final draft phase 1 · 2019-12-21 · u.s. hemp guidance program final draft phase 1 2 lot means a...
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TABLEOFCONTENTSGROWER........................................................................................................................................................1
GeneralTerms&Definitions...............................................................................................................................1
Registration/Application/Notification................................................................................................................3
Registration/ApplicationGuidance.................................................................................................................3
NotificationofChangestothelicensorbythelicensee..................................................................................3
PersonnelGuidance............................................................................................................................................4
PERSONNELGUIDANCECHECKLIST.................................................................................................................5
BESTMANAGEMENTPRACTICESCHECKLIST..................................................................................................6
FACILITY&BIOSECURITYAWARENESSCHECKLIST..........................................................................................7
StorageandDistribution.....................................................................................................................................9
STORAGE&DISTRIBUTIONCHECKLIST.........................................................................................................10
RecordRetention..............................................................................................................................................11
RECORDRETENTIONCHECKLIST...................................................................................................................12
PROCESSOR.................................................................................................................................................13
GeneralTerms&Definitions.............................................................................................................................13
Registration/Application/Notification..............................................................................................................15
Registration/ApplicationGuidance...............................................................................................................15
NotificationofChangestothelicensorbythelicensee................................................................................15
PersonnelGuidance..........................................................................................................................................16
PERSONNELGUIDANCECHECKLIST...............................................................................................................17
PhysicalPlantandGrounds..............................................................................................................................18
PHYSICALPLANTANDGROUNDSCHECKLIST................................................................................................20
FACILITY&BIOSECURITYAWARENESSCHECKLIST........................................................................................21
Equipment........................................................................................................................................................23
EQUIPMENTCHECKLIST................................................................................................................................24
ProductionandProcessControl.......................................................................................................................25
PRODUCTION&PROCESSCONTROLCHECKLIST...........................................................................................26
PackagingandLabelingIndustrialHemp..........................................................................................................27
Guidanceforpackagingandlabelingoperations..........................................................................................27
Qualitycontrolprocedures..........................................................................................................................28
PACKAGINGANDLABELINGCHECKLIST........................................................................................................29
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StorageandDistribution...................................................................................................................................30
STORAGEANDDISTRIBUTIONCHECKLIST.....................................................................................................31
RecordRetention..............................................................................................................................................32
RECORDRETENTIONCHECKLIST...................................................................................................................33
SERVICEPROVIDER......................................................................................................................................34
GeneralTerms&Definitions.............................................................................................................................34
Registration/Application/Notification..............................................................................................................36
Registration/ApplicationGuidance...............................................................................................................36
NotificationofChangestothelicensorbythelicensee................................................................................36
PersonnelGuidance..........................................................................................................................................37
PERSONNELGUIDANCECHECKLIST...............................................................................................................38
PhysicalPlantandGrounds..............................................................................................................................39
FACILITY&BIOSECURITYAWARENESSCHECKLIST........................................................................................41
Equipment........................................................................................................................................................43
EQUIPMENTCHECKLIST................................................................................................................................44
PackagingandLabelingIndustrialHemp..........................................................................................................45
Guidanceforpackagingandlabelingoperations..........................................................................................45
Qualitycontrolprocedures..........................................................................................................................46
PACKAGINGANDLABELINGCHECKLIST........................................................................................................47
StorageandDistribution...................................................................................................................................48
STORAGE&DISTRIBUTIONCHECKLIST.........................................................................................................49
RecordRetention..............................................................................................................................................50
RECORDRETENTIONCHECKLIST...................................................................................................................51
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1 GROWER
1.1 GENERALTERMS&DEFINITIONS ThefollowingDefinitionsandInterpretationsapplytosuchtermswhenusedinthisU.S.HempGuidanceProgram.Adulterationreferstoafoodthatmaybeconsideredadulteratedifitcontains"anypoisonousordeleterioussubstancewhichmayrenderitinjurioustohealth.....orifanyvaluableconstituenthasbeeninwholeorinpartomittedorabstractedtherefrom;or(2)ifanysubstancehasbeensubstitutedwhollyorinparttherefor;or(3)ifdamageorinferiorityhasbeenconcealedinanymanner;or(4)ifanysubstancehasbeenaddedtheretoormixedorpackedtherewithsoastoincreaseitsbulkorweight,orreduceitsqualityorstrength,ormakeitappearbetterorofgreatervaluethanitis".Batchmeansaspecificquantityofindustrialhempthatisuniform,thatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition,andthatisproducedduringaspecifiedperiodoftimeaccordingtoasinglemanufacturingrecord.Batchnumber,orlotnumbermeansanydistinctivegroupofletters,ornumbers,oranycombinationofthem,fromwhichthecompletehistoryoftheprocessing,packaging,labeling,and/orstorageofabatchorlotofindustrialhempproductcanbedetermined.Biomassmeanstheamountoflivingmatterinagivenhabitat,expressedeitherastheweightoforganismsperunitareaorasthevolumeoforganismsperunitvolumeofhabitat.Componentmeansanysubstanceintendedforuseinthemanufactureofindustrialhemp,includingthosethatmaynotappearinthefinishedbatchoftheindustrialhemp.GrowthMediummeansthesolid,liquidorsemi-solidsubstanceusedtosupportthegrowthoftheplant.Hempreferstocannabisvarietiesthatareprimarilygrownasanagriculturalcrop.HempplantsarelowinTHC(marijuana'sprimarypsychoactivechemical).Asestablishedin7U.S.C.§5940,industrialhempmusthaveadelta-9tetrahydrocannabinol(THC)concentrationofnotmorethan0.3percentonadryweightbasis,measuredfromanypartoftheplant.IndustrialHempmeansaplantofthegenusCannabisSativaLandanypartoftheplant,whethergrowingornot,containingadelta-9tetrahydrocannabinol(THC)concentrationofnomorethanthree-tenthsofonepercent(0.3%)onadryweightbasis.Ingredientmeansanysubstancethatisusedinthemanufactureofhempandthatisintendedtobepresentinthefinishedbatchofthehempproduct.In-processmaterialmeansanymaterialthatiscompounded,blended,ground,extracted,sifted,sterilized,derivedbychemicalreaction,orprocessedinanywayforuseinthemanufactureofthehempproduct.
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Lotmeansabatch,oraspecificidentifiedportionofabatch,or,inthecaseofahempproductproducedbycontinuousprocess,aspecificidentifiedamountproducedinaspecifiedunitoftimeorquantityinamannerthatisuniformandthatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition.Microorganismsmeansyeasts,molds,bacteria,viruses,toxins,andothersimilarmicroscopicorganismswhichmayormaynothaveahealthorsanitaryconcern.Pestmeansanyobjectionableinsectorotheranimalincludingbutnotlimitedtobirds,rodents,flies,mites,andlarvae.Physicalplantorfacilitymeansalloranypartofabuildingorfacilityusedfororinconnectionwithmanufacturing,processingpackaging,labeling,orstorageofindustrialhempproductsoringredients.Processormeansmakingatransformativechangetothehempplantorproductfollowingharvest.Productcomplaintmeansanycommunicationthatcontainsanyallegation,written,electronic,ororal,expressingconcern,whichmayormaynothaveberelatedtothequalityofanindustrialhempproduct.Qualitymeansthatthehempproductmeetstheestablishedspecificationsforidentity,purity,strength,andcomposition,andlimitsoncontaminants,andhasbeenmanufactured,packaged,labeled,andheldunderconditionstopreventadulteration.QualityManagementSystemsmeansaplannedandsystematicoperationorprocedureforensuringthequalityofahempproduct.QualityManagementSystemspersonnelmeansanyperson,persons,orgroup,withinoroutsidetheorganization,designatedtoberesponsibleforqualitycontroloperations.Representativesamplemeansasamplewithanadequatenumberofunitsthatareintendedtoensurethatthesampleaccuratelyportraysthematerialbeingsampled.Reservesamplemeansarepresentativesampleofproductthatisheldforadesignatedperiodoftime.Sanitizemeanstoadequatelytreatcleanedequipment,containers,utensils,etc.byaprocessthatiseffectiveindestroyingofmicroorganismsofpublichealthconcerns.
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1.2 REGISTRATION/APPLICATION/NOTIFICATION
Prior to the Industrial Hemp Grower planting any seed, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)
1.2.1 Registration/Application Guidance • Name of the person or corporation to whom the license or authorization is to be issued • Address of the farm or place including county and township or legal description • The number of acres • Global Positioning System coordinates • Intended purpose (seed, oil or fiber) of industrial hemp • In the case of a plant breeder, the variety of industrial hemp that may be cultivated; and
o Any conditions that are necessary to minimize security, public health or safety hazards related to the licensed or authorized activities.
o Specify if the hemp is for food or non-food purposes
1.2.2 Notification of Changes to the licensor by the licensee Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:
• Corporate name or ownership, or officers, and the replacement of an officer, or director • Any change to the address of the licensee • The replacement of an individual referred to a licensee • Any change in the mailing address of the licensee • Any change in the ownership of the land used to cultivate industrial hemp • Any change to the approved cultivar being sown or, in the case of a plant breeder, to the
variety of industrial hemp being sown; • Any genetic modification.
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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1.3 PERSONNELGUIDANCEQualifiedemployeeswhogrow,manufacture,package,orlabelindustrialhempshouldbequalifiedtodoso,andthoseresponsibleforqualitycontrolorperforminganyqualitycontroloperations,musthavetheeducation,training,orexperiencetoperformtheassignedfunctions.Supervisorsshouldbequalifiedbyeducation,training,orexperiencetosupervise.ContaminationPreventionandHygienicmeasuresshouldbetakentoexcludefromanyoperationsanypersonwhomightbeasourceofmicrobialcontamination.Suchmeasurescouldincludethefollowing:
• Excludepersonnelfromworkinginanyoperationsthatmayhaveanillness,infection,openlesion,oranyotherabnormalsourceofcontamination.
