The Food Safety Modernization Act And The Food Safety .

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The Food Safety Modernization Act and the Food SafetyPreventive Controls AllianceRobert E. Brackett, Ph.D.Illinois Institute of Technology

Background:The U.S. Food Safety System

Agencies involved in Food Safety U.S. Food and Drug Administration (FDA)USDA/Food Safety and Inspection Service (FSIS)Environmental Protection Agency (EPA)National Oceanic and Atmospheric Agency (NOAA) National Marine Fisheries Service Center for Disease Control and Prevention (CDC) States State food safety agencies “Cooperative Programs” with FDA (e.g. Interstate ShellfishSanitation Program)

Food Safety in the U.S. Two Main Federal Food Safety Regulatory Agencies USDA/FSISoCattle, Sheep, Goats, Horses, Mules, Egg products,catfish FDAoAll foods NOT covered by USDA– Dairy, Produce, Bakery, Dietary Supplements, Seafood,Ingredients, Game Meats Environmental Protection AgencyoSanitizers

Food Groups Under FDA Authority Dairy Products Milk Cheese Butter Plant products VegetablesFruitsNutsJuices Spices Dietary Supplements Seafood FinfishShellfishCrustaceansSurimi based Grain-based Bread Cereals Flour Bottled water Cosmetics

Food Safety in the U.S. Two Main Federal Food Safety Regulatory Agencies Why Does it Matter? Statutory authorityo Continuous Inspection (USDA) vs. Periodic (FDA)o On-farm authority (FDA)

Food Safety in the U.S. Two Main Federal Food Safety Regulatory Agencies Why Does it Matter? Statutory authorityo Continuous Inspection (USDA) vs. Periodic (FDA)o On-farm authority (FDA) Inspectional capacityo USDA - 7800 inspectors for 6800 facilitieso FDA – 2000 inspectors for 130,000 facilities

Food Safety in the U.S. Two Main Federal Food Safety Regulatory Agencies Why Does it Matter? Statutory authorityo Continuous Inspection (USDA) vs. Periodic (FDA)o On-farm authority (FDA) Inspectional capacity Analytical Methodologyo USDA - similar food matrices– Efficient throughputo FDA - very diverse matrices– Laboratories also responsible for non-food products

Why?

Statutory Authority The Federal Food and Drugs Act of 1906The Federal Meat Inspection Act of 1906The Federal Import Milk Act (1927)The Federal Food, Drug, and Cosmetic Act of 1938, asamended The Public Health Service Act (1944) The Poultry Products Inspection Act of 1957 The Fair Packaging and Labeling Act (1966)

Statutory Authority The Infant Formula Act of 1980, as amended The Nutrition Labeling and Education Act of 1990 The Dietary Supplement Health and Education Act of1994 The Bioterrorism Act of 2002 Food Allergen Labeling and Consumer Protection Actof 2004 FDA Food Safety Modernization Act of 2011

THE PREVENTIVE CONTROLS RULES AND THE FOODSAFETY PREVENTIVE CONTROLS ALLIANCE

Food Safety Modernization Act“.the most sweeping reform of ourfood safety laws in more than 70 years.”- FDA13

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

FSMA RulesRegulationProposalFinal (consent decree)Preventive Controls(Human Food)January 16, 2013August 30, 2015*Preventive Controls(Animal Food)October 29, 2013August 30, 2015*Produce Safety**January 16, 2013October 31, 2015Foreign SupplierVerification Program**July 29, 2013October 31, 2015Third Party AccreditationJuly 29, 2013October 31, 2015Sanitary TransportFebruary 5, 2014March 31, 2016Intentional AdulterationDecember 24, 2013May 31, 2016*Final submitted on August 31, 2015, made public on September 10, 2015**Supplemental proposals published September 201415

Final RuleSept 16, 2015*Effective Sept 16, 20152015Very Small FirmSmall FirmLarge FirmCompliance Date Compliance Date Compliance DateSept 16, 2016Sept 16, 2017 Sept 16, 2018201620172018Preventive Controls Human and Animal FoodRegulations Implementation Timeline

FSMA RulesRegulationProposalFinal (consent decree)Preventive Controls(Human Food)January 16, 2013August 30, 2015*Preventive Controls(Animal Food)October 29, 2013August 30, 2015*Produce Safety**January 16, 2013October 31, 2015Foreign SupplierVerification Program**July 29, 2013October 31, 2015Third Party AccreditationJuly 29, 2013October 31, 2015Sanitary TransportFebruary 5, 2014March 31, 2016Intentional AdulterationDecember 24, 2013May 31, 2016*Final submitted on August 31, 2015, made public on September 10, 2015**Supplemental proposals published September 201417

