A Guide to the Rulemaking Process

Prepared by the Office of the Federal Register1

TABLEOFCONTENTS

BeforetheProposedRule

Whatgivesagenciestheauthoritytoissueregulations?
Howdoesanagencydecidetobeginrulemaking?
Whencanthepubliclearnthatanagencyplanstostartarulemaking?
Howdoesanagencyinvolvethepublicindevelopingaproposedrule?
WhatistheroleofthePresidentindevelopingaproposedrule?

TheProposedRule

Whatisthepurposeoftheproposedrule?
Howistheproposedrulestructured?
Whatisthetimeperiodforthepublictosubmitcomments?
Whydoagenciesreopencommentsorissuemultipleproposedrules?
Doagencieshaveadditionaloptionsforgatheringpubliccomments?
Whyshouldyouconsidersubmittingelectroniccomments?

BeforetheFinalRule

Howdopubliccommentsaffectthefinalrule?
WhatistheroleofthePresidentindevelopingafinalrule?

TheFinalRule

Howisthefinalrulestructured?
Whendofinalrulesgointoeffect?
Cananagencyissueafinalrulewithoutapublishingaproposedrule?
Whatareinterimfinalrules&directfinalrules?

AftertheFinalRule

HowarefinalrulesintegratedintotheCodeofFederalRegulations?
HowistheCongressininvolvedinreviewingfinalrules?
Doestheregulatoryprocesscontinueafterrulesarepublished?
Whatareinterpretiverulesandpolicystatements?
Whendothecourtsgetinvolvedinrulemaking?

1
Thematerialpresentedinthisguideisnecessarilygeneralinnatureandshouldnotbeusedtomakelegaldecisions.Weuse

thetermsruleandregulationinterchangeablyinthetext.Theguideisadaptedfromseveralmajorsources:theCornelle
RulemakingInitiative(CeRI)RegulationRoom,hostedbytheCornellLegalInformationInstitute(LII)at
http://regulationroom.org/learnaboutrulemaking/;theRegMapcreatedbyICFConsultingwiththecooperationofthe
GeneralServicesAdministration'sRegulatoryInformationServiceCenterat
http://www.reginfo.gov/public/reginfo/Regmap/index.jsp;theOfficeoftheFederalRegisterstutorial:TheFederalRegister:
WhatitIsandHowtoUseItathttp://www.archives.gov/federalregister/tutorial/onlinehtml.html#top;andtheDepartment
ofTransportationsTheInformalRulemakingProcess,whichhasmoredetailedinformationandexamplesontherulemaking
process.Inaddition,youmaywishtoconsultDOTsRulemakingRequirements(preparedbyNeilEisner,April2009),which
provideshyperlinksforeasyaccesstothestatutes,executiveorders,guidancedocuments,memoranda,etc.thatcontainthe
actuallegalrequirementsorprovideguidanceontherulemakingprocess.

Before the Proposed Rule

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What gives agencies the authority to issue regulations?

Agenciesgettheirauthoritytoissueregulationsfromlaws(statutes)enactedbyCongress.In
somecases,thePresidentmaydelegateexistingPresidentialauthoritytoanagency.Typically,
whenCongresspassesalawtocreateanagency,itgrantsthatagencygeneralauthorityto
regulatecertainactivitieswithinoursociety.Congressmayalsopassalawthatmore
specificallydirectsanagencytosolveaparticularproblemoraccomplishacertaingoal.

Anagencymustnottakeactionthatgoesbeyonditsstatutoryauthorityorviolatesthe
Constitution.Agenciesmustfollowanopenpublicprocesswhentheyissueregulations,
accordingtotheAdministrativeProcedureAct(APA).Thisincludespublishingastatementof
rulemakingauthorityintheFederalRegisterforallproposedandfinalrules.

How does an agency decide to begin rulemaking?

Congressmaypassalawthatdirectsanagencytotakeactiononacertainsubjectandseta
schedulefortheagencytofollowinissuingrules.Moreoften,anagencysurveysitsareaof
legalresponsibility,andthendecideswhichissuesorgoalshavepriorityforrulemaking.

