FSMA Standardized Curricula Update
FSMA Standardized Curricula UpdateRobert Brackett, Ph.D.Illinois Institute of TechnologyInternational Citrus & Beverage ConferenceClearwater Beach, FLSeptember 22, 2016
Background2
FSMA is historical Involves creation of a new food safety systemBroad prevention mandate and accountabilityNew system of import oversightEmphasizes partnershipsEmphasizes farm-to-table responsibilityDeveloped through broad coalition
Why the Food SafetyPreventive ControlsAlliance?4
Introduction Background FDA recognized the need to assist the regulatedindustry to comply with FSMA Decision was made to follow the Seafood HACCPAlliance model FSPCA followed similar format, but with differentstructure to account to various commodities includedin FSMA FSPCA public/ private partnership to achieve this goal Based at IIT Institute for Food Safety and Health5
Why the Institute forFood Safety and Health?6
Why IFSH? Largest and oldest of FDA/CFSAN’s Centers ofExcellence Founded in 1988 as National Center for Food Safety andTechnology Reorganized as IFSH in 2011 Long-standing Public/Private Partnership Expertise in food safety and food processing7
IFSH – At a Glance Four research centers with primaryfocus: Food processing safety Nutrition research National security related to food Holds consortium betweenIIT/FDA/Industry (68 Members)IIT Main Campus, State Street, Chicago, IL Location for FDA’s Division of FoodProcessing Science & Technology 100 Scientists 50/50 IIT/FDA 137 IIT Graduate Students Masters and Professional Certificatesin FST and FPE‒ Students gain valuable researchexperience with FDA on researchprojectsIIT Moffett Campus, Bedford Park, IL
IFSH CentersU.S. FDADFPST/CFSANNationalCenter forFoodSafety andTechnologyCenter forProcessingInnovationSchool ofAppliedTechnologyInstitute for FoodSafety and HealthCenter forNutritionResearchCenter forSpecialtyProgramsDepartmentof FoodScience andNutrition
IFSH & Industry CollaborationSmuckers10
FSPCA Public/Private Partnership11
FSPCA – Public/Private Partnership12
FSPCA Management Entity Partners Institute for Food Safety and Health (IFSH) Hosts the website for Lead Instructors to get resources andinformation. Manages FSPCA interactions with FDA International Food Protection Training Institute (IFPTI) Hosts the website for online course enrollment,recordkeeping, and certificates. Manages fees for the FSPCA. Association of Food and Drug Officials (AFDO) Works with Lead Instructors on registering courses.
FSMA RulesRegulationFinal PublicationPreventive Controls (Human Food)Sept 17, 2015Preventive Controls (Animal Food)Sept 17, 2015Produce SafetyNov 27, 2015Foreign Supplier Verification ProgramNov 27, 2015Accredited Third Party CertificationNov 27, 2015Sanitary TransportApril 5, 2016Intentional AdulterationMay 27, 201614
FSMA Rules and FSPCA InvolvementRegulationFinal PublicationPreventive Controls (Human Food)Sept 17, 2015Preventive Controls (Animal Food)Sept 17, 2015Produce SafetyNov 27, 2015Foreign Supplier Verification ProgramNov 27, 2015Accredited Third Party CertificationNov 27, 2015Sanitary TransportApril 5, 2016Intentional AdulterationMay 27, 201615
OrganizationandGovernance16
FSPCA Structure (old)FSPCA Steering CommitteeFederal andState icResearchersand EducatorsContinuationSubcommitteeUS FoodIndustryTradeAssociationRepsAnimal roupsTraining Materials, Course,Models, ProtocolCertificates and RecordsAssociation of Food andDrug Officials and theAssociation of AmericanFeed Control OfficialsInternational FoodProtection TrainingInstitute17
FSPCA Committees, Subcommittees, Work ationSubcommitteeTrainers ofTrainersWork GroupOutreachSubcommitteeWebsiteWork GroupTechnicalAssistanceWork GroupConferenceWork GroupCurriculumSubcommittee(Human Food)Model FoodWork GroupContent WorkGroupModel FoodWork GroupForeign SupplierVerificationProgram (FSVP)SubcommitteeInternationalSubcommitteeAnimal FoodSubcommitteeTraining ContentWork GroupTrainer NetworkWork GroupSpanishLanguageReview TeamMandarinReview TeamFrench LanguageReview TeamJapaneseLanguageReview TeamPortugueseLanguageReview TeamHindiReview TeamTechnicalAssistanceWork GroupIntentionalAdulteration (IA)SubcommitteeContentWork Group18
CurriculumPreventive Controls forHuman Foods19
