List of Tables and Figures

Summary Table 1. Relative Risk Ranking and Predicted Median Cases of Listeriosis for the Total United States Population on a per Serving and per Annum Basis x

Table II-1. Incidence of Foodborne Pathogens in the United States

Table II-2. Reports of Outbreaks of Listerial Gastroenteritis

Table II-3. Isolation of Listeria Monocytogenes In Food Specimens Collected from the Refrigerators of Patients with Listeriosis

Table II-4. Outbreaks of Listeriosis in the United States (1970-2002) with Known Food Vehicle(s)

Table II-5. Outbreaks of Listeriosis Outside the United States (1970-2000) with Known Food Vehicle

Table II-6. A Comparative Ranking of Types of Food Vehicles by Outbreaks and Cases with Combined United States and International Outbreak Data

Table III-1. Food Categories Used in this Listeria monocytogenes Risk Assessment

Table III-2. Estimates of the Total Number of Annual Servings of Foods Consumed in the United States by Population and Food Category

Table III-3. Percentiles of Serving Size Distributions for Each Food Category

Table III-4. Listeria monocytogenes Contamination: Numbers of Qualitative and Quantitative Studies and Samples

Table III-5. Variation in Post-Retail Storage Times Assigned to the Food Categories

Table III-6. Refrigerated Storage Times for Frankfurters and Deli Meats in the Home

Table III-7. Frequency Distribution of Home Refrigerator Temperatures

Table III-8. Mean Exponential Listeria monocytogenes Growth Rates and Total Number of Samples From Growth Rate Studies for Each Food Category

Table III-9. Selected Studies Used to Characterize the Distribution of Listeria monocytogenes in Food at Retail

Table III-10. Standard Deviation Ranges for Each Food Category

Table III-11. Prevalence Reduction Ratios for Listeria monocytogenes Using Study Age

Table III-12. Estimated Storage Temperature and Duration Between Manufacture and Retail and Predicted Median Growth

Table III-13. Prevalence Studies of Listeria monocytogenes in Smoked Seafood

Table III-14. Modeled Percentage Distribution of Food Servings Contaminated with Listeria monocytogenes at Retail

Table III-15. Cumulative Distribution of the Reduction (log₁₀) of Listeria monocytogenes in Reheated Frankfurters

Table III-16. Modeled Percentage Distribution of Food Servings Contaminated with Listeria monocytogenes at Time of Consumption

Table III-17. Number of Servings of Food per Year Containing Various Levels of Listeria monocytogenes

Table IV-1. Characteristics of This Listeria monocytogenes Risk Assessment (FDA/FSIS) and Previously Conducted Listeria monocytogenes Risk Assessments that Contain Dose-Response Models for Listeriosis

Table IV-2. Parameters for the Statistical Distribution Models Used in the Probability Tree for the Mouse Dose-Frequency Relationship

Table IV-3. LD₅₀ Values for Various Listeria monocytogenes Strains Following Intraperitoneal Injection in Normal Mice

Table IV-4. Effect of Route of Listeria monocytogenes Administration (Intragastric vs. Intraperitoneal) on Mouse LD₅₀

Table IV-5. Parameters for the Statistical Distribution Models Used in the Probability Tree for Variation in Strain Virulence

Table IV-6. Model Output for Listeria monocytogenes Strain Virulence

Table IV-7. Parameters for Variability Distributions for Host Susceptibility for Listeriosis

Table IV-8. Model Output for Variability Adjustment Factors for Host Susceptibility to Listeriosis.

Table IV-9. Model-Dependence of the Listeria monocytogenes Dose-Response Scaling Factor Ranges for the Three Subpopulations

Table IV-10. Number of Listeria monocytogenes Isolates by Patient Age and Year of Occurrence

Table IV-11. Reported and National Annual Projections for Severe Listeriosis, Based of FoodNet Reports

Table IV-12. Dose-Response with Variable Listeria monocytogenes Strain Virulence for Three Age-Based Subpopulations

Table V-1. Estimated Number of Cases of Listeriosis per Serving for each Food Category and Subpopulation

Table V-2. Predicted Relative Risk Rankings For Listeriosis Among Food Categories for Three Age-Based Subpopulations and the United States Total Population Using Median Estimates of Predicted Relative Risks for Listeriosis on a per Serving Basis

Table V-3. Estimated Number of Cases of Listeriosis per Annum for each Food Category and Subpopulation

Table V-4. Predicted Relative Risk Rankings for Listeriosis Among Food Categories for Three Age-Based Subpopulations and the United States Total Population Using Median Estimates of Relative Predicted Risks for Listeriosis on a per Annum Basis

Table V-5a. Criteria Used to Designate Parameter Ranges for Listeria monocytogenes Among the Food Categories

Table V-5b. Summary of Data Used to Model Listeria monocytogenes Exposure for Each Food Relative to Other Food Categories

Table V-6. Relative Risk Ranking and Predicted Median Cases of Listeriosis for the Total United States Population on a per Serving and per Annum Basis

Table VI-1. Estimated Reduction of Cases of Listeriosis from Limits on Refrigeration Temperatures

