Nanotechnology – Within (trade) law or beyond it?

1. Nanotechnology – Within (trade) law or beyond it? gavc@law.kuleuven.be

2. 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

3. Intro – Policy context • R&D support for nano overwhelming • ‘Legislation’ typically seen as R&D framework programmes • Funds (Commission, National Science Foundation) calling for review of regulation – Parliaments lag behind

4. 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’)

5. 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’

6. 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

7. 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

8. 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

9. 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?

10. 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

11. 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

12. 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 other’s trade interests into account • SPS: attempt to harmonise scientific procedure which leads to measures, but maverick science ok, and precautionary principle allowed

13. 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’?

14. 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

15. 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

16. 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