• Instructingemployeestonotifytheirsupervisorifthereisapossibilitythattheyhaveahealth
conditiondescribedabove.• Wearingoutergarmentsinamannerthatprotectsagainstthecontamination.• Maintainingadequatepersonalcleanliness.• Washinghandsthoroughly,andsanitizingifnecessary,inahand-washingfacility.
• Removingorcoveringallunsecuredjewelryandotherobjectsthatmightfallinto
components,industrialhemps,equipment,orpackaging.• Usinggloveswhenappropriate.• Wearing,whereappropriate,hairnets,caps,beardcovers,shoes,PPEetc.
Personnelandemployeesafetymeasuresshouldincludethefollowing:
• AppropriateandAdequateFirstAidEquipment
• Adequatebathroomsandchangingrooms
• AppropriateOSHAwarnings,labels,andtraining
• Appropriatetrainingandpersonalprotectiveequipmentforpesticideapplication
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1.3.1 U.S. HEMP GUIDANCE - GROWER - PERSONNEL GUIDANCE CHECKLIST √ if Applicable
YES NO NOTES
Arethesupervisorsqualifiedfortheirresponsibilitiesbytraining,educationorexperience?
Dotheemployeesperformingthegrowing,processing,packagingandlabelingtasks,havethepropertrainingnecessarytoperformthetasks?
Arecontaminationandhygienicmeasuresinplacetoexcludepersonnelwhomightbeasourceofcontamination?
Arepersonnelexcludedfromoperationsiftheyhave,anillness,infection,openlesion,oranyotherabnormalsourceofcontamination?
Doemployeesnotifytheirsupervisorifthereisapossiblehealthconditionasdescribedabove?
Dopersonnelwearoutergarmentsinamannerthatprotectsagainstthecontamination?
Dooperatingpersonnelmaintainadequatepersonalcleanliness?
Arehandwashingfacilitiesavailableandused?
Dooperatingpersonnelremoveorcoverunsecuredjewelryetc.topreventthemfromfallingintohempproductsorcausingharm?
Areglovesusedwhenappropriate?
Arecaps,shoesandheadcoveringusedwhenappropriate?
IstheappropriatePersonalProtectiveEquipment(PPE)usedasneeded?
Arethereadequateandappropriatefirstaidequipmentavailable?
Isthereadequatebathroomsandchangingrooms?
AretheOSHAwarningsandsignsvisible?
Hastherebeenadequatetraining?
IfapplicableisthePPEandtrainsavailableforthepesticideapplicators?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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1.3.2 U.S. HEMP GUIDANCE – GROWER - BEST MANAGEMENT PRACTICES CHECKLIST YES NO NOTES
Areyouusingthebestsoilavailable? HaveyouSoiltestedformacroandmicronutrients? HaveyouusedtheappropriateGrowthMediumforintendedpurposes? HasthelicenseedeterminedtheconcentrationofTHCinthehemp? Isseedplantedlistedonthelicense? Istheentirehempplantusedaslicensed? Doyouproperlyusepre-plantweedcontrol? DoyouhaveaGerminationCertificatefromtheseedsupplier DidyouusetheproperCertifiedSeedsuitableforlocation? Didyouusetheproperseedtreatment? Doyouhaveasitehistory? Doyouhaveawaterqualityreportorhistory? Didyouusefertilizertotargetdesiredyieldperacreaccordingtosoiltest? Didyouuseanimalmanureforfertilizerorbiomasspurposes? Didyouplantbyoptimumseedingdate? Didyouplantattheoptimumrateofseedsperacre? HavesamplesoftheindustrialhempbeencollectedinaccordancewiththeGuidanceProcedures?
Hastheequipmentusedtosow,harvestandtransportthehempbeenthoroughlycleanedtopreventcontamination?
Areyoupreparedtoharvestwhentheplantisready? Haveyoucompliedwiththedryingprocedures Doyouhavesufficientandproperstoragefacilitiesoradequatetransportationequipmentavailable?
IsthebiomasssoldtoalicensedpersonorentityaccordingtheGuidanceProcedures?
Isthebiomasspackaged,labeled,andtransportedaccordingtotheTransportationGuidanceProcedures?
Hasanylossortheftbeenreportedaccordingtothelicenserequirements? AretherecordsbeingkeptaccordingtotheGuidanceProceduresforRecordRetention?
Grower Signature__________________________ Date _________________
Printed Name_____________________________ Farm location or identifier__________________
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1.3.3 U.S. HEMP GUIDANCE - GROWER - FACILITY & BIOSECURITY AWARENESS CHECKLIST A. Facility Security (physical security of buildings and grounds)
√ if Applicable
Is the facility using: YES NO NOTES
Security lighting Perimeter fencing Controlled gate access Off-hours security guard Electronic motion detectors Door alarms Video cameras Adequate indoor lighting Alarms linked to an off-site security system Door hardware is of industrial design Guards are installed on exterior ladders Exit doors and gate are electronically/mechanically secured Entry and discharge points of exterior tanks are padlocked
when not in use
All vehicles parked outside are locked Empty/loaded containers are parked inside Law enforcement patrol over company premises on regular
but unpredictable basis
Employees reporting any suspicious behaviors Restricted access to computer process control and data
systems
Safeguard of data systems using data security program Backup of all data and processes at an off-site place B. Visitor Policy
√ if Applicable
Is the facility using: YES NO NOTES
Company representative for visitor to check in with Signs informing visitors where to report Specific area for visitor parking Records of visitors (include name, company, arrival and
departure, and purpose of visit)
Visitor badges/identification cards Company representative to escort visitor all the time Restricted access to key manufacturing areas C. Distribution
√ if Applicable
Is the facility implementing the following: YES NO NOTES
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Bulk containers are inspected prior to loading for foreign and/or suspicious material
Verify that all customer pick-up drivers are representatives of the customer
The product stream is inspected visually Container access points are secured after loading Seal numbers are documented on the shipping papers Shipping documents are used to identify the contents of each
compartment
Shipping log is maintained Bio-sanitation program is implemented Procedures exist to disinfect vehicles and drivers D. Housekeeping
√ if Applicable
Is the facility implementing the following: YES NO NOTES
Written housekeeping program for all areas of the facility Written pesticide and rodenticide program E. Emergency Response
√ if Applicable
Is the facility implementing the following: YES NO NOTES
Employees are adequately trained to respond to a crisis as calmly and safely as possible
Current inventory of all hazardous and flammable products A plan to provided MSDS to emergency response teams etc. A list of emergency contacts is posted An action plan to deal with suspicious devices or substances Evacuation plan in case of fire and explosions is published Establish and maintain an up-to-date employee roster and
visitor log to facilitate personnel head count at any time
Disaster Preparedness Plan A weapons security program Conduct evacuation and respond drill periodically Post a site plan depicting escape routes, fire-fighting and
rescue equipment
Signature: _____________________________ Date: ________________________________
Printed Name: __________________________ Company: ________________________________
Facility Location: ________________________________
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1.4 STORAGEANDDISTRIBUTIONStorageofindustrialhempshouldbeinunderappropriateconditionsoftemperature,humidity,andlightsothattheidentity,purity,strength,andcompositionofthecomponentsandindustrialhempsarenotaffected.StorageofhempandhempproductsshouldbeproperlylabeledatalltimestopreventcontaminationsandunintendedcominglingStorageofhempandhempproductsshouldbeproperlylabeledtoindicateaholdoravailableforrelease.Storageofmaterialin-processshouldbeidentifiedunderconditionsthatpreventmix-ups,contamination,anddeterioration.Storageofmaterialin-processshouldbeheldunderappropriateconditionsoftemperature,humidity,andlight.Storageofpackagingandlabelsshouldbeunderconditionsadequatetopreventthepackagingandlabelsfrombeingadverselyaffected.Distributionofhempproductsshouldbeunderconditionsthatwillprotecttheproductsagainstcontaminationanddeterioration.
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1.4.1 U.S. HEMP GUIDANCE - GROWER - STORAGE & DISTRIBUTION CHECKLIST √ if Applicable
YES NO NOTES
Istheindustrialhempandhempproductsstoredorwarehousedunderappropriateconditions?
Arethestorageconditionssufficienttopreventadulteration?
Arethestorageconditionssufficienttopreventchangesinspecificationsofthehempproducts?
Isthematerialusedin-processheldunderadequateconditionstopreventchangesinthecomponentsoringredients?
Arethepackagingmaterialsstoredandheldinconditionstopreventdeterioration?
Arethelabelsandlabelingmaterialsstoredandheldinconditionstopreventdeterioration?
Isthehempdistributionplanadequatetopreservethequalityofthehempproducts?
Isthehempdistributionplanadequatetoassurethatthehempproductsareshippedtotheintendedplaceandtotheintendedrecipient?
IstheStorageofhempandhempproductsproperlylabeledatalltimestopreventcontaminationsandunintendedcomingling?
IstheStorageofhempandhempproductsproperlylabeledtoindicateaholdoravailableforrelease?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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1.5 RECORDRETENTIONGrowers/licensee shall keep the records, electronically or hard copy, that contain the following information for at least five (5) years after obtained: • Source of the industrial hemp seed (imported or purchased or grown), name and address and the
country of origin, • Name and (licensee name) license number of the person from whom the seed was purchased, • Form in which the industrial hemp is imported, purchased or sold, • Variety of industrial hemp, • Germination Certificate • Site History including water quality • Statement of appropriate growth mediums • Images of product and labels if available • Curing or drying records • Processing records
• Quantity of each form of industrial hemp imported, purchased, or sold, • Date of planting and harvest,
• Date of each pesticide, herbicide, fungicide and fertilizer application if any, • Destination of the industrial hemp that is sold, - name and address of the purchaser and the
country, to which it is exported, • Date that each shipment of industrial hemp is sent or received,
• Name of the carrier • Results of any tests • Quantity shipped
• Name and (Licensee name) license number of the person to whom the seed was sold.
