122106(L)NRDCv.USFDA

UNITEDSTATESCOURTOFAPPEALSFORTHESECONDCIRCUIT

AugustTerm,2012

(Argued:February8,2013Decided:July24,2014)

DocketNos.122106cv(L),123607cv(CON)

NATURALRESOURCESDEFENSECOUNCIL,INC.,CENTERFORSCIENCEINTHEPUBLICINTEREST,FOODANIMALCONCERNSTRUST,PUBLICCITIZEN,INC.,UNIONOF

CONCERNEDSCIENTISTS,INC.,

PlaintiffsAppellees,

v.

UNITEDSTATESFOODANDDRUGADMINISTRATION,MARGARETHAMBURG,inherofficialcapacityasCommissioner,UnitedStatesFoodandDrugAdministration,CENTERFORVETERINARYMEDICINE,BERNADETTEDUNHAM,inherofficialcapacity

asDirector,CenterforVeterinaryMedicine,UNITEDSTATESDEPARTMENTOFHEALTHANDHUMANSERVICES,KATHLEENSEBELIUS,inherofficialcapacityas

Secretary,UnitedStatesDepartmentofHealthandHumanServices,

DefendantsAppellants.

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Before:

KATZMANN,ChiefJudge,LYNCH,CircuitJudge,andFORREST,DistrictJudge.*

__________________

OnappealfromentryofsummaryjudgmentintheUnitedStatesDistrict

CourtfortheSouthernDistrictofNewYork(TheodoreH.KatzandJamesC.

FrancisIV,MagistrateJudges),defendantschallengethedistrictcourtsconclusion

thattheUnitedStatesFoodandDrugAdministration(FDA)isrequiredby21

U.S.C.360b(e)(1)toproceedwithhearingstodeterminewhethertowithdraw

approvalfortheuseofpenicillinandtetracyclinesinanimalfeedandthatthe

FDAsdecisiondenyingtwocitizenpetitionsurgingittoholdsuchhearingswas

arbitraryorcapriciouswithinthemeaningof5U.S.C.706(2).

REVERSED.

ChiefJudgeKatzmanndissentsinaseparateopinion.

JENNIFERA.SORENSON(MitchellS.Bernard,AvinashKar,onthebrief),NaturalResourcesDefenseCouncil,NewYork,NewYork,forPlaintiffsAppellees.

*TheHonorableKatherineB.Forrest,oftheUnitedStatesDistrictCourtfortheSouthernDistrictofNewYork,sittingbydesignation.

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ELLENLONDON(AmyA.Barcelo,BenjaminH.Torrance,AssistantUnitedStatesAttorneys,DavidJ.Horowitz,DeputyGeneralCounsel,ElizabethH.Dickinson,ChiefCounsel,FoodandDrugDivision,EricM.Blumberg,DeputyChiefCounsel,Litigation,ThomasJ.Cosgrove,AssociateChiefCounsel,DepartmentofHealthandHumanServices,onthebrief),forPreetBharara,UnitedStatesAttorneyfortheSouthernDistrictofNewYork,NewYork,NewYork,forDefendantsAppellants.

GERARDE.LYNCH,CircuitJudge:

Fornearlyseventyyears,antibioticshaveprovideddramaticmedical

advancesinthetreatmentofbacterialinfections.1Fornearlyaslong,scientists

havebeenconcernedabouttheproblemofantibioticresistance.Through

repeatedexposuretoantibiotics,somestrainsofbacteriadevelopresistanceor

immunitytoparticularantibiotics.Suchresistancepresentsaseriousthreatto

1 Thefirstmajorantibiotic,penicillin,wasdiscoveredin1928bytheScottishscientistAlexanderFleming.Itsprecisechemicalstructurewasfirstdescribedin1945bytheAmericanscientistDorothyHodgkin,andamethodforitsmassproductionwasdevelopedthatsameyear.Despitetheimportanceofherdiscovery,Hodgkinwasnotamongthescientistsawardedthe1945NobelPrizeinChemistryfortheproductionoftherapeuticpenicillin.Hodgkinlaterreceivedthatprizein1964forherdiscoveryofthestructureofvitaminB12.SeeJoachimPietzsch,TheNobelPrizeinChemistry1964:DorothyCrowfootHodgkin,Nobelprize.org,availableathttp://www.nobelprize.org/nobel_prizes/chemistry/laureates/1964/perspectives.html(lastvisitedJuly29,2013).

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humanhealth.Infectionsinhumanscausedbyantibioticresistantbacteriaresult,

onaverage,inlongerhospitalstays,worsesideeffectsoftreatment,andagreater

likelihoodofdeath.Inanefforttoforestallthedevelopmentofantibiotic

resistantstrainsofbacteria,doctorsexerciserestraintinprescribingantibiotics

andarecarefultodirectpatientstouseantibioticsonlyasprescribed.

However,foreachdoseofantibioticsgiventohumansformedical

purposes,fourdosesaregiventolivestockfornonmedicalreasonstoencourage

faster,healthiergrowth.In2009,28.8millionpoundsofantibioticswere

administeredtoanimalsraisedforfood,mostofitthroughanimalfeed.

Unfortunately,researchshowsthatbacteriathatdevelopresistancetoantibiotics

usedinanimalfeedcantransfertohumanbeingsandposearisktohuman

health.Forthatreason,variouspublicinterestorganizationshavesoughtto

forcetheFoodandDrugAdministration(FDA)toprohibittheuseofcertain

antibioticsinanimalfeed.Thiscasearisesfromonesucheffort.2

Inthislawsuit,theplaintifforganizationscontendthattheFDAisrequired

by21U.S.C.360b(e)(1)toproceedwithhearingstodeterminewhetherto

2 ForanothercasearisingfromanefforttoforcetheFDAtolimitnontherapeuticusesofantibacterialagentsinadifferentcontext,seeNaturalRes.Def.Councilv.FDA,710F.3d71(2dCir.2013).

4

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withdrawapprovalfortheuseofpenicillinandtetracyclinesinanimalfeed,and

thattheFDAsdenialoftwocitizenpetitionsdemandingsuchhearingswas

arbitraryorcapriciouswithinthemeaningof5U.S.C.706(2).Thedistrictcourt

acceptedplaintiffscontention.Becauseweconcludethatplaintiffsandthe

districtcourtareincorrect,wereversethejudgmentofthedistrictcourt.

BACKGROUND

I. FDARegulationofAnimalFeedAntibiotics

TheFDAhasstatutoryauthoritytoregulatenewanimaldrugs3introduced

intointerstatecommerce.See21U.S.C.360b(a)(1).Newanimaldrugsare

prohibitedunlessspecificallyapprovedbytheFDAfollowinganewanimaldrug

application(NADA)madebyasponsor,whichisusuallythedrug

manufacturerthatproducedthedrug.4Becauseantibioticscanbeusedinanimal

feedtoproducebiggeranimalsthatgrowfasteronlessfood,manydrug

manufacturershavesoughtapprovaltosellantibioticsforuseinanimalfeed.

3 Thetermnewanimaldrugisdefinedin21U.S.C.321(v);seenote11,infra,forthetextofthatsection.

4 Genericdrugapplicationsreceiveaslightlydifferentlabel,abbreviatedNADA.

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In1951,theFDAapprovedthefirstuseofantibioticsasingredientsin

animalfeedtoencourageanimalgrowth.Twoyearslater,itapprovedthefirst

useofantibioticsasdrugsinanimalfeed.Butbythelate1960s,theFDA

becameconcernedaboutthesafetytomanandanimalsofsubtherapeutic

antibioticusebothasageneralmatterandspecificallyinthecontextofanimal

feed.5SeeTetracycline(ChlortetracyclineandOxytetracycline)Containing

Premixes:OpportunityforHearing,42Fed.Reg.56264,56266(Oct.21,1977)

(TetracyclineNOOH).Thusbeganthedecadeslonginvestigationofthe

dangerposedbysuchuse,andtheconcernabouthumansafetyhaspersisted

eversince.

In1970,promptedbyareportpublishedbytheUnitedKingdomsJoint

CommitteeontheUseofAntibioticsinAnimalHusbandryandVeterinary

Medicine,theFDAinstitutedaTaskForcetostudytheproblem.In1972,the

TaskForcepublisheditsreport,concludingthat:(1)theuseofantibioticsin

subtherapeuticamountsfavorstheselectionofantibioticresistantbacteria;(2)

5 Subtherapeuticusesarethosethatseekincreasedrateof[weight]gain,diseaseprevention[,]etc.,asopposedtousestotreatillnessesorotherpathologicalconditions.21C.F.R.558.15(a).Othersourcespreferthetermnontherapeutic,forthesamemeaning.

6

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animalstreatedwithsuchdosesofantibioticscanserveashostsforresistant

bacteria,whichcanthenbetransferredtohumans;(3)theprevalenceofresistant

bacteriahadincreased;and(4)resistantbacteriahadbeenfoundinmeatand

meatproductsintendedforhumanconsumption.TheTaskForcesreport

proposedwithdrawingapprovalforallthenapprovedsubtherapeuticusesof

antibioticsunlessthemanufacturersofthedrugssubmittedevidenceregarding

thesafetyandeffectivenessofthedrugsasusedinanimalfeed.

In1977,afterreceivingtherequestedinformationfromthedrug

manufacturersandtherecommendationoftheAnimalFeedsSubcommitteeof

theNationalAdvisoryFoodandDrugCommittee,theFDAsBureauof

VeterinaryMedicine(CVM)6issuednoticesofopportunityforhearing

(NOOHs)withrespecttobothpenicillinandtetracyclines,anotherfamilyof

antibiotics.PenicillinContainingPremixes:OpportunityforHearing,42Fed.

Reg.43772(Aug.30,1977)(PenicillinNOOH);TetracyclineNOOH,42Fed.

Reg.56264(Oct.21,1977).Thenoticesdetailedthehistoryofsubtherapeutic

6 TheBureauofVeterinaryMedicineisnowknownastheCenterforVeterinaryMedicine.Intheinterestofsimplicity,weusetheabbreviationCVMtorefertothatsubdivisionoftheFDAregardlessofitsofficialtitleatanygiventime.

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antibioticdruguseandthescientificdataonthesafetyandeffectivenessofsuch

use,andconcludedthatthedrugmanufacturershadfailedtoresolvethebasic

safetyquestionsthatunderliethesubtherapeuticuseof[antibiotics]inanimal

feed.ThePenicillinNOOHwentontostatethattheDirectoroftheCVMhad

conclude[d],onthebasisofnewinformationbeforehimwithrespecttothesedrugproducts,evaluatedtogetherwiththeevidenceavailabletohimwhentheywereoriginallyapproved,thatthedrugproductsarenotshowntobesafeundertheconditionsofuseprescribed,recommended,orsuggestedintheirlabeling.Theevidence,infact,indicate[d]thatsuchpenicillinusemaybeunsafe,particularlyifthehigherortherapeuticlevelsofpenicillinshouldbeusedassubstitutesforthelevelscurrentlyusedsubtherapeutically.

42Fed.Reg.at43792.TheTetracyclineNOOHstatedthattheuseofsuchdrugs

wassafeonlyforalistofspecificandstrictlylimiteduses.42Fed.Reg.at56287.

LessthanayearaftertheNOOHswereissued,congressional

appropriationscommitteessetasidefundssothattheNationalAcademiesof

Sciences(NAS)couldconductfurtherresearchonthesafetyandeffectiveness

ofantibioticsinanimalfeed.ThereportissuedbytheHouseAppropriations

CommitteeincludedthinlyveiledsuggestionsthattheFDAnotgoforwardwith

thehearingprocessuntiltheresearchwascompleted.SeeH.R.Rep.No.951290,

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at99(1978).TheNASreport,whichwaslargelyinconclusivebutfoundthat

subtherapeuticuseofantimicrobialsdoesincreasetheprevalenceofresistance

amongtheE.coliandSalmonellaoftreatedanimals,alsorecommendedthat

additionalstudiesbeconducted.NationalAcademyofSciences,TheEffectson

HumanHealthofSubtherapeuticUseofAntimicrobialsinAnimalFeedxiv

(1980),http://www.nap.edu/catalog.php?record_id=21.