Preventive Controls for Human Foods Part 117 Current Good Manufacturing Practice,Hazard Analysis, and Risk-based PreventiveControls for Human Food Subpart A--General ProvisionsSubpart B--Current Good Manufacturing PracticeSubpart C--Hazard Analysis and Risk-Based Preventive ControlsSubpart D--Modified RequirementsSubpart E--Withdrawal of a Qualified Facility ExemptionSubpart F--Requirements Applying to Records That Must BeEstablished and Maintained Subpart G--Supply-Chain Program

Preventive Controls for Human Foods Part 117 Current Good Manufacturing Practice,Hazard Analysis, and Risk-based Preventive Controlsfor Human Food Subpart A--General Provisions Subpart B--Current Good Manufacturing Practice Subpart C--Hazard Analysis and Risk-Based Preventive Controls Subpart D--Modified Requirements Subpart E--Withdrawal of a Qualified Facility Exemption Subpart F--Requirements Applying to Records That Must Be Establishedand Maintained Subpart G--Supply-Chain Program

Hazard Analysis and Risk-Based PreventiveControlsFood Safety Plan

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysis; Preventive controls;o Monitoring;o Corrective actions and corrections;o Verification; Supply-chain program; Recall plan; and Associated records.

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysiso Identify and evaluate reasonably foreseeable hazards– Source» Experience» Illness data» Scientific reports» Other

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysiso Identify and evaluate reasonably foreseeable hazards– Source– Type» Biological hazards, including microbiological hazards such asparasites, environmental pathogens, and other pathogens;» Chemical hazards, including radiological hazards, substancessuch as pesticide and drug residues, natural toxins,decomposition, unapproved food or color additives, andfood allergens; and» Physical hazards

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysiso Identify and evaluate reasonably foreseeable hazards– Source– Type– Food Matrix» Formulation» Source of ingredients» Storage and transportation» Etc.

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysis Preventive Controlso MUST be writteno Process controlso Food allergen controlso Sanitation controlso Supply-chain controlso Other controls (eg. hygiene training)o Verification and validation, monitoring, corrective actions

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysis Preventive Controls Supply-chain program*o MUST be writteno Using approved supplierso Appropriate supplier verification activities– Onsight audits– Sampling and testing– Review of Suppliers records*Described in Part 117 Subpart G

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysis Preventive Controls Supply-chain programo MUST be writteno Using approved supplierso Appropriate supplier verification activitieso Documenting supplier verification

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysisPreventive ControlsSupply-chain programRecall Plano MUST be writteno Procedureso Notifications (consignees and public)o Effectiveness checkso Disposal procedures

Hazard Analysis and Risk-Based PreventiveControls A written food safety plan; Hazard analysisPreventive ControlsSupply-chain programRecall PlanAssociated recordso Rationale for NOT using preventive controlso Monitoringo Corrective actionso Validation, verification, calibration, etc.o Product testing

Why the Food SafetyPreventive ControlsAlliance?30

Introduction Background FDA recognized the need to assist theregulated industry to comply with FSMA Decision was made to follow the SeafoodHACCP Alliance model FSPCA followed similar format, but withdifferent structure to account to variouscommodities included in FSMA31

FSPCA - Public-Private Partnership32

OrganizationandGovernance33

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 Group34

CurriculumPreventive Controls forHuman Foods35

Benefits of FSPCA Preventive Controls Course The FSPCA Preventive Controls for Human Food course isthe “standardized curriculum” recognized by FDA Training will be one means to become “PreventiveControls Qualified 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 Allianceprovides36

Standardized Curriculum Goals Facilitate understanding of FDA expectations Provide training leading to “Preventive ControlsQualified Individual” Understanding of “Food Safety Plan”37

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 Enhance HACCPHazardAnalysisPreventiveControls(CCPs & others)Parameters& ValuesMonitorVerification &RecordkeepingCorrections/ CorrectiveAction

Preventive Food Safety SystemsFood Safety PlanIncluding procedures formonitoring, corrective actionand verification, as rgen ControlProgramControlHazardAnalysisRecallPlanGMPs and OtherPrerequisite Programs

