Mr. John Guzewich

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  • Questions?
  • Good morning. Thank you for inviting me to speak today. Your conference is a timely event given the recent release of the President’s Import Safety Action Plan and the FDA’s Food Protection Plan.
  • Another challenge is that the number and variety of agents associated with foodborne illness has steadily grown over the last few decades.
  • Recent outbreaks linked to fresh produce, peanut butter, and pet foods show how FDA responds quickly to contain food safety problems. While this level of response needs to be maintained and even enhanced, there is also a need to focus more on building safety into products right from the start to meet the challenges of today. The FDA will work with the private sector to build on industry efforts to ensure product safety. This shift to an increased emphasis on prevention is at the core of FDA’s Food Protection Plan. Prevention needs to be augmented then by targeted Agency interventions that focus inspection and testing on the areas of greatest risk. This will reduce the likelihood that contaminated products will reach consumers. However, even the best system in the world cannot prevent all incidents of foodborne illness. Along with prevention and intervention, faster and more focused response is needed once a problem is detected.
  • In addition to the elements of prevention, intervention and response , the Plan contains 4 cross cutting principles: 1. A focus on the risks over a product’s life cycle from production to consumption; 2. The need to target Agency resources to achieve maximum risk reduction; 3. The need to address both unintentional and deliberate contamination; and 4. The use of science and modern technology systems.
  • The Plan is organized around the three integrated elements of protection: Preventing foodborne illnesses in the first place; Intervening with risk-based FDA actions at critical points in the food supply chain; and Responding rapidly when contaminated food or feed is detected. Under each element, there is a list of planned FDA actions and proposed legislative authorities. Implementation of the FDA actions will begin immediately, be phased in over time, and integrated with the Administration’s Import Safety Action Plan. All will build on existing partnerships with stakeholders and other partners, such as Federal, State, local and foreign government agencies. On requests for new legislative authorities, we will work with Congress to ensure understanding of the design and need for these new authorities.
  • “ Response” is Core Element #3 Under this core element, there are 2 key response steps: Improve immediate response and Improve Risk Communications The Plan calls for steps to better coordinate a rapid emergency response among FDA, state and local government response teams as appropriate, and improve communications to the public, industry and other partners. This will better protect public health, help reduce the economic hardship affected industries face, and most important maintain consumer confidence in the U.S. food supply following an incident.
  • Recent food safety threats have demonstrated the importance of FDA’s emergency response system. In particular, effective traceback is critical in rapidly containing potential risks. Working with partners, FDA will pursue improvements to the current trace-back process and develop an action plan for implementing process improvements to more rapidly and precisely track the origin and destination of contaminated foods, feed, and ingredients. Like you, we are searching for effective and efficient traceability of products. We know that standards and technology will be a large part of the solution and welcome your input. As part of our overall response effort, FDA will work with selected federal, state, and local testing labs to communicate real-time testing results among FDA and lab members.
  • Two new legislative authorities proposed in the “Response” section of the plan are: Mandatory Recall of Food Products, and Enhanced access to food records during emergencies. While voluntary recalls have in large part been successful, there are rare situations in which firms are unwilling to conduct a recall. In such situations FDA needs the ability to require a firm to conduct a recall to ensure the prompt and complete removal of food from distribution channels. This authority would be limited to foods that the Secretary has reason to believe are adulterated and present a threat of serious adverse health consequences or death. It would be imposed only if a firm refuses or unduly delays conducting a voluntary recall. Additionally, during food-related emergencies, the FDA needs more complete and streamlined access to records necessary to identify the source of foodborne illness and take needed action. Improved access to information, including records related to an article of food or related articles of food that may present a threat, will enhance FDA’s ability to identify problems, respond quickly and appropriately, and protect the public health.
  • During an emergency, important messages must be communicated clearly and through multiple forms of media to be effective in reaching consumers, retailers, public health officials, industry and other key stakeholders to ensure that potentially-harmful products are removed promptly from commerce.
  • Mr. John Guzewich

    1. 1. FDA Current Thinking on Foodborne Outbreak Investigations Jack Guzewich FDA/CFSAN
    2. 2. FDA Policies & Procedures <ul><li>FDA Crisis Management Plan </li></ul><ul><li>FDA Chemical & Biological Emergency Response Plan </li></ul><ul><li>CFSAN Emergency Response Plan </li></ul><ul><li>These include: </li></ul><ul><ul><li>Coordination </li></ul></ul><ul><ul><li>Roles & responsibilities </li></ul></ul><ul><ul><li>Communications </li></ul></ul>
    3. 3. FDA Roles & Responsibilities <ul><li>Office of Crisis Management </li></ul><ul><ul><li>Office of Emergency Operations </li></ul></ul><ul><li>Office of Regulatory Affairs </li></ul><ul><ul><li>District Offices </li></ul></ul><ul><ul><li>Field laboratories </li></ul></ul><ul><li>Center for Food Safety & Applied Nutrition </li></ul><ul><ul><li>Emergency Coordination & Response Team </li></ul></ul><ul><ul><li>Scientific & policy experts </li></ul></ul>
    4. 4. Anatomy of an Outbreak Investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    5. 5. Surveillance <ul><li>Local & State Health Departments </li></ul><ul><ul><li>Surveillance & detection </li></ul></ul><ul><li>Laboratory surveillance </li></ul><ul><li>Consumer complaints </li></ul><ul><li>CDC consultation </li></ul><ul><li>Regulatory Surveillance </li></ul><ul><ul><li>Inspections </li></ul></ul><ul><ul><li>Samples </li></ul></ul>
    6. 6. Anatomy of an Outbreak Investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/Recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    7. 7. Epidemiologic Investigation <ul><li>Conducted by state and local public health agencies, </li></ul><ul><li>FDA relies on CDC vetting of epi & lab investigation data & CDC’s recommendations </li></ul><ul><li>FDA reviews the epi and lab investigation data before we act </li></ul>
    8. 8. Anatomy of an Outbreak Investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/Recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    9. 9. Laboratory Investigation <ul><li>Clinical </li></ul><ul><li>Food </li></ul><ul><li>Environmental </li></ul><ul><li>PulseNet </li></ul>
    10. 10. Anatomy of an Outbreak investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/Recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    11. 11. Environmental Investigation <ul><li>Environmental investigation: </li></ul><ul><ul><li>Point of service </li></ul></ul><ul><ul><li>Along the chain of distribution </li></ul></ul><ul><ul><ul><li>i.e. distributor, manufacturer, re-packer, farm </li></ul></ul></ul><ul><ul><li>Identify possible sources of contamination </li></ul></ul><ul><ul><ul><li>not your normal inspection </li></ul></ul></ul>
    12. 12. Environmental Investigation <ul><li>Critical to identifying where the contamination occurred and at which point(s) in the distribution chain </li></ul><ul><li>FDA won’t be involved if contamination occurred at point of service; that’s within a state’s jurisdiction </li></ul><ul><li>Usually involves sample collection </li></ul>
    13. 13. Anatomy of an Outbreak Investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/Recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    14. 14. Response/Recall <ul><li>Response </li></ul><ul><ul><li>Criteria: </li></ul></ul><ul><ul><ul><li>Epidemiological association </li></ul></ul></ul><ul><ul><ul><li>Laboratory association </li></ul></ul></ul><ul><ul><ul><li>Negative environmental at point of service </li></ul></ul></ul><ul><ul><ul><li>Population still at risk? </li></ul></ul></ul><ul><li>Recall </li></ul><ul><li>Press </li></ul>
    15. 15. Anatomy of an Outbreak Investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/Recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    16. 16. Traceback Diagram CA case CA case CA case CA case CA case WA case Country A Country A Country A Country B Country C Dist A Dist B Dist C Country D Country A Dist Z
    17. 17. Anatomy of an Outbreak Investigation <ul><li>Surveillance </li></ul><ul><li>Epidemiological investigation </li></ul><ul><li>Laboratory analysis </li></ul><ul><li>Environmental investigation </li></ul><ul><li>Response/Recall </li></ul><ul><li>Traceback/traceforward </li></ul><ul><li>Farm investigation </li></ul>
