preventive controls for human...

Preventive Controls for Human Food

First Edition - 2016

Participant Manual

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FOOD SAFETY PREVENTIVE CONTROLS ALLIANCE

Steering Committee (October 2015) JohnT.AllanIII,InternationalDairyFoodsAssociation

(IDFA),Washington,DCGlennBlack,GroceryManufacturersAssociation(GMA),

Washington,DC(PastChairman)(currentlyFDA)RobertE.Brackett,InstituteforFoodSafetyandHealth

–IllinoisInstituteofTechnology(IFSH‐IIT),Chicago,IL

BenjaminChapman,NorthCarolinaStateUniversity,Raleigh,NC(Chairman)

ClaudiaColes,WashingtonDepartmentofAgriculture,Olympia,WA

DebraDeVlieger,U.S.FDA,BainbridgeIsland,WANancyDoyle,U.S.FDA,Beaverton,ORDavidFairfield,NationalGrainandFeedAssociation

(NGFA),Atlantic,IADonnaGarren,AmericanFrozenFoodInstitute(AFFI),

Washington,DCDavidGombas,UnitedFreshProduceAssociation,

Washington,DCKathyGombas,U.S.FDA,CollegePark,MDJohnT.Hoffman,FoodProtectionandDefenseInstitute

(FPDI)–UniversityofMinnesota,St.Paul,MNSonyaM.Lambkin,U.S.FDA,Rockville,MDJohnLarkin,FPDI,St.Paul,MNAnitaMacMullan,NorthCarolinaDepartmentof

AgricultureandConsumerServices,Charlotte,NC

JianghongMeng,JointInstituteforFoodSafetyandAppliedNutrition–UniversityofMaryland,CollegePark,MD

DianneMilazzo,U.S.FDA,CenterforVeterinaryMedicine,Rockville,MD

RamkishanRao,U.S.DepartmentofAgriculture,NationalInstituteofFoodandAgriculture,Washington,DC

DonaldSchaffner,RutgersUniversity,NewBrunswick,NJ

JennyScott,U.S.FDA,CollegePark,MDGuyE.Skinner,IFSH‐FDA,Chicago,ILKatherineM.J.Swanson,KMJSwansonFoodSafety,Inc.,

MendotaHeights,MN(CurriculumDevelopmentProject Manager)

PatTovey,PetFoodInstitute,Washington,DCW.HenryTurlington,AmericanFeedIndustry

Association,Arlington,VAPurnenduC.Vasavada,PCV&AssociatesLLC,River

Falls,WI(Outreach Project Manager)RobertD.Waltz,AssociationofAmericanFeedControl

Officials(AAFCO),WestLafayette,INJasonWan,IFSH‐IIT,Chicago,ILGeraldWojtala,InternationalFoodProtectionTraining

Institute(IFPTI),BattleCreek,MI

Executive Committee (October 2015)

BenjaminChapman,NorthCarolinaStateUniversity,Raleigh,NC(Chair)

ClaudiaColes,WashingtonStateDepartmentofAgriculture,Olympia,WA

DonnaGarren,AFFI,Washington,DCDonaldSchaffner,RutgersUniversity,NewBrunswick,

NJ

KatherineM.J.Swanson,KMJSwansonFoodSafety,Inc.,MendotaHeights,MN(FSPCAProjectManager,CurriculumDevelopment)

PurnenduC.Vasavada,PCV&AssociatesLLC,RiverFalls,WI(FSPCAProjectManager,Outreach)

Editorial Sub‐committee (1stEdition)

JeffreyBarach,BarachEnterprisesLLC,Oakton,VAGlennBlack,GMA,Washington,DC(currentlyFDA)RobertBrackett,IFSH‐IIT,Chicago,ILClaudiaColes,WashingtonStateDepartmentof

Agriculture,Olympia,WADebraDeVlieger,U.S.FDA,BainbridgeIsland,WA

JennyScott,U.S.FDA,CollegePark,MDKatherineM.J.Swanson,KMJSwansonFoodSafety,Inc.,

MendotaHeights,MN(ExecutiveEditor)PurnenduC.Vasavada,PCV&AssociatesLLC,River

Falls,WIJasonWan,IFSH‐IIT,Chicago,IL

Hazard Analysis and Preventive Controls for Human Food Training TheFoodSafetyPreventiveControlsAlliancedevelopedthistrainingcurriculuminFoodSafetyPreventiveControlscompliantwiththeFDA’sCurrentGoodManufacturingPractice,HazardAnalysis,andRisk‐basedPreventiveControlsforHumanFoodregulations.Forthemostcurrentcourseinformation,pleaseconsult:http://www.iit.edu/ifsh/alliance/

ThispublicationwasdevelopedbytheFoodSafetyPreventiveControlsAlliance(FSPCA)andwassupported,inpart,byagrantfromtheFoodandDrugAdministrationtotheIllinoisInstituteofTechnology’sInstituteforFoodSafetyandHealth.Theviewsexpressedhereindonotnecessarilyreflecttheviewsoftheseorganizations.DirectallinquiriestotheFSPCAatfspca@iit.edu

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FSPCA PREVENTIVE CONTROLS FOR HUMAN

FOOD TRAINING CURRICULUM

First Edition – 2016 (Version 1.2, February 2016)

Developed by the

Disclaimer The information provided by the Food Safety Preventive Controls Alliance (FSPCA) is for training purposes only. The FSPCA is not your attorney and cannot provide you with legal advice. The FSPCA curriculum is intended as a training tool to assist companies in complying with the FDA Food Safety Modernization Act (FSMA) preventive controls regulation; however, following this curriculum does not ensure compliance with the law or FDA’s regulations. For advice regarding the legal compliance with FSMA, please consult your legal counsel.

The information provided by the FSPCA will vary in applicability to each food manufacturer. It is not possible for the FSPCA training curriculum to address every situation. Companies should implement the practices and programs that will function best to produce safe foods based on the nature of their individual operations. FSPCA materials do not outline the only approach to developing and implementing a Food Safety Plan. Companies can follow any approach that satisfies the requirements of the applicable statutes and regulations related to FSMA. The information provided by FSPCA does not create binding obligations for the Food and Drug Administration or industry.

FSPCA does not guarantee the accuracy, adequacy, completeness or availability of any information provided in its curriculum and is not responsible for any errors or omissions or for any results obtained from the use of such information. FSPCA gives no express or implied warranties, including but not limited to, any warranties of merchantability or fitness for a particular purpose or use. In no event shall FSPCA be liable for any indirect, special or consequential damages in connection with any use of this training curriculum.

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Version1.2containschangestoaddresstechnicalamendmentsandcorrectionspublishedbyFDA,andeditorialcorrectionsidentifiedinearlierversions.Anerratumlistingforearlier

versionsisavailableontheFSPCAwebsite.Contributors: FSPCA Preventive Controls for Human Food Training Curriculum

TheseWorkingGroupsandindividualsmadesignificantcontributionsoftimeandexpertiseindevelopingtheFoodSafetyPreventiveControlsAlliancetrainingcurriculumandsupportingdocumentssinceitsinceptionin2012.Affiliationswhileworkwasinprogressarenoted.

FSPCA Preventive Controls Core Curriculum Development JeffBarach,BarachEnterprises–ChairJudyFraserHeaps,LandO’Lakes,Inc.–ViceChair

Food Categories and Representative Processing KurtDeibel,Heinz,NorthAmerica–ChairAlejandroMazzotta,Chobani,Inc.–ViceChairTimJackson,NestléNorthAmerica

Allergen Management and Controls JosephScimeca,Cargill,Inc.–ChairSueEstes,PepsiCo,Inc.–ViceChair

Sanitation, Current Good Manufacturing Practices and Environmental Monitoring JohnAllan,AmericanFrozenFoodInstitute–ChairJoeShebuski,Cargill,Inc.–ViceChair

Supply Chain and Ingredient Management SteveMavity,BumbleBeeFoods,Inc.–ChairFayeFeldstein,DeloitteConsulting,LLC–ViceChair

Thefollowingpeopleororganizationsmadesignificantcontributionstothecontentofspecificchapters:

Sanitation Control Plan AmericanFrozenFoodInstitute,CargillInc.,EcolabInc.,LeprinoFoods

Recall GroceryManufacturersAssociation

Class Exercise Activities JudyFraser‐Heaps,LandO’Lakes,Inc.PamelaWilger,Cargill,Inc.KatherineSimons,MinnesotaDepartmentofAgriculture

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TABLE OF CONTENTS Food Safety Preventive Controls Alliance (FSPCA) .................................................................................. iv

FSPCA Preventive Controls for Human Foods Course Agenda ............................................................... vi

Chapter 1: Introduction to Course and Preventive Controls .................................................................. 1‐1

Chapter 2: Food Safety Plan Overview .................................................................................................... 2‐1

Chapter 3: Good Manufacturing Practices and Other Prerequisite Programs ....................................... 3‐1

Chapter 4: Biological Food Safety Hazards .............................................................................................. 4‐1

Chapter 5: Chemical, Physical and Economically Motivated Food Safety Hazards ............................... 5‐1

Chapter 6: Preliminary Steps in Developing a Food Safety Plan ............................................................ 6‐1

Chapter 7: Resources for Food Safety Plans ............................................................................................ 7‐1

Chapter 8: Hazard Analysis and Preventive Controls Determination .................................................... 8‐1

Chapter 9: Process Preventive Controls .................................................................................................. 9‐1

Chapter 10: Food Allergen Preventive Controls ...................................................................................... 10‐1

Chapter 11: Sanitation Preventive Controls ............................................................................................ 11‐1

Chapter 12: Supply‐chain Preventive Controls........................................................................................ 12‐1 Chapter 13: Verification and Validation Procedures .............................................................................. 13‐1 Chapter 14: Record‐keeping Procedures ................................................................................................. 14‐1

Chapter 15: Recall Plan ............................................................................................................................ 15‐1 Chapter 16: Regulation Overview – cGMP, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food ................................................................................................... 16‐1

Appendix 1: FDA Regulation on cGMPs, Hazard Analysis, and Risk‐based Preventive Controls

for Human Food ................................................................................................................... A1‐1

Appendix 2: Food Safety Plan Worksheets ............................................................................................. A2‐1

Appendix 3: Food Safety Plan Example: Frozen Omelets ....................................................................... A3‐1

Appendix 4: Foodborne Pathogen Supplementary Information ............................................................ A4‐1

Appendix 5: Sanitation Basics ................................................................................................................. A5‐1

Appendix 6: Hygienic Zoning and Environmental Monitoring Supplemental Information ................... A6‐1

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Food Safety Preventive Controls Alliance The Food Safety Preventive Controls Alliance (FSPCA) providescurrentandcost‐effectiveeducationandtrainingprogramstoassistthefoodindustrytoachievecompliancewiththeU.S.FoodandDrugAdministration (FDA) Hazard Analysis and Risk‐based PreventiveControls for Human Food regulation, which is referred to as thePreventive Controls for Human Food regulation throughout thiscourse.Therequirementsofthisregulationaredesignedtopromotesafe food production. The structure and the delivery of the FSPCAPreventive Controls forHuman Food training course were built onsuccessful examples from two previous alliances – SeafoodHACCPandJuiceHACCP.

This course developed by FSPCA is the “standardized curriculum”recognizedbyFDA;successfullycompletingthiscourseisonewaytomeet the requirements for a “preventive controls qualifiedindividual.” Note: Under the Preventive Controls for Human Foodregulation, the responsibilities of a “preventive controls qualifiedindividual”includetoperformoroversee1)preparationoftheFoodSafetyPlan,2)validationofthepreventivecontrols,3)recordsreviewand4)reanalysisoftheFoodSafetyPlan.

TheFSPCAprogramisbasedoncollaborationamongfederalandstateregulatoryofficials,academicfoodsafetyresearchersandeducatorsandU.S.foodindustryrepresentatives.TheprogramisdirectedbyavoluntaryFSPCASteeringCommittee,whosemembersarelistedonthe inside front cover. The FSPCA Steering Committee directsdevelopmentofthecurriculum,alltrainingmaterialsandtheFSPCATraining Protocol for delivering, documenting and updating thesematerials. Any individual, company, agency or nation can provideinput for the FSPCA program through communications with anymember of the FSPCA Steering Committee. Participation in sub‐committees and working groups is also possible. Visit the FSPCAwebsite for information on active sub‐committees and workinggroups.

The Association of Food and Drug Officials (AFDO) and theInternational FoodProtectionTraining Institute (IFPTI) administercertificates for all participants that complete a recognized FSPCAPreventive Controls for Human Food course. Contact IFPTI forquestionsoncertificatesorhowtobecomeanFSPCALeadInstructor.

TheFSPCAPreventiveControlsforHumanFoodcoursewillbeofferedinbotha formalclassroomsettingandaself‐guidedonlineversionthatiscoupledwithaone‐day,inpersonsessiontodevelopskillsforconductingahazardanalysisanddevelopingaFoodSafetyPlan.TheFSPCAtrainingmaterialsincludethestandardtrainingmanual,slides,explanations of key terms and concepts, an example model FoodSafety Plan, abbreviated models for class exercises and referencematerial. Examples ofmodel Food Safety Plans for processed food

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products are maintained on the FSPCA website(http://www.iit.edu/ifsh/alliance/). These examples are forreference,andmodificationsofexampleplanswillbenecessaryforspecificfacilities.

TheFSPCAtrainingmaterialsaredesignedtomeettherequirementsfor training under Title 21 Code of Federal Regulations Part117.180(c)(1) for the preventive controls qualified individualwhoconducts certain Food Safety Plan activities. Attending an FSPCAcourse is not mandatory, but it does provide assurances that thecoursecontentandresultingknowledgeisconsistentwithregulatoryexpectations.

The FSPCA coursematerial and information on training for FSPCALeadInstructorscanbefoundontheFSPCAwebsite.

History of the Alliance TheFSPCAwasestablishedin2011aspartofagrantfromFDAtotheIllinoisInstituteofTechnology’sInstituteofFoodSafetyandHealth.Thepurposeofthisbroad‐basedallianceistodevelopandmaintainacost‐effective education and training program to assist the foodindustry with understanding and achieving compliance with thePreventive Controls regulation requirements applicable to theirfacilities.Bothhumanfoodandanimalfoodregulationsarecoveredin separate courses. FSPCA’s mission is to support safe foodproduction by developing a standardized curriculum and technicaleducational materials on food safety risk‐reduction controlscompliant with the Preventive Controls regulations, and providingtechnicalassistanceoutreachtothefoodindustry,particularlysmallfoodcompanies.

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FSPCA Preventive Controls for Human Food Course Agenda Theagendaisintendedtobecoveredina2.5day(20hours)course,includingfrequentopportunitiesforreviewandclassroomexercisesdesigned to provide learning opportunities for understandingPreventive Controls for Human Food regulation requirements. Thetimeallottedtoeachsectionwillvarybasedontheaudience,leveloffamiliarity and experience with GoodManufacturing Practices andrisk‐based food safety principles, as well as the food product andprocessingunderconsideration.Atypicalagendaappearsbelow.

Day One Chapter 1 Introduction to Course and Preventive Controls Chapter 2 Food Safety Plan Overview Break Chapter 3 Good Manufacturing Practices and Other Prerequisite

Programs Chapter 4 Biological Food Safety Hazards Lunch Chapter 5 Chemical, Physical and Economically Motivated Food Safety

Hazards Break Chapter 6 Preliminary Steps in Developing a Food Safety Plan Chapter 7 Resources for Preparing Food Safety Plans

Day Two Review and Questions Chapter 8 Hazard Analysis and Preventive Controls Determination Break Chapter 9 Process Preventive Controls Lunch Chapter 10 Food Allergen Preventive Controls Break Chapter 11 Sanitation Preventive Controls Chapter 12 Supply‐chain Preventive Controls

Day Three Review and Questions Chapter 13 Verification and Validation Procedures Chapter 14 Record‐keeping Procedures Break Chapter 15 Recall Plan Chapter 16 Regulation Overview – cGMP, Hazard Analysis, and Risk‐Based

Preventive Controls for Human Food Wrap Up

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CHAPTER 1. Introduction to Course and Preventive Controls

TheCurrentGoodManufacturingPractice,HazardAnalysis,andRisk‐based Preventive Controls for Human Food regulation (hereafterreferredtoasthePreventiveControlsforHumanFoodregulation)waspublished on September 17, 2015 and is intended to ensure safemanufacturing/processing,packingandholdingoffoodproductsforhumanconsumptionintheUnitedStates.Theregulationrequiresthatcertain activities must be completed by a “preventive controlsqualifiedindividual”whohas“successfullycompletedtraininginthedevelopment and application of risk‐based preventive controls atleast equivalent to that received under a standardized curriculumrecognizedasadequatebyFDAorbeotherwisequalifiedthroughjobexperiencetodevelopandapplyafoodsafetysystem”(seeChapter16:RegulationOverviewandAppendix1).

ThiscoursedevelopedbytheFSPCAisthe“standardizedcurriculum”recognizedbyFDA;successfullycompletingthiscourseisonewaytomeet the requirements for a “preventive controls qualifiedindividual.”

Thischapterreviewstheformatforthecourseandprovidesabriefoverviewofhowpreventivecontrolsbuildonestablishedfoodsafetyprinciples. It then explores the responsibilities of a preventivecontrolsqualifiedindividualtohelpyoutounderstandthetasksthatyouwill be expected either to do or to oversee. At the end of thechapter,youwillalsoseealistofdefinitionstohelpyouunderstand

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themeaningofspecifictermsusedinthecourse,mostofwhicharefromthePreventiveControlsforHumanFoodregulation.

Course Format and Agenda

TheFSPCAcourseisdividedintothreeparts:

1. The first part defines the contents of the Food Safety Plan,reviews foundational programs such as GMPs, providesinformation about specific food hazards and discusses theunderlyingprinciplesusedinfoodsafetypreventivecontrolssystems.Learninghowtoapplythesepracticesandprincipleswillgiveabetterunderstandingofhowasystematicapproachcan help to assure the safety of food. As each principle isdiscussed,theclasswillprogressivelydevelopaFoodSafetyPlan for amodel product produced by a fictional company.Thisexamplewillhelpyouunderstandhowtoput togethereach section of a Food Safety Plan and how these sectionsrelate to a complete preventive controls program and safefoodprocessing.

2. The second part includes practical exercises that introducethe participants to the process of developing a Food SafetyPlan, including identification of tools and implementationtasks.Duringthispart,theclasswillbedividedintoteamstowriteasimplifiedFoodSafetyPlanforaselectedfoodproduct.

3. The third part explains the requirements of the PreventiveControlsforHumanFoodregulation.

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Risk‐based Preventive Controls

Aproactiveandsystematicapproachtofoodsafetyemphasizingthepreventive controls approach has been universally accepted andadoptedthroughouttheworldbecauseithelpstofocusattentiononthemost important areas toprevent foodsafety issues rather thanreactingtoproblemsastheyarise.Preventivecontrolprogramsarestructured towork in conjunctionwith and be supported by otherrelevant programs such as Good Manufacturing Practices (GMPs),goodagriculturalpracticesandgoodtransportationpracticesasthebasis for food safety management. Successful application ofpreventivecontrolsapproachesnotonlyhelpstoensureregulatorycompliance,butalsominimizes theriskofproducingproducts thatcanharmconsumers

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Risk‐based approaches to managing food safety were pioneeredduringdevelopmentoffoodfortheU.S.spaceprograminthe1 60s.At that time, end‐product testing was the focus of quality controlprograms.Itbecameevidentthattheend‐producttestingnecessarytoprovideassurancethatthefoodwassafewouldbesoextensivethatlittle foodwouldbeavailable for space flights.The focus shifted topreventinghazardsthroughproductformulationandprocesscontrolinarisk‐basedmanner.TheconceptwascalledHazardAnalysisandCritical Control Point (HACCP). HACCP implementation expandedvoluntarily in the food industry with the understanding that foodsafetyisbestassuredifeachproducerandprocessorunderstandsthesignificant hazards in their product and operation, and usesscientificallysoundpreventivecontrols tosignificantlyminimizeoreliminatethehazards.

Inthe1 70s,FDAusedHACCPprinciplesinthedevelopmentoflow‐acidcannedfoodregulations.TheU.S.NationalAdvisoryCommitteeon Microbiological Criteria for Foods (NACMCF) and the CodexAlimentariusCommission(Codex)publishedHACCPprinciplesinthe1 0s. FDAhasHACCP regulations for seafood and juice products;USDA has HACCP regulations for meat and poultry products; andHACCP isendorsedbymanycountries, includingAustralia,Canada,New ealandandEuropeanUnioncountries.

HACCPprinciplesareillustratedintheslideabove.AquickreviewoftheseprinciplesisusefultounderstandhowthePreventiveControlsfor Human Food regulation complements the risk‐based HACCPapproach.

InaHACCPsystem,hazardanalysisidentifiesprocess‐relatedhazardsthat,intheabsenceofcontrol,presentafoodsafetyrisk.Whenthesehazardsareidentified,CriticalControlPoints(CCPs)thatareessentialtocontroltheprocesstopreventthehazardfromcausingillnessor

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injuryareidentified.WhentheseCCPprocesscontrolsareidentified,thecriticallimitsdefinetheoperatingconditionsintheprocessthatmust be met to effectively manage the hazard. Monitoring of theprocessisdonetoprovidedatatodemonstratethatcriticallimitsaremet,andcorrectiveactionsarepredefinedtoenableswiftactionwhenthingsgowrong,thuspreventingexpansionofafoodsafetyissue.Alloftheaboveisrecordedandverifiedtoensurethesystemisoperatingasintendedandtoprovidedatatoothers(e.g., inspectors,auditors,management, new employees) to show that this is the case. Moreinformation on each of these principles is discussed in thiscurriculum,recognizingthataHACCPPlanessentiallyaddressesmostoftherequirementsforprocesspreventivecontrols.

However, the preventive controls process incorporates controlsbeyond those managed as process‐related CCPs in the HACCPframework.ThesepreventivecontrolsaddressnotonlyCCPs,butalsocontrols for hazards related to food allergens, sanitation, suppliersand others requiring a preventive control. The preventive controlsapproachalsorecognizesthatcriticallimits,definedbyNACMCFas:“Amaximumand/orminimumvaluetowhichabiological,chemicalor physical parameter must be controlled at a CCP to prevent,eliminateorreducetoanacceptableleveltheoccurrenceofafood‐safetyhazard”maynotberequiredforsomepreventivecontrols.Thebroader term, parameters and values, supports identification of afrequencyorothermetrictoassesscompliance,ratherthansettingapreciseminimumormaximumvaluetowhichaparametermustbecontrolled. Further, immediate corrections (like re‐cleaning a linebefore start up) may be more appropriate than formal correctiveaction involving product risk evaluations for some preventivecontrols.Finally,theextentofvalidationactivities(ordemonstratingthecontrolsactuallywork)maybelessrigorousforsomepreventive

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controls thanothers.Eachof theseconcepts isdiscussed ingreaterdetailinsubsequentchapters.

Contents of a Food Safety Plan

TheFoodSafetyPlanisadynamicdocument,whichmustbekeptcurrentifchangesaremadetothesystemortoequipmentwhennewproductsareadded,ornewhazardsareidentified.TheschematicaboveillustratesthattheFoodSafetyPlanincludesanumberofelements.Itstartswithhazardanalysis,whichisusedtoidentifyrequiredpreventivecontrolsfor the process, for sanitation, for food allergens and supply‐chainprograms,where theseareneeded toaddress thehazardsrequiringapreventivecontrol.Theseelements,alongwitharecallplanmakeuptheFood Safety Plan. Many GMPs and other prerequisite programs aremanaged outside of the Food Safety Plan. While these are separateprogramsandmaynotrequirethesamelevelofdocumentationastheelementsoftheFoodSafetyPlan,theyareimportant.Theyaregenerallymanaged using standard operating procedures with documents andrecordskeptasappropriate.KeepinmindthatelementsofGMPsthatarenotcoveredintheFoodSafetyPlanarestillrequiredbyregulations.

GMPs are required because they form the foundation for your Food Safety Plan. Developing a Food Safety Plan helps you to focus most of your activities on what matters most for food safety.

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Preventive Controls Qualified Individual

Undertheregulation,certaintasksmustbeperformed(oroverseen)bya“preventivecontrolsqualifiedindividual.”Thiscoursedevelopedby FSPCA is the “standardized curriculum” recognized by FDA;successfully completing this course is one way to meet therequirementsfora“preventivecontrolsqualifiedindividual.”Underthe Preventive Controls for Human Food regulation, theresponsibilitiesofa“preventivecontrolsqualifiedindividual”includeto perform or oversee 1) preparation of the Food Safety Plan, 2)validation of the preventive controls, 3) records review and 4)reanalysisoftheFoodSafetyPlan.

Thepreventivecontrolsqualifiedindividualmaybeanemployeeofthefacilitybutyoucanalsouseoutsideassistanceindevelopingyourplan.Insomesituations,morethanonepreventivecontrolsqualifiedindividual may be needed to effectively develop and implement aFoodSafetyPlan.MoredetailonthedifferentpartsoftheFoodSafetyPlanisprovidedinthiscourse.

See the 21 CFR 117.3 definitions for “qualified individual” and “preventive controls qualified individual,” as well as the 21 CFR 117.180 requirements applicable to a preventive controls qualified individual in Appendix 1.

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What is Expected of the Participant?

Prevention‐basedfoodsafetymanagementcanbeintegratedintoanyoperation;however,theprocesscanseemcomplicateduntilthebasicconcepts are understood. Asking questions and contributing first‐hand experiences during the discussions can help you and otherparticipantstobetterunderstandandapplytheconcepts.Thiscourseincludesclassparticipationandexercises.Themoreyoucontributetothese exercises, the less complicated the systemwill seem and theeasier itwillbe todevelopand implementaneffectiveFoodSafetyPlan.

How to Use This Training Manual Thismanualisyours.Becomefamiliarwithitanduseitasareference.Itcontains formsthatcanhelpyoudevelopaFoodSafetyPlanandresourcestolocateotherbasicinformation.Makeasmanynotesandmarks in the manual as needed to assist you in creating andunderstanding a Food Safety Plan. This manual does not have acopyright.Makeasmanycopiesoftheformsasnecessaryorcopythewholemanualtosharewithothersinyourcompany.

As you learnmore about developing a Food Safety Plan, there aremany definitions that you need to understand. To assist you, thedefinitionsofmanycommonlyusedtermsarelistedattheendofthechapter.Refer to thesepagesasneeded. oumayalsowant toaddothertermsthatyoumayneedindevelopingandimplementingyourownFoodSafetyPlan.

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Introduction Summary

By successfully completing this course, you will meet the trainingrequirementsfora“preventivecontrolsqualifiedindividual”whocanoversee a food safety preventive controls program. oumay needassistance from technical experts for certain elementsofyour foodsafety program, which will be discussed in chapters later in thecourse.

Throughthiscourseyouwilllearnhowtodeveloparisk‐basedFoodSafetyPlanandimplementpreventivecontrolstohelpmitigateandcontrolhazardsspecific foryourproductandprocess.Thisreducespotential food safety issues for thepublic and for yourbusiness aswell.

Participation is vital for understanding the material and yourexperienceandquestionscanhelpothersinthecourseaswell.Pleaseparticipatetogetasmuchoutofthiscourseasyoupossiblycan.

Definitions and Acronyms Acidfoodsoracidifiedfoods3:FoodsthathaveanequilibriumpHof4.6or below. (NOTE: acid foods have a natural pH of 4.6 or below;acidifiedfoodshaveacidaddedtoreducethepH.)

Adequate3:Thatwhichisneededtoaccomplishtheintendedpurposeinkeepingwithgoodpublichealthpractice.

Allergencross contact3:Theunintentional incorporationofa foodallergenintoafood.

Audit3: means the systematic, independent, and documentedexamination (through observation, investigation, records review,discussionswithemployeesoftheauditedentity,and,asappropriate,

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sampling and laboratory analysis) to assess an entity’s food safetyprocessesandprocedures.

aW:Wateractivity(seebelow)

CCP:CriticalControlPoint(seebelow)

cGMPs: Current Good Manufacturing Practices (see “GMPs” andChapter3)

Cleaning2: The removal of soil, food residue, dirt, grease or otherobjectionablematter.

Correction3:meansanactiontoidentifyandcorrectaproblemthatoccurred during the production of food, without other actionsassociated with a corrective action procedure (such as actions toreducethelikelihoodthattheproblemwillrecur,evaluateallaffectedfoodforsafety,andpreventaffectedfoodfromenteringcommerce).

Corrective action5: Procedures that must be taken if preventivecontrolsarenotproperlyimplemented.

CriticalControlPoint(CCP)3:Apoint,step,orprocedureinafoodprocessatwhichcontrolcanbeappliedandisessentialtopreventoreliminateafoodsafetyhazardorreducesuchhazardtoanacceptablelevel.

Critical limit4:Themaximumorminimumvalue,orcombinationofvalues,towhichanybiological,chemicalorphysicalparametermustbecontrolledtosignificantlyminimizeorpreventahazardrequiringaprocesspreventivecontrol.

Cross contact:seeallergencross‐contact

Cross contamination: The unintentional transfer of a foodbornepathogen froma food (where itmayoccurnaturally) or insanitaryobjecttoanotherfood(whereitmaypresentahazard).

Defect action level3: means a level of a non‐hazardous, naturallyoccurring, unavoidable defect at which FDA may regard a foodproduct “adulterated” and subject to enforcement action undersection402(a)(3)oftheFederalFood,Drug,andCosmeticAct.

Deviation2, :Failuretomeetacriticallimit.

e.g.:Forexample,(Latinexempligratia)

Environmental pathogen3: A pathogen capable of surviving andpersistingwithinthemanufacturing,processing,packingorholdingenvironmentsuchthatfoodmaybecontaminatedandmayresultinfoodborne illness if that food is consumed without treatment tosignificantly minimize the environmental pathogen. Examples ofenvironmentalpathogensforthepurposesofthispartincludeListeriamonocytogenesandSalmonellaspp.butdonotincludethesporesofpathogenicsporeformingbacteria.

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Facility3: A domestic facility or foreign facility that is required toregisterundersection415of theFederalFood,Drug,andCosmeticAct,inaccordancewiththerequirementsof21CFRpart1,subpartH.

FDA:FoodandDrugAdministration

Food6: Includes(1)articlesusedforfoodordrinkformanorotheranimals,(2)chewinggum,and(3)articlesusedforcomponentsofanysuch article. Examples of food include fruits, vegetables, fish, dairyproducts, eggs, raw agricultural commodities used for food or ascomponentsoffood,animalfeed(includingpetfood),foodandfeedingredients,foodandfeedadditives,dietarysupplementsanddietaryingredients,infantformula,beverages(includingalcoholicbeveragesand bottled water), live food animals, bakery goods, snack foods,candy,andcannedfoods.Doesnotincludepesticidesorfoodcontactsubstancesnotintendedtohaveanytechnicaleffectinthefood.

Food allergen7:Any of the following: (1)Milk, egg, fish (e.g., bass,flounderorcod),Crustaceanshellfish(e.g.,crab,lobsterorshrimp),tree nuts (e.g., almonds, pecans or walnuts), wheat, peanuts andsoybeans.(2)Afoodingredientthatcontainsproteinderivedfromafoodspecifiedinparagraph(1),exceptanyhighlyrefinedoilderivedfrom a food specified in paragraph (1) and any ingredient derivedfromsuchhighlyrefinedoil.

Food contactsurface3:Thosesurfacesthatcontacthumanfoodandthosesurfacesfromwhichdrainage,orothertransfer,ontothefoodor onto surfaces that contact the foodordinarily occursduring thenormalcourseofoperation.“Foodcontactsurfaces”includesutensilsandfood‐contactsurfacesofequipment.

FoodSafetyPlan:Asetofwrittendocumentsthatisbasedonfoodsafetyprinciples; incorporateshazardanalysis,preventivecontrols,supply‐chain programs and a recall plan; and delineates theprocedures to be followed for monitoring, corrective actions andverification.

Foodsafetysystem:TheoutcomeofimplementingtheFoodSafetyPlananditssupportingelements.

GMPs(GoodManufacturingPractices):Theregulation(117SubpartB) that outlines the conditions and practices the regulated foodindustry must follow for processing safe food under sanitaryconditions, including personnel, plant and grounds, sanitaryoperations, sanitary facilities and controls, equipment andutensils,processes and controls, warehousing and distribution, and defectactionlevelsconsiderations.

HACCP:HazardAnalysisandCriticalControlPoint(seebelow)

Hazard 3: Any biological, chemical (including radiological), orphysicalagentthathasthepotentialtocauseillnessorinjury.

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Hazard analysis: The process of collecting and evaluatinginformationonhazardsandconditions leading to theirpresence todecidewhich are significant for food safety and thereforemust beaddressedintheHACCPorFoodSafetyPlan.

Hazard Analysis and Critical Control Point2: A system whichidentifies, evaluates, and controls hazardswhich are significant forfoodsafety.

Hazard requiring a preventive control3: means a known orreasonably foreseeable hazard for which a person knowledgeableaboutthesafemanufacturing,processing,packing,orholdingoffoodwould,basedontheoutcomeofahazardanalysis(whichincludesanassessmentoftheseverityoftheillnessorinjuryifthehazardweretooccurandtheprobabilitythatthehazardwilloccurintheabsenceofpreventive controls), establish one ormore preventive controls tosignificantly minimize or prevent the hazard in a food andcomponents to manage those controls (such as monitoring,corrections or corrective actions, verification, and records) asappropriatetothefood,thefacility,andthenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem.

Knownorreasonablyforeseeablehazard3:Abiological,chemical(includingradiological),orphysicalhazardthatisknowntobe,orhasthepotentialtobe,associatedwiththefacilityorthefood.

Lot3:Thefoodproducedduringaperiodoftimeandidentifiedbyanestablishment’sspecificcode.

Microorganisms3: east, molds, bacteria, viruses, protozoa andmicroscopicparasitesand includes species that arepathogens.Theterm “undesirablemicroorganisms” includes thosemicroorganismsthatarepathogens,thatsubjectfoodtodecomposition,thatindicatethatfoodiscontaminatedwithfilth,orthatotherwisemaycausefoodtobeadulterated.

Monitor3: To conduct a planned sequence of observations ormeasurementstoassesswhethercontrolmeasuresareoperatingasintended.

NACMCF (NationalAdvisoryCommitteeonMicrobiological Criteriafor Foods)10: CharteredunderUSDA to provide impartial, scientificadvicetoU.S.Federalfoodsafetyagenciesforuseinthedevelopmentofanintegratednationalfoodsafetysystemsapproachfromfarmtofinal consumption to assure the safety of domestic, imported, andexportedfoods.

Non food contactsurface:Thosesurfacesthatdonotcontacthumanfoodandfromwhichdrainage,orothertransfer,ontothefoodorontosurfaces that contact the food ordinarilydoesnot occur during thenormalcourseofoperation.

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Operatinglimits :Criteriathataremorestringentthancriticallimitsandthatareusedbyanoperatortoreducetheriskofadeviation.

Parameter: a characteristic, feature ormeasurable factor that canhelpindefiningaparticularsystem.

Pathogen3:Amicroorganismofpublichealthsignificance.

Pest3:Anyobjectionableanimalsorinsectsincludingbirds,rodents,flies,andlarvae.

Potablewater:WaterthatmeetsthestandardsfordrinkingpurposesoftheStateorlocalauthorityhavingjurisdiction,orwaterthatmeetsthe standards prescribed by the U.S. Environmental ProtectionAgency’sNationalPrimaryDrinkingWaterRegulations(40CFR141).

Prerequisiteprograms:Procedures,includingGoodManufacturingPractices(GMPs),thatprovidethebasicenvironmentalandoperatingconditionsnecessarytosupporttheFoodSafetyPlan.

Preventive controls3: Those risk‐based, reasonably appropriateprocedures, practices and processes that a person knowledgeableaboutthesafemanufacturing,processing,packingorholdingoffoodwould employ to significantly minimize or prevent the hazardsidentified under the hazard analysis that are consistent with thecurrent scientific understanding of safe food manufacturing,processing,packagingorholdingatthetimeoftheanalysis.

Preventive controls qualified individual3: A qualified individualwho has successfully completed training in the development andapplication of risk‐based preventive controls at least equivalent tothat received under a standardized curriculum recognized asadequatebyFDAorisotherwisequalifiedthroughjobexperiencetodevelopandapplyafoodsafetysystem.

Qualifiedauditor3:Apersonwhoisaqualifiedindividualasdefinedbelow and has technical expertise obtained through education,trainingorexperience(orcombinationthereof)necessarytoperformthe auditing function as required by 117.180(c)(2). Examples ofpotentialqualifiedauditorsinclude:

(1) A government employee, including a foreign governmentemployee;and(2) An audit agent of a certification body that is accredited inaccordancewithregulationsinpart1,subpartMofthischapter.

Qualifiedindividual3:apersonwhohastheeducation,training,orexperience (or a combination thereof) necessary to manufacture,process, pack, or hold clean and safe food as appropriate to theindividual’sassignedduties.Aqualifiedindividualmaybe,butisnotrequiredtobe,anemployeeoftheestablishment.

RTE(Ready to eat)food3:Anyfoodthatisnormallyeateninitsrawstate or any other food, including a processed food, forwhich it is

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reasonably foreseeable that the foodwill be eatenwithout furtherprocessingthatwouldsignificantlyminimizebiologicalhazards.

Reanalysis:Averificationprocedure toassure that theFoodSafetyPlanremainsvalidandthefoodsafetysystemisoperatingaccordingtotheplan(seeSection117.170).

Receiving facility3: A facility that is subject to subpart C HazardAnalysisandRisk‐basedPreventiveControls andsubpartG Supply‐ChainProgram ofthispartandthatmanufactures/processesarawmaterialoringredientthatitreceivesfromasupplier.

Rework3: Clean, unadulterated food that has been removed fromprocessing for reasonsother than insanitaryconditionsor thathasbeensuccessfullyreconditionedbyreprocessingandthatissuitableforuseasfood.

Risk1:A functionof the probabilityof an adversehealth effect andtheseverityofthateffect,consequentialtoahazard(s)infood.

Safe moisturelevel3:Alevelofmoisturelowenoughtopreventthegrowthofundesirablemicroorganismsinthefinishedproductunderthe intended conditions ofmanufacturing, processing, packing, andholding. The safe moisture level for a food is related to its wateractivity(aw).Anawwillbeconsideredsafeforafoodifadequatedataareavailablethatdemonstratethatthefoodatorbelowthegivenawwillnotsupportthegrowthofundesirablemicroorganisms.

Sanitize3:Toadequately treat cleanedsurfacesbyaprocess that iseffective in destroying vegetative cells of pathogens, and insubstantially reducing numbers of other undesirablemicroorganisms, butwithout adversely affecting the product or itssafetyfortheconsumer.

Sanitary conditions: The result of a combination of cleaning andsanitizing, as appropriate for the environment, that prevents theadulterationoffood.

Severity8:Theseriousnessoftheeffectsofahazard.

Significantlyminimize3:Toreducetoanacceptablelevel,includingtoeliminate.

Smallbusiness3:Abusiness(includinganysubsidiariesandaffiliates)employingfewerthan500full‐timeequivalentemployees.

SOP:StandardOperatingProcedure

Supplier3:Theestablishmentthatmanufactures/processesthefood,raises theanimal,orgrows the food that isprovided toareceivingfacility without further manufacturing/processing by anotherestablishment, except for further manufacturing/processing thatconsists solelyof theadditionof labelingor similaractivityof ademinimisnature.

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Supply chain appliedcontrol3:Apreventivecontrolforahazardina raw material or other ingredient when the hazard in the rawmaterialorotheringredientiscontrolledbeforeitsreceipt.

Unexposedpackagedfood3:Packagedfoodthatisnotexposedtotheenvironment.

Validation3: Obtaining and evaluating scientific and technicalevidencethatacontrolmeasure,combinationofcontrolmeasures,orthe food safety plan as a whole, when properly implemented, iscapableofeffectivelycontrollingtheidentifiedhazards.

Verification3:Theapplicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,todeterminewhetheracontrolmeasureorcombinationofcontrolmeasuresisorhasbeenoperatingasintendedandtoestablishthevalidityofthefoodsafetyplan.

Very small business3: A business (including any subsidiaries andaffiliates)averaginglessthan 1,000,000,adjustedforinflation,peryear,duringthe3‐yearperiodprecedingtheapplicablecalendaryearin sales of human food plus the market value of human foodmanufactured,processed,packed,orheldwithoutsale(e.g.,heldforafee).

Wateractivity3(aW):Ameasureofthefreemoistureinafoodandisthequotientofthewatervaporpressureofthesubstancedividedbythevaporpressureofpurewateratthesametemperature.

Written procedures for receiving raw materials and otheringredients3:Writtenprocedurestoensurethatrawmaterialsandotheringredientsarereceivedonlyfromsuppliersapprovedbythereceiving facility (or, when necessary and appropriate, on atemporarybasisfromunapprovedsupplierswhoserawmaterialsorother ingredients are subjected to adequate verification activitiesbeforeacceptanceforuse).

Sourceofdefinitions:1 Food and Agriculture Organization/World Health Organization (FAO/WHO). 2014.SectionIV.RiskAnalysis,CodexAlimentariusProceduralManual,22ndEdition.

2FAO/WHO.2003.GeneralPrinciplesonFoodHygiene.CAC/RCP1‐1 6 ,Rev.4‐20033FoodandDrugAdministration(FDA).21CFR117.3Definitions4FDA.Derivedfrom21CFR117.135(c)(1)(ii)5FDA.Derivedfrom21CFR117.150(a)(1)6FDA.Section201(f)oftheFederalFood,DrugandCosmeticAct7FDA.Section201(qq)–Basedonrequirementsinthatsection8 National Advisory Committee on Microbiological Criteria for Foods. 1 8. HazardAnalysis and Critical Control Point Principles andApplication Guidelines. JournalofFoodProtection61( ):1246‐125 . National Seafood HACCP Alliance. 2011.Hazard Analysis and Critical Control PointTrainingCurriculum.5thed.

10UnitedStatesDepartmentofAgriculture,2014.AdvisoryCommitteeReports.

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CHAPTER 2. Food Safety Plan Overview

The Food Safety Plan is the primary document that guides yourpreventive controls food safety system. The Food Safety Plan isdevelopedusingasystematicapproachtoidentifythosehazardsthatrequire preventive controls to prevent foodborne illness or injury.ThischapterprovidesanoverviewofthecomponentsofaFoodSafetyPlanthatareneededtocomplywiththePreventiveControlsforHumanFoodregulation.

Thismodulealsoprovidesa fewexamplesofoutbreaksandrecallsthatoccurredwhenpreventivecontrolsthatshouldbeincludedinaFood Safety Plan were lacking. Learning from past outbreaks andrecalls canhelpprotect consumers andyourbusiness fromsimilarunfortunateincidents.

AsdiscussedinChapter1,therequirementsinthePreventiveControlsforHumanFoodregulationarebasedonwell‐establishedfoodsafetyprinciples. This chapter also provides a brief discussion of thesystematicprocessinvolvedinbuildingaFoodSafetyPlan.

While this chapterprovidesanoverview tohelpyouvisualizehowyoumightstructureaFoodSafetyPlanspecifictoyouroperation,thedetailsarecoveredinchapterslaterinthecourse.

Definitions:

Food Safety Plan: A set of written documents that is based on food safety principles; incorporates hazard analysis, preventive controls, supply‐chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions and verification. Food safety system: The outcome of implementing the Food Safety Plan and its supporting elements.

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AwrittenhazardanalysisisthefirstrequiredelementinaFoodSafetyPlan.When thehazard analysis process identifies hazards requiring apreventivecontrol, thewrittenpreventivecontrolsportionof theplanmust address relevant process preventive controls, food allergenpreventive controls, sanitation preventive controls, supply‐chain orotherpreventivecontrols.Thesearethepreventivecontrolsneededtocontrol the hazards identified in the hazard analysis as requiring apreventive control. Monitoring, corrective action and verificationprocedures foreachof thepreventivecontrols identifiedmustalsobeincludedinyourplanasappropriatetoensuretheeffectivenessofthecontrols.ArecallplanisalsoarequiredelementofaFoodSafetyPlanwhenahazardrequiringapreventivecontrolisidentified. ouarealsorequiredtomaintainimplementationrecordstodocumentthatyouhaveimplementedyourFoodSafetyPlan.

BecauseyourFoodSafetyPlanwillbeusedorreviewedbyregulators,employees,auditors,customersandpotentiallyconsultants,itmayalsobeusefultoincludeabriefdescriptionofyourfacilityorcompanyalongwithalistofyourFoodSafetyTeammembers,aproductdescription,aprocess flow diagram and a process description to help peopleunderstandthestructureoftheplan.Thiscourseincludestheseoptionalelements in the Food Safety Plan example to help class participantsvisualize the hypothetical operation and resulting documentationexamples. The remainder of the course goes into more detail on theelementsofaneffectiveFoodSafetyPlan.

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Examples of Outbreaks and Recalls

oumaywonder“What’sinitforme ”whenyouconsiderwhatitwilltaketodevelopyourFoodSafetyPlan.Therearenumerousoutbreakand recall examples that illustrate theneed for controls topreventillness,aswellas thebenefitofhavinganeffectiveandoperationalplantoavoidbeinginvolvedinanoutbreakorrecall.Hereareafewexamples.

Peanutbutteristypicallyasafeproductbecauseeffectiveroastingofpeanuts can destroy potential pathogens, such as Salmonella.However, an extensive outbreak in the U.S. associated withcommercially‐used peanut products illustrates the importance ofprocess validation, sanitation controls and supplier controls. Theoutbreakinvestigationfoundthatthepeanutroastingprocesshadnotbeenvalidatedsoitwasnotknownhoweffectivethiscontrolmeasurewas.Further,Salmonellawas found in theprocessingenvironment,which suggests the environmentwas apotential sourceof productrecontaminationandthatsanitationcontrolswerenotadequate.Theincident involvedhundredsof companies thathadused thepeanutingredientsintheirproductswithoutanadditionalkillstep.Asupply‐chainprogram,includingdeterminingthatanypathogenkillstephasbeen validated and that the supplier has controls to preventrecontamination,isanotherimportantpreventivecontroltoincludein a robust food safety system.Together, thesepreventive controlscould have prevented or minimized the size of this incident andassociatedrecalls.

Another example involves a botulism outbreak that occurred inEngland in 1 8 . The manufacturer of the hazelnut conserveingredientfortheyogurtusedaprocessthatwassimilartothatusedforfruitproducts.BecausefruitshavealowerpHthanhazelnuts,the

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processwasnotadequatetokillC.botulinumsporesandtheformulawas not adequate to control growth of C. botulinum when theingredient was held at room temperature. Process validation orstorage of the ingredient at refrigeration temperatures may haveprevented the issue.Understanding supplier capabilities is anotherimportant lesson from this outbreak – the hazelnut conservemanufacturer did not understand that their new product requiredmorestringentcontrols.Anappropriatesupply‐chainprogramcouldhaveidentifiedthisshortcomingandaddressedtheissuebeforetheyogurt manufacturer used the hazelnut conserve that had beeninadequatelyprocessed.

AvoidingorminimizingthepotentialforarecallisanotherbenefitofhavingarobustFoodSafetyPlan.AllergenrecallsareresponsibleforatleastathirdoffoodsafetyrecallsforFDAregulatedfoodproducts(SeeAdditionalReadingattheendofthechapter).Therootcauseformostoftheserecallsisnotdeclaringthepresenceofthefoodallergenonthelabel.Chapter10:FoodAllergenPreventiveControlsprovidesmoreinformationonhowtocontrolthisfoodsafetyhazard.

Contamination of food products typically comes from one of threedifferent sources – 1) ingredients, 2) the processing environment,includingequipmentor3)people.ThisisdiscussedfurtherinChapter4:BiologicalFoodSafetyHazardsandChapter5:Chemical,PhysicalandEconomicallyMotivatedHazards.

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Principles Applied to Build a Food Safety Plan

Developing a Food Safety Plan, including determining wherepreventivecontrolsareneeded,involvesasystematicprocessbasedon science to help ensure the safety of the product. It starts withhazardanalysis(coveredinChapter8),whichisintendedtoidentifyhazardsrequiringapreventivecontrol–inotherwords,theonesthatmatter most for food safety. When these hazards are known,preventive controls that are essential to prevent the hazard fromcausing illness or injury are identified. As previously discussed,preventivecontrolsmayincludeprocesspreventivecontrols,allergenpreventive controls, sanitation preventive controls, supply‐chainpreventivecontrolsorotherpreventivecontrolsthatyoudetermineare essential for your product. Once preventive controls areidentified,youneedtodeterminerelevantparametersthatdefinetheconditions that must be met to effectively manage the hazard.Monitoring provides documentation that demonstrates theseconditionsaremet.Correctiveactionsorcorrectionsarepredefinedto enable swift action when things go wrong, thus preventingexpansionofafoodsafetyissue.Whenthingsgowrong,youalsohavetoaskifitwasbecauseahazardwasoverlooked(inwhichcaseyoumustadjust thehazardanalysis),or ifapreventivecontrolwasnotproperlyidentifiedorimplemented.Alloftheaboveisrecordedandverifiedtoensurethesystemisoperatingasintendedandtoprovidearecordforothers(e.g.,inspectors,auditors,management)toshowthatthisisthecase.

Someelementsofapreventivecontrolssystemalsorequirevalidationtodemonstratethatthecontrolsactuallywork.Thisactivitymaybeless rigorous for some preventive controls than others. Thesedifferenceswillbecomemoreapparentaswegothroughthecourse.

If you currently have a HACCP plan, it likely will be the part of your Food Safety Plan that addresses hazard analysis and process preventive controls (see Chapters 8 and 9). The hazard analysis may need adjustments to identify allergen, sanitation, supply‐chain and potentially other preventive controls in addition to those addressed in a traditional HACCP plan.

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Scope of the Food Safety Plan

FoodSafetyPlansarespecific toa facility,withpreventivecontrolsspecifictoafoodproductandprocess.Itispossibletogroupproductsthat have the same hazards and controls in one Food Safety Planprovided and differences are clearly identified. Some operationschoose to organize Food Safety Plans around unit operations inproduction(e.g.,makingablendthatisusedinseveralproducts)toreduceoverlaporavoidinconsistency.TheorganizationofyourFoodSafetyPlanisuptoyou.

IndefiningthescopeoftheFoodSafetyPlan,youshould:x determine the specific product(s) and process(es) that the

FoodSafetyPlanwilladdress,definethepartofthefoodchainto be considered (e.g., products sold to retail may havedifferent considerations than those sold to foodservice, tomanufacturersordirectlytotheconsumer),and

x address biological, chemical (including radiological) andphysicalhazardsassociatedwiththeabove.

Thescopeof theFoodSafetyPlanmaybe influencedbyregulatoryrequirementsorspecificrequirementsinstitutedbyacustomer.

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Food Safety Plan Example

ThespecificformatofaFoodSafetyPlanisnotdefined.Eachfacilitycan organize the required information in amanner that suits theirsystems,theneedsoftheiremployees,theneedsoftheircustomersandtherequirementsoftheregulation.Theimportantthingistohaveaplanthat iseasytounderstand, implementandmanage; that it iskeptuptodate;andthatitisorganizedandaccessibleforinspection.ThefollowingisanexampleofhowaFoodSafetyPlanmightbesetup, using a notebook. Note that there is no requirement that allcomponentsofaFoodSafetyPlanevenbeinanotebook–wearejustusingthisasamodel.

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Thiscourse isorganizedaroundbuildingaFoodSafetyPlan. Inourexample,weuse the fivemain sectionsor tabs for theFoodSafetyPlan,includingbackgroundinformation,hazardanalysis,preventivecontrols,recallplanandimplementationrecords.

TheinformationbehindtheBackgroundInformationtabiscoveredinChapter 6: Preliminary Steps in Developing a Food Safety Plan.Backgroundinformationisnotrequiredbyregulations,butprovidesa useful framework for organizing the Food Safety Plan and forexplainingtheplantoothers.Anything includedaspartof theplanmaybesubjecttoregulatoryaccessandreview.Abriefdescriptionofthefacilityorcompanymaybeincluded.

Listingmembersofthefoodsafetyteam,alongwithrequiredrecordsontraining,couldbeincludedinthissection.Twotypesoftrainingarerequiredbytheregulation:1)foodhygieneandfoodsafetytraining,asappropriatetoanindividual’sdutiesand2)training,ifapplicable,forapreventivecontrolsqualifiedindividual.

Theproductdescriptionsectionhelpspeopleunderstandimportantelementsoftheproductthatmayimpactfoodsafety.AnaccurateflowdiagramisusefultoensurethatallstepsoftheprocessareevaluatedtoidentifyfoodsafetyhazardsanditservesasausefulorganizationformatfortherequiredwrittenFoodSafetyPlan.Finally,theprocessdescription could provide information needed to fully understandhowtheproductismade.Thiscanbehelpfultothosewhoarelookingat the plan to understand, for example, the types of preventivecontrols applied. A facility can use other documents tomeet thesegoals,ifthatworksfortheirsystem.

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The hazard analysis drives decision making on which hazardsrequiringapreventive control.Thus, thehazardanalysis forms thebasisforotherrequiredelementsintheplan.Carefulanalysisofthehazardsthatmayberelevantforyourproductwillhelpyoutofocusthecontrolsonwhatmattersmost.SeeChapter8:HazardAnalysisandPreventiveControlDetermination.

ThePreventiveControlssectiondescribestheessentialcontrolsthatensuresafeproductisproduced.Therequiredpreventivecontrolsfora specific product are determined through the hazard analysisprocess,whichconsidersthenatureofthepreventivecontrolanditsroleinyourfacility’sfoodsafetysystem.Processpreventivecontrolsare discussed in Chapter . Food allergen preventive controls arecovered in Chapter 10, and sanitation preventive controls are

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discussed in Chapter 11. Supply‐chain preventive controls includesupplierapprovalandverificationactivitiesforingredientsandrawmaterials thathavehazards forwhich thecontrol isappliedby thesupplier. These ingredients are identified through hazard analysis.Chapter 12: Supply‐chain Program discusses supplier relatedactivities.

Insomecasestheremaybeothercontrolsusedbyafacilityaspartoftheirfoodsafetysystem,suchastransportationcontrols,whichwouldalsobeincludedhere.

A recall plandescribes, aheadof time,what todowhen somethinggoeswrongandtheproductisincommerce.Theformatthatyouusecanvaryconsiderably.Forexample,youmaywantatotallyseparaterecallplannotebookbutitwouldstillbeconsideredpartoftheFoodSafetyPlan.

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The Implementation Procedures tab includes other informationrequired to support your plan. Thismay include validation studiesthat demonstrate that the preventive controls you selected areactuallyeffectiveincontrollingtheidentifiedhazards.Proceduresforand records of monitoring, corrective actions or corrections, andverificationactivitiesmayalsoberequired todemonstrate that thefood safety system was operated as planned on an ongoing basis.ExampleformscouldalsobeincludedinaFoodSafetyPlannotebook.Theactual required records couldbe in a separatenotebook, a filecabinet,acomputerorwhateverformatworksforyourorganization.

In summary, the Food Safety Plan is a written document that isspecifictothefacility.Itmustcontainahazardanalysisandseparateplansorprogramsthataddressprocesspreventivecontrols,allergen

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preventive controls, sanitation preventive controls, supply‐chainprograms,andotherpreventivecontrolsdeterminedtobenecessarythroughthehazardanalysisprocess.Itmustalsocontainarecallplanfor food where a hazard requiring a preventive control has beenidentified.ThereisnorequiredformatforthesedocumentsorfortheFoodSafetyPlanitself.Somefacilitiesmaycombinedifferentsections;somemayseparatethem.ThereisnorequirementthatallpartsoftheFoodSafetyPlanbelocatedinoneplace.

TheimportantpointisthatthewholeFoodSafetyPlanisorganizedinawaythatidentifieshazardsrequiringapreventivecontrolsothat1)thehazards are effectivelymanagedand2) the facilityhas recordsthat demonstrate these preventive controls are in place and beingimplemented. These documents should be organized and easilyretrievablewhenneeded,e.g.,forinspectionsoraudits.

EachoftheelementsofaFoodSafetyPlanisdiscussedinsubsequentchapters,usingexamplesfromahypotheticalfoodoperation.

Additional Reading Centers for Disease Control and Prevention (CDC). 2010. Multistate outbreak of

Salmonella Typhimurium infections linked topeanutbutter,2008‐200 (FinalUpdate).

FoodandDrugAdministration(FDA).200 .Peanutproductsrecall.Gendel,S.M.,J. hu,N.Nolan,andK.Gombas.2014.LearningfromFDAfoodallergen

recallsandreportablefoods.FoodSafetyMagazineApril/May2014.O’Mahony,M.,E.Mitchell,R,J.Gilbert,etal.1 0.Anoutbreakoffoodbornebotulism

associatedwithcontaminatedhazelnutyoghurt.Epidemiol.Infect.104:38 ‐3 5.

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CHAPTER 3. Good Manufacturing Practices and Other Prerequisite Programs

TheFoodSafetyPlanisnotastand‐aloneprogram,butratherpartofalargerfoodsafetysystem.Thefoundationalprogramsthatarepartof the food safety system are frequently termed prerequisiteprograms.ThetermwascoinedtoindicatethattheyshouldbeinplacebeforeHACCP‐basedsystemsareimplementedinordertoeffectivelymanage risk from foodborne hazards. The Current GoodManufacturingPractice(GMP)regulationsaddressrequirementsformanyprerequisiteprograms.Thereareotherprogramsthatarelikelyto apply to most facilities, such as supplier and manufacturingspecifications.

Inthischapteryouwilllearnthedefinitionofprerequisiteprogramsand their importance in a food safety system.AnoverviewofGMPrequirements is provided; however, further reading or training isimportant to ensure that you understand these foundationalprogramsandtheregulatoryrequirements ouwillalsolearnaboutotherprerequisiteprogramsthatmaybeimportantforyourfacility.

Prerequisite programs provide the basic environmental andoperating conditions thatarenecessary to support theFoodSafetyPlanandinsomecasestheseprogramswillbepartoftheFoodSafetyPlan.Manyoftheseprogramsarerequiredbyregulation(e.g.,GMPs).Thespecificprerequisiteprogramsrequiredmayvarydependingon

IMPORTANT It is assumed that course participants are familiar with basic Good Manufacturing Practices, thus this chapter provides only an overview. Compliance with GMPs is mandatory. See “Additional Reading” for additional resources.

Definitions: Prerequisite program: Procedures, including Good Manufacturing Practices (GMPs) that provide the basic environmental and operating conditions necessary to support the Food Safety Plan. Food safety system: The outcome of implementing the Food Safety Plan and its supporting elements.

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the typeof foodproducedand the facilitywhere it isprocessedorheld.Somepeopleuse the termsprerequisiteprogram,GMP,cGMP(“c” stands for current), “good hygienic practice” and “sanitationstandard operating procedures” interchangeably. The importantthingtorememberisthatthesearefoundationalprogramsincludedinanoverall foodsafetysystem.Withouttheseprograms, theFoodSafety Plan may not successfully prevent food safety issues.RememberthattheFoodSafetyPlanfocusesonwhatmattersmosttoensurethesafetyofthefoodbeingproduced.

Good Manufacturing Practices

GMPs are federal regulations that apply to all facilities thatmanufacture,process,packorholdFDA‐regulatedfood.GMPsarethebasis for determiningwhether food products have been processedunder sanitary conditions. They outline the minimum sanitarystandards that a food processing facility must meet, includingpersonnel,plantandgrounds,sanitaryoperations,sanitaryfacilitiesand controls, equipment and utensils, processes and controls, andwarehousing and distribution. They also provide for defect actionlevels for natural or unavoidable defects that at low levels are nothazardoustohealth.TheremaybesomeinstanceswhereaspecificGMP task is so important to the safety of the product that it isdesignated as a preventive control in a Food Safety Plan. This isdetermined during hazard analysis andmost likely would occur ifthere are cross‐contamination (in a ready‐to‐eat food) or allergencross‐contactissuesthatneedtobeaddressedinwrittensanitationor allergen preventive controls. Chapter 8: Hazard Analysis andPreventiveControlDeterminationcoversthisselectionprocess.ThischapterfocusesonbasicGMPrequirements.

TheGMPregulationsdonotrequirewrittenprocedures,monitoringor record‐keeping (except for training records); however, they are

This is not a comprehensive discussion of GMP requirements. Certain regulatory requirements are addressed in Chapter 16: Regulation Overview – cGMP and Hazard Analysis and Risk‐based Preventive Controls for Human Food. Regulations are provided in 21 CFR 117 Subpart B in Appendix 1.

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recommendedaspartofa facility’sStandardOperatingProcedures(SOPs) to manage the GMPs and document the results of theseimportantprograms.Thiscanbeveryhelpfultolimittheamountofproductthatmaybesubjecttocorrectiveactionsorrecallswhenanincidentoccurs.Forexample,productmadefromcleanuptocleanup,as reflected in records, defines impacted product for some recalls.WrittenSOPsarealsohelpfulforemployeetraining.TherestofthismodulehighlightsGMPsthatarebasictomakingsurethatproductsareprocessedundersanitaryconditions.

Employee education and training is an important prerequisiteprogram. Employee training must cover cleanliness, healthrequirements, how to perform their job and how their work canimpact the safety of product. This employee training must bedocumented. Supervision and setting a good example is also animportantpartofthesystem.

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Personnel

SelectedGMPsrelatedtopersonnelpracticesare listedontheslideabove. While we will not go into detail on each of these, a fewcommentsregardingpersonnelarewarranted.

Food handlers with vomiting, diarrhea, jaundice, sore throat withfever,woundsoropen lesions couldbea sourceofmicrobiologicalcontaminationthatcouldleadtofoodborneillness. ourproceduresandpracticesmustmakesurethatsickpeoplearenotaroundfood,andemployeesmustreceivetrainingonthis.

People can also carry potential contaminants into the processingenvironment. Clothingmust be clean. Uniforms, smocks, dedicatedfootwear, color coding and other clothing options should beconsidereddependingupontheneedsoftheoperation.

Properhandwashing(andhandsanitizingwhenhandlingready‐to‐eat foods) is essential to prevent direct contamination, cross‐contaminationandallergencross‐contact.Thisshouldbedoneeachtimeemployeesareawayfromtheworkstation.

Direct contamination – transfer of human pathogens, e.g. after using the restroom Cross‐contamination – Unintentional transfer of a pathogen from a food or surface to another food or surface. Allergen cross‐contact – Unintentional incorporation of a food allergen into a food.

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Plant and Grounds

GMPslistedabovefortheplantandgroundshelptoensurethatthebuildingsandstructuresaresuitable for food‐productionpurposes,and to reduce the potential for pathogen recontamination. Forexample, make sure that the grounds outside the food facility areclean,thatthereisnostandingwaterandthatwasteiscollectedanddisposedoffrequently.Insidethefacilityprovideadequatespaceandproper separation for operations (e.g., between cooked and rawproduct and between food with different allergen profiles, ifapplicable).Also,makesurethatwalls,floorsandceilingsareingoodrepair. It isalso important toensurethatcondensatedoesnotdripontoin‐processproduct, thatthereisadequate lightforoperations,andthatanyglassisguardedagainstbreakage.

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Sanitary Operations

TheseGMPscoverspecificoperationsneededtokeepaplantingoodsanitary condition. Making sure that the food facility is in goodcondition and that any cleaning or storage of chemicals do notcontribute to product contamination are important for all foodfacilities.Aspestscanbevectors forcontamination, theyshouldbepreventedfromenteringthefacility.Food‐contactsurfacesneedtobecleanedandsanitizedasoftenasnecessarytoensuretheyarenotasourceofcontamination.Abriefdiscussionoftheboldprovisionsontheslideforsanitaryoperationsfollows.

Toxic Chemical Storage Certain potentially toxic chemicals are essential for effective plantoperations.Onlycleaningandsanitizingchemicals,laboratorytestingchemicals, and chemicals needed for plant and equipmentmaintenance(e.g.,lubricants)maybeusedorstoredinaplantwherefood is processed or exposed. These chemicals must be properlylabeled,usedandstoredinamannerthatprotectsfood,food‐contactsurfaces and packaging material from contamination. Store toxicchemicalsinasecuredareawithlimitedaccess,andseparatedfromfoodprocessingareasandareaswherefoodandpackagingmaterialsarestored.Followthelabelinstructionsforthesechemicalstoensuresafeapplication.

Precautions are necessary for application of insecticides androdenticides. This frequently requires application by a licensedoperator.Thesetoxiccompoundsaregenerallyusedonlyoutsideofthe processing facility unless special precautions are taken. Forexample, thorough cleaning of all food‐contact surfaces afterapplicationwouldbenecessaryifinsecticideswereusedtotreataninternalinfestation.

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Pest Control Pests,suchasrodents,birds,insects,amphibians,reptiles,andferalordomesticanimalsmustbeexcludedorcontrolledinallareasofafoodprocessingorfoodstoragefacility.Thepresenceofpestscanimpactoverall sanitation of a facility so it is important ensure theeffectivenessofpestcontrol.Evenifpestcontroliscontractedtoanoutsidecompany,thefacilitymustassurethattherearenopestsinthefacility.Takemeasurestoexcludepests(e.g.,eliminateholesthatallow entry), and remove vegetation or structures that attract orprovide a harborage for pests. Proper waste removal reduces theavailabilityofafoodsourceorharboragethatcanattractpests.

Sanitation of Food‐contact Surfaces

The Preventive Controls for Human Food regulation requiresdocumentation of sanitation controls for hazards requiring apreventive control in the Food Safety Plan. Only those sanitationproceduresthataddresshazardsrequiringapreventivecontrol(e.g.,sanitationtoaddressenvironmentalpathogensifrelevant)mustbedocumentedinaFoodSafetyPlan.ThisisdiscussedfurtherinChapter11:SanitationPreventiveControls.Adequatecleaningandsanitizingproceduresandfrequenciesmustbeestablishedforallfood‐contactsurfaces, including equipment, utensils and food containers.Glovesanduniformsthatcontactfoodmayalsobeincludedinthiscategory.Suggestedfrequenciesforcleaningandsanitizingincludebeforeuse,afterprocessinginterruptionsandasnecessarytopreventpathogengrowth.

Different methods of cleaning may be relevant in different plantenvironments. Allergen removal requires cleaning but not use ofsanitizers–sanitizingisnotintendedtohaveanimpactonallergens.Useofwater indryprocessing areas is discouragedbecause it caninfiltrate cracks, crevices and difficult to clean areas, establishing

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potential harborage sites for environmental pathogens. Wetprocessingenvironmentstypicallyusedetergentandpotablewaterata suitable temperature for cleaning, followed by sanitizing with asanitizerthatisregisteredforfood‐contactsurfaceapplications,suchas chlorine‐, quaternary ammonium‐ or iodine‐based compounds.Follow manufacturer’s use instructions to ensure efficacy andregulatorycompliance.

Sanitation of Non‐food‐contact Surfaces Asdiscussedabove,sanitationofnon‐food‐contactsurfacesisneededinmost facilities to eliminate potential food sources for pests. Forfacilities that make ready‐to‐eat products that are exposed to theenvironment prior to packaging, cleaning and sanitizing of certainnon‐food‐contactsurfacesmaybeincludedasasanitationpreventivecontrol inaFoodSafetyPlan tominimize thepotential for finishedproduct contamination with environmental pathogens. This isdiscussed further in Chapter 11: Sanitation Preventive Controls.Additional information on general cleaning and sanitation isdiscussedinAppendix5:SanitationBasics,includinginformationonpotential spread of contamination by inappropriate use of highpressurehosesthroughcreationofaerosols.

Sanitary Facilities and Controls

Sanitary facilities and controls include thewater supply, plumbing,sewage disposal, toilet facilities, hand‐washing facilities, and trashand waste disposal. A brief discussion of the water supply andplumbing,aswellastoiletandhand‐washingfacilities,follows.

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Water Supply and Plumbing

Water and ice that contacts food, food‐contact surfaces and food‐packagingmaterialmustbeofsafeandadequatesanitaryquality.

x Thesourceofwaterandtheplumbingsystemthatconveysittothebuildingmustprovideasafesupply.Inmanyregions,thewatertreatmentauthorityisresponsibleforascertainingthesafetyofthewatersourceandconveyancetothebuilding.In these situations, a company’s documentation shouldincludeannualwaterqualitytestsfromthewaterauthority.Facilitiesusingprivatewatersystems(e.g.,wells)aredirectlyresponsible for adequatemonitoring and documentation ofthesafetyofthewatersource.Municipalitiesinmanyregionscanprovideguidance.

x Ice must be made with potable water and protected fromcontamination with the same care used for food when icecontactsfood(orfood‐contactsurfaces).

x Thetemperatureandpressureofwatermustbesuitableforthefacility’suse.Forexample,hotwatermaybeneededforeffectivecleaningandsanitizing.

x Toensurewater is safe, cross‐connectionsbetweenpotableandnon‐potablewaterlinesmustbeprevented.Theremustbe no cross‐connection or backflow potential between thewatersupplyandpipingforwastewaterorsewage.

Developed regions typically have mature water safety programs,while developing regions may not have uniform delivery of safedrinkingwater.Potentialhazardsandcontrolsmustbeconsideredforthoseregions.

Definition Potable water: Water that meets the standards for drinking purposes of the State or local authority having jurisdiction, or water that meets the standards prescribed by the U.S. Environmental Protection Agency’s National Primary Drinking Water Regulations (40 CFR 141).

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Hand Washing, Hand Sanitizing and Toilet Facilities

Employees,eventhosewhoarehealthy,cancarryandshedhumanpathogensthatcanbetransmittedthroughfood,thushandwashingand sanitary toilet facilities are essential for food safety. Eachestablishment must provide hand‐washing facilities designed toensurethatanemployee’shandsarenotasourceofcontaminationoffood,food‐contactsurfacesorfood‐packagingmaterials,byprovidingfacilitiesthatareadequate,convenient,andfurnishrunningwateratasuitabletemperature.

Hand washing and, where appropriate, hand sanitizing facilitiesshouldbeateachlocationwheregoodsanitarypracticerequirestheiruse. Effective hand hygiene training should be accompanied byavailablehandwashingsuppliesthatremovefoodsoilsfromhands;e.g.,soap,runningwater.Handwashingsignsareusefulreminders.Wateratacomfortabletemperaturemustbeavailableandsingle‐usetowels or suitable drying devices should be provided to preventrecontamination.Wethandsaremorepronetospreadcontaminationthanaredryhands.

Anadequatesewagedisposalsystemisrequired.Readilyaccessibletoiletfacilitiesmustbemaintainedinsanitaryconditionandnotbeasource of contamination. Toilet facilities should have self‐closingdoors that do not open into processing areas. Additionally, toiletfacilities should be in good repair (e.g., not leaking) and should beproperly supplied with personal hygiene products, including handwashingsupplies.

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Equipment and Utensils

Equipment, including utensils, must be designed to be adequatelycleanedandmaintained ina sanitary condition.Forexample, food‐contact surfacesmust bemade of corrosion resistant andnontoxicmaterialstopreventadulteration.Seamsshouldhavesmoothweldstoensurecleanability.Also,compressedairintroducedintofoodmustbe treated so that it does not contain adulterants and be properlyfilteredtopreventparticlesfromgettingintofood.

Coolingequipment, suchas freezers and coolersmustbe equippedwithtemperatureindicatingdevices,suchasthermometersorchartrecorders.Automatictemperaturecontroloranalarmsystemhelpsto ensure that the proper temperatures are maintained.Thermometersandsimilarequipmentmustbeaccurate(closetothecorrect measure), precise (appropriately narrow r range) andmaintained.

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Processes and Controls

Processes and controls used for food must ensure that the foodremains suitable for human consumption. This provision coversgeneral and more specific requirements for raw materials,ingredients, and manufacturing operations. Take adequateprecautionstoensurethatproceduresdonotcontributetoallergencross‐contact or contamination from any source, andminimize thepotential formicrobialgrowth.When food isadulterated, itusuallymustberejected.FDAmayallowthefoodtobetreatedorprocessedtoeliminate contamination (see21CFR117.80(a)(6)).Appropriatequalitycontrolproceduresarerequiredtoassuresuccess.Sometasksmayrequirespecialattention.Forexample,overallsanitationofthefacilitymustbesupervisedbyqualifiedindividualswhounderstandwhat it takes tomaintainappropriate sanitary conditions in a foodfacility.

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Raw Materials and Ingredients

Raw materials must be free from pests, extraneous material (e.g.,string,plastic,metal,etc.),andundesirablemicroorganisms. ouareresponsible for assuring this using whatever techniques areappropriateforthematerialandyoursourceofsupply.Rawmaterialsmustbeinspectedforsuitability.Theymustbestoredandhandledtoprevent contamination (e.g., properly packaged) and deterioration(e.g., appropriate time, temperature andhumidity conditions).Thisalsoappliestothawing.Ifyouuserework,ensurethatitisproperlyidentified, stored and handled to prevent contamination, allergencross‐contactanddeterioration.

Manufacturing Operations

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All manufacturing operations must be conducted to minimizemicrobial growth. Pasteurizing, freezing and refrigerating are foodprocessingmethodsthatmaybeusedtopreventspoilageandensuresafetyofcertain foodproducts.Theextent towhich theseareuseddependson theparticularproductand itsdistribution.Whenused,theseprocessesmustbedoneinamannerthatensurestheconditionsareadequate tomaintainproductsafetyandpreventdeterioration,including use of time and temperature combinations that killpathogens of concern (for pasteurization) and that prevent thegrowth of microorganisms during cooling in refrigeration andfreezingprocesses.Rapidcoolingorfurtherprocessingwithoutdelayofblanchedfoodsisnecessarytopreventmicrobialgrowth.Certainbacteria,calledthermophiles(thermo heat,phile loving),cangrowathottemperatures.Minimizethermophilicgrowththroughpropertemperatureandtimelycleaning.Certainmoistfoodssuchasbatters,breading, sauces, gravies, and stuffing can support rapid growthofmicroorganisms. Protect these from contamination through goodquality ingredients,heat treatment, time/temperaturecontrols,andphysicalprotectionsuchascovers.Conversely,dryfoodsthatdependonreducedwateractivitytocontrolmicrobialgrowth(discussedinChapter 4: Biological Food Safety Hazards) must have parameters(e.g.,solublesolids/waterratioorwateractivity)monitoredtoassurethat growth is controlled, and must be protected from moisturepickup. Factors that influence microbial growth are discussed inChapter4:BiologicalFoodSafetyHazards.

Clean and sanitize equipment, utensils and finished productcontainers as necessary to ensure sanitary conditions. This mayrequire disassembly of equipment to facilitate cleaning. Ice is acommon ingredient for many operations. If made in‐house, usepotablewaterandproduceitinasanitarymanner.Icemachines,likeother food processing equipment, must be cleaned and sanitizedperiodically.

Finishedorin‐processfoodmustbeprotectedfromcontaminationbyrawmaterialsorrefuse.Thisincludesexposedfoodonconveyorsintheambientenvironment,aswellas in freezersandcoolers.Useofsieves, traps,magnetsandmetaldetectorscanbeuseful topreventinclusionofmetalandextraneousmaterial,ortodetectmetalifsuchcontaminationdoesoccur.Destructionandreconditioningoperationsshould not serve as sources of contamination and methods usedshouldbeshowntobeeffective.

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Warehousing and Distribution

Sanitaryconditionsapplynotonlytomanufacturingareas,butalsotowarehousinganddistribution.Microbialgrowthmustbeprevented.Allergencross‐contactmustbeprevented.GMPsrequirethatfoodisprotected from biological, chemical (including radiological) andphysicalhazards,aswellasfromdeteriorationduringwarehousinganddistribution.

Human Food or By‐products sent to Animal Food

Foodcompaniesoftensendunusablefoodorby‐productmaterialstotheanimalfoodsupplychain.Foodmaybeunsalabletohumansforqualityorsafetyreasons,butcouldbesafe(ormadesafe)foranimalsto consume. By‐productsmight be sent to animal feed converters,manufacturersorwholesalers;ordirectly toanimalproducers that

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may feed itdirectly toanimalsor, ifnecessary,process the food tomitigateanyhazards.

Humanfoodandby‐productsheldandsenttotheanimalfoodsupplychain in general are not subject to the requirements for hazardanalysis and risk‐based preventive controls for animals, but mustcomplywithspecificholdinganddistributionGMPstokeeptheby‐product safe (21 CFR 117. 5 and 21 CFR 507.28). For example,containersused toholdanimal foodbeforedistributionneed tobeconstructed of appropriate material, cleaned and maintained topreventthemfromcontaminatingtheby‐products.

By‐productsmustalsobeheldinawaythatpreventscontaminationfrom trash and garbage (e.g.; employee lunches, maintenancedepartmentdebris).Useof color‐codedcontainers todesignate thecontents(e.g.,fortrashversusforhumanfoodby‐productsgoingtothe animal food supply chain) may be useful. Additionally, by‐productsmust be labeled on the container or shipping documentswith the common or usual name, such as “cereal food fines” forparticles of breakfast cereals obtained as a by‐product of theirprocessing(SeeAAFCOinAdditionalReading).

Notethatifahumanfoodmanufactureralsoprocessestheby‐productmaterials(e.g.,drying,pelleting,grinding),theymustcomplywiththePreventiveControls forAnimalFood regulation in 21CFRPart 507.ThesecompaniesshouldconsiderparticipatingintheFSPCAcourseforanimalfood.

Defect Action Levels

Even when produced under GMPs, some foods contain natural orunavoidabledefectsthatdonotpresentahazardtohealth.TheFDAsettheseactionlevelsbecauseitiseconomicallyimpracticaltogrow,harvest or process raw products that are totally free of non‐

Definition Defect action level: A level of a non‐hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product “adulterated” and subject to enforcement action under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act. ‐ 21 CFR 117.3

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hazardous,naturallyoccurring,unavoidabledefects.FDAestablishesmaximum levels for these defects and will use these levels whendecidingwhethertorecommendregulatoryaction.Themanufacturerisstillresponsibleformanagingthesedefects,andtryingtokeepthemtothelowestlevelcurrentlyfeasible.Forexample,afewpitfragmentsin pitted dates, olives and prunes may be considered unavoidableevenunderGMPs.Mixingoffoodcontainingdefectsabovethedefectactionlevelwithanotherlotoffoodwithlowlevelsisnotpermitted–theentirebatchwouldbeconsideredadulteratedregardlessof thelevelpresent.

Other Prerequisite Programs

In addition to GMPs, other common prerequisite programs includehygienic zoning, supplier and product specifications, preventivemaintenance, special signage (e.g., allergen icons) or color codedequipment (e.g., a special color forwastematerial containers) andotherprogramsspecifictotheoperation.

Hygienic Zoning Hygieniczoningisusefultoreducethepotentialspreadofpathogensin facilities that manufacture ready‐to‐eat (RTE) products. Forexample,areasofthefacilitythathandletherawingredient(e.g.,rawpeanuts)mayhavelessstringentexpectationsforhygienethanthosehandling the RTE product (e.g., roasted peanuts). oning typicallyinvolves separation of, for example, cooked product from rawproduct, andmay include different uniforms for “cooked side” and“rawside”employees,dedicatedequipment(e.g.,cartsor fork lifts)for different zones, traffic flow and air flow considerations, etc.HygieniczoningisdiscussedfurtherinAppendix6:Hygienic oningand Environmental Monitoring Supplemental Information. Someelements of hygienic zoning may be a preventive control asdeterminedthroughthehazardanalysisprocess.

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Purchasing and Manufacturing Specifications Writtenspecificationsfortheproductsyouproduceandtheprocessesyouusetomakethem,aswellasingredientandpackagingmaterials,arecommoninbusinesstransactions.Wellwrittenspecificationshelptoensurethatexpectationsareunderstoodbyboththecustomerandthesupplier.

This isparticularly important for ingredients thathaveahistoryofassociationwithfoodbornehazards.Effortsshouldbemadetoknowyoursuppliers, suchas learningabout their facilitiesandpractices,andthesafetyandqualityoftheirproducts.Buyingingredientsontheopen market without knowledge of the supplier’s food safetypracticesorprogramcanaddrisktoyouroperation.

Written ingredient andpackagingmaterial specifications shouldbedevelopedforallsuppliers,andverificationofcompliancewiththosespecifications is recommended for ingredient classes that have ahistoryofcontamination.Adherencetothespecificationiscommonlyconfirmed through the use of a letter of continuing guarantee or acertificate of analysis (COA) that verifies the ingredient or productmeetsspecifications.Chapter4:BiologicalFoodSafetyHazardsandChapter 5: Chemical, Physical and Economically Motivated FoodSafety Hazards review some ingredients that have a history ofoutbreaksassociatedwithspecificfoodbornehazards.

Periodic reviews of the supplier’s product against ingredientspecification requirements should be an element of supply‐chainprograms. Use of a third‐party auditing firm that reviews thesupplier’sfoodsafetyprogramisonewaytoverifythatcontrolsareinplaceatthesupplier.Theextenttowhichcontrolsareusedshouldberisk‐basedandconsistentwithregulatoryrequirements.Chapter12: Supply‐chain Programs provides more detail on requirementswhen hazards requiring a preventive control are addressed by asupplier.

Others Specific to the Operation Some organizations develop detailed procedures that may also beconsidered prerequisite programs. These may include receiving,storage and shipping procedures, labeling and label review,ingredienthandlingpractices,glasscontrol,visitorcontrol, etc.Theimpactoftheseprogramsonfoodsafetycanbeconsideredduringthehazardanalysisprocess.Forexample,labelingfoodsthatcontainfoodallergens is apreventivecontrol thatmustbe included in theFoodSafety Plan, but label review for other information may be aprerequisite program. Similarly, glass control programs may be aprerequisite program for facilities that do not pack in glasscontainers;however,preventivecontrolswouldberequiredifglasscontainersareusedinafacility.

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Other Regulatory Requirements

Finally, thereareanumberof requirements thatareoutsideof thescopeofthePreventiveControlsforHumanFoodregulationandmaynot be related to these regulations.These, however, are regulatoryrequirementsunderotherprogramsandprocessorsshouldbeawareoftheserequirementsastheymayneedtobeincludedintheiroverallfoodsafetyprogram.Forexample,seafoodproductsarenotsubjecttothePreventiveControlsforHumanFoodregulationbutaresubjecttoGMPsandtheseafoodHACCPregulation.

GMPs and Other Prerequisite Programs Summary

GoodManufacturingPracticesandotherprerequisiteprogramsmustbe inplacetoprovideasolid foundationforyourFoodSafetyPlan.

This is not a comprehensive list of other regulations that are outside of the scope of the Preventive Controls for Human Food regulation.

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Theseprogramsestablishthefoundationforeffectivelyimplementingyourfoodsafetysystem.GMPsarerequiredbyregulations,andmostelementsaremanagedasprerequisiteprogramsoutsideofyourFoodSafetyPlan.GMPsareoperationalizedbyworkers,frequentlythroughwrittenSOPs.ThecourseprovidedabriefoverviewofGMPs.BecauseallGMPsarerequired,additionaltrainingorin‐depthreadingoftheGMPregulationsisimportanttoensurethatthespecificrequirementsareaddressed.

This course cannot discuss all prerequisite programs in detail.Depending on the product or business, there may be additionalprogramstoconsiderandimplement.

Additional Reading Links to GMP training and some of the additional references areavailable on the FSPCA websitehttp://www.iit.edu/ifsh/alliance/resources/AmericanMeatInstitute.2003.SanitaryEquipmentDesign.AAFCO (Association of American Feed Control Officials) 2015 Official Publication. Cramer,M.M.2006.FoodPlantSanitation:Design,Maintenance,andGoodManufacturing

Practices.Taylor&Francis.FDA.21CFR117,SubpartB–CurrentGoodManufacturingPracticeGrahamDJ.2006.SnapshotsinSanitaryEquipment:DevelopinganEyeforHygiene.Food

SafetyMagazine.Grocery Manufacturers Association. Equipment Design Checklist for Low Moisture

Foods.Imholte,T.J.andImholte‐Tauscher,T.K.1 .EngineeringforFoodSafetyandSanitation.

2nded.TechnicalInstituteofFoodSafety.InnovationCenterforUSDairy.2012.PathogenControlProgramTools.Marriott,N.G.andGravani,R.B.2010.PrinciplesofFoodSanitation.2010.5thed.Aspen

Publications.NACMCF(NationalAdvisoryCommitteeonMicrobiologicalCriteria forFoods)1 8. J

FoodProt.61( ):1246‐125 .NationalConferenceonInterstateMilkShipments.2013.NCIMSdairyHACCP uestions

andAnswers–PrerequisitePrograms.NationalSeafoodHACCPAlliance.2000.SanitationControlProceduresforProcessingFish

andFisheryProducts,FirstEdition(AvailableinEnglishandSpanish).Pehanich,M.2005.Designingfoodsafetyintoyourplant.FoodProcessingMarch7,2005.United Fresh Produce Association. 2003. Sanitary Equipment Design Buying Guide &

Checklist.

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CHAPTER 4. Biological Food Safety Hazards

IndevelopingormodifyingaFoodSafetyPlan, it is importanttobeaware of the potential hazards that are associated with the foodproducts and processes under consideration. When hazards areunderstood, preventive measures can be implemented to controlthose hazards, thus preventing illness or injury. This chapterintroduces the definition of the term “hazard,” discusses biologicalhazardsthatarecommonlyofconcerninfoodprocessingplantsandfacilities holding food products, and reviews potential controls forbiologicalhazards.

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ThePreventiveControlsforHumanFoodregulationdefineshazardas“any biological, chemical (including radiological), or physical agentthatisreasonablylikelytocauseillnessorinjury.”Biologicalhazardsinclude pathogenic bacteria, viruses and parasites. Chapter 5:Chemical, Physical and Economically Motivated Hazards coverschemical(includingradiological)andphysicalhazardsmentionedinthe definition. Information from this chapter on biological hazardsandChapter5 isuseful forconductingahazardanalysis fora food,which identifies the hazards that require a preventive control. Thehazard analysis process is discussed inChapter 8:HazardAnalysisandPreventiveControlsDetermination.

Itisimportanttounderstandthat,forthepurposesoffoodsafety,theterm“hazard”refersonlytotheconditionsorcontaminantsinfoodthat has the potential to cause illness or injury to people. Manyconditions are highly undesirable in food, such as the presence ofinsects, hair, filth or spoilage. Economic fraud and violations ofregulatoryfoodstandardsareequallyundesirable.Allofthesedefectsshouldbecontrolled in foodprocessing;however,manytimestheyare not directly related to the safety of the product. Unless theseconditionsdirectlyaffectfoodsafety,theyarenotincludedinaFoodSafety Plan. The Preventive Controls for Human Food regulationconsiders decomposition to be a food safety hazardwhenbiogenicaminesorothertoxicsubstancesareproduced.

HowahazardisaddressedinaFoodSafetyPlandependsonboththelikelihood of its occurrence in the absence of its control and theseverity of the illness or injury that would result if the food isconsumed. The difference between a known or reasonablyforeseeable hazard and a hazard requiring a preventive control isexplained in Chapter 8: Hazard Analysis and Preventive Controls

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Determination.Thecurrentchapterprovidesageneraldiscussionofbiologicalhazardsinfoodproducts.

Ausefulsourceofinformationonthehazardsthatmaybepresentindifferent foods is FDA’s Reportable Food Registry (see AdditionalReading). This registry collects information from the food industryandfrompublichealthauthoritiesonfoodsorfeedthatarelikelytocause serious adverse health consequences or death to humans oranimals if they are used. Biological hazards represent the primarycategory of hazards reported through the registry. However,undeclaredallergensinfoodrepresentaboutonethirdofthereports.These are discussed in Chapter 5: Chemical, Physical andEconomicallyMotivatedHazards.

CDC surveillance data include confirmed and suspected foodborne illnesses that are reported by states. These numbers are just the tip of the iceberg and do not include adjustment factors for under reporting.

The CDC estimates that one in six (or 48 million) people get sick from eating food every year in the U.S. and 3000 die.

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TheCenters forDiseaseControl andPrevention (CDC) surveillancedataonfoodbornediseaseoutbreaks(i.e.,twoormorepeoplebecomeill from consuming the same food item) are illustrated above. Thenumberof illnessesreportedis justthe“tipoftheiceberg”becausemanyfoodborneillnessesarenotreportedtoCDC;however,thedataareusefultounderstandthetypesofhazardsthatarelikelytocauseillness.

Biologicalhazards,includingbacteria,virusesandparasites,arethemost frequently reported hazard group associatedwith foodborneillness intheU.S.Chemicalagentsarealsoreported,butasyoucansee, reported numbers are much lower than those for biologicalhazards.Foodallergenreactionsmaynotbecaptured in theseCDCdatabecausean“outbreak”requires2ormorepeopletobeillfromthesamefood–allergenicreactionsaresporadicandlikelyinvolvingonepersonatatime.CDCsurveillancesystemsdonotreportphysicalhazardoutbreaks.

Mostbiologicalhazardsbelongtoagroupoflivinglifeformsthataretoo small to see with the naked eye, called microorganisms.Microorganismsarepresentinair,dirt,water,skin,hair,animalfur,plantsandnumerousothersourceslikesalivaandairexpelledwithcoughs and sneezes. Microorganisms are classified into variousgroupsincludingbacteria,viruses,protozoa,yeastsandmolds.

Prions are the agent responsible for “mad cow disease” (or intechnical terms, bovine spongiform encephalopathy or BSE) andsimilar diseases in other animals including certain types of game.Prions arenot covered in this course, but seeFDA’sBadBugBooklisted in “Additional Reading” formore information if you processgame.

Definition

Pathogen:A microorganism of public health significance. ‐ 21 CFR 117.3 Definitions

In this course, the term is generally used to refer to microorganisms that cause illness through consumption of food.

