,,ii #aac? ,,congress #a/ ,session ,s4 #ajbi ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bc1 #bjac ,mr4 ,portman 7= himself1 ,mr4 ,pryor1 ,ms4 ,coll9s1 ,mr4 ,nelson1 ,mr4 ,cornyn1 ,mr4 ,man*91 ,ms4 ,ayotte1 ,mr4 ,k+1 & ,mr4 ,johanns7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ,a ,,bill ,to re=m ! process by :i* ,f$]al ag5cies analyze & =mulate new regulations & guidance docum5ts4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,regulatory ,acc\ntability ,act ( #bjac4 #b4 ,def9itions ,section #eea ( title #e1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 p>agraph 7#ac71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#ad71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7#ae7 guidance means an ag5cy /atem5t ( g5]al applicability1 o!r ?an a rule1 t is n int5d$ to h ! =ce & effect ( law b t sets =? a policy on a /atutory1 regulatory1 or te*nical issue or an int]pretation ( a /atutory or regulatory issue2 7#af7 high-impact rule means any rule t ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs det]m9es is likely to impose a co/ on ! economy 9 any #a ye> ( #a1jjj1jjj1jjj or m1 adju/$ annually = inflation2 7#ag7 major rule means any rule t ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs det]m9es is likely to impose-- 7,a7 a co/ on ! economy 9 any #a ye> ( #ajj1jjj1jjj or m1 adju/$ annually = inflation2 7,b7 a major increase 9 co/s or prices = consum]s1 individual indu/ries1 ,f$]al1 ,/ate1 local1 or tribal gov]nm5t ag5cies1 or geographic regions2 or 7,c7 significant adv]se effects on competition1 employm5t1 inve/m5t1 productivity1 innovation1 or on ! ability ( ,unit$ ,/ates-bas$ ent]prises to compete ) =eign-bas$ ent]prises 9 dome/ic & export m>kets2 7#ah7 major guidance means guidance t ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs f9ds is likely to lead to-- 7,a7 a co/ on ! economy 9 any #a ye> ( #ajj1jjj1jjj or m1 adju/$ annually = inflation2 7,b7 a major increase 9 co/s or prices = consum]s1 individual indu/ries1 ,f$]al1 ,/ate1 local or tribal gov]nm5t ag5cies1 or geographic regions2 or 7,c7 significant adv]se effects on competition1 employm5t1 inve/m5t1 productivity1 innovation1 or on ! ability ( ,unit$ ,/ates-bas$ ent]prises to compete ) =eign-bas$ ent]prises 9 dome/ic & export m>kets2 & 7#ai7 ,(fice ( ,in=mation & ,regulatory ,affairs means ! (fice e/abli%$ "u section #cejc ( title #dd & any successor to t (fice4 4 #c4 ,rulemak+ ,section #eec ( title #e1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ 7a7 ,?is section applies & ins]t+ 7a7 ,applicability4--,?is section applies2 & 7#b7 by /rik+ subsections 7b7 ?r\gh 7e7 & ins]t+ ! foll[+3 7b7 ,rulemak+ consid]ations ,9 a rulemak+1 an ag5cy %all consid]1 9 addition to o!r applicable consid]ations1 ! foll[+3 7#a7 ,! legal au?ority "u :i* a rule may be propos$1 includ+ :e!r rulemak+ is requir$ by /atute or is )9 ! discretion ( ! ag5cy4 7#b7 ,! nature & significance ( ! problem ! ag5cy int5ds to address ) a rule4 7#c7 ,:e!r exi/+ ,f$]al laws or rules h creat$ or contribut$ to ! problem ! ag5cy may