United States Office of Water EPA 823-B-00-008 Environmental Protection (4305) November 2000 Agency Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 2 Risk Assessment and Fish Consumption Limits Third Edition Guidance for Assessing Chemical Contaminant Data for Use in Fish Advisories Volume 2: Risk Assessment and Fish Consumption Limits Third Edition Office of Science and Technology Office of Water U.S. Environmental Protection Agency Washington, DC United States Environmental Protection Agency (4305) Washington, DC 20460 Official Business Penalty for Private Use $300 Guidance for Assessing Chemical Contaminant Data for Use In Fish Advisories Volume 2: Risk Assessment and Fish Consumption Limits ACKNOWLEDGMENTS ACKNOWLEDGMENTS This report was prepared by the U.S. Environmental Protection Agency, Office of Water, Fish Contaminant Section. The EPA Work Assignment Manager for this document was Jeffrey Bigler who provided overall project coordination as well as technical direction. EPA was supported in the development of the third edition of this document by the Research Triangle Institute (RTI), Inc. (EPA Contract No. 68-C7-0056). Patricia Cunningham and Susan Goldhaber of RTI prepared this third edition. EPA was supported in the development of the original document by Abt Associates and Tetra Tech, Inc. Kathleen Cunningham of Abt Associates was the contractor’s Project Manager. Preparation of the first edition of this guidance document was facilitated by the substantial efforts of the numerous Workgroup members and reviewers (see Appendix A). xiii LIST OF ACRONYMS LIST OF ACRONYMS ACTH adrenocortical trophic hormone ARL acceptable lifetime risk level ATSDR Agency for Toxic Substances and Disease Registry BCF bioconcentration factor BW body weight CAG Carcinogenic Assessment Group CCRIS chemical carcinogenesis Research Information System CDDs chlorodibenzo-p-dioxins CDF chlorodibenzofurans CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CERCLIS CERCLA List of Sites CNS central nervous system COC chain-of-custody CR consumption rate CSF cancer slope factor DDD p,p1-dichlorodiphenyldichloroethane DDE p,p1-dichlorodiphenyldichloroethylene DDT p,p1-dichlorodiphenyltrichloroethane EPA U.S. Environmental Protection Agency FDA U.S. Food and Drug Administration FGDC Federal Geographic Data Committee FIFRA Federal Insecticide, Fungicide, and Rodenticide Act -BHC benzene hexachloride -HCH hexachlorocyclohexane GC/ECD gaschromatography/electron capture detection GC/MS gaschromatography/mass spectrometry GI gastrointestinal x LIST OF ACRONYMS GIS geographic information system GPS Global Positioning System HEAST Health Effects Assessment Summary Tables HRGC/HRMS high-resolution gas chromatography/high-resolution mass spectrometry HSDB Hazardous Substances Data Bank IRIS Integrated Risk Information System LD50 lethal dose, 50% kill LEL lowest exposure limit Llt luteinizing hormone LMS linearized multistage (model) LOAEL lowest observed adverse effects level LOD limit of detection MF modifying factor MFO mixed function oxidase MOE margin of exposure MS meal size NAS National Academy of Sciences NFTDR National Fish Tissue Data Repository NGO nongovernmental organization NHANES II National Health and Nutrition Examination Survey NIOSH National Institute of Occupational Safety and Health NLFWA National Listing of Fish and Wildlife Advisories NOAA National Oceanic and Atmospheric Administration NOAEL no observable adverse effect level NSCRF National Study of Chemical Residues in Fish NSDI National Spatial Data Infrastructure NTP National Toxicology Program OAPCA Organotin Antifouling Paint Control Act OPP Office of Pesticide Programs PAHs polycyclic aromatic hydrocarbons PCBs polychlorinated biphenyls PCDDs polychlorinated dibenzo-p-dioxins xi LIST OF ACRONYMS PCDFs polychlorinated dibenzofurans PCS Permit Compliance System PEC potency equivalency concentration PNAs polynuclear aromatic hydrocarbons POTW publically owned treatment works QA quality assurance QC quality control RAC reference ambient concentrations RBC red blood cell RCS Relative Source Contribution RDA recommended dietary allowance RfD reference dose RTECs Registry of Toxic Effects of Chemical Substances SAB Science Advisory Board SCE sister chromatid exchange SVs screening values 2,4,5-T 2,4,5-trichlorophenoxyacetic acid 2,3,7,8-TCDD 2,3,7,8-tetrachlorodibenzo-p-dioxin 2,3,7,8-TCDF 2,3,7,8-tetrachlorodibenzofuran 2,4,5-TCP 2,4,5-trichlorophenol TEC toxicity equivalent concentrations TRI Toxic Release Inventory UF uncertainty factor USDA U.S. Department of Agriculture USFWS U.S. Fish and Wildlife Service USGS U.S. Geological Survey WHO World Health Organization WOE weight of evidence xii TABLE OF CONTENTS TABLE OF CONTENTS Section Page List of Figures .............................................. vii List of Tables .............................................. viii List of Acronyms .............................................x Acknowledgments .......................................... xiii Executive Summary ......................................... xiv 1 Introduction ............................................... 