OregonTilth
CertifiedOrganic
Procedures Manual
May30,2017
Published by:
Oregon Tilth, Inc.
2525 SE 3rd Street
Corvallis OR 97333
(503) 378-0690, Fax (503) 753-4924
Table of Contents
Part I: Introduction & Overview
A. Welcome To Oregon Tilth ...........................................................................................3
B. Philosophy of Oregon Tilth .........................................................................................3
C. Overview of the Certification Program ......................................................................3
D. Administration of the Program ...................................................................................4
E. Scope of Certification Services .....................................................................................5
F. Accreditation ..................................................................................................................7
G. Enforcement ..................................................................................................................9
Part II: Procedures
A. Requesting a Certification Packet ...............................................................................9
B. Applying for Certification ............................................................................................9
C. The On-Site Inspection ...............................................................................................10
D. The Decision-Making Process ....................................................................................14
E. Withdrawal of the Application ..................................................................................15
F. Acknowledgment of Certification ..............................................................................15
G. Continuation of Certification.....................................................................................15
H. Product Adjustment ...................................................................................................16
Part III: Procedures for Certification of Multi-Site Operations
A. Inspections of Multi-Site Operations.........................................................................17
B. Requirements and Procedures for Multi-Site Operations.......................................17
Part IV: Procedures Related to Transitional Certification ..................................................................... 19
Part V: Procedures Regarding Confidential Information....................................................................... 20
Part VI: Enforcement and Adverse Action ...............................................................................21
Part VII: Appeals and Mediation ............................................................................................24
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PART1:INTRODUCTIONTOOREGONTILTHANDANOVERVIEWOFTHEOREGONTILTH
CERTIFIEDORGANIC(OTCO)PROGRAM
A.WELCOMETOOREGONTILTH
OregonTilth,Incisanonprofitorganizationthatsupportsandpromotesbiologicallysoundand
sociallyequitableagriculturethrougheducation,research,advocacyandproductcertification.
Tilthbeganin1973asanagriculturalorganization,whichhascultivatedauniqueurban-rural
outlook.
OregonTilthisbestknownforitsdevelopmentofanorganiccertificationprogram,whichis
detailedinthismanual.Wecoordinateconferences,produceeventsinlocalcommunities,and
makespresentationsatconferences,educationalworkshopsandtradeshows.Abi-monthly
magazine,InGoodTilth,keepsthepublicinformedabouttheactivitiesofOregonTilthaswell
asissuesofinteresttothecommunityoforganicproducers,handlers,processors,and
consumers.OurEducationprogrammingincludesanOrganicConservationProgramand
educationofconsumersaboutthebenefitsoforganicagricultureandgardening.OregonTilth
enjoysa501(c)(3)tax-exemptcharitablestatus.
AlthoughmanycertifiedoperatorsareactivemembersofOregonTilth,membershipisnot
requiredforOTCOcertification.
B.PHILOSOPHYOFOREGONTILTH
OregonTilthadvocatesaholisticapproachtoagriculturalproductionsystems.OregonTilth
encouragesgrowerstocreatefarmsystems,whichimprovesoilsandrequireminimal
interventionforpestcontrol.Tilthfavorstheuseofnaturalslow-releasefertilizersand
compost,whichemulatethenaturalprocessesofsoilformation.Tilthstressespreventionof
pestproblemsthroughtheuseofcroprotations,beneficialinsectsandfieldsanitation.
However,whenpestcontrolisnecessary,Tilthurgesgrowerstousenon-toxicmethods,leaving
thestrictlylimitedpesticides,whichareavailabletoorganicgrowers,tobeusedonlywhen
necessarytopreventcroploss.
InordertoensuretheorganicintegrityofproductsfromthefarmtothetableOregonTilth
workswithprocessors,handlers,andmarketersoforganicproducts.Organicstandardsfor
operationshandlingandprocessingorganicproductsemphasizetheimportanceofprevention
ofcontaminationand/orcominglingwithnon-organicproductsthroughoutthehandling
process.Facilitypestmanagementmethodsmustusetheleasttoxicpracticespossibleto
successfullymanagepests.Detailedrecordsandaudittrailsprovidethedocumentation
necessaryforverificationofproperattentiontocriticalcontrolpoints.
C.OVERVIEWOFTHEOTCOCERTIFICATIONBODY
Thepurposeoforganiccertificationistoensurethattheagreed-uponconventionsoforganic
managementsystemsarebeingpracticednotonlybygrowers,butalsobyallthepeoplewho
handleandprocessorganicfoodonitsjourneytothefinalconsumer.ToaccomplishthisOTCO
implementsasystemthatcombinesstrictproductionstandards,verifiablethirdparty
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inspectionsandlegallybindingcontracts,whichprotecttheproducersandbuyersoforganic
products.
Organiccertificationverifiesthatoperationshaveimplementedorganicproductionsystems
thatcomplywithestablishedstandards.Organiccertificationisnotafinalproductguarantee
regardingabsenceofresidualenvironmentalcontaminants.
OTCOisspecificallydesignedasacertificationservicefor:
• Producersoforganiccropsandlivestock,
• Wildharvestoforganiccrops
• Processorsoforganicfoods,
• Handlersoforganicfoodssuchaspackers,brokers,distributors,andwholesalersand
• RestaurantsandRetailers
• FiberandTextiles,includingChemicalInputApprovals
• PersonalCareProducts
OTCOoperatesinanon-discriminatorymanner.OTCOmakesitscertificationservicesaccessible
toallapplicantswhoseactivitiesfallwithinthescopeofitsoperations.Proceduresarenotbe
usedtoimpedeorinhibitaccessbyapplicants,otherthanasprovidedinthismanual.Accessto
thecertificationprocessisnotconditionaluponthesizeoftheclientormembershipofany
associationorgroup;includingOregonTilth,noriscertificationbeconditionaluponthenumber
ofcertificationsalreadyissued.ThereisnounduefinancialorotherconditionsnorisOregon
Tilthfinanciallydependentonsingleoperationsthataresubjecttoitscertificationinanyway
thatcompromisesitsimpartiality.ParticularlyfortheGOTSprogram,OregonTilthacceptsGOTS
inspectionassignmentsregardlesswhethertheyarefortheentireprocessingchain,parts
thereoforsingleoperators.
D.ADMINISTRATIONOFTHEPROGRAM
ThemainOregonTilthadministrativeofficeislocatedinCorvallis,OregonandisopenMonday
throughFriday,from9amto5:00pmPacificTime.Youmaycontacttheofficeatthefollowing
address:
OregonTilth.2525SE3rdStreet,CorvallisOR97333
Phonenumber:(503)378-0690,Faxnumber:(541)753-4924
E-mail:[email protected],Website:www.tilth.org
Thereisaphoneansweringmachineavailablewhentheofficeisclosed.Staffclearsmessages
eachbusinessdayandreturnscallsassoonaspossible.Bycontactingthemainadministrative
office,youwillbedirectedtotheappropriatepersonnel.
OTCOPersonnel
ThedailyworkofcertificationismanagedbytheCertificationDirectorandimplementedby
certificationstaff,withadditionalsupportprovidedbyadministrativestaff.OTCOsometimes
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hiresinspectorsonacontractualbasisandusesothercontractworkerstoworkonspecific
projects.Whenevercontractservicesareutilizedduringthecertificationprocess,OTCOretains
finalauthorityandresponsibilityforallcertificationdecisions.
FinancialSupportfortheCertificationProgram
Thecertificationprogramisaself-sustainingprogramwithinOregonTilththatalsolends
financialsupporttoOregonTilth’seducation,advocacyandresearchactivitiesthatfurther
supportandpromoteorganicagricultureandfoodsystems.TheCertificationDirector,in
consultationwiththeExecutiveDirectorandtheBoardofDirectorsaspartoftheannual
budgetingprocess,determinesthefeespaidbyapplicantsandcertifiedoperationsrequesting
certificationtoensurethatallexpensesoftheprogramarepaidinfullbytheendofeachfiscal
year.
E.SCOPEOFCERTIFICATIONSERVICES
Inresponsetotheincreasingmarketdemandoforganicproductsandqualitycertification
services,OregonTilthofferscertificationtooperatorsthroughouttheUnitedStatesand
internationally,whenitisinouradministrativecapacitytodoso.Offeringglobalcertification
servicesservestwopurposes.Itassistsdomesticproducersandprocessorswithaccessto
foreignmarkets,suchasMexico,Canada,theEuropeanUnionandJapanwhilealsoassisting
foreignproducerswithcomplianceandaccesstoUSorganicmarkets.Thiscanimprovethe
economicviabilityofproducersindevelopingcountriesbyaccessingbettermarketpremiums.
