Commercial Kitchen‐Based
FoodBusiness
CompletingthePermit ApplicationforaCommercialKitchenFoodProcessing
Operationandwhattoexpectduringyourfoodsafetyinspectionatthecommercial
kitchen.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 1 of 59
ApplicableLawsandRegulations
Asafoodproducer,youarerequiredtomeetcertainstandards.
Thefollowingregulationsaremostapplicabletoyourfood
business.Youshouldfamiliarizeyourselfwiththeseregulationsto
preparefortheinspectionandtoeducateyourselfonhowto
providesafe,wholesomefoodtoyourcustomers.
VirginiaFood and DrinkLaw
21CFR117CurrentGoodManufacturingPractices
21CFR101FoodLabeling
* Pleasenotethatadditionalregulationsmayapplydependingon
theproductyouaremanufacturing*
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page1oftheApplication
BusinessName:Enterthenameofyourbusiness
OwnerName:Enteryourfull,legalname
Phone:Enterthephonenumbertobestreachyou
EmailAddress:Entertheemailaddresswhereyouwouldlikeustoreachyou
NameofCommercialKitchen:Enterthenameofthesharedcommercialkitchen
CommercialKitchenAddress:Enterthephysicaladdressofthecommercialkitchen
Countyinwhichcommercialkitchenislocated:EntertheCountyorCityinwhichthe
kitchenyou’lluseforproductionislocated
YourBusinessMailingAddress:Enterthenameofyourbusinessandtheaddress
whereyouwouldliketoreceivemailcorrespondence.Thislikelywillnotbethesame
asthecommercialkitchenaddress.
WaterSupply:Markwhethertheincomingwatersupplyisfromapublicsource,like
thecity’swaterworks,orifthereisaprivatewatersupplylikeawell.
SewageDisposal:Markwhetherthewastewaterisdisposedofintoapublicsystem,
likethecity’swastedisposal,orifthereisaprivatedisposalsystem,likeaseptictank.
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CompletingtheApplication
Page1oftheApplication
Numberofemployees,includingowner:Enterthenumberofemployeesforyour
business,includingyourself.
Hoursofoperation:Entertheweekdaysandtimesthatyouroperationwouldnormally
occur.
Percentageofingredientsreceivedfromoutofstatesuppliers:Enterthepercentage
ofrawmaterialsthatoriginatedinanotherstate,territory,orcountry.
Percentageofproductssoldtooutofstatecustomers:Enterthepercentageof
productsthataredistributedtoacustomerinanotherstate,territory,orcountry.
Percentageofproductssoldretail:Enterthepercentageofproductssolddirectlyto
theendconsumer(handtohand,Internetsales,farmersmarkets,etc.)
Percentageofproductssoldwholesale:Enterthepercentageofproductssoldto
wholesaleaccountsforthepurposeofresale(restaurants,retailstores,etc.)
ChecklistofRequiredInformation:Thissectionisintendedtohelpyoumakesurethat
youhaveincludedeverythinginyourpacketthatisrequired.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page2oftheApplication
ApplicationInstructions:Takecaretoreadandfollowthe
applicationinstructionsonPage2carefully,inadditionto
reviewingthisdocument’sguidance.Failuretofollowthe
applicationinstructionswillcomplicatethereviewprocess,
mayresultinareturnedapplication,adelayinapprovalof
yourapplication,oryourapplicationmaynotbeapproved.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page3oftheApplication
CommercialKitchenApproval
Contactthecommercialkitchenandinquireaboutwhether
youcanconductafoodbusinessintheirfacility.Iftheywill
allowit,askforwrittendocumentationconfirmingthis.Itcan
beintheformofletter,email,licenseorother.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page4oftheApplication
FoodProcessingandStorageAreaDiagram
Provideadiagram,hand‐drawnorcomputergenerated,ofall
theareasthatwillbeusedforpreparingfood,storingfood
andwashingandstoringequipment,packaging,orothernon‐
foodmaterials.Youmayalsosubmitpictures.
Allmaterialsusedforyourfoodbusinessmustbestoredat
thecommercialkitchen.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page5and6oftheApplication
EmployeeTrainingandRecords
Providedocumentationthatemployeetrainingwas
completed.Atemplateyoumayusetodocumentemployee
trainingisprovided.
Trainingmustbecompletedpriortosubmittingthe
application.Adequatetrainingwillcoverprinciplesoffood
hygieneandfoodsafety,asappropriatetoyourfood
processingoperationandthedutiesofeachemployee.
*Specialnoteforsingle‐employeebusinesses:Evenifthe
owneristheonlyemployee,atrainingrecordstillneedstobe
maintained.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page6oftheApplication
ProductListandPlannedDistribution
Intheleftcolumn,listthenameofeachofyourproducts.
Intherightcolumn,listtheoutletswhereyouintendon
sellingyourproductstotheconsumer.Examples:deliveryto
customerhomeorevent,FarmersMarket,grocerystores,
convenientstores,restaurants,overtheinternettobe
shippedviaUSPS,UPS,FedEx.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page7oftheApplication
PreventingAllergenCross‐Contact
Provideawrittenplanforpreventingallergencross‐contact.Reviewthe
Allergen Control Plan – Overview and Guidance”foranoutlineofthe
topicsyourplanshouldcover.Youshouldconductafoodallergen
ingredientanalysis,whichconsidersalleightmajorfoodallergens.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.A
templateisprovidedonpage8tohelpyouwithyourallergeningredient
analysis.
