Risk Assessment Methods for Biological and Chemical Hazards in Food 2020024661, 2020024662, 9781498762021, 9780429083525


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Table of contents :
Cover
Half Title
Title Page
Copyright Page
Table of Contents
Preface
Editor
Contributors
Section I: General Aspects
Chapter 1 Food Risk Assessment Framework: Foundations and Concepts
1.1 Introduction
1.2 Hazard versus risk
1.3 Risk Assessment and Its Role in Risk Analysis
1.4 Risk Assessment Framework
1.4.1 Microbial Risk Assessment Concepts
1.4.2 Chemical Risk Assessment Concepts
1.5 Deterministic versus Stochastic Risk Assessment
1.6 Uncertainty and Variability in Risk Assessments
1.7 Limitations and Challenges of Risk Assessment in Foods
1.8 Current Developments and Future Perspectives
References
Chapter 2 Risk Ranking: Moving towards a Risk-Based Inspection and Surveillance System
2.1 The Need for a Risk-Based Food Inspection and Surveillance System
2.2 Identifying Food Safety Risks: Risk Ranking
2.3 Risk Ranking Framework
2.3.1 Defining the Scope
2.3.2 Screening
2.3.3 Approach
2.3.4 Risk Variables and Metrics
2.3.5 Risk Ranking Model
2.3.6 Data Collection and Evaluation
2.3.7 Risk Ranking Results
2.4 Risk Ranking Tools
2.4.1 Decision Trees
2.4.2 Decision/Risk Matrices
2.4.3 Spreadsheet Calculators
2.4.4 Scoring Systems and Multicriteria Decision Analysis
2.4.5 Web-Based Tools
2.5 CASE STUDY: Development of a Risk-Based Inspection System
2.6 Conclusions
References
Chapter 3 Risk Metrics: Quantifying the Impact of Adverse Health Effects
3.1 Introduction: From Reactive to Risk-Based Food Safety Systems
3.2 Burden of Illness
3.2.1 Bottom-Up versus Top-Down Approaches
3.2.2 Outcome Trees
3.2.3 From Burden of Illness to Burden of Disease
3.3 Health Impact Metrics
3.4 Economic Impact Metrics
3.4.1 Costs Associated with Foodborne Disease
3.4.2 Methods Used to Estimate Costs
3.4.2.1 Cost-of-Illness
3.4.2.2 Willingness to Pay
3.5 Risk Ranking
3.6 Risk-Benefit Assessment
3.7 Conclusions
Acronyms
References
Chapter 4 Risk–Benefit Assessment of Foods
4.1 Introduction
4.1.1 The Need for Risk–Benefit Assessment
4.1.2 The Risk–Benefit Assessment Approach and the Role of the Risk–Benefit Question
4.2 Risk–Benefit Assessment in Food Safety and Nutrition
4.3 Qualitative and Quantitative Risk–Benefit Assessment Approaches
4.3.1 Identification of the Overall Health Impact: The Tiered Approach
4.3.2 Quantification of the Overall Health Impact
4.4 Risk–Benefit Assessment at Different Levels of Aggregation
4.4.1 Risk–Benefit Assessment for Food Components, Foods and Diets
4.4.2 Food Component Risk–Benefit Assessment
4.4.3 Food Risk–Benefit Assessment
4.4.4 Diet Risk–Benefit Assessment
4.5 Future Perspectives and Challenges of Risk–Benefit Assessment of Foods
Acknowledgement
References
Chapter 5 Application of Quantitative Risk Assessment Methods for Food Quality
5.1 Introduction
5.2 Concepts of Risk Assessment for Microbial Spoilage
5.3 Assessment of Microbiological Spoilage of Food and Beverages: Chemical and Microbiological Changes
5.4 Stages of Risk Assessment for Microbial Spoilage
5.5 Modeling Approaches for Spoilage Risk Assessment
5.5.1 Qualitative and Quantitative Exposure Assessment
5.5.1.1 Model Development
5.5.2 Model Types and Availability
5.5.3 Application of Predictive Microbiology within Exposure Assessment
5.6 Variability, Uncertainty, and Sensitivity for Spoilage Risk Assessment
5.7 Examples of Risk Assessment for Food Spoilage
5.8 Concluding Remarks
References
Chapter 6 Estimating Concentration Distributions: The Effect of Measurement Limits with Small Data
6.1 Introduction: Modeling the Observation
6.2 Parameter Estimation from Censored Data of Known Positive Concentrations
6.2.1 Bayesian Computation
6.3 Bayesian Estimation for True Zeros with Reported Microbial Colony Forming Units per Gram
6.4 Bayesian Estimation for True Zeros with Reported Microbial Plate Counts
6.5 Concluding Remarks
Appendix 6: Visual Exploring Using R and OpenBUGS
A.6.1 Censored Data and Likelihood Contour Plots
A.6.2 Bayesian Model with Censored Data
A.6.3 Bayesian Model with Censored Data and True Zeros
A.6.4 Bayesian Model with Plate Count Data
References
Chapter 7 Understanding Uncertainty and Variability in Risk Assessment
7.1 Introduction
7.2 Some Classical Definitions
7.2.1 Variability
7.2.2 Uncertainty
7.3 Understanding Uncertainty and Variability
