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DESCRIPTIONPiacenza, October 14, 2011 "Innovating Food, Innovating the Law" Conference ALBERTO ALEMANNO (École des hautes études commerciales de Paris, France) Regulating Emerging Risks: The case of nano-food applications and animal cloning in food production Video: http://vimeo.com/31450146
- 1. The Challenges of Nanofood and Animal Cloning Alberto Alemanno HEC Paris Innovating Food, Innovating the Law International Conference Piacenza, October 14, 2011
- To provide you
- with the state of play of the ongoing debate
- 3. Nano-food
- 4. Food from cloned animals
- 6. central to
- 7. and to its theme
- How legal innovation may strike a balance btw
- 8. Both technologies
- (unknown) risks
- Hence, need to promote innovation while attaining a high level of protection
- (typical rethoric surrounding technological innovation in EU policy documents)
- What kind of regulatory approach to adopt ?
- the answer to this question depends on a variety of factors, regulatory philosophies, competing set of knowledge
- real risks vs perceived risks
- experts vs layman advice
- regulatory humilty vs command&control
- technocracy vs deliberate democracy
- harm vs risk
- paternalism vs nudges
- but is increasingly shaped by one
- fuelled by social amplification of risk, availability cascades and mental shortcuts
- 16. The fear of the month
- Do cell phones cause brain cancer?
- What about wi-fi? or MP3 players?
- High doses of vitamins? Mercury in fish? GMOs? Nanotechnologies?
- How to decide whether (or not) to regulate the fear of the month?
- 18. Rationality & Scientific Truth Substantial equivalence with conventional food
- 19. Public Knowledge FEAR about SAFETY CONCERNS about ANIMAL WELFARE
- What kind of regulatory approach to adopt ?
- 22. Novel Food Regulation (258/97)
- Food and food ingredients not used before May 15 1997
- 24. Extending the scope
- Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques , and foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food.
- (Point 6 Preamble)
- 25. FAILURE Spring 2011
- Covered by existing (non-dedicated) regulations, such as REACH, NOVEL FOOD, COSMETIC, etc.
- Lets zoom in
- The challenges
- inherent to
- 29. Nano-food
- 30. What are Nanotechnologies? Not new materials but smaller forms of familiar materials whose properties differ significantly from those at a larger scale. The smaller the particle, the larger its surface area and reactivity. Most definitions revolve around the study and control of phenomena and materials at length scales below 100 nm and quite often they make a comparison with a human hair, which is about 80,000 nm wide 1 nm = 1 billionth of a meter
- 31. What are Nanotechnologies?
- 32. Potential applications of nanotechnologies
- 33. What Makes Nano Different?
- Manipulation of matter at the nanoscale to create new and unique materials and products
- - Gold changes colour (it turns red)
- - Carbon nanostructures become strongest and stiffest of currently existing materials
- - Copper becomes transparent
- As well as the size as well as the conformation and form in the environment
- YET CONTROVERSY upon DEFINITION because scientifically:
- there is no scientific basis for drawing a line at any given size
- nano subject to the same risk assessment paradigm (EFSA)
- it may trigger labelling requirement
- thus determining scope of regulation and future of technology
- See EFSA Guidance Documents on Risk Assessment on Nanofood
- 34. The Science
- 35. The Scientific Challenge
- If the smaller size may be advantageous, the nanoscale dimensions and consequently high surface area may lead to deleterious consequences, particularly in terms of their toxicity .
- This is particularly so in relation to engineered particles which are non-biodegradable/insoluble since they are not metabolised (so called particulate nanomaterials)
- Uncertainty about translocation in body
- - Crossing of blood-brain barrier/ Ability to enter cells
- Uncertainty about life-cycle effects
- Uncertainty about relevant physicochemical properties
- The EU has decided to take an integrated, safe and responsible approach to the development of nanotechnologies since 2004. This includes:
- reviewing and adapting EU laws
- (2008 Commission Communication Regulatory Aspects of Nanomaterials)
- monitoring safety issues
- research programmes and funding
- engaging in dialogue with national authorities, stakeholders and citizens.
- 37. Consumer Information Regulation
- Additional qualification:
- Characterisation of internal nanostructures
- Measure of surface to volume ratios
- 38. The industry perspective
- 39. Food from cloned animals
- 40. 1997
- 41. Animal Cloning in Europe
- European Public & Legal Debate on:
- Under which conditions
- food produced using animal cloning should be allowed within the internal market
- In the affirmative,
- Novel Food regulation?
- Ad hoc/special legislation?
- 42. What is cloning? (I)
- Cloning is the creation of an organism that is a genetic copy of another.
- This means the two organisms share exactly the same DNA.
- Technique most commonly used is SCNT:
- Somatic cell nucleus transfer (SCNT), which allows scientists to create genetic replicas (clones) from adult animals that share the same nuclear gene set as anoth
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