CherrieWhiteley Nano by Uk4X1i68

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									Cherrie Whiteley

NANOTECHNOLOGIES,
REGULATORY FRAMEWORK,
ISSUES IN CONDUCTING A RISK
ASSESSMENT


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   Supporting the
commercialisation of
 nanotechnologies
through appropriate
  risk assessment




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                     AGENDA
•   What is Nano?
•   Why is Nano different?
•   Application & Use
•   Market size and penetration
•   Government funding
•   Nano in the Environment
•   Policy and Regulation
•   Risk Assessment
•   Conclusion

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   NANOTECHNOLOGIES DEFINITIONS

Royal Society & Royal Academy of Engineers 2004

Nanoscience is the study of phenomena and manipulation of materials at
atomic, molecular and macromolecular scales, where properties differ
significantly from those at a larger scale.

Nanotechnologies are the design, characterization, production and application
of structures, devices and systems by controlling shape and size at nanometre
scale.




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                FURTHER DEFINITIONS
The EU Scientific Committee on Emerging and Newly Identified Health Risks
(SCENIHR) has, provided the following working definitions:

   Nanoscale: a feature characterised by dimensions of the order of 100 nm
   or less.

   Nanostructure: Any structure that is composed of discrete functional parts,
   either internally or at the surface, many of which have one or more
   dimensions of the order of 100 nm or less.

   Nanomaterial: Any form of a material that is composed of discrete
   functional parts, many of which have one or more dimensions of the order
   of 100 nm or less.


                          taken from Doc. CA/59/2008 rev. 1, Working definitions, SCENIHR.




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Scale?




         RS/RAEng 2004
            PROPERTIES OF NANO

•   Greatly increased surface area per unit mass
•   Changes chemical reactivity
•   Changes in surface charge
•   Modified electronic characteristics
                                   (RCEP 2008)




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NANO GOLD




      Lycurgus Cup (4th century
      AD), 165mm tall, with
      decorations in very intense red
      color achieved by gold and
      silver nanoparticles contained
      in the glassy phase.

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               APPLICATIONS & USES




2006 D.Hawxhurst/Wilson Centre: A. Maynard’s Nature
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Vol444 16 Nov 2006
            ENVIRONMENTAL USES
• Groundwater Remediation
  – Nanoscale Zero-valent iron injected in aquifer material, applied
    in sites in USA. Oxidation-reduction reactions degrade certain
    contaminants e.g.chlorinated ethylene's (TCE).
• Sensors
  – sensors that rely on nanotechnology are being developed to
    monitor ecological change.
• Nanocoatings
  – prevent soiling of windows and other surfaces reduce the need
    for detergents and hence the potential environmental damage
    caused by detergent use.                          (RCEP 2008)




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                              EXTENT OF USE

• Over 1000 products that can be readily purchased have
  been identified, covering 21 countries internationally.
  http://www.nanotechproject.org/inventories/consumer/browse/products



• Most products in this inventory satisfy three criteria:
   – They can be readily purchased by consumers, and
   – They are identified as nano-based by the manufacturer OR
     another source, and
   – The nano-based claims for the product appear reasonable.

• Within UK - VRS (Voluntary Reporting System).
   – DEFRA To date 13 data submissions: 11 from industry and 2
     from academia.


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              COMMERCIAL MARKET
• In 2007, $60 billion worth of nano-enabled products
  were sold.

• Nanotechnology will also produce employment
  opportunities, with an anticipated 7 million jobs
  generated globally by nanotechnology in the next
  decade

• By 2014, the Lux Research group predicts that $2.6
  trillion in manufactured goods will incorporate
  nanotechnology — about 15% of total global output.
      (http://www.nanotechproject.org/topics/nano101/introduction_to_nanotechnology/)



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              NANOTECHNOLOGIES FUNDING

                                                      • Commissioned Reports:
                                         UK funding     RS/RAEndg, RCEP,
                                                        EMERGNANO.
                                                      • EPSRC research 08/09 - £19m




                        EU Funding                                                      Total UK Funding
                                                                                        estimate since 2007
• 2007-13, FP7:53.2 billion euros,
  3.5b euros for Nano call                                                              £122.7m
• UK expects to receive 100m
  euros for nanotechnologies
                                               International Funding
  related research

                    • US: National Nanotechnology Initiative (NNI)
                      2007=$1.4b;2008 = $1.5b; 2009 = $1.6b;
                    • OECD: WPNM £30-40m 14 nanomaterials.
                    • UK £3.7m cerium oxide & zinc oxide.




2009 Gov response on RCEP 2008 27th Report                                            WWW.THENANOCENTRE.COM
            NANO IN THE ENVIRONMENT
Possible Environmental significance of Nano properties:

Surface chemistry. Surface activity may give rise to pronounced bioactivity.

Surface charge determines the chemistry and interactions of a material,
particularly how it forms solutions or Suspensions. These interactions
determine its mobility in the environment and its bioavailability.

