A Guide to the Rulemaking Process

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1 A Guide to the Rulemaking Process Prepared by the Office of the Federal Register 1 TABLEOFCONTENTS BeforetheProposedRule Whatgivesagenciestheauthoritytoissueregulations? Howdoesanagencydecidetobeginrulemaking? Whencanthepubliclearnthatanagencyplanstostartarulemaking? Howdoesanagencyinvolvethepublicindevelopingaproposedrule? WhatistheroleofthePresidentindevelopingaproposedrule? TheProposedRule Whatisthepurposeoftheproposedrule? Howistheproposedrulestructured? Whatisthetimeperiodforthepublictosubmitcomments? Whydoagenciesre opencommentsorissuemultipleproposedrules? Doagencieshaveadditionaloptionsforgatheringpubliccomments? Whyshouldyouconsidersubmittingelectroniccomments? BeforetheFinalRule Howdopubliccommentsaffectthefinalrule? WhatistheroleofthePresidentindevelopingafinalrule? TheFinalRule Howisthefinalrulestructured? Whendofinalrulesgointoeffect? Cananagencyissueafinalrulewithoutapublishingaproposedrule? Whatareinterimfinalrules&directfinalrules? AftertheFinalRule HowarefinalrulesintegratedintotheCodeofFederalRegulations? HowistheCongressininvolvedinreviewingfinalrules? Doestheregulatoryprocesscontinueafterrulesarepublished? Whatareinterpretiverulesandpolicystatements? Whendothecourtsgetinvolvedinrulemaking? 1 Thematerialpresentedinthisguideisnecessarilygeneralinnatureandshouldnotbeusedtomakelegaldecisions.Weuse theterms rule and regulation interchangeablyinthetext.theguideisadaptedfromseveralmajorsources:thecornelle RulemakingInitiative(CeRI) RegulationRoom, hostedbythecornelllegalinformationinstitute(lii)at about rulemaking/;the RegMap createdbyicfconsultingwiththecooperationofthe GeneralServicesAdministration'sRegulatoryInformationServiceCenterat stutorial: TheFederalRegister: WhatitIsandHowtoUseIt athttp://www.archives.gov/federal register/tutorial/online html.html#top;andthedepartment oftransportation s TheInformalRulemakingProcess, whichhasmoredetailedinformationandexamplesontherulemaking process.inaddition,youmaywishtoconsultdot s RulemakingRequirements (preparedbyneileisner,april2009),which provideshyperlinksforeasyaccesstothestatutes,executiveorders,guidancedocuments,memoranda,etc.thatcontainthe actuallegalrequirementsorprovideguidanceontherulemakingprocess.

2 Before the Proposed Rule 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; Promptletters fromtheofficeofmanagementandbudget(omb); Requestsfromotheragencies; Studiesandrecommendationsofagencystaff.

3 When can the public learn that an agency plans to start a rulemaking? Agenciesarerequiredtopublisha RegulatoryPlan onceayearinthefallandan Agendaof RegulatoryandDeregulatoryActions inthespringandfall.theregulatoryplanandthe RegulatoryAgendaareoftenreferredtoasthe UnifiedAgenda. TheUnifiedAgendaishow agenciesannouncefuturerulemakingactivitiesupdatethepubliconpendingandcompleted regulatoryactions. TheUnifiedAgendaispostedonRegInfo.govandRegulations.gov.Agenciesalsopublishmost ofthismaterial(theirregulatoryplans)inthefederalregister.thefederalregisterversion andaseparateunifiedagendacollectionareavailableonthegovernmentprintingoffice s (GPO)FederalDigitalsystem(FDsys.gov). How does an agency involve the public in developing a proposed rule? Anagencymaytakesomepreliminarystepsbeforeissuingaproposedrule.Theygather informationthroughunstructuredprocessesandinformalconversationswithpeopleand organizationsinterestedintheissues.ifanagencyreceivesa PetitionforRulemaking froma memberofthepublic,itmaydecidetoannouncethepetitioninthefederalregisterand acceptpubliccommentsontheissue. Anagencythatisinthepreliminarystagesofrulemakingmaypublishan AdvanceNoticeof ProposedRulemaking inthefederalregistertogetmoreinformation.theadvancenoticeis aformalinvitationtoparticipateinshapingtheproposedruleandstartsthenotice andcommentprocessinmotion. 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 ruleswhentheyare significant duetoeconomiceffectsorbecausetheyraiseimportant policyissues.forsignificantrules,theagencymustestimatethecostsandbenefitsoftherule andconsideralternatesolutions.