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Draft 1
1.5.1 U.S. HEMP GUIDANCE – GROWER - RECORD RETENTION CHECKLIST
√ if Applicable
ALLRECORDSARETOBEKEPTFOR5YEARS
DOTHERECORDSINCLUDETHEFOLLOWING? YES NO NOTES Sourceofindustrialhempseedincluding
Name,addressandcountryoforigin
Nameandlicenseofpersonwhosoldtheseed
Formoftheindustrialhempseed
Varietyoftheseed
Quantityoftheseed
Germination Certificate
Site History including water quality
Statement of appropriate growth mediums
Images of product and labels if available
Curing or drying records
Processing records
Dateofplanting
Dateofharvesting
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2 PROCESSOR
2.1 GENERALTERMS&DEFINITIONS ThefollowingDefinitionsandInterpretationsapplytosuchtermswhenusedinthisU.S.HempGuidanceProgram.Adulterationreferstoafoodthatmaybeconsideredadulteratedifitcontains"anypoisonousordeleterioussubstancewhichmayrenderitinjurioustohealth.....orifanyvaluableconstituenthasbeeninwholeorinpartomittedorabstractedtherefrom;or(2)ifanysubstancehasbeensubstitutedwhollyorinparttherefor;or(3)ifdamageorinferiorityhasbeenconcealedinanymanner;or(4)ifanysubstancehasbeenaddedtheretoormixedorpackedtherewithsoastoincreaseitsbulkorweight,orreduceitsqualityorstrength,ormakeitappearbetterorofgreatervaluethanitis".Batchmeansaspecificquantityofindustrialhempthatisuniform,thatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition,andthatisproducedduringaspecifiedperiodoftimeaccordingtoasinglemanufacturingrecord.Batchnumber,orlotnumbermeansanydistinctivegroupofletters,ornumbers,oranycombinationofthem,fromwhichthecompletehistoryoftheprocessing,packaging,labeling,and/orstorageofabatchorlotofindustrialhempproductcanbedetermined.Biomassmeanstheamountoflivingmatterinagivenhabitat,expressedeitherastheweightoforganismsperunitareaorasthevolumeoforganismsperunitvolumeofhabitat.Componentmeansanysubstanceintendedforuseinthemanufactureofindustrialhemp,includingthosethatmaynotappearinthefinishedbatchoftheindustrialhemp.GrowthMediummeansthesolid,liquidorsemi-solidsubstanceusedtosupportthegrowthoftheplant.Hempreferstocannabisvarietiesthatareprimarilygrownasanagriculturalcrop.HempplantsarelowinTHC(marijuana'sprimarypsychoactivechemical).Asestablishedin7U.S.C.§5940,industrialhempmusthaveadelta-9tetrahydrocannabinol(THC)concentrationofnotmorethan0.3percentonadryweightbasis,measuredfromanypartoftheplant.IndustrialHempmeansaplantofthegenusCannabisSativaLandanypartoftheplant,whethergrowingornot,containingadelta-9tetrahydrocannabinol(THC)concentrationofnomorethanthree-tenthsofonepercent(0.3%)onadryweightbasis.Ingredientmeansanysubstancethatisusedinthemanufactureofhempandthatisintendedtobepresentinthefinishedbatchofthehempproduct.In-processmaterialmeansanymaterialthatiscompounded,blended,ground,extracted,sifted,sterilized,derivedbychemicalreaction,orprocessedinanywayforuseinthemanufactureofthehempproduct.
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Lotmeansabatch,oraspecificidentifiedportionofabatch,or,inthecaseofahempproductproducedbycontinuousprocess,aspecificidentifiedamountproducedinaspecifiedunitoftimeorquantityinamannerthatisuniformandthatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition.Microorganismsmeansyeasts,molds,bacteria,viruses,toxins,andothersimilarmicroscopicorganismswhichmayormaynothaveahealthorsanitaryconcern.Pestmeansanyobjectionableinsectorotheranimalincludingbutnotlimitedtobirds,rodents,flies,mites,andlarvae.Physicalplantorfacilitymeansalloranypartofabuildingorfacilityusedfororinconnectionwithmanufacturing,processingpackaging,labeling,orstorageofindustrialhempproductsoringredients.Processormeansmakingatransformativechangetothehempplantorproductfollowingharvest.Productcomplaintmeansanycommunicationthatcontainsanyallegation,written,electronic,ororal,expressingconcern,whichmayormaynothaveberelatedtothequalityofanindustrialhempproduct.Qualitymeansthatthehempproductmeetstheestablishedspecificationsforidentity,purity,strength,andcomposition,andlimitsoncontaminants,andhasbeenmanufactured,packaged,labeled,andheldunderconditionstopreventadulteration.QualityManagementSystemsmeansaplannedandsystematicoperationorprocedureforensuringthequalityofahempproduct.QualityManagementSystemspersonnelmeansanyperson,persons,orgroup,withinoroutsidetheorganization,designatedtoberesponsibleforqualitycontroloperations.Representativesamplemeansasamplewithanadequatenumberofunitsthatareintendedtoensurethatthesampleaccuratelyportraysthematerialbeingsampled.Reservesamplemeansarepresentativesampleofproductthatisheldforadesignatedperiodoftime.Sanitizemeanstoadequatelytreatcleanedequipment,containers,utensils,etc.byaprocessthatiseffectiveindestroyingofmicroorganismsofpublichealthconcerns.
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2.2 REGISTRATION/APPLICATION/NOTIFICATION
Prior to the Industrial Hemp Processor processing any seed or hemp product, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)
2.2.1 Registration/Application Guidance • Applicant’s contact information, including a copy of current driver’s license for applicant and
each proposed signing authority. • Full names of each individual who will be primarily responsible for the processing or handling
the applicant’s hemp material. • Research plan, including the estimated quantity of hemp material to be processed annually. • Address of each location and GPS coordinates of each building or site where hemp will be
stored, processed or handled. • Map(s) depicting each site where hemp will be processed, or stored, and designating
entrances and specific points where GPS coordinates were taken. • Seed/propagule acquisition plan, including a list of proposed affiliated growers. • Material acquisition plan, including a list of proposed affiliated growers. • Marketing plan, including the type of products to be marketed and to whom • Consent to all statements in the Acknowledgments Section in the Processor/Handler
Application. • Quality Management Systems
2.2.2 Notification of Changes to the licensor by the licensee Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:
• Corporate name or ownership or officers & and the replacement of an officer, or director • Any change to the address to the licensee • The replacement of an individual referred to on licensee • Any change in the mailing address of the licensee • Any change in the ownership of the land used to cultivate industrial hemp • Any change to the approved cultivar being sown or, in the case of a plant breeder to the
variety of industrial hemp being sown; Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2.3 PERSONNELGUIDANCEQualifiedemployeeswhomanufacture,package,orlabelindustrialhempshouldbequalifiedtodosoandthoseresponsibleforqualitycontrolorperforminganyqualitycontroloperations,musthavetheeducation,training,orexperiencetoperformtheassignedfunctions.Supervisorsshouldbequalifiedbyeducation,training,orexperiencetosupervise.ContaminationPreventionandHygienicmeasuresshouldbetakentoexcludefromanyoperationsanypersonwhomightbeasourceofmicrobialcontamination.Suchmeasurescouldincludethefollowing:
• Excludingpersonnelfromworkinginanyoperationsthatmayhave,anillness,infection,openlesion,oranyotherabnormalsourceofcontamination.
• Instructingemployeestonotifytheirsupervisorifthereisapossibilitythattheyhaveahealth
conditiondescribedabove.• Wearingoutergarmentsinamannerthatprotectsagainstthecontamination.• Maintainingadequatepersonalcleanliness.• Washinghandsthoroughly,andsanitizingifnecessary,inahand-washingfacility.
• Removingorcoveringallunsecuredjewelryandotherobjectsthatmightfallinto
components,industrialhemps,equipment,orpackaging,• Usinggloveswhenappropriate.• Wearing,whereappropriate,hairnets,caps,beardcovers,shoes,PPE,etc.
Personnelandemployeesafetymeasuresshouldincludethefollowing:
• AppropriateandAdequateFirstAidEquipment
• Adequatebathroomsandchangingrooms
• AppropriateOSHAwarnings,labels,andtraining• Appropriatetrainingandpersonalprotectiveequipmentforpesticideapplication.
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2.3.1 U.S. HEMP GUIDANCE - PROCESSOR- PERSONNEL GUIDANCE CHECKLIST √ if Applicable
YES NO NOTES
Arethesupervisorsqualifiedfortheirresponsibilitiesbytraining,educationorexperience?
Dotheemployeesperformingthegrowing,processing,packagingandlabelingtasks,havethepropertrainingnecessarytoperformthetasks?
Arecontaminationandhygienicmeasuresinplacetoexcludepersonnelwhomightbeasourceofcontamination?
Arepersonnelexcludedfromoperationsiftheyhave,anillness,infection,openlesion,oranyotherabnormalsourceofcontamination?
Doemployeesnotifytheirsupervisorifthereisapossiblehealthconditionasdescribedabove?
Dopersonnelwearoutergarmentsinamannerthatprotectsagainstthecontamination?
Dooperatingpersonnelmaintainadequatepersonalcleanliness?
Arehandwashingfacilitiesavailableandused?
Dooperatingpersonnelremoveorcoverunsecuredjewelryetc.topreventthemfromfallingintohempproductsorcausingharm?
Areglovesusedwhenappropriate?
Arecaps,shoesandheadcoveringusedwhenappropriate?
IstheappropriatePersonalProtectiveEquipment(PPE)usedasneeded?
Arethereadequateandappropriatefirstaidequipmentavailable?
Isthereadequatebathroomsandchangingrooms?
AretheOSHAwarningsandsignsvisible?
Hastherebeenadequatetraining?
