MEET THE InnovatingConferenceSPEAKERSonMicrobialPesticideTesting 13-16 September 2022
Australian Pesticides and Veterinary Medicines Authority (APVMA)
Speakers and Panellists2 Session 1: Regulatory Requirements for Human Health Testing and Current Test Guidelines for Mammalian Testing and Opportunities for Developing Alternative Methods
Christopher Lythgo
Australia Dr. Maria Trainer is currently the acting Executive Director, Registration Management at the Australian Pesticides and Veterinary Medicines Authority. Before joining the APVMA in April 2019 as Director of Pesticides Registration, Maria held senior positions in both the private and public sectors in her adopted second home of Canada. This includes more than seven years as Managing Director for Science and Regulatory Affairs with CropLife Canada and three years as Program Director with the Council of Canadian Academies where she had the lead responsibility for the Expert Panel on the Integrated Testing of Pesticides. Maria has also worked as a scientific evaluator with the New Substances Bureau of Health Canada and has experience in human health toxicological risk assessment. Maria holds a PhD in Bacterial Molecular Genetics from the University of Waterloo, a Master’s degree in Biochemistry from Washington State University, and two Bachelor of Science degrees from the University of Idaho. Originally hailing from the United Kingdom, Maria loves to travel. In her free time she can generally be found outdoors, usually on a bike.
Maria Trainer
European Food Safety Authority EU Mr Chris Lythgo has since 2005, been a Team Leader of one of the risk assessment teams in the Pesticides Peer Review Unit of the European Food Safety Authority (EFSA) which is based in Parma Italy. Chris is involved in the peer review of the Draft Assessment Reports prepared by the Competent Authorities of the EU Member States. Prior to his current role Chris worked for 11 years at the Pesticide Safety Directorate, which was the Competent Authority for the authorisation of plant protection products in the UK. In these roles he has been involved in reviewing and concluding on the risk assessments resulting from the use of plant protection products containing microorganism strains that supported decision making on approvals and authorisations, primarily in the fields of identity and specifications + consumer and environmental exposure. Prior to these roles in regulatory risk assessment he was an analyst in a UK government control laboratory (3 years) and in the food manufacturing industry (4 years). He received his M.S. in Biotechnology / Bioreactor Systems from the University of Manchester Institute of Science and Technology, UK and B.S. in Crop Science from the University of Leeds, UK.
José Carvalho European Regulatory Lead for Certis BiologicalsGermany José Carvalho holds a PhD in Environmental Chemistry from the Humboldt University in Berlin and a Master in Pharmaceutical Sciences from Porto University, with a focus on microbiology, antibiotics resistance and immunology. Previous to joining the industry, Jose worked for the Portuguese Water Institute, the French National Institute for Agricultural Research (INRA) and the German Federal Institute for Material Science and Testing (BAM) in analytical methods, publishing 11 peer-reviewed articles and 3 book chapters. Since 2020, José is working as European Regulatory Lead for Certis Biologicals and prior to that in several regulatory positions within the crop protection industry. He is currently the Chair of the Microbial Professional Group at IBMA (International Biocontrol Manufacturers Association), the biocontrol industry’s expert group dealing with microorganism registrability issues for microorganism-based technologies in agriculture.
Dr. Zorrilla has been involved in a broad range of industry expert groups recommending testing paradigms and safety evaluation strategies for biopesticides, biostimulants and biochemicals. She co-lead a human safety working group with the European Biostimulant Industry Council (EU), and has supported Biopesticide Industry Alliance (USA), OECD Expert Group on Biopesticides, International Biocontrol Manufacturers Association (EU) and Crop Life International. She has also provided technical expertise and review on human safety requirements for biopesticides for countries in North, Central and South America, Asia-Pacific, China, Africa and Europe. Her expertise has been critical in defining the human safety testing paradigms for biological pesticide registrations, both through external working groups and internally at Bayer Crop Science.
