LGMA California Leafy Green Marketing Agreement

The State of Food Safety“FSMA and Beyond”

Mike VillanevaAssistant County Agricultural Commissioners

ConferenceRedding, CA

October 4-5, 2012

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

General Operations:• Growing• Harvesting• Sorting• Packing• Storage• Transportation

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

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

THANK YOU!

Mike VillanevaLGMA

(916) 441-1240mike@lgma.ca.gov