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www.lovells.comLovells LLP

Nanotechnology and Product Liability

Rod Freeman - Partner

Product Liability GroupLovells LLP

6 February 2009


The challenges of new technology


Product safety - the lessons of history


The challenges of nanotechnology

• Spectacular promises, benefits for all

• ...but at what price?

– these questions arising in a world in which consumers are increasingly intolerant to risk


Nanotechnology

Dr Marion Palmer

Senior Scientist

Lovells Science Unit


Definition

• Most widely used definition:

– 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, characterisation, production and application of structures, devices and systems by controlling shape and size at nanometre scale.


Millimetre scale (1 m = 1000 mm)ant and flea

• 5 mm

• 3mm

• 1mm

http://www.nationalinsectweek.co.uk/resources/buzz_ant_06.pdf

www.nanotec.org.uk/report/chapter2.pdf

http://commons.wikimedia.org/wiki/File:Drosophila_melanogaster_-_front_(aka).jpg


Micrometre scale (1 mm = 1000 µm)eye of a fruit fly and a red blood cell

• 400 µm • 8 µm

http://www.molbio1.princeton.edu/facility/confocal/sem/imagelist1.html

www.mta.ca/dmf/blood.htm


Nanometre scale (1 µm = 1000 nm) – viruses & DNA

• 50 – 100 nm • 2 nm

http://www.gala-instrumente.de/images/deben_CCD_DNA.jpg

www.answers.com/topic/virus


Nanostructures

• Nanoparticles


Nanostructures

• Fullerenes – e.g. carbon nanotubes and buckyballs


Nanostructures

• Quantum dots

http://www.nist.gov/public_affairs/update/quantumdots.htm

http://www.nanopicoftheday.org/2003Pics/QDRainbow.htm


Nanostructures

• Non-carbon nanotubes

• Nanowires

• Biopolymers

• Dendrimers

http://nano.med.umich.edu/projects/dendrimers.html

http://www.nist.gov/public_affairs/05nano_image_gallery.htm


Nanotechnology

What make technology at the nanoscale different from technology at the macroscale?


Volume to surface area ratio

• As objects get smaller they have a much greater surface area to volume ratio

2 cm cube has a surface area of 24 cm2 and a volume of 8 cm3 (ratio = 3:1)

10 cm cube has a surface area of 600 cm2 and a volume of 1000 cm3 (ratio = 0.6:1)


Physical properties

• At very small sizes physical properties (magnetic, electric and optical) of materials can change dramatically.

http://www.omicron.de/index2.html?/results/spin_polarized_tunneling_induced_luminescence_microcopy_sp_tilm/index.html~Omicron


Applications

• Antibacterial effect of silver

www.nanotech-now.com


Applications

• Coatings - self-cleaning windows and stainproof clothing


Applications

• Microchips

•http://ion.asu.edu/cool66_IC2/cool66_ic_thumb.htm


Applications

• Sunscreens and cosmetics


Applications

• Catalysts– Envirox™ cerium oxide

• Nanoremediation – SAMMS technology to remove

mercury

• Paper– photographic paper

• Filters– nanofibres

• Toothpaste– to remineralise teeth

• Food– packaging

• Paint – improved adhesion and anti-

fungal qualities/anti-graffiti

• Clothes – non-staining and anti-radiation

• Batteries– (Black & Decker) phosphate

nanocrystal technology

• Cleaning products


Why is there so much interest/concern about nanotechnology?

• Enormous potential

• Huge gaps in knowledge concerning the possible risks

• Difficulty in detecting and removing

• Absence of regulation


Potentials risks associated with nanotechnology

• Adverse health effects in humans from deliberate or accidental exposure

• Adverse effects on the environment from deliberate or accidental exposure

• Potentially explosive properties of nanostructures

• “Grey goo”


Risk assessment problems

• Very difficult to detect without sophisticated equipment

• Difficult to predict how particles will behave in the environment (dispersed/clumped)

• Small size may result in particles passing into the body more easily (inhalation, ingestion, absorption)

• May be more reactive due to surface area to volume ratio

• Potential to adsorb toxic chemicals

• Persistence - Longevity of particles in the environment and body are unknown


Toxicological difficulties

• All structures are likely to have a unique toxicological profile

• Standardised terminology agreed recently

• Particle size may be less important than the surface characteristics of the material