Theseareafewofthemanyfactorsthatanagencymayconsider:

Newtechnologiesornewdataonexistingissues;
Concernsarisingfromaccidentsorvariousproblemsaffectingsociety;
RecommendationsfromCongressionalcommitteesorfederaladvisorycommittees;
Petitionsfrominterestgroups,corporations,andmembersofthepublic;
Lawsuitsfiledbyinterestgroups,corporations,States,andmembersofthepublic;
Presidentialdirectives;
PromptlettersfromtheOfficeofManagementandBudget(OMB);
Requestsfromotheragencies;
Studiesandrecommendationsofagencystaff.

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When can the public learn that an agency plans to start a rulemaking?

AgenciesarerequiredtopublishaRegulatoryPlanonceayearinthefallandanAgendaof
RegulatoryandDeregulatoryActionsinthespringandfall.TheRegulatoryPlanandthe
RegulatoryAgendaareoftenreferredtoastheUnifiedAgenda.TheUnifiedAgendaishow
agenciesannouncefuturerulemakingactivitiesupdatethepubliconpendingandcompleted
regulatoryactions.

TheUnifiedAgendaispostedonRegInfo.govandRegulations.gov.Agenciesalsopublishmost
ofthismaterial(theirregulatoryplans)intheFederalRegister.TheFederalRegisterversion
andaseparateUnifiedAgendacollectionareavailableontheGovernmentPrintingOffices
(GPO)FederalDigitalsystem(FDsys.gov).

How does an agency involve the public in developing a proposed rule?

Anagencymaytakesomepreliminarystepsbeforeissuingaproposedrule.Theygather
informationthroughunstructuredprocessesandinformalconversationswithpeopleand
organizationsinterestedintheissues.IfanagencyreceivesaPetitionforRulemakingfroma
memberofthepublic,itmaydecidetoannouncethepetitionintheFederalRegisterand
acceptpubliccommentsontheissue.

AnagencythatisinthepreliminarystagesofrulemakingmaypublishanAdvanceNoticeof
ProposedRulemakingintheFederalRegistertogetmoreinformation.TheAdvanceNoticeis
aformalinvitationtoparticipateinshapingtheproposedruleandstartsthenoticeand
commentprocessinmotion.

Anyoneinterested(individualsandgroups)mayrespondtotheAdvanceNoticebysubmitting
commentsaimedatdevelopingandimprovingthedraftproposalorbyrecommendingagainst
issuingarule.Someagenciesdevelopproposedrulesthroughanegotiatedrulemaking.Inthis
process,anagencyinvitesmembersofinterestedgroupstomeetingswheretheyattemptto
reachaconsensusonthetermsoftheproposedrule.Iftheparticipantsreachagreement,the
agencymayendorsetheirideasandusethemasthebasisfortheproposedrule.

What is the role of the President in developing a proposed rule?

BeforeaproposedruleispublishedintheFederalRegisterforpubliccomment,thePresident,
asheadoftheExecutivebranch,maytaketheopportunitytoreviewtherule.ThePresidentis
assistedbytheOfficeofInformation&RegulatoryAffairs(OIRA),whichanalyzesdraftproposed
ruleswhentheyaresignificantduetoeconomiceffectsorbecausetheyraiseimportant
policyissues.Forsignificantrules,theagencymustestimatethecostsandbenefitsoftherule
andconsideralternatesolutions.


Iftheproposedrulerequiresthepublictoprovideinformationtothegovernment,theagency
mustestimatethepaperworkburdenonthepublicandobtainpermissiontoproceedfrom
OIRA.Inaddition,theagencymayberequiredtoanalyzeaproposedrulesimpacton:small
businesses;state,localandtribalgovernments;families;federalism.Itmayalsoneedtoanalyze
issuesofjustcompensationandunfundedmandates.

The Proposed Rule

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What is the purpose of the proposed rule?

Theproposedrule,orNoticeofProposedRulemaking(NPRM),istheofficialdocumentthat
announcesandexplainstheagencysplantoaddressaproblemoraccomplishagoal.All
proposedrulesmustbepublishedintheFederalRegistertonotifythepublicandtogivethem
anopportunitytosubmitcomments.Theproposedruleandthepubliccommentsreceivedon
itformthebasisofthefinalrule.

How is the proposed rule structured?