Hydrophobicity/hydrophilicity How hydrophilic/hydrophobic a material is will
have a significant effect on its mobility in the environment and its bioavailability.

State of aggregation effect on the properties of a material, in particular on how
it is transported through the environment, its bioavailability and toxicity.
                                                                    (RCEP 2008)



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        NANO IN THE ENVIRONMENT
             ?               ?
• Asbestos       Nanotubes         Nanoparticles




                                 Edinburgh Group: Donalsdon K

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         NANO IN THE ENVIRONMENT
Nano Silver:

• Increase in Production and usage:
   – Medical catheters, water purification, clothing/textiles, paints,
     deodrants, colloidal silver.
• Taking advantage of antibacterial and fungicidal
  properties – surface area.

• Where does Silver go in the environment?
• What is its form?


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         NANO IN THE ENVIRONMENT

• Potential for nanosilver leaking into waste water
   – impregnated socks lose nearly 100% of their silver content within
     four washings. (Benn et al. 2008).
   – existing levels
• Potentially disrupting bacteria used in waste-water
  treatment facilities, or endangering aquatic organisms in
  lakes and streams.
• Some studies show capability to enter cells and cause
  cellular damage


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        NANO IN THE ENVIRONMENT
• Nano Silver…Colloidal silver…Silver ions

• Exposure may lead to Argyria a permanent effect where
  skin turns blue.




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                      UK NANO POLICY
• The UK Nanotechnologies Strategy was published on
  18th March 2010
   – Set out to ensure that everyone in the UK can safely benefit from the societal
     and economic opportunities that these technologies offer, whilst addressing the
     challenges that they might present.

• Nanotechnology Research Strategy Group (NRSG)
  formally (Nanotechnology Research Coordination Group)
   – Task Force 1: Metrology, Characterisation, Standardisation and Reference
     Materials
   – Task Force 2: Exposures – Sources, Pathways and Technologies
   – Task Force 3: Human Health Hazard and Risk Assessment
   – Task Force 4: Environmental Hazard and Risk Assessment
   – Task Force 5: Social and Economic Dimensions of Nanotechnologies.

• Nanotechnologies Stakeholder Forum

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                             NANO IN REGULATION - UK




                                                                Nano
                                                              Regulation
                                                                  ?




More than 60 pieces of regulation have been reviewed that affect nanomaterial
(Frater, L., Stokes, E., Lee, R. and Oriola, T. (2006). An overview of the framework of current regulation affecting the development and
marketing of nanomaterials. A report for the Department for Trade and Industry (DTI). December 2006.


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              NANO REGULATION
• UK Government believe UK and European regulations to
  be sufficiently broad and flexible to handle
  nanotechnologies in their current stage of development.

• REACH: manufacturers, importers and downstream
  users have to ensure that their nanomaterials do not
  adversely affect human health or the environment.

• 2012 review of REACH with modification expected to
  reflect future uses and risks.


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                  NANOMATERIALS IN REACH:
• REACH does not refer specifically to nanomaterials
• REACH has a 1 tonne threshold
       – potential exclusion for registration and data requirements.
• Substance identification
       – Nano characterised as new or existing
• Specific hazards require additional testing
       – End points guidance required
       – Lack of information to inform risk management




Nanomaterial in REACH Doc. CA/59/2008 rev. 1




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RISK ASSESSMENT ISSUES




                 DEFRA Guidelines for Environmental Risk
                 Assessment and Management


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RISK ASSESSMENT AND
   NANOMATERIALS




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            RISK ASSESSMENT ISSUES

Framework approaches being proposed:
• Screening Approach of 5 steps developed at workshop sponsored
   by The Pew Charitable Trusts, WWIC for Scholars applying Lifecycle
   Analysis, risk analysis and scenario analysis.
• Dupont & Environment Defence developed Nano Risk Framework
   focus on potential environmental, health and safety risks, 6 steps .
• XL Insurance Database protocol, Rice University uses protocol used
   to calculate insurance premiums for chemical industry.


Nanotechnology and the environment P.250 K Sellers 2009




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           RISK ASSESSMENT ISSUES
Emergence of information - Qualitative representation of gap between
the emergence of products containing nanomaterials in comparison to
the generation of environmental health and safety data (EHS) and their
subsequent use by regulatory agencies.




                                                                (RCEP 2008)

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         RISK ASSESSMENT ISSUES

• Lack of data and information about effect of NP properties on human
  toxicity, toxicokinetic, and environmental behaviour

• Lack of Studies on fate and behaviour in the environment


• Lack of standardized testing protocols


• No predictive models for the estimation of external and internal
  exposure and toxic effects




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                    CONCLUSION
•   Massive future potential of Nanotechnologies
•   Regulations developing - slowly
•   Need to build quality data
•   Case-by-case approach to risk assessment
•   Risk Assessment protocols to be agreed




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                    THANK YOU

Contact:
Cherrie Whiteley, Lancaster University, PhD Student.
c.whiteley@lancaster.ac.uk
c.whiteley@thereachcentre.com
www.thenanocentre.com




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