1. Intentional Adulteration Phase 2 Workgroup http://www.fda.gov/fsma 1

2. Summary of Requirements Written food defense plan, including −Actionable process steps −Focused mitigation strategies −Monitoring −Corrective actions −Verification Training 2

3. Summary of Requirements Identification of actionable process steps using “key activity types” or a vulnerability assessment –Determination of the presence of “key activity types” similar to a hazard analysis –Actionable process steps similar to critical control points Identification and implementation of focused mitigation strategies –Strategies similar to preventive controls 3

4. Proposed Requirements 4

5. Who is Covered? Facilities that manufacture, process, pack or hold human food In general, facilities required to register with FDA under sec. 415 of the FD&C Act Applies to domestic and imported food Some exemptions and modified requirements are being proposed. 5

6. Phase 2 Workgroup Mission and Charge: −Work in collaboration with the other FSMA workgroups and leverage as appropriate to determine a strategy for implementing the FSMA regulations for protection against intentional acts of adulteration in human foods −Develop and communicate strategies encompassing compliance, awareness, training and outreach, inspection and enforcement, information technology (IT) requirements, and performance metrics −Reminder – we are the last of the seven FSMA rules to finalize. Phase 2 is beginning our work 6

7. Phase 2 Workgroup First Go-Away with Steering Committee held March 16-17, 2015 Membership (as of now-expected to increase): −CFSAN – FDECS, OC, IAS −ORA – OPRM, OFFO, DHRD, DD, Field −State participation 7

8. Phase 2 Workgroup Overriding themes: −Leverage with Human Food Preventive Controls (PC) and other FSMA Phase 2 workgroups when appropriate −Build as much as possible on the 14-plus years of work that FDA has completed on intentional adulteration 8

9. Industry Education/Outreach/ Technical Assistance Build on 14-plus years of food defense awareness and training Leverage with existing partners −industry, government, academia Update and add to existing intentional adulteration guidance and technical assistance documents already available 9

10. Training Recognize the need to establish training programs for regulators and industry −Ensure consistency in the performance and quality of inspections −Ensure industry has the information and training needed to comply with the regulation −Utilize and leverage with the FSMA training workgroup 10

11. Inspections, Compliance/Enforcement IA inspection must be tailored to the unique challenges of food defense Establish an efficient and effective system, potentially leveraging resources being used to conduct food safety inspections −Food defense plans may be held at corporate but implemented locally −Determination of adequacy of plan −Determination of assessing implementation of plan 11

12. Data Collection, Analysis, IT Build on 14-plus years of working with stakeholders on intentional adulteration Leverage Preventive Controls IT framework, adapting for IA as necessary 12

13. Performance Goals and Metrics Define the results to be achieved -status: early in process -drawing from other strategic frameworks -leverage with Human Preventive Controls Measuring progress (metrics) −preliminary thinking to use similar themes −examples, metrics to be developed toward increased understanding of rule (training), increased access to materials (guidance), and focused utilization of regulatory resources 13

14. Breakout Sessions Session 1 Discussions −Training −Alliance formation Session 2 Discussions −Inspection approaches −Dedicated cadre −Tiered inspections −Adequacy −Implementation 14