Leah Zorrilla, Regulatory Toxicology, North America Lead Bayer Crop Science, Chesterfield, Missouri, USA
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Dr. Zorrilla holds a Doctorate Degree in Comparative Biomedical Sciences from North Carolina State University (USA), and a Bachelors Degree in Animal Science from the University of New Hampshire (USA). She trained at the US Environmental Protection Agency (EPA) as a postdoctoral fellow in Reproductive and Endocrine Toxicology and worked as a study director and program manager at a US-contract laboratory prior to joining Bayer in 2013.
Leah Zorrilla, PhD, is the Regulatory Toxicology Lead for Human Safety North America and Global Human Safety Lead for Biologics at Bayer Crop Science in Chesterfield, Missouri, USA. She directs and manages a team of regulatory toxicologists responsible for the development and support of North America-registered active ingredients and globally registered biopesticides, biostimulants and biochemicals.
Speakers and Panellists4
Dr. Nicole Kleinstreuer is the acting director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), the US federal resource for alternatives to animal testing. At NICEATM, she leads domestic and international efforts to develop novel testing and analysis strategies that provide more rapid, mechanistic, and human-relevant predictions of potential environmental chemical hazards. Kleinstreuer’s research focuses on mathematical and computational modeling of biological systems and their susceptibility to perturbations that result in adverse health outcomes. She has a secondary appointment in the NIEHS Division of Intramural Research Biostatistics and Computational Biology Branch, and adjunct faculty positions in the Yale University School of Public Health and the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. She has published over 100 peer-reviewed publications and won numerous awards, including the 2019 Society of Toxicology Achievement Award, the 2016 Young Researcher Americas Award from the Lush Prize Foundation, the 2012 US EPA Office of Research and Development Impact Award, and the 2008 B.H. Neumann Prize from the Australian Mathematical Society.
Session 2
Philip Marx-Stoelting German Federal Institute for Risk Assessment (BfR), Germany After successfully completing the training to become a paramedic, Philip Marx-Stoelting studied biochemistry and philosophy in Tübingen/Germany and Brisbane/Australia. He completed his PhD-thesis (Dr. rer. nat.) in biochemistry/ toxicology on chemically induced hepatocarcinogenesis in the group of Michael Schwarz where he also assisted in coordinating the EU-FP7-project ReProTect. Philip joined the German Federal Institute for Risk Assessment (BfR) in 2008 where he worked in several positions in regulatory and experimental toxicology. Currently he serves as head of the unit ‘Testing and assessment strategies pesticides’ in the pesticides safety department and is head of the BfR working group on endocrine disruptors. He served in several international expert panels (EFSA PRAS, EFSA PREV, OECD WPHA) and is a member of the OECD EDTA. Philip is co-author of more than 50 peer reviewed publications and text book chapters and is teaching toxicology at TU Berlin and Charité. He was/is involved in the EU H2020 funded projects EuroMix, RiskHunt3R and EDCmet and in coordinating the BMBF funded project Combiomics as well as WP5 of PARC. His research interests are liver toxicity, endocrine disruption and mixture effects. He is a specialist in toxicology (Fachtoxikologe, DGPT) / Eurotox registered toxicologist (ERT). - Overview of New Approach Methodologies (NAMs) and Other Ongoing Research in Testing Methodologies
Nicole Kleinstreuer NIH, UnitedNICEATM,States
Valérie Fessard French Agency for Food, Environmental and Occupational Health & Safety (Anses),France
Christopher Faßbender
David Allen
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Valérie FESSARD heads the Toxicology of contaminants group of the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) in Fougères, France since 2008. She received a PhD in toxicology in Paris 7 early 1996 dealing with the toxicity of phycotoxins. After a post-doctorate on ecotoxicology in NERC Plymouth Marine Laboratory (UK) with a grant of the European Science Foundation, she came back to France in 1997 and dedicated her scientific work to human toxicology. First involved in the set-up of new genotoxicity assays, she aimed to applying the strategy of genotoxicity testing used for chemicals to natural compounds such as non-microbial toxins (principally phycotoxins and cyanotoxins). Nowadays, the unit contributes to hazard evaluation of food contaminants and to improve the prediction of toxicological assays.
