1. Nanotechnology: an integrated product policy approach Rosalind Malcolm Professor of Law School of Law University of Surrey UK

2. The problem of definition Defining nanotechnology Determining the risk Designing the regulation

3. Risk based liability ‘to stimulate awareness of the risks and encourage the joint participation of workers and management in efforts to eliminate them’ (Health and Safety Executive, UK)

4. Risk and law But……… Where risk certain then prescriptive action And The problem of self-regulation

5. Risk: prevention and precaution Known risk? Preventive principle Uncertain risk? Precautionary principle

6. The EU on the environment EC Treaty, Article 174(2) Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

7. The EU on consumer protection EC Treaty, Article 129a, 1. The Community shall contribute to the attainment of a high level of consumer protection through: ……… (b) specific action which supports and supplements the policy pursued by the Member States to protect the health, safety and economic interests of consumers and to provide adequate information to consumers.

8. What about the precautionary principle?

9. Proportionality Requires cost-benefit-analysis / risk assessment / balance free trade with environmental integration

10. A precautionary tale Case T-13/99 Pfizer Animal Health SA/NV v Council (2002)

11. Assessing risk and nanomaterials? When risk assessment is the basis for legislation how does it apply to nano products? Relevance of the precautionary principle

12. A nanotechnology law? Or Law for nanotechnology?

13. Current regulatory frameworks Health and safety law (working with nano – the workers) Operators’ licences (working with nano – the environment) Product safety regulation (using nano – the consumer) Waste management law (disposing of nano)

14. An integrated product approach The lifecycle of a nanoproduct Cradle to grave Or Cradle and grave?

15. Target points for vertical laws The laboratory The factory The shop The home / office The landfill site

16. The vertical approach Research and development Manufacture Retail Use phase Disposal phase Transport

17. Regulatory gaps Are there gaps? Is new regulation required? What are the risks? Why do we need a law(s) for nanotechnology?

18. Identifying the gaps Scientific knowledge New legislation or adapt existing legislation? New codes/guidance? New international standards? Ethics? (Remember GMOs)

19. Regulatory challenges Preserve and promote benefits Protect from harm

20. Using an integrated product policy Identify risks Consider life cycle –Cradle to grave Take horizontal approach to product regulation

21. Integrated product policy Preventive (precautionary) approach Sustainability impact assessment (Green Paper on Integrated Product Policy (COM(2001) 68 final) and Communication on integrated product policy: building on environmental life-cycle thinking (COM(2003) 302 final).

22. Integrated product policy 3 models: REACH Environmental Impact Assessment (EIA) Product safety

23. Models for IPP REACH (Regulation 1907/2006) ‘May not manufacture, place on market, use substances which adversely affect human health or the environment’

24. Models for IPP Environmental impact assessment (EC Directive 85/337) Whereas development consent for public and private projects which are likely to have significant effects on the environment should be granted only after prior assessment of the likely significant environmental effects of these projects has been carried out

25. Models for IPP Product safety (General Product Safety EC Directive 2001/95) Risk assessment basis for product legislation

26. Reflective approach IPP is a procedure Lack of substantive challenge But … Procedures are reflective, self-educational

27. IPP for nanotechnology? Nanoproducts? Nanoprocesses? EIA for nanoproducts?

28. Conclusions A horizontal approach to the assessment of the impacts of nanoproducts and processes on humans and the environment led by science – except where the precautionary principle applies?