Presentation on theme: "Introduction 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."— Presentation transcript:
Introduction 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 model How does the LGMA structure, organization and requirements compare to FSMA? What’s next?
Food Safety Modernization Act FSMA Overview: Major “overhaul” of FDA Food Drug and Cosmetic Act Broad expansion of FDA authority Clear and specific oversight of fresh produce Regulatory oversight and verification Cooperation between other state and federal agencies
Standards for Produce Safety Key Considerations: History of outbreaks and severity Procedures, practices and processes Microbial, physical and chemical adulteration Science-based minimum standards Environmental and conservation practices Exemptions Coordination of education and enforcement
Standards 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.
Potential Regulations Specific Categories: Soil amendments Hygiene Packaging Temperature controls Animals in growing area Water
Exemptions for Direct Marketing Qualifications: Average sales of food to “qualified end-users” was > that sold to all other buyers Total average sales of food was < $500,000 End-users Consumer of the food or a: Restaurant or food establishment located in the same state as farm or < 275 miles from farm
Enhanced Tracking and Tracing Additional Requirements for high risk foods: Relate only to information readily available and appropriate Be science based Not prescribe specific technologies for maintenance of records Be scaleable and practical
Training for Regulatory Officials Training and Education Programs: Science Conducting inspections Advanced product or process specialization Best practices Administrative processes and procedures Sampling and laboratory analysis methods
Training for Industry Training, Education and Technical Assistance: Owners and operators of farms Small food processors Small fruit and vegetable merchant wholesalers Others? Process has begun via the Produce Safety Alliance
LGMA GAP Audit Program Program 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.
LGMA GAP Audit Program Key Components: Industry and government collaboration Best practices and sound science Regular and unannounced field audits Penalties and results for non-compliance Progressive training and education program Adaptable and scalable system
Metrics Accepted Food Safety Practices: Based upon best practices and sound science Commodity specific on individual farms Recognized food safety principles of risk assessment and mitigation steps Reviewed by state and federal health agencies Revised as research findings evolve
LGMA GAP Audit Program “Program Components” GAP Audit Auditors Audit Checklist Compliance Certification
LGMA GAP Audit Program Key Performance Provisions: Handler and grower responsibilities Multiple audits during season Mandatory unannounced audits Auditor observations during audit LGMA Compliance Officer assigns violations Corrective actions must be submitted Specific provisions of USDA auditors
Auditors Experience and Characteristics: Auditors are CDFA employees Trained and licensed by USDA Dedicated auditors for leafy green industry Have extensive audit training and experience Only note observations made during audit Operate under USDA and CDFA provisions
Audit Checklist Categories General Requirements Water Soil Amendments Risk Assessments Worker Practices Field Sanitation
Certification Granted after a successful audit and completing corrective actions Maintained through scheduled and unannounced government audits Members in good standing may use the LGMA service mark on bills of lading Decertification if flagrant violation(s) of the marketing agreement occur
Penalties and Compliance LGMA has issued more than 3000 citations for non-compliance since 2007 No unsafe product reached consumers Majority involved missing paperwork and documentation Immediate corrective actions required High compliance rate Major consequences for non-compliance
Other Concerns Pathogen testing of raw product Multiple audits Individual buyer audits MDP and FDA surveillance programs Influence of international audit and certification bodies GFSI Global GAP
Summary Much interest in the FSMA regulations Will have an impact on the produce industry Expect some “minimum level” of metrics FDA will need to “partner” with other regulatory agencies Irrigation water Soil amendments Training and education will be critical