Post-release monitoring and long-term effects of LMOs released into the environment
by Helmut Gaugitsch, Umweltbundesamt (Federal Environment Agency), Vienna, Austria). E-mail: helmut.gaugitsch@umweltbundesamt.at
Although the issue of potential long-term effects of LMOs released into the environment is regarded as important in the scientific and regulatory debate worldwide, in fact there have been quite few comprehensive studies carried out in this area. Risk assessment frameworks and methods (such as Annex III of the Cartagena Protocol on Biosafety) basically require in an explicit or implicit manner long-term effects to be taken into account but very often do not specify how that should be done. Certain methodological shortcomings are faced when it comes to assessing unanticipated and long-term effects of LMO releases. As a starting point for example there is a wide range of interpretation what long-term in fact means in terms of the time-frame (e.g. years).
A recent study (Cumulative long-term effects of GM crops on human/animal health and the environment: risk assessment methodologies. Central Science Laboratory/UK, 2006) inter alia came to the conclusion that risk assessment focusing on long-term effects must be scientifically valid but also proportionate with respect to cost-effectiveness. Gaps of knowledge primarily cover the need for obtaining solid baseline data as means for comparison. The best indicators have to be identified for that purpose. In addition more in depth-knowledge on introgression into and ecology of wild relatives has to be gained. Improved hazard identification for long-term and cumulative effects of LMO is another challenge. In most cases the hazards will not be different from those to be taken into account in risk assessment focusing on short-term effects. However, in the long-term also small but complex combination of factors may lead to negative effects and therefore have to be included in a scientific way in hazard identification and risk assessment. Tracking and monitoring cumulative and long-term risks of several LMOs released at the same time and broader stakeholder involvement in the risk assessment process in order to broaden the level of expertise are further challenges to be faced.
A systematic and as far as possible standardized approach based on valid science involving the relevant disciplines is the appropriate way forward and should be pursued nationally and internationally.
For the monitoring of LMOs it is necessary to identify the relevant parameters to be monitored depending on the LMO and its modified characteristics. LMOs, parts of LMOs (e.g. pollen, plant residues) and transgene-products (e.g. Bt-toxins) are able to spread, persist and accumulate in the environment.
As a result specific parameters selected on a case-by-case basis may need to be considered as part of a monitoring plan in order to monitor any establishment into and persistence in non-target environments or ecosystems.
The possibility of long-term persistence and accumulation of LMOs, parts of LMOs and transgene-products in the environment and the potential uncontrolled spread over long distances harbours a major potential for unforeseen environmental impacts, the temporal scale of which currently cannot be estimated. Furthermore, they are important indicators for cumulative effects.
Recording and monitoring dispersal, persistence and accumulation of LMOs, parts of LMOs and transgene-products in the environment may not primarily provide documentary proof of an adverse impact of an LMO but may be necessary in a precautionary documentation of a process, which may entail adverse environmental effects in the future. It provides knowledge on dispersal pathways of LMOs, parts of LMOs and transgene-products into media in which they possibly can survive, reproduce, multiply or accumulate.
For certain LMOs with specific traits (e.g. LMOs producing pharmaceutical substances, e.g. pharma crops), the tracing of not only the LMO itself or its transgene products but also of transgenic sequences in the environment might be also relevant as also the sequences may entail potential adverse effects on the environment, human or animal health.
Thus the information gained from monitoring of LMOs, parts of LMOs or transgene products represents an important basis for drawing conclusions on interrelationships between unforeseeable environmental effects either occurring immediately or those occurring with a time-lag and the environmental release of a LMO. Thus the detection and monitoring of LMOs, parts of LMOs and transgene-products in different environmental compartments are an essential element of LMO monitoring.
Like for the risk assessment, monitoring should be performed by systematic and standardized procedures, based on scientific experience and knowledge.
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