*Specialconsideration:Whenyouoperateinasharedspacethatisalso
usedbyotherbusinesses/individuals,youmustalsoconsidercross‐
contactfromingredients/foodsthatareusedbyother
businesses/individuals.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page8oftheApplication
CompletetheAllergenControlPlan– MasterListof
Ingredients
Listyouringredients(rawmaterials)inthecolumnontheleft.
Identifythesupplier/manufacturerofyouringredient.Allingredientsmust
comefromapprovedsources.Inthecaseofingredientssuchasherbs,fruits,
vegetables,ifyougrowtheseyourself,youmayusetheminyourbusiness.
Listtheingredientsfromthepackagelabeloftheingredient.Theseingredients
willbethe“sub‐ingredients”fortheingredientonyourownlabel.
Identifythefoodallergensineachingredientbymarkingifanyofthefollowing
arepresent:Egg,Milk,Soy,Wheat,TreeNut,Peanut,Fish,Shellfish.
Checkthepackaginglabelofyouringredientsforanyallergenprecautionary
labelinganddetermineifthisinformationshouldalsobeonyourownlabel.
Youmayneedtocontactthemanufacturerforclarificationoftheir
precautionarystatement.
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CompletingtheApplication
Page 9oftheApplication
RequirementsofSubpartsC&GandExemptions
Donotcompletethissectionifyourbusinessisanyofthefollowing:
Abusinessconductingatleast50%ofsalesdirectlytotheconsumer
(retail).ThistypeofbusinessdoesnotneedtoattesttoFDA.
Averysmallbusiness thathasattested.Averysmallbusinessisone
thataverageslessthan$1,000,000insalesofhumanfoodperyear
for3years.Evenifyouareasmallbusiness,youmuststillattestto
FDAusingtheQualifiedFacilityAttestationmodule:
https://www.access.fda.gov
Note:Ifyourbusinessmodelchanges(increasedsales,wholesale
greaterthan50%),thenyoumustcomplywithSubpartsC&G.
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CompletingtheApplication
Page 9oftheApplication
RequirementsofSubpartsC&GandExemptions(continued)
Donotcompletethissectionifyourbusinessisanyofthefollowing:
Devotedstrictlytomakingseafoodproductsunder21CFR123
Devotedstrictlytomaking100%juice under21CFR120.Youcannot
claimexemptionfromSubpartsC&Gifyoudonottreatyourjuice
witha5‐logreductioninpathogens
Devotedstrictlytomakingdietarysupplementsunder21CFR111
Devotedstrictlytomakingalcoholicbeverages
Ifyouaremakinganyoftheabove,PLUSotherproducts,thenyouare
subjecttoSubpartsC&Gandthereforemustsubmitdocumentation.
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CompletingtheApplication
Page9 oftheApplication
RequirementsofSubpartsC&GandExemptions(continued)
Ifyourbusinessdoesnotfitintothecategoriesontheprevioustwo
pages,thenyouarerequiredtocomplywithandsupply,withyour
application,writtendocumentation thatyouareaPreventiveControls
QualifiedIndividual andhavebothawrittenFoodSafetyPlananda
Supply‐ChainProgram.
Usetheresourcesprovidedintheapplicationtofindmoreinformation
ontherequirementsandguidanceonbuildingyourprograms.
VDACS-FSP-APPCK-GUIDE REV 07/22
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CompletingtheApplication
Page13oftheApplication
ProductInformationSheet
BusinessName:EnterthenameofyourBusiness
Date:Enterthedateyousubmittedthisrecipe
ProductName:Enterthenameoftheproductthisrecipeisfor
TradeSecret: Markthisboxifyourproductistradesecret/confidential.Please
notethatyoustillneedtoprovidetherequiredinformation.Markingthe
productastradesecretprotectsitfrombeingreleasedunderpublicFreedom
ofInformationActrequests.
Ingredients:Listeachingredientthatwillbeusedinyourrecipe.Listthe
amountofeachingredient,preferablyinweight,althoughcups,teaspoons,
gallons,etc.willsuffice.
Step‐By‐StepInstructions:(discussiononnextpage)
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CompletingtheApplication
Page13oftheApplication
ProductInformationSheet
Step‐By‐StepInstructions
Listeachstepintheprocessofmakingyourproduct.Includethingslike:
finalbaking/cookingtemperatureforproductslikecustarddesserts
(pumpkinpie,chocolatepudding,cheesecake)orrawmeats;cooling
methodsandtimes/temperaturesforitemslikecookedfoodthatwill
ultimatelybesoldrefrigerated;finalstorageinstructionsforitemsthat
arefrozenorrefrigerated;expirationdatesforproductsthatare
refrigeratedandready‐to‐eat.Seethenextpageforspecific
temperaturerequirements.
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TipsonTemperatures
Useacalibratedprobethermometertocheck:
CookingTemperatures
Rawseafood/meat—145°F
Rawegg,groundmeat/seafood—155°F
Stuffedproductsorrawpoultry—165°F
DateMarking
Itisrecommendedthatanyready‐to‐eat
food(dip/spread,soup,custard,salad,
etc.)thatyousellrefrigeratedshouldbe
markedtobeconsumedwithin7days
withthedayofpreparationcountedas
day1.IfyoumakeaproductonSunday,
theexpirationdatewouldbeSaturday.
Youmayalsoworkwithprocess
authoritytodetermineanappropriate
shelf‐lifeforyourproduct.Youshould
includetheexpirationdateonyour
label.
ColdStorageTemperature
Allfoodstoredunderrefrigerationmustbe
41°Forbelow.
Allfoodstoredfrozenmustremainsolidly
frozen.