Twoyearslater,theHousecommitteereiterateditsdesiretoseefurther

evidencebeforeapprovingthehearingprocess.Ayearafterthat,theSenate

CommitteeonAppropriationsnotedthattheadditionalstudiesrecommendedby

theNAShadnotyetbeenconductedandconcludedthattheFDAwillbe

expectedtocontinuetoholdinabeyanceanyimplementationofitsproposal

pendingthefinalresultsoftheaboveresearchandevidentiaryhearings.S.Rep.

No.97248,at79(1981).

In1981,severalindustrygroupspetitionedtheFDAtowithdrawthe1977

NOOHs.Theyalsosoughtapprovalfornewusesofantibiotics.OnFebruary1,

1983,theFDAformallydeniedthepetitions.PenicillinandTetracycline

(ChlortetracyclineandOxytetracycline)inAnimalFeeds;DenialofPetitions,48

Fed.Reg.4544,4556(Feb.1,1983).Thepublishednoticeaccompanyingthe

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denialsstatedthattheDirector[oftheCVM]doesnothaveanylessconcernat

presentaboutthesafetyissuesthatpromptedadoptionof[theNOOHs].The

Directorhasnotchangedhisearlierconclusionthattheavailablescientific

informationwarrantstheproposedactions.Id.at4555.Inconclusion,theFDA

statedthat

[t]henoticesofopportunityforhearingrepresenttheDirectorsformalpositionthatuseofthedrugsisnotshowntobesafe.Therefore,theDirectorhasconcludedthathedoesnotwishtowithdrawthenoticesofopportunityforhearing.Instead,theDirectorwishestoplacethenoticesinabeyancependingcompletionofthestudiesmandatedbyCongress.

TheCommissioner[oftheFDA]hasreviewedtheDirectorsdecisionandconcurswithit.

ThatnoticewassignedbytheCommissioneroftheFDA.

Meanwhile,severaladditionalstudieswereeithercommissionedby

variousgovernmentagenciesorconductedbyindependentmultinational

organizations.In1984,theFDAcontractedwiththeSeattleKingCountyHealth

Departmenttoconductyetanotherstudy.Thatstudysoughttodeterminehow

easilyantibioticresistantbacteriacouldtravelfromfoodanimalstohumans.It

concludedthatsuchtransmissionwaslikely.In1987,theFDAaskedtheInstitute

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ofMedicine(IOM)toconductareviewoftheriskstohumanhealthfrom

subtherapeuticusesofantibioticsinanimalfeed.IOMfoundaconsiderable

bodyofindirectevidenceimplicatingbothsubtherapeuticandtherapeuticuseof

antimicrobialsasapotentialhumanhealthhazard,althoughitcouldnot

establishadefinitivedirectlink.In1997,theWorldHealthOrganizationhelda

meetingofexpertstodevelopareportonthequestion.TheWHOreport

recommendedceasingsubtherapeuticuseinanimalsofanyantibioticthatis

prescribedforuseinhumanstocombatbacterialinfections.Manyotherreports

werealsocompiledanddescribedintheFDAsdraftGuidanceforIndustry#209,

issuedonJune28,2010.

TheFDAneverheldthehearingsitproposedinthe1977NOOHs.On

March9,1999,agroupofpublicinterestorganizationspetitionedtheFDA,

pursuantto512(e)oftheFood,Drug,andCosmeticAct(FDCA),towithdraw

regulatoryapprovalforthesubtherapeuticuseinanimalfeedofaspecifiedlistof

antibiotics,whichincludedpenicillinandtetracyclines.OnApril7,2005,an

overlappingbutdistinctgroupofpublicinterestorganizationspetitionedthe

FDAasecondtimewiththesamerequest.Bothpetitionsreceivedpreliminary

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responses,buttheFDAissuednofinalresponseuntilaftertheinstantlawsuit

wasfiled.

Inthemeantime,theFDAissuedaseriesofguidancedocumentsto

industrygroups,inanefforttoimplementavoluntaryprogramforgradually

reducingthesubtherapeuticuseofantibioticsinanimalfeed.Theprimary

mechanismforthishopedforreductionwasanagreementtolimittheuseof

certainantibioticstotherapeuticusesauthorizedbyveterinaryprescription.The

FDAsOctober23,2003GuidanceforIndustry#152detailedtheFDAs

conclusionsaboutthedangersposedbysubtherapeuticuseofantibioticsin

animalfeed.Guidance152,byitsterms,appliedprimarilytoapplicationsfor

regulatoryapprovalfornewusesofantibioticdrugs.OnJune28,2010,FDA

releaseddraftGuidanceforIndustry#209,whichsetoutitsplantoavoidalluses

ofantibioticsthatwerenotjudicious.AdisclaimeronGuidance209specifies

that[i]tdoesnotcreateorconferanyrightsfororonanypersonanddoesnot

operatetobindFDAorthepublic.Youcanuseanalternativeapproachifthe

approachsatisfiestherequirementsoftheapplicablestatutesandregulations.

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Atthetimethislawsuitwasfiled,theFDAhadissuednofinalresponseto

thecitizenpetitionsandnoneoftheGuidancesdiscussedabovehadbeen

finalized.

II. TheInstantLawsuits

Plaintiffs,agroupofadvocacyorganizations,7filedthislawsuitinthe

UnitedStatesDistrictCourtfortheSouthernDistrictofNewYorkonMay25,

2011.Theypledtwodistinctclaims.First,theyclaimedthat21U.S.C.

360b(e)(1)compelledtheFDAtoholdthehearingproposedbythe1977

NOOHsand,ifappropriate,withdrawapprovalfortheantibioticusesthe

NOOHslisted.8Second,theyclaimedthattheFDAhadunreasonablydelayedby

failingtorespondfinallytothe1999and2005citizenpetitions,andaskedthe

7 TheplaintiffsaretheNaturalResourcesDefenseCouncil,Inc.,theCenterforScienceinthePublicInterest,theFoodAnimalConcernsTrust,PublicCitizen,Inc.,andtheUnionofConcernedScientists,Inc.

8 Plaintiffsalsopledclaimspursuantto706(1)oftheAdministrativeProcedureAct(APA),whichgenerallyauthorizescourtspresentedwithchallengestoagencyinactiontocompelagencyactionunlawfullywithheldorunreasonablydelayed.5U.S.C.706(1).BecausetheessenceofplaintiffsAPAclaimisthattheFDCArequirestheFDAtoholdthehearingsdescribedinthe1977NOOHs,thequestionposedby706isidenticaltothatposedbythetextof360b(e)itself.

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courttoorderpromptresponses.OnJuly7,2011,theyfiledanamended

complaint,whichclarifiedtheirbasisforstandingtosue.

OnOctober6,2011,aftertheFDAansweredtheamendedcomplaint,

plaintiffsmovedforsummaryjudgment.9Amonthlater,theFDAissuedfinal

responsesdenyingthe1999and2005citizenpetitions,effectivelymootingthe

plaintiffssecondclaim.Essentially,theFDAtookthepositionthatanalternative

strategyforcombattingtheilleffectsofsubtherapeuticuseofantibioticsin

animalfeedwouldbemoreefficientthanpursuinganefforttowithdraw

approvalforanysuchuses.Bywayofexplainingitsdecision,theFDAstated

thatproceedingstowithdrawdrugapprovalsareverycostlyandlengthy.The

FDAalsostatedthatanynewproceedingswouldrequireanewNOOH

incorporatingnewscientificfindingsontherelationshipbetweenhumanhealth

andsubtherapeuticusesofantibioticsinanimalfeed.Moreover,theFDA

argued,itcouldnotgrantthepetitionsbecausethewithdrawalprocesshadto

proceedonadrugbydrugbasis.Accordingly,theFDAhaddecidedtopursue

analternativebutcomplementarycourseofvoluntarymeasures.Shortly

thereafter,theFDAformallywithdrewthe1977NOOHs.WithdrawalofNotices

9 Thepartiesdidnotconductdiscovery.

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ofOpportunityforaHearing:PenicillinandTetracyclineUsedinAnimalFeed,

76Fed.Reg.79697(Dec.22,2011).

Inlightoftheseactions,theplaintiffswithdrewtheirclaimtocompel

actionontheirpetition,whichhadbeenmootedbytheFDAsdenial,and,on

February1,2012,filedasupplementalcomplaintallegingthatthedenialoftheir

petitionswasarbitraryandcapricious.Thepartiesthenfiledrenewedcross

motionsforsummaryjudgment.Thedistrictcourtruledseparatelyonthetwo

remainingclaims.InaMarch22,2012order,thedistrictcourt(TheodoreH.

Katz,MagistrateJudge)grantedplaintiffsmotionforsummaryjudgmentonthe

NOOHclaim.10NaturalRes.Def.Council,Inc.v.FDA(NRDCI),884F.Supp.

2d127(S.D.N.Y.2012).Thedistrictcourtruledthat21U.S.C.360b(e)required

theFDAtoholdahearingonceithadmadeafindingthataparticulardruguse

wasnotsafe.Itfurtherruledthatthe1977NOOHconstitutedorcontainedsuch

afinding,andthatwithdrawalofthe1977NOOHdidnoteffectawithdrawalof

thatfinding.ItthereforeorderedFDAtoinstitutewithdrawalproceedingsfor

theusesdiscussedinthe1977NOOHand,unlessthemanufacturerscouldrebut

thefinding,withdrawapprovalforthosedruguses.

10 Thepartieshadconsentedtotrialbeforeamagistratejudge.

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InaJune1,2012order,thedistrictcourt(TheodoreH.Katz,Magistrate

Judge)grantedplaintiffsmotionforsummaryjudgmentastotheclaimsthatthe

denialofthecitizenpetitionswasarbitraryandcapricious.NaturalRes.Def.

Council,Inc.v.FDA(NRDCII),872F.Supp.2d318(S.D.N.Y.2012).

Accordingtothedistrictcourt,thereasonsstatedinthewithdrawalwere

insufficienttomeeteventheverylimitedreviewauthorizedbythearbitraryand

capriciousstandard.AstotheFDAsclaimthatwithdrawalproceedingsare

costlyandlengthy,thedistrictcourtruledthatthestatutewasclearandthat

theseconcernswerenotrelevant.Inmakingthispoint,thedistrictcourtrelied

primarilyonMassachusettsv.EPA,549U.S.497(2007).NRDCII,872F.Supp.at

33334,33738.AstotheFDAsclaimthatitwaspursuingalternativevoluntary

measurestoregulatetheuseofantibiotics,thedistrictcourtagainconcludedthat

thestatutewasclearandthatvoluntarymeasureseffectiveornotcouldnotbe

substitutedforthemandatorymeasuresrequiredbythetextofthestatute.

Thegovernmenttimelyappealedbothofthedistrictcourtsjudgments.

DISCUSSION

Wereviewadistrictcourtsdecisionsonmotionsforsummaryjudgment

denovo.Chandokv.Klessig,632F.3d803,812(2dCir.2011).Summary

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judgmentisappropriateifthereisnogenuinedisputeastoanymaterialfactand

themovantisentitledtojudgmentasamatteroflaw.Fed.R.Civ.P.56(a).Here,

thefactsofthecaseareundisputed,andthequestionsposedarepurelylegal.

I. TheRequiredHearingsClaim

A. TheStatutoryText

Theprincipalquestionpresentedbythisappealiswhether21U.S.C.

360b(e)(1)requirestheFDAtoproceedwithwithdrawalhearingsforcertain

previouslyapprovedsubtherapeuticusesofantibioticsinanimalfeedbecause

theFDAhasmadeafindingthatthoseusesarenotshowntobesafeforhumans.

