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Genetic engineering and protected areas

1000 m is the radius within which a more detailed assessment is needed.’

In the public debate, genetic engineering and nature conservation appear incompatible. The main focus is on the potential damage to protected species from pollen produced by genetically modified plants. Nature conservation organisations would therefore like to see the introduction of minimum separation distances between GM plants and protected areas. The German Society for Nature Conservation (NABU), for instance, is calling for a separation distance of 1000 metres. So far though there is no legally binding minimum distance. There is, however, a whole raft of unresolved legal issues. GMO Safety spoke to Ulrike Middelhoff of the Federal Office of Consumer Protection and Food Safety (BVL).

Ulrike Middelhoff, an expert in the Deliberate Release and Placing on the Market unit of the Genetic Engineering department of the Federal Office of Consumer Protection and Food Safety (BVL)

Natura 2000 is a network of special protected areas within the European Union. It covers the special areas of conservation under the Habitats Directive and special protection areas under the Birds Directive. Natura 2000 areas are areas of importance to the Community that have been designated by member states of the European Union.The Habitats Directive is a nature conservation directive of the European Union on the conservation of natural habitats and species diversity. It was adopted in 1992.

GMO Safety: In 2005, in the course of amending the German Genetic Engineering Act, a new paragraph (paragraph 34a) was added to paragraph 34 of the German Federal Nature Conservation Act. The new paragraph states that in the event of GM plants being released or cultivated in or near Natura 2000 areas, assessments must be carried out to check whether the protected area will be significantly affected as a result of the experimental release or cultivation. Who is responsible for carrying out the assessment?

Ulrike Middelhoff: This is the impact assessment prescribed under European legislation. The assessment is intended to ensure that Natura 2000 areas are not affected. It covers activities like building projects and – as the Federal Nature Conservation Act now makes clear – plans to release or cultivate GMOs. For all projects that require authorisation, responsibility for the impact assessment lies with the relevant authorising body. Since GMO releases require approval from the Federal Office of Consumer Protection and Food Safety (BVL), the BVL also conducts the impact assessment for planned GMO releases.

GMO Safety: What happens in practice if the authorising body establishes that there are plans to carry out GMO releases in the immediate vicinity of a Natura 2000 area?

Ulrike Middelhoff: In practice what happens now is that applicants check for themselves whether a planned release location is in or near a Natura 2000 area. The relevant distance in this case is usually 1000 metres. If the release location is less than this distance from a protected area, information about the protected area has to be submitted along with the release application.

When inspecting the documents, the BVL will first check whether the project could in principle have an impact on at least one of the conservation objectives of the protected area. The actual impact assessment will take place only if such a possibility exists. The first assessment stage usually requires additional information, which the BVL obtains from other bodies, where possible. The aim is to check first whether a planned release could have a significant adverse effect on the Natura 2000 area, either on its own or in combination with other projects. To do this the BVL uses available information to assess potential impacts on all relevant conservation objectives.

If it is not possible to rule out the possibility of a significant impact with certainty at the preliminary stage, the BVL has to carry out a full assessment. This has not yet been necessary for any of the GMO release applications submitted to the BVL.

If the BVL came to the conclusion in an impact assessment that a protected area, or the elements required to conserve it, could suffer significantly as a result of a planned release, the application could not be approved.

GMO Safety: The Federal Agency for Nature Conservation (BfN) offers a map service for GMO releases. It gives a buffer zone of 1000 metres. What does the separation distance mean and where does it come from?

Ulrike Middelhoff: The BVL encouraged the setting-up of a map service so that applicants can plan their release trials better. Using the map service offered by the BfN they can check for themselves easily whether a planned release location is in or near a Natura 2000 area. 1000 metres is the radius within which a more detailed assessment is needed. The separation distance is based on the supposition that the impact radius of most of the GMOs released to date lies within the 1000-metre zone.

GMO Safety: The only genetically modified plant currently cultivated in Europe, including Germany, is Bt maize MON810. What does the impact assessment entail for the cultivation of a GMO?

Ulrike Middelhoff: The procedure for GMO cultivation differs from that used for experimental releases because there is already a Europe-wide authorisation in place for placing the GMO on the market. If such projects are subjected to an impact assessment, the assessment is carried out by the authorities responsible for the protected area in question. This means that in Germany it is the regions that are responsible for the assessment. However, it is currently not clear whether an impact assessment is permitted at all for the planned cultivation of a GMO if the authorisation for placing the GMO on the market does not contain any stipulations for the protection of special ecosystems. The European legal norms for the areas of genetic engineering and nature protection may not have been sufficiently well coordinated at this level. The European Commission has yet to give a final opinion on this issue.

In this situation the regions have a choice: if they don’t assess, they could run the risk of EU infringement proceedings. If they do assess, they could risk losing a case brought by a farmer. Evidently, the majority of the authorities in question are deciding to go ahead and assess. We even know the assessment radius used by two of the German regions. This is not very different (Brandenburg 800 m, Saxony 1000 m) from the standard assessment radius for experimental releases mentioned earlier.

The authorities that have decided to carry out impact assessments for GMO cultivation plans are, in several respects, entering uncharted territory. Since the assessments are not an integral part of an authorisation procedure, the authorities have to develop a separate procedure. The expert assessment requires familiarisation with issues concerning the impacts of GMO cultivation on protected organisms and habitats. Nevertheless, it can be assumed that the expert decision criteria are no different from those used as a basis for assessing experimental releases.

GMO Safety: What are the farmer’s duties if he wants to grow Bt maize in or near protected areas? Does he have to ask the regional nature conservation authority (Untere Naturschutzbehörde) whether cultivation might touch on nature conservation issues?

Ulrike Middelhoff: If the authorisation for placing a GMO on the market contains stipulations for the protection of special ecosystems, a farmer must, in accordance with paragraph 5 of the German regulation on good farming practice (GenTPflEV), check with the relevant regional authority whether the conditions apply in his case. So far, though, there has been no authorisation to place on the market that includes such special conditions, which means that at the moment farmers are not obliged to take any action under the GenTPflEV regulation.

However, a farmer must in all cases inform the BVL of his cultivation plans three months before sowing (site register, § 16a German Genetic Engineering Act). For Natura 2000 areas, the view is that notification sent to the BVL’s site register simultaneously acts as an announcement under the German Nature Conservation Act (BNatSchG), which may then, if the case arises, trigger an impact assessment, despite the fact that no information about Natura 2000 areas is included in the site register notification. Since the BVL makes the information contained in the notifications available to the regional authorities, it is a matter for the regional authorities to decide whether they treat the site register notification as an announcement in terms of the BnatSchG.

GMO Safety: There are other types of protected area apart from the Natura 2000 areas and, of course, the protection of species. Are there different conservation objectives that need to be taken into account here too? What are the responsibilities of the different authorities?

Ulrike Middelhoff: An application for authorisation of a planned release trial must contain various details about the planned release site. As well as the Natura 2000 areas already mentioned, the application requires information about the presence of strictly protected species, the proximity to legally protected biotopes and proximity to protected areas in the categories nature reserves, national parks and biosphere reserves. As part of the authorisation procedure, any impacts on the environment as a result of the planned release trial are assessed. The BVL is responsible for assessing GM-specific risks. These are risks posed by the GMO itself. Non-GM-specific risks are e.g. measures planned by the applicant in connection with the project, such as the erection of fences or plans to plough up grassland. Assessment of these measures is the responsibility of the local authorities.

GMO Safety: Thank you for talking to us.