Cooling
Anyfoodthatyouhaveheated,mustbe
cooledproperly.Youmustcoolthe
productrapidlyusinganicebath,ice
paddle,refrigerationunitwithgoodair
movement,orother.Thefoodmustcool
from135°Fto70°Fintwohoursandfrom
70°Fto41°Finfourhours.Createalog
thatyouwillusetomonitorthecooling
andsubmitthislogwiththeapplication.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 17 of 59
SampleCoolingLog
Start After2hours After4hours
Date FoodItem Time/Temp Time/Temp Time/Temp
11‐7 Blackbeansoup 10:00AM/155F 12:00PM/60F 4:00PM/33F
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 18 of 59
CompletingtheApplication
Page14oftheApplication
ProductLabel
You must provideacompleteandfinallabelforeach ofyourproducts.Labelingis
mandatoryforallpackagedfoods.
Reviewtheinstructionsonpages14and15oftheapplication.Theproductlabelingis
importantandwillbescrutinizedforaccuracybythereviewerofyourapplication.
VirginiaCooperativeExtension(VCE)hascreatedguidancedocumentsthatmighthelp,
too.Ifyouneedfurtherassistance,VCEmightbeabletohelpwithyourlabels.Youcan
accesstheirwebsite:https://ext.vt.edu/food‐health/food‐innovations.html orcall540‐
231‐2483.
Thechecklistusedbythereviewerofyourapplicationisincludedonthenextpage.Itis
beingprovidedforyourconvenience,sothatyoumaysubmitcorrectlabelsandthus,
expeditethereviewofyourapplication.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 19 of 59
StatementofIdentity
Iftwolabels,onfrontof
package
Describesfood
Paralleltobottomoflabel
Boldtext,prominent
NetContents
Iftwolabels,onfrontof
package
Locatedinlowerthirdoflabel
(bottom)
Paralleltobottomoflabel
Boldtext
Distinctitem(emptyspace
aroundstatement)
USCustomaryandMetricunits
Ifliquid,declaredinfluid
measure
Ifliquid,precededby“net”
Ifsolid,declaredbyweight
Ifsolid,precededby“netwt”
Ifeggs,declaredbycount
Ingredients
Matchesrecipe
Listedinorderofheaviesttoleast
heavy
Sub‐ingredientsinparenthesis
Nofancifulwords(fresh,artesian,local)
Text>1/16inch
Ifspiceblend,cannotlist“spices”as
ingredient
“and/or”onlyusedforfatoroil
Iftwolabels,onsameasname/place
andNFpanel
AllergenLabeling
Declarediningredientlistand/or
containsstatement
Ifcontainsstatement:
Onlyusetext“Contains:_,_,_”
Onlyuse:treenut(specific),fish
(specific),
crustaceanshellfish,p
eanut,
soy,
wheat,egg,
milk
ALLallergenslisted
Directlyafteringredientstatement
Sametypesizeasingredients
NameandPlaceofBusiness
Fullphysicaladdress
Iftwolabels,onsameasingredients
and
NFpanel
NutritionFactsLabel
Surroundedbybox
Ifnotusingstandardformat,use
appropria
teformatbasedo
nlabel
size
Iftwolabels,onsameas
name/placeandingredients
Ifstandardformat,allpresent
Claims
Ifnutrientcontentclaimorhealth
claim,NFpanelpresent
Nutrientcontentclaimmeets
definit
ion(AppendixAand
Bof
FDAguide)
Mustbetruthful,notmisleading
ORmeetFDAdefinition
Ifglutenfree,meetsdefinition
Ifhealthy,meetsdefinition(see
101.65(d)(2))
Ifnon‐GMO,truthful
IfAllNatural,truthful
Diseaseclaimnotallowed
Other
Notext,picture,symbolbetween
ingredie
nts,name/address,
NF
panel
Nospellingmistakesonrequired
information
Labeling
Requirements
Checklist
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 20 of 59
CorrectLabel
NetWt16oz(484g)
Sally’sSpicy
SerranoSauce
Hotsauce
Ingredients:vinegar,
serranopeppers,tomato
sauce(tomatopuree
(water,tomatopaste),
water,lessthan2%of:
salt,citricacid,onion
powder,garlicpowder,
redpepper),sugar,salt.
Sally’sSpicyLLC
12121E.MainStreet
Richmond,VA23181
We thisserrano
saucebecauseof
it’ssweetandfruity
kickbalancedwith
theperfectamount
ofacid.Enjoy!
Findourotherspicy
saucesat:
sallysspicy.com
Allstatementsmadeonthewebsiteare
consideredlabelingandmustalsobein
compliance.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 21 of 59
CorrectLabel
Frontlabel Back(orside)label
Sally’sSpicy
SerranoSauce
Hotsauce
NetWt16oz(484g)
We thisserranosaucebecauseofit’s
sweetandfruitykickbalancedwiththe
perfectamountofacid.Enjoy!
Ingredients:vinegar,serranopeppers,
tomatosauce(tomatopuree(water,
tomatopaste),water,lessthan2%of:salt,
citricacid,onionpowder,garlicpowder,red
pepper),sugar,salt.
Sally’sSpicyLLC
12121E.MainStreetRichmond,VA23181
Findourotherspicysaucesat:sallysspicy.com
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 22 of 59
CorrectLabel
Sally’sSpicy
SerranoSauce
Hotsauce
NetWt16oz(484g)
Ingredients:vinegar,serranopeppers,tomatosauce(tomatopuree(water,
tomatopaste),water,lessthan2%of:salt,citricacid,onionpowder,garlic
powder,redpepper),sugar,salt.
