,,ii  #aac? ,,congress  #a/ ,session    
,s4 #ajji  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bb1 #bjac ,mr4   
,laut5b]g 7= himself1 ,mr4 ,vitt]1 ,mrs4
 ,gillibr&1 ,mr4 ,crapo1 ,mr4 ,durb91   
,mr4 ,alex&]1 ,mr4 ,s*um]1 ,mr4 ,inh(e1 
,mr4 ,udall ( ,new ,mexico1 ,ms4        
,coll9s1 ,ms4 ,l&rieu1 ,mr4 ,rubio1 ,mr4
 ,man*91 ,mr4 ,boozman1 ,mr4 ,m55dez1   
,mr4 ,hoev51 & ,mr4 ,begi*7 introduc$ ! 
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,environm5t & ,public
 ,works  ,a ,,bill  ,to reau?orize &    
mod]nize ! ,toxic ,sub/ances ,control   
,act1 & = o!r purposes4  #a4 ,%ort      
title2 table ( cont5ts2 ref]5ces  7a7   
,%ort title ,?is ,act may be cit$ z !   
,*emical ,safety ,improvem5t ,act4  7b7 
,table ( cont5ts ,! table ( cont5ts =   
?is ,act is z foll[s3  ,sec4 #a4 ,%ort  
title2 table ( cont5ts2 ref]5ces4 ,sec4 
#b4 ,f9d+s1 policy1 & int5t4 ,sec4 #c4  
,def9itions4 ,sec4 #d4 ,*emical         
assessm5t framework2 prioritization     
scre5+2 te/+4 ,sec4 #e4 ,new *emicals & 

significant new uses4 ,sec4 #f4 ,safety 
assessm5ts & det]m9ations4 ,sec4 #g4    
,imm95t haz>ds4 ,sec4 #h4 ,in=mation    
collection & report+4 ,sec4 #i4         
,relation%ip to o!r ,f$]al laws4 ,sec4  
#aj4 ,rese>*1 developm5t1 collection1   
dissem9ation1 & utilization ( data4     
,sec4 #aa4 ,exports4 ,sec4 #ab4         
,imports4 ,sec4 #ac4 ,confid5tial       
in=mation4 ,sec4 #ad4 ,prohibit$ acts4  
,sec4 #ae4 ,preemption4 ,sec4 #af4      
,judicial review4 ,sec4 #ag4 ,citiz5s'  
petitions4 ,sec4 #ah4 ,/udies4 ,sec4    
#ai4 ,adm9i/ration4 ,sec4 #bj4          
,developm5t & evaluation ( te/ me?ods4  
,sec4 #ba4 ,/ate programs4 ,sec4 #bb4   
,au?orization ( appropriations4 ,sec4   
#bc4 ,annual report4  7c7 ,ref]5ces     
,except z o!rwise expressly provid$1    
:]ev] 9 ?is ,act an am5dm5t or repeal is
 express$ 9 t]ms ( an am5dm5t to1 or    
repeal (1 a section or o!r provision1 ! 
ref]5ce %all be consid]$ to be made to a
 section or o!r provision ( ! ,toxic    
,sub/ances ,control ,act 7#ae ,u4,s4,c4 

#bfja et seq474  #b4 ,f9d+s1 policy1 &  
int5t  7a7 ,purposes ,! purposes ( ?is  
,act are--  7#a7 to improve ! safety (  
consum]s 9 ! ,unit$ ,/ates2 &  7#b7 to  
ensure t risks f *emical sub/ances are  
adequately und]/ood & manag$ by mod]niz+
 title ,i ( ! ,toxic ,sub/ances ,control
 ,act 7#ae ,u4,s4,c4 #bfja et seq474    
7b7 ,f9d+s1 policy1 & int5t ,section #b 
7#ae ,u4,s4,c4 #bfja7 is am5d$ by /rik+ 
subsections 7a7 ?r\gh 7c7 & ins]t+ !    
foll[+3  7a7 ,f9d+s ,congress f9ds t--  
7#a7 *emicals %\ld be safe = ! int5d$   
use ( ! *emicals2  7#b7 ! unmanag$ risks
 ( *emical sub/ances may pose a dang] to
 human heal? & ! environm5t2  7#c7      
public confid5ce 9 ! ,f$]al *emical     
regulatory program has dim9i%$ ov] "t2  
7#d7 sci5tific und]/&+ ( *emicals & !   
possible risks ( ! *emicals has evolv$  
greatly s9ce #aigf1 requir+ t ,congress 
update ! law to ensure t *emical        
regulation 9 ! ,unit$ ,/ates reflects   
mod]n sci5ce1 te*nology & k2  7#e7 ?is  
,act %\ld be mod]niz$ to create a robu/ 

,f$]al sy/em = assess+ & manag+ *emical 
risks2  7#f7 *emicals are us$ 9 div]se  
manufactur+ indu/ries & o!r valuable    
comm]cial1 in/itutional1 & consum]      
applications t h b5efitt$ society2  7#g7
 = ! purposes ( promot+ uni=m           
protections ?r\gh regulation ( *emical  
sub/ances 9 comm]ce1 to m9imize undue   
burd5s on comm]ce1 & to m9imize burd5s  
on ,/ates1 specifi$ actions by !        
,adm9i/rator %\ld preempt requirem5ts by
 ,/ates & political subdivisions (      
,/ates t relate to ! effects ( or       
exposure to a *emical sub/ance "u !     
int5d$ conditions ( use2 &  7#h7        
innovation 9 ! developm5t ( new *emical 
sub/ances1 especially saf] *emical      
sub/ances1 %\ld be enc\rag$ to r$uce    
risk1 provide improv$ products1 /imulate
 ! economy1 create jobs1 & protect      
int]/ate comm]ce4  7b7 ,policy ,x is !  
policy ( ! ,unit$ ,/ates t--  7#a7 ?is  
,act--  7,a7 %\ld protect ! heal? ( p & 
! environm5t f ! unmanag$ risks (       
*emical sub/ances2 &  7,b7 %\ld be      

mod]niz$ to build public confid5ce 9 !  
ability ( ! ,f$]al regulatory sy/em to  
protect heal? & ! environm5t1 promote   
innovation1 & su/a9 a globally          
competitive *emical indu/ry 9 ! ,unit$  
,/ates2  7#b7 ! ,adm9i/rator--  7,a7    
%\ld h ! appropriate haz>d1 use1 &      
exposure in=mation necess>y to make     
safety det]m9ations2  7,b7 %\ld m9imize 
! use ( animal te/+ ?r\gh ! use (       
sci5tifically reliable & relevant te/   
me?ods1 :]e appropriate2  7,c7 %\ld     
enc\rage ! use ( be/ laboratory         
practices to ensure high quality1       
relevant1 & reliable results f te/      
me?ods & /udies2  7,d7 %\ld h ! au?ority
 to %>e confid5tial bus9ess in=mation ) 
,/ates & political subdivisions ( !     
,/ates1 subject to appropriate safegu>ds
 aga9/ inappropriate disclosure2  7,e7  
%\ld h ! res\rces & tools necess>y to   
implem5t ?is ,act2 &  7,f7 %\ld implem5t
 ?is ,act 9 a mann] t promotes          
transp>5cy ( in=mation & decisionmak+1  
protects sub/antiat$ confid5tial bus9ess

 in=mation1 & promotes innovation1      
includ+ innovation 9 *emical sub/ances t
 h r$uc$ haz>d1 exposure1 & risk        
patt]ns2  7#c7 adequate data & in=mation
 %\ld be available ) respect to ! effect
 ( & exposure to *emical sub/ances &    
mixtures on heal? & ! environm5t1 to !  
ext5t necess>y = safety assessm5ts &    
det]m9ations1 & t1 :]e necess>y1 !      
developm5t ( su* te/ data & in=mation   
%\ld be ! prim>y responsibility ( ^? :o 
manufacture or process su* *emical      
sub/ances & mixtures2 &  7#d7 ,/ates h  
an important role 9 protect+ heal? & !  
environm5t f ! unmanag$ risks ( *emical 
sub/ances 9 comm]ce1 p>ticul>ly 9       
recomm5d+ priorities = ,f$]al assessm5t 
& regulation1 provid+ safety assessm5t  
in=mation1 & fo/]+ programs to protect  
consum]s4  7c7 ,int5t ( ,congress ,x is 
! int5t ( ,congress t ! ,adm9i/rator    
%all--  7#a7 rely on robu/ sci5tific    
evid5ce to implem5t ?is ,act 9 a way t  
balances ! mutual goals ( promot+ !     
safety ( ,am]ican consum]s & prev5t+ h>m

 to ,am]ican innovation1 manufactur+1 & 
! economy2 &  7#b7 implem5t ?is ,act to 
protect ! heal? ( ! p ( ! ,unit$ ,/ates 
& ! environm5t 9 su* a mann] z n to     
unduly imp$e comm]ce or create          
unnecess>y economic b>ri]s to           
te*nological innovation1 includ+ saf]   
*emi/ry4  4  #c4 ,def9itions ,section #c
 7#ae ,u4,s4,c4 #bfjb7 is am5d$--  7#a7 
by r$esignat+ p>agraphs 7#b7 ?r\gh 7#f71
 7#g7 ?r\gh 7#aa71 & 7#ab7 ?r\gh 7#ad7 z
 p>agraphs 7#c7 ?r\gh 7#g71 7#i7 ?r\gh  
7#ac71 & 7#ag7 ?r\gh 7#ai71             
respectively2  7#b7 by ins]t+ aft]      
p>agraph 7#a7 ! foll[+3  7#b7 ,be/      
available sci5ce ,! t]m be/ available   
sci5ce means sci5ce t--  7,a7 maximizes 
! quality1 objectivity1 & integrity (   
in=mation1 includ+ /ati/ical in=mation2 
7,b7 uses pe]-review$ & publically      
available data2 &  7,c7 cle>ly docum5ts 
& communicates risks & unc]ta9ties 9 !  
sci5tific basis = decisions4  2  7#c7 by
 ins]t+ aft] p>agraph 7#g7 7z s         
r$esignat$7 ! foll[+3  7#h7 ,int5d$     

conditions ( use ,! t]m int5d$          
conditions ( use means ! circum/ances "u
 :i* a *emical sub/ance is int5d$ or    
reasonably anticipat$ to be manufactur$1
 process$1 di/ribut$ 9 comm]ce1 us$1 &  
dispos$ (4  2 &  7#d7 by ins]t+ aft]    
p>agraph 7#ac7 7z s r$esignat$7 !       
foll[+3  7#ad7 ,safety assessm5t ,! t]m 
safety assessm5t means a risk-bas$      
assessm5t ( ! safety ( a *emical        
sub/ance t--  7,a7 integrates haz>d2    
use2 & exposure in=mation ab\t a *emical
 sub/ance2 &  7,b7 includes--  7i7 an   
assessm5t ( exposure "u ! int5d$        
conditions ( use2 &  7ii7 ref]5ce       
p>amet]s t may be appropriate ) reg>d to
 a specific *emical sub/ance 7su* z a   
m>g9 ( exposure74  7#ae7 ,safety        
det]m9ation ,! t]m safety det]m9ation   
means a det]m9ation by ! ,adm9i/rator z 
to :e!r a *emical sub/ance meets !      
safety /&>d "u ! int5d$ conditions (    
use4  7#af7 ,safety /&>d ,! t]m safety  
/&>d means a /&>d t ensures t no        
unreasonable risk ( h>m to human heal?  

or ! environm5t w result f exposure to a
 *emical sub/ance4  4  #d4 ,*emical     
assessm5t framework2 prioritization     
scre5+2 te/+  7a7 ,9 g5]al ,section #d  
7#ae ,u4,s4,c4 #bfjc7 is am5d$--  7#a7 9
 ! head+1 by /rik+ ,te/+ ( *emical      
sub/ances & mixtures & ins]t+ ,*emical  
assessm5t framework2 prioritization     
scre5+2 te/+4  7#b7 by r$esignat+       
subsection 7e7 z subsection 7l72  7#c7 9
 subsection 7l7 7z s r$esignat$7--  7,a7
 by /rik+ rule ea* place x appe>s &     
ins]t+ rule1 te/+ cons5t agreem5t1 or   
ord]2  7,b7 by /rik+ "u subsection 7a7  
ea* place x appe>s & ins]t+ "u ?is      
subsection2 &  7,c7 9 p>agraph          
7#a77;,b71 by /rik+ rulemak+2 &  7#d7 by
 /rik+ subsections 7a7 ?r\gh 7d71 7f71 &
 7g7 & ins]t+ ! foll[+3  7a7 ,*emical   
assessm5t framework  7#a7 ,9 g5]al ,!   
,adm9i/rator %all develop a framework 9 
accordance ) subsection 7e7 & sections  
#e & #f = evaluat+ ! safety ( *emical   
sub/ances 9 comm]ce t %all employ ! be/ 
available sci5ce & risk assessm5t       

pr9ciples 9 exi/5ce at ! "t !           
,adm9i/rator is develop+ ! framework4   
7#b7 ,policies & proc$ures  7,a7 ,9     
g5]al ,aft] ! date ( enactm5t ( !       
,*emical ,safety ,improvem5t ,act1 !    
,adm9i/rator %all promptly develop      
appropriate policies & proc$ures =      
implem5t+ ! framework1 includ+ proc$ures
 on ! collection1 evaluation1 &         
developm5t ( data & in=mation4  7,b7    
,cont5ts ,! policies & proc$ures %all   
require--  7i7 ! collection ( exi/+ data
 & in=mation f manufactur]s & processors
 ( *emical sub/ances & o!r s\rces1      
includ+ ! use ( volunt>y agreem5ts to   
provide ! data & in=mation2  7ii7 an    
evaluation ( ! quality ( exi/+ data &   
in=mation2  7iii7 an analysis ( data &  
in=mation2  7iv7 a det]m9ation ( ! ne$ =
 additional data & in=mation1 includ+   
in=mation relat$ to ! exposures (       
diff]5t subpopulations2 &  7v7 subject  
to section #ad1 transp>5cy ( data &     
in=mation consid]$ by ! ,adm9i/rator1   
includ+ bo? positive & negative f9d+s4  

7#c7 ,transp>5cy & validity ,!          
,adm9i/rator %all ensure t ! evaluation 
framework describ$ 9 subsection         
7a77#a7--  7,a7 is transp>5t2  7,b7     
assures t data & in=mation are valid2   
7,c7 addresses ! /r5g?s & limitations   
(--  7i7 ! design ( ! framework1  7ii7 !
 reliability ( ! te/ me?ods2 &  7iii7 ! 
quality ( ! data & in=mation2 &  7,d7   
pursues ! goal ( maximiz+ ! quality1    
objectivity1 utility1 & integrity ( !   
data & in=mation4  7b7 ,data & in=mation
 quality  7#a7 ,9 g5]al ,! ,adm9i/rator 
%all e/abli% & publi% sci5tifically s\nd
 crit]ia = evaluat+ all ( ! data &      
in=mation1 includ+ ! results ( animal & 
nonanimal te/+1 reg>dless ( affiliation 
or fund+ s\rce1 on :i* ! ,adm9i/rator   
relies 9 mak+ a decision "u ?is ,act4   
7#b7 ,disclosure ( s\rces ( fund+ ,!    
,adm9i/rator %all require t ! submitt] (
 any heal? & safety /udy disclose to !  
,adm9i/rator & to ! public ! s\rces (   
any fund+ us$ = ! /udy or publication ( 
! /udy receiv$ by ! rese>*] :o conduct$ 

! /udy1 to ! ext5t reasonably           
asc]ta9able4  7#c7 ,te/ data ,= te/ data
 develop$ "u ?is ,act1 ! ,adm9i/rator   
%all enc\rage ! use ( good laboratory   
practices1 pe] review1 sci5tifically    
reliable & relevant te/ me?ods1 /&>diz$ 
protocols1 & o!r me?ods to ensure       
sci5tific quality = all data & in=mation
 submitt$ "u ?is ,act4  7#d7 ,data &    
in=mation t d n meet crit]ia  7,a7 ,9   
g5]al ,no?+ 9 ?is subsection %all       
preclude ! ,adm9i/rator f consid]+ data 
& in=mation :i* d n meet ! quality      
crit]ia e/abli%$ "u p>agraph 7#a74  7,b7
 ,id5tification ,! ,adm9i/rator %all--  
7i7 id5tify any data & in=mation        
describ$ 9 subp>agraph 7,a7 on :i* !    
,adm9i/rator relies2  7ii7 describe !   
quality ( ! data & in=mation describ$ 9 
subp>agraph 7,a7 & ! ext5t to :i* ! data
 & in=mation dep>t f ^? crit]ia2  7iii7 
indicate any limitations on ! usefulness
 ( ! data & in=mation describ$ 9        
subp>agraph 7,a72 &  7iv7 expla9 h[ !   
data & in=mation describ$ 9 subp>agraph 

7,a7 0 us$ & ! basis = reliance on !    
data & in=mation4  7#e7 ,evaluative     
framework = decisionmak+  7,a7 ,9 g5]al 
,! ,adm9i/rator %all develop & use a    
/ructur$ evaluative framework consi/+ ( 
sci5ce-bas$ crit]ia1 consi/5t ) !       
protection ( human heal? & ! environm5t1
 = mak+ any decision "u ?is ,act1 & =   
det]m9+ ! relevance1 quality1 &         
reliability ( data & in=mation4  7,b7   
,cont5ts ,! framework describ$ 9        
subp>agraph 7,a7 %all1 at a m9imum--    
7i7 use s\nd & objective sci5tific      
practices 9 assess+ risks2  7ii7 consid]
 ! curr5t be/ available sci5ce 7includ+ 
pe]-review$ /udies72  7iii7 :5 consi/5t 
) ! und]ly+ data1 consid]1 = bo? canc] &
 noncanc] endpo9ts1 :e!r available data 
support or d n support ! id5tification (
 ?re%old doses ( a *emical sub/ance bel[
 :i* no adv]se effects c be expect$ to  
occur2 &  7iv7 include a description ( !
 weight ( ! sci5tific evid5ce conc]n+   
risks1 includ+ me*ani/ic in=mation 7su* 
z appropriate modes ( action74  7c7     