7.3.1 A Proposal to Better Understand and Consider Variability and Uncertainty
7.3.2 Why Is There a Lack of Understanding?
7.3.3 Things Get Worse: When Uncertainty and Variability Are Exchangeable
7.4 Variability and Uncertainty in Practice
7.4.1 Conduct an Uncertainty Analysis
7.4.2 Considering Uncertainty and Variability Separately
7.4.2.1 Characterize the Variability/Uncertainty from the Data
7.4.2.2 Use Monte-Carlo Simulations to Integrate Variability
7.4.2.3 Characterize the Uncertainty
7.4.3 Prioritize the Different Sources of Uncertainty
7.4.4 Communicating Uncertainties and Their Impact on the Outcome
7.5 Discussion
References
Chapter 8 Application of Sensitivity Analysis Methods in Quantitative Risk Assessment
8.1 Introduction
8.2 Description of Methods and Approaches for Sensitivity Analysis
8.2.1 Mathematical Methods
8.2.1.1 Nominal Range Sensitivity Analysis (NRSA)
8.2.1.2 Break-Even Analysis (BEA)
8.2.2 Statistical Methods
8.2.2.1 Model Independent Methods
8.2.2.2 Model Dependent Methods
8.2.3 Graphical Methods
References
Section II: Microbial Risk Assessment
Chapter 9 Quantitative Methods for Microbial Risk Assessment in Foods
9.1 Introduction
9.2 Quantitative Resources for Risk Assessment
9.2.1 Human Data
9.2.1.1 Data on Human Cases
9.2.1.2 Data on Foodborne Outbreaks
9.2.2 Animal/Food Data
9.2.2.1 EFSA Monitoring Data
9.2.2.2 EU-Wide Baseline Survey Data
9.2.2.3 EU Rapid Alert System for Food and Feed Data
9.2.2.4 Other Resources, e.g. Data/Models from Scientific Literature
9.2.3 Consumption Data
9.2.3.1 EFSA Consumption Data
9.2.3.2 Other Consumption Data
9.2.3.3 Consumer Behaviour
9.2.4 Dose–Response Data
9.3 Risk Modelling Process and Model Integration
9.3.1 From Data to Risk: Data Treatment
9.3.2 Deterministic Models vs. Stochastic Models
9.3.3 Prevalence and Concentration
9.3.4 Models and Modelling Approaches
9.3.5 Model Integration: Population Risk versus Individual Risk
9.3.6 Modelling and Simulation Tools
9.4 Risk Assessment Output Interpretation: Importance of Uncertainty Analysis
9.4.1 Elements in Uncertainty Analysis
9.4.2 Interpretation of Uncertainty Analysis in MRA
9.5 Knowledge Exchange to Improve Microbial Risk Assessment
9.5.1 Current Limitations of Knowledge Exchange
9.5.2 Current Status of Knowledge Exchange
9.5.3 Novel Initiatives to Improve Knowledge Exchange
Disclaimer
Notes
References
Chapter 10 Hazard Identification: Microbial Risks along the Food Chain
10.1 Overview and Approaches to Hazard Identification
10.1.1 Hazard Identification Incorporating a Quantitative Approach: Listeria monocytogenes in Ready-to-Eat Foods
10.1.2 Qualitative Approach to Hazard Identification: Microbial Risks for Primary Producers of Leafy Vegetables
10.2 Microorganisms in Foods
10.2.1 General Pathogen Characteristics
10.2.2 Sources of Microorganisms
10.2.3 Exposure Routes to Microorganisms
10.2.4 Survival and Growth of Microorganisms in Foods
10.2.5 Food Production and Beyond
10.3 Human Adverse Health Outcomes
10.4 The Population Burden of Disease
10.4.1 Public Health Surveillance
10.4.2 Estimating the Burden of Foodborne Disease
10.4.3 Attributing Illnesses to Foods
10.5 Conclusions
References
Chapter 11 Predictive Microbiology Tools for Exposure Assessment
11.1 Predictive Microbiology for Quantitative Microbiological Risk Assessment
11.2 Predictive Microbiology Model Types
11.3 Primary Models: Growth, Interaction and Inactivation Models
11.3.1 Growth Models
11.3.1.1 Gompertz and Logistic Models
11.3.1.2 Baranyi and Roberts Model
11.3.1.3 Buchanan Three-Phase Linear Model
11.3.2 Interaction Models
11.3.2.1 Jameson Effect Model
11.3.2.2 Lotka–Volterra Model
11.3.3 Phoenix Phenomenon Model
11.3.4 Inactivation Models
11.3.4.1 Bigelow Model
11.3.4.2 Weibull Model
11.3.4.3 Shoulder/Tail Model (Geeraerd Model)
11.4 Secondary Models
11.4.1 Ratkowsky or Square Root Model
11.4.2 Arrhenius-Type Model
11.4.3 Polynomial or Response Surface Models
11.4.4 Bigelow Model
11.5 Transfer Models
11.6 Mixing, Partitioning and Others
11.6.1 Mixing
11.6.2 Partitioning
11.6.3 Removal
11.7 Growth Probability Models (Growth/No Growth)
11.8 Model Generation Process
11.8.1 Data Generation: Experimental Design, Data Acquisition and Data Process
11.8.1.1 Experimental Design
11.8.1.2 Data Collection
11.8.1.3 Data Processing
11.8.2 Model Fitting and Goodness-of-Fit Indexes
11.8.2.1 Model Fitting
11.8.2.2 Goodness-of-Fit Indexes
11.8.3 Model Validation
11.9 Conclusions
References
Chapter 12 Modelling Cross-Contamination in Food Processing
12.1 Introduction: Transfer and Cross-Contamination
12.2 Cross-Contamination as a Non-Log-Linear Process: Implications for Cross-Contamination Models and Risk Assessment
12.3 Towards a Generic Mechanistic Model for Cross-Contamination in Food Processing
12.3.1 Models for Cross-Contamination during Industrial Broiler Processing
12.3.2 Models for Cross-Contamination during Grinding and Slicing
12.4 Overview of Models in Large-Scale Food Processing
12.5 Cause and Implications of the Tailing Phenomenon
12.6 Evaluation of the Performance of Cross-Contamination Models
12.7 Summary and Outlook
Appendix 12.1 Comparison of the Models Used by Sheen and Hwang (2010), Nauta et al (2005) and Møller et al (2012)
References
Chapter 13 Expert Systems Applied to Microbial Food Safety
13.1 Introduction
13.2 Software Presentation
13.3 User Perspective
13.4 Challenges and Opportunities
References
Chapter 14 Dose–Response Models for Microbial Risk Assessment
14.1 Introduction
14.2 Exponential Model
14.3 Beta-Poisson Model
14.4 Fitting Challenge Trials Data to Exponential and Beta-Poisson Models
14.5 Dose-Response Model from Human Outbreak Data
14.6 Dose–Response Model Combining Surveillance Epidemiological Data and Exposure Data
14.7 Conclusions
References
Section III: Chemical Risk Assessment
Chapter 15 Quantitative Chemical Risk Assessment Methods
15.1 Introduction
15.2 Chemical Risk Assessment
15.2.1 Hazard Identification
15.2.2 Hazard Characterization
15.2.3 Exposure Assessment
15.2.4 Risk Characterization
15.3 Risk Assessment Methods
15.3.1 Conceptual Model of Risk Assessment
15.3.2 Deterministic Approach
15.3.3 Probabilistic Approach
15.3.4 Tiered Approach
15.3.5 Uncertainty Analysis
15.4 Current and Future Challenges in Chemical Risk Assessment
15.4.1 Mixture Risk Assessment
15.4.1.1 How to Group Substances in a Mixture
15.4.1.2 How to Assess the Risk of a Chemical Mixture
15.4.2 Aggregate Exposure and Biomonitoring Data
15.4.3 Integrating Toxicokinetic Models in Chemical Risk Assessment
15.5 Epidemiology and Chemical Risk Assessment
15.6 Conclusion
Acronyms
References
Chapter 16 Uncertainty Analysis in Chemical Risk Assessment
16.1 Introduction
16.2 Definition of Uncertainty
16.3 Classification of Uncertainty Sources
16.4 Uncertainty Analysis Approach
16.4.1 Preliminary Step: Planning the Uncertainty Analysis
16.4.2 Step 1: Identification and Description of Uncertainty Sources
16.4.3 Step 2: Individual Assessment of Uncertainties
16.4.4 Step 3: Assessing the Impact of the Combined Uncertainties
16.4.5 Step 4: Prioritization of Sources of Uncertainty
16.4.6 Step 5: Communication of the Results of the Uncertainty Analysis
16.5 Conclusion
References
Chapter 17 Examples of Quantitative Mycotoxin Risk Assessments: Use and Application in Risk Management
17.1 Introduction
17.2 Mycotoxins
17.3 Risk Assessment
17.3.1 Dietary Exposure Assessment of Mycotoxins
17.4 Quantitative Exposure Assessment of Mycotoxins through Dietary Exposure Modelling
17.4.1 Acute vs. Chronic Dietary Exposure Assessments
17.4.1.1 Chronic Exposure Assessment Models
17.4.1.2 Acute Exposure Assessment Models
17.4.2 Case Studies
17.4.2.1 Quantitative Assessment of Risk Derived from Dietary Intake of OTA
17.4.2.2 Quantitative Assessment of Risk Derived from Dietary Exposure to Deoxynivalenol
17.4.2.3 Quantitative Assessment of Risk Derived from Dietary Intake of T2-HT2
17.4.2.4 (Integrative) Quantitative Assessment of Carcinogenic Risk Derived from Dietary Intake of Aflatoxin B1
17.5 Quantitative Exposure Assessment of Mycotoxins Based on Food Chain Data
17.5.1 Case Study 1: Simulation of Consumer Exposure to Deoxynivalenol According to Wheat Crop Management and Grain Segregation (Le Bail et al. 2005)
17.5.1.1 Preharvest
17.5.1.2 Postharvest
17.5.1.3 Processing
17.5.2 Case Study 2: Evaluation of Strategies for Reducing Patulin Contamination of Apple Juice Using a Farm-to-Fork Risk Assessment Model (Baert et al., 2012)
17.5.2.1 Preharvest
17.5.2.2 Postharvest
17.5.2.3 Processing
17.5.3 Case Study 3: A Stochastic Simulation Model for the Quantitative Assessment of the Concentration of Mycotoxins in Milk and the Related Human Exposure (Signorini et al. 2012)
17.6 Concluding Remarks
References
Index
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Index