address ) a rule &1 if s1 :e!r ^? ,f$]al laws or rules c\ld be am5d$ or resc9d$ to address ! problem 9 :ole or 9 "p4 7#d7 ,a reasonable numb] ( alt]natives = a new rule1 includ+ any sub/antial alt]natives or o!r responses id5tifi$ by int]e/$ p]sons4 7#e7 ,= any major rule or high-impact rule1 ! pot5tial co/s & b5efits associat$ ) pot5tial alt]native rules & o!r responses consid]$ "u p>agraph 7#d71 includ+ an analysis (-- 7,a7 ! nature & degree ( risks address$ by ! rule & ! c\nt]vail+ risks t might be pos$ by ag5cy action2 7,b7 direct1 indirect1 & cumulative co/s & b5efits2 & 7,c7 e/imat$ impacts on jobs1 competitiv5ess1 & productivity4 7c7 ,initiation ( rulemak+ 7#a7 ,notice = major & high-impact rules ,:5 an ag5cy det]m9es to initiate a rulemak+ t may result 9 a major rule or high-impact rule1 ! ag5cy %all-- 7,a7 e/abli% an electronic docket = t rulemak+1 :i* may h a physical c\nt]p>t2 & 7,b7 publi% a notice ( initiation ( rulemak+ 9 ! ,f$]al ,regi/]1 :i* %all-- 7i7 briefly describe ! subject1 ! problem to be solv$1 & ! objectives ( ! rule2 7ii7 ref]5ce ! legal au?ority "u :i* ! rule w\ld be propos$2 7iii7 invite int]e/$ p]sons to propose alt]natives = accompli%+ ! objectives ( ! ag5cy 9 ! mo/ effective mann] & ) ! l[e/ co/2 & 7iv7 indicate h[ int]e/$ p]sons may submit writt5 mat]ial = ! docket4 7#b7 ,accessibility ,all in=mation provid$ to ! ag5cy "u p>agraph 7#a7 %all be promptly plac$ 9 ! docket & made accessible to ! public4 7d7 ,notice ( propos$ rulemak+ 7#a7 ,9 g5]al ,if an ag5cy det]m9es t ! objectives ( ! ag5cy require ! ag5cy to issue a rule1 ! ag5cy %all notify ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs & publi% a notice ( propos$ rulemak+ 9 ! ,f$]al ,regi/]1 :i* %all include-- 7,a7 a /atem5t ( ! "t1 place1 & nature ( any public rulemak+ proce$+s2 7,b7 ref]5ce to ! legal au?ority "u :i* ! rule is propos$2 7,c7 ! text ( ! propos$ rule2 7,d7 a summ>y ( in=mation kn[n to ! ag5cy conc]n+ ! consid]ations specifi$ 9 subsection 7b72 & 7,e7 = any major rule or high impact-rule-- 7i7 a reason$ prelim9>y det]m9ation t ! b5efits ( ! propos$ rule ju/ify ! co/s ( ! propos$ rule2 & 7ii7 a discussion (-- 7,i7 ! co/s & b5efits ( alt]natives consid]$ by ! ag5cy "u subsection 7b71 z det]m9$ by ! ag5cy at its discretion or provid$ "u subsection 7c7 by a propon5t ( an alt]native2 7,,ii7 :e!r ^? alt]natives meet relevant /atutory objectives2 & 7,,iii7 ! reasons :y ! ag5cy did n propose any ( ^? alt]natives4 7#b7 ,accessibility ,n lat] ?an ! date ( publication ( ! notice ( propos$ rulemak+ by an ag5cy "u p>agraph 7#a71 all data1 /udies1 models1 & o!r in=mation consid]$ by ! ag5cy1 & actions by ! ag5cy to obta9 in=mation1 9 connection ) ! det]m9ation ( ! ag5cy to propose ! rule1 %all be plac$ 9 ! docket = ! propos$ rule & made accessible to ! public4 7#c7 ,public comm5t 7,a7 ,aft] publi%+ a notice ( propos$ rulemak+1 ! ag5cy %all provide int]e/$ p]sons an opportunity to p>ticipate 9 ! rulemak+ ?r\gh ! submission ( writt5 mat]ial1 data1 views1 or argum5ts ) or )\t opportunity = oral pres5tation1 except t-- 7i7 