20 I EUROPEAN SEED I EUROPEAN-SEED.COM HARMONISED GOVERNMENT POLICIES Maintaining and increasing agricultural production is a global concern so there is clearly a need for harmonised government policies. Harmonisation facilitates the trade and movement of seed and helps create a level playing field. Consistent science-based policy means farmers and consumers around the world can enjoy the benefits of products developed through the latest breeding methods.8 So far there are only a few precedents of governmental decisions regarding whether a crop obtained by a newer breeding method is under regulation usually applied specifically for GMOs.9 Argentina is the first country that has adopted its GM regulatory framework to be applicable to newer breeding techniques. In the United States there are ongoing discussions for a revised regulatory framework10 although the first products from newer breeding methods have Crop Breeding Method Description Publication Wheat TALEN Wheat powdery mildew resistance all six Mlo alleles have been modified simultaneously resulting in deletions in the coding sequence of Mlo. Wang Y.P. et al. 2014 Simultaneous editing of three homoeoalleles in hexaploid bread wheat confers heritable resistance to pow- dery mildew. Nat. Biotechnol. 32 947951 Rice TALEN Generating bacterial leaf blight resistance in rice using TALENs. Bacterial leaf blight caused by Xanthomonas oryzae is the most widespread pathogen in rice. Li T. et al. 2012 High-efficiency TALEN- based gene editing produces disease-resistant rice. Nat. Biotechnol. 30 390392 Soy TALEN TALENs were used to generate soybean plants in which the fatty acid profile was dramatically changed to avoid undesired polyunsaturated fatty acids by induction of ho- mozygous mutations in two different FAD coding genes. Haun W. et al. 2014 Improved soybean oil quality by targeted mutagenesis of the fatty acid desaturase 2 gene family. Plant Biotech- nol. J. 12 934940 Potato TALEN Using TALENs in a commercial tetraploid potato variety the accumulation of reducing sugars during cold storage was switched off by knocking out all four alleles of the potato vacuolar invertase gene Vlnv. Tubers from full Vlnv-knockout plants had undetectable levels of reducing sugars and processed chips contained reduced levels of acrylamide. Clasen B.M. et al. 2015 Improving cold storage and processing traits in potato through targeted gene knockout. Plant Biotechnol. J. Published online April 72015. Maize ODM Maize plants tolerant to imidazolinone herbicides have been engineered through targeted modification of the endogenous acetohydroxyacid synthase AHAS gene. Zhu T. et al. 2000 Engineering herbi- cide-resistant maize using chimeric RNA DNA oligonucleotides. Nat. Biotechnol. 18555558 Apple Accelerated breeding with early flowering genes Induced early flowering has been applied to fruit trees to accelerate breeding. Fruit species such as apple Malus x domestica and plum Prunus domestica have a long generation time 5-7years. As a consequence fruit breeding takes a long time especially when novel traits from related wild species are introgressed and multiple generations are required to remove genetically-linked undesired characteristics from the wild fruit species. By overexpression of the BpMADS4 gene from silver birch Betula pendula early flowering was successfully intro- duced resulting in flower induction in seedlings within the first year. These early flowering transgenic lines were then used for a fast breeding program in which disease resistance genes were stacked. In the end the transgenic early flowering trait was crossed out resulting in a non- GM end product. Flachowsky H. et al. 2011 Application of a high-speed breeding technology to apple Malus x domestica based on transgenic early flowering plants and marker-assisted selection. New Phytol. 192 364377 Rapeseed Barley CRISPR CRISPR was used to make targeted changes or edits to specific genes in two UK crops a broccoli-like brassica and barley. In barley the gene that was edited is thought to affect grain dormancy this is an important agricultural trait. In brassica the edited gene affected the ease with which the seed pods shattered. Lawrenson T. et al. 2015 Induction of targeted heritable mutations in barley and Brassica oleracea using RNA-guided Cas9 nuclease. Genome Biology 16258 Arabidopsis CRISPR The same mutant produced five times but which ones are within the scope of the European GMO legislation A. The radiation mutant B. The chemically induced mutant C. The T-DNA mutant D. E. The modern genome edited mutan The Arabidopsis thaliana PsbS mutant httpwww.upsc.sedocumentsNews Arabidopsis_PsbS_mutants.pdf Table 2. Examples of crops and traits produced by newer breeding methods with scientific references. already been cleared by the United States Department of Agriculture as being non-GM.11 In Canada the whole regulatory system is established on a product- based approach whereby the process of creating a new plant is more or less irrelevant to its regulatory status. These few examples show the diversity of regulatory approaches worldwide. However inconsistent policies make research collaborations difficult and have a negative impact on commercial seed and commodity trade in agricultural products. From a competitive point of view inconsistent policies will have differential negative impact on plant breeding innovation across countries because access to genetic diversity which is a prerequisite for successful breeding will be restricted by regulation. In the end the range of new varieties for farmers and new products for consumers will be determined by different regulatory burdens.