PETA Science Consortium InternationalGermanye.V.
David Allen, Ph.D. is the Vice President of Inotiv, Inc. with over 20 years of experience in regulatory toxicology, test method evaluation, and in vitro biology. In addition to his responsibilities as Director of the Research Triangle Park Inotiv site, Dr. Allen provides scientific leadership, management, and direction to technical programs, overseeing a variety of government and commercial projects associated with the application of in vitro and in silico approaches to identifying potential hazards. He is the Principal Investigator of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) support contract, providing scientific oversight of all projects and senior leadership for all Inotiv staff working on the current contract. Dr. Allen participates in local, national, and international meetings relevant to new approach methodologies. He has been a member of international Validation Management Teams for in vitro alternative test methods, during which he provided input on validation study design, data analyses, and test method recommendations. He also has participated on international expert consultations for new and revised OECD Health Effects Test Guidelines for alternative test methods. Dr. Allen is Past President of the American Society for Cellular and Computational Toxicology and is a Past President of the Society of Toxicology (SOT) In Vitro and Alternative Methods Specialty Section, and was the recipient of the 2017 SOT Enhancement of Animal Welfare Award.
V. Fessard works in promoting the 3R rules in research through the development of in vitro models for intestine and liver and the reduction of animal experimentation. Since 2014, she has been working on microbial toxic agents such as Bacillus cereus and Clostridium perfringens and more recently on B. thuringiensis in close collaboration with the Anses laboratory of Maisons-Alfort (Salmonella, Bacillus, Clostridium and Listeria unit) and the Pasteur Institute in Paris. On this topic, the research has focused on the use in vitro toxicity assays to check the potential toxicity, to investigate the interaction of bacteria with intestinal cells, to help prediction of pathogenicity and identify the key drivers involved.
Integrated Lab UnitedSystems,States
Christopher Faßbender is an advisor to PETA Science Consortium International e.V. He received his PhD in biology from the University of Heidelberg, Germany, and has research and teaching experience in aquatic ecotoxicology and zoology. Prior to joining the Science Consortium in 2014, he worked in industry, where he assisted in the registration of pesticides. Now, he advises the Science Consortium on the testing of animals and non-animal approaches with regard to ecotoxicology. He is involved in leading two OECD projects on the Test Guidelines Programme work plan: the first investigates ways to reduce the number of fish used in tests that require solvents, and the second is to develop Integrated Approaches to Testing and Assessment to predict acute fish toxicity.
US Environmental Protection Agency (US EPA), United States Dr. Geoffrey Sinclair is a senior scientist in the Risk Assessment Branch in the Biopesticides and Pollution Prevention Division (BPPD) in the Office of Pesticide Programs at the U.S. Environmental Protection Agency. He got his Ph.D. in biological oceanography at North Carolina State University before becoming an Assistant Professor at the Louisiana Universities Marine Consortium. His research focused on physiological stress responses and gene expression in marine microbes. He joined the Office of Pesticide Programs in 2013 as a risk assessor in the Environmental Fate and Effects Division and served as a Team Lead in the Antimicrobial Division before joining BPPD as a senior scientist. He currently leads teams in the ecological assessment of microbial, biochemical and emerging biotech pesticides. He has advised the division on several novel technologies that range from the Oxitec mosquito to bee vectored microbial pesticides.