Thetextof360b(e)(1)clearlyrequireswithdrawalofapprovaloncesucha

findinghasbeenmade;itdoesnotequallyclearlyspecifywhentheagency

makessuchafinding,andinparticularwhetherthetypeoffindingthat

mandateswithdrawalofapprovalisaconclusionbasedoninternalagency

deliberationsthatprecedes(andthenrequires)theholdingofahearing,ora

findingthatrepresentstheconclusionreachedastheresultofsuchahearing.

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21U.S.C.360b(e)(1)addressestheFDAspowertowithdrawapprovalfor

newanimaldrug[s].11Thetextofthestatutestatesthat

(1)TheSecretary[12]shall,afterduenoticeandopportunityforhearingtotheapplicant,issueanorderwithdrawingapprovalofanapplicationfiledpursuanttosubsection(b)ofthissectionwithrespecttoanynewanimaldrugiftheSecretaryfinds...

(B)thatnewevidencenotcontainedinsuchapplicationornotavailabletotheSecretaryuntilaftersuchapplicationwasapproved,ortestsbynewmethods,ortestsbymethodsnotdeemedreasonablyapplicablewhensuchapplicationwasapproved,evaluatedtogetherwiththeevidenceavailabletotheSecretarywhentheapplicationwasapproved,showsthatsuchdrugisnotshowntobesafeforuseundertheconditionsofuseuponthebasisofwhichtheapplicationwasapproved...;

Id.

11 Newanimaldrugiselsewheredefined,subjecttolimitedexceptions,asanydrugintendedforuseforanimalsotherthanman,includinganydrugintendedforuseinanimalfeedbutnotincludingsuchanimalfeed,...thecompositionofwhichissuchthatsuchdrugisnotgenerallyrecognized,amongexpertsqualifiedbyscientifictrainingandexperiencetoevaluatethesafetyandeffectivenessofanimaldrugs,assafeandeffectiveforuseundertheconditionsprescribed,recommended,orsuggestedinthelabelingthereof.21U.S.C.321(v)(2008).

12 AlthoughthestatutereferstotheSecretaryofHealthandHumanServices,theSecretaryhasdelegatedherdutiesundertheFDCAtotheCommissioneroftheFoodandDrugAdministration.

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Thepartiesdisputethecircumstancesunderwhichthemandatory

languageshall...issueanorderwithdrawingapprovalcomesintoplay.In

particular,theydisputewhatitmeansfortheSecretarytomakeafinding,and

whenthatfindingoccurs.Thetextmakesclearthatanorderwithdrawing

approvalmustbeissued(andsofarasrelevantheremayonlybeissued)upon

theoccurrenceoftwoconditionsprecedentafindingandahearing.The

parties,ineffect,disputetherequiredandanticipatedsequenceofthose

conditions.

Thegovernmentreadsthestatuteasrequiringthesequence:hearing,

finding,order.Ineffect,itreadstheprovisiontosay,If,afternoticeanda

hearing,thesecretaryfindsthatadrugisnotshowntobesafeforuse,sheis

requiredtowithdrawapprovalofthedrug.Inthisinterpretation,the

withdrawalprocessbeginswithanoticefromtheFDAtoadrugsponsorofits

concernsaboutandrug,andofferingtheopportunityforahearingregardingthe

safetyoftheanimaldrug.If,attheconclusionofthehearing,uponconsideration

oftheevidencepresented,thesecretaryfindsthatthedrugisindeednotshown

tobesafeforuse,shemustthenissueanorderwithdrawingapprovalofthe

drug.Thatorderofeventsdependsupontheconclusionthatafindingthatan

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animaldrugisnotshowntobesafecanbemadeonlyafterthedrugssponsors

dueprocessrightsnoticeandanopportunitytobeheardhavebeenrespected.

Therefore,themandatoryshallappliesonlytotheactionwithdrawalof

approvalthattheSecretarymusttakeifthehearingresultsinafindingadverse

tothedrug.Onthegovernmentsreading,themandatoryshalldoesnotapply

totheholdingofthehearingitself,whichthegovernmentarguesisa

discretionaryactionthattheagencymayundertake,ornot,initsdiscretion,

basedonitsjudgmentaboutwhetherthescientificevidenceandsoundpublic

policywarrantinstitutingproceedingstowithdrawapproval.

Bycontrast,plaintiffsfavorthesequence:finding,hearing,finding,order.

Ineffect,theyreadthestatutetosay,Ifthesecretaryfindsadrugisnotshown

tobesafeforuse,sheshallprovidenoticetotheapplicant,holdahearing,issuea

secondfinding,andthenwithdrawapproval.Intheirinterpretation,theinitial

findingthatthedrugisnotshowntobesafeisbasedontheagencysinternal

investigationsofthescientificevidence,andcomesbeforeanyhearingisheld.On

plaintiffsreading,oncetheagencyreachestheconclusionthatthedrugisnot

showntobesafe,themandatorylanguageofthestatutebecomesapplicablethe

agencymustissueanorderofwithdrawal,thoughitmustholdahearingfirst.

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Themandatoryshallthusineffectgovernsnotonlytheremedythatmust

followaformalconclusionafterahearing,butalsotheprocessitself;after

reachingitsinitialconclusionthatthedrugisnotshowntobesafe,theagencyis

requiredtoinstituteproceedingsandeffectuatethemthroughahearing,after

which(iftheevidencepresentatthehearingsustainsthefinding)shemustissue

anorderofwithdrawal.

Asplaintiffsadmit,theirconstructionnecessarilycontemplatestwo

findingsthatadrugisnotshowntobesafeforuse:one(basedoninternal

deliberations)thattriggersthe(mandatory)hearing,andanother(afterthe

sponsorhasbeengivennoticeandanopportunitytobeheard,andbasedonthe

evidencepresentedatthathearing)thatsupportstheissuanceofanorderof

withdrawal.13Plaintiffsarguethattheinitialfindingmadebytheagencyis

subjecttorebuttalbythesponsoratthemandatedhearing;intheabsenceofsuch

13 ThehearingwouldhaveanAliceinWonderlandquality(sentencefirst,trialafterward)unlessitwereunderstoodthattheSecretarymayonlyultimatelywithdrawapprovaliftheevidencepresentedatthehearingwarrantsafindingthatthedrugisnotshowntobesafe.Therewouldbenopurposetoahearingiftheagencysinitialinternalconclusionofitselfmandatedwithdrawal,regardlessoftheoutcomeofthehearing.

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rebuttal,theoriginalfindingripensandrequiresissuanceofanorderof

withdrawal.

Thetextof360b(e)(1)itselfdoesnotunambiguouslyexpresseitherof

thesesequences.Thesyntaxmakesatleasttwothingsclear.First,becausethe

mandatoryverbshallislinkedtoissueanorderwithdrawingapprovalofan

NADAiftherequisitefindingismade,thestatuteisclearthatthewithdrawalof

theapprovalismandatoryifthepreconditionssetinthestatutearemet.Second,

thestatuteisclearthattwosuchconditionsmustbemetbeforetherequirement

thattheSecretaryshallwithdrawherapprovalistriggered:atemporal

condition(thewithdrawalordermayonlybeissuedafterduenoticeand

opportunityforhearing),andafactualcondition(withdrawalisrequiredonly

iftheSecretaryfinds...thatsuchdrugisnotshowntobesafeforuse).

Thesyntaxisnotsimilarlyclearastothetemporalrelationshipbetween

thehearingandthefinding,becausethephraseafterduenoticeand

opportunityforhearingisinsertedsomewhatawkwardlybetweenshalland

issue.Differentplacementofthenoticeandhearinglanguagecouldhave

decisivelydirectedoneortheotherofthecompetinginterpretations.Had

Congresswritten,IftheSecretaryfinds[thatthedrugisnotshowntobesafefor

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use],sheshallconductahearingonduenoticetotheapplicant,andshall

withdrawapprovaliftheevidenceatthehearingsupportsthefinding,the

plaintiffswouldclearlybecorrect:aftermakingafinding,theSecretarywould

berequiredtowithdrawapprovalofthedrug,butonlyafteranoticeandhearing

process.Incontrast,ifCongresshadwritten,TheSecretaryshallwithdraw

approval[ofanNADA]ifshefinds,afterduenoticeandopportunityforhearing

totheapplicant[thatthedrugisnotshowntobesafe],theFDAsinterpretation

wouldclearlybecorrect.Unfortunately,itwroteneither,adoptingasyntactically

awkwardvariationthatleavestheintendedsequenceambiguous.

Althoughthegrammarofthesentenceasitisactuallywrittendoesnot

absolutelycompeleitherreading,webelievethatthegovernmentsinterpretation

isfarmoreplausible,bothasamatteroflanguageandasamatterof

conventionallegalpractice.14Asnotedabove,theplaintiffsreadingrequiresnot

14Inhisthoughtfuldissentingopinion,JudgeKatzmanncorrectlynotesthat[W]ebegin...anyexerciseofstatutoryconstructionwiththetextoftheprovisioninquestion,andmove,asneedbe,tothestructureandpurposeoftheActinwhichitoccurs.(Dissentingopinion,post,at5,quotingN.Y.StateConferenceofBlueCross&BlueShieldPlansv.TravelersIns.Co.,514U.S.645,655(1995)).Thisprincipleguidesouranalysis,andconfirmsourrespectfuldisagreementwithJudgeKatzmannsconclusionregardingtheinterpretationofthestatute.

Insofarasthedissentsanalysisreferstothepurposeofthestatute,it

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onebuttwofindings,inasentencethatonlyreferstoone.Congressexpressly

providedthatwithdrawalofapprovalisrequired(indeed,suchwithdrawalis

authorized)onlyafterahearingisheldandafindingismade.Thehearing

processisthusacriticalpreconditionofthewithdrawalorder,andasplaintiffs

concede,theentirepurposeofthehearingistodeterminewhethertheevidence

doesindeedshowthatthedrugisnotshowntobesafeforuse.Thehearingthus

eventuatesinwithdrawalofapprovalonlyiftheSecretaryconcludes,basedon

hingesontheunquestionedgoalofCongresstoprotecthumanhealth.Butthisislargelyaredherring.AsJudgeKatzmannacknowledges(Dissentingopinion,post,at67),thatgoaldoesnotrequireustointerpretanyambiguityinthestatuteinthemannerthatwethinkismostconducivetoprotectingthepublichealth;thestatutereflectsinitslanguageparticularjudgmentsabouthowthatgoalshouldbepursuedandwhenitmustyieldtoorbebalancedwithotherconcerns.OurviewsregardinghowtheFDAcanbestserveitsmissionofprotectinghumanhealththroughtheuseofdrugstotreatanimalsortheanalyticimportofotherprospectivelyambiguousCongressionalstatutesmustdefertothemostreasonablereadingofthetextbeforeus.Section360b(e)(1)ismostnaturallyread(Dissentingopinion,post,at20)inthemannerthatmakesbestsenseofthestatutorylanguageitself.Thatinturncompelsustoconcludethatwhereastatuteexplicitlyconsidersonlyasinglefindinganddirectsthatanysuchfindingmandatestheagencytotakedecisiveaction,thestatuteonlyinvolvesasinglefindingbythatagency.

Insofarasthedissentaddressesthestatutorystructure,itprimarilyreliesonaperceivedparallelbetweentheproceduresforinitialapprovalofadrugandwithdrawalofthatapproval.Butthisattemptedparallelignoresthefactthatawithdrawalprocedureoccursafteradrughasalreadybeenfoundsafeadifferencethatamplyjustifiesadifferentprocess.

