,,ii ,cal5d> ,no4 #aba #aad? ,,congress #a/ ,session ,s4 #fig ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #aj1 #bjae,mr4 ,udall 7= himself1 ,mr4 ,vitt]1 ,mr4 ,man*91 ,mr4 ,inh(e1 ,mr4 ,c>p]1 ,mr4 ,blunt1 ,mr4 ,coons1 ,mr4 ,boozman1 ,mr4 ,donnelly1 ,mrs4 ,capito1 ,mr4 ,he9ri*1 ,mr4 ,cassidy1 ,ms4 ,heitkamp1 ,mr4 ,crapo1 ,ms4 ,/ab5[1 ,mr4 ,hoev51 ,mr4 ,portman1 ,mr4 ,w>n]1 ,mr4 ,pet]s1 ,mr4 ,r\nds1 ,mr4 ,br[n1 ,mr4 ,?une1 ,mr4 ,b>rasso1 ,mr4 ,book]1 ,mr4 ,cornyn1 ,mr4 ,cotton1 ,mr4 ,isakson1 ,mr4 ,ka9e1 ,mrs4 ,mc,caskill1 ,mr4 ,m]kley1 ,ms4 ,murk[ski1 ,mr4 ,murphy1 ,mr4 ,rubio1 ,mr4 ,scott1 ,mrs4 ,%ahe51 ,mr4 ,:iteh\se1 ,mr4 ,casey1 ,mr4 ,p]due1 ,ms4 ,klobu*>1 ,mr4 ,coats1 & ,mr4 ,toomey7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,environm5t & ,public ,works ,june #ag1 #bjae,report$ by ,mr4 ,inh(e1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to am5d ! ,toxic ,sub/ances ,control ,act to reau?orize & mod]nize t ,act1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 #b4 ,f9d+s1 policy1 & int5t ,section #b7;c7 ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja7;c77 is am5d$-- 7#a7 by /rik+ ,x is ! int5t & ins]t+ ! foll[+3 7#a7 ,adm9i/ration ,x is ! int5t 2 7#b7 9 p>agraph 7#a7 7z s r$esignat$71 by ins]t+ 1 z provid$ "u ?is ,act be=e ! p]iod at ! end2 & 7#c7 by add+ at ! foll[+3 7#b7 ,re=m ,x is ! int5t ( ,congress t re=m ( ?is ,act 9 accordance ) ! am5dm5ts made by ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act-- 7,a7 %all be adm9i/]$ 9 a mann] t-- 7i7 protects ! heal? ( *ildr51 pregnant wom51 ! eld]ly1 work]s1 consum]s1 ! g5]al public1 & ! environm5t f ! risks ( h>mful exposures to *emical sub/ances & mixtures2 & 7ii7 ensures t appropriate in=mation on *emical sub/ances & mixtures is available to public heal? (ficials & fir/ respond]s 9 ! ev5t ( an em]g5cy2 & 7,b7 %all n displace or supplant common law rights ( action or rem$ies = civil relief4 4 #c4 ,def9itions ,section #c ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjb7 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#d71 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 7#ac71 & 7#ad7 z p>agraphs 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#ab71 7#ac71 7#ag71 7#ah71 & 7#ai71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,conditions ( use ,! t]m conditions ( use means ! int5d$1 kn[n1 or reasonably =eseeable circum/ances ! ,adm9i/rator det]m9es a *emical sub/ance is manufactur$1 process$1 di/ribut$ 9 comm]ce1 us$1 or dispos$ (4 2 7#c7 by ins]t+ aft] p>agraph 7#aj7 7z s r$esignat$7 ! foll[+3 7#aa7 ,pot5tially expos$ or susceptible population ,! t]m pot5tially expos$ or susceptible population means #a or m gr\ps-- 7,a7 ( individuals )9 ! g5]al population :o may be-- 7i7 diff]5tially expos$ to *emical sub/ances "u ! conditions ( use2 or 7ii7 susceptible to great] adv]se heal? consequ5ces f *emical exposures ?an ! g5]al population2 & 7,b7 t :5 id5tifi$ by ! ,adm9i/rator may include su* gr\ps z infants1 *ildr51 pregnant wom51 work]s1 & ! eld]ly4 2 & 7#d7 by ins]t+ aft] p>agraph 7#ac7 7z s r$esignat$7 ! foll[+3 7#ad7 ,safety assessm5t ,! t]m safety assessm5t means an assessm5t ( ! risk pos$ by a *emical sub/ance "u ! conditions ( use1 integrat+ haz>d1 use1 & exposure in=mation reg>d+ ! *emical sub/ance4 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 ! conditions ( use4 7#af7 ,safety /&>d ,! t]m safety /&>d means a /&>d t ensures1 )\t tak+ into consid]ation co/ or o!r nonrisk factors1 t no unreasonable risk ( h>m to heal? or ! environm5t w result f exposure to a *emical sub/ance "u ! conditions ( use1 includ+ no unreasonable risk ( h>m to-- 7,a7 ! g5]al population2 or 7,b7 any pot5tially expos$ or susceptible population t ! ,adm9i/rator has id5tifi$ z relevant to ! safety assessm5t & safety det]m9ation = a *emical sub/ance4 4 #d4 ,policies1 proc$ures1 & guidance ,! ,toxic ,sub/ances ,control ,act is am5d$ by ins]t+ aft] section #c 7#ae ,u4,s4,c4 #bfjb7 ! foll[+3 #c;,a4 ,policies1 proc$ures1 & guidance 7a7 ,def9ition ( guidance ,9 ?is section1 ! t]m guidance includes any significant writt5 guidance ( g5]al applicability prep>$ by ! ,adm9i/rator4 7b7 ,deadl9e ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator %all develop1 aft] provid+ public notice & an opportunity = comm5t1 any policies1 proc$ures1 & guidance ! ,adm9i/rator det]m9es to be necess>y to c>ry out sections #d1 #d;,a1 #e1 & #f1 includ+ ! policies1 proc$ures1 & guidance requir$ by ?is section4 7c7 ,use ( sci5ce 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% policies1 proc$ures1 & guidance on ! use ( sci5ce 9 mak+ decisions "u sections #d1 #d;,a1 #e1 & #f4 7#b7 ,goal ,a goal ( ! policies & proc$ures describ$ 9 p>agraph 7#a7 %all be to make ! basis ( decisions cle> to ! public4 7#c7 ,requirem5ts ,! policies1 proc$ures1 & guidance issu$ "u ?is section %all describe ! mann] 9 :i* ! ,adm9i/rator %all ensure t-- 7,a7 decisions made by ! ,adm9i/rator-- 7i7 are bas$ on in=mation1 proc$ures1 measures1 me?ods1 & models employ$ 9 a mann] consi/5t ) ! be/ available sci5ce2 7ii7 take into acc\nt ! ext5t to :i*-- 7,i7 assumptions & me?ods are cle>ly & completely describ$ & docum5t$2 7,,ii7 v>iability & unc]ta9ty are evaluat$ & *>act]iz$2 & 7,,iii7 ! in=mation has be5 subject to indep5d5t v]ification & pe] review2 & 7iii7 are bas$ on ! weight ( ! sci5tific evid5ce1 by :i* ! ,adm9i/rator consid]s all in=mation 9 a sy/ematic & integrative framework to consid] ! relevance ( diff]5t in=mation2 7,b7 to ! ext5t practicable & if appropriate1 ! use ( pe] review1 /&>diz$ te/ design & me?ods1 consi/5t data evaluation proc$ures1 & good laboratory practices w be enc\rag$2 7,c7 a cle> description ( ea* individual & entity t fund$ ! g5]ation or assessm5t ( in=mation1 & ! degree ( control ^? individuals & entities _h ov] ! g5]ation1 assessm5t1 & dissem9ation ( in=mation 7includ+ control ov] ! design ( ! "w & ! publication ( in=mation7 is made available2 & 7,d7 if appropriate1 ! recomm5dations 9 reports ( ! ,national ,academy ( ,sci5ces t provide advice reg>d+ assess+ ! haz>ds1 exposures1 & risks ( *emical sub/ances are consid]$4 7d7 ,exi/+ ,,epa policies1 proc$ures1 & guidance ,! policies1 proc$ures1 & guidance describ$ 9 subsection 7b7 %all incorporate1 z appropriate1 exi/+ relevant haz>d1 exposure1 & risk assessm5t guidel9es & me?odologies1 data evaluation & quality crit]ia1 te/+ me?odologies1 & o!r relevant guidel9es & policies ( ! ,environm5tal ,protection ,ag5cy4 7e7 ,review ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ?is section1 & n less frequ5tly ?an once e #e ye>s !reaft]1 ! ,adm9i/rator %all-- 7#a7 review ! adequacy ( any policies1 proc$ures1 & guidance develop$ "u ?is section1 includ+ animal1 nonanimal1 & epidemiological te/ me?ods & proc$ures = assess+ & det]m9+ risk "u ?is ,act2 & 7#b7 aft] provid+ public notice & an opportunity = comm5t1 revise ! policies1 proc$ures1 & guidance if necess>y to reflect new sci5tific developm5ts or und]/&+s4 7f7 ,s\rces ( in=mation ,9 mak+ any decision ) respect to a *emical sub/ance "u section #d1 #d;,a1 #e1 or #f1 ! ,adm9i/rator %all take into consid]ation in=mation relat+ to ! haz>ds & exposures ( a *emical sub/ance "u ! conditions ( use t is reasonably available to ! ,adm9i/rator1 includ+ in=mation t is-- 7#a7 submitt$ to ! ,adm9i/rator pursuant to any rule1 cons5t agreem5t1 ord]1 or o!r requirem5t ( ?is ,act1 or on a volunt>y basis1 includ+ pursuant to any reque/ made "u ?is ,act1 by-- 7,a7 manufactur]s or processors ( a sub/ance2 7,b7 ! public2 7,c7 o!r ,f$]al dep>tm5ts or ag5cies2 or 7,d7 ! ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? or ! environm5t2 7#b7 submitt$ to a gov]nm5tal entity 9 any jurisdiction pursuant to a gov]nm5tal requirem5t relat+ to ! protection ( heal? or ! environm5t2 or 7#c7 id5tifi$ ?r\gh an active se>* by ! ,adm9i/rator ( in=mation s\rces t are publicly available or o!rwise accessible by ! ,adm9i/rator4 7g7 ,te/+ ( *emical sub/ances & mixtures 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% policies & proc$ures = ! te/+ ( *emical sub/ances or mixtures "u section #d4 7#b7 ,goal ,a goal ( ! policies & proc$ures e/abli%$ "u p>agraph 7#a7 %all be to make ! basis ( decisions cle> to ! public4 7#c7 ,cont5ts ,! policies & proc$ures e/abli%$ "u p>agraph 7#a7 %all-- 7,a7 address h[ & :5 ! exposure level or exposure pot5tial ( a *emical sub/ance w\ld factor into decisions to require new te/+1 subject to ! condition t ! ,adm9i/rator %all n int]pret ! lack ( exposure in=mation z a lack ( exposure or exposure pot5tial2 7,b7 describe ! mann] 9 :i* ! ,adm9i/rator w det]m9e t additional in=mation is necess>y to c>ry out ?is ,act1 includ+ in=mation relat+ to pot5tially expos$ or susceptible populations2 7,c7 require ! ,adm9i/rator to consult ) ! ,director ( ! ,national ,in/itute = ,occupational ,safety & ,heal? prior to prescrib+ epidemiologic /udies ( employees2 & 7,d7 prior to adopt+ a requirem5t = te/+ us+ v]tebrate animals1 require ! ,adm9i/rator to take into consid]ation1 z appropriate & to ! ext5t practicable1 reasonably available-- 7i7 toxicity in=mation2 7ii7 computational toxicology & bio9=matics2 7iii7 high-?r\ghput scre5+ me?ods & ! pr$iction models ( ^? me?ods2 & 7iv7 sci5tifically reliable & relevant alt]natives to te/s on animals t w\ld provide equival5t in=mation4 7#d7 ,ti]$ te/+ 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,d71 ! ,adm9i/rator %all employ a ti]$ scre5+ & te/+ process1 "u :i* ! results ( scre5+-level te/s or assessm5ts ( available in=mation in=m ! decision z to :e!r #a or m additional te/s are necess>y4 7,b7 ,scre5+-level te/s 7i7 ,9 g5]al ,! scre5+-level te/s requir$ = a *emical sub/ance or mixture may include te/s = haz>d 7:i* may include 9 silico1 9 vitro1 & 9 vivo te/s71 environm5tal & biological fate & transport1 & measurem5ts or model+ ( exposure or exposure pot5tial1 z appropriate4 7ii7 ,use ,scre5+-level te/s %all be us$-- 7,i7 to scre5 *emical sub/ances or mixtures = pot5tial adv]se effects2 & 7,,ii7 to in=m a decision ( ! ,adm9i/rator reg>d+ :e!r m complex or t>get$ additional te/+ is necess>y4 7,c7 ,additional te/+ ,if ! ,adm9i/rator det]m9es "u subp>agraph 7,b7 t additional te/+ is necess>y to provide m def9itive in=mation = safety assessm5ts or safety det]m9ations1 ! ,adm9i/rator may require m advanc$ te/s = pot5tial heal? or environm5tal effects or exposure pot5tial4 7,d7 ,advanc$ te/+ )\t scre5+ ,! ,adm9i/rator may require m advanc$ te/+ )\t conduct+ scre5+-level te/+ :5 o!r in=mation available to ! ,adm9i/rator ju/ifies ! advanc$ te/+1 pursuant to guidance develop$ by ! ,adm9i/rator "u ?is section4 7h7 ,safety assessm5ts & safety det]m9ations 7#a7 ,s*$ule 7,a7 ,9 g5]al ,! ,adm9i/rator %all in=m ! public reg>d+ ! s*$ule = ! completion ( ea* safety assessm5t & safety det]m9ation z soon z practicable aft] designation z a high-priority sub/ance pursuant to section #d;,a4 7,b7 ,diff]+ times ,! ,adm9i/rator may allot diff]5t times = diff]5t *emical sub/ances 9 ! s*$ules "u ?is p>agraph1 subject to ! condition t all s*$ules %all comply ) ! deadl9es e/abli%$ "u section #f4 7,c7 ,annual plan ,at ! beg9n+ ( ea* cal5d> ye>1 ! ,adm9i/rator %all id5tify ! sub/ances subject to safety assessm5ts & safety det]m9ations to be complet$ t ye>4 7#b7 ,policies & proc$ures = safety assessm5ts & safety det]m9ations 7,a7 ,9 g5]al ,! ,adm9i/rator %all e/abli%1 by rule1 policies & proc$ures reg>d+ ! mann] 9 :i* ! ,adm9i/rator %all c>ry out section #f4 7,b7 ,goal ,a goal ( ! policies & proc$ures "u ?is p>agraph %all be to make ! basis ( decisions ( ! ,adm9i/rator cle> to ! public4 7,c7 ,m9imum requirem5ts ,at a m9imum1 ! policies & proc$ures "u ?is p>agraph %all-- 7i7 describe-- 7,i7 ! mann] 9 :i* ! ,adm9i/rator w id5tify in=mational ne$s & seek t in=mation f ! public2 7,,ii7 ! in=mation 7includ+ draft safety assessm5ts7 t may be submitt$ by int]e/$ individuals or entities1 includ+ ,/ates2 & 7,,iii7 ! crit]ia by :i* t in=mation w be evaluat$2 7ii7 require ! ,adm9i/rator-- 7,i7 7aa7 to def9e ! scope ( ! safety assessm5t & safety det]m9ation to be conduct$ "u section #f1 includ+ ! haz>ds1 exposures1 conditions ( use1 & pot5tially expos$ & susceptible populations t ! ,adm9i/rator expects to consid] 9 a safety assessm5t2 7bb7 to expla9 ! basis = ! scope ( ! safety assessm5t & safety det]m9ation2 & 7cc7 to accept comm5ts reg>d+ ! scope ( ! safety assessm5t & safety det]m9ation2 & 7,,ii7 7aa7 to id5tify ! items describ$ 9 subclause 7,i7 t ! ,adm9i/rator has consid]$ 9 ! f9al safety assessm5t2 & 7bb7 to expla9 ! basis = ! consid]ation ( ^? items2 7iii7 describe ! mann] 9 :i* aggregate exposures1 or significant subsets ( exposures1 to a *emical sub/ance "u ! conditions ( use w be consid]$1 & expla9 ! basis = t consid]ation 9 ! f9al safety assessm5t2 7iv7 require t ea* safety assessm5t & safety det]m9ation %all include-- 7,i7 a description ( ! weight ( ! sci5tific evid5ce ( risk2 & 7,,ii7 a summ>y ( ! in=mation reg>d+ ! impact on heal? & ! environm5t ( ! *emical sub/ance t 0 us$ to make ! assessm5t or det]m9ation1 includ+1 z available1 me*ani/ic1 animal toxicity1 & epidemiology /udies2 7v7 e/abli% a timely & transp>5t process = evaluat+ :e!r new in=mation submitt$ or obta9$ aft] ! date ( a f9al safety assessm5t or safety det]m9ation w>rants reconsid]ation ( ! safety assessm5t or safety det]m9ation2 & 7vi7 :5 relevant in=mation is provid$ or o!rwise made available to ! ,adm9i/rator1 %all consid] ! ext5t ( ,f$]al regulation "u o!r ,f$]al laws4 7,d7 ,guidance 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator %all develop guidance to assi/ int]e/$ p]sons 9 develop+ draft safety assessm5ts & o!r in=mation = submission to ! ,adm9i/rator1 :i* may be consid]$ at ! discretion ( ! ,adm9i/rator4 7ii7 ,requirem5t ,! guidance %all1 at a m9imum1 address ! quality ( ! in=mation submitt$ & ! process to be foll[$ 9 develop+ a draft assessm5t = consid]ation by ! ,adm9i/rator4 7#c7 ,articles ,if ! ,adm9i/rator int5ds to prohibit or o!rwise re/rict an article on ! basis ( a *emical sub/ance conta9$ 9 t article1 ! ,adm9i/rator %all h evid5ce ( significant exposure to ! *emical sub/ance f su* article4 7i7 ,publicly available in=mation ,subject to section #ad1 ! ,adm9i/rator %all-- 7#a7 make publicly available a nonte*nical summ>y1 & ! f9al v]sion1 ( ea* safety assessm5t & safety det]m9ation2 7#b7 provide public notice & an opportunity = comm5t on ea* propos$ safety assessm5t & safety det]m9ation2 & 7#c7 make public 9 a f9al safety assessm5t & safety det]m9ation-- 7,a7 ! li/ ( /udies consid]$ by ! ,adm9i/rator 9 c>ry+ out ! safety assessm5t or safety det]m9ation2 & 7,b7 ! li/ ( policies1 proc$ures1 & guidance t 7 foll[$ 9 c>ry+ out ! safety assessm5t or safety det]m9ation4 7j7 ,consultation ) ,sci5ce ,advisory ,committee on ,*emicals 7#a7 ,e/abli%m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,adm9i/rator %all e/abli% an advisory committee1 to be kn[n z ! ,sci5ce ,advisory ,committee on ,*emicals 7ref]r$ to 9 ?is subsection z ! ,committee74 7#b7 ,purpose ,! purpose ( ! ,committee %all be to provide indep5d5t advice & exp]t consultation1 on ! reque/ ( ! ,adm9i/rator1 ) respect to ! sci5tific & te*nical aspects ( issues relat+ to ! implem5tation ( ?is title4 7#c7 ,composition ,! ,committee %all be compos$ ( repres5tatives ( su* sci5ce1 gov]nm5t1 labor1 public heal?1 public int]e/1 animal protection1 indu/ry1 & o!r gr\ps z ! ,adm9i/rator det]m9es to be advisable1 includ+1 at a m9imum1 repres5tatives t h specific sci5tific exp]tise 9 ! relation%ip ( *emical exposures to wom51 *ildr51 & o!r pot5tially expos$ or susceptible populations4 7#d7 ,s*$ule ,! ,adm9i/rator %all conv5e ! ,committee 9 accordance ) su* s*$ule z ! ,adm9i/rator det]m9es to be appropriate1 b n less frequ5tly ?an once e #b ye>s4 7#e7 ,relation%ip to o!r law ,all proce$+s & meet+s ( ! ,committee %all be subject to ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 4 #e4 ,te/+ ( *emical sub/ances or mixtures 7a7 ,9 g5]al ,section #d ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjc7 is am5d$-- 7#a7 by /rik+ subsections 7a71 7b71 7c71 7d71 & 7g72 7#b7 by r$esignat+ subsections 7e7 & 7f7 z subsections 7f7 & 7g71 respectively2 7#c7 9 subsection 7f7 7z s r$esignat$7-- 7,a7 by /rik+ rule ea* place x appe>s & ins]t+ rule1 te/+ cons5t agreem5t1 or ord]2 7,b7 by /rik+ "u subsection 7a7 ea* place x appe>s & ins]t+ "u ?is subsection2 & 7,c7 9 p>agraph 7#a77;,b71 9 ! la/ s5t5ce1 by /rik+ rulemak+2 7#d7 9 subsection 7g7 7z s r$esignat$7-- 7,a7 9 ! fir/ s5t5ce1 by /rik+ f canc]1 g5e mutations1 or bir? defects2 & 7,b7 by /rik+ ! la/ s5t5ce2 & 7#e7 by ins]t+ be=e subsection 7f7 7z s r$esignat$7 ! foll[+3 7a7 ,developm5t ( new in=mation on *emical sub/ances & mixtures 7#a7 ,9 g5]al ,! ,adm9i/rator may require ! developm5t ( new in=mation relat+ to a *emical sub/ance or mixture 9 accordance ) ?is section if ! ,adm9i/rator det]m9es t ! in=mation is necess>y-- 7,a7 to review a notice "u section #e7;d7 or to p]=m a safety assessm5t or safety det]m9ation "u section #f2 7,b7 to implem5t a requirem5t impos$ 9 a cons5t agreem5t or ord] issu$ "u section #e7;d77#d7 or "u a rule promulgat$ "u section #f7;d77#c72 7,c7 pursuant to section #ab7;a77#d72 or 7,d7 at ! reque/ ( ! implem5t+ au?ority "u ano!r ,f$]al law1 to meet ! regulatory te/+ ne$s ( t au?ority4 7#b7 ,limit$ te/+ = prioritization purposes 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! ,adm9i/rator may require ! developm5t ( new in=mation = ! purposes ( section #d;,a4 7,b7 ,prohibition ,te/+ requir$ "u subp>agraph 7,a7 %all n be requir$ = ! purpose ( e/abli%+ or implem5t+ a m9imum in=mation requirem5t4 7,c7 ,limitation ,! ,adm9i/rator may require ! developm5t ( new in=mation pursuant to subp>agraph 7,a7 only if ! ,adm9i/rator det]m9es t additional in=mation is necess>y to e/abli% ! priority ( a *emical sub/ance4 7#c7 ,=m ,subject to section #c;,a7h71 ! ,adm9i/rator may require ! developm5t ( in=mation describ$ 9 p>agraph 7#a7 or 7#b7 by-- 7,a7 promulgat+ a rule2 7,b7 ent]+ into a te/+ cons5t agreem5t2 or 7,c7 issu+ an ord]4 7#d7 ,cont5ts 7,a7 ,9 g5]al ,a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u ?is subsection %all include-- 7i7 id5tification ( ! *emical sub/ance or mixture = :i* te/+ is requir$2 7ii7 id5tification ( ! p]sons requir$ to conduct ! te/+2 7iii7 te/ protocols & me?odologies = ! developm5t ( te/ data & in=mation = ! *emical sub/ance or mixture1 includ+ specific ref]5ce to reliable nonanimal te/ proc$ures2 & 7iv7 specification ( ! p]iod )9 :i* individuals & entities requir$ to conduct ! te/+ %all submit to ! ,adm9i/rator ! in=mation develop$ 9 accordance ) ! proc$ures describ$ 9 clause 7iii74 7,b7 ,consid]ations ,9 det]m9+ ! proc$ures & p]iod to be requir$ "u subp>agraph 7,a71 ! ,adm9i/rator %all take into consid]ation-- 7i7 ! relative co/s ( ! v>i\s te/ protocols & me?odologies t may be requir$2 & 7ii7 ! reasonably =eseeable availability ( facilities & p]sonnel requir$ to p]=m ! te/+4 7b7 ,/atem5t ( ne$ 7#a7 ,9 g5]al ,9 promulgat+ a rule1 ent]+ into a te/+ cons5t agreem5t1 or issu+ an ord] = ! developm5t ( additional in=mation 7includ+ in=mation on exposure or exposure pot5tial7 pursuant to ?is section1 ! ,adm9i/rator %all-- 7,a7 id5tify ! ne$ int5d$ to be met by ! rule1 agreem5t1 or ord]2 7,b7 expla9 :y in=mation reasonably available to ! ,adm9i/rator at t "t is inadequate to meet t ne$1 includ+ a ref]5ce1 z appropriate1 to ! in=mation id5tifi$ 9 p>agraph 7#b77;,b72 & 7,c7 expla9 ! basis = any decision t requires ! use ( v]tebrate animals4 7#b7 ,explanation 9 case ( ord] 7,a7 ,9 g5]al ,if ! ,adm9i/rator issues an ord] "u ?is section1 ! ,adm9i/rator %all issue a /atem5t provid+ a ju/ification = :y issuance ( an ord] is w>rant$ 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 description (-- 7i7 in=mation t is readily accessible to ! ,adm9i/rator1 includ+ in=mation submitt$ "u any o!r provision ( law2 7ii7 ! ext5t to :i* ! ,adm9i/rator has obta9$ or attempt$ to obta9 ! in=mation ?r\gh volunt>y submissions2 & 7iii7 any in=mation reli$ on 9 safety assessm5ts = o!r *emical sub/ances relevant to ! *emical sub/ances t w\ld be ! subject ( ! ord]4 7c7 ,r$uction ( te/+ on v]tebrates 7#a7 ,9 g5]al ,! ,adm9i/rator %all m9imize1 to ! ext5t practicable1 ! use ( v]tebrate animals 9 te/+ ( *emical sub/ances or mixtures1 by-- 7,a7 enc\rag+ & facilitat+-- 7i7 ! use ( integrat$ & ti]$ te/+ & assessm5t /rategies2 7ii7 ! use ( be/ available sci5ce 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+ 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 in=mation on o!r *emical sub/ances 9 ! category2 7v7 ! =mation ( indu/ry consortia to jo9tly conduct te/+ to avoid unnecess>y duplication ( te/s2 & 7vi7 ! submission ( in=mation f-- 7,i7 animal-bas$ /udies2 & 7,,ii7 em]g+ me?ods & models2 & 7,b7 fund+ rese>* & validation /udies to r$uce1 ref9e1 & replace ! use ( animal te/s 9 accordance ) ?is subsection4 7#b7 ,implem5tation ( alt]native te/+ me?ods ,to promote ! developm5t & timely incorporation ( new te/+ me?ods t are n bas$ on v]tebrate animals1 ! ,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 "u ?is title t c r$uce1 ref9e1 or replace ! use ( v]tebrate animals1 includ+ toxicity pa?way-bas$ risk assessm5t1 9 vitro /udies1 sy/ems biology1 computational toxicology1 bio9=matics1 & high-?r\ghput scre5+2 7,b7 z practicable1 ensure t ! /rategic plan develop$ "u subp>agraph 7,a7 is reflect$ 9 ! developm5t ( requirem5ts = te/+ "u ?is section2 7,c7 beg9n+ on ! date t is #e ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act & e #e ye>s !reaft]1 submit to ,congress a report t describes ! progress made 9 implem5t+ ?is subsection & goals = future alt]native te/ me?ods implem5tation2 & 7,d7 fund & c>ry out rese>*1 developm5t1 p]=mance assessm5t1 & translational /udies to accel]ate ! developm5t ( te/ me?ods & te/+ /rategies t r$uce1 ref9e1 or replace ! use ( v]tebrate animals 9 any te/+ "u ?is title4 7#c7 ,crit]ia = adapt+ or waiv+ animal te/+ requirem5ts ,on reque/ f a manufactur] or processor t is requir$ to conduct te/+ ( a *emical sub/ance or mixture on v]tebrate animals "u ?is section1 ! ,adm9i/rator may adapt or waive ! requirem5t1 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 z a result ( #a or m physical or *emical prop]ties ( ! *emical sub/ance or mixture or o!r toxicok9etic consid]ations-- 7i7 ! sub/ance _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 v]tebrate 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 7d7 ,te/+ requirem5ts 7#a7 ,9 g5]al ,! ,adm9i/rator may require ! developm5t ( in=mation by-- 7,a7 manufactur]s & processors ( ! *emical sub/ance or mixture2 & 7,b7 p]sons t beg9 to manufacture or process ! *emical sub/ance or mixture-- 7i7 aft] ! effective date ( ! rule1 te/+ cons5t agreem5t1 or ord]2 b 7ii7 subject to p>agraph 7#c71 be=e ! p]iod end+ on ! date t is #ahj days aft] ! end ( ! p]iod describ$ 9 ?is section4 7#b7 ,designation ,! ,adm9i/rator may p]mit #b or m p]sons id5tifi$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 to designate #a ( ! p]sons or a qualifi$ ?ird p>ty-- 7,a7 to develop ! in=mation2 & 7,b7 to submit ! in=mation on behalf ( ! p]sons mak+ ! designation4 7#c7 ,exemptions 7,a7 ,9 g5]al ,a p]son o!rwise subject to a rule1 te/+ cons5t agreem5t1 or ord] "u ?is section may submit to ! ,adm9i/rator an application = an exemption on ! basis t ! in=mation is be+ develop$ by a p]son designat$ "u p>agraph 7#b74 7,b7 ,fair & equitable reimbursem5t to designee 7i7 ,9 g5]al ,if ! ,adm9i/rator accepts an application submitt$ "u subp>agraph 7,a71 ! ,adm9i/rator %all direct ! applicant to provide to ! p]son designat$ "u p>agraph 7#b7 fair & equitable reimbursem5t1 z agre$ to betwe5 ! applicant & ! designee4 7ii7 ,arbitration ,if ! applicant & a p]son designat$ "u p>agraph 7#b7 _c rea* agreem5t on ! am\nt ( fair & equitable reimbursem5t1 ! am\nt %all be det]m9$ by arbitration4 7,c7 ,t]m9ation ,if1 aft] grant+ an exemption "u ?is p>agraph1 ! ,adm9i/rator det]m9es t a p]son cov]$ by ! exemption has fail$ to comply ) ! rule1 te/+ cons5t agreem5t1 or ord]1 ! ,adm9i/rator %all-- 7i7 by ord]1 t]m9ate ! exemption2 & 7ii7 notify 9 writ+ ea* p]son t receiv$ an exemption ( ! requirem5ts ) respect to :i* ! exemption 0 grant$4 7e7 ,transp>5cy ,subject to section #ad1 ! ,adm9i/rator %all make available to ! public all te/+ cons5t agreem5ts & ord]s & all in=mation submitt$ "u ?is section4 4 7b7 ,con=m+ am5dm5t ,section #ajd7;i77#e77;,a7 ( ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act ( #aihj 7#db ,u4,s4,c4 #ifjd7;i77#e77;,a77 is am5d$ 9 ! ?ird s5t5ce by /rik+ section #d7;e7 & ins]t+ section #d7;f74 #f4 ,prioritization scre5+ ,! ,toxic ,sub/ances ,control ,act is am5d$ by ins]t+ aft] section #d 7#ae ,u4,s4,c4 #bfjc7 ! foll[+3 #d;,a4 ,prioritization scre5+ 7a7 ,e/abli%m5t & li/ ( sub/ances 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,adm9i/rator %all e/abli%1 by rule1 a risk-bas$ scre5+ process & explicit crit]ia = id5tify+ exi/+ *emical sub/ances t are-- 7,a7 a high priority = a safety assessm5t & safety det]m9ation "u section #f 7ref]r$ to 9 ?is ,act z high-priority sub/ances72 & 7,b7 a l[ priority = a safety assessm5t & safety det]m9ation 7ref]r$ to 9 ?is ,act z l[-priority sub/ances74 7#b7 ,initial li/ ( high- & l[-priority sub/ances 7,a7 ,9 g5]al ,be=e ! date ( promulgation ( ! rule "u p>agraph 7#a7 & n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is section1 ! ,adm9i/rator-- 7i7 %all take into consid]ation & publi% an initial li/ ( high-priority sub/ances & l[-priority sub/ances2 & 7ii7 pursuant to section #f7;b71 may initiate or cont9ue safety assessm5ts & safety det]m9ations = ^? high-priority sub/ances4 7,b7 ,requirem5ts 7i7 ,9 g5]al ,! initial li/ ( *emical sub/ances %all conta9 at lea/ #aj high-priority sub/ances1 at lea/ #e ( :i* are drawn f ! li/ ( *emical sub/ances id5tifi$ by ! ,adm9i/rator 9 ! ,octob]1 #bjad ,,tsca ,"w ,plan & subsequ5t updates1 & at lea/ #aj l[-priority sub/ances4 7ii7 ,subsequ5tly id5tifi$ sub/ances ,ins(> z possible1 at lea/ #ej p]c5t ( all sub/ances subsequ5tly id5tifi$ by ! ,adm9i/rator z high-priority sub/ances %all be drawn f ! li/ ( *emical sub/ances id5tifi$ by ! ,adm9i/rator 9 ! ,octob]1 #bjad ,,tsca ,"w ,plan & subsequ5t updates1 until all ,"w ,plan *emicals h be5 designat$ "u ?is subsection4 7,c7 ,additional *emical reviews ,! ,adm9i/rator %all-- 7i7 #c ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 add additional high-priority sub/ances suffici5t to ensure t at lea/ a total ( #bj high-priority sub/ances h und]gone or are und]go+ ! process e/abli%$ 9 section #f7;a71 & additional l[-priority sub/ances suffici5t to ensure t at lea/ a total ( #bj l[-priority sub/ances h be5 designat$2 & 7ii7 z soon z practicable & n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 add additional high-priority sub/ances suffici5t to ensure t at lea/ a total ( #be high-priority sub/ances h und]gone or are und]go+ ! process e/abli%$ 9 section #f7;a71 & additional l[-priority sub/ances suffici5t to ensure t at lea/ a total ( #be l[-priority sub/ances h be5 designat$4 7#c7 ,implem5tation 7,a7 ,consid]ation ( active & inactive sub/ances 7i7 ,active sub/ances ,9 c>ry+ out p>agraph 7#a71 ! ,adm9i/rator %all take into consid]ation active sub/ances1 z det]m9$ "u section #h1 :i* may include *emical sub/ances on ! int]im li/ ( active sub/ances e/abli%$ "u t section4 7ii7 ,inactive sub/ances ,9 c>ry+ out p>agraph 7#a71 ! ,adm9i/rator may take into consid]ation inactive sub/ances1 z det]m9$ "u section #h1 t ! ,adm9i/rator det]m9es-- 7,i7 7aa7 h n be5 subject to a regulatory or o!r en=ceable action by ! ,adm9i/rator to ban or phase out ! sub/ances2 & 7bb7 h ! pot5tial = high haz>d & widespread exposure2 or 7,,ii7 7aa7 h be5 subject to a regulatory or o!r en=ceable action by ! ,adm9i/rator to ban or phase out ! sub/ances2 & 7bb7 ) respect to :i* !re exi/s ! pot5tial = residual high haz>ds or widespread exposures n o!rwise address$ by ! regulatory or o!r action4 7iii7 ,repopulation 7,i7 ,9 g5]al ,on ! completion ( a safety det]m9ation "u section #f = a *emical sub/ance1 ! ,adm9i/rator %all remove ! *emical sub/ance f ! li/ ( high-priority sub/ances e/abli%$ "u ?is subsection4 7,,ii7 ,additions ,! ,adm9i/rator %all add at lea/ #a *emical sub/ance to ! li/ ( high-priority sub/ances = ea* *emical sub/ance remov$ f ! li/ ( high-priority sub/ances e/abli%$ "u ?is subsection1 until a safety assessm5t & safety det]m9ation is complet$ = all high-priority sub/ances4 7,,iii7 ,l[-priority sub/ances ,if a l[-priority sub/ance is subsequ5tly designat$ z a high-priority sub/ance1 ! ,adm9i/rator %all remove t sub/ance f ! li/ ( l[-priority sub/ances4 7,b7 ,timely completion ( prioritization scre5+ process 7i7 ,9 g5]al ,! ,adm9i/rator %all-- 7,i7 n lat] ?an #ahj days aft] ! effective date ( ! f9al rule "u p>agraph 7#a71 beg9 ! prioritization scre5+ process2 & 7,,ii7 make e ef=t to complete ! designation ( all active sub/ances z high-priority sub/ances or l[-priority sub/ances 9 a timely mann]4 7ii7 ,decisions on sub/ances subject to te/+ = prioritization purposes ,n lat] ?an #ij days aft] ! date ( receipt ( in=mation reg>d+ a *emical sub/ance comply+ ) a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u section #d7;a77#b71 ! ,adm9i/rator %all designate ! *emical sub/ance z a high-priority sub/ance or l[-priority sub/ance4 7iii7 ,consid]ation 7,i7 ,9 g5]al ,! ,adm9i/rator %all scre5 sub/ances & designate high-priority sub/ances tak+ into consid]ation ! ability ( ! ,adm9i/rator to s*$ule & complete safety assessm5ts & safety det]m9ations "u section #f 9 a timely mann]4 7,,ii7 ,annual goal ,! ,adm9i/rator %all publi% an annual goal = ! numb] ( *emical sub/ances to be subject to ! prioritization scre5+ process4 7,c7 ,scre5+ ( categories ( sub/ances ,! ,adm9i/rator may scre5 categories ( *emical sub/ances to ensure an effici5t prioritization scre5+ process to all[ = timely & adequate designations ( high-priority sub/ances & l[-priority sub/ances & safety assessm5ts & safety det]m9ations = high-priority sub/ances4 7,d7 ,publication ( li/ ( *emical sub/ances ,n less frequ5tly ?an once ea* ye>1 ! ,adm9i/rator %all publi% a li/ ( *emical sub/ances t-- 7i7 are be+ consid]$ 9 ! prioritization scre5+ process & ! /atus ( ! *emical sub/ances 9 ! prioritization process1 includ+ ^? *emical sub/ances = :i* prioritization decisions h be5 def]r$2 & 7ii7 are designat$ z high-priority sub/ances or l[-priority sub/ances1 includ+ ! bases = su* designations4 7#d7 ,crit]ia ,! crit]ia describ$ 9 p>agraph 7#a7 %all acc\nt =-- 7,a7 ! recomm5dation ( ! ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? or ! environm5t f *emical sub/ances appropriate = prioritization scre5+2 7,b7 ! haz>d & exposure pot5tial ( ! *emical sub/ance 7or category ( sub/ances71 includ+ specific sci5tific classifications & designations by au?oritative gov]nm5tal entities2 7,c7 ! conditions ( use or significant *anges 9 ! conditions ( use ( ! *emical sub/ance2 7,d7 evid5ce & indicators ( exposure pot5tial to humans or ! environm5t f ! *emical sub/ance1 includ+ pot5tially expos$ or susceptible populations2 7,e7 ! volume ( a *emical sub/ance manufactur$ or process$2 7,f7 :e!r ! volume ( a *emical sub/ance z report$ "u a rule promulgat$ pursuant to section #h7;a7 has significantly increas$ or decreas$ dur+ ! p]iod beg9n+ on ! date ( a previ\s report or ! date on :i* a notice has be5 submitt$ "u section #e7;b7 = t *emical sub/ance2 7,g7 ! availability ( in=mation reg>d+ pot5tial haz>ds & exposures requir$ = conduct+ a safety assessm5t or safety det]m9ation1 ) limit$ availability ( relevant in=mation to be a suffici5t basis = designat+ a *emical sub/ance z a high-priority sub/ance1 subject to ! condition t limit$ availability %all n require designation z a high-priority sub/ance2 & 7,h7 ! 