FSMA Implementation Jennifer Thomas Interim Director for FSMA Operations Center for Food Safety and Applied Nutrition Food and Drug Administration National Conference of International Milk Shippers May 13, 2017

FSMA Implementation “A Continuum” Phase 1: Set Standards Develop regulations, guidance, policy Phase 2: Design Strategies to Promote/Oversee Industry Compliance Identify performance metrics to measure success Phase 3: Implement, Monitor, Evaluate, Refresh Transition strategies and performance metrics from design to operational, then evaluate success www.fda.gov

Phase 1: Standard Setting Regulation Final Rule Published Preventive Controls (Human Food) Sept 17, 2015 Preventive Controls (Animal Food) Produce Safety Nov 27, 2015 Foreign Supplier Verification Program Third Party Accreditation Sanitary Transportation April 5, 2016 Intentional Adulteration May 27, 2016

Key Guidance Documents Preventive Controls Human Food Hazard Analysis and Preventive Controls: Draft Published 8/16 Listeria in RTE Food: Draft Published 1/17 Classification of Activities for Farms and Facilities: Draft published 8/16 Small Entity Compliance Guide: Published 10/16 Planned: Hazard Analysis – add’l chapters; Food Allergens, Classification of RTE and non-RTE

Key Guidance Documents Preventive Controls Animal Food CGMP: Draft published 8/16 Human Food By-Products for Use as Animal Food: Draft published 8/16 Small Entity Compliance Guide: Published 10/16 Planned: Hazard Analysis and Preventive Controls

Key Guidance Documents Sanitary Transportation Waivers issued: April 2017 Planned: Compliance Guide, Small Entity Compliance Guide FSVP Unique Facility Identifier: Published 5/10/2017

Phase 2: Promoting Compliance Established an internal Phase 2 structure to operationalize each new rule: Rules/Programs Workgroups (Preventive Controls, Produce, Import Controls, Intentional Adulteration) Cross Cutting Workgroups (e.g., IT, Metrics, Training) .

Phase 2 Charge to Workgroups Develop a framework and multi-year implementation plan for ensuring compliance with regulations: Education, outreach and technical assistance for industry Training/technical assistance for regulators Data collection, analysis, updated IT Performance goals and metrics Inspections, compliance and enforcement

Industry Education, Outreach, Technical Assistance Key Implementation Principle: Facilitate industry compliance with prevention-oriented standards through guidance; developing tools/resources for education, outreach and technical assistance Website Guidance Documents Alliances Technical Assistance Networks

Industry Training - Alliances Produce Safety Alliance (PSA) Cornell University Developed a curriculum to train the farming community Sprout Safety Alliance (SSA) Illinois Institute of Technology Developed a curriculum to train sprout growers Food Safety Preventive Controls Alliance (FSPCA) Developed curricula related to human food, animal food, FSVP; IA in progress

Technical Assistance Network Goal: to provides central, consistent sources of outreach and technical assistance for industry and regulators Two phases: Phase I: FSMA Rule Interpretation Questions Phase II: Food Safety Regulatory Community

Technical Assistance Network Leverage existing internal infrastructure, business processes and IT systems (Knowledge Management System - KMS) Collaborate with external technical resources, e.g., extension specialists, universities, alliances

TAN Number of Inquiries

Technical Assistance Network FDA At-a-Glance - “How to Submit a Question” Submit inquiries via the web form or by mail To submit a question, visit www.fda.gov/fsma and go to Contact Us Common TAN questions posted

Technical Assistance/Training for Regulators Key Implementation Principle: Invest in regulator training/continuing education, on-going calibration of regulators to promote consistent inspections and decision making FSMA Rule Readiness: Industry Best Practices Alliance Courses with Industry Regulator Specific Training Technical Assistance Network / Resources

Inspections Key Implementation Principles Gain industry compliance, reduce the risk of foodborne illness Not a “one size fits all approach” Systems-based inspections, not observation focused Interactive inspections

Compliance/Enforcement Key Implementation Principles: Develop and implement inspection / enforcement strategies that facilitate consistent decision making by regulators Encourage industry to comply and make corrections on its own Recognition that not all observations are equal relative to risk and potential for public health impact Regulatory strategy that is dynamic

Accountability / Stakeholder Engagement Key Implementation Principles: Develop meaningful public health/performance metrics to measure success Recognize the role of the marketplace in influencing and expanding industry compliance with FSMA rules Work closely with industry, government agencies, academia, and other key stakeholders/partners

Preventive Controls for Human Food Rule www.fda.gov

Preventive Controls Human Food Compliance Dates*

Regulator Training Main elements FSPCA Alliance training FSMA Rule Readiness CGMP web-based course PC Inspection Regulator Course

Inspections - Modernized GMPs Includes all foods that are subject to the cGMPs Assess compliance with cGMP requirements Includes an overarching assessment of preventive control programs Includes domestic and foreign

Inspections – Modernized GMP and Preventive Controls Sanitation Control Program Avoiding Cross Contamination, Equipment Cleaning and Sanitation, Environmental Monitoring Program Allergen Control Program Cleaning and Sanitizing Equipment, Cross Contact, Labeling Controls Process Controls Cooking, pH, Formulation, Refrigeration

Inspections/Compliance Regulatory Strategy Educate before and during inspections Voluntary corrections Cooperative approach Enforcement based on significance of findings

For More Information Web site: Subscription feature available http://www.fda.gov/fsma Subscription feature available To contact FDA about FSMA and find the new online form for submitting questions: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm