19 - innovating food, innovating the law - alberto alemanno

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

Thank you for your attention!

comments welcome

at

alemanno@hec.fr

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).