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- W1594064804 abstract "According to EU Directive 2001/18/EC and its Appendix VII, there will be mandatory monitoring of genetically modified organisms (GMOs) placed on the market to: (i) trace and identify eventual effects of the placing on the market of GMOs; and (ii) give feedback to the risk assessment procedure. A short overview is given of the accompanying Guidance Note for monitoring that has been implemented recently. This contribution will be restricted to aspects related to genetically modified higher plants (GMPs), and to their interactions, and to those aspects that directly relate to the escape and consecutive introgression of transgenes. Introgression of transgenes in a wild relative can be through GMP pollen siring hybrids directly, and indirectly through initial dispersal of the whole GMP (as seed or vegetative diaspore), and subsequent hybridization. According to the EU, the monitoring will have two focuses: (i) the possible effects of the GM crop, identified in the formal risk assessment (RA) procedure; and (ii) unforeseen effects. Where there is scientifically valid evidence of a potential adverse effect linked to the genetic modification, then, in the first part, 'case-specific monitoring' should be carried out after commercialization in order to confirm the assumptions of RA. Any evaluation of the potential consequence of that effect should be science based and compared with baseline information. In the second part, unanticipated effects of the environmental release are subject to a general surveillance programme that should be implemented independently of whether the RA found an indication of a harmful effect or not. The Guidance Note explicitly suggests that this latter part may well be long-term monitoring, given the fact that unexpected effects can be of delayed and long-term type. It is emphasized that, basic to the monitoring and the consecutive evaluation, is the availability of baseline data which give reference values for weighing of the GMP effects. It is acknowledged that there is great demand for such data sets. In any case, in order to be able to follow the consequences of transgene introgression, their identification is a prerequisite. Therefore, cost-effective and unambiguous markers may be placed in the GMPs, such as PCR-able eventually non-coding sequences in the constructs. In general, gene flow is mostly unavoidable. It is therefore the quality of the GMP traits that counts. A large amount of gene flow from a GMP with environmentally neutral traits is of less concern than minimal gene flow of plant fitness-enhancing traits. The Directive places the full responsibility for the establishment of the entire monitoring plan and the data report (to the competent state authorities) with the consent holder, in many cases private companies. It is questioned whether this is practical and feasible; therefore, it is suggested that part of the general surveillance, as well as additional monitoring elements outside the regulatory requirements, should be integrated in existing (state-owned) monitoring networks." @default.
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- W1594064804 date "2004-01-01" @default.
- W1594064804 modified "2023-09-27" @default.
- W1594064804 title "Introgression of GM plants and the EU guidance note for monitoring." @default.
- W1594064804 doi "https://doi.org/10.1079/9780851998169.0365" @default.
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