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[-priority sub/ance4 7b7 ,prioritization scre5+ process & decisions 7#a7 ,9 g5]al ,! prioritization scre5+ process develop$ "u subsection 7a7 %all include a requirem5t t ! ,adm9i/rator %all-- 7,a7 id5tify ! *emical sub/ances be+ consid]$ = prioritization2 7,b7 reque/ int]e/$ p]sons to supply in=mation reg>d+ ! *emical sub/ances be+ consid]$2 7,c7 apply ! crit]ia id5tifi$ 9 subsection 7a77#d72 & 7,d7 subject to p>agraph 7#e7 & us+ ! in=mation available to ! ,adm9i/rator at ! "t ( ! decision1 id5tify a *emical sub/ance z a high-priority sub/ance or a l[-priority sub/ance4 7#b7 ,integration ( in=mation ,! prioritization scre5+ decision reg>d+ a *emical sub/ance %all integrate any haz>d & exposure in=mation relat+ to ! *emical sub/ance t is available to ! ,adm9i/rator4 7#c7 ,id5tification ( high-priority sub/ances ,! ,adm9i/rator-- 7,a7 %all id5tify z a high-priority sub/ance a *emical sub/ance t1 relative to o!r *emical sub/ances1 ! ,adm9i/rator det]m9es has ! pot5tial = high haz>d & widespread exposure2 7,b7 may id5tify z a high-priority sub/ance a *emical sub/ance t1 relative to o!r *emical sub/ances1 ! ,adm9i/rator det]m9es has ! pot5tial = high haz>d or widespread exposure2 & 7,c7 may id5tify z a high-priority sub/ance an inactive sub/ance1 z det]m9$ "u subsection 7a77#c77;,a77ii7 & section #h7;b71 t ! ,adm9i/rator det]m9es w>rants a safety assessm5t & safety det]m9ation "u section #f4 7#d7 ,id5tification ( l[-priority sub/ances ,! ,adm9i/rator %all id5tify z a l[-priority sub/ance a *emical sub/ance t ! ,adm9i/rator concludes has in=mation suffici5t to e/abli% t ! *emical sub/ance is likely to meet ! applicable safety /&>d4 7#e7 ,def]r+ a decision ,if ! ,adm9i/rator det]m9es t additional in=mation is requir$ to e/abli% ! priority ( a *emical sub/ance "u ?is section1 ! ,adm9i/rator may def] ! prioritization scre5+ decision = a reasonable p]iod-- 7,a7 to all[ = ! submission ( additional in=mation by an int]e/$ p]son & = ! ,adm9i/rator to evaluate ! additional in=mation2 or 7,b7 to require ! developm5t ( in=mation pursuant to a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u section #d7;a77#b74 7#f7 ,deadl9es = submission ( in=mation ,if ! ,adm9i/rator reque/s ! developm5t or submission ( in=mation "u ?is section1 ! ,adm9i/rator %all e/abli% a deadl9e = submission ( ! in=mation4 7#g7 ,notice & comm5t ,! ,adm9i/rator %all-- 7,a7 publi% ! propos$ decisions made "u p>agraphs 7#c71 7#d71 & 7#e7 & ! basis = ! decisions2 & 7,b7 provide an opportunity = public comm5t4 7#h7 ,revisions ( prior designations 7,a7 ,9 g5]al ,at any "t1 & at ! discretion ( ! ,adm9i/rator1 ! ,adm9i/rator may revise ! designation ( a *emical sub/ance z a high-priority sub/ance or a l[-priority sub/ance bas$ on in=mation available to ! ,adm9i/rator aft] ! date ( ! det]m9ation "u p>agraph 7#c7 or 7#d74 7,b7 ,limit$ availability ,if limit$ availability ( relevant in=mation 0 a basis 9 ! designation ( a *emical sub/ance z a high-priority sub/ance1 ! ,adm9i/rator %all reevaluate ! prioritization scre5+ ( ! *emical sub/ance on receiv+ ! relevant in=mation4 7#i7 ,o!r in=mation relevant to prioritization 7,a7 ,9 g5]al ,if1 aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 a ,/ate proposes an adm9i/rative action or enacts a /atute or takes an adm9i/rative action to prohibit or o!rwise re/rict ! manufactur+1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance t ! ,adm9i/rator has n z designat$ a high-priority sub/ance1 ! ,gov]nor or ,/ate ag5cy ) responsibility = implem5t+ ! /atute or adm9i/rative action %all notify ! ,adm9i/rator4 7,b7 ,reque/s = in=mation ,foll[+ receipt ( a notification provid$ "u subp>agraph 7,a71 ! ,adm9i/rator may reque/ any available in=mation f ! ,gov]nor or ! ,/ate ag5cy ) respect to-- 7i7 sci5tific evid5ce relat$ to ! haz>ds1 exposures & risks ( ! *emical sub/ance "u ! conditions ( use :i* ! /atute or adm9i/rative action is int5d$ to address2 7ii7 any ,/ate or local conditions :i* w>rant$ ! /atute or adm9i/rative action2 7iii7 ! /atutory or adm9i/rative au?ority on :i* ! action is bas$2 & 7iv7 any o!r available in=mation relevant to ! prohibition or o!r re/riction1 includ+ in=mation on any alt]natives consid]$ & _! haz>ds1 exposures1 & risks4 7,c7 ,prioritization scre5+ ,! ,adm9i/rator %all conduct a prioritization scre5+ "u ?is subsection = all sub/ances t-- 7i7 are ! subject ( notifications receiv$ "u subp>agraph 7,a72 & 7ii7 ! ,adm9i/rator det]m9es-- 7,i7 are likely to h significant heal? or environm5tal impacts2 7,,ii7 are likely to h significant impact on int]/ate comm]ce2 or 7,,iii7 h be5 subject to a prohibition or o!r re/riction "u a /atute or adm9i/rative action 9 #b or m ,/ates4 7,d7 ,availability to public ,subject to section #ad & any applicable ,/ate law reg>d+ ! protection ( confid5tial in=mation provid$ to ! ,/ate or to ! ,adm9i/rator1 ! ,adm9i/rator %all make in=mation receiv$ f a ,gov]nor or ,/ate ag5cy "u subp>agraph 7,a7 publicly available4 7,e7 ,effect ( p>agraph ,no?+ 9 ?is p>agraph %all preempt a ,/ate /atute or adm9i/rative action1 require approval ( a ,/ate /atute or adm9i/rative action1 or apply section #ae to a ,/ate4 7#aj7 ,review ,n less frequ5tly ?an once e #e ye>s aft] ! date on :i* ! process "u ?is subsection is e/abli%$1 ! ,adm9i/rator %all-- 7,a7 review ! process on ! basis ( exp]i5ce & tak+ into consid]ation res\rces available to effici5tly & effectively scre5 & prioritize *emical sub/ances2 & 7,b7 if necess>y1 modify ! prioritization scre5+ process4 7#aa7 ,effect ,subject to section #ah1 a designation by ! ,adm9i/rator "u ?is section ) respect to a *emical sub/ance %all n affect-- 7,a7 ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( ! *emical sub/ance2 or 7,b7 ! regulation ( ^? activities4 7c7 ,additional priorities = safety assessm5ts & det]m9ations 7#a7 ,9 g5]al ,! prioritization scre5+ process develop$ "u subsection 7a7 %all-- 7,a7 include a process by :i* a manufactur] or processor ( an active *emical sub/ance t has n be5 designat$ a high-priority sub/ance1 or t has n be5 subject to or is n 9 ! process ( a prioritization scre5+ by ! ,adm9i/rator1 may reque/ t ! ,adm9i/rator designate ! sub/ance = a safety assessm5t & safety det]m9ation1 subject to ! paym5t ( fees pursuant to section #bf7;b77#c77;,e72 & 7,b7 provide guidance to submitt]s on ! in=mation to be provid$ 9 su* reque/s1 & specify ! crit]ia ! ,adm9i/rator %all use to det]m9e :e!r or n to grant su* a reque/1 :i* %all include :e!r ! sub/ance is subject to re/rictions impos$ by /atutes enact$ or adm9i/rative actions tak5 by #a or m ,/ates on ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( ! sub/ance4 7#b7 ,pref]5ce ,subject to p>agraph 7#c71 9 decid+ :e!r to grant reque/s "u ?is subsection ! ,adm9i/rator %all give a pref]5ce to reque/s conc]n+ sub/ances = :i* ! ,adm9i/rator det]m9es t re/rictions impos$ by #a or m ,/ates h ! pot5tial to h a significant impact on int]/ate comm]ce or heal? or ! environm5t4 7#c7 ,limitations ,9 consid]+ :e!r to grant a reque/ submitt$ "u p>agraph 7#a71 ! ,adm9i/rator %all ensure t-- 7,a7 n m ?an #ae p]c5t ( ! total numb] ( sub/ances designat$ to und]go safety assessm5ts & safety det]m9ations "u ?is section are sub/ances designat$ "u ! process & crit]ia pursuant to p>agraph 7#a72 & 7,b7 ! res\rces allocat$ to conduct+ safety assessm5ts & safety det]m9ations = additional priorities designat$ "u ?is subsection are proportionate to ! numb] ( su* sub/ances relative to ! total numb] ( sub/ances designat$ to und]go safety assessm5ts & safety det]m9ations "u ?is section4 7#d7 ,requirem5ts 7,a7 ,9 g5]al ,! public %all be provid$ notice & an opportunity to comm5t on reque/s submitt$ "u ?is subsection4 7,b7 ,decision by ,adm9i/rator ,n lat] ?an #ahj days aft] ! date on :i* ! ,adm9i/rator receives a reque/ "u ?is subsection1 ! ,adm9i/rator %all decide :e!r or n to grant ! reque/4 7,c7 ,assessm5t & det]m9ation ,if ! ,adm9i/rator grants a reque/ "u ?is subsection1 ! safety assessm5t & safety det]m9ation-- 7i7 %all be conduct$ 9 accordance ) ! deadl9es & o!r requirem5ts ( sections #c;,a7i7 & #f2 & 7ii7 %all n be exp$it$ or o!rwise subject to special treatm5t relative to high-priority sub/ances designat$ pursuant to subsection 7b77#c7 t are und]go+ safety assessm5ts & safety det]m9ations4 7#e7 ,exceptions ,reque/s grant$ "u ?is subsection %all n be subject to subsection 7a77#c77;,a77iii7 or section #ah7;b74 4 #g4 ,new *emicals & significant new uses ,section #e ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjd7 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & ins]t+ ! foll[+3 #e4 ,new *emicals & significant new uses 2 7#b7 by /rik+ subsection 7b72 7#c7 by r$esignat+ subsection 7a7 z subsection 7b72 7#d7 by r$esignat+ subsection 7i7 z subsection 7a7 & mov+ ! subsection s z to appe> at ! beg9n+ ( ! section2 7#e7 9 subsection 7b7 7z s r$esignat$7-- 7,a7 9 ! subsection head+1 by /rik+ ,9 g5]al & ins]t+ ,notices2 & 7,b7 9 p>agraph 7#a71 9 ! matt] foll[+ subp>agraph 7,b7-- 7i7 by /rik+ subsection 7d7 & ins]t+ subsection 7b72 & 7ii7 by /rik+ & su* p]son complies ) any applicable requirem5t ( subsection 7b72 7#f7 by r$esignat+ subsections 7c7 & 7d7 z subsection 7d7 & 7c71 respectively1 & mov+ subsection 7c7 7z s r$esign$7 s z appe> aft] subsection 7b7 7z r$esignat$ by p>agraph 7#c772 7#g7 9 subsection 7c7 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$]al ,regulations 7or successor regulations72 & 7,b7 in=mation reg>d+ conditions ( use & reasonably anticipat$ exposures4 2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ or ( data "u subsection 7b72 7ii7 9 subp>agraph 7,a71 by add+ & aft] ! semicolon at ! end2 7iii7 9 subp>agraph 7,b71 by /rik+ 2 & & ins]t+ a p]iod2 & 7iv7 by /rik+ subp>agraph 7,c72 & 7,c7 9 p>agraph 7#c71 by /rik+ subsection 7a7 & = :i* ! notification p]iod prescrib$ by subsection 7a71 7b71 or 7c7 & ins]t+ subsection 7b7 & = :i* ! notification p]iod prescrib$ by subsection 7b7 or 7d72 7#h7 by /rik+ subsection 7d7 7z r$esignat$ by p>agraph 7#f77 & ins]t+ ! foll[+3 7d7 ,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 7b71 ! ,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#c74 7,b7 ,ext5sion ,except z provid$ 9 p>agraph 7#e71 ! ,adm9i/rator may ext5d ! p]iod describ$ 9 subp>agraph 7,a7 = good cause = #a or m p]iods1 ! total ( :i* %all be n m ?an #ij days4 7#b7 ,in=mation s\rces ,9 evaluat+ a notice "u p>agraph 7#a71 ! ,adm9i/rator %all take into consid]ation-- 7,a7 any relevant in=mation id5tifi$ 9 subsection 7c77#a72 & 7,b7 any o!r relevant additional in=mation available to ! ,adm9i/rator4 7#c7 ,det]m9ations ,be=e ! end ( ! applicable p]iod = review "u p>agraph 7#a71 bas$ on ! in=mation describ$ 9 p>agraph 7#b71 & subject to section #ah7;g71 ! ,adm9i/rator %all det]m9e t-- 7,a7 ! relevant *emical sub/ance or significant new use is n likely to meet ! safety /&>d1 9 :i* case ! ,adm9i/rator %all take appropriate action "u p>agraph 7#d72 7,b7 ! relevant *emical sub/ance or significant new use is likely to meet ! safety /&>d1 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#e74 7#d7 ,re/rictions 7,a7 ,det]m9ation by ,adm9i/rator 7i7 ,9 g5]al ,if ! ,adm9i/rator makes a det]m9ation "u subp>agraph 7,a7 or 7,c7 ( p>agraph 7#c7 ) respect to a notice submitt$ "u subsection 7b7-- 7,i7 ! ,adm9i/rator1 be=e ! end ( ! applicable p]iod = review "u p>agraph 7#a7 & by cons5t agreem5t or ord]1 z appropriate1 %all prohibit or o!rwise re/rict ! manufacture1 process+1 use1 di/ribution 9 comm]ce1 or disposal 7z applicable7 ( ! *emical sub/ance1 or ( ! *emical sub/ance = a significant new use1 )\t compliance ) ! re/rictions specifi$ 9 ! cons5t agreem5t or ord] t ! ,adm9i/rator det]m9es are suffici5t to ensure t ! *emical sub/ance or significant new use is likely to meet ! safety /&>d2 & 7,,ii7 no p]son may comm5ce manufacture ( ! *emical sub/ance1 or manufacture or process+ ( ! *emical sub/ance = a significant new use1 except 9 compliance ) ! re/rictions specifi$ 9 ! cons5t agreem5t or ord]4 7ii7 ,likely to meet /&>d ,if ! ,adm9i/rator makes a det]m9ation "u subp>agraph 7,b7 ( p>agraph 7#c7 ) respect to a *emical sub/ance or significant new use = :i* a notice 0 submitt$ "u subsection 7b71 at ! end ( ! applicable p]iod = review "u p>agraph 7#a71 ! submitt] ( ! notice may comm5ce manufacture = comm]cial purposes ( ! *emical sub/ance or manufacture or process+ ( ! *emical sub/ance = a significant new use4 7,b7 ,requirem5ts ,n lat] ?an #ij days aft] issu+ a cons5t agreem5t or ord] "u subp>agraph 7,a71 ! ,adm9i/rator %all-- 7i7 take into consid]ation :e!r to promulgate a rule pursuant to subsection 7b77#b7 t id5tifies z a significant new use any manufactur+1 process+1 use1 di/ribution 9 comm]ce1 or disposal ( ! *emical sub/ance1 or ( ! *emical sub/ance = a new use1 t is n 9 compliance ) ! re/rictions impos$ by ! cons5t agreem5t or ord]2 & 7ii7 7,i7 initiate a rulemak+ describ$ 9 clause 7i72 or 7,,ii7 publi% a /atem5t describ+ ! reasons ( ! ,adm9i/rator = n initiat+ a rulemak+4 7,c7 ,inclusions ,a prohibition or o!r re/riction "u subp>agraph 7,a7 may include1 z appropriate-- 7i7 subject to section #ah7;g71 a requirem5t t a *emical sub/ance %all be m>k$ )1 or accompani$ by1 cle> & adequate m9imum w>n+s & in/ructions ) respect to use1 di/ribution 9 comm]ce1 or disposal1 or any comb9ation ( ^? activities1 ) ! =m & cont5t ( ! m9imum w>n+s & in/ructions to be prescrib$ by ! ,adm9i/rator2 7ii7 a requirem5t t manufactur]s or processors ( ! *emical sub/ance %all-- 7,i7 make & reta9 records ( ! processes us$ to manufacture or process1 z applicable1 ! *emical sub/ance2 or 7,,ii7 monitor or conduct su* additional te/s z are reasonably necess>y to address pot5tial risks f ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal1 z applicable1 ( ! *emical sub/ance1 subject to section #d2 7iii7 a re/riction on ! quantity ( ! *emical sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce-- 7,i7 9 g5]al2 or 7,,ii7 = a p>ticul> use2 7iv7 a prohibition or o!r re/riction (-- 7,i7 ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance = a significant new use2 7,,ii7 any me?od ( comm]cial use ( ! *emical sub/ance2 or 7,,iii7 any me?od ( disposal ( ! *emical sub/ance2 or 7v7 a prohibition or o!r re/riction on ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance-- 7,i7 9 g5]al2 or 7,,ii7 = a p>ticul> use4 7,d7 ,workplace exposures ,! ,adm9i/rator %all consult ) ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal? prior to adopt+ any prohibition or o!r re/riction "u ?is subsection to address workplace exposures4 7,e7 ,def9ition ( requirem5t ,= purposes ( ?is ,act1 ! t]m requirem5t z us$ 9 ?is section does n displace common law4 7#e7 ,additional in=mation ,if ! ,adm9i/rator det]m9es "u p>agraph 7#c77;,c7 t additional in=mation is necess>y to conduct a review "u ?is subsection1 ! ,adm9i/rator-- 7,a7 %all provide an opportunity = ! submitt] ( ! notice to submit ! 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 may promulgate a rule1 ent] into a te/+ cons5t agreem5t1 or issue an ord] "u section #d to require ! developm5t ( ! in=mation2 & 7,d7 on receipt ( in=mation ! ,adm9i/rator f9ds supports ! det]m9ation "u p>agraph 7#c71 %all promptly make ! det]m9ation4 2 7#i7 by /rik+ subsections 7e7 ?r\gh 7g7 & ins]t+ ! foll[+3 7e7 ,notice ( comm5cem5t 7#a7 ,9 g5]al ,n lat] ?an #cj days aft] ! date on :i* a manufactur] t has submitt$ a notice "u subsection 7b7 comm5ces nonexempt comm]cial manufacture ( a *emical sub/ance1 ! manufactur] %all submit to ! ,adm9i/rator a notice ( comm5cem5t t id5tifies-- 7,a7 ! "n ( ! manufactur]2 & 7,b7 ! initial date ( nonexempt comm]cial manufacture4 7#b7 ,)drawal ,a manufactur] or processor t has submitt$ a notice "u subsection 7b71 b t has n comm5c$ nonexempt comm]cial manufacture or process+ ( ! *emical sub/ance1 may )draw ! notice4 7f7 ,fur!r evaluation ,! ,adm9i/rator may review a *emical sub/ance "u section #d;,a at any "t aft] ! ,adm9i/rator receives-- 7#a7 a notice ( comm5cem5t = a *emical sub/ance "u subsection 7c72 or 7#b7 new in=mation reg>d+ ! *emical sub/ance4 7g7 ,transp>5cy ,subject to section #ad1 ! ,adm9i/rator %all make available to ! public-- 7#a7 all notices1 det]m9ations1 cons5t agreem5ts1 rules1 & ord]s ( ! ,adm9i/rator2 & 7#b7 all in=mation submitt$ or issu$ "u ?is section4 2 & 7#aj7 9 subsection 7h7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ 7a7 or2 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 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7b72 7,e7 9 p>agraph 7#c7 7z s r$esignat$7-- 7i7 9 ! fir/ s5t5ce1 by /rik+ w n pres5t an unreasonable risk ( injury to heal? or ! environm5t & ins]t+ w meet ! safety /&>d2 & 7ii7 by /rik+ ! second s5t5ce2 7,f7 9 p>agraph 7#d7 7z s r$esignat$71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7b72 & 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#d74 #h4 ,safety assessm5ts & safety det]m9ations ,section #f ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfje7 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & ins]t+ ! foll[+3 #f4 ,safety assessm5ts & safety det]m9ations 2 7#b7 by r$esignat+ subsections 7e7 & 7f7 z subsections 7g7 & 7h71 respectively2 7#c7 by /rik+ subsections 7a7 ?r\gh 7d7 & ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,adm9i/rator-- 7#a7 %all conduct a safety assessm5t & make a safety det]m9ation ( ea* high-priority sub/ance 9 accordance ) subsections 7b7 & 7c72 7#b7 %all1 z soon z practicable & n lat] ?an #f mon?s aft] ! date on :i* a *emical sub/ance is designat$ z a high-priority sub/ance1 def9e ! scope ( ! safety assessm5t & safety det]m9ation to be conduct$ pursuant to ?is section1 includ+ ! haz>ds1 exposures1 conditions ( use1 & pot5tially expos$ or susceptible populations t ! ,adm9i/rator expects to consid]2 7#c7 z appropriate bas$ on ! results ( a safety det]m9ation1 %all e/abli% re/rictions pursuant to subsection 7d72 7#d7 %all complete a safety assessm5t & safety det]m9ation n lat] ?an #c ye>s aft] ! date on :i* a *emical sub/ance is designat$ z a high-priority sub/ance2 7#e7 %all promulgate a f9al rule pursuant to subsection 7d7 by n lat] ?an #b ye>s aft] ! date on :i* ! safety det]m9ation is complet$2 & 7#f7 may ext5d any deadl9e "u ?is subsection = a reasonable p]iod ( "t aft] an adequate public ju/ification1 subject to ! condition t ! aggregate l5g? ( all ext5sions ( deadl9es "u p>agraphs 7#d7 & 7#e7 & any def]ral "u subsection 7c77#b7 does n exce$ #b ye>s4 7b7 ,prior actions 7#a7 ,prior-initiat$ assessm5ts 7,a7 ,9 g5]al ,no?+ 9 ?is ,act prev5ts ! ,adm9i/rator f initiat+ a safety assessm5t or safety det]m9ation reg>d+ a *emical sub/ance1 or f cont9u+ or complet+ su* a safety assessm5t or safety det]m9ation t 0 initiat$ be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 prior to ! effective date ( ! policies & proc$ures requir$ to be e/abli%$ by ! ,adm9i/rator "u section #c;,a or #d;,a4 7,b7 ,integration ( prior policies & proc$ures ,z policies & proc$ures "u section #c;,a & #d;,a are e/abli%$1 to ! maximum ext5t practicable1 ! ,adm9i/rator %all integrate ! policies & proc$ures into ongo+ safety assessm5ts & safety det]m9ations4 7#b7 ,actions complet$ prior to completion ( policies & proc$ures ,no?+ 9 ?is ,act requires ! ,adm9i/rator to revise or )draw a complet$ safety assessm5t1 safety det]m9ation1 or rule solely because ! action 0 complet$ prior to ! completion ( a policy or proc$ure e/abli%$ "u section #c;,a or #d;,a1 & ! validity ( a complet$ assessm5t1 det]m9ation1 or rule %all n be det]m9$ bas$ on ! cont5t ( su* a policy or proc$ure4 7c7 ,safety det]m9ations 7#a7 ,9 g5]al ,bas$ on a review ( ! in=mation available to ! ,adm9i/rator1 includ+ draft safety assessm5ts submitt$ by int]e/$ p]sons1 & subject to section #ah1 ! ,adm9i/rator %all det]m9e t-- 7,a7 ! relevant *emical sub/ance meets ! safety /&>d2 7,b7 ! relevant *emical sub/ance does n meet ! safety /&>d1 9 :i* case ! ,adm9i/rator %all1 by rule "u subsection 7d7-- 7i7 impose re/rictions necess>y to ensure t ! *emical sub/ance meets ! safety /&>d "u ! conditions ( use2 or 7ii7 if ! safety /&>d _c be met ) ! application ( re/rictions1 ban or phase out ! *emical sub/ance1 z appropriate2 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#b74 7#b7 ,additional in=mation ,if ! ,adm9i/rator det]m9es t additional in=mation is necess>y to make a safety assessm5t or safety det]m9ation = 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]iod consi/5t ) ! deadl9es describ$ 9 subsection 7a71 a safety assessm5t & safety det]m9ation until aft] receipt ( ! in=mation2 & 7,d7 consi/5t ) ! deadl9es describ$ 9 subsection 7a71 on receipt ( in=mation ! ,adm9i/rator f9ds supports ! safety assessm5t & safety det]m9ation1 %all make a det]m9ation "u p>agraph 7#a74 7#c7 ,e/abli%m5t ( deadl9e ,9 reque/+ ! developm5t or submission ( in=mation "u ?is section1 ! ,adm9i/rator %all e/abli% a deadl9e = ! submission ( ! in=mation4 7d7 ,rule 7#a7 ,implem5tation ,if ! ,adm9i/rator makes a det]m9ation "u subsection 7c77#a77;,b7 ) respect to a *emical sub/ance1 ! ,adm9i/rator %all promulgate a rule e/abli%+ re/rictions necess>y to ensure t ! *emical sub/ance meets ! safety /&>d4 7#b7 ,scope ,! rule promulgat$ pursuant to ?is subsection-- 7,a7 may-- 7i7 apply to mixtures conta9+ ! *emical sub/ance1 z appropriate2 & 7ii7 exempt replacem5t p>ts = articles manufactur$ prior to ! applicable compliance deadl9e2 & 7,b7 %all include dates by :i* compliance is m&atory1 :i*-- 7i7 %all be z soon z practicable2 & 7ii7 z det]m9$ by ! ,adm9i/rator1 may v>y = diff]5t affect$ p]sons4 7,c7 ,workplace exposures ,! ,adm9i/rator %all consult ) ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal? be=e adopt+ any prohibition or o!r re/riction "u ?is subsection to address workplace exposures4 7,d7 ,def9ition ( requirem5t ,= ! purposes ( ?is ,act1 ! t]m requirem5t z us$ 9 ?is section does n displace common law4 7#c7 ,re/rictions ,a re/riction "u p>agraph 7#a7 may include1 z appropriate-- 7,a7 subject to section #ah1 a requirem5t t a *emical sub/ance %all be m>k$ )1 or accompani$ by1 cle> & adequate m9imum w>n+s & in/ructions ) respect to use1 di/ribution 9 comm]ce1 or disposal1 or any comb9ation ( ^? activities1 ) ! =m & cont5t ( ! m9imum w>n+s & in/ructions to be prescrib$ by ! ,adm9i/rator2 7,b7 a requirem5t t manufactur]s or processors ( ! *emical sub/ance %all-- 7i7 make & reta9 records ( ! processes us$ to manufacture or process ! *emical sub/ance2 7ii7 describe & apply ! relevant quality control proc$ures foll[$ 9 ! manufactur+ or process+ ( ! sub/ance2 or 7iii7 monitor or conduct te/s t are reasonably necess>y to ensure compliance ) ! requirem5ts ( any rule "u ?is subsection2 7,c7 a re/riction on ! quantity ( ! *emical sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce2 7,d7 a requirem5t to ban or phase out1 or any o!r rule reg>d+1 ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance =-- 7i7 a p>ticul> use2 7ii7 a p>ticul> use at a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator2 or 7iii7 all uses2 7,e7 a re/riction on ! quantity ( ! *emical sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce =-- 7i7 a p>ticul> use2 or 7ii7 a p>ticul> use at a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator2 7,f7 a requirem5t to ban1 phase out1 or o!rwise re/rict any me?od ( comm]cial use ( ! *emical sub/ance2 7,g7 a requirem5t to ban1 phase out1 or o!rwise re/rict any me?od ( disposal ( ! *emical sub/ance or any article conta9+ ! *emical sub/ance2 & 7,h7 a requirem5t direct+ manufactur]s or processors ( ! *emical sub/ance to give notice ( ! ,adm9i/rator's det]m9ation "u subsection 7c77#a77;,b7 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/ance4 7#d7 ,analysis = rulemak+ 7,a7 ,consid]ations ,9 decid+ :i* re/rictions to impose "u p>agraph 7#c7 z "p ( develop+ a rule "u p>agraph 7#a71 ! ,adm9i/rator %all take into consid]ation1 to ! ext5t practicable bas$ on reasonably available in=mation1 ! quantifiable & nonquantifiable co/s & b5efits ( ! propos$ regulatory action & ( ! #a or m prim>y alt]native regulatory actions consid]$ by ! ,adm9i/rator4 7,b7 ,alt]natives ,z "p ( ! analysis1 ! ,adm9i/rator %all review any #a or m te*nically & economically feasible alt]natives to ! *emical sub/ance t ! ,adm9i/rator det]m9es are relevant to ! rulemak+4 7,c7 ,public availability ,9 propos+ a rule "u p>agraph 7#a71 ! ,adm9i/rator %all make publicly available any analysis conduct$ "u ?is p>agraph4 7,d7 ,/atem5t requir$ ,9 mak+ f9al a rule "u p>agraph 7#a71 ! ,adm9i/rator %all include a /atem5t describ+ h[ ! analysis consid]$ "u subp>agraph 7,a7 0 tak5 into acc\nt4 7#e7 ,exemptions 7,a7 ,9 g5]al ,! ,adm9i/rator may exempt #a or m uses ( a *emical sub/ance f any re/riction 9 a rule promulgat$ "u p>agraph 7#a7 if ! ,adm9i/rator det]m9es t-- 7i7 ! rule _c be compli$ )1 )\t-- 7,i7 h>m+ national security2 7,,ii7 caus+ significant disruption 9 ! national economy due to ! lack ( availability ( a *emical sub/ance2 or 7,,iii7 int]f]+ ) a critical or ess5tial use = :i* no te*nically & economically feasible saf] alt]native is available1 tak+ into consid]ation haz>d & exposure2 or 7ii7 ! use ( ! *emical sub/ance1 z comp>$ to reasonably available alt]natives1 provides a sub/antial b5efit to heal?1 ! environm5t1 or public safety4 7,b7 ,exemption analysis ,9 propos+ a rule "u p>agraph 7#a7 t includes an exemption "u ?is p>agraph1 ! ,adm9i/rator %all make publicly available any analysis conduct$ "u ?is p>agraph to assess ! ne$ = ! exemption4 7,c7 ,/atem5t requir$ ,9 mak+ f9al a rule "u p>agraph 7#a7 t includes an exemption "u ?is p>agraph1 ! ,adm9i/rator %all include a /atem5t describ+ h[ ! analysis consid]$ "u subp>agraph 7,b7 0 tak5 into acc\nt4 7,d7 ,analysis 9 case ( ban or phase-out ,9 det]m9+ :e!r an exemption %\ld be grant$ "u ?is p>agraph = a *emical sub/ance = :i* a ban or phase-out is propos$1 ! ,adm9i/rator %all take into consid]ation1 to ! ext5t practicable bas$ on reasonably available in=mation1 ! quantifiable & nonquantifiable co/s & b5efits ( ! #a or m te*nically & economically feasible alt]natives to ! *emical sub/ance mo/ likely to be us$ 9 place ( ! *emical sub/ance "u ! conditions ( use if ! rule is promulgat$4 7,e7 ,conditions ,z "p ( a rule promulgat$ "u p>agraph 7#a71 ! ,adm9i/rator %all include conditions 9 any exemption e/abli%$ "u ?is p>agraph1 includ+ reasonable recordkeep+1 monitor+1 & report+ requirem5ts1 to ! ext5t t ! ,adm9i/rator det]m9es ! conditions are necess>y to protect heal? & ! environm5t :ile a*iev+ ! purposes ( ! exemption4 7,f7 ,duration 7i7 ,9 g5]al ,! ,adm9i/rator %all e/abli%1 z "p ( a rule "u p>agraph 7#a7 t conta9s an exemption "u ?is p>agraph1 a "t limit on any exemption = a "t to be det]m9$ by ! ,adm9i/rator z reasonable on a case-by-case basis4 7ii7 ,au?ority ( ,adm9i/rator ,! ,adm9i/rator1 by rule1 may ext5d1 modify1 or elim9ate ! exemption if ! ,adm9i/rator det]m9es1 on ! basis ( reasonably available in=mation & aft] adequate public ju/ification1 ! exemption w>rants ext5sion or is no long] necess>y4 7iii7 ,consid]ations 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 ! ,adm9i/rator %all issue exemptions & e/abli% "t p]iods by consid]+ factors det]m9$ by ! ,adm9i/rator to be relevant to ! goals ( fo/]+ innovation & ! developm5t ( alt]natives t meet ! safety /&>d4 7,,ii7 ,limitation ,any r5ewal ( an exemption 9 ! case ( a rule requir+ ! ban or phase-out ( a *emical sub/ance %all n exce$ #e ye>s4 7e7 ,imm$iate effect ,! ,adm9i/rator may decl>e a propos$ rule "u subsection 7d7 to be effective on publication ( ! rule 9 ! ,f$]al ,regi/] & until ! effective date ( f9al action tak5 respect+ ! rule1 if-- 7#a7 ! ,adm9i/rator det]m9es t-- 7,a7 ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( ! *emical sub/ance or mixture subject to ! propos$ rule or any comb9ation ( ^? activities is likely to result 9 an unreasonable risk ( s]i\s or widespread h>m to heal? or ! environm5t be=e ! effective date2 & 7,b7 mak+ ! propos$ rule s effective is necess>y to protect ! public int]e/2 & 7#b7 9 ! case ( a propos$ rule to prohibit ! manufacture1 process+1 or di/ribution ( a *emical sub/ance or mixture because ( ! risk det]m9$ "u p>agraph 7#a77;,a71 a c\rt has grant$ relief 9 an action "u section #g ) respect to t risk associat$ ) ! *emical sub/ance or mixture4 7f7 ,f9al ag5cy action ,"u ?is section & subject to section #ah-- 7#a7 a safety det]m9ation1 & ! associat$ safety assessm5t1 = a *emical sub/ance t ! ,adm9i/rator det]m9es "u subsection 7c7 meets ! safety /&>d1 %all be consid]$ to be a f9al ag5cy action1 effective beg9n+ on ! date ( issuance ( ! f9al safety det]m9ation2 & 7#b7 a f9al rule promulgat$ "u subsection 7d71 & ! associat$ safety assessm5t & safety det]m9ation t a *emical sub/ance does n meet ! safety /&>d1 %all be consid]$ to be a f9al ag5cy action1 effective beg9n+ on ! date ( promulgation ( ! f9al rule4 2 & 7#d7 9 subsection 7g7 7z r$esignat$ by p>agraph 7#b77-- 7,a7 by /rik+ p>agraph 7#d72 & 7,b7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#d74 #i4 ,imm95t haz>ds ,section #g ( ! ,toxic ,sub/ances ,control ,act 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 ,unit$ ,/ates di/rict c\rt =-- 7,a7 seizure ( an imm95tly haz>d\s *emical sub/ance or mixture or any article conta9+ ! *emical sub/ance or mixture2 7,b7 relief 7z au?oriz$ by subsection 7b77 aga9/ any p]son t 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+ ! *emical 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>agraph1 not)/&+-- 7,a7 ! exi/5ce (-- 7i7 a decision by ! ,adm9i/rator "u section #d;,a1 #e7;d77#c71 or #f7;c77#a72 or 7ii7 a rule1 te/+ cons5t agreem5t1 or ord] "u section #d1 #e7;d77#d71 #f7;d71 or #f7;h72 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 #aj4 ,in=mation collection & report+ ,section #h ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjg7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#c77;,a77ii77,i7-- 7i7 by /rik+ #e7;b77#d7 & ins]t+ #e2 7ii7 by ins]t+ section #d or aft] 9 effect "u2 & 7iii7 by /rik+ #e7;e71 & ins]t+ #e7;d77#d722 & 7,b7 by add+ at ! end ! foll[+3 7#d7 ,rules 7,a7 ,deadl9e 7i7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator %all promulgate rules requir+ ! ma9t5ance ( records & ! report+ ( in=mation kn[n or reasonably asc]ta9able by ! 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 7ii7 ,modification ( prior rules ,9 c>ry+ out ?is subp>agraph1 ! ,adm9i/rator may modify1 z appropriate1 rules promulgat$ be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 7,b7 ,cont5ts ,! rules promulgat$ pursuant to subp>agraph 7,a7-- 7i7 may impose diff]5t report+ & recordkeep+ requirem5ts on manufactur]s & processors2 & 7ii7 %all include ! level ( detail necess>y to be report$1 includ+ ! mann] by :i* use & exposure in=mation may be report$4 7,c7 ,adm9i/ration ,9 implem5t+ ! report+ & recordkeep+ requirem5ts "u ?is p>agraph1 ! ,adm9i/rator %all take measures-- 7i7 to limit ! pot5tial = duplication 9 report+ requirem5ts2 7ii7 to m9imize ! impact ( ! rules on small manufactur]s & processors2 & 7iii7 to apply any report+ obligations to ^? p]sons likely to h in=mation relevant to ! effective implem5tation ( ?is title4 7#e7 ,guidance ,! ,adm9i/rator %all develop guidance relat+ to ! in=mation requir$ to be report$ "u ! rules promulgat$ "u ?is subsection4 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 ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,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 ,if an 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 ! 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 ,*emical sub/ances 9 comm]ce 7,a7 ,rules 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator1 by rule1 %all require manufactur]s & processors to notify ! ,adm9i/rator1 by n lat] ?an #ahj days aft] ! date ( promulgation ( ! rule1 ( ea* *emical sub/ance on ! li/ publi%$ "u p>agraph 7#a7 t ! manufactur] or processor1 z applicable1 has manufactur$ or process$ = a nonexempt comm]cial purpose dur+ ! #aj-ye> p]iod end+ on ! day be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 7ii7 ,active sub/ances ,! ,adm9i/rator %all1 pursuant to p>agraph 7#e77;,a71 designate *emical sub/ances = :i* notices are receiv$ "u clause 7i7 to be active sub/ances on ! li/ publi%$ "u p>agraph 7#a74 7,b7 ,confid5tial *emical sub/ances ,! rule promulgat$ by ! ,adm9i/rator pursuant to subp>agraph 7,a7 %all require-- 7i7 ! ,adm9i/rator to ma9ta9 ! li/ "u p>agraph 7#a71 :i* %all include a confid5tial portion & a nonconfid5tial portion consi/5t ) ?is section & section #ad2 7ii7 a manufactur] or processor t is submitt+ a notice pursuant to subp>agraph 7,a7 = a *emical sub/ance on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 to indicate 9 ! notice :e!r ! manufactur] or processor seeks to ma9ta9 any exi/+ claim = protection aga9/ disclosure ( ! specific id5tity ( ! sub/ance z confid5tial pursuant to section #ad2 & 7iii7 ! sub/antiation ( ^? claims pursuant to section #ad & 9 accordance ) ! review plan describ$ 9 subp>agraph 7,c74 7,c7 ,review plan ,n lat] ?an #a ye> aft] ! date on :i* ! ,adm9i/rator compiles ! initial li/ ( active sub/ances pursuant to subp>agraph 7,a71 ! ,adm9i/rator %all promulgate a rule t e/abli%es a plan to review all claims to protect ! specific id5tities ( *emical sub/ances on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 t are notifi$ pursuant to subp>agraph 7,a7 or id5tifi$ z active sub/ances "u subsection 7f77#a74 7,d7 ,requirem5ts ( review plan ,! review plan "u subp>agraph 7,c7 %all-- 7i7 require1 at ! "t reque/$ by ! ,adm9i/rator1 all manufactur]s or processors ass]t+ claims "u subp>agraph 7,b7 to sub/antiate ! claim unless ! manufactur] or processor has sub/antiat$ ! claim 9 a submission made to ! ,adm9i/rator dur+ ! #e-ye> p]iod end+ on ! date ( ! reque/ by ! ,adm9i/rator2 7ii7 require ! ,adm9i/rator1 9 accordance ) section #ad-- 7,i7 to review ea* sub/antiation-- 7aa7 submitt$ pursuant to clause 7i7 to det]m9e if ! claim w>rants protection f disclosure2 & 7bb7 submitt$ previ\sly by a manufactur] or processor & reli$ on 9 lieu ( ! sub/antiation requir$ pursuant to clause 7i71 if ! sub/antiation has n be5 previ\sly review$ by ! ,adm9i/rator1 to det]m9e if ! claim w>rants protection f disclosure2 7,,ii7 approve1 modify1 or d5y ea* claim2 & 7,,iii7 except z provid$ 9 ?is section & section #ad1 protect f disclosure in=mation = :i* ! ,adm9i/rator approves su* a claim = a p]iod ( #aj ye>s1 unless1 prior to ! expiration ( ! p]iod-- 7aa7 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7bb7 ! ,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 section #ad7;g77#b72 & 7iii7 enc\rage manufactur]s or processors t h previ\sly made claims to protect ! specific id5tities ( *emical sub/ances id5tifi$ z inactive pursuant to subsection 7f77#b7 to review & ei!r )draw or sub/antiate ! claims4 7,e7 ,timel9e = completion ( reviews 7i7 ,9 g5]al ,! ,adm9i/rator %all implem5t ! review plan s z to complete reviews ( all claims specifi$ 9 subp>agraph 7,c7 n lat] ?an #e ye>s aft] ! date on :i* ! ,adm9i/rator compiles ! initial li/ ( active sub/ances pursuant to subp>agraph 7,a74 7ii7 ,consid]ations 7,i7 ,9 g5]al ,! ,adm9i/rator may ext5d ! deadl9e = completion ( ! reviews = n m ?an #b additional ye>s1 aft] an adequate public ju/ification1 if ! ,adm9i/rator det]m9es t ! ext5sion is necess>y bas$ on ! numb] ( applicable claims ne$+ review & ! available res\rces4 7,,ii7 ,annual goal ,! ,adm9i/rator %all publi% an annual goal = ! numb] ( reviews to be complet$ ov] ! c\rse ( implem5tation ( ! plan4 7#e7 ,active & inactive sub/ances 7,a7 ,9 g5]al ,! ,adm9i/rator %all ma9ta9 & keep curr5t designations ( active sub/ances & inactive sub/ances on ! li/ publi%$ "u p>agraph 7#a74 7,b7 ,update ,! ,adm9i/rator %all update ! li/ ( *emical sub/ances designat$ z active sub/ances z soon z practicable aft] ! date ( publication ( ! mo/ rec5t data report$ "u-- 7i7 "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations72 & 7ii7 ! rules promulgat$ pursuant to subsection 7a77#d74 7,c7 ,*ange to active /atus 7i7 ,9 g5]al ,any p]son t 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* ! inactive sub/ance is manufactur$ or process$4 7ii7 ,confid5tial *emical id5tity claims ,if a p]son submitt+ a notice "u clause 7i7 = an inactive sub/ance on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 seeks to ma9ta9 an exi/+ claim = protection aga9/ disclosure ( ! specific id5tity ( ! inactive sub/ance z confid5tial1 ! p]son %all-- 7,i7 9 ! notice submitt$ "u clause 7i71 ass]t ! claim2 & 7,,ii7 by n lat] ?an #cj days aft] provid+ ! notice "u clause 7i71 sub/antiate ! claim4 7iii7 ,active /atus ,on receiv+ a notification "u clause 7i71 ! ,adm9i/rator %all-- 7,i7 designate ! applicable *emical sub/ance z an active sub/ance2 7,,ii7 pursuant to section #ad1 promptly review any claim & associat$ sub/antiation submitt$ pursuant to clause 7ii7 = protection aga9/ disclosure ( ! specific id5tity ( ! *emical sub/ance & approve1 modify1 or d5y ! claim2 7,,iii7 except z provid$ 9 ?is section & section #ad1 protect f disclosure ! specific id5tity ( ! *emical sub/ance = :i* ! ,adm9i/rator approves a claim "u subclause 7,,ii7 = a p]iod ( n less ?an #aj ye>s1 unless1 prior to ! expiration ( ! p]iod-- 7aa7 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7bb7 ! ,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 section #ad7;g77#b72 & 7,,iv7 pursuant to section #d;,a1 review ! priority ( ! *emical sub/ance z ! ,adm9i/rator det]m9es to be necess>y4 7,d7 ,category /atus ,! li/ ( inactive sub/ances %all n be consid]$ to be a category = purposes ( section #bf7;c74 7#f7 ,int]im li/ ( active sub/ances ,prior to ! promulgation ( ! rule requir$ "u ?is subsection1 ! ,adm9i/rator %all designate ! *emical sub/ances report$ "u "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations71 dur+ ! report+ p]iod t mo/ closely prec$$ ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 z ! int]im li/ ( active sub/ances = ! purposes ( section #d;,a4 7#g7 ,public p>ticipation ,subject to ?is subsection1 ! ,adm9i/rator %all make available to ! public-- 7,a7 ! specific id5tity ( ea* *emical sub/ance on ! nonconfid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 t ! ,adm9i/rator has designat$ z-- 7i7 an active sub/ance2 or 7ii7 an inactive sub/ance2 7,b7 ! 