4 Iftheproposedrulerequiresthepublictoprovideinformationtothegovernment,theagency mustestimatethepaperworkburdenonthepublicandobtainpermissiontoproceedfrom OIRA.Inaddition,theagencymayberequiredtoanalyzeaproposedrule simpacton:small businesses;state,localandtribalgovernments;families;federalism.itmayalsoneedtoanalyze issuesofjustcompensationandunfundedmandates. The Proposed Rule What is the purpose of the proposed rule? Theproposedrule,orNoticeofProposedRulemaking(NPRM),istheofficialdocumentthat announcesandexplainstheagency splantoaddressaproblemoraccomplishagoal.all proposedrulesmustbepublishedinthefederalregistertonotifythepublicandtogivethem anopportunitytosubmitcomments.theproposedruleandthepubliccommentsreceivedon itformthebasisofthefinalrule. How is the proposed rule structured? Proposedruleshavepreambleswhichcontainasummary,dateandcontactinformation,and supplementaryinformation.aproposedrulebeginswitha Summary oftheissuesand actionsunderconsideration;italsostateswhytheruleisnecessary.underthe Dates and Addresses captions,theagencyinviteseveryonetocommentontheproposedrule,setsa dateforcommentstobesubmitted,andspecifiesvariousmethodsforconveyingcomments. Manyagenciesgiveseveraloptionsforsubmittingcomments,includingU.S.mail,private courier, ,andtheofficialfederalelectroniccommentportal:regulations.gov. Inthe SupplementaryInformation portion,theagencydiscussesthemeritsoftheproposed solution,citesimportantdataandotherinformationusedtodeveloptheaction,anddetailsits choicesandreasoning.theagencymustalsoidentifythelegalauthorityforissuingtherule. Followingthepreamble,theagencyusuallypublishestheregulatorytextoftheproposalinfull. TheregulatorytextsetsoutamendmentstothestandingbodyoflawintheCodeofFederal Regulations.Iftheamendmentsarenotsetoutinfulltext,theagencymustdescribethe proposedactioninanarrativeform.

5 What is the time period for the public to submit comments? Ingeneral,agencieswillspecifyacommentperiodrangingfrom30to60daysinthe Dates sectionofthefederalregisterdocument,butthetimeperiodcanvary.forcomplex rulemakings,agenciesmayprovideforlongertimeperiods,suchas180daysormore.agencies mayalsouseshortercommentperiodswhenthatcanbejustified. Membersofthepublicmayrequestthattheagencyallowmoretimetosubmitcomments,and agenciesmayconsiderlate filedcomments,iftheirdecision makingschedulepermitsit. Commentorsshouldbeawarethatagenciesgenerallyarenotlegallyrequiredtoconsiderlatefiledcomments.Agenciesusuallyprovideinformationintheproposedruleand/ortheir proceduralrulesindicatingwhethertheywillconsiderlate filedcomments. Why do agencies re-open comments or issue multiple proposed rules? Anagencymayextendorre openacommentperiodwhenitisnotsatisfiedthatithasenough 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.

