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.
1
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page1 of 65
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.
2
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page2 of 65
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).
3
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page3 of 65
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
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page4 of 65
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.
5
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page5 of 65
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
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page6 of 65
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.
7
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page7 of 65
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,
8
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page8 of 65
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
9
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page9 of 65
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
10
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page10 of 65
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
11
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page11 of 65
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.
12
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page12 of 65
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.
13
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page13 of 65
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.
14
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page14 of 65
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.
15
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page15 of 65
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
16
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page16 of 65
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.
17
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page17 of 65
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.
18
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page18 of 65
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
19
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page19 of 65
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.
20
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page20 of 65
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.
21
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page21 of 65
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
22
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page22 of 65
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
23
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page23 of 65
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.
24
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page24 of 65
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.
25
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page25 of 65
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,
26
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page26 of 65
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,
27
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page27 of 65
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
28
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page28 of 65
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).
29
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page29 of 65
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
30
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page30 of 65
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
31
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page31 of 65
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.
32
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page32 of 65
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.
33
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page33 of 65
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.).
34
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page34 of 65
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
35
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page35 of 65
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
36
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page36 of 65
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
37
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page37 of 65
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
38
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page38 of 65
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
39
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page39 of 65
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
40
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page40 of 65
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.
41
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page41 of 65
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
42
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page42 of 65
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.
43
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page43 of 65
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
44
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page44 of 65
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
45
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page45 of 65
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.
46
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page46 of 65
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
47
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page47 of 65
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,
48
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page48 of 65
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.
49
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page49 of 65
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.
50
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page50 of 65
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
51
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page51 of 65
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
52
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page52 of 65
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.
53
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page53 of 65
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
54
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page54 of 65
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,
55
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page55 of 65
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.
56
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page56 of 65
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
57
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page57 of 65
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:
58
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page58 of 65
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
59
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page59 of 65
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.
60
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page60 of 65
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
61
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page61 of 65
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.
62
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page62 of 65
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
63
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page63 of 65
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
64
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page64 of 65
inactioninthefaceofthedangershighlightedinthe1977NOOHsrepresented
politicallyinspiredfootdraggingorwisecautionindevelopingacosteffective
approach,itwasfortheagency,andnotthecourts,todeterminehowbestto
proceed.
CONCLUSION
Fortheforegoingreasons,thedecisionsofthedistrictcourtare
REVERSED,andthecaseisremandedtothedistrictcourtwithinstructionsto
denytheplaintiffsmotionforsummaryjudgment,grantthedefendantsmotion
forsummaryjudgment,anddismisstheaction.
65
Case 12-2106, Document 165-1, 07/24/2014, 1278159, Page65 of 65
Top Related