,,ii #aac? ,,congress #a/ ,session ,s4 #fif ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #aj1 #bjac ,mr4 ,reid 7= ,mr4 ,laut5b]g 7= himself1 ,mrs4 ,gillibr&1 ,mr4 ,s*um]1 ,mr4 ,durb91 ,mrs4 ,murray1 ,mrs4 ,box]1 ,mr4 ,udall ( ,new ,mexico1 ,mr4 ,baucus1 ,ms4 ,mikulski1 ,mr4 ,b5net1 ,ms4 ,klobu*>1 ,mr4 ,frank51 ,mr4 ,te/]1 ,mr4 ,:iteh\se1 ,mrs4 ,fe9/e91 ,mr4 ,blum5?al1 ,mr4 ,c[an1 ,mr4 ,s&]s1 ,ms4 ,w>r51 ,mr4 ,h>k91 ,mr4 ,m]kley1 ,mr4 ,wyd51 ,mr4 ,c>d91 ,mr4 ,leahy1 ,mr4 ,m55dez1 ,mr4 ,s*atz1 ,mr4 ,nelson1 ,ms4 ,cantwell1 & ,mr4 ,k+77 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,environm5t & ,public ,works ,a ,,bill ,to am5d ! ,toxic ,sub/ances ,control ,act to ensure t risks f *emicals are adequately und]/ood & manag$1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safe ,*emicals ,act ( #bjac4 #b4 ,purposes ,! purpose ( ?is ,act is to ensure t risks f *emicals are adequately und]/ood & manag$4 #c4 ,f9d+s1 policy1 & goal ,section #b ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja7 is am5d$-- 7#a7 9 ! head+1 by /rik+ ,int5t & ins]t+ ,goal2 & 7#b7 by /rik+ subsections 7a7 ?r\gh 7c7 & ins]t+ ! foll[+3 7a7 ,f9d+s ,congress f9ds t-- 7#a7 ea* ye> human be+s & ! environm5t are expos$ to a l>ge numb] ( *emical sub/ances2 7#b7 ! *emical indu/ry1 an important "p ( ! ,unit$ ,/ates economy1 provides valuable products t are us$ 9 div]se manufactur+ indu/ries & o!r comm]cial1 in/itutional1 & consum] applications2 7#c7 m ?an #c decades aft] ! enactm5t ( ?is ,act1 p & ! environm5t 9 ! ,unit$ ,/ates are /ill expos$ to ?\s&s ( *emicals ^: safety has n be5 adequately review$ & may h>m heal? & ! environm5t2 7#d7 ! incid5ce ( "s diseases & disord]s l9k$ to *emical sub/ance exposures is on ! rise2 7#e7 biomonitor+ ( *emical sub/ances 9 humans reveals t p 9 ! ,unit$ ,/ates c>ry hundr$s ( haz>d\s *emicals 9 _! bodies2 7#f7 ! conc5trations ( c]ta9 *emical sub/ances t p]si/ & accumulate are increas+ 9 ! environm5t & 9 human bodies & are f\nd across ! _w1 includ+ 9 ! remote ,arctic 9 :i* ,native ,am]icans face increas+ contam9ation ( traditional foods2 7#g7 diff]5ces 9 metabolism & physiology at c]ta9 /ages ( developm5t c make infants & *ildr5 m vuln]able ?an adults to ! effects ( *emical exposure1 especially exposure t occurs 9 ut]o1 dur+ infancy1 & dur+ o!r critical p]iods ( developm5t2 7#h7 manufactur]s & processors ( *emicals %\ld supply suffici5t heal? & environm5tal in=mation be=e di/ribut+ products 9 comm]ce2 7#i7 ! ,adm9i/rator mu/ h & ex]cise ! au?ority to develop suffici5t in=mation to assess *emical safety1 & to act effectively :5 ! ,adm9i/rator obta9s in=mation t indicates !re are risks ( h>mful exposure to *emical sub/ances2 7#aj7 !re is significant global trade 9 ! *emical sector & _m ( ! companies t conduct bus9ess 9 ! ,unit$ ,/ates mu/ also comply ) *emical safety regulatory programs 9 o!r c\ntries1 & ! data t is g5]at$ to comply ) ^? o!r regulatory programs may be useful 9 und]/&+ haz>ds & exposures ( *emical sub/ances pres5t$ 9 ! ,unit$ ,/ates2 & 7#aa7 a revis$ policy on ! safety ( *emical sub/ances w assi/ 9 r5ew+ ! manufactur+ sector ( ! ,unit$ ,/ates1 create new & saf] jobs1 spur innovations 9 gre5 *emi/ry1 re/ore confid5ce dome/ically & int]nationally 9 ! safety ( products ( ! ,unit$ ,/ates1 & ensure t products ( ! ,unit$ ,/ates rema9 competitive 9 ! global m>ket4 7b7 ,policy ,x is ! policy ( ! ,unit$ ,/ates-- 7#a7 to protect ! heal? ( *ildr51 work]s1 consum]s1 & ! public1 & to protect ! environm5t f h>mful exposures to *emical sub/ances2 7#b7 to promote ! use ( saf] alt]natives & o!r actions t r$uce ! use ( & exposure to haz>d\s *emical sub/ances & rew>d innovation t[>d saf] *emicals1 processes1 & products2 7#c7 to require t *emicals 9 comm]ce meet a risk-bas$ safety /&>d t protects vuln]able & affect$ populations & ! environm5t2 7#d7 to require companies to provide suffici5t heal? & environm5tal in=mation = ! *emical sub/ances t ! companies manufacture1 process1 or import z a condition ( all[+ ^? companies to di/ribute *emical sub/ances 9 comm]ce2 7#e7 to improve ! quality ( in=mation on *emical safety & use2 7#f7 to gu>antee ! "r ( ! public & work]s to "k ab\t ! haz>ds & uses ( *emical sub/ances t ! public & work]s may be expos$ to by maximiz+ public access to in=mation on *emical safety & use2 & 7#g7 to /r5g!n coop]ation betwe5 & among ! ,f$]al ,gov]nm5t & ,/ate1 municipal1 tribal1 & =eign gov]nm5ts4 7c7 ,goal ,x is ! goal ( ! ,unit$ ,/ates to address ! h>mful exposure ( vuln]able or affect$ populations to *emical sub/ances caus$ by ! di/ribution ( *emical sub/ances 9 comm]ce by-- 7#a7 review+ all *emical sub/ances = safety & id5tify+ ! highe/ priority *emical sub/ances = exp$it$ review2 7#b7 det]m9+ :e!r *emical sub/ances 9 comm]ce meet ! safety /&>d "u ?is title2 7#c7 apply+ appropriate re/rictions to ! use ( a *emical sub/ance1 :]e w>rant$2 & 7#d7 enc\rag+ ! replacem5t ( h>mful *emicals & processes ) saf] alt]natives4 4 #d4 ,def9itions ,section #c ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjb7 is am5d$-- 7#a7 by /rik+ p>agraph 7#ab72 7#b7 by r$esignat+ p>agraphs 7#b71 7#c71 7#d71 7#e71 7#f71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ac71 & 7#ad71 z p>agraphs 7#e71 7#f71 7#h71 7#aj71 7#ab71 7#ac71 7#ad71 7#ae71 7#ah71 7#ai71 7#ba71 & 7#bd71 respectively2 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,aggregate exposure 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! t]m aggregate exposure means exposure f all s\rces ( a *emical sub/ance1 includ+ exposure f-- 7i7 ! manufacture1 process+1 di/ribution1 use1 & disposal ( t *emical sub/ance2 & 7ii7 all o!r s\rces ( t *emical sub/ance1 includ+-- 7,i7 contam9ation ( food1 air1 wat]1 soil1 & h\se du/ f curr5t or prior uses or activity2 7,,ii7 accid5tal releases2 7,,iii7 p]mitt$ s\rces ( pollution2 7,,iv7 nonpo9t s\rces ( pollution2 7,v7 docum5t$ backgr\nd levels f natural & an?ropog5ic s\rces2 & 7,,vi7 a mixture or article conta9+ t *emical sub/ance4 7,b7 ,inclusions ,! t]m aggregate exposure includes exposure f a *emical sub/ance t is n consid]$ to be a *emical sub/ance "u ?is ,act solely because ( ! use ( t sub/ance z1 or 91 a food1 food additive1 cosmetic1 or device 7z ^? t]ms are def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba774 7#c7 ,bioaccumulative 7,a7 ,9 g5]al ,! t]m bioaccumulative means1 ) respect to a *emical sub/ance or mixture1 t ! *emical sub/ance or mixture1 z det]m9$ by ! ,adm9i/rator1 c significantly accumulate 9 biota1 z indicat$ ?r\gh monitor+ data1 or is highly likely to accumulate 9 biota1 z indicat$ by o!r evid5ce4 7,b7 ,update ,to reflect ! be/ available sci5ce1 ! ,adm9i/rator may1 by rule1 revise ! def9ition ( ! t]m bioaccumulative 9 su* a way t reflects ! /ate ( ! sci5ce & provides = equal or great] protection ( human heal? & ! environm5t4 7#d7 ,*emical id5tity ,! t]m *emical id5tity includes-- 7,a7 ea* common & trade "n ( a *emical sub/ance2 7,b7 ! "n ( a *emical sub/ance appe>+ 9 ,int]national ,union ( ,pure & ,appli$ ,*emi/ry nom5clature & ! mo/ curr5t ,collective ,index =mat2 7,c7 ea* ,*emical ,ab/racts ,s]vice regi/ration numb] ( a *emical sub/ance2 & 7,d7 ! molecul> /ructure ( a *emical sub/ance4 2 7#d7 9 p>agraph 7#e7 7z r$esignat$ by p>agraph 7#b77-- 7,a7 by /rik+ 7#b77;,a7 ,except z provid$ 9 subp>agraph 7,b7 & ins]t+ ! foll[+3 7#e7 ,*emical sub/ance 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraphs 7,b7 & 7,c7 2 7,b7 9 subp>agraph 7,b71 by /rik+ 7,b7 ,su* t]m & ins]t+ ! foll[+3 7,b7 ,exclusions ,! t]m *emical sub/ance 2 & 7,c7 by add+ at ! end ! foll[+3 7,c7 ,inclusions ,not)/&+ molecul> id5tity1 ! ,adm9i/rator may det]m9e t a v>iant ( a *emical sub/ance is a new *emical sub/ance "u section #e7;a77#f74 2 7#e7 by ins]t+ aft] p>agraph 7#f7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7#g7 ,cumulative exposure ,! t]m cumulative exposure means ! sum ( aggregate exposure to ea* ( ! *emical sub/ances t are kn[n or suspect$ to contribute appreciably to ! risk ( ! same or a simil> adv]se effect4 2 7#f7 by /rik+ p>agraph 7#h7 7z r$esignat$ by p>agraph 7#b77 & ins]t+ ! foll[+3 7#h7 ,di/ribute 9 comm]ce ,! t]ms di/ribute 9 comm]ce & di/ribution 9 comm]ce1 :5 us$ to describe an action tak5 ) respect to a *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance71 mean-- 7,a7 to sell1 or ! sale (1 ! sub/ance1 mixture1 or article 9 comm]ce2 7,b7 to introduce or deliv] = introduction into comm]ce1 or ! introduction or deliv]y = introduction into comm]ce (1 ! sub/ance1 mixture1 or article2 7,c7 to hold1 or ! hold+ (1 ! sub/ance1 mixture1 or article aft] its introduction into comm]ce2 or 7,d7 to export or (f] = export ! sub/ance1 mixture1 or article4 2 7#g7 by ins]t+ aft] p>agraph 7#h7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7#i7 ,end consum] ,! t]m end consum] means an individual or o!r entity t pur*ases & uses or consumes a *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance74 2 7#h7 9 p>agraph 7#aj7 7z r$esignat$ by p>agraph 7#b771 by ins]t+ ambi5t & indoor aft] includes wat]12 7#i7 by ins]t+ aft] p>agraph 7#aj7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7#aa7 ,f$]al ag5cy ,! t]m ,f$]al ag5cy means any dep>tm5t1 ag5cy1 or o!r in/rum5tality ( ! ,f$]al ,gov]nm5t1 any indep5d5t ag5cy or e/abli%m5t ( ! ,f$]al ,gov]nm5t includ+ any ,gov]nm5t corporation1 & ! ,gov]nm5t ,pr9t+ ,(fice4 2 7#aj7 9 p>agraph 7#ae7 7z r$esignat$ by p>agraph 7#b771 by /rik+ :i* is n includ$ 9 ! *emical sub/ance li/ compil$ & publi%$ "u section #h7;b7 & ins]t+ = :i* ! manufactur] or processor ( ! *emical sub/ance has n submitt$ a decl>ation "u section #h7;a72 7#aa7 by ins]t+ aft] p>agraph 7#ae7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7#af7 ,p]si/5t 7,a7 ,9 g5]al ,! t]m p]si/5t means1 ) respect to a *emical sub/ance or mixture1 t ! *emical sub/ance or mixture1 z det]m9$ by ! ,adm9i/rator1 significantly p]si/s 9 #a or m environm5tal m$ia1 z indicat$ by monitor+ data or o!r evid5ce4 7,b7 ,update ,to reflect ! be/ available sci5ce1 ! ,adm9i/rator may1 by rule1 revise ! def9ition ( ! t]m p]si/5t 9 su* a way t reflects ! /ate ( ! sci5ce & provides = equal or great] protection ( human heal? & ! environm5t4 7#ag7 ,p]son 7,a7 ,9 g5]al ,! t]m p]son means an individual1 tru/1 firm1 jo9t /ock company1 corporation 7includ+ a ,gov]nm5t corporation71 p>tn]%ip1 association1 ,/ate1 municipality1 commission1 political subdivision ( a ,/ate1 or any int]/ate body4 7,b7 ,inclusions ,! t]m p]son includes ea* ,f$]al ag5cy & any (fic]1 ag5t1 or employee ( a ,f$]al ag5cy4 2 7#ab7 by ins]t+ aft] p>agraph 7#ai7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7#bj7 ,special sub/ance *>act]i/ic 7,a7 ,9 g5]al ,! t]m special sub/ance *>act]i/ic means a physical1 *emical1 or biological *>act]i/ic1 o!r ?an molecul> id5tity1 t ! ,adm9i/rator det]m9es1 by ord] or rule1 may significantly affect ! risks pos$ by sub/ances exhibit+ t *>act]i/ic4 7,b7 ,consid]ations ,9 det]m9+ ! exi/5ce ( special sub/ance *>act]i/ics1 ! ,adm9i/rator may consid]-- 7i7 size or size di/ribution2 7ii7 %ape & surface /ructure2 7iii7 reactivity2 & 7iv7 any o!r prop]ties t may significantly affect ! risks pos$4 2 7#ac7 by ins]t+ aft] p>agraph 7#ba7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7#bb7 ,toxic ,! t]m toxic1 ) respect to a *emical sub/ance or mixture1 means t ! *emical sub/ance or mixture has a toxicological prop]ty-- 7,a7 meet+ ! crit]ia = ,category #a or ,category #b = any ( ! toxicity endpo9ts e/abli%$ by ! ,globally ,h>moniz$ ,sy/em = ! ,classification & ,label+ ( ,haz>d\s ,sub/ances2 7,b7 t causes an adv]se effect t has be5 demon/rat$ 9 humans or o!r expos$ organisms2 or 7,c7 = :i* ! weight ( evid5ce 7su* z demon/ration ( an adv]se effect describ$ 9 subp>agraph 7,b71 laboratory /udies1 or data = a *emical f ! same *emical class t exhibits t adv]se effect7 demon/rates ! pot5tial = an adv]se effect 9 humans or o!r expos$ organisms4 7#bc7 ,toxicological prop]ty ,! t]m toxicological prop]ty means actual or pot5tial toxicity or o!r adv]se effects ( a *emical sub/ance or mixture1 includ+ actual or pot5tial effects ( exposure to a *emical sub/ance or mixture on-- 7,a7 mortality2 7,b7 morbidity1 includ+ c>c9og5esis2 7,c7 reproduction2 7,d7 gr[? & developm5t2 7,e7 ! immune sy/em2 7,f7 ! endocr9e sy/em2 7,g7 ! bra9 or n]v\s sy/em2 7,h7 o!r organ sy/ems2 or 7,i7 any o!r biological functions 9 humans or nonhuman organisms4 2 & 7#ad7 by add+ at ! end ! foll[+3 7#be7 ,vuln]able human population ,! t]m vuln]able human population means a human population t is subject to disproportionate exposure to1 or ! pot5tial = disproportionate adv]se effect f exposure to1 a *emical sub/ance or mixture1 includ+-- 7,a7 infants1 *ildr51 & adolesc5ts2 7,b7 pregnant wom52 7,c7 eld]ly2 7,d7 individuals ) preexi/+ m$ical conditions2 7,e7 work]s t "w ) *emical sub/ances & mixtures2 & 7,f7 memb]s ( any o!r appropriate population id5tifi$ by ! ,adm9i/rator4 4 #e4 ,m9imum in=mation sets & te/+ ( *emical sub/ances ,section #d ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjc7 is am5d$ to read z foll[s3 #d4 ,m9imum in=mation sets & te/+ ( *emical sub/ances 7a7 ,m9imum in=mation sets 7#a7 ,rule 7,a7 ,9 g5]al ,subject to subp>agraphs 7,b7 & 7,c71 & n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all e/abli%1 by rule1 su* m9imum in=mation sets z ! ,adm9i/rator det]m9es to be appropriate to evaluate *emical sub/ances "u sections #e & #f4 7,b7 ,g5]al requirem5ts ,! rule promulgat$ pursuant to subp>agraph 7,a7 %all-- 7i7 provide = v>i$ or ti]$ in=mation to be provid$ = diff]5t *emical sub/ances2 7ii7 id5tify ! p>ticul> m9imum in=mation set t applies to a *emical sub/ance2 7iii7 require ea* m9imum in=mation set to include suffici5t in=mation = ! ,adm9i/rator to conduct a scre5+-level risk assessm5t ( ! *emical sub/ance1 includ+ in=mation on ! *>act]i/ics1 toxicological prop]ties1 environm5tal & biological fate & behavior1 exposure1 & use ( a *emical sub/ance2 7iv7 specify in=mation quality & reliability requirem5ts applicable to ! in=mation submitt$ 9 ! m9imum in=mation sets2 & 7v7 accommodate ! use ( alt]native te/+ me?ods & te/+ /rategies to g5]ate in=mation quickly1 at l[ co/1 & ) r$uc$ use ( animal-bas$ te/+1 includ+ toxicity pa?way-bas$ risk assessm5t1 9 vitro /udies1 sy/ems biology1 computational toxicology1 bio9=matics1 & high-?r\ghput scre5+1 to ! ext5t su* me?ods & /rategies w\ld yield in=mation ( equival5t quality & reliability4 7,c7 ,specific requirem5ts ,! rule promulgat$ pursuant to subp>agraph 7,a7 %all e/abli% m9imum in=mation sets suffici5t = ! ,adm9i/rator to adm9i/] ?is ,act1 includ+ to c>ry out-- 7i7 categorization ( new *emical sub/ances "u section #e7;b77#b71 includ+ ! id5tification ( in=mation-- 7,i7 suffici5tly robu/ to g5]ally support ! categorization ( a new *emical sub/ance z a sub/ance ( v l[ conc]n "u section #e7;b77#b77;,d77iii77,,ii72 & 7,,ii7 9 ! abs5ce ( :i* ! ,adm9i/rator %all designate a new *emical sub/ance to be a sub/ance ) insuffici5t in=mation "u section #e7;b77#b77;,d77iv72 7ii7 categorization ( exi/+ *emical sub/ances "u section #f7;b77#c71 includ+ ! id5tification ( in=mation-- 7,i7 suffici5tly robu/ to g5]ally support ! categorization ( an exi/+ *emical sub/ance z a sub/ance ( v l[ conc]n "u section #f7;b77#c77;,b77ii72 & 7,,ii7 9 ! abs5ce ( :i* ! ,adm9i/rator %all designate an exi/+ *emical sub/ance to be a sub/ance ) insuffici5t in=mation "u section #f7;b77#c77;,b77iv72 7iii7 assignm5t ( *emical sub/ances to priority classes "u section #f7;b77#d72 7iv7 safety /&>d det]m9ations-- 7,i7 = new uses ( exi/+ *emical sub/ances "u section #e7;b77#b72 & 7,,ii7 = *emical sub/ances "u section #f7;d72 & 7v7 safety /&>d r$et]m9ations "u section #f7;d77#e77;,e74 7#b7 ,submission ( m9imum in=mation set ,ea* manufactur] & processor ( a *emical sub/ance %all submit ! m9imum in=mation set = ! *emical sub/ance to ! ,adm9i/rator-- 7,a7 = new *emical sub/ances1 concurr5t ) ! notice requir$ "u section 7#e77;b77#a77;,a72 & 7,b7 = exi/+ *emical sub/ances1 z specifi$ 9 section #f or o!rwise specifi$ by ! ,adm9i/rator 9 ! rule promulgat$ pursuant to p>agraph 7#a77;,a74 7#c7 ,prohibition ,9 addition to any o!r au?orities available "u ?is ,act1 ! ,adm9i/rator may1 by ord]1 take any action au?oriz$ "u section #f7;f7 if a manufactur] or processor is 9 violation ( p>agraph 7#b74 7b7 ,te/+ 7#a7 ,g5]al submissions 7,a7 ,9 g5]al ,! ,adm9i/rator may1 by rule or ord]1 require te/+ ) respect to any *emical sub/ance1 & ! submission ( te/ results by a specifi$ date1 z appropriate = mak+ any det]m9ation or c>ry+ out any provision ( ?is ,act4 ,su* te/+ may be requir$-- 7i7 to provide in=mation 9 addition to ! in=mation specifi$ 9 any applicable m9imum in=mation set "u subsection 7a72 & 7ii7 ( p]sons to :om ! ,adm9i/rator decides n to apply a requirem5t to submit a m9imum in=mation set "u subsection 7a74 7,b7 ,effect on o!r au?ority ,no?+ 9 ?is p>agraph limits ! au?ority ( ! ,adm9i/rator "u p>agraph 7#b74 7#b7 ,sample submissions 7,a7 ,9 g5]al ,! ,adm9i/rator may1 by rule or ord]1 require ! submission ( a sample ( any *emical sub/ance 9 su* mann] z ! ,adm9i/rator det]m9es enables ! ,adm9i/rator to conduct any te/s necess>y = mak+ any det]m9ation or c>ry+ out any provision ( ?is ,act4 7,b7 ,effect on o!r au?ority ,no?+ 9 ?is p>agraph limits ! au?ority ( ! ,adm9i/rator "u p>agraph 7#a74 7#c7 ,prohibition ,9 addition to any o!r au?orities available "u ?is ,act1 ! ,adm9i/rator may1 by ord]1 take any action au?oriz$ "u section #f7;f7 if a manufactur] or processor is 9 violation ( a rule or ord] "u p>agraph 7#a74 7#d7 ,exemption ,if a manufactur] or processor ceases all manufacture or process+ ( a *emical sub/ance pursuant to its submission ( a decl>ation ( cessation ( manufacture or process+ "u section #h7;b77#d7 = ! *emical sub/ance1 ! manufactur] or processor %all be exempt$ f ! requirem5ts ( ?is subsection4 7c7 ,te/ rules or ord]s 7#a7 ,9 g5]al ,a rule or ord] issu$ "u subsection 7b7 %all include-- 7,a7 id5tification ( ! *emical sub/ance = :i* te/+ is requir$ "u ! rule or ord]2 7,b7 /&>ds = ! developm5t ( te/ in=mation = t sub/ance2 & 7,c7 a specification ( ! p]iod 7:i* may n be ( unreasonable duration7 )9 :i* ! p]sons requir$ to conduct ! te/+ %all submit to ! ,adm9i/rator in=mation develop$ 9 accordance ) ! /&>ds ref]r$ to 9 subp>agraph 7,b74 7#b7 ,consid]ations 7,a7 ,9 g5]al ,9 det]m9+ ! /&>ds & p]iod to be requir$ "u subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#a71 ! ,adm9i/rator %all consid]-- 7i7 ! relative co/s ( ! v>i\s te/ protocols & me?odologies t may be requir$ "u ! rule or ord]2 & 7ii7 ! reasonably =eseeable availability ( ! facilities & p]sonnel ne$$ to p]=m ! te/+ requir$ "u ! rule4 7,b7 ,prelim9>y in=mation ,any rule or ord] issu$ by ! ,adm9i/rator "u ?is subsection may require a manufactur] or processor to submit prelim9>y in=mation dur+ ! p]iod describ$ 9 p>agraph 7#a77;,c74 7#c7 ,types ( heal? & environm5tal in=mation 7,a7 ,9 g5]al ,! ,adm9i/rator may prescribe /&>ds = ! developm5t ( te/ in=mation "u ?is subsection = heal? & environm5tal in=mation1 includ+-- 7i7 in=mation p]ta9+ to c>c9og5esis1 mutag5esis1 t]atog5esis1 behavioral disord]s1 or cumulative1 syn]gi/ic1 or any o!r effect t may be consid]$ 9 a safety /&>d det]m9ation2 7ii7 in=mation p]ta9+ to exposure to ! *emical sub/ance1 includ+ in=mation reg>d+ ! pres5ce ( ! *emical sub/ance 9 human blood1 fluids1 or tissue2 & 7iii7 in=mation p]ta9+ to-- 7,i7 bioaccumulation2 7,,ii7 p]si/5ce2 7,,iii7 acute toxicity2 7,,iv7 subacute toxicity2 7,v7 *ronic toxicity2 & 7,,vi7 any o!r *>act]i/ic t may pres5t an adv]se effect4 7,b7 ,me?odologies 7i7 ,9 g5]al ,! ,adm9i/rator may prescribe me?odologies 9 /&>ds = ! developm5t ( te/ in=mation1 includ+-- 7,i7 epidemiologic /udies2 7,,ii7 biomonitor+ or environm5tal monitor+ /udies2 7,,iii7 s]ial or hi]>*ical te/s2 7,,iv7 9 vitro te/s2 7,v7 :ole animal te/s1 consi/5t ) section #cj2 & 7,,vi7 any o!r me?odology deem$ appropriate by ! ,adm9i/rator4 7ii7 ,requirem5t ,prior to prescrib+ epidemiologic /udies ( employees1 ! ,adm9i/rator %all consult ) ! ,director ( ! ,national ,in/itute = ,occupational ,safety & ,heal?4 7,c7 ,review ,p]iodically1 b n less frequ5tly ?an once e #c ye>s1 ! ,adm9i/rator %all-- 7i7 review ! adequacy ( ! /&>ds = developm5t ( in=mation prescrib$ "u subp>agraph 7,a72 & 7ii7 if necess>y1 in/itute proce$+s to make appropriate revisions ( ^? /&>ds4 7#d7 ,p]sons requir$ to conduct te/s & submit in=mation 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 a rule or ord] "u subsection 7b7 respect+ a *emical sub/ance %all specify ! p]sons requir$ to conduct te/s & submit in=mation to ! ,adm9i/rator on ! sub/ance4 7,b7 ,exception ,! ,adm9i/rator may p]mit #b or m ( ! p]sons describ$ 9 subp>agraph 7,a7 to designate #a ( ! p]sons or a qualifi$ ?ird p>ty to conduct ! te/s & submit ! in=mation on behalf ( ! p]sons mak+ ! designation4 7,c7 ,liability ,all p]sons describ$ 9 subp>agraphs 7,a7 & 7,b7 %all rema9 liable = compliance ) any requirem5ts subject to ! designation4 7#e7 ,expiration ( rules & ord]s 7,a7 ,9 g5]al ,any rule or ord] "u subsection 7b7 t requires ! te/+ & submission ( in=mation = a p>ticul> *emical sub/ance %all expire at ! end ( ! applicable reimbursem5t p]iod 7z def9$ 9 subsection 7d77#c77 unless1 prior to t date1 ! ,adm9i/rator )draws ! rule or ord]4 7,b7 ,category ( *emical sub/ances ,a rule or ord] "u subsection 7b7 t requires ! te/+ & submission ( in=mation = a category ( *emical sub/ances %all expire ) respect to a *emical sub/ance includ$ 9 ! category at ! end ( ! applicable reimbursem5t p]iod 7z def9$ 9 subsection 7d77#c77 unless1 prior to t date1 ! ,adm9i/rator )draws ! rule or ord] ) respect to ! sub/ance entirely4 7d7 ,exemptions 7#a7 ,9 g5]al ,any p]son requir$ by a rule or ord] "u subsections 7a7 or 7b7 to conduct te/s & submit in=mation = a *emical sub/ance may apply to ! ,adm9i/rator 79 su* =m & mann] z ! ,adm9i/rator det]m9es necess>y7 = an exemption f ! requirem5t4 7#b7 ,action by ,adm9i/rator ,9 accordance ) p>agraph 7#c7 or 7#d71 ! ,adm9i/rator %all exempt an applicant "u p>agraph 7#a71 if1 on receipt ( ! application1 ! ,adm9i/rator det]m9es t-- 7,a7 ! *emical sub/ance = :i* ! application 0 submitt$ is equival5t to a *emical sub/ance = :i*-- 7i7 in=mation has be5 submitt$ to ! ,adm9i/rator 9 accordance ) a rule or ord] "u subsection 7a7 or 7b72 or 7ii7 in=mation is be+ develop$ 9 accordance ) ! rule or ord]2 & 7,b7 submission ( in=mation by ! applicant = ! sub/ance w\ld be duplicative ( in=mation t-- 7i7 has be5 submitt$ to ! ,adm9i/rator 9 accordance ) ! rule or ord] "u subsection 7a7 or 7b72 or 7ii7 is be+ develop$ 9 accordance ) ! rule or ord]4 7#c7 ,reimbursem5t due to exemption 7,a7 ,def9ition ( reimbursem5t p]iod ,9 ?is p>agraph1 ! t]m reimbursem5t p]iod1 ) respect to any te/ in=mation = a *emical sub/ance1 means a p]iod t-- 7i7 beg9s on ! date on :i* ! te/ in=mation is submitt$ 9 accordance ) a rule or ord] issu$ "u subsection 7a7 or 7b72 & 7ii7 ends on ! lat] (-- 7,i7 #e ye>s aft] ! date ref]r$ to 9 clause 7i72 & 7,,ii7 ! date :i*1 z det]m9$ by ! ,adm9i/rator1 provides ! applicant ) a "t p]iod :i* is suffici5t to develop ! te/ in=mation4 7,b7 ,reimbursem5t = previ\sly submitt$ te/ in=mation 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 = an exemption "u p>agraph 7#b77;,b77i71 if ! exemption is grant$ dur+ ! reimbursem5t p]iod = ! te/ in=mation1 ! ,adm9i/rator %all ord] ! p]son grant$ ! exemption to provide fair & equitable reimbursem5t 79 an am\nt det]m9$ by ! ,adm9i/rator7 to-- 7,i7 ! p]son :o previ\sly submitt$ ! te/ in=mation1 = a portion ( ! co/s incurr$ by ! p]son 9 comply+ ) ! in=mation submission requirem5t2 & 7,,ii7 any o!r p]son :o has be5 requir$ "u ?is subsection to contribute ) respect to ! co/s1 = a portion ( ! am\nt ! p]son 0 requir$ to contribute4 7ii7 ,exception ,clause 7i7 %all n apply if !re is agreem5t on ! am\nt & me?od ( reimbursem5t betwe5 an exempt$ p]son describ$ 9 clause 7i7 & ! p]sons describ$ 9 subclauses 7,i7 & 7,,ii7 ( t clause4 7iii7 ,consid]ations ,9 promulgat+ rules = ! det]m9ation ( fair & equitable reimbursem5t to ! p]sons describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7i7 = co/s incurr$ ) respect to a *emical sub/ance1 ! ,adm9i/rator %all1 aft] consultation ) ! ,attorney ,g5]al & ! ,f$]al ,trade ,commission1 consid] all relevant factors1 includ+-- 7,i7 ! effect on ! competitive position ( ! p]son requir$ to provide reimbursem5t 9 relation to ! p]son to be reimburs$2 & 7,,ii7 ! %>e ( ! m>ket = ! sub/ance ( ! p]son requir$ to provide reimbursem5t 9 relation to ! %>e ( ! m>ket ( ! p]sons to be reimburs$4 7,c7 ,reimbursem5t due to exemption = te/ in=mation be+ develop$ 9 accordance ) rule or ord] 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 = an exemption "u p>agraph 7#b77;,b77ii71 ! ,adm9i/rator %all ord] ! p]son grant$ ! exemption to provide fair & equitable reimbursem5t 79 an am\nt det]m9$ by ! ,adm9i/rator7 to-- 7,i7 ea* p]son :o is develop+ ! te/ in=mation1 = ! portion ( ! co/s incurr$ by ea* p]son 9 comply+ ) ! rule or ord]2 & 7,,ii7 any o!r p]son :o has be5 requir$ "u ?is subsection to contribute ) respect to ! co/s ( comply+ ) ! rule or ord]1 = a portion ( ! am\nt ! p]son 0 requir$ to contribute4 7ii7 ,exception ,clause 7i7 %all n apply if !re is agreem5t on ! am\nt & me?od ( reimbursem5t betwe5 an exempt$ p]son describ$ 9 clause 7i7 & ! p]sons describ$ 9 subclauses 7,i7 & 7,,ii7 ( t clause4 7iii7 ,consid]ations ,9 promulgat+ rules = ! det]m9ation ( fair & equitable reimbursem5t to ! p]sons describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7i7 = co/s incurr$ ) respect to a *emical sub/ance1 ! ,adm9i/rator %all1 aft] consultation ) ! ,attorney ,g5]al & ! ,f$]al ,trade ,commission1 consid] ! factors describ$ 9 subp>agraph 7,b77iii74 7iv7 ,lack ( compliance ,if any exemption is grant$ "u p>agraph 7#b7 on ! basis t #a or m p]sons are develop+ te/ in=mation pursuant to a rule or ord] promulgat$ or issu$ "u subsection 7a7 or 7b71 & aft] ! exemption is grant$1 ! ,adm9i/rator det]m9es t no p]son has compli$ ) ! rule or ord]1 ! ,adm9i/rator %all-- 7,i7 aft] provid+ writt5 notice & an opportunity = a he>+ to ! p]son :o holds ! exemption1 by ord]1 t]m9ate ! exemption2 & 7,,ii7 notify 9 writ+ ! p]son ( ! requirem5ts ( ! rule or ord] ) respect to :i* ! exemption 0 grant$4 7e7 ,notice 7#a7 ,9 g5]al ,n lat] ?an #ae days aft] ! date ( receipt ( any te/ in=mation pursuant to a rule or ord] "u subsection 7a7 or 7b71 ! ,adm9i/rator %all publi% 9 ! ,f$]al ,regi/] a notice ( ! receipt ( ! te/ in=mation4 7#b7 ,requirem5ts ,subject to section #ad1 ea* notice %all-- 7,a7 id5tify ! *emical sub/ance = :i* in=mation has be5 receiv$2 7,b7 li/-- 7i7 ! comm]cial & consum] uses or int5d$ comm]cial & consum] uses ( ! sub/ance kn[n to ! ,adm9i/rator2 & 7ii7 ! in=mation requir$ by ! applicable /&>ds = ! developm5t ( te/ in=mation2 & 7,c7 describe ! nature ( ! te/ in=mation develop$4 7#c7 ,availability ,subject to section #ad1 ! ,adm9i/rator %all make ! te/ in=mation describ$ 9 ?is subsection available on a publicly accessible ,int]net site4 7f7 ,reque/s f o!r ag5cies = additional in=mation or te/+ 7#a7 ,9 g5]al ,! head ( a ,f$]al ag5cy may reque/ ! ,adm9i/rator to seek ! in=mation on behalf ( t ag5cy if ! head ( t ,f$]al ag5cy det]m9es t-- 7,a7 in=mation relat+ to a *emical sub/ance1 includ+ in=mation d]iv$ f new te/+ or monitor+1 w\ld assi/ t ,f$]al ag5cy 9 c>ry+ out ! duties or ex]cis+ ! au?ority ( t ag5cy2 b 7,b7 ! reque/$ in=mation is n available to t ag5cy4 7#b7 ,duty ( ,adm9i/rator ,n lat] ?an #fj days aft] ! date ( receipt ( a reque/ "u p>agraph 7#a71 ! ,adm9i/rator %all-- 7,a7 subject to section #ad1 make ! in=mation available to ! reque/+ ag5cy or in/itution2 7,b7 issue a reque/ "u section #h7k7 to require-- 7i7 ! submission ( exi/+ p]t95t in=mation to ! ,adm9i/rator2 & 7ii7 a copy ( any su* submission to be furni%$ to ! reque/+ ag5cy or in/itution2 7,c7 issue a rule or ord] "u subsection 7b7-- 7i7 to develop ! in=mation2 & 7ii7 to require ! develop$ in=mation to be furni%$ to ! reque/+ ag5cy or in/itution2 or 7,d7 publi% 9 ! ,f$]al ,regi/] ! reason = :i* none ( ! actions describ$ 9 ?is p>agraph 7 tak54 7g7 ,c]tification ,ea* p]son :o submits in=mation "u ?is section or "u a rule or an ord] promulgat$ or issu$ by ! ,adm9i/rator "u ?is section %all accompany ! in=mation ) a c]tification sign$ by a responsible (ficial t ea* /atem5t conta9$ 9 ! submission-- 7#a7 is accurate & reliable2 & 7#b7 includes all mat]ial facts kn[n to1 9 ! possession or control (1 or reasonably asc]ta9able by1 ! p]son4 4 #f4 ,new *emical sub/ances & new uses ( *emical sub/ances ,section #e ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjd7 is am5d$ to read z foll[s3 #e4 ,new *emical sub/ances & new uses ( *emical sub/ances 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufacture & process ,! t]ms manufacture & process mean manufacture or process1 respectively1 = comm]cial purposes4 7#b7 ,te/ m>ket+ ,! t]m te/ m>ket+ does n include any provision ( a *emical sub/ance or mixture1 or an article conta9+ a *emical sub/ance or mixture1 to an end consum] ( ! *emical sub/ance1 mixture1 or article4 7b7 ,new *emical sub/ances 7#a7 ,notices ,except z provid$ 9 subsection 7h71 no p]son may manufacture a new *emical sub/ance1 or process ! *emical sub/ance = a use t is propos$ to meet ! crit]ia describ$ 9 section #f7;h77#b77;,b71 unless-- 7,a7 ! p]son submits to ! ,adm9i/rator a notice1 9 accordance ) subsection 7g77#a77;,a71 ( ! int5tion ( ! p]son to manufacture or process ! sub/ance2 7,b7 ! p]son complies ) subsection 7f72 & 7,c7 ! ,adm9i/rator f9ds t-- 7i7 ! new *emical sub/ance is likely to meet ! safety /&>d "u section #f7;d71 :i* %all be limit$ to sub/ances assign$ by ! ,adm9i/rator to #a ( ! categories describ$ 9 p>agraph 7#b77;,d77iii72 or 7ii7 ! p]son has e/abli%$ by cle> & conv9c+ evid5ce t #a or m uses ( ! new *emical sub/ance meet ! crit]ia describ$ 9 section #f7;h77#b77;,b71 9 :i* case-- 7,i7 ! ,adm9i/rator may by ord] all[ ! p]son to manufacture or process ! sub/ance only = su* use or uses 9 accordance ) subp>agraph 7,a7 ( section #f7;h77#b72 7,,ii7 ! proc$ures & requirem5ts specifi$ 9 subp>agraphs 7,a71 7,c71 7,d71 & 7,e7 ( section #f7;h77#b7 %all apply2 & 7,,iii7 ! ,adm9i/rator %all n1 ^u receipt ( a notice ( comm5cem5t = ! *emical sub/ance "u subsection 7d71 add ! *emical sub/ance to ! active inv5tory e/abli%$ "u section #h7;h77#a74 7#b7 ,categorization ( new *emical sub/ances 7,a7 ,rule ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all promulgate a rule t-- 7i7 designates ! categories 9 accordance ) subp>agraph 7,d7 & specifies ! process & crit]ia ! ,adm9i/rator w use to categorize new *emical sub/ances2 & 7ii7 describes crit]ia & factors ! ,adm9i/rator w use to assess weight ( evid5ce & ! quality & reliability ( in=mation us$ to in=m categorization decisions4 7,b7 ,in=mation s\rces ,9 categoriz+ a new *emical sub/ance1 ! ,adm9i/rator %all consid] in=mation on ! sub/ance available to ! ,adm9i/rator at ! "t ! categorization decision is to be made1 includ+ in=mation-- 7i7 receiv$ by ! ,adm9i/rator f ! manufactur] or processor ( ! sub/ance 9 accordance ) subsection 7f72 7ii7 submitt$ to a gov]nm5tal body 9 ano!r jurisdiction1 to ! ext5t t ! in=mation is accessible to ! ,adm9i/rator2 7iii7 d]iv$ ?r\gh application ( validat$ /ructure-activity relation%ip or o!r models develop$ by ! ,adm9i/rator to e/imate ! environm5tal & human heal? effects1 environm5tal & biological fate & behavior1 & exposure pot5tial ( *emical sub/ances2 7iv7 inf]r$ bas$ on ! degree ( simil>ity ( ! /ructure or prop]ties ( ! new *emical sub/ance to ^? ( #a or m o!r *emical sub/ances = :i* reliable in=mation exi/s t is relevant to pr$ict+ ! pot5tial environm5tal or human heal? effects1 environm5tal or biological fate & behavior1 or exposure pot5tial ( ! new *emical sub/ance2 & 7v7 any additional in=mation ! ,adm9i/rator det]m9es is ne$$ to categorize ! sub/ance1 includ+ in=mation id5tifi$ z ne$$ bas$ on ! analysis by ! ,adm9i/rator ( e/imat$ or inf]r$ in=mation describ$ 9 clauses 7iii7 & 7iv74 7,c7 ,tim+ ,n lat] ?an #ij days aft] ! date ( receipt ( a notice "u p>agraph 7#a77;,a71 ! ,adm9i/rator %all assign ! new *emical sub/ance = :i* ! notice 0 submitt$ to #a ( ! categories describ$ 9 subp>agraph 7,d74 7,d7 ,categories 7i7 ,9 g5]al ,! rule promulgat$ pursuant to subp>agraph 7,a7 %all incorporate1 e/abli% crit]ia =1 & fur!r specify z ne$$1 ! categories describ$ 9 ?is subp>agraph1 to #a ( :i* ea* new *emical sub/ance = :i* a notice is submitt$ pursuant to p>agraph 7#a7 %all be assign$4 7ii7 ,sub/ances ( v high conc]n 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z a sub/ance ( v high conc]n any new *emical sub/ance t-- 7aa7 is toxic1 p]si/s 9 ! environm5t1 & is bioaccumulative2 or 7bb7 is highly haz>d\s4 7,,ii7 ,requirem5ts 7aa7 ,9 g5]al ,! ,adm9i/rator %all all[ ! submitt] ( a notice "u p>agraph 7#a77;,a7 = a new *emical sub/ance assign$ to ! category describ$ 9 ?is clause to manufacture or process ! new *emical sub/ance only 9 accordance ) p>agraph 7#a77;,c77ii74 7bb7 ,prohibition ,no o!r p]son may manufacture or process ! *emical sub/ance unless ! p]son has submitt$ a notice pursuant to p>agraph 7#a7 & ! requirem5ts ( p>agraph 7#a77;,c77ii7 h be5 met ) respect to t notice4 7iii7 ,sub/ances likely to meet ! safety /&>d 7,i7 ,9 g5]al 7aa7 ,! ,adm9i/rator %all designate z a sub/ance likely to meet ! safety /&>d any new *emical sub/ance t ! ,adm9i/rator det]m9es1 bas$ on available in=mation1 w\ld likely meet ! safety /&>d "u section #f7;d7-- 7,,aa7 = uses & "u conditions specifi$ by ! submitt] ( ! notice = ! new *emical sub/ance pursuant to p>agraph 7#a72 or 7,,bb7 = uses & "u additional conditions t c\ld be specifi$ by ! ,adm9i/rator 9 mak+ a safety /&>d det]m9ation = ! sub/ance4 7bb7 ,! ,adm9i/rator %all assign to ! category describ$ 9 item 7aa7 any new *emical sub/ance t meets ! crit]ia specifi$ 9 subclause 7,,ii7 or 7,,iii74 7,,ii7 ,sub/ances ( v l[ conc]n 7aa7 ,9 g5]al ,)9 ! category describ$ 9 subclause 7,i71 ! ,adm9i/rator %all designate z a sub/ance ( v l[ conc]n any new *emical sub/ance t1 bas$ on robu/ in=mation1 ! ,adm9i/rator det]m9es possesses intr9sic l[-haz>d prop]ties s t no fur!r action by ! ,adm9i/rator is w>rant$ unless & until ! ,adm9i/rator receives new in=mation t w>rants a diff]5t categorization ( ! *emical sub/ance4 7bb7 ,basis ( designation ,9 id5tify+ new *emical sub/ances to be plac$ 9 ! category describ$ 9 ?is subclause1 ! ,adm9i/rator %all base ! designation ( a new *emical sub/ance z a sub/ance ( v l[ conc]n on ! applicable m9imum in=mation set requir$ "u section #d1 unless ! ,adm9i/rator det]m9es t su* designation ( a p>ticul> new *emical sub/ance-- 7,,aa7 c be made to a high degree ( confid5ce bas$ on less in=mation2 or 7,,bb7 requires in=mation 9 addition to ! full m9imum in=mation set to address conflict+ or ambigu\s f9d+s1 9 :i* case ! ,adm9i/rator may require ! developm5t & submission ( ! additional in=mation4 7,,iii7 ,sub/ances to und]go safety /&>d det]m9ations ,)9 ! category describ$ 9 subclause 7,i71 ! ,adm9i/rator %all designate z a sub/ance to und]go a safety /&>d det]m9ation any new *emical sub/ance t ! ,adm9i/rator det]m9es1 bas$ on a scre5+ ( available use1 haz>d1 & exposure in=mation1 has in=mation available = ! *emical sub/ance t is suffici5tly robu/ to det]m9e t ! *emical sub/ance does n meet ! crit]ia = ! categories describ$ 9 subclause 7,,ii7 or clause 7ii7 or 7iv74 7,,iv7 ,requirem5t ,= a new *emical sub/ance designat$ z likely to meet ! safety /&>d pursuant to subclause 7,,ii7 or 7,,iii71 ! ,adm9i/rator %all1 ^u submission ( a notice ( comm5cem5t describ$ 9 subsection 7d7-- 7aa7 add ! *emical sub/ance to ! active inv5tory describ$ 9 section #h7;h77#a72 & 7bb7 = a *emical sub/ance designat$ to und]go a safety /&>d det]m9ation1 at ! discretion ( ! ,adm9i/rator acc\nt+ = tim+ ( ! submission & workload consid]ations1 add ! *emical sub/ance to ! curr5t bat* or hold ! sub/ance until ! next bat* ( sub/ances to be prioritiz$ 9 accordance ) section #f7;b77#d74 7,v7 ,manufactur+ & process+ ,p5d+ ! completion ( a safety /&>d det]m9ation "u section #f7;d71 a *emical sub/ance designat$ z a sub/ance likely to meet ! safety /&>d may be manufactur$ or process$ = uses & "u conditions specifi$ by ! ,adm9i/rator 9 det]m9+ t ! *emical sub/ance is likely to meet ! safety /&>d-- 7aa7 by ! submitt] ( ! notice = ! *emical sub/ance submitt$ pursuant to p>agraph 7#a77;,a71 ^u submission ( a notice = ! *emical sub/ance pursuant to subsection 7d72 7bb7 by o!r manufactur]s ( ! *emical sub/ance1 once ! *emical sub/ance has be5 plac$ on ! active inv5tory describ$ 9 section #h7;h77#a71 ^u submission ( a decl>ation = ! *emical sub/ance pursuant to section #h7;b77#a77;,b72 or 7cc7 by processors ( ! sub/ance1 ^u compliance ) ! requirem5ts ( section #h7;e74 7iv7 ,sub/ances ) insuffici5t in=mation 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z a sub/ance ) insuffici5t in=mation any new *emical sub/ance = :i* ! ,adm9i/rator concludes1 aft] ga!r+ & scre5+ available use1 haz>d1 & exposure in=mation1 t ne$$ in=mation = ! *emical sub/ance is n available1 is insuffici5t1 or is n ( suffici5t quality & reliability to all[ = an in=m$ categorization decision4 7,,ii7 ,requir$ submission ,= sub/ances designat$ "u ?is clause1 ! ,adm9i/rator %all require submission ( ! applicable m9imum in=mation set specifi$ "u section #d z ne$$ to in=m categorization decisionmak+ = new *emical sub/ances4 7,,iii7 ,recategorization ,foll[+ submission ( ! applicable m9imum in=mation set = ! *emical sub/ance pursuant to subclause 7,,ii71 ! ,adm9i/rator %all recategorize ! *emical sub/ance us+ ! categories & process describ$ 9 ?is p>agraph4 7,,iv7 ,prohibition ,not)/&+ p>agraph 7#a77;,c77ii71 no p]son may manufacture or process a *emical sub/ance designat$ "u ?is clause until & unless ! in=mation describ$ 9 subclause 7,,ii7 has be5 submitt$ & ! ,adm9i/rator has recategoriz$ ! sub/ance1 at :i* "t ! provisions applicable to ! category to :i* ! sub/ance has be5 assign$ %all apply4 7v7 ,sub/ances unlikely to meet ! safety /&>d 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z a sub/ance unlikely to meet ! safety /&>d any new *emical sub/ance t ! ,adm9i/rator det]m9es1 bas$ on available in=mation1 w\ld be unlikely to meet ! safety /&>d "u section #f7;d7-- 7aa7 = uses & "u conditions specifi$ by ! submitt] ( ! notice = ! *emical sub/ance pursuant to p>agraph 7#a72 or 7bb7 = o!r uses or "u additional conditions t ! ,adm9i/rator may evaluate 9 mak+ a safety /&>d det]m9ation = ! *emical sub/ance4 7,,ii7 ,prohibition ,except z provid$ "u clause 7ii71 no p]son may manufacture or process a *emical sub/ance designat$ "u ?is clause4 7c7 ,new uses ( exi/+ *emical sub/ances 7#a7 ,new uses ( exi/+ *emical sub/ances prior to safety /&>d det]m9ation 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 ) respect to an exi/+ *emical sub/ance = :i* ! ,adm9i/rator has n made a safety /&>d det]m9ation "u section #f7;d71 no p]son may manufacture or process ! *emical sub/ance-- 7i7 = a use t 0 n ongo+ on ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac2 or 7ii7 at a volume t is significantly increas$ f ! volume z ( ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac4 7,b7 ,exception ,a p]son may manufacture or process a *emical sub/ance 9 a mann] prohibit$ by subp>agraph 7,a7 if-- 7i7 ! p]son submits to ! ,adm9i/rator ! notice specifi$ 9 subsection 7g77#a77;,b72 7ii7 ! p]son complies ) subsection 7f72 & 7iii7 su* manufactur+ or process+ is consi/5t ) subsection 7b77#b77;,d77iii77,v74 7,c7 ,guidance ,n lat] ?an #ij days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all issue guidance = ! purpose ( id5tify+ :at con/itute new uses & significantly increas$ production volumes "u ?is p>agraph4 7#b7 ,new uses ( exi/+ *emical sub/ances t meet ! safety /&>d 7,a7 ,9 g5]al ,= an exi/+ *emical sub/ance = :i* ! ,adm9i/rator has det]m9$ "u section #f7;d7 t ! manufactur]s & processors ( ! *emical sub/ance h e/abli%$ t ! sub/ance meets ! applicable safety /&>d1 no p]son may manufacture1 process1 di/ribute 9 comm]ce1 use1 or dispose ( ! *emical sub/ance1 or a mixture or article conta9+ ! *emical sub/ance = uses1 at production volumes1 or 9 mann]s o!r ?an ^? ! ,adm9i/rator specifi$ 9 ! safety /&>d det]m9ation1 unless-- 7i7 ! p]son submits to ! ,adm9i/rator a notice 9 accordance ) subsection 7g77#a77;,c7 ( ! int5tion ( ! p]son to manufacture1 process1 di/ribute 9 comm]ce1 use1 or dispose ( ! *emical sub/ance1 or a mixture or article conta9+ ! *emical sub/ance1 = ! new use or at a new production volume1 or 9 su* o!r mann] t is inconsi/5t ) a specifi$ condition or t]m 9 ! safety /&>d det]m9ation made by ! ,adm9i/rator = t sub/ance2 & 7ii7 ! ,adm9i/rator det]m9es t ! p]son submitt+ ! notice has e/abli%$ t ! *emical sub/ance w cont9ue to meet ! safety /&>d if ! all[$ uses1 production volumes1 or o!r specifi$ conditions or t]ms = t sub/ance1 are revis$ to encompass ! new use1 new production volume1 or o!r mann] ( manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal4 7,b7 ,am5dm5t to safety /&>d det]m9ation ,if ! conditions describ$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a7 are satisfi$1 ! ,adm9i/rator %all1 by ord]1 am5d ! safety /&>d det]m9ation = ! *emical sub/ance to include ! new use1 production volume1 or o!r mann] ( manufactur+ or process+ among ! all[$ uses1 production volumes1 or mann]s ( manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( ! *emical sub/ance4 7,c7 ,safety /&>d det]m9ation 7i7 ,9 g5]al ,except z provid$ 9 clauses 7ii7 & 7iii71 n lat] ?an #ahj days aft] ! date ( receipt ( a notice pursuant to subp>agraph 7,a77i71 ! ,adm9i/rator %all det]m9e :e!r ! p]son submitt+ ! notice has e/abli%$ t ! *emical sub/ance w cont9ue to meet ! safety /&>d "u section #f7;d74 7ii7 ,ext5sion ,! ,adm9i/rator may ext5d ! det]m9ation deadl9e "u clause 7i7 by #a or m additional p]iods n to exce$ #a ye> 9 ! aggregate1 9 su* mann] z ! ,adm9i/rator det]m9es necess>y4 7iii7 ,failure to make a timely det]m9ation ,! failure ( ! ,adm9i/rator to make a timely det]m9ation 9 accordance ) ?is p>agraph %all n be suffici5t to satisfy subp>agraph 7,a77ii74 7d7 ,notice ( comm5cem5t 7#a7 ,9 g5]al ,n lat] ?an #cj days aft] ! date on :i* a manufactur] or processor comm5ces manufactur+ or process+ ( a new *emical sub/ance1 ! manufactur] or processor %all submit to ! ,adm9i/rator a notice ( comm5cem5t ( manufacture or process+4 7#b7 ,requirem5ts ,! notice ( comm5cem5t %all-- 7,a7 be consid]$ equival5t to ! decl>ation requir$ "u subp>agraph 7,a7 or 7,c7 ( section #h7;b77#b72 & 7,b7 include ! in=mation describ$ 9 section #h7;b77#e74 7#c7 ,)drawal ,a p]son :o has submitt$ a notice = a *emical sub/ance "u subsection 7b7 or 7c71 & has n comm5c$ ) manufacture or process+ ( ! sub/ance1 may )draw ! notice4 7e7 ,*emical sub/ances exhibit+ special sub/ance *>act]i/ics 7#a7 ,det]m9ation ,! ,adm9i/rator %all det]m9e by ord] or rule t a v>iant ( a *emical sub/ance exhibit+ #a or m special sub/ance *>act]i/ics-- 7,a7 is a use t is sep>ate f any use ( ! *emical sub/ance t does n exhibit ! special sub/ance *>act]i/ics2 or 7,b7 is a di/9ct *emical sub/ance4 7#b7 ,requirem5ts = v>iants t are sep>ate uses ,9 ! case ( a *emical sub/ance t ! ,adm9i/rator det]m9es to be a sep>ate use bas$ on ! special sub/ance *>act]i/ics ( ! *emical sub/ance1 ! manufactur] or processor %all satisfy su* fur!r conditions z ! ,adm9i/rator e/abli%es1 by ord] or rule4 7#c7 ,requirem5ts = v>iants t are di/9ct *emical sub/ances ,9 ! case ( a *emical sub/ance t ! ,adm9i/rator det]m9es to be a di/9ct *emical sub/ance bas$ on ! special sub/ance *>act]i/ics ( ! *emical sub/ance1 & t is n li/$ on ! active inv5tory e/abli%$ "u section #h7;h77#a71 ! manufactur] or processor %all comply ) ! requirem5ts ( subsection 7b74 7f7 ,submission ( data 7#a7 ,9 g5]al ,a p]son %all submit to ! ,adm9i/rator data 9 accordance ) ! rule or ord] at ! "t t notice is submitt$ "u subsection 7b7 or 7c7 if ! p]son is requir$ to submit to ! ,adm9i/rator-- 7,a7 "u subsection 7b7 or 7c71 a notice prior to beg9n+ ! manufacture or process+ ( a *emical sub/ance2 & 7,b7 "u section #d7;b71 te/ data = ! *emical sub/ance prior to ! submission ( ! notice4 7#b7 ,availability ,subject to section #ad1 ! ,adm9i/rator %all make any te/ data submitt$ "u p>agraph 7#a7 available on a publicly accessible ,int]net site4 7#c7 ,tim+ ,except z provid$ "u subsection 7b77#b77;,d77iv71 ! ,adm9i/rator may require a p]son subject to an in=mation requirem5t = a *emical sub/ance "u ?is subsection or section #d to submit ! in=mation-- 7,a7 prior to & z a condition ( ! ,adm9i/rator assign+ ! sub/ance to a category2 7,b7 z a condition ( comm5cem5t ( manufacture or process+2 or 7,c7 z a condition ( exce$+ a specifi$ manufactur+ volume or exp&+ use ( ! sub/ance4 7g7 ,cont5t & availability ( notice 7#a7 ,cont5t 7,a7 ,new *emical sub/ances ,a notice "u subsection 7b77#a7 %all include-- 7i7 ! *emical id5tity & any special sub/ance *>act]i/ics ( ! *emical sub/ance2 7ii7 ! id5tity & prim>y bus9ess location ( ! manufactur]2 7iii7 ! in=mation describ$ 9 section #h7;h77#e77;,b77ii72 7iv7 ! m9imum in=mation set describ$ 9 section #d7;a71 :]e applicable2 & 7v7 a /atem5t t-- 7,i7 ! new *emical sub/ance is likely to meet ! safety /&>d "u section #f7;d72 or 7,,ii7 ! #a or m uses propos$ = ! new *emical sub/ance meet ! crit]ia describ$ 9 section #f7;h77#b77;,b74 7,b7 ,new uses ( exi/+ *emical sub/ances prior to safety /&>d det]m9ation ,a notice "u subsection 7c77#a7 %all include all updates to ! decl>ation describ$ 9 section #h7;b77#b7 & in=mation describ$ 9 section #h7;h77#e77;,b77ii7 t is relevant to ! new use1 new production volume1 or o!r new mann] ( manufactur+ or process+4 7,c7 ,new uses ( exi/+ *emical sub/ances t meet ! safety /&>d ,a notice "u subsection 7c77#b7 %all include-- 7i7 all updates to ! decl>ation describ$ 9 section #h7;b77#b72 7ii7 in=mation describ$ 9 section #h7;h77#e77;,b77ii7 t is relevant to ! new use1 new production volume1 or o!r new mann] ( manufactur+ or process+2 7iii7 all updates to ! m9imum in=mation set describ$ 9 section #d7;a7 relevant to ! new use1 new production volume1 or o!r new mann] ( manufactur+ or process+2 & 7iv7 a /atem5t t ! *emical sub/ance w cont9ue to meet ! safety /&>d if ! all[$ uses1 production volumes1 or o!r specifi$ conditions or t]ms = t *emical sub/ance are revis$ to encompass ! new use1 production volume1 or o!r mann] ( manufactur+ or process+4 7#b7 ,availability ,subject to section #ad1 ! ,adm9i/rator %all make ! notices "u p>agraph 7#a7 available on a publicly accessible ,int]net site4 7#c7 ,public in=mation ,subject to section #ad1 n lat] ?an #e days 7exclud+ ,saturdays1 ,sundays1 & legal holidays7 aft] ! date ( ! receipt ( a notice "u subsection 7b71 7c71 or 7d71 or ( data "u subsection 7f71 ! ,adm9i/rator %all make available on a publicly accessible ,int]net site a notice t-- 7,a7 id5tifies ! *emical sub/ance = :i* notice or in=mation has be5 receiv$2 7,b7 li/s ! uses or int5d$ uses ( ! *emical sub/ance2 7,c7 = sub/ances = :i* a notice is submitt$ "u subsection 7b77#a71 is promptly updat$ to specify ! category to :i* ! ,adm9i/rator has assign$ ! sub/ance pursuant to subsection 7b77#b7 once ! assignm5t has be5 made2 7,d7 9 ! case ( ! receipt ( data "u subsection 7f71 describes-- 7i7 ! nature ( ! te/s p]=m$ ) respect to ! *emical sub/ance2 & 7ii7 any data t 7 receiv$ "u subsection 7f7 or a rule or ord] "u section #d2 & 7,e7 ref]5ces ! availability ( ! m9imum in=mation set1 :]e applicable4 7#d7 ,li/ ( notices ,at ! beg9n+ ( ea* mon?1 ! ,adm9i/rator %all make available on a publicly accessible ,int]net site a li/ ( ea* *emical sub/ance = :i* a notice has be5 receiv$ "u subsection 7b71 7c71 or 7d74 7h7 ,exemptions 7#a7 ,intr9sically safe sub/ances 7,a7 ,exemption 7i7 ,9 g5]al ,if ! ,adm9i/rator det]m9es t sci5tific cons5sus exi/s t ! intr9sic prop]ties ( a new *emical sub/ance are su* t ! *emical sub/ance does n & w\ld n pose any risk ( injury to human heal? or ! environm5t "u any int5d$ or reasonably anticipat$ levels ( production1 patt]ns ( use1 or exposures aris+ at any /age across ! lifecycle ( ! *emical sub/ance1 ! ,adm9i/rator may1 by ord]1 exempt ! *emical sub/ance1 or p>ticul> uses ( su* sub/ances1 f #a or m ( ! requirem5ts ( ?is section4 7ii7 ,basis ( det]m9ation ,a det]m9ation "u clause 7i7-- 7,i7 %all be bas$ on consid]ation ( ! intr9sic prop]ties ( ! *emical sub/ance2 & 7,,ii7 %all n be bas$ on f9d+s or assumptions ( l[ human or environm5tal exposure to su* sub/ances4 7,b7 ,notice ( det]m9ation & exemption ,n lat] ?an #cj days aft] provid+ an exemption pursuant to subp>agraph 7,a71 ! ,adm9i/rator %all publi% 9 ! ,f$]al ,regi/] a notice t-- 7i7 subject to section #ad1 provides ! specific id5tity ( ! *emical sub/ance or category2 7ii7 if a p>ticul> use ( ! *emical sub/ance is exempt$ "u subp>agraph 7,a71 describes ! p>ticul> use ( ! *emical sub/ance t ! ,adm9i/rator has exempt$2 & 7iii7 expla9s & docum5ts ! basis = ! det]m9ation & exemption ( ! ,adm9i/rator4 7,c7 ,reconsid]ation ( exemption 7i7 ,9 g5]al ,! ,adm9i/rator may reconsid] & revoke or modify any exemption provid$ "u subp>agraph 7,a7 at any "t if ! ,adm9i/rator det]m9es t-- 7,i7 ! conditions specifi$ 9 subp>agraph 7,a7 are no long] met2 or 7,,ii7 su* action is necess>y to protect human heal? or ! environm5t or is o!rwise 9 ! public int]e/4 7ii7 ,publication ,9 ! ev5t ( a revocation or modification "u clause 7i71 ! ,adm9i/rator %all publi% a notice ( ! gr\nds = ! revocation4 7,d7 ,prior regulatory exemptions 7i7 ,review 7,i7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all review exemptions t 7 grant$ pursuant to subsection 7h77#d7 ( ?is section z 9 effect on ! day be=e t date ( enactm5t4 7,,ii7 ,effect ( exemption ,an exemption describ$ 9 subclause 7,i7 %all cont9ue to be 9 effect until ! date on :i* ! ,adm9i/rator det]m9es1 by ord]1 t-- 7aa7 ! exemption is n appropriate "u ?is section1 at :i* "t ! exemption %all cease to be 9 effect2 or 7bb7 ! exemption is appropriate "u ?is section1 at :i* "t ! ,adm9i/rator may issue an ord] to modify or cont9ue 9 effect ! exemption pursuant to subp>agraph 7,a74 7ii7 ,polym]ic *emical sub/ances ,not)/&+ subp>agraph 7,a7 & any previ\sly issu$ exemption applicable to polym]ic *emical sub/ances-- 7,i7 subsection 7d7 %all apply to new polym]ic *emical sub/ances eligible = ! previ\sly issu$ exemption-- 7aa7 dur+ ! p]iod prior to a det]m9ation by ! ,adm9i/rator pursuant to clause 7i7 applicable to su* sub/ances2 & 7bb7 aft] a det]m9ation by ! ,adm9i/rator pursuant to clause 7i77,,ii77bb7 t cont9uation ( ! prior exemption is appropriate = "s or all su* sub/ances1 = su* sub/ances to :i* ! cont9uation applies2 & 7,,ii7 all ( ?is section %all apply to new polym]ic *emical sub/ances eligible = ! previ\sly issu$ exemption aft] a det]m9ation by ! ,adm9i/rator pursuant to clause 7i77,,ii77aa7 t cont9uation ( ! prior exemption is n appropriate = "s or all su* sub/ances1 = su* sub/ances to :i* ! det]m9ation applies4 7,e7 ,no limitation on au?ority ,no?