Food Safety Plan vs. HACCP PlanFood Safety PlanHACCP PlanHazard analysisHazard analysisPreventive controls (PCs)CCPs to control food hazardsProcess controls*Critical limitsMonitoring**MonitoringCorrective actions**Corrective ocess controls have, as appropriate, parameters and min./max. values**As appropriate to ensure the effectiveness of the PCs, taking intoaccount the nature of the PC

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

FSPCA Delivery ModelTrainers-ofTrainers(ToTs)train ticipantsmeet trainingrequirements for PCQualified Individual

Curriculum Support MaterialsFor StudentsFor FSPCA Lead Instructors Participants Manual –(Open access) Instructors Manual Slide images, supporting text,example forms, Food SafetyPlan example, references Exercise Workbook Annotated Participant’sManual Slide set Instructor’s Exercise Guide Model foods teachingexamples Adult learning andadministration procedures46

OUTREACHwww.iit.edu/ifsh/fspca47

48

FSPCA Flyers Domestic International Multiple languages

50

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 11-1351

Community Overview Interactive CommunityTechnical AssistanceResourcesLead Instructor SupportPhase 2 Upgrades – September 2016https://fspca.force.com/FSPCA/s/52

53

Outcomes Training Metrics Research Needs and Questions Validation of both existing and new technologies Evaluation of training and messaging54

FSPCA MetricsFSPCA Preventive Controls Certificates IssuedHuman FoodAnimal 0942,174As of February 10, 201755

FSPCA Metrics28,738As of February 10, 201756

FSPCA Preventive Controls CoursesAnimal FoodHuman FoodTotal Courses Registered1352,400Courses Completed702,025International Courses ConductedBlue CoursesRed Lead InstructorsAs of February 10, 201757

58

Lead InstructorsHuman Food LIs1,095Animal Food LIs196Human Food Candidates572Animal Food Candidates336Human Food LI Courses Completed40Animal Food LI Courses Completed3In 2017, see the FSPCA website for upcoming LI coursesAs of February 10, 201759

FSPCA International Action PlanFSPCACommunityiTAN Network of International Food Safety Experts Answer technical questions from industry Develop Q&As, knowledge articles, food models, and outreach materialsLeadInstructors Worldwide training resources available to provide FSPCA training courses Building capacity of “in country” Lead Instructors and Trainer of Trainers Increase number of FSPCA PCQI courses worldwideIndustry60 Interactive web community and technical assistance Supports industry, Lead Instructors, Food Safety Experts Accessible via https://fspca.force.com/FSPCA/s/ Receive training Access FSPCA Community Ask technical questions

Technical Assistance61

FSPCA Website: https://www.ifsh.iit.edu/fspca

FSPCA Flyers Domestic International Multiple languages

FSPCA Community

FSPCA Preventive Controls for Human FoodLead Instructor Training – Milan, ItalyDate: March 21-23, 2017Time : 9:00 AM – 6:00 PMLocation: Hotel Des Etrangers *** Space Supranational Hotels Via Sirte, 9 – 20146 Prerequisites:1.Successful completion of the FSPCA Preventive Controls for Human Food Course2.Must be an approved FSPCA Lead Instructor candidate to registerInformation on how to apply to become a Lead Instructor can be found at fspca.net Course Description: This 2.5-day course provides the participant the knowledge andtools needed to perform the duties of a Lead Instructor for the standardized trainingcurriculum that FDA considers adequate in meeting the requirements for training of a“Preventive Controls Qualified individual” under FDA’s Preventive Controls for HumanFood rule. ontrols-human-food#LICS)

Why the Institute forFood Safety and Health?67

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 CollaborationSmuckers70

Department of Food Science and Nutrition (FdSN)Current enrollment 137 studentsThesis Degrees Master of Science in Food Safetyand TechnologyMaster of Science in Food Process EngineeringPh.D. in Food Science and NutritionNon-Thesis Degrees Master of Food Safety and TechnologyMaster of Food Safety and Technology withSpecialization in Business Master of Food Safety and Technology withSpecialization in Industrial Technology Management Master of Food Process EngineeringCertificate Food Safety and TechnologyFood Safety and Industrial ManagementFood Process EngineeringFood Processing Specialist

THANK YOU!Robert E. Brackett, Ph.D.IIT Vice President and DirectorInstitute for Food Safety and HealthIllinois Institute of Technology72

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.73

Curriculum Subcommittee (Human Food) Model Food Work Group Animal Food Subcommittee Content Work . the “standardized curriculum” recognized by FDA Training will be one means to become “Preventive . HACCP regs FDA Juice HACCP regs USDA HACCP regs Codex HACCP Annex NCIMS Da

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