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Manymicroorganismsarebeneficial.Certainkindsofyeasts,moldsandbacteriahelpmakecheese,sourcream,yogurt,sausage,pickles,sauerkrautandotherfermentedproducts.Particularstrainsofyeastsareusedinmakingbread,beer,wineandotherfermentedproducts.These microorganisms are intentionally added to foods and theycausenoharm.Peoplecomeintocontactwiththousandsofkindsofyeasts,molds,bacteria,virusesandprotozoadailywithoutilleffect.Infact,bacterialivenaturallyonourskin,inournoses,mouthsanddigestivetract.Theyplayanimportantroleindigestingourfoodandarepartofahealthyhumansystem.

Foodbornepathogens,however,maybehazardoustohumansundercertain conditions. Viruses and bacteria are the most commonfoodborne pathogens. Many different types of bacteria can causefoodborne illness. Most foodborne virus outbreaks are caused bynorovirus (typically in foodservice settings), but others, such ashepatitis, are also known. Some molds produce hazardous toxinscalled mycotoxins, which are considered chemical hazards in thiscourse (See Chapter 5: Chemical, Physical and EconomicallyMotivatedFoodSafetyHazards).

Remember that biological hazards can be introduced into a foodproduct from ingredients and other raw materials, from foodprocessing equipment and environments used to make the finalproduct,andfrompeoplehandlingtheproductduringharvestingorprocessing.Understandinghowbiologicalhazardscanbehavewhentheyareintroducedintoafoodcanhelpyoutodeterminehowbesttocontrolthem.

Bacteria, parasites and viruses are different kinds of biological hazards. Control strategies are discussed later.

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Infections and Intoxications

Foodbornepathogensmaycauseillnessinhumansbyeitherinfectionor intoxication after the food is eaten. Foodborne infections arecausedbyconsuminglivepathogensthatgrowinthebody,usuallyintheintestinaltract,andcauseillness.Becausegrowthinthebodyisrequired for an infection, considerable time can pass beforesymptomsoccur–typicallymorethan12hoursandsometimesdaysor even weeks. In other instances, the high numbers of somepathogens release toxins in the intestinal tract; e.g., ClostridiumperfringensandcertainstrainsofBacilluscereus.Thespecificinfectionsymptoms depend on the pathogen and the susceptibility of thepersoneating the food,andcan includenausea,vomiting,diarrhea,and sometimes fever. Illness can sometimes lead to hospitalizationandevendeath.Viruses,parasitesandmanybacteriaofconcern infood cause infections. While viruses and parasites cannot grow infood,preventionofbacterialgrowthisimportantbecausethegreaterthennumberofpathogenspresentinafoodthemorelikelyitisthatsomeonewill become ill.More information on growth is discussedlater in this chapter and in Appendix 4: Foodborne PathogenSupplementaryInformation.

Foodborneintoxicationiscausedbyconsumingtoxinsproducedbyhigh numbers of certain bacteria (e.g., Staphylococcus aureus andcertainstrainsB.cereus)aftertheyhavegrowninthefood.Symptomsfrom foodborne intoxicationusually occurmore rapidly than thosefroma foodborne infection,and illnesscanoccura fewhoursafterconsumption. Prevention of pathogen growth in food preventsfoodborne intoxications. Some toxins arenotdestroyedbyheat, soreheating food that was temperature abused does not necessarilymakeitsafe.

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Manyinfectiousbacteria,suchasSalmonella,canpresentapotentialhazardsimplyduetopresenceinthefoodwhenconsumed,whereasother bacterial pathogens require growth to a level that canmakepeoplesick.Someknowledgeofbacterialpathogensandwhatittakesto create a hazardous condition in food is important for selectingpreventivecontrols.Becauseofthediversityofthefoodsupply,itisreasonabletoassumethatsomepotentiallyhazardousbacteriawillbe present in ingredients and food processing environments. SeeAppendix 4: Foodborne Pathogen Supplementary Information forinformationondifferentfoodbornepathogens,includingsymptoms,andparametersthatcancontrolgrowth.

Foodborne Bacterial Hazard Prevention

Threebasicstrategiescanbeusedtocontrolbacterialpathogensinfood–preventcontamination,killthemandcontrolgrowth.

Prevent Contamination Keeping pathogens out of the food can be accomplished throughpractice of good personal hygiene by food workers, prevention ofcross‐contaminationthrougheffectivesanitationpractices,anduseofasafesupplyofingredientsandotherrawmaterialstominimizetheintroductionofpathogensintothefacilityandthefood.MuchofthisismanagedthroughGMPsdiscussedearlier,likepersonnelpracticesaswellassanitation.GoodAgriculturalPracticesandGoodHusbandryPracticesonfarmsarealsoimportanttominimizecontaminationofingredientscomingfromthefarm.

Recontamination of products after cooking or other antimicrobialtreatments has also caused outbreaks. Because of this, selection ofappropriate preventive controls should consider the potential forbacterial survival and reintroduction after cooking or otherinactivationprocesses.

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Kill Them

Inactivation, killing and elimination are all terms that refer toreducingpathogenstoalevelthatisunlikelytocauseillness.Cookingis frequentlyusedtodestroypathogens;however,othertechniquessuchasirradiation,highpressuretreatments,antimicrobialchemicals(e.g.,sanitizers),acidification,ultrasoundandpulsedlightmayalsobeappliedtofoodortofoodcontactsurfaces.Thesetechniquesmustbevalidatedtothespecificfoodandprocessingconditionstoensurethattheycontrolthepathogensofconcerninthespecificfood.

For example, for cooking to be successful, the foodmust reach anadequate temperature for a long enough time to kill themicroorganisms of concern. Higher temperatures kill faster thanlowertemperatures.Therequiredtemperaturedependsonthefood,the pathogen of concern and the time involved. Safe cookingtemperatures may be established for certain foods (see side bar).Other validated time/temperature combinations may also beappropriate.

Appendix 4: Foodborne Pathogen Supplementary Information provides time and temperature guidance for controlling pathogen growth and toxin formation as well as inactivation of L. monocytogenes. FDA’s model Food Code provides safe cooking time and temperature combinations for a variety of foods (see Additional Reading). FDA’s Dairy Hazards Guide also provides safe cooking temperatures for certain products (see Additional Reading). Other validated time and temperature combinations may also be appropriate for certain foods.

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Bacterial hazards can be classified as sporeformers and non‐sporeformers.Bacterialsporeformersarenotablefortheirabilitytoproducesporesthatcansurviveharshconditionsthatdestroyotherpathogens. In the photo above, the bright ovals are heat resistantBacilluscereussporesandthelarger,darkrodshapedbacteriaareB.cereusinitsvegetativestate.Sporesarenothazardousaslongastheyremaininthesporestate.Unfortunately,sporesareveryresistanttoheat, chemicals and other treatments that would normally killvegetativeformsofbothsporeformersandnon‐sporeformers.Whensporessurviveaprocessingstepdesignedtokillvegetativebacteria,theymaybecomeahazardinthefoodiftheyareexposedtofavorableconditionsthatallowgerminationandgrowthasvegetativecells.Thiscanbeparticularlyseriouswhenaprocessingstephasremovedmostoftheircompetition.Theprocessstepsusedtokillsporesareoftenmuch more severe than those necessary to kill vegetative cellsbecausesporesaremoreresistant.

Somevegetativecellsaremoreresistantthanotherstoinactivationmethods;thus,itisimportanttounderstandthepotentialpathogensofconcerninaspecificfoodandtodemonstrate,throughvalidation(discussed in Chapter 13: Verification and Validation Procedures),that thecontrols thatyouapplyactuallycontrol thesehazards. It isalso important to understand if destroying one type of hazardprovides an opportunity for other hazards to emerge becausecompetitioniseliminated.

Definitions

Spore: A dormant, resistant form of certain bacteria

Vegetative cell: the growing form of bacteria

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Prevent Growth

Keepingmicroorganismsfromgrowingcanbeanimportantcontrolwhentheprocessdoesnotkillpotentialpathogens(e.g.,spores)orwhen productsmay become recontaminated after a lethal process(e.g.,ready‐to‐eatproductsthatareexposedtotheenvironmentaftercooking).Preventinggrowthalsomayreducetheriskof foodbornedisease because some pathogens must grow to a sufficiently highnumber to present a hazardous situation, such as when toxinproductionorahighinfectiousdoseisneededtocauseillness.Time,temperature,thelevelofacidity(pH),availablewater(wateractivity– aW), the right level of oxygen (atmosphere), the presence ofcompetitionbyotherbacteriaandpreservativeusecanallinfluencegrowthofpotentiallyharmfulbacteria.

It can sometimes take bacteria a bit of time to start growing (lagphase),but thenunder favorableconditions they takeoffandgrowrapidlywithonebacteriumdividingintotwo,twointofour,fourintoeight, eight into sixteen and so on (growth phase). Under idealconditions, some bacteria double every 20 minutes; thus onebacteriumcanmultiplytomorethan30,000in5hoursandover16million in eight hours. If relevant, toxin formation usually occursduring exponential growth. Growth continues until they run out ofwhattheyneedtokeepmultiplying(stationaryphase),andthentheycanstartdyingoff (deathphase). Ideally,growthwillbepreventeddue to the nature of the food itself or through application ofpreventivecontrols.

Logarithmic scale

A logarithmic (log) scale is used to plot microbial growth because of the rapid increase in numbers. Simply put, there is a 10‐fold difference between each unit on a log. For example, a log unit of 2 is 10 times more than a log unit of 1; similarly, a log unit of 5 is ten times more than a log unit of 4.

For example, log 3 = 1000 log 4 = 10,000 log 5 = 100,000 etc.

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Factors that Influence Bacterial Growth

Bacteriahavecertainrequirementstoliveandgrow,includingfoodwith their required nutrients, the appropriate temperature, wateravailable inthe food,asuitablepH,therightatmosphereandotherfactors.Ifconditionsarenotfavorableforgrowth,somebacteriadiewhileotherspersistuntiltheirgrowthrequirementsaremet,suchaswaterbeingaddedtoadryenvironment.

Improper holding temperatures for food may allow foodbornebacteriatomultiply.Veryrapidgrowthoffoodbornepathogenscanoccurring between 77q to 104qF (25q to 40qC). The range oftemperature that supports pathogen growth varies considerablydepending on the specific bacterium (see Appendix 4) andcharacteristicsofthefood.Guidelineshavebeendevelopedforhowlongfoodcanbeheldatpotentialgrowthtemperatures.Forexample,coolingmodelshavebeendevelopedforC.perfringensbecauseofthepotential for its rapid growthwhen cooling soups and sauces. Thetemperatureofthefooditselfisofprimaryimportance.Forexample,even if a refrigerator or cooler is at the proper temperature, foodplacedinitmaynotcooldownrapidlyiflargecontainersorinsulatinglayers exist. See Table A4.2 in Appendix 4: Foodborne PathogenSupplementary Information for guidelines on the maximum,cumulativetimeandfoodtemperaturecombinationsforcontrollinggrowthandtoxinformationsforfoodbornepathogenicbacteria.

In general, holding food at temperatures between the properrefrigerationtemperatureforyourproductand135qF(57qC)shouldbeavoided.Thisisthe“dangerzone”atwhichbacterialpathogenscangrow.

The USDA‐ARS Pathogen Modeling Program, available at:

http://pmp.errc.ars.usda.gov/PMPOnline.aspx , and similar models exist to evaluate potential for growth.

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ThepHofafoodisameasureofitsacidityoralkalinity.FoodswithapHlessthan7.0areacidic.ThepHofafoodcanbemeasuredusingapHmeterorpHpaper.FoodswithalowerpH,likevinegarandlemonjuice,ismoreacidicthanthosethathavehigherpH,likemilkandeggs.ApHbelow4.6preventsthegrowthofmanybacterialpathogens,suchasClostridiumbotulinum,whichisadeadlypathogen.However,somepathogenscangrowbelow4.6,dependingonthefood,temperature,and other factors (see Appendix 4: Foodborne PathogenSupplementary Information). For example, Salmonella, the mostcommonbacterialhazardassociatedwithfoodborneillness,hasbeenreported to grow in environments with pH as low as 3.7 underotherwiseoptimumconditions.

Whilea lowpHmaypreventbacterialgrowth,somepathogenscansurvive DonotassumethatalowpHwillnecessarilykillapathogen.

The pH is a measure of acidity. Notice that some foods (e.g., lemons and vinegar) have very low pH values where pathogen growth will not occur. Others (e.g., milk and eggs) have natural pH values where growth is likely if other conditions are favorable.

If the safety of your product depends on pH, you must use a reliable method. FDA methods for measuring pH of acidified foods are found in 21 CFR 114.90 – Methodology.

NOTE: Sometimes addition of other ingredients can change the pH or water activity of a food. Pay attention to this if you use these factors to control growth.

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Allformsofliferequirewatertogrow.Wateractivity(aW)isatermused todescribe theavailabilityofwater (freemoisture) ina food.Purewaterhasawateractivityof1.0.Addingsubstancessuchassalt,sugarandotherfoodingredientscanreducetheavailabilityofwaterformicrobialgrowth.Thinkaboutseawater–differentspeciesthrivein the ocean, than in a freshwater lake. The same is true formicroorganisms.

Many fresh foods have aW values above 0. 6, which supports thegrowthofpathogens.TherearealsomanydryfoodswithaWvaluesbelow0.6,whichinhibitspathogengrowth,althoughsomebacteria,suchasSalmonella,cansurviveforlongperiodsoftime.Inbetween,thereisarangeoffoodsthatmayhaveaWvaluesthatsupportgrowthofsomepathogens.GrowthofpathogenicbacteriastopswhentheaWis 0.86.Staphylococcusaureusistheonlyfoodbornepathogenthatgrows below 0. 2. Details on aW limits for specific pathogens areprovided in Appendix 4: Foodborne Pathogen SupplementaryInformation.

ItisimportanttorecognizethattherangeofaWvaluesforsomefoodcategoriescanbequitebroad.SpecificmeasurementsareneededforthesetypesofproductsifaWisusedasagrowthcontrolstrategy.Forfoodsthathavedifferentcomponents(suchasadonutwithacreamfilling)thepHandaWmaybequitedifferentinthecomponents.Inthedonutexample,thefillingmaybeacidicandhaveahighaW,whilethedoughnut part may have a near neutral pH and a lower aW. Theinterface between the filling and the donutmay be “just right” formicrobial growth, which may be an issue if contamination of theinterfaceisreasonablylikelytooccur.

The report Evaluation and Definition of Potentially Hazardous Foods provides information on pH and aW combinations that prevent foodborne pathogen growth. See Additional Reading.

Also see Chapter 13: Verification and Validation Procedures.

Definition

Water activity (aW): A measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

‐ 21 CFR 117.3

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Some pathogens prefer to grow at the concentrations of oxygenpresentintheairwebreathe;otherspreferorevenrequirelittleornooxygenbeforetheycangrow.Ofparticularconcernforfoodsafetyare anaerobic conditions (very low or no oxygen) that favor thepathogen C. botulinum. Changing the packaging to control oxygenlevelsmay change the hazards of concern for a food. For example,creation of anaerobic conditions through packaging can inhibitspoilage organisms, and extend shelf life. However, this anaerobicenvironment and longer shelf life may provide an opportunity forunanticipatedhazards,suchasgrowthofC. botulinum.Suchchangesshouldbecarefullyconsideredandstudiestovalidateproductsafetymaybenecessary.

Whenthereislittlecompetitionfornutrients,bacteriacanreproducerapidly. Conversely, the presence of other bacteria can inhibit thegrowth of certain pathogens. For example, production of toxin byStaphylococcusaureusmaybesuppressedwhencompetitivebacteriaarepresent.Fermentedproductslikeyogurt,whichhavehighlevelsofactivecultures,inhibitthegrowthofpathogenswhenfermentationproceedsatthenormalrate.

Preservatives, like nitrite, sorbate, proprionate and benzoate, mayslow or prevent the growth of pathogens as well as spoilagemicroorganisms.Theeffectivenessofthesepreservativesdependsonmanyfactors;thus,whenrelyingonpreservativestocontrolpathogengrowth, validation (See Chapter 13: Verification and ValidationProcedures) is essential to ensureefficacy. If notused at approvedconcentrations,somepreservativesmaybechemicalhazards.

For many foods, bacterial growth is often controlled using one ormoreofthefactorsdescribedabovetomakethefoodunsuitableforpathogengrowth.Somepreservationmethodsremovewater,making

Note:

Combinations of the factors that inhibit microbial growth can increase effectiveness and in some cases may even provide a level of inactivation. Data are needed to demonstrate that this occurs.

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thisessentialcomponentunavailabletobacteria.Forexample,bakingbreadorcrackersremoveswaterfromthefood.Acidificationisalsoacommon method of preservation (for example, pickles), as isrefrigeration (which slows growth), or freezing (which preventspathogengrowthentirely).CombinationsoffactorssuchaspHandaWmay inhibit organisms at levels where the individual factor alonewouldnot.Somepeoplerefertothisasthehurdleapproach.Useofacombination of factors frequently requires expert knowledge todevelopastablecombination.

Example: Salmonella as a Bacterial Foodborne Pathogen

Salmonellaisoneofthemostcommonfoodbornepathogens.Theslideabove illustrates information that is available in Appendix 4:FoodbornePathogenSupplementaryInformation.

Salmonellaisamongthemostcommoncausesofbacterialfoodborneillnessandcanbeanenvironmentalpathogen.Theinfectioncausesdiarrhea, fever, abdominal cramps and vomiting. Occasionally,Salmonellamaycausebloodstreaminfectionsanddeath.Severecasesmay also result in reactive arthritis. Foodborne illness symptomsgenerallyappear12to72hoursaftereatingcontaminatedfood.Theintestinal tractofanimals is theprimarysourceofSalmonella, thusraw animal products (meat, poultry, eggs, milk products) arefrequently associatedwith outbreaks. Because Salmonella surviveswell inmanyenvironments,many foodshavebeenassociatedwithoutbreaks, such as yeast, coconut, sauces, cake mixes, cream‐filleddesserts, gelatin, peanut products, chocolate and cocoa, and soyingredients. Fresh fruits, vegetables and nuts can be contaminatedduringgrowingifGoodAgriculturalPracticesarenotapplied.

Salmonellaiseasilykilledattraditionalcookingtemperaturesinhighmoisture environments, grows with or without air, grows best at

Note:

See Appendix 4: Foodborne Pathogen Supplementary Information for similar information for other bacterial pathogens. Understanding the characteristics of the pathogens of concern for the foods that you produce is important to select appropriate preventive controls.

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human body temperature, grows very poorly at refrigerationtemperatures and does not grow above 115 F (46 C). Unlikemostotherpathogens,somestrainsofSalmonellacangrowatapHaslowas3.7underotherwiseoptimumconditions.Itsurviveswellinfrozenanddry foods,aswellas indryprocessingenvironments(itcanbevery heat resistant in a dry state). Attempts to wet‐clean dryprocessingenvironmentshavebeenshowntospreadcontaminationandincreasetheriskofproductcontaminationbecauseofgrowthinenvironmentalnicheslikecracksandcrevicesthatcannotbereachedbysanitizers.ItisbesttokeepdryenvironmentsdrywhenSalmonellaisapotentialconcernsincemoisturecanallowittogrow.

Foodborne Viral Hazards

Likeothermicroorganisms,virusesarecommonintheenvironment.They are very small particles that cannot be seen with a lightmicroscopeandcannotreproducebythemselves.Virusescanpersistinfoodswithoutgrowing,becausetheyneednofood,waterorairtosurvive.Thoseassociatedwithfoodborneillnesscansurvivefreezinganddonotcausespoilage.

Virusescauseillnessbyinfectinglivingcellsandreproducinginsidethehost.Virusesgrowonlyinasuitablehostandonlycertainvirusesinfecthumans.Infectedpeoplearetheprimarysourceoffoodborneviruses. Foodborne viruses of concern can survive in humanintestines, contaminated water, frozen foods and environmentalsurfacesforweeksormonths.

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Themostcommonfoodborneviralhazardsarenorovirus(theleadingcause of foodborne illness in the U.S.) and hepatitis A virus. Otherviruses, such as rotavirus, may occasionally be associated withfoodborneillness,andmoremaybeidentifiedinthefuture.Whilethevast majority of viral outbreaks occur in foodservice settings,outbreakshavebeenassociatedwithprocessedfoods.Forexample,alargenorovirusoutbreakoccurred inGermany thatwasassociatedwithfrozenstrawberriesimportedfromChina.

Virusescaninfectconsumersthroughcontactwithinfectedpeopleorcontaminatedfoodorwater.Peoplewhoareillfromaviralillnesscanshedvirusesinveryhighnumbersinvomitorfeces.Evenwhentheyrecoverfromtheillnessandnolongershowoutwardsignsofillness,people can still shed the virus in saliva and feces. Transmission of

Norovirus is resistant to sanitizer concentrations used for food contact surfaces. An EPA registered disinfectant with claims against norovirus should be used. A general list of these products is available through EPA and the term “norovirus” or “Norwalk‐virus” will appear on an EPA‐registered disinfectant label. Carefully follow manufacturer’s label instructions for use. If used on a food contact surface, rinse the surface after treating and follow with a sanitizer at the appropriate concentration before using the equipment.

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virusestofoodsisusuallyrelatedtopooremployeehygienicpracticessuchasimproperhandwashingorworkingwhileactivelysheddingviruses. Therefore, prohibiting people with viral illnesses fromcomingintodirectcontactwithfoodreducesthechanceforfoodbornetransmission of viruses. Person‐to‐person transmission is verycommonforthevirusesassociatedwithfoodborneillnessoutbreaks,whichisanotherreasonforrequiringillindividualstostayhomefromwork– itpreventsotherworkers fromcontracting thediseaseandspreadingittofood.Outbreakshavebeentracedtofoodsexposedtoinappropriately treated water. This may be rare in developedcountries,butmaybeaconcernincertainregionsoftheworld.

Thoroughcooking is alsoaneffective controlmechanismandmostfoods associated with viral foodborne outbreaks are ready to eat.There is some evidence that highpressure processingmay also beeffectiveinreducingtheriskoftransmittingfoodborneviruses,andexplorationofvalidatedprocessesforspecificfoodsisnecessaryforthiscontrolstrategy.

Foodborne Parasites

Like viruses, foodborne parasites do not grow in food. Whilefoodborneparasiteoutbreaksare reportedmuch less frequently inthe U.S. than viral or bacterial agents, it is important to recognizepotential issues and sources and control for these agents. Parasiticfoodborne and water associated disease are more common incountries with poor sanitation. Appendix 4 provides briefdescriptionsofthefoodborneparasiteslistedabove.

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Some parasites may be transmitted through food or water that iscontaminated by fecal material shed by infected hosts or byconsuming infected animal tissue. Methods of preventingtransmission of parasites to foods by fecal contamination include:good personal hygiene practices by food handlers, elimination ofinsufficientlytreatedanimalwastetofertilizecrops,propersewageandwater treatment. Consumer exposure to parasites depends onfood selection, cultural habits and preparation methods. Parasiticinfections are normally associatedwith raw or undercooked foodsbecause cooking procedures that destroy pathogenic vegetativebacteriaalsokill foodborneparasites. Inspecific instances, freezingcan be used to destroy parasites in food. Freeze/thaw cycles canpreventinfectivityofGiardia,Cryptosporidium,Cyclospora,Trichinellaspp. and seafood‐related parasites (which are not covered in thistraining).

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Foods Associated with Foodborne Pathogens

Certain pathogenic bacteria, viruses and parasites are closelyassociatedwithparticularfoods.Controlofthesepathogensshouldbeconsideredwhenprocessingthesefoodsandfoodsthatcontainthemasaningredient.Ifyouprocessfoodproducts,itisimportanttohavea basic understanding of the most common foodborne pathogens,including where they come from (source), how they contribute tofoodborne illness, when they are a concern and what preventivecontrolscanminimizetherisktheypresent.

The table above is not a complete list of pathogens that may beassociatedwithvariousfoods.Itdoeslistsomeofthepathogensthatshouldbe consideredwhenperforming ahazardanalysis for theseparticularfoods.ThehazardanalysisprocessiscoveredinChapter8.Althoughitisnotnecessarytolistallpossiblepathogensthatcouldbeassociatedwith a specific food, you should take into account thosepathogensthatareknownorreasonablyforeseeable,eitherbecauseoftheirfrequencyofoccurrenceorbecauseofthepotentiallysevereconsequencesoftheirpresence.

Considerationofthedifferentpathogensallowsyoutodesignafoodsafetysystemthatwillcontrolallofthedifferentpathogens.Thisisusually done by designing the control procedure to be effectiveagainst the pathogen that is most resistant to the procedure. Forexample, if you decide to use cooking or pasteurization to destroypathogens,settingthecooktimeandtemperaturetokillthepathogenthatsurvivesathighertemperaturesforlongertimesthantheotherpathogens would also kill the other pathogens (althoughsporeforming pathogens may require different controls such asrefrigeration).Anotherreasonforconsideringindividualpathogensisthat ifanewpathogen is identifiedasaconcern(and thishappensfromtimetotime),youwillknowifyourplanhasconsideredit.

More information on these biological hazards is available in Appendix 4.

Most E. coli are harmless, but enterohemorrhagic E. coli (EHEC) can cause serious illness, including bloody diarrhea, blood‐clotting problems, and kidney failure and death.

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Inaddition topathogensnormallyassociatedwithparticular foods,therearepathogensassociatedwithcertainpractices.Forexample,the sporeformer C. botulinum grows only under anaerobic (lowoxygen) conditions. While the vegetative (growing) form of thispathogen is sensitive to heat, the spores are highly resistant andsurvive most cooking processes. A process that employs vacuumpackaginggeneratesanaerobicconditionsthatfavorgrowthandtoxinproductionbyC.botulinumwhentemperatureandotherconditionsaresuitable.

Biological Hazard Sources and Potential Controls

As previously discussed, biological contamination of food productstypicallycomesfromoneofthreedifferentsources–1)ingredients,2) the processing environment, including equipment or 3) people.Controls are needed tomanage the hazards introduced from thesesources.Forexample,sometimesingredienthazardscanbereducedtoasafelevelbyusingprocesscontrolssuchasacookingprocedureormaintainedatasafelevelusingtemperaturecontrol.However,notall products receive a cooking step or temperature control, andcookingmaynotbeeffectiveagainstsomepathogens.Inmanycasesthepreventivecontrolforthehazardisdonebythesupplier.Inthesecases, ifan ingredienthasahistoryofbeingapotentialsourceofaparticularhazard,asupply‐chainprogrammayberequired.This isdeterminedthroughHazardAnalysis(SeeChapter8:HazardAnalysisandPreventiveControlsDetermination).

Theprocessingenvironment,whichincludesequipment,isapotentialsourceofenvironmentalpathogensandcross‐contamination.Cross‐contamination occurs when pathogens are transferred from rawproducts to processed or ready‐to‐eat (RTE) products. Directcontaminationcanoccurwhenrawproductisstoredinacoolerwithcondensate dripping on processed product. Indirect cross‐

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contaminationoccurswhenasurfaceisusedforbotharawproductandRTEproduct,suchasputtingcookedproductbackintotherawproduct container. Cutting boards, work tables, tools and utensils,particularly those with hard to clean surfaces, are other commonsources of cross‐contamination. Cooking a product in‐package canpreventrecontamination,butcookingin‐packageisnotpossibleformany products. Effective sanitation controls, including cleaning,sanitizing and zoning, are useful to reduce the likelihood of post‐process and cross‐contamination. An environmental monitoringprogram could also be used to verify the effectiveness of thesecontrols. These types of controls are discussed in Chapter 11:SanitationPreventiveControls.

People with an illness or infection may potentially contaminateproduct.TransmissionofpathogensbyillemployeescantypicallybecontrolledwhenaddressedbyGMPsandtraining,whichisdiscussedinChapter3:GoodManufacturingPracticesandOtherPrerequisitePrograms. People can also serve as a vector for transmission ofpathogens from a raw product to a ready‐to‐eat product. Effectivehandwashingprocedures areneeded toprevent such transfer andagain,thisistypicallymanagedbyGMPs.Effectivetrainingisrequiredtomakefoodhandlersawareofthesesituationssotheycanpreventtheseoccurrences.

Biological Hazards Summary

Insummary,biologicalhazardscanpresentafoodsafetyriskifnotcontrolled.Theseverityoftheriskdependsonanumberoffactors,includingtheconsequenceofexposureandfrequencythatthehazardis observed with or without controls in place. Preventive controlsmust be designed, documented and implemented for all biologicalhazards requiring a preventive control. Because there are many

Determining which biological hazards require a preventive control for a specific food is covered in Chapter 8: Hazard Analysis and Preventive Controls Determination.

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potentialhazardsthatcouldbeconsideredintheproductionoffood,itisimportanttoidentifythosethatareofsuchimportancethattheymustbemanagedusingapreventiveapproach.Thiswillenableyouto focus resources on the most important hazards. The hazardanalysis process is an important step to identify those hazardsrequiringapreventivecontrol.ThisisaddressedinChapter8:HazardAnalysisandPreventiveControlDetermination.

Rememberthethreemainstrategiestocontrolbiologicalhazards–prevent contamination, kill them, and control grow. Strategies toprevent contamination must address ingredients, people and theenvironment, as relevant to the product beingproduced. Completeassurancethatyoucanpreventcontaminationmaynotbepossible.When killing pathogens is considered, remember that spores areharder tokill thanvegetativebacteria, frequentlyrequiringheatingunderpressuretoachieveeffectivetemperatures.Thisisnotfeasibleformanyfoods Finally,preventinggrowthusingtime,temperature,pH, water activity, atmosphere, competition, preservatives orcombination of these is important for many foods whencontaminationcannotbeguaranteed.

Additional Reading Appendix4:FoodbornePathogenSupplementaryInformation

FSPCAwebsitehaslinkstomanyofthefollowingreferencesusedtodevelopthischapter.

Barbosa‐Canovas,G. etal.2007.WaterActivity inFoods:FundamentalsandApplications,BlackwellPublishingandtheInstituteofFoodTechnologists.

CentersforDiseaseControlandPrevention.2012.FoodSafetywebsiteFDA. 2004.Guidance for Industry: JuiceHACCPHazards andControlsGuidance1st

Edition;FinalGuidance.FDA.2011.FishandFisheryProductsHazardsandControlsGuidance–4thEdition.FDA.2013.BadBugBook:FoodbornePathogenicMicroorganismsandNaturalToxins

Handbook–2ndEdition).

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FDA.2013.FoodCode2013.FDA.2014.DairyGradeAVoluntaryHACCP.FDA.2014.FoodborneIllness‐CausingOrganismsintheU.S.WhatYouNeedtoKnow.FDA.2014.ReportableFoodsRegistry.International Commission on Microbiological Specifications for Foods

(ICMSF).1 6.Microorganisms inFoods5:MicrobiologicalSpecificationsofFoodPathogens.BlackieAcademicandProfessional,New ork

ICMSF. 2005. Microorganisms in Foods 6: Microbial Ecology of FoodCommodities.KluwerAcademic/PlenumPublishers,New ork

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CHAPTER 5. Chemical, Physical and Economically Motivated Food Safety Hazards

Aswithbiologicalhazards,indevelopingormodifyingaFoodSafetyPlan, it is important tobeawareof thepotentialchemical,physicalandeconomicallymotivatedhazardsthatareassociatedwiththefoodproductsandprocessesunderconsideration.Whenthesehazardsareunderstood, preventive measures can be implemented to controlthem, thus preventing illness or injury. This section builds on theoverviewinformationpresentedinChapter4:BiologicalFoodSafetyHazards and discusses chemical hazards that are commonly ofconcerninfoodprocessingfacilitiesandthoseholdingfoodproducts.Radiological hazards, which are encountered less frequently, arediscussed under chemical hazards. This chapter also addressesphysical hazards and economicallymotivated hazards thatmay beassociatedwithspecifictypesoffoodorfoodproductionpractices.

Aswithbiologicalhazards,informationfromthischapterisusefulforconductingahazardanalysisforafood.Thehazardanalysisprocessisdiscussed inChapter8:HazardAnalysisandPreventiveControlsDetermination.

RecallthatthePreventiveControlsforHumanFoodregulationdefineshazard as “any biological, chemical (including radiological), orphysical agent that has the potential to cause illness or injury.”Chemicalhazardsincludefoodallergens,mycotoxins,toxicchemicals,

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radiologicalagents,etc.;andphysicalhazardsincludemetal,glassandotherobjectsthatcancauseinjury.

oumayrememberthisslidefromthepreviouschapterthatidentifiesmany conditions that are highly undesirable in food, such as thepresenceofinsects,hair,filthorspoilage,butthatarenotnecessarilyfoodsafetyhazards.Economicfraudandviolationsofregulatoryfoodstandards are equally undesirable. All of the defects on this slideshouldbecontrolledinfoodprocessingorthroughGMPs;however,manytimestheyarenotdirectlyrelatedtothesafetyoftheproduct.Unless these conditions directly affect food safety, they are notincludedinaFoodSafetyPlan.Forexample,decompositioncanbeafoodsafetyhazardwhenbiogenicaminesorother toxicsubstancesareproduced.

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Chemical Hazards

Contaminationfromchemicalhazardscanhappenatanystageinfoodsourcing, production, processing and distribution. Some “naturallyoccurring”chemicalhazardsareanaturalcomponentofafood,suchas food allergens, or are produced in the natural environmentunrelated tohumanactivity, such as seafood toxins ormycotoxins.Otherchemicalsubstancesmaybehazardousduetoerrorsinproductformulation,suchassulfitesorotherfoodadditives.Stillothersmaybe unintentionally present in the food, such as heavy metals,industrialchemicals,pesticidesordrugresidues.

Thepresenceofachemicalresidueinafoodisnotalwaysahazardand may be unavoidable. The amount and type of the chemicalsubstancedetermineswhether it isahazardornot.Somechemical

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hazardscancauseimmediateornear‐termillnessorinjury,suchasfood allergens (discussed below) or high concentrations of certainchemicals.Otherchemicalhazardsrequireexposureoveraprolongedperiodtohaveatoxiceffectinhumans,suchasleadcontaminationofcandy resulting in impaired cognitive development in children andcancerscausedbycertaintoxinsinfood.

The safety of chemicals used in food and food processingmust beevaluatedonause‐by‐usebasis.Regulatory limitsareset formanychemical contaminants. These limits consider long term and shortterm exposure consequences, quantity, toxic potency, potentialbenefitslikeantimicrobialactivity,andsimilarproperties.FDAactionlevels for specific hazardous chemicals in specific commodities arepublished in the bookletAction Levels for Poisonous orDeleteriousSubstancesinHumanFoodandAnimalFeed.Ifthereisnotolerance,actionlevelorotherregulatorylimitforaspecifichazardouschemicalinaspecificfoodproduct,concentrationsmustbebelowthelimitofcurrentstandardsforanalyticaltesting.

Chemical hazards of particular concern are listed above and theuniqueconcernsforthesehazardsarediscussedbelow.

Naturally Occurring Chemicals As previously mentioned, naturally occurring chemical hazardsinclude those present in a food or produced in the naturalenvironmentunrelatedtohumanactivity.Forexample,somecheesesand other food may contain histamine as a result of microbialfermentation converting histidine to histamine. Some people aresensitive to low levels; others require exposure to high levelsproducedinveryripeproductsoffermentation(Strattonetal.1 1).Extendedfermentationcanresultindecompositionofthefood.Other

Action Levels for Poisonous or Deleterious Substances in Human and Animal Feed contains information on levels of chemicals that are prohibited in certain foods. These levels are based on FDA’s assessment of long term and short term effects of consuming the specific chemical.

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naturallyoccurringchemicalsincludefoodallergensandmycotoxins,eachofwhichisdiscussedbelow.

Food Allergens

We will start with food allergens as an example of a naturallyoccurring chemical hazard. As previously mentioned, undeclaredallergensinfoodsrepresentaboutonethirdofthereportsinFDA’sReportableFoodRegistry.

Foodallergensarenaturallypresentincertainfoodsandthesefoodsareexamplesofingredientsnormallyusedinfoodthatdonotpresenta chemical hazard for most people. However, they can be a lifethreatening for thosewith a food allergy. It is estimated that foodallergiesaffectfourtosixpercentofchildrenandtwotothreepercent

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ofadultsintheU.S.Thepresenceofundeclaredallergensinfoodisamajor causeofproduct recalls.A foodallergen reaction is abody’simmunologicalresponsetoproteinsinthefoodthatthebodyseesasforeign.Thesereactionsare fast‐actingandshouldnotbeconfusedwithfoodintolerance,suchaslactoseintolerance.

Peoplewithfoodallergiescanexperienceavarietyofsymptomsthatcanbemildtosevereandcanaffectdifferentsystemsinthebody.Theseverity of the response depends on the amount of the allergenconsumedand individualsensitivity.Mildallergicresponsescanbetreatedwithantihistamine,butseriousreactionslikeanaphylaxisaretreated with epinephrine. Anaphylaxis is a generalized reaction,whichcanincludemultipleorganfailure,anyoftheothersymptomslistedabove, severe lossofbloodpressureandcardiacarrhythmia.Thisreactioncanbefatal.Tensofthousandsofemergencyroomvisitsand 150‐200 deaths per year can be attributed to anaphylacticreactions.

Reactionsusuallyoccur1–30minutesafterexposure,butmaytakeupto2hours.Foodallergysufferersmayexperiencemultipleseverereactions in their lifetime. Childrenwith asthma andmultiple foodallergies are at increased risk for anaphylaxis. Milk, soy and eggallergiesmaybeoutgrown;butpeanut,treenutandshellfishallergiesoftenpersistthroughoutlife.

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Manyfoodscancauseanallergicreactioninpeople,buteightfoodsareresponsibleforover 0 oftheallergicreactionsintheU.S.Thesearemilk,egg,peanut, treenut, fish, crustaceanshellfish,wheatandsoy. TheU.S. FoodAllergen Labeling and Consumer Protection Act(FALCPA)mandateslabelingoftheseallergens,whichcausemostofthefoodallergyreactions.Forproductgroupsliketreenuts,fishandcrustaceanshellfish,thespecifictypeoftreenutorfishmustalsobelabeled.

Foodallergysufferersmustpracticecompleteavoidanceofthefoodallergen in order to avoid allergic reactions. The ability to practiceavoidance depends on factors outside the control of the individualsufferer.Properlabelingoffoodproductsalongwithstrictmonitoringoflabelsisrequiredforavoidingspecificallergens.Foodprocessors

The FDA has responses to frequently asked questions related to food allergens on their website. See Additional Reading or search the FDA website.

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must have accurate information about their ingredients andunderstand their processing conditions related to allergen cross‐contact opportunities in order to fully assess their own products.Accurate allergen labeling is required to be addressed in the FoodSafetyPlan.

Thenumberofrecallsassociatedwithundeclaredallergensillustratesthatthisisarealissueinthemarketplace.MoreFDAregulatedfoodrecalls were associated with undeclared allergens than any otherissuefortheyears2010,2011and2012combined.Implementingacomprehensive food allergenmanagement program is not only therightthingtodofromafoodsafetyperspective,butalsoisimportanttoprotectabusinessfromrecalls.

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AllergenlabelingmustbeaddressedintheFoodSafetyPlan,whichisconsistentwiththeobservationthatmostallergenrecallsarerelatedto labeling issues, such as use of thewrong label or package for aproduct.Specificlabelingterminologymaybeincorrect,suchasnotlabeling butterwith the term “milk,”which is required by labelingregulations.Sometimesaprocessormayoverlookaminoringredientin one of their ingredients and not include it on the label. Foodallergensinprocessingaidsshouldalsobeconsideredandmayneedtobeincludedinanallergenlabelingdeclaration.Labelingerrorsmayalso involve using thewrong ingredient bymistake or on purpose(e.g.,intentionallysubstitutingdifferentnuts,duetoshortageorcostsaving,withoutchangingthelabel)orusingreworkwithadifferentallergenprofileinaformulation.

Allergencross‐contactwithotherfoodsthroughinadequatelycleanedequipmentorfoodworkershandlingbothanallergen‐containingfoodandanon‐allergencontainingfoodisalsoanissuethatcanpresentarisk toallergic consumers.Thepotential forallergenscrossing intonon‐allergenprocessingstreamsmustbeconsideredinaFoodSafetyPlan.

Many of the other causes listed on the slide are related to lack ofknowledge of the issue or inadequate management of change.Ensuring that all relevant people are aware of potential allergenissuescanminimizethepotential forharmingapersonwitha foodallergyandcanhelpavoidarecall.

Understanding how undeclared allergens get into products is thestarting point for developing an effective allergen managementprogram. Chapter 10: Food Allergen Preventive Controls discussesrequired food allergen preventive controls, specifically accuratelabeling and allergen cross‐contact prevention, and approaches tohelpmanagetheseissues.

Jackson et al. (2008) review of Cleaning and Other Control and Validation Strategies to Prevent Allergen Cross‐contact in Food‐processing Operations outlines components of a comprehensive allergen control plan, which meets or exceeds the requirements for Preventive Controls compliance.

See Additional Reading.

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While not required by the Preventive Controls for Human Foodregulation,productdesigncanplayanimportantroleinminimizingfood allergen controls in production. For example, some productsrequire a protein source as a firming agent, and egg, soy or milkprotein can potentially have the same functionality. If a developerknowstheallergenprofileforaproductionline,theymaybeabletochoose ingredientswith the sameallergens, thus reducing allergencross‐contactconcerns.

Consideronlyaddingnewallergenstoproductswhentheymakeanimportantdifferenceinthetasteorfunctionalityoftheproduct.Ifanallergen‐containingingredientisrequired,considerdifferentformatstoreduceallergencross‐contactissues.Forexample,itisdifficulttomakewalnutbrownieswithout introducingwalnuts, but if you aremaking amix, a separate packet containingwalnuts could be usedinstead of loose walnuts in the mix to minimize the exposure ofequipmenttotinypiecesofwalnutsthatmakecleaningdifficult.

Beforeanewallergenisaddedtoanexistingproductorline,considerthepotentialcoststomanagethenewallergenintheprojectplan.Thiscan help you to determine if the change is really beneficial. If youdecidetoaddanewallergentoanexistingformula,includingalabelelementsuchas“Newformula”isusefultoalertallergicconsumersthatanewallergenisinaproduct.Manyfoodallergicconsumersareverybrandloyal.

Mycotoxins

Mycotoxinsarechemicalhazardsproducedbycertaintypesofmoldswhenextensivegrowthoccursoncommoditiesofconcern.Aflatoxinsareatypeofmycotoxinthatisproducedbycertainmoldsthatgrowoncorn,peanutsandothercommoditiesinthefieldorduringstorage.Othermycotoxins,suchasochratoxinA,fumonisins,deoxynivalenol

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(DONorvomitoxin)andzearalenonecanpresentahazard incropssuch as grains, fruits and tree nuts. Patulin is a potential issue onfruits. The molds that produce mycotoxins typically becomeestablished in commodities of concern under stressful growingconditions. Themolds can growduring storage of grainswhen thegraincontainsmoistureaboveacertainlevel,whichcanvarybycropandmoldtype.Inyearsandlocationswithgoodgrowingandharvestconditions, mycotoxins are not usually a hazard requiring apreventive control. However,when stressful growth conditions forcrops or particularly wet harvest seasons for some crops occur,mycotoxinpreventivecontrolsmaybewarranted.Thismayincludepreventivecontrolsforfeedusedformilk‐producinganimals,becauseaflatoxinpresentinmoldygraincanbechangedtoaflatoxinMbythecowandpassedonthroughmilk.

Avarietyofcontrolsthroughoutthesupplychaincanbeappliedtoreduce the potential presence of mycotoxins. Conditions such asinsectdamageanddroughtstresscanpromotemycotoxinformation.After harvest, rapid drying can prevent mycotoxin formation (ormaintainthemycotoxinlevelthatcameinfromthefield),whileslowdrying increases them. Similarly, proper dry storage maintainsmycotoxins at incoming concentrations, while in poor storageconditions(e.g.,allowingcondensation)concentrationscanincreaseagain.Duringprocessing,colorsortingandtestingatvariousstagestorejectmaterialwithunacceptableconcentrationscanreduce levels.Theeffectofprocessingonmycotoxinshasdemonstratedthatwhilesomereductionmayoccur,completeeliminationdoesnot(MilaniandMaleki2014).

Chemical Substances Used in Formulation

Some chemical substances are added during formulation. Theyincludefoodadditives,coloradditives,preservativessuchassulfites,

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andnutritionaladditives.Otherchemicalsmaybeusedinprocessing,e.g.,antimicrobialsusedinwashwaterforfresh‐cutproduce.Thesesubstancesareintendedtobeusedatsafelevels,butcouldpresentahazardifthoselevelsareexceeded.

FDAsetstheconcentration,mannerofuseandmaximumallowableresiduesforcertainchemicalsubstancesinfood(seeActionLevelsforPoisonousorDeleteriousSubstancesinHumanFoodandAnimalFeed).Keeping within these limits is important for safety as well asregulatorycompliance.Thesechemicalsubstancesarenothazardousif properly applied and controlled. Potential risks to consumersincreasewhenthesesubstancesarenotproperlycontrolled,suchasexceedingtherecommendedusageratesoraccidentallyintroducedinthewrongplaceorfood.

Chemicals Unintentional or Incidentally Present

Chemicals can become part of a food without being intentionallyadded. These incidental chemicals might already be in a foodingredientwhenitisreceived.Forexample,fruitsorvegetablesmaycontain small but legal residues of approved pesticides. Packagingmaterialsthatareindirectcontactwithingredientsortheproductcanbe a source of incidental chemicals, such a as inks. Cleaning andsanitizing chemicals are necessary to maintain a sanitaryenvironmentfortheproductionoffoodproducts,andsmallamountsof sanitizersmay remainon equipment surfaces. It is important tofollowlabelinstructionstoensuretheirsafeuse.

Mostincidentalchemicalshavenoeffectonfoodsafetyandothersareonly a concern if they arepresent in excessive amounts. Incidentalchemicalsalsoincludeaccidentaladditionsofprohibitedsubstances.Abrief discussionof pesticides, industrial chemicals, heavymetals,drugresiduesandradiologicalhazardsfollows.

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Pesticides

Certainpesticidescanbeapplieddirectlytofoodorcropstocontrolweeds,insectsormicrobialcontamination.Otherpesticidescannotbeapplied directly to food; e.g., for rodents control. Pesticides can beusedlegallyonlyiftheyareregisteredwiththeappropriateauthority(seebelow)andusedaccordingtoconditionsdescribedonthelabel.Numerous U.S. regulatory programs address aspects of pesticideusage,likeapplicatorlicensure,usageinstructionsonthelabel,officialmonitoring of pesticide residues in foods and enforcement actionsagainst violators.Experience in theU.S. hasdemonstrated thatU.S.grownfruitsandvegetableshaveahighlevelofcompliancewithU.S.pesticide toleranceregulationsand that theoccurrenceofunlawfulpesticide residues in food is likely tobe infrequent andunlikely tohaveasignificantpublichealthimpact.Becauseofthis,pesticideuseintheU.S.isfrequentlymanagedthroughapplicationofGMPs.

TheU.S.EnvironmentalProtectionAgency(EPA)registerspesticidesfor use in the U.S., establishes label instructions for use, and setstolerances for residues of pesticides in food based on safety andconditionsofuse.FDAtestsfoodforpesticideresiduesforcompliancewithU.S.tolerances.IfaU.S.tolerancehasnotbeenestablishedforaparticularpesticideinacommodity,thenanyamountmeasuredmaybeconsideredviolative.Therefore,checktoseeifpesticidesusedinfoodsyou import are in compliancewithU.S. pesticide laws.WhilepesticidecomplianceexperienceforimportedfruitsandvegetablesisgenerallycomparabletothatforU.S.produce,youshouldensurethatgovernment controls in the country that supplies your importedproduce result in a high rate of compliance with U.S. pesticidetoleranceregulations.IfyoucannotachievethisassuranceyoushouldevaluatecarefullywhetherpesticideresiduesposeahazardrequiringapreventivecontrolinyourFoodSafetyPlan.

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Industrial Chemicals

Food crops can be harvested from areas that are contaminated byvarying amounts of industrial chemicals including dioxins andpolychlorinatedbiphenyls(PCBs).“Dioxins”isacollectivetermforagroup of environmental contaminants that includes certain dioxin,furananddioxin‐likePCBcompoundsthatarefoundthroughouttheworld.Theyarereleasedintotheairfromcombustionprocesses,suchas commercial or municipal waste incineration and from burningfuels,suchaswood,coaloroil.Burningofhouseholdtrashandforestfires can also result in the release of dioxins and furans into theenvironment.AccidentalorintentionalreleaseoftransformerfluidshasresultedinthepresenceofPCBsintheenvironment.

Becausedioxinsbreakdownveryslowly,dioxinsreleasedinthepastfrom both man‐made and natural sources still exist in theenvironmentandcannotbequicklyreduced.Dioxinscanbedepositedon plants that are then eaten by animals. Thus, they may beconcentratedinthefoodchainsothatlivestock,fishandshellfishcanhavehigherconcentrationsthantheplants,water,soilorsedimentsaround them. An evaluation of the potential for contamination ofcropsbydioxinandrelatedmaterialsmaybeworthconsidering.

The FDA provides information on chemical contaminants on its website. See Additional Reading or search the FDA website to get the latest information.

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Heavy Metals

Heavymetalssuchasarsenic,lead,andmercurymayaccumulateinfishorplantsifthegrowingenvironmenthashighconcentrationsofthese chemical hazards. Examples include arsenic accumulation inrice, mercury accumulation in large fish and lead accumulation incarrots grown in fields that previouslywere orchards treatedwithlead‐basedpesticides.Assessmentofthegrowingregionpriortousecanhelptoavoidthesehazards.

Heavymetalsmayalsoleachfromequipmentifsuitablematerialsarenotused, especially for food contact equipment.GMPs require thatfoodcontactsurfacesbemadeofsuitable,non‐toxicmaterial.

Drug Residues

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Drugs are an important part of animal health, welfare andmanagement,butmaypresentachemicalhazardwhennotmanagedappropriately.Thepresenceof inappropriatedrugresidues in foodmay cause short term effects on consumers, allergic reactions orchronictoxiceffects.

Animaldrugsrequirepremarketapprovalbeforetheymaybelegallyused. Drug residues (e.g., antibiotics administered to dairy cows)presentinfoodderivedfromananimal(suchasmilk)canbeahazardif a tolerance has not been established for the food, or if such atolerance is exceeded. If drug residues are identified as a hazardrequiringapreventivecontrolinthehazardanalysis,theapplicationof a supply‐chain program would be considered as a preventivecontrol.

Radiological Hazards

Radiologicalhazardsarerarelyencounteredinfood;however,whentheydooccur,radiologicalhazardscanpresentarisk.AccordingtotheWorldHealth Organization, radiological hazards in foodwouldhave to be consumed over a period of time to present a risk (seeadditional reading). Examples of radiological hazards includeradionuclides such as radium‐226, radium‐228, uranium‐235,uranium‐238,plutonium‐23 ,strontium‐ 6,iodine‐131andcesium‐137.Themostcommonwaytheseradionuclidesareincorporatedintofoodsisthroughuseofwaterthatcontainsaradionuclideduringfoodproductionormanufacture.Forexample, incertain locations intheU.S. high concentrations of radium‐226, radium‐228 and uraniumhavebeendetectedinprivatewells.Thisshouldbeconsideredinthehazardanalysisintheseregionsbutwouldnotbeapplicableinmostregions.

Frequently a certificate can be obtained from a municipal water supplier that demonstrates compliance of water to EPA standards for radionuclides.

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Radiologicalhazardsalsomayresultfromaccidentalcontamination,suchascontaminationarisingfromaccidentalreleasefromanuclearfacilityordamagetoanuclearfacilityfromanaturaldisaster.In2011,radioactivitywasdetectedinmilk,vegetablesandseafoodproducedin areas neighboring a nuclear power plant damaged during anearthquakeandtsunamiinJapan.

Potential Controls for Chemical Hazards

ManychemicalhazardscanbeeffectivelymanagedthroughGMPsandotherprerequisiteprograms.Thehazardanalysisprocessdeterminesthechemicalhazardsrequiringapreventivecontrol.Understandingwhereyour ingredientscome fromandassuring thatyoursupplierhasappropriatecontrolsinplacetomanagechemicalhazardsisthefirststepinmanagingsuchhazards.Thismayrequireasupply‐chainprogramasapreventivecontrol.FDAguidanceisavailableforknownchemical hazards in themarket place. our suppliersmust complywith regulatory limits. Sanitation preventive controls can be animportantpreventive control for allergens if youproduceproductswith different allergen profiles. Allergen labeling, of course, is animportantandrequiredallergencontrolifanyofyouringredientsorraw materials contain food allergens (see Chapter 10: AllergenPreventiveControls).Processpreventivecontrolsmayberelevanttocertainpotentialchemicalhazardsdependingonthenatureofyourproduct.

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Chemical Hazards Summary

Chemicalhazardscanenterfoodasnaturallyoccurringsubstances,asingredientsorrawmaterialsthatareusedintheformulation,andasunintentionally or incidentally present substances. The allowablelevels, ifany,areestablishedbyFDA(orEPAforpesticides),whichalso provides guidance on potential controls for many chemicalsubstances.Asupply‐chainprogrammayplayakeyroleinmanagingchemical hazard risks. Sanitation, allergen and process preventivecontrolsmayalsobeimportantcontrols,dependingonyourproductandprocessandresultsofyourhazardanalysis.

Physical Hazards

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Foreign Objects Physicalhazardsincludeanypotentiallyharmfulextraneousmatternotnormallyfoundinfood.Dependingonthesizeandshapeoftheobject, itmay cause choking, injury in themouth or other adversehealtheffects.FDA’sHealthHazardEvaluationBoardhassupportedregulatory action against products with hard, sharp and pointedfragmentsof0.3inches(7mm)to1.0inches(25mm)inlength(seeFDA2005 inAdditionalReading).Keep inmindthatnotall foreignobjectsfoundinfoodduringfoodprocessingorholdingpresentatruefoodsafetyrisk.Objectslikestringandpaper,forexample,mayoccurbutareunlikelytopresentathreattohealthinmostsituations.TheFoodSafetyTeamshouldaddressintheirFoodSafetyPlanonlythosehazardsthatarereasonablylikelytocauseinjury.

Glass Hazards Glassfragmentscancauseinjurytotheconsumer.Glassinclusioncanoccur whenever processing involves the use of glass containers.Normal handling and packaging methods, especially mechanizedmethods, can result in breakage. Glass fragments originating fromother sources must be addressed, e.g., through GMPs, and manyfacilitiesthatdonotpackinglassprohibitthepresenceofglassintheproductionenvironment toreduce theriskofglassgetting into theproduct.

Plastic Plastic is frequently used as a substitute for glass orwood in foodhandling areas. In selecting the plastic material, use of less brittlematerial will reduce the need to consider plastic as a true risk tohumanhealth.Looseplasticmayalsobeapotentialchokinghazard.

Metal Hazards Metal‐to‐metalcontactinequipmentcanintroducemetalfragmentsinto products. Examples include mechanical cutting and blendingoperations and equipment that has parts that canbreak or fall off,such as wire‐mesh belts or screens. Fine metal shavings may notpresentahazardbuthardandsharpfragmentsofthesizenotedaboveare a hazard to consumers. This hazard can be controlled bysubjecting the product to metal detection devices or by regularinspectionofat‐riskequipmentforsignsofdamage.

Stones Certainingredients,especiallythoseofplantorigin,mayoccasionallyhavestonespresentintherawmaterial.Dependingonthesizeandshapeof thestones, theymaypresentahazard fordental injuryorchoking.Stonesarefrequentlyheavierthantheingredientmaterial,thuswashingsteps,flotation,riffletanksandsimilarstepscanremovestones from a process. The Food Safety Team should assess thefrequency of observation of stones from their source of supply todetermineiftheypresentahazardrequiringapreventivecontrol.

FDA has taken action against physical hazards that are hard, sharp and pointed and 0.3 inches (7 mm) to 1.0 inches (25 mm) in length.

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Wood Likeotherpotentialphysicalhazards,woodcanpresentapotentialchokinghazardandlesscommonlyapotentialhazardforcutsinthemouthincertainsituations.Thehazardofcutsdependsonsharpnessoftheedgesofthewood,whichmaynotbeanissueinamoistfoodproduct.Manyfacilitiesavoidtheneedtoconsiderwoodasahazardbylimitingorprohibitingthepresenceofwoodinareaswherefoodisexposed.Othersmayconsiderhistoryofcomplaintstodetermineifatruehealthhazardexists.

Choking Hazards for Young Children

Choking occurs when a person cannot breathe because an objectblockstheairway(windpipe,esophagus).Thepotentialforachokinghazard is a consideration for foods that are specifically targeted toyoung children because of their smaller windpipe, and because oftheirswallowingmechanismandabilitytochewarelessdevelopedthan that of an adult. Foods that are frequently associated withchokinginchildrenincludethosethathaveacylindricalshapeandcanbecompressed,whichallowsthemtowedgeinachild’sthroat.Foodsthatpresentahighriskforachild’schokinghazardincludehotdogsand similar sausages, round candy, whole grapes,nuts/peanuts/seeds,rawcarrots,apples,popcorn,chunksofpeanutbutter,marshmallowsandchewinggum.

While standards related to choking hazards for foods intended forchildrendonotexist,theConsumerProductsSafetyCommissionhasstandards for children’s toys, including a small‐parts test fixture(SPTF)thatisusedtoassesswhetherapiecesizepresentsapotentialchokinghazardforyoungchildren.Thisdevice,picturedinthefigureabove,maypotentiallybeusefultoevaluatefoods.Iftheproductfitsinto the cylinder, it may be a choking hazard for young children.

The American Academy of Pediatrics article on “Prevention of Choking Among Children” provides background information on reducing this hazard for food products. See Additional Reading.

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Manufacturers designing food specifically for young children maywishtoconsiderthistoevaluatewhetherthefoodrepresentsariskandredesigntheproductifthisisthecase.

Economically Motivated Hazards

Whileitisarareoccurrence,hazardsmaybeintroducedintofoodforthepurposesofeconomicgain.Economicallymotivatedadulterationthataffectsproductintegrityorquality,butnotfoodsafety,shouldnotbeaddressedinaFoodSafetyPlan.ThePreventiveControlsforHumanFoodregulationonlyrequiresconsiderationofhazardsiningredientswithapatternofeconomicallymotivatedadulterationinthepast.ACongressionalResearchService(2013)reportprovidesinformationoneconomicallymotivatedadulterationoffoodandfoodingredients.Everstine et al. (2014) identified 137 unique incidents in 11 foodcategories(SeeAdditionalReading).

An example of a widespread incident of economically motivatedadulteration occurred in China, where melamine, a nitrogen‐richindustrialby‐product,wasaddedtodiluteddairyproductsbysomemilkfirmstoincreasetheapparentproteincontent.Thisresultedinmorethan2 0,000illinfantsand6deathsinthatcountry.Inlightofthis incident, the potential for melamine to be an economicallymotivated adulterant in milk products from a country wheremelamine adulteration has occurred is prudent. Conversely, sincenone of this adulteratedmilkwas exported to theU.S. and noU.S.suppliers have been a source of food safety problems due to milkproductsadulteratedforeconomicgain,FDAdoesnotexpectafacilityto consider the potential for melamine to be an economicallymotivated hazard when using domestic milk products, or milkproducts from other countries with no history of melamineadulteration.

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Anotherexampleofeconomicallymotivatedadulterationisadditionof dyes containing lead to ingredients such as spices or candy toenhancecolor.Leadcanaccumulateinthebodyovertimeandcausehealthproblemssuchasimpairedcognitivedevelopmentinchildren.Leadchromate,achemicalwithavibrantyellowcolor,hasbeenanadulterantinturmerictochangethecolor(FDA2013).Leadoxide,ared chemical, was an adulterant in paprika to enhance its color;resultingindozensofillnessesandseveraldeathsinHungary(Anon.1 5). Sudan I, an orange‐red powder, used to be added to chilipowder as a coloring agent, but is now banned inmany countriesbecause it is classifiedasa category3carcinogen (see IARC2014).Contamination of an ingredient prepared using chili powdercontaining Sudan I led to a massive recall of food products in theUnitedKingdom(UKFoodStandardsAgency2005).

Economicallymotivatedhazardsare typicallymanagedthroughthefacility’ssupply‐chainprogram.Remember,youonlyneedtofocusoneconomicadulterationthathasahistoryofresulting inahazard infood.

Summary of Hazards

Chemical(includingradiological)andphysicalhazardscanpresentafoodsafetyriskifnotcontrolled.Theseverityoftheriskcandependonanumberof factors, includingtheconsequenceofexposureandfrequencythatthehazardis.Preventivecontrolsmustbedesigned,documentedandimplementedforallfoodsafetyhazardsrequiringapreventive control. Because there aremany potential hazards thatcould be considered in the production of food, it is important toidentifythosethatareofsuchimportancethattheymustbemanagedusing preventive controls to ensure that you will be able to focusresourcesonthesehazardseverytime.Thehazardanalysisprocessisan important step to identify those hazards requiring a preventive

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control. This is addressed in Chapter 8: Hazard Analysis andPreventiveControlDetermination.

Additional Reading The preamble to the final regulation, as well as the proposed andsupplemental regulation may provide additional information oneconomicallymotivatedhazards inhuman food.Additional readingon other topics is below, and links for many of these articles areavailableontheFSPCAwebsite.

AmericanAcademyof Pediatrics. 2010.Policy Statement – Preventionof ChokingAmongChildren.Pediatrics125(3):601‐607.

Anon.1 5.AdulterationofpaprikainHungary.LEADActionNews3(3).Congressional Research Service. 2014. “Food fraud and “economically motivated

adulteration”offoodandfoodingredients,January10,2014Everstine,K.,J.Spink,S.Kennedy.2013.Economicallymotivatedadulteration(EMA)

offood:commoncharacteristicsofEMAIncidents,JFoodProtection76:723‐735.FDA. 2000. Guidance for Industry: Action Levels for Poisonous or Deleterious

SubstancesinHumanFoodandAnimalFeed.FDA.2004.GuidanceforIndustry:JuiceHACCPHazardsandControlsGuidance1st

Edition;FinalGuidance.FDA. 2005. Foods ‐ Adulteration Involving Hard or Sharp Foreign Objects.

CompliancePolicyGuidelines555.425.FDA. 2006a Guidance for Industry: uestions and Answers Regarding Food

Allergens,includingtheFoodAllergenLabelingandConsumerProtectionActof2004(Edition4);FinalGuidance

FDA. 2006b. Supporting document for recommended maximum level for lead incandylikelytobeconsumedfrequentlybysmallchildren,November,2006.

FDA.2013.BestValue, Inc.,RecallsPRANBrandturmericpowderdue toelevatedlevelsoflead.October16,2013.

FDA.2014.ChemicalContaminantsFDA.2014.DairyGradeAVoluntaryHACCP.FDA.2014.ReportableFoodsRegistry.Gendel,S.M.and J. hu.2013.AnalysisofU.S.FoodandDrugAdministration food

allergen recalls after implementation of the Food Allergen Labeling andConsumerProtectionAct.JFoodProtection76(11):1 33‐1 38.

IARC(InternationalAgencyforResearchonCancer).2014.AgentsclassifiedbytheIARCMonographs,Volumes1‐10 ,”January14,2014.

Milani,J.andG.Maleki.2014.Effectsofprocessingonmycotoxinstabilityincereals.J.Sci.FoodAgr. 4:2372‐2375.

Stratton J.E., RW Hutkins SL. Taylor 1 1. Biogenic amines in cheese and otherfermentedfoods:areview.J.FoodProtection54(6):460‐470.

U.K.FoodStandardsAgency.2005.SudanItimeline,February24,2005.WorldHealthOrganization.2011.FA s:Japannuclearconcerns.

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CHAPTER 6. Preliminary Steps in Developing a Food Safety Plan

Before building a Food Safety Plan, organizing information isimportant. These preliminary steps involve gathering informationabout the products, processes and facility operations to build acompletepictureofthefacility.ThisinformationisneededtoidentifypotentialhazardsandpreventivecontrolmeasureswhendevelopingaFoodSafetyPlan.

ThesepreliminarystepsarenotrequiredbythePreventiveControlsforHumanFoodregulation,buttheinformationisneededtoprovidea sound basis for applying preventive controls principles indevelopingaFoodSafetyPlan.TheyarealsoconsistentwithU.S.andinternationally recognized principles for developing prevention‐basedfoodsafetycontrols.Adiscussionofeachofthefivepreliminarystepsfollows,withexamplestoillustratetheprocess.

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1. Assemble the Food Safety Team

AssemblingafoodsafetyteamisanimportantstepinbuildingaFoodSafety Plan. Management commitment is extremely important toensure that resources dedicated to this effort are appropriate.Effectivefoodsafetymanagementnotonlyprotectsthefood;italsoprotects the business from the risk of a food safety incident or aregulatory non‐compliance issue. To develop and implement aneffectiveFoodSafetyPlan,abudget,resources,andsupportforchangemanagement, potential changes in equipment, newprocedures etc.mayberequired.Withoutfirmmanagementcommitmentatalllevels,itmay be difficult to implement an effective Food Safety Plan. Topmanagementcommitmenttofoodsafetysendsastrongmessagetoallpersonnel that the food safety system is vitally important to thecompany.

AlthoughonepersonmaybeabletoanalyzehazardsanddevelopaFoodSafetyPlansuccessfully,manycompaniesfindithelpfultobuildafoodsafetyteam.WhenonlyonepersondevelopstheFoodSafetyPlan,somekeypointscanbemissedormisunderstoodintheprocess.The team approach minimizes the risk of missing key points ormisunderstanding aspects of the operation. It also encouragesownership of the plan, builds company involvement and brings indifferentareasofexpertise.At leastonememberof the foodsafetyteam should be a preventive controls qualified individual, who hassuccessfully completed this FDA recognized food safety trainingcurriculum or is otherwise qualified through job experience todevelop a Food Safety Plan. The preventive controls qualifiedindividualdoesnothave tobe anemployeeof the facility, but it isbeneficial for a facility to have at least one preventive controlsqualifiedindividualonstaff.

Definition:

Preventive controls qualified individual: 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.

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Theteamshouldconsistofindividualswithdifferentspecialtiesandexperience with the facility’s processes and procedures. The foodsafetyteamshouldincludememberswhoaredirectlyinvolvedwiththe plant’s daily operations, and may include personnel frommaintenance,production (includingequipment experts), sanitation,quality assurance, engineering, purchasing and laboratory, ifapplicable.TheseindividualsdeveloptheFoodSafetyPlanundertheoversight of a preventive controls qualified individual, and verifyongoing implementation of the food safety system. The teammembers should be knowledgeable about food safety hazards andfood safety principles. When issues arise that cannot be resolvedinternally, itmay be necessary to enlist outside expertise. In smallcompanies,theresponsibilityforwritingtheFoodSafetyPlanmayfalltooneperson.Ifit ispossibletobuildafoodsafetyteaminasmallcompany, employeesknowledgeableof various functions, includingowners, should be members of the food safety team. Universities,cooperativeextension,consultinggroupsandtradeassociationscanprovide additional assistance through model plans, publishedguidanceand,insomecases,personalassistance.

InadditiontowritinganddevelopingtheFoodSafetyPlan,thefoodsafetyteamprovidesoversightoftheimplementationoftheplaninthe daily operations of the facility. This includes ensuring thatappropriatepeoplearetrainedtohandletheirrequiredduties.

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Example

Throughouttheclassafictionalfrozenomeletmanufacturer,theE.G.Food Company, is used to provide an example. The above is adescriptionofthis fictitiouscompany,withsomeinformationabouthowtheorganizationoperates.Thisdescriptionhelpsyouvisualizetheoperation.

E.G.FoodCompany’sfoodsafetyteamconsistsoffouremployees–theplant manager, the quality assurance manager, the productionsupervisor and the sanitation supervisor. All have undergone foodsafetytrainingandusereferencessuchasFDAguidancedocuments.Additionally,theyuseanexternalfoodsafetyconsultanttoassistwithdevelopmentoftheFoodSafetyPlan,annualreviewand,asneeded,for changes. They also use recommendations from their chemical

This is from the Food Safety Plan on page A3‐3.

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supplier on appropriate cleaning and sanitation compounds andprocedures for theirsanitationcontrols.Adescriptionof their foodsafety team in their Food Safety Plan is above. This is optional.Appendix3:FoodSafetyPlanExamplecontainsthefullFoodSafetyPlan,whichwillbeusedforexamplesthroughoutthecourse.

2. Describe the Product and Its Distribution

Understanding basic information about a product and how it isdistributedisneededtodetermineifspecificcontrolsareimportanttoensurethesafetyoftheproductthroughoutthedistributioncycle.The food safety team should describe the product(s), the type ofpackaging, shelf life expectations, and the method of storage anddistribution. Information on factors that can influence growth ofpathogens(e.g.,pH,wateractivity,preservatives,ifany)isusefulforproductsthathaveintrinsicpropertiesthatcontrolpotentialgrowthofbacteria. Itisimportanttounderstandtheseelementstoidentifythe potential food safety hazards that need to be addressed bypreventivecontrols. AProductDescription formhasbeendevelopedtohelprecordthisinformation and is located inAppendix 2 for your review and use.Other formats may be used, rows may be deleted and a simpleparagraph format is also acceptable. The Preventive Controls forHumanFoodregulationdoesnotmandatecapturingthisinformationortheformat;however,theinformationcontainedinthisformcanbeuseful to provide an overview of the product to an independentauditor(e.g.,whenanauditisrequiredbyacustomer)orafoodsafetyconsultant who is helping you to develop a Food Safety Plan. Theinformationmayalsobeuseful in theevent thata recall isneeded.FDAguidanceonrecall submissionrecommendsprovidingproductinformationsuchastheproductname(andnumber)anddescriptionsuchastheform,intendeduse,expectedshelflife(ifperishable)and

Elements of the product description and distribution, as well as the information on consumers and intended use (discussed in the next section) are listed in a table on page 6‐8.

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the type of packaging (See Chapter 15: Recall Plan for moreinformation).

3. Describe the Intended Use and Consumers of the Food

Intendeduseoftheproductreferstoitsanticipatedusebyend‐users(e.g.,otherfoodprocessors,consumersetc.).Mostfoodsarelikelytobe intended for the general public. The food safety team shouldconsiderthesequestions. 1) Whatistheintendeduseoftheproduct (e.g.,retail,foodservice,

furtherprocessing)2) Whatisthepotentialformishandlingandunintendeduse 3) Whathandlingandpreparationproceduresarerequiredofthe

endusers Forexample, istheproductready‐to‐eat,ordoesitrequirefurtherpreparationsuchasreheating,cookingetc.

4) Whoaretheintendedconsumersoftheproduct 5) Is the product intended specifically for use by immune‐

compromisedindividualsorothersusceptiblegroups

Answeringthesequestionsprovidesvaluableinformationforthefoodsafety teamas theyproceed to thehazard analysis (seeChapter8:HazardAnalysisandPreventiveControlsDetermination).

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The intended consumersmay be the general public or a particularsegmentofthepopulationthatismoresensitivetocertainhazards.Theseat‐riskgroupsinclude:

x Infantsandyoungchildren–Infantsandyoungchildrendonothavea fullydeveloped immunesystemandaremore likely todevelopcertaintypesoffoodborneillnessessuchasinfectionsbybacterialpathogens.Chokinghazardsfromthefooditselforpackagingmaterial(e.g.,smallcaps)mayalsobeaconcernforthisgroup.

x Elderlypersons–Aspeopleage,theirimmunesystemsnaturallyweaken. Elderly persons tend to be more susceptible toinfections by foodborne bacterial pathogens than the generalpopulation,andillnessesmayalsobemoresevere.

x Pregnant women – Some pathogens, such as ListeriamonocytogenesandToxoplasmagondii,areparticularlyharmfulto the developing fetus. Foods targeted specifically towardpregnant women should control potential sources of thesepathogens.

x Immune‐suppressed persons – Other factors can weaken theimmune system. For example, persons who are HIV positive,have had organ transplants, are undergoing cancerchemotherapy or have taken other immunosuppressive drugtherapies are particularly susceptible to developing illnessescausedbyfoodbornepathogens.Asmodernmedicaltreatmentsimprove, it is important to consider that a relatively largepercentageofthepopulationfitsinthiscategory.

Whilefoodtargetedtothegeneralpopulationmaybeconsumedbythese vulnerable groups, food specifically designed for susceptible

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populations (e.g., for hospitals, nursing homes) may require morestringentcontrolsbecausemostofthesefoodwillbeconsumedbyanat‐riskpopulation.

TheProductDescription,Distribution,ConsumersandIntendedUseformdescribedbelowandlocatedinAppendix2canbeusedtorecordthisinformation.Thisinformationisimportanttoassureanaccuratehazardanalysis,butisnotrequiredintherule.

Elements of a Complete Product Description and Intended Use Form

Productname(s) Mayincludemorethanoneproductwithsimilarprocessingandhazardprofile

Product description,including important foodsafetycharacteristics

A general descriptionof theproduct andprocessingmethod,assembly,andfamilyofproductsincludedinthecategory.Ifitis relevant to product safety, intrinsic properties likepreservatives,wateractivityandpHshouldbelistedhere.

Ingredients A simple listing of ingredients, which may be grouped ortransferred from theproduct label, if this is convenient. Thiscould also be an attachment (a list or a recipe) or referenceingredient specificationnumbers,whichwouldprovidemoredetailedinformation.

Packagingused A general description of the packaging, including modifiedatmosphereorvacuumpackaging,ifused.Thismayimpactthehazardsofconcern.

Intendeduse Describethenormalexpecteduseofthefood(e.g.,ready‐to‐eat,ready‐to‐cook,raw),andifuseful,whereit issold(e.g.,retail,foodservice,schools,longtermcarefacilitiesetc.).Maydescribea complex distribution system if desired; e.g., frozendistribution with refrigerated or ambient display; use forfurtherprocessing,etc.Ifunintendeduseorabuseis likelytooccur(e.g.,eatingrawcookiedough)thisshouldbeidentified.

Shelflife Listintendedshelflife,ifrelevanttopotentialmicrobialgrowth.

Labelinginstructions Include label instructions relevant to food safety. This mayincluderefrigeration,cookinginstructionsetc.,ifrelevant.

Storageanddistribution List the method of distribution, e.g., refrigerated, frozen,ambient.

A downloadable Product Description template is available on the FSPCA website.

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Product Description Example

Above is an example of a product description thatwill be used toillustrate the progressive development of a Food Safety Plan foromeletproductsproducedbythefictitiousE.G.FoodCompany.Notethat in this example, the potential for abuse is identified in the“IntendedUse”section.

4. Develop a Flow Diagram and Describe the Process

Aflowdiagramprovidesanimportantvisualtoolthatthefoodsafetyteamcanusetodescribetheprocess.Whendevelopingaprocessflowdiagram, it is important to include all the process stepswithin thefacility’s control, from receiving through final product storage,includingreworkanddivertedby‐product,ifapplicable.Eachprocess

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stepshouldbeconsideredindetailandtheinformationexpandedtoincludeallrelevantprocessinformation.Informationmayinclude:x Allingredientsandpackagingusedx Where raw materials, ingredients and intermediate products

entertheflowx Thesequenceandinteractionofallstepsintheoperationx Where product reworking and recycling take place in the

processx Whereproductisdivertedtowaste,ifapplicable.

TheflowdiagramfortheE.G.FoodCompanyOmeletexampleappearsbelow.

This is from the Food Safety Plan on page A3‐5.

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Awrittenprocessdescriptionisalsousefultoexplainwhathappensateachoftheprocessstepsandcancontainmoredetailthantheflowdiagram.Thisdescriptioncanbeusedasaworkingreferenceforthedevelopment of the Food Safety Plan. oumay already have otherdocuments that contain similar information, such as productspecifications,recipesorworkinstructionsthatcanbeusedinplaceofthedescriptionillustratedinthischapter.

Itisimportanttoknowwhatoccursateachprocessstep.Forexample,information such as themaximum length of time that the productcouldbeexposedtounrefrigeratedtemperatures,themaximumroomairtemperatureortheinternalproducttemperatureafteraprocessmayimpactfoodsafety,thusitisimportanttoknowforanaccuratehazardanalysis.

ThebeginningoftheprocessdescriptionfromtheE.G.FoodCompanyexampleappearsabove.SeeAppendix3:FoodSafetyPlanforthefullprocessdescription.

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5. Verify the Flow Diagram

The steps in the flow diagram are used to organize the hazardanalysis, which is discussed in Chapter 8: Hazard Analysis andPreventiveControlsDetermination.Sincetheaccuracyoftheprocessflowiscriticaltoconductahazardanalysis,thestepsoutlinedinthechartmustbeverifiedattheplant. Ifastepismissed,afoodsafetyhazardrequiringapreventivecontrolmaybemissed.Includeeveryhandling, processing and holding step for the product, as well asingredientsandpackaging.Thefoodsafetyteamshouldwalkthroughthefacilityandmakeanychangesrequiredintheflowdiagram.Atthesametime,theteamshouldmakeobservationsrelatedtosanitation,potential for cross‐contamination or allergen cross‐contact, andpotential harborages or introduction points for environmentalpathogens.Thewalk‐through allows each teammember to gain anoverallpictureofhowtheproductismade.Itmaybehelpfultoinviteadditional plant personnel to review the diagramduring thewalk‐through. Many times operators can identify issues that may beoverlookedbymanagementor the foodsafety team.Thecomplete,verifiedflowdiagramshouldberetainedandperiodicallyevaluatedasafoodsafetyrecordandpartoftheFoodSafetyPlan.Asignatureisusuallyusedtoindicatethattheflowdiagramhasbeenverified.

FoodSafety Plans aredynamic andmustbe updated to reflect anychanges in process or food safety considerations. Therefore, anysignificantchangestotheprocessmustbeaccuratelyreflectedintheproduct flow diagram, and the Food Safety Teammust evaluate ifthesechangeshaveanimpactonthehazardanalysisandpreventivecontrolsinplace.

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Preliminary Steps Summary

It is important to have the right people in place, and informationavailable on the ingredients, packaging and processes used beforeapplyingpreventivecontrolsprinciplestodevelopaFoodSafetyPlan.Preliminarystepsinclude:

1) assemblingthefoodsafetyteamandensuringthattheyhavemanagementcommitmentandadequatetrainingtoperformanaccurateassessmentofthefoodsafetyhazardsthatexistfortheproductsbeingproduced,

2) preparing an accurate description of the product and itsdistributiontounderstandthecharacteristicsoftheproductandensurethatpotentialhazardsarenotoverlooked,

3) identifying the intended use and consumers to ensure thatpreventivecontrolsusedwillprotectthesafetyofconsumersduringintendeduseandacknowledgepotentialmisuseoftheproduct,

4) creating a process flow diagram that provides theorganizationalframeworkforconductingthehazardanalysis,which identifies preventive controls to prevent food safetyrisksfortheconsumingpublic,and

5) Verifying the flow diagram and operational conditions toavoidoverlookingsourcesofpotentialhazards.

IfafacilityproducesmorethanoneproductandseveralFoodSafetyPlansareneeded,itisrecommendedthatthefoodsafetyteamkeepitstasksimplebyonlyattemptingtodeveloponeplanatatime.Theteam could have the first plan reviewed by a third party beforeaddressing additional plans. This canhelp to ensure they correctlyidentifythehazardsrequiringpreventivecontrols.

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Additional Reading FAO/WHO.2003.HazardAnalysis andCriticalControlPoint (HACCP)Systemand

GuidelinesforItsApplicationAnnextoCAC/RCP1‐1 6 ,Rev.4‐2003FDA.2014.DairyGradeAVoluntaryHACCPNationalAdvisoryCommitteeonMicrobiological Criteria for Foods. 1 8.Hazard

AnalysisandCriticalControlPointPrinciplesandApplicationGuidelines.JournalofFoodProtection61( ):1246‐125 .

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The FSPCA website maintains a current list of resource material. Please consult this website for the latest information.

CHAPTER 7. Resources for Preparing Food Safety Plans

A successful Food Safety Plan identifies hazards requiring apreventivecontrolsandprocedurestocontrolthemtoensurethatthefoodproducedissafetoeat.Thefirstpartofthischapterintroducesnumerous resources that can assist in developing andmodifying aFood Safety Plan. The second part provides information on FDAguidancetohelpyoutoconductyourhazardanalysisanddevelopaFoodSafetyPlan.

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Chapter 7

Before implementing a food safety system, you need to perform ahazard analysis to determine which hazards require a preventivecontrolforyourproducts.ToconductahazardanalysisanddevelopaFood Safety Plan, gather information from a variety of crediblesourcesandusethe informationthatbestapplies toyoursituation.Someofthemostusefulsourcesofinformationaredescribedinthischapter.Sourcesofinformationincludepeople,publications,reliableinternetsites,miscellaneousagenciesandtheFDA.

Personnel

Your Employees ouandyour employees knowyour operationbetter than anyone.Experience is an excellent source of information. oumay alreadyhaveknowledgeabouthazardsthatcanaffectyourproduct,andyoumayalreadyhavepreventivecontrolsimplementedtocontrolthosehazards.

In addition to being a source of information, your employees areessentialforimplementingtheplan.Thisincludeseveryone,includingseniormanagement(whomustdemonstratecommitmenttoeffectivedevelopment,implementationandongoingmaintenanceoftheFoodSafetyPlan).

Consultants and Auditors Food safety consultants, firms and auditors with expertise in thePreventive Controls for Human Food regulation can be a usefulresource. Consultants may be helpful in developing and reviewingyour Food Safety Plan, particularly if you are just starting a newcompany or need expertise beyond your company’s abilities incomplyingwiththeregulation,sanitation,sampling,etc.Auditors

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thatyouhiremayidentifydeficienciesorincluderecommendationsforimprovementinthereporttheyprovide.

Process Authorities and Technical Experts Some food safety professionals have in‐depth expertise related tospecific types of foods or processes. These are sometimes calledprocessingauthorities.Theyusescientificmethodstodeterminetheproperparameters(e.g.,time,temperature,atmosphere,flowrate,aW,oxygen level, pHetc.) toprevent, eliminateor reducepathogens toacceptablelevels.Theyareakeysourceforvalidatingtheadequacyofa process to ensure that identified controls will actually work tocontrol a hazard. They can also provide technical advice fordeveloping a Food Safety Plan and implementing appropriatecorrective action procedures. The FSPCA Technical AssistanceNetwork is discussed in the upcoming section onReliable InternetSites.

University Specialists Many, but not all, Land Grant universities have specialists inCooperativeExtensionprograms.Theseprogramsprovideoutreach,educationandtechnicalassistancetoindustry.Foodsafetyextensionspecialistsandagentscanassistinidentifyingpotentialhazardsandcontrolmeasures,buttheiravailabilitymaybelimitedinsomeareasof the country. University research groups that conduct company‐specificresearchprojectsalsoexist.

Government Agencies Federal, state and local agencies may be able to assist you inunderstanding and meeting regulatory requirements. Some stateshave a food safety task force that provides training opportunitiesperiodically.Websitesandcall‐in &Aphonelinesthatprovideusefulinformationfromgovernmentagenciesmayalsobeavailable.SeethediscussioninReliableInternetSites.

Trade Associations Tradeassociationscanalsoprovideuseful information.Some tradeorganizations provide services such as consulting, educationalprogramsandpublicationsthatcanhelpidentifyhazardsandcontrolmeasures.Whilesometradeassociationinformationisavailableonlytomembers,othersprovidetechnicalguidanceandresourcesforsaleorinanopenformat(seeInternetResourcessection).

Suppliers, Buyers and Laboratory Analysts Suppliers of ingredients, cleaning materials, processing equipmentand packaging materials; and analytical laboratories can provideinformation on potential hazards and control measures. A buyer’sspecification may point to a hazard in one of your products. Forexample,abuyermayrequireSalmonella‐freeproduct.Itisimportanttonote;however,thatnotallbuyers’specifications relate

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to safety. Analysts at laboratories familiarwith food samples are agood source of information in developing validation studies andsamplingprograms.Inseekingrecommendationsfromlaboratories,itisimportantthatthelaboratoryhaveexperiencewithfoodbecausetechniquesusedinfoodanalysismaydiffersubstantiallyfromthoseusedforclinicalorenvironmentalanalyses.Publications

PublicationsareonetypeofinformationsourcethatyoumayuseindevelopingyourFoodSafetyPlan.Itisimportantthatyouusecrediblepublicationsforthispurpose.Theslideabovelistsgeneralsourcesofcredibleinformation,andeachtypeisdescribedbelow.

FSPCA Basic Course Oneofthebestandmostaccessiblefoodsafetyresourcesavailabletodevelopandmodifyapreventive‐controls‐compliantFoodSafetyPlanisthisbookprovidedintheFoodSafetyPreventiveControlsAlliancebasiccourse–theHazardAnalysisandPreventiveControlsforHumanFood training curriculum.This training curriculumcovers steps fordeveloping a Food Safety Plan using a model food designed to beconsumed by the general public. The chapters cover prerequisiteprograms;biological, chemical (includingradiological) andphysicalhazards encountered in foods and basic information on how thesehazards can be controlled; elements of process, food allergen,sanitation and supply‐chain program preventive controls; and thePreventiveControlsforHumanFoodregulation.

FDA Publications FDA’s Bad Bug Book (see link on the FSPCA website) providestechnicalinformationonfoodbornepathogensineverydaylanguage.FDAhazardsguidesforseafoodandjuiceproductsareavailable,and

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a comprehensive Food Safety Preventive Controls forHuman FoodsHazards and Controls Guidance (Food Hazards Guide) is underdevelopment.TheFoodHazardsGuidewillcontaininformationto1)help identify potential hazards and determine if they require apreventivecontrol,and2)selectapproachestocontrolthehazards.AdiscussionFDA’shazardguidesisincludedlaterinthischapter.

Peer Reviewed Literature Peer reviewed, scientific literature is another useful source ofinformation for developing a Food Safety Plan. As previouslymentioned, appropriate expertise is needed to properly applyinformation to a specific operation. The search toolGoogle Scholarmaybeusefultoidentifypeerreviewedliterature.

Trade Association Publications Tradeassociationsmaybeausefulsourceof information, includingmodelrecallplans,genericFoodSafetyPlansandotherinformation.Trade journals often provide general information on potentialhazardsandcontrols.Articlesonspecificprocessesorproductsalsocan be useful. These trade journals are usually made available toindustryatnocharge,andmanyareaccessibleonline.WhilegenericFood Safety Plans may be available for products related to youroperations,usethesewithcaution,asyourplanshouldbespecificforyourparticularproductandhowitismadeinyourfacility.

References Used in Development of Chapters Manyreferenceswereusedinthedevelopmentofthematerialinthistraining curriculum. Refer to the “Additional Reading” section ofchaptersforreferencesthatmayberelevanttoyouroperation.Reliable Internet Sites

Google Scholar is a useful tool to search peer reviewed literature.

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Informationonkeyfoodsafetyhazardsandcontrolsisavailableforfree online.WARNING: Be sure to use peer reviewed and othercrediblesourceswhenseekinginformationonthewebtoavoiduseofinaccurateinformation AfewwebsitesrecommendedbyFSPCAarediscussedbelow.Becausewebaddresseschangeandinformationmaybe removed if it becomesoutofdate, check theFSPCAwebsite forupdatedinformationandlinks.

Food Safety Preventive Controls Alliance (FSPCA) Website FSPCA maintains links to internet resources on its website andprovidesperiodicupdateswithnewsourcesofinformationwhentheyare identified.AccesstotheFSPCATechnicalAssistanceNetworkisavailable through the FSPCA website. The website also providesupdatesonFSPCAactivitiesandtrainingcoursesthatareavailable.

Food and Drug Administration (FDA) Website The FDAwebsite (www.fda.gov) provides quick access to industryguidance, bulletins for health professionals, consumer educationmaterials and other documents and data from FDA’s centers andoffices.KeyFDAwebresourcesinclude:

x FDA’sFSMATechnicalAssistanceNetwork,whichprovidesanswerstopolicyinterpretationquestions

x FDAGuidanceforFoodsx FDAOutbreakInvestigationsx FDARecalls,MarketWithdrawalsandSafetyAlertsx FDAReportableFoodRegistry

FDA’s FSMA Technical Assistance Network, which provides answers to policy interpretation questions

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US Agency Resources x TheCentersforDiseaseControlandPreventionisresponsible

for characterizing risk factors and prevention strategies fordiseases that impact public health. The CDC also assists localhealth agencies in epidemiological investigations of foodborneillness outbreaks. Certain diseases are reported to the CDC bystate epidemiologists. CDC information canprovide insight intothe outbreaks associatedwith specific food types. Examples ofusefulCDCwebsitesforFoodSafetyPlandevelopmentinclude:

x Multistate Foodborne Outbreak Investigations – Reportsinvestigations of multistate outbreaks involving food andothersources

x Foodborne Outbreak Online Database (FOOD) – SearchabledatabaseforU.S.outbreaks

x Attribution of Foodborne Illness – Reports on foodsassociatedwithillness

x FoodSafety.gov is a gateway to government food safetyinformation, including links to foodborne pathogens, industryassistanceandgovernmentagencies.

x The U.S. Department of Agriculture (USDA) Food SafetyInspection Service (FSIS) provides food safety information andmaybeasourceofinformationonprocesscontrols,studiesandprevalenceofpathogensinUSDA‐regulatedproducts.USDAFSISalsohasinformationonrecallsthatmaybeoninterestforcertainproductcategories.

