Water Research Foundation Expert Workshop on EDCs/PPCPs in Drinking Water Summary Introduction Addressing endocrine disrupting compounds (EDCs) and pharmaceuticals and personal care products (PPCPs) in drinking waters is a significant challenge for water utilities because of the low concentrations at which they occur, the lack of definitive information on potential human health effects at these concentrations, and overall concern about the issue. To help utilities better understand and address the issue, the Water Research Foundation (WaterRF) has funded research on analytical methods, monitoring, treatment, and risk communication for EDCs and PPCPs. There has also been extensive research funded and conducted in recent years by many other research organizations, and the water industry would benefit from a coordinated path forward. To this end, WaterRF held an expert workshop in Denver, Colorado September 7-8, 2011 to discuss recent and ongoing related research activities, identify remaining challenges in this area, and generate a priority list of research needs that would most benefit the industry. Focus areas considered included occurrence, monitoring, measurement, risk assessment, risk communication, control, and treatment. Representatives from drinking water utilities, academia, consulting, research, federal agencies, and international organizations attended this workshop. Workshop Participants Anna Durden, WateReuse Foundation Ben Blount, Centers for Disease Control Brett Vanderford, Southern Nevada Water Authority Christopher Weis, National Institute of Environmental Health Sciences Daniel Quintanar, City of Tucson Water Department Elisabeth Hawley, Malcolm Pirnie/ARCADIS Eric Dickenson, Southern Nevada Water Authority Erik Rosenfeldt, Hazen and Sawyer Frederick vom Saal, University of Missouri – Columbia Herb Buxton, U.S. Geological Survey James Kopp, City of St. Louis Water Division Jeanne Bailey, Fairfax Water John Gordon, Alion Science and Technology Jörg Drewes, Colorado School of Mines Laura Kennedy, Kennedy/Jenks Consultants Lisa Ragain, Aqua Vitae Lola Olabode, Water Environment Research Foundation Melissa Rothrock, Texas Commission on Environmental Quality Mohammad Habibian, Washington Suburban Sanitary Commission Patti Fauver, Utah Department of Environmental Quality (representing Association of State Drinking Water Agencies) Paul Westerhoff, Arizona State University Phillippe Daniel, CDM Rafael Terrero, Miami Dade Water and Sewer Department Rengao Song, Louisville Water Company Richard Pleus, Intertox, Inc. Richard Sakaji, East Bay Municipal Utility District Rino Trolio, Water Corporation (representing Water Services Association of Australia) Shahram Tabe, Ontario Ministry of the Environment Shane Snyder, University of Arizona Susan Andrews, University of Toronto (representing Canadian Water Network) Susan Glassmeyer, U.S. Environmental Protection Agency Zaid Chowdhury, Malcolm Pirnie/ARCADIS Alice Fulmer, Water Research Foundation Hsiao-wen Chen, Water Research Foundation John Albert, Water Research Foundation Linda Reekie, Water Research Foundation Agenda Wednesday, September 7 12:00 noon Lunch provided / Informal meet and greet 1:00 pm Welcome, Workshop Objectives, and Introductions (Alice Fulmer) 1:30 pm Organizational Overviews of Recent, Ongoing, and Planned EDC/PPCP Research Water Research Foundation (Rick Sakaji, East Bay Municipal Utility District) WateReuse Research Foundation (Anna Durden) Water Environment Research Foundation (Lola Olabode) Water Services Association of Australia (Rino Trolio, Water Corporation) Canadian Water Network (Susan Andrews, University of Toronto) U.S. Geological Survey (Herb Buxton) U.S. Environmental Protection Agency (Susan Glassmeyer) Centers for Disease Control (Ben Blount) 3:30 pm Presentations on Health Effects of EDCs/PPCPs Toxicology (Christopher Weis, National Institute for Environmental Health Sciences) Endocrinology (Frederick vom Saal, University of Missouri – Columbia) 4:30 pm Discussion of Remaining Knowledge Gaps and Identification of Focus Areas in Need of Research 5:30 pm Adjourn 6:30 pm Gather in hotel lobby for dinner Thursday, September 8 7:30 am Breakfast provided 8:00 am Recap of Day 1, Breakout Group Topics and Assignments 8:30 am Breakout Group Discussions of Specific Research Needs in Identified Focus Areas 10:30 am Break 10:45 am Group Rotations to Provide Feedback 11:30 am 12:00 pm 1:00 pm 2:00 pm Breakout Groups Reconvene to Incorporate Feedback Lunch provided Full Group Discussions to Prioritize Focus Areas Next Steps / Adjourn Focus Areas, Related Research, and Remaining Research Needs Following presentations summarizing recent and ongoing research on EDCs and PPCPs, workshop