,data & in=mation s\rces ,9 mak+ any    
decision ) respect to a *emical sub/ance
 "u subsection 7e7 & sections #e & #f1 !
 ,adm9i/rator %all consid] data &       
in=mation relevant to ! sub/ance t are  
reasonably available to ! ,adm9i/rator  
at t "t1 includ+ data & in=mation t     
are--  7#a7 submitt$ to ! ,adm9i/rator  
by--  7,a7 manufactur]s & processors ( !
 sub/ance2  7,b7 ! public2 or  7,c7 a   
,gov]nor ( a ,/ate or a ,/ate ag5cy )   
responsibility = protect+ heal? or !    
environm5t2  7#b7 submitt$ to a         
gov]nm5tal body 9 ano!r jurisdiction "u 
a gov]nm5tal requirem5t relat+ to !     
protection ( human heal? & ! environm5t1
 if ! in=mation is accessible to !      
,adm9i/rator2  7#c7 d]iv$ ?r\gh !       
application ( sci5tifically reliable &  
relevant /ructure-activity relation%ip1 
or o!r me?ods or models to e/imate !    
environm5tal & human heal? effects1     
environm5tal & biological fate &        
behavior1 & exposure pot5tial = !       
sub/ance2  7#d7 inf]r$ bas$ on ! degree 

( /ructural simil>ity or prop]ties ( !  
sub/ance1 or categories ( sub/ances1 to 
^? ( #a or m o!r *emical sub/ances = :i*
 reliable in=mation exi/s t is relevant 
to pr$ict+ ! pot5tial environm5tal or   
human heal? effects1 environm5tal or    
biological fate & behavior1 or exposure 
pot5tial = ! *emical sub/ance2 &  7#e7  
id5tifi$ ?r\gh an active se>* by !      
,adm9i/rator ( in=mation s\rces t are   
publicly available or o!rwise accessible
 to ! ,adm9i/rator4  7d7 ,transp>5cy    
7#a7 ,9 g5]al ,subject to section #ad1 !
 data & in=mation consid]$ by !         
,adm9i/rator 9 tak+ action "u ?is ,act  
%all be available to ! public4  7#b7    
,types ( in=mation available to ! public
 ,! ,adm9i/rator %all make available to 
! public ! guidance1 proc$ures1 & tools 
us$ 9 evaluat+ data & in=mation "u ?is  
section1 includ+ models1 /udies1 &1 z   
appropriate1 ! data und]ly+ any /udy4   
7#c7 ,guidance ,any writt5 guidance (   
g5]al applicability prep>$ by !         
,adm9i/rator "u ?is ,act %all be subject

 to public notice & an opportunity =    
comm5t4  7e7 ,prioritization scre5+     
process  7#a7 ,9 g5]al  7,a7 ,process ,n
 lat] ?an #a ye> aft] ! date ( enactm5t 
( ! ,*emical ,safety ,improvem5t ,act1 !
 ,adm9i/rator %all e/abli% a risk-bas$  
scre5+ process = id5tify+ exi/+ *emical 
sub/ances t are--  7i7 a high priority =
 a safety assessm5t & det]m9ation "u    
section #f1 to be kn[n z high-priority  
sub/ances2 &  7ii7 a l[ priority = a    
safety assessm5t & det]m9ation1 to be   
kn[n z l[-priority sub/ances4  7,b7     
,consid]ation ( active & inactive       
sub/ances  7i7 ,consid]ation ( active   
sub/ances ,9 implem5t+ ! process        
describ$ 9 subp>agraph 7,a71 !          
,adm9i/rator %all only consid] active   
sub/ances1 z det]m9$ "u section         
#h7;b77#f71 z ei!r high-priority        
sub/ances or l[-priority sub/ances4     
7ii7 ,consid]ation ( inactive sub/ances 
,9 implem5t+ ! process describ$ 9       
subp>agraph 7,a71 ! ,adm9i/rator %all   
only consid] inactive sub/ances1 z      

det]m9$ "u section #h7;b77#g71 t !      
,adm9i/rator det]m9es1 on ! basis (     
cr$ible sci5tific evid5ce t--  7,i7 h n 
be5 subject to a regulatory or o!r      
en=ceable action by ! ,adm9i/rator to   
ban or phase out ! sub/ances2 &  7,,ii7 
demon/rate high haz>d & high exposure4  
7,c7 ,timely completion ( prioritization
 process  7i7 ,9 g5]al ,! ,adm9i/rator  
%all make e ef=t to complete !          
prioritization ( all active sub/ances 9 
a timely mann]4  7ii7 ,consid]ation ,!  
,adm9i/rator %all prioritize sub/ances  
tak+ into consid]ation ! ability ( !    
,adm9i/rator to s*$ule & complete safety
 assessm5ts & det]m9ations "u section #f
 9 a timely mann]4  7,d7 ,use ( data ,9 
mak+ a decision "u ! prioritization     
scre5+ process1 ! ,adm9i/rator %all use 
reasonably available data & in=mation   
conc]n+ ! haz>d1 exposure1 & use        
*>act]i/ics ( *emical sub/ances on ! li/
 develop$ by ! ,adm9i/rator "u section  
#h7;b77#a7 at ! "t ! decision is made4  
7,e7 ,scre5+ ( categories or classes (  

sub/ances ,! ,adm9i/rator may scre5     
categories or classes ( *emical         
sub/ances to ensure an effici5t         
prioritization scre5+ process to all[ = 
timely & adequate safety assessm5ts &   
det]m9ations4  7,f7 ,publication ( li/ (
 *emical sub/ances ,f "t to "t !        
,adm9i/rator %all--  7i7 publi% a li/ ( 
*emical sub/ances be+ consid]$ 9 !      
prioritization scre5+ process2 &  7ii7  
reque/ ! submission ( data & in=mation  
on ! *emical sub/ances4  7#b7 ,propos$  
process  7,a7 ,9 g5]al ,! ,adm9i/rator  
%all--  7i7 publi% = public comm5t a    
propos$ prioritization scre5+ process2 &
  7ii7 e/abli% crit]ia = det]m9+ :e!r a 
sub/ance is a high or l[ priority = a   
safety assessm5t & det]m9ation4  7,b7   
,initial li/  7i7 ,9 g5]al ,! proposal  
%all include an initial li/ ( *emical   
sub/ances t includes1 at a m9imum1 ^?   
sub/ances prioritiz$ by ! ,adm9i/rator  
be=e ! date ( enactm5t ( ! ,*emical     
,safety ,improvem5t ,act & = :i*        
assessm5ts or safety det]m9ations h n   

be5 complet$1 & propos$ prioritization  
outcomes bas$ on ! propos$ crit]ia4     
7ii7 ,cont5ts ,! initial li/ %all conta9
 z _m *emical sub/ances z ! ,adm9i/rator
 det]m9es appropriate4  7iii7           
,modification ,! ,adm9i/rator may modify
 ! initial li/ on ! basis ( comm5ts     
receiv$ on ! propos$ process & crit]ia4 
7,c7 ,crit]ia ,! crit]ia describ$ 9     
subp>agraph 7,a7 %all consid]--  7i7 !  
recomm5dation ( a ,gov]nor ( a ,/ate or 
a ,/ate ag5cy ) responsibility =        
protect+ heal? or ! environm5t f *emical
 sub/ances appropriate = prioritization 
scre5+2  7ii7 ! haz>d & exposure        
pot5tial ( ! *emical sub/ance 7or       
category or class ( sub/ances71 includ+ 
specific sci5tific classifications &    
designations by au?oritative gov]nm5tal 
entities2  7iii7 ! int5d$ conditions (  
use or significant *anges 9 ! conditions
 ( use ( ! *emical sub/ance2  7iv7      
evid5ce & indicators ( exposure pot5tial
 to humans or ! environm5t f ! *emical  
sub/ance2  7v7 ! volume ( a *emical     

sub/ance manufactur$ or process$2  7vi7 
:e!r ! volume ( a *emical sub/ance z    
report$ "u a regulation issu$ "u section
 #h7;a7 7z 9 effect on ! date on :i* !  
crit]ia are propos$7 has significantly  
increas$ or decreas$ s9ce a previ\s     
report or s9ce ! date on :i* a notice   
has be5 submitt$ "u section #e7;a72     
7vii7 ! availability ( in=mation ab\t   
pot5tial haz>ds & exposures ne$$ =      
conduct+ a safety assessm5t or          
det]m9ation1 ) limit$ availability (    
relevant data & in=mation to be a factor
 9 designat+ a sub/ance z a high        
priority2 &  7viii7 ! ext5t ( ,f$]al or 
,/ate regulation ( ! *emical sub/ance or
 ! ext5t ( ! impact ( ,/ate regulation (
 ! *emical sub/ance on ! ,unit$ ,/ates1 
) exi/+ ,f$]al or ,/ate regulation ( any
 uses evaluat$ 9 ! prioritization scre5+
 process z a factor 9 designat+ a       
*emical sub/ance to be a l[ priority4   
7#c7 ,prioritization scre5+ decisions   
7,a7 ,9 g5]al ,= ! *emical sub/ances    
consid]$ = prioritization scre5+1 !     

,adm9i/rator %all apply ! crit]ia       
id5tifi$ 9 p>agraph 7#b71 us+ !         
in=mation id5tifi$ 9 subsection 7c71 to 
id5tify a *emical sub/ance z a          
high-priority sub/ance or a l[-priority 
sub/ance4  7,b7 ,additional te/ data ,if
 ! ,adm9i/rator det]m9es t additional   
te/ data & in=mation are ne$$ to e/abli%
 ! priority ( a *emical sub/ance1 !     
,adm9i/rator %all provide an opportunity
 = int]e/$ p]sons to submit data &      
in=mation to ! ext5t t x is reasonably  
asc]ta9able4  7,c7 ,def]r+ a decision   
,if ! ,adm9i/rator det]m9es t x is      
appropriate1 ! ,adm9i/rator may def] a  
prioritization scre5+ decision = a      
*emical sub/ance "u subp>agraph 7,a7 = a
 reasonable p]iod to all[ = ! submission
 & evaluation ( additional data &       
in=mation4  7,d7 ,integration ( data &  
in=mation ,dur+ ! prioritization scre5+ 
( a *emical sub/ance1 ! ,adm9i/rator    
%all integrate any haz>d & exposure data
 & in=mation relat$ to a *emical        
sub/ance available to ! ,adm9i/rator4   

7,e7 ,id5tification ( high-priority     
sub/ances ,! ,adm9i/rator--  7i7 %all   
id5tify z a high-priority sub/ance a    
*emical sub/ance t1 relative to o!r     
sub/ances1 has ! pot5tial = high haz>d &
 high exposure2  7ii7 may id5tify z a   
high-priority sub/ance a *emical        
sub/ance t1 relative to o!r sub/ances1  
has ! pot5tial = high haz>d or high     
exposure2 &  7iii7 may id5tify z a      
high-priority sub/ance an inactive      
sub/ance1 z det]m9$ "u section          
#h7;b77#g71 t ! ,adm9i/rator det]m9es1  
on ! basis ( cr$ible sci5tific evid5ce  
t--  7,i7 has n be5 subject to a        
regulatory action by ! ,adm9i/rator to  
ban or phase out ! sub/ance2 &  7,,ii7  
demon/rates high haz>d & high exposure4 
7,f7 ,id5tification ( l[-priority       
sub/ances ,! ,adm9i/rator %all id5tify z
 a l[-priority sub/ance a *emical       
sub/ance t ! ,adm9i/rator on ! basis ( !
 available in=mation det]m9es is likely 
to meet ! safety /&>d "u ! int5d$       
conditions ( use4  7,g7 ,notice & comm5t

 ,! id5tifications made "u subp>agraphs 
7,e7 & 7,f7 %all be subject to notice & 
an opportunity = comm5t4  7,h7 ,ord] (  
safety assessm5ts  7i7 ,high-priority   
sub/ances ,! ,adm9i/rator--  7,i7 %all  
det]m9e ! ord] = p]=m+ safety assessm5ts
 on high-priority sub/ances "u section  
#f2 &  7,,ii7 may revise ! ord] z !     
,adm9i/rator det]m9es appropriate4  7ii7
 ,l[-priority sub/ance ,! ,adm9i/rator  
%all n p]=m safety assessm5ts on        
l[-priority sub/ances1 unless a         
l[-priority sub/ance is r$esignat$ "u   
subp>agraph 7,i74  7,i7 ,revision bas$  
on new data  7i7 ,9 g5]al ,subject to   
subp>agraph 7,d71 at any "t !           
,adm9i/rator may revise ! id5tification 
( a *emical sub/ance z a high-priority  
sub/ance or a l[-priority sub/ance bas$ 
on consid]ation ( data or in=mation made
 available to ! ,adm9i/rator aft] ! date
 on :i* ! ,adm9i/rator makes !          
id5tification "u subp>agraphs 7,e7 &    
7,f74  7ii7 ,reevaluation  7,i7 ,9 g5]al
 ,! ,adm9i/rator %all evaluate ! data or

 in=mation describ$ 9 clause 7i7 on a   
high-priority sub/ance or a l[-priority 
sub/ance = possible reevaluation ( !    
priority ( ! sub/ance4  7,,ii7 ,limit$  
availability ,if limit$ availability (  
relevant data & in=mation 0 a factor 9 !
 orig9al id5tification ( a *emical      
sub/ance z a high-priority sub/ance1 !  
,adm9i/rator %all reevaluate !          
prioritization scre5+ ( ! sub/ance on   
receiv+ ! relevant data & in=mation4    
7,j7 ,publication ( a li/ (             
high-priority & l[-priority sub/ances   
7i7 ,9 g5]al ,! ,adm9i/rator %all publi%
 & keep curr5t a li/ ( high-priority    
sub/ances & a li/ ( l[-priority         
sub/ances4  7ii7 ,ju/ification ,:5ev] ! 
,adm9i/rator places a *emical sub/ance  
on "o ( ! li/s describ$ 9 clause 7i7 or 
*anges ! priority ( ! *emical sub/ance1 
! ,adm9i/rator %all include a           
ju/ification = ! decision 9 accordance )
 p>agraph 7#b77;,c74  7,k7 ,removal ,!  
,adm9i/rator %all remove a *emical      
sub/ance f ! li/ ( high-priority        

sub/ances on ! date on :i* a safety     
det]m9ation = ! *emical sub/ance is     
publi%$4  7,l7 ,effect ,subject to      
section #ah1 a decision by !            
,adm9i/rator "u ?is p>agraph ) respect  
to a *emical sub/ance %all n affect !   
manufacture1 process+1 di/ribution1 use1
 or disposal ( ! *emical sub/ance1 or   
regulation ( ^? activities4  7#d7       
,exp$it$ prioritization scre5+  7,a7 ,9 
g5]al ,n lat] ?an #ahj days aft] ! date 
on :i* ! ,adm9i/rator receives a        
recomm5dation & relevant data &         
in=mation f a ,gov]nor ( a ,/ate or a   
,/ate ag5cy ) responsibility = protect+ 
heal? & ! environm5t t an active *emical
 sub/ance be id5tifi$ z a high-priority 
or l[-priority sub/ance1 ! ,adm9i/rator 
%all make a prioritization scre5+       
decision = ! sub/ance4  7,b7 ,notice &  
comm5t ,! public %all be provid$ notice 
& an opportunity to comm5t on !         
recomm5dation describ$ 9 subp>agraph    
7,a74  7,c7 ,explanation ( reasons ,!   
,adm9i/rator %all--  7i7 make available 

to ! ,gov]nor or ! appropriate ,/ate    
ag5cy1 z applicable1 & to ! public a    
brief explanation ( reasons = id5tify+ a
 *emical sub/ance recomm5d$ by !        
,gov]nor or ! ag5cy = prioritization    
scre5+ z ei!r a high-priority sub/ance  
or a l[-priority sub/ance2 &  7ii7      
id5tify ! in=mation reli$ ^u 9 mak+ t   
id5tification4  7#e7 ,f9al ag5cy action 
,any action by ! ,adm9i/rator "u ?is    
subsection %all n be--  7,a7 consid]$ to
 be a f9al ag5cy action2 or  7,b7       
subject to judicial review4  7f7        
,developm5t ( new te/ data & in=mation  
7#a7 ,9 g5]al ,! ,adm9i/rator may       
require ! developm5t ( new te/ data &   
in=mation relat$ to a *emical sub/ance  
or mixture 9 accordance ) ?is section if
 ! ,adm9i/ration det]m9es t ! data &    
in=mation are ne$$--  7,a7 to p]=m a    
safety assessm5t2  7,b7 to make a safety
 det]m9ation2 or  7,c7 to meet ! te/+   
ne$s ( ! implem5t+ au?ority "u ano!r    
,f$]al /atute4  7#b7 ,=m ,! ,adm9i/rator
 may require ! developm5t ( te/ data &  

in=mation describ$ 9 p>agraph 7#a7 by-- 
7,a7 promulgat+ a rule2  7,b7 ent]+ into
 a te/+ cons5t agreem5t2 or  7,c7 issu+ 
an ord]4  7#c7 ,requirem5ts  7,a7 ,9    
g5]al ,9 promulgat+ a rule1 adopt+ a    
te/+ cons5t agreem5t1 or issu+ an ord]  
describ$ 9 p>agraph 7#b71 ! ,adm9i/rator
 %all require ! use (--  7i7 an         
evaluation framework t1 prior to requir+
 additional te/+ ( v]tebrate animals1   
integrates relevant in=mation f multiple
 s\rces1 includ+1 to ! ext5t reliable-- 
7,i7 toxicity in=mation2  7,,ii7        
computational toxicology2  7,,iii7      
bio9=matics2  7,,iv7 high-?r\ghput      
scre5+ me?ods2 &  7,v7 sci5tifically    
reliable & relevant alt]natives to      
v]tebrate animal te/s2 &  7ii7 ti]$ te/+
 9 accordance ) subsection 7h71 :]e9 !  
results ( a scre5+ level ti] ( te/s     
relat+ to a toxicity pa?way or t>get    
organ or t>get sy/em in=m ! decision ( !
 ,adm9i/rator z to :e!r te/s f a high]  
ti] relat$ to t pa?way or organ or sy/em
 are necess>y4  7,b7 ,/atem5t to !      

