Office of Research and Development National Exposure Research Laboratory

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

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.

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: • chemical properties • prioritization and screening • hypothesis-driven targeted research • systems understanding of complex environmental risk.

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

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

6. NRC Report —Exposure Science in the 21st Century 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 21st Century, and Science and Decisions: Advancing Risk Assessment. Report released September 7, 2012

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.

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 forassessing biologically active internal exposures from external sources.

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 forassessing biologically active internal exposures from external sources. Far field?

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 forassessing biologically active internal exposures from external sources. Near field? Far field?

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 forassessing biologically active internal exposures from external sources. Exposomic? Near field? Far field?

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 forassessing biologically active internal exposures from external sources. ECO-EXPOSOME Exposomic? Near field? Far field?

13. Drivers for Exposure Science and the Report • 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

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

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

16. The Vision • Develop a universal exposure-tracking frameworkto 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 andcharacterize exposures across multiple levels of integration (time, space, biological scales)

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

18. Classic Environment-Health Paradigm

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

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.

21. Societal • Population health • Economic security • Well-being • Sustainable -intergenerational Exposure Science • Policy/Regulatory • Risk assessment • Risk management • Accountability • Sustainable actions • Health/Environmental • Human health • Ecosystem health, function , services • Market • Life cycle impacts • Sustainable solutions • 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

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

23. Key Concept Use advanced technologies to move exposure science forward Models, databases, decision support tools

24. Demands for Exposure Science • Need information on thousands of new chemicalsentering the market each year. • Need to address health effects of low-level exposuresto 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

25. Some early actions…. • 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

26. Realizing the Vision: Recommendations • 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

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

28. Moving EPA’s Science Forward • 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)

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 21st 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)

30. Important 1st 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

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

32. Rollout to Scientific Community • Scientific Societies • ISES – October 29th 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

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

34. Acknowledgments • Jennifer Orme-Zavaleta • Peter Egeghy • Elaine Cohen-Hubal • John Wambaugh and the 2.5.3 Team • Ross Highsmith, Linda Sheldon and the NERL Prioritization Group • Kirk Smith and the NRC Committee • Just to name a few….