Proposedruleshavepreambleswhichcontainasummary,dateandcontactinformation,and
supplementaryinformation.AproposedrulebeginswithaSummaryoftheissuesand
actionsunderconsideration;italsostateswhytheruleisnecessary.UndertheDatesand
Addressescaptions,theagencyinviteseveryonetocommentontheproposedrule,setsa
dateforcommentstobesubmitted,andspecifiesvariousmethodsforconveyingcomments.
Manyagenciesgiveseveraloptionsforsubmittingcomments,includingU.S.mail,private
courier,email,andtheofficialfederalelectroniccommentportal:Regulations.gov.

IntheSupplementaryInformationportion,theagencydiscussesthemeritsoftheproposed
solution,citesimportantdataandotherinformationusedtodeveloptheaction,anddetailsits
choicesandreasoning.Theagencymustalsoidentifythelegalauthorityforissuingtherule.

Followingthepreamble,theagencyusuallypublishestheregulatorytextoftheproposalinfull.
TheregulatorytextsetsoutamendmentstothestandingbodyoflawintheCodeofFederal
Regulations.Iftheamendmentsarenotsetoutinfulltext,theagencymustdescribethe
proposedactioninanarrativeform.

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What is the time period for the public to submit comments?

Ingeneral,agencieswillspecifyacommentperiodrangingfrom30to60daysintheDates
sectionoftheFederalRegisterdocument,butthetimeperiodcanvary.Forcomplex
rulemakings,agenciesmayprovideforlongertimeperiods,suchas180daysormore.Agencies
mayalsouseshortercommentperiodswhenthatcanbejustified.

Membersofthepublicmayrequestthattheagencyallowmoretimetosubmitcomments,and
agenciesmayconsiderlatefiledcomments,iftheirdecisionmakingschedulepermitsit.
Commentorsshouldbeawarethatagenciesgenerallyarenotlegallyrequiredtoconsiderlate
filedcomments.Agenciesusuallyprovideinformationintheproposedruleand/ortheir
proceduralrulesindicatingwhethertheywillconsiderlatefiledcomments.

Why do agencies re-open comments or issue multiple proposed rules?

Anagencymayextendorreopenacommentperiodwhenitisnotsatisfiedthatithasenough
highqualitycommentsorwhenthepubliccommentsmakeagoodcaseforaddingmoretime.

Similarly,anagencymayfindthatpeoplehaveraisednewissuesintheircommentsthatwere
notdiscussedintheinitialproposedrule.Asnewissuesoradditionalcomplexityarises,the
agencymaypublishaseriesofproposedrulesintheFederalRegister.

Do agencies have additional options for gathering public comments?

Duringthecommentperiod,anagencymayalsoholdpublichearingswherepeoplecanmake
statementsandsubmitdata.Someagenciesoperateunderlawsthatrequirerulemaking
hearings.Othersmayholdpublicmeetingstocollectmoreinformationortohelpaffected
groupsgetabetterunderstandingoftheproposedrule.Manyagenciesarebeginningtouse
webcastsandinteractiveInternetsessionstobroadentheaudienceattendingpublicmeetings.

Afterthecommentperiodcloses,anagencymayestablishasecondperiodforreplycomments
(commentsthatrespondtopriorcomments).Areplyperiodisnotrequiredbylaw.Thereply
commentperiodenablespeopletorespondtocommentsthatagenciesreceivedattheendof
commentperiod,creatingmoreofapublicdialog.

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Why should you consider submitting electronic comments?

Mostagenciesnowprefertoreceivecommentselectronicallysothatyourinputonaproposed
ruleorotherdocumentismoreeasilyavailabletothepublic.Havingelectronicdatahelps
agenciesorganizethecommentsbysubjectorinotherwaystohelpthepublicandtheagency
makemoreeffectiveuseofthem.

Youcansubmitelectroniccommentstotheagencydocketsitebyfollowingtheinstructionsin
theFederalRegister.Manyoftheproposedrulesandotherdocumentsonthissitedisplaya
specialbuttonforsubmittingcommentsdirectlytotheofficialelectronicdocket.For
informationonusingthefederaleRulemakingportaltosubmitcomments,gotothe
Regulations.govHelppagesonsubmittingacomment.

Before the Final Rule

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How do public comments affect the final rule?

