NER: Identifying & Regulating Environmental Impacts of NanotechnologyPI: N. Swami; Co-PI: M. Gorman; Students (Degree Program): A. Wardak (Ph.D.), E. Fauss (MS), S. Deshpande (MS); University of Virginia, Charlottesville, VA 22904
RationaleRealizing market potential of nanotechnology, requires upstream identification of uncertainties: risk & opportunity
What are some of the uncertainties?
• No real-time monitoring & protection technology
• Toxic effects at cellular or tissue levels
• Classification & Nomenclature for Regulation
• Multifunctional Systems that defy easy classification
• System-level effects: Cascading, Interactive, Embedded
Project GoalsDeveloping a framework to identify the risks and impacts:
–Estimating risks from a study of potential hazards and exposure scenarios
–Including Regulatory & Knowledge Gaps in risk identification strategy
Methodology to weigh benefits against risks
Pathways to risk-based regulation vs. list-based regulation
Methodology: Scenario Analysis & Expert Elicitation
Applying TSCA (Toxic Substances Control Act) to Nano-products
What scenarios present greatest risks (likelihood & severity)What nanoparticle properties trigger greater level of riskWhat are the impacts (EHS on susceptible population, ecosystem) What are the significant regulatory gaps?
Regulatory Statutes applying to nano-products
Case Study: Carbon Nanotubes and theLow Volume Exemption (LVE)
Life Cycle Stage: ManufactureRegulatory Gap: Under TSCA, LVE limits regulation of
facilities producing <10,000 kg/yearScenario:- About 44 carbon nanotube producers (Cientifica),
and about 100 metric tons produced per year (UK Royal Society)
- “A 40 inch computer display uses one-sixth of a gram of carbon nanotube powder (roughly 10,000 nanotubes) (Mann 2004). If all 25 metric tons of carbon nanotubes going to electron emission applications (estimated above) are used for computer displays, they would enter into 150 million displays.”
Implications: Potential environmental impacts are widespread with no attention to risk. Nanomaterials change the risk assessment paradigm. Mass does not correlate risk or exposure.
Case Study: Risk Identification for Air Freshener SpraysProduct Information: 20-50 nm silver nanoparticles in polymer matrix with antibacterial properties (used as spray)High-risk scenarios: Inhalation and air release during use, water entrainment during disposalNano-property risk triggers: Easy bio-availability, anti-bacterial property, media-dependent, affect on susceptible populationsIntersection Scenarios:• Wider bio-availabilityduring air-release or water entrainment• Anti-bacterial effectsoutside product cycle•Susceptible Population(respiratory problems)
Hazard vs Exposure scenarios
Hazard
Exp
osur
e
Use Inhalation
Use Air releaseUse Skin
absorptionDisposal water entrainmentInhalation
Disposal Air
release
Disposal
Use Ingestion, water entrainment
Disposal ingestion
Disposal Skin absorption
1 3 5
1
3
5
Challenges & OpportunitiesRisk: - Including regulatory and knowledge gaps in framework - Criteria to weigh risks arising from various sourcesRegulatory:- Statutes regulate products not technologies
- Dispersed through multiple agenciesToxicology:- Standardized methods to collect toxicology data for application within risk contextRisk versus benefit analysisHazard communication to decrease exposure
Acknowledgement: NSF SES Award # 0508347
Risk Triggers
Exposure Scenarios
Nano - product Information
Expert Elicitation
Updates
Gaps
Hazard
Exposure
Real Risks Real Risks
P erceptive Risks General Public (from prior surveys)
Perceptive Risks General Public (from prior surveys)
Weighted against
Regulation
Knowledge
Scenario Analysis Phase
Expert Elicitation Phase
Multicriteria Analysis, HHM
Risk Identificati on And Mapping
Risk Triggers
Exposure Scenarios
Nano - product Information
Expert Elicitation
Updates
Gaps
Hazard
Exposure
Real Risks Real Risks Real Risks Real Risks
Perceptive Risks Gene ral Public (from prior surveys)
Perceptive Risks General Public (from prior surveys)
Perceptive Risks General Public (from prior surveys)
Perceptive Risks General Public (from prior surveys)
Weighted against
Regulation
Knowledge
Scenario Analysis Phase
Expert Elicitation Phase
Multicriteria Analysis, HHM
Risk Identification And Mapping
Expected Outcomes:
