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COMMONWEALTH of VIRGINIA (Virginia Department of Motor Vehicles)

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COMMONWEALTH of VIRGINIA
Department of Agriculture and Consumer Services
PO Box 1163, Richmond, Virginia 23218 www.vdacs.virginia.gov
ManufacturerofanIndustrialHemp‐DerivedExtractIntendedforHumanConsumption
GeneralInformation
Thankyouforyourinquiryregardingtheproductionofanindustrialhemp‐derivedextractintendedforhuman
consumptioninVirginia.Thefollowingdocumentsareenclosed/attached,orareavailableattheVDACS
websiteforyou:
● VDACSApplication–IndustrialHemp‐DerivedExtractProcessingOperation
● VirginiaFoodLaws
● 21CFR117
CurrentGoodManufacturingPractice,HazardAnalysis,andRisk‐BasedPreventiveControls
forHumanFoods
● “HowTo”documentforcompletingthisapplicationandpreparingforyourinspection
If,afterreviewingtheapplicationandothermaterials,youhaveanyquestions,pleasecontacttheVDACSFood
SafetyProgramat804‐786‐3520orfoodsafety@vdacs.virginia.gov.
Pleasebeadvisedthatsection3.2‐5130oftheVirginiaFoodLawrequiresthatyourfoodprocessingand
storageareasbeinspectedpriortostartingyourfoodoperation.Aninspectionofyouroperationwillnotbe
conducteduntilallofthenecessaryinformationrequestedintheapplicationhasbeenreviewedandapproved
bytheVDACSFoodSafetyProgramoffice.Youwillbenotifiedwhenthishasbeencompleted.
Also,thereisa$40.00feeforoperatingafoodprocessingbusiness.Youwillnotberequiredtopaythisfeeat
thetimeofyourinitialinspection;however,youwillreceiveabillduringournextbillingcycle.
Sincerely,
PamelaMiles
ProgramSupervisor
FoodSafetyProgram
VirginiaDepartmentofAgriculture&ConsumerServices
-Equal Opportunity Employer-
J
ewel H. Bronau
g
h, Ph.D.
Commissioner
ApplicationforManufacturerofanIndustrialHemp‐
DerivedExtractIntendedforHumanConsumption
DateofApplication:
IndustrialHempProcessor
RegistrationNumber:
Countyinwhich
businessislocated:
BusinessName:
OwnerName:
Phone:
EmailAddress:
ProcessingLocation
Address:
BusinessMailing
Address:
WaterSupply: Public Private Type(drilled,bored,etc)
SewageDisposal: Public Private
Pets(ifoperatingin
thehome):
Yes No
Numberofemployees,includingowner:
Hoursofoperation:
ChecklistofRequiredInformation
Documentationofzoningapprovaltooperateafoodprocessingbusinessontheproperty
Documentationthatthehemp‐derivedextractsintendedforhumanconsumptionareproducedfromindustrial
hempgrownincompliancewithfederalorstatelaw
Documentationthatthehemp‐derivedextractsintendedforhumanconsumptionhaveatetrahydrocannabinol
(THC)concentrationofnogreaterthan0.3percent
Provideacertificateofanalysisifthelabelstatesthatanyamountofcannabinoidsarepresentinthefinished
product
Diagramofprocessingandstorageareas
Ifprivatewatersupplyisused,acopyofwatertestresultsshowingColiformbacteriaare“absent”
Documentationthattheprivatesewagedisposalsystemisadequateforintendeduse
Documentationofemployeetraining
Ifoperatinginthehome,providewrittenexplanationofhowcontaminationwithpersonalbelongingswillbe
prevented
Writtenproceduresforpreventingallergencross‐contact
Ifapplicable,additionaldocumentationrequiredunderSubpartsC&Gunder21CFR117
Listofallproductssubmittedforreviewwithplannedmethodandplaceofdistribution
Listofallingredientsusedinyourbusiness,withthesourceofeach
Productinformationsheetforeachproduct
Copyoflabelforeachproduct
July 2020
1
ApplicationInstructions
1. ReviewtheHowTodocumentforcompletingthisapplicationandpreparingforyourinspection.
2. Completepage1,providingalloftherequestedbasicbusiness/ownerinformation.Pleasedonotsubmityour
applicationwithoutanyoftherequiredinformationasitwillnotbereviewedwithoutit.Submitallofittogetherat
thesametime.