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$ & approv$ by ! ,adm9i/rator pursuant to section #ad2 & 7,c7 subject to section #ad7;g71 ! specific id5tity ( any active sub/ance = :i*-- 7i7 no claim ( protection aga9/ disclosure ( ! specific id5tity ( ! active sub/ance pursuant to ?is subsection 0 receiv$2 7ii7 a claim = protection aga9/ disclosure ( ! specific id5tity ( ! active sub/ance has be5 d5i$ by ! ,adm9i/rator2 or 7iii7 ! "t p]iod = protection aga9/ disclosure ( ! specific id5tity ( ! active sub/ance has expir$4 7#h7 ,limitation ,no p]son may ass]t a new claim "u ?is subsection = protection f disclosure ( a specific id5tity ( any active or inactive *emical sub/ance = :i* a notice is receiv$ "u p>agraph 7#d77;,a77i7 or 7#e77;,c77i7 t is n on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a74 7#i7 ,c]tification ,"u ! rule promulgat$ "u ?is subsection1 manufactur]s & processors %all be requir$-- 7,a7 to c]tify t ea* report ! manufactur] or processor submits complies ) ! requirem5ts ( ! rule1 & t any confid5tiality claims are true & correct2 & 7,b7 to reta9 a record support+ ! c]tification = a p]iod ( #e ye>s beg9n+ on ! la/ day ( ! submission p]iod4 2 7#c7 9 subsection 7e7-- 7,a7 by /rik+ ,any p]son & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,any p]son 2 & 7,b7 by add+ at ! end ! foll[+3 7#b7 ,applicability ,any p]son may submit to ! ,adm9i/rator in=mation reasonably support+ ! conclusion t a *emical sub/ance or mixture pres5ts1 w pres5t1 or does n pres5t a sub/antial risk ( h>m to heal? & ! environm5t4 2 & 7#d7 9 subsection 7f71 by /rik+ ,= purposes ( ?is section1 ! & ins]t+ ! foll[+3 ,9 ?is section3 7#a7 ,active sub/ance ,! t]m active sub/ance means a *emical sub/ance-- 7,a7 t has be5 manufactur$ or process$ = a nonexempt comm]cial purpose at any po9t dur+ ! #aj-ye> p]iod end+ on ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act2 7,b7 t is add$ to ! li/ publi%$ "u subsection 7b77#a7 aft] t date ( enactm5t2 or 7,c7 = :i* a notice is receiv$ "u subsection 7b77#e77;,c74 7#b7 ,inactive sub/ance ,! t]m inactive sub/ance means a *emical sub/ance on ! li/ publi%$ "u subsection 7b77#a7 t does n meet any ( ! crit]ia describ$ 9 p>agraph 7#a74 7#c7 ,manufacture2 process ,! 4 #aa4 ,relation%ip to o!r ,f$]al laws ,section #i ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjh7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 9 ! fir/ s5t5ce-- 7i7 by /rik+ pres5ts or w pres5t an unreasonable risk to heal? or ! environm5t & ins]t+ does n meet ! safety /&>d2 & 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+ section #f7;d7 or section #g2 & 7,c7 9 p>agraph 7#c71 by /rik+ section #f or #g & ins]t+ section #f7;d7 or #g2 7#b7 9 subsection 7d71 9 ! fir/ s5t5ce1 by /rik+ ,heal?1 ,education1 & ,welf>e & ins]t+ ,heal? & ,human ,s]vices2 & 7#c7 by add+ at ! end ! foll[+3 7e7 ,exposure in=mation ,if ! ,adm9i/rator obta9s in=mation relat$ to exposures or releases ( a *emical sub/ance t may be prev5t$ or r$uc$ "u ano!r ,f$]al law1 includ+ laws n adm9i/]$ by ! ,adm9i/rator1 ! ,adm9i/rator %all make su* in=mation available to ! relevant ,f$]al ag5cy or (fice ( ! ,environm5tal ,protection ,ag5cy4 4 #ab4 ,rese>*1 developm5t1 collection1 dissem9ation1 & utilization ( data ,section #aj ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfji7 is am5d$ by /rik+ ,heal?1 ,education1 & ,welf>e ea* place x appe>s & ins]t+ ,heal? & ,human ,s]vices4 #ac4 ,exports ,section #ab ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfaa7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,exception ,p>agraph 7#a7 %all n apply to any *emical sub/ance t ! ,adm9i/rator det]m9es-- 7,a7 "u section #e is n likely to meet ! safety /&>d2 or 7,b7 "u section #f does n meet ! safety /&>d4 7#c7 ,waiv]s ,= a mixture or article conta9+ a *emical sub/ance describ$ 9 p>agraph 7#b71 ! ,adm9i/rator may-- 7,a7 det]m9e t p>agraph 7#a7 %all n apply to ! mixture or article2 or 7,b7 e/abli% a ?re%old conc5tration 9 a mixture or article at :i* p>agraph 7#a7 %all n apply4 7#d7 ,te/+ ,! ,adm9i/rator may require te/+ "u section #d ( any *emical sub/ance or mixture exempt$ f ?is ,act "u p>agraph 7#a7 = ! purpose ( det]m9+ :e!r ! *emical sub/ance or mixture meets ! safety /&>d )9 ! ,unit$ ,/ates4 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 & = :i* a prohibition or o!r re/riction has be5 propos$ or e/abli%$ "u t section2 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 & = :i* a prohibition or o!r re/riction has be5 propos$ or e/abli%$ "u t section2 7,c7 a *emical sub/ance = :i* ! ,unit$ ,/ates is obligat$ by treaty to provide export notification2 7,d7 a *emical sub/ance or mixture subject to a prohibition or o!r re/riction pursuant to a rule1 ord]1 or cons5t agreem5t 9 effect "u ?is ,act2 or 7,e7 a *emical sub/ance or mixture = :i* ! submission ( in=mation is requir$ "u section #d4 7#b7 ,rules 7,a7 ,9 g5]al ,! ,adm9i/rator %all promulgate rules to c>ry out p>agraph 7#a74 7,b7 ,cont5ts ,! rules promulgat$ pursuant to subp>agraph 7,a7 %all-- 7i7 include su* exemptions z ! ,adm9i/rator det]m9es to be appropriate1 :i* may include exemptions id5tifi$ "u section #e7;h72 & 7ii7 indicate :e!r1 or to :at ext5t1 ! rules 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,a71 7,b71 or 7,d7 ( p>agraph 7#a71 a notice ( ! det]m9ation1 rule1 ord]1 cons5t agreem5t1 requirem5t1 or designation2 7,b7 = a *emical sub/ance describ$ 9 p>agraph 7#a77;,c71 a notice t satisfies ! obligation ( ! ,unit$ ,/ates "u ! applicable treaty2 & 7,c7 = a *emical sub/ance or mixture describ$ 9 p>agraph 7#a77;,e71 a notice ( availability ( ! in=mation on ! *emical sub/ance or mixture submitt$ to ! ,adm9i/rator4 2 & 7#c7 9 subsection 7c7-- 7,a7 by /rik+ p>agraph 7#c72 & 7,b7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#e71 respectively4 #ad4 ,imports ,section #ac ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfab7 is am5d$ to read z foll[s3 #ac4 ,imports 7a7 ,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/ance1 mixture1 or article conta9+ a *emical sub/ance or mixture (f]$ = su* entry1 if-- 7,a7 ! ,adm9i/rator-- 7i7 has det]m9$ "u section #f7;c7 t ! *emical sub/ance or mixture does n meet ! safety /&>d2 & 7ii7 has promulgat$ a rule pursuant to section #f7;d7 bann+ ! *emical sub/ance or mixture1 z ( ! effective date ( ! rule2 7,b7 ! *emical sub/ance-- 7i7 is n includ$ on ! li/ "u section #h7;b77#a72 & 7ii7 is n exempt f any requirem5t to be includ$ on t li/ by ?is title or a rule promulgat$ by ! ,adm9i/rator pursuant to ?is title2 or 7,c7 ! *emical sub/ance1 mixture1 or any article conta9+ ! *emical sub/ance or mixture is (f]$ = entry 9 violation (-- 7i7 a rule1 cons5t agreem5t1 or ord] 9 effect "u ?is ,act2 or 7ii7 an ord] issu$ 9 a civil action br\ght "u section #g or title ,,iv4 7#b7 ,proc$ure 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 if a *emical sub/ance1 mixture1 or article conta9+ a *emical sub/ance or mixture is refus$ 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 dur+ ! #ij-;day p]iod beg9n+ on ! date ( receipt ( ! notice ( ! refus$ entry4 7,b7 ,exception 7i7 ,9 g5]al ,! ,secret>y ( ,homel& ,security1 p5d+ a review by ! ,adm9i/rator1 may 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 on dem&1 ! consignee %all be liable to ! ,unit$ ,/ates = liquidat$ damages equal to ! full am\nt ( ! bond execut$ "u clause 7i77,i74 7,c7 ,/orage ,all *>ges = /orage1 c>tage1 & labor on or = ! 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 7b7 ,c]tification 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 c]tify to ! ,secret>y ( ,homel& ,security t-- 7,a7 aft] reasonable inquiry & to ! be/ k & belief ( ! p]son1 ! *emical sub/ance or mixture is 9 compliance ) any applicable rule1 cons5t agreem5t1 or ord] "u section #e or #f2 & 7,b7 ! *emical sub/ance-- 7i7 is includ$ on ! li/ "u section #h7;b77#a72 or 7ii7 is exempt f any requirem5t to be includ$ on t li/ by ?is title or a rule promulgat$ by ! ,adm9i/rator pursuant to ?is title4 7#b7 ,articles 7,a7 ,9 g5]al ,! ,adm9i/rator1 by rule1 may require c]tification "u p>agraph 7#a7 = an article conta9+ a *emical sub/ance or mixture t is subject to rule "u section #e or #f4 7,b7 ,requirem5t ,! rule "u subp>agraph 7,a7 %all id5tify1 ) reasonable specificity1 ! types ( articles1 includ+ p>ts or compon5ts ( articles1 t w be subject to ! c]tification requirem5t4 7,c7 ,factors = consid]ation ,9 det]m9+ ! ne$ = & cont5t ( a c]tification rule "u ?is p>agraph1 ! ,adm9i/rator %all take into consid]ation-- 7i7 ! utility ( ! c]tification to en=cem5t ( ! applicable rule1 cons5t agreem5t1 or ord] "u section #e or #f2 7ii7 ! contribution ( import$ articles to ! pot5tial risk pres5t$ by exposure to ! *emical sub/ance or mixture subject to rule "u section #e or #f2 7iii7 ! impact on comm]ce & pot5tial = ! c]tification to imp$e or disrupt import ( articles2 7iv7 ! frequ5cy or duration ( ! c]tification requirem5t2 & 7v7 specification ( ! conc5tration ( a *emical sub/ance 9 an article t w\ld subject ! article to ! c]tification requirem5t4 7#c7 ,reasonable inquiry 7,a7 ,9 g5]al ,= purposes ( a c]tification "u p>agraph 7#a71 reasonable inquiry %all include good fai? reliance by an import] on-- 7i7 a safety data %eet or simil> decl>ation provid$ by a suppli] t docum5ts ! specific id5tity ( ! *emical sub/ance or ! specific id5tities ( all *emical sub/ances 9 a mixture2 or 7ii7 = *emical sub/ances or mixtures claim$ by ! suppli] z confid5tial1 or n o!rwise disclos$ by ! suppli]1 a c]tification by ! suppli] t ! import$ *emical sub/ance or mixture satisfies ! applicable c]tification requirem5ts "u p>agraph 7#a74 7,b7 ,articles ,= purposes ( a c]tification "u p>agraph 7#b71 reasonable inquiry %all include good fai? reliance by an import] on a c]tification by ! suppli] t ! import$ article satisfies ! applicable c]tification requirem5ts 9 a rule promulgat$ pursuant to p>agraph 7#b74 7#d7 ,in=mation reg>d+ id5tity ,= purposes ( ?is subsection1 ! ,adm9i/rator %all provide publicly accessible in=mation reg>d+ ! id5tity ( a *emical sub/ance or mixture subject to rule "u ?is ,act t w\ld be readily und]/ood 9 import transactions4 7c7 ,notice ,a p]son (f]+ a *emical sub/ance = entry into ! cu/oms t]ritory ( ! ,unit$ ,/ates %all notify ! ,secret>y ( ,homel& ,security if-- 7#a7 ! *emical sub/ance or *emical sub/ance 9 a mixture is a high-priority sub/ance2 7#b7 ! *emical sub/ance or *emical sub/ance 9 a mixture is #a = :i* ! ,unit$ ,/ates is obligat$ to provide export notification by treaty2 or 7#c7 ! *emical sub/ance or *emical sub/ance 9 a mixture-- 7,a7 is ! subject ( a safety assessm5t & safety det]m9ation conduct$ pursuant to section #f2 & 7,b7 has be5 f\nd n to meet ! safety /&>d4 7d7 ,rules 7#a7 ,9 g5]al ,! ,secret>y ( ,homel& ,security1 aft] consultation ) ! ,adm9i/rator1 %all promulgate rules to c>ry out ?is section4 7#b7 ,application ,! rules "u p>agraph 7#a7 may modify ! application ( any requirem5t ( ?is section1 z appropriate = ! effici5t & effective implem5tation ( ?is ,act4 4 #ae4 ,confid5tial in=mation ,section #ad ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfac7 is am5d$ to read z foll[s3 #ad4 ,confid5tial in=mation 7a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 ! ,adm9i/rator %all n disclose in=mation t is exempt f disclosure pursuant to subsection 7a7 ( section #eeb ( title #e1 ,unit$ ,/ates ,code1 "u subsection 7b77#d7 ( t section-- 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 ,! foll[+ in=mation specific to1 & submitt$ by1 a manufactur]1 processor1 or di/ributor t meets ! requirem5ts ( subsections 7a7 & 7d7 %all be presum$ to be protect$ f disclosure1 subject to ! condition t no?+ 9 ?is ,act prohibits ! disclosure ( any su* in=mation ?r\gh discov]y1 subpo5a1 o!r c\rt ord]1 or any o!r judicial process o!rwise all[$ "u applicable ,f$]al or ,/ate law3 7#a7 ,specific in=mation describ+ ! processes us$ 9 manufacture or process+ ( a *emical sub/ance1 mixture1 or article4 7#b7 ,m>ket+ & sales in=mation4 7#c7 ,in=mation id5tify+ a suppli] or cu/om]4 7#d7 ,details ( ! full composition ( a mixture & ! respective p]c5tages ( con/itu5ts4 7#e7 ,specific in=mation reg>d+ ! use1 function1 or application ( a *emical sub/ance or mixture 9 a process1 mixture1 or product4 7#f7 ,specific production or import volumes ( ! manufactur] & specific aggregat$ volumes across manufactur]s1 if ! ,adm9i/rator det]m9es t disclosure ( ! specific aggregat$ volumes w\ld reveal confid5tial in=mation4 7#g7 ,except z o!rwise provid$ 9 ?is section1 ! specific id5tity ( a *emical sub/ance prior to ! date on :i* ! *emical sub/ance is fir/ (f]$ = comm]cial di/ribution1 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-- 7,a7 ! specific id5tity 0 claim$ z confid5tial in=mation at ! "t x 0 submitt$ 9 a notice "u section #e2 & 7,b7 ! claim-- 7i7 is n subject to an exception "u subsection 7e72 or 7ii7 has n subsequ5tly be5 )drawn or f\nd by ! ,adm9i/rator n to w>rant protection z confid5tial in=mation "u subsection 7f77#b7 or 7g74 7c7 ,in=mation n protect$ f disclosure ,not)/&+ subsections 7a7 & 7b71 ! foll[+ in=mation %all n be protect$ f disclosure3 7#a7 ,in=mation f heal? & safety /udies 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 subsection 7a7 does n prohibit ! disclosure (-- 7i7 any heal? & safety /udy t is submitt$ "u ?is ,act ) respect to-- 7,i7 any *emical sub/ance or mixture t1 on ! date on :i* ! /udy is to be disclos$1 has be5 (f]$ = comm]cial di/ribution2 or 7,,ii7 any *emical sub/ance or mixture = :i*-- 7aa7 te/+ is requir$ "u section #d2 or 7bb7 a notification is requir$ "u section #e2 or 7ii7 any in=mation report$ to1 or o!rwise obta9$ by1 ! ,adm9i/rator f a heal? & safety /udy relat+ to a *emical sub/ance or mixture describ$ 9 subclause 7,i7 or 7,,ii7 ( clause 7i74 7,b7 ,effect ( p>agraph ,no?+ 9 ?is p>agraph au?orizes ! release ( any in=mation t discloses-- 7i7 a process us$ 9 ! manufactur+ or process+ ( a *emical sub/ance or mixture2 or 7ii7 9 ! case ( a mixture1 ! portion ( ! mixture compris$ by any *emical sub/ance 9 ! mixture4 7#b7 ,c]ta9 reque/s ,if a reque/ is made to ! ,adm9i/rator "u section #eeb7;a7 ( title #e1 ,unit$ ,/ates ,code1 = in=mation t is describ$ 9 p>agraph 7#a7 t is n describ$ 9 p>agraph 7#a77;,b71 ! ,adm9i/rator may n d5y ! reque/ on ! basis ( section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7#c7 ,o!r in=mation n protect$ f disclosure ,! foll[+ in=mation is n protect$ f disclosure "u ?is section3 7,a7 ,= in=mation submitt$ aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! specific id5tity ( a *emical sub/ance z ( ! date on :i* ! *emical sub/ance is fir/ (f]$ = comm]cial di/ribution1 if ! p]son submitt+ ! in=mation does n meet ! requirem5ts ( subsection 7d74 7,b7 ,a safety assessm5t develop$1 or a safety det]m9ation made1 "u section #f4 7,c7 ,any g5]al in=mation describ+ ! manufactur+ volumes1 express$ z specific aggregat$ volumes or1 if ! ,adm9i/rator det]m9es t disclosure ( specific aggregat$ volumes w\ld reveal confid5tial in=mation1 express$ 9 ranges4 7,d7 ,a g5]al description ( a process us$ 9 ! manufacture or process+ & indu/rial1 comm]cial1 or consum] functions & uses ( a *emical sub/ance1 mixture1 or article conta9+ a *emical sub/ance or mixture1 includ+ in=mation specific to an indu/ry or indu/ry sector t cu/om>ily w\ld be %>$ ) ! g5]al public or )9 an indu/ry or indu/ry sector4 7#d7 ,mix$ confid5tial & nonconfid5tial in=mation ,any in=mation t is o!rwise eligible = protection "u ?is section & conta9$ 9 a submission ( in=mation describ$ 9 ?is subsection %all be protect$ f disclosure1 if ! submitt] complies ) subsection 7d71 subject to ! condition t in=mation 9 ! submission t is n eligible = protection aga9/ disclosure %all be disclos$4 7#e7 ,ban or phase-out ,if ! ,adm9i/rator promulgates a rule pursuant to section #f7;d7 t e/abli%es a ban or phase-out ( ! manufacture1 process+1 or di/ribution 9 comm]ce ( a *emical sub/ance-- 7,a7 any protection f disclosure provid$ "u ?is section ) respect to in=mation relat+ to ! *emical sub/ance %all no long] apply2 & 7,b7 ! ,adm9i/rator promptly %all make ! in=mation public4 7d7 ,requirem5ts = confid5tiality claims 7#a7 ,ass]tion ( claims 7,a7 ,9 g5]al ,a p]son seek+ to protect any in=mation submitt$ "u ?is ,act f disclosure 7includ+ in=mation describ$ 9 subsection 7b77 %all ass]t to ! ,adm9i/rator a claim = protection concurr5t ) submission ( ! in=mation1 9 accordance ) su* rules reg>d+ a claim = protection f disclosure z ! ,adm9i/rator has promulgat$ or may promulgate pursuant to ?is title4 7,b7 ,inclusion ,an ass]tion ( a claim "u subp>agraph 7,a7 %all include a /atem5t t ! p]son has-- 7i7 tak5 reasonable measures to protect ! confid5tiality ( ! in=mation2 7ii7 det]m9$ t ! in=mation is n requir$ to be disclos$ or o!rwise made available to ! public "u any o!r ,f$]al law2 7iii7 a reasonable basis to conclude t disclosure ( ! in=mation is likely to cause sub/antial h>m to ! competitive position ( ! p]son2 & 7iv7 a reasonable basis to believe t ! in=mation is n readily discov]able ?r\gh rev]se eng9e]+4 7,c7 ,specific *emical id5tity ,9 ! case ( a claim "u subp>agraph 7,a7 = protection aga9/ disclosure ( a specific *emical id5tity1 ! claim %all include a /ructurally descriptive g5]ic "n = ! *emical sub/ance t ! ,adm9i/rator may disclose to ! public1 subject to ! condition t ! g5]ic "n %all-- 7i7 con=m ) guidance prescrib$ by ! ,adm9i/rator "u p>agraph 7#c77;,a72 & 7ii7 describe ! *emical /ructure ( ! sub/ance z specifically z practicable :ile protect+ ^? features ( ! *emical /ructure-- 7,i7 t are consid]$ to be confid5tial2 & 7,,ii7 ! disclosure ( :i* w\ld be likely to h>m ! competitive position ( ! p]son4 7,d7 ,public in=mation ,no p]son may ass]t a claim "u ?is section = protection f disclosure ( in=mation t is already publicly available4 7#b7 ,additional requirem5ts = confid5tiality claims ,except = in=mation describ$ 9 p>agraphs 7#a7 ?r\gh 7#g7 ( subsection 7b71 a p]son ass]t+ a claim to protect in=mation f disclosure "u ?is ,act %all sub/antiate ! claim1 9 accordance ) ! rules promulgat$ & guidance issu$ by ! ,adm9i/rator4 7#c7 ,guidance ,! ,adm9i/rator %all develop guidance reg>d+-- 7,a7 ! det]m9ation ( /ructurally descriptive g5]ic names1 9 ! case ( claims = ! protection aga9/ disclosure ( specific *emical id5tity2 & 7,b7 ! cont5t & =m ( ! /atem5ts ( ne$ & agreem5ts requir$ "u p>agraphs 7#d71 7#e71 & 7#f7 ( subsection 7e74 7#d7 ,c]tification ,an au?oriz$ (ficial ( a p]son describ$ 9 p>agraph 7#a77;,a7 %all c]tify t ! in=mation t has be5 submitt$ is true & correct4 7e7 ,exceptions to protection f disclosure ,in=mation describ$ 9 subsection 7a7 %all be disclos$ if-- 7#a7 ! in=mation is to be disclos$ to an (fic] or employee ( ! ,unit$ ,/ates 9 connection ) ! (ficial duties ( ! (fic] or employee-- 7,a7 "u any law = ! protection ( heal? or ! environm5t2 or 7,b7 = a specific law en=cem5t purpose2 7#b7 ! in=mation is to be disclos$ to a contractor ( ! ,unit$ ,/ates & employees ( t contractor-- 7,a7 if1 9 ! op9ion ( ! ,adm9i/rator1 ! disclosure is necess>y = ! satisfactory p]=mance by ! contractor ( a contract ) ! ,unit$ ,/ates = ! p]=mance ( "w 9 connection ) ?is ,act2 & 7,b7 subject to su* conditions z ! ,adm9i/rator may specify2 7#c7 ! ,adm9i/rator det]m9es t disclosure is necess>y to protect 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 #a or m applicable agreem5ts ) ! ,adm9i/rator t con=m ) ! guidance issu$ "u subsection 7d77#c77;,b7 ensure t ! recipi5t w take appropriate measures1 & has adequate au?ority1 to ma9ta9 ! confid5tiality ( ! in=mation 9 accordance ) proc$ures comp>able to ! proc$ures us$ by ! ,adm9i/rator to safegu>d ! in=mation2 & 7,b7 ! ,adm9i/rator notifies ! p]son t submitt$ ! in=mation t ! in=mation has be5 disclos$ to ! ,/ate or political subdivision ( a ,/ate2 7#e7 a heal? or environm5tal pr(essional employ$ by a ,f$]al or ,/ate ag5cy or a treat+ physician or nurse 9 a nonem]g5cy situation provides a writt5 /atem5t ( ne$ & agrees to sign a writt5 confid5tiality agreem5t ) ! ,adm9i/rator1 subject to ! conditions t-- 7,a7 ! /atem5t ( ne$ & confid5tiality agreem5t %all con=m ) ! guidance issu$ "u subsection 7d77#c77;,b72 7,b7 ! writt5 /atem5t ( ne$ %all be a /atem5t t ! p]son has a reasonable basis to suspect t-- 7i7 ! in=mation is necess>y =1 or w assi/ 9-- 7,i7 ! diagnosis or treatm5t ( #a or m individuals2 or 7,,ii7 respond+ to an environm5tal release or exposure2 & 7ii7 #a or m individuals be+ diagnos$ or treat$ h be5 expos$ to ! *emical sub/ance conc]n$1 or an environm5tal release or exposure has occurr$2 & 7,c7 ! confid5tiality agreem5t %all provide t ! p]son w n use ! in=mation = any purpose o!r ?an ! heal? or environm5tal ne$s ass]t$ 9 ! /atem5t ( ne$1 except z o!rwise may be au?oriz$ by ! t]ms ( ! agreem5t or by ! p]son submitt+ ! in=mation to ! ,adm9i/rator1 except t no?+ 9 ?is ,act prohibits ! disclosure ( any su* in=mation ?r\gh discov]y1 subpo5a1 o!r c\rt ord]1 or any o!r judicial process o!rwise all[$ "u applicable ,f$]al or ,/ate law2 7#f7 9 ! ev5t ( an em]g5cy1 a treat+ physician1 nurse1 ag5t ( a poison control c5t]1 public heal? or environm5tal (ficial ( a ,/ate or political subdivision ( a ,/ate1 or fir/ respond] 7includ+ any individual duly au?oriz$ by a ,f$]al ag5cy1 ,/ate1 or political subdivision ( a ,/ate :o is tra9$ 9 urg5t m$ical c>e or o!r em]g5cy proc$ures1 includ+ a police (fic]1 firefight]1 or em]g5cy m$ical te*nician7 reque/s ! in=mation1 subject to ! conditions t-- 7,a7 ! treat+ physician1 nurse1 ag5t1 public heal? or environm5tal (ficial ( a ,/ate or a political subdivision ( a ,/ate1 or fir/ respond] %all h a reasonable basis to suspect t-- 7i7 a m$ical or public heal? or environm5tal em]g5cy exi/s2 7ii7 ! in=mation is necess>y =1 or w assi/ 91 em]g5cy or fir/-aid diagnosis or treatm5t2 or 7iii7 #a or m individuals be+ diagnos$ or treat$ h likely be5 expos$ to ! *emical sub/ance conc]n$1 or a s]i\s environm5tal release ( or exposure to ! *emical sub/ance conc]n$ has occurr$2 7,b7 if reque/$ by ! p]son submitt+ ! in=mation to ! ,adm9i/rator1 ! treat+ physician1 nurse1 ag5t1 public heal? or environm5tal (ficial ( a ,/ate or a political subdivision ( a ,/ate1 or fir/ respond] %all1 z describ$ 9 p>agraph 7#e7-- 7i7 provide a writt5 /atem5t ( ne$2 & 7ii7 agree to sign a confid5tiality agreem5t2 & 7,c7 ! writt5 confid5tiality agreem5t or /atem5t ( ne$ %all be submitt$ z soon z practicable1 b n necess>ily be=e ! in=mation is disclos$2 7#g7 ! ,adm9i/rator det]m9es t disclosure is relevant 9 a proce$+ "u ?is ,act1 subject to ! condition t ! disclosure %all be made 9 su* a mann] z to pres]ve confid5tiality to ! maximum ext5t practicable )\t impair+ ! proce$+2 7#h7 ! in=mation is to be disclos$1 on writt5 reque/ ( any duly au?oriz$ congressional committee1 to t committee2 or 7#i7 ! in=mation is requir$ to be disclos$ or o!rwise made public "u any o!r provision ( ,f$]al law4 7f7 ,duration ( protection f disclosure 7#a7 ,9 g5]al 7,a7 ,in=mation protect$ f disclosure ,subject to p>agraph 7#b71 ! ,adm9i/rator %all protect f disclosure in=mation t meets ! requirem5ts ( subsection 7d7 = a p]iod ( #aj ye>s1 unless1 prior to ! expiration ( ! p]iod-- 7i7 an affect$ p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7ii7 ! ,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 ,ext5sions 7i7 ,9 g5]al ,n lat] ?an ! date t is #fj days be=e ! expiration ( ! p]iod describ$ 9 subp>agraph 7,a71 ! ,adm9i/rator %all provide to ! p]son t ass]t$ ! claim a notice ( ! imp5d+ expiration ( ! p]iod4 7ii7 ,/atem5t 7,i7 ,9 g5]al ,n lat] ?an ! date t is #cj days be=e ! expiration ( ! p]iod describ$ 9 subp>agraph 7,a71 a p]son reass]t+ ! relevant claim %all submit to ! ,adm9i/rator a /atem5t sub/antiat+1 9 accordance ) subsection 7d77#b71 ! ne$ to ext5d ! p]iod4 7,,ii7 ,action by ,adm9i/rator ,n lat] ?an ! date t is #cj days aft] ! date ( receipt ( a /atem5t "u subclause 7,i71 ! ,adm9i/rator %all-- 7aa7 review ! reque/2 7bb7 make a det]m9ation reg>d+ :e!r ! in=mation = :i* ! reque/ is made cont9ues to meet ! relevant crit]ia e/abli%$ "u ?is section2 & 7cc7 7,,aa7 grant an ext5sion ( n m ?an #aj ye>s2 or 7,,bb7 d5y ! claim4 7,c7 ,no limit on numb] ( ext5sions ,!re %all be no limit on ! numb] ( ext5sions grant$ "u subp>agraph 7,b71 if ! ,adm9i/rator det]m9es t ! relevant /atem5t "u subp>agraph 7,b77ii77,i7-- 7i7 e/abli%es ! ne$ to ext5d ! p]iod2 & 7ii7 meets ! requirem5ts e/abli%$ by ! ,adm9i/rator4 7#b7 ,review & resub/antiation 7,a7 ,discretion ( ,adm9i/rator ,! ,adm9i/rator may review1 at any "t1 a claim = protection aga9/ disclosure "u subsection 7a7 = in=mation submitt$ to ! ,adm9i/rator reg>d+ a *emical sub/ance & require any p]son t has claim$ protection = t in=mation1 :e!r be=e1 on1 or aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 to )draw or reass]t & sub/antiate or resub/antiate ! claim 9 accordance ) ?is section-- 7i7 aft] ! *emical sub/ance is id5tifi$ z a high-priority sub/ance "u section #d;,a2 7ii7 = any *emical sub/ance = :i* ! ,adm9i/rator has made a det]m9ation "u section #f7;c77#a77;,c72 7iii7 = any inactive *emical sub/ance id5tifi$ "u section #h7;b77#e72 or 7iv7 9 limit$ circum/ances1 if ! ,adm9i/rator det]m9es t disclosure ( c]ta9 in=mation curr5tly protect$ f disclosure w\ld assi/ ! ,adm9i/rator 9 conduct+ safety assessm5ts & safety det]m9ations "u subsections 7b7 & 7c7 ( section #f or promulgat+ rules pursuant to section #f7;d71 subject to ! condition t ! in=mation %all n be disclos$ unless ! claimant )draws ! claim or ! ,adm9i/rator det]m9es t ! in=mation does n meet ! requirem5ts ( subsection 7d74 7,b7 ,review requir$ ,! ,adm9i/rator %all review a claim = protection f disclosure "u subsection 7a7 = in=mation submitt$ to ! ,adm9i/rator reg>d+ a *emical sub/ance & require any p]son t has claim$ protection = t in=mation1 :e!r be=e1 on1 or aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 to )draw or reass]t & sub/antiate or resub/antiate ! claim 9 accordance ) ?is section-- 7i7 z necess>y to comply ) a reque/ = in=mation receiv$ by ! ,adm9i/rator "u section #eeb ( title #e1 ,unit$ ,/ates ,code2 7ii7 if in=mation available to ! ,adm9i/rator provides a basis t ! requirem5ts ( section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 are no long] met2 or 7iii7 = any sub/ance = :i* ! ,adm9i/rator has made a det]m9ation "u section #f7;c77#a77;,b74 7,c7 ,action by recipi5t ,if ! ,adm9i/rator makes a reque/ "u subp>agraph 7,a7 or 7,b71 ! recipi5t ( ! reque/ %all-- 7i7 reass]t & sub/antiate or resub/antiate ! claim2 or 7ii7 )draw ! claim4 7,d7 ,p]iod ( protection ,protection f disclosure ( in=mation subject to a claim t is review$ & approv$ by ! ,adm9i/rator "u ?is p>agraph %all be ext5d$ = a p]iod ( #aj ye>s f ! date ( approval1 subject to any subsequ5t reque/ by ! ,adm9i/rator "u ?is p>agraph4 7#c7 ,unique id5tifi] ,! ,adm9i/rator %all-- 7,a7 7i7 develop a sy/em to assign a unique id5tifi] to ea* specific *emical id5tity = :i* ! ,adm9i/rator approves a reque/ = protection f disclosure1 o!r ?an a specific *emical id5tity or /ructurally descriptive g5]ic t]m2 & 7ii7 apply t id5tifi] consi/5tly to all in=mation relevant to ! applicable *emical sub/ance2 7,b7 annually publi% & update a li/ ( *emical sub/ances1 ref]r$ to by unique id5tifi]1 = :i* claims to protect ! specific *emical id5tity f disclosure h be5 approv$1 includ+ ! expiration date = ea* su* claim2 7,c7 ensure t any nonconfid5tial in=mation receiv$ by ! ,adm9i/rator ) respect to su* a *emical sub/ance dur+ ! p]iod ( protection f disclosure-- 7i7 is made public2 & 7ii7 id5tifies ! *emical sub/ance us+ ! unique id5tifi]2 & 7,d7 = ea* claim = protection ( specific *emical id5tity t has be5 d5i$ by ! ,adm9i/rator on expiration ( ! p]iod = appeal "u subsection 7g77#c71 t has expir$1 or t has be5 )drawn by ! submitt]1 provide public access to ! specific *emical id5tity cle>ly l9k$ to all nonconfid5tial in=mation receiv$ by ! ,adm9i/rator ) respect to ! *emical sub/ance4 7g7 ,duties ( ,adm9i/rator 7#a7 ,det]m9ation 7,a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 ! ,adm9i/rator %all1 subject to subp>agraph 7,c71 n lat] ?an #ij days aft] ! receipt ( a claim "u subsection 7d71 & n lat] ?an #cj days aft] ! receipt ( a reque/ = ext5sion ( a claim "u subsection 7f71 review & approve1 modify1 or d5y ! claim or reque/4 7,b7 ,d5ial or modification 7i7 ,9 g5]al ,except z provid$ 9 subsections 7c7 & 7f71 ! ,adm9i/rator %all d5y a claim to protect a *emical id5tity f disclosure only if ! p]son t has submitt$ ! claim fails to meet ! requirem5ts ( subsections 7a7 & 7d74 7ii7 ,reasons = d5ial or modification ,! ,adm9i/rator %all provide to a p]son t has submitt$ a claim describ$ 9 clause 7i7 a writt5 /atem5t ( ! reasons = ! d5ial or modification ( ! claim4 7,c7 ,subsets ,! ,adm9i/rator %all-- 7i7 except = claims describ$ 9 subsection 7b77#g71 review all claims "u ?is section = ! protection aga9/ disclosure ( ! specific id5tity ( a *emical sub/ance2 & 7ii7 review a repres5tative subset1 compris+ at lea/ #be p]c5t1 ( all o!r claims = protection aga9/ disclosure4 7,d7 ,effect ( failure to act ,! failure ( ! ,adm9i/rator to make a decision reg>d+ a claim = protection aga9/ disclosure or ext5sion "u ?is section %all n be ! basis = d5ial or elim9ation ( a claim = protection aga9/ disclosure4 7#b7 ,notification 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b7 & subsections 7c71 7e71 & 7f71 if ! ,adm9i/rator d5ies or modifies a claim "u p>agraph 7#a71 ! ,adm9i/rator %all notify1 9 writ+ & by c]tifi$ mail1 ! p]son t submitt$ ! claim ( ! int5t ( ! ,adm9i/rator to release ! in=mation4 7,b7 ,release ( in=mation 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 ! ,adm9i/rator %all n release in=mation "u ?is subsection until ! date t is #cj days aft] ! date on :i* ! p]son t 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 %all n release t in=mation until ! date t is #ae days aft] ! date on :i* ! p]son t submitt$ ! claim 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 heal? or ! environm5t1 9 :i* case no prior notification %all be necess>y4 7,,ii7 ,no notification ,= in=mation "u p>agraph 7#a71 7#b71 7#f71 7#g71 or 7#i7 ( subsection 7e71 no prior notification %all be necess>y4 7#c7 ,appeals 7,a7 ,9 g5]al ,if a p]son receives a notification "u p>agraph 7#b7 & believes disclosure ( ! in=mation is prohibit$ "u subsection 7a71 be=e ! date on :i* ! in=mation is to be releas$1 ! p]son may br+ an action to re/ra9 disclosure ( ! in=mation 9-- 7i7 ! ,unit$ ,/ates di/rict c\rt ( ! di/rict 9 :i* ! compla9ant resides or has ! pr9cipal place ( bus9ess2 or 7ii7 ! ,unit$ ,/ates ,di/rict ,c\rt = ! ,di/rict ( ,columbia4 7,b7 ,no disclosure ,! ,adm9i/rator %all n disclose any in=mation t is ! subject ( an appeal "u ?is section be=e ! 