Speakers and Panellists6
Session Regulatory Requirements for Non-target Organisms
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Emma Babij Pest Management Regulatory Agency (PMRA), Canada Emma Babij is the Section Head of the Microbial and Biochemical Evaluation Section of PMRAHealth Canada. A toxicologist by training, Emma holds a Master of Science in Biomedical Toxicology and Nutritional Sciences from the University of Guelph. Prior to joining Health Canada, Emma worked for a toxicology consulting group assisting clients in preparing regulatory dossiers. In 2009, Emma joined the Microbial and Biochemical Evaluation Section in the Health Evaluation Directorate of PMRA, where she conducted pre- and post-market hazard evaluations and exposure assessments for non-conventional pesticides, including biochemicals, essential oils, plant growth regulators, and pheromones. As a Senior Scientific Evaluator she contributed to policy development and Agency projects, and participated in working groups examining modernized and alternative approaches to toxicological testing and risk assessment at the national and international level with regulatory, academic, and industry groups. Emma moved into the role of Head of the Microbial and Biochemical Evaluation Section in 2021 where she leads an experienced team conducting human health risk assessment of all classes of biopesticides, and product characterization and environmental risk assessment of microbial pesticides.
Geoff Sinclair
Roma has been an expert for regulation of biopesticide, working with OECD, the EU, and FAO/WHO and has also been involved in the development of some national biopesticide regulatory guidance, internationally. Roma is also a consultant on several biopesticide collaborative research and PhD projects and runs workshops on aspects of biopesticide technology for industry and universities.
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Roma is an independent board member for the UK Agriculture and Horticulture Development Board (Horticul ture), Vice-President of International Biocontrol Manufacturers Association and a Board member (Biopesticide In dustry representative) of the International Association of Plant Protection Sciences (IAPPS). Roma in involved with several farmer and grower projects and is a member of the steering committee for the AHDB-Horticulture project SCEPTRE+. She was editor of the internationally regarded publication ‘The Manual of Biocontrol Agents’ published by BCPC and supports CABI in the development of their Bioprotection portal (www. bioprotectionportal.com).
Roma Gwynn is a biopesticide specialist working within this area for nearly 40 years initially as a research scientist then working for biocontrol companies and now as an independent specialist working internationally. She has an MSc in Technology for Crop Protection and a PhD in Biological Control, both from Reading University, UK. Roma has taken a lead role in the development and registration of many new biopesticide technologies in the EU and internationally, including semiochemical, botanical and microbial substances. Her expertise is in facilitating the process of getting biopesticide products onto the market by streamlining bio-discovery, product develop ment, registration and marketing, with particular expertise on efficacy.
Speakers and Panellists
Roma Gywnn
Emily McVey Board for the Authorization of Plant Protection Products and Biocides (Ctgb), The Netherlands Emily McVey serves as an expert in vertebrate toxicology and adverse outcome pathways (AOPs) at the Ctgb (Dutch competent authority for pesticides and biocides) where she has worked as an ecotoxicologist for the last decade. Emily completed her PhD in neurovirology, neural development and molecular medicine at the Johns Hopkins School of Medicine, with a minor in Environmen tal Health from the Johns Hopkins Bloomberg School of Public Health. She previously worked as a toxicologist at the US Food and Drug Administration, Center for Drug Evaluation and Research (USFDA, CDER).
UnitedBiorationale,Kingdom
Ecological/Non-Target Test Guidelines – Outlining the Issues
A.T. Alkassab works since 2017 as a researcher of the Institute for Bee Protection in the JKI. The current research activities focus on bee health in relation to the exposure to pesticides, including bio-pesticides, and nutrition.
Sessionaspects.4:Current
Speakers and Panellists8
A.T. Alkassab finished his dissertation “Dr. rer. nat.“ in 2017, Ruhr-Universität Bochum, Germany. He is also active in international gremia like the ICPPR (International commission plant bee relationships), OECD and EFSA in various expert groups. He serves as reviewer in various international journals like “Journal of Experimental Biology, Environmental Pollution, Ecotoxicology ...etc”. Furthermore, he is a beekeeper and has his private hobby apiary.
