Faster and cheaper approval needed for safe, genetically modified crops without foreign genes (cisgenic crops)Approval of GM crops in Europe is very time consuming and expensive
Genetically modified (GM) crops that are approved for cultivation or use in Europe contain foreign genes from micro-organisms and/or genes that are designed by mankind. These genes have been used for selection of GM cells during the process of genetic modification, or these genes are introduced for its target traits, such as resistance to insects or herbicides. In Europe there has been serious opposition to the introduction of genes from micro-organisms into crops. This has led to a very stringent approval policy in Europe, described in Directive 2001/18/EC and Regulation (EC) 1829/2003.
The approval procedure for GM crops for cultivation and marketing in Europe is generally too expensive and time consuming for small and medium enterprises (SMEs) and for public institutions (universities and research centres). Consequently, only a few giant agro-chemical companies have submitted dossiers to the EFSA for approval of plants in Europe. Because of the cost and complexity of the present European regulation,
only a few GM commodity crops have been released in Europe focussed on crops with large acreages and with a high potential return, but the regulation is
still a very serious barrier to innovation in GM fruit varieties for e.g. health benefits,
as mostly SMEs or public institutions create these varieties. This reduces the agro-biodiversity of approved crops considerably. It impedes seriously the approval of safe GM speciality crops with high public (environmental and consumer) benefit but lower potential return to the developer. The limited genetic diversity of GM crops may lead to break down of pest resistance, on huge areas, as happened earlier to hybrid corn in the USA. This is not the aim of the European Directive on GMOs.
Recent developments
In the mean time, developments in plant biotechnology have addressed several objections to GM plants. - Methods have been developed for genetic modification yielding plants without foreign selection genes;
- The knowledge of plant genes and genomics has increased exponentially. A rapidly increasing number of genes from crops have been isolated and functionally analyzed. This knowledge is boosting further by the large-scale DNA sequencing of whole plant genomes. The isolated, characterized genes can be inserted directly into modern cultivars by means of genetic transformation. We name these natural genes, which can be introduced also by means of conventional breeding into the crop, ‘cisgenes’. Genes that cannot be used in conventional breeding are called ‘transgenes’. The process of insertion of a cisgene into a crop is called ‘cisgenesis’. An important advantage of cisgenesis compared to conventional breeding is that only desired, well-characterized genes are inserted into the cultivars, without co-introducing unwanted or unknown genes. This may lead to more efficient, faster and safer plant breeding. Cisgenesis is particularly useful for the introgression of genes from wild relatives for durable resistance to pests and diseases, allowing a significant reduction of pesticide usage.
Cisgenesis is at least as safe as conventional breeding and mutation breeding
Cisgenesis is currently applied for resistance to the devastating disease caused by Phytophthora infestans in potato. Control of this disease currently requires an unacceptably high input of fungicides. Conventional breeding for durable resistance is very time consuming and also causes unwanted introgression of genes for toxic compounds, such as glyco-alkaloids from wild potato plants. Removal of these damaging traits by means of repeated backcrossing makes conventional breeding a very long process for several crops. In case of cisgenesis, only the resistance genes are inserted into the cultivars, without the unwanted genes for toxicity, or other unwanted traits. Because of this, cisgenesis is usually safer than conventional breeding or mutation breeding. It adds a well-defined trait from classical breeding to a plant variety with history of safe use, without introducing unknown or unwanted genes from wild related plants.
Similar national efforts are underway in the apple crop for adding resistance to apple scab to high quality varieties. Fruit species are vegetatively propagated, therefore improvement of a
precise trait (such as resistance) without modifying the genetic
background of already successful varieties is a very important
objective for these crops.
If cisgenic crops are cultivated in fields, pollen from these crops may spread to and fertilize wild relatives in the neighbouring flora. Cisgenesis overcomes these biosafety issues because the cisgenes have been taken from wild relatives, and have already been present in the flora for a long time. Moreover these genes may have been used already in conventional breeding. Therefore, co-existence of cisgenic crops and non-gm crops is neither an issue, as no flow of foreign genes occurs from the cisgenic crop to the non-gm crop.
The insertion site of the cisgene into the plant genome is unpredictable, just like in conventional induced translocation breeding. Therefore, several cisgenic plants are made, and the best performing plants selected, again, just like in conventional breeding.
The European GMO Regulation is a serious obstacle
The current European regulation for GMOs is based on transgenes. The regulation does not distinguish cisgenic plants from transgenic plants. Consequently, approval of cisgenic crops is too time-consuming and too expensive for SMEs and public institutions. Moreover particular safety/risk information requests needed for the approval of transgenes GM plants, are obsolete to cisgenesis.
Proposal
In view of the inherent safety of cisgenic plants, we propose faster and cheaper approval of cisgenic crops. This can be achieved by adding Cisgenesis to the list of GM technologies that are exempted from the European GMO Regulation (see Annex 1B in Directive 2001/18). The cisgenic crops contain genes only that can be used in classical breeding too. Cisgenesis is as safe as or even safer than classical breeding. It will lead to a more efficient improvement of crops, a strong reduction of fungicide usage, and higher food quality. Faster and cheaper approval will allow also SMEs (Small and Medium sized Enterprises) and public institutions to use cisgenesis for a variety of crops, therefore leading to a wider agro-biodiversity in Europe and thus to a more sustainable agriculture.
Literature
- Schouten, H.J., Krens, F.A., Jacobsen, E., 2006. Do cisgenic plants warrant less stringent oversight? Nature Biotechnology 24: 753.
- Schouten, H.J., Krens, F.A., Jacobsen, E., 2006. Cisgenic plants are similar to traditionally bred plants. EMBO Reports 7: 750-753.
- Jacobsen, E., Schouten, H.J., 2007. Cisgenesis strongly improves introgression breeding and induced translocation breeding of plants. Trends In Biotechnology 25: 219-223.
- Rommens, C. et al., 2007. The intragenic approach as a new extension to traditional plant breeding. Trends in Plant Science 12: 397-403.
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