COMPLIANCE AND ENFORCEMENT STRATEGIES
COMPLIANCE ANDENFORCEMENTSTRATEGIESVersion 1.0North CarolinaFood Protection Program
Table of ContentsSection 1: Purpose and Definitions . 1Section 2: FDA Risk Factors and Interventions . 2Section 3: Key of NC Violation Codes for FDA Risk Factors and Interventions. 3Section 4: Corrective Action/Corrected During Inspection, Verification, Enforcement Action P and PfCitations. 5Section 5: Compliance Tools . 29Section 6: Legal Remedies . 31Section 7: Emergency Situations . 38Section 8: Links. 41
SECTION 1: PURPOSE AND DEFINITIONSThis manual is intended to provide guidance and assistance with the compliance and enforcement ofNorth Carolina statutes and rules pertaining to Risk Factors and Interventions at regulated retail foodand drink establishments. Compliance and enforcement encompasses all voluntary and regulatoryactions taken to achieve compliance with regulations. Compliance and enforcement activities result intimely correction of code violations. This manual is not intended to replace the current laws and rules.For further clarification on any issue addressed within this manual, refer to the applicable statutes andrules. This manual is not intended to encompass all corrective actions possible for any givenscenario OR to replace the marking instructions and/or best professional judgement. If you areunsure about a corrective action you would like to enforce, reach out to your Regional Specialist.The regulatory authority for inspections is from the NC General Statute, NC Rules Governing FoodEstablishments, and NC Food Code Manual. HYPERLINKED PAGES take you to websites.The following acronyms will be used throughout this document:AMC – Active Managerial ControlCDI – Corrected During InspectionCIP – Cleaned in PlaceEHS – Environmental Health SpecialistHACCP – Hazard Analysis Critical Control PointHSP – Highly Susceptible PopulationP – Priority ViolationPF – Priority Foundation ViolationPHF – Potentially Hazardous Foods*PIC – Person in ChargeRCP – Risk Control PlanRTE – Ready to EatSOP – Standard Operating ProcedureTCS – Time/Temperature Control for SafetyTPHC – Time as a Public Health Control*TCS is the most up to date term for foods thatrequire time or temperature control for safety,however, PHF is still in the current Food Code used inNC and the General Statutes. For this reason, it isused throughout this document.1
SECTION 2: FDA RISK FACTORS ANDINTERVENTIONSEpidemiological outbreak data repeatedly identifies five major risk factors related to employeebehaviors and preparation practices in retail and food service establishments as contributing tofoodborne illness.Risk Factors Food from Unsafe Source Poor Personal Hygiene Inadequate Cooking Improper Holding/Time and Temperature Contaminated Equipment/Protection from ContaminationThe Food Code addresses controls for risk factors and further establishes five key public healthinterventions to protect consumer health. Specifically, these interventions are:Interventions Demonstration of Knowledge by Person in Charge (PIC)Implementation of Employee Health PoliciesBare Hand ContactTime/Temperature RelationshipsConsumer Advisory2
SECTION 3: KEY OF NC VIOLATION CODES FOR FDA RISKFACTORS AND INTERVENTIONSThe following key shows each Risk Factor and Intervention with the item number on the inspectionsheet and each relevant violation code. Colors are coordinated with the number of the grade sheet.2009RISK FACTORSItem #Unsafe SourceItem #3-201.11 P,PfPoorPersonalHygiene2-401.11 C43-201.12 P3-201.13 P93-301.12 P52-401.12 C173-401.11P,Pf183-501.14 P3-401.12 C19203-501.16(A)(1) P3-403.11 PItem #3-302.11 P133-501.16(A)(2) and(B) P3-304.11 P3-304.15(A) P3-306.13(A) P3-201.15 P2-301.12 P4-501.111 P2-301.14 P4-501.112 Pf3-201.17 P2-301.15 Pf4-501.113 C3-202.13 P2-301.16 