Sally’sSpicyLLC∙12121E.MainStreetRichmond,VA23181∙sallysspicy.com
Top
label
Sidelabel
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 23 of 59
IncorrectLabel
NetWt16oz
Sally’sSpicy
Ingredients:salt,serrano
peppers,tomatosauce
(tomatopuree(water,tomato
paste),water,lessthan2%of:
salt,citricacid,onionpowder,
garlicpowder,redpepper).
Findourotherspicysaucesat:
sallysspicy.com
Sally’sSpicyLLC
12121E.MainStreet
Richmond,VA23181
We this
healthy
serrano
saucebecauseof
it’ssweetand
fruitykick
balancedwith
theperfect
amountofacid.
Enjoy!
Ingredientsandnameandaddressof
businessnottotherightofprincipal
displaypanel.
Materialbetweeningredientsandnameand
addressofbusiness
Noproductidentity
Useofterm“healthy”notallowed
becauseproductdoesnotmeet
definitionofhealthy,andnonutrition
factspanelispresent.
Ingredientsarenotlistedinorderofheaviesttoleastheavyaccordingtotherecipe,i.e.,therecipe
isnotmadepredominantlyofsalt.Someingredientsfromrecipearemissing(vinegarandsugar).
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 24 of 59
CorrectLabel
WeightExample
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 25 of 59
CorrectLabel
FluidMeasureExample
ORANGEJUICE
Contains:100%Juice
Ingredients:FilteredWater,Orange
JuiceConcentrate.
ABCJuiceCompany
111CountryRoad
Anytown,VA12345
Perishable
KEEPREFRIGERATED
Net16floz(236mL)
Foodsthatrequirerefrigerationmustbe
clearlylabeled“KEEPREFRIGERATED.”
Frozenfoodproductsmustbeclearly
labeled“KEEPFROZEN.”
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 26 of 59
CorrectLabel
MulticomponentProductExample
APPLEPIE
Ingredients:Filling:Apples,Sugar,LemonJuice,Cinnamon.Crust:Flour
(bleachedwheatflour,maltedbarleyflour,niacin,iron,thiaminmononitrate,
riboflavin,folicacid),Butter (cream,salt),Egg,Salt.Contains:Wheat,Egg,
Milk.
VirginiaPiesLLC,123MainStreet,Anytown,VA12345
Netwt.34oz(964g)
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 27 of 59
IncorrectLabel
CHOCOLATECHIPSCOOKIES
Nt wt.10oz (484g)
Ingredients:all‐purposeflour,semi‐sweetchocolatechips,butter,walnuts,granulatedsugar,brown
sugar,eggs,sodiumbicarbonate,vanillaextract,salt.ALLERGYALERT:eggsandwalnuts
Grannie’sCookies∙Anytown,VA∙804‐111‐2222∙grannybakesathome.com∙[email protected]
Netweightcanonlybeabbreviatedas“Netwt”.
10ozisnotequivalentto484g.
Netweightstatementmustbeplacedatbottomoflabel
.
Subingredientsaremissingfor
flour,chocolatechips,and
vanillaextract.
Using“allergyalert”isincorrect.Allergensmustbedeclaredinthefollowingway:“Contains:X,X,X”.
Theallergenswheat,soyandmilkareomittedfromtheallergenstatement.
Thefullphysicaladdressisnot
included.Phonenumber,
website,email,etc.donot
substituteforfullphysical
address.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 28 of 59
ReviewofYourApplication
Oncesubmitted,yourapplicationwillbereviewed.The
reviewerwillcontactyoutoletyouknowthatyour
applicationhasbeenreceived.Expectthatthereviewcould
takeseveralweeks.Thereviewerwillcontactyouwiththeir
commentsandlistofitemsneededtocompletethereview.
Oncethereviewerhasdeterminedyourapplicationis
complete,theinspectorwillbenotifiedthatyouarereadyfor
inspection.Theinspectorwillcontactyoutoscheduleatime
theycanconducttheinspectionwithyouatthecommercial
kitchen.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 29 of 59
SpecialNoteforDietarySupplements
Adietarysupplementisaproductintendedforingestion that
containsaningredient(s)intendedtoaddfurthernutritionalvalue
to,orsupplement,thediet.Youmightbemakingadietary
supplementifyouareaddingcertainingredientsthatdon’thavea
historyofuseinfood,rathertheyhaveahistoryofhealingor
wellnessproperties.Youmightbemakingadietarysupplement
basedonlabelingstatementsordirectionsforuse.Youmightalso
bemakingadietarysupplementifyourproductisinapill,capsule,
dropper,powder,tabletorothersimilarform.
Ifyouaremakingadietarysupplement,youarerequiredtomeet
21CFR111.Yourapplicationwillnotberevieweduntilyouhaveall
thedietarysupplementpaperworkinorder.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 30 of 59
SpecialNoteforAcidifiedFoods
Ifyouaremakingacidifiedfoods,youwillneedtomeetthe
requirementsof21CFR114.Youwillberequiredtohaveyour
producttestedbywhatiscalledaprocessauthorityand
createandmaintainrecords.Youcanfindaprocessauthority
atthiswebsite:https://www.afdo.org/directories/fpa/oryou
maycontacttheprocessauthorityinVirginia,Joell Eifert,
DirectorofVT’sFoodInnovationProgram.Shecanbereached
byemail([email protected])orphone540‐231‐5770.
Yourapplicationwillnotberevieweduntilyouhaveallthe
acidifiedfoodpaperworkinorder.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 31 of 59
WhatisanAcidifiedFood?
