Presentation on theme: "LGMA California Leafy Green Marketing Agreement"— Presentation transcript:
1LGMA California Leafy Green Marketing Agreement The State of Food Safety“FSMA and Beyond”Mike VillanevaAssistant County Agricultural Commissioners ConferenceRedding, CAOctober 4-5, 2012
2Introduction History and how did we get here? What does it mean for all of us?What are the challenges and expectations?What has FDA learned from the LGMA modelHow does the LGMA structure, organization and requirements compare to FSMA?What’s next?
3Food Safety Modernization Act FSMA Overview:Major “overhaul” of FDA Food Drug and Cosmetic ActBroad expansion of FDA authorityClear and specific oversight of fresh produceRegulatory oversight and verificationCooperation between other state and federal agencies
4Standards for Produce Safety Key Considerations:History of outbreaks and severityProcedures, practices and processesMicrobial, physical and chemical adulterationScience-based minimum standardsEnvironmental and conservation practicesExemptionsCoordination of education and enforcement
5Standards for Produce Safety Other Considerations:Set forth procedures, processes and practices known to be reasonably necessary to prevent the introduction of know or reasonably foreseeable biological, chemical or physical hazards, including hazards that occur naturally or that may be unintentionally introduced.
6Potential Regulations General Operations:GrowingHarvestingSortingPackingStorageTransportation
7Potential Regulations Specific Categories:Soil amendmentsHygienePackagingTemperature controlsAnimals in growing areaWater
8Exemptions for Direct Marketing Qualifications:Average sales of food to “qualified end-users” was > that sold to all other buyersTotal average sales of food was < $500,000End-usersConsumer of the food or a:Restaurant or food establishment located in the same state as farm or < 275 miles from farm
9Enhanced Tracking and Tracing Additional Requirements for high risk foods:Relate only to information readily available and appropriateBe science basedNot prescribe specific technologies for maintenance of recordsBe scaleable and practical
10Training for Regulatory Officials Training and Education Programs:ScienceConducting inspectionsAdvanced product or process specializationBest practicesAdministrative processes and proceduresSampling and laboratory analysis methods
11Training for Industry Training, Education and Technical Assistance: Owners and operators of farmsSmall food processorsSmall fruit and vegetable merchant wholesalersOthers?Process has begun via the Produce Safety Alliance
12LGMA GAP Audit ProgramProgram Structure: Operating with oversight from the California Department of Food and Agriculture, the LGMA is a mechanism for verifying through mandatory government audits that growers follow accepted food safety practices for lettuce, spinach and other leafy green products.
13LGMA GAP Audit Program Key Components: Industry and government collaborationBest practices and sound scienceRegular and unannounced field auditsPenalties and results for non-complianceProgressive training and education programAdaptable and scalable system
14Metrics Accepted Food Safety Practices: Based upon best practices and sound scienceCommodity specific on individual farmsRecognized food safety principles of risk assessment and mitigation stepsReviewed by state and federal health agenciesRevised as research findings evolve
15LGMA GAP Audit Program “Program Components” AuditorsAuditChecklistComplianceCertification
16LGMA GAP Audit Program Key Performance Provisions: Handler and grower responsibilitiesMultiple audits during seasonMandatory unannounced auditsAuditor observations during auditLGMA Compliance Officer assigns violationsCorrective actions must be submittedSpecific provisions of USDA auditors
17Auditors Experience and Characteristics: Auditors are CDFA employees Trained and licensed by USDADedicated auditors for leafy green industryHave extensive audit training and experienceOnly note observations made during auditOperate under USDA and CDFA provisions
18Audit Checklist Categories General RequirementsWaterSoil AmendmentsRisk AssessmentsWorker PracticesField Sanitation
24CertificationGranted after a successful audit and completing corrective actionsMaintained through scheduled and unannounced government auditsMembers in good standing may use the LGMA service mark on bills of ladingDecertification if flagrant violation(s) of the marketing agreement occur
25Penalties and Compliance LGMA has issued more than 3000 citations for non-compliance since 2007No unsafe product reached consumersMajority involved missing paperwork and documentationImmediate corrective actions requiredHigh compliance rateMajor consequences for non-compliance
26Other Concerns Pathogen testing of raw product Multiple audits Individual buyer auditsMDP and FDA surveillance programsInfluence of international audit and certification bodiesGFSIGlobal GAP
27Summary Much interest in the FSMA regulations Will have an impact on the produce industryExpect some “minimum level” of metricsFDA will need to “partner” with other regulatory agenciesIrrigation waterSoil amendmentsTraining and education will be critical