Pf3-202.14 P5-202.12 Pf4-501.115 C3-202.110 P,Pf5-203.11 Pf4-601.11(A) P5-204.11 Pf4-602.11 P3-202.11 P,Pf5-205.11 Pf4-602.12 C3-101.11 P6-301.11 Pf4-702.11 P3-202.15 Pf6-301.12 Pf4-703.11 P3-202.18 Pf6-301.13 C3-203.12 Pf3-402.11 P6-301.14 C681415253-402.12 Pf24ContaminatedFood ContactSurfaces &Equipment2-301.11 P5-101.13 P1216Item #Improper HoldingTemperatures Hot& Cold, Rapidcooling3-201.14 P3-201.16 P1011Item #InadequateCooking4-501.114 P3-306.14 P3-701.11 C3-202.12 P3-302.14 P3-801.11 (A)(2), (A)(3)(B),(C ), (E) P7-101.11 Pf7-102.11 Pf7-201.11 P7-202.11 Pf7-202.12 P,Pf267-203.11 P7-204.11 P7-204.12 (A) P7-204.13 P7-204.14 P7-205.11 P7-206.11 P7-206.12 P7-206.13 (A) P7-207.12 P7-208.11Violation Codes (C) are "Core"Violations. Only P and Pf items areconsidered for enforcement.7-209.11 CP,Pf7-301.11 P3
2009INTERVENTIONSItem #2122Time/TemperatureParametersnot Met(Time as aControl, datemarking)3-501.17 Pf3-501.18 PItem #7Bare HandContactwithReady-toEat Food3-301.11 P,Pf3-801.11(D) PConsumerAdvisoryItem #(whenrequired)23Item #Demonstrationof Knowledgeby PIC2-101.11 Pf3-603.11 Pf13-501.19 P,Pf2-102.11 PfItem #22-102.12 C2-103.11 (A) -(L) Pf3-404.11 P,Pf273Employee HealthControl system orpolicy implemented2-103.11(M) Pf2-201.11 (A), (B), (C) &(E)P2-201.11 (D) and (F) P2-201.12 P2-201.13 P3-502.11 Pf3-502.12 P,Pf4-204.110(B) P,Pf8-103.12 P,Pf8-201.13 C8-201.14 PfViolation Codes (C) "Core"Violations. Only P and Pfitems are considered forenforcement.4
SECTION 4: CORRECTIVE ACTION/CORRECTEDDURING INSPECTION, VERIFICATION, ENFORCEMENTACTION P AND Pf CITATIONSThe chart below is a guidance document that provides acceptable options of short and long-termCorrective Action-Corrected During Inspection, Verification, Enforcement Actions for non-compliantFDA Risk Factors and Interventions. This chart links the NC Food Code reference to the inspectionform item number, then to the Corrective Action-Corrected During Inspection, Verification,Enforcement Action. The Corrective Action-Corrected During Inspection, Verification, EnforcementAction is chosen based on the severity and recurring nature of the violation. Long term complianceoptions address the continuing control of Risk Factors and Interventions.RISK FACTORS AND PUBLIC HEALTH INTERVENTIONSFood Code No.Foodborne Illness RiskFactors and PublicHealth Interventions1Intervention:Demonstration ofKnowledge by Person inCharge (PIC)Supervision:PIC present, DemonstrationCertification by accreditedprogram, and performsduties.Corrective ActionCorrected DuringInspection, Verification,Enforcement Action2-101.11(A)(B)- PICisCorrectedDuringdesignated.Inspection, Verification,Enforcement Action2-102.11 - PIC is enrolled inan ANSI-accredited course.2-103.11(A)-(L) - PICworked with REHS toregain active managerialcontrol (AMC)Intervention for Interventionfor Intervention for Longterm Compliance2-101.11 - Additional PIC isdesignated and trained to fillthe role when one is absent.2-102.11 - PIC is re-enrolled inan ANSI-accredited course asneeded to maintain credential.2-103.11(A)-(L) - PIC receivesadditional training. Areplacement PIC is chosen.5
Food Code dborne Illness RiskFactors and PublicHealth Interventions2Intervention:Implementation ofEmployee Health PoliciesEmployee Health:Management and foodemployee/conditionalemployee knowledgeresponsibilities andreporting.Corrective ActionCorrected DuringInspection, Verification,Enforcement Action2-103.11(M)- Inspection, Verification,foodEnforcementemployees. ActionMethods include: Postingpolicy in employee areas,mailing/emailing policy toemployees, schedulingeducational meetings withemployees, etc. EHS providesan approved health policy toPIC if facility does not haveone.2-201.11(A)(B)(C)(E) Employees are instructed onwhen and how to report. EHSprovides an approved healthpolicy to serve until PICcreates their own.Intervention for Interventionfor Intervention for Longterm Compliance2-103.11(M) - PIC receivesadditional training andinstruction. Approved healthpolicy is made available to PIC.2-201.11(A)(B)(C)(E) - Trainnew and existing employees toreport. Provide health policy toemployees through effectivemethods. EHS provides PICwith educational material onrequirements to aid indevelopment/update of healthpolicy.Employee Health Policy6