Itisshelf‐stable,usuallypackagedinaglassjar
Itisafoodthathasalowacidcontent,butyouaddafoodwithahighacid
contenttomaketheendproducthaveahighacidcontent,thustheterm
“acidified”
ItisafoodthathasafinalpHof4.6orless
Someexamplesarepickles,figjam,gingerjam,mangojam,pumpkinbutter,
pepperjelly,pickledvegetables,salsa,andrelish.
Whatalloftheseproductshaveincommonisthatthemainingredient(fig,
pumpkin,peppers,beets,tomato/onion,pickle)havealowacidcontent,but
whenyouaddingredients(lemon/limejuice,citricacid,orvinegar)thathavea
highacidcontent,itresultsinaproductthathasahighacidcontent(below4.6
pH).
Thereareadditionalrequirementsforacidifiedfoodmanufacturers.These
requirementsareincludedonthenextpage.Theyarebeingprovidedforyour
informationsothatyoumaysubmitalloftherequireddocumentationtogether,and
thusexpeditethereviewofyourapplication.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 32 of 59
Better Process Control
School
Successfully c
omplete
course
Provide copy of certificate
Process Authority Evaluation
Each Acidified Food product
must
be evaluated by a
competent Process Authority
Filing with FDA
Register as a Food
Canning
Establishment
Form
FDA 2541
File each separate product
Form FDA 2541e
FDA Establishment
Registration and Process
Filing
Process Authority Report
Specific to each acidified
food
product
Contains all of the following:
Container type
Container size
pH of product before acidification
pH after acidification
Time to achieve equilibrium pH
Method of acidification
Acidifying agent
Microbial preservative (if
applicable)
Process mode
Container and closure treatment
method
Minimum initial temperature or fill
temperature
Process time
Process temperature (for hot
fill/hold methods)
F value
Least sterilizing value
Maximum fill weight (if
applicable)
Product Information Sheet
Recipe matches
scheduled
process
in Process
Authority
report
Includes critical limits described in
schedule
process
Record Templates
Examinations of raw m
aterials,
packaging
materials, and
finished
products
Processing and production records
Document adherence to
Scheduled Process
pH measurements and other
critical factors
Product, lot code, date,
container size
Corrective action records
Initial distribution of
finished
products
Maintained for 3
years
Recall
Procedures
Plans for recalling products
that
may be injurious to health
AcidifiedFoods– AdditionalRequirements
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 33 of 59
SpecialNotefor100%JuiceProducts
Ifyouaremakingabeveragethatis100%fruitorvegetable
juice,youwillneedtomeettherequirementsofJuiceHACCP,
21CFR120.YouwillberequiredtobecomeaHACCPtrained
individual,createandmaintainahazardanalysisandHACCP
plansforyourproductsandcreateandmaintainrecords.If
youneedhelpwithanyofthis,youmayreachouttoJoell
Eifert,DirectorofVT’sFoodInnovationProgram.Shecanbe
reachedbyemail([email protected])orphone540‐231‐5770.
Yourapplicationwillnotberevieweduntilyouhaveallthe
juiceHACCPpaperworkinorder.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 34 of 59
SpecialNoteforSeafoodContainingProducts
Ifyouaremakingproductsthatcontainseafood(clam
chowder,oystersRockefeller,crabcakes,crabdip,smoked
fish,etc.)youwillbeneedtomeettherequirementsof
SeafoodHACCP,21CFR123.Youwillberequiredtobecomea
HACCPtrainedindividual,createandmaintainHACCPplans
foryourproductsandcreateandmaintainrecords.Ifyou
needhelpwithanyofthis,youmayreachouttoDr.Michael
Schwarz,DirectorofVT’sseafoodextensioncenter.Hecanbe
reachedbyemail([email protected])orphone757‐727‐
4861.
Yourapplicationwillnotberevieweduntilyouhaveallthe
seafoodHACCPpaperworkinorder.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 35 of 59
SpecialNoteforMeatContainingProducts
Youmayusemeatandpoultryingredientsinyourproducts,
butonlyiftheproductsaresolddirectlytotheenduser,such
asatafarmer’smarket.
Ifyouwishtosellyourmeatorpoultrycontainingproducts
wholesale(tootherbusinesseslikerestaurants,convenient
storesorgrocerystores),thenyouwouldneedtocontact
VDACSOfficeofMeatandPoultryServicesat804‐786‐4569.
Themeatandpoultryyouuseforyourproductsmustbe
stampedwiththeUSDAmarkofinspection.Meatgroundat
thegrocerystorewillnotcarrythismark,soitmaynotbe
used.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 36 of 59
SpecialNoteforProductsContainingAlcohol
Ifyouaremakingaproductthathasalcoholasaningredient(flavorings
likevanillaextractnotincluded),youmusthaveitevaluatedto
determinehowmuchalcoholispresentisinthefinalproduct.Ifyour
productisdeterminedtohavegreaterthan0.5%alcoholbyvolume,you
cannotmakeandsellthisproduct.Ifitisless,youcanproduceit,but
youmustcontactyourlocalAlcoholBeverageCommission(ABC)office
toinquireaboutpermitsorlicenses.
Tohaveyourproducttested,youmaycontactKenHurley,Directorof
EnologyAnalyticalServicesLaboratoryatVirginiaTech.Hecanbe
reachedbyemail([email protected])orphone540‐231‐7447.
Recipesthatcontainalcoholmustbeaccompaniedbythetestingresults
showingtheproductcontainslessthan0.5%alcoholbyvolume.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 37 of 59
SpecialNoteforProductsDairyorFrozenDesserts
IfyouwanttomakegradeAdairyproductslikepasteurized
milk,yogurt,cottagecheese,andsourcreamthenyoumust
obtainapermitfromVirginiaDepartmentofHealth.VDACS
FoodSafetyProgram
willnotbeinvolvedinthisinspection.
Ifyouwanttomakemanufactureddairyproducts
like
cheeseorbutterorifyouwanttomakefrozendessertslike
icecream,contactVDACSDairyServicesat804‐786‐1452.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 38 of 59
SpecialNoteonCatering
Cateringoperationsareregulatedthroughthelocalhealth
departments.VDACSdoesnotinspectorhavejurisdiction
overanybusinessesthatcater.Asacommercialkitchenfood
processingbusiness,youareconsideredamanufacturer.Your
VDACSinspectionallowsyoutomakefoodproductsatthe
commercialkitchen,packageandlabelthem,andsellthem
eitherdirectlytotheendconsumer(overtheinternet,
farmer’smarket,festival,etc.)orsellyourproductstoother
businesses.
CateringfallsundertheVirginiaDepartmentofHealthand
youmustcontactthemtoobtainaseparatepermittocater.
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 39 of 59
ItemsNeeded:Thermometers
Anambientairthermometer intherefrigerator.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 40 of 59
0°Fto220°F.Thisisnecessarytotaketheinternal
temperatureoffoodproducts.
Thisisnecessarytomonitortheairtemperatureofthe
refrigerator.Youwanttheairtemperatureofthe
refrigeratortobeabout38°Finordertokeepfoods
41°Forbelow.
Ametalstemprobetypethermometerthatreadsfrom
InternalFoodTemperatures
ColdHolding(inrefrigerator)– 41°F
orlower
HotHolding– 135°Forhigher
FrozenFoods‐ 32°Forlower
Cooking(seafood,meat)– 145°For
higher
Cooking(raweggs,groundmeator
seafood)– 155°Forhigher
Cooking(poultry,stuffedfoods)–
165°Forhigher
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 41 of 59
ItemsNeeded:HairRestraints,CleanClothing,
DisposableGloves
Properhairrestraintsarerequiredtobewornwhile
processing.Thesecaninclude:
BallCap(allhairmustbecoveredbythecap)
HairNet(recommended)
BeardGuard
Makesurethatyouwearcleanclothing/aprons,etc.while
processing.
Disposablegloveuseisalsorequiredwhenyouarehandling
finished,ready‐to‐eatfoodproducts.Thiswillreducethe
chanceofcontaminationfromyourhandstoyourproducts.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 42 of 59
ItemsNeededtoCleanHands
DesignatedHandWashSink usethissinktowashyour
handsinwaterabove100°Fwithsoapfor20seconds.The
sinkmustalsobeprovidedwithsingle‐usetowelsorother.
Note:Washingyourhandsinthesinkwhereyouclean
equipmentisnotallowed.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 43 of 59
ItemsNeededtoCleanHands
HandwashingSinkprovidedwith:
1. Soap
2. PaperTowels
3. TrashCan
4. Hot(100°Fminimum)andcoldrunningwaterondemand
5. Handwash Sign
Note:Donotuseclothtowelsfordryingyourhands.Theycan
holdmoistureandgerms.Handdryingtowelsmustbesingle
useanddisposedofaftereachuse.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 44 of 59
ItemsNeededtoCleanHands
Asignorposterthatnotifiesfoodemployeestowashtheirhandsshallbeprovidedat
allhandwashingsinksandshallbeclearlyvisible.
Howtowashyourhands:
1. Wethandswithhotrunningwater
2. ApplySoap
3. Rubhandsfor20‐30seconds
4. Cleanunderfingernailsandbetweenfingers
5. Rinsehandsthoroughlyunderrunningwater
6. Dryhands
Youcanobtainapre‐madehandwashsignfromarestaurantsupplycompany.Your
inspectormayalsohaveasignthattheycanleavewithyouatthetimeofyour
commercialkitcheninspection.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 45 of 59
ItemsNeededtoCleanEquipment
Warewashingsink soiledutensilsshallbewashed,rinsed
andsanitizedbeforeuse,witheachstepbeingperformedin
oneofthebasins.Additionally,thissinkshallbedesignated
onlyforutensil/equipmentcleaning.
PreparingfortheInspection
WarewashingSinkmustbeprovidedwith:
1. Detergent
2. Hot(110°Fminimum)andcoldrunningwaterondemand
3. Sanitizer(moreinformationonnextslide)
4.
SanitizerTestStrips
5. SinkStoppers
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 46 of 59
ItemsNeededtoCleanEquipment:Sanitizer
Youwillneedtopurchaseachemicalsanitizer.Twoofthemostcommonly
usedchemicalsanitizersare:
Chlorine(Bleach) Thisisthesametypeofbleachthatyoucanbuyat
yourlocalgroceryorsupermarket.
PROS– easytofindandinexpensive
CONS– strongodorandcausesbleachingofclothes
Tips:lookforunscented,not splash‐less,not concentrated
AmmoniaBasedSanitizer(QuaternaryAmmoniumChloride“QUATS”)
Thisistypicallyfoundatanyrestaurantsupplycompanyoronline.
PROS– mildodor,availableintabletformforeasymeasuring
CONS– notaseasilyobtainedasbleach,slightlymoreexpensivethan
bleach
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 47 of 59
ItemsNeededtoCleanEquipment:SanitizerTestStrips
Youwillneedtopurchasesanitizerteststrips.
Thesestripsareusedtotesttheconcentration ofthesanitizersolutionthat
youuseafterwashingdishes.