• Standard dose-response tests may not be appropriate


Carbon nanotubes

http://www.nano-lab.com/nanotube-image.html


Carbon Nanotubes

• Commercially produced by companies such as Thomas Swan

• Desirable product

http://www.tennis.com/yourgame/gear/racquets/babolat/babolat.aspx?id=56932


Potential applications of carbon nanotubesMaterials & Chemistry

- Ceramic and metallic CNT composites

- Polymer CNT composites (heat conducting polymers)

- Coatings (e.g. conductive surfaces)

- Membranes and catalysis- Tips of Scanning Probe Microscopes

(SPM)

Medicine & Life Science

- Medical diagnosis (e.g. Lab on a Chip (LOC))

- Medical applications (e.g. drug delivery)

- Chemical sensors

- Filters for water and food treatment

Electronics & ICT- Lighting elements, CNT based field

emission displays- Microelectronic: Single electron transistor- Molecular computing and data storage- Ultra-sensitive electromechanical sensors- Micro-Electro-Mechanical Systems

(MEMS)

Energy- Hydrogen storage, energy storage (super

capacitors)- Solar cells- Fuel cells- Superconductive materials


Carbon nanotubes

• Have raised concerns due to a superficial likeness to asbestos fibres and extreme durability

• Potential exposures during manufacturing, processing, product use and disposal

• Have been researched more than most manufactured nanostructures


CNT Research

• Results have been variable dependent on dose, testing model, purity and type of nanostructure

• Research results to date:

– Some coated CNTs appear to move freely throughout the body (mice) whereas others are rapidly excreted

– Installation experiments have shown inflammatory, fibrotic and immune changes

– Inhalation experiments have shown small changes in the lung

– Effects on the immune system

– Effects on cell growth and death

– Modification of tube coating by aquatic organisms


IOM HARN Report

• Funded by Defra

• Objective – "to undertake a scoping study to review the existing literature on industrial fibres and HARN to determine whether high aspect ratio nanoparticles (HARN) should raise the same concerns as do asbestos fibres"

• "This review has identified many similarities between HARN and asbestos with regard to their physico-chemical properties and toxicological effects and has concluded that there is sufficient evidence to suggest that HARN which have the same characteristics (diameter, length and biopersitence) as pathogenic fibres are likely to have similar pathology.This review has also highlighted the lack of data in key areas of toxicology, exposure and assessment."


Regulation

• New generic nanotechnology regulations would be difficult to devise.

• More likely that current regulations/legislation will be adapted to take account of developments at the nanoscale.

• Review by the European Commission* on the regulatory aspects of nanotechnology : chemicals (REACH), worker protection (e.g. Directive 89/391/EEC), products (e.g. General Product Safety Directive), environmental protection (e.g. Directive 2006/12/EC on waste)

• "Current legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials ...."

*Regulatory Aspects of Nanomaterials – Communication from the European Commission 2008


REACH

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals

• "REACH is based on the principle that manufacturers, importers and downstream users have to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment."

• Places an obligation on importers/manufacturers to produce a registration dossier for any substance that is imported/manufactured in a quantity greater than 1 tonne (>10 tonnes – chemical safety report)

• Commission report states "There are no provisions in REACH referring explicitly to nanomaterials. However, nanomaterials are covered by the “substance” definition in REACH."


REACH and nanomaterials

• Registration document will need to be updated if a nanoversion of a material is introduced– however novel nanomaterials may not reach the weight threshold

for notification

• Current testing guidelines may need to be modified – in the interim testing should be carried out according to existing guidelines

• Substances of high concern require special authorisation – effects of most nanomaterials are unknown


October 2008• Amendment (Commission Regulation (EC) No 987/2008)

concerning the removal of carbon and graphite from lists of exempt materials:

• "The review carried out by the Commission pursuant to Article 138(4) has revealed that three substances listed in Annex IV should be removed from that Annex, as insufficient information is known about these substances for them to be considered as causing minimum risk because of their intrinsic properties ... This is also the case with carbon and graphite, in particular due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex."


Nanotechnology and product liability

1. New technology and the concept of "defect"

2. Development risks

• what is "discoverable"?

• emerging knowledge and the benefit of hindsight


Nanotechnology and product liability

• Regulatory intervention and regulatory compliance

• Implications of REACH-style regulation

• Relative responsibilities • innovators• other suppliers• regulators

• Duties to research/test/investigate/inquire

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