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Considerations for Developing Alternative Health Risk Assessment

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Considerations for Developing Alternative Health Risk Assessment 1 EPA/600/R-06/013A 2 March 2006 3 Final External Review 4 5 6 Considerations for Developing Alternative 7 Health Risk Assessment Approaches for 8 Addressing Multiple Chemicals, 9 Exposures and Effects (External Review Draft) 10 11 12 13 14 15 National Center for Environmental Assessment 16 Office of Research and Development 17 U.S. Environmental Protection Agency 18 Cincinnati, OH 45268 19 20 in collaboration with 21 22 U.S. Department of Energy Argonne National Laboratory 23 Environmental Assessment Division 24 Argonne, IL 60439 NOTICE This report is an external draft for review purposes only and does not constitute Agency policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. Review Draft: Do Not Cite or Quote Does Not Constitute EPA Policy ii TABLE OF CONTENTS Page LIST OF TABLES...........................................................................................................vii LIST OF FIGURES........................................................................................................ viii LIST OF TEXT BOXES ...................................................................................................xi LIST OF ABBREVIATIONS........................................................................................... xiii PREFACE .....................................................................................................................xvi AUTHORS, CONTRIBUTORS AND REVIEWERS ...................................................... xvii EXECUTIVE SUMMARY...............................................................................................xix 1. INTRODUCTION TO CUMULATIVE RISK AT THE U.S. EPA.......................... 1-1 1.1. PURPOSE AND SCOPE OF THIS REPORT ......................................... 1-2 1.1.1. Cumulative Risk Framework ........................................................ 1-5 1.1.2. Relationship to Other Programs and Documents......................... 1-8 1.1.3. Scope and Terminology ............................................................. 1-10 1.1.4. Report Organization................................................................... 1-15 1.2. EXAMPLES OF EXISTING U.S. EPA GUIDANCE............................... 1-16 1.2.1. Mixtures Risk Assessment......................................................... 1-19 1.2.2. Superfund Site Assessment....................................................... 1-20 1.2.3. Pesticide Group Cumulative Risk Assessment .......................... 1-21 1.3. OVERVIEW OF APPROACH TO CUMULATIVE HEALTH RISK ASSESSMENT FOR MULTIPLE CHEMICALS, PATHWAYS, TIMEFRAMES AND EFFECTS ............................................................ 1-22 1.3.1. Identify the Trigger for the Cumulative Risk Assessment........... 1-25 1.3.2. Characterize the Community and Population Based on the Trigger ................................................................................. 1-30 1.3.3. Generate Initial Chemical List .................................................... 1-30 1.3.4. Identify Links Between Chemicals and Subpopulations............. 1-32 1.3.5. Quantify Exposure for General Populations and Subpopulations .......................................................................... 1-33 1.3.6. Quantify Dose-response for Initial Toxicity Grouping................. 1-35 1.3.7. Integrate Exposure and Dose-response Information.................. 1-35 1.3.8. Conduct Risk Characterization................................................... 1-36 Review Draft: Do Not Cite or Quote Does Not Constitute EPA Policy iii TABLE OF CONTENTS cont. Page 2. INITIAL CHARACTERIZATION OF THE POPULATION AND CHEMICALS OF CONCERN............................................................................. 2-1 2.1. INITIAL DESCRIPTION OF THE POPULATION .................................... 2-1 2.1.1. Preliminary Characterization of the Population Based on the Trigger............................................................................... 2-2 2.1.2. Characteristics of Vulnerable Subpopulations ............................. 2-4 2.2. INITIAL ASSESSMENT OF EXPOSURE DATA..................................... 2-6 2.2.1. Initiating the Exposure Assessment when Health Endpoint is the Trigger................................................................................ 2-6 2.2.2. Initiating the Exposure Assessment when Elevated Chemical Concentrations are the Trigger .................................. 2-12 2.2.3. Initiating the Exposure Assessment when One or More Sources is the Trigger................................................................ 2-14 2.2.4. Summary ................................................................................... 