● Noteaboutpetsinthehome:Ifyoumarked“Yes”,areaswherefoodisprepared,orstored,wherepackaging
materialisstoredandwhereequipmentiscleanedandstoredmustbecompletelyenclosed/separatedfromthe
restofthehomeinordertobeconsideredforhomebasedfoodmanufacturing.Petsmustbeexcludedfrom
theseareasatalltimes.Forexample,foodprocessingandstorageareasmustbefittedwithasolidhinged
door(s)thatcanbelatched/closedshut.Placingpetsinclosedroomsinotherareasofthehomeorinstalling
"babygates"willnotsatisfythisrequirement.
● Noteonhoursofoperation:inspectionsareunannouncedandunscheduled.Providealistoftheweekdaysand
timesthatoperationwouldnormallyoccur.Theinspectorwillvisitforinspectionduringthesehours.
3. Providewrittendocumentationthatyouhaveapprovalfromthelocality’szoningofficetooperateafood
processingbusinessontheproperty.Alternatively,ifyouareusingacommunitykitchen,providewritten
documentationthatyouhavetheoperator’spermission.Anyverifiabledocumentationisacceptable,suchas
emailcorrespondence,officialletterorother.
4. Provideadiagramofthefoodprocessingandstorageareas.
5. Ifthepropertyisusingaprivatewatersupply(e.g.well),youmustprovideevidencethatthewaterispotable.A
recentcopy(lessthansixmonthsold)oflabresultsshowingthatColiformbacteriawere“absent”inasampleof
yourwellwaterisrequired.ThetestinglaboratorythatyouusemustbecertifiedbytheVirginiaSafeDrinking
WaterProgram.Alistoflabsthatarecertifiedforwatertestingcanbefoundatthislink:VirginiaSafeDrinking
WaterCertifiedLaboratories
6. Ifprivatesewagedisposalisused,obtaindocumentationfromanAlternativeOnsiteSoilEvaluator(AOSE),
ProfessionalEngineer(PE)orVirginiaDepartmentofHealththatyoursystemisadequatefortheintendeduseof
yourbusiness.Pleaseseehttps://drive.google.com/open?id=1nIVtqik9hDqAfzsaJX8J35dnknIG3SvI&usp=sharingfor
additionalinformationandtolocateaserviceprovider.NOTE:Allserviceprovidersmustbeproperlylicensed
throughtheDepartmentofProfessionalandOccupationalRegulation(DPOR).
7. Asafoodmanufacturer,youandanyemployeesofyourbusinessmustbetrained,andyoumustprovide
documentationofsaidtraining.Providedocumentationthatyouandanyemployeeshavereceivedtraininginthe
principlesoffoodhygieneandfoodsafety,includingtheimportanceofemployeehealthandpersonalhygiene,as
appropriatetoyourfoodproducts,yourfacilityandtheemployee’sassignedduties.Alistofsuggestedcoursesis
providedwithinthisapplication,butyoumayobtaintrainingelsewhereaslongasitisadequate.Alsoprovidedisa
templateyoumayusetodocumentemployeetraining.Eveniftheowneristheonlyemployee,atrainingrecord
needstobemaintained.
8. Providealistofallproductsyouplantomake,aswellastheplannedlocationofdistribution.
9. Providealistofalloftheingredientsyouwillbeusing,andthesourceofthoseingredients.
10. CompleteaProductInformationSheetforeachproductyouplantomake.Mark“TradeSecret”ifyour
formulation/processisconfidential.Wewillnotshareyourprocess,butyoumustprovideit.
11. Provideacopyofthelabelforeachproduct(mocklabelsareacceptableifactuallabelshavenotyetbeen
made).Labelsmustcomplywiththelabelingregulations,21CFR101.
12. SubmitapplicationstotheVDACSFoodSafetyProgram.Anincompleteapplicationwillcausedelayinitbeing
processed.Hand‐writtenapplicationswillnotbeaccepted.
