1. 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

2. 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

3. 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

4. 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

5. 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

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

7. 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) .

8. 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

9. 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

10. 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

11. 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

12. 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

13. TAN Number of Inquiries

14. 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 and go to Contact Us
Common TAN questions posted

15. 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

16. 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

17. 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

18. 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

19. Preventive Controls for Human Food Rule

20. Preventive Controls Human Food Compliance Dates*

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

22. 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

23. 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

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

25. For More Information Web site: Subscription feature available
Subscription feature available
To contact FDA about FSMA and find the new online form for submitting questions: