,,ii  #aah? ,,congress  #a/ ,session    
,s4 #cchg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #d1 #bjbc,mr4 
,m>key 7= himself1 ,mr4 ,book]1 ,mr4    
,blum5?al1 & ,ms4 ,w>r57 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
direct ! ,secret>y ( ,heal? & ,human    
,s]vices to update & cl>ify its rule on 
sub/ances g5]ally recogniz$ z safe & to 
e/abli% )9 ! ,food & ,drug ,adm9i/ration
 ! ,(fice ( ,food ,*emical ,safety1     
,diet>y ,supplem5ts1 & ,innovation1 & = 
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,ensur+ ,safe &        
,toxic-,free ,foods ,act ( #bjbc4  #b4  
,direct$ rulemak+ reg>d+ sub/ances      
g5]ally recogniz$ z safe  7a7           
,def9itions ,9 ?is section3 7#a7 ,,gras 
,! t]m ,,gras1 ) respect to ! use ( a   
sub/ance 9 food1 has ! mean+ giv5 ! t]m 
g5]ally recogniz$ z safe = use 9 food 9 
section #dji;,a7a7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act1 z add$ by      

section #c4  7#b7 ,reproductive or      
developm5tal toxicity ,! t]m            
reproductive or developm5tal toxicity   
has ! mean+ giv5 su* t]m 9 su* section  
#dji;,a7a74  7#c7 ,secret>y ,! t]m      
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs4  7#d7    
,vuln]able human populations ,! t]m     
vuln]able human population has ! mean+  
giv5 su* t]m 9 su* section #dji;,a7a74  
7b7 ,direct$ rulemak+  7#a7 ,9 g5]al ,! 
,secret>y %all-- 7,a7 n lat] ?an #a ye> 
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$4 ,reg4 #edifj72  7,b7 n lat] ?an    
#ahj days aft] ! close ( ! p]iod =      
public comm5t on ! revision propos$ "u  
subp>agraph 7,a71 publi% a f9al revision
 to su* f9al rule2 &  7,c7 n lat] ?an   
#ahj days aft] ! date ( enactm5t ( ?is  
,act1 publi% a plan = monitor+ indu/ry  

compliance ) ! rules1 regulations1 &    
guidance ( ! ,food & ,drug ,adm9i/ration
 relat+ to ,,gras1 includ+ ! ,decemb]   
#bjbb guidance titl$ ,be/ ,practices =  
,conv5+ a ,,gras ,panel4  7#b7 ,cont5ts 
,! revision requir$ by subp>agraphs 7,a7
 & 7,b7 ( 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 made a f9al
 det]m9ation1 :i* is convey$ to !       
manufactur] 9 writ+1 t ! ,secret>y has  
receiv$ suffici5t notice f ! manufactur]
 t ! manufactur] has det]m9$ su*        
sub/ance to be ,,gras "u ! conditions ( 
its int5d$ use2 &  7ii7 ! manufactur]   
has provid$ ! ,secret>y ) support+      
in=mation suffici5t to und]/& ! basis ( 
! det]m9ation1 includ+-- 7,i7 !         
cumulative effects ( ! sub/ance1 z      
requir$ "u section #dji ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     

,u4,s4,c4 #cdh72  7,,ii7 an adequately  
protective use ( safety factors1 z      
describ$ "u su* section #dji1 includ+   
safety factors to acc\nt = ! p>ticul>   
s5sitivities ( vuln]able human          
populations1 to ! ext5t t data are      
available to d]ive safety factors = ea* 
vuln]able human population2  7,,iii7    
in=mation demon/rat+ t ! weight (       
evid5ce analysis %[s ! sub/ance has n   
be5 f\nd to induce canc] :5 +e/$ by     
humans or animals2 &  7,,iv7 in=mation  
demon/rat+ t ! weight ( evid5ce analysis
 %[s ! sub/ance has n be5 f\nd to induce
 reproductive or developm5tal toxicity  
:5 +e/$ by humans or animals1 includ+   
?r\gh an endocr9e mode ( action4  7,b7  
,! revision %all require-- 7i7 !        
,secret>y 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 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 li/$ 9           
subp>agraph 7,a7 & 9 p>agraphs 7#c7     
?r\gh 7#e7 ( section #dji7;c7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cdh7;c772 &  7iii7 !         
,secret>y's objection1 or decision n to 
object1 to be consid]$ f9al ag5cy       
action4  7,c7 ,! revision %all cl>ify t 
sub/ances t are kn[n 7or reasonably     
anticipat$7 to cause canc] 9 humans or  
animals id5tifi$ by ! ,national         
,toxicology ,program _c be ,,gras4  7,d7
 ,! revision %all cl>ify t sub/ances t  
%[ cle> evid5ce 7or "s evid5ce7 ( human 
reproductive or developm5tal toxicity   
id5tifi$ by ! ,national ,toxicology     
,program _c be ,,gras4  7,e7 ,! revision
 %all cl>ify t any sub/ance t 0 n m>ket$
 = use 9 foods 9 ! ,unit$ ,/ates be=e   
issuance ( ! revis$ rule _c be ,,gras & 
%all be approv$ by ! ,secret>y ?r\gh a  
food additive petition z requir$ by     

