19 - Innovating Food, Innovating the Law - Alberto Alemanno

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Piacenza, October 14, 2011 "Innovating Food, Innovating the Law" Conference ALBERTO ALEMANNO (cole des hautes tudes commerciales de Paris, France) Regulating Emerging Risks: The case of nano-food applications and animal cloning in food production Video: http://vimeo.com/31450146

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<ul><li> 1. The Challenges of Nanofood and Animal Cloning Alberto Alemanno HEC Paris Innovating Food, Innovating the Law International Conference Piacenza, October 14, 2011 </li> <li> 2. <ul><li>To provide you </li></ul><ul><li>with the state of play of the ongoing debate </li></ul></li> <li> 3. Nano-food </li> <li> 4. Food from cloned animals </li> <li> 5. </li> <li> 6. central to </li> <li> 7. and to its theme <ul><li>How legal innovation may strike a balance btw </li></ul><ul><li>INNOVATION </li></ul><ul><li>&amp; </li></ul><ul><li>PROTECTION </li></ul></li> <li> 8. Both technologies <ul><li>opportunities </li></ul><ul><li>&amp; </li></ul><ul><li>(unknown) risks </li></ul></li> <li> 9. <ul><li>Hence, need to promote innovation while attaining a high level of protection </li></ul><ul><li>(typical rethoric surrounding technological innovation in EU policy documents) </li></ul></li> <li> 10. <ul><li>What kind of regulatory approach to adopt ? </li></ul></li> <li> 11. <ul><li>the answer to this question depends on a variety of factors, regulatory philosophies, competing set of knowledge </li></ul></li> <li> 12. <ul><li>real risks vs perceived risks </li></ul><ul><li>experts vs layman advice </li></ul><ul><li>regulatory humilty vs command&amp;control </li></ul><ul><li>technocracy vs deliberate democracy </li></ul><ul><li> harm vs risk </li></ul><ul><li>paternalism vs nudges </li></ul></li> <li> 13. <ul><li>but is increasingly shaped by one </li></ul></li> <li> 14. <ul><li>salience </li></ul></li> <li> 15. <ul><li>salience </li></ul><ul><li>fuelled by social amplification of risk, availability cascades and mental shortcuts </li></ul></li> <li> 16. The fear of the month <ul><li>Do cell phones cause brain cancer? </li></ul><ul><li>What about wi-fi? or MP3 players? </li></ul><ul><li>High doses of vitamins? Mercury in fish? GMOs? Nanotechnologies? </li></ul></li> <li> 17. <ul><li>How to decide whether (or not) to regulate the fear of the month? </li></ul></li> <li> 18. Rationality &amp; Scientific Truth Substantial equivalence with conventional food </li> <li> 19. Public Knowledge FEAR about SAFETY CONCERNS about ANIMAL WELFARE </li> <li> 20. <ul><li>What kind of regulatory approach to adopt ? </li></ul>Against this backdrop </li> <li> 21. </li> <li> 22. Novel Food Regulation (258/97) <ul><li>Food and food ingredients not used before May 15 1997 </li></ul></li> <li> 23. </li> <li> 24. Extending the scope <ul><li>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. </li></ul><ul><li>(Point 6 Preamble) </li></ul></li> <li> 25. FAILURE Spring 2011 </li> <li> 26. <ul><li>Covered by existing (non-dedicated) regulations, such as REACH, NOVEL FOOD, COSMETIC, etc. </li></ul>yet </li> <li> 27. <ul><li>Lets zoom in </li></ul></li> <li> 28. <ul><li>The challenges </li></ul><ul><li>inherent to </li></ul></li> <li> 29. Nano-food </li> <li> 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 </li> <li> 31. What are Nanotechnologies? </li> <li> 32. Potential applications of nanotechnologies </li> <li> 33. What Makes Nano Different? <ul><li>Manipulation of matter at the nanoscale to create new and unique materials and products </li></ul><ul><li>- Gold changes colour (it turns red) </li></ul><ul><li>- Carbon nanostructures become strongest and stiffest of currently existing materials </li></ul><ul><li>- Copper becomes transparent </li></ul><ul><li>As well as the size as well as the conformation and form in the environment </li></ul><ul><li>YET CONTROVERSY upon DEFINITION because scientifically: </li></ul><ul><li>there is no scientific basis for drawing a line at any given size </li></ul><ul><li>nano subject to the same risk assessment paradigm (EFSA) </li></ul><ul><li>it may trigger labelling requirement </li></ul><ul><li>thus determining scope of regulation and future of technology </li></ul><ul><li>See EFSA Guidance Documents