Thomas Vogel – Director, Food Safety DFA of California Jeremiah Szabo – Director of Operations, DFA of California

1. The Red Seal – Your Road to FSMA and Quality Compliance Thomas Vogel – Director, Food Safety DFA of CaliforniaJeremiah Szabo – Director of Operations, DFA of California

2. OurPresentersToday – Thomas Vogel •Auditor, Trainer, Consultant–DFA of California •Drivingforcebehindourfoodsafetyoperationsintheareasof GoodManufacturingPractice(GMP),GoodAgriculturalPractice (GAP) andsupplierassuranceprograms,includingHACCP, SQFandBRC •35yearsofexperienceinthefoodindustry,whileworkingfornationaland internationalcompaniesinqualityassurance,productdevelopmentand auditing. •BSCinChemistryandanaccomplishedfoodsafetytrainer for numerousfoodsafetymanagercertificationcourses •Inaddition,heisaGMP/HACCPinstructor,aLeadAuditortrainer,andisalso certifiedto audit ontheGlobalFoodSafetyInitiativefor SQF and BRC. Heiscertifiedin numerousproductcategories

3. OurPresentersToday – Jeremiah Szabo •Operations Director for commodity inspection and laboratory programs, Auditor, Trainer, Consultant – DFA of California •10 years of food industry experience working in Quality Control, Quality Assurance, Laboratory management, and food safety. •BSC in Biological sciences, certified HACCP auditor, certified to audit to Global Food Safety Initiative (GFSI) audits for BRC and SQF audits, GMP/HACCP/Internal Auditor trainer,

4. Purpose Of This Session • Overview of Food Safety Modernization Act • Provide an update on the implementation of FSMA • How the Red Seal can assist with FSMA compliance • How the Red Seal can give a market advantage • Q&A

5. FoodSafetyModernizationAct(FSMA) CongresspassedFSMAonDecember20th2010 PresidentObamasigneditintolawonJanuary4th,2011 Congresssetsthelaws,FDAdevelopstheregulationstofitwiththe lawsandthenenforcesthelaws. Initialtimetablehada3yearimplementationplanwithpartsbeing implementedimmediatelyandotherpartsgraduallybutFDAhasnot beenabletomeetthistimeframeanditisnowlikelytobea5-7year plan.

6. FoodSafetyModernizationAct(FSMA) FederalJudgefromtheUSDistrictCourtinNorthernCaliforniahas ruledthatFDAhastomeetthefollowingtimetable. RegulationsallhadtobepublishedbyNovember30th,2013. AllcommentperiodshavetobeclosedoutbyMarch31st,2014. FinalregulationsneedtobeputintoeffectbyJune30th,2015. Followedbya3yearimplementationplanforIndustry.

7. FoodSafetyModernizationAct2010 Title1Designedtoimprovecapacityto preventfoodsafety problems Title 2 Designedtoimprovecapacitytodetect andrespond tofoodsafetyproblems Title 3 Designedtoimprovethesafetyof importedfood Title 4Includesmiscellaneousprovisions

8. FoodSafetyModernizationAct2010 • ExemptedBusinesses • FSMAdoesnotapplytofacilitiesregulatedbyUSDA (meat,poultryandeggs) • Alsoexemptedarethefollowingindustriesfromany changes: • Juicemanufacturers • Seafoodprocessors • Alcohol-relatedfacilities • Lowacidcanning(excepttoexpandtheirHazard Analysis) • SmallBusinesses<$500,000salesand 50%oftheirsaleswithin 275milesof theirfacility(Testeramendment) • FDAisconsideringmodifiedrequirementsfor warehousesandhavingPreventiveControls onlyiftheyarestoringrefrigeratedproducts.