1-1 1.1 Overview .............................................. 1-2 1.2 Objectives ............................................. 1-3 1.3 Sensitive Subpopulations ................................. 1-6 1.4 Contents of Volume 2 ................................... 1-10 1.5 Changes to Volume 2 ................................... 1-13 1.6 Sources .............................................. 1-14 2 Risk Assessment Methods .................................... 2-1 2.1 Introduction ............................................ 2-1 2.1.1 Other Information Sources .......................... 2-3 2.2 Hazard Identification ..................................... 2-4 2.2.1 Approach for Fish Contaminants ...................... 2-5 2.2.2 Assumptions and Uncertainty Analysis ................. 2-8 2.3 Dose-Response Assessment ............................. 2-10 2.3.1 Carcinogenic Effects .............................. 2-12 2.3.2 Noncarcinogenic Effects ........................... 2-13 2.3.3 Mutagenicity/Genotoxicity .......................... 2-19 2.3.4 Multiple Chemical Exposures: Interactive Effects ........ 2-20 2.3.5 Assumptions and Uncertainties ...................... 2-22 2.4 Exposure Assessment .................................. 2-25 2.4.1 Chemical Occurrences in Fish ....................... 2-25 2.4.2 Geographic Distribution of Contaminated Fish .......... 2-27 2.4.3 Individual Exposure Assessment ..................... 2-27 2.4.4 Population Exposure Assessments ................... 2-33 2.4.5 Uncertainty and Assumptions ....................... 2-39 2.5 Risk Characterization ................................... 2-49 2.5.1 Carcinogenic Toxicity ............................. 2-51 2.5.2 Noncarcinogenic Toxicity ........................... 2-52 2.5.3 Subpopulation Considerations ....................... 2-53 2.5.4 Multiple Species and Multiple Contaminant Considerations .................................. 2-55 iii TABLE OF CONTENTS Section Page 2.5.5 Incorporating Considerations of Uncertainty in Consumption Limits ............................... 2-55 2.6 Summarizing Risk Data .................................. 2-55 3 Development and Use of Risk-Based Consumption Limits ............ 3-1 3.1 Overview and Section Organization ......................... 3-1 3.2 Equations Used to Develop Risk-Based Consumption Limits ..................................... 3-2 3.2.1 Calculation of Consumption Limits for Carcinogenic Effects ............................... 3-2 3.2.2 Calculation of Consumption Limits for Noncarcinogenic Effects ............................ 3-7 3.2.3 Developmental Effects .............................. 3-8 3.3 Default and Alternative Values for Calculating Consumption Limits ................................................ 3-9 3.3.1 Maximum Acceptable Risk Level ..................... 3-10 3.3.2 Cancer Potencies and Chronic Reference Doses (q1*s and RfDs) .................................. 3-11 3.3.3 Consumer Body Weight (BW) ....................... 3-11 3.3.4 Meal Size ...................................... 3-12 3.3.5 Contaminant Concentration in Fish Tissue ............. 3-14 3.3.6 Modifying Time-Averaging Period (Tap) ................ 3-14 3.4 Modification of Consumption Limits for a Single Contaminant in a Multispecies Diet ................... 3-15 3.4.1 Carcinogenic Effects .............................. 3-15 3.4.2 Noncarcinogenic Effects ........................... 3-16 3.5 Modification of Consumption Limits for Multiple Contaminant Exposures ........................... 3-17 3.5.1 Carcinogenic Effects .............................. 3-19 3.5.2 Noncarcinogenic Effects ........................... 3-20 3.5.3 Species-Specific Consumption Limits in a Multiple Species Diet .................................... 3-22 4 Risk-Based Consumption Limit Tables ........................... 4-1 4.1 Overview and Section Organization ......................... 4-1 4.2 Consumption Limit Tables ................................. 4-2 5 Toxicological Profile Summaries for Target Analytes ................ 5-1 5.1 Introduction ............................................ 5-1 5.1.1 Categories of Information Provided for Target Analytes .... 5-1 5.1.2 Abbreviations Used and Scientific Notation .............. 5-8 5.2 Metals ................................................ 5-9 5.2.1 Arsenic ......................................... 5-9 5.2.2 Cadmium