participants identified four main areas that still present significant challenges for the water industry with regard to EDCs and PPCPs and for which focused research would help: Risk Communication Monitoring Techniques Holistic Control Strategies Risk Assessment Recent and ongoing research related to each of these areas was compiled based on the presentations. With this information, participants worked in breakout groups to develop problem statements and goals for each suggested focus area and identify priority research needs to help meet the goals. Participants then circulated to listen to the recommendations and provide feedback. Afterward, relative priority was discussed. While all four topics were deemed important, workshop participants representing drinking water utilities identified risk communication and holistic control strategies as their top priorities. The related research projects and remaining research needs identified for the four suggested focus areas are presented on the following pages. Risk Communication – Developing Core Messages and Engaging Critical Stakeholders Related Research (WaterRF 4169) Water Utility Framework for Responding to Emerging Contaminant Issues (WaterRF 4261) Building a National Utility Network to Address EDC/PPCP Issues (WaterRF 4323) Consumer Perceptions and Attitudes towards EDCs and PPCPs in Drinking Water (WaterRF 4387) Development of a Water Utility Handbook on EDCs/PPCPs for Public Education and Consumption (WERF CEC3R07) Technical Brief - Trace Organics and Implications for Wastewater Treatment and Receiving Waters (WERF) Communication Principles and Practices, Public Perception, and Message Effectiveness (WERF 00PUM1) Water Reuse: Understanding Public Perception and Participation (WERF 00PUM5) Public Perception of Biosolids Recycling: Developing Public Participation and Earning Trust (WRF-07-03) Talking about Water: Vocabulary and Images that Support Informed Decisions about Water Recycling and Desalination (WRF-09-07) The PPCP Communications Toolkit Problem Statement Communicating to diverse stakeholders about the risk of exposure to chemicals of emerging concern (CECs) that are detected in source or treated drinking water is a challenge for water utilities. The challenge arises because the risks to human health are frequently not known and the science informing these risks is evolving. In addition, analytical techniques continue to improve, so that increasingly smaller levels of CECs are able to be detected. With an increased stakeholder access to information (and misinformation), drinking water utilities must be proactive in communicating what they know and don’t know when third parties report on occurrence or frequency of CECs in a utility’s water source or treated water. Risk communication messages tailored to reach different audiences and delivered using appropriate mechanisms must be readily available to assist water utilities in these critical communications. Effective communications can improve customer and stakeholder trust of and support for a water utility. Furthermore, drinking water utilities recognize that they have been thrust into a role that they are not necessarily qualified to address nor able to resolve. Drinking water utilities have no control over the new chemicals that are manufactured, marketed, consumed and disposed or transported into source waters from source and non-point sources. However, since water utilities are the local entity that provides the product, water, to the customer, they are often perceived by their customers as being the entity responsible for the presence and complete removal of the contaminant. The issue is further compounded by improved analytical techniques that allow scientists to find increasingly smaller quantities of contaminants in water, and the difficulty and long period of time required to establish impacts of exposure on humans. There is a need for the initiation of a national dialogue that includes a discussion among a broad and diverse group of stakeholders, including (but not limited to) representatives from chemical manufacturers, large users of CECs, non-governmental environmental organizations, federal environmental management and health agencies, water quality researchers, toxicologists, elected officials, wastewater utilities, and water utilities. The dialogue would assist in identifying the range of issues associated with CECs, the similar and different drivers and goals for the various stakeholders, and areas where stakeholders could agree to cooperate or collaborate to reach common goals. This would help assist water utilities in their communications that the solutions to the issues associated with CECs are issues that are the responsibility of many stakeholders. Goals 1. Provide core messages for water utilities to communicate the relative risk of exposure to CECs in water to different audiences. 