precaution and the regulation of living modified organisms

AquaBounty ‘AquAdvantage’ Salmon
Timeline of PP
1970s W. German
1982 UN World Charter for
1985 Vienna Convention on
1992 Convention on
Biological Diversity
1992 UN Framework Charter
on Climate Change
1998 Persistent Organic
Protection of the Ozone Layer
Pollutants Protocol
2000 Cartagena Protocol on
1990 Bergen Ministerial
Declaration on Sustainable
1992 UN Rio Declaration on
Environment and
And the rest…
Defining PP
Rio 1992: In order to protect the
environment, the precautionary
approach shall be widely applied by
States according to their capabilities.
Where there are threats of serious or
irreversible damage, lack of full scientific
certainty shall not be used as a reason
for postponing cost-effective measures
to prevent environmental degradation.”
Wingspread Declaration
1998:When an activity raises threats
of harm to human health or the
environment, precautionary measures
should be taken even if some cause and
effect relationships are not fully
established scientifically.
EC Communication on PP
2000:when there are reasonable
grounds for concern that potential
hazards may affect the environment or
human, animal or plant health, and when
at the same time the available data
preclude a detailed risk evaluation, the
precautionary principle has been
politically accepted as a risk
management strategy in several fields.
COMEST 2005: When human
activities may lead to morally
unacceptable harm that is scientifically
plausible but uncertain, actions shall be
taken to avoid or diminish that harm.
Trends in PP
What PP does not aim to be
Zero risk
A decision-making tool
A barrier to trade
Stifling of scientific innovation
Placing unfair burden of proof of safety
Leading to paralysis
Is PP a legal principle or not?
Their utility is based on three fundamental aspects. First,
principles should be considered as one of the standards,
among others, that allow the evaluation of the validity of a
law. Second, principles have the potential to assist in the
interpretation of other rules. And, third, principles have the
capacity to fill legal gaps.
Comest 2005
Not sure:
Sands, de Sadeleer –yes. Birnie & Boyle –unsure. Sunstein –no.
European Commission- yes. Mox 2001/2003 –yes off the record.
Southern Bluefin Tuna –yes but not explicit. Beef Hormones –
Precaution and the Precautionary Principle
in the Regulation of LMOs
Cartagena Protocol 2000 – PP
EC Directives & Regulations - PP
Federal Food Drug and Cosmetic Act – not PP
US State Laws – not PP
Cartagena Protocol on Biosafety 2000
Aim: ensuring an adequate level of protection in the field of
the safe transfer, handling and use of living modified organisms
resulting from modern biotechnology that may have adverse
effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, and
specifically focusing on transboundary movements
PP measures:
Rio pr.15
Advance Informed Agreement
Biosafety Clearing House
Monitoring, Labelling, Traceability
EC Directives & Regulations
Aim: In accordance with the precautionary principle, the objective of this Directive
is to approximate the laws, regulations and administrative provisions of the Member
States and to protect human health and the environment when:
- carrying out the deliberate release into the environment of genetically modified
organisms for any other purposes than placing on the market within the Community,
- placing on the market genetically modified organisms as or in products within the
PP measures:
Cites PP Risk Ass. –Notes and Guidelines
EFSA -independent assessment
Aim: provide a framework for the traceability of products consisting of or
containing genetically modified organisms (GMOs), and food and feed produced from
GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on
the environment and, where appropriate, on health, and the implementation of the
appropriate risk management measures including, if necessary, withdrawal of
PP measures:
PP Risk Management Labelling Traceability
Unique Identifier Code for GMO labels
Transboundary Movements= Notify Commission
Biosafety Clearing House
US Food Drug and Cosmetic Act
Aim: Regulate Drugs and Cosmetics.
Center for Veterinary Medicine NADA
PP measures:
Risk Assessment Environmental Assessment
Labelling Traceability
Recall or further data requested, at any time
US State Laws
Some thoughts about PP…
American hostility
“We consider it to be a mythical concept,
perhaps like a unicorn”
Has PP evolved (or fragmented)?
Risk Assessment
Clearing Houses
Thank you!