dietary exposure modelling, 489–491 acute exposure assessment models, 490–491 aflatoxin B1, 497–499 chronic exposure assessment models, 490

522

Index

Regression coefficients (RCs), 202 Regression empirical parameters, of Gompertz model, 306 Relative risk, 28–30 Removal process, 327–328 Response surface models, 322 Reverse dosimetry, 448 Risk analysis component interaction, 6 components, 6, 48 decision making, 5–6 definition, 5 qualitative/quantitative evaluation, 5 Risk assessment framework, 7 analysis role, 5–6 chemical risk assessment (CRA), 9–10 deterministic vs. stochastic, 10–11 developments and future perspectives, 12–13 hazard vs. risk, 4–5 limitations and challenges, 11–12 microbial risk assessment (MRA), 7–9 uncertainty and variability, 11 Risk assessment methods, 273 conceptual model, 438–439 deterministic approach, 439 probabilistic approach, 440 tiered approach, 441 uncertainty analysis, 441–442 Risk Assessment Modelling and Knowledge Integration Platform (RAKIP), 400, 403 Risk assessment package mc2d, 400 Risk assessors, 462 Risk-based food safety systems Codex Alimentarius, 50 decision-making, 49 framework, 49 General Food Law, 50 International Programme on Chemical Safety, 50–51 risk matrix, 51–52