2. Initiate a national dialogue with a broad range of stakeholders to agree on issues associated with CECs in drinking water; discuss multi-disciplinary, multi-sector solutions; and identify frameworks and opportunities for continued discussions towards solutions. Projects/Types of Projects Needed to Achieve Goals 1. Develop key core messages for the water and wastewater utilities to communicate about CECs to various stakeholders. The following is a list of important aspects of the project: a. Involve water and wastewater utilities (chief executive officers, managers, engineers, public affairs officers), various scientific disciplines (social scientists, chemists, toxicologists), regulators, health officials, communication specialists, customers, regulators to develop messages. b. Define relative risk, absolute risk, comparative risk and other common riskscience terminology. Characterize the differences of relative risk vs. absolute risk (and other common risk-related terms) and the implications of their use in communications. c. Discuss exposure to other risks from drinking water (i.e., microbial risk). d. Identify, compare, and contrast the range of environmental exposures to CECs. e. Evaluate the value and outcome of communications that make comparisons between exposure to CECs from drinking water and exposure to CECs from other sources. f. Develop core messages with input from key stakeholder representatives. Some examples include how to communicate the value of water, pride of community water supply, relative risks, changing science, uncertainty of health effects, the connection of water to wastewater, public responsibility, etc. g. Develop tailored messages for different audiences (e.g., vulnerable populations, non-English speaking populations, elected officials, regulators, etc.) h. Investigate and discuss how to deliver messages that counter negative messages and result in positive perceptions i. Discuss conscious use and avoidance of certain words in messages. j. Explore the use of info-graphics in communicating concepts (i.e., portray a hierarchy of drinking water violations or risks using a pyramid.) k. Frame risk in terms of public health; investigate tailoring messages for different endpoints. l. Explore the impact of using various messengers and organizations (i.e., elected official vs. regulator vs. public health official.) m. Investigate different perceptions of acceptable risk for different audiences (i.e., public, regulator) n. Identify strategies to counter a message if it is shown to be incorrect. o. Identify the diverse sources of environmental exposures to CECs. p. Prepare a guide to help utilities talk about the difference between research methods and regulatory methods and the implications of each. What are the components that are needed to inform policy and regulations. “Science happens” and here is what we know. q. Develop some criteria for utilities to use to select various communication strategies and tools for various purposes and audiences. r. Identify metrics to measure the impacts of communications on target audiences. s. Evaluate impacts of communications on target audience. t. The development of messages will lead to identification of additional research needs, as gaps in data and knowledge are identified (i.e., the researcher will discover that the data, information or knowledge needed to put the messages together is not yet available.) 2. Convene a series of facilitated workshops to begin a dialogue with a broad range of stakeholders on the issue of CECs in drinking water and to discuss multi-disciplinary, multi-sector solutions. Estimated Timeframe to Achieve Goals 2 years Monitoring Techniques for EDCs and PPCPs Related Research (WaterRF 4167) Evaluation of Analytical Methods for EDCs and PPCPs via InterLaboratory Comparison (SI, 2008) (WaterRF 4193) Detection and Quantification of EDC/PPCPs in Source Waters Containing Dissolved and Colloidal Organic Matter (WaterRF 4260) Benchmarking and Monitoring Strategies for EDCs/PPCPs by Drinking Water Utilities (WRF-05-005) Identifying Hormonally Active Compounds, Pharmaceuticals, and Personal Care Product Ingredients of Health Concern from Potential Presence in Water Intended for Indirect Potable Reuse (WERF) Development of Indicators and Surrogates for Chemical Contaminant Removal during Wastewater Treatment and Reclamation (WERF) Diagnostic Tools to Evaluate Impacts of Trace Organic Compounds (WERF/TZW) Tools for Analyzing Estrogenicity in Environmental Waters (TZW) Evaluation and Application of the YES-Assay for the Detection of