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theevidenceofexperienceandscientificdatapresentedatthehearing,thatthe

drugisnotshowntobesafe.Yetaccordingtotheplaintiffsreading,thestatute

makesnoexplicitreferencetoanysuchfindingattheculminationofthehearing

inplaintiffsview,theonlyfindingthatCongressexpresslyrequires,andthe

onethatthegrammaticalconstructionofthesentencemakesprerequisitetothe

withdrawalofapproval,isthefindingthattheSecretarymakesbeforethehearing

eventakesplace.15

Similarly,whiletheplaintiffsreadingwouldmaketheinitialinternal

administrativefindingofalackofshowingofsafetythetriggerforamandatory

hearing,thestatutedoesnotgrammaticallylinktheonlyfindingreferredtoin

thestatutetoamandatoryhearing,butrathertoamandatorywithdrawalof

15 Putanotherway,plaintiffsinterpretationisinternallyinconsistent.Ontheonehand,itreliesontheliterallanguageofthestatutetoinsistthatuponthefindingoflackofshowingofsafetybywhichplaintiffsmeanthepreliminaryinternalconclusionoftheagencythatleadstotheissuanceofanNOOHwithdrawalofapprovalismandatory,butontheothertheyacknowledgethatthatpreliminaryfindingdoesnotandcannotinfactmandatewithdrawalofapproval,becauseitleadsonlytoahearingthatmayormaynotresultinafindingthatthedrugisnotshowntobesafe.Plaintiffsinsistthatthefindingorpreliminaryassessmentoftheagencymandatesthattheagencyholdahearing,butthefindingreferredtoin360b(e)(1)requiresthattheSecretaryissueanorderwithdrawingapprovalofthedrug.Onlyafindingthatismadeafternoticeandanopportunityforahearingcanhavethiseffect.

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approval.Moreover,thestatutedoesnotrequirewithdrawalofapprovalbased

solelyuponaninternal,prehearingfindingwithdrawalofapprovalmust

awaittheconclusionofthehearing,atwhichfurtherfindingswouldhavetobe

made.Atthatpoint,thewithdrawalisnolongerthemandatoryconsequenceof

theinitialfindingifthehearingdemonstratedthesafetyofthedrug,

withdrawalofapprovalwouldnotberequired,orevenpermitted.Itis,instead,

theconsequenceofthefurtherfindingattheendofthehearing,basedonthe

evidencepresentedthere.Accordingtoplaintiffs,Congressmeanttomandate

thatuponmakingthefindingreferredtoin3609(e)(1)(A),theSecretaryis

requiredtoholdahearing,andyetCongressprovidedthatuponmakingsucha

findingtheSecretaryshallissuenotanoticeofopportunityforahearing,buta

withdrawalofapprovalofthedrug.Inshort,itwouldbesingularlyoddfor

Congresstohavechosenthelanguagethatitdidtodescribetheprocessthateven

theplaintiffsconcedeitintended.

Thegovernmentspreferredreadingyieldsnosuchdifficulties.Whileitis

truethatthestatutewouldreadmoresmoothly,andwouldmoreclearlyexpress

thegovernmentsposition,ifthephraseafterduenoticeandanopportunityfor

hearingwereplacedafterfinds,ratherthanbetweenshallandissue,

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nothinginthestatutorylanguageneedstobetwistedtoyieldthegovernments

interpretation.Althoughtheplacementofthenoticeandhearingprovisionis

awkward(oneithersidesinterpretation),evenasplaced,itisentirelyconsonant

withthegovernmentsreading.Thereisnothingsyntacticallydifficultorodd

aboutprovidingthattheSecretaryshallwithdrawherapprovalofadrug,aftera

noticeandhearingprocess,ifafindingismade(aftersuchprocess)thatthedrug

isnotshowntobesafe.

B. Context

Thepartiescallourattentiontovariousaspectsofthelargerstatutory

contextthatmightcastfurtherlightonthemeaningofthisparticularprovision.

Thecitedportionsofthestatute,however,donotprovidemuchhelpinclarifying

themeaningoftheprovisioninquestion,andcertainlydonotprovidesufficient

instructiontoovercomethereadingderivedfromthelanguageofthedebated

textitself.

Asthepartiesnote,differentlanguagewithinthesamestatutory

subsectionprovidesforemergencywithdrawalofapprovalforanimaldrugsif

theSecretary...findsthatthedrugsposeanimminenthazardtothehealthof

manoroftheanimals.21U.S.C.360b(e)(1)(lastparagraph).Insuchacase,

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theSecretarybutnotanydelegatemayimmediatelyandwithoutahearing

suspendapprovalforthedruginquestion.Thatprovisioncanbeusedto

supporteitherside.Ontheonehand,plaintiffsarguethatitslanguagesupports

thenotionthattheSecretarycanmakefindingsbyaninternaladministrative

process,withoutnoticeorahearing.Ontheotherhand,thegovernmentargues

thatthespecialexceptionpermittingemergencyinterimrelieftoprevent

imminenthazards,andthereservationofauthoritytomakesuchemergency

findingstotheSecretary,servestounderscorethegeneralandotherwise

applicablerulethatfindingsthatinducefinalagencyactionsadverseto

applicantsmustbemadeafternoticeandhearing,andmustrepresentthefinal

conclusionoftheagency,ratherthananinterimjudgmentdelegabletolower

rankingofficials.Neitheroftheseinferencesfromtheemergencysuspension

provisioncanbedismissedasimplausible,butneitherpersuasivelyilluminates

theprocessanticipatedbythelanguageinquestioninthiscase.

Thedistrictcourtalsoreliedonadistinctionbetween360b(e)(1)andthe

precedingsubsectionofthestatute,360b(d)(1),tosupportitsconclusionthat

findingscouldprecedehearingsforpurposesof360b(e)(1).Section360b(d)(1)

whichliststhepermissiblegroundsonwhichtheSecretarymayinitiallydenyan

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applicationforapprovalofanewanimaldrugclearlystatesthatfindingsoffact

mustoccurafterahearing,byplacingtheafterduenotice[and]hearing

languageimmediatelyaftertheverbfinds.16Thatdifferenceinlanguage,the

districtcourtconcluded,suggeststhatCongressintendeddifferentschemes

underthetwosubsections.Thegovernmentchallengesthatreading,however,

arguingthat360b(d)isexpresslyconnectedtothelanguageofthepreceding

360b(c)(1),whichinturnexplicitlycontemplatesthatsomefindingsmaybe

madewithoutahearing.17Inthatcontext,itmakessensethatCongresswould

usemoresharplycontrastinglanguagetodistinguishthefindingsmadeunder

subsection(d)fromthoserequiredinsubsection(c).Bycontrast,under

360b(e)(1),noorderwithdrawingapprovalmayissuebeforeahearingunless

thedrugrepresentsanimminenthazard.Inthegovernmentsreading,the

16 21U.S.C.360b(d)(1)states:IftheSecretaryfinds,afterduenoticetotheapplicantinaccordancewithsubsection(c)ofthissectionandgivinghimanopportunityforahearing,inaccordancewithsaidsubsection,that[oneofninespecifiedconditionsissatisfied,]heshallissueanorderrefusingtoapprovetheapplication.If,aftersuchnoticeandopportunityforhearing,theSecretaryfindsthat[thoseconditionsarenotmet],heshallissueanorderapprovingtheapplication.

17 Specifically,theSecretaryisauthorizedtoapproveanapplicationforanewanimaldrugifshefindsthatnoneofthegroundsfordenyingapprovalspecifiedin[360b(d)]applies.21U.S.C.360b(c)(1).

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differenceinlanguagebetweensubsections(d)and(e)reflectsthediffering

proceduresforapprovalofanewdrugandforthewithdrawalofapprovalofa

previouslyapproveddrug,ratherthananyintentiontolimitagencydiscretionto

institute,pursue,orabandonprocedurestowithdrawdrugapprovals.

Again,wefindbothpartiesinferencesfromthelanguageof360b(d)

reasonable.Butneitherissufficientlycompellingeithertostronglycorroborate

ortoseriouslyundermineourreadingofthetext.Asnotedabove,itis

unquestionablyclearfromthetextthatthemandatetoorderwithdrawalonly

appliesaftertheagencyhasheldahearing.Indeed,itisclearfromthetextthat

anorderwithdrawingapprovalmaynotbeentered(exceptintheemergency

circumstancesreferredtoin360b(e)(1))withoutprovidingnoticeandahearing

tothedrugssponsor.Itseemstousthat,whenastatuteprovidesthatanagency

musttakesomeactionafterahearingifitfindssomethingtobetrue,themore

persuasivereadingisthatthefindingreferredtoisthefruitoftherequired

hearing.

C. TheRelevantRegulations

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Bothpartiesarguethatvariousregulationsimplementingthestatute

supporttheirrespectiveinterpretations.Forthereasonssetforthbelow,wedo

notfindtheseargumentsespeciallyhelpful.

ThegovernmentarguesthattheFDAsinterpretationofthestatuteis

entitledtodeference.Wegenerallygivedeferencetoanagencysinterpretation

ofstatutesthattheagencyadministers.SeeChevronU.S.A.,Inc.v.NaturalRes.

Def.Council,Inc.,467U.S.837,84445(1984).TheSupremeCourthasheldthat

theFDAisentitledtodeferencewhenitinterpretsTitle21oftheUnitedStates

Code,FDAv.Brown&WilliamsonTobaccoCorp.,529U.S.120,132(2000),

becausetheFDA,asdesigneeoftheDepartmentofHealthandHumanServices,

istheagencytaskedwithadministeringtheFDCA.Wewillthereforedefertothe

FDAsinterpretationifCongresshasnotdirectlyspokentotheprecisequestion

atissueandtheagencycanpointtoanofficialinterpretationthatsetsfortha

permissibleconstructionofthestatute.

However,beforewedefertoanagencysinterpretationofastatute,we

mustidentifyanagencydocumentsettingforththatinterpretation.Thelevelof

deferencetoanagencysinterpretationofitsownstatutedependsonthenature

ofthedocumentsettingforththeinterpretation.Regulationspromulgatedaftera

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periodofnoticeandcommentaretypicallygrantedtherelativelystrongformof

deferencedescribedbyChevron.SeeUnitedStatesv.MeadCorp.,533U.S.218,

22830(2001).Wegivesubstantiallylessdeferencetoposthocinterpretations

offeredonlyforpurposesoflitigation,particularlywhenthoseinterpretations

representadeparturefrompriornorms.SeeAm.FednofState,County,&

Mun.Emps.v.Am.IntlGrp.,Inc.,462F.3d121,129(2dCir.2006),quoting

Atchison,Topeka&SantaFeRy.Co.v.WichitaBd.ofTrade,412U.S.800,808

(1973).ThegovernmenturgesustoapplyChevrondeferencetotheFDAs

interpretationofthestatuteasembodiedinitsnoticeandcommentregulations.

Thegovernment,however,overlooksabasicpredicateofadministrative

deference.Inordertomeritdeferenceonagivenissue,aparticularregulation

mustshedlightonewayortheotherontheissue.Thegovernmentpointsto

threeregulationstosupportitsposition,butnoneofthemhelpdecidethe

questionbeforeus:whetherthefindingsreferredtoin360b(e)precede

hearings,orfollowthem.Thegovernmentconcedesthattheregulationsitcites

donotexplicitlyundertaketointerpretthestatutoryprovisionatissueand

answerthequestionbeforeus,butneverthelessarguesthattheregulations

presupposeananswertothatquestion.