Thenoticeandcommentprocessenablesanyonetosubmitacommentonanypartofthe
proposedrule.Thisprocessisnotlikeaballotinitiativeoranupordownvoteinalegislature.
Anagencyisnotpermittedtobaseitsfinalruleonthenumberofcommentsinsupportofthe
ruleoverthoseinoppositiontoit.Attheendoftheprocess,theagencymustbaseits
reasoningandconclusionsontherulemakingrecord,consistingofthecomments,scientific
data,expertopinions,andfactsaccumulatedduringthepreruleandproposedrulestages.

Tomoveforwardwithafinalrule,theagencymustconcludethatitsproposedsolutionwillhelp
accomplishthegoalsorsolvetheproblemsidentified.Itmustalsoconsiderwhetheralternate
solutionswouldbemoreeffectiveorcostless.

Iftherulemakingrecordcontainspersuasivenewdataorpolicyarguments,orposesdifficult
questionsorcriticisms,theagencymaydecidetoterminatetherulemaking.Or,theagency
maydecidetocontinuetherulemakingbutchangeaspectsoftheruletoreflectthesenew
issues.Ifthechangesaremajor,theagencymaypublishasupplementalproposedrule.Ifthe
changesareminor,oralogicaloutgrowthoftheissuesandsolutionsdiscussedintheproposed
rules,theagencymayproceedwithafinalrule.

What is the role of the President in developing a final rule?

InthesamewaythatthePresidentandtheOfficeofInformation&RegulatoryAffairs(OIRA)
reviewdraftproposedrulespriortopublication,thePresidentandOIRAanalyzedraftfinal
ruleswhentheyaresignificantduetoeconomiceffectsorbecausetheyraiseimportant
policyissues.ThePresidentiallevelreviewtakesplacebeforethefinalruleispublishedinthe
FederalRegister.OIRAsfinalanalysisofestimatedcostsandbenefitsmaytakeinto
considerationanycommentsandalternatesolutionssuggestedinpubliccomments.

Agenciesmayalsousethisreviewandanalysisphasetoconsultwithotheragencieswhoshare
responsibilityforissuescoveredbytherule.Insomecases,interagencyreviewismandatory.

The Final Rule

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How is the final rule structured?

Finalrulesalsohavepreambles,includingthesummary,effectivedate,andsupplementary
information.ThefinalrulepublishedintheFederalRegisterbeginswithaSummaryofthe
societalproblemsandregulatorygoalsandexplainswhytheruleisnecessary.

EveryfinalrulemusthaveanEffectiveDate.However,anyportionsthataresubjecttolater
approvalunderthePaperworkReductionActoraresubjecttoCongressionalapprovalmaybe
exceptedfromthateffectivedate.TheDatescaptionintheFederalRegistermayalsocontain
complianceorapplicabilitydates.

TheagencymuststatethebasisandpurposeoftheruleintheSupplementaryInformation
partofthepreamble.Thisstatementsetsoutthegoalsorproblemstheruleaddresses,
describesthefactsanddatatheagencyrelieson,respondstomajorcriticismsintheproposed
rulecomments,andexplainswhytheagencydidnotchooseotheralternatives.

Theagencymustidentifyitslegalauthorityforissuingtheruleandpublishtheregulatorytext
infull.TheregulatorytextsetsoutamendmentstotheCodeofFederalRegulations(CFR).
EachamendmentbeginswithinstructionsforchangingtheCFR.

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When do final rules go into effect?

Whenanagencypublishesafinalrule,generallytheruleiseffectivenolessthanthirtydays
afterthedateofpublicationintheFederalRegister.Iftheagencywantstomaketherule
effectivesooner,itmustcitegoodcause(persuasivereasons)astowhythisisinthepublic
interest.

Significantrules(definedbyExecutiveOrder12866)andmajorrules(definedbytheSmall
BusinessRegulatoryEnforcementFairnessAct)arerequiredtohavea60daydelayedeffective
date.

Can an agency issue a final rule without a publishing a proposed rule?