if a public he>+ is conv5$ "u subsection 7e71 reasonable opportunity = oral pres5tation %all be provid$ at ! public he>+ "u ! requirem5ts ( subsection 7e72 & 7ii7 :51 o!r ?an "u subsection 7e71 a rule is requir$ by /atute or at ! discretion ( ! ag5cy to be made on ! record aft] opportunity = an ag5cy he>+1 sections #eef & #eeg %all apply1 & ! petition proc$ures ( subsection 7e7 %all n apply4 7,b7 ,! ag5cy %all provide n less ?an #fj days1 or #ij days 9 ! case ( a propos$ major rule or propos$ high-impact rule1 = int]e/$ p]sons to submit writt5 mat]ial1 data1 views1 or argum5ts4 7#d7 ,expiration ( notice 7,a7 ,except z provid$ 9 subp>agraph 7,b71 a notice ( propos$ rulemak+ %all1 #b ye>s aft] ! date on :i* ! notice is publi%$ 9 ! ,f$]al ,regi/]1 be consid]$ z expir$ & may n be us$ to satisfy ! requirem5ts ( subsection 7d74 7,b7 ,an ag5cy may1 at ! sole discretion ( ! ag5cy1 ext5d ! expiration ( a notice ( propos$ rulemak+ "u subp>agraph 7,a7 = a #a ye> p]iod by publi%+ a supplem5tal notice 9 ! ,f$]al ,regi/] expla9+ :y ! ag5cy requires additional "t to complete ! rulemak+4 7e7 ,public he>+ = high-,impact rules 7#a7 ,petition = public he>+ 7,a7 7i7 ,be=e ! close ( ! comm5t p]iod = any propos$ high-impact rule1 any int]e/$ p]son may petition ! ag5cy to hold a public he>+ 9 accordance ) ?is subsection4 7ii7 ,n lat] ?an #cj days aft] receipt ( a petition made pursuant to clause 7i71 ! ag5cy %all grant ! petition if ! petition %[s t-- 7,i7 ! propos$ rule is bas$ on conclusions ) respect to "o or m specific sci5tific1 te*nical1 economic or o!r complex factual issues t are g5u9ely disput$2 & 7,,ii7 ! resolution ( ^? disput$ factual issues w\ld likely h an effect on ! co/s & b5efits ( ! propos$ rule4 7,b7 ,if ! ag5cy d5ies a petition "u ?is subsection 9 :ole or 9 "p1 x %all include 9 ! rulemak+ record an explanation = ! d5ial suffici5t = judicial review1 includ+-- 7i7 f9d+s by ! ag5cy t !re is no g5u9e dispute z to ! factual issues rais$ by ! petition2 or 7ii7 a reason$ det]m9ation by ! ag5cy t ! factual issues rais$ by ! petition1 ev5 if subject to g5u9e dispute1 w n h an effect on ! co/s & b5efits ( ! propos$ rule4 7#b7 ,notice ( he>+ ,n lat] ?an #de days be=e any he>+ held "u ?is subsection1 ! ag5cy %all publi% 9 ! ,f$]al ,regi/] a notice specify+ ! propos$ rule to be consid]$ at ! he>+ & ! factual issues to be consid]$ at ! he>+4 7#c7 ,he>+ proc$ure 7,a7 ,a he>+ held "u ?is subsection %all be limit$ to ! specific factual issues rais$ 9 ! petition or petitions grant$ 9 :ole or 9 "p "u p>agraph 7#a7 & any o!r factual issues ! resolution ( :i* ! ag5cy1 9 its discretion1 det]m9es w advance its consid]ation ( ! propos$ rule4 7,b7 7i7 ,except z o!rwise provid$ by /atute1 ! propon5t ( ! rule has ! burd5 ( pro( 9 a he>+ held "u ?is subsection4 ,any docum5t>y or oral evid5ce may be receiv$1 b ! ag5cy z a matt] ( policy %all provide = ! exclusion ( immat]ial or unduly repetiti\s evid5ce4 7ii7 ,to gov]n he>+s held "u ?is subsection1 ea* ag5cy %all adopt rules t provide =-- 7,i7 ! appo9tm5t ( an ag5cy (ficial or adm9i/rative