! safety
 = use ( su* sub/ance1 includ+-- 7i7    
full in=mation z to ! me?ods & controls 
us$ 9 conduct+ su* inve/igations2  7ii7 
in=mation on ! cumulative effects ( su* 
sub/ance2  7iii7 in=mation on haz>d1    
dose response1 & exposure2  7iv7        
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  7v7
 in=mation demon/rat+ t ! weight ( !    
evid5ce analysis %[s t su* sub/ance has 
n be5 f\nd to be c>c9og5ic2 &  7vi7     

in=mation demon/rat+ t ! weight ( !     
evid5ce analysis %[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,c7 !       
,secret>y has n object$ to su*          
det]m9ation "u subsection 7c74  7b7     
,public availability & comm5t ,on       
receipt ( a notice ( a det]m9ation      
describ$ 9 subsection 7a77#c77;,a71 !   
,secret>y %all-- 7#a7 make su* notice & 
! support+ in=mation includ$ ) su*      
notice publicly available on ! website (
 ! ,food & ,drug ,adm9i/ration2 &  7#b7 
provide an opportunity = public comm5t =
 a p]iod ( n less ?an #fj days4  7c7    
,det]m9ation ( ,secret>y  7#a7 ,9 g5]al 
,! ,secret>y %all issue a writt5 /atem5t
 object+ to a det]m9ation describ$ 9    
subsection 7a77#c77;,a7 if #a or m ( !  
crit]ia describ$ 9 p>agraph 7#b7 are n  
met4  7#b7 ,crit]ia ,! crit]ia describ$ 
9 ?is p>agraph are ! foll[+3 7,a7 ,!    
manufactur] has submitt$ complete       

docum5tation ju/ify+ ! basis = its      
det]m9ation z describ$ 9 subsection     
7a77#c77;,b74  7,b7 ,) respect to data  
us$ = su* ju/ification t 0 provid$ by an
 exp]t1 su* exp]t does n h a conflict ( 
int]e/4  7,c7 ,! available evid5ce      
adequately supports a det]m9ation t !   
sub/ance is g5]ally recogniz$ z safe "u 
! conditions ( its int5d$ use4  7#c7    
,det]m9ation n to object ,) respect to a
 det]m9ation describ$ 9 subsection      
7a77#c77;,a71 if ! ,secret>y det]m9es t 
all ( ! crit]ia describ$ 9 p>agraph 7#b7
 are met1 ! ,secret>y %all issue a      
writt5 /atem5t t ! ,secret>y is n       
object+ to su* det]m9ation describ$ 9   
subsection 7a77#c77;,a74  7#d7          
,additional in=mation ,be=e object+ to a
 det]m9ation describ$ 9 subsection      
7a77#c77;,a71 ! ,secret>y may reque/    
additional in=mation f ! manufactur] if 
! ,secret>y det]m9es ! manufactur] has  
fail$ to submit complete docum5tation   
ju/ify+ ! basis = its det]m9ation z     
describ$ 9 subsection 7a77#c77;,b74     

7#e7 ,f9al ag5cy action ,! det]m9ation (
 ! ,secret>y to object or n to object "u
 ?is subsection to a det]m9ation        
describ$ 9 subsection 7a77#c77;,a7 %all 
be consid]$ to be a f9al ag5cy action4  
7#f7 ,publication ,! ,secret>y %all     
publi% ! basis ( a det]m9ation to object
 or to n object "u ?is subsection to a  
det]m9ation describ$ 9 subsection       
7a77#c77;,a7 on ! website ( ! ,food &   
,drug ,adm9i/ration1 includ+ any *emi/ry
 & toxicology memor&a produc$ or reli$  
on by ! ,secret>y 9 mak+ su*            
det]m9ation4 ,failure to publi% su* a   
det]m9ation %all n be con/ru$ z an      
affirmative f9d+ by ! ,secret>y t !     
sub/ance is g5]ally recogniz$ z safe4   
7#g7 ,def9ition ( conflict ( int]e/ ,9  
?is subsection1 ! t]m conflict ( int]e/ 
means a 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  7d7 ,/&>ds = exp]ts evaluat+   
:e!r a sub/ance is ,,gras ,n lat] ?an   
#ahj days aft] ! date ( enactm5t ( !    
,ensur+ ,safe & ,toxic-,free ,foods ,act
 ( #bjbe1 ! ,secret>y %all issue        
guidance to /r5g!n ! recomm5dations     
conta9$ 9 ! ,decemb] #bjbb guidance ( ! 
,food & ,drug ,adm9i/ration entitl$ ,be/
 ,practices = ,conv5+ a ,,gras ,panel4  
7e7 ,reassessm5t  7#a7 ,9 g5]al ,)      
respect to a sub/ance = :i* ! ,secret>y 
has det]m9$ "u subsection 7c77#c7 n to  
object to ! manufactur]'s det]m9ation "u
 subsection 7a77#c77;,a7 t su* sub/ance 
is g5]ally recogniz$ z safe "u !        
conditions ( its int5d$ use1 ! ,secret>y
 may1 at any "t-- 7,a7 reassess 9       
accordance ) subsection 7c7 :e!r su*    
sub/ance is g5]ally recogniz$ z safe "u 
! conditions ( its int5d$ use2 &  7,b7  
pursuant to su* reassessm5t1 )draw !    
det]m9ation ( ! ,secret>y n to object "u
 subsection 7c77#c74  7#b7 ,prior       
submissions to ,,gras notification      
program ,! ,secret>y may require !      

