SNS vil høre vores kommentarer til spørgsmålene. Spørgsmål vedr. Cumulative long-term effects of GMO. Modtaget 16-01-2006, deadline 23-01-2006, svar 23-01-2006.

"DMU har følgende kommentarer til spørgsmålene: The comments below primarily refer to environmental issues. 1) Name and competent authority. Re 1): - 2) What do you understand by ‘long term’ - 10 years, 50 years, 100 years or other? Re 2): We will normally consider effects that occur 10 or more years after the release of a GMP as “long-term effects”. 3) What sort of effects do you think might emerge after this period of time? What are your reasons for thinking this? Re 3): This depends on the plant species and the genetically modified traits in combination with the environment and area of the release. Therefore both probability of occurrence and the potential consequences must in principle be assessed for each case. Similar cases of crop/trait-combinations will however most likely have the same environmental consequences provided that the environment and the farming conditions are similar. For example for Bt-maize, adverse effects may occur on non-target organisms such as rare butterflies living in the field surroundings or some soil organisms in the field. The probability for this would have to be assessed as low or insignificant before the GM-plant is released. 4) What monitoring arrangements do you have in place that would support identification of such effects, should they occur? Do you envisage that it will be possible to prove cause and effect given your current monitoring arrangements? Re 4): The data/results of general surveillance or any other monitoring programme will need to be carefully analysed to detect environmental effects which may have been caused by the release of a GMP. Direct effects to the GM field environment probably are the most likely and consequently the easiest to identify. However, monitoring or surveillance results in many cases will only provide indications of the origin of possible effects. Consequently, it is essential that monitoring is combined with research on the specific issues which are relevant. 5) What do you understand by cumulative effects? Re 5): The definition we use are set by the Directive 2001/18/EC and refers to “the accumulated effects of consents on [human health and] the environment, including inter-alia flora and fauna, soil fertility, soil degradation of organic material, the feed/ food chain, biological diversity, [animal health] and resistance problems in relation to antibiotics”. In the assessment we interpret this by analysis of estimated likelihood of each identified potential consequence and then estimate single risk elements and the total risk by the release. 6) What sort of cumulative effects do you think might emerge after what you have defined as the long term in Q2? What are your reasons for thinking this? Re 6): Depending on the case, a range of effects are possible including those outlined in Re 5). 7) Do you think the monitoring arrangements in place in your member state are adequate to identify these effects, should they occur? Re 7): The monitoring plan for authorisation for marketing in EU will normally not include identification of long-term cumulative effects. The national monitoring programs in Denmark can hopefully be used in some cases (e.g., NOVANA habitat and species monitoring program). 8) Do you think the current EU risk assessment framework enables applicants to address adequately the potential long-term cumulative effects of GMOs? Do applicants generally pay sufficient attention to this aspect of applications? What do you think would improve this aspect of the authorisation process? Re 8): It is presently not possible to fully address the potential long-term cumulative effects specifically by general surveillance combined with research within the current EU framework. However, an ongoing EU working group on monitoring will provide more detailed suggestions for monitoring plans of some common types of GM plants (crop/trait-combinations) and should hopefully improve the process. 9) Do you have specific criteria for deciding what are acceptable and unacceptable risks? If so, can you let us know what these are and why you have identified these? Re 9): The general criteria we use for acceptance are that the identified risks should have been assessed as “negligible” or “low” and that the monitoring plan includes surveillance of risks which may become unacceptable. 10) Are there any models used by other regulatory authorities worldwide that you would like to be incorporated into the European approach that might provide for a better assessment of long-term cumulative risks? Re 10): The procedures in Canada where environmental risks of non-GM-crops are assessed in parallel fashion to GM-crops have a point regarding that the environmental risks of non-GM crops should also be assessed. 11) Are you aware of any reports of unexpected effects of the release of a GMO? Re 11): This is a matter of definition. We are not aware of any major unexpected environmental effects of released crops. The potential adverse effects of Bt-pollen on monarch butterfly larvae, which turned out to be of minor importance in actual field situations, was an important reminder of a general problem to small populations of butterflies with larvae which feed on plants in field surroundings. Furthermore, contamination of non-GM crops by seed spillage or accidental mixing of seed parties, which are perhaps not unexpected, has been reported from USA, Canada and of cause the Teosinte maize from Mexico. "

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