FOOD SAFETY AND DIETARY RISK ASSESSMENT

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12 th International Fresenius Conference FOOD SAFETY AND DIETARY RISK ASSESSMENT 5 and 6 March 2014 in Mainz (near Frankfurt)/Germany HIGHLIGHTS: Mode of action in cumulative risk International developments in combined exposures and mode of action Implementation of cumulative risk at EU level Relevance of dissimilar mode of action Combined exposures of multiple pesticides and contaminants Models and methods in risk of pesticides Overview of the U.S. EPA s Office Pesticide Programs Dietary Exposure Models and Tools ACROPOLIS final results and follow-up Uncertainty in exposure and risk Stereoisomers How to solve the problem of mirror images? Application of the TTC concept in Europe New data requirements OECD Guidance Document on crop field trials New data requirements regarding proportionality Maximum Residue Limits (MRLs) Recent and future developments in EU legislation JMPR principles of MRL setting Modernisation of the registration system in Japan THE EXPERTS: Ursula Banasiak Federal Institute for Risk Assessment (BfR) Alan R. Boobis Imperial College London Monika Bross BASF Florence Gérault Regional Service Plant Protection (SRPV) Caroline Harris Exponent Andy Hart The Food and Environment Research Agency FERA Karsten Hohgardt Federal Office for Consumer Protection and Food Safety (BVL) Susanne Hougaard Bennekou Danish Environmental Protection Agency (EPA) Andreas Kortenkamp Brunel University London Frank Laporte Bayer CropScience Neil Lister Syngenta Bette Meek University of Ottawa Hermine Reich European Food Safety Authority (EFSA) Dieter Schrenk University of Kaiserslautern Kristina Schuierer Federal Office for Consumer Protection and Food Safety (BVL) Claire Stephenson Chemicals Regulation Directorate (CRD) Jane Stewart BASF Julie van Alstine U.S. Environmental Protection Agency (EPA) Jacob van Klaveren National Institute for Public Health and the Environment (RIVM) Claude Vergnet French Agency for Food, Environmental and Occupational Health & Safety (ANSES) Yukiko Yamada International Food Safety Consultant LeARN the LAteSt DeVeLopMeNtS in RiSK ASSeSSMeNt of pesticide ReSiDUeS in FooD!

THE PROGRAMME Get-Together on Tuesday, 4 March 2014 Wednesday, 5 March 2014 8.30 Registration & coffee 9.00 Welcome address by the organisers and introduction by the Chair Dieter Schrenk, University of Kaiserslautern, Germany Mode of action in cumulative risk 9.10 International developments in combined exposures and mode of action / species concordance analysis WHO/IPCS combined exposures framework; tiered analysis; case studies; recent developments Update of WHO/IPCS mode of action / species concordance framework Importance of problem formulation and uncertainty/ sensitivity analysis Bette Meek, University of Ottawa, Canada 9.40 Implementation of cumulative risk at EU level state of the play Development of methodologies to be used for assessing exposure to multiple pesticides Do we have all the data required to perform cumulative risk s? How to make sure that the relevant risk management questions are addressed adequately? Hermine Reich, European Food Safety Authority (EFSA), Italy 10.10 Grouping of pesticides for cumulative risk : Relevance of dissimilar mode of action Cumulative risk of pesticides Toxicological profile Cumulative grouping Mode of action and dissimilar mode of action Susanne Hougaard Bennekou, Danish Environmental Protection Agency (EPA), Denmark 10.40 Panel discussion 11.10 Coffee break 11.40 UK authority view on cumulative risk UK regulatory position on cumulative risk to date Current state of the art Future steps and risk management issues Costs and benefits Will you arrive on Tuesday? Come to the hotel bar at 8 p.m. and meet other participants and speakers in a relaxed atmosphere. Claire Stephenson, Chemicals Regulation Directorate (CRD), Health and Safety Executive (HSE), UK 12.10 towards evaluating combined exposures to multiple pesticides and contaminants in food safety s Cumulative risk Pesticide authorisation Criteria for the grouping of substances for cumulative risk Role of modes of action in selecting mixture approaches Andreas Kortenkamp, Brunel University London, UK 12.40 Panel discussion 13.00 Lunch Chairperson: Monika Bross, BASF, Germany Models and methods in risk of pesticides 14.30 Ways forward for