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: