InnovatingPROGRAMMEConferenceonMicrobialPesticideTesting 13-16 September 2022
2 Draft Programme OECD Conference Innovating Microbial Pesticide Testing Day 1 – 13 September 2022 9h30 Welcome by the OECD Patience Browne, Principle Administrator to the OECD Pesticides Programme, OECD Environment Directorate 9h45 Welcome by the CRP and introduction to the Programme
10h30 Regulatory Requirements for Human Health Testing with Microbial Pesticides in Australia
Lieve Herman, CPR Scientific Advisory Body
Maria Trainer, Australian Pesticides and Veterinary Medicines Authority (APVMA), Australia (presentation: 25min; technical Q&A: 5min)
Lythgo, European Food Safety Authority, EU (presentation: 25min; technical Q&A: 5min)
EFSA’s role in the peer review of the risk assessment of plant protection products based on microorganisms: Considerations for improving study Christopherdesigns
The purpose of this topic is based on the vision that if New Approach Methodologies (NAM) replace acute mammalian toxicity / other testing for conventional crop protection products, there is a need to avoid a situation where in vivo / animal testing is only being done for biopesticides / biologicals such as microbial pesticides. This topic is currently unexplored for microbial biopesticides; a goal of this topic is to explore opportunities and be pragmatic about where and when alternative methods can be applied for testing with microbial pesticides.
Session 1: Regulatory Requirements for Human Health Testing and Current Test Guidelines for Mammalian Testing and Opportunities for Developing Alternative Methods
Chair: Jeroen Meeussen, Technical Director Regulatory Affairs, ERM This session will cover the requirements relevant to mammalian toxicity testing in OECD member countries. The initial focus to be on acute mammalian testing, since efforts have been focused here for conventional pesticides and there are might be opportunities to build off those efforts. The aim will be to develop a common understanding of the rationale behind required testing to set the stage for a discussion on NAMs and how we can move microbial pesticides in that 1direction.0h00
Theme: Future Innovation Test Guidelines/Human Health Guidelines
3 Tea/Coffee Break (11h00 11h30)
Chair: Patience Browne, Principle Administrator to the OECD Pesticides Programme, OECD Environment
12h00
14h30
Human Health Risk Assessments for Biopesticides in the US Industry Perspective on Development of Alternative Methods Leah Zorrilla, Bayer CropScience, United States (presentation: 25min; technical Q&A: 5min)
Considerations for Developing In Vitro Studies as Alternatives to Acute Toxicity Testing
David Allen, Integrated Lab Systems, United States (presentation: 25min; technical Q&A: 5min)
Lunch break (12h30 14h00)
Session 2: Overview of New Approach Methodologies (NAMs) and Other Ongoing Research in Testing Methodologies
15h00
Regulatory Requirements for Human Health Risk Assessment in the EU- Industry Perspective on Development of Alternative Methods José Carvalho, Certis Biologicals, Germany (presentation: 25min; technical Q&A: 5min)
14h00 A Successful Case Study for NAM Development: Skin SensitizationNicoleKleinstreuer, NIH, NICEATM, United States (presentation: 25min; technical Q&A: 5min)
ThisDirectoratesession explains the history of NAMs and the work done to incorporate them into test guidelines. It aims to cover multiple approaches in vitro testing, in silico analyses, IATA, etc.
Philip Marx-Stoelting, German Federal Institute for Risk Assessment (BfR), Germany (presentation: 25min; technical Q&A: 5min)
Human Health Risk Assessment in the EU and the Potential to Develop New Approach Methodologies
11h30
Christopher Faßbender, PETA Science Consortium International (presentation: 25min; technical Q&A: 5min)
17h00 Discussion Session 1 and 2
Panel
Tea/Coffee break (16h00 16h30)
Moderator for both panels: Patience Browne, Principle Administrator to the OECD Pesticides Programme, OECD Environment Directorate Day 2 14 September 2022
Theme: Improvements to Test Guidelines for Non-target Organisms for Microbial Pesticide Testing Session 3: Regulatory Requirements for Non-target Organisms
Chair: Cozmina Link Vrabie, Board for the Authorization of Plant Protection Products and Biocides (Ctgb), The BuildNetherlandsoffprevious OECD Working Party on Pesticides (WPP) survey (2012), workshop (2013), and Expert Group on Biopesticides (EGBP) seminar (2018) on microbial guidelines and testing. These efforts identified more needs for improvement to non target hazard testing guidelines than for any others. The ultimate goal of this theme is to take a
Panellists: Nicole Kleinstreuer, Philip Marx Stoelting, David Allen, Valerie Fessard, Evangelos Daskalopoulos, Anna Lowit, Christopher Faßbender
Process to Develop Future NAMs for microbials / Other Test Guidelines: Aims to discuss government, industry, and other research possibilities based on outcome of previous session and funding needs. Identify possibilities for developing alternative testing methods decide on the selection of top 1 3 data requirements for initial efforts.
Panellists: Christopher Lythgo, Maria Trainer, Leah Zorrilla, José Carvalho
4 15h30 New in vitro methodologies that can be applied for the study of biopesticides’ hazard by the oral route
Valerie Fessard, French Agency for Food, Environmental and Occupational Health & Safety (Anses), France (presentation: 25min; technical Q&A: 5min)
Prioritization of Future Efforts: Aims to decide on the selection of top 1 3 data requirements for initial efforts.
16h30 Advancing reliable and relevant approaches for assessing pesticide products
Emily McVey, Board for the Authorization of Plant Protection Products and Biocides (Ctgb), The Netherlands (presentation: 25min; technical Q&A: 5min)
5 step forward from those efforts and discuss specific solutions to specific issues (e.g., test duration, appropriate toxicity measures, etc.).
Bilgin Karaoglan, German Environment Agency (Uba), Germany (presentation: 25min; technical Q&A: 5min)
Session 4: Current Ecological/Non-Target Test Guidelines Outlining the Issues
The following series of presentations will further discuss specific issues with ecological/non target organism hazard test guidelines that have been raised in previous EGBP workshops, seminars, etc., and any new issues. It will also discuss any resolutions or new developments with these issues since previous efforts and cover both terrestrial and aquatic studies
10h00 Where are we and where do we need to go? A Dutch perspective on the assessment of microbial pesticides
09h00
12h00 Testing Microbial Pesticides in Bees - Challenges and CurrentAbdulrahimAdvancementsAlkassab, Julius Kühn Institute, Germany (presentation: 25min; technical Q&A: 5min) Lunch break (12h30 14h00)
Emma Babij, Pest Management Regulatory Agency (PMRA), Canada (presentation: 25min; technical Q&A: 5min)
Chair: Emma Babij, Pest Management Regulatory Agency (PMRA), Canada
10h30 Regulatory Requirements for Non-target Organism Testing - GlobalRomaChallengesGywnn, Biorationale, United Kingdom (presentation: 25min; technical Q&A: 5min) Tea/Coffee Break (11h00 11h30)
Non-target Organism Testing with Microbial Pesticides in the US - Regulatory Requirements and Challenges
Geoff Sinclair, US Environmental Protection Agency (US EPA), United States (presentation: 25min; technical Q&A: 5min)
11h30 Aquatic Safety Studies with Microbial Pesticides retrospective analysis and recent advancements
09h30 Canadian Regulatory Requirements for Microbial Pesticide Non-target Organism Testing
6 14h00 Issues with Non-target Insect Testing with Microbial Pesticides - CRO perspectiveMarkWhittaker, APIS, United Kingdom (presentation: 25min; technical Q&A: 5min) 14h30 Issues with Aquatic Organism Testing with Microbial Pesticides - CRO perspectiveHenryKrueger, Eurofins, United States (presentation: 25min; technical Q&A: 5min) 15h00 Aquatic Testing with Non target Organisms and Microbial Pesticides Challenges and Potential Solutions Maria Herrero, Valent, United States (presentation: 25min; technical Q&A: 5min) Tea/Coffee break (15h30 16h00) 16h00 Adventures in Ecological Testing of Microbial Based AgriculturalLisaProductsOrtego, Bayer CropScience, United States (presentation: 25min; technical Q&A: 5min) 16h30 Panel Discussion Sessions 3 and 4 Panellists: Bilgin Karaoglan, Abdulrahim Alkassab, Mark Whittaker, Henry Krueger, Maria Herrero,OrtegoLisa Moderator: Shannon Borges, US Environmental Protection Agency (US EPA), United States Day 3 – 15 September 2022 Theme: Improvements to Test Guidelines for Non-target Organisms for Microbial Pesticide Testing (Cont.)
This session will identify any knowledge gained from CROs’ or researchers’ experience with microbial pesticides and/or test organisms that can help to begin addressing the issues (e.g., appropriate exposure duration, study duration, exposure routes, etc.). It will also highlight any areas of research that will inform revisions to guidelines and/or development of new guidelines.
Caroline Hauxwell, Queensland Univ. of Tech., Australia (presentation: 25min; technical Q&A: 5min) Tea/Coffee break (10h30 11h00)
Anne Steenbergh, Board for the Authorization of Plant Protection Products and Biocides (Ctgb), The Netherlands (presentation: 25min; technical Q&A: 5min)
7
14h00 Discussion Session 5a
10h00 Working with Invertebrate Pathogens in the Laboratory Considerations for Improving Non target Organism Testing
Prioritization of Future Efforts: Aims to decide on the selection of top 3 5 guidelines to focus on for future improvement and/or development efforts; alternatively, the planning committee could prioritize these guidelines to focus the agenda. Within those guidelines, identify specific questions or specific items that need to be addressed and summarize future research goals for each guideline.
9h30 Challenges in Testing with Microbes in Insects - Considerations for Test JohannesImprovementsJehle , Julius Kühn Institute, Germany (presentation: 25min; technical Q&A: 5min)
11h00 EU Guidance on the Assessment of Microbial Metabolites; Considerations for Non-target Testing
11h30 Environmental Risk Assessment of Entomopathogenic fungi - Considerations for Non-target Organism Testing Lara Reinbacher, Agroscope, Switzerland (presentation: 25min; technical Q&A: 5min) Lunch break (12h00 14h00)
Chair: Domenico Deserio, European Commission
Panel
Session 5: Current Ecological/Non-Target Test Guidelines – Addressing the Issues
Panellists: Johannes Jehle, Caroline Hauxwell, Anne Steenbergh, Lara Reinbacher Moderator: Domenico Deserio, European Commission Tea/Coffee break (15h30 16h00)
Funding: Goals of the session: For items that need further research: Discuss/decide on possibilities for carrying out this research (e.g., government, industry consortium, etc.) Determine what funding organizations to approach Determine what and who will be involved in developing the project and grant proposals Identify any other resource needs and develop a plan to address them, including lead people/organizations For items that can move forward without further research: Develop action plans for implementing recommendations Determine what organizations to approach and/or programs to utilize Identify lead people/organizations for carrying out this work
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8 16h00 Panel Discussion Session 5b Process to Update Current Test Guidelines: A short presentation on OECD TG programme will be provided. The ultimate goal of this discussion is to focus on developing & initiating efforts that would lead to improved test guidelines and/or guidance for microbial biopesticides, not rehash previous efforts. It will discuss government, industry and other research possibilities based on outcome of previous session and funding needs and identify other efforts to support improvement/development of guidelines and/or guidance (e.g., workgroup(s) within OECD WPP EGBP that focus on specific guidelines). It will finally review and identify processes (e.g., OCSPP, OECD test guideline programs or combination) through which improvements to guidelines or development of guidance can be made and identify the advantages associated with the various paths
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Moderator: Anne Gourmelon, Principle Administrator to the OECD Test Guidelines Programme, OECD Environment Directorate Day 4 – 16 September Action
2022 Theme: Develop
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Geoff Sinclair, Emma Babij, Emily McVey, Roma Gywnn,
Moderators: Shannon Borges, US Environmental Protection Agency (US EPA), United States Eric Liegeois, European Commission Tea/Coffee break (11h00 11h30)
Plans to Implement Recommendations 09h30 Open ActionDiscussionPlansand
9 11h30 Open Discussion (cont.) 12h30 Conference Results and next Steps Organising Committee 12h45 Wrap-Up and Leaving Address by the CRP Lieve Herman, CPR Scientific Advisory Body 13h00 Conference closes
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