Chlorineshouldbeusedinroomtemperaturewaterat50ppm
Quat shouldbeusedasdirectedoncontainer,butusually200ppm
Sanitizerteststripsarespecific tothetypeofsanitizerthatyouchoose.In
otherwords,sanitizerteststripsforchlorinewillnot workwiththeammonia
based“QUATS”sanitizerandviceversa.
Quat strips Chlorinestrips
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 48 of 59
HowtoCleanSoiledEquipment
Pre‐cleanbyscrapinglargefoodparticlesintotrashcan
Washinhotsoapywater
Rinsesoapfromsurfaceincleanwater
Submergeequipmentinchemicalsanitizerforatleast60
seconds
Airdry– Donottoweldry
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 49 of 59
IncomingWaterSupply:PublicorPrivateSourced
Ifyouareusingwaterfromapublic municipalsource,thenyouwillnot
needanydocumentationonwateranalysis.However,ifyouareusinga
privatesourceofwater,suchasawellorspring,thenyouwillneedto
havethewatertestedannuallyforcoliform*bacteriatoshowthatyour
waterissafeforconsumption,safetobeusedtocleanyourdishes,and
safeforproperhandwashing.Keeprecordsofyourwatertestingreports
toshowtotheinspectoruponrequest.
*Thepresenceofcoliformbacteriaindrinkingwaterindicatesthat
disease‐causing organisms (pathogens)couldbeinthewatersystem.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 50 of 59
StoringYourFoodProductsandEquipment/Utensils
Allfoodproducts(packagedandnon‐packaged)mustbestoredatleast4‐6inches
abovethefloorlevel.
Youmaystore
foodproductsandequipment/utensilsincabinets,o
nshelving,
pallets,
tables,etc.aslongastheyarecleanandwon’tdirtythefood
or
equipment/utensil
Foodproducts,supplies,equipment,andutensilsmustbestoredinamannerthat
prevents
themfrombeingcontaminated.Thiscanbeaccomplished
bystoringthese
items
covered,inverted,andbymaintainingyourcommercialkitchenspacei
na
conditionthat
ensuresinsect/rodententrypointssuchasdoors
,windows,floors,
walls,
ceiling,andtheroofareinproperworkingorder/condition.
Ifyouuserawfoods(eggs,meat,etc.)inyourfoodproducts,storetheminthe
refrigeratorBELOW anyotherready‐to‐eat
foodproducts.Thiswillhelppreventan
y
potential
leakageontootheritemss
toredintherefrigerator.
PreparingfortheInspection
VDACS-FSP-APPCK-GUIDE REV 07/22
Page 51 of 59
StoringYourFoodProductsandEquipment/Utensils
Alldrygoods,refrigeratedfoodproducts,equipment/utensils,packagingmaterial,
finishedproducts,etc.thatareassociatedforyourbusinessmustbestoredatthe
commercialkitchen.
PreparingfortheInspection
Itisimportanttomakesurethatallchemicalsarestoredawayfromyourfood
products,equipment,andutensils.Findanareatosegregateyourchemicals(to
includeyoursanitizer,medicines,firstaidsupplies,etc.)sothatyoucanprevent
potentialcontamination.
StoringChemicals
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Kitchen/ProcessingAreaLighting
Lightinginthekitchenthatisaboveandaroundyourfoodprocessingareasand
unpackagedfoodproductsMUST haveprotectiveshieldssuchasplastictubing
withendcaps(forfluorescentceilinglighting),anotherformofacover,orthelight
bulbsmustbeshatterproof.Thispreventsglassfromyourproductifbreakage
weretohappen.
PreparingfortheInspection
Kitchen/ProcessingAreaFoodPreparationArea
Allfloors,walls,andceilingsinthefoodpreparationarea(s)mustbe:madeofa
materialthatissmooth,easilycleanable,andnon‐absorbentandfreefromopen
cracks,holes,exposedinsulation,andflaking/peelingpaint.Thismeansno
carpeting,noexposed,andnounsealedwood.Wallsmustbepaintedinaglossy
paintorothersmoothcleanablesurface.Surfacesthatcannotbeeasilycleaned
andsanitizedcontributetoadirtyworkareaandcouldcontaminateyourproduct.
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DevelopingaLotCodeSystem
Somebusinessesfindthatassigninglotcodestotheirfinishedproductshelpsthemto
tracktheirfoodproductsthattheydistributetootherbusinesses.Thissystemwouldbe
verybeneficialincaseyoufinditnecessarytorecallcertainproductsyouhave
manufactured.Withoutalotcodingsystem,youmayhavetorecallallyourproductifitis
knowntohavebeencontaminatedorpotentiallyharmfultothepublic.Belowisan
exampleofasimplelotcodesystemorlog:
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TheDayofYourInspection
Onceyourbusinessapplicationhasbeenapproved,itisforwardedtotheinspector
thatworksinthatarea.Theinspectorwillcontactyoutoconfirmadateandtimethat
theycanmeetyoufortheinitialinspection.Theinspectionshouldnottakelongerthan
about1‐2hours.
*Specialnoteforfutureinspections: Routineinspectionsareunannouncedand
unscheduled.Theinspectorwillvisitforinspectionduringthehoursofoperationyou
providedinyourapplication.
InmostcasesyouwillNOTbeaskedtomakeyourfoodproductsduringtheinspection
process.Iftheinspectorneedstowatchyoumakeafoodproduct,thentheywill
informyouofthatPRIORtomeetingwithyou.
