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Systematic Review Protocol for the Vanadium and Compounds (Oral Exposure) IRIS Assessment

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Systematic Review Protocol for the Vanadium and Compounds (Oral Exposure) IRIS Assessment [EPA/635/R-21/047] IRIS Assessment Protocol www.epa.gov/iris Systematic Review Protocol for the Vanadium and Compounds (Oral Exposure) IRIS Assessment (Preliminary Assessment Materials) April 2021 Integrated Risk Information System Center for Public Health and Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Washington, DC Systematic Review Protocol for the Vanadium and Compounds (Oral) IRIS Assessment DISCLAIMER This document is a public comment draft for review purposes only. This information is distributed solely for the purpose of public comment. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use. This document is a draft for review purposes only and does not constitute Agency policy. ii DRAFT―DO NOT CITE OR QUOTE Systematic Review Protocol for the Vanadium and Compounds (Oral) IRIS Assessment CONTENTS CONTENTS .................................................................................................................................................... iii AUTHORS | CONTRIBUTORS | REVIEWERS ................................................................................................... ix 1. INTRODUCTION ...................................................................................................................................... 1 2. SCOPING AND INITIAL PROBLEM FORMULATION SUMMARY ............................................................... 3 2.1. BACKGROUND ................................................................................................................................ 3 2.1.1. Sources, Production, and Use............................................................................................... 3 2.1.2. Physical and Chemical Properties ......................................................................................... 4 2.1.3. Environmental Fate and Transport .................................................................................... 10 2.1.4. Potential for Human Exposure (Oral) ................................................................................. 10 2.1.5. Previous Assessments of Oral Exposure to Vanadium and Compounds by the Environmental Protection Agency and Other Health Agencies ......................................... 11 2.2. SCOPING SUMMARY .................................................................................................................... 18 2.3. PROBLEM FORMULATION ............................................................................................................ 18 2.4. LITERATURE INVENTORY RESULTS ............................................................................................... 19 2.4.1. Human Studies Meeting PECO Criteria .............................................................................. 19 2.4.2. Animal Studies Meeting PECO Criteria ............................................................................... 24 2.4.3. Studies in Progress by the National Toxicology Program ................................................... 33 2.4.4. Comparison with Studies Used in the 1987 IRIS Assessment ............................................ 34 2.4.5. Literature Inventory Summary ........................................................................................... 34 2.5. KEY SCIENCE ISSUES ..................................................................................................................... 37 3. OVERALL OBJECTIVES, SPECIFIC AIMS, AND POPULATIONS, EXPOSURES, COMPARATORS, AND OUTCOMES (PECO) CRITERIA ....................................................................................................... 38 3.1. SPECIFIC AIMS .............................................................................................................................. 38 3.2. POPULATIONS, EXPOSURES, COMPARATORS, AND OUTCOMES CRITERIA ................................. 39 4. LITERATURE SEARCH AND SCREENING STRATEGIES ............................................................................ 45 4.1. USE OF EXISTING ASSESSMENTS .................................................................................................. 45 4.2. LITERATURE SEARCH STRATEGIES ................................................................................................ 45 4.2.1. Database Searches ............................................................................................................. 45 4.2.2. Other Resources Consulted ................................................................................................ 46 4.3. INCLUSION OF NONPUBLIC AND NONPEER-REVIEWED DATA ..................................................... 48 This document is a draft for review purposes only and does not constitute Agency policy. iii DRAFT―DO NOT CITE OR QUOTE Systematic Review Protocol for the Vanadium and Compounds (Oral) IRIS Assessment 4.4. LITERATURE SCREENING STRATEGY ............................................................................................. 49 4.4.1. Multiple Publications of the Same Data ............................................................................. 50 4.4.2. Literature Flow Diagram ..................................................................................................... 50 4.5. SUMMARY-LEVEL LITERATURE INVENTORIES .............................................................................. 52 5. REFINED EVALUATION PLAN ................................................................................................................ 53 6. STUDY EVALUATION (REPORTING, RISK OF BIAS, AND SENSITIVITY) STRATEGY ................................. 55 6.1. STUDY EVALUATION OVERVIEW FOR HEALTH EFFECT STUDIES .................................................. 55 6.2. EPIDEMIOLOGY STUDY EVALUATION ........................................................................................... 59 6.2.1. Epidemiological Study Evaluation Considerations Specific to Vanadium .......................... 69 6.3. EXPERIMENTAL ANIMAL STUDY EVALUATION ............................................................................. 72 6.3.1. Animal Toxicology Study Evaluation Considerations Specific to Vanadium ....................... 83 6.4. HUMAN CLINICAL TRIAL STUDY EVALUATION ............................................................................. 84 6.5. PHYSIOLOGICALLY BASED PHARMACOKINETIC MODEL DESCRIPTIVE SUMMARY AND EVALUATION ................................................................................................................................. 85 6.6. MECHANISTIC STUDY EVALUATION ............................................................................................. 85 7. ORGANIZING THE HAZARD REVIEW ..................................................................................................... 97 8. DATA EXTRACTION OF STUDY METHODS AND RESULTS .................................................................... 100 8.1. STANDARDIZING REPORTING OF EFFECT SIZES .......................................................................... 101 8.2. STANDARDIZING ADMINISTERED DOSE LEVELS/CONCENTRATIONS ......................................... 101 9. SYNTHESIS WITHIN LINES OF EVIDENCE ............................................................................................. 102 9.1. SYNTHESES OF HUMAN AND ANIMAL HEALTH EFFECTS EVIDENCE .......................................... 106 9.2. MECHANISTIC INFORMATION .................................................................................................... 107 10. INTEGRATION ACROSS LINES OF EVIDENCE ....................................................................................... 115 10.1. INTEGRATION WITHIN THE HUMAN AND ANIMAL EVIDENCE ................................................... 119 10.2. OVERALL EVIDENCE INTEGRATION CONCLUSIONS .................................................................... 127 10.3. HAZARD CONSIDERATIONS FOR DOSE-RESPONSE ..................................................................... 131 11. DOSE-RESPONSE ASSESSMENT: STUDY SELECTION AND QUANTITATIVE ANALYSIS ......................... 134 11.1. SELECTING STUDIES FOR DOSE-RESPONSE ASSESSMENT .......................................................... 135 11.2. CONDUCTING DOSE-RESPONSE ASSESSMENTS ......................................................................... 138 11.2.1. Dose-response Analysis in the Range of Observation ...................................................... 138 11.2.2. Extrapolation: Slope Factors ............................................................................................. 140 11.2.3. Extrapolation: Reference Values ...................................................................................... 140 REFERENCES .............................................................................................................................................. 143 This document is a draft for review purposes only and does not constitute Agency policy. iv DRAFT―DO NOT CITE OR QUOTE Systematic Review Protocol for the Vanadium and Compounds (Oral) IRIS Assessment APPENDICES .............................................................................................................................................. 152 APPENDIX A. SURVEY OF EXISTING VANADIUM ORAL TOXICITY VALUES ........................................
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