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First,thegovernmentrelieson21C.F.R.5.84,whichauthorizesthe

DirectorofCVM,astheSecretarysdelegate,toissueNOOHsonthelatters

behalf.18Specifically,theregulationprovidesthattheDirectormayissueNOOHs

or,ifthesponsorhaswaivedtherighttoahearing,theDirectormayissuean

orderofwithdrawal.Butthatregulationfailstogiveanyindicationaboutwhat,

ifany,conditionsmightrequireahearing.Thegovernmentarguesthat,because

5.84representsapartialdelegationoftheSecretarysdutiesunder360b(e)(1)

onlyforpurposesofissuingNOOHs,itdoesnotauthorizetheDirectortomake

findings,andthatthereforetheissuanceofanNOOHisneverprecededbya

findingasdefinedinthestatute.Buttheregulationmerelystatesthat[t]he

DirectorandDeputyDirector[oftheCVM]areauthorizedtoissue[NOOHs]...

andtoissuenoticesofwithdrawalofapprovalwhenopportunityforhearinghas

1821C.F.R.5.84hasbeenformallywithdrawninanamendmentoftheregulationsgoverningtheFDAorganizationalstructure,promulgatedbyarulethatiseditorialinnature.RevisionofOrganizationandConformingChangestoRegulations,77Fed.Reg.1596102(Mar.19,2012)(codifiedat21C.F.R.ChapterI).ThesubstanceofthedelegationfromtheSecretarytotheCVMcontainedwithin21C.F.R.5.84isnowauthorizedbyFDAStaffManualGuides,VolumeIIDelegationofAuthority,SMG1410.503(Feb.24,2011).Asthemodificationtotheregulationswaseditorialratherthansubstantive,thelanguageofthedelegationremainsthesame,andbothpartiesimplicitlyagreethat5.84remainsineffect,weaddresstheregulationhere.

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beenwaived.21C.F.R.5.84(a)(1)(2).Itisthusequallyplausibletoread5.84

asdelegatingtotheDirectorofCVM19theresponsibilityformakinganyfindings

thatmighttriggerthemandatoryissuanceofNOOHsandanyresultingactions.

Thegovernmentnextpointsto21C.F.R.514.200(c),whichsetsoutthe

possibleresponsesasponsormaymaketoanNOOH,anddescribestherequisite

showingasponsormustmaketosecureanactualhearingasopposedtoa

decisiononthepapers.Itarguesthatthatregulationprecludesplaintiffsreading

becauseanyprehearingfindingsarenecessarilypreliminary.Specifically,the

regulationrequiresasponsorseekingahearingto

giv[e]thereasonwhytheapplicationshouldnotberefusedorshouldnotbewithdrawn,togetherwithawellorganizedandfullfactualanalysisoftheclinicalandotherinvestigationaldataheispreparedtoproveinsupportofhisoppositiontotheCommissionersproposal.Arequestforahearingmaynotrestupon

19 Asthedistrictcourtnoted,theCommissioneroftheFDAratifiedthejudgmentreflectedinthe1977NOOHsbyconcurringinapolicystatementpublishedintheFederalRegisterwiththeDirectors1983decisionnottorescindthoseNOOHs.PenicillinandTetracycline(ChlortetracyclineandOxytetracycline)inAnimalFeeds;DenialofPetitions,48Fed.Reg.4554,4556(Feb.1,1983)(TheCommissionerhasreviewedtheDirectorsdecisionandconcurswithit.Inaddition,forthereasonsdiscussedabove,theCommissionerhasdecidedthathewillnotwithdrawtheadvancenoticeofhearingortheproposaltorestricttherapeuticapprovalstoprescriptionuse,butwillholdtheminabeyance.).

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mereallegationsordenials,butmustsetforthspecificfactsshowingthereisagenuineandsubstantialissueoffactthatrequiresahearing.Whenitclearlyappearsfromthedataintheapplicationandfromthereasonsandafactualanalysisintherequestforthehearingthatnogenuineandsubstantialissueoffactprecludestherefusaltoapprovetheapplicationorthewithdrawalofapprovaloftheapplication(forexample,noadequateandwellcontrolledclinicalinvestigationstosupporttheclaimsofeffectivenesshavebeenidentified),theCommissionerwillenteranorderonthisdata,statinghisfindingsandconclusions.

21C.F.R.514.200(c)(emphasisadded).Thegovernmentarguesthat,becausea

decisiontograntahearingrepresentsonlytheCommissionersdetermination

thattheremaybeagenuineandsubstantialissueoffactpreclud[ing]...the

withdrawalofapprovaloftheapplication,itcannotrepresentaconclusive

findingtriggeringamandatoryduty.Bycontrast,theplaintiffsargue,andthe

districtcourtagreed,thatnotonlydoes514.200(c)failtosupporttheposition

thatfindingsmaytakeplaceonlyafterahearing,butitalsoexplicitly

contemplatesfindingsevenintheabsenceofahearing.Ifthesponsorswritten

responsetoaNOOHisinsufficient,theCommissioneristoenteranorderof

withdrawalbasedon,amongotherthings,thedataintheinitialapplication.

Theregulation,itseemstous,simplyprovidesamechanismforakindof

summaryjudgmentproceedingthatmightobviateanevidentiaryhearing.If

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theapplicantrequestsahearing,thedecisiontowithdrawapprovalofthedrug

mustbebasedeitheronformalfindingsderivedfromtheevidenceadducedat

ahearingor,wherethattherequestforahearingdoesnotraiseagenuineissue

ofdisputedfact,onasummaryjudgmentlikeconclusion.Tothatextent,the

regulationisconsistentwiththegovernmentsbasiccontentionthatfindings

normallyresultfromanadjudicativeprocess,andaremadeafterthatprocessis

instituted.Itdoesnot,however,directlyaddressletaloneleadusto

conclusivelyrejectplaintiffscontentionthattheentireproceedingistriggered

byanagencyfinding.Wethereforeconcludethatthisregulationdoesnot

embodyanunambiguousinterpretationof360b(e)(1)towhichwemustdeferin

thiscase.

Finally,thegovernmenturgesustotakeaccountof21C.F.R.

10.55(b)(2)(i),whichprovidesfortheseparationofinvestigativeand

adjudicativeresponsibilitieswithintheFDAintheeventofahearing.

Specifically,thatregulationprovidesthat,fromthetimeoftheannouncementof

aformalhearing,CVMwillberesponsibleforallinvestigativefunctionsand

forpresentingtheFDAscasebeforetheadjudicator.Accordingtothe

government,thisseparationoffunctionsreflectsFDAsunderstandingthat

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throughoutthewithdrawalprocess,CVMdoesnotspeakonbehalfoftheFDA.

BecauseCVMcannotspeakonbehalfoftheCommissioneroncehearing

proceedingshavebeeninstituted,thegovernmentarguesthatanyfindingby

CVMcannottriggeramandatorydutyonthepartoftheCommissioner.That

argumenthasonemajorflaw:thefindingthatplaintiffsarguetriggeredthe

FDAsdutytoproceedwiththehearingnecessarilyprecededtheperiodof

separationofadministrativefunctions.Becausefunctionsareseparatedonly

uponpublicationofanNOOH,anythingthatprecedesorisincludedinthe

NOOHmighthaverepresentedanactionbytheCommissionerthroughher

delegate,theDirectorofCVM.

WearethereforeunabletoidentifyaregulationpromulgatedbyFDA

pursuanttoitsnoticeandcommentrulemakingauthoritythatclearlyreflectsa

definitiveinterpretationof360b(e)(1).Whiletheregulationsrelieduponbythe

FDAdonotexpresslyadoptorunambiguouslyrequireanyparticular

interpretationofthecontestedlanguagetowhichwemustaccordChevron

deference,theystillprovidesomeguidance.Aswediscussbelow,webelieve

thattheregulationsrelieduponbytheFDAreflectaconventionalunderstanding

oftheadministrativeprocessthatisconsistentwiththeinterpretationof

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360b(e)(1)advancedbythegovernment.Wecannotconclude,however,that

anyofthoseregulationsdirectlyspeaktothespecificquestionofstatutory

interpretationbeforeus,orreflectaclearadoptionbytheagencyofanyposition

onthatquestion.

Plaintiffs,fortheirpart,alsoseeksupportinFDAregulations.Theyargue

thattheregulationmostonpointis21C.F.R.514.115(b)(3)(ii),whichdetailsthe

proceduresforwithdrawalofapprovalofanNADA.Thatregulationprovides:

TheCommissionershallnotifyinwritingthepersonholdinganapplication

approvedpursuanttosection512(c)oftheactandaffordanopportunityfora

hearingonaproposaltowithdrawapprovalofsuchapplicationifhefindsthat

oneoftheconditionsdescribedin360bismet.21C.F.R.514.115(b)(3)

(emphasisadded).Thatregulationunquestionablylendsplausibilityto

plaintiffsreadingofthestatutebecauseitclearlycontemplatesthatthe

CommissionermustmakesomesortoffindingbeforetheissuanceofanNOOH.

Indeeditwaslargelyonthebasisof514.115(b)(3)(ii)thatthedistrictcourt

interpretedthestatutetorequiretheFDAtoproceedwiththehearing.

Thegovernment,however,arguesthatthisregulationisinapposite

becauseidenticalwordsneednothaveidenticalmeaningswhenusedin

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differentcontextsandtheFDAsuseoffindsintheregulationrefersonlytoa

preliminaryfinding.Whilethegovernmentsargumentishardlycompelling,the

regulationcanindeedbereadasitproposes.Moreover,thattheFDAregulation

referstoafindingmadebytheCommissionerbeforeinstitutingahearingdoes

notmeanthattheregulationisintendedtosetforththeagencysdefinitive

interpretation,orindeedanyinterpretationatall,ofthestatutorylanguagewhose

meaningthepartiesheredispute.Inotherwords,plaintiffsrelianceon

514.114(b)(3)(ii)suffersfromthesameflawastheFDAsrelianceonthe

regulationsthatitcites.Allofthecitedregulationsaredraftedtodefine

administrativeprocedures,andnottointerpretthemandatesetforthby

Congressin360b(e)(1).Theuseofcertainlanguageinthoseregulationsorthe

natureoftheproceduresthattheycreatemaylendsomesupporttotheposition

ofonesideortheother,buttheregulationssimplycannotbesaidtoanswerthe

questionbeforeus.

Inshort,wearenotrequiredtodefertoanagencysinterpretationofa

statutewhenitsregulationsdonotdirectlyaddressthequestionbeforetheCourt,

andwhenthelanguageofoneregulationappearstobeintensionwiththe

agencysinterpretationofthestatuteadvancedforpurposesoflitigation.We

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thereforeconcludethatChevrondeferencedoesnotprovideananswertothe

questionbeforeus.

D. BackgroundLegalConcepts

Wetakesomecomfortfromthefactthatourinterpretationofthestatutory

textisconsistentwithordinaryunderstandingsofadministrativeandjudicial

litigationprocesses.Ininterpretingastatute,courtsgenerallypresumethat

Congressactsagainstthebackgroundofourtraditionallegalconcepts.United

Statesv.U.S.GypsumCo.,438U.S.422,437(1978).SeealsoUnitedStatesv.

Pacheco,225F.3d148,157(2dCir.2000).Ofcourse,Congressmaydepartfrom

suchtraditions;itmayusewordsinwaysthatareunconventional,oradopt

innovativeprocedures.Butwhenastatutedoesnotprovidecleardirection,itis

morelikelythatCongresswasadopting,ratherthandepartingfrom,established

assumptionsabouthowourlegaloradministrativesystemworks.Wewillnot

lightlyassumealessconventionalmeaningabsentaclearindicationthatsucha

meaningwasintended.Inourview,theinterpretationadvancedbythe

governmentismoreinaccordancewithsuchconventions.

First,thegovernmentsinterpretationismoreconsistentwithourusual

understandingofanadministrativefinding.Anagencyfindingtypically

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representsanofficialdetermination,reflectingafinal,deliberativedecision

issuingattheconclusionofaprocess,andtakingafixedformembodiedinan

identifiabledocument.Judicialoradministrativefindingsmostcommonlyare

adoptednotasaprerequisitebutasaconsequenceofahearingorotherofficial

proceeding.Forexample,BlacksLawDictionarydefinestheverbfindasTo

determineafactindisputebyverdictordecision,BlacksLawDictionary707(9th

ed.2009)(emphasisadded),andthenounfindingoffactasAdetermination

byajudge,jury,oradministrativeagencyofafactsupportedbytheevidencein

therecord,usu.presentedatthetrialorhearing,id.at708(emphasisadded).Thus

afindingtraditionallyoccursafteradversarialpartiesaregivennoticeofa

hearingandanopportunitytobeheardthere,atleastifhearingsare

contemplatedaspartoftheadministrativescheme.