public ,! ,adm9i/rator %all expla9 !    
basis = a decision made 9 subp>agraph   
7,a77ii7 9 a /atem5t made available to !
 public4  7#d7 ,cont5ts  7,a7 ,9 g5]al  
,a rule1 te/+ cons5t agreem5t1 or ord]  
issu$ "u p>agraph 7#b7 %all include--   
7i7 id5tification ( ! *emical sub/ance  
or mixture = :i* te/+ is requir$2  7ii7 
id5tification ( ! p]sons requir$ to     
conduct ! te/+2  7iii7 proc$ures = !    
developm5t ( te/ data & in=mation = !   
*emical sub/ance or mixture1 includ+    
specific ref]5ce to reliable nonanimal  
te/ proc$ures2 &  7iv7 specification ( !
 p]iod )9 :i* p]sons requir$ to conduct 
! te/+ %all submit to ! ,adm9i/rator te/
 data & in=mation develop$ 9 accordance 
) ! proc$ures describ$ 9 clause 7iii74  
7,b7 ,duration ,! p]iod describ$ 9      
subp>agraph 7,a77iv7 %all n be ( an     
unreasonable duration4  7,c7            
,consid]ations ,9 det]m9+ ! proc$ures & 
p]iod to be requir$ "u subp>agraph 7,a71
 ! ,adm9i/rator %all consid]--  7i7 !   
relative co/s ( ! v>i\s te/ protocols & 

me?odologies t may be requir$2 &  7ii7 !
 reasonably =eseeable availability (    
facilities & p]sonnel ne$$ to p]=m !    
te/+4  7g7 ,/atem5t ( ne$  7#a7 ,9 g5]al
 ,9 promulgat+ a rule1 ent]+ into a te/+
 cons5t agreem5t1 or issu+ an ord] =    
developm5t ( additional data & in=mation
 7includ+ in=mation on exposure or      
exposure pot5tial7 "u subsection        
7f77#b71 ! ,adm9i/rator %all issue a    
/atem5t--  7,a7 id5tify+ ! ne$ int5d$ to
 be met by ! rule1 agreem5t1 or ord]2   
7,b7 expla9+ :y exi/+ data & in=mation  
reasonably available to ! ,adm9i/rator  
at t "t are inadequate to meet t ne$2 & 
7,c7 enc\rag+1 to ! ext5t possible1 !   
use ( nonanimal te/ me?ods to develop   
additional data & in=mation4  7#b7      
,cont5ts ( /atem5t 9 case ( ord]  7,a7  
,9 g5]al ,if ! ,adm9i/rator issues an   
ord]1 ! /atem5t describ$ 9 p>agraph 7#a7
 %all expla9 :y good cause exi/s =      
issuance ( an ord] in/ead ( promulgat+ a
 rule or ent]+ into a te/+ cons5t       
agreem5t4  7,b7 ,cont5ts ,a /atem5t     

describ$ 9 subp>agraph 7,a7 %all conta9 
a discussion (--  7i7 data & in=mation t
 are readily accessible to !            
,adm9i/rator1 includ+ data & in=mation  
submitt$ "u any o!r provision ( law2    
7ii7 ! ext5t to :i* ! ,adm9i/rator has  
obta9$ or attempt$ to obta9 ! data &    
in=mation ?r\gh volunt>y submissions2   
7iii7 ! ext5t to :i* ! ,adm9i/rator may 
use available data & in=mation =        
/ructurally relat$ sub/ances 7gr\p+ or  
read-across71 or use valid              
/ructure-activity relation%ip models or 
nonanimal te/ alt]natives2 &  7iv7      
safety assessm5ts1 & ! data & in=mation 
reli$ on 9 ! assessm5ts1 on o!r *emical 
sub/ances to ! ext5t relevant to !      
*emical sub/ances t w\ld be ! subject ( 
! rule or ord]4  7h7 ,ti]$ toxicity te/+
 & evaluation  7#a7 ,9 g5]al ,!         
,adm9i/rator %all develop an            
evid5ce-bas$ review sy/em = conduct+    
consi/5t evaluations ( ! relevance &    
reliability ( /udies ( *emical sub/ances
 & _! exposure 7includ+ exposure        

pa?ways71 & a /ructur$ evaluative       
framework to provide a sy/ematic &      
transp>5t approa* = assess+ ! ov]all    
weight ( ! evid5ce = obs]v$ biological  
or o!r effects1 me*ani/ic in=mation1 &  
exposure4  7#b7 ,ti]s ,subject to       
subsections 7b7 & 7c71 ! framework %all 
h #b ti]s4  7,a7 ,ti] #a  7i7 ,9 g5]al  
,ti] #a %all include bo? a scre5+ level 
exposure assessm5t1 includ+ model+ if   
appropriate1 & scre5+ te/s = haz>d4     
7ii7 ,uses ( scre5+ te/s & model+       
,scre5+ te/s = haz>d 7:i* may include1 z
 appropriate1 sci5tifically reliable &  
relevant 9 silico1 9 vitro1 & focus$ 9  
vivo te/s7 & exposure in=mation & model+
 %all be us$--  7,i7 to scre5 *emical   
sub/ances or mixtures = major toxic     
effects 7includ+ acute toxicity1        
sub*ronic toxicity1 *ronic toxicity1    
c>c9og5icity1 g5otoxicity1 developm5tal 
toxicity1 & neurotoxicity72 &  7,,ii7 to
 direct plann+ = m complex & t>get$ te/+
 9 ti] #b1 if necess>y4  7,b7 ,ti] #b   
,if ! ,adm9i/rator det]m9es t additional

 te/+ is necess>y1 bas$ on ! results (  
ti] #a te/+ & model+ & any o!r available
 relevant in=mation1 ti] #b %all        
include--  7i7 an exposure assessm5t &  
te/s = specific endpo9ts trigg]$ on !   
basis ( biologically bas$ decisions2 &  
7ii7 an assessm5t ( pot5tial exposure   
us+ sci5tifically valid approa*es4  7#c7
 ,guidance ,! ,adm9i/rator %all prep>e  
guidance = implem5t+ ?is subsection &   
review t guidance n less ?an once e #e  
ye>s !reaft]4  7i7 ,r$uction (          
animal-,bas$ te/+  7#a7 ,9 g5]al ,!     
,adm9i/rator %all m9imize ! use (       
animals 9 te/+ ( *emical sub/ances or   
mixtures1 includ+ by--  7,a7 enc\rag+ & 
facilitat+1 to ! maximum ext5t          
practicable--  7i7 ! use ( integrat$ &  
ti]$ te/+ & assessm5t /rategies2  7ii7 !
 use ( data & in=mation ( suffici5t     
sci5tific quality 9 exi/5ce on ! date on
 :i* ! te/ is conduct$2  7iii7 ! use (  
te/ me?ods t elim9ate or r$uce ! use (  
animals :ile provid+ te/ data &         
in=mation ( high sci5tific quality2     

7iv7 ! gr\p+ ( #b or m *emical sub/ances
 into sci5tifically appropriate         
categories 9 cases 9 :i* te/+ ( a       
*emical sub/ance w\ld provide reliable &
 useful te/ data & in=mation on o!rs 9 !
 category2  7v7 ! =mation ( indu/ry     
consortia to jo9tly conduct te/+ to     
avoid unnecess>y duplication ( te/s2    
7vi7 ! submission ( te/ data & in=mation
 f animal-bas$ /udies & f em]g+ me?ods &
 models2 &  7vii7 ! use ( exposure      
pot5tial z a factor 9 decisions to      
require new te/+2 &  7,b7 fund+ rese>* &
 validation /udies to r$uce1 ref9e1 &   
replace ! use ( animal te/s 9 accordance
 ) ?is subsection4  7#b7 ,implem5tation 
( alt]native te/+ me?ods ,to promote !  
developm5t & timely incorporation ( new 
te/+ me?ods t are n laboratory          
animal-bas$1 ! ,adm9i/rator %all--  7,a7
 aft] provid+ an opportunity = public   
comm5t1 develop a /rategic plan to      
promote ! developm5t & implem5tation (  
alt]native te/ me?ods & te/+ /rategies  
to g5]ate in=mation us$ = any           

safety-/&>d det]m9ation made t r$uce1   
ref9e1 or replace ! use ( laboratory    
animals1 includ+ toxicity pa?way-bas$   
risk assessm5t1 9 vitro /udies1 sy/ems  
biology1 computational toxicology1      
bio9=matics1 & high-?r\ghput scre5+2    
7,b7 beg9n+ on ! date t is #e ye>s aft] 
! date ( enactm5t ( ! ,*emical ,safety  
,improvem5t ,act & e #e ye>s !reaft]1   
submit to ,congress a report t describes
 ! progress made 9 implem5t+ ?is        
section2 &  7,c7 fund & c>ry out rese>*1
 developm5t1 p]=mance assessm5t1 &      
translational /udies to accel]ate !     
developm5t ( te/ me?ods & te/+ /rategies
 t r$uce1 ref9e1 or replace ! use (     
laboratory animals 9 any safety-/&>d    
det]m9ation made "u ?is section4  7#c7  
,crit]ia = adapt+ or waiv+ animal te/+  
requirem5ts ,on reque/ f a manufactur]  
or processor t is requir$ to conduct    
animal-bas$ te/+ ( a *emical sub/ance or
 mixture "u ?is title1 ! ,adm9i/rator   
may adapt or waive ! animal-te/+        
requirem5t if ! ,adm9i/rator det]m9es   

t--  7,a7 !re is suffici5t evid5ce f    
sev]al indep5d5t s\rces ( in=mation to  
support a conclusion t a *emical        
sub/ance or mixture has1 or does n h1 a 
p>ticul> prop]ty if ! in=mation f ea*   
individual s\rce alone is insuffici5t to
 support ! conclusion2  7,b7 because (  
"o or m physical or *emical prop]ties ( 
! *emical sub/ance or mixture or o!r    
toxicok9etic consid]ations--  7i7 !     
mat]ial _c be absorb$2 or  7ii7 te/+ = a
 specific endpo9t is te*nically n       
practicable to conduct2 or  7,c7 a      
*emical sub/ance or mixture _c be te/$ 9
 animals at conc5trations t d n result 9
 significant pa9 or di/ress1 because (  
physical or *emical prop]ties ( !       
*emical sub/ance or mixture1 su* z a    
pot5tial to cause sev]e corrosion or    
sev]e irritation to ! tissues ( !       
animal4  7j7 ,te/+ requirem5ts  7#a7    
,p]sons requir$ to develop te/ data &   
in=mation  7,a7 ,9 g5]al ,! ,adm9i/rator
 may require ! foll[+ p]sons to develop 
te/ data & in=mation3  7i7 ,manufactur]s

 & processors ( ! *emical sub/ance or   
mixture id5tifi$ 9 subsection           
7f77#d77;,a77i74  7ii7 ,p]sons :o beg9  
to manufacture or process su* *emical   
sub/ance or mixture--  7,i7 aft] !      
effective date ( ! rule1 te/+ cons5t    
agreem5t1 or ord]2 b  7,,ii7 subject to 
subp>agraph 7,c71 be=e ! p]iod end+ #ahj
 days aft] ! end ( ! p]iod id5tifi$ 9   
subsection 7f77#d77;,a77iv74  7,b7      
,designation ,! ,adm9i/rator may p]mit  
#b or m ( ! p]sons id5tifi$ 9           
subp>agraph 7,a7 to designate a p]son or
 a qualifi$ ?ird p>ty--  7i7 to develop 
! data & in=mation2 &  7ii7 to submit ! 
data & in=mation on behalf ( ! p]sons   
mak+ ! designation4  7,c7 ,exemptions   
7i7 ,9 g5]al ,a p]son o!rwise subject to
 a rule1 te/+ cons5t agreem5t1 or ord]  
"u subsection 7f7 may submit to !       
,adm9i/rator an application = an        
exemption on ! basis t ! data &         
in=mation are be+ develop$ by a p]son   
designat$ "u subp>agraph 7,b74  7ii7    
,fair & equitable reimbursem5t to       

designee  7,i7 ,9 g5]al ,if !           
,adm9i/rator accepts an application     
submitt$ "u clause 7i71 ! ,adm9i/rator  
%all direct ! applicant to provide to ! 
p]son designat$ "u subp>agraph 7,b7 fair
 & equitable reimbursem5t1 z agre$ to   
betwe5 ! applicant & ! p]son designat$4 
7,,ii7 ,arbitration ,if ! applicant & a 
p]son designat$ "u subp>agraph 7,b7 _c  
rea* agreem5t on ! am\nt ( fair &       
equitable reimbursem5t1 ! am\nt %all be 
det]m9$ by arbitration4  7iii7          
,t]m9ation ,if1 aft] grant+ an exemption
 "u ?is subp>agraph1 ! ,adm9i/rator     
det]m9es t no p]son has compli$ ) !     
rule1 te/+ cons5t agreem5t1 or ord]1 !  
,adm9i/rator %all--  7,i7 by ord]       
t]m9ate ! exemption2 &  7,,ii7 notify 9 
writ+ ea* p]son :o receiv$ an exemption 
( ! requirem5ts ) respect to :i* !      
exemption 0 grant$4  7#b7 ,types ( heal?
 & environm5tal data & in=mation  7,a7  
,9 g5]al ,! ,adm9i/rator may prescribe  
guidel9es = ! developm5t ( te/ data &   
in=mation "u subsection 7f7 = heal? &   

environm5tal in=mation1 includ+--  7i7  
te/ data p]ta9+ to acute toxicity1      
sub*ronic toxicity1 *ronic toxicity1    
c>c9og5icity1 g5otoxicity1 developm5tal 
toxicity1 & neurotoxicity t may be      
indicative ( an adv]se effect2  7ii7 te/
 data & in=mation p]ta9+ to exposure to 
! *emical sub/ance or mixture1 includ+  
in=mation reg>d+ bioaccumulation1       
p]si/5ce1 & ! pres5ce ( ! *emical       
sub/ance or mixture 9 human blood1      
fluids1 or tissue2 &  7iii7 in=mation   
p]ta9+ to aggregate exposure1 or o!r    
effects t may be consid]$ 9 a safety    
assessm5t4  7,b7 ,me?odologies  7i7 ,9  
g5]al ,! ,adm9i/rator--  7,i7 may       
prescribe me?odologies 9 guidel9es = !  
developm5t ( data & in=mation2 &  7,,ii7
 %all enc\rage ! use ( nonanimal        
me?odologies4  7ii7 ,developm5t (       
guidel9es ,! ,adm9i/rator may develop   
guidel9es = evaluat+ data f biomonitor+ 
/udies4  7iii7 ,requirem5t ,prior to    
prescrib+ epidemiologic /udies (        
employees1 ! ,adm9i/rator %all coord9ate

 ) ! ,director ( ! ,national ,in/itute =
 ,occupational ,safety & ,heal?4  7,c7  
,review ,p]iodically1 b n less frequ5tly
 ?an once e #e ye>s1 ! ,adm9i/rator     
%all--  7i7 review ! adequacy ( !       
guidel9es = developm5t ( data &         
in=mation prescrib$ "u subp>agraph 7,b72
  7ii7 if necess>y1 in/itute proce$+s to
 make appropriate revisions ( !         
guidel9es2 &  7iii7 revise ! guidel9es z
 appropriate1 p>ticul>ly to--  7,i7     
reflect ! availability ( sci5tifically  
reliable & relevant nonanimal te/       
me?ods2 &  7,,ii7 elim9ate obsolete     
me?odologies t d n produce reliable &   
relevant results4  7k7 ,transp>5cy      
,subject to section #ad1 ! ,adm9i/rator 
%all make available to ! public all te/+
 cons5t agreem5ts & ord]s & all data &  
in=mation submitt$ "u ?is section4  4   
7b7 ,con=m+ am5dm5ts ,section           
#ajd7;i77#e77;,a7 ( ! ,compreh5sive     
,environm5tal ,response1 ,comp5sation1 &
 ,liability ,act ( #aihj 7#db ,u4,s4,c4 
#ifjd7;i77#e77;,a77 is am5d$ by /rik+   

section #d7;e7 & ins]t+ section #d7l74  
#e4 ,new *emicals & significant new uses
 ,section #e 7#ae ,u4,s4,c4 #bfjd7 is   
am5d$--  7#a7 by /rik+ ! section        
designation & head+ & ins]t+ ! foll[+3  
#e4 ,new *emicals & significant new uses
  2  7#b7 9 subsection 7a77#a71 9 !     
matt] foll[+ subp>agraph 7,b7--  7,a7 by
 /rik+ subsection 7d7 & ins]t+          
subsection 7b72 &  7,b7 by /rik+ & su*  
p]son complies ) any applicable         
requirem5t ( subsection 7b72  7#c7 by   
/rik+ subsection 7b72  7#d7 by          
r$esignat+ subsection 7d7 z subsection  
7b7 & mov+ ! subsection s z to appe>    
aft] subsection 7a72  7#e7 9 subsection 
7b7 7z s r$esignat$7--  7,a7 by /rik+   
p>agraph 7#a7 & ins]t+ ! foll[+3  7#a7  
,9 g5]al ,! notice requir$ by subsection
 7a7 %all include1 ) respect to a       
*emical sub/ance--  7,a7 ! in=mation    
requir$ by sections #gbj4de & #gbj4ej ( 
title #dj1 ,code ( ,f$]al ,regulations  
7or successor regulations72 &  7,b7     
in=mation reg>d+ int5d$ conditions ( use

 & reasonably anticipat$ exposure4  2   
7,b7 9 p>agraph 7#b7--  7i7 9 ! matt]   
prec$+ subp>agraph 7,a71 by /rik+ or (  
data "u subsection 7b72  7ii7 9         
subp>agraph 7,a71 by add+ & aft] !      
semicolon at ! end2  7iii7 9 subp>agraph
 7,b71 by /rik+ 2 & & ins]t+ a p]iod2 & 
7iv7 by /rik+ subp>agraph 7,c72 &  7,c7 
9 p>agraph 7#c71 by /rik+ 1 7b712  7#f7 
by /rik+ subsection 7c7 & ins]t+ !      
foll[+3  7c7 ,review ( notice  7#a7     
,initial review  7,a7 ,9 g5]al ,subject 
to subp>agraph 7,b71 n lat] ?an #ij days
 aft] ! date ( receipt ( a notice       
submitt$ "u subsection 7a71 !           
,adm9i/rator %all--  7i7 conduct an     
initial review ( ! notice2  7ii7 z ne$$1
 develop a pr(ile ( ! relevant *emical  
sub/ance & ! pot5tial = exposure to     
humans & ! environm5t2 &  7iii7 make any
 necess>y det]m9ation "u p>agraph 7#d74 
7,b7 ,ext5sion ,except z provid$ 9      
p>agraph 7#f71 ! ,adm9i/rator may ext5d 
! p]iod describ$ 9 subp>agraph 7,a7 =   
good cause = "o or m p]iods1 ! total (  

