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Framework for Metals Risk Assessment - EPA

EPA 120/R-07/001 | March 2007 Framework for Metals Risk Assessment Office of the Science Advisor Risk Assessment Forum EPA 120/R-07/001 March, 2007 Framework for Metals Risk Assessment Office of the Science Advisor Risk Assessment Forum Environmental Protection Agency Washington, DC 20460 DISCLAIMER This document has been reviewed in accordance with Environmental Protection Agency policy.

Kinetic Modeling.....4-22 4.3.5. Metal Toxicity.....4-23 4.3.5.1. Noncancer Effects of Metals ... PBPK Physiologically based pharmacokinetic PBT Persistent bioaccumulative toxic PBTK Physiologically based toxicokinetic QSAR Quantitative structure -activity relationship

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Transcription of Framework for Metals Risk Assessment - EPA

1 EPA 120/R-07/001 | March 2007 Framework for Metals Risk Assessment Office of the Science Advisor Risk Assessment Forum EPA 120/R-07/001 March, 2007 Framework for Metals Risk Assessment Office of the Science Advisor Risk Assessment Forum Environmental Protection Agency Washington, DC 20460 DISCLAIMER This document has been reviewed in accordance with Environmental Protection Agency policy.

2 Mention of trade names or commercial products does not constitute endorsement or recommendation for use. ii CONTENTS LIST OF LIST OF FIGURES .. vii LIST OF ABBREVIATIONS AND ACRONYMS ..viii xvi EXECUTIVE SUMMARY .. xvii 1. INTRODUCTION ..1-1 PURPOSE AND AUDIENCE ..1-1 Metals Framework Metals Assessment National Ranking and National-Level Site-Specific Assessments ..1-8 KEY PRINCIPLES TO CONSIDER IN Metals RISK Metals are Naturally Occurring Constituents in the Environment and Vary in Concentrations Across Geographic All Environmental Media have Naturally Occurring Mixtures of Metals and Metals are Often Introduced into the Environment as Some Metals are Essential for Maintaining Proper Health of Humans, Animals, Plants, and The Environmental Chemistry of Metals Strongly Influences Their Fate and Effects on Human and Ecological The Toxicokinetics and Toxicodynamics of Metals Depend on the metal , the Form of the metal or metal Compound.

3 And the Organism s Ability to Regulate and/or Store the 2. Framework FOR Metals RISK HUMAN HEALTH AND ECOLOGICAL RISK Assessment : PLANNING AND PROBLEM FORMULATION ..2-1 Metals CONCEPTUAL MODEL ..2-4 Assessment Exposure Characterization of Effects/Hazard RISK CHARACTERIZATION ..2-16 3. ENVIRONMENTAL CHEMISTRY, TRANSPORT AND INTRODUCTION AND Hard and Soft Acids and Bases: The Stability of Complexes ..3-2 Biotic Methylation Abiotic Transformations ..3-6 Aquatic Processes ..3-7 Speciation and iii Importance of pH and Redox Conditions ..3-9 Ground Water and Metals Application of Partition Coefficients to metal Mobility in Ground Sediment metal Chemistry in Sediments.

4 3-14 Estimating metal Distribution in Soil Chemistry ..3-17 Key Parameters Affecting metal Bioavailability in Soils ..3-18 Adsorption Behavior of the Metals of Concern ..3-19 Aging of Metals in Soil ..3-19 Dissolution and Transformation of Soil metal Transfer to Atmospheric Behavior/Chemistry ..3-21 metal FATE AND Aquatic and Terrestrial Transport Pathways for Aquatic Transport Models ..3-26 Terrestrial Fate and ATMOSPHERIC FATE AND 4. HUMAN HEALTH RISK Assessment FOR Metals HUMAN EXPOSURE Background Susceptible Life Stage ..4-6 Pregnancy and Concurrent Damage or Disease.

