Risk assessment and risk management of specific receiving environments

My name is Helmut Gaugitsch and I am head of the Department Landuse & Biosafety of the Umweltbundesamt – the Federal Environment Agency of Austria, which is the national focal point for the Cartagena Protocol. I have been working in the field of GMO risk assessment for more than 15 years.

I very much appreciate that the receiving environment is a prominent topic of this forum. Currently there is an ongoing discussion in the EU on how to consider specific environments and also protected areas in the risk assessment and the risk management of LMOs. Although within the EU there are no “megadiverse” countries in a strict sense, there is a wide range of climatic zones and therefore different biogeographic areas, which are often neglected in risk assessment studies. There are also communities of wild relatives (e.g. oilseed rape, mainly in central Europe; beet, mainly in northern Europe) of LMOs which are currently placed on the market which might be adversely affected through vertical gene-flow. I therefore want to point out, that it is of crucial importance in risk assessment of LMOs to have a close look at the receiving environment, and to include the respective data from regions in the evaluation. This also means that the applicant needs to present data from regions representing the receiving environments in order to cover the varying climatic conditions, but also the varying groups of organisms, which might be affected by the LMO. The current practice does often not fulfill this requirement.

Another point I want to raise is more focused on risk management. We have to be aware that the receiving environments are agricultural environments, which are very different depending on the agricultural tradition and economic factors in certain regions. Small scale farming and ecological farming usually lead to a higher biodiversity within the field but also in the surroundings in comparison with large scale intensive farming, which is often based on fertilizer and pesticide input. The agricultural practice and its potential to further contribute to a loss in biodiversity should also be addressed in the LMO assessment. I am well aware that in addition to agro-ecological considerations this also touches upon socio-economic issues, but  the Cartagena Protocol provides for taking these issues into account.

To summarize I think that carefully studying the receiving environment, regarding its biodiversity but also the agricultural practice, is a prerequisite for a comprehensive risk assessment and consequently also for the risk management of LMOs.

As to the RA basic concept,

Receiving environment is one of major factors for RA.  Consideration on Transgene x Host x Environment is the core concept.
Adaptation and invasiveness are some of contexts on environment and both textual and experimental assessments of the host species are required in the receiving environment with scientific basis.

Especially, if the host species is totally new to the receiving environment, at first the host should be carefully examined.  While it is certain on any introduction of a new species to the environment, this should be carefully examined and emphasized to make sure the ecological influence.

As on many of agriculture and forest species, when the LMOs are introduced into the origin of the diversity of the species, as already discussed in many fora, further precaution is made.  There shall be a more review such as OECD consensus document to add up more species with the aspects such as tree species.

kind regards,