Risk Assessment Modeling FILE 1
29 The framework of this risk assessment was to gather all the available literature on the subject and
to select all the literature that falls specifically into the scope of the risk assessment. The available information was then used, through statistical and probabilistic methods, to derive a
distribution of the variability of the parameter and to estimate the surrounding uncertainty of this estimated distribution. Whenever possible i.e. whenever more than one source was available,
no specific data or dataset was used.
The baseline models were modified to estimate the relative public health impacts of alternate interventions, practices, and conditions and the results of these modifications were expressed
relative to the baseline models.
Modeling was carried out using Analytica Professional 4.2 from Lumina Decision Systems Los Gatos, CA Lumina Decision Systems 2010. For quality assurance, each component of the
model was also programmed and tested using the R language Version 2.8 The R Development Core Team, Vienna, Austria R Development Core Team 2008. Variability and uncertainty
were evaluated separately using a Second-Order Monte Carlo simulation framework Frey 1992. Overall the model consisted of three modules: exposure assessment, hazard characterization, and
risk characterization Figure 2.
Figure 2: The 3 modules of the model.
The exposure assessment module contained a series of stages corresponding to the major stages in the process of producing, distributing, and consuming soft-ripened cheese. In particular,
Camembert cheese was used as an example of a soft-ripened cheese for several stages in the exposure assessment module. These are shown in Figure 3. Each stage might consist of one or
Hazard Characterization
- Dose Response -
Exposure assessment
- Listeria monocytogenes consumed -
Risk characterization
30 more steps during which the prevalence and level of L. monocytogenes might change. These
steps are described in detail in the following sections. Changes in input values or process parameters in the exposure assessment module were used to address alternate intervention or
process scenarios.
Figure 3: The 5 stages of the exposure assessment.
In addition to the individual steps, sub-routines were developed to describe basic processes Nauta 2008 that affect L. monocytogenes prevalence and levels in multiple steps. These
included microbial growth, microbial inactivation, environmental contamination, removal, and partitioning and mixing.
The hazard characterization module contained dose-response functions for each of the populations considered in this risk assessment. The assessment considered four populations, the
General non-susceptible population and three susceptible groups the Elderly, the Immunocompromised, and Pregnant woman in both the U.S. and Canada.
The risk characterization module combined the results of the exposure assessment for each population with the hazard characterization for that population to estimate risk. Risk was
expressed on a “per serving” basis because the lack of data on overall levels of cheese production particularly for small cheese makers and on possible differences in cheese source preference
among the different populations prevented developing integrated estimates of risk. The impacts of the changes evaluated in the different scenarios were expressed as relative risk compared to
baseline models.
The results of the risk assessment are discussed in detail in the sections 9 and 10.