The Rulemaking Process - Federal Register

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? Whydoagenciesre-opencommentsorissuemultipleproposedrules? Doagencieshaveadditionaloptionsforgatheringpubliccomments? Whyshouldyouconsidersubmittingelectroniccomments?

BeforetheFinalRule

Howdopubliccommentsaffectthefinalrule? WhatistheroleofthePresidentindevelopingafinalrule?

TheFinalRule

Howisthefinalrulestructured? Whendofinalrulesgointoeffect? Cananagencyissueafinalrulewithoutapublishingaproposedrule? Whatareinterimfinalrules&directfinalrules?

AftertheFinalRule

HowarefinalrulesintegratedintotheCodeofFederalRegulations? HowistheCongressininvolvedinreviewingfinalrules? Doestheregulatoryprocesscontinueafterrulesarepublished? Whatareinterpretiverulesandpolicystatements? Whendothecourtsgetinvolvedinrulemaking?

1Thematerialpresentedinthisguideisnecessarilygeneralinnatureandshouldnotbeusedtomakelegaldecisions.Weuse

theterms"rule"and"regulation"interchangeablyinthetext.Theguideisadaptedfromseveralmajorsources:theCornelle- RulemakingInitiative(CeRI)"RegulationRoom,"hostedbytheCornellLegalInformationInstitute(LII)at "RegMap"createdbyICFConsultingwiththecooperationofthe GeneralServicesAdministration'sRegulatoryInformationServiceCenterat 'stutorial:"TheFederalRegister: WhatitIsandHowtoUseIt"at ofTransportation's"TheInformalRulemakingProcess,"whichhasmoredetailedinformationandexamplesontherulemaking process.Inaddition,youmaywishtoconsultDOT's"RulemakingRequirements"(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; "Promptletters"fromtheOfficeofManagementandBudget(OMB); Requestsfromotheragencies; Studiesandrecommendationsofagencystaff.

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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. .Agenciesalsopublishmost ofthismaterial(theirregulatoryplans)intheFederalRegister.TheFederalRegisterversion andaseparateUnifiedAgendacollectionareavailableontheGovernmentPrintingOffice's (GPO)FederalDigitalsystem().

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-and- 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 ruleswhentheyare"significant"duetoeconomiceffectsorbecausetheyraiseimportant policyissues.Forsignificantrules,theagencymustestimatethecostsandbenefitsoftherule andconsideralternatesolutions.

 Iftheproposedrulerequiresthepublictoprovideinformationtothegovernment,theagency mustestimatethepaperworkburdenonthepublicandobtainpermissiontoproceedfrom OIRA.Inaddition,theagencymayberequiredtoanalyzeaproposedrule'simpacton: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 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,email,andtheofficialfederalelectroniccommentportal:. Inthe"SupplementaryInformation"portion,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,agencieswillspecifyacommentperiodrangingfrom30to60daysinthe"Dates" sectionoftheFederalRegisterdocument,butthetimeperiodcanvary.Forcomplex rulemakings,agenciesmayprovideforlongertimeperiods,suchas180daysormore.Agencies mayalsouseshortercommentperiodswhenthatcanbejustified. Membersofthepublicmayrequestthattheagencyallowmoretimetosubmitcomments,and agenciesmayconsiderlate-filedcomments,iftheirdecision-makingschedulepermitsit. Commentorsshouldbeawarethatagenciesgenerallyarenotlegallyrequiredtoconsiderlate- filedcomments.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.

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Why should you consider submitting electronic comments?

Mostagenciesnowprefertoreceivecommentselectronicallysothatyourinputonaproposed ruleorotherdocumentismoreeasilyavailabletothepublic.Havingelectronicdatahelps agenciesorganizethecommentsbysubjectorinotherwaystohelpthepublicandtheagency makemoreeffectiveuseofthem. Youcansubmitelectroniccommentstotheagencydocketsitebyfollowingtheinstructionsin theFederalRegister.Manyoftheproposedrulesandotherdocumentsonthissitedisplaya specialbuttonforsubmittingcommentsdirectlytotheofficialelectronicdocket.For informationonusingthefederaleRulemakingportaltosubmitcomments,gotothe "Help"pagesonsubmittingacomment.

Before the Final Rule

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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.

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