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 use ! proc$ures describ$ 9 "p #b ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations74 7h7 ,crim9al p5alty = wrongful disclosure 7#a7 ,(fic]s & employees ( ,unit$ ,/ates 7,a7 ,9 g5]al ,subject to p>agraph 7#b71 a curr5t or =m] (fic] or employee ( ! ,unit$ ,/ates describ$ 9 subp>agraph 7,b7 %all be guilty ( a misdemeanor & f9$ "u title #ah1 ,unit$ ,/ates ,code1 or imprison$ = n m ?an #a ye>1 or bo?4 7,b7 ,description ,a curr5t or =m] (fic] or employee ( ! ,unit$ ,/ates ref]r$ to 9 subp>agraph 7,a7 is a curr5t or =m] (fic] or employee ( ! ,unit$ ,/ates :o-- 7i7 by virtue ( t employm5t or (ficial position has obta9$ possession (1 or has access to1 mat]ial ! disclosure ( :i* is prohibit$ by subsection 7a72 & 7ii7 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]ial4 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 t is provid$ in=mation 9 accordance ) subsection 7e77#b71 includ+ any employee ( t contractor1 %all be consid]$ to be an employee ( ! ,unit$ ,/ates4 7i7 ,applicability 7#a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 section #h1 or any o!r applicable ,f$]al law1 ! ,adm9i/rator %all h no au?ority-- 7,a7 to require ! sub/antiation or resub/antiation ( a claim = ! protection f disclosure ( in=mation submitt$ to ! ,adm9i/rator "u ?is ,act be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act2 or 7,b7 to impose sub/antiation or resub/antiation requirem5ts "u ?is ,act t are m ext5sive ?an ^? requir$ "u ?is section4 7#b7 ,prior actions ,no?+ 9 ?is ,act prev5ts ! ,adm9i/rator f review+1 requir+ sub/antiation or resub/antiation =1 or approv+1 modify+ or d5y+ any claim = ! protection f disclosure ( in=mation be=e ! effective date ( su* rules applicable to ^? claims z ! ,adm9i/rator may promulgate aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 4 #af4 ,prohibit$ acts ,section #ae ( ! ,toxic ,sub/ances ,control ,act 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 "u section #e or #f2 7,c7 any rule promulgat$1 cons5t agreem5t ent]$ into1 or ord] issu$ "u section #e or #f2 or 7,d7 any requirem5t (1 or any rule promulgat$ or ord] issu$ pursuant to title ,,ii2 4 #ag4 ,p5alties ,section #af ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfae7 is am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 9 ! fir/ s5t5ce-- 7i7 by ins]t+ ?is ,act or a rule or ord] promulgat$ or issu$ pursuant to ?is ,act1 includ+ aft] a provision (2 & 7ii7 by /rik+ #be1jjj & ins]t+ #cg1ejj2 & 7,b7 9 ! second s5t5ce1 by /rik+ violation ( section #ae or #dji & ins]t+ violation ( ?is ,act2 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ ,any p]son :o & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,any p]son t 2 7,b7 by /rik+ section #ae or #dji & ins]t+ ?is ,act2 7,c7 by /rik+ #be1jjj & ins]t+ #ej1jjj2 & 7,d7 by add+ at ! end ! foll[+3 7#b7 ,imm95t dang] ( dea? or s]i\s bodily injury 7,a7 ,9 g5]al ,any p]son t kn[+ly or willfully violates any provision ( ?is ,act1 & t kn[s at ! "t ( ! violation t ! violation places an individual 9 imm95t dang] ( dea? or s]i\s bodily injury1 %all be subject on conviction to a f9e ( n m ?an #bej1jjj1 or imprisonm5t = n m ?an #ae ye>s1 or bo?4 7,b7 ,organizations ,an organization t commits a violation describ$ 9 subp>agraph 7,a7 %all be subject on conviction to a f9e ( n m ?an #a1jjj1jjj = ea* violation4 7#c7 ,k ( imm95t dang] or injury ,= purposes ( det]m9+ :e!r a def5dant knew t ! violation plac$ ano!r individual 9 imm95t dang] ( dea? or s]i\s bodily injury-- 7,a7 ! def5dant %all be responsible only = actual aw>5ess or actual belief possess$2 & 7,b7 k possess$ by an individual may n be attribut$ to ! def5dant4 4 #ah4 ,/ate-,f$]al relation%ip ,section #ah ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfag7 is am5d$ by /rik+ subsections 7a7 & 7b7 & ins]t+ ! foll[+3 7a7 ,9 g5]al 7#a7 ,e/abli%m5t or en=cem5t ,except z provid$ 9 subsections 7c71 7d71 7e71 7f71 & 7g71 & subject to p>agraph 7#b71 no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue to en=ce any ( ! foll[+3 7,a7 ,te/+ & in=mation collection ,a /atute or adm9i/rative action to require ! developm5t ( in=mation on a *emical sub/ance or category ( sub/ances t is reasonably likely to produce ! same in=mation requir$ "u section #d1 #e1 or #f 9-- 7i7 a rule promulgat$ by ! ,adm9i/rator2 7ii7 a te/+ cons5t agreem5t ent]$ into by ! ,adm9i/rator2 or 7iii7 an ord] issu$ by ! ,adm9i/rator4 7,b7 ,*emical sub/ances f\nd to meet ! safety /&>d or re/rict$ ,a /atute or adm9i/rative action to prohibit or o!rwise re/rict ! manufacture1 process+1 or di/ribution 9 comm]ce or use ( a *emical sub/ance-- 7i7 f\nd to meet ! safety /&>d & consi/5t ) ! scope ( ! det]m9ation made "u section #f2 or 7ii7 f\nd n to meet ! safety /&>d1 aft] ! effective date ( ! rule issu$ "u section #f7;d7 = ! sub/ance1 consi/5t ) ! scope ( ! det]m9ation made by ! ,adm9i/rator4 7,c7 ,significant new use ,a /atute or adm9i/rative action requir+ ! 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 7#b7 ,effective date ( preemption ,"u ?is subsection1 ,f$]al preemption ( ,/ate /atutes & adm9i/rative actions applicable to specific sub/ances %all n occur until ! effective date ( ! applicable action describ$ 9 p>agraph 7#a7 tak5 by ! ,adm9i/rator4 7b7 ,new /atutes or adm9i/rative actions creat+ prohibitions or o!r re/rictions ,except z provid$ 9 subsections 7c71 7d71 & 7e71 no ,/ate or political subdivision ( a ,/ate may e/abli% 7aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act7 a /atute or adm9i/rative action prohibit+ or re/rict+ ! manufacture1 process+1 di/ribution 9 comm]ce or use ( a *emical sub/ance t is a high-priority sub/ance designat$ "u section #d;,a1 z ( ! date on :i* ! ,adm9i/rator comm5ces a safety assessm5t "u section #f4 7c7 ,scope ( preemption ,f$]al preemption "u subsections 7a7 & 7b7 ( ,/ate /atutes & adm9i/rative actions applicable to specific sub/ances %all apply only to-- 7#a7 ! *emical sub/ances or category ( sub/ances subject to a rule1 ord]1 or cons5t agreem5t "u section #d2 7#b7 ! uses or conditions ( use ( su* sub/ances t are id5tifi$ by ! ,adm9i/rator z subject to review 9 a safety assessm5t & includ$ 9 ! scope ( ! safety det]m9ation made by ! ,adm9i/rator = ! sub/ance1 or ( any rule ! ,adm9i/rator promulgates pursuant to section #f7;d72 or 7#c7 ! uses ( su* sub/ances t ! ,adm9i/rator has specifi$ z significant new uses & = :i* ! ,adm9i/rator has requir$ notification pursuant to a rule promulgat$ "u section #e4 7d7 ,exceptions 7#a7 ,9 g5]al ,subsections 7a7 & 7b7 %all n apply to a /atute or adm9i/rative action ( a ,/ate or a political subdivision ( a ,/ate applicable to a specific *emical sub/ance t-- 7,a7 is adopt$ "u ! au?ority (1 or au?oriz$ to comply )1 any o!r ,f$]al law2 7,b7 implem5ts a report+1 monitor+1 or o!r in=mation collection obligation = ! *emical sub/ance n o!rwise requir$ 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 disposal1 unless ! action tak5 by ! ,/ate or political subdivision ( a ,/ate-- 7i7 imposes a re/riction on ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance2 & 7ii7 7,i7 is already requir$ by a decision by ! ,adm9i/rator "u section #e or #f2 7,,ii7 is tak5 to address a heal? or environm5tal conc]n t applies to ! uses or conditions ( use t are includ$ 9 ! scope ( a safety det]m9ation pursuant to section #f or ! scope ( a significant new use rule promulgat$ pursuant to section #e1 b is inconsi/5t ) ! action ( ! ,adm9i/rator2 or 7,,iii7 w\ld cause a violation ( ! applicable action by ! ,adm9i/rator "u section #e or #f4 7#b7 ,no preemption ( ,/ate /atutes & adm9i/rative actions ,no?+ 9 ?is ,act1 nor any am5dm5t made by ?is ,act1 nor any rule1 /&>d ( p]=mance1 safety det]m9ation1 or sci5tific assessm5t implem5t$ pursuant to ?is ,act1 %all affect ! "r ( a ,/ate or a political subdivision ( a ,/ate to adopt or en=ce any rule1 /&>d ( p]=mance1 safety det]m9ation1 sci5tific assessm5t1 or any protection = public heal? or ! environm5t t-- 7,a7 is adopt$ "u ! au?ority (1 or au?oriz$ to comply )1 any o!r ,f$]al law2 7,b7 implem5ts a report+1 monitor+1 or o!r in=mation collection obligation = ! *emical sub/ance n o!rwise requir$ 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 disposal1 unless ! action tak5 by ! ,/ate or political subdivision ( a ,/ate-- 7i7 imposes a re/riction on ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance2 & 7ii7 7,i7 is already requir$ by a decision by ! ,adm9i/rator "u section #e or #f2 7,,ii7 is tak5 to address a heal? or environm5tal conc]n t applies to ! uses or conditions ( use t are includ$ 9 ! scope ( a safety det]m9ation pursuant to section #f or ! scope ( a significant new use rule promulgat$ pursuant to section #e1 b is inconsi/5t ) ! action ( ! ,adm9i/rator2 or 7,,iii7 w\ld cause a violation ( ! applicable action by ! ,adm9i/rator "u section #e or #f4 7#c7 ,applicability to c]ta9 rules or ord]s ,not)/&+ subsection 7e7-- 7,a7 no?+ 9 ?is section %all be con/ru$ z modify+ ! effect "u ?is section1 z 9 effect on ! day be=e ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ( any rule or ord] promulgat$ or issu$ "u ?is ,act prior to t effective date2 & 7,b7 ) respect to a *emical sub/ance or mixture = :i* any rule or ord] 0 promulgat$ or issu$ "u section #f prior to ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act ) reg>ds to manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance1 ?is section 7z 9 effect on ! day be=e ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act7 %all gov]n ! preemptive effect ( any rule or ord] t is promulgat$ or issu$ respect+ su* *emical sub/ance or mixture "u section #f ( ?is ,act aft] t effective date1 unless ! latt] rule or ord] is ) respect to a *emical sub/ance or mixture conta9+ a *emical sub/ance & foll[s a designation ( t *emical sub/ance z a high-priority sub/ance "u subsection 7b7 or 7c7 ( section #d;,a or z an additional priority = safety assessm5t & safety det]m9ation "u section #d;,a7d74 7e7 ,pres]vation ( c]ta9 ,/ate law 7#a7 ,9 g5]al ,no?+ 9 ?is ,act1 subject to subsection 7g7 ( ?is section1 %all-- 7,a7 be con/ru$ to preempt or o!rwise affect any action tak5 be=e ,janu>y #a1 #bjae1 "u ! au?ority ( a ,/ate law t prohibits or o!rwise re/ricts manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance2 or 7,b7 be con/ru$ to preempt or o!rwise affect any action tak5 pursuant to a ,/ate law t 0 9 effect on ,augu/ #ca1 #bjjc4 7#b7 ,effect ( subsection ,?is subsection does n affect1 modify1 or alt] ! relation%ip betwe5 ,/ate & ,f$]al law pursuant to any o!r ,f$]al law4 7f7 ,/ate waiv]s 7#a7 ,9 g5]al ,^u application ( a ,/ate or political subdivision ( a ,/ate1 ! ,adm9i/rator may-- 7,a7 by rule1 exempt f subsection 7a71 "u su* conditions z may be prescrib$ 9 ! rule1 a /atute or adm9i/rative action ( t ,/ate or political subdivision ( ! ,/ate t relates to ! effects (1 or exposure to1 a *emical sub/ance "u ! conditions ( use if ! ,adm9i/rator det]m9es t-- 7i7 compell+ ,/ate or local conditions w>rant grant+ ! waiv] to protect heal? or ! environm5t2 7ii7 compliance ) ! propos$ requirem5t ( ! ,/ate or political subdivision ( ! ,/ate w\ld n unduly burd5 int]/ate 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$]al law1 rule1 or ord]2 & 7iv7 bas$ on ! judgm5t ( ! ,adm9i/rator1 ! propos$ requirem5t ( ! ,/ate or political subdivision ( ! ,/ate is consi/5t ) s\nd objective sci5tific practices1 ! weight ( ! evid5ce1 & ! be/ available sci5ce2 or 7,b7 exempt f subsection 7b7 a /atute or adm9i/rative action ( a ,/ate or political subdivision ( a ,/ate t relates to ! effects ( exposure to a *emical sub/ance "u ! conditions ( use if ! ,adm9i/rator det]m9es t-- 7i7 ! ,/ate has a compell+ local int]e/ t w>rants grant+ ! waiv] to protect heal? or ! environm5t2 7ii7 compliance ) ! propos$ requirem5t ( ! ,/ate w n unduly burd5 int]/ate 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#b7 ,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#a77;,a7 is submitt$2 & 7,b7 n lat] ?an #ij days aft] ! date on :i* an application "u p>agraph 7#a77;,b7 is submitt$4 7#c7 ,notice & comm5t ,! application ( a ,/ate or political subdivision ( ! ,/ate %all be subject to public notice & comm5t4 7#d7 ,f9al ag5cy action ,! decision ( ! ,adm9i/rator on ! application ( a ,/ate or political subdivision ( ! ,/ate %all be-- 7,a7 consid]$ to be a f9al ag5cy action2 & 7,b7 subject to judicial review4 7#e7 ,duration ( waiv]s ,a waiv] grant$ "u p>agraph 7#a77;,b7 %all rema9 9 effect until ! lat] (-- 7,a7 su* "t z ! safety assessm5t & safety det]m9ation is complet$2 & 7,b7 ! date on :i* compliance ) an applicable rule issu$ "u section #f7;d7 is requir$4 7#f7 ,judicial review ( waiv]s ,n lat] ?an #fj days aft] ! date on :i* ! ,adm9i/rator makes a det]m9ation on an application ( a ,/ate or political subdivision ( ! ,/ate "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a71 any p]son may file a petition = judicial review 9 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit1 :i* %all h exclusive jurisdiction ov] ! det]m9ation4 7#g7 ,judicial review ( prioritization scre5+ decision ,n lat] ?an #fj days aft] ! date on :i* ! ,adm9i/rator makes a decision on a recomm5dation made "u section #d;,a7b77#d7 to designate a *emical sub/ance z a l[ priority1 ! ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? & ! environm5t t submitt$ ! recomm5dation "u section #d;,a7a77#d77;,a71 z applicable1 may file a petition = judicial review 9 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit1 :i* %all h exclusive jurisdiction ov] ! det]m9ation4 7g7 ,sav+s 7#a7 ,no preemption ( common law or /atutory causes ( action = civil relief or crim9al conduct 7,a7 ,9 g5]al ,no?+ 9 ?is ,act1 nor any am5dm5t made by ?is ,act1 nor any safety /&>d1 rule1 requirem5t1 /&>d ( p]=mance1 safety det]m9ation1 or sci5tific assessm5t implem5t$ pursuant to ?is ,act1 %all be con/ru$ to preempt1 displace1 or supplant any /ate or ,f$]al common law rights or any /ate or ,f$]al /atute creat+ a rem$y = civil relief1 includ+ ^? = civil damage1 or a p5alty = a crim9al conduct4 7,b7 ,cl>ification ( no preemption ,not)/&+ any o!r provision ( ?is ,act1 no?+ 9 ?is ,act1 nor any am5dm5ts made by ?is ,act1 %all preempt or preclude any cause ( action = p]sonal injury1 wrongful dea?1 prop]ty damage1 or o!r injury bas$ on neglig5ce1 /rict liability1 products liability1 failure to w>n1 or any o!r legal !ory ( liability "u any ,/ate law1 m>itime law1 or ,f$]al common law or /atutory !ory4 7#b7 ,no effect on private rem$ies 7,a7 ,no?+ 9 ?is ,act1 nor any am5dm5ts made by ?is ,act1 nor any rules1 regulations1 requirem5ts1 safety assessm5ts1 safety det]m9ations1 sci5tific assessm5ts1 or ord]s issu$ pursuant to ?is ,act %all be int]pret$ z1 9 ei!r ! pla9tiff's or def5dant's favor1 dispositive 9 any civil action4 7,b7 ,?is ,act does n affect ! au?ority ( any c\rt to make a det]m9ation 9 an adjudicatory proce$+ "u applicable ,/ate or ,f$]al law ) respect to ! admission into evid5ce or any o!r use ( ?is ,act or rules1 regulations1 requirem5ts1 /&>ds ( p]=mance1 safety assessm5ts1 sci5tific assessm5ts1 or ord]s issu$ pursuant to ?is ,act4 4 #ai4 ,judicial review ,section #ai ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfah7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,a71 by /rik+ section #d7;a71 #e7;a77#b71 #e7;b77#d71 #f7;a71 #f7;e71 or #h1 or "u title ,,ii or ,,iv & ins]t+ section #d7;a71 #e7;d71 #f7;c71 #f7;d71 #f7;g71 or #h1 or title ,,ii or ,,iv2 & 7ii7 9 subp>agraph 7,b71 by /rik+ an ord] issu$ "u subp>agraph 7,a7 or 7,b7 ( section #f7;b77#a7 & ins]t+ an ord] issu$ "u ?is title2 & 7,b7 9 p>agraph 7#b71 9 ! fir/ s5t5ce1 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#a77;,b7-- 7,a7 9 clause 7i7-- 7i7 by /rik+ section #d7;a71 #e7;b77#d71 #f7;a71 or #f7;e7 & ins]t+ section #d7;a71 #e7;d71 #f7;d71 or #f7;g72 & 7ii7 by /rik+ evid5ce 9 ! rulemak+ record 7z def9$ 9 subsection 7a77#c77 tak5 z a :ole2 & ins]t+ evid5ce 7includ+ any matt]7 9 ! rulemak+ record1 tak5 z a :ole2 &2 & 7,b7 by /rik+ clauses 7ii7 & 7iii7 & ! matt] foll[+ clause 7iii7 & ins]t+ ! foll[+3 7ii7 ! c\rt may n review ! cont5ts & adequacy ( any /atem5t ( basis & purpose requir$ by section #eec7;c7 ( title #e1 ,unit$ ,/ates ,code1 to be incorporat$ 9 ! rule1 except z "p ( ! rulemak+ record1 tak5 z a :ole4 4 #bj4 ,citiz5s' petitions ,section #ba ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbj7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ an ord] "u section #e7;e7 or #f7;b77#b7 & ins]t+ an ord] "u section #d or #e7;d72 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by /rik+ an ord] "u section #e7;e71 #f7;b77#a77;,a71 or #f7;b77#a77;,b7 & ins]t+ an ord] "u section #d or #e7;d72 & 7,b7 9 p>agraph 7#d71 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,de novo proce$+ 7i7 ,9 g5]al ,9 an action "u subp>agraph 7,a7 to initiate a proce$+ to promulgate a rule pursuant to section #d1 #e1 #f1 or #h or an ord] issu$ "u section #d or #e1 ! petition] %all be provid$ an opportunity to h ! petition consid]$ by ! c\rt 9 a de novo proce$+4 7ii7 ,demon/ration 7,i7 ,9 g5]al ,! c\rt 9 a de novo proce$+ "u ?is subp>agraph %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$+ = ! issuance ( a rule or ord] "u section #d1 ! in=mation available to ! ,adm9i/rator is insuffici5t = ! ,adm9i/rator to p]=m an action describ$ 9 section #d1 #d;,a1 #e1 or #f7;d72 7bb7 9 ! case ( a petition to issue an ord] "u section #e7;d71 !re is a reasonable basis to conclude t ! *emical sub/ance is n likely to meet ! safety /&>d2 7cc7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #f7;d71 !re is a reasonable basis to conclude t ! *emical sub/ance w n meet ! safety /&>d2 or 7dd7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #h1 !re is a reasonable basis to conclude t ! rule is necess>y to protect heal? or ! environm5t or ensure t ! *emical sub/ance meets ! safety /&>d4 7,,ii7 ,def]m5t ,! c\rt 9 a de novo proce$+ "u ?is subp>agraph may p]mit ! ,adm9i/rator to def] initiat+ ! action reque/$ by ! petition] until su* "t z ! c\rt prescribes1 if ! c\rt f9ds t-- 7aa7 ! ext5t ( ! risk to heal? or ! environm5t alleg$ by ! petition] is less ?an ! ext5t ( risks to 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 #ba4 ,employm5t effects ,section #bd7;b77#b77;,b77ii7 ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbc7;b77#b77;,b77ii77 is am5d$ by /rik+ section #f7;c77#c71 & ins]t+ ! applicable requirem5ts ( ?is ,act24 #bb4 ,/udies ,section #be ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbd7 is repeal$4 #bc4 ,adm9i/ration ,section #bf ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbe7 is am5d$-- 7#a7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,fees 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli%1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 by rule-- 7,a7 ! paym5t ( #a or m reasonable fees z a condition ( submitt+ a notice or reque/+ an exemption "u section #e2 & 7,b7 ! paym5t ( #a or m reasonable fees by a manufactur] or processor t-- 7i7 is requir$ to submit a notice pursuant to ! rule promulgat$ "u section #h7;b77#d77;,a77i7 id5tify+ a *emical sub/ance z active2 7ii7 is requir$ to submit a notice pursuant to section #h7;b77#e77;,b77i7 *ang+ ! /atus ( a *emical sub/ance f inactive to active2 7iii7 is requir$ to report in=mation pursuant to ! rules promulgat$ "u section #h7;a77#d72 & 7iv7 manufactures or processes a *emical sub/ance subject to a safety assessm5t & safety det]m9ation pursuant to section #f4 7#b7 ,utilization & collection ( fees ,! ,adm9i/rator %all-- 7,a7 utilize ! fees collect$ "u p>agraph 7#a7 only to defray co/s associat$ ) ! actions ( ! ,adm9i/rator-- 7i7 to collect1 process1 review1 provide access to1 & protect f disclosure 7:]e appropriate7 in=mation on *emical sub/ances "u ?is ,act2 7ii7 to review notices & make det]m9ations = *emical sub/ances "u p>agraphs 7#a7 & 7#c7 ( section #e7;d7 & impose any necess>y re/rictions "u section #e7;d77#d72 7iii7 to make prioritization decisions "u section #d;,a2 7iv7 to conduct & complete safety assessm5ts & det]m9ations "u section #f2 & 7v7 to conduct any necess>y rulemak+ pursuant to section #f7;d72 7,b7 ins(> z possible1 collect ! fees describ$ 9 p>agraph 7#a7 9 advance ( conduct+ any fee-support$ activity2 7,c7 deposit ! fees 9 ! ,fund e/abli%$ by p>agraph 7#d77;,a72 & 7,d7 n collect excess fees or reta9 a significant am\nt ( unus$ fees4 7#c7 ,am\nt & adju/m5t ( fees2 refunds ,9 sett+ fees "u ?is section1 ! ,adm9i/rator %all-- 7,a7 take into acc\nt ! co/ to ! ,adm9i/rator ( conduct+ ! activities describ$ 9 p>agraph 7#b72 7,b7 prescribe l[] fees = small bus9ess conc]ns1 aft] consultation ) ! ,adm9i/rator ( ! ,small ,bus9ess ,adm9i/ration2 7,c7 set ! fees e/abli%$ "u p>agraph 7#a7 at levels su* t ! fees w1 9 aggregate1 provide a su/a9able s\rce ( funds to defray approximately #be p]c5t ( ! co/s ( conduct+ ! activities id5tifi$ 9 p>agraph 7#b77;,a71 n to exce$ #ah1jjj1jjj1 n includ+ fees "u subp>agraph 7,e7 ( ?is p>agraph2 7,d7 reflect an appropriate balance 9 ! assessm5t ( fees betwe5 manufactur]s & processors1 & all[ ! paym5t ( fees by consortia ( manufactur]s or processors2 7,e7 = sub/ances designat$ z additional priorities pursuant to section #d;,a7c71 e/abli% ! fee at a level suffici5t to defray ! full co/s to ! ,adm9i/rator ( conduct+ ! safety assessm5t & safety det]m9ation "u section #f2 7,f7 prior to ! e/abli%m5t or am5dm5t ( any fees "u p>agraph 7#a71 consult & meet ) p>ties pot5tially subject to ! fees or _! repres5tatives1 subject to ! condition t no obligation "u ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 or sub*apt] ,,iii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 is applicable ) respect to su* meet+s2 7,g7 beg9n+ ) ! fiscal ye> t is #c ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 & e #c ye>s !reaft]1 aft] consultation ) p>ties pot5tially subject to ! fees & _! repres5tatives1 increase or decrease ! fees e/abli%$ "u p>agraph 7#a7 z necess>y-- 7i7 to ensure t funds deposit$ 9 ! ,fund are suffici5t to conduct ! activities id5tifi$ 9 p>agraph 7#b77;,a7 & ! full co/s ( safety assessm5ts & safety det]m9ations pursuant to subp>agraph 7,e72 & 7ii7 to acc\nt = inflation2 7,h7 adju/ fees e/abli%$ "u p>agraph 7#a7 z necess>y to v>y on acc\nt ( diff]+ circum/ances1 includ+ r$uc$ fees or waiv]s 9 appropriate circum/ances1 to r$uce ! burd5 on manufactur+ or process+1 remove b>ri]s to innovation1 or :]e ! co/s to ! ,adm9i/rator ( collect+ ! fees exce$ ! fee rev5ue anticipat$ to be collect$2 & 7,i7 if a notice submitt$ "u section #e is refus$ or subsequ5tly )drawn1 refund ! fee or a portion ( ! fee if no sub/antial "w 0 p]=m$ on ! notice4 7#d7 ,,tsca ,implem5tation ,fund 7,a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates a fund1 to be kn[n z ! ,,tsca ,implem5tation ,fund 7ref]r$ to 9 ?is subsection z ! ,fund71 consi/+ (-- 7i7 su* am\nts z are deposit$ 9 ! ,fund "u p>agraph 7#b77;,c72 & 7ii7 any int]e/ e>n$ on ! inve/m5t ( am\nts 9 ! ,fund2 & 7iii7 any proce$s f ! sale or r$emption ( inve/m5ts held 9 ! ,fund4 7,b7 ,cr$it+ & availability ( fees 7i7 ,9 g5]al ,fees au?oriz$ "u ?is section %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts1 & %all be available )\t fiscal ye> limitation4 7ii7 ,requirem5ts ,fees collect$ "u ?is section %all n-- 7,i7 be made available or obligat$ = any purpose o!r ?an to defray ! co/s ( conduct+ ! activities id5tifi$ 9 p>agraph 7#b77;,a72 7,,ii7 o!rwise be available = any purpose o!r ?an implem5tation ( ?is ,act2 & 7,,iii7 s long z am\nts 9 ! ,fund rema9 available1 be subject to re/rictions on exp5ditures applicable to ! ,f$]al gov]nm5t z a :ole4 7,c7 ,unus$ funds ,am\nts 9 ! ,fund n curr5tly ne$$ to c>ry out ?is subsection %all be-- 7i7 ma9ta9$ readily available or on deposit2 7ii7 inve/$ 9 obligations ( ! ,unit$ ,/ates or gu>ante$ by ! ,unit$ ,/ates2 or 7iii7 inve/$ 9 obligations1 p>ticipations1 or o!r in/rum5ts t are lawful inve/m5ts = fiduci>y1 tru/1 or public funds4 7,d7 ,m9imum am\nt ( appropriations ,fees may n be assess$ = a fiscal ye> "u ?is section unless ! am\nt ( appropriations = sal>ies1 contracts1 & exp5ses = ! functions 7z 9 exi/5ce 9 fiscal ye> #bjae7 ( ! ,(fice ( ,pollution ,prev5tion & ,toxics ( ! ,environm5tal ,protection ,ag5cy = ! fiscal ye> 7exclud+ ! am\nt ( any fees appropriat$ = ! fiscal ye>7 are equal to or great] ?an ! am\nt ( appropriations = cov]$ functions = fiscal ye> #bjae 7exclud+ ! am\nt ( any fees appropriat$ = ! fiscal ye>74 7#e7 ,audit+ 7,a7 ,f9ancial /atem5ts ( ag5cies ,= ! purpose ( section #ceae7;c7 ( title #ca1 ,unit$ ,/ates ,code1 ! ,fund %all be consid]$ a compon5t ( an executive ag5cy4 7,b7 ,compon5ts ,! annual audit requir$ "u sections #ceae7;b7 & #ceba ( t title ( ! f9ancial /atem5ts ( activities "u ?is subsection %all include an analysis (-- 7i7 ! fees collect$ "u p>agraph 7#a7 & disburs$2 7ii7 compliance ) ! deadl9es e/abli%$ 9 section #f ( ?is ,act2 7iii7 ! am\nts budget$1 appropriat$1 collect$ f fees1 & disburs$ to meet ! requirem5ts ( sections #d1 #d;,a1 #e1 #f1 #h1 & #ad1 includ+ ! allocation ( full "t equival5t employees to ea* su* section or activity2 & 7iv7 ! reasonabl5ess ( ! allocation ( ! ov]head associat$ ) ! conduct ( ! activities describ$ 9 p>agraph 7#b77;,a74 7,c7 ,inspector ,g5]al ,! ,inspector ,g5]al ( ! ,environm5tal ,protection ,ag5cy %all-- 7i7 conduct ! annual audit requir$ "u ?is subsection2 & 7ii7 report ! f9d+s & recomm5dations ( ! audit to ! ,adm9i/rator & to ! appropriate committees ( ,congress4 7#f7 ,t]m9ation ,! au?ority provid$ by ?is section %all t]m9ate at ! conclusion ( ! fiscal ye> t is #aj ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 unless o!rwise reau?oriz$ or modifi$ by ,congress4 2 7#b7 9 subsection 7e71 by /rik+ ,heal?1 ,education1 & ,welf>e ea* place x appe>s & ins]t+ ,heal? & ,human ,s]vices2 & 7#c7 add+ at ! end ! foll[+3 7h7 ,prior actions ,no?+ 9 ?is ,act elim9ates1 modifies1 or )draws any rule promulgat$1 ord] issu$1 or exemption e/abli%$ pursuant to ?is ,act be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 4 #bd4 ,developm5t & evaluation ( te/ me?ods & su/a9able *emi/ry ,section #bg ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbf7 is am5d$-- 7#a7 9 subsection 7a71 9 ! fir/ s5t5ce by /rik+ ,heal?1 ,education1 & ,welf>e & ins]t+ ,heal? & ,human ,s]vices2 & 7#b7 by add+ at ! end ! foll[+3 7c7 ,su/a9able ,*emi/ry ,program ,! ,presid5t %all e/abli% an int]ag5cy ,su/a9able ,*emi/ry ,program to promote & coord9ate ,f$]al su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 te*nology transf]1 comm]cialization1 education1 & tra9+ activities4 7d7 ,program activities ,! activities ( ! ,program %all be design$ to-- 7#a7 provide su/a9$ support = su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 te*nology transf]1 comm]cialization1 education1 & tra9+ ?r\gh-- 7,a7 coord9ation ( su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 & te*nology transf] conduct$ at ,f$]al laboratories & ag5cies2 & 7,b7 to ! ext5t practicable1 enc\ragem5t ( consid]ation ( su/a9able *emi/ry 91 z appropriate-- 7i7 ! conduct ( ,f$]al & ,/ate sci5ce & eng9e]+ rese>* & developm5t2 & 7ii7 ! solicitation & evaluation ( applicable proposals = sci5ce & eng9e]+ rese>* & developm5t2 7#b7 exam9e me?ods by :i* ! ,f$]al ,gov]nm5t c create inc5tives = consid]ation & use ( su/a9able *emi/ry processes & products1 includ+ innovative f9anc+ me*anisms2 7#c7 exp& ! education & tra9+ ( und]graduate & graduate /ud5ts & pr(essional sci5ti/s & eng9e]s1 includ+ ?r\gh p>tn]%ips ) indu/ry1 9 su/a9able *emi/ry sci5ce & eng9e]+2 7#d7 collect & dissem9ate in=mation on su/a9able *emi/ry rese>*1 developm5t1 & te*nology transf] includ+ in=mation on-- 7,a7 inc5tives & imp$im5ts to developm5t1 manufactur+1 & comm]cialization2 7,b7 accompli%m5ts2 7,c7 be/ practices2 & 7,d7 co/s & b5efits2 & 7#e7 support 7includ+ ?r\gh te*nical assi/ance1 p>ticipation1 f9ancial support1 or o!r =ms ( support7 economic1 legal1 & o!r appropriate social sci5ce rese>* to id5tify b>ri]s to comm]cialization & me?ods to advance comm]cialization ( su/a9able *emi/ry4 7e7 ,int]ag5cy work+ gr\p 7#a7 ,e/abli%m5t ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,presid5t1 9 consultation ) ! ,(fice ( ,sci5ce & ,te*nology ,policy1 %all e/abli% an ,int]ag5cy ,work+ ,gr\p t %all include repres5tatives f ! ,national ,sci5ce ,f\ndation1 ! ,national ,in/itute ( ,/&>ds & ,te*nology1 ! ,dep>tm5t ( ,en]gy1 ! ,environm5tal ,protection ,ag5cy1 ! ,dep>tm5t ( ,agriculture1 ! ,dep>tm5t ( ,def5se1 ! ,national ,in/itutes ( ,heal?1 & any o!r ag5cy t ! ,presid5t may designate to ov]see ! plann+1 managem5t1 & coord9ation ( ! ,program4 7#b7 ,gov]nance ,! ,director ( ! ,national ,sci5ce ,f\ndation & ! ,assi/ant ,adm9i/rator = ,rese>* & ,developm5t ( ! ,environm5tal ,protection ,ag5cy1 or _! designees1 %all s]ve z co-*airs ( ! ,int]ag5cy ,work+ ,gr\p4 7#c7 ,responsibilities ,9 ov]see+ ! plann+1 managem5t1 & coord9ation ( ! ,program1 ! ,int]ag5cy ,work+ ,gr\p %all-- 7,a7 e/abli% goals & priorities = ! ,program1 9 consultation ) ! ,advisory ,c\ncil2 7,b7 provide = int]ag5cy coord9ation1 includ+ budget coord9ation1 ( activities "u ! ,program2 7,c7 meet n lat] ?an #ij days f its e/abli%m5t & p]iodically !reaft]2 & 7,d7 e/abli% & consult ) an ,advisory ,c\ncil on a regul> basis4 7#d7 ,memb]%ip ,! ,advisory ,c\ncil memb]s %all n be employees ( ! ,f$]al ,gov]nm5t & %all include a div]se repres5tation ( kn[l$geable individuals f ! private sector 7includ+ small- & m$ium-siz$ ent]prises f across ! value *a971 academia1 ,/ate & tribal gov]nm5ts1 & nongov]nm5tal organizations & o!rs :o are 9 a position to provide exp]tise4 7f7 ,ag5cy budget reque/s 7#a7 ,9 g5]al ,ea* ,f$]al ag5cy & dep>tm5t p>ticipat+ 9 ! ,program %all1 z "p ( its annual reque/ = appropriations to ! ,(fice ( ,managem5t & ,budget1 submit a report to ! ,(fice ( ,managem5t & ,budget t-- 7,a7 id5tifies ! activities ( ! ag5cy or dep>tm5t t contribute directly to ! ,program2 & 7,b7 /ates ! portion ( ! ag5cy or dep>tm5t's reque/ = appropriations t is allocat$ to ^? activities4 7#b7 ,annual budget reque/ to congress ,! ,presid5t %all include 9 ! annual budget reque/ to ,congress a /atem5t ( ! portion ( ! annual budget reque/ = ea* ag5cy or dep>tm5t t w be allocat$ to activities und]tak5 pursuant to ! ,program4 7g7 ,report to congress 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,int]ag5cy ,work+ ,gr\p %all submit a report to ! ,committee on ,sci5ce1 ,space1 & ,te*nology & ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,environm5t & ,public ,works & ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate t %all include-- 7,a7 a summ>y ( f$]ally fund$ su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 te*nology transf]1 comm]cialization1 education1 & tra9+ activities2 7,b7 a summ>y ( ! f9ancial res\rces allocat$ to su/a9able *emi/ry initiatives2 7,c7 an analysis ( ! progress made t[>d a*iev+ ! goals & priorities ( ?is ,act1 & recomm5dations = future program activities2 7,d7 an assessm5t ( ! b5efits ( exp&+ exi/+1 f$]ally support$ regional innovation & manufactur+ hubs to include su/a9able *emi/ry & ! value ( direct+ ! creation ( #a or m d$icat$ su/a9able *emi/ry c5t]s ( excell5ce or hubs2 & 7,e7 an evaluation ( /eps tak5 & future /rategies to avoid duplication ( ef=ts1 /reaml9e int]ag5cy coord9ation1 facilitate in=mation %>+1 & spread be/ practices betwe5 p>ticipat+ ag5cies 9 ! ,program4 7#b7 ,submission to ,,gao ,! ,int]ag5cy ,work+ ,gr\p %all also submit ! report describ$ 9 p>agraph 7#a7 to ! ,gov]nm5t ,acc\ntability ,(fice = consid]ation 9 future ,congressional inquiries4 4 #be4 ,/ate programs ,section #bh ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbg7 is am5d$-- 7#a7 9 subsection 7b77#a7-- 7,a7 9 subp>agraphs 7,a7 ?r\gh 7,d71 by /rik+ ! comma at ! end ( ea* subp>agraph & ins]t+ a semicolon2 & 7,b7 9 subp>agraph 7,e71 by /rik+ 1 & & ins]t+ 2 &2 & 7#b7 by /rik+ subsections 7c7 & 7d74 #bf4 ,au?orization ( appropriations ,section #bi ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbh7 is repeal$4 #bg4 ,annual report ,section #cj ( ! ,toxic ,sub/ances ,control ,act 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 #d2 4 #bh4 ,effective date ,section #ca ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja note2 ,public ,law #id-dfi7 is am5d$-- 7#a7 by /rik+ ,except z provid$ 9 section #d7;f71 ?is & ins]t+ ! foll[+3 7a7 ,9 g5]al ,?is 2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,retroactive applicability ,no?