:i* %all be n m ?an #ij days4  7#b7     
,notice ( comm5cem5t ,unless !          
,adm9i/rator det]m9es "u p>agraph       
7#d77;,a7 t a *emical sub/ance is n     
likely to meet ! safety /&>d1 at ! end (
 ! applicable p]iod = review "u p>agraph
 7#a71 a *emical sub/ance may be !      
subject ( a notice ( comm5cem5t "u      
subsection 7d74  7#c7 ,in=mation s\rces 
,9 evaluat+ a notice "u p>agraph 7#a71 !
 ,adm9i/rator %all take into            
consid]ation--  7,a7 ! in=mation        
id5tifi$ 9 section #d7;c72 &  7,b7 any  
additional in=mation provid$ by !       
submitt]4  7#d7 ,det]m9ations ,be=e !   
end ( ! applicable p]iod = review "u    
p>agraph 7#a71 bas$ on ! in=mation      
describ$ 9 p>agraph 7#c71 ! ,adm9i/rator
 %all det]m9e t--  7,a7 ! relevant      
*emical sub/ance is n likely to meet !  
safety /&>d "u ! int5d$ conditions (    
use1 9 :i* case ! ,adm9i/rator %all take
 appropriate action "u p>agraph 7#e72   
7,b7 ! relevant *emical sub/ance is     
likely to meet ! safety /&>d "u ! int5d$

 conditions ( use1 9 :i* case !         
,adm9i/rator %all all[ ! review p]iod to
 expire )\t additional re/rictions2 or  
7,c7 additional in=mation is necess>y 9 
ord] to make a det]m9ation "u           
subp>agraph 7,a7 or 7,b71 9 :i* case !  
,adm9i/rator %all take appropriate      
action "u p>agraph 7#f74  7#e7          
,prohibitions & limitations  7,a7 ,9    
g5]al ,if ! ,adm9i/rator makes a        
det]m9ation "u p>agraph 7#d77;,a7 )     
respect to a notice1 be=e ! end ( !     
applicable p]iod = review "u p>agraph   
7#a71 ! ,adm9i/rator %all1 by cons5t    
agreem5t or ord]1 z appropriate--  7i7  
prohibit manufacture ( ! *emical        
sub/ance1 or prohibit su* manufacture   
)\t compliance ) re/rictions specifi$ 9 
a relevant cons5t agreem5t or ord]2 or  
7ii7 prohibit manufacture or process+ ( 
! *emical sub/ance = a significant new  
use1 or prohibit su* manufacture or     
process+ )\t compliance ) re/rictions   
specifi$ 9 a relevant cons5t agreem5t or
 ord]4  7,b7 ,inclusions ,a prohibition 

or limitation "u subp>agraph 7,a7 may   
include1 z appropriate--  7i7 a         
requirem5t t a *emical sub/ance be m>k$ 
)1 or accompani$ by1 cle> & adequate    
w>n+s & in/ructions ) respect to use1   
di/ribution 9 comm]ce1 or disposal1 or  
any comb9ation ( ^? activities1 ) ! =m &
 cont5t ( ! w>n+s & in/ructions to be   
prescrib$ by ! ,adm9i/rator2  7ii7 a    
requirem5t t manufactur]s or processors1
 z applicable1 ( ! *emical sub/ance make
 & reta9 records ( ! processes us$ to   
manufacture or process ! *emical        
sub/ance2  7iii7 a requirem5t t         
manufactur]s or processors1 z           
applicable1 monitor or conduct su*      
additional te/s z are reasonably        
necess>y to ensure compliance ) ?is     
,act1 subject to section #d7;g72  7iv7 a
 limitation on ! quantity ( ! *emical   
sub/ance t may be manufactur$1 process$1
 or di/ribut$ 9 comm]ce2  7v7 a         
limitation on ! quantity ( ! *emical    
sub/ance t may be manufactur$1 process$1
 or di/ribut$ 9 comm]ce = a p>ticul>    

use2  7vi7 a prohibition or o!r         
regulation ( ! manufacture1 process+1 or
 di/ribution 9 comm]ce ( ! *emical      
sub/ance = a significant new use2  7vii7
 a prohibition or o!r regulation ( any  
me?od ( comm]cial use ( ! *emical       
sub/ance2  7viii7 a prohibition or o!r  
regulation ( any me?od ( disposal ( !   
*emical sub/ance2  7ix7 a prohibition on
 ! manufacture1 process+1 or di/ribution
 9 comm]ce ( ! *emical sub/ance2  7x7 a 
prohibition on ! manufacture1 process+1 
or di/ribution 9 comm]ce ( ! *emical    
sub/ance = a p>ticul> use2 or  7xi7 su* 
o!r requirem5ts z ! ,adm9i/rator        
det]m9es to be necess>y4  7#f7          
,additional data & in=mation ,if !      
,adm9i/rator det]m9es "u p>agraph       
7#d77;,c7 t additional data & in=mation 
7includ+1 = example1 in=mation on       
exposure or exposure pot5tial7 are ne$$ 
9 ord] to conduct a review "u ?is       
subsection1 ! ,adm9i/rator--  7,a7 %all 
provide an opportunity = ! submitt] ( ! 
notice to submit su* additional         

in=mation2  7,b7 may1 by agreem5t ) !   
submitt]1 ext5d ! review p]iod = a      
reasonable "t to all[ ! developm5t &    
submission ( ! additional in=mation2    
7,c7 on receipt ( ! in=mation1 %all     
promptly make a det]m9ation "u p>agraph 
7#d72 &  7,d7 may take action "u        
p>agraph 7#e7 p5d+ receipt ( !          
additional data & in=mation1 :i* may1 z 
appropriate1 p]mit ! submitt] ( ! notice
 to file a notice ( comm5cem5t "u       
subsection 7d74  2  7#g7 by /rik+       
subsections 7e7 ?r\gh 7g7 & ins]t+ !    
foll[+3  7d7 ,notice ( comm5cem5t  7#a7 
,9 g5]al ,n lat] ?an #cj days aft] !    
date on :i* a manufactur] or processor t
 has submitt$ a notice "u subsection 7a7
 comm5ces nonexempt comm]cial           
manufacture ( a *emical sub/ance or     
nonexempt comm]cial manufacture or      
process+ ( a *emical sub/ance = a       
significant new use1 z applicable1 !    
manufactur] or processor %all submit to 
! ,adm9i/rator a notice ( comm5cem5t t  
id5tifies--  7,a7 ! "n ( ! manufactur]  

or processor2 &  7,b7 ! initial date (  
nonexempt comm]cial manufacture or      
nonexempt comm]cial manufacture or      
process+ = a significant new use4  7#b7 
,)drawal ,a manufactur] or processor t  
has submitt$ a notice "u subsection 7a71
 b t has n comm5c$ nonexempt comm]cial  
manufacture or process+ ( ! *emical     
sub/ance1 may )draw ! notice4  7e7      
,fur!r evaluation ,! ,adm9i/rator may   
review a *emical sub/ance "u section    
#d7;e7 at any "t aft] ! ,adm9i/rator    
receives--  7#a7 a notice ( comm5cem5t =
 a *emical sub/ance "u subsection 7d72  
or  7#b7 significant new in=mation      
reg>d+ ! *emical sub/ance4  7f7         
,transp>5cy ,subject to section #ad1 !  
,adm9i/rator %all make available to !   
public all notices1 rules & ord]s ( !   
,adm9i/rator1 & all data & in=mation    
submitt$ or issu$ "u ?is section4  2    
7#h7 by r$esignat+ subsections 7h7 & 7i7
 z subsections 7g7 & 7h71 respectively2 
&  7#i7 9 subsection 7g7 7z s           
r$esignat$7--  7,a7 9 p>agraph 7#a71 9 !

 matt] prec$+ subp>agraph 7,a71 by /rik+
 or 7b72  7,b7 by /rik+ p>agraph 7#b72  
7,c7 by r$esignat+ p>agraphs 7#c7 ?r\gh 
7#f7 z p>agraphs 7#b7 ?r\gh 7#e71       
respectively2  7,d7 9 p>agraph 7#b7 7z s
 r$esignat$71 by /rik+ subsections 7a7 &
 7b7 & ins]t+ subsection 7a72  7,e7 9   
p>agraph 7#c7 7z s r$esignat$71 9 ! fir/
 s5t5ce1 by /rik+ w n pres5t an         
unreasonable risk ( injury to heal? or !
 environm5t & ins]t+ is expect$ to meet 
! safety /&>d "u ! int5d$ conditions (  
use2  7,f7 9 p>agraph 7#d7 7z s         
r$esignat$71 by /rik+ subsections 7a7 & 
7b7 & ins]t+ subsection 7a72 &  7,g7 9  
p>agraph 7#e7 7z s r$esignat$71 9 ! fir/
 s5t5ce1 by /rik+ p>agraph 7#a7 or 7#e7 
& ins]t+ p>agraph 7#a7 or 7#d714  #f4   
,safety assessm5ts & det]m9ations       
,section #f 7#ae ,u4,s4,c4 #bfje7 is    
am5d$--  7#a7 by /rik+ ! section        
designation & head+ & ins]t+ ! foll[+3  
#f4 ,safety assessm5ts & det]m9ations  2
  7#b7 by /rik+ subsections 7a7 ?r\gh   
7d7 & ins]t+ ! foll[+3  7a7 ,9 g5]al ,! 

,adm9i/rator %all--  7#a7 conduct a     
safety assessm5t ( ea* high-priority    
sub/ance 9 accordance ) subsection 7b72 
7#b7 make a safety det]m9ation = ea*    
high-priority sub/ance2 &  7#c7 z       
appropriate bas$ on ! results ( a safety
 det]m9ation1 e/abli% requirem5ts = risk
 managem5t ( a high-priority sub/ance4  
7b7 ,safety assessm5ts  7#a7 ,9 g5]al ,!
 ,adm9i/rator %all conduct a risk-bas$  
safety assessm5t ( ea* high-priority    
sub/ance1 9 accordance ) su* s*$ule z ! 
,adm9i/rator e/abli%es1 to be bas$      
solely on consid]ations ( risk to human 
heal? & ! environm5t4  7#b7 ,proc$ural  
rules  7,a7 ,9 g5]al ,! ,adm9i/rator    
%all e/abli% proc$ural rules = safety   
assessm5ts & det]m9ations "u ?is        
subsection1 includ+ s*$ules = !         
submission ( relevant data & in=mation &
 ! initiation & completion ( safety     
assessm5ts & safety det]m9ations4  7,b7 
,requirem5ts  7i7 ,9 g5]al ,! rules "u  
subp>agraph 7,a7 %all--  7,i7 id5tify ! 
basis on :i* ! ,adm9i/rator %all decide 

:i* high-priority sub/ances take        
prec$5ce 9 ! safety assessm5t &         
det]m9ation process2  7,,ii7 require !  
,adm9i/rator to in=m ! public reg>d+--  
7aa7 ! approximate ord] 9 :i* safety    
assessm5ts & det]m9ations w be p]=m$2   
7bb7 ! in=mational ne$s ( ! ,adm9i/rator
 relat+ to ! safety assessm5t &         
det]m9ation process2  7cc7 ! importance 
( exp$iti\sly complet+ safety assessm5ts
 & det]m9ations & ! ne$ = rigor\s       
evaluation ( ! data & in=mation2  7dd7 !
 s*$ule by :i* ea* assessm5t &          
det]m9ation w be conduct$2 &  7ee7      
subject to clause 7ii71 ! deadl9e = !   
completion ( ea* assessm5t &            
det]m9ation2  7,,iii7 all[ int]e/$      
p]sons1 includ+ ,/ates1 to submit       
in=mation1 includ+ safety assessm5ts1   
reg>d+ high-priority sub/ances t may    
facilitate ! safety assessm5t &         
det]m9ation process2 &  7,,iv7 subject  
to section #ad1 require ! ,adm9i/rator--
  7aa7 to make available to ! public !  
in=mation tak5 into consid]ation 9      

prep>+ ea* safety assessm5t &           
det]m9ation2  7bb7 to publi% & provide  
an opportunity = comm5t on propos$      
safety assessm5ts & det]m9ations2 &     
7cc7 to publi% f9al safety assessm5ts & 
det]m9ations4  7ii7 ,deadl9es  7,i7 ,9  
g5]al ,! rules describ$ 9 subp>agraph   
7,a7 %all also include--  7aa7 a s*$ule 
by :i* ea* safety assessm5t &           
det]m9ation is expect$ to be conduct$2 &
  7bb7 a deadl9e = ! completion ( ea*   
assessm5t & det]m9ation4  7,,ii7        
,flexibility & reasonable ext5sions ,!  
deadl9es describ$ 9 subclause 7,i77bb7--
  7aa7 may v>y among *emical sub/ances  
to grant ! ,adm9i/rator flexibility2 &  
7bb7 %all all[ = reasonable ext5sions   
aft] an adequate public ju/ification4   
7,c7 ,inclusions 9 f9al assessm5ts ,ea* 
safety assessm5t "u ?is subsection %all 
include--  7i7 a weight-(-! evid5ce     
summ>y2 &  7ii7 a nonte*nical summ>y    
expla9+ :at ! relevant in=mation        
demon/rates 9 ! context ( ! int5d$      
conditions ( use & exposure patt]ns ( ! 

*emical sub/ance4  7#c7 ,data &         
in=mation s\rces ,9 conduct+ a safety   
assessm5t "u ?is subsection1 !          
,adm9i/rator %all1 at a m9imum1 take    
into consid]ation--  7,a7 ! in=mation   
describ$ 9 section #d7;c72 &  7,b7 any  
additional in=mation submitt$ "u        
p>agraph 7#e74  7#d7 ,me?odology  7,a7  
,9 g5]al ,! ,adm9i/rator %all--  7i7    
develop an appropriate sci5ce-bas$      
me?odology = conduct+ safety assessm5ts 
"u ?is subsection1 :i* %all include     
consid]ation ( ! weight ( ! evid5ce =   
obs]v$ effects1 me*ani/ic in=mation1 &  
exposure evaluations2 &  7ii7 make !    
propos$ me?odology available = public   
comm5t & sci5tific pe] review4  7,b7    
,review & revisions ,n lat] ?an #e ye>s 
aft] ! date ( enactm5t ( ! ,*emical     
,safety ,improvem5t ,act1 & n less      
frequ5tly ?an once e #e ye>s !reaft]1 ! 
,adm9i/rator--  7i7 %all review !       
me?odology develop$ "u subp>agraph 7,a72
 &  7ii7 may revise ! me?odology to     
reflect new sci5tific developm5ts or    

und]/&+s1 9 accordance ) subp>agraph    
7,a74  7,c7 ,requirem5ts ,! me?odology  
%all apply sci5tifically recogniz$      
factors to address ! foll[+ topics3  7i7
 ,/r5g?s & limitations ( /udy design4   
7ii7 ,reliability & relevance ( te/     
me?ods to human heal? & ! environm5t4   
7iii7 ,quality ( data4  7iv7 ,use ( good
 laboratory practices4  7v7 ,pe] review 
& pe] review processes4  7vi7 ,use (    
/&>diz$ protocols4  7vii7 ,/ructur$     
evaluative frameworks to det]m9e !      
ov]all weight ( ! evid5ce1 bas$ on a    
review ( positive & negative f9d+s4     
7,d7 ,haz>d1 use1 & exposure in=mation  
7i7 ,9 g5]al ,a safety assessm5t "u ?is 
subsection %all evaluate exi/+ haz>d1   
use1 & exposure in=mation = ! *emical   
sub/ance "u ! int5d$ conditions ( use ( 
! *emical sub/ance1 includ+ in=mation   
submitt$ by int]e/$ p]sons4  7ii7       
,exposure ,= purposes ( evaluat+        
exposure "u clause 7i71 a safety        
assessm5t %all take into consid]ation-- 
7,i7 exposures or significant subsets ( 

exposures2  7,,ii7 exposure duration1   
int5sity1 frequ5cy1 & numb]2 &  7,,iii7 
! vuln]ability ( expos$ subpopulations4 
7,e7 ,be/ available sci5ce ,!           
,adm9i/rator %all use ! be/ available   
sci5ce 9 conduct+ a safety assessm5t "u 
?is subsection4  7#e7 ,additional te/   
in=mation ,if ! ,adm9i/rator det]m9es t 
additional te/ in=mation is ne$$ 9 ord] 
to make a safety assessm5t = a          
high-priority sub/ance1 ! ,adm9i/rator--
  7,a7 %all provide an opportunity =    
int]e/$ p]sons to submit ! additional   
in=mation2  7,b7 may promulgate a rule1 
ent] into a te/+ cons5t agreem5t1 or    
issue an ord] "u section #d to require !
 developm5t ( ! in=mation2 &  7,c7 may  
def]1 = a reasonable p]iod1 a safety    
assessm5t until aft] receipt ( !        
in=mation4  7#f7 ,treatm5t ,a safety    
assessm5t "u ?is subsection--  7,a7 %all
 n be consid]$ to be a f9al ag5cy       
action2 &  7,b7 %all n be subject to    
judicial review4  7c7 ,safety           
det]m9ation  7#a7 ,9 g5]al ,z soon z    

possible aft] ! date on :i* ! safety    
assessm5t is complet$ = a high-priority 
sub/ance "u subsection 7b71 !           
,adm9i/rator %all det]m9e :e!r ! *emical
 sub/ance meets ! safety /&>d "u !      
int5d$ conditions ( use ( ! *emical     
sub/ance4  7#b7 ,det]m9ations ,bas$ on a
 review ( ! in=mation describ$ 9        
p>agraph 7#c71 ! ,adm9i/rator %all      
det]m9e1 bas$ solely on consid]ations ( 
risk to human heal? & ! environm5t1 t-- 
7,a7 ! relevant *emical sub/ance meets !
 safety /&>d "u int5d$ conditions ( use2
  7,b7 ! relevant *emical sub/ance does 
n meet ! safety /&>d "u int5d$          
conditions ( use1 9 :i* case !          
,adm9i/rator %all impose additional     
re/rictions1 z appropriate1 "u p>agraph 
7#i72 or  7,c7 additional in=mation is  
necess>y 9 ord] to make a det]m9ation "u
 subp>agraph 7,a7 or 7,b71 9 :i* case ! 
,adm9i/rator %all take appropriate      
action "u p>agraph 7#h74  7#c7          
,consid]ations ,9 mak+ a safety         
det]m9ation "u ?is subsection1 !        