9. Title 1 SectionsDesigned to prevent food safety problems • Section 101 FDAaccesstoyourrecords • Section 102 RegistrationandpossiblesuspensionbyFDA • Section 103 PreventiveControls(HACCP) • Section 104 FDAhazardinformation • Section 105 Producefoodsafetyguidelines • Section 106 Regulationstopreventintentionaladulteration • Section 107 FeeassessmentsbyFDA • Section 108 Nationalagricultureandfooddefensestrategy

10. Title1Sections Continued • Section 109 AnnualreportingbySecretaryofHomeland Security • Section 110 Buildingdomesticcapacity • Section 111 Sanitarytransportationregulations • Section 112 Allergeneducation • Section 113 Newdietaryingredients

11. SectionsUpdate Weareforthepurposeofthisupdateconfiningourupdates tothe followingSectionsofFSMA: Section 103 Preventive Controls Rule proposal. Section105ProduceGuidelines. Section106IntentionalAdulterationofFoods. Section301VoluntaryImporterProgram. Section306RiskAssessmentonImportedFoods. Section307ThirdPartyAccreditedAudits.

12. Section103 cGMPandHazardAnalysisandRisk-BasedPreventiveControlsfor Humanfood. • Requiresregisteredfacilitiesunlessexempt,to: • Haveawrittenfoodsafetyplan • PerformaHazardanalysis • Implementriskbasedpreventivecontrolmeasures • ConductMonitoring • PerformCorrectiveActions • Verifytheeffectivenessofthesepreventivecontrols • Maintainrecords(FDAtoprovidelistofwhat recordswillberequired).

13. Section103 • cGMPandHazardAnalysisandRisk-BasedPreventiveControlsfor Humanfood. • RequiresallFDAregisteredfacilitiestocomply withtheexceptionof DietarySupplementmanufacturers • Seafoodcompanies. • Juicemanufacturers. • Alcoholmanufacturers. • Lowacidcanning. • Proposingtopossiblyexempt • grinding,milling,orcrushingofgrains. • In-farmpackingofintactfruitandvegetables. • Facilitiesstoringunexposedproducts.

14. PREVENTIVECONTROLS • "PreventiveControls"vs.HACCP • CCPsvs.CPs. • Knowingyourrisks • ManagingyourRisks • Training

15. PREVENTIVECONTROLSvs.HACCP FDAmakesapointinthisproposedrulethatalthoughPreventiveControls shouldbedeterminedusingPrinciple1(HazardAnalysis)asindevelopinga HACCPprogramthePreventiveControlsshouldnotbelimitedtojustCCPs. • Needtoinclude • Pre-requisiteprograms • Recallprogram • Sanitationprograms • EnvironmentalPathogensandcontrols • Allergensandcontrols • EquipmentCalibration • FoodDefenseProgramseeSection106.

16. PREVENTIVECONTROLSvs.HACCP FDA'ssupportinformationforrequiringcompaniestodevelopand implementPreventiveControlsprogramsvs.HACCPplansstates thatcompanieswithHACCPplanshavenotputtheduediligence intoimplementingandmonitoringtheirCPs. ThoughtsareherethatindustryhasdeferredtoaCPinsteadofa CCPsoastoavoidhavingtomonitor,recordandreacttopossible variancesrequiredofaCCPinaHACCPPlanandthishasthus continuedtocausecontaminatedproductstobedistributedand hencecausesubsequentRecalls. IndustryhasalsodeferredtotheirSupplierscontrolofcertain possiblehazardstotheextentthattheytrusttheirSuppliersbut neververifytheirSupplierscananddoachievethislevelofcontrolof an"likelytooccur"hazard.

17. Section103 • cGMPandHazardAnalysisandRisk-basedPreventive • ControlsforHumanfood. Thisproposedrulerequiresalso: •Thatlowacidcanningfacilitiesexpand theirhazardanalysistoincludechemical andphysicalhazards •Requiresthateachhazardanalysisto includethepossibilityofdeliberateor "terroristic"contaminationofyourproducts. (Howeverpreventivecontrolsforthisareto becoveredunderyourFoodDefenseplan (SeeSection106)notthisplan). •Requiresallcompaniestoreanalyzetheir potentialhazardseverythreeyears

18. Section103 cGMPandHazardAnalysisandRisk-basedPreventive ControlsforHumanfood. FSMAaskscompaniestoassess chemical,radiologicalhazards,natural toxins,pesticides,drugresiduesintheir hazardanalysis,(arsenicin chicken, aflatoxinsin figs,oracrylamide in corn chips). (FDArecentlyloweredtheallowable arseniclevelinapplejuicetomatchthat allowedindrinkingwater).