law judge to preside at ! he>+2 7,,ii7 ! pres5tation by int]e/$ p>ties ( relevant docum5t>y or oral evid5ce1 unless ! evid5ce is immat]ial or unduly repetiti\s2 7,,iii7 a reasonable & adequate opportunity = cross-exam9ation by int]e/$ p>ties conc]n+ g5u9ely disput$ factual issues rais$ by ! petition1 provid$ t 9 ! case ( multiple int]e/$ p>ties ) ! same or simil> int]e/s1 ! ag5cy may require ! use ( common c\nsel :]e ! common c\nsel may adequately repres5t ! int]e/s t w be significantly affect$ by ! propos$ rule2 & 7,,iv7 ! provision ( fees & co/s "u ! circum/ances describ$ 9 section #f7;c77#d7 ( ! ,toxic ,sub/ances ,control ,act 7#ae ,u4,s4,c4 #bfje7;c77#d774 7,c7 ,! transcript ( te/imony & exhibits1 toge!r ) all pap]s & reque/s fil$ 9 ! he>+1 %all con/itute ! exclusive record = decision ( ! factual issues address$ 9 a he>+ held "u ?is subsection4 7#d7 ,petition = public he>+ = major rules ,9 ! case ( any major rule1 any int]e/$ p]son may petition = a he>+ "u ?is subsection on ! gr\nds & )9 ! "t limitation set =? 9 p>agraph 7#a74 ,! ag5cy may d5y ! petition if ! ag5cy reasonably det]m9es t a he>+ w\ld n advance ! consid]ation ( ! propos$ rule by ! ag5cy or w\ld1 9 light ( ! ne$ = ag5cy action1 unreasonably delay completion ( ! rulemak+4 ,! petition & ! decision ( ! ag5cy ) respect to ! petition %all be includ$ 9 ! rulemak+ record4 7#e7 ,judicial review 7,a7 ,failure to petition = a he>+ "u ?is subsection %all n preclude judicial review ( any claim t c\ld h be5 rais$ 9 ! he>+ petition or at ! he>+4 7,b7 ,!re %all be no judicial review ( ! disposition ( a petition by an ag5cy "u ?is subsection until judicial review ( ! f9al action ( ! ag5cy4 7f7 ,f9al rules 7#a7 ,co/ ( major or high-impact rule 7,a7 ,except z provid$ 9 subp>agraph 7,b71 9 a rulemak+ = a major rule or high-impact rule1 ! ag5cy %all adopt ! lea/ co/ly rule consid]$ dur+ ! rulemak+ t meets relevant /atutory objectives4 7,b7 ,! ag5cy may adopt a rule t is m co/ly ?an ! lea/ co/ly alt]native t w\ld a*ieve ! relevant /atutory objectives only if-- 7i7 ! additional b5efits ( ! m co/ly rule ju/ify its additional co/s2 & 7ii7 ! ag5cy expla9s :y ! ag5cy adopt$ a rule t is m co/ly ?an ! lea/ co/ly alt]native1 bas$ on int]e/s t are )9 ! scope ( ! /atutory provision au?oriz+ ! rule4 7#b7 ,publication ( notice ( f9al rulemak+ ,:5 ! ag5cy adopts a f9al rule1 ! ag5cy %all publi% a notice ( f9al rulemak+ 9 ! ,f$]al ,regi/]1 :i* %all include-- 7,a7 a concise1 g5]al /atem5t ( ! basis & purpose ( ! rule2 7,b7 a reason$ det]m9ation by ! ag5cy reg>d+ ! consid]ations specifi$ 9 subsection 7c72 7,c7 9 a rulemak+ = a major rule or high-impact rule1 a reason$ det]m9ation by ! ag5cy t ! b5efits ( ! rule advance ! relevant /atutory objectives & ju/ify ! co/s ( ! rule2 7,d7 9 a rulemak+ = a major rule or high-impact rule1 a reason$ det]m9ation by ! ag5cy t-- 7i7 no alt]native consid]$ w\ld a*ieve ! relevant /atutory objectives at a l[] co/ ?an ! rule2 or 7ii7 ! adoption by ! ag5cy ( a m co/ly rule complies ) p>agraph 7#b77;,b72 & 7,e7 a response to ea* significant issue