cumulative risk of pesticide residues in food, an industry perspective Purpose and context of cumulative risk Hazard and definition of cumulative groups Methods and data needed for cumulative exposure Tentative impact analysis Frank Laporte, Bayer CropScience, France 15.00 Overview of the U.S. Environmental Protection Agency s (U.S. epa s) Office Pesticide Programmes (opp) dietary exposure models and tools Dietary Exposure Evaluation Model (DEEM) Food Commodity Intake Database (FCID) National Health and Nutrition Examination Survey/ What We Eat In America (NHANES/WWEIA) Joint Institute for Food Safety and Applied Nutrition (JIFSAN) Julie van Alstine, U.S. Environmental Protection Agency (EPA), USA 15.30 Panel discussion 15.50 Coffee break 16.20 ACRopoLIS final results and follow-up Final results exposure models Final results toxicological testing Second ACROPOLIS stakeholder conference Potential follow-up Jacob van Klaveren, National Institute for Public Health and the Environment (RIVM), The Netherlands 16.50 Uncertainty in exposure and risk Andy Hart, The Food and Environment Research Agency FERA, UK

17.20 Panel discussion 17.40 End of first conference day 18.30 Departure time for the evening event Thursday, 6 March 2014 8.30 Stereoisomers How to solve the problem of mirror images? Neil Lister, Syngenta, UK 9.00 Application of the ttc concept in Europe Outline of the TTC concept Recent developments in Europe Current and on-going activities Future prospects Alan R. Boobis, Imperial College London, UK 9.30 Panel discussion 9.50 Coffee break Chairperson: Caroline Harris, Exponent, UK New data requirements 10.20 oecd Guidance Document on crop field trials Development of the OECD Guidance Document Aspects covered by the OECD Guidance Document Global data set Proportionality Karsten Hohgardt, Federal Office of Consumer Protection and Food Safety (BVL), Germany 10.50 New data requirements regarding proportionality Proportionality Jane Stewart, BASF, USA After the first conference day Akademie Fresenius would like to invite you to a leisurely evening at the vinegard Dautermann in the wine-growing region Rheinhessen. You have the opportunity of better getting to know other participants you met during the day over a relaxed meal. 11.20 Ideas for an EU Guidance Document on the level of residues in fish Residues in fish why? Fish feed in aquaculture Ideas on the content of a guidance document for residues in fish Kristina Schuierer, Federal Office of Consumer Protection and Food Safety (BVL), Germany 11.50 Panel discussion 12.20 Lunch Maximum Residue Limits (MRLs) 13.20 Recent and future developments in EU legislation Florence Gérault, Regional Service Plant Protection (SRPV), France 13.50 French point of view on European MRL setting procedure Review of MRLs according to article 12 of 396/2005: workload, delays and consequences (AIR dossiers and PPP registration) MRLs modifications and zonal evaluation of PPPs Claude Vergnet, French Agency for Food, Environmental and Occupational Health & Safety (ANSES), France 14.20 JMPR principles of MRL setting Group MRLs Alternative GAPs Proportionality approach TTC concept for metabolites and degradation products Ursula Banasiak, Federal Institute for Risk Assessment (BfR), Germany 14.50 Modernisation of the registration system in Japan Registration Harmonisation Yukiko Yamada, International Food Safety Consultant, Japan 15.20 Panel discussion 15.50 Concluding remarks by the Chair and end of the conference Save the Date! International Fresenius Conference Nanotechnology in Food 19 and 20 May 2014 in Mainz / Germany www.akademie-fresenius.com/2165

THE EXpeRTS The experts Ursula Banasiak worked for over 30 years in the field of dietary risk of pesticide residues in food. The last eight years she was the Head of the department Chemicals Safety at the BfR in Berlin. She is a member of the FAO Panel of the FAO/WHO JMPR. Alan R. Boobis is Professor at Imperial College London and is Director of the Public Health England Toxicology Unit. He has been a member of the EFSA PPR Panel and the Panel on Contaminants in the Food Chain. He is co-chair of the Joint FAO/ WHO Meeting on Pesticide Residues and chair of the Joint FAO/WHO Expert Committee on Food Additives. Monika Bross has been working at BASF for more than 15 years. She is member of the ECPA Residue Expert Group, the ECPA Dietary Risk Assessment