+ 9 ?is p>agraph limits or o!rwise affects ! au?ority ( ! ,adm9i/rator "u any o!r provision ( ?is ,act4 7#b7 ,te/ m>ket+ purposes ,subject to p>agraph 7#f71 ! ,adm9i/rator may1 ^u application1 exempt any p]son f any requirem5t ( subsection 7b71 7c71 or 7f7 to p]mit ! p]son to manufacture or process a *emical sub/ance = te/ m>ket+ purposes-- 7,a7 ^u a %[+ by ! p]son1 9 a mann] t ! ,adm9i/rator det]m9es1 t ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 & disposal ( ! *emical sub/ance 7includ+ any comb9ation ( ^? activities7 w n endang] human heal? or ! environm5t2 & 7,b7 "u su* re/rictions z ! ,adm9i/rator consid]s appropriate4 7#c7 ,equival5t *emical sub/ances 7,a7 ,9 g5]al ,! ,adm9i/rator %all1 ^u application1 fully or p>tially exempt any p]son f ! requirem5t to submit any data "u subsection 7b7 or 7f7 if1 on receipt ( an application1 ! ,adm9i/rator det]m9es t-- 7i7 ! *emical sub/ance = :i* ! application 0 submitt$ is equival5t to a *emical sub/ance = :i* data has be5 submitt$ to ! ,adm9i/rator z requir$ by ?is ,act2 & 7ii7 submission ( data by ! applicant on ! *emical sub/ance w\ld be duplicative ( data :i* has be5 submitt$ to ! ,adm9i/rator 9 accordance ) ?is ,act4 7,b7 ,effective date ,no exemption "u ?is p>agraph may take effect be=e ! beg9n+ ( ! reimbursem5t p]iod applicable to ! data4 7,c7 ,fair & equitable reimbursem5t 7i7 ,def9ition ( reimbursem5t p]iod ,9 ?is subp>agraph1 ! t]m reimbursem5t p]iod1 ) respect to any previ\sly submitt$ data = a *emical sub/ance1 means a p]iod-- 7,i7 beg9n+ on ! date ( ! t]m9ation ( ! prohibition1 impos$ "u ?is section1 on ! manufacture or process+ ( ! *emical sub/ance by ! p]son :o submitt$ ! data to ! ,adm9i/rator2 & 7,,ii7 end+ on ! lat] (-- 7aa7 ! date t is #e ye>s aft] ! date ref]r$ to 9 subclause 7,i72 or 7bb7 ! expiration ( ! p]iod1 :i* beg9s on ! date ref]r$ to 9 subclause 7,i7 & is equal to ! p]iod t ! ,adm9i/rator det]m9es to be necess>y to develop ! data4 7ii7 ,reimbursem5t ,except z provid$ 9 clause 7iii71 if ! ,adm9i/rator exempts any p]son1 "u subp>agraph 7,a71 & ! exemption is grant$ dur+ ! reimbursem5t p]iod = t data1 ! ,adm9i/rator %all ord] ! p]son grant$ ! exemption to provide fair & equitable reimbursem5t 79 an am\nt det]m9$ by ! ,adm9i/rator7-- 7,i7 to ! p]son :o previ\sly submitt$ ! data on :i* ! exemption 0 bas$1 = a portion ( ! co/s incurr$ by ! p]son 9 comply+ ) ! requirem5t "u ?is title to submit ! data2 & 7,,ii7 to any o!r p]son :o has be5 requir$ "u ?is subp>agraph to contribute ) respect to ! co/s1 = a portion ( ! am\nt ! p]son 0 requir$ to contribute4 7iii7 ,exception ,clause 7ii7 %all n apply if ! p]son exempt$ "u t clause & ! p]sons describ$ 9 subclauses 7,i7 & 7,,ii7 ( t clause agree on ! am\nt & me?od ( reimbursem5t4 7iv7 ,consid]ations ,9 promulgat+ rules = ! det]m9ation ( fair & equitable reimbursem5t to ! p]sons describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7ii7 = co/s incurr$ ) respect to a *emical sub/ance1 ! ,adm9i/rator %all1 aft] consultation ) ! ,attorney ,g5]al & ! ,f$]al ,trade ,commission1 consid] all relevant factors1 includ+-- 7,i7 ! effect on ! competitive position ( ! p]son requir$ to provide reimbursem5t 9 relation to ! p]sons to be reimburs$2 & 7,,ii7 ! %>e ( ! m>ket = ! *emical sub/ance ( ! p]son requir$ to provide reimbursem5t to ! %>e ( ! m>ket ( ! p]sons to be reimburs$4 7#d7 ,small quantities solely = exp]im5tation1 rese>*1 & analysis 7,a7 ,9 g5]al ,if ! conditions describ$ 9 subp>agraph 7,b7 are met1 subsections 7b71 7c71 & 7f7 %all n apply ) respect to ! manufactur+ or process+ ( any *emical sub/ance t is manufactur$ or process$1 or propos$ to be manufactur$ or process$1 only 9 small quantities 7z def9$ by ! ,adm9i/rator by rule7 solely = purposes (-- 7i7 sci5tific exp]im5tation or analysis2 or 7ii7 *emical rese>* on1 or analysis ( ! *emical sub/ance or ano!r *emical sub/ance1 includ+ su* rese>* or analysis = ! developm5t ( a product4 7,b7 ,conditions ,all p]sons engag$ 9 ! exp]im5tation1 rese>*1 or analysis = a manufactur] or processor %all be notifi$ 79 su* =m & mann] z ! ,adm9i/rator may prescribe7 ( any risk to human heal? t ! manufactur]1 processor1 or ! ,adm9i/rator has reason to believe may be associat$ ) t *emical sub/ance4 7#e7 ,tempor>y exi/5ce ,subject to p>agraph 7#f71 ! ,adm9i/rator may1 ^u application1 exempt f subsections 7b71 7c71 & 7f7 ! manufactur+ or process+ ( any *emical sub/ance-- 7,a7 t exi/s tempor>ily z a result ( a *emical reaction 9 ! manufactur+ or process+ ( a mixture or ano!r *emical sub/ance2 & 7,b7 to :i* !re is no1 & w n be1 human or environm5tal exposure4 7#f7 ,publication 7,a7 ,9 g5]al ,z soon z practicable aft] ! date ( receipt ( an application "u p>agraph 7#b7 or 7#e71 ! ,adm9i/rator %all publi% 9 ! ,f$]al ,regi/] notice ( ! receipt ( ! application4 7,b7 ,requirem5ts ,! ,adm9i/rator %all-- 7i7 give int]e/$ p]sons an opportunity to comm5t ^u any application describ$ 9 subp>agraph 7,a72 7ii7 n lat] ?an #de days aft] ! date ( receipt ( an application1 approve or d5y ! application2 & 7iii7 publi% 9 ! ,f$]al ,regi/] notice ( ! approval or d5ial ( ! application4 7i7 ,c]tification ,ea* submission requir$ "u ?is section or "u a rule or an ord] promulgat$ or issu$ by ! ,adm9i/rator "u ?is section %all be accompani$ by a c]tification sign$ by a responsible (ficial ( ! manufactur] or processor t ea* /atem5t conta9$ 9 ! submission-- 7#a7 is accurate & reliable2 & 7#b7 includes all mat]ial facts requir$ by ! applicable provision ( ?is section or rule or ord] "u ?is section4 4 #g4 ,bat*+1 categorization1 prioritization1 safety /&>d det]m9ation1 & risk managem5t 7a7 ,9 g5]al ,section #f ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfje7 is am5d$-- 7#a7 by /rik+ subsection 7f72 7#b7 by r$esignat+ subsection 7e7 z subsection 7i72 7#c7 by /rik+ ! section head+ & designation & all t foll[s ?r\gh subsection 7d7 & ins]t+ ! foll[+3 #f4 ,bat*+1 categorization1 prioritization1 safety /&>d det]m9ation1 & risk managem5t 7a7 ,bat*+ 7#a7 ,9 g5]al ,to ensure t an effici5t & ord]ly process & pace is e/abli%$ = ! det]m9ation ( safety ( *emical sub/ances 9 comm]ce & ! application ( risk managem5t measures z ne$$1 ! ,adm9i/rator %all e/abli% a sy/em = assign+ *emical sub/ances into bat*es 9 accordance ) ?is subsection4 7#b7 ,requirem5ts 7,a7 ,tim+ ,n lat] ?an #bgj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 & n less frequ5tly ?an once e #e ye>s !reaft] until all *emical sub/ances li/$ on ! active portion ( ! inv5tory e/abli%$ "u section #h7;h77#a7 h be5 assign$ to a bat*1 ! ,adm9i/rator %all assign *emical sub/ances on ! active portion ( ! inv5tory to bat*es ( *emical sub/ances "u ?is subsection4 7,b7 ,numb] ,ea* bat* e/abli%$ "u ?is subsection %all include a numb] ( *emical sub/ances approximately equal to ! numb] ( *emical sub/ances = :i* reports are submitt$ to ! ,adm9i/rator "u ! *emical data report+ rule z ( ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac4 7,c7 ,publication ,! ,adm9i/rator %all publi%1 subject to section #ad1 ! li/ ( *emical sub/ances assign$ to ea* bat* promptly on designation ( ! *emical sub/ances to ! bat*4 7#c7 ,initial bat* 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! initial bat* ( *emical sub/ances designat$ "u p>agraph 7#b77;,a7 %all include ! *emical sub/ances = :i* reports are submitt$ to ! ,adm9i/rator "u ! *emical data report+ rule z ( ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac4 7,b7 ,inclusions & exclusions ,not)/&+ subp>agraph 7,a71 ! ,adm9i/rator may-- 7i7 include 9 ! initial bat* *emical sub/ances t-- 7,i7 are manufactur$ at volumes bel[ ! ?re%old us$ "u ! *emical data report+ rule to designate *emical sub/ances subject to basic report+ "u t rule2 b 7,,ii7 are us$ or releas$ into ! environm5t 9 a mann] t ! ,adm9i/rator det]m9es w>rants e>ly evaluation2 & 7ii7 exclude f ! initial bat* *emical sub/ances t-- 7,i7 are report$ to ! ,adm9i/rator "u ! *emical data report+ rule2 b 7,,ii7 are us$ or releas$ into ! environm5t 9 a mann] t ! ,adm9i/rator det]m9es does n w>rant e>ly evaluation4 7#d7 ,subsequ5t bat*es ,! ,adm9i/rator %all assign *emical sub/ances to subsequ5t bat*es 9 a mann] t ! ,adm9i/rator det]m9es reflects ! ext5t to :i* ! *emical sub/ances w>rant e>li] or lat] evaluation4 7b7 ,categorization & prioritization 7#a7 ,regulations ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all promulgate regulations t-- 7,a7 e/abli% ! categories & specify ! process & crit]ia ! ,adm9i/rator w use to categorize *emical sub/ances1 :i* %all be consi/5t ) p>agraph 7#c77;,b71 beg9n+ ) ^? *emical sub/ances assign$ to ! initial bat* describ$ 9 subsection 7a77#c72 7,b7 designate ! process & crit]ia ! ,adm9i/rator w use to prioritize *emical sub/ances t are plac$ 9 ! category ( *emical sub/ances to und]go safety /&>d det]m9ations1 :i* %all be consi/5t ) ! priorities describ$ 9 p>agraph 7#d72 7,c7 describe h[ ! categorization & prioritization process & crit]ia relate to1 & take into acc\nt1 ! categorization & prioritization decisions made 9 o!r jurisdictions1 includ+ ,/ates & =eign gov]nm5ts2 & 7,d7 describe crit]ia & factors ! ,adm9i/rator w use to weigh evid5ce & assess ! quality & reliability ( in=mation us$ to in=m categorization & prioritization decisions4 7#b7 ,in=mation s\rces 7,a7 ,9 g5]al ,9 mak+ categorization & prioritization decisions1 ! ,adm9i/rator %all take into consid]ation in=mation reg>d+ *emical sub/ances t is available to ! ,adm9i/rator at ! "t ! decisions are made1 includ+ in=mation t is-- 7i7 receiv$ by ! ,adm9i/rator f manufactur]s or processors pursuant to requirem5ts "u section #h7;b7 & 7c72 7ii7 includ$ 9 any m9imum in=mation set requir$ "u section #d2 7iii7 submitt$ to ! ,adm9i/rator t is relevant to ! categorization or prioritization ( ! *emical sub/ance2 & 7iv7 id5tifi$ ?r\gh an active se>* by ! ,adm9i/rator ( in=mation s\rces t are publicly available or o!rwise accessible to ! ,adm9i/rator4 7,b7 ,in=mation f manufactur]s & processors 7i7 ,9 g5]al ,subject to clause 7ii71 on designation by ! ,adm9i/rator "u p>agraph 7#c77;,b77iii7 ( a *emical sub/ance safety /&>d det]m9ation1 any manufactur] or processor ( a designat$ *emical sub/ance & any trade association or volunt>y consortium t repres5ts a manufactur] or processor ( a designat$ *emical sub/ance may provide to ! ,adm9i/rator in=mation t-- 7,i7 relates to ! *emical sub/ances manufactur$ or process$ by ! applicable manufactur] or processor2 7,,ii7 is 9 ! possession (1 or kn[n to1 ! manufactur]1 processor1 trade association1 or consortium2 & 7,,iii7 is n already available to ! ,adm9i/rator4 7ii7 ,requirem5t ,if a manufactur]1 processor1 trade association1 or consortium elects to provide in=mation to ! ,adm9i/rator "u clause 7i71 ! manufactur]1 processor1 trade association1 or consortium %all provide all relevant in=mation 9 ! possession (1 or kn[n to1 ! manufactur]1 processor1 trade association1 or consortium = ea* *emical sub/ance designat$ by ! ,adm9i/rator t is manufactur$ or process$ by ! applicable manufactur] or processor4 7iii7 ,me?od ( submission ,in=mation describ$ 9 ?is subp>agraph may be submitt$ to ! ,adm9i/rator by-- 7,i7 a manufactur] or processor-- 7aa7 on an individual basis2 or 7bb7 ?r\gh a trade association or volunt>y consortium2 & 7,,ii7 a trade association or volunt>y consortium t has develop$ relevant in=mation on behalf ( ! manufactur]s or processors ( designat$ *emical sub/ances repres5t$ by ! trade association or volunt>y consortium4 7#c7 ,categorization ( *emical sub/ances 7,a7 ,tim+ 7i7 ,initial bat* ,n lat] ?an #ahj days aft] ! date ( promulgation ( regulations pursuant to p>agraph 7#a71 ! ,adm9i/rator %all publi%1 subject to section #ad1 ! category assignm5ts = ! initial bat* ( *emical sub/ances id5tifi$ "u subsection 7a77#c71 us+ ! categories describ$ 9 subp>agraph 7,b74 7ii7 ,subsequ5t bat*es ,n lat] ?an #ahj days aft] ! date on :i* ! ,adm9i/rator designates ea* subsequ5t bat* ( *emical sub/ances "u subsection 7a77#b77;,a71 ! ,adm9i/rator %all publi% ! category assignm5ts = ! *emical sub/ances 9 ! bat*4 7,b7 ,categories ,! regulation promulgat$ pursuant to p>agraph 7#a7 %all incorporate1 e/abli% crit]ia =1 & fur!r specify z ne$$1 ! foll[+ categories into :i* *emical sub/ances 9 ea* bat* %all be plac$3 7i7 ,sub/ances ( v high conc]n 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z sub/ances ( v high conc]n ^? *emical sub/ances-- 7aa7 = :i* !re is evid5ce ( widespread exposure & t-- 7,,aa7 are toxic1 p]si/ 9 ! environm5t1 & are bioaccumulative2 or 7,,bb7 are highly haz>d\s2 or 7bb7 t are subject to regulation "u section #f or #g ( ?is ,act 7z 9 effect on ! day be=e ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac74 7,,ii7 ,in=mation set ,a m9imum in=mation set1 z specifi$ "u section #d1 ne$ n be submitt$ or o!rwise available = a *emical sub/ance to be designat$ a sub/ance ( v high conc]n "u ?is clause4 7ii7 ,sub/ances ( v l[ conc]n 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z sub/ances ( v l[ conc]n ^? *emical sub/ances t1 bas$ on robu/ in=mation1 ! ,adm9i/rator det]m9es possess intr9sic l[-haz>d prop]ties su* t no fur!r action by ! ,adm9i/rator is w>rant$1 unless ! ,adm9i/rator receives new in=mation t w>rants a diff]5t categorization ( ! *emical sub/ance4 7,,ii7 ,factors = consid]ation ,9 designat+ *emical sub/ances to be plac$ 9 ! v l[ conc]n category "u ?is clause1 ! ,adm9i/rator %all-- 7aa7 take into consid]ation :e!r *emical sub/ances 9 comm]ce h receiv$1 z ( ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 exemptions "u section #e ( ?is ,act 7z 9 effect on ! day be=e ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac7 bas$ on anticipat$ l[ intr9sic haz>d2 & 7bb7 9 g5]al1 base ! designation on a m9imum in=mation set z requir$ "u section #d1 unless ! ,adm9i/rator det]m9es t su* designation ( a p>ticul> *emical sub/ance-- 7,,aa7 c be made to a high degree ( confid5ce bas$ on less in=mation2 or 7,,bb7 requires in=mation 9 addition to ! full m9imum in=mation set to address conflict+ or ambigu\s f9d+s1 9 :i* case ! ,adm9i/rator may require ! developm5t & submission ( ! additional in=mation4 7iii7 ,sub/ances to und]go safety /&>d det]m9ations ,! ,adm9i/rator %all designate z sub/ances to und]go safety /&>d det]m9ations ^? *emical sub/ances t ! ,adm9i/rator det]m9es-- 7,i7 bas$ on a scre5+ ( available use1 haz>d1 & exposure in=mation1 d n meet ! crit]ia = ! categories describ$ 9 clauses 7i7 & 7ii72 & 7,,ii7 are ! subject ( available in=mation t is suffici5tly robu/ to in=m prioritization decisions to be made = ! *emical sub/ances "u p>agraph 7#d74 7iv7 ,sub/ances ) insuffici5t in=mation 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z sub/ances ) insuffici5t in=mation ^? *emical sub/ances = :i* ! ,adm9i/rator det]m9es1 aft] ga!r+ & scre5+ available use1 haz>d1 & exposure in=mation1 t in=mation is n available1 is insuffici5t1 or is n ( suffici5t quality & reliability to all[ = an in=m$ categorization decision4 7,,ii7 ,m9imum in=mation set 7aa7 ,9 g5]al ,= *emical sub/ances designat$ "u ?is clause1 ! ,adm9i/rator %all require submission ( ! applicable m9imum in=mation set specifi$ "u section #d z ne$$ to in=m categorization decisionmak+4 7bb7 ,tim+ ,! m9imum in=mation set %all be submitt$ to ! ,adm9i/rator-- 7,,aa7 n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac = ! initial bat* ( *emical sub/ances id5tifi$ "u subsection 7a77#c72 & 7,,bb7 n lat] ?an #e ye>s aft] ! assignm5t ( a *emical sub/ance to ! category "u ?is clause = subsequ5t bat*es4 7,,iii7 ,recategorization 7aa7 ,9 g5]al ,aft] submission ( ! m9imum in=mation set = a *emical sub/ance pursuant to subclause 7,i71 ! ,adm9i/rator %all recategorize ! *emical sub/ance us+ ! categories & process describ$ 9 ?is p>agraph4 7bb7 ,discretion ( ,adm9i/rator ,! ,adm9i/rator1 tak+ into acc\nt ! tim+ ( ! submission & workload consid]ations1 may-- 7,,aa7 add a *emical sub/ance to a curr5t bat*2 or 7,,bb7 hold ! *emical sub/ance until ! next bat* ( *emical sub/ances = recategorization4 7v7 ,designation to only #a category ,a *emical sub/ance %all n be simultane\sly 9 m ?an #a ( ! categories designat$ "u clause 7i7 ?r\gh 7iv74 7#d7 ,prioritization ( *emical sub/ances 7,a7 ,tim+ 7i7 ,initial bat* ,n lat] ?an #bgj days aft] ! date ( promulgation ( regulations pursuant to p>agraph 7#a71 ! ,adm9i/rator %all publi%1 subject to section #ad1 ! priority class assignm5ts1 us+ ! priority classes describ$ 9 subp>agraph 7,b71 = ! *emical sub/ances 9 ! initial bat* ( *emical sub/ances id5tifi$ "u subsection 7a77#c7 t ! ,adm9i/rator has assign$ to ! category ( *emical sub/ances to und]go safety /&>d det]m9ations4 7ii7 ,subsequ5t bat*es ,n lat] ?an #bgj days aft] ! date on :i* ! ,adm9i/rator designates ea* subsequ5t bat* ( *emical sub/ances "u subsection 7a77#b77;,a71 ! ,adm9i/rator %all publi% ! priority class assignm5ts = ! *emical sub/ances 9 ! bat* t ! ,adm9i/rator has assign$ to ! category ( *emical sub/ances to und]go safety /&>d det]m9ations4 7,b7 ,crit]ia ,! crit]ia us$ by ! ,adm9i/rator to assign *emical sub/ances to priority classes %all take into acc\nt-- 7i7 pot5tial impacts ( ! *emical sub/ance on human heal? & ! environm5t2 7ii7 ! haz>d pot5tial ( ! *emical sub/ance1 includ+ classifications & designations ( haz>d *>act]i/ics by o!r au?oritative entities2 7iii7 ! pot5tial = exposure to ! *emical sub/ance2 & 7iv7 measurem5ts ( exposure = a giv5 pa?way ( exposure1 if available & reliable1 9 pref]5ce to less direct indicators (1 or surrogates =1 exposure pot5tial = ! same pa?way4 7,c7 ,priority classes ,! regulations promulgat$ pursuant to p>agraph 7#a7 %all e/abli% ! foll[+ priority classes & crit]ia1 & fur!r specify ! process ! ,adm9i/rator w use to assign to ! priority classes ! *emical sub/ances 9 ea* bat* t ! ,adm9i/rator has assign$ to ! category ( *emical sub/ances to und]go safety /&>d det]m9ations3 7i7 ,priority ,class #a 7,i7 ,9 g5]al ,9 ea* bat*1 ! ,adm9i/rator %all designate z ,priority ,class #a ^? *emical sub/ances t ! ,adm9i/rator det]m9es w>rant safety /&>d det]m9ations 9 ! ne> t]m4 7,,ii7 ,initial assignm5t ,! ,adm9i/rator %all 9 ea* bat* initially designate z ,priority ,class #a *emical sub/ances t possess relatively great] haz>d pot5tial & = :i* !re is evid5ce ( m significant or widespread exposure4 7,,iii7 ,reassignm5t ,z safety /&>d det]m9ations = ! *emical sub/ance are complet$1 ! ,adm9i/rator may designate z ,priority ,class #a any *emical sub/ance initially assign$ to a l[] priority class1 includ+ *emical sub/ances-- 7aa7 pos+ significant haz>d conc]ns b ( less or unkn[n exposure conc]n2 7bb7 pos+ significant exposure conc]n b ( less or unkn[n haz>d conc]n2 or 7cc7 pos+ less haz>d & exposure conc]ns4 7,,iv7 ,factors = consid]ation ,9 det]m9+ ! numb] ( *emical sub/ances to be plac$ 9 ,priority ,class #a1 ! ,adm9i/rator %all seek to balance consid]ations relat+ to-- 7aa7 ! numb] ( *emical sub/ances = :i* safety /&>d det]m9ations ne$ to be conduct$2 7bb7 ! res\rces available to ! ,adm9i/rator = conduct+ safety /&>d det]m9ations2 & 7cc7 ! deadl9es = completion ( safety /&>d det]m9ations specifi$ 9 subsection 7d77#d74 7ii7 ,priority ,class #b 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z ,priority ,class #b ^? *emical sub/ances t ! ,adm9i/rator det]m9es are ( l[] priority ?an ,priority ,class #a sub/ances ) respect to ! tim+ = conduct+ safety /&>d det]m9ations4 7,,ii7 ,m9imum in=mation set 7aa7 ,9 g5]al ,= *emical sub/ances designat$ "u ?is clause1 ! ,adm9i/rator %all require submission ( ! applicable m9imum in=mation set specifi$ "u section #d z ne$$ to in=m prioritization decisionmak+4 7bb7 ,tim+ ,! m9imum in=mation set %all be submitt$ to ! ,adm9i/rator-- 7,,aa7 n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac = *emical sub/ances 9 ! initial bat* id5tifi$ "u subsection 7a77#c7 t are assign$ to ,priority ,class #b2 & 7,,bb7 n lat] ?an #e ye>s aft] ! assignm5t ( a *emical sub/ance to ,priority ,class #b "u ?is clause = subsequ5t bat*es4 7,,iii7 ,reprioritization ,aft] submission ( ! m9imum in=mation set = a *emical sub/ance "u subclause 7,,ii71 ! ,adm9i/rator %all1 if w>rant$1 recategorize or o!rwise reprioritize ! *emical sub/ance us+ ! priority classes & process describ$ 9 ?is p>agraph1 toge!r ) o!r *emical sub/ances 9 ! bat* und]go+ prioritization at ! "t ( ! submission4 7,,iv7 ,reprioritization to ,priority ,class #a ,z safety /&>d det]m9ations are complet$ on ,priority ,class #a *emical sub/ances pursuant to subsection 7d71 ! ,adm9i/rator %all reprioritize ,priority ,class #b sub/ances z ,priority ,class #a at a pace consi/5t )-- 7aa7 ! res\rces available to ! ,adm9i/rator = conduct+ safety /&>d det]m9ations2 & 7bb7 ! deadl9es = completion ( safety /&>d det]m9ations specifi$ 9 subsection 7d77#d74 7iii7 ,priority ,class #c 7,i7 ,9 g5]al ,! ,adm9i/rator %all designate z ,priority ,class #c ^? *emical sub/ances t ! ,adm9i/rator det]m9es may be set aside = fur!r assessm5t until su* "t z-- 7aa7 safety /&>d det]m9ations are complet$ on all ,priority ,class #a & #b sub/ances2 or 7bb7 new in=mation arises t w>rants reprioritization ( su* a sub/ance to a high] priority class4 7,,ii7 ,m9imum in=mation set 7aa7 ,9 g5]al ,= a *emical sub/ance designat$ "u ?is clause1 ! ,adm9i/rator %all n require submission ( ! applicable m9imum in=mation set specifi$ "u section #d until su* "t z ! *emical sub/ance is reassign$ to ,priority ,class #a or #b4 7bb7 ,submission ,on reassignm5t ( a *emical sub/ance to ,priority ,class #a or #b "u item 7aa71 ! m9imum in=mation set %all be submitt$ to ! ,adm9i/rator n lat] ?an #e ye>s aft] ! date ( ! reassignm5t4 7,,iii7 ,reprioritization ,aft] submission ( ! m9imum in=mation set = a *emical sub/ance pursuant to subclause 7,,ii71 ! ,adm9i/rator %all reprioritize ! *emical sub/ance us+ ! priority classes & process describ$ 9 ?is p>agraph1 toge!r ) *emical sub/ances 9 ! bat* und]go+ prioritization at ! "t ( ! submission4 7,,iv7 ,reprioritization to ,priority ,classes #a & #b ,9 conjunction ) ! reprioritization by ! ,adm9i/rator ( ,priority ,class #b sub/ances z ,priority ,class #a1 ! ,adm9i/rator %all reprioritize ,priority ,class #c sub/ances z ,priority ,class #a or #b1 at a pace consi/5t )-- 7aa7 ! res\rces available to ! ,adm9i/rator = conduct+ safety /&>d det]m9ations2 & 7bb7 ! deadl9es = completion ( safety /&>d det]m9ations specifi$ 9 subsection 7d77#d74 7c7 ,treatm5t z f9al ag5cy action2 no judicial review2 nondiscretion>y duty 7#a7 ,9 g5]al ,! designation by ! ,adm9i/rator ( bat*es ( *emical sub/ances pursuant to subsection 7a71 ! assignm5t ( *emical sub/ances to categories pursuant to subsection 7b77#c71 & ! assignm5t ( *emical sub/ances to priority classes pursuant to subsection 7b77#d71 includ+ any det]m9ation ( ! ,adm9i/rator to include a specific *emical sub/ance 91 or exclude a specific *emical sub/ance f1 a designat$ bat*1 category1 or priority class "u ?is section1 %all n be-- 7,a7 consid]$ to be a f9al ag5cy action = ! purpose ( sub*apt] ,,ii ( *apt] #e1 & *apt] #g1 ( title #e1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,adm9i/rative ,proc$ure ,act72 or 7,b7 subject to judicial review4 7#b7 ,failure to act ,a failure by ! ,adm9i/rator to designate or publi% a li/ ( *emical sub/ances assign$ to a bat*1 category1 or priority class 9 accordance ) ?is subsection %all be-- 7,a7 consid]$ to be a failure to p]=m a nondiscretion>y duty2 & 7,b7 subject to judicial review4 7d7 ,safety /&>d det]m9ations = *emical sub/ances 7#a7 ,9 g5]al 7,a7 ,application ,?is p>agraph applies to any det]m9ation or r$et]m9ation reg>d+ :e!r a *emical sub/ance meets ! safety /&>ds ( ?is ,act4 7,b7 ,responsibilities 7i7 ,9 g5]al ,= purposes ( ?is ,act1 ea* manufactur] & processor ( a *emical sub/ance %all at all times be> ! burd5 ( pro( 9 any legal proce$+ relat+ to a decision ( ! ,adm9i/rator reg>d+ :e!r ! *emical sub/ance meets ! safety /&>d4 7ii7 ,duties ,= purposes ( ?is ,act-- 7,i7 x %all be ! duty ( ! manufactur] or processor ( a *emical sub/ance to provide suffici5t in=mation = ! ,adm9i/rator to det]m9e :e!r ! *emical sub/ance meets ! safety /&>d2 & 7,,ii7 x %all be ! duty ( ! ,adm9i/rator to det]m9e :e!r a *emical sub/ance meets ! safety /&>d4 7#b7 ,assessm5t ( risk 7,a7 ,assessm5t 7i7 ,9 g5]al ,a *emical sub/ance t und]goes a safety /&>d det]m9ation "u ?is section may be manufactur$1 process$1 or di/ribut$ 9 comm]ce only if ! ,adm9i/rator det]m9es t ! *emical sub/ance-- 7,i7 meets ! safety /&>d1 tak+ into acc\nt any exi/+ conditions or controls already 9 effect2 or 7,,ii7 c meet ! safety /&>d = all or "s uses ?r\gh ! imposition ( additional conditions4 7ii7 ,requirem5t ,any assessm5t ( risk us$ to support a det]m9ation t a *emical sub/ance meets ! safety /&>d "u clause 7i7 %all be conduct$ by employees ( ! ,environm5tal ,protection ,ag5cy :o are compet5t to conduct su* assessm5ts4 7,b7 ,safety /&>d 7i7 ,9 g5]al ,! ,adm9i/rator %all base a det]m9ation ( :e!r a safety /&>d = a *emical sub/ance has be5 met "u subp>agraph 7,a7 solely on