nanotechnology: an integrated product policy approach rosalind malcolm professor of law
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Nanotechnology: an integrated product policy approach Rosalind Malcolm Professor of Law School of Law University of Surrey UK. The problem of definition. Defining nanotechnology Determining the risk Designing the regulation. Risk based liability. - PowerPoint PPT PresentationTRANSCRIPT
Nanotechnology: an integrated product policy approach
Rosalind MalcolmProfessor of LawSchool of LawUniversity of SurreyUK
The problem of definition
• Defining nanotechnology
• Determining the risk
• Designing the regulation
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)
Risk and law
But………
• Where risk certain then prescriptive action
And
• The problem of self-regulation
Risk: prevention and precaution
• Known risk?
Preventive principle
• Uncertain risk?
Precautionary principle
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.
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.
What about the precautionary principle?
Proportionality
Requires
cost-benefit-analysis /
risk assessment /
balance free trade with
environmental integration
A precautionary tale
Case T-13/99
Pfizer Animal Health SA/NV v Council (2002)
Assessing risk and nanomaterials?
When risk assessment is the basis for legislation how does it apply to nano
products?
Relevance of the precautionary principle
A nanotechnology law?
Or
Law for nanotechnology?
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)
An integrated product approach
The lifecycle of a nanoproduct
Cradle to grave
Or
Cradle and grave?
Target pointsfor vertical laws
• The laboratory
• The factory
• The shop
• The home / office
• The landfill site
The vertical approach
• Research and development
• Manufacture
• Retail
• Use phase
• Disposal phase
• Transport
Regulatory gaps
• Are there gaps?
• Is new regulation required?
• What are the risks?
• Why do we need a law(s) for nanotechnology?
Identifying the gaps
• Scientific knowledge
• New legislation or adapt existing legislation?
• New codes/guidance?
• New international standards?
• Ethics? (Remember GMOs)
Regulatory challenges
Preserve and promote benefits
Protect from harm
Using an integrated product policy
• Identify risks
• Consider life cycle– Cradle to grave
• Take horizontal approach to product regulation
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).
Integrated product policy
3 models:
• REACH
• Environmental Impact Assessment (EIA)
• Product safety
Models for IPP
REACH (Regulation 1907/2006)
‘May not manufacture, place on market, use substances which adversely affect human health or the environment’
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
Models for IPP
Product safety
(General Product Safety EC Directive 2001/95)
Risk assessment basis for product legislation
Reflective approach
• IPP is a procedure
• Lack of substantive challenge
But …
• Procedures are reflective, self-educational
IPP for nanotechnology?
• Nanoproducts?
• Nanoprocesses?
• EIA for nanoproducts?
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?