Decision Contexts in a Changing Toxicology Paradigm

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Presentation transcript:

Decision Contexts in a Changing Toxicology Paradigm Gary Ginsberg Connecticut Dept of Public Health November 20, 2017 NAS Emerging Science Workshop

Decision-Makers & Confidence Needs Govt Regulator Screening/Prioritization Testing criteria TSCA/Pesticides approvals Standard Setting Emergency Responder Urgent decisions Data poor chemicals Industries Screening new chems Consumers/NGOs Water quality Consumer products Extensive ?? Minimal

Where Does Confidence Come From? Predictive In vitro -----> In vivo anchoring Low false (+), false (-) Logical/Mechanistic Covers range of vulnerability Prior success – case studies Social and Psychological Determinants Beliefs/dogma about what is required

General Context: Advancing HHRA HHRA and PH Decisions Limited By: Data gaps Data poor chemicals Incomplete assessment of endpoints Gaps in understanding mixtures and aggregate risk Gaps in mechanistic understanding How do chemicals act (AOP)? What happens at low dose? Gaps in understanding vulnerability Life stage / Lifestyle / Pre-existing conditions Where Can New Tox Paradigm Help?

General Context Which decisions can they inform? Qualitative: Hazard Characterization? Is chemical a carcinogen, mutagen, EDC, etc. Screening and prioritization Quantitative: Standard-setting? Cost-Benefit? Which methods best for HHRA vs EcoRisk?

Regulatory Decisions: TSCA Mandate to Use New Methods to: ↓ Animal use ↓ Data gaps ↑ Efficiency Strategy needed to integrate new information into existing TSCA methods (QSAR  In vivo) Evaluate data poor chemicals in inventory New chemicals review Consumer Products Toxicity of data poor ingredients Screening alternative ingredients

Decision Context: Testing Criteria Replacement of Animal Testing What is enough evidence? Example – replacement of EDC uterotrophic USEPA OPP - in vitro screens for acute package How to integrate new data into existing databases and programs eg. Can cytotoxicity replace LD50s in MSDSs?

Decisions during Emergency Response Rapid decisions about toxicity on Released chemicals/mixtures Combustion byproducts Mitigation chemicals (e.g., dispersants)

Decisions Regarding Environmental Quality Evaluation of bioactivity of complex mixtures Is “recycled water” suitable for human use? Are there exposures of concern from packaging consumer products indoor environments

Summary Many decisions need to be better informed by advanced tox methods TSCA may lead the way? Already seeing applications in Pesticides, Environmental Quality, Emergency Response Today’s Workshop Where and how can new methods be useful? What is the level of confidence needed? How is this confidence/acceptance achieved?