1. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov Food Safety Modernization Act Update North American Agricultural Marketing Officials July 15, 2015

2. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov –Resources for More Information –FSMA, the Food Safety Modernization Act FDA’s Regulations & Overview USDA Providing Technical Assistance to FDA –Suite of 7 Rules & Related Activity –Implementation Strategy & NASDA –Important Dates –Wrap-Up Today’s Presentation

3. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov Resources for More Information http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

4. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov FDA’s FSMA Rulemaking Highlights Suite of proposed regulations 1.Preventive Controls for Human Foods 2.Preventive Controls for Animal Feed 3.Produce Safety 4.Foreign Supplier Verification Program 5.Accredited 3 rd Party Auditors & Certifying Bodies 6.Sanitary Transportation 7.Intentional Adulteration

5. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov Focus on farm, commodities & practices –Growing, harvesting, packing & holding –Domestic production & Imports Key Requirements 1.Agricultural Water & Processing Water 2.Biological Soil Amendments of Animal Origin 3.Buildings, Equipment & Tools 4.Wildlife & Domestic Animals 5.Worker Training & Personal Health & Hygiene 6.Postharvest Handling 7.Alternatives & Variance Coverage – Produce Safety Regulation

6. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov Technical Assistance –Updated GAPs Guidance, Co-Management Guidance, Implementation & Compliance Guide –National Coordination Center – FSMA section 209 Regional Centers by USDA NIFA and FDA –Produce Safety Alliance –Research Needs –Outreach Activities For both industry and regulatory community FDA’s Rulemaking Highlights

7. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov Produce Safety Alliance Cooperative Agreement - FDA, USDA & Cornell Collaborators from more than 35 Land-grant Universities, Cooperative Extension Programs and Farmers involved Developing Standardized Curriculum to help farmers meet the Produce Safety Rule Training Requirement –Train-the-Trainer 2-day session –Grower (Farmer) Training 1-day session with flexible delivery –Flexibility to add region-specific materials, food safety plan development, water sampling protocols, etc. http://producesafetyalliance.cornell.edu/

8. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov Generalized Compliance Strategy “Supporting public & private parties involved in audits and other accountability functions with technical assistance and other collaborative support” Implementation Strategy –Who is involved and current status? NASDA Workgroup –Readiness Review Project & Operational Plan USDA’s GAPs Programs FDA’s FSMA Implementation

9. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov ~~ Hypothetical ~~ ~~ Hypothetical ~~ Accountability Continuum Potential Sources of Accountability –Leveraging Existing Mechanisms within the Produce Stakeholder Community Why Leverage? –Limited resources at regulatory agencies –Significant inputs already invested by soon-to-be regulated community

10. ~~ Hypothetical ~~ ~~ Hypothetical ~~ Accountability Continuum

11. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov –Court-ordered Consent Decree dates –Publication, Effective & Compliance dates (estimated) October 31, 2015 (publication date) December 30, 2015 (effective date = publication date + 60 days) When will your farmers need to be in compliance? Important Dates - Produce Safety Regulation Size categoryAnnual produce sales Compliance dates -- except for certain water provisions Compliance dates -- for certain water provisions Very Small Farm > $25,000 to $250,000 4 years Dec 2019 Additional 2 years Small Farm> $250,000 to $500,000 3 years Dec 2018 Additional 2 years All Other Farms (larger than small) > $500,0002 years Dec 2017 Additional 2 years

12. www.fda.govwww.fda.gov & www.ams.usda.govwww.ams.usda.gov –Recap –Where to get more information –Questions & Answers… Wrap-up