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?
•
•
•
•
• Resource Conservation &
Recovery Act
• Federal Insecticide,
Fungicide and Rodenticide
Act
• Food Quality Protection Act
Clean Air Act
Safe Drinking Water Act
CERCLA (Superfund)
Toxic Substances Control Act
Regulatory Risk Assessment
Toxicology
Exposure
Risk Assessment
Analytical
Capability
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
~275 ME MEGs
110 MCLs
~165 ME Soil
558 compounds in
IRIS
~2400 compound TSCA HPV
68,000,000 in commerce
>90,000,000 unique
chemical substances
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
www.ngdc.noaa.go
v
• Radionuclides
www.bioenergyconsult.com
www.noaa.gov
“Perceived Threat” is Common Concept
• Not risk, but
perception of
risk
X
Toxicology
√
Exposure
√
Analytical
Capability
Mortylefkoe.com
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
Thank you for your time.
Patrick Gwinn
pgwinn@integral-corp.com