Nanomaterial Environmental, Health, and Safety Project Committee

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Nanomaterial Environmental, Health, and Safety
Project Committee

• Karluss Thomas
• Sr. Scientific Program Manager
• September 18, 2006

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What is HESI?
HESI Health and Environmental Sciences
Institute MISSION STATEMENT To stimulate and
support scientific research and educational
programs that contribute to the identification
and resolution of health and environmental issues
of concern to the public, scientific community,
government agencies, and industry.
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What is HESI?

• Membership-based non-profit Companies pay
  annual fees to be members. (Some project funding
  also comes from government and other sources).
• Transparent All work is published and publicly
  available.
• Global scientific organization High quality
  scientific papers, meetings, and research.

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What is HESI? (contd)

• Diverse Academic advisors and government
  scientists are critical participants in projects
  and have significant input. (Tripartite approach
  is key industry academic government
  scientists).
• Responsive to a Broad Constituency New research
  program ideas solicited from industry, academic
  and government scientists internationally.
  (Annual Emerging Issues process).

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HESI Membership

• Agricultural Chemicals
• Biotechnology Products
• Chemical Industry
• Consumer Products
• Petrochemicals
• Pharmaceutical Industry
• 55 members as of October 2006
• (representing 10 countries on 3 continents)

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What HESI is NOT!!!

• Not an industry trade association no lobbying
  or advocacy purposes.
• Not designed to directly change regulatory policy
  HESI works on scientific issues.
• Not designed to address business- or
  product-related issues HESI works on scientific
  issues.
• Not a professional society individual
  scientists cannot join but are engaged in
  activities.
• Not (necessarily) a short-term fix HESI project
  objectives tend to address mid- to long-term
  scientific issues.

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2006 HESI Scientific Portfolio
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Nanotechnology

• Represents multiple technologies
• Includes applications of materials with at least
  one dimension in the 1 to 100 nm range, function
  depending on small size
• Commercial Applications
• Information technology
• Biotechnology
• Consumer products (Food Packaging)
• Pharmaceuticals
• Novel Medical Delivery Systems
• Environmental Remediation
• Nanomaterials nanoparticles, nanoparticle
  aggregates, nanoparticle/nanomaterial in matrix
  or composite

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Potential Risks from Nanomaterials

• Human Health Concerns
• Worker Health and Safety Considerations
• Environmental Exposure

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Potential Consumer Exposure Risks
Cosmetics
Textiles Fabrics
Sporting Equipment
Consumer Electronics
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Human Health Concerns

• As particle size gets smaller, there may be
  size-specific effects on activity, such as
• Will nanoparticles gain access to tissues and
  cells that normally would be bypassed by larger
  particles?
• Once nanoparticles enter tissues, how long do
  they remain there and how are they cleared?
• If nanoparticles enter cells, what effects do
  they have on cellular and tissue functions?
  Might there be different effects in different
  cells types?

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Human Health Concerns (Contd)

• What are the differences in the ADME profile of
  nanoparticles versus larger particles?
• What preclinical screening tests would be useful
  to identify potential risks (in vitro or in
  vivo)?
• Can new technologies such as omics help
  identify potential toxicities and how can these
  methodologies complement current testing
  requirements?
• Can nanoparticles gain access to the systemic
  circulation from dermal exposure? If
  nanoparticles enter skin cells, is there an
  effect on cellular functions?

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Worker Health and Safety Considerations

• Material Handling
• Appropriate Personal Protective Equipment
• Acute and Chronic Exposure Implications from
  Pulmonary and Dermal Exposure

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Potential Environmental Exposure Risks
Product Disposal
Ecosystem Impacts
Manufacturing Emissions
Surface Groundwater Contamination
Life-Cycle Impacts?
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Environmental Concerns

• Can nanoparticles be released into the
  environment following human and animal use?
• What methodologies would identify the nature, and
  quantify the extent, of nanoparticle release in
  the environment?
• What might be the environmental impact on other
  species (animals, fish, plants, microorganisms)?

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Project Committee Goals

• Review the environmental, safety and health
  aspects of nanomaterials to determine current
  knowledge-base and research needs.
• Identify unresolved scientific issues, research
  needs, and/or data gaps that would facilitate the
  development of a comprehensive risk assessment
  for nanomaterials.
• Initial focus is to develop a better
  understanding of the fundamental behavior of
  nanomaterials

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HESI Nanomaterial Safety Consortium

• Goal
• Evaluate the distribution and fate of
  nanomaterials in biological systems.
• Characterize human physiologic relevance of
  pulmonary toxicity hazards associated with
  nanomaterials.

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Fate and Distribution Objectives

• Model and method development
• Assess impact of size on translocation from
  portal of entry
• Assess whether route of exposure can impact
  assumed translocation
• Generate basic information on kinetics of
  elimination
• Attempt to generate mass-balance information on a
  model nanoparticle

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Fate and DistributionProtocol Summary

• Material - Fluorescent Polystyrene Beads
• Species - Mouse
• Sizes 20nm, 40nm, 100nm, 1000nm
• Exposure IV and Pharyngeal Aspiration
• Evaluation 1, 7, 28 days post exposure
• Tissue - liver, spleen, gut, lung, heart, kidney

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Toxicity Evaluation

• Intratracheal Instillation
• Pharyngeal Aspiration
• Direct Pulmonary Exposure

• Endpoints
• Bronchoalveolar Lavage (BAL)
• Tissue Morphology

In Vivo Techniques
In Vitro Techniques

• Cytotoxicity
• Reactive Oxygen Species

Carbon Black
Titanium Dioxide
Wistar Rat
Carbon Nanotubes
Crystalline Silica
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Consortium Participants

• 3M Corporation
• Arkema, Inc.
• BASF Corporation
• Bayer AG
• Cabot Corporation
• Degussa AG
• Duke University Medical Center
• East Carolina University
• General Electric Corporation
• LOreal Corporation

• National Institute of Environmental Health
  Sciences
• National Institute of Occupational Safety and
  Health
• The Dow Chemical Company
• The Procter Gamble Company
• US Consumer Product Safety Commission
• US Environmental Protection Agency
• US Food and Drug Administration