consid]ations ( human heal? & ! environm5t1 includ+ ! heal? ( vuln]able populations4 7ii7 ,consid]ations ,9 mak+ a safety /&>d det]m9ation "u ?is subsection1 = ea* *emical sub/ance1 ! ,adm9i/rator %all-- 7,i7 to ! ext5t practicable1 review & incorporate any available sci5tific in=mation relat+ to ! effect ( cumulative exposure relevant to t *emical sub/ance on human heal? & ! environm5t2 & 7,,ii7 f9d t a *emical sub/ance meets ! safety /&>d only if ! ,adm9i/rator f9ds t !re is a reasonable c]ta9ty t no h>m w result to human heal? or ! environm5t f aggregate exposure to ! *emical sub/ance4 7,c7 ,f9ancial int]e/s ,no p]son conduct+ an assessm5t describ$ 9 subp>agraph 7,a71 or a pe] review ( su* an assessm5t1 may h a direct or indirect f9ancial int]e/ 9 ! outcome ( ! assessm5t4 7,d7 ,me?odology 7i7 ,9 g5]al ,subject to clause 7ii71 ! ,adm9i/rator %all use ! be/ available sci5ce :5 conduct+ an assessm5t describ$ 9 subp>agraph 7,a74 7ii7 ,consid]ations ,= ! purpose ( det]m9+ ! curr5t be/ available sci5ce ! ,adm9i/rator %all base ! det]m9ation on ! recomm5dations ( ! ,national ,academy ( ,sci5ces 9 ! report entitl$ ,sci5ce & ,decisions4 7iii7 ,review ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 & n less frequ5tly ?an once e #e ye>s !reaft]1 ! ,adm9i/rator %all review ! me?odology "u ?is p>agraph & may revise ! me?odology to reflect new sci5tific developm5ts or und]/&+s4 7,e7 ,scope ,an assessm5t describ$ 9 subp>agraph 7,a7 %all address heal? or environm5tal impacts includ+ pot5tial or demon/rat$ canc] & noncanc] endpo9ts4 7,f7 ,transp>5cy ,9 c>ry+ out ?is subsection1 ! ,adm9i/rator %all ensure t ! approa*es & result+ assessm5ts are communicat$ 9 a mann] t is transp>5t & und]/&able to-- 7i7 ! public2 & 7ii7 risk manag]s4 7,g7 ,manufacture or process+ = export ,9 ! case ( a *emical sub/ance t is manufactur$ or process$ 9 :ole or 9 "p = export1 9 det]m9+ :e!r ! *emical sub/ance meets ! safety /&>d "u subp>agraph 7,a77i71 ! ,adm9i/rator %all take into acc\nt any risk-- 7i7 t ! *emical sub/ance may pose 9 ! ,unit$ ,/ates1 includ+ risks involv+ long-range transport ( ! *emical sub/ance 9 ! environm5t2 or 7ii7 involv+ ! import ( articles & mixtures conta9+ ! *emical sub/ance4 7,h7 ,risk assessm5t n requir$ ,! ,adm9i/rator %all n be requir$ to conduct a risk assessm5t to det]m9e t a manufactur] or processor has n met ! burd5 ( pro( "u p>agraph 7#a77;,b74 7,i7 ,no judicial review ,a det]m9ation by ! ,adm9i/rator t a manufactur] or processor has n e/abli%$ t ! *emical sub/ance meets ! applicable safety /&>d "u ?is subsection %all n be subject to judicial review4 7#c7 ,in=mation = safety /&>d det]m9ations 7,a7 ,9 g5]al ,9 mak+ a safety /&>d det]m9ation ) respect to a *emical sub/ance1 ! ,adm9i/rator-- 7i7 %all take into consid]ation in=mation reg>d+ ! *emical sub/ance t is already available to ! ,adm9i/rator at ! "t ! det]m9ation is to be made1 includ+ in=mation-- 7,i7 receiv$ by ! ,adm9i/rator f manufactur]s or processors "u ?is section or section #h2 7,,ii7 conta9$ 9 any m9imum in=mation sets previ\sly requir$ "u section #d2 7,,iii7 volunt>ily submitt$ by manufactur]s & processors 9 accordance ) subsection 7b77#b77;,b72 7,,iv7 submitt$ by any o!r p>ty to ! ,adm9i/rator t is relevant to ! conduct ( a safety /&>d det]m9ation ( ! *emical sub/ance2 or 7,v7 id5tifi$ ?r\gh an active se>* by ! ,adm9i/rator ( in=mation s\rces t are publicly available or o!rwise accessible to ! ,adm9i/rator2 7ii7 %all require in=mation ne$$ to complete ! applicable m9imum in=mation set = ! *emical sub/ance requir$ "u section #d7;a72 7iii7 may require1 by regulation or ord] pursuant to section #d7;b7 or #h7;e71 manufactur]s or processors ( ! *emical sub/ance to develop & submit any additional in=mation ! ,adm9i/rator det]m9es is ne$$ to conduct ! safety /&>d det]m9ation ( ! *emical sub/ance2 & 7iv7 %all take into consid]ation1 b n rely on1 assessm5ts ( safety or analyses ( ! effectiv5ess ( exi/+ control measures-- 7,i7 submitt$ to ! ,adm9i/rator by any p>ty2 or 7,,ii7 conduct$ by a gov]nm5tal entity 9 ano!r jurisdiction4 7#d7 ,tim+ ( safety /&>d det]m9ations 7,a7 ,priority ,class #a 7i7 ,9 g5]al ,beg9n+ ) *emical sub/ances initially designat$ z ,priority ,class #a "u subsection 7b77#d77;,c77i71 ! ,adm9i/rator %all conduct safety /&>d det]m9ations ( all *emical sub/ances assign$ to ! category ( sub/ances to und]go safety /&>d det]m9ations pursuant to subsection 7b77#c77;,b77iii74 7ii7 ,initial bat* ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all complete & publi% safety /&>d det]m9ations = all *emical sub/ances designat$ z ,priority ,class #a sub/ances 9 ! initial bat* ( *emical sub/ances id5tifi$ "u subsection 7a77#c74 7iii7 ,subsequ5t bat*es ,n lat] ?an #e ye>s aft] ! date on :i* ! ,adm9i/rator designates *emical sub/ances z ,priority ,class #a 9 ea* subsequ5t bat* ( *emical sub/ances "u subsection 7a77#b77;,a71 ! ,adm9i/rator %all complete & publi% safety /&>d det]m9ations = ^? ,priority ,class #a sub/ances 9 ! bat*4 7,b7 ,priority ,classes #b & #c 7i7 ,9 g5]al ,ea* *emical sub/ance initially designat$ z ,priority ,class #b or #c %all become subject to reprioritization & safety /&>d det]m9ations 9 accordance ) subsection 7b77#d74 7ii7 ,reprioritization ,n lat] ?an #e ye>s aft] ! date on :i* ! ,adm9i/rator designates a ,priority ,class #b or #c sub/ance to be ,priority ,class #a1 ! ,adm9i/rator %all complete & publi% ! safety /&>d det]m9ation on ! *emical sub/ance4 7,c7 ,notice ( ov]due det]m9ation ,if ! ,adm9i/rator fails to act by an applicable deadl9e "u subp>agraph 7,a7 or 7,b71 ea* manufactur] & processor ( a *emical sub/ance = :i* ! ,adm9i/rator has fail$ to act %all provide to ! ,adm9i/rator1 ! public1 employees & recogniz$ b>ga9+ ag5ts ( any employees :o are repres5t$ by b>ga9+ ag5ts ( ! manufactur] or processor1 & ea* kn[n cu/om] :o has pur*as$ ! *emical sub/ance )9 a reasonable timeframe1 z det]m9$ by ! ,adm9i/rator by regulation or ord]1 a writt5 notice t a det]m9ation by ! ,adm9i/rator ( ! safety ( ! *emical sub/ance is p5d+4 7,d7 ,failure ( manufactur] or processor to meet duties ,if a manufactur] or processor fails to meet any duty "u ?is p>agraph = a *emical sub/ance1 ! ,adm9i/rator1 by ord]1 may take any action au?oriz$ "u subsection 7f74 7#e7 ,outcome ( safety /&>d det]m9ations 7,a7 ,det]m9ation 7i7 ,9 g5]al ,9 mak+ a safety /&>d det]m9ation = a *emical sub/ance1 ! ,adm9i/rator1 by ord]1 %all det]m9e or r$et]m9e1 z appropriate1 :e!r ! manufactur]s & processors ( ! *emical sub/ance h e/abli%$ t ! *emical sub/ance meets ! safety /&>d4 7ii7 ,concurr5t publication ,! ,adm9i/rator-- 7,i7 %all seek to publi% safety /&>d det]m9ation & risk managem5t decisions concurr5tly1 to ! maximum ext5t practicable2 b 7,,ii7 %all n unduly delay ! issuance ( any safety /&>d det]m9ation if m in=mation or analysis is requir$ to make a det]m9ation reg>d+ risk managem5t4 7iii7 ,o!r requirem5ts ,! ,adm9i/rator-- 7,i7 may publi% safety /&>d det]m9ations = *emical sub/ances individually or 9 gr\ps2 b 7,,ii7 %all publi% complet$ det]m9ations-- 7aa7 n less frequ5tly ?an annually2 & 7bb7 at a pace suffici5t to demon/rate /eady progress t[>d complet+ all su* safety /&>d det]m9ations )9 ! requir$ timeframe4 7iv7 ,public notice & comm5t ,! ,adm9i/rator %all provide reasonable public notice & opportunity = comm5t on all publi%$ safety /&>d det]m9ations ?r\gh any reasonable means ( publication & solicitation ( comm5ts1 includ+ electronic means4 7,b7 ,positive safety /&>d det]m9ation )\t new conditions ,if ! ,adm9i/rator det]m9es t a *emical sub/ance meets ! safety /&>d = all curr5t uses & "u conditions curr5tly us$1 ! ,adm9i/rator %all specify 9 ! ord]-- 7i7 ! all[$ uses ( ! *emical sub/ance1 :i* %all be limit$ to ! uses evaluat$ 9 ! det]m9ation2 & 7ii7 conditions on ! specifi$ uses t are curr5tly us$ & are to be foll[$ to ensure ! safety /&>d is met1 includ+ conditions relat+ to ! manufacture1 process+1 use1 di/ribution 9 comm]ce1 or disposal ( a *emical sub/ance or mixture or article conta9+ ! *emical sub/ance4 7,c7 ,positive safety /&>d det]m9ation ) new conditions ,if ! ,adm9i/rator det]m9es t a *emical sub/ance c only meet ! safety /&>d = a subset ( all curr5t uses or only "u conditions beyond ^? curr5tly us$1 ! ,adm9i/rator %all specify 9 ! ord]-- 7i7 ! all[$ uses ( ! *emical sub/ance1 :i* %all be limit$ to ! uses evaluat$ 9 ! det]m9ation t ! ,adm9i/rator det]m9es meet ! safety /&>d2 & 7ii7 all curr5t & all newly requir$ conditions on ! specifi$ uses ne$$ to ensure ! safety /&>d is met1 includ+ conditions relat+ to ! manufacture1 process+1 use1 di/ribution 9 comm]ce1 or disposal ( a *emical sub/ance or mixture or article conta9+ ! *emical sub/ance1 & any conditions describ$ 9 subsection 7f74 7,d7 ,effective date = positive safety /&>d det]m9ation 7i7 ,)\t new conditions ,effective beg9n+ on ! date t is #ij days aft] ! date ( a det]m9ation by ! ,adm9i/rator "u subp>agraph 7,b71 no p]son %all manufacture1 process1 or di/ribute 9 comm]ce ! *emical sub/ance subject to ! det]m9ation1 or any mixture or article conta9+ ! *emical sub/ance1 = any use or "u any condition o!r ?an ^? specifi$ 9 ! det]m9ation ord]4 7ii7 ,) new conditions ,effective beg9n+ on ! date t is #ah mon?s aft] ! date ( a det]m9ation by ! ,adm9i/rator "u subp>agraph 7,c71 except z provid$ 9 clause 7iii71 no p]son %all manufacture1 process1 or di/ribute 9 comm]ce ! *emical sub/ance subject to ! det]m9ation1 or any mixture or article conta9+ ! *emical sub/ance1 = any use or "u any condition o!r ?an ^? specifi$ 9 ! det]m9ation ord]4 7iii7 ,exceptional circum/ance ,! ,adm9i/rator may grant a manufactur] or processor ( a *emical sub/ance a #a-"t ext5sion ( ! deadl9e = comply+ ) a re/riction "u clause 7ii71 = a p]iod ( n long] ?an #e ye>s aft] ! date ( ! det]m9ation by ! ,adm9i/rator "u subp>agraph 7,c71 if ! manufactur] or processor demon/rates-- 7,i7 a compell+ te*nological ne$ to cont9ue a re/rict$ activity beyond ! applicable #ah-mon? "t p]iod2 or 7,,ii7 t a factor :olly beyond ! control ( ! manufactur] or processor prev5ts compliance ) ! re/riction )9 t #ah-mon? "t p]iod4 7,e7 ,r$et]m9ation 7i7 ,9 g5]al ,! ,adm9i/rator %all initiate a r$et]m9ation ( :e!r a *emical sub/ance meets ! safety /&>d if new in=mation or significant *anges 9 manufacture1 process+1 use1 or di/ribution 9 comm]ce ( ! *emical sub/ance1 or mixtures or articles conta9+ ! *emical sub/ance1 raise a cr$ible "q z to :e!r ! *emical sub/ance cont9ues to meet ! safety /&>d4 7ii7 ,new me?odologies ,! ,adm9i/rator may initiate a r$et]m9ation ( :e!r a *emical sub/ance meets ! safety /&>d if significant *anges h occurr$ 9 ! me?odologies us$ 9 ! initial safety /&>d det]m9ation su* t a r$et]m9ation us+ ! new] me?odologies w\ld provide a significantly improv$ det]m9ation ( ! safety ( ! *emical sub/ance4 7iii7 ,new in=mation ,= a *emical sub/ance = :i* a safety /&>d det]m9ation has be5 complet$1 ! ,adm9i/rator %all assess1 on an ongo+ basis1 new in=mation1 includ+ t obta9$ f report+ "u section #h1 to decide :e!r su* in=mation raises a cr$ible "q z to :e!r a *emical sub/ance cont9ues to meet ! safety /&>d4 7iv7 ,petition = r$et]m9ation 7,i7 ,9 g5]al ,any p]son may petition ! ,adm9i/rator = a r$et]m9ation ( :e!r a *emical sub/ance cont9ues to meet ! safety /&>d4 7,,ii7 ,basis ,a p]son %all include 9 a petition "u ?is clause a description ( ! basis = reque/+ ! r$et]m9ation4 7,,iii7 ,action by ,adm9i/rator ,on receipt ( a petition "u ?is clause1 ! ,adm9i/rator %all-- 7aa7 n lat] ?an #cj days aft] ! date ( receipt1 publi% 9 ! ,f$]al ,regi/] a notice ( receipt ( ! petition t specifies ! *emical id5tity ( ! *emical sub/ance to :i* ! petition p]ta9s2 7bb7 make ! petition available on reque/2 7cc7 provide a reasonable opportunity = public review & comm5t on ! petition & give due consid]ation to any comm5ts receiv$2 7dd7 decide :e!r to make ! reque/$ r$et]m9ation2 & 7ee7 n lat] ?an #ahj days aft] ! date ( receipt1 publi% 9 ! ,f$]al ,regi/] ! decision & ! basis = ! decision4 7v7 ,deadl9e = completion ,ea* r$et]m9ation c>ri$ out "u ?is subp>agraph %all be complet$ by n lat] ?an #c ye>s aft] ! date ( ! decision to make ! r$et]m9ation4 7,f7 ,negative safety /&>d det]m9ation 7i7 ,re/riction ,except z provid$ 9 clause 7ii7 & subsection 7h71 effective beg9n+ on ! date t is #ah mon?s aft] ! date on :i* ! ,adm9i/rator makes a det]m9ation "u ?is subsection t a *emical sub/ance fails to meet ! safety /&>d1 reg>dless ( :e!r additional re/rictions on use or risk managem5t conditions are impos$1 no p]son %all manufacture1 process1 or di/ribute 9 comm]ce t *emical sub/ance or any mixture or article conta9+ ! *emical sub/ance4 7ii7 ,exceptional circum/ance ,! ,adm9i/rator may grant a manufactur] or processor ( a *emical sub/ance a #a-"t ext5sion ( ! deadl9e = comply+ ) ! re/riction "u clause 7i71 = a p]iod ( n long] ?an #e ye>s aft] ! date ( ! det]m9ation by ! ,adm9i/rator "u ?is subp>agraph1 if ! manufactur] or processor demon/rates-- 7,i7 a compell+ te*nological ne$ to cont9ue a re/rict$ activity beyond ! applicable #ah-mon? "t p]iod2 or 7,,ii7 t a factor :olly beyond ! control ( ! manufactur] or processor prev5ts compliance ) ! re/riction )9 t #ah-mon? "t p]iod4 7e7 ,exp$it$ action = sub/ances ( v high conc]n 7#a7 ,use & exposure assessm5t 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date on :i* a *emical sub/ance is assign$ to ! category ( sub/ances ( v high conc]n "u subsection 7b77#c77;,b77i71 ! ,adm9i/rator may require1 by ord] pursuant to section #h7;g71 ! submission by manufactur]s or processors ( ! *emical sub/ance ( any additional in=mation ! ,adm9i/rator det]m9es to be necess>y to conduct an exp$it$ assessm5t ( ! kn[n uses (1 & exposures to1 ! *emical sub/ance4 7,b7 ,publication ,n lat] ?an #a ye> aft] ! date on :i* a *emical sub/ance is assign$ to ! category ( sub/ances ( v high conc]n "u subsection 7b77#c77;,b77i71 ! ,adm9i/rator %all complete & publi% an id5tification & assessm5t ( ! kn[n uses (1 & exposures to1 ! *emical sub/ance4 7#b7 ,exposure r$uction 7,a7 ,use re/rictions & o!r conditions ,z soon z practicable1 b n lat] ?an #ah mon?s1 aft] ! date on :i* a *emical sub/ance is assign$ to ! category ( sub/ances ( v high conc]n "u subsection 7b77#c77;,b77i71 ! ,adm9i/rator %all impose1 by ord]1 use re/rictions & o!r conditions1 includ+ ! conditions specifi$ 9 subsection 7f71 on ! manufactur+1 process+1 use1 di/ribution 9 comm]ce1 & disposal ( ! *emical sub/ance t ! ,adm9i/rator det]m9es to be necess>y to a*ieve ! maximum practicable r$uction 9 human or environm5tal exposure to ! *emical sub/ance4 7,b7 ,tim+ ,except z provid$ 9 subp>agraph 7,c7 & subsection 7h71 effective beg9n+ on ! date t is #ah mon?s aft] ! date ( issuance by ! ,adm9i/rator ( ! ord] describ$ 9 subp>agraph 7,a71 no p]son %all manufacture1 process1 or di/ribute 9 comm]ce ! *emical sub/ance subject to ! det]m9ation1 or any mixture or article conta9+ ! *emical sub/ance1 = any use or "u any condition o!r ?an ^? specifi$ 9 ! ord] issu$ "u subp>agraph 7,a74 7,c7 ,exceptional circum/ance ,! ,adm9i/rator may grant a manufactur] or processor ( a *emical sub/ance a #a-"t ext5sion ( ! deadl9e = comply+ ) ! re/riction "u subp>agraph 7,b71 = a p]iod ( n long] ?an #e ye>s aft] ! date ( ! det]m9ation by ! ,adm9i/rator "u ?is p>agraph1 if ! manufactur] or processor demon/rates-- 7i7 a compell+ te*nological ne$ to cont9ue a re/rict$ activity beyond ! applicable #ah-mon? "t p]iod2 or 7ii7 t a factor :olly beyond ! control ( ! manufactur] or processor prev5ts compliance ) ! re/riction )9 t #ah-mon? "t p]iod4 7#c7 ,residual risk assessm5t ,n lat] ?an #a ye> aft] ! deadl9e specifi$ 9 p>agraph 7#b77;,b71 or ( an alt]native deadl9e provid$ "u p>agraph 7#b77;,c71 ! ,adm9i/rator %all-- 7,a7 det]m9e :e!r ! *emical sub/ance meets ! safety /&>d = ! *emical sub/ance1 tak+ into acc\nt ! residual risk pos$ by cont9u$ exposure to ! *emical sub/ance2 & 7,b7 impose any additional re/rictions on use or o!r conditions "u subsection 7f7 t ! ,adm9i/rator det]m9es to be necess>y to ensure t ! *emical sub/ance meets ! safety /&>d4 7f7 ,risk managem5t ,9 issu+ an ord] "u subsection 7d7 or 7e71 ! ,adm9i/rator may impose conditions on ! manufacture1 process+1 use1 di/ribution 9 comm]ce1 or disposal ( a *emical sub/ance1 or mixture or article conta9+ a *emical sub/ance1 includ+ a requirem5t-- 7#a7 limit+ ! quantity ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce2 7#b7 7,a7 prohibit+ ! manufactur+1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 = a p>ticul> use 9 a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator2 or 7,b7 limit+ ! quantity ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 t may be manufactur$1 process$1 or di/ribut$ 9 comm]ce =-- 7i7 a p>ticul> use2 or 7ii7 a p>ticul> use 9 a conc5tration 9 excess ( a level specifi$ by ! ,adm9i/rator2 7#c7 t ! *emical sub/ance 7or mixture1 or article conta9+ t *emical sub/ance7 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 ( su* activities1 ) ! =m & cont5t ( ! w>n+s & in/ructions prescrib$ by ! ,adm9i/rator2 7#d7 t manufactur]s & processors ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7-- 7,a7 make & reta9 records ( ! processes us$ to manufacture or process ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance72 & 7,b7 monitor or conduct te/s t are reasonable & necess>y to ensure compliance ) ?is ,act2 7#e7 prohibit+ or o!rwise regulat+ any mann] or me?od ( comm]cial use ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance72 7#f7 prohibit+ or o!rwise regulat+ any mann] or me?od ( disposal ( ! *emical sub/ance1 mixture1 or article1 by-- 7,a7 ! manufactur] or processor ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance72 or 7,b7 any o!r p]son t uses or disposes ( ! *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 = comm]cial purposes2 7#g7 t ! manufactur]s & processors ( ! *emical sub/ance1 mixture1 or article develop a risk r$uction managem5t plan1 "u subsection 7h7 or 7e7 ( ?is section1 to a*ieve a risk r$uction specifi$ by ! ,adm9i/rator2 or 7#h7 t ! ,adm9i/rator o!rwise det]m9es is appropriate4 7g7 ,quality control ord]s 7#a7 ,9 g5]al ,if ! ,adm9i/rator has a reasonable basis to conclude t a p>ticul> manufactur] or processor is manufactur+ or process+ a *emical sub/ance 9 a mann] t may pres5t a sub/antial endang]m5t to heal? or ! environm5t1 ! ,adm9i/rator may require1 by ord]1 t ! manufactur] or processor submit to ! ,adm9i/rator a description ( ! quality control proc$ures foll[$ 9 ! manufactur+ or process+ ( ! *emical sub/ance or mixture4 7#b7 ,ord]s 7,a7 ,9 g5]al ,if ! ,adm9i/rator det]m9es t quality control proc$ures describ$ 9 p>agraph 7#a7 are inadequate to prev5t a *emical sub/ance f pres5t+ a risk ( injury to human heal? or ! environm5t1 ! ,adm9i/rator may ord] ! manufactur] or processor to revise ! quality control proc$ures to ! ext5t necess>y to rem$y ! inadequacy4 7,b7 ,sub/antial endang]m5t ,if ! ,adm9i/rator det]m9es t quality control proc$ures describ$ 9 p>agraph 7#a7 h result$ 9 ! di/ribution 9 comm]ce ( a *emical sub/ance t may pres5t a sub/antial endang]m5t to human heal? or ! environm5t1 ! ,adm9i/rator may ord] ! manufactur] or processor-- 7i7 to give notice ( ! endang]m5t to-- 7,i7 processors or di/ributors 7or bo?7 9 comm]ce ( ! *emical sub/ance or mixture2 & 7,,ii7 to ! ext5t reasonably asc]ta9able1 any o!r p]son 9 possession ( or expos$ to ! *emical sub/ance or mixture2 7ii7 to give public notice ( ! endang]m5t2 & 7iii7 to provide = ! replacem5t or repur*ase1 z prescrib$ by ! ,adm9i/rator1 ( ! *emical sub/ance z ! ,adm9i/rator det]m9es to be necess>y to adequately protect human heal? or ! environm5t4 7h7 ,exemptions to re/rictions 7#a7 ,application ,?is subsection applies to ! re/rictions e/abli%$ "u section #e7;b77#a77;,c77ii77,i71 subsection 7d77#e71 & subsections 7e7 & 7f74 7#b7 ,exemptions 7,a7 ,9 g5]al 7i7 ,reque/ ,a p]son :o manufactur]s1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( a *emical sub/ance1 or a mixture or article conta9+ a *emical sub/ance may reque/ an exemption f any re/riction ref]r$ to 9 p>agraph 7#a7 to :i* !y are subject = a specifi$ use ( ! *emical sub/ance4 7ii7 ,ord] ,! ,adm9i/rator may grant1 by ord]1 an exemption f any re/riction ref]r$ to 9 p>agraph 7#a7 = a p]iod ( n long] ?an #e ye>s if ! p]son has e/abli%$ by cle> & conv9c+ evid5ce t ! uses to be exempt$ meet ! exemption crit]ia describ$ 9 subp>agraph 7,b74 7,b7 ,crit]ia ,! ,adm9i/rator may grant an exemption = ! use ( a *emical sub/ance "u subp>agraph 7,a77ii7 if-- 7i7 ! exemption is 9 ! p>am\nt int]e/ ( national security2 7ii7 ! lack ( availability ( ! *emical sub/ance w\ld cause significant disruption 9 ! national economy2 or 7iii7 ! use = :i* ! exemption is s\ght is a critical or ess5tial use = :i*-- 7,i7 no feasible saf] alt]native = ! specifi$ use ( ! *emical sub/ance is available2 or 7,,ii7 ! specifi$ use ( ! *emical sub/ance1 z comp>$ to all available alt]natives1 provides a sub/antial net b5efit to human heal?1 ! environm5t1 or public safety4 7,c7 ,public notice ,if ! ,adm9i/rator grants an exemption = a *emical sub/ance "u ?is p>agraph-- 7i7 ! manufactur] or processor ( ! *emical sub/ance %all provide a notice ( ! exemption to ea* kn[n pur*as] (-- 7,i7 ! *emical sub/ance2 & 7,,ii7 a mixture or article conta9+ ! *emical sub/ance2 & 7ii7 ! ,adm9i/rator %all provide ! public ) a notice ( ! exemption4 7,d7 ,r5ewal ,! ,adm9i/rator may r5ew1 by ord]1 an exemption "u ?is p>agraph = #a or m additional #e-ye> p]iods if ! ,adm9i/rator concludes1 aft] provid+ public notice & an opportunity = comm5t1 t ! use ( ! *emical sub/ance cont9ues to meet ! crit]ia describ$ 9 subp>agraph 7,b74 7,e7 ,conditions 7i7 ,9 g5]al ,! ,adm9i/rator may impose1 by ord]1 any condition on an exemption issu$ "u ?is p>agraph t ! ,adm9i/rator det]m9es to be necess>y to ensure ! protection ( human heal? & ! environm5t on ! use ( a *emical sub/ance exempt$ "u ?is p>agraph4 7ii7 ,compliance ,effective imm$iately aft] ! ,adm9i/rator e/abli%es conditions on an exempt$ use "u clause 7i71 ! manufactur+1 process+1 or di/ribution 9 comm]ce ( ! *emical sub/ance1 or any mixture or article conta9+ ! *emical sub/ance1 %all be prohibit$ except to ! ext5t t ! conditions are satisfi$4 7#c7 ,sale ( us$ articles & lease ( exi/+ articles ,any re/riction ref]r$ to 9 p>agraph 7#a7 t w\ld o!rwise be applicable to ! sale or lease ( an article %all n apply to-- 7,a7 ! sale ( an article t 0 previ\sly pur*as$ by an end consum]2 or 7,b7 ! lease ( an article t 0 pur*as$ by ! lessor subsequ5t to ! manufacture ( ! article4 7#d7 ,ext5sions ( effective dates = retail sale ( articles to end consum]s 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 9 ! case ( ! retail sale to an end consum] ( a *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 t is subject to a re/riction describ$ 9 p>agraph 7#a71 ! ,adm9i/rator may ext5d1 by ord]1 ! effective date ( ! re/riction by a p]iod ( n long] ?an #c ye>s1 if ! ,adm9i/rator det]m9es t ! ext5sion-- 7i7 is necess>y & appropriate to all[ = depletion ( ! exi/+ retail inv5tory2 & 7ii7 w n pres5t a sub/antial endang]m5t to human heal? or ! environm5t4 7,b7 ,exception ,an ext5sion "u subp>agraph 7,a7 %all n apply to any retail] t ! ,adm9i/rator det]m9es has fail$ to comply ) an ord] reque/+ in=mation issu$ by ! ,adm9i/rator pursuant to section #h4 2 7#d7 9 subsection 7i7 7z r$esignat$ by p>agraph 7#b77-- 7,a7 by /rik+ p>agraph 7#d72 & 7,b7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#d72 & 7#e7 by ins]t+ aft] subsection 7i7 7z r$esignat$ by p>agraph 7#b77 ! foll[+3 7j7 ,m]cury 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 no ,f$]al ag5cy %all convey1 sell1 or di/ribute to any o!r ,f$]al ag5cy1 any ,/ate or local gov]nm5t ag5cy1 or any private individual or entity any elem5tal m]cury1 o!r ?an m]cury conta9$ )9 an article1 "u ! control or jurisdiction ( ! ,f$]al ag5cy4 7#b7 ,exceptions ,p>agraph 7#a7 %all n apply to-- 7,a7 a transf] betwe5 ,f$]al ag5cies ( elem5tal m]cury = ! sole purpose ( facilitat+ /orage ( m]cury to c>ry out ?is ,act2 or 7,b7 a conveyance1 sale1 di/ribution1 or transf] ( coal4 7#c7 ,leases ( ,f$]al coal ,no?