Yes,theAdministrativeProcedureAct(APA)permitsagenciestofinalizesomeruleswithout
firstpublishingaproposedruleintheFederalRegister.Thisexceptionislimitedtocaseswhere
theagencyhasgoodcausetofindthatthenoticeandcommentprocesswouldbe
impracticable,unnecessary,orcontrarytothepublicinterest.Thesesituationsmayinclude
emergencieswhereproblemsmustbeaddressedimmediatelytoavertthreatstopublichealth
andsafety,minortechnicalamendmentsandcorrectionswherethereisnosubstantiveissue,
andsomeinstanceswhereanagencyhasnodiscretiontoproposearulebecauseCongresshas
alreadydirectedaspecificregulatoryoutcomeinalaw.Theagencymuststateitsreasoning
forfindinggoodcauseinthepreambleofthefinalrulepublishedintheFederalRegister.

Thereareotherexceptionstoconventionalnoticeandcommentrulemaking.Anagencymay
gostraighttofinalrulemakingwithoutaproposedrulewhentheyissueinternalagency
procedures,rulesthataffectonlyfederalemployees,andrulesthatmanagefederalproperty
andrealestate.Eventhesetypesofrulescanbesubjecttoproposedrulemakingbecauseofa
specialstatutoryrequirementorbecauseaninternalagencyrulealsohasasubstantialeffecton
thepublic.

Agenciescanalsoissueandenforcerulesbyusingactualnotice,whichrequiresdirect
notificationofallaffectedpersonsandentities.Becauseitisdifficulttopinpointeveryperson
andentityaffectedbyarulemaking,thisoptionisusedmostlyforrulesthathaveaverynarrow
effectonknownorreadilydefinablepersonsorcorporations.

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What are interim final rules & direct final rules?

InterimFinalRule:Whenanagencyfindsthatithasgoodcausetoissueafinalrulewithout
firstpublishingaproposedrule,itoftencharacterizestheruleasaninterimfinalrule,or
interimrule.Thistypeofrulebecomeseffectiveimmediatelyuponpublication.Inmost
cases,theagencystipulatesthatitwillaltertheinterimruleifwarrantedbypubliccomments.
Iftheagencydecidesnottomakechangestotheinterimrule,itgenerallywillpublishabrief
finalruleintheFederalRegisterconfirmingthatdecision.

DirectFinalRule:Whenanagencydecidesthataproposedruleisunnecessarybecauseit
wouldonlyrelatetoroutineoruncontroversialmatters,itmaypublishadirectfinalruleinthe
FederalRegister.Inadirectfinalrule,theagencystatesthattherulewillgointoeffectona
certaindate,unlessitgetssubstantiveadversecommentsduringthecommentperiod.An
agencymayfinalizethisprocessbypublishingintheFederalRegisteraconfirmationthatit
receivednoadversecomments.Ifadversecommentsaresubmitted,theagencyisrequiredto
withdrawthedirectfinalrulebeforetheeffectivedate.Theagencymayrestarttheprocessby
publishingaconventionalproposedruleordecidetoendtherulemakingprocessentirely.

After the Final Rule

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How are final rules integrated into the Code of Federal Regulations?

AgenciesmustpublishthechangestotheCodeofFederalRegulations(CFR)inthefinalrule,
instructinghowamendmentsadd,revise,remove,orredesignateregulatorytext.TheCFR
containsallofthegenerallyapplicablerulesoftheFederalgovernmentwithcurrentorfuture
effect.

OnthedayafinalruleispublishedintheFederalRegister,OfficeoftheFederalRegisterand
GPOstaffbeingprocessingthematerialforcodificationintotheCFR.Rulesthatare
immediatelyeffectiveareintegratedintotheElectronicCodeofFederalRegulations(eCFR)
database(ecfr.gpoaccess.gov).Ruleswithdelayedeffectivedatesareplacedinamendment
filesandlinkedfromthemaineCFRdatabase.TheeCFRisanunofficial,butauthoritative
editorialcompilationpublishedbytheOfficeoftheFederalRegisterandGPO.Userscancheck
theupdatestatusoftheeCFRbyconsultingthehomepage.

TheofficialannualeditionsoftheCFRareassembledfromthematerialpublishedintheeCFR.
Eachofthe50subjectmattertitlesarerepublishedeachyearonastaggered,quarterlybasis,
andappearinprintandonline
(http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR).

How is the Congress in involved in reviewing final rules?