FSPCA Preventive Controls Course The FSPCA Preventive Controls for Human Food course isthe “standardized curriculum” recognized by FDA Training is one means to become “Preventive ControlsQualified Individual” required by PC Rules Lead Instructors have access to: “Instructor Notes” to assist with delivery and interpretation Exercise guides and instructions to reinforce key learningobjectives Simplified model foods for exercises that are consistent withregulatory requirements Access to all current resources and information that the Allianceprovides20
Standardized Curriculum Goals Facilitate understanding of FDA expectations Provide training leading to “Preventive ControlsQualified Individual” Understanding of “Food Safety Plan”21
Curriculum Support MaterialsFor Students Participants Manual –(Open access) Slide images, supporting text,example forms, Food SafetyPlan example, references Exercise WorkbookFor FSPCA Lead Instructors Instructors Manual Annotated Participant’sManual Slide set Instructor’s Exercise Guide Model foods teachingexamples Adult learning andadministration procedures22
Hazard Analysis and Risk-Based PreventiveControlsFood Safety Plan
Preventive Food Safety SystemsFood Safety PlanIncluding procedures formonitoring, corrective actionand verification, as rgen ControlProgramControlHazardAnalysisRecallPlanGMPs and OtherPrerequisite Programs
Risk-based Preventive Controls Focus on what matters most for food safety Preventive, not reactive Work in conjunction with and supported by otherprograms like Good Manufacturing Practices Designed to minimize the risk of food safety hazards
US SpaceprogramLow-acid cannedfood regsUSDA HACCP regsFDA SeafoodHACCP regsCodex HACCPAnnexFDA Juice HACCPregsNCIMS DairyHACCPImage source: Microsoft clip artOther Risk-based Food Safety Programs
Historically HACCP Focuses on the ProcessHazardAnalysisCriticalControlPoints (CCPs)CriticalLimitsMonitorVerification &RecordkeepingCorrectiveAction
Preventive Controls Include More Than HACCPHazardAnalysisPreventiveControls(CCPs, allergen,sanitation,supplier, etc.)Parameters& ValuesMonitorVerification &RecordkeepingCorrectiveAction orCorrections
What’s New in a Food Safety PlanElementHazard analysisHACCP PlanBiological,chemical, physicalAdded in Food Safety PlanChemical hazards to include radiological;consider econ. motivated adulterationPreventive controls CCPs for processesProcess CCPs controls at other points thatare not CCPsParameters andvaluesCritical limitsParameters and minimum/maximum values( Critical limits for process controls)MonitoringRequired for CCPsRequired as appropriate for preventivecontrolsCorrective actionsor CorrectionsCorrective actionsCorrective actions or corrections, asappropriateVerificationFor processcontrolsAs appropriate for all preventive controls;supplier verification required when suppliercontrols a hazardRecordsFor processcontrolsAs appropriate for all preventive controlsRecall planNot required in the Required when a hazard requiring aplanpreventive control is identified
Implementation30
TimelinePhase I –Organize FSPCAPhase II –Develop CurriculumPhase III –Pilot PhasePhase IV –Implementation201120122013201420152016201731
How are we doing?32
FSPCA Delivery ModelTrainers-ofTrainers (ToTs)train ticipantsmeet trainingrequirements for PCQualified Individual
FSPCA Metrics (Human Foods)* 19,500 Human Foodcourse certificates issued( 3,100 international) 1,300 FSPCA PreventiveControls for Human Foodcourses conducted 270 upcoming coursesscheduled*As of 9/9/1634
Lead Instructors (Human Foods) 877 Lead Instructors 542 Candidates 36 Lead Instructorcourses completed 8 courses currentlyscheduled 103 international Lead Instructors35
FSPCA Metrics (Human Foods)36
FSPCA Metrics (Animal Foods)* 906 Animal Food coursecertificates issued( 18 international) 33 FSPCA PreventiveControls for Animal Foodcourses conducted 32 upcoming coursesscheduled*As of 9/9/1637
Lead Instructors (Animal Foods) 159 Lead Instructors 322 Candidates 3 Lead Instructorcourses completed 0 courses currentlyscheduled*As of 9/9/1638
Instructor and Candidates Distribution – ExampleExample of GeoMap for Lead Instructors and Lead Instructor CandidatesLI Candidates are redLI’s are represented by heat circles39
Technical Assistance40
FSPCA Flyers Domestic International Multiple languages
FSPCA Community Web Community and Technical Assistance Supports Industry, Food Safety Experts , LeadInstructors Project Completed – May 12, 2016 User Acceptance Testing – April 26 Launch – May 11-1344
Community Overview Interactive CommunityTechnical AssistanceResourcesLead Instructor SupportPhase 2 Upgrades – Target Completion – September2016https://fspca.force.com/FSPCA/s/45
