,,ii ,cal5d> ,no4 #fac #aad? ,,congress #b;d ,session ,s4 #ahah ,report ,no4 #aad-cdb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #ba1 #bjae,mr4 ,lank=d 7= himself1 ,ms4 ,heitkamp1 ,ms4 ,ayotte1 & ,mrs4 ,ern/7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ,septemb] #f1 #bjaf,report$ by ,mr4 ,johnson1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to am5d title #e1 ,unit$ ,/ates ,code1 to re=m ! rule mak+ process ( ag5cies4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pr9cipl$ ,rulemak+ ,act ( #bjae4 #b4 ,def9itions ,9 ?is ,act-- 7#a7 ! t]ms ag5cy1 rule1 & rule mak+ h ! mean+s giv5 ^? t]ms 9 section #eea ( title #e1 ,unit$ ,/ates ,code2 & 7#b7 ! t]m regulatory action means any sub/antive action by an ag5cy 7normally publi%$ 9 ! ,f$]al ,regi/]7 t promulgates or is expect$ to lead to ! promulgation ( a f9al regulation1 includ+ notices ( inquiry1 advance notices ( propos$ rule mak+1 & notices ( propos$ rule mak+4 #c4 ,rule mak+ consid]ations ,section #eec ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7f7 ,rule mak+ consid]ations 7#a7 ,9 g5]al ,an ag5cy %all only promulgate a rule "u ?is section t is-- 7,a7 requir$ by law2 7,b7 necess>y to int]pret a law2 or 7,c7 made necess>y by compell+ public ne$1 su* z a mat]ial failure ( ! private m>kets to protect or improve ! heal? & safety ( ! public1 ! environm5t1 or ! wellbe+ ( ! p ( ! ,unit$ ,/ates4 7#b7 ,consid]ations ,be=e promulgat+ a rule "u ?is section1 an ag5cy %all-- 7,a7 id5tify & assess ! significance ( ! problem t ! ag5cy int5ds to address ) ! rule1 includ+1 :]e applicable1 ! failures ( private m>kets or public in/itutions t w>rant new ag5cy action2 7,b7 consid] ! legal au?ority "u :i* ! rule may be propos$1 includ+ :e!r a rule mak+ is requir$ by /atute1 & if s1 :e!r by a specific date1 or :e!r ! ag5cy has discretion to comm5ce a rule mak+2 7,c7 exam9e :e!r exi/+ rules or o!r laws-- 7i7 h creat$ or contribut$ to ! problem id5tifi$ "u subp>agraph 7,a72 & 7ii7 %\ld be modifi$ to a*ieve ! int5d$ regulatory objective m effectively2 7,d7 id5tify & assess available alt]natives to direct regulation1 includ+ by provid+-- 7i7 economic inc5tives to enc\rage ! desir$ behavior1 su* z us] fees or m>ketable p]mits2 or 7ii7 in=mation ^u :i* *oices may be made by ! public2 7,e7 consid]1 to ! ext5t reasonable1 ! degree & nature ( ! risks pos$ by v>i\s sub/ances or activities )9 ! jurisdiction ( ! ag5cy2 7,f7 if aft] det]m9+ t a rule is ! be/ available me?od ( a*iev+ ! regulatory objective1 design ! rule 9 ! mo/ co/-effective mann] to a*ieve ! regulatory objective2 7,g7 9 c>ry+ out subp>agraph 7,f71 consid]-- 7i7 inc5tives = innovation1 consi/5cy1 pr$ictability1 flexibility1 di/ributive impacts1 & equity2 & 7ii7 ! co/s ( en=cem5t & compliance to ! ,f$]al ,gov]nm5t1 regulat$ entities1 & ! public2 7,h7 assess ! co/s & ! b5efits ( ! int5d$ rule &1 recogniz+ t "s co/s & b5efits 7includ+ quantifable & qualitative measures7 are difficult to quantify-- 7i7 propose or adopt a rule only ^u a reason$ det]m9ation t ! b5efits ( ! int5d$ rule ju/ify ! co/s ( ! rule2 & 7ii7 select approa*es t maximize net b5efits1 unless a /atute requires ano!r regulatory approa*2 7,i7 base decisions on ! be/ reasonably obta9able sci5tific1 te*nical1 economic1 & o!r in=mation conc]n+ ! ne$ =1 & consequ5ces (1 ! int5d$ rule2 7,j7 id5tify & assess alt]native =ms ( regulation &1 to ! ext5t feasible1 specify p]=mance objectives1 & n ! behavior or mann] ( compliance t regulat$ entities are requir$ to adopt2 7,k7 seek views ( appropriate ,/ate1 local1 & tribal (ficials be=e impos+ regulatory requirem5ts t may significantly or uniquely affect ^? gov]nm5tal entities2 7,l7 assess ! effects ( rules on ,/ate1 local1 & tribal gov]nm5ts1 includ+ specifically ! availability ( res\rces to c>ry out ^? m&ates1 & seek to m9imize ^? burd5s t uniquely or significantly affect ^? gov]nm5tal entities1 consi/5t ) a*iev+ ! regulatory objective ( ! ag5cy2 7,m7 z appropriate1 seek to h>monize ag5cy action ) relat$ ,/ate1 local1 & tribal regulatory & o!r gov]nm5tal functions2 7,n7 avoid ! promulgation ( a rule t is inconsi/5t1 incompatible1 or duplicative ) o!r rules ( ! ag5cy or ^? ( o!r ag5cies2 7,o7 tailor ! rule-- 7i7 to impose ! lea/ burd5 on society1 includ+ individuals1 bus9esses ( diff]+ sizes1 & o!r entities1 includ+ small communities & gov]nm5tal entities2 & 7ii7 9 a mann] t is consi/5t ) obta9+ ! regulatory objective1 tak+ into acc\nt1 & to ! ext5t practicable1 ! co/s ( cumulative rules2 & 7,p7 9 ord] to m9imize ! pot5tial = unc]ta9ty & litigation aris+ f su* unc]ta9ty1 draft ! rule 9 a mann] t is simple & easy to und]/&4 4 #d4 ,public p>ticipation 7a7 ,9 g5]al ,to promote an op5 ex*ange ) ! public1 ea* ag5cy %all1 consi/5t ) section #eec ( title #e1 ,unit$ ,/ates ,code1 & o!r applicable requirem5ts1 issue rules ?r\gh a process t involves public p>ticipation1 includ+-- 7#a7 provid+ ! public ) an opportunity to p>ticipate 9 ! regulatory process2 & 7#b7 to ! ext5t feasible-- 7,a7 af=d+ ! public a mean+ful opportunity to submit comm5ts ?r\gh ! ,int]net on any propos$ rule = a p]iod ( n less ?an #fj days2 7,b7 provid+1 = bo? propos$ & f9al rules1 timely onl9e access to ! rule mak+ docket ( ! ag5cy on an easily accessible ,f$]al website1 includ+ relevant sci5tific & te*nical f9d+s1 9 an op51 se>*able1 & d[nloadable =mat2 & 7,c7 provid+ an opportunity = public comm5t on all p]t95t p>ts ( ! propos$ rule mak+ docket ( ! ag5cy1 includ+ relevant sci5tific & te*nical f9d+s4 7b7 ,comm5ts f affect$ p>ties ,be=e issu+ a notice ( propos$ rule mak+1 ea* ag5cy %all1 :5 feasible & appropriate1 seek ! views ( ^? :o are likely to be affect$ by ! rule1 includ+ ^? :o are likely to b5efit f & ^? :o are pot5tially subject to ! rule4 #e4 ,integration & innovation ,9 develop+ regulatory actions & id5tify+ appropriate approa*es1 ea* ag5cy %all-- 7#a7 attempt to promote coord9ation1 simplification1 & h>monization2 & 7#b7 seek to id5tify1 z appropriate1 means to a*ieve regulatory goals t are design$ to promote innovation4 #f4 ,flexible approa*es ,:]e relevant1 feasible1 & consi/5t ) regulatory objectives1 & to ! ext5t p]mitt$ by law1 ea* ag5cy %all id5tify & consid] regulatory approa*es t-- 7#a7 r$uce burd5s & ma9ta9 flexibility & fre$om ( *oice = ! public2 7#b7 include w>n+s1 appropriate default rules1 & disclosure requirem5ts2 & 7#c7 provide in=mation to ! public 9 a =m t is cle> & intelligible4 #g4 ,sci5ce ,ea* ag5cy %all ensure ! objectivity ( any sci5tific & te*nological in=mation & processes us$ to support ea* regulatory action ( ! ag5cy4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pr9cipl$ ,rulemak+ ,act ( #bjae4 #b4 ,def9itions ,9 ?is ,act-- 7#a7 ! t]ms ag5cy1 rule1 & rule mak+ h ! mean+s giv5 ^? t]ms 9 section #eea ( title #e1 ,unit$ ,/ates ,code2 & 7#b7 ! t]m regulatory action-- 7,a7 means any sub/antive action by an ag5cy 7normally publi%$ 9 ! ,f$]al ,regi/]7 t promulgates or is expect$ to lead to ! promulgation ( a f9al regulation1 includ+ notices ( inquiry1 advance notices ( propos$ rule mak+1 & notices ( propos$ rule mak+2 & 7,b7 does n include an action by an ag5cy involv+-- 7i7 a milit>y or =eign affairs function ( ! ,unit$ ,/ates2 or 7ii7 a matt] relat+ to ag5cy managem5t or p]sonnel or to public prop]ty1 loans1 