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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
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
Regulatory Risk Assessment
Toxicology
Analytical CapabilityExposure
Risk Assessment
How Have We Done?
Scale of Progress
~ 100
Chemical MCLs
Scale of Progress
110 MCLs
558 chemicals in EPA’s Tox Database
(IRIS)
Scale of Progress
110 MCLs
558 compounds in IRIS
~2400 compound TSCA HPV
Scale of Progress
110 MCLs
558 compounds in IRIS
~2400 compound TSCA HPV
68,000,000 in commerce
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
Contaminants of Emerging Concern
• Pharmaceuticals
• Flame retardants
• Perfluorinated Compounds
• Personal Care Products
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
Contaminant of Emerging Concern are…Chemicals, but also…• Physical materials
—Micro plastics—Nanoparticles
• Pathogens
• Radionuclides
www.noaa.gov
www.ngdc.noaa.gov
www.bioenergyconsult.com
“Perceived Threat” is Common Concept
• Not risk, but perception of risk
Mortylefkoe.com
Toxicology
Analytical CapabilityExposure√ √
X
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!!!!
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
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
