Intentional Adulteration Phase 2 Workgroup 1

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

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

Proposed Requirements 4

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

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

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

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

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

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

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

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

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

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