manufactur] ( a sub/ance describ$ 9     
subsection 7a77#b7 to submit a notice = 
su* sub/ance t includes ! in=mation     
describ$ 9 subsection 7a77#c74 ,!       
,secret>y %all review su* notice 9      
accordance ) subsections 7b7 & 7c74  7f7
 ,timel9e = review ( ,,gras submissions 
7#a7 ,9 g5]al ,! ,secret>y %all review n
 few] ?an #ej notices describ$ 9        
p>agraphs 7#b7 & 7#c7 ( subsection 7a7  
ea* ye> until all su* notices h be5     
review$4  7#b7 ,requirem5ts ,9 conduct+ 
a review describ$ 9 p>agraph 7#a71 !    
,secret>y %all-- 7,a7 ) respect to a    
notic$ describ$ 9 subsection 7a77#b71   
issue a response to su* notice /at+ t1 z
 applicable-- 7i7 ! ,secret>y does n "q 
! basis = su* conclusion2 or  7ii7 !    
,secret>y has conclud$ t su* notice does
 n provide a suffici5t basis = su*      
conclusion2 &  7,b7 ) respect to a      
notice describ$ 9 subsection 7a77#c71   
issue a response 9 accordance )1 z      
applicable1 p>agraph 7#a7 or 7#c7 (     
subsection 7c74  7g7 ,def9itions ,9 ?is 

section3 7#a7 ,c>c9og5ic  7,a7 ,9 g5]al 
,! t]m c>c9og5ic1 ) respect to a        
sub/ance1 means su* sub/ance is f\nd to 
induce canc] :5 +e/$ by humans or       
animals1 or is f\nd1 aft] te/s t are    
appropriate = ! evaluation ( ! safety ( 
sub/ances1 to induce canc] 9 humans or  
animals4  7,b7 ,requirem5t ,9 det]m9+   
:e!r a sub/ance is c>c9og5ic = purposes 
( subp>agraph 7,a71 ! ,secret>y %all    
consid] assessm5ts conduct$ by          
au?oritative bodies1 includ+ ! ,national
 ,toxicology ,program1 ! ,int]national  
,ag5cy = ,rese>* on ,canc]1 & !         
,environm5tal ,protection ,ag5cy4  7#b7 
,cumulative effects ,! t]m cumulative   
effects1 ) respect to a sub/ance1 means 
! comb9$ heal? effects ( all *emically  
or ph>macologically relat$ sub/ances4   
7#c7 ,developm5tal toxicity ,! t]m      
developm5tal toxicity1 ) respect to !   
effect ( exposure to a sub/ance on a    
human or animal1 means 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#d7 ,g5]ally         
recogniz$ z safe  7,a7 ,9 g5]al ,! t]m  
g5]ally recogniz$ z safe1 ) respect to a
 sub/ance1 means 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  7,b7 ,exclusions ,! t]m
 g5]ally recogniz$ z safe1 ) respect to 
a sub/ance1 does n include a sub/ance   
t-- 7i7 is c>c9og5ic2  7ii7 %[s evid5ce 
( reproductive toxicity or developm5tal 
toxicity2  7iii7 is o!rwise id5tifi$ z  
toxic by ! ,national ,toxicology        
,program1 ! ,environm5tal ,protection   
,ag5cy1 ! ,ag5cy = ,toxic ,sub/ances &  
,disease ,regi/ry1 or ! ,cali=nia ,(fice