wicked problem, 48 Risk-based inspection system database development, 38 description, 37–38 inspection frequency, 39–40 level classification, food categories, 38 level classification, food establishments, 38–39 overall score, 39 strategic goals development, 40 Risk-benefit assessment (RBA), 69–71 categorization, 108 challenges, 108 definition, 82–83 different level aggregation diet risk, 103–107 food component risk, 96–99 food risk, 99–103 epidemiological analyses, 109 European projects, 81 feasible region, 110 food safety and nutrition, 85–91, 110 future perspectives and challenges, 107–110 hazard identification, 109 need for, 80–81 qualitative and quantitative approach identification, 91–93 quantification, 93–95 risk–benefit question (RBQ), 83, 85 risks and benefits, 109 steps, 83–85 Risk–benefit question (RBQ), 83, 85, 95, 108 Risk characterization process, 437, 450 Risk/decision matrix, 35 Risk metrics economic impact metrics costs, estimate methods, 64–68 costs, foodborne disease, 62–64 health impact metrics, 56–61 illness burden

523

Index

bottom-up vs. top-down approaches, 52–54 to burden of disease, 56 outcome trees, 54–56 risk-based food safety systems, 48–52 risk ranking, 68–69 Risk modelling process and model integration data to risk, data treatment, 226–228 deterministic models vs. stochastic models, 229–231 modelling and simulation tools, 245–248 models and modelling approaches Bayesian network (BN), 240 Bayesian techniques, 240 complexity, 238–239 cross-contamination, 242 drying/fermentation processes, 241 modular process risk model (MPRM), 238 probability distributions, 235, 237 process risk model (PRM), 238 population risk vs. individual risk, 242–245 prevalence and concentration approximation, 234 Bayesian methods, 235 Clopper–Pearson method, 234 ingredients mixing, 231 log-normal distribution, 232 measurement and expression, 231 microbiological testing, 232 probability distributions, 233 Risk Ranger, 35 Risk ranking, 68–69 chart, 32 food inspection and surveillance system, 18 food safety risks identification, 18–20 framework, 20, 22 approach, 24–27

data collection and evaluation, 30–31 results, 31 risk ranking model, 28–30 risk variables and metrics, 27–29 scope, 20–24 screening, 24 methods, 21, 33, 476 risk-based inspection system, 37–40 tools, 33 decision/risk matrices, 35 decision trees, 33–34 scoring systems and multicriteria decision analysis, 35–36 spreadsheet calculators, 35 web-based, 36–37 Risk Ranking Categorization System, 23 @RISK software, 504, 506 R software, 400

S Salmonella sp. S. enterica, 275, 281, 284, 285, 316, 317, 364–365, 371, 374 S. typhimurium, 316 Salmonellosis, 59–61 Secondary models, 304 Arrhenius-type, 321–322 Bigelow, 322–323 polynomial/response surface, 322 Ratkowsky/square root, 320–321 transfer, 323–324 Second-order Monte-Carlo simulation, 174–175, 182, 187 illustration, 183 resources, 186 “Semi-mechanistic” models for crosscontamination, 361 Semi-quantitative approach, 27–28 Sensitivity analysis methods, 475 application, 192 building, 192

524

Index

description, 191–192 methods and approaches all-factors-at-a-time (AAT), 193–194 graphical methods, 204–206 mathematical methods, 196–199 one-factor-at-a-time (OAT), 193–194 quantitative microbial risk assessment (QMRA) model, 194, 196 statistical methods, 199–204 traditional, 193 microbial food safety, 192–193 SHEDS-high-throughput tool, 447 Sheen and Hwang model, 380–381 Sheffield method, 473 Shoulder/tail model, 319–320 Sigmoid models, 304 Simulation-based models, 501 Simulation tools, 245–247 “Single-hit concept,” 410 SMPHs, see Summary measures of population health SNMU, see Sparse non-negative matrix underapproximation Software, 246–247 Sparse non-negative matrix underapproximation (SNMU), 444 Spoilage, 119 Spoilage risk assessment modeling approaches development, 128–129 predictive microbiology, 129 qualitative and quantitative exposure, 127–128 types and availability, 129 sensitivity, 131 uncertainty and variability, 130–131 sQMRA, see Swift quantitative microbial risk assessment SRCs, see Standardized regression coefficients