Project Team and for Crop Life International the OECD Residue Expert Team. Florence Gérault works at the Regional Service Plant Protection (SRPV) of the Loire region in France. Caroline Harris is Director of the Centre for Chemical Regulation and Food Safety at Exponent. She worked for 20 years in the UK's PSD, as a temporary adviser to the JMPR and is currently a member of the UK's Advisory Committee on Pesticides. Andy Hart has been exploring the use of probabilistic methods to quantify variability and uncertainty in risk for many years. He was a EFSA PPR Panel member and works at FERA in the UK. Karsten Hohgardt is 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 Department Plant Protection Products at BVL. His main experience lies in MRL setting and residue behaviour. Susanne Hougaard Bennekou worked for around 15 years with regulatory toxicology. Since 2009 she has been a member of the PPR Panel and has been vice-chair the past 2½ years. She participated in several EFSA workgroups and is currently in the working group for the opinion on the relevance of dissimilar mode of action. Andreas Kortenkamp is Professor at the Institute for the Environment, Brunel University London. He was responsible for the State of the Art Report on Mixture Toxicology of the EU Commission. He served as an external expert on EFSA working groups. Frank Laporte has been working in the area of residue chemistry and dietary risk at Bayer CropScience since 1999. He was involved in the development of the OECD MRL calculator and in the evaluation of the proportionality principle. He is a member of the ECPA Residue Expert Group. Neil Lister is currently Syngenta s Technical Manager for Operator and Consumer Safety. Neil s other roles have included working in dietary risk and leading the residue development activities for new active ingredients. He is a member of ECPA's Residue Expert Group and of CropLife's Consumer Safety Project Tea. Bette Meek is Associate Director of Chemical Risk Assessment at the McLaughlin Centre, Institute for Population Health, University of Ottawa. She was involved in areas such as weight of evidence analysis for Mode of Action and combined exposures and predictive modeling. Hermine Reich is working for EFSA since 2006, being in charge of the implementation of the provisions of the MRL Regulation (EC) 396/2005. Her background is in food chemistry, food technology and biotechnology. Before joining EFSA, she was working for the Austrian Food Safety Agency. Dieter Schrenk has been 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. Kristina Schuierer holds a Master in Nutrion Sciences. She joined the BVL in 2012, working with procedures for setting MRLs according to Regulation (EC) 396/2005. Currently, she develops an EU Guidance Document on the level of residues in fish. Claire Stephenson has been working as a Senior Scientist within the Exposure and Chemistry Branch of CRD since 2005 and is the lead on technical aspects of MRLs. She represents the UK as a technical expert at a range of EC and EFSA meetings. Jane Stewart is a Senior Research Associate at BASF Agricultural Centre. She is currently industry co-leader for the OECD Residue Chemistry Expert Working Group on crop field trials, participating on the working group for Livestock Guidance and working on proportionality on behalf of OECD and Crop Life America. Julie van Alstine has worked in the U.S. EPA s Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs, Health Effects Division since 2008 on chemistry, dietary, and risk s. She contributed to the update of the DEEM Model. Jacob van Klaveren works at RIVM and is the coordinator of the EU funded project ACROPOLIS since 2010. Previously, he worked for RIKILT Institute of Food Safety where he managed the strategic food safety research programme addressing risk issues for pesticides and other chemicals. Claude Vergnet joined ANSES in 2006 and is currently heading the Unit in charge of consumer risk of pesticides and biocides. Previously, he worked at INRA, the French Institute for Agricultural Research. Yukiko Yamada holds a PhD in biochemistry. She has worked in the Codex Alimentarius Commission Secretariat, and the Ministry of Agriculture, Forestry and Fisheries, Japan and retired in March 2013 as the Director-General for Technological Affairs / Chief Scientific Officer. She has been a member of JMPR since 2002.