Byemail(preferred):foodsafety@vdacs.virginia.gov
Bymail:ATTN:FoodSafetyPOBox1163Richmond,VA23218
Byfax:804‐371‐7792
13. Onceyourapplicationissubmitted,itwillbereviewed,andyouwillbecontactedbythereviewerifthereareany
questions.Whentheapplicationreviewiscomplete,aFoodSafetySpecialistwillcontactyoutoschedulethe
initialinspection.
14. Ifyoudonotprovidearesponsetothereviewer’scommentswithinfourmonths,yourapplicationwillbe
discarded.Anewapplicationwillneedtobesubmittedifyouwishtocontinue.
July 2020
2
RequirementsforManufacturersofIndustrialHempExtracts
Inordertoproduceahemp‐derivedextractintendedforhumanconsumptionaregisteredhempprocessor:
● Mustbeabletoprovidedocumentationthatthehemp‐derivedextractsintendedforhumanconsumptionare
producedfromindustrialhempgrownincompliancewithfederalorstatelaw.
● Mustbeabletoprovidedocumentationthatthehemp‐derivedextractsintendedforhumanconsumptionhave
atetrahydrocannabinol(THC)concentrationofnogreaterthan0.3percent.
● Shallmeetthestandardsstatedbelow,whicharestandardsthatareincludedintheregulationspromulgatedby
theVirginiaBoardofPharmacyfortheproductionofthecannabidioloilproductthatitregulates.
Microbiologicals
Ahemp‐derivedextractintendedforhumanconsumptionshallsatisfythestandardssetforthinSection
1111oftheUnitedStatesPharmacopeia.
Mycotoxins HeavyMetals
AflatoxinB1 <20ug/kgofSubstance Arsenic <10partspermillion(ppm)
AflatoxinB2 <20ug/kgofSubstance Cadmium <4.1ppm
AflatoxinG1 <20ug/kgofSubstance Lead <10ppm
AflatoxinG2 <20ug/kgofSubstance Mercury <2ppm
OchratoxinA <20ug/kgofSubstance
ResidualSolvents
Ahemp‐derivedextractintendedforhumanconsumptionshallmeetthestandardsandlimits
recommendedbytheAmericanHerbalPharmacopoeiaforCannabisInflorescence.
● Onlyresiduefrompesticidesthatmeetthefollowingrequirementsmaybepresentinahemp‐derivedextract
intendedforhumanconsumption:
1. Theactiveingredientisexemptfromtherequirementsofapesticidetoleranceonallfoodcrops(i.e.,auxins,
selectbiopesticides,copper,cytokinins,gibberellins,petroleumoil,phosphorousacid,pyrethrins,soap,
sulfur,commonconsumerfoodcommodities,ediblefats,andoils).Informationregardingfoodtolerances
forpesticideingredientsmaybefoundontheU.S.EnvironmentalProtectionAgency’s(EPA)website;and
2. Thelabelhasdirectionsforuseonunspecifiedfoodcrops(e.g.,beddingplants);and
3. ThepesticideisregisteredbyEPAorexemptedfromregistration;and
4. ThepesticideisregisteredbyVDACS;and
5. Thelabellanguageissufficientlybroadtoincludehempanddoesnotspecificallyprohibititsuseonhemp.
● Mustbeabletoprovideacertificateofanalysisifthelabelstatesthatanyamountofcannabinoidsarepresent
inthefinishedproduct.
● Complywiththefoodlawsandregulationspertainingtofoodmanufacturing,including21CFRPart110,Current
GoodManufacturingPracticeinManufacturing,Packing,orHoldingHumanFood(GMP).
● ComplywithCurrentGoodManufacturingPracticeinManufacturing,Packaging,Labeling,orHoldingOperations
forDietarySupplements(21CFR111)iftheindustrialhemp‐derivedextractproductappearstobelabeledor
marketedasaDietarySupplement.
July 2020
3
Zoning/CommercialKitchenApproval
Includeyourzoningapprovalhereoronaseparatesheet.
July 2020
4
Diagramoffoodprocessingandstorageareas
Thediagrammaybedrawnusingcomputersoftwareordrawnbyhand.Clearlyindicateorlabeleacharea
usedforstorageofrawingredients,packagingmaterials,finishedproducts,processingarea,warewashing
facilities,handwashingsinks,restrooms,etc.
EXAMPLE
July 2020
5
FoodProcessingandStorageAreaDiagram
Includeyourdiagramhereoronaseparatesheet.
July 2020
6
EmployeeTrainingandRecords
Anadequateandcompletetrainingcoursewouldincludetopicsonemployeehealthandhygiene,properfood
storageandcookingtemperatures,cleaningfoodcontactsurfaces,allergenawareness/controlandanyother
topicsspecificallyapplicabletoyourparticularfoodprocessingoperation.Providedocumentationthattraining
wascompletedonaseparatesheet.
Listofavailabletrainings:
● 360training.com,Inc.
Learn2ServeFoodProtectionManagerCertificationProgram:
Websitelink:https://www.360training.com/course/ansi‐food‐safety‐manager‐principles‐training‐
and‐exam
(877)881‐2235
● AboveTraining/StateFoodSafety.com
CertifiedFoodProtectionManager(CFPM)Exam:
Websitelink:https://www.statefoodsafety.com/food‐safety‐manager‐certification#/
(801)494‐1416
● NationalRegistryofFoodSafetyProfessionals
FoodManagerCertification
Websitelink:https://www.nrfsp.com/exam‐center/training‐options/
(800)446‐0257
● NationalRestaurantAssociation
ServSafeFoodProtectionManagerCertificationProgram
https://www.servsafe.com/ServSafe‐Manager
(800)424‐5156
● TheAlwaysFoodSafeCompany,LLC
FoodProtectionManagerCertification
https://alwaysfoodsafe.com/food‐protection‐manager
844‐312‐2011
● InstituteforFoodSafetyatCornellUniversity
GoodManufacturingPracticesPart117OnlineCourse
https://instituteforfoodsafety.cornell.edu/trainings/good‐manufacturing‐practices‐registration/
Exampletemplate:
EmployeeTrainingRecord
Grannie’sCookies111HappyLnAnytown,VA22554
EmployeeName CourseName Location DateCompleted TrainerSignature






July 2020
7
EmployeeTrainingandRecords
Includeacopyofyourtrainingrecordanddocumentationhereoronaseparatesheet.
July 2020
8
PreventingContaminationfromPersonalBelongings*
Theregulationstatesthatclothingorotherpersonalbelongingscannotbestoredinareaswherefoodisexposed
orwhereequipmentorutensilsarewashed.Youneedtoensurethatyoucanmeetthisrequirementinyourhome
kitchen.Personalbelongingsareanyitemsthatarenotusedinthemanufacturingofyourfoodsthatwillbe
offeredforsaletothepublic.Inaddition,theregulationalsostatesthateatingfood,chewinggum,drinking
beveragesorusingtobaccocannotoccurinareaswherefoodisexposedorwhereequipmentorutensilsare
washed.Thismeansthatduringthehoursthatyourhomeisusedasafoodmanufacturingfacility,allareasmust
havefirstbeencleanedandsanitizedandthatallpersonalbelongingsmustberemovedfromthecountertop,
tables,etc.wherefoodwillbemanufactured.Compliancewiththeserequirementswillbeverifiedbythe
inspector.
*Thissectionisonlyrequiredifyouareprocessinginyourhome.
Provideyourwrittenexplanationdescribinghowyouwillcomplyhereoronaseparatesheet.
July 2020
9
PreventingAllergenCross‐Contact
TheeightmajorallergensintheU.S.are:milk,wheat,eggs,peanuts,treenuts,soybeans,fish,andcrustacean
shellfish.Preventingaccidentalinclusionofallergensintoproductsthatshouldnotcontainthemiscriticaltothe
safetyofyourfoodproducts.Crosscontactoccurswhenanallergenfromonefood(walnuts,forexample)is
transferredtoanotherfoodthatdoesnotcontaintheallergen(strawberryjam,forinstance).Youshouldconduct
afoodallergeningredientanalysis.Ifyouranalysisidentifiesfoodallergensthatwill(ormaybe)inyourproducts,
youmusthavecontrolsinplacethatpreventallergencrosscontactthatincludesalltheproductsyou
manufactureforsale.Whenyouoperateinaspacethatisalsousedforotherbusinesses,youmustalsoconsider
foodsthattheystoreandprepare.Includingastatementonyourproductlabelsuchas“maycontain[peanuts],
[treenuts],[fish]…”isnotanadequatecontrolforpreventingcrosscontact.