Food Code Reference2-201.11(D)(F)ItemNo.Foodborne Illness RiskFactors and PublicHealth Interventions3Intervention:Implementation ofEmployee Health Policies2-201.12(A)-(I)Corrective ActionCorrected DuringInspection, Verification,Enforcement Action2-201.11(D)- tion, Verification,Complywith exclusionandEnforcementActionrestriction specifications.2-201.13(A)-(I)Employee Health:Proper use of reporting,restriction and exclusion.2-201.12(A)-(I) - Exclude orrestrict employee based onspecific symptoms, diagnosis,and exposures. Exclude orrestrict employee ifreinstatement requirementsare not met.2-201.13(A)-(I) - Comply withconditions of removing,adjusting, and continuingexclusion.Intervention for Long-termCompliance2-201.11(D)(F) - PIC trained onexclusion and restrictionpolicy.2-201.12(A)-(I) - PIC trainedto recognize specificsymptoms, diagnosis, andexposures that requireexclusion and restriction ofemployees. PIC trained onreinstatement requirements.2-201.13(A)-(I) - PIC trainedto adhere to conditions.Job Aids to provide to PIC2009 Food Code EmployeeHealth policy with flowcharts: Employee HealthDecision Flow Charts3-301.124Risk Factor:Poor Personal HygieneGood Hygienic Practices:Proper eating, tasting,drinking, or tobacco use.2013 Food Code EmployeeHealth policy with flowcharts: Employee HealthDecision Flow Charts3-301.12 - Discard utensil ifsingle-use. Clean and sanitizeutensil if multi-use. Discardportion of foodcontaminated by foodemployee.3-301.12 - Train employeeson risk involved incontaminating food that is tobe sold or served. Trainemployees on proper methodof taste testing food.7
Food Code 1.152-301.16(A)(B)(C)ItemNo.6Foodborne Illness RiskFactors and PublicHealth InterventionsCorrective ActionCorrected DuringInspection, Verification,Enforcement ActionIntervention for Long-termComplianceRisk Factor:Poor Personal Hygiene2-301.11 - Employee washeshands and exposed portionsof arms.2-301.11 - Train employees onhow often to wash hands andexposed portions of arms.Preventing Contaminationby Hands:2-301.12(A)(B) - Employeecleans hands, exposedportions of arms, includingsurrogate prosthetic devicesfor hands or arms withcleaning compound, for atleast 20 seconds at properlyinstalled and equippedhandwashing sink.2-301.12(A)(B) - Trainemployees on how to cleanhands. Post instructionalhandwashing material athandwashing sinks.Hands clean and properlywashed.2-301.14 (A)-(I) - Employeewashes hands and exposedportions of arms.2-301.15 - Employee washeshands and exposed portionsof arms in a handwashingsink. If hands were washed infood preparation orwarewashing sink, that sink iscleaned and sanitized prior touse.2-301.14(A)-(I) - Trainemployees on when to washhands and exposed portions ofarms. Post instructional handcontamination material inemployee areas.2-301.15 - Train employees onwhere to wash hands. Postsigns that designatehandwashing sinks.2-301.16(A)(B)(C) - Reviewspecifications on handantiseptics used in the facility.Remove unapproved handantiseptics from facility.Change to different type ofhand antiseptic. Trainemployees on how to use handantiseptics. Post instructionalhand antiseptic use material athandwashing sinks.2-301.16(A)(B)(C) - If handantiseptic used was notcompliant for use in thefacility, employee rinseshands to remove theunapproved hand antisepticand removes non-complianthand antiseptic from facility.If hand antiseptic used wasHandwashing Proceduresnot compliant for hands thatHandwash Signdirectly contact food,employee rinses hands inclean water or limits activityto no direct bare handcontact with food. If hand dipsolution is not clean or tooweak, it is discarded.8