 ( ,environm5tal ,heal? ,haz>d          
,assessm5t2  7iv7 0 n m>ket$ = use 9    
foods 9 ! ,unit$ ,/ates prior to ! date 
( enactm5t ( ! ,ensur+ ,safe &          
,toxic-,free ,foods ,act ( #bjbe2 or    
7v7 0 n syn!siz$1 *>act]iz$1 or isolat$ 
prior to ! date ( enactm5t ( ! ,ensur+  
,safe & ,toxic-,free ,foods ,act (      
#bjbe4  7#e7 ,reproductive toxicity ,!  
t]m reproductive toxicity1 ) respect to 
! effect ( exposure to a sub/ance on a  
human or animal1 means 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  7h7  
,au?orization ( appropriations ,!re are 
au?oriz$ to be appropriat$ to c>ry out  
?is section su* sums z are necess>y4  4 
7b7 ,adult]ation ,section               
#djb7;a77#b77;,c77i7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  

#cdb7;a77#b77;,c77i77 is am5d$ by ins]t+
 or any o!r sub/ance t is n g5]ally     
recogniz$ z safe 9 compliance ) section 
#dji;,a aft] section #dji4  7c7         
,def9itions ,section #bja7s7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7s77 is am5d$-- 7#a7 by   
/rik+ if su* sub/ance is n 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$ use22  7#b7 9 p>agraph 7#e71 
by /rik+ or at ! end2  7#c7 9 p>agraph  
7#f71 by /rik+ ! p]iod & ins]t+ 2 or2 & 
7#d7 by add+ at ! end ! foll[+3  7#g7 a 
sub/ance g5]ally recogniz$ z safe 9     
compliance ) section #dji;,a4  4  7d7   
,effective date ,! am5dm5ts made by ?is 
section %all take effect on ! date t is 
#b ye>s aft] ! date ( enactm5t ( ?is    

,act4  #c4 ,food *emical reassessm5t    
,*apt] ,,iv ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cda et   
seq47 is am5d$ by ins]t+ aft] section   
#dji;,a 7z add$ by section #b7;a77 !    
foll[+3  #dji;,b4 ,food *emical         
reassessm5t  7a7 ,safety reassessm5ts   
7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] !
 date ( enactm5t ( ?is section1 & n less
 frequ5tly ?an once e #c ye>s !reaft]1 !
 ,secret>y %all reassess ! safety1 )9 ! 
mean+ ( section #dji or section #dji;,a1
 ( n less ?an #aj sub/ances or classes (
 sub/ances-- 7,a7 to det]m9e if su*     
sub/ance or class ( sub/ances is safe )9
 ! mean+ ( section #dji or section      
#dji;,a2 &  7,b7 to e/abli% ! conditions
 ( use1 if any1 "u :i* any su* sub/ance 
or class ( sub/ances may be us$ safely  
)9 ! mean+ ( su* section #dji or        
#dji;,a4  7#b7 ,requirem5ts =           
manufactur]s ,! ,secret>y may require   
any manufactur] ( a sub/ance or class ( 
sub/ances t is be+ reassess$ "u p>agraph
 7#a7 to provide data or to conduct     

evaluations ( su* sub/ance or class (   
sub/ances = purposes ( ! reassessm5t "u 
p>agraph 7#a74  7#c7 ,priority ,!       
,secret>y may give priority to !        
reassessm5t ( a sub/ance or class (     
sub/ances t is ! subject (-- 7,a7 a food
 additive petition "u section #dji7;b72 
7,b7 a color additive petition "u       
section #gba7;d72 or  7,c7 a citiz5     
petition to reque/ ! reassessm5t1       
re/riction1 or revocation ( an exi/+    
au?orization ( su* sub/ance or class (  
sub/ances4  7b7 ,consid]ations ,9       
det]m9+1 = ! purposes ( ?is section1    
:e!r a sub/ance or class ( sub/ances is 
unsafe )9 ! mean+ ( section #dji or     
section #dji;,a1 ! ,secret>y %all       
consid] ! in=mation describ$ 9 clauses  
7i7 ?r\gh 7vi7 ( section                
#dji;,a7a77#c77;,b74  7c7 ,rule (       
con/ruction ,no?+ 9 ?is section alt]s ! 
au?ority or duties ( ! ,secret>y )      
respect to ! adm9i/ration & en=cem5t (  
section #dji or section #dji;,a4  4