A quantitative risk metric to support individual sanitary measure reviews in international trade.

In order for the United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) to make an equivalence determination for a foreign meat, poultry or egg products inspection procedure that differs from FSIS inspection procedures (an Individual Sanitary Measure or ISM), a country must demonstrate objectively that its food safety inspection system provides the same level of public health protection as the FSIS inspection system. To evaluate microbiological testing data that such countries may submit to this end, we present a possible risk metric to inform FSIS's assessment of whether products produced under an alternative inspection system in another country pose no greater consumer risk of foodborne illness than products produced under FSIS inspection. This metric requires evaluation of prevalence estimates of pathogen occurrence in products for the foreign country and the U.S. and determining what constitutes an unacceptable deviance of another country's prevalence from the U.S. prevalence, i.e., the margin of equivalence. We define the margin of equivalence as a multiple of the standard error of the U.S. prevalence estimate. Minimizing the margin of equivalence ensures the maximum public health protection for U.S. consumers, but an optimum choice must also avoid undue burden for quantitative data from alternative inspection systems in the foreign country. Across a wide range of U.S. prevalence levels and sample sizes, we determine margin of equivalence values that provide high confidence in conclusions as to whether or not the country's product poses no greater risk of foodborne illness from microbiological pathogens. These margins of equivalence can be used to inform FSIS's equivalence determination for an ISM request from a foreign country. Illustrative examples are used to support this definition of margin of equivalence. This approach is consistent with the World Trade Organization's concept of risk equivalence and is transparent and practical to apply in situations when FSIS makes an equivalence determination for an ISM requested by a foreign country.

Assessment of the Risk of Salmonellosis Linked to the Consumption of Liquid Egg Products Made from Internally Contaminated Shell Eggs Initially Stored at 65°F (18°C) Compared with Eggs Stored at 45°F (7°C).

ABSTRACT: According to the U.S. Food and Drug Administration's (FDA's) rule on "Prevention of Salmonella Enteritidis in Shell Eggs during Production, Storage, and Transportation," shell eggs intended for human consumption are required to be held or transported at or below 45°F (7.2°C) ambient temperature beginning 36 h after time of lay. Meanwhile, eggs in hatcheries are typically stored at a temperature of 65°F (18.3°C). Although most of those eggs are directed to incubators for hatching, excess eggs have the potential to be diverted for human consumption as egg products through the "breaker" market if these eggs are refrigerated in accordance with FDA's requirement. Combining risk assessment models developed by the U.S. Department of Agriculture's Food Safety and Inspection Service for shell eggs and for egg products, we quantified and compared Salmonella Enteritidis levels in eggs held at 65°F versus 45°F, Salmonella Enteritidis levels in the resulting egg products, and the risk of human salmonellosis from consumption of those egg products. For eggs stored 5 days at 65°F (following 36 h at 75°F [23.9°C] in the layer house), the mean level of Salmonella Enteritidis contamination is 30-fold higher than for eggs stored at 45°F. These increased levels of contamination lead to a 47-fold increase in the risk of salmonellosis from consumption of egg products made from these eggs, with some variation in the public health risk on the basis of the egg product type (e.g., whole egg versus whole egg with added sugar). Assuming that 7% of the liquid egg product supply originates from eggs stored at 65°F versus 45°F, this study estimates an additional burden of 3,562 cases of salmonellosis per year in the United States. A nominal range uncertainty analysis suggests that the relative increase in the risk linked to the storage of eggs at higher temperature estimated in this study is robust to the uncertainty surrounding the model parameters. The diversion of eggs from broiler production to human consumption under the current storage practices of 65°F (versus 45°F) would present a substantive overall increase in the risk of salmonellosis.

Occurrence of Listeria monocytogenes in Ready-to-Eat Meat and Poultry Product Verification Testing Samples from U.S. Department of Agriculture-Regulated Producing Establishments, 2005 through 2017.

