1. Office of Research and Development Photo image area measures 1.5” H x 7” and can be masked by a collage strip of one, two or three images. The photo image area is located 3.19” from left and 3.81” from top of page. Each image used in collage should be reduced or cropped to a maximum of 1.5” high, stroked with a 1.5 pt white frame and positioned edge-to-edge with accompanying images. April 6, 2010 Exposure Data Landscape Peter P. Egeghy National Exposure Research Laboratory

2. Office of Research and Development 1 Acknowledgements NCCT Elaine Cohen Hubal Richard Judson Shad Mosher Sumit Gangwal Doris Sloan Jamie Vail NERL Dan Vallero Linda Sheldon Carry Croghan Cecilia Tan Disclaimer This work may not necessarily reflect official Agency policy.

3. Office of Research and Development 2 Outline Context History Assessment of Current Landscape Expectations of the Future

4. Office of Research and Development 3

5. 4 Large Numbers and Volumes of Chemicals are Produced Chemical production has increased spectacularly since 1970s –Expansion of chemical portfolio –Expansion of types of products –Ubiquitous integration Formidable number of chemicals in commercial use –143,000 substances in Europe –100,000 in US Approximately 30,000 substances marketed in volumes > 1 t/y –About 3,000 HPV chemicals make up 95% of total production * Projected

6. Office of Research and Development 5 Size of Chemical Universe Makes Exposure Assessment Difficult The vast majority of chemicals in commerce: –Are unmeasured in environmental or biological media –Have unknown environmental fate and exposure potential –Have non-quantified human and ecosystem health impacts Resource and technological limits Exposure modeling –Broader indicators and surrogates –Production volume, use category, product formulation, chemical release, pathways, degradation, activities/behaviors –Need for high throughput methods

7. Office of Research and Development 6 CHEMICAL INTERMEDIATES DEGRADATES PRODUCT n PRODUCT … PRODUCT 8 PRODUCT 7 PRODUCT 6 PRODUCT 5 PRODUCT 4 PRODUCT 3 PRODUCT 2 PRODUCT 1 Consumer Use Location Frequency Timing Population Market Share Food Outdoor Air Surface Dust A C T I V I T I E S Soil Indoor Air Water Chemical Transportation Production/ Formulation (Product or Processing Aid) Workplace Exposure Environmental Release Disposal Air Water Incineration Recycling Sewage Treatment Food A C T I V I T I E S Land Human Exposure RELEASE FATE/TRANSPORTCONCENTRATIONACTIVITYEXPOSURE Exposure Framework MANUFACTURE

8. Office of Research and Development 7 1992 Inventory of Data Compilation of federally managed data systems with exposure information Conducted jointly by EPA, CDC, and ATSDR Premise: Data systems exist that could be used to conduct studies and evaluate regulatory effectiveness Identified databases: –Environmental Measurements54 –Micro-Environmental Concs 10 –Human Samples 13

9. Office of Research and Development 8 Data Sharing Pressures Have Increased Changes in information technology reenergized the decades-old call for consistency and standardized procedures for collecting, storing, and reporting exposure-related information –Public Health: epidemiology, exposure limits, risk management NIH Data Sharing Policy (2003) –Data sharing plan included in application (>$500K) –OMB Circular A-110 – Applies to EPA as well Journals being asked to require basic data as supplementary material Recently, REACH legislation has produced increased interest –Manufacturers/Importers required to consider likely exposures –Predictive tools are being developed

10. Office of Research and Development 9 Accessible Exposure Databases Aid Chemical Prioritization Accessible exposure databases facilitate: –Application of environmental informatics tools –Linkages with toxicity data (ACToR, DSSTox) –Linkages with product usage data –Large-scale, multidimensional data analysis Formal representation of key concepts and relationships –Defines exposure domain and data structure Brazma et al., 2006 Genetics 7:593-605

11. Office of Research and Development 10 EPA’s Online ACToR Database (www.epa.gov/actor)

12. Office of Research and Development 11 Overview of Exposure Data Sources Exposure Source/Release Transport/Fate Environmental Concentration Production/ Import Volumes Consumer Products Environmental Releases Product Usage Information Indoor Air Monitoring Data Human Exposure Monitoring Production/ Process Information Environmental Transformation Outdoor Air Monitoring/ Modeling Water Monitoring Data Activity Patterns Information Human Biological Monitoring EPA HPVIS EPA IUR EU ESIS EPA TRI HC NPRI DOE GHG Household Products DB Voluntary Cosmetic Reg. DB EPA Pesticide Usage Data UK Pharma- ceutical Usage USDA DB EPA HPVIS ATSDR Tox Profiles DEA NFLIS Environmental Fate Simulator ECOTOX DB EU CAESAR DOE IndoorAir EPA HEDS WHO Global Indoor Air DB EPA AirData EPA NATA UN IPCC GHG EPA HEDS FDA TDS THL Platform EPA NHAPS EPA CHAD CDC NHANES EPA HEDS German ES EPA NCOD & UCM Program UK Pharm Water

13. Office of Research and Development 12 Number of Unique Chemicals by Data Type

14. Office of Research and Development 13 Other Data Aggregators UMDNJ Environmental Bioinformatics Knowledge Base (ebKB) NLM Hazardous Substances Databank (HSDB) ATSDR HazDat/Sequoia EPA Envirofacts Data Warehouse EPA DataFinder

15. Office of Research and Development 14 In Development: ExpoCast DataBase

16. Office of Research and Development 15 Another New Initiative: CTD Exposure Data Curation Pilot Curate and integrate data in CTD Develop exposure ontology Define scope of data to be curated Test curation protocol Source: C. Mattingly

17. Office of Research and Development 16 Risk21 Exposure Science Sub-Team ILSI HESI initiative to advance risk assessment –Multi-stakeholder approach and collaboration –Particular attention to exposure assessment Facilitate integration of exposure data –Rapid prioritization –Chemical evaluation –Chemical management Key focus: Exposure Data Standards –Disseminate data –Link with toxicity data

18. Office of Research and Development 17 Conclusions Exposure surrogates exist across the source-to-dose continuum New publically accessible systems are constantly being added Several efforts are currently underway to catalog and link the varied sources of exposure data These efforts support much needed predictive models for screening chemicals based on exposure Data sharing pressures will accelerate these efforts

19. Office of Research and Development 18