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Frozen foods do not support the growth of Listeria monocytogenes (LM) and should be handled appropriately for safety. However, consumer trends regarding preparation of some frozen foods may contribute to the risk of foodborne listeriosis, specifically when cooking instructions are not followed and frozen products are instead added directly to smoothies or salads. A quantitative microbial risk assessment model FFLLoRA (Frozen Food Listeria Lot Risk Assessment) was developed to assess the lot-level listeriosis risk due to LM contamination in frozen vegetables consumed as a ready-to-eat food. The model was designed to estimate listeriosis risk per serving and the number of illnesses per production lot of frozen vegetables contaminated with LM, considering individual facility factors such as lot size, prevalence of LM contamination, and consumer handling prior to consumption. A production lot of 1 million packages with 10 servings each was assumed. When at least half of the servings were cooked prior to consumption, the median risk of invasive listeriosis per serving in both the general and susceptible population was <1.0 × 10⁻¹⁶ with the median (5th, 95th percentiles) predicted number of illnesses per lot as 0 (0, 0) and 0 (0, 1) under the exponential and Weibull-gamma dose-response functions, respectively. In scenarios in which all servings are consumed as ready-to-eat, the median predicted risk per serving was 1.8 × 10⁻¹³ and 7.8 × 10⁻¹² in the general and susceptible populations, respectively. The median (5th, 95th percentile) number of illnesses was 0 (0, 0) and 0 (0, 6) for the exponential and Weibull-Gamma models, respectively. Classification tree analysis highlighted initial concentration of LM in the lot, temperature at which the product is thawed, and whether a serving is cooked as main predictors for illness from a lot. Overall, the FFLLoRA provides frozen food manufacturers with a tool to assess LM contamination and consumer behavior when managing rare and/or minimal contamination events in frozen foods.

• A tool for frozen food manufacturers to assess listeriosis risk was developed.

• Scenarios of low-level L. monocytogenes in frozen vegetables did not typically result in illness.

• Listeriosis cases depended on model inputs related to consumer handling and initial concentration.

• Scenarios of more testing increased the probability of finding a contaminated lot and reduced risk.

Listeria monocytogenes is a hardy psychrotrophic pathogen that has been linked to several cheese-related outbreaks in the United States, including a recent outbreak in which a fresh cheese (queso fresco) was implicated. The purpose of this study was to develop primary, secondary, and tertiary predictive models for the growth of L. monocytogenes in queso fresco and to validate these models using nonisothermal time and temperature profiles. A mixture of five strains of L. monocytogenes was used to inoculate pasteurized whole milk to prepare queso fresco. Ten grams of each fresh cheese sample was vacuum packaged and stored at 4, 10, 15, 20, 25, and 30°C. From samples at each storage temperature, subsamples were removed at various times and diluted in 0.1% peptone water, and bacteria were enumerated on Listeria selective agar. Growth data from each temperature were fitted using the Baranyi model as the primary model and the Ratkowsky model as the secondary model. Models were then validated using nonisothermal conditions. The Baranyi model was fitted to the isothermal growth data with acceptable goodness of fit statistics (R² = 0.928; root mean square error = 0.317). The Ratkowsky square root model was fitted to the specific growth rates at different temperatures (R² = 0.975). The tertiary model developed from these models was validated using the growth data with two nonisothermal time and temperature profiles (4 to 20°C for 19 days and 15 to 30°C for 11 days). Data for these two profiles were compared with the model prediction using an acceptable prediction zone analysis; >70% of the growth observations were within the acceptable prediction zone (between −1.0 and 0.5 log CFU/g). The model developed in this study will be useful for estimating the growth of L. monocytogenes in queso fresco. These predictions will help in estimation of the risk of listeriosis from queso fresco under extended storage and temperature abuse conditions.

• Growth of L. monocytogenes was examined in queso fresco at constant temperatures.

• A positive correlation was found between temperature and growth rate.

• A tertiary model was developed to predict growth under nonisothermal conditions.

• The acceptable prediction zone analysis suggests that the tertiary model was acceptable.