Table VI-2. Impact of Home Refrigerator Storage Times on the Number of Predicted Cases of Listeriosis Attributed to Smoked Seafood for the Elderly Subpopulation

Table VI-3. Scenario testing: Reducing the Estimated Consumption of Unreheated Frankfurters

Table VI-4. Comparison of Baseline and a High Prevalence Scenerio Risk per Serving for Fresh Soft Cheese for Two Subpopulations

Table VI-5. Impact of Excluding Non-U.S. and Chocolate Milk from the Pasteurized Fluid Milk Food Category on the Number of Cases of Listeriosis per Serving Basis

Table VI-6. Impact of Excluding Non-U.S. and Chocolate Milk from the Pasteurized Fluid Milk Food Category on the Number of Cases of Listeriosis per Annum Basis

Table VII-1. Results of Cluster Analysis at the 0.1 Level

Summary Figure 1. Two-Dimensional Matrix of Food Categories Based on Cluster Analysis of Predicted per Serving and per Annum Relative Rankings

Figure I-1. Overview of Listeria monocytogenes Risk Assessment Document

Figure III-1. Components of the Exposure Assessment Model

Figure III-2. Example of the Contamination Curve for a Typical Food Category Showing Frequencies of Detectable and Nondetectable Samples

Figure III-3. A Lognormal Distribution for Listeria monocytogenes in Smoked Seafood

Figure III-4. Modeled Contamination Data for Smoked Seafood Food Category

Figure III-5. Modeled Distribution of Listeria monocytogenes Contamination Levels in Food Servings at Time of Retail

Figure III-6. Example of a Modified BetaPert Distribution

Figure III-7. Storage Time Distribution for Frankfurters and Deli Meats

Figure III-8. Three Dimensional Graph of the Modeled Distribution of Listeria monocytogenes Levels of Contamination at the Time of Consumption for the Food Categories

Figure IV-1. Components of the Dose-Response Model

Figure IV-2. Listeria monocytogenes Dose vs. Mortality in Mice

Figure IV-3. Dose vs. Frequency of Infection in Mice

Figure IV-4. Variation (Cumulative Frequency) of Listeria monocytogenes Strain Virulences: Nine Distributions

Figure IV-5. 1999 FoodNet Estimates of Listeriosis Incidence, by Age

Figure IV-6. Listeria monocytogenes Dose-Response for Mortality with Variable Strain Virulence for the Intermediate-Age Subpopulation

Figure IV-7. Listeria monocytogenes Dose-Response for Mortality with Variable Strain Virulence for the Neonatal Subpopulation

Figure IV-8. Listeria monocytogenes Dose-Response for Mortality with Variable Strain Virulence for the Elderly

Figure IV-9. Dose Frequency Function for Elderly Population with a Single Strain of Unknown Virulence

Figure V-1. Components of the Risk Characterization Model

Figure V-2. Predicted Cases of Listeriosis (log scale) Associated with Food Categories for the Total United States Population on a per Serving Basis

Figure V-3. Predicted Cases of Listeriosis (log scale) Associated with Food Categories for the Total United States Population on a per Annum Basis

Figure V-4a. Rankings of Total Predicted Listeriosis Cases per Serving for Smoked Seafood

Figure V-4b. Rankings of Total Predicted Listeriosis Cases per Annum for Smoked Seafood

Figure V-5a. Rankings of Total Predicted Listeriosis Cases per Serving for Raw Seafood

Figure V-5b. Rankings of Total Predicted Listeriosis Cases per Annum for Raw Seafood

Figure V-6a. Rankings of Total Predicted Listeriosis Cases per Serving for Preserved Fish

Figure V-6b. Rankings of Total Predicted Listeriosis Cases per Annum for Preserved Fish

Figure V-7a. Rankings of Total Predicted Listeriosis Cases per Serving for Cooked Ready-to-Eat Crustaceans

Figure V-7b. Rankings of Total Predicted Listeriosis Cases per Annum for Cooked Ready-to-Eat Crustaceans

Figure V-8a. Rankings of Total Predicted Listeriosis Cases per Serving for Vegetables

Figure V-8b. Rankings of Total Predicted Listeriosis Cases per Annum for Vegetables

Figure V-9a. Rankings of Total Predicted Listeriosis Cases per Serving for Fruits

Figure V-9b. Rankings of Total Predicted Listeriosis Cases per Annum for Fruits

Figure V-10a. Rankings of Total Predicted Listeriosis Cases per Serving for Fresh Soft Cheese.

Figure V-10b. Rankings of Total Predicted Listeriosis Cases per Annum for Fresh Soft Cheese.

Figure V-11a. Rankings of Total Predicted Listeriosis Cases per Serving for Soft Unripened Cheese

Figure V-11b. Rankings of Total Predicted Listeriosis Cases per Annum for Soft Unripened Cheese

Figure V-12a. Rankings of Total Predicted Listeriosis Cases per Serving for Soft Ripened Cheese.

Figure V-12b. Rankings of Total Predicted Listeriosis Cases per Annum for Soft Ripened Cheese.

Figure V-13a. Rankings of Total Predicted Listeriosis Cases per Serving for Semi-soft Cheese.