Otherareasofthelawdefinefindingstomeanwrittenconclusions

issuedonlyatthecompletionofanadministrativeprocess.Forexample,for

purposesofjudicialreviewofagencyadjudicationundertheSocialSecurityAct,

wehaveheldthatthetermfindingsreferstotheagencysontherecord

determinationsatahearing,andthattheagencyhasanaffirmativedutyto

developtherecordduringthehearingtofacilitatejudicialreview.SeePrattsv.

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Chater,94F.3d34,37(2dCir.1996);seealso42U.S.C.405(g).Similarly,albeit

inacontextthatdoesnotnecessarilycontemplatehearings,FederalRuleof

Evidence803(8)(A)(iii),whichprovidesanexceptiontothehearsayrulefor

writtenpublicrecordsandreports,permitsadmissionintoevidencefindings

fromalegallyauthorizedinvestigation,andtheSupremeCourthasinterpreted

theruleasrequiringaconclusion...basedonafactualinvestigation.Beech

AircraftCorp.v.Rainey,488U.S.153,170(1988)(emphasisadded).Inthese

instances,findingsarewrittenandissueonlyattheconclusionoftheentire

process.

Wedonotsuggestthatthetermcannotbe,orindeedisnot,sometimes

usedinadifferentsense.Asplaintiffspointout,eveninthisveryregulatory

scheme,theFDAusesthewordfindinacontextthatclearlyreferstoa

preliminaryfindingthatdoesnotsharethecharacteristicsdiscussedabove.See21

C.F.R.514.115(b)(3)(ii),discussedabove.Similarly,theemergencysuspension

proceedingsin360b(e)(1)itselfrefertofindingsthataremadebytheSecretary

withoutahearing,though,notablyinthatcontext,thefindingisthebasisforan

actionthathasanimmediatelegaleffectontherightsofadrugsponsor,rather

thanbeingthebasisofadecisiontoinstituteaprocessthatmayeventuallylead

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tosuchaneffect.Nevertheless,wherethecontextdoesnotclearlyindicatetothe

contrary,typicalusagesuggeststhatanadministrativefindingreflectsthe

agencysfinaldecisionissuedattheconclusionofaprocess,ratherthana

preliminaryassessmentthatcontemplatesfurtherproceedingsbeforefinalaction

istaken.20

Second,thefunctionofthefindingcontemplatedby360b(e)(1),andthe

mandatethatCongressattachedtothemakingofsuchafinding,isconsistent

withthismorenaturalmeaning.Asplaintiffsthemselvesemphasize,afinding

bytheCommissionerthatadrugisnotshowntobesaferequirestheFDAto

issueanorderwithdrawingapprovalofthedrug.21U.S.C.360b(e)(1).The

FDAisnotaccordeddiscretiontoadoptadifferentremedy.Theconsequencesof

suchawithdrawalaresignificantforsocietyandforthesponsorormanufacturer

20LookingbeyondthespecificcontextoftheFederalFood,Drug,andCosmeticAct,JudgeKatzmanncitesanumberofstatutesinwhichCongresshasusedlanguagesimilartothatatissuehere.(Dissentingopinion,post,at1920).Significantly,however,hecitesnojudicialinterpretationofthislanguagethatsupportsplaintiffsreadings(or,forthatmatter,thatsupportsours).ThefactthatCongresshascreatedsimilarambiguitiesinothercontextstellsusnothingabouthowtoresolvetheambiguity.Similarly,weareunpersuadedbythedissentssuggestionthattheSupremeCourtoffhandedlyendorsedplaintiffsviewof360(b)(1)(B)inBrown&Williamson(Dissentingopinion,post,at13).Inthecitedpassage,529U.S.at134,theCourtsimplyrepeats,inaslightlycondensedform,theambiguouslanguageofthestatuteitself.

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ofthedrug.ItislogicaltoassumethatCongresswouldmandatewithdrawalof

approvalofadrugwhenithasbeendeterminedthatthedrughasnotbeen

showntobesafebyaformaldecisionoftheagency,afteracarefulhearingat

whichevidencebothforandagainstthesafetyofthedrughasbeenpresented.

Incontrast,itwouldseempeculiarforCongress(absentanemergencyofthesort

authorizingunilateralagencyactionprovidedforinthelastparagraphof

360b(e)(1))tomandatesuchastrongremedybasednotonafinaldecisionby

theagencyheadafterafulldeliberativeprocess,butonapreliminaryconclusion

reachedbylowerlevelofficialsbeforethoseaffectedhavehadanopportunityto

beheard.

Andofcourse,asplaintiffsineffectconcede,Congressclearlyhasnotdone

so.Whilethelanguageofthestatutedictatesthatwithdrawalofapprovalisthe

necessaryconsequenceofafindingthatananimaldrugisnotshowntobesafe,

thestatuterequiresnoticetothesponsorandanopportunityforahearingbefore

afinalorderofwithdrawalmayissue,andplaintiffsagreethatsuchanorder

mayissueonlyifthehearingresultsinafindingbytheSecretarythatthedrugis

notshowntobesafe.Undertheliteralwordsofthestatute,aswellasin

accordancewithcommonsense,theagencymustissueanorderwithdrawing

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approvalwhenitfindsthatthedrugisnotshowntobesafesomethingthat,as

amatterofstatutorycommandanddueprocess,mayonlyoccurafterthe

hearing.

Third,theadministrativeprocesscontemplatedbythegovernments

interpretationofthestatuteaccordswithourtraditionalexpectationsof

governmentalenforcementoflegalrules.Thetraditionalmodelof

administrativeorjudicialenforcementfeaturesaninvestigationbyexecutiveor

administrativepersonnel,followedbytheissuanceofacaseinitiatingdocument

thatsetsforththeconclusionsorchargesreachedbytheprosecutingauthority,

followedbyahearing.Thatprocessculminatesinafinaladjudicationthatis

reachedbytheagencyandembodiedinaformaldecision,andimposeswhatever

remediesorpenaltiesareapplicable.Incivilandcriminalactions,theinitial

conclusionsoftheadministrativeagencyorexecutiveofficerthatleadtothe

filingofalawsuitandanadjudicationbyacourtarenotthoughtofasfindings

anddonotmandatefinalaction;aremedy(discretionaryormandatory)is

contingentontheultimatefindingofthecourt.

Thesameistypicallytrueofadministrativeprocesses.Commonly,an

agencyseekingtotakeactionadversetotheinterestsofanaffectedpartybringsa

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chargethatleadstoahearingprocess;onlyafterthehearingdoesthefinal

agencyactionresultinformalfindingsandaresultantorder.21Thegovernments

interpretationofthestatuteandtheregulationsithasissuedthatimplementit

isessentiallyconsistentwiththismodel.Theplaintiffsinterpretationdeparts

fromit,byinsistingthatapreliminaryconclusionsufficienttotriggerafulldress

hearingshouldbetreatedasanagencyfindingthatmandatesaction.

Fourth,interpretingthestatutetomandateactionuponafindingthatis

nottheresultoftherequiredhearingpresentstheproblemofidentifyingwhen

andhowsuchafindinghasbeenmade.Undertheplaintiffsinterpretation,the

findingthatwouldtriggerthesemandatoryconsequencesisnot,asinthe

normalunderstandingofanagencyfinding,aformaldecisionembodiedin

documentaryform.Themostplausibleplacetolookforaformalfindingthat

precedesandthereforecouldtriggerahearingundertheplaintiffsinterpretation

isintheNOOHsissuedbytheCVMin1977whichsetforththescientific

21 Totakeonlyoneexampleofthisfamiliarprocess,whentheSecuritiesandExchangeCommissionseekstoimposeaceaseanddesistorderagainstacorporationforviolatingSection21CoftheSecuritiesExchangeActof1934,theCommissionsstaffissuesanoticeofahearingpriortotheissuanceofsuchanorder.ItisthefinaldecisionoftheCommission,notthechargescontainedinthenotice,thatconstitutethefindingsoftheagency,leadtotheissuanceoftheorder,andtriggerjudicialreview.

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conclusionsoftheDirectorregardingthesafetyissuesaffectinganimalantibiotics

andinitiatetheprocessbywhichtheagencycanwithdrawapprovaloftheir

subtherapeuticuse.

ButiftheNOOHscontainorembodythefindingsonwhichplaintiffsrely,

plaintiffsareconfrontedwiththeproblemthatthoseNOOHshavebeen

withdrawn.NothinginthestatuteorregulationsexplicitlyrestrictstheFDAs

abilitytowithdrawanNOOHafterithasissued.Thus,atthismoment,thereis

nooperativedocumentthatcontainsanyformalfinding,finalorpreliminary,

thatanyuseofanimalantibioticsposehealththreatstohumans.Accordingly,

theplaintiffsmust,anddo,arguethatthewithdrawaloftheNOOHsdoesnot

effectivelywithdrawthefindingthatwasdocumentedinthem.Theyreasonthat

findingsneednotbereflectedinanyonedocumentbutrathercomprisethe

FDAsconsideredcollectivejudgmentaboutthescienceunderlyingantibiotic

resistanceanditseffectsonhumansafety.Towithdrawthefindings,plaintiffs

argue,theFDAmustpubliclyrecantitsearlierpositiononthesafetyoftheuseof

antibioticsinanimalfeed.Accordingtoplaintiffs,theagencyscontinued

insistence,uptoandincludinginbriefingandoralargumentonthisappeal,that

suchuseofantibioticsdoesposerisksforhumansactuallyreaffirmedthe

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findingsfirstannouncedinthe1977NOOHs.Inshort,thefindingthat

subtherapeuticusesofantibioticsinanimalfeedisnotshowntobesaferesides

notinanyformallegalconclusionbutinthescientificjudgmentoftherelevant

FDAofficials,currentandpast,thatsuchusesmaybedangerous.Bythe

plaintiffsargument,oncetheSecretaryreachesaconclusionthatadruguseis

notshowntobesafe,sheisrequiredtoactonthatopinion.

ThewithdrawaloftheNOOHs,however,simplymakesmorestarka

probleminherentintheplaintiffsargument.Theunderlyinglogicofthe

plaintiffspositionisthatthefindingoftheSecretarythattriggersahearingmust

precedeeventheNOOHitself,foritisthisfindingthattriggerstheobligationof

theFDAtoholdahearingthat,assumingthatitresultsinyetanotherfinding

adversetothedrug,istheprecursortoamandatoryorderwithholdingapproval

ofthedrug.Inotherwords,oncetheSecretaryreachesacertainconclusion,an

NOOHmustissue,andahearingmustcommence.

Thatinterpretationisproblematic.Administrativefindings,whetheror

notprecededbyadversarialevidentiaryhearings,areordinarilyclothedinthe

garbofdecision,andreflectaformaldetermination.Thefactthatplaintiffsargue

thatthefindingsoriginatedwiththe1977NOOHsunderscoresthatconclusion,

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sincetheNOOHshavethelevelofformalitywetypicallyexpectfindingstohave.

ButiftheNOOHsembody(orcontain)therequisitefindings,andrevocationof

theNOOHsdoesnotsufficetowithdrawthem,wheredothefindingsexist?In

thethoughtsandbeliefsoftheSecretaryorCommissioner?Scatteredacross

variousagencydocumentsreflectingsuchthoughts?