,adm9i/rator %all take into consid]ation
 & publi% a /atem5t t includes1 at a    
m9imum--  7,a7 ! safety assessm5t = !   
*emical sub/ance1 includ+ ! uses        
consid]$ 9 ! assessm5t & any uses t are 
consid]$ critical or ess5tial2  7,b7 !  
range ( exposure to ! *emical sub/ance  
"u ! int5d$ conditions ( use ( ! *emical
 sub/ance & appropriate ref]5ce         
p>amet]s2  7,c7 ! weight ( ! evid5ce (  
risk pos$ by ! *emical sub/ance "u !    
int5d$ conditions ( use ( ! *emical     
sub/ance2 &  7,d7 ! magnitude ( ! risk  
pos$ by ! *emical sub/ance "u ! int5d$  
conditions ( use ( ! *emical sub/ance4  
7#d7 ,in=mation s\rces ,9 mak+ a safety 
det]m9ation "u ?is subsection1 !        
,adm9i/rator %all take into             
consid]ation1 at a m9imum--  7,a7 !     
in=mation describ$ 9 section #d7;c72 &  
7,b7 ! safety assessm5t conduct$ )      
respect to ! *emical sub/ance "u        
subsection 7b74  7#e7 ,be/ available    
sci5ce ,! ,adm9i/rator %all use ! be/   
available sci5ce 9 mak+ a safety        

det]m9ation "u ?is subsection4  7#f7    
,notice & comm5t ,subject to section    
#ad1 ! ,adm9i/rator %all provide notice 
& an opportunity = public comm5t on ea* 
propos$ safety det]m9ation "u ?is       
subsection4  7#g7 ,transp>5cy ,subject  
to section #ad1 ! ,adm9i/rator %all     
publi%--  7,a7 ea* safety det]m9ation "u
 ?is subsection1 toge!r ) a summ>y ( !  
in=mation consid]$ 9 ! det]m9ation2     
7,b7 a summ>y ( ! evaluation by !       
,adm9i/rator ( ! in=mation2 &  7,c7 an  
explanation ( ! reasons = ! det]m9ation4
  7#h7 ,additional te/ data & in=mation 
,if ! ,adm9i/rator det]m9es t additional
 te/ data & in=mation is ne$$ 9 ord] to 
make a safety det]m9ation = a           
high-priority sub/ance1 ! ,adm9i/rator--
  7,a7 %all provide an opportunity =    
int]e/$ p]sons to submit ! additional   
data & in=mation2  7,b7 may promulgate a
 rule1 ent] into a te/+ cons5t agreem5t1
 or issue an ord] "u section #d to      
require ! developm5t ( ! data &         
in=mation2  7,c7 may def]1 = a          

reasonable p]iod1 a safety det]m9ation  
until aft] receipt ( ! data & in=mation2
 &  7,d7 on receipt ( ! data &          
in=mation1 %all make a det]m9ation "u   
p>agraph 7#b74  7#i7 ,additional        
re/rictions  7,a7 ,9 g5]al  7i7         
,det]m9ation ,if ! ,adm9i/rator makes a 
det]m9ation "u p>agraph 7#b77;,b7 )     
respect to a *emical sub/ance1 !        
,adm9i/rator %all promulgate a rule     
e/abli%+ necess>y re/rictions 7bas$ on !
 weight ( ! evid5ce ( risk & ! magnitude
 ( risk71 includ+ if appropriate1 a ban 
or phase out ( ! manufacture1 process+1 
or use ( ! *emical sub/ance 9 accordance
 ) subp>agraph 7,c74  7ii7 ,rules ,rules
 promulgat$ "u ?is section may apply to 
mixtures conta9+ ! *emical sub/ance1 z  
appropriate4  7,b7 ,inclusions ,a       
re/riction "u subp>agraph 7,a7 may      
include1 z appropriate--  7i7 a         
requirem5t t a *emical sub/ance be m>k$ 
)1 or accompani$ by1 cle> & adequate    
w>n+s & in/ructions ) respect to use1   
di/ribution 9 comm]ce1 or disposal1 or  

any comb9ation ( ^? activities1 ) ! =m &
 cont5t ( ! w>n+s & in/ructions to be   
prescrib$ by ! ,adm9i/rator2  7ii7 a    
requirem5t t manufactur]s & processors (
 ! *emical sub/ance--  7,i7 make & reta9
 records ( ! processes us$ to           
manufacture or process ! *emical        
sub/ance2 &  7,,ii7 subject to section  
#d7;f71 develop te/ in=mation t is      
reasonably necess>y to ensure compliance
 ) ?is ,act2  7iii7 a limitation on !   
quantity ( ! *emical sub/ance t may be  
manufactur$1 process$1 or di/ribut$ 9   
comm]ce2  7iv7 a requirem5t to ban or   
phase out or o!r regulation on !        
manufacture1 process+1 or di/ribution 9 
comm]ce ( ! *emical sub/ance--  7,i7 = a
 p>ticul> use2 or  7,,ii7 = a p>ticul>  
use at a conc5tration 9 excess ( a level
 specifi$ by ! ,adm9i/rator2  7v7 a     
limitation on ! quantity ( ! *emical    
sub/ance t may be manufactur$1 process$1
 or di/ribut$ 9 comm]ce--  7,i7 = a     
p>ticul> use2 or  7,,ii7 = a p>ticul>   
use at a conc5tration 9 excess ( a level

 specifi$ by ! ,adm9i/rator2  7vi7 a    
requirem5t to ban or phase out or o!r   
regulation ( any me?od ( comm]cial use (
 ! *emical sub/ance2  7vii7 a requirem5t
 to ban or phase out or o!r regulation (
 any me?od ( disposal ( ! *emical       
sub/ance or any article conta9+ !       
*emical sub/ance2  7viii7 a requirem5t  
direct+ manufactur]s or processors ( !  
*emical sub/ance to give notice (       
unreasonable risks ( h>m to di/ributors 
9 comm]ce ( ! *emical sub/ance &1 to !  
ext5t reasonably asc]ta9able1 to o!r    
p]sons 9 ! *a9 ( comm]ce 9 possession ( 
! *emical sub/ance2 &  7ix7 su* o!r     
requirem5ts z ! ,adm9i/rator det]m9es to
 be necess>y4  7,c7 ,bans & phase outs  
,! ,adm9i/rator %all base a det]m9ation 
"u subp>agraph 7,a7 t a ban or phase out
 ( ! manufacture1 process+1 or use ( a  
*emical sub/ance is necess>y on !       
consid]ations describ$ 9 subp>agraph    
7,d74  7,d7 ,det]m9ation t *emical      
sub/ance does n meet safety /&>d ,if !  
,adm9i/rator det]m9es t ! *emical       

sub/ance does n meet ! safety /&>d "u ! 
int5d$ conditions ( use1 ! ,adm9i/rator 
%all consid] & publi% a /atem5t on--    
7i7 ! availability ( te*nically &       
economically feasible alt]natives = !   
*emical sub/ance "u ! int5d$ conditions 
( use2  7ii7 ! risks pos$ by ^?         
alt]natives z comp>$ to ^? ( ! *emical  
sub/ance2  7iii7 ! economic & social    
co/s & b5efits ( ! propos$ regulatory   
action & options consid]$1 & ( pot5tial 
alt]natives2 &  7iv7 ! economic & social
 b5efits & co/s (--  7,i7 ! *emical     
sub/ance2  7,,ii7 alt]natives to !      
*emical sub/ance2 &  7,,iii7 any        
necess>y re/rictions on ! *emical       
sub/ance or alt]natives4  7#aj7         
,exemptions ,! ,adm9i/rator may exempt !
 use ( a *emical sub/ance f any         
additional re/riction e/abli%$ "u       
p>agraph 7#i7 if ! ,adm9i/rator det]m9es
 t--  7,a7 ! exemption is 9 ! int]e/ (  
national security2  7,b7 ! lack (       
availability ( ! *emical sub/ance w\ld  
cause significant disruption 9 !        

national economy2  7,c7 ! use = :i* !   
exemption is s\ght is a critical or     
ess5tial use = :i*--  7i7 no feasible   
alt]native = ! use w\ld mat]ially r$uce 
risk to heal? or ! environm5t2 or  7ii7 
no feasible alt]native = ! use is       
economically1 te*nically1 or effici5tly 
available2 or  7,d7 ! use1 z comp>$ to  
reasonably available alt]natives1       
provides a net b5efit to human heal?1 ! 
environm5t1 or public safety4  7#aa7    
,f9al ag5cy action ,a safety det]m9ation
 "u ?is subsection %all be--  7,a7      
consid]$ to be a f9al ag5cy action2 &   
7,b7 subject to judicial review1 includ+
 review ( ! associat$ safety assessm5t  
"u ?is subsection4  2  7#c7 by          
r$esignat+ subsections 7e7 & 7f7 z      
subsections 7d7 & 7e71 respectively2 &  
7#d7 9 subsection 7d7 7z s r$esignat$7--
  7,a7 by /rik+ p>agraph 7#d72 &  7,b7  
by r$esignat+ p>agraph 7#e7 z p>agraph  
7#d74  #g4 ,imm95t haz>ds ,section #g   
7#ae ,u4,s4,c4 #bfjf7 is am5d$--  7#a7  
by /rik+ subsection 7a7 & ins]t+ !      

foll[+3  7a7 ,civil actions  7#a7 ,9    
g5]al ,! ,adm9i/rator may comm5ce a     
civil action 9 an appropriate di/rict   
c\rt ( ! ,unit$ ,/ates =--  7,a7 seizure
 ( an imm95tly haz>d\s *emical sub/ance 
or mixture or any article conta9+ !     
sub/ance or mixture2  7,b7 relief 7z    
au?oriz$ by subsection 7b77 aga9/ any   
p]son :o manufactures1 processes1       
di/ributes 9 comm]ce1 uses1 or disposes 
(1 an imm95tly haz>d\s *emical sub/ance 
or mixture or any article conta9+ !     
sub/ance or mixture2 or  7,c7 bo?       
seizure describ$ 9 subp>agraph 7,a7 &   
relief describ$ 9 subp>agraph 7,b74     
7#b7 ,rule1 ord]1 or o!r proce$+ ,a     
civil action may be comm5c$ "u ?is      
p>agraph not)/&+--  7,a7 ! exi/5ce (--  
7i7 a decision by ! ,adm9i/rator "u     
section #d7;c77#c71 #e7;c77#d71 or      
#f7;c77#b72 or  7ii7 a rule1 te/+ cons5t
 agreem5t1 or ord] "u section #d7;f71   
#e7;g71 #f7;b77#e71 #f7;c77#h71         
#f7;c77#i71 or #f7;d72 or  7,b7 ! p5d5cy
 ( any adm9i/rative or judicial proce$+ 

"u any provision ( ?is ,act4  2  7#b7 9 
subsection 7d71 by /rik+ section #f7;a7 
& ins]t+ section #f7;c72 &  7#c7 9      
subsection 7f71 9 ! fir/ s5t5ce1 by     
/rik+ & unreasonable4  #h4 ,in=mation   
collection & report+ ,section #h 7#ae   
,u4,s4,c4 #bfjg7 is am5d$--  7#a7 9     
subsection 7a71 by add+ at ! end !      
foll[+3  7#d7 ,regulations  7,a7 ,9     
g5]al ,! ,adm9i/rator %all promulgate   
rules requir+ ! report+ ( in=mation kn[n
 by1 or reasonably asc]ta9able by1 !    
p]son mak+ ! report1 includ+ rules      
requir+ processors to report in=mation1 
s t ! ,adm9i/rator has ! in=mation      
necess>y to c>ry out sections #d & #f4  
7,b7 ,cont5ts ,! rules promulgat$ "u    
subp>agraph 7,a7--  7i7 may impose      
diff]5t report+ requirem5ts on          
manufactur]s & processors2  7ii7 %all be
 limit$ to active sub/ances or mixtures 
conta9+ active sub/ances z designat$ "u 
subsection 7b72 &  7iii7 %all apply only
 to ! ext5t ! ,adm9i/rator det]m9es !   
submission ( reports is necess>y = !    

effective en=cem5t ( ?is ,act4  7#e7    
,guidance ,! ,adm9i/rator %all develop  
guidance relat+ to ! in=mation requir$  
to be report$ "u ! rules promulgat$ "u  
?is subsection t--  7,a7 include ! level
 ( detail necess>y to be report$2 &     
7,b7 describes ! mann] by :i*           
manufactur]s & processors may report use
 & exposure in=mation on a volunt>y     
basis4  2  7#b7 9 subsection 7b71 by    
add+ at ! end ! foll[+3  7#c7           
,nom5clature  7,a7 ,9 g5]al ,9 c>ry+ out
 p>agraph 7#a71 ! ,adm9i/rator %all--   
7i7 ma9ta9 ! use ( ,class #b nom5clature
 9 use on date ( enactm5t ( ! ,*emical  
,safety ,improvem5t ,act2  7ii7 ma9ta9 !
 use ( ! ,soap & ,det]g5t ,association  
,nom5clature ,sy/em1 publi%$ 9 ,m>*     
#aigh by ! ,adm9i/rator 9 section #a (  
add5dum ,,iii ( ! docum5t entitl$       
,c&idate ,li/ ( ,*emical ,sub/ances1 &  
fur!r describ$ 9 ! app5dix ,a ( volume  
,i ( ! #aihe edition ( ! ,toxic         
,sub/ances ,control ,act ,sub/ances     
,inv5tory 7,,epa ,docum5t ,no4          

,,epa-#efj_/g-he-jjb;a72 &  7iii7 treat 
all compon5ts ( categories t are        
consid]$ to be /atutory mixtures "u ?is 
,act z be+ includ$ on ! li/ publi%$ "u  
p>agraph 7#a7 "u ! ,*emical ,ab/racts   
,s]vice numb]s = ! respective           
categories1 includ+1 )\t limitation--   
7,i7 cem5t1 ,portl&1 *emicals1 ,,cas    
,no4 #feiig-ae-a2  7,,ii7 cem5t1 alum9a1
 *emicals1 ,,cas ,no4 #feiig-af-b2      
7,,iii7 glass1 oxide1 *emicals1 ,,cas   
,no4 #feiig-ag-c2  7,,iv7 frits1        
*emicals1 ,,cas ,no4 #feiig-ah-d2  7,v7 
/eel manufacture1 *emicals1 ,,cas ,no4  
#feiig-ai-e2 &  7,,vi7 c]amic mat]ials &
 w>es1 *emicals1 ,,cas ,no4 #ffdjb-fh-d4
  7,b7 ,multiple nom5clature conv5tions 
7i7 ,9 g5]al ,9 ! ev5t t exi/+ guidance 
all[s = multiple nom5clature conv5tions1
 ! ,adm9i/rator %all--  7,i7 ma9ta9 !   
nom5clature conv5tions = sub/ances2 &   
7,,ii7 develop new guidance t--  7aa7   
e/abli%es equival5cy betwe5 !           
nom5clature conv5tions = *emical        
sub/ances on ! li/ publi%$ "u p>agraph  

