Office of Research and Development National Exposure Research Laboratory U.S. Environmental Protection Agency Research Triangle Park, NC July 24, 2012 Chemical Safety for Sustainability: Vision and Direction from NRC’s Exposure Science in the 21 st Century Daniel A. Vallero, PhD

Office of Research and Development 2 Chemical Safety for Sustainability Provide Scientific Knowledge, Tools & Models for Integrated Evaluation Strategies Develop the scientific knowledge, tools, and models to improve chemical information used in assessments and to make decisions about their use. Provide critical information for assessments and decision making on chemical exposure and impacts to humans and wildlife at the individual and population levels.

Office of Research and Development 3 Chemical Safety for Sustainability Provide Scientific Knowledge, Tools & Models for Integrated Evaluation Strategies Develop the scientific knowledge, tools, and models to improve chemical information used in assessments and to make decisions about their use. Provide critical information for assessments and decision making on chemical exposure and impacts to humans and wildlife at the individual and population levels. Multiple levels include: 1.chemical properties 2.prioritization and screening 3.hypothesis-driven targeted research 4.systems understanding of complex environmental risk.

Office of Research and Development 4 Chemical Safety for Sustainability Provide Scientific Knowledge, Tools & Models for Integrated Evaluation Strategies Develop the scientific knowledge, tools, and models to improve chemical information used in assessments and to make decisions about their use. Provide critical information for assessments and decision making on chemical exposure and impacts to humans and wildlife at the individual and population levels. Multiple levels include: chemical properties prioritization and screening hypothesis-driven targeted research systems understanding of complex environmental risk. Improve Assessment and Inform Management for Chemical Safety Faster, more efficient, more certain, and sustainable chemical assessments and management decisions. Support next generation of risk assessment and management approaches to help screen and prioritize chemicals for their safety and make major regulatory decisions to protect human health and wildlife. Lead to better and more efficient assessments Provide risk management options that better target where risks throughout a chemical’s life cycle

Office of Research and Development 5 Chemical Safety for Sustainability Provide Scientific Knowledge, Tools & Models for Integrated Evaluation Strategies Develop the scientific knowledge, tools, and models to improve chemical information used in assessments and to make decisions about their use. Provide critical information for assessments and decision making on chemical exposure and impacts to humans and wildlife at the individual and population levels. Multiple levels include: chemical properties prioritization and screening hypothesis-driven targeted research systems understanding of complex environmental risk. Improve Assessment and Inform Management for Chemical Safety Faster, more efficient, more certain, and sustainable chemical assessments and management decisions. Support next generation of risk assessment and management approaches to help screen and prioritize chemicals for their safety and make major regulatory decisions to protect human health and wildlife. Lead to better and more efficient assessments Provide risk management options that better target where risks throughout a chemical’s life cycle Target High Priority Research Needs for Immediate and Focused Attention Address the highest priority needs of EPA’s program and regional offices, which are responsible for developing regulations and ensuring they are implemented, respectively. Fill critical data gaps and identify high priority needs of chemical management programs using the products of the other two research areas

Office of Research and Development 6 Commissioned by ORD in 2010 – additional support from NIEHS Goals Provide a transformation for exposure science Provide a catalyst to the science Charge to the Committee Develop unifying conceptual framework for advancement of human and ecological exposure science Develop a long-range vision for exposure science and strategy for implementing the vision over the next 20 years Potential companion to NRC reports Toxicity Testing in the 21 st Century, and Science and Decisions: Advancing Risk Assessment. Report released September 7, 2012 NRC Report — Exposure Science in the 21 st Century

Office of Research and Development 7 Exposure Science Box 1-1 Definition and Scope of Exposure Science Exposure science is defined by this committee as the collection and analysis of quantitative and qualitative information needed to understand the nature of contact between receptors (such as people or ecosystems) and physical, chemical, or biologic stressors. Exposure science strives to create a narrative that captures the spatial and temporal dimensions of exposure events with respect to acute and long-term effects on human populations and ecosystems.

Office of Research and Development 8 Exposure Science Box 1-1 Definition and Scope of Exposure Science Exposure science is defined by this committee as the collection and analysis of quantitative and qualitative information needed to understand the nature of contact between receptors (such as people or ecosystems) and physical, chemical, or biologic stressors. Exposure science strives to create a narrative that captures the spatial and temporal dimensions of exposure events with respect to acute and long-term effects on human populations and ecosystems. …. A central theme of this report is the interplay between the external and internal environments and the opportunity for exposure science to exploit novel technologies for assessing biologically active internal exposures from external sources.

Office of Research and Development 9 Exposure Science Box 1-1 Definition and Scope of Exposure Science Exposure science is defined by this committee as the collection and analysis of quantitative and qualitative information needed to understand the nature of contact between receptors (such as people or ecosystems) and physical, chemical, or biologic stressors. Exposure science strives to create a narrative that captures the spatial and temporal dimensions of exposure events with respect to acute and long-term effects on human populations and ecosystems. …. A central theme of this report is the interplay between the external and internal environments and the opportunity for exposure science to exploit novel technologies for assessing biologically active internal exposures from external sources. Far field?

Office of Research and Development 10 Exposure Science Box 1-1 Definition and Scope of Exposure Science Exposure science is defined by this committee as the collection and analysis of quantitative and qualitative information needed to understand the nature of contact between receptors (such as people or ecosystems) and physical, chemical, or biologic stressors. Exposure science strives to create a narrative that captures the spatial and temporal dimensions of exposure events with respect to acute and long-term effects on human populations and ecosystems. …. A central theme of this report is the interplay between the external and internal environments and the opportunity for exposure science to exploit novel technologies for assessing biologically active internal exposures from external sources. Far field? Near field?

Office of Research and Development 11 Exposure Science Box 1-1 Definition and Scope of Exposure Science Exposure science is defined by this committee as the collection and analysis of quantitative and qualitative information needed to understand the nature of contact between receptors (such as people or ecosystems) and physical, chemical, or biologic stressors. Exposure science strives to create a narrative that captures the spatial and temporal dimensions of exposure events with respect to acute and long-term effects on human populations and ecosystems. …. A central theme of this report is the interplay between the external and internal environments and the opportunity for exposure science to exploit novel technologies for assessing biologically active internal exposures from external sources. Far field? Near field? Exposomic?

Office of Research and Development 12 Exposure Science Box 1-1 Definition and Scope of Exposure Science Exposure science is defined by this committee as the collection and analysis of quantitative and qualitative information needed to understand the nature of contact between receptors (such as people or ecosystems) and physical, chemical, or biologic stressors. Exposure science strives to create a narrative that captures the spatial and temporal dimensions of exposure events with respect to acute and long-term effects on human populations and ecosystems. …. A central theme of this report is the interplay between the external and internal environments and the opportunity for exposure science to exploit novel technologies for assessing biologically active internal exposures from external sources. Far field? Near field? Exposomic? ECO-EXPOSOME

Office of Research and Development 13 Complex societal problems and growing demand for information on environmental problems Climate change, Security threats, Urbanization, Depletion of natural resources, Increases in childhood illness Advances in measurements and computational techniques afford opportunities to study complex systems, and rapidly identify, communicate, and mitigate changes and outcomes Drivers for Exposure Science and the Report

Office of Research and Development 14 Transform exposure science in the same way that the 2007 NAS report “Toxicity Testing in the 21 st Century” changed toxicology Develop critical partnerships for our work Develop a critical mass to solve key environmental problems NRC Report – An Opportunity

Office of Research and Development 15 Calls for EPA and other federal agencies to create a broad collaborative effort to expand and modernize data collection and the study of exposure science to keep up with advances in other fields

Office of Research and Development 16 Develop a universal exposure-tracking framework to predict biologically relevant human and ecologic exposures, and generate information for making the best (most sustainable) decisions on human and ecosystem health protection. Focus on prevention and mitigation of adverse exposures Apply systems science to understand and characterize exposures across multiple levels of integration (time, space, biological scales) The Vision

Office of Research and Development 17 The Report Addresses intensity and duration of contact of humans or other organisms with agents (chemical, physical, or biologic stressors) and their fate in living systems. Instrumental in helping to: Forecast, prevent, and mitigate exposures Identify populations that have high exposures Assess and manage human health and ecosystem risks Protect vulnerable and susceptible populations

Office of Research and Development 18 Classic Environment-Health Paradigm

Office of Research and Development 19 Biological Organization Perspective Exposure science 1.Extends from point of contact between agent and receptor, inward into the organism and outward to the general environment. 2.Addresses chemical, physical, and biological stressors and associated behavioral and societal factors that affect human and ecological health 3.Central theme is the interplay between internal and external exposure and the use of novel technologies to assess biologically relevant exposures

Office of Research and Development 20 The Eco-Exposome Defined as the extension of exposure science from the point of contact between stressor and receptor inward into the organism and outward to the general environment, including the ecosphere.  Possibly a means to keep a macro and collective view to complement the move to individualized exposure (i.e. the exposome)…. Premised on scientific developments of the last decade.