Thatisnotmerelyaformalormetaphysicalpoint,butanintensely

practicalone.Bythelanguageofthestatute,onceafindingismade,agency

actionismandatory,andindefaultofthataction,thecourtsmaycompelthe

agencytoact.Underthegovernmentsinterpretationofthestatute,themandate

thatthecourtsaretoenforceisstraightforward.If,afterholdingahearingand

reviewingtheevidencepresented,theagencyformallyfindsthataparticularuse

ofananimaldrughasnotbeenshowntobesafeforhumans,butfailsto

withdrawapprovaloftheuseofthatdrugandinsteadadoptssomeother

approachfordealingwiththeprospectivedanger,thecourtsmustenforcethe

congressionalmandateandrequiretheSecretarytowithdrawapproval.22

22Moreover,upontheissuanceoffindingsfororagainstthedemonstrationofthesafetyofthedrugattheconclusionofahearing,judicialreviewofwhetherthefindingsareadequatelysupportedbytherecordwillbeavailable.

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Undertheplaintiffsinterpretation,incontrast,thecourtsmustfirst

determinewhetheranentirelysubjectiveandunexpressedfindinghasbeen

madeduringinternalagencydeliberations.Onthefactsofthiscase,plaintiffs

wouldhaveusseeksuchafindinginthenowwithdrawn1977NOOH,and

wouldhaveusconcludethatthefindingcontinuestoexistbasedonvarious

statementsofFDArepresentativesinpublicandbeforetheCongress,in

litigation,andintheactionstakenbytheFDAtoencouragevoluntaryreductions

inanimalantibioticuse.Thatisitselfsufficientlyproblematic,butinprinciple

plaintiffspositionwouldpermitlawsuitscontendingthattheSecretaryorher

delegateshaveactuallymadefindingsthatremainentirelyunexpressedinany

formaldocument,becausetheyhaveformedopinionsbasedoninternalagency

deliberationsoronareviewofscientificstudies.23

23 ThedissentdisavowsanyrelianceonthesubjectiveviewsofFDAofficials(Dissentingopinion,post,at2425),butthenfallsbackonessentiallythesameargumentaboutwhattheagencyreallybelievesbyarguingthatthenowwithdrawnNOOHsweremerelythemediumforthemessagetheycontained:thepriorinternalagencyconclusionsthatpenicillinandtetracyclinehadnotafterallbeenshowntobesafe(Dissentingopinion,post,at2526).Thedissentconcludesthatwithdrawaloftheformaldocumentonwhichitreliesasabasisforjudicialreviewisinsufficientunlesstheagencyhasactuallychangeditsmind,anddeducesfromavarietyofsourcesthatithasnot.

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Fifth,thetraditionalmodelofenforcementactiondescribedabove

contemplatesconsiderablediscretiononthepartofanagencytodecide,for

prudentialreasons,whethertoinitiateactionornot,andwhethertodesistfrom

proceedingbeforeafinalconclusionisreached.Suchdiscretionisatypicaland

oftennecessaryfeatureoftheadministrativeprocess.Agencieshavemany

responsibilities,andlimitedresources.Decidingwhetherandwhentodeploy

thoseresourcesinanarduous,contestedadversarialprocessisanimportantand

difficultresponsibility.Itisrarethatagencieslackdiscretiontochoosetheirown

enforcementpriorities.Indeed,theSupremeCourthaslongapplieda

presumptionagainstjudicialreviewofagencydecisionsdecliningtoproceed

withenforcementactionsbecausesuchdecisionsare,forpurposesofthe

AdministrativeProcedureAct(APA),committedtoagencydiscretion.

Hecklerv.Chaney,470U.S.821,83233(1985),quoting5U.S.C.701(a)(2).

Plaintiffsinterpretationof360b(e)(1)woulddenythatdiscretiontothe

FDA.Werethefindingthatrequiresthewithdrawalofapprovallocatednotin

thefinaldecisionoftheCommissionerattheconclusionofahearingatwhichall

relevantevidenceispubliclypresented,butinadeterminationbytheheadofthe

CVM,basedonaninternalconsiderationofstudiesconductedbytheagencyor

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intheacademicliterature,thatthescientificevidencewarrantsinitiatinga

hearingsothattheCommissionermighteventuallyreachsuchafinaldecision,

theagencywouldberequiredtotakeirrevocableactionwhenevertheCVM

formssuchanopinionthatadrugisnotshowntobesafe,regardlessofwhether

theFDAbelievesthatproceedingfurtherisworththediversionofresourcesfrom

otheragencypriorities.Ordinarily,administrativediscretionisatitszenithwhen

anagencydecideswhethertoinitiateenforcementproceedings.The

governmentspositionisconsistentwiththislongstandingdiscretion;the

plaintiffspositionisnot.

Incanvassingthesevariousprinciplesandpractices,wedonotsuggest

thattheyaremandatoryandinescapablepresumptionsaboutadministrativelaw.

Administrativeprocedureisflexible,anddifferentapproachesmaybe

appropriateindifferentcontexts.Wehavepointedtowhatwebelievearethe

morecommonunderstandingsorexpectationsaboutagencyfindings,orderly

procedure,administrativediscretion,andjudicialreview.Weareconfidentthat

numerousexceptionsandcounterexamplesexist.Moreimportantly,itis

beyonddoubtthatCongresshasthepowertoaltertheseassumptions,inany

particularcaseoringeneral,byadoptinglegislationthatimposescontrary

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mandatesonadministrativeagencies.24Moreover,giventhepreeminent

importanceofhealthandsafetyintheusageofpowerfulbioactivesubstances

suchashumanandanimaldrugs,itwouldhardlybesurprisingforCongressto

imposelimitsontraditionalagencydiscretionortomandateactionsprotectiveof

humansafety.ButtheissuehereisnotwhetherCongresscanimposethesortof

mandateplaintiffswouldfindinthestatuteofcourseitcanbutwhether

Congresshasdoneso.

E. Summary

Oursurveyofthetext,thecontext,theregulations,andthebackground

legalprinciplesleaveusfirmlypersuadedthatCongresshasnotrequiredthe

FDAtoholdhearingswheneverFDAofficialshavescientificconcernsaboutthe

safetyofanimaldrugusage,thattheFDAretainsthediscretiontoinstituteor

24 SuchwasthesituationintherecentlydecidedCookv.FDA,733F.3d1(D.C.Cir.2013).There,theD.C.CircuitfoundtheFDAfailedtoenforceastatutethatincludedaclearCongressionalmandatefortheFDAtotakeactioninparticularcircumstances.TheFDAarguedthatbecauseenforcementisamatterofagencydiscretion,thedecisiontonotenforcethestatutewasnotsubjecttojudicialreview.Id.at5.ThecourtfoundtherelevantstatutetobeunambiguouslybindingontheFDAinmandatingthatparticularactionsbetaken.Id.at7(citationomitted).Thus,thecaseaddressedaninstanceofexplicitlegislativeinstructionstrippinganagencyofdiscretion.Suchclearlegislativeinstructionisnoticeablyabsenthere.

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terminateproceedingstowithdrawapprovalofanimaldrugsbyissuingor

withdrawingNOOHs,andthatthestatutorymandatecontainedin360b(e)(1)

appliestolimittheFDAsremedialdiscretionbyrequiringwithdrawalof

approvalofanimaldrugsorparticularusesofsuchdrugsonlywhentheFDA

hasmadeafinaldetermination,afternoticeandhearing,thatthedrugcould

poseathreattohumanhealthandsafety.

Thatconclusionbegins,asitmust,withthetextofthestatute.Although

thetextisnotunambiguouslyclear,webelievethattheFDAputforththemore

naturalreading.ThestatuterequirestheFDAtowithdrawapprovalofan

animaldrugonlyafterduenoticeandopportunityforhearinghasbeen

afforded,andthenonlyiftheSecretaryfindsthatthedrugisnotshowntobe

safe.21U.S.C.360B(e)(1).Thatlanguagemostnaturallyreferstoafindingthat

isissuedasaresultofthehearing.Thatinterpretation,moreover,avoids

injectingasecond,unexpressedfindingintothesequenceofeventsmentioned

inthestatute.

Althoughtheregulationsimplementingthestatutedonotdirectlyaddress

thequestionofinterpretationposedbytheplaintiffs,andcontainatleastsome

languagethatarguablysupportstheplaintiffsreadingofsometermsinthe

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statute,theoverallthrustoftheregulationsisconsistentwiththegovernments

interpretation,andwithwhatweregardasthemorenaturalreadingofthe

statutorylanguage.Moreover,theproceduresetforthinthoseregulations,and

ourreadingofthetext,areconsistentwithcommonassumptionsaboutagency

procedure.Underthatprocedure,relevantexpertswithintheagency(thestaffof

theCVM)firstassessthescientificissuesregardingtherisksandbenefitsofthe

drug,andahighrankingagencyofficial(theDirectoroftheCVM)exercises

discretiontoinstituteaproceedingthatcanleadtotherevocationofapprovalof

thedrug.Then(ifthesponsorofthedrugrequestsahearingandraisesgenuine

issuesofmaterialfactaboutthepreliminaryconclusionssetforthintheNOOH)

thestaffproceedstopresentevidenceatahearingfeaturingtheseparationof

functionsbetweentheprosecutingofficialsinstitutingthehearingandthe

objectivedecisionmakerwhowillheartheevidence.Attheconclusionofthat

hearing,thatdecisionmakerissuesfindingsthatmustbeapprovedbyahigher

rankingofficial,theCommissioneroftheFDA.Iftheultimateagencyfinding,

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whichissubjecttojudicialreview,isthatthedrugisnotshowntobesafe,the

statutepermitsonlyoneremedywithdrawalofapproval.25

Ourinterpretationofthestatuteisconsistentwiththeregulationsandwith

conventionalprocedure.Thatalonedoesnotmakeitcorrect;Congress

undoubtedlyhasthepowertoalterthoseconventions.Webelieve,however,that

ifCongressintendedtodoso,andtomandatethecommencementofthenotice

andhearingprocesswhenevertheagencystaffformedascientificopinion

adversetothedrug,itwouldhavestatedthoseintentionsexplicitly.Farfrom

doingso,ithasutilizedlanguagethatisnotonlyconsistentwiththetraditional

administrativeprocess,butthatismorenaturallyreadasadoptingit.

II. TheCitizenPetitions

Alternatively,plaintiffsarguethateveniftheFDAisnotrequiredto

proceedwithhearings,itsdecisiondenyingplaintiffs1999and2005citizen

petitionsandwithdrawingthe1977NOOHsrepresentedarbitraryorcapricious

agencyactioninviolationoftheAPA.See5U.S.C.706(2)(A).Inparticular,

25 Ourreadingthusemphaticallyrecognizesthemandatorylanguageofthestatute.WheretheFDAwouldotherwisehaveconsiderablediscretiontotakewhateveractionmightbeappropriatetoprotectthepublicsafetyinlightoftheresultsofthehearing,Congresshasspecificallymandatedin360b(e)(1)thatonlyoneresponseisappropriate.

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plaintiffsarguethattheFDAsdenialswerebasedonfactorsnotexplicitly

mentionedbythestatute,namelycost,time,andapreferenceforvoluntary

complianceoveradversaryproceedings.

TheFDAsnoticewithdrawingthe1977NOOHssetsoutthereasonsfor

theaction:

FDAistakingthisaction,andclosingthecorrespondingdockets,because:FDAisengaginginotherongoingregulatorystrategiesdevelopedsincethepublicationofthe1977NOOHswithrespecttoaddressingmicrobialfoodsafetyissues;FDAwouldupdatetheNOOHstoreflectcurrentdata,information,andpoliciesif,inthefuture,itdecidestomoveforwardwithwithdrawaloftheapprovedusesofthenewanimaldrugsdescribedintheNOOHs;andFDAwouldneedtoprioritizeanywithdrawalproceedings(forexample,takeintoaccountwhichwithdrawal(s)wouldlikelyhavethemostsignificantimpactonthepublichealth)if,inthefuture,itdecidestoseekwithdrawaloftheapprovedusesofanynewanimaldrugorclassofdrugs.