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FSPCA Technical Assistance Network –InquiryRouting ProcessInquiryFormInitiated Submissions using the form onthe alliance web page Date and time of submissioncaptured Unique identifier generatedInquiryRoutingto FSE Identify key words for indexing Match data with FSE Notify FSE of Inquiry Date and time of transfer to FSEcapturedInquiryTracking Track unique identifier Verify FSE receiptAnswerVetting Answer returned to network Answer vetted for accuracy andfitResponsetoInquirer Response sent to Inquirer Date and Time captured Inquiry closed Response fields for every question are fullysearchable Usage statistics and demographics areavailable in real time
Technical Assistance NetworkPage to submit a question to the FSPCA Technical Assistance NetworkFrequently Asked Questoins and Topics are on the side48
Outreach TAN Conference / Meeting - 2017Structural ChangesFSPCA , FDA - (FSE’s and SME’s)Technical exchange to Discuss TAN operationShare best practicesGain feedback to datePlan next steps49
FSPCA Webinars2016 Webinars April 21 July 21 October 202017 Webinars January 19 Spring TBD Summer TBD Fall TBDFSPCA Update Webinars*The Food Safety Preventive Controls Alliance (FSPCA),in collaboration with the Food and DrugAdministration (FDA), hosts quarterly webinars toupdate stakeholders on the progress of the Alliance.Update webinars scheduled for April 21, July 21,October 20, 2016 and January 19, 2017.* Go to “Upcoming Events on the FSPCA Website
Coming Soon! Foreign Supplier Verification Training
Coming Soon! Foreign Supplier Verification Training Intentional Adulteration Training
Coming Soon! Foreign Supplier Verification Training Intentional Adulteration Training “Blended Course”
Human Food “Blended Course”Part 1 – Online, self-paced Covers material in Version1.2 Knowledge checks toengage learner Anticipate to go “live” latefall of 2016Part 2 – Lead Instructor led Slide set for review oflearning objectives Exercise Workbook used toreinforce learning usingmodel foods54
THANK YOU!Robert E. Brackett, Ph.D.IIT Vice President and DirectorInstitute for Food Safety and HealthIllinois Institute of Technology55
QuestionsIf you have any questions,please contact the FSPCA atfspca@iit.eduor or visit the FSPCA website athttp://www.iit.edu/ifsh/alliancefor resources on preventive controls, lead instructorapplication, and details of other FSPCA activities.56
the “standardized curriculum” recognized by FDA Training is one means to become “Preventive ontrols Qualified Individual” required by P Rules . HACCP regs FDA Juice HACCP regs USDA HACCP regs Codex HACCP Annex NCIMS Dairy HACCP art. Verification & Recordkeeping Historica
FSMA Human Food Audit Checklist Iowa State University Extension and Outreach Department of Food Science and Human Nutrition . The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA is the largest change in food safety law since the Food, Drug, and Cosmetic Act was first passed in 1938.
signed into law in 2011, focuses on the reduction and prevention of food safety risks, and encompasses the entire food chain. FSMA includes seven major rules, recognizing that food safety is a shared responsibility. The FSMA Produce Safety Rule provides guidance to growers on standards for the safe growing, harvesting,
Safety Modernization Act (FSMA) was signed into law on Jan. 4, 2011 and represents the most sweep-ing reform of the FDA's food safety authority in over 70 years. Among the most significant changes under the FSMA is the shift towards preventing food safety problems rather than reacting to prob-lems after they occur. The FSMA gives the FDA
6/14/15 2 What is the New Law? ! Food Safety Modernization Act (FSMA) ! Effective Jan 4, 2011 ! Bi
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developed Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs (2013) in response to the 2011 FDA Food Safety Modernization Act (FSMA). The purpose of the FSMA is to shift the focus from response toward prevention.
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Application of Silicon Carbide in Abrasive Water Jet Machining Ahsan Ali Khan and Mohammad Yeakub Ali International Islamic University Malaysia Malaysia 1. Introduction Silicon carbide (SiC) is a compound consisting of silicon and carbon. It is also known as carborundum. SiC is used as an abrasive ma terial after it was mass produced in 1893. The credit of mass production of SiC goes to Ed .