    18. 18. Farm Investigations <ul><li>What we look for: </li></ul><ul><ul><li>Note : Not your typical inspection </li></ul></ul><ul><ul><li>Sources of Microbial Contamination </li></ul></ul><ul><li>What we’ve found: </li></ul><ul><ul><li>Team approach is critical (investigator, sanitarian [water], microbiologist, wildlife biologist, epidemiologist) </li></ul></ul><ul><ul><li>Planning and Coordination is key </li></ul></ul>
    19. 19. Lessons Learned From Past Investigations <ul><li>Detection </li></ul><ul><ul><li>Variable capacity in different state and local public health agencies </li></ul></ul><ul><ul><li>Some states and locals do not notify FDA or CDC </li></ul></ul><ul><li>Epidemiologic Investigation </li></ul><ul><ul><li>How good is the epi data and who decides? </li></ul></ul><ul><ul><li>What if CDC is not involved? </li></ul></ul><ul><ul><li>How do we use local investigations in enforcement? </li></ul></ul><ul><ul><li>Locals need to keep data. We may need it years later. </li></ul></ul>
    20. 20. Lessons Learned From Past Investigations <ul><li>Traceback </li></ul><ul><ul><li>Poor and incomplete record keeping </li></ul></ul><ul><ul><li>Slow response in providing records </li></ul></ul><ul><ul><li>Multiple sources of the same product at the same time at various steps in the system </li></ul></ul><ul><ul><li>Records from one point do not line up with records from the next point </li></ul></ul><ul><ul><li>Processors can not match finished product with incoming raw ingredients </li></ul></ul><ul><ul><li>Tracebacks often require huge amounts of resources </li></ul></ul>
    21. 21. Lessons Learned From Past Investigations <ul><li>Response </li></ul><ul><ul><li>Need to be fast and right </li></ul></ul><ul><ul><li>Legal review requirements </li></ul></ul><ul><ul><li>Use of Incident Command/NIMS </li></ul></ul><ul><li>Information Technology </li></ul><ul><ul><li>Servers crash, Blackberries fail </li></ul></ul><ul><ul><li>Communicating with field investigation teams </li></ul></ul><ul><ul><li>Information management </li></ul></ul><ul><ul><ul><li>eRoom </li></ul></ul></ul><ul><ul><ul><li>Emergency Operations Network </li></ul></ul></ul>
    22. 22. Lessons Learned From Past Investigations <ul><li>Communication </li></ul><ul><ul><li>Information overload (phone, e-mail) </li></ul></ul><ul><ul><li>Need for early notification of consumers </li></ul></ul><ul><ul><li>How to keep everyone informed inside and outside government, domestic and international? </li></ul></ul><ul><ul><li>Secondary and tertiary distribution, how to keep everyone informed? </li></ul></ul><ul><ul><li>Need for clarity on roles and responsibilities </li></ul></ul><ul><ul><li>Coordinating public statements within and among agencies </li></ul></ul><ul><ul><li>Restrictions in what can be shared </li></ul></ul>
    23. 23. Lessons Learned From Past Investigations <ul><li>Decision Making </li></ul><ul><ul><li>Criteria for FDA to get involved </li></ul></ul><ul><ul><li>Criteria to initiate traceback, recall, press </li></ul></ul><ul><ul><li>When is perishable product out of distribution so press is not warranted? </li></ul></ul>
    24. 24. Lessons Learned From Past Investigations <ul><li>Environmental/Regulatory Investigation </li></ul><ul><ul><li>Standardized protocols and forms </li></ul></ul><ul><ul><li>Investigation VS Inspection </li></ul></ul><ul><ul><li>Multi-organization coordination </li></ul></ul><ul><ul><ul><li>CalFERT </li></ul></ul></ul><ul><li>Recalls </li></ul><ul><ul><li>Effectiveness checks show that some products remain in the system e.g., food pantries </li></ul></ul><ul><ul><li>How to coordinate with industry, states and locals? </li></ul></ul>
    25. 25. Lessons Learned From Past Investigations <ul><li>General Comments </li></ul><ul><ul><li>Staff burn out </li></ul></ul><ul><ul><li>Staff does best in emergencies those things that they are familiar with </li></ul></ul><ul><ul><li>Exercises and training are always needed </li></ul></ul><ul><ul><li>Tracebacks do take time </li></ul></ul><ul><ul><li>Environmental investigations take time </li></ul></ul><ul><ul><li>Laboratory analysis does take time </li></ul></ul>
    26. 26. Questions?