WithdrawalofNoticesofOpportunityforaHearing:PenicillinandTetracycline

UsedinAnimalFeed,76Fed.Reg.79697,79697(Dec.22,2011).Thelettersin

whichtheFDAfinallydeniedofthecitizenpetitionsfurtherelaborateonthe

decisiontowithdrawtheNOOHSanddenythepetitions,statingreviewing

safetyinformationforantimicrobialdrugsapprovedbefore2003,andpursuing

withdrawalproceedingsinsomecases,wouldtakemanyyearsandwould

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imposesignificantresourcedemandsonthe[FDA].J.A.at622;J.A.at627.In

theletterstheFDAdescribesitsplantowork[]cooperativelywiththeanimal

pharmaceuticalindustrytoensur[e]thejudicioususeofmedicallyimportant

antimicrobialdrugsinfoodproducinganimals.Id.

Inarguingthatsuchdenialisarbitraryorcapricious,plaintiffsclaimthat

theFDAignoredthereamsofscientificdatapresentedinthepetitionsandthat

thereasonsgivenbytheFDAareillegitimatebecausetheyareorthogonalto

whatplaintiffspersuadedthedistrictcourtisthegoverningcriteriondescribedin

thestatute:whetherthedrugsatissueposeathreattohumanhealth.See

NRDCII,872F.Supp.2dat338.

PlaintiffsarguethatthiscaseisbestanalogizedtoMassachusettsv.EPA,

549U.S.497(2007),inwhichtheSupremeCourtinvalidatedthedenialofa

petitionseekingtorequiretheEnvironmentalProtectionAgency(EPA)to

regulategreenhousegases.ButMassachusettsdealtwithamuchdifferent

statutoryprovision,onewhichunambiguouslycompelledagencyaction.Inthat

case,agroupofstates,municipalities,andnonprofitorganizationssoughtto

forcetheEPAtoregulatefourgreenhousegasesasairpollutantsunderSection

202(a)(1)oftheClearAirAct,whichprovidesthat:

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The[EPA]Administratorshallbyregulationprescribe...standardsapplicabletotheemissionofanyairpollutantfromanyclassorclassesofnewmotorvehiclesornewmotorvehicleengines,whichinhisjudgmentcause,orcontributeto,airpollutionwhichmayreasonablybeanticipatedtoendangerpublichealthorwelfare.

42U.S.C.7521(a)(1)(emphasisadded).TheSupremeCourtagreedwith

theplaintiffsthatthetextoftheCleanAirActrequiredtheEPAtoregulate

greenhousegases.Inreachingthatconclusion,theCourtunderstoodthe

judgmentcontemplatedbythestatuteaslimitedtothescientificquestion

whetheraparticularpollutantcontributedtoairpollution.Putdifferently,the

SupremeCourtreadtheCleanAirActnottogranttheEPAdiscretiontochoose

toregulateonlythosepollutantsthatitdeemedfeasibleorwisetoregulate.As

theCourthadit,theuseofthewordjudgmentisnotarovinglicensetoignore

thestatutorytext.Massachusetts,549U.S.at533.OncetheEPAdetermined

thatcarbondioxidecontributedtoairpollution,theCourtconcluded,thestatute

requiredittoregulatetheemissionofthatgas.

Massachusettsv.EPAisthereforefullydistinguishablefromthepresent

case.TheCleanAirActlimitedtheEPAAdministratorsjudgmenttothe

scientificquestionofwhetherthepollutantinquestioncausesdangerousair

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pollution;nothingin360b(e)(1)limitstheconsiderationsthattheFDAmaytake

intoaccountindecidingwhethertoinitiatethehearingprocessbyissuingan

NOOH.Moreover,unliketheCleanAirAct,whichexplicitlyand

unambiguouslyrequirestheregulationofpollutants(TheAdministratorshallby

regulationprescribe...standards),asexplainedabove,360b(e)(1)doesnot

mandatethattheFDAtakeanyactionuntilandunlesscertainfindingsaremade

afterahearing.26Inshort,theCleanAirActprovisionatissueinMassachusetts

v.EPAunambiguouslyrequiredtheEPAtoundertakeactiontocreateemission

standards(leavingittotheEPAsexpertisetodeterminethesubstanceofthe

standards)wheneveritformsascientificjudgmentthataparticularpollutant

contributestodangerousairpollution,whiletheprovisionoftheFDCAatissue

inthiscaserequirestheFDAtotakeaspecificremedialstepwhen,aftera

26PlaintiffsrelianceonBrown&Williamsonisalsomisplaced.Inthatcase,theSupremeCourtheldthattheFDAlackedstatutoryauthoritytoregulatethesaleoftobaccoproducts.529U.S.at12526.Inthecourseofitsanalysis,theCourtnotedthatifithadstatutoryjurisdictiontoregulatetobaccoproducts,FDAwouldhavebeenrequiredbyitsorganicstatutetoremovethemfromthemarketaltogether.Id.at13536.Therewasnoquestioninthatcase,however,thatFDAhadmadefindingsaboutthesafetyoftobaccobeforeissuingafinalrulegoverningyouthaccesstotobaccoproducts.TheSupremeCourtdidnotaddresswhether,iftobaccofellwithinitsjurisdiction,theFDAwouldhavebeenrequiredtoinitiate,orforbiddenfromabandoning,acourseofhearingsthatmightormightnothaveresultedinsuchfindings.

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hearing,ithasmadecertainfindings,withoutimposinganyabsolute

requirementthattheagencyinvestigatetheneedforwithdrawingapprovalof

animaldrugsunderanyparticularcircumstance.

ThepresentcaseisthereforemoreanalogoustoNewYorkPublicInterest

ResearchGroupv.Whitman,321F.3d316(2dCir.2003),inwhichweinterpreted

section502(i)oftheCleanAirAct,42U.S.C.7661a(i)(1).Thatprovision

requiredtheAdministratoroftheEPAtogivenoticeand,ifappropriate,impose

therelevantsanctions,[w]henevertheAdministratormakesadeterminationthat

apermittingauthorityisnotadequatelyadministeringandenforcingaprogram.

..inaccordancewiththerequirementsofthissubchapter.Id.(emphasisadded)

Weheldthattheuseoftheworddeterminationgrantsdiscretion.Whitman,

321F.3dat330.RejectingtheviewthattheEPAwasrequiredtoissueanoticeof

deficiencywheneveritfounddefectsinastatepermittingprogram,wenoted

thatCongresscouldhavefashionedaregimeunderwhich,forexample,an

interestedpartycouldinitiatetheprocessleadingtoadeterminationofwhether

apermittingauthorityisadequatelyadministeringandenforcingaprogram,

butthatbyreferringtoadeterminationonthepartoftheagency,Congressleft

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ittothediscretionoftheEPAAdministratorwhetherandwhentoinitiate

enforcementproceedings.Id.at331,quoting42U.S.C.7661a(i)(1).27

Forthereasonssetforthabove,weconcludethatthedecisionwhetherto

instituteorterminateahearingprocessthatmayleadtoafindingrequiring

withdrawalofapprovalforananimaldrugisadiscretionarydeterminationleft

totheprudentchoiceoftheFDA.28

Onthatbasis,itisrelativelyeasyforustoaccepttheFDAsdetermination

thatitspreferredprogramofvoluntarycomplianceoffersgreaterprospectfor

immediateandsignificantreductionsinanimalantibioticusethanthepursuitof

27 Asfurtherevidenceoftheabsenceofastatutorymandate,wenotedthelackofanytimestatutorytimelimitsontheagencysaction,321F.3dat331n.8,afactoralsoapplicablehere.

28 WerespectfullydisagreewithJudgeKatzmannsassertion(Dissentingopinion,post,at32)thatbecausewefindWhitmantoofferahelpfulanalogytodeterminewhethertheFDAabuseditsdiscretion,weareimplicitlyequatingawithdrawalactiontoanenforcementaction.Whitmanprovidesguidanceinthattherelevantstatutorylanguageinthatcase(WhenevertheAdministratormakesadetermination,321F.3dat330,quoting42U.S.C.7661(a)(i)(1))leftthemandatoryagencyactionconditionaluponadiscretionaryagencyfinding,muchlikethestatutoryprovisionatissuehere(actionisrequiredonlyiftheSecretaryfindsthatcertainconditionsadhere).Therelevantparallelinthesecasesisoneofanalogicalstatutoryconstructionthatleavesactiondependentuponagencydiscretion,aconstructiondistinguishablefromtheunequivocalimperativeinthestatuteatissueinMassachusettsv.EPA.Whetherawithdrawalactionisanenforcementactionisnotrelevanttoourconclusion.

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apotentiallycontentiouswithdrawalhearing.Thatisthesortofprudential

judgmentbettersuitedtoexpertadministratorsthantofederaljudges.Weare

bolsteredinthisconclusionbythenatureoftheproblemconfrontedbytheFDA.

NothingintheNOOHssuggeststhatpenicillinandtetracycline,when

administeredtoanimals,areinherentlydangeroustohumanhealth;such

antibioticsarewidely,effectively,andbeneficiallyusedinhumanmedicalcare.

Andwhilewearehesitant,forthereasonssetforthabove,toascribescientific

conclusionstotheFDAbasedonourreadingofamelangeofdifferentstudies,

regulatorydocuments,andlitigationpositions,itappearsclearthatwhilethe

agencyregardstheindiscriminateandextensiveuseofsuchdrugsinanimalfeed

asthreatening,itdoesnotnecessarilybelievethattheadministrationof

antibioticstoanimalsintheirfeedisinherentlydangeroustohumanhealth.

Underthesecircumstances,wecannotconcludethatitisarbitraryor

capriciousfortheFDAtopursuepolicesintendedtoreducetheuseofanimal

feedcontainingantibioticsthroughavarietyofstepsshortofwithdrawing

approvalfortheuseofantibioticsinfeedviaaprotractedadministrativeprocess

andlikelylitigation.AsitwasneitherarbitrarynorcapriciousfortheFDAto

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denythepetitionsforthereasonsitdid,thedistrictcourtsdecisiontothe

contrarywaserror.

InlettersrecentlysubmittedtotheCourtbythegovernment,the

governmentnotesthattheFDAisencouragedbytheoverwhelmingly

cooperativereactionoftheanimalfeedindustrytotheguidelinesforvoluntary

compliancethattheagencyhasissuedinlieuofproceedingwiththeprocess

initiatedin1977withtheissuanceofthePenicillinandTetracyclineNOOHs,

GovtLetterdatedMarch27,2014,andassertsthatthehighlevelofcooperation

bydrugmanufacturersdemonstrate[s]thatthecooperativeapproach...has

beeneffectiveinenablingFDAtoachieveitsgoalsofphasingouttheuseof

medicallyimportantantimicrobialdrugsforfoodproductionpurposes,Govt

LetterDatedJuly1,2014.Inlightofthediscussionabove,itshouldbeobvious

thatweexpressnoopinionontheeffectivenessoftheFDAsapproachtowhatit

agreesisasignificantregulatoryconcernabouttheoveruseofantibioticsin

animalfeed,andthatindeterminingtheissuesinthiscase,weplacenoweight

ontheagencysinformalassurancesthatitsprogramissuccessful.Itisnotforus

todeterminewhethertheagencyhasbeenprudentorimprudent,wiseorfoolish,

effectiveorineffectiveinitsapproachtothisproblem.Whethertheagencyslong

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inactioninthefaceofthedangershighlightedinthe1977NOOHsrepresented

politicallyinspiredfootdraggingorwisecautionindevelopingacosteffective

approach,itwasfortheagency,andnotthecourts,todeterminehowbestto

proceed.

CONCLUSION

Fortheforegoingreasons,thedecisionsofthedistrictcourtare

REVERSED,andthecaseisremandedtothedistrictcourtwithinstructionsto

denytheplaintiffsmotionforsummaryjudgment,grantthedefendantsmotion

forsummaryjudgment,anddismisstheaction.

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