WheneverpossibleOTCOprovidestranslatedversionsofStandardsandControlledDocuments,
however,finalcertificationdecisionsarebasedontheoriginalEnglishversions.
TypesofOperations
Certificationisavailableforindividualoperationsaswellasmulti-siteoperationswith
demonstratedinternalcontrolsystem(a.k.a.cooperativesorgrowergroups).Applicationforms
havebeenadaptedtoreflecttheorganicmanagementstructureofthesedifferenttypesof
operations.
Anindividualoperationisasoleproprietorship,corporation,partnershiporsimilarlydefined
singlecompany.Asinglecertificationmaycoveractivitiesatmultiplesitesunderthedirect
managementoftheapplicantcompany.
Amulti-siteoperationwithdemonstratedinternalcontrolsystem(a.k.a.cooperativeorgrower
group)involvesacentrallymanagedassociationoflocalgrowersproducingsimilarcropsusing
similarpracticesandmarketingtheirproductsincommon.Theoperationmustbeconstituted
asalegalentityinthecountrywheretheyoperate.Asingleoperationmaycovernumerous
individualmemberfarmers.Managementmustestablishandmaintainaninternalcontrol
systemincludingaccesstoandeducationregardingorganicstandards.Managementmustalso
annuallyconductathoroughstandardscomplianceevaluationofeachmemberandfarm.
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CategoriesandClassesofCertification
OTCOprovidescertificationservicesforoperationsthatproduceincrops,livestockorhandle
organicproducts.WithineachofthesebroadcategoriesOTCOhasestablishedclassesof
certificationtoaddresstheuniqueattributesandactivitiesofeachtypeofoperation.Asingle
operationmaybecertifiedundermorethanonecategoryandclassofcertification,depending
onthescopeoftheiractivities.
CROPPRODUCTION
ClassTTransitional
ClassO
ClassOW
TransitionalagriculturalproductsfalloutsidethescopeoftheUSDANationalOrganic
Program.TransitionalstandardsarebasedupontheOrganicFoodsProductionActof
1990andtheapplicableproductionandhandlingstandardsestablishedbytheUSDA
NationalOrganicProgramunder7CFRPart205,excepttransitionalproductslack
compliancewith§205.202(b).
OrganicallyGrown.Coversfarmsproducingagriculturalandhorticulturalcrops.
OrganicWild-CropHarvest.Coversthesustainableharvestofwildcropsgrowingina
designatedareathathasbeenfreeofprohibitedmaterialsforatleast3years.
LivestockProduction
ClassOLP
OrganicallyGrownLivestockandPoultry.Coversfarmsproducinganimalproducts
suchasmeat,eggsandmilk.
HandlingOperations
ClassOH
ClassOR
ClassOFT
ClassOPC
OrganicHandlers.Coversbusinessespreparingfood,feedandprocessedproductsas
wellasthoseparticipatinginthedistributionchainfororganicfoodssuchaspackers,
brokers,wholesalers,distributorsandprivatelabelcompaniesandbrandowners.
OrganicRetailStoresandRestaurants.Coversretailstoresandrestaurantswhichsell
organicproductstotheconsumer,eitherasfreshproduce,packagedgoods,orreadyto-eatmeals.
OrganicFibersandTextiles.Coverstheprocessingandhandlingoffiberandtextile
productsundertheGlobalOrganicTextileStandards,includingchemicalinput
approvals.
OrganicPersonalCare.Coverstheprocessingandhandlingofpersonalcareproducts
undertheNSF/ANSI305Standards.
OrganicCertificationStandards
TheOTCOProgramoffersassessmentforcomplianceand/orequivalencewithseveraldifferent
organiccertificationstandards.Someareestablishedandenforcedviagovernmentregulations,
suchastheUSDANationalOrganicProgram(NOP)standards(7CFRPart205),theEuropean
OrganicProgram(EEC834/07)(assessedthroughtheACBEUEquivalenceStandard),Mexico
OrganicProgram(LPO-LeydeProductosOrganicos)andtheCanadianOrganicRegime
(COR)(CAN/CGSB32.310).Otherorganicstandardsareestablishedbyindustryworkinggroups,
suchastheGlobalOrganicTextileStandards(GOTS),theNationalCertifiedTransitional
Program(NCTP)andtheNSF/ANSI305PersonalCareProductsContainingOrganicIngredients.
Dependingonthestandards,differenttypesofproducts(i.e.food,fiber,orcosmetic/personal
care)arerequiredand/oreligibleforcomplianceassessment.
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OTCOnotifiescertifiedoperatorsofchangestostandards,criteria,regulations,directives,
memos,programhandbookupdates,exportarrangementprovisionsandnotlimitedtoany
notificationorchangethataffectsthecertificationbodyanditsoperators;including
implementationdatesforcomplianceasnecessary.OTCOwillnotifytheoperatoraccordingto
therelevantnotification;inlieuofanynotificationdeadline,OTCOwillprovidenotificationto
thoseoperatorsthatmaybeaffectedbythechangestothestandardswithin30days.Inall
casesOTCOprovidesoperatorswithnoticeandasummaryoftheactionsneededwithinthe
requiredtimeframeprovidedbythestandardsowner.
OregonTilthcurrentlyoffersthescopesoutlinedbelowwiththespecificstandard:
USDANOP
Producer,wildcrop,livestock(includingfiber),handling,
retailandrestaurant,multisiteoperations
Transitional
Producersorhandlersofproductsthatareintransition.
EU834/2007viaACBEU
ForProducersorprocessorsexportingproducttoanEU
EquivalenceStandard
memberstate
GlobalOrganicTextileStandards Fiberandtextiles,includingchemicalinputapprovals.
(GOTS)
CanadianOrganicRegime(COR) Producer,handler(includingmarketer,handler,processor),
wildcrop,livestock(includingfiber)
NSF/ANSI305
Processorsandhandlersofpersonalcareproducts,
cosmetics,oralcareandpersonalhygieneproducts
MexicoOrganicProgram(LPO– Producer,wildcrop,livestock(includingbeekeeping&
LeydeProductosOrganicos)
fiber)andhandling
F.ACCREDITATION
InNovember1999,OTCOwasevaluatedandrecognizedbytheUSDAAgriculturalMarketing
ServiceforcompliancewiththeInternationalOrganizationforStandardization(ISO)Guide65:
Generalrequirementsforbodiesoperatingproductcertificationsystems.Theprocessinvolveda
rigorousexaminationofOTCO’squalitysystemsandcertificationprocedures,inspectionof
officefilesandprocedures,assessmentofpersonnelqualificationsandobservationofon-site
inspectionsofcertifiedfarmersandprocessors.Annualaudits,includingon-sitevisitsofthe
OTCOofficeandcertifiedoperations,arepartofmaintainingongoingaccreditation.OTCOhas
alsobeenevaluatedandrecognizedbytheInternationalOrganicAgricultureMovement(IOAS)
forcompliancewiththeISO/IEC17065.
ISO/IEC17065accreditationallowseasierentryofOTCOcertifiedproductsintointernational
marketsandestablishesastrongbasisforreciprocitywithothercertificationagents.Italso
servesasatooltodemonstratetheOTCOprogram’scompetencyandexpertisewhenoffering
certificationservicestovoluntaryorganicstandards,suchastheGlobalOrganicTextile
Standards,NCTP,andtheNSF/ANSI305Standard.
OnApril29,2002,OTCOwasgrantedaccreditationbytheUSDANationalOrganicProgram
(NOP)fororganiccertificationofcrop,livestock,wildcropandhandlingoperations.OTCO’s
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accreditationmeansthatproductionandhandlingoperationscertifiedbyOTCOaredeemed
certifiedinaccordancewiththeNOPprovisions.
OnJuly6,2009,OTCOwasgrantedaccreditationbytheCanadianFoodInspectionAgency
(CFIA)fororganiccertificationofcrop,livestock,wildcropandhandling[processingB3.5.8]
operations.OTCO’saccreditationmeansthatproductionandhandlingoperationscertifiedby
OTCOaredeemedcertifiedinaccordancewiththeCFIAprovisions.
