Biopesticides Biofertilisers Biostimulants

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1 DIE AKADEMIE FRESENIUS Where Experts Meet! International Fresenius BIOCONTROL Conference Biopesticides Biofertilisers Biostimulants 5 and 6 June 2018 in Mainz/Germany Highlights Regulatory Developments Registering biopesticides in Europe, experiences and a way forward Biostimulants: Regulatory framework and regulatory strategy ECHA s efforts to integrate biological biocides in the framework of the BPR Competent Authority s view on biological biocides Virus use in biocontrol: Issues, points of interest, regulatory framework International Developments Approval and distribution of biopesticides in the USA The OECD programme on biopesticides: Available tools and challenges Environmental Risk Assessment Effects of microbial pest control agents on soil organisms Risk assessment of secondary metabolites Data requirements and environmental risk assessment of microbial pest control agents The potential for immune activation and possible consequences for bees upon exposure to microbial pest control agents Human Health Risk Assessment Regulatory experience with evaluating human health related issues of biopesticides Challenges and solutions for generating testing for human health related issues Updated Programme The Experts Gertie H. P. Arts Wageningen University & Research Centre Saskia Bosman-Hoefakker Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) Frank Dieterich German Federal Institute for Occupational Safety and Health (BAuA) Matthias von Erffa Bayer Crop Science Biologics Rüdiger Hauschild GAB Consulting / Member of IBMA Microbial Biocontrol Agents (MBCA) Professional Group Ton van Huygevoort Charles River Laboratories Ben Jones Applied Insect Science (APIS) Philip Kessler Andermatt Biocontrol Jürgen Kohl Wageningen University & Research Centre Marta López Redebel Regulatory Affairs Keith Pitts Marrone Bio Innovations Outi Priha European Chemicals Agency (ECHA) Magdalini Sachana Organisation for Economic Co-operation and Development (OECD) Jacqueline Scheepmaker Dutch National Institute for Public Health and the Environment (RIVM) Anne Steenbergh Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) Ingvar Sundh Swedish University of Agricultural Sciences SLU Mark Whittaker Applied Insect Science (APIS)

2 The Programme Get-Together on Monday, 4 June 2018 Will you arrive on Monday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere. Tuesday, 5 June Registration and coffee 9.00 Welcome address by the organisers and introduction by the Chair Mark Whittaker, Applied Insect Sciences (APIS), United Kingdom Regulatory Developments 9.10 Issues and points of interest: The current regulatory framework for Biopesticides from an Industry point of view Matthias von Erffa, Bayer Crop Science, Germany 9.40 Registering biopesticides in Europe, experiences and a way forward How did the interpretation of data requirements develop during the past years? Are data requirements related to the actual risks? How can requirements be amended? Rüdiger Hauschild, GAB Consulting/Member of IBMA Microbial Biocontrol Agents (MBCA) Professional Group, Germany Biocontrol from development to registration Jürgen Kohl, Wageningen University & Research Centre, The Netherlands Panel discussion Coffee break Biostimulants: Regulatory framework and regulatory strategy Regulatory approach among the member states national provisions Application of the Mutual Recognition Regulation to fertiliser products Regulatory strategies to place biostimulants and new fertiliser products on the market Marta López, Redebel Regulatory Affairs, Belgium Regulatory frameworks and approval processes for microbial control agents in the EU: A microbiologist s perspective When is biological control regulated? Why such a lengthy, complicated process for microbial products? Major hurdles. Current developments and trends. Ingvar Sundh, Swedish University of Agricultural Sciences (SLU), Sweden Virus use in biocontrol: Issues, points of interest, regulatory framework Philip Kessler, Andermatt Biocontrol, Switzerland Panel discussion Lunch ECHA s efforts to integrate biological biocides in the framework of the BPR Outi Priha, European Chemicals Agency (ECHA), Finland Competent authority view on biological biocides Identification of microbial biocides Other specific issues of microbial biocides in approval and application Frank Dieterich, Federal Institute for Occupational Safety and Health (BAuA), Germany Panel discussion Coffee break International Developments Approval and distribution of biopesticides in the USA Keith Pitts, Marrone Bio Innovations, United States The OECD programme on biopesticides: Available tools and challenges An introduction to the OECD programme on biopesticides Available OECD tools for the safety assessment of biopesticides Magdalini Sachana, Organisation for Economic Co-operation and Development (OECD), France Panel discussion End of the first conference day Departure time for the evening event

3 As always you are most welcome to attend our evening event, which will take us to the local Cistercian monastery named Eberbach. We will enjoy a short tour of the venue, which has once served as the set for the well know movie The name of the Rose. Afterwards we will enjoy a dinner and have time to continue the days interesting conversations in a relaxed atmosphere. Don t miss out on this opportunity! Wednesday, 6 June Welcome address by the Chair Mark Whittaker Environmental Risk Assessment 9.10 Risk assessment of secondary metabolites Some complicating issues Possible solutions Jacqueline Scheepmaker, National Institute for Public Health and the Environment (RIVM), The Netherlands 9.40 Data requirements and environmental risk assessment of microbial pest control agents The relevance of the data requirements Utilising data to address the risk resulting from the use of the microorganism Anne Steenbergh, Dutch Board for the Authorisation of Plant Protection Products (Ctgb), The Netherlands The potential for immune activation and possible consequences for bees upon exposure to microbial pest control agents Exposing insects to microbes can activate subclinical responses, potentially leading to colony level effects Example: antimicrobial peptide response in bumblebees and honey bees Need for more differentiated laboratory trials and higher tier field trials Ben Jones, Applied Insect Science (APIS), United Kingdom Panel discussion Coffee Break Human Health Risk Assessment Regulatory experience with evaluating human health related issues of biopesticides Qualitative risk assessment Risk assessment of relevant metabolites Low risk and antibiotics testing Saskia Bosman-Hoefakker, Board for the Authorisation of Plant Protection Products (Ctgb), The Netherlands Research perspective: Challenges and solutions for in-vivo testing of biopesticides Prerequisites for animal testing Clearance and infectivity Biological versus pathogenic response Ton van Huygevoort, Charles River Laboratories, The Netherlands Panel discussion Lunch and end of the conference Short coffee break Effects of biopesticides on non-target organisms in soil Effects on soil organisms are transient and non-persistent Recovery of effects is observed Effects last from several weeks to several months The current regulation for chemical pesticides is not suitable for the risk assessment of biopesticides Gertie H. P. Arts, Wageningen University and Research Centre Information available online at:

4 The Experts Gertie H. P. Arts holds a PhD in natural sciences and works at Wageningen University and Research (Wageningen Environmental Sciences) as a Senior Ecologist and Ecotoxicologist in the environmental risk assessment team. She is involved in ecological, ecotoxicological studies, and risk assessment for organic and other contaminants, especially risk assessment for aquatic macrophytes and plants as well as plant ecology and ecotoxicology. Saskia Bosman-Hoefakker is a Scientific Assessor for Human Toxicology/Toxicologist at the Dutch Ctgb. She is responsible for national authorisations and evaluations of biopesticides and biological biocides also under the EU review process. She participates in the ad hoc BPC WG on microorganisms for biocides and the Biopesticides WG for PPPs. Frank Dieterich is a Biologist and has been working as a Scientist for the German Federal Institute for Occupational Safety and Health (BAuA) since Priorly he has been employed as a Scientist for microbiology within the oil and gas industry. Matthias von Erffa (Dipl. agr. oec.) has been working in biocontrol since Since 2013 he has been working in regulatory affairs for biocontrol agents for Bayer. Matthias is an active member of IBMA Germany/Austria and a member of IBMA global s Microbials Professional Group; he has also been a member of their steering committee since Rüdiger Hauschild has a background in molecular plant physiology and phytopathology and has worked within the field of biocontrol research for several years. He is the Director and Head of the Biopesticides Department at GAB Consulting and has been working on registration of biocontrol agents for more than 12 years. He is also a member of the Steering Committee of the Professional Group Microbials within the IBMA. Ton van Huygevoort has been a Study Director for General Toxicity at Charles River Laboratories Den Bosch since Between 1985 and 1997 he worked as Research Technician at the Department of Pharmacology at TNO Rijswijk. Ben Jones is a Study Director at Applied Insect Science (APIS). His research investigates the impacts of environmental stressors on honey bee health. Using laboratory and field based experimental systems he investigates the effects of biopesticides on clinical and sub clinical responses of honey bees. Philip Kessler has been working for Andermatt Biocontrol since In different roles he has been responsible for the registration of biopesticides, as well as the market development in Africa, Asia and Australia. From 2011 to 2016 he was the Head of Regulatory Affairs and in 2016 he was assigned as Director International Market Development. He is active in the Professional Group for Microbials within IBMA and has been a member of their Steering Committee since Jürgen Kohl is a Senior Plant Pathologist with long-year experience in the development of biological control of fungal plant pathogens. He is currently a Senior Researcher at Wageningen University and is also the Research Coordinator of the EU project BIOCOMES. Marta López has been working as Regulatory Affairs Specialist at Redebel Regulatory Affairs since She provides regulatory advice and assistance for placing on the EU market plant protection products, fertilisers and biostimulant products. Previously, she worked at Grupo Tragsa, collaborating with the Spanish Ministry of Agriculture, Food and Environment. She conducted risk assessments for the authorisation and maintenance of the Official Register of Pesticides in Spain. Keith Pitts is the Chief Sustainability Officer at Marrone Bio Innovations and is responsible for Senior Vice President, Regulatory and Government Affairs. He has priorly been the Vice President-Regulatory and Government Affairs at Marrone and has significant substantive expertise in all aspects of agriculture, food, conservation, and biotechnology policy. Outi Priha joined the European Chemicals Agency (ECHA) in March 2016, and is chairing the Biocidal Products Committee Ad hoc Working Group on Micro-organisms. She has a PhD in environmental microbiology. Before she has worked as a Scientist at VTT Technical Research Centre of Finland for 14 years, where her main research activity was on detection and control of biofouling in close co-operation with the industry. Magdalini Sachana is a Policy Analyst within the Health and Safety Division of the OECD s Environmental Directorate. She manages the development and implementation of policies in the field of chemical safety and contributes to pesticide, test guidelines and hazard assessment programmes. She also manages the OECD programme on biopesticides. Jacqueline Scheepmaker has been working at the Dutch National Institute for Public Health and the Environment (RIVM) for 17 years. Her work priority is the methodology development of the risk assessment of microbial pest control agents such as persistence of inoculum in the soil and secondary metabolites. Anne Steenbergh is a Microbial Ecologist employed at Ctgb Netherlands as an Assessor for environmental fate and behaviour. As part of the Ctgb GreenTEAM she focuses on the risk assessment of biopesticides. Ingvar Sundh s research at the Swedish University of Agricultural Sciences (SLU) focuses on safety assessment of microorganisms used in beneficial applications, particularly biocontrol of pests and diseases. He also has a strong interest in regulatory policy issues and supports national and international authorities and organisations in the area. He is currently a member of EFSA s Qualified Presumption of Safety (QPS) Working Group and the PPR Panel. Mark Whittaker has a PhD in entomology and is an established expert on the registration of biopesticides. He is the Managing Director of APIS, a specialist contract research lab for microbial safety testing.