Food Code e Illness RiskFactors and PublicHealth InterventionsIntervention:Bare Hand ContactPreventing Contaminationby Hands:No bare hand contact withRTE foods or a preapproved alternate (B)5-205.116-301.116-301.12(A)(B)(C)(D)8Risk Factor:Poor Personal HygienePreventing Contaminationby Hands:Handwashing sinks,supplied and accessible.Corrective ActionCorrected DuringInspection, Verification,Enforcement ActionIntervention for Long-termCompliance3-301.11(B) - Remove risk offood contamination bydiscarding food, cooking foodto at least 165 F, etc. (C) Change food contact method.3-301.11(B) - Train employeeson how to prevent bare handcontact with exposed RTE food.Provide suitable utensils. (C) Train employees on methods tominimize bare hand and armcontact with non-RTE foods.Provide suitable utensils.3-801.11(D) - If facility servesan HSP, and food iscontacted with bare handsthe food must be discarded.This includes fruits andvegetables that were barehand contacted duringwashing procedure.3-801.11 - Train employees onpreventing all bare handcontact with foods in a facilitythat serves an HSP. Providesuitable utensils.5-202.12(A) - Adjust waterheater. Verify temperaturerise to at least 100 F.5-202.12(A) - Repair/Replaceplumbing system components.Consult licensed plumber.5-203.11(A) - Requireinstallation of additionalhandwash sinks. Ceaseoperation or installtemporary handwashstations if there are nouseable handwash sinks.Consider writing SOPs.5-203.11(A) - Install handwashsinks. Consult licensedplumber.5-204.11(A)(B) - Requirerelocation or installation ofhandwash sinks. Installtemporary handwashstations if there are nohandwash sinks in requiredlocations. Consider writingSOPs.5-204.11(A)(B) - Relocate orinstall handwash sinks. Consultlicensed plumber.5-205.11(A)(B) - Trainemployees.6-301.11 - Train employees.Use a checklist.6-301.12(A)(B)(C)(D) - Trainemployees. Use a checklist.5-205.11(A) - Makeaccessible. (B) - Discontinueunapproved use.6-301.11 - Supply the sinkwith hand cleanser.6-301.12(A)(B)(C)(D) - Supplysink with hand dryingprovision.9
Food Code Reference3-201.11ItemNo.Foodborne Illness RiskFactors and PublicHealth InterventionsCorrective ActionCorrected DuringInspection, Verification,Enforcement Action9Risk Factor:Food from Unsafe Source3-201.11 Discard/reject/return.Voluntary Disposal/Embargo.3-201.12Approved Source:3-201.13Food obtained fromapproved source.3-201.143-201.15Reciprocity of FoodSources from outof-state -201.11(E)(3)(c) - Assess riskand consider allowing PIC toadd label. Discard. VoluntaryDisposal/Embargo.3-201.12, 3-201.13, 3-201.14,3-201.15, 3-201.16, 3-201.17,3-202.13, 3-202.14,3-202.110, 5-101.13 Discard/reject/return.Voluntary Disposal/Embargo.Intervention for Long-termCompliance3-201.11 - Train employees.Change supplier to anapproved vendor that providessupporting documents.3-201.11(E)(3)(c) - Trainemployees.3-201.12, 3-201.13, 3-201.14,3-201.15, 3-201.16, 3-201.17,3-202.13, 3-202.14, 3-202.110,5-101.13 - Train employees.Change supplier to anapproved vendor that providessupporting documents.3-202.1105-101.133-202.1110Risk Factor:Food from Unsafe SourceApproved Source:3-202.11 Discard/reject/return.Voluntary Disposal/Embargo.3-202.11 - Train employees.Change supplier. Verifysupplier is an approved vendorand has proper equipment.3-101.11, 3-202.15 Discard/reject/return.Voluntary Disposal/Embargo.3-101.11, 3-202.15 - Trainemployees. Change supplier.Food received at propertemperature.3-101.113-202.1511Risk Factor:Food from Unsafe SourceApproved Source:Food in good condition, safeand unadulterated.10