In2016OTCOreceivedrecognitionbySENASICAtooffercertificationtotheMexicoOrganic
Standards(LPO).ThisallowsoperationswithinMexicowithdomesticsaleswithintheircountry
tobecertifiedtothenationallyrecognizedstandard.
OTCOisrecognizedbytheEuropeanCommissionasanapprovedcertificationbodyfororganic
certificationofcropandhandlingoperationsforfoodorfeed.OTCO’saccreditationmeansthat
productionandhandlingoperationscertifiedbyOTCOaredeemedcertifiedinaccordancewith
theEUprovisions.
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G.ENFORCEMENT
TheOTCOProgramhasapositivereputationinthemarketplacebecauseithascreatedand
maintainedahigh-qualitycertificationprogramthatsafeguardsboththefoodproductionand
fooddeliverysystems.However,norulesorlawscanstrengthentheprogrammorethanthe
commitmentoftheoperatorsoftheOTCO-certifiedbusinessestofollowtheproduction
standardswithcareandhonesty.
OTCOinvestigatesallwrittenreportsofviolationofitsstandards.Whentheorganicstandards
areestablishedbygovernmentregulations,theyprovidethelegalstructuresnecessarytocarry
outenforcementactivities.
PARTII:PROCEDURES
A.REQUESTINGACERTIFICATIONPACKET
FirsttimeapplicantsshouldcontacttheOTCOofficetorequestacertificationpacketforthe
typeofcertificationneededfortheirenterprise(s)orvisitthewebsite,www.tilth.orgto
downloadtheapplicablepacket.Thecertificationpacketincludesthefollowingdocuments:
• OTCOProceduresManual(thisdocument)
• OTCOFeeSchedule
• Theapplicableorganicstandard(s)forwhichcomplianceassessmentisbeing
requested
• Theappropriateapplicationform(s)–OrganicSystemPlan(OSP)
• TheOTCOContractandTrademarkUseAgreement
AlloftheabovedocumentsareavailableelectronicallyfromtheOregonTilthwebsite
(www.tilth.org).
B.APPLYINGFORCERTIFICATION
Beginassessingtheeligibilityofyouroperationbyreadingtheapplicableorganicstandard(s),
theproceduresmanual,OrganicSystemPlan(s)(OSP),andcompareyourrecordsandpractices
tothecertificationrequirements.
ThenextstepistofillouttheapplicableOSP(s)completely.Provideasmuchdetailaspossible
andkeepacopyoftheOSPforyourrecords.
Theoperationreceivesthe“OrganicCertificationContractandTrademarkUseAgreement”in
theirinitialcertificationpacket.Thisdocumentsummarizesthetermsandconditionsoforganic
certificationwithOTCO.TheOperatormustsignandreturnthe“OrganicCertificationContract
andTrademarkUseAgreement”totheOTCOofficealongwiththeirapplication.
Acompleteapplicationcontainsthefollowingcomponents:1)thecompleted
application/requestformorOSP;2)asignedContractandTrademarkUseAgreementand3)
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theinitialpaymenttowardscertificationservicesbeingrequested.PleaserefertotheOTCOFee
Scheduleforinformationregardingcertificationfees.
OTCOacceptsallproductionandhandlingapplicationsthatfallwithinthescopeofits
certificationprogramtotheextentofitsadministrativecapacitytodosowithoutregardtosize
ormembershipinanyassociationorgroup,race,color,nationalorigin,gender,religion,age,
disability,politicalbeliefs,sexualorientation,maritalorfamilystatus.
OTCOapplicantsthataredualcertifiedortransferringcertificationservicesfromanother
certificationbodyareobligatedtonotifythecertificationbodyofthesearrangements.
Applicantsmustunderstandbothcertificationbodiesmayexchangetherelevantinformation
ontheoperationsundertheircontrol.ApplicantsmustaddressallNoticesissuedbythe
relevantcertificationbodypriortoOTCOmakingacertificationdecision.Certificationisonly
withtheapplyingcertificationbody,assuchanoperatorcannotuseupexistingsuppliesof
labelswhichidentifytheirpreviousCBonproductstheyproducefromthemomentthe
operatorreceivesthenewcertificate.
ForEU834/2007viaIACBEUEquivalenceStandardapplicants;thepreviouscontrolbodyshall
shareanddeliverrelevantelementsofthecontrolfileoftheoperatorconcernedandthe
reportsreferredtointhesecondsubparagraphofArticle63(2)tothesubsequentcontrolbody.
Thenewcontrolbodymustensurethatnon-conformitiesnotedinthereportoftheprevious
controlauthorityorcontrolbodyhavebeenorarebeingaddressedbytheoperator.Wherethe
operatorwithdrawsfromthecontrolsystem,thecontrolbodyofthatoperatorshall,without
delay,informthecompetentauthority.Whereacontrolbodyfindsirregularitiesor
infringementsaffectingtheorganicstatusofproducts,itshallwithoutdelayinformthe
competentauthorityoftheMemberStatewhichdesignatedorapproveditinaccordancewith
Article27ofRegulation(EC)No834/2007.Thatcompetentauthoritymayrequire,onitsown
initiative,alsoanyotherinformationonirregularitiesorinfringements.Incaseofirregularities
orinfringementsfoundwithregardtoproductsunderthecontrolofothercontrolauthorities
orcontrolbodies,itshallalsoinformthoseauthoritiesorbodieswithoutdelay.
ForCOR&GOTSapplicants,OTCOconfirmsthattheoperationdoesnotandwillnotholdCOR
and/orGOTScertificationwithanotherCertificationBodyatthesametime.Incasesoftransfer,
OTCOhas5businessdaystonotifytheoriginalcertificationbody,andthenthatcertification
bodymustnotifytheoperatorthatthecertificationagreementisterminatedandthatitwillno
longermonitorthecomplianceofitsoperation.Allapplicantsmustunderstandthatthe
certificationbodiesmayexchangetherelevantinformationotheoperationundertheircontrol
andthatallnoticesissuedbytherelevantcertificationbody.
UndertheCanadaOrganicRegime,Inthecasethataproducertransferstheirapplicationfor
certification,itmustbefiled15monthsbeforethedayonwhichtheproductisexpectedtobe
marketedasorganic.Duringthatperiodoftime,compliancetotheCanadaOrganicStandardis
assessedbyOTCO.Theassessmentmustincludeoneinspectionoftheproductionunitduring
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productionintheyearbeforefieldcropsmaybeeligibleforcertificationandoneinspection
duringproductionintheyearfieldcropsareeligibleforcertification.
InitialReviewoftheApplication/OrganicSystemPlan(OSP)
OnceyourOSP,contractandpaymenthavearrivedattheOTCOoffice,wesendyou
acknowledgementofreceipt.Ourstaffwillreviewitforcompletenessandcomplianceorthe
abilitytocomplywiththestandard(s)forwhichyouarerequesting.OTCOstaffwillalsoassess
therequestforcertificationinordertoensurethatOTCOhastheabilitytocertifyyour
operationbasedonyourlocation,thestandard,productorproductiontype.IfOTCOhasno
priorexperiencewiththecertificationschemerequestedwewillcontactyoutodiscuss.
OTCOcommunicatestheinitialfindingsoftheOSPreviewtoapplicantsinareasonableamount
oftime.Thiscorrespondencealsoprovidesacostestimateforcertificationservices.TheOSP
mustbecompletedinfullandreviewedbeforeaninspectioncanbescheduled.Anadditional
feeischargedforanyOSP,whichmustbereturnedforcompletion.
MaterialReview
Producersandhandlersmustprovideacompletelistofsubstancesusedinproductionand
handlingintheirOSP.Thislistincludesfertilizers,soilamendments,pottingsoil,crop
productionaids,andpestcontrolmaterialsusedincropproduction;livestockfeed,feed
supplements,feedadditives,medications,andlivestockproductionaidsusedinlivestock
production;andingredients,processingaids,post-harvesthandlingsubstances,sanitizers,and
facilitypestcontrolmaterialsusedinprocessingandhandling.OTCOwillevaluatethislistto
determinecompliancewithapplicableorganicregulationsandthencommunicateacceptance
ofthematerials.Forbrandedformulatedproductsusedinorganicproduction,OTCOaccepts
thematerialreviewdecisionsofotheragenciesprovidingthisservicesuchastheOrganic
MaterialReviewInstitute(OMRI)andtheWashingtonStateDepartmentofAgriculture(WSDA)
OrganicMaterialReviewProgram.Ifthebrandedformulatedproducthasnotyetbeen
evaluatedbyOTCOoranotherprogram,OTCOwillrequirefullingredientdisclosureofthe
productforevaluation.