7#a72 &  7bb7 p]mits p]sons to rely on t
 new guidance = purposes ( det]m9+ :e!r 
a *emical sub/ance is on ! li/ publi%$  
"u p>agraph 7#a74  7ii7 ,multiple ,,cas 
numb]s ,= any *emical sub/ance appe>+   
multiple times on ! li/ "u diff]5t      
,*emical ,ab/racts ,s]vice numb]s1 !    
,adm9i/rator %all develop guidance      
recogniz+ ! multiple li/+s z a s+le     
*emical sub/ance4  7#d7 ,c&idate li/ (  
active sub/ances 9 comm]ce  7,a7 ,9     
g5]al ,subject to section #ad1 !        
,adm9i/rator %all make publicly         
available a c&idate li/ ( active *emical
 sub/ances1 :i* %all include--  7i7 any 
*emical sub/ance report$ "u "p #gaa (   
title #dj1 ,code ( ,f$]al ,regulations1 
z 9 effect on ! date ( enactm5t ( !     
,*emical ,safety ,improvem5t ,act1 dur+ 
! p]iod beg9n+ on ! date t is #aj ye>s  
be=e ! date ( enactm5t ( ! ,*emical     
,safety ,improvem5t ,act & end+ on !    
date ( enactm5t ( ! ,*emical ,safety    
,improvem5t ,act2  7ii7 any *emical     
sub/ance = :i* a notice ( comm5cem5t (  

manufacture has be5 submitt$2  7iii7 any
 *emical sub/ance = :i* a significant   
new use notice has be5 submitt$2  7iv7  
any *emical sub/ance = :i* an export    
notification has be5 submitt$ dur+ !    
p]iod beg9n+ on ! date t is #aj ye>s    
be=e ! date ( enactm5t ( ! ,*emical     
,safety ,improvem5t ,act & end+ on !    
date ( enactm5t ( ! ,*emical ,safety    
,improvem5t ,act2 &  7v7 any o!r *emical
 sub/ance id5tifi$ by ! ,adm9i/rator z  
likely to qualify z active4  7,b7 ,rule 
,! ,adm9i/rator %all1 by rule1 require  
manufactur]s & processors to notify !   
,adm9i/rator t ! manufactur] or         
processor1 z applicable1 has manufactur$
 or process$ a *emical sub/ance on ! li/
 describ$ 9 subp>agraph 7,a71 or ! li/  
publi%$ "u p>agraph 7#a7 = a nonexempt  
comm]cial purpose dur+ ! #e-ye> p]iod   
prior to ! date ( enactm5t ( ! ,*emical 
,safety ,improvem5t ,act4  7,c7         
,guidance ,be=e issu+ a f9al rule "u    
subp>agraph 7,a71 ! ,adm9i/rator %all   
make publicly available guidance relat+ 

to ! rule = *emical sub/ances on !      
confid5tial portion ( ! c&idate li/ (   
active sub/ances & ( ! li/ publi%$ "u   
p>agraph 7#a71 includ+ --  7i7 accession
 numb]s2  7ii7 premanufacture notice    
case numb]s1 if applicable2 &  7iii7    
g5]ic names4  7,d7 ,confid5tial *emical 
sub/ances ,! rule "u subp>agraph 7,b7   
%all require a manufactur] or processor 
t is report+ in=mation relat+ to a      
*emical sub/ance on ! confid5tial       
portion ( ! li/ publi%$ "u p>agraph 7#a7
 to indicate :e!r ! manufactur] or      
processor claims ! specific id5tity ( ! 
sub/ance z confid5tial pursuant to      
section #ad4  7,e7 ,c]tification ,! rule
 "u subp>agraph 7,b7 %all require a     
manufactur] or processor--  7i7 to      
c]tify ! accuracy ( ea* report ( !      
manufactur] or processor c>ri$ out "u ! 
rule2 &  7ii7 to reta9 a record support+
 t c]tification = a p]iod ( #e ye>s     
beg9n+ on ! la/ day ( ! submission      
p]iod4  7,f7 ,applicability ,no?+ 9 ?is 
p>agraph requires ! resub/antiation ( a 

claim = protection aga9/ disclosure =   
in=mation submitt$ to ! ,adm9i/rator    
prior to ! date ( enactm5t ( ! ,*emical 
,safety ,improvem5t ,act4  7#e7 ,li/    
7,a7 ,9 g5]al ,bas$ on ! notifications  
receiv$ 9 response to ! rule "u p>agraph
 7#d71 ! ,adm9i/rator %all designate ea*
 *emical sub/ance t is on ! li/ publi%$ 
"u p>agraph 7#a7 on ! date ( enactm5t ( 
! ,*emical ,safety ,improvem5t ,act z   
active or inactive4  7,b7 ,update ,!    
,adm9i/rator %all update ! li/ (        
*emicals designat$ z active or inactive 
z soon z practicable foll[+ !           
publication ( ! mo/ rec5t data report$  
"u "p #gaa ( title #dj1 ,code ( ,f$]al  
,regulations4  7#f7 ,active sub/ances ,!
 ,adm9i/rator %all designate z an active
 sub/ance--  7,a7 a *emical sub/ance t  
has be5 manufactur$ or process$ = a     
nonexempt comm]cial purposes at any po9t
 dur+ ! #e-ye> p]iod prior to ! date (  
enactm5t ( ! ,*emical ,safety           
,improvem5t ,act2  7,b7 a *emical       
sub/ance t is add$ to ! li/ publi%$ "u  

p>agraph 7#a7 aft] ! date ( enactm5t ( !
 ,*emical ,safety ,improvem5t ,act2     
7,c7 a *emical sub/ance = :i* a notice  
is receiv$ "u p>agraph 7#g77;,c72 &     
7,d7 a *emical sub/ance report$ "u "p   
#gaa ( title #dj1 ,code ( ,f$]al        
,regulations1 aft] ! date ( enactm5t ( !
 ,*emical ,safety ,improvem5t ,act4     
7#g7 ,inactive sub/ances  7,a7 ,9 g5]al 
,! ,adm9i/rator %all designate z an     
inactive sub/ance ea* *emical sub/ance  
on ! li/ publi%$ "u p>agraph 7#a7 t has 
n be5 manufactur$ or process$ = a       
nonexempt comm]cial purpose 9 ! #e-ye>  
p]iod end+ on ! date ( enactm5t ( !     
,*emical ,safety ,improvem5t ,act4  7,b7
 ,treatm5t ,ea* inactive sub/ance %all  
rema9 on ! li/ publi%$ "u p>agraph 7#a74
  7,c7 ,*ange to active /atus  7i7 ,9   
g5]al ,any p]son :o int5ds to           
manufacture or process = a nonexempt    
comm]cial purpose a *emical sub/ance t  
is designat$ z an inactive sub/ance %all
 notify ! ,adm9i/rator be=e ! date on   
:i* ! sub/ance is manufactur$ or        

process$4  7ii7 ,active /atus ,on       
receiv+ notification "u clause 7i71 !   
,adm9i/rator--  7,i7 %all designate !   
*emical sub/ance z an active sub/ance2 &
  7,,ii7 %all1 pursuant to section      
#d7;e71 review ! priority ( ! *emical   
sub/ance z ! ,adm9i/rator det]m9es      
necess>y4  7,d7 ,category /atus ,! li/ (
 inactive *emical sub/ances %all n be   
consid]$ a category = purposes ( section
 #bf7;c74  7#h7 ,public p>ticipation    
7,a7 ,9 g5]al ,subject to subp>agraph   
7,b71 ! ,adm9i/rator %all make available
 to ! public--  7i7 ! specific id5tity (
 ea* *emical sub/ance on !              
nonconfid5tial portion ( ! li/ publi%$  
"u p>agraph 7#e7 t ! ,adm9i/rator has   
designat$ z an active sub/ance2  7ii7 ! 
specific id5tity ( ea* *emical sub/ance 
on ! nonconfid5tial portion ( ! li/     
publi%$ "u p>agraph 7#a7 t !            
,adm9i/rator has designat$ z an inactive
 sub/ance2  7iii7 ! accession numb]1    
g5]ic "n1 &1 if applicable1             
premanufacture notice case numb] = ea*  

*emical sub/ance on ! confid5tial       
portion ( ! li/ publi%$ "u p>agraph 7#a7
 = :i* a claim ( confid5tiality 0       
receiv$2 &  7iv7 ! specific id5tity (   
any active or inactive sub/ance on !    
confid5tial portion ( ! li/ publi%$ "u  
p>agraph 7#a7 = :i* no claim (          
confid5tiality 0 receiv$1 subject to !  
condition t1 be=e reveal+ ! specific    
id5tity ( ! sub/ance1 ! ,adm9i/rator    
%all--  7,i7 publi% a notice 9 ! ,f$]al 
,regi/] id5tify+ ! accession numb]1     
g5]ic "n1 &1 if applicable1             
premanufacture notice case numb] = t    
sub/ance2 &  7,,ii7 provide an          
opportunity = any p]son--  7aa7 to      
c]tify to ! ,adm9i/rator t ! p]son      
int5ds to manufacture or process !      
sub/ance at any po9t 9 ! subsequ5t      
#d-ye> p]iod2 &  7bb7 to claim          
confid5tiality = ! specific id5tity ( ! 
sub/ance4  7,b7 ,confid5tiality ,subject
 section #ad1 ! ,adm9i/rator %all n make
 available to ! public ! specific       
*emical id5tity ( any sub/ance = :i* !  

,adm9i/rator receives a notice "u       
subp>agraph 7,a77iv74  2 &  7#c7 9      
subsection 7e7--  7,a7 by /rik+ ,any    
p]son & ins]t+ ! foll[+3  7#a7 ,9 g5]al 
,any p]son  2 &  7,b7 by add+ at ! end !
 foll[+3  7#b7 ,applicability ,any p]son
 may submit to ! ,adm9i/rator data &    
in=mation reasonably support+ !         
conclusion t a *emical sub/ance or      
mixture does n pres5t a sub/antial risk 
( injury to heal? & ! environm5t4  4    
#i4 ,relation%ip to o!r ,f$]al laws     
,section #i 7#ae ,u4,s4,c4 #bfjh7 is    
am5d$--  7#a7 9 subsection 7a7--  7,a7 9
 ! fir/ s5t5ce ( p>agraph 7#a7--  7i7 by
 /rik+ pres5ts or w pres5t an           
unreasonable risk to heal? or !         
environm5t & ins]t+ does n meet ! safety
 /&>d "u ! int5d$ conditions ( use2 &   
7ii7 by /rik+ su* risk ! fir/ place x   
appe>s & ins]t+ ! risk pos$ by !        
sub/ance or mixture2  7,b7 9 p>agraph   
7#b71 9 ! matt] foll[+ subp>agraph 7,b71
 by /rik+ section #f or #g & ins]t+     
p>agraph 7#h7 or 7#i7 ( subsection 7c7 (

 section #f or section #g2 &  7,c7 9    
p>agraph 7#c71 by /rik+ section #f or #g
 & ins]t+ p>agraph 7#h7 or 7#i7 (       
subsection 7c7 ( section #f or section  
#g2 &  7#b7 9 subsection 7d71 9 ! fir/  
s5t5ce1 by /rik+ ,heal?1 ,education1 &  
,welf>e & ins]t+ ,heal? & ,human        
,s]vices4  #aj4 ,rese>*1 developm5t1    
collection1 dissem9ation1 & utilization 
( data ,section #aj 7#ae ,u4,s4,c4      
#bfji7 is am5d$ by /rik+ ,heal?1        
,education1 & ,welf>e ea* place x appe>s
 & ins]t+ ,heal? & ,human ,s]vices4     
#aa4 ,exports ,section #ab 7#ae         
,u4,s4,c4 #bfaa7 is am5d$--  7#a7 9     
subsection 7a71 by /rik+ p>agraph 7#b7 &
 ins]t+ ! foll[+3  7#b7 ,exception      
,p>agraph 7#a7 %all n apply to any      
*emical sub/ance t ! ,adm9i/rator       
det]m9es--  7,a7 "u section #e is n     
likely to meet ! safety /&>d "u ! int5d$
 conditions ( use ( ! *emical sub/ance2 
or  7,b7 "u section #f does n meet !    
safety /&>d "u ! int5d$ conditions ( use
 ( ! *emical sub/ance4  7#c7 ,waiv]s ,= 

a mixture or article conta9+ a *emical  
sub/ance describ$ 9 p>agraph 7#b71 !    
,adm9i/rator may--  7,a7 det]m9e t      
p>agraph 7#a7 %all n apply to t mixture 
or article2 &  7,b7 e/abli% a ?re%old   
conc5tration 9 a mixture or article at  
:i* p>agraph 7#a7 %all n apply4  2  7#b7
 by /rik+ subsection 7b7 & ins]t+ !     
foll[+3  7b7 ,notice  7#a7 ,9 g5]al ,a  
p]son %all notify ! ,adm9i/rator t !    
p]son is export+ or int5ds to export to 
a =eign c\ntry--  7,a7 a *emical        
sub/ance or a mixture conta9+ a *emical 
sub/ance t ! ,adm9i/rator has det]m9$ "u
 section #e is n likely to meet ! safety
 /&>d "u ! int5d$ conditions ( use ( !  
*emical sub/ance2  7,b7 a *emical       
sub/ance or a mixture conta9+ a *emical 
sub/ance t ! ,adm9i/rator has det]m9$ "u
 section #f does n meet ! safety /&>d "u
 ! int5d$ conditions ( use ( ! *emical  
sub/ance2 or  7,c7 a *emical sub/ance = 
:i* ! ,unit$ ,/ates is obligat$ by      
treaty to provide export notification4  
7#b7 ,regulations  7,a7 ,9 g5]al ,!     

,adm9i/rator %all promulgate regulations
 to c>ry out p>agraph 7#a74  7,b7       
,cont5ts ,! regulations promulgat$ "u   
subp>agraph 7,a7 %all--  7i7 include any
 exemptions ! ,adm9i/rator det]m9es to  
be appropriate1 :i* may include         
exemptions id5tifi$ "u section #e7;g72 &
  7ii7 indicate :e!r or to :at ext5t !  
regulations apply to articles conta9+ a 
*emical sub/ance or mixture describ$ 9  
p>agraph 7#a74  7#c7 ,notification ,!   
,adm9i/rator %all submit to ! gov]nm5t (
 ea* c\ntry to :i* a *emical sub/ance or
 mixture is export$--  7,a7 = a *emical 
sub/ance or mixture describ$ 9          
subp>agraph 7,a7 or 7,b7 ( p>agraph     
7#a71 a notice t in=mation on ! *emical 
sub/ance or mixture c be obta9$ f !     
,adm9i/rator1 unless ! ,adm9i/rator     
det]m9es t good cause exi/s n to provide
 ! notice2 &  7,b7 = a *emical sub/ance 
describ$ 9 p>agraph 7#a77;,c71 a notice 
t satisfies ! obligation ( ! ,unit$     
,/ates "u ! applicable treaty4  2 &     
7#c7 9 subsection 7c7--  7,a7 by /rik+  

p>agraph 7#c72 &  7,b7 by r$esignat+    
p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs   
7#c7 ?r\gh 7#e71 respectively4  #ab4    
,imports ,section #ac 7#ae ,u4,s4,c4    
#bfab7 is am5d$ to read z foll[s3  #ac4 
,imports  7a7 ,def9ition ( *emical      
sub/ance or mixture ,9 ?is section1 !   
t]m *emical sub/ance or mixture         
includes--  7#a7 a mixture conta9+ a    
*emical sub/ance or mixture2 &  7#b7 an 
article conta9+ a *emical sub/ance or   
mixture4  7b7 ,refusal ( entry  7#a7 ,9 
g5]al ,! ,secret>y ( ,homel& ,security  
%all refuse entry into ! cu/oms t]ritory
 ( ! ,unit$ ,/ates 7z def9$ 9 g5]al note
 #b to ! ,h>moniz$ ,t>iff ,s*$ule ( !   
,unit$ ,/ates7 any *emical sub/ance or  
mixture (f]$ = su* entry if--  7,a7 !   
,adm9i/rator has det]m9$ "u section     
#f7;c7 t ! *emical sub/ance or mixture  
does n meet ! safety /&>d "u ! int5d$   
conditions ( use ( ! *emical sub/ance2  
or  7,b7 ! *emical sub/ance or mixture  
is (f]$ = entry 9 violation ( a rule or 
ord] 9 effect "u ?is ,act4  7#b7        

,proc$ure  7,a7 ,9 g5]al ,subject to    
subp>agraph 7,b71 if a *emical sub/ance 
or mixture is refus$ entry "u p>agraph  
7#a71 ! ,secret>y ( ,homel& ,security-- 
7i7 %all notify ! consignee ( ! entry ( 
! refusal2  7ii7 %all n release !       
*emical sub/ance or mixture to !        
consignee2 &  7iii7 %all cause !        
disposal or /orage ( ! *emical sub/ance 
or mixture "u su* rules z ! ,secret>y   
may prescribe1 if ! *emical sub/ance or 
mixture has n be5 export$ by ! consignee
 9 ! #ij-;day p]iod beg9n+ on ! date (  
receipt ( ! notice ( ! refus$ entry4    
7,b7 ,exception  7i7 ,9 g5]al ,!        
,secret>y ( ,homel& ,security may1 p5d+ 
a review by ! ,adm9i/rator1 release to !
 consignee ! *emical sub/ance or mixture
 if ! consignee--  7,i7 executes a bond 
= ! am\nt ( ! full invoice ( ! *emical  
sub/ance or mixture 7z set =? 9 ! cu/oms
 entry72 &  7,,ii7 pays a duty on !     
*emical sub/ance or mixture4  7ii7      
,adm9i/ration ,if a consignee fails to  
return a *emical sub/ance or mixture    

releas$ to t consignee "u clause 7i7 =  
any cause to ! cu/ody ( ! ,secret>y (   
,homel& ,security :5 dem&$1 ! consignee 
%all be liable to ! ,unit$ ,/ates =     
liquidat$ damages equal to ! full am\nt 
( ! bond4  7,c7 ,/orage ,all *>ges =    
/orage1 c>tage1 & labor on & = !        
disposal ( a *emical sub/ance or mixture
 t is refus$ entry or releas$ "u ?is    
subsection %all be paid by ! own] or    
consignee1 & a default on t paym5t %all 
con/itute a li5 aga9/ any future entry  
made by ! own] or consignee4  7c7       
,notice  7#a7 ,9 g5]al ,a p]son (f]+ a  
*emical sub/ance or mixture subject to  
?is ,act = entry into ! cu/oms t]ritory 
( ! ,unit$ ,/ates %all--  7,a7 c]tify to
 ! ,secret>y ( ,homel& ,security t1 aft]
 reasonable inquiry & to ! be/ k &      
belief ( ! p]son1 ! *emical sub/ance or 
mixture is--  7i7 9 compliance ) any    
applicable rule1 cons5t agreem5t1 or    
ord] "u section #e or #f2 &  7ii7 7,i7  
includ$ on ! li/ "u section #h7;b72 or  
7,,ii7 exempt f any requirem5t to be    

includ$ on t li/2 &  7,b7 provide to !  
,secret>y ( ,homel& ,security any notice
 requir$ "u p>agraph 7#b74  7#b7 ,notice
 ,a p]son (f]+ a *emical sub/ance or    
mixture = entry into ! cu/oms t]ritory (
 ! ,unit$ ,/ates %all notify ! ,secret>y
 ( ,homel& ,security if--  7,a7 !       
*emical sub/ance is a high-priority     
sub/ance2  7,b7 ! *emical sub/ance is a 
*emical = :i* ! ,unit$ ,/ates is        
obligat$ to provide export notification 
by treaty2 or  7,c7 ! *emical sub/ance  
or mixture or any article conta9+ !     
sub/ance or mixture--  7i7 is ! subject 
( a safety assessm5t & safety           
det]m9ation conduct$ pursuant to section
 #f & has be5 f\nd n to meet ! safety   
/&>d2 &  7ii7 is id5tifi$ 9 a rule      
promulgat$ by ! ,secret>y ( ,homel&     
,security pursuant to subsection 7c7 z  
m]it+ notification due to ! pot5tial    
impact ( ! *emical sub/ance or mixture  
or any article conta9+ ! sub/ance or    
mixture on human heal? or ! environm5t4 
7d7 ,rules ,! ,secret>y ( ,homel&       