IfapplicableisthePPEandtrainsavailableforthepesticideapplicators?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2.4 PHYSICALPLANTANDGROUNDSFacilitiesusedintheprocessing,packaging,labeling,orholdingofindustrialhempshouldbeadequateinsize,construction,anddesign.Facilitiesshouldbesuchtoprovideadequatespacefortheequipmentandmaterialsnecessaryfornormaloperationsaswellasmaintenance,cleaning,andsanitizingoperationsandtopreventcontamination.Equipmentthatcontrolstemperatureandhumidityaswellasfansandotherair-blowingequipmentusedshouldbeadequateforuse.Aislesorworkingspacesbetweenequipmentandwallsshouldbeadequatetopermitallpersonstoperformtheirduties.Adequatelightshouldbeavailableinallareasasneeded.Facilitiesshouldbemaintainedtoprotectagainstcontaminationofindustrialhemp.Facilitymaintenanceshouldincludefacilitiesinrepairsufficienttopreventindustrialhemps,orproductscontamination.Facilityshouldhaveadequatebathroomsandchangingrooms.Facilityshouldhaveasanitary/cleaningplanCleaningcompounds,sanitizingagents,pesticides,andothertoxicmaterialsneedtobefreefrommicroorganismsandthataresafeandadequateundertheconditionsofuse. PestcontrolincludesnotallowinganimalsorpestsinanyareaofyourfacilitiesexceptGuardorworkingdogs.Insecticides,fumigants,fungicides,herbicides,orrodenticides,shouldbeusedwithcareandintheintendedmanner.Watersupplyneedstobesafeandsanitary,atsuitabletemperatures,andunderpressureasneededforappropriateuse.Plumbinginthefacilityshouldbeofanadequatesizeanddesignandbeadequatelyinstalledandmaintainedtosatisfyoperationalneeds.
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Floordrainageshouldbeadequateforoperationsandtopreventcontaminationofindustrialhempproductsorcomponents.Sewagedisposalshouldbeadequateforoperationalneedsandbathrooms.Hand-washingfacilitiesshouldbeavailableanddesignedtoensurethatanemployee'shandsarenotasourceofcontaminationofhempproducts.Trashdisposalshouldbeadequatetominimizeodors,attractpestsorbecomeasourceofcontamination.Groundsshouldbemaintainedtoprotectagainstcontaminationofindustrialhemp.Groundmaintenanceincludes:
• Properlystoringequipment,removinglitterandwaste,andcuttingweedsorgrasssothatitdoesnotattractpests,harborpests,orprovidepestsaplaceforbreeding;
• Maintainingroads,yards,andparkinglotstopreventcontaminationofindustrialhemp
products
• Adequatelyoperatingwastetreatmentanddisposal.
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2.4.1 U.S. HEMP GUIDANCE - PROCESSOR - PHYSICAL PLANT AND GROUNDS CHECKLIST √ if Applicable
YES NO NOTES
Arethefacilitiesusedintheprocessing,packaging,labeling,orstorageofindustrialhempadequateinsize,construction,anddesign?
Dothefacilitiesprovideadequatespacefortheequipmentandmaterialsnecessaryfornormaloperations?
Arethefacilitiesadequateformaintenance,cleaning,andsanitizingandtopreventcontamination?
Doestheequipmentadequatelycontroltemperatureandhumidity? Arethefans/air-blowingequipmentadequateforuse?
Dotheaislesorworkingspacesbetweenequipmentandwallspermitallpersonstoperformtheirduties?
Isthereadequatelightinallareasasneeded?
Arethefacilitiesmaintainedtoprotectagainstcontaminationofindustrialhemp?
Arethecleaningcompounds,sanitizingagents,pesticides,andothermaterialsfreefrommicroorganismsandadequateundertheconditionsofuse?
IspestcontrolsufficienttoexcludeallanimalsorpestsinanyareasexceptGuardorworkingdogs?
Areinsecticides,fumigants,fungicides,herbicides,orrodenticides,usedwithcareandintheintendedmanner?
Isthewatersupplysafeandsanitary,andatsuitabletemperatures,andpressureasneeded?
Istheplumbingofadequatesizeandinstalledandmaintainedtosatisfyoperationalneeds?
Doesthefloordrainagepreventcontaminationofindustrialhempproductsorcomponents?
Isthesewagedisposaladequateforoperationalneedsandbathrooms? Arehand-washingfacilitiesavailabletoensurethatemployee'shandsare
notasourceofcontamination?
Isthetrashdisposalsufficienttominimizeodors,andnotattractpestsorbecomeasourceofcontamination?
Arethegroundsmaintainedtoprotectagainstcontaminationofindustrialhemp?
Istheequipmentstoredandlitterandwasteremovedtopreventpests? Isthegrassmowedandweedscuttopreventpestsaplaceforbreeding? Aretheroads,yards,andparkinglotsmaintainedtoprevent
contaminationofindustrialhempproducts?
Isthewastetreatmentanddisposaloperatingadequately?
DoestheFacilityhaveadequatebathroomsandchangingrooms?
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2.4.2 U.S. HEMP GUIDANCE - PROCESSOR - FACILITY & BIOSECURITY AWARENESS CHECKLIST A. Facility Security (physical security of buildings and grounds)
√ if Applicable
Is the facility using: YES NO NOTES
Security lighting Perimeter fencing Controlled gate access Off-hours security guard Electronic motion detectors Door alarms Video cameras Adequate indoor lighting Alarms linked to an off-site security system Door hardware is of industrial design Guards are installed on exterior ladders Exit doors and gate are electronically/mechanically secured Entry and discharge points of exterior tanks are padlocked
when not in use
All vehicles parked outside are locked Empty/loaded containers are parked inside Law enforcement patrol over company premises on regular
but unpredictable basis
Employees reporting any suspicious behaviors Restricted access to computer process control and data
systems
Safeguard of data systems using data security program Backup of all data and processes at an off-site place B. Visitor Policy
√ if Applicable
Is the facility using: YES NO NOTES
Company representative for visitor to check in with Signs informing visitors where to report Specific area for visitor parking Records of visitors (include name, company, arrival and
departure, and purpose of visit)
Visitor badges/identification cards Company representative to escort visitor all the time Restricted access to key manufacturing areas C. Distribution
√ if Applicable
Is the facility implementing the following: YES NO NOTES
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Bulk containers are inspected prior to loading for foreign and/or suspicious material
Verify that all customer pick-up drivers are representatives of the customer
The product stream is inspected visually Container access points are secured after loading Seal numbers are documented on the shipping papers Shipping documents are used to identify the contents of each
compartment
Shipping log is maintained Bio-sanitation program is implemented Procedures exist to disinfect vehicles and drivers D. Housekeeping
√ if Applicable
Is the facility implementing the following: YES NO NOTES
Written housekeeping program for all areas of the facility Written pesticide and rodenticide program E. Emergency Response
√ if Applicable
Is the facility implementing the following: YES NO NOTES
Employees are adequately trained to respond to a crisis as calmly and safely as possible
Current inventory of all hazardous and flammable products A plan to provided MSDS to emergency response teams etc. A list of emergency contacts is posted An action plan to deal with suspicious devices or substances Evacuation plan in case of fire and explosions is published Establish and maintain an up-to-date employee roster and
visitor log to facilitate personnel head count at any time
Disaster Preparedness Plan A weapons security program Conduct evacuation and respond drill periodically Post a site plan depicting escape routes, fire-fighting and
rescue equipment
Signature: _____________________________ Date: ________________________________
Printed Name: __________________________ Company: ________________________________
Facility Location: ________________________________
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2.5 EQUIPMENTEquipmentandmulti-useutensilsshouldbedesigned,andbuilt,tobesuitableforitsintendeduseandabletobeadequatelycleanedandproperlymaintained.Equipmentshouldbedesignedandbuildsothatusewillnotresultinthecontaminations.EquipmentshouldbeInstalledandmaintainedtofacilitatecleaningtheequipment,utensils,andalladjacentspaces.Equipmentshouldbemaintainedtoprotectindustrialhempfromcontaminations.EquipmentshouldhaveacertificateofInstallationQualification(IQ),OperationalQualification(OQ)andPerformanceQualification(PQ)Freezer,refrigerator,andothercoldstorageequipmentshouldhaveaworkingthermometer.Compressedairorothergasesshouldbeusedandbetreatedinsuchawaythattheindustrialhemp,orcontactsurfaceisnotcontaminated.Instrumentsandcontrolsusedinprocessing,packagingorlabelingortestingindustrialhempproductsshouldbecalibratedasnecessarytoassureaccuracy.Automated,orelectronicequipmentusedtomanufacture,package,label,orholdindustrialhemp,shouldbedesignedtoensurethatindustrialhempproductspecificationsareconsistentlymet.Equipmentshouldbeproperlycalibratedaccordingtothemanufacturesspecifications.Automated,mechanical,andelectronicequipment(includingsoftwareforacomputercontrolledprocess)shouldbeusedandoperatedbytrainedpersonalforproperuse.Utensilsintendedforone-timeuse,(papercups,andpapertowelsetc.)shouldbestoredinappropriatecontainers;anddisposedoftopreventcontamination.Cleaningmaterialsshouldbeapprovedandproperlylabeledforintendeduseandsafeundertheirconditionsofused.
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2.5.1 U.S. HEMP GUIDANCE - PROCESSOR – EQUIPMENT CHECKLIST √ if Applicable
YES NO NOTES
Istheequipmentandmulti-useutensilsdesigned,andbuiltforitsintendeduse?
Istheequipmentabletobeadequatelycleanedandproperlymaintained?
Istheequipmentdesignedandbuildsothatusewillnotresultinthecontaminations?
IstheequipmentInstalledandmaintainedtofacilitatecleaning?
Istheequipmentmaintainedtoprotectindustrialhempfromcontaminations?
DoestheEquipmenthaveacertificateofInstallationQualification(IQ),OperationalQualification(OQ)andPerformanceQualification(PQ)?
Doesthefreezer,refrigerator,andallcoldstorageequipmenthaveaworkingthermometer?
Isthecompressedairorothergasesusedinsuchawaythatthehemp,orcontactsurfaceisnotcontaminated?
