,,ii #aad? ,,congress #a/ ,session ,s4 #gbe ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #ab1 #bjae,mrs4 ,box] 7= h]self1 ,mr4 ,m>key1 & ,mr4 ,s&]s7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,environm5t & ,public ,works ,a ,,bill ,to am5d ! ,toxic ,sub/ances ,control ,act1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,ref]5ces4 ,,title ,i--,am5dm5ts to ! ,toxic ,sub/ances ,control ,act ,sec4 #aja4 ,f9d+s1 policy1 & int5t4 ,sec4 #ajb4 ,def9itions4 ,sec4 #ajc4 ,policies1 proc$ures & guidance4 ,sec4 #ajd4 ,te/+ ( *emical sub/ances or mixtures4 ,sec4 #aje4 ,prioritization scre5+4 ,sec4 #ajf4 ,new *emicals & significant new uses4 ,sec4 #ajg4 ,safety assessm5ts & det]m9ations4 ,sec4 #ajh4 ,imm95t haz>ds4 ,sec4 #aji4 ,in=mation collection & report+4 ,sec4 #aaj4 ,relation%ip to o!r ,f$]al laws4 ,sec4 #aaa4 ,rese>*1 developm5t1 collection1 dissem9ation1 & utilization ( data4 ,sec4 #aab4 ,exports4 ,sec4 #aac4 ,imports4 ,sec4 #aad4 ,confid5tial in=mation4 ,sec4 #aae4 ,prohibit$ acts4 ,sec4 #aaf4 ,p5alties4 ,sec4 #aag4 ,preemption4 ,sec4 #aah4 ,judicial review4 ,sec4 #aai4 ,citiz5s' petitions4 ,sec4 #abj4 ,/udies4 ,sec4 #aba4 ,adm9i/ration4 ,sec4 #abb4 ,developm5t & evaluation ( te/ me?ods4 ,sec4 #abc4 ,/ate programs4 ,sec4 #abd4 ,au?orization ( appropriations4 ,sec4 #abe4 ,annual report4 ,,title ,,ii--,/r5g!n+ protections = *ildr5 & communities f disease clu/]s ,sec4 #bja4 ,purposes4 ,sec4 #bjb4 ,def9itions4 ,sec4 #bjc4 ,guidel9es = environm5tal inve/igations ( disease clu/]s4 ,sec4 #bjd4 ,enhanc$ support = environm5tal inve/igations ( disease clu/]s4 ,sec4 #bje4 ,f$]al reports to ,congress4 ,sec4 #bjf4 ,au?orization ( appropriations4 ,sec4 #bjg4 ,effect on o!r law4 ,,title ,,iii--,community disease clu/] te*nical assi/ance grants ,sec4 #cja4 ,community disease clu/] te*nical assi/ance grants4 ,sec4 #cjb4 ,au?orization ( appropriations4 #b4 ,ref]5ces ,except z o!rwise expressly provid$1 :]ev] 9 ?is ,act an am5dm5t or repeal is express$ 9 t]ms ( an am5dm5t to1 or repeal (1 a section or o!r provision1 ! ref]5ce %all be consid]$ to be made to a section or o!r provision ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq474 ,i ,am5dm5ts to ! ,toxic ,sub/ances ,control ,act #aja4 ,f9d+s1 policy1 & int5t ,section #b7;a7 7#ae ,u4,s4,c4 #bfja7;a77 is am5d$-- 7#a7 ,9 p>agraph 7#b7-- 7,a7 by /rik+ injury & ins]t+ h>m2 & 7,b7 by /rik+ & at ! end2 7#b7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#f72 & 7#c7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 re=m ( ?is ,act %all be adm9i/]$ to protect ! heal? ( *ildr51 pregnant wom51 ! eld]ly1 work]s1 consum]s1 ! g5]al public & ! environm5t f ! risks ( h>mful exposures to *emical sub/ances & mixtures2 7#d7 re=m ( ?is ,act %all n displace or supplant common law rights ( action or rem$ies = civil relief2 7#e7 re=m ( ?is ,act %all be adm9i/]$ to ensure t appropriate in=mation on *emical sub/ances & mixtures %\ld be available to public heal? (ficials & fir/ respond]s 9 ! ev5t ( an em]g5cy2 & 4 #ajb4 ,def9itions ,section #c 7#ae ,u4,s4,c4 #bfjb7 is am5d$-- 7#a7 by r$esignat+ p>agraphs 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 7#ac71 & 7#ad7 z p>agraphs 7#i71 7#aj71 7#aa71 7#ac71 7#ad71 7#ai71 7#bj71 & 7#ba71 respectively2 7#b7 by ins]t+ aft] p>agraph 7#f7 ! foll[+3 7#g7 ,in=mation ,except 9 section #ad1 ! t]m in=mation means any qualitative1 quantitative or descriptive facts1 data1 analysis or assessm5t relat$ to *emical haz>ds1 use1 or exposure 7includ+ ! nature & ext5t ( exposure to a *emical sub/ance71 includ+ f heal? & safety /udies4 7#h7 ,int5d$ or reasonably =eseeable conditions ( use ,! t]m int5d$ or reasonably =eseeable conditions ( use means ! circum/ances "u :i* a *emical sub/ance is int5d$1 reasonably kn[n1 or reasonably anticipat$ to be manufactur$1 process$1 di/ribut$ 9 comm]ce1 us$1 dispos$ (1 & releas$ into ! environm5t1 includ+ reasonably =eseeable b un9t5d$ exposure conditions f unplann$ releases into ! environm5t4 2 7#c7 by ins]t+ aft] p>agraph #aa 7z s r$esignat$7 ! foll[+3 7#ab7 ,pot5tially expos$ or susceptible population ,! t]m pot5tially expos$ or susceptible population means a gr\p or gr\ps ( individuals )9 ! g5]al population :o may be-- 7,a7 diff]5tially expos$ to *emical sub/ances "u ! int5d$ or reasonably =eseeable conditions ( use2 or 7,b7 m susceptible to adv]se heal? consequ5ces f *emical exposures ?an ! g5]al population1 :i* :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#ad7 7z s r$esignat$7 ! foll[+3 7#ae7 ,publicly available in=mation ,! t]m publicly available in=mation means in=mation t is g5]ally accessible & available to ! g5]al public or 9 ! public doma91 includ+ in=mation t has be5 publi%$ 9 p]iodicals1 books1 pr9t1 or electronic or o!r m$ia available = g5]al di/ribution to any memb] ( ! public4 7#af7 ,safety assessm5t ,! t]m safety assessm5t means an assessm5t ( ! risk pos$ by a *emical sub/ance "u ! int5d$ or reasonably =eseeable conditions ( use1 integrat+ haz>d1 use1 & exposure in=mation ab\t ! *emical sub/ance4 7#ag7 ,safety det]m9ation ,! t]m safety det]m9ation means a det]m9ation by ! ,adm9i/rator z to :e!r a *emical sub/ance meets ! safety /&>d "u ! int5d$ or reasonably =eseeable conditions ( use4 7#ah7 ,safety /&>d ,! t]m safety /&>d means a /&>d t ensures ) reasonable c]ta9ty1 )\t tak+ into consid]ation co/ or o!r non-risk factors1 t no h>m to human heal? or ! environm5t w result f exposure to a *emical sub/ance "u ! int5d$ or reasonably =eseeable conditions ( use1 includ+ no h>m to ! g5]al population or to any pot5tially expos$ or susceptible subpopulation t ! ,adm9i/rator has id5tifi$ z relevant to ! safety assessm5t & det]m9ation = a *emical sub/ance4 4 #ajc4 ,policies1 proc$ures & guidance ,! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq47 is am5d$ by add+ aft] section #c ! foll[+3 #c;,a4 ,policies1 proc$ures1 & guidance 7a7 ,deadl9e ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all1 aft] provid+ an opportunity = public notice & comm5t1 develop ! policies1 proc$ures & guidance requir$ by ?is section4 ,z us$ 9 ?is section1 ! t]m guidance includes any significant writt5 guidance ( g5]al applicability prep>$ by ! ,adm9i/rator4 7b7 ,use ( sci5ce ,9 e/abli%+ any policies1 proc$ures1 & guidance1 on ! use ( sci5ce 9 mak+ decisions "u ?is section & sections #d1 #d;,a1 #e1 & #f1 ! ,adm9i/rator %all h ! goal ( mak+ ! basis ( decisions cle> to ! public4 ,! policies1 proc$ures & any guidance issu$ "u ?is subsection %all describe h[ ! ,adm9i/rator w ensure t-- 7#a7 decisions by ! ,adm9i/rator-- 7,a7 are bas$ on ! be/ available sci5ce2 & 7,b7 take into acc\nt ! ext5t to :i*-- 7i7 assumptions & me?ods us$ to develop in=mation consid]$ by ! ,adm9i/rator are cle>ly & completely describ$ & docum5t$2 7ii7 v>iability & unc]ta9ty 9 su* in=mation are evaluat$ & *>act]iz$2 & 7iii7 ! in=mation has be5 subject to indep5d5t pe] review2 7#b7 to ! ext5t practicable & :]e appropriate1 ! use ( pe] review1 /&>diz$ te/ design & me?ods1 consi/5t data evaluation proc$ures1 & appropriate laboratory practices w be enc\rag$2 7#c7 ! names ( ! organizations or individuals fund+ ! g5]ation & assessm5t ( in=mation & ! degree ( control !y _h ov] ! g5]ation1 assessm5t1 & dissem9ation ( in=mation 7includ+ control ov] ! design ( ! "w & ! publication ( in=mation7 w be made cle>2 & 7#d7 decisions by ! ,adm9i/rator foll[ ! applicable recomm5dations 9 relevant ,national ,academy ( ,sci5ces reports1 includ+ ! reports titl$3 ,sci5ce & ,decisions3 ,advanc+ ,risk ,assessm5t1 ,ph?alates & ,cumulative ,risk ,assessm5t3 ,! ,task ,ahead1 ,review ( ,,epa's ,integrat$ ,risk ,in=mation ,sy/em 7,,iris7 ,process1 ,review ( ! ,=maldehyde ,assessm5t 9 ! ,national ,toxicology ,program #ab? ,report on ,c>c9og5s1 & ,review ( ! ,/yr5e ,assessm5t 9 ! ,national ,toxicology ,program #ab? ,report on ,c>c9og5s4 7c7 ,exi/+ ,,epa policies1 proc$ures & guidance ,! policies1 proc$ures1 & guidance describ$ 9 subsections 7a7 & 7b7 %all incorporate1 z appropriate1 exi/+ relevant haz>d1 exposure1 & risk assessm5t guidel9es & me?odologies1 data evaluation & quality crit]ia1 te/+ me?odologies & o!r relevant guidel9es & policies previ\sly issu$ by ! ,adm9i/rator4 7d7 ,review ,n less ?an #e ye>s aft] ! date ( enactm5t ( ?is ,act1 & n less frequ5tly ?an e #e ye>s !reaft]1 ! ,adm9i/rator %all-- 7#a7 review ! adequacy ( any policies1 proc$ures1 & guidance develop$ "u ?is section1 includ+ proc$ures = assess+ & det]m9+ risk "u ?is ,act2 & 7#b7 aft] provid+ an opportunity = public notice & comm5t1 revise ! policies1 proc$ures1 & guidance if necess>y to reflect new sci5tific developm5ts or und]/&+s4 7e7 ,s\rces ( in=mation ,9 mak+ any decision ) respect to a *emical sub/ance "u sections #d1 #d;,a1 #e1 & #f1 ! ,adm9i/rator %all consid] in=mation on ! haz>ds & exposures ( a *emical sub/ance "u ! int5d$ or reasonably =eseeable 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 basis 7includ+ pursuant to any reque/ made "u ?is ,act7 by-- 7,a7 manufactur]s & processors ( a sub/ance2 7,b7 ! public2 7,c7 o!r ,f$]al ag5cies & dep>tm5ts2 or 7,d7 a ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? or ! environm5t2 7#b7 submitt$ to a gov]nm5tal body 9 any jurisdiction "u a gov]nm5tal requirem5t relat+ to ! protection ( human heal? & ! 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 7f7 ,te/+ ( *emical sub/ances & mixtures 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% policies & proc$ures = ! te/+ ( *emical sub/ances or mixtures "u section #d4 ,a goal ( ! policies & proc$ures %all be to make ! basis ( decisions cle> to ! public4 7#b7 ,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 provid$ t ! ,adm9i/rator %all n int]pret ! lack ( exposure in=mation z a lack ( exposure or exposure pot5tial & t lack ( in=mation on exposure or exposure pot5tial %all n1 by itself1 be a reason n to require te/+2 7,b7 describe h[ ! ,adm9i/rator w det]m9e t additional te/+ is ne$$ to c>ry out ?is ,act1 includ+ te/+ relat$ to pot5tially expos$ or susceptible populations & te/+ relat$ to ! accumulation ( *emical sub/ances 9 ! human body2 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+ mammals1 require ! ,adm9i/rator to consid]1 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 models2 & 7iv7 sci5tifically reliable & relevant alt]natives to te/s on mammals t w\ld provide equival5t in=mation4 7#c7 ,ti]$ te/+ ,except z provid$ 9 subp>agraph 7,c71 ! ,adm9i/rator %all employ a ti]$ scre5+ & te/+ process1 9 :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,a7 ,scre5+ level ,! 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+ ( exposure1 z appropriate4 ,scre5+ level te/s %all be us$-- 7i7 to scre5 *emical sub/ances or mixtures = pot5tial adv]se effects2 & 7ii7 to in=m ! decision ( ! ,adm9i/rator :e!r additional te/+ is necess>y4 7,b7 ,additional te/+ ,if ! ,adm9i/rator det]m9es "u subp>agraph 7,a7 t additional te/+ is necess>y to provide m def9itive in=mation = prioritization or safety assessm5ts & safety det]m9ations1 ! ,adm9i/rator may require m advanc$ te/s = pot5tial human heal? or environm5tal effects or exposure4 7,c7 ,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 policies or proc$ures develop$ by ! ,adm9i/rator "u ?is subsection4 7g7 ,safety assessm5ts & safety det]m9ations 7#a7 ,s*$ule ,! ,adm9i/rator %all in=m ! public reg>d+ ! s*$ule = ! completion ( ea* safety assessm5t & safety det]m9ation z soon z possible aft] designation z a high priority sub/ance pursuant to section #d;,a4 ,! "t allott$ may be diff]5t = diff]5t *emicals1 provid$ t all s*$ules %all comply ) ! deadl9es e/abli%$ "u section #f4 7#b7 ,policies & proc$ures = safety assessm5ts & safety det]m9ations ,! ,adm9i/rator %all e/abli% policies & proc$ures on h[ ! ,adm9i/rator %all c>ry out section #f4 ,a goal ( ! policies & proc$ures %all be to make ! basis ( decisions cle> to ! public4 ,at a m9imum1 ! policies & proc$ures %all-- 7,a7 describe-- 7i7 h[ ! ,adm9i/rator w id5tify in=mational ne$s & seek su* in=mation f ! public2 7ii7 :at in=mation 7includ+ draft safety assessm5ts7 may be submitt$ by int]e/$ p]sons1 includ+ ,/ates2 & 7iii7 ! crit]ia by :i* t in=mation w be evaluat$2 7,b7 require ! ,adm9i/rator1 9 ea* safety assessm5t & safety det]m9ation1 to-- 7i7 id5tify ! sub/ance's int5d$ or reasonably =eseeable conditions ( use bas$ on in=mation provid$ by its manufactur]s & processors or o!rwise available to ! ,adm9i/rator2 7ii7 id5tify all pot5tially expos$ or susceptible populations t ! ,adm9i/rator det]m9es are p]t95t to ! sub/ance2 7iii7 id5tify ! haz>ds ( ! sub/ance & its metabolites & breakd[n products & any diff]5ces 9 ! magnitude or nature ( ^! haz>ds = pot5tially expos$ or susceptible populations1 includ+ ! pot5tial = *emical sub/ances to accumulate 9 ! human body2 7iv7 det]m9e ! nature & ext5t ( exposures to ! *emical sub/ance by ! g5]al population & ea* pot5tially expos$ or susceptible population1 includ+ aggregate exposures result+ f multiple pa?ways or r\tes ( exposure2 7v7 to ! ext5t practicable1 review & incorporate any available sci5tific in=mation on ! cumulative effects ( exposure to ! *emical sub/ance & o!r *emical sub/ances pos+ simil> haz>ds to human heal? & ! environm5t2 & 7vi7 *>act]ize ! nature & ext5t ( ! risk pres5t$ by ! *emical sub/ance1 tak+ into acc\nt aggregate exposures result+ f multiple pa?ways or r\tes ( exposure & ! cumulative effects ( exposure to ! *emical sub/ance & o!r *emicals pos+ simil> haz>ds2 & 7,c7 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 ( ! assessm5t or det]m9ation4 7h7 ,release ( safety assessm5ts ,subject to section #ad1 ! ,adm9i/rator %all-- 7#a7 make available to ! public a nonte*nical summ>y & ! f9al v]sion ( 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 ! li/ ( /udies consid]$ by ! ,adm9i/rator 9 c>ry+ out ! safety assessm5t & safety det]m9ation1 z well z ! li/ ( policies & proc$ures t 7 foll[$ 9 c>ry+ out ! safety assessm5t & safety det]m9ation4 7i7 ,consultation ) sci5ce advisory committee on *emicals 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all e/abli% a ,sci5ce ,advisory ,committee on ,*emicals 7ref]r$ to 9 ?is subsection z ! ,committee7 to provide indep5d5t advice & exp]t consultation1 ^u ! reque/ ( ! ,adm9i/rator1 ) respect to ! sci5tific & te*nical aspects ( issues relat+ to ! implem5tation ( ?is title4 7#b7 ,composition ( committee ,! ,committee %all be compos$ ( repres5tatives ( su* sci5ce1 gov]nm5t1 labor1 public heal?1 public int]e/1 indu/ry1 & o!r gr\ps z ! ,adm9i/rator deems 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#c7 ,meet+s ,! ,adm9i/rator %all conv5e ! ,committee on a s*$ule ! ,adm9i/rator det]m9es appropriate1 b n less frequ5tly ?an once e #b ye>s4 7#d7 ,f$]al ,advisory ,committee ,act ,all proce$+s & meet+s ( ! ,committee %all be subject to ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7#e7 ,conflict ( int]e/ policies ,! ,adm9i/rator %all e/abli% & make public conflict ( int]e/ policies t %all apply to ! ,committee memb]s1 :o %all be appo9t$ z ,special ,gov]nm5t ,employees4 7j7 ,national academy ( sci5ces reports ,n lat] ?an #abj days aft] ! issuance ( any report by ! ,national ,academy ( ,sci5ces conc]n+ haz>ds1 exposures1 or risks ( *emical sub/ances1 ! ,adm9i/rator %all issue a public response to ! pr9cipal recomm5dations ( ! report4 4 #ajd4 ,te/+ ( *emical sub/ances or mixtures 7a7 ,9 g5]al ,section #d 7#ae ,u4,s4,c4 #bfjc7 is am5d$-- 7#a7 by /rik+ subsection 7g7 & r$esignat+ subsections 7e7 & subsection 7f7 z subsections 7f7 & 7g71 respectively2 7#b7 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 by /rik+ rulemak+2 7#c7 9 subsection 7g7 7z s r$esignat$7-- 7,a7 by /rik+ f canc]1 g5e mutations1 or bir? defects2 7,b7 by /rik+ unreasonable ea* place x appe>s & ins]t+ significant2 & 7,c7 by /rik+ ! la/ s5t5ce2 & 7#d7 by /rik+ subsections 7a7 ?r\gh 7d7 & ins]t+ ! 