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Home -> Help -> What's New in FDA-iRISK 5.0

Risk Scenarios

  • Multifood models with pre-run process models for concentration
  • Expanded and more flexible approach to defining diets
  • Added table views for visualization charts
  • Result tab on the Edit Risk Scenario page showing list of reports, summary of risk estimates, and options for visualization
  • Visualization of intermediate and final results for scenarios
  • Sensitivity analysis for chronic multi-food, multi-hazard scenarios

Consumption Models

  • Import chronic multifood consumption models
  • Chronic multifood consumption models parameterized by consumers-only distribution and percentage of consumers in the distribution for per capita distribution
  • Correlation of consumption across life stages for chronic multi-food consumption models

Process Models

  • Import microbial sampling plan OC curve from FDA-OC App
  • Added links to Notes for Predictive Models on the Edit Process Stage page
  • Distribution of microbial concentrations in contaminated products across process stages visualization for single food, microbial scenarios

User Interface Experience

  • Copy food feature enhanced to allow copies between repositories
  • Copy hazard feature enhanced to allow copies between repositories
  • Copy process model feature enhanced to allow copies between repositories

Notes

  • Add references to notes
  • Add images to notes

Predictive Microbiology Models

  • Import ComBase thermal inactivation models
  • Import ComBase non-thermal survival models
  • Import ComBase Salmonella in egg models
  • Import ComBase record growth and inactivation model fits
  • Import ComBase DMFit growth and inactivation model fits
  • Import ComBase Broth Model predicted growth
  • Import ComBase Perfringens Predictor predicted growth
  • Growth by Model process stages no longer require a temperature distribution when applying imported ComBase models

Sensitivity Analysis

  • Exclude repeated scenario details in sensitivity analysis risk estimate reports

Features Added in FDA-iRISK 4.2

Process Models

  • Concentration threshold exceedance process type for acute and chronic scenarios

Risk Scenarios

  • Lifetime Daily Average Dose (LADD) Exceedance feature for chronic, single food scenarios
  • Compute risk per person based on servings per year per person distributions for acute microbial scenarios
  • Sensitivity analysis now available in most scenario types, including multi-food and exposure only
  • Enhanced error messaging on sensitivity analysis tab

Predictive Microbiology Models

  • Baranyi-Roberts primary growth model which accepts parameters from DMFit at combase.errc.ars.usda.gov

Dose Response Models

  • APROBA dose response model now available for chronic chemical scenarios

Reports

  • Empirical and Chance parameter definitions moved to an appendix for a more compact scenario summary in Risk Estimates and Scenario Ranking reports

New Distribution Options

  • Laplace distribution
  • Lognormal distribution defined with median

Features Added in FDA-iRISK 4.1

Process Models

  • Import multiple parameter set initial conditions for microbial process models
  • Input linked uncertainty distributions for initial conditions for microbial process models

Risk Scenarios

  • Run a risk ranking report directly from the edit risk scenario page
  • Streamlined sensitivity analysis parameterization for supported scenario types
  • View all scenario model elements on the sensitivity analysis tab for supported scenario types
  • Direct link to model element edit page on the sensitivity analysis tab for supported scenario types

Predictive Microbiology Models

  • Import empirical growth and inactivation curves/models
  • New secondary growth model
  • New secondary lag model
  • Most secondary models now support distributions and uncertainty for model parameters

Dose Response Models

  • Import Empirical dose response models from text or Excel files

Reports

  • Export chronic chemical exposure results to Excel

Features Added in FDA-iRISK 4.0

2D Monte Carlo Simulation

  • Explicitly include probabilistic uncertainty and variability as separate dimensions (2D Monte Carlo Simulation)
  • Define uncertainty for most model parameters
  • Specify the settings used for variability and uncertainty simulations, including convergence criteria

Risk Scenarios

  • Create a multi-food scenario to capture chronic exposure of the consumer to a hazard found in multiple foods
  • Perform risk-risk and risk-benefit analysis with multi-hazard, multi-food chronic scenarios
  • Compare risks from chronic hazards among consumers with different dietary patterns
  • Improved parameter validation
  • QALY health metric now available

Sensitivity Analysis

  • New multi-parameter sensitivity analysis design
  • Specify parameters for multiple parameters simultaneously
  • Sensitivity analysis settings now saved with scenario

Process Models

  • Incorporate predictive models for microbial growth and inactivation
  • Parallel process models for microbial hazards
  • Linked process model to different downstream process models
  • Microbial toxin process models (using linked models)
  • Sampling process type
  • Cross contamination (addition) by transfer rate process type
  • Non-log distributions for microbial concentrations and counts
  • Define unit size as a distribution

Dose Response Models

  • Create custom dose response models with the empirical dose response model
  • Chronic monotonically decreasing dose response to evaluate health benefits
  • Define uncertainty on parameters separately or as linked sets
  • Import dose response models from shared library

Consumption Models

  • Multi-food consumption models
  • Populations groups renamed to lifestages for chronic consumption models
  • Import consumption models from shared library

Reports

  • Combine scenarios from different repositories in the same report
  • Option to rank by exposure
  • Simulation job notifications
  • Convergence report
  • Edit title and abstract for completed reports

UI Experience

  • Centralized notes for model elements
  • Link back to scenarios from the reports page for quick review
  • Improved charts

Distributions

  • Import empirical distributions
  • Specify Uniform and Triangular distributions using 5th and 95th percentiles

Features Added in FDA-iRISK 2.0

Process Models

  • Maximum Population Density (MPD) now included for microbial models
  • "Increase by Addition" now handles rare event additions
  • Variability distributions now include: Beta, Beta General, Normal (Truncated), and Triangular (Truncated)

Dose Response Models

  • Microbial hazards now include: Threshold Linear and Weibull
  • Acute chemical hazards now include: Cumulative Lognormal and Weibull
  • Chronic chemical hazards now include: Log-Logistic with Background, Probit, Restricted Weibull, and Restricted Log Probit

Consumption Models

  • Chronic consumption can now be defined in "g/kg-day"
  • Variability distributions now include: Beta, Beta General, Lognormal, Normal (Truncated), and Triangular (Truncated)

Sensitivity Analysis

  • Access a new tab for sensitivity analysis directly from Edit Risk Scenario page, to answer "what-if" questions
  • Perform sensitivity analysis on acute and chronic risk scenario
  • Analyze any model component
  • Print a report on sensitivity analysis results

Model Management

  • Create multiple repositories to manage your models
  • Share model repositories separately
  • Import and copy individual model elements

Reports

  • Enhanced report layout
  • Options for Word and Excel reports
  • Include weighted scenarios when generating risk estimates and scenario ranking reports
  • Report results for risk scenarios for chronic exposure as annualized or full lifespan
  • Multiple options for ranking risk estimates

Risk Scenarios

  • Create risk scenarios for exposure only models

UI Experience

  • Plotted dose response models and distribution charts for graphic representations of dose response relationships and variability in contamination and consumption