Thefollowingresourcesmayhelpyouindevelopingaplan:
● https://www.foodsafetymagazine.com/magazine‐archive1/december‐2003january‐2004/writing‐and‐
implementing‐an‐allergen‐control‐plan/
● https://farrp.unl.edu/3fcc9e7c‐9430‐4988‐99a0‐96248e5a28f7.pdf
● https://www.fda.gov/media/129670/download
Provideyourwrittenplanforpreventingallergencrosscontacthereoronaseparatesheet.
July 2020
10
RequirementsofSubpartsC&GandExemptions
WhoisnotsubjecttotherequirementsofSubpartsCandG?
● VerysmallbusinessesthathaveattestedtoFDA.Averysmallbusinessisonethataverageslessthan
$1,000,000insalesofhumanfoodperyearfor3years.Usetheinstructionsandform3942aatthiswebsiteto
submityourattestation:https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐
documents/guidance‐industry‐determination‐status‐qualified‐facility
● Facilitieswhoexclusivelyhandleormanufactureseafood,juice,dietarysupplements,oralcoholicbeverages.
Toclarify,ifyourfacilityhandlesanyoftheaboveproducts,plusothercommodities,thenyouaresubjectto
SubpartsCandG.
● Homefoodprocessors

Ifyoudonotmeetanyoftheaboveexemptions,youmustcomplywithandsubmitthefollowing:
SubpartC:HazardAnalysisandRisk‐BasedPreventiveControls
Thissubpartappliestoallbusinessesnotinthelistabove,whichisthevastmajorityoffoodmanufacturers.
FacilitiesthataresubjecttothissubpartmusthaveawrittenandimplementedFoodSafetyPlan(FSP).TheFSP
mustbeoverseenbyaPreventiveControlsQualifiedIndividual(PCQI).TheFSPmustincludethefollowing:
● Hazardanalysis ● Monitoringprocedures
● Preventivecontrols ● Correctiveactionprocedures
● Supplychainprogram ● Verificationprocedures
● Recallplan
PreventiveControlsQualifiedIndividuals(PCQI)
PreventiveControlsQualifiedIndividualmeansaqualifiedindividualwhohassuccessfullycompletedtrainingin
thedevelopmentandapplicationofrisk‐basedpreventivecontrolsatleastequivalenttothatreceivedundera
standardizedcurriculumrecognizedasadequatebyFDAorisotherwisequalifiedthroughjobexperienceto
developandapplyafoodsafetysystem.
Foradditionalinformationvisit:https://www.ifsh.iit.edu/fspca
SubpartG:Supply‐ChainProgram
Thissubpartoutlinestherequirementsforasupplychainprogram.Thesafetyoftheproductyoumanufacture
notonlydependsonthecontrolsyouputinplace,butthecontrolsappliedbyyoursuppliersoryourcustomers.If
aknownhazardexistsinyourproductoringredients,itneedstobecontrolled,whetherthatbeatyoursupplier's
facility,atyourfacility,orbythenextfacilityinthesupplychain.Ifyoudecidethatthehazardwillnotbe
controlledatyourfacility,thenyoushouldidentifyasupplychaincontrolinyourhazardanalysis.Ifyoudoso,you
willneedtoimplementsupply‐chaincontrolwhichmayincludeusingapprovedsuppliersandconducting
verificationofthesesuppliers.
ResourcesforCreatingYourFoodSafetyPlan
FoodSafetyPreventiveControlsAlliance:https://www.ifsh.iit.edu/fspca
FDA:https://www.fda.gov/food/food‐safety‐modernization‐act‐fsma/fsma‐final‐rule‐preventive‐controls‐
human‐food
VirginiaTechFoodInnovationsProgram:JoellEifert,Directorfoodbiz@vt.eduor(540)231‐5770
July 2020
11
FoodSafetyPlanandSupply‐ChainProgram
IncludeacopyofyourFoodSafetyPlanandSupply‐ChainProgramhereoronaseparatesheet.Ifyouareavery
smallbusiness,includedocumentationyouhaveattested.

July 2020
12
BasicLabelingRequirements
Thefollowingarelabelingcomponentsrequiredforallpackagedfoods.Failuretoprovidelabelsasdescribed
belowwillcauseyourapplicationtobereturned.Refertothelabelingregulation21CFR101forcomplete
details.
ProductName:NetWeight:
MustbeonthefrontpanelMustbeonthefrontpanel
Mustbeanaccuratedescriptionoftheproduct Mustbestatedinbothstandardandmetricunits
MustbeinboldprintMustbeinboldprint
Mustbethelargesttypeonthepanel Mustbelocatedonthebottomofthepanel
IngredientsStatement:Mustappearonthesamepanelasthenameandaddressofyourbusiness.Itmustbeon
thefrontpanelorthepaneldirectlytotherightofthefrontpanel.Ingredientsmustbelistedinorderofheaviest
toleastheavy.Ifanyingredientismadeoftwoormoreingredients, these“sub‐ingredients”must belistedin
parentheses next tothe main ingredient. When oneof the eight major foodallergens is an ingredientor sub‐
ingredient,itmustbeidentifiedbyname,eitherwithintheingredientstatementORinaseparatestatementdirectly
belowtheingredientstatement.Thisiscalleda“containsstatement”andmustfollowtheformatshownbelow.
Theonlywordsthatmaybeusedtoidentifytheallergensarethefollowing:Milk,Wheat,Eggs,Peanuts,TreeNuts
(namethespecifictypeofnut),Soybeans,Fish(namethespecificspeciesoffish),andCrustaceanShellfish(name
thespecificspeciesofcrustacean).
Allergens*listediningredientstatement: Allergens*listedincontainsstatement:
Nameand Addressof Manufacturer, Distributor,or Packer:Must appearonthe samepanelas theingredient
statement.Itmustbeonthefrontpanelorthepaneldirectlytotherightofthefrontpanel.Theaddressofthe
businessmustbelistedinfull—streetname,city,stateandzip.APOBox,telephonenumber,emailaddress,website
addressorothercannotsubstitute.
Noclaimscanbemadeontheproductlabeltotheproduct’ssuggesteduseorpotentialhealthbenefitsunless
youintendtocomplywiththedietarysupplementregulation,21CFR111(inadditionto21CFR117).Noclaims
canbemadesuggestingtheproductis intendedforuseinthediagnosis,cure,mitigation,treatment,or
preventionofdisease,asstatementsindicatingsuchusewouldcausetheproducttobeclassifiedasadrug
ratherthanafood.
Pleasebeawarethatlabelingincludesstatementsorimagesontheproductpackaging,
businesswebsiteorsocialmedia,flyers,newslettersoranyotherprintedmaterialnotexplicitlymentioned
here.
EXAMPLELABEL
FullSpectrumHempExtract
Ingredients:HempSeedOil,FractionatedCoconutOil,FullSpectrumHempExtract.
GrassyFieldsHempCompanyLLC
14740CountryRoad
Somewhere,VA24019
1floz(30ml)
Note:Ifyourproductwillbeadietarysupplement,additionallabelingrequirementswillbeapplicable.Please
contactVDACSFoodSafetyformoreinformation.
Ingredients:HempSeedOil,CoconutOil,Full
SpectrumHempExtract.
Ingredients:HempSeedOil,CoconutOil,Full
SpectrumHempExtract.Contains:Coconut
OR
July 2020
13
ProductListandPlannedDistribution
Productssubmittedforreview Planneddistribution





IngredientListandSource
IngredientName IngredientSource












July 2020
14
ProductInformationSheet
BusinessName: Date:
ProductName: TradeSecret:
ListofIngredients:
ProcessingProceduresfromrawingredientstofinishedproduct:
July 2020
15
Click here for additional Product Information Sheets in Microsoft Word
ProductLabel
Includeacopyofyourlabelhereoronaseparatesheet.
July 2020
16
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COMMONWEALTH of VIRGINIA (Virginia Department of Motor Vehicles)

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Completed 7 June 2022

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