[PPT] - A Framework for Risk-Informed Assessments of Nanomaterials Jo Anne PowerPoint Presentation

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A Framework for Risk-Informed Assessments of Nanomaterials

Jo Anne Shatkin, Ph.D. The Cadmus Group, Inc. jshatkin@cadmusgroup.com International Congress of Nanotechnology November 2, 2005 San Francisco, California

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Overview

Why be concerned about nanoscale

material impacts?

The importance of addressing risks now
Risk assessment: Its not just hazards
Assessing risks of nanoscale materials
Adaptive decision making framework

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Why be concerned about nanomaterial impacts?

Novel properties
History dictates action
Technology advancing quickly
Paucity of information
Potential for wide dispersion in the environment amidst

uncertainty

No standards - yet!

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Source: K. Thompson, 2004.

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Commercial Development of Nanotechnology Benefits from Risk Assessment

Risk assessment:

Will be the basis for regulatory decision making
Allows decision making under uncertainty
Keeps pace with technology
Prioritizes research directions
Identifies areas for product innovation
Reduces potential for unforeseen impacts

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Assessing risks of nanoscale materials

Identify and characterize hazards
Assess exposure potential
Evaluate toxicity
Characterize risk
Communicate about risks

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Differentiating hazards from risks

All materials are toxic at some concentration
There is no risk if there is no exposure
Risk = hazard * exposure probability

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Adaptive decision framework

A screening tool to identify and prioritize key

health and process issues

Dynamic approach applies broadly to array of

hazards

Identifies key uncertainties
Revisits early decisions with new information
Applies to health and safety concerns

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Adaptive decision framework

Steps sequentially across processes through

product or lifecycle

Evaluates risk at each step
Focuses on exposure potential
Transparent decision framework allows comparison
f different products and processes amidst

uncertainty

Proactive approach for evaluating safety of novel

materials

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RAW MATERIALS Process USE PRODUCT Packaging ID AND CHARACTERIZE HAZARDS EVALUATE TOXICITY ASSESS EXPOSURE CHARACTERIZE RISK MITIGATION MEASURES

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Example SWCNT Fabrication

RAW MATERIALS Process USE PRODUCT Packaging ID and CHARACTERIZE HAZARDS

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Nanoparticle Characterization Across Studies

1.E+00 1.E+01 1.E+02 1.E+03 1.E+04 1.E+05 1.E+06 1.E+07 1.E+08 1.E+09 NP/cm3 [CNT] ug/m3 SA(m2/g) Particle diameter (nm) Measurement/ Estimate

Value Silica Shvedova, 2005 Ultrafine Carbon black Shvedova, 2005 CNT by Intratracheal Installation Shvedova, 2005 CNT facility Maynard, 2004 Ambient Air Warheit, 2004 Welding fumes EC 2005 (Möhlmann, 2004)

= estimated

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Example SWCNT Fabrication

RAW MATERIALS Process USE PRODUCT Packaging ID HAZARDS ASSESS EXPOSURE

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Exposure Measures of SWCNT (Particles/m3)

1.E+00 1.E+01 1.E+02 1.E+03 1.E+04 1.E+05 1.E+06 1.E+07 1.E+08 1.E+09 1.E+10 1.E+11

Chamber Entry Removing SWCNT Vacuuming CleanUp Process

# Particles

Laser Ablation 2 Laser Ablation 1 HiPCO 1 HiPCO 2 Source: Maynard et al. 2004

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Nanoparticle Characterization Across Studies

1.E+00 1.E+01 1.E+02 1.E+03 1.E+04 1.E+05 1.E+06 1.E+07 1.E+08 1.E+09 NP/cm3 [CNT] ug/m3 SA(m2/g) Particle diameter (nm) Measurement/ Estimate

Value Silica Shvedova, 2005 Ultrafine Carbon black Shvedova, 2005 CNT by Intratracheal Installation Shvedova, 2005 CNT facility Maynard, 2004 Ambient Air Warheit, 2004 Welding fumes EC 2005 (Möhlmann, 2004)

= estimated

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Example SWCNT Fabrication

RAW MATERIALS Process USE PRODUCT Packaging ID HAZARDS ASSESS EXPOSURE EVALUATE TOXICITY

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Nanoparticle Characterization Across Studies

1.E+00 1.E+01 1.E+02 1.E+03 1.E+04 1.E+05 1.E+06 1.E+07 1.E+08 1.E+09 NP/cm3 [CNT] ug/m3 SA(m2/g) Particle diameter (nm) Measurement/ Estimate

Value Silica Shvedova, 2005 Ultrafine Carbon black Shvedova, 2005 CNT by Intratracheal Installation Shvedova, 2005 CNT facility Maynard, 2004 Ambient Air Warheit, 2004 Welding fumes EC 2005 (Möhlmann, 2004)

= estimated

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Example SWCNT Fabrication

RAW MATERIALS Process USE PRODUCT Packaging ID HAZARDS ASSESS EXPOSURE EVALUATE TOXICITY CHARACTERIZE RISK

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Example: SWCNT

Single Walled Carbon Nanotubes; packaging Hazard ID: particle diameter, surface area, particle number, concentration. Exposure Assessment: post production handling personal air sample concentrations ranged from 0.001 -0.052 mg/m3 (Maynard et al., 2004) Toxicity Evaluation: inflammatory responses in lung following intratracheal administration at doses approaching OSHA standard for graphite (5 mg/m3) (Shvedova et al., 2005), but vastly different particle numbers Risk Characterization: toxic responses possible, exposures appear to be orders of magnitude lower; much uncertainty over exposure and toxicity in realm of interest.

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Source: K. Thompson, 2004.