SRRCs, see Standardized rank regression coefficients SSSP software, 404 Standardized rank regression coefficients (SRRCs), 203 Standardized regression coefficients (SRCs), 203 Statistical design optimization theory, 411 Statistical methods description, 199–200 model dependent methods correlation coefficients (CCs), 203 rank regression approach, 203 regression indexes, 202 software packages, 204 model independent methods ANOVA, 200–201 classification and regression tree (CART), 201–202 other methods, 202 Statistical model, 357 Statistical tools, 388 Stochastic models, 303, 486 Stochastic predictive microbiology, 303, 339 Stochastic simulation model, 506–507 Summary measures of population health (SMPHs), 57 Surveillance systems, 287, 288 Swift quantitative microbial risk assessment (sQMRA), 35 Sym'Previus software, 389, 402, 404

T T2-HT2, dietary intake of, 496–497 Tailing phenomenon, 370–375 Target organ toxicity dose (TTD), 446 Tertiary models, 304 Threshold model, 411 TI, see Tolerable intake Tiered approach, 91–93, 441 TK, see Toxicokinetic models Tolerable intake (TI), 435

525

Index

Top-down approach, 26, 285 Total transfer potential (TTP), 376–377 Toxicokinetic (TK) models, 434, 448–449 Toxicological surveys, 449 Toxin production, 277 Traditional epidemiology, 281 Transfer models, 323–324 Transparency, 476 TTD, see Target organ toxicity dose TTP, see Total transfer potential Two-dimensional (2-D) Monte Carlo simulations, 440, 502 Two model approaches, 313

U Uncertainty characterize errors, 183–186 limited number, 182 second-order Monte-Carlo simulation, 182–183 conduct analysis, 177–179 data characterize, 179 description, 168–169 model, 170 ontology categories, 170–171 ontology data, 171 outcome impact, 188 risk assessments, 170 scenario, 169 sources prioritize, 187–188 stages, 178 understanding exchangeable, 176–177 lack of, 174–176 proposal to, 171–173 Uncertainty analysis, 248–249, 441–442, 458–459 approaches, 462–465 communication, 476–477 identification and description, 467–472 impact, 473–474

individual assessment, 468, 473 planning, 465–466 prioritization of sources, 475–476 classification of, 459–462 definition of, 459 elements, 249–251 expressions types, 252–253 interpretation, MRA, 251, 254–256 Uncertainty and variability, risk assessment, 11 Understandability, 477 United States Department of Agriculture Agricultural Research Service (USDAARS), 388 USDA-ARS, see United States Department of Agriculture Agricultural Research Service User-friendly software programs, 304, 312 U.S. Food and Drug Administration Bacterial Analytical Manual, 333 U.S. health survey data, 289

V Variability categories, 167 characterization example, 169 considered, 184 data characterize, 179 description, 167 different levels, 173 distributions, 168 levels mixing, 173 Monte-Carlo simulations integration, 180–181 risk, 168 understanding exchangeable, 176–177 lack of, 174–176 proposal to, 171–173 Variability and uncertainty

526

Index

communicating uncertainties and outcome impact, 188 one-dimensional Monte-Carlo simulation, 185 principle of derivation, 180 prioritize, sources of uncertainty, 187–188 separate considering practice characterize uncertainty, 181–187 data characterize, 179–180 Monte-Carlo simulations to integrate variability, 180–181 two-dimensional Monte-Carlo simulation, 187 uncertainty analysis conduct, 177–179 understanding exchangeable, 176–177 lack of, 174–176 proposal to, 171–173 Vibrio parahaemolyticus, 276, 278 Visual exploring Bayesian model, R and OpenBUGS censored data, 159–160

censored data and likelihood contour plots, 158 censored data and true zeros, 160–161 plate count data, 161–162

W Weibull models, 319, 363 Well-studied cross-contamination models, 378 WGS, see Whole genome sequencing Whole genome sequencing (WGS), 281–282 World Health Organization, 289–290

Y Years lived with disability (YLDs), 57–58 Years of life lost (YLL), 57 Yersinia enterocolitica, 327–328 YLDs, see Years lived with disability YLL, see Years of life lost

527