EUROPEAN-SEED.COM I EUROPEAN SEED I 69 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 UNITED KINGDOM - INTERNATIONAL COL- LABORATION ON CROP PROTECTION AHDB crop protection staff working in collaboration with the EU Minor Uses Coordination Facility have benefited from sharing residue data and exploring an international crop protection registra- tion database to identify approvals across Europe and further afield. Specialists in pesticide regulation, Vivian Powell and Bolette Palle Neve represent British growers in two expert groups for fruit and vegetables and orna- mentals made up of representatives from each EU member state. “AHDB has undertaken a number of projects supported by the coordination facility to pinpoint new treatments for speciality crops including residue data to support the use of Tracer (spinosad) on bush and cane fruit and resulted in an EAMU for the control of spotted wing drosophila and thrips” said Bolette. Addressing the many gaps in crop protection in the UK, AHDB can expand its search for solutions through the Homologa database, an international crop protection registration database which can draw on approvals for plant protec- tion products wider than just Europe. The coordination facility is continu- ally looking to involve growers in minor uses work to ensure any results have a commercial return. The collaboration extends across the Atlantic, liaising with expertise from the IR-4 programme in the USA, the Canadian minor use pesticides programme and the work in Brazil on minor uses. This October, will see the third Global Minor Use Summit in Montreal, Canada to help develop new strategies for minor use programmes and stream- line approval requirements in order to reduce costs for approvals on products for speciality crops. The possibility of regulatory authori- ties agreeing common data standards gen- erated in one country can be acceptable in another would ensure more adequate use of resources. More details can be found on the website at INTERNATIONAL US FOOD AND DRUG ADMINISTRATION COMPLETES SAFETY REVIEW OF VERDE- CA’S HB4 STRESS-TOLERANT SOYBEANS Arcadia Biosciences, Inc. and Bioceres S.A. announced their joint venture, Verdeca, received notification that the U.S. Food and Drug Administration (FDA) has completed its full review of the company’s safety eval- uation for HB4 soybeans. The FDA’s notice to Verdeca allows products derived from HB4 soybeans to be used commercially in human food and animal feed. This is a major milestone in the development of commercial soybean seed products based on the HB4 stress tolerance trait. The FDA uses its Biotechnology Notice process to review and assess safety data provided by companies developing new plant varieties using advanced breed- ing technologies. The data provided to the FDA is consistent with international regu- latory requirements for genetically modi- fied crops and will be used by Verdeca and its global partners for future regulatory submissions. Verdeca’s HB4 soybeans have under- gone extensive testing, including mul- ti-location field trials in Argentina and the United States and multiple regulatory field trials. The results of these trials demonstrate that the HB4 trait can pro- vide yield advantages under stress condi- tions – including drought and low-water conditions – found in several soybean pro- duction areas. “The HB4 gene holds great prom- ise for bringing better yield stability to agriculture in areas that experience chronic water stress problems,” said Raj Ketkar, president and CEO of Arcadia Biosciences. “Our combined efforts aim to create significant value for soybean growers by increasing the productivity and sustainability of this important pro- tein crop in the face of global climate challenges.” “The FDA is one of the most prestig- ious regulatory agencies in the world and its opinions are of reference to regulators everywhere,” said Federico Trucco, CEO of Bioceres. “In a way, this FDA clearance testifies to the quality standards imple- mentented in HB4 product development and safety evaluations. We hope this deci- sion will help expedite international reg- ulatory clearences for HB4 soybeans, and bring us closer to the much anticipated launch of this unique technology.” Completion of the FDA’s review is another key regulatory achievement in the approval process for Verdeca’s HB4 drought stress tolerance trait. SEED INSTITUTE TO ENHANCE REGULATIONS The Seed Control and Certification Institute (SCCI) in Zambia will enhance regulation among seed producers to ensure the country has a sustainable system, which will be easily accessed and afforda- ble among the farming communities. SCCI stresses the need for farmers to access high-quality seeds with a wide- range of crops and varieties to increase pro- ductivity and food security in the country. SCCI senior seeds officer Mudenda Sikwangala has since cautioned farm- ers of uncertified agro-dealers who are taking advantage of the farming commu- nities by selling illegal seeds and prod- ucts at reduced prices.