19 - innovating food, innovating the law - alberto alemanno
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Piacenza, 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/31450146TRANSCRIPT
The Challenges of Nanofood and Animal
Cloning
Alberto AlemannoHEC Paris
Innovating Food, Innovating the Law – International Conference
Piacenza, October 14, 2011
To provide you
with the ‘state of play’ of the ongoing debate
Nano-food
Food from cloned animals
central to
and to its theme
How ‘legal innovation’ may strike a balance btw
INNOVATION
&
PROTECTION
Both technologies
opportunities
&
(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
salience
saliencefuelled by social amplification of
risk, availability cascades and mental shortcuts
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’?
Rationality & Scientific Truth
Substantial equivalence with conventional food
Public Knowledge
FEAR about SAFETY CONCERNS about ANIMAL
WELFARE
What kind of regulatory
approach to adopt ?
Against this backdrop
Novel Food Regulation(258/97)
Food and food ingredients not used before May 15 1997
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)
FAILURE Spring 2011
Covered by existing (non-dedicated) regulations, such as REACH, NOVEL FOOD,
COSMETIC, etc.
yet
Let’s zoom in
The challenges
inherent to
Nano-food
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
What are Nanotechnologies?
Potential applications of nanotechnologies
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
The Science
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.
Regulatory Challenges
Consumer Information RegulationAdditional qualification:-Characterisation of internal nanostructures-Measure of surface to volume ratios
The industry perspective
Food from cloned animals
1997
DOLLY
Animal Cloning in Europe
• European Public & Legal Debate on:• Whether• Under which conditionsfood produced using animal cloning should be allowed within the internal market
• In the affirmative,• Novel Food regulation?• Ad hoc/special legislation?
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 another organism
What’s the link btw animal cloning and food?
• Cloning may be used to breed farm animals for food production
• The benefits of using animal cloning as a breeding technique consist in producing elite animals to be used in breeding
• The clones not used for food production, but their offsprings whose qualities might be:• Resistance to disease• Production of milk, quality of meat, etc
Public concerns(European Group of Ethics in Science and New
Technologies, 2008)
The genesis of the cloning debate (II)
• 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.
• July 2008, EFSA released its Scientific Opinion
• September 2008, in a resolution it adopted, the European Parliament supported a total ban of cloning (622 MEPs vs 32).
• March 2009, new request to EFSA: statement
• In 2009, in order to have a broader view of the issue, the Council asked the Commission to present a report.
• At his EP's hearing earlier this year, Commissioner Dalli promised that the report would be delivered by the end of 2010.
Food from Cloned Animals
No specific regulation* for the time being
BUT
debate over whether
* 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
Consilium novel food
EP Ad hoc legislation
• EP:
Outright ban, then – as final offer – mandatory labelling
Commission – October 18, 2010
« 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
Commission position today
• Temporary suspension of:• the use of cloned farm animals and offsprings• The marketing of food from clones
• Establishment of a tracing system for imported genetic materials (semen; cloned embryos)
• Assessment of cloning technology in relation to food production and examines the relevant aspects of cloning in light of the existing legislative framework.
• 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.
• The communication examines cloning both in the Member States and in third countries.
impasse
In the meantime
• As the debate unfolds, nanofood and cloned food are a reality
• Yet, little knowledge on what’s on the market
• Calls for • EU-wide registry for nano• More transparency on trade of genetic
material from cloned animals
my claim
Signs of change
-Calls for ad hoc regulations downplayed
no ad hoc regulation proposed/adopted, with the only exception of
on cloning in
Sign of change
-Moderate/absence use of precautionary language
Sign of change
Precautionary Principle
-‘Upstream public engagement’ within stakeholder consultation
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)
(especially in nano debate)
Sign of change
Governance of nanoexample of upstream public
engagement
-Heightened awarnes of the social and cultural factors that drive risk assessment
Sign of change
competing bodies
of knowledgePublic & Expert Rationalities demarcate
the boundaries of citizen participation
- Attention to benefits vs risks
Sign of change
vs vs Risks
more emphasis on virtues
PUBLIC CONSULTATION ONTOWARDS A STRATEGIC NANOTECHNOLOGY ACTION PLAN 2010-2015
Risks vs Risks trade-offs
What are the risks of not embracing the technology?
no longer
That’s where the
stands today
yet
it remains to be seen if these signs express
fear to kill
of a more humble, patient and reflexive
approach
Bibliography
Alemanno A., The Two Souls of European Risk Regulation – A Reply to Ragnar Lofstedt, European Journal of Risk Regulation, 2/2011.
Alemanno A., Case annotation on the judgment of 22 December 2010, Court of Justice of the European Union, in Case C-79/09 Gowan Comércio Internacional e Serviços Lda v. Ministero della Salute, 48 Common Market Law Review 4 (2011).
Alemanno A., Public Perception of Food Safety Risks Under WTO Law: A Normative Perspective, forthcoming in Geert van Calster and Denise Prévost (eds), Research Handbook on Environment, Health and the WTO (Edward Elgar, UK, 2012).