Food Safety and Dietary Risk Assessment

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DIE AKADEMIE FRESENIUS Where Experts Meet! 16 th International Fresenius Conference Food Safety and Dietary Risk Assessment 17 and 18 April 2018 in Mainz/Germany Highlights Cumulative risk assessment, evaluation of mixtures Assessing chemical mixtures Development of the EFSA guidance on risk assessment of combined exposure to multiple chemicals A Member State perspective on mixture risk assessment Update on the EuroMix Project Acute risk assessment of the French consumer using the CAG nervous system Assessment of co-formulants Cumulative risk assessment of pesticides in the US Assessment of metabolites Grouping metabolites Genotoxicity assessments on metabolites Acute dietary risk assessment IESTI Impact of a revised IESTI equation on the European MRLs and consumer safety The proposed IESTI revision and its consequences for Codex Relevance of IESTI to minor crops: a developing country perspective Establishment of MRLs Import tolerances and hazard-based cut off criteria: a Member State s view Risk management view on hazard-based cut off criteria MRLs: Implications for international trade and food security The Experts Alan R. Boobis Imperial College London Monika Bross BASF Julie Chao U.S. Department of Agriculture s (USDA) Foreign Agricultural Service (FAS) Evisabel Craig U.S. Environmental Protection Agency (EPA) Christopher Dobe Syngenta Crop Protection Caroline Harris Exponent Christer Hogstrand King s College London Karsten Hohgardt German Federal Office of Consumer Protection and Food Safety (BVL) Susanne Hougaard Bennekou The Danish Environmental Protection Agency (EPA) Carsten Kneuer German Federal Institute for Risk Assessment (BfR) Alexandra Mienné French Agency for Food, Environmental and Occupational Health and Safety (ANSES) Angelo Moretto International Centre for Pesticides and Health Risks Prevention (ICPS) Lucy M. Namu Kenya Plant Health Inspectorate Service (KEPHIS) Christian Prohaska Austrian Agency for Health and Food Safety (AGES) Dieter Schrenk University of Kaiserslautern Trijntje van der Velde-Koerts Dutch National Institute for Public Health and the Environment (RIVM) Jacob van Klaveren RIVM Gaelle Vial French Agency for Food, Environmental and Occupational Health and Safety (ANSES) Bruce Young Bayer Crop Science Division

The Programme Get-Together on Monday, 16 April 2018 Will you arrive on Monday? Come to the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere. Tuesday, 17 April 2018 8.30 Registration and coffee 9.00 Welcome address by Akademie Fresenius and introduction by the Chair Dieter Schrenk, University of Kaiserslautern, Germany Cumulative risk assessment, evaluation of mixtures 9.10 Assessing chemical mixtures Scientific and legislative need to assess chemical mixtures Different approaches used in different regulatory sectors and different geographical regions Need for harmonisation within and between regions, to ensure public health protection and equitable arrangement for trade Issues that need to be resolved Alan R. Boobis, Imperial College London, UK 9.35 Development of the EFSA guidance on risk assessment of combined exposure to multiple chemicals Christer Hogstrand, King s College London, UK 10.00 A Member State perspective on mixture risk assessment What do we do now? Is that enough? What does the data tell us? What is further the needed? Which tools are available? What are the challenges? What are the opportunities? Susanne Hougaard Bennekou, The Danish Environmental Protection Agency (EPA), Denmark 10.25 Panel discussion 10.55 Coffee break 11.25 Update on the EuroMix Project Integrated test strategy Multiple chemicals and multiple exposure routes EuroMix data and model platform User groups and stakeholder involvement Jacob van Klaveren, National Institute for Public Health and the Environment (RIVM), The Netherlands 11.50 Acute risk assessment of the French consumer using the CAG nervous system Alexandra Mienné, French Agency for Food, Environmental and Occupational Health and Safety (ANSES), France 12.15 Assessment of co-formulants Sources of co-formulant data Risk assessment under parallel legislation Co-formulants not approved for use in plant protection products Christopher Dobe, Syngenta Crop Protection, Switzerland 12.40 Panel discussion 13.10 Lunch 14.40 Cumulative risk assessment of pesticides in the US Evisabel Craig, U.S. Environmental Protection Agency (EPA), USA 15.05 Cumulative risk assessment using the CARES NG model a case study evaluating mixtures of plant protection products in the US Population- and calendar-based probabilistic exposure model Aggregate and cumulative exposure model Cloud based exposure model Bruce Young, Bayer Crop Science Division, USA 15.30 Panel discussion 16.00 Coffee break Assessment of metabolites Chair Caroline Harris, Exponent, UK 16.30 Genotoxicity assessments on metabolites QSAR considerations Testing Intake assessment considerations Critical issues Angelo Moretto, International Centre for Pesticides and Health Risks Prevention (ICPS), Italy 16.55 Questions and answers 17.05 Approaches to grouping of metabolites an EU-Member State s perspective Carsten Kneuer, Federal Institute for Risk Assessment (BfR), Germany