Office of Research and Development 21 Societal Population health Economic security Well-being Sustainable -intergenerational Health/Environmental Human health Ecosystem health, function, services Market Life cycle impacts Sustainable solutions Policy/Regulatory Risk assessment Risk management Accountability Sustainable actions Exposure Science Demands for exposure science Plays a key role in public health protection, environmental regulation, urban and ecosystem planning, and disaster management Sustainability Context: Environmental, Economic (market), Societal

Office of Research and Development 22 Conceptual Systems Framework Core elements of exposure science — Many parts are available or are being developed. How do we put it all together? Actions or Events Disasters Climate change Market demands Population growth Policy decisions 1 Health Function Service Societal Demands Dynamic System *Adaptation from NRC Report – in red

Office of Research and Development 23 Key Concept Models, databases, decision support tools Use advanced technologies to move exposure science forward

Office of Research and Development 24 Demands for Exposure Science Need information on thousands of new chemicals entering the market each year. Need to address health effects of low-level exposures to chemical, biologic, and physical stressors over years or decades. There is need for more rapid response of exposure science to assist in the aftermath of natural and human-caused disasters Market demands require identification and control of exposures resulting from manufacture, distribution, and sale of products. Societal demands—need to complement physical sciences with social sciences: inherency + use

Office of Research and Development 25 Priorities set on those critical problems – including research to address critical knowledge gaps (e.g. CSS…) Develop strategies to expand exposure information rapidly to improve our understanding of where, when, and why exposures occur Develop advanced exposure infrastructure to forecast, prevent, and mitigate potential impacts and unintended consequences Non-targeted environmental monitoring and surveillance Sensor networks, advanced biomonitoring, activity tracking Data storage and distribution systems Predictive modeling systems and indicators to anticipate harmful exposures Some early actions….

Office of Research and Development 26 Pragmatic approach Develop strategic partnerships for data gathering to address immediate challenges Draw from scientific innovations outside traditional exposure science Leverage active initiatives and planned infrastructure –e.g. CDC National Environmental Public Health Tracking, National Ecological Observatory Network (NEON), Satellite data- earth observation systems Customize solutions to problems Engage stakeholders – including other agencies, regulators, and communities Realizing the Vision: Recommendations

Office of Research and Development 27 Initial Impressions Report reinforces view of exposure science in integrating research and directions we are taking Reinforces exposure science as transdisciplinary and that the science has matured to reduce reliance on assumptions Reinforces role of exposure science in a sustainability framework Provides a foundation on which to build Integration of human health and ecological sciences Innovation in exposure research (e.g., Apps and Sensors, GIS- Based Tools, Biomarkers, Models & Informatics) Synthesizing data into usable information rapidly

Office of Research and Development 28 Extend data infrastructure (to describe our world, including built environments, stressors in the world, receptors in the world) — coordinate with other Agencies and partners on platforms, standards. Expand data landscape - advance development and application of methods for efficient monitoring - partner on surveillance Advance models by strategically collecting data required to build, evaluate, and apply models Developing advanced analytical systems that rapidly turn data into information — must capture dynamic aspects of the environment, stressors and receptors. Increasing emphasis on understanding linked human-ecological systems (complex systems) Moving EPA’s Science Forward

Office of Research and Development 29 NRC Report Rollout — Maximize Impact Overall Goals Increase understanding of exposure science and it utility among stakeholders Work with Stakeholders and Partners to develop EPA strategy and national implementation plan to transform exposure into a 21 st century science Increase accessibility and use of products Increase internal and external engagement in exposure science research Better use exposure to provide context for ORD research Patterned after efforts on other NRC reports (i.e., Tox Testing, Science and Decisions, the Green Book)

Office of Research and Development 30 Important 1 st Step — Analysis of Report Invited Workshop – Dec 3 Goal –review of the report: Shared understanding of the report Is it an innovative framework for exposure science? What are the game changers? Are there other game changers we should be considering? How do we move forward to implement the game changers? Potential Invitees – big thinkers from: EPA, Federal partners Selected committee members

Office of Research and Development 31 Rollout within EPA NERL – All- hands meeting – October 17 th Discussion at Division level ORD – Webinar November 26 Executive council briefing EPA – Briefing to Program Offices – week of November 13 th Briefing to EPA Science and Technology Policy Council (STPC); November 14th follow up with EPA strategy Briefing to Risk Assessment forum; November 14 th Follow up with Risk Assessment Forum colloquium Regional Briefings

Office of Research and Development 32 Rollout to Scientific Community Scientific Societies ISES – October 29 th to November 3 Plenary session Symposium on current research directed at innovative goals SETAC- November 11 to15 SRA – Dec 9-12 SOT – March 10 to 14 Other Societies – developing materials for distribution Publish on joint research efforts Response to EHP Commentary – joint with NIEHS Response to ES&T article EPA and NIEHS coauthored paper Publish articles on specific topic areas in report – solicit from community

Office of Research and Development 33 Rollout to Partners and Stakeholders Develop MOU with federal partners – NIEHS, CDC, ATSDR, USGS, NOAA, USDA, CPSC, NIOSH, OSA, DoD, DoE, and others Stakeholders and Partners – Spring 2013 Workshop to develop national implementation strategy

Office of Research and Development 34 Acknowledgments Jennifer Orme-Zavaleta Peter Egeghy Elaine Cohen-Hubal John Wambaugh and the Team Ross Highsmith, Linda Sheldon and the NERL Prioritization Group Kirk Smith and the NRC Committee Just to name a few….