Cherrie Whiteley
NANOTECHNOLOGIES,
REGULATORY FRAMEWORK,
ISSUES IN CONDUCTING A RISK
ASSESSMENT
WWW.THENANOCENTRE.COM
Supporting the
commercialisation of
nanotechnologies
through appropriate
risk assessment
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
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.
WWW.THENANOCENTRE.COM
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.
WWW.THENANOCENTRE.COM
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)
WWW.THENANOCENTRE.COM
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.
WWW.THENANOCENTRE.COM
APPLICATIONS & USES
2006 D.Hawxhurst/Wilson Centre: A. Maynard’s Nature
Vol444 16 Nov 2006
WWW.THENANOCENTRE.COM
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)
WWW.THENANOCENTRE.COM
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.
WWW.THENANOCENTRE.COM
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/)
WWW.THENANOCENTRE.COM
NANOTECHNOLOGIES FUNDING
UK funding
• Commissioned Reports:
RS/RAEndg, RCEP,
EMERGNANO.
• EPSRC research 08/09 - £19m
Total UK Funding
estimate since 2007
EU Funding
• 2007-13, FP7:53.2 billion euros,
3.5b euros for Nano call
• UK expects to receive 100m
euros for nanotechnologies
related research
£122.7m
International Funding
• 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)
WWW.THENANOCENTRE.COM
NANO IN THE ENVIRONMENT
• Asbestos
?
Nanotubes
?
Nanoparticles
Edinburgh Group: Donalsdon K
WWW.THENANOCENTRE.COM
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?
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
NANO IN THE ENVIRONMENT
• Nano Silver…Colloidal silver…Silver ions
• Exposure may lead to Argyria a permanent effect where
skin turns blue.
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
NANO IN REGULATION - UK
Biocidal Products
Regulations 2001
Landfill (England and
Wales) Regulations 2002
Health & Safety at Work
Act 1974
Registration, Evaluation
Hazardous Waste
and Authorisation of
(England and Wales)
Chemicals
Regulations 2005
Water Resources Act
1991
Nano
Regulation
?
Waste Management
Licensing Regulations
1994
Clean Air Act
1993Groundwater
Regulations 1998
Pollution Prevention and
Control (England and
Wales) Regulations 2000
Medicines for Human
Use (Marketing
Authorisations etc.)
Regulations 1994
Directive 2002/96/EC on
Waste Electrical and
Electronic Equipment
Plant Protection Products
Regulations 2005
Cosmetic Products
(Safety) Regulations
2004
Environmental Protection Food Safety Act 1990
Act 1990
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.
WWW.THENANOCENTRE.COM
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.
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
RISK ASSESSMENT ISSUES
DEFRA Guidelines for Environmental Risk
Assessment and Management
WWW.THENANOCENTRE.COM
RISK ASSESSMENT AND
NANOMATERIALS
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
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)
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
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
WWW.THENANOCENTRE.COM
THANK YOU
Contact:
Cherrie Whiteley, Lancaster University, PhD Student.
c.whiteley@lancaster.ac.uk
c.whiteley@thereachcentre.com
www.thenanocentre.com
WWW.THENANOCENTRE.COM