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/ration det]m9es t ! in=mation is ne$$-- 7,a7 to p]=m a safety assessm5t or make a safety det]m9ation "u section #f2 7,b7 to implem5t a requirem5t impos$ 9 a cons5t agreem5t or ord] issu$ "u section #e7;c77#d72 7,c7 pursuant to section #ab7;a77#d72 or 7,d7 at ! reque/ ( ! implem5t+ au?ority "u any o!r ,f$]al law4 7#b7 ,te/+ = prioritization purposes ,! ,adm9i/rator may require ! developm5t ( new in=mation = ! purposes ( section #d;,a1 provid$ t any su* te/+ %all n be bas$ on a set ( uni=m m9imum in=mation requirem5ts = all or l>ge gr\ps ( *emical sub/ances4 ,use ( ?is au?ority %all be limit$ to cases :]e ! ,adm9i/rator det]m9es additional in=mation is ne$$ to e/abli% ! priority ( a *emical sub/ance4 7#c7 ,=m ,subject to section #c;,a7f71 ! ,adm9i/rator may require ! developm5t ( te/ data & in=mation describ$ 9 p>agraph 7#a7 or 7#b7 by-- 7,a7 promulgat+ a rule2 7,b7 ent]+ into a te/+ cons5t agreem5t2 or 7,c7 issu+ an ord]4 7#d7 ,cont5ts 7,a7 ,9 g5]al ,a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u ?is subsection %all include-- 7i7 id5tification ( ! *emical sub/ance or mixture = :i* te/+ is requir$2 7ii7 id5tification ( ! p]sons requir$ to conduct ! te/+2 7iii7 to ! ext5t practicable1 te/ protocols & me?odologies = ! developm5t ( in=mation = ! *emical sub/ance or mixture1 includ+ specific ref]5ce to reliable nonmammal te/ proc$ures2 & 7iv7 specification ( ! p]iod )9 :i* p]sons requir$ to conduct ! te/+ %all submit to ! ,adm9i/rator ! in=mation develop$ 9 accordance ) ! proc$ures describ$ 9 clause 7iii74 7,b7 ,duration ,! p]iod describ$ 9 subp>agraph 7,a77iv7 %all n be ( an unreasonable duration4 7,c7 ,consid]ations ,9 det]m9+ ! proc$ures & p]iod to be requir$ "u subp>agraph 7,a71 ! ,adm9i/rator %all consid]-- 7i7 ! relative co/s ( ! v>i\s te/ protocols & me?odologies t may be requir$2 & 7ii7 ! reasonably =eseeable availability ( facilities & p]sonnel ne$$ to p]=m ! te/+4 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 "u ?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 ( mammals4 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 = issuance ( an ord] in/ead ( promulgat+ a rule or ent]+ into a te/+ cons5t agreem5t4 7,b7 ,cont5ts ,! /atem5t describ$ 9 subp>agraph 7,a7 %all conta9 a discussion (-- 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$uction ( te/+ on mammals 7#a7 ,9 g5]al ,! ,adm9i/rator %all m9imize1 to ! ext5t practicable1 ! use ( mammals 9 te/+ ( *emical sub/ances or mixtures1 by-- 7,a7 enc\rag+ & facilitat+-- 7i7 ! use ( integrat$ & 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 ( mammals :ile provid+ in=mation ( high sci5tific quality2 7iv7 ! gr\p+ ( #b or m *emical sub/ances into sci5tifically appropriate categories 9 cases :]e te/+ ( a *emical sub/ance w\ld provide reliable & useful in=mation on o!rs 9 ! category2 7v7 ! =mation ( indu/ry consortia to jo9tly conduct te/+ to avoid unnecess>y duplication ( te/s2 & 7vi7 ! submission ( in=mation f animal-bas$ /udies & 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 mammals1 ! ,adm9i/rator %all-- 7,a7 aft] provid+ an opportunity = public comm5t1 develop a /rategic plan to promote ! developm5t & implem5tation ( alt]native te/ me?ods & te/+ /rategies to g5]ate in=mation us$ 9 safety assessm5ts & det]m9ations "u section #f t c r$uce1 ref9e1 or replace ! use ( mammals1 includ+ toxicity pa?way-bas$ risk assessm5t1 9 vitro /udies1 sy/ems biology1 computational toxicology1 bio9=matics1 & high-?r\ghput scre5+2 7,b7 beg9n+ on ! date t is #e ye>s aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,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,c7 to ! ext5t practicable1 fund & c>ry out rese>*1 developm5t1 p]=mance assessm5t1 & translational /udies to accel]ate ! developm5t ( te/ me?ods & te/+ /rategies t r$uce1 ref9e1 or replace ! use ( mammals 9 any safety assessm5t or det]m9ation made "u section #f4 7d7 ,te/+ requirem5ts 7#a7 ,9 g5]al ,! ,adm9i/rator may require ! foll[+ p]sons to develop in=mation3 7,a7 ,manufactur]s & processors ( ! *emical sub/ance or mixture4 7,b7 ,p]sons :o beg9 to manufacture or process su* *emical sub/ance or mixture-- 7i7 aft] ! effective date ( ! rule1 te/+ cons5t agreem5t1 or ord]2 b 7ii7 subject to p>agraph 7#c71 n lat] ?an #ahj days aft] ! completion ( ! p]iod = submitt+ in=mation specifi$ "u subsection 7a77#d77;,a77iv74 7#b7 ,designation ,! ,adm9i/rator may p]mit #b or m ( ! p]sons id5tifi$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 to designate a p]son 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 & ! p]son designat$4 7ii7 ,arbitration ,if ! applicant & a p]son designat$ "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 has compli$ ) ! rule1 te/+ cons5t agreem5t1 or ord]1 ! ,adm9i/rator %all-- 7i7 by ord] t]m9ate ! exemption2 & 7ii7 notify 9 writ+ ea* p]son :o receiv$ an exemption ( ! requirem5ts ) respect to :i* ! exemption 0 grant$4 7e7 ,transp>5cy ,subject to section #ad1 ! ,adm9i/rator %all make available to ! public all te/+ cons5t agreem5ts & ord]s "u ?is section4 4 7b7 ,con=m+ am5dm5ts ,section #ajd7;i77#e77;,a7 ( ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act ( #aihj 7#db ,u4,s4,c4 #ifjd7;i77#e77;,a77 is am5d$ by /rik+ section #d7;e7 & ins]t+ section #d7;f74 #aje4 ,prioritization scre5+ ,! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq47 is am5d$ by add+ aft] section #d ! foll[+3 #d;,a4 ,prioritization scre5+ 7a7 ,prioritization scre5+ 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all by rule e/abli% a scre5+ process & crit]ia = id5tify+ exi/+ *emical sub/ances t are-- 7,a7 a high priority = a safety assessm5t & safety det]m9ation "u section #f1 to be kn[n z high-priority sub/ances2 & 7,b7 a l[ priority = a safety assessm5t & safety det]m9ation1 to be kn[n z l[-priority sub/ances4 7#b7 ,initial li/ ( high priority sub/ances ,prior to promulgation ( ! rule e/abli%$ "u p>agraph 7#a7 & n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all consid] & publi% an initial li/ ( high priority sub/ances1 :i* %all conta9 n less ?an #ae *emical sub/ances1 & pursuant to sections #f7;a7 & #f7;b77#b71 initiate or cont9ue safety assessm5ts & safety det]m9ations = su* sub/ances4 7#c7 ,additions to priority li/ ,/>t+ #a ye> aft] publication ( ! initial priority li/ "u p>agraph 7#b7 & at #a ye> int]vals !reaft] = ! foll[+ #d ye>s1 ! ,adm9i/rator %all add at lea/ #ae high-priority sub/ances to ! li/ &1 pursuant to sections #f7;a7 & #f7;b77#b71 initiate or cont9ue safety assessm5ts & safety det]m9ations = ^? sub/ances4 7#d7 ,workplan & action plan *emicals ,! ,adm9i/ration may li/ z high-priority sub/ances "u p>agraphs 7#b7 & 7#c7 ^? *emical sub/ances or categories ( *emical sub/ances t are includ$ 9 ! ,adm9i/rator's ,m>* #bjab ,workplan 7z updat$ 9 ,octob] #bjad & by subsequ5t updates7 or are ! subject ( ,exi/+ ,*emical ,action ,plans publi%$ by ! ,adm9i/rator be=e ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act )\t provid+ fur!r ju/ification = li/+ or meet+ ! requirem5ts ( ?is section4 7#e7 ,implem5tation 7,a7 ,consid]ation ( active & inactive sub/ances 7i7 ,consid]ation ( active sub/ances ,9 implem5t+ ! process describ$ 9 p>agraph 7#a71 ! ,adm9i/rator %all consid] active sub/ances1 z det]m9$ "u section #h1 :i* may include sub/ances on ! int]im li/ ( active sub/ances e/abli%$ "u t section4 7ii7 ,consid]ation ( inactive sub/ances ,9 implem5t+ ! process describ$ 9 p>agraph 7#a71 ! ,adm9i/rator may consid] 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/ance2 & 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/ance2 & 7bb7 !re is ! pot5tial = residual high haz>ds or widespread exposures n o!rwise address$ by ! regulatory or o!r action4 7iii7 ,repopulation ,^u ! completion ( a safety det]m9ation "u section #f = a *emical sub/ance1 ! ,adm9i/rator %all remove ! sub/ance f ! li/ ( high-priority sub/ances4 ,! ,adm9i/rator %all add n less ?an #a *emical sub/ance to ! li/ ( high-priority sub/ances = ea* *emical sub/ance remov$ f ! li/1 until a safety assessm5t & safety det]m9ation is complet$ = all active sub/ances1 except t n less ?an #c *emical sub/ances %all be add$ = ea* *emical sub/ance remov$ f ! li/1 subject to section #ba1 :5 fees are 9 place4 7,b7 ,timely completion ( prioritization scre5+ process 7i7 ,9 g5]al ,9 addition to ! decisions requir$ by p>agraphs 7#a7 & 7#b71 n lat] ?an #f mon?s aft] ! effective date ( ! f9al rule "u p>agraph 7#a71 ! ,adm9i/rator %all beg9 ! prioritization scre5+ process4 7ii7 ,decisions on sub/ances subject to te/+ = prioritization purposes ,n lat] ?an #abj days aft] receipt ( ! in=mation comply+ ) a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u section #d7;a77#b71 ! ,adm9i/rator %all designate ! sub/ance z ei!r a high or l[ priority4 7iii7 ,consid]ation ,! ,adm9i/rator %all scre5 sub/ances1 tak+ into consid]ation ! requirem5t to meet ! deadl9es "u section #f ( ?is ,act4 7iv7 ,annual goal ,! ,adm9i/rator %all publi% an annual goal = ! numb] ( 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 safety assessm5ts & det]m9ations4 7,d7 ,publication ( li/ ( *emical sub/ances ,n less frequ5tly ?an annually1 ! ,adm9i/rator %all-- 7i7 publi% a li/ ( *emical sub/ances be+ consid]$ 9 ! prioritization scre5+ process & _! /atus 9 ! prioritization process1 includ+ ^? sub/ances = :i* a prioritization decision has be5 def]r$2 & 7ii7 publi% a li/ ( ^? sub/ances designat$ z high-priority & l[-priority sub/ances & ! basis = ! designations4 7#f7 ,crit]ia ,! crit]ia describ$ 9 p>agraph 7#a7 %all include-- 7,a7 ! recomm5dation ( a ,gov]nor ( a ,/ate or a ,/ate ag5cy ) responsibility = protect+ heal? or ! environm5t f *emical sub/ances appropriate = prioritization scre5+1 & ! recomm5dations ( ! public2 7,b7 ! haz>d ( ! *emical sub/ance 7or category ( sub/ances71 includ+ specific sci5tific classifications & designations by au?oritative gov]nm5tal entities2 7,c7 ! int5d$ or reasonably =eseeable conditions ( use ( a *emical sub/ance or significant *anges 9 ! int5d$ or reasonably =eseeable conditions ( use ( ! *emical sub/ance2 7,d7 evid5ce & indicators ( exposure & pot5tial exposure to humans or ! environm5t f ! *emical sub/ance includ+ pot5tially expos$ or susceptible populations2 7,e7 ! volume ( a *emical sub/ance manufactur$ or process$1 & pa/ & anticipat$ future *anges 9 volume2 7,f7 :e!r ! volume ( a *emical sub/ance z report$ "u a regulation issu$ "u section #h7;a7 has significantly increas$ or decreas$ s9ce a previ\s report or s9ce ! date on :i* a notice has be5 submitt$ "u section #e7;a7 = t *emical sub/ance2 7,g7 ! availability ( in=mation ab\t pot5tial haz>ds & exposures ne$$ = conduct+ a safety assessm5t or det]m9ation1 provid$ t limit$ availability ( relevant in=mation %all n be a suffici5t basis = fail+ to designate a sub/ance z a high priority2 7,h7 ! pot5tial ?reat ! *emical sub/ance poses to dr9k+ wat] supplies1 bas$ on haz>d1 exposure1 or exposure pot5tial 7includ+ :e!r ! *emical sub/ance is /or$ ne> s\rces ( dr9k+ wat]72 7,i7 ! ext5t to :i* a *emical sub/ance accumulates 9 ! human body2 & 7,j7 o!r relevant crit]ia id5tifi$ by ! ,adm9i/rator4 7b7 ,prioritization scre5+ process & decisions 7#a7 ,9 g5]al ,! prioritization scre5+ process develop$ "u subsection 7a7 %all include a requirem5t t ! ,adm9i/rator-- 7,a7 id5tify ! *emicals be+ consid]$ = prioritization2 7,b7 reque/ int]e/$ p]sons to supply in=mation on ! sub/ances be+ consid]$2 7,c7 apply ! crit]ia id5tifi$ 9 subsection 7a77#e72 & 7,d7 subject to p>agraph 7#d7 & 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 ,id5tification ( high-priority sub/ances ,! ,adm9i/rator-- 7,a7 %all id5tify z a high-priority sub/ance a *emical sub/ance t ! ,adm9i/rator det]m9es has1 or has ! pot5tial =1 significant haz>d & significant or sub/antial exposure2 7,b7 may id5tify z a high-priority sub/ance a *emical sub/ance t ! ,adm9i/rator det]m9es has1 or has ! pot5tial =1 significant haz>d or significant or sub/antial exposure2 7,c7 may id5tify z a high-priority sub/ance an inactive sub/ance1 z det]m9$ "u section #h7;b71 t ! ,adm9i/rator det]m9es w>rants a safety assessm5t & det]m9ation "u section #f2 & 7,d7 may id5tify z a high-priority sub/ance a *emical sub/ance t accumulates 9 ! body4 7#c7 ,id5tification ( l[-priority sub/ances ,! ,adm9i/rator %all id5tify z a l[-priority sub/ance a *emical sub/ance if ! ,adm9i/rator-- 7,a7 concludes t suffici5t haz>d & exposure in=mation is available = an in=m$ evaluation ( ! sub/ance's risks to human heal? & ! environm5t2 7,b7 det]m9es1 bas$ on a review ( ! in=mation available1 t ! sub/ance is likely to meet ! safety /&>d "u ! int5d$ or reasonably =eseeable conditions ( use2 & 7,c7 id5tifies ! in=mation on :i* ! det]m9ation is bas$ & describes ! ,adm9i/rator's analysis ( ?is in=mation4 7#d7 ,def]r+ a decision ,if ! ,adm9i/rator det]m9es t additional in=mation is ne$$ to e/abli% ! priority ( a *emical sub/ance1 ! ,adm9i/rator may def] ! prioritization scre5+ decision = a reasonable p]iod to-- 7,a7 all[ = ! submission & evaluation ( additional in=mation by an int]e/$ p]son2 or 7,b7 require ! developm5t ( in=mation pursuant to a rule1 te/+ cons5t agreem5t1 or ord] issu$ "u section #d7;a77#b74 7#e7 ,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 ( su* in=mation1 :i* deadl9e %all be ( reasonable duration4 7#f7 ,notice & comm5t ,except z provid$ 9 subsection 7a77#d71 ! ,adm9i/rator %all publi% ! propos$ decisions made "u p>agraphs 7#b71 7#c7 & 7#d7 & ! basis = ! decisions1 & provide an opportunity = public comm5t4 7#g7 ,revision bas$ on new in=mation ,! ,adm9i/rator may1 at any "t1 revise ! designation ( a *emical sub/ance z a high-priority or a l[-priority sub/ance bas$ on new in=mation made available to ! ,adm9i/rator aft] ! date ( ! det]m9ation "u p>agraph 7#b7 or 7#c71 foll[+ ! proc$ures 9 ?is section4 7#h7 ,review ,n less frequ5tly ?an once e #e ye>s aft] ! date on :i* ! process "u ?is subsection is e/abli%$1 ! ,adm9i/rator %all review ! process on ! basis ( exp]i5ce & consid] ! res\rces available to effici5tly & effectively scre5 & prioritize sub/ances1 & if necess>y modify ! prioritization scre5+ process 9 a mann] t complies ) ?is ,act4 7#i7 ,effect ,subject to section #ah1 a decision by ! ,adm9i/rator "u ?is subsection ) respect to a *emical sub/ance %all n be con/ru$ to affect ! manufacture1 process+1 di/ribution1 