International Agency Resources Manyagenciesaroundtheworldprovidescience‐basedinformationonfoodsafetyandpotentialhazards.Afewexamplesarelistedbelowforeasyreference.Keep inmindthatspecificrequirementsmaybedifferent fromone country to another, thus informationused fromthesesitesmayrequireadjustmentstocomplywithFDAregulations.

x TheCanadianFoodInspectionAgencyprovidesinformationonfood safety for a variety of food categories, including genericHACCPmodelsforseveralproducts.

x TheCodexAlimentariusCommissionissponsoredbytheFoodandAgricultureOrganizationandtheWorldHealthOrganizationof the United Nations. Its purpose is to facilitate internationaltrade by establishing uniform standards. The commission hasdeveloped many standards and guidelines, includingrecommendedinternationalcodesofpracticeforawidevarietyoffoodproducts.

x TheEuropeanFoodSafetyAuthority(EFSA)providesEuropeanfoodsafetyinformationsimilartothatfortheUS

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agenciesdescribedabove.LookforEFSAfoodbornediseasemonitoringandanalysisreports.

Trade Association Websites x American Frozen Food Institute provides food safety

informationrelatedtofrozenproducts.

x Grocery Manufacturers Association provides food safetytechnical guidance on specific topics on their website to shareindustrymodelpractices.Someinformationisavailableforafee;other information is available atno charge. Look for resources,researchtoolsandtechnicalguidanceandtoolsinformation.

x The Innovation Center for U.S. Dairy provides science andresearchinformationfordairyproducts.

x The United Fresh Produce Association provides food safetyinformationspecifictoproduce.

FDA Hazards and Controls Guidance

FDA has published hazards and controls guidance for seafood andjuice products. These documents represent FDA’s currentunderstanding on hazards and controls for these products. FDA isdevelopingFoodSafetyPreventiveControlsforHumanFoodHazardsandControlsGuidance (FoodHazardsGuide) for foodsubject to thepreventivecontrolsregulation.

Although the Food Hazards Guide was not available when the 1steditionoftheFSPCAtraininglaunched,selectinformationintheFDA’sotherhazardsguidesmaybeapplicabletootherfoodproducts.Forexample,chaptersfromtheSeafoodHazardsGuidethatmaybeusefulinclude:

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Chapter12:Pathogenicbacteriagrowthandtoxinformation(otherthanClostridiumbotulinum)

Chapter13:ClostridiumbotulinumtoxinformationChapter14:Pathogenicbacteriagrowthandtoxinformation

asaresultofinadequatedryingChapter 15: Staphylococcus aureus toxin formation in

hydratedbattermixesChapter16:Pathogenicbacteriasurvivalthroughcookingor

pasteurizationChapter 18: Introduction of Pathogenic Bacteria after

PasteurizationandSpecializedCookingProcessesChapter 1 : Undeclared Major Food Allergens and Certain

FoodIntoleranceCausingSubstancesandProhibitedFoodandColorAdditives

Chapter20:MetalInclusionChapter21:GlassInclusion

SectionsoftheJuiceHazardsGuidemaybeusefulforprocessorsthatmakefruitorvegetableproducts,orpackinmetalorglasscontainers.For example, this guide includes discussion of pathogens thatmayoccur inacidic juices (pHd4.6)versus those in low‐acid juices (pH4.6), allergens and food intolerance substances added to juice asingredients,pesticideresidues,leadandtinhazards,glassfragments,metalfragments,hazardsrelatedtofacilitysanitationandcontrolsforallergensarisingfromfoodcontactsurfaces.

KeepinmindthattheterminologyusedinboththeSeafoodHazardsGuideandtheJuiceHazardsGuidediffersfromthatusedforpreventivecontrolsregulation.Becausethescientificbasisforconductinghazardanalysisanddeterminingeffectivecontrolsforthosehazardsinvolvesthe same process, the information provided can be useful. Therecommendations included in FDAHazards Guides are not, for themostpart, bindingFDA requirements.Useof thehazardsguides indeveloping Food Safety Plans is not mandatory. Processors andimportersarefreetochooseothercontrolmeasuresthatprovideanequivalent levelof safety assurance than those listed in theguides.Theremayalsobecircumstanceswhereahazardidentifiedinaguidemay not apply to a product because of conditions specific to theprocessor.

Subsequent chapters illustrate how information in the HazardsGuidescanbeusedtomakedecisionsanddevelopaFoodSafetyPlan.

Additional Reading SeetheFSPCAWebsite for linkstomanyofthereferencedlistedinthischapter.

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NOTES:

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CHAPTER 8. Hazard Analysis and Preventive Controls Determination

Followingthepreliminarysteps,thenextstepindevelopingaFoodSafety Plan is to identify the food safety hazards requiring apreventive control. This depends on the food, the ingredients, theequipment,thefacilitylayoutandotherelementsofthefacility’sfoodsafety system.Once thehazards requiring apreventive control areknown,preventivecontrolscanbeidentifiedtohelpensurethesafetyof the product. Keep in mind that while many different types ofcontrols may be applied when processing a food, “preventivecontrols” are risk‐based and focus on the hazards that present thegreatestrisktofoodsafety.Itisimportanttoidentifythesehazardsfirst toallowresourcesto focusonthepreventivecontrolsthatareessentialtoreducefoodsafetyrisks.

The Preventive Controls for Human Food regulation includesdefinitionsforseveraltypesofhazards.Theseinclude:

x Hazard: Anybiological, chemical (including radiological), orphysicalagentthathasthepotentialtocauseillnessorinjury.

x Known or reasonably foreseeable hazard: A biological,chemical (including radiological), or physical hazard that isknowntobe,orhas thepotential tobe,associatedwith thefacilityorthefood.

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x Hazardrequiringapreventivecontrol:Aknownorreasonablyforeseeablehazardforwhichapersonknowledgeableaboutthe safe manufacturing, processing, packing, or holding offoodwould,basedontheoutcomeofahazardanalysis(whichincludesanassessmentoftheseverityoftheillnessorinjuryifthehazardweretooccurandtheprobabilitythatthehazardwilloccurintheabsenceofpreventivecontrols),establishoneor more preventive controls to significantly minimize orpreventthehazardinafoodandcomponentstomanagethosecontrols (such as monitoring, corrections or correctiveactions,verification,andrecords)asappropriatetothefood,the facility, and thenatureof thepreventivecontroland itsroleinthefacility’sfoodsafetysystem.

Theregulationalsodefines“preventivecontrols”asfollows:x Preventivecontrols:Thoserisk‐based,reasonablyappropriate

procedures, practices and processes that a personknowledgeable about the safe manufacturing, processing,packing or holding of food would employ to significantlyminimizeorpreventthehazardsidentifiedunderthehazardanalysis that are consistent with the current scientificunderstanding of safe food manufacturing, processing,packagingorholdingatthetimeoftheanalysis.

Conductingacompleteandaccuratehazardanalysisisoneofthemostdifficult but important steps in developing an effective, risk‐basedFood Safety Plan. Systematic and thorough analysis of potentialhazards and their consequences helps to ensure that all hazardsrequiringapreventivecontrolareidentified.

Occasionally a thorough hazard analysis may identify a situationwhereanewly identifiedhazardexistsand isnotbeingadequately

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controlled. For example, several years ago scientists demonstratedthat E. coli O157:H7 tolerated higher levels of acid than otherpathogens. Reviewing the hazard analysis for some fermentedproducts suggested that formula or process adjustments wererequiredtoensurethatE.coliO157:H7wasdestroyed.

Aproperhazardanalysiscanalsofocuslimitedresourcesonthemostimportant controls. Improper hazard analysis can result in anineffective Food Safety Plan if a hazard thatmust be controlled isoverlooked.Conversely,animproperhazardanalysismayidentifytoomany controls for hazards that are not reasonably likely to causeillnessorinjury,whichresultsinasystemthatcannotbeeffectivelymanagedbyavailableresources.

For this course, hazard analysis is defined as indicated above. Thepurposeof thehazardanalysis is todevelopa listofpotential foodsafetyhazardsandthendeterminethehazardsrequiringapreventivecontrolbecausetheyarereasonablylikelytocauseinjuryorillnessinthe absence of control. Once these hazards are identified, thenpreventivecontrolsthatareessentialtopreventillnessorinjurycanbedetermined.Only thosehazards thatposearisk to thehealthofconsumers should be included in the Food Safety Plan. Not allpotential hazards require a preventive control in an individualoperation.

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How to Conduct a Hazard Analysis

A sequenceof steps is followed to complete a hazardanalysis, andeachoftheitemslistedaboveisdiscussedinthischapter.Thehazardanalysis process is based on the information organized in thepreliminary steps discussed in Chapter 6: Preliminary Steps inDeveloping a Food Safety Plan, such as the ingredients and rawmaterials; activities at each process step; product storage anddistribution; and final preparation and use by the consumer.Essentiallytheinformationprovidedthroughthepreliminarystepsisaroadmapforconductingthehazardanalysis.

A Hazard Analysis Form can be used to ensure that all steps areanalyzed and the results are documented. The form also lists thehazards requiring a preventive control and identifies the type of

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control tobeapplied.Other formats, including formats thatarenotform‐based (e.g., a written narrative) may be used as long as thehazardanalysisisdocumentedandcontainstheelementsofhazardidentification,hazardevaluationandpreventivecontrolsselection.Ajustification for decisions should be provided so others canunderstandthebasisforthedecisions.Inthiscourse:

x Column1isusedtolisteachoftheprocessstepsfromtheflowdiagram; including the receiving of each raw material oringredientusedintheprocess(somemaybegrouped).

x Column 2 (hazard identification) is used to list all rawmaterial‐, ingredient‐, process‐, and environment‐relatedhazardsidentifiedforeachstep.Thehazardstoconsiderarediscussedbelow.

x Column 3 is a simple “ es or No” that states whether thehazardrequiresapreventivecontrol.

x Column4(hazardevaluation)isusedtojustifyyouranswersinColumn3 (and sometimes inColumn2 if nohazardwasidentifiedbuttheteamhadalotofdiscussionaboutit).

x Column5isusedonlywhenthereisa“ es” inColumn3toidentifythepreventivecontrolsthatsignificantlyminimizeorpreventthehazard;e.g.,process,allergen,sanitation,supply‐chainorotherpreventivecontrols.

x Column6isusedtodocumentifthepreventivecontrolwillbemanagedatthatstep.

Keep in mind that other formats may be used. The slide aboverepresents twoadditional formatsandothersmaybeusedaswell.Model plans posted on the FSPCA website illustrate additionalformats.Makesurethattheformatthatyouuseisunderstoodbyyour

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teaminyourfacilityandthatitaddressesallergen,sanitation,supply‐chainandotherpreventivecontrolsasapplicabletothefacilityandfood.

Set Up the Hazard Analysis Form Column 1 – List Process Steps and Incoming Ingredients and Materials

WewillusetheE.G.FoodCompanyomeletexampletoillustratethehazardanalysisprocessandcompleteahazardanalysisform.Setupthehazardanalysisformbyenteringthefirm’snameandaddress,thenameof theproductorproductnumber(s), thedate theanalysis iscompletedandifit isarevisionofapreviousanalysis,thepreviousdatetokeeprecordsorganized.Aseparateworksheetmaybeneededfor each product type, but grouping products may be done if thehazards and controls are the sameor if anydifferences are clearlydelineated.WehavegroupedallofE.G.FoodCompany’somelets inthishazardanalysis.

Aprocessflowchartwasdevelopedaspartofthepreliminarysteps(Chapter6).ListeachoftheprocessstepsinColumn1ofthehazardanalysisworksheet.Thisistheframeworkthatguidesdevelopmentofthishazardanalysis.Oneofthefirststepsfromtheflowdiagramisillustratedintheslideabove.ThefullHazardAnalysisisinAppendix3:FoodSafetyPlanExample.

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Column 2 – Hazard Identification

Thehazardidentificationisbasicallyabrainstormingexercisewherethe team generates a list of potential (“known or reasonablyforeseeable”) biological, chemical (including radiological) andphysical food safety hazards thatmay be introduced, increased orcontrolled at each step described on the product flow diagramdeveloped in Chapter 6: Preliminary Steps in Developing a FoodSafetyPlan.Theprocessofhazardidentificationshouldconsider:

x Thepreliminary information collectedwhiledeveloping theproductdescription.

x Experience within the facility on the likelihood of hazardsbeingpresent in finishedproductsbasedonproducttestingresults,consumercomplaintsorothermeans.Theteammayalso rely on its knowledge of the facility, including layout,receivingandotherprocessesthatcanbeusedtodeterminewheretheproductisvulnerabletocontamination.

x External information, including scientific papers,epidemiologicalstudiesandotherhistoricaldata forsimilarproducts,ifavailable.

x Informationfromthefoodsupplychainonfoodsafetyhazardsthat may be relevant for the end products, intermediateproductsandthefoodatthemomentofconsumption.

x Information from applicable government or industry foodsafetyguidancedocuments.

Hazardidentificationconsidersthosepotentialhazardsthatmaybepresentinthefoodbecausetheyoccurnaturally,orhazardsthatmaybeunintentionallyintroduced,orinrarecircumstanceshazardsthatmaybeintentionallyintroducedforpurposesofeconomicgain.

The U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) report on “Hazard Analysis and Critical Control Point Principles and Application Guidelines” contains a useful set of questions to consider when conducting hazard identification. See Additional Reading.

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oumaywishtoincludelinesonyourformtoensurethateachofthethreetypesofpotentialhazardsisconsideredintheanalysis:

x Biological (B)hazards, includingbacteria,viruses,parasites,andenvironmentalpathogens

x Chemical (C) hazards, including radiological hazards, foodallergens, substances such as pesticides and drug residues,naturaltoxins,decomposition,andunapprovedfoodorcoloradditives

x Physical (P) hazards, including potentially harmfulextraneous matter that may cause choking, injury or otheradversehealtheffects.

These hazard types were discussed in Chapters 4: Biological FoodSafetyHazardsand5:Chemical,PhysicalandEconomicallyMotivatedFoodSafetyHazards.Assessingtheproductwithrespecttoeachofthehazards in Chapters 4 and 5, as appropriate to the food and yourfacility, can be one approach to identifying which of them arereasonablyforeseeableandthusappropriateforfurtherevaluationtodetermine if they require a preventive control. The FDA HazardsGuides include “potential process‐related hazards” tables that listpotential hazards that are associated with a variety of finishedproduct forms and package types. When using this table, it isimportanttoreviewalloftheentriesto lookforthebestfit fortheproductbeingconsidered.Notethatyourproductmayfitinmorethanonecategory.

TheFoodHazardsGuidedoesnotidentifyallhazardsforallprocessesand isnotanexhaustive list.Thus it isrecommendedthatyoualsoperformanon‐siteassessmentand look for information that isnotidentifiedintheFoodHazardsGuidetables.Thiscanhelpyoutoavoidoverlookingahazardthatcouldnegativelyimpactproductsafety.

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Columns 3 and 4 – Hazard Evaluation

Following identification of hazards, the food safety team decideswhichofthepotentialhazardsidentifiedpresentarisktoconsumerssuchthatitrequirespreventivecontrols.Thisincludesconsiderationofthe:

x Severityoftheillnessorinjuryandx Likelihoodofoccurrence.

Columns3and4areconsideredatthesametimeonthisform.Someorganizations may add additional columns to capture separatediscussiononseverityandlikelihood.

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Manyfactorsshouldbeconsideredwhenhazardsareidentified.Forexample:

x Formulationof the foodmay result inpH,water activity orotherconditionsthatfavorgrowthofcertainpathogensandpreventgrowthofothers(discussedindetailinChapter4).

x The condition, function and design of the facility andequipmentmayenhancethepotentialforcontaminantstobeintroduced.Sometypesofequipmentmaybemoredifficulttoclean than others or more prone to wear or damage (e.g.,metal fragments),whichcouldresult inan increasedriskofhazardsbeingintroducedintotheproduct.

x Ingredients and raw materials from your suppliers mayintroducehazards,suchasfoodallergensorpathogensknowntobeassociatedwithspecifictypesoffoods.Waterandiceasingredients, and compressed air used in the food (e.g., foroverruninicecream),couldbeconsideredhereorcouldbeconsideredattheprocessstepsinwhichtheyareused.

x Transportation practices may influence the potentialpresence of pathogens. Bulk transportation may be moreprone to potential contamination than packaged producttransport. Ingredients that are transported underrefrigerationmaybesubjecttotemperatureabusethatcouldincrease the risk of growth of certain hazards. Frozentransportmayreducerisk.

x Processingprocedureslikecookingmayreducesomehazards(e.g.,vegetativepathogens).Otherprocessingproceduresmayincreasethepotentialforsomehazards,(e.g.,metalchopperblades contactinghardmaterialsmaybreakandpotentiallycontributemetalhazards).

x Packaging and labeling can influence hazards of concern.Labelingofallergensortheneedforspecialstorageconditions(e.g., keep refrigerated) may help to reduce the risk toconsumers. Also, reduced oxygen packaging may increaseshelflifebutmayalsocreateanenvironmentthatsupportsthegrowthofC.botulinumorL.monocytogenesforsomefood.Thepotential for thesehazardsmustbe considered for reducedoxygen packaging. Storage and distribution conditionsmaysuggestpreventivecontrolsareneededifpathogengrowthisapotentialproblem.However,thismaynotbeafoodsafetyconcernifproductsareshelfstable.Considerationshouldalsobegivento thepotential for the food tobecontaminated inshipment;e.g.,bulkcargoes.

x Someproductsareintendedtobecookedorfurthertreatedprior to consumption, which may reduce risk for theconsumer. However, it is prudent to consider how the endusermayusetheproductsinotherways(i.e.,foreseeableuse).Forexample,rawcookiedoughisintendedtobecookedpriortoconsumption;however,productssuchascookiedoughice

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cream have been marketed as a ready‐to‐eat product. Theformulation and processes for ready‐to‐eat dough must becarefully considered to avoid potential food safety issuesbecausetraditionalcookiedoughmayuseraweggs,uncookedflour and other ingredients thatmay contain pathogens. Inaddition,itiswell‐knownthatsomeconsumerseatrawcookiedough.

x Thesanitaryconditionsof theequipment,environmentandemployee hygiene are also a consideration forrecontaminationofcertainproducts.Dothesameemployeeshandle both raw and cooked product Do ready‐to‐eatproduct linescomeincloseproximitytorawproduct lines Howoftendosurfacesneedtobecleanedtoavoidgrowthinthesystem Allofthesequestionsandmoremayinfluencetheriskofcreatinghazardsforcertainproducts.

x Otherrelevantfactorsmayincludeingredientcategoriesthathave been implicated in food safety issues related tointentional product adulteration for economic gain (e.g.,additionoflead‐containingdyestocertainspicestoenhancecolor)SeethesectiononeconomicallymotivatedhazardsinChapter 5: Chemical, Physical and Economically MotivatedHazards.

Evaluating the Severity

Theseverityofafoodsafetyhazarddependsonanumberoffactorsthatmayincludehowlonganindividualissick,whethersymptomsaremildorsevere(e.g.,whetherhospitalizationordeathiscommon),whetherthereisfullrecoveryorhealthissuespersistforlongperiodsoftime,andwhetherthefood’stargetedconsumerisamemberofavulnerable population such as infants, children, the elderly or theimmunocompromisedasdiscussedinChapter6:PreliminaryStepsin

Appendix 4: Foodborne Pathogen Supplementary Information provides information on severity of common foodborne pathogens. Consider external assistance if you do not have the technical expertise to evaluate the severity of food safety hazards.

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Developing a Food Safety Plan. The severity of different hazards isdiscussed in Chapter 4: Biological Food Safety Hazards, Chapter 5:Chemical,PhysicalandEconomicallyMotivatedFoodSafetyHazards,and in more detail in Appendix 4: Foodborne PathogenSupplementary Information. Some facilitiesmayhave the expertisenecessarytomakesuchevaluations.Othersmayneedtoseekoutsideassistance to complete this step. The bottom line is thatwhen thehazard,ifpresent,isreasonablylikelytorenderthefoodinjurioustohealth,itshouldbeincluded.

Evaluating the Likelihood of Occurrence

Theotherfactorthefoodsafetyteammustevaluateisthelikelihoodofoccurrenceofthefoodbornehazard.Itisimportanttoknowhowfrequently the potential hazard may occur to determine if apreventive control is needed. In addition to food safety referencebooks, sources of data and information to consider include pastoutbreaks, recalls, the scientific literature and establishmentexperience.Regulatoryguidance,tradeassociationinformation,anduniversityextensiondocuments alsoprovideuseful informationonthe likely occurrence of hazards in particular foods. Chapter 7:Resources for Food Safety Plans discussed many sources ofinformationforidentifyingandevaluatingfoodsafetyhazards.

Pastoutbreakspresentatremendoussourceofinformationregardingthehazardsthatarelikelytooccurincertainfoodproducts.TheFoodSafetyTeamshouldtakeintoaccountlessonslearnedfromtheseprioreventsinsimilarproducts.Thenotionthat“ithasneverhappenedtous”shouldnotbeareasonforexcludingahazardifsimilarproductshavehadanissuewithaspecifichazard.FDAprovidesinformationforthefoodsthatFDAregulatesontheirfindingsrelatedtooutbreaks,frequentlydiscussingthefactorsthatcontributedtotheoutbreakataprocessingorproductionfacility.TheCDChasawealthofinformation

Consider outbreaks in similar products and product recall lists to see if similar products are on the list.

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onoutbreaksthatoccurrednotonlyfromprocessedfoods,butalsofoods prepared in restaurants, retail establishments and otherlocations. The CDC information covers not only FDA‐regulatedproducts, but also products regulated by USDA (e.g., meat andpoultry)andthoseregulatedbystateandlocalagencies.Outbreaksthat occur in other countries may also be relevant to consider,especiallyforimportedfoods.

Food recalls are a useful source of information on the potentialpresenceofhazardsinspecificfoodproducts.Itisimportanttonotethatnotallrecallsareassociatedwithfoodborneillnessoutbreaks.

x ClassIrecallsinvolveproductsthatarelikelytocauseseriousadversehealthconsequencesordeath;

x Class II recalls involve products that may cause illness orinjurybut theprobabilityof serioushealth consequences isremote;and

x ClassIIIrecalls involveproductsthatarenot likelytocauseillnessorinjury.

Federal and state government websites post information on foodrecalls.Itmaybeusefultoinvestigateinformationonthesewebsitestoseeiftheproductyouaremakinghasbeeninvolvedinrecalls.

A standard reference book can provide basic information on foodsafety hazards. Peer‐reviewed scientific journal articles and othersources of technical literature contain a wealth of information onfoodbornehazards,theiroccurrence,potentialgrowthinfoods(inthecaseofbiologicalhazards)andtheircontrol.Ausefulsearchtool isGoogle Scholar, which may be used to find the specific papers ofinterest.Microbialmodeling programs such as the USDA PathogenModelingProgramorComBaseareavailableon‐lineandcanbeusedtoexplorethepotentialforgrowthunderavarietyofconditions.Keepinmindthatthesemodelsmaynotreflectexactlywhatwilloccurinaparticular food, but they can indicate relative risk of differenthandlingscenarios.

The Codex Alimentarius Commission maintains internationallyrecognizedcodesofpracticethatarebasedonscientificliteratureandavailable in several languages. Trade associations also providerecommendations targeted to specific types of foods and industryneeds.

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The establishment may have information on the likelihood ofoccurrenceofhazardsintheirfoodproducts.Thisinformationcanbegleaned from previous laboratory tests on finished products,ingredients, in‐process materials or environmental monitoringsamples. Consumer complaint records can be a useful source ofinformation,particularlyforphysicalhazards.

Various factors can influence the likely presence of food safetyhazards,including:

x Effectivenessofplantoperationalprogramssuchasreceiving,storageandpersonalhygiene

x Frequencyofassociationofthepotentialhazardwiththefoodoringredient

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x Methodofpreparationx Conditionsduringtransportationx Expectedstorageconditionsx Likelypreparationstepsbeforeconsumption

Hazards requiring a preventive control in one operation or facilitymay not require one in another producing the same or a similarproduct.Forexample,theprobabilityofmetalcontaminationmaybehighinonefacilitybutnotinanotherduetodifferencesinequipment.Theeffectivenessofapreventivemaintenanceprogramcanalsoberelevant in determining the likelihood that ametal hazardmay bepresent.

For example, Facility A may have a comprehensive preventivemaintenanceprogramthatroutinelyinspectsandtightensequipmentnutsandboltstopreventthemfromfallingintoproduct.Theymaycouplethisprogramwithareviewprocessforequipmentdesigntoavoidinstallationofequipmentwithabrasivemetal‐on‐metalcontact.They may be able to determine that their prerequisite preventivemaintenanceprogrameffectivelymanagesthehazardofmetalintheproductbecauseoftheirhistoryofnotfindingmissingboltsandlackofobservingwornmetalinequipment.Conversely,FacilityBmaynothavesuchprograms.Itmayoccasionallyfindmissingnutsthatcouldhavefallenintotheproductstreamandmetal‐on‐metalcontactmayoccuronsomeequipment.TheymayincludemetaldetectionintheirFoodSafetyPlantoinvestigatefindingswhen“kickouts”occur.Bothapproachesarereasonable.

Another example may be a facility that does not pack in glasscontainers;prohibitsglassinthefacilityincludinginstrumentgaugeswith glass faces andwatches (even for visitors) in the productionarea;andusesshieldsonlightfixturestopreventbreakage.Theymaydetermine that glass does not require a preventive control.Conversely,afacilitythatdoesnothavetheresourcestomanagesucha program or that packs in glass may conclude that the hazardpresentedbyglassrequiresimplementationofpreventivecontrols.

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In theexampleabove, “vegetativepathogenssuchasSalmonella” isidentified as a potential hazard in egg ingredients because of thehistory of outbreaks associated with egg products. Egg is alsoidentified as a potential allergen hazard because egg can cause anallergic reaction in some consumers. Column 3 is marked “ es”indicating that a preventive control is required and Column 4providesajustificationofthedecision.Noadditionalinformationisneeded for physical hazards because no potential hazards wereidentified.Thefacilitycouldenterinformationinthejustificationfieldif desired, such as a comment that they switched from metalcontainerstobag‐in‐boxtoremovemetalconcerns.

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Columns 5 and 6 – Preventive Controls

HazardsrequiringapreventivecontrolbasedonahazardanalysisfortheirseverityandlikelihoodofoccurrencemustbeaddressedintheFood Safety Plan. The term “preventive controls” is defined in thePreventive Controls forHuman Food regulation as indicated above.Note that thedeterminationofapreventivecontrol is “risk‐based,”must be “reasonably appropriate” and “consistentwith the currentscientificunderstanding.”Keep inmind that thespecificpreventivecontrolmanagementcomponents(e.g.,monitoring,correctiveactionsand verification) required takes into account the nature of thepreventivecontrolanditsroleinthefacility’sfoodsafetysystem.

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For each “ es” in Column 3, preventive controls that significantlyminimizeorpreventthehazardmustbedescribed. Ifnoknownorreasonably foreseeable hazard is identified (Column 2 for physicalhazardsabove)orifColumn3isanswered“No,”thenColumns5and6areleftblank.Factorstoconsiderinyourdecisionmakingprocessaredescribedbelow.

Dependingonthehazardsidentified,preventivecontrolsmayincludesomeorallofthepreventivecontrolslistedonthisslide.Specifictypesofpreventivecontrolsarediscussedinchapters later inthecourse,but a brief description follows. Preventive controls identified atspecific processing steps are process preventive controls, such ascritical control points (CCPs, see Chapter : Process PreventiveControls). Allergen preventive controls (see Chapter 10: FoodAllergen Preventive Controls) include the essential allergenmanagementproceduresidentifiedinthehazardanalysis.Similarly,sanitation preventive controls are those specific sanitationprocedures used to control the hazards identified as requiringsanitationpreventivecontrolsinthehazardanalysis,andmayincludepreventingcontaminationofready‐to‐eatfoodsthatdonotreceiveafinal“killstep”orpreventingallergencross‐contact(seeChapter11:Sanitation Preventive Controls). Supply‐chain program preventivecontrols(seeChapter12:Supply‐chainProgram)maybenecessarywhen a manufacturer relies on the supplier to control a hazardrequiringapreventivecontrolinaningredientbecausethereceivingfacilitydoesnothaveasteptocontrolthehazard.Whilearecallplanisnotusedtomanagehazardsrequiringapreventivecontrol,itcanreduce the number of illnesses if contaminated product is recalledquickly.Otherpreventive controlsmaybeneeded, suchashygienetraininginsensitiveoperations.

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Apartiallistofpotentialpreventivecontrolmeasuresforbiological,chemical(includingradiological)andphysicalfoodsafetyhazardsarelisted in the slide above. For biological hazards, common controlmeasures include those that either directly kill the pathogen (e.g.,different types of thermal processing, irradiation, high pressureprocessing)orpreventthegerminationofsporesand/orgrowthofmicrobial vegetative cells (e.g., formulation parameters such asacidification, fermentation, drying, and a variety of time andtemperaturecontrolssuchascooling,refrigerationandlimitingtimeattemperaturesthatsupportgrowth).Supply‐chainprogramsmayberelevant, especially if ingredients are used in ready‐to‐eatapplications.Sanitationpreventivecontrolsmayalsoberelevantforready‐to‐eatproductsthatareexposedtotheenvironment.

Preventive controls for chemical hazards include supply‐chainprograms such as testing and rejection of ingredients that containexcess concentrations of natural or artificial chemical hazards.Allergenlabelingisanotherallergenpreventivecontrol.Preventionofallergen cross‐contact through sanitation may be considered anallergenorsanitationpreventivecontrol,orboth.

Physical hazards can be controlled by methods such as usingequipment forstrainingoraspirating,mechanicalseparation,metaldetection,orx‐rayorotherdetectionmethods.Thesemaybeprocesspreventivecontrols.

Preventivecontrolsforhazardsintroducedbecauseofeconomicallymotivatedadulterationmayrequireasupply‐chainprogramorsomeofthemethodsabove,dependingonthespecifichazard.

The term “sensitive ingredient” refers to an ingredient with a history of association with a pathogen when controls are not in place.

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The foodsafety teammustconsidermany factorswhen identifyingpreventive controls for the food safety hazards requiring them.Selectionofpreventivecontrolsshouldalsoincludeassessmentswithregardto:

x itseffectonidentifiedfoodsafetyhazards,x itsfeasibilityformonitoring,x itsplaceinthesystemrelativetoothercontrolmeasures,x significantprocessingvariabilityorthelikelihoodoffailureof

acontrolmeasure,x theseverityofconsequencesincaseofafailure,x whether the controlmeasure is specifically established and

applied to eliminate or significantly reduce the level ofhazards,and

x synergisticeffectsbetweencontrolmeasures.

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TheexampleaboveillustratesthehazardanalysisdecisionsforonestepintheE.G.FoodCompany’sFoodSafetyPlan.Processcontrolatasubsequentstep(cooking)wasidentifiedasthepreventivecontrolforSalmonellaineggs.Sincetheeggsarepasteurized,thecompanycouldhavechosenasupply‐chainprograminstead;however,theymayhaveconcludedthatitwaseasierforthemtomanagethecookstepthanasupply‐chain program. The decision is theirs in this situation. Anallergenpreventivecontrol toensureappropriate labelingwasalsoidentified as a preventive control. Preventive controls for both ofthesehazards(Salmonellaandegg‐allergen)areappliedlaterintheproductionprocessinthisexample.

The food safety team, with the assistance of outside experts ifnecessary,mustdeterminethespecificpreventivecontrolsneededtocontrolthehazardsrequiringthem.Aspreviouslymentioned,otherformatsforthehazardanalysismaybeusedaslongastheessentialcontrolsforhazardsrequiringapreventivecontrolaredocumentedand implemented. More than one hazard requiring a preventivecontrolmaybeaddressedbyaspecificpreventivecontrolmeasure,e.g., a cook stepmay address both Salmonella andE. coli O157:H7hazards.

For those familiar with HACCP food safety systems, keep in mind that not all preventive controls are CCPs. The actions that are taken for other preventive controls may be different from those required for CCPs. This is discussed in Chapters 9‐12 on specific preventive controls.

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Summarize the Hazard Analysis

At the completion of the hazard analysis, the food safety teamdocuments the results of the hazard analysis process. A review ofwhatisdocumentedinthedifferentcolumnsforthemodelformusedinthiscourseispresentedabove.Otherformatsmaybeused,aslongastheyclearlyidentifythepotentialhazards,evaluatethelikelihoodandseverityof therisk,and identifypreventivecontrolmeasure(s)thatareusedforallhazardsthatarereasonablylikelytocauseillnessorinjuryintheabsenceofapreventivecontrol.

Hazardsrequiringapreventivecontrolmustbemanagedthroughuseof process preventive controls, allergen preventive controls,sanitation preventive controls, supply‐chain programs or otherpreventive controls as appropriate for the food and facility.Operationsorequipmentinafacilitymayneedtobemodifiedbasedonthefindingsofathoroughhazardanalysis.Ifthehazardanalysisdetermines that a knownor reasonably foreseeable (i.e., potential)hazardislikelytobepresentwithoutapreventivecontrolmeasure,then the product formulation, processing steps, other plantoperations or supply‐chain programs must be modified to ensurecontrol of the hazard. Alternatively, there is provision for thepreventivecontroltobeappliedlaterinthedistributionofproduct.Thisisdiscussedinpreventivecontrolschapters.

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TheE.G.FoodCompany’sPlainOmeletHazardAnalysisinAppendix3isanexampleofhowahazardanalysiscouldbedocumented.Inourexampleform,thestepfromtheflowdiagramisrecordedincolumn1.Incolumn2,potentialhazardsthatmaybeintroducedorincreaseatthisstepareidentified.Itispossiblethatapotentialhazardisnotahazard requiringapreventive control – thedecision is recorded incolumn3.Recordingtherationaleforthedecisionsmaderegardinghazardsandpreventivecontrolsisusefultoexplaintoothershowthedecisionwasreached–thisisdoneincolumn4.Forhazardsrequiringapreventivecontrol(a“ es”incolumn3),thepreventivecontrolthatneedstobeimplementedisidentifiedincolumn5.Column6identifiesifthepreventivecontroloccursatthisstep.Itmayoccurlaterintheprocessandthatstepwouldbemarkedasapreventivecontrol.

The full hazard analysis for the fictitious E.G. Food Company’s omelets is in Appendix 3: Food Safety Plan Example. This appendix also includes a description of the process at each step to help visualize how this operation functions.

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Hazard Analysis for Several Products

Acommonhazardanalysismaybeusedforagroupofproductsthatare similar in formulation, have similar processing steps, and areotherwisepreparedandpackagedinasimilarmanner.Forexample,thehazardanalysisandFoodSafetyPlanfortheE.G.FoodCompanygroupsthreedifferentomeletsintoonehazardanalysisandoneFoodSafety Plan. It is important to note, however, that differentformulationscanhaveadramaticimpactonproductcharacteristics(e.g., pH, different allergens), and these factors must be carefullyconsidered in the hazard analysis. While the E.G. Food Companygroupstheomeletsinthesamehazardanalysis,othercompaniesmaywishtoaddressthecheeseomeletbiscuitinaseparateplanbecauseofthewheatallergeninthebiscuitandtheextraassemblystep.TheFoodSafetyTeammustorganizetheinformationinameaningfulwaytocommunicatethesignificantriskstothestaffatthefacility.

Forreasonsdiscussedpreviously,thehazardanalysisandFoodSafetyPlanwilllikelybedifferentforthesameproductproducedindifferentfacilities. The food safety teammust take into account the uniquecharacteristics, equipment and procedures used at theirestablishmentwhenpreparingtheFoodSafetyPlanspecificfortheirfirm. However, it is perfectly reasonable for the team to refer togeneric HACCP or preventive control models, hazards and controlguides, and decision trees to help them with their deliberations.Generic Food Safety Plans, however, will rarely consider all of thespecific aspects in an actual facility, thus they are for teaching orguidancepurposesonly.SourcesofgenericHACCPplans(whichcouldserveas a startingpoint for aFoodSafetyPlan) and resources arelistedinAdditionalReadingattheendofthechapter.Otherhazardanalysis models and decision trees may be available from otherreputable sources. As a word of caution, these resources may not

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consider hazards associated with sanitation, allergens and supply‐chainprogramstotheextentrequiredforFoodSafetyPlansunderthePreventiveControlsforHumanFoodregulation.

Pulling It All Together

The hazard analysis process identifies those hazards requiring apreventive control because they are knownor reasonably likely tocause illness or injury in the absence of a preventive control. Thepreventivecontrolsneededtomanagethesehazardsmaybespecificcontrolsintheprocessand,frequentlymanagedasCCPs.Theymaybespecific sanitation preventive controls to manage environmentalpathogens or allergen cross‐contact. Allergen preventive controlsmay also include production run sequencing and product labeling,whichisdiscussedinChapter10:FoodAllergenPreventiveControls.Some hazards requiring a preventive control need supply‐chainprogramstoverifycontrolofthehazardbythesupplier.Finally,theneedforotherpreventivecontrolsmaybeidentifiedthroughhazardanalysis,suchastemperaturecontrolduringtransportation.

ThehazardsrequiringapreventivecontrolintheE.G.FoodCompanyexamplearesummarizedbelow.

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Inthehypotheticalomeletexample,twoprocesspreventivecontrolswere identified: cooking the omelet to inactivate vegetativepathogensandmetaldetectiontopreventmetalcontaminationoftheproduct.

Theexampleillustratesthreeallergenpreventivecontrolsidentified:

1. ensuring that labels received from the printer accuratelydeclaretheallergensintheproduct

Some companies may have only one preventive control for allergen labeling – when the label is placed on the package. Others may use two: 1. to check for errors on

incoming batches of labels by an individual knowledgeable in label requirements and

2. to check that the correct label is place on the product. Each facility determines the best approach for their situation.

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2. controlling the potential for allergen cross‐contact at theAssemble,Wrapstep;and

3. ensuring that the correct product labeling with relevantallergensisputontheproduct.

Somecompaniesmayconsiderthelabelingstepasaprocesscontrolif,forexample,theyuseabarcodescannertomonitorproperlabelapplicationormanuallycomparea labelandformulationeachtimenewlabelsareaddedtotheline.Thisisuptothespecificoperation.

Twosanitationpreventivecontrolswereidentified:

1. prevent the potential introduction of environmentalpathogensattheAssemble,Wrapstep,and

2. preventallergencross‐contactatthesamestep.

Sanitation of the Assemble, Wrap table would be the appropriateprocedure to prevent allergen cross‐contact. Hygienic zoning andsanitation procedures in the Assemble, Wrap environment wouldlikely includemore than just cleaning and sanitizing the assemblytable. This is discussed in more detail in Chapter 11: SanitationPreventiveControls.

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Inthehypotheticalomeletexample,onepreventivecontrolfortheirsupply‐chainprogramwasidentified,i.e.,forthepasteurizedprocesscheese used in the omelets. E.G. Food Company does not have anyprocessthatwouldcontroltheidentifiedhazards,thustheyrelyonthe supplier to control the pasteurization process to destroyvegetativepathogensandformulationtocontrolC.botulinum.Theymanagethisthroughtheirsupply‐chainprogrambyrequiringathirdparty audit. Thedetails onhow theyobtain information froma3rdpartyauditarediscussedinChapter12:Supply‐chainProgram.Together,process,allergen,sanitationandotherpreventivecontrolsincludingsupply‐chainprogramsgreatlyminimize thepotential fortheE.G.FoodCompanyomeletstocauseanillnessor injuryfortheconsumingpublic.

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Hazard Analysis and Preventive Controls Determination Summary

Hazards are biological, chemical or physical agents that have thepotential to cause illness or injury. The hazard analysis processidentifiesknownorforeseeablehazardsthatareknowntobeorhavethepotentialtobeassociatedwiththefacilityorfooditmakes.Thesepotentialhazardsarethenevaluatedtoassesslikelihoodandseveritytodetermine,basedonrisk,thosehazardsthatrequireapreventivecontrol.

Through thisprocess,aneffectivehazardanalysis reducesriskandfocuses implementation efforts on the preventive controls andassociatedproceduresthatarethemostimportantcontrolsforfoodsafety. A poorly executed hazard analysis may overlook hazardsrequiringapreventivecontrol,ormayidentifytoomanycontrolsthatreallyarelessimportantforsafety,thusmakingtheFoodSafetyPlanunmanageable.

Awrittenhazardanalysisisrequired.Engagingtechnicalexpertsmaybeusefulforthehazardanalysistoensurethatthehazardsrequiringa preventive control and appropriate preventive controls areidentified.

Additional ReadingFDA.2014.DairyGradeAVoluntaryHACCP.FDA. 2016.Food SafetyPreventiveControls forHumanFoodHazardsandControls

GuidanceNationalAdvisoryCommitteeonMicrobiological Criteria for Foods. 1 8.Hazard

AnalysisandCriticalControlPointPrinciplesandApplicationGuidelines.JournalofFoodProtection61( ):1246‐125 .

SeafoodInformationResourceCenter.2014.

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CHAPTER 9. Process Preventive Controls

ProcesspreventivecontrolsmakeupthepartofyourFoodSafetyPlanthatfocusesoncontrolsrequiredatprocessstepsthatarecriticalforthe safety of the food. Process preventive controls requiredocumentationofparametersandminimumormaximumvalues(e.g.,critical limits) associatedwith the control, monitoring procedures,correctiveactionproceduresandvalidationthattheprocesscontrolsthehazard.Therequirementsforprocesspreventivecontrolsdependon the role of the process control in the food safety system. Thischapterprovides informationon establishing values forprocessingparameters(e.g.,critical limits),howtomonitorprocesspreventivecontrols,andcomponentsofcorrectiveactionstobetakenforprocesspreventivecontrolswhendeviationsoccur.

Link to Hazard Analysis Process preventive controls include parameters and usually limits(maximum or minimum values) associated with the control of ahazard. These science‐based values are quite specific and arecommonlycalledcriticallimits.Theyareappliedatprocessingstepsthatare frequentlycalledCriticalControlPoints(CCPs).ACCPis“apoint, step,orprocedure ina foodprocessatwhichcontrol canbeappliedandisessentialtopreventoreliminateafoodsafetyhazardorreducesuchhazardtoanacceptablelevel.”Onceaprocesspreventivecontrol,suchasaCCP,isidentifiedforaspecifichazard,parametersandvaluesthatcanbeusedtocontrolthehazardmustbeestablished.

Definition:

Critical Control Point (CCP): A point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. ‐ 21 CFR 117.3

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Keepinmindthattherequirementsforprocesspreventivecontrolsdependontheroleoftheprocesscontrolinthefoodsafetysystem.

Avarietyofformatscanbeusedtodocumentthisinformation.Thiscourseusestheformatabove,whichincludesinformationthatmustbe documented in the Food Safety Plan. Details on informationrequired on Food Safety Plan records are discussed in Chapter 14:Record‐keepingProcedures.

As illustrated above, the steps identified as requiring a processpreventivecontrol,includingCCPs,alongwiththehazardsrequiringapreventivecontrolaretransferredbythefoodsafetyteamfromtheHazardAnalysisFormtothefirstandsecondcolumnsoftheProcessControl Form. This form may be referred to as a HACCP Chart ifdesired.Thefoodsafetyteamthenlistsparametersandcriticallimits

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(theminimumormaximumvaluesassociatedwiththeparameters)forthecontrolsforeachhazard,allelementsofmonitoring,correctiveactions to be taken when deviations from the critical limit occur,verification procedures and records in subsequent columns. Thischapter discusses critical limits, monitoring and corrective actionelementsof theProcessControlForm.Elementsofverificationandrecord‐keepingrequirementsareaddressedinseparatechapters.

Parameters and Values such as Critical Limits

For simplicity, the term “critical limit” is used in the rest of thischapterinsteadof“minimumormaximumvaluesassociatedwiththeparameters tocontrol thehazard.”Critical limitsplayan importantroleinapreventivecontrolprogram.Ifahazardexists,itisimportanttounderstandvaluesfortheparametersthatmustbemettocontrolthathazard.Thischapterfocusesonhowtoestablishscience‐basedcritical limits that help to assure process control. Sources ofinformationonlimitsarereadilyavailable,andthesewillbediscussedlaterinthechapter.Thechapteralsodiscussesdifferentoptionsusedto establish a critical limit, as well as the advantages anddisadvantages of these approaches. More conservative “operatinglimits” (e.g., higher or lower temperatures than needed for safety)maybeusefulduringproductiontominimizefailuretomeetacriticallimit and may be set for meeting quality standards. Finally, thechaptershowshowtobegintocompleteaProcessControlForm.

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For most process‐related preventive controls, measurableparameters can be identified and the values established for theseparametersarecalledcritical limits,definedbytheslideabove.Thecritical limit must be met at the process control (or CCP) tosignificantlyminimizeorpreventthehazardrequiringapreventivecontrol.Ifacritical limit isnotmet,thestepisoutofcontrol(i.e.,adeviationhasoccurred)andthepotentialforproducingaproductthatpresentsaconsumer‐healthriskexists.

Examples of parameters that may have critical limits identifiedincludetime,temperature,flowrate, linespeed,productbeddepth,weight, viscosity, moisture level, water activity, salt concentration,pH,andothers,dependingupontheprocess.

The FSPCA Website has a list of resources and links that may be useful for a company to determine critical limits appropriate for their product.

Appendix 4 of this manual also has some information that could be used for critical limits for biological hazards.

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Anumber of sources of scientific and technical information canbeuseful in establishing critical limits, as discussed in Chapter7:ResourcesforFoodSafetyPlans.FDAandothergovernmentagenciesmay provide information through technical staff, regulations,guidelines,directives,performancestandards,tolerancesandactionlevels. Trade associations, process authorities, industry scientists,university and extension scientists, and consultants can provideexpertiseandguidelines.Scientificstudies forspecificproductscanbeconductedin‐house,atacontractlaboratoryoratauniversity.

Information can also be obtained from peer reviewed scientificliterature.Usecarewhenapplyinginformationfromthesesourcestocritical limits for a specific product and process. There may beimportantdifferencesbetweenthemethodsusedinapublishedstudyandthoseusedfortheproductandprocessunderconsideration.Thecriticallimitsmayneedtobeadjustedtoaccountforthosedifferences.For example, higher fat levels may have a protective effect in themicrobial lethalityofaheat treatment,whichmayrequireahighertemperature or a longer time to achieve the same level of killcomparedtoalowerfatproduct.

Becauseofthepotentialsafetyimplications,meetingcriticallimitsataCCPisessential forthesafetyoftheproduct.Becauseofthis, it isimportant that the critical limit can be achieved by the process. Acriticallimitisgenerallyexpressedasaparameterequaltoorabove(or below) a critical value and not at the specific value itself. Forexample,processingequipment couldnoteasilymaintain theexactvalue of 160 F (71 C) so the critical limit would be set at 160 F(71 C). This allows theCCP to be achieved and gives the option ofexceedingit,sayforbeingmoreconservativeortooperateatahigherprocessing limit. Many times, different options can be applied ascritical limits to control a specific hazard. The food safety team

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decides the best option for the particular CCP, taking into accountpracticalconsiderationssuchastheprocesscapabilitiesinquestion,how measurements can be made, staff capabilities and otherappropriatefactors.

Therearemanydifferenttypesofcriticallimits.TheymustbespecificfortheCCPandthehazardthatisbeingcontrolled.Differentcriticallimits may be needed for ingredient‐related hazards and process‐relatedhazards.EachCCPmusthaveone(ormore)criticallimitforeach food safety hazard, as illustrated in the examples above. Aneffectivecritical limitdefineswhatcanbemeasuredorobservedtodemonstrate that the hazard is being controlled at that CCP. Forexample,bothtimeandtemperaturemeasurementsmaybeelementsofacriticallimittoeliminatefoodsafetyhazardssuchaspathogensatacookstep.

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Facilities may have different options for controlling a particularhazard.Theselectionofthebestcontroloptionandthebestcriticallimit(s)isoftendrivenbypracticalityandexperience.Asillustratedintheslideabove,critical limitsmay involveanumberofparameterssuchastime,temperature,airflow,productweightorthickness,andthelike,dependingonthenatureoftheproductandtheprocess.Somefacilitiesmaychoosetouseahigherairflowandareducedthicknessinthedriedproductexampletoachievetheendpointmorequickly.These parameters must be determined on a product‐ by‐productbasis,andconsidertheroleofthecontrolinthefoodsafetysystem.

Critical Limit Options

A variety of approaches couldbe applied to set critical limits for acookingCCPintendedtoeliminatethehazardofvegetativepathogens

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in a frozen omelet. In the example above the product temperatureachieved during cooking is set as the critical limit. However, theproducttemperaturemaynotbeeasytomonitorforeachindividualproductcooked.Heattransferratesduringcookingcouldalsovaryforseveralreasons.Forasauce,measuringtheproducttemperaturemaybepracticalbecausetheliquidcouldbemixed.Foraproductlikeanomelet,aprocedurewouldneedtobedevelopedformeasuringthetemperatureofanomelet.Ifitisabatchprocess(e.g.,bakedinasetofpans),thismaybeworkable.However,ifeachomeletisindividuallymade, itmay be less practical tomeasure temperature and recordtemperaturebecausethetimefordonenessmayvaryfromoneomelettothenext.Onewouldneedmoreassurancethatthecriticallimitismetforeachindividualproduct.

Exceptinlimitedcircumstances(e.g.,theproductisaliquidsuchasmilkinapipeoracontinuouslystirredliquidproduct),itseldomispractical to continuallymonitor the temperatureof each individualfood product on a processing line to ensure conformance with acritical limit. As an alternative, the example above establishesconditionsnecessarytoensurethatthecookingprocessachievestheminimumproducttemperatureandtime.Inthisapproach,theoventemperature,thebeltspeedgoingthroughtheoven,andthevolumeofbatterplacedintostandardpansareallfactorsthataffectthefinaltemperature. These parameters are easy to monitor andmeasurementsareobtainedquicklytodeterminethatcriticallimitshavebeenmet.Ascientificstudy(validation,discussedbelowandinChapter 13: Verification and Validation Procedures) must beperformed to ensure that controlling these factors at the specifiedcritical limitswillalwaysresult inan internalproduct temperaturethatwilldestroypathogensofconcern.Typically,thisoptionprovides

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better assurance and may be easier to perform than the previousoption,eventhoughmoreparametersmustbemonitoredatthisstep.

Critical Limit Example

TheE.G.FoodCompany’shazardanalysisdescribedinthepreviouschapteridentifiedtwoCCPs,including1)theCookstepand2)Metaldetection.

Cook:ThisisaCCPforinactivationofvegetativepathogenssuchasSalmonella.Inthisoperation,eachomeletisindividuallycookedbyanoperator. Based on validation studies (see Chapter 13: Verificationand Validation Procedures) the Food Safety Team determined thecritical limit for this CCP:Omelet temperature is 158°F (70°C)instantaneousbeforetransfertoassemblytable.

ThiscriticallimitisenteredintheProcessControlForm.

Metaldetection: This step is a CCP formetal thatmay have beenintroduced earlier in the process. The food safety team identifiedmetaldetectionasaCCP,withthecriticallimits:1)Metaldetectorpresent and operating and 2) nometal fragments thatwouldcauseinjuryorchokingareintheproductpassingthroughthemetaldetector.

ThiscriticallimitisenteredintheProcessControlForm.

It is essential that the critical limit selected actually controls theidentifiedhazard Thisrequiresapplicationofsciencetovalidatethatthecontroliseffective.TheprocessofvalidationisdiscussedfurtherinChapter13:VerificationandValidationProcedures,whichincludesan example of a validation study conducted for the E.G. FoodCompany.

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Monitoring

Thissectioncoversthedefinitionofmonitoring,aswellasexplainingwhyitisimportant.Considerationsfordesigningamonitoringsystemare discussed, as well as different methods that can be used.Monitoring is a preventive controls management component thatappliesnotonlytoprocesspreventivecontrols,butalsotoallergenandsanitationpreventivecontrols,asappropriatetothecontrolanditsroleinthefacility’sfoodsafetysystem.

Monitoring involves the selection of appropriatemeasurements orobservationsataspecifiedfrequencytoprovideinformationtoassesswhetheracontrolmeasureisoperatingasintended.

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The purpose of monitoring is to document that the minimum ormaximumvalues,suchasacriticallimit,foraparameterhavebeenmet, thus ensuring the food safety hazard has been controlled.Monitoring also provides data to document that products wereproducedinaccordancewiththeFoodSafetyPlan.ItisimportantthatmonitoringproceduresarespecificfortheparameteridentifiedintheFood Safety Plan. When monitoring shows that the minimum ormaximumvalues,suchasacriticallimit,foraparameterarenotmet,acorrectiveactionisneeded,whichisdiscussedlaterinthechapter.

Monitoring requires four elements: 1) what measurements orobservations will be used to monitor, 2) how to conduct themonitoring, 3)what frequencywill be used formonitoring, and4)whowilldothemonitoring.

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Monitoringprocesspreventivecontrolsdependsonthenatureofthecontrolanditsroleinthefacility’sfoodsafetysystem.Itmayinvolvemeasuringacharacteristicoftheproductorprocesstodetermineifacritical limit is met. Examples of monitoring measurements couldinclude:

x Cold‐storage temperature when the refrigeration unittemperature is the parameter forwhich a critical limit hasbeenestablished.

x Line speed and cooker temperature when cook time andtemperature are parameters for which critical limits havebeenestablished.

x ThepHresultingfromaddinganacidifyingingredientwhenpH is a parameter for which a critical limit has beenestablished.

x Processparameterssuchaslinespeed,flowrate,beddepthorsimilar elements if these have been established duringvalidationascriticaltocontrolthehazard.

x Observingthatthemetaldetectorisonwhenmetalisahazardofconcern.

x Checking that the sizing bar that controls thickness byrejectingoversizeunitsisinplaceifthicknessisaparameterimportantforheatpenetration.

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Differentmethodscanbeusedtomonitorcriticallimits,dependingonthe nature of the control. Thesemethodsneed to be real‐time andaccurate.Theyshouldalsoconsiderifthereare“worstcase”locations,likecoldspots,thatmustbemonitored.Ifyouareusingmonitoringinstruments in the wrong way or in the wrong location, then theobjectiveofmonitoringislikelynotbeingmet.

Usingcalibratedinstrumentstomeasureacriticallimitparameterisan effective way to conduct monitoring. Examples of monitoringinstrumentscould include thermometers,pHmeters,wateractivitymeters,dataloggers,etc.AdiscussionofcalibrationoccursinChapter13:VerificationandValidationProcedures.

Monitoringmethodscanalsoinvolvevisuallycheckingwhatyouaremonitoring.Whenusingvisualobservation,itmustbeclearwhetheror not a critical limit has been violated. In our omelet example, aproductionemployeeobservesthatthemetaldetectorisonandthattherejectdeviceisworking.Theemployeerecordstheseobservationsatthebeginning,middleandendoftheshift.

Monitoring should be designed to provide rapid, real‐time results.Some laboratorymethods are relatively quick and can be used fordecision making. For example, pH measurements are useful tomonitor fermentation processes. Viscosity measurements may beuseful forprocessesthatrequirespecific flowcharacteristics foraneffectiveheattreatment.Brixmeasurements,moisturecontent,wateractivity,antimicrobialconcentrationmeasurementsandothertypesoftestsmayhaveapplicationinaFoodSafetyPlan.However,lengthyanalyticaltests(suchasmanymicrobiologicaltests)arenotusefulforroutinemonitoring because critical limit failuresmust be detectedquickly and an appropriate corrective action instituted beforeproductisshipped.

The concept of “real time” laboratory methods is evolving. Ideally it provides immediate results. Sometimes there is a delay of seconds to minutes. It could also include a longer time if the product remains in process or on hold until results are in in for decision making.

Tests that take longer can still play a role in preventive controls through verification procedures. See Chapter 13: Verification and Validation Procedures.

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When possible, continuousmonitoring procedures should be used.Continuousmonitoringisgenerallyperformedbyaninstrumentthatproducesacontinuousrecord.Theserecordscanbeeitheraffirmativerecords demonstrating temperature is controlled or “exceptionrecords”demonstrating lossoftemperaturecontrol(Seediscussionbelowonexceptionrecords).Therecordneedstobecheckedbyanindividualperiodically toensure that thecritical limit isbeingmet.The length of time between checks directly affects the amount ofreworkorproductlossthatmayoccurwhenacriticallimitdeviationisfound.Examplesofcontinuousmonitoringcouldinclude:

x The time and temperature data for a batch pasteurizationprocessmay be continuouslymonitored and recorded on atemperature‐recordingchart.

x The temperatureof a storage coolermaybe “continuously”monitoredandrecordedbyaninstrumentatapredeterminedtimeinterval.

x A functioning metal detector automatically monitors allproductthatpassesthroughit.

x Oxidation/reduction potential (ORP) is recordedcontinuouslybyacalibratedautomatedprobeinavegetableflume.

Theproperfunctioningandautomatedrecordsgenerated,ifany,foreach of these types of systems must be monitored or verified, asappropriate(seebelowon“exceptionrecords”),byanindividualonaperiodicbasistodocumentthatthesystemisperformingasspecifiedintheFoodSafetyPlan.Forexample,theORPreadingsmaybereadtwiceashiftbyalineoperatorinadditiontothecontinuousrecord.

The term “continuous monitoring” may be interpreted differently by some. In this course, continuous monitoring can be performed by a device itself as long as a visual check of the data and/or functionality, as appropriate, is also performed to ensure that the device is functioning properly. Charts run out of ink, pens get stuck, and probes can malfunction; which is why human involvement must occur periodically.

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Inmanysituations, continuousmonitoringsystemsarenot feasiblebecausethetechnologydoesnotexist,thecostisprohibitiveorotherreasons. It is still necessary to establish amonitoring interval thatensures critical limits are met. The frequency of non‐continuous(periodic)monitoringcouldbeinfluencedbyhistoricalknowledgeofthe product and process. uestions that could help determine thefrequencyinclude:

x How much does the process normally vary (e.g., howconsistentarethedata) Ifthemonitoringdatashowagreatdealofvariation,thetimebetweenmonitoringchecksshouldbeshort.

x Howclosearethenormaloperatingvaluestothecriticallimit If the normal values are close to the critical limit, the timebetweenmonitoringchecksshouldbeshort.

x Howmuchproductisatriskifthecriticallimitisexceeded Ifalargeamountofproductisatriskandcannotbereworked,forexample,morefrequentmonitoringmaybeprudent.

Examplesofnon‐continuousmonitoringinclude:x Temperaturechecksofbatteronabreadinglineatspecified

intervalsifacontinuousmonitoringsystemisnotfeasible.x Wateractivitymeasurementsforbatchprocessoperationsx Antimicrobial chemical levels in a vegetable flume when

automatedmonitoringsystemsarenotavailable.

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Exception Records

Exceptionreportinginvolvesautomatedsystemsthataredesignedtoalert operators and management only when a deviation (in otherwordsanexception) fromtherequirement isobserved.Automatedexception reportingmay bemore efficient than that performed byoperators,allowingincreasedsamplingfrequency(oftencontinuous)and reduction of human error. For example, refrigerationtemperaturecontrolcannotifyonexception(e.g.,hightemperaturealarm)andmayonlyrecordtemperaturesthatexceedthespecifiedtemperature. Such systems must be validated and periodicallyverified to ensure they are working properly. With such systems,monitoring recordsmay not always be necessary,when validationandperiodicverificationareconductedtoensurethatthesystemisworkingproperly. Therefore, records of refrigeration temperatureduring storage of food that requires time/temperature control tosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogensmaybeaffirmativerecordsdemonstratingtemperatureis controlled (e.g., a chart recorder) or exception recordsdemonstratinglossoftemperaturecontrol(e.g.,analarmsystemthatrecords when a deviation occurs). If a facility uses “exceptionrecords,”thefacilitymusthaveevidencethatthesystemisworkingasintended, such as a record that the systemhasbeen challengedbyincreasingthetemperaturetoapointatwhichan“exceptionrecord”is generated. Exception records may also be adequate incircumstances other thanmonitoring of refrigeration temperature,suchasmonitoringforforeignmaterialwithx‐rays,whichresultsinarecordonlywhenthesystemdetects foreignmaterial.Validation isrequired.

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Individuals assigned to preventive controls monitoring activitiesmustreceivetrainingappropriateforthetask.Theycanbe:

x Linepersonnelx Equipmentoperatorsx Supervisorsx Maintenancepersonnelx ualityassurancepersonnel

Monitoring by line personnel and equipment operators can beadvantageous since they are actively watching the product orequipment. Including production workers in food safety activitieshelps build a broadbase of understanding and commitment to thepreventivecontrolsprogram.

Themonitor’sdutiesshouldrequirethatalldeviationsfromcriticallimits be responded to immediately and reported as necessary toensurethatprocessadjustmentsandcorrectiveactionsaremadeinatimelymanner.Rapidresponsewhenoperatinglimitsarenotmetcanprevent critical limit deviations. All records and documentsassociated with preventive control (including CCP) monitoring,includingcorrectiveactions,mustbesignedorinitialedbythepersondoingtheactivityandthedate,and,whereappropriate,thetimeoftheactivityrecorded.

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Properly trained (“qualified”) personnel must perform monitoringrequiredbytheplan.ProcessControlFormsmustspecify“who”(i.e.,theposition)performsmonitoring.Whilethismaybeassignedtoasupervisor,make sure this is realistic for the facility. For example,supervisors are sometimes calledaway forother activities, suchasaccompanying an inspector during an inspection visit. It is notrealistictoexpectonepersontoaccompanyaninspectorandperformmonitoringactivitiesatthesametime.Itispreferabletofullyexplaintheimportanceofmonitoringprocedurestoaresponsiblelineworkerwho can maintain the records and even take immediate actionnecessarywhenadeviationoccurs.Forexample,alineworkeronafinalpackaginglinemaybetrainedinmonitoringactivitiesatametaldetector.Theindividualcaninvestigatedetectorrejections(kickouts)to determine cause, document findings, run calibration checks, etc.withoutdirectinvolvementfromsupervisors.Thispersoncouldevenshutthelinedownifissuesareidentifiedandtheninformsupervisorsformorein‐depthinvestigations.

Individuals assigned to preventive controls monitoring activitiesmust also receive food safety training on information discussed inChapter14:Record‐keepingProcedures.

Monitoring personnel (qualified individuals) are not required to be "preventive controls qualified individuals" but must receive the food safety training required by regulation and be trained to perform their assigned task.

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Monitoring Example

TheE.GFoodCompany’sFoodSafetyTeamdeterminedmonitoringprocedures for each of the two CCPs identified. The cook step isdiscussedhere.MetaldetectionisavailableinAppendix3.

Aspreviouslydiscussed,thecriticallimitforcookingtheomeletwasdetermined to be “Omelet surface temperature is 158 F (70 C)instantaneousbeforetransfertoassemblytable.”Severalelementsofmonitoring are associated with this CCP. Each omelet is cookedindividually. A A technician or designee (theWho)measures thesurface temperature (the What) with an infrared surfacethermometer(theHow)foreachcookstationfourtimespershift(theWhen)anddocumentsthisontheformbelow.

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Anexampleof amonitoring record is illustratedabove. Itprovidesspace to record the data observed during the monitoring activity.While not required, it also includes information from the ProcessControlFormtoensurethatthepersonwhoisdoingthemonitoringactivity has the most current information and knows what to do.Monitoringrecord‐keepingrequirementsarecoveredinChapter14:Record‐keepingProcedures.

Corrective Actions and Corrections

Whensomethinggoeswrong,correctiveactionsorcorrectionsmustbe performed depending on the hazard and the nature of thepreventive control. Requirements vary for process, food allergen,sanitation and supply‐chain program preventive controls. Thissection covers the definition of corrective action and corrections.

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Deviations from process preventive controls frequently requirecorrective actions, thus corrective actions are addressed in thischapter,includingbasicinformationonrecord‐keeping.

Corrective actions and corrections are preventive controlmanagement components. Corrective actions are procedures thatmustbetakenifpreventivecontrolsarenotproperlyimplemented,andinvolvedocumentationofthespecificactionstaken.Correctionsapplywhenyoutakeactioninatimelymannertoidentifyandcorrectaminor and isolatedproblem that doesnot directly impactproductsafety,suchasidentifyingafood‐contactsurfacethatwasnotproperlycleaned and re‐cleaning it prior to production. Many sanitationpreventivecontrollapsescanbeeffectivelymanagedthroughuseofcorrections. Conversely, many process preventive control lapsesrequirecorrectiveactionprocedures.

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A Food Safety Plan should be designed to ensure that critical limitdeviations are rapidly identified and corrected. When a deviationoccurs, it ispossible thatunsafeproductmayhavebeenproduced.Theactiontakeshouldbeappropriatetothenatureofthehazardandthe preventive control. Thus, in some cases, you may be able toidentify and correct a minor and isolated problem that does notdirectly impact product safety, in which case corrections may beadequate.Thesubsequentdiscussionfocusesoncorrectiveaction.

Thecorrectiveactionproceduresmustdescribethestepstobetakentoaddress thepointsnotedabove.The first requirement is to takeappropriate action to identify and correct the problem withimplementationofapreventivecontrol.Thiscouldinvolvefailuretomeeta critical limitor a verificationprocedure indicatingan issue.

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Corrective actions may also be required for certain verificationprocedures,suchasdetectionofpathogens.Processcontrolmustalsoberestored.Empowermentofemployeestostopthelinewhentheyobserveaprocessdeviationcanenhancefoodsafetyandminimizetheamount of product that will be subject to review. This requirestrainingandtrust,butcanbeveryusefultoencourageafoodsafety‐mindedculture.PredeterminedcorrectiveactionsinyourFoodSafetyPlanprovidea“how‐to”guidethatdescribesthestepstotakewhenapreventivecontrol isnotproperlyimplemented(e.g.,acritical limitdeviationoccurs).

Thesecondrequirementistotakeactiontoreducethelikelihoodthattheproblemwillrecur,whenappropriate.Rootcauseanalysismaybeuseful to determine how to prevent recurrence. Corrective actionexamples may involve equipment repair, employee training andoverallevaluationoftheprocessforimprovements.Sometimesthismay be a simple readjustment of the process, but sometimes analternateprocessisrequired.Alternateprocessesmustbevalidatedforeffectiveness.

The third requirement is to evaluate all affected food for safety.Implicatedproductshouldbesegregatedandevaluatedtodetermineif a food safety hazard exists. Product testing may or may not berequired,dependingonthenatureofthehazardandthenatureoftheprocess.

Thefourthrequirementistokeepallaffectedfoodfromenteringintocommerce unless you can ensure that the affected food is notadulterated(section402oftheFederalFoodDrugandCosmeticAct)ormisbrandedwithrespecttoallergenlabeling(section403(w)oftheFederalFoodDrugandCosmeticAct). It isbest tobe cautious, butproductdestructionmaynotalwaysbenecessary.Ifahazardexists,theaffectedproductmustbereworkedordisposed inamanner toensureitwillnotcauseconsumerillness.

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Examples of corrective action for the process include those listedaboveandothers.Sometimesanimmediateadjustmentoftheprocessmaybepossible;however,formanyprocesses,constant“tweaking”canincreaseprocessvariation,whichreducescertaintyoftheoveralleffectiveness of the process. If an immediate adjustment is madefrequently, a follow up study on the impact on the safety of theproductoverallmaybewarranted.

Aspreviouslymentioned, itmaybeappropriate foranemployeetostoptheline.Thisrequiresempowermentoftheemployeetotakethisaction.

Insomesituations,analternateprocessmayhavebeenvalidatedtobeeffectiveatcontrollingthehazard.Ifthisisthecase,suchaprocessmay be implemented as a corrective action. For example, if atemperaturedropsbelowthecriticallimit,analternateprocessthatinvolveslongertimeatalowertemperaturemaybeapplied,providedithasbeenvalidated.

Equipmentrepairsmayberequired,aswellasretrainingemployeesonproperprocedures.Insomesituations,anevaluationoftheentireoperationmayberequiredtoensure that theproduct iscapableofbeingproducedunderconditionsthatareessentialforproductsafety.

Regardingcorrectiveactionsassociatedwiththeproduct,aproducthold,howeverbrief,isessentialwhenadeviationoccursataCCPandproduct has been produced. The product must be evaluated todeterminethepotentialriskpriortomakingthedecisiontorelease,rework or destroy the product. This may include diverting theproducttoadifferentusewherethehazardisnotanissue,suchasuseasaningredientthatwillbefurtherprocessedordivertingittoanimalfood.Appropriateregulationsmustbefollowed.

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Althoughitmaynotbepossibletoanticipateall thedeviationsthatcould happen, corrective actions need to be taken and fullydocumented even when an unanticipated situation occurs.Circumstancesconsideredtobe“unanticipatedproblems”include:

x A preventive control is not properly implemented and acorrectiveactionprocedurehasnotbeenestablished;

x Apreventive control, combinationofpreventive controlsorthefoodsafetyplanasawholeisfoundtobeineffective,suchaswhen verification activities detect a pathogen in an RTEproduct.

x A review of records finds that they were not complete,activities were not conducted in accordancewith the FoodSafety Plan, or appropriate decisionswere notmade aboutcorrectiveactions.

In such cases, in addition to taking the corrective actions alreadydescribed, the Food Safety Plan (or applicable portion of the plan)mustbereanalyzedtodeterminewhethermodificationstotheplanarerequired.

Aswith other product subject to a deviation, proper and thoroughsafety evaluation is necessary to determine the disposition of theproduct.Decisionsrelatedtothedispositionoftheaffectedproductmustbebasedonsoundevidence.Thisevidencemustbedocumentedtosupportthedecision.Likeothercorrectiveactions,iftheproductisrejectedordestroyed,theprocessorneedstodocumentthatthishasbeendone.

Whether the corrective action was planned or unanticipated, apreventive controls qualified individual must conduct or overseereviewof records for theappropriatenessof thecorrectiveactions.Noteveryfirmhasanexpertonstaffwhocanevaluatethesafetyof

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products involved in a deviation. It may be necessary to identifyadditionalresourcesthatcanhelpwithproductsafetyevaluations.

First,recordsmustdocumenttheactionstakentoidentifyandcorrecttheproblemwithimplementationofthepreventivecontrolinordertoreducethelikelihoodthattheproblemwillrecur.Includedinthisrequirementisarecordoftheactionstakentofixtheproblemthatcaused the deviation and to restore process control. Evaluation ofhistorical corrective action records can help to identify recurringproblems. When critical limit deviations frequently reoccur, theprocess and the Food Safety Plan may need reanalysis andmodification. A formal process may be needed to manage majorchanges that need to be implemented. This may include reissuingforms, retraining employees, phasing in changes, managing labelinformation, informingsuppliersandother tasks,dependingonthenatureofthechange.

Second, recordsmustdocument how the safety of all affected foodwasevaluated.Specific technicalexpertisemayberequired forthisevaluation,dependingonthenatureofthedeviation.

Third,recordsmustreflectthatallaffectedfoodinvolvedinaprocessdeviationwasprevented fromenteringcommerceuntil ithasbeendeterminedtobesafe.Thisincludesidentifyingtheamountofproductinvolved in the deviation, as well as records documenting thedispositionoftheproduct.

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An example of a Corrective Action Form appears above. In somesituations,correctiveactionactivitiesmaytakeplaceinashortperiodof time. In other, more complicated situations, corrective actionactivitiesmaytakeplaceoverseveraldays,orpossibly longer(e.g.,capital improvement projects). It is important to have an accuraterecord of all corrective actions to protect both the public and theproduct. For example, failure to provide adequate rationale as towhentheincidentstartedandendedcanleadtoanexpandedrecallaffectingasubstantialamountofproduct.

Operating Limits and Critical Limits

Useofanoperatinglimitallowsthedetectionofapotentialproblembeforeacriticallimitisviolatedbecausethevaluefortheparameteris usually more stringent (or conservative) than the critical limit.

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Operatinglimitsshouldnotbeconfusedwithcriticallimits.Operatinglimitsareestablishedsothatthecriticallimitisachievedbeforetheoperatinglimit.Theprocessmaybeadjustedwhentheoperatinglimitisnotmet,whichavoidsviolatingthecriticallimit.Theseactionsarecalled processadjustments.”Aprocessormayusetheseadjustmentstoavoidlossofcontrolresultinginadeviationandtheneedtotakecorrective action. Spottinga trend toward lossof control earlyandacting on it can save product re‐work or, worse yet, productdestruction.

Operatinglimitsmaybeselectedforvariousreasons:

x Forqualityreasons– forexamplehigher final temperaturesthan are needed to kill pathogens may enhance flavor orstructure development, or may be necessary to controlorganismsthatcancausespoilage.Shelfstableacidifiedfoodspresentanexampleofaprocessinwhichoperatinglimitsareused,becausethetimesandtemperaturesrequiredtoachievecommercialsterilitygenerallyexceedthoseneededtodestroypathogensthatarepotentiallypresent.

x To avoid deviating from a critical limit – for example, aproductthatmustbeacidifiedtopH4.6forsafetymayhaveamorestringentoperatinglimitof4.4toreducethelikelihoodofexceedingthecriticallimit.

x Toaccountfornormalvariability–forexample,afryerwitha5 F(2.8 C)variabilityshouldbesetatleast5 F(2.8 C)abovethecriticallimittoavoidviolatingit.

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Theexampleaboveillustratestwoimportantpoints:

1) Operatinglimitsandprocessadjustments,and2) Criticallimitsandcorrectiveactions.

Inthisexampleofacookingprocess,acriticallimitisestablishedat165 F(74 C)anditisclearthatthetemperaturefellbelowthatlimit.Settinganoperatinglimitabovethecriticallimit, inthisexampleat167 F (75 C) could have alerted line personnel tomake a processadjustmenttobringthecooktemperaturebackabovetheoperatinglimit.Ifanadjustmentismadebeforethetemperaturedropsbelowthecriticallimit,nocorrectiveactionrecordisrequired.However,inthisexample,anadjustmentwasnotmadeuntilafterthetemperaturedropped below the critical limit of 165 F (74 C), thus appropriatecorrectiveactionsmustbetakenandacorrectiveactionreportmustbewrittenandincludedwithpreventivecontrolsrecords.

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Corrective Action Example

TheCookstepforE.G.FoodCompany’splainomelethasthefollowingcorrectiveactionprocedures:Holdproductbacktothe lastgoodcheckandevaluate rework,discard,orrelease.Determinerootcause–retrainorcorrectasappropriate.

ThisinformationisrecordedintheFoodSafetyPlan.

Process Preventive Controls Summary

Processpreventivecontrolsfocusoncontrolsatprocessstepsthatareidentifiedinthehazardanalysisasstepswherecontrolcanbeappliedtosignificantlyminimizeorpreventhazardsrequiringapreventive control. Process preventive controls are frequently

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calledCriticalControlPoints.Thespecificcontrolsdependonthenatureofthehazardandthenatureofthepreventivecontrol.

Criticallimits,i.e.,amaximumand/orminimumvaluetowhichaprocesseffectivelycontrolsafoodsafetyhazardtoanacceptablelevel must be determined at each process‐related preventivecontrol(e.g.,CCPs)identifiedinthehazardanalysis.Criticallimitsmust be validated to ensure that the values established areeffective in controlling the hazard. Monitoring procedures arerequired at each of these steps to ensure that the process is incontrol, e.g., that critical limits are met. Such procedures mustspecifywhatwillbemonitored,howitwilltakeplace,howoftenitwillbedoneandwhowilldoit.Correctiveactionsthatdescribewhat to do when critical limits are not met must also bedetermined, unless you are dealing with a minor and isolatedproblemthatdoesnotdirectlyimpactproductsafety.

Twoadditionalrequirementsforprocesspreventivecontrolsaredescribed inChapter13:VerificationandValidationProceduresand Chapter 14: Record‐keeping Procedures. Together theseelementshelptoensurethesafetyoffoodproducts.

Additional Reading CanadianFoodInspectionAgency.2010.GuidetoFoodSafetyCodexAlimentarius

HACCPDocumentsFDA.2014.DairyGradeAVoluntaryHACCP.Grocery Manufacturers Association. 2013. A Systems Approach Using Preventive

Controls for Safe Food Production, GMA Science and Education Foundation,Washington,DC.

NationalAdvisoryCommitteeonMicrobiological Criteria for Foods. 1 8.HazardAnalysisandCriticalControlPointPrinciplesandApplicationGuidelines.JournalofFoodProtection61( ):1246‐125 .

National Seafood HACCP Alliance. 2011. Hazard Analysis Critical Control Point ‐TrainingCurriculum,5thEdition

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CHAPTER 10. Food Allergen Preventive Controls

The Preventive Controls for Human Food regulation requiresdocumented food allergen preventive controls to prevent allergencross‐contactandtoensureaccurateallergenlabelingisonfinishedfood products. The need for specific food allergen controls isdeterminedthroughthehazardanalysisprocess.Thespecificallergencontrolpractices required tomanage foodallergensdependon thespecificproductandmanufacturingpractices.CommoncausesforthepresenceofundeclaredfoodallergenswerediscussedinChapter5:Chemical,PhysicalandEconomicallyMotivatedFoodSafetyHazards.TherequiredelementsofallergencontrolsinaFoodSafetyPlan,i.e.,accuratelabelingtoinformconsumersandpreventingallergencross‐contact,andtheassociatedmonitoringproceduresareaddressedinthis chapter. A short discussion on allergen testing, which is apotential verification procedure, is also discussed in the context ofallergencross‐contact.OtherelementsofverificationarediscussedinChapter13:VerificationandValidationProcedures.

This is not intended to be a comprehensive chapter on allergenmanagement,thusreferencesareprovided for further informationattheendofthechapter.

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Link to Hazard Analysis

Aswithprocesscontrols,Chapter8:HazardAnalysisandPreventiveControls Determination describes the process of evaluating foodallergenhazards todeterminetheallergenpreventivecontrols thatarerequiredtobeincludedintheFoodSafetyPlan.TheslideaboveillustratesoneofthestepsidentifiedintheE.G.FoodCompanyomeletexampleasrequiringanallergenpreventivecontrol.Biscuitshaveawheatallergen,whichisnotpresentintheirotherproducts.Thestepillustrated, “Receiving frozen ingredients – biscuits” (Column 1),identifiesthespecificfoodallergen–wheat(Column2)andconcludesthat a food safety hazard requiring a preventive control is present(Column 3). The justification (Column 4) includes two elementsrelatedtoallergencontrol:

1) theneedforallergenlabelingtoinformconsumersand2) the need to control allergen cross‐contact because other

productsdonotcontainwheat.

Column5identifiestwopreventivecontrolstoaddresstheallergenconcern:

1) allergenlabelingatotherstepsand2) sanitationtopreventallergencross‐contactatasubsequent

step.Neither of these are a CCP (they are not controlling a specificprocessing action) but both of them are preventive controls thatmust be addressed in the Food Safety Plan. The company shoulddeterminethebestlanguagetocommunicatetheneedstothepeopleperformingthetasksinvolvedinmanagingthecontrol.Focusonwhatmustbedonetocontrolthehazard,ratherthanwhataspecificstepiscalled.

The term "sanitation" may include both cleaning and sanitizing activities. Cleaning is necessary to control allergens. Sanitizing, which is intended to kill microorganisms, has little or no impact on allergens.

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As discussed in Chapter 5: Chemical, Physical and EconomicallyMotivatedFoodSafetyHazards,thefoodallergenslistedonthisslidecontributetoabout 0 offoodallergicreactionsintheU.S.TheFoodAllergenLabelingandConsumerProtectionAct (FALCPA)mandateslabeling forthesefoodallergengroupsif theyarepresent ina foodproduct, thus these are the allergens that you would identify ashazardsrequiringapreventivecontrolduringthehazardanalysisiftheyarepresentinyourproduct.Whenlabelingaproductcontainingafoodallergen,thelabelmustbespecifictotheallergentoinformtheconsumerwhohasanallergytoonefoodinagroup.Forexample,iftreenutsarepresent,thenthespecifictreenut(s)mustalsobeonthelabel. Similarly, individual species of fish and crustaceansmust belabeled.Adiscussionoflabelingispresentedlaterinthissection.

Ifallproductsproducedinagivenfacilityhaveidenticalfoodallergenprofiles, then the allergen program needs to address only properlabelingbecauseallergencross‐contactisnotanissue.Sometimesasupply‐chain programmay be necessary, depending on the sourceand complexity of ingredients used in the product. For example,almondingredientsmaycomefromafacilitythatprocessesothertreenuts; itwill be important that the supplierhas controls to addresslabeling and allergen cross‐contact. See Chapter 12: Supply‐chainProgramsformoreinformationonsupply‐chainprograms.

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Allergen Preventive Controls Requirements

Allergen cross‐contact can occur through a number of routes.Inadequate cleaning of equipment can leave residues that canintroduce allergens from the equipment surface into productmaterial. Allergen cross‐contact can also occur during or afterprocessing. For example, if two processing belts enter the samefreezer, an allergenic componentmight fall from one line onto theother.Reworkingmaterial containing foodallergens intoa formulathatdoesnothaveidenticalingredientsmayalsointroduceallergens.Ifanallergenhazardisidentified,anallergenpreventivecontrolmustaddressthesesituations.

Incorrect labeling will occur if allergen cross‐contact issues(discussed above) occur. In addition, other avenues of incorrectlabeling exist. Formulation mistakes can introduce undeclaredallergensintoaproductinanumberofways.Substitutingingredients,either intentionally or by mistake, can also lead to undeclaredallergens in theproduct. Inadvertentuseof thewrongpackagecanoccur in a number of ways. Label handling procedures and workprocesses can help to ensure that the right label goes on the rightpackage.Undeclaredallergensmayalsobepresent if an ingredientsupplier does not manage their allergens effectively or if a labelsupplier does not print label stock accurately. Chapter 12: Supply‐chain Program addresses relevant aspects of allergen control in asupply‐chainprogram.

Human error can be involved in all of the common causes ofundeclaredallergensinfoodproducts.Becauseofthis,trainingontheimportanceofallergenpreventivecontrol,includinganawarenessofthepotentialconsequencesofamistake,isanimportantprerequisiteforimplementationofaneffectiveallergenmanagementprogram.

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Allergen Cross‐contact Prevention

Allergenpreventivecontrolsmustdocumentthoseproceduresusedtopreventallergencross‐contactwhen thehazardanalysisprocessidentifies allergens as hazards requiring a preventive control.Cleaningofequipmentthatisusedtoprocessdifferentfoodallergensis typicallyapreventivecontrol.However,certainpracticessuchasschedulingandengineeringcontrols,canminimizethefrequencyofsuch cleaning, andmightbemanagedas aprerequisiteprogram.Athoroughunderstandingofwhereallergenicingredientsexistinthemanufacturingenvironment,howtheyaremanagedandwheretheyareintroducedintotheprocesscaninfluencewhetherpracticesaremanagedasaprerequisiteprogramorasapreventivecontrol.Controlof rework must also be considered and may require a preventivecontrol.Personnelpracticescanalsoimpactthelikelihoodofallergencross‐contact.

Whether or not the techniques mentioned above are a preventivecontrolorprerequisiteprogramdependsonhowthefacilitymanagestheirsystemandthecomplexityoftheirallergenconcerns.

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Equipment Cleaning

Effectivecleaningisanessentialelementinanallergenmanagementprogram.Foodcontactsurfacesshouldbevisiblycleanasastartingpointwhenproductsproducedcontaindifferentallergens.Refer toChapter 11: Sanitation Preventive Controls for information oncleaning procedure documentation requirements and Appendix 5:SanitationBasicsformoreinformationoncleaning.

Equipment, toolsandsurfacesmustbe thoroughlycleanedprior toprocessingproductthatdoesnotcontainthesameallergenprofile.Arecord that documents cleaning between products that containdifferentallergensisrequired.Thiscouldberecordedonasanitationrecordor anallergenscheduling record.Usea format that clarifieswhatmusttobedonetomeettheneedsofyouroperation.

Optional Techniques to Manage Cleaning Dedicatingspecifictoolsandequipment,suchastotes,bins,paddles,scoopsandkettles,tospecificallergenscanreducethefrequencyofallergen cleaning. Color‐coded or labeled equipment is useful.Considererectingaphysicalbarrier(e.g.,walls,curtains,partitions)between production lines in close proximity to reduce the risk ofallergen cross‐contact. Training of staff is very important forseparatingtoolsandutensilsusedwithallergens.Lineworkersmayincorrectlyidentifycolorcodesforequipmentifcolorsarenotusedina consistent manner and the importance of dedicated tools andequipmentisnotemphasized.

The regulation does not require validation of allergen cleaning, but this is strongly encouraged. Numerous allergen recalls have occurred because equipment could not be adequately cleaned to remove allergen residues.

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Verification that allergen cleaning procedures were performed isrequired by thePreventiveControls forHumanFood regulation forhazards requiring a preventive control. Many companies use astandard of “visually clean” as the primary evidence of allergencleaning.Ifyoucanseeresidueontheequipment,theequipmentisnotclean.This includes thepresenceof filmsorproteinsheen.Usecarewith non‐specific ATP and protein tests for verifying allergencleaning.Someofthesetestsarenotsensitiveenoughtodetectlevelsof protein that could cause an allergic reaction. Validated allergen‐specifictestkitsareavailableforsomefoodallergens,andcanbeusedtodetectthepresenceoffoodallergensonfood‐contactsurfacesusingswabs.Push‐throughmaterialcanalsobeevaluatedtoestablishsafetimes and volumes for such a procedure. If a surface cannot beeffectively swabbed, final rinse water can be collected and tested,assumingtheequipmentandenvironmentissuitableforwetcleaning,as discussed in Chapter 11: Sanitation Preventive Controls. Whilefinished product can be tested, appropriate action is needed ifallergensthatarenotonthelabelaredetected.

Validation of allergen cleaning is not required. However, validation may be desirable for complex equipment the first time a unique allergen is introduced on a production line, or when major changes are made to product formulation to determine if cleaning procedures need to be adjusted.

Simple‐to‐clean equipment, such as a stainless steel table top, may not need validation if the surface is visibly clean (i.e., no residue or film) when cleaning procedures are followed.

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Allergen Scheduling or Run Sequencing

Ifalineisusedtoprocessbothallergen‐containingandnon‐allergen‐containing products, the schedule sequence should run uniqueallergens toward the end. For example, vanilla ice creammight bescheduledfirst,followedbyonewithaddedpecans,followedbyonewithaddedpecansandalmonds.Ifanallergenpresentinaproductisnotpresentinthenextproductscheduledtorun,asanitationprotocolmust be executed. Sanitation activities must be robust enough toremoveallvisibletracesofanallergenresiduepriortostartingupthenextproduct. Ifpossible,only runproductswith the sameallergenprofileonthesameproductionline.

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An example of a Production Line Allergen Assessment for the E.G.FoodCompanyappearsabove.Onlyoneproduct,theCheeseOmeletBiscuit,hasauniqueallergen.Scheduling implicationsandcleaningimplicationsarenoted.

TheE.G.FoodCompanychosetomonitorrunsequencingusingtheaboveform.

Manufacturing and Engineering Controls

When engineering a production line, consider the potential forproduct crossing from one line to another. This may occur, forexample, if an overhead conveyor spills product onto a conveyorbelow. Transfer via aerosols and dustmay also occurwhenwaterspraysorairhosesareused.Engineeringsolutionsmayreduce the

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potentialfortransfer.Insomecases,physicalbarrierssuchascurtainsorwallsbetweenlinesmaybenecessarytoseparateproductstreamscontainingdifferentallergens.Thepotential forcrossovercanalsoexistincoolingwaterorfryingoilthatisreused.Becauseitisdifficulttotestcookingoilforthepresenceofallergens,themediumshouldnotbereusedunlesssophisticatedtestsdemonstratethatthereisnocarryover.

It is important todesign equipment that canbe easily cleanedandinspectedinallareaswhenproductswithdifferentallergenprofilesaremadeonasharedline.Dustcollectionsystemsshouldalsobeusedtominimize the transferof allergensbetweenprocessing lines inadustyprocessingenvironment.Socksshouldbecleanedandreplacedas necessary. When cleaning, eliminate or minimize the use ofcompressedair,asitsusemaytransferallergenicmaterialtoalreadycleaned equipment. Maintenance employees should use dedicatedtoolsinareaswithallergens,tokeepfromspreadingtheresidue.

MapssimilartothehygienemapdiscussedinAppendix6:Hygieniconing and Environmental Monitoring may be appropriate toillustrateallergenflowthroughthefacility.Thesemapsmayindicatewhereuniqueallergensarestoredorhandled.Smallcompaniesthathavealloftheiroperationsinoneroomandhandleonlyproductwithacommonallergenprofilemaynotneedsuchadiagram.

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Allergenic Ingredient Control

Amasterlistofallergenicingredientsshouldbedevelopedaspartofallergencontrol.Frequentlythiscanbemanagedbytheindividualincharge of developing and changing product formulations usinginformationfromsuppliercontinuingguarantees.Thelistneedstobekept up to date, so it is important that any change informationcommunicated from a supplier to the purchasing department, forexample, gets to the person maintaining the master allergen list.Accessibilitytothemasterallergenlistattheloadingdockishelpfulsothatallergenicmaterialscanbeplacedinsegregatedstorage.Themasterlistshouldincludethecommonnameofthefoodallergentoensure that allergens are properly identified. For example, someingredientnamesdonotdirectlyidentifytheallergenicmaterial,suchas sodium caseinate (which contains a milk allergen) or lecithin(which may contain a soy allergen). Staff training could includeallergenidentificationandassessmentofabilitytoclearlysegregateallergens.Themasterlistofallergenicmaterialsshouldalsoconsiderpackaging, processing aids, colors, flavorings and lubricants. Forexample, wheat‐derived or casein‐derived agents in packagingmaterialorlubricantscantransfertofoodproducts.

Considerations for handling and labeling of ingredients containingfoodallergensfollow.