Aretheinstrumentsandcontrolsusedinprocessing,packagingorlabelingfortestinghempproductscalibratedtoassureaccuracy?
Aretheautomated,orelectronicequipmentusedtomanufacture,package,label,orholdindustrialhemp,designedtoensurethathempproductspecificationsareconsistentlymet?
Aretheautomated,mechanical,andelectronicequipment(includingsoftwareforacomputercontrolledprocess)usedandoperatedbytrainedpersonalforproperuse?
Aretheutensilsintendedforone-timeuse,(papercups,andpapertowelsetc.)storedinappropriatecontainers;anddisposedoftopreventcontamination?
Arethecleaningmaterialsapprovedandproperlylabeledandstoredandusedundertheirconditionsofused?
IstheEquipmentproperlycalibratedaccordingtothemanufacturesspecifications?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2.6 PRODUCTIONANDPROCESSCONTROLProductionandin-processcontrolsystemshouldbedesignedtoensurethattheindustrialhempismanufactured,packaged,labeled,andheldinamannerthatwillensurethequalityoftheindustrialhempandthattheindustrialhempispackagedandlabeledasspecifiedinthemanufacturingrecord..Specificationsshouldbemadeforanypartofinthemanufacturingprocesswherecontrolisnecessaryandlimitsaresettoensurethequalityandconsistencyoftheindustrialhempproducts.In-processproductionshouldhaveestablishedin-processspecificationsforanypartinthemanufacturingrecordwherecontrolisnecessarytohelpensurethatspecificationsaremetfortheidentity,purity,strength,andcompositionofthehempproductsand,asnecessary,forlimitsonthosetypesofcontaminationthatmayadulterateormayleadtoadulterationofthefinishedbatchofthehempproduct.Productiondocumentationshouldbemadeformeetingthein-processspecifications.Qualitycontrolpersonnelshouldreviewandapprovethein-processdocumentation.ProductDefinitionsandSpecificationsshouldbeestablishedforallindustrialhempproductsforidentity,purity,strength,andcompositionofthehempproduct.Productspecificationsshouldalsoincludethepackagingandlabelingrequirementofthefinishedpackagedandlabeledhemps,LabelingOperationsProceduresshouldbemadeforpackagingindustrialhempproducts.QualityManagementSystemsinthemanufacturing,packaging,labeling,andholdingofindustrialhempshouldensurethequalityoftheindustrialhempispackagedandlabeledasspecifiedinthemanufacturingrecord. QualityControlproceduresshouldinclude:
• Verifytheidentityofanycomponentthatistobeusedintheproductionorprocessingofthehempproducts.
• Maintaindocumentationofverification.
• Monitoreachin-processpartsoftheprocesswherecontrolisnecessarytoensurethequalityofthehempproducts.
• Foreachbatchorlotoffinishedindustrialhempproductsasampleshouldbetakentoverify,ifnecessary,thatthebatchmeetsitsproductspecifications.
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2.6.1 U.S. HEMP GUIDANCE - PROCESSOR - PRODUCTION & PROCESS CONTROL CHECKLIST √ if Applicable
YES NO NOTES
Isthereaprocesscontrolplan?
Istheprocesscontrolsystemdesignedandoperatingforintendeduseofprocessinghemp?
Aretherewrittendefinitionsandspecificationsforprocessinghemp?
Doyouhavespecificationsforpackaging?
Doyouhavespecificationsforlabeling?
Doyouhavequalitymanagementpersonal?
Doesthequalitymanagementpersonalreviewandapprovethein-processdocumentationforallhempprocessing?
Doesthein-processproductioncontrolensurethatonlyspecifiedcomponentsandingredientsareused?
Doesthein-processproductioncontrolensurethatthespecifiedcomponentsandingredientsarelimitedtospecificationsonly?
Iseachlotorbatchgivenaseparateidentityasalotorbatchnumber?
Canthelotorbatchnumberbetracedtoprocessingormanufacturingrecord?
Isthereasampletakenforeachlotorbatchofhempprocessed?
Isthesampleretained?
Isthereaprocessingormanufacturingrecord?
ArethereLabelingOperationsproceduresforpackagingindustrialhempproducts
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2.7 PACKAGINGANDLABELINGINDUSTRIALHEMPPackagingandLabelingproductsreceived,butnotprocessed,shouldhaveacontrolsystemtoexamineeachcontainertodeterminethattheappropriateproductwasreceived,contentlabeled,andthatthecontainerhadnodamage,contaminationordeteriorationofthecomponents.2.7.1 Guidance for packaging and labeling operations Packagingandlabelingoperationsshouldbesuchthattheconditionofthepackagingwillensurethequalityoftheindustrialhempproducts.Issuanceanduseofpackagingandlabelsshouldbecontrolledandrecorded.Packagingandlabelsforeachlotorbatchofindustrialhempshouldbedocumentedtodeterminewhetherthepackagingandlabelsconformtothemanufacturingrecord.Packagedandlabeledindustrialhempshouldbedocumentedthroughdistribution.Packaging,labeling,andotherrelatedoperationsshouldensurethatthequalityoftheindustrialhempproductsarepackagedandlabeledasspecifiedinthemanufacturingrecord,includingthefollowing:• Cleaningandsanitizingallfillingandpackagingequipment,asappropriate.• Protectingindustrialhempsfromcontamination,includingairbornecontamination.• Usingsanitaryhandlingprocedures.• Establishingphysicalorspatialseparationofpackagingandlabeloperationsfromoperationson
othercomponents.• Identifyingcontainersthataresetasideandheldinunlabeledcondition.
• Assigningabatch,lotnumbertoeachlotofpackagedandlabeledindustrialhempfromafinished
batchofindustrialhemp.Representativesamplesofeachbatchofthepackagedandlabeledindustrialhempshouldbekepttodeterminewhethertheproductmeetsspecifications.Suitablydisposingoflabelsandpackagingwhichareobsoleteorincorrecttoensurethattheyarenotusedinanyfuturepackagingandlabeloperations.
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Recordsshouldbekeptofthewrittenproceduresforpackagingandlabelingoperations.Managementshouldapprovethehempproductsforfinaldistribution/sale.2.7.2 Quality control procedures should include: Determinewhetherthereceivedproductmeetstheproductspecification.Approvalofthecomponentsforuseinthepackagingandlabelingofanindustrialhempproduct.Identifyingeachuniquelotwithineachshipmentofcomponentsreceivedsothatitcanbetrackedthroughthepackaging,labeling,marketinganddistributionprocesses.Storageofthecomponentsshouldbeunderconditionsthatwillprotectagainstcontaminationanddeterioration.Collectionofarepresentativesampleofeachlot.Holdpackagingmaterialandlabelsunderconditionsthatwillprotectagainstcontaminationanddeterioration.
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2.7.3 U.S. HEMP GUIDANCE - PROCESSOR - PACKAGING AND LABELING CHECKLIST √ if Applicable
YES NO NOTES
Isthereapackagingandlabelingplantoexamineallincomingcomponentsandingredients?
Doesthepackagingandlabelingplandeterminethattheproductreceivedmeetstheappropriateproductdescription?
Doesthepackagingandlabelingplandeterminethecontainerdamageorcontamination?
Dothepackagingandlabelingoperationsensurethequalityoftheindustrialhempproducts?
Aretheissuanceanduseofpackagingandlabelstotheproperpersonalcontrolledandrecorded?
Arethepackagingandlabelsforeachlotorbatchofhempdocumentedtothatthepackagingandlabelsconformtothemanufacturingrecord?
Arethepackagedandlabeledhempproductsdocumentedthroughdistribution? Arethepackagingandlabelingequipmentcleanedandsanitizedasappropriate? Doesthepackagingandlabelingequipmentprotecthempagainstall
contamination?
Aresanitaryhandlingproceduresbeingused? Istherephysicalorspatialseparationofpackagingandlabeloperations
implemented?
Areallcontainersidentifiedthataresetasideandheldinunlabeledconditionforfutureuse?
Isalotorbatchnumberoneachpackageofhemp? Isarepresentativesampleofeachbatchofthepackagedandlabeledhemp
productkepttodeterminewhethertheproductmeetsspecifications?
Isobsoleteorincorrectmaterialproperlydisposedoftopreventfutureuse? Arerecordskeptofthewrittenproceduresforpackagingandlabelingoperations? Doqualitycontrolproceduresdeterminewhetherthereceivedproductmeetsthe
productspecification?
Isthereanapprovalprocessforthecomponentsforuseinthepackagingandlabelingofhempproduct?
DothequalitycontrolproceduresIdentifyeachuniquelotwithineachshipmentofcomponentsreceivedsothatitcanbetrackedthroughthepackaging,labeling,marketinganddistributionprocesses?
Storageofthecomponentsshouldbeunderconditionsthatwillprotectagainstcontaminationanddeterioration?
Istherearepresentativesampleofeachlot? Arethepackagingmaterialsandlabelsheldunderconditionsthatwillprotect
againstcontaminationanddeterioration?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2.8 STORAGEANDDISTRIBUTIONStorageofindustrialhempshouldbeinunderappropriateconditionsoftemperature,humidity,andlightsothattheidentity,purity,strength,andcompositionofthecomponentsandindustrialhempsarenotaffected.StorageofhempandhempproductsshouldbeproperlylabeledatalltimestopreventcontaminationsandunintendedcominglingStorageofhempandhempproductsshouldbeproperlylabeledtoindicateaholdoravailableforrelease.Storageofmaterialin-processshouldbeidentifiedunderconditionsthatpreventmix-ups,contamination,anddeterioration.Storageofmaterialin-processshouldbeheldunderappropriateconditionsoftemperature,humidity,andlight.Storageofpackagingandlabelsshouldbeunderconditionsadequatetopreventthepackagingandlabelsfrombeingadverselyaffected.Distributionofhempproductsshouldbeunderconditionsthatwillprotecttheproductsagainstcontaminationanddeterioration.
