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Interpretation of precaution
in CEE countries –
use it or abuse it?
Liina Eek
Ministry of Environment, Estonia
18 April 2006
Vienna
Main topics
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1. Basic definitions
2. P as part of decision making process in CEE
3. P in Rio Declaration and Cartagena Protocol
4. P in CEE legislation
5. Cartagena Protocol, EU interpretation and WTO
SPS agreement
• 6. Situation of NBFs in CEE countries
• 7. Conclusions
Definitions – precaution
• Precautionary principle/approach is a strategy to
address uncertainty regarding potential risks and
to avoid possible risks in the case of uncertainty.
• Part of risk management process that is used in
decision making.
Definitions – risk assessment
• Risk assessment
• 1. identification of threat (negative effect, hazard,
adverse event) and (2) its characterisation,
• 2. (3) estimation of the probability of exposure,
• 3. (4) based on these - estimation of risk (the
probability of an adverse effect and the magnitude of
the consequences).
Definitions – risk analysis
• Risk analysis
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1. Risk assessment
2. Risk management:
a) selection of risk mitigating measures
b) decision making (incl policy and acceptability of
risk)
• Throughout the process: Risk communication (on
both RA and RM, two-way communication)
Two legs of precaution
• 1. identification of a potential hazard
• 2. identification of scientific uncertainty that
makes it impossible to finalize the assessment of
the risk arising from this hazard
• There must be a hazard and uncertainty of risk .
P as part of decision making process
• Turkey: main principles in biosafety system
● 1. precautionary principle,
● 2. case-by-case evaluation and
● 3. strategic long-term risk assessment of GMOs,
including impacts on socio-economic structure.
P as part of decision making process
• Belarus: GMO act, art 4: basic principles of
ensuring safety in genetic engineering activities:
• 1. precautionary principle
• 2. conservation of biological diversity and natural
ecological systems;
• 3. scientifically-grounded, integrated and case-bycase approach to risk assessment,
• 4. liability for violation of legislation,
• 5. access of individual persons and civil
associations to information,
• 6. international cooperation.
P as part of decision making process
• Georgia: draft GMO act, art. 5, those principles
are applied to the field of GMOs:
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1. Precautionary principle
2. Principle of integrity
3. Principle of subsidiary measures
4. Bioethical principle
5. Risk assessment principle
6. Principle of liability
7. Publicity and public participation principle
P as part of decision making process
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Romania (principles for the endorsement of the
environmental risk evaluation study, annex to Law nr
214)– part of risk assessment, but not of decision
making process
P in Rio Declaration
• Rio de Janeiro (1992) Declaration Principle 15:
• In order to protect the environment, the
precautionary approach shall be widely applied by
States according to the 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.
P in Cartagena Protocol
• Cartagena Protocol
• Art 10.6/11.8: Lack of scientific certainty due to insufficient relevant
scientific information and knowledge regarding the extent of the
potential adverse effects of a LMO on the conservation and
sustainable use of biological diversity (...), taking also into account
risks to human health, shall not prevent (...) from taking a decision,
(...) in order to avoid or minimize such potential adverse effects.
• Annex III 4: lack of scientific knowledge or scientific consensus
should not necessarily be interpreted as indicating a particular level of
risk, an absence of risk, or an acceptable risk.
• 8f: Where there is uncertainty regarding the level of risk, it may be
addressed by requesting further information on the specific issues of
concern or by implementing appropriate level of risk management
strategies and/or monitoring the LMOs in the receiving environment.
P in CEE legislation
• Georgia draft GMO act:
• “precautionary principle” – use of GMOs shall
only be permitted if, taking into account the state
of science and technology, and the guarantee of
safety measures in Georgia, no direct or indirect,
immediate or delayed or long-term cumulative
adverse effects on the environment, biodiversity
and human health can be expected.“
P in CEE legislation
• Macedonia (former Republic of Yugoslav) draft
GMO act article 6:
• “Should there be any justified doubt of possible
harmful effects on the environment and human
life and health caused by the use of GMO, all
necessary measures and activities for protection
shall be undertaken prior to obtaining the credible
scientific evidence on the occurrence of such
harmful effects.”
P in CEE legislation
• Croatia Nature Protection Act (Article 137):
• „In special circumstances, where following an assessment of all
available information, the possibility of harmful effects of a food on
human health is identified, but scientific uncertainty persists the
competent authorities may take provisional measures of risk
management, much-needed for ensuring the highest possible level of
human health protection to until further scientifically founded
information necessary for the overall assessment of the risk is
acquired.
• The measures taken must be adequate and not restrict trade more
than is necessary to achieve high level of human health protection,
taking in to account their technical and economical feasibility and the
established state of the facts. The undertaken measures must be
reconsidered within a reasonable period of time, depending on the
nature of the identified risk for human health and life, and the type of
scientific information needed to clarify the scientific uncertainty, and to
conduct the overall risk assessment.“
CP and WTO
• CP preamble: “Recognizing that trade and environment
agreements should be mutually supportive with a view to
achieving sustainable development; ... not subordinate to
each other...”
• The international framework is largely harmonized on
fundamental concepts:
• CP and WTO: countries have the rights to set the level of
risk that they deem acceptable and to establish the level
of protection that they deem appropriate
• There are differences in emphasis, procedures, criteria,
trigger of precautionary measures
• EC communication (2000) approach to precaution is
similar to approach in WTO agreements
CP and WTO
• Japan apple case, Appellate Body:
• Interpretation of SPS art 5.7; conditions for
adopting and maintaining a provisional measure:
• 1. Relevant scientific evidence is insufficient,
• 2. measure adopted on basis of available
pertinent information,
• 3. country has to seek for additional information
for RA,
• 4. review after reasonable period of time.
CP and WTO
• Cartagena Protocol:
• 1. (art 10 and 11, annex III, 4. and 8 f) lack of
scientific certainty due to insufficient relevant
scientific information and knowledge,
• 2. No requirement for actively seeking
information
• 3. Nothing about time limits when taking
decisions
CP and WTO
• Protectionism: use of speculative threats, there
is no theory about these threats, based on blind
guess
• EC communication (2000): Precautionary
measures should be proportional and nondiscriminative and they should not set
unjustified trade barriers
Situation in CEE
• NBFs being established in most of CEE countries
• Most CEE countries have decided to draft new
biosafety legislation (vs amending existing)
• Limited capacity for risk assessment and risk
analysis
• CEE countries are worried about importing and
using GMOs before they have set their complete
NBF
Conclusions
1. All CEE countries mention precautionary
principle in their legislation
●2. Each country defines it differently
●3. All CEE countries admit possible conflict with
WTO, waiting for the results of biotech dispute
●4. Most of the CEE countries try to restrict import of
GMOs until they have set their functional NBF
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