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  1. 1. Food Defense Plan Bryan T. Granger Vice President, Compliance, Government Relations and Real Estate C&S Wholesale Grocers, Inc.
  2. 2. Food Safety Modernization Act (“FSMA”) • Prior to passage of FSMA, FDA had no requirements for food facilities to implement mitigation strategies or measures to protect against intentional contamination. • FDA produced general guidance and resources for industry on food defense. The guidance represents the agency’s current thinking on the measures that food establishments may take to minimize the risk that food under their control will be subject to intentional contamination. For more information on the guidance, tools, and resources available to industry, visit the FDA Website. 2
  3. 3. Food Safety Modernization Act Section 103. Hazard Analysis and Risk Based Preventative Controls • Identify and evaluate hazards that may be intentionally introduced (acts of terrorism); • Implement preventative controls to prevent hazards; • Monitor controls and maintain monitoring records; • Conduct verification activities; and • Provision applies to facilities that are registered with the FDA. 3
  4. 4. Food Safety Modernization Act Section 105. Standards for Produce Safety • Establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables • Applies to entities engaging in the harvesting and production of such commodities • Must consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced (acts of terrorism) 4
  5. 5. Food Safety Modernization Act Section 106. Protection against Intentional Adulteration • Issue regulations and guidance to protect against the intentional adulteration of food • Conduct vulnerability assessments of the food supply and determine mitigation strategies • Applies to Facilities that are registered with the FDA. 5
  6. 6. What is a Food Defense Plan (FDP) Food Defense Defined. • The concept of Food Defense is defined as establishing controls that reduce the chances of the food supply from becoming intentionally contaminated by means of a variety of chemicals, biological agents or other harmful substances by people who want to do us harm. • Food Defense is not the same as food safety. Food safety addresses the unintentional contamination of food products by agents reasonably likely to occur in food supply (e.g., E. coli, Salmonella, Listeria). 6
  7. 7. USDA FSIS In 2004 FSIS Proposed Rule for Food Defense Plans: • Federal establishments required to develop, implement and maintain plans to prevent intentional contamination • Plans to be reviewed annually and modified as appropriate In response, industry proposed FSIS allow voluntary adoption of food defense plans: • Industry to work collaboratively with government to achieve goal of food protection, assist with outreach • FSIS to provide industry with tool they need for food defense. Recent tools include the General Food Defense Plan, web-based FSIS Food Defense Risk Mitigation Tool FSIS will consider requiring food defense plans (make rulemaking a priority) if voluntary adoption is unsuccessful 7
  8. 8. 2011 Food Defense Plan Survey Results The sixth food defense plan survey was conducted in July 2011. The types of facilities included meat and poultry slaughter and processing establishments, processed egg products plants, and official import inspection establishments. Overall, 75% of all establishments surveyed have a functional food defense plan (up from 74% in 2010). In 2010, USDA made the voluntary adoption of food defense plans a performance objective. The target is for 90% of establishments to have a functional food defense plan by 2015. July 2011 Food Defense Plan Survey Results Establishme nt Size Percent of Establishments with a Functional Food Defense Plan Processed Egg Products Plants Import Inspection Establishments Overall 96% 100% (none) 96% 84% Large Meat & Poultry Establishments 92% 57% 84% 64% 78% 82% 65% 75% 93% 78% 75% Small Very Small Total 8
  9. 9. Basic Food Defense Program Considerations • • • • • • • • External Physical Security measures Internal Process Control Security measures Personnel security measures Product and supply security measures Crisis management response security measures Internal and eternal communication programs Maintenance of Consumer/Customer confidence Qualifying crisis event facts to support critical corporate decisions 9
  10. 10. Overarching Goals for Food Defense • • • • Know who is in your facility at all times and reasonably control their access Identify the vulnerabilities in your operation, determine the levels of risk and mitigate Investigate, report and mitigate any breaches of security or food defense measures Develop policies, procedures, training to support your food defense measures and plan 10
  11. 11. USDA Guidelines USDA Food Safety and Inspection Service Guide – presents a plan on how to implement a Food Defense Plan. • Step One - Conduct a Food Defense Assessment • Work with security team to determine vulnerabilities of the warehouse • Look at Outside Security, Inside Security, General Security, Shipping and Receiving Security, Mail Handling Security, Personnel Security • Step Two – Develop a Food Defense Plan • Identify the most cost effective preventative actions that can be taken to minimize identified vulnerabilities • Step Three – Implement the Food Defense Plan • Designate person to implement, manage plan • Train personnel in food defense • Assign responsibilities • Assess and Revise plan as needed • Review Product Recall Procedures to contemplate update to address food defense concerns 11
  12. 12. Purpose of the C&S FDP The C&S Food Defense Plan: • Details the framework by which C&S identifies and verifies the controls established toward minimizing the risk of intentional food product contamination or tampering. • C&S implemented its Food Defense Plan in conjunction with USDA guidelines and in preparation for FSMA regulations. • C&S leveraged existing resources at all levels of the organization to develop a robust program. 12
  13. 13. C&S Corporate Food Defense Committee • Corporate Food Defense Committee is responsible for determining vulnerability and consequent actions necessary to address gaps in the food defense assessment matrix. The completed food defense assessment matrix considers both potential internal and external threats. • Following disciplines are represented: Risk Management, Compliance, Security, Operations, Environmental Health and Safety, Environmental Compliance, Food Safety, and Regulatory Compliance. • The Committee reviews the Food Defense Plan at least annually or as required, to ensure ongoing effectiveness throughout the organization. 13
  14. 14. C&S Consideration of FSMA The Corporate Food Defense Committee: • Conducted evaluations to identify “known or reasonably foreseeable hazards,” including hazards that “may be intentionally introduced, including by acts of terrorism”. • Identified processes and consequent actions that reside within existing Corporate Programs that provide preventive controls that assure the identified hazards would be significantly minimized or prevented. • Required monitoring of these controls is ongoing. The establishment of corrective actions, maintenance of monitoring records, instances of nonconformance, and corrective actions are the responsibility of the individual Corporate Program Department Owner. 14
  15. 15. Food Defense Plan Matrix The Food Defense Plan Matrix is made up of 4 sections, with each one detailing existing process’s and actions that are done, and notes which corporate department owns it. The Food Defense Plan Matrix identifies both potential internal and external threats, and makes departments accountable for following procedures to mitigate those threats. The 4 sections are as follows: • Outside Security • General Inside Security • Shipping and Receiving Security • Personnel Security 15
  16. 16. Food Defense Plan Matrix Outside Security- Food Defense measures for the exterior of building. Accountable Departments: Corporate Security and Food Safety • • • • Having controlled or guarded entrances. Facility’s grounds are secure to prevent entry by unauthorized persons. These include fences, gates, guard service, etc. Locations secured with locks, seals, or sensors when unattended such as windows, loading dock doors, roof openings. Procedures in place for people and/or vehicles entering the facility. (Logging of visitors names, vehicles, license plates and reason for visiting; Badge system for identification purposes. Car trunk inspections.) 16
  17. 17. Food Defense Plan Matrix General Inside Security: Accountable Departments: Corporate EHS, Corporate Security, Maintenance, Environmental Compliance • Emergency alert systems and lighting, security camera’s, and visitor restrictions within the facility. • Storage of hazardous materials such as industrial chemicals, cleaning materials and disinfectants. Disposition of hazardous chemicals is also covered. Shipping and Receiving Security: Accountable Departments: Corporate Security, Transportation, Warehouse Operations, Food Safety, Receiving, A/P • • Inbound trailer seal programs, Guard shack sop’s, Bill of Lading review, Delivery logs, Yard Mgt systems (YMS), Store returns. Outbound trailer seal programs, Gate pass procedure, shipping document verification. 17
  18. 18. Food Defense Plan Matrix Personnel Security: Accountable Departments: Corporate Food Safety, Security, Human Resources, Warehouse Operations • • • • Employee training on security procedures at orientation; Employees, visitors, contractors, badge ID/entry procedures; Updated shift rosters; Visitors and contractor car inspections when entering/leaving facility. 18
  19. 19. Food Defense Plan Matrix Corporate Dept Requirement Owner Outside Security 1. Food defense measures in place for the exterior of the building. Dept Document Are the facility’s grounds secured to prevent entry by unauthorized persons (e.g., by locked fence, gate or entry/exit doors, guard service)? Corp Security Corp Food Safety Physical Security Audit- Sec 1 FSA (Q3.02) Is there enough lighting outside the building to properly monitor the warehouse at night/early morning? Corp Security Corp Food Safety Physical Security Audit- Sec 1A FSA (Q3.10) Do emergency exits have self-locking doors and/or alarms? Corp Security Corp Food Safety Physical Security Audit- Sec 2 FSA (Q3.08) 19
  20. 20. Food Defense Plan C&S Auditing Measures • Include assessment of Training on Food Defense Plan in Monthly Facility Self Audits • Aspects of Food Defense Plan are audited through other departments, for instance, the Security Department will perform regular audits which include looking at the surveillance requirements of the Food Defense Plan • Internal Audit will perform assessments of Food Defense Plan as part of regular warehouse audits Inspections • Performed by FSIS or State Department of Health • In general, no comment or positive feedback on plan 20
  21. 21. FSIS Inspections • • • • • • Is there a written Food Defense Plan? Is there an Inside Surveillance System? Is access to receiving and shipping areas restricted? Is there a procedure to verify that incoming/shipped products are consistent with shipping documents? Is there a procedure to observe incoming products for indication of tampering? Where all products observed free from apparent tampering or adulteration? 21
  22. 22. Food Safety Modernization Act • Resources for updates – (to receive updates) – Food Defense FAQs online – Submit any questions you may have to – Website: www.fda.gove/Food/FoodDefense/default.htm 22
  23. 23. Food Defense Plan Questions or Comments ? 23