YOU WILL Meet Groups that should take part: Professionals working in the fields of Quality assurance and control Product safety Risk Regulatory affairs, regulatory science Registration Research and development Sectors taking part: Food industry Agrochemical industry Regulatory authorities Research institutes Scientific consultants 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. Tina Bayati Phone: +49 231 75896-73 tbayati@akademie-fresenius.de The organisers AKADEMIE FRESENIUS is a joint venture of SGS Institut Fresenius and COGNOS, one of the leading private educational institutes in Germany. Akademie Fresenius organises national and international conferences and congresses on current topics from the economic and scientific sectors for both specialists and the industry. You can find details on upcoming and new events at www.akademie-fresenius.com Consumer protection is becoming increasingly important and the legal requirements in regard to quality assurance in the production and use of food have become much more stringent. As an accredited partner, SGS INSTITUT FRESENIUS offers fast and competent assistance in all analytical and hygiene-relevant issues concerning food. Vast experience in analytical sciences and most recent analytical equipment is used to develop and validate methods relevant for the quality of pesticide products and monitoring of pesticide/metabolites residues and other contaminants at trace levels. Customers also benefit from many years of experience in the of legal issues in this field. www.institut-fresenius.de For questions regarding the organisation: Annika Koterba phone: +49 231 75896-74 email: akoterba@akademie-fresenius.de For questions regarding the programme: Anja Glinschert, PhD phone: +49 231 75896-81 email: aglinschert@akademie-fresenius.de

ReGiStRAtioN By web By mail registration@akademie-fresenius.com By fax +49 231 75896-53 participation Yes! I would like to take part in the 12 th International Fresenius Conference Food Safety and Dietary Risk Assessment, 5 to 6 March 2014 in Mainz/Germany. Fee: 1,695.00 plus VAT. Yes! I am a representative of an authority or a public university and therefore eligible for a reduced fee of 795.00 plus VAT per person (please provide evidence). The reduced fee cannot be combined with other rebates. I would like to take part in the evening event on 5 March 2014 (included in the above prices). Yes No i nfo-hotline: +49 231 75896-50 Die Akademie Fresenius GmbH Alter Hellweg 46, 44379 Dortmund, Germany CoNFeReNCe DoCUMeNtAtioN No! Unfortunately, I am unable to attend. Please send me the complete conference documentation for 295.00 plus VAT (hard copy and electronic version). trade exhibition Yes! Please send me information on exhibition possibilities during the event. Your account number (if available): title / First name / Name Position Department / Building 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 O Signature Billing Address (only if different from the above address) WEB terms of participation AND purchase The registration fee includes the conference participation, complete conference documentation, lunch, coffee breaks, conference beverages as well as the evening event on 5 March 2014. You will receive written confirmation of your registration. Upon receiving our invoice, please transfer the amount due without further deductions before the conference begins. The price of the conference documentation includes a hard copy of the documentation as weii as an access code to the secure Akademie Fresenius download area where you can download the complete conference documentation, including any subsequent updates, in electronic form subject to the approvai of the respective speakers. 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 General Terms and Conditions on the internet (www.akademie-fresenius.com/general-terms) or receive them on request. personal DAtA The Akademie Fresenius will keep your personal 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. Further information can be found at: www.akademie-fresenius.com/dataprotection. VENUE/CONFERENCE HOTEL Atrium Hotel Mainz, Flugplatzstrasse 44, 55126 Mainz/Germany phone: +49 6131 491-0, fax: +49 6131 491-128 email: 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.