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2.8.1 U.S. HEMP GUIDANCE - PROCESSOR - STORAGE AND DISTRIBUTION CHECKLIST √ if Applicable
YES NO NOTES
Istheindustrialhempandhempproductsstoredorwarehousedunderappropriateconditions?
Arethestorageconditionssufficienttopreventadulteration?
Arethestorageconditionssufficienttopreventchangesinspecificationsofthehempproducts?
Isthematerialusedin-processheldunderadequateconditionstopreventchangesinthecomponentsoringredients?
Arethepackagingmaterialsstoredandheldinconditionstopreventdeterioration?
Arethelabelsandlabelingmaterialsstoredandheldinconditionstopreventdeterioration?
Isthehempdistributionplanadequatetopreservethequalityofthehempproducts?
Isthehempdistributionplanadequatetoassurethatthehempproductsareshippedtotheintendedplaceandtotheintendedrecipient?
IstheStorageofhempandhempproductsproperlylabeledatalltimestopreventcontaminationsandunintendedcomingling?
IstheStorageofhempandhempproductsproperlylabeledtoindicateaholdoravailableforrelease?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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2.9 RECORDRETENTIONProcessor, packagers and labelers should keep records, electronically or hard copy that contain the following information for at least five (5) years after process or operations • Source of the industrial hemp seed (imported or purchased or grown), name and address and the
country of origin. • Form in which the industrial hemp is imported or processed. • Quantity of each form of industrial hemp imported, purchased or sold. • Destination of the industrial hemp that is sold, name and address of the purchaser and the
country, to which it is exported. • Date that each shipment of industrial hemp is sent or received.
• Name of the carrier, • Results of any tests, • Quantity shipped,
• Written procedures of production processes. • If available all images of products and labels • Processing records including the time the operations were performed. the components,
packaging, labels, or products used and the batch or lot number for the finished product. • Any and all certification documents • Records kept should be originals or true copies, such as photocopies, or other accurate
reproductions of the original records, or as electronic records.
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Draft 1
2.9.1 U.S. HEMP GUIDANCE – PROCESSOR - RECORD RETENTION CHECKLIST
√ if Applicable
ALLRECORDSARETOBEKEPTFOR5YEARS
DOTHERECORDSINCLUDETHEFOLLOWING? YES NO NOTES Name,addressandcountryoforigin?
Nameandlicenseofpersonwhogreworsoldtheseed?
Formoftheindustrialhempisimportedorprocessed?
Quantityofthehempimported,purchasedorsold?
Writtenproceduresforprocessing?
Writtenproceduresforpackagingandlabeling?
Processingrecordsincludingcomponents,ingredients,time,andlotorbatchnumber?
Packagingrecordsincludinglabels?
Destinationofhempsold,name,address?
Dateofshipment,nameofcarrier?
Quantityofhempshipped?
Resultsofanyandalltests?
Allavailableallimagesofproductsandlabels?
Anyandallcertificationdocuments?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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3 SERVICEPROVIDER
3.1 GENERALTERMS&DEFINITIONS ThefollowingDefinitionsandInterpretationsapplytosuchtermswhenusedinthisU.S.HempGuidanceProgram.Adulterationreferstoafoodthatmaybeconsideredadulteratedifitcontains"anypoisonousordeleterioussubstancewhichmayrenderitinjurioustohealth.....orifanyvaluableconstituenthasbeeninwholeorinpartomittedorabstractedtherefrom;or(2)ifanysubstancehasbeensubstitutedwhollyorinparttherefor;or(3)ifdamageorinferiorityhasbeenconcealedinanymanner;or(4)ifanysubstancehasbeenaddedtheretoormixedorpackedtherewithsoastoincreaseitsbulkorweight,orreduceitsqualityorstrength,ormakeitappearbetterorofgreatervaluethanitis".Batchmeansaspecificquantityofindustrialhempthatisuniform,thatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition,andthatisproducedduringaspecifiedperiodoftimeaccordingtoasinglemanufacturingrecord.Batchnumber,orlotnumbermeansanydistinctivegroupofletters,ornumbers,oranycombinationofthem,fromwhichthecompletehistoryoftheprocessing,packaging,labeling,and/orstorageofabatchorlotofindustrialhempproductcanbedetermined.Biomassmeanstheamountoflivingmatterinagivenhabitat,expressedeitherastheweightoforganismsperunitareaorasthevolumeoforganismsperunitvolumeofhabitat.Componentmeansanysubstanceintendedforuseinthemanufactureofindustrialhemp,includingthosethatmaynotappearinthefinishedbatchoftheindustrialhemp.GrowthMediummeansthesolid,liquidorsemi-solidsubstanceusedtosupportthegrowthoftheplant.Hempreferstocannabisvarietiesthatareprimarilygrownasanagriculturalcrop.HempplantsarelowinTHC(marijuana'sprimarypsychoactivechemical).Asestablishedin7U.S.C.§5940,industrialhempmusthaveadelta-9tetrahydrocannabinol(THC)concentrationofnotmorethan0.3percentonadryweightbasis,measuredfromanypartoftheplant.IndustrialHempmeansaplantofthegenusCannabisSativaLandanypartoftheplant,whethergrowingornot,containingadelta-9tetrahydrocannabinol(THC)concentrationofnomorethanthree-tenthsofonepercent(0.3%)onadryweightbasis.Ingredientmeansanysubstancethatisusedinthemanufactureofhempandthatisintendedtobepresentinthefinishedbatchofthehempproduct.In-processmaterialmeansanymaterialthatiscompounded,blended,ground,extracted,sifted,sterilized,derivedbychemicalreaction,orprocessedinanywayforuseinthemanufactureofthehempproduct.
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Lotmeansabatch,oraspecificidentifiedportionofabatch,or,inthecaseofahempproductproducedbycontinuousprocess,aspecificidentifiedamountproducedinaspecifiedunitoftimeorquantityinamannerthatisuniformandthatisintendedtomeetspecificationsforidentity,purity,strength,andcomposition.Microorganismsmeansyeasts,molds,bacteria,viruses,toxins,andothersimilarmicroscopicorganismswhichmayormaynothaveahealthorsanitaryconcern.Pestmeansanyobjectionableinsectorotheranimalincludingbutnotlimitedtobirds,rodents,flies,mites,andlarvae.Physicalplantorfacilitymeansalloranypartofabuildingorfacilityusedfororinconnectionwithmanufacturing,processingpackaging,labeling,orstorageofindustrialhempproductsoringredients.Processormeansmakingatransformativechangetothehempplantorproductfollowingharvest.Productcomplaintmeansanycommunicationthatcontainsanyallegation,written,electronic,ororal,expressingconcern,whichmayormaynothaveberelatedtothequalityofanindustrialhempproduct.Qualitymeansthatthehempproductmeetstheestablishedspecificationsforidentity,purity,strength,andcomposition,andlimitsoncontaminants,andhasbeenmanufactured,packaged,labeled,andheldunderconditionstopreventadulteration.QualityManagementSystemsmeansaplannedandsystematicoperationorprocedureforensuringthequalityofahempproduct.QualityManagementSystemspersonnelmeansanyperson,persons,orgroup,withinoroutsidetheorganization,designatedtoberesponsibleforqualitycontroloperations.Representativesamplemeansasamplewithanadequatenumberofunitsthatareintendedtoensurethatthesampleaccuratelyportraysthematerialbeingsampled.Reservesamplemeansarepresentativesampleofproductthatisheldforadesignatedperiodoftime.Sanitizemeanstoadequatelytreatcleanedequipment,containers,utensils,etc.byaprocessthatiseffectiveindestroyingofmicroorganismsofpublichealthconcerns.
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3.2 REGISTRATION/APPLICATION/NOTIFICATION
Prior to the Industrial Hemp Processor processing any seed or hemp product, a license or agreement with the State must be obtained. The following information is required to make the application before a license will be issued: (Each State may have different regulations – refer to application – See Kentucky Hemp Policy Guide as an example)
3.2.1 Registration/Application Guidance • Applicant’s contact information, including a copy of current driver’s license for applicant and
each proposed signing authority. • Full names of each individual who will be primarily responsible for the processing or handling
the applicant’s hemp material. • Research plan, including the estimated quantity of hemp material to be processed annually. • Address of each location and GPS coordinates of each building or site where hemp will be
stored, processed or handled. • Map(s) depicting each site where hemp will be processed, or stored, and designating
entrances and specific points where GPS coordinates were taken. • Seed/propagule acquisition plan, including a list of proposed affiliated growers. • Material acquisition plan, including a list of proposed affiliated growers. • Marketing plan, including the type of products to be marketed and to whom • Consent to all statements in the Acknowledgments Section in the Processor/Handler
Application. • Quality Management Systems
3.2.2 Notification of Changes to the licensor by the licensee Every licensee shall notify the State of any changes to the information provided on the application, within 15 days after the change, including:
• Corporate name or ownership or officers & and the replacement of an officer, or director • Any change to the address to the licensee • The replacement of an individual referred to on licensee • Any change in the mailing address of the licensee • Any change in the ownership of the land used to cultivate industrial hemp • Any change to the approved cultivar being sown or, in the case of a plant breeder to the
variety of industrial hemp being sown;
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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3.3 PERSONNELGUIDANCEQualifiedemployeeswhomanufacture,package,orlabelindustrialhempshouldbequalifiedtodosoandthoseresponsibleforqualitycontrolorperforminganyqualitycontroloperations,musthavetheeducation,training,orexperiencetoperformtheassignedfunctions.Supervisorsshouldbequalifiedbyeducation,training,orexperiencetosupervise.ContaminationPreventionandHygienicmeasuresshouldbetakentoexcludefromanyoperationsanypersonwhomightbeasourceofmicrobialcontamination.Suchmeasurescouldincludethefollowing:
• Excludingpersonnelfromworkinginanyoperationsthatmayhave,anillness,infection,openlesion,oranyotherabnormalsourceofcontamination.