ABSTRACT: Ready-to-eat (RTE) meat and poultry product samples collected between 2005 and 2017 from RTE-producing establishments for the U.S. Department of Agriculture, Food Safety and Inspection Service (FSIS) ALLRTE/RTEPROD_RAND (random) and RTE001/RTEPROD_RISK (risk-based) sampling projects were tested for Listeria monocytogenes (Lm). Data for 45,897 ALLRTE/RTEPROD_RAND samples collected from 3,607 distinct establishments and 112,347 RTE001/RTEPROD_RISK samples collected from 3,283 distinct establishments were analyzed for the presence of Lm. These data were also analyzed based upon the percentages of establishments with positive samples, annual production volume, sanitation control alternatives, geographic location, and season or month of sample collection. Results revealed low occurrence of Lm-positive samples from the random and risk-based sampling projects, with 152 (0.33%) positive samples for ALLRTE/RTEPROD_RAND and 403 (0.36%) positive samples for RTE001/RTEPROD_RISK. The percentage of positive samples significantly decreased over time, from about 0.7% in 2005 and 2006 to about 0.2% in 2017 (P < 0.05). From 2005 to 2017, 3.9% of establishments sampled under the ALLRTE/RTEPROD_RAND sampling project had at least one Lm-positive sample. Similarly, 10.0% of establishments sampled under the RTE001/RTEPROD_RISK sampling project had at least one positive sample. Samples positive for Lm were found in all geographic regions in all months. Thus, in 13 years of RTE product sampling in FSIS-regulated establishments (2005 through 2017), <0.4% of samples were positive for Lm in both risk-based and random sampling projects. The low prevalence of Lm in these products suggests that the combination of FSIS policies and industry practices may be effective for controlling Lm contamination. Information obtained from these sampling projects is relevant to the ongoing prevention of foodborne Lm illnesses from RTE meat and poultry products.

Food Safety Practices Linked with Proper Refrigerator Temperatures in Retail Delis.

Listeria monocytogenes (L. monocytogenes) causes the third highest number of foodborne illness deaths annually. L. monocytogenes contamination of sliced deli meats at the retail level is a significant contributing factor to L. monocytogenes illness. The Centers for Disease Control and Prevention's Environmental Health Specialists Network (EHS-Net) conducted a study to learn more about retail delis' practices concerning L. monocytogenes growth and cross-contamination prevention. This article presents data from this study on the frequency with which retail deli refrigerator temperatures exceed 41°F, the Food and Drug Administration (FDA)-recommended maximum temperature for ready-to-eat food requiring time and temperature control for safety (TCS) (such as retail deli meat). This provision was designed to control bacterial growth in TCS foods. This article also presents data on deli and staff characteristics related to the frequency with which retail delis refrigerator temperatures exceed 41°F. Data from observations of 445 refrigerators in 245 delis showed that in 17.1% of delis, at least one refrigerator was >41°F. We also found that refrigeration temperatures reported in this study were lower than those reported in a related 2007 study. Delis with more than one refrigerator, that lacked refrigerator temperature recording, and had a manager who had never been food safety certified had greater odds of having a refrigerator temperature >41°F. The data from this study suggest that retail temperature control is improving over time. They also identify a food safety gap: some delis have refrigerator temperatures that exceed 41°F. We also found that two food safety interventions were related to better refrigerated storage practices: kitchen manager certification and recording refrigerated storage temperatures. Regulatory food safety programs and the retail industry may wish to consider encouraging or requiring kitchen manager certification and recording refrigerated storage temperatures.

Listeria monocytogenes in Retail Delicatessens: An Interagency Risk Assessment-Risk Mitigations.