on Risk Assessment on Nanofood </li></ul></li> <li> 34. The Science </li> <li> 35. The Scientific Challenge <ul><li>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 . </li></ul><ul><li>This is particularly so in relation to engineered particles which are non-biodegradable/insoluble since they are not metabolised (so called particulate nanomaterials) </li></ul><ul><li>Uncertainty about translocation in body </li></ul><ul><li>- Crossing of blood-brain barrier/ Ability to enter cells </li></ul><ul><li>Uncertainty about life-cycle effects </li></ul><ul><li>Uncertainty about relevant physicochemical properties </li></ul></li> <li> 36. <ul><li>The EU has decided to take an integrated, safe and responsible approach to the development of nanotechnologies since 2004. This includes: </li></ul><ul><li><ul><li>reviewing and adapting EU laws </li></ul></li></ul><ul><li><ul><li>(2008 Commission Communication Regulatory Aspects of Nanomaterials) </li></ul></li></ul><ul><li><ul><li>monitoring safety issues </li></ul></li></ul><ul><li><ul><li>research programmes and funding </li></ul></li></ul><ul><li><ul><li>engaging in dialogue with national authorities, stakeholders and citizens. </li></ul></li></ul>Regulatory Challenges </li> <li> 37. Consumer Information Regulation <ul><li>Additional qualification: </li></ul><ul><li>Characterisation of internal nanostructures </li></ul><ul><li>Measure of surface to volume ratios </li></ul></li> <li> 38. The industry perspective </li> <li> 39. Food from cloned animals </li> <li> 40. 1997 <ul><li>DOLLY </li></ul></li> <li> 41. Animal Cloning in Europe <ul><li>European Public &amp; Legal Debate on: </li></ul><ul><li><ul><li>Whether </li></ul></li></ul><ul><li><ul><li>Under which conditions </li></ul></li></ul><ul><li><ul><li>food produced using animal cloning should be allowed within the internal market </li></ul></li></ul><ul><li>In the affirmative, </li></ul><ul><li><ul><li>Novel Food regulation? </li></ul></li></ul><ul><li><ul><li>Ad hoc/special legislation? </li></ul></li></ul></li> <li> 42. What is cloning? (I) <ul><li>Cloning is the creation of an organism that is a genetic copy of another. </li></ul><ul><li>This means the two organisms share exactly the same DNA. </li></ul><ul><li>Technique most commonly used is SCNT: </li></ul><ul><li>Somatic cell nucleus transfer (SCNT), which allows scientists to create genetic replicas (clones) from adult animals that share the same nuclear gene set as another organism </li></ul></li> <li> 43. What s the link btw animal cloning and food? <ul><li>Cloning may be used to breed farm animals for food production </li></ul><ul><li>The benefits of using animal cloning as a breeding technique consist in producing elite animals to be used in breeding </li></ul><ul><li>The clones not used for food production, but their offsprings whose qualities might be: </li></ul><ul><li><ul><li>Resistance to disease </li></ul></li></ul><ul><li><ul><li>Production of milk, quality of meat, etc </li></ul></li></ul></li> <li> 44. Public concerns ( European Group of Ethics in Science and New Technologies, 2008) </li> <li> 45. The genesis of the cloning debate (II) <ul><li>According to the current EU Regulation, only food produced from clones is considered "novel food" as it is not produced via traditional breeding techniques. Therefore, such food falls under the scope of the Regulation on Novel foods, which is now under discussion at EU level. </li></ul><ul><li>July 2008, EFSA released its Scientific Opinion </li></ul><ul><li>September 2008, in a resolution it adopted, the European Parliament supported a total ban of cloning (622 MEPs vs 32). </li></ul><ul><li>March 2009, new request to EFSA: statement </li></ul><ul><li>In 2009, in order to have a broader view of the issue, the Council asked the Commission to present a report. </li></ul><ul><li>At his EP's hearing earlier this year, Commissioner Dalli promised that the report would be delivered by the end of 2010. </li></ul></li> <li> 46. Food from Cloned Animals <ul><li>No specific regulation * for the time being </li></ul><ul><li> BUT </li></ul><ul><li>debate over whether </li></ul><ul><li>* Under proposed New Novel Food Regulation, food obtained directly from cloned animals is Novel Food, but not food obtained from progeny (because not the product