1. Interpretation of precaution in CEE countries – use it or abuse it? Liina Eek Ministry of Environment, Estonia 18 April 2006 Vienna

2. Main topics 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

3. 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.

4. 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).

5. Definitions – risk analysis Risk analysis 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)

6. 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.

7. 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.

8. 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-by- case approach to risk assessment, 4. liability for violation of legislation, 5. access of individual persons and civil associations to information, 6. international cooperation.

9. P as part of decision making process Georgia: draft GMO act, art. 5, those principles are applied to the field of GMOs: ● 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

10. P as part of decision making process 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

11. 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.

12. 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.

13. 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.“

14. 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.”

15. 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.“

16. 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

17. 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.

18. 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

19. 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 non- discriminative and they should not set unjustified trade barriers

20. 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

21. 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