,security1 aft] consultation ) !        
,adm9i/rator1 %all issue rules = !      
adm9i/ration ( subsection 7c71 includ+  
:e!r1 or to :at ext5t1 ! provisions (   
subsections 7b7 & 7c7 apply4  4  #ac4   
,confid5tial in=mation ,section #ad 7#ae
 ,u4,s4,c4 #bfac7 is am5d$ to read z    
foll[s3  #ad4 ,confid5tial in=mation    
7a7 ,9 g5]al ,except z provid$ 9        
subsections 7c7 & 7e71 ! ,adm9i/rator   
%all n disclose in=mation describ$ 9    
subsection 7b7--  7#a7 t is report$ to1 
or o!rwise obta9$ by1 ! ,adm9i/rator "u 
?is ,act2 &  7#b7 = :i* ! requirem5ts ( 
subsection 7d7 are met4  7b7 ,in=mation 
g5]ally protect$ f disclosure  7#a7 ,9  
g5]al ,in=mation ref]r$ to 9 subsection 
7a7 includes confid5tial in=mation t is 
exempt f disclosure pursuant to         
subsection 7a7 ( section #eeb ( title   
#e1 ,unit$ ,/ates ,code1 "u subsection  
7b77#d7 ( t section4  7#b7 ,presumption 
( protection ,! foll[+ in=mation        
submitt$ by a manufactur]1 processor1 or
 di/ributor is presum$ to be protect$ f 

disclosure3  7,a7 ,specific in=mation   
describ+ ! manufacture1 process+1 or    
di/ribution 9 comm]ce ( a *emical       
sub/ance1 mixture1 or article4  7,b7    
,m>ket+ & sales in=mation4  7,c7        
,in=mation id5tify+ suppli]s or cu/om]s4
  7,d7 ,! id5tity ( con/itu5ts 9 a      
mixture & ! respective p]c5tages ( ^?   
con/itu5ts4  7,e7 ,specific in=mation   
ab\t ! use1 function1 or application ( a
 *emical sub/ance or mixture 9 a        
process1 mixture1 or product4  7,f7     
,specific production or import volumes (
 a manufactur] & specific volumes       
aggregat$ across manufactur]s if !      
,adm9i/rator det]m9es t disclosure ( !  
aggregat$ data c\ld reveal confid5tial  
in=mation4  7,g7 ,! specific id5tity ( a
 *emical sub/ance1 includ+ ! *emical "n1
 molecul> =mula1 ,*emical ,ab/racts     
,s]vice numb]1 & o!r in=mation t w\ld   
id5tify a specific *emical sub/ance1    
if--  7i7 ! specific id5tity 0 claim$ z 
confid5tial in=mation at ! "t x 0       
submitt$2 &  7ii7 ! claim has n         

subsequ5tly be5 )drawn or f\nd by !     
,adm9i/rator n to w>rant protection z   
confid5tial in=mation "u subsection 7g74
  7c7 ,in=mation n protect$ f disclosure
  7#a7 ,9 g5]al ,not)/&+ subsections 7a7
 & 7b71 & except z provid$ 9 p>agraph   
7#b71 ! foll[+ in=mation %all n be      
protect$ f disclosure3  7,a7 ,=         
in=mation submitt$ aft] ! date (        
enactm5t ( ! ,*emical ,safety           
,improvem5t ,act1 ! id5tity ( a *emical 
sub/ance if ! p]son submitt+ ! in=mation
 does n meet ! requirem5ts ( subsection 
7d74  7,b7 ,a safety assessm5t develop$ 
or a safety det]m9ation made "u section 
#f4  7,c7 ,heal? & safety data t are    
submitt$ "u ?is ,act ) respect to a     
*emical sub/ance or mixture t has be5   
(f]$ = comm]cial di/ribution z ( ! date 
on :i* ! /udy is to be disclos$ or = :i*
 te/+ is requir$ "u section #d4  7,d7   
,heal? & safety data 9 notices (        
sub/antial risk submitt$ "u section     
#h7;e7 & 9 ! und]ly+ /udies4  7,e7      
,g5]al in=mation describ+ ! manufactur+ 

volumes1 express$ 9 ranges w\ld n reveal
 confid5tial in=mation4  7,f7 ,g5]al    
descriptions ( indu/rial1 comm]cial1 or 
consum] functions & uses ( a *emical    
sub/ance or mixture4  7#b7 ,exception   
,in=mation elem5ts conta9$ 9 submissions
 describ$ 9 p>agraph 7#a7 t are o!rwise 
eligible = protection "u ?is section    
%all be protect$ f disclosure if !      
submitt] complies ) subsection 7d74  7d7
 ,requirem5ts = confid5tiality claims   
7#a7 ,claims  7,a7 ,9 g5]al ,= in=mation
 to be protect$ f disclosure "u ?is     
section1 a p]son :o submits in=mation to
 ! ,adm9i/rator "u ?is ,act %all--  7i7 
indicate ! in=mation t ! p]son believes 
is entitl$ to protection f disclosure "u
 ?is section 9 a submission to !        
,adm9i/rator 9 su* mann] & at su* "t z !
 ,adm9i/rator %all prescribe2 &  7ii7   
except 9 ! case ( in=mation describ$ 9  
subp>agraphs 7,a7 ?r\gh 7,f7 (          
subsection 7b77#b71 submit writt5       
docum5tation ju/ify+ :y ! in=mation     
qualifies = protection f disclosure4    

7,b7 ,c]tification ,an au?oriz$ (ficial 
( ! p]son describ$ 9 subp>agraph 7,a7   
%all c]tify t ! in=mation t has be5     
submitt$ is true & correct4  7#b7       
,additional requirem5ts = confid5tiality
 claims = *emical id5tities ,a p]son    
submitt+ in=mation "u ?is ,act relat$ to
 a *emical id5tity & :o claims          
protection f disclosure = t id5tity %all
 provide ! ,adm9i/rator )--  7,a7       
in=mation e/abli%+ t--  7i7 ! p]son     
takes reasonable measures to protect !  
confid5tiality ( ! *emical id5tity2     
7ii7 ! *emical id5tity is n requir$ to  
be disclos$1 or o!rwise made available1 
to ! public "u any o!r ,f$]al law 9     
connection ) "o or m uses subject to ?is
 ,act2  7iii7 disclosure ( ! *emical    
id5tity is likely to cause sub/antial   
h>m to ! competitive position ( ! p]son2
 &  7iv7 ! *emical id5tity is n         
reasonably believ$ to be readily        
discov]able ?r\gh rev]se eng9e]+2  7,b7 
! "t p]iod = :i* protection ( ! *emical 
id5tity f disclosure is necess>y2  7,c7 

a g5]ic "n = ! *emical sub/ance t !     
,adm9i/rator may disclose to ! public1  
subject to ! condition t ! g5]ic "n     
discloses a maximum am\nt ( in=mation on
 ! *emical /ructure ( ! sub/ance :ile   
protect+ ^? features ( ! *emical        
/ructure t are consid]$ confid5tial & ! 
disclosure ( :i* w\ld pot5tially h>m !  
competitive position ( ! p]son2 &  7,d7 
9 ! ev5t ! ,adm9i/rator makes a reque/  
"u subsection 7f7--  7i7 r$ocum5tation &
 rec]tification ( ! in=mation submitt$  
"u subsection 7a72 or  7ii7 )drawal ( ! 
claim = protection ( ! *emical id5tity f
 disclosure4  7#c7 ,guidance ,!         
,adm9i/rator %all develop guidance1 aft]
 notice & opportunity to comm5t1 on !   
det]m9ation ( g5]ic names = confid5tial 
*emical id5tities4  7e7 ,exceptions to  
protection f disclosure ,subsection 7a7 
%all n apply if--  7#a7 ! in=mation is  
to be disclos$ to an (fic] or employee (
 ! ,unit$ ,/ates 9 connection ) !       
(ficial duties ( t p]son "u any law = ! 
protection ( human heal? or ! environm5t

 or = specific law en=cem5t purposes2   
7#b7 ! in=mation is to be disclos$ to a 
contractor ) ! ,unit$ ,/ates & employees
 ( t contractor if1 9 ! op9ion ( !      
,adm9i/rator1 ! disclosure is necess>y =
 ! satisfactory p]=mance by ! contractor
 ( a contract ) ! ,unit$ ,/ates = !     
p]=mance ( "w 9 connection ) ?is ,act & 
"u su* conditions z ! ,adm9i/rator %all 
specify2  7#c7 ! ,adm9i/rator det]m9es t
 disclosure is necess>y to protect human
 heal? or ! environm5t2  7#d7 !         
in=mation is to be disclos$ to a ,/ate  
or political subdivision ( a ,/ate1 on  
writt5 reque/1 = ! purpose ( developm5t1
 adm9i/ration1 or en=cem5t ( a law1 if--
  7,a7 "o or m applicable agreem5ts ) ! 
,adm9i/rator ensure t ! recipi5t        
gov]nm5t w take appropriate /eps1 & has 
adequate au?ority1 to ma9ta9 !          
confid5tiality ( ! in=mation 9          
accordance ) proc$ures z /r+5t z ^? :i* 
! ,adm9i/rator uses to safegu>d !       
in=mation2 &  7,b7 ! ,adm9i/rator       
notifies ! p]son :o submitt$ ! in=mation

 t ! in=mation has be5 disclos$ to a    
,/ate or political subdivision ( a      
,/ate2  7#e7 a heal? pr(essional employ$
 by a ,f$]al or ,/ate ag5cy or a treat+ 
physician or nurse 9 a nonem]g5cy       
situation provides a writt5 /atem5t (   
ne$ & a writt5 confid5tiality agreem5t1 
subject to ! conditions t--  7,a7 !     
writt5 /atem5t ( ne$ is a /atem5t t !   
p]son has a reasonable basis to suspect 
t--  7i7 ! in=mation is ne$$ = purposes 
( diagnosis or treatm5t ( "o or m       
individuals2  7ii7 "o or m individuals  
be+ diagnos$ or treat$ h be5 expos$ to !
 *emical sub/ance conc]n$2 &  7iii7 k ( 
! specific *emical id5tity ( ! *emical  
sub/ance w assi/ 9 diagnosis or         
treatm5t2 &  7,b7 ! confid5tiality      
agreem5t provides t ! p]son w n use !   
specific *emical id5tity = any purpose  
o!r ?an ! heal? ne$s ass]t$ 9 ! /atem5t 
( ne$1 except z may o!rwise be au?oriz$ 
by ! t]ms ( ! agreem5t or by ! p]son    
submitt+ ! specific *emical id5tity to !
 ,adm9i/rator2  7#f7 a treat+ physician 

or nurse reque/s ! in=mation1 subject to
 ! conditions t--  7,a7 ! treat+        
physician or nurse det]m9es t--  7i7 a  
m$ical em]g5cy exi/s2  7ii7 ! specific  
*emical id5tity ( ! *emical sub/ance    
conc]n$ is necess>y = or w assi/ 9      
em]g5cy or fir/-aid diagnosis or        
treatm5t2 &  7iii7 ! "o or m individuals
 be+ diagnos$ or treat$ h likely be5    
expos$ to ! *emical sub/ance conc]n$2   
7,b7 if reque/$ by ! p]son submitt+ !   
specific *emical id5tity to !           
,adm9i/rator1 ! treat+ physician or     
nurse provides a writt5 /atem5t ( ne$ & 
a confid5tiality agreem5t z describ$ 9  
p>agraph 7#e72 &  7,c7 ! writt5         
confid5tiality agreem5t or /atem5t ( ne$
 is submitt$ z soon z practicable1 b n  
necess>ily be=e ! in=mation is disclos$2
  7#g7 ! ,adm9i/rator det]m9es t        
disclosure is necess>y 9 a proce$+ "u   
?is ,act1 subject to ! condition t !    
disclosure is made 9 su* a mann] z to   
pres]ve confid5tiality to ! maximum     
ext5t practicable )\t impair+ ! proce$+2

 or  7#h7 ! in=mation is to be disclos$1
 on writt5 reque/ ( any duly au?oriz$   
committee ( ! ,congress1 to t committee4
  7f7 ,duration ( protection f          
disclosure  7#a7 ,9 g5]al ,!            
,adm9i/rator %all protect f disclosure  
in=mation describ$ 9 subsection 7b7 t   
meets ! requirem5ts ( subsection 7d77#b7
 = ! p]iod ( "t reque/$ by ! p]son      
submitt+ ! claim or = su* p]iod ( "t z !
 ,adm9i/rator1 aft] review+ ! reque/ =  
confid5tial treatm5t & ! docum5tation1  
o!rwise det]m9es to be reasonable1      
unless--  7,a7 prior to ! expiration ( !
 p]iod1 ! p]son notifies ! ,adm9i/rator 
t ! p]son is )draw+ ! confid5tiality    
claim1 9 :i* case1 ! ,adm9i/rator %all  
promptly make ! in=mation available to !
 public2 or  7,b7 prior to ! expiration 
( ! p]iod1 ! ,adm9i/rator o!rwise       
becomes aw>e t ! ne$ = protection f     
disclosure c no long] be sub/antiat$1 9 
:i* case ! ,adm9i/rator %all take !     
actions describ$ 9 subsection 7g77#b74  
7#b7 ,r$ocum5tation ,! ,adm9i/rator may 

reque/--  7,a7 at any "t1 a p]son :o has
 reque/$ protection f disclosure = !    
id5tity ( a sub/ance "u subsection 7d7  
to r$ocum5t ! confid5tiality claim ( !  
p]son2 &  7,b7 any p]son :o has reque/$ 
t confid5tial in=mation be protect$ f   
disclosure "u section #h7;b7 to reass]t 
! confid5tiality claim ( ! p]son aft] ! 
*emical sub/ance is id5tifi$ z a        
high-priority sub/ance "u section       
#d7;e74  7g7 ,duties ( ! adm9i/rator    
7#a7 ,det]m9ation  7,a7 ,9 g5]al ,except
 z provid$ 9 subsection 7b77#b71 !      
,adm9i/rator %all--  7i7 review a reque/
 receiv$ "u ?is section to ma9ta9 !     
confid5tiality ( in=mation submitt$ "u  
?is ,act2 &  7ii7 det]m9e :e!r to       
approve1 modify1 or d5y t reque/4  7,b7 
,d5ial or modification  7i7 ,9 g5]al ,! 
,adm9i/rator %all d5y a claim to protect
 a *emical id5tity f disclosure only if 
! p]son :o has submitt$ ! reque/ fails  
to meet ! requirem5ts ( subsection 7d74 
7ii7 ,reasons = d5ial or modification ,!
 ,adm9i/rator %all provide to ! p]son :o

 has submitt$ ! reque/ a writt5 /atem5t 
( ! reasons = ! d5ial or modification ( 
! claim4  7,c7 ,subsets ,if x is n      
feasible = ! ,adm9i/rator to review ea* 
reque/ "u ?is section1 ! ,adm9i/rator   
%all review a repres5tative subset4     
7#b7 ,notification  7,a7 ,9 g5]al       
,except z provid$ 9 subsections 7c7 &   
7e71 if ! ,adm9i/rator d5ies a reque/ "u
 p>agraph 7#a71 ! ,adm9i/rator %all     
notify1 9 writ+ & by c]tifi$ mail1 !    
p]son :o submitt$ ! reque/ ( ! int5t ( !
 ,adm9i/rator to release ! in=mation4   
7,b7 ,release ( in=mation  7i7 ,9 g5]al 
,except z provid$ 9 clause 7ii71 !      
,adm9i/rator may n release in=mation "u 
?is subsection until ! date t is #cj    
days aft] ! date on :i* ! p]son :o      
submitt$ ! reque/ receives notification 
"u subp>agraph 7,a74  7ii7 ,exceptions  
7,i7 ,9 g5]al ,= in=mation "u p>agraph  
7#c7 or 7#h7 ( subsection 7e71 !        
,adm9i/rator may n release t in=mation  
until ! date t is #ae days aft] ! date  
on :i* ! p]son :o submitt$ ! reque/     

receives a notification1 unless !       
,adm9i/rator det]m9es t release ( !     
in=mation is necess>y to protect aga9/  
an imm95t & sub/antial h>m to human     
heal? or ! environm5t1 9 :i* case1 no   
prior notification is necess>y4  7,,ii7 
,no notification ,= in=mation "u        
p>agraph 7#f7 or 7#g7 ( subsection 7e71 
no prior notification is necess>y4  7#c7
 ,appeals  7,a7 ,9 g5]al ,a p]son :o    
receives notification "u ?is subsection 
may1 if ! p]son believes disclosure ( ! 
in=mation is prohibit$ "u subsection    
7a71 be=e ! date on :i* ! in=mation is  
to be releas$1 br+ an action to re/ra9  
disclosure ( ! in=mation 9--  7i7 !     
di/rict c\rt ( ! ,unit$ ,/ates 9 !      
di/rict 9 :i*--  7,i7 ! compla9ant      
resides or has ! pr9cipal place (       
bus9ess2 or  7,,ii7 ! in=mation is      
locat$2 or  7ii7 ! ,unit$ ,/ates        
,di/rict ,c\rt = ! ,di/rict ( ,columbia4
  7,b7 ,no disclosure ,! ,adm9i/rator   
%all n disclose any in=mation "u ?is    
section prior to ! date on :i* !        