UndertheSmallBusinessRegulatoryEnforcementFairnessAct(alsoknownasthe
CongressionalReviewAct),newfinalrulesmustbesenttoCongressandtheGovernment
AccountabilityOfficeforreviewbeforetheycantakeeffect.Majorrules(onesthatare
economicallysignificantandrequireOIRAreview)mustbemadeeffectiveatleast60daysafter
thedateofpublicationintheFederalRegister,allowingtimeforCongressionalreview.In
emergencysituations,amajorrulecanbemadeeffectivebefore60days.

IftheHouseandSenatepassaresolutionofdisapprovalandthePresidentsignsit(orifboth
housesoverrideapresidentialveto),therulebecomesvoidandcannotberepublishedbyan
agencyinthesameformwithoutCongressionalapproval.Since1996,whenthisprocess
started,Congresshasdisapprovedonlyonerule.

Congressmayalsoexerciseitsoversightinotherways,byholdinghearingsandposing
questionstoagencyheads,byenactingnewlegislation,orbyimposingfundingrestrictions.

Does the regulatory process continue after rules are published?

Theregulatoryprocessentersthecompliance,interpretation,andreviewphaseafterafinal
ruleispublished.Individualsandindustriesaffectedbyarule,andtheagencycompliance
officersandinspectorswhomustenforcearule,mayneedguidancetobetterunderstandthe
regulatoryrequirements.Agenciesmaywritecompliancematerialsandtechnicalassistance
manualstodistributetothepublic.Theseguidancematerialsmaybepostedonawebsiteor
publishedintheFederalRegisterasinterpretiverules.Seemoreaboutinterpretiverulesand
policystatementsbelow.
Basedonitsexperienceinenforcingarule,anagencymaydecidetochangearule,removeit
fromtheCFRentirely,orletitstand.AlaworaPresidentialdirectivemayrequireaformal
reviewprocesseveryfewyears.Anagencymayundertakeareviewbasedonapetitionfrom
thepublic.Itsownexpertsmayalsobeginareviewprocesswhenconditionschangeandrules
seemoutdated.Ifanagencydecidestoamendorrevokearule,itmustusethenoticeand
commentprocesstomakethechange.

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What are interpretive rules and policy statements?

Interpretiverules,policystatements,andotherguidancedocumentsmaybeissuedanytime
afterafinalruleispublishedtohelpthepublicunderstandtohowaregulationappliestothem
andaffectstheirinterests.Anagencymayexplainhowitinterpretsanexistingregulationor
statute,howarulemayapplyinagiveninstance,andwhatthingsapersonorcorporationmust
dotocomply.

Thereisakeydistinctionbetweenaninterpretiveruleandafinallegislativeorsubstantive
rule.Theinterpretiveruleorpolicystatementmustnotsetnewlegalstandardsorimposenew
requirements.GuidancedocumentsdonotcontainamendmentstotheCFRandarenot
subjecttothenoticeandcommentprocess.Butinsomecases,agencieschoosetorequest
commentsoninterpretiverulesandotherguidancedocumentstoimprovethequalityand
clarityofthematerial.Interpretiverulesandpolicystatementsthathavebroadapplicability
areoftenpublishedintheFederalRegister,butsomemayonlyappearonagencywebsites.

When do the courts get involved in rulemaking?

Individualsandcorporateentitiesmaygointothecourtstomakeaclaimthattheyhavebeen,
orwillbe,damagedoradverselyaffectedinsomemannerbyaregulation.Thereviewingcourt
canconsiderwhetherarule:isunconstitutional;goesbeyondtheagencyslegalauthority;was
madewithoutfollowingthenoticeandcommentprocessrequiredbytheAdministrative
ProcedureActorotherlaw;orwasarbitrary,capricious,oranabuseofdiscretion.Anagency
headcanalsobesuedforfailingtoactinatimelymannerincertaincases.

Ifacourtsetsaside(vacates)allorpartofarule,itusuallysendstherulebacktotheagencyto
correctthedeficiencies.Theagencymayhavetoreopenthecommentperiod,publishanew
statementofbasisandpurposeintheFederalRegistertoexplainandjustifyitsdecisions,orre
starttherulemakingprocessfromthebeginningbyissuinganewproposedrule.

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