use1 or disposal ( ! *emical sub/ance1 or regulation ( ^? activities4 7c7 ,f9al ag5cy action ,except = ! designation ( a sub/ance z l[ priority "u subsection 7b77#c71 any action by ! ,adm9i/rator "u ?is section %all n be-- 7#a7 consid]$ to be a f9al ag5cy action2 or 7#b7 subject to judicial review4 4 #ajf4 ,new *emicals & significant new uses ,section #e 7#ae ,u4,s4,c4 #bfjd7 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & ins]t+ ! foll[+3 #e4 ,new *emicals & significant new uses 2 7#b7 9 subsection 7a77#a71 9 ! matt] foll[+ subp>agraph 7,b7-- 7,a7 by /rik+ subsection 7d7 & ins]t+ subsection 7b72 & 7,b7 by /rik+ & su* p]son complies ) any applicable requirem5t ( subsection 7b72 7#c7 by /rik+ subsection 7b72 7#d7 by r$esignat+ subsection 7d7 z subsection 7b7 & mov+ ! subsection s z to appe> aft] subsection 7a72 7#e7 9 subsection 7b7 7z s r$esignat$7-- 7,a7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,! notice requir$ "u subsection 7a7 %all include1 ) respect to a *emical sub/ance-- 7,a7 ! in=mation requir$ by sections #gbj4de & #gbj4ej ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations72 & 7,b7 in=mation reg>d+ int5d$ or reasonably =eseeable conditions ( use & reasonably =eseeable exposures4 2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ or ( data "u subsection 7b72 7ii7 9 subp>agraph 7,a71 by add+ & aft] ! semicolon at ! end2 7iii7 9 subp>agraph 7,b71 by /rik+ 2 & & ins]t+ a p]iod2 & 7iv7 by /rik+ subp>agraph 7,c72 & 7,c7 9 p>agraph 7#c71 by /rik+ 1 7b712 7#f7 by /rik+ subsection 7c7 & ins]t+ ! foll[+3 7c7 ,review ( notice 7#a7 ,initial review 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 n lat] ?an #ij days aft] ! date ( receipt ( a notice submitt$ "u subsection 7a71 ! ,adm9i/rator %all-- 7i7 conduct an initial review ( ! notice2 7ii7 z ne$$1 develop a pr(ile ( ! relevant *emical sub/ance & ! pot5tial = exposure to humans & ! environm5t2 & 7iii7 make any necess>y det]m9ation "u p>agraph 7#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 7b77#a72 & 7,b7 any o!r relevant in=mation available to1 or submitt$ to1 ! ,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 ! ,adm9i/rator %all det]m9e t-- 7,a7 ! relevant *emical sub/ance or a significant new use is n likely to meet ! safety /&>d1 9 :i* case ! ,adm9i/rator %all take appropriate action "u p>agraph 7#e72 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 ,9 g5]al ,if ! ,adm9i/rator makes a det]m9ation "u p>agraph 7#c77;,a7 or 7,c7 ) respect to a notice submitt$ "u subsection 7a71 ! ,adm9i/rator %all be=e ! end ( ! applicable p]iod = review "u p>agraph 7#a7 & by cons5t agreem5t or ord]1 z appropriate1 prohibit or re/rict ! manufacture1 process+1 use1 di/ribution 9 comm]ce1 or disposal 7z applicable7 ( ! *emical sub/ance1 or ( ! sub/ance = a significant new use )\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 /&>d4 7,b7 ,rulemak+ ,n lat] ?an #ij days aft] issu+ a cons5t agreem5t or ord] "u subp>agraph 7,a71 ! ,adm9i/rator %all-- 7i7 consid] :e!r to promulgate a rule "u subsection 7a77#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 use t is n 9 compliance ) ! re/rictions impos$ by ! cons5t agreem5t or ord]2 & 7ii7 7,i7 initiate su* rulemak+2 or 7,,ii7 publi% a /atem5t ( ! ,adm9i/rator's reasons = n initiat+ su* action4 7,c7 ,inclusions ,a prohibition1 re/riction1 or requirem5t "u subp>agraph 7,a7 %all include1 z appropriate1 #a or m ( ! foll[+ requirem5ts3 7i7 ,a requirem5t t a *emical sub/ance or mixture or article conta9+ ! sub/ance be m>k$ )1 or accompani$ by1 cle> & adequate w>n+s & in/ructions ) respect to use1 di/ribution 9 comm]ce1 or disposal1 or any comb9ation ( ^? activities1 ) ! =m & cont5t ( ! w>n+s & in/ructions to be prescrib$ by ! ,adm9i/rator4 7ii7 ,a requirem5t t manufactur]s or processors1 z applicable1 ( ! *emical sub/ance or mixture make & reta9 records ( ! processes us$ to manufacture or process ! *emical sub/ance4 7iii7 ,a requirem5t t manufactur]s or processors1 z applicable1 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 disposal ( ! *emical sub/ance1 subject to section #d4 7iv7 ,a re/riction on ! quantity ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce4 7v7 ,a re/riction on ! quantity ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce-- 7,i7 = a p>ticul> use2 or 7,,ii7 = a p>ticul> use 9 a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator 9 ! cons5t agreem5t or ord] impos+ ! requirem5t4 7vi7 ,a prohibition or o!r regulation ( ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance = a significant new use4 7vii7 ,a prohibition or o!r regulation ( any mann] or me?od ( comm]cial use ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance4 7viii7 ,a prohibition or o!r regulation ( any mann] or me?od ( disposal ( or environm5tal release ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance1 by its manufactur] or processor or by any o!r p]son :o uses1 or disposes ( x1 = comm]cial purposes4 7ix7 ,a prohibition or o!r appropriate re/riction or requirem5t on ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance4 7x7 ,a prohibition or o!r appropriate re/riction or requirem5t on ! manufacture1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance = a p>ticul> use4 7,d7 ,rule ( con/ruction ,! requirem5t1 w>n+1 or in/ruction requir$ "u subp>agraph 7,c7 does n e/abli% a uni=m national /&>d = ! purpose ( supplant+1 displac+1 or preempt+ ,/ate law4 7,e7 ,workplace exposures ,! ,adm9i/rator %all consult ) ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal? prior to adopt+ any prohibition or re/riction adopt$ "u ?is subsection to address workplace exposures4 7#e7 ,additional in=mation ,if ! ,adm9i/rator det]m9es "u p>agraph 7#c77;,c7 t additional in=mation is ne$$ 9 ord] to conduct a review "u ?is subsection1 ! ,adm9i/rator-- 7,a7 %all provide an opportunity = ! submitt] ( ! notice to submit su* additional in=mation2 7,b7 may1 by agreem5t ) ! submitt]1 ext5d ! review p]iod = a reasonable "t to all[ ! developm5t & submission ( ! additional in=mation2 7,c7 may promulgate a rule1 ent] into a te/+ cons5t agreem5t1 or issue an ord] "u section #d to require ! developm5t ( ! in=mation2 & 7,d7 %all1 aft] receiv+ in=mation ! ,adm9i/rator f9ds supports ! det]m9ation "u p>agraph 7#c71 promptly make ! det]m9ation4 7#f7 ,regulation p5d+ developm5t ( in=mation ,subject to p>agraph 7#d77;,b71 ! ,adm9i/rator may p]mit manufacture = comm]cial purposes to comm5ce p5d+ receipt ( ! additional in=mation1 subject to compliance ) any re/rictions "u p>agraph 7#d7 det]m9$ by ! ,adm9i/rator to be suffici5t to ensure t ! *emical sub/ance is likely to meet ! safety /&>d4 7#g7 ,comm5cem5t ( manufacture ,subject to p>agraphs 7#d71 7#e71 & 7#f71 at ! end ( ! applicable p]iod = review "u p>agraph 7#a77;,a7 ! submitt] ( a notice "u subsection 7a7 may comm5ce manufacture = comm]cial purposes a *emical sub/ance1 or a *emical sub/ance = a significant new use4 2 7#g7 by /rik+ subsections 7e7 ?r\gh 7g7 & ins]t+ ! foll[+3 7d7 ,notice ( comm5cem5t 7#a7 ,9 g5]al ,n lat] ?an #cj days aft] ! date on :i* a manufactur] or processor t has submitt$ a notice "u subsection 7a7 comm5ces nonexempt comm]cial manufacture ( a *emical sub/ance1 ! manufactur] or processor %all submit to ! ,adm9i/rator a notice ( comm5cem5t t id5tifies-- 7,a7 ! "n ( ! manufactur] or processor2 7,b7 ! initial date ( nonexempt comm]cial manufacture2 & 7,c7 additional in=mation specifi$ 9 section #gbj4ajb7;c77#a7 ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,)drawal ,a manufactur] or processor t has submitt$ a notice "u subsection 7a71 b t has n comm5c$ nonexempt comm]cial manufacture or process+ ( ! *emical sub/ance1 may )draw ! notice4 7e7 ,fur!r evaluation ,! ,adm9i/rator may scre5 a *emical sub/ance "u section #d;,a or require te/+ "u section #d at any "t aft] ! ,adm9i/rator receives-- 7#a7 a notice ( comm5cem5t = a *emical sub/ance "u subsection 7d72 or 7#b7 new in=mation reg>d+ ! *emical sub/ance4 7f7 ,transp>5cy ,subject to section #ad1 ! ,adm9i/rator %all make available to ! public all notices1 det]m9ations1 cons5t agreem5ts1 rules & ord]s ( ! ,adm9i/rator issu$ "u ?is section4 2 7#h7 by r$esignat+ subsections 7h7 & 7i7 z subsections 7g7 & 7h71 respectively2 7#i7 9 subsection 7g7 7z s r$esignat$7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ or 7b72 7,b7 by /rik+ p>agraph 7#b72 7,c7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#f7 z p>agraphs 7#b7 ?r\gh 7#e71 respectively2 7,d7 9 p>agraph 7#b7 7z s r$esignat$71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7a72 7,e7 9 p>agraph 7#c7 7z s r$esignat$71 9 ! fir/ s5t5ce1 by /rik+ w n pres5t an unreasonable risk ( injury to heal? or ! environm5t & ins]t+ w meet ! safety /&>d2 7,f7 9 p>agraph 7#d7 7z s r$esignat$71 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7a72 & 7,g7 9 p>agraph 7#e7 7z s r$esignat$71 9 ! fir/ s5t5ce1 by /rik+ p>agraph 7#a7 or 7#e7 & ins]t+ p>agraph 7#a7 or 7#d712 & 7#aj7 by ins]t+ aft] subsection 7h7 7z s r$esignat$7 ! foll[+3 7i7 ,prior actions ,no?+ 9 ?is section requires ! ,adm9i/rator to modify or )draw any rule or ord] promulgat$ "u section #e ( ?is title prior to ! enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 4 #ajg4 ,safety assessm5ts & det]m9ations ,section #f 7#ae ,u4,s4,c4 #bfje7 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & ins]t+ ! foll[+3 #f4 ,safety assessm5ts & det]m9ations 2 7#b7 by r$esignat+ subsection 7b7 z subsection 7m7 & mov+ ! subsection s z to appe> aft] subsection 7l7 7z add$ by p>agraph 7#f772 7#c7 9 subsection 7m7 7z s r$esignat$71 by /rik+ unreasonable ea* place x appe>s & ins]t+ significant2 7#d7 by /rik+ subsections 7a71 7c7 & 7d7 & ins]t+ 9 lieu !re( ! foll[+1 & by r$esignat+ subsection 7b7 z subsection 7i73 7a7 ,9 g5]al ,! ,adm9i/rator-- 7#a7 %all conduct a safety assessm5t & make a safety det]m9ation ( ea* high-priority sub/ance designat$ "u section #d;,a 9 accordance ) subsections 7b7 & 7c72 7#b7 %all1 :5 a safety det]m9ation concludes t a sub/ance does n meet ! safety /&>d1 e/abli% re/rictions pursuant to subsection 7d72 7#c7 %all complete a safety assessm5t & safety det]m9ation n lat] ?an #b ye>s aft] ! date on :i* a sub/ance is designat$ z a high priority2 7#d7 %all promulgate a f9al rule pursuant to subsection 7d7 n lat] ?an #b ye>s aft] ! date on :i* ! safety det]m9ation is complet$2 & 7#e7 may ext5d any deadl9e "u ?is subsection = a reasonable p]iod ( "t aft] an adequate public ju/ification1 subject to ! condition t ! aggregate l5g? ( all ext5sions ( deadl9es "u p>agraphs 7#c7 & 7#d7 ( ?is subsection & any def]rals "u subsection 7c77#b7 does n exce$ #b ye>s4 7b7 ,safety assessm5ts & det]m9ations 7#a7 ,9 g5]al ,! ,adm9i/rator %all conduct a risk-bas$ safety assessm5t & make a risk-bas$ safety det]m9ation ( ea* high-priority sub/ance4 7#b7 ,already initiat$ assessm5ts 7,a7 ,9 g5]al ,no?+ 9 ?is ,act prev5ts ! ,adm9i/rator f initiat+ safety assessm5ts & safety det]m9ations ( *emical sub/ances1 or f cont9u+ or complet+ safety assessm5ts & safety det]m9ations initiat$ prior to ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 prior to ! date on :i* ! policies & proc$ures ! ,adm9i/rator is direct$ to e/abli% "u section #c;,a & #d;,a are effective4 7,b7 ,integration ,z policies & proc$ures "u section #c;,a & #d;,a are e/abli%$1 ! ,adm9i/rator %all integrate !m into ongo+ assessm5ts & det]m9ations to ! maximum ext5t practicable4 7#c7 ,actions complet$ 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 m]ely because su* action 0 complet$ prior to ! completion ( a policy or proc$ure e/abli%$ "u section #c;,a or #d;,a1 & ! validity ( su* assessm5t1 det]m9ation1 or rule %all n be det]m9$ bas$ on ! cont5t ( su* policy or proc$ure4 7c7 ,safety det]m9ations 7#a7 ,9 g5]al ,bas$ on a review ( ! in=mation be=e ! ,adm9i/rator1 includ+ draft safety assessm5ts1 if any1 submitt$ by int]e/$ p]sons1 ! ,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 %all by rule "u subsection 7d7 impose re/rictions necess>y to assure t ! sub/ance meets ! safety /&>d "u ! int5d$ or reasonably =eseeable conditions ( use1 or1 :]e ! safety /&>d _c be met ) ! application ( re/rictions1 to ban or phase out ! sub/ance1 z appropriate2 or 7,c7 additional in=mation is necess>y 9 ord] to make a safety 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 ne$$ 9 ord] to c>ry out a safety assessm5t & 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 t complies ) ! deadl9es 9 subsection 7a71 a safety assessm5t & det]m9ation until aft] receipt ( ! in=mation2 & 7,d7 9 compliance ) ! deadl9es 9 subsection 7a71 %all1 ^u receipt ( in=mation ! ,adm9i/rator f9ds supports ! assessm5t & det]m9ation1 make a det]m9ation "u p>agraph 7#a74 7#c7 ,deadl9e = submission ( in=mation ,:5 reque/+ ! developm5t or submission ( in=mation "u ?is section ! ,adm9i/rator %all e/abli% a deadl9e = ! submission ( su* in=mation1 :i* deadl9e %all be ( reasonable duration & %all comply ) ! deadl9es "u subsection 7a74 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 ,a rule promulgat$ "u ?is subsection-- 7,a7 may-- 7i7 apply to a mixture or article conta9+ ! *emical sub/ance1 z appropriate2 & 7ii7 exempt a replacem5t "p manufactur$ prior to ! applicable compliance deadl9e2 & 7,b7 %all include dates by :i* compliance is m&atory1 :i* %all be z soon z feasible & may v>y = diff]5t affect$ p]sons1 z ! ,adm9i/rator det]m9es to be appropriate1 b :i* %all be no lat] ?an #b ye>s aft] ! date on :i* ! rule is promulgat$4 7#c7 ,workplace exposures ,! ,adm9i/rator %all consult ) ! ,assi/ant ,secret>y ( ,labor = ,occupational ,safety & ,heal? prior to adopt+ any prohibition or re/riction adopt$ "u ?is subsection to address workplace exposures4 7#d7 ,re/rictions ,a re/riction "u p>agraph 7#a7 %all include1 z appropriate1 #a or m ( ! foll[+ requirem5ts3 7,a7 ,a requirem5t t a *emical sub/ance or a mixture or article conta9+ ! sub/ance be m>k$ )1 or accompani$ by1 cle> & adequate w>n+s & in/ructions ) respect to use1 di/ribution 9 comm]ce1 or disposal1 or any comb9ation ( ^? activities1 ) ! =m & cont5t ( ! w>n+s & in/ructions to be prescrib$ by ! ,adm9i/rator4 7,b7 ,a requirem5t t manufactur]s & processors ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance-- 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 & 7iii7 monitor or conduct te/s :i* are reasonably necess>y to assure compliance ) ! requirem5ts ( any rule "u ?is subsection4 7,c7 ,a re/riction on ! quantity ( ! *emical sub/ance or a mixture or article conta9+ ! sub/ance t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce4 7,d7 ,a requirem5t to ban or phase out or o!r regulation on ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( ! *emical sub/ance or a mixture or article conta9+ ! 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 uses4 7,e7 ,a re/riction on ! quantity ( ! *emical sub/ance or mixture or article conta9+ ! 