• Instructingemployeestonotifytheirsupervisorifthereisapossibilitythattheyhaveahealth
conditiondescribedabove.• Wearingoutergarmentsinamannerthatprotectsagainstthecontamination.• Maintainingadequatepersonalcleanliness.• Washinghandsthoroughly,andsanitizingifnecessary,inahand-washingfacility.
• Removingorcoveringallunsecuredjewelryandotherobjectsthatmightfallinto
components,industrialhemps,equipment,orpackaging,• Usinggloveswhenappropriate.• Wearing,whereappropriate,hairnets,caps,beardcovers,shoes,PPE,etc.
Personnelandemployeesafetymeasuresshouldincludethefollowing:
• AppropriateandAdequateFirstAidEquipment
• Adequatebathroomsandchangingrooms
• AppropriateOSHAwarnings,labels,andtraining• Appropriatetrainingandpersonalprotectiveequipmentforpesticideapplication.
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3.3.1 U.S. HEMP GUIDANCE - SERVICE PROVIDER - PERSONNEL GUIDANCE CHECKLIST √ if Applicable
YES NO NOTES
Arethesupervisorsqualifiedfortheirresponsibilitiesbytraining,educationorexperience?
Dotheemployeesperformingthegrowing,processing,packagingandlabelingtasks,havethepropertrainingnecessarytoperformthetasks?
Arecontaminationandhygienicmeasuresinplacetoexcludepersonnelwhomightbeasourceofcontamination?
Arepersonnelexcludedfromoperationsiftheyhave,anillness,infection,openlesion,oranyotherabnormalsourceofcontamination?
Doemployeesnotifytheirsupervisorifthereisapossiblehealthconditionasdescribedabove?
Dopersonnelwearoutergarmentsinamannerthatprotectsagainstthecontamination?
Dooperatingpersonnelmaintainadequatepersonalcleanliness?
Arehandwashingfacilitiesavailableandused?
Dooperatingpersonnelremoveorcoverunsecuredjewelryetc.topreventthemfromfallingintohempproductsorcausingharm?
Areglovesusedwhenappropriate?
Arecaps,shoesandheadcoveringusedwhenappropriate?
IstheappropriatePersonalProtectiveEquipment(PPE)usedasneeded?
Arethereadequateandappropriatefirstaidequipmentavailable?
Isthereadequatebathroomsandchangingrooms?
AretheOSHAwarningsandsignsvisible?
Hastherebeenadequatetraining?
IfapplicableisthePPEandtrainsavailableforthepesticideapplicators?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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3.4 PHYSICALPLANTANDGROUNDSFacilitiesusedintheprocessing,packaging,labeling,orholdingofindustrialhempshouldbeadequateinsize,construction,anddesign.Facilitiesshouldbesuchtoprovideadequatespacefortheequipmentandmaterialsnecessaryfornormaloperationsaswellasmaintenance,cleaning,andsanitizingoperationsandtopreventcontamination.Equipmentthatcontrolstemperatureandhumidityaswellasfansandotherair-blowingequipmentusedshouldbeadequateforuse.Aislesorworkingspacesbetweenequipmentandwallsshouldbeadequatetopermitallpersonstoperformtheirduties.Adequatelightshouldbeavailableinallareasasneeded.Facilitiesshouldbemaintainedtoprotectagainstcontaminationofindustrialhemp.Facilitymaintenanceshouldincludefacilitiesinrepairsufficienttopreventindustrialhemps,orproductscontamination.Facilityshouldhaveadequatebathroomsandchangingrooms.Facilityshouldhaveasanitary/cleaningplanCleaningcompounds,sanitizingagents,pesticides,andothertoxicmaterialsneedtobefreefrommicroorganismsandthataresafeandadequateundertheconditionsofuse. PestcontrolincludesnotallowinganimalsorpestsinanyareaofyourfacilitiesexceptGuardorworkingdogs.Insecticides,fumigants,fungicides,herbicides,orrodenticides,shouldbeusedwithcareandintheintendedmanner.Watersupplyneedstobesafeandsanitary,atsuitabletemperatures,andunderpressureasneededforappropriateuse.Plumbinginthefacilityshouldbeofanadequatesizeanddesignandbeadequatelyinstalledandmaintainedtosatisfyoperationalneeds.
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Floordrainageshouldbeadequateforoperationsandtopreventcontaminationofindustrialhempproductsorcomponents.Sewagedisposalshouldbeadequateforoperationalneedsandbathrooms.Hand-washingfacilitiesshouldbeavailableanddesignedtoensurethatanemployee'shandsarenotasourceofcontaminationofhempproducts.Trashdisposalshouldbeadequatetominimizeodors,attractpestsorbecomeasourceofcontamination.Groundsshouldbemaintainedtoprotectagainstcontaminationofindustrialhemp.Groundmaintenanceincludes:
• Properlystoringequipment,removinglitterandwaste,andcuttingweedsorgrasssothatitdoesnotattractpests,harborpests,orprovidepestsaplaceforbreeding;
• Maintainingroads,yards,andparkinglotstopreventcontaminationofindustrialhemp
products
• Adequatelyoperatingwastetreatmentanddisposal.
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3.4.1 U.S. HEMP GUIDANCE – SERVICE PROVIDER - FACILITY & BIOSECURITY AWARENESS CHECKLIST A. Facility Security (physical security of buildings and grounds)
√ if Applicable
Is the facility using: YES NO NOTES
Security lighting Perimeter fencing Controlled gate access Off-hours security guard Electronic motion detectors Door alarms Video cameras Adequate indoor lighting Alarms linked to an off-site security system Door hardware is of industrial design Guards are installed on exterior ladders Exit doors and gate are electronically/mechanically secured Entry and discharge points of exterior tanks are padlocked
when not in use
All vehicles parked outside are locked Empty/loaded containers are parked inside Law enforcement patrol over company premises on regular
but unpredictable basis
Employees reporting any suspicious behaviors Restricted access to computer process control and data
systems
Safeguard of data systems using data security program Backup of all data and processes at an off-site place B. Visitor Policy
√ if Applicable
Is the facility using: YES NO NOTES
Company representative for visitor to check in with Signs informing visitors where to report Specific area for visitor parking Records of visitors (include name, company, arrival and
departure, and purpose of visit)
Visitor badges/identification cards Company representative to escort visitor all the time Restricted access to key manufacturing areas C. Distribution
√ if Applicable
Is the facility implementing the following: YES NO NOTES
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Bulk containers are inspected prior to loading for foreign and/or suspicious material
Verify that all customer pick-up drivers are representatives of the customer
The product stream is inspected visually Container access points are secured after loading Seal numbers are documented on the shipping papers Shipping documents are used to identify the contents of each
compartment
Shipping log is maintained Bio-sanitation program is implemented Procedures exist to disinfect vehicles and drivers D. Housekeeping
√ if Applicable
Is the facility implementing the following: YES NO NOTES
Written housekeeping program for all areas of the facility Written pesticide and rodenticide program E. Emergency Response
√ if Applicable
Is the facility implementing the following: YES NO NOTES
Employees are adequately trained to respond to a crisis as calmly and safely as possible
Current inventory of all hazardous and flammable products A plan to provided MSDS to emergency response teams etc. A list of emergency contacts is posted An action plan to deal with suspicious devices or substances Evacuation plan in case of fire and explosions is published Establish and maintain an up-to-date employee roster and
visitor log to facilitate personnel head count at any time
Disaster Preparedness Plan A weapons security program Conduct evacuation and respond drill periodically Post a site plan depicting escape routes, fire-fighting and
rescue equipment
Signature: _____________________________ Date: ________________________________
Printed Name: __________________________ Company: ________________________________
Facility Location: ________________________________
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3.5 EQUIPMENTEquipmentandmulti-useutensilsshouldbedesigned,andbuilt,tobesuitableforitsintendeduseandabletobeadequatelycleanedandproperlymaintained.Equipmentshouldbedesignedandbuildsothatusewillnotresultinthecontaminations.EquipmentshouldbeInstalledandmaintainedtofacilitatecleaningtheequipment,utensils,andalladjacentspaces.Equipmentshouldbemaintainedtoprotectindustrialhempfromcontaminations.EquipmentshouldhaveacertificateofInstallationQualification(IQ),OperationalQualification(OQ)andPerformanceQualification(PQ)Freezer,refrigerator,andothercoldstorageequipmentshouldhaveaworkingthermometer.Compressedairorothergasesshouldbeusedandbetreatedinsuchawaythattheindustrialhemp,orcontactsurfaceisnotcontaminated.Instrumentsandcontrolsusedinprocessing,packagingorlabelingortestingindustrialhempproductsshouldbecalibratedasnecessarytoassureaccuracy.Automated,orelectronicequipmentusedtomanufacture,package,label,orholdindustrialhemp,shouldbedesignedtoensurethatindustrialhempproductspecificationsareconsistentlymet.Equipmentshouldbeproperlycalibratedaccordingtothemanufacturesspecifications.Automated,mechanical,andelectronicequipment(includingsoftwareforacomputercontrolledprocess)shouldbeusedandoperatedbytrainedpersonalforproperuse.Utensilsintendedforone-timeuse,(papercups,andpapertowelsetc.)shouldbestoredinappropriatecontainers;anddisposedoftopreventcontamination.Cleaningmaterialsshouldbeapprovedandproperlylabeledforintendeduseandsafeundertheirconditionsofused.
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3.5.1 U.S. HEMP GUIDANCE – SERVICE PROVIDER – EQUIPMENT CHECKLIST √ if Applicable
YES NO NOTES
Istheequipmentandmulti-useutensilsdesigned,andbuiltforitsintendeduse?
Istheequipmentabletobeadequatelycleanedandproperlymaintained?
Istheequipmentdesignedandbuildsothatusewillnotresultinthecontaminations?
IstheequipmentInstalledandmaintainedtofacilitatecleaning?
Istheequipmentmaintainedtoprotectindustrialhempfromcontaminations?