Food Code Reference3-202.18ItemNo.Foodborne Illness RiskFactors and PublicHealth InterventionsCorrective ActionCorrected DuringInspection, Verification,Enforcement Action12Risk Factor:Food from Unsafe Source3-202.18, 3-203.12 Discard/reject/return.Voluntary Disposal/Embargo.3-203.12Approved Source:3-402.11Required records available:shellstock tags, parasitedestruction.3-402.12USDA Inspected FacilitiesApproved USDA Packer 11 Discard/reject/return.Voluntary Disposal/Embargo.Cook food to propertemperature.3-402.12 Discard/reject/return.Voluntary Disposal/Embargo.Risk Factor:ContaminatedEquipment/Protectionfrom Contamination3-302.11, 3-304.11 - PIC mustrelocate food items tominimize contamination.Rearrange storage of foods.Protection fromContamination:Discard RTE foodscontaminated from rawspecies foods. Discard thefood if determined to beadulterated from thecontamination. Assess riskand consider option ofcooking the food to 165 F.Food separated andprotected.3-304.15(A) - Discard glovesand wash hands. Discardcontaminated food. Assessrisk and consider cookingcontaminated food to165 F. Clean and sanitizeequipment/utensilsdetermined to becontaminated.Intervention for Long-termCompliance3-202.18, 3-203.12 - Trainemployees. Change suppliers.Create a checklist to verifycertifications and shellstocktags upon receiving. DevelopRCP with log for receivingstock.3-402.11 - Train employees.Change suppliers. Modify menuto exclude these items.3-402.12 - Change recordkeeping procedures.3-302.11, 3-304.11 - Trainemployees. Acquire additionalstorage equipment. Labelshelving and storage areas.Alter storage procedures.3-304.15(A) - Train employees.3-306.13(A) - Alter menuand/or presentation methods.Food Storage Order inRefrigerators and Freezers3-306.13(A) Remove fromconsumer self-service.11
Food Code orne Illness RiskFactors and PublicHealth InterventionsRisk Factor:ContaminatedEquipment/Protectionfrom ContaminationProtection fromContamination:4-501.1144-501.115Food-contact surfaces:cleaned and sanitized.4-601.11(A)Corrective ActionCorrected DuringInspection, Verification,Enforcement ActionIntervention for Long-termCompliance4-501.111, 4-501.112,4-501.113, 4-501.114,4-501.115 - Repair ofequipment and repeat ofsanitization step duringinspection. Switch to manualwashing if capacity allows;rewash/sanitize utensils.Switch to single use utensils.4-501.111, 4-501.112,4-501.113, 4-501.114,4-501.115 - Repair/Replaceequipment. Re-supply chemicalstock.Begin using approvedemergency SOPs. Contactvendor contractor foremergency repair ofequipment. Assess risk andconsider closure if violationcannot be corrected duringinspection (Correctionincludes effective sanitizationmethod and sanitization of allutensils/equipment thatwere not subjected toeffective/approvedsanitization method.)4-602.114-702.114-703.114-601.11(A) - Repeat cleaningprocedure.Develop log to verifycleaning/sanitizing equipmentis working properly (test stripsor thermo-labels). Developan RCP with logs to ensure CIPequipment is cleaned andsanitized per requiredfrequency. Create approvedSOPs for emergencies.sanitizing chemical.4-601.11(A) - Train employees.4-602.11 - Train employees.4-702.11 - Train employees.4-703.11 - Train employees.Repair/replace equipment.Change sanitization methodsused in facility.Prevent Cross-Contamination4-602.11 - Clean the utensilor equipment.4-702.11 - Sanitize the
This manual is intended to provide guidance and assistance with the compliance and enforcement of North Carolina statutes and rules pertaining to Risk Factors and Interventions at regulated retail food and drink establishments. Compliance and enforcement encompasses all voluntary and regulat
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