Nanotechnologies, Regulatory Framework, Issues in conducting a risk assessment

1. Cherrie Whiteley Nanotechnologies, Regulatory Framework, Issues in conducting a risk assessment

2. Environmental and Regulatory Supporting the commercialisation of nanotechnologies through appropriate risk assessment Compliance Consumer Acceptance Physics of Failure and Reliability

3. 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

4. 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.

5. 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.

6. Scale? RS/RAEng 2004

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

8. 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.

9. Applications & Uses 2006 D.Hawxhurst/Wilson Centre: A. Maynard’s Nature Vol444 16 Nov 2006

10. 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)

11. 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.

12. 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/)

13. Nanotechnologies Funding 2009 Gov response on RCEP 2008 27th Report

14. 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)

15. Nano in the environment • Asbestos NanotubesNanoparticles ? ? Edinburgh Group: Donalsdon K

16. 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?

17. 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

18. Nano in the environment • Nano Silver…Colloidal silver…Silver ions • Exposure may lead to Argyria a permanent effect where skin turns blue.

19. 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

20. 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.

21. 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.

22. 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

23. Risk Assessment ISSUES DEFRA Guidelines for Environmental Risk Assessment and Management

24. Risk Assessment and nanomaterials

25. 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

26. 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)

27. 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

28. 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

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