Cross-contamination, improper holding temperatures, and insufficient sanitary practices are known retail practices that may lead to product contamination and growth of Listeria monocytogenes. However, the relative importance of control options to mitigate the risk of invasive listeriosis from ready-to-eat (RTE) products sliced or prepared at retail is not well understood. This study illustrates the utility of a quantitative risk assessment model described in a first article of this series (Pouillot, R., D. Gallagher, J. Tang, K. Hoelzer, J. Kause, and S. B. Dennis, J. Food Prot. 78:134-145, 2015) to evaluate the public health impact associated with changes in retail deli practices and interventions. Twenty-two mitigation scenarios were modeled and evaluated under six different baseline conditions. These scenarios were related to sanitation, worker behavior, use of growth inhibitors, cross-contamination, storage temperature control, and reduction of the level of L. monocytogenes on incoming RTE food products. The mean risk per serving of RTE products obtained under these scenarios was then compared with the risk estimated in the baseline condition. Some risk mitigations had a consistent impact on the predicted listeriosis risk in all baseline conditions (e.g. presence or absence of growth inhibitor), whereas others were greatly dependent on the initial baseline conditions or practices in the deli (e.g. preslicing of products). Overall, the control of the bacterial growth and the control of contamination at its source were major factors of listeriosis risk in these settings. Although control of cross-contamination and continued sanitation were also important, the decrease in the predicted risk was not amenable to a simple solution. Findings from these predictive scenario analyses are intended to encourage improvements to retail food safety practices and mitigation strategies to control L. monocytogenes in RTE foods more effectively and to demonstrate the utility of quantitative risk assessment models to inform risk management decisions.

Listeria monocytogenes in Retail Delicatessens: an Interagency Risk Assessment-model and baseline results.

The Interagency Risk Assessment-Listeria monocytogenes (Lm) in Retail Delicatessens provides a scientific assessment of the risk of listeriosis associated with the consumption of ready-to-eat (RTE) foods commonly prepared and sold in the delicatessen (deli) of a retail food store. The quantitative risk assessment (QRA) model simulates the behavior of retail employees in a deli department and tracks the Lm potentially present in this environment and in the food. Bacterial growth, bacterial inactivation (following washing and sanitizing actions), and cross-contamination (from object to object, from food to object, or from object to food) are evaluated through a discrete event modeling approach. The QRA evaluates the risk per serving of deli-prepared RTE food for the susceptible and general population, using a dose-response model from the literature. This QRA considers six separate retail baseline conditions and provides information on the predicted risk of listeriosis for each. Among the baseline conditions considered, the model predicts that (i) retail delis without an environmental source of Lm (such as niches), retail delis without niches that do apply temperature control, and retail delis with niches that do apply temperature control lead to lower predicted risk of listeriosis relative to retail delis with niches and (ii) retail delis with incoming RTE foods that are contaminated with Lm lead to higher predicted risk of listeriosis, directly or through cross-contamination, whether the contaminated incoming product supports growth or not. The risk assessment predicts that listeriosis cases associated with retail delicatessens result from a sequence of key events: (i) the contaminated RTE food supports Lm growth; (ii) improper retail and/or consumer storage temperature or handling results in the growth of Lm on the RTE food; and (iii) the consumer of this RTE food is susceptible to listeriosis. The risk assessment model, therefore, predicts that cross-contamination with Lm at retail predominantly results in sporadic cases.

Listeria monocytogenes and Listeria spp. contamination patterns in retail delicatessen establishments in three U.S. states.

Postprocessing contamination in processing plants has historically been a significant source of Listeria monocytogenes in ready-to-eat delicatessen meats, and therefore a major cause of human listeriosis cases and outbreaks. Recent risk assessments suggest that a majority of human listeriosis cases linked to consumption of contaminated deli meats may be due to L. monocytogenes contamination that occurs at the retail level. To better understand the ecology and transmission of Listeria spp. in retail delicatessens, food and nonfood contact surfaces were tested for L. monocytogenes and other Listeria spp. in a longitudinal study conducted in 30 retail delis in three U.S. states. In phase I of the study, seven sponge samples were collected monthly for 3 months in 15 delis (5 delis per state) prior to start of daily operation; in phase II, 28 food contact and nonfood contact sites were sampled in each of 30 delis during daily operation for 6 months. Among the 314 samples collected during phase I, 6.8% were positive for L. monocytogenes. Among 4,503 samples collected during phase II, 9.5% were positive for L. monocytogenes; 9 of 30 delis showed low L. monocytogenes prevalence (<1%) for all surfaces. A total of 245 Listeria spp. isolates, including 184 Listeria innocua, 48 Listeria seeligeri, and 13 Listeria welshimeri were characterized. Pulsed-field gel electrophoresis (PFGE) was used to characterize 446 L. monocytogenes isolates. PFGE showed that for 12 of 30 delis, one or more PFGE types were isolated on at least three separate occasions, providing evidence for persistence of a given L. monocytogenes subtype in the delis. For some delis, PFGE patterns for isolates from nonfood contact surfaces were distinct from patterns for occasional food contact surface isolates, suggesting limited cross-contamination between these sites in some delis. This study provides longitudinal data on L. monocytogenes contamination patterns in retail delis, which should facilitate further development of control strategies in retail delis.

Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

Characterizing uncertainty when evaluating risk management metrics: risk assessment modeling of Listeria monocytogenes contamination in ready-to-eat deli meats.

This report illustrates how the uncertainty about food safety metrics may influence the selection of a performance objective (PO). To accomplish this goal, we developed a model concerning Listeria monocytogenes in ready-to-eat (RTE) deli meats. This application used a second order Monte Carlo model that simulates L. monocytogenes concentrations through a series of steps: the food-processing establishment, transport, retail, the consumer's home and consumption. The model accounted for growth inhibitor use, retail cross contamination, and applied an FAO/WHO dose response model for evaluating the probability of illness. An appropriate level of protection (ALOP) risk metric was selected as the average risk of illness per serving across all consumed servings-per-annum and the model was used to solve for the corresponding performance objective (PO) risk metric as the maximum allowable L. monocytogenes concentration (cfu/g) at the processing establishment where regulatory monitoring would occur. Given uncertainty about model inputs, an uncertainty distribution of the PO was estimated. Additionally, we considered how RTE deli meats contaminated at levels above the PO would be handled by the industry using three alternative approaches. Points on the PO distribution represent the probability that - if the industry complies with a particular PO - the resulting risk-per-serving is less than or equal to the target ALOP. For example, assuming (1) a target ALOP of -6.41 log10 risk of illness per serving, (2) industry concentrations above the PO that are re-distributed throughout the remaining concentration distribution and (3) no dose response uncertainty, establishment PO's of -4.98 and -4.39 log10 cfu/g would be required for 90% and 75% confidence that the target ALOP is met, respectively. The PO concentrations from this example scenario are more stringent than the current typical monitoring level of an absence in 25 g (i.e., -1.40 log10 cfu/g) or a stricter criteria of absence in 125 g (i.e., -2.1 log10 cfu/g). This example, and others, demonstrates that a PO for L. monocytogenes would be far below any current monitoring capabilities. Furthermore, this work highlights the demands placed on risk managers and risk assessors when applying uncertain risk models to the current risk metric framework.

Tracking cross-contamination transfer dynamics at a mock retail deli market using GloGerm.

Ready-to-eat (RTE) deli meats are considered a food at high risk for causing foodborne illness. Deli meats are listed as the highest risk RTE food vehicle for Listeria monocytogenes. Cross-contamination in the retail deli market may contribute to spread of pathogens to deli meats. Understanding potential cross-contamination pathways is essential for reducing the risk of contaminating various products. The objective of this study was to track cross-contamination pathways through a mock retail deli market using an abiotic surrogate, GloGerm, to visually represent how pathogens may spread through the deli environment via direct contact with food surfaces. Six contamination origination sites (slicer blade, meat chub, floor drain, preparation table, employee's glove, and employee's hands) were evaluated separately. Each site was inoculated with 20 ml of GloGerm, and a series of standard deli operations were completed (approximately 10 min of work). Photographs were then taken under UV illumination to visualize spread of GloGerm throughout the deli. A sensory panel evaluated the levels of contamination on the resulting contaminated surfaces. Five of the six contamination origination sites were associated with transfer of GloGerm to the deli case door handle, slicer blade, meat chub, preparation table, and the employee's gloves. Additional locations became contaminated (i.e., deli case shelf, prep table sink, and glove box), but this contamination was not consistent across all trials. Contamination did not spread from the floor drain to any food contact surfaces. The findings of this study reinforce the need for consistent equipment cleaning and food safety practices among deli workers to minimize cross-contamination.

Estimation of Listeria monocytogenes transfer coefficients and efficacy of bacterial removal through cleaning and sanitation.