+ 9 ?is ,act %all be int]pret$ to apply retroactively to any ,/ate1 ,f$]al1 or m>itime legal action comm5c$ prior to ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 #b4 ,f9d+s1 policy1 & int5t ,section #b7;c7 ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja7;c77 is am5d$-- 7#a7 by /rik+ ,x is ! int5t & ins]t+ ! foll[+3 7#a7 ,adm9i/ration ,x is ! int5t 2 7#b7 9 p>agraph 7#a7 7z s r$esignat$71 by ins]t+ 1 z provid$ "u ?is ,act be=e ! p]iod at ! end2 & 7#c7 by add+ at ! end ! foll[+3 7#b7 ,re=m ,?is ,act1 includ+ re=ms 9 accordance ) ! am5dm5ts made by ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act-- 7,a7 %all be adm9i/]$ 9 a mann] t-- 7i7 protects ! heal? ( *ildr51 pregnant wom51 ! eld]ly1 work]s1 consum]s1 ! g5]al public1 & ! environm5t f ! risks ( h>mful exposures to *emical sub/ances & mixtures2 & 7ii7 ensures t appropriate in=mation on *emical sub/ances & mixtures is available to public heal? (ficials & fir/ respond]s 9 ! ev5t ( an em]g5cy2 & 7,b7 %all n displace or supplant common law rights ( action or rem$ies = civil relief4 4 #c4 ,def9itions ,section #c ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjb7 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#d71 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 7#ac71 & 7#ad7 z p>agraphs 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#ab71 7#ac71 7#ag71 7#ah71 & 7#ai71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,conditions ( use ,! t]m conditions ( use means ! int5d$1 kn[n1 or reasonably =eseeable circum/ances ! ,adm9i/rator det]m9es a *emical sub/ance is manufactur$1 process$1 di/ribut$ 9 comm]ce1 us$1 or dispos$ (4 2 7#c7 by ins]t+ aft] p>agraph 7#aj7 7z s r$esignat$7 ! foll[+3 7#aa7 ,pot5tially expos$ or susceptible population ,! t]m pot5tially expos$ or susceptible population means #a or m gr\ps-- 7,a7 ( individuals )9 ! g5]al population :o may be-- 7i7 diff]5tially expos$ to *emical sub/ances "u ! conditions ( use2 or 7ii7 susceptible to great] adv]se heal? consequ5ces f *emical exposures ?an ! g5]al population2 & 7,b7 t :5 id5tifi$ by ! ,adm9i/rator may include su* gr\ps z infants1 *ildr51 pregnant wom51 work]s1 & ! eld]ly4 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 an assessm5t ( ! risk pos$ by a *emical sub/ance "u ! conditions ( use1 integrat+ haz>d1 use1 & exposure in=mation reg>d+ ! *emical sub/ance4 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 ! conditions ( use4 7#af7 ,safety /&>d ,! t]m safety /&>d means a /&>d t ensures1 )\t tak+ into consid]ation co/ or o!r nonrisk factors1 t no unreasonable risk ( injury to heal? or ! environm5t w result f exposure to a *emical sub/ance "u ! conditions ( use1 includ+ no unreasonable risk ( injury to-- 7,a7 ! g5]al population2 or 7,b7 any pot5tially expos$ or susceptible population t ! ,adm9i/rator has id5tifi$ z relevant to ! safety assessm5t & safety det]m9ation = a *emical sub/ance4 4 #d4 ,policies1 proc$ures1 & guidance ,! ,toxic ,sub/ances ,control ,act is am5d$ by ins]t+ aft] section #c 7#ae ,u4,s4,c4 #bfjb7 ! foll[+3 #c;,a4 ,policies1 proc$ures1 & guidance 7a7 ,def9ition ( guidance ,9 ?is section1 ! t]m guidance includes any significant writt5 guidance ( g5]al applicability prep>$ by ! ,adm9i/rator4 7b7 ,deadl9e ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator %all develop1 aft] provid+ public notice & an opportunity = comm5t1 any policies1 proc$ures1 & guidance ! ,adm9i/rator det]m9es to be necess>y to c>ry out sections #d1 #d;,a1 #e1 & #f1 includ+ ! policies1 proc$ures1 & guidance requir$ by ?is section4 7c7 ,use ( sci5ce 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% policies1 proc$ures1 & guidance on ! use ( sci5ce 9 mak+ decisions "u sections #d1 #d;,a1 #e1 & #f4 7#b7 ,goal ,a goal ( ! policies1 proc$ures1 & guidance describ$ 9 p>agraph 7#a7 %all be to make ! basis ( decisions cle> to ! public4 7#c7 ,requirem5ts ,! policies1 proc$ures1 & guidance issu$ "u ?is section %all describe ! mann] 9 :i* ! ,adm9i/rator %all ensure t -- 7,a7 decisions made by ! ,adm9i/rator-- 7i7 are bas$ on in=mation1 proc$ures1 measures1 me?ods1 & models employ$ 9 a mann] consi/5t ) ! be/ available sci5ce2 7ii7 take into acc\nt ! ext5t to :i*-- 7,i7 assumptions & me?ods are cle>ly & completely describ$ & docum5t$2 7,,ii7 v>iability & unc]ta9ty are evaluat$ & *>act]iz$2 & 7,,iii7 ! in=mation has be5 subject to indep5d5t v]ification & pe] review2 & 7iii7 are bas$ on ! weight ( ! sci5tific evid5ce1 by :i* ! ,adm9i/rator consid]s all in=mation 9 a sy/ematic & integrative framework to consid] ! relevance ( diff]5t in=mation2 7,b7 to ! ext5t practicable & if appropriate1 ! use ( pe] review1 /&>diz$ te/ design & me?ods1 consi/5t data evaluation proc$ures1 & good laboratory practices w be enc\rag$2 7,c7 a cle> description ( ea* individual & entity t fund$ ! g5]ation or assessm5t ( in=mation1 & ! degree ( control ^? individuals & entities _h ov] ! g5]ation1 assessm5t1 & dissem9ation ( in=mation 7includ+ control ov] ! design ( ! "w & ! publication ( in=mation7 is made available2 & 7,d7 if appropriate1 ! recomm5dations 9 reports ( ! ,national ,academy ( ,sci5ces t provide advice reg>d+ assess+ ! haz>ds1 exposures1 & risks ( *emical sub/ances are consid]$4 7d7 ,exi/+ ,,epa policies1 proc$ures1 & guidance ,! policies1 proc$ures1 & guidance describ$ 9 subsection 7b7 %all incorporate1 z appropriate1 exi/+ relevant haz>d1 exposure1 & risk assessm5t guidel9es & me?odologies1 data evaluation & quality crit]ia1 te/+ me?odologies1 & o!r relevant guidel9es & policies ( ! ,environm5tal ,protection ,ag5cy4 7e7 ,review ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 & n less frequ5tly ?an once e #e ye>s !reaft]1 ! ,adm9i/rator %all-- 7#a7 review ! adequacy ( any policies1 proc$ures1 & guidance develop$ "u ?is section1 includ+ animal1 nonanimal1 & epidemiological te/ me?ods & proc$ures = assess+ & det]m9+ risk "u ?is ,act2 & 7#b7 aft] provid+ public notice & an opportunity = comm5t1 revise ! policies1 proc$ures1 & guidance if necess>y to reflect new sci5tific developm5ts or und]/&+s4 7f7 ,s\rces ( in=mation ,9 c>ry+ out sections #d1 #d;,a1 #e1 & #f1 ! ,adm9i/rator %all take into consid]ation in=mation relat+ to a *emical sub/ance1 includ+ haz>d & exposure in=mation1 "u ! conditions ( use t is reasonably available to ! ,adm9i/rator1 includ+ in=mation t is-- 7#a7 submitt$ to ! ,adm9i/rator pursuant to any rule1 cons5t agreem5t1 ord]1 or o!r requirem5t ( ?is ,act1 or on a volunt>y basis1 includ+ pursuant to any reque/ made "u ?is ,act1 by-- 7,a7 manufactur]s or processors ( a sub/ance2 7,b7 ! public2 7,c7 o!r ,f$]al dep>tm5ts or ag5cies2 or 7,d7 ! ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? or ! environm5t2 7#b7 submitt$ to a gov]nm5tal entity 9 any jurisdiction pursuant to a gov]nm5tal requirem5t relat+ to ! protection ( heal? or ! environm5t2 or 7#c7 id5tifi$ ?r\gh an active se>* by ! ,adm9i/rator ( in=mation s\rces t are publicly available or o!rwise accessible by ! ,adm9i/rator4 7g7 ,te/+ ( *emical sub/ances & mixtures 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% policies & proc$ures = ! te/+ ( *emical sub/ances or mixtures "u section #d4 7#b7 ,goal ,a goal ( ! policies & proc$ures e/abli%$ "u p>agraph 7#a7 %all be to make ! basis ( decisions cle> to ! public4 7#c7 ,cont5ts ,! policies & proc$ures e/abli%$ "u p>agraph 7#a7 %all-- 7,a7 address h[ & :5 ! exposure level or exposure pot5tial ( a *emical sub/ance w\ld factor into decisions to require new te/+1 subject to ! condition t ! ,adm9i/rator %all n int]pret ! lack ( exposure in=mation z a lack ( exposure or exposure pot5tial2 7,b7 describe ! mann] 9 :i* ! ,adm9i/rator w det]m9e t additional in=mation is necess>y to c>ry out ?is ,act1 includ+ in=mation relat+ to pot5tially expos$ or susceptible populations2 7,c7 require ! ,adm9i/rator to consult ) ! ,director ( ! ,national ,in/itute = ,occupational ,safety & ,heal? prior to prescrib+ epidemiologic /udies ( employees2 & 7,d7 require t prior to mak+ a reque/ or adopt+ a requirem5t = te/+ us+ v]tebrate animals1 ! ,adm9i/rator %all take into consid]ation1 z appropriate & to ! ext5t practicable1 reasonably available-- 7i7 toxicity in=mation2 7ii7 computational toxicology & bio9=matics2 7iii7 high-?r\ghput scre5+ me?ods & ! pr$iction models ( ^? me?ods2 & 7iv7 sci5tifically reliable & relevant alt]natives to te/s on animals t w\ld provide equival5t in=mation4 7h7 ,safety assessm5ts & safety det]m9ations 7#a7 ,s*$ule 7,a7 ,9 g5]al ,! ,adm9i/rator %all in=m ! public reg>d+ ! s*$ule = ! completion ( ea* safety assessm5t & safety det]m9ation z soon z practicable aft] designation z a high-priority sub/ance pursuant to section #d;,a4 7,b7 ,diff]+ times ,! ,adm9i/rator may allot diff]5t times = diff]5t *emical sub/ances 9 ! s*$ules "u ?is p>agraph1 subject to ! condition t all s*$ules %all comply ) ! deadl9es e/abli%$ "u section #f4 7,c7 ,annual plan ,at ! beg9n+ ( ea* cal5d> ye>1 ! ,adm9i/rator %all id5tify ! sub/ances subject to safety assessm5ts & safety det]m9ations to be complet$ t ye>4 7#b7 ,policies & proc$ures = safety assessm5ts & safety det]m9ations 7,a7 ,9 g5]al ,! ,adm9i/rator %all e/abli%1 by rule1 policies & proc$ures reg>d+ ! mann] 9 :i* ! ,adm9i/rator %all c>ry out section #f4 7,b7 ,goal ,a goal ( ! policies & proc$ures "u ?is p>agraph %all be to make ! basis ( decisions ( ! ,adm9i/rator cle> to ! public4 7,c7 ,m9imum requirem5ts ,at a m9imum1 ! policies & proc$ures "u ?is p>agraph %all-- 7i7 describe-- 7,i7 ! mann] 9 :i* ! ,adm9i/rator w id5tify in=mational ne$s & seek t in=mation f ! public2 7,,ii7 ! in=mation 7includ+ draft safety assessm5ts7 t may be submitt$ by int]e/$ individuals or entities1 includ+ ,/ates2 & 7,,iii7 ! crit]ia by :i* t in=mation w be evaluat$2 7ii7 require ! ,adm9i/rator-- 7,i7 7aa7 to def9e ! scope ( ! safety assessm5t & safety det]m9ation to be conduct$ "u section #f1 includ+ ! haz>ds1 exposures1 conditions ( use1 & pot5tially expos$ & susceptible populations t ! ,adm9i/rator expects to consid] 9 a safety assessm5t2 7bb7 to expla9 ! basis = ! scope ( ! safety assessm5t & safety det]m9ation2 & 7cc7 to accept comm5ts reg>d+ ! scope ( ! safety assessm5t & safety det]m9ation2 & 7,,ii7 7aa7 to id5tify ! items describ$ 9 subclause 7,i7 t ! ,adm9i/rator has consid]$ 9 ! f9al safety assessm5t2 & 7bb7 to expla9 ! basis = ! consid]ation ( ^? items2 7iii7 describe ! mann] 9 :i* aggregate exposures1 or significant subsets ( exposures1 to a *emical sub/ance "u ! conditions ( use w be consid]$1 & expla9 ! basis = t consid]ation 9 ! f9al safety assessm5t2 7iv7 require t ea* safety assessm5t & safety det]m9ation %all include-- 7,i7 a description ( ! weight ( ! sci5tific evid5ce ( risk2 & 7,,ii7 a summ>y ( ! in=mation reg>d+ ! impact on heal? & ! environm5t ( ! *emical sub/ance t 0 us$ to make ! assessm5t or det]m9ation1 includ+1 z available1 me*ani/ic1 animal toxicity1 & epidemiology /udies2 7v7 e/abli% a timely & transp>5t process = evaluat+ :e!r new in=mation submitt$ or obta9$ aft] ! date ( a f9al safety assessm5t or safety det]m9ation w>rants reconsid]ation ( ! safety assessm5t or safety det]m9ation2 & 7vi7 :5 relevant in=mation is provid$ or o!rwise made available to ! ,adm9i/rator1 %all consid] ! ext5t ( ,f$]al regulation "u o!r ,f$]al laws4 7,d7 ,guidance 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator %all develop guidance to assi/ int]e/$ p]sons 9 develop+ _! own draft safety assessm5ts & o!r in=mation = submission to ! ,adm9i/rator1 :i* may be consid]$ at ! discretion ( ! ,adm9i/rator4 7ii7 ,requirem5t ,! guidance %all1 at a m9imum1 address ! quality ( ! in=mation submitt$ & ! process to be foll[$ 9 develop+ a draft safety assessm5t = consid]ation by ! ,adm9i/rator4 7i7 ,publicly available in=mation ,subject to section #ad1 ! ,adm9i/rator %all-- 7#a7 make publicly available a nonte*nical summ>y1 & ! f9al v]sion1 ( ea* safety assessm5t & safety det]m9ation2 7#b7 provide public notice & an opportunity = comm5t on ea* propos$ safety assessm5t & safety det]m9ation2 & 7#c7 make public 9 a f9al safety assessm5t & safety det]m9ation-- 7,a7 ! li/ ( /udies consid]$ by ! ,adm9i/rator 9 c>ry+ out ! safety assessm5t or safety det]m9ation2 & 7,b7 ! li/ ( policies1 proc$ures1 & guidance t 7 foll[$ 9 c>ry+ out ! safety assessm5t or safety det]m9ation4 7j7 ,consultation ) ,sci5ce ,advisory ,committee on ,*emicals 7#a7 ,e/abli%m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,adm9i/rator %all e/abli% an advisory committee1 to be kn[n z ! ,sci5ce ,advisory ,committee on ,*emicals 7ref]r$ to 9 ?is subsection z ! ,committee74 7#b7 ,purpose ,! purpose ( ! ,committee %all be to provide indep5d5t advice & exp]t consultation1 on ! reque/ ( ! ,adm9i/rator1 ) respect to ! sci5tific & te*nical aspects ( issues relat+ to ! implem5tation ( ?is title4 7#c7 ,composition ,! ,committee %all be compos$ ( repres5tatives ( su* sci5ce1 gov]nm5t1 labor1 public heal?1 public int]e/1 animal protection1 indu/ry1 & o!r gr\ps z ! ,adm9i/rator det]m9es to be advisable1 includ+1 at a m9imum1 repres5tatives t h specific sci5tific exp]tise 9 ! relation%ip ( *emical exposures to wom51 *ildr51 & o!r pot5tially expos$ or susceptible populations4 7#d7 ,s*$ule ,! ,adm9i/rator %all conv5e ! ,committee 9 accordance ) su* s*$ule z ! ,adm9i/rator det]m9es to be appropriate1 b n less frequ5tly ?an once e #b ye>s4 7#e7 ,relation%ip to o!r law ,all proce$+s & meet+s ( ! ,committee %all be subject to ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 4 #e4 ,te/+ ( *emical sub/ances or mixtures 7a7 ,9 g5]al ,section #d ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjc7 is am5d$-- 7#a7 by /rik+ subsections 7a71 7b71 7c71 7d71 & 7g72 7#b7 by r$esignat+ subsections 7e7 & 7f7 z subsections 7f7 & 7g71 respectively2 7#c7 9 subsection 7f7 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#a7-- 7i7 9 subp>agraph 7,a77v71 by ins]t+ 1 )\t tak+ into acc\nt co/ or o!r nonrisk factors aft] ! environm5t2 & 7ii7 9 subp>agraph 7,b71 9 ! la/ s5t5ce1 by /rik+ rulemak+2 7#d7 9 subsection 7g7 7z s r$esignat$7-- 7,a7 9 ! fir/ s5t5ce-- 7i7 by /rik+ f canc]1 g5e mutations1 or bir? defects2 & 7ii7 by ins]t+ 1 )\t tak+ into acc\nt co/ or o!r nonrisk factors be=e ! p]iod at ! end2 & 7,b7 by /rik+ ! la/ s5t5ce2 & 7#e7 by ins]t+ be=e subsection 7f7 7z s r$esignat$7 ! foll[+3 7a7 ,developm5t ( new in=mation on *emical sub/ances & mixtures 7#a7 ,9 g5]al ,! ,adm9i/rator may require ! developm5t ( new in=mation relat+ to a *emical sub/ance or mixture 9 accordance ) ?is section if ! ,adm9i/rator det]m9es t ! in=mation is necess>y-- 7,a7 to review a notice "u section #e7;d7 or to p]=m a safety assessm5t or safety det]m9ation "u section #f2 7,b7 to implem5t a requirem5t impos$ 9 a cons5t agreem5t or ord] issu$ "u section #e7;d77#d7 or "u a rule promulgat$ "u section #f7;d77#c72 7,c7 pursuant to section #ab7;a77#d72 or 7,d7 at ! reque/ ( ! implem5t+ au?ority "u ano!r ,f$]al law1 to meet ! regulatory te/+ ne$s ( t au?ority4 7#b7 ,limit$ te/+ = prioritization purposes 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ! ,adm9i/rator may require ! developm5t ( new in=mation = ! purposes ( section #d;,a4 7,b7 ,prohibition ,te/+ requir$ "u subp>agraph 7,a7 %all n be requir$ = ! purpose ( e/abli%+ or implem5t+ a m9imum in=mation requirem5t4 7,c7 ,limitation ,! ,adm9i/rator may require ! developm5t ( new in=mation pursuant to subp>agraph 7,a7 only if ! ,adm9i/rator det]m9es t additional in=mation is necess>y to e/abli% ! priority ( a *emical sub/ance4 7#c7 ,=m ,! ,adm9i/rator may require ! developm5t ( in=mation describ$ 9 p>agraph 7#a7 or 7#b7 by-- 7,a7 promulgat+ a rule2 7,b7 ent]+ into a te/+ cons5t agreem5t2 or 7,c7 issu+ an ord]4 7#d7 ,cont5ts 7,a7 ,9 g5]al ,a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u ?is subsection %all include-- 7i7 id5tification ( ! *emical sub/ance or mixture = :i* te/+ is requir$2 7ii7 id5tification ( ! p]sons requir$ to conduct ! te/+2 7iii7 te/ protocols & me?odologies = ! developm5t ( in=mation = ! *emical sub/ance or mixture1 includ+ specific ref]5ce to any reliable nonanimal te/ proc$ures2 & 7iv7 specification ( ! p]iod )9 :i* individuals & entities requir$ to conduct ! te/+ %all submit to ! ,adm9i/rator ! in=mation develop$ 9 accordance ) ! proc$ures describ$ 9 clause 7iii74 7,b7 ,consid]ations ,9 det]m9+ ! proc$ures & p]iod to be requir$ "u subp>agraph 7,a71 ! ,adm9i/rator %all take into consid]ation-- 7i7 ! relative co/s ( ! v>i\s te/ protocols & me?odologies t may be requir$2 & 7ii7 ! reasonably =eseeable availability ( facilities & p]sonnel requir$ to p]=m ! te/+4 7b7 ,/atem5t ( ne$ 7#a7 ,9 g5]al ,9 promulgat+ a rule1 ent]+ into a te/+ cons5t agreem5t1 or issu+ an ord] = ! developm5t ( additional in=mation 7includ+ in=mation on exposure or exposure pot5tial7 pursuant to ?is section1 ! ,adm9i/rator %all-- 7,a7 id5tify ! ne$ int5d$ to be met by ! rule1 agreem5t1 or ord]2 7,b7 expla9 :y in=mation reasonably available to ! ,adm9i/rator at t "t is inadequate to meet t ne$1 includ+ a ref]5ce1 z appropriate1 to ! in=mation id5tifi$ 9 p>agraph 7#b77;,b72 & 7,c7 expla9 ! basis = any decision t requires ! use ( v]tebrate animals4 7#b7 ,explanation 9 case ( ord] 7,a7 ,9 g5]al ,if ! ,adm9i/rator issues an ord] "u ?is section1 ! ,adm9i/rator %all issue a /atem5t provid+ a ju/ification = :y issuance ( an ord] is w>rant$ 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 description (-- 7i7 in=mation t is readily accessible to ! ,adm9i/rator1 includ+ in=mation submitt$ "u any o!r provision ( law2 7ii7 ! ext5t to :i* ! ,adm9i/rator has obta9$ or attempt$ to obta9 ! in=mation ?r\gh volunt>y submissions2 & 7iii7 any in=mation reli$ on 9 safety assessm5ts = o!r *emical sub/ances relevant to ! *emical sub/ances t w\ld be ! subject ( ! ord]4 7c7 ,r$uction ( te/+ on v]tebrates 7#a7 ,9 g5]al ,! ,adm9i/rator %all m9imize1 to ! ext5t practicable1 ! use ( v]tebrate animals 9 te/+ ( *emical sub/ances or mixtures1 by-- 7,a7 enc\rag+ & facilitat+-- 7i7 ! use ( integrat$ & ti]$ te/+ & assessm5t /rategies2 7ii7 ! use ( be/ available sci5ce 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+ 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 in=mation on o!r *emical sub/ances 9 ! category2 7v7 ! =mation ( indu/ry consortia to jo9tly conduct te/+ to avoid unnecess>y duplication ( te/s2 & 7vi7 ! submission ( in=mation f-- 7,i7 animal-bas$ /udies2 & 7,,ii7 em]g+ me?ods & models2 & 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 bas$ on v]tebrate animals1 ! ,adm9i/rator %all-- 7,a7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 develop a /rategic plan to promote ! developm5t & implem5tation ( alt]native te/ me?ods & te/+ /rategies to g5]ate in=mation "u ?is title t c r$uce1 ref9e1 or replace ! use ( v]tebrate 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 z practicable1 ensure t ! /rategic plan develop$ "u subp>agraph 7,a7 is reflect$ 9 ! developm5t ( requirem5ts = te/+ "u ?is section2 7,c7 id5tify 9 ! /rategic plan develop$ "u subp>agraph 7,a7 p>ticul> alt]native te/ me?ods or te/+ /rategies t d n require new v]tebrate animal te/+ & are sci5tifically reliable1 relevant1 & capable ( provid+ in=mation ( equival5t sci5tific reliability & quality to t :i* w\ld be obta9$ f v]tebrate animal te/+2 7,d7 provide an opportunity = public notice & comm5t on ! cont5ts ( ! plan develop$ "u subp>agraph 7,a71 includ+ ! crit]ia = consid]+ sci5tific reliability1 relevance1 & equival5t in=mation & ! te/ me?ods & /rategies id5tifi$ 9 subp>agraph 7,c72 7,e7 beg9n+ on ! date t is #e ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act & e #e ye>s !reaft]1 submit to ,congress a report t describes ! progress made 9 implem5t+ ?is subsection & goals = future alt]native te/ me?ods implem5tation2 7,f7 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 ( v]tebrate animals 9 any te/+ "u ?is title2 & 7,g7 id5tify syn]gies ) ! relat$ in=mation requirem5ts ( o!r jurisdictions to m9imize ! pot5tial = additional or duplicative te/+4 7#c7 ,crit]ia = adapt+ or waiv+ animal te/+ requirem5ts ,on reque/ f a manufactur] or processor t is requir$ to conduct te/+ ( a *emical sub/ance or mixture on v]tebrate animals "u ?is section1 ! ,adm9i/rator may adapt or waive ! requirem5t1 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 z a result ( #a or m physical or *emical prop]ties ( ! *emical sub/ance or mixture or o!r toxicok9etic consid]ations-- 7i7 ! sub/ance _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 v]tebrate 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 7#d7 ,volunt>y te/+ 7,a7 ,9 g5]al ,any p]son develop+ in=mation = submission "u ?is title on a volunt>y basis & n pursuant to any reque/ or requirem5t by ! ,adm9i/rator %all fir/ attempt to develop ! in=mation by means ( an alt]native or nonanimal te/ me?od or te/+ /rategy t ! ,adm9i/rator has det]m9$ "u p>agraph 7#b77;,c7 to be sci5tifically reliable1 relevant1 & capable ( provid+ equival5t in=mation1 be=e conduct+ new animal te/+4 7,b7 ,effect ( p>agraph ,no?+ 9 ?is p>agraph-- 7i7 requires ! ,adm9i/rator to review ! basis on :i* ! p]son is conduct+ te/+ describ$ 9 subp>agraph 7,a72 7ii7 prohibits ! use ( o!r te/ me?ods or te/+ /rategies by any p]son = purposes o!r ?an develop+ in=mation = submission "u ?is title on a volunt>y basis2 or 7iii7 prohibits ! use ( o!r te/ me?ods or te/+ /rategies by any p]son1 subsequ5t to ! attempt to develop in=mation us+ ! te/ me?ods & te/+ /rategies id5tifi$ by ! ,adm9i/rator "u p>agraph 7#b77;,c74 7d7 ,te/+ requirem5ts 7#a7 ,9 g5]al ,! ,adm9i/rator may require ! developm5t ( in=mation by-- 7,a7 manufactur]s & processors ( ! *emical sub/ance or mixture2 & 7,b7 subject to p>agraph 7#c71 p]sons t beg9 to manufacture or process ! *emical sub/ance or mixture-- 7i7 aft] ! effective date ( ! rule1 te/+ cons5t agreem5t1 or ord]2 b 7ii7 be=e ! p]iod end+ on ! lat] (-- 7,i7 #e ye>s aft] ! date ref]r$ to 9 clause 7i72 or 7,,ii7 ! la/ day ( ! p]iod t beg9s on ! date ref]r$ to 9 clause 7i7 & t is equal to ! p]iod t ! ,adm9i/rator det]m9es 0 necess>y to develop ! in=mation4 7#b7 ,designation ,! ,adm9i/rator may p]mit #b or m p]sons id5tifi$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 to designate #a ( ! p]sons or a qualifi$ ?ird p>ty-- 7,a7 to develop ! in=mation2 & 7,b7 to submit ! in=mation on behalf ( ! p]sons mak+ ! designation4 7#c7 ,exemptions 7,a7 ,9 g5]al ,a p]son o!rwise subject to a rule1 te/+ cons5t agreem5t1 or ord] "u ?is section may submit to ! ,adm9i/rator an application = an exemption on ! basis t ! in=mation is be+ develop$ by a p]son designat$ "u p>agraph 7#b74 7,b7 ,fair & equitable reimbursem5t to designee 7i7 ,9 g5]al ,if ! ,adm9i/rator accepts an application submitt$ "u subp>agraph 7,a71 ! ,adm9i/rator %all direct ! applicant to provide to ! p]son designat$ "u p>agraph 7#b7 fair & equitable reimbursem5t1 z agre$ to betwe5 ! applicant & ! designee4 7ii7 ,arbitration ,if ! applicant & a p]son designat$ "u p>agraph 7#b7 _c rea* agreem5t on ! am\nt ( fair & equitable reimbursem5t1 ! am\nt %all be det]m9$ by arbitration4 7,c7 ,t]m9ation ,if1 aft] grant+ an exemption "u ?is p>agraph1 ! ,adm9i/rator det]m9es t no p]son designat$ "u p>agraph 7#b7 has compli$ ) ! rule1 te/+ cons5t agreem5t1 or ord]1 ! ,adm9i/rator %all-- 7i7 by ord]1 t]m9ate ! exemption2 & 7ii7 notify 9 writ+ ea* p]son t receiv$ an exemption ( ! requirem5ts ) respect to :i* ! exemption 0 grant$4 7#d7 ,ti]$ te/+ 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,d71 ! ,adm9i/rator %all employ a ti]$ scre5+ & te/+ process1 "u :i* ! results ( scre5+-level te/s or assessm5ts ( available in=mation in=m ! decision z to :e!r #a or m additional te/s are necess>y4 7,b7 ,scre5+-level te/s 7i7 ,9 g5]al ,! scre5+-level te/s requir$ = a *emical sub/ance or mixture may include te/s = haz>d 7:i* may include 9 silico1 9 vitro1 & 9 vivo te/s71 environm5tal & biological fate & transport1 & measurem5ts or model+ ( exposure or exposure pot5tial1 z appropriate4 7ii7 ,use ,scre5+-level te/s %all be us$-- 7,i7 to scre5 *emical sub/ances or mixtures = pot5tial adv]se effects2 & 7,,ii7 to in=m a decision ( ! ,adm9i/rator reg>d+ :e!r m complex or t>get$ additional te/+ is necess>y4 7,c7 ,additional te/+ ,if ! ,adm9i/rator det]m9es "u subp>agraph 7,b7 t additional te/+ is necess>y to provide m def9itive in=mation = safety assessm5ts or safety det]m9ations1 ! ,adm9i/rator may require m advanc$ te/s = pot5tial heal? or environm5tal effects or exposure pot5tial4 7,d7 ,advanc$ te/+ )\t scre5+ ,! ,adm9i/rator may require m advanc$ te/+ )\t conduct+ scre5+-level te/+ :5 o!r in=mation available to ! ,adm9i/rator ju/ifies ! advanc$ te/+1 pursuant to guidance develop$ by ! ,adm9i/rator "u ?is section4 7e7 ,transp>5cy ,subject to section #ad1 ! ,adm9i/rator %all make available to ! public all te/+ cons5t agreem5ts & ord]s & all in=mation submitt$ "u ?is section4 4 7b7 ,con=m+ am5dm5t ,section #ajd7;i77#e77;,a7 ( ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act ( #aihj 7#db ,u4,s4,c4 #ifjd7;i77#e77;,a77 is am5d$ 9 ! ?ird s5t5ce by /rik+ section #d7;e7 & ins]t+ section #d7;f74 #f4 ,prioritization scre5+ ,! ,toxic ,sub/ances ,control ,act is am5d$ by ins]t+ aft] section #d 7#ae ,u4,s4,c4 #bfjc7 ! foll[+3 #d;,a4 ,prioritization scre5+ 7a7 ,prioritization scre5+ process & li/ ( sub/ances 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,adm9i/rator %all e/abli%1 by rule1 a risk-bas$ scre5+ process & explicit crit]ia = id5tify+ exi/+ *emical sub/ances t are-- 7,a7 a high priority = a safety assessm5t & safety det]m9ation "u section #f 7ref]r$ to 9 ?is ,act z high-priority sub/ances72 & 7,b7 a l[ priority = a safety assessm5t & safety det]m9ation 7ref]r$ to 9 ?is ,act z l[-priority sub/ances74 7#b7 ,initial li/ ( high- & l[-priority sub/ances 7,a7 ,9 g5]al ,be=e ! date ( promulgation ( ! rule "u p>agraph 7#a7 & n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is section1 ! ,adm9i/rator-- 7i7 %all take into consid]ation & publi% an initial li/ ( high-priority sub/ances & l[-priority sub/ances2 & 7ii7 pursuant to section #f7;b71 may initiate or cont9ue safety assessm5ts & safety det]m9ations = ^? high-priority sub/ances4 7,b7 ,requirem5ts 7i7 ,9 g5]al ,! initial li/ ( *emical sub/ances %all conta9 at lea/ #aj high-priority sub/ances1 at lea/ #e ( :i* are drawn f ! li/ ( *emical sub/ances id5tifi$ by ! ,adm9i/rator 9 ! ,octob] #bjad ,,tsca ,"w ,plan & subsequ5t updates1 & at lea/ #aj l[-priority sub/ances4 7ii7 ,subsequ5tly id5tifi$ sub/ances ,ins(> z possible1 at lea/ #ej p]c5t ( all sub/ances subsequ5tly id5tifi$ by ! ,adm9i/rator z high-priority sub/ances %all be drawn f ! li/ ( *emical sub/ances id5tifi$ by ! ,adm9i/rator 9 ! ,octob] #bjad ,,tsca ,"w ,plan & subsequ5t updates1 until all ,"w ,plan *emicals h be5 designat$ "u ?is subsection4 7iii7 ,p]si/5ce & bioaccumulation ,9 develop+ ! initial li/ & 9 id5tify+ additional high-priority sub/ances1 ! ,adm9i/rator %all give pref]5ce to *emical sub/ances scor$ z high = p]si/5ce & bioaccumulation 9 ! ,octob] #bjad ,,tsca ,"w ,plan & subsequ5t updates4 7,c7 ,additional *emical reviews ,! ,adm9i/rator %all1 z soon z practicable & n lat] ?an-- 7i7 #c ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 add additional high-priority sub/ances suffici5t to ensure t at lea/ a total ( #bj high-priority sub/ances h und]gone or are und]go+ ! process e/abli%$ 9 section #f7;a71 & additional l[-priority sub/ances suffici5t to ensure t at lea/ a total ( #bj l[-priority sub/ances h be5 designat$2 & 7ii7 #e ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 add additional high-priority sub/ances suffici5t to ensure t at lea/ a total ( #be high-priority sub/ances h und]gone or are und]go+ ! process e/abli%$ 9 section #f7;a71 & additional l[-priority sub/ances suffici5t to ensure t at lea/ a total ( #be l[-priority sub/ances h be5 designat$4 7#c7 ,implem5tation 7,a7 ,consid]ation ( active & inactive sub/ances 7i7 ,active sub/ances ,9 c>ry+ out p>agraph 7#a71 ! ,adm9i/rator %all take into consid]ation active sub/ances1 z det]m9$ "u section #h1 :i* may include *emical sub/ances on ! int]im li/ ( active sub/ances e/abli%$ "u t section4 7ii7 ,inactive sub/ances ,9 c>ry+ out p>agraph 7#a71 ! ,adm9i/rator may take into consid]ation inactive sub/ances1 z det]m9$ "u section #h1 t ! ,adm9i/rator det]m9es-- 7,i7 7aa7 h n be5 subject to a regulatory or o!r en=ceable action by ! ,adm9i/rator to ban or phase out ! sub/ances2 & 7bb7 h ! pot5tial = high haz>d & widespread exposure2 or 7,,ii7 7aa7 h be5 subject to a regulatory or o!r en=ceable action by ! ,adm9i/rator to ban or phase out ! sub/ances2 & 7bb7 ) respect to :i* !re exi/s ! pot5tial = residual high haz>ds or widespread exposures n o!rwise address$ by ! regulatory or o!r action4 7iii7 ,repopulation 7,i7 ,9 g5]al ,on ! completion ( a safety det]m9ation "u section #f = a *emical sub/ance1 ! ,adm9i/rator %all remove ! *emical sub/ance f ! li/ ( high-priority sub/ances e/abli%$ "u ?is subsection4 7,,ii7 ,additions ,! ,adm9i/rator %all add at lea/ #a *emical sub/ance to ! li/ ( high-priority sub/ances = ea* *emical sub/ance remov$ f ! li/ ( high-priority sub/ances e/abli%$ "u ?is subsection1 until a safety assessm5t & safety det]m9ation is complet$ = all high-priority sub/ances4 7,,iii7 ,l[-priority sub/ances ,if a l[-priority sub/ance is subsequ5tly designat$ z a high-priority sub/ance1 ! ,adm9i/rator %all remove t sub/ance f ! li/ ( l[-priority sub/ances4 7,b7 ,timely completion ( prioritization scre5+ process 7i7 ,9 g5]al ,! ,adm9i/rator %all-- 7,i7 except z provid$ "u p>agraph 7#b71 n lat] ?an #ahj days aft] ! effective date ( ! f9al rule "u p>agraph 7#a71 beg9 ! prioritization scre5+ process2 & 7,,ii7 make e ef=t to complete ! designation ( all active sub/ances z high-priority sub/ances or l[-priority sub/ances 9 a timely mann]4 7ii7 ,decisions on sub/ances subject to te/+ = prioritization purposes ,n lat] ?an #ij days aft] ! date ( receipt ( in=mation reg>d+ a *emical sub/ance comply+ ) a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u section #d7;a77#b71 ! ,adm9i/rator %all designate ! *emical sub/ance z a high-priority sub/ance or l[-priority sub/ance4 7iii7 ,consid]ation 7,i7 ,9 g5]al ,! ,adm9i/rator %all scre5 sub/ances & designate high-priority sub/ances tak+ into consid]ation ! ability ( ! ,adm9i/rator to s*$ule & complete safety assessm5ts & safety det]m9ations "u section #f 9 a timely mann]4 7,,ii7 ,annual goal ,! ,adm9i/rator %all publi% an annual goal = ! numb] ( *emical sub/ances to be subject to ! prioritization scre5+ process4 7,c7 ,scre5+ ( categories ( sub/ances ,! ,adm9i/rator may scre5 categories ( *emical sub/ances to ensure an effici5t prioritization scre5+ process to all[ = timely & adequate designations ( high-priority sub/ances & l[-priority sub/ances & safety assessm5ts & safety det]m9ations = high-priority sub/ances4 7,d7 ,publication ( li/ ( *emical sub/ances ,! ,adm9i/rator %all keep curr5t & publi% a li/ ( *emical sub/ances t-- 7i7 are be+ consid]$ 9 ! prioritization scre5+ process & ! /atus ( ! *emical sub/ances 9 ! prioritization process1 includ+ ^? *emical sub/ances = :i* prioritization decisions h be5 def]r$2 & 7ii7 are designat$ z high-priority sub/ances or l[-priority sub/ances1 includ+ ! bases = su* designations4 7#d7 ,crit]ia ,! crit]ia describ$ 9 p>agraph 7#a7 %all acc\nt =-- 7,a7 ! recomm5dation ( ! ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? or ! environm5t f *emical sub/ances appropriate = prioritization scre5+2 7,b7 ! haz>d & exposure pot5tial ( ! *emical sub/ance 7or category ( sub/ances71 includ+ p]si/5ce1 bioaccumulation1 & specific sci5tific classifications & designations by au?oritative gov]nm5tal entities2 7,c7 ! conditions ( use or significant *anges 9 ! conditions ( use ( ! *emical sub/ance2 7,d7 evid5ce & indicators ( exposure pot5tial to humans or ! environm5t f ! *emical sub/ance1 includ+ pot5tially expos$ or susceptible populations2 7,e7 ! volume ( a *emical sub/ance manufactur$ or process$2 7,f7 :e!r ! volume ( a *emical sub/ance z report$ "u a rule promulgat$ pursuant to section #h7;a7 has significantly increas$ or decreas$ dur+ ! p]iod beg9n+ on ! date ( a previ\s report or ! date on :i* a notice has be5 submitt$ "u section #e7;b7 = t *emical sub/ance2 7,g7 ! availability ( in=mation reg>d+ pot5tial haz>ds & exposures requir$ = conduct+ a safety assessm5t or safety det]m9ation1 ) limit$ availability ( relevant in=mation to be a suffici5t basis = designat+ a *emical sub/ance z a high-priority sub/ance1 subject to ! condition t limit$ availability %all n require designation z a high-priority sub/ance2 & 7,h7 ! 