EUROPEAN-SEED.COM I EUROPEAN SEED I 37 REGULATORY KEEPING YOU INFORMED OF LEGISLATIVE AND REGULATORY CHANGES IN EUROPE AND ABROAD — FROM LAWSUITS TO APPROVALS TO OTHER REGULATORY ISSUES AFFECTING YOUR BUSINESS. NATIONAL EUROPEAN COURT SUGGESTS RELAXED GENE-EDITING RULES Crops and drugs created using pow- erful gene-editing techniques such as CRISPR–Cas9 might not need to be regulated by the strict European Union rules that govern genetically modified organisms (GMOs), according to a formal opinion from an advocate general in the European Court of Justice. European scientists have cautiously welcomed the carefully worded document, published on 18 January. They would like to use precise gene editing, which allows tiny changes to be made to a genome in a simple and highly controlled manner, to create har- dier plant species or to improve medical treatments. But legal uncertainty about existing rules has hindered progress in Europe, say researchers. UKRAINE RECEIVES AUTHORIZATION TO SUPPLY BEET SEEDS TO THE EU Ukraine received an authorization to par- ticipate fully in the international trade of sugar beet and fodder seeds. This decision was announced on 31 January at an annual meeting of the member countries of the Organization for Economic Cooperation and Development (OECD) in Paris, reports the press ser- vice of the Ministry of Agrarian Policy and Food of Ukraine. “To date, Ukraine has participated in four Seed Systems, which are officially recognized as a tool for certification and simplification of international seed trade. In particular, it deals with systems such as cereals, maize, sorghum and fibers (cruciferous and other oleaginous). Now the Systems list added forage and sugar beet. The seeds produced and processed according to the Systems are accom- panied by labels and certificates of the OECD,” says the Ministry. According to the Ministry of Agrarian Policy, the decision to expand Ukraine's participation in the OECD Seed Systems will open the way for the seeds of sugar beet to the world market, will allow to improve the varietal purity of the seed material, will guarantee the growth of the performance of the main agricultural plants. According to the decision of the OECD Council on 16 November 2009, Ukraine joined the OECD Grain, Corn, Sorghum Seed Systems and has the possi- bility to participate in international seed trade using OECD labels. INTERNATIONAL EPA RELEASES GUIDANCE ON REDUCED RESIDUE CHEMISTRY DATA REQUIRE- MENTS FOR SEED TREATMENT USES On 1 February, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help man- ufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced. In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treat- ment field-trial residue data and has reviewed multiple field-trial datasets that indicated that there was the potential to reduce the number of field trials required to support the registration of seed-treat- ment uses.” EPA states that to evaluate this hypothesis, the HED Chemistry Science Advisory Council (ChemSAC), in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), in accordance with the July 11, 2017, Joint Canada/United States Field Trial Requirements “performed a retrospective analysis of all seed-treatment residue data that have been submitted to EPA/PMRA and has developed a tiered approach for determining if current crop-specific field trial data requirements are required to support new seed-treatment uses, or if a reduction in the number of required field trials is appropriate.” EPA’s announce- ment states that “the analysis showed that the data required to support regis- tration could be substantially reduced and still be protective of human health.” GENETIC MODIFICATION LAWS SET FOR SHAKE-UP Australia is set to reform how it regu- lates new genetic engineering techniques which experts say will help to dramat- ically speed up health and agriculture research. The changes will enable agri- cultural scientists to breed higher yield- ing crops faster and cheaper, or ones resistant to drought and disease. Australia’s gene technology regulator Raj Bhula has proposed reducing regu- lations around gene editing techniques such as CRISPR, following a 12-month technical review into the current regu- lations. The most radical change put for- ward by the regulator is that some of the more efficient and newer genetic technol- ogies, known as gene editing, would not be considered “genetic modification”. “With gene editing you don’t always have to use genetic material from another organism, it is just editing the [existing] material within the organism,” Dr Bhula said. “All of our regulatory frameworks and laws have been established based on people putting unrelated genetic material into another organism. Whereas this pro- cess is just manipulation within the organ- ism and not introducing anything foreign.” BASF protects fungicide intellectual property rights and innovation invest- ments, challenges unauthorized use of pyraclostrobin technologies by Willowood LLC.