Uncertainty and Data Quality in Exposure Assessment: Part 1: Guidance Document on Characterizing & Communicating Uncertainty in Exposure Assessment. Part ... Data Quality in Chemical Exposure Assessment

Assessment of human exposure to chemicals is a critical input to risk assessment and ultimately to decisions about control of chemicals. This two-part publication aims to improve the quality of information available to decision-makers and its communication. Part one sets out ten principles for characterizing and communicating uncertainty in exposure assessment. A tiered approach to the evaluation of uncertainties using both qualitative (simple) and quantitative (more complex) methods is described. Different sources of uncertainty are identified, and guidance is provided on selecting the appropriate approach to uncertainty analysis, as dictated by the objectives of the assessment and information needs of decision-makers and stakeholders. Part two addresses the quality of data used in exposure assessment, and sets out four basic hallmarks of data quality - appropriateness, accuracy, integrity and transparency. These hallmarks provides a common vocabulary and set of qualitative criteria for use in the design, evaluation and use of exposure assessments to support decisions.--Publisher's description. TITLE......Page 2 COPYRIGHT......Page 3 TABLE OF CONTENTS......Page 4 FOREWORD......Page 7 PART 1: GUIDANCE DOCUMENT ON CHARACTERIZING AND COMMUNICATING UNCERTAINTY IN EXPOSURE ASSESSMENT......Page 8 ACKNOWLEDGEMENTS......Page 9 MEMBERS OF THE WHO/IPCS WORKING GROUP ON UNCERTAINTY IN EXPOSURE ASSESSMENT......Page 10 LIST OF ACRONYMS AND ABBREVIATIONS......Page 12 EXECUTIVE SUMMARY......Page 13 1. INTRODUCTION......Page 16 1.1 Why uncertainty analysis?......Page 17 1.3 Scope and objectives......Page 18 2.1 Historical context and background......Page 20 2.2 Rationale for characterizing uncertainty in exposure assessment......Page 21 2.3 Planning for uncertainty analysis in exposure assessment......Page 24 3.1 Approaches and steps in exposure assessment......Page 30 3.2 Nature of uncertainty sources......Page 31 4.1 Regulatory background......Page 45 4.2 Determination of the tiered level......Page 46 4.3 Summary of the tiered approach......Page 51 5.1 Qualitative uncertainty characterization......Page 53 5.2 Quantitative uncertainty characterization......Page 61 5.3 Data and resource requirements......Page 75 5.4 Interpretation of results......Page 76 5.5 Use of uncertainty analysis in evaluation and validation......Page 79 5.6 Summary of uncertainty characterization methods......Page 80 6.1 Introduction and historical background......Page 82 6.2 The position of exposure and uncertainty assessment in the risk communication process......Page 84 6.3 Proposals for the presentation/visualization of uncertainty......Page 89 6.4 Avoiding typical conflicts in risk communication......Page 96 6.5 Conclusions......Page 98 7. CONCLUSIONS......Page 99 8. REFERENCES......Page 100 GLOSSARY OF TERMS......Page 112 A1.3 Sources of uncertainty......Page 120 A1.5 Characterization and evaluation of uncertainty......Page 121 A1.6 Communication......Page 123 Ap1.2 Scenario......Page 126 Ap1.3 Model......Page 128 Ap1.4 Parameters: sample uncertainty......Page 130 Ap1.5 Exposure assessment result......Page 132 A2.2 Methods used in the case-study......Page 134 A2.3 Case-study: PBLx exposure from fish ingestion......Page 138 A2.4 Summary of the case-study......Page 153 PART 2: HALLMARKS OF DATA QUALITY IN CHEMICAL EXPOSURE ASSESSMENT......Page 154 Preparation of public review draft......Page 155 Preparation of final document......Page 156 1. INTRODUCTION......Page 158 2. WHAT DO WE MEAN BY “DATA” IN EXPOSURE ASSESSMENT?......Page 160 3. TOWARDS A BROADER DEFINITION OF QUALITY IN EXPOSURE ASSESSMENT: HALLMARKS OF DATA QUALITY......Page 162 3.1 Appropriateness......Page 164 3.2 Accuracy......Page 165 3.3 Integrity......Page 166 3.4 Transparency......Page 168 4. FROM EXPOSURE DATA QUALITY TO THE QUALITY OF EXPOSURE ASSESSMENTS......Page 170 5. CONCLUSIONS......Page 172 6. REFERENCES......Page 173 THE HARMONIZATION PROJECT DOCUMENT SERIES......Page 174 pt. 1. Guidance document on characterizing and communicating uncertainty in exposure assessment. Introduction Context, concepts and definitions Sources of uncertainty Tiered approach to uncertainty analysis Uncertainty characterization methods, interpretation and use Communication Conclusions pt. 2. Hallmarks of data quality in chemical exposure assessment. Introduction What do we mean by "data" in exposure assessment? From exposure data quality to the quality of exposure assessments Conclusions.