John Kvenberg, Ph.D. Deputy Director, Office of Compliance

1. FDA/CDC Action PlanReducing the Risk of Listeria monocytogenes2003 Update of the Listeria Action Plan John Kvenberg, Ph.D. Deputy Director, Office of Compliance Center for Food Safety and Applied Nutrition December 2003

2. Strategic Goals Efficient Risk ManagementUse science-based efficient risk management strategies to target highest L. monocytogenes risk products and practices Empowering Consumers: Improving Health through Better InformationConsumer messages and information to reduce exposure to L. monocytogenes, particularly by vulnerable groups such as the elderly and pregnant women Improving Consumer SafetyReducing L. monocytogenes risk with improved food manufacturing and distribution

3. History: 2001 HHS/USDA Joint Action Plan • Published:January 19, 2001 for public comment • Scope:Ready-to-eat foods identified in the risk assessment as warranting control and warranting additional data • Eight action areas:short and long-term implementation timelines

4. Goal of the Action Plan Achieve a 50% reduction in L. monocytogenes illness by 2005 • Accelerated work toward Healthy People 2010 Objective • 50% reduction from 1996 to 2005 = 0.5 to 0.25 cases per 100,000 people • Preliminary 2002 FoodNet Data - 0.27 cases per 100,000 people

5. 2003 Update - Action Plan Six Areas of Action: • Develop and revise guidance for processors that manufacture or prepare ready-to-eat foods and develop or revise guidance for retail and food service and institutional establishments. • Develop and deliver training and technical assistance for industry and food safety regulatory employees. • Enhance consumer and health care provider information and education efforts. • Review, redirect, and revise enforcement and regulatory strategies, including microbial product sampling. • Enhance disease surveillance and outbreak response. • Coordinate research activities to refine the Risk Assessment, enhance preventive controls, and support regulatory, enforcement, and educational activities.

6. 2003 Update - Action PlanContinued from 2001 1. Develop & revise guidance for processors that manufacture or prepare ready-to-eat foods and for retail establishments • Controlling L. monocytogenes in refrigerated, RTE foods – finalize and publish guidance document • Continue to work with the Codex Alimentarius Commission on the “Proposed Draft Guidelines for the Control of L. monocytogenes in Foods” • Continue to work with Michigan State University to study the transfer rates between foods contaminated with L. monocytogenes and food contact surfaces

7. 2003 Update - What’s New • Develop & revise guidance for processors that manufacture or prepare ready-to-eat foods and for retail establishments • Guidance on enhancing the safety of the production of milk and milk products • Guidance on enhancing the safety of the production of fresh-cut produce • Design a project with smoked seafood operations to pilot L. monocytogenes control measures • Review Food Code provisions that may address L. monocytogenes control measures

8. 2003 Update - Action PlanContinued from 2001 2. Develop and deliver training/technical assistance for industry and food safety regulatory employees • Develop long distance teaching instruments • Update existing programs • Review existing training programs and revise, as needed, based on the findings of the L. monocytogenes Risk Assessment

9. 2003 Update - What’s New 2. Develop and deliver training/technical assistance for industry and food safety regulatory employees • Provide technical assistance to small and very small dairy facilities • Develop a training segment on auditing the effectiveness of L. monocytogenes controls

10. 2003 Update - Action PlanContinued from 2001 3. Enhance health care provider & consumer information & education efforts • focus consumer messages • continue to inform, educate, and develop medical guidance for health care professionals about the diagnosis, treatment, and prevention of L. monocytogenes caused illness • achieve maximum outreach to women and women’s health care professionals • collaborate with other public and private organizations

11. 2003 Update - What’s New 3. Enhance health care provider & consumer information & education efforts • Emphasize the storage of foods at 40°F or lower and for short periods of time • Work with refrigerator manufacturers on equipment design enhancements to facilitate consumer efforts to achieve optimum temperatures • Target education campaigns to Hispanic women of child-bearing age about importance of eating only fresh soft cheeses made with pasteurized milk

12. 2003 Update - Action Plan 4. Review & redirect enforcement & regulatory strategies including microbial product sampling • Domestic inspections - • Increase inspections of firms that produce higher risk RTE foods, and • Shift resources away from very low to low risk foods and increase resources to moderate and high risk foods • Focus domestic and import surveillance sampling program on higher risk products for L. monocytogenes testing

13. 2003 Update - What’s New • Review & redirect enforcement & regulatory strategies including microbial product sampling • Develop action plan to address the unlawful importation of raw milk soft cheeses • Work with states to eliminate the unlawful production and sale of raw milk soft cheeses • Develop a model statue that will prohibit the sale of raw milk for dissemination to those states which still permit its sale • Review current GMP regulations and evaluate whether to revise these regulations based on the Risk Assessment

14. 2003 Update - What’s New 4. Review & redirect enforcement & regulatory strategies including microbial product sampling • Seek advice from NACMCF on the scientific basis for redefining “pasteurized” - 2003 Farm Bill (Public Law 107-171) • Consider revising dairy standards to allow use of bacteriocins • Seek advice from NACMCF on the scientific basis for establishing safety-based “use by” shelf life date labeling for refrigerated, ready-to-eat foods

15. 2003 Update - Action PlanContinued from 2001 5. Enhance disease surveillance & outbreak response • Increase and enhance the number of laboratories capable of L. monocytogenes analysis through CDC’s “PulseNet” labs • CDC will continue to work with state and local health departments to improve detection and reporting of L. monocytogenes illnesses • CDC will continue enhanced monitoring of L. monocytogenes illnesses to identify and evaluate trends in disease occurrence • CDC will continue work on two projects to attribute the percentage of foodborne illness cases from L. monocytogenes to various vehicles based on epidemiologic data

16. 2003 Update - What’s New 5. Enhance disease surveillance & outbreak response • CDC will complete and publish a comprehensive case-control study • CDC will work with FDA to develop improved methods for the use of surveillance data in assessing the public health impact of regulatory and outreach programs

17. 2003 Update - Action Plan • Coordinate research activities to refine the Risk Assessment and enhance preventive controls • Continue to coordinate, support, and conduct research to evaluate the effectiveness of commercial treatments; preservatives, bacteriocins, irradiation that may eliminate or reduce L. monocytogenes • Continue to seek data on the frequency and concentration of L. monocytogenes in a variety of ready-to-eat foods to enhance exposure assessment databases • Continue CFSAN detection and quantification methods research

18. 2003 Update - What’s New • Coordinate research activities to refine the Risk Assessment and enhance preventive controls • Additional L. monocytogenes product pathway simulation studies to evaluate variables in manufacture and distribution that can be used to provide guidance on specific control strategies • FDA and CDC will seek means for readily and objectively assessing the immune status of susceptible populations • Initiate research to determine the growth rate of L. monocytogenes in specific foods to provide information and guidance on safety-related date marking and practical means for consumers to control L. monocytogenes

19. In Conclusion This Action Plan is designed by FDA and CDC to meet an accelerated Healthy People 2010 goal to reduce Listeria monocytogenes illness by 50 percent by 2005.