Listeria monocytogenes is readily found in the environment of retail deli establishments and can occasionally contaminate food handled in these establishments. Here we synthesize the available scientific evidence to derive probability distributions and mathematical models of bacterial transfers between environmental surfaces and foods, including those during slicing of food, and of bacterial removal during cleaning and sanitizing (models available at www.foodrisk.org). Transfer coefficients varied considerably by surface type, and after log(10) transformation were best described by normal distributions with means ranging from -0.29 to -4.96 and standard deviations that ranged from 0.07 to 1.39. 'Transfer coefficients' during slicing were best described by a truncated logistic distribution with location 0.07 and scale 0.03. In the absence of protein residues, mean log inactivation indicated a greater than 5 log(10) reduction for sanitization with hypochlorite (mean: 6.5 log(10); 95% confidence interval (CI): 5.0-8.1 log(10)) and quaternary ammonium compounds (mean: 5.5 log(10); 95% CI: 3.6-7.3 log(10)), but in the presence of protein residues efficacy reduced dramatically for hypochlorite (mean: 3.8 log(10); 95% CI: 2.1-5.4 log(10)) as well as quaternary ammonium compounds (mean: 4.4log(10); 95% CI: 2.5-6.4 log(10)). Overall, transfer coefficients are therefore low, even though cross-contamination can be extremely efficient under certain conditions. Dozens of food items may consequently be contaminated from a single contaminated slicer blade, albeit at low concentrations. Correctly performed sanitizing efficiently reduces L. monocytogenes contamination in the environment and therefore limits cross-contamination, even though sanitization is only performed a few times per day. However, under unfavorable conditions reductions in bacterial concentration may be far below 5 log(10). The probability distributions and mathematical models derived here can be used to evaluate L. monocytogenes cross-contamination dynamics in environments where foods are handled, and to assess the potential impact of different intervention strategies.

A comparative risk assessment for Listeria monocytogenes in prepackaged versus retail-sliced deli meat.

Deli meat was ranked as the highest-risk ready-to-eat food vehicle of Listeria monocytogenes within the 2003 U.S. Food and Drug Administration and U.S. Department of Agriculture, Food Safety and Inspection Service risk assessment. The comparative risk of L. monocytogenes in retail-sliced versus prepackaged deli meats was evaluated with a modified version of this model. Other research has found that retail-sliced deli meats have both higher prevalence and levels of L. monocytogenes than have product sliced and packaged at the manufacturer level. The updated risk assessment model considered slicing location as well as the use of growth inhibitors. The per annum comparative risk ratio for the number of deaths from retail-sliced versus prepackaged deli meats was found to be 4.89, and the per-serving comparative risk ratio was 4.27. There was a significant interaction between the use of growth inhibitors and slicing location. Almost 70% of the estimated deaths occurred from retail-sliced product that did not possess a growth inhibitor. A sensitivity analysis, assessing the effect of the model's consumer storage time and shelf life assumptions, found that even if retail-sliced deli meats were stored for a quarter of the time prepackaged deli meats were stored, retail-sliced product is 1.7 times more likely to result in death from listeriosis. Sensitivity analysis also showed that the shelf life assumption had little effect on the comparative risk ratio.

Application of quantitative microbial risk assessments for estimation of risk management metrics: Clostridium perfringens in ready-to-eat and partially cooked meat and poultry products as an example.

The U.S. Department of Agriculture, Food Safety and Inspection Service is exploring quantitative risk assessment methodologies to incorporate the use of the Codex Alimentarius' newly adopted risk management metrics (e.g., food safety objectives and performance objectives). It is suggested that use of these metrics would more closely tie the results of quantitative microbial risk assessments (QMRAs) to public health outcomes. By estimating the food safety objective (the maximum frequency and/or concentration of a hazard in a food at the time of consumption) and the performance objective (the maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption), risk managers will have a better understanding of the appropriate level of protection (ALOP) from microbial hazards for public health protection. We here demonstrate a general methodology that allows identification of an ALOP and evaluation of corresponding metrics at appropriate points in the food chain. It requires a two-dimensional probabilistic risk assessment, the example used being the Monte Carlo QMRA for Clostridium perfringens in ready-to eat and partially cooked meat and poultry products, with minor modifications to evaluate and abstract required measures. For demonstration purposes, the QMRA model was applied specifically to hot dogs produced and consumed in the United States. Evaluation of the cumulative uncertainty distribution for illness rate allows a specification of an ALOP that, with defined confidence, corresponds to current industry practices.