Allergen icons can be useful, especially when different languages are spoken in a facility. You can develop them yourself of consider use of icons available through the International Association for Food Protection: http://www.foodprotection.org/resources/food‐allergen‐icons/

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Consideruseofadocumentedcheckofallergensduringreceivingasaprerequisiteprogram.Thismaybeapreventivecontrolinafacilitythat handles many allergens and produces many products withunique allergens. Identify allergens on rawmaterial labels, use thecommonnameandconsideruseofacolorcodingschemeoricontoreinforcetheneedforcontrolwithinthefacility.Colorcodingmaybeanissueforcolorblindpeople.

Ifbagsorbinsareopenedtotaketestsamplesuponreceipt,donotuse the same knives to open bags of unlike allergens and ensureproper closure after samples are taken. Determine if controls areneededforforkliftdriverstopreventdamagetopackaging.Piercedordroppedbagsandcrackedorbrokenbinspresentallergencross‐contactopportunitiesthatshouldbeavoided.

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Separateallergenandnon‐allergenstorageareas,andusededicatedpallets, combos or bins for allergenic material. If signage is used,considerwhetherthesignisneededinlanguagesotherthanEnglish.Storageoflikeallergenscansimplifymanagement.Forexample,milkandcheese canbe stored togetherbecause theyarebotharedairyproducts.However,walnutsandalmondscannotbestoredtogether,even though they are both tree nuts, because they have differentallergens.

Ifsignageisusedonpallets,maintainuniformplacementareaonthepallet so theallergen label isvisiblewhen thepallet isopenedandboxesareremoved.

Segregationofallergenicfoodsandingredientsduringhandlinghelpsto manage allergen cross‐contact in the manufacturing setting.Preventivecontrolsduringprocessingstart fromthe timeauniqueallergen is introduced into production, and control must extendbeyondthispointaswell.Forexample,powderscaneasilydispersethroughoutanareathroughtheair,thusweighingallergenicpowdersin a different room or area is useful. Covering totes that containallergen‐containingingredientsduringtransferfromoneroomtothenexthelpstopreventunintendedallergencross‐contact.Areviewofventilation systems over lines that handle powders may reveal apotentialallergencross‐contactissue.

Sometimes an allergen may be the primary component of yourproduct and thus does not present an allergen cross‐contact riskbecauseallproductscontaintheingredient.Forexample, inadairyfacility(e.g.,fluidmilk,icecream,yogurt,cheese),milkallergensarepresentinallofthedairyproducts.Segregationbecomesimportantwhenuniqueallergenicingredientsareusedinsomeproductsandnotinothers.Forexample,ifadairyfacilitydecidestoputpeanutclustersin ice cream, the peanut allergen in the cluster could bemanaged

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throughsegregationtopreventintroducingpeanutallergenintootherdairyproductsnot intendedtocontainpeanuts.Likewise, ifadairyfacility decides to pasteurize non‐dairy soymilk on the same line,preventivemeasuresarerequired toensure thatsoyprotein isnotpresentinthedairyproductsandthatdairyproteinisnotpresentinthesoyproduct.

Dependingonthenumberofmajorallergensintheplant,wheretheyareintroducedandtheprocessesused,afacilitymayusesome,allornoneofthesemethodstopreventallergencross‐contact.Determiningwhenpreventivecontrolisrequiredisbasedontheoutcomeofthehazardanalysisprocess.

Rework Management

Properhandlingofreworkandworkinprogressiscritical.Usesturdycontainerswithsecurecovers,andinteriordisposableplasticlinerswhereappropriate.Usededicatedcontainers, lidsandpalletswhenfeasible, or thoroughly wash and sanitize containers before reuse.Usingcontainersthatcanbemovedwithoutuseofequipmenttoholdallergen‐containingmaterials(e.g.,totesonwheels)makesiteasiertosegregatethematerialandreducesthepotentialfordamagebyforklifts.Markthereworkbinproperlywithinformationsuchas:

x Nameofthereworkor Aholdproductx Nameoftheallergenx Date/timeofmanufacturex Date/timeputintostoragex Date/timeforusingrework(ifknown)

Reworkpracticeswithinafacilityshouldbeevaluatedaspartofthehazardanalysisforallergens.Ifreworkisidentifiedasapossibleriskforanundeclaredallergen,considerthefollowingcontrolmeasures:

x Usereworkfor“exactintoexact”applications.

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x Labelthecontainersappropriatelyforstorage.x The amount of allergen‐containing rework generated and

when and where it was used should be documented. Thisdocumentation helps reduce the risk of accidental productmixing.

Personnel Practices

Employees’outerclothingmayaccumulateresidualallergenfromtheprocessing area. This situation should bemanaged. Approaches toconsider include providing dedicated outer clothing (e.g., jacket orsmock) that remains in the entrance to theprocessing areaduringbreaks.Controllingtrafficpatternstoreduceallergencross‐contact,suchaslimitingthetrafficofpeopleandrawmaterialsintoandoutofareasprocessingallergen‐containingproductisofteneffective.Avoidhavingemployeesworkonaprocessinglinethatcontainsallergensandthenmovetoadifferentprocessinglinethatdoesnotcontainthesameallergenprofile.Glovescanalsobeapotentialsourceofallergencross‐contact. Disposable gloves should be discarded immediatelyafterusetoavoidallergencross‐contactissues.

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Allergen Labeling Considerations

ProceduresthatensureaccurateallergenlabelingarerequiredintheFood Safety Planwhen a product contains a food allergen. Supply‐chain programs are also important to ensure that food ingredientsuppliers accurately identify allergens in the products that theyprovide, and packaging suppliers accurately print ingredientinformationonlabels.

Product Labeling

Ensuringthatafoodproducthasthecorrectlabelandpackageisakeycomponentinprotectingthefoodallergicconsumerbecauseitistheonly way for them to know the allergens that are in the product.Undeclaredallergenscanleadtoillnessanddeath.Moreover,labeling

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andpackaging errors are leading causesof allergen‐related recalls,which can cause brand damage, regulatory inquiry, manufacturingdisruption,andpotentialliabilitywhenillnessoccurs.

ou must ensure that all allergens are properly identified on theproductlabel.FALCPA(seeAdditionalReading)providesregulatoryrequirementsthatapplytoensureproperallergenlabelingonFDA‐regulatedproducts.

As discussed in Chapter 5: Chemical, Physical and EconomicallyMotivatedFoodSafetyHazards,labelingerrorsareaprimarycauseofrecalls. Consider controls to check for printer’s errors prior tolabeling.Inmostfacilities,apreventivecontroltoensurethattherightlabelorpackageisappliedtotheproductwillbeanallergencontrol.

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Proofreadinglabelcopyisausefultooltopreventerrors,andsomeorganizations consider this a preventive control. If the label iscomplicated,useacoupleofpeopleduringproofreadingandconsiderdeveloping a written approval process. Using an identity codingsystemforprintedlabelsandpackages(e.g.,colorcodesthatareeasyto visualize) can help with effective label management on theproductionfloor.Proceduresthatdonotallowco‐minglingoflabelson the same pallet during shipping minimize the potential for thewronglabeltobeusedinproduction.

Precautionarylabeling,suchas“MayContain”or“Manufacturedinafacilitythatproduces ”aspecificallergenisnotapreventivecontrol.While unintentional allergen cross‐contact of food products withmajor foodallergens canoccur in themanufacturingprocesswhen

Potential resources for determining labeling options when an ingredient has a precautionary label are:

x FDA’s Guidance for Industry listed in Additional Reading and

x the Food Allergy Research and Resource Program (FARRP) http://farrp.unl.edu/

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productisexposedtotheenvironment,precautionarylabelingcannotbe used to compensate for poor GMPs. When an ingredient has aprecautionarylabel,youmustdeterminehowtohandlethisinregardto your allergen labeling requirements. Chapter 12: Supply‐chainProgramaddressesrequirementsforsupply‐chainprograms,whichincludedocumentationandverificationprocedures.

Ensuring that the correct label is applied toaproduct containingafoodallergen isa requiredallergenpreventivecontrol.Avarietyofapproachesmaybeusedtohelpachievethis.Continuousmonitoring,suchasabarcodescanner,ismosteffective,butmaynotbeaffordablefor some processors. Colored striping on stacked flat labels inpackagingmachinesisanotherapproachtoreduceoperatorerrors.This is particularly useful when the label supply runs out mid‐production.Returningunusedpackagingmaterialstothewarehouse,and not mixing them with other packaging materials helps avoidpackagingmix‐ups.Itisbesttostorepackaging(e.g.,plasticcups,lids)inboxesthataresealedshut.Trainlinepersonneltoensureproductlabelsareswitchedproperlyatproductchangeover.Thisisespeciallyimportantwhenlabelsareappliedtoproduct,suchascans,thatareheldinunlabeledinventoryandlabeledwellafterproduction.

Avarietyofothermeasurescanhelp to reducemistakes, suchasasystemtoassurethatout‐of‐datelabelsandpackagingareremovedand destroyed in a timely manner. Keeping accurate inventoryrecords of labels and packaging can help – if the numbers do notmatch,itislikelythatthewronglabelwasusedonapackagingrun.Stagepackagingsothatonlythoseneededforcurrentproductareinthepackagingarea.Checkpackagingfilmlabelsforaccuracy(e.g.,bycomparingthelabeltotheformulationorrecipeoftheproductbeingproduced)beforetherollisplacedonthepackagingmachine.Foron‐sitecomputergeneratedlabels,verifythatthecorrectelectronicfile

Because applying a label to a package is part of a process, some companies may manage allergen labeling at a process control step and call it a CCP. Other companies may manage it in what they may call an “Allergen Control Plan.” Either approach is fine as long as the allergens that are present in the food are declared on the label.

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isappliedforeachlabel,andhaveasystemthatletsonlyauthorizedpersonneleditelectroniclabelfiles.

Remember that the essential allergen preventive control is thatproduct containers and labels applied during processing aremonitored to ensure that allergen information on labels matchesingredientspecificationsofproduct.

The fictitiousE.G.FoodCompany’s IngredientAllergenAssessment,listsalloftherawmaterialsusedforproducts,alongwiththesuppliername. There is also a column that is used only if precautionarylabeling(e.g.,“MayContain”)labelingisusedbytheirsupplier.ThisinformationhelpsE.G.FoodCompanytoidentifytheallergensthatareintheirproducts,dependingontheingredientsusedineachproduct.

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Using their recipe sheets and the Ingredient Allergen Assessment,theydocumenttheallergenstatementsthatmustappearonlabelsforeachproduct.Asanallergenpreventivecontrol,theycheckthelabeluponreceiptfromthelabelmanufacturertopreventpotentiallabelshortagesincaseamistakewasmadeduringprintingandcheckthelabelnumberwhenlabelsareappliedtoproduct.Checkingthelabelnumberwhenthelabelisappliedinvolveslessdetailedreviewthanreadingthe“contains”statement.Theyincludetheinformationusedattwodifferentstepsononeformavoidpotentialerrorsiftheytriedtomaintaintwodifferentdocumentswiththesameinformation.

Theallergenpreventivecontrolforreviewingthelabeluponreceiptisillustratedaboveandthepreventivecontrolforapplyingthelabeltotheproductisillustratedbelow.Uponreceipt,thelabelcoordinatormatches the information on the label to the product formulainformation. This includes the allergen declaration as well as thelisting of ingredients (we do not provide a complete listing ofingredientsfortheexample).

Label review could be done only at the labeling step, but many organizations perform two label reviews 1) upon receipt and 2) at labeling step. Complex labels require careful review by people trained in technical label wording requirements. Application of the label on line may be simply matching a label number to the product formula.

Training may be appropriate for a label developer, for example if a mistake is made on the copy sent to the printer.

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At theFill,Weigh,Label step, theE.G.FoodCompany’sFoodSafetyPlan states that “All finished product labelsmust have the correctlabel.”Themonitoringportionof theirpreventivecontrols for foodallergens uses the same structure as that for process controls –identifying thewhat, how,when,andwho.At this step, the fill lineoperatormatchesthelabeltotheproductnumber.Correctiveactionaddresseswhattodowiththeproductaswellasidentificationoftherootcauseandtakingappropriateactiontopreventrecurrence.

Aswithprocesscontrols,therecordsassociatedwiththispreventivecontrolprocedureareverified–specificallytheLabelCheckformandanycorrectiveactionorverificationrecords.

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Supply‐chain Preventive Controls Related to Allergens

Whether or not you purchase your ingredients directly from amanufacturer,fromabrokerorfromaretailstore,themanufacturer(orgrower)oftheingredientis“thesupplier”byregulation(seetextbox).Carefullyreviewthelabelforallergeninformationtodetermineif it provides the confidenceneeded forpreventive controls. If not,followupwiththecompanythatmadetheingredienttoobtainmoreinformation. This is especially relevant if “may contain” labeling isusedonyouringredient.

It may be important to understand the level of allergen controlexercised by the manufacturer, depending on the nature of theingredient, the allergen profile of the product and other productsproducedbythesupplier.RefertoChapter12:Supply‐chainProgramforadiscussionofotherrelevantcontrolsatthesupplierlevel.

Definition:

Supplier: The establishment that manufactures/ processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/ processing by another establishment, except for further manufacturing/ processing that consists solely of the addition of labeling or similar activity of a de minimis nature. (21 CFR 117.3)

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Allergen Training

Allergen awareness and control training is critical for the effectiveimplementation of allergen preventive controls. Many foodemployeesdonothavefoodallergiesandneedtobemadeawareofthehealthhazardsposedtoconsumerswithallergiestocertainfoods.Training isuseful foremployeesatall levelsof thecompany. Itnotonly provides an opportunity to build knowledge, but alsocommunicates the importance of each employee’s role in allergenmanagement.Overall,trainingreinforcesacommitmenttofoodsafetyandhighlightschangesorimprovementsinproduction.

Supervisorypersonnelmustbetrainedinthekeysareasofallergenpreventive controls so that they have the knowledge to trainproduction workers. Food production workers must be trained ineachoftheareasrelevanttotheirjobresponsibilities.Foodallergentrainingatregularintervalsreinforcesproperpracticesandremindsworkersoftheirimportancetofoodallergicconsumers.

The section on allergens in Chapter 5: Chemical, Physical andEconomicallyMotivatedFoodSafetyHazardsisagoodstartingpointfor allergen awareness training. Sanitation chemical providersfrequentlyhavetrainingmaterialsonallergensaswell.Itisimportantto know your culture and the type of training that works at yourlocation.Budgetconstraintsmaylimittheoptions,butgoodexternaltraining is available through recognized resources (see AdditionalReading).

The University of Nebraska’s Food Allergy Research and Resource Program (FARRP) provides resources and training relevant for food manufacturers. http://farrp.unl.edu/workshopsandtraining

Other programs may also be available in your area.

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Food Allergen Preventive Controls Summary

Food allergens present a risk to consumer health and are amajorcauseoffoodsafetyrecalls.Becauseofthis,foodallergenpreventivecontrols are required to prevent allergen cross‐contact with foodallergenicmaterialandensurethatproductsareaccuratelylabeled.Avariety of methods exist to reduce the potential for undeclaredallergenstobepresentinfoodproducts.Theseincludeyoursupply‐chain program, ingredient handling, allergen cross‐contactprevention, accurate labeling and employee training. Additionaltraining and information on food allergens is available throughsources listed below and in Chapter 7: Resources for Food SafetyPlans.

Additional Reading FDA:GuidanceforIndustry: uestionsandAnswersRegardingFoodAllergens,

includingtheFoodAllergenLabelingandConsumerProtectionActof2004(Edition4);FinalGuidance

FoodAllergyResearchandResourceProgram(FARRP)andFoodAllergyandAnaphylaxisNetwork.ComponentsofanEffectiveAllergenControlPlan–aFrameworkforFoodProcessors

Gendel,S.M.andJ. hu.2014.2013.AnalysisofU.S.FoodandDrugAdministrationfoodallergenrecallsafterimplementationoftheFoodAllergenLabelingandConsumerProtectionAct.J.FoodProt.76(11)1 33‐1 38.

Gendel,S.M.,J. hu.N.Nolan,K.Gombas.2014.LearningfromFDAfoodallergenrecallsandreportablefoods.FoodSafetyMagazine.April‐May2014:46‐52,80

GroceryManufacturersAssociation(GMA).200 .ManagingAllergensinFoodProcessingEstablishments

Jacksonetal.2008.Cleaningandothercontrolandvalidationstrategiestopreventallergencross‐contactinfood‐processingoperations.JFoodProt.71(2):445‐458.

Pieretti,M.M.,Chung,D.,Pacenza,R.,Slotkin,T.,Sicherer,S.H.200 .Auditofmanufacturedproducts:Useofallergenadvisorylabelsandidentificationoflabelingambiguities.JAllergyClinImmunol.1242):337‐41

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CHAPTER 11. Sanitation Preventive Controls

Sanitation is the beginning, not the end, of food processing. It establishes the basic hygienic conditions needed to produce safe and wholesome food. Without a clean operation to start, equipment and the environment can introduce potentially hazardous contamination. It can also contribute to loss of quality. Sanitation practices are required by Good Manufacturing Practices (GMP), including general cleaning, and washing and sanitizing of equipment, walls and floors (see Appendix 5: Sanitation Basics). Facilities must meet all applicable GMP requirements but documentation is required only for hazards requiring preventive controls. This chapter covers sanitation preventive controls identified through hazard analysis.

The Preventive Controls for Human Food regulation requires implementation of sanitation preventive controls, as appropriate to the facility and the food, to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handing, and food allergen hazards. The hazard analysis identifies hazards requiring a preventive control.

This chapter begins with a review of sanitation-related food safety hazards and hazard analysis examples. Then preventive controls to assure cleanliness of food-contact surfaces, and prevention of allergen cross-contact and biological cross-contamination from objects and personnel in certain facilities are discussed. Finally, monitoring, corrections and verification requirements for sanitation preventive controls are addressed.

Sanitation Preventive Controls Objectives

In this module, you will learn:• Major food safety hazards

controlled by sanitation practices

• That sanitation preventive controls are identified through hazard analysis

• Sanitation preventive controls management components required in a Food Safety Plan� Monitoring� Corrections� Verification

ProcessFood A

llergenSanitation

PREVENTIVE CONTROLS

Requirements based on Hazard

Analysis Supplier /Other

Definitions:

Allergen cross-contact: The unintentional incorporation of a food allergen into a food. (21 CFR 117.3)

Cross-contamination: The unintentional transfer of a foodborne pathogen from a food (where it may occur naturally) or insanitary object to another food (where it may present a hazard).

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Food Safety Hazards Controlled by Sanitation Preventive Controls

Environmental pathogens such as Salmonella and Listeriamonocytogenesaremajorfoodsafetyhazardsformanyready‐to‐eatproducts that are exposed to the processing environment prior topackaging.SanitaryfacilitiesareessentialtosignificantlyminimizeorpreventthesehazardsfromcontaminatingRTEfood.

Cross‐contaminationmustbecontrolledtopreventpathogensfromgettingintothefood.AsdiscussedinChapter4:BiologicalFoodSafetyHazards,foodbornepathogenscanenterafacilityonrawmaterials.Cleanequipmentandemployeepracticesthatminimizethetransferof these pathogens from raw ingredients to ready‐to‐eat productsmaybeessentialtoeffectivelycontrolthesehazards.

Employee practices are also important to prevent allergen cross‐contactbetweenproductsthatcontainfoodallergensandthosethatdonot.AsdiscussedinChapter10:FoodAllergenPreventiveControls,food allergens can also be transferred from equipment that is notcleanedtoremovethembeforenon‐allergencontainingproductsarehandled.

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GMPsandotherprerequisiteprogramsworktogethertoestablishasoundfoundationforyourfoodsafetysystem.Theconsiderationsonthe slide above are usually managed as GMPs. Employee hygiene,personnelpracticesandthedesignofthefacilitymustpreventcross‐contamination and allergen cross‐contact. It is important foremployeestounderstandthattheiractionscancontributetoproductcontamination. Employees’ hands or gloves, and equipment andutensilsmustbewashedandsanitized,whennecessaryafterbeingcontaminated.Forexample,employeesworkinginarawproductareashouldnotworkwithacookedfinishedproductwithoutwashingandsanitizingtheirhands,gloves,equipmentorutensilstoavoidcross‐contamination. Similarly, employees handing food allergens shouldwash theirhandsbeforehandling food thatdoesnot contain thoseallergenstopreventallergencross‐contact.

Personal cleanliness is also important to prevent productcontamination and is generally managed through GMPs. Workersmustwearcleanandappropriateattire,andmustwashandsanitizetheirhandsatappropriateintervals.Whenglovesareused,theyarenotasubstituteforhandwashing–leakage,cross‐contaminationandallergencross‐contactcanoccur.

Plant design must prevent potential contamination of storedingredients and raw materials, food, and food contact surfaces,includingseparationofoperationswherecontamination is likely tooccur.Thismeansseparatingrawproductandunpackagedready‐to‐eatproducttoavoidcontamination.Similarly,separatingfoodsthatcontainfoodallergensfromthosethatdonotcontainthesamefoodallergenshelpstoavoidallergencross‐contact.Foodcontactsurfacesmustbecleanedandsanitized,asappropriate,whencontaminated.Packagingmaterialsmustbestoredandhandledproperlysotheydonotbecomeasourceofcontamination.

GMPs related to cleaning and sanitation are addressed in 117.35(d), (e), and (f). These can be managed as prerequisite programs unless the hazard analysis identifies hazards requiring a preventive control to address allergen cross‐contact or cross‐contamination.

For more information on basic cleaning and sanitation, see Appendix 5: Sanitation Basics.

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Hazard Analysis Example

The hazard analysis process determines the hazards requiring apreventive control. Identifying specific hazards and preventivecontrol procedures is required, and the procedures must beperformedasdesignedonacontinuedbasis toprevent thehazard.TheE.G.FoodCompany’shazardanalysis foromelets identifiedtheAssemble,Wrapstepasastepwhereasanitationpreventivecontrolwasnecessary toprevent introductionofenvironmentalpathogenssuchasL.monocytogenes.Atthissteptheproducthasbeencookedandthenhandledsocross‐contaminationcouldoccur.Nootherstepintheprocesswouldeliminateenvironmentalpathogensthatmightbeintroducedthroughhandlingafterthecookstep.

Thepotentialforallergencross‐contactfromthewheatinthebiscuitto non‐biscuit containing products was also identified as a hazardrequiringapreventivecontrolatthisstep.Thepotentialforallergencross‐contact can be significantlyminimized or prevented throughsanitation.ThustheslideabovedocumentsthesanitationpreventivecontrolsthatarerequiredtobeaddressedintheE.G.FoodCompany’sFood Safety Plan. Other sanitation practices are handled throughroutineGMPproceduresattheE.G.FoodCompany’splant.TherestofthischapterfocusesonsanitationpreventivecontrolsrequirementsandnotGMPs.

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Lack of effective sanitation preventive controls has contributed tomajor recalls.Whenhazardanalysis identifies ahazard requiringasanitation preventive control, the procedures, practices andprocesses used to manage these hazards must be developed anddocumented. As appropriate to the food, facility and how thepreventive control fits in the food safety system, this may involveprocedures to ensure the cleanliness of food‐contact surfaces,includingfood‐contactsurfacesofutensilsandequipment.Itmayalsoinvolve procedures to significantly minimize or prevent allergencross‐contactandmicrobialcross‐contamination.

Preventing hazard transfer from insanitary objects (such as dirtyequipmentandenvironmentalsources)andfrompersonneltofood,tofoodpackagingmaterial,andtootherfoodcontactsurfacesmaybeappropriate depending on the operation. Preventing transfer fromraw or unprocessed product to processed product may also beappropriate in some situations (e.g., from uncooked to cookedproduct,fromunwashedtowashedproduct,etc.).

Personnelcanplayabigroleinpreventingtransferofcontamination.FoodsafetytrainingisrequiredbythePreventiveControlsforHumanFood regulations. This can help your employees to understand theimportant role theyplay in the foodsafetyprogram.TheE.G.FoodCompany example includes color‐coded smocks for employeesworkingintheAssemble,Wrapareaasanexampleofapracticethancanminimizetransferofenvironmentalpathogensintothissensitivearea IFemployeesunderstandwhytheyarerequiredto followthisprocedure.

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Cleanlinessoffood‐contactsurfacesisaprimaryfocusforsanitationpreventive controls. However, prevention of allergen cross‐contactand microbial cross‐contamination requires consideration ofsanitation practices for both food‐contact and non‐food contactsurfaces because of environmental pathogens. For example, whenmanufacturing low‐moisture foods such as chocolate andconfectionaryproducts,drycleaningproceduresfacilitatecontrolofenvironmental pathogens such as Salmonella. However, control ofallergensmaybeeasierwhenwet cleaningprocedures areused.Afacilitymustcarefullyconsiderwhentousewetcleaningversusdrycleaning.

Food‐contactsurfacesused for low‐moisture foodmustbe inclean,dry and sanitary condition before use.When the surfaces arewet‐cleaned, they must, when necessary, be sanitized and thoroughlydried before subsequent use. Moisture retained in environmentalcracks and crevices can support pathogen growth, so use of wet‐cleaningindryenvironmentsshouldbeavoidedwhenpossibleandshouldnotbearoutinepractice.SeeAppendix5:SanitationBasicsformoreinformationonwetversusdrycleaning.

Use of hygienic zoning to minimize transfer of hazards andconsiderations to minimize hazard transfer through personalpracticesmayalsobeimportant,dependingupontheprocessandtheproduct.Thisisdiscussedbelow.

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Hygienic Zoning

Sanitationisnottheonlycontrolusefulinpreventingcontaminationoffoods.Theconceptofhygieniczoningwasdevelopedforfacilitieswhererawandready‐to‐eatproductsarehandled;however,similarconceptscanbeappliedforallergencontrolandfordryversuswetcleaningareas.Every facilityhasdifferentneeds,dependingon theproduct,thestructure,trafficpatternsandotherfactorsinvolvedwithprocessing andhandling food. Identifying areas that are specific tocontrolofhazardsrequiringapreventivecontrolandsanitationneedscanreduceclean‐uptimeifdesignedandimplementedwell.

The slide above discusses different types of hygiene areas. Non‐manufacturingareasdonot require the same level of sanitation asfood processing areas. Transition areas into a GMP or processingspaceshouldbeequippedwithmaterialstominimizethepotentialfortransferring potential pathogens into the facility. For example,smocks,footwear(ifneeded),haircoversetc.aretypicallyavailableintransitionareas,aswellashand‐washingstations.SanitationneedsinbasicGMPareas(suchasreceivingandstorageareasandthosethathandle raw product) that are physically separated from sensitiveareas (e.g., where an RTE food is exposed to the environment)typically are managed by GMP requirements and not preventivecontrol requirements. More attention to sanitation and primarypathogencontrolisneededinareasthathandleready‐to‐eatproductsthatareexposedtotheenvironment.Evenmorediligenteffortsareneededinareasthathandleproductsforsensitivepopulationssuchasinfants.

Controloftrafficpatternsbetweentheseareaswithdifferentlevelsofhygienecanminimizethetransferofhazards.Techniquesthatmaybeusefulinclude:

See Appendix 6: Hygienic Zoning and Environmental Monitoring for more information on this topic.

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x Dedicatedequipmentindifferentareas,especiallywhenitisdifficulttoclean(e.g.,carts,forklifts)

x Useofcolor‐codeduniformsforpeoplewhoworkontherawsideandthosewhoworkonthecooked/ready‐to‐eat(RTE)side

x Linearflowthroughafacility,suchthatrawproductdoesnotenterthecooked/RTEproductarea.

Itisunderstoodthattheabovemaynotbepracticalinallsituations.However, there is a requirement that efforts are made to preventallergen cross‐contact and cross‐contamination when hazardsrequiringapreventivecontrolareidentifiedthroughhazardanalysis.Preventivecontrolscanaddressthisthroughzoningandothermeans,asdictatedbythesituationatthefacility.

Each facilitymustdeterminetheneed forandscopeofasanitationpreventive control program based on the potential for productcontamination.Theassessmentshouldtakeintoaccountthephysicalstructureitself;personnel,packagingandingredienttrafficflows;andanycross‐overareas.Itshouldalsoconsiderpotentialcontaminantsfromrawmaterials,airflow,supportareasandactivitiestakingplacein the facility, which may include potential allergen andmicrobiological concerns. The sanitation preventive controls mustaddresstargetedenvironmentalpathogensifrelevanttotheproductbeingproduced.A facilitymaychoosetousezoningforallergens ifthisisdeterminedtobeaconcernthroughhazardanalysis.

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Themapaboveis fromthehygieniczoningexampleinAppendix3:FoodSafetyPlanExample.TheAssemble,WrapAreaisdesignatedasaprimarypathogencontrolareawithcontrolledaccessbecausethecookedomeletsareexposedtotheenvironmentpriortopackaging.

Documenting Sanitation Preventive Controls

If the hazard analysis identifies a hazard requiring a sanitationpreventive control,writtenproceduresmustbedocumented in theFood Safety Plan. This may include procedures, practices andprocessesneededtoensurethecleanlinessofparticularfood‐contactsurfaces, including utensils and equipment. They alsomay includeprocedurestopreventcross‐contaminationorallergencross‐contactfrom insanitary objects, as well as from personnel to food, foodpackagingmaterial and other food‐contact surfaces. Procedures to

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preventcross‐contaminationfromrawproducttoprocessedproductare also included in the Food Safety Plan, when appropriate asidentifiedinthehazardanalysis.

The most effective cleaning and sanitizing procedures contain thefollowingelements:

x thepurposeofdoingtheproceduretoensurethattheoperatorunderstandswhyasanitationpreventivecontrolprocedure issoimportant

x thefrequencyorwhentheprocedureneedstobeconductedtobeeffective

x who is responsible for performing the procedure and othertaskslisted

x the procedural instructions to accomplish the task, includingidentificationoftools,chemicals,andspecificsteps,sometimesincluding pictures, especially if disassembly of equipment isrequired

x monitoring to provide a record that that the procedure wasperformed

x corrections,orwhattodowheninspectiondeterminesthattheprocedurewasnot adequate toproducea sanitary surfaceorarea

x verificationproceduresx thenameoftheformusedtorecordmonitoringactivities

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AnexampleofthesanitationprocedurefortheE.G.FoodCompany’sassembly table appears above. This is only an example of how asanitationpreventivecontrolcouldbedocumented.Theformatusedcan vary considerably, and may even use photographs instead ofwords.

Sanitation Monitoring

Sanitation preventive controls must be monitored and resultsrecorded as appropriates. The term monitor is defined in thePreventive Controls for Human Food regulation as “to conduct a

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planned sequence of observations or measurements to assesswhether controls are operating as intended.” As discussed above,procedures related to the sanitation process, as well as hygieniczoning,ifusedasapreventivecontrol,requiremonitoringrecords.Anexample of the type of record that could be used for cleaning andsanitizingisillustratedbelow.

AnE.G.FoodCompanyexampleofaDailySanitationControlRecordforitsomeletlineisillustratedabove.Itincludesseveralmonitoringactivitiesonthesameform.Visualobservationofcleanlinessisonetypeofmonitoringactivity,recordedassatisfactoryorunsatisfactoryon the initial observation. Recording the sanitizer concentration isanother monitoring activity, which documents the specificconcentrationofthesanitizerused.Teststripsarefrequentlyusedforthis typeof activity.Makesure thata test stripappropriate for thespecificsanitizerisused.

It is entirely likely that a facilitymaywant touse severaldifferentformstorecordtheinformationinordertolocatetheformwherethecleaningtakesplace.Forexample,therecouldbeamonitoringrecordlocated in the equipment cleaning room to record the sanitizerconcentration ina tankused tosubmergecleanedequipmentparts(e.g., gaskets, cutter blades etc.). Other sanitation forms may belocatedintheproductionareanexttotheequipmentbeingcleaned.

The facilitymustdeterminehow frequentlycleaningandsanitizingoccurs, an important consideration to minimize the potential forenvironmental pathogens to become established and to preventgrowth of pathogens on food residues remaining on surfaces. Achemicalsuppliercanhelpprovideguidelinesforcleaningfrequency

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inmanysituations.NotethatnotallsanitationproceduresneedtobeincludedinaFoodSafetyPlan.Sanitationproceduresconductedforquality reasons fall under GMPs rather than sanitation preventivecontrols and, thus, are not required to be documented in the FoodSafetyPlan.

The date, time (when appropriate), and intials of the operatorperforming themonitoring taskmust be included on amonitoringrecordeachtimetheyperformthetask.

Corrections

Whendeficienciesatasanitationpreventivecontrolareencountered,corrections must be made in a timely manner. The nature of thecorrectionsdependsonthespecificsituation.Sometimescorrectionsarerelativelyeasy.Forexample,iffoodresidueisobservedon“clean”equipment, the equipment should be re‐cleaned. If the sanitizerconcentrationisdeterminedtobeincorrect,anewsanitizersolutionshouldbepreparedandtheequipmentshouldbere‐sanitized.Notethat re‐sanitizing equipment can be avoided if the sanitizerconcentrationischeckedbeforeitisused Thepersonnelcleaningtheequipmentmayneedtobere‐trained.

Corrections versus Corrective Actions

Actions to correct conditions or practices related to cleanliness and prevention of cross‐contamination and allergen cross‐contact must be taken in a timely manner. When timely action is taken, “corrections” such as those described in the cleaning procedure, are adequate and, when appropriate, must be documented.

If action is not taken in a timely manner (e.g., unsanitary conditions exist for an extended period), full corrective action as described in 21 CFR 117.150 is required (e.g., product on hold, evaluate risk, etc.).

Definition Correction – An action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce).

‐ 21 CFR 117.3 Definitions

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TheexampleabovefromtheE.G.FoodCompanyexample,illustrateshow corrections can be described in a cleaning procedure. OthercorrectionandcorrectiveactionprocedureexamplesareinAppendix3forothersanitationpreventivecontrolprocedures.Thiscorrectionprocedure informs operators the action that must be taken ifproceduresarenotproperlyfollowed.Becausethesearecorrectionprocedures(andnotcorrectiveactionprocedures),completionofacorrectiveactionreportisnotrequired.

Sanitation Verification

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Verification is conducted to confirm that the sanitation preventivecontrols are properly implemented and the system is operating asintended. Review of sanitation preventive control records is also arequired verification activity. Verification activities must bedocumented.

Thespecificverificationactivitiesdependonthefacilityandhowthesanitationactivitiesaresetup.Forexample,somefacilitiespreparesanitizing solutions every day. Other facilities use an automateddosing system that includes a monitoring device. In the former,checking the sanitizer concentration right after you make it is amonitoring activity. However, if you periodically check theconcentrationofanautomatedsystem,thisisaverificationactivity.Ineithercase, thiscanbeaccomplishedthroughteststrip, titrationorother methods frequently provided by the chemical supplier. Theimportant thing is that the chemical concentration is checked anddocumented

Some facilities may use quantitative microbiological swabs (e.g.,swabbing a 3 u 3 inch (10 u 10 cm) area and plating) or indirectmethodslikeATPmonitoringtoprovidequantitativeverificationoftheeffectivenessofsanitationprocedures.

Environmental monitoring for an environmental pathogen or anappropriate indicatororganismisrequiredwhenanenvironmentalpathogenisahazardrequiringapreventivecontrol.Thismaybethecase in facilities where ready‐to‐eat product is exposed to theenvironmentbeforepackaging.

An effective environmental monitoring program diligently tries tofindthepathogenorindicatorofconcernsothatcorrectionscanbemadebeforeproductiscompromised.Environmentalmonitoringisaverification procedure for such a facility. Corrective actions

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procedures (instead of corrections) must document actions to betakenwhentheenvironmentalpathogenoranindicatororganismisdetected.SeeChapter13:VerificationandValidationProceduresandAppendix 6: Hygienic oning and Environmental MonitoringSupplementalInformationifitappliestoyourfacility.

Sanitation Preventive Controls Summary

SanitationisanelementofGMPsthatisrequiredinallfacilities.Forsome products and processes, the hazard analysis will identifyspecificinstanceswheresanitationpreventivecontrolsareessentialtoprotectconsumersfromcontaminatedproduct.Hazardsrequiringsanitationpreventivecontrolsdependonthefacilityandmayincludeenvironmental pathogens when RTE food is exposed to theenvironment, pathogens transferred through cross‐contaminationandallergenstransferredthroughallergencross‐contact.Sanitationpreventivecontrolsfocusonthecleanlinessoffood‐contactsurfaces,and prevention of cross‐contamination and allergen cross‐contact.When identified in the hazard analysis process, these sanitationpreventivecontrolproceduresmustcomplywithpreventivecontrolsrequirementsandbedocumentedintheFoodSafetyPlan.Requiredinformationincludesmonitoringactivitiesandfrequency;correctionsfor most procedures; corrective actions for allergens andenvironmentalpathogens,ifrelevant;andverificationactivities.

Additional Reading The FSPCA Website has many useful references on sanitationpractices.Inaddition:

x SeeAppendix5:SanitationBasicsandtheFSPCAwebsiteforawealth of references, including sanitary design checklists,basicsanitationandGMPtrainingprograms

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x See Appendix 6: Hygienic oning and EnvironmentalMonitoringformoredetailandreferencesonthesetopics.

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CHAPTER 12. Supply‐chain Preventive Controls

Thesafetyofyourproductdependsonmuchmorethanjustwhatyoucontrolwithinyourownfacility.Useofaningredientthathasahistoryof association with a specific hazard may require a supply‐chainprogramas apreventive control. In this course, the terms “supply‐chain preventive control” and “supply‐chain program” refer torequirementsinSubpartG–Supply‐chainPrograminthePreventiveControlsforHumanFoodregulation.Companiesmayhaveextensivesupplier programs that encompass much more than food safetyelements to manage their supplier expectations and performance.This chapter focuses on the requirements of the regulation forverifyingmeasuresforcontrolofhazardspriortoreceiptandnotacompany’sothersupplierefforts.

Understanding the potential hazards associated with your supplychainhelpstodeterminepreventivecontrolsneededtocontrolthosehazards,eitherwithinyourfacilityoratthesupplier.SomepotentialhazardshaveminimalfoodsafetysignificanceandcanbeaddressedbyGMPprograms.Chapters4and5onFoodSafetyHazardsidentifysome ingredients that have a history of association with specificfoodborne hazards. This chapter reviews definitions of supplier,receivingfacilityandcustomerastheyapplytothePreventiveControlsfor Human Food regulation. Required contents for a regulatorycompliantsupply‐chainprogramarediscussed,aswellasappropriateactivitiestoverifycontrolatthesupplierlevel.Recordrequirementsarealsodiscussed.

NOTE:

For simplicity, the term ingredients may be used in place of the phrase “raw materials and other ingredients” used in the regulation.

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Special requirements for Foreign Supplier Verification Programs(FSVP)forImportersofFoodforHumansandAnimalsarenotcoveredinthischapter.However,ifyouimportfoodproductsoringredientsyou also need to comply with some additional requirements.RegardlessofwhetheryouringredientscomefromaU.S.oraforeignsupplier,theprincipleswithrespecttofoodsafetyarethesame.

Link to Hazard Analysis

The hazard analysis process (See Chapter 8: Hazard Analysis)determineswhenahazardrequiringasupply‐chain‐appliedcontrolexists.Someingredientsmaynothavehazardsrequiringapreventivecontrol. For example, an ingredient like vinegar has not beenassociated with significant food safety issues. A vinegar processormust operate under GMPs, conduct their own hazard analysis andimplementcontrolsasnecessary,buttypicallyareceiverofvinegarmay safely conclude that a food safety hazard requiring a supply‐chain‐appliedcontrolisnotlikelytobeaconcern.

Otheringredients,however,dohaveanassociationwithspecificfoodsafety hazards. ou do not need a supply‐chain program if youimplement apreventive control for thehazardwithin your facility.However, if you are a manufacturer/processor and the hazard iscontrolledbeforeyoureceivetheingredient,asupply‐chainprogramisrequired.Toillustratethispoint,letuslookatdifferentoptionsthatcouldhavebeenusedbytheE.G.FoodCompanytoaddressthehazardofSalmonellaineggs.

If applicable to your operation, see the Foreign Supplier Verification Program requirements on FDA’s website. See the FSPCA website for information on the FSPCA Foreign Supplier Verification training program.

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ThehazardanalysisfortheE.G.FoodCompanyidentifiedSalmonellaasahazardrequiringapreventivecontrol inthe liquidpasteurizedeggsthattheyreceive.Theychosetouseaprocesspreventivecontroltopreventthehazardfromcausingillnessbytheconsumingpublic.However,theycouldhaveusedotherpreventivecontrolsapproaches:

x E.G.FoodCompanycouldhaveusedasupply‐chainprograminsteadofprocesscontrol.Thiswouldrequirethattheyverifythatthecontrolsatthesupplier(forpasteurizationoftheeggandforpreventingrecontamination)areadequatetocontrolthehazardonanongoingbasis.

x Alternatively, the E.G. Food Company could have avoidedapplying apreventive control by informing their customersthattheomeletsare“notprocessedtocontrolSalmonella”andby obtainingwritten assurance from all of their customersthattheyheatallomeletsservedtoavalidatedtemperaturethatwouldkillSalmonella.

In any of the three approaches the hazard (Salmonella) can beeffectivelyinactivatedtopreventillness.TheE.G.FoodCompanycanchoose to apply any one of these approaches to ensure the hazardfromSalmonellaiscontrolled.TheE.G.FoodCompanydecidedtouseprocesscontrolforthehazardofSalmonellainpasteurizedliquidegg,perhapsbecausetheythoughtitwasmoreefficienttomonitortheirown process. Additionally, cooking the omelet will also addresspotentialrecontaminationof theomeletbatterduringmixing.Theyhandled pasteurized milk in a similar manner – using a processpreventivecontrol.

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Conversely,E.G.FoodCompanyidentifiedasupply‐chaincontrolforthebiologicalhazardsinpasteurizedprocesscheese.Inthisexample,the hazard analysis concluded that pasteurized process cheese hasvegetative and sporeforming pathogen hazards requiring a supply‐chain‐appliedcontrol.TheE.G.FoodCompanydidnothaveprocessesinplacetocontrolthesehazardsbecausethecheesewasjustplacedonthecookedomeletwithoutanyadditionalheat.Theyapprovethesupplier and use a third party audit to verify that controls areadequate. Other verification options are discussed later in thischapter.

Theexamplesonthisandthepreviousslideillustratetheflexibilitythatacompanycanusetoensurethathazardsrequiringapreventivecontrol are controlled. Sometimes there are options, suchas in thepasteurized egg example for the omelets. However, sometimessupply‐chain control is the only option, such as in the pasteurizedprocesscheeseexample.

While the 3rd party audit is not conducted at receiving, the shipping clerk checks to assure that the material came from the approved supplier. Because the audit is not conducted at receiving then others may choose to check no.

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Who Must Establish a Supply‐chain Program

Tounderstandsupply‐chainprogramrequirements,itisimportanttounderstandthedefinitionofsupplier,receivingfacility,andcustomerinthecontextoftheregulation.Reviewthedefinitionsinthetextboxandtheillustrationabove.

ou(themanufacturer/processor)arethe“receivingfacility”fortheraw material or other ingredient. our “supplier” may be amanufacturerorprocessorofthefoodthatyoureceive.Notethatifyoureceiverawagriculturalingredients,your“supplier”istheentitythatgrowsthefoodorraisestheanimal.Forexample,ifFarmerGreengrowsacropthatisharvestedandlabeledbyaregionalharvestingorganization,yoursupplierisstillFarmerGreen.

our“customer”canbeanothermanufacturer/processororanentitythatpreparesthefood,suchasafoodserviceorretailestablishment,orother.ThecustomermayormaynotbesubjecttothePreventiveControlsforHumanFoodregulation.

As the receiver,youmustdocumentand implementa supply‐chainprogramwhenhazardsrequiringasupply‐chain‐appliedcontrolareidentifiedthroughhazardanalysis.

Definitions

Supplier: The establishment that manufacturers/ processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/ processing by another establishment, except for further manufacturing/ processing that consists solely of the addition of labeling or similar activity of a de minimis nature. ‐ 21 CFR 117.3

Receiving facility: A facility that is subject to subparts C [Preventive Controls] and G [Supply‐chain Program] of this part and that manufactures/ processes a raw material or other ingredient that it receives from a supplier. ‐ 21 CFR 117.3

Customer: The entity the receiving facility sells to. May or may not be subject to the requirements for hazard analysis and risk‐based preventive controls and may manufacture, process, or prepare the food in accordance with applicable food safety requirements. ‐Based on 21 CFR 117.136

Supply‐chain‐applied control: A preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. ‐ 21 CFR 117.3

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Asupply‐chainprogramisnotrequiredinthefollowingsituations:

1. Thehazardanalysisconcludesthattherearenohazardsrequiringasupply‐chain‐appliedcontrol,

2. ou control the hazards requiring a preventive control withinyourfacility,or

3. ourelyonyourcustomertocontrolthehazard,youidentifyforyourcustomerthatthefoodhasnotbeenprocessedtocontrolthehazard, and you have annual written assurance from yourcustomerthattheyarefollowingprocedurestodoso.

Forexample,CompanyA’shazardanalysisdeterminesSalmonellaisahazardinrawnutsthattheyreceiverawfromafarmer(thesupplier).CompanyA sorts and shells the nuts for their customer,who thenroaststhenutsusingavalidatedprocess.CompanyAisnotrequiredto apply a preventive control for Salmonella if 1) they disclose indocuments accompanying the shipment that the nuts were notprocessedtocontrolSalmonellaand2)theyobtainwrittenassurancefrom their customer, on an annual basis, that Salmonella is beingcontrolled along with information on how it is being controlled.Documentationrequirementsvarydependingonwhetherornotthecustomer is subject to the Preventive Controls for Human Foodregulation.Consult21CFR117.136forspecificrequirementsifthissituationappliestoyou.

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Two additional situations where the supply‐chain programrequirements do not apply are 1)when the receiving facility is animporter in compliance with the foreign supplier verificationrequirements(FSVP)and2)whenthefoodissuppliedforresearchorevaluationuse.Areceivingfacilitythatisanimporterincompliancewith FSVP requirements already has documentation that providesassurancethatthehazardsrequiringasupply‐chain‐appliedcontrolhavebeensignificantlyminimizedorprevented.

Foodthatissuppliedforresearchorevaluationuseisnotsubjecttosupply‐chainprogramrequirementsprovidedthat:

x the food is not intended for retail sale and is not sold ordistributedtothepublic;

x thefoodislabeled“Foodforresearchorevaluationuse;”x the food is supplied in a small quantity consistent with a

research,analysisorqualityassurancepurpose,itisusedonlyforthatpurposeandunusedfoodisproperlydisposedof;and

x thefoodisaccompaniedwithdocumentsstatingthatitwillbeused for research or evaluation and cannot be sold ordistributedtothepublic.

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General Requirements

Generalrequirementsforyoursupply‐chainprogramwhenasupply‐chain‐appliedcontrolisidentifiedarelistedabove. oumustapprovesuppliersfortheseingredientsforwhichasupplierhasappliedthecontrol for a hazard. oumust determine the supplier verificationactivities that you will use to verify that the supplier is applyingappropriatecontrols,andthenyoumustensurethattheseactivitiesareconductedanddocumented.Theseactivitieswillvary,dependingon the food, thehazardandyour foodsafety system.Eachof theserequirementsisdiscussedbelow.

In some situations, the supply‐chain‐applied control may beconducted by an entity other than your supplier. For example,aflatoxin is a hazard associatedwith field corn. Amilling companymayhaveanaflatoxincontrolprogramforthedriedcorntheyreceive.Abakingmixcompanymayconductverificationactivitiesatthemillertoensurethataflatoxiniscontrolled.Ifyoureceivecornbreadmuffinmix,youmayverifythedocumentationfromthebakingmixcompanyontheirprogramforthemiller.

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Using Approved Suppliers

oumustapprovesuppliersofingredientsrequiringasupply‐chain‐appliedcontrolbeforeyoureceivethematerial.Whennecessaryandappropriate, unapproved suppliers whose material is subjected toadequateverificationactivitiesbeforeuse(seeverificationdiscussionbelow)maybeusedonatemporarybasis.

our supplier approval programmusthavewrittenprocedures forreceiving the ingredients requiring supply‐chain‐applied controls.Additionally,recordsthatdocumentthatmaterialisindeedreceivedfrom approved suppliers are required. ou may use your existingreceivingrecordsystemoraddtoittorecordthisinformation.

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Determine Supplier Verification Activities

Once approved suppliers are identified, you must identify andimplement appropriate verification activities to ensure that thesupplieractuallycontrolsthehazardrequiringasupply‐chain‐appliedcontrol.Verificationisusuallynotconductedatthesamefrequencyasmonitoring activities (see Chapter 13: Verification and ValidationProcedures). Typically, verification is conducted after the fact as acheckthatthesystemisoperatingaccordingtotheplan.Whilesomeverificationactivitiesareperformedforeachlot(e.g.,recordsreviewforin‐housepreventivecontrols),somesupplierverificationactivitiescould be performed at a reduced frequency, depending on manyfactors,includingthenatureofthehazardandsupplierperformance.

Appropriate supplier verification activities are listed on the slideabove. One ormore of the following verification activitiesmust beconducted before initial use and periodically thereafter foringredientsthatrequireasupply‐chain‐appliedcontrol.

x Anannualonsiteauditoffoodsafetypracticesconductedbyaqualifiedauditor.Thisisrequiredforhazardsthatcancauseserious adverse health consequences or death unless youdevelopwrittenjustificationforwhylessfrequentauditingoranotherverificationactivityprovidesadequateassurancethatthehazardisbeingcontrolled.

x Samplingandtestingofthesupplier’sproductforthehazardofconcern.Thismaybedonebythesupplierorthereceivingfacility.

x Areviewofthesupplier’srelevantfoodsafetyrecords,suchasprocessingtimesandtemperatures.

x Other procedures based on the risk associated with theingredientandthesupplier.

Definition

Verification: Those activities, other than monitoring, that establish the validity of the Food Safety Plan and that the system is operating according to the plan.


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Theextenttowhichanyoftheseactivitiesisusedmustberisk‐basedandconsistentwithregulatoryrequirements.

Theverificationactivitiesuseddependonthespecificsituation.ThePreventiveControlsforHumanFoodregulationrequiresconsiderationof the above in determining relevant verification activities. Forexample,whenconsideringthehazard,isitlikelytobepresentathighconcentrations that would easily be detected by testing, or is theconcentration expected to be so low that testing is unlikely to bereliableindetectingthehazard ThisconceptisdiscussedfurtherinChapter13:VerificationandValidationProcedures.

Whereapreventivecontrolisapplied(e.g.,atthesupplieroratthesupplier’s supplier) may also impact verification procedures. Forexample,aflatoxinmaybeahazardrequiringapreventivecontrolincornmeal.Themosteffectivecontrolsforaflatoxinareappliedduringproduction, harvest and storage of the corn prior to milling. Thusupstream verification procedures for aflatoxin preventive controlsmaybeappliedbyamillerwhowouldalsoapplypreventivecontrolsintheiroperationbasedonrisk.However, fartherdownthesupplychain(e.g.,companiesusingcornmeal),aCertificateofAnalysis(COA)fromthecornmealsupplierorperiodictesting foraflatoxinmayberelevant.

Knowledge of your supplier’s procedures, processes and practicesrelatedtofoodsafetymayalsoinfluenceverificationprocedures.Forexample,asupplierthatproducesonlypeanutswouldnotbeamajorconcernfornon‐peanutallergensbecausetheyonlyhandlepeanuts.However, a supplier that makes a variety of nut products withdifferentkindsofnutsmaypresentahigherriskbecausetreenutsofdifferent varieties have different allergens present. Understandinghow such a company controls allergensmay be important to yoursupply‐chainprogram.

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Another consideration is a supplier’s compliance historywith FDAregulations. Warning letters and import alerts for a supplier maywarranttakingextraprecautionstoverifythatadequatecontrolsareinplace.Countryoforiginmaybeaconsiderationaswell.

An ongoing relationship with a supplier is another importantconsideration. Some companies have many years of positiveexperiencewithaspecificsupplier,whichmayreducetheextentofverification activity needed. Conversely, constantly switchingsuppliersforaningredientrequiringasupply‐chainappliedcontrolmaywarrantheightenedverificationactivity tobuild confidence inthesupplier’sabilitytomeetyourfoodsafetyrequirements.

Theremaybeother factors toconsider, suchas transportationandstorage methods used by the supplier, e.g., when a food requiresrefrigerationforsafety.

Forverysmallbusinesses,farmsandshelleggproducers(asdefinedby FDA), supplier verification activities are limited. The receivingfacility must obtain written assurance that the supplier retains itsregulatory status before approving the supplier and annually byDecember31,andatleasteverytwoyearsthereafterobtainwrittenassurancethequalified facilitycomplieswithapplicablefoodsafetyregulationsorthatfarmsacknowledgethatthefoodissubjecttotheadulterationprovisionsoftheFD&CAct.Ifthisappliestoyou,see21CFR 117.430 for specific requirements. For these suppliers, areceivingfacilitymayusetheabsenceofwarninglettersorotherFDAcomplianceactionsindeterminingwhethertoapprovethesupplier.

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Conducting Supplier Verification Activities

Only the receiving facility can approve suppliers; however, otherentities can determine and conduct other activities. The receivingfacilitymustreviewandassesssupplierverificationactivitiesthataredeterminedbyand/orconductedbyanotherentity,anddocumentthereviewandassessmentactivity.Asuppliermayprovidetestresultsfor the lots that they send to you (the receiving facility) for yourreviewandassessmentasa supplierverificationactivity.However,you cannot rely on a supplier’s determination of appropriateverification activities for its own product – you need to determineappropriate verification activities that are consistentwith the foodthat you are producing. Thus, test results from a supplier are onlyacceptableifyouhavedeterminedthisisanappropriateverificationactivityforthatfood.Similarly,asupplier’sself‐auditorasupplier’sreviewoftheirownrecordsarenotappropriatesupplierverificationactivities.However,asuppliercanprovideanauditconductedbyaqualified third‐party auditor if you have determined this is anappropriateverificationactivityforthatfood.

As noted above, another entity, such as a broker, may performsupplier verification activities for review and assessment by thereceiving facility. Remember, the supplier is the entity thatmanufacturestheproduct,growsthefoodorraisestheanimal;thusabrokerisnotasupplierinregulatoryterms.Anentityotherthanthereceivingfacilitymayestablishwrittenproceduresforreceivingrawmaterials and ingredients from suppliers; document that thereceiving procedures are followed; and determine, conduct anddocument appropriate supplier verification activities for thosematerials.Thereceivingfacilitymaythenreviewandassesstheotherentity’sdocumentationtoverifythatthesupply‐chain‐appliedcontrolwasappropriatefortheirfoodsafetysystem.

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Onsite Audits

Unless you have documentation justifying that other verificationactivitiesprovideadequateassurancethathazardsarecontrolled,anonsiteaudit isrequiredwhenthere isareasonableprobabilitythatexposuretoaserioushazardrequiringasupply‐chain‐appliedcontrolwillresultinseriousadversehealthconsequencesordeath.Theauditis required before using the ingredient and at least annuallythereafter.

oumay be able to provide documentation that suggestswhy lessfrequentauditingisadequatetoassurethatcontrolsareinplace.Forexample, youmay be able to demonstrate that an audit every twoyears combinedwith periodic testing provides adequate assurancethatthesupplieriscontrollingthehazard.

Definition: Qualified auditor: A person who is a qualified individual as defined by this part and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function required by 117.180(c)(2). Examples of qualified auditors include: (1) A government employee,

including a foreign government employee; and

(2) An audit agent of a certification body that is accredited in accordance with regulations of part 1, subpart M of this chapter [21 CFR].


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Theauditmustbeconductedbyaqualifiedauditorwhohastechnicalexpertisetounderstandthehazardidentifiedinyourhazardanalysis,theeffectivenessofcontrolsforthathazardandtherequirementsofthePreventiveControlsforHumanFoodsregulation.Itisimportanttoensure that audits include both records review and observation ofpracticesforacompletepicture.Comprehensivesystemsauditsthatinclude records reviews are more likely to reflect conditionsthroughouttheyearthananinspectionfocusedonlyonthestateofthe facility at the time of the inspection. The audit must addressprocess, allergen, sanitation and supply‐chain‐applied controls, aswell as GMPs, as applicable, or, in some cases compliance toregulations such as the produce safety regulations. The auditmustalsoaddressthespecifichazardsidentifiedinyourhazardanalysis.

Somecompaniesusetheirownqualifiedemployeestoauditsuppliers(a “secondpartyaudit”). Suchauditsallow firsthandreviewof thecriticalfoodsafetyprogramsandpreventivecontrolsinplaceatthesite. One can obtain a sense for how effective programs are bydiligently reviewing program records, observing activities andinterviewinglineworkers.Whilethistypeofauditallowsacompanytoverify that their specific requirements arebeingmet, it requiresinternal resources and expertise thatmaynotbe feasible for somecompanies.Auditsconductedbyanindependentthirdpartymayalsobeused. oursuppliermaybeabletoprovideathirdpartyauditforyourreview.

Somesuppliersareroutinely inspectedbyFDAorotherrecognizedgovernmentagencies.Thus,youmaybeabletorelyontheresultsofthese inspections instead of a private party audit and obtaininformationontheseinspectionsannuallyfromthesupplier.Keepinmindthattheseinspectionsmaynotoccurannually.

Sampling and Testing

The Global Food Safety Initiative is an example of benchmarked auditing programs (aka “schemes”) for food safety standards.

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Testingof in‐processmaterials, environmental samplesor the foodproducedbythesupplier,eitheratthesupplier’sfacility,atanoutsidelaboratory or in your facility may be appropriate if such testingprovidesmeaningfulresultsrelatedtocontrolofahazardrequiringapreventive control. This test information would be captured in aCertificationofAnalysis(COA).Itisimportanttousemethodsthatarefit for purpose and understand the limitations of testing due tosamplingprobability. ourapproachshoulddependonthepotentialhazardsandthecontrolsinplaceforthespecificproduct.Testingfornew supplier approval is usually more extensive than formaintenanceofapprovedsupplierstatus.

It is advisable to consult a reference book (e.g., ICMSF, 2011), atechnicalexpertorothercrediblesource(seeChapter7:ResourcesforPreparingFoodSafetyPlans)todetermineappropriatetestingandsampling plans for different types of food products. Sometimesindicator tests provide more useful information to verify processcontrolthanpathogentesting.Forexample,coliformtestingisusedby the dairy industry to verify the effectiveness of the overallpasteurization system, including sanitation, rather than testing forpathogens.

Other Verification Activities

Other activities that may be useful for supplier approval andverification depend on the hazards you are managing. Manycompanies require their vendors to provide a Continuing ProductGuaranteecertifyingthattheproductmeetscompanyrequirements,includinglegal,regulatoryandconformancetospecifications.Thesecertificates generally cover multiple shipments or timeframes andshould be reviewed and renewed at least annually or whenrequirements change. These generally do not serve as verificationactivitiesinthewaythatauditsortesting(e.g.,COAs)do,butmaybe

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suitable for certain ingredients, such as those with frequentgovernment inspection. Further, they would not be the soleverificationactivityforcompliancewiththeregulatoryrequirements.Copiesofproductionrecordscouldalsobereviewedtoverifythatthehazards were controlled and that material was produced to yourspecification.

Non‐conformance

Whenanaudit,otherverificationactivity,relevantcomplaintorotherinformation identifies a gap in supplier performance related to ahazardrequiringapreventivecontrol,youmustensurethatthefoodyouhavemanufacturedisnotadulteratedormisbrandedwithrespecttoallergensasaresultofthesuppliernotadequatelycontrollingthehazard. Corrective actions will vary depending on the issue aspreviously discussed in the other chapters on other preventivecontrols.

Because system failures can occur in the supplier’s process orprocedures from time to time, the suppliermust have a correctiveactionprocess formakingmodificationstopreventreoccurrenceofan issue. ou must ensure that the intended corrective action isactually implemented. In addition, you must evaluate all affectedproductforfoodsafetytoensurethatadulteratedfooddidnotenterinto commerce. If adulterated product did enter commerce, then arecall would be required (see Chapter 15: Recall Plan). Correctiveaction is discussed in other chapters, including documentationrequirementsinChapter14:Record‐keepingProcedures.

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Supply‐chain Program Review

Itisgoodbusinesspracticetoevaluateyoursupply‐chainprogramona routine basis (typically annually). Comparing findings from yoursupplier approval, verification and corrective action processesagainst the safety requirements in the supplier specifications andcontractmay indicate theneed forchange.Rawmaterialandotheringredient specifications should clearly communicate food safetyrequirements to the supplier, aswell as identify these hazards foryourownunderstandinganduseinyoursupply‐chainprogram.

Ifafoodsafetyissueoccurswithyourproduct,reviewyoursupplierprogram, including verification activities, to ensure that programinadequacy was not the cause. For example, you may not haveidentifiedahazardthatisassociatedwithaningredientthatneededto be controlled by the supplier. Also verify that the supplier tookstepstopreventrecurrenceofissues,whenapplicable.

ouoryoursuppliermaycreatenewformulationsornewprocesses.Anyingredientchangeshouldbereviewedtoensurethatfoodsafetyrequirements are still met by the supplier if the ingredient isassociated with a hazard requiring a preventive control. Similarly,new hazards are periodically identified – ensure that your supply‐chainprogramisadequate toaddressnewhazardsassociatedwiththerawmaterialorotheringredientthatthesupplierprovides.

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Changeisanecessarypartofthebusinessprocess.Havingproceduresin place to accommodate changes can help avoid food safety orpotentially disruptive supply‐chain issues. Two aspects of changeshould be considered relative to suppliers – changesmade by thesupplierandchangesmadebythereceivingfacility.Ifsuppliersmakeachange to the ingredients that theyprovide, the foodsafety teamshouldbe informedtoallowreanalysis todetermine if changesareneededtotheFoodSafetyPlanorsupply‐chainprogram.Frequentlysupplier communications are handled by purchasing; thus thepurchasingteammustforwardrelevantinformationtothefoodsafetyteam.Thesuppliermustunderstandtheimportanceofreportingallchangestocustomerssotheycananalyzethechangewithrespecttotheiruseoftheingredient.

Conversely,youoryourpurchasingteammayidentifyanewsupplierthatcanprovideasimilar ingredient. It isessential thatpurchasingnot make a switch in suppliers of an ingredient or raw materialassociatedwithahazardrequiringasupply‐chaincontrolwithouttheauthorization of the food safety team. The new supplier must beapproved if the ingredient is associatedwith a hazard requiring asupply‐chain‐applied control. Again, it is important to consider theresourcesneededtoreviewsupplierprogramsfornewsuppliersfromafoodsafetyperspectivebeforeswitchingsuppliers.ReanalysisoftheFoodSafetyPlanmayalsoberelevantforcompany‐initiatedsupplierchanges, especially those for ingredients with hazards requiring apreventivecontrol.

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Documenting the Supply‐chain Program

Regulators, auditors and customers view records as the historicalmethodforconfirmingaprogramisinplaceandfunctional.Withoutrecords,onecannotdemonstratesupplierprogramsareimplementedasdesignedandareeffectiveincontrollinghazards.Thisdiscussionisaboutrecordsforyourpreventivecontrolssupply‐chainprogram.

A document on your supply‐chain program is the starting point todescribehowthe facilitydevelopsand implements itssupply‐chainprogram. If the facility isan importer, thendocumentation that thefacilityisincompliancewiththeforeignsupplierverificationprogramrequirementsunder21CFR1SubpartLisrequired.

oumustmaintaindocumentationoftheapprovalofyoursupplier(s)that provide ingredients requiring a supply‐chain‐applied control.Thereceivingfacilitymustalsohavewrittenproceduresforreceivingrawmaterialsandingredientsandmaintainrecordsthatdemonstratethatallrawmaterialsandotheringredientswithhazardsrequiringasupply‐chain‐appliedcontrolarereceivedfromapprovedsuppliers.

oumust document the determination of the appropriate supplierverification activities youwill conduct for rawmaterials andotheringredients requiring a supply‐chain‐applied control.Onsite audits,samplingandtesting,reviewofsupplier’srelevantfoodsafetyrecordsorotherapproachesmaybeidentified.

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Recordsoftheonsiteauditsforapprovedsuppliersarerequired.Thereportmustincludethesuppliername,auditprocedures,thedate(s)theauditwasconducted,theconclusions,andcorrectiveactionstakenin response to significantdeviations identified.Documentation thatdemonstratesthattheauditwasconductedbyaqualifiedauditorisalso required,which could be a receiving facility’s employee if theemployeemeetsthequalifiedauditordefinitiondiscussedpreviously.

Records of sampling and testingmust identify thematerial tested,including the lot number as appropriate and number of samplestested.Thetestsconductedandanalyticalprocedureused, thedatethetestswereconductedandtheresultsmustbedocumented,usuallyonthelaboratorytestform,whichwouldalsospecifythelaboratory

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conducting the tests. Corrective actions, if any, must also bedocumentedinresponsetothedetectionofhazards.

When the receiving facilityor audit teamreviewsa supplier’s foodsafetyrecords,thereceivingfacilitymustdocumentthenameofthefacility, date of the review, conclusions of the review, correctiveactions,ifany,inresponsetodeficienciesidentifiedduringreview.

Ifverificationactivitiesother thanthoseaboveareused, theymustalsobedocumented.Theslideabovelistsotherdocumentsrequiredif applicable to your facility. Supplier non‐conformance documentswould apply to all facilities. Refer to Chapter 14: Record‐keepingProceduresforrecordretentionrequirements.

Supplier Controls Summary

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In summary, a supplier program is an essential element of a foodsafetysystem. oursupplieristheentitythatmakesorgrowsthefoodor raises the animal you (the receiving facility) use to make yourproduct.Thehazardanalysisprocess identifieshazards requiringasupply‐chain‐appliedcontrolforwhichasupply‐chainprogrammustbeimplemented.

The supply‐chain programmust include using approved suppliers,and determining, conducting and documenting supply‐chainverificationactivities.Verificationactivitiesmayincludeonsiteaudits(required for serioushazardsunlessanotherapproach is justified),sampling and testing, review of a supplier’s relevant food safetyrecords,andotheractivitiesbasedonrisk.Recordsthatdocumentallof these activities must be maintained to demonstrate that yoursupplierprogramisoperationalandeffective.

AdditionalReadingFDA2014,ForeignSupplierVerificationPrograms(FSVP)forImportersofFoodfor

HumansandAnimals.FDA2015.InterstateMilkShippersList.AvailableatInterstateMilkShippersICMSF(InternationalCommissiononMicrobiologicalSpecificationsforFoods).

2011.MicroorganismsinFoods8:UseofDataforAssessingProcessControlandProductAcceptance.Springer,New ork

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NOTES:

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CHAPTER 13. Verification and Validation Procedures

Verification is another essential part of a preventive controlsapproachforfoodsafetysystems.Thischapterexplorestheconceptsofverificationandvalidation,andproceduresassociatedwiththeseactivities. Verification is an important component of supply‐chain,sanitation,allergenandprocesspreventivecontrols.ItconfirmsthattheFoodSafetyPlanisoperatingasintended.Validationconfirmstheeffectiveness of the Food Safety Plan in controlling food safetyhazards.ThepurposeofverificationistoprovidealevelofconfidencethattheFoodSafetyPlanis1)basedonsolidscientificprinciplesthatareadequatetocontrolthehazardsassociatedwiththeproductandprocess,and2)thattheplanisbeingfollowedcorrectlyeverydayofoperation.Apreventivecontrolsqualifiedindividualmustperformoroversee validation and most verification activities. This chaptercovers elements of verification, including validation, calibration,product sampling and testing, record review, andFoodSafetyPlanreanalysis.Alloftheseareverificationactivities.

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Both verification and validation are essential for an effective foodsafetysystem.Routineverification isanongoingprocesstoprovideevidencethattheplanisbeingproperlyimplementedandoperatingasintended.Validationisdemonstratingthatfollowingtheplanwillactually control the identified hazards. Thus, validation should bedone before implementation of the Food Safety Plan. This is oftendescribedasaninitialvalidation.

Thereareseveraltypesofverificationactivitiesandprocedures,butrequirementsandapplicationdependonthefood,processesusedandother factors.Validation (i.e.,makingsure that theprocessactuallycontrols the hazard) is required for most process controls whenhazards requiring a preventive control are identified. Validation,when required, is preferably done before the plan is implemented

Sometimes verification and monitoring activities can appear to be the same thing. For example, an operator that is cleaning equipment may record observing the equipment is visibly clean as a monitoring activity prior to completing their task. A supervisor may then visually inspect the equipment as a verification activity, confirming that the equipment was cleaned. The important thing is that the activity is done and recorded, rather than what it is called.

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(discussion follows). Other elements of verification are typicallyongoing procedures that may be regularly scheduled, such ascalibrationofequipment(e.g.,thetemperaturemonitoringdevicefortheovenusedtocookaproduct)orrecordreviews(e.g.,toshowthattheoventemperaturewasatorabovethetemperatureneededtokillthepathogenofconcern).Someverificationactivitiesaredone lessfrequently, such as periodic in‐process or end product testing,internalaudits,third‐partyauditsandareanalysisoftheplanwhenchangesaremadeoratagivenfrequencytoensurethattheplanstillreflects what happens at the facility. As with validation, requiredverificationactivitiesvary,dependingonthefood,facilityandotherfactors. Regulatory inspections are yet another type of verificationactivity in which the inspector reviews the adequacy of the FoodSafety Plan, determines if it is being properly implemented, andreviewsrecordstoseeifparametersandvaluessuchascriticallimitsarecontinuallymetandcorrectiveactionsareadequate.

Validation

Thepurposeofvalidationistoprovideobjectiveevidencethatprocesspreventive controls have a scientific basis and represent a “valid”approachtocontrollingthehazardsassociatedwithaspecificproductand process. This includes demonstrating that the equipment candeliver the process as designed and that the design parametersactually will control the hazard requiring a preventive control.StrategiesthatcanbeusedtovalidatetheFoodSafetyPlaninclude:

x usingscientificprinciplesanddatafromtheliteraturex relyingonexpertopinionx conducting in‐plantobservationsor testsat the limitsof its

operatingcontrolsx usingmathematicalmodels

Validation o Does it actually control the hazard?

Documentation is needed to demonstrate that procedures in place actually control the hazard.

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x incorporatingregulatoryguidelines

Becauseofthescientificconceptsinvolvedinvalidation,thiselementofpreventivecontrolsmustbeperformedoroverseenbyapreventivecontrols qualified individual. This person does not have to be anemployeeofthecompany.

Ideally, an initial validation of process preventive controls shouldoccurbefore theFoodSafetyPlan is implemented.Thismaynotbepossibleinsituationswhereprocessvariationmustbeevaluated,thuscontinued validation activities may be necessary. The PreventiveControls for Human Food regulation requires that validation ofprocesspreventivecontroliscompletedwithinthefirst 0calendardays of production. A longer period in a reasonable timeframe isallowedifthepreventivecontrolsqualifiedindividualoverseeingthevalidation provides written justification for the longer timeframe.Processorsmaywanttoholdproductproducedbeforevalidationdataare complete to ensure that the process is effective in controllingidentifiedhazards.

Revalidationmayberequirediftheprocessorproductischangedinaway thatmay impact the effectiveness of the process. Reanalysis(discussed later in thechapter)mayalsodemonstrate theneed forrevalidation.

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ThePreventiveControlsforHumanFoodregulationdoesnotmandatevalidationof foodallergencontrols, sanitationcontrols, thesupply‐chainprogramortherecallplan.However,productrecallshavebeenassociated with undeclared allergens in products, thus validatedcleaningproceduresfordifficulttocleanequipmentmaybeusefultoassure that the procedures are effective in removing allergenresidues.

Validation of the effectiveness of sanitizers to kill pathogens isconducted when the chemical manufacturer registers the productwith the Environmental Protection Agency (EPA) or similarregulatoryagenciesinothercountries.Thisvalidationdemonstrateseffectivenessofthesanitizerorsterilantwhenusedaccordingtolabelinstructionsanditisaviolationoffederallawtousesuchproductsinamannerthatisnotconsistentwiththelabel.Thus,followinglabelinstructionsonregisteredsanitizersandsterilantsisthefirststepinvalidation. Suppliers of cleaners and sanitizers often validate theseproducts with respect to cleaning particular soils and eliminatingcertainpathogens,thusfollowingtheirestablishedproceduresisalsoimportant. A facility may choose to validate that the frequency ofcleaningisadequatetocontrolhazardsintheiroperationtopreventproductsafetyissues.

Writtenjustificationthatvalidationisnotapplicabletoapreventivecontrol may be prepared by the preventive controls qualifiedindividual. Thismay be based on factors such as the nature of thehazard,thenatureofthepreventivecontrolanditsroleinthefoodsafetysystem.

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Afewsourcesofinformationthatcanbeusedforvalidationstudiesarelistedabove.TheFSPCAwebsitehaslinkstoinformationthatmaybe useful.While companies that have technical experts are able toconductvalidationstudiesthemselves,manycompaniesuseexternalresourcestoobtainscience‐basedvalidationdata.

An example of the type of information that may be used tosubstantiatevalidationactivitiesistheabovetablefromanInstituteofFoodTechnologistsreportcommissionedbyFDA(IFT2001).Anaccepteddatasourcesuchasthisissometimescalleda safeharbor. The IFTtable isbasedonascientificevaluationof thepotential forgrowth of or toxin formation by foodborne pathogens underotherwise ideal conditions. Productswith a pH of 4.2 or a wateractivity (aW) 0.88 are not reasonably likely to support foodborne

The FSPCA website updates links to useful information for validation and other purposes.

Firms are responsible for confirming the applicability of this information to their specific situation.

The IFT 2001 report also provides similar information for products that are heat treated in which only spores must be controlled.

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pathogengrowthevenwhenproductsareheldatoptimumgrowthtemperatures. Various combinations of pH and aWmay also inhibitgrowth, but combinations, such as a pH 5.0 and aW 0. 2 requirefurtherstudytoruleoutgrowth,accordingtothetableabove.

Safeharbordataareusefulbutmustbeappliedinthecontextoftheproductcharacteristics,thepathogensofsignificanceandtheprocesscontrolsthatareapplied.AfoodestablishmentcouldusethistabletosupporttheirconclusionthatpathogengrowthintheirproductisnotlikelyiftheproductpHandaWcombinationfallsinthe“Nogrowth”areaofthetable.Forsomeproducts,thepHandaWparametersmaybe preventive controls that would require documentation (e.g., aformulatedproduct).Inotherswherethisisanaturalcharacteristicoftheproduct(e.g.,saltandsugarhaveanaturallowwateractivity;vinegarhasanaturallylowpH),managementasaprocesspreventivecontrolisnotnecessary.

The E.G. Food Company cooks their omelets to a temperature oft160 F(71 C) forquality reasons (anoperating limit),because theomelet batter must be congealed in order to transfer it to theAssemble/Wraptable,whereit isrolledandplacedintoatray.Thecompany worked with a consulting food safety expert to do avalidation study for their cooking procedure. The consultantconducted studies that showed the temperature of the omeletwasalways above 158 F (70 C), as measured using an infraredthermometer, when the omelet batter was congealed. Theirconsultantwroteareport,whichtheyincludedintheirFoodSafetyPlan(seeAppendix3:FoodSafetyPlanExample–Omelet).

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Verification Procedures

Verificationprovidesevidence todemonstrate that theFoodSafetyPlanisworkingandbeingimplementedaswritten.Severaltypesofverificationactivitiesmaybenecessaryforeachpreventivecontroltoensurethattheproceduresusedareeffective.

Ongoing verification actives such as calibration of monitoringinstrumentstoensuretheiraccuracyandperiodicin‐processorendproduct testing to verify process control are important in showingthat the Food Safety Plan works. As discussed in Chapter 11:Sanitation Preventive Controls, environmental monitoring is averification activity to demonstrate that sanitation preventivecontrolsareeffectiveinfacilitiesthatproduceready‐to‐eatfoodthatisexposedtotheenvironment.

Supervisoryreviewofmonitoring,correctiveactionandverification(e.g., calibration and product testing) records is another type ofverificationthatisusedtodemonstratethattheFoodSafetyPlanisbeing implemented as intended. Verification of supply‐chainprogramswasdiscussedinChapter12:Supply‐chainProgram.

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Calibration of Monitoring Equipment

Routine accuracy checks and periodic calibration of monitoringdevices are verification activities used to ensure that themeasurements taken by the monitoring devices are accurate andreliable. Accuracy checks and calibration are fundamental to thesuccessful implementationandoperationoftheFoodSafetyPlan. Ifmonitoring devices do not provide accurate measurements, thenmonitoringresultsareunreliable.Ifmonitoringequipmentisfoundtobe out of calibration, a process preventive control should beconsidered out of control since the last documented acceptableaccuracycheckandcalibration.Correctiveactionshouldbetakentoevaluate the safety and determine appropriate disposition of theproduct(seeChapter :ProcessControl,CorrectiveActionsection).

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Calibration and accuracy checks are different but related concepts.Ideallyameasurementdeviceisbothaccurate(correctortrue)andprecise(repeatableorreproducible).Theaccuracyandprecisionofameasurementisusuallyestablishedbymeasuringagainstatraceablereferencestandard.Calibrationinvolvesdeterminingthatthevalueofeachreadingonaparticularmeasuringinstrumentisinfactcorrect,by measurement against a known calibrated instrument orcomparisonwithtwoknownstandards.Forexample,athermometercould be calibrated by comparing it to a National Institute ofStandards (NIST) traceable thermometer at two differenttemperaturesintherange(aboveandbelow)inwhichitwillbeused.Accuracy checks determine if the instrument is reading a true orcorrect value at a single point. Routine accuracy checks of athermometer used to measure cold temperatures could involveimmersingtheprobeinanice‐slurrytodetermineifthethermometermeasuresatemperatureof32 F(0 C).Boilingwatercouldbeusedfora thermometer used to measure hot temperatures. Because theboilingpointofwatervarieswithaltitude, thespecific temperatureneedstobedetermined.

Calibration is typically done less frequently than accuracy checks.Examplesofcalibrationactivitiesandaccuracychecksarepresentedintheslideabove.

Itisimportanttorealizethattheaccuracyofmonitoringdevicescanchange, therefore it is important to conduct routine accuracy andperiodiccalibrationcheckstoassuresafetyandtominimizetheneedto detain and evaluate product. A number of factors should beconsidered when determining the frequency of these activities formonitoringdevices.

Thedesignofthemeasuringinstrumenthastoensurethatthedeviceiscapableofmakingaccuratemeasurementswhenusedwithin the

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expected environmental condition over some reasonable period oftime.Calibration frequencydependson the typeofdeviceused, itsconditionandpastperformance,aswellastheoperatingenvironmentinwhichitwillbeused.Forexample,someinstrumentsareaffectedby temperature or humidity. The reliability and sensitivity of themonitoringinstrumentshouldalsobeconsideredwhendeterminingthe frequency of accuracy checks and calibration. Consistenttemperature variations away from the actual value (drift) foundduringchecksorcalibrationsofatemperaturemeasuringdevicemayindicatethatmorefrequentcalibrationisneededorthedeviceneedstobereplaced,perhapswithamoredurabledevice.

Oneofthemostfrequentlyusedmonitoringdevicesforfoodproductsis a thermometer. Some factors to considerwhen determining thefrequencyforthermometeraccuracychecksandcalibrationinclude:

x Inherentreliability:Dailyaccuracychecksmaybeneededfortheleastreliableinstruments(i.e.,dialthermometersandbi‐metallic types). Periodic checksmay be adequate for morereliableinstruments(i.e.,digitalthermometerswithahistoryofgoodperformance).

x Manufacturer recommendations: The design and expectedconditions of use for each individual product is consideredwhen manufacturers make accuracy and calibrationrecommendations. This information should be used todeterminethefrequencythatisneededfortheseactivitiesintheFoodSafetyPlan.

Equipment Calibration Example E.G. Food Company uses an infrared thermometer to measure thetemperature of the cooked omelet as a verification activity. Theaccuracy of the thermometer is therefore important to check. Thefoodsafetyteamincludedthefollowingverificationactivities intheFoodSafetyPlantoassurethatthethermometerwasaccurate:Dailyaccuracy check for thermometer. Annual calibration ofthermometer

See Flores and Boyle 2000 in Additional Reading for a reference on thermometer calibration, including forms.

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Recordsmustbekepttodocumenttheresultsofaccuracychecksandcalibrationsofmonitoringdevices.Theserecordsmustbereviewedbyapersonwhohasthetrainingorexperiencenecessarytoevaluatethe results and determine that all monitoring instruments areaccurate and properly calibrated. The regulation does not requirerecords to provide traceability to a reference device, but this is auseful practice. See the subsequent section on verification recordsreview.

Product Sampling and Testing

Verification may also include targeted sampling, testing and otherperiodicactivities.Forexample,suppliercompliancewithastandardmay be verified by targeted periodic sampling and testingwhen a

See the FSPCA website for links to guides and posters for thermometer calibration.

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supply‐chain program includes testing of an ingredient or rawmaterialasverificationofasupply‐chain‐appliedcontrol.

When a monitoring procedure does not involve a quantitativemeasurement,itshouldtypicallybecoupledwithastrongverificationstrategy.Forexample,visualobservationofcleanequipmentcouldbeverifiedthroughperiodictestingusingamethodsuchasanATPswab.Similartocalibrationrecords,sampletestresultsmustbereviewedwithinareasonabletimeaftercompletingthereports.Thesereviewsarepartofthefacility’sverificationactivities.

Examplesofperiodic targeted samplingand testing for verificationpurposesmayinclude:

x Coliformtestingforpasteurizedmilkproductstoverifythattheprocessmeetsrequirementsforsafetyandthatsanitarypracticeisadequate.

x Testing dry corn for aflatoxin, especially when seasonalconditionsincreasetheriskofaflatoxinproduction.

x Pesticideresiduetestingofrawfruitsorvegetablesusedforfurtherprocessing,especiallyfromnewsuppliers.

WhentheFoodSafetyPlanspecifiesproducttestingasaverificationactivity,youneedtodocumenttheprocedurestobefollowed.Ensurethatthetestmethodsarescientificallyvalidbyusingstandardmethodpublished by international, regional or national standards‐writingorganizations such as the FDA, AOAC, ISO, etc. Documentedprocedures for the testing program must identify the informationabove.

x Identifythespecificmicroorganismoranalytetobeevaluated.Testing may be for pathogens or for relevant indicatororganisms,whichmayprovidequantitativeinformationthat

Examples of organization that publish scientifically valid methods for examination of food include: x Official Methods of

Analysis of AOAC International

x American Public Health Association (APHA) Compendium of Methods for the Microbiological Examination of Foods

x APHA Standard methods for the examination of Dairy Products

x the Pesticide Analytical Manual (PAM)

x the Food Additives Analytical Manual

x the Food Chemicals Codex x FDA Bacteriological

Analytical Manual (BAM) x FDA Macroanalytical

Procedures Manual (MPM) x ORA Laboratory

Information Bulletins (LIBs) x International Standards

Organization (ISO) methods

The E.G. Food Company Food Safety Plan includes a product testing example.

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ispotentiallymoreusefultoassessthemicrobiologicalstatusofalot.Forexample,thepasteurizedmilkindustryhasusedcoliforms as an indicator in milk products for many yearsratherthanpathogentesting.Adequatepasteurizationshoulddestroy coliforms, thusdetecting coliforms in apasteurizedmilk product suggests post‐process contamination orinadequatepasteurizationconditions.Afacilitycanactonthisinformation, especially if data are analyzed over time toevaluatetrends.

x Identifythespecificlotorlotsthatthesamplerepresents.Forexample,ifthesampleisaningredient,preferablytheanalysisisdonebeforetheingredientisusedinaproduct.Ifnot,thenidentifywhichlot(s)ofproductcontainedtheingredient.Ifitisalinesample,thesamplemayrepresentproductmadesincethelastcleanup.

x Samplingplansfrequentlyspecifythenumberofsamplestobe taken throughout a lot. ICMSF (2011) providesconsiderationsandrecommendsformicrobiologicalsamplingplansforavarietyoffoodproducts.

x The actual testmethod usedmust be scientifically valid asdiscussedabove.Ensurethatthemethodhasbeenvalidatedfor thespecific foodunderconsideration.Methodprovidersmaybeofassistanceinvalidatingthetestmethod.

x our procedures must identify the laboratory that willconduct the test. oumay conduct your own testing if youhavetheappropriatefacilitiesandtrainedindividuals.Manytimesanoutsidelaboratoryisused.Ensurethatthelaboratoryhasproficiencyinworkingwithfoodsamples.

x ourproceduresshouldidentifycorrectiveactionproceduresthatwillbe followedif testresultsdonotcomplywithyourstandards.

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Environmental Monitoring

Environmental monitoring is used as a verification procedure forsanitationcontrols,especially in facilities thatproduceready‐to‐eatproducts that are exposed to the environment. The procedures forenvironmentalmonitoringmustdocumentsimilarelementstothosefor product sampling, including the test microorganism(s), thelocationandnumberofsitestested,howoftenandwhen(e.g.,duringproduction,aftercleaningorothertiming),theanalyticalmethod,thelaboratoryusedandcorrectiveactionprocedurestobefollowedifapositive result is obtained. See Chapter 11: Sanitation PreventiveControls and Appendix 5B: Hygienic oning and EnvironmentalMonitoringformoredetailonenvironmentalmonitoring.

Verification Record Review

Definition

RTE (Ready‐to‐eat) food: Any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.


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All monitoring and corrective action records should be reviewedundertheoversightofapreventivecontrolsqualifiedindividual.Thisreviewisaverificationactivity.Theserecordsarevaluabletoolsthatdocument that theFoodSafetyPlan isoperatingwithinestablishedsafety parameters and that deviations are handled appropriately.However, records alone are meaningless unless someone reviewsthemonaperiodicbasisto“verify”thatcriticallimitsweremetandthe Food Safety Plan is being followed. Regulations require thatmonitoringandcorrectiveactionrecordsbereviewedwithinseven(7) working days under the oversight of a preventive controlsqualified individual. Preferably the records are reviewed prior torelease of product to prevent potential recall and unintendedconsequencesshouldadeviationbediscoveredduringrecordreview.Correctiveactionmustbetakeniftherecordreviewdeterminesthatadeviationhasoccurred.Thismayholdtrueforsanitationpreventivecontrols records if, for example, the product is no longer in theestablishment’scontrolandthelackofproperimplementationofthepreventivecontrolmayleadtoahazardbeinglikelytooccurintheproduct.

Thevalueofrecordreviewismaximizedwhenthedataareanalyzedto look for trends. For example, are theverification results foronesupplierthesameasanothersupplier,oraretheredifferencesthatwarrant investigation AreListeria indicators isolatedwith greaterfrequencyinonelocation Dosanitationverificationresultsindicatehighercountsononelineorinonearea Ifatrendemergesduringrecord review, adjustments may be warranted to minimize thepotentialforafuturedeviation.Arigorousverificationprogramcanbethebasisforcontinuousimprovementofoperationsandleadtoamoreeffectivefoodsafetysystem.

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Verification Example

AnexampleoftheProcessControlverificationactivitiesperformedbythe E.G. Food Company is illustrated above. Verification activitiesinclude:1)reviewoftheCookLog,correctiveactionandverificationrecords within 7 working days and 2) daily accuracy and annualcalibration checksof the thermometerused for verification checks.Theproceduresusedtoperformthesevalidationactivitiesshouldbedocumented.

Food Safety Plan Reanalysis

The E.G. Food Company Food Safety Plan also includes other examples of verification for sanitation and allergen preventive controls.

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InadditiontotheverificationactivitiesforCCPsandotherpreventivecontrols,strategiesmustbedevelopedforscheduledreanalysisoftheFoodSafetyPlan.Reanalysisisrequiredatleasteverythree(3)yearsorwheneverthereisasignificantchangeintheproductorprocess.Reanalysisisalsorequiredifinformationbecomesavailableaboutanew hazard associatedwith the food (e.g., FDA issues an advisorynotice)orifthereisafailurewiththesystemsuchasdiscoveringanineffective preventive control, an outbreak or similar situation. Inaddition, reanalysis is required when an unanticipated deviationoccurs; i.e., a specific corrective action procedure has not beenestablished. The preventive controls qualified individual isresponsibleforensuringthatthisverificationactivity(reanalysis)isperformedandtheymaycontractwithanindependentthirdpartytohelpconductsystem‐wideverificationactivities.

Significant changes in the product or process that may requirereanalysis (and sometimes additional validation) include when anevent or situation may alter the original conclusions. Examplesincludethefollowing:

x Rawmaterialchanges,includinganewsupplier,mayrequirereanalysistodetermineifthereisapotentialforfoodsafetyrelatedfunctionalpropertiestobealtered.Forexample,anewthickeningagentmaychangetheviscosityofaproduct,whichcould have an impact on heating characteristics for someproducts.Switchingsuppliersmayalsowarrantreviewofthenewsupplier’sallergencontrolstoassurethatanewhazardisnotintroduced.Theprocessmayrequirereanalysis.

x Product or process changes may warrant reanalysis. Forexample,reducingthelevelofsalt,whichcanaltermicrobialgrowthpatterns,mayrequireevaluationforsomeproducts.Intendedshelflife,processrequirementsandotherelements

”Significant changes” may include construction events, new equipment installation and the like.

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of the system may require reanalysis. If a new allergen isintroduced on a line, reanalysis of the procedures used tocleanthesystemmaybewarrantedtovalidatethatsurfacescanbeadequatelycleanedtoremoveallergens.

x Increasing production volumes that lead to extended runtimesmayprovidemoretimeformicrobialgrowthforsomeprocesses. The adequacy of sanitation to maintain sanitaryconditionsduringthisextendedtimemayrequirereanalysis.

x Adversefindingsduringreviewsorobservationofrecurringdeviations may suggest that the original validation is nolongeradequate.Thismaytriggerreanalysisofthefullsystem,including validationof elements of theprocess that arenotperforminginareliablemanner.

x Emerging scientific information on hazards or controlmeasures may also trigger reanalysis efforts. For example,whenE.coliO157:H7firstemergedasafoodbornepathogen,it was observed that it tolerates higher levels of acid thanmany other foodborne pathogens. Reanalysis of processlethalitywasneeded.

x New distribution or consumer‐handling practices may alsotriggerreanalysis.Forexample,ifanRTEproductdistributedto the general public though retail sales is subsequentlymarketed to infants, revalidation of controls to protect thismorevulnerablepopulationmaybewarranted.