Bilgin Karaoglan German Environment Agency (Uba), Germany Bilgin Karaoglan is a Scientific Officer at the German Federal Environment Agency (UBA). He has over 15 years of experience in ecotoxicology and environmental risk assessments in the context of approval and authorisation procedures of plant protection products. Since 2008 he regularly participated in meetings and seminars of the OECD Biopesticides Steering Group (later renamed Ex pert Group on Biopesticides) and also contributed in the development of Guidance Documents for biopesticides, especially microorganisms used as plant protection active substances. He obtained a Diploma in Biology at Goethe University Frankfurt in 2005. During his diploma thesis, he gained practical experience with ecotoxicological test methods and validation
A.T. Alkassab conduct several research projects to develop method for testing and investigating the effects of plant protection products on honey bees, bumblebees and solitary bees under laboratory, semi-field and field conditions. Further researches are related to investigation the interaction of different stressors, including food limitation, on bee health and colony development in the field. He is active in the area of risk assessment of plant protection products on honey bees and other commercially relevant pollinators.
Abdulrahim Alkassab Julius Kühn Institute, Germany Abdulrahim T. Alkassab works at the Julius Kühn-Institut (JKI), Federal Research Centre for Cultivated Plants, which is both a federal research institute and a higher federal authority.
Mark Whittaker
Henry Krueger
Applied Insect Science Ltd, United Kingdom Mark is an agricultural entomologist with over 20 years’ experience in the biopesticide industry. He started his career as a field consultant for a large multinational biocontrol company, then moved into regulatory affairs before eventually starting his own biopesticide regulatory consultancy in 2007. In early 2012 he opened Applied Insect Science Ltd, a GLP contract research laboratory that specialises in ecotoxicology testing on biopesticides. He was a founding member of IBMA UK, and has spent his career promoting pragmatic science-based approaches to the environmental risk assessment of novel plant protection products.
Lisa Ortego is a Senior Science Fellow, ecotoxicologist, and risk assessor working in Bayer’s North American Environmental Effects and Risk Assessment Team. She is globally responsible for managing environmental safety of biopesticides, biostimulants, and biochemicals, and has North American environmental safety responsibilities for a number of conventional Lisapesticides.received her bachelor’s degree from Louisiana State University in environmental health and her PhD in pharmacology and toxicology from the University of Mississippi. She has been a diplomat of the American Board of Toxicology since 2001. Lisa has over 25 years of experience as an ecotoxicologist and risk assessor in the private sector, and her experience includes chemicals, metals, pesticides, biopesticides, biochemicals and biostimulants.
Lisa is very active providing technical and strategic input on the ecological testing and safety evaluation of biopesticides, biostimulants, and biochemicals. She has supported activities at European Biostimulant Industry Council, Biopesticide Industry Alliance (US), OECD Expert Group on Biopesticides, International Biocontrol Manufacturers Association, and CropLife International. She has also provided technical review and support on environmental safety requirements and testing methods for various countries in South America, Asia-Pacific, Africa and Europe. Separate from her work on biopesticides, Lisa has had a number of leadership roles outside of Bayer including CropLife America’s Environmental Science Policy Steering Group Chair and is currently President of the Society of Environmental Toxicology and Chemistry in North America. Lisa is also responsible for supporting Bayer work on endocrine testing and assessment, has served as the Technical Chair of the Endocrine Policy Forum (industry task force), and participates on the CropLife International’s Endocrine Team.
Dr. Krueger is the VP of Science and Regulatory Affairs at Eurofins AgroScience Laboratories (formerly Wildlife International) in Easton, Maryland. He has been the director and manager of Aquatic, Plant and Insect Toxicology at EAG Laboratories in Easton, Maryland for the last 25 years and manages business and financial affairs, as well as providing technical direction in program coordination and development. His background is in both aquatic and terrestrial ecotoxicology and early in his career at Wildlife International served as Director of Field Programs for 10 years, where he had overall responsibilities for directing activities of mesocosms, terrestrial and aquatic field studies, as well as plant studies conducted in greenhouses. He obtained his M.S. Degree from Central Michigan University and his Ph.D. from the University of Wyoming where he worked at the US Fish and Wildlife Cooperative Research Unit. He has been involved with endocrine studies for over the past 20 years and has served as project manager for endocrine studies that have included mysid, frog, and fish.