section #dji7;c7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cdh7;c77 prior to be+ m>ket$ 9 food4   
7,f7 ,! revision %all-- 7i7 incorporate 
/&>ds prohibit+ conflict ( int]e/s among
 exp]ts provid+ data = sub/ances        
submitt$ = ,,gras review2 &  7ii7       
incorporate measures to /r5g!n !        
recomm5dations 9 ! ,decemb] #bjbb       
guidance ( ! ,food & ,drug ,adm9i/ration
 titl$ ,be/ ,practices = ,conv5+ a      
,,gras ,panel4  7,g7 ,! revision %all   
create a process t requires ! ,secret>y 
to sy/ematically reassess any sub/ance t
 0 det]m9$ to be ,,gras if ! initial    
det]m9ation did n meet ! revis$ /&>ds = 
su* a det]m9ation1 9 accordance ) !     
proc$ures & res\rces 9 section #dji;,a (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic     
,act1 z add$ by section #c4  #c4 ,(fice 
( ,food ,*emical ,safety1 ,diet>y       
,supplem5ts1 & ,innovation ,*apt] ,,iv (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cda et seq47 is am5d$  
by ins]t+ aft] section #dji 7#ba        

,u4,s4,c4 #cdh7 ! foll[+3  #dji;,a4     
,(fice ( ,food ,*emical ,safety1 ,diet>y
 ,supplem5ts1 & ,innovation  7a7        
,def9itions ,9 ?is section3 7#a7 ,food  
contact sub/ance ,! t]m food contact    
sub/ance has ! mean+ giv5 su* t]m 9     
section #dji7;h77#f74  7#b7 ,g5]ally    
recogniz$ z safe = use 9 food ,! t]m    
g5]ally recogniz$ z safe = use 9 food   
means1 ) respect to ! use ( a sub/ance 9
 food1 t ! 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$ use1 z describ$ 9 section    
#bja7s74  7#c7 ,prior-sanction$ sub/ance
 ,! t]m prior-sanction$ sub/ance means a
 sub/ance describ$ 9 p>agraph 7#d7 (    
section #bja7s74  7#d7 ,reproductive or 
developm5tal toxicity ,! t]m            

reproductive or developm5tal toxicity   
means-- 7,a7 adv]se effects on !        
reproductive sy/ems ( female or male    
humans or animals1 t may include        
alt]ations to ! female or male          
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/em2 or    
7,b7 adv]se effects on develop+         
organisms t result f exposure prior to  
conception1 dur+ ! pr5atal p]iod1 or    
until ! "t ( sexual maturity4  7#e7     
,vuln]able human population ,! t]m      
vuln]able human population means a human
 population t is subject to ! pot5tial =
 disproportionate exposure to1 or !     
pot5tial = disproportionate adv]se      
effects f exposure to1 a *emical        
sub/ance or mixture1 includ+-- 7,a7     
infants1 *ildr51 & adolesc5ts2  7,b7    
pregnant1 po/p>tum1 or brea/fe$+ wom52  
7,c7 old] adults2  7,d7 individuals )   
preexi/+ m$ical conditions2  7,e7 work]s