+ 9 ?is subsection prohibits ! leas+ ( coal4 7k7 ,asbe/os 7#a7 ,exposure r$uction 7,a7 ,category ,n lat] ?an #ij days aft] ! enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all designate asbe/os z a *emical sub/ance ( v high conc]n "u subsection 7b77#c77;,b77i74 7,b7 ,use & exposure assessm5t ,n lat] ?an #ij days aft] ! date on :i* asbe/os is assign$ to ! category ( sub/ances ( v high conc]n "u subsection 7b77#c77;,b77i71 ! ,adm9i/rator %all complete & publi% an id5tification & assessm5t ( ! kn[n uses (1 & exposures to asbe/os4 7,c7 ,exposure r$uction ,z soon z practicable1 b n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all impose1 by ord]1 use re/rictions & o!r conditions1 includ+ ! conditions specifi$ 9 subsection 7f7 on ! manufactur+1 process+1 use1 di/ribution 9 comm]ce1 & disposal ( asbe/os t ! ,adm9i/rator det]m9es to be necess>y to a*ieve ! maximum practicable r$uction 9 human or environm5tal exposure to asbe/os4 ,! ,adm9i/rator %all select conditions t p]man5tly r$uce or elim9ate ! possibility ( exposures to ! maximum ext5t practicable4 7,d7 ,tim+ ( exposure r$uctions ,except z provid$ 9 clauses 7i7 & 7ii7 ( subsection 7h77#b77;,b71 effective beg9n+ on ! date t is #ab mon?s aft] ! date ( issuance by ! ,adm9i/rator ( ! ord] describ$ 9 subp>agraph 7,c71 no p]son %all manufacture1 process1 or di/ribute 9 comm]ce asbe/os subject to ! det]m9ation1 or any mixture or article conta9+ asbe/os1 = any use or "u any condition o!r ?an ^? specifi$ 9 ! ord] issu$ "u subp>agraph 7,c74 7#b7 ,managem5t ( mat]ial 7,a7 ,draft guidance ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,occupational ,safety & ,heal?1 %all publi% draft guidance describ+ ! /eps t ,f$]al ag5cies & contractors ( ,f$]al ag5cies %all take to enhance protections = public heal? & safety & ! environm5t1 & to bett] solicit in=mation f memb]s ( ! public :o may pot5tially be affect$ by asbe/os1 :5 ,f$]al ag5cies & contractors ( ,f$]al ,ag5cies h&le or dispose ( asbe/os4 ,! ,adm9i/rator %all all[ #cj days ( public comm5t on ?is draft guidance & hold no few] ?an two public meet+s on ?is draft guidance 9 communities impact$ by asbe/os contam9ation4 7,b7 ,f9al guidance ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,occupational ,safety & ,heal?1 %all publi% f9al guidance describ+ ! /eps t ,f$]al ag5cies & contractors ( ,f$]al ,ag5cies %all take to enhance protections = public heal? & safety & ! environm5t :5 h&l+ & dispos+ ( asbe/os4 ,! f9al guidance %all also include /eps t %all be tak5 to bett] solicit in=mation f & protect ! heal? & safety ( p locat$ ne> areas :]e asbe/os is locat$1 :]e asbe/os is transport$1 & :]e asbe/os disposal occurs4 7#c7 ,def9ition ,= purposes ( ?is section1 ! t]m asbe/os has ! mean+ giv5 su* t]m "u section #bjb7c74 7#d7 ,no effect on compliance ) environm5tal laws ,no?+ 9 p>agraph 7#b7 or any am5dm5t made by p>agraph 7#b7 %all be con/ru$ to affect or limit ! application ( or obligation to comply ) any environm5tal law1 includ+ ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act ( #aihj 7#db ,u4,s4,c4 #ifja et seq474 7l7 ,c]tification ,ea* submission requir$ "u ?is section 7or a regulation or ord] promulgat$ or issu$ by ! ,adm9i/rator pursuant to ?is section7 %all be accompani$ by a c]tification sign$ by a responsible (ficial ( ! manufactur] or processor t ea* /atem5t conta9$ 9 ! submission-- 7#a7 is accurate & reliable2 & 7#b7 includes all mat]ial facts requir$ by ! applicable provision ( ?is section or rule or ord] "u ?is section4 7m7 ,effective date ,9 any regulation or ord] "u ?is section1 ! ,adm9i/rator %all specify ! date on :i* ! regulation or ord] %all take effect1 :i* date %all be z soon z practicable aft] ! date ( promulgation or issuance ( ! regulation or ord]4 4 7b7 ,def9ition ( asbe/os ,section #bjb7c7 ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfdb7c77 is am5d$-- 7#a7 9 subp>agraph 7,e71 by /rik+ or2 7#b7 9 subp>agraph 7,f71 by /rik+ ! p]iod at ! end & ins]t+ 1 &2 & 7#c7 by add+ at ! end ! foll[+ 7,g7 any mat]ial =mally classifi$ z tremolite1 includ+-- 7i7 w9*ire asbe/os1 & 7ii7 ri*t]ite asbe/os1 & 7,h7 any asbe/i=m amphibole m9]al4 4 #h4 ,imm95t haz>ds ,section #g ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjf7 is am5d$ to read z foll[s3 #g4 ,imm95t haz>ds 7a7 ,actions au?oriz$ & requir$ 7#a7 ,9 g5]al ,! ,adm9i/rator may comm5ce a civil action 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates =-- 7,a7 seizure ( a *emical sub/ance or mixture1 or any article conta9+ a *emical sub/ance or mixture1 t may pres5t an imm95t & sub/antial endang]m5t to heal? or ! environm5t2 7,b7 relief au?oriz$ "u subsection 7b7 aga9/ any p]son t-- 7i7 manufactures1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( a *emical sub/ance or mixture1 or any article conta9+ a *emical sub/ance or mixture1 if ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal may pres5t an imm95t & sub/antial endang]m5t to heal? or ! environm5t2 or 7ii7 contributes to an activity describ$ 9 clause 7i72 or 7,c7 bo? seizure & relief describ$ 9 subp>agraphs 7,a7 & 7,b71 respectively4 7#b7 ,o!r actions 7,a7 ,9 g5]al ,! ,adm9i/rator may issue su* ord]s z are necess>y to protect heal? or ! environm5t f any manufactur+1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance or mixture1 or any article conta9+ su* a sub/ance or mixture1 t may pres5t an imm95t & sub/antial endang]m5t to heal? or ! environm5t1 z det]m9$ by ! ,adm9i/rator4 7,b7 ,requirem5t ,an ord] "u subp>agraph 7,a7 may include su* requirem5ts impos$ on ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance or mixture1 or article conta9+ ! *emical sub/ance or mixture1 z ! ,adm9i/rator det]m9es are necess>y to protect heal? or ! environm5t1 includ+-- 7i7 ! requirem5ts describ$ 9 section #f7;c72 & 7ii7 ! relief au?oriz$ "u subsection 7b74 7#c7 ,relation%ip to exi/+ rules1 ord]s1 & proce$+s ,a civil action may be comm5c$ "u p>agraph 7#a71 or o!r action may be tak5 "u p>agraph 7#b71 not)/&+-- 7,a7 ! exi/5ce ( a rule or ord] "u ?is ,act2 & 7,b7 ! p5d5cy ( any adm9i/rative or judicial proce$+ "u ?is ,act4 7b7 ,relief au?oriz$ 7#a7 ,9 g5]al ,! di/rict c\rt ( ! ,unit$ ,/ates 9 :i* a civil action "u subsection 7a77#a7 is br\ght %all h jurisdiction to grant su* tempor>y or p]man5t relief z are necess>y to protect heal? or ! environm5t f ! risk associat$ ) ! activity involv$ 9 ! civil action4 7#b7 ,types ( relief ,9 ! case ( a civil action "u subsection 7a77#a7 br\ght aga9/ a p]son t manufactures1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( a *emical sub/ance or mixture or an article conta9+ a *emical sub/ance or mixture1 ! relief au?oriz$ by p>agraph 7#a7 may include-- 7,a7 ! issuance ( a m&atory ord] impos+ any ( ! requirem5ts describ$ 9 section #f7;c72 & 7,b7 9 ! case ( pur*as]s ( ! sub/ance1 mixture1 or article kn[n to ! def5dant-- 7i7 notification to ! pur*as]s ( ! risk associat$ ) ! sub/ance1 mixture1 or article2 7ii7 public notice ( ! risk2 7iii7 recall2 7iv7 ! replacem5t or repur*ase ( ! sub/ance1 mixture1 or article2 or 7v7 any comb9ation ( ! actions describ$ 9 section #f7;c7 or 9 clauses 7i7 ?r\gh 7iv7 ( ?is subp>agraph2 or 7,c7 su* o!r relief z is necess>y to protect heal? or ! environm5t f ! risk associat$ ) ! activity involv$ 9 ! civil action4 7#c7 ,seizure & condemnation 7,a7 ,9 g5]al ,a civil action "u subsection 7a77#a7 aga9/ a *emical sub/ance1 mixture1 or article may be proce$$ aga9/ by process ( libel = seizure & condemnation ( ! *emical sub/ance1 mixture1 or article4 7,b7 ,proce$+s ,proce$+s 9 a civil action describ$ 9 subp>agraph 7,a7 %all con=m1 to ! maximum ext5t practicable1 to proce$+s 9 rem 9 admiralty4 7c7 ,v5ue & consolidation 7#a7 ,v5ue 7,a7 ,9 g5]al ,a civil action "u subsection 7a77#a7 aga9/ a p]son t manufactures1 processes1 or di/ributes a *emical sub/ance or mixture or an article conta9+ a *emical sub/ance or mixture may be br\ght 9 ! ,unit$ ,/ates ,di/rict ,c\rt = ! ,di/rict ( ,columbia1 or 9 any judicial di/rict 9 :i* any ( ! def5dants is f\nd1 resides1 or transacts bus9ess4 7,b7 ,process ,process 9 an action describ$ 9 subp>agraph 7,a7 may be s]v$ on a def5dant 9 any o!r di/rict 9 :i* ! def5dant resides or may be f\nd4 7,c7 ,*emical sub/ances1 mixtures1 or articles ,a civil action "u subsection 7a77#a7 aga9/ a *emical sub/ance1 mixture1 or article may be br\ght 9 any ,unit$ ,/ates di/rict c\rt )9 ! jurisdiction ( :i* ! *emical sub/ance1 mixture1 or article is f\nd4 7,d7 ,multiple judicial di/ricts ,9 det]m9+ ! judicial di/rict 9 :i* a civil action may be br\ght "u subsection 7a77#a7 9 in/ances 9 :i* ! action may be br\ght 9 m ?an #a judicial di/rict1 ! ,adm9i/rator %all take into acc\nt ! conv5i5ce ( ! p>ties4 7,e7 ,subpo5as ,subpo5as requir+ att5dance ( witnesses 9 a civil action br\ght "u subsection 7a77#a7 may be s]v$ 9 any judicial di/rict4 7#b7 ,consolidation ,if proce$+s "u subsection 7a77#a7 involv+ id5tical *emical sub/ances1 mixtures1 or articles are p5d+ 9 c\rts 9 #b or m judicial di/ricts1 ! proce$+s %all be consolidat$ = trial by ord] ( any su* c\rt on application reasonably made by any p>ty 9 int]e/1 on notice to all p>ties 9 int]e/4 4 #i4 ,report+ & ret5tion ( in=mation ,section #h ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjg7 is am5d$ to read z foll[s3 #h4 ,report+ & ret5tion ( in=mation 7a7 ,def9itions ,9 ?is section3 7#a7 ,kn[n to1 or reasonably asc]ta9able by ,! t]m kn[n to1 or reasonably asc]ta9able by has ! mean+ giv5 ! t]m 9 section #gjd4c ( title #dj1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,manufacture & process ,! t]ms manufacture & process mean manufacture & process1 respectively1 = comm]cial purposes4 7b7 ,decl>ations ( *emical sub/ances 9 comm]ce 7#a7 ,scope & crit]ia 7,a7 ,scope ,! decl>ations describ$ 9 ?is subsection %all apply only to *emical sub/ances 9 comm]ce z ( ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac4 7,b7 ,crit]ia ,! foll[+ crit]ia %all apply 9 id5tify+ *emical sub/ances to :i* ! decl>ations describ$ 9 ?is subsection apply3 7i7 ,curr5t comm]cial int]e/ ,a *emical sub/ance 9 :i* a manufactur] or processor has a curr5t comm]cial int]e/ %all include only *emical sub/ances t ! manufactur] or processor-- 7,i7 is curr5tly manufactur+ or process+2 or 7,,ii7 has manufactur$ or process$ 9 ! rec5t pa/ & expects to manufacture or process aga9 9 ! ne> future4 7ii7 ,pot5tial comm]cial int]e/ ,a *emical sub/ance 9 :i* a manufactur] or processor has a pot5tial comm]cial int]e/ %all include only a *emical sub/ance t may s]ve z a reasonable sub/itute = a *emical sub/ance 9 :i* ! manufactur] or processor has decl>$ a curr5t comm]cial int]e/4 7,c7 ,guidance ,n lat] ?an #ij days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all issue guidance fur!r describ+ ! crit]ia describ$ 9 subp>agraph 7,b7 & specify+ ! support+ in=mation manufactur]s & processors are to include 9 decl>ations !y submit pursuant to p>agraph 7#b7 or 7#c7 = *emical sub/ances 9 :i* !y h a curr5t or pot5tial comm]cial int]e/4 7#b7 ,decl>ation ( curr5t comm]cial int]e/ 9 a *emical sub/ance 7,a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ea* manufactur] ( a *emical sub/ance 9 :i* ! manufactur] has a curr5t comm]cial int]e/ %all submit to ! ,adm9i/rator a decl>ation ( ! int]e/ = ! *emical sub/ance4 7,b7 ,exclusions or exemptions ,decl>ations are requir$ = all *emical sub/ances 9 :i* a manufactur] has a curr5t comm]cial int]e/1 not)/&+ any exclusions or exemptions f o!r notification or report+ requirem5ts provid$ 9 any o!r provision ( ?is ,act4 7,c7 ,processors ,a processor ( a *emical sub/ance 9 :i* ! processor has a curr5t comm]cial int]e/ t meets ! crit]ia describ$ 9 p>agraph 7#a77;,b77i7 may volunt>ily submit to ! ,adm9i/rator a decl>ation = ! *emical sub/ance4 ,su* a decl>ation %all be submitt$ n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac4 7#c7 ,decl>ation ( pot5tial comm]cial int]e/ 9 a *emical sub/ance 7,a7 ,a manufactur] or processor may volunt>ily submit to ! ,adm9i/rator1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 a decl>ation = a *emical sub/ance 9 :i* ! manufactur] or processor-- 7i7 does n h a curr5t comm]cial int]e/2 b 7ii7 has a pot5tial comm]cial int]e/ t meets ! crit]ia describ$ 9 p>agraph 7#a77;,b77ii74 7,b7 ,if a manufactur] or processor comm5ces ! manufacture or process+ ( a *emical sub/ance = :i* x submitt$ a decl>ation "u ?is p>agraph1 ! manufactur] or processor %all comply ) ! requirem5ts ( subsection 7h77#e77;,b74 7#d7 ,decl>ation ( cessation ( manufactur+ or process+ ,a =m] or curr5t manufactur] or processor ( a *emical sub/ance 9 :i* ! manufactur] or processor no long] has a comm]cial int]e/ may volunt>ily submit to ! ,adm9i/rator1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 a decl>ation t ! manufactur] or processor has ceas$1 or w cease n lat] ?an #ahj days aft] ! date on :i* ! decl>ation is submitt$1 all production1 importation1 process+1 & export ( ! *emical sub/ance4 7#e7 ,cont5ts ,a decl>ation submitt$ "u ?is subsection %all include = ea* *emical sub/ance-- 7,a7 ! *emical id5tity & any special sub/ance *>act]i/ics ( ! *emical sub/ance2 7,b7 ! id5tity & prim>y bus9ess location ( ! manufactur] or processor2 & 7,c7 in=mation support+ ! decl>ant's basis = meet+ ! applicable crit]ia "u p>agraph 7#a77;,b74 7#f7 ,review by ,adm9i/rator 7,a7 ,9 g5]al ,! ,adm9i/rator %all-- 7i7 review ea* decl>ation receiv$ "u ?is subsection to det]m9e :e!r ! decl>ation con=ms to ! crit]ia & requirem5ts ( ?is subsection2 & 7ii7 7,i7 = a *emical sub/ance = :i* #a or m con=m+ decl>ations are submitt$ "u p>agraph 7#b71 add ! *emical sub/ance to ! li/ ( active *emical sub/ances 9 ! inv5tory e/abli%$ "u subsection 7h77#a72 7,,ii7 = a *emical sub/ance = :i* ! only con=m+ decl>ations submitt$ = ! sub/ance are submitt$ "u p>agraph 7#c71 add ! *emical sub/ance to ! li/ ( inactive *emical sub/ances 9 ! inv5tory e/abli%$ "u subsection 7h77#e72 & 7,,iii7 = a *emical sub/ance = :i* ! only con=m+ decl>ations submitt$ = ! sub/ance are submitt$ "u p>agraph 7#d71 or = :i* no decl>ation has be5 submitt$1 remove ! *emical sub/ance f ! inv5tories e/abli%$ "u subsection 7h74 7,b7 ,revisions ,! ,adm9i/rator %all all[ a manufactur] or processor1 z applicable1 to promptly revise & resubmit any decl>ation submitt$ to ! ,adm9i/rator "u ?is subsection if ! ,adm9i/rator det]m9es t any omission or error 9 ! orig9al decl>ation 0 n int5tional4 7c7 ,p]iodic report+ by manufactur]s 7#a7 ,9 g5]al ,! ,adm9i/rator %all-- 7,a7 ma9ta9 ! p]iodic report+ program ( ! ag5cy applicable to manufactur]s ( *emical sub/ances set =? 9 "p #gaa ( title #dj1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac71 unless su* report+ requirem5ts are sup]s$$ pursuant to subp>agraph 7,b72 or 7,b7 e/abli% a new p]iodic report+ program consi/5t ) ?is subsection4 7#b7 ,rulemak+ 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all specify1 by rule-- 7i7 ! *emical sub/ances = :i* p]iodic report+ is requir$2 & 7ii7 ! in=mation a *emical manufactur] is requir$ to submit to ! ,adm9i/rator = ! *emical sub/ances includ$ "u ! p]iodic report+ program4 7,b7 ,exemptions ,! rule promulgat$ "u subp>agraph 7,a7 may exempt c]ta9 manufactur]s1 includ+ small manufactur]s1 f-- 7i7 a requirem5t to p>ticipate 9 ! p]iodic report+ program1 if ! ,adm9i/rator det]m9es t ! p>ticipation ( ^? manufactur]s w\ld n assi/ 9 ! adm9i/ration ( ?is ,act2 or 7ii7 specific report+ requirem5ts1 if ! ,adm9i/rator det]m9es t ! value ( a p>ticul> report+ requirem5t1 = ! adm9i/ration ( ?is ,act1 w\ld n be comm5surate ) ! burd5 ( ! requirem5t on submitt]s4 7,c7 ,cont5ts ,! rule promulgat$ "u subp>agraph 7,a7 %all1 at a m9imum1 require ea* manufactur] ( a *emical sub/ance includ$ 9 ! p]iodic report+ program to submit to ! ,adm9i/rator-- 7i7 ! *emical id5tity & any special sub/ance *>act]i/ics ( ! *emical sub/ance1 ! id5tity & prim>y bus9ess location ( ! manufactur]1 & any updates to ! support+ in=mation submitt$ by ! manufactur] 9 any decl>ation = an includ$ *emical sub/ance submitt$ "u subsection 7b72 7ii7 a li/ ( heal? & safety /udies conduct$ or initiat$ by or =1 kn[n to1 or reasonably asc]ta9able by1 ! manufactur] ) respect to ea* includ$ *emical sub/ance2 7iii7 a copy ( ea* /udy describ$ 9 clause 7ii7 9 ! possession or control ( ! manufactur] t has n previ\sly be5 submitt$ to ! ,adm9i/rator2 & 7iv7 all o!r in=mation specifi$ by ! ,adm9i/rator 9 ! rules promulgat$ "u ?is subsection t is kn[n to1 9 ! possession or control (1 or reasonably asc]ta9able by1 ! manufactur] or processor t has n previ\sly be5 submitt$ to ! ,adm9i/rator reg>d+-- 7,i7 ! physical1 *emical1 & toxicological prop]ties ( ! *emical sub/ance2 7,,ii7 ! manufactur]'s annual production volume ( ! *emical sub/ance2 7,,iii7 ! uses (1 & exposure & fate in=mation relat+ to ! manufactur]'s production or import ( ! *emical sub/ance2 & 7,,iv7 ! "n & location ( ea* facility to :i* ! manufactur] s5ds ! *emical sub/ance aft] manufacture = subsequ5t process+1 di/ribution1 or use4 7d7 ,records ,to support decl>ations & p]iodic reports 7#a7 ,9 g5]al ,ea* manufactur] & processor ( a *emical sub/ance t is di/ribut$ 9 comm]ce %all-- 7,a7 ma9ta9 records ( ! in=mation submitt$ to ! ,adm9i/rator "u subsections 7b7 & 7c71 z well z support+ in=mation2 & 7,b7 submit ^? records or t in=mation to ! ,adm9i/rator ^u reque/ by ! ,adm9i/rator4 7#b7 ,burd5 ( pro( ,ea* manufactur] & processor t submits to ! ,adm9i/rator a decl>ation "u subsection 7b7 or a notice "u subsection 7h77#e77;,b7 %all at all times be> ! burd5 ( prov+ t ! manufactur] or processor-- 7,a7 has a curr5t or pot5tial comm]cial int]e/ 9 ! applicable *emical sub/ance2 or 7,b7 has ceas$ ! production1 importation1 process+1 & export (1 ! applicable *emical sub/ance4 7e7 ,sub/ance id5tification & in=mation = *emical processors 7#a7 ,rulemak+ 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all specify1 by rule1 ! in=mation t *emical processors are requir$ to submit = *emical sub/ances "u ?is subsection z w assi/ ! ,adm9i/rator 9 ! adm9i/ration ( ?is ,act4 7,b7 ,exemptions ,! rule promulgat$ "u ?is p>agraph may exempt c]ta9 processors1 includ+ small processors1 f-- 7i7 a requirem5t to p>ticipate 9 ! p]iodic report+ program1 if ! ,adm9i/rator det]m9es t ! p>ticipation ( ^? processors w\ld n assi/ 9 ! adm9i/ration ( ?is ,act2 or 7ii7 specific report+ requirem5ts1 if ! ,adm9i/rator det]m9es t ! value ( a p>ticul> report+ requirem5t1 = ! adm9i/ration ( ?is ,act1 w\ld n be comm5surate ) ! burd5 ( ! requirem5t on submitt]s4 7#b7 ,in=mation requirem5ts ,! rule promulgat$ "u p>agraph 7#a7 %all-- 7,a7 specify ! in=mation t processors are requir$ to submit = *emical sub/ances t are-- 7i7 process$ = use 9 #a or m consum] or comm]cial product categories1 z det]m9$ by ! ,adm9i/rator2 & 7ii7 int5tionally add$ to #a or m products dur+ process+ & n incid5tal to ! end uses ( ! products2 7,b7 require ea* processor ( a *emical sub/ance id5tifi$ "u subp>agraph 7,a7 to submit ! in=mation specifi$ 9 clauses 7i7 ?r\gh 7iii7 ( subp>agraph 7,c7 = ! *emical sub/ance1 & to submit ! in=mation specifi$ 9 clauses 7iv7 ?r\gh 7viii7 ( subp>agraph 7,c7-- 7i7 sep>ately = ea* applicable consum] & comm]cial product category2 & 7ii7 9 aggregate =m1 tak+ into acc\nt ! use by ! processor ( ! *emical sub/ance 9 all product categories2 7,c7 require ea* processor ( a *emical sub/ance id5tifi$ "u subp>agraph 7,a7 to id5tify 9 ! submission ( ! processor-- 7i7 ! corporate "n & prim>y bus9ess location ( ! processor2 7ii7 ! *emical id5tity & any special sub/ance *>act]i/ics ( ! *emical sub/ance2 7iii7 ! applicable consum] or comm]cial product category or categories = :i* ! processor processes ! *emical sub/ance2 7iv7 ! annual volume ( ! *emical sub/ance process$ by ! submitt]2 7v7 any products int5d$ = use by *ildr5 ag$ #ad ye>s or y\ng] = use 9 :i* ! processor processes ! *emical sub/ance2 7vi7 ! conc5tration range )9 :i* ! maximum conc5tration ( ! sub/ance us$ 9 ea* consum] & comm]cial product category falls2 7vii7 ! range )9 :i* ! total numb] ( comm]cial work]s reasonably likely to be expos$ to ! *emical sub/ance at ! process+ site falls2 & 7viii7 any o!r in=mation reg>d+ process+ activities or product descriptors relat+ to ! processor's process+ ( ! *emical sub/ance id5tifi$ by ! ,adm9i/rator z necess>y to und]/& ! pot5tial exposure f process$ *emical sub/ances or products 9 :i* ! *emical sub/ances are us$2 & 7,d7 require ea* processor to p]iodically report ! in=mation describ$ 9 subp>agraphs 7,b7 & 7,c7 = ! *emical sub/ances describ$ 9 subp>agraph 7,a74 7#c7 ,records ,! rules promulgat$ "u p>agraph 7#a7 %all require processors ( *emical sub/ances to :i* ^? rules apply-- 7,a7 to ma9ta9 records ( ! in=mation describ$ 9 p>agraph 7#b72 & 7,b7 to submit ^? records to ! ,adm9i/rator ^u reque/ by ! ,adm9i/rator4 7f7 ,updat+ ( in=mation 7#a7 ,9 g5]al ,ea* manufactur] or processor ( a *emical sub/ance t submits in=mation to ! ,adm9i/rator "u subsection 7c7 or 7e7 %all update ! in=mation-- 7,a7 at a m9imum e #d ye>s2 & 7,b7 at any "t t-- 7i7 ! manufactur] or processor obta9s k (1 comes into possession (1 or g5]ates significant new in=mation reg>d+ ! production1 process+1 use1 di/ribution1 haz>d1 or exposure pot5tial ( ! *emical sub/ance2 or 7ii7 !re is a significant *ange 9 ! production1 di/ribution 9 comm]ce1 or use ( ! *emical sub/ance by or kn[n to ! manufactur] or processor4 7#b7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all issue guidance on :at con/itutes significant new in=mation reg>d+ or significant *anges 9 ! production1 di/ribution 9 comm]ce1 or use ( a *emical sub/ance4 7g7 ,reports 7#a7 ,requirem5t 7,a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! ,adm9i/rator may by rule or ord] require any p]son :o manufactures1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( a *emical sub/ance1 or a mixture or article conta9+ ! *emical sub/ance to ma9ta9 records ( & report by a specifi$ date any exi/+ in=mation conc]n+ ! sub/ance t1 9 ! judgm5t ( ! ,adm9i/rator1 w\ld assi/ ! ,adm9i/rator 9-- 7i7 mak+ a safety /&>d det]m9ation ) respect to a *emical sub/ance2 7ii7 det]m9+ te/+ or in=mation ne$s = a *emical sub/ance2 7iii7 assign+ a *emical sub/ance to a bat*1 category1 or priority class pursuant to section #f2 7iv7 evaluat+1 develop+1 & implem5t+ risk managem5t conditions = a *emical sub/ance2 7v7 assess+ haz>ds1 exposures1 or risks relat$ to ! manufacture1 use1 di/ribution1 process+1 or disposal ( a *emical sub/ance2 7vi7 det]m9+ compliance ) any provision ( ?is ,act2 or 7vii7 any o!r aspect ( adm9i/]+ ?is ,act4 7,b7 ,*>act]i/ics ,! ,adm9i/rator may by rule or ord] require t any report or in=mation submitt$ pursuant to ?is ,act include *emical id5tity & special sub/ance *>act]i/ics1 z appropriate to ! *emical sub/ance t is ! subject ( ! report or in=mation4 7,c7 ,requir$ in=mation ,! ,adm9i/rator %all by rule or ord] specify or modify ! in=mation t is requir$ to be submitt$ ) a p>ticul> report or in=mation submission to e/abli% ! *emical id5tity & special sub/ance *>act]i/ics ( ! subject *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 = ! purposes ( ! report or in=mation submission4 7#b7 ,exemptions 7,a7 ,small quantities = rese>* or analysis ,9 ! case ( ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance 9 small quantities 7z def9$ by ! ,adm9i/rator by rule7 solely = purposes ( sci5tific exp]im5tation or analysis or *emical rese>* 7includ+ any su* rese>* or analysis = ! developm5t ( a product71 ! ,adm9i/rator may promulgate a rule or ord] "u p>agraph 7#a7 only to ! ext5t t ! ,adm9i/rator det]m9es t ! ma9t5ance ( records1 submission ( reports1 or bo?1 is necess>y = ! effective en=cem5t ( ?is ,act4 7,b7 ,small bus9ess ,! rules promulgat$ "u ?is subsection may exempt c]ta9 small bus9esses f ! rules promulgat$ "u ?is subsection1 if ! ,adm9i/rator det]m9es t ! p>ticipation ( ^? small bus9esses w\ld n assi/ 9 ! adm9i/ration ( ?is ,act4 7h7 ,inv5tories 7#a7 ,active inv5tory ,! ,adm9i/rator %all compile1 keep curr5t1 &1 subject to section #ad1 publi% a li/ ( ea* *emical sub/ance t is manufactur$ or process$ 9 ! ,unit$ ,/ates4 7#b7 ,cont5ts 7,a7 ,9 g5]al ,! li/ %all consi/ ( ^? *emical sub/ances = :i*-- 7i7 a notice is submitt$ "u section #e7;d71 consi/5t ) ! requirem5ts ( section #e7;b72 or 7ii7 a valid decl>ation is submitt$ "u p>agraph 7#b7 ( subsection 7b74 7,b7 ,exclusions ,! li/ %all n include-- 7i7 any *emical sub/ance = :i* ! only decl>ations submitt$ are submitt$ "u p>agraph 7#c7 or 7#d7 ( subsection 7b71 or = :i* no decl>ation has be5 submitt$2 or 7ii7 any *emical sub/ance = :i* an exemption has be5 grant$ "u section #e7;b77#a77;,c77ii7 or section #f7;h77#b74 7#c7 ,tim+ 7,a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b77;,b71 = a *emical sub/ance = :i* a notice is submitt$ "u section #e7;d71 ! *emical sub/ance %all be includ$ 9 ! li/ e/abli%$ "u p>agraph 7#a7 z ( ! e>lie/ date 7z det]m9$ by ! ,adm9i/rator7 on :i* ! sub/ance 0 manufactur$ or process$ 9 ! ,unit$ ,/ates4 7,b7 ,publication ,! ,adm9i/rator %all fir/ publi% a li/ "u p>agraph 7#a7 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac4 7#d7 ,small quantities = rese>* or analysis ,! ,adm9i/rator %all n include 9 ! li/ e/abli%$ "u p>agraph 7#a7 any *emical sub/ance t is manufactur$ or process$ only 9 small quantities 7z def9$ by ! ,adm9i/rator by rule7 solely = purposes ( sci5tific exp]im5tation or analysis or *emical rese>* on1 or analysis (1 ! sub/ance or ano!r sub/ance1 includ+ rese>* or analysis = ! developm5t ( a product4 7#e7 ,inactive inv5tory 7,a7 ,9 g5]al ,! ,adm9i/rator %all compile1 keep curr5t1 &1 subject to section #ad1 publi% an inactive li/ on :i* ! ,adm9i/rator %all include ea* *emical sub/ance = :i* ! only decl>ations submitt$ = ! sub/ance are submitt$ "u subsection 7b77#c74 7,b7 ,requirem5ts ,if a manufactur] or processor comm5ces ! manufacture or process+ ( a *emical sub/ance on ! inactive li/1 ! manufactur] or processor %all-- 7i7 n less ?an #cj days be=e recomm5c+ ! manufacture or process+ ( ! *emical sub/ance1 notify ! ,adm9i/rator2 & 7ii7 provide ) ! notification "u clause 7i7-- 7,i7 ! *emical id5tity & any special sub/ance *>act]i/ics ( ! *emical sub/ance2 7,,ii7 ! id5tity & prim>y bus9ess location ( ! manufactur]2 7,,iii7 a li/ ( heal? & safety /udies conduct$ or initiat$ by or =1 kn[n to1 or reasonably asc]ta9able by1 ! manufactur] or processor ) respect to ! *emical sub/ance2 7,,iv7 ^u reque/ ( ! ,adm9i/rator1 a copy ( ea* /udy describ$ 9 subclause 7,,iii7 9 ! possession or control ( ! manufactur] t has n previ\sly be5 submitt$ to ! ,adm9i/rator2 7,v7 ! project$ annual manufactur+ or process+ volume = ! *emical sub/ance = ea* ( ! subsequ5t #c ye>s2 7,,vi7 ! "n & location ( ea* facility to :i* ! *emical sub/ance is expect$ to be s5t1 aft] manufacture or process+1 = subsequ5t process+1 di/ribution 9 comm]ce1 or use2 & 7,,vii7 all o!r exi/+ in=mation kn[n to1 9 ! possession or control (1 or reasonably asc]ta9able by ! manufactur] or processor t has n previ\sly be5 submitt$ to ! ,adm9i/rator reg>d+-- 7aa7 ! toxicological prop]ties ( ! *emical sub/ance2 & 7bb7 ! uses (1 & exposure & fate in=mation relat+ to1 ! *emical sub/ance4 7,c7 ,adm9i/rator actions ,= any *emical sub/ance = :i* ! ,adm9i/rator receives a valid notification "u subp>agraph 7,b71 ! ,adm9i/rator %all promptly-- 7i7 move ! *emical sub/ance to ! active inv5tory e/abli%$ "u p>agraph 7#a72 & 7ii7 add ! *emical sub/ance to ! curr5t bat* ( *emical sub/ances id5tifi$ pursuant to section #f7;a71 & categorize ! *emical sub/ance ) o!r *emical sub/ances 9 ! bat*1 pursuant to section #f7;b74 7,d7 ,adm9i/ration ,disclosure ( any in=mation provid$ 9 ! notice describ$ 9 subp>agraph 7,b7 %all be subject to section #ad4 7#f7 ,*emicals n li/$ on or remov$ f ! inv5tories ,if a manufactur] or processor seeks to comm5ce ! manufacture or process+ ( a *emical sub/ance t is n li/$ on ! inv5tories e/abli%$ "u p>agraph 7#a7 or 7#e71 or t has be5 remov$ f ! inv5tories pursuant to subsection 7b77#f77;,a77ii77,,iii71 ! manufactur] or processor %all comply ) section #e4 7i7 ,public access to significant in=mation 7#a7 ,electronic database ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator1 ?r\gh collaboration z appropriate1 %all e/abli%-- 7,a7 an electronic1 ,int]net-accessible database = ! /or+ & %>+ ( in=mation relat+ to ! toxicity & use (1 & exposure to1 *emical sub/ances2 & 7,b7 proc$ures = use 9 ma9ta9+ & updat+ ! database4 7#b7 ,public access ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac or = decisions made or in=mation submitt$ aft] t #ah-mon? p]iod1 n lat] ?an #ij days aft] ! date on :i* a decision is made by ! ,adm9i/rator or in=mation submitt$ "u ?is title is receiv$ by ! ,adm9i/rator1 ! ,adm9i/rator %all1 subject to section #ad1 make available to ! public via ! ,int]net-accessible database describ$ 9 p>agraph 7#a7 a description ( all significant-- 7,a7 decisions made by ! ,adm9i/rator "u ?is title2 & 7,b7 in=mation submitt$ pursuant to ?is title4 7j7 ,records ( significant adv]se reactions 7#a7 ,9 g5]al ,any p]son t manufactures1 processes1 or di/ributes 9 comm]ce any *emical sub/ance %all ma9ta91 & on reque/ submit to ! ,adm9i/rator1 records ( significant adv]se reactions to human heal? or ! environm5t1 z det]m9$ by ! ,adm9i/rator by rule1 alleg$ to h be5 caus$ by ! sub/ance or mixture4 7#b7 ,duration 7,a7 ,9 g5]al ,records ( ! adv]se reactions to ! heal? ( employees %all be reta9$ = a p]iod ( #cj ye>s aft] ! date on :i* ! reactions 7 fir/ report$ to or kn[n by ! p]son ma9ta9+ ! records4 7,b7 ,o!r records ,any record ( o!r adv]se reactions %all be reta9$ = a p]iod ( #e ye>s aft] ! date on :i* in=mation conta9$ 9 ! record 0 fir/ report$ to or kn[n by ! p]son ma9ta9+ ! record4 7#c7 ,cont5ts ,records requir$ to be ma9ta9$ "u ?is subsection %all include-- 7,a7 records ( consum] allegations ( p]sonal injury or h>m to heal?2 7,b7 reports ( occupational disease or injury2 & 7,c7 reports or compla9ts ( injury to ! environm5t submitt$ to ! manufactur]1 processor1 or di/ributor 9 comm]ce f any s\rce4 7k7 ,in=mation 9 ! possession ( o!r f$]al ag5cies 7#a7 ,synopses 7,a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 f "t to "t1 ea* ,f$]al ag5cy & ,f$]al in/itution %all submit to ! ,adm9i/rator a synopsis ( ! data & records 9 ! possession or control ( ! ag5cy or in/itution1 respectively1 t may be useful to ! ,adm9i/rator 9 c>ry+ out ?is ,act4 7,b7 ,=mat & cont5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all prescribe1 by ord]1 ! =mat1 cont5t1 & level ( detail ( ! synopses4 7,c7 ,initial submission ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ea* ,f$]al ag5cy & ,f$]al in/itution %all make ! initial submission ( a synopsis ( ! ag5cy & in/itution1 respectively1 to ! ,adm9i/rator4 7,d7 ,updates ,at lea/ once e #c ye>s1 ea* ,f$]al ag5cy & ,f$]al in/itution %all-- 7i7 update ! synopsis ( ! ag5cy & in/itution1 respectively2 & 7ii7 submit ! updat$ synopsis to ! ,adm9i/rator4 7#b7 ,reque/s by ! adm9i/rator ,not)/&+ any o!r provision ( law1 on ! reque/ ( ! ,adm9i/rator1 any in=mation 9 ! possession or control ( an ag5cy or in/itution relat+ to a haz>d (1 use (1 exposure to1 or risk (1 a *emical sub/ance 7or mixture or article conta9+ t *emical sub/ance7 %all be submitt$ to ! ,adm9i/rator4 7l7 ,notice to adm9i/rator ( sub/antial risks ,any p]son t manufactures1 processes1 or di/ributes 9 comm]ce a *emical sub/ance & t obta9s in=mation t reasonably supports ! conclusion t ! sub/ance pres5ts a sub/antial risk ( injury to heal? or ! environm5t %all imm$iately in=m ! ,adm9i/rator ( ! in=mation unless ! p]son has actual k t ! ,adm9i/rator has be5 adequately in=m$ ( ! in=mation4 7m7 ,c]tification ,ea* submission requir$ pursuant to ?is section or pursuant to a rule or an ord] promulgat$ or issu$ by ! ,adm9i/rator "u ?is section1 o!r ?an a submission "u subsection 7k71 %all be accompani$ by a c]tification sign$ by a responsible (ficial ( ! manufactur]1 processor1 di/ributor1 us]1 or dispos] ( a *emical sub/ance t ea* /atem5t conta9$ 9 ! submission-- 7#a7 is accurate & reliable2 & 7#b7 includes all mat]ial facts requir$ by ! applicable provision ( ?is section or rule or ord] "u ?is section4 7n7 ,adm9i/ration 7#a7 ,9 g5]al ,no?+ 9 ?is section limits ! au?ority ( ! ,adm9i/rator to require report+ "u any o!r provision ( ?is ,act by any p]son :o manufactures1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( a *emical sub/ance1 or a mixture or article conta9+ a *emical sub/ance4 7#b7 ,violations ,9 addition to all o!r au?orities available = ! en=cem5t ( ?is ,act1 ! ,adm9i/rator may1 by ord]1 take any action au?oriz$ "u section #f7;f7 if a p]son :o manufactures1 processes1 di/ributes 9 comm]ce1 uses1 or disposes ( a *emical sub/ance1 or a mixture or article conta9+ a *emical sub/ance violates any provision ( ?is section4 4 #aj4 ,relation%ip to o!r ,f$]al laws ,section #i ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfjh7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ p>agraphs 7#a7 & 7#b7 & ins]t+ ! foll[+3 7#a7 ,report 7,a7 ,9 g5]al ,if ! ,adm9i/rator det]m9es t ! manufacture1 process+1 di/ribution 9 comm]ce1 use1 or disposal ( a *emical sub/ance1 or t any comb9ation ( ^? activities1 does n meet a safety /&>d "u ?is title or requires conditions or re/rictions 9 ord] to ! meet ! safety /&>d1 & ! ,adm9i/rator det]m9es t action may be tak5 "u a ,f$]al law n adm9i/]$ by ! ,adm9i/rator to address ! uses (1 or exposure to1 ! *emical sub/ance1 ! ,adm9i/rator %all submit to ! ag5cy t adm9i/]s ! ,f$]al law a report t-- 7i7 describes ) specification ! activity or comb9ation ( activities t prev5t ! *emical sub/ance f meet+ ! safety /&>d or re/rictions or conditions requir$ to meet ! safety /&>d "u ?is title2 7ii7 reque/s t ! ag5cy-- 7,i7 det]m9e :e!r ! #a or m actions may be tak5 "u ,f$]al law adm9i/]$ by ! ag5cy2 7,,ii7 if ! ag5cy det]m9es "u clause 7i7 t ! #a or m actions may be tak51 initiate & provide a timetable = ! #a or m actions2 & 7,,iii7 respond to ! ,adm9i/rator ) respect to ! matt]s describ$ 9 ! report2 & 7iii7 includes a detail$ /atem5t ( ! in=mation on :i* ! report is bas$4 7,b7 ,publication ,a report ( ! ,adm9i/rator submitt$ "u subp>agraph 7,a7 %all be promptly publi%$ 9 ! ,f$]al ,regi/]4 7,c7 ,action by recipi5t ag5cy ,n lat] ?an #ij days aft] ! date ( receipt ( a report f ! ,adm9i/rator "u subp>agraph 7,a71 or by su* e>li] date z ! ,adm9i/rator may specify 9 su* a report1 an ag5cy t receives ! report %all-- 7i7 make all det]m9ations reque/$ by ! ,adm9i/rator 9 ! report2 7ii7 take all action necess>y to ensure t a *emical sub/ance meets ! safety /&>d "u ?is title1 if appropriate2 7iii7 include ) ! response ( ! ag5cy a detail$ /atem5t ( ! f9d+s & conclusions ( ! ag5cy2 & 7iv7 publi% t /atem5t 9 ! ,f$]al ,regi/]4 7#b7 ,initiation ( action ,if ! ,adm9i/rator submits a report "u p>agraph 7#a7 ) respect to a *emical sub/ance to an ag5cy1 & ! ag5cy t receives ! report initiates1 )9 ! p]iod specifi$ 9 ! reque/ "u p>agraph 7#a71 a civil action "u ,f$]al law adm9i/]$ by ! ag5cy to ensure t a *emical sub/ance meets ! safety /&>d "u ?is title1 or requires re/rictions or conditions to meet t safety /&>d1 ! ,adm9i/rator may n take action "u ?is ,act ) respect to ! civil action 7o!r ?an any action tak5 pursuant to section #g74 2 7,b7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#d72 7,c7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,no action ,! ,adm9i/rator may1 by ord]1 initiate action or a comb9ation ( actions "u ?is ,act to ensure compliance ) ! safety /&>d = a *emical sub/ance "u ?is title if-- 7,a7 ! ,adm9i/rator submits a report "u p>agraph 7#a7 ) respect to a *emical sub/ance2 & 7,b7 ! ag5cy to :i* ! report 0 submitt$-- 7i7 det]m9es t action _c be tak5 "u ! au?orities ( ! ag5cy2 7ii7 does n initiate action1 if appropriate1 )9 ! p]iod specifi$ 9 ! reque/ "u p>agraph 7#a72 7iii7 does n complete ! action )9 ! timeframe provid$ by ! ag5cy2 or 7iv7 fails to respond4 2 & 7,d7 9 p>agraph 7#d7 7z r$esignat$ by subp>agraph 7,b77-- 7i7 by /rik+ 7#d7 ,if ! ,adm9i/rator has initiat$ action "u section #f or #g & ins]t+ ! foll[+3 7#d7 ,consultation ,if ! ,adm9i/rator has initiat$ action "u ?is ,act 2 & 7ii7 by /rik+ aga9/ su* risk aft] ,f$]al action2 7#b7 9 subsection 7c7-- 7,a7 by /rik+ ! ,adm9i/rator %all n & ins]t+ ,adm9i/rator-- 7#a7 %all n 2 & 7,b7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 %all ensure t any actions to address workplace exposures t ! ,adm9i/rator takes or requires to be tak5 by manufactur]s or processors ( a *emical sub/ance are consi/5t ) ! indu/rial hygi5e hi]>*y ( controls4 2 & 7#c7 9 subsection 7d7-- 7,a7 9 ! fir/ s5t5ce1 by /rik+ :ile impos+ ! lea/ burd5 ( duplicative requirem5ts on ^? subject to ! ,act & = o!r purposes2 & 7,b7 9 ! second s5t5ce1 by /rik+ 1 9 ! report requir$ by section #cj14 #aa4 ,inspections & subpo5as ,section #aa ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfaj7 is am5d$ to read z foll[s3 #aa4 ,inspections & subpo5as 7a7 ,inspections 7#a7 ,9 g5]al ,= purposes ( adm9i/]+ ?is ,act1 ! ,adm9i/rator1 & any duly designat$ repres5tative ( ! ,adm9i/rator1 may inspect-- 7,a7 any e/abli%m5t1 facility1 or o!r premises 9 :i* *emical sub/ances1 mixtures1 or articles subject to ?is ,act are manufactur$1 process$1 /or$1 or held be=e or aft] di/ribution 9 comm]ce2 7,b7 any conveyance be+ us$ to transport su* *emical sub/ances1 mixtures1 or articles 9 connection ) di/ribution 9 comm]ce2 & 7,c7 any place at :i* records relat+ to ! *emical sub/ances1 mixtures1 or articles1 or o!rwise relat+ to compliance ) ?is ,act1 are held4 7#b7 ,me?od ,ea* inspection "u p>agraph 7#a7 %all be-- 7,a7 comm5c$ & complet$ ) reasonable promptness2 & 7,b7 conduct$ at reasonable times1 )9 reasonable limits1 & 9 a reasonable mann]4 7#c7 ,samples ,! ,adm9i/rator1 & any duly designat$ repres5tative ( ! ,adm9i/rator1 may inspect & obta9 samples ( any-- 7,a7 *emical sub/ance1 mixture1 or article2 & 7,b7 conta9] or label+ ( a *emical sub/ance1 mixture1 or article4 7b7 ,scope ,an inspection conduct$ "u subsection 7a7 %all ext5d to all ?+s )9 ! premises or conveyance inspect$ 7includ+ records1 files1 pap]s1 processes1 controls1 & facilities7 reg>d+ :e!r ! own] or op]ator ( ! premises1 conveyance1 or records has compli$ ) provisions ( ?is ,act applicable to ! *emical sub/ances1 mixtures1 articles1 or records4 7c7 ,in=mation ga!r+ 7#a7 ,9 g5]al ,9 c>ry+ out ?is ,act1 ! ,adm9i/rator may require ! att5dance & te/imony ( witnesses & ! production ( su* reports1 pap]s1 docum5ts1 items1 answ]s to que/ions1 & o!r in=mation1 includ+ ! developm5t ( analyses & o!r in=mation1 z ! ,adm9i/rator det]m9es to be necess>y4 7#b7 ,paym5t ( witnesses ,a witness describ$ 9 p>agraph 7#a7 %all be paid ! same fees & mileage t are paid witnesses 9 ! c\rts ( ! ,unit$ ,/ates4 7d7 ,w>rants ,= purposes ( en=c+ ?is ,act1 ^u a %[+ to an (fic] or c\rt ( compet5t jurisdiction t !re is reason to believe t a provision ( ?is ,act has be5 violat$1 (fic]s or employees duly designat$ by ! ,adm9i/rator are emp[]$ to obta9 & to execute w>rants au?oriz+-- 7#a7 entry1 inspection1 & copy+ ( records = purposes ( ?is ,act2 & 7#b7 ! seizure ( any *emical sub/ance1 mixture1 or article t is 9 violation ( ?is ,act4 4 #ab4 ,exports ,section #ab ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfaa7 is am5d$-- 7#a7 by /rik+ subsection 7a72 7#b7 by r$esignat+ subsections 7b7 & 7c7 z subsections 7a7 & 7b71 respectively2 7#c7 9 subsection 7a7 7z r$esignat$ by p>agraph 7#b77-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ or int5ds to export2 7ii7 by /rik+ section #d or #e7;b7 & ins]t+ section #d1 #e1 or #f7;b72 7iii7 by /rik+ or int5t to export & ins]t+ 1 n lat] ?an #cj days aft] ! date ( exportation ( ! sub/ance or mixture12 & 7iv7 by ins]t+ promptly !reaft] be=e furni%2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ or int5ds to export2 7ii7 by /rik+ an ord] has be5 issu$ "u section #e or a rule has be5 propos$ or promulgat$ "u section #e or #f1 or ) respect to :i* an action is p5d+ or relief has be5 grant$ "u section #e or #g & ins]t+ an action has be5 tak5 pursuant to section #f or #g2 7iii7 by /rik+ or int5t to export & ins]t+ 1 n lat] ?an #cj days aft] ! date ( exportation ( ! sub/ance or mixture12 7iv7 by ins]t+ promptly !reaft] be=e furni%2 & 7v7 by /rik+ su* rule1 ord]1 action1 or relief & ins]t+ ! action tak5 pursuant to section #f or #g2 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,*ange 9 export /atus 7,a7 ,9 g5]al ,any p]son t has notifi$ ! ,adm9i/rator ( ! exportation ( a *emical sub/ance or mixture "u ?is section %all notify ! ,adm9i/rator ( any *ange 9 ! export /atus ( ! sub/ance or mixture by n lat] ?an #cj days aft] su* a *ange 9 /atus4 7,b7 ,updat$ notice ,! ,adm9i/rator %all promptly furni% an updat$ notice to ! gov]nm5ts t h be5 notifi$ pursuant to p>agraphs 7#a7 & 7#b7 reg>d+ ! exportation ( any *emical sub/ance or mixture subject to ?is section if-- 7i7 data = ! sub/ance or mixture h be5 receiv$ by ! ,adm9i/rator pursuant to section #d1 #e1 #f7;b71 or #h2 7ii7 a *ange has occurr$ 9 ! export /atus ( ! sub/ance or mixture2 or 7iii7 a *ange has be5 made 9 any risk managem5t action tak5 pursuant to section #f or #g = ! sub/ance or mixture4 2 7#d7 9 subsection 7b71 z r$esignat$ by p>agraph 7#b7 ( ?is section-- 7,a7 by /rik+ p>agraph 7#b72 & 7,b7 by r$esignat+ p>agraphs 7#c71 7#d71 7#e71 & 7#f7 z p>agraphs 7#b71 7#c71 7#d71 & 7#e71 respectively2 & 7#e7 by add+ at ! end ! foll[+3 7c7 ,public records ,! ,adm9i/rator %all-- 7#a7 ma9ta9 copies ( all curr5t notices provid$ to o!r gov]nm5ts "u ?is section2 & 7#b7 make su* copies available to ! public 9 electronic =mat4 4 #ac4 ,entry into cu/oms t]ritory ( ! ,unit$ ,/ates ,section #ac ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfab7 is am5d$-- 7#a7 by /rik+ ,secret>y ( ! ,treasury ea* place x appe>s & ins]t+ ,secret>y ( ,homel& ,security2 7#b7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by /rik+ if-- & subp>agraphs 7,a7 & 7,b7 & ins]t+ if ! sub/ance1 mixture1 or article fails to comply ) or is (f]$ = entry 9 violation ( any rule or ord] 9 effect "u ?is ,act42 & 7,b7 by add+ at ! end ! foll[+3 7#c7 ,import z "p ( an article ,*emical sub/ances & mixtures import$ z "p ( an article %all be subject to ! same requirem5ts "u ?is ,act z if ! sub/ances & mixtures _h be5 import$ 9 bulk1 except z ! ,adm9i/rator may provide by rule "u ?is ,act1 or z ! ,secret>y ( ,homel& ,security may provide by rule "u subsection 7b74 4 #ad4 ,disclosure ( data ,section #ad ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfac7 is am5d$ to read z foll[s3 #ad4 ,disclosure ( data 7a7 ,applicability 7#a7 ,9 g5]al ,subject to p>agraph 7#b7 & except z provid$ "u subsections 7b7 & 7e71 any in=mation report$ to1 or o!rwise obta9$ by1 ! ,adm9i/rator 7or any repres5tative ( ! ,adm9i/rator7 t is exempt f disclosure "u subsection 7a7 ( section #eeb ( title #e1 ,unit$ ,/ates ,code1 7commonly kn[n z ! ,fre$om ( ,in=mation ,act7 "u subsection 7b77#d7 ( t section1 %all n be disclos$ by ! ,adm9i/rator or by any (fic] or employee ( ! ,unit$ ,/ates1 unless ! designation ( ! in=mation z exempt f disclosure is prohibit$ "u ,f$]al law4 7#b7 ,exemptions 7,a7 ,m&atory exemptions ,not)/&+ any o!r provision ( law1 ! ,adm9i/rator %all disclose ! in=mation describ$ 9 p>agraph 7#a7-- 7i7 to any (fic] or employee ( ! ,unit$ ,/ates-- 7,i7 9 connection ) ! (ficial duties ( t (fic] or employee "u any law = ! protection ( human heal? or ! environm5t2 or 7,,ii7 = specific law en=cem5t purposes2 7ii7 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 ent]$ into on or aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac = ! p]=mance ( "w 9 connection ) ?is ,act & "u su* conditions z ! ,adm9i/rator may specify2 7iii7 if ! ,adm9i/rator det]m9es t ! disclosure is necess>y to protect human heal? or ! environm5t2 7iv7 on reque/1 to a ,/ate or tribal gov]nm5t = ! purpose ( developm5t or pot5tial developm5t1 adm9i/ration1 or en=cem5t ( a law1 if #a or m applicable agreem5ts 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 & 7v7 on reque/1 to public heal? or environm5tal heal? pr(essionals or m$ical p]sonnel if ! ,adm9i/rator det]m9es t-- 7,i7 disclosure is 9 ! public int]e/2 7,,ii7 ! recipi5t does n h a conflict ( int]e/ or competitive int]e/ ) respect to ! submitt] ( ! in=mation2 & 7,,iii7 #a or m applicable agreem5ts are 9 place to ensure t ! recipi5t ( ! in=mation provides comp>able protections to ^? provid$ by ! ,adm9i/rator to ma9ta9 ! confid5tiality ( ! in=mation4 7,b7 ,optional exemptions ,not)/&+ any o!r provision ( law1 ! ,adm9i/rator may disclose ! in=mation describ$ 9 p>agraph 7#a7 if relevant1 9 any proce$+ "u ?is ,act1 except t disclosure 9 su* a proce$+ %all be made 9 su* mann] z to pres]ve confid5tiality to ! maximum ext5t practicable )\t impair+ ! proce$+4 7#c7 ,effect on o!r laws ,9 any proce$+ "u section #eeb7;a7 ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act71 to obta9 in=mation1 ! disclosure ( :i* has be5 d5i$ pursuant to ?is section1 ! ,adm9i/rator may n rely on subsection 7b77#c7 ( t section to su/a9 ! action ( ! ,adm9i/rator4 7b7 ,categories ( confid5tial bus9ess in=mation 7#a7 ,in=mation t is always eligible = protection ,subject to subsection 7a77#b7 & any o!r applicable provision ( ,f$]al law1 ! ,adm9i/rator %all review & approve a reque/ t con=ms to ! requirem5ts describ$ 9 subsection 7c77#b7 to treat z confid5tial "u ?is section ! foll[+ in=mation3 7,a7 ,precise in=mation describ+ ! manufacture1 process+1 or di/ribution ( a *emical sub/ance or mixture4 7,b7 ,m>ket+ & sales in=mation4 7,c7 ,in=mation id5tify+ ! cu/om]s ( a manufactur]1 processor1 or di/ributor4 7,d7 ,details ( ! full composition ( a mixture ( a p>ticul> manufactur] or processor4 7,e7 ,precise in=mation ab\t ! use1 function1 or application ( a *emical sub/ance or mixture 9 a process1 mixture1 or product ( a p>ticul> manufactur] or processor4 7,f7 ,precise production or import volumes ( a p>ticul> manufactur]1 processor1 or di/ributor4 7#b7 ,in=mation t may be eligible = protection 7,a7 ,9 g5]al ,subject to subsection 7a7 & any o!r applicable provision ( ,f$]al law1 & except z provid$ 9 p>agraphs 7#a7 & 7#c71 in=mation submitt$ by a manufactur]1 processor1 or di/ributor to ! ,adm9i/rator may be protect$ if ! manufactur]1 processor1 or di/ributor complies ) subsection 7c77#b7 & ! ,adm9i/rator det]m9es t a reque/ to ma9ta9 ! confid5tiality ( ! in=mation meets ! applicable requirem5ts ( ?is subsection & any rule promulgat$ by ! ,adm9i/rator "u subsection 7c77#a74 7,b7 ,id5tities ( c]ta9 *emical sub/ances 7i7 ,9 g5]al ,not)/&+ subp>agraph 7,a71 ! ,adm9i/rator %all n disclose precise in=mation on ! id5tity ( a *emical sub/ance if-- 7,i7 ! manufactur] or processor ( ! sub/ance has1 9 accordance ) subsection 7c77#b7-- 7aa7 includ$ 9 a notice "u section #e7;b7 a reque/1 includ+ a ju/ification & docum5tation = ! reque/1 t ! id5tity ( ! sub/ance be treat$ z confid5tial bus9ess in=mation2 or 7bb7 submitt$ to ! ,adm9i/rator n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac a reque/1 includ+ a ju/ification & docum5tation = ! reque/1 t ! id5tity ( a sub/ance = :i* a notice has be5 submitt$ "u section #e7;b7 z ( ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac be treat$ z confid5tial bus9ess in=mation2 & 7,,ii7 ! ,adm9i/rator det]m9es t-- 7aa7 ! reque/ complies ) all applicable requirem5ts ( ?is section2 7bb7 ! *emical id5tity is n readily discov]able ?r\gh rev]se eng9e]+2 7cc7 ! manufactur] or processor takes reasonable measures to protect ! confid5tiality ( ! *emical sub/ance2 7dd7 no o!r ,f$]al /atute requires disclosure2 7ee7 disclosure ( ! id5tity ( ! *emical sub/ance w\ld cause f9ancial or competitive h>m to ! manufactur] or processor2 7ff7 ! *emical sub/ance is n1 bas$ on in=mation t is initially available or t lat] becomes available to ! ,adm9i/rator1 a kn[n or probable reproductive1 developm5tal1 neurological1 or immunological toxicant1 c>c9og51 or mutag52 7gg7 ! *emical sub/ance is n p]si/5t1 bioaccumulative1 & toxic2 & 7hh7 if a safety /&>d det]m9ation has be5 made = a *emical sub/ance1 ! ,adm9i/rator det]m9es t ! *emical sub/ance meets ! applicable safety /&>d ei!r "u curr5t conditions or "u additional conditions requir$ by ! ,adm9i/rator4 7ii7 ,notice ,9 cases :]e all ( ! requirem5ts specifi$ 9 clause 7i7 are met-- 7,i7 ! notice requir$ to be made public by ! ,adm9i/rator "u section #e7;f77#c7 %all include a ju/ification = ! det]m9ation ( ! ,adm9i/rator & id5tify ! *emical sub/ance by g5]ic class unless ! ,adm9i/rator det]m9es t m specific id5tification is requir$ 9 ! public int]e/2 & 7,,ii7 z "p ( a claim to protect ! id5tity ( a *emical sub/ance "u subsection 7c77#b71 a manufactur] or processor may provide a public "n = ! *emical sub/ance = use by ! ,adm9i/rator :5 %>+ in=mation on ! *emical sub/ance "u ?is subsection4 ,! public names %\ld disclose a maximum am\nt ( in=mation on ! *emical /ructure ( ! sub/ance1 :ile protect+ ^? features ( ! *emical /ructure t are consid]$ confid5tial & ! disclosure ( :i* w\ld pot5tially h>m ! own] ( t in=mation4 7iii7 ,duration ( protection = *emical id5tity ,not)/&+ subsection 7c77#a77;,b77iv71 ! id5tity ( a *emical sub/ance = :i* a reque/ has be5 submitt$ pursuant to clause 7i77,i7 & meets ! requirem5ts ( clause 7i7 %all be protect$ z confid5tial bus9ess in=mation-- 7,i7 = su* p]iod ( "t z ! ,adm9i/rator1 aft] review+ ! reque/1 det]m9es to be reasonable2 & 7,,ii7 ^u expiration ( a "t p]iod specifi$ "u ?is clause1 = an additional #e-ye> p]iod1 if ! ,adm9i/rator1 aft] review+ ! reque/1 det]m9es t ! reque/ = protection cont9ues to meet ! crit]ia e/abli%$ 9 ?is subp>agraph4 7iv7 ,publication requirem5t ,! ,adm9i/rator %all annually publi% a notice t-- 7,i7 includes an updat$1 cumulative li/ ( ea* new *emical sub/ance = :i* ! ,adm9i/rator has approv$ a reque/ to protect in=mation "u ?is p>agraph1 id5tifi$ by a unique id5tifi]1 o!r ?an ! precise *emical id5tity1 & includ+ ! p]iod ( "t = :i* ! protection applies2 & 7,,ii7 = ea* *emical sub/ance = :i* ! protection provid$ "u ?is p>agraph has expir$1 provides ! precise id5tity ( ! *emical sub/ance1 & provides public access to any in=mation t _h be5 submitt$ to ! ,adm9i/rator :i* conceal$ ! id5tity ( ! *emical sub/ance 9 accordance ) ?is p>agraph4 7,c7 ,impurities ,not)/&+ subp>agraph 7,a71 ! ,adm9i/rator may det]m9e n to disclose in=mation relat+ to ! degree ( purity or ! id5tity ( impurities pres5t 9 a *emical sub/ance or mixture if ! ,adm9i/rator det]m9es t k ( ! in=mation w\ld reveal processes us$ 9 ! manufactur+ or process+ ( ! *emical sub/ance or mixture4 7#c7 ,in=mation t is nev] eligible = protection 7,a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! ,adm9i/rator %all disclose ! foll[+ in=mation3 7i7 ,! id5tity ( a *emical sub/ance4 7ii7 ,any safety /&>d det]m9ation develop$ "u section #f1 includ+ support+ analysis develop$ by ! ,adm9i/rator4 7iii7 ,any heal? & safety /udy data t is submitt$ "u ?is ,act ) respect to-- 7,i7 any *emical sub/ance or mixture-- 7aa7 t has be5 (f]$ = comm]cial di/ribution z ( ! date on :i* ! /udy is to be disclos$2 or 7bb7 = :i* te/+ is requir$ "u section #d or = :i* notification is requir$ "u section #e2 & 7,,ii7 any data report$ to1 or o!rwise obta9$ by1 ! ,adm9i/rator f a heal? & safety /udy t relates to a *emical sub/ance or mixture describ$ 9 subclause 7,i74 7iv7 ,heal? & safety data 9 notices ( sub/antial risk submitt$ pursuant to section #h7l7 & 9 ! und]ly+ /udies4 7v7 ,g5]al in=mation describ+ ! manufactur+ volumes1 express$ 9 ranges1 & indu/rial1 comm]cial1 or consum] functions & uses ( a *emical sub/ance or mixture4 7vi7 ,any in=mation indicat+ ! pres5ce ( a *emical sub/ance 9 consum] products int5d$ = use1 or reasonably expect$ to be us$1 by *ildr5 ag$ #ad ye>s or y\ng]1 if-- 7,i7 ! ,adm9i/rator1 or ano!r au?oritative body1 has det]m9$ t ! *emical sub/ance-- 7aa7 is a kn[n or probable reproductive1 developm5tal1 neurological1 or immunological toxicant1 c>c9og51 or mutag52 or 7bb7 is p]si/5t1 bioaccumulative1 & toxic2 or 7,,ii7 = a *emical sub/ance = :i* a safety /&>d det]m9ation has be5 made1 ! ,adm9i/rator has n f\nd t ! *emical sub/ance meets ! safety /&>d4 7,b7 ,prohibition ,no?