Lisa Ortego BayerUnitedCropScience,States
ISpeakers and Panellists
UnitedEurofins,States
He received his PhD from University of Braunschweig and performed a Postdoc at Wageningen University in the Netherlands, before working for state and federal institutes in Germany. In 2012 he was awarded an adjunct professorship at the Technical University of Darmstadt. He has authored more than 120 peer-reviewed publications and book chapters. He was President of the Society of Invertebrate Pathology from 2016-2018 and is Vice President of the IOBC-WPRS since 2021.
Caroline Hauxwell Queensland University of Technology, Australia Caroline is an Associate Professor at Queensland University of Technology, Brisbane (Australia). Her experience in development and research on microbial pesticides spans over 35 years. Her career began as an intern screening chemical agents against soil invertebrates, and went on to specialise in the ecology, biology and laboratory testing of microbial control agents on 5 continents. Her work has contributed to host range, quality control and field testing for registration of new biopesticides and adjuvants (for AgBiTech and others), in risk assessment of genetically modified baculoviruses (with NERC Institute of Virology and Environmental Microbiology, UK), and for quality control of Bacillus thuringensis products (for NovoNordisk). In Australia she leads research that applies molecular analysis, field ecology, and laboratory bioassays to both applied and fundamental research in invertebrate microbiology. This includes the diversity and dynamics of baculovirus variants, the ecology and efficacy of rhizospheric-competent fungi in plant protection, the integration of microbial biopesticides in insecticide resistance management strategies, and the health of bees.
Johannes Jehle is director of the Institute for Biological Control of the Federal Research Center for Cultivates Plants (Julius Kuehn-Institut) in Dossenheim, Germany (www.julius-kuehn.de/ en/bi/).The institute develops methods and strategies for biological control of plant pests and plant diseases for organic and integrated production systems. The aim of Johannes´ scientific work is to improve the application of insect viruses and micro-organisms as biological control agents of pest insects.
Johannes Jehle Julius Kühn Institute, Germany
Session 5: Current Ecological/Non-Target Test Guidelines – Addressing the Issues
Speakers and PanellistsJ 9Speakers and Panellists
SwitzerlandAgroscope, Lara Reinbacher is a scientist at the Research Institute of Organic Agriculture FiBL, Switzerland, where she focuses on the control of insect pests in organic cropping systems. Before joining FiBL in 2022 she did her PhD at Agroscope the Swiss center of excellence for agricultural research on the biological control of wireworms. Here, as well as in her previous work for the AGES – Austrian Agency for Health and Food Safety, Vienna and the Leopold-Franzens-University, Innsbruck, Austria she gained insight in the different aspects of developing microbial plant protection products and the obstacles associated with their registration process. Therefor, she has worked on environmental risk assessment of entomopathogenic fungi. Lara is a trained agronomist with a specialisation in phytomedicine (BOKU – University of Natural Resources and Life Sciences Vienna, Austria).
Anne Steenbergh Board for the Authorization of Plant Protection Products and Biocides (Ctgb), The Netherlands
Five years ago she joined Ctgb (the Dutch Board for the Authorisation of Plant Protection Products and Biocides); first as an assessor and currently as policy officer. In these capacities she has worked on both biopesticides and conventional pesticides. Together with the Ctgb GreenTEAM she enjoys working on any challenges related to the assessment of biopesticides. As member of the EU working group on biopesticides (BPWG) she is actively involved in revising the regulatory framework for microbial pesticides.LaraReinbacher
Anne Steenbergh is a microbial ecologist. She obtained her PhD working on microbial communities in marine sediments (Utrecht University & Netherlands Institute of Ecology).
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