6 Why should you consider submitting electronic comments? Mostagenciesnowprefertoreceivecommentselectronicallysothatyourinputonaproposed ruleorotherdocumentismoreeasilyavailabletothepublic.havingelectronicdatahelps agenciesorganizethecommentsbysubjectorinotherwaystohelpthepublicandtheagency makemoreeffectiveuseofthem. Youcansubmitelectroniccommentstotheagencydocketsitebyfollowingtheinstructionsin thefederalregister.manyoftheproposedrulesandotherdocumentsonthissitedisplaya specialbuttonforsubmittingcommentsdirectlytotheofficialelectronicdocket.for informationonusingthefederalerulemakingportaltosubmitcomments,gotothe Regulations.gov Help pagesonsubmittingacomment. Before the Final Rule How do public comments affect the final rule? Thenotice and commentprocessenablesanyonetosubmitacommentonanypartofthe proposedrule.thisprocessisnotlikeaballotinitiativeoranup or downvoteinalegislature. Anagencyisnotpermittedtobaseitsfinalruleonthenumberofcommentsinsupportofthe ruleoverthoseinoppositiontoit.attheendoftheprocess,theagencymustbaseits reasoningandconclusionsontherulemakingrecord,consistingofthecomments,scientific data,expertopinions,andfactsaccumulatedduringthepre ruleandproposedrulestages. Tomoveforwardwithafinalrule,theagencymustconcludethatitsproposedsolutionwillhelp accomplishthegoalsorsolvetheproblemsidentified.itmustalsoconsiderwhetheralternate solutionswouldbemoreeffectiveorcostless. Iftherulemakingrecordcontainspersuasivenewdataorpolicyarguments,orposesdifficult questionsorcriticisms,theagencymaydecidetoterminatetherulemaking.or,theagency maydecidetocontinuetherulemakingbutchangeaspectsoftheruletoreflectthesenew issues.ifthechangesaremajor,theagencymaypublishasupplementalproposedrule.ifthe changesareminor,oralogicaloutgrowthoftheissuesandsolutionsdiscussedintheproposed rules,theagencymayproceedwithafinalrule.

7 What is the role of the President in developing a final rule? InthesamewaythatthePresidentandtheOfficeofInformation&RegulatoryAffairs(OIRA) reviewdraftproposedrulespriortopublication,thepresidentandoiraanalyzedraftfinal ruleswhentheyare significant duetoeconomiceffectsorbecausetheyraiseimportant policyissues.thepresidentiallevelreviewtakesplacebeforethefinalruleispublishedinthe FederalRegister.OIRA sfinalanalysisofestimatedcostsandbenefitsmaytakeinto considerationanycommentsandalternatesolutionssuggestedinpubliccomments. Agenciesmayalsousethisreviewandanalysisphasetoconsultwithotheragencieswhoshare responsibilityforissuescoveredbytherule.insomecases,interagencyreviewismandatory. The Final Rule How is the final rule structured? Finalrulesalsohavepreambles,includingthesummary,effectivedate,andsupplementary information.thefinalrulepublishedinthefederalregisterbeginswitha Summary ofthe societalproblemsandregulatorygoalsandexplainswhytheruleisnecessary. Everyfinalrulemusthavean EffectiveDate. However,anyportionsthataresubjecttolater approvalunderthepaperworkreductionactoraresubjecttocongressionalapprovalmaybe exceptedfromthateffectivedate.the Dates captioninthefederalregistermayalsocontain complianceorapplicabilitydates. Theagencymuststatethe basisandpurpose oftheruleinthe SupplementaryInformation partofthepreamble.thisstatementsetsoutthegoalsorproblemstheruleaddresses, describesthefactsanddatatheagencyrelieson,respondstomajorcriticismsintheproposed rulecomments,andexplainswhytheagencydidnotchooseotheralternatives. Theagencymustidentifyitslegalauthorityforissuingtheruleandpublishtheregulatorytext infull.theregulatorytextsetsoutamendmentstothecodeoffederalregulations(cfr). EachamendmentbeginswithinstructionsforchangingtheCFR.

8 When do final rules go into effect? Whenanagencypublishesafinalrule,generallytheruleiseffectivenolessthanthirtydays afterthedateofpublicationinthefederalregister.iftheagencywantstomaketherule effectivesooner,itmustcite goodcause (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 theagencyhas goodcause tofindthatthenotice and commentprocesswouldbe impracticable,unnecessary,orcontrarytothepublicinterest. Thesesituationsmayinclude emergencieswhereproblemsmustbeaddressedimmediatelytoavertthreatstopublichealth andsafety,minortechnicalamendmentsandcorrectionswherethereisnosubstantiveissue, andsomeinstanceswhereanagencyhasnodiscretiontoproposearulebecausecongresshas alreadydirectedaspecificregulatoryoutcomeinalaw.theagencymuststateitsreasoning forfindinggoodcauseinthepreambleofthefinalrulepublishedinthefederalregister. Thereareotherexceptionstoconventionalnotice and commentrulemaking.anagencymay gostraighttofinalrulemakingwithoutaproposedrulewhentheyissueinternalagency procedures,rulesthataffectonlyfederalemployees,andrulesthatmanagefederalproperty andrealestate.eventhesetypesofrulescanbesubjecttoproposedrulemakingbecauseofa specialstatutoryrequirementorbecauseaninternalagencyrulealsohasasubstantialeffecton thepublic. Agenciescanalsoissueandenforcerulesbyusing actualnotice, whichrequiresdirect notificationofallaffectedpersonsandentities.becauseitisdifficulttopinpointeveryperson andentityaffectedbyarulemaking,thisoptionisusedmostlyforrulesthathaveaverynarrow effectonknownorreadilydefinablepersonsorcorporations.