C.THEON-SITEINSPECTION
OTCOconductsaninitialon-siteinspectionofeachproductionunit,facility,andsitethat
producesorhandlesorganicproductsandisincludedinanoperationforwhichcertificationis
requested.Anon-siteinspectionisconductedannuallythereafterforeachcertifiedoperation
forthepurposeofdeterminingwhetherthecertificationoftheoperationshouldcontinue.
ForNSF/ANSI305certificationOTCOmaydeterminethataninspectionisnotnecessaryin
ordertodeterminecompliancewiththestandard.Iftheoperationrequestingcertification
underNSF/ANSI305holdsanothervalidOTCOcertificationunderadifferentstandard,OTCO
mayormaynotrequireanadditionalinspectionpriortotheadditionalcertificationtothis
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standard.AllnewoperationsthatdonotholdacurrentOTCOcertificationundergoafull
inspectionpriortobeingcertified.
Allscheduledinspectionsmustbeconductedwhenanauthorizedrepresentativeof
theoperationwhoisknowledgeableabouttheoperationispresentandatatimewhenland,
facilitiesandactivitiesthatdemonstratecomplianceorcapacitytocomplycanbeobserved.If
necessary,theinitialinspectionortheannualon-siteinspectionofoperationscontinuing
certificationmaybedelayedforupto6monthsfromreceiptoftheinitialapplicationtoensure
theinspectionisconductedatsuchatime.
However,whentheintervalbetweentworegularinspectionshasexceededtwelvemonths,
subsequentinspectionswillrestoretheparitybetweenthenumberofcalendaryearsandthe
numberofregularinspections.
Inspectorsmustbegrantedcompleteaccesstotheproductionand/orhandlingoperation,
includingnon-certifiedproductionareas,structures,andalldocumentationandrecords
(includingfinancial)associatedwithorganicandnon-organicproduction.OTCOusesthe
followingprocedureforconductingon-siteinspections:
1) OTCOassignsaninspectorwhosetrainingandexperiencematchestheoperation’s
activities.ForoperationsintheEUcertificationprogram,inspectorsarerotated
every3years.Operationshavetherighttorefusewithinreasontheassignmentof
aninspector.
2) Theinspectorreviewstheoperation’scertificationfile.
3) Theinspectorcontactstheoperationtomakeanappointmentfortheinspectionand
toreviewanypreliminaryquestionsconcerningtheoperation.
4) Theinspectortravelstotheoperationtoconducttheinspectiondocumenting:
a)Theoperation’scomplianceorabilitytocomplywiththestandardsand
applicablerequirements.
b)TheaccuracyofinformationprovidedintheOSPandthepracticesusedorto
beusedbytheoperator.
c)Thatprohibitedsubstanceshavenotbeenandarenotbeingappliedwithin
organicoperations.Collectionandtestingofsoil,water,waste,seeds,plantor
animaltissueandprocessedproductmaybeundertakenatOTCO’sorthe
inspector’sdiscretion.
5) Theinspectortypicallyobservesproductionrecords,productionfields,facilities,
equipment,materialsandpropertyperimeters.
6) Theinspectorconductsanexitinterviewwiththeauthorizedrepresentativeofthe
operationtoconfirmtheaccuracyandcompletenessofobservationsand
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informationgatheredduringtheinspection.Theinspectoralsoaddressestheneed
foranyadditionalinformationaswellasanyissuesofconcern.
On-SiteInspectionsunderCanadianOrganicRegime(COR)
ForoperatorscertifiedundertheCanadianOrganicRegime(COR),theannualsiteinspectionis
determinedbythefollowingparameterstakingintoaccountbothtimingofinspectionand
accesstooperations:
1) Incasesofagriculturaloperations,theinspectionmusttakeplaceduringthe
productionseason.Thisperiodbeginsassoonasalloperationssubjecttoinspection
(seeding,tapping,etc.)beginandendswiththepackagingorplacingincontainers
forstorageofproductstobecertified.Theinspection,includingdocumentreview,
includesnon-organicunitswherethereisreasontosuspectundeclaredsplit
productionofsimilarproducts,andinanysituationrevealinghighriskofcrosscontamination.
2) Whereagriculturalproducerscarryoutsplitproduction,inspectionsmustallow
visualdeterminationofwhatisbeingplantedinallcultivatedfieldswithinthe
productionunit.
3) Theinspectionmustcovertheentireagriculturalproductionsystembeingmanaged
bythefarmoperation,evenifonlypartoftheoperationistargetedbythe
certificationapplication.Theland,premisesandequipmentnotincludedinthe
certificationapplicationmustbeidentifiedandinspected,andmustataminimum
includethefollowing:cropareasorharvestingzones;harveststoragelocations;
preparation,processingandpackagingsites;applicationdatesforphytosanitary
products;andadministrativefollow-up.
Incasesinvolvingprocessingandhandlingoperations,inspectionsmaybecarriedoutanytime
duringtheyear.However,whenbothcertifiableandnon-certifiableproductsaremanufactured
atthesamefacility,theinspectionmustbecarriedoutattimewhentheorganicproductsthat
aretargetedforcertificationarebeingprocessed.IfOTCOdeterminesitisnotpossibleto
conducttheinspectionwhileorganicproductisbeingprocessed,wedocumentthereasonsand
arrangefortheinspectiontobeconductedatatimewhenthefacilitiesandactivitiesthat
demonstratecomplianceorcapacitytocomplycanbeassessed.Theremaynotbemorethan
twoconsecutiveyearswithoutaninspectionwhenorganicproductisbeingprocessed.
ObjectingtotheUseofaParticularInspector
Ifacertificationapplicantorcertifiedoperatorobjectstotheassignmentofaparticular
inspectortoevaluatetheiroperation,theapplicantmaysubmittheirobjectionsinwritingto
theProgramManager.TheProgramManagermayreassigntheinspectiontoanotherinspector.
AdditionalInspections
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OTCOmayconductadditionalinspectionsofnewapplicantsand/orcertifiedoperationsto
determinecompliancewiththestandards.Additionalinspectionsmaybeannouncedor
unannouncedatthediscretionofOTCO.
Additionalinspectionsmayberequiredfornewapplicantstoverifycompliancepriorto
grantingcertification.Thepurposeofanadditionalinspectionistocheckforanychangesinthe
organicproduction/handlingsystemplanoftheoperationsincetheinitialinspectionandto
verifytheoperation’scompliancewiththestandards.
Allcertifiedoperationsaresubjecttounannouncedinspections.Noadditionalfeesareassessed
forunannouncedinspections.
UnannouncedInspections
OTCOdeterminesthenumberofunannouncedinspectionstobecompletedpercertification
standardatthebeginningofeachcalendaryear.
• ForUSDANOPOTCOperformsunannouncedinspectionrepresenting5%ofcertified
clients
• ForCanadianOrganicRegime(COR),OTCOperformsunannouncedinspections
representing3%ofprimaryproducers(cropandlivestockoperations)and5%of
otherclientscertifiedforproductsmadeinCanada.
• FortheGlobalOrganicTextilesStandard(GOTS)OTCOperformsunannounced
inspectionrepresenting5%oftheGOTScertifiedclients.
• ForEU834/2007viaACBEUEquivalenceStandardOTCOperformsunannounced
inspectionrepresenting10%ofthecertifiedclientsbasedonariskassessmentfor
compliancetothisstandard.
• Additionalstandardsareevaluatedforrequirementsofunannouncedinspections
andpercentagesrequiredannually.
OTCOchoosestheoperationstoreceiveunannouncedinspectionsusingthefollowingcriteria:
•
RandomchoicebytheCertificationDirector
•
Soilresiduetestsindicatingalikelihoodofcontaminationthroughuptakeof
pesticideresidues
•
Productionofcropswhichareknowntoconcentratesoilpesticideresidues
•
Operationswithrequirementsforthecorrectionofminornoncompliancesidentified
asconditionsofcontinuingcertification
•
Stafforinspectorrecommendationforunannouncedinspection
• ComplaintreceivedbyOregonTilthregardingoperation’scompliance
TheInspector’sReport
OTCO Procedures Manual rev. 05/30/2017
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Eachinspectionculminatesinaninspectionreport.Thereportsummarizestheoperation’s
OrganicSystemPlanpracticesandevaluatesthemforcompliancewithorganicstandards.Each
reportincludesalistofallpointsofconcernandpotentialnoncompliancefoundbythe
inspector.