Risk assessment for Clostridium perfringens in ready-to-eat and partially cooked meat and poultry products.

An assessment of the risk of illness associated with Clostridium perfringens in ready-to-eat and partially cooked meat and poultry products was completed to estimate the effect on the annual frequency of illnesses of changing the allowed maximal 1-log growth of C. perfringens during stabilization (cooling after the manufacturing heat step). The exposure assessment modeled stabilization, storage, and consumer preparation such as reheating and hot-holding. The model predicted that assuming a 10- or 100-fold increase from the assumed 1-log (maximal allowable) growth of C. perfringens results in a 1.2- or 1.6-fold increase of C. perfringens-caused illnesses, respectively, at the median of the uncertainty distribution. Improper retail and consumer refrigeration accounted for approximately 90% of the 79,000 C. perfringens illnesses predicted by the model at 1-log growth during stabilization. Improper hot-holding accounted for 8% of predicted illnesses, although model limitations imply that this is an underestimate. Stabilization accounted for less than 1% of illnesses. Efforts to reduce illnesses from C. perfringens in ready-to-eat and partially cooked meat and poultry products should focus on retail and consumer storage and preparation methods.

Evaluating the effectiveness of pasteurization for reducing human illnesses from Salmonella spp. in egg products: results of a quantitative risk assessment.

As part of the process for developing risk-based performance standards for egg product processing, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) undertook a quantitative microbial risk assessment for Salmonella spp. in pasteurized egg products. The assessment was designed to assist risk managers in evaluating egg handling and pasteurization performance standards for reducing the likelihood of Salmonella in pasteurized egg products and the subsequent risk to human health. The following seven pasteurized liquid egg product formulations were included in the risk assessment model, with the value in parentheses indicating the estimated annual number of human illnesses from Salmonella from each: egg white (2636), whole egg (1763), egg yolk (708), whole egg with 10% salt (407), whole egg with 10% sugar (0), egg yolk with 10% salt (11), and egg yolk with 10% sugar (0). Increased levels of pasteurization were predicted to be highly effective mitigations for reducing the number of illnesses. For example, if all egg white products were pasteurized for a 6-log(10) reduction of Salmonella, the estimated annual number of illnesses from these products would be reduced from 2636 to 270. The risk assessment identified several data gaps and research needs, including a quantitative study of cross-contamination during egg product processing and characterization of egg storage times and temperatures (i) on farms and in homes, (ii) for eggs produced off-line, and (iii) for egg products at retail. Pasteurized egg products are a relatively safe food; however, findings from this study suggest increased pasteurization can make them safer.

Overview and summary of the Food Safety and Inspection Service risk assessment for Salmonella enteritidis in shell eggs, October 2005.

In 1998, the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) and the Food and Drug Administration completed a risk assessment that indicated multiple interventions along the farm-to-table chain were needed to reduce the risk of human illness from Salmonella Enteritidis in shell eggs. Based on newly available data and improved modeling techniques, FSIS completed an updated risk assessment to examine the effect of pasteurization and refrigeration on reducing human illnesses from S. Enteritidis in shell eggs. The risk assessment model was written in Visual Basic for Applications (Microsoft, Redmond, WA) and run using Monte Carlo methods. The model estimated that if all shell eggs produced in the United States were pasteurized for a 3-log10 reduction of S. Enteritidis, the annual number of illnesses from S. Enteritidis in eggs would decrease from approximately 130,000 to 40,000. Pasteurization for a 5-log10 reduction of S. Enteritidis was estimated to reduce the annual number of illnesses to 19,000. The model also estimated that if all eggs produced in the United States were stored and held at 7.2 degrees C within 12 hours of lay, the annual number of illnesses from S. Enteritidis in eggs would decrease from 130,000 to 28,000. As a result, rapid cooling and pasteurization of shell eggs were predicted to be highly effective mitigations for reducing illnesses from consumption of S. Enteritidis in shell eggs.