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Environmental Risk Assessment Workshop: Non-Target Organism Testing

    June 26, 2023-June 30, 2023
    8:00 am - 5:00 pm
    Gateway Hotel & Conference Center
    Ames, Iowa, USA

Supported by a grant from the United States Department of Agriculture (USDA) Foreign Agricultural Service (FAS) Emerging Markets Program (EMP), this five-day technical training workshop on non-target organism testing of transgenic crops was organized by the Agriculture & Food Systems Institute, in cooperation with the USDA Agricultural Research Service, Iowa State University, and Corteva Agriscience. The purpose of this activity was to provide regulatory scientists and environmental risk assessors with an experiential learning opportunity in laboratory and field testing of non-target organisms.

Using laboratory facilities provided by Iowa State University, the workshop participants gained experience setting up bioassays to assess the impacts of insect-resistant corn on corn earworm, the target pest, and on ladybird beetles, a beneficial non-target species. Participants also evaluated the bioassays, collected and compiled their data, and received feedback on their conclusions.

As part of this training,

  • Participants learned how insect populations are assessed in agroecosystems using two common insect collection techniques: sticky cards to collect flying insects and pitfall traps to collect ground-dwelling insects.
  • Participants gained first-hand experience setting up traps in established fields of insect-resistant and conventional corn.
  • Participants were given the opportunity to review and critique data generated by commercial laboratories, which are typically provided to government regulators in support of applications to authorize commercial planting of insect-resistant crops.

Agenda

Day 1

Monday | June 26, 2023 | 08:00 – 20:00

Time Activity/Presentation Lead
Session I: Welcome and Introductions
08:30 Welcome Remarks Dr. Steve Harris
Chair, Department of Plant Pathology, Entomology & Microbiology, Iowa State University, Ames, Iowa, USA
08:35 Overview of Facilities at Iowa State University Dr. Tom Sappington
Research Entomologist, Corn Insects and Crop Genetics Research Unit, USDA – Agricultural Research Service, Ames, Iowa, USA
  Dr. Richard Hellmich (retired)
Lead Scientist and Research Entomologist (former), Corn Insects and Crop Genetics Research Unit, USDA – Agricultural Research Service, Ames, Iowa, USA
08:45 Introduction of Participants and Resource People  Dr. Bhavneet Bajaj
Manager, Scientific Programs, Agriculture & Food Systems Institute, Washington, DC, USA
Overview of the Workshop  
Session II: Laboratory Bioassay Setup 
09:15 Introduction to Test Organisms and Bioassay Protocols Dr. Chad Boeckman
Global Regulatory Lead (Oilseeds), Corteva Agriscience, Johnston, Iowa, USA
09:45 Coffee Break
10:00 Set Up Bioassays Groups
11:45 Lab Bioassay Review Ms. Kristine LeRoy
Lead, Ecotoxicology and Safety Assessment Laboratory, Corteva Agriscience, Johnston, Iowa, USA
12:00 Lunch
Session III: Environmental Risk Assessment (ERA) for Genetically Engineered (GE) Plants
13:00 Introduction to ERA Dr. Andrew Roberts
Chief Executive Officer, Agriculture & Food Systems Institute, Washington, DC, USA
15:00 Coffee Break
Session IV: Tiered Testing for ERA 
15:15 Introduction to Tiered Testing:
Early Tier, Semi-Field, and
Field Testing
Dr. Jörg Romeis
Head, Biosafety Research Group, Agroscope, Zurich, Switzerland
  and Dr. Richard Hellmich
16:00 Introduction to Non-Target
Field Studies
Dr. Richard Hellmich
16:45 Recap of the Day & Overview of Tomorrow’s Agenda Dr. Andrew Roberts

 

Day 2

Tuesday | June 27, 2023 | 08:00 – 17:00

Time Activity/Presentation Lead
Session V: Field Survey Setup
08:15 Questions from Day 1 & Review of Agenda for Day 2 Dr. Andrew Roberts
08:30 Introduction to Field Techniques Dr. Richard Hellmich
09:15 Set Up Sticky Traps and Pitfall Traps Groups
11:30 Lunch  
13:00 Tour of FEEL Center ISU Extension Staff
Session VI: Planning and Designing NTO Studies
14:30 Selection of Surrogate Species and Life Stages Dr. Jörg Romeis
15:15 Lab Test Design & Introduction to Workbook Exercises  Dr. Chad Boeckman
15:45 Coffee Break  
16:15 Workbook Exercise: (1) Study Evaluation – Apis mellifera and (2) Study Evaluation – ladybird beetles Dr. Chad Boeckman
16:45 Recap of the Day, Q&A, and Overview of Tomorrow’s Agenda Dr. Andrew Roberts