DocumentsProvidedtoInspectedOperations
Attheconclusionoftheinspection,theinspectorissuestheinspectedoperationanExit
InterviewFormsummarizingtheInspector’sobservationsandsignedbyboththeinspectorand
theoperator.Acopyofthisformbecomespartoftheinspectionreport.Asapplicable,the
inspectoralsoprovidesacopyofthechainofcustodysheetforanysamplestakenduringthe
courseoftheinspection.Acopyoftheinspectionreportandanytestresultsaresenttothe
inspectedoperationwithinareasonableamountoftime.
UseofContractorsandSubcontractors
OregonTilthmaintainsitsresponsibilityforgranting,maintaining,suspendingorrevoking
certificationofanoperation.OregonTilthmaydecidetooutsourceworkrelatedtocertification
(e.g.testingand/orinspection)toanexternalbodyorperson;inwhichcase,OTCOpromptly
notifiesitsAccreditationBodyandGlobalStandardGmbHaboutthesubcontractedbodyand
thekindofsubcontractedwork.OregonTilthtakesfullresponsibilityforsuchcontractedand
subcontractedwork,includingconfidentiality.ByapplyingforcertificationwithOregonTilth,
applicantsconsenttotheuseofcontractorsandsubcontractorsduringthecertification
process.
D.THEDECISIONMAKINGPROCESS
Uponreceiptofallnecessarydocumentation,aqualifiedanddesignatedOTCOCertification
OfficercreatesasummaryoftheoperationbasedonareviewoftheOrganicSystemPlan
(OSP),inspectionreport,testresultsandanyadditionalapplicableinformation.Thisreview
processdeterminesiftheOrganicSystemPlanandallproceduresandactivitiesoftheorganic
operationareincompliancewiththestandardsandthattheoperatorisabletoconduct
operationsinaccordancewiththeplan.Thesummaryconcludeswithadecisionconcerning
grantingorcontinuingcertificationoftheoperation.Thecertificationdecisionsaremadewithin
reasonableamountoftime.FortheGOTSprogram;thedecisionisrenderedwithinatleast2
monthsoftheinspection.
Thecertificationdecisionmayidentifypointsofnoncomplianceincludingatimeframewithin
whichtheapplicantmustdescribecorrectiveactions.Thedecisionmayrequiretheapplicantto
notifyOTCO,inwriting,ofplansforcorrective/preventiveactionsandthetimeframe(s)within
whichtheseactionsaremadepriortograntingcertification.Iftheproposedcorrectiveactionis
sufficienttoqualifyforcertification,thenthecertificationprocesscontinues.
NoncomplianceswiththeStandards
Inordertoencourageproducersinachievingfullcompliancewithorganicstandards,the
certificationdecisionmaygrantorcontinuecertificationwhentherearenoncompliancesthat
requirecorrectiveactiontobringtheoperationintofullcompliance.Anoperationisgiventhe
opportunitytoresolvenoncompliancesviacorrectiveactiononlyifthenoncompliancesdonot:
OTCO Procedures Manual rev. 05/30/2017
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•
Compromisehealthorsafetyofworkers,
•
Compromisetheorganicintegrityoftheproduct,
•
Resultinexcessivecontaminationofproduct(inexcessof5%ofEPAtolerancelevel,
ortheFDAactionlevel),or
Involveintentionalviolationoforganicstandards.
Whenanoperationhasbeengrantedcertification,thestaffmayincluderemindersinthe
approvalletteridentifyinganyissues,whichmayimpactongoingcompliancewiththe
standards.
E.WITHDRAWALOFTHEAPPLICATION
Anapplicantmaywithdrawhis/herapplicationatanytime.Anapplicantwhowithdrawshis/her
applicationisliableforthecostsofservicesprovideduptothetimeofthewithdrawal.Please
refertotheOTCOFeeSchedulefordetails.
•
ANAPPLICANTTHATVOLUNTARILYWITHDREWHIS/HERAPPLICATIONPRIORTOTHECERTIFICATIONDECISION
ISNOTISSUEDANOTICEOFNONCOMPLIANCEORADENIALOFCERTIFICATION.
F.ACKNOWLEDGMENTOFCERTIFICATION
Theoperationissentacertificateaftercompletionofthedecisionprocess.Thecertificate
identifiesthenameofthecertifiedoperation,theiraddress,thescopeofcertification,the
validityperiodandtheapplicablestandardstowhichcompliancewasevaluated.Allcurrently
certifiedoperations,aswellasthetypeofproductstheyproduce,arelistedontheOregonTilth
website(www.tilth.org).
G.CONTINUATIONOFCERTIFICATION
Tomaintainandcontinuecertification,acertifiedoperationmustannuallypaythecertification
feesandsubmitanychangestotheOrganicSystemPlan.InformationincludedontheOSP
submittedtoOTCOmustinclude:
• Anupdateonanychangesintheoperator’sowners,farm/businessname,principal
responsibleperson,contactperson,andcontactinformationincludingaddressandphone
number.
• Information,supportedbydocumentation,describinganydeviationsfrom,changesor
modificationsto,orotheramendmentsmadetothepreviousyear’sOrganicSystemPlan
(OSP);
• Anyadditionsordeletionstothepreviousyear’sOSPintendedtobeundertakeninthe
comingyear;
• AnupdateonthecorrectionofanynoncompliancespreviouslyidentifiedbyOTCOas
requiringcorrectionforcontinuedcertification;
• OtherinformationasdeemednecessarybyOTCOtodeterminecompliancewithorganic
standards.
OTCO Procedures Manual rev. 05/30/2017
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OnceyourOSPupdateandpaymenthavearrivedattheOTCOoffice,wesendyou
acknowledgementofreceipt.Ourstaffwillreviewitforcompletenessandcompliancethen
assignyourinspection.
H.POSTCERTIFICATIONAPPROVALS
Withoutunduedelay,anoperatormustinformOTCOofanychangesthataffectstheOrganic
SystemPlan,duringcertification,includingchangesofproducts,productformulation,acreage
orfacilitiestobecertifiedorinfringementsidentifiedbytheoperator.
I.PRODUCTADJUSTMENT
Withoutunduedelay,whenacertifiedoperatorbeginsanewventureandwantstoadd
productstothoselistedonthecurrentcertificate,theoperatormustsubmitrelevant
information,withsupportingdocumentationtotheOTCOoffice.OTCOconductsareviewof
theproductadjustmentrequestandsupportingdocumentationtodeterminetheextentofthe
changestothecurrentproductionsystemneededtoproducethenewproduct(i.e.new
fields/facilities,equipment,agricultural/processinginputs).Ifthechangestothesystemare
minimal,consistentwithexistingpracticesdescribedintheOrganicSystemPlanandareclearly
withinorganicstandards,OTCOissuesanamendedcertificatetotheoperator.Ifthechanges
areextensiveorarenotsufficientlydescribed,OTCOmayrequireaninspectionofthenew
productionand/orhandlingsystembeforeaddingtheproducttothecertificate.
J.CORATTESTATIONOFCOMPLIANCE
OTCOwillissue"AttestationofCompliance"toserviceproviderswhoperformcontractualwork
foroperatorswithcertifiedproductandwheretheserviceisnoteligibleforcertificationunder
section14oftheOPR.Anattestationofcompliancewillrecognizetheservicesasbeingin
accordancewithCAN/CGSB32.310and32.311tomaintaintheintegrityoftheorganicproduct
andeliminatetheneedformultipleinspectionsresultingfromverificationforthecertification
ofthefinalproducteverytimeadifferentoperatorcontractstheservices.
AnattestationofcomplianceisawrittendocumentissuedbyOTCOconfirmingthatthe
provisionofaservicethroughaparticularactivitytakingplacewithintheproductionor
manufacturingprocessofacertifiedproductisinfullaccordancewithCAN/CGSB32.310and
32.311asprescribedintheOrganicProductsRegulations,2009.Thismeansthatalthoughthe
serviceproviderdoesnotholdacertification,OTCOhasverifiedthattheproductsubjectedto
thisserviceremainscompliantwiththeCAN/CGSB32.310and32.311.
An"Attestationofcompliance"shallbeapplicableforthefollowingtypesofcustomservices:
• Theservicesidentifiedasbeingexemptforcertificationinsection19oftheOPR,i.e.the
slaughteringoforganiclivestock,orthetransportationandstorageoforganiclivestock
oranorganicproduct".