Figure V-13b. Rankings of Total Predicted Listeriosis Cases per Annum for Semi-soft Cheese.

Figure V-14a. Rankings of Total Predicted Listeriosis Cases per Serving for Hard Cheese

Figure V-14b. Rankings of Total Predicted Listeriosis Cases per Annum for Hard Cheese

Figure V-15a. Rankings of Total Predicted Listeriosis Cases per Serving for Processed Cheese.

Figure V-15b. Rankings of Total Predicted Listeriosis Cases per Annum for Processed Cheese

Figure V-16a. Rankings of Total Predicted Listeriosis Cases per Serving for Pasteurized Fluid Milk

Figure V-16b. Rankings of Total Predicted Listeriosis Cases per Annum for Pasteurized Fluid Milk

Figure V-17a. Rankings of Total Predicted Listeriosis Cases per Serving for Unpasteurized Fluid Milk

Figure V-17b. Rankings of Total Predicted Listeriosis Cases per Annum for Unpasteurized Fluid Milk

Figure V-18a. Rankings of Total Predicted Listeriosis Cases per Serving for Ice Cream and Frozen Dairy Products

Figure V-18b. Rankings of Total Predicted Listeriosis Cases per Annum for Ice Cream and Frozen Dairy Products

Figure V-19a. Rankings of Total Predicted Listeriosis Cases per Serving for Cultured Milk Products

Figure V-19b. Rankings of Total Predicted Listeriosis Cases per Annum for Cultured Milk Products

Figure V-20a. Rankings of Total Predicted Listeriosis Cases per Serving for High Fat and Other Dairy Products

Figure V-20b. Rankings of Total Predicted Listeriosis Cases per Annum for High Fat and Other Dairy Products

Figure V-21a. Rankings of Total Predicted Listeriosis Cases per Serving for Frankfurters (Reheated)

Figure V-21b. Rankings of Total Predicted Listeriosis Cases per Annum for Frankfurters (Reheated)

Figure V-22a. Rankings of Total Predicted Listeriosis Cases per Serving for Frankfurters (Not Reheated)

Figure V-22b. Rankings of Total Predicted Listeriosis Cases per Annum for Frankfurters (Not Reheated)

Figure V-23a. Rankings of Total Predicted Listeriosis Cases per Serving for Dry/Semi-Dry Fermented Sausages

Figure V-23b. Rankings of Total Predicted Listeriosis Cases per Annum for Dry/Semi-Dry Fermented Sausages

Figure V-24a. Rankings of Total Predicted Listeriosis Cases per Serving for Deli Meats

Figure V-24b. Rankings of Total Predicted Listeriosis Cases per Annum for Deli Meats

Figure V-25a. Rankings of Total Predicted Listeriosis Cases per Serving for Pâté and Meat Spreads

Figure V-25b. Rankings of Total Predicted Listeriosis Cases per Annum for Pâté and Meat Spreads

Figure V-26a. Rankings of Total Predicted Listeriosis Cases per Serving for Deli-type Salads

Figure V-26b. Rankings of Total Predicted Listeriosis Cases per Annum for Deli-type Salads.

Figure VI-1. Predicted Annual Mortality in the Elderly Population Attributable to Deli Meat as a Function of Maximum Storage Temperaure

Figure VI-2. Predicted Annual Mortality in the Elderly Population Attributable to Pasteurized Milk as a Function of Maximum Storage Temperaure

Figure VI-3. Predicted Annual Mortality in the Elderly Subpopulation Attributible to Deli Meats as a Function of Maximum Storage Time

Figure VI-4. Predicted Annual Mortality in the Elderly Subpopulation Attributible to Pasteurized Milk as a Function of Maximum Storage Time

Figure VI-5. Predicted Annual Mortality in the Elderly Subpopulation Attributible to Deli Meats as a Function of Maximum Storage Time and Maximum Storage Temperature

Figure VI-6. Cases of Listeriosis (per serving basis) for the Elderly Population as a Function of Listeria monocytogenes Concentration at Consumption in Deli Meats

Figure VI-7. Reduction of Predicted Annual Mortality in the Elderly Subpopulation Attributible to Deli Meats as a Function of Log Kill Achieved by the Inclusion of a Lethal Intervention Prior to Retail

Figure VI-8. Predicted Mortality per Serving for the Elderly Subpopulation When Specific Concentrations of Listeria monocytogenes in Deli Meats at Retail are Allowed to Grow Before Consumption

Figure VI-9. Cases of Listeriosis (per serving basis) for the Elderly Subpopulation as a Function of Listeria monocytogenes Concentration at Consumption for Deli Meat

Figure VI-10. Cases of Listeriosis (per serving basis) for the Neonatal Subpopulation as a Function of Listeria monocytogenes Concentration at Retail for Deli Meat

Figure VI-11. Cases of Listeriosis (per serving basis) for Elderly Subpopulation as a Function of Listeria monocytogenes Concentration at Retail for Hard Cheese

Figure VII-1. Two-Dimensional Matrix of Food Categories Based on Cluster Analysis of Predicted per Serving and per Annum Relative Rankings