2-16 2.3. LINKING THE LIST OF CHEMICALS OF CONCERN TO THE POPULATION PROFILE THROUGH A CONCEPTUAL MODEL......... 2-17 3. CUMULATIVE EXPOSURE ASSESSMENT ..................................................... 3-1 3.1. DEFINING CUMULATIVE EXPOSURE ASSESSMENT ........................ 3-2 3.2. EPA EXPOSURE ASSESSMENT GUIDANCE ...................................... 3-3 3.3. CUMULATIVE EXPOSURE ASSESSMENT: ANALYSIS PHASE.......... 3-4 3.3.1. Exposure Setting.......................................................................... 3-6 3.3.2. Exposure Pathways and Routes................................................ 3-12 3.3.3. Exposure Quantification............................................................. 3-48 3.4. ILLUSTRATION OF CUMULATIVE CONCEPTS FOR THE AIR PATHWAY AT A CONTAMINATED SITE............................................. 3-73 3.4.1. Emission Inventories.................................................................. 3-75 3.4.2. Dispersion Modeling .................................................................. 3-80 3.5. SUMMARY COMPARISON AND SCREENING SUGGESTIONS ........ 3-87 Review Draft: Do Not Cite or Quote Does Not Constitute EPA Policy iv TABLE OF CONTENTS cont. Page 4. CUMULATIVE TOXICITY ASSESSMENT ........................................................ 4-1 4.1. DEFINING CUMULATIVE TOXICITY ASSESSMENT............................ 4-2 4.2. U.S. EPA TOXICITY ASSESSMENT GUIDANCE.................................. 4-2 4.2.1. U.S. EPA Practices for Evaluating Chemical Mixtures................. 4-4 4.3. TOXICOLOGY OF INTERNAL CO-OCCURRENCE ............................ 4-11 4.4. CHEMICAL MIXTURES GROUPING AND TOXICITY ASSESSMENT SCHEME..................................................................... 4-17 4.4.1. Chemical Groupings by Common Effects .................................. 4-18 4.4.2. Refinement of Toxicity Groups................................................... 4-24 4.4.3. Cumulative Toxicity Assessment Scheme ................................. 4-28 4.4.4. Evaluating Subpopulations ........................................................ 4-31 4.5. EVALUATING MULTIPLE EFFECTS ................................................... 4-31 4.5.1. A Quantitative Method for Evaluating Multiple Effects ............... 4-32 4.5.2. Interpretation.............................................................................. 4-37 4.6. EVALUATING INTERACTION EFFECTS............................................. 4-37 4.6.1. Toxicology of Interactions .......................................................... 4-38 4.6.2. A Quantitative Method for Evaluating Interaction Effects........... 4-41 4.7. EVALUATING MULTIPLE ROUTE EXPOSURES................................ 4-45 4.7.1. Quantitative Approaches to Evaluating Multiple Route Exposures to Mixtures ............................................................... 4-46 4.7.2. Internal Dose Estimates............................................................. 4-51 4.8. SUMMARY RECOMMENDATIONS ..................................................... 4-52 5. CUMULATIVE RISK CHARACTERIZATION..................................................... 5-1 5.1. SPECIAL CONCERNS WITH CUMULATIVE RISK CHARACTERIZATION ........................................................................... 5-7 Review Draft: Do Not Cite or Quote Does Not Constitute EPA Policy v TABLE OF CONTENTS cont. Page 5.2. EXAMPLE EVALUATIONS OF QUANTITIATIVE APPROACHES TO CUMULATIVE RISK CHARACTERIZATION .................................. 5-10 5.2.1. Example Cumulative Risk Characterization: Cumulative Hazard Index ............................................................................. 5-10 5.2.2. Ordinal Regression Calculations for Multiple Effects and Pathways ............................................................................ 5-15 5.2.3. Combination of Exposures of Different Time Frames ................ 5-19 5.3. DESCRIPTION OF RESULTS.............................................................. 5-20 5.3.1. Risks for Population of Concern................................................. 5-21 5.3.2. Risks for Population Subgroups................................................. 5-23 5.3.3. Important Interaction Factors ..................................................... 5-23 5.4. DISCUSSION OF UNCERTAINTY ....................................................... 5-24 5.4.1. Environmental Media Concentrations and Population Contact ...................................................................................... 5-26 5.4.2. Dose-response Data.................................................................. 5-27 5.4.3. Multiplicity Issues with Exposures or Effects.............................. 5-28 5.4.4. Decision Steps in the Assessment Process............................... 5-28 5.5. SUMMARY RECOMMENDATIONS
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