grants1 b5efits1 or contracts4 #c4 ,rule mak+ consid]ations ,section #eec ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7f7 ,rule mak+ consid]ations 7#a7 ,9 g5]al ,an ag5cy %all only promulgate a rule "u ?is section t is-- 7,a7 requir$ by law2 7,b7 necess>y to int]pret a law2 or 7,c7 z p]mitt$ by law1 made necess>y by public ne$1 to protect or improve ! heal? & safety ( ! public1 ! environm5t1 or ! wellbe+ ( ! p ( ! ,unit$ ,/ates4 7#b7 ,consid]ations ,be=e promulgat+ a rule "u ?is section1 an ag5cy %all-- 7,a7 id5tify & assess ! significance ( ! problem t ! ag5cy int5ds to address ) ! rule2 7,b7 consid] ! legal au?ority "u :i* ! rule may be propos$1 includ+ :e!r a rule mak+ is requir$ by /atute1 & if s1 :e!r by a specific date1 or :e!r ! ag5cy has discretion to comm5ce a rule mak+2 7,c7 :]e practicable1 exam9e :e!r exi/+ rules or o!r laws1 includ+ ! cumulative effect ( exi/+ rules or o!r laws-- 7i7 h creat$ or contribut$ to ! problem id5tifi$ "u subp>agraph 7,a72 & 7ii7 %\ld be modifi$ to a*ieve ! int5d$ regulatory objective m effectively2 7,d7 z p]mitt$ by /atute1 id5tify & assess available alt]natives to direct regulation1 includ+ by provid+-- 7i7 economic inc5tives to enc\rage ! desir$ behavior1 su* z us] fees or m>ketable p]mits2 or 7ii7 in=mation to ! public 9 a =m t is cle> & intelligible2 7,e7 consid]1 to ! ext5t reasonable1 ! degree & nature ( ! risks pos$ by v>i\s sub/ances or activities )9 ! jurisdiction ( ! ag5cy2 7,f7 aft] det]m9+ t a rule is ! be/ available me?od ( a*iev+ ! regulatory objective-- 7i7 assess ! co/s & b5efits ( ! int5d$ rule &1 recogniz+ t "s co/s & b5efits 7includ+ quantifiable & qualitative measures7 are difficult to quantify1 design ! rule to maximize net b5efits :ile ju/ify+ ! co/s1 unless a /atute requires ano!r regulatory approa*2 & 7ii7 z p]mitt$ by /atute-- 7,i7 consid]1 :5 develop+ ! rule-- 7aa7 inc5tives = innovation1 consi/5cy1 pr$ictability1 flexibility1 di/ributive impacts1 & equity on ! regulat$ entities & ! public2 & 7bb7 ! co/ ( en=cem5t & compliance to ! ,f$]al ,gov]nm5t1 regulat$ entities1 & ! public2 & 7,,ii7 select approa*es t r$uce burd5s & ma9ta9 flexibility & fre$om ( *oice = regulat$ entities & ! public2 7,g7 base decisions on ! be/ reasonably obta9able & publically accessible sci5tific1 te*nical1 economic1 & o!r in=mation conc]n+ ! ne$ =1 & consequ5ces (1 ! int5d$ rule2 7,h7 id5tify & assess alt]native =ms ( regulation &1 to ! ext5t feasible1 specify p]=mance objectives1 & n ! behavior or mann] ( compliance t regulat$ entities are requir$ to adopt2 7,i7 seek views ( appropriate ,/ate1 local1 & tribal (ficials be=e impos+ regulatory requirem5ts t may significantly or uniquely affect ^? gov]nm5tal entities2 7,j7 assess ! effects ( rules on ,/ate1 local1 & tribal gov]nm5ts & ! private sector1 includ+ specifically ! availability ( res\rces to c>ry out ^? m&ates1 & seek to m9imize ^? burd5s t uniquely or significantly affect ^? gov]nm5tal entities1 consi/5t ) a*iev+ ! regulatory objective ( ! ag5cy2 7,k7 z appropriate1 seek to h>monize ag5cy action ) relat$ ,/ate1 local1 & tribal regulatory & o!r gov]nm5tal functions2 7,l7 avoid ! promulgation ( a rule t is inconsi/5t1 incompatible1 or duplicative ) o!r rules ( ! ag5cy or ^? ( o!r ag5cies2 7,m7 tailor ! rule-- 7i7 to maximize b5efits :ile impos+ ! lea/ possible burd5 on society1 includ+ individuals1 bus9esses ( diff]+ sizes1 & o!r entities1 includ+ small communities & gov]nm5tal entities2 & 7ii7 9 a mann] t is consi/5t ) obta9+ ! regulatory objective1 tak+ into acc\nt1 & to ! greate/ ext5t practicable1 ! co/s ( cumulative rules2 & 7,n7 9 ord] to m9imize ! pot5tial = unc]ta9ty & litigation aris+ f su* unc]ta9ty-- 7i7 draft ! rule 9 a mann] t is simple & easy to und]/&2 & 7ii7 include in=mation to assi/ ) compliance ) ! rule1 su* z w>n+s1 appropriate default rules1 & disclosure requirem5ts4 7#c7 ,exceptions ,?is subsection %all n apply-- 7,a7 to int]pretative rules1 g5]al /atem5ts ( policy1 or rules ( ag5cy organization1 proc$ures1 or practice2 7,b7 if ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs waives ! requirem5ts ( ?is subsection = good cause2 or 7,c7 if ! /atute on :i* a propos$ rule is bas$ specifically exempts a rule f any ( ! proc$ures "u ?is subsection4 7#d7 ,judicial review 7,a7 ,9 g5]al ,compliance by an ag5cy ) ! provisions ( ?is subsection %all be subject to judicial review only-- 7i7 9 connection ) review ( f9al ag5cy action2 & 7ii7 9 accordance ) ?is p>agraph4 7,b7 ,det]m9ations by ,adm9i/rator ,any det]m9ation1 action1 or inaction ( ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs "u ?is subsection %all n be subject to judicial review4 7,c7 ,review ) f9al rule ,compliance by an ag5cy ) ! provisions ( ?is subsection %all only be subject to judicial review 9 connection ) review ( ! f9al rule to :i* an analysis1 assessm5t1 or o!r consid]ation "u p>agraph 7#b7 applies4 7,d7 ,rule mak+ record ,ea* consid]ation by an ag5cy "u p>agraph 7#b7 %all be-- 7i7 includ$ z "p ( ! rule mak+ record = ! rule2 & 7ii7 to ! ext5t relevant1 consid]$ by a c\rt only 9 det]m9+ :e!r1 "u ! /atute grant+ ! rule mak+ au?ority to ! ag5cy1 ! f9al rule is-- 7,i7 arbitr>y1 caprici\s1 or an abuse ( discretion2 or 7,,ii7 unsupport$ by sub/antial evid5ce :]e ! /&>d is o!rwise provid$ by law4 7,e7 ,set aside ,if an ag5cy fails to comply ) ! requirem5ts "u p>agraph 7#b71 a c\rt may1 giv+ due acc\nt to prejudicial error1 hold unlawful & set aside ! ag5cy action4 4 #d4 ,public p>ticipation 7a7 ,9 g5]al ,to promote an op5 ex*ange ) ! public1 ea* ag5cy %all1 consi/5t ) section #eec ( title #e1 ,unit$ ,/ates ,code1 & o!r applicable requirem5ts1 issue rules ?r\gh a process t involves public p>ticipation1 includ+-- 7#a7 provid+ ! public ) a mean+ful opportunity to p>ticipate 9 ! regulatory process2 & 7#b7 to ! greate/ ext5t feasible-- 7,a7 af=d+ ! public a mean+ful opportunity to submit comm5ts ?r\gh ! ,int]net on any propos$ rule = a p]iod ( n less ?an #fj days2 7,b7 provid+1 = bo? propos$ & f9al rules1 timely onl9e access to ! rule mak+ docket ( ! ag5cy on an easily accessible ,f$]al website1 includ+ relevant sci5tific & te*nical f9d+s1 9 an op51 se>*able1 & d[nloadable =mat2 & 7,c7 provid+ an opportunity = public comm5t on all p]t95t p>ts ( ! propos$ rule mak+ docket ( ! ag5cy1 includ+ relevant sci5tific & te*nical f9d+s4 7b7 ,comm5ts f affect$ p>ties ,be=e issu+ a notice ( propos$ rule mak+1 ea* ag5cy %all1 :5 feasible & appropriate1 seek ! views ( ^? :o are likely to be affect$ by ! rule1 includ+ ^? :o are likely to b5efit f & ^? :o are pot5tially subject to ! rule4 #e4 ,integration & innovation ,9 develop+ regulatory actions & id5tify+ appropriate approa*es1 ea* ag5cy %all-- 7#a7 attempt to promote coord9ation1 simplification1 & h>monization2 & 7#b7 seek to id5tify1 z appropriate1 means to a*ieve regulatory goals t are design$ to promote innovation4 #f4 ,sci5ce ,:5 issu+ a rule "u section #eec1 ea* ag5cy %all ensure t any sci5tific & te*nological in=mation & processes1 includ+ models1 us$ to support any regulatory action ( ! ag5cy is ! be/ available1 by tak+ into consid]ation :e!r ! sci5tific & te*nological in=mation & processes us$ are objective1 pe]-review$1 reproducible1 & publically available4 ,septemb] #f1 #bjaf,report$ ) an am5dm5t