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/rator4 7,f7 ,a requirem5t to re/rict1 ban1 or phase out or o!r regulation ( any mann] or me?od ( comm]cial use or environm5tal release ( ! *emical sub/ance or mixture or article conta9+ ! sub/ance4 7,g7 ,a requirem5t to re/rict1 ban1 or phase out or o!r regulation ( any mann] or me?od ( disposal ( ! *emical sub/ance or any mixture or article conta9+ ! *emical sub/ance1 by its manufactur] or processor or by any p]son :o uses1 or disposes ( x1 = comm]cial purposes1 provid$ t su* a requirem5t may n require any p]son to take any action t w\ld be 9 violation ( any law or requirem5t (1 or 9 effect =1 a ,/ate or political subdivision1 & t su* a requirem5t %all require ea* p]son subject to ! requirem5t to notify ea* ,/ate & political subdivision 9 :i* a requir$ disposal may occur ( su* disposal4 7,h7 ,a requirem5t direct+ manufactur]s or processors ( ! *emical sub/ance or mixture or article conta9+ ! sub/ance to give notice ( significant risks ( h>m 7)\t tak+ into consid]ation co/ or o!r non-risk factors7 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/ance or mixture1 & to give public notice ( su* significant risks ( h>m4 7#e7 ,rule ( con/ruction ,! requirem5t1 w>n+1 or in/ruction1 "u p>agraph 7#d7 does n e/abli% a uni=m national /&>d = ! purpose ( supplant+1 displac+1 or preempt+ ,/ate law4 7#f7 ,analysis = rulemak+ 7,a7 ,9 g5]al ,:]e ! ,adm9i/rator det]m9es t a rule "u p>agraph 7#a7 is likely to h an annual effect on ! economy ( m ?an #ajj1jjj1jjj1 !n :5 decid+ :i* re/rictions to impose "u p>agraph 7#c7 z "p ( develop+ a rule "u p>agraph 7#a7 to ensure t a *emical sub/ance meets ! safety /&>d1 ! ,adm9i/rator %all consid]1 to ! ext5t practicable bas$ on reasonably available in=mation1 ! quantifiable & non-quantifiable co/s & b5efits ( ! propos$ regulatory action & ( ! prim>y alt]native regulatory action or actions t ! ,adm9i/rator det]m9es w ensure t ! sub/ance meets ! safety /&>d4 ,z "p ( ! analysis1 ! ,adm9i/rator %all review su* te*nically & economically feasible alt]native or alt]natives to ! *emical sub/ance t ! ,adm9i/rator det]m9es are relevant to ! rulemak+4 7,b7 ,public disclosure ( analysis ,:5 propos+ a rule "u p>agraph 7#a71 ! ,adm9i/rator %all make publicly available any analysis conduct$ "u subp>agraph 7,a74 7,c7 ,consid]ation ( analysis ,:5 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#g7 ,exemptions 7,a7 ,9 g5]al ,! ,adm9i/rator1 z "p ( a rulemak+ "u ?is subsection-- 7i7 may exempt a use ( a *emical sub/ance f any re/riction 9 a rule promulgat$ "u p>agraph 7#a7 if ! ,adm9i/rator det]m9es1 bas$ on reasonably available in=mation1 t ! rule _c be compli$ ) )\t-- 7,i7 h>m+ national security2 7,,ii7 caus+ significant disruption 9 ! national economy due to ! lack ( availability ( a *emical sub/ance = ! exempt$ use2 or 7,,iii7 int]f]+ ) a critical or ess5tial use = :i* no te*nically & economically feasible saf] alt]native is available1 consid]+ haz>d & exposure2 & 7ii7 may exempt a p>ticul> use ( a *emical sub/ance f a re/riction 9 a rule issu$ "u p>agraph 7#a7 if available in=mation demon/rates t ! risks to heal? or ! environm5t f cont9u$ use ( ! sub/ance are sub/antially l[] ?an ! risks to heal? or ! environm5t ( replac+ t use ( ! sub/ance ) reasonably available alt]natives4 7,b7 ,exemption analysis ,:5 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$ = su* exemption4 7,c7 ,consid]ation ( analysis ,:5 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 0 tak5 into acc\nt4 7,d7 ,conditions ,z "p ( a rule issu$ "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 human heal? & ! environm5t :ile a*iev+ ! purposes ( ! exemption4 7,e7 ,duration 7i7 ,9 g5]al ,! ,adm9i/rator %all1 z "p ( a rule "u p>agraph 7#a7 t conta9s an exemption "u ?is p>agraph1 set a "t limit on any exemption n to exce$ #e ye>s4 7ii7 ,ext5sion ,! ,adm9i/rator may1 by rule1 ext5d1 modify1 or elim9ate ! exemption :5 ! ,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]ation = ext5sion ,! ,adm9i/rator %all issue exemptions & e/abli% "t p]iods "u ?is subp>agraph by consid]+ factors det]m9$ by ! ,adm9i/rator z relevant to ! goals ( fo/]+ innovation & ! developm5t ( alt]natives t meet ! safety /&>d4 7iv7 ,exception = rule requir+ ban or phase out ,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 ( ?is section to be effective ^u publication ( ! propos$ rule 9 ! ,f$]al ,regi/] & until ! effective date ( a f9al action tak5 respect+ su* rule 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 su* propos$ rule or any comb9ation ( su* activities is likely to result 9 a significant risk ( s]i\s or widespread injury 7)\t tak+ into consid]ation co/ or o!r non-risk factors7 to heal? or ! environm5t be=e su* effective date2 & 7,b7 mak+ ! propos$ rule 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 9 an action "u section #g ( ?is title grant$ relief ) respect to ! risk associat$ ) ! sub/ance or mixture4 7f7 ,exp$it$ action on ,p,b,ts 7#a7 ,li/ ( ,p,b,ts ,9 addition to c>ry+ out section #d;,a1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all publi% a li/ ( *emical sub/ances t ! ,adm9i/rator det]m9es are p]si/5t1 bio-accumulative1 & toxic & h ! pot5tial = high or widespread exposure 7ref]r$ to 9 ?is subsection z ,p,b,ts74 7#b7 ,use & exposure assessm5t 7,a7 ,9 g5]al ,n lat] ?an #fj days aft] publi%+ ! ,,pbt li/ requir$ "u p>agraph 7#a71 ! ,adm9i/rator %all require by ord] ! submission by manufactur]s or processors ( *emical sub/ances includ$ 9 ! li/ ( any additional in=mation ! ,adm9i/rator det]m9es to be necess>y to conduct an exp$it$ assessm5t ( ! int5d$1 kn[n1 or reasonably =eseeable uses (1 & exposures to1 su* *emical sub/ances4 7,b7 ,publication ,n lat] ?an #a ye> aft] receiv+ ! in=mation :i* manufactur]s & processors are requir$ to submit "u subp>agraph 7,a71 ! ,adm9i/rator %all complete & publi% an id5tification & assessm5t ( ! int5d$ or reasonably =eseeable conditions ( use (1 & exposures to1 sub/ances on ! ,,pbt li/4 7#c7 ,exposure r$uction 7,a7 ,rule ,z soon z practicable1 b n lat] ?an #b ye>s aft] ! date on :i* ! ,adm9i/rator completes ! use & exposure assessm5t requir$ "u p>agraph 7#b71 ! ,adm9i/rator %all impose1 by rule1 re/rictions t ! ,adm9i/rator det]m9es to be necess>y to a*ieve ! maximum practicable r$uction 9 human or environm5tal exposure to *emical sub/ances includ$ 9 ! ,,pbt li/4 7,b7 ,cont5ts ( rules ,a rule promulgat$ "u subp>agraph 7,a7 may include any ( ! re/rictions on manufactur+1 process+1 use1 di/ribution 9 comm]ce1 & disposal describ$ 9 subsection 7d77#d7 :i* ! ,adm9i/rator det]m9es are necess>y to a*ieve maximum practicable r$uction 9 exposure to ! li/$ ,,pbt sub/ance4 7,c7 ,effective date ,a rule promulgat$ "u subp>agraph 7,a7 %all include an effective date 9 accordance ) subsection 7d77#b77;,b7 & may be made effective ^u publication ( a propos$ rule 9 accordance ) subsection 7f74 7#d7 ,exemptions 7,a7 ,scope & basis ,a rule impos+ a re/riction on a li/$ ,,pbt sub/ance 9 accordance ) subp>agraph 7#c7 may exempt a use ( ! sub/ance f su* re/riction ^u a %[+ satisfactory to ! ,adm9i/rator t ! use meets ! exemption crit]ia 9 subsection 7d77#g74 7,b7 ,conditions ,! ,adm9i/rator %all include conditions 9 any exemption e/abli%$ "u ?is p>agraph1 includ+ reasonable recordkeep+1 monitor+1 & report+ requirem5ts1 to ! ext5t necess>y to protect heal? or ! environm5t :ile a*iev+ ! purposes ( ! exemption4 7,c7 ,duration ,an exemption e/abli%$ "u ?is p>agraph %all be 9 effect = a p]iod det]m9$ by ! ,adm9i/rator b n to exce$ #e ye>s &1 aft] public notice & an opportunity = comm5t1 may be r5ew$ by ! ,adm9i/rator = #a or m p]iods n exce$+ a total ( #e ye>s by ord] foll[+ submission ( an application ju/ify+ ! cont9u+ ne$ = ! exemption & conta9+ su* in=mation z ! ,adm9i/rator may require4 7g7 ,report on public build+s ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all submit to ,congress a report on h[ data on exposure 9 public build+s w be ga!r$ to c>ry out subsection 7f7 & on :at te/+ is necess>y to protect ! public f exposures to *emical sub/ances id5tifi$ "u subsection 7f7 9 public build+s4 7h7 ,f9al ag5cy action ,"u ?is section-- 7#a7 a safety det]m9ation1 toge!r ) ! associat$ safety assessm5t1 = a sub/ance t ! ,adm9i/rator det]m9es "u subsection 7c7 meets ! safety /&>d1 %all be consid]$ to be a f9al ag5cy action on ! date ( ! f9al safety det]m9ation2 & 7#b7 a f9al rule promulgat$ "u subsection 7d71 toge!r ) ! associat$ safety assessm5t & safety det]m9ation t a sub/ance does n meet ! safety /&>d1 %all be consid]$ to be f9al ag5cy action on ! date ( promulgation ( ! f9al rule4 2 7#e7 by r$esignat+ subsections 7e7 & 7f7 z subsections 7i7 & 7j71 respectively2 & 7#f7 9 subsection 7i7 7z s r$esignat$7-- 7,a7 by /rik+ p>agraph 7#d72 & 7,b7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#d72 & 7#g7 by ins]t+ aft] subsection 7j7 7z s r$esignat$7 ! foll[+3 7k7 ,prior actions ,no?+ 9 ?is section %all be con/ru$ z requir+ ! ,adm9i/rator to modify or )draw any rule or ord] promulgat$ "u section #f ( ?is title promulgat$ prior to ! enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 4 7l7 ,asbe/os 7#a7 ,li/+ ,! ,adm9i/rator %all include all =ms ( asbe/os z #a high-priority *emical sub/ance "u section #d;,a7a77#b7 9 accordance ) section #d;,a7a77#d74 7#b7 ,s*$ule ,not)/&+ p>agraphs 7#c71 7#d7 & 7#e7 ( subsection 7a71 ! ,adm9i/rator %all-- 7,a7 complete a safety assessm5t & safety det]m9ation ( all =ms ( asbe/os n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act2 & 7,b7 promulgate a f9al rule n lat] ?an #c ye>s aft] ! date ( enactm5t ( t ,act4 4 #ajh4 ,imm95t haz>ds ,section #g 7#ae ,u4,s4,c4 #bfjf7 is am5d$-- 7#a7 by /rik+ subsection 7a7 & ins]t+ ! foll[+3 7a7 ,civil actions 7#a7 ,9 g5]al ,! ,adm9i/rator may comm5ce a civil action 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates =-- 7,a7 seizure ( an imm95tly haz>d\s *emical sub/ance or mixture or any article conta9+ ! sub/ance or mixture2 7,b7 relief 7z au?oriz$ by subsection 7b77 aga9/ any p]son :o manufactures1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( an imm95tly haz>d\s *emical sub/ance or mixture or any article conta9+ ! sub/ance or mixture2 or 7,c7 bo? seizure describ$ 9 subp>agraph 7,a7 & relief describ$ 9 subp>agraph 7,b74 7#b7 ,rule1 ord]1 or o!r proce$+ ,a civil action may be comm5c$ "u ?is subsection not)/&+-- 7,a7 ! exi/5ce (-- 7i7 a decision by ! ,adm9i/rator "u section #d1 #e7;c77#f71 #f7;c77#b7 or #f7;h72 or 7ii7 a rule1 te/+ cons5t agreem5t1 or ord] "u section #d7;d71 #e7;c77#d71 #f7;d71 or title ,,iv2 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 #aji4 ,in=mation collection & report+ ,section #h 7#ae ,u4,s4,c4 #bfjg7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#d7 ,regulations 7,a7 ,deadl9e 7i7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all promulgate rules requir+ ! ma9t5ance ( records & ! report+ ( in=mation kn[n by1 or reasonably asc]ta9able by1 ! p]son mak+ ! report1 includ+ rules requir+ processors to report in=mation1 s t ! ,adm9i/rator has ! in=mation necess>y to c>ry out sections #d & #f4 7ii7 ,prior regulations ,9 c>ry+ out ?is subp>agraph1 ! ,adm9i/rator may modify1 z appropriate1 ! regulations promulgat$ prior to ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 7,b7 ,cont5ts ,! rules promulgat$ "u subp>agraph 7,a7-- 7i7 may impose diff]5t report+ & record ret5tion 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$2 & 7iii7 %all require report+ ( in=mation or ma9t5ance ( records :]e ! ,adm9i/rator det]m9es ! submission ( reports w\ld assi/ 9 ! effective implem5tation ( ?is ,act4 7,c7 ,adm9i/ration ,9 implem5t+ ?is p>agraph1 ! ,adm9i/rator %all take measures to-- 7i7 limit ! pot5tial = duplication 9 report+ requirem5ts2 7ii7 m9imize ! impact ( ! rules on small manufactur]s & processors2 & 7iii7 apply any report+ requirem5ts 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 a rule promulgat$ "u ?is subsection4 2 7#b7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#c7 ,*emical sub/ances 9 comm]ce 7,a7 ,rule 7i7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! ,adm9i/rator %all by rule require manufactur]s & processors to notify ! ,adm9i/rator1 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 prior to ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 7ii7 ,consid]ation z active sub/ance ,! ,adm9i/rator %all consid] *emical sub/ances = :i* notices are receiv$ "u clause 7i7 to be active sub/ances & %all1 pursuant to p>agraph 7#d77;,c71 designate ! *emical sub/ance z an active sub/ance on ! li/ publi%$ "u p>agraph 7#a74 7,b7 ,confid5tial *emical sub/ances 7i7 ,9 g5]al ,! ,adm9i/rator %all ma9ta9 ! li/ "u p>agraph 7#a71 :i* %all include a confid5tial portion & a nonconfid5tial portion consi/5t ) ?is section & section #ad4 7ii7 ,exi/+ claim ( confid5tiality ,! rule promulgat$ "u subp>agraph 7,a7 %all require 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 #ad4 7iii7 ,sub/antiation ,! rule promulgat$ "u subp>agraph 7,a7 %all require ! sub/antiation ( a claim describ$ 9 clause 7ii7 pursuant to section #ad & 9 accordance ) ! review plan describ$ 9 subp>agraph 7,c74 7,c7 ,review plan & requirem5ts 7i7 ,9 g5]al ,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 develop a plan to review all claims to protect ! specific id5tity ( a *emical sub/ance on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 t is id5tifi$ z an active sub/ance 9 a report submitt$ pursuant to subp>agraph 7,a7 or id5tifi$ z active sub/ances "u p>agraph 7#d77;,a74 7ii7 ,cont5ts ,! plan %all describe h[ ! ,adm9i/rator w c>ry out ! requirem5ts ( ?is subp>agraph4 7iii7 ,requirem5ts ,! ,adm9i/rator %all-- 7,i7 require1 at a "t det]m9$ by ! ,adm9i/rator1 all manufactur]s or processors ass]t+ a claim "u subp>agraph 7,b7 to sub/antiate ea* su* claim unless ! manufactur] or processor has sub/antiat$ ! claim 9 a submission made to ! ,adm9i/rator )9 #e ye>s ( ! date ( ! ,adm9i/rator's reque/2 7,,ii7 9 accordance ) ! requirem5ts ( section #ad-- 7aa7 review ea* sub/antiation-- 7,,aa7 submitt$ pursuant to subclause 7,i7 to det]m9e if ! claim w>rants protection f disclosure2 & 7,,bb7 submitt$ previ\sly by a manufactur] or processor & reli$ on 9 lieu ( ! sub/antiation requir$ pursuant to subclause 7,i71 if su* sub/antiation has n be5 previ\sly review$ by ! ,adm9i/rator1 to det]m9e if ! claim w>rants protection f disclosure2 7bb7 approve1 modify or d5y ea* claim2 & 7cc7 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>s unless-- 7,,aa7 prior to ! expiration ( ! p]iod1 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case1 ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7,,bb7 prior to ! expiration ( ! p]iod1 ! ,adm9i/rator o!rwise becomes aw>e t ! ne$ = protection f disclosure c no long] be sub/antiat$1 9 :i* case ! ,adm9i/rator %all take ! actions describ$ 9 subsection 7g77#b72 & 7,,iii7 enc\rage manufactur]s & processors t h previ\sly made claims to protect ! specific id5tities ( *emical sub/ances id5tifi$ z inactive pursuant to p>agraph 7#d77;,b7 to review & ei!r )draw or sub/antiate su* claims4 7,d7 ,timel9e = completion ( reviews 7i7 ,9 g5]al ,! ,adm9i/rator %all 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 ,ext5sion ,! ,adm9i/rator may ext5d ! deadl9e = completion ( ! reviews describ$ 9 subp>agraph 7,c7 = up to a