EDCs including Biodegradation Studies (KWR) Relating environmental concentrations of pharmaceuticals to consumption: a mass balance approach for the river Rhine (KWR) Detection of multiple hormonal activities in wastewater effluents and surface water, using a panel of steroid receptor CALUX bioassays (KWR) Temporal variation in multiple hormonal activities of surface waters located in the Dutch part of the Rhine basin (GWRC – WaterRF 4407) Tools for Analyzing Androgenic, Thyroid, Glucocorticoid, and Progestagenic Activity in Environmental Waters - Literature Review (GWRC) In Vitro Bioassays to Detect Estrogenic Activity in Environmental Waters (GWRC) Development of a Priority List of Pharmaceuticals (USGS) National monitoring of environmental contaminants (EPA) Method Development Based on Prioritized Compounds (EPA) National rivers and streams assessment (EPA) Strategic effluent sampling for CECs (EPA) CECs in Untreated and Treated Drinking Water (WSAA) Collaborative Research Project – use of indicators Problem Statement While analytical techniques for measuring chemicals have improved, monitoring for EDCs and PPCPs in water remains a challenge due to a number of factors. First, there are a broad number of relevant compounds, and watershed inputs vary, therefore it is difficult to determine what compounds to monitor to generate results that are both widely comparable and relevant for specific sites. Also, EDC/PPCP concentrations vary with time, making it difficult to know whether sampling events are representative of typical concentrations. Moving forward, experts believe that future sampling strategies should pair chemical analyses with bioassays for best results, because bioassays can capture effects of unknown compounds and mixtures. However, there are questions regarding the reliability and interpretation of bioassays. For these reasons, utilities would benefit from guidance regarding what EDCs/PPCPs to monitor, when and how frequently to monitor, and how to incorporate bioassays into monitoring strategies. Goals 1. Develop monitoring guidance that includes priority EDCs and PPCPs compounds for different monitoring purposes and monitoring frequency necessary for representative results. 2. Further the quality, reliability, application, and interpretation of bioassays as water quality monitoring tools. Projects/Types of Projects Needed to Achieve Goals 1. Identification of and consensus regarding target CECs to be investigated for different purposes in different situations, including surrogates for classes of CECs and treatment performance indicators ($75,000 for a 2-day workshop – same need identified for Holistic Control Strategies focus area) 2. Workshop to identify criteria and standards to be met for validation of bioassays, including those for non-estrogenic endpoints, but learning from analytical issues from estrogenic assays. Deliverables should include a white paper for utilities to inform them of how to interpret results. ($50,000) 3. Round robin to compare performance of bioassays ($200,000 if add drinking water relevant matrices to existing WateReuse Foundation project) 4. Conduct case studies of utilities with different online sensors to investigate temporal variations in EDCs/PPCPs and compare concentrations to grab samples to determine (a) the application of online sensors for EDCs and PPCPs and (b) the sampling frequencies and strategies needed to capture representative samples ($500,000) Estimated Timeframe to Achieve Goals 4 years Holistic Control Strategies for Managing Chemicals of Emerging Concern in Drinking Water Related Research (WaterRF 4386) Decision Support Program for Reducing EDCs and PPCPs in Drinking Water (WaterRF 4396, WQRA) Transformation Chemistry of EDCs/PPCPs Resulting from the Disinfection of Drinking Water (WaterRF 4176) Developing a Vision and Roadmap for Source Water Protection for U.S. Drinking Water Utilities (WaterRF 4334, WERF) Constructed Wetlands for Treatment of Organic and Nonmaterial Pollutants (WaterRF 4168) Qualitative Structure Property Relationships (QSPR) to Predict Removal of EDC/PPCPs in Water Treatment Processes (WERF) Development of Indicators and Surrogates for Chemical Contaminant Removal during Wastewater Treatment and Reclamation (WERF) Developing a Standardized Protocol for Assessing the Biodegradability of Trace Organic Contaminants (WERF) Treatability Research Plan (TZW) Identification and und assessment of selected pharmaceuticals and their metabolites (degradation and transformation products) in the water cycle (TZW) Integrated Water Resources Management (IWRM) in the lower Jordan Rift Valley, Sustainable Management of Available Water Resources with Innovative Technologies (CWN EC-2) Determining