rais$ 9 ! comm5ts on ! propos$ rule4 7#c7 ,in=mation quality ,if an ag5cy rulemak+ re/s ^u sci5tific1 te*nical1 or economic in=mation1 ! ag5cy %all adopt a rule only on ! basis ( ! be/ available sci5tific1 te*nical1 or economic in=mation4 7#d7 ,accessibility ,n lat] ?an ! date ( publication ( ! rule1 all data1 /udies1 models1 & o!r in=mation consid]$ by ! ag5cy1 & actions by ! ag5cy to obta9 in=mation 9 connection ) its adoption ( ! rule1 %all be plac$ 9 ! docket = ! rule & made accessible to ! public4 7#e7 ,rules adopt$ at ! end ( a ,presid5tial adm9i/ration 7,a7 ,dur+ ! #fj-;day p]iod beg9n+ on a transitional inauguration day 7z def9$ 9 section #ccdi;a71 ) respect to any f9al rule t _h be5 plac$ on file = public inspection by ! ,(fice ( ! ,f$]al ,regi/] or publi%$ 9 ! ,f$]al ,regi/] z ( ! date ( ! inauguration1 b :i* _h n yet become effective by ! date ( ! inauguration1 ! ag5cy issu+ ! rule may1 by ord]1 delay ! effective date ( ! rule = n m ?an #ij days = ! purpose ( obta9+ public comm5t on :e!r ! rule %\ld be am5d$ or resc9d$ or its effective date fur!r delay$4 7,b7 ,if an ag5cy delays ! effective date ( a rule "u subp>agraph 7,a71 ! ag5cy %all give ! public n less ?an #cj days to submit comm5ts4 7g7 ,applicability ( ?is section 7#a7 ,9 g5]al ,except z o!rwise provid$ by law1 ?is section does n apply to guidance or rules ( ag5cy organization1 proc$ure1 or practice4 7#b7 ,adoption ( int]im rules 7,a7 ,if an ag5cy = good cause f9ds1 & incorporates ! f9d+ & a brief /atem5t ( reasons = ! f9d+ 9 ! rule issu$1 t compliance ) subsection 7c71 7d71 or 7e7 or requirem5ts to r5d] f9al det]m9ations "u subsection 7f7 be=e ! issuance ( an int]im rule is unnecess>y1 su* subsections & requirem5ts "u subsection 7f7 %all n apply & ! ag5cy may issue a f9al rule4 7,b7 ,if an ag5cy = good cause f9ds1 & incorporates ! f9d+ & a brief /atem5t ( reasons = ! f9d+ 9 ! rule issu$1 t compliance ) subsection 7c71 7d71 or 7e7 or requirem5ts to r5d] f9al det]m9ations "u subsection 7f7 be=e ! issuance ( an int]im rule is impracticable or contr>y to ! public int]e/1 su* subsections & requirem5ts "u subsection 7f7 %all n apply to ! adoption ( an int]im rule by ! ag5cy4 7,c7 ,if1 foll[+ compliance ) subp>agraph 7,b71 an ag5cy adopts an int]im rule1 ! ag5cy %all comm5ce proce$+s t fully comply ) subsections 7c7 ?r\gh 7f7 imm$iately ^u publication ( ! int]im rule4 ,n less ?an #bgj days f publication ( ! int]im rule1 or #ah mon?s 9 ! case ( a major rule or high-impact rule1 ! ag5cy %all complete rulemak+ 9 accordance ) subsections 7c7 ?r\gh 7f7 & take f9al action to adopt a f9al rule or resc9d ! int]im rule4 ,if ! ag5cy fails to take timely f9al action "u ?is subp>agraph1 ! int]im rule %all cease to h ! effect ( law4 7h7 ,date ( publication ( rule ,a rule %all be publi%$ n less ?an #cj days be=e ! effective date ( ! rule1 except-- 7#a7 = a rule t grants or recognizes an exemption or relieves a re/riction2 7#b7 = guidance2 or 7#c7 z o!rwise provid$ by an ag5cy = good cause & z publi%$ ) ! rule4 7i7 ,"r ,to petition & review ( rules 7#a7 ,ea* ag5cy %all give int]e/$ p]sons ! "r to petition = ! issuance1 am5dm5t1 or repeal ( a rule4 7#b7 ,ea* ag5cy %all1 on a cont9u+ basis1 invite int]e/$ p]sons to submit1 by electronic means1 sugge/ions = rules t w>rant retrospective review & possible modification or repeal4 7j7 ,rulemak+ guidel9es 7#a7 ,assessm5t ( rules 7,a7 ,! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs 79 ?is subsection ref]r$ to z ! ,adm9i/rator7 %all e/abli% guidel9es = ! assessm5t1 includ+ quantitative & qualitative assessm5t1 (-- 7i7 ! co/s & b5efits ( propos$ & f9al rules2 7ii7 o!r economic issues t are relevant to rulemak+ "u ?is section or o!r sections ( ?is title2 & 7iii7 risk assessm5ts t are relevant to rulemak+ "u ?is section & o!r sections ( ?is title4 7,b7 ,! rigor ( co/-b5efit analysis requir$ by ! guidel9es e/abli%$ "u subp>agraph 7,a7 %all be comm5surate1 z det]m9$ by ! ,adm9i/rator1 ) ! economic impact ( ! rule4 ,guidel9es = risk assessm5t %all include crit]ia = select+ /udies & models1 evaluat+ & weigh+ evid5ce1 & conduct+ pe] reviews4 7,c7 ,! ,adm9i/rator %all regul>ly update guidel9es e/abli%$ "u subp>agraph 7,a7 to enable ag5cies to use ! be/ available te*niques to quantify & evaluate pres5t & future b5efits1 co/s1 o!r economic issues1 & risks z objectively & accurately z practicable4 7#b7 ,simplification ( rules ,! ,adm9i/rator may issue guidel9es to promote coord9ation1 simplification1 & h>monization ( ag5cy rules dur+ ! rulemak+ process4 ,! guidel9es %all advise ea* ag5cy to avoid regulations t are inconsi/5t or incompatible )1 or duplicative (1 o!r regulations ( ! ag5cy & ^? ( o!r ,f$]al ag5cies1 & to draft its regulations to be simple & easy to und]/&1 ) ! goal ( m9imiz+ ! pot5tial = unc]ta9ty & litigation aris+ f ! unc]ta9ty4 7#c7 ,consi/5cy 9 rulemak+ 7,a7 ,to promote consi/5cy 9 ,f$]al rulemak+1 ! ,adm9i/rator %all-- 7i7 issue guidel9es to ensure t rulemak+ conduct$ 9 :ole or 9 "p "u proc$ures specifi$ 9 provisions ( law o!r ?an ^? "u ?is sub*apt] con=m ) ! proc$ures set =? 9 ?is section to ! fulle/ ext5t all[$ by law2 & 7ii7 issue guidel9es = ! conduct ( he>+s "u subsection 7e71 :i* %all provide a reasonable opportunity = cross-exam9ation4 7,b7 ,ea* ag5cy %all adopt regulations = ! conduct ( he>+s consi/5t ) ! guidel9es issu$ "u ?is p>agraph4 7k7 ,exemption = monet>y policy ,no?+ 9 subsection 7b77#e71 7d77#a77;,e71 7e71 7f77#a71 7f77#b77;,c71 or 7f77#b77;,d7 %all apply to a rulemak+ t conc]ns monet>y policy propos$ or implem5t$ by ! ,bo>d ( ,gov]nors ( ! ,f$]al ,res]ve ,sy/em or ! ,f$]al ,op5 ,m>ket ,committee4 4 #d4 ,scope ( review ,section #gjf ( title #e1 ,unit$ ,/ates ,code is am5d$-- 7#a7 by /rik+ ,to ! ext5t necess>y & ins]t+ ,9 g5]al4--,to ! ext5t necess>y2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,judicial review ,! det]m9ation ( :e!r a rule is a major rule )9 ! mean+ ( subp>agraphs 7,b7 & 7,c7 ( section #eea7ag7 %all n be subject to judicial review4 7c7 ,/atem5t ( policy ,ag5cy guidance t does n int]pret a /atute or regulation %all be reviewable only "u subsection 7a77#b77;,d74 