maximum ( #b additional ye>s1 aft] an adequate public ju/ification1 if ! ,adm9i/rator f9ds ! ext5sion is necess>y bas$ on ! numb] ( su* claims ne$+ review & ! available res\rces4 7iii7 ,annual goal ,! ,adm9i/rator %all publi% an annual goal = ! numb] ( reviews to be complet$ ov] ! c\rse ( implem5tation ( ! plan4 7,e7 ,no confid5tiality = unli/$ *emicals ,! specific id5tity ( any *emical t is n on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 or subsequ5tly add$ to ! confid5tial portion ( ! li/ pursuant to section #ad %all n be eligible = protection f disclosure4 7,f7 ,c]tification ,! ,adm9i/rator %all require a manufactur] or processor-- 7i7 to c]tify ! accuracy ( ea* report submitt$ or record ma9ta9$ "u ?is section2 & 7ii7 to reta9 docum5tation support+ c]tification "u clause 7i7 = a p]iod ( #e ye>s beg9n+ on ! la/ day ( ! submission p]iod4 7#d7 ,active & inactive sub/ances 7,a7 ,active sub/ances ,= ! purposes ( ?is section1 ! t]m active sub/ance means a *emical sub/ance t-- 7i7 has be5 manufactur$ or process$ = a nonexempt comm]cial purpose at any po9t dur+ ! #aj-ye> p]iod prior to ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act2 or 7ii7 t is add$ to ! li/ publi%$ "u p>agraph 7#a7 aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 7,b7 ,inactive sub/ances ,= purposes ( ?is section1 ! t]m inactive sub/ance means a *emical sub/ance on ! li/ publi%$ "u p>agraph 7#a7 t does n meet any ( ! crit]ia 9 subp>agraph 7,a74 7,c7 ,li/ ( designations ,! ,adm9i/rator %all ma9ta9 & keep curr5t designations ( active & inactive sub/ances on ! li/ publi%$ "u p>agraph 7#a74 7,d7 ,update ,! ,adm9i/rator %all update ! li/ ( *emicals designat$ z active z soon z practicable foll[+ ! publication ( ! mo/ rec5t data report$ "u "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations1 & ! rule promulgat$ "u subsection 7a77#d74 7,e7 ,*ange to active /atus 7i7 ,9 g5]al ,any p]son :o int5ds to manufacture or process = a nonexempt comm]cial purpose a *emical sub/ance t is designat$ z an inactive sub/ance %all notify ! ,adm9i/rator n less ?an #ij days be=e ! date on :i* ! sub/ance is manufactur$ or process$4 7ii7 ,confid5tial *emical id5tity claims 7,i7 ,9 g5]al ,if a p]son submitt+ a notice "u clause 7i7 = an inactive *emical sub/ance on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 seeks to ma9ta9 an exi/+ claim = protection aga9/ disclosure ( ! specific id5tity ( ! sub/ance z confid5tial1 ! p]son %all-- 7aa7 9 ! notice submitt$ "u clause 7i71 ass]t ! claim2 & 7bb7 sub/antiate ! claim4 7,,ii7 ,no confid5tiality = unli/$ *emicals ,! specific id5tity ( any inactive *emical t is n on ! confid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 or subsequ5tly add$ to ! confid5tial portion ( ! li/ pursuant to section #ad %all n be eligible = protection f disclosure4 7iii7 ,active /atus ,aft] receiv+ notification "u clause 7i71 ! ,adm9i/rator %all-- 7,i7 designate ! *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 ( ! sub/ance & approve1 modify1 or d5y ! claim2 7,,iii7 except z provid$ 9 ?is section & section #ad1 protect f disclosure in=mation = :i* ! ,adm9i/rator approves a claim "u subclause 7,,ii7 = a p]iod ( #aj ye>s unless-- 7aa7 prior to ! expiration ( ! #aj-ye> p]iod1 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case1 ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 or 7bb7 prior to ! expiration ( ! #aj-ye> p]iod1 ! ,adm9i/rator o!rwise becomes aw>e t ! ne$ = protection f disclosure c no long] be sub/antiat$1 9 :i* case ! ,adm9i/rator %all take ! actions describ$ 9 subsection 7g77#b72 & 7,,iv7 pursuant to section #d;,a1 review ! priority ( ! *emical sub/ance z ! ,adm9i/rator det]m9es necess>y4 7,f7 ,category /atus ,! li/ ( inactive *emical sub/ances %all n be consid]$ a category = purposes ( section #bf7;c74 7#e7 ,int]im li/ ( active sub/ances ,prior to ! promulgation ( ! rule requir$ "u ?is subsection1 ! ,adm9i/rator %all designate ^? sub/ances report$ "u "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations1 dur+ ! report+ p]iod t mo/ closely prec$$ ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 z ! initial li/ ( active sub/ances = ! purposes ( section #d;,a4 7#f7 ,public p>ticipation ,! ,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 an active sub/ance2 7,b7 ! specific id5tity ( ea* *emical sub/ance on ! nonconfid5tial portion ( ! li/ publi%$ "u p>agraph 7#a7 t ! ,adm9i/rator has designat$ z an inactive sub/ance2 7,c7 ! 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,d7 subject to section #ad1 ! specific id5tity ( any active sub/ance-- 7i7 = :i* no claim ( protection aga9/ disclosure ( ! specific id5tity pursuant to ?is subsection 0 receiv$2 7ii7 = :i* a claim = protection aga9/ disclosure ( ! specific id5tity ( ! sub/ance has be5 d5i$ by ! ,adm9i/rator2 or 7iii7 = :i* ! "t p]iod = protection aga9/ disclosure ( ! specific id5tity ( ! sub/ance has expir$2 & 7,e7 any sub/ance previ\sly classifi$ z an inactive sub/ance t has be5 reclassifi$ z an active sub/ance4 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 4 #aaj4 ,relation%ip to o!r ,f$]al laws ,section #i 7#ae ,u4,s4,c4 #bfjh7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! fir/ s5t5ce ( p>agraph 7#a7-- 7i7 by /rik+ pres5ts or w pres5t an unreasonable risk to heal? or ! environm5t & ins]t+ does n meet ! safety /&>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+ subsections 7b7 or 7c7 ( section #f1 or section #g2 & 7,c7 9 p>agraph 7#c71 by /rik+ section #f or #g & ins]t+ section #f7;d7 or section #g2 & 7#b7 9 subsection 7d71 9 ! fir/ s5t5ce1 by /rik+ ,heal?1 ,education1 & ,welf>e & ins]t+ ,heal? & ,human ,s]vices4 #aaa4 ,rese>*1 developm5t1 collection1 dissem9ation1 & utilization ( data ,section #aj 7#ae ,u4,s4,c4 #bfji7 is am5d$ by /rik+ ,heal?1 ,education1 & ,welf>e ea* place x appe>s & ins]t+ ,heal? & ,human ,s]vices4 #aab4 ,exports ,section #ab 7#ae ,u4,s4,c4 #bfaa7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ,exception ,p>agraph 7#a7 %all n apply to any *emical sub/ance1 mixture1 or article t ! ,adm9i/rator det]m9es-- 7,a7 "u section #e is n likely to meet ! safety /&>d2 or 7,b7 "u section #f does n meet ! safety /&>d4 7#c7 ,waiv]s ,= a mixture or article conta9+ a *emical sub/ance describ$ 9 p>agraph 7#b71 ! ,adm9i/rator may-- 7,a7 det]m9e t p>agraph 7#a7 %all n apply to ! mixture or article if ! ,adm9i/rator f9ds t ! *emical sub/ance z conta9$ 9 ! mixture or article w meet ! safety /&>d2 & 7,b7 e/abli% a ?re%old conc5tration ( ! *emical sub/ance 9 a mixture or article at :i* p>agraph 7#a7 %all n apply if ! ,adm9i/rator f9ds t at or bel[ ?is conc5tration ! sub/ance z conta9$ 9 ! article or mixture w meet ! safety /&>d4 7#d7 ,te/+ ,! ,adm9i/rator may require te/+ "u section #d ( any *emical sub/ance or mixture exempt$ f ?is ,act by p>agraph 7#a7 = ! purpose ( det]m9+ :e!r or n ! 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 notification1 prohibition1 or 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 notification1 prohibition1 or 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 re/riction pursuant to a rule1 ord]1 or cons5t agreem5t 9 effect "u ?is ,act2 7,e7 a *emical sub/ance or mixture = :i* ! submission ( in=mation is requir$ "u section #d2 or 7,f7 a *emical sub/ance or mixture conta9+ a *emical sub/ance ) respect to :i* an action is p5d+1 or relief has be5 grant$ "u section #g4 7#b7 ,regulations 7,a7 ,9 g5]al ,! ,adm9i/rator %all promulgate regulations to c>ry out p>agraph 7#a74 7,b7 ,cont5ts ,! regulations promulgat$ "u subp>agraph 7,a7 %all include any exemptions ! ,adm9i/rator det]m9es to be appropriate1 :i* may include exemptions id5tifi$ "u section #e7;g74 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 p>agraph 7#a77;,e71 a notice ( availability ( ! in=mation on ! *emical sub/ance or mixture submitt$ to ! ,adm9i/rator2 7,b7 = a *emical sub/ance or mixture describ$ 9 subp>agraph 7,a71 7,b7 or 7,d7 ( p>agraph 7#a71 a notice ( ! det]m9ation1 rule1 ord]1 cons5t agreem5t1 requirem5t1 designation1 action1 or relief2 & 7,c7 = a *emical sub/ance describ$ 9 p>agraph 7#a77;,c71 a notice t satisfies ! obligation ( ! ,unit$ ,/ates "u ! applicable treaty4 2 & 7#c7 9 subsection 7c7-- 7,a7 by /rik+ p>agraph 7#c72 & 7,b7 by r$esignat+ p>agraphs 7#d7 ?r\gh 7#f7 z p>agraphs 7#c7 ?r\gh 7#e71 respectively4 #aac4 ,imports ,section #ac 7#ae ,u4,s4,c4 #bfab7 is am5d$ 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]$ = entry if-- 7,a7 ! ,adm9i/rator-- 7i7 has det]m9$ "u section #f7;c7 t ! *emical sub/ance1 mixture or article does n meet ! safety /&>d2 & 7ii7 has promulgat$ a rule "u section #f7;d7 bann+ ! *emical sub/ance1 mixture1 or article1 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 ! li/ "u section #h7;b77#a7 by ?is title or a rule issu$ by ! ,adm9i/rator "u ?is title2 or 7,c7 ! *emical sub/ance1 mixture1 or any article conta9+ ! *emical sub/ance or mixture fails to comply ) any requirem5t 9 effect "u ?is ,act or is (f]$ = entry 9 violation ( a rule1 cons5t agreem5t1 or ord] 9 effect "u ?is ,act or 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 9 ! #ij-;day p]iod beg9n+ on ! date ( receipt ( ! notice ( ! refus$ entry4 7,b7 ,exception 7i7 ,9 g5]al ,! ,secret>y ( ,homel& ,security may1 p5d+ a review by ! ,adm9i/rator1 release to ! consignee ! *emical sub/ance or mixture if ! consignee-- 7,i7 executes a bond = ! am\nt ( ! full invoice ( ! *emical sub/ance or mixture 7z set =? 9 ! cu/oms entry72 & 7,,ii7 pays a duty on ! *emical sub/ance or mixture4 7ii7 ,adm9i/ration ,if a consignee fails to return a *emical sub/ance or mixture releas$ to t consignee "u clause 7i7 = any cause to ! cu/ody ( ! ,secret>y ( ,homel& ,security :5 dem&$1 ! consignee %all be liable to ! ,unit$ ,/ates = liquidat$ damages equal to ! full am\nt ( ! bond4 7,c7 ,/orage ,all *>ges = /orage1 c>tage1 & labor on & = ! disposal ( a *emical sub/ance or mixture t is refus$ entry or releas$ "u ?is subsection %all be paid by ! own] or consignee1 & a default on t paym5t %all con/itute a li5 aga9/ any future entry made by ! own] or consignee4 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 ! *emical sub/ance or mixture is 9 compliance ) any applicable rule1 cons5t agreem5t1 or ord] "u section #e or #f1 & t ! *emical sub/ance-- 7,a7 is includ$ on ! li/ "u section #h7;b77#a72 or 7,b7 is exempt f any requirem5t to be includ$ on ! li/ "u section #h7;b77#a7 by ?is title or a rule issu$ by ! ,adm9i/rator "u ?is title4 7#b7 ,articles ,! ,adm9i/rator may1 by rule1 require c]tification "u p>agraph 7#a7 = an article conta9+ a *emical sub/ance or mixture t is subject to regulation "u section #e or #f4 7#c7 ,cont5t ( c]tification rule ,9 det]m9+ ! ne$ = & cont5t ( a c]tification rule "u ?is subsection1 ! ,adm9i/rator may consid]-- 7,a7 ! utility ( su* c]tification to ! en=cem5t ( ! applicable rule1 cons5t agreem5t1 or ord] "u section #e or #f2 7,b7 ! frequ5cy ( ! c]tification requirem5t2 & 7,c7 if applicable1 specification ( ! conc5tration ( a *emical sub/ance 9 an article t w\ld subject ! article to ! c]tification requirem5t4 7#d7 ,public in=mation ,= purposes ( ?is section1 ! ,adm9i/rator %all provide publicly accessible in=mation on ! id5tity ( a *emical sub/ance or mixture subject to regulation "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 "o = :i* ! ,unit$ ,/ates is obligat$ to provide export notification by treaty2 or 7#c7 ! *emical sub/ance or *emical sub/ance 9 a mixture is ! subject ( a safety assessm5t & safety det]m9ation conduct$ pursuant to section #f7;d7 & 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 issue rules = ! adm9i/ration ( ?is section4 7#b7 ,cont5t ,a rule issu$ "u p>agraph 7#a7 may tailor ! application ( any requirem5t 9 ?is section1 z appropriate = ! effici5t & effective implem5tation ( ?is ,act4 4 #aad4 ,confid5tial in=mation ,section #ad 7#ae ,u4,s4,c4 #bfac7 is am5d$-- 7#a7 by /rik+ ! head+ ,disclosure ( ,data & ins]t+ ,confid5tial ,in=mation2 7#b7 by /rik+ subsection 7c7 & r$esignat+ subsection 7b7 z subsection 7c72 7#c7 by /rik+ subsection 7a7 & ins]t+ ! foll[+3 #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 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 7#a7 ,9 g5]al ,! in=mation describ$ 9 p>agraph 7#b7 specific to & submitt$ by a manufactur]1 processor1 or di/ributor t meets ! requirem5ts ( subsection 7d7 %all be protect$ f disclosure1 except t-- 7,a7 su* in=mation may be disclos$ 9 accordance ) subsection 7e72 7,b7 su* in=mation is subject to ! review & sub/antiation requirem5ts 9 subsection 7f77#b72 & 7,c7 no?+ 9 ?is ,act %all op]ate to prohibit ! disclosure ( su* in=mation ?r\gh discov]y1 subpo5a1 o!r c\rt ord]s1 or any o!r judicial process o!rwise all[$ "u applicable ,/ate or ,f$]al laws4 7#b7 ,protect$ in=mation ,in=mation subject to p>agraph 7#a7 %all include-- 7,a7 specific in=mation describ+ ! processes us$ 9 manufacture or process+ ( a *emical sub/ance1 mixture1 or article2 7,b7 m>ket+ & sales plans & /rategies2 7,c7 in=mation id5tify+ suppli]s or cu/om]s2 7,d7 ! p]c5tages ( ! compon5ts ( a mixture2 7,e7 specific in=mation ab\t ! use1 function1 or application ( a *emical sub/ance or mixture 9 a process1 mixture1 or product2 7,f7 specific production or import volumes ( ! manufactur]1 & specific aggregat$ volumes across manufactur]s if ! ,adm9i/rator det]m9es t disclosure ( ! specific aggregat$ volumes w\ld reveal confid5tial in=mation2 & 7,g7 except z o!rwise provid$ 9 ?is section1 ! specific id5tity ( a *emical sub/ance prior to ! date on :i* x 0 includ$ on ! li/ "u section #h7;b77#a71 includ+ ! *emical "n1 molecul> =mula1 ,*emical ,ab/racts ,s]vice numb]1 & o!r in=mation t w\ld id5tify a specific *emical sub/ance1 if-- 7i7 ! specific id5tity 0 claim$ z confid5tial in=mation at ! "t x 0 submitt$ to ! ,adm9i/rator 9 a notice "u section #e2 7ii7 ! claim has n subsequ5tly be5 )drawn or f\nd by ! ,adm9i/rator n to w>rant protection z confid5tial in=mation "u subsection 7e71 7f77#b71 or 7g72 & 7iii7 ! sub/ance is n an active sub/ance "u section #h7;b77#d7 ( ?is ,act4 2 7#d7 by /rik+ ! head+ ,data f heal? & safety /udies 9 subsection 7c7 7z s r$esignat$7 & ins]t+ ,in=mation n protect$ f disclosure4--,not)/&+ subsections 7a7 & 7b71 ! foll[+ in=mation %all n be protect$ f disclosure32 7#e7 by ins]t+ at ! end ( subsection 7c7 7z s r$esignat$7 ! foll[+3 7#c7 ,o!r in=mation n protect$ f disclosure ,in=mation %all n be protect$ f disclosure "u ?is section if x is-- 7,a7 = in=mation submitt$ aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 ! specific id5tity ( a *emical sub/ance z ( ! date on :i* x is includ$ on ! li/ "u section #h7;b77#a71 if ! p]son submitt+ ! in=mation does n meet ! requirem5ts ( subsection 7d72 7,b7 a safety assessm5t develop$ or a safety det]m9ation made "u section #f2 7,c7 g5]al in=mation describ+ ! manufactur+ volumes1 express$ z specific aggregat$ volumes or1 :5 ! ,adm9i/rator det]m9es t disclosure ( specific aggregat$ volumes w\ld reveal confid5tial in=mation1 express$ 9 ranges2 or 7,d7 g5]al descriptions ( ! processes 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 w\ld be cu/om>ily %>$ ) ! g5]al public or )9 an indu/ry or indu/ry sector4 7#d7 ,exception ,in=mation elem5ts t are o!rwise eligible = protection "u ?is section t are conta9$ 9 submissions ( in=mation describ$ 9 p>agraph 7#a7 %all be protect$ f disclosure if ! submitt] complies ) subsection 7d71 b in=mation 9 su* submissions describ$ 9 p>agraph 7#a7 t is n eligible = protection aga9/ disclosure %all be disclos$4 7#e7 ,no confid5tiality = unli/$ *emicals ,except z provid$ 9 ! second s5t5ce ( p>agraph 7#a71 ! specific id5tity ( any *emical t is n on ! confid5tial portion ( ! li/ publi%$ "u section #h7;b77#a7 or subsequ5tly add$ to ! confid5tial portion ( ! li/ pursuant to ?is section %all n be eligible = protection f disclosure4 7#f7 ,ban or phase-out ,if ! ,adm9i/rator promulgates a rule pursuant to section #f7;d7 t e/abli%es a ban or phase out on ! manufacture1 process+1 or di/ribution 9 comm]ce ( a *emical sub/ance1 any protection f disclosure provid$ "u section #ad applicable = in=mation on ! *emical sub/ance %all no long] apply & ! ,adm9i/rator %all promptly 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 a claim = su* protection to ! ,adm9i/rator at ! "t ( ! submission ( ! in=mation1 pursuant to rules applicable to a claim = protection f disclosure t ! ,adm9i/rator has promulgat$ "u ?is title4 7,b7 ,cont5ts ( claim ,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$1 or o!rwise made available1 to ! public "u any o!r ,f$]al law 9 connection ) #a or m uses subject to ?is ,act2 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 o!rwise publicly available or 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 ! conditions t-- 7i7 ! g5]ic "n con=ms ) guidance prescrib$ by ! ,adm9i/rator "u p>agraph 7#c77;,a72 & 7ii7 describes ! *emical /ructure ( ! sub/ance z specifically z possible :ile protect+ ^? features ( ! *emical /ructure t are consid]$ confid5tial & ! disclosure ( :i* w\ld pot5tially h>m ! competitive position ( ! p]son4 7#b7 ,additional requirem5ts = confid5tiality claims ,except = in=mation describ$ 9 subsection 7b77#b71 a p]son ass]t+ a claim to protect in=mation f disclosure "u ?is ,act %all1 9 accordance ) ! rules promulgat$ & guidance issu$ by ! ,adm9i/rator1 sub/antiate t ! in=mation meets ! requirem5ts = protection pursuant to section #eeb ( title #e1 ,unit$ ,/ates ,code1 "u subsection 7b77#d7 ( t section4 7#c7 ,guidance ,! ,adm9i/rator %all develop guidance on-- 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#e7 & 7#f7 ( subsection 7e74 7#d7 ,c]tification ,an au?oriz$ (ficial ( ! p]son describ$ 9 p>agraph 7#a77;,a7 %all c]tify t ! /atem5ts & in=mation includ$ 9 ass]tions & sub/antiations ( claims = protection submitt$ "u ?is subsection are true & correct4 7e7 ,exceptions to protection f disclosure ,in=mation describ$ 9 subsection 7a7 7includ+ in=mation subject to subsection 7b77 %all be disclos$ if-- 7#a7 ! in=mation is to be disclos$ to an (fic] or employee ( ! ,unit$ ,/ates 9 connection ) ! (ficial duties ( t p]son "u any law = ! protection ( human heal? or ! environm5t or = specific law en=cem5t purposes2 7#b7 ! in=mation is to be disclos$ to a contractor ) ! ,unit$ ,/ates & employees ( t contractor if1 9 ! op9ion ( ! ,adm9i/rator1 ! disclosure is necess>y = ! satisfactory p]=mance by ! contractor ( a contract ) ! ,unit$ ,/ates = ! p]=mance ( "w 9 connection ) ?is ,act & "u su* conditions z ! ,adm9i/rator %all specify2 7#c7 ! ,adm9i/rator det]m9es t disclosure is necess>y to protect human heal? or ! environm5t2 7#d7 ! in=mation is to be disclos$ to a ,/ate or political subdivision ( a ,/ate1 on writt5 reque/1 = ! purpose ( developm5t1 adm9i/ration1 or en=cem5t ( a law1 if-- 7,a7 #a or m applicable agreem5ts ) ! ,adm9i/rator t con=m ) ! guidance issu$ "u subsection 7d77#c77;,b7 ensure t ! recipi5t gov]nm5t w take appropriate /eps1 & has adequate au?ority1 to ma9ta9 ! confid5tiality ( ! in=mation 9 accordance ) proc$ures comp>able to ^? :i* ! ,adm9i/rator uses to safegu>d ! in=mation2 & 7,b7 ! ,adm9i/rator notifies ! p]son :o submitt$ ! in=mation t ! in=mation has be5 disclos$ to a ,/ate or political subdivision ( a ,/ate2 7#e7 a heal? 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/rator t con=ms ) ! guidance issu$ "u subsection 7d77#c77;,b71 subject to ! conditions t-- 7,a7 ! writt5 /atem5t ( ne$ is a /atem5t t ! p]son has a reasonable basis to suspect t-- 7i7 ! in=mation is necess>y = or w assi/ 9 diagnosis or treatm5t ( #a or m individuals or 9 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$2 & 7,b7 ! confid5tiality agreem5t provides t ! p]son w n use ! in=mation = any purpose o!r ?an ! heal? or environm5tal ne$s ass]t$ 9 ! /atem5t ( ne$1 except z may o!rwise be au?oriz$ by ! t]ms ( ! agreem5t or by ! p]son submitt+ ! in=mation to ! ,adm9i/rator1 except t no?+ 9 ?is ,act %all op]ate to prohibit ! disclosure ( su* in=mation ?r\gh discov]y1 subpo5a1 & o!r c\rt ord]s1 or any o!r judicial process o!rwise all[$ "u applicable ,/ate or ,f$]al laws2 7#f7 9 ! ev5t ( an em]g5cy1 a treat+ physician1 nurse1 ag5t ( a poison control c5t]1 public heal? or environm5tal (ficial ( a ,/ate or political subdivision ( a ,/ate1 or fir/ respond] reque/s ! in=mation1 subject to ! conditions t-- 7,a7 ! treat+ physician1 nurse1 ag5t1 public heal? or environm5tal (ficial ( a ,/ate or a political subdivision ( a ,/ate1 or fir/ respond] has a reasonable basis to suspect t-- 7i7 a m$ical or public heal? or environm5tal em]g5cy exi/s2 7ii7 ! in=mation is necess>y = or w assi/ 9 em]g5cy or fir/-aid diagnosis or treatm5t2 & 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] provides a writt5 /atem5t ( ne$ & agrees to sign a confid5tiality agreem5t z describ$ 9 p>agraph 7#e72 & 7,c7 ! writt5 confid5tiality agreem5t or /atem5t ( ne$ is submitt$ z soon z practicable1 b n necess>ily be=e ! in=mation is disclos$2 7#g7 ! ,adm9i/rator det]m9es t disclosure is relevant 9 a proce$+ "u ?is ,act1 subject to ! condition t ! disclosure is made 9 su* a mann] z to pres]ve confid5tiality to ! maximum ext5t practicable )\t impair+ ! proce$+2 7#h7 ! in=mation is to be disclos$1 on writt5 reque/ ( any duly au?oriz$ committee ( ! ,congress1 to t committee2 7#i7 ! in=mation is publicly available2 or 7#aj7 ! in=mation is requir$ to be disclos$ or o!rwise made public "u any o!r ,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#b7 & except z all[$ "u subsection 7e71 ! ,adm9i/rator %all protect f disclosure in=mation t meets ! requirem5ts ( subsection 7d7 = a p]iod ( #aj ye>s1 unless-- 7i7 prior to ! expiration ( ! #aj-ye> p]iod1 ! p]son notifies ! ,adm9i/rator t ! p]son is )draw+ ! confid5tiality claim1 9 :i* case1 ! ,adm9i/rator %all promptly make ! in=mation available to ! public2 7ii7 prior to ! expiration ( ! #aj-ye> p]iod1 ! ,adm9i/rator o!rwise becomes aw>e t ! ne$ = protection f disclosure c no long] be sub/antiat$1 9 :i* case ! ,adm9i/rator %all take ! actions describ$ 9 subsection 7g77#b72 or 7iii7 ! ,adm9i/rator d5ies ! claim "u subsection 7g77#a74 7,b7 ,ext5sions 7i7 ,9 g5]al ,n less ?an #fj days prior to ! expiration ( ! p]iod describ$ 9 subp>agraph 7,a71 ! ,adm9i/rator %all provide notice ( ! imp5d+ expiration ( ! p]iod to ! p]son :o ass]t$ ! claim4 7ii7 ,submission to reass]t a claim ,n less ?an #cj days prior to expiration ( ! p]iod describ$ 9 subp>agraph 7,a71 ! p]son reass]t+ ! claim %all submit a /atem5t sub/antiat+1 9 accordance ) subsection 7d77#b71 ! ne$ to ext5d ! p]iod4 7iii7 ,review ,n lat] ?an #cj days ( receipt ( ! /atem5t describ$ 9 clause 7ii71 ! ,adm9i/rator %all-- 7,i7 review ! reque/ & make a det]m9ation z to :e!r ! in=mation = :i* ! reque/ is made cont9ues to meet ! relevant crit]ia e/abli%$ 9 ?is section2 & 7,,ii7 7aa7 grant an ext5sion n to exce$ #aj ye>s2 or 7bb7 d5y ! claim4 7,c7 ,limit on numb] ( ext5sions ,!re %all be no limit on ! numb] ( ext5sions grant$ "u subp>agraph 7,b7 z long z ! ,adm9i/rator f9ds t ! sub/antiation e/abli%es ! ne$ to ext5d ! p]iod & meets ! requirem5ts e/abli%$ by ! ,adm9i/rator1 & t ! l5g? ( any ext5sion does n exce$ #aj ye>s4 7#b7 ,review & resub/antiation 7,a7 ,9 g5]al ,! ,adm9i/rator may at any "t review a claim = protection aga9/ disclosure "u subsection 7a7 = in=mation submitt$ to ! ,adm9i/rator on a *emical sub/ance 7includ+ in=mation describ$ 9 subsection 7b77#b771 & may require any p]son :o has claim$ protection = t in=mation1 :e!r be=e or aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act1 to )draw or reass]t & sub/antiate or resub/antiate ! claim 9 con=mance ) ! requirem5ts ( ?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#a7 7,b7 or 7,c72 7iii7 = any inactive *emical sub/ance id5tifi$ pursuant to section #h7;b77#d72 7iv7 if ! ,adm9i/rator det]m9es t disclosure ( c]ta9 in=mation curr5tly protect$ f disclosure w\ld assi/ ! ,adm9i/rator 9 conduct+ safety assessm5ts & det]m9ations "u section #f 7b7 & 7c7 or promulgat+ rules "u section #f7;d72 7v7 if necess>y to comply ) a reque/ = in=mation ! ,adm9i/rator receives pursuant to section #eeb ( title #e1 ,unit$ ,/ates ,code2 7vi7 if in=mation available to ! ,adm9i/rator provides a basis t ! requirem5ts ( subsection 7b77#d7 ( section #eeb ( title #e1 ,unit$ ,/ates ,code1 are no long] met2 or 7vii7 = in=mation conta9$ 9 a notice ( sub/antial risk submitt$ "u section #h7;e74 7,b7 ,resub/antiation ,if ! ,adm9i/rator makes a reque/ "u subp>agraph 7,a71 ! p]son receiv+ ! reque/ %all-- 7i7 resub/antiate ! claim2 or 7ii7 )draw ! claim4 7,c7 ,ext5sion ,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 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]m1 & apply su* id5tifi] consi/5tly to all in=mation relevant to su* sub/ance2 7,b7 annually publi% & update a li/ ( sub/ances = :i* claims to protect specific *emical id5tity f disclosure h be5 approv$1 ref]r$ to by unique id5tifi]1 includ+ ! expiration date = ea* su* claim2 7,c7 ensure t any nonconfid5tial in=mation receiv$ by ! ,adm9i/rator ) respect to su* a sub/ance dur+ ! p]iod ( protection f disclosure is made public & id5tifies ! sub/ance us+ ! unique id5tifi]2 & 7,d7 = ea* claim = protection ( specific *emical id5tity t has be5 d5i$ by ! ,adm9i/rator1 ^u 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 ! 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 :o has submitt$ ! claim fails to meet ! requirem5ts ( subsections 7a7 & 7d74 7ii7 ,reasons = d5ial or modification ,! ,adm9i/rator %all provide to ! p]son :o has submitt$ ! claim 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 on 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 :o 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 :o submitt$ ! reque/ receives notification "u subp>agraph 7,a74 7ii7 ,exceptions 7,i7 ,9 g5]al ,= in=mation "u p>agraph 7#c7 or 7#h7 ( subsection 7e71 ! ,adm9i/rator %all n release t in=mation until ! date t is #ae days aft] ! date on :i* ! p]son :o 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 human heal? or ! environm5t1 9 :i* case1 no prior notification is necess>y4 7,,ii7 ,no notification ,= in=mation "u p>agraph 7#a71 7#b71 7#f71 7#g71 7#i7 or 7#aj7 ( subsection 7e71 no prior notification is necess>y4 7#c7 ,appeals 7,a7 ,9 g5]al ,a p]son :o receives a notification "u p>agraph 7#b7 may1 if ! p]son believes disclosure ( ! in=mation is prohibit$ "u subsection 7a71 be=e ! date on :i* ! in=mation is to be releas$1 br+ an action to re/ra9 disclosure ( ! in=mation 9-- 7i7 ! di/rict c\rt ( ! ,unit$ ,/ates 9 ! di/rict 9 :i* ! 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 prior to ! date on :i* ! applicable c\rt rules on an action "u subp>agraph 7,a74 7#d7 ,adm9i/ration ,9 c>ry+ out ?is subsection1 ! ,adm9i/rator %all employ ! proc$ures 9 "p #b ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations74 7h7 ,crim9al p5alty = wrongful disclosure 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 any (fic] or employee ( ! ,unit$ ,/ates or =m] (fic] or employee ( ! ,unit$ ,/ates :o-- 7,a7 by virtue ( t employm5t or (ficial position has obta9$ possession (1 or has access to1 mat]ial ! disclosure ( :i* is prohibit$ by subsection 7a72 & 7,b7 kn[+ t disclosure ( t mat]ial is prohibit$ by subsection 7a71 willfully discloses ! mat]ial 9 any mann] to any p]son n entitl$ to receive t mat]ial1 %all be guilty ( a misdemeanor & f9$ "u title #ah1 ,unit$ ,/ates ,code1 imprison$ = n m ?an #a ye>1 or bo?4 7#b7 ,o!r laws ,section #aije ( title #ah1 ,unit$ ,/ates ,code1 %all n apply ) respect to ! publi%+1 divulg+1 disclosure1 mak+ kn[n (1 or mak+ available1 in=mation report$ or o!rwise obta9$ "u ?is ,act4 7#c7 ,contractors ,= ! purposes ( ?is subsection1 any contractor ( ! ,unit$ ,/ates :o is furni%$ in=mation 9 accordance ) subsection 7e77#b71 includ+ any employee ( t contractor1 %all be consid]$ to be an employee ( ! ,unit$ ,/ates4 7i7 ,applicability 7#a7 ,except z o!rwise provid$ by ?is section1 section #h1 or any o!r ,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 prior to ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,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 prior to ! effective date ( rules applicable to su* claims t ! ,adm9i/rator may promulgate aft] ! date ( enactm5t ( ! ,alan ,re9/e9 & ,trevor ,s*aef] ,toxic ,*emical ,protection ,act4 7j7 ,def9ition ( fir/ respond] ,= ! purposes ( ?is section1 ! t]m fir/ respond] means a p]son duly au?oriz$ by a ,/ate or political subdivision ( a ,/ate or a ,f$]al ag5cy1 tra9$ 9 urg5t m$ical c>e or o!r em]g5cy proc$ures1 includ+ a police (fic]1 firefight]1 or em]g5cy m$ical te*nician4 4 #aae4 ,prohibit$ acts ,section #ae 7#ae ,u4,s4,c4 #bfad7 is am5d$ by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 fail or refuse to comply )-- 7,a7 any rule promulgat$1 cons5t agreem5t ent]$ into1 or ord] issu$ "u section #d2 7,b7 any requirem5t prescrib$ by section #e or #f2 7,c7 any rule promulgat$1 cons5t agreem5t ent]$ into1 or ord] issu$ "u section #e or #f2 7,d7 any requirem5t ( title ,,ii or any rule promulgat$ or ord] issu$ "u title ,,ii2 or 7,e7 any requirem5t ( title ,,vi or any rule promulgat$ or ord] issu$ "u title ,,vi2 4 #aaf4 ,p5alties ,section #af 7#ae ,u4,s4,c4 #bfae7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 ! fir/ s5t5ce-- 7,i7 by ins]t+ ?is ,act or a rule or ord] promulgat$ or issu$ pursuant to ?is ,act1 z describ$ 9 aft] a provision (2 & 7,,ii7 by /rik+ #be1jjj & ins]t+ #cg1ejj2 & 7ii7 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 & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,any p]son 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 ,any p]son :o kn[+ly or willfully violates any provision ( ?is ,act1 & :o kn[s at ! "t ( ! violation t ! violation places ano!r p]son 9 imm95t dang] ( dea? or s]i\s bodily injury %all be subject1 ^u conviction1 to a f9e ( n m ?an #bej1jjj1 imprisonm5t = n m ?an #ae ye>s1 or bo?4 ,any p]son committ+ su* violation :i* is an organization %all1 ^u conviction "u ?is p>agraph1 be subject to a f9e ( n m ?an #a1jjj1jjj = ea* violation4 7#c7 ,k ( imm95t dang] or injury ,9 det]m9+ :e!r a def5dant knew t ! violation plac$ ano!r p]son 9 imm95t dang] ( dea? or s]i\s bodily injury1 ! def5dant is responsible only = actual aw>5ess or actual belief possess$1 & k possess$ by ano!r p]son t is n ! def5dant may n be attribut$ to ! def5dant4 4 #aag4 ,preemption ,section #ah 7#ae ,u4,s4,c4 #bfag7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ 7#a7 ,except z provid$ 9 p>agraph 7#b71 no?