• Othercustomservicesforbulkproductsuchasseedcleaningwheretheownershipof
theproductremainswiththeprimaryproducer.
OTCO Procedures Manual rev. 05/30/2017
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OTCOwillrequirethattheoperatorcompleteanapplicationformandtheapplicableorganic
systemplandemonstratehowtheintegrityoftheorganicproductismaintained.OTCOwill
thenverifycomplianceasapplicabletotheserviceoffered.OTCOwillconductanannual
inspectionandconductanynoncompliancefollowupasnecessary.OTCOwillthenissuean
"AttestationofCompliance.”OTCOmaysuspendorcancelan"AttestationofCompliance"as
perAdverseActionprocedures.
Any"AttestationofCompliance"issuedbyOTCOorreceivedbyOTCObyanaccreditedCBas
meetingtheOPRrequirementsformaintenanceofintegritywillnotrequireanyfurther
verification.
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PARTIII.PROCEDURESFORCERTIFICATIONOFMULTI-SITEOPERATIONS
A.DESCRIPTIONOFMULTI-SITEOPERATION
Amulti-siteoperationwithdemonstratedinternalcontrolsystem(a.k.a.cooperativeorgrower
group)involvesacentrally-managedassociationoflocalgrowersproducingsimilarcropsusing
similarpracticesandmarketingtheirproductsincommon.Themulti-siteoperationcompletesa
singleapplication,whichdescribes,inadditiontothestandardinformation,detailsoftheir
internalcontrolsystem,andincludesdetailedgrowerlistsandcodenumbersasapplicable.One
certificateisissuedcoveringallindividualmembers.Allsalesofcertifiedproductmustbesold
throughthecertifiedlegalentity;individualgrowerscannotmarketcertifiedproductoutsideof
thegroup.Certificationfeesarebasedonsalesfiguresoftheentireoperationactingasone
entityandreportedintheapplication.PleaserefertotheOTCOFeeScheduleforinformation
oncertificationfees.
B.REQUIREMENTSFORMULTI-SITEOPERATIONS
Groupswishingtoapplyasamulti-siteoperationmusthaveaninternalcontrolsystem(ICS),
whichmeetsallthefollowingcriteria:
• AnInternalControlSystemisdefinedasawrittenqualityassurancesystemincludedin
theOSPthatsetsforththepracticestandards,recordkeeping,decision-making
procedureandaudittrailrequirementsapplicableateachproductionunit,facilityorsite
andthatidentifiestheinternalverificationmethodsused.
• Theinternalreviewerscarryoutatleastoneannualdirectobservationandreviewof
eachindividualoperator,includingvisitstoallfieldsandfacilities.
• TheInternalControlSystemmaintainsappropriatedocumentation,includingat
minimumadescriptionofthesubunitsandthefacilities,theproductionplans,materials
usedandratesofapplication,harvestrecords,thecontractualarrangementwitheach
individualmemberandinternalinspectionreports.
• TheInternalControlSystemmustincludethedecisionmakingproceduresusedand
applicationofsanctionstoindividualmemberswhodonotcomplywiththe
organization’sOSP,theOFPAortheNOPRegulations,and/orotherapplicable
standards.
• InternalcontrolstaffmustinformOregonTilthoftheirregularitiesandminornoncompliancesfoundduringinternalaudits.Theymustcommunicatebacktothe
individualoperatoroftheminornon-compliancethecorrectiveactionsimposed,with
agreedtimeforcompletion.
• TheInternalControlSystemmustprovideforthesuspensionorexclusionofmembers
orsubunitswhoarefoundtohavemajornon-compliances,includingaplanfor
correctiveactionthatmustbeimplementedbeforethememberorsubunitcanbe
readmitted.InternalcontrolstaffmustinformOregonTilthofallsuchactions,anda
memberwhowillfullyorfraudulentlyviolatestheNOP,and/orotherapplicable
standards,shouldnotbepermittedtorejointhegroupuntilOregonTilthapprovesthe
measurestakentoensurethattheviolationisnotrepeated.
OTCO Procedures Manual rev. 05/30/2017
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MinimumCriteriaforInternalControlSystemPersonnel
Aproject'sInternalControlSystemstaffauditorsmustmeetthefollowingcriteria:
• Befluentinthelocallanguageanddialectofthegroupmembers
• Possesstheabilitytoread,writeandreportinthechosenInternalControlSystem(ICS)
language
• Bewell-versedintheNationalOrganicProgram,aswellasotherapplicablestandards,
especiallyinthesectionsoftheregulationthatrelatetothesubunitsandmembers,
sitesorfacilitiesthattheyreview
• Befamiliarwiththelocalagriculturalproductionsystems
• Befamiliarwiththeprinciplesandpracticeoforganicagriculture,asapplicable
• Befamiliarwiththeprinciplesandpracticesoforganichandling,asapplicable
• Beabletodemonstratecompetenceininternalcontrolproceduresandan
understandingoftheinternalregulations
Inordertomitigatethepotentialfornoncompliancestogounreported,theInternalControl
Systempersonnelmustreceivecontractual(in-writing)assurancesthatundernocircumstances
aretheytobeadmonishedinanywaybecausetheyhavedetectedandreporteda
noncompliance.
Multi-Siteoperationsthatcannotadequatelydemonstratecompliancewiththeabovecriteria
tothesatisfactionofOTCOstaffmustapplyasindividualgrowers.
C.INSPECTIONSOFMULTI-SITEOPERATIONS
Thequantityoffarmsitesinspecteddependspredominatelyonthetotalnumberofsiteswithin
thegrowergroup,aswellasotherriskvariablessuchassalesvolumeoforganicproduct,area
certified,numberofyearscertified,andpreviouscomplianceconcerns.Fornewgrowergroups
orgrowergroupsseekingrenewaloftheircertification,OregonTilthcalculatesthenumberof
parcelstoinspectbytakingthesquarerootofthetotalnumberofparcelsrequestedfor
certification,andthenmultipliesbyariskfactor,whichisdeterminedbasedonfactors
describedbelow.ForMulti-SiteoperationstobecertifiedtotheMexicanOrganicProductsLaw,
atleast10%ofthetotalnumberofgrowersareinspected.
Thegrowergroupriskfactorisusedtodeterminethenumberofparcelstoinspectannually.In
allcases,predominantlydifferentgroupmembersareinspectedeachyear.Thisriskfactormay
besignificantlyhigherdependingonproblemsencounteredduringevaluationoftheInternal
ControlSystemorconcernsidentifiedduringtheinspection.Newmembersmustbeinspected
andallnoncompliancessuccessfullyresolvedbeforebeingaddedtothegroup.OTCOconducts
anannualinspectiononeveryprocessor,exporterandlargefarmofthegroup.Alargefarmis
definedasasitewithaproductionareaofmorethan10%ofthetotalproductionareaofthe
group.
OTCO Procedures Manual rev. 05/30/2017
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PARTIV.PROCEDURESRELATEDTOTRANSITIONALCERTIFICATION
OregonTilthispleasedtooffertransitionalcertificationservicesinordertoassistgrowerswith
thetransitionperiod.TransitionalagriculturalproductsfalloutsidethescopeoftheUSDA
NationalOrganicProgram.TransitionalstandardsarebasedupontheOrganicFoodsProduction
Actof1990andtheapplicableproductionandhandlingstandardsestablishedbytheUSDA
NationalOrganicProgramunder7CFRPart205,excepttransitionalproductslackcompliance
with§205.202(b).FollowingaretheapplicablesectionsoftheUSDANationalOrganicProgram
FinalRulethatapplytoClassTcertificationwithOTCO:
SubpartB
Recordkeepingrequirementsandcertainallowedandprohibitedpracticesare
locatedinSubpartB.RecordkeepingrequirementsarealsodescribedinSubpart
E,subsection205.400.
SubpartC
Generalproductionstandardsincludingfarmmanagementplans,soilfertility
andpestmanagementpracticestandards,andseedandplantingstockstandards
arepresentedinsubsections205.200-206.Postharvesthandlingrequirements
aredescribedinsubsections205.270-272.Pleasenotethatthelandrequirement
forTransitionalcertificationis1yearfreeofprohibitedsubstancesinsteadof3
yearsfororganicproduct,asestablishedin205.202(b).