5 4-6 Nutritional Genetic Polymorphisms and Environmental Release, Transport, and Route-Specific Differences in Effects ..4-8 Inhalation Dietary Exposure ..4-10 Incidental Soil Drinking Water Exposure ..4-11 Dermal Exposure ..4-12 Integrated modeling ..4-12 HAZARD Mixtures and Interactions ..4-14 Forms of iv Kinetic metal Noncancer Effects of Carcinogenic Effects of Issues Related to Evaluation of Toxicity Tests for Dose-Response RISK CHARACTERIZATION ..4-27 5. AQUATIC ECOLOGICAL RISK Assessment FOR Metals CHARACTERIZATION OF Background Forms of Exposure Pathway Fate and Transport of Toxicokinetics and Toxicodynamics (Bioavailability and Bioaccumulation Issues).

6 5-6 Aqueous Sediment Dietary Phase ..5-9 Bioaccumulation and Trophic CHARACTERIZATION OF Toxicokinetics/Toxicodynamics (Toxicity Issues)..5-14 metal Critical Body Residues ..5-17 RISK CHARACTERIZATION ..5-19 6. TERRESTRIAL ECOLOGICAL RISK Assessment FOR Metals CHARACTERIZATION OF Natural Occurrence of Forms of Exposure Soil Transport and Fate Bioaccumulation ..6-5 Soil Invertebrate Plant Wildlife CHARACTERIZATION OF Toxicity Tests ..6-13 metal Critical Body Residues ..6-15 Plant and Soil Invertebrate v Wildlife RISK CHARACTERIZATION.

7 6-18 REFERENCES .. R-1 APPENDIX A: Framework FOR Metals RISK Assessment CONTRIBUTORS AND vi LIST OF TABLES Table 3-1. Hard and soft acids ( metal cations) and bases (ligands).. 3-3 Table 3-2. Examples of organometallic 3-4 Table 3-3. Metals /metalloids involved in methylation Table 3-4. General trends of environmental factors affecting rates of methylation/demethylation .. 3-6 Table 4-1. metal essentiality for 4-17 Table 4-2. Summary of major differences in kinetic behavior of organic compounds compared to Metals and inorganic metal compounds in humans .. 4-19 Table 6-1. Qualitative bioavailability of metal cations in natural soils to plants and soil 6-8 Table 6-2.

8 Qualitative bioavailability of metal anions in natural soils to plants and soil 6-8 Table 6-3. Metals classified by their known LIST OF FIGURES Figure 1-1. Categories of Metals assessments under EPA statutory Framework .. 1-5 Figure 2-1. Risk Assessment /risk management process for Figure 2-2. Generic conceptual model for Metals risk Figure 2-3. Conceptual diagram for evaluating bioavailability processes and bioaccessibility for Metals in soil, sediment, or aquatic systems .. 2-12 Figure 3-1. Approximate positions of some natural environments in terms of Eh and pH .. 3-10 Figure 3-2. A generalized model Framework for chemical fate and transport in an aquatic 3-26 Figure 6-1.

9 Generalized representation of percent contribution of incidental soil ingestion to oral dose for wildlife at different soil ingestion rates and bioaccumulation factors and a bioavailability of 100 percent .. 6-10 vii LIST OF ABBREVIATIONS AND ACRONYMS 1 CFOK One-Compartment, First-Order Kinetics model ABA Absolute bioavailability aBLM Aquatic Biotic Ligand Model ANZECC Australian and New Zealand Environment and Conservation Council ARMCANZ Agriculture and Resources Management Council of Australia and New Zealand ATSDR Agency for Toxic Substances and Disease Registry AVS Acid-volatile sulfide AWQC Ambient Water Quality Criteria AWQS

10 Ambient Water Quality Standards BAF Bioaccumulation factor BCF Bioconcentration factor BF Bioaccessible fraction BLM Biotic Ligand Model BSAF Biota/sediment accumulation factor CBR Critical body residue CCA Chromated copper arsenate CEC Cation exchange capacity CHESS Chemical Equilibria in Soils and Solutions CMAQ Community Multiscale Air Quality model DEPM Dietary Exposure Potential Model DHHS Department of Health and Human Services DL Diffuse Layer model DOC Dissolved organic