+ & ins]t+ ,no?+2 7#b7 by /rik+ subsection 7a77#b72 & 7#c7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,sav+s 7#a7 ,no preemption ( common law or /atutory causes ( action = civil relief or crim9al conduct ,no?+ 9 ?is ,act1 nor any am5dm5t made by ?is ,act1 nor any regulation1 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$y = civil relief1 includ+ ^? = civil damage1 or a p5alty = a crim9al conduct4 7#b7 ,cl>ification ( no preemption ,not)/&+ any o!r provision 9 ?is ,act1 no?+ 9 ?is ,act1 nor any am5dm5ts made by ?is ,act1 %all preempt or preclude any cause ( action = p]sonal injury1 wrongful dea?1 prop]ty damage1 or o!r injury bas$ on neglig5ce1 /rict liability1 products liability1 failure to w>n1 or any o!r legal !ory ( liability "u any ,/ate1 m>itime1 or ,f$]al common law or /atutory !ory4 7#c7 ,no effect on private rem$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 ,no effect on au?ority ( c\rt ,?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 7#d7 ,no preemption ( /ate laws ,no?+ 9 ?is ,act1 nor any am5dm5t made by ?is ,act1 nor any regulation1 requirem5t1 /&>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 regulation1 requirem5t1 /&>d ( p]=mance1 safety det]m9ation1 sci5tific assessm5t1 or any protection = public heal? or ! environm5t t is diff]5t f1 or 9 addition to1 any regulation1 requirem5t1 /&>d ( p]=mance1 safety det]m9ation1 or sci5tific assessm5t implem5t$ pursuant to ?is ,act4 4 #aah4 ,judicial review ,section #ai 7#ae ,u4,s4,c4 #bfah7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 subp>agraph 7#a77;,a71 by /rik+ section #d7;a71 #e7;a77#b71 #e7;b77#d71 #f7;a71 #f7;e71 or #h1 or "u title ,,ii or ,,iv & ins]t+ section #d7;a71 #e7;c77#d71 #f7;d71 or #h2 7,b7 9 subp>agraph 7#a77;,b71 by /rik+ subp>agraph 7,a7 & ins]t+ p>agraph 7#a72 & 7,c7 by /rik+ p>agraph 7#c72 & 7#b7 9 subsection 7c7-- 7,a7 9 subp>agraph 7#a77;,b71 by /rik+ clauses 7i7 & 7ii7 & ! la/ s5t5ce ( ! subp>agraph2 7,b7 by r$esignat+ p>agraph 7#a77;,b77iii7 z p>agraph 7#a77;,b77i72 & 7,c7 9 p>agraph 7#a77;,b77i7 z s r$esignat$71 by /rik+ 7,i7 any /atem5t requir$ to be made pursuant to section #f7;c77#a7 ( ?is title1 or 7,,ii74 #aai4 ,citiz5s' petitions ,section #ba 7#ae ,u4,s4,c4 #bfbj7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ an ord] "u section #e7;e7 & ins]t+ an ord] "u section #d1 #e7;c712 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by /rik+ an ord] "u section #e7;e7 & ins]t+ an ord] "u section #d1 #e7;c712 & 7,b7 9 p>agraph 7#d71 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,de novo proce$+ 7i7 ,9 g5]al ,9 an action "u subp>agraph 7,a7 to initiate a proce$+ to issue a rule "u section #d1 #e7;c71 #f7;d71 or #h or an ord] issu$ "u section #d or #e7;c71 ! petition] %all be provid$ an opportunity to h ! petition consid]$ by ! c\rt 9 a de novo proce$+4 7ii7 ,demon/ration 7,i7 ,9 g5]al ,! c\rt %all ord] ! ,adm9i/rator to initiate ! action reque/$ by ! petition] if ! petition] demon/rates to ! satisfaction ( ! c\rt by a prepond]ance ( ! evid5ce t-- 7aa7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule or ord] "u section #d1 ! in=mation available to ! ,adm9i/rator is insuffici5t = ! ,adm9i/rator to p]=m an action describ$ 9 section #d1 #d;,a1 or #f7;b72 7bb7 9 ! case ( a petition to issue an ord] "u section #e7;c71 !re is a reasonable basis to conclude t ! sub/ance is n likely to meet ! safety /&>d2 7cc7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #f7;d71 !re is a reasonable basis to conclude t ! sub/ance w n meet ! safety /&>d2 or 7dd7 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #h1 !re is a reasonable basis to conclude t ! rule is necess>y to require report+ or recordkeep+ to obta9 in=mation relevant to det]m9+ :e!r a sub/ance or mixture may fail to meet ! safety /&>d4 7,,ii7 ,def]m5t ,! c\rt may p]mit ! ,adm9i/rator to def] initiat+ ! action reque/$ by ! petition] until su* "t z ! c\rt prescribes if ! c\rt f9ds t-- 7aa7 ! ext5t ( ! risk to human heal? or ! environm5t alleg$ by ! petition] is less ?an ! ext5t ( risks to human heal? or ! environm5t ) respect to :i* ! ,adm9i/rator is tak+ action "u ?is ,act2 & 7bb7 !re are insuffici5t res\rces available to ! ,adm9i/rator to take ! action reque/$ by ! petition]4 4 #abj4 ,/udies ,section #be 7#ae ,u4,s4,c4 #bfbd7 is repeal$4 #aba4 ,adm9i/ration ,section #bf7;e7 7#ae ,u4,s4,c4 #bfbe7;e77 is am5d$-- 7#a7 by /rik+ ,heal?1 ,education1 & ,welf>e ea* place x appe>s & ins]t+ ,heal? & ,human ,s]vices2 & 7#b7 by /rik+ subsection 7b7 & ins]t+-- 7b7 ,fees 7#a7 ,9 g5]al ,! ,adm9i/rator %all1 by rule1 require manufactur]s ( *emical sub/ances to pay reasonable fees to defray ! co/s ( adm9i/]+ ?is title1 includ+ b n limit$ to co/s result+ f-- 7,a7 issu+ rules & ord]s to conduct te/+ "u section #d & review+ data submitt$ "u ^! requirem5ts2 7,b7 develop+ ! priority li/ & designat+ sub/ances z high-priority "u section #d;,a2 7,c7 review+ notices submitt$ "u section #e2 7,d7 conduct+ safety assessm5ts & mak+ safety det]m9ations "u section #f2 7,e7 promulgat+ rules & issu+ ord]s to re/rict *emical sub/ances "u section #f2 7,f7 promulgat+ rules & issu+ ord]s to report in=mation & data & ma9ta9 records "u section #h2 & 7,g7 review+ confid5tiality claims "u section #ad4 7#b7 ,apportionm5t 7,a7 ,9 g5]al ,! ,adm9i/rator %all apportion fees among individual manufactur]s 9 relation to ! co/s ( adm9i/]+ ?is title :i* are attributable to ea* manufactur]'s production or importation ( *emical sub/ances subject to action "u sections #d1 #d;,a1 #e1 #f & #h4 7,b7 ,multiple manufactur]s ,if !re is m ?an #a manufactur] ( su* sub/ance1 ! ,adm9i/rator %all provide = ! %>+ ( fees 9 proportion to ea* manufactur]'s contribution to total production ( su* sub/ance1 unless !re is "s o!r basis = apportionm5t t bett] reflects consid]ations ( haz>d & exposure4 7#c7 ,small bus9ess conc]ns ,! rule promulgat$ "u p>agraph 7#a7 may set sep>ate fees = manufactur]s ( *emical sub/ances t are small bus9ess conc]ns bas$ on _! ability to pay4 7#d7 ,limitation ,fees collect$ "u ?is subsection %all only be us$ to defray ! co/s ( adm9i/]+ ?is title & n = any o!r purpose4 4 7#e7 ,level ( fees ,! ,adm9i/rator %all ensure t fees are set at a level suffici5t to enable ! ,adm9i/rator to p]=m all ( ! responsibilities describ$ 9 p>agraph 7#a7 & add n less ?an #c *emical sub/ances to ! li/ ( high-priority sub/ances = ea* *emical sub/ance remov$ f ! li/ "u section #d;,a7a77#e77;iii7 & to complete safety assessm5ts & det]m9ations & any necess>y rulemak+ = ^! high-priority sub/ances 9 accordance ) section #f7;a74 4 #abb4 ,developm5t & evaluation ( te/ me?ods ,section #bg7;a7 7#ae ,u4,s4,c4 #bfbf7;a77 is am5d$ by /rik+ ,heal?1 ,education1 & ,welf>e & ins]t+ ,heal? & ,human ,s]vices4 #abc4 ,/ate programs ,section #bh 7#ae ,u4,s4,c4 #bfbg7 is am5d$ by /rik+ subsections 7c7 & 7d74 #abd4 ,au?orization ( appropriations ,section #bi 7#ae ,u4,s4,c4 #bfbh7 is repeal$4 #abe4 ,annual report ,section #cj 7#ae ,u4,s4,c4 #bfbi7 is am5d$ by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 7,a7 ! numb] ( notices receiv$ dur+ ea* ye> "u section #e2 & 7,b7 ! numb] ( ! notices describ$ 9 subp>agraph 7,a7 = *emical sub/ances subject to a rule1 te/+ cons5t agreem5t1 or ord] "u section #d2 4 ,,ii ,/r5g!n+ protections = *ildr5 & communities f disease clu/]s #bja4 ,purposes ,! purposes ( ?is title are-- 7#a7 to provide to ! ,adm9i/rator ! au?ority to help conduct inve/igations into ! pot5tial = environm5tal pollutants or toxic sub/ances to cause disease clu/]s2 7#b7 to ensure t ! ,adm9i/rator has ! au?ority to und]take actions to help address exi/+ & pot5tial environm5tal pollution & toxic sub/ances t may contribute to ! creation ( disease clu/]s2 & 7#c7 to enable ! ,adm9i/rator to integrate & "w 9 conjunction ) o!r ,f$]al1 ,/ate1 & local ag5cies1 in/itutions ( high] education1 & ! public 9 inve/igat+ & help+ to address ! possible causes ( disease clu/]s4 #bjb4 ,def9itions ,9 ?is title3 7#a7 ,adm9i/rator ,! t]m ,adm9i/rator means ! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy4 7#b7 ,ag5cy ,! t]m ,ag5cy means ! ,environm5tal ,protection ,ag5cy4 7#c7 ,director ,! t]m ,director means ! ,director ( ! ,national ,in/itute ( ,environm5tal ,heal? ,sci5ces4 7#d7 ,disease clu/] ,! t]m disease clu/] means-- 7,a7 ! occurr5ce ( a great]-?an-expect$ numb] ( cases ( a p>ticul> disease )9 a gr\p ( individuals1 a geographical area1 or a p]iod ( "t2 or 7,b7 ! occurr5ce ( a p>ticul> disease 9 su* numb] ( cases1 or meet+ su* o!r crit]ia1 z ! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 may det]m9e4 7#e7 ,environm5tal pollutants or toxic sub/ances ,! t]m environm5tal pollutants or toxic sub/ances includes ! sub/ances describ$ 9 p>agraph 7#g74 7#f7 ,f$]al ag5cy ,! t]m ,f$]al ag5cy means-- 7,a7 any dep>tm5t1 ag5cy1 or o!r in/rum5tality ( ! ,f$]al ,gov]nm5t2 7,b7 any indep5d5t ag5cy or e/abli%m5t ( ! ,f$]al ,gov]nm5t 7includ+ any ,gov]nm5t corporation72 & 7,c7 ! ,gov]nm5t ,publi%+ ,(fice4 7#g7 ,pot5tial causes ( a disease clu/] ,! t]m pot5tial causes ( a disease clu/] includes environm5tal & public heal? factors t c\ld increase ! possibility ( disease clu/]s1 includ+ environm5tal pollutants or toxic sub/ances & s\rces ( ^? pollutants & sub/ances1 includ+-- 7,a7 emissions ( air pollutants t are regulat$ "u ! ,clean ,air ,act 7#db ,u4,s4,c4 #gdja et seq472 7,b7 wat] pollutants t are regulat$ "u ! ,f$]al ,wat] ,pollution ,control ,act 7#cc ,u4,s4,c4 #abea et seq472 7,c7 a contam9ant1 z t t]m is def9$ 9 section #adja ( ! ,safe ,dr9k+ ,wat] ,act 7#db ,u4,s4,c4 #cjj;f72 7,d7 a haz>d\s sub/ance1 z t t]m is def9$ 9 section #aja ( ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act 7#db ,u4,s4,c4 #ifja72 7,e7 solid wa/e & haz>d\s wa/e1 z ^? t]ms are def9$ 9 section #ajjd ( ! ,solid ,wa/e ,disposal ,act 7#db ,u4,s4,c4 #fijc72 7,f7 a *emical sub/ance1 z t t]m is def9$ 9 section #c ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjb72 7,g7 a sub/ance t is regulat$ "u ! ,em]g5cy ,plann+ & ,community ,"r-,to-,"k ,act ( #aihf 7#db ,u4,s4,c4 #aajja et seq472 & 7,h7 any o!r =m ( environm5tal pollution or toxic sub/ance t is a kn[n or pot5tial cause ( an adv]se heal? effect1 includ+ a developm5tal1 reproductive1 neurotoxic1 or c>c9og5ic effect4 7#h7 ,regional ,response ,c5t] ,! t]m ,regional ,response ,c5t] means a ,regional ,disease ,clu/] ,in=mation & ,response ,c5t] e/abli%$ "u section #bjd4 7#i7 ,response ,team ,! t]m ,response ,team means a ,regional ,disease ,clu/] ,in=mation & ,response ,team e/abli%$ "u section #bjd4 7#aj7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 #bjc4 ,guidel9es = environm5tal inve/igations ( disease clu/]s 7a7 ,e/abli%m5t 7#a7 ,9 g5]al ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 ! ,secret>y1 & ! ,director1 %all develop1 publi%1 & p]iodically update guidel9es t describe a sy/ematic1 integrat$ approa* t uses ! be/ available sci5ce to inve/igate-- 7,a7 #a or m suspect$ or pot5tial disease clu/]s2 7,b7 environm5tal pollutants or toxic sub/ances associat$ ) #a or m suspect$ or pot5tial disease clu/]s2 or 7,c7 pot5tial causes ( #a or m disease clu/]s4 7#b7 ,coord9ation ,! ,adm9i/rator %all ensure t ! ,(fice ( ,*ildr5's ,heal? ,protection1 9 consultation ) appropriate advisory committees1 su* z ! ,*ildr5's ,heal? ,protection ,advisory ,committee1 has a prom95t role on behalf ( ! ,ag5cy 9 develop+ & updat+ guidel9es "u p>agraph 7#a74 7b7 ,requirem5ts ,guidel9es develop$ "u ?is section %all include-- 7#a7 def9itions ( key concepts & actions2 7#b7 disease clu/] id5tification & report+ protocols2 7#c7 /&>diz$ me?ods ( review+ & categoriz+ data1 includ+ f heal? surveillance sy/ems & disease clu/] reports2 7#d7 guidance = us+1 9 a heal?-protective way1 an appropriate epidemiological1 /ati/ical1 or o!r approa* = ! circum/ances ( an inve/igation2 7#e7 proc$ures = pe] review ( key docum5ts by individuals :o h no direct or indirect conflict ( int]e/2 & 7#f7 a description ( roles & responsibilities ( ! ,adm9i/rator & ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry 9 conduct+ inve/igations describ$ 9 ^? guidel9es1 9 accordance ) ?is title4 7c7 ,tim+ 7#a7 ,9 g5]al ,draft guidel9es develop$ "u ?is section %all be available = public review & comm5t = a p]iod ( n less ?an #fj days4 7#b7 ,f9al guidel9es ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 ! ,secret>y1 & ! ,director1 %all publi% 9 ! ,f$]al ,regi/] f9al guidel9es "u ?is section4 #bjd4 ,enhanc$ support = environm5tal inve/igations ( disease clu/]s 7a7 ,e/abli%m5t ( ,regional ,disease ,clu/] ,in=mation & ,response ,c5t]s & ,teams 7#a7 ,e/abli%m5t 7,a7 ,9 g5]al ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 ! ,secret>y1 & ! ,director1 & o!r appropriate ,f$]al ag5cies1 %all e/abli% & op]ate ,regional ,disease ,clu/] ,in=mation & ,response ,c5t]s & ,regional ,disease ,clu/] ,in=mation & ,response ,teams4 7,b7 ,pr9cipal responsibility ,! ,adm9i/rator %all be pr9cipally responsible = direct+1 coord9at+1 & approv+ ,f$]al ef=ts & assi/ance au?oriz$ "u ?is section4 7#b7 ,coord9ation 7,a7 ,9 g5]al ,! ,adm9i/rator %all ensure t ! ,(fice ( ,*ildr5's ,heal? ,protection1 9 consultation ) appropriate advisory committees1 su* z ! ,*ildr5's ,heal? ,protection ,advisory ,committee1 has a prom95t role on behalf ( ! ,ag5cy 9 e/abli%+ & op]at+ ! ,regional ,response ,c5t]s & ! ,response ,teams4 7,b7 ,grants & coop]ative agreem5ts 7i7 ,9 g5]al ,! ,adm9i/rator %all provide support 7includ+ rese>*1 program implem5tation1 & op]ational support activities7 to individuals on ,response ,teams describ$ 9 subsection 7b7 & ,community ,disease ,clu/] ,advisory ,committees describ$ 9 subsection 7c7 ?r\gh grants & coop]ative agreem5ts ) in/itutions ( high] education t h programs or individuals ) demon/rat$ exp]tise 9 rese>*1 tra9+1 /udies1 & te*nical assi/ance4 7ii7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is subp>agraph su* sums z are necess>y4 7#c7 ,tim+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator %all e/abli% at lea/-- 7,a7 #b ,regional ,response ,c5t]s2 & 7,b7 #b ,response ,teams4 7b7 ,response ,teams 7#a7 ,memb]%ip ,ea* ,response ,team %all include individuals :o-- 7,a7 h exp]tise 9 epidemiology1 toxicog5omics1 molecul> biology1 toxicology1 pollution control requirem5ts1 data analysis1 environm5tal heal? & disease surveillance1 exposure assessm5t1 p$iatric heal?1 community outrea* & involvem5t1 & o!r relevant fields2 & 7,b7 h no direct or indirect conflict ( int]e/4 7#b7 ,lead]%ip ,ea* ,response ,team %all h-- 7,a7 an individual :o is ! lead] ( ! ,response ,team & :o reports to ! ,adm9i/rator1 ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 & ! ,director2 & 7,b7 an individual :o has ! skills or exp]i5ce necess>y to c>ry out community outrea* & involvem5t activities1 includ+-- 7i7 ! e/abli%m5t ( ,community ,disease ,clu/] ,advisory ,committees "u subsection 7c72 & 7ii7 ! facilitation ( activities ( ^? ,committees4 7#c7 ,activities 7,a7 ,9 g5]al ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 %all e/abli% ! scope ( activities = ,response ,teams to ensure t ! activities are consi/5t ) a*iev+ ! purposes ( ?is title4 7,b7 ,requirem5ts ,! activities ( ! ,response ,teams %all include-- 7i7 mak+ guidel9es1 protocols1 data1 & o!r relevant in=mation & exp]tise available to ,/ate & local (ficials & ! public to assi/ 9 ef=ts-- 7,i7 to inve/igate suspect$ or pot5tial disease clu/]s1 environm5tal pollutants or toxic sub/ances associat$ ) ^? disease clu/]s1 & pot5tial causes ( disease clu/]s2 & 7,,ii7 to address pot5tial causes ( disease clu/]s2 7ii7 respond+ rapidly to a petition describ$ 9 subp>agraph 7,c7 f any p]son1 includ+ a ,/ate or local (ficial1 reg>d+ ! ne$-- 7,i7 to inve/igate suspect$ or pot5tial disease clu/]s1 environm5tal pollutants or toxic sub/ances associat$ ) ^? disease clu/]s1 & pot5tial causes ( disease clu/]s2 & 7,,ii7 to address ! pot5tial causes ( disease clu/]s2 7iii7 provid+ ! be/ available environm5tal sampl+ & laboratory equipm5t to collect1 analyze1 & int]pret monitor+1 heal? surveillance1 & o!r relevant in=mation at scales & "tl9es appropriate to an action2 7iv7 involv+ community memb]s1 9 accordance ) e/abli%$ sci5tific me?ods & norms 7includ+ ! pres]vation ( ! confid5tiality ( individuals71 9-- 7,i7 inve/igations ( suspect$ or pot5tial disease clu/]s1 environm5tal pollutants or toxic sub/ances associat$ ) ^? disease clu/]s1 or pot5tial causes ( disease clu/]s1 includ+ ?r\gh-- 7aa7 environm5tal exposure assessm5ts2 7bb7 biomonitor+ activities2 & 7cc7 community-bas$ p>ticipatory rese>* initiatives2 & 7,,ii7 o!r ef=ts to address ! pot5tial causes ( disease clu/]s2 7v7 work+ ) ,/ate & local ag5cies-- 7,i7 to help make ! use & managem5t ( integrat$ environm5tal heal? data consi/5t & timely2 & 7,,ii7 to fill data gaps2 & 7vi7 inve/igat+ suspect$ or pot5tial disease clu/]s1 environm5tal pollutants or toxic sub/ances associat$ ) ^? disease clu/]s1 & pot5tial causes ( disease clu/]s1 & address+ ! pot5tial causes ( disease clu/]s t ! ,adm9i/rator det]m9es ,/ate & local (ficials ne$ assi/ance 9 inve/igat+ or address+1 or t ! ,adm9i/rator det]m9es %\ld be inve/igat$ or address$4 7,c7 ,petition 7i7 ,9 g5]al ,any p]son1 includ+ a ,/ate or local (ficial1 may submit a petition ref]r$ to 9 subp>agraph 7,b77ii7 to ! ,adm9i/rator1 ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 & ! ,director t reque/s t a ,response ,team conduct an inve/igation or take o!r action to address ! pot5tial causes ( disease clu/]s 9 accordance ) ?is title4 7ii7 ,requirem5ts ,ea* petition submitt$ "u clause 7i7 %all cle>ly describe ! basis = ! reque/$ inve/igation or action1 includ+ any data support+ ! reque/4 7iii7 ,consid]ation ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 %all e/abli% crit]ia = ! consid]ation ( petitions submitt$ "u ?is section us+ heal?-protective factors1 includ+-- 7,i7 evid5ce ( ! release ( environm5tal pollutants or toxic sub/ances2 7,,ii7 ! locations 9 :i* !re appe> to be pot5tially significant heal? ?reats f ! pot5tial causes ( disease clu/]s2 7,,iii7 cases 9 :i* exi/+ data appe> to be inadequate to fully assess ! pot5tial risks to public heal?2 & 7,,iv7 su* o!r factors z ! ,adm9i/rator det]m9es are necess>y4 7iv7 ,response ,n lat] ?an #fj days aft] ! date ( receipt ( a petition "u clause 7iii71 ! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 %all provide a writt5 response t describes-- 7,i7 ! inve/igation or actions t w be und]tak5 9 response to ! petition1 includ+ ! timel9e & basis = ! inve/igation or actions2 & 7,,ii7 ! reasons = any d5ial or def]ral 9 provid+ su* a response4 7v7 ,tim+ ( issuance ( crit]ia 7,i7 ,9 g5]al ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 %all provide = public notice ( draft crit]ia e/abli%$ "u ?is subp>agraph = a p]iod ( n less ?an #fj days4 7,,ii7 ,f9al crit]ia ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 %all publi% 9 ! ,f$]al ,regi/] f9al crit]ia requir$ "u ?is subp>agraph4 7#d7 ,use ( publicly available reports ,response ,team inve/igations & actions %all-- 7,a7 include publicly available reports prep>$ by ! ,response ,team t conta9 /atem5ts ( facts1 f9d+s1 & recomm5dations = actions1 to ! ext5t appropriate2 & 7,b7 be prep>$ 9 a mann] t pres]ves ! confid5tiality ( individuals4 7#e7 ,transp>5cy & acc\ntability ,response ,team activities %all include measures to ensure-- 7,a7 transp>5cy & acc\ntability to pot5tially affect$ individuals1 ,/ate & local (ficials1 ! public1 & o!r p]sons & ag5cies1 :ile pres]v+ ! confid5tiality ( individuals2 7,b7 t consi/5t1 accurate1 & mean+ful in=mation is provid$ to pot5tially affect$ individuals1 ,/ate & local (ficials1 ! public1 & o!r p]sons & ag5cies ?r\gh ! use ( compreh5sive1 community-bas$ communications plans2 & 7,c7 acc\ntability to meet+ goals & timetables4 7#f7 ,database 7,a7 ,9 g5]al ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 ! ,secret>y1 & ! ,director1 %all compile & regul>ly update in=mation 9 a compreh5sive electronic database t-- 7i7 is publicly accessible ?r\gh ! ,int]net2 7ii7 provides a c5traliz$ location = in=mation relat+ to-- 7,i7 disease clu/] reports & inve/igations2 7,,ii7 environm5tal pollutants or toxic sub/ances t are associat$ ) suspect$ or pot5tial disease clu/]s2 7,,iii7 illnesses associat$ ) suspect$ or pot5tial disease clu/]s1 includ+ locally g5]at$ in=mation2 7,,iv7 sy/ematic track+ ( environm5tal pollutants or toxic sub/ances & illnesses associat$ ) suspect$ or pot5tial disease clu/]s2 7,v7 actions to help address ! pot5tial causes ( disease clu/]s2 & 7,,vi7 any o!r in=mation t ! ,adm9i/rator det]m9es to be necess>y2 & 7iii7 facilitates ! rapid report+ & analysis ( in=mation describ$ 9 clause 7ii74 7,b7 ,confid5tiality ,a database describ$ 9 subp>agraph 7,a7 %all be ma9ta9$ 9 a mann] t pres]ves ! confid5tiality ( individuals4 7c7 ,community ,disease ,clu/] ,advisory ,committees 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% ,community ,disease ,clu/] ,advisory ,committees to provide ov]sight1 guidance1 & advice relat+ to-- 7,a7 ! inve/igation ( suspect$ & pot5tial disease clu/]s2 7,b7 ! inve/igation ( environm5tal pollutants or toxic sub/ances associat$ ) suspect$ or pot5tial disease clu/]s2 7,c7 ! inve/igation ( pot5tial causes ( disease clu/]s2 7,d7 ef=ts to address ! pot5tial causes ( disease clu/]s2 & 7,e7 ! mo/ effective means ( ensur+ outrea* to & involvem5t ( community memb]s4 7#b7 ,memb]%ip ,memb]%ip on ,community ,disease ,clu/] ,advisory ,committees %all be compris$ ( repres5tatives t include-- 7,a7 individuals :o are or may be impact$ by a suspect$ or pot5tial disease clu/]1 & ! designee ( su* an individual :o may p>ticipate ) or 9 ! place ( su* an individual2 7,b7 ,/ate or local gov]nm5t heal? or environm5tal ag5cies2 7,c7 at lea/ #b individuals1 appo9t$ by ! ,adm9i/rator 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 ) demon/rat$ k ( ! activities describ$ 9 p>agraph 7#a72 & 7,d7 o!r appropriate individuals1 z det]m9$ by ! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director4 7#c7 ,prohibition ,no memb] ( a ,committee may h any direct or indirect conflict ( int]e/4 7#d7 ,te*nical ,assi/ance 7,a7 ,9 g5]al ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry & ! ,director1 may make grants available to any gr\p ( individuals t may be affect$ by a suspect$ or pot5tial disease clu/]4 7,b7 ,use ( funds ,grants made available "u subp>agraph 7,a7 may be us$ to facilitate active involvem5t 9 all aspects ( ,committee activities & to assi/ ,committee memb]s 9 obta9+ te*nical assi/ance 9 int]pret+ in=mation ) reg>d to-- 7i7 ! inve/igation (-- 7,i7 suspect$ or pot5tial disease clu/]s2 7,,ii7 environm5tal pollutants or toxic sub/ances t are associat$ ) suspect$ or pot5tial disease clu/]s2 & 7,,iii7 ! pot5tial causes ( disease clu/]s2 7ii7 address+ ! pot5tial causes ( disease clu/]s2 7iii7 und]/&+ ! heal? conc]ns associat$ ) suspect$ or pot5tial disease clu/]s2 & 7iv7 und]/&+ o!r sci5tific & te*nical issues relat+ to ! activities ( a ,regional ,response ,team & ,community ,disease ,clu/] ,advisory ,committee1 includ+ ! pot5tial ne$ = & int]pretation ( any biomonitor+ ( individuals 9 ! area4 7d7 ,environm5tal rese>* & analysis ,! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 ! ,secret>y1 & ! ,director1 %all use available au?orities & programs to compile1 rese>*1 & analyze in=mation g5]at$ by actions au?oriz$ "u ?is section1 includ+ by-- 7#a7 us+ ^? au?orities to te/ environm5tal pollutants or toxic sub/ances id5tifi$ "u subsection 7b77#f72 & 7#b7 incorporat+ environm5tal pollutants or toxic sub/ances id5tifi$ "u subsection 7b77#f7 9 appropriate national biomonitor+ initiatives4 #bje4 ,f$]al reports to ,congress 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act & annually !reaft]1 ! ,adm9i/rator1 9 consultation ) ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry1 ! ,secret>y1 & ! ,director1 %all prep>e a report t describes-- 7#a7 ! /atus ( activities "u ?is title to inve/igate & address ! suspect$ & pot5tial causes ( disease clu/]s2 7#b7 environm5tal pollutants or toxic sub/ances t are associat$ ) suspect$ or pot5tial disease clu/]s2 7#c7 ! pot5tial causes ( disease clu/]s2 & 7#d7 ways to address ! pot5tial causes ( ^? disease clu/]s4 7b7 ,requirem5ts ,! report %all include a description (-- 7#a7 outrea* activities to ,/ate & local (ficials & communities2 7#b7 actions t ! ,adm9i/rator has tak5 to prioritize ! te/+ ( environm5tal pollutants or toxic sub/ances2 7#c7 actions t ! ,adm9i/rator has tak5 to include environm5tal pollutants or toxic sub/ances id5tifi$ "u section #bjd7;b77#g7 9 appropriate national biomonitor+ initiatives2 7#d7 actions t ! ,adm9i/rator is tak+ or plans to take to address problems 9 implem5t+ ?is title2 7#e7 actions t ! ,secret>y is tak+ or plans to take to address problems 9 implem5t+ ?is title2 7#f7 actions t ! ,adm9i/rator ( ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry has und]tak5 or is consid]+ tak+ ) respect to any disease clu/]s "u subp>agraphs 7,d7 & 7,e7 ( section #ajd7;i77#a7 ( ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act 7#db ,u4,s4,c4 #ifjd7;i77#a77 & o!r provisions ( t section2 7#g7 actions t ! ,director is tak+ or plans to take to address problems 9 implem5t+ ?is title2 & 7#h7 o!r relevant in=mation4 7c7 ,submission & availability ,! ,adm9i/rator %all-- 7#a7 submit ! report "u ?is subsection to-- 7,a7 ! ,committees on ,environm5t & ,public ,works & ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 & 7,b7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7#b7 make ! report available to ! public4 #bjf4 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ su* sums z are necess>y to c>ry out ?is title4 #bjg4 ,effect on o!r law ,no?+ 9 ?is title modifies1 limits1 or o!rwise affects ! application (1 or obligation to comply )1 any law1 includ+ any environm5tal or public heal? law4 ,,iii ,community disease clu/] te*nical assi/ance grants #cja4 ,community disease clu/] te*nical assi/ance grants 7a7 ,9 g5]al ,! ,adm9i/rator ( ! ,environm5tal ,protection ,ag5cy 7ref]r$ to 9 ?is title z ! ,adm9i/rator71 9 coord9ation ) ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is title z ! ,secret>y7 may aw>d grants 9 accordance ) ?is title to any individual or gr\p ( individuals t may be affect$ by a report$ community-bas$ disease clu/]-- 7#a7 to pay ! ,f$]al %>e ( ! te*nical assi/ance describ$ 9 subsection 7d72 7#b7 to protect public heal? & ! environm5t2 7#c7 to promote heal?y & safe environm5ts2 & 7#d7 to prev5t & address h>mful exposures to haz>d\s sub/ances4 7b7 ,application 7#a7 ,9 g5]al ,to be eligible = a grant "u ?is title1 an individual or gr\p ( individuals %all submit to ! ,adm9i/rator & ! ,secret>y an application t conta9s a description ( !-- 7,a7 ne$ = te*nical assi/ance1 includ+ ! ne$ to procure indep5d5t te*nical advisors to help grant recipi5ts int]pret ! in=mation describ$ 9 subsection 7d72 7,b7 expect$ outputs1 includ+ results1 effects1 or consequ5ces t w occur f ! te*nical assi/ance2 & 7,c7 expect$ outcomes1 includ+ activity1 ef=t1 or associat$ "w products t w be produc$ or provid$ ov] a p]iod ( "t or by a specific date4 7#b7 ,response ,n lat] ?an #abj days aft] ! date on :i* an application is submitt$ "u p>agraph 7#a71 ! ,adm9i/rator & ! ,secret>y %all respond to ea* applicant 9 writ+ & describe :e!r ! application is approv$1 d5i$1 or w be consid]$ aft] ! applicant modifies ! application4 7#c7 ,crit]ia ,! ,adm9i/rator1 9 coord9ation ) ! ,secret>y1 %all develop crit]ia t1 if satisfi$1 w\ld result 9 ! ,adm9i/rator & ! ,secret>y accept+ an application submitt$ "u p>agraph 7#a74 7c7 ,am\nt 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ea* grant aw>d$ "u ?is title %all n exce$ #ej1jjj4 7#b7 ,waiv] ,! ,adm9i/rator1 9 coord9ation ) ! ,secret>y1 may waive ! limitation describ$ 9 p>agraph 7#a7 if ! waiv] is necess>y to provide ! te*nical assi/ance describ$ 9 subsection 7d74 7d7 ,use ( funds ,grants aw>d$ "u ?is title %all be us$ to obta9 te*nical assi/ance 9 int]pret+ in=mation reg>d+-- 7#a7 inve/igat+ report$ community-bas$ disease clu/]s associat$ ) #a or m haz>d\s *emicals2 7#b7 ! pot5tial haz>d\s *emicals associat$ ) a report$ community-bas$ disease clu/]2 7#c7 provid+ individuals or gr\ps ( individuals ) community-bas$ tools to educate ! individuals on ! mitigation ( haz>d\s *emicals associat$ ) report$ community-bas$ disease clu/]s2 or 7#d7 o!r sci5tific & te*nical issues relat$ to report$ community-bas$ disease clu/]s4 7e7 ,numb] ( grants ,no individual or gr\p ( individuals %all be aw>d$ m ?an #a grant "u ?is title4 7f7 ,non-,f$]al %>e 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! non-,f$]al %>e = ea* grant aw>d$ "u ?is title is #bj p]c5t4 7#b7 ,waiv] ,! ,adm9i/rator1 9 coord9ation ) ! ,secret>y1 may waive ! non-,f$]al %>e describ$ 9 p>agraph 7#a7 if-- 7,a7 ! recipi5t ( ! grant demon/rates f9ancial ne$2 & 7,b7 ! waiv] is necess>y to provide ! te*nical assi/ance describ$ 9 subsection 7d74 7g7 ,r5ewal ( grant 7#a7 ,9 g5]al ,any grant aw>d$ "u ?is title may be r5ew$ to facilitate te*nical assi/ance to any gr\p ( individuals t may be affect$ by a report$ community-bas$ disease clu/]4 7#b7 ,conditions ,ea* r5ewal ( a grant aw>d$ "u ?is title is subject to ! same conditions t apply to an initial grant4 7h7 ,reports ,any recipi5t ( a grant aw>d$ "u ?is title %all submit to ! ,adm9i/rator & ! ,secret>y a report t describes ! progress 9 address+ ! ne$s & a*iev+ ! outputs & outcomes describ$ 9 subsection 7b74 #cjb4 ,au?orization ( appropriations ,= ea* ( fiscal ye>s #bjaf ?r\gh #bjba1 !re are au?oriz$ to be appropriat$ to ! ,adm9i/rator & ! ,secret>y f any funds made available to ! ,adm9i/rator & ! ,secret>y = ! purpose ( provid+ community memb]s ) te*nical assi/ance & engagem5t on environm5tal heal? issues f ! ,haz>d\s ,sub/ance ,sup]fund e/abli%$ "u section #iejg ( ! ,int]nal ,rev5ue ,code ( #aihf su* sums z are necess>y to c>ry out section #cja4