Nanotechnology

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Nanotechnology Within (trade) law or beyond it?

• gavc_at_law.kuleuven.be

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Overview of presentation

• Intro Policy context
• Why should we care about the law
• What does the law look like de lege lata
• What should the law look like de lege ferenda

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Intro Policy context

• RD support for nano overwhelming
• Legislation typically seen as RD framework
  programmes
• Funds (Commission, National Science Foundation)
  calling for review of regulation Parliaments
  lag behind

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Why should we care about the law

• Altruistically environment, human health
• Selfishly need for stable research and
  investment environment
• Cf. biotech/GMOs
• Generally tension regulatory/trade law (incl.
  chilling effect)

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What does the law look like de lege lata

• No specific, tailor made law
• ? no law applies
• At the very least product liability law, and
  duty of care, using the benchmark of the bonus
  pater familias

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What does the law look like de lege lata ctd

• EU usual suspects
• GMO legislation Directive 2001/18 (deliberate
  release) Dir 90/219 (contained use)
• Dangerous substances/chemicals legislation -
  quid REACH?
• Liability Directive

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What does the law look like de lege lata ctd

• US usual suspects
• Toxic substances control Act
• Occupational Safety and Health Act
• Food, Drug and Cosmetics Act
• Environmental laws CAA, CWA, RCRA

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What does the law look like de lege lata ctd

• ! US and EU risk analysis procedures compared
• 4 steps, circular/mesh v linear
• ! Different professional groups for each step
• EU more prone to precaution?
• Quid re input of regulatory agencies

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What should the law look like de lege ferenda

• 3.1 Modern environmental law and the impact of
  the precautionary principle
• What
• Legal status
• Reversal of burden of proof?

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What should the law look like de lege ferenda
ctd

• 3.2 Participation principles, ia of the Aarhus
  process
• 3.3 Environmental governance generally ia
  avoiding knowledge apartheid

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What should the law look like de lege ferenda
ctd

• 3.4 Impact of international trade law
• See also above chilling effect of the World
  Trade Organisation - WTO
• Development from GATT, General Agreement on
  Tariffs and Trade, to TBT, Agreement on Technical
  Barriers to Trade, and SPS, Agreement on Sanitary
  and Phytosantitary standards

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What should the law look like de lege ferenda
ctd

• 3.4 Impact of international trade law ctd.
• Due process requirements of WTO law, including
  genuine negotiations and duty to take each
  others trade interests into account
• SPS attempt to harmonise scientific procedure
  which leads to measures, but maverick science ok,
  and precautionary principle allowed

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What should the law look like de lege ferenda
ctd

• See interim WTO GMO moratorium ruling
• Questions re precaution
• Questions re subsequent scientific evidence
• Quid re collective preferences?

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What should the law look like de lege ferenda
ctd

• 3.5 Regulatory co-operation?
• Positive v negative harmonisation creation
  of a level playing field
• In the nano field, not just a free trade driver,
  but also necessary given the military dimensions
  of some of the technology
• Early signs of (transatlantic) regulatory
  co-operation

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What should the law look like de lege ferenda
ctd

• 3.6 Room for regulatory innovation?
• Ie move away from command and control
• Front-runner legislation?
• Who is the industry see eg classic issue of
  big industry v SMEs

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Conclusion

• Converging technologies means no easy
  regulatory pigeon-holes
• Chilling effect both of lack of regulation, and
  of trade law,
• Must not be underestimated, but
• Neither must it lead to haste