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 high-priority or a l[-priority sub/ance4 7b7 ,prioritization scre5+ process & decisions 7#a7 ,9 g5]al ,! prioritization scre5+ process develop$ "u subsection 7a7 %all include a requirem5t t ! ,adm9i/rator %all-- 7,a7 id5tify ! *emical sub/ances be+ consid]$ = prioritization2 7,b7 reque/ int]e/$ p]sons to supply in=mation reg>d+ ! *emical sub/ances be+ consid]$2 7,c7 apply ! crit]ia id5tifi$ 9 subsection 7a77#d72 & 7,d7 subject to p>agraph 7#e7 & us+ ! in=mation available to ! ,adm9i/rator at ! "t ( ! decision1 id5tify a *emical sub/ance z a high-priority sub/ance or a l[-priority sub/ance4 7#b7 ,integration ( in=mation ,! prioritization scre5+ decision reg>d+ a *emical sub/ance %all integrate any haz>d & exposure in=mation relat+ to ! *emical sub/ance t is available to ! ,adm9i/rator4 7#c7 ,id5tification ( high-priority sub/ances ,! ,adm9i/rator-- 7,a7 %all id5tify z a high-priority sub/ance a *emical sub/ance t1 relative to o!r active *emical sub/ances1 ! ,adm9i/rator det]m9es has ! pot5tial = significant haz>d & significant exposure2 7,b7 may id5tify z a high-priority sub/ance a *emical sub/ance t1 relative to o!r active *emical sub/ances1 ! ,adm9i/rator det]m9es has ! pot5tial = significant haz>d or significant exposure2 & 7,c7 may id5tify z a high-priority sub/ance an inactive sub/ance1 z det]m9$ "u subsection 7a77#c77;,a77ii7 & section #h7;b71 t ! ,adm9i/rator det]m9es w>rants a safety assessm5t & safety det]m9ation "u section #f4 7#d7 ,id5tification ( l[-priority sub/ances ,! ,adm9i/rator %all id5tify z a l[-priority sub/ance a *emical sub/ance t ! ,adm9i/rator concludes has in=mation suffici5t to e/abli% t ! *emical sub/ance is likely to meet ! safety /&>d4 7#e7 ,def]r+ a decision ,if ! ,adm9i/rator det]m9es t additional in=mation is requir$ to e/abli% ! priority ( a *emical sub/ance "u ?is section1 ! ,adm9i/rator may def] ! prioritization scre5+ decision = a reasonable p]iod-- 7,a7 to all[ = ! submission ( additional in=mation by an int]e/$ p]son & = ! ,adm9i/rator to evaluate ! additional in=mation2 or 7,b7 to require ! developm5t ( in=mation pursuant to a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u section #d7;a77#b74 7#f7 ,deadl9es = submission ( in=mation ,if ! ,adm9i/rator reque/s ! developm5t or submission ( in=mation "u ?is section1 ! ,adm9i/rator %all e/abli% a deadl9e = submission ( ! in=mation4 7#g7 ,notice & comm5t ,! ,adm9i/rator %all-- 7,a7 publi%1 includ+ 9 ! ,f$]al ,regi/]1 ! propos$ decisions made "u p>agraphs 7#c71 7#d71 & 7#e7 & ! basis = ! decisions2 & 7,b7 provide #ij days = public comm5t4 7#h7 ,revisions ( prior designations 7,a7 ,9 g5]al ,at any "t1 & at ! discretion ( ! ,adm9i/rator1 ! ,adm9i/rator may revise ! designation ( a *emical sub/ance z a high-priority sub/ance or a l[-priority sub/ance bas$ on in=mation available to ! ,adm9i/rator aft] ! date ( ! det]m9ation "u p>agraph 7#c7 or 7#d74 7,b7 ,limit$ availability ,if limit$ availability ( relevant in=mation 0 a basis 9 ! designation ( a *emical sub/ance z a high-priority sub/ance1 ! ,adm9i/rator %all reevaluate ! prioritization scre5+ ( ! *emical sub/ance on receiv+ ! relevant in=mation4 7#i7 ,o!r in=mation relevant to prioritization 7,a7 ,9 g5]al ,if1 aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 a ,/ate proposes an adm9i/rative action or enacts a /atute or takes an adm9i/rative action to prohibit or o!rwise re/rict ! manufactur+1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance t ! ,adm9i/rator has n designat$ z a high-priority sub/ance1 ! ,gov]nor or ,/ate ag5cy ) responsibility = implem5t+ ! /atute or adm9i/rative action %all notify ! ,adm9i/rator4 7,b7 ,reque/s = in=mation ,foll[+ receipt ( a notification provid$ "u subp>agraph 7,a71 ! ,adm9i/rator may reque/ any available in=mation f ! ,gov]nor or ! ,/ate ag5cy ) respect to-- 7i7 sci5tific evid5ce relat$ to ! haz>ds1 exposures & risks ( ! *emical sub/ance "u ! conditions ( use :i* ! /atute or adm9i/rative action is int5d$ to address2 7ii7 any ,/ate or local conditions :i* w>rant$ ! /atute or adm9i/rative action2 7iii7 ! /atutory or adm9i/rative au?ority on :i* ! action is bas$2 & 7iv7 any o!r available in=mation relevant to ! prohibition or o!r re/riction1 includ+ in=mation on any alt]natives consid]$ & _! haz>ds1 exposures1 & risks4 7,c7 ,prioritization scre5+ ,! ,adm9i/rator %all conduct a prioritization scre5+ "u ?is subsection = all sub/ances t-- 7i7 are ! subject ( notifications receiv$ "u subp>agraph 7,a72 & 7ii7 ! ,adm9i/rator det]m9es-- 7,i7 are likely to h significant heal? or environm5tal impacts2 7,,ii7 are likely to h significant impact on int]/ate comm]ce2 or 7,,iii7 h be5 subject to a prohibition or o!r re/riction "u a /atute or adm9i/rative action 9 #b or m ,/ates4 7,d7 ,availability to public ,subject to section #ad & any applicable ,/ate law reg>d+ ! protection ( confid5tial in=mation provid$ to ! ,/ate or to ! ,adm9i/rator1 ! ,adm9i/rator %all make in=mation receiv$ f a ,gov]nor or ,/ate ag5cy "u subp>agraph 7,a7 publicly available4 7,e7 ,effect ( p>agraph ,no?+ 9 ?is p>agraph %all preempt a ,/ate /atute or adm9i/rative action1 require approval ( a ,/ate /atute or adm9i/rative action1 or apply section #ae to a ,/ate4 7#aj7 ,review ,n less frequ5tly ?an once e #e ye>s aft] ! date on :i* ! process "u ?is subsection is e/abli%$1 ! ,adm9i/rator %all-- 7,a7 review ! process on ! basis ( exp]i5ce & tak+ into consid]ation res\rces available to effici5tly & effectively scre5 & prioritize *emical sub/ances2 & 7,b7 if necess>y1 modify ! prioritization scre5+ process4 7#aa7 ,effect ,subject to section #ah1 a designation by ! ,adm9i/rator "u ?is section ) respect to a *emical sub/ance %all n affect-- 7,a7 ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( ! *emical sub/ance2 or 7,b7 ! regulation ( ^? activities4 7c7 ,additional priorities = safety assessm5ts & det]m9ations 7#a7 ,requirem5ts 7,a7 ,9 g5]al ,! prioritization scre5+ process develop$ "u subsection 7a7 %all-- 7i7 include a process by :i* a manufactur] or processor ( an active *emical sub/ance t has n be5 designat$ a high-priority sub/ance or is n 9 ! process ( a prioritization scre5+ by ! ,adm9i/rator1 may reque/ t ! ,adm9i/rator designate ! sub/ance z an additional priority = a safety assessm5t & safety det]m9ation1 subject to ! paym5t ( fees pursuant to section #bf7;b77#c77;,e72 7ii7 specify ! in=mation to be provid$ 9 su* reque/s2 & 7iii7 specify ! crit]ia ! ,adm9i/rator %all use to det]m9e :e!r or n to grant su* a reque/1 :i* %all include :e!r ! sub/ance is subject to re/rictions impos$ by /atutes enact$ or adm9i/rative actions tak5 by #a or m ,/ates on ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( ! sub/ance4 7,b7 ,pref]5ce ,subject to p>agraph 7#b71 9 decid+ :e!r to grant reque/s "u ?is subsection ! ,adm9i/rator %all give a pref]5ce to reque/s conc]n+ sub/ances = :i* ! ,adm9i/rator det]m9es t re/rictions impos$ by #a or m ,/ates h ! pot5tial to h a significant impact on int]/ate comm]ce or heal? or ! environm5t4 7,c7 ,exceptions ,*emical sub/ances = :i* reque/s h be5 grant$ "u ?is subsection %all n be subject to subsection 7a77#c77;,a77iii7 or section #ah7;b74 7#b7 ,limitations ,9 consid]+ :e!r to grant a reque/ submitt$ "u p>agraph 7#a71 ! ,adm9i/rator %all ensure t-- 7,a7 if a suffici5t numb] ( additional priority reque/s meet ! requirem5ts ( p>agraph 7#a71 n less ?an #be p]c5t1 or m ?an #cj p]c5t1 ( ! cumulative numb] ( sub/ances designat$ to und]go safety assessm5ts & safety det]m9ations "u subsections 7a77#b7 & 7b77#c7 are sub/ances designat$ "u ! process & crit]ia pursuant to p>agraph 7#a72 7,b7 ! res\rces allocat$ to conduct+ safety assessm5ts & safety det]m9ations = additional priorities designat$ "u ?is subsection are proportionate to ! numb] ( su* sub/ances relative to ! total numb] ( sub/ances designat$ to und]go safety assessm5ts & safety det]m9ations "u ?is section2 & 7,c7 ! numb] ( additional priority reque/s /ipulat$ "u subp>agraph 7,a7 is 9 addition to ! total numb] ( high-priority sub/ances id5tifi$ "u subsections 7a77#b7 & 7b77#c74 7#c7 ,additional review ( "w plan *emicals = safety assessm5t & safety det]m9ation ,9 ! case ( a reque/ "u p>agraph 7#a7 ) respect to a *emical sub/ance id5tifi$ by ! ,adm9i/rator 9 ! ,octob] #bjad ,"w ,plan-- 7,a7 ! #cj-p]c5t cap specifi$ 9 p>agraph 7#b77;,a7 %all n apply & ! addition ( ,"w ,plan *emicals %all be at ! discretion ( ! ,adm9i/rator2 & 7,b7 not)/&+ p>agraph 7#a77;,c71 reque/s = additional ,"w ,plan *emicals "u ?is subsection %all be consid]$ high-priority *emicals subject to section #ah7;b7 b n subsection 7a77#c77;,a77iii74 7#d7 ,requirem5ts 7,a7 ,9 g5]al ,! public %all be provid$ notice & an opportunity to comm5t on reque/s submitt$ "u ?is subsection4 7,b7 ,decision by ,adm9i/rator ,n lat] ?an #ahj days aft] ! date on :i* ! ,adm9i/rator receives a reque/ "u ?is subsection1 ! ,adm9i/rator %all decide :e!r or n to grant ! reque/4 7,c7 ,assessm5t & det]m9ation ,if ! ,adm9i/rator grants a reque/ "u ?is subsection1 ! safety assessm5t & safety det]m9ation-- 7i7 %all be conduct$ 9 accordance ) ! deadl9es & o!r requirem5ts ( sections #c;,a7i7 & #f2 & 7ii7 %all n be exp$it$ or o!rwise subject to special treatm5t relative to high-priority sub/ances designat$ pursuant to subsection 7b77#c7 t are und]go+ safety assessm5ts & safety det]m9ations4 4 #g4 ,new *emicals & significant new uses ,section #e ( ! ,toxic ,sub/ances ,control ,act 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 by /rik+ subsection 7b72 7#c7 by r$esignat+ subsection 7a7 z subsection 7b72 7#d7 by r$esignat+ subsection 7i7 z subsection 7a7 & mov+ ! subsection s z to appe> at ! beg9n+ ( ! section2 7#e7 9 subsection 7b7 7z s r$esignat$7-- 7,a7 9 ! subsection head+1 by /rik+ ,9 g5]al & ins]t+ ,notices2 7,b7 9 p>agraph 7#a7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ subsection 7h7 & ins]t+ p>agraph 7#c7 & subsection 7h72 & 7ii7 9 ! matt] foll[+ subp>agraph 7,b7-- 7,i7 by /rik+ subsection 7d7 & ins]t+ subsection 7c72 & 7,,ii7 by /rik+ & su* p]son complies ) any applicable requirem5t ( subsection 7b72 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,article consid]ation ,! ,adm9i/rator may require ! notification = ! import or process+ ( a *emical sub/ance z "p ( an article or category ( articles "u p>agraph 7#a77;,b7 if ! ,adm9i/rator makes an affirmative f9d+ 9 a rule "u p>agraph 7#b7 t ! reasonable pot5tial = exposure to ! *emical sub/ance ?r\gh ! article or category ( articles subject to ! rule w>rants notification4 2 7#f7 by r$esignat+ subsections 7c7 & 7d7 z subsections 7d7 & 7c71 respectively1 & mov+ subsection 7c7 7z s r$esign$7 s z appe> aft] subsection 7b7 7z r$esignat$ by p>agraph 7#c772 7#g7 9 subsection 7c7 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 7b7 %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+ conditions ( use & reasonably anticipat$ exposures4 2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a7-- 7,i7 by /rik+ subsection 7a7 & ins]t+ subsection 7b72 & 7,,ii7 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+ subsection 7a7 & = :i* ! notification p]iod prescrib$ by subsection 7a71 7b71 or 7c7 & ins]t+ subsection 7b7 & = :i* ! notification p]iod prescrib$ by subsection 7b7 or 7d72 7#h7 by /rik+ subsection 7d7 7z r$esignat$ by p>agraph 7#f77 & ins]t+ ! foll[+3 7d7 ,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 7b71 ! ,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#c74 7,b7 ,ext5sion ,except z provid$ 9 p>agraph 7#e71 ! ,adm9i/rator may ext5d ! p]iod describ$ 9 subp>agraph 7,a7 = good cause = #a or m p]iods1 ! total ( :i* %all be n m ?an #ij days4 7#b7 ,in=mation s\rces ,9 evaluat+ a notice "u p>agraph 7#a71 ! ,adm9i/rator %all take into consid]ation-- 7,a7 any relevant in=mation id5tifi$ 9 subsection 7c77#a72 & 7,b7 any o!r relevant additional in=mation available to ! ,adm9i/rator4 7#c7 ,det]m9ations ,be=e ! end ( ! applicable p]iod = review "u p>agraph 7#a71 bas$ on ! in=mation describ$ 9 p>agraph 7#b71 & subject to section #ah7;g71 ! ,adm9i/rator %all det]m9e t-- 7,a7 ! relevant *emical sub/ance or significant new use is n likely to meet ! safety /&>d1 9 :i* case ! ,adm9i/rator %all take appropriate action "u p>agraph 7#d72 7,b7 ! relevant *emical sub/ance or significant new use is likely to meet ! safety /&>d1 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>agraphs 7#d7 & 7#e74 7#d7 ,re/rictions 7,a7 ,det]m9ation by ,adm9i/rator 7i7 ,9 g5]al ,if ! ,adm9i/rator makes a det]m9ation "u subp>agraph 7,a7 or 7,c7 ( p>agraph 7#c7 ) respect to a notice submitt$ "u subsection 7b7-- 7,i7 ! ,adm9i/rator1 be=e ! end ( ! applicable p]iod = review "u p>agraph 7#a7 & by cons5t agreem5t or ord]1 z appropriate1 %all prohibit or o!rwise re/rict ! manufacture1 process+1 use1 di/ribution 9 comm]ce1 or disposal 7z applicable7 ( ! *emical sub/ance1 or ( ! *emical sub/ance = a significant new use1 )\t compliance ) ! re/rictions specifi$ 9 ! cons5t agreem5t or ord] t ! ,adm9i/rator det]m9es are suffici5t to ensure t ! *emical sub/ance or significant new use is likely to meet ! safety /&>d2 & 7,,ii7 no p]son may comm5ce manufacture ( ! *emical sub/ance1 or manufacture or process+ ( ! *emical sub/ance = a significant new use1 except 9 compliance ) ! re/rictions specifi$ 9 ! cons5t agreem5t or ord]4 7ii7 ,likely to meet /&>d ,if ! ,adm9i/rator makes a det]m9ation "u subp>agraph 7,b7 ( p>agraph 7#c7 ) respect to a *emical sub/ance or significant new use = :i* a notice 0 submitt$ "u subsection 7b71 at ! end ( ! applicable p]iod = review "u p>agraph 7#a71 ! submitt] ( ! notice may comm5ce manufacture = comm]cial purposes ( ! *emical sub/ance or manufacture or process+ ( ! *emical sub/ance = a significant new use4 7,b7 ,requirem5ts ,n lat] ?an #ij days aft] issu+ a cons5t agreem5t or ord] "u subp>agraph 7,a71 ! ,adm9i/rator %all-- 7i7 take into consid]ation :e!r to promulgate a rule pursuant to subsection 7b77#b7 t id5tifies z a significant new use any manufactur+1 process+1 use1 di/ribution 9 comm]ce1 or disposal ( ! *emical sub/ance1 or ( ! *emical sub/ance = a new use1 t is n 9 compliance ) ! re/rictions impos$ by ! cons5t agreem5t or ord]2 & 7ii7 7,i7 initiate a rulemak+ describ$ 9 clause 7i72 or 7,,ii7 publi% a /atem5t describ+ ! reasons ( ! ,adm9i/rator = n initiat+ a rulemak+4 7,c7 ,inclusions ,a prohibition or o!r re/riction "u subp>agraph 7,a7 may include1 z appropriate-- 7i7 subject to section #ah7;g71 a requirem5t t a *emical sub/ance %all be m>k$ )1 or accompani$ by1 cle> & adequate m9imum w>n+s & in/ructions ) respect to use1 di/ribution 9 comm]ce1 or disposal1 or any comb9ation ( ^? activities1 ) ! =m & cont5t ( ! m9imum w>n+s & in/ructions to be prescrib$ by ! ,adm9i/rator 7ii7 a requirem5t t manufactur]s or processors ( ! *emical sub/ance %all-- 7,i7 make & reta9 records ( ! processes us$ to manufacture or process1 z applicable1 ! *emical sub/ance2 or 7,,ii7 monitor or conduct su* additional te/s z are reasonably necess>y to address pot5tial risks f ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal1 z applicable1 ( ! *emical sub/ance1 subject to section #d2 7iii7 a re/riction on ! quantity ( ! *emical sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce-- 7,i7 9 g5]al2 or 7,,ii7 = a p>ticul> use2 7iv7 a prohibition or o!r re/riction (-- 7,i7 ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance = a significant new use2 7,,ii7 any me?od ( comm]cial use ( ! *emical sub/ance2 or 7,,iii7 any me?od ( disposal ( ! *emical sub/ance2 or 7v7 a prohibition or o!r re/riction on ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance-- 7,i7 9 g5]al2 or 7,,ii7 = a p>ticul> use4 7,d7 ,p]si/5t & bioaccumulative sub/ances ,= a *emical sub/ance ! ,adm9i/rator det]m9es ranks high = p]si/5ce & bioaccumulation1 ! ,adm9i/rator %all1 9 select+ among prohibitions & o!r re/rictions t ! ,adm9i/rator det]m9es are suffici5t to ensure t ! *emical sub/ance is likely to meet ! safety /&>d1 r$uce pot5tial exposure to ! sub/ance to ! maximum ext5t practicable4 7,e7 ,workplace exposures ,! ,adm9i/rator %all consult ) ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal? prior to adopt+ any prohibition or o!r re/riction "u ?is subsection to address workplace exposures4 7,f7 ,def9ition ( requirem5t ,= purposes ( ?is ,act1 ! t]m requirem5t z us$ 9 ?is section does n displace common law4 7#e7 ,additional in=mation ,if ! ,adm9i/rator det]m9es "u p>agraph 7#c77;,c7 t additional in=mation is necess>y to conduct a review "u ?is subsection1 ! ,adm9i/rator-- 7,a7 %all provide an opportunity = ! submitt] ( ! notice to submit ! 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 may promulgate a rule1 ent] into a te/+ cons5t agreem5t1 or issue an ord] "u section #d to require ! developm5t ( ! in=mation2 & 7,d7 on receipt ( in=mation ! ,adm9i/rator f9ds supports ! det]m9ation "u p>agraph 7#c71 %all promptly make ! det]m9ation4 2 7#i7 by /rik+ subsections 7e7 ?r\gh 7g7 & ins]t+ ! foll[+3 7e7 ,notice ( comm5cem5t 7#a7 ,9 g5]al ,n lat] ?an #cj days aft] ! date on :i* a manufactur] t has submitt$ a notice "u subsection 7b7 comm5ces nonexempt comm]cial manufacture ( a *emical sub/ance1 ! manufactur] %all submit to ! ,adm9i/rator a notice ( comm5cem5t t id5tifies-- 7,a7 ! "n ( ! manufactur]2 & 7,b7 ! initial date ( nonexempt comm]cial manufacture4 7#b7 ,)drawal ,a manufactur] or processor t has submitt$ a notice "u subsection 7b71 b t has n comm5c$ nonexempt comm]cial manufacture or process+ ( ! *emical sub/ance1 may )draw ! notice4 7f7 ,fur!r evaluation ,! ,adm9i/rator may review a *emical sub/ance "u section #d;,a at any "t aft] ! ,adm9i/rator receives-- 7#a7 a notice ( comm5cem5t = a *emical sub/ance "u subsection 7e72 or 7#b7 new in=mation reg>d+ ! *emical sub/ance4 7g7 ,transp>5cy ,subject to section #ad1 ! ,adm9i/rator %all make available to ! public-- 7#a7 all notices1 det]m9ations1 cons5t agreem5ts1 rules1 & ord]s ( ! ,adm9i/rator2 & 7#b7 all in=mation submitt$ or issu$ "u ?is section4 2 & 7#aj7 9 subsection 7h7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ 7a7 or2 & 7ii7 9 subp>agraph 7,a71 by ins]t+ 1 )\t tak+ into acc\nt co/ or o!r nonrisk factors aft] ! environm5t2 7,b7 by /rik+ p>agraph 7#b72 7,c7 by r$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$71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7b72 7,e7 9 p>agraph 7#c7 7z s r$esignat$7-- 7i7 9 ! fir/ s5t5ce1 by /rik+ w n pres5t an unreasonable risk ( injury to heal? or ! environm5t & ins]t+ w meet ! safety /&>d2 & 7ii7 by /rik+ ! second s5t5ce2 7,f7 9 p>agraph 7#d7 7z s r$esignat$71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7b72 & 7,g7 9 p>agraph 7#e7 7z s r$esignat$71 9 ! fir/ s5t5ce1 by /rik+ p>agraph 7#a7 or 7#e7 & ins]t+ p>agraph 7#a7 or 7#d74 #h4 ,safety assessm5ts & safety det]m9ations ,section #f ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfje7 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & ins]t+ ! foll[+3 #f4 ,safety assessm5ts & safety det]m9ations 2 7#b7 by r$esignat+ subsections 7e7 & 7f7 z subsections 7g7 & 7h71 respectively2 7#c7 by /rik+ subsections 7a7 ?r\gh 7d7 & ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,adm9i/rator-- 7#a7 %all conduct a safety assessm5t & make a safety det]m9ation ( ea* high-priority sub/ance 9 accordance ) subsections 7b7 & 7c72 7#b7 %all1 z soon z practicable & n lat] ?an #f mon?s aft] ! date on :i* a *emical sub/ance is designat$ z a high-priority sub/ance1 def9e & publi% ! scope ( ! safety assessm5t & safety det]m9ation to be conduct$ pursuant to ?is section1 includ+ ! haz>ds1 exposures1 conditions ( use1 & pot5tially expos$ or susceptible populations t ! ,adm9i/rator expects to consid]2 7#c7 z appropriate bas$ on ! results ( a safety det]m9ation1 %all e/abli% re/rictions pursuant to subsection 7d72 7#d7 %all complete a safety assessm5t & safety det]m9ation n lat] ?an #c ye>s aft] ! date on :i* a *emical sub/ance is designat$ z a high-priority sub/ance2 7#e7 %all promulgate a f9al rule pursuant to subsection 7d7 by n lat] ?an #b ye>s aft] ! date on :i* ! safety det]m9ation is complet$2 & 7#f7 may ext5d any deadl9e "u p>agraph 7#d7 or 7#e7 = a reasonable p]iod ( "t aft] an adequate public ju/ification1 subject to ! condition t ! aggregate l5g? ( all ext5sions ( deadl9es "u ?is subsection1 plus any def]ral "u subsection 7c77#b71 does n exce$ #b ye>s4 7b7 ,prior actions & notice ( exi/+ in=mation 7#a7 ,prior-initiat$ assessm5ts 7,a7 ,9 g5]al ,no?+ 9 ?is ,act prev5ts ! ,adm9i/rator f initiat+ a safety assessm5t or safety det]m9ation reg>d+ a *emical sub/ance1 or f cont9u+ or complet+ su* a safety assessm5t or safety det]m9ation t 0 initiat$ be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 prior to ! effective date ( ! policies & proc$ures requir$ to be e/abli%$ by ! ,adm9i/rator "u section #c;,a or #d;,a4 7,b7 ,integration ( prior policies & proc$ures ,z policies & proc$ures "u section #c;,a & #d;,a are e/abli%$1 to ! maximum ext5t practicable1 ! ,adm9i/rator %all integrate ! policies & proc$ures into ongo+ safety assessm5ts & safety det]m9ations4 7#b7 ,actions complet$ prior to completion ( policies & proc$ures ,no?+ 9 ?is ,act requires ! ,adm9i/rator to revise or )draw a complet$ safety assessm5t1 safety det]m9ation1 or rule solely because ! action 0 complet$ prior to ! completion ( a policy or proc$ure e/abli%$ "u section #c;,a or #d;,a1 & ! validity ( a complet$ assessm5t1 det]m9ation1 or rule %all n be det]m9$ bas$ on ! cont5t ( su* a policy or proc$ure4 7#c7 ,notice ( exi/+ in=mation 7,a7 ,9 g5]al ,! ,adm9i/rator %all1 :]e su* in=mation is available1 take notice ( exi/+ in=mation reg>d+ haz>d & exposure publi%$ by o!r ,f$]al ag5cies & ! ,national ,academies & incorporate ! in=mation 9 safety assessm5ts & safety det]m9ations ) ! objective ( increas+ ! effici5cy ( ! safety assessm5ts & safety det]m9ations4 7,b7 ,inclusion ( in=mation ,exi/+ in=mation describ$ 9 subp>agraph 7,a7 %\ld be includ$ to ! ext5t practicable & :]e ! ,adm9i/rator det]m9es ! in=mation is relevant & sci5tifically reliable4 7c7 ,safety det]m9ations 7#a7 ,9 g5]al ,bas$ on a review ( ! in=mation available to ! ,adm9i/rator1 includ+ draft safety assessm5ts submitt$ by int]e/$ p]sons1 & subject to section #ah1 ! ,adm9i/rator %all det]m9e t-- 7,a7 ! relevant *emical sub/ance meets ! safety /&>d2 7,b7 ! relevant *emical sub/ance does n meet ! safety /&>d1 9 :i* case ! ,adm9i/rator %all1 by rule "u subsection 7d7-- 7i7 impose re/rictions necess>y to ensure t ! *emical sub/ance meets ! safety /&>d "u ! conditions ( use2 or 7ii7 if ! safety /&>d _c be met ) ! application ( re/rictions1 ban or phase out ! *emical sub/ance1 z appropriate2 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#b74 7#b7 ,additional in=mation ,if ! ,adm9i/rator det]m9es t additional in=mation is necess>y to make a safety assessm5t or safety det]m9ation = 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]iod consi/5t ) ! deadl9es describ$ 9 subsection 7a71 a safety assessm5t & safety det]m9ation until aft] receipt ( ! in=mation2 & 7,d7 consi/5t ) ! deadl9es describ$ 9 subsection 7a71 on receipt ( in=mation ! ,adm9i/rator f9ds supports ! safety assessm5t & safety det]m9ation1 %all make a det]m9ation "u p>agraph 7#a74 7#c7 ,e/abli%m5t ( deadl9e ,9 reque/+ ! developm5t or submission ( in=mation "u ?is section1 ! ,adm9i/rator %all e/abli% a deadl9e = ! submission ( ! in=mation4 7d7 ,rule 7#a7 ,implem5tation ,if ! ,adm9i/rator makes a det]m9ation "u subsection 7c77#a77;,b7 ) respect to a *emical sub/ance1 ! ,adm9i/rator %all promulgate a rule e/abli%+ re/rictions necess>y to ensure t ! *emical sub/ance meets ! safety /&>d4 7#b7 ,scope 7,a7 ,9 g5]al ,! rule promulgat$ pursuant to ?is subsection-- 7i7 may apply to mixtures conta9+ ! *emical sub/ance1 z appropriate2 7ii7 %all include dates by :i* compliance is m&atory1 :i*-- 7,i7 %all be z soon z practicable2 7,,ii7 9 ! case ( a ban or phase-out ( ! *emical sub/ance1 %all implem5t ! ban or phase-out 9 z %ort a p]iod z practicable2 & 7,,iii7 z det]m9$ by ! ,adm9i/rator1 may v>y = diff]5t affect$ p]sons2 & 7iii7 %all exempt replacem5t p>ts t are manufactur$ prior to ! effective date ( ! rule = articles t are fir/ manufactur$ prior to ! effective date ( ! rule unless ! ,adm9i/rator f9ds ! replacem5t p>ts contribute significantly to ! id5tifi$ risk2 & 7iv7 %all1 9 select+ among prohibitions & o!r re/rictions1 apply su* prohibitions or o!r re/rictions to articles conta9+ ! *emical sub/ance only to ! ext5t necess>y to address ! id5tifi$ risks 9 ord] to det]m9e t ! *emical sub/ance meets ! safety /&>d4 7,b7 ,p]si/5t & bioaccumulative sub/ances ,= a *emical sub/ance ! ,adm9i/rator det]m9es ranks high = p]si/5ce & bioaccumulation1 ! ,adm9i/rator %all1 9 select+ among prohibitions & o!r re/rictions t ! ,adm9i/rator det]m9es are suffici5t to ensure t ! *emical sub/ance meets ! safety /&>d1 r$uce exposure to ! sub/ance to ! maximum ext5t practicable4 7,c7 ,workplace exposures ,! ,adm9i/rator %all consult ) ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal? be=e adopt+ any prohibition or o!r re/riction "u ?is subsection to address workplace exposures4 7,d7 ,def9ition ( requirem5t ,= ! purposes ( ?is ,act1 ! t]m requirem5t z us$ 9 ?is section does n displace common law4 7#c7 ,re/rictions ,a re/riction "u p>agraph 7#a7 may include1 z appropriate-- 7,a7 subject to section #ah1 a requirem5t t a *emical sub/ance %all be m>k$ )1 or accompani$ by1 cle> & adequate m9imum w>n+s & in/ructions ) respect to use1 di/ribution 9 comm]ce1 or disposal1 or any comb9ation ( ^? activities1 ) ! =m & cont5t ( ! m9imum w>n+s & in/ructions to be prescrib$ by ! ,adm9i/rator2 7,b7 a requirem5t t manufactur]s or processors ( ! *emical sub/ance %all-- 7i7 make & reta9 records ( ! processes us$ to manufacture or process ! *emical sub/ance2 7ii7 describe & apply ! relevant quality control proc$ures foll[$ 9 ! manufactur+ or process+ ( ! sub/ance2 or 7iii7 monitor or conduct te/s t are reasonably necess>y to ensure compliance ) ! requirem5ts ( any rule "u ?is subsection2 7,c7 a re/riction on ! quantity ( ! *emical sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce2 7,d7 a requirem5t to ban or phase out1 or any o!r rule reg>d+1 ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance =-- 7i7 a p>ticul> use2 7ii7 a p>ticul> use at a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator2 or 7iii7 all uses2 7,e7 a re/riction on ! quantity ( ! *emical sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce =-- 7i7 a p>ticul> use2 or 7ii7 a p>ticul> use at a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator2 7,f7 a requirem5t to ban1 phase out1 or o!rwise re/rict any me?od ( comm]cial use ( ! *emical sub/ance2 7,g7 a requirem5t to ban1 phase out1 or o!rwise re/rict any me?od ( disposal ( ! *emical sub/ance or any article conta9+ ! *emical sub/ance2 & 7,h7 a requirem5t direct+ manufactur]s or processors ( ! *emical sub/ance to give notice ( ! ,adm9i/rator's det]m9ation "u subsection 7c77#a77;,b7 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/ance4 7#d7 ,analysis = rulemak+ 7,a7 ,consid]ations ,9 decid+ :i* re/rictions to impose "u p>agraph 7#c7 z "p ( develop+ a rule "u p>agraph 7#a71 ! ,adm9i/rator %all take into consid]ation1 to ! ext5t practicable bas$ on reasonably available in=mation1 ! quantifiable & nonquantifiable co/s & b5efits ( ! propos$ regulatory action & ( ! #a or m prim>y alt]native regulatory actions consid]$ by ! ,adm9i/rator4 7,b7 ,alt]natives ,z "p ( ! analysis1 ! ,adm9i/rator %all review any #a or m te*nically & economically feasible alt]natives to ! *emical sub/ance t ! ,adm9i/rator det]m9es are relevant to ! rulemak+4 7,c7 ,public availability ,9 propos+ a rule "u p>agraph 7#a71 ! ,adm9i/rator %all make publicly available any analysis conduct$ "u ?is p>agraph4 7,d7 ,/atem5t requir$ ,9 mak+ f9al a rule "u p>agraph 7#a71 ! ,adm9i/rator %all include a /atem5t describ+ h[ ! analysis consid]$ "u subp>agraph 7,a7 0 tak5 into acc\nt4 7#e7 ,exemptions 7,a7 ,9 g5]al ,! ,adm9i/rator may exempt #a or m uses ( a *emical sub/ance f any re/riction 9 a rule promulgat$ "u p>agraph 7#a7 if ! ,adm9i/rator det]m9es t-- 7i7 ! rule _c be compli$ )1 )\t-- 7,i7 h>m+ national security2 7,,ii7 caus+ significant disruption 9 ! national economy due to ! lack ( availability ( a *emical sub/ance2 or 7,,iii7 int]f]+ ) a critical or ess5tial use = :i* no te*nically & economically feasible saf] alt]native is available1 tak+ into consid]ation haz>d & exposure2 or 7ii7 ! use ( ! *emical sub/ance1 z comp>$ to reasonably available alt]natives1 provides a sub/antial b5efit to heal?1 ! environm5t1 or public safety4 7,b7 ,exemption analysis ,9 propos+ a rule "u p>agraph 7#a7 t includes an exemption "u ?is p>agraph1 ! ,adm9i/rator %all make publicly available any analysis conduct$ "u ?is p>agraph to assess ! ne$ = ! exemption4 7,c7 ,/atem5t requir$ ,9 mak+ f9al a rule "u p>agraph 7#a7 t includes an exemption "u ?is p>agraph1 ! ,adm9i/rator %all include a /atem5t describ+ h[ ! analysis consid]$ "u subp>agraph 7,b7 0 tak5 into acc\nt4 7,d7 ,analysis 9 case ( ban or phase-out ,9 det]m9+ :e!r an exemption %\ld be grant$ "u ?is p>agraph = a *emical sub/ance = :i* a ban or phase-out is propos$1 ! ,adm9i/rator %all take into consid]ation1 to ! ext5t practicable bas$ on reasonably available in=mation1 ! quantifiable & nonquantifiable co/s & b5efits ( ! #a or m te*nically & economically feasible alt]natives to ! *emical sub/ance mo/ likely to be us$ 9 place ( ! *emical sub/ance "u ! conditions ( use if ! rule is promulgat$4 7,e7 ,conditions ,z "p ( a rule promulgat$ "u p>agraph 7#a71 ! ,adm9i/rator %all include conditions 9 any exemption e/abli%$ "u ?is p>agraph1 includ+ reasonable recordkeep+1 monitor+1 & report+ requirem5ts1 to ! ext5t t ! ,adm9i/rator det]m9es ! conditions are necess>y to protect heal? & ! environm5t :ile a*iev+ ! purposes ( ! exemption4 7,f7 ,duration 7i7 ,9 g5]al ,! ,adm9i/rator %all e/abli%1 z "p ( a rule "u p>agraph 7#a7 t conta9s an exemption "u ?is p>agraph1 a "t limit on any exemption = a "t to be det]m9$ by ! ,adm9i/rator z reasonable on a case-by-case basis4 7ii7 ,au?ority ( ,adm9i/rator ,! ,adm9i/rator1 by rule1 may ext5d1 modify1 or elim9ate ! exemption if ! ,adm9i/rator det]m9es1 on ! basis ( reasonably available in=mation & aft] adequate public ju/ification1 ! exemption w>rants ext5sion or is no long] necess>y4 7iii7 ,consid]ations 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 ! ,adm9i/rator %all issue exemptions & e/abli% "t p]iods by consid]+ factors det]m9$ by ! ,adm9i/rator to be relevant to ! goals ( fo/]+ innovation & ! developm5t ( alt]natives t meet ! safety /&>d4 7,,ii7 ,limitation ,any r5ewal ( an exemption 9 ! case ( a rule requir+ ! ban or phase-out ( a *emical sub/ance %all n exce$ #e ye>s4 7e7 ,imm$iate effect ,! ,adm9i/rator may decl>e a propos$ rule "u subsection 7d77#a7 to be effective on publication ( ! rule 9 ! ,f$]al ,regi/] & until ! effective date ( f9al action tak5 respect+ ! rule1 if-- 7#a7 ! ,adm9i/rator det]m9es t-- 7,a7 ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( ! *emical sub/ance or mixture subject to ! propos$ rule or any comb9ation ( ^? activities is likely to result 9 a risk ( s]i\s or widespread injury to heal? or ! environm5t be=e ! effective date2 & 7,b7 mak+ ! propos$ rule s effective is necess>y to protect ! public int]e/2 & 7#b7 9 ! case ( a propos$ rule to prohibit ! manufacture1 process+1 or di/ribution 9 comm]ce ( a *emical sub/ance or mixture because ( ! risk det]m9$ "u p>agraph 7#a77;,a71 a c\rt has grant$ relief 9 an action "u section #g ) respect to t risk associat$ ) ! *emical sub/ance or mixture4 7f7 ,f9al ag5cy action ,"u ?is section & subject to section #ah-- 7#a7 a safety det]m9ation1 & ! associat$ safety assessm5t1 = a *emical sub/ance t ! ,adm9i/rator det]m9es "u subsection 7c7 meets ! safety /&>d1 %all be consid]$ to be a f9al ag5cy action1 effective beg9n+ on ! date ( issuance ( ! f9al safety det]m9ation2 & 7#b7 a f9al rule promulgat$ "u subsection 7d77#a71 & ! associat$ safety assessm5t & safety det]m9ation t a *emical sub/ance does n meet ! safety /&>d1 %all be consid]$ to be a f9al ag5cy action1 effective beg9n+ on ! date ( promulgation ( ! f9al rule4 2 & 7#d7 9 subsection 7g7 7z r$esignat$ by p>agraph 7#b77-- 7,a7 by /rik+ p>agraph 7#d72 & 7,b7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#d74 #i4 ,imm95t haz>ds ,section #g ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjf7 is am5d$-- 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 ,unit$ ,/ates di/rict c\rt =-- 7,a7 seizure ( an imm95tly haz>d\s *emical sub/ance or mixture or any article conta9+ ! *emical sub/ance or mixture2 7,b7 relief 7z au?oriz$ by subsection 7b77 aga9/ any p]son t 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+ ! *emical 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>agraph1 not)/&+-- 7,a7 ! exi/5ce ( a decision1 rule1 cons5t agreem5t1 or ord] by ! ,adm9i/rator "u section #d1 #d;,a1 #e1 or #f or title ,,iv or ,,vi2 or 7,b7 ! p5d5cy ( any adm9i/rative or judicial proce$+ "u any provision ( ?is ,act4 2 7#b7 9 subsection 7b77#a71 by /rik+ unreasonable2 7#c7 9 subsection 7d71 by /rik+ section #f7;a7 & ins]t+ section #f7;d72 & 7#d7 9 subsection 7f71 9 ! fir/ s5t5ce1 by /rik+ & unreasonable4 #aj4 ,in=mation collection & report+ ,section #h ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjg7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#c77;,a77ii77,i7-- 7i7 by /rik+ #e7;b77#d7 & ins]t+ #e2 7ii7 by ins]t+ section #d or aft] 9 effect "u2 & 7iii7 by /rik+ #e7;e71 & ins]t+ #e7;d77#d722 & 7,b7 by add+ at ! end ! foll[+3 7#d7 ,rules 7,a7 ,deadl9e 7i7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator %all promulgate rules requir+ ! ma9t5ance ( records & ! report+ ( in=mation kn[n or reasonably asc]ta9able by ! 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 7ii7 ,modification ( prior rules ,9 c>ry+ out ?is subp>agraph1 ! ,adm9i/rator may modify1 z appropriate1 rules promulgat$ be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 7,b7 ,cont5ts ,! rules promulgat$ pursuant to subp>agraph 7,a7-- 7i7 may impose diff]5t report+ & recordkeep+ requirem5ts on manufactur]s & processors2 & 7ii7 %all include ! level ( detail necess>y to be report$1 includ+ ! mann] by :i* use & exposure in=mation may be report$4 7,c7 ,adm9i/ration ,9 implem5t+ ! report+ & recordkeep+ requirem5ts "u ?is p>agraph1 ! ,adm9i/rator %all take measures-- 7i7 to limit ! pot5tial = duplication 9 report+ requirem5ts2 7ii7 to m9imize ! impact ( ! rules on small manufactur]s & processors2 & 7iii7 to apply any report+ obligations to ^? p]sons likely to h in=mation relevant to ! effective implem5tation ( ?is title4 7#e7 ,guidance ,! ,adm9i/rator %all develop guidance relat+ to ! in=mation requir$ to be report$ "u ! rules promulgat$ "u ?is subsection4 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 ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,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 ,if an 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 ! 