applicable c\rt rules on an action "u   
subp>agraph 7,a74  7#d7 ,adm9i/ration ,9
 c>ry+ out ?is subsection1 !            
,adm9i/rator %all employ ! proc$ures 9  
"p #b ( title #dj1 ,code ( ,f$]al       
,regulations 7or successor regulations74
  7h7 ,crim9al p5alty = wrongful        
disclosure  7#a7 ,9 g5]al ,subject to   
p>agraph 7#b71 any (fic] or employee ( !
 ,unit$ ,/ates or =m] (fic] or employee 
( ! ,unit$ ,/ates1 :o--  7,a7 by virtue 
( t employm5t or (ficial position has   
obta9$ possession (1 or has access to1  
mat]ial ! disclosure ( :i* is prohibit$ 
by subsection 7a72 &  7,b7 kn[+ t       
disclosure ( t mat]ial is prohibit$ by  
subsection 7a71 willfully discloses !   
mat]ial 9 any mann] to any p]son n      
entitl$ to receive t mat]ial1 %all be-- 
7i7 guilty ( a misdemeanor & f9$ "u     
title #ah1 ,unit$ ,/ates ,code1         
imprison$ = n m ?an #a ye>1 or bo?2 &   
7ii7 remov$ f (fice or employm5t4  7#b7 
,o!r laws ,section #aije ( title #ah1   
,unit$ ,/ates ,code1 %all n apply )     

respect to ! publi%+1 divulg+1          
disclosure1 mak+ kn[n (1 or mak+        
available1 in=mation report$ or o!rwise 
obta9$ "u ?is ,act4  7#c7 ,contractors  
,= ! purposes ( ?is subsection1 any     
contractor ( ! ,unit$ ,/ates :o is      
furni%$ in=mation 9 accordance )        
subsection 7e77#b71 includ+ any employee
 ( t contractor1 %all be consid]$ to be 
an employee ( ! ,unit$ ,/ates4  7i7     
,applicability ,except z o!rwise provid$
 9 ?is section1 ! ,adm9i/rator %all h no
 au?ority--  7#a7 to require !          
docum5tation or r$ocum5tation ( a claim 
= ! protection f disclosure ( in=mation 
submitt$ to ! ,adm9i/rator "u ?is ,act  
prior to ! date ( enactm5t ( ! ,*emical 
,safety ,improvem5t ,act2 or  7#b7 to   
impose r$ocum5tation requirem5ts "u ?is 
,act t are m ext5sive ?an ^? requir$ "u 
?is section4  4  #ad4 ,prohibit$ acts   
,section #ae 7#ae ,u4,s4,c4 #bfad7 is   
am5d$ by /rik+ p>agraph 7#a7 & ins]t+ ! 
foll[+3  7#a7 fail or refuse to comply  
)--  7,a7 any rule promulgat$1 cons5t   

agreem5t ent]$ into1 or ord] issu$ "u   
section #d2  7,b7 any requirem5t        
prescrib$ by section #e or #f2  7,c7 any
 rule promulgat$1 cons5t agreem5t ent]$ 
into1 or ord] issu$ "u section #e or #f2
  7,d7 any requirem5t ( title ,,ii or   
any rule promulgat$ or ord] issu$ "u    
title ,,ii2 or  7,e7 any requirem5t (   
title ,,vii or any rule promulgat$ or   
ord] issu$ "u title ,,vii2  4  #ae4     
,preemption ,section #ah 7#ae ,u4,s4,c4 
#bfag7 is am5d$ by /rik+ subsections 7a7
 & 7b7 & ins]t+ ! foll[+3  7a7 ,9 g5]al 
,except z provid$ 9 subsections 7c7 &   
7d71 no ,/ate or political subdivision (
 a ,/ate may e/abli% or cont9ue to      
en=ce--  7#a7 a requirem5t = !          
developm5t ( te/ data or in=mation on a 
*emical sub/ance or category ( sub/ances
 t is reasonably likely to produce !    
same data & in=mation requir$ "u section
 #d1 #e1 or #f by--  7,a7 a rule        
promulgat$ by ! ,adm9i/rator2  7,b7 a   
cons5t agreem5t ent]$ into by !         
,adm9i/rator2 or  7,c7 an ord] issu$ by 

! ,adm9i/rator2  7#b7 a prohibition or  
re/riction on ! manufacture1 process+1  
or di/ribution 9 comm]ce or use ( a     
*emical sub/ance aft] issuance ( a      
complet$ safety det]m9ation = a *emical 
sub/ance "u section #f1 consi/5t ) !    
scope ( ! review & decisions address$ by
 ! ,adm9i/rator2 or  7#c7 a requirem5t =
 ! notification ( a use ( a *emical     
sub/ance t ! ,adm9i/rator has specifi$ z
 a significant new use & = :i* !        
,adm9i/rator has requir$ notification   
pursuant to a rule promulgat$ "u section
 #e4  7b7 ,new prohibitions or          
re/rictions ,except z provid$ 9         
subsections 7c7 & 7d71 no ,/ate or      
political subdivision ( a ,/ate may     
e/abli% 7aft] ! date ( enactm5t ( !     
,*emical ,safety ,improvem5t ,act7--    
7#a7 a prohibition or re/riction on !   
manufacture1 process+1 di/ribution 9    
comm]ce or use ( a *emical sub/ance t is
 a high-priority sub/ance id5tifi$ "u   
section #d7;e77#c7 7z ( ! date on :i* ! 
,adm9i/rator publi%es a s*$ule "u       

section #f7;b772 or  7#b7 a prohibition 
or re/riction on ! manufacture1         
process+1 di/ribution 9 comm]ce or use (
 a *emical sub/ance t is a l[-priority  
sub/ance id5tifi$ "u section #d7;e77#c74
  7c7 ,exceptions ,subsections 7a7 & 7b7
 %all n apply to a requirem5t1          
prohibition1 or re/riction ( a ,/ate or 
a political subdivision ( a ,/ate t--   
7#a7 is adopt$ "u ! au?ority ( any o!r  
,f$]al law2  7#b7 implem5ts a report+ or
 in=mation collection requirem5t n      
o!rwise requir$ by ! ,adm9i/rator "u ?is
 ,act or requir$ "u any o!r ,f$]al law2 
or  7#c7 is adopt$ pursuant to au?ority 
"u a law ( ! ,/ate or political         
subdivision ( ! ,/ate relat$ to wat]    
quality1 air quality1 or wa/e treatm5t  
or disposal t--  7,a7 does n impose a   
re/riction on ! manufacture1 process+1  
di/ribution 9 comm]ce1 or use ( a       
*emical sub/ance2 &  7,b7 is n o!rwise  
requir$ by or inconsi/5t ) an action by 
! ,adm9i/rator "u section #e or #f4  7d7
 ,/ate waiv]s ,^u application ( a ,/ate 

or political subdivision ( a ,/ate1 !   
,adm9i/rator may provide a waiv] f      
subsection 7a7 & subsection 7b77#a71    
reg>d+ a requirem5t ( t ,/ate or        
political subdivision ( ! ,/ate t       
relates to ! effects or exposure to any 
*emical sub/ance "u ! int5d$ conditions 
( use if--  7#a7 7,a7 ! ,/ate or        
political subdivision ( ! ,/ate det]m9es
 x _c wait until ! end ( ! p]iod        
specifi$ 9 ! e/abli%$ s*$ule & deadl9e =
 ! completion ( a full safety assessm5t 
& det]m9ation e/abli%$ "u section       
#f7;b77#b77;,b77ii72 &  7,b7 !          
,adm9i/rator det]m9es t--  7i7 compell+ 
,/ate or local conditions w>rant grant+ 
! waiv] to protect human heal? or !     
environm5t2  7ii7 compliance ) ! propos$
 requirem5t ( ! ,/ate or political      
subdivision ( ! ,/ate does n unduly     
burd5 int]/ate & =eign comm]ce 9 !      
manufacture1 process+1 di/ribution 9    
comm]ce1 or use ( a *emical sub/ance2   
7iii7 compliance ) ! propos$ requirem5t 
( ! ,/ate or political subdivision ( !  

,/ate w\ld n cause a violation ( any    
applicable ,f$]al law1 rule1 or ord]2 & 
7iv7 ! propos$ requirem5t ( ! ,/ate or  
political subdivision ( ! ,/ate is bas$ 
on ! be/ available sci5ce & is support$ 
by ! weight ( ! evid5ce2 or  7#b7 7,a7 !
 ,adm9i/rator f9ds a safety assessm5t or
 det]m9ation has be5 unreasonably       
delay$2 &  7,b7 ! ,/ate c]tifies t--    
7i7 ! ,/ate has a compell+ local int]e/ 
to protect human heal? or ! environm5t2 
7ii7 compliance ) ! propos$ requirem5t (
 ! ,/ate does n unduly burd5 int]/ate & 
=eign comm]ce 9 ! manufacture1 process+1
 di/ribution 9 comm]ce1 or use ( a      
*emical sub/ance2  7iii7 compliance ) ! 
propos$ requirem5t w\ld n cause a       
violation ( any applicable ,f$]al law1  
rule1 or ord]2 &  7iv7 ! propos$        
requirem5t is gr\nd$ 9 reasonable       
sci5tific conc]n4  7#c7 ,approval ( a   
,/ate ,waiv] ,reque/ ,! ,adm9i/rator    
%all grant or d5y a waiv] application-- 
7,a7 n lat] ?an #ahj days aft] ! date on
 :i* an application "u p>agraph 7#a7 is 

submitt$2 &  7,b7 n lat] ?an #ij days   
aft] ! date on :i* an application "u    
p>agraph 7#b7 is submitt$4  7#d7 ,notice
 & comm5t ,! application ( a ,/ate or   
political subdivision ( ! ,/ate %all be 
subject to public notice & comm5t4  7#e7
 ,f9al ag5cy action ,! decision ( !     
,adm9i/rator on ! application ( a ,/ate 
or political subdivision ( ! ,/ate %all 
be--  7,a7 consid]$ to be a f9al ag5cy  
action2 &  7,b7 subject to judicial     
review4  7#f7 ,duration ( ,/ate waiv]s  
,a ,/ate waiv]--  7,a7 grant$ "u        
p>agraph 7#a7 %all rema9 9 effect unless
 ! waiv] is f\nd to be 9 conflict ) a   
complet$ safety assessm5t & det]m9ation2
 &  7,b7 grant$ "u p>agraph 7#b7 %all   
rema9 9 effect until su* "t z ! safety  
assessm5t & det]m9ation is complet$4    
7#g7 ,judicial review ,n lat] ?an #fj   
days aft] ! date on :i* ! ,adm9i/rator  
makes a det]m9ation on an application ( 
a ,/ate or political subdivision ( !    
,/ate "u p>agraph 7#a71 any p]son may   
file a petition = judicial review 9 !   

,unit$ ,/ates ,c\rt ( ,appeals = !      
,di/rict ( ,columbia ,circuit1 :i* %all 
h exclusive jurisdiction ov] !          
det]m9ation4  7e7 ,effect on private    
rem$ies  7#a7 ,9 g5]al ,if !            
,adm9i/rator completes a safety         
det]m9ation = a high-priority sub/ance  
"u section #f1 ! det]m9ation %all be    
admissible z evid5ce 9 any public or    
private action 9 any c\rt ( ! ,unit$    
,/ates or ,/ate c\rt = recov]y ( damages
 or = equitable relief relat+ to injury 
to human heal? or ! environm5t f        
exposure to a *emical sub/ance4  7#b7   
,safety /&>d ,! safety det]m9ation %all 
be det]m9ative ( :e!r ! sub/ance meets !
 safety /&>d "u ! conditions ( use      
address$ 9 ! safety det]m9ation4  4     
#af4 ,judicial review ,section #ai 7#ae 
,u4,s4,c4 #bfah7 is am5d$--  7#a7 9     
subsection 7a7--  7,a7 by /rik+ p>agraph
 7#a7 & ins]t+ ! foll[+3  7#a7 ,fil+ (  
petition  7,a7 ,9 g5]al ,n lat] ?an #fj 
days aft] ! date ( ! promulgation ( a   
rule "u section #d7;f71 #f7;c71 #f7;e71 

or #h1 any p]son may file a petition =  
judicial review ( ! rule 9--  7i7 !     
,unit$ ,/ates ,c\rt ( ,appeals = !      
,di/rict ( ,columbia ,circuit2  7ii7 !  
circuit 9 :i* ! p]son resides2 or  7iii7
 ! circuit 9 :i* ! pr9cipal place (     
bus9ess ( ! p]son is locat$4  7,b7      
,exclusive jurisdiction ( c\rts (       
appeals ,! c\rts ( appeals ( ! ,unit$   
,/ates %all h exclusive jurisdiction (  
any action to obta9 judicial review 7o!r
 ?an 9 an en=cem5t proce$+7 "u          
subp>agraph 7,a7 if any di/rict c\rt ( !
 ,unit$ ,/ates w\ld h _h jurisdiction ( 
! action b = ?is p>agraph4  2  7,b7 9   
p>agraph 7#b71 by /rik+ p>agraph        
7#a77;,a7 & ins]t+ p>agraph 7#a72 &     
7,c7 by /rik+ p>agraph 7#c72 &  7#b7 9  
subsection 7c77#a71 by /rik+ subp>agraph
 7,b7 & ins]t+ ! foll[+3  7,b7          
,applicability ( section #gjf ( title   
#e1 ,unit$ ,/ates ,code  7i7 ,def9ition 
( evid5ce ,9 ?is subp>agraph1 ! t]m     
evid5ce means any matt] 9 ! rulemak+    
record4  7ii7 ,applicability ,section   

#gjf ( title #e1 ,unit$ ,/ates ,code1   
%all apply to review ( a rule "u ?is    
section1 except t--  7,i7 9 ! case ( a  
rule "u section #d7;f71 #f7;c71 or      
#f7;e7--  7aa7 ! /&>d ( review prescrib$
 9 section #gjf7b77;,e7 ( title #e1     
,unit$ ,/ates ,code1 %all n apply2 &    
7bb7 ! c\rt %all hold z unlawful & set  
aside ! rule if ! c\rt f9ds t ! rule is 
n support$ by sub/antial evid5ce 9 !    
rulemak+ record2 &  7,,ii7 ! c\rt %all n
 review ! cont5ts & adequacy ( ! /atem5t
 ( basis & purpose requir$ by section   
#eec7;c7 ( title #e1 ,unit$ ,/ates      
,code1 to be incorporat$ 9 ! rule except
 z "p ( a review ( ! rulemak+ record    
tak5 z a :ole4  4  #ag4 ,citiz5s'       
petitions ,section #ba 7#ae ,u4,s4,c4   
#bfbj7 is am5d$--  7#a7 9 subsection    
7a71 by /rik+ an ord] "u section #e7;e7 
or #f7;b77#b7 & ins]t+ an ord] "u       
section #d7;f7 or #e7;c72 &  7#b7 9     
subsection 7b7--  7,a7 9 p>agraph 7#a71 
by /rik+ an ord] "u section #e7;e71     
#f7;b77#a77;,a71 or #f7;b77#a77;,b7 &   

ins]t+ an ord] "u section #d7;f7 or     
#e7;c72 &  7,b7 by /rik+ subp>agraph    
7,b7 ( p>agraph 7#d7 & ins]t+ ! foll[+3 
7,b7 ,de novo proce$+  7i7 ,9 g5]al ,9  
an action "u subp>agraph 7,a7 to        
initiate a proce$+ to issue a rule "u   
section #d7;f71 #f7;b71 #f7;c71 #f7;d71 
or #h or an ord] issu$ "u section #d7;f7
 or #e7;c71 ! petition] %all be provid$ 
an opportunity to h ! petition consid]$ 
by ! c\rt 9 a de novo proce$+4  7ii7    
,demon/ration  7,i7 ,9 g5]al ,! c\rt    
%all ord] ! ,adm9i/rator to initiate !  
action reque/$ by ! petition] if !      
petition] demon/rates to ! satisfaction 
( ! c\rt by a prepond]ance ( ! evid5ce  
t--  7aa7 9 ! case ( a petition to      
initiate a proce$+ = ! issuance ( a rule
 or ord] "u section #d7;f71 ! in=mation 
available to ! ,adm9i/rator is          
insuffici5t = ! ,adm9i/rator to p]=m an 
action describ$ 9 section #d7;f71       
#f7;b77#e71 or #f7;c77#h72  7bb7 9 !    
case ( a petition to issue an ord] "u   
section #e7;c71 !re is a reasonable     

basis to conclude t ! sub/ance is n     
likely to meet ! safety /&>d "u ! int5d$
 conditions ( use2  7cc7 9 ! case ( a   
petition to initiate a proce$+ = !      
issuance ( a rule "u section #f7;c77#i71
 !re is a reasonable basis to conclude t
 ! sub/ance w n meet ! safety /&>d "u ! 
int5d$ conditions ( use2 or  7dd7 9 !   
case ( a petition to initiate a proce$+ 
= ! issuance ( a rule "u section        
#f7;b77#b71 #f7;d7 or #h1 !re is a      
reasonable basis to conclude t ! rule is
 necess>y to protect human heal? or !   
environm5t f an unreasonable risk ( h>m 
to human heal? or ! environm5t4  7,,ii7 
,def]m5t ,! c\rt may p]mit !            
,adm9i/rator to def] initiat+ ! action  
reque/$ by ! petition] until su* "t z ! 
c\rt prescribes if ! c\rt f9ds t--  7aa7
 ! ext5t ( ! risk to human heal? or !   
environm5t alleg$ by ! petition] is less
 ?an ! ext5t ( risks to human heal? or !
 environm5t ) respect to :i* !          
,adm9i/rator is tak+ action "u ?is ,act2
 &  7bb7 !re are insuffici5t res\rces   

available to ! ,adm9i/rator to take !   
action reque/$ by ! petition]4  4  #ah4 
,/udies ,section #be 7#ae ,u4,s4,c4     
#bfbd7 is repeal$4  #ai4 ,adm9i/ration  
,section #bf7;e7 7#ae ,u4,s4,c4         
#bfbe7;e77 is am5d$ by /rik+ ,heal?1    
,education1 & ,welf>e ea* place x appe>s
 & ins]t+ ,heal? & ,human ,s]vices4     
#bj4 ,developm5t & evaluation ( te/     
me?ods ,section #bg7;a7 7#ae ,u4,s4,c4  
#bfbf7;a77 is am5d$ by /rik+ ,heal?1    
,education1 & ,welf>e & ins]t+ ,heal? & 
,human ,s]vices4  #ba4 ,/ate programs   
,section #bh 7#ae ,u4,s4,c4 #bfbg7 is   
am5d$ by /rik+ subsections 7c7 & 7d74   
#bb4 ,au?orization ( appropriations     
,section #bi 7#ae ,u4,s4,c4 #bfbh7 is   
repeal$4  #bc4 ,annual report ,section  
#cj 7#ae ,u4,s4,c4 #bfbi7 is am5d$ by   
/rik+ p>agraph 7#b7 & ins]t+ ! foll[+3  
7#b7 7,a7 ! numb] ( notices receiv$ dur+
 ea* ye> "u section #e2 &  7,b7 ! numb] 
( ! notices describ$ 9 subp>agraph 7,a7 
= *emical sub/ances subject to a rule1  
te/+ cons5t agreem5t1 or ord] "u section

 #d7;f72  4