VerifyingthattheFoodSafetyPlanisstillapplicableandrelevantisthefocusofreanalysis.Thisincludesthehazardanalysis.Reanalysisactivities also include onsite observations and record reviewsperformedbythefoodsafetyteamorotherunbiasedindividualsnotresponsibleforperformingthemonitoringactivities.ThisistoverifythattheFoodSafetyPlanisbeingfollowedanditmayidentifytrends

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thatneedtobeaddressed.Reanalysisshouldoccuratafrequencythatensures the Food Safety Plan is being followed continuously. Thisfrequencydependsonanumberofconditions,suchasthevariabilityoftheprocessandproduct.ActivitiesthatshouldbeconductedduringFoodSafetyPlanreanalysisinclude:

x Check the accuracy of the product description and flowdiagram.

x Check for new guidance or scientific information related tocritical limits or hazards that may require a change in thehazardanalysis.

x CheckthatpreventivecontrolsaremonitoredasrequiredbytheFoodSafetyPlan.

x Checkthatprocessesareoperatingwithinestablishedcriticallimitswithfew,ifany,deviations.

x Check that appropriate corrective actions have been takenandverificationactivitieshavebeencompleted.

x Checkthatrecordsarecompletedaccuratelyandatthetimeintervalsrequired.

x Review consumer/customer complaints related to foodsafety.

x Checkthatcorrectiveactionshavebeenperformedwhenevermonitoringindicatedadeviationfromcriticallimits.

x CheckthatequipmenthasbeencalibratedatthefrequenciesspecifiedintheFoodSafetyPlan.

x Checkthatequipmenthasbeenmaintainedsothattheprocessoperatesasoriginallydesigned.

x Checktobesurethatallrecordsarereviewedbyaqualifiedperson within 7 working days from the time they werecreated.

An independent thirdparty audit can also be included in a systemwideFoodSafetyplanverification.Thirdpartyauditorscanprovidean unbiased assessment to help determine if the plan is workingproperly. Experts may also need to be consulted to re‐validate aparticular processing step; e.g., when reanalysis identifies newinformationonahazardthatwasnotaddressedininitialvalidationstudies.

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Verification and Validation Summary

VerificationandvalidationareessentialelementsofaneffectiveFoodSafetyPlan.InitialandanysubsequentvalidationofthePlanmustbeoverseenbyapreventivecontrolsqualifiedindividualtoensurethatthecontrols identifiedwill control thehazards thatare likely tobepresentinthefoodwithoutsuchcontrols.VerificationactivitiesareconductedtoauditanddocumentthattheFoodSafetyPlanisbeingimplementedasdesigned,thatpeoplearedoingwhatisexpected,andthat records are available to demonstrate ongoing performance.Theseactivitiesmustalsobeperformedoroverseenbyapreventivecontrolsqualifiedindividual.Reanalysisisrequiredasneededandatleastevery3years.

Additional Reading Brackett,R.E.etal.(2014)ValidationandVerification:APractical,Industry‐driven

FrameworkDevelopedtoSupporttheRequirementsoftheFoodSafetyModernizationAct(FSMA)of2011.FoodProtectionTrendsNovember/December2014:410‐425.

FloresN.C.andE.A.E.Boyle.2000ThermometerCalibrationGuide.KansasStateUniversity.

ICMSF(InternationalCommissiononMicrobiologicalSpecificationsforFoods)2011.MicroorganismsinFoods8:UseofDataforAssessingProcessControlandProductAcceptance.Springer,New ork

IFT(InstituteofFoodTechnologists)2001.EvaluationandDefinitionofPotentiallyHazardousFoods.

NACMCF(NationalAdvisoryCommitteeonMicrobiologicalCriteriaforFoods)2004.Requisitescientificparametersforestablishingtheequivalenceofalternativemethodsofpasteurization.

Associate Professor

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NOTES:

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CHAPTER 14. Record‐keeping Procedures

Accuraterecord‐keepingisanessentialpartofasuccessfulpreventivecontrolssystem.Thischaptercoversrecordsthatarerequiredunderthe Preventive Controls for Human Food regulation, generalinformationrequiredontheserecords,examplesofimplementationrecords, how to review records and record keeping logistics.Regulatory implications related touseof computerizedrecordsarealsoaddressed.

The chapterdoesnot cover records thatmaybe requiredbyotherregulations,customers,auditorsorbusinessneeds.

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Ingeneral,therearetwotypesofrequiredrecordsinthePreventiveControlsforHumanFoodregulation–1)theFoodSafetyPlanitselfand2) implementation records. All of these documents are subject toreviewandcopyingbyregulatorypersonnel.

The components of the Food Safety Planwere discussed in earlierchapters.Essentially,theseFoodSafetyPlanrecordsdocumentwhatyouneedtodo.

This chapter focuses on implementation records. ImplementationrecordsdocumenttheactualimplementationoftheFoodSafetyPlan.In otherwords, implementation records demonstrate that you didwhatyouweresupposedtodo.Examplesofimplementationrecordsinclude, where applicable, records that document the actualmonitoringofpreventivecontrols,correctiveactionstaken,different

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verification activities performed, validation activities performed (ifneeded), the supply‐chain program checks and applicable trainingrecords.

The slide above from theE.G. FoodCompany’s FoodSafetyPlan inAppendix 3: Food Safety Plan Example, illustrates howimplementation records couldbe referenced in a FoodSafetyPlan.Thenameoftherecordforrecordingmonitoringactivityisincluded.Corrective action and verification records are also referenced,including the validation study for the cook step. These types ofrecordsarediscussedlaterinthischapterfollowinganoverviewofthegeneralrequirementsforallrecords.

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General Requirements for Records

Allrecordsmustbekeptasoriginalsortruecopies(i.e.,photocopies,pictures, scanned copies, microfilm, microfiche or other accuratereproductionsoforiginals)orinanelectronicformat.

MonitoringandverificationrecordsassociatedwiththeFoodSafetyPlanmustincludetheactualvaluesorobservation.Forexample,ifatemperature is being measured, the actual temperature must berecorded rather thana checkmark indicating that the temperaturecompliedwiththecriticallimit.Allrecordentriesmustbeaccuratelyrecorded in a permanent manner that can be read. For example,recordscannotberecordedinpencilbecausetheycanbechanged.

Theinformationmustberecordedatthetimeitisobserved.Inotherwords, it is not acceptable towalk out on to the production floor,observe practices and then go back to an office to record theobservations.Tocomplywiththeregulations,theinformationneedstoberecordedatthesametimetheactivityisbeingperformed.Therecordsneedtoincludeenoughdetailtoprovideahistoryoftheworkperformed.

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Electronic or computerized records are acceptable in a preventivecontrolssystemaslongastheyareequivalenttopaperrecordsandelectronic signatures are equivalent to traditional handwrittensignatures. Controls are necessary to ensure that records areauthentic, accurate and protected from unauthorized changes. If afirm intends to implement an electronic record‐keeping system,factorsthatmustbeconsideredinthedesignandimplementationofthesysteminclude:

x Electronicrecordsmustbeauthentic,accurateandprotectedfromunauthorizedchanges

x They must be reviewed by management with adequatefrequency to ensure the facility’s Food Safety Plan is beingfollowed.

x They must be available for review and copying by publichealthauthorities,ifnecessary.

If a facility decides to use an electronic or computerized record‐keepingsystem, thesystemshouldbevalidated just likeanyotherprocess or piece of equipment. Recent advances in electroniccommunications makes the use of portable electronic devicesattractivetoreducetheamountofpaperrecordsthatmustbekeptinafoodsafetysystem.Again,anysystemthatisusedmustensurethatthe electronic records are equivalent to paper records and theelectronic signatures are equivalent to traditional handwrittensignatures.

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The Food Safety Plan must be signed and dated by the owner,operatororagentinchargeofthefacility.ThismusttakeplacewhentheFoodSafetyPlan is initially completedand any time there is amodification.Thisensuresmanagementisinformedofchangesandindicatessupportofimplementation.

AllFoodSafetyPlanandimplementationrecordsmustincludebasicinformationtoprovideahistoryofwhathappened.Basicinformationincludes the name of the record; the name and, when necessary,locationofthefacility;thedate,andwhenappropriate,timethattheactivity was documented; and the actual measurements orobservations made, when applicable. For many records, productidentificationandalotcodemayberelevant,butforsomeprocesses,suchaspre‐operationalsanitationrecords,thetimeandthedateare

Examples of forms with all of this information follow.

A Food Safety Plan cover sheet that is signed and dated by the responsible individual is sufficient.

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adequate.Initialsorsignaturesofindividualsperformingmonitoringandverificationactivitiesarealsorequired.

Implementation Record Requirements and Examples

Food Safety Plan implementation records demonstrate that theactivities described in your plan were carried out. These includemonitoring,correctiveaction,severaltypesofverificationactivities,yoursupply‐chainprogramactivitiesandtrainingrecords.Examplesofsomeoftheserecordsarediscussedbelow.

Other implementation records may include information used forvalidation and decision making during hazard analysis, such aspublished scientific studies, in‐plant studies done by technicalexperts, and data from other experts such as trade associations,equipmentmanufacturersorsanitationchemicalproviders.

Documentationofverificationactivitiesassociatedwith thesupply‐chain program, such as ingredient testing, supplier audits, alsorepresentimplementationrecords.Thisincludeswrittenassurancesfrom customers that they control a hazard requiring a preventivecontrol,ifrelevanttoyourorganization.

Organizing these implementation records in a logical manner isrecommended to facilitate retrieval during inspection or when anincidentoccurs.

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Monitoringrecordscanberoutinelyusedbyanoperatorormanagertodetermine if aprocessorprocedure isapproachingaparameterandassociatedvalueorcriticallimitthatsuggeststhesituationisnotundercontrol.Thisenablestheoperatortomakeadjustmentsbeforeunacceptable results are observed. This adjustment can allow aprocess change before a deviation occurs, which can reduce oreliminate the labor and material costs associated with correctiveactions.

As previously mentioned, all monitoring information must berecorded at the time the observation is made. Accurate record‐keepingprovidesdocumentationthatfoodsafetyhazardsarebeingcontrolled. False or inaccurate records filled out before the actualoperationtakesplaceorthosethatarecompletedlatermayleadtoregulatoryandlegalactions,especiallyiffoundtobefraudulent.

Each monitoring record must be designed to capture themeasurementsorobservationsforparametersandassociatedvalues,such as critical limits, for the preventive control. The recordmusthave an identifier (e.g., a title or number) that corresponds to therecordwritten in theFoodSafetyPlan.Theactualmeasurementorobservationthatistakenmustalsoberecordedontherecord,alongwith the time (if appropriate) and date that the measurement orobservationwasmade,andthesignatureorinitialsofthepersonwhomade the observation.A signature or initials from thepersonwhoverified that the record complied with required parameters andassociatedvalues,aswellasthedateofthereviewisalsorequired.These verification procedures were discussed in Chapter 13:VerificationandValidationProcedures.

Because conditions in each facility are different, there is no singleformthatisappropriateforalloperations.Thefollowingmonitoring

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recordexamplesaregenericrecordsthatillustrateabasicdesignthatcanbeusedinafoodsafetypreventivecontrolsprogram.

This form documents the periodic monitoring of time andtemperatureundernormaloperatingconditionsofacooker.

This record is used to continuously monitor the operations of arefrigeratedstorageunit.Therecordisperiodicallycheckedvisuallybytheoperatortoensurecompliancewiththecriticallimit.Noticetheback of the chart is used to record the information requiredon allmonitoringrecords,suchasthenameand locationof thecompany,thenameoftheform,thedateandverificationreview.

Remember that the verification activity should include more than just signing the chart. Observation of trends by comparing different days is very useful for identifying issues BEFORE corrective action is required.

Example forms include a box for a verification reviewer signature. Either a signature or initials can be used for this purpose.

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This formdocumentstheuseof labels that identifyallergens intheproductortheproductingredients.Thefacilitycouldaffixonecopyofthecurrentlabelusedtothereport.Otherformatscanbeused.Themonitoring record could lookverydifferent for facilities thatuse adifferent approach to monitoring labels, for example if a barcodescannerwasused.

A corrective action record describes the deviation that triggeredcorrectiveactionandcapturesthefollowing:

x Product identification such as the product description, lotcodescoveredandamountofproductonhold,

x Summaryoftherootcauseofthedeviationandactionstakentopreventfurtheroccurrences,

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x Resultsoftheevaluationortestingofproductplacedonhold,ifnecessaryandthefinaldispositionoftheproduct,

x Name and signature of the person responsible for thecorrectiveaction(s),and

x Name and signature of the person reviewing the correctiveaction(s)report.

Asamplecorrectiveactionrecordisillustratedabove.Thisformcanalsobeused to recordcorrective actions forpreventive controls, ifrelevant.Keepinmindthatforsanitation,somecorrectionsmaynotrequirethe levelofdetailneededforprocessandallergencontrols.For example, if equipment is not clean prior to start up, then re‐cleaningtheequipmentistheappropriatecorrectiveactionwithnoimplicationsforproducthold.

The example above involved mislabeling of product in regard toallergen hazards. The information on the form describeswhen theincident occurred, what happened, what was done to correct thesituation, as well as what happened to the product. More specificinformationmaybeaddedinarealsituation.

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RecordsofverificationactivitiesmustbekepttodemonstratethattheFood Safety Plan has been implemented properly, monitoringmeasurementsorobservationsareaccurateandreliable,andthefoodsafety system is working as intended. Different records may beneededtocapturetheverificationinformationthatisspecifiedintheFoodSafetyPlan.

Examples of records with frequent verification activities mightinclude:

x Logsthatdocumenttheresultsofcheckstoverifytheaccuracyof thermometers, pH meters or other instruments used tomonitorcriticallimitsandotherparameters.

x Monitoring records by a trained individual under theoversight of a preventive controls qualified individual toverifythatparametersweremetandappropriatecorrectiveactionsweretaken.

Examplesoflessfrequent,butalsoimportantrecordsforverificationactivitiesmightinclude:

x Logs that document calibration activities for thethermometers,pHmetersandotherinstrumentsmentionedabove.

x Resultsofmicrobiological,chemicalorphysical testsofrawmaterials,in‐processproducts,finishedproductsortheplantenvironment

x Results of equipment evaluation tests, heat penetration ortemperature distribution for ovens, fryers or otherequipment.

x Auditrecordsverifyingsuppliercompliancewithfoodsafetyrequirements

Records generated by third parties must also meet the requirements for records. Examples on this slide may include validation studies, calibration records, product testing, and environmental monitoring when conducted by a consultant or outside lab.

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x Results from third party audits or regulatory agencyinspections

x ReanalysisactivitiessuchasareportdescribingmodificationsmadetotheFoodSafetyPlanbecauseofachangeinproducts,ingredients, formulations, processes, packaging ordistributionmethods

Asdiscussed inChapter13:VerificationandValidationProcedures,validation provides evidence that the parameters and preventivecontrols in the Food Safety Plan will control relevant hazards.Validationanswersquestionssuchas:Arewedoingwhatweshouldbedoing Arethepreventivecontrols(andtheparametersandvaluesor critical limits at CCPs) adequate to significantly minimize orprevent food safety concerns Is therenew information the facilityshouldconsiderregardingthesafetyoftheirproducts,likeemerginghazards Doeslackofcustomerorconsumercomplaints(whenyouhaveasystemtocollectthem)suggestthatthereishistoryofafoodsafetyconcern

Many sourcesof information canbeused tovalidate aFoodSafetyPlan.Theseincludevalidationstudiesdonebyprocessauthorities,in‐plantorchallengestudiesconductedonyourspecificproduct,tradeassociationsummariesonemerginghazards,universityorresearchinstitution reports and studies, peer reviewed journal articles, andregulatory or other guidance documents. Records supportingvalidationdecisionsmadebythefacilitymustbemaintained.

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This form could be used to document daily accuracy checks of allthermometersusedinthedailyprocessmonitoringoperations.Theformcouldbemodifiedtoincludeaprocedurenumberfortheworkinstructionsused.Otherwise,themethodorprocedurenumbercouldbe written in the Method column. Note that the thermometersensitivity should be based on thermometermanufacturer’s statedsensitivity.Anicebathwouldbeappropriatetocheckthermometersusedforcoldtemperatures.Ifboilingwaterisused,thetemperatureforthealtitudeatthelocationshouldbeindicated.Insteadofheadingthe column “BoilingWater Check” a standard operating procedurecouldbereferencedorotherdescriptiveterminology.

This form could be used to document the calibration check ofthermometers.Asmentionedintheverificationchapter, the facility

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needs to determine the frequency with which such activities areconducted.Thermometercalibrationmayoccuronaquarterlybasis,a monthly basis, an annual basis or other frequency deemedappropriateforthetypeofthermometerandotherconsiderations.

Chapter 13: Verification and Validation Procedures discussedprocedures forproduct testing forverification.Theresultsof thosetestsareverificationrecords.Data fromin‐houseoroutsidetestingshouldbemaintainedinoriginalrecordsthatdocument:

x thelaboratoryconductingthetest,x sampleidentification(includingdateofsampling,lotnumber,

etc.whereapplicable),x location of sampling (e.g., finished product, in‐process,

environmentalsamplesite,etc.),x dateoftest,x targetmicroorganismorchemical,x methodsusedandx resultsofthetestperunitvolume(e.g.,pergram,permilliliter

orperanalyticalunitforpresence/absencetests).

An example is not provided because the types of tests and theacceptablelimitsvarysubstantially.

NOTE: A result that says “Negative” or “Not detected” must also include the analytical unit (e.g., grams, milliliter, per swab, etc.) in order to determine the sensitivity of the test.

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Verificationorreviewofmonitoringandcorrectiveactionrecordsisanotherelementof record‐keeping.This reviewshouldensure thatthe information is complete and that procedures were followedappropriately.Aftertherecordisreviewed,itissignedanddatedbythe reviewer.The example aboveuses the corrective action recorddiscussedpreviously.F.S.Leader reviewed the informationenteredbythepackaginglinesupervisortoensurethatthedescriptionoftheincident was clear and that the corrective actions taken wereconsistent with those described in the allergen preventive controlchart.Verificationofmonitoringrecordsfollowsthesameprocess.

Asdiscussed inChapter13:VerificationandValidationProcedures,records of reanalysis of the Food Safety Plan are required whenunanticipateddeviationsoccur,whentherearerepetitivedeviations,

This form is not required but may be a useful starting point. Reanalysis must be documented as discussed in the verification chapter.

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atleasteverythree(3)yearsorifasignificantchangeinactivitiesornew information (e.g., FDA determination) creates a reasonablepotential for a new hazard requiring a preventive control or anincreaseinapreviouslyidentifiedhazard.Forexample,reanalysisisrequiredinasituationsuchasarecallwhenapreventivecontrolisfoundtobeineffectiveornotproperlyimplemented.Thisformcouldbeusedtodocumentthisreanalysis.Formsshouldbedevelopedtomeet the needs of the organization. While a flow diagram is notrequiredbyregulations, it isveryuseful to includeareviewduringreanalysisbecauseflowdiagramsprovideahighleveloverviewoftheprocess.Asummaryofchangesmadeisausefulaccompanimenttothischecklist.

Thisreportisanexampleofhowemployeetrainingactivitiescouldbedocumented.Othertrainingrecordscouldincludeattendancelistsortraining documents maintained in individual personnel files. Theapproachisflexible.

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Record Retention and Availability

ThePreventiveControlsforHumanFoodregulationrequiresthatfoodsafetyrelatedrecordsmustberetainedforaminimumof2yearsfromthedate the recordwas created.Records that relate to thegeneraladequacy of the equipment or processes being used, including thescientificstudiesandevaluations,mustbekeptat the facility foratleast2 years after their use isdiscontinued (e.g., because theFoodSafetyPlanhasbeenupdated).TheFoodSafetyPlanmustberetainedonsite. Electronic records are considered to be onsite if they areaccessible from onsite. Other records, such as monitoring records,maybe stored offsite if they are readily availablewithin 24 hours,when requested for official review (e.g., by FDA). All recordsassociatedwiththeFoodSafetyPlanareavailabletoFDAregulatorypersonnel,ortheirdesignate.

HavingorganizedandaccessiblerecordsisimportanttodemonstratethatyouhaveeffectivelyimplementedyourFoodSafetyPlan.

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Record‐keeping Summary

Records are an essential component of a food safety preventivecontrolssystem.Theyestablishthehistoryofpastactivityandcanbeused todemonstrate theeffectivenessofyour foodsafetyprogram.Thewritten Food Safety Plan and implementation records such asmonitoring records, corrective action records, verification recordsand applicable training records are required. Supply‐chainverificationactivitiesandassurancesarealsorequired.

Monitoringrecordsmustberecordedastheactivitytakesplace.Allrecords must be permanent (e.g., in ink with no erasures) andelectronicrecordscanbeusedif theymeetrequirements.Requiredrecordsmust be verified by an individual under the oversight of apreventive controls qualified individual. Upon request all recordsassociated with the Food Safety Plan must be made available forinspectionbyFDAortheirdesignee.

Additional Reading CanadianFoodInspectionAgency,2010.GuidetoFoodSafetyFDA.2003.GuidanceforIndustry:Part11,ElectronicRecords;ElectronicSignatures–

ScopeandApplicationFSPCAFoodSafetyPlanFormsGroceryManufacturer’sAssociation2013ASystemsApproachUsingPreventive

ControlsforSafeFoodProductionNationalConferenceonMilkShipmentworksheetsformilkplantuseNationalSeafoodHACCPAlliance2011.HazardAnalysisCriticalControlPoint–

TrainingCurriculum5thEditionNACMCFandCodexforms

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NOTES:

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CHAPTER 15. Recall Plan

The Preventive Controls for Human Food regulation requires thedevelopment of a written Recall Plan when a hazard analysisidentifies a hazard requiring a preventive control. This modulereviews definitions of recall classes, required elements of a RecallPlan, who to notify when a recall is necessary, how to conducteffectiveness checks and methods that can be used to dispose ofaffectedproduct.

Recalls are actions taken by an establishment to remove anadulterated, misbranded or violative product from the market. In

See Additional Reading for guidance on FDA’s mandatory recall authority.

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otherwords,aproductforwhichFDAorastatecouldtakelegalactionagainst the company would be subject to recall. If a companywithdrawsaproductthatdoesnotviolatefoodlawortheproducthasnot entered the marketplace, these situations dealing with qualityissues are not usually considered recalls butmay be considered astockrecoveryormarketwithdrawal.

Three classes of recalls are defined based on the potential healtheffects.

x AClassIrecallisthemostseriousandinvolvesproductthathasareasonableprobabilityofcausingseriousinjury,illnessordeath.

x Class II recalls may cause temporary illness that typicallyresolvesinfullrecovery.ForClassIIrecalls,deathandotherseriousconsequencesarenotlikely.

x ClassIIIrecallsarenot likelytocause illnessbutarestill inviolationofthelaw.

Typically,acompanyvoluntarilyconductsaproductrecall,eitherontheir own accord or at the request of FDA or a state. FDA has theauthoritytorequireacompanytoconductarecallinClassIsituations.

ARecallPlanmustbewrittenandinplacebeforeanadverseeventtakesplacetoensurethatactionstakentorecallafoodareconductedefficiently and as soon as possible. A rapid response is especiallyimportantforClassIandClassIIrecallsforwhichpublichealthisatrisk.

Thewritten Recall Planmust include procedures that describe thesteps to takeandassignresponsibility for takingthosesteps.Somepeople can be assigned tomultiple tasks, but their role should bepredeterminedtosupportaquickresponse.Therequiredproceduresinclude:

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1) direct customer notification, when required (see text box),about the food being recalled, including how to return ordisposeoftheaffectedproduct,

2) public notification about anyhazardpresentedby the food,whenappropriatetoprotectpublichealth,

3) effectivenesscheckstoverifythattherecallwascarriedout,and

4) appropriate disposition of the food through reprocessing,reworking,diverting toause thatdoesnotpresentasafetyconcernordestroyingthefood.

ThePreventiveControlsforHumanFoodregulationdoesnotspecifyhow a facility should carry out the procedures discussed above.Commonindustrypracticesinclude:

x predefinedrolesandresponsibilities;x procedurestodetermineifarecallisneeded;x contactlistsforexternalnotificationofregulators,customers,

andthepublic;x lotidentificationdescriptions;x effectivenesscheckprocedurestobeusedduringarecall;x formstorecordinformation;andx draftnoticestocompleteintheeventofarecall.

Abriefdiscussionoftheseelementsfollows.

Notification of customers is required for Class 1 recalls and sometimes for Class 2 recalls when there is a threat to public health. Decisions on when notification is necessary can be determined through discussions with FDA. FDA has the authority to initiate a recall in class I situations, but typically a company voluntarily issues the recall notice.

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Theowner,operatororagentinchargeofafacilityisaccountableforthesafetyofthefoodandmustensurethataRecallPlaniswritten.Arecall coordinator and recall team are typically identified ahead oftime.Therecallcoordinatorgenerallyhasthefollowingduties:

x Directsallproductrecallsx Directs the recall team and coordinates all actions and

communicationsduringaproductrecallscenariox Ensures that all appropriate documentation relating to the

manufacture and shipment of the affected product iscollected;e.g.,processingrecords,laboratorytestingrecords,ingredientbatchsheets,inventoryreports,shippingmanifestsetc.dependingontheincident.

x Determines (e.g., from inventorymanagement and shippingrecords) exact location and quantity of affected productinvolvedintherecall

x Reportsthestatus,findingsandrecommendationsrelatedtoallproductrecallsituationstoseniormanagementiftheyarenotpartoftherecallteam

x Notifiesallpertinentregulatoryagenciesx Maintainstheestablishment’swrittenpolicy,RecallPlanand

allassociatedrecallactivitiesThe recall team should include all functions necessary to collectaccurate and complete information. For example, production,shipping, quality assurance, sales and administrative personnelshouldbeconsideredasmembersoftherecallteam.Ifthefirmhasmultiple locations, the teammay include corporate teammembersfrom different departments (e.g., safety, quality assurance,

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distribution, etc.). Each recall team member should have clearlydefinedroles.

The Recall Plan should define each step of the recall process andclearlydescribewhatneeds tobedoneandwho is responsible forcarrying out the task. Knowing this ahead of time and practicingreducesconfusionandhelps tosupportanorganizedresponse. Jobresponsibility(whoisresponsible)shouldbeclearlydefinedforwhowillinitiatetherecallandwhowillnotifyexternalcustomers.

Cleardocumentationhelps todefine the extent of the recall.Whileseveral people may be involved in gathering different types ofdocuments,compilingtheinformationanddatagatheredultimatelyshouldbedonebyoneindividualtoensurethatacompletepictureofthesituationisavailable.Assignresponsibilityforeachofthetypesofdocumentsneededtoensurethateverythingiscompleted.

Whenrecallsoccur,frequentlysomeoftheaffectedproductisstillinthe company’s control and some of the product is in the hands ofcustomers or in route. In addition to notifying customers, assignresponsibility and define procedures for securing inventory that isstill within your control to avoid increasing the problem byinadvertentlyshippingproductthatwouldbesubjecttorecall.

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Whenitisdeterminedthatarecallisnecessary,notifytheappropriateregulatoryagencies.InadditiontoFDAcontacts(seetextbox),manystates have recall coordinators. It is useful to include their contactinformationinyourRecallPlan.Insomecases,anagencymaynotifyyou first, for example if a foodborne illness is traced back to yourproduct.Inothercases,youmayneedtoinitiatethecontact,suchasif you receive several calls from consumers regarding an allergicreactiontoyourproductandyoudeterminethattheproducthasanallergenthatwasnotlistedonthelabel.

TheRecallPlanmust includeprocedures fornotificationofoutsidecustomers/consigneeswhoreceivedproduct. oushouldinformyourcustomersofthetypeofproduct,quantitiesofaffectedproducttheyreceived,datesproductwasshippedandreasonfortherecall.Alsotellcustomerstoimmediatelyputproductonhold.Onceinformationisgathered, product disposition will be determined, as well aseffectivenessoftherecalleffort.

Apressreleaseisusuallyusedtoinformthepublicofarecallthathasa public health issue. While a detailed press release cannot bedevelopeduntilanincidentoccurs,aRecallPlancanincludetemplatesthat describe the information that would be inserted and shouldidentifywheretosendapressreleaseifthisisnecessary.FDAmustapprove the press release and has model press release examplesavailable(seeAdditionalReading).

Useful FDA Websites

The Reportable Food Registry (RFR) is an electronic portal for industry to report when there is reasonable probability that a food will cause serious adverse health consequences. You must report issues that you find. The RFR is also useful for investigating information on foods that have been reported.

FDA posts recall notices on their website. Model recall notices are also available, which you could use to create a draft recall notice for your Recall Plan.

FDA provides contact information for recall coordinators on the web. Include this information in your Recall Plan and consider getting to know them prior to a recall situation. For example, several states have Food Safety Task Force meetings that provide access to regulatory officials in an open forum.

See Additional Reading

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Lots involved in a recallmust be accurately identified.How this isdoneisdictatedbyhowmaterialsaretrackedfromincominggoodsthroughtheprocessandindistribution,aswellashowalotisdefined.Recalleffortsinvolveidentifyingspecificlotsthatmightbeimplicatedand then tracing thoseproducts through thedistributionsystemtoensure that all product that has not already been consumed isrecovered.

Specific information on how lots are identified should be easilyunderstood by all the stakeholders that receive this informationduringarecallinvestigation.Unclearorpoorlyidentifiedlotshampertheeffectivenessofanyrecalleffortandincreasetheamountoftimeand resources needed to complete the recall. It is critical that lotrecords are clearly identified and stored so that they are rapidlyaccessibleintheeventofarecall.Besuretoconsiderhowreworkisused in a facility – if rework from an implicated batch is used insubsequentbatches, theamountofproduct involved inarecallcanexpandbeyondtheimplicatedbatch.

Allinformationshouldbecrosscheckedagainstmultiplesourcesandthroughmultiplepeoplesothattheaccuracycanbeverifiedpriortoinitiationof therecall. Incompleteorerroneous informationcausesconfusionanddelaysintransmittinginformationthatisneededbytherecoveryteam.Itcannotbeoveremphasizedthatcorrectinformation,basedonaccuraterecords,isacriticalrequirementforefficientrecallactivities.Governmentagencieswillreviewtheserecordsandlackoforganizationcanslowdowntheprocess.

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The recalling establishment must determine whether its recall isprogressing satisfactorily. The firm has an obligation to conducteffectiveness checks as part of its recall process. These checks areusedtoverifythatallaffectedconsigneeswerenotifiedaboutarecallandhavetakenappropriateaction. ourRecallPlanshoulddescribehow you will conduct effectiveness checks during a recall. Mostestablishments follow up daily with consignees via phone calls oremailtoensuretheyareprogressingin locatingandsegregatingallaffectedmaterial.Insomecasesonsiteassistancemaybenecessaryatconsignee locations. See the example at the end of the chapter forideasonhowthismightbestructured.

TheRecallPlanmustincludeproceduresthatdescribethestepstakento determine the appropriate disposition of the recalled product.

It may be possible to divert product for animal food use. See the discussion on GMPs for animal food use and the Preventive Controls for Animal Food regulation for more information.

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Dependinguponthehazardandthefood,sometimesaproductcanbereconditioned or reworked to eliminate the hazard. Diverting theproducttoanotheruse,suchasanimalfoodproduction,mayalsobean option if it does not present a safety concern. As discussed inChapter 3: GMPs and Other Prerequisite Programs, if you plan todiverttheproducttoanimalfooduse,thefoodmustcomplywiththePreventiveControls forAnimalFood regulation – plan ahead if youwanttoconsiderthisoption.Destructionofthefoodisthefinaloptionandissometimenecessary.

Procedures for product disposition need to consider both productthatisin‐house(andthusundertheestablishment’scontrol),aswellasproductthatisreturnedfromcustomers.Insomecases,youmayhave customers destroy product instead of returning it. Suchsituations could be described in your plan. In any case, a clearaccounting of the amount of product available and its ultimatedispositionisneededtocloseoutarecall.

When a food safety recall occurs, reanalysis (see Chapter 13:Verification and Validation Procedures) of the Food Safety Plan isrequiredtodeterminehowtopreventarecurringsituation.Insomecases, modification of the Food Safety Plan may be required. Forexample,ifanewhazardisidentified,thenthehazardanalysisshouldbeupdatedtoincludethathazardandpreventivecontrolsshouldbemodifiedoraddedtoensureongoingcontrol.Inothercases,theFoodSafety Planmay be adequate, but implementation of the planmayneedtobeimprovedthroughenhancedtraining,equipmentupgradesorotherrelevantcorrections.Inanycase,thefoodsafetyteamshouldstrivetodeterminetherootcauseoftheproblemandactquicklytotakecorrectiveactions,asappropriate.

Refer to previous chapters on process, allergen and sanitationpreventivecontrols,aswellasonsupply‐chainprogramsandrecord‐

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keeping for information on corrective action documentationrequirements.Keepalogofalldecisionsmadethroughouttherecalland maintain this as part of your recall records. This includes asummaryofactionstakenatthefinalrecallreviewmeeting.

ThereferencesandresourcesattheendofthischapterandinChapter7:ResourcesforFoodSafetyPlansprovideexamplesandtemplatesthatcanbeusedtoconstructaRecallPlanandassociatedrecordstosupporttheseefforts. ouwillalsofindanexampleRecallPlanattheend of this chapter and a template that provides forms andconsiderations to help you develop a Recall Plan specific to youroperation.

Oncetherecallplanisdeveloped,itisimportanttoperiodicallytestthesystemtoensurethatitwillworkifarecallisnecessary.Thisissometimesreferredtoa “mockrecall.”Thesemockrecalls typicallyincludeverifyingthattheinformationintherecallplaniscurrent,andtestingtherecallteamtodetermineiftheycandowhatneedstobedoneiftherewasarecall.Tracingproductsandingredientsone‐stepforwardandone‐stepbackinthesupplychainisacommonelementof amock recall, however, actual customers and suppliers are nottypicallycontactedtoavoidconfusion.

Traceability checks are an important part of a mock recall. Thesechecksdeterminehow long it takes identifywhere a specific lot ofproductwassent(onestepforward)andtoidentifythesourceandlotcode(s)ofallingredientsusedintheproductionlot(onestepback).In addition, it is useful to test the recall team to see if they candetermineifarecallisactuallynecessary,iftheyknowwhoandhowtocontactfortechnicalhelpifneeded,iftheycancreatetherequireddocumentationtoperformarecall.

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Atestofthesystemcanbeperformedovertime(e.g.,verifyingcontactinformation),butthe importanceofconductingtrialsshouldnotbeoverlooked.Beingpreparedcansametime,moneyandlives.

Recall Plan Summary

A Recall Plan is requiredwhen hazard analysis identifies a hazardrequiringapreventivecontrol,anditisagoodideatohaveoneevenifyoudonotidentifysuchahazard.ApredefinedfoodsafetyRecallPlanenablesrapidresponse toremovecontaminatedproduct fromthemarketplaceifitcontainsahazardthatcancauseillnessorinjury.ourRecallPlanshoulddefinewhotocontactifarecallisnecessarytominimize the impact of the recall on public health and on yourbusiness. Effectiveness checks are required when a recall occurs.Mock recalls are useful to ensure that the plan is current and thatpeople understand their roles. A rapid and efficient response canreducethenumberof illnessesandprotectyourbusiness.FDAandotherregulatoryauthorizeslikestateofficialswillworkwithyouonproperdispositionoftheproduct.

Additional Reading Arecallplantemplatefollowstheadditionalreadinglist.Thiscanbeusedtodevelopyourownrecallplan.ThetemplateisavailableontheFSPCAwebsite.Otherreferencesproviderecallplanexamples,templatesoradditionalinformation.

AssociationofFoodandDrugOfficials(AFDO)Directoryofstateandlocalofficials(DSLO)–adirectoryofregulatoryofficialsinvolvedwithfood,animalfeed,animalhealth,andfooddefense.

FDA2012.GuidanceforIndustry:ProductRecalls,IncludingRemovalsandCorrections.

FDA2013.Chapter7RecallProcedures,inRegulatoryProceduresManualFDA2013.MonitoringandAuditingRecallEffectiveness.FDA2014.ORADistrictandHeadquartersRecallCoordinators.FDA2014.ReportableFoodRegistry(RFR)AtaGlance

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GroceryManufacturersAssociation2008.FoodSupplyChainHandbook.InstituteofFoodTechnologists.2015.GlobalFoodTraceabilityCenter,Resource

LibraryUniversityofFlorida,IFASExtension.2008.TheFoodRecallManual

NOTES:

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Recall Plan Template and Teaching Example

CompanyName RecallPlan

Reviewedby:Signature,Title Date:September14,2015

ThismodelRecallPlanidentifiesinformationthatiseitherrequiredorrecommendedtofacilitateaneffectiveandefficientrecall.WhileaRecallPlanisrequiredbythePreventiveControlsforHumanFoodregulation,nospecificformatandcontentisspecified.ThismodelcontainsquestionsandtemplatesthatcanbeusedtodevelopanindividualizedRecallPlan.ARecallPlanmustbedevelopedaspartofyourFoodSafetyPlanrecords.

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Table of Contents Recall Team ................................................................................................................................ 15Determining if a Recall Action Necessary ................................................................................... 16Information Templates for FDA Communication ......................................................................... 17

PRODUCT INFORMATION: ................................................................................................... 17CODES (Lot Identification Numbers): ..................................................................................... 17RECALLING FIRM Contacts ................................................................................................... 18

REASON FOR THE RECALL: .................................................................................................... 19VOLUME OF RECALLED PRODUCT: ................................................................................... 20DISTRIBUTION PATTERN: .................................................................................................... 20

CONSIGNEE LIST ...................................................................................................................... 21RECALL STRATEGY: ................................................................................................................. 22

Level in the distribution chain .................................................................................................. 22Instructions for Consignee Notification .................................................................................... 22Effectiveness Checks .............................................................................................................. 22Product destruction/ reconditioning ......................................................................................... 23

DRAFT Recall Notice .................................................................................................................. 24

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Recall Team [Add, combine or delete rows to accommodate your operation] Assignment Person ContactInformation

SeniorOperationsManager

Alternate:

Office:xxx‐xxx‐xxxxMobile:xxx‐xxx‐xxxxHome:xxx‐xxx‐xxxx

PublicityandPublicRelations

Alternate:


Sales&Marketing

Alternate:


ScientificAdvisor

Alternate:


LogisticsandReceiving

Alternate:


ualityAssurance

Alternate:


Accountant

Alternate:


Attorney

Alternate:


AdministrativeSupport Office:xxx‐xxx‐xxxxMobile:xxx‐xxx‐xxxxHome:xxx‐xxx‐xxxx

FDARecallCoordinator Office:xxx‐xxx‐xxxx

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Determining if a Recall Action Necessary

Problemreportedby

InitialAction Decisions Actions

RegulatoryAgencybelieveyourproductiscausingillness

Assemblerecallteamandaskagencyifrecallisrecommended

Evaluatesituation;decideif,whatandhowmuchproductto

recall

Ifnorecallisneeded:

Documentwhynotandaction.

Newsmediastoryonproblemwithatypeoffoodyouproduce

Assemblerecallteam,reviewinternalrecords

Ifrecallisneeded:

x Assignresponsibilities

x Gatherevidence

x Analyzeevidence

x Getwordout

x Monitorrecall

x Disposeofproduct

x Applyforterminationofrecall

x Assemblerecallteamanddebrief

x Prepareforlegalissues

Internal Corcustomerinformationsuggestapotentialproblem

Assemblerecallteamandreviewinternalrecords

HealthDepartmentbelievesyourproduceiscausingillness

Assemblerecallteam,contactappropriateregulatoryagency

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Information Templates for FDA Communication

PRODUCT INFORMATION: Modifythe“ProductDescription,Distribution,ConsumersandIntendedUse”formasneededtoreflectonlytheproductinvolved,including:

x Productname(includingbrandnameandgenericname)x Productnumber/UPCorproductidentificationx Removeanynamesofproductsthatarenotinvolvedintherecall

AssembleTWOCOMPLETESETSOFALLlabelingtotheLocalFDADistrictRecallCoordinator.Include:

x Productlabeling(includingALLprivatelabels)x Individualpackagelabelx Caselabel(photocopyacceptable)x PackageInsertsx DirectionsforUsex PromotionalMaterial(ifapplicable)

CODES (Lot Identification Numbers): x UPCcode(s)involved:

x Lotnumber(s)involved:

x Lotnumberscodingsystem:Describehowtoreadyourproductcode:‐______________________________________________________________________

_____________________________________________________________________

x Expectedshelflifeofproduct:

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RECALLING FIRM Contacts ProvidethisinformationtoFDAforclearcommunication:

Manufacturername: Nameandaddress

Position Name,Title ContactInformation

RECALLcoordinator Office:xxx‐xxx‐xxxxMobile:xxx‐xxx‐xxxFax:xxx‐xxx‐xxxxemail:xxxxxxxxxx

Mostresponsibleindividual

Office:xxx‐xxx‐xxxxMobile:xxx‐xxx‐xxxFax:xxx‐xxx‐xxxxemail:xxxxxxxxxx

Publiccontact:

Maybeoneoftheaboveoranotherindividual.Ifpossible,itisusefultonameadifferentindividualtoallowthecoordinatorfocusonretrievingproductandresolvingtheissue

Office:xxx‐xxx‐xxxxMobile:xxx‐xxx‐xxxFax:xxx‐xxx‐xxxxemail:xxxxxxxxxx

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REASON FOR THE RECALL: Explainindetailhowproductisdefectiveorviolative

Explainhowthedefectaffectstheperformanceandsafetyoftheproduct,includinganassessmentofahealthriskassociatedwiththedeficiency,ifany.

Iftherecallisduetothepresenceofaforeignobject,describetheforeignobjects size,composition,hardness,andsharpness.

Iftherecallisduetothepresenceofacontaminant(cleaningfluid,machineoil,paintvapors),explainlevelofcontaminantintheproduct.Providelabeling,alistofingredientsandtheMaterialSafetyDataSheetforthecontaminant.

Iftherecallisduetofailureoftheproducttomeetproductspecifications,providethespecificationsandreportalltestresults.Includecopiesofanysampleanalysis.

Iftherecallisduetoalabel/ingredientissue,provideandidentifythecorrectandincorrectlabel(s),description(s),andformulation(s).

Explainhowtheproblemoccurredandthedate(s)itoccurred.

Explainiftheproblem/defectaffectsALLunitssubjecttorecall,orjustaportionoftheunitsinthelotssubjecttorecall.

Explainwhythisproblemaffectsonlythoseproducts/lotssubjecttorecall.

Providedetailedinformationoncomplaintsassociatedwiththeproduct/problem:

x Dateofcomplaintx Descriptionofcomplaint‐include

detailsofanyinjuryorillnessx LotNumberinvolved

IfaStateagencyisinvolvedinthisrecall,identifyAgencyandcontact.

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VOLUME OF RECALLED PRODUCT: Totalquantityproduced

Date(s)produced

uantitydistributed

Date(s)distributed

uantityonHOLD

Indicatehowtheproductisbeingquarantined

Estimateamountremaininginmarketplacex distributorlevel

x customerlevel

Providethestatus/dispositionofmarketedproduct,ifknown,(e.g.used,usedinfurthermanufacturing,ordestroyed).

DISTRIBUTION PATTERN: NumberofDIRECTaccounts(customersyouselldirectlyto)bytype

Type Number

� wholesalers/distributors

� repackers

� manufacturers

� retail

� consumers(internetorcatalogsales)

� federalgovernmentconsignees

� foreignconsignees(specifywhethertheyarewholesaledistributors,retailersorusers)

� Geographicareasofdistribution,includingforeigncountries

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CONSIGNEE LIST ProvidethislisttothelocalDistrictRecallCoordinator.IncludeUScustomers,foreigncustomersandfederalgovernmentconsignees(e.g.,USDA,VeteransAffairs,DepartmentofDefense)

Commercialcustomers

Name StreetAddress

City State Recallcontactname

Contactphonenumber

Recalledproductwasshipped?

Recalledproductwassold?

Recalledproductmayhavebeenshippedorsold

WasproductsoldunderGovernmentContract?

Yes______No______

Ifyes,includecontactnameandinformationaboveANDcompleteinformationbelow.

ContractingAgency ContractNumber Contractdate Implementationdate

SchoolLunchProgram:

Ifproductwassoldtofederal,stateorlocalagencyfortheschoollunchprogram,completetableandnotify“shipto”(sotheycanretrieveproduct)and“billto”customers(sotheycaninitiatethesub‐recall).

Consignee Quantity Saledate Shipmentdate

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RECALL STRATEGY:

Level in the distribution chain

Level Included Rationaleif“No”es NoWholesale/distributor

Retail

Instructions for Consignee Notification Writeinstructionsonhowconsigneeswillbenotified(i.e.bymail,phone,facsimile,e‐mail).NOTE:Itisadvisabletoincludeawrittennotificationsocustomerswillhavearecordoftherecallandyourinstructions.Includeinstructionssuchas:

x Howletterswillbesenttocustomers(e.g.overnightmail,firstclassmail,certifiedmail,facsimile)

x Draftphonescript,ifyoudecidetousephone.NOTE:Ifinitialnotificationisbyphone,bepreparedtoprovideacopyofthephonescripttoFDA.

x Draftrecallnotification(seeexampleonlastpage)forwebsiteandinstructionsforpostingit,ifapplicable.NOTE:Thewebisnotrecommendedasasolemeansofcustomernotification.

x Draftinstructionsforconsigneesonwhattodowithrecalledproduct.Ifthereisarecall,FDAwillwantacopyoffinalinstructions.

x Considerwhattodoforout‐of‐businessdistributors.

Effectiveness Checks Effectivenesschecksbyaccount–ConsiderfillingintheConsignee’srecallcontactnameandinformationtomakeiteasiertocontactthemintheeventofarecall.

Consignee Recallcontact Datecontacted

Methodofcontact Dateifresponse

Numberofproductsreturnedorcorrected

Name Contactinfo

Phone Email Fax Letter

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Effectivenesschecksummary–tobeprovidedtoFDAperiodically

Dateofnotification

Methodofnotification

Numberofconsigneesnotified

Numberofconsigneesresponding

uantityofproductonhandwhennotificationreceived

Numberofconsigneesnotrespondingandactiontaken

uantityaccountedfor

Estimatedcompletiondate

Product destruction/ reconditioning o Provideaproposedmethodofdestruction,ifapplicable.o Iftheproductistobe reconditioned ,explainhowandwherethereconditioningwilltakeplace.

ItisrecommendedthatyouprovidedetailsofthereconditioningplantoyourlocalFDADistrictRecallCoordinatorbeforeimplementation.AllreconditioningmustbeconductedunderanyapplicableGMPs.

o Describehowreconditionedproductwillbeidentifiedsoitisnotconfusedwithrecalled(pre‐reconditioned)product.

o ItisrecommendedthatyoucontactyourlocalFDADistrictRecallCoordinatorpriortoproductdestruction.FDAwillreviewyourproposedmethodofdestructionandmaychoosetowitnessthedestruction.

o ouandyourcustomersshouldkeepadequatedocumentationofproductdestruction(andwhetherornotdestructionwaswitnessedbyanFDAinvestigator).

o Fieldcorrections,likeproductrelabeling,beperformedbyrecallingfirmrepresentatives,orundertheirsupervisionandcontrol.ContactyourlocalFDADistrictRecallCoordinatorpriortoreleaseofreconditionedgoods.

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DRAFT Recall Notice

[CompanyName]VoluntarilyRecalls[insertsummaryinfo]Representing[Xquantity][‐‐NoOtherProductsAffected‐‐]

Contact Consumer: 1‐xxx‐xxx‐xxx Media Contact: xxx‐xxx‐xxxx

FOR IMMEDIATE RELEASE – [date] – [Company name] is voluntarily recalling [X] Lot Codes of [COMPANY/BRAND name] [insert specific product name and description], representing [insert quantity]. [Insert reason for recall].

This action relates only to [COMPANY NAME] products with any of these Lot Codes printed on the package:

x [insert lot codes]

No other Lot Codes, or any other [COMPANY NAME] products, are involved in this action.

Only these specific lot codes are impacted. Customers are asked to remove all product with codes listed below out of distribution immediately. Customers may call the number listed or visit our website for instructions on what to do with the product.

PRODUCT LOT CODE ITEM NO.

[Company Name] [insert product name(s)] [insert product codes(s)] [insert item number(s)]

[Company Name] is conducting this voluntary recall because [insert product name(s)] [modify as necessary. We have not received any reports of illness associated with this product, but we are voluntarily recalling this product out of an abundance of caution.]

For more information or assistance, please contact us at 1‐xxx‐xxx‐xxxx (Monday to Friday, 9:30 a.m. to 5 p.m. EST) or via our website at www.xxx.com

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CHAPTER 16. Regulation Overview – cGMP, Hazard Analysis, and Risk‐based Preventive Controls for Human Food

On September 17, 2015, FDA’s final regulation on Current GoodManufacturing Practice,Hazard Analysis, and Risk‐based PreventiveControlsforHumanFoodwaspublished.Theregulationfocusesonapreventive approach to food safety and is knownas thePreventiveControlsforHumanFoodregulation.Werefertoitas“theregulation”fortherestofthischapter.AcopyoftheentiretextoftheregulationisfoundinAppendix1ofthismanual.

This course was developed to assist food establishments withdeveloping and implementing risk‐based preventive controls thatcomply with the regulation. In some sections of the course, theinformationprovidedgoesbeyondwhatisintheregulationtoassistwith implementation of a robust Food Safety Plan. This modulefocusesonthespecificrequirementsoftheregulation.Itcontainsthespecific provisions and regulatory citations for the regulatoryrequirements. This is an overview of the regulation. If you havespecificquestionsoninterpretation,youcanusetheFSMATechnicalAssistanceNetwork(seeTextBox)orlegalcounsel.

You can submit questions about this regulation to FDA’s FSMA Technical Assistance Network using a web form at http://www.fda.gov/FSMA.

This form provides FSMA Technical Assistance Network subject matter experts with the information needed to give accurate and timely responses.

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TheregulationisPart117inTitle21oftheCodeofFederalRegulationsandcontainssevensubparts:

A. generalprovisionssuchasdefinitionsandexemptions;B. currentGoodManufacturingPracticerequirements;C. hazardanalysisandrisk‐basedpreventivecontrols,whichis

themainfocusforthiscourse;D. modifiedrequirementsforcertainfacilities;E. withdrawalofaqualifiedfacilityexemption;F. requirements for records that must be established and

maintained;andG. requirementsforasupply‐chainprogram.

Subpart A – General Provisions

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Subpart A discusses applicability of the regulation to differentfacilities; defines terms used in the regulation; addressesqualificationsforindividualswhomanufacture,process,packorholdfood; and identifies exemptions from specific regulatoryrequirements for certain situations. It also updates definitions inotherpartsoftheCodeofFederalRegulationssuchasclarifyingwhatconstituteson‐farmmanufacturing,packingandholdingoffoodin21CFRPart1.Italsodefinesasmallandverysmallbusiness,whichhavedifferentcompliancedates.TheseupdateswererequiredbytheFoodSafetyModernizationAct’ssection103.

Facilitiescoveredbythepreventivecontrolsrequirementsin21CFR117arethosethatmanufacture,process,packorholdhumanfood.Ingeneral, facilities required to register with FDA under currentregulations are covered. This applies to both domestic and foreignfood processors exporting food covered by 21 CFR 117 to theU.S.Farmsandretailfoodestablishmentsarenotcovered.Therearesomeexemptionsandmodifiedrequirements,whicharecoveredlater.

Facilities can register on FDA’s website.

The National Sustainable Agriculture Coalition has information designed to help farmers, small food businesses, and the organizations that work with them understand whether the FSMA rules apply to them and, if so, what requirements apply. Look for “Who is Affected” page on their website. http://sustainableagriculture.net/fsma/who‐is‐affected/

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Theregulationrequiresthatallindividualsthatmanufacture,process,pack or hold foodmust have the education, training or experiencenecessarytoperformtheirjobsinamannertokeepthefoodcleanandsafe. Individuals need specific training in the principles of foodhygieneand foodsafety asappropriate to the individual’s assignedduties. The level of training varies based on duties. For example,training fora fork liftoperatormayvary fromthat foranoperatorhandlingunpackagedready‐to‐eatfood.Supervisorsmustalsohavethe education, training or experience necessary to supervise theproductionofcleanandsafefood.Recordsmustbemaintainedforthefoodhygieneandfoodsafetytraining.

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Most exemptions arewith respect to the hazard analysis and risk‐based preventive controls provisions. The first example of anexemptionisfor“qualifiedfacilities,”whichinclude:

x Very small businesses (less than 1million in total annualsales of human food plus the value of food manufactured,processed,packedorheldwithoutsale(e.g.,forafee))or

x Foodsalesaveraginglessthan 500,000peryearduringthelastthreeyearsandsalestoqualifiedend‐usersmustexceedsalestoothers.

“ ualifiedend‐users”areconsumersinanylocation,andrestaurantsand retail food establishments in the same state (or Indianreservation)orwithin275milesofthefacilitythatpurchasethefoodfor sale directly to consumers. ualified facilities are exempt fromhazard analysis and preventive controls requirements (includingsupply‐chainprograms)butcertaindocumentationisrequired.TheyarestillsubjecttotheGMPregulations.

Theregulationprovidesanexemptionforthefollowing:

x FoodsubjecttoHACCP(seafoodandjuice‐117.5(b)andc))x Foodsubjecttolow‐acidcannedfoodregulations(onlywith

respecttomicrobiologicalhazards)(117.5(d))x Dietarysupplements(117.5(e))x Foodsubjecttoproducesafetyrequirements(117.5(f))x Alcoholicbeverages(117.5(i))

The types of businesses listed are exempt from Food Safety Planrequirements provided that (with the exception of alcoholicbeverages) they are in compliance with the applicable regulationsreferenced above. These businesses are not exempt from GMPrequirements and low‐acid canned foods manufacturers must

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conduct a hazard analysis to determine if chemical and physicalhazardsareanissue,anddocumenttheanalysis.

Facilities such as warehouses that store only unexposed packagedfoodareexemptfromtherequirementsforhazardanalysisandrisk‐based preventive controls, with one exception. That is, certainpackagedfoodforwhichrefrigerationisrequiredforsafetymusthavetemperaturecontrols,monitoring,verificationandrecords.

Certainstoragefacilitiessuchasgrainelevatorsandwarehousesthatonly store raw agricultural commodities (other than fruits andvegetables) intended for further distribution or processing areexemptfromhazardanalysisandrisk‐basedpreventivecontrols.

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FSMAprovidedFDAwithauthoritytoexemptormodifyrequirementsfor storage of raw agricultural commodities (RACs) intended forfurtherdistributionorprocessing,butspecificallyexcludedstorageoffruitsandvegetables.

21CFR117SubpartB(GMPs)doesnotapplytofarmsandactivitiesof farmmixed‐type facilities, fishing vessels, establishments solelyengagedinholdingortransportationofrawagriculturalcommodities,and establishments solely engaged in hulling, shelling, drying,packing, and/orholdingnutswithoutadditionalprocessing.This isbasedonanexistingprovisionintheGMPs(21CFR110.1 (a))knownasthe“RACexemption.”

GMPsapply topackaging,packingandholdingofcertaindriedrawagricultural commodities such as raisins made from grapes.Compliance may be achieved by complying with Subpart B or theapplicable requirements for packing and holding in part 112.Similarly,off‐farmpackaging,packingandholdingofrawagriculturalcommodities are subject to the GMPs; if these commodities areproduce(asdefinedin21CFRpart112)compliancemaybeachievedby complying with Subpart B or the applicable requirements forpackingandholdinginpart112.

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Farm‐relatedexemptionsareactivitieswithinthedefinitionof“farm”in 21 CFR 1.227, including farm activities that are covered by theproduceregulation,andcertainlow‐riskmanufacturing/processingactivities conducted by small/very small businesses on farms forspecific foods. The regulation includes an exhaustive list and theexemptiononlyapplies if theseare theonlyactivities theyconductthatweresubjecttotheregistrationrequirement.

Subpart B – Current Good Manufacturing Practice

UpdatedGMPsarepartoftheregulation(movedfrom21CFR110to21CFR117).Requirementsforpersonnel,plantandgrounds,sanitaryoperations, sanitary facilities and controls, equipment andutensils,processes and controls, warehousing and distribution, and defectactionlevelsareaddressedunderGMPprovisions.Inaddition,anew

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provisionwasaddedforholdinganddistributionofhumanfoodby‐productsforuseasanimalfood.GMPprovisionsarenotthefocusofthiscourseonhazardanalysisandpreventivecontrols,butanupdatefollows.

TheGMPsweremodifiedtoclarifythatcertainprovisionsrequiringprotection against contamination of food also require protectionagainstallergencross‐contact.Further,languageintheregulationwasupdated, such as using “must” instead of “shall,” and“manufacturing/processing” in place of “manufacturing” forconsistency with definitions. Certain provisions containingrecommendationsweredeletedandmaybeaddedtoguidance(e.g.,previousprovisionsusing“should”or“compliancemaybeachievedby”).

The GMP regulations now require cleaning of non‐food‐contactsurfacesasfrequentlyasnecessarytoprotectagainstcontaminationof food and food‐contact surfaces. Additionally, the holding anddistributionofhumanfoodby‐productsforuseasanimalfoodisnotsubject to thePreventiveControls forAnimalFood regulation if thehumanfoodfacilitycomplieswiththehumanfoodGMPsanddoesnotfurther manufacture the by‐products. Facilities that hold anddistribute human food by‐products for use as animal food mustcomplywith21CFR117. 5.

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Subpart C – Preventive Controls

Thefocusofthistrainingprogramison21CFR117SubpartC:HazardAnalysisandRisk‐basedPreventiveControlsforHumanFood(referredto as “Preventive Controls for Human Food regulation” in thisdocument) and Subpart G: Supply‐Chain Program. Each facility isrequired to implement a written Food Safety Plan that focuses onpreventinghazardsinfoods(21CFR117.126).

Theregulationfocusesonidentifyinghazardsrequiringapreventivecontrol, thusawrittenhazardanalysis isrequired.The firstpartofhazard analysis is identification of biological, chemical (includingradiological) andphysical hazards thatmaybe associatedwith thefacility or the food. These hazards may occur naturally, may be

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unintentionally introduced or may be intentionally introduced foreconomicgain.

Examplesofbiologicalhazardsincludepathogenicbacteria(includingenvironmental pathogens), viruses, parasites and other pathogens.Chemicalhazardexamples include radiologicalhazards, substancessuch as pesticide and drug residues, natural toxins, certaindecomposition products, unapproved food or color additives, andfood allergens. Physical hazards examples include stones, glass ormetal fragments that could inadvertently be introduced into food.Hazardsintroducedforeconomicgainmustalsobeconsidered.

During the hazard analysis process, the hazard evaluation isconductedtodeterminethehazardsrequiringapreventivecontrol.Thisevaluationincludesanassessmentoftheseverityoftheillnessorinjury that would result if the hazard was in the food. Potentialcontaminationfromthefoodhandlingenvironment,aswellasfromfoodingredients,mustbeconsideredforready‐to‐eatfoodsthatareexposedtotheenvironmentpriortopackagingifthepackagedfooddoesnotreceiveatreatmentorotherwiseincludeacontrolmeasure(suchasaformulationlethaltothepathogen)thatwouldsignificantlyminimizethepathogen.

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Thehazardevaluationmustconsidertheeffectofthefollowingonthesafetyofthefinishedfoodfortheintendedconsumer:

x Formulationofthefood;x Condition,functionanddesignofthefacilityandequipment;x Rawmaterialsandingredients;x Transportationpractices;x Manufacturing/processingprocedures;x Packagingactivitiesandlabelingactivities;x Storageanddistribution;x Intendedorreasonablyforeseeableuse;x Sanitation,includingemployeehygiene;andx Anyotherrelevantfactors,suchasweather‐relatedconcerns

inregardtoformationofsomenaturaltoxins.

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Thepreventivecontrolsrequireddependonwhich,ifany,hazardsaredeterminedtorequireapreventivecontrol.Whenahazardrequiringapreventivecontrolisassociatedwiththeproductionofthefood,anappropriatepreventivecontrolforthehazardmustbeaddressedintheFoodSafetyPlan.Potentialpreventivecontrolsfortheidentifiedhazard may be process controls, food allergen controls, sanitationcontrols, supply‐chain controls, other controls. A recall plan isrequired whenever a hazard requiring a preventive control isidentified.

Thepreventivecontrols required includeonly thoseappropriate tothefacilityandthefood,asdeterminedbyhazardanalysis.Preventivecontrolsmayormaynotbeatcriticalcontrolpoints(CCPs).Processcontrols are similar to controls addressed through HACCP CCPs.Required food allergen preventive controls are those determinedthroughhazardanalysisasnecessary toprotect food fromallergencross‐contact and to ensure that all food allergens are properlylabeled.

Required sanitation preventive controls are those determinedthrough hazard analysis as necessary to significantly minimize orprevent 1) environmental pathogens in a ready‐to‐eat (RTE) foodexposedtotheenvironmentpriortopackagingwherethepackagedfooddoesnotreceiveatreatmentthatwouldsignificantlyminimizethepathogen;2)biologicalhazardsinanRTEfoodduetoemployeehandling; and3) food allergenhazards.Other aspects of sanitationsuchaspestcontrol,safetyofwaterandemployeehealthdonotneedtobeinaFoodSafetyPlanunlesstheyaredeterminedtobehazardsrequiringapreventivecontrol.

Supply‐chaincontrols,implementedthroughasupply‐chainprogram,arerequiredforingredientsorrawmaterialsforwhichthereceivingfacility’shazardanalysisidentifiedahazardrequiringasupply‐chain‐applied control. Other preventive controls may be identified asappropriatebasedonthehazardanalysis.

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There are certain circumstances in which you are not required toimplement a preventive control even when you identify a hazardrequiringapreventivecontrol(identifiedhazard).Theseinclude:

x ou determine that the type of food made could not beconsumedwithoutapplyinganappropriatecontrol.Examplesmay include raw agricultural commodities such as cocoabeans, coffee beans and grains. ou must document theconsiderationsthatleadtothisconclusion.

x ourelyonacustomertoensurethattheidentifiedhazardissignificantlyminimizedorprevented. For this to apply, youmust:

o discloseindocumentsthataccompanythefood,inamannerconsistentwiththepracticeoftrade,thatitis“notprocessedtocontrol identifiedhazard ”.

o obtain annual written assurance that the hazard isbeingcontrolled.

This can apply whether or not your customer is subject to thepreventivecontrolsregulations.Ifyourcustomerdoesnotcontrolthehazard (e.g., they send it on for further processing), additionalassurancesarerequired.Refertotheregulationforspecifics.A facility providing the type of written assurance described abovemustdocumenttheactiontakentocontrolthehazard.

The situations are described in 21 CFR 117.136 and 117.137. Read these provisions carefully if you think this applies to you.

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Arecallplanisrequiredwhenahazardrequiringapreventivecontrolisidentifiedforafood.Itincludeswrittenprocedurestofollowwhena recall is needed and assigns responsibilities to do so. Theseproceduresincludehowyouwill:

1) inform customers that the food is being recalled, includinghowtoreturnordisposeoftheaffectedfood;

2) notifythepublicaboutanyhazardpresentedbythefoodwhenappropriatetoprotectpublichealth,

3) conduct effectiveness checks to verify that your customersreceivednotificationandremovedtherecalledproduct,and

4) appropriately dispose of the recalled food throughreprocessing, reworking, diverting to a use that does notpresentasafetyconcern,ordestroyingthefood.

Note that reanalysis is also required for other preventive controls in 21 CFR 117.170.

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Process,foodallergenandsanitationpreventivecontrolsallrequiremonitoring,asappropriate,toensureeffectivenessofthepreventivecontrol. Predefined corrective actions, or corrections for certainsanitationissues(e.g.,observationofuncleanequipmentbeforeuse),and verification are also required, as appropriate, to ensurepreventivecontrolsareeffective.

Supply‐chain programs do not require monitoring; however,corrective actions or corrections (as appropriate) are required asnecessaryandareviewofrecordsofsupplierverificationactivitiesmustbeconducted.Aswithotherpreventivecontrols,reanalysismaybe needed for supply‐chain programs when issues are identified,whenanewingredient isaddedorwhenanewsupplierreplacesacurrentsupplierforthesameingredient.

Therecallplanisnotsubjecttothesemanagementcomponents.

Written procedures on how you monitor preventive controls arerequired as appropriate to the preventive control. The proceduresmustdescribethefrequencyofmonitoring.

Refrigeration temperature monitoring records may be eitheraffirmation records (demonstrating that the temperature iscontrolled in the required limits) or exception records(demonstrating loss of temperature control). An example of anexception record other than refrigeration is x‐ray detection forforeignmaterial.Norecordisgeneratedwhennoforeignmaterialispresent – the record is only generated when foreign material ispresent,thusitisanexception.

Monitoringrecordsforpreventivecontrolsmustbeverifiedunderthedirectionofapreventivecontrolsqualifiedindividual.

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Corrective action procedures vary depending on the nature of thepreventivecontrolandhowitfitsintothefoodsafetysystem.Foreachpreventivecontrolrequiringacorrectiveactionprocedure(typicallyfor aprocesspreventive control),writtenprocedures are required.Thesecorrectiveactionshavefourelements:

1) identifyingtheproblemandcorrectingit,2) whennecessary,reducingthelikelihoodthattheproblemwill

recur,3) ensuringthataffectedfoodisevaluatedforsafety,and4) ensuringthatadulteratedfooddoesnotentercommerce.Ifit

does,arecalliswarranted.Allcorrectiveactionstakenmustbedocumentedinrecordsandtherecordsaresubjecttoverificationandrecordreview.

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Corrective action provisions also require written procedures toaddresstheactiontotakeinresponsetodetectionofapathogenorindicator organism in an RTE product that is being tested forverification. Similarly, procedures to respond to detection of anenvironmentalpathogenorindicatororganismmustbedocumented.The response to these situations will vary depending on thepreventive control itself, the facility, the food and the overall foodsafetysystem.

Ifthereisanunanticipatedproblemandaspecificcorrectiveactionprocedurehasnotbeenestablished,orapreventivecontrolisfoundto be ineffective (e.g., the process for the product is found to beinadequate), theFoodSafetyPlanmustbereanalyzedtodeterminewhetheritshouldbemodified.

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In some situations you may use corrections in place of correctiveactionifyoutakeactioninatimelymannertoidentifyandcorrectaminor and isolated problem that does not directly impact productsafety. For example, if equipment with a potential food allergenresidue is observed before production starts and the surface iscleanedbeforeproductionbegins,acorrectionisappropriate.

Verificationactivitiesarerequiredtoensurethatpreventivecontrolsareconsistentlyimplementedandeffective.Theyincludevalidation,and verification that monitoring is being conducted and thatappropriatecorrectiveactiondecisionsarebeingmade.Verificationof implementation and effectiveness includes reviewof calibration,producttestingandenvironmentalmonitoringrecords.ReanalysisoftheFoodSafetyPlanisanotherverificationactivity.

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Validation is “theprocessofobtainingandevaluatingscientificandtechnical evidence that a control measure, combination of controlmeasures, or the food safety plan as a whole, when properlyimplemented, is capable of effectively controlling the identifiedhazards.” Preferably, validation is conducted before production;however,itisrecognizedthaton‐linevalidationmaybenecessary,forexampletoaccountforprocessvariation.Inanycase,validationmustbe completewithin the first 0daysofproductionor a reasonableamount of timewith written justification by a preventive controlsqualifiedindividual.

Validationisnotrequiredforfoodallergen,sanitationorsupply‐chainprogramcontrols,butmaybeuseful.Validationisnotrequiredfortherecallplan.

Verification of implementation and effectiveness includes, asappropriatetothefacility,thefoodandthenatureofthepreventivecontrol,activitiessuchascalibration,producttesting,environmentalmonitoring and records review. These are activities that help youassesswhetherwhatyouaredoingiscontrollingthehazards.

Calibrationisrequiredforinstrumentsusedforprocessmonitoringand verification. Product testing for a pathogen (or appropriateindicator) or other hazard is required for hazards requiring apreventivecontrolwhenappropriateforverification.Environmentalmonitoringisarequiredverificationactivitywhenanenvironmentalpathogenisidentifiedasahazardrequiringapreventivecontrol.

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Reviewofmonitoringandcorrectiveactionrecordsisrequiredwithinsevenworkingdaysaftertherecordwascreatedunlessapreventivecontrols qualified individual prepares or oversees writtenjustification fora longerreasonable timeframe.Calibrationrecords,producttestingrecordsandenvironmentmonitoringrecords,whenapplicable, must be reviewed within a reasonable time after therecordswerecreated.Reviewofrelevantsupplierandsupply‐chainverificationrecordsisalsorequiredinareasonabletimeframe.

WrittenproceduresrequiredforFoodSafetyPlansvarydependingonthefacility,thefood,thenatureofthepreventivecontrolandtheroleofthatcontrolinthefacility’sfoodsafetysystem.Writtenproceduresarerequiredforcalibratingmonitoringandverificationequipmentintheplan,aswellasthefrequencyofcalibration.Whenproducttesting

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is required, scientifically valid procedures must be used andidentified.Writtenproceduresmustidentifythetestmicroorganismsor analytes, how the samples relate to the lot, the number andfrequencyoftakingsamples,thetestsconductedandmethodsused,thelaboratoryconductingthetest,andcorrectiveactionproceduresto implement for results that do not meet requirements. Similarproceduresarerequiredwhenenvironmentalmonitoringisrequired.

ReanalysisoftheFoodSafetyPlanisanotherverificationactivity.Thefullplanmustbereviewedatleastevery3yearstoensurethatitstillaccurately reflects the preventive controls needed. FDA may alsodetermine that reanalysis is necessary in response to newhazardsanddevelopmentsinscientificunderstanding.

Reanalysis of applicable sections of the plan is also requiredwhenthereisasignificantchangeintheoperationorincurrentknowledgethatmayincreaseconcernregardinganeworpreviously identifiedhazard.Reanalysismayalsoberequiredafteranunanticipatedfoodsafetyproblemoccursorwhenapreventivecontrol,combinationofpreventivecontrolsortheFoodSafetyPlanitselfisineffective.

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Whenreanalysisisconducted,inmostcasesitmusttakeplacebeforeany changes aremade to the Food Safety Plan.When necessary todemonstrate control measures can be implemented as designed,validation activities needed as a result of the reanalysis may takeplaceinthefirst 0daysofproduction.Ifyourreanalysisindicatesanincreasedfoodsafetyrisk,yourFoodSafetyPlanmustberevised.Ifyoudeterminethatnorevisionisnecessary,thebasisforthatdecisionmustalsobedocumented.ApreventivecontrolsqualifiedindividualmustperformoroverseereanalysisoftheFoodSafetyPlan.

Apreventivecontrolsqualified individual is required todeveloporoversee development of the Food Safety Plan, validation of thepreventivecontrolsusedintheplan,reviewofrecordsandreanalysisoftheFoodSafetyPlan.Additionaltasksthatmustbeperformedor

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overseenbyapreventivecontrolsqualifiedindividualinvolvewrittenjustification in situations where expected timeframes for certainactivities are not met. These include justification for completingvalidationactivitiesafter 0daysoffirstproductionordeterminingthatvalidationisnotrequired,justificationforreviewofmonitoringand corrective action records exceeding 7 working days, anddetermining that it is appropriate to perform reanalysis andvalidationofadditionalpreventivecontrols inaperiod longer thanthefirst 0daysofproduction.

Certain activities for preventive controls must be overseen by apreventive controls qualified individual. There are essentially twowaysforanindividualtoachievethisrecognition.Thefirstwayistosuccessfullycompletetraininginthedevelopmentandapplicationofrisk‐basedpreventivecontrols,suchasattendingthis trainingclassand successfully completing the exercises. Training must bedocumented in records, including thedate, typeof training,persontrainedetc.

The second way is for an individual to be qualified through jobexperience. These individuals will need to understand the specificregulatoryrequirementsof thePreventiveControls forHumanFoodregulation,whichdiffersomewhatfromrequirements inotherfoodsafetyregulationsandstandards.

Someorganizationsmayhaveoneormorepeopleonstaff thatcanperform all of the functions that require oversight by a preventivecontrols qualified individual. Other organizations may choose toengage a technical expert to help with certain aspects, such asdevelopment of the hazard analysis, validating preventive controlsand other highly technical aspects of this role. This can varyconsiderably depending on the complexity of the product and thepotentialfoodsafetyhazardsforthefoodandfacility.

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Auditingmay be a required verification activity, for example for asupply‐chainprogram.Theauditormustbeaqualifiedindividualandbe qualified to do the audit through a combination of education,auditing experience (including an understanding of the commodityinvolved) and auditing training. Records of such experience arerequired.

ThePreventiveControlsforHumanFoodregulationalsohasspecificrequirementsforimplementationrecords. oumayrecallthat21CFR117.136 described situations where a preventive control is notrequired to be implemented, such as when the food could not beconsumedwithoutapplicationofanappropriatecontrolorwhentheprocessingfacilityreceivesassurancesthattheircustomerwillapplythecontrol.Recordsdocumentingthesesituationsarerequired.Other

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records that are more common include those that documentmonitoring activities of the preventive controls identified in thehazard analysis; records of corrective actions associated withpreventivecontrols;recordsdocumentingtrainingintheprinciplesoffood hygiene and food safety for individuals engaged inmanufacturing,processing,packingorholdingfood;records forthesupply‐chain program, records of training for preventive controlsqualified individuals and qualified auditors, and several differenttypes of verification activities. Records that document verificationinclude,asapplicable:

x validation records that establish the scientific and technicalbasisofthepreventivecontrols,

x verificationofmonitoringrecordstoensurethatcriticallimitsandotherparametersweremet,

x verification of corrective action records to ensure thatappropriateactionswerecarriedoutandcompleted,

x calibration of process monitoring and verificationinstrumentstoensurethatthedatatheyprovideareaccurate,

x recordsofproducttesting,x recordsofenvironmentalmonitoring,x recordtodocumentrecordreview,andx reanalysisoftheFoodSafetyPlan.

Subpart D – Modified Requirements

There aremodified requirements for certain facilities such as verysmallbusinesses(i.e.,aqualified facility)orwarehouses thatsolelyengage in storage of unexposed packaged food. These modifiedrequirementsareaddressed in21CFR117SubpartD.Consult thissection if you are a qualified facility. A brief discussion of

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requirements that apply to facilities solely engaged in storage ofunexposedpackagedfoodfollows.

Forfacilitiesthatstorerefrigeratedpackagedfood(e.g.,refrigeratedstoragewarehouses), therearerequirements for time/temperaturecontrol if the product can support pathogen growth or toxinproduction. These include monitoring temperatures and takingcorrectiveactionwhenappropriate.Verificationactivitiesrelatedtotemperaturemonitoringalsoapply.

Subpart E – Withdrawal of a Qualified Facility Exemption

21CFR117SubpartEdescribesthecircumstances,proceduresandrequirements forwithdrawingaqualified facility exemption. If youbelievethatyouareaqualified facility,youshouldbecomefamiliar

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with the provisions for withdrawal and reinstatement of theexemption forqualified facilities.When such situations arise, otherassistanceisneeded,includingfromlegalcounsel,toassurethatthelegalrequirementsarefulfilled.

Subpart F ‐ Records

21CFR117SubpartFdescribesrequirements forrecords.Recordsmust be kept as original records, true copies (e.g., photocopies,pictures, scanned copies, microfilm, microfiche or other accuratereproductions of the original) or electronic records. They mustcontain the actual values and observations obtained duringmonitoringand,asappropriate,duringverificationactivities.Recordsmustbeaccurate,indelible,legibleandcreatedconcurrentlywiththeactivitybeingdocumented.Recordsmustbeasdetailedasnecessarytoprovideahistoryoftheworkperformed,including:

x adequateinformationtoidentifytheplantorfacility(e.g.,thenameandwhennecessarythelocationofthefacility),

x the date and, when appropriate, time of the activitydocumented,

x thesignatureorinitialsofthepersonperformingtheactivityand

x where appropriate, the identity of the product and the lotcode,ifany.

TheFoodSafetyPlanmustbesignedanddatedbytheowner,operatororagentinchargeofthefacilityuponinitialcompletionanduponanymodification.

Allrequiredrecordsmustberetainedatthefacilityforatleast2yearsafter the date they were prepared. Records related to the generaladequacyof theequipment orprocessesbeingusedby the facility,includingscientificstudiesandevaluations,mustberetained forat

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least 2 years after their use is discontinued. This applies to FoodSafetyPlansthatarenolongerusedbecausetheyhavebeenupdated,validationrecordsforprocessesnolongerused,andpotentiallyotherrecords.

ExceptfortheFoodSafetyPlan,offsitestorageofrequiredrecordsispermitted if they can be retrieved and provided onsite within 24hours of the request for official review. Electronic records areconsideredonsiteiftheycanbeaccessedfromanonsitelocation.Allrecordsrequiredmustbemadepromptlyavailableforofficialreviewand copying upon oral or written request. Records required aresubjecttodisclosurerequirementsunder21CFRPart20.

Existingrecords,suchasrecordskepttocomplywithotherfederal,state or local regulations or any other reason,may be used if theycontain all the required information. ou can supplement existingrecordsiftheyaremissingsomeoftherequiredelements. oudonothavetokeepyourrecordsasonesetofrecords–anynewinformationnotonanexistingrecordcanbekeptseparatelyorcombinedwiththeexistingrecords.

Any required written assurance (21 CFR 117.335) related toapplicationofapreventivecontrolelsewhereinthesupply‐chain(see21CFR117.136and117.430)mustcontaintheeffectivedate,printednames and signatures of authorized officials, and relevantinformationregardingacknowledgementoflegalresponsibility.Readthesectioncarefullyifitappliestoyourfacility.

Subpart G – Supply‐chain Program

Hazardsrequiringapreventivecontrolforwhichyourelyonsuppliereffortsaremanagedthroughyoursupply‐chainprogram.21CFR117SubpartGcoversrequirementstoestablishandimplementasupply‐chainprogram,generalrequirements,responsibilitiesofthereceiving

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facility, using approved suppliers, determining appropriateverification activities, conducting those activities, onsite audits andrecordsrequiredforyoursupply‐chainprogram.

Asupply‐chainprogramisrequiredtoaddressonlythoseingredientsandrawmaterialsthatpresentpotentialhazardsrequiringasupply‐chain applied control (i.e., the hazard is controlled before receipt).our supply‐chain program must be written and you must haverecordstodemonstratethattheprogramisimplemented.

For these ingredients, youmust use approved suppliers. For thesesuppliers,youmustdeterminetheappropriatesupplierverificationactivities, thenconductanddocumentthoseactivities.Sometimesasupply‐chain‐applied control is applied by an entity other than thereceiving facility’s supplier (e.g., when a “non‐supplier” applies

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controlstocertainproduce(i.e.,producesubjecttotheproducesafetyrule),becausegrowing,harvesting,andpackingactivitiesareunderdifferent management). The receiving facility must (1) verify thesupply‐chain‐applied control; or (2) obtain documentation ofverification fromanother entity (e.g., supplier producedistributor)usingoneoftheverificationproceduresthatisdiscussedinthenextslide.

The activities listed above are appropriate supplier verificationactivities forrawmaterialsandother ingredientsrequiringsupply‐chain‐applied control. In determining which approach to use,consider:

x theresultsofthehazardanalysisincludingthenatureofthehazardrequiringasupply‐chain‐appliedcontrol;

x thesupplier’sprocedures,processesandpracticesrelatedtothesafetyoftheingredient;

x relevantFDAfoodsafetyregulationsandinformationsuchaswarninglettersandimportalertsrelatedtothefoodandthesupplier’scompliancewiththese;

x the supplier’s food safety history including applicable testresults,auditresults,responsetocorrectproblems,etc.,and

x storageandtransportationpractices.Onsite audits must be performed by a qualified auditor and mustinclude review of the supplier’s written plan (e.g., HACCP plan orotherFoodSafetyPlanifthesupplierissubjecttoanFDAfoodsafetyregulation).Anappropriate inspectionconductedbyFDA (orotherspecified agency officials) for compliance with FDA food safetyregulationsmaybesubstitutedforanonsiteaudit. If thisappliestooneofyoursuppliers,refertotheregulationfordetails.

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Ifyoudeterminethroughverificationactivitiesthatthesupplierisnotcontrollingthehazard,youmusttakeactionanddocumenttheactiontakentoensurethatyourfoodisnotadulteratedormisbranded.

TheCurrentGoodManufacturingPractice,HazardAnalysis,andRisk‐BasedPreventiveControls forHumanFood regulation is intendedtofocuspreventivecontrolswheretheymattermost.GMPsarerequiredforallfacilitiesunlessanexemptionexists.Thiscoursefocuseson21CFR 117 Subpart C – Hazard Analysis and Risk‐based PreventiveControls for Human Food and Subpart G – Supply‐chain Program.More detailed information on other provisions can be obtainedthroughothermeans,suchasreadingtheregulation(seeAppendix1),throughothertrainingprogramsorthroughlegalcounsel.

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Where to Go for Help

RememberthatChapter7discussedtheFSPCAandtheFDATechnicalAssistance Networks and provided the links to both the FSPCAWebsite (www.iit.edu/ifsh/alliance) and the FDA Website at(www.fda.gov/FSMA).Thesenetworkswillworktogether–withFDAaddressinganswerstoregulationandpolicyinterpretationquestionsand FSPCA addressing scientific and technical questions, asappropriate.

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NOTES:

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APPENDIX 1: FDA Regulation on cGMP, Hazard Analysis, and Risk‐based Preventive Controls for Human Food

NOTE:NOTanofficialversion.Providedforreferenceonly.Includestechnicalamendments(22January2016)andcorrections(25January2016).

Title 21 of the Code of Federal Regulation Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food Subpart A – General Provisions § 117.1 Applicability and status. (a)Thecriteriaanddefinitionsinthispartapplyindeterminingwhetherafoodis:

(1)Adulteratedwithinthemeaningof:(i)Section402(a)(3)oftheFederalFood,Drug,andCosmeticActinthatthefoodhasbeenmanufacturedundersuchconditionsthatitisunfitforfood;or(ii)Section402(a)(4)oftheFederalFood,Drug,andCosmeticActinthatthefoodhasbeenprepared,packed,orheldunderinsanitaryconditionswherebyitmayhavebecomecontaminatedwithfilth,orwherebyitmayhavebeenrenderedinjurioustohealth;and

(2)Inviolationofsection361ofthePublicHealthServiceAct(42U.S.C.264).(b)Theoperationofafacilitythatmanufactures,processes,packs,orholdsfoodforsaleintheUnitedStatesiftheowner,operator,oragentinchargeofsuchfacilityisrequiredtocomplywith,andisnotincompliancewith,section418oftheFederalFood,Drug,andCosmeticActorsubpartC,D,E,F,orGofthispartisaprohibitedactundersection301(uu)oftheFederalFood,Drug,andCosmeticAct.(c)Foodcoveredbyspecificcurrentgoodmanufacturingpracticeregulationsalsoissubjecttotherequirementsofthoseregulations.§ 117.3 Definitions. Thedefinitionsandinterpretationsoftermsinsection201oftheFederalFood,Drug,andCosmeticActapplytosuchtermswhenusedinthispart.Thefollowingdefinitionsalsoapply:AcidfoodsoracidifiedfoodsmeansfoodsthathaveanequilibriumpHof4.6orbelow.Adequatemeansthatwhichisneededtoaccomplishtheintendedpurposeinkeepingwithgoodpublichealthpractice.Affiliatemeansanyfacilitythatcontrols,iscontrolledby,orisundercommoncontrolwithanotherfacility.Allergencross‐contactmeanstheunintentionalincorporationofafoodallergenintoafood.Auditmeansthesystematic,independent,anddocumentedexamination(throughobservation,investigation,recordsreview,discussionswithemployeesoftheauditedentity,and,asappropriate,samplingandlaboratoryanalysis)toassessanentity’sfoodsafetyprocessesandprocedures.Battermeansasemifluidsubstance,usuallycomposedofflourandotheringredients,intowhichprincipalcomponentsoffoodaredippedorwithwhichtheyarecoated,orwhichmaybeuseddirectlytoformbakeryfoods.Blanching,exceptfortreenutsandpeanuts,meansaprepackagingheattreatmentoffoodstuffsforanadequatetimeandatanadequatetemperaturetopartiallyorcompletelyinactivatethenaturallyoccurringenzymesandtoeffectotherphysicalorbiochemicalchangesinthefood.Calendardaymeanseverydayshownonthecalendar.Correctionmeansanactiontoidentifyandcorrectaproblemthatoccurredduringtheproductionoffood,withoutotheractionsassociatedwithacorrectiveactionprocedure(suchasactionstoreducethelikelihoodthattheproblemwillrecur,evaluateallaffectedfoodforsafety,andpreventaffectedfoodfromenteringcommerce).Criticalcontrolpointmeansapoint,step,orprocedureinafoodprocessatwhichcontrolcanbeappliedandisessentialtopreventoreliminateafoodsafetyhazardorreducesuchhazardtoanacceptablelevel.Defectactionlevelmeansalevelofanon‐hazardous,naturallyoccurring,unavoidabledefectatwhichFDAmayregardafoodproduct“adulterated”andsubjecttoenforcementactionundersection402(a)(3)oftheFederalFood,Drug,andCosmeticAct.Environmentalpathogenmeansapathogencapableofsurvivingandpersistingwithinthemanufacturing,processing,packing,orholdingenvironmentsuchthatfoodmaybecontaminatedandmayresultinfoodborneillnessifthatfoodis

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consumedwithouttreatmenttosignificantlyminimizetheenvironmentalpathogen.ExamplesofenvironmentalpathogensforthepurposesofthispartincludeListeriamonocytogenesandSalmonellaspp.butdonotincludethesporesofpathogenicsporeformingbacteria.Facilitymeansadomesticfacilityoraforeignfacilitythatisrequiredtoregisterundersection415oftheFederalFood,Drug,andCosmeticAct,inaccordancewiththerequirementsofpart1,subpartHofthischapter.Farmmeansfarmasdefinedin 1.227ofthischapter.FDAmeanstheFoodandDrugAdministration.Foodmeansfoodasdefinedinsection201(f)oftheFederalFood,Drug,andCosmeticActandincludesrawmaterialsandingredients.Foodallergenmeansamajorfoodallergenasdefinedinsection201(qq)oftheFederalFood,Drug,andCosmeticAct.Food‐contactsurfacesarethosesurfacesthatcontacthumanfoodandthosesurfacesfromwhichdrainage,orothertransfer,ontothefoodorontosurfacesthatcontactthefoodordinarilyoccursduringthenormalcourseofoperations.“Food‐contactsurfaces”includesutensilsandfood‐contactsurfacesofequipment.Full‐timeequivalentemployeeisatermusedtorepresentthenumberofemployeesofabusinessentityforthepurposeofdeterminingwhetherthebusinessqualifiesforthesmallbusinessexemption.Thenumberoffull‐timeequivalentemployeesisdeterminedbydividingthetotalnumberofhoursofsalaryorwagespaiddirectlytoemployeesofthebusinessentityandofallofitsaffiliatesandsubsidiariesbythenumberofhoursofworkin1year,2,080hours(i.e.,40hoursx52weeks).Iftheresultisnotawholenumber,rounddowntothenextlowestwholenumber.Harvestingappliestofarmsandfarmmixed‐typefacilitiesandmeansactivitiesthataretraditionallyperformedonfarmsforthepurposeofremovingrawagriculturalcommoditiesfromtheplacetheyweregrownorraisedandpreparingthemforuseasfood.Harvestingislimitedtoactivitiesperformedonrawagriculturalcommodities,oronprocessedfoodscreatedbydrying/dehydratingarawagriculturalcommoditywithoutadditionalmanufacturing/processing,onafarm.Harvestingdoesnotincludeactivitiesthattransformarawagriculturalcommodityintoaprocessedfoodasdefinedinsection201(gg)oftheFederalFood,Drug,andCosmeticAct.Examplesofharvestingincludecutting(orotherwiseseparating)theedibleportionoftherawagriculturalcommodityfromthecropplantandremovingortrimmingpartoftherawagriculturalcommodity(e.g.,foliage,husks,rootsorstems).Examplesofharvestingalsoincludecooling,fieldcoring,filtering,gathering,hulling,shelling,sifting,threshing,trimmingofouterleavesof,andwashingrawagriculturalcommoditiesgrownonafarm.Hazardmeansanybiological,chemical(includingradiological),orphysicalagentthathasthepotentialtocauseillnessorinjury.Hazardrequiringapreventivecontrolmeansaknownorreasonablyforeseeablehazardforwhichapersonknowledgeableaboutthesafemanufacturing,processing,packing,orholdingoffoodwould,basedontheoutcomeofahazardanalysis(whichincludesanassessmentoftheseverityoftheillnessorinjuryifthehazardweretooccurandtheprobabilitythatthehazardwilloccurintheabsenceofpreventivecontrols),establishoneormorepreventivecontrolstosignificantlyminimizeorpreventthehazardinafoodandcomponentstomanagethosecontrols(suchasmonitoring,correctionsorcorrectiveactions,verification,andrecords)asappropriatetothefood,thefacility,andthenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem.Holdingmeansstorageoffoodandalsoincludesactivitiesperformedincidentaltostorageofafood(e.g.,activitiesperformedforthesafeoreffectivestorageofthatfood,suchasfumigatingfoodduringstorage,anddrying/dehydratingrawagriculturalcommoditieswhenthedrying/dehydratingdoesnotcreateadistinctcommodity(suchasdrying/dehydratinghayoralfalfa)).Holdingalsoincludesactivitiesperformedasapracticalnecessityforthedistributionofthatfood(suchasblendingofthesamerawagriculturalcommodityandbreakingdownpallets),butdoesnotincludeactivitiesthattransformarawagriculturalcommodityintoaprocessedfoodasdefinedinsection201(gg)oftheFederalFood,Drug,andCosmeticAct.Holdingfacilitiescouldincludewarehouses,coldstoragefacilities,storagesilos,grainelevators,andliquidstoragetanks.Knownorreasonablyforeseeablehazardmeansabiological,chemical(includingradiological),orphysicalhazardthatisknowntobe,orhasthepotentialtobe,associatedwiththefacilityorthefood.Lotmeansthefoodproducedduringaperiodoftimeandidentifiedbyanestablishment’sspecificcode.Manufacturing/processingmeansmakingfoodfromoneormoreingredients,orsynthesizing,preparing,treating,modifyingormanipulatingfood,includingfoodcropsoringredients.Examplesofmanufacturing/processingactivitiesinclude:Baking,boiling,bottling,canning,cooking,cooling,cutting,distilling,drying/dehydratingrawagriculturalcommoditiestocreateadistinctcommodity(suchasdrying/dehydratinggrapestoproduceraisins),evaporating,eviscerating,extractingjuice,formulating,freezing,grinding,homogenizing,irradiating,labeling,milling,mixing,packaging(includingmodifiedatmospherepackaging),pasteurizing,peeling,rendering,treatingtomanipulateripening,trimming,washing,orwaxing.Forfarmsandfarmmixed‐typefacilities,manufacturing/processingdoesnotincludeactivitiesthatarepartofharvesting,packing,orholding.Microorganismsmeansyeasts,molds,bacteria,viruses,protozoa,andmicroscopicparasitesandincludesspeciesthatarepathogens.Theterm“undesirablemicroorganisms”includesthosemicroorganismsthatarepathogens,thatsubjectfoodtodecomposition,thatindicatethatfoodiscontaminatedwithfilth,orthatotherwisemaycausefoodtobeadulterated.