17.30 Grouping metabolites industry perspective Industry representative (confirmed) 17.55 Panel discussion 18.20 End of the first conference day 19.00 Departure time for the evening event 9.20 Relevance of IESTI to minor crops: a developing country perspective Lucy M. Namu, Kenya Plant Health Inspectorate Service (KEPHIS), Kenya 9.45 Panel discussion 10.25 Coffee break Establishment of MRLs At the end of the first conference day, Akademie Fresenius invites you to a leisurely evening in the local wine growing region. Enjoy a great meal with wine from the region and continue the day s networking activities in a relaxed atmosphere. Wednesday, 18 April 2018 8.20 Welcome address by the Chair Monika Bross, BASF, Germany Acute dietary risk assessment IESTI 8.30 Impact of a revised IESTI (short-term dietary exposure for pesticide residues) equation on the European MRLs (maximum residue limits) and consumer safety an update Overall impact on the setting of European MRLs and consumer safety Detailed impact of individual parameters on the output of the risk assessment Gaelle Vial, French Agency for Food, Environmental and Occupational Health and Safety (ANSES), France Chair Caroline Harris, Exponent, UK 10.55 Import tolerances and hazard-based cut off criteria: a Member State s view Consequences for international trade Decision making process Impact on implementation of Codex Maximum Residue Limits for Pesticides (CXLs) Christian Prohaska, Austrian Agency for Health and Food Safety (AGES), Austria 11.20 Risk management view on hazard-based cut off criteria A choice between devil and the deep blue sea Karsten Hohgardt, Federal Office of Consumer Protection and Food Safety (BVL), Germany 11.45 MRLs: Implications for international trade and food security The role of trade in meeting global food demand Enhancing the grower toolbox: The need for diverse crop protection tools Global initiatives to advance work on MRLs Julie Chao, U.S. Department of Agriculture s (USDA) Foreign Agricultural Service (FAS), USA 12.10 Panel discussion 13.10 Lunch and end of the conference 8.55 The proposed IESTI revision and its consequences for Codex Relative changes in exposure estimates between current and proposed equations Effect on exposure distribution expressed as a percentage of the ARfD Effect on number of acceptable Codex MRLs Achievements of the CCPR electronic working group IESTI 2017 Trijntje van der Velde-Koerts, Dutch National Institute for Public Health and the Environment (RIVM), The Netherlands Information available online at: www.akademie-fresenius.com/2503

