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Food Safety Modernization Act Signed into law January 2011 Focus of food safety system from reactive to preventative New FDA Authority Mandatory Recall authority Inspection of producers and processors Import Requirements Seven new rules for implementation

FSMA – Produce Rule Our Focus Produce Safety Rule Establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption The biggest regulatory lift for states

FSMA – Produce Rule FDA Released Produce Rule Funding Opportunity Awards were announced in September 2016 Reapplication process opens soon NASDA partnering with States and FDA on implementation Annual meetings February 2016 and 2017

FSMA – Produce Rule Funding Opportunity Infrastructure Dollars (Competition A) Planning, inventory, research, hiring, IT, education, outreach Inspection Dollars (Competition B) Planning, compliance, inspection, enforcement

FSMA – Produce Rule ISDA Coordination with ISDH and Purdue University Outreach (ISDA) Producers, industry groups, government agencies, academia Informational materials and events Education (Purdue & ISDH) Technical Training through use of Produce Safety Alliance curriculum

FSMA – Produce Rule Funding Available Funding Tiers based on number of farms growing “covered” produce Total Potential Award for Indiana over 5 years is $3.6 million First year award of $500,000 $130,000 will to ISDA for outreach activities In the process of hiring our Outreach Coordinator

FSMA – Produce Rule Possible Legislative Action Limited existing authority to enact Produce Rule Possible changes in 2018 session of General Assembly Need to examine other rules to determine if changes are needed

FSMA – The Other Rules Preventive Controls for Human Food Preventive Controls for Animal Food Foreign Supplier Verification Third Party Certification Food safety audits Sanitary Transportation Rule Intentional Adulteration

FSMA - Animal Food Covered facilities must implement Current Good Manufacturing Practices (CGMPs) Covered facilities must establish and implement a food safety system that includes, Hazard analysis (identification of biological, chemical and physical hazards) Preventive controls (ensure hazards will be minimized or prevented) Oversight and management of preventive controls (monitoring and verification) Recall plan

Thank You! Jeff Cummins Director, Policy and Regulatory Affairs 317-517-9445 Jecummins@isda.in.gov Katie Nelson Program Manager, Policy and Regulatory Affairs 317-517-7526 kanelson@isda.in.gov