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Mixed‐typefacilitymeansanestablishmentthatengagesinbothactivitiesthatareexemptfromregistrationundersection415oftheFederalFood,Drug,andCosmeticActandactivitiesthatrequiretheestablishmenttoberegistered.Anexampleofsuchafacilityisa“farmmixed‐typefacility,”whichisanestablishmentthatisafarm,butalsoconductsactivitiesoutsidethefarmdefinitionthatrequiretheestablishmenttoberegistered.Monitormeanstoconductaplannedsequenceofobservationsormeasurementstoassesswhethercontrolmeasuresareoperatingasintended.Packingmeansplacingfoodintoacontainerotherthanpackagingthefoodandalsoincludesre‐packingandactivitiesperformedincidentaltopackingorre‐packingafood(e.g.,activitiesperformedforthesafeoreffectivepackingorre‐packingofthatfood(suchassorting,culling,grading,andweighingorconveyingincidentaltopackingorre‐packing)),butdoesnotincludeactivitiesthattransformarawagriculturalcommodityintoaprocessedfoodasdefinedinsection201(gg)oftheFederalFood,Drug,andCosmeticAct.Pathogenmeansamicroorganismofpublichealthsignificance.Pestreferstoanyobjectionableanimalsorinsectsincludingbirds,rodents,flies,andlarvae.Plantmeansthebuildingorstructureorpartsthereof,usedfororinconnectionwiththemanufacturing,processing,packing,orholdingofhumanfood.Preventivecontrolsmeansthoserisk‐based,reasonablyappropriateprocedures,practices,andprocessesthatapersonknowledgeableaboutthesafemanufacturing,processing,packing,orholdingoffoodwouldemploytosignificantlyminimizeorpreventthehazardsidentifiedunderthehazardanalysisthatareconsistentwiththecurrentscientificunderstandingofsafefoodmanufacturing,processing,packing,orholdingatthetimeoftheanalysis.Preventivecontrolsqualifiedindividualmeansaqualifiedindividualwhohassuccessfullycompletedtraininginthedevelopmentandapplicationofrisk‐basedpreventivecontrolsatleastequivalenttothatreceivedunderastandardizedcurriculumrecognizedasadequatebyFDAorisotherwisequalifiedthroughjobexperiencetodevelopandapplyafoodsafetysystem.ualifiedauditormeansapersonwhoisaqualifiedindividualasdefinedinthispartandhastechnicalexpertiseobtained

througheducation,training,orexperience(oracombinationthereof)necessarytoperformtheauditingfunctionasrequiredby 117.180(c)(2).Examplesofpotentialqualifiedauditorsinclude:

(1)Agovernmentemployee,includingaforeigngovernmentemployee;and(2)Anauditagentofacertificationbodythatisaccreditedinaccordancewithregulationsinpart1,subpartMofthischapter.

ualifiedend‐user,withrespecttoafood,meanstheconsumerofthefood(wherethetermconsumerdoesnotincludeabusiness);orarestaurantorretailfoodestablishment(asthosetermsaredefinedin 1.227ofthischapter)that:

(1)Islocated:(i)InthesameStateorthesameIndianreservationasthequalifiedfacilitythatsoldthefoodtosuchrestaurantorestablishment;or(ii)Notmorethan275milesfromsuchfacility;and

(2)Ispurchasingthefoodforsaledirectlytoconsumersatsuchrestaurantorretailfoodestablishment.ualifiedfacilitymeans(whenincludingthesalesbyanysubsidiary;affiliate;orsubsidiariesoraffiliates,collectively,of

anyentityofwhichthefacilityisasubsidiaryoraffiliate)afacilitythatisaverysmallbusinessasdefinedinthispart,orafacilitytowhichbothofthefollowingapply:

(1)Duringthe3‐yearperiodprecedingtheapplicablecalendaryear,theaverageannualmonetaryvalueofthefoodmanufactured,processed,packedorheldatsuchfacilitythatissolddirectlytoqualifiedend‐users(asdefinedinthispart)duringsuchperiodexceededtheaverageannualmonetaryvalueofthefoodsoldbysuchfacilitytoallotherpurchasers;and(2)Theaverageannualmonetaryvalueofallfoodsoldduringthe3‐yearperiodprecedingtheapplicablecalendaryearwaslessthan 500,000,adjustedforinflation.

ualifiedfacilityexemptionmeansanexemptionapplicabletoaqualifiedfacilityunder 117.5(a).ualifiedindividualmeansapersonwhohastheeducation,training,orexperience(oracombinationthereof)necessary

tomanufacture,process,pack,orholdcleanandsafefoodasappropriatetotheindividual’sassignedduties.Aqualifiedindividualmaybe,butisnotrequiredtobe,anemployeeoftheestablishment.ualitycontroloperationmeansaplannedandsystematicprocedurefortakingallactionsnecessarytopreventfoodfrom

beingadulterated.Rawagriculturalcommodityhasthemeaninggiveninsection201(r)oftheFederalFood,Drug,andCosmeticAct.Ready‐to‐eatfood(RTEfood)meansanyfoodthatisnormallyeateninitsrawstateoranyotherfood,includingaprocessedfood,forwhichitisreasonablyforeseeablethatthefoodwillbeeatenwithoutfurtherprocessingthatwouldsignificantlyminimizebiologicalhazards.ReceivingfacilitymeansafacilitythatissubjecttosubpartsCandGofthispartandthatmanufactures/processesarawmaterialorotheringredientthatitreceivesfromasupplier.Reworkmeansclean,unadulteratedfoodthathasbeenremovedfromprocessingforreasonsotherthaninsanitaryconditionsorthathasbeensuccessfullyreconditionedbyreprocessingandthatissuitableforuseasfood.

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Safe‐moisturelevelisalevelofmoisturelowenoughtopreventthegrowthofundesirablemicroorganismsinthefinishedproductundertheintendedconditionsofmanufacturing,processing,packing,andholding.Thesafemoisturelevelforafoodisrelatedtoitswateractivity(aw).Anawwillbeconsideredsafeforafoodifadequatedataareavailablethatdemonstratethatthefoodatorbelowthegivenawwillnotsupportthegrowthofundesirablemicroorganisms.Sanitizemeanstoadequatelytreatcleanedsurfacesbyaprocessthatiseffectiveindestroyingvegetativecellsofpathogens,andinsubstantiallyreducingnumbersofotherundesirablemicroorganisms,butwithoutadverselyaffectingtheproductoritssafetyfortheconsumer.Significantlyminimizemeanstoreducetoanacceptablelevel,includingtoeliminate.Smallbusinessmeans,forpurposesofthispart,abusiness(includinganysubsidiariesandaffiliates)employingfewerthan500full‐timeequivalentemployees.Subsidiarymeansanycompanywhichisownedorcontrolleddirectlyorindirectlybyanothercompany.Suppliermeanstheestablishmentthatmanufactures/processesthefood,raisestheanimal,orgrowsthefoodthatisprovidedtoareceivingfacilitywithoutfurthermanufacturing/processingbyanotherestablishment,exceptforfurthermanufacturing/processingthatconsistssolelyoftheadditionoflabelingorsimilaractivityofademinimisnature.Supply‐chain‐appliedcontrolmeansapreventivecontrolforahazardinarawmaterialorotheringredientwhenthehazardintherawmaterialorotheringredientiscontrolledbeforeitsreceipt.Unexposedpackagedfoodmeanspackagedfoodthatisnotexposedtotheenvironment.Validationmeansobtainingandevaluatingscientificandtechnicalevidencethatacontrolmeasure,combinationofcontrolmeasures,orthefoodsafetyplanasawhole,whenproperlyimplemented,iscapableofeffectivelycontrollingtheidentifiedhazards.Verificationmeanstheapplicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,todeterminewhetheracontrolmeasureorcombinationofcontrolmeasuresisorhasbeenoperatingasintendedandtoestablishthevalidityofthefoodsafetyplan.Verysmallbusinessmeans,forpurposesofthispart,abusiness(includinganysubsidiariesandaffiliates)averaginglessthan 1,000,000,adjustedforinflation,peryear,duringthe3‐yearperiodprecedingtheapplicablecalendaryearinsalesofhumanfoodplusthemarketvalueofhumanfoodmanufactured,processed,packed,orheldwithoutsale(e.g.,heldforafee).Wateractivity(aw)isameasureofthefreemoistureinafoodandisthequotientofthewatervaporpressureofthesubstancedividedbythevaporpressureofpurewateratthesametemperature.Writtenproceduresforreceivingrawmaterialsandotheringredientsmeanswrittenprocedurestoensurethatrawmaterialsandotheringredientsarereceivedonlyfromsuppliersapprovedbythereceivingfacility(or,whennecessaryandappropriate,onatemporarybasisfromunapprovedsupplierswhoserawmaterialsorotheringredientsaresubjectedtoadequateverificationactivitiesbeforeacceptanceforuse).oumeans,forpurposesofthispart,theowner,operator,oragentinchargeofafacility.

§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food. (a)Applicability.

(1)Themanagementofanestablishmentmustensurethatallindividualswhomanufacture,process,pack,orholdfoodsubjecttosubpartsBandFofthispartarequalifiedtoperformtheirassignedduties.(2)Theowner,operator,oragentinchargeofafacilitymustensurethatallindividualswhomanufacture,process,pack,orholdfoodsubjecttosubpartC,D,E,F,orGofthispartarequalifiedtoperformtheirassignedduties.

(b) ualificationsofallindividualsengagedinmanufacturing,processing,packing,orholdingfood.Eachindividualengagedinmanufacturing,processing,packing,orholdingfood(includingtemporaryandseasonalpersonnel)orinthesupervisionthereofmust:

(1)Beaqualifiedindividualasthattermisdefinedin 117.3‐‐i.e.,havetheeducation,training,orexperience(oracombinationthereof)necessarytomanufacture,process,pack,orholdcleanandsafefoodasappropriatetotheindividual’sassignedduties;and(2)Receivetrainingintheprinciplesoffoodhygieneandfoodsafety,includingtheimportanceofemployeehealthandpersonalhygiene,asappropriatetothefood,thefacilityandtheindividual’sassignedduties.

(c)Additionalqualificationsofsupervisorypersonnel.Responsibilityforensuringcompliancebyindividualswiththerequirementsofthispartmustbeclearlyassignedtosupervisorypersonnelwhohavetheeducation,training,orexperience(oracombinationthereof)necessarytosupervisetheproductionofcleanandsafefood.(d)Records.Recordsthatdocumenttrainingrequiredbyparagraph(b)(2)ofthissectionmustbeestablishedandmaintained.§ 117.5 Exemptions. (a)ExceptasprovidedbysubpartEofthispart,subpartsCandGofthispartdonotapplytoaqualifiedfacility. ualifiedfacilitiesaresubjecttothemodifiedrequirementsin 117.201.(b)SubpartsCandGofthispartdonotapplywithrespecttoactivitiesthataresubjecttopart123ofthischapter(FishandFisheryProducts)atafacilityifyouarerequiredtocomplywith,andareincompliancewith,part123ofthischapterwithrespecttosuchactivities.

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(c)SubpartsCandGofthispartdonotapplywithrespecttoactivitiesthataresubjecttopart120ofthischapter(HazardAnalysisandCriticalControlPoint(HACCP)Systems)atafacilityifyouarerequiredtocomplywith,andareincompliancewith,part120ofthischapterwithrespecttosuchactivities.(d)(1)SubpartsCandGofthispartdonotapplywithrespecttoactivitiesthataresubjecttopart113ofthischapter

(ThermallyProcessedLow‐AcidFoodsPackagedinHermeticallySealedContainers)atafacilityifyouarerequiredtocomplywith,andareincompliancewith,part113ofthischapterwithrespecttosuchactivities.(2)Theexemptioninparagraph(d)(1)ofthissectionisapplicableonlywithrespecttothemicrobiologicalhazardsthatareregulatedunderpart113ofthischapter.

(e)SubpartsCandGdonotapplytoanyfacilitywithregardtothemanufacturing,processing,packaging,orholdingofadietarysupplementthatisincompliancewiththerequirementsofpart111ofthischapter(CurrentGoodManufacturingPracticeinManufacturing,Packaging,Labeling,orHoldingOperationsforDietarySupplements)andsection761oftheFederalFood,Drug,andCosmeticAct(SeriousAdverseEventReportingforDietarySupplements).(f)SubpartsCandGofthispartdonotapplytoactivitiesofafacilitythataresubjecttosection41 oftheFederalFood,Drug,andCosmeticAct(StandardsforProduceSafety).(g)(1)Theexemptioninparagraph(g)(3)ofthissectionappliestopackingorholdingofprocessedfoodsonafarm

mixed‐typefacility,exceptforprocessedfoodsproducedbydrying/dehydratingrawagriculturalcommoditiestocreateadistinctcommodity(suchasdrying/dehydratinggrapestoproduceraisins,anddrying/dehydratingfreshherbstoproducedriedherbs),andpackagingandlabelingsuchcommodities,withoutadditionalmanufacturing/processing(suchaschoppingandslicing),thepackingandholdingofwhicharewithinthe“farm”definitionin 1.227ofthischapter.Activitiesthatarewithinthe“farm”definition,whenconductedonafarmmixed‐typefacility,arenotsubjecttotherequirementsofsubpartsCandGofthispartandthereforedonotneedtobespecifiedintheexemption.(2)Forthepurposesofparagraphs(g)(3)and(h)(3)ofthissection,thefollowingtermsdescribethefoodsassociatedwiththeactivity/foodcombinations.Severalfoodsthatarefruitsorvegetablesareseparatelyconsideredforthepurposesoftheseactivity/foodcombinations(i.e.,coffeebeans,cocoabeans,freshherbs,peanuts,sugarcane,sugarbeets,treenuts,seedsfordirectconsumption)toappropriatelyaddressspecifichazardsassociatedwiththesefoodsand/orprocessingactivitiesconductedonthesefoods.

(i)Dried/dehydratedfruitandvegetableproductsincludesonlythoseprocessedfoodproductssuchasraisinsanddriedlegumesmadewithoutadditionalmanufacturing/processingbeyonddrying/dehydrating,packaging,and/orlabeling.(ii)Otherfruitandvegetableproductsincludesthoseprocessedfoodproductsthathaveundergoneoneormoreofthefollowingprocesses:acidification,boiling,canning,coatingwiththingsotherthanwax/oil/resin,cooking,cutting,chopping,grinding,peeling,shredding,slicing,ortrimming.Examplesincludefloursmadefromlegumes(suchaschickpeaflour),pickles,andsnackchipsmadefrompotatoesorplantains.Examplesalsoincludedriedfruitandvegetableproductsmadewithadditionalmanufacturing/processing(suchasdriedappleslices;pitted,driedplums,cherries,andapricots;andsulfitedraisins).Thiscategorydoesnotincludedried/dehydratedfruitandvegetableproductsmadewithoutadditionalmanufacturing/processingasdescribedinparagraph(g)(2)(i)ofthissection.Thiscategoryalsodoesnotincludeproductsthatrequiretime/temperaturecontrolforsafety(suchasfresh‐cutfruitsandvegetables).(iii)Peanutandtreenutproductsincludesprocessedfoodproductssuchasroastedpeanutsandtreenuts,seasonedpeanutsandtreenuts,andpeanutandtreenutflours.(iv)Processedseedsfordirectconsumptionincludeprocessedfoodproductssuchasroastedpumpkinseeds,roastedsunflowerseeds,androastedflaxseeds.(v)Dried/dehydratedherbandspiceproductsincludesonlyprocessedfoodproductssuchasdriedintactherbsmadewithoutadditionalmanufacturing/processingbeyonddrying/dehydrating,packaging,and/orlabeling.(vi)Otherherbandspiceproductsincludesthoseprocessedfoodproductssuchaschoppedfreshherbs,choppedorgrounddriedherbs(includingtea),herbalextracts(e.g.,essentialoils,extractscontainingmorethan20percentethanol,extractscontainingmorethan35percentglycerin),driedherb‐orspice‐infusedhoney,anddriedherb‐orspice‐infusedoilsand/orvinegars.Thiscategorydoesnotincludedried/dehydratedherbandspiceproductsmadewithoutadditionalmanufacturing/processingbeyonddrying/dehydrating,packaging,and/orlabelingasdescribedinparagraph(g)(2)(v)ofthissection.Thiscategoryalsodoesnotincludeproductsthatrequiretime/temperaturecontrolforsafety,suchasfreshherb‐infusedoils.(vii)Grainsincludebarley,dent‐orflint‐corn,sorghum,oats,rice,rye,wheat,amaranth,quinoa,buckwheatandoilseedsforoilextraction(suchascottonseed,flaxseed,rapeseed,soybeans,andsunflowerseed).(viii)Milledgrainproductsincludeprocessedfoodproductssuchasflour,bran,andcornmeal.(ix)Bakedgoodsincludeprocessedfoodproductssuchasbreads,brownies,cakes,cookies,andcrackers.Thiscategorydoesnotincludeproductsthatrequiretime/temperaturecontrolforsafety,suchascream‐filledpastries.

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(x)Othergrainproductsincludeprocessedfoodproductssuchasdriedcereal,driedpasta,oatflakes,andpopcorn.Thiscategorydoesnotincludemilledgrainproductsasdescribedinparagraph(g)(2)(viii)ofthissectionorbakedgoodsasdescribedinparagraph(g)(2)(ix)ofthissection.

(3)SubpartsCandGofthispartdonotapplytoon‐farmpackingorholdingoffoodbyasmallorverysmallbusiness,and 117.201doesnotapplytoon‐farmpackingorholdingoffoodbyaverysmallbusiness,iftheonlypackingandholdingactivitiessubjecttosection418oftheFederalFood,Drug,andCosmeticActthatthebusinessconductsarethefollowinglow‐riskpackingorholdingactivity/foodcombinations‐‐i.e.,packing(orre‐packing)(includingweighingorconveyingincidentaltopackingorre‐packing);sorting,culling,orgradingincidentaltopackingorstoring;andstoring(ambient,coldandcontrolledatmosphere)of:

(i)Bakedgoods(e.g.,breadandcookies);(ii)Candy(e.g.,hardcandy,fudge,maplecandy,maplecream,nutbrittles,taffy,andtoffee);(iii)Cocoabeans(roasted);(iv)Cocoaproducts;(v)Coffeebeans(roasted);(vi)Gamemeatjerky;(vii)Gums,latexes,andresinsthatareprocessedfoods;(viii)Honey(pasteurized);(ix)Jams,jellies,andpreserves;(x)Milledgrainproducts(e.g.,flour,bran,andcornmeal);(xi)Molassesandtreacle;(xii)Oils(e.g.,oliveoilandsunflowerseedoil);(xiii)Otherfruitandvegetableproducts(e.g.,floursmadefromlegumes;pitted,driedfruits;sliced,driedapples;snackchips);(xiv)Othergrainproducts(e.g.,driedpasta,oatflakes,andpopcorn);(xv)Otherherbandspiceproducts(e.g.,choppedorgrounddriedherbs,herbalextracts);(xvi)Peanutandtreenutproducts(e.g.,roastedpeanutsandtreenutflours);(xvii)Processedseedsfordirectconsumption(e.g.,roastedpumpkinseeds);(xviii)Softdrinksandcarbonatedwater;(xix)Sugar;(xx)Syrups(e.g.,maplesyrupandagavesyrup);(xxi)Trailmixandgranola;(xxii)Vinegar;and(xxiii)Anyotherprocessedfoodthatdoesnotrequiretime/temperaturecontrolforsafety(e..g.,vitamins,minerals,anddietaryingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform).

(h)(1)Theexemptioninparagraph(h)(3)ofthissectionappliestomanufacturing/processingoffoodsonafarmmixed‐typefacility,exceptformanufacturing/processingthatiswithinthe“farm”definitionin 1.227ofthischapter.Drying/dehydratingrawagriculturalcommoditiestocreateadistinctcommodity(suchasdrying/dehydratinggrapestoproduceraisins,anddrying/dehydratingfreshherbstoproducedriedherbs),andpackagingandlabelingsuchcommodities,withoutadditionalmanufacturing/processing(suchaschoppingandslicing),arewithinthe“farm”definitionin 1.227ofthischapter.Inaddition,treatmenttomanipulateripeningofrawagriculturalcommodities(suchasbytreatingproducewithethylenegas),andpackagingandlabelingthetreatedrawagriculturalcommodities,withoutadditionalmanufacturing/processing,iswithinthe“farm”definition.Inaddition,coatingintactfruitsandvegetableswithwax,oil,orresinusedforthepurposeofstorageortransportationiswithinthe“farm”definition.Activitiesthatarewithinthe“farm”definition,whenconductedonafarmmixed‐typefacility,arenotsubjecttotherequirementsofsubpartsCandGofthispartandthereforedonotneedtobespecifiedintheexemption.(2)Thetermsinparagraph(g)(2)ofthissectiondescribecertainfoodsassociatedwiththeactivity/foodcombinationsinparagraph(h)(3)ofthissection.(3)SubpartsCandGofthispartdonotapplytoon‐farmmanufacturing/processingactivitiesconductedbyasmallorverysmallbusinessfordistributionintocommerce,and 117.201doesnotapplytoon‐farmmanufacturing/processingactivitiesconductedbyaverysmallbusinessfordistributionintocommerce,iftheonlymanufacturing/processingactivitiessubjecttosection418oftheFederalFood,Drug,andCosmeticActthatthebusinessconductsarethefollowinglow‐riskmanufacturing/processingactivity/foodcombinations:

(i)Boilinggums,latexes,andresins;(ii)Chopping,coring,cutting,peeling,pitting,shredding,andslicingacidfruitsandvegetablesthathaveapHlessthan4.2(e.g.,cuttinglemonsandlimes),bakedgoods(e.g.,slicingbread),dried/dehydratedfruitandvegetableproducts(e.g.,pittingdriedplums),driedherbsandotherspices(e.g.,choppingintact,driedbasil),gamemeatjerky,gums/latexes/resins,othergrainproducts(e.g.,shreddingdriedcereal),peanutsandtreenuts,andpeanutandtreenutproducts(e.g.,choppingroastedpeanuts);

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(iii)Coatingdried/dehydratedfruitandvegetableproducts(e.g.,coatingraisinswithchocolate),otherfruitandvegetableproductsexceptfornon‐dried,non‐intactfruitsandvegetables(e.g.,coatingdriedplumpieces,driedpittedcherries,anddriedpittedapricotswithchocolatearelow‐riskactivity/foodcombinationsbutcoatingapplesonastickwithcaramelisnotalow‐riskactivity/foodcombination),othergrainproducts(e.g.,addingcarameltopopcornoraddingseasoningstopopcornprovidedthattheseasoningshavebeentreatedtosignificantlyminimizepathogens,peanutsandtreenuts(e.g.,addingseasoningsprovidedthattheseasoningshavebeentreatedtosignificantlyminimizepathogens),andpeanutandtreenutproducts(e.g.,addingseasoningsprovidedthattheseasoningshavebeentreatedtosignificantlyminimizepathogens);(iv)Drying/dehydrating(thatincludesadditionalmanufacturingorisperformedonprocessedfoods)otherfruitandvegetableproductswithpHlessthan4.2(e.g.,dryingcutfruitandvegetableswithpHlessthan4.2),andotherherbandspiceproducts(e.g.,dryingchoppedfreshherbs,includingtea);(v)Extracting(includingbypressing,bydistilling,andbysolventextraction)dried/dehydratedherbandspiceproducts(e.g.,driedmint),freshherbs(e.g.,freshmint),fruitsandvegetables(e.g.,olives,avocados),grains(e.g.,oilseeds),andotherherbandspiceproducts(e.g.,choppedfreshmint,choppeddriedmint);(vi)FreezingacidfruitsandvegetableswithpHlessthan4.2andotherfruitandvegetableproductswithpHlessthan4.2(e.g.,cutfruitsandvegetables);(vii)Grinding/cracking/crushing/millingbakedgoods(e.g.,crackers),cocoabeans(roasted),coffeebeans(roasted),dried/dehydratedfruitandvegetableproducts(e.g.,raisinsanddriedlegumes),dried/dehydratedherbandspiceproducts(e.g.,intactdriedbasil),grains(e.g.,oats,rice,rye,wheat),otherfruitandvegetableproducts(e.g.,dried,pitteddates),othergrainproducts(e.g.,driedcereal),otherherbandspiceproducts(e.g.,choppeddriedherbs),peanutsandtreenuts,andpeanutandtreenutproducts(e.g.,roastedpeanuts);(viii)Labelingbakedgoodsthatdonotcontainfoodallergens,candythatdoesnotcontainfoodallergens,cocoabeans(roasted),cocoaproductsthatdonotcontainfoodallergens),coffeebeans(roasted),gamemeatjerky,gums/latexes/resinsthatareprocessedfoods,honey(pasteurized),jams/jellies/preserves,milledgrainproductsthatdonotcontainfoodallergens(e.g.,cornmeal)orthataresingle‐ingredientfoods(e.g.,wheatflour,wheatbran),molassesandtreacle,oils,otherfruitandvegetableproductsthatdonotcontainfoodallergens(e.g.,snackchipsmadefrompotatoesorplantains),othergrainproductsthatdonotcontainfoodallergens(e.g.,popcorn),otherherbandspiceproducts(e.g.,choppedorgrounddriedherbs),peanutortreenutproducts,(providedthattheyaresingle‐ingredient,orareinformsinwhichtheconsumercanreasonablybeexpectedtorecognizethefoodallergen(s)withoutlabeldeclaration,orboth(e.g.,roastedorseasonedwholenuts,single‐ingredientpeanutortreenutflours)),processedseedsfordirectconsumption,softdrinksandcarbonatedwater,sugar,syrups,trailmixandgranola(otherthanthosecontainingmilkchocolateandprovidedthatpeanutsand/ortreenutsareinformsinwhichtheconsumercanreasonablybeexpectedtorecognizethefoodallergen(s)withoutlabeldeclaration),vinegar,andanyotherprocessedfoodthatdoesnotrequiretime/temperaturecontrolforsafetyandthatdoesnotcontainfoodallergens(e.g.,vitamins,minerals,anddietaryingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform);(ix)Makingbakedgoodsfrommilledgrainproducts(e.g.,breadsandcookies);(x)Makingcandyfrompeanutsandtreenuts(e.g.,nutbrittles),sugar/syrups(e.g.,taffy,toffee),andsaps(e.g.,maplecandy,maplecream);(xi)Makingcocoaproductsfromroastedcocoabeans;(xii)Makingdriedpastafromgrains;(xiii)Makingjams,jellies,andpreservesfromacidfruitsandvegetableswithapHof4.6orbelow;(xiv)Makingmolassesandtreaclefromsugarbeetsandsugarcane;(xv)Makingoatflakesfromgrains;(xvi)Makingpopcornfromgrains;(xvii)Makingsnackchipsfromfruitsandvegetables(e.g.,makingplantainandpotatochips);(xviii)Makingsoftdrinksandcarbonatedwaterfromsugar,syrups,andwater;(xix)Makingsugarsandsyrupsfromfruitsandvegetables(e.g.,dates),grains(e.g.,rice,sorghum),othergrainproducts(e.g.,maltedgrainssuchasbarley),saps(e.g.,agave,birch,maple,palm),sugarbeets,andsugarcane;(xx)Makingtrailmixandgranolafromcocoaproducts(e.g.,chocolate),dried/dehydratedfruitandvegetableproducts(e.g.,raisins),otherfruitandvegetableproducts(e.g.,choppeddriedfruits),othergrainproducts(e.g.,oatflakes),peanutandtreenutproducts,andprocessedseedsfordirectconsumption,providedthatpeanuts,treenuts,andprocessedseedsaretreatedtosignificantlyminimizepathogens;(xxi)Makingvinegarfromfruitsandvegetables,otherfruitandvegetableproducts(e.g.,fruitwines,applecider),andothergrainproducts(e.g.,malt);(xxii)Mixingbakedgoods(e.g.,typesofcookies),candy(e.g.,varietiesoftaffy),cocoabeans(roasted),coffeebeans(roasted),dried/dehydratedfruitandvegetableproducts(e.g.,driedblueberries,driedcurrants,andraisins),dried/dehydratedherbandspiceproducts(e.g.,dried,intactbasilanddried,intactoregano),honey(pasteurized),milledgrainproducts(e.g.,flour,bran,andcornmeal),otherfruitandvegetableproducts(e.g.,

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dried,slicedapplesanddried,slicedpeaches),othergrainproducts(e.g.,differenttypesofdriedpasta),otherherbandspiceproducts(e.g.,choppedorgrounddriedherbs,driedherb‐orspice‐infusedhoney,anddriedherb‐orspice‐infusedoilsand/orvinegars),peanutandtreenutproducts,sugar,syrups,vinegar,andanyotherprocessedfoodthatdoesnotrequiretime/temperaturecontrolforsafety(e.g.,vitamins,minerals,anddietaryingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform);(xxiii)Packagingbakedgoods(e.g.,breadandcookies),candy,cocoabeans(roasted),cocoaproducts,coffeebeans(roasted),gamemeatjerky,gums/latexes/resinsthatareprocessedfoods,honey(pasteurized),jams/jellies/preserves,milledgrainproducts(e.g.,flour,bran,cornmeal),molassesandtreacle,oils,otherfruitandvegetableproducts(e.g.,pitted,driedfruits;sliced,driedapples;snackchips),othergrainproducts(e.g.,popcorn),otherherbandspiceproducts(e.g.,choppedorgrounddriedherbs),peanutandtreenutproducts,processedseedsfordirectconsumption,softdrinksandcarbonatedwater,sugar,syrups,trailmixandgranola,vinegar,andanyotherprocessedfoodthatdoesnotrequiretime/temperaturecontrolforsafety(e.g.,vitamins,minerals,anddietaryingredients(e.g.,bonemeal)inpowdered,granular,orothersolidform);(xxiv)Pasteurizinghoney;(xxv)Roastingandtoastingbakedgoods(e.g.,toastingbreadforcroutons);(xxvi)Saltingothergrainproducts(e.g.,soynuts),peanutandtreenutproducts,andprocessedseedsfordirectconsumption;and(xxvii)Siftingmilledgrainproducts(e.g.,flour,bran,cornmeal),otherfruitandvegetableproducts(e.g.,chickpeaflour),andpeanutandtreenutproducts(e.g.,peanutflour,almondflour).

(i)(1)SubpartsCandGofthispartdonotapplywithrespecttoalcoholicbeveragesatafacilitythatmeetsthefollowingtwoconditions:

(i)UndertheFederalAlcoholAdministrationAct(27U.S.C.201etseq.)orchapter51ofsubtitleEoftheInternalRevenueCodeof1 86(26U.S.C.5001etseq.)thefacilityisrequiredtoobtainapermitfrom,registerwith,orobtainapprovalofanoticeorapplicationfromtheSecretaryoftheTreasuryasaconditionofdoingbusinessintheUnitedStates,orisaforeignfacilityofatypethatwouldrequiresuchapermit,registration,orapprovalifitwereadomesticfacility;and(ii)Undersection415oftheFederalFood,Drug,andCosmeticActthefacilityisrequiredtoregisterasafacilitybecauseitisengagedinmanufacturing,processing,packing,orholdingoneormorealcoholicbeverages.

(2)SubpartsCandGofthispartdonotapplywithrespecttofoodthatisnotanalcoholicbeverageatafacilitydescribedinparagraph(i)(1)ofthissection,providedsuchfood:

(i)Isinprepackagedformthatpreventsanydirecthumancontactwithsuchfood;and(ii)Constitutesnotmorethan5percentoftheoverallsalesofthefacility,asdeterminedbytheSecretaryoftheTreasury.

(j)SubpartsCandGofthispartdonotapplytofacilitiesthataresolelyengagedinthestorageofrawagriculturalcommodities(otherthanfruitsandvegetables)intendedforfurtherdistributionorprocessing.(k)(1)Exceptasprovidedbyparagraph(k)(2)ofthissection,subpartBofthispartdoesnotapplytoanyofthefollowing:

(i)“Farms”(asdefinedin 1.227ofthischapter);(ii)Fishingvesselsthatarenotsubjecttotheregistrationrequirementsofpart1,subpartHofthischapterinaccordancewith 1.226(f)ofthischapter;(iii)Establishmentssolelyengagedintheholdingand/ortransportationofoneormorerawagriculturalcommodities;(iv)Activitiesof“farmmixed‐typefacilities”(asdefinedin 1.227ofthischapter)thatfallwithinthedefinitionof“farm”;or(v)Establishmentssolelyengagedinhulling,shelling,drying,packing,and/orholdingnuts(withoutadditionalmanufacturing/processing,suchasroastingnuts).

(2)Ifa“farm”or“farmmixed‐typefacility”dries/dehydratesrawagriculturalcommoditiesthatareproduceasdefinedinpart112ofthischaptertocreateadistinctcommodity,subpartBofthispartappliestothepackaging,packing,andholdingofthedriedcommodities.CompliancewiththisrequirementmaybeachievedbycomplyingwithsubpartBofthispartorwiththeapplicablerequirementsforpackingandholdinginpart112ofthischapter.

§ 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food. (a)ApplicabilityofsubpartsCandG.SubpartsCandGofthispartdonotapplytoafacilitysolelyengagedinthestorageofunexposedpackagedfood.(b)ApplicabilityofsubpartD.Afacilitysolelyengagedinthestorageofunexposedpackagedfood,includingunexposedpackagedfoodthatrequirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogensissubjecttothemodifiedrequirementsin 117.206foranyunexposedpackagedfoodthatrequirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogens.

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§ 117.8 Applicability of subpart B of this part to the off‐farm packing and holding of raw agricultural commodities. Exceptasprovidedby 117.5(k)(1),subpartBofthispartappliestotheoff‐farmpackaging,packing,andholdingofrawagriculturalcommodities.Compliancewiththisrequirementforrawagriculturalcommoditiesthatareproduceasdefinedinpart112ofthischaptermaybeachievedbycomplyingwithsubpartBofthispartorwiththeapplicablerequirementsforpackingandholdinginpart112ofthischapter.§ 117.9 Records required for this subpart. (a)Recordsthatdocumenttrainingrequiredby 117.4(b)(2)mustbeestablishedandmaintained.(b)TherecordsthatmustbeestablishedandmaintainedaresubjecttotherequirementsofsubpartFofthispart.

Subpart B – Current Good Manufacturing Practice § 117.10 Personnel. Themanagementoftheestablishmentmusttakereasonablemeasuresandprecautionstoensurethefollowing:(a)Diseasecontrol.Anypersonwho,bymedicalexaminationorsupervisoryobservation,isshowntohave,orappearstohave,anillness,openlesion,includingboils,sores,orinfectedwounds,oranyotherabnormalsourceofmicrobialcontaminationbywhichthereisareasonablepossibilityoffood,food‐contactsurfaces,orfood‐packagingmaterialsbecomingcontaminated,mustbeexcludedfromanyoperationswhichmaybeexpectedtoresultinsuchcontaminationuntiltheconditioniscorrected,unlessconditionssuchasopenlesions,boils,andinfectedwoundsareadequatelycovered(e.g.,byanimpermeablecover).Personnelmustbeinstructedtoreportsuchhealthconditionstotheirsupervisors.(b)Cleanliness.Allpersonsworkingindirectcontactwithfood,food‐contactsurfaces,andfood‐packagingmaterialsmustconformtohygienicpracticeswhileondutytotheextentnecessarytoprotectagainstallergencross‐contactandagainstcontaminationoffood.Themethodsformaintainingcleanlinessinclude:

(1)Wearingoutergarmentssuitabletotheoperationinamannerthatprotectsagainstallergencross‐contactandagainstthecontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials.(2)Maintainingadequatepersonalcleanliness.(3)Washinghandsthoroughly(andsanitizingifnecessarytoprotectagainstcontaminationwithundesirablemicroorganisms)inanadequatehand‐washingfacilitybeforestartingwork,aftereachabsencefromtheworkstation,andatanyothertimewhenthehandsmayhavebecomesoiledorcontaminated.(4)Removingallunsecuredjewelryandotherobjectsthatmightfallintofood,equipment,orcontainers,andremovinghandjewelrythatcannotbeadequatelysanitizedduringperiodsinwhichfoodismanipulatedbyhand.Ifsuchhandjewelrycannotberemoved,itmaybecoveredbymaterialwhichcanbemaintainedinanintact,clean,andsanitaryconditionandwhicheffectivelyprotectsagainstthecontaminationbytheseobjectsofthefood,food‐contactsurfaces,orfood‐packagingmaterials.(5)Maintaininggloves,iftheyareusedinfoodhandling,inanintact,clean,andsanitarycondition.(6)Wearing,whereappropriate,inaneffectivemanner,hairnets,headbands,caps,beardcovers,orothereffectivehairrestraints.(7)Storingclothingorotherpersonalbelongingsinareasotherthanwherefoodisexposedorwhereequipmentorutensilsarewashed.(8)Confiningthefollowingtoareasotherthanwherefoodmaybeexposedorwhereequipmentorutensilsarewashed:eatingfood,chewinggum,drinkingbeverages,orusingtobacco.( )Takinganyothernecessaryprecautionstoprotectagainstallergencross‐contactandagainstcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterialswithmicroorganismsorforeignsubstances(includingperspiration,hair,cosmetics,tobacco,chemicals,andmedicinesappliedtotheskin).

§ 117.20 Plant and grounds. (a)Grounds.Thegroundsaboutafoodplantunderthecontroloftheoperatormustbekeptinaconditionthatwillprotectagainstthecontaminationoffood.Themethodsforadequatemaintenanceofgroundsmustinclude:

(1)Properlystoringequipment,removinglitterandwaste,andcuttingweedsorgrasswithintheimmediatevicinityoftheplantthatmayconstituteanattractant,breedingplace,orharborageforpests.(2)Maintainingroads,yards,andparkinglotssothattheydonotconstituteasourceofcontaminationinareaswherefoodisexposed.(3)Adequatelydrainingareasthatmaycontributecontaminationtofoodbyseepage,foot‐bornefilth,orprovidingabreedingplaceforpests.(4)Operatingsystemsforwastetreatmentanddisposalinanadequatemannersothattheydonotconstituteasourceofcontaminationinareaswherefoodisexposed.(5)Iftheplantgroundsareborderedbygroundsnotundertheoperator’scontrolandnotmaintainedinthemannerdescribedinparagraphs(a)(1)through(4)ofthissection,caremustbeexercisedintheplantbyinspection,extermination,orothermeanstoexcludepests,dirt,andfilththatmaybeasourceoffoodcontamination.

(b)Plantconstructionanddesign.Theplantmustbesuitableinsize,construction,anddesigntofacilitatemaintenanceandsanitaryoperationsforfood‐productionpurposes(i.e.,manufacturing,processing,packing,andholding).Theplantmust:

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(1)Provideadequatespaceforsuchplacementofequipmentandstorageofmaterialsasisnecessaryformaintenance,sanitaryoperations,andtheproductionofsafefood.(2)Permitthetakingofadequateprecautionstoreducethepotentialforallergencross‐contactandforcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterialswithmicroorganisms,chemicals,filth,andotherextraneousmaterial.Thepotentialforallergencross‐contactandforcontaminationmaybereducedbyadequatefoodsafetycontrolsandoperatingpracticesoreffectivedesign,includingtheseparationofoperationsinwhichallergencross‐contactandcontaminationarelikelytooccur,byoneormoreofthefollowingmeans:location,time,partition,airflowsystems,dustcontrolsystems,enclosedsystems,orothereffectivemeans.(3)Permitthetakingofadequateprecautionstoprotectfoodininstalledoutdoorbulkvesselsbyanyeffectivemeans,including:

(i)Usingprotectivecoverings.(ii)Controllingareasoverandaroundthevesselstoeliminateharboragesforpests.(iii)Checkingonaregularbasisforpestsandpestinfestation.(iv)Skimmingfermentationvessels,asnecessary.

(4)Beconstructedinsuchamannerthatfloors,walls,andceilingsmaybeadequatelycleanedandkeptcleanandkeptingoodrepair;thatdriporcondensatefromfixtures,ductsandpipesdoesnotcontaminatefood,food‐contactsurfaces,orfood‐packagingmaterials;andthataislesorworkingspacesareprovidedbetweenequipmentandwallsandareadequatelyunobstructedandofadequatewidthtopermitemployeestoperformtheirdutiesandtoprotectagainstcontaminatingfood,food‐contactsurfaces,orfood‐packagingmaterialswithclothingorpersonalcontact.(5)Provideadequatelightinginhand‐washingareas,dressingandlockerrooms,andtoiletroomsandinallareaswherefoodisexamined,manufactured,processed,packed,orheldandwhereequipmentorutensilsarecleaned;andprovideshatter‐resistantlightbulbs,fixtures,skylights,orotherglasssuspendedoverexposedfoodinanystepofpreparationorotherwiseprotectagainstfoodcontaminationincaseofglassbreakage.(6)Provideadequateventilationorcontrolequipmenttominimizedust,odorsandvapors(includingsteamandnoxiousfumes)inareaswheretheymaycauseallergencross‐contactorcontaminatefood;andlocateandoperatefansandotherair‐blowingequipmentinamannerthatminimizesthepotentialforallergencross‐contactandforcontaminatingfood,food‐packagingmaterials,andfood‐contactsurfaces.(7)Provide,wherenecessary,adequatescreeningorotherprotectionagainstpests.

§ 117.35 Sanitary operations. (a)Generalmaintenance.Buildings,fixtures,andotherphysicalfacilitiesoftheplantmustbemaintainedinacleanandsanitaryconditionandmustbekeptinrepairadequatetopreventfoodfrombecomingadulterated.Cleaningandsanitizingofutensilsandequipmentmustbeconductedinamannerthatprotectsagainstallergencross‐contactandagainstcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials.(b)Substancesusedincleaningandsanitizing;storageoftoxicmaterials.

(1)Cleaningcompoundsandsanitizingagentsusedincleaningandsanitizingproceduresmustbefreefromundesirablemicroorganismsandmustbesafeandadequateundertheconditionsofuse.Compliancewiththisrequirementmustbeverifiedbyanyeffectivemeans,includingpurchaseofthesesubstancesunderaletterofguaranteeorcertificationorexaminationofthesesubstancesforcontamination.Onlythefollowingtoxicmaterialsmaybeusedorstoredinaplantwherefoodisprocessedorexposed:

(i)Thoserequiredtomaintaincleanandsanitaryconditions;(ii)Thosenecessaryforuseinlaboratorytestingprocedures;(iii)Thosenecessaryforplantandequipmentmaintenanceandoperation;and(iv)Thosenecessaryforuseintheplant’soperations.

(2)Toxiccleaningcompounds,sanitizingagents,andpesticidechemicalsmustbeidentified,held,andstoredinamannerthatprotectsagainstcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials.

(c)Pestcontrol.Pestsmustnotbeallowedinanyareaofafoodplant.Guard,guide,orpest‐detectingdogsmaybeallowedinsomeareasofaplantifthepresenceofthedogsisunlikelytoresultincontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials.Effectivemeasuresmustbetakentoexcludepestsfromthemanufacturing,processing,packing,andholdingareasandtoprotectagainstthecontaminationoffoodonthepremisesbypests.Theuseofpesticidestocontrolpestsintheplantispermittedonlyunderprecautionsandrestrictionsthatwillprotectagainstthecontaminationoffood,food‐contactsurfaces,andfood‐packagingmaterials.(d)Sanitationoffood‐contactsurfaces.Allfood‐contactsurfaces,includingutensilsandfood‐contactsurfacesofequipment,mustbecleanedasfrequentlyasnecessarytoprotectagainstallergencross‐contactandagainstcontaminationoffood.

(1)Food‐contactsurfacesusedformanufacturing/processing,packing,orholdinglow‐moisturefoodmustbeinaclean,dry,sanitaryconditionbeforeuse.Whenthesurfacesarewet‐cleaned,theymust,whennecessary,besanitizedandthoroughlydriedbeforesubsequentuse.(2)Inwetprocessing,whencleaningisnecessarytoprotectagainstallergencross‐contactortheintroductionofmicroorganismsintofood,allfood‐contactsurfacesmustbecleanedandsanitizedbeforeuseandafterany

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interruptionduringwhichthefood‐contactsurfacesmayhavebecomecontaminated.Whereequipmentandutensilsareusedinacontinuousproductionoperation,theutensilsandfood‐contactsurfacesoftheequipmentmustbecleanedandsanitizedasnecessary.(3)Single‐servicearticles(suchasutensilsintendedforone‐timeuse,papercups,andpapertowels)mustbestored,handled,anddisposedofinamannerthatprotectsagainstallergencross‐contactandagainstcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials.

(e)Sanitationofnon‐food‐contactsurfaces.Non‐food‐contactsurfacesofequipmentusedintheoperationofafoodplantmustbecleanedinamannerandasfrequentlyasnecessarytoprotectagainstallergencross‐contactandagainstcontaminationoffood,food‐contactsurfaces,andfood‐packagingmaterials.(f)Storageandhandlingofcleanedportableequipmentandutensils.Cleanedandsanitizedportableequipmentwithfood‐contactsurfacesandutensilsmustbestoredinalocationandmannerthatprotectsfood‐contactsurfacesfromallergencross‐contactandfromcontamination.§ 117.37 Sanitary facilities and controls. Eachplantmustbeequippedwithadequatesanitaryfacilitiesandaccommodationsincluding:(a)Watersupply.Thewatersupplymustbeadequatefortheoperationsintendedandmustbederivedfromanadequatesource.Anywaterthatcontactsfood,food‐contactsurfaces,orfood‐packagingmaterialsmustbesafeandofadequatesanitaryquality.Runningwateratasuitabletemperature,andunderpressureasneeded,mustbeprovidedinallareaswhererequiredfortheprocessingoffood,forthecleaningofequipment,utensils,andfood‐packagingmaterials,orforemployeesanitaryfacilities.(b)Plumbing.Plumbingmustbeofadequatesizeanddesignandadequatelyinstalledandmaintainedto:

(1)Carryadequatequantitiesofwatertorequiredlocationsthroughouttheplant.(2)Properlyconveysewageandliquiddisposablewastefromtheplant.(3)Avoidconstitutingasourceofcontaminationtofood,watersupplies,equipment,orutensilsorcreatinganunsanitarycondition.(4)Provideadequatefloordrainageinallareaswherefloorsaresubjecttoflooding‐typecleaningorwherenormaloperationsreleaseordischargewaterorotherliquidwasteonthefloor.(5)Providethatthereisnotbackflowfrom,orcross‐connectionbetween,pipingsystemsthatdischargewastewaterorsewageandpipingsystemsthatcarrywaterforfoodorfoodmanufacturing.

(c)Sewagedisposal.Sewagemustbedisposedofintoanadequateseweragesystemordisposedofthroughotheradequatemeans.(d)Toiletfacilities.Eachplantmustprovideemployeeswithadequate,readilyaccessibletoiletfacilities.Toiletfacilitiesmustbekeptcleanandmustnotbeapotentialsourceofcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials.(e)Hand‐washingfacilities.Eachplantmustprovidehand‐washingfacilitiesdesignedtoensurethatanemployee’shandsarenotasourceofcontaminationoffood,food‐contactsurfaces,orfood‐packagingmaterials,byprovidingfacilitiesthatareadequate,convenient,andfurnishrunningwateratasuitabletemperature.(f)Rubbishandoffaldisposal.Rubbishandanyoffalmustbesoconveyed,stored,anddisposedofastominimizethedevelopmentofodor,minimizethepotentialforthewastebecominganattractantandharborageorbreedingplaceforpests,andprotectagainstcontaminationoffood,food‐contactsurfaces,food‐packagingmaterials,watersupplies,andgroundsurfaces.§ 117.40 Equipment and utensils. (a)(1)Allplantequipmentandutensilsusedinmanufacturing,processing,packing,orholdingfoodmustbesodesigned

andofsuchmaterialandworkmanshipastobeadequatelycleanable,andmustbeadequatelymaintainedtoprotectagainstallergencross‐contactandcontamination.(2)Equipmentandutensilsmustbedesigned,constructed,andusedappropriatelytoavoidtheadulterationoffoodwithlubricants,fuel,metalfragments,contaminatedwater,oranyothercontaminants.(3)Equipmentmustbeinstalledsoastofacilitatethecleaningandmaintenanceoftheequipmentandofadjacentspaces.(4)Food‐contactsurfacesmustbecorrosion‐resistantwhenincontactwithfood.(5)Food‐contactsurfacesmustbemadeofnontoxicmaterialsanddesignedtowithstandtheenvironmentoftheirintendeduseandtheactionoffood,and,ifapplicable,cleaningcompounds,sanitizingagents,andcleaningprocedures.(6)Food‐contactsurfacesmustbemaintainedtoprotectfoodfromallergencross‐contactandfrombeingcontaminatedbyanysource,includingunlawfulindirectfoodadditives.

(b)Seamsonfood‐contactsurfacesmustbesmoothlybondedormaintainedsoastominimizeaccumulationoffoodparticles,dirt,andorganicmatterandthusminimizetheopportunityforgrowthofmicroorganismsandallergencross‐contact.(c)Equipmentthatisinareaswherefoodismanufactured,processed,packed,orheldandthatdoesnotcomeintocontactwithfoodmustbesoconstructedthatitcanbekeptinacleanandsanitarycondition.

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(d)Holding,conveying,andmanufacturingsystems,includinggravimetric,pneumatic,closed,andautomatedsystems,mustbeofadesignandconstructionthatenablesthemtobemaintainedinanappropriatecleanandsanitarycondition.(e)Eachfreezerandcoldstoragecompartmentusedtostoreandholdfoodcapableofsupportinggrowthofmicroorganismsmustbefittedwithanindicatingthermometer,temperature‐measuringdevice,ortemperature‐recordingdevicesoinstalledastoshowthetemperatureaccuratelywithinthecompartment.(f)Instrumentsandcontrolsusedformeasuring,regulating,orrecordingtemperatures,pH,acidity,wateractivity,orotherconditionsthatcontrolorpreventthegrowthofundesirablemicroorganismsinfoodmustbeaccurateandpreciseandadequatelymaintained,andadequateinnumberfortheirdesignateduses.(g)Compressedairorothergasesmechanicallyintroducedintofoodorusedtocleanfood‐contactsurfacesorequipmentmustbetreatedinsuchawaythatfoodisnotcontaminatedwithunlawfulindirectfoodadditives.§ 117.80 Processes and controls. (a)General.(1)Alloperationsinthemanufacturing,processing,packing,andholdingoffood(includingoperations

directedtoreceiving,inspecting,transporting,andsegregating)mustbeconductedinaccordancewithadequatesanitationprinciples.(2)Appropriatequalitycontroloperationsmustbeemployedtoensurethatfoodissuitableforhumanconsumptionandthatfood‐packagingmaterialsaresafeandsuitable.(3)Overallsanitationoftheplantmustbeunderthesupervisionofoneormorecompetentindividualsassignedresponsibilityforthisfunction.(4)Adequateprecautionsmustbetakentoensurethatproductionproceduresdonotcontributetoallergencross‐contactandtocontaminationfromanysource.(5)Chemical,microbial,orextraneous‐materialtestingproceduresmustbeusedwherenecessarytoidentifysanitationfailuresorpossibleallergencross‐contactandfoodcontamination.(6)Allfoodthathasbecomecontaminatedtotheextentthatitisadulteratedmustberejected,orifappropriate,treatedorprocessedtoeliminatethecontamination.

(b)Rawmaterialsandotheringredients.(1)Rawmaterialsandotheringredientsmustbeinspectedandsegregatedorotherwisehandledasnecessarytoascertainthattheyarecleanandsuitableforprocessingintofoodandmustbestoredunderconditionsthatwillprotectagainstallergencross‐contactandagainstcontaminationandminimizedeterioration.Rawmaterialsmustbewashedorcleanedasnecessarytoremovesoilorothercontamination.Waterusedforwashing,rinsing,orconveyingfoodmustbesafeandofadequatesanitaryquality.Watermaybereusedforwashing,rinsing,orconveyingfoodifitdoesnotcauseallergencross‐contactorincreasethelevelofcontaminationofthefood.(2)Rawmaterialsandotheringredientsmusteithernotcontainlevelsofmicroorganismsthatmayrenderthefoodinjurioustothehealthofhumans,ortheymustbepasteurizedorotherwisetreatedduringmanufacturingoperationssothattheynolongercontainlevelsthatwouldcausetheproducttobeadulterated.(3)RawmaterialsandotheringredientssusceptibletocontaminationwithaflatoxinorothernaturaltoxinsmustcomplywithFDAregulationsforpoisonousordeleterioussubstancesbeforetheserawmaterialsorotheringredientsareincorporatedintofinishedfood.(4)Rawmaterials,otheringredients,andreworksusceptibletocontaminationwithpests,undesirablemicroorganisms,orextraneousmaterialmustcomplywithapplicableFDAregulationsfornaturalorunavoidabledefectsifamanufacturerwishestousethematerialsinmanufacturingfood.(5)Rawmaterials,otheringredients,andreworkmustbeheldinbulk,orincontainersdesignedandconstructedsoastoprotectagainstallergencross‐contactandagainstcontaminationandmustbeheldatsuchtemperatureandrelativehumidityandinsuchamannerastopreventthefoodfrombecomingadulterated.Materialscheduledforreworkmustbeidentifiedassuch.(6)Frozenrawmaterialsandotheringredientsmustbekeptfrozen.Ifthawingisrequiredpriortouse,itmustbedoneinamannerthatpreventstherawmaterialsandotheringredientsfrombecomingadulterated.(7)Liquidordryrawmaterialsandotheringredientsreceivedandstoredinbulkformmustbeheldinamannerthatprotectsagainstallergencross‐contactandagainstcontamination.(8)Rawmaterialsandotheringredientsthatarefoodallergens,andreworkthatcontainsfoodallergens,mustbeidentifiedandheldinamannerthatpreventsallergencross‐contact.

(c)Manufacturingoperations.(1)Equipmentandutensilsandfoodcontainersmustbemaintainedinanadequateconditionthroughappropriatecleaningandsanitizing,asnecessary.Insofarasnecessary,equipmentmustbetakenapartforthoroughcleaning.(2)Allfoodmanufacturing,processing,packing,andholdingmustbeconductedundersuchconditionsandcontrolsasarenecessarytominimizethepotentialforthegrowthofmicroorganisms,allergencross‐contact,contaminationoffood,anddeteriorationoffood.(3)Foodthatcansupporttherapidgrowthofundesirablemicroorganismsmustbeheldattemperaturesthatwillpreventthefoodfrombecomingadulteratedduringmanufacturing,processing,packing,andholding.

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(4)Measuressuchassterilizing,irradiating,pasteurizing,cooking,freezing,refrigerating,controllingpH,orcontrollingawthataretakentodestroyorpreventthegrowthofundesirablemicroorganismsmustbeadequateundertheconditionsofmanufacture,handling,anddistributiontopreventfoodfrombeingadulterated.(5)Work‐in‐processandreworkmustbehandledinamannerthatprotectsagainstallergencross‐contact,contamination,andgrowthofundesirablemicroorganisms.(6)Effectivemeasuresmustbetakentoprotectfinishedfoodfromallergencross‐contactandfromcontaminationbyrawmaterials,otheringredients,orrefuse.Whenrawmaterials,otheringredients,orrefuseareunprotected,theymustnotbehandledsimultaneouslyinareceiving,loading,orshippingareaifthathandlingcouldresultinallergencross‐contactorcontaminatedfood.Foodtransportedbyconveyormustbeprotectedagainstallergencross‐contactandagainstcontaminationasnecessary.(7)Equipment,containers,andutensilsusedtoconvey,hold,orstorerawmaterialsandotheringredients,work‐in‐process,rework,orotherfoodmustbeconstructed,handled,andmaintainedduringmanufacturing,processing,packing,andholdinginamannerthatprotectsagainstallergencross‐contactandagainstcontamination.(8)Adequatemeasuresmustbetakentoprotectagainsttheinclusionofmetalorotherextraneousmaterialinfood.( )Food,rawmaterials,andotheringredientsthatareadulterated:

(i)Mustbedisposedofinamannerthatprotectsagainstthecontaminationofotherfood;or(ii)Iftheadulteratedfoodiscapableofbeingreconditioned,itmustbe:

(A)Reconditioned(ifappropriate)usingamethodthathasbeenproventobeeffective;or(B)Reconditioned(ifappropriate)andreexaminedandsubsequentlyfoundnottobeadulteratedwithinthemeaningoftheFederalFood,Drug,andCosmeticActbeforebeingincorporatedintootherfood.

(10)Stepssuchaswashing,peeling,trimming,cutting,sortingandinspecting,mashing,dewatering,cooling,shredding,extruding,drying,whipping,defatting,andformingmustbeperformedsoastoprotectfoodagainstallergencross‐contactandagainstcontamination.Foodmustbeprotectedfromcontaminantsthatmaydrip,drain,orbedrawnintothefood.(11)Heatblanching,whenrequiredinthepreparationoffoodcapableofsupportingmicrobialgrowth,mustbeeffectedbyheatingthefoodtotherequiredtemperature,holdingitatthistemperaturefortherequiredtime,andtheneitherrapidlycoolingthefoodorpassingittosubsequentmanufacturingwithoutdelay.Growthandcontaminationbythermophilicmicroorganismsinblanchersmustbeminimizedbytheuseofadequateoperatingtemperaturesandbyperiodiccleaningandsanitizingasnecessary.(12)Batters,breading,sauces,gravies,dressings,dippingsolutions,andothersimilarpreparationsthatareheldandusedrepeatedlyovertimemustbetreatedormaintainedinsuchamannerthattheyareprotectedagainstallergencross‐contactandagainstcontamination,andminimizingthepotentialforthegrowthofundesirablemicroorganisms.(13)Filling,assembling,packaging,andotheroperationsmustbeperformedinsuchawaythatthefoodisprotectedagainstallergencross‐contact,contaminationandgrowthofundesirablemicroorganisms.(14)Food,suchasdrymixes,nuts,intermediatemoisturefood,anddehydratedfood,thatreliesprincipallyonthecontrolofawforpreventingthegrowthofundesirablemicroorganismsmustbeprocessedtoandmaintainedatasafemoisturelevel.(15)Food,suchasacidandacidifiedfood,thatreliesprincipallyonthecontrolofpHforpreventingthegrowthofundesirablemicroorganismsmustbemonitoredandmaintainedatapHof4.6orbelow.(16)Wheniceisusedincontactwithfood,itmustbemadefromwaterthatissafeandofadequatesanitaryqualityinaccordancewith 117.37(a),andmustbeusedonlyifithasbeenmanufacturedinaccordancewithcurrentgoodmanufacturingpracticeasoutlinedinthispart.

§ 117.93 Warehousing and distribution. Storageandtransportationoffoodmustbeunderconditionsthatwillprotectagainstallergencross‐contactandagainstbiological,chemical(includingradiological),andphysicalcontaminationoffood,aswellasagainstdeteriorationofthefoodandthecontainer.§ 117.95 Holding and distribution of human food by‐products for use as animal food. (a)Humanfoodby‐productsheldfordistributionasanimalfoodwithoutadditionalmanufacturingorprocessingbythehumanfoodprocessor,asidentifiedin 507.12ofthischapter,mustbeheldunderconditionsthatwillprotectagainstcontamination,includingthefollowing:

(1)Containersandequipmentusedtoconveyorholdhumanfoodby‐productsforuseasanimalfoodbeforedistributionmustbedesigned,constructedofappropriatematerial,cleanedasnecessary,andmaintainedtoprotectagainstthecontaminationofhumanfoodby‐productsforuseasanimalfood;(2)Humanfoodby‐productsforuseasanimalfoodheldfordistributionmustbeheldinawaytoprotectagainstcontaminationfromsourcessuchastrash;and(3)Duringholding,humanfoodby‐productsforuseasanimalfoodmustbeaccuratelyidentified.

(b)Labelingthatidentifiestheby‐productbythecommonorusualnamemustbeaffixedtooraccompanyhumanfoodby‐productsforuseasanimalfoodwhendistributed.

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(c)Shippingcontainers(e.g.,totes,drums,andtubs)andbulkvehiclesusedtodistributehumanfoodby‐productsforuseasanimalfoodmustbeexaminedpriortousetoprotectagainstcontaminationofthehumanfoodby‐productsforuseasanimalfoodfromthecontainerorvehiclewhenthefacilityisresponsiblefortransportingthehumanfoodby‐productsforuseasanimalfooditselforarrangeswithathirdpartytotransportthehumanfoodby‐productsforuseasanimalfood.§ 117.110 Defect action levels. (a)Themanufacturer,processor,packer,andholderoffoodmustatalltimesutilizequalitycontroloperationsthatreducenaturalorunavoidabledefectstothelowestlevelcurrentlyfeasible.(b)Themixingofafoodcontainingdefectsatlevelsthatrenderthatfoodadulteratedwithanotherlotoffoodisnotpermittedandrendersthefinalfoodadulterated,regardlessofthedefectlevelofthefinalfood.Forexamplesofdefectactionlevelsthatmayrenderfoodadulterated,seetheDefectLevelsHandbook,whichisaccessibleathttp://www.fda.gov/pchfruleandathttp://www.fda.gov.

Subpart C– Hazard Analysis and Risk‐Based Preventive Controls § 117.126 Food safety plan. (a)Requirementforafoodsafetyplan.

(1) oumustprepare,orhaveprepared,andimplementawrittenfoodsafetyplan.(2)Thefoodsafetyplanmustbeprepared,oritspreparationoverseen,byoneormorepreventivecontrolsqualifiedindividuals.

(b)Contentsofafoodsafetyplan.Thewrittenfoodsafetyplanmustinclude:(1)Thewrittenhazardanalysisasrequiredby 117.130(a)(2);(2)Thewrittenpreventivecontrolsasrequiredby 117.135(b);(3)Thewrittensupply‐chainprogramasrequiredbysubpartGofthispart;(4)Thewrittenrecallplanasrequiredby 117.13 (a);and(5)Thewrittenproceduresformonitoringtheimplementationofthepreventivecontrolsasrequiredby 117.145(a)(1);(6)Thewrittencorrectiveactionproceduresasrequiredby 117.150(a)(1);and(7)Thewrittenverificationproceduresasrequiredby 117.165(b).

(c)Records.ThefoodsafetyplanrequiredbythissectionisarecordthatissubjecttotherequirementsofsubpartFofthispart.§ 117.130 Hazard analysis. (a)Requirementforahazardanalysis.

(1) oumustconductahazardanalysistoidentifyandevaluate,basedonexperience,illnessdata,scientificreports,andotherinformation,knownorreasonablyforeseeablehazardsforeachtypeoffoodmanufactured,processed,packed,orheldatyourfacilitytodeterminewhetherthereareanyhazardsrequiringapreventivecontrol.(2)Thehazardanalysismustbewrittenregardlessofitsoutcome.

(b)Hazardidentification.Thehazardidentificationmustconsider:(1)Knownorreasonablyforeseeablehazardsthatinclude:

(i)Biologicalhazards,includingmicrobiologicalhazardssuchasparasites,environmentalpathogens,andotherpathogens;(ii)Chemicalhazards,includingradiologicalhazards,substancessuchaspesticideanddrugresidues,naturaltoxins,decomposition,unapprovedfoodorcoloradditives,andfoodallergens;and(iii)Physicalhazards(suchasstones,glass,andmetalfragments);and

(2)Knownorreasonablyforeseeablehazardsthatmaybepresentinthefoodforanyofthefollowingreasons:(i)Thehazardoccursnaturally;(ii)Thehazardmaybeunintentionallyintroduced;or(iii)Thehazardmaybeintentionallyintroducedforpurposesofeconomicgain.

(c)Hazardevaluation.(1)(i)Thehazardanalysismustincludeanevaluationofthehazardsidentifiedinparagraph(b)ofthissectiontoassesstheseverityoftheillnessorinjuryifthehazardweretooccurandtheprobabilitythatthehazardwilloccurintheabsenceofpreventivecontrols.

(ii)Thehazardevaluationrequiredbyparagraph(c)(1)(i)ofthissectionmustincludeanevaluationofenvironmentalpathogenswheneveraready‐to‐eatfoodisexposedtotheenvironmentpriortopackagingandthepackagedfooddoesnotreceiveatreatmentorotherwiseincludeacontrolmeasure(suchasaformulationlethaltothepathogen)thatwouldsignificantlyminimizethepathogen.

(2)Thehazardevaluationmustconsidertheeffectofthefollowingonthesafetyofthefinishedfoodfortheintendedconsumer:

(i)Theformulationofthefood;(ii)Thecondition,function,anddesignofthefacilityandequipment;

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(iii)Rawmaterialsandotheringredients;(iv)Transportationpractices;(v)Manufacturing/processingprocedures;(vi)Packagingactivitiesandlabelingactivities;(vii)Storageanddistribution;(viii)Intendedorreasonablyforeseeableuse;(ix)Sanitation,includingemployeehygiene;and(x)Anyotherrelevantfactors,suchasthetemporal(e.g.,weather‐related)natureofsomehazards(e.g.,levelsofsomenaturaltoxins).

§ 117.135 Preventive controls. (a)(1) oumustidentifyandimplementpreventivecontrolstoprovideassurancesthatanyhazardsrequiringa

preventivecontrolwillbesignificantlyminimizedorpreventedandthefoodmanufactured,processed,packed,orheldbyyourfacilitywillnotbeadulteratedundersection402oftheFederalFood,Drug,andCosmeticActormisbrandedundersection403(w)oftheFederalFood,Drug,andCosmeticAct.(2)Preventivecontrolsrequiredbyparagraph(a)(1)ofthissectioninclude:

(i)Controlsatcriticalcontrolpoints(CCPs),ifthereareanyCCPs;and(ii)Controls,otherthanthoseatCCPs,thatarealsoappropriateforfoodsafety.

(b)Preventivecontrolsmustbewritten.(c)Preventivecontrolsinclude,asappropriatetothefacilityandthefood:

(1)Processcontrols.Processcontrolsincludeprocedures,practices,andprocessestoensurethecontrolofparametersduringoperationssuchasheatprocessing,acidifying,irradiating,andrefrigeratingfoods.Processcontrolsmustinclude,asappropriatetothenatureoftheapplicablecontrolanditsroleinthefacility’sfoodsafetysystem:

(i)Parametersassociatedwiththecontrolofthehazard;and(ii)Themaximumorminimumvalue,orcombinationofvalues,towhichanybiological,chemical,orphysicalparametermustbecontrolledtosignificantlyminimizeorpreventahazardrequiringaprocesscontrol.

(2)Foodallergencontrols.Foodallergencontrolsincludeprocedures,practices,andprocessestocontrolfoodallergens.Foodallergencontrolsmustincludethoseprocedures,practices,andprocessesemployedfor:

(i)Ensuringprotectionoffoodfromallergencross‐contact,includingduringstorage,handling,anduse;and(ii)Labelingthefinishedfood,includingensuringthatthefinishedfoodisnotmisbrandedundersection403(w)oftheFederalFood,Drug,andCosmeticAct.

(3)Sanitationcontrols.Sanitationcontrolsincludeprocedures,practices,andprocessestoensurethatthefacilityismaintainedinasanitaryconditionadequatetosignificantlyminimizeorpreventhazardssuchasenvironmentalpathogens,biologicalhazardsduetoemployeehandling,andfoodallergenhazards.Sanitationcontrolsmustinclude,asappropriatetothefacilityandthefood,procedures,practices,andprocessesforthe:

(i)Cleanlinessoffood‐contactsurfaces,includingfood‐contactsurfacesofutensilsandequipment;(ii)Preventionofallergencross‐contactandcross‐contaminationfrominsanitaryobjectsandfrompersonneltofood,foodpackagingmaterial,andotherfood‐contactsurfacesandfromrawproducttoprocessedproduct.

(4)Supply‐chaincontrols.Supply‐chaincontrolsincludethesupply‐chainprogramasrequiredbysubpartGofthispart.(5)Recallplan.Recallplanasrequiredby 117.13 .(6)Othercontrols.Preventivecontrolsincludeanyotherprocedures,practices,andprocessesnecessarytosatisfytherequirementsofparagraph(a)ofthissection.Examplesofothercontrolsincludehygienetrainingandothercurrentgoodmanufacturingpractices.

§ 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control. (a)Circumstances.Ifyouareamanufacturer/processor,youarenotrequiredtoimplementapreventivecontrolwhenyouidentifyahazardrequiringapreventivecontrol(identifiedhazard)andanyofthefollowingcircumstancesapply:

(1) oudetermineanddocumentthatthetypeoffood(e.g.,rawagriculturalcommoditiessuchascocoabeans,coffeebeans,andgrains)couldnotbeconsumedwithoutapplicationofanappropriatecontrol.(2) ourelyonyourcustomerwhoissubjecttotherequirementsforhazardanalysisandrisk‐basedpreventivecontrolsinthissubparttoensurethattheidentifiedhazardwillbesignificantlyminimizedorpreventedandyou:

(i)Discloseindocumentsaccompanyingthefood,inaccordancewiththepracticeofthetrade,thatthefoodis“notprocessedtocontrol identifiedhazard ”;and(ii)Annuallyobtainfromyourcustomerwrittenassurance,subjecttotherequirementsof 117.137,thatthecustomerhasestablishedandisfollowingprocedures(identifiedinthewrittenassurance)thatwillsignificantlyminimizeorpreventtheidentifiedhazard.

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(3) ourelyonyourcustomerwhoisnotsubjecttotherequirementsforhazardanalysisandrisk‐basedpreventivecontrolsinthissubparttoprovideassuranceitismanufacturing,processing,orpreparingthefoodinaccordancewithapplicablefoodsafetyrequirementsandyou:

(i)Discloseindocumentsaccompanyingthefood,inaccordancewiththepracticeofthetrade,thatthefoodis“notprocessedtocontrol identifiedhazard ”;and(ii)Annuallyobtainfromyourcustomerwrittenassurancethatitismanufacturing,processing,orpreparingthefoodinaccordancewithapplicablefoodsafetyrequirements.

(4) ourelyonyourcustomertoprovideassurancethatthefoodwillbeprocessedtocontroltheidentifiedhazardbyanentityinthedistributionchainsubsequenttothecustomerandyou:

(i)Discloseindocumentsaccompanyingthefood,inaccordancewiththepracticeofthetrade,thatthefoodis“notprocessedtocontrol identifiedhazard ”;and(ii)Annuallyobtainfromyourcustomerwrittenassurance,subjecttotherequirementsof 117.137,thatyourcustomer:

(A)Willdiscloseindocumentsaccompanyingthefood,inaccordancewiththepracticeofthetrade,thatthefoodis“notprocessedtocontrol identifiedhazard ”;and(B)Willonlyselltoanotherentitythatagrees,inwriting,itwill:

(1)Followprocedures(identifiedinawrittenassurance)thatwillsignificantlyminimizeorpreventtheidentifiedhazard(iftheentityissubjecttotherequirementsforhazardanalysisandrisk‐basedpreventivecontrolsinthissubpart)ormanufacture,process,orpreparethefoodinaccordancewithapplicablefoodsafetyrequirements(iftheentityisnotsubjecttotherequirementsforhazardanalysisandrisk‐basedpreventivecontrolsinthissubpart);or(2)Obtainasimilarwrittenassurancefromtheentity’scustomer,subjecttotherequirementsof 117.137,asinparagraphs(a)(4)(ii)(A)and(B)ofthissection,asappropriate;or

(5) ouhaveestablished,documented,andimplementedasystemthatensurescontrol,atasubsequentdistributionstep,ofthehazardsinthefoodyoudistributeandyoudocumenttheimplementationofthatsystem.

(b)Records. oumustdocumentanycircumstance,specifiedinparagraph(a)ofthissection,thatappliestoyou,including:

(1)Adetermination,inaccordancewithparagraph(a)ofthissection,thatthetypeoffoodcouldnotbeconsumedwithoutapplicationofanappropriatecontrol;(2)Theannualwrittenassurancefromyourcustomerinaccordancewithparagraph(a)(2)ofthissection;(3)Theannualwrittenassurancefromyourcustomerinaccordancewithparagraph(a)(3)ofthissection;(4)Theannualwrittenassurancefromyourcustomerinaccordancewithparagraph(a)(4)ofthissection;and(5) oursystem,inaccordancewithparagraph(a)(5)ofthissection,thatensurescontrol,atasubsequentdistributionstep,ofthehazardsinthefoodyoudistribute.

§ 117.137 Provision of assurances required under § 117.136(a)(2), (3), and (4). Afacilitythatprovidesawrittenassuranceunder 117.136(a)(2),(3),or(4)mustactconsistentlywiththeassuranceanddocumentitsactionstakentosatisfythewrittenassurance.§ 117.139 Recall plan. Forfoodwithahazardrequiringapreventivecontrol:(a) oumustestablishawrittenrecallplanforthefood.(b)Thewrittenrecallplanmustincludeproceduresthatdescribethestepstobetaken,andassignresponsibilityfortakingthosesteps,toperformthefollowingactionsasappropriatetothefacility:

(1)Directlynotifythedirectconsigneesofthefoodbeingrecalled,includinghowtoreturnordisposeoftheaffectedfood;(2)Notifythepublicaboutanyhazardpresentedbythefoodwhenappropriatetoprotectpublichealth;(3)Conducteffectivenesscheckstoverifythattherecalliscarriedout;and(4)Appropriatelydisposeofrecalledfood‐‐e.g.,throughreprocessing,reworking,divertingtoausethatdoesnotpresentasafetyconcern,ordestroyingthefood.

§ 117.140 Preventive control management components. (a)Exceptasprovidedbyparagraphs(b)and(c)ofthissection,thepreventivecontrolsrequiredunder 117.135aresubjecttothefollowingpreventivecontrolmanagementcomponentsasappropriatetoensuretheeffectivenessofthepreventivecontrols,takingintoaccountthenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem:

(1)Monitoringinaccordancewith 117.145;(2)Correctiveactionsandcorrectionsinaccordancewith 117.150;and(3)Verificationinaccordancewith 117.155.

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(b)Thesupply‐chainprogramestablishedinsubpartGofthispartissubjecttothefollowingpreventivecontrolmanagementcomponentsasappropriatetoensuretheeffectivenessofthesupply‐chainprogram,takingintoaccountthenatureofthehazardcontrolledbeforereceiptoftherawmaterialorotheringredient:

(1)Correctiveactionsandcorrectionsinaccordancewith 117.150,takingintoaccountthenatureofanysuppliernon‐conformance;(2)Reviewofrecordsinaccordancewith 117.165(a)(4);and(3)Reanalysisinaccordancewith 117.170.

(c)Therecallplanestablishedin 117.13 isnotsubjecttotherequirementsofparagraph(a)ofthissection.§ 117.145 Monitoring. Asappropriatetothenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem:(a)Writtenprocedures. oumustestablishandimplementwrittenprocedures,includingthefrequencywithwhichtheyaretobeperformed,formonitoringthepreventivecontrol;and(b)Monitoring. oumustmonitorthepreventivecontrolswithadequatefrequencytoprovideassurancethattheyareconsistentlyperformed.(c)Records.

(1)Requirementtodocumentmonitoring. oumustdocumentthemonitoringofpreventivecontrolsinaccordancewiththissectioninrecordsthataresubjecttoverificationinaccordancewith 117.155(a)(2)andrecordsreviewinaccordancewith 117.165(a)(4)(i).(2)Exceptionrecords.

(i)Recordsofrefrigerationtemperatureduringstorageoffoodthatrequirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogensmaybeaffirmativerecordsdemonstratingtemperatureiscontrolledorexceptionrecordsdemonstratinglossoftemperaturecontrol.(ii)Exceptionrecordsmaybeadequateincircumstancesotherthanmonitoringofrefrigerationtemperature.

§ 117.150 Corrective actions and corrections. (a)Correctiveactionprocedures.Asappropriatetothenatureofthehazardandthenatureofthepreventivecontrol,exceptasprovidedbyparagraph(c)ofthissection:

(1) oumustestablishandimplementwrittencorrectiveactionproceduresthatmustbetakenifpreventivecontrolsarenotproperlyimplemented,includingprocedurestoaddress,asappropriate:

(i)Thepresenceofapathogenorappropriateindicatororganisminaready‐to‐eatproductdetectedasaresultofproducttestingconductedinaccordancewith 117.165(a)(2);and(ii)Thepresenceofanenvironmentalpathogenorappropriateindicatororganismdetectedthroughtheenvironmentalmonitoringconductedinaccordancewith 117.165(a)(3).

(2)Thecorrectiveactionproceduresmustdescribethestepstobetakentoensurethat:(i)Appropriateactionistakentoidentifyandcorrectaproblemthathasoccurredwithimplementationofapreventivecontrol;(ii)Appropriateactionistaken,whennecessary,toreducethelikelihoodthattheproblemwillrecur;(iii)Allaffectedfoodisevaluatedforsafety;and(iv)Allaffectedfoodispreventedfromenteringintocommerce,ifyoucannotensurethattheaffectedfoodisnotadulteratedundersection402oftheFederalFood,Drug,andCosmeticActormisbrandedundersection403(w)oftheFederalFood,Drug,andCosmeticAct.

(b)Correctiveactionintheeventofanunanticipatedfoodsafetyproblem.(1)Exceptasprovidedbyparagraph(c)ofthissection,youaresubjecttotherequirementsofparagraphs(b)(2)ofthissectionifanyofthefollowingcircumstancesapply:

(i)Apreventivecontrolisnotproperlyimplementedandacorrectiveactionprocedurehasnotbeenestablished;(ii)Apreventivecontrol,combinationofpreventivecontrols,orthefoodsafetyplanasawholeisfoundtobeineffective;or(iii)Areviewofrecordsinaccordancewith 117.165(a)(4)findsthattherecordsarenotcomplete,theactivitiesconducteddidnotoccurinaccordancewiththefoodsafetyplan,orappropriatedecisionswerenotmadeaboutcorrectiveactions.

(2)Ifanyofthecircumstanceslistedinparagraph(b)(1)ofthissectionapply,youmust:(i)Takecorrectiveactiontoidentifyandcorrecttheproblem,reducethelikelihoodthattheproblemwillrecur,evaluateallaffectedfoodforsafety,and,asnecessary,preventaffectedfoodfromenteringcommerceaswouldbedonefollowingacorrectiveactionprocedureunderparagraphs(a)(2)(i)through(iv)ofthissection;and(ii)Whenappropriate,reanalyzethefoodsafetyplaninaccordancewith 117.170todeterminewhethermodificationofthefoodsafetyplanisrequired.

(c)Corrections. oudonotneedtocomplywiththerequirementsofparagraphs(a)and(b)ofthissectionif:(1) outakeaction,inatimelymanner,toidentifyandcorrectconditionsandpracticesthatarenotconsistentwiththefoodallergencontrolsin 117.135(c)(2)(i)orthesanitationcontrolsin 117.135(c)(3)(i)or(ii);or

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(2) outakeaction,inatimelymanner,toidentifyandcorrectaminorandisolatedproblemthatdoesnotdirectlyimpactproductsafety.

(d)Records.Allcorrectiveactions(and,whenappropriate,corrections)takeninaccordancewiththissectionmustbedocumentedinrecords.Theserecordsaresubjecttoverificationinaccordancewith 117.155(a)(3)andrecordsreviewinaccordancewith 117.165(a)(4)(i).§ 117.155 Verification. (a)Verificationactivities.Verificationactivitiesmustinclude,asappropriatetothenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem:

(1)Validationinaccordancewith 117.160.(2)Verificationthatmonitoringisbeingconductedasrequiredby 117.140(andinaccordancewith 117.145).(3)Verificationthatappropriatedecisionsaboutcorrectiveactionsarebeingmadeasrequiredby 117.140(andinaccordancewith 117.150).(4)Verificationofimplementationandeffectivenessinaccordancewith 117.165;and(5)Reanalysisinaccordancewith 117.170.

(b)Documentation.Allverificationactivitiesconductedinaccordancewiththissectionmustbedocumentedinrecords.§ 117.160 Validation. (a) oumustvalidatethatthepreventivecontrolsidentifiedandimplementedinaccordancewith 117.135areadequatetocontrolthehazardasappropriatetothenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem.(b)Thevalidationofthepreventivecontrols:

(1)Mustbeperformed(oroverseen)byapreventivecontrolsqualifiedindividual:(i)(A)Priortoimplementationofthefoodsafetyplan;or

(B)Whennecessarytodemonstratethecontrolmeasurescanbeimplementedasdesigned:(1)Within 0calendardaysafterproductionoftheapplicablefoodfirstbegins;or(2)Withinareasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)awrittenjustificationforatimeframethatexceeds 0calendardaysafterproductionoftheapplicablefoodfirstbegins;

(ii)Wheneverachangetoacontrolmeasureorcombinationofcontrolmeasurescouldimpactwhetherthecontrolmeasureorcombinationofcontrolmeasures,whenproperlyimplemented,willeffectivelycontrolthehazards;and(iii)Wheneverareanalysisofthefoodsafetyplanrevealstheneedtodoso;

(2)Mustincludeobtainingandevaluatingscientificandtechnicalevidence(or,whensuchevidenceisnotavailableorisinadequate,conductingstudies)todeterminewhetherthepreventivecontrols,whenproperlyimplemented,willeffectivelycontrolthehazards;and

(c) oudonotneedtovalidate:(1)Thefoodallergencontrolsin 117.135(c)(2);(2)Thesanitationcontrolsin 117.135(c)(3);(3)Therecallplanin 117.13 ;(4)Thesupply‐chainprograminsubpartGofthispart;and(5)Otherpreventivecontrols,ifthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)awrittenjustificationthatvalidationisnotapplicablebasedonfactorssuchasthenatureofthehazard,andthenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem.

§ 117.165 Verification of implementation and effectiveness. (a)Verificationactivities. oumustverifythatthepreventivecontrolsareconsistentlyimplementedandareeffectivelyandsignificantlyminimizingorpreventingthehazards.Todosoyoumustconductactivitiesthatincludethefollowing,asappropriatetothefacility,thefood,andthenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem:

(1)Calibrationofprocessmonitoringinstrumentsandverificationinstruments(orcheckingthemforaccuracy);(2)Producttesting,forapathogen(orappropriateindicatororganism)orotherhazard;(3)Environmentalmonitoring,foranenvironmentalpathogenorforanappropriateindicatororganism,ifcontaminationofaready‐to‐eatfoodwithanenvironmentalpathogenisahazardrequiringapreventivecontrol,bycollectingandtestingenvironmentalsamples;and(4)Reviewofthefollowingrecordswithinthespecifiedtimeframes,by(orundertheoversightof)apreventivecontrolsqualifiedindividual,toensurethattherecordsarecomplete,theactivitiesreflectedintherecordsoccurredinaccordancewiththefoodsafetyplan,thepreventivecontrolsareeffective,andappropriatedecisionsweremadeaboutcorrectiveactions:

(i)Recordsofmonitoringandcorrectiveactionrecordswithin7workingdaysaftertherecordsarecreatedorwithinareasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)awrittenjustificationforatimeframethatexceeds7workingdays;and

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(ii)Recordsofcalibration,testing(e.g.,producttesting,environmentalmonitoring),supplierandsupply‐chainverificationactivities,andotherverificationactivitieswithinareasonabletimeaftertherecordsarecreated;and

(5)Otheractivitiesappropriateforverificationofimplementationandeffectiveness.(b)Writtenprocedures.Asappropriatetothefacility,thefood,thenatureofthepreventivecontrol,andtheroleofthepreventivecontrolinthefacility’sfoodsafetysystem,youmustestablishandimplementwrittenproceduresforthefollowingactivities:

(1)Themethodandfrequencyofcalibratingprocessmonitoringinstrumentsandverificationinstruments(orcheckingthemforaccuracy)asrequiredbyparagraph(a)(1)ofthissection.(2)Producttestingasrequiredbyparagraph(a)(2)ofthissection.Proceduresforproducttestingmust:

(i)Bescientificallyvalid;(ii)Identifythetestmicroorganism(s)orotheranalyte(s);(iii)Specifytheproceduresforidentifyingsamples,includingtheirrelationshiptospecificlotsofproduct;(iv)Includetheproceduresforsampling,includingthenumberofsamplesandthesamplingfrequency;(v)Identifythetest(s)conducted,includingtheanalyticalmethod(s)used;(vi)Identifythelaboratoryconductingthetesting;and(vii)Includethecorrectiveactionproceduresrequiredby 117.150(a)(1).

(3)Environmentalmonitoringasrequiredbyparagraph(a)(3)ofthissection.Proceduresforenvironmentalmonitoringmust:

(i)Bescientificallyvalid;(ii)Identifythetestmicroorganism(s);(iii)Identifythelocationsfromwhichsampleswillbecollectedandthenumberofsitestobetestedduringroutineenvironmentalmonitoring.Thenumberandlocationofsamplingsitesmustbeadequatetodeterminewhetherpreventivecontrolsareeffective;(iv)Identifythetimingandfrequencyforcollectingandtestingsamples.Thetimingandfrequencyforcollectingandtestingsamplesmustbeadequatetodeterminewhetherpreventivecontrolsareeffective;(v)Identifythetest(s)conducted,includingtheanalyticalmethod(s)used;(vi)Identifythelaboratoryconductingthetesting;and(vii)Includethecorrectiveactionproceduresrequiredby 117.150(a)(1).

§ 117.170 Reanalysis. (a) oumustconductareanalysisofthefoodsafetyplanasawholeatleastonceevery3years;(b) oumustconductareanalysisofthefoodsafetyplanasawhole,ortheapplicableportionofthefoodsafetyplan:

(1)Wheneverasignificantchangeintheactivitiesconductedatyourfacilitycreatesareasonablepotentialforanewhazardorcreatesasignificantincreaseinapreviouslyidentifiedhazard;(2)Wheneveryoubecomeawareofnewinformationaboutpotentialhazardsassociatedwiththefood;(3)Wheneverappropriateafteranunanticipatedfoodsafetyprobleminaccordancewith 117.150(b);and(4)Wheneveryoufindthatapreventivecontrol,combinationofpreventivecontrols,orthefoodsafetyplanasawholeisineffective.

(c) oumustcompletethereanalysisrequiredbyparagraphs(a)and(b)ofthissectionandvalidate,asappropriatetothenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem,anyadditionalpreventivecontrolsneededtoaddressthehazardidentified:

(1)Beforeanychangeinactivities(includinganychangeinpreventivecontrol)atthefacilityisoperative;or(2)Whennecessarytodemonstratethecontrolmeasurescanbeimplementedasdesigned:

(i)Within 0calendardaysafterproductionoftheapplicablefoodfirstbegins;or(ii)Withinareasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)awrittenjustificationforatimeframethatexceeds 0‐calendardaysafterproductionoftheapplicablefoodfirstbegins.

(d) oumustrevisethewrittenfoodsafetyplanifasignificantchangeintheactivitiesconductedatyourfacilitycreatesareasonablepotentialforanewhazardorasignificantincreaseinapreviouslyidentifiedhazardordocumentthebasisfortheconclusionthatnorevisionsareneeded.(e)Apreventivecontrolsqualifiedindividualmustperform(oroversee)thereanalysis.(f) oumustconductareanalysisofthefoodsafetyplanwhenFDAdeterminesitisnecessarytorespondtonewhazardsanddevelopmentsinscientificunderstanding.§ 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor. (a)Oneormorepreventivecontrolsqualifiedindividualsmustdooroverseethefollowing:

(1)Preparationofthefoodsafetyplan( 117.126(a)(2));(2)Validationofthepreventivecontrols( 117.160(b)(1));(3)Writtenjustificationforvalidationtobeperformedinatimeframethatexceedsthefirst 0calendardaysofproductionoftheapplicablefood;

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(4)Determinationthatvalidationisnotrequired( 117.160(c)(5));(5)Reviewofrecords( 117.165(a)(4));(6)Writtenjustificationforreviewofrecordsofmonitoringandcorrectiveactionswithinatimeframethatexceeds7workingdays;(7)Reanalysisofthefoodsafetyplan( 117.170(d));and(8)Determinationthatreanalysiscanbecompleted,andadditionalpreventivecontrolsvalidated,asappropriatetothenatureofthepreventivecontrolanditsroleinthefacility’sfoodsafetysystem,inatimeframethatexceedsthefirst 0calendardaysofproductionoftheapplicablefood.

(b)Aqualifiedauditormustconductanonsiteaudit( 117.435(a)).(c)(1)Tobeapreventivecontrolsqualifiedindividual,theindividualmusthavesuccessfullycompletedtraininginthe

developmentandapplicationofrisk‐basedpreventivecontrolsatleastequivalenttothatreceivedunderastandardizedcurriculumrecognizedasadequatebyFDAorbeotherwisequalifiedthroughjobexperiencetodevelopandapplyafoodsafetysystem.Jobexperiencemayqualifyanindividualtoperformthesefunctionsifsuchexperiencehasprovidedanindividualwithknowledgeatleastequivalenttothatprovidedthroughthestandardizedcurriculum.Thisindividualmaybe,butisnotrequiredtobe,anemployeeofthefacility.(2)Tobeaqualifiedauditor,aqualifiedindividualmusthavetechnicalexpertiseobtainedthrougheducation,training,orexperience(oracombinationthereof)necessarytoperformtheauditingfunction.

(d)Allapplicabletraininginthedevelopmentandapplicationofrisk‐basedpreventivecontrolsmustbedocumentedinrecords,includingthedateofthetraining,thetypeoftraining,andtheperson(s)trained.§ 117.190 Implementation records required for this subpart. (a) oumustestablishandmaintainthefollowingrecordsdocumentingimplementationofthefoodsafetyplan:

(1)Documentation,asrequiredby 117.136(b),ofthebasisfornotestablishingapreventivecontrolinaccordancewith 117.136(a);(2)Recordsthatdocumentthemonitoringofpreventivecontrols;(3)Recordsthatdocumentcorrectiveactions;(4)Recordsthatdocumentverification,including,asapplicable,thoserelatedto:

(i)Validation;(ii)Verificationofmonitoring;(iii)Verificationofcorrectiveactions;(iv)Calibrationofprocessmonitoringandverificationinstruments;(v)Producttesting;(vi)Environmentalmonitoring;(vii)Recordsreview;and(viii)Reanalysis;

(5)Recordsthatdocumentthesupply‐chainprogram;and(6)Recordsthatdocumentapplicabletrainingforthepreventivecontrolsqualifiedindividualandthequalifiedauditor.

(b)TherecordsthatyoumustestablishandmaintainaresubjecttotherequirementsofsubpartFofthispart.

Subpart D – Modified Requirements § 117.201 Modified requirements that apply to a qualified facility. (a)Attestationstobesubmitted.AqualifiedfacilitymustsubmitthefollowingattestationstoFDA:

(1)Anattestationthatthefacilityisaqualifiedfacilityasdefinedin 117.3.Forthepurposeofdeterminingwhetherafacilitysatisfiesthedefinitionofqualifiedfacility,thebaselineyearforcalculatingtheadjustmentforinflationis2011;and(2)(i)Anattestationthatyouhaveidentifiedthepotentialhazardsassociatedwiththefoodbeingproduced,areimplementingpreventivecontrolstoaddressthehazards,andaremonitoringtheperformanceofthepreventivecontrolstoensurethatsuchcontrolsareeffective;or

(ii)AnattestationthatthefacilityisincompliancewithState,local,county,tribal,orotherapplicablenon‐Federalfoodsafetylaw,includingrelevantlawsandregulationsofforeigncountries,includinganattestationbasedonlicenses,inspectionreports,certificates,permits,credentials,certificationbyanappropriateagency(suchasaStatedepartmentofagriculture),orotherevidenceofoversight.

(b)Procedureforsubmission.Theattestationsrequiredbyparagraph(a)ofthissectionmustbesubmittedtoFDAbyoneofthefollowingmeans:

(1)Electronicsubmission.Tosubmitelectronically,gotohttp://www.fda.gov/furlsandfollowtheinstructions.ThisWebsiteisavailablefromwherevertheInternetisaccessible,includinglibraries,copycenters,schools,andInternetcafes.FDAencourageselectronicsubmission.(2)Submissionbymail.

(i) oumustuseFormFDA3 42a. oumayobtainacopyofthisformbyanyofthefollowingmechanisms:

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(A)Downloaditfromhttp://www.fda.gov/pchfrule;(B)WritetotheU.S.FoodandDrugAdministration(HFS‐681),5100PaintBranchParkway,CollegePark,MD20740;or(C)Requestacopyofthisformbyphoneat1‐800‐216‐7331or301‐575‐0156.

(ii)SendapaperFormFDA3 42atotheU.S.FoodandDrugAdministration(HFS‐681),5100PaintBranchParkway,CollegePark,MD20740.WerecommendthatyousubmitapapercopyonlyifyourfacilitydoesnothavereasonableaccesstotheInternet.

(c)Frequencyofdeterminationofstatusandsubmission.(1)AfacilitymustdetermineanddocumentitsstatusasaqualifiedfacilityonanannualbasisnolaterthanJuly1ofeachcalendaryear.(2)Theattestationsrequiredbyparagraph(a)ofthissectionmustbe:

(i)SubmittedtoFDAinitially:(A)ByDecember17,2018,forafacilitythatbeginsmanufacturing,processing,packing,orholdingfoodbeforeSeptember17,2018;(B)Beforebeginningoperations,forafacilitythatbeginsmanufacturing,processing,packing,orholdingfoodafterSeptember17,2018;or(C)ByJuly31oftheapplicablecalendaryear,whenthestatusofafacilitychangesfrom“notaqualifiedfacility”to“qualifiedfacility”basedontheannualdeterminationrequiredbyparagraph(c)(1)ofthissection;and

(ii)Beginningin2020,submittedtoFDAevery2yearsduringtheperiodbeginningonOctober1andendingonDecember31.

(3)Whenthestatusofafacilitychangesfrom“qualifiedfacility”to“notaqualifiedfacility”basedontheannualdeterminationrequiredbyparagraph(c)(1)ofthissection,thefacilitymustnotifyFDAofthatchangeinstatususingForm3 42abyJuly31oftheapplicablecalendaryear.

(d)TimeframeforcompliancewithsubpartsCandGofthispartwhenthefacilitystatuschangesto“notaqualifiedfacility.”Whenthestatusofafacilitychangesfrom“qualifiedfacility”to“notaqualifiedfacility,”thefacilitymustcomplywithsubpartsCandGofthispartnolaterthanDecember31oftheapplicablecalendaryearunlessotherwiseagreedtobyFDAandthefacility.(e)Notificationtoconsumers.Aqualifiedfacilitythatdoesnotsubmitattestationsunderparagraph(a)(2)(i)ofthissectionmustprovidenotificationtoconsumersastothenameandcompletebusinessaddressofthefacilitywherethefoodwasmanufacturedorprocessed(includingthestreetaddressorP.O.box,city,state,andzipcodefordomesticfacilities,andcomparablefulladdressinformationforforeignfacilities),asfollows:

(1)Ifafoodpackaginglabelisrequired,thenotificationrequiredbyparagraph(e)ofthissectionmustappearprominentlyandconspicuouslyonthelabelofthefood.(2)Ifafoodpackaginglabelisnotrequired,thenotificationrequiredbyparagraph(e)ofthissectionmustappearprominentlyandconspicuously,atthepointofpurchase,onalabel,poster,sign,placard,ordocumentsdeliveredcontemporaneouslywiththefoodinthenormalcourseofbusiness,orinanelectronicnotice,inthecaseofInternetsales.

(f)Records.(1)Aqualifiedfacilitymustmaintainthoserecordsreliedupontosupporttheattestationsthatarerequiredbyparagraph(a)ofthissection.(2)TherecordsthataqualifiedfacilitymustmaintainaresubjecttotherequirementsofsubpartFofthispart.

§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food. (a)Ifafacilitythatissolelyengagedinthestorageofunexposedpackagedfoodstoresanysuchrefrigeratedpackagedfoodthatrequirestime/temperaturecontroltosignificantlyminimizeorpreventthegrowthof,ortoxinproductionbypathogens,thefacilitymustconductthefollowingactivitiesasappropriatetoensuretheeffectivenessofthetemperaturecontrols:

(1)Establishandimplementtemperaturecontrolsadequatetosignificantlyminimizeorpreventthegrowthof,ortoxinproductionby,pathogens;(2)Monitorthetemperaturecontrolswithadequatefrequencytoprovideassurancethatthetemperaturecontrolsareconsistentlyperformed;(3)Ifthereisalossoftemperaturecontrolthatmayimpactthesafetyofsuchrefrigeratedpackagedfood,takeappropriatecorrectiveactionsto:

(i)Correcttheproblemandreducethelikelihoodthattheproblemwillrecur;(ii)Evaluateallaffectedfoodforsafety;and(iii)Preventthefoodfromenteringcommerce,ifyoucannotensuretheaffectedfoodisnotadulteratedundersection402oftheFederalFood,Drug,andCosmeticAct;

(4)Verifythattemperaturecontrolsareconsistentlyimplementedby:(i)Calibratingtemperaturemonitoringandrecordingdevices(orcheckingthemforaccuracy);

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(ii)Reviewingrecordsofcalibrationwithinareasonabletimeaftertherecordsarecreated;and(iii)Reviewingrecordsofmonitoringandcorrectiveactionstakentocorrectaproblemwiththecontroloftemperaturewithin7workingdaysaftertherecordsarecreatedorwithinareasonabletimeframe,providedthatthepreventivecontrolsqualifiedindividualprepares(oroverseesthepreparationof)awrittenjustificationforatimeframethatexceeds7workingdays;

(5)Establishandmaintainthefollowingrecords:(i)Records(whetheraffirmativerecordsdemonstratingtemperatureiscontrolledorexceptionrecordsdemonstratinglossoftemperaturecontrol)documentingthemonitoringoftemperaturecontrolsforanysuchrefrigeratedpackagedfood;(ii)Recordsofcorrectiveactionstakenwhenthereisalossoftemperaturecontrolthatmayimpactthesafetyofanysuchrefrigeratedpackagedfood;and(iii)Recordsdocumentingverificationactivities.

(b)Therecordsthatafacilitymustestablishandmaintainunderparagraph(a)(5)ofthissectionaresubjecttotherequirementsofsubpartFofthispart.

Subpart E – Withdrawal of a Qualified Facility Exemption § 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption. (a)FDAmaywithdrawaqualifiedfacilityexemptionunder 117.5(a):

(1)Intheeventofanactiveinvestigationofafoodborneillnessoutbreakthatisdirectlylinkedtothequalifiedfacility;or(2)IfFDAdeterminesthatitisnecessarytoprotectthepublichealthandpreventormitigateafoodborneillnessoutbreakbasedonconditionsorconductassociatedwiththequalifiedfacilitythatarematerialtothesafetyofthefoodmanufactured,processed,packed,orheldatsuchfacility.

(b)BeforeFDAissuesanordertowithdrawaqualifiedfacilityexemption,FDA:(1)Mayconsideroneormoreotheractionstoprotectthepublichealthormitigateafoodborneillnessoutbreak,includingawarningletter,recall,administrativedetention,suspensionofregistration,refusaloffoodofferedforimport,seizure,andinjunction;(2)Mustnotifytheowner,operator,oragentinchargeofthefacility,inwriting,ofcircumstancesthatmayleadFDAtowithdrawtheexemption,andprovideanopportunityfortheowner,operator,oragentinchargeofthefacilitytorespondinwriting,within15calendardaysofthedateofreceiptofthenotification,toFDA’snotification;and(3)MustconsidertheactionstakenbythefacilitytoaddressthecircumstancesthatmayleadFDAtowithdrawtheexemption.

§ 117.254 Issuance of an order to withdraw a qualified facility exemption. (a)AnFDADistrictDirectorinwhosedistrictthequalifiedfacilityislocated(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition),oranFDAofficialseniortoeithersuchDirector,mustapproveanordertowithdrawtheexemptionbeforetheorderisissued.(b)AnyofficerorqualifiedemployeeofFDAmayissueanordertowithdrawtheexemptionafterithasbeenapprovedinaccordancewithparagraph(a)ofthissection.(c)FDAmustissueanordertowithdrawtheexemptiontotheowner,operator,oragentinchargeofthefacility.(d)FDAmustissueanordertowithdrawtheexemptioninwriting,signedanddatedbytheofficerorqualifiedemployeeofFDAwhoisissuingtheorder.§ 117.257 Contents of an order to withdraw a qualified facility exemption. Anordertowithdrawaqualifiedfacilityexemptionunder 117.5(a)mustincludethefollowinginformation:(a)Thedateoftheorder;(b)Thename,address,andlocationofthequalifiedfacility;(c)Abrief,generalstatementofthereasonsfortheorder,includinginformationrelevanttooneorbothofthefollowingcircumstancesthatleadsFDAtoissuetheorder:

(1)Anactiveinvestigationofafoodborneillnessoutbreakthatisdirectlylinkedtothefacility;or(2)Conditionsorconductassociatedwithaqualifiedfacilitythatarematerialtothesafetyofthefoodmanufactured,processed,packed,orheldatsuchfacility.

(d)Astatementthatthefacilitymusteither:(1)ComplywithsubpartsCandGofthispartonthedatethatis120calendardaysafterthedateofreceiptoftheorder,orwithinareasonabletimeframe,agreedtobyFDA,basedonawrittenjustification,submittedtoFDA,foratimeframethatexceeds120calendardaysfromthedateofreceiptoftheorder;or(2)Appealtheorderwithin15calendardaysofthedateofreceiptoftheorderinaccordancewiththerequirementsof 117.264.

(e)AstatementthatafacilitymayrequestthatFDAreinstateanexemptionthatwaswithdrawnbyfollowingtheproceduresin 117.287;(f)Thetextofsection418(l)oftheFederalFood,Drug,andCosmeticActandofthissubpart;

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(g)Astatementthatanyinformalhearingonanappealoftheordermustbeconductedasaregulatoryhearingunderpart16ofthischapter,withcertainexceptionsdescribedin 117.270;(h)Themailingaddress,telephonenumber,emailaddress,andfacsimilenumberoftheFDAdistrictofficeandthenameoftheFDADistrictDirectorinwhosedistrictthefacilityislocated(or,inthecaseofaforeignfacility,thesameinformationfortheDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition);and(i)ThenameandthetitleoftheFDArepresentativewhoapprovedtheorder.§ 117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption. (a)Ifyoureceiveanorderunder 117.254towithdrawaqualifiedfacilityexemption,youmusteither:

(1)Complywithapplicablerequirementsofthispartwithin120calendardaysofthedateofreceiptoftheorder,orwithinareasonabletimeframe,agreedtobyFDA,basedonawrittenjustification,submittedtoFDA,foratimeframethatexceeds120calendardaysfromthedateofreceiptoftheorder;or(2)Appealtheorderwithin15calendardaysofthedateofreceiptoftheorderinaccordancewiththerequirementsof 117.264.

(b)Submissionofanappeal,includingsubmissionofarequestforaninformalhearing,willnotoperatetodelayorstayanyadministrativeaction,includingenforcementactionbyFDA,unlesstheCommissionerofFoodandDrugs,asamatterofdiscretion,determinesthatdelayorastayisinthepublicinterest.(c)Ifyouappealtheorder,andFDAconfirmstheorder:

(1) oumustcomplywithapplicablerequirementsofthispartwithin120calendardaysofthedateofreceiptoftheorder,orwithinareasonabletimeframe,agreedtobyFDA,basedonawrittenjustification,submittedtoFDA,foratimeframethatexceeds120calendardaysfromthedateofreceiptoftheorder;and(2) ouarenolongersubjecttothemodifiedrequirementsin 117.201.

§ 117.264 Procedure for submitting an appeal. (a)Toappealanordertowithdrawaqualifiedfacilityexemption,youmust:

(1)SubmittheappealinwritingtotheFDADistrictDirectorinwhosedistrictthefacilityislocated(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition),atthemailingaddress,emailaddress,orfacsimilenumberidentifiedintheorderwithin15calendardaysofthedateofreceiptofconfirmationoftheorder;and(2)Respondwithparticularitytothefactsandissuescontainedintheorder,includinganysupportingdocumentationuponwhichyourely.

(b)Inawrittenappealoftheorderwithdrawinganexemptionprovidedunder 117.5(a),youmayincludeawrittenrequestforaninformalhearingasprovidedin 117.267.§ 117.267 Procedure for requesting an informal hearing. (a)Ifyouappealtheorder,you:

(1)Mayrequestaninformalhearing;and(2)Mustsubmitanyrequestforaninformalhearingtogetherwithyourwrittenappealsubmittedinaccordancewith117.264within15calendardaysofthedateofreceiptoftheorder.

(b)Arequestforaninformalhearingmaybedenied,inwholeorinpart,ifthepresidingofficerdeterminesthatnogenuineandsubstantialissueofmaterialfacthasbeenraisedbythematerialsubmitted.Ifthepresidingofficerdeterminesthatahearingisnotjustified,writtennoticeofthedeterminationwillbegiventoyouexplainingthereasonforthedenial.§ 117.270 Requirements applicable to an informal hearing. Ifyourequestaninformalhearing,andFDAgrantstherequest:(a)Thehearingwillbeheldwithin15calendardaysafterthedatetheappealisfiledor,ifapplicable,withinatimeframeagreeduponinwritingbyyouandFDA.(b)Thepresidingofficermayrequirethatahearingconductedunderthissubpartbecompletedwithin1‐calendarday,asappropriate.(c)FDAmustconductthehearinginaccordancewithpart16ofthischapter,exceptthat:

(1)Theorderwithdrawinganexemptionunder 117.254and117.257,ratherthanthenoticeunder 16.22(a)ofthischapter,providesnoticeofopportunityforahearingunderthissectionandispartoftheadministrativerecordoftheregulatoryhearingunder 16.80(a)ofthischapter.(2)ArequestforahearingunderthissubpartmustbeaddressedtotheFDADistrictDirector(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)asprovidedintheorderwithdrawinganexemption.(3)Section117.274,ratherthan 16.42(a)ofthischapter,describestheFDAemployeeswhopresideathearingsunderthissubpart.(4)Section16.60(e)and(f)ofthischapterdoesnotapplytoahearingunderthissubpart.Thepresidingofficermustprepareawrittenreportofthehearing.Allwrittenmaterialpresentedatthehearingwillbeattachedtothereport.Thepresidingofficermustincludeaspartofthereportofthehearingafindingonthecredibilityofwitnesses(other

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thanexpertwitnesses)whenevercredibilityisamaterialissue,andmustincludeaproposeddecision,withastatementofreasons.Thehearingparticipantmayreviewandcommentonthepresidingofficer’sreportwithin2‐calendardaysofissuanceofthereport.Thepresidingofficerwillthenissuethefinaldecision.(5)Section16.80(a)(4)ofthischapterdoesnotapplytoaregulatoryhearingunderthissubpart.Thepresidingofficer’sreportofthehearingandanycommentsonthereportbythehearingparticipantunder 117.270(c)(4)arepartoftheadministrativerecord.(6)Nopartyshallhavetheright,under 16.11 ofthischaptertopetitiontheCommissionerofFoodandDrugsforreconsiderationorastayofthepresidingofficer’sfinaldecision.(7)IfFDAgrantsarequestforaninformalhearingonanappealofanorderwithdrawinganexemption,thehearingmustbeconductedasaregulatoryhearingunderaregulationinaccordancewithpart16ofthischapter,exceptthat16. 5(b)ofthischapterdoesnotapplytoahearingunderthissubpart.Withrespecttoaregulatoryhearingunderthissubpart,theadministrativerecordofthehearingspecifiedin 16.80(a)(1)through(3)and(a)(5)ofthischapterand117.270(c)(5)constitutestheexclusiverecordforthepresidingofficer’sfinaldecision.Forpurposesofjudicialreviewunder 10.45ofthischapter,therecordoftheadministrativeproceedingconsistsoftherecordofthehearingandthepresidingofficer’sfinaldecision.

§ 117.274 Presiding officer for an appeal and for an informal hearing. Thepresidingofficerforanappeal,andforaninformalhearing,mustbeanFDARegionalFoodandDrugDirectororanotherFDAofficialseniortoanFDADistrictDirector.§ 117.277 Timeframe for issuing a decision on an appeal. (a)Ifyouappealtheorderwithoutrequestingahearing,thepresidingofficermustissueawrittenreportthatincludesafinaldecisionconfirmingorrevokingthewithdrawalbythe10thcalendardayaftertheappealisfiled.(b)Ifyouappealtheorderandrequestaninformalhearing:

(1)IfFDAgrantstherequestforahearingandthehearingisheld,thepresidingofficermustprovidea2‐calendardayopportunityforthehearingparticipantstoreviewandsubmitcommentsonthereportofthehearingunder 117.270(c)(4),andmustissueafinaldecisionwithin10‐calendardaysafterthehearingisheld;or(2)IfFDAdeniestherequestforahearing,thepresidingofficermustissueafinaldecisionontheappealconfirmingorrevokingthewithdrawalwithin10calendardaysafterthedatetheappealisfiled.

§ 117.280 Revocation of an order to withdraw a qualified facility exemption. Anordertowithdrawaqualifiedfacilityexemptionisrevokedif:(a) ouappealtheorderandrequestaninformalhearing,FDAgrantstherequestforaninformalhearing,andthepresidingofficerdoesnotconfirmtheorderwithinthe10‐calendardaysafterthehearing,orissuesadecisionrevokingtheorderwithinthattime;or(b) ouappealtheorderandrequestaninformalhearing,FDAdeniestherequestforaninformalhearing,andFDAdoesnotconfirmtheorderwithinthe10‐calendardaysaftertheappealisfiled,orissuesadecisionrevokingtheorderwithinthattime;or(c) ouappealtheorderwithoutrequestinganinformalhearing,andFDAdoesnotconfirmtheorderwithinthe10‐calendardaysaftertheappealisfiled,orissuesadecisionrevokingtheorderwithinthattime.§ 117.284 Final agency action. Confirmationofawithdrawalorderbythepresidingofficerisconsideredafinalagencyactionforpurposesof5U.S.C.702.§ 117.287 Reinstatement of a qualified facility exemption that was withdrawn. (a)IftheFDADistrictDirectorinwhosedistrictyourfacilityislocated(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)determinesthatafacilityhasadequatelyresolvedanyproblemswiththeconditionsandconductthatarematerialtothesafetyofthefoodmanufactured,processed,packed,orheldatthefacilityandthatcontinuedwithdrawaloftheexemptionisnotnecessarytoprotectpublichealthandpreventormitigateafoodborneillnessoutbreak,theFDADistrictDirectorinwhosedistrictyourfacilityislocated(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition)will,onhisowninitiativeorontherequestofafacility,reinstatetheexemption.(b) oumayaskFDAtoreinstateanexemptionthathasbeenwithdrawnundertheproceduresofthissubpartasfollows:

(1)Submitarequest,inwriting,totheFDADistrictDirectorinwhosedistrictyourfacilityislocated(or,inthecaseofaforeignfacility,theDirectoroftheOfficeofComplianceintheCenterforFoodSafetyandAppliedNutrition);and(2)Presentdataandinformationtodemonstratethatyouhaveadequatelyresolvedanyproblemswiththeconditionsandconductthatarematerialtothesafetyofthefoodmanufactured,processed,packed,orheldatyourfacility,suchthatcontinuedwithdrawaloftheexemptionisnotnecessarytoprotectpublichealthandpreventormitigateafoodborneillnessoutbreak.

(c)Ifyourexemptionwaswithdrawnunder 117.251(a)(1)andFDAlaterdetermines,afterfinishingtheactiveinvestigationofafoodborneillnessoutbreak,thattheoutbreakisnotdirectlylinkedtoyourfacility,FDAwillreinstateyourexemptionunder 117.5(a),andFDAwillnotifyyouinwritingthatyourexemptstatushasbeenreinstated.

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(d)Ifyourexemptionwaswithdrawnunderboth 117.251(a)(1)and(2)andFDAlaterdetermines,afterfinishingtheactiveinvestigationofafoodborneillnessoutbreak,thattheoutbreakisnotdirectlylinkedtoyourfacility,FDAwillinformyouofthisfinding,andyoumayaskFDAtoreinstateyourexemptionunder 117.5(a)inaccordancewiththerequirementsofparagraph(b)ofthissection.

Subpart F‐‐Requirements Applying to Records That Must Be Established and Maintained § 117.301 Records subject to the requirements of this subpart. (a)Exceptasprovidedbyparagraphs(b)and(c)ofthissection,allrecordsrequiredbythispartaresubjecttoallrequirementsofthissubpart.(b)Therequirementsof 117.310applyonlytothewrittenfoodsafetyplan.(c)Therequirementsof 117.305(b),(d),(e),and(f)donotapplytotherecordsrequiredby 117.201.§ 117.305 General requirements applying to records. Recordsmust:(a)Bekeptasoriginalrecords,truecopies(suchasphotocopies,pictures,scannedcopies,microfilm,microfiche,orotheraccuratereproductionsoftheoriginalrecords),orelectronicrecords;(b)Containtheactualvaluesandobservationsobtainedduringmonitoringand,asappropriate,duringverificationactivities;(c)Beaccurate,indelible,andlegible;(d)Becreatedconcurrentlywithperformanceoftheactivitydocumented;(e)Beasdetailedasnecessarytoprovidehistoryofworkperformed;and(f)Include:

(1)Informationadequatetoidentifytheplantorfacility(e.g.,thename,andwhennecessary,thelocationoftheplantorfacility);(2)Thedateand,whenappropriate,thetimeoftheactivitydocumented;(3)Thesignatureorinitialsofthepersonperformingtheactivity;and(4)Whereappropriate,theidentityoftheproductandthelotcode,ifany.

(g)Recordsthatareestablishedormaintainedtosatisfytherequirementsofthispartandthatmeetthedefinitionofelectronicrecordsin 11.3(b)(6)ofthischapterareexemptfromtherequirementsofpart11ofthischapter.Recordsthatsatisfytherequirementsofthispart,butthatalsoarerequiredunderotherapplicablestatutoryprovisionsorregulations,remainsubjecttopart11ofthischapter.§ 117.310 Additional requirements applying to the food safety plan. Theowner,operator,oragentinchargeofthefacilitymustsignanddatethefoodsafetyplan:(a)Uponinitialcompletion;and(b)Uponanymodification.§ 117.315 Requirements for record retention. (a)(1)Allrecordsrequiredbythispartmustberetainedattheplantorfacilityforatleast2yearsafterthedatetheywere

prepared.(2)Recordsthatafacilityreliesonduringthe3‐yearperiodprecedingtheapplicablecalendaryeartosupportitsstatusasaqualifiedfacilitymustberetainedatthefacilityaslongasnecessarytosupportthestatusofafacilityasaqualifiedfacilityduringtheapplicablecalendaryear.

(b)Recordsthatrelatetothegeneraladequacyoftheequipmentorprocessesbeingusedbyafacility,includingtheresultsofscientificstudiesandevaluations,mustberetainedbythefacilityforatleast2yearsaftertheiruseisdiscontinued(e.g.,becausethefacilityhasupdatedthewrittenfoodsafetyplan( 117.126)orrecordsthatdocumentvalidationofthewrittenfoodsafetyplan( 117.155(b)));(c)Exceptforthefoodsafetyplan,offsitestorageofrecordsispermittedifsuchrecordscanberetrievedandprovidedonsitewithin24hoursofrequestforofficialreview.Thefoodsafetyplanmustremainonsite.Electronicrecordsareconsideredtobeonsiteiftheyareaccessiblefromanonsitelocation.(d)Iftheplantorfacilityisclosedforaprolongedperiod,thefoodsafetyplanmaybetransferredtosomeotherreasonablyaccessiblelocationbutmustbereturnedtotheplantorfacilitywithin24hoursforofficialreviewuponrequest.§ 117.320 Requirements for official review. AllrecordsrequiredbythispartmustbemadepromptlyavailabletoadulyauthorizedrepresentativeoftheSecretaryofHealthandHumanServicesforofficialreviewandcopyinguponoralorwrittenrequest.§ 117.325 Public disclosure. RecordsobtainedbyFDAinaccordancewiththispartaresubjecttothedisclosurerequirementsunderpart20ofthischapter.

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§ 117.330 Use of existing records. (a)Existingrecords(e.g.,recordsthatarekepttocomplywithotherFederal,State,orlocalregulations,orforanyotherreason)donotneedtobeduplicatediftheycontainalloftherequiredinformationandsatisfytherequirementsofthissubpart.Existingrecordsmaybesupplementedasnecessarytoincludealloftherequiredinformationandsatisfytherequirementsofthissubpart.(b)Theinformationrequiredbythispartdoesnotneedtobekeptinonesetofrecords.Ifexistingrecordscontainsomeoftherequiredinformation,anynewinformationrequiredbythispartmaybekepteitherseparatelyorcombinedwiththeexistingrecords.§ 117.335 Special requirements applicable to a written assurance. (a)Anywrittenassurancerequiredbythispartmustcontainthefollowingelements:

(1)Effectivedate;(2)Printednamesandsignaturesofauthorizedofficials;(3)Theapplicableassuranceunder:

(i)Section117.136(a)(2);(ii)Section117.136(a)(3);(iii)Section117.136(a)(4);(iv)Section117.430(c)(2);(v)Section117.430(d)(2);or(vi)Section117.430(e)(2);

(b)Awrittenassurancerequiredunder 117.136(a)(2),(3),or(4)mustinclude:(1)Acknowledgementthatthefacilitythatprovidesthewrittenassuranceassumeslegalresponsibilitytoactconsistentlywiththeassuranceanddocumentitsactionstakentosatisfythewrittenassurance;and(2)Provisionthatiftheassuranceisterminatedinwritingbyeitherentity,responsibilityforcompliancewiththeapplicableprovisionsofthispartrevertstothemanufacturer/processorasofthedateoftermination.

Subpart G‐‐Supply‐Chain Program § 117.405 Requirement to establish and implement a supply‐chain program. (a)(1)Exceptasprovidedbyparagraphs(a)(2)and(3)ofthissection,thereceivingfacilitymustestablishandimplement

arisk‐basedsupply‐chainprogramforthoserawmaterialsandotheringredientsforwhichthereceivingfacilityhasidentifiedahazardrequiringasupply‐chain‐appliedcontrol.(2)Areceivingfacilitythatisanimporter,isincompliancewiththeforeignsupplierverificationprogramrequirementsunderpart1,subpartLofthischapter,andhasdocumentationofverificationactivitiesconductedunder 1.506(e)ofthischapter(whichprovidesassurancethatthehazardsrequiringasupply‐chain‐appliedcontrolfortherawmaterialorotheringredienthavebeensignificantlyminimizedorprevented)neednotconductsupplierverificationactivitiesforthatrawmaterialorotheringredient.(3)Therequirementsinthissubpartdonotapplytofoodthatissuppliedforresearchorevaluationuse,providedthatsuchfood:

(i)Isnotintendedforretailsaleandisnotsoldordistributedtothepublic;(ii)Islabeledwiththestatement“Foodforresearchorevaluationuse”;(iii)Issuppliedinasmallquantitythatisconsistentwitharesearch,analysis,orqualityassurancepurpose,thefoodisusedonlyforthispurpose,andanyunusedquantityisproperlydisposedof;and(iv)Isaccompaniedwithdocuments,inaccordancewiththepracticeofthetrade,statingthatthefoodwillbeusedforresearchorevaluationpurposesandcannotbesoldordistributedtothepublic.

(b)Thesupply‐chainprogrammustbewritten.(c)Whenasupply‐chain‐appliedcontrolisappliedbyanentityotherthanthereceivingfacility’ssupplier(e.g.,whenanon‐supplierappliescontrolstocertainproduce(i.e.,producecoveredbypart112ofthischapter),becausegrowing,harvesting,andpackingactivitiesareunderdifferentmanagement),thereceivingfacilitymust:

(1)Verifythesupply‐chain‐appliedcontrol;or(2)Obtaindocumentationofanappropriateverificationactivityfromanotherentity,reviewandassesstheentity’sapplicabledocumentation,anddocumentthatreviewandassessment.

§ 117.410 General requirements applicable to a supply‐chain program. (a)Thesupply‐chainprogrammustinclude:

(1)Usingapprovedsuppliersasrequiredby 117.420;(2)Determiningappropriatesupplierverificationactivities(includingdeterminingthefrequencyofconductingtheactivity)asrequiredby 117.425;(3)Conductingsupplierverificationactivitiesasrequiredby 117.430and117.435;(4)Documentingsupplierverificationactivitiesasrequiredby 117.475;and(5)Whenapplicable,verifyingasupply‐chain‐appliedcontrolappliedbyanentityotherthanthereceivingfacility’ssupplieranddocumentingthatverificationasrequiredby 117.475,orobtainingdocumentationofanappropriate

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verificationactivityfromanotherentity,reviewingandassessingthatdocumentation,anddocumentingthereviewandassessmentasrequiredby 117.475.

(b)Thefollowingareappropriatesupplierverificationactivitiesforrawmaterialsandotheringredients:(1)Onsiteaudits;(2)Samplingandtestingoftherawmaterialorotheringredient;(3)Reviewofthesupplier’srelevantfoodsafetyrecords;and(4)Otherappropriatesupplierverificationactivitiesbasedonsupplierperformanceandtheriskassociatedwiththerawmaterialorotheringredient.

(c)Thesupply‐chainprogrammustprovideassurancethatahazardrequiringasupply‐chain‐appliedcontrolhasbeensignificantlyminimizedorprevented.(d)(1)Exceptasprovidedbyparagraph(d)(2)ofthissection,inapprovingsuppliersanddeterminingtheappropriate

supplierverificationactivitiesandthefrequencywithwhichtheyareconducted,thefollowingmustbeconsidered:(i)Thehazardanalysisofthefood,includingthenatureofthehazardcontrolledbeforereceiptoftherawmaterialorotheringredient,applicabletotherawmaterialandotheringredients;(ii)Theentityorentitiesthatwillbeapplyingcontrolsforthehazardsrequiringasupply‐chain‐appliedcontrol;(iii)Supplierperformance,including:

(A)Thesupplier’sprocedures,processes,andpracticesrelatedtothesafetyoftherawmaterialandotheringredients;(B)ApplicableFDAfoodsafetyregulationsandinformationrelevanttothesupplier’scompliancewiththoseregulations,includinganFDAwarningletterorimportalertrelatingtothesafetyoffoodandotherFDAcomplianceactionsrelatedtofoodsafety(or,whenapplicable,relevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates,andinformationrelevanttothesupplier’scompliancewiththoselawsandregulations);and(C)Thesupplier’sfoodsafetyhistoryrelevanttotherawmaterialsorotheringredientsthatthereceivingfacilityreceivesfromthesupplier,includingavailableinformationaboutresultsfromtestingrawmaterialsorotheringredientsforhazards,auditresultsrelatingtothesafetyofthefood,andresponsivenessofthesupplierincorrectingproblems;and

(iv)Anyotherfactorsasappropriateandnecessary,suchasstorageandtransportationpractices.(2)Consideringsupplierperformancecanbelimitedtothesupplier’scompliancehistoryasrequiredbyparagraph(d)(1)(iii)(B)ofthissection,ifthesupplieris:

(i)Aqualifiedfacilityasdefinedby 117.3;(ii)Afarmthatgrowsproduceandisnotacoveredfarmunderpart112ofthischapterinaccordancewith 112.4(a),orinaccordancewith 112.4(b)and112.5;or(iii)Ashelleggproducerthatisnotsubjecttotherequirementsofpart118ofthischapterbecauseithaslessthan3,000layinghens.

(e)Iftheowner,operator,oragentinchargeofareceivingfacilitydeterminesthroughauditing,verificationtesting,documentreview,relevantconsumer,customerorothercomplaints,orotherwisethatthesupplierisnotcontrollinghazardsthatthereceivingfacilityhasidentifiedasrequiringasupply‐chain‐appliedcontrol,thereceivingfacilitymusttakeanddocumentpromptactioninaccordancewith 117.150toensurethatrawmaterialsorotheringredientsfromthesupplierdonotcausefoodthatismanufacturedorprocessedbythereceivingfacilitytobeadulteratedundersection402oftheFederalFood,Drug,andCosmeticActormisbrandedundersection403(w)oftheFederalFood,Drug,andCosmeticAct.§ 117.415 Responsibilities of the receiving facility. (a)(1)Thereceivingfacilitymustapprovesuppliers.

(2)Exceptasprovidedbyparagraphs(a)(3)and(4)ofthissection,thereceivingfacilitymustdetermineandconductappropriatesupplierverificationactivities,andsatisfyalldocumentationrequirementsofthissubpart.(3)Anentityotherthanthereceivingfacilitymaydoanyofthefollowing,providedthatthereceivingfacilityreviewsandassessestheentity’sapplicabledocumentation,anddocumentsthatreviewandassessment:

(i)Establishwrittenproceduresforreceivingrawmaterialsandotheringredientsbytheentity;(ii)Documentthatwrittenproceduresforreceivingrawmaterialsandotheringredientsarebeingfollowedbytheentity;and(iii)Determine,conduct,orbothdetermineandconducttheappropriatesupplierverificationactivities,withappropriatedocumentation.

(4)Thesuppliermayconductanddocumentsamplingandtestingofrawmaterialsandotheringredients,forthehazardcontrolledbythesupplier,asasupplierverificationactivityforaparticularlotofproductandprovidesuchdocumentationtothereceivingfacility,providedthatthereceivingfacilityreviewsandassessesthatdocumentation,anddocumentsthatreviewandassessment.

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(b)Forthepurposesofthissubpart,areceivingfacilitymaynotacceptanyofthefollowingasasupplierverificationactivity:

(1)Adeterminationbyitssupplieroftheappropriatesupplierverificationactivitiesforthatsupplier;(2)Anauditconductedbyitssupplier;(3)Areviewbyitssupplierofthatsupplier’sownrelevantfoodsafetyrecords;or(4)Theconductbyitssupplierofotherappropriatesupplierverificationactivitiesforthatsupplierwithinthemeaningof 117.410(b)(4).

(c)Therequirementsofthissectiondonotprohibitareceivingfacilityfromrelyingonanauditprovidedbyitssupplierwhentheauditofthesupplierwasconductedbyathird‐partyqualifiedauditorinaccordancewith 117.430(f)and117.435.§ 117.420 Using approved suppliers. (a)Approvalofsuppliers.Thereceivingfacilitymustapprovesuppliersinaccordancewiththerequirementsof 117.410(d),anddocumentthatapproval,beforereceivingrawmaterialsandotheringredientsreceivedfromthosesuppliers;(b)Writtenproceduresforreceivingrawmaterialsandotheringredients.

(1)Writtenproceduresforreceivingrawmaterialsandotheringredientsmustbeestablishedandfollowed;(2)Thewrittenproceduresforreceivingrawmaterialsandotheringredientsmustensurethatrawmaterialsandotheringredientsarereceivedonlyfromapprovedsuppliers(or,whennecessaryandappropriate,onatemporarybasisfromunapprovedsupplierswhoserawmaterialsorotheringredientsaresubjectedtoadequateverificationactivitiesbeforeacceptanceforuse);and(3)Useofthewrittenproceduresforreceivingrawmaterialsandotheringredientsmustbedocumented.

§ 117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity). Appropriatesupplierverificationactivities(includingthefrequencyofconductingtheactivity)mustbedeterminedinaccordancewiththerequirementsof 117.410(d).§ 117.430 Conducting supplier verification activities for raw materials and other ingredients. (a)Exceptasprovidedbyparagraph(c),(d),or(e)ofthissection,oneormoreofthesupplierverificationactivitiesspecifiedin 117.410(b),asdeterminedunder 117.410(d),mustbeconductedforeachsupplierbeforeusingtherawmaterialorotheringredientfromthatsupplierandperiodicallythereafter.(b)(1)Exceptasprovidedbyparagraph(b)(2)ofthissection,whenahazardinarawmaterialorotheringredientwillbe

controlledbythesupplierandisoneforwhichthereisareasonableprobabilitythatexposuretothehazardwillresultinseriousadversehealthconsequencesordeathtohumans:

(i)Theappropriatesupplierverificationactivityisanonsiteauditofthesupplier;and(ii)Theauditmustbeconductedbeforeusingtherawmaterialorotheringredientfromthesupplierandatleastannuallythereafter.

(2)Therequirementsofparagraph(b)(1)ofthissectiondonotapplyifthereisawrittendeterminationthatotherverificationactivitiesand/orlessfrequentonsiteauditingofthesupplierprovideadequateassurancethatthehazardsarecontrolled.

(c)Ifasupplierisaqualifiedfacilityasdefinedby 117.3,thereceivingfacilitydoesnotneedtocomplywithparagraphs(a)and(b)ofthissectionifthereceivingfacility:

(1)Obtainswrittenassurancethatthesupplierisaqualifiedfacilityasdefinedby 117.3:(i)Beforefirstapprovingthesupplierforanapplicablecalendaryear;and(ii)Onanannualbasisthereafter,byDecember31ofeachcalendaryear,forthefollowingcalendaryear;and

(2)Obtainswrittenassurance,atleastevery2years,thatthesupplierisproducingtherawmaterialorotheringredientincompliancewithapplicableFDAfoodsafetyregulations(or,whenapplicable,relevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates).Thewrittenassurancemustincludeeither:

(i)Abriefdescriptionofthepreventivecontrolsthatthesupplierisimplementingtocontroltheapplicablehazardinthefood;or(ii)AstatementthatthefacilityisincompliancewithState,local,county,tribal,orotherapplicablenon‐Federalfoodsafetylaw,includingrelevantlawsandregulationsofforeigncountries.

(d)Ifasupplierisafarmthatgrowsproduceandisnotacoveredfarmunderpart112ofthischapterinaccordancewith112.4(a),orinaccordancewith 112.4(b)and112.5,thereceivingfacilitydoesnotneedtocomplywithparagraphs(a)and(b)ofthissectionforproducethatthereceivingfacilityreceivesfromthefarmasarawmaterialorotheringredientifthereceivingfacility:

(1)Obtainswrittenassurancethattherawmaterialorotheringredientprovidedbythesupplierisnotsubjecttopart112ofthischapterinaccordancewith 112.4(a),orinaccordancewith 112.4(b)and112.5:

(i)Beforefirstapprovingthesupplierforanapplicablecalendaryear;and

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(ii)Onanannualbasisthereafter,byDecember31ofeachcalendaryear,forthefollowingcalendaryear;and(2)Obtainswrittenassurance,atleastevery2years,thatthefarmacknowledgesthatitsfoodissubjecttosection402oftheFederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates).

(e)Ifasupplierisashelleggproducerthatisnotsubjecttotherequirementsofpart118ofthischapterbecauseithaslessthan3,000layinghens,thereceivingfacilitydoesnotneedtocomplywithparagraphs(a)and(b)ofthissectionifthereceivingfacility:

(1)Obtainswrittenassurancethattheshelleggsproducedbythesupplierarenotsubjecttopart118becausetheshelleggproducerhaslessthan3,000layinghens:

(i)Beforefirstapprovingthesupplierforanapplicablecalendaryear;and(ii)Onanannualbasisthereafter,byDecember31ofeachcalendaryear,forthefollowingcalendaryear;and

(2)Obtainswrittenassurance,atleastevery2years,thattheshelleggproduceracknowledgesthatitsfoodissubjecttosection402oftheFederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates).

(f)Theremustnotbeanyfinancialconflictsofintereststhatinfluencetheresultsoftheverificationactivitieslistedin 117.410(b)andpaymentmustnotberelatedtotheresultsoftheactivity.§ 117.435 Onsite audit. (a)Anonsiteauditofasuppliermustbeperformedbyaqualifiedauditor.(b)IftherawmaterialorotheringredientatthesupplierissubjecttooneormoreFDAfoodsafetyregulations,anonsiteauditmustconsidersuchregulationsandincludeareviewofthesupplier’swrittenplan(e.g.,HazardAnalysisandCriticalControlPoint(HACCP)planorotherfoodsafetyplan),ifany,anditsimplementation,forthehazardbeingcontrolled(or,whenapplicable,anonsiteauditmayconsiderrelevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates).(c)(1)Thefollowingmaybesubstitutedforanonsiteaudit,providedthattheinspectionwasconductedwithin1yearof

thedatethattheonsiteauditwouldhavebeenrequiredtobeconducted:(i)ThewrittenresultsofanappropriateinspectionofthesupplierforcompliancewithapplicableFDAfoodsafetyregulationsbyFDA,byrepresentativesofotherFederalAgencies(suchastheUnitedStatesDepartmentofAgriculture),orbyrepresentativesofState,local,tribal,orterritorialagencies;or(ii)Foraforeignsupplier,thewrittenresultsofaninspectionbyFDAorthefoodsafetyauthorityofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates.

(2)ForinspectionsconductedbythefoodsafetyauthorityofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableordeterminedtobeequivalent,thefoodthatisthesubjectoftheonsiteauditmustbewithinthescopeoftheofficialrecognitionorequivalencedetermination,andtheforeignsuppliermustbein,andundertheregulatoryoversightof,suchcountry.

(d)Iftheonsiteauditissolelyconductedtomeettherequirementsofthissubpartbyanauditagentofacertificationbodythatisaccreditedinaccordancewithregulationsinpart1,subpartMofthischapter,theauditisnotsubjecttotherequirementsinthoseregulations.§ 117.475 Records documenting the supply‐chain program. (a)Therecordsdocumentingthesupply‐chainprogramaresubjecttotherequirementsofsubpartFofthispart.(b)Thereceivingfacilitymustreviewtherecordslistedinparagraph(c)ofthissectioninaccordancewith 117.165(a)(4).(c)Thereceivingfacilitymustdocumentthefollowinginrecordsasapplicabletoitssupply‐chainprogram:

(1)Thewrittensupply‐chainprogram;(2)Documentationthatareceivingfacilitythatisanimporterisincompliancewiththeforeignsupplierverificationprogramrequirementsunderpart1,subpartLofthischapter,includingdocumentationofverificationactivitiesconductedunder 1.506(e)ofthischapter;(3)Documentationoftheapprovalofasupplier;(4)Writtenproceduresforreceivingrawmaterialsandotheringredients;(5)Documentationdemonstratinguseofthewrittenproceduresforreceivingrawmaterialsandotheringredients;(6)Documentationofthedeterminationoftheappropriatesupplierverificationactivitiesforrawmaterialsandotheringredients;(7)Documentationoftheconductofanonsiteaudit.Thisdocumentationmustinclude:

(i)Thenameofthesuppliersubjecttotheonsiteaudit;(ii)Documentationofauditprocedures;(iii)Thedatestheauditwasconducted;(iv)Theconclusionsoftheaudit;

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(v)Correctiveactionstakeninresponsetosignificantdeficienciesidentifiedduringtheaudit;and(vi)Documentationthattheauditwasconductedbyaqualifiedauditor;

(8)Documentationofsamplingandtestingconductedasasupplierverificationactivity.Thisdocumentationmustinclude:

(i)Identificationoftherawmaterialorotheringredienttested(includinglotnumber,asappropriate)andthenumberofsamplestested;(ii)Identificationofthetest(s)conducted,includingtheanalyticalmethod(s)used;(iii)Thedate(s)onwhichthetest(s)wereconductedandthedateofthereport;(iv)Theresultsofthetesting;(v)Correctiveactionstakeninresponsetodetectionofhazards;and(vi)Informationidentifyingthelaboratoryconductingthetesting;

( )Documentationofthereviewofthesupplier’srelevantfoodsafetyrecords.Thisdocumentationmustinclude:(i)Thenameofthesupplierwhoserecordswerereviewed;(ii)Thedate(s)ofreview;(iii)Thegeneralnatureoftherecordsreviewed;(iv)Theconclusionsofthereview;and(v)Correctiveactionstakeninresponsetosignificantdeficienciesidentifiedduringthereview;

(10)Documentationofotherappropriatesupplierverificationactivitiesbasedonthesupplierperformanceandtheriskassociatedwiththerawmaterialorotheringredient;(11)Documentationofanydeterminationthatverificationactivitiesotherthananonsiteaudit,and/orlessfrequentonsiteauditingofasupplier,provideadequateassurancethatthehazardsarecontrolledwhenahazardinarawmaterialorotheringredientwillbecontrolledbythesupplierandisoneforwhichthereisareasonableprobabilitythatexposuretothehazardwillresultinseriousadversehealthconsequencesordeathtohumans;(12)Thefollowingdocumentationofanalternativeverificationactivityforasupplierthatisaqualifiedfacility:

(i)Thewrittenassurancethatthesupplierisaqualifiedfacilityasdefinedby 117.3,beforeapprovingthesupplierandonanannualbasisthereafter;and(ii)ThewrittenassurancethatthesupplierisproducingtherawmaterialorotheringredientincompliancewithapplicableFDAfoodsafetyregulations(or,whenapplicable,relevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates);

(13)Thefollowingdocumentationofanalternativeverificationactivityforasupplierthatisafarmthatsuppliesarawmaterialorotheringredientandisnotacoveredfarmunderpart112ofthischapter:

(i)Thewrittenassurancethatsupplierisnotacoveredfarmunderpart112ofthischapterinaccordancewith 112.4(a),orinaccordancewith 112.4(b)and112.5,beforeapprovingthesupplierandonanannualbasisthereafter;and(ii)Thewrittenassurancethatthefarmacknowledgesthatitsfoodissubjecttosection402oftheFederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsandregulationsofacountrywhosefoodsafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates);

(14)Thefollowingdocumentationofanalternativeverificationactivityforasupplierthatisashelleggproducerthatisnotsubjecttotherequirementsestablishedinpart118ofthischapterbecauseithaslessthan3,000layinghens:

(i)Thewrittenassurancethattheshelleggsprovidedbythesupplierarenotsubjecttopart118ofthischapterbecausethesupplierhaslessthan3,000layinghens,beforeapprovingthesupplierandonanannualbasisthereafter;and(ii)Thewrittenassurancethattheshelleggproduceracknowledgesthatitsfoodissubjecttosection402oftheFederalFood,Drug,andCosmeticAct(or,whenapplicable,thatitsfoodissubjecttorelevantlawsandregulationsofacountrywhosesafetysystemFDAhasofficiallyrecognizedascomparableorhasdeterminedtobeequivalenttothatoftheUnitedStates);

(15)ThewrittenresultsofanappropriateinspectionofthesupplierforcompliancewithapplicableFDAfoodsafetyregulationsbyFDA,byrepresentativesofotherFederalAgencies(suchastheUnitedStatesDepartmentofAgriculture),orbyrepresentativesfromState,local,tribal,orterritorialagencies,orthefoodsafetyauthorityofanothercountrywhentheresultsofsuchaninspectionissubstitutedforanonsiteaudit;(16)Documentationofactionstakenwithrespecttosuppliernon‐conformance;(17)Documentationofverificationofasupply‐chain‐appliedcontrolappliedbyanentityotherthanthereceivingfacility’ssupplier;and(18)Whenapplicable,documentationofthereceivingfacility’sreviewandassessmentof:

(i)Applicabledocumentationfromanentityotherthanthereceivingfacilitythatwrittenproceduresforreceivingrawmaterialsandotheringredientsarebeingfollowed;

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(ii)Applicabledocumentation,fromanentityotherthanthereceivingfacility,ofthedeterminationoftheappropriatesupplierverificationactivitiesforrawmaterialsandotheringredients;(iii)Applicabledocumentation,fromanentityotherthanthereceivingfacility,ofconductingtheappropriatesupplierverificationactivitiesforrawmaterialsandotheringredients;(iv)Applicabledocumentation,fromitssupplier,of:

(A)Theresultsofsamplingandtestingconductedbythesupplier;or(B)Theresultsofanauditconductedbyathird‐partyqualifiedauditorinaccordancewith 117.430(f)and117.435;and

(v)Applicabledocumentation,fromanentityotherthanthereceivingfacility,ofverificationactivitieswhenasupply‐chain‐appliedcontrolisappliedbyanentityotherthanthereceivingfacility’ssupplier.

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NOTES:

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Appendix 2. Food Safety Plan Worksheets Worksheetsarerecommendedtodocumenttheproductdescription,hazardanalysisandpreventivecontrols.Thehazardanalysisformshouldcontaininformationtojustifytheidentificationofthehazardsrequiringpreventivecontrolsandthetypesofpreventivecontrolsapplied.InformationintheFoodSafetyPlanmustexplainthedetailsforeachpreventivecontrol.

Thereisnostandardizedormandatedformatfortheseworksheets,buttheinformationshouldbearrangedinaprogressivemannerthatclearlyexplainsthethoughtprocessforthehazardanalysisandtheindividualstepsintheFoodSafetyPlan.Formsusedforprocesspreventivecontrolsmaybeadaptedforallergenpreventivecontrols,butotherformatsareentirelyacceptableifitworksforyourorganizationandcontainsalloftherequiredinformation.

Thefollowingworksheetsareprovidedasexamples.Theinformationisarrangedinasimilarmanner,butthelayoutsareineitheralandscapeoraportraitformtosuitindividualpreferences.OtherformscanbeadaptedfromthoseintheFoodSafetyPlanexample.

SpecialNote:Theseworksheetscanbecopiedforroutineuse,butiftheyareusedforofficialuse,theymustincludedetailsthatidentifythecommercialfirmandrelatedinformation.Theadditionalinformationmustinclude:

x Firmnameandlocation

x Datesand,whenappropriate,thetimeoftheactivity

x Productidentification

x Usually,recordreviewsignature(orinitial)anddate

All forms can be adapted or modified as needed. There is NO required form.

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

ProductDescriptionDistribution,ConsumersandIntendedUseProductName(s)

ProductDescription,includingImportantFoodSafetyCharacteristics

Ingredients

PackagingUsed

IntendedUse

IntendedConsumers

ShelfLife

LabelingInstructionsrelatedtoSafety

StorageandDistribution

Approved:Signature:Printname:

Date:

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS SUPERSEDES

PRODUCTCODE

Hazard identification (column 2) considers those that may be present in the food because the hazard occurs naturally, the hazard may be unintentionally introduced, or the hazard may be intentionally introduced for economic gain.

B = Biological hazards including bacteria, viruses, parasites, and environmental pathogens C = Chemical (including radiological) hazards, food allergens, substances such as pesticides and drug residues, natural

toxins, decomposition, and unapproved food or color additives P = Physical hazards include potentially harmful extraneous matter that may cause choking, injury or other adverse health

effects

Hazard Analysis

(1)

Ingredient / Processing

Step

(2)

Identify potential food safety hazards

introduced, controlled or

enhanced at this step

(3) Do any potential food safety hazards require a preventive control?

(4) Justify your decision for

column 3

(5) What preventive control

measure(s) can be applied to significantly minimize or prevent the food safety

hazard? Process including CCPs, Allergen, Sanitation, Supply‐chain, other

preventive control

(6) Is the

preventive control

applied at this step?

Yes No Yes No

B

C

P

B

C

P

B

C

P

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

ProcessPreventiveControls–LandscapeLayout

Records

Verification

Correctiv

e Ac

tion

Mon

itorin

g

Who

Freq

uency

How

Wha

t

Parameters,

values or

critical lim

its

Hazard(s)

Process

Controls

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

ProcessPreventiveControls–PortraitFormatThisisanalternatelayoutforprocesspreventivecontrol.

Process Control Step

Hazard(s)

Parameters, values or critical limits

Monitoring

What

How

Frequency

Who

Corrective Action

Verification

Records

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

Form

Name:FoodAllergenPreventiveControls

Records

Verification

Correctiv

e Ac

tion

Mon

itorin

g

Who

Freq

uency

How

Wha

t

Crite

rion

Hazard(s)

Allergen

Co

ntrol

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

FormName:FoodAllergenIngredientAnalysis

RawMaterialName Supplier

FoodAllergensinIngredientFormulation

Allergensin

Precautionary

Labeling

Egg

Milk

Soy

Wheat

TreeNut

(marketnam

e)Peanut

Fish

(marketnam

e)Shellfish

(marketnam

e)

NOTE: The above format is an alternative for an allergen specific hazard analysis. If you choose to use a form like this, then there is no need to duplicate allergen considerations in your hazard analysis chart. Duplication of information in multiple forms can create extra work and may lead to inconsistencies.

Some organizations may even choose to do an ingredient hazard analysis that considers not only allergens, but also other hazards. This may be a useful option for you.

How to Use the Chart List all ingredients received in the facility. Identify allergens contained in each ingredient by reviewing ingredient labels or contacting the manufacturer. Any allergens listed in “May contain” or other precautionary labeling on ingredients should be listed in the last column and reviewed to determine if allergen labeling is needed on the finished product.

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

FormName:FoodAllergenLabelVerificationListingProduct AllergenStatement

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

FormName:ProductionLineFoodAllergenAssessment

ProductName ProductionLine

IntentionalAllergens

Egg

Milk

Soy

Wheat

TreeNut

(marketnam

e)

Peanut

Fish

(marketnam

e)

Shellfish

(marketnam

e)

SchedulingImplications:

AllergenCleaningImplications:(Required)

How to Use This Form Complete for each production line. Identify each allergen contained in each product produced on the line. Identify any allergens unique to a specific product, then indicate scheduling information (i.e., run unique allergens last) and allergen cleaning information (i.e., full allergen clean before running cheese or plain omelets after a biscuit run.

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

FormName:SanitationPreventiveControlsLocation Purpose Frequency Who Procedure Monitoring Corrections Records Verification Date

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

CorrectiveActionForm

DateofRecord: CodeorLotNumber:

DateandTimeofDeviation:

DescriptionofDeviation:

ActionsTakentoRestoreOrdertotheProcess:

Person(nameandsignature)ofPersonTakingAction:

AmountofProductInvolvedinDeviation:

EvaluationofProductInvolvedwithDeviation:

FinalDispositionofProduct:

Reviewedby(NameandSignature): DateofReview:

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PLANTNAME

ISSUEDATE

PAGE

ADDRESS

SUPERSEDES

PRODUCTCODE

FoodSafetyPlanReanalysisChecklistReasonforreanalysis:

Task

DateReviewed

andInitials

IsUpdateNeeded (yes/no)

DateTaskCompleted

SignatureorInitialsofPersonCompletingtheTask

ListofFoodSafetyTeamwithindividualresponsibilities

Productflowdiagrams

Hazardanalysis

ProcessPreventiveControls

FoodAllergenPreventiveControls

SanitationPreventiveControls

Supply‐chainProgram

RecallPlan

UpdatedFoodSafetyPlanimplemented

UpdatedFoodSafetyPlansignedbyowneroragentincharge

ReviewerSignature: DateReview:

Dateissued:dd/mm/yy Supersedes:dd/mm/yy

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PRODUCT(S) Omelet – Plain, Cheese and Cheese Biscuit PAGE 1 of 38 PLANT NAME: E.G. Food Company ISSUE DATE 2/13/2016 ADDRESS: 360 Culinary Circle, Mytown, USA SUPERSEDES 09/20/2015

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Appendix 3: Model Food Safety Plan Teaching Example

Food Safety Plan for

Frozen Omelets Reviewed by: I.N. Charge, Plant Manager

Date: February 13, 2016

.The information in this example is for training purposes only and does not represent any specific operation. Development of a Food Safety Plan is site specific, thus it is highly unlikely that this plan can be adapted to

another operation without significant modification. This teaching model includes required and optional information to illustrate how a Food Safety Plan might be documented. The format may vary significantly for each specific company.

x The Background Information section is not required, but is highly useful for organizing the plan and explaining its organization to others. It is essential for a teaching example to clarify underlying assumptions in decisions that are made.

x The Hazard Analysis section is required for all Food Safety Plans subject to the Preventive Controls for Human Food regulation.

x The Preventive Controls sections (Process, Allergen, Sanitation and Supply-chain) are required ONLY for hazards requiring a preventive control identified by the hazard analysis.

x A Recall Plan is required ONLY when a hazard requiring a preventive control is identified by the hazard analysis.

x Implementation Records are required only for hazards requiring a preventive control.

o A validation study is required only for process preventive controls.

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Table of Contents Background Information ................................................................................................................ 3

Company Overview and Food Safety Team ............................................................................. 3Product Description, Distribution, Consumers and Intended Use ............................................. 4Flow Diagram ............................................................................................................................ 5Process Description .................................................................................................................. 6

Hazard Analysis ............................................................................................................................ 9Process Preventive Control ........................................................................................................ 13

Cook ........................................................................................................................................ 13Cook Validation Study ......................................................................................................... 14Product Testing for Verification ............................................................................................ 15

Metal detection ........................................................................................................................ 17Allergen Preventive Control ........................................................................................................ 18

Ingredient Allergen Identification ............................................................................................. 18Allergen Label Declaration ...................................................................................................... 19Allergen Verification Listing ..................................................................................................... 20Allergen Scheduling and Cleaning Implications ...................................................................... 20

Sanitation Preventive Control ..................................................................................................... 21Assemble/Wrap Table Sanitation ............................................................................................ 21Assemble/Wrap Environmental Sanitation .............................................................................. 22Assemble/Wrap Hygienic Zoning ............................................................................................ 23

Environmental Monitoring for Sanitation Preventive Control Verification ............................ 24Supply-chain Preventive Controls Program ................................................................................ 25

Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control ....................... 25Receiving Procedure for Ingredients Requiring a Supply-chain-applied Control ..................... 25Determination of Verification Procedures ................................................................................ 26

Recall Plan .................................................................................................................................. 27Implementation Records ............................................................................................................. 27

Monitoring Records Forms ...................................................................................................... 28Cook Log ............................................................................................................................. 28Metal Detection Log ............................................................................................................. 29Allergen Label Check Log .................................................................................................... 30Allergen Run Order Record ................................................................................................. 31Daily Sanitation Control Record – Omelet Line ................................................................... 32

Corrective Action Records ....................................................................................................... 33Verification Records ................................................................................................................ 34

Daily Thermometer Accuracy Check ................................................................................... 35Annual Thermometer Calibration Log .................................................................................. 36Receiving Log ...................................................................................................................... 37Supplier Audit Verification .................................................................................................... 37Food Safety Plan Reanalysis Report ................................................................................... 38

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BackgroundInformation

Company Overview and Food Safety Team E.G. Food Company’s ~150 employees produce egg-based products, including plain omelets, cheese omelets and cheese omelet biscuits. Product is made 5 days a week in one 8 hour production shift, followed by 4 hours for sanitation. Cleaning and sanitizing of all processing equipment is conducted per a master sanitation schedule, which also includes cleaning and sanitizing between different products if needed for allergen control. Municipal water, which is treated and tested per EPA requirements by the city, is used throughout the facility. The company practices hygienic zoning to prevent cooked product exposure to environmental pathogens and employees working in the high hygiene areas wear color coded smocks and dedicated footwear. These employees are instructed on proper hand washing procedures, glove use, and importance of zoning.

Food Safety Team

Name Position Training (Records are in personnel file)

I.N. Charge Plant Manager In plant training

F.S. Leader* QA manager and food safety team leader

FSPCA class

E.F. Ency Production supervisor In plant training

I.M. Clean Sanitation supervisor In plant training

P.H. Books* Consultant, PH Books Consulting Service

M.S. & Ph.D. in Food Science and FSPCA lead instructor

*Preventive controls qualified individual

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Product Description, Distribution, Consumers and Intended Use Product Name(s) Omelet – Plain, Cheese and Cheese Biscuit

Product Description, including Important Food Safety Characteristics

Frozen, cooked egg omelet, with or without cheese filling and a wheat biscuit bun pH 7.1 - 7.9, water activity >0.98, no preservatives

Ingredients Plain: Eggs, milk, pan release oil, salt Cheese: Eggs, milk, cheese, pan release oil, salt Cheese Biscuit: Eggs, milk, cheese, biscuit, pan release oil, salt

Packaging Used Paperboard trays wrapped with plastic wrap and inserted in a corrugated case.

Intended Use The product is considered ready-to-eat, but is typically heated to hot holding temperatures (135°F (57°C)) or above for palatability. Heating is typically conducted using microwaves or convection oven. End user may thaw at refrigeration temperatures overnight to reduce cooking time. End users may also add toppings or fillings. Sold for foodservice applications. Potential abuse: Some establishments may hold thawed product for longer than the recommended 24 hours.

Intended Consumers General public Shelf Life 1 year frozen Labeling Instructions Keep frozen or thaw under refrigeration (<41°F (5°C)) for

<24 hours before cooking. Storage and Distribution Frozen Approved:* Signature: F.S. Leader Print name: F.S. Leader

Date: April 11, 2015

*Signature may just be on plan, or may be on each page.

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Flow Diagram

Receiving packaging

[labeled carton, tray, plastic wrap]

Receiving shelf

stable ingredients [pan release oil, salt]

Receiving refrigerated

ingredients [liquid pasteurized eggs, pasteurized milk, cheese]

Receiving frozen ingredients

[prebaked biscuits]

p p p p Packaging

storage [labeled carton, tray,

plastic wrap]

Ambient ingredient storage

[pan release oil, salt]

Refrigerated ingredient storage [liquid pasteurized eggs, pasteurized milk, cheese]

Frozen ingredient storage

[prebaked biscuits]

p p Labeled carton

assembly Mix ingredients

[liquid pasteurized eggs, pasteurized milk, salt]

p

Cook

[liquid pasteurized eggs, pasteurized milk, salt, pan

release oil]

m

p

Assemble, wrap tray [Cheese or biscuit may be

added]

m

p Spiral freeze p Metal detection p Fill, weigh, label p Frozen storage p Frozen distribution

NOTE: Text in [square brackets] optional and for teaching purposes

Verified by: F.S. Leader April 11, 2015

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Process Description This Process Narrative was developed for teaching purposes to create a common vision of this hypothetical process among course participants. There is no requirement for an establishment to create such a document; however, a Process Narrative may be useful to guide hazard analysis and to orient auditors. Other company documents outside of the Food Safety Plan may substitute for a Process Narrative, such as ingredient specifications, product specifications, production instructions, standard operating procedures, etc. This Process Narrative does not represent any existing process.

Receiving Ingredients and Packaging:

Ingredients and raw materials are purchased from reputable suppliers that comply with internationally recognized food safety and quality systems. For each ingredient, the same brand is used consistently to minimize variation. Ingredients are stored according to manufacturers’ recommendations when specified.

x Receiving packaging: Corrugated shippers, paperboard trays and plastic wrap are received in bulk. Specifications require food grade material for trays and plastic wrap that is compatible with frozen storage of food products. Labeled cartons are reviewed for conformance with product allergen requirements and ingredients.

x Receiving shelf stable ingredients: o Salt: Received in 10-pound bags from our distributor. Specifications require food

grade salt. o Pan release oil: The pan release oil contains soybean oil, soy lecithin and natural

flavor. It is received from our distributor in 10-gallon jugs. x Receiving refrigerated ingredients:

o Eggs: Refrigerated, pasteurized liquid eggs, processed to meet USDA requirements, are received in 20-pound, bag-in-box containers from our sole source supplier, in refrigerated trucks.

o Milk: Pasteurized Grade A milk is received from a local dairy in 20-pound bag-in-crate containers in refrigerated trucks. The supplier’s letter of guarantee states that production practices are in compliance with Pasteurized Milk Ordinance requirements for pasteurized milk products, including animal drug residue testing.

o Cheese: Pre-sliced, pasteurized process cheese is received in 3-pound cases from our sole source supplier. The cheese contains cultured pasteurized milk and skim milk, buttermilk, milkfat, salt, sodium phosphate, tricalcium phosphate, lactic acid, milk protein concentrate, artificial color, and enzymes.

x Receiving frozen ingredients: o Biscuits: Pre-sliced, wheat biscuits are received frozen in 16-pound cases (5 trays of

20 biscuits per case) from our distributor. The biscuits contain enriched bleached flour (wheat flour, niacin, iron, thiamine mononitrate, riboflavin, folic acid), water, shortening (palm oil, mono and diglycerides, polysorbate 60, citric acid), buttermilk solids, sugar, baking powder (sodium acid pyrophosphate, sodium bicarbonate, cornstarch, calcium sulfate, monocalcium phosphate), and salt.

Storing Ingredients and Packaging:

x Packaging storage: Labeled cartons and trays are stored in the dry storage room in the packaging area. Plastic wrap is stored in sealed containers to protect from contamination. Packaging is used First-In-First-Out.

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x Ambient ingredient storage: Salt and pan release oil are stored in the dry storage room in the ingredient area, arranged by ingredient code number. All containers are sealed to avoid allergen cross-contact and cross-contamination during storage. Ingredients containing food allergens are identified and stored in specific locations with like allergenic ingredients, unless allergen cross-contact is not reasonably likely to occur.

x Refrigerated ingredient storage: Pasteurized liquid eggs and pasteurized fluid milk are stored in separate designated areas in a cooler that is kept at ≤40°F (≤4.4°C) and used within code date. No open containers are returned to the cooler to minimize the potential for allergen cross-contact with either milk or egg allergens.

x Frozen ingredient storage: Frozen biscuits are stored in a designated area separate from finished goods storage. The freezer is maintained at <0°F (-18°C). A partially used case may be resealed and returned to the freezer after use on the line.

Mix ingredients: Eggs, milk and salt are combined in the mixing room using a commercial mixer with a wire whip. The batch size is used within 30 minutes. The temperature of the omelet batter is ≤40°F (≤4.4°C) after mixing. Mixing bowls are taken to the cook line for dispensing. Bowls are moved to a separate room for cleaning at the morning break, at lunch break and after the shift.

Cook: Pan-release oil is used to grease the omelet pans as needed to prevent sticking. Approximately one cup of omelet batter is deposited manually into omelet pans on high heat setting. The pan is swirled and edges of the omelet are lifted with a spatula to allow uncooked (liquid) batter to flow under the cooked portion. Surface temperatures (the coolest point) are periodically measured with an infrared thermometer and are typically >162°F (72°C) when the omelet is fully congealed, the surface is not shiny and thus cooking is complete. A congealed omelet is required to enable assembly. All omelet batter prepared is cooked or discarded – there is no rework.

Assemble, wrap: Cooked omelets are transferred to a table with the cooking spatula. The same table is used to assemble all products.

x Plain omelets are folded or rolled by hand to desired shape. Plain omelets are the first product made each day.

x Cheese omelet production begins after plain omelet numbers have been prepared. Cheese is brought to the line just in time for production in sufficient quantity to be used in <2 hours. Plain omelets are prepared, and a slice of cheese is placed in the center of the omelet prior to folding or rolling. All cheese is used for product or very small amounts are discarded at the end of the day.

x Cheese biscuit omelets are the last item made each day and only prepared when orders require. The required number of biscuits is brought to the line and trays containing 20 biscuits each placed on assembly tables. A folded plain omelet is placed on the bottom biscuit half, a slice of cheese is placed on the omelet, which is then topped with the biscuit top. All biscuit trays removed from a case are used for production or discarded at the end of the day. A partial case (i.e., 1-4 full trays) may be resealed, dated, returned to the freezer and used for the next production.

Twelve (12) omelets or six (6) cheese biscuit omelets are placed on a tray and plastic wrap is applied to cover the tray. Packaging does not reduce the oxygen level.

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A3‐8

Spiral freeze: Wrapped trays are placed on a belt that carries the omelets though a spiral freezer. Freezing takes place rapidly, with temperatures dropping from >135°F (57°C) to <41°F (5°C) in <1 hour from the time the omelet is placed on the assembly table. Product exiting freezer is frozen solid, with temperatures continuing to drop to <10°F (-12°C) in frozen storage.

Metal detection: Frozen product in trays is passed through a metal detector. All rejected product is examined for the presence of metal.

Labeled carton assembly: Labeled cartons are assembled as needed at the ‘Fill, Weigh, Label’ step.

Fill, weigh, label: Four trays of frozen omelets are placed in labeled cartons. Labeled cartons are weighed and sealed, and the lot code is applied. This step takes place in <30 minutes for each case.

Frozen storage: Finished product is stored at <10°F (-12°C) until distributed.

Frozen shipping: Product is shipped in freezer trucks to customers at <10°F (-12°C).

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A3‐9

HazardAnalysisHazard identification (column 2) considers those that may be present in the food because the hazard occurs naturally, the hazard may be unintentionally introduced, or the hazard may be intentionally introduced for economic gain.

B = Biological hazards including bacteria, viruses, parasites, and environmental pathogens C = Chemical (including radiological) hazards, food allergens, substances such as

pesticides and drug residues, natural toxins, decomposition, and unapproved food or color additives

P = Physical hazards include potentially harmful extraneous matter that may cause choking, injury or other adverse health effects

(1) Ingredient/ Processing

Step

(2) Identify potential food safety hazards



(3) Do any

potential food safety hazards

require a preventive control?

(4) Justify your decision for column 3




preventive control

(6) Is the

preventive control


Yes No Yes No Receiving packaging

B None C Undeclared allergens – egg, milk, soy (wheat in biscuit only)

X Labeled cartons must declare allergens present in the product and print errors have occurred

Allergen Control – label review for allergen information

X

P None Receiving shelf stable ingredients – salt

B None C None P None

Receiving shelf stable ingredients – pan release oil

B None C Allergen – soy X Soy lecithin may contain soy

allergen that must be labeled to inform consumers. Allergen cross‐contact is not an issue – all products contain soy.

Allergen Control – allergen labeling at other steps

X

P None Receiving refrigerated ingredients – liquid pasteurized eggs

B Vegetative pathogens such as Salmonella

X While pasteurization minimizes the likelihood of Salmonella USDA recommends the product be used in cooked foods. Experience has shown Salmonella occasionally occurs in this ingredient.

Process Control ‐ subsequent cook step

X

C Allergen – egg X Egg is an allergen that must be labeled to inform consumers. Allergen cross‐contact is not an issue – all products contain egg.


X

Continued P None

NOTE: Label review could be done only at the labeling step, but many organizations perform this upon receipt because individuals with different skills are needed.

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A3‐10


Step




(3) Do any







preventive control

(6) Is the

preventive control


Yes No Yes No Receiving refrigerated ingredients – pasteurized Grade A milk


X Raw milk has a history of association with Salmonella. Pasteurization by the supplier or our cook step can control the hazard.

Process Control ‐ subsequent cook step

X

C Allergen – milk X Milk is an allergen that must be labeled to inform consumers. Allergen cross‐contact is not an issue – all products contain milk.


X

P None Receiving refrigerated ingredients – pasteurized process cheese

B Vegetative and sporeforming pathogens such as Salmonella, pathogenic E. coli, L. monocytogenes and C. botulinum

X Pathogens listed were identified as significant by ICMSF (2005) in process cheese. These hazards must be controlled when the cheese is made.

Supply‐chain Control – approved supplier and 3rd party supplier audit by a qualified auditor

X

C Allergen – milk X Milk is an allergen that must be labeled to inform consumers. Allergen cross‐contact is not an issue – all products contain milk.


X

P None Receiving frozen ingredients – biscuits

B None C Allergen ‐ wheat X Wheat is an allergen that

must be labeled to inform consumers. Allergen cross‐contact with other products must be controlled because some products produced on the line do not contain wheat.

Allergen Control – allergen labeling at other steps Sanitation Control – at a subsequent step to prevent allergen cross‐contact

X

P None Storage – Pack‐aging & dry ingredients [pan release oil, salt]


Continued

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A3‐11


Step




(3) Do any







preventive control

(6) Is the

preventive control


Yes No Yes No Refrigerated ingredient storage [eggs, milk]


X Pathogen growth to levels that render the cook step ineffective is not likely to occur

C None P None

Frozen ingredient storage [biscuits]


Labeled carton assembly


Mix ingredients [eggs, milk, salt]

B None C None P Metal X Mixer has metal‐on‐metal

contact Process Control – subsequent metal detection

X

Cook [eggs, milk, salt, pan release oil]

B Survival of vegetative pathogens such as Salmonella

X Thorough cooking is required to kill vegetative pathogens

Process Control – cooking to achieve a lethal temperature

X

C None P None

Assemble, wrap

B Introduction of environmental pathogens such as L. monocytogenes

X Recontamination may occur if sanitation controls are not in place

Sanitation Controls – prevent recontamination

X

Growth of vegetative pathogens such as Salmonella and L. monocytogenes

X Time is too short for growth to be reasonably likely.

C Allergen cross‐contact from other products handled at this step; e.g., Cheese Omelet Biscuit

X Biscuits could introduce wheat allergen to other products without control

Sanitation and Allergen Controls – prevent allergen cross‐contact

X

P None Continued

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A3‐12


Step




(3) Do any







preventive control

(6) Is the

preventive control


Yes No Yes No Spiral freeze B Growth of

vegetative pathogens such as Salmonella and L. monocytogenes

X Time is too short for growth to be reasonably likely

C None P None

Metal detection

B None C None P Metal X Metal‐on‐metal contact on

the line may introduce metal fragments

Process Control – metal detection

X

Fill, weigh, label

B None C Undeclared allergens – egg, milk, soy (wheat in biscuit only)

X All products contain egg, milk and soy allergens. The cheese biscuit also contains wheat

Allergen Control – correct labeled carton for product

X

P None Frozen storage


Frozen distribution


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A3‐13

ProcessPreventiveControlR

ecor

ds

Coo

k Lo

g –

cook

tem

p by

QA

te

chni

cian

Cor

rect

ive

Act

ion

reco

rds

Ver

ifica

tion

reco

rds,

in

clud

ing

valid

atio

n st

udy

Verif

icat

ion

Rev

iew

of

Coo

k Lo

g,

Cor

rect

ive

Act

ion

and

Ver

ifica

tion

reco

rds

with

in 7

w

orki

ng d

ays

Dai

ly

accu

racy

ch

eck

for

ther

mom

eter

Ann

ual

calib

ratio

n of

th

erm

omet

er

Cor

rect

ive

Act

ion

Hol

d pr

oduc

t ba

ck to

the

last

goo

d ch

eck

and

eval

uate

–

rew

ork,

di

scar

d, o

r re

leas

e.

Det

erm

ine

root

cau

se

– re

train

or

corr

ect a

s ap

prop

riate

Mon

itorin

g W

ho

QA

te

chni

cian

or

de

sign

ee

Freq

uency

Eac

h co

ok

stat

ion,

4

times

per

sh

ift,

abou

t ev

ery

2-3

hour

s

How

Infra

red

surfa

ce

ther

mo-

met

er

Wha

t O

mel

et

surfa

ce

tem

per

-atu

re

is

≥158

°F

(70°

C)

Crit

ical

Li

mits

O

mel

et

tem

pera

ture

is

≥15

8°F

(70°

C)

inst

anta

ne‐

ous

befo

re

trans

fer t

o as

sem

bly

tabl

e

Haz

ard(

s)

Veg

etat

ive

path

ogen

s su

ch a

s S

alm

onel

la

Proc

ess

Con

trol

Coo

k

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A3‐14

Cook Validation Study

P.H. Books Consulting Services 123 Research Way, Infoville USA

E.G. Food Company Omelet Cook Validation Study

Determination of lethal cook temperatures for Salmonella in egg products Section 3‐401.11 (A) (2) of the Food Code (a credible source for science‐based recommendations) identifies the following time and temperature combinations as adequate for cooking raw egg‐containing products: x 145°F(63°C) for 3 minutes x 150°F(66°C) for 1 minute x 155°F(68°C) for 15 seconds x 158°F(70°C) for <1 second (instantaneous)

Conclusion: A critical limit of t158°F (70°C) for <1 second (instantaneous) will effectively manage the risk of Salmonella in omelets based on the Food Code. Use of pasteurized eggs adds an extra margin of safety.

Determination that a congealed omelet is a valid visual cue for achieving a lethal temperature It is well established that coagulation of eggs protein is a function of temperature. Lowe1 reported that whole egg coagulates at 158°F (70°C), but commented that addition of milk can elevate the coagulation temperature. Stadelman and Cotterill2 also discuss the influence of non‐egg components on elevation of coagulation temperature. Therefore a study was conducted to determine temperatures achieved when omelets coagulated under routine operating conditions and to determine the frequency of temperature measurements.

A calibrated infrared thermometer was used to measure the temperature of the surface of omelets when they were cooked to desired doneness by 10 operators – 5 omelets for each of 10 operators on 3 separate days, for a total of 150 measurements. The omelet batter for each of the 3 separate days used different lots of eggs and milk. Omelets were prepared using standard procedures – one cup of omelet batter was deposited into oiled omelet pans on the high heat setting. Each pan was swirled and edges of the omelet were lifted with a spatula to allow uncooked (liquid) batter to flow under the cooked portion until coagulation was complete, no liquid batter is present, and the surface is no longer shiny.

Conclusion: The minimum temperature observed was 162°F (72°C), which is more than adequate to assure temperatures are above the critical limit of t158°F (70°C). The maximum temperature observed was 170°F (77°C). Temperatures will be monitored four (4) times per shift to provide ongoing documentation.

Signed: P.H. Books Date: 9 September 2014 Principle Consultant

_____________________

1 Lowe, B. 1937. Experimental Cookery from the Chemical and Physical Standpoint. John Wiley & Sons. Egg section available at http://chestofbooks.com/food/science/Experimental-Cookery/index.html#.UqoI39vnYiR Accessed 12 December 2013

2 Stadelman, W.J. and O.J. Cotterill (eds). 1995 Egg Science and Technology, 4th Edition, Haworth Press, Inc., Binghamton NY.

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A3‐15

Product Testing for Verification

Purpose: To verify the adequacy of process control (cooking) for the hazard of Salmonella and the adequacy of sanitation controls to prevent recontamination.

Sample identification: Whole omelets at the assembly table prior to packaging and freezing are sampled. Results from the omelets sampled represent one day of production because cleaning and sanitizing occurs daily.

Sampling procedure: Once per month, five (5) omelets are randomly selected throughout the day. Each omelet is from a different assembly station. Individual omelets are aseptically collected, placed in sterile, plastic sample bags, which are labeled with the date, time, product type, lot number and operator number. Samples are placed on a tray, which is run through the spiral freezer to mimic processing conditions. The frozen omelets are sent to our contract lab, identified below, in an insulated cooler with an ice pack using overnight express mail.

Product from the sampled lot is held until results are received and confirmed to be in compliance with acceptance criteria identified under “Results” below.

Laboratory: Wee Beasties Laboratory (987 Critter Drive, Yourtown, USA)

Test conducted: The contract lab samples a portion from each omelet and retains the remaining sample under refrigeration for further testing if results are not acceptable. Each portion is tested individually for Enterobacteriaceae. Of the 5 samples taken, 2 can have results between 10 and 100/g. No individual sample can have a count greater than 100/g.

Microorganism Analytical Method Sampling plan Limits/g

n c m M

Enterobacteriaceae AOAC 2003.1 5 2 10 100

n = number of sample units c = number of sample units that can have results between m and M m = concentration separating good from marginally acceptable results M = concentration separating marginally acceptable from unacceptable results

Interpretation of results: Acceptable results – Release product if either of the following are observed

1. All results are ≤10/g 2. 1 or 2 results between 10 and 100/g; all others ≤10/g

Unacceptable results – Apply corrective action if either of the following are observed 1. More than 2 samples have results between 10 and 100 2. One or more results >100/g

Corrective action for unacceptable results: 1. Determine the disposition of the lot (day’s production) by testing 25g from each of the

five (5) retained omelets for Salmonella and Listeria monocytogenes. Product is on hold and release status until negative results are confirmed.

a. If no pathogen is detected – Release the product and implement other corrective actions below

b. If either pathogen is detected – Divert the product to rendering and implement other corrective actions

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A3‐16

2. Determine root cause a. Increase observation of cooking procedures and temperature verification at the

Cook step to hourly. i. Observe assembly tables for signs of uncooked egg (e.g., liquid egg

smears on the tables), which indicates undercooking and will remain and build throughout the day. Focus especially on tables that had the higher counts in the lab results.

ii. Retrain cooking staff if issues are noted. b. Conduct stringent sanitation efforts in the Assemble/Wrap, Cook and hallway

between these areas. Increase observation of cleaning procedures at the end of the day and before start up to identify issues. Also observe procedures in the Utensil and Small Equipment wash room and Mixing area.

i. Make improvements if warranted in any of these areas. c. Review environmental monitoring results for Listeria spp. to identify potential

issues, regardless of whether or not Listeria is found in the product. i. Direct cleaning and sanitation in areas of potential concern.

d. If Salmonella is detected in sampled product, in addition to observation of cook procedures and temperature verification (see 2a), initiate environmental monitoring for Salmonella, focusing on the Assemble/Wrap area and transition hallway between Assemble/Wrap and Cook areas to identify potential environmental sources. Continue weekly until results are negative for 5 consecutive weeks, then reduce to monthly.

e. Increase routine sampling for Enterobacteriaceae to at least weekly until 5 consecutive results are acceptable. Then return to the routine schedule.

3. Provide staff training a. Review the situation with staff to alert them to the issue. Seek input on potential

areas of improvement that can help resolve the issue. 4. In the event of a persistent issue, engage experts (e.g., testing lab or consultant P.H.

Books) for additional assistance.

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A3‐17

Process Preventive Control R

ecor

ds

Met

al D

etec

tor

Log

Man

ufac

ture

r’s

Val

idat

ion

Stu

dy th

at

dete

rmin

ed

dete

ctor

se

tting

s

and

sens

itivi

ty

stan

dard

s

Cor

rect

ive

actio

n re

cord

s

Verif

icat

ion

Pas

s X

mm

fe

rrou

s an

d Y

m

m n

on-

ferr

ous

and

stai

nles

s st

anda

rd

wan

ds th

roug

h de

tect

or a

t st

art-u

p,

mid

dle

and

end

of s

hift

to

assu

re

equi

pmen

t is

func

tioni

ng.

Rev

iew

of

Met

al D

etec

tor

Log

and

Cor

rect

ive

Act

ion

and

Ver

ifica

tion

with

in 7

w

orki

ng d

ays

Cor

rect

ive

Act

ion

If th

e pr

oduc

t is

pro

cess

ed

with

out m

etal

de

tect

ion,

ho

ld it

for

met

al

dete

ctio

n.

Cor

rect

op

erat

ing

proc

edur

es to

en

sure

that

th

e pr

oduc

t is

not p

roce

ssed

w

ithou

t met

al

dete

ctio

n

If m

etal

is

foun

d in

pr

oduc

t, se

greg

ate

prod

uct,

insp

ect b

ack

to th

e la

st

good

che

ck,

rew

ork

or

disc

ard

prod

uct

depe

ndin

g on

m

etal

type

an

d pr

eval

ence

. Id

entif

y so

urce

of t

he

met

al fo

und

and

fix

dam

aged

eq

uipm

ent i

f re

leva

nt

Mon

itorin

g

Who

P

rodu

ctio

n em

ploy

ee

Pro

duct

ion

empl

oyee

Freq

uenc

y B

egin

ning

, m

iddl

e an

d en

d of

shi

ft

Whe

n pr

oduc

t is

reje

cted

How

V

isua

l ex

amin

atio

n th

at th

e de

tect

or is

on

and

re

ject

de

vice

is

wor

king

Exa

min

e pr

oduc

t re

ject

ed b

y el

ectro

nic

met

al

dete

ctor

to

dete

rmin

e ca

use

of

kick

-out

Wha

t A

ll of

the

prod

uct

pass

es

thro

ugh

an

oper

atin

g m

etal

de

tect

or

Kic

k-ou

t pr

oduc

t fo

r the

pr

esen

ce

of m

etal

fra

gmen

ts

Crit

ical

Li

mits

M

etal

de

tect

or

pres

ent

and

oper

atin

g

No

met

al

fragm

ent

s th

at

wou

ld

caus

e in

jury

or

chok

ing

are

in th

e pr

oduc

t pa

ssin

g th

roug

h th

e m

etal

de

tect

or

Haz

ard

(s)

Met

al

incl

usio

n

Proc

ess

Con

trol

Met

al

dete

ctio

n

Public

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A3‐18

AllergenPreventiveControl

Ingredient Allergen Identification

Raw Material Name Supplier

Allergens in Ingredient Formulation

Alle

rgen

s in

Pr

ecau

tiona

ry

Labe

ling

Egg

Milk

Soy

Whe

at

Tree

Nut

(m

arke

t nam

e)

Pean

ut

Fish

(m

arke

t nam

e)

Shel

lfish

(m

arke

t nam

e)

Whole, liquid pasteurized egg

Your Egg Co. X

None

Grade A pasteurized milk

A Local Dairy X

None

Pan release oil, ABC Brand

My distributor X

None

Salt, XYZ Brand My distributor

None

Buttermilk biscuit Flaky Co. X X None

Pasteurized process cheese

Cheesy Co. X

None

How to Use the Chart List all ingredients received in the facility. Identify allergens contained in each ingredient by reviewing ingredient labels or contacting the manufacturer. Any allergens listed in “May contain” or other precautionary labeling on ingredients should be listed in the last column and reviewed to determine if allergen labeling is needed on the finished product.

NOTE: The above format is an alternative for an allergen specific hazard analysis. If you choose to use a form like this, then there is no need to duplicate allergen considerations in your hazard analysis chart. Duplication of information in multiple forms can create extra work and may lead to inconsistencies.

Some organizations may even choose to do an ingredient hazard analysis that considers not only allergens, but also other hazards. This may be a useful option for you.