The Experts Alan R. Boobis is a Professor of Toxicology at Imperial College London. He retired from this substantive chair in June 2017 and is now employed part time at the College. He has been a member of the EFSA PPR and CONTAM Panel. He serves regularly as a member/chair of the Joint FAO/WHO Meeting on Pesticide Residues and Joint FAO/WHO Expert Committee on Food Additives and is Chair of the UK Committee on Toxicity. Monika Bross has been working at BASF Agricultural Center in Limburgerhof for more than 20 years. Within BASF she has been involved in all types of residue and metabolism studies, but also in dietary exposure assessment and the preparation of submission documents to authorities (EU, US, JMPR). Monika is chairing the ECPA Residue Expert Group and is a member of related ad-hoc teams on dietary exposure assessment and cumulative assessment. Julie Chao joined the USDA Foreign Agricultural Service (FAS) in 2016 as a Senior Advisor on international pesticide regulatory policy and trade. In her position, she works closely with the U.S. growers and other international, Federal, and State partners to support global agricultural trade and food security. Prior to joining FAS, Julie worked for the U.S. EPA as a pesticide risk manager. Evisabel Craig is a Pharmacologist and Toxicologist and is the Coordinator of cumulative risk assessments at the U.S. EPA s Office of Pesticide Programmes. Christopher Dobe is a Chemist and has been with Syngenta Crop Protection since 2010, and currently leads the Global Regulatory Chemistry group, responsible for global chemical registrations, including a focus on co-formulant sustainability. He is the Chair of the ECPA Chemical Legislation Expert Group, which has been developing the ECPA REACH-IN tools for co-formulants exposure assessment under REACH. Caroline Harris is the Centre Director for Chemical Regulation and Food Safety in Exponent International s UK office. After many years as a Regulator at CRD, she continues to be involved with MRLs, import tolerances and pesticide residues in international trade. She also remains highly active in the field of consumer risk assessment. Christer Hogstrand is a Professor at the Diabetes & Nutritional Sciences Division at King s College London. Besides this role, he is an Expert for the EFSA and currently a member of its Panel on Contaminants in the Food Chain. He has been involved in 12 EFSA working groups and is presently chairing three, including the working group on Chemical Mixtures. Karsten Hohgardt is the Head of the unit responsible for risk management in the field of toxicology and residue behaviour. Since 2006 he has also been Deputy Head of the Plant Protection Products Department at BVL. His main experience lies in MRL setting and residue behaviour. Susanne Hougaard Bennekou is a Senior Advisor in the Pesticide Division of the Danish EPA. As a Regulatory Toxicologist her work also involves risk assessment of biocides and REACH regulated chemicals. She is Vice-Chair of EFSA s PPR panel. Currently, she is involved in developing the EFSA Guidance Document for Harmonisation of Risk Assessment Methodologies for Human Health and Ecological Risk Assessment of Combined Exposure to Multiple Chemicals. Carsten Kneuer is a Toxicologist and the Head of the Unit Toxicology of Active Substances and their Metabolites in the Pesticides Safety Department of the BfR. He started working for the BfR in 2007 as a Senior Scientist Risk Assessment. Alexandra Mienné started working for ANSES as a Risk Assessor in 2012. She has been involved in residue assessment since then, drafting registrations reports and European monographs. Angelo Moretto is a Professor at the University of Milano and the Director of the International Centre for Pesticides and Health Risks Prevention at the University Hospital Luigi Sacco of Milan. He has been involved in the risk assessment of chemicals, especially pesticides, for many years and also in many EFSA projects, including the development of the database on genotoxicity of metabolites of pesticides. He is involved in the EuroMix project. Lucy M. Namu is Chief Analytical Chemist at the Kenya Plant Health Inspectorate Service. Christian Prohaska studied food and biotechnology in Vienna. He worked for public bodies dealing with the risk assessment of plant protection products before he gained a postgraduate degree in toxicology and started working at AGES in 2002. Dieter Schrenk has been a Professor for Food Chemistry and Environmental Toxicology at the University of Kaiserslautern since 1996. In 2005 he took on the full professorship for Food Chemistry and Toxicology. Trijntje van der Velde-Koerts is a Chemist and a Scientific Employee at RIVM in the field of pesticides, biocides and veterinary medicines. She is a member of the Residue Chemistry Expert Group of OECD and an FAO panel member of the JMPR. As part of her work for the WHO Collaborating Centre at RIVM, she prepares the JMPR models for the pesticide residue dietary exposure estimates. Jacob van Klaveren has worked for RIVM as Senior Scientific Advisor since 2010. He coordinates the R&D programme on food safety for Wageningen Research, the EU funded ACROPOLIS project and the EFSA-RIVM partnership on the follow-up ACROPOLIS. Since 2015 he is coordinating the EuroMix project. Gaelle Vial started working for ANSES in 2007 and has been in charge of pesticide risk assessment for consumer safety. She is involved in active substance approbation, plant protection products assessment as well as in relations with laboratories on monitoring programmes and post regulation risk assessment. Bruce Young has been working at Bayer Crop Science Division for 27 years in ecological and human risk assessment and is currently responsible for assessing aggregate and cumulative dietary and residential assessments. He is the Technical Expert for both the Cumulative Aggregate Risk Evaluation System and the Residential Exposure Joint Venture.

About Who do you meet? Groups that should take part: Managing directors, boards of directors, managers, consultants and scientists in the fields of Quality assurance & control Product safety Legal & regulatory affairs Registration and authorisation Toxicology Risk assessment Research & development Sectors that should take part: Food industry Food retailing Agrochemical industry Authorities (e.g. agricultural and food inspection offices, registration and control autorities) Laboratories Research institutes Professional associations 18 and 19 June 2018 in Mainz 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. Rebecca Keuters phone: +49 231 75896-76 rkeuters@akademie-fresenius.de 20 th International Fresenius AGRO Conference "Behaviour of Pesticides in Air, Soil and Water" 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 www.akademie-fresenius.com Please order information now! info@akademie-fresenius.com www.akademie-fresenius.com/2502 Do you have any questions? Programme and conceptual design Sabine Mummenbrauer phone: +49 231 75896-82 smummenbrauer@akademie-fresenius.de Organisation and participant management Danielle Sörries phone: +49 231 75896-74 dsoerries@akademie-fresenius.de

Registration By web www.akademie-fresenius.com/2503 By email registration@akademie-fresenius.com By fax +49 231 75896-53 Hotline +49 231 75896-50 Die Akademie Fresenius GmbH Alter Hellweg 46, 44379 Dortmund Participation I would like to take part in the 16 th International Fresenius Conference "Food Safety and Dietary Risk Assessment", 17 and 18 April 2018 in Mainz/Germany. Fee: 1,895.00 plus VAT. I am a representative of an authority or a public university and therefore eligible for a reduced fee of 795.00 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 17 April 2018 (included in the above price). Event Documentation Unfortunately, I am unable to attend. Please send me the complete documentation for 295.00 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 Email 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 Billing Address (only if different from the above address) 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 (www. akademie-fresenius.com/general-terms) 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, email, 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: www.akademie-fresenius.com/dataprotection. Picture Credit SusaZoom fotolia.com Venue Atrium Hotel Mainz Flugplatzstraße 44, 55126 Mainz/Germany Phone: +49 6131 491-0 info@atrium-mainz.de, www.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.