1. SAI K. RAMASWAMY DR. GRETCHEN A. MOSHER NC-213,KANSAS CITY HARPC: Preventive Controls & Food Safety Implications 1 NC-213The U.S. Quality Grains Research Consortium

2. Food Safety Modernization Act (FSMA) Most sweeping food safety reform: signed 2011 34 sections already enforced, 7 sections in rulemaking Wide impact- Farmers to Grain handlers to Processors to Importers Prevention rather than reaction 2

3. Good Manufacturing Practices (GMP’s) (Pre-FSMA) 3 Systematic program to ensure food products meet safety, quality & legal requirements HACCP (Hazard Analysis and Critical Control Point) one such popular program Focus on managing critical controls to prevent, eliminate or reduce hazards Mostly a voluntary program

4. GMP’s - post FSMA 4 Same goal different approach to handle safety, quality & legal requirements Identify hazards and controls measures + Risks associated with the hazards Required to implement Hazard Analysis and Risk-Based Preventive Controls (“Harp sea”) Mandatory for many of food & grain handling facilities registered with FDA

5. HARPC (“Harp sea”) Preventive Controls- Section 103 of FSMA  For Human Food  For Animal food  Intentional adulteration ( not addressed by HARPC) Different from HACCP despite common concepts (HACCP subset of HARPC) Applies to all facilities that process, pack or hold food and feed E.g.: Grain Elevators 5

6. HARPC- Key Elements 6 Identify & evaluate hazards Create programs/procedures to mitigate or prevent hazards Develop methods to effectively monitor preventive controls Maintain records of monitoring Specify corrective measures in case of issues with preventive controls Re-analyze

7. HACCP Vs. HARPC HACCP Worldwide standard Applies to a wide variety of food products Focus on control steps Requires qualifies team HARPC US standard Applies to FDA regulated products Preventive programs Needs qualified individual 7

8. HACCP Vs. HARPC Compliance HACCP Voluntary across most food industry Mandatory for certain foods like seafood, juice, meat and poultry HARPC Mandatory for all facilities requiring FDA registration Exemptions for FDA mandatory HACCP programs 8

9. GMP’s at Grain Elevators Currently voluntary Mandatory to maintain proper records & register with FDA for traceability Implementing quality management to handle globalization and legislation risks Also using quality management as a tool to handle food safety as well as worker safety risks 9

10. Business FSMA Quality  Meeting customer requirements  Prevent grain spoilage  Product safety Financial  Revenue loss  Recovering preservation & storage costs Safety  Personnel safety Biological Chemical Physical Allergens Radiological 10 Potential Risks at Grain Elevators

11. Preventive Controls for Quality Risks 11 Standardize operation Improve inventory management Minimizing variance by monitoring and measuring Empower employees

12. Quality Management & Preventive Control 12 QMS processes facilitate:  Documentation of work tasks for control and consistency  Clear statement of decision making responsibilities  Provides statistical targets for quality traits  Improvement of management processes for inventory  Established methods for problem solving and appropriate corrective actions

13. HARPC & Quality Management Plan Identify & evaluate hazards Do Create programs to mitigate/prevent hazards and develop preventive controls Check Monitor and maintain records Act Apply corrective measures when needed and re-analyze 13

14. Recommendations 14 Grain elevators can manage grain quality and product safety with QMS QMS can help manage inventory and help decision making related to :  Preservation methods  Storage options  Blending  Shipping details

15. Recommendations cont.. 15 Grain elevators implementing QMS are better suited to handle changes due to new legislation QMS focus on control, consistency, and reproducibility helpful in hazard management part of HARPC program QMS could assist in managing risk of intentional adulteration and keeping the facility secure

16. Questions 16

17. Potential Risks at Grain Elevators 17 Quality  Meeting customer requirements  Prevent grain spoilage  Product safety Financial  Revenue loss  Recovering preservation & storage costs Safety  Personnel safety