Environmental Health Risk Assessment—Guidelines for ...

1 Environmental Health RISK ASSESSMENTiContentsFigures ..viTables ..viiObjectives ..viiiAudience ..viiiAcknowledgments ..ixPART 1: BASIC CONCEPTS IN Environmental Health RISK ASSESSMENT ..1 Chapter 1: Introduction to Environmental Health risk assessment .. What is risk assessment? .. When to undertake risk assessment .. Types of risk assessment .. The distinction between risk assessment and risk management .. Evaluating risk assessment methods .. Risk assessment models and formats .. The five stages of Environmental Health risk assessment (EHRA) .. Risk assessment frameworks .. Tiered approaches to EHRA .. Deterministic versus probabilistic estimates in EHRA .. Environmental Health risk assessment and Health impact assessment.

2 Environmental Health risk assessment and the precautionary principle ..14 Chapter 2: Problem formulation and scope .. Identifying and describing issues within existing Environmental conditions .. Identifying and describing susceptible populations .. Identification of potential exposure Potential interactions between agents .. Identifying potential management options that may mitigate exposure .. What risk and other technical assessments are necessary to evaluate risk and discriminate between potential risk management options? ..23 Chapter 3: Hazard identification and dose response assessment .. Introduction .. Hazard Dose response assessment .. The prime role of animal studies in risk assessment .. Dose scaling.

3 Dose response curve shape, construct and analysis .. Hormesis .. Dose response modelling .. Benchmark dose Threshold versus non-threshold responses in risk assessment .. Threshold versus non-threshold approaches implications for risk assessment .. Science policy and the selection of threshold and non-threshold models ..40 Environmental Health RISK ASSESSMENTENVIRONMENTAL Health RISK MANAGEMENT iiiiiChapter 4: Exposure assessment .. Introduction .. Terminology used in exposure assessment .. Planning an exposure assessment .. Development of a conceptual site model .. Approaches to quantifying exposures .. Exposure assessment calculations .. Data analysis and evaluation .. Individual exposure, dose and risk Issues in exposure assessments.

4 Exposure assessment of volatile agents .. Exposure duration .. Adjustments for sensitive Default values for exposure assessments .. Sources of exposure assessment data ..64 Chapter 5: Risk characterisation .. Introduction .. Key principles in Environmental Health risk characterisation .. Quantitative and qualitative risk characterisation .. Risk estimation .. Toxicological reference values (TRVs) in common use .. Determination of NO(A)ELs, ADIs (RfD) and TDIs for humans .. Toxicological reference values derived using a non-threshold approach .. Age-specific adjustment factors .. Combining risk estimates .. Target risk levels .. Principles for setting risk-based Environmental Health guideline values .. Guidance on selecting sources of toxicological data and Environmental Health criteria.

5 Chemicals with no available toxicity data .. QSAR and read across techniques .. Uncertainty and sensitivity analysis .. Interplay of scientific judgement and science policy ..85 Chapter 6: Community engagement .. Introduction .. Risk perception and risk communication in the context of community engagement .. Risk communication things to know and things to avoid .. Risk communication understanding conflicts .. Planning risk 7: Reviewing and appraising an Environmental Health risk assessment report .. Problem formulation and scope .. Hazard Dose response checklist .. Selection of guideline values .. Data presentation .. Exposure assessment .. Risk characterisation .. Confirmation of utility .. General assessment and report presentation.

6 100 PART 2: ADDITIONAL GUIDANCE ON SELECTED ISSUES ..103 Chapter 8: Data collection and Environmental distribution .. Environmental sampling and Analytical methodologies .. Quality assurance of data used in site-specific Health risk assessment .. Data analysis and presentation .. Some principles of graphical representation .. Censored data ..113 Chapter 9: Evaluation of toxicity data .. Toxicity testing major in vivo study types .. Guidance on evaluating and interpreting toxicity tests .. Evaluating the weight of evidence and considering the toxicology database in toto .. Developments in toxicity testing ..116 Chapter 10: Use of epidemiological data .. Introduction .. Types of epidemiological study .. Investigation of apparent clusters.

7 Bias and confounding: key concepts in Environmental epidemiology .. Assessing the relationship between a possible cause and an outcome .. The strengths and limitations of observational epidemiology versus experimental toxicology .. Critical evaluation of published research .. Undertaking Health studies ..131 Chapter 11: Assessment of carcinogens .. Methods for the hazard identification of carcinogens .. Guidance on assessing Classification of carcinogens .. When is a carcinogenic response relevant to humans? .. IPCS program on chemical Quantitative risk assessment of An alternative approach to quantitative carcinogen risk assessment? ..145 Environmental Health RISK ASSESSMENTENVIRONMENTAL Health RISK MANAGEMENTvivChapter 12: Assessing multiple routes and sources of exposure.

8 Risk assessment of chemical mixtures .. Assessment of representative The toxicity equivalence factor Summation of risk estimates .. Component elimination or simplification .. Biomarker approach .. International programs and Other reviews of chemical mixtures 13: Exposure Using point estimates and probability distributions .. Monte Carlo Integration of exposure with EHRA outcomes ..160 Chapter 14: Biomonitoring .. Biomarkers .. Choice of tissue .. Choice of a test .. Influences on biological monitoring results .. Exposure and biological monitoring results .. Abnormal results .. Health monitoring .. Biomonitoring and blood lead ..167 Chapter 15: Microbiological risk assessment .. Introduction .. Definitions.

9 General principles .. Microbiological risk assessment paradigms and frameworks .. Expression of microbiological 16: Guidance on route-specific EHRA .. Assessment of site contamination National Environmental Protection Measure .. Air pollutants .. Food contaminants .. Water contamination ..175 PART 3: REGULATORY CONTEXT ..177 Chapter 17: Australian regulation of chemical Overview of the chemical risk assessment agencies .. National Industrial Chemicals Notification and Assessment Scheme .. Australian Pesticides and Veterinary Medicines Authority (APVMA) .. Role of the Office of Chemical Safety (OCS) in public Health risk assessment .. Role of the Department of Sustainability, Environment, Water, Population and Communities (DSEWPC) in Environmental risk assessment.

10 Standards Australia model of risk management .. Risk management associated with genetically modified organisms .. Supporting professional organisations ..187 Chapter 18: International programs and guidance on EHRA .. United States programs .. United Kingdom programs .. International programs dealing with chemical safety .. Programs for developing alternatives to animal testing .. Integration of human Health and ecotoxicology ..194 Appendix 1: Guidance on the evaluation of toxicity studies ..195 Appendix 2: Extracts from a 2010 NHMRC discussion paper on Health -based targets for microbial safety of drinking water supplies ..204 Abbreviations ..208 Glossary ..214 References ..225 Environmental Health RISK ASSESSMENTENVIRONMENTAL Health RISK MANAGEMENT viiviTABLEST able 1: Factors influencing the absorption of chemicals.