SubpartG
Syntheticsubstanceswhichareallowedforuseintransitionalcropproduction
arelistedinsubsection205.601.Nonsyntheticmaterialswhichareprohibitedfor
useintransitionalcropproductionarelistedinsubsection205.602.Postharvest
materialsaredefinedinsubsection205.605.
Becausetransitionalproductslackcompliancewith§205.202(b),theymustnotbelabeled,sold,
orrepresentedusingtheword“organic”inanyform.
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PARTV.PROCEDURESREGARDINGCONFIDENTIALINFORMATION
AllrecordssenttoOTCOaremaintainedinsecurefiles.Onlyauthorizedaccreditation
authorities,includingstateandfederalofficials,andappropriatecertificationand
administrativestaffhaveaccesstothesefiles.
OTCOrequiresthatpersonnelwhohaveaccesstoconfidentialinformationsigna
“Confidentiality/Non-disclosureAgreement”whichprohibitsthemfromreleasingconfidential
information(exceptasdescribedbelow).Thisappliestoallcertificationandadministrativestaff
aswellasanyotherOregonTilthprogrampersonnel,inspectors,andcommitteemembers
includingtheBoardofDirectors.
Confidentialinformationincludes,butisnotlimitedtodiscoveries,ideas,designs,drawings,
specifications,techniques,models,data,documentationofprograms,processes,know-how,
customerlists,marketingplans,andfinancialandtechnicalinformation.
ReleasingInformation
OTCOmayreleasethefollowinginformationtothepublicwithoutwrittenpermissionfrom
certifiedoperations:
• Certificationcertificatesissuedduringthecurrentandthreeprecedingcalendaryears;
• Alistofcertifiedoperators,includingthenameandaddressofoperations,type(s)of
operations,productsproduced,andthevalidityperiodofcertification,duringthe
currentandthreeprecedingcalendaryears;
• Theresultsoflaboratoryanalysesforresiduesofpesticidesandotherprohibited
materialsconductedduringthecurrentandthreeprecedingcalendaryears.
Listsmaybepublishedbyregulatorybodies(USDANOP,EU),listedontheOTCOwebsiteor
byschemeowners(i.e.GOTS).
Ifmoreinformationisneeded,OTCOusuallyreferstheinquirytothepublishedstandardsand
directlytothecertifiedoperation.OTCOreleasesadditionalinformationonlywiththewritten
permissionofthecertifiedoperation.
OTCOrequiresclientstosigntheContractandLabelUseAgreement,whichgivesOTCOthe
righttoreleaseinformationonindividualoperationsasrequiredbylocal,state,orfederallaw,
toaccreditationauthoritiesandasrequiredwithanothercertificationbodytoexchange
necessaryinformationtodeterminestatusofcompliance.
RequestsforResearchData
ThecertificationstaffmayprovideresearcherswithsummariesorstatisticsbasedonOTCO
files,butmaynotreleaseconfidentialinformationconcerningindividualoperationswithout
explicitpermissiontodosofromthecertifiedoperation.
OTCO Procedures Manual rev. 05/30/2017
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PARTVI.ENFORCEMENTANDADVERSEACTION
Themarketplaceacceptanceandsuccessofthird-partycertificationprogramsstronglydepends
ontheconsumers’confidenceintheauthenticityandintegrityunderlyingcertifiedproduct
labelclaims.Tothisend,OTCOimplementsqualitycertificationservicesthatensurecompliance
priortograntingcertificationandmonitorscontinuedcomplianceofcertifiedoperations.
Afteranapplicantoperationhasbeeninspectedandassessedforcompliancewiththeorganic
standards,itiseitherapprovedforcertificationordeniedduetonon-compliance.Ifitis
approved,theapplicantreceivesacertificate.Certifiedoperationssubmitannualchangesto
theirOrganicSystemPlan,areinspectedannually,andaresubjecttounannouncedinspections.
OTCO’senforcementproceduresoccurinvariouscontextsandincludetheabilitytotake
adverseactionagainstnoncompliantoperationstoprotectconsumerconfidenceintheorganic
certificationprocess.Enforcementproceduresalsoincludemeasurestoensuredueprocess
protectstherightsofcertificationapplicantsandcertifiedoperatorsbyprovidingan
opportunitytorespondtononcompliancefindingspriortoadverseactiontakenbyOTCO.This
combinationofadverseactionanddueprocessensuresthecertificationprocessremainsstrict
butfair.
SupportforenforcingmanyoftheorganicstandardstowhichOTCOofferscertificationservices
areprovidedbyfederaland/orregionalgovernmentsviaregulationspassedbylaw-making
bodies.Theselawsoftenprovidepenalties,includingfines,forviolationsofthestandardsset
forthinregulation,suchasfraudulentmislabelingoforganicproducts.Toassistwithsuccessful
implementationofstandardssupportedbygovernmentregulation,OTCOmaintainsactive
relationshipswithbothfederalandregionalgovernmentbodies.
DenialofCertification
WhenOTCOhasreasontobelieve,basedoninformationspecifiedintheapplicationform
and/ortheinspectionreport,thatanapplicantforcertificationisnotabletocomplyorisnotin
compliancewiththeorganicstandards,OTCOprovidesawrittennotificationofnoncompliance
totheapplicant.Whencorrectionofanoncomplianceisnotpossible,anotificationof
noncomplianceandanotificationofdenialofcertificationmaybecombinedinonenotification.
Inresponsetosuchnotifications,applicantsmay1)requestmediation;2)requestappeal;or3)
re-applyforcertificationwithanycertificationagentuponcorrectionofidentified
noncompliances.
Whenapplicantsreceiveanotificationofdenial,theyareprovidedaclearreferencetothe
applicableregulation/standardwiththeoptionofrequestingmediationorappealingthe
decision.
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NoncomplianceIssuesforCertifiedOperations
Whenaninspection,review,orinvestigationofacertifiedoperationbyOTCOrevealsany
noncompliancewithorganicstandards,awrittennotificationofnoncomplianceissenttothe
certifiedoperation.Thenotificationprovides:
• Adescriptionofeachnoncompliancewithaclearreferencetotheapplicable
regulation/standard
• Thefactsuponwhichthenotificationofnoncomplianceisbased
• Whencorrectionofthenoncomplianceispossible,thedatebywhichthe
certifiedoperationmustrebutorcorrecteachnoncomplianceandsubmit
supportingdocumentationofeachsuchcorrection.
Whenacertifiedoperationdemonstratesthateachnoncompliancehasbeenadequately
addressed,OTCOsendsthecertifiedoperationwrittennotificationthatthenoncomplianceis
resolved.IfapartialorincompleteresponseisreceivedOregonTilthsendstheoperation
correspondencenotifyingthemofpendingconditionsthatrequirearesponse.
Whenrebuttalisunsuccessfulorcorrectionofthenoncomplianceisnotcompletedwithinthe
prescribedtimeperiod,OTCOsendsthecertifiedoperation,andprovidestheappropriate
governmentauthorityifnecessary,awrittennotificationofproposedsuspensionorrevocation
ofcertification.Certifiedoperationsnotifiedofproposedsuspensionorrevocationareprovided
withaclearreferencetotheapplicableregulation/standardandtheoptionofrequesting
mediationorappealingthedecision.
Ifthecertifiedoperationfailstorequestmediation,ortofileanappealoftheproposed
suspensionorrevocationofcertification,thenOTCOsendsthecertifiedoperationawritten
notificationofsuspensionorrevocation.Thenotificationdescribestheeffectofasuspensionor
revocationonfutureeligibilityforcertification.OTCOdoesnotsendanotificationofsuspension
orrevocationtoacertifiedoperationthathasfiledanappealwhilefinalresolutionispending.
RequestsforreinstatementofasuspendedoperationundertheUSDANOParereviewed
accordingtoNOPpolicy.ReinstatementsunderotherOTCOstandardsmaybesubjectto
reviewbyotherauthorities.InallcasesOTCOwillfollowedprescribedpoliciesidentifiedbythe
accreditationorauthorities.Ifreinstatementisgranted,OTCOwillmakeallnecessary
modificationtoformalcertificationdocumentspublicinformation,andauthorizationsforuseof
marktoensurethatthevalidityperiod,revisedscope,andreinstateddateareclearand
transparent.
NoncomplianceundertheCORStandard
OperatorscertifiedtotheCanadaOrganicStandardwhowishtochallengetheinterpretationof
thestandardmaydosoaccordingtotheOperatorManualSectionC.5.IfboththeOperatorand
OTCOagreethatthereisneedforclarificationofstandardslanguagearequesttotheCanada
StandardsInterpretationCommittee(SIC)issubmittedbyOTCO.Anynoncomplianceaffected
bytherequestisplacedonholdpendingresponsefromtheSIC.Certificationwork,including
issuanceofcertificates,proceedsasnormal.