+ 9 ?is p>agraph au?orizes ! release ( any data t discloses a process us$ 9 ! manufactur+ or process+ ( a *emical sub/ance or mixture1 or 9 ! case ( a mixture1 ! release ( data disclos+ ! portion ( ! mixture compris$ by any ( ! *emical sub/ances 9 ! mixture4 7,c7 ,applicability ( o!r laws ,except z provid$ 9 p>agraph 7#b71 if ! ,adm9i/rator receives a reque/ = in=mation "u section #eeb7;a7 ( title #e1 ,unit$ ,/ates ,code1 7commonly kn[n z ! ,fre$om ( ,in=mation ,act7 = in=mation describ$ 9 subp>agraph 7,a71 :i* is n in=mation describ$ 9 subp>agraph 7,b71 ! ,adm9i/rator %all n d5y ! reque/ "u subsection 7b77#d7 ( t section4 7c7 ,designation & treatm5t ( confid5tial bus9ess in=mation 7#a7 ,duties ( ! adm9i/rator 7,a7 ,rules ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all promulgate rules t specify-- 7i7 ! acceptable bases on :i* writt5 reque/s to ma9ta9 confid5tiality ( in=mation may be approv$1 :i* %all be consi/5t ) ! requirem5ts ( ?is section2 7ii7 ! nature ( ! docum5tation & ju/ification t mu/ accompany su* a reque/2 & 7iii7 ! types ( in=mation ! ,adm9i/rator det]m9es w>rant protection = an indef9ite p]iod ( "t1 = :i* ! t]m ( confid5tiality specifi$ 9 subp>agraph 7,b77iv77,i7 %all n apply4 7,b7 ,review ( reque/s 7i7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( receipt ( in=mation "u p>agraph 7#b71 ! ,adm9i/rator %all review a reque/ to ma9ta9 confid5tiality ( in=mation submitt$ "u ?is ,act & det]m9e :e!r to approve1 modify1 or d5y t reque/ bas$ on ! regulations promulgat$ by ! ,adm9i/rator "u subp>agraph 7,a74 7ii7 ,process ,! ,adm9i/rator %all1 9 accordance ) clause 7i7-- 7,i7 review all reque/s receiv$ to ma9ta9 confid5tiality ( submitt$ in=mation2 or 7,,ii7 if x is n feasible = ! ,adm9i/rator to review all ( ! reque/s-- 7aa7 review all reque/s relat+ to in=mation describ$ 9 subsection 7b77#b77;,b72 & 7bb7 review a repres5tative subset t includes n less ?an #be p]c5t ( all o!r reque/s receiv$2 & 7,,iii7 publi% 9 ! ,f$]al ,regi/] on at lea/ an annual basis a description ( ! numb] & types ( reque/s receiv$ & review$ by ! ,adm9i/rator4 7iii7 ,d5ials ,if a reque/ to ma9ta9 confid5tiality ( submitt$ in=mation is d5i$ 9 accordance ) subp>agraph 7,d71 ! ,adm9i/rator %all promptly make ! in=mation available to ! public 9 accordance ) section #h7;i77#b74 7iv7 ,approvals ,if a reque/ to ma9ta9 confid5tiality ( submitt$ in=mation is approv$1 ! ,adm9i/rator %all-- 7,i7 except ) respect to reque/s subject to a rule issu$ pursuant to subp>agraph 7,a77iii7 & reque/s submitt$ pursuant to subsection 7b77#b77;,b77i77,i71 specify a "t p]iod n to exce$ #e ye>s = :i* ! submitt$ in=mation %all be kept confid5tial1 unless ! in=mation o!rwise becomes available to ! public dur+ ! p]iod2 & 7,,ii7 ^u ! expiration ( ! protection p]iod1 make ! in=mation available to ! public unless ! manufactur]1 processor1 or di/ributor has submitt$1 docum5t$1 & ju/ifi$ to ! satisfaction ( ! ,adm9i/rator & 9 accordance ) ?is subsection ! basis = a r5ewal ( ! protection1 = a "t p]iod n to exce$ #e ye>s4 7,c7 ,au?ority ( ! adm9i/rator ,no?+ 9 subp>agraph 7,a7 or 7,b7 limits ! au?ority ( ! ,adm9i/rator to det]m9e t p>ticul> in=mation1 previ\sly treat$ z confid5tial1 is no long] entitl$ to confid5tial treatm5t4 7,d7 ,notifications 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 if ! ,adm9i/rator proposes to release in=mation = :i* a reque/ = confid5tial treatm5t has be5 approv$ "u ?is section1 ! ,adm9i/rator %all electronically notify ! manufactur]1 processor1 or di/ributor 9 comm]ce :o submitt$ ! reque/ ( ! int5t ( ! ,adm9i/rator to release ! in=mation n less ?an #ae days prior to ! release ( ! in=mation4 7ii7 ,adm9i/ration ,! ,adm9i/rator %all release ! in=mation describ$ 9 clause 7i7 9 accordance ) ! disclosure & proc$ural requirem5ts ( section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly kn[n z ! #8,fre$om ( ,in=mation ,act'71 except t-- 7,i7 if ! release ( ! in=mation is to be made pursuant to a reque/ made "u section #eeb7;a7 ( title #e1 ,unit$ ,/ates ,code1 ! notice %all be giv5 imm$iately ^u approval ( ! reque/ by ! ,adm9i/rator2 7,,ii7 if ! ,adm9i/rator det]m9es t ! release ( in=mation pursuant to subsection 7a77#b77;,a77iii7 is necess>y to protect aga9/ imm95t & sub/antial h>m to human heal? or ! environm5t1 no notice %all be requir$2 & 7,,iii7 ! requirem5ts ( ?is subp>agraph %all n apply to ! release ( in=mation "u-- 7aa7 clauses 7i7 ?r\gh 7iii7 ( subsection 7a77#b77;,a72 or 7bb7 subsection 7b77#c77;,a74 7#b7 ,duties ( manufactur]s1 processors1 & di/ributors 7,a7 ,9 g5]al ,9 submitt+ data "u ?is ,act1 a manufactur]1 processor1 or di/ributor 9 comm]ce may-- 7i7 designate in=mation1 o!r ?an in=mation describ$ 9 subsection 7b77#c71 = :i* ! manufactur]1 processor1 or di/ributor reque/s confid5tial treatm5t "u subsection 7a7 or 7b72 & 7ii7 submit ! designat$ data sep>ately f o!r data submitt$ "u ?is ,act4 7,b7 ,requirem5ts ,a designation "u ?is p>agraph %all be made 9 writ+ & 9 su* mann] z ! ,adm9i/rator may prescribe1 & %all include-- 7i7 docum5tation & ju/ification = ea* reque/ = confid5tiality1 except = reque/s relat+ to ! in=mation describ$ 9 subsection 7b77#a72 7ii7 ! p]iod ( "t = :i* ma9t5ance ( confid5tiality ( ! in=mation is reque/$ except ) respect to reque/s subject to a rule issu$ pursuant to subsection 7c77#a77;,a77iii72 7iii7 a c]tification t ! in=mation is n o!rwise publicly available2 7iv7 sep>ate copies ( all submitt$ in=mation1 ) #a copy conta9+ & #a copy exclud+ ! in=mation to :i* ! reque/ applies2 & 7v7 any additional in=mation requir$ by ! ,adm9i/rator4 7,c7 ,reque/ = r5ewal ,prior to ! expiration ( ! specifi$ "t p]iod det]m9$ by ! ,adm9i/rator "u p>agraph 7#a77;,b77iv71 a manufactur]1 processor1 or di/ributor may submit a reque/ = r5ewal ( protection = protect$ in=mation4 ,?is reque/ = r5ewal %all foll[ ! same proc$ures & requirem5ts z ! initial submission "u subp>agraphs 7,a7 & 7,b74 7d7 ,civil p5alty = wrongful disclosure or wrongful reque/s = protection 7#a7 ,9 g5]al ,any (fic] or employee ( ! ,unit$ ,/ates or =m] (fic] or employee ( ! ,unit$ ,/ates1 :o1 by virtue ( employm5t or (ficial position has obta9$ possession (1 or has access to1 mat]ial ! disclosure ( :i* is prohibit$ by subsection 7a71 & :o kn[+ t disclosure ( ! mat]ial is prohibit$ by t subsection1 willfully discloses ! mat]ial 9 any mann] to any p]son n entitl$ to receive ! in=mation1 %all be subject to appropriate discipl9>y action & subject to a civil money p5alty ( n m ?an #aj1jjj = ea* violation4 7#b7 ,applicability ( o!r laws ,section #aije ( title #ah1 ,unit$ ,/ates ,code1 %all n apply ) respect to ! publi%+1 divulg+1 disclosure1 mak+ kn[n1 or mak+ available (1 in=mation report$ or o!rwise obta9$ "u ?is ,act4 7#c7 ,contractors ,= ! purposes ( p>agraph 7#a71 any contractor ) ! ,unit$ ,/ates :o is furni%$ in=mation z au?oriz$ by subsection 7a77#b71 includ+ any employee ( su* a contractor1 %all be consid]$ to be an employee ( ! ,unit$ ,/ates4 7#d7 ,false reque/s ,any (fic] or employee ( a company t submits in=mation "u ?is ,act :o willfully designates in=mation z eligible = confid5tial treatm5t1 kn[+ t ! in=mation is ineligible = su* treatm5t1 %all be subject to a civil money p5alty ( n m ?an #aj1jjj = ea* su* violation4 7e7 ,access by congress ,not)/&+ ?is section or any o!r provision ( law1 all in=mation report$ to or o!rwise obta9$ by ! ,adm9i/rator 7or any repres5tative ( ! ,adm9i/rator7 "u ?is ,act %all be made available1 on writt5 reque/ ( any duly au?oriz$ committee ( ,congress1 to t committee4 7f7 ,risk in=mation = work]s ,! ,adm9i/rator %all facilitate ! %>+ ( in=mation t p]ta9s to *emical sub/ances or mixtures or articles conta9+ *emical sub/ances t work]s may come into contact ) or may o!rwise be expos$ to dur+ ! c\rse ( "w ) ^? work]s & repres5tatives ( ea* c]tifi$ or recogniz$ b>ga9+ ag5t repres5t+ ^? work]s4 ,no?+ 9 ?is subsection au?orizes disclosure ( in=mation o!r ?an ^? disclosures t may be made pursuant to subsections 7a7 ?r\gh 7e74 4 #ae4 ,prohibit$ acts ,section #ae ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfad7 is am5d$-- 7#a7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 fail or refuse to comply ) any rule1 ord]1 prohibition1 re/riction1 or o!r requirem5t impos$ by ?is ,act or by ! ,adm9i/rator "u ?is ,act2 2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ use & ins]t+ manufacture1 process1 di/ribute 9 comm]ce1 use1 or dispose (2 7,b7 by /rik+ or mixture & ins]t+ 1 mixture1 or article2 & 7,c7 by /rik+ section #e or #f1 a rule or ord] "u section #e or #f1 or an ord] issu$ 9 action br\ght "u section #e or #g & ins]t+ any rule1 ord]1 prohibition1 re/riction1 or o!r requirem5t impos$ by ?is ,act or by ! ,adm9i/rator "u ?is ,act2 7#c7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ accurate & complete aft] ma9ta92 7,b7 9 subp>agraph 7,b7-- 7i7 by ins]t+ or make accurate & complete aft] submit2 & 7ii7 by ins]t+ in=mation submissions1 disclosures1 decl>ations1 c]tifications1 aft] notices12 & 7,c7 9 subp>agraph 7,c71 by /rik+ or aft] ! semicolon2 7#d7 9 p>agraph 7#d71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#e7 by add+ at ! end ! foll[+3 7#e7 make or submit a /atem5t1 decl>ation1 disclosure1 c]tification1 writ+1 data set1 or repres5tation t is mat]ially false1 9 :ole or 9 "p1 or to falsify or conceal any mat]ial fact1 9 tak+ any action or mak+ any communication pursuant to ?is ,act or pursuant to any rule or ord] promulgat$ or issu$ "u ?is ,act2 or 7#f7 take any action prohibit$ by ?is ,act4 4 #af4 ,p5alties ,section #af ( ! ,toxic ,sub/ances ,control ,act 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 by r$esignat+ p>agraphs 7#b71 7#c71 & 7#d7 z p>agraphs 7#c71 7#d71 & 7#e71 respectively2 7,c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+3 7#b7 ,9 ! case ( any violation describ$ 9 p>agraph 7#a71 ! ,adm9i/rator may comm5ce a civil action 9 ! appropriate ,unit$ ,/ates di/rict c\rt to assess p5alties pursuant to t p>agraph4 2 7,d7 9 subp>agraph 7,a7 ( p>agraph 7#c7 7z r$esignat$ by subp>agraph 7,b77-- 7i7 9 ! fir/ s5t5ce1 by ins]t+ ?is ,act1 z describ$ 9 be=e section #ae or #dji2 & 7ii7 9 ! la/ s5t5ce1 by /rik+ )9 #ae days ( & ins]t+ n lat] ?an #ae days aft]2 7,e7 9 ! fir/ s5t5ce ( p>agraph 7#d7 7z r$esignat$ by subp>agraph 7,b77-- 7i7 by /rik+ p>agraph 7#b77;,a7 & ins]t+ p>agraph 7#c77;,a72 & 7ii7 by /rik+ ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit or = any o!r circuit & ins]t+ ! appropriate di/rict c\rt ( ! ,unit$ ,/ates = ! di/rict2 & 7,f7 9 p>agraph 7#e7 7z r$esignat$ by subp>agraph 7,b771 by /rik+ p>agraph 7#c7 ea* place x appe>s & ins]t+ p>agraph 7#d72 & 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+ or willfully2 7,c7 by ins]t+ ?is ,act1 z describ$ 9 aft] any provision (2 7,d7 by /rik+ #be1jjj & ins]t+ #ej1jjj2 7,e7 by /rik+ "o ye> & ins]t+ #e ye>s2 & 7,f7 by add+ at ! end ! foll[+3 7#b7 ,imm95t dang] ( dea? or s]i\s bodily injury 7,a7 ,9 g5]al ,any individual :o kn[+ly violates any provision ( ?is ,act & :o kn[s at ! "t t ! violation places ano!r p]son 9 imm95t dang] ( dea? or s]i\s bodily injury %all ^u conviction be subject to a f9e ( n m ?an #bej1jjj1 or imprisonm5t ( n m ?an #ae ye>s1 or bo?4 7,b7 ,o!r p]sons ,a p]son t is n an individual %all1 ^u conviction ( violat+ ?is p>agraph1 be subject to a f9e ( n m ?an #a1jjj1jjj4 4 #ag4 ,specific en=cem5t & seizure ,section #ag ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfaf7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ 7#a7 ,! di/rict c\rts & all t foll[s ?r\gh ! end ( subp>agraph 7,c7 & ins]t+ ! foll[+3 7#a7 ,au?ority ( ! ,adm9i/rator 7,a7 ,9 g5]al ,! ,adm9i/rator may comm5ce a civil action 9 ! appropriate ,unit$ ,/ates di/rict c\rt to compel compliance ( any p]son ) any provision ( ?is ,act or any rule or ord] promulgat$ pursuant to ?is ,act4 7,b7 ,en=cem5t ,! au?ority ( ! ,adm9i/rator to en=ce ?is ,act includes ! au?ority-- 7i7 to seek civil or crim9al p5alties "u section #af = any violation ( ?is ,act1 z describ$ 9 sections #ae & #dji2 7ii7 to enjo9 any violation ( ?is ,act1 or ( a rule or ord] promulgat$ or issu$ "u ?is ,act1 z describ$ 9 sections #ae & #dji2 7iii7 to ord] ! compliance ( any p]son ) any provision ( ?is ,act1 or ) any rule or ord] promulgat$ or issu$ "u ?is ,act1 ?r\gh an adm9i/rative proce$+ 7:i* may proce$ concurr5tly ) action "u ?is section71 9 :i* ! ,adm9i/rator may levy p5alties "u section #af2 & 2 & 7ii7 9 subp>agraph 7,d7-- 7,i7 by r$esignat+ clause 7i7 ?r\gh 7iii7 z subclauses 7,i7 ?r\gh 7,,iii71 respectively1 & ind5t+ appropriately2 7,,ii7 by /rik+ 7,d7 direct any manufactur] & ins]t+ ! foll[+3 7iv7 to ord] any manufactur] 2 7,,iii7 by /rik+ product subject to title ,,iv & ins]t+ article subject to ?is ,act2 7,,iv7 by /rik+ product ea* place x appe>s & ins]t+ article2 7,v7 by /rik+ ( section #e1 #f1 or title ,,iv & ins]t+ ?is ,act2 & 7,,vi7 by /rik+ "u section #e1 #f1 or title ,,iv & ins]t+ promulgat$ & issu$ "u ?is ,act1 z describ$ 9 section #ae or #dji12 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ 7#b7 ,a civil action & all t foll[s ?r\gh describ$ 9 subp>agraph 7,a7 ( su* p>agraph 9 subp>agraph 7,a7 & ins]t+ ! foll[+3 7#b7 ,civil actions 7,a7 ,9 g5]al ,! di/rict c\rts ( ! ,unit$ ,/ates %all h jurisdiction ov] a civil action describ$ 9 p>agraph 7#a74 7,b7 ,requirem5ts ,a civil action describ$ 9 p>agraph 7#a7 may be br\ght-- 7i7 9 ! case ( a civil action describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 2 7ii7 9 clause 7i7 7z s designat$71 by /rik+ ( section #ae & ins]t+ ( ?is ,act1 z describ$ 9 section #ae or #dji2 7iii7 by r$esignat+ subp>agraph 7,b7 z clause 7ii7 & ind5t+ appropriately2 & 7iv7 9 clause 7ii7 7z s designat$71 by /rik+ su* p>agraph & ins]t+ p>agraph 7#a72 & 7,c7 9 ! undesignat$ matt] foll[+ p>agraph 7#b71 by /rik+ ,9 any & ins]t+ ! foll[+3 7#c7 ,s]v+ ( process & subpo5as ,9 any 2 & 7#b7 9 ! fir/ s5t5ce ( subsection 7b7-- 7,a7 by /rik+ title ,,iv & ins]t+ ?is ,act2 7,b7 by /rik+ product ! fir/ place x appe>s & ins]t+ article2 & 7,c7 by /rik+ product1 bo? places x appe>s4 #ah4 ,preemption ,section #ah ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfag7 is am5d$ to read z foll[s3 #ah4 ,preemption ,no?+ 9 ?is ,act affects ! "r ( a ,/ate or a political subdivision ( a ,/ate to adopt or en=ce any regulation1 requirem5t1 or /&>d ( p]=mance t is diff]5t f1 or 9 addition to1 a regulation1 requirem5t1 liability1 or /&>d ( p]=mance e/abli%$ pursuant to ?is ,act unless compliance ) bo? ?is ,act & ! ,/ate or political subdivision ( a ,/ate regulation1 requirem5t1 or /&>d ( p]=mance is impossible1 9 :i* case ! applicable provisions ( ?is ,act %all control4 4 #ai4 ,judicial review ,section #ai ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfah7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ subp>agraph 7,b72 7ii7 9 subp>agraph 7,a71 by /rik+ 7#a77;,a7 ,n lat] & all t foll[s ?r\gh "u title ,,ii or ,,iv1 & ins]t+ ! foll[+3 7#a7 ,judicial review ,n lat] ?an #fj days aft] ! date ( ! promulgation or issuance ( a rule "u ( ?is ,act1 2 7iii7 by ins]t+ or ord] aft] rule ea* place x appe>s2 & 7iv7 9 ! second s5t5ce1 by /rik+ 7o!r ?an 9 an en=cem5t proce$+72 7,b7 9 p>agraph 7#b7-- 7i7 9 ! fir/ s5t5ce1 by /rik+ p>agraph 7#a77;,a7 & ins]t+ p>agraph 7#a72 & 7ii7 9 ! second s5t5ce1 by ins]t+ or ord] aft] rule2 & 7,c7 by /rik+ p>agraph 7#c72 7#b7 9 subsection 7b71 by ins]t+ or ord] aft] rule ea* place x appe>s2 & 7#c7 9 subsection 7c71 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,^u ! fil+ ( a petition "u subsection 7a77#a7 = judicial review ( a rule or ord]1 ! c\rt %all h jurisdiction-- 7,a7 to grant appropriate relief1 includ+ int]im relief1 z provid$ 9 *apt] #g ( title #e1 ,unit$ ,/ates ,code2 & 7,b7 to review ! rule or ord] 9 accordance ) t *apt]4 4 #bj4 ,citiz5s' civil action ,section #bj ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfai7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by /rik+ "u section #d1 #e1 or #f1 or title ,,ii or ,,iv1 or ord] issu$ "u section #e or title ,,ii or ,,iv to re/ra9 su* violation1 & ins]t+ or ord] issu$ "u ?is ,act22 & 7,b7 9 ! ?ird s5t5ce ( ! undesignat$ language foll[+ p>agraph 7#b71 by ins]t+ 1 to en=ce ?is ,act or any rule promulgat$ or ord] issu$ "u ?is ,act1 or to ord] ! ,adm9i/rator to p]=m an act or duty describ$ 9 ?is ,act1 z ! case may be aft] citiz5%ip ( ! p>ties2 & 7#b7 9 subsection 7b77#a71 by /rik+ to re/ra9 & ins]t+ respect+4 #ba4 ,citiz5s' petitions ,section #ba ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbj7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ "u section #d1 #f1 or #h or an ord] "u section #e7;e7 or 7#f77;b77#b7 & ins]t+ 1 ord]1 or any o!r action au?oriz$ "u ?is ,act2 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 by /rik+ "u section #d1 #f1 or #h or an ord] "u section #e7;e71 #f7;b77#a77;,a71 or #f7;b77#a77;,b7 & ins]t+ or ord] or to initiate o!r action au?oriz$ "u ?is ,act2 7,b7 9 ! fir/ s5t5ce ( p>agraph 7#c71 by /rik+ section #d1 #e1 #f1 or #h & ins]t+ ! applicable provisions ( ?is ,act2 & 7,c7 9 p>agraph 7#d7-- 7i7 9 ! fir/ s5t5ce ( subp>agraph 7,a71 by /rik+ a rulemak+ proce$+ & ins]t+ proce$+s au?oriz$ "u ?is ,act2 & 7ii7 9 subp>agraph 7,b7-- 7,i7 9 ! matt] prec$+ clause 7i7-- 7aa7 9 ! fir/ s5t5ce1 by /rik+ a proce$+ to issue a rule "u section #d1 #f1 or #h or an ord] "u section #e7;e7 or #f7;b77#b7 & ins]t+ proce$+s au?oriz$ "u ?is ,act2 & 7bb7 by ins]t+ ,not)/&+ ! prec$+ s5t5ce1 9 ! case ( a petition to deli/ a *emical sub/ance "u section #f7;a71 ! deli/+ may n proce$ except z au?oriz$ "u t subsection4 aft] ! fir/ s5t5ce2 7,,ii7 9 clause 7i7-- 7aa7 9 ! matt] prec$+ subclause 7,i71 by /rik+ 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule "u section #d or an ord] "u section #e7;e7 & ins]t+ except z provid$ 9 clause 7ii71 9 ! case ( a petition to initiate a proce$+ = ! issuance ( a rule or an ord] "u ?is ,act2 & 7bb7 9 subclause 7,,ii71 by /rik+ an unreasonable risk to & ins]t+ sub/antial endang]m5t2 & 7,,iii7 9 clause 7ii7-- 7aa7 by /rik+ issuance ( a rule "u section #f or #h or an ord] "u section #f7;b77#b7 & ins]t+ imposition or issuance ( a re/riction1 use condition1 or ord] "u ?is *apt]2 7bb7 by /rik+ an unreasonable risk ( injury & ins]t+ a sub/antial endang]m5t2 & 7cc7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon4 #bb4 ,employm5t effects ,section #bd ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbc7 is am5d$-- 7#a7 9 subsection 7a71 9 ! matt] prec$+ p>agraph 7#a7-- 7,a7 by /rik+ cont9u+ & ins]t+ p]iodic2 & 7,b7 by /rik+ plant closures7 & all t foll[s ?r\gh ! end ( p>agraph 7#b7 & ins]t+ plant closures7 ( ! implem5tation ( ?is ,act42 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 9 ! undesignat$ language foll[+ subp>agraph 7,b71 by /rik+ section #d1 #e1 or #f or a requirem5t ( section #e or #f & ins]t+ ?is ,act2 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a77ii71 by /rik+ by ord] issu$ & ins]t+ 9 writ+12 & 7ii7 9 subp>agraph 7,b7-- 7,i7 9 clause 7i71 by /rik+ ! comma aft] su* reque/ & ins]t+ 2 &2 7,,ii7 by /rik+ clause 7ii72 & 7,,iii7 by r$esignat+ clause 7iii7 z clause 7ii72 & 7,c7 by /rik+ p>agraph 7#d72 & 7#c7 by add+ at ! end ! foll[+3 7c7 ,effect ,no?+ 9 ?is section-- 7#a7 requires ! ,adm9i/rator to am5d or repeal any rule or ord] 9 effect "u ?is ,act2 or 7#b7 conditions ! au?ority ( ! ,adm9i/rator to issue ord]s or promulgate rules "u ?is ,act4 4 #bc4 ,adm9i/ration ( ! ,toxic ,sub/ances ,control ,act ,section #bf ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbe7 is am5d$-- 7#a7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,fees 7#a7 ,9 g5]al ,! ,adm9i/rator may1 by rule1 require ! paym5t ( a reasonable fee f any p]son requir$ to submit data to defray ! co/ ( adm9i/]+ ?is ,act4 7#b7 ,consid]ations ,9 sett+ a fee "u ?is subsection1 ! ,adm9i/rator %all take into acc\nt-- 7,a7 ! ability to pay ( ! p]son requir$ to submit ! data2 & 7,b7 ! co/ to ! ,adm9i/rator ( review+ ! data4 7#c7 ,fee %>+ ,rules describ$ 9 p>agraph 7#a7 may provide = %>+ a fee 9 any case 9 :i* ! exp5ses ( te/+ are %>$ "u ?is ,act4 2 7#b7 9 subsection 7c7-- 7,a7 9 ! subsection head+1 by add+ & mixtures aft] categories2 & 7,b7 by add+ at ! end ! foll[+3 7#c7 ,mixtures ,any action au?oriz$ or requir$ to be tak5 by ! ,adm9i/rator or any o!r p]son "u any provision ( ?is ,act ) respect to a *emical sub/ance is likewise also au?oriz$ or requir$ ) respect to a mixture1 if ! ,adm9i/rator det]m9es t su* ext5sion is reasonable & effici5t4 2 & 7#c7 by add+ at ! end ! foll[+3 7h7 ,rulemak+ or ord]s ,9 c>ry+ out ?is ,act1 ! ,adm9i/rator may issue su* ord]s & prescribe su* regulations z are necess>y to c>ry out ?is ,act4 4 #bd4 ,/ate programs ,section #bh ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfbg7 is am5d$-- 7#a7 9 ! fir/ s5t5ce ( subsection 7a7-- 7,a7 by /rik+ unreasonable2 & 7,b7 by /rik+ is unable or is n likely to take & ins]t+ has n tak52 7#b7 by r$esignat+ subsections 7b71 7c71 & 7d7 z subsections 7c71 7d71 & 7e71 respectively2 7#c7 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,coord9ation ,! ,adm9i/rator %all e/abli% a process to coord9ate ) ,/ates1 on an on-go+ basis1 to %>e data & priorities relat+ to ! managem5t ( *emical sub/ances "u ?is title & "u programs op]at$ by ,/ates1 9 accordance ) section #ad4 2 & 7#d7 9 subsection 7c77#b7 7z r$esignat$ by p>agraph 7#b771 by /rik+ includ+ canc]1 bir? defects1 & g5e mutations14 #be4 ,au?orization ( appropriations ,title ,i ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq47 is am5d$-- 7#a7 by r$esignat+ section #bi 7#ae ,u4,s4,c4 #bfbh7 z section #ch2 7#b7 by r$esignat+ section #cj 7#ae ,u4,s4,c4 #bfbi7 z section #cg2 7#c7 by /rik+ section #ca 7,public ,law #id-dfi2 #ajj ,/at4 #bihi72 & 7#d7 by am5d+ section #ch 7z r$esignat$ by p>agraph 7#a77 to read z foll[s3 #ch4 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to ! ,adm9i/rator to c>ry out ?is ,act su* sums z are necess>y = ea* ( fiscal ye>s #bjac ?r\gh #bjbj4 4 #bf4 ,additional requirem5ts 7a7 ,re/rictions on c]ta9 *emical sub/ances ,! ,toxic ,sub/ances ,control ,act is am5d$ by ins]t+ aft] section #bh 7#ae ,u4,s4,c4 #bfbg7 ! foll[+3 #bi4 ,*ildr5's ,environm5tal ,heal? ,rese>* ,program 7a7 ,*ildr5's ,environm5tal ,heal? ,rese>* ,program 7#a7 ,e/abli%m5t ,n lat] ?an #ij days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all e/abli% )9 ! ,environm5tal ,protection ,ag5cy a program to be kn[n z ! ,*ildr5s ,environm5tal ,heal? ,rese>* ,program' 7ref]r$ to 9 ?is subsection z ! ,program74 7#b7 ,purpose ,subject to am\nts made available 9 advance 9 appropriations ,acts1 ! ,adm9i/rator may ent] into contracts & make grants "u ! ,program to fur!r und]/&+ ( ! vuln]ability ( *ildr5 to *emical sub/ances & mixtures4 7#c7 ,consultation ,contracts & grants "u ?is section %all be provid$ 9 consultation ) ! ,int]ag5cy ,sci5ce ,advisory ,bo>d on ,*ildr5's ,heal? ,rese>* e/abli%$ "u subsection 7b77#a74 7b7 ,int]ag5cy ,sci5ce ,advisory ,bo>d on ,*ildr5's ,heal? ,rese>* 7#a7 ,e/abli%m5t ,n lat] ?an #ij days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all e/abli% an advisory bo>d to be kn[n z ! ,int]ag5cy ,sci5ce ,advisory ,bo>d on ,*ildr5s ,heal? ,rese>*' 7ref]r$ to 9 ?is subsection z ! ,bo>d74 7#b7 ,purpose ,! purpose ( ! ,bo>d %all be to provide indep5d5t advice1 exp]t consultation1 & pe] review1 on reque/ ( ! ,adm9i/rator or ,congress1 ) respect to ! sci5tific & te*nical aspects ( issues relat+ to ! implem5tation ( ?is title ) respect to rese>* on protect+ *ildr5's heal?4 7#c7 ,composition ,! ,adm9i/rator %all-- 7,a7 appo9t ! memb]s ( ! ,bo>d1 includ+1 at a m9imum1 repres5tatives (-- 7i7 ! ,national ,in/itute ( ,environm5tal ,heal? ,sci5ces2 7ii7 ! ,c5t]s = ,disease ,control & ,prev5tion2 7iii7 ! ,national ,toxicology ,program2 7iv7 ! ,national ,canc] ,in/itute2 7v7 ! ,national ,,epa-,tribal ,sci5ce ,c\ncil2 & 7vi7 n few] ?an #c c5t]s ( *ildr5's heal? at lead+ in/itutions ( high] education2 7,b7 ensure t at lea/ #a_/c ( ! memb]s ( ! ,bo>d h specific sci5tific exp]tise 9 ! relation%ip ( *emical exposures to pr5atal1 infant1 & *ildr5's heal?2 & 7,c7 ensure t no individual appo9t$ to s]ve on ! ,bo>d has a conflict ( int]e/ t is relevant to ! functions p]=m$ by ! ,bo>d1 unless-- 7i7 ! individual promptly & publicly discloses ! conflict2 & 7ii7 ! ,adm9i/rator det]m9es t ! conflict is unavoidable4 7#d7 ,applicable law ,! ,bo>d %all be subject to sub*apt] ,,ii ( *apt] #e1 & *apt] #g1 ( title #e1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,adm9i/rative ,proc$ure ,act74 7c7 ,pr5atal & infant exposures 7#a7 ,monitor+ ,if1 ?r\gh /udies p]=m$ "u subsection 7a7 or section #d or 9 any o!r available rese>*1 ! ,adm9i/rator id5tifies a *emical sub/ance t may be pres5t 9 human biological m$ia t may h adv]se effects on e>ly *ildhood developm5t1 ! ,adm9i/rator %all coord9ate ) ! ,secret>y ( ,heal? & ,human ,s]vices to conduct1 n lat] ?an #b ye>s aft] ! date on :i* ! ,adm9i/rator id5tifies ! *emical sub/ance1 a biomonitor+ /udy to det]m9e ! pres5ce ( ! *emical sub/ance 9 human biological m$ia 91 at a m9imum1 pregnant wom5 & infants4 7#b7 ,publication ,on completion ( any /udy conduct$ "u p>agraph 