9 What are interim final rules & direct final rules? InterimFinalRule:Whenanagencyfindsthatithasgoodcausetoissueafinalrulewithout firstpublishingaproposedrule,itoftencharacterizestheruleasan interimfinalrule, or interimrule. Thistypeofrulebecomeseffectiveimmediatelyuponpublication.Inmost cases,theagencystipulatesthatitwillaltertheinterimruleifwarrantedbypubliccomments. Iftheagencydecidesnottomakechangestotheinterimrule,itgenerallywillpublishabrief finalruleinthefederalregisterconfirmingthatdecision. DirectFinalRule:Whenanagencydecidesthataproposedruleisunnecessarybecauseit wouldonlyrelatetoroutineoruncontroversialmatters,itmaypublishadirectfinalruleinthe FederalRegister.Inadirectfinalrule,theagencystatesthattherulewillgointoeffectona certaindate,unlessitgetssubstantiveadversecommentsduringthecommentperiod.an agencymayfinalizethisprocessbypublishinginthefederalregisteraconfirmationthatit receivednoadversecomments.ifadversecommentsaresubmitted,theagencyisrequiredto withdrawthedirectfinalrulebeforetheeffectivedate.theagencymayre starttheprocessby publishingaconventionalproposedruleordecidetoendtherulemakingprocessentirely. After the Final Rule How are final rules integrated into the Code of Federal Regulations? AgenciesmustpublishthechangestotheCodeofFederalRegulations(CFR)inthefinalrule, instructinghowamendmentsadd,revise,remove,orre designateregulatorytext.thecfr containsallofthegenerallyapplicablerulesofthefederalgovernmentwithcurrentorfuture effect. OnthedayafinalruleispublishedintheFederalRegister,OfficeoftheFederalRegisterand GPOstaffbeingprocessingthematerialforcodificationintotheCFR.Rulesthatare immediatelyeffectiveareintegratedintothe ElectronicCodeofFederalRegulations (e CFR) database(ecfr.gpoaccess.gov).ruleswithdelayedeffectivedatesareplacedinamendment filesandlinkedfromthemaine CFRdatabase.Thee CFRisanunofficial,butauthoritative editorialcompilationpublishedbytheofficeofthefederalregisterandgpo.userscancheck theupdatestatusofthee CFRbyconsultingthehomepage. TheofficialannualeditionsoftheCFRareassembledfromthematerialpublishedinthee CFR. Eachofthe50subjectmattertitlesarerepublishedeachyearonastaggered,quarterlybasis, andappearinprintandonline (http://www.gpo.gov/fdsys/browse/collectioncfr.action?collectioncode=cfr).

10 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,itmustusethenotice andcommentprocesstomakethechange.

11 What are interpretive rules and policy statements? Interpretiverules,policystatements,andotherguidancedocumentsmaybeissuedanytime afterafinalruleispublishedtohelpthepublicunderstandtohowaregulationappliestothem andaffectstheirinterests.anagencymayexplainhowitinterpretsanexistingregulationor statute,howarulemayapplyinagiveninstance,andwhatthingsapersonorcorporationmust dotocomply. Thereisakeydistinctionbetweenaninterpretiveruleandafinal legislative or substantive 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;goesbeyondtheagency slegalauthority;was madewithoutfollowingthenotice and commentprocessrequiredbytheadministrative ProcedureActorotherlaw;orwasarbitrary,capricious,oranabuseofdiscretion.Anagency headcanalsobesuedforfailingtoactinatimelymannerincertaincases. Ifacourtsetsaside(vacates)allorpartofarule,itusuallysendstherulebacktotheagencyto correctthedeficiencies.theagencymayhavetoreopenthecommentperiod,publishanew statementofbasisandpurposeinthefederalregistertoexplainandjustifyitsdecisions,orrestarttherulemakingprocessfromthebeginningbyissuinganewproposedrule.

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