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 ,*emical sub/ances 9 comm]ce 7,a7 ,rules 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,adm9i/rator1 by rule1 %all require manufactur]s & processors to notify ! ,adm9i/rator1 by n lat] ?an #ahj days aft] ! date ( promulgation ( ! rule1 ( ea* *emical sub/ance on ! li/ publi%$ "u p>agraph 7#a7 t ! manufactur] or processor1 z applicable1 has manufactur$ or process$ = a nonexempt comm]cial purpose dur+ ! #aj-ye> p]iod end+ on ! day be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 7ii7 ,active sub/ances ,! ,adm9i/rator %all1 pursuant to p>agraph 7#e77;,a71 designate *emical sub/ances = :i* notices are receiv$ "u clause 7i7 to be active sub/ances on ! li/ publi%$ "u p>agraph 7#a74 7,b7 ,confid5tial *emical sub/ances ,! rule promulgat$ by ! ,adm9i/rator pursuant to subp>agraph 7,a7 %all require-- 7i7 ! ,adm9i/rator to ma9ta9 ! li/ "u p>agraph 7#a71 :i* %all include a confid5tial portion & a nonconfid5tial portion consi/5t ) ?is section & section #ad2 7ii7 a manufactur] or processor t is submitt+ a notice pursuant to subp>agraph 7,a7 = a *emical sub/ance on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 to indicate 9 ! notice :e!r ! manufactur] or processor seeks to ma9ta9 any exi/+ claim = protection aga9/ disclosure ( ! specific id5tity ( ! sub/ance z confid5tial pursuant to section #ad2 & 7iii7 ! sub/antiation ( ^? claims pursuant to section #ad & 9 accordance ) ! review plan describ$ 9 subp>agraph 7,c74 7,c7 ,review plan ,n lat] ?an #a ye> aft] ! date on :i* ! ,adm9i/rator compiles ! initial li/ ( active sub/ances pursuant to subp>agraph 7,a71 ! ,adm9i/rator %all promulgate a rule t e/abli%es a plan to review all claims to protect ! specific id5tities ( *emical sub/ances on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 t are notifi$ pursuant to subp>agraph 7,a7 or id5tifi$ z active sub/ances "u subsection 7f77#a74 7,d7 ,requirem5ts ( review plan ,! review plan "u subp>agraph 7,c7 %all-- 7i7 require1 at ! "t reque/$ by ! ,adm9i/rator1 all manufactur]s or processors ass]t+ claims "u subp>agraph 7,b7 to sub/antiate ! claim unless ! manufactur] or processor has sub/antiat$ ! claim 9 a submission made to ! ,adm9i/rator dur+ ! #e-ye> p]iod end+ on ! date ( ! reque/ by ! ,adm9i/rator2 7ii7 require ! ,adm9i/rator1 9 accordance ) section #ad-- 7,i7 to review ea* sub/antiation-- 7aa7 submitt$ pursuant to clause 7i7 to det]m9e if ! claim w>rants protection f disclosure2 & 7bb7 submitt$ previ\sly by a manufactur] or processor & reli$ on 9 lieu ( ! sub/antiation requir$ pursuant to clause 7i71 if ! sub/antiation has n be5 previ\sly review$ by ! ,adm9i/rator1 to det]m9e if ! claim w>rants protection f disclosure2 7,,ii7 approve1 modify1 or d5y ea* claim2 & 7,,iii7 except z provid$ 9 ?is section & section #ad1 protect f disclosure in=mation = :i* ! ,adm9i/rator approves su* a claim = a p]iod ( #aj ye>s1 unless1 prior to ! expiration ( ! p]iod-- 7aa7 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7bb7 ! ,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 section #ad7;g77#b72 & 7iii7 enc\rage manufactur]s or processors t h previ\sly made claims to protect ! specific id5tities ( *emical sub/ances id5tifi$ z inactive pursuant to subsection 7f77#b7 to review & ei!r )draw or sub/antiate ! claims4 7,e7 ,timel9e = completion ( reviews 7i7 ,9 g5]al ,! ,adm9i/rator %all implem5t ! review plan s z to complete reviews ( all claims specifi$ 9 subp>agraph 7,c7 n lat] ?an #e ye>s aft] ! date on :i* ! ,adm9i/rator compiles ! initial li/ ( active sub/ances pursuant to subp>agraph 7,a74 7ii7 ,consid]ations 7,i7 ,9 g5]al ,! ,adm9i/rator may ext5d ! deadl9e = completion ( ! reviews = n m ?an #b additional ye>s1 aft] an adequate public ju/ification1 if ! ,adm9i/rator det]m9es t ! ext5sion is necess>y bas$ on ! numb] ( applicable claims ne$+ review & ! available res\rces4 7,,ii7 ,annual goal ,! ,adm9i/rator %all publi% an annual goal = ! numb] ( reviews to be complet$ ov] ! c\rse ( implem5tation ( ! plan4 7#e7 ,active & inactive sub/ances 7,a7 ,9 g5]al ,! ,adm9i/rator %all ma9ta9 & keep curr5t designations ( active sub/ances & inactive sub/ances on ! li/ publi%$ "u p>agraph 7#a74 7,b7 ,update ,! ,adm9i/rator %all update ! li/ ( *emical sub/ances designat$ z active sub/ances z soon z practicable aft] ! date ( publication ( ! mo/ rec5t data report$ "u-- 7i7 "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations72 & 7ii7 ! rules promulgat$ pursuant to subsection 7a77#d74 7,c7 ,*ange to active /atus 7i7 ,9 g5]al ,any p]son t 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* ! inactive sub/ance is manufactur$ or process$4 7ii7 ,confid5tial *emical id5tity claims ,if a p]son submitt+ a notice "u clause 7i7 = an inactive sub/ance on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 seeks to ma9ta9 an exi/+ claim = protection aga9/ disclosure ( ! specific id5tity ( ! inactive sub/ance z confid5tial1 ! p]son %all-- 7,i7 9 ! notice submitt$ "u clause 7i71 ass]t ! claim2 & 7,,ii7 by n lat] ?an #cj days aft] provid+ ! notice "u clause 7i71 sub/antiate ! claim4 7iii7 ,active /atus ,on receiv+ a notification "u clause 7i71 ! ,adm9i/rator %all-- 7,i7 designate ! applicable *emical sub/ance z an active sub/ance2 7,,ii7 pursuant to section #ad1 promptly review any claim & associat$ sub/antiation submitt$ pursuant to clause 7ii7 = protection aga9/ disclosure ( ! specific id5tity ( ! *emical sub/ance & approve1 modify1 or d5y ! claim2 7,,iii7 except z provid$ 9 ?is section & section #ad1 protect f disclosure ! specific id5tity ( ! *emical sub/ance = :i* ! ,adm9i/rator approves a claim "u subclause 7,,ii7 = a p]iod ( n less ?an #aj ye>s1 unless1 prior to ! expiration ( ! p]iod-- 7aa7 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7bb7 ! ,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 section #ad7;g77#b72 & 7,,iv7 pursuant to section #d;,a1 review ! priority ( ! *emical sub/ance z ! ,adm9i/rator det]m9es to be necess>y4 7,d7 ,category /atus ,! li/ ( inactive sub/ances %all n be consid]$ to be a category = purposes ( section #bf7;c74 7#f7 ,int]im li/ ( active sub/ances ,prior to ! promulgation ( ! rule requir$ "u p>agraph 7#d77;,a71 ! ,adm9i/rator %all designate ! *emical sub/ances report$ "u "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations71 dur+ ! report+ p]iod t mo/ closely prec$$ ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 z ! int]im li/ ( active sub/ances = ! purposes ( section #d;,a4 7#g7 ,public p>ticipation ,subject to ?is subsection1 ! ,adm9i/rator %all make available to ! public-- 7,a7 ! specific id5tity ( ea* *emical sub/ance on ! nonconfid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 t ! ,adm9i/rator has designat$ z-- 7i7 an active sub/ance2 or 7ii7 an inactive sub/ance2 7,b7 ! 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$ & approv$ by ! ,adm9i/rator pursuant to section #ad2 & 7,c7 subject to section #ad7;g71 ! specific id5tity ( any active sub/ance = :i*-- 7i7 no claim ( protection aga9/ disclosure ( ! specific id5tity ( ! active sub/ance pursuant to ?is subsection 0 receiv$2 7ii7 a claim = protection aga9/ disclosure ( ! specific id5tity ( ! active sub/ance has be5 d5i$ by ! ,adm9i/rator2 or 7iii7 ! "t p]iod = protection aga9/ disclosure ( ! specific id5tity ( ! active sub/ance has expir$4 7#h7 ,limitation ,no p]son may ass]t a new claim "u ?is subsection = protection f disclosure ( a specific id5tity ( any active or inactive *emical sub/ance = :i* a notice is receiv$ "u p>agraph 7#d77;,a77i7 or 7#e77;,c77i7 t is n on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a74 7#i7 ,c]tification ,"u ! rules promulgat$ "u ?is subsection1 manufactur]s & processors %all be requir$-- 7,a7 to c]tify t ea* report ! manufactur] or processor submits complies ) ! requirem5ts ( ! rule1 & t any confid5tiality claims are true & correct2 & 7,b7 to reta9 a record support+ ! c]tification = a p]iod ( #e ye>s beg9n+ on ! la/ day ( ! submission p]iod4 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 in=mation reasonably support+ ! conclusion t a *emical sub/ance or mixture pres5ts1 w pres5t1 or does n pres5t a sub/antial risk ( injury to heal? & ! environm5t4 2 & 7#d7 9 subsection 7f71 by /rik+ ,= purposes ( ?is section1 ! & ins]t+ ! foll[+3 ,9 ?is section3 7#a7 ,active sub/ance ,! t]m active sub/ance means a *emical sub/ance-- 7,a7 t has be5 manufactur$ or process$ = a nonexempt comm]cial purpose at any po9t dur+ ! #aj-ye> p]iod end+ on ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act2 7,b7 t is add$ to ! li/ publi%$ "u subsection 7b77#a7 aft] t date ( enactm5t2 or 7,c7 = :i* a notice is receiv$ "u subsection 7b77#e77;,c74 7#b7 ,inactive sub/ance ,! t]m inactive sub/ance means a *emical sub/ance on ! li/ publi%$ "u subsection 7b77#a7 t does n meet any ( ! crit]ia describ$ 9 p>agraph 7#a74 7#c7 ,manufacture2 process ,! 4 #aa4 ,relation%ip to o!r ,f$]al laws ,section #i ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjh7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 9 ! fir/ s5t5ce-- 7i7 by /rik+ pres5ts or w pres5t an unreasonable risk to heal? or ! environm5t & ins]t+ does n meet ! safety /&>d2 & 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+ section #f7;d7 or section #g2 & 7,c7 9 p>agraph 7#c71 by /rik+ section #f or #g & ins]t+ section #f7;d7 or #g2 7#b7 9 subsection 7d71 9 ! fir/ s5t5ce1 by /rik+ ,heal?1 ,education1 & ,welf>e & ins]t+ ,heal? & ,human ,s]vices2 & 7#c7 by add+ at ! end ! foll[+3 7e7 ,exposure in=mation ,if ! ,adm9i/rator obta9s in=mation relat$ to exposures or releases ( a *emical sub/ance t may be prev5t$ or r$uc$ "u ano!r ,f$]al law1 includ+ laws n adm9i/]$ by ! ,adm9i/rator1 ! ,adm9i/rator %all make su* in=mation available to ! relevant ,f$]al ag5cy or (fice ( ! ,environm5tal ,protection ,ag5cy4 4 #ab4 ,rese>*1 developm5t1 collection1 dissem9ation1 & utilization ( data ,section #aj ( ! ,toxic ,sub/ances ,control ,act 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 #ac4 ,exports ,section #ab ( ! ,toxic ,sub/ances ,control ,act 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 /&>d2 or 7,b7 "u section #f does n meet ! safety /&>d4 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 ! mixture or article2 or 7,b7 e/abli% a ?re%old conc5tration 9 a mixture or article at :i* p>agraph 7#a7 %all n apply4 7#d7 ,te/+ ,! ,adm9i/rator may require te/+ "u section #d ( any *emical sub/ance or mixture exempt$ f ?is ,act "u p>agraph 7#a7 = ! purpose ( det]m9+ :e!r ! *emical sub/ance or mixture meets ! safety /&>d )9 ! ,unit$ ,/ates4 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 & = :i* a prohibition or o!r re/riction has be5 propos$ or e/abli%$ "u t section2 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 & = :i* a prohibition or o!r re/riction has be5 propos$ or e/abli%$ "u t section2 7,c7 a *emical sub/ance = :i* ! ,unit$ ,/ates is obligat$ by treaty to provide export notification2 7,d7 a *emical sub/ance or mixture subject to a significant new use rule1 or a prohibition or o!r re/riction pursuant to a rule1 ord]1 or cons5t agreem5t 9 effect "u ?is ,act2 or 7,e7 a *emical sub/ance or mixture = :i* ! submission ( in=mation is requir$ "u section #d4 7#b7 ,rules 7,a7 ,9 g5]al ,! ,adm9i/rator %all promulgate rules to c>ry out p>agraph 7#a74 7,b7 ,cont5ts ,! rules promulgat$ pursuant to subp>agraph 7,a7 %all-- 7i7 include su* exemptions z ! ,adm9i/rator det]m9es to be appropriate1 :i* may include exemptions id5tifi$ "u section #e7;h72 & 7ii7 indicate :e!r1 or to :at ext5t1 ! rules 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,a71 7,b71 or 7,d7 ( p>agraph 7#a71 a notice ( ! det]m9ation1 rule1 ord]1 cons5t agreem5t1 requirem5t1 or designation2 7,b7 = a *emical sub/ance describ$ 9 p>agraph 7#a77;,c71 a notice t satisfies ! obligation ( ! ,unit$ ,/ates "u ! applicable treaty2 & 7,c7 = a *emical sub/ance or mixture describ$ 9 p>agraph 7#a77;,e71 a notice ( availability ( ! in=mation on ! *emical sub/ance or mixture submitt$ to ! ,adm9i/rator4 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 #ad4 ,confid5tial in=mation ,section #ad ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfac7 is am5d$ to read z foll[s3 #ad4 ,confid5tial in=mation 7a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 ! ,adm9i/rator %all n disclose in=mation t is exempt f disclosure pursuant to subsection 7a7 ( section #eeb ( title #e1 ,unit$ ,/ates ,code1 "u subsection 7b77#d7 ( t section-- 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 ,! foll[+ in=mation specific to1 & submitt$ by1 a manufactur]1 processor1 or di/ributor t meets ! requirem5ts ( subsections 7a7 & 7d7 %all be presum$ to be protect$ f disclosure1 subject to ! condition t no?+ 9 ?is ,act prohibits ! disclosure ( any su* in=mation1 or in=mation t is ! subject ( subsection 7g77#c71 ?r\gh discov]y1 subpo5a1 o!r c\rt ord]1 or any o!r judicial process o!rwise all[$ "u applicable ,f$]al or ,/ate law3 7#a7 ,specific in=mation describ+ ! processes us$ 9 manufacture or process+ ( a *emical sub/ance1 mixture1 or article4 7#b7 ,m>ket+ & sales in=mation4 7#c7 ,in=mation id5tify+ a suppli] or cu/om]4 7#d7 ,details ( ! full composition ( a mixture & ! respective p]c5tages ( con/itu5ts4 7#e7 ,specific in=mation reg>d+ ! use1 function1 or application ( a *emical sub/ance or mixture 9 a process1 mixture1 or product4 7#f7 ,specific production or import volumes ( ! manufactur] & specific aggregat$ volumes across manufactur]s1 if ! ,adm9i/rator det]m9es t disclosure ( ! specific aggregat$ volumes w\ld reveal confid5tial in=mation4 7#g7 ,except z o!rwise provid$ 9 ?is section1 ! specific id5tity ( a *emical sub/ance prior to ! date on :i* ! *emical sub/ance is fir/ (f]$ = comm]cial di/ribution1 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-- 7,a7 ! specific id5tity 0 claim$ z confid5tial in=mation at ! "t x 0 submitt$ 9 a notice "u section #e2 & 7,b7 ! claim-- 7i7 is n subject to an exception "u subsection 7e72 or 7ii7 has n subsequ5tly be5 )drawn or f\nd by ! ,adm9i/rator n to w>rant protection z confid5tial in=mation "u subsection 7f77#b7 or 7g74 7c7 ,in=mation n protect$ f disclosure ,not)/&+ subsections 7a7 & 7b71 ! foll[+ in=mation %all n be protect$ f disclosure3 7#a7 ,in=mation f heal? & safety /udies 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 subsection 7a7 does n prohibit ! disclosure (-- 7i7 any heal? & safety /udy t is submitt$ "u ?is ,act ) respect to-- 7,i7 any *emical sub/ance or mixture t1 on ! date on :i* ! /udy is to be disclos$1 has be5 (f]$ = comm]cial di/ribution2 or 7,,ii7 any *emical sub/ance or mixture = :i*-- 7aa7 te/+ is requir$ "u section #d2 or 7bb7 a notification is requir$ "u section #e2 or 7ii7 any in=mation report$ to1 or o!rwise obta9$ by1 ! ,adm9i/rator f a heal? & safety /udy relat+ to a *emical sub/ance or mixture describ$ 9 subclause 7,i7 or 7,,ii7 ( clause 7i74 7,b7 ,effect ( p>agraph ,no?+ 9 ?is p>agraph au?orizes ! release ( any in=mation t discloses-- 7i7 a process us$ 9 ! manufactur+ or process+ ( a *emical sub/ance or mixture2 or 7ii7 9 ! case ( a mixture1 ! portion ( ! mixture compris$ by any *emical sub/ance 9 ! mixture4 7#b7 ,c]ta9 reque/s ,if a reque/ is made to ! ,adm9i/rator "u section #eeb7;a7 ( title #e1 ,unit$ ,/ates ,code1 = in=mation t is describ$ 9 p>agraph 7#a7 t is n describ$ 9 p>agraph 7#a77;,b71 ! ,adm9i/rator may n d5y ! reque/ on ! basis ( section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7#c7 ,o!r in=mation n protect$ f disclosure ,! foll[+ in=mation is n protect$ f disclosure "u ?is section3 7,a7 ,= in=mation submitt$ aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! specific id5tity ( a *emical sub/ance z ( ! date on :i* ! *emical sub/ance is fir/ (f]$ = comm]cial di/ribution1 if ! p]son submitt+ ! in=mation does n meet ! requirem5ts ( subsection 7d74 7,b7 ,a safety assessm5t develop$1 or a safety det]m9ation made1 "u section #f4 7,c7 ,any g5]al in=mation describ+ ! manufactur+ volumes1 express$ z specific aggregat$ volumes or1 if ! ,adm9i/rator det]m9es t disclosure ( specific aggregat$ volumes w\ld reveal confid5tial in=mation1 express$ 9 ranges4 7,d7 ,a g5]al description ( a process us$ 9 ! manufacture or process+ & indu/rial1 comm]cial1 or consum] functions & uses ( a *emical sub/ance1 mixture1 or article conta9+ a *emical sub/ance or mixture1 includ+ in=mation specific to an indu/ry or indu/ry sector t cu/om>ily w\ld be %>$ ) ! g5]al public or )9 an indu/ry or indu/ry sector4 7#d7 ,mix$ confid5tial & nonconfid5tial in=mation ,any in=mation t is o!rwise eligible = protection "u ?is section & conta9$ 9 a submission ( in=mation describ$ 9 ?is subsection %all be protect$ f disclosure1 if ! submitt] complies ) subsection 7d71 subject to ! condition t in=mation 9 ! submission t is n eligible = protection aga9/ disclosure %all be disclos$4 7#e7 ,ban or phase-out ,if ! ,adm9i/rator promulgates a rule pursuant to section #f7;d7 t e/abli%es a ban or phase-out ( ! manufacture1 process+1 or di/ribution 9 comm]ce ( a *emical sub/ance1 subject to p>agraphs 7#b71 7#c71 & 7#d7 ( subsection 7g71 any protection f disclosure provid$ "u ?is section ) respect to ! specific id5tity ( ! *emical sub/ance & o!r in=mation relat+ to ! *emical sub/ance %all no long] apply4 7d7 ,requirem5ts = confid5tiality claims 7#a7 ,ass]tion ( claims 7,a7 ,9 g5]al ,a p]son seek+ to protect any in=mation submitt$ "u ?is ,act f disclosure 7includ+ in=mation describ$ 9 subsection 7b77 %all ass]t to ! ,adm9i/rator a claim = protection concurr5t ) submission ( ! in=mation1 9 accordance ) su* rules reg>d+ a claim = protection f disclosure z ! ,adm9i/rator has promulgat$ or may promulgate pursuant to ?is title4 7,b7 ,inclusion ,an ass]tion ( a claim "u subp>agraph 7,a7 %all include a /atem5t t ! p]son has-- 7i7 tak5 reasonable measures to protect ! confid5tiality ( ! in=mation2 7ii7 det]m9$ t ! in=mation is n requir$ to be disclos$ or o!rwise made available to ! public "u any o!r ,f$]al law2 7iii7 a reasonable basis to conclude t disclosure ( ! in=mation is likely to cause sub/antial h>m to ! competitive position ( ! p]son2 & 7iv7 a reasonable basis to believe t ! in=mation is n readily discov]able ?r\gh rev]se eng9e]+4 7,c7 ,specific *emical id5tity ,9 ! case ( a claim "u subp>agraph 7,a7 = protection aga9/ disclosure ( a specific *emical id5tity1 ! claim %all include a /ructurally descriptive g5]ic "n = ! *emical sub/ance t ! ,adm9i/rator may disclose to ! public1 subject to ! condition t ! g5]ic "n %all-- 7i7 con=m ) guidance prescrib$ by ! ,adm9i/rator "u p>agraph 7#c77;,a72 & 7ii7 describe ! *emical /ructure ( ! sub/ance z specifically z practicable :ile protect+ ^? features ( ! *emical /ructure-- 7,i7 t are consid]$ to be confid5tial2 & 7,,ii7 ! disclosure ( :i* w\ld be likely to h>m ! competitive position ( ! p]son4 7,d7 ,public in=mation ,no p]son may ass]t a claim "u ?is section = protection f disclosure ( in=mation t is already publicly available4 7#b7 ,additional requirem5ts = confid5tiality claims ,except = in=mation describ$ 9 p>agraphs 7#a7 ?r\gh 7#g7 ( subsection 7b71 a p]son ass]t+ a claim to protect in=mation f disclosure "u ?is ,act %all sub/antiate ! claim1 9 accordance ) ! rules promulgat$ & guidance issu$ by ! ,adm9i/rator4 7#c7 ,guidance ,! ,adm9i/rator %all develop guidance reg>d+-- 7,a7 ! det]m9ation ( /ructurally descriptive g5]ic names1 9 ! case ( claims = ! protection aga9/ disclosure ( specific *emical id5tity2 & 7,b7 ! cont5t & =m ( ! /atem5ts ( ne$ & agreem5ts requir$ "u p>agraphs 7#d71 7#e71 & 7#f7 ( subsection 7e74 7#d7 ,c]tification ,an au?oriz$ (ficial ( a p]son describ$ 9 p>agraph 7#a77;,a7 %all c]tify t ! in=mation t has be5 submitt$ is true & correct4 7e7 ,exceptions to protection f disclosure ,in=mation describ$ 9 subsection 7a7-- 7#a7 %all be disclos$ if ! in=mation is to be disclos$ to an (fic] or employee ( ! ,unit$ ,/ates 9 connection ) ! (ficial duties ( ! (fic] or employee-- 7,a7 "u any law = ! protection ( heal? or ! environm5t2 or 7,b7 = a specific law en=cem5t purpose2 7#b7 %all be disclos$ if ! in=mation is to be disclos$ to a contractor ( ! ,unit$ ,/ates & employees ( t contractor-- 7,a7 if1 9 ! op9ion ( ! ,adm9i/rator1 ! disclosure is necess>y = ! satisfactory p]=mance by ! contractor ( a contract ) ! ,unit$ ,/ates = ! p]=mance ( "w 9 connection ) ?is ,act2 & 7,b7 subject to su* conditions z ! ,adm9i/rator may specify2 7#c7 %all be disclos$ if ! ,adm9i/rator det]m9es t disclosure is necess>y to protect heal? or ! environm5t2 7#d7 %all be disclos$ if ! 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 #a or m applicable agreem5ts ) ! ,adm9i/rator t con=m ) ! guidance issu$ "u subsection 7d77#c77;,b7 ensure t ! recipi5t w take appropriate measures1 & has adequate au?ority1 to ma9ta9 ! confid5tiality ( ! in=mation 9 accordance ) proc$ures comp>able to ! proc$ures us$ by ! ,adm9i/rator to safegu>d ! in=mation2 & 7,b7 ! ,adm9i/rator notifies ! p]son t submitt$ ! in=mation t ! in=mation has be5 disclos$ to ! ,/ate or political subdivision ( a ,/ate2 7#e7 %all be disclos$ if a heal? or environm5tal 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$ & agrees to sign a writt5 confid5tiality agreem5t ) ! ,adm9i/rator1 subject to ! conditions t-- 7,a7 ! /atem5t ( ne$ & confid5tiality agreem5t %all con=m ) ! guidance issu$ "u subsection 7d77#c77;,b72 7,b7 ! writt5 /atem5t ( ne$ %all be a /atem5t t ! p]son has a reasonable basis to suspect t-- 7i7 ! in=mation is necess>y =1 or w assi/ 9-- 7,i7 ! diagnosis or treatm5t ( #a or m individuals2 or 7,,ii7 respond+ to an environm5tal release or exposure2 & 7ii7 #a or m individuals be+ diagnos$ or treat$ h be5 expos$ to ! *emical sub/ance conc]n$1 or an environm5tal release or exposure has occurr$2 & 7,c7 ! confid5tiality agreem5t %all provide t ! p]son w n use ! in=mation = any purpose o!r ?an ! heal? or environm5tal ne$s ass]t$ 9 ! /atem5t ( ne$1 except z o!rwise may be au?oriz$ by ! t]ms ( ! agreem5t or by ! p]son submitt+ ! in=mation to ! ,adm9i/rator1 except t no?+ 9 ?is ,act prohibits ! disclosure ( any su* in=mation ?r\gh discov]y1 subpo5a1 o!r c\rt ord]1 or any o!r judicial process o!rwise all[$ "u applicable ,f$]al or ,/ate law2 7#f7 %all be disclos$ if 9 ! ev5t ( an em]g5cy1 a treat+ physician1 nurse1 ag5t ( a poison control c5t]1 public heal? or environm5tal (ficial ( a ,/ate or political subdivision ( a ,/ate1 or fir/ respond] 7includ+ any individual duly au?oriz$ by a ,f$]al ag5cy1 ,/ate1 or political subdivision ( a ,/ate :o is tra9$ 9 urg5t m$ical c>e or o!r em]g5cy proc$ures1 includ+ a police (fic]1 firefight]1 or em]g5cy m$ical te*nician7 reque/s ! in=mation1 subject to ! conditions t-- 7,a7 ! treat+ physician1 nurse1 ag5t1 public heal? or environm5tal (ficial ( a ,/ate or a political subdivision ( a ,/ate1 or fir/ respond] %all h a reasonable basis to suspect t-- 7i7 a m$ical or public heal? or environm5tal em]g5cy exi/s2 7ii7 ! in=mation is necess>y =1 or w assi/ 91 em]g5cy or fir/-aid diagnosis or treatm5t2 or 7iii7 #a or m individuals be+ diagnos$ or treat$ h likely be5 expos$ to ! *emical sub/ance conc]n$1 or a s]i\s environm5tal release ( or exposure to ! *emical sub/ance conc]n$ has occurr$2 7,b7 if reque/$ by ! p]son submitt+ ! in=mation to ! ,adm9i/rator1 ! treat+ physician1 nurse1 ag5t1 public heal? or environm5tal (ficial ( a ,/ate or a political subdivision ( a ,/ate1 or fir/ respond] %all1 z describ$ 9 p>agraph 7#e7-- 7i7 provide a writt5 /atem5t ( ne$2 & 7ii7 agree to sign a confid5tiality agreem5t2 & 7,c7 ! writt5 confid5tiality agreem5t or /atem5t ( ne$ %all be submitt$ z soon z practicable1 b n necess>ily be=e ! in=mation is disclos$2 7#g7 may be disclos$ if ! ,adm9i/rator det]m9es t disclosure is relevant 9 a proce$+ "u ?is ,act1 subject to ! condition t ! disclosure %all be made 9 su* a mann] z to pres]ve confid5tiality to ! maximum ext5t practicable )\t impair+ ! proce$+2 7#h7 %all be disclos$ if ! in=mation is to be disclos$1 on writt5 reque/ ( any duly au?oriz$ congressional committee1 to t committee2 or 7#i7 %all be disclos$ if ! in=mation is requir$ to be disclos$ or o!rwise made public "u any o!r provision ( ,f$]al law4 7f7 ,duration ( protection f disclosure 7#a7 ,9 g5]al 7,a7 ,in=mation protect$ f disclosure ,subject to p>agraph 7#b71 ! ,adm9i/rator %all protect f disclosure in=mation t meets ! requirem5ts ( subsection 7d7 = a p]iod ( #aj ye>s1 unless1 prior to ! expiration ( ! p]iod-- 7i7 an affect$ p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7ii7 ! ,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 ,ext5sions 7i7 ,9 g5]al ,n lat] ?an ! date t is #fj days be=e ! expiration ( ! p]iod describ$ 9 subp>agraph 7,a71 ! ,adm9i/rator %all provide to ! p]son t ass]t$ ! claim a notice ( ! imp5d+ expiration ( ! p]iod4 7ii7 ,/atem5t 7,i7 ,9 g5]al ,n lat] ?an ! date t is #cj days be=e ! expiration ( ! p]iod describ$ 9 subp>agraph 7,a71 a p]son reass]t+ ! relevant claim %all submit to ! ,adm9i/rator a /atem5t sub/antiat+1 9 accordance ) subsection 7d77#b71 ! ne$ to ext5d ! p]iod4 7,,ii7 ,action by ,adm9i/rator ,n lat] ?an ! date t is #cj days aft] ! date ( receipt ( a /atem5t "u subclause 7,i71 ! ,adm9i/rator %all-- 7aa7 review ! reque/2 7bb7 make a det]m9ation reg>d+ :e!r ! in=mation = :i* ! reque/ is made cont9ues to meet ! relevant crit]ia e/abli%$ "u ?is section2 & 7cc7 7,,aa7 grant an ext5sion ( n m ?an #aj ye>s2 or 7,,bb7 d5y ! claim4 7,c7 ,no limit on numb] ( ext5sions ,!re %all be no limit on ! numb] ( ext5sions grant$ "u subp>agraph 7,b71 if ! ,adm9i/rator det]m9es t ! relevant /atem5t "u subp>agraph 7,b77ii77,i7-- 7i7 e/abli%es ! ne$ to ext5d ! p]iod2 & 7ii7 meets ! requirem5ts e/abli%$ by ! ,adm9i/rator4 7#b7 ,review & resub/antiation 7,a7 ,discretion ( ,adm9i/rator ,! ,adm9i/rator may review1 at any "t1 a claim = protection aga9/ disclosure "u subsection 7a7 = in=mation submitt$ to ! ,adm9i/rator reg>d+ a *emical sub/ance & require any p]son t has claim$ protection = t in=mation1 :e!r be=e1 on1 or aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 to )draw or reass]t & sub/antiate or resub/antiate ! claim 9 accordance ) ?is section-- 7i7 aft] ! *emical sub/ance is id5tifi$ z a high-priority sub/ance "u section #d;,a2 7ii7 = any *emical sub/ance = :i* ! ,adm9i/rator has made a det]m9ation "u section #f7;c77#a77;,c72 7iii7 = any inactive *emical sub/ance id5tifi$ "u section #h7;b77#e72 or 7iv7 9 limit$ circum/ances1 if ! ,adm9i/rator det]m9es t disclosure ( c]ta9 in=mation curr5tly protect$ f disclosure w\ld assi/ ! ,adm9i/rator 9 conduct+ safety assessm5ts & safety det]m9ations "u subsections 7b7 & 7c7 ( section #f or promulgat+ rules pursuant to section #f7;d71 subject to ! condition t ! in=mation %all n be disclos$ unless ! claimant )draws ! claim or ! ,adm9i/rator det]m9es t ! in=mation does n meet ! requirem5ts ( subsection 7d74 7,b7 ,review requir$ ,! ,adm9i/rator %all review a claim = protection f disclosure "u subsection 7a7 = in=mation submitt$ to ! ,adm9i/rator reg>d+ a *emical sub/ance & require any p]son t has claim$ protection = t in=mation1 :e!r be=e1 on1 or aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 to )draw or reass]t & sub/antiate or resub/antiate ! claim 9 accordance ) ?is section-- 7i7 z necess>y to comply ) a reque/ = in=mation receiv$ by ! ,adm9i/rator "u section #eeb ( title #e1 ,unit$ ,/ates ,code2 7ii7 if in=mation available to ! ,adm9i/rator provides a basis t ! requirem5ts ( section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 are no long] met2 or 7iii7 = any sub/ance = :i* ! ,adm9i/rator has made a det]m9ation "u section #f7;c77#a77;,b74 7,c7 ,action by recipi5t ,if ! ,adm9i/rator makes a reque/ "u subp>agraph 7,a7 or 7,b71 ! recipi5t ( ! reque/ %all-- 7i7 reass]t & sub/antiate or resub/antiate ! claim2 or 7ii7 )draw ! claim4 7,d7 ,p]iod ( protection ,protection f disclosure ( in=mation subject to a claim t is review$ & approv$ by ! ,adm9i/rator "u ?is p>agraph %all be ext5d$ = a p]iod ( #aj ye>s f ! date ( approval1 subject to any subsequ5t reque/ by ! ,adm9i/rator "u ?is p>agraph4 7#c7 ,unique id5tifi] ,! ,adm9i/rator %all-- 7,a7 7i7 develop a sy/em to assign a unique id5tifi] to ea* specific *emical id5tity = :i* ! ,adm9i/rator approves a reque/ = protection f disclosure1 o!r ?an a specific *emical id5tity or /ructurally descriptive g5]ic t]m2 & 7ii7 apply t id5tifi] consi/5tly to all in=mation relevant to ! applicable *emical sub/ance2 7,b7 annually publi% & update a li/ ( *emical sub/ances1 ref]r$ to by unique id5tifi]1 = :i* claims to protect ! specific *emical id5tity f disclosure h be5 approv$1 includ+ ! expiration date = ea* su* claim2 7,c7 ensure t any nonconfid5tial in=mation receiv$ by ! ,adm9i/rator ) respect to su* a *emical sub/ance dur+ ! p]iod ( protection f disclosure-- 7i7 is made public2 & 7ii7 id5tifies ! *emical sub/ance us+ ! unique id5tifi]2 & 7,d7 = ea* claim = protection ( specific *emical id5tity t has be5 d5i$ by ! ,adm9i/rator on expiration ( ! p]iod = appeal "u subsection 7g77#d71 t has expir$1 or t has be5 )drawn by ! submitt]1 provide public access to ! specific *emical id5tity cle>ly l9k$ to all nonconfid5tial in=mation receiv$ by ! ,adm9i/rator ) respect to ! *emical sub/ance4 7g7 ,duties ( ,adm9i/rator 7#a7 ,det]m9ation 7,a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 ! ,adm9i/rator %all1 subject to subp>agraph 7,c71 n lat] ?an #ij days aft] ! receipt ( a claim "u subsection 7d71 & n lat] ?an #cj days aft] ! receipt ( a reque/ = ext5sion ( a claim "u subsection 7f71 review & approve1 modify1 or d5y ! claim or reque/4 7,b7 ,d5ial or modification 7i7 ,9 g5]al ,except z provid$ 9 subsections 7c7 & 7f71 ! ,adm9i/rator %all d5y a claim to protect a *emical id5tity f disclosure only if ! p]son t has submitt$ ! claim fails to meet ! requirem5ts ( subsections 7a7 & 7d74 7ii7 ,reasons = d5ial or modification ,! ,adm9i/rator %all provide to a p]son t has submitt$ a claim describ$ 9 clause 7i7 a writt5 /atem5t ( ! reasons = ! d5ial or modification ( ! claim4 7,c7 ,subsets ,! ,adm9i/rator %all-- 7i7 except = claims describ$ 9 subsection 7b77#g71 review all claims "u ?is section = ! protection aga9/ disclosure ( ! specific id5tity ( a *emical sub/ance2 & 7ii7 review a repres5tative subset1 compris+ at lea/ #be p]c5t1 ( all o!r claims = protection aga9/ disclosure4 7,d7 ,effect ( failure to act ,! failure ( ! ,adm9i/rator to make a decision reg>d+ a claim = protection aga9/ disclosure or ext5sion "u ?is section %all n be ! basis = d5ial or elim9ation ( a claim = protection aga9/ disclosure4 7#b7 ,notification 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b7 & subsections 7c71 7e71 & 7f71 if ! ,adm9i/rator d5ies or modifies a claim "u p>agraph 7#a71 or promulgates a rule "u section #f7;d7 e/abli%+ a ban or phase-out ( a *emical sub/ance1 ! ,adm9i/rator %all notify1 9 writ+ & by c]tifi$ mail1 ! p]son t submitt$ ! claim ( ! int5t ( ! ,adm9i/rator to release ! in=mation4 7,b7 ,release ( in=mation 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 ! ,adm9i/rator %all n release in=mation "u ?is subsection until ! date t is #cj days aft] ! date on :i* ! p]son t 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 %all n release t in=mation until ! date t is #ae days aft] ! date on :i* ! p]son t submitt$ ! claim 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 heal? or ! environm5t1 9 :i* case no prior notification %all be necess>y4 7,,ii7 ,no notification ,= in=mation "u p>agraph 7#a71 7#b71 7#f71 7#g71 or 7#i7 ( subsection 7e71 no prior notification %all be necess>y4 7#c7 ,rebuttable presumption 7,a7 ,9 g5]al ,) respect to notifications provid$ by ! ,adm9i/rator pursuant to subsection 7c77#e71 !re %all be a rebuttable presumption t ! public int]e/ 9 disclos+ confid5tial in=mation relat$ to a *emical sub/ance subject to a rule promulgat$ "u section #f7;d7 t e/abli%es a ban or phase-out ( ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! sub/ance outweighs ! propriet>y int]e/ 9 ma9ta9+ ! protection f disclosure ( t in=mation4 7,b7 ,reque/ = nondisclosure ,a p]son t receives a notification "u p>agraph 7#b7 ) respect to ! in=mation describ$ 9 subp>agraph 7,a7 may submit to ! ,adm9i/rator1 be=e ! date on :i* ! in=mation is to be releas$1 a reque/ ) support+ docum5tation describ+ :y ! p]son believes "s or all ( t in=mation %\ld n be disclos$4 7,c7 ,det]m9ation by ,adm9i/rator 7i7 ,9 g5]al ,n lat] ?an #cj days aft] ! ,adm9i/rator receives a reque/ "u subp>agraph 7,b71 ! ,adm9i/rator %all det]m9e1 at ! discretion ( ! ,adm9i/rator1 :e!r ! docum5tation provid$ by ! p]son mak+ ! reque/ rebuts or does n rebut ! presumption describ$ 9 subp>agraph 7,a71 = all or a portion ( ! in=mation t ! p]son has reque/$ n be disclos$4 7ii7 ,objective ,! ,adm9i/rator %all make ! det]m9ation ) ! objective ( ensur+ t in=mation relevant to protection ( heal? & ! environm5t is disclos$ to ! maximum ext5t practicable4 7,d7 ,tim+ ,n lat] ?an #cj days aft] mak+ ! det]m9ation describ$ 9 subp>agraph 7,c71 ! ,adm9i/rator %all make public ! in=mation ! ,adm9i/rator has det]m9$ is n to be protect$ f disclosure4 7,e7 ,no timely reque/ receiv$ ,if ! ,adm9i/rator does n receive1 be=e ! date on :i* ! in=mation describ$ 9 subp>agraph 7,a7 is to be releas$1 a reque/ pursuant to subp>agraph 7,b71 ! ,adm9i/rator %all promptly make public all ( ! in=mation4 7#d7 ,appeals 7,a7 ,9 g5]al ,if a p]son receives a notification "u p>agraph 7#b7 & believes disclosure ( ! in=mation is prohibit$ "u subsection 7a71 be=e ! date on :i* ! in=mation is to be releas$1 ! p]son may br+ an action to re/ra9 disclosure ( ! in=mation 9-- 7i7 ! ,unit$ ,/ates di/rict c\rt ( ! di/rict 9 :i* ! compla9ant resides or has ! pr9cipal place ( bus9ess2 or 7ii7 ! ,unit$ ,/ates ,di/rict ,c\rt = ! ,di/rict ( ,columbia4 7,b7 ,no disclosure ,! ,adm9i/rator %all n disclose any in=mation t is ! subject ( an appeal "u ?is section be=e ! date on :i* ! applicable c\rt rules on an action "u subp>agraph 7,a74 7#e7 ,adm9i/ration ,9 c>ry+ out ?is subsection1 ! ,adm9i/rator %all use ! proc$ures describ$ 9 "p #b ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations74 7h7 ,crim9al p5alty = wrongful disclosure 7#a7 ,(fic]s & employees ( ,unit$ ,/ates 7,a7 ,9 g5]al ,subject to p>agraph 7#b71 a curr5t or =m] (fic] or employee ( ! ,unit$ ,/ates describ$ 9 subp>agraph 7,b7 %all be guilty ( a misdemeanor & f9$ "u title #ah1 ,unit$ ,/ates ,code1 or imprison$ = n m ?an #a ye>1 or bo?4 7,b7 ,description ,a curr5t or =m] (fic] or employee ( ! ,unit$ ,/ates ref]r$ to 9 subp>agraph 7,a7 is a curr5t or =m] (fic] or employee ( ! ,unit$ ,/ates :o-- 7i7 by virtue ( t employm5t or (ficial position has obta9$ possession (1 or has access to1 mat]ial ! disclosure ( :i* is prohibit$ by subsection 7a72 & 7ii7 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]ial4 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 t is provid$ in=mation 9 accordance ) subsection 7e77#b71 includ+ any employee ( t contractor1 %all be consid]$ to be an employee ( ! ,unit$ ,/ates4 7i7 ,applicability 7#a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 section #h1 or any o!r applicable ,f$]al law1 ! ,adm9i/rator %all h no au?ority-- 7,a7 to require ! sub/antiation or resub/antiation ( a claim = ! protection f disclosure ( in=mation submitt$ to ! ,adm9i/rator "u ?is ,act be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act2 or 7,b7 to impose sub/antiation or resub/antiation requirem5ts "u ?is ,act t are m ext5sive ?an ^? requir$ "u ?is section4 7#b7 ,prior actions ,no?