1. Regulatory Chemical Risk Assessment From Superfund to Contaminants of Emerging Concern Where Have We Been and Where Are We Going? Patrick Gwinn November 19, 2015

2. Where Did Regulatory Health Risk Assessment Come From? Clean Air Act Safe Drinking Water Act CERCLA (Superfund) Toxic Substances Control Act Resource Conservation & Recovery Act Federal Insecticide, Fungicide and Rodenticide Act Food Quality Protection Act

3. Regulatory Risk Assessment Toxicology Analytical Capability Exposure Risk Assessment

4. How Have We Done?

5. Scale of Progress ~ 100 Chemical MCLs

6. Scale of Progress 110 MCLs 558 chemicals in EPA’s Tox Database (IRIS)

7. Scale of Progress 110 MCLs 558 compounds in IRIS ~2400 compound TSCA HPV

8. Scale of Progress 110 MCLs 558 compounds in IRIS ~2400 compound TSCA HPV 68,000,000 in commerce

9. Scale of Progress 110 MCLs 558 compounds in IRIS ~2400 compound TSCA HPV 68,000,000 in commerce >90,000,000 unique chemical substances ~275 ME MEGs ~165 ME Soil

10. Contaminants of Emerging Concern Pharmaceuticals Flame retardants Perfluorinated Compounds Personal Care Products

11. Contaminants of Emerging Concern Pathway to environment Real or perceived risk Knowledge lacking or evolving  No environmental standards  New science  New detection capabilities  New exposure pathways

12. Contaminant of Emerging Concern are… Chemicals, but also… Physical materials —Micro plastics —Nanoparticles Pathogens Radionuclides www.noaa.gov www.ngdc.noaa.go v www.bioenergywww.bioenergyconsult.co m

13. “Perceived Threat” is Common Concept Not risk, but perception of risk Mortylefkoe.com Toxicology Analytical Capability Exposure √ √ X

14. Consider…. ~ 15,000 employees in the USEPA Assume that —Each employee ONLY addresses safety of chemicals in commerce —Only 10% of the 68 million chemicals currently in commerce need assessment —All toxicity and exposure data are available —Each assessment takes 3 months to complete You would need more than 100 years to complete the work!!!!

15. Change is Needed to the Way We Assess Chemical Risk Shorter-term —Methods to prioritize chemicals —More tiered, faster assessments —Testing and data to support » Users & Manufacturers » International Long-term —Move away from chemical-by-chemical assessment toward classes/groups —Predictive tools for exposure, toxicity —Effects-based rather than chemical monitoring

16. Summary Emerging contaminants are a collective concern New approaches are needed to assess and ensure safety —Reauthorization of TSCA —Streamline regulatory process Long-term solutions rooted in new tools and assessment approaches that are still being developed

17. Thank you for your time. Patrick Gwinn pgwinn@integral-corp.com