DoestheEquipmenthaveacertificateofInstallationQualification(IQ),OperationalQualification(OQ)andPerformanceQualification(PQ)?
Doesthefreezer,refrigerator,andallcoldstorageequipmenthaveaworkingthermometer?
Isthecompressedairorothergasesusedinsuchawaythatthehemp,orcontactsurfaceisnotcontaminated?
Aretheinstrumentsandcontrolsusedinprocessing,packagingorlabelingfortestinghempproductscalibratedtoassureaccuracy?
Aretheautomated,orelectronicequipmentusedtomanufacture,package,label,orholdindustrialhemp,designedtoensurethathempproductspecificationsareconsistentlymet?
Aretheautomated,mechanical,andelectronicequipment(includingsoftwareforacomputercontrolledprocess)usedandoperatedbytrainedpersonalforproperuse?
Aretheutensilsintendedforone-timeuse,(papercups,andpapertowelsetc.)storedinappropriatecontainers;anddisposedoftopreventcontamination?
Arethecleaningmaterialsapprovedandproperlylabeledandstoredandusedundertheirconditionsofused?
IstheEquipmentproperlycalibratedaccordingtothemanufacturesspecifications?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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3.6 PACKAGINGANDLABELINGINDUSTRIALHEMPPackagingandLabelingproductsreceived,butnotprocessed,shouldhaveacontrolsystemtoexamineeachcontainertodeterminethattheappropriateproductwasreceived,contentlabeled,andthatthecontainerhadnodamage,contaminationordeteriorationofthecomponents.3.6.1 Guidance for packaging and labeling operations Packagingandlabelingoperationsshouldbesuchthattheconditionofthepackagingwillensurethequalityoftheindustrialhempproducts.Issuanceanduseofpackagingandlabelsshouldbecontrolledandrecorded.Packagingandlabelsforeachlotorbatchofindustrialhempshouldbedocumentedtodeterminewhetherthepackagingandlabelsconformtothemanufacturingrecord.Packagedandlabeledindustrialhempshouldbedocumentedthroughdistribution.Packaging,labeling,andotherrelatedoperationsshouldensurethatthequalityoftheindustrialhempproductsarepackagedandlabeledasspecifiedinthemanufacturingrecord,includingthefollowing:• Cleaningandsanitizingallfillingandpackagingequipment,asappropriate.• Protectingindustrialhempsfromcontamination,includingairbornecontamination.• Usingsanitaryhandlingprocedures.• Establishingphysicalorspatialseparationofpackagingandlabeloperationsfromoperationson
othercomponents.• Identifyingcontainersthataresetasideandheldinunlabeledcondition.
• Assigningabatch,lotnumbertoeachlotofpackagedandlabeledindustrialhempfromafinished
batchofindustrialhemp.Representativesamplesofeachbatchofthepackagedandlabeledindustrialhempshouldbekepttodeterminewhethertheproductmeetsspecifications.Suitablydisposingoflabelsandpackagingwhichareobsoleteorincorrecttoensurethattheyarenotusedinanyfuturepackagingandlabeloperations.
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Recordsshouldbekeptofthewrittenproceduresforpackagingandlabelingoperations.Managementshouldapprovethehempproductsforfinaldistribution/sale.3.6.2 Quality control procedures should include: Determinewhetherthereceivedproductmeetstheproductspecification.Approvalofthecomponentsforuseinthepackagingandlabelingofanindustrialhempproduct.Identifyingeachuniquelotwithineachshipmentofcomponentsreceivedsothatitcanbetrackedthroughthepackaging,labeling,marketinganddistributionprocesses.Storageofthecomponentsshouldbeunderconditionsthatwillprotectagainstcontaminationanddeterioration.Collectionofarepresentativesampleofeachlot.Holdpackagingmaterialandlabelsunderconditionsthatwillprotectagainstcontaminationanddeterioration.
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3.6.3 U.S. HEMP GUIDANCE – SERVICE PROVIDER - PACKAGING AND LABELING CHECKLIST √ if Applicable
YES NO NOTES
Isthereapackagingandlabelingplantoexamineallincomingcomponentsandingredients?
Doesthepackagingandlabelingplandeterminethattheproductreceivedmeetstheappropriateproductdescription?
Doesthepackagingandlabelingplandeterminethecontainerdamageorcontamination?
Dothepackagingandlabelingoperationsensurethequalityoftheindustrialhempproducts?
Aretheissuanceanduseofpackagingandlabelstotheproperpersonalcontrolledandrecorded?
Arethepackagingandlabelsforeachlotorbatchofhempdocumentedtothatthepackagingandlabelsconformtothemanufacturingrecord?
Arethepackagedandlabeledhempproductsdocumentedthroughdistribution? Arethepackagingandlabelingequipmentcleanedandsanitizedasappropriate? Doesthepackagingandlabelingequipmentprotecthempagainstall
contamination?
Aresanitaryhandlingproceduresbeingused? Istherephysicalorspatialseparationofpackagingandlabeloperations
implemented?
Areallcontainersidentifiedthataresetasideandheldinunlabeledconditionforfutureuse?
Isalotorbatchnumberoneachpackageofhemp? Isarepresentativesampleofeachbatchofthepackagedandlabeledhemp
productkepttodeterminewhethertheproductmeetsspecifications?
Isobsoleteorincorrectmaterialproperlydisposedoftopreventfutureuse? Arerecordskeptofthewrittenproceduresforpackagingandlabelingoperations? Doqualitycontrolproceduresdeterminewhetherthereceivedproductmeetsthe
productspecification?
Isthereanapprovalprocessforthecomponentsforuseinthepackagingandlabelingofhempproduct?
DothequalitycontrolproceduresIdentifyeachuniquelotwithineachshipmentofcomponentsreceivedsothatitcanbetrackedthroughthepackaging,labeling,marketinganddistributionprocesses?
Storageofthecomponentsshouldbeunderconditionsthatwillprotectagainstcontaminationanddeterioration?
Istherearepresentativesampleofeachlot? Arethepackagingmaterialsandlabelsheldunderconditionsthatwillprotect
againstcontaminationanddeterioration?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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3.7 STORAGEANDDISTRIBUTIONStorageofindustrialhempshouldbeinunderappropriateconditionsoftemperature,humidity,andlightsothattheidentity,purity,strength,andcompositionofthecomponentsandindustrialhempsarenotaffected.StorageofhempandhempproductsshouldbeproperlylabeledatalltimestopreventcontaminationsandunintendedcominglingStorageofhempandhempproductsshouldbeproperlylabeledtoindicateaholdoravailableforrelease.Storageofmaterialin-processshouldbeidentifiedunderconditionsthatpreventmix-ups,contamination,anddeterioration.Storageofmaterialin-processshouldbeheldunderappropriateconditionsoftemperature,humidity,andlight.Storageofpackagingandlabelsshouldbeunderconditionsadequatetopreventthepackagingandlabelsfrombeingadverselyaffected.Distributionofhempproductsshouldbeunderconditionsthatwillprotecttheproductsagainstcontaminationanddeterioration.
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3.7.1 U.S. HEMP GUIDANCE - SERVICE PROVIDER – STORAGE & DISTRIBUTION CHECKLIST √ if Applicable
YES NO NOTES
Istheindustrialhempandhempproductsstoredorwarehousedunderappropriateconditions?
Arethestorageconditionssufficienttopreventadulteration?
Arethestorageconditionssufficienttopreventchangesinspecificationsofthehempproducts?
Isthematerialusedin-processheldunderadequateconditionstopreventchangesinthecomponentsoringredients?
Arethepackagingmaterialsstoredandheldinconditionstopreventdeterioration?
Arethelabelsandlabelingmaterialsstoredandheldinconditionstopreventdeterioration?
Isthehempdistributionplanadequatetopreservethequalityofthehempproducts?
Isthehempdistributionplanadequatetoassurethatthehempproductsareshippedtotheintendedplaceandtotheintendedrecipient?
IstheStorageofhempandhempproductsproperlylabeledatalltimestopreventcontaminationsandunintendedcomingling?
IstheStorageofhempandhempproductsproperlylabeledtoindicateaholdoravailableforrelease?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________
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3.8 RECORDRETENTIONProcessor, packagers and labelers should keep records, electronically or hard copy that contain the following information for at least five (5) years after process or operations • Source of the industrial hemp seed (imported or purchased or grown), name and address and the
country of origin. • Form in which the industrial hemp is imported or processed. • Quantity of each form of industrial hemp imported, purchased or sold. • Destination of the industrial hemp that is sold, name and address of the purchaser and the
country, to which it is exported. • Date that each shipment of industrial hemp is sent or received.
• Name of the carrier, • Results of any tests, • Quantity shipped,
• Written procedures of production processes. • If available all images of products and labels • Processing records including the time the operations were performed. the components,
packaging, labels, or products used and the batch or lot number for the finished product. • Any and all certification documents • Records kept should be originals or true copies, such as photocopies, or other accurate
reproductions of the original records, or as electronic records.
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Draft 1 3.8.1 U.S. HEMP GUIDANCE – SERVICE PROVIDER - RECORD RETENTION CHECKLIST
√ if Applicable
ALLRECORDSARETOBEKEPTFOR5YEARS
DOTHERECORDSINCLUDETHEFOLLOWING? YES NO NOTES Name,addressandcountryoforigin?
Nameandlicenseofpersonwhogreworsoldtheseed?
Formoftheindustrialhempisimportedorprocessed?
Quantityofthehempimported,purchasedorsold?
Writtenproceduresforprocessing?
Writtenproceduresforpackagingandlabeling?
Processingrecordsincludingcomponents,ingredients,time,andlotorbatchnumber?
Packagingrecordsincludinglabels?
Destinationofhempsold,name,address?
Dateofshipment,nameofcarrier?
Quantityofhempshipped?
Resultsofanyandalltests?
Allavailableallimagesofproductsandlabels?
Anyandallcertificationdocuments?
Signature: _____________________________ Date: ________________________
Printed Name: __________________________ Company/Location: ________________________