+ 9 ?is ,act prev5ts ! ,adm9i/rator f review+1 requir+ sub/antiation or resub/antiation =1 or approv+1 modify+ or d5y+ any claim = ! protection f disclosure ( in=mation be=e ! effective date ( su* rules applicable to ^? claims z ! ,adm9i/rator may promulgate aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 4 #ae4 ,prohibit$ acts ,section #ae ( ! ,toxic ,sub/ances ,control ,act 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 "u section #e or #f2 7,c7 any rule promulgat$1 cons5t agreem5t ent]$ into1 or ord] issu$ "u section #e or #f2 or 7,d7 any requirem5t (1 or any rule promulgat$ or ord] issu$ pursuant to title ,,ii2 4 #af4 ,p5alties ,section #af ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfae7 is am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 9 ! fir/ s5t5ce-- 7i7 by ins]t+ ?is ,act or a rule or ord] promulgat$ or issu$ pursuant to ?is ,act1 includ+ aft] a provision (2 & 7ii7 by /rik+ #be1jjj & ins]t+ #cg1ejj2 & 7,b7 9 ! second s5t5ce1 by /rik+ violation ( section #ae or #dji & ins]t+ violation ( ?is ,act2 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ ,any p]son :o & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,any p]son t 2 7,b7 by /rik+ section #ae or #dji & ins]t+ ?is ,act2 7,c7 by /rik+ #be1jjj & ins]t+ #ej1jjj2 & 7,d7 by add+ at ! end ! foll[+3 7#b7 ,imm95t dang] ( dea? or s]i\s bodily injury 7,a7 ,9 g5]al ,any p]son t kn[+ly or willfully violates any provision ( ?is ,act1 & t kn[s at ! "t ( ! violation t ! violation places an individual 9 imm95t dang] ( dea? or s]i\s bodily injury1 %all be subject on conviction to a f9e ( n m ?an #bej1jjj1 or imprisonm5t = n m ?an #ae ye>s1 or bo?4 7,b7 ,organizations ,an organization t commits a violation describ$ 9 subp>agraph 7,a7 %all be subject on conviction to a f9e ( n m ?an #a1jjj1jjj = ea* violation4 7#c7 ,k ( imm95t dang] or injury ,= purposes ( det]m9+ :e!r a def5dant knew t ! violation plac$ ano!r individual 9 imm95t dang] ( dea? or s]i\s bodily injury-- 7,a7 ! def5dant %all be responsible only = actual aw>5ess or actual belief possess$2 & 7,b7 k possess$ by an individual may n be attribut$ to ! def5dant4 4 #ag4 ,/ate-,f$]al relation%ip ,section #ah ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfag7 is am5d$ by /rik+ subsections 7a7 & 7b7 & ins]t+ ! foll[+3 7a7 ,9 g5]al 7#a7 ,e/abli%m5t or en=cem5t ,except z provid$ 9 subsections 7c71 7d71 7e71 7f71 & 7g71 & subject to p>agraph 7#b71 no ,/ate or political subdivision ( a ,/ate may e/abli% or cont9ue to en=ce any ( ! foll[+3 7,a7 ,te/+ & in=mation collection ,a /atute or adm9i/rative action to require ! developm5t ( in=mation on a *emical sub/ance or category ( sub/ances t is reasonably likely to produce ! same in=mation requir$ "u section #d1 #e1 or #f 9-- 7i7 a rule promulgat$ by ! ,adm9i/rator2 7ii7 a te/+ cons5t agreem5t ent]$ into by ! ,adm9i/rator2 or 7iii7 an ord] issu$ by ! ,adm9i/rator4 7,b7 ,*emical sub/ances f\nd to meet ! safety /&>d or re/rict$ ,a /atute or adm9i/rative action to prohibit or o!rwise re/rict ! manufacture1 process+1 or di/ribution 9 comm]ce or use ( a *emical sub/ance-- 7i7 f\nd to meet ! safety /&>d & consi/5t ) ! scope ( ! det]m9ation made "u section #f2 or 7ii7 f\nd n to meet ! safety /&>d1 aft] ! effective date ( ! rule issu$ "u section #f7;d7 = ! sub/ance1 consi/5t ) ! scope ( ! det]m9ation made by ! ,adm9i/rator4 7,c7 ,significant new use ,a /atute or adm9i/rative action requir+ ! 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 7#b7 ,effective date ( preemption ,"u ?is subsection1 ,f$]al preemption ( ,/ate /atutes & adm9i/rative actions applicable to specific sub/ances %all n occur until ! effective date ( ! applicable action describ$ 9 p>agraph 7#a7 tak5 by ! ,adm9i/rator4 7b7 ,new /atutes or adm9i/rative actions creat+ prohibitions or o!r re/rictions 7#a7 ,9 g5]al ,except z provid$ 9 subsections 7c71 7d71 & 7e71 beg9n+ on ! date on :i* ! ,adm9i/rator def9es ! scope ( a safety assessm5t & safety det]m9ation "u section #f7;a77#b7 & end+ on ! date on :i* ! ,adm9i/rator publi%es ! safety det]m9ation1 no ,/ate or political subdivision ( a ,/ate may e/abli% a /atute or adm9i/rative action prohibit+ or re/rict+ ! manufacture1 process+1 di/ribution 9 comm]ce or use ( a *emical sub/ance t is a high-priority sub/ance designat$ "u section #d;,a4 7#b7 ,effect ( subsection 7,a7 ,9 g5]al ,?is subsection does n re/rict ! au?ority ( a ,/ate or political subdivision ( a ,/ate to cont9ue to en=ce any ,/ate /atute enact$1 or adm9i/rative action tak51 prior to ! date on :i* ! ,adm9i/rator def9es ! scope ( a safety assessm5t & safety det]m9ation "u section #f7;a77#b74 7,b7 ,limitation ,subp>agraph 7,a7 does n all[ a ,/ate or political subdivision ( a ,/ate to en=ce any new prohibition or re/riction "u a ,/ate /atute or adm9i/rative action describ$ 9 t subp>agraph1 if ! prohibition or re/riction is e/abli%$ aft] ! date describ$ 9 t subp>agraph4 7c7 ,scope ( preemption ,f$]al preemption "u subsections 7a7 & 7b7 ( ,/ate /atutes & adm9i/rative actions applicable to specific sub/ances %all apply only to-- 7#a7 ! *emical sub/ances or category ( sub/ances subject to a rule1 ord]1 or cons5t agreem5t "u section #d2 7#b7 ! uses or conditions ( use ( su* sub/ances t are id5tifi$ by ! ,adm9i/rator z subject to review 9 a safety assessm5t & includ$ 9 ! scope ( ! safety det]m9ation made by ! ,adm9i/rator = ! sub/ance1 or ( any rule ! ,adm9i/rator promulgates pursuant to section #f7;d72 or 7#c7 ! uses ( su* sub/ances t ! ,adm9i/rator has specifi$ z significant new uses & = :i* ! ,adm9i/rator has requir$ notification pursuant to a rule promulgat$ "u section #e4 7d7 ,exceptions 7#a7 ,no preemption ( ,/ate /atutes & adm9i/rative actions 7,a7 ,9 g5]al ,no?+ 9 ?is ,act1 nor any am5dm5t made by ?is ,act1 nor any rule1 /&>d ( p]=mance1 safety det]m9ation1 or sci5tific assessm5t implem5t$ pursuant to ?is ,act1 %all affect ! "r ( a ,/ate or a political subdivision ( a ,/ate to adopt or en=ce any rule1 /&>d ( p]=mance1 safety det]m9ation1 sci5tific assessm5t1 or any protection = public heal? or ! environm5t t-- 7i7 is adopt$ or au?oriz$ "u ! au?ority ( any o!r ,f$]al law or adopt$ to satisfy or obta9 au?orization or approval "u any o!r ,f$]al law2 7ii7 implem5ts a report+1 monitor+1 disclosure1 or o!r in=mation obligation = ! *emical sub/ance n o!rwise requir$ by ! ,adm9i/rator "u ?is ,act or requir$ "u any o!r ,f$]al law2 7iii7 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 disposal1 except to ! ext5t t ! action-- 7,i7 imposes a re/riction on ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance2 & 7,,ii7 7aa7 addresses ! same haz>ds & exposures1 ) respect to ! same conditions ( use z are includ$ 9 ! scope ( ! safety det]m9ation pursuant to section #f1 b is inconsi/5t ) ! action ( ! ,adm9i/rator2 or 7bb7 w\ld cause a violation ( ! applicable action by ! ,adm9i/rator "u section #e or #f2 or 7iv7 subject to subp>agraph 7,b71 is id5tical to a requirem5t prescrib$ by ! ,adm9i/rator4 7,b7 ,id5tical requirem5ts 7i7 ,9 g5]al ,! p5alties & o!r sanctions applicable "u ,/ate law 9 ! ev5t ( noncompliance ) ! id5tical requirem5t %all be no m /r+5t ?an ! p5alties & o!r sanctions available to ! ,adm9i/rator "u section #af ( ?is ,act4 7ii7 ,p5alties ,9 ! case ( an id5tical requirem5t1 no ,/ate may assess a p5alty = a specific violation = :i* ! ,adm9i/rator has already assess$ a p5alty "u section #af1 & ! ,adm9i/rator may n assess a p5alty "u section #af = a specific violation = :i* a ,/ate has already assess$ a p5alty4 7#b7 ,applicability to c]ta9 rules or ord]s ,not)/&+ subsection 7e7-- 7,a7 no?+ 9 ?is section %all be con/ru$ z modify+ ! effect "u ?is section1 z 9 effect on ! day be=e ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ( any rule or ord] promulgat$ or issu$ "u ?is ,act prior to t effective date2 & 7,b7 ) respect to a *emical sub/ance or mixture = :i* any rule or ord] 0 promulgat$ or issu$ "u section #f prior to ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act ) reg>ds to manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance1 ?is section 7z 9 effect on ! day be=e ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act7 %all gov]n ! preemptive effect ( any rule or ord] t is promulgat$ or issu$ respect+ su* *emical sub/ance or mixture "u section #f ( ?is ,act aft] t effective date1 unless ! latt] rule or ord] is ) respect to a *emical sub/ance or mixture conta9+ a *emical sub/ance & foll[s a designation ( t *emical sub/ance z a high-priority sub/ance "u section #d;,a7b7 or z an additional priority = safety assessm5t & safety det]m9ation "u section #d;,a7c74 7e7 ,pres]vation ( c]ta9 ,/ate law 7#a7 ,9 g5]al ,no?+ 9 ?is ,act1 subject to subsection 7g7 ( ?is section1 %all-- 7,a7 be con/ru$ to preempt or o!rwise affect ! au?ority ( a ,/ate or political subdivision ( a ,/ate to cont9ue to en=ce any action tak5 be=e ,augu/ #a1 #bjae1 "u ! au?ority ( a ,/ate law t prohibits or o!rwise re/ricts manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance2 or 7,b7 be con/ru$ to preempt or o!rwise affect any action tak5 pursuant to a ,/ate law t 0 9 effect on ,augu/ #ca1 #bjjc4 7#b7 ,effect ( subsection ,?is subsection does n affect1 modify1 or alt] ! relation%ip betwe5 ,/ate & ,f$]al law pursuant to any o!r ,f$]al law4 7f7 ,/ate waiv]s 7#a7 ,discretion>y exemptions ,^u application ( a ,/ate or political subdivision ( a ,/ate1 ! ,adm9i/rator may by rule1 exempt f subsection 7a71 "u su* conditions z may be prescrib$ 9 ! rule1 a /atute or adm9i/rative action ( t ,/ate or political subdivision ( ! ,/ate t relates to ! effects (1 or exposure to1 a *emical sub/ance "u ! conditions ( use if ! ,adm9i/rator det]m9es t-- 7,a7 compell+ ,/ate or local conditions w>rant grant+ ! waiv] to protect heal? or ! environm5t2 7,b7 compliance ) ! propos$ requirem5t ( ! ,/ate or political subdivision ( ! ,/ate w\ld n unduly burd5 int]/ate comm]ce 9 ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance2 7,c7 compliance ) ! propos$ requirem5t ( ! ,/ate or political subdivision ( ! ,/ate w\ld n cause a violation ( any applicable ,f$]al law1 rule1 or ord]2 & 7,d7 bas$ on ! judgm5t ( ! ,adm9i/rator1 ! propos$ requirem5t ( ! ,/ate or political subdivision ( ! ,/ate is consi/5t ) s\nd objective sci5tific practices1 ! weight ( ! evid5ce1 & ! be/ available sci5ce4 7#b7 ,requir$ exemptions ,^u application ( a ,/ate or political subdivision ( a ,/ate1 ! ,adm9i/rator %all exempt f subsection 7b7 a /atute or adm9i/rative action ( a ,/ate or political subdivision ( a ,/ate t relates to ! effects ( exposure to a *emical sub/ance "u ! conditions ( use if ! ,adm9i/rator det]m9es t-- 7,a7 compliance ) ! propos$ requirem5t ( ! ,/ate w n unduly burd5 int]/ate comm]ce 9 ! manufacture1 process+1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance2 7,b7 compliance ) ! propos$ requirem5t w\ld n cause a violation ( any applicable ,f$]al law1 rule1 or ord]2 & 7,c7 ! ,/ate or political subdivision ( a ,/ate has a conc]n ab\t ! *emical sub/ance or use ( ! *emical sub/ance bas$ 9 pe]-review$ sci5ce4 7#c7 ,det]m9ation ( a ,/ate waiv] reque/ ,! duty ( ! ,adm9i/rator to grant or d5y a waiv] application %all be nondelegable & %all be ex]cis$-- 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 ,failure to make det]m9ation ,if ! ,adm9i/rator fails to make a det]m9ation "u p>agraph 7#c77;,b7 dur+ ! #ij-;day p]iod beg9n+ on ! date on :i* an application "u p>agraph 7#b7 is submitt$1 ! ,/ate /atute or adm9i/rative action t 0 ! subject ( ! application %all n be consid]$ to be an exi/+ /atute or adm9i/rative action = purposes ( subsection 7b7 by reason ( ! failure ( ! ,adm9i/rator to make a det]m9ation4 7#e7 ,notice & comm5t ,except 9 ! case ( an application approv$ "u p>agraph 7#i71 ! application ( a ,/ate or political subdivision ( ! ,/ate %all be subject to public notice & comm5t4 7#f7 ,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#g7 ,duration ( waiv]s 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 a waiv] grant$ "u p>agraph 7#b7 or approv$ "u p>agraph 7#i7 %all rema9 9 effect-- 7i7 until su* "t z ! safety assessm5t & safety det]m9ation is complet$2 or 7ii7 subject to subp>agraph 7,b71 until judicial review ( ! failure ( ! ,adm9i/rator to make a det]m9ation "u p>agraph 7#c7 is s\ght "u p>agraph 7#h74 7,b7 ,re9/atem5t ( waiv] ,a waiv] describ$ 9 subp>agraph 7,a77ii7 %all aga9 take effect ^u ! e>li] (-- 7i7 ! date ( approval by ! ,adm9i/rator ( ! waiv] application2 7ii7 ! effective date ( a c\rt ord] direct+ ! ,adm9i/rator to approve ! waiv] application2 or 7iii7 #ij days aft] ! date on :i* judicial review "u p>agraph 7#h7 is s\ght4 7#h7 ,judicial review ( waiv]s ,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#a7 or 7#b71 or n lat] ?an #fj days aft] ! date on :i* ! ,adm9i/rator fails to make a det]m9ation "u p>agraph 7#c71 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 7#i7 ,approval 7,a7 ,9 g5]al ,if ! ,adm9i/rator fails to meet ! deadl9e "u section #f7;a77#d7 7includ+ an ext5sion grant$ "u section #f7;a77#f771 or ! deadl9e e/abli%$ "u p>agraph 7#c77;,b71 ! application ( a ,/ate or political subdivision ( a ,/ate "u p>agraph 7#b7 %all be automatically approv$4 7,b7 ,requirem5ts ,not)/&+ p>agraph 7#f71 approval ( a waiv] application "u subp>agraph 7,a7 = failure to meet ! deadl9es "u section #f7;a77#d7 7includ+ an ext5sion grant$ "u section #f7;a77#f77 %all n be consid]$ f9al ag5cy action or be subject to judicial review or public notice & comm5t4 7#aj7 ,judicial review ( l[-priority decisions 7,a7 ,9 g5]al ,n lat] ?an #fj days aft] ! publication ( a designation "u section #d;,a7b77#d71 any p]son may comm5ce a civil action to *all5ge ! designation4 7,b7 ,jurisdiction ,! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit %all h exclusive jurisdiction ov] a civil action fil$ "u ?is p>agraph4 7g7 ,sav+s 7#a7 ,no preemption ( common law or /atutory causes ( action = civil relief or crim9al conduct 7,a7 ,9 g5]al ,no?+ 9 ?is ,act1 nor any am5dm5t made by ?is ,act1 nor any safety /&>d1 rule1 requirem5t1 /&>d ( p]=mance1 safety det]m9ation1 or sci5tific assessm5t implem5t$ pursuant to ?is ,act1 %all be con/ru$ to preempt1 displace1 or supplant any /ate or ,f$]al common law rights or any /ate or ,f$]al /atute creat+ a rem$y = civil relief1 includ+ ^? = civil damage1 or a p5alty = a crim9al conduct4 7,b7 ,cl>ification ( no preemption ,not)/&+ any o!r provision ( ?is ,act1 no?+ 9 ?is ,act1 nor any am5dm5ts made by ?is ,act1 %all preempt or preclude any cause ( action = p]sonal injury1 wrongful dea?1 prop]ty damage1 or o!r injury bas$ on neglig5ce1 /rict liability1 products liability1 failure to w>n1 or any o!r legal !ory ( liability "u any ,/ate law1 m>itime law1 or ,f$]al common law or /atutory !ory4 7#b7 ,no effect on private rem$ies 7,a7 ,9 g5]al ,no?+ 9 ?is ,act1 nor any am5dm5ts made by ?is ,act1 nor any rules1 regulations1 requirem5ts1 safety assessm5ts1 safety det]m9ations1 sci5tific assessm5ts1 or ord]s issu$ pursuant to ?is ,act %all be int]pret$ z1 9 ei!r ! pla9tiff's or def5dant's favor1 dispositive 9 any civil action4 7,b7 ,au?ority ( c\rts ,?is ,act does n affect ! au?ority ( any c\rt to make a det]m9ation 9 an adjudicatory proce$+ "u applicable ,/ate or ,f$]al law ) respect to ! admission into evid5ce or any o!r use ( ?is ,act or rules1 regulations1 requirem5ts1 /&>ds ( p]=mance1 safety assessm5ts1 sci5tific assessm5ts1 or ord]s issu$ pursuant to ?is ,act4 4 #ah4 ,judicial review ,section #ai ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfah7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,a71 by /rik+ section #d7;a71 #e7;a77#b71 #e7;b77#d71 #f7;a71 #f7;e71 or #h1 or "u title ,,ii or ,,iv & ins]t+ section #d7;a71 #e7;d71 #f7;c71 #f7;d71 #f7;g71 or #h1 or title ,,ii or ,,iv2 & 7ii7 9 subp>agraph 7,b71 by /rik+ an ord] issu$ "u subp>agraph 7,a7 or 7,b7 ( section #f7;b77#a7 & ins]t+ an ord] issu$ "u ?is title2 & 7,b7 9 p>agraph 7#b71 9 ! fir/ s5t5ce1 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#a77;,b7-- 7,a7 9 clause 7i7-- 7i7 by /rik+ section #d7;a71 #e7;b77#d71 #f7;a71 or #f7;e7 & ins]t+ section #d7;a71 #e7;d71 #f7;d71 or #f7;g72 & 7ii7 by /rik+ evid5ce 9 ! rulemak+ record 7z def9$ 9 subsection 7a77#c77 tak5 z a :ole2 & ins]t+ evid5ce 7includ+ any matt]7 9 ! rulemak+ record1 tak5 z a :ole2 &2 & 7,b7 by /rik+ clauses 7ii7 & 7iii7 & ! matt] foll[+ clause 7iii7 & ins]t+ ! foll[+3 7ii7 ! c\rt may n review ! cont5ts & adequacy ( any /atem5t ( basis & purpose requir$ by section #eec7;c7 ( title #e1 ,unit$ ,/ates ,code1 to be incorporat$ 9 ! rule1 except z "p ( ! rulemak+ record1 tak5 z a :ole4 4 #ai4 ,citiz5s' petitions ,section #ba ( ! ,toxic ,sub/ances ,control ,act 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 #d or #e7;d72 & 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 #d or #e7;d72 & 7,b7 9 p>agraph 7#d71 by /rik+ subp>agraph 7,b7 & 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 promulgate a rule pursuant to section #d1 #e1 #f1 or #h or issue an ord] "u section #d or #e7;d71 ! 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 9 a de novo proce$+ "u ?is subp>agraph %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 #d1 ! in=mation available to ! ,adm9i/rator is insuffici5t = ! ,adm9i/rator to p]=m an action describ$ 9 section #d1 #d;,a1 #e1 or #f7;d72 7bb7 9 ! case ( a petition to issue an ord] "u section #e7;d71 !re is a reasonable basis to conclude t ! *emical sub/ance is n likely to meet ! safety /&>d2 7cc7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #f7;d71 !re is a reasonable basis to conclude t ! *emical sub/ance w n meet ! safety /&>d2 or 7dd7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #h1 !re is a reasonable basis to conclude t ! rule is necess>y to protect heal? or ! environm5t or ensure t ! *emical sub/ance meets ! safety /&>d4 7,,ii7 ,def]m5t ,! c\rt 9 a de novo proce$+ "u ?is subp>agraph may p]mit ! ,adm9i/rator to def] initiat+ ! action reque/$ by ! petition] until su* "t z ! c\rt prescribes1 if ! c\rt f9ds t-- 7aa7 ! ext5t ( ! risk to heal? or ! environm5t alleg$ by ! petition] is less ?an ! ext5t ( risks to 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 #bj4 ,employm5t effects ,section #bd7;b77#b77;,b77ii7 ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbc7;b77#b77;,b77ii77 is am5d$ by /rik+ section #f7;c77#c71 & ins]t+ ! applicable requirem5ts ( ?is ,act24 #ba4 ,/udies ,section #be ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbd7 is repeal$4 #bb4 ,adm9i/ration ,section #bf ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbe7 is am5d$-- 7#a7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,fees 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli%1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 by rule-- 7,a7 ! paym5t ( #a or m reasonable fees z a condition ( submitt+ a notice or reque/+ an exemption "u section #e2 7,b7 ! paym5t ( #a or m reasonable fees by a manufactur] or processor t-- 7i7 is requir$ to submit a notice pursuant to ! rule promulgat$ "u section #h7;b77#d77;,a77i7 id5tify+ a *emical sub/ance z active2 7ii7 is requir$ to submit a notice pursuant to section #h7;b77#e77;,b77i7 *ang+ ! /atus ( a *emical sub/ance f inactive to active2 7iii7 is requir$ to report in=mation pursuant to ! rules promulgat$ "u section #h7;a77#d72 & 7iv7 manufactures or processes a *emical sub/ance subject to a safety assessm5t & safety det]m9ation pursuant to section #f4 7#b7 ,utilization & collection ( fees ,! ,adm9i/rator %all-- 7,a7 utilize ! fees collect$ "u p>agraph 7#a7 only to defray co/s associat$ ) ! actions ( ! ,adm9i/rator-- 7i7 to collect1 process1 review1 provide access to1 & protect f disclosure 7:]e appropriate7 in=mation on *emical sub/ances "u ?is ,act2 7ii7 to review notices & make det]m9ations = *emical sub/ances "u p>agraphs 7#a7 & 7#c7 ( section #e7;d7 & impose any necess>y re/rictions "u section #e7;d77#d72 7iii7 to make prioritization decisions "u section #d;,a2 7iv7 to conduct & complete safety assessm5ts & det]m9ations "u section #f2 & 7v7 to conduct any necess>y rulemak+ pursuant to section #f7;d72 7,b7 ins(> z possible1 collect ! fees describ$ 9 p>agraph 7#a7 9 advance ( conduct+ any fee-support$ activity2 7,c7 deposit ! fees 9 ! ,fund e/abli%$ by p>agraph 7#d77;,a72 & 7,d7 n collect excess fees or reta9 a significant am\nt ( unus$ fees4 7#c7 ,am\nt & adju/m5t ( fees2 refunds ,9 sett+ fees "u ?is section1 ! ,adm9i/rator %all-- 7,a7 take into acc\nt ! co/ to ! ,adm9i/rator ( conduct+ ! activities describ$ 9 p>agraph 7#b72 7,b7 prescribe l[] fees = small bus9ess conc]ns1 aft] consultation ) ! ,adm9i/rator ( ! ,small ,bus9ess ,adm9i/ration2 7,c7 set ! fees e/abli%$ "u p>agraph 7#a7 at levels su* t ! fees w1 9 aggregate1 provide a su/a9able s\rce ( funds to defray approximately #be p]c5t ( ! co/s ( conduct+ ! activities id5tifi$ 9 p>agraph 7#b77;,a71 n to exce$ #ah1jjj1jjj1 n includ+ fees "u subp>agraph 7,e7 ( ?is p>agraph2 7,d7 reflect an appropriate balance 9 ! assessm5t ( fees betwe5 manufactur]s & processors1 & all[ ! paym5t ( fees by consortia ( manufactur]s or processors2 7,e7 = sub/ances designat$ z additional priorities pursuant to section #d;,a7c71 e/abli% ! fee at a level suffici5t to defray ! full co/s to ! ,adm9i/rator ( conduct+ ! safety assessm5t & safety det]m9ation "u section #f1 except t = sub/ances subject to section #d;,a7c77#c71 ! ,adm9i/rator %all e/abli% ! fee at a level suffici5t to defray #ej p]c5t ( ^? co/s2 7,f7 prior to ! e/abli%m5t or am5dm5t ( any fees "u p>agraph 7#a71 consult & meet ) p>ties pot5tially subject to ! fees or _! repres5tatives1 subject to ! condition t no obligation "u ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 or sub*apt] ,,iii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 is applicable ) respect to su* meet+s2 7,g7 beg9n+ ) ! fiscal ye> t is #c ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 & e #c ye>s !reaft]1 aft] consultation ) p>ties pot5tially subject to ! fees & _! repres5tatives1 increase or decrease ! fees e/abli%$ "u p>agraph 7#a7 z necess>y-- 7i7 to ensure t funds deposit$ 9 ! ,fund are suffici5t to conduct ! activities id5tifi$ 9 p>agraph 7#b77;,a7 & ! full co/ or #ej-p]c5t portion ( ! co/s ( safety assessm5ts & safety det]m9ations pursuant to subp>agraph 7,e72 & 7ii7 to acc\nt = inflation2 7,h7 adju/ fees e/abli%$ "u p>agraph 7#a7 z necess>y to v>y on acc\nt ( diff]+ circum/ances1 includ+ r$uc$ fees or waiv]s 9 appropriate circum/ances1 to r$uce ! burd5 on manufactur+ or process+1 remove b>ri]s to innovation1 or :]e ! co/s to ! ,adm9i/rator ( collect+ ! fees exce$ ! fee rev5ue anticipat$ to be collect$2 & 7,i7 if a notice submitt$ "u section #e is refus$ or subsequ5tly )drawn1 refund ! fee or a portion ( ! fee if no sub/antial "w 0 p]=m$ on ! notice4 7#d7 ,,tsca ,implem5tation ,fund 7,a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates a fund1 to be kn[n z ! ,,tsca ,implem5tation ,fund 7ref]r$ to 9 ?is subsection z ! ,fund71 consi/+ (-- 7i7 su* am\nts z are deposit$ 9 ! ,fund "u p>agraph 7#b77;,c72 & 7ii7 any int]e/ e>n$ on ! inve/m5t ( am\nts 9 ! ,fund2 & 7iii7 any proce$s f ! sale or r$emption ( inve/m5ts held 9 ! ,fund4 7,b7 ,cr$it+ & availability ( fees 7i7 ,9 g5]al ,fees au?oriz$ "u ?is section %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriations ,acts1 & %all be available )\t fiscal ye> limitation4 7ii7 ,requirem5ts ,fees collect$ "u ?is section %all n-- 7,i7 be made available or obligat$ = any purpose o!r ?an to defray ! co/s ( conduct+ ! activities id5tifi$ 9 p>agraph 7#b77;,a72 7,,ii7 o!rwise be available = any purpose o!r ?an implem5tation ( ?is ,act2 & 7,,iii7 s long z am\nts 9 ! ,fund rema9 available1 be subject to re/rictions on exp5ditures applicable to ! ,f$]al gov]nm5t z a :ole4 7,c7 ,unus$ funds ,am\nts 9 ! ,fund n curr5tly ne$$ to c>ry out ?is subsection %all be-- 7i7 ma9ta9$ readily available or on deposit2 7ii7 inve/$ 9 obligations ( ! ,unit$ ,/ates or gu>ante$ by ! ,unit$ ,/ates2 or 7iii7 inve/$ 9 obligations1 p>ticipations1 or o!r in/rum5ts t are lawful inve/m5ts = fiduci>y1 tru/1 or public funds4 7,d7 ,m9imum am\nt ( appropriations ,fees may n be assess$ = a fiscal ye> "u ?is section unless ! am\nt ( appropriations = sal>ies1 contracts1 & exp5ses = ! functions 7z 9 exi/5ce 9 fiscal ye> #bjae7 ( ! ,(fice ( ,pollution ,prev5tion & ,toxics ( ! ,environm5tal ,protection ,ag5cy = ! fiscal ye> 7exclud+ ! am\nt ( any fees appropriat$ = ! fiscal ye>7 are equal to or great] ?an ! am\nt ( appropriations = cov]$ functions = fiscal ye> #bjae 7exclud+ ! am\nt ( any fees appropriat$ = ! fiscal ye>74 7#e7 ,audit+ 7,a7 ,f9ancial /atem5ts ( ag5cies ,= ! purpose ( section #ceae7;c7 ( title #ca1 ,unit$ ,/ates ,code1 ! ,fund %all be consid]$ a compon5t ( an executive ag5cy4 7,b7 ,compon5ts ,! annual audit requir$ "u sections #ceae7;b7 & #ceba ( t title ( ! f9ancial /atem5ts ( activities "u ?is subsection %all include an analysis (-- 7i7 ! fees collect$ "u p>agraph 7#a7 & disburs$2 7ii7 compliance ) ! deadl9es e/abli%$ 9 section #f ( ?is ,act2 7iii7 ! am\nts budget$1 appropriat$1 collect$ f fees1 & disburs$ to meet ! requirem5ts ( sections #d1 #d;,a1 #e1 #f1 #h1 & #ad1 includ+ ! allocation ( full "t equival5t employees to ea* su* section or activity2 & 7iv7 ! reasonabl5ess ( ! allocation ( ! ov]head associat$ ) ! conduct ( ! activities describ$ 9 p>agraph 7#b77;,a74 7,c7 ,inspector ,g5]al ,! ,inspector ,g5]al ( ! ,environm5tal ,protection ,ag5cy %all-- 7i7 conduct ! annual audit requir$ "u ?is subsection2 & 7ii7 report ! f9d+s & recomm5dations ( ! audit to ! ,adm9i/rator & to ! appropriate committees ( ,congress4 7#f7 ,t]m9ation ,! au?ority provid$ by ?is section %all t]m9ate at ! conclusion ( ! fiscal ye> t is #aj ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 unless o!rwise reau?oriz$ or modifi$ by ,congress4 2 7#b7 9 subsection 7e71 by /rik+ ,heal?1 ,education1 & ,welf>e ea* place x appe>s & ins]t+ ,heal? & ,human ,s]vices2 & 7#c7 add+ at ! end ! foll[+3 7h7 ,prior actions ,no?+ 9 ?is ,act elim9ates1 modifies1 or )draws any rule promulgat$1 ord] issu$1 or exemption e/abli%$ pursuant to ?is ,act be=e ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 4 #bc4 ,developm5t & evaluation ( te/ me?ods & su/a9able *emi/ry ,section #bg ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbf7 is am5d$-- 7#a7 9 subsection 7a71 9 ! fir/ s5t5ce by /rik+ ,heal?1 ,education1 & ,welf>e & ins]t+ ,heal? & ,human ,s]vices2 & 7#b7 by add+ at ! end ! foll[+3 7c7 ,su/a9able ,*emi/ry ,program ,! ,presid5t %all e/abli% an int]ag5cy ,su/a9able ,*emi/ry ,program to promote & coord9ate ,f$]al su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 te*nology transf]1 comm]cialization1 education1 & tra9+ activities4 7d7 ,program activities ,! activities ( ! ,program %all be design$ to-- 7#a7 provide su/a9$ support = su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 te*nology transf]1 comm]cialization1 education1 & tra9+ ?r\gh-- 7,a7 coord9ation ( su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 & te*nology transf] conduct$ at ,f$]al laboratories & ag5cies2 & 7,b7 to ! ext5t practicable1 enc\ragem5t ( consid]ation ( su/a9able *emi/ry 91 z appropriate-- 7i7 ! conduct ( ,f$]al & ,/ate sci5ce & eng9e]+ rese>* & developm5t2 & 7ii7 ! solicitation & evaluation ( applicable proposals = sci5ce & eng9e]+ rese>* & developm5t2 7#b7 exam9e me?ods by :i* ! ,f$]al ,gov]nm5t c create inc5tives = consid]ation & use ( su/a9able *emi/ry processes & products1 includ+ innovative f9anc+ me*anisms2 7#c7 exp& ! education & tra9+ ( und]graduate & graduate /ud5ts & pr(essional sci5ti/s & eng9e]s1 includ+ ?r\gh p>tn]%ips ) indu/ry1 9 su/a9able *emi/ry sci5ce & eng9e]+2 7#d7 collect & dissem9ate in=mation on su/a9able *emi/ry rese>*1 developm5t1 & te*nology transf] includ+ in=mation on-- 7,a7 inc5tives & imp$im5ts to developm5t1 manufactur+1 & comm]cialization2 7,b7 accompli%m5ts2 7,c7 be/ practices2 & 7,d7 co/s & b5efits2 7#e7 support 7includ+ ?r\gh te*nical assi/ance1 p>ticipation1 f9ancial support1 or o!r =ms ( support7 economic1 legal1 & o!r appropriate social sci5ce rese>* to id5tify b>ri]s to comm]cialization & me?ods to advance comm]cialization ( su/a9able *emi/ry4 7e7 ,int]ag5cy work+ gr\p 7#a7 ,e/abli%m5t ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,presid5t1 9 consultation ) ! ,(fice ( ,sci5ce & ,te*nology ,policy1 %all e/abli% an ,int]ag5cy ,work+ ,gr\p t %all include repres5tatives f ! ,national ,sci5ce ,f\ndation1 ! ,national ,in/itute ( ,/&>ds & ,te*nology1 ! ,dep>tm5t ( ,en]gy1 ! ,environm5tal ,protection ,ag5cy1 ! ,dep>tm5t ( ,agriculture1 ! ,dep>tm5t ( ,def5se1 ! ,national ,in/itutes ( ,heal?1 & any o!r ag5cy t ! ,presid5t may designate to ov]see ! plann+1 managem5t1 & coord9ation ( ! ,program4 7#b7 ,gov]nance ,! ,director ( ! ,national ,sci5ce ,f\ndation & ! ,assi/ant ,adm9i/rator = ,rese>* & ,developm5t ( ! ,environm5tal ,protection ,ag5cy1 or _! designees1 %all s]ve z co-*airs ( ! ,int]ag5cy ,work+ ,gr\p4 7#c7 ,responsibilities ,9 ov]see+ ! plann+1 managem5t1 & coord9ation ( ! ,program1 ! ,int]ag5cy ,work+ ,gr\p %all-- 7,a7 e/abli% goals & priorities = ! ,program1 9 consultation ) ! ,advisory ,c\ncil2 7,b7 provide = int]ag5cy coord9ation1 includ+ budget coord9ation1 ( activities "u ! ,program2 7,c7 meet n lat] ?an #ij days f its e/abli%m5t & p]iodically !reaft]2 & 7,d7 e/abli% & consult ) an ,advisory ,c\ncil on a regul> basis4 7#d7 ,memb]%ip ,! ,advisory ,c\ncil memb]s %all n be employees ( ! ,f$]al ,gov]nm5t & %all include a div]se repres5tation ( kn[l$geable individuals f ! private sector 7includ+ small- & m$ium-siz$ ent]prises f across ! value *a971 academia1 ,/ate & tribal gov]nm5ts1 & nongov]nm5tal organizations & o!rs :o are 9 a position to provide exp]tise4 7f7 ,ag5cy budget reque/s 7#a7 ,9 g5]al ,ea* ,f$]al ag5cy & dep>tm5t p>ticipat+ 9 ! ,program %all1 z "p ( its annual reque/ = appropriations to ! ,(fice ( ,managem5t & ,budget1 submit a report to ! ,(fice ( ,managem5t & ,budget t-- 7,a7 id5tifies ! activities ( ! ag5cy or dep>tm5t t contribute directly to ! ,program2 & 7,b7 /ates ! portion ( ! ag5cy or dep>tm5t's reque/ = appropriations t is allocat$ to ^? activities4 7#b7 ,annual budget reque/ to congress ,! ,presid5t %all include 9 ! annual budget reque/ to ,congress a /atem5t ( ! portion ( ! annual budget reque/ = ea* ag5cy or dep>tm5t t w be allocat$ to activities und]tak5 pursuant to ! ,program4 7g7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act1 ! ,int]ag5cy ,work+ ,gr\p %all submit a report to ! ,committee on ,sci5ce1 ,space1 & ,te*nology & ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,environm5t & ,public ,works & ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate t %all include-- 7,a7 a summ>y ( f$]ally fund$ su/a9able *emi/ry rese>*1 developm5t1 demon/ration1 te*nology transf]1 comm]cialization1 education1 & tra9+ activities2 7,b7 a summ>y ( ! f9ancial res\rces allocat$ to su/a9able *emi/ry initiatives2 7,c7 an analysis ( ! progress made t[>d a*iev+ ! goals & priorities ( ! program e/abli%$ pursuant to subsection 7c71 & recomm5dations = future program activities2 7,d7 an assessm5t ( ! b5efits ( exp&+ exi/+1 f$]ally-support$ regional innovation & manufactur+ hubs to include su/a9able *emi/ry & ! value ( direct+ ! creation ( #a or m d$icat$ su/a9able *emi/ry c5t]s ( excell5ce or hubs2 & 7,e7 an evaluation ( /eps tak5 & future /rategies to avoid duplication ( ef=ts1 /reaml9e int]ag5cy coord9ation1 facilitate in=mation %>+1 & spread be/ practices betwe5 p>ticipat+ ag5cies 9 ! ,program4 7#b7 ,submission to gao ,! ,int]ag5cy ,work+ ,gr\p %all also submit ! report describ$ 9 p>agraph 7#a7 to ! ,gov]nm5t ,acc\ntability ,(fice = consid]ation 9 future ,congressional inquiries4 4 #bd4 ,/ate programs ,section #bh ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbg7 is am5d$-- 7#a7 9 subsection 7b77#a7-- 7,a7 9 subp>agraphs 7,a7 ?r\gh 7,d71 by /rik+ ! comma at ! end ( ea* subp>agraph & ins]t+ a semicolon2 & 7,b7 9 subp>agraph 7,e71 by /rik+ 1 & & ins]t+ 2 &2 & 7#b7 by /rik+ subsections 7c7 & 7d74 #be4 ,au?orization ( appropriations ,section #bi ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbh7 is repeal$4 #bf4 ,annual report ,section #cj ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbi7 is am5d$ 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 #d2 4 #bg4 ,effective date ,section #ca ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja note2 ,public ,law #id-dfi7 is am5d$-- 7#a7 by /rik+ ,except z provid$ 9 section #d7;f71 ?is & ins]t+ ! foll[+3 7a7 ,9 g5]al ,?is 2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,retroactive applicability ,no?+ 9 ?is ,act %all be int]pret$ to apply retroactively to any ,/ate1 ,f$]al1 or m>itime legal action comm5c$ prior to ! effective date ( ! ,frank ,r4 ,laut5b]g ,*emical ,safety = ! #ba/ ,c5tury ,act4 4 ,june #ag1 #bjae,report$ ) an am5dm5t