7d7 ,ag5cy int]pretation ( rules ,! weight t a c\rt %all give an int]pretation by an ag5cy ( its own rule %all dep5d on ! ?or\ghness evid5t 9 its consid]ation1 ! validity ( its reason+1 & its consi/5cy ) e>li] & lat] pron\ncem5ts4 7e7 ,/&>d ( review ,a c\rt %all review-- 7#a7 ! d5ial ( a petition by an ag5cy "u section #eec7;e7 = :e!r ! d5ial 0 bas$ on sub/antial evid5ce2 & 7#b7 any petition = review ( a high-impact rule "u ! sub/antial evid5ce /&>d1 reg>dless ( :e!r a he>+ 0 held "u section #eec7;e74 4 #e4 ,ag5cy guidance2 proc$ures to issue major guidance2 presid5tial au?ority to issue guidel9es = issuance ( guidance ,section #eec ( title #e1 ,unit$ ,/ates ,code1 z am5d$ by ?is ,act1 is am5d$ by add+ at ! end ! foll[+3 7l7 ,ag5cy guidance2 proc$ures ,to issue major guidance2 au?ority ,to issue guidel9es = issuance ( guidance 7#a7 ,ag5cy guidance %all-- 7,a7 n be us$ by an ag5cy to =eclose consid]ation ( issues z to :i* ! docum5t expresses a conclusion2 7,b7 /ate t x is n legally b9d+2 & 7,c7 at ! "t x is issu$ or ^u reque/1 be made available by ! issu+ ag5cy to int]e/$ p]sons & ! public4 7#b7 ,be=e issu+ any major guidance1 an ag5cy %all-- 7,a7 make & docum5t a reason$ det]m9ation t-- 7i7 su* guidance is und]/&able & complies ) relevant /atutory objectives & regulatory provisions2 & 7ii7 id5tifies ! co/s & b5efits1 includ+ all co/s to be consid]$ dur+ a rulemak+ "u subsection 7b71 ( requir+ conduct con=m+ to su* guidance & assures t su* b5efits ju/ify su* co/s2 & 7,b7 conf] ) ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs on ! issuance ( ! major guidance to assure t ! guidance is reasonable1 und]/&able1 consi/5t ) relevant /atutory & regulatory provisions & requirem5ts or practices ( o!r ag5cies1 does n produce co/s t are unju/ifi$ by ! b5efits ( ! major guidance1 & is o!rwise appropriate4 7#c7 ,! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs %all issue updat$ guidel9es = use by ! ag5cies 9 ! issuance ( guidance docum5ts4 ,! guidel9es %all advise ea* ag5cy n to issue guidance docum5ts t are inconsi/5t or incompatible )1 or duplicative (1 o!r regulations ( ! ag5cy & ^? ( o!r ,f$]al ag5cies1 & to draft its guidance docum5ts to be simple & easy to und]/&1 ) ! goal ( m9imiz+ ! pot5tial = unc]ta9ty & litigation aris+ f ! unc]ta9ty4 4 #f4 ,add$ def9ition ,section #gja7;b7 ( title #e1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 p>agraph 7#a77;,h71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#b71 by /rik+ ! p]iod at ! end1 & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#c7 sub/antial evid5ce means su* relevant evid5ce z a reasonable m9d might accept z adequate to support a conclusion 9 light ( ! record consid]$ z a :ole1 tak+ into acc\nt :atev] 9 ! record fairly detracts f ! weight ( ! evid5ce reli$ ^u by ! ag5cy to support its decision4 4 #g4 ,effective date ,! am5dm5ts made by ?is ,act to sections #eec1 #eef1 #gja7;b71 #gjd1 #gjf7;b77#d71 #gjf7;b77#e71 & #gjf7;c7 ( title #e1 ,unit$ ,/ates ,code1 %all n apply to any rulemak+s p5d+ or complet$ on ! date ( enactm5t ( ?is ,act4