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Principles of Characterizing and Applying Human Exposure Models

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Principles of Characterizing and Applying Human Exposure Models 1 2 3 4 5 6 7 Harmonization Project Document No. X 8 9 10 PRINCIPLES OF CHARACTERIZING AND APPLYING 11 HUMAN EXPOSURE MODELS 12 13 14 15 DRAFT 16 17 18 Prepared by the 19 20 Exposure Modelling Subcommittee of the IPCS Harmonization Project Exposure Assessment 21 Working Group 22 23 International Programme on Chemical Safety 24 World Health Organization 25 Geneva 26 27 28 29 November 2004 30 Harmonization Project Document No. X 1 TABLE OF CONTENTS 2 3 FOREWORD............................................................................................................................4 4 5 LIST OF MEMBERS OF THE EXPOSURE MODELLING SUBCOMMITTEE OF 6 THE IPCS HARMONIZATION PROJECT EXPOSURE ASSESSMENT WORKING 7 GROUP .....................................................................................................................................6 8 9 LIST OF CONTRIBUTORS ..................................................................................................6 10 11 LIST OF ACRONYMS AND ABBREVIATIONS ...............................................................8 12 13 1. INTRODUCTION..........................................................................................................10 14 1.1 Background and rationale ............................................................................................10 15 1.2 Goals of this work........................................................................................................10 16 1.3 Definitions and terminology ........................................................................................11 17 1.4 Exposure model applications .......................................................................................12 18 19 2. ASPECTS OF EXPOSURE MODELLING....................................................................14 20 2.1 Conceptual models.......................................................................................................14 21 2.2 Computational elements of a model ............................Error! Bookmark not defined. 22 2.3 Approaches to exposure modelling..............................................................................16 23 2.3.1 Mechanistic versus empirical models...................................................................16 24 2.3.2 Deterministic versus stochastic (probabilistic) models........................................17 25 2.3.3 Hybrid models ......................................................................................................18 26 2.4 Criteria for selecting a model.......................................................................................18 27 2.5 Quality assurance planning for modelling ...................................................................19 28 2.6 Model evaluation .........................................................................................................20 29 2.7 Conceptual domains in exposure modelling................................................................21 30 2.7.1 Target population domain ....................................................................................22 31 2.7.2 Location domain...................................................................................................23 32 2.7.3 Time domain.........................................................................................................24 33 2.8 Linking exposure modelling to risk assessment ..........Error! Bookmark not defined. 34 35 3. CONCENTRATION, EXPOSURE, AND DOSE MODELS.....................................28 36 3.1 Concentration models ..................................................Error! Bookmark not defined. 37 3.1.1 Air concentration models.....................................................................................28 38 3.1.2 Surface contamination models.............................................................................30 39 3.1.3 Drinking-water concentration models..................................................................32 40 3.1.4 Food concentration models..................................................................................35 41 3.2 Exposure and dose models...........................................................................................36 42 3.2.1 Inhalation models.................................................................................................36 43 3.2.2 Dermal exposure models......................................................................................39 44 3.2.3 Ingestion models..................................................................................................41 Principles of Characterizing and Applying Human Exposure Models 1 3.2.4 Multimedia models..............................................................................................44 2 3.2.5 Multichemical exposure models..........................................................................47 3 3.2.6 Physiologically based pharmacokinetic (PBPK) models.....................................48 4 3.2.7 Source apportionment models..............................................................................50 5 6 4. RECOMMENDATIONS FOR CHARACTERIZING EXPOSURE MODELS......52 7 4.1 General model description ...........................................................................................52 8 4.2 Model inputs................................................................................................................53 9 4.3 Model processes...........................................................................................................54 10 4.4 Model outputs..............................................................................................................54 11 12 REFERENCES CITED.........................................................................................................58 13 14 15 Harmonization Project Document No. X 1 FOREWORD 2 3 Harmonization Project Documents are a new family of publications from the International 4 Programme on Chemical Safety (IPCS) — a cooperative programme of the World Health 5 Organization (WHO), the International Labour Organization (ILO), and the United Nations 6 Environment Programme (UNEP). Harmonization Project Documents join the Environmental 7 Health Criteria (EHC) methodology (yellow cover) series of documents as authoritative 8 documents on methods for the risk assessment of chemicals. 9 10 The main impetus for the current coordinated international, regional, and national efforts on 11 the assessment and management of hazardous chemicals arose from the United Nations 12 Conference on Environment and Development (UNCED) held in 1992 and was reconfirmed 13 at the 2002 World Summit on Sustainable Development. UNCED Agenda 21, Chapter 19, the 14 “blueprint” for the environmentally sound management of toxic chemicals under the 15 principles of sustainable development, has guided most international and national chemical- 16 related activities. Chapter 19 is the agreed upon, endorsed international programme of action 17 of governments for developing and implementing national programmes for management of 18 chemicals within the principles of sustainable development. 19 20 The IPCS project on the Harmonization of Approaches to the Assessment of Risk from 21 Exposure to Chemicals (Harmonization Project) is conducted under Agenda 21, Chapter 19. 22 The Intergovernmental Forum on Chemical Safety (IFCS) Forum III, held in Salvador da 23 Bahia in October 2000, agreed on Priorities for Action Beyond 2000, which further define the 24 actions recommended to be taken. Forum III declared that by 2004, IPCS and the Inter- 25 Organization Programme for the Sound Management of Chemicals (IOMC, which comprises 26 seven intergovernmental organizations) should have ensured that recommendations for 27 harmonized assessment approaches were available for terminology, cancer, and reproductive 28 and developmental toxicology and that common principles for the assessment approach to 29 other specific toxicological end-points, such as immunotoxicology, endocrine disruptors, and 30 ecotoxicology, should be adopted wherever possible. 31 32 The IPCS Harmonization Project, which is ongoing, states that “harmonization,” in the 33 context of chemical risk assessment, should not simply be equated with standardization. It is 34 not a goal of the project to standardize risk assessments globally, as that is considered to be 35 neither appropriate nor feasible. Instead, harmonization is thought of as an effort to strive for 36 consistency among approaches and to enhance understanding of the various approaches to 37 chemical risk worldwide. Thus, harmonization is defined, in a step-wise fashion, as an 38 understanding of the methods and practices used by various countries and organizations so as 39 to develop confidence in, and acceptance of, assessments that use different approaches. It 40 further involves a willingness to work towards convergence of these approaches or methods 41 as a longer-term goal. 42 43 Achieving harmonization of approaches is considered to provide a framework for comparing 44 information on risk assessment; understanding of the basis for exposure standards for specific 45 chemicals in different countries; savings of time and expense by sharing information and 46 avoiding duplication of work; and credible science through better communication among 47 organizations and peer review of assessments and assessment procedures. The stated project 48 mission is to ensure better chemical risk assessment and
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