the efficacy of EC removal in existing treatment trains relevant to Canadian conditions through chemical and toxicological assessments (EPA) Formation of Iodo-DBPs from X-ray Contrast Media Several projects (too numerous to list) have looked at efficacy of membrane treatment, adsorption processes, UV oxidation, ozone, and other advanced treatment techniques in addition to riverbank filtration for EDC/PPCP removal from wastewater and drinking water Problem Statement Chemicals of emerging concern (CECs, including EDCs and PPCPs) enter watersheds through point and non-point sources. The connection between sources and drinking water is not fully understood, and there are still many unknowns. Better understanding this connection would help identify optimal control strategies. While there is no 100 percent barrier for CECs, there are advantages and disadvantages of various control strategies, including watershed management strategies, centralized drinking water treatment, or even POE/POU treatment. The water industry and society would benefit from holistic strategies for reducing risk from exposure to CECs that maximize ecological and health benefits while minimizing the financial and environmental costs of doing so. This is consistent with EPA’s new Drinking Water Strategy goal to use the authority of multiple statutes to help protect drinking water. Goals Understand sources and temporal variability of CECs to inform control strategies Develop holistic approaches for reducing exposure to CECs in drinking water that consider the sources and variability of CECs, end uses of water, and the financial, environmental, and social costs/benefits of different, emerging approaches Projects/Types of Projects Needed to Achieve Goals 1. Identification of and consensus regarding target CECs to be investigated for different purposes, including surrogates for classes of CECs and treatment performance indicators ($75,000 – same need identified for Monitoring focus area) 2. Strategies for developing treatment goals (desired water quality) for CECs, considering acceptable risk (based on regulatory, health science, public perception), affordability, and other factors ($150,000) 3. Strategies for adopting holistic source management and treatment for CECs, considering simultaneous compliance and possible changes in regulations, policy, and community practices ($400,000) 4. Evaluation of treatment targeted to end-use type, including POE/POU treatment efficiency of existing devices, development of new devices, regulatory considerations, deployment, maintenance, and cost, etc ($500,000) 5. Monitoring of targeted CECs in watersheds and investigation of fate and transport under different geochemical and hydrological conditions ($500,000) 6. Comprehensive analysis of the effectiveness and financial, environmental, and social costs/benefits of the various control strategies identified under different conditions and development of recommendations for best management practices under different conditions ($250,000) Estimated Timeframe to Achieve Goals 5-7 years Risk Assessment of Chemicals of Emerging Concern Related Research (WaterRF 4214) Development of Acceptable Daily Intakes (ADIs) for PPCP Ingredients, Hormonally Active Compounds, and Other Potentially Highly Toxic Compounds of Emerging Interest in Water Using the Minimum Anticipated Biological Effect Level (MABEL) Approach (WaterRF 3085) Toxicological Relevance of Endocrine Disruptors and Pharmaceuticals in Drinking Water (WRF-06-018) Tools to Assess and Understand the Relative Risks of Indirect Potable Reuse and Aquifer Storage and Recovery Project (WRF-06-004) Identifying health effects of water reuse industry and prioritizing research needs for nomination of chemicals for research to appropriate national and international agencies (WRF-09-07) Risk Assessment Study of PPCPs in Recycled Water to Support Public Review (Published as “The PPCPs Communications Toolkit”) (KWR) Development of in vitro toxicity tests, implementation and interpretation of the test results towards significance for human health (WQRA) A National Approach to the Health Risk Assessment, Risk Communication and Management of Chemical Hazards from Recycled Water Project (WERF) Diagnostic Tools to Evaluate Impacts of Trace Organic Compounds on Aquatic Populations and Communities (TZW) Preventive risk assessment on pathogens and micro-pollutants for drinking water utilities (CWN EC-1) Assessing impacts on aquatic organisms exposed to ECs in MWWEs (CDC) Human Biomonitoring and Investigation of Thyroid-Active Chemicals as part of National Health and Nutrition Examination Survey (NHANES) (NIEHS) Multiple projects related to Developmental Basis of Disease: Environmental Exposure