 :o may be expos$ to *emical sub/ances &
 mixtures2  7,f7 resid5ts 9 communities 
subject to disproportionate exposures or
 adv]se effects2 &  7,g7 memb]s ( any   
o!r appropriate population id5tifi$ by !
 ,secret>y4  7b7 ,e/abli%m5t ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is    
section1 ! ,secret>y %all e/abli% )9 !  
,food & ,drug ,adm9i/ration an (fice1 to
 be kn[n z ! ,(fice ( ,food ,*emical    
,safety1 ,diet>y ,supplem5ts1 &         
,innovation 7ref]r$ to 9 ?is section z !
 ,(fice71 to evaluate & reassess !      
safety1 )9 ! mean+ ( section #dji1 (    
sub/ances & classes ( sub/ances1 includ+
 food additives1 food contact sub/ances1
 sub/ances g5]ally recogniz$ z safe =   
use 9 food1 color additives1 &          
prior-sanction$ sub/ances4  7c7 ,safety 
reassessm5ts ,n lat] ?an #c ye>s aft] ! 
date on :i* ! ,(fice is e/abli%$1 & n   
less frequ5tly ?an once e #c ye>s       
!reaft]1 ! ,(fice %all-- 7#a7 reassess !
 safety ( n less ?an #aj ( ! sub/ances  
or classes ( sub/ances describ$ 9       

subsection 7b72 &  7#b7 issue f9al      
regulations-- 7,a7 det]m9+ t any su*    
sub/ance or class ( sub/ance is safe )9 
! mean+ ( section #dji & e/abli%+ !     
conditions ( use1 if any1 "u :i* any su*
 sub/ance or class ( sub/ances c be us$ 
safely )9 ! mean+ ( su* section2 or     
7,b7 det]m9+ t any su* sub/ance or class
 ( sub/ances is unsafe )9 ! mean+ ( su* 
section4  7d7 ,consid]ations ,9 det]m9+1
 = ! purposes ( ?is section1 :e!r a     
sub/ance or class ( sub/ances is unsafe 
)9 ! mean+ ( section #dji1 ! ,secret>y  
%all consid] among o!r relevant         
factors-- 7#a7 ! cumulative effects ( ! 
sub/ance1 z describ$ "u su* section     
#dji2 &  7#b7 an adequately protective  
use ( safety factors1 z describ$ "u su* 
section #dji1 includ+ safety factors to 
acc\nt = ! p>ticul> s5sitivities (      
vuln]able human populations4  7e7       
,notice prior to select+ sub/ances =    
reassessm5t ,prior to select+ sub/ances 
or classes ( sub/ances to reassess "u   
subsection 7c71 ! ,secret>y %all po/ a  

notice 9 ! ,f$]al ,regi/] reque/+       
in=mation & recomm5dations on :i*       
sub/ances & classes %\ld be reassess$4  
,! in=mation %all include sub/ance or   
class "n1 uses1 & data relat+ to !      
actual & pot5tial haz>ds & impact on    
public heal?4  7f7 ,notice prior to     
comm5cem5t ,prior to comm5c+ a          
reassessm5t ( a sub/ance or class (     
sub/ances "u subsection 7c71 ! ,secret>y
 %all po/ a notice 9 ! ,f$]al ,regi/]   
reque/+ in=mation on any uses ( su*     
sub/ance or class 9 food1 includ+ z a   
prior-sanction$ sub/ance1 food contact  
sub/ance1 or sub/ance t is g5]ally      
recogniz$ z safe = use 9 food4 ,!       
in=mation reque/$ %all include :5 ! uses
 comm5c$1 ! specific conditions ( use1  
h[ !y 7 det]m9$ to be safe1 sci5tific   
evid5ce relevant to ! safety ( !        
sub/ance t has become available s9ce its
 use 9 food comm5c$1 & ! anticipat$     
am\nts t may be f\nd 9 food4  7g7 ,food 
,*emical ,committee ( ! ,sci5ce ,bo>d ,n
 lat] ?an #ahj days aft] ! date (       

enactm5t ( ?is section1 ! ,secret>y %all
 e/abli% a /&+ ,food ,*emical ,committee
 7ref]r$ to 9 ?is subsection z !        
,committee7 )9 ! ,sci5ce ,bo>d to !     
,food & ,drug ,adm9i/ration & provide   
res\rces & /aff+ z are necess>y = !     
,committee to meet regul>ly & complete  
_! "w4 ,! ,committee %all advise !      
,secret>y ) respect to ! process &      
me?ods necess>y to complete ! "w ( !    
,(fice4  7h7 ,rule ( con/ruction ,no?+ 9
 ?is section alt]s ! au?ority or duties 
( ! ,secret>y ) respect to !            
adm9i/ration & en=cem5t ( section #dji4 
4