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IncaseswheretheoperatorandOTCOdonotagreethatanissueneedsclarification,OTCO’s
decisionstandswhiletheoperatorrequestsinterpretationorclarificationfromOTCO’s
CertificationVerificationBodyortheSIC.
OTCO’sResponseToAllegationsofViolationsofStandards
OTCOmayreceiveinformationorcomplaintsaboutsuspectedviolationsofstandardsfrom
consumers,inspectors,farmers,distributors,brokers,governmentofficials,oranyother
interestedparty.Detailsaboutthesuspectedproblemmustbesubmittedinwritingbefore
OTCObeginsaformalinvestigation.Followingevaluation,theinformantisprovidedacourtesy
letterconfirmingresolution.Asrequiredunderapplicableorganicregulationsand/orstandards,
OTCOnotifiestheappropriateoversightauthoritiesofallcomplianceproceedingsandactions
takenthatresultfromaformalinvestigation.
MarketplaceLogoMonitoring
OTCOperiodicallysurveysretailarenastomonitoruseoftheOTCOnameandlogointhe
marketplaceandevaluateproductlabelclaimsforconformancewithlabelingprovisions
establishedinapplicableorganicstandardsandprovisionsintheOTCOOrganicCertification
ContractandTrademarkUseAgreement.AnydiscrepanciesarereportedtotheCertification
Directorconcurrentwithanotificationtotheoperator.
ResidueTestingofCertifiedOrganicProducts
Allcertifiedproductsthataresoldlabeledorrepresentedasorganicoranyotherlabeling
categoryunderthestandardsmustbemadeaccessiblebycertifiedorganicproductionand
handlingoperationsforexaminationbyOTCO,oranygoverningofficialwithregulatory
authorityassociatedwiththeapplicableorganicstandards.
OTCO,orothergoverningofficials,mayrequirepre-harvestorpostharvesttestingofany
agriculturalinputusedoragriculturalproducttobesold,labeled,orrepresentedasorganic
basedonrisktocompliancewiththestandard.Wheretheuseofproductsnotauthorizedfor
organicproductionissuspectedtestingisconductedaccordingly.Anappropriatelydesignated
representativemustconductsuchtestsforOTCOorgoverningofficialsattheofficial'sor
OTCO'sownexpense.
ForoperationscertifiedundertheUSDANOPstandards,OTCOisrequiredtoconductsampling
on5%ofthecertifiedoperationsataminimum.OTCOconductsthesamplingandtestingin
accordancewithNOPpolicyforsamplingpesticideresidues.WhileOTCOwilltypicallyconduct
testingonorganicproducts,wemayconductsamplesandtestingonsoil,planttissueorother
asnecessary.
ForCORcertifiedoperatorsOTCOrequiressamplingandtestingaspartoftheinvestigationofa
complaintreceivedaccordingC.1.dintheCanadaOrganicOperationsManual.
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ForEUandCORcertifiedoperatorsOTCOisrequiredtosampleandtestaminimumof5%of
theoperationsannuallybasedonariskanalysis.OTCOmaycollectthe5%aspartofan
investigationofacomplaint,anunannouncedinspection,evaluationofriskduringan
inspectionorastheneedarisestomaintaincompliancewithregulations.
ReportingandInvestigatingResidueTestResults
Iftestresultsindicateaspecificagriculturalproductcontainspesticideresiduesor
environmentalcontaminantsthatexceedtheFDA,EPAorotherregulatorytolerances,OTCO
promptlyreportssuchdatatothefederalhealthagencyorcomparableinternational
authoritieswhoseregulatorytoleranceoractionlevelhasbeenexceeded.
ExclusionfromOrganicSaleUndertheUSDANOP
Whenresiduetestingdetectsprohibitedsubstancesatlevelsabove5percentoftheEPA
tolerancelevel,ortheactualFDAactionlevel,theagriculturalproductmustnotbesold,labeled
orrepresentedasorganicallyproduced.OTCO,thestateorganicprogram’sgoverningstate
official,ortheUSDAmayconductaninvestigationofthecertifiedoperationtodeterminethe
causeoftheprohibitedsubstance’spresence.
PartVII:APPEALSANDMEDIATION
A.PROCEDURESRELATINGTOMEDIATION
Anydisputewithrespecttodenialofcertificationorproposedsuspensionorrevocationmaybe
mediatedattherequestoftheapplicantforcertificationorcertifiedoperation.Therequest
mustbesubmittedinwritingtoOregonTilthorinsomecasesverbalnotificationisallowed.
OTCOmayacceptorrejectrequestsformediation.IfOTCOrejectstherequestformediation,
OTCOprovideswrittennotificationadvisingtheapplicantorcertifiedoperationoftherightto
requestanappeal.IfOTCOacceptstherequestformediation,suchmediationsareconducted
byaqualifiedmediatormutuallyagreeduponbyallpartiestothemediation.Thepartieshave
30daystoreachanagreementfollowingamediationsession.Ifmediationisunsuccessful,the
applicantorcertifiedoperationhave30daysfromterminationofmediationtorequestan
appeal.Anyagreementreachedduringmediationmustbeincompliancewithapplicable
organicstandards.
B.PROCEDURESRELATINGTOAPPEALS
Allappealsarereviewed,heard,anddecidedbypersonsnotinvolvedwiththedecisionbeing
appealed.
AppealsundertheNationalOrganicProgram
UndertheNationalOrganicProgram,appealsofcertificationdecisionstodeny,suspendor
revokemustbemadetothestateorganicprogramor,intheabsenceofastateprogram,
directlytotheUSDA.
PersonswhobelievetheyareadverselyaffectedbyanoncompliancedecisionoftheNational
OrganicProgram’sProgramManagermayappealsuchdecisiontotheAdministratorforthe
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AgriculturalMarketingService(AMS)oftheUSDAwithin30daysfromthereceiptofthe
notification.
AppealstotheStateOrganicProgrammustbefiledinwriting.Allappealsmustincludeacopy
oftheadversedecisionandastatementoftheappellant'sreasonsforbelievingthatthe
decisionwasnotproperormadeinaccordancewithapplicableprogramregulations,policies,
orprocedures.
AppealstotheAdjudicationCommittee
AnyoperationparticipatinginanOregonTilthcertificationprogramoutsidethescopeofthe
NationalOrganicProgrammayrequestthattheAdjudicationCommittee(AC)reconsidera
decisionmadebyOTCOstaff.Theappealmustbemadenolaterthan30daysafterreceiptof
thecertificationdecision.Theappealmustbesubmittedtothecertificationofficebycertified
letterandmustcontain:
• Relevantbackgroundinformationonthecase,
• OTCO’sactionsandrulingsonthecase,
• ReasonstochangeOTCO’sposition,
• Evidencetosupporttheappellant’sassertionsand
• Asuggestedresolutiontotheproblem.
Appellantsarestronglyencouragedtosubmitcompleteinformationwhenmakinganappeal.
Submissionofnewinformationaftertheinitialappealmaydelayschedulingoftheadjudication
meeting.Inordertopreventspuriousappealsandtohelpoffsetthecostofadjudication
proceedings,theappellantmustsubmitafeeof$100withtheappeal.
ProceduresApplicabletotheAdjudicationProcess
TheOTCOadjudicationprocessisdesignedtoprovide
anyoperationparticipatinginanOregonTilth
certificationprogramoutsidethescopeoftheNational
OrganicProgramwiththeopportunitytohavea
certificationdecisionreconsideredwhentheoperator
believesthedecisionwasnotmadeinaccordancewith
theapplicablestandardsand/orprocedures.The
adjudicationprocessencouragesdetaileddiscussionsof
thecaseandendeavorstoreachadecisionthatisboth
equitableandclearlydefensible.Thestepsofthe
adjudicationprocessaresummarizedinthediagram.
Initiating the Adjudication Process
A written appeal and fee is submitted to
the OTCO office.
Notification of Adjudication Meeting
Staff prepares package containing
pertinent documents and provides it
to all parties involved in the case.
Package includes information
concerning date and time of the
meeting.
Adjudication
Committee Meeting
Notification
of decision
OTCO Procedures Manual rev. 05/30/2017
Recording
proceedings
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