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Introduction to risk analysis


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Introduction to risk analysis

  1. 1. Bachelors Degree – Agricultural Sciences The Pennsylvania State University Masters Degree – Poultry Science Texas A & M University 20 years of industry experience including regulatory, meat and poultry slaughter and processing, frozen food, bakeries, grain mills, pet food, distribution and retail
  2. 2. Formed in 1977 10,000 employees Inspection services for meat, poultry, eggs produced at approximately 6,200 facilities
  3. 3. Formed in 1906 9,300 employees Inspection services for fruit, vegetables, grains, milk, tobacco, dietary supplements, pharmaceuticals and veterinary products produced at approximately 52,000 facilities
  4. 4.  1880 – first bill introduced to legislature (defeated)  1906 – Pure Food & Drugs Act  1907 – First Certified Color Regulations  1927 – Food & Drug Administration founded  1938 – Federal Food, Drug & Cosmetic Act  1958 – First Generally Recognized as Safe (GRAS) list published  1969 – FDA begins sanitation oversight  1980 – Infant Formula Act  1990 – Nutritional Labeling & Education Act  1993 – Food Code model for foodservice & retail  1994 – Dietary Supplement Health & Education Act  1995 – Seafood HACCP  1998 – Juice HACCP  2000 – Safe Handling for Shell Eggs  2002 – Public Health Security and Bioterrorism Preparedness and Response Act  2006 – Food Allergen Labeling and Consumer Protection Act  2009 – Egg Safety Rule
  5. 5. 10/2009 - Food Safety Modernization Act introduced 1/6/2011 – President Obama signs into law 1/16/2013 – First Rules Published
  6. 6. The Food Safety Modernization Act (FSMA) incorporates a prevention-based philosophy stressing Hazard Analysis & Critical Control Point principles
  7. 7.  Do you feel the Food Safety Modernization Act will have a big impact on how you conduct business?
  8. 8.  Globalization ◦ 15 percent of U.S. food supply is imported  Food supply more high-tech and complex ◦ More foods in the marketplace ◦ New hazards in foods not previously seen  Shifting demographics ◦ Growing population (about 30%) of individuals are especially “at risk” for foodborne illness
  9. 9. Involves creation of a new food safety system Broad prevention mandate and accountability New system of import oversight Emphasizes partnerships Emphasizes farm-to-table responsibility Developed through broad coalition
  10. 10. Prevention Inspections, Compliance, and Response Import Safety Enhanced Partnerships
  11. 11.  Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place  FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements  Can require mandatory certification for high-risk foods  Can deny entry if FDA access for inspection is denied  Requires food from abroad to be as safe as domestic
  12. 12. The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.
  13. 13. August 2012 14 • Creating a food safety culture starts with every one of us • As leaders, we must take accountability for engaging our employees and enhancing the food safety culture
  14. 14. How would you describe the Food Safety Culture in your work environment?
  15. 15. 16 Passive Operate just to pass the “audit” Reactive Food Safety is important, we address it after an event Calculative We have systems in place to manage all hazards Proactive We work on problems that we still find Generative Food safety is built in the way we work and think
  16. 16. Where is your facility / work environment based upon the previous slide? What steps need to be taken to continue to evolve?
  17. 17. Mandatory Food Safety Programs (HACCP) for each facility FDA Authority for Recall Implementation cost of $701 mil, annualized $472 mil Still largely unknown due to delays in rulemaking
  18. 18. What do you think will be the biggest impact as the law stands today? Where would you focus your rule making?
  19. 19. Do you have a HACCP plan for your facility? Do your customers already expect that you do?
  20. 20. Risk management is defined for the purposes of the Codex Alimentarius Commission as "The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.
  21. 21. Please give current examples of active risk management within your organization.
  22. 22. The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.
  23. 23. Risk assessment is defined for the purposes of the Codex Alimentarius Commission as "A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization."
  24. 24.  "The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods."
  25. 25.  "The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable."
  26. 26.  "The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant."
  27. 27.  "The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment."
  28. 28.  Biological ◦ Bacteria ◦ Mold ◦ Viruses ◦ Prions  Chemical ◦ Toxins ◦ Pesticides ◦ Drug Residues ◦ Allergens  Physical ◦ Metal ◦ Stones ◦ Jewelry ◦ Glass
  29. 29.  Break in small groups  Identify 2 instances where it may be beneficial to perform a risk assessment  Why