7#a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7,a7 notify ! ,adm9i/rator ( ! results ( ! /udy2 & 7,b7 publi% ! results ( ! /udy 9 a publicly available electronic =mat4 7#c7 ,positive results 7,a7 ,manufacture disclosure ,if a *emical sub/ance or mixture is det]m9$ to be pres5t 9 a /udy conduct$ "u p>agraph 7#a71 ! manufactur]s & processors ( ! *emical sub/ance or mixture %all1 n lat] ?an #ahj days aft] ! date ( publication ( ! /udy1 disclose to ! ,adm9i/rator1 comm]cial cu/om]s ( ! manufactur]s & processors1 consum]s1 & ! public-- 7i7 all kn[n uses ( ! *emical sub/ance or mixture2 & 7ii7 all articles 9 :i* ! *emical sub/ance or mixture is1 or is expect$ to be1 pres5t4 7,b7 ,co/ & =m ( disclosure ,in=mation "u clauses 7i7 & 7ii7 ( subp>agraph 7,a7 %all be-- 7i7 made available by ! ,adm9i/rator 9 electronic =mat2 & 7ii7 made readily accessible & free ( *>ge by ea* applicable manufactur] & processor 9 electronic =mat to ! comm]cial cu/om]s ( su* manufactur] or processor1 consum]s1 & ! public4 #cj4 ,r$uction ( animal-bas$ te/+ 7a7 ,adm9i/ration ,! ,adm9i/rator %all take action to m9imize ! use ( animals 9 te/+ ( *emical sub/ances or mixtures1 includ+-- 7#a7 enc\rag+ & facilitat+1 to ! maximum ext5t practicable-- 7,a7 ! use ( exi/+ data ( suffici5t sci5tific quality2 7,b7 ! use ( te/ me?ods t elim9ate or r$uce ! use ( animals :ile provid+ data ( high sci5tific quality2 7,c7 ! gr\p+ ( #b or m *emical sub/ances into sci5tifically appropriate categories 9 cases 9 :i* te/+ ( #a *emical sub/ance w\ld provide reliable & useful data on o!rs 9 ! category2 7,d7 ! =mation ( indu/ry consortia to jo9tly conduct te/+ to avoid unnecess>y duplication ( te/s2 & 7,e7 ! p>allel submission ( data f animal-bas$ /udies & f em]g+ me?ods & models2 & 7#b7 fund+ rese>* & validation /udies to r$uce1 ref9e1 & replace ! use ( animal te/s 9 accordance ) ?is subsection4 7b7 ,int]ag5cy sci5ce advisory bo>d on alt]native te/+ me?ods 7#a7 ,e/abli%m5t ,n lat] ?an #ij days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all e/abli% an advisory bo>d to be kn[n z ! ,int]ag5cy ,sci5ce ,advisory ,bo>d on ,alt]native ,te/+ ,me?ods 7ref]r$ to 9 ?is subsection & subsection 7c7 z ! ,bo>d74 7#b7 ,composition ,! ,adm9i/rator %all-- 7,a7 appo9t ! memb]s ( ! ,bo>d1 includ+1 at a m9imum1 repres5tatives (-- 7i7 ! ,national ,in/itute ( ,environm5tal ,heal? ,sci5ces2 7ii7 ! ,c5t]s = ,disease ,control & ,prev5tion2 7iii7 ! ,national ,toxicology ,program2 7iv7 ! ,national ,canc] ,in/itute2 & 7v7 ! ,national ,,epa-,tribal ,sci5ce ,c\ncil2 & 7,b7 ensure t no individual appo9t$ to s]ve on ! ,bo>d has a conflict ( int]e/ t is relevant to ! functions to be p]=m$1 unless-- 7i7 ! individual promptly & publicly discloses ! conflict2 & 7ii7 ! ,adm9i/rator det]m9es t ! conflict is unavoidable4 7#c7 ,purpose ,! purpose ( ! ,bo>d %all be to provide indep5d5t advice & pe] review to ,congress & ! ,adm9i/rator on ! sci5tific & te*nical aspects ( issues relat+ to ! implem5tation ( ?is title ) respect to m9imiz+ ! use ( animals 9 te/+ *emical sub/ances or mixtures4 7#d7 ,applicable law ,! ,bo>d %all be subject to sub*apt] ,,ii ( *apt] #e1 & *apt] #g1 ( title #e1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,adm9i/rative ,proc$ure ,act74 7#e7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 & e #c ye>s !reaft]1 ! ,adm9i/rator1 9 consultation ) ! ,bo>d1 %all publi% 9 ! ,f$]al ,regi/] a li/ ( te/+ me?ods t r$uce ! use ( animals 9 te/+ "u section #d4 7c7 ,implem5tation ( alt]native te/+ me?ods ,to promote ! developm5t & timely incorporation ( new te/+ me?ods t are n animal-bas$1 ! ,adm9i/rator %all-- 7#a7 9 consultation ) ! ,bo>d1 & 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$ = safety /&>d det]m9ations "u section #f7;b7 t d n use animals1 includ+ toxicity pa?way-bas$ risk assessm5t1 9 vitro /udies1 sy/ems biology1 computational toxicology1 bio9=matics1 & high-?r\ghput scre5+2 7#b7 beg9n+ on ! date t is #b ye>s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac & e #b ye>s !reaft]1 submit to ,congress a report t describes ! progress made 9 implem5t+ ?is section2 & 7#c7 fund & c>ry out rese>*1 developm5t1 p]=mance assessm5t1 & translational /udies to accel]ate ! developm5t ( te/ me?ods & te/+ /rategies t are n animal-bas$ = use 9 safety /&>d det]m9ations "u section #f7;b74 7d7 ,crit]ia = adapt+ or waiv+ animal te/+ requirem5ts ,on reque/ f a manufactur] or processor t is requir$ to conduct animal-bas$ te/+ ( a *emical sub/ance or mixture "u ?is title1 ! ,adm9i/rator may adapt or waive ! animal te/+ requirem5t if ! ,adm9i/rator det]m9es t-- 7#a7 !re is a suffici5t weight ( evid5ce f sev]al indep5d5t s\rces ( in=mation to support a conclusion t a *emical sub/ance or mixture has1 or does n h1 a p>ticul> prop]ty1 9 any case 9 :i* ! in=mation f ea* individual s\rce alone is reg>d$ z insuffici5t to support ! conclusion2 7#b7 because ( #a or m physical or *emical prop]ties ( ! *emical sub/ance or mixture1 te/+ = a specific endpo9t is te*nically n practicable to conduct2 or 7#c7 a *emical sub/ance or mixture _c be te/$ 9 animals at conc5trations t d n result 9 significant pa9 or di/ress1 because ( physical or *emical prop]ties ( ! *emical sub/ance or mixture1 su* z pot5tial to cause sev]e corrosion or sev]e irritation to tissues4 #ca4 ,saf] alt]natives & gre5 *emi/ry & eng9e]+ 7a7 ,saf] alt]natives program 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all e/abli% a program to create m>ket inc5tives = ! developm5t ( saf] alt]natives to exi/+ *emical sub/ances t r$uce or avoid ! use & g5]ation ( haz>d\s sub/ances4 7#b7 ,requirem5ts ,! program e/abli%$ "u p>agraph 7#a7 %all include-- 7,a7 exp$it$ review ( new *emical sub/ances = :i* ! manufactur] or processor submits an alt]natives analysis indicat+ t ! new *emical sub/ance is ! saf] alt]native = a p>ticul> use ?an exi/+ *emical sub/ances us$ = ! same purpose2 7,b7 recognition = a *emical sub/ance or product det]m9$ by ! ,adm9i/rator to be a saf] alt]native = a p>ticul> use by means ( a special designation int5d$ = use 9 m>ket+ ! saf] alt]native1 & p]iodic public aw>ds or rew>ds2 & 7,c7 su* o!r inc5tives1 z ! ,adm9i/rator consid]s to be appropriate to enc\rage ! developm5t1 m>ket+1 & use ( *emical sub/ances or products det]m9$ by ! ,adm9i/rator to be saf] alt]natives = ! p>ticul> uses1 su* z job tra9+ & work] assi/ance4 7b7 ,gre5 *emi/ry rese>* network ,! ,adm9i/rator %all e/abli% a network ( n less ?an #d gre5 *emi/ry & eng9e]+ c5t]s1 locat$ 9 v>i\s regions ( ! ,unit$ ,/ates1 to support ! developm5t & adoption ( saf] alt]natives to *emical sub/ances1 p>ticul>ly *emical sub/ances li/$ "u section #f7;a74 7c7 ,gre5 *emi/ry & eng9e]+ rese>* grants ,! ,adm9i/rator %all make grants to promote & support ! rese>*1 developm5t1 & adoption ( saf] alt]natives to haz>d\s sub/ances4 7d7 ,gre5 *emi/ry work=ce education & tra9+ program 7#a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% a program to facilitate ! developm5t ( a work=ce1 includ+ indu/rial & sci5tific work]s1 t produces saf] alt]natives to exi/+ *emical sub/ances4 7#b7 ,goals ,! goals ( ! program e/abli%$ "u p>agraph 7#a7 are to provide work=ce tra9+ on skills t w\ld-- 7,a7 facilitate ! expansion ( gre5 *emi/ry2 7,b7 develop sci5tific & te*nical lead]%ip 9 gre5 *emi/ry2 7,c7 facilitate ! successful & safe integration ( gre5 *emi/ry into infra/ructure projects2 7,d7 in=m & engage communities ab\t gre5 *emi/ry2 & 7,e7 promote innovation & /rong public heal? & environm5tal protections4 7#c7 ,implem5tation ,! ,adm9i/rator %all implem5t ! program to a*ieve ! goals ( ?is ,act1 includ+ by-- 7,a7 help+ to develop a broad range ( skills relevant to ! production & use ( ! saf] alt]natives1 includ+ ! design1 manufactur+1 use1 & disposal ( ! alt]natives2 7,b7 (f]+ to develop p>tn]%ips ) educational in/itutions1 tra9+ organizations1 private sector companies1 & community organizations2 & 7,c7 provid+ grants to ,/ates1 units ( local gov]nm5t1 & ! p>tn]%ips develop$ "u subp>agraph 7,b7 to promote & support activities consi/5t ) a*iev+ ! goals ( ! program e/abli%$ "u ?is subsection4 #cb4 ,coop]ation ) int]national ef=ts ,9 coop]ation ) ! ,secret>y ( ,/ate & ! head ( any o!r appropriate ,f$]al ag5cy 7z det]m9$ by ! ,adm9i/rator71 ! ,adm9i/rator %all coop]ate ) int]national ef=ts z appropriate-- 7#a7 to develop a common protocol or electronic database relat+ to *emical sub/ances2 or 7#b7 to develop saf] alt]natives = *emical sub/ances4 #cc4 ,reliable in=mation & advice ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all1 by ord]1 e/abli% & implem5t proc$ures to ensure data reliability includ+1 at a m9imum1 requirem5ts t ! ,adm9i/rator-- 7#a7 n less ?an annually r&omly inspect laboratories t develop ! data requir$ "u ?is title on ! v>i\s prop]ties & *>act]i/ics ( a *emical sub/ance2 7#b7 annually p]=m a compreh5sive data audit on a subset1 z *os5 by ! ,adm9i/rator1 ( ! data submissions "u ?is title2 7#c7 e/abli% & ma9ta9 a regi/ry ( all heal?- & safety-relat$ /udies initiat$ 9 response to requirem5ts "u ?is title2 7#d7 h access to all records ( heal?- & safety-relat$ /udies initiat$ 9 response to requirem5ts "u ?is title2 & 7#e7 require ! submitt] ( any rese>* /udy conduct$ by a ?ird p>ty 9 response to requirem5ts "u ?is title to disclose to ! ,adm9i/rator & ! public1 at ! "t ( submission1 ! s\rces ( any fund+ us$ = ! conduct or publication ( ! /udy receiv$ by ! rese>*]s :o conduct$ ! /udy4 #cd4 ,hot spots 7a7 ,def9itions ,9 ?is section3 7#a7 ,disproportionate exposure ,! t]m disproportionate exposure means resid5tial population exposure to #a or m toxic *emical sub/ances or mixtures at levels t are significantly great] ?an ! av]age exposure 9 ! ,unit$ ,/ates1 z def9$ & id5tifi$ by ! ,adm9i/rator 9 accordance ) ! crit]ia e/abli%$ "u subsection 7b74 7#b7 ,locality ,! t]m locality means any geographical area 7includ+ a c\nty1 city1 t[n1 neighborhood1 c5sus tract1 zip code area1 or o!r commonly und]/ood political or geographical subdivision7 9 :i* ! ,adm9i/rator id5tifies disproportionate exposure4 7b7 ,crit]ia ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,safe ,*emicals ,act ( #bjac1 ! ,adm9i/rator %all promulgate a rule to e/abli% crit]ia consi/5t ) ?is section t-- 7#a7 def9es disproportionate exposure2 & 7#b7 id5tifies any locality t is disproportionately expos$4 7c7 ,id5tification 7#a7 ,9 g5]al ,n lat] ?an #abj days aft] ! date on :i* ! rule is promulgat$ "u subsection 7b71 ! ,adm9i/rator %all id5tify localities 9 ! ,unit$ ,/ates t are subject to disproportionate exposure4 7#b7 ,use ( data ,9 id5tify+ localities "u p>agraph 7#a71 ! ,adm9i/rator-- 7,a7 %all use data conta9$ 9 ! ,national ,air ,toxic ,assessm5t ,database2 & 7,b7 may use o!r data available to ! ,adm9i/rator1 includ+ data develop$ "u-- 7i7 ! ,safe ,dr9k+ ,wat] ,act 7#db ,u4,s4,c4 #cjj;f et seq472 7ii7 ! ,solid ,wa/e ,disposal ,act 7#db ,u4,s4,c4 #fija et seq472 7iii7 ! ,compreh5sive ,environm5tal ,response1 ,comp5sation1 & ,liability ,act ( #aihj 7#db ,u4,s4,c4 #ifja et seq472 & 7iv7 ! ,em]g5cy ,plann+ & ,community ,"r-to-,"k ,act ( #aihf 7#db ,u4,s4,c4 #aajja et seq474 7#c7 ,public p>ticipation ,! ,adm9i/rator %all provide an opportunity = memb]s ( ! public to nom9ate localities 9 :i* disproportionate exposure may be f\nd = inclusion 9 ! id5tification ( localities "u p>agraph 7#a74 7d7 ,locality li/ 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] complet+ ! id5tification ( localities "u subsection 7c77#a71 ! ,adm9i/rator1 aft] notice & consultation ) applicable ,/ate1 local1 c\nty heal?1 & environm5tal (ficials1 ,/ate1 local1 & c\nty legislators1 & o!r elect$ (ficials1 %all-- 7,a7 publi% a li/ ( ! localities subject to disproportionate exposure id5tifi$ "u t subsection 9 ! ,f$]al ,regi/]2 & 7,b7 make ! li/ publi%$ "u subp>agraph 7,a7 available electronically4 7#b7 ,updat$ li/ 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 n lat] ?an #e ye>s aft] ! date on :i* ! li/ is publi%$ "u p>agraph 7#a77;,a71 & at lea/ once e #e ye>s !reaft]1 ! ,adm9i/rator %all update & republi% ! li/4 7,b7 ,discretion>y updates ,! ,adm9i/rator may update & republi% ! li/ "u p>agraph 7#a7 m frequ5tly ?an e #e ye>s-- 7i7 to add new localities t meet ! crit]ia e/abli%$ "u subsection 7b72 or 7ii7 to remove localities1 if ! ,adm9i/rator det]m9es t ! exposure r$uction has be5 a*iev$ & no fur!r action is ne$$ aft] actions are tak5 "u subsection 7f74 7,c7 ,notification ,! ,adm9i/rator %all notify all applicable ,/ate1 local1 c\nty heal?1 & environm5tal (ficials1 ,/ate1 local1 & c\nty legislators1 & o!r elect$ (ficials ( ! updat$ li/+4 7e7 ,no judicial review2 nondiscretion>y duty 7#a7 ,no judicial review ,! foll[+ actions "u ?is section %all n be subject to judicial review3 7,a7 ,a decision to include on ! li/ publi%$ "u subsection 7d77#a7 a locality id5tifi$ "u subsection 7c77#a74 7,b7 ,a decision 9 response to nom9ations submitt$ "u subsection 7c77#c74 7,c7 ,a decision to li/ localities "u subsection 7d77#a7 or update ! li/ "u subsection 7d77#b74 7#b7 ,nondiscretion>y duty ,not)/&+ p>agraph 7#a71 ! failure ( ! ,adm9i/rator to publi% or update ! li/ ( localities 9 accordance ) ?is section %all be-- 7,a7 consid]$ to be a failure to p]=m a nondiscretion>y duty2 & 7,b7 subject to judicial review4 7f7 ,action plans 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date on :i* ! li/ is publi%$ or updat$ "u subsection 7d71 ! ,adm9i/rator %all develop & publi%1 = ea* locality id5tifi$ on ! li/1 an action plan t includes-- 7,a7 an id5tification ( ! *emical sub/ances & mixtures t contribute to ! disproportionate exposure 7includ+ exposure levels1 s\rces1 & pa?ways72 & 7,b7 a description ( actions plann$ by ! ,adm9i/rator to r$uce disproportionate exposure 9 ! locality4 7#b7 ,goals ,! goal ( ea* action plan "u ?is subsection %all be to r$uce disproportionate exposure 9 ! locality by e/abli%+-- 7,a7 a p]c5tage exposure r$uction goal = ea* *emical sub/ance & mixture2 & 7,b7 a timel9e to a*ieve ! p]c5tage exposure r$uction goal4 7g7 ,report to ,congress ,! ,adm9i/rator %all-- 7#a7 submit to ,congress an annual report t id5tifies-- 7,a7 ea* locality add$ to ! li/ 9 ! prior ye> "u subsection 7d72 7,b7 ea* action plan develop$ 9 ! prior ye> "u subsection 7f72 & 7,c7 ! progress on ea* action plan to date2 & 7#b7 make ! report available to ! public 9 electronic =mat4 #ce4 ,application ( ?is ,act to ,f$]al ag5cies 7a7 ,9 g5]al ,except z provid$ 9 subsection 7e71 ea* ,f$]al ag5cy1 & any (fic]1 ag5t1 or employee ( a ,f$]al ag5cy1 %all be subject to1 & comply )1 all applicable requirem5ts ( ?is ,act describ$ 9 subsection 7b71 bo? sub/antive & proc$ural1 9 ! same mann]1 & to ! same ext5t1 z any p]son subject to ! requirem5ts4 7b7 ,description ( requirem5ts ,! sub/antive & proc$ural requirem5ts ref]r$ to 9 ?is subsection include-- 7#a7 any adm9i/rative ord]2 7#b7 any civil or adm9i/rative p5alty or f9e1 reg>dless ( :e!r ! p5alty or f9e is-- 7,a7 punitive or co]cive 9 nature2 or 7,b7 impos$ = isolat$1 int]mitt5t1 or cont9u+ violations2 7#c7 any requirem5t = report+2 7#d7 any provision = injunctive relief & sanctions t may be impos$ by a c\rt to en=ce su* relief2 & 7#e7 paym5t ( reasonable s]vice *>ges4 7c7 ,waiv] ( immunity ,! ,unit$ ,/ates expressly waives any immunity o!rwise applicable to ! ,unit$ ,/ates ) respect to any sub/antive or proc$ural requirem5t ref]r$ to "u subsection 7a74 7d7 ,civil p5alties ,no ag5t1 employee1 or (fic] ( ! ,unit$ ,/ates %all be p]sonally liable = any civil p5alty "u ?is title ) respect to any act or omission )9 ! scope ( ! (ficial duties ( ! ag5t1 employee1 or (fic]4 7e7 ,crim9al sanctions ,an ag5t1 employee1 or (fic] ( ! ,unit$ ,/ates %all be subject to any crim9al sanction 7includ+ any f9e or imprisonm5t7 "u ?is ,act1 b no dep>tm5t1 ag5cy1 or in/rum5tality ( ! executive1 legislative1 or judicial bran* ( ! ,f$]al ,gov]nm5t %all be subject to su* sanction4 7f7 ,exemption 7#a7 ,9 g5]al ,if ! ,presid5t det]m9es x is 9 ! p>am\nt int]e/ ( ! ,unit$ ,/ates1 ! ,presid5t may grant an exemption = any ,f$]al ag5cy f compliance ) any requirem5t ( ?is ,act4 7#b7 ,lack ( appropriation ,no exemption %all be grant$ "u p>agraph 7#a7 due to lack ( appropriation unless-- 7,a7 ! ,presid5t has specifically reque/$ ! appropriation z a "p ( ! budget>y process2 & 7,b7 ,congress has fail$ to make ! reque/$ appropriation available4 7#c7 ,p]iod ( exemption ,any exemption grant$ "u p>agraph 7#a7 %all be = a p]iod ( n m ?an #a ye>1 b additional exemptions may be grant$ = p]iods n to exce$ #a ye>1 if ! ,presid5t makes a subsequ5t det]m9ation t ! exemption is 9 ! p>am\nt int]e/ ( ! ,unit$ ,/ates4 7#d7 ,report ,ea* ,janu>y aft] ! date ( enactm5t ( ?is section1 ! ,presid5t %all submit to ,congress a report t describes-- 7,a7 all exemptions grant$ "u ?is subsection dur+ ! prec$+ cal5d> ye>2 & 7,b7 ! reason = grant+ ea* exemption4 7g7 ,adm9i/rative en=cem5t actions 7#a7 ,9 g5]al ,! ,adm9i/rator may initiate an adm9i/rative en=cem5t action aga9/ any ,f$]al ag5cy-- 7,a7 9 accordance ) ! en=cem5t au?orities ( ?is ,act2 & 7,b7 9 ! same mann] & "u ! same circum/ances z an action w\ld be initiat$ aga9/ ano!r p]son4 7#b7 ,settlem5t ,any volunt>y resolution or settlem5t ( an adm9i/rative en=cem5t action initiat$ "u ?is subsection %all be set =? 9 a cons5t ord]4 7#c7 ,f9ality ( adm9i/rative ord] ,no adm9i/rative ord] issu$ to a ,f$]al dep>tm5t1 ag5cy1 or in/rum5tality "u ?is subsection %all become f9al until ! ,f$]al dep>tm5t1 ag5cy1 or in/rum5tality has _h ! opportunity to conf] ) ! ,adm9i/rator4 #cf4 ,implem5tation ( ,/ockholm ,conv5tion1 ! ,,lrtap ,pops ,protocol1 & ! ,rott]dam ,conv5tion 7a7 ,def9itions ,9 ?is section3 7#a7 ,*emical ,! t]m *emical includes any sub/ance or mixture ( sub/ances1 includ+ a sub/ance t is "p ( an article4 7#b7 ,,lrtap ,conv5tion ,! t]m ,,lrtap ,conv5tion means ! ,conv5tion on ,long-,range ,transb\nd>y ,air ,pollution1 done at ,g5eva on ,novemb] #ac1 #aigi 7,,tias #ajeda71 & any subsequ5t am5dm5ts to :i* ! ,unit$ ,/ates is a p>ty4 7#c7 ,,lrtap ,pops *emical ,! t]m ,,lrtap ,p,o,ps *emical means any *emical li/$ on any ,annex ( ! ,,lrtap ,p,o,ps ,protocol1 if su* li/+ has ent]$ into =ce = ! ,unit$ ,/ates4 7#d7 ,,lrtap ,,pops ,protocol ,! t]m ,,lrtap ,p,o,ps ,protocol means ! ,protocol on ,p]si/5t ,organic ,pollutants to ! ,,lrtap ,conv5tion1 done at ,a>hus on ,june #bd1 #aiih1 & any subsequ5t am5dm5t to :i* ! ,unit$ ,/ates is a p>ty4 7#e7 ,meet+ ( ! p>ties ,! t]m meet+ ( ! p>ties means-- 7,a7 ! ,conf]5ce ( ! ,p>ties e/abli%$ by & op]at+ "u ,article #ai ( ! ,/ockholm ,conv5tion2 7,b7 ! ,executive ,body e/abli%$ by & op]at+ "u ,article #aj ( ! ,,lrtap ,p,o,ps ,conv5tion2 & 7,c7 ! ,conf]5ce ( ! ,p>ties e/abli%$ by & op]at+ "u ,article #ah ( ! ,rott]dam ,conv5tion4 7#f7 ,,pic *emical ,! t]m ,,pic *emical means any *emical id5tifi$ by notification to ! ,secret>iat ( ! ,rott]dam ,conv5tion by ! ,unit$ ,/ates z bann$ or sev]ely re/rict$ 9 ! ,unit$ ,/ates1 & any *emical li/$ on any ,annex ( ! ,rott]dam ,conv5tion1 if su* li/+ has ent]$ into =ce = ! ,unit$ ,/ates4 7#g7 ,p,o,ps *emical ,! t]m ,p,o,ps *emical means any *emical t is li/$ on any ,annex ( ! ,/ockholm ,conv5tion1 if su* li/+ has ent]$ into =ce = ! ,unit$ ,/ates4 7#h7 ,rott]dam conv5tion ,! t]m ,rott]dam ,conv5tion means ! ,rott]dam ,conv5tion on ! ,prior ,in=m$ ,cons5t ,proc$ure = ,c]ta9 ,haz>d\s ,*emicals & ,pe/icides 9 ,int]national ,trade1 done at ,rott]dam on ,septemb] #aj1 #aiih1 & any subsequ5t am5dm5t to :i* ! ,unit$ ,/ates is a p>ty4 7#i7 ,/ockholm conv5tion ,! t]m ,/ockholm ,conv5tion means ! ,/ockholm ,conv5tion on ,p]si/5t ,organic ,pollutants1 done at ,/ockholm on ,may #bb1 #bjja1 & any subsequ5t am5dm5t to :i* ! ,unit$ ,/ates is a p>ty4 7b7 ,implem5tation ( int]national agreem5ts 7#a7 ,9 g5]al ,! ,adm9i/rator1 9 coop]ation ) appropriate ,f$]al ag5cies1 %all implem5t & support ! implem5tation by ! ,unit$ ,/ates ( ! provisions ( ! ,/ockholm ,conv5tion1 ! ,,lrtap ,p,o,ps ,protocol1 & ! ,rott]dam ,conv5tion t h ent]$ into effect = ! ,unit$ ,/ates4 7#b7 ,prohibitions ,not)/&+ any o!r provision ( law1 no p]son may manufacture1 process1 di/ribute 9 comm]ce1 use1 dispose (1 or take any o!r action ) respect to a ,p,o,ps *emical1 ,,lrtap ,p,o,ps *emical1 or ,,pic *emical 9 a mann] inconsi/5t ) applicable obligations = t *emical "u ! ,/ockholm ,conv5tion1 ,,lrtap ,p,o,ps ,protocol1 or ,rott]dam ,conv5tion4 7#c7 ,public notice & comm5t 7,a7 ,9 g5]al ,! ,adm9i/rator %all provide timely public notice & opportunity to comm5t on a *emical propos$ = li/+ to any ,annex to ! ,/ockholm ,conv5tion1 ! ,,lrtap ,p,o,ps ,protocol1 or ! ,rott]dam ,conv5tion4 7,b7 ,cont5ts ,! ,adm9i/rator %all id5tify 9 ! notice "u subp>agraph 7,a7 any relevant toxicity1 exposure1 & risk in=mation on ! *emical kn[n to ! ,adm9i/rator1 & any dome/ic activities involv+ ! *emical kn[n to ! ,adm9i/rator4 7,c7 ,notice & comm5t 7i7 ,9 g5]al ,any int]e/$ p]son may provide relevant comm5t & in=mation on ! *emical 9 response to ! notice "u subp>agraph 7,a74 7ii7 ,reque/ = in=mation ,! ,adm9i/rator may require ! provision ( relevant in=mation relat$ to a propos$ *emical f any p]son1 z ! ,adm9i/rator det]m9es necess>y to assi/ ! ,unit$ ,/ates 9 ! review4 7iii7 ,public docket ,! ,adm9i/rator %all consid] all comm5ts & in=mation receiv$ "u ?is subp>agraph 9 ! review ( ! proposal & include ! comm5ts & in=mation 9 an e/abli%$ public docket4 7,d7 ,po/-recomm5dation 7i7 ,9 g5]al ,! ,adm9i/rator %all provide timely public notice & opportunity to comm5t aft] a recomm5dation is made to li/ a *emical on any ,annex to ! ,/ockholm ,conv5tion1 ! ,,lrtap ,p,o,ps ,protocol1 or ! ,rott]dam ,conv5tion4 7ii7 ,meet+ ( ! ,p>ties ,! ,adm9i/rator %all provide ! notice "u clause 7i7 9 advance ( ! meet+ ( ! ,p>ties at :i* ! recomm5dation is to be consid]$4 7iii7 ,reque/ = in=mation ,! ,adm9i/rator %all reque/ comm5t & in=mation on all aspects ( ! recomm5dation & may1 if ! ,adm9i/rator det]m9es x to be necess>y to assi/ ! ,unit$ ,/ates 9 ! review1 require ! provision ( relevant in=mation relat$ to a propos$ *emical f any p]son4 7iv7 ,public docket ,! ,adm9i/rator %all consid] all comm5ts & in=mation receiv$ "u ?is subp>agraph 9 ! review ( ! proposal & include ! comm5ts & in=mation 9 an e/abli%$ public docket4 7,e7 ,decisions 7i7 ,9 g5]al ,n lat] ?an #cj days aft] a decision by ! meet+ ( ! p>ties1 ! ,adm9i/rator %all provide timely public notice & opportunity to comm5t on any decision by ! meet+ ( ! p>ties to li/ a *emical on any ,annex to ! ,/ockholm ,conv5tion4 7ii7 ,cont5ts ,! ,adm9i/rator %all provide 9 ! notice "u clause 7i7 a description ( ! am5dm5ts to ! in/rum5ts & id5tify ! *anges to ! dome/ic activities t ! ,adm9i/rator believes1 bas$ on in=mation available to ! ,adm9i/rator1 w\ld be necess>y if ! ,unit$ ,/ates *ose to be b\nd by ! li/+ decision4 7iii7 ,public comm5t ,any int]e/$ p]son may provide relevant comm5t & in=mation 9 response to ! notice "u clause 7i74 7iv7 ,public docket ,! ,adm9i/rator %all consid] all comm5ts & in=mation receiv$ "u ?is subp>agraph 9 ! review ( ! proposal & include ! comm5ts & in=mation 9 an e/abli%$ public docket4 7,f7 ,ratification ,n lat] ?an #cj days aft] ! ,unit$ ,/ates deposits ! in/rum5t ( ratification = ! ,/ockholm ,conv5tion1 ! ,,lrtap ,p,o,ps ,protocol1 or ! ,rott]dam ,conv5tion1 or n lat] ?an #cj days aft] ! li/+ ( any *emical subsequ5tly add$ "u ^? in/rum5ts has ent]$ into =ce = ! ,unit$ ,/ates 7:i*ev] date is e>li]71 ! ,adm9i/rator-- 7i7 %all provide public notice (-- 7,i7 ! *emicals t are subject to ^? in/rum5ts2 & 7,,ii7 any *emical subsequ5tly add$ "u ^? in/rum5ts2 & 7ii7 may specify ! requirem5ts t are applicable = individual *emicals 9 a public notice "u ?is subp>agraph4 7#d7 ,g5]al rulemak+ au?ority ,! ,adm9i/rator may promulgate regulations necess>y to c>ry out ! ,/ockholm ,conv5tion1 ! ,,lrtap ,p,o,ps ,protocol1 or ! ,rott]dam ,conv5tion1 or to ensure compliance ) any obligations "u su* in/rum5ts4 7#e7 ,obligations ,if a *emical is subject to obligations "u m ?an #a ( ! in/rum5ts t includes ! ,/ockholm ,conv5tion1 ! ,,lrtap ,p,o,ps ,protocol1 or ! ,rott]dam ,conv5tion1 ! mo/ /r+5t ( ! obligations %all apply to ensure compliance ) ea* ( ! in/rum5ts4 7c7 ,en=cem5t ,! prohibitions & any o!r requirem5ts ( ?is section %all be en=c$ 9 ! same mann] z f9al rules or ord]s "u section #f4 4 7b7 ,con=m+ am5dm5ts ,! table ( cont5ts = ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfja et seq47 is am5d$-- 7#a7 by /rik+ ! item relat+ to section #b & ins]t+ ! foll[+3 ,sec4 #b4 ,f9d+s1 policy1 & goal4 2 7#b7 by /rik+ ! item relat+ to section #d & ins]t+ ! foll[+3 ,sec4 #d4 ,m9imum data set & te/+ ( *emical sub/ances4 2 7#c7 by /rik+ ! item relat+ to section #f & ins]t+ ! foll[+3 ,sec4 #f4 ,prioritization1 safety /&>d det]m9ation1 & risk managem5t4 2 7#d7 by /rik+ ! items relat+ to sections #bi ?r\gh #ca2 & 7#e7 by add+ aft] ! item relat+ to section #bh ! foll[+3 ,sec4 #bi4 ,*ildr5's ,environm5tal ,heal? ,rese>* ,program4 ,sec4 #cj4 ,r$uction ( animal-bas$ te/+4 ,sec4 #ca4 ,saf] alt]natives & gre5 *emi/ry & eng9e]+4 ,sec4 #cb4 ,coop]ation ) int]national ef=ts4 ,sec4 #cc4 ,reliable in=mation & advice4 ,sec4 #cd4 ,hot spots4 ,sec4 #ce4 ,application ( ?is ,act to ,f$]al ag5cies4 ,sec4 #cf4 ,implem5tation ( ,/ockholm ,conv5tion1 ! ,,lrtap ,pops ,protocol1 & ! ,rott]dam ,conv5tion4 ,sec4 #cg4 ,annual report4 ,sec4 #ch4 ,au?orization ( appropriations4 4