19. cGMPWorkingGrouppresentedtotheFDA7 areasofopportunityforupdatingthecGMPs. • Training • Documented Allergen controls • Documented environmental pathogen control program • Documented SSOPs • Maintenance of food safety records • Possibly removing the exemption given to companies who just handle raw agricultural products • Getting public comment for time and temperature as related to the safe storage of hot and cold foods

20. Red Seal Certification Program

21. Certification Program Requirements • Red Seal Certificate • Available to DFA of California and Specialty Crop Trade Council members only! • DFA Red Seal Member companies must meet… • Facility Requirements • Quality Requirements

22. No other Product Certification in the industry gives the customer…. • Facility Food Safety Certification • Customer specific Product Quality Certification • Customer specific Product Laboratory Certification

23. Red Seal Certified Commodities Tree Nuts…… Dried Fruit……

24. Food Safety Certification • Red Seal Member facilities must…. • Demonstrate that their products are handled, produced, packaged and stored at a facility operating according to… • Codex Alimentarius (HACCP) and the National Advisory Committee on Microbiological Criteria of Foods (NACMCF) guidelines • Certified to a Global Food Safety Initiative (GFSI) standard • Verified by an authorized DFA food safety auditor

25. Food Safety Certification DFA Red Seal Members

26. Food Safety Certification

27. Customer Satisfaction is #1! • Quality provisions for Red Seal Certified products:  • Lot averaging not allowed! • Positive lot identification • Inspection within 30 days of shipment • No arbitration on quality • No Rejected segments • Grading to meet customer specifications • Crop year certified • Certify “Contract Requirements” (i.e. Laboratory testing) Product Quality Certification

28. Comparison between FSMA and The Red Seal requirements • Written  Food  Safety  Plan • Both FDA and DFA require that the facility has a written food safety plan. • Both FDA and DFA require that staff be trained and an experienced individual is responsible for developing the program • Prerequisite programs: • DFA emphasizes the importance of prerequisite programs. While FDA does not specifically address PRP’s, in this way DFA is stronger. • Allergen Management • Stronger than what FSMA requires • Food Defense • FDA did not include anything with regard to Food Defense but DFA requires it.

29. Comparison between FSMA and The Red Seal requirements • Validation • Both FDA and DFA require validation of the HACCP plan. • Corrective Action • DFA is stronger than FSMA • Traceability • Both FDA and DFA require a traceability program • Recall Program • Both FDA and DFA require a recall program. • Internal Audits • FDA does not require internal audits, DFA is stronger. • Supplier Verification • Stronger DFA emphasis than FDA

30. Product Quality Certification • Safer Products • Consistent Uniformity • Superior Quality • Ship Red Seal Certified! • redseal@agfoodsafety.org • agfoodsafety.org/quality-inspection/red-seal-certificate

31. Auditing,Certification,Training&Improvement Solutions • BRCFoodSafety • SQF • HACCP • Training • In House • Public Courses • Consultation

32. FoodSafetyServices • Training Public and onsite training(SQF,BRC, HACCP, Advanced HACCP, InternalAuditor,FoodDefense, GMP) • Consulting On-siteGAPanalysis HACCPprogramfacilitation Programreview&development Allergenprogramreviewandvalidation Productspecificationbuilding • Audits Non-Accredited:GMP,Warehouse, HACCP Verification Accredited:GFSIbenchmarkedcertificationaudits (DFA Global Certifications, LLC)

33. THANKYOUFORATTENDING v Q&A