    27. 27. U.S. Food and Drug Administration Food Protection Plan
    28. 28. <ul><li>Campylobacter jejuni </li></ul><ul><li>Cryptosporidium parvum </li></ul><ul><li>Shiga toxin-producing E. coli </li></ul><ul><li>Noroviruses </li></ul><ul><li>Vibrio cholerae O139 </li></ul><ul><li>Vibrio parahaemolyticus </li></ul><ul><li>Campylobacter fetus </li></ul><ul><li>Cyclospora cayetanesis </li></ul><ul><li>Listeria monocytogenes </li></ul><ul><li>Salmonella Enteritidis </li></ul><ul><li>Vibrio vulnificus </li></ul><ul><li>Yersinia enterocolitica </li></ul><ul><li>Enterobacter sakazakii </li></ul><ul><li>Salmonella Typhimurium DT104 </li></ul>Changes and Challenges New Foodborne Pathogens Since 1977
    29. 29. The Food Protection Plan
    30. 30. <ul><li>Focus on risks over a Product’s life cycle – </li></ul><ul><li>Target resources to achieve maximum risk reduction </li></ul><ul><ul><li>Gather the science </li></ul></ul><ul><ul><li>Rank products based on risk </li></ul></ul><ul><ul><li>Focus prevention and intervention </li></ul></ul><ul><li>Integration of food safety and food defense </li></ul><ul><li>Use science and modern technology systems </li></ul>Food Protection Cross-Cutting Themes
    31. 31. Food Protection Plan <ul><li>Three core elements: </li></ul><ul><ul><li>Prevention </li></ul></ul><ul><ul><li>Intervention </li></ul></ul><ul><ul><li>Response </li></ul></ul><ul><li>Under each element </li></ul><ul><ul><li>Key steps </li></ul></ul><ul><ul><ul><li>FDA actions </li></ul></ul></ul><ul><ul><ul><li>Legislative proposals </li></ul></ul></ul>
    32. 32. Response Core Element No. 3 <ul><li>Improve Immediate Response </li></ul><ul><li>Improve Risk Communication to the Public, Industry, and Other Stakeholders </li></ul>
    33. 33. Response Immediate Response <ul><li>Agency Actions: </li></ul><ul><li>Enhance capabilities of FDA’s Emergency Operations Network Incident Management System </li></ul><ul><li>With stakeholders, develop an action plan for more effective traceback (process/technologies) of contaminated food and feed </li></ul><ul><li>Enhance IT networking for real-time lab communication </li></ul>
    34. 34. Response Immediate Response <ul><li>Legislative Proposals: </li></ul><ul><li>Mandatory Recall of Food Products </li></ul><ul><ul><li>Reasonable belief the food is adulterated and presents a risk of serious illness or death </li></ul></ul><ul><ul><li>Used only when firm refuses or delays a voluntary recall </li></ul></ul><ul><li>Enhanced Access to Food Records during Emergencies </li></ul><ul><ul><li>Current access requires reasonable belief that a food is adulterated AND presents a risk of serious illness or death </li></ul></ul><ul><ul><li>Would allow access when specific adulterant has not been identified </li></ul></ul><ul><ul><li>Expand access to records for related foods, such as food produced on the same production line </li></ul></ul>
    35. 35. Response Risk Communication to Stakeholders <ul><li>Agency Actions: </li></ul><ul><li>Design and conduct consumer communications and behavior response studies </li></ul><ul><li>Use study information to update Food Protection Risk Communication Plan with strategies to effectively communicate with consumers </li></ul><ul><li>Website for food protection information </li></ul><ul><li>In a food emergency, implement Food Protection Risk Communication Plan to get appropriate information to consumers, retailers, industry, healthcare community, public health officials, and other stakeholders </li></ul>

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