of traditional breeding technique) subject to amendments </li></ul></li> <li> 47. Consilium novel food </li> <li> 48. EP Ad hoc legislation <ul><li>EP: </li></ul>Outright ban, then as final offer mandatory labelling </li> <li> 49. Commission October 18, 2010 <ul><li> The Communication adopted today is a response to calls from the European Parliament and Member States to launch a specific EU policy on this sensitive issue. I believe that the temporary suspension constitutes a realistic and feasible solution to respond to the present welfare concerns. John Dalli, DG SANCO Commissioner </li></ul></li> <li> 50. Commission position today <ul><li><ul><li>Temporary suspension of: </li></ul></li></ul><ul><li><ul><li><ul><li>the use of cloned farm animals and offsprings </li></ul></li></ul></li></ul><ul><li><ul><li><ul><li>The marketing of food from clones </li></ul></li></ul></li></ul><ul><li><ul><li>Establishment of a tracing system for imported genetic materials (semen; cloned embryos) </li></ul></li></ul><ul><li><ul><li>Assessment of cloning technology in relation to food production and examines the relevant aspects of cloning in light of the existing legislative framework . </li></ul></li></ul><ul><li><ul><li>It acknowledges the challenges posed by animal welfare issues and takes into consideration the ethical facet of cloning. It also notes that there is no scientific evidence confirming food safety concerns regarding foods obtained from cloned animals or their offspring. </li></ul></li></ul><ul><li><ul><li>The communication examines cloning both in the Member States and in third countries . </li></ul></li></ul></li> <li> 51. <ul><li> impasse </li></ul></li> <li> 52. In the meantime <ul><li>As the debate unfolds, nanofood and cloned food are a reality </li></ul><ul><li>Yet, little knowledge on whats on the market </li></ul><ul><li>Calls for </li></ul><ul><li><ul><li>EU-wide registry for nano </li></ul></li></ul><ul><li><ul><li>More transparency on trade of genetic material from cloned animals </li></ul></li></ul></li> <li> 53. <ul><li>my claim </li></ul>Signs of change </li> <li> 54. <ul><li>Calls for ad hoc regulations downplayed </li></ul><ul><li>no ad hoc regulation proposed/adopted, with the only exception of </li></ul><ul><li>on cloning in </li></ul>Sign of change </li> <li> 55. <ul><li>Moderate/absence use of precautionary language </li></ul>Sign of change </li> <li> 56. Precautionary Principle </li> <li> 57. <ul><li> Upstream public engagement within stakeholder consultation </li></ul><ul><li>not only used as a legitimating technique operating within a deficit model in which citizens are treated as being in need of education but as a technology of humility capable of offsetting excessive reliance on science in areas of uncertainty (Jasanoff) </li></ul><ul><li>(especially in nano debate) </li></ul>Sign of change </li> <li> 58. Governance of nano example of upstream public engagement </li> <li> 59. <ul><li>Heightened awarnes of the social and cultural factors that drive risk assessment </li></ul>Sign of change </li> <li> 60. <ul><li>competing bodies of knowledge </li></ul><ul><li>Public &amp; Expert Rationalities demarcate the boundaries of citizen participation </li></ul></li> <li> 61. <ul><li>- Attention to benefits vs risks </li></ul>Sign of change </li> <li> 62. <ul><li><ul><li>vs vs Risks </li></ul></li></ul><ul><li><ul><li>more emphasis on virtues </li></ul></li></ul></li> <li> 63. PUBLIC CONSULTATION ON TOWARDS A STRATEGIC NANOTECHNOLOGY ACTION PLAN 2010-2015 </li> <li> 64. <ul><li><ul><li>Risks vs Risks </li></ul></li></ul><ul><li><ul><li>trade-offs </li></ul></li></ul><ul><li><ul><li>What are the risks of not embracing the technology? </li></ul></li></ul></li> <li> 65. no longer </li> <li> 66. Thats where the <ul><li>stands today </li></ul></li> <li> 67. yet <ul><li>it remains to be seen if these signs express </li></ul></li> <li> 68. <ul><li>fear to kill </li></ul></li> <li> 69. <ul><li>of a more humble, patient and reflexive approach </li></ul></li> <li> 70. <ul><li>Thank you for your attention! </li></ul><ul><li>comments welcome </li></ul><ul><li>at </li></ul><ul><li>[email_address] </li></ul></li> <li> 71. Bibliography <ul><li>Alemanno A., The Two Souls of European Risk Regulation A Reply to Ragnar Lofstedt,...</li></ul></li></ul>