Insomecasesyouwillbeaskedtoprovideasampleforlaboratoryanalysis.Please
makesurethatyouhavethissamplereadyatthetimeoftheinspection.Pleasedo
NOTwaituntiltheinspectorarrivestomaketheproduct.Thefoodproductcanbe
preparedatthecommercialkitchenthedaybeforeorearlier.Asamplesizeofatleast
onepoundwillsuffice.Prepareandpackagetheproductasyouwouldforsaletothe
customer.Thissamplewillbedepositedinasamplecollectionbagandshipping
containerthattheinspectorwillbringwiththemtotheinspection.
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ParticipatinginSpecialEvents
Onceyouroperationhasbeeninspected,yourinspectorwillleaveaninspectionreportand
Permit with you.Manyspecialeventswillrequirethatyoupresentthis permit tothemsothat
theycanverifythatyouareunderinspection.Thingstonoteaboutspecialevents:
1. Ifyouareplanningtooffersamplesatanevent,prepareALL ofyoursamplesinyour
inspectedcommercialkitchen.Thatiswhereyouareapprovedtoprocessfoods.Youarenot
allowedtomake/cut/slice/prepareetc.foodproductsatthespecialeventunlessyouhavea
portablehandwashsinkandthreecompartmentequipmentsink.
2. Makesurethatallfoodsareheldattheappropriatetemperatureswhileattheevent.
3. CarryacopyofyourPermitwithyoutoanyspecialeventyouattend.Many eventsareunder
thejurisdictionoflocalhealthdepartmentsandtheydoNOThaveaccess totheVDACS
database.PresentingyourPermittothehealthdepartment inspectorshouldbesatisfactory.
Thiswillofferproofthatyourfoodproductsarecoming fromanapprovedfoodsource(i.e.
thatyouareunderinspectionbyaregulatoryauthority).
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GuidelinesforProvidingSafeFoodSamplesattheMarket
SafepreparationUsecleansurfacesandutensils,goodpersonalhygiene,andproperstorageforpreparedsamples.
Wheneverpossible,preparethesamplespriortoarrivalatthemarket,sinceaccesstohandwashingandutensil
washingatthemarketmaybelimited.Ifyoumustpreparesamplesatthemarket,workonacleansurface,with
cleanutensilsandmakesuretowearglovesoncleanhands.Washfruitsandvegetablesincleanwaterpriorto
cutting,andoncewashed,storethemsotheydonotbecomesoiled.
KeepyourhandscleanHandsmustbewashedaftersmoking,eating,drinking,usingtherestroom,oranyother
timecontaminationoccurs.Remembertowashyourhandsfrequentlyandalwaysbeforeputtingongloves.Useof
handsanitizerdoesnottaketheplaceofwashingyourhandswithwarmsoapywater.Youcansetupasimple
handwashingstationwithawaterdispenser,catchbasin,soapanddisposablepapertowels.
BarrierbetweenhandandfoodTongs,spoons,single‐usedelipaper,plasticramekins,toothpicksordisposable
glovesareafewexamplesofgoodtools.Bringextrawithyoutothemarketsoyoudonotrunout.Remember:
glovesmustbeplacedoncleanhandsandchangedoften,andtheydonotsubstituteforproperhandwashing.
Keepequipmentclean Itisimportantthatanyknives,tongs,bowls,etc.thatyouuseforyourfoodsamplesiskept
clean.Youcanmakesuretheystaycleanifyoufollowathreestepprocessof:washinhotsoapywater,rinsein
cleanwater,anda2minutesoakinamildbleach‐watersolution,afterwards,lettingtheutensilair‐dry.Bleach
shouldbeaddedataratioofabout1teaspoonpergallonofwater,whichequatestoabout50ppm.Thiscanbe
measuredusingchlorineteststrips.Setthiswashingstationupinthreesmallplastictubs.
LimitationofexposuretimeIfyoursamplerequiresrefrigeration,limititsexposuretooutsidetemperaturesto4
hoursorless.Afterthe4hoursisup,discardanyuneatenfoodsamples.Keepextrasamplescoldinacoolerwithice
packs.
ProtectionfromtheenvironmentYoumustprotectthesamplesfromtheelements,pests(insectorbirds)anddirty
fingers.Displaysamplesundercoveringlikeadomeorplasticwrap.Topreventcustomersfromtouchingsamples
otherthantheirown,placeindividualsamplesinsingle‐servingcontainersorprovidetoothpicks.
ProtectallergiccustomersHavesignsorothermaterialsthatalertcustomersofthe8majorallergensthatmightbe
presentinyourproducts:milk,eggs,crustaceanshellfish,finfish,treenuts,wheat,peanuts,andsoybeans.Youdo
notwanttounintentionallycausesomeonetohaveanallergicreactiontoyourfood.
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ThingsToKeepinMind
Youwillbeapprovedtomakethefoodproductsthatwereincludedinyour
originalhome‐basedkitchenbusinessapplicationONLY.
Tomakenewrecipes,thoserecipesandlabelsMUSTbesubmittedto
VDACSPRIOR tomakingandofferingthosenewfoodproductsforpublic
sale.Thisincludesrecipesforsimilartypesoffoodproductsthatyouare
alreadymakingANDforanynewtypesoffoodproducts.
Newproductsmaybesubmittedforreviewatanytimeafteryourfirst
inspectionbysendinganewProductInformationSheetandlabelto
Ifyoumoveyourprocessingspacetoanewlocation,youneedtocontact
VDACSsothataninspectioncanbeconductedinthenewlocationPRIOR to
anyfoodproductsbeingmadeinthatnewlocation.Anewapplicationmust
besubmittedforthatnewlocation.Alsonotethatyourfoodproductlabels
willalsoneedtochangesothattheyreflectthenewaddress.
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Questions?
Call804‐786‐3520
or
email
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