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Drinking Water Health Advisory for the Cyanobacterial Toxin Cylindrospermopsin

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Drinking Water Health Advisory for the Cyanobacterial Toxin Cylindrospermopsin United States Office of Water EPA- 820R15101 Environmental Mail Code 4304T June 2015 Protection Agency Drinking Water Health Advisory for the Cyanobacterial Toxin Cylindrospermopsin Drinking Water Health Advisory for the Cyanobacterial Toxin Cylindrospermopsin Prepared by: U.S. Environmental Protection Agency Office of Water (4304T) Health and Ecological Criteria Division Washington, DC 20460 EPA Document Number: 820R15101 Date: June 15, 2015 ACKNOWLEDGMENTS This document was prepared by U.S. EPA Scientists Lesley V. D’Anglada, Dr.P.H. (lead) and Jamie Strong, Ph.D. Health and Ecological Criteria Division, Office of Science and Technology, Office of Water. EPA gratefully acknowledges the valuable contributions from Health Canada’s Water and Air Quality Bureau, in developing the Analytical Methods and Treatment Technologies information included in this document. This Health Advisory was provided for review and comments were received from staff in the following U.S. EPA Program Offices: U.S. EPA Office of Ground Water and Drinking Water U.S. EPA Office of Science and Technology U.S. EPA Office of Research and Development U.S. EPA Office of Children’s Health Protection U.S. EPA Office of General Counsel This Health Advisory was provided for review and comments were received from the following other federal and health agencies: Health Canada U.S. Department of Health and Human Services, Centers for Disease Control and Prevention Drinking Water Health Advisory for Cylindrospermopsin - June 2015 i TABLE OF CONTENTS ACKNOWLEDGMENTS.....................................................................................................................I TABLE OF CONTENTS .................................................................................................................... II LIST OF TABLES..............................................................................................................................IV LIST OF FIGURES ............................................................................................................................IV ABBREVIATIONS AND ACRONYMS .......................................................................................... V EXECUTIVE SUMMARY.................................................................................................................. 1 1.0 INTRODUCTION AND BACKGROUND ........................................................................... 3 1.1 Current Criteria, Guidance and Standards .......................................................................... 3 2.0 PROBLEM FORMULATION ................................................................................................ 5 2.1 Cyanobacteria and Production of Cylindrospermopsin ..................................................... 5 2.2 Physical and Chemical Properties ....................................................................................... 5 2.3 Sources and Occurrence ...................................................................................................... 7 2.3.1 Occurrence in Surface Water ...................................................................................... 8 2.3.2 Occurrence in Drinking Water .................................................................................... 8 2.4 Environmental Fate .............................................................................................................. 9 2.4.1 Persistence .................................................................................................................... 9 2.4.2 Mobility ........................................................................................................................ 9 2.5 Nature of the Cylindrospermopsin Toxin ........................................................................... 9 2.5.1 Toxicokinetics .............................................................................................................. 9 2.5.2 Noncancer Health Effects Data ................................................................................. 10 2.5.3 Mode of Action for Noncancer Health Effects ........................................................ 11 2.5.4 Carcinogenicity Data ................................................................................................. 12 2.6 Conceptual Model .............................................................................................................. 12 2.6.1 Conceptual Model Diagram ...................................................................................... 15 2.6.2 Factors Considered in the Conceptual Model for Cylindrospermopsin ................. 15 2.7 Analysis Plan ...................................................................................................................... 16 3.0 HEALTH EFFECTS ASSESSMENT .................................................................................. 19 3.1 Dose-Response ................................................................................................................... 19 3.1.1 Critical Study Selected .............................................................................................. 19 3.1.2 Endpoint Selection ..................................................................................................... 22 3.2 Ten-Day Health Advisory ................................................................................................. 23 3.2.1 Bottle-fed Infants and Young Children of Pre-school Age ..................................... 23 3.2.2 School-age Children through Adults ........................................................................ 24 3.2.3 Uncertainty Factor Application................................................................................. 24 4.0 RISK CHARACTERIZATION ............................................................................................ 26 4.1 Studies Supporting Determination of Critical Study ....................................................... 26 4.2 Study Duration ................................................................................................................... 26 4.3 Allometric Scaling Approach ............................................................................................ 27 Drinking Water Health Advisory for Cylindrospermopsin - June 2015 ii 4.4 Uncertainty and Variability ............................................................................................... 27 4.5 Susceptibility ...................................................................................................................... 28 4.6 Distribution of Body Weight and Drinking Water Intake by Age .................................. 28 4.7 Distribution of Potential Health Advisory Values by Age .............................................. 29 5.0 ANALYTICAL METHODS ................................................................................................. 31 6.0 TREATMENT TECHNOLOGIES ....................................................................................... 32 6.1 Management and Mitigation of Cyanobacterial Blooms in Source Water..................... 32 6.2 Drinking Water Treatment................................................................................................. 33 6.2.1 Conventional Treatment for Cylindrospermopsin ................................................... 33 6.2.2 Chemical Oxidation ................................................................................................... 34 6.2.3 Ultraviolet Irradiation ................................................................................................ 35 6.3 Point-of-Use (POU) Drinking Water Treatment Units .................................................... 35 7.0 REFERENCES ....................................................................................................................... 36 Drinking Water Health Advisory for Cylindrospermopsin - June 2015 iii LIST OF TABLES Table 1-1. International Guideline Values for Cylindrospermopsin ................................................ 4 Table 1-2. State Guideline Values for Cylindrospermopsin .............................................................. 4 Table 2-1. Chemical and Physical Properties of Cylindrospermopsin .............................................. 7 Table 3-1. Kidney Weight Data from Oral Toxicity Study of Cylindrospermopsin Administered Daily over Eleven Weeks (Humpage and Falconer, 2002, 2003) ........................................... 21 Table 3-2. Selected Clinical Chemistry, Hematology and Urinalysis Findings (Humpage and Falconer, 2002, 2003) ................................................................................................................ 21 LIST OF FIGURES Figure 2-1. Structure of Cylindrospermopsin (de la Cruz et al., 2013) ............................................. 6 Figure 2-2. Structurally Related Cylindrospermopsins (de la Cruz et al., 2013) ............................. 6 Figure 2-3. Conceptual Model of Exposure Pathways to Cylindrospermopsin in Drinking Water ..................................................................................................................................................... 14 Figure 4-1. 90th Percentile Drinking Water Ingestion Rates by Age Group ................................... 29 Figure 4-2. Ten-day Health Advisories for Cylindrospermopsin by Age Group ........................... 30 Drinking Water Health Advisory for Cylindrospermopsin - June 2015 iv ABBREVIATIONS AND ACRONYMS
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