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A3‐19

Rec

ords

Alle

rgen

La

bel

Ver

ifica

tion

listin

g;

Alle

rgen

La

bel

Ver

ifica

tion

log;

Cor

rect

ive

Act

ion

reco

rds;

Ver

ifica

tion

reco

rds

Alle

rgen

La

bel

Ver

ifica

tion

listin

g

Alle

rgen

La

bel

Che

ck L

og;

Cor

rect

ive

Act

ion

reco

rds;

Ver

ifica

tion

reco

rds

Verif

icat

ion

Rev

iew

of

Labe

l ve

rific

atio

n,

Cor

rect

ive

Act

ion

and

Ver

ifica

tion

reco

rds

with

in 7

w

orki

ng

days

Rev

iew

of

Labe

l C

heck

, C

orre

ctiv

e A

ctio

n an

d V

erifi

catio

n re

cord

s

with

in 7

w

orki

ng

days

Cor

rect

ive

Act

ion

If la

bel i

s in

corr

ect,

reje

ct

labe

ls a

nd

retu

rn to

su

pplie

r or

dest

roy.

Id

entif

y ro

ot c

ause

an

d co

nduc

t tra

inin

g as

ne

eded

to

prev

ent

recu

rren

ce

If la

bel i

s in

corr

ect,

segr

egat

e pr

oduc

t, in

spec

t ba

ck to

the

last

goo

d ch

eck,

re

labe

l pr

oduc

t; id

entif

y ro

ot c

ause

an

d co

nduc

t tra

inin

g as

ne

eded

to

prev

ent

recu

rren

ce

Mon

itorin

g

Who

Labe

l co

ordi

nato

r

Fill

line

oper

ator

Freq

uenc

y

Bef

ore

rele

ase

to

prod

uctio

n

Beg

inni

ng

and

end

of

run

and

whe

n la

bel

stoc

k is

ch

ange

d

How

Vis

ual

chec

k of

ca

rton

labe

l to

mat

ch

prod

uct

form

ula

Vis

ual

chec

k of

ca

rton

labe

l to

mat

ch

prod

uct

num

ber

Wha

t

Ingr

edie

nt

listin

g an

d al

lerg

en

decl

arat

ion

m

atch

es

prod

uct

Labe

l nu

mbe

r m

atch

es

prod

uct

Crit

erio

n

All

finis

hed

prod

uct

labe

ls m

ust

decl

are

the

alle

rgen

s pr

esen

t in

the

form

ula

per l

istin

g

All

finis

hed

prod

uct

mus

t hav

e co

rrec

t la

bele

d ca

rton

Haz

ard(

s)

Und

ecla

red

alle

rgen

s –

egg,

milk

, so

y (w

heat

in

bis

cuit

only

)

Und

ecla

red

alle

rgen

s –

egg,

milk

, so

y (w

heat

in

bis

cuit

only

)

Alle

rgen

C

ontr

ol

Rec

eivi

ng

pack

agin

g (la

bele

d ca

rton)

Fill,

w

eigh

, la

bel

Public

Ver

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A3‐20

Allergen Label Declaration

Allergen Verification Listing Product Allergen Statement Label Number Plain Omelet Contains: Egg, milk, and soy P 082015 Cheese Omelet Contains: Egg, milk, and soy C 082015 Cheese Omelet Biscuit Contains: Wheat, egg, milk and soy B 082015

Allergen Scheduling and Cleaning Implications Production Line Allergen Assessment

Product Name Production

Line

Intentional Allergens Eg

g

Milk

Soy

Whe

at

Tree

Nut

(m

arke

t nam

e)

Pean

ut

Fish

(m

arke

t nam

e)

Shel

lfish

(m

arke

t nam

e)

Plain Omelet 1 X X X

Cheese Omelet 1 X X X

Cheese Omelet Biscuit

1 X X X X Unique allergen

Scheduling Implications: Standard practice is to run the Plain and/or Cheese Omelet in the beginning of the shift and the Cheese Omelet Biscuit at the end of the shift to reduce the potential for allergen cross-contact. [Consider adding when alternate production practices may be permitted, including approval for this, if you wish.]

Allergen Cleaning Implications: (Required) A full allergen clean is required AFTER production of Cheese Omelet Biscuit because it contains a unique allergen – wheat.

How to Use This Form Complete for each production line. Identify each allergen contained in each product produced on the line. Identify any allergens unique to a specific product, then indicate scheduling information (i.e., run unique allergens last) and allergen cleaning information (i.e., full allergen clean before running cheese or plain omelets after a biscuit run.

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A3‐21

SanitationPreventiveControlObjective: To address 1) cleanliness of food contact surfaces and 2) prevention of allergen cross-contact and cross-contamination (recontamination)

Assemble/Wrap Table Sanitation Purpose: Cleaning and sanitizing of the assembly and wrapping table is important to

remove potential allergens and reduce microbial cross-contamination or recontamination with environmental pathogens that may impact product safety.

Frequency:

Cleaning: At lunch break, after Cheese Omelet Biscuit production, at the end of daily production.

Sanitizing: Before operations begin, at lunch break, after Cheese Omelet Biscuit production, and at the end of daily production.

Who: Sanitation team member

Procedure: Note: Blue cleaning tools are to be used ONLY for cleaning after a cheese biscuit run to

reduce the potential for unintentional allergen transfer.

Cleaning 1. Remove unused packaging material to an area at the end of the shift to prevent it

from getting wet. Cover it during the lunch clean up. 2. Remove gross soil with a squeegee. 3. Wipe table surface with a clean cloth dipped in ABC cleaning solution (Y oz. per

gallon). 4. Rinse table with clean water. Detergent remaining on the surface can inactivate the

sanitizer.

Sanitizing 1. Spray table surface with 200 ppm quaternary ammonium compounds solution,

ensuring that entire surface is covered. 2. Allow table to air dry, about 5 minutes. Contact time required per label – 1 minute.

Monitoring (at frequency indicated above): Inspect table for residual soil and cleanliness. Record on Daily Sanitation sheet. Use test strip to measure the quat concentration BEFORE application. Record on Daily

Sanitation sheet

Corrections: If residual soil is observed on the table, reclean and sanitize. If quat is not at the proper concentration, make a new solution.

Records: Daily Sanitation Sheet

Verification: Supervisor reviews and signs Daily Sanitation Sheet within 7 working days

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Assemble/Wrap Environmental Sanitation Purpose: Cleaning and sanitizing of the floor and the table support (legs) in the

Assemble, Wrap area is important to prevent establishment of environmental pathogens.

Frequency: Daily, after production

Who: Sanitation team member

Procedure: Cleaning and sanitizing the table support structure Cleaning is done in conjunction with cleaning of the table, following the same procedure, including table legs, and edges at the end of the day. Cleaning floors NOTE: Separate tools are used for floors because of the potential for higher levels of contamination.

1. Remove gross soil with a squeegee. 2. Mop floor using a washable mop head, using a clean mop each day 3. Rinse floor with clean water. Detergent remaining on the floor can inactivate

the sanitizer. Sanitizing

1. Spray floors with a 400-600 ppm quat sanitizer. Spray may also contact non-food contact table legs.

2. Allow floor to air dry overnight.

Monitoring (at each cleaning time): 1. Inspect floor and surrounding area for residual soil and cleanliness. Record on

Daily Sanitation sheet. 2. Use test strip to measure the quat concentration BEFORE application. Record on

Daily Sanitation sheet

Corrections: 1. If residual soil is observed, reclean and sanitize. 2. If quat is not at the proper concentration, make a new solution.

Records: Daily Sanitation Sheet, Daily Hygienic Zoning Record, Environmental Monitoring Sampling record and lab results

Verification: Environmental monitoring (frequency per procedure) and supervisor records review within 7 working days

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A3‐23

Assemble/Wrap Hygienic Zoning Purpose: Hygienic zoning in the assembly and wrapping table area is important to

minimize the potential of re-contamination with environmental pathogens.

Frequency: During production

Who: Employees and other individuals entering the Assemble, Wrap area

Procedure: Employees entering the Assemble Wrap area must (in the order listed): 1. Take a clean, blue smock from the rack outside the production area and put it on.

Smocks must cover outer clothing that would be above the assembly table surface.

2. Take the correct size clean rubber boots from the shelves along the wall outside the Assembly Wrap area and put them on over shoes.

3. Take a blue hairnet from the box by the entry and put it on. Ensure that all loose hair is captured. Men with facial hair should also apply beard nets.

4. Wash hands just before entering the Assembly Wrap area following the procedures posted by the sink. Apply a clean pair of gloves.

5. When exiting the room deposit smocks and boots in the receptacles provided. DO NOT return them to the clean smock and shoe cover receptacle.

Maintenance workers and visitors must use foot covers and clean smocks when entering this area. Traffic in this area is minimized during production.

Monitoring: The sanitation supervisor visually observes the presence of the properly smocked employees, before start up and after lunch break, and every 2 hours.

Corrections: Employee is instructed to gown properly.

Records: Daily Hygienic Zoning Record, Environmental Monitoring Sampling Record and lab results

Verification: Environmental monitoring and records review within 7 working days

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A3‐24

Environmental Monitoring for Sanitation Preventive Control Verification

Purpose: Environmental monitoring is conducted to verify the effectiveness of sanitation and hygienic zoning procedures in the Assemble, Wrap area to control environmental pathogens such as L. monocytogenes.

Sample identification: Based on observation when sampling, “worst case” areas are sampled; e.g., standing water or product residue, around table legs, crevasses major traffic areas. Record the specific location sampled.

Sampling procedure: Every other week, sponge swabs are collected during production, at least 3 hours after production starts. Sampling time is not uniform to avoid bias of results. Samples are shipped to the laboratory using the sampling kit provided by the laboratory. Samples are refrigerated and shipped in an insulated cooler with a gel pack with next day delivery. Samples are NOT frozen.

The following number of samples collected each time. x 4 in Assemble, Wrap area x 2 in Hall between Assemble, Wrap and Cooking x 1 at employee gowning area x 3 other samples based on observed conditions

Laboratory: Wee Beasties Laboratory (987 Critter Drive, Yourtown, USA) conducts the analysis using FDA BAM procedures. Analysis is started within 48 hours of sampling.

Test conducted: For routine samples, the contract lab composites sponges from the same area following XYZ1 recommended procedures to run as one test for Listeria species. Investigation samples must be run individually. The test result sheet identifies the specific method number used.

Interpretation of results: Acton for a negative result – Continue routine operations

Corrective action for a positive result:

1. If a composite is positive, the positive areas are re-sampled within a day of notification and prior to implementing intensive sanitation procedures. Additional samples (number depends on size of area) are taken in other potential problem areas in an attempt to identify a site of contamination. All samples are run individually, without compositing.

2. Intensive sanitation procedures are implemented after sampling is complete. 3. Production can continue after sanitation is complete and product can be shipped. 4. If all re-samples are negative, resume the normal sampling frequency. 5. If one or more re-samples are positive, perform corrective action investigation to resolve

the issue. Implement a hold and finished product testing procedure per the Product Testing for Verification corrective action protocol.

1 XYZ would be a scientifically valid method, such as AOAC, ISO, FDA etc.

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Supply chainPreventiveControlsProgram

Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control Ingredient (requiring supply-chain-applied control)

Approved Supplier

Hazard(s) requiring supply-chain-applied control

Date of Approval

Verification method

Verification records

Pasteurized process cheese

Cheesy Co., Cowtown, USA

Vegetative and sporeforming pathogens such as Salmonella, pathogenic E. coli, L. monocytogenes and C. botulinum

10/08/2010 Copy of 3rd party audit by a qualified auditor obtained from supplier

Audit report kept in Supplier Verification file

Receiving Procedure for Ingredients Requiring a Supply-chain-applied Control Purpose: Ensure that all ingredients requiring a supply-chain-applied preventive control are

received from approved suppliers with appropriate preventive controls in place.

Frequency: Each delivery

Who: Receiving clerk

Procedure: 1. Verify that each load of Pasteurized Process Cheese was produced by Cheesy Co.

located in Cowtown, USA by checking the bill of lading and manufacturer name on the cases received.

2. Document on receiving sheet

Corrections: If product is not from the approved supplier:

1. Receiving clerk places product on hold, notifies QA 2. QA reviews status and

x Rejects load, or x Attaches to the receiving record documentation of verification activity applied

for use of cheese from temporary supplier, allowing release for use x Marks the receiving record and sample “Food for research or evaluation use”

and attaches a sticker stating “Food for research or evaluation use” and retains the shipping document (Bill of Lading) stating that the food is for research or evaluation purposes and cannot be sold or distributed to the public.

Records: Receiving Sheet, Food for Research or Evaluation Use sticker, Bill of Lading

Verification: Receiving records review within 7 working days

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Determination of Verification Procedures Ingredient: Pasteurized Process Cheese

Hazards requiring a supply-chain-applied control: Hazard analysis determined that vegetative pathogens, such as Salmonella, pathogenic E. coli, and L. monocytogenes and the sporeforming pathogen C. botulinum are hazards requiring supply-chain-applied controls in the production of pasteurized process cheese. We do not have a kill step for cheese.

Preventive controls applied by the supplier: The pasteurization process must kill the vegetative pathogens when the cheese is made. Cheese formulation must prevent growth of C. botulinum.

Conclusion: A 3rd party supplier audit by a qualified auditor is used to verify control of the identified hazards by the approved supplier Cheesy Company, located in Cowtown, USA.

Verification procedures: A copy of a 3rd party audit of their Cowtown location is requested from Cheesy Company on an annual basis and kept on file. The audit date, auditor qualifications, audit procedures and audit results are reviewed. If any requirements are deficient (including auditor qualifications) and follow up discussion with the Cheesy Company’s Quality Manager in Cowtown takes place, as necessary, to determine what, if any, verification activities are needed for any deficiencies requiring corrective actions mentioned in the report.

Records: Copy of the audit report and, where necessary, verification of corrective actions taken by the supplier are maintained on file by the Food Safety Team Leader.

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A3‐27

RecallPlanThe Recall Plan is maintained by F.S. Leader, with a copy in the Plant Manager’s Office.

ImplementationRecordsImplementation records and forms used for Preventive Controls include the following:

x Monitoring records for preventive controls o Cook Log o Metal Detection Log o Allergen Label Check Log o Allergen Run Order Log o Daily Sanitation Log

x Corrective actions records x Verification records x Supply-chain program records x Training records for the qualified individuals (in personnel files) x Food Safety Plan Reanalysis Report

Applicable records and examples of forms follow.

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A3‐28

Monitoring Records Forms

Cook Log

Hazard: Vegetative pathogens such as Salmonella Parameters, values or critical limits: Omelet surface temperature is ≥158°F (70°C) instantaneous before transfer to assembly table. Who, How, Frequency: QA Technician, or designee, checks an omelet surface temperature each cook station 4 times/shift (every 2-3 hr) using an infrared thermometer. Corrective Action: Hold product back to the last good check and evaluate - rework, discard, or release. Determine root cause – retrain or correct as appropriate. Date:

Time Cook Station

Cook name Temperature (°F)

QA Tech (initials)

Verification Reviewer Signature: Date of Review:

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A3‐29

Metal Detection Log

Hazard: Metal inclusion Parameters, values or critical limits:

1) All of the product passes through an operating metal detector and 2) No metal fragments that would cause injury or choking are in the product passing through the

metal detector Procedure: Pass X2 mm ferrous and Y mm non-ferrous and stainless standard wands through detector at start-up, middle, end of shift and when any product change occurs to assure equipment is functioning. Corrective action:

1) If the product is processed without metal detection, hold it for metal detection. Correct operating procedures to ensure that the product is not processed without metal detection

2) If metal is found in product, segregate product, inspect back to the last good check, rework or discard product depending on metal type and prevalence. Identify source of the metal found and fix damaged equipment if relevant

Date: ____________________

Time Product Lot Number Detector present and on (Yes/No)

Detector rejects ferrous, non-ferrous, and stainless standards (Yes/No)

Line Operator (Initials)


2 X and Y values are determined during equipment calibration.

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A3‐30

Allergen Label Check Log Hazard: Undeclared allergens Parameters: All finished product labels must declare the allergens present in the formula as follows:

Plain Omelet: Egg, milk, soy Cheese Omelet: Egg, milk, soy Cheese Biscuit Omelet: Wheat, egg, milk, soy

Corrective Action: If label is incorrect, segregate product, inspect back to the last good check, relabel product; identify root cause and conduct training as needed to prevent recurrence

Date Time Product Lot Number Proper Label Applied (Yes/No)



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Allergen Run Order Record Hazard: Allergen cross-contact from other products handled at this step; e.g., Cheese Omelet Biscuit.

Parameter: Routinely, run the Plain and/or Cheese Omelet in the beginning of the shift and the Cheese Omelet Biscuit at the end of the shift to reduce the potential for allergen cross-contact. If necessary, Cheese Omelet Biscuit can be run before the Plain or Cheese Omelet IF a full allergen clean is performed AFTER production of Cheese Omelet Biscuit because it contains a unique allergen – wheat.

Corrective Action: If full allergen clean was not performed after running Omelet Biscuit, segregate product, hold all product produced after the Omelet Biscuit up to the next full allergen clean; evaluate product and determine appropriate disposition; identify root cause and conduct training as needed to prevent recurrence

Product Name Date Start Time

End Time

Allergen Clean After

Run (Yes/No)

Initials for

allergen clean

Verification Signature Date:

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A3‐32

Daily Sanitation Control Record – Omelet Line

Date: _______________________

Sanitation Area and Goal

Pre-Op

Time: Start Time:

Lunch Break Time:

Post-Op

Time: Comments and

Corrections Operator Initials

Condition & Cleanliness of Food Contact Surfaces x Equipment cleaned and sanitized (S/U)* x Sanitizer type and strength: Quaternary

ammonium compound, 200 ppm Omelet line (ppm)+

Dish room dip tank (ppm)+ Prevention of Allergen Cross-Contact x Cleaning after Cheese Omelet Biscuit (S/U/NA)

Condition & Cleanliness of Non-food Contact Surfaces x Floors and wall splash zones cleaned and

sanitized (S/U)

x Sanitizer Strength: Sanitizer Type: Quaternary ammonium compound Strength: 400-600 ppm

Floors and wall splash zones (ppm)+

* S = Satisfactory, U = Unsatisfactory + Enter ppm measured per test strip & NA = not applicable because Cheese Omelet Biscuit run after other products Verification signature:

Date:

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A3‐33

Corrective Action Records Corrective action records are maintained by the Food Safety Team Leader. An example of the Corrective Action Form follows.

Corrective Action Form

Date of Record: Code or Lot Number:

Date and Time of Deviation:

Description of Deviation:

Actions Taken to Restore Order to the Process:

Person (name and signature) of Person Taking Action:

Amount of Product Involved in Deviation:

Evaluation of Product Involved with Deviation:

Final Disposition of Product:

Reviewed by (Name and Signature): Date of Review:

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A3‐34

Verification Records Verification records are maintained by the Food Safety Team Leader. Examples of verification forms are included as indicated below:

Verification Record Location Omelet cook step validation study Study included in process control section of

this plan

Verification of monitoring and corrective action

Documented on the relevant forms, examples of which are in the previous sections

Calibration of monitoring and verification instruments

x Daily Thermometer Accuracy Check

x Annual Thermometer Calibration Log

Example forms follow

Product Testing Procedure included with Cook process control record. Results forms provided by testing lab

Environmental Monitoring Procedure included with Sanitation Preventive Controls. Results forms provided by testing lab

Annual Food Safety Plan Reanalysis Report Form

Example form follows

Supply-chain Program Procedures includes with Supply-chain Preventive Controls in the Food Safety Plan. Receiving Log maintained in receiving files.

Bill of Lading maintained for research product received.

Audit results are maintained in by the Food Safety Team Leader

Training Maintained in personnel files

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A3‐35

Daily Thermometer Accuracy Check

Verification: Check each thermometer daily for accuracy. Temperature must be r2°F (1°C) from standard.

Date of Calibration

Instrument Number

Boiling Water Temp (212r2°F)*

Ice Bath Temp (32r2°F)

Temperature within Specification (Yes/No)



* Temperature adjustments may be needed for different altitudes

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A3‐36

Annual Thermometer Calibration Log

Verification: Send each thermometer to Accurate Instrument Checker Lab for calibration twice a year. Temperature must be r2°F (1°C) from standard. Keep records of results on file.

Date of Calibration

Instrument Number

Method of Calibration

Calibration Results

Temperature within Specification (Yes/No)



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A3‐37

Receiving Log

Verification: Pasteurized process cheese must be received from Cheesy Co., Cowtown, USA

This teaching example is not realistic for many companies because there is only one ingredient requiring a supply-chain-applied control. Most companies have receiving procedures and many require approved suppliers for both quality and safety considerations. Your standard receiving records may be suitable as the record verifying that raw materials and other ingredients requiring a supply-chain-applied control come from an approved supplier if it is set up to do so. A check list, a bar code scan, a computer spread sheet and other methods could be used to verify receipt from approved supplier locations. Use a format that works for your organization, keeping in mind that the record must be created when the activity occurs and that the activity must be verified by or under the supervision of a preventive controls qualified individual.

Supplier Audit Verification

Purpose: Review of 3rd party audit for suppliers of supply-chain-applied control

Supplier Name, location

Date of Review

Date audit conducted

Audit procedures in the report (yes/no and comments)

Audit performed by (e.g., certification body name)

General audit conclusion

Required corrective action(s) noted

Supplier response to corrective action

Trends noted from previous reports

Conclusions of the review

Reviewed by:

Date:

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A3‐38

Food Safety Plan Reanalysis Report

(Add rows as needed if different plans are used for different products)

Checklist Date reviewed and initials of reviewer

Update needed Yes/No

Date Updated Completed:

Person Completing the Update (initial or sign)

List of Food Safety Team

List of products and processes in place at facility

Product flow diagrams

Hazard Analysis




Supply-chain Preventive Control Program

Recall Plan

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A4‐1

Appendix 4: Foodborne Pathogen Supplementary Information Microbialgrowthcanbelimitedwhenconditionsareoutsideofanorganism’sgrowthparameters,andcertaintime‐temperaturecombinationscaninactivatefoodbornepathogensinfoods.Thisappendixpresentsseveraltableswithinformationonparametersthatcanbeusedtoinhibitgrowthorinactivatecertainmicroorganisms.

x TableA4‐1summarizesconditionsthatlimitorpreventfoodbornepathogengrowthortoxinformation,includingtemperature,pH,wateractivityandmaximumpercentofwaterphasesalt.

x TableA4‐2providesinformationontime‐temperaturecombinationsthat,underordinarycircumstances,willpreventgrowthoffoodbornebacterialpathogens.Thisincludesinformationonmaximumcumulativetimeandinternaltemperaturecombinationsforexposureoffoodsthat,underordinarycircumstances,willbesafeforthebacterialpathogensthatareofgreatestconcern.Theexposuretimesarederivedfrompublishedscientificinformation.Becausebacterialgrowthislogarithmic,linearinterpolationusingthetimeandtemperatureguidancemaynotbeappropriate.Furthermore,thefoodmatrixeffectsbacterialgrowth(e.g.,presenceofcompetingmicroorganisms,availablenutrients,growthrestrictiveagents).ConsiderationofsuchattributesisneededwhenusingtheinformationinTablesA4‐2.

x TableA4‐3providesinformationontime‐temperaturecombinationsfordestructionofL.monocytogenes.Lethalrate,asusedinthistable,istherelativelethalityof1minuteatthereferenceinternalproducttemperatureof158 F(70 C)(i.e.,z 13.5 F(7.5 C)).Forexample,1minuteat145 F(63 C)is0.117timesaslethalas1minuteat158 F(70 C).Thetimesprovidedarethelengthoftimeatthedesignatedinternalproducttemperaturenecessarytodeliverasixlogarithm(6D)processforL.monocytogenes.ThelengthoftimeataparticularinternalproducttemperatureneededtoaccomplishasixlogarithmreductioninthenumberofL.monocytogenes(6D)is,inpart,dependentuponthefoodinwhichitisbeingheated.Thevaluesinthetablearegenerallyconservativeandapplytoallfoods. oumaybeabletoestablishashorterprocesstimeforyourfoodbyconductingscientificthermaldeathtimestudies.Additionally,lowerdegreesofdestructionmaybeacceptableinyourfoodifsupportedbyascientificstudyofthenormalinitiallevelsinthefood.Itisalsopossiblethathigherlevelsofdestructionmaybenecessaryinsomefoods,ifespeciallyhighinitiallevelsareanticipated.

x TableA4‐4listspropertiesofcommonbacterialfoodbornepathogens.Informationsuchaspathogenicity,primarysources,typesoffoodsinvolvedintransmission,contributingfactors,atmosphererequiredforgrowth,whethertheorganismisasporeformer,andotherpropertiesareincluded.

Thetablesarefollowedbyanalphabeticallistingoftheorganisms(bacteria,virusesandparasites)identifiedbyPainteretal.(2013)asbeingrelevantfortransmissionthroughfood.MoreinformationonfoodbornepathogensisavailableinFDA’sBadBugBook(seereferences).

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Appendix 4

A4‐2

TableA4 1Limitingconditionsforpathogengrowth

OrganismTemperature F( C) pH WaterActivity(aW)

Max. waterphasesaltMinimum Optimum Maximum Minimum Optimum Maximum Minimum Optimum Maximum

Bacilluscereus 3 (4) 86‐104(30‐40)

131(55) 4.3 6.0‐7.0 .3 0. 2 ‐ ‐ 10

Campylobacter 86(32) 108‐10 (42‐43)

113(45) 4. 6.5‐7.5 .5 0. 87 0. 7 ‐ 1.7

Clostridiumbotulinumx ProteolyticABF

50(10) 5‐104(35‐40)

‐118(48) 4.6 ‐ 0. 35 ‐ ‐ 10

x Non‐proteolyticBEF 38(3.3) 82‐86(28‐30)

113(45) 5.0 ‐ 0. 70 ‐ ‐ 5

Clostridiumperfringens 50(10) 10 ‐117(43‐47)

126(50) 5 7.2 .0 0. 3 0. 5‐0. 6 0. 7

EnterohemorrhagicEscherichiacoli(EHEC)

44(6.5) 5‐104(35‐40)

121(4 .4) 4 6‐7 10 0. 5 0. 5 ‐ 6.5

L.monocytogenes 31(‐0.4)

(37) 113(45) 4.4 7.0 .4 0. 2 ‐ ‐ 10

Salmonella 41(5.2) 5‐10 (35‐43)

115(46.2) 3.7 7‐7.5 .5 0. 4 0. 0. 8

Shigella 43(6.1) ‐ 117(47.1) 4.8 ‐ .3 0. 6 ‐ ‐ 5.2Staph.aureusx growth(anaerobic)

45(7)

(37)

122(50)

4

6‐7

10

0.83(0. 0)

0. 8

0.

20

x toxin(anaerobic) 50(10) 104‐113(40‐45)

118(48) 4 7‐8 .8 0.85 0. 8 0. 10

StreptococcusgroupA 50(10) (37) 113( 45) 4.8‐5.3 7 .3 ‐ ‐ ‐ 6.5Vibriospp. 41(5) (37) 114(45.3) 4.8 7.6‐8.6 11 0. 4 0. 1‐0. 0. 8 10Yersiniaenterocolitica 30

(‐1.3)77‐ (25‐37)

108(42) 4.2 7.2 10 0. 45 ‐ ‐ 7

FromFDA2011.FishandFisheryProductsHazardsandControlsGuidance.4thEditionandInternationalCommissiononMicrobiologicalSpecificationsforFoods.1 6.MicroorganismsinFoods5:MicrobiologicalSpecificationsofFoodPathogens.BlackieAcademicandProfessional,New ork.

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Foodborne Pathogen Supplementary Information

A4‐3

TableA4 2.Cumulativetimeandtemperatureguidanceforcontrollingpathogengrowthandtoxinformationinfoods1

PotentiallyHazardousCondition ProductTemperature

MaximumCumulativeExposureTime

Bacilluscereusgrowthandtoxinformation 3 .2‐43 F(4‐6 C)44‐5 F(7‐15 C)60‐70 F(16‐21 C)Above70 F(21 C)

5days1day6hours3hours

Campylobacterjejunigrowth 86‐ 3 F(30‐34 C)Above 3 F(34 C)

48hours12hours

Clostridiumbotulinumgermination,growthandtoxinformationTypeAandproteolyticTypesBandF

50‐70 F(10‐21 C)Above70 F(21 C)

11hours2hours

‐TypeEandnon‐proteolyticTypesBandF

37. ‐41 F(3.3‐5 C)42‐50 F(6‐10 C)51‐70 F(11‐21 C)Above70 F(21 C)

7days2days11hours6hours

Clostridiumperfringensgrowth 50‐54 F(10‐12 C)55‐57 F(13‐14 C)58‐70 F(15‐21 C)Above70 F(21 C)

21days1day

6hours22hours

Escherichiacolipathogenicstrainsgrowth 43.7‐50 F(6.6‐10 C)51‐70 F(11‐21 C)Above70 F(21 C)

2days5hours2hours

Listeriamonocytogenesgrowth 31.3‐41 F(‐0.4‐5 C)42‐50 F(6‐10 C)51‐70 F(11‐21 C)71‐86 F(22‐30 C)Above86 F(30 C)

7days1days7hours3hours1hour

Salmonellaspeciesgrowth 41.4‐50 F(5.2‐10 C)51‐70 F(11‐21 C)Above70 F(21 C)

2days5hours2hours

Shigellaspeciesgrowth 43‐50 F(6.1‐10 C)51‐70 F(11‐21 C)Above70 F(21 C)

2days5hours2hours

Staphylococcusaureusgrowthandtoxinformation 50 F(10 C)51‐70 F(11‐21 C)Above70 F(21 C)

14days12hours23hours

Vibriospeciesgrowth 50 F(10 C)51‐70 F(11‐21 C)71‐80 F(22‐27 C)Above80 F(27 C)

21days6hours2hours1hour3

Yersineaenterocoliticagrowth 2 .7‐50 F(‐1.3‐10 C)51‐70 F(11‐21 C)Above70 F(27 C)

1days6hours2.5hours

1AdaptedfromFDA2011.FishandFisheryProductsHazardsandControlsGuidance.4thEditionandassumeshighwateractivityfoodwithpHnearneutrality

2Additionaldataneeded3Appliestocooked,ready‐to‐eatfoodsonly

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Appendix 4

A4‐4

TableA4 3InactivationofListeriamonocytogenes

InternalProductTemperature( F)

InternalProductTemperature( C)

LethalRate Timefor6DProcess(Minutes)

145 63 0.117 17.0147 64 0.158 12.714 65 0.215 .3151 66 0.2 3 6.8153 67 0.3 8 5.0154 68 0.541 3.7156 6 0.736 2.7158 70 1.000 2.0160 71 1.35 1.5162 72 1.848 1.0163 73 2.512 0.8165 74 3.415 0.6167 75 4.642 0.416 76 6.310 0.3171 77 8.577 0.2172 78 11.65 0.2174 7 15.84 0.1176 80 21.544 0.0 178 81 2 .286 0.07180 82 3 .810 0.05182 83 54.116 0.03183 84 73.564 0.03185 85 100.000 0.02

Note:z 13.5 F(7.5 C)FromFDA2011.FishandFisheryProductsHazardsandControlsGuidance.4thEditionandassumeshighwateractivityfoodwithpHnearneutrality

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A4‐5

TableA4

4.Propertiesofcom

monfoodbornebacterialpathogens

Other

Extensivegrow

th

requiredfor

illness.Emetic

toxinisheat

stable

Survivesbut

proliferates

poorlyoutsideof

theanimalhost

‐

Mesophilicand

psychotropic

strains

‐ ‐ ‐

Spore/

nonspore

Sporeformer

Non‐

sporeformer

Non‐

sporeformer

Sporeformer

Sporeformer

Non‐

sporeformer

Non‐

sporeformer

Atmosphere

Facultative–

grow

swithor

without

oxygen

Aerobic

3‐5

oxygen

optim

um

Anaerobic–

requires

absenceof

oxygen

Anaerobic

Facultative‐

grow

swithor

without

oxygen

Facultative

Contributing

Factors

Temperature

abuse

Consum

ptionof

infected

unpasteurized

milkproducts

Cross

contam

inationand

undercooking

Temperature

abuse

Inadequatehot

holdingand

reheating

PoorGAP,

inadequate

heating,and

person‐to‐person

Environm

ental

pathogenspread

byenvironmental

contam

ination,

equipm

ent,people,

incomingraw

ingredients

Transm

ittedby

Rice,starchy

foods,meats,

vegetables,m

ilk

products,sauces

Uncooked/

unpasteurized

milkandmeat

Rawpoultry,raw

milkproducts,

contam

inated

water

Foodwith

anaerobic

environm

ent

Meats,stewsor

gravy,especially

thosecontaining

spices

Rawand

undercooked

beef,leafygreens,

sprouts,and

unpasteurized

milkandjuices

RefrigeratedRTE

foodsthat

supportgrowth

PrimarySources

Soil

Unpasteurized

milkand

undercooked

meat

Rawpoultry,raw

milkproducts,

contam

inated

water

Widespread

Soilandintestinal

tractofhealthy

peopleand

animals

Intestinaltractof

ruminantanimals

(e.g.,cow

s,sheep)

Occurswidelyin

agriculture(soil,

plantsandwater)

Pathogenicity

Producestw

otoxins

–diarrhealand

emetic(vom

iting)

Infectioncauses

fever,sweating,

weakness,muscle

aches,headache

Infectioncauses

diarrheaand

potentialnerve

damage

Toxininfoodcauses

blurredordouble

vision,paralysisof

respiratorymuscles,

death

Toxincauses

diarrheaand

abdominalpain

Infectioncauses

bloodydiarrheaand

sometimeskidney

failureanddeath

Infectioncauses

severeillnessin

susceptiblepeople–

mortality15‐30

Organism

Bacilluscereus

Brucellaspp.

Campylobacter

spp.

Clostridium

botulinum

Clostridium

perfringens

Shiga‐toxin

Producing

Escherichiacoli

(STEC)

Listeria

monocytogenes

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TableA4

4.Propertiesofcom

monfoodbornebacterialpathogens(continued)

Other

‐ ‐ ‐

Poor

competitor

‐

Requires

saltto

reproduce

‐

Spore/

nonspore

Non‐

sporeformer

Non‐

sporeformer

Non‐

sporeformer

Non‐

sporeformer

Non‐

sporeformer

Non‐

sporeformer

Non‐

sporeformer

Atmosphere

Grow

svery

slow

lyand

under

reduced

oxygen

Facultative

Facultative

Facultative

Facultative

Facultative

Facultative

Contributing

Factors

Lackofm

ilk

pasteurizationand

exposuretoaerosols

from

infected

animals

Cross‐contam

ination,

undercookedfood,

pooragricultural

practices,

environm

ental

contam

ination

‐

Recontam

inationand

temperatureabuse

‐ ‐ ‐

Transm

ittedby

Rawmilk

products

Meat,poultry,

eggs,raw

milk

andmanyother

foods(nuts,

spices,produce,

chocolate,flour)

Fecal

contam

ination

from

contam

inated

waterorinfected

foodworkers

Recontam

inated

cookedfoods,

andfoodsw

ith

highsaltorhigh

sugar

Infectedworkers

handlingfood

andconsum

ption

ofrawmilkor

meatproducts

Marineseafood

products

Cross

contam

ination

betweenraw

porkproducts

andRTEfoods

Primary

Sources

Cattleand

rawmilk

Intestinal

tractof

peopleand

animals

Hum

an

intestinal

tract

Boils,nasal

passagesand

skin

Infectedsites

ofhum

ans

andanimals,

rawmilk

Saltwater

environm

ent

andseafood

Rawpork,

rawmilk

Pathogenicity

Infectioncauses

respiratorysymptom

sandtuberculosis

Infectioncauses

nausea,vom

iting,

diarrhea,fever,

headache

Infectioncauses

diarrhea,whichmay

bewaterytobloody.

Theinfectioniscalled

dysentery

Producesheatstable

toxinsafterextensive

grow

th

Infectioncausessore

throat,tonsillitisand

fever

Infectionsymptom

svarydependingon

strain,rangingfrom

diarrheatohighfever

Infectioncauses

abdominalpain,fever

anddiarrhea.May

mimicappendicitis.

Organism

Mycobacterium

bovis

Salmonellaspp.

Shigellaspp.

Staphylococcus

aureus

Streptococcus

spp.groupA

Vibriospp.

Yersinia

enterocolitica

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Descriptions of Common Foodborne Pathogens Bacilluscereuscauseseithervomitingwithshortonset(30minutesto6hours),ordiarrheaandcrampsin6‐15hours.Differentstrainsproducetwodifferenttoxins–theoneresponsibleforshort‐onsetvomitingisheatresistant.Thetoxinthatcausesdiarrheaisproducedintheintestines.SymptomsmimicthoseofeitherS.aureus(vomitingtype)orC.perfringens(diarrhealtype).Manyfoodsareassociatedwiththediarrhealtypeofillness,whilericeandothergrainsandstarchyfoodsareassociatedwiththevomitingtype.Transmissionofillnessiscausedbyconsumptionoffoodcontainingpreformedtoxinforthevomitingtypeofillness,orhighlevelsofvegetativecellsproducedduringgrowthundertemperatureabuseforthediarrhealdisease.B.cereussporesareresistanttonormalcookingprocessesandthevegetativecellsgrowwithorwithoutoxygen(“facultative”).RefrigerationandfreezinginhibitB.cereusgrowthbutdonotkillthebacteria.

Brucellaspp.rarelycauseillnessintheUnitedStatesbecauseofpasteurizedmilk.Itmaybeanissuewithrawmilkproductsifstringentcontrolsarenotinplace.

Campylobactercausesdiarrhea2‐7daysaftereatingcontaminatedfoodandmaycausenervedamage1‐6weeksafterinfection.Thelivebacteriainvadethecellsliningtheintestine.Theprimarysourceisfecalcontaminationofrawpoultryandmeatandtransmissionisassociatedwithcrosscontaminationfromrawmeatorpoultrydrippingsorconsumptionofundercookedanimalproducts.Campylobacterissensitivetoheatanddrying,growsinreducedoxygenenvironments,growsbestabovebodytemperature,andsurvivesbutdoesnotgrowduringrefrigerationandfreezing.

Clostridiumbotulinumproducesseveraltypesoftoxins.TypesA,B,EandFtoxinsareconcernsinfoodandcausetheseverediseasecalledbotulism.Blurredordoublevision,drymouth,difficultyswallowing,paralysisofrespiratorymuscles,vomitinganddiarrheamaybepresent.Symptomsdevelop18‐36hours(sometimesdays)aftereatingcontaminatedfoodanddeathcanoccurunlesstreatmentisreceived.Recoverymaybeslow(months,rarelyyears).C.botulinumsporesmaybepresentinsoilandtheintestinaltractofanimalsandarewidespreadinnature.Thesporesareheatresistantand,undertherightconditionsintheabsenceofoxygen,cancomeoutofdormancyandproducetoxin.

SomeC.botulinumstrains(typeEandsomestrainsofBandF)cangrowatrefrigerationtemperatures,butmostcannot.Thesporesofstrainsthatgrowunderrefrigerationarenotasheatresistantasotherspores.Thetoxinisdestroyedbyhighheat(boilingfor5min);however,thediseaseissoseverethatheatingtodestroytoxinisnotanappropriatecontrolmethod.C.botulinumcangrowinmanyfoodsunderstrictanaerobic(lowoxygen)conditions.ApH 4.6preventstoxinproductionbyC.botulinum,andtoxinproductionforthosestrainsthatgrowunderrefrigerationisinhibitedatpH 5.0.Sodiumnitriteusedincuredfoodsslowstoxinproduction.

Clostridiumperfringenscausesdiarrheaandabdominalpain6‐24(typically8‐12)hoursaftereatingfoodcontaminatedwithlargenumbersofvegetativecells( 106/g),whichrequiresgrowthinthefood.Whentheseviablecellsareconsumed,theyformsporesandreleasetoxinintheintestines.C.perfringensisfoundinsoilandtheintestinaltractofhealthypeopleandanimals.Sporessurvivenormalcookingprocesses,includingboiling.SpicesareapotentialsourceforC.perfringensasthesporescanpersistonspicesforlongperiodsoftime.Inadequatehotholdingorcoolingofcookedfood,particularlymeats,potpies,steworgravies,allowsbacteriatomultiplybecausethesporescansurvivethecookingprocess.C.perfringenshasoneofthemostrapidgrowthratesforfoodbornepathogens,andcandoubleinlessthan10minutesatoptimumtemperature.Thispathogengrowsbestwithoutoxygen.

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Cryptosporidiumparvumisararelyreportedparasitebutisnotableforitsresistancetochemicalagents,includingstandardlevelsofchlorine.Itissensitivetodryingandultravioletlight.Cryptosporidiumcausesdiarrhea,andinfectioncanbefatalforimmunocompromisedpeople.Foodborneoutbreakshaveinvolvedappleciderandunpasteurizedmilk,aswellascontaminatedwater.

Cyclosporacayetanensisisararelyreportedparasitethatcausesprolongeddiarrhea.Deathrarelyoccurs.Outbreaksarefrequentlyassociatedwithfruits(berries),leafygreenandothersalads,andherbslikebasil.

EscherichiacoliisabacteriumthatisnormallypresentintheintestinaltractofhumansandotheranimalsandmoststrainsofE.coliarenotassociatedwithdisease.However,certainstrains,likeE.coliO157:H7,produceatoxincalledShiga‐toxininhumanintestines,causingseveredisease.Thesedisease‐causingstrainsarecalledenterohemorrhagic,Shiga‐toxinproducingE.coliorSTECs.Theycausediarrhea,whichmaybebloody,andoccasionallyfever,generally2‐3daysafteringestionoffood(range1‐5days).Kidneyfailureanddeath,especiallyinchildren,mayresult.VerylownumbersofsomeSTECscancauseillness.TheprimarysourceofSTECsisfecalcontaminationfromruminants,includingsheepanddeer.Theseanimalstypicallyshownosignofillness.Consumptionofraworundercookedhamburger,contaminatedproduce,sprouts,andunpasteurizedmilkandjuiceshavebeenlinkedtoillness.E.coliO157:H7andotherSTECsarekilledbymildheattreatments.Theycangrowwithorwithoutoxygen.Theoptimumtemperatureforgrowthisaroundhumanbodytemperature,andtheorganismgrowsinsomemoistfoodswithapHaslowas4.4.

STECs,orShiga‐toxinproducingE.coli,asagroupincludessomestainsthatcauseillnessandsomethatdonot.ThosethatcauseillnessaresometimescalledenterohemorrhagicE.coli,orEHEC.TheO157:H7straincurrentlypredominatesintheUS,causing 75 oftheEHECinfectionsworldwide.Othernon‐O157EHECserotypesalsocauseoffoodborneillnesses.IntheUnitedStatesO111,O26,O121,O103,O145,andO45arethemostcommonnon‐O157:H7serotypesisolatedfromclinicalinfections.However,otherEHECserotypes,suchasO113,O 1,andothers,alsocancausesevereillness.Thus,publichealthconcernsrelatedtoEHECcanchangerapidly.

Giardiaintestinalis(orlamblia),likeotherparasites,causesdiarrheaandisthemostcommonparasiticcauseofdiarrheaintheU.S.Contaminatedwateristheprimarysourceforoutbreaks,butfoodandpeoplespreadthedisease,andonlyonecystmaybeenoughtocauseillness.Illnessoccursabout2weeksaftereatingcontaminatedfood,sotracingthesourceofillnesscanbeverydifficult.Foodborneoutbreakswithidentifiedvehiclesincludeice,lettuce‐basedsalads,chickensaladandunspecifiedvegetables.

HepatitisAvirusiscausestheseverediseasehepatitis.ThehealthdepartmentwillbenotifiedifafoodworkercontractshepatitisA.SymptomsofhepatitisAincludeweakness,feverandabdominalpain.Astheillnessprogresses,theindividualusuallybecomesjaundiced(skinturnsyellow).Theseverityoftheillnessrangesfromverymild(youngchildrenoftenexperiencenosymptoms)tosevere,requiringhospitalization.Thefatalityrateislowanddeathsprimarilyoccuramongtheelderlyandindividualswithunderlyingdiseases.Illnessoccursabout2weeksaftereatingcontaminatedfood(butcanbemuchlonger),sotracingthesourceofillnesscanbeverydifficult.HepatitisAtransmissioncanbepreventedbypracticinggoodpersonalhygieneandexclusionofillworkers,vaccinationoffoodhandlers,thoroughcookingoffoodandpreventingcross‐contamination.HepatitisAappearstobemoreheatresistantthanotherviruses.AlaboratorystudyshowedthathepatitisAvirusesininfectedoysterswereinactivatedafterheatingat140 F(60 C)for1 minutes.

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Listeriamonocytogenescancausemeningitis,asevereinfectionwithsymptomsincludingsuddenfever,intenseheadache,nausea,vomiting,deliriumandcomainpeoplewithsuppressedimmunesystems.Uptoonethirdofthosewhoarehospitalizeddie.Inahealthyperson,infectionwithL.monocytogenesmaycausenosymptomsoraflu‐likeillnessanddiarrhea.Thisorganismisaparticularproblemforpregnantwomen(causingmiscarriage)andtheelderly.Illnessoccursabout2weeksaftereatingcontaminatedfood(butcanbemuchlonger)sotracingthesourceofillnesscanbeverydifficult.Refrigeratedready‐to‐eatfoodsareassociatedwithlisteriosisandfivekeyfactorsinfluenceriskofcontractinglisteriosisfromsuchfoods:1)theamountandfrequencyofconsumptionofthefood,2)thefrequencyandextentofcontamination,3)theabilityofthefoodtosupportL.monocytogenesgrowth,4)thetemperatureofrefrigeratedstorageand5)thedurationofrefrigeratedstorage.Ready‐to‐eatmeatproducts,unpasteurizeddairyproductsandotherlow‐acidready‐to‐eatfoodshavebeenassociatedwithlisteriosisoutbreaks.L.monocytogenesisanenvironmentalpathogen,thuspost‐heat‐processingcontaminationfromtheplantenvironment,includingplantpersonnel,equipment,floors,walls,drainsandcondensationfromcoolersisaprimarysourceofcontamination.Thisnon‐sporeformingbacteriumiskilledbypasteurizationtemperatures,growswithorwithoutair,andcangrowatrefrigerationtemperaturesandinhighersaltconcentrationsthansomeotherpathogens.Acidconditionsslowgrowthbutmayallowsurvival.L.monocytogenesisextremelyhardycomparedtomostbacteria,withstandsrepeatedfreezingandthawing,andsurvivesforprolongedperiodsindryconditions.

MycobacteriumbovisisanotherfoodbornebacterialpathogenthatrarelycausesfoodborneillnessintheU.S.becauseofimplementationofmilkpasteurizationrequirementsandremovalofinfectedcattle.Theprimarysourceiscattleandrawmilk.Thehazardcanbeeasilyavoidedbyusingpasteurizedmilk.Consumptionofraworundercookedmeat,suchasvenison,ofinfectedanimalscanalsobeasourceofillness.Norovirusishighlyinfectiousandcancauseillnesswhenasfewas10‐100virusparticlesareconsumed.Peoplearetheprimarysourceofnorovirusandwhensomeoneisilltheycanshedmillionsofviralparticlesthroughvomitandfeces.Becauseofthis,peoplewithnorovirusmustbeexcludedfromhandlingfood.Ifafoodworkerisdiagnosedwithnorovirus,itisimportanttocleananddisinfectsurfacesthattheymayhavecontaminated.Thisislikelytorequirehigherconcentrationsofsanitizersthanthoseusedforfoodcontactsanitizing.Noroviruscausesnausea,vomiting,diarrhea,abdominalcrampsandoccasionallyfever24‐48hoursafterinitialcontact.Norovirusoutbreakscanbepreventedbyexcludingillworkers,byproperpersonalhygiene,byproperlycookingfoodandbypreventingcross‐contaminationandbycleaninganddisinfectingsurfacesthatwerecontaminatedbyaninfectedindividual.

Salmonellaisamongthemostcommoncausesofbacterialfoodborneillnessandcanbeanenvironmentalpathogen.Theinfectioncausesdiarrhea,fever,abdominalcrampsandvomiting.Occasionally,Salmonellamaycausebloodstreaminfectionsanddeath.Severecasesmayalsoresultinreactivearthritis.Foodborneillnesssymptomsgenerallyappear12to72hoursaftereatingcontaminatedfood.TheintestinaltractofanimalsistheprimarysourceofSalmonella,thusrawanimalproducts(meat,poultry,eggs,milkproducts)arefrequentlyassociatedwithoutbreaks.BecauseSalmonellasurviveswellinmanyenvironments,manyotherfoodshavebeenassociatedwithoutbreaks,suchasyeast,coconut,sauces,cakemixes,cream‐filleddesserts,gelatin,peanutproducts,chocolateandcocoa,andsoyingredients.Freshfruits,vegetablesandnutscanbecontaminatedduringgrowingifGoodAgriculturalPracticesarenotapplied.

Salmonellaiseasilykilledattraditionalcookingtemperatures,growswithorwithoutair,growsbestathumanbodytemperature,growsverypoorlyatrefrigerationtemperaturesanddoesnot

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growabove115 F(46 C).Unlikemostotherpathogens,SalmonellacangrowatapHaslowas3.7underotherwiseoptimumconditions.Itsurviveswellinfrozenanddryfoods,aswellasindryprocessingenvironments.Attemptstowet‐cleandryprocessingenvironmentshavebeenshowntospreadcontaminationandincreasetheriskofproductcontaminationbecauseofgrowthinenvironmentalnicheslikecracksandcrevicesthatcannotbereachedbysanitizers.ItisbesttokeepdryenvironmentsdrywhenSalmonellaisapotentialconcern.

Shigellacausesdiarrhea(oftenbloody),feverandstomachcramps1‐2daysafterconsumingcontaminatedfoodorbeverages,withsymptomsusuallylasting5‐7days.Shigellaistransmittedprimarilybypeoplewhoareinfected,thusitisessentialforpeoplewithdiarrheatoberestrictedfromhandlingfood.Shigellaisarelativelyfragilebacteriumthatdoesnotsurvivecookingorindryenvironments.Itcanbetransmittedbyfoodssuchasfreshfruitsandvegetables,especiallyifwashedincontaminatedwater.

Staphylococcusaureuscausesarelativelymildillnesswithvomiting,nausea,abdominalcrampsanddiarrhea1‐6hoursaftereatingfoodcontaminatedwithtoxin.Thetoxinisproducedafterextensivegrowthintheproductandisveryheatstable,evenwithstandingprocessingtimesandtemperaturesusedincanningfoods.Whilethetoxinisheatstable,thebacteriumiskilledbymildheat.Toxinproductionisfavoredbythepresenceofoxygen.Thelimitsfortoxinproductionaremorerestrictedthanthoseforgrowth.S.aureusisapoorcompetitor;thus,toxinformationmaynotoccurinfoodsthathavemanycompetitivemicroorganisms,suchasrawfoodsandfoodsthatundergoacontrolledfermentation.

From25–50 ofhealthypeopleandanimalscancarryS.aureusontheirskinandintheirnoses;thusfoodmaybeeasilyre‐contaminated,especiallyifhandledextensively.Ifthisoccursalongwithtemperatureabuse,rapidgrowthandsubsequenttoxinformationislikelyinfoodswithfewcompetingorganisms,suchascookedfoodsorfoodswithlowerwateractivitiesthatinhibitcompetingorganismsbutpermitS.aureusgrowth.

StreptococcusgroupAinfectionsarerarecausesoffoodborneillness.Transmissionthroughfoodcanbeeasilyavoidedbyexclusionofillworkersandmilkpasteurization.

ToxoplasmagondiiisaparasiteandaleadingcauseofdeathfromfoodborneillnessintheUnitedStates,particularlyforbabiesinfectedinthewombandpeoplewithsuppressedimmunesystems.PeopleinfectedwithToxoplasmamaybeasymptomatic,butitcanspreadtoavarietyoforgansincludingthebrain,eyes,heartandothermuscles.Rawmeatproductsandcatfecesaretheprimarysourceofthisparasite.Freezingfoodto F(‐13 C)for24hoursormoreusuallypreventsinfectivity.Cookingmeatstorecommendedtemperaturesalsoisaneffectivecontrolmeasure.

Trichinellaspp.istheparasitethatcausestrichinosis,whichisassociatedwithconsumptionofrawmeatproducts.Inthepast,porkwastheprimarytypeofmeatinvolved;however,transmissionthroughcommerciallyraisedporkisnowrare.Trichinellosisismorecommonlyassociatedwithgamemeat.Aswithotherparasites,Trichinellaissusceptibletofreezingandcooking.

VibriospeciesofconcernforfoodincludeV.cholera,V.parahaemolyticusandV.vulnificus.Becausevibriosareaconcernforseafoodproductsandgenerallynototherfoods,theyarenotaddressedinthistrainingprogram.RefertotheFishandFisheryProductsHazardsandControlsGuidanceorSeafoodHACCPcurriculumformoreinformationonvibrios,aswellasotherregulatoryrequirements.

Yersiniaenterocoliticafoodborneillnessisprimarilyassociatedwithcrosscontaminationfromrawporkproducts.Itisarelativelyuncommonfoodborneillnessforotherfoods.

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Additional Reading FDA.2012.TheBadBugBookFoodbornePathogenicMicroorganismsandNaturalToxins,2ndEdition.FDA2011.FishandFisheryProductsHazardsandControlsGuidance.4thEdition..Painter,JA,RMHoekstra,TAyersetal.2013.Attributionoffoodborneillness,hospitalizations,anddeathstofood

commoditiesbyusingoutbreakdata,UnitedStates,1 8‐2008.Emerg.Infect.Dis.1 (3):407‐415.InternationalCommissiononMicrobiologicalSpecificationsforFoods.1 6.MicroorganismsinFoods5:Microbiological

SpecificationsofFoodPathogens.BlackieAcademicandProfessional,New ork.

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NOTES:

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APPENDIX 5: Sanitation Basics

Chapter 11: Sanitation Preventive Controls addresses theregulatory requirements for sanitation preventive controls.SanitationprocessesarealsoaGMPrequirement.Thisappendixprovidesmoredetailonthebasiccleaningandsanitizingprocess.This appendix includes some text from Chapter 11 becausesanitation preventive controls build on the sanitationfundamentalsdiscussedhere.

Astrongsanitationprocessisafundamentalprerequisiteforastrongfoodsafetyprogram.Withoutanadequatesanitationprocessfood

Definition: Pest: Any objectionable animals or insects including birds, rodents, flies, and larvae. ‐ 21 CFR 117.3

The EPA definition of pest includes objectionable microorganisms. Sanitary practices help to keep all of the above under control.

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may become contaminated with microorganisms that couldendangerpublichealthorcausespoilage.Majorrecallshavebeencaused by sanitation lapses that led to contamination orrecontaminationoffood.

Sanitation removes the food residue that both attracts andsupports the growth of pests within and outside of the facilityenvironment.Pestsneedthesamethingsthatpeopledotoliveandreproduce–water,air,foodandhabitat.Throughsanitation,food,habitatandsometimeswaterareremovedsopestsarelesslikelytobeattracted.

Inadditiontopests,verysmallamountsoffoodallergenscancauseadverse reactions in food allergen sensitive individuals. Anadequatesanitationprogramisessentialtopreventallergencross‐contactbetweenfoodsthatcontainallergensandthosethatdonot.

A strong sanitation program helps assure that the productsproduced are both safe and wholesome. Additionally, a robustsanitation programmay also address quality concerns that areoutsideofthefoodsafetyprogram.

Sanitation Process

Thecleaningmethodshouldtakeintoaccounttheequipmentbeingcleaned,aswellasthehazardsthatmustbecontrolled.Wetcleaningisfrequentlythemosteffectivewaytoremovefoodresidue,especiallywhenthecleaningsolutionisselectedwiththeparticularfoodresiduein mind. Manual, foam/gel, Clean‐In‐Place (CIP) and Clean‐Out of‐Place(COP)methodscanbeeffectiveinwetcleaningsituations.

Many types of foods and raw materials are handled in a dryenvironment–e.g.,cereal,bakingproducts,dairypowders,packagingetc.Drycleaningmethodsshouldbeusedandenvironmentsshould

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be maintained in a dry condition to prevent establishment ofenvironmental pathogens. Dry cleaning methods typically usemechanicalactionandarediscussedafterwetcleaning.

Allergens and microbial contamination can be carried as dust bycompressedairorsuspendedinliquidwherehighpressurewaterorsteam is used. The possibility that these hazards will re‐enter theprocessingstreamisverydifficulttocontrol.Thesemethodsshouldbeavoidedunlesscapturesystems,suchasvacuums,areavailable.

Wet Cleaning

Before work areas and equipment can be sanitized, they must becleaned.Usingasanitizeronadirtysurfacecanbeineffectivebecausethe food residue may bind the active ingredients. Therefore,

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sanitationisusuallyatwo‐stepprocess–cleanandthensanitize.Inthefoodandbeverageindustry,cleaningconsistsofseveraldistinctsteps, including pre‐cleaning, pre‐rinsing, washing, post‐rinsing,inspectingandsanitizing.

Pre‐cleaning involves use of a broom, brush, squeegee or otherappropriatetooltosweepupfoodparticlesandresiduefromsurfacesprior to pre‐rinsing. Pre‐clean can decrease the time and chemicalrequirements forthe fullcleaningprocess.Pre‐rinsingwithpotablewatertoremoveanyremainingsmallfoodparticlesandresiduewetsandpreparesthesurfacefordetergentapplication.

Washinginvolvesusingtheappropriatedetergentbasedonthenatureof the soil, the type of surface to be cleaned and the type cleaningmethod used (e.g., manual, foam/gel, CIP, COP). Detergent not onlyhelpstoremoveresiduesfromsurfaces,butalsohelpstosuspenditsoitcanberemovedduringrinsing.Theeffectivenessofacleaningprocessis influenced by four major factors – chemical concentration,mechanical action, time and temperature. Follow themanufacturer’sinstructions for detergent contact time and recommendedtemperaturestobalancethesefourfactors.

In the post‐rinse phase, potable water removes detergent andremaining loose soil on the surfaces. This process prepares thesurfacesforsanitizing.Alldetergentsmustberemovedbecausetheymayinactivatecertainsanitizers.

Inspectingthecleanedsurfacescanprovide immediate informationabouttheeffectivenessofthecleaningprogram.Forexample,ifthereisevidenceofresiduesorwaterbeading,thesurfacesneedtobere‐cleaned.Toolssuchasflashlights,black‐lightsandspotlightscanhelpto identify left over soil, which indicates ineffective cleaning. ATP,microbiological andprotein swabscanalsobehelpful to verify theeffectivenessofcleaning.Ifasurfaceishardtoreachortosee,itisalsolikely to be hard to clean. Dismantling equipment is sometimesnecessarytoensurethatthecleaningprocessaccomplisheswhatyouthinkitisdoing.

Sanitize to inactivate pathogens after the surfaces are cleaned andrinsed. All sanitizers must be used in accordance with the EPA‐registered (or similar registration in other countries) label useinstructions,includingapprovalforuseinfoodestablishments.

Areputablechemicalcompanyproviderisagoodresourceforfurtherinformationonalloftheseareas.

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Therearedifferentwaysinwhichfoodresiduescanberemoved:

Manualmethodsinvolvewashingobjectsbyhandusingabucket(orsink)toholdthecleaningsolutionandabrushorothertooltoscrub.Itemscanbeleftinasoaktanktoincreasethecontacttimeandreducetheamountofscrubbingneededtoremovesoils.

Foam/Gelmethodsinvolvemoreconcentratedcleanersthatcanbeappliedtothesurfaceofsoiledequipment.Thehigherconcentrationcanreducethetimeittakestoremovesoil.Awatersprayremovesthecleanerandloosenedsoils.

Mechanicalmethods include spraywashers, CIP systems and COPsystems.Spraywasherscanbeconveyor (similar toacarwash)orbatch (cabinet washers). CIP systems clean internal surfaces ofproduction equipment without disassembly. Cleaning solutionscontactthesurfacesbypumpedcirculationandautomaticspraying.COPsystemscleandisassembledequipmentpartsthatareplacedinatankwherethecleaningsolutioncirculates.Foranymechanicalprocess,itisimportanttofollowdefinedprocessparameters (e.g., concentration,velocityetc.) toassureadequacyoftheprocess.Thisisdiscussedinthevalidationsectionbelow.

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Sanitary design is an important consideration to prevent productcontamination. An example of a potential source of environmentalcontamination is thehollow rollerona conveyor illustratedabove.Theequipment looks cleanbutwhen the shaft is removed,organicmatterthatcansupportmicrobialgrowthisevidentinthecenteroftheroller.Thistypeofsitemaybe impossibletocleanandsanitizewithanormalcleaningprocedure.

Redesign of equipment to eliminate hollow rollers is the preferredsolutiontopreventthistypeofnicheinready‐to‐eatfacilitiesthatusewetcleaningmethods.Cracksandcrevicesinequipment,floorsandwallspresentsimilarcleaningandsanitizingchallenges.Therequiredelements for cleaning – time, temperature, mechanical force andchemicalconcentration–simplycannotbereliablyappliedinthesetightareas.Ifsuchequipmentisused,keepingitdryisimportanttoprevent a potential source of contamination. Disassemblingequipmentforthoroughcleaningmaybenecessaryiftheequipmentcannotberedesigned.Referencesonsanitarydesignareprovidedattheendofthechapter.

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Dry Cleaning

Wherewet cleaning increases the riskof environmental pathogenssuchasSalmonella,drycleaningmethodsshouldbeused.Toolsusedfordrycleaningcanincludevacuums,scrapersandbrushes.Thetoolsmustbehygienicallydesignedandingoodrepairwithoutcracksetc.Hygienic zoning (see Appendix 6) should be present for effectiveapplicationofdrycleaning.Forexample,itisrecommendedthatthedry cleaning tools be dedicated to the area or room that is beingcleaned.

During dry cleaning, food residue is removed using physical ormechanical action, such as vacuum systems, brushing and blastingwith high pressure. As previously discussed, it is essential thatcleaning does not spread hazards (e.g., pathogens or allergenicmaterial)toothersurfaces.Capturesystems(e.g.,vacuums)mustbeused for some of these techniques. Dry cleaning of enclosedprocessing lines may use push‐through material; e.g., for allergencleaning.Equipmentshouldbeascleanaspossibleusingdrymethodsbeforepush‐throughisused.

An area that has been dry cleaned should be inspected foreffectiveness of the cleaning. The area may not be shiny andcompletely free of dust; however, there should be very littleremaining residue on the equipment. Because some food residuesmayremain,theeffectivenessofdrycleaningprocedurestoremovefood allergens must be considered. Each facility application isdifferent, therefore, thismust be evaluated on a case‐by‐casebasis(SeeChapter10:FoodAllergenPreventiveControls).

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Cleaning and sanitizing are required under GMPs and certainelementsof thesepracticesmaybea sanitationpreventivecontrol.Cleaning is required before sanitizing can be effective. Certainfacilities arebest cleanedusingdry cleaning techniques topreventformation of environmental niches that can harbor environmentalpathogens.Other facilities or locationswithin facilities requirewetcleaningandsanitizingtoensuresanitaryoperations.

Additional Reading SeetheFSPCAwebsiteforupdatedinformationonGMPandsanitationtrainingprograms.

3‐ASanitaryDesignStandardsAmericanMeatInstitute.2011.SafeEquipmentDesignChecklist–AmericanMeat

Institute.2003.SanitaryEquipmentDesignBakka,R.L.andT.Boufford(ed.).2004.MakingtheRightChoice–Cleaners.EcolabInc.,FoodandBeverageDivision.St.Paul,MN

Beuchat,L.etal.2011.PersistenceandSurvivalofPathogensinDryFoodsandDryFoodProcessingEnvironments.ILSIEuropeEmergingMicrobiologicalIssuesTaskForce.Boufford,T.(ed.).2003.MakingtheRightChoice–Sanitizers.EcolabInc.,FoodandBeverageDivision.St.Paul,MN

Cramer,M.M.2006.FoodPlantSanitation:Design,Maintenance,andGoodManufacturingPractices.Taylor&Francis.

Fredell,D.andT.Boufford(ed.).2007.MakingtheRightChoice–SanitationProcess.EcolabInc.,FoodandBeverageDivision.St.Paul,MN

EnvironmentalProtectionAgency.Toleranceexemptionsforactiveandinertingredientsforuseinantimicrobialformulations(Food‐contactsurfacesanitizingsolutions).40CFR180. 40.

GrahamDJ.2006.SnapshotsinSanitaryEquipment:DevelopinganEyeforHygiene.FoodSafetyMagazine.

Graham,D.J.2004.UsingSanitaryDesigntoAvoidHACCPHazardsandAllergenContamination.FoodSafetyMagazine.

Graham,D.J.200 .Equipmentsanitarydesignconsiderationswhenpurchasing.FoodSafetyMagazine.

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GroceryManufacturersAssociation.200 .ControlofSalmonellainlowmoisturefoods.AvailableatGroceryManufacturersAssociation.EquipmentDesignChecklistforLowMoistureFoods.

Imholte,T.J.andImholte‐Tauscher,T.K.1 .EngineeringforFoodSafetyandSanitation.2nded.TechnicalInstituteofFoodSafety.

Marriott,N.G.andGravani,R.B.2010.PrinciplesofFoodSanitation.2010.5thed.AspenPublications.

NationalSeafoodHACCPAlliance.2000.SanitationControlProceduresforProcessingFishandFisheryProducts.1stedition.

Pehanich,M.2005.Designingfoodsafetyintoyourplant.FoodProcessingSanitaryDesign.Website.

UnitedFreshProduceAssociation.2003.SanitaryEquipmentDesignBuyingGuide&Checklist.

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APPENDIX 6: Hygienic Zoning and Environmental Monitoring

Chapter11:SanitationPreventiveControlsintroducedhygieniczoningasapotentialpreventivecontrolandenvironmentalmonitoringasaverificationactivityforsanitationandzoningpractices.Thisappendixprovidesmoreinformationonhygieniczoningandenvironmentalmonitoring,whichmaybeofinteresttoparticipantswhohavenotattendedcoursesonthesetopics.SomeoftheinformationinthisappendixincludestextfromChapter11becausesanitationpreventivecontrolsbuildonthefundamentalsdiscussedhereincertainfacilities.

Environmentalmonitoringisusedtoverifythecontrolprogramsdesignedtosignificantlyminimizeorpreventenvironmentalpathogencontaminationofready‐to‐eatfoodsareworkingeffectively.Sanitationmaynotbetheonlycontrolnecessarytopreventrecontaminationofexposedready‐to‐eatfoods,especiallywhenrawandready‐to‐eatproductsareproducedinthesamefacility.Thissectiondiscussesdifferentpathwaysforenvironmentalpathogencontamination,thebasicprinciplesfordividingafacilityintohygieniczones,theobjectivesofenvironmentalmonitoring,howtoimplementaprogram,aswellasinvestigationandcorrectiveactionsappropriatewhenenvironmentalpathogensaredetected.Usefulrecordsforcapturingenvironmentalmonitoringresultsarealsodiscussed.

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Thefirststepinunderstandingenvironmentalpathogensistounderstandhowmicroorganismsbehaveinafoodenvironment.Simplistically,therearetwobasictypesofmicrobialcontaminants–transientandresidentmicroorganisms.Transientmicroorganismscanenterafoodestablishmentoningredients,rawmaterials,personnelandotherincomingitems.Essentiallytheyhitchhike.Normalcleaningandsanitizingshouldremovetransientstrainssotheydonotpersistorbecomeestablishedinafoodfacility.Evenwithgoodsanitationprocedures,transientstrainswillappearfromtimetotimeinanestablishmentandmaybedetectedoccasionallythoroughtesting.Thisistobeexpected.

Conversely,residentmicroorganismsbecomeestablishedinthefoodprocessingenvironment.Theymayfindtheirwayintonooksandcrannies,referredtoasenvironmentalnichesorharborages,andpersistforlongperiodsoftime.Thesenichesaredifficulttoclean,thusaresidentstrainmayformacolonythatperiodicallycontaminatesfood.Theobjectiveofhygieniczoningistoreducethepotentialfortransientorganismstoentersensitiveareasinthefacility,suchaspackingareaswhereaready‐to‐eatproductisexposedtotheenvironment.Theobjectivesofanenvironmentalmonitoringprogramare:

1) toverifythathygieniczoningeffortsareeffectiveand2) todetectenvironmentalnichesandthustargetcorrective

actiontoremoveresidentstrains.

Thisrequiresvigilantsanitationpracticesandanunderstandingoftheimportanceofsettinguparigorousprogramtodetectresidentstrains.

Theneedandextentofzoningandenvironmentalmonitoringdependsontheproduct.Typicallythistechniqueisappliedin

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facilitiesthatmakeready‐to‐eatproducts.Forexample,theneedsforaflourmillversusaready‐to‐eatrefrigeratedfoodfacilityversusacanningfacilityareverydifferent.

Eachfacilitymustdeterminetheneedforandscopeofazoningprogrambasedonpotentialrisktotheirproducts.Theassessmentshouldtakeintoaccountthestructureitself,personnel,packagingandingredienttrafficflows,andanycrossoverareas.Itshouldalsoconsiderpotentialcontaminantsfromrawmaterials,airflow,supportareasandactivitiestakingplaceinthefacility. oningmaybeimplementedinafacilityforfoodsafetyorforqualityreasons(e.g.,tocontrolmoldcontamination);however,thesanitationpreventivecontrolsneedonlyaddressenvironmentalpathogensthatarerelevanttotheproduct(typicallyready‐to‐eatfoods)beingproduced.

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uestionsthatmaybeconsideredindeterminingifzoningand

environmentalmonitoringisusefulinafacilityincludethefollowing:

1. Doestheproductformulationhaveanintrinsicpropertythatwouldkilltheenvironmentalpathogenofconcern

Ifanintrinsicpropertykillsenvironmentalpathogens(e.g.,veryhighlevelsofacidasinavinegar‐basedsauce),environmentalmonitoringmaynotbewarranted.Validation(seeChapter13:VerificationandValidationProcedures)oftheeffectivenessofsuchintrinsicpropertieswouldbeneededtoensurethatthepathogenisindeedcontrolledbytheintrinsicproperty.

2. Istheproductoringredientassociatedwithpathogencontamination

Thepotentialforapathogentobecomeestablishedintheprocessingenvironmentincreaseswhenaningredienthasahistoryofpathogencontamination.Salmonellahasahistoryofenvironmentalcontaminationinlowmoisturefoodssuchascereals,peanuts,nutsandnutbutters,spices,driedherbs,milkpowerandchocolate.L.monocytogeneshasahistoryofassociationwithready‐to‐eatfoodoutbreaks,especiallythosethatarerefrigerated.

3. Doestheproductreceiveavalidatedprocesscontroldesignedtokillenvironmentalpathogens

Avalidatedprocesscontrol,suchascooking,reducestherisk.

4. Istheproductexposedtotheenvironmentafterakillstepandbeforepackaging

Iftheunpackagedproductisexposedaftercooking,thereisanincreasedriskforrecontamination.Exposedready‐to‐eatfood

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handlingshouldtakeplaceinanenvironmentthathasstricterhygienestandards,withperiodicenvironmentalmonitoringtoverifythathygienecontrolsareadequatetominimizethepotentialforproductrecontaminationwithenvironmentalpathogens.

5. Areready‐to‐eatingredientsusedtoproduceaready‐to‐eatproduct

Sometimesthereisnokillstepinaprocesswhenready‐to‐eatingredientsarecombinedtoproduceaready‐to‐eatproduct.Aswithproductexposedtotheenvironmentafterakillstep,enhancedhygienecontrolsarewarrantedtoreducetheriskofcontaminationwithenvironmentalpathogens.

6. Doesa refrigeratedready‐to‐eatproduct support thegrowthofListeriamonocytogenes

L.monocytogenesoutbreakstypicallyinvolvefoodsthatsupportthegrowthoftheorganism.SanitationpracticesthatreducetheprevalenceofL.monocytogenesintheenvironmentareessentialtoavoidenvironmentalcontaminationoftheseproducts.Environmentalmonitoringisusedtoverifythatsanitationpracticesareadequatetomaintainanenvironmentthatisunlikelytocontributetoproductcontamination.ManyfacilitiestestforListeriaspp.asanindicatorforL.monocytogenes.

Hygienic Zoning

Itisusefultodefinehygienerequirementsfordifferentareasbasedontheriskforcontaminatingproduct.Identificationofthefollowingmaybeuseful:

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x Non‐manufacturingareasincludemaintenanceareas,officesandemployeeareassuchascafeterias.TheseareasshouldmeetbasicsanitationrequirementsbutarenotrequiredtomeetGMPs.Individualsworkingintheseareas,however,shouldunderstandthatmorestrictrequirementsforsanitationapplyinotherareasofthefacility,andthattheymustcomplywiththoserequirementswhentheyenterotherareas.

x Transitionareasmayincludeanentryroom(ordoor),lockerrooms,andsimilarareasthatenterintobasicGMPareas.Smocks,hairnets,footwearandotherpersonalequipmentrequiredforentryintoGMPareasshouldbeavailableintransitionareas.Requirementsforentryshouldbelistedandavailabilityofequipmentsuchashandwashingstations,footfoamingstationsetc.asrelevanttoavoidcontaminationofthefacilityshouldbeconsidered.

x BasicGMPareasincluderawreceivingandstorageareas,aswellasgeneralfoodprocessingareas.ThesemustbekeptcleantomeetbasicGMPrequirements.Separationofrawingredienthandlingareasandtoolsfromthoseusedforcookedorpasteurizedproductisnecessarytopreventcross‐contamination.Thisincludesusinglinearflowofproductandtraffic,whetherbyfoot,cart,forkliftorothermeans,topreventcross‐contamination.Ifafacilityhascrossoverareasthatcannotbeengineeredout,specialattentionmustbepaidtopreventivecontrolsinordertoavoidaccidentalcross‐contamination.

x Primarypathogencontrolareasarethosewherecooked,pasteurizedorready‐to‐eatproductsareexposedtotheenvironment,e.g.,packagingareasforsuchproducts.Morestringentsanitationrequirementsshouldapplytotheseareastominimizethepotentialforcross‐contamination.Controllingpersonnelaccess(e.g.,throughcolorcodeduniforms,specialfootwareetc.)anddedicatingequipmentsuchascartsandforkliftsmayalsobeusefultokeepenvironmentalcontaminantsfromhitchhiking’intothismoresensitivespace.

x Sensitive/highhygieneareasincludethoseareasproducingfoodforsensitivepopulationssuchasinfants,andfoodsdedicatedtoclinicalsettings.

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Itisusefultopostacolor‐codedfacilitymaptodifferentiatehygieniczonesandshowingpropertrafficflowstohelpreinforcezoningandcompliance.Suchamapcanbeusedtoorientnewemployeesandvisitorsandtoremindeveryoneabouttheneedtominimizecross‐contamination.Implementcontrolsforaccessandentryintocontrolledhygieneprocessingareas.Defineandenforceproperattireforeachzoneofthefacility,determinewhocangowhereandtheentryrequirements.Forexample,dotheyhavetowearamasktogointosensitiveareas Whataboutcaptivefootwear Idealtransitionareashavesignsandphysicalbarriersthatforcetheproperrequirementssuchasturnstiles,airshowersandhandwashingstationsatentrythatcannotbebypassed.Picturesonsignsaremosteffective.

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Environmental Monitoring

Theprimaryobjectivesofenvironmentalmonitoringaretoverifyorconfirmtheeffectivenessofsanitationandzoningcontrolsandtodirectactivitiestoimprovecontrol.Environmentalmonitoringisusefulwhentheenvironmentneedstobecontrolledtopreventmicrobialcontaminationandwhentestingwillbebeneficialtoverifycontrolofthepathogenofconcern.

Aneffectiveenvironmentalmonitoringprogramdiligentlytriestofindthepathogenorindicatorofconcernsothatcorrectionscanbemadebeforeproductiscompromisedandtheeffectivenessofinterventionscanbeevaluated.Forexample,arobustenvironmentalmonitoringprogramcanassistwithdetectionofthepresencenichepathogensanddifferentiatethemfromtransientstrains.Thiscancreateabetterunderstandingofhowtoreacttofindings.Arelentlessseek‐and‐destroycultureasitrelatestoenvironmentalmonitoringisessential.

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Anenvironmentalmonitoringprogrammustbedesignedspecificallyforthefacilityandconsidertheproductsmade,theingredientsused,anyhistorywithpastenvironmentalpathogensandotherrelevantfactors.Itisabiasedsamplinginthatitlooksforworst‐casesamplingsitesandtriestofindproblemareas,ratherthanarandomsamplingprogramthattriestoidentifythe“average”situation.Thismayseemriskyatfirstandsomemayquestion“WhywouldItrytofindanenvironmentalpathogeninmyfacility ”Theansweris–youhaveabetterchanceoffindingapotentialpathogenintheenvironmentbeforeyouwouldfinditinproductandthismaypreventamajorrecallorworse–anoutbreak.Investigationsofseveraloutbreakssuggestthatthefacilityenvironmentwasthesourceoftheoutbreakstrains

Salmonellasurvivesverywellinadryenvironment.Whenwaterisintroducedandnutrientsareavailable(e.g.,fooddust),Salmonellacanmultiply,whichincreasesthechanceofitbeingtransportedtoanotherareaeitherbythemoisturemovementitselforbycontaminatingamobileobjectorperson.Salmonellaoutbreaksthoughttoinvolveenvironmentalcontaminationhavebeenassociatedwithanumberofdryfoodproductsincludingbakerymixes,peanutbutter,nutsandbreakfastcereals.Therefore,environmentalmonitoringforSalmonellainmanyready‐to‐eat,lowmoisturefoodprocessingenvironmentsisfrequentlyneeded.

Listeriamonocytogenesoutbreaksareassociatedwithrefrigerated,ready‐to‐eatproducts,thusenvironmentalmonitoringtodetectthepotentialforrecontaminationisfrequentlyneeded.Listeriaspp.monitoringisusedasamoregeneraltestinsomefacilitiesbecauseitiseasiertodetectapotentialproblem.However,testingtheenvironmentforL.monocytogenesmaybeappropriateinsomefacilities.Thedecisionshouldbemadeinconsultationwitha

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qualifiedfoodmicrobiologistwhounderstandsthemicrobialecologyofthefacilitytype.

Sincetheobjectiveofenvironmentalmonitoringistodetectpotentialsourcesofcontamination,samplingtypicallyfocusesontheareasofgreatestconcern.Morefrequentsamplingtakeplaceinprimarypathogencontrolareas.Samplingofnon‐manufacturingareasisrare.

Withineacharea,theactualsamplinglocationisdescribedintermsofzones.Zone1representsfoodcontactsurfaces,suchasvessels,conveyors,utensilsandevenhandsthatcomeintodirectcontactwiththefood.

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Zone2includesareasadjacenttofoodcontactsurfacesandaresometimesreferredtoasindirectproductcontactsurfaces.Examplesarebearings,equipmentpanelsoraprons.

Zone3includeseverythingelsewithintheproductionorprocessingarea–floors,walls,ceilings,drainsandotherequipment.

Zone4encompassesallothernon‐productionareasofafacility,suchashallways,maintenanceshopsandemployeewelfareareas.

Bestpracticesfocusmonitoringin ones2,3and4locations.Thesezonestendtohaveahigherfrequencyofcontamination,thussamplingthesezonesincreasesthelikelihoodthatapotentialcontaminationsourceisdetectedbeforeitisfoundinproduct.Earlydetectionandcorrectionhelpstopreventcontaminationofproductcontactsurfaces/areas( one1). one1samplingisinfrequent,butwhenthisisdone,productshouldbehelduntilresultsarefoundtobenegativetopreventthepotentialforarecallsituation.

Personnelmustbetrainedtoconductenvironmentalsamplingandmusthaveasenseforwhentodeviatefromtheplanbasedonobservationsorspecialevents.Therighttoolsallowsamplingintocracks,crevices,highareas,largefloorareas,drainsaswellasdryscrapingsandair.

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Prepareamapofthefacilitywithalldrainsdemarcated.Determineasitelistforthefacility.Ensuremoresamplesfrom ones2and3aretakeneachtime,withafewfrom one4.

Takeswabsduringproduction,atleast3hoursin.Samplesmaybecompositedtoreducecostsbytakingindividualsamplesfromeachsiteandcombiningthemtoformthecompositesample.Donotusethesamespongeformultiplesamplesitesasthiscouldspreadpotentialcontamination.

Increasesamplingwhenfocusingonwater,harborageandhightrafficareasandsitesthataremorelikelytobeasourceofcontaminationbasedonequipmentandplantinfrastructureconditions.Itisgoodpracticetosanitizethesiteaftersampling.

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Detectionofapathogenina one1samplerequiresimmediateactionbecausethesafetyoftheproductproducedonthelineisinquestion.Expertconsultationisadvisedwhenthisoccurstoevaluatedatacollectedovertime,sanitationpracticesandotherfactorsrelevanttodeterminingthedispositionofthelot.

Forindicatormonitoring,thetargetandactionlevelsshouldbeestablishedafterbaselineshavebeenestablished.Itisdifficulttointerpretresultsifthereisnobasisforcomparison.Facilitiesthatmakethesameproductcanhaveverydifferentprofiles.Baselinedatacollectiontypicallyinvolvesahigherlevelofsamplingoveradefinedperiodoftimeandisanattempttocaptureasnapshotofthestable/routineoperation.Severalsetsofdatamaybecollectedtocoverseasonalvariability.Ifallsitesarenotsampledateachsamplingtime,arotationsystemcanbeused.Becausetheobjectiveoftheprogramistoproactivelyidentifypotentialsourcesofcontamination,itisadvisabletosampleworst‐caseconditionsiftheyareobserved.Thesecouldincludestandingwater,dripareasfromroofleaks,accumulatedproductetc.

Samplingfrequencyduringtheinitialmonthsoftheprogrammaybeincreasedtoaidinestablishinganormforthefacility,takingintoaccountfactorssuchasseasonality,weather,adjacentestablishmentsandpersonnelchanges.

Athree‐phasedapproachtosamplingisabestpractice:1)routinesamples(focusonhighrisk),2)investigationalsamplesand3)followupsamplingtoconfirmtheeffectivenessofcorrectiveactions.Thefrequencyofsamplecollectionmaybeincreasedordecreasedbasedonareviewofthefacility’shistoricaldata,adeterminationoftrafficpatternsandproductrisk.

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Findingapositiveenvironmentalsampleisanopportunitytoinvestigatetoseeifsomethinghasfailedinthecontrolprogram.Keepinmindthatsomepositiveresultsaretransientmicrobes,thusnochangemaybenecessary.Conversely,somepositiveresultsrequireactiontopreventproductcontamination.

Agoodinvestigationisacombinationofobservation,inspectionandintensifiedsampling.Ifthepositivesamplewasacomposite,thenresampletheentirearea.Thesesamplesaretestedindividuallytohelpidentifyandisolatetheproblemarea.Inadditiontoretesting,observeequipment(assessableanddisassembled),process,personnel,andcleaningandsanitizingtodiscoverfactorsthatmayhavecontributedtothecontaminationevent.Itisalsoimportanttolookattheflowofmaterialstodetermineifcrossflowsareanissue.Basedontheinvestigation,changesinproceduresmaybeneeded.Sometimescorrectiveactionmayfocusonanicheinthefacilityorequipmentthatneedstoberemoved,correctedorcleaned.Newproceduresmaybeneeded,andpersonnelmayneedtobetrainedonthesechanges.Oncethenecessarycorrectionismade,adeepcleaningandsanitizingregimenshouldfollow.Itisthennecessarytoconfirmeffectivenessthroughrepeatedintensifiedsamplingforanextendedperiodoftime.Re‐sampleextensivelypostcleaningandsanitizing,duringoperations,atchangeover,andshutdownsoverextendedperiod.

Ifrepeatedpositivesoccurafteranevent,thecorrectiveactiontakenisnoteffective.Thismaybeduetoaharborageornicheareathatwasnotaddressedordiscovered.Reviewfacility,equipmentandoperationalcontrolstoensurethatallpossiblemeasureshavebeentaken.Facilitieshavehadtohaltproductionincertainareasbecauseofenvironmentalnichesthatwerenotpossibletoeliminate.

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Rooforwaterleaks,floordrainback‐upsinexposed‐productareas,constructionorequipmentinstallation,andtransitionbetweenconstructionandproductionareascanincreasetheprevalenceofenvironmentalpathogens.Proceduresshouldbeinplacetoprotectprocessingareasandproductduringsuchevents.

Forsituationsinvolvingleaksandentryofwaterindryenvironments,environmentalmonitoringforSalmonellaisadvisable.Takingtheseswabsimmediatelyandbeforecleanupisusefulbecausethislikelyrepresentstheworstcasesituation–ifnoSalmonellaisdetectedintheseswabs,theenvironmentmaynotbecompromised.However,iftheorganismisdetected,immediateactionshouldbetakentosanitizetheareawithoutextensiveuseofwater,whichislikelytomakethesituationworse.

Duringconstructionevents,trafficpatternsshouldbeevaluatedtominimizeapotentialsourceofcontamination.Dustandtrafficshouldbecontrolledinintheeventofconstruction.Uponcompletionofconstructionactivities;theareashouldbecleanedandsanitized,andswabsshouldbetakenbeforeproductionbeginsagain.Additionalenvironmentalmonitoringfollowingtheseeventswillhelpverifyrestorationofcontrols.

Trackingandtrendingofenvironmentalmonitoringdataisabestpractice.Thereportingformatfortheresultswillinfluencetheinformationprovided.Ifyouaregoingtotheeffortofcollectingenvironmentalmonitoringdata,makesurethatyoumaximizethevalueoftheinformationsothatyoucanuseittoprotectyourproductandfacility.Resultsinanactionableformatmaximizethevalueofthedata.Forexample,spreadsheetshelpwithidentificationoftrendsforroutineandintensifiedmonitoring.Facilitymappingcanalsobeusedtoshowwherepositivesoccurandtodetermineifthepositivesareinthesamelocation,whichcouldindicatean

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environmentalniche.Resultsreportedonamapcanbeusedtodemonstratetheeffectivenessofpreventivecontrolsforenvironmentalpathogens.

Theaboveslideisanexampleofusingaspreadsheettoreportenvironmentalmonitoringresultsovertime.Thefacilityhasthreeareas.Twenty‐fiveswabsaretakenineachareaonaweeklybasistoestablishabaseline.Notethatthenumberofsamplestakenandthefrequencywillvaryconsiderablybetweenfacilities.

Resultsfromenvironmentalsamplingareplottedonagrid,indicatingdifferentsamplingareas.Thecirclesindicatethelocationofpositiveswabsandthecircle’scolorrepresentsdifferentweeks.

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Thisenhancedmaphasthesameplottingofthepositiveresults,butalsoshowsinfrastructure(e.g.,astructuralcolumn)andtrafficflow.Thefacilitydeterminedtherewasalikelycontaminationsourceabovethecolumnandconductedadditionalinvestigationtoidentifyandeliminatethesource.Itwasdiscoveredthatmoisturedrippingdownalongthecolumntransferredcontaminationthroughagapbetweenfloors.ThemoisturesplashedfromthecolumntothefloororotherstructuresinthedifferentareaandwasthentransferredbyemployeetraffictoAreaC.

Pullinformationtogetherfromallofdatasourcesavailable,andthenreconstructwhatwashappeningwhentheswabswerecollected.Thismayinvolvereviewofproductionschedules,sanitationschedules,visitorlogsandotherinformationsourcestodetermineif

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somethingoutoftheordinaryoccurred.Basedontheinformationgathered,identifyapotentialsourceofcontamination,thenconfirmwhatyoubelievewashappeningthroughadditionalobservationordatagathering.Itisimportanttodocumenttheconclusionoftheinvestigation,documenttherootcauseandtakecorrectiveactiontofixtheissue. ourultimatelygoalistoidentifyarootcausethatmakessensebasedonavailableinformation,thentakeactionanddemonstratetheactionwaseffective.

Negativeresultsaregood,toapoint.However,theycanprovideafalsesenseofsecurity.Mostfacilitiesdetectenvironmentalpathogensfromtimetotimeandtheseareusuallytransientstrains.Ifenvironmentalmonitoringresultsarealwaysnegative,askwhytheresultsarealwaysnegative.Remember,testingisnota“control”–positiveresultsmayalsobegoodtoapointbecauseyoucanactonthembeforeapathogenisdetectedinaproduct.

Theenvironmentalmonitoringprogramshouldbereviewedandrefreshedatleastannually.Witharobustprogram,modificationstakeplaceasneeded,suchaswhenindicatedbycorrectiveactionsandwhenthereareingredient,processorequipmentchanges.Ifthereareconsistentlynopositivefindingsandthisisnotwhatshouldbeexpected,thismayindicatethattheprogramisnotbeingmanagedwithanaggressiveseekanddestroyattitude.Mostknowledgeableauditorsaregoingtobeskepticalofanenvironmentalmonitoringprogramthatneverhasapositiveresultinthelongterm.

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Hygieniczoningcanbeusedtominimizesanitationissuesinafacility.Environmentalmonitoringisausefultechniquetoverifytheeffectivenessofsanitationprogramsandthesearerequiredinfacilitiesthatproduceready‐to‐eatproductsthatareexposedtopotentialenvironmentalcontamination.

Additional Reading Beuchat,L.etal.2011.PersistenceandSurvivalofPathogensinDryFoodsandDry

FoodProcessingEnvironments.ILSIEuropeEmergingMicrobiologicalIssuesTaskForce.GroceryManufacturersAssociation.200 .ControlofSalmonellainlowmoisturefoods.

InnovationCenterforUSDairy.2012.PathogenControlProgramTools.InternationalCommissiononMicrobiologicalSpecificationsforFoods.2002.

Samplingtoassesscontroloftheenvironment,inMicroorganismsinFoods7:MicrobiologicalTestinginFoodSafetyManagement.KluwerAcademic/Plenum

Kornacki,J.L.2010.PrinciplesofMicrobiologicalTroubleshootingintheIndustrialFoodProcessingEnvironment.SpringerScience BusinessMedia.

Pehanich,M.2005.Designingfoodsafetyintoyourplant.FoodProcessingMarch7,2005

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