5 About Who do you meet? Groups that should take part: Managing directors, boards of directors, managers, consultants and scientists in the fields of: Biological control for agricultural use Production/distribution of biological/microbial pesticides and biocides Research & development Risk assessment Toxicology Ecotoxicology Registration Sectors that should take part: Agrochemical industry Biocontrol industry Research institutes Authorities Professional associations Contract laboratories/ consultancies Trade Exhibition Our conference provides you with the opportunity of presenting your company in a trade display. Present your products and services and reach out to your specific target groups. We would be happy to provide you with information on all the various options available from displaying product information to an exhibition stand with no further obligation on your part. Use the attached fax reply sheet to request our information material. Or simply call us. We would be more than pleased to assist you personally. Semsigül Yalcin phone: syalcin@akademie-fresenius.de 18 to 19 June 2018 in Mainz/Germany 20 th International Fresenius AGRO Conference "Behaviour of Pesticides in Air, Soil and Water" Please order Information now! info@akademie-fresenius.com The Organiser For over 20 years, Akademie Fresenius has been your partner for practice-orientated training on all the latest topics surrounding the safety and quality of food, consumer goods and chemical products along the whole production chain. Our portfolio not only includes international conferences but also offers national trade meetings, intensive practical seminars and training in small work groups. Our events are designed to promote an active exchange amongst our participants and offer the perfect platform for bringing the industry, the scientific sector, the authorities and the consulting field together. Excellent service, all-inclusive. Our wide-ranging advanced training opportunities contribute to giving our customers the competitive edge in all quality assurance, risk assessment, legal, production and technical questions. Akademie Fresenius is a joint venture between Cognos, one of the largest private and independent education groups in Germany, and SGS Institut Fresenius, one of the leading German providers of chemical laboratory analysis. You can find details on upcoming and new events at Do you have any questions? Programme and conceptual design Anne Möller phone: amoeller@akademie-fresenius.de Organisation and participant management Danielle Sörries phone: dsoerries@akademie-fresenius.de

6 Registration By web By By fax Hotline Die Akademie Fresenius GmbH Alter Hellweg 46, Dortmund Participation I would like to take part in the International Fresenius BIOCONTROL Conference Biopesticides Biofertilisers Biostimulants, 5 and 6 June 2018 in Mainz/Germany. Fee: 1, plus VAT. I am a representative of an authority or a public university and therefore eligible for a reduced fee of plus VAT (please provide evidence). The reduced fee cannot be combined with other rebates. I would like to take part in the evening event on 5 June 2018 (included in the above price). Event Documentation Unfortunately, I am unable to attend. Please send me the complete documentation for plus VAT. Trade Exhibition Please send me information on available options for trade exhibition and presenting product information. Your Account Number (if available) Title / First name / Name Position Department Phone / Fax Company (complete company name including legal form) Street / Number or P.O. Box / Building ZIP-code / City / Country Your order number / Cost unit (if required) Your VAT ID No. (for registrations from EU countries except Germany) Date Signature Terms of Participation and Purchase The registration fee includes the event participation, event documentation, lunch, coffee breaks, beverages as well as the evening event. You will receive written confirmation of your registration. Upon receiving our invoice, please transfer the amount due without further deductions before the event begins. The price of the event documentation includes a hard copy of the documentation as weii as an access code to the secure Akademie Fresenius download area. Both the documents and the secure access code will be dispatched around two weeks after the event and as soon as advance payment has been received. Group Reductions For joint bookings received from one company we grant a 15% discount from the third participant onwards. Terms of Cancellation Written cancellations or transfers will be accepted free of charge up to four weeks prior to the start of the event. After this date and up to a week prior to the start of the event we will reimburse 50% of the registration fee. We cannot, unfortunately, provide refunds for later cancellations. Please note that you can name a substitute free of charge at any time. General Terms and Conditions By registering, you agree to our General Terms and Conditions as well as to our Privacy Policy. You can find our GTC on the internet ( or receive them on request. Personal Data The Akademie Fresenius will keep your data for the purpose of organising this event. We will under no circumstances use your data for commercial trade purposes. In signing this form you consent to our occasionally contacting you by mail, , fax or phone (please strike through if unwanted) in order to provide you with further information from our company. You can, of course, withdraw your consent whenever you wish. Occasionally we go around taking photos at our events. These are then published anonymously on our website. Further information can be found at: Picture Credit Peter Jurik, guy - Fotolia.com, SusaZoom - Fotolia.com Billing Address (only if different from the above address) Venue Atrium Hotel Mainz Flugplatzstr. 44, Mainz/Germany Phone: info@atrium-mainz.de, We have reserved a limited number of rooms for our participants at reduced rates at the hotel. These rooms can be booked up to four weeks prior to the start of the event. Please book early and directly through the hotel quoting Fresenius as reference.