and Epigenetics (NIEHS) New Approaches to Hazard and Dose-Response Analysis for Endocrine Disrupting Chemicals Problem Statement CECs will always be an issue. There is a need for a process for identifying the most probable CECs to be found in water and assessing the risk of CECs now and into the future (unknown chemicals, mixtures, or current CECs with new modes of action (MOA)) and placing them into a relative risk framework. To this end, the risk assessment process needs to evolve to incorporate new understandings and the mechanisms current science has identified. Background The discussions at the workshop highlighted that risk assessment process, as it stands now, is not adequate given the vast advances in science. We now have a better understanding of MOA as well as increased analytical sensitivities. Risk Assessment components include: 1. Hazard Assessment 2. Exposure Assessment 3. Dose-Response 4. Risk Characterization Goals & Projects/Types of Projects Needed to Achieve Goals 1. Determine Relative Risk a. Compare to microbial risk assessment b. Compare to other sources c. Keep units the same 2. Identify CECs that are most probable to be in water sources a. Either individual or classes of CEC (this overlaps with the Monitoring focus area) b. Identify risk management strategies that would be best for mitigation (this overlaps with the Holistic Control Strategies focus area) c. Determine relative source contributions – what percentage of exposure is attributed to water? (Highest Priority within this focus area) Note: It was mentioned that water sources were a significant source of DBPs and that it be helpful to start with this class of CEC. 3. Given the new state of the science, develop approaches to incorporate the new science into risk assessment a. Review current methods and identify problems 4. Develop action triggers (How much is too much)? a. Occurrence and relative dose, relative source contribution – develop a process for deciding what to move forward with b. Model consumption and dose c. Clarify what we can tolerate – is this a biological question or a relative risk question? (for example, what level of risk can we tolerate, since there never will be true zero detection) d. Consider relative source contributions e. Bioanalysis of water for estrogenic or other types of endocrine disrupting activity, unknowns analysis. f. Sensitive sub-populations adequately addressed (life stage dependent) – use as the benchmark to determine threshold 5. Risk Characterization – how do we determine what presents a risk? a. Provide a process (Is there a level at which a CEC will no longer become a risk?) 6. Identify how we get alerted to new CECs. a. CCL list and beyond b. Synthesis of information from CCL, Toxic Substances Control Act reform, pharmacokinetics, Tox21 7. Look at mixtures using front-end assays (front parts of Tox21, high through-put assays) 8. Use bioassays in a tiered approach to compare concentrations to threshold risk and determine estrogenic equivalence (relative risk). a. Bioassays may help to prioritize what chemicals (e.g. CECs, metabolites, biologically-active natural chemicals) to focus on. b. Use bioassays based on common modes of action to determine if there is a basis for concern i. Chronic vs. Acute risk 9. End goal: utilities need to understand the information and make decisions, so technology transfer is needed. a. Define the base line b. Synthesize current information Proposed Framework The group proposed the following framework for assessing risk of new CECs. The group noted synergies between the proposed framework and the current CCL3 process, which is depicted below. Abbreviations ADI CALUX CCL CDC CEC CWN DBP EC EDC EPA GWRC IWRM MOA MWWE NHANES NIEHS POE POU PPCP QSPR SAR TZW USGS UV WaterRF WERF WQRA WSAA WRF YES Acceptable daily intake Chemical-Activated Luciferase Gene Expression Contaminant Candidate List Centers for Disease Control Chemicals of emerging concern Canadian Water Network Disinfection by-product Emerging contaminant Endocrine disrupting compound Environmental Protection Agency Global Water Research Coalition Integrated Water Resources Management Mode of action Municipal wastewater effluent National Health and Nutrition Examination Survey National Institute of Environmental Health Sciences Point of entry Point of use Pharmaceuticals and personal care products Qualitative structure – property relationship Structure – activity relationship Technologiezentrum Wasser (Water Technology Center) United States Geological Survey Ultraviolet Water Research Foundation Water Environment Research Foundation Water Quality Research Australia Water Services Association of Australia WateReuse Research Foundation Yeast estrogen screen