Nanotechnology and Product Liability

Rod Freeman - Partner

Product Liability Group

Lovells LLP

6 February 2009

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The challenges of new technology

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The challenges of new technology

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Product safety - the lessons of history

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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

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Nanotechnology

Dr Marion Palmer
Senior Scientist
Lovells Science Unit

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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.

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

http://www.nation
alinsectweek.co.u
k/resources/buzz
_ant_06.pdf

• 3mm

http://commons.wiki
media.org/wiki/File:D
rosophila_melanoga
ster_-
_front_(aka).jpg

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

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

• 8 µm
• 400 µm

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

www.mta.ca/dmf/blood.htm
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Nanometre scale (1 µm = 1000 nm) – viruses &
DNA
• 50 – 100 nm • 2 nm

www.answers.com/topic/virus
http://www.gala-instrumente.de/images/deben_CCD_DNA.jpg
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Nanostructures
• Nanoparticles

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Nanostructures
• Fullerenes – e.g. carbon nanotubes and
buckyballs

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 Nanostructures
• Quantum dots

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

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

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Nanostructures

• Non-carbon nanotubes
http://www.nist.gov/public_affairs/05nano_image_gallery.htm

• Nanowires

• Biopolymers

• Dendrimers

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

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Nanotechnology

What make technology at the

nanoscale different from
technology at the macroscale?

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Volume to surface area ratio

2 cm cube has
• As objects get a surface area
of 24 cm2 and a
smaller they have a volume of 8 cm3
(ratio = 3:1)
much greater
surface area to
volume ratio
10 cm cube has a
surface area of 600
cm2 and a volume of
1000 cm3 (ratio =
0.6:1)

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

http://www.omicron.de/index2.html?/re
sults/spin_polarized_tunneling_induce
d_luminescence_microcopy_sp_tilm/in
dex.html~Omicron
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Applications
• Antibacterial effect of silver

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Applications
• Coatings - self-cleaning windows and stainproof
clothing

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Applications
• Microchips

•http://ion.asu.edu/cool66_IC2/cool66_ic_thumb.htm
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Applications
• Sunscreens and cosmetics

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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

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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

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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”

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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

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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
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Carbon nanotubes

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

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Carbon Nanotubes

• Commercially produced by companies such as

Thomas Swan

• Desirable product

http://www.tennis.com/yo
urgame/gear/racquets/babo
lat/babolat.aspx?id=56932
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Potential applications of carbon nanotubes
Materials & Chemistry Electronics & ICT
- Ceramic and metallic CNT composites - Lighting elements, CNT based field
emission displays
- Polymer CNT composites (heat - Microelectronic: Single electron transistor
conducting polymers) - Molecular computing and data storage
- Coatings (e.g. conductive surfaces) - Ultra-sensitive electromechanical sensors
- Membranes and catalysis - Micro-Electro-Mechanical Systems
(MEMS)
- Tips of Scanning Probe Microscopes
(SPM) Energy
- Hydrogen storage, energy storage (super
Medicine & Life Science capacitors)
- Medical diagnosis (e.g. Lab on a Chip - Solar cells
(LOC)) - Fuel cells
- Superconductive materials
- Medical applications (e.g. drug delivery)
- Chemical sensors
- Filters for water and food treatment

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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

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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

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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."

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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

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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."

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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

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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."

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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

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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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