 

Day 3

Wednesday | June 28, 2023 | 08:00 – 17:00

Time Activity/Presentation Lead
08:30 Questions from Day 2 & Review of Agenda for Day 3 Dr. Andrew Roberts
Session VII: Interpreting Study Reports
08:45 Introduction to Test Report Evaluation Dr. Chad Boeckman
09:00 Group Work on NTO Test Report Evaluation Groups
12:00 Working Lunch  
13:00 Report Out from Each Group and Group Q&A Groups
14:00 Break  
Session VIII: The Limits of NTO Testing
14:30 Early-Tier NTO Testing in Environmental Risk Assessment Dr. Jörg Romeis
15:15 Making Sure Your Tests Are Useful: Get the Data You Need Dr. Andrew Roberts
Session IX: Field Test Data Collection and Interpretation
15:45 Introduction to Field Organisms and Identification Dr. Richard Hellmich
16:30 Recap of the Day, Q&A, and Overview of Tomorrow’s Agenda Dr. Bhavneet Bajaj

 

Day 4

Thursday | June 29, 2023 | 08:00 – 21:00

Time Activity/Presentation Lead
Session X: Collection and Processing of Field Data
08:15 Collect Sticky Traps and Pitfall Traps Groups
09:45 Coffee Break
10:00 Processing Samples from Pitfall Traps Dr. Royce J. Bitzer
10:30 Process Samples, Identify Samples, Post Results, and Compare Groups
12:00 Lunch  
Session XI: Lab and Field Tour of Corteva Agriscience
13:30 Laboratory and Field Tour of Corteva Agriscience Groups
16:00 Recap of the Day, Q&A, and Overview of Tomorrow’s Agenda Dr. Andrew Roberts

 

Day 5

Friday | June 30, 2023 | 07:45 – 17:00

Time Activity/Presentation Lead
08:00 Questions from Day 4 & Review of Agenda for Day 5 Dr. Andrew Roberts
Session XII: Collection and Analysis of Laboratory Bioassay Data
08:15 Data Collection from the Lab Bioassays Dr. Chad Boeckman
08:45 Lab Study Evaluation (Scoring the Test Set Up on Day 1) Groups
10:00 Coffee Break
11:00 Group Discussion: (1) Comparison of Bioassay Results and (2) Data Interpretation Dr. Chad Boeckman 

or 

Dr. Richard Hellmich

12:00 Lunch  
Session XIII: Wrap Up and Participant Feedback
13:00 Insect Resistance Management and Other Tabled Issues Dr. Richard Hellmich
14:00 Data Transportability Dr. Andrew Roberts and Dr. Jörg Romeis
14:25 Coffee Break  
14:30 Participant Feedback & Post-Event Survey  Dr. Bhavneet Bajaj
16:00 Recap of the Week & Acknowledgments Dr. Andrew Roberts
16:30 Close of Workshop  

 

Speakers and Organizers

Dr. Bhavneet Bajaj

Agriculture & Food Systems Institute, USA

Dr. Bhavneet Bajaj joined the Agriculture & Food Systems Institute (AFSI) in July 2018 as Scientific Program Manager. She has been involved in projects related to safety assessment of foods and feeds derived from genetically engineered plants and serves as a resource person in providing technical support for capacity building programs in biotechnology. She was also the program lead for USDA-funded technical training for Chinese and Indonesian regulators and manages operations for both the Crop Composition Database and the World Nutrient Databases for Dietary Studies.

Prior to joining AFSI, Dr. Bajaj was a Visiting Scientist at the Sustainable Agricultural Systems Laboratory, Agricultural Research Service, USDA, where she worked on carotenoid pathway regulation in tomatoes. Before then, she was Associate Investigator with the Plant Protection group at (then) DuPont, where she devised a metabolic engineering strategy for insect control in soybean. While in India, she was an Assistant Professor at Jaipur National University, where she taught genetic engineering, enzymology, and biochemistry courses to M.Sc. level students. Her research work over the past 12 years involved plant secondary metabolites of nutritional, agricultural, and medicinal importance.

Dr. Harit Kaur Bal

Bayer Crop Science

Dr. Harit Kaur Bal is a Senior Research Entomologist in the Ecological Risk Assessment Team in Regulatory Sciences at Bayer Crop Science in Chesterfield, MO, a role she has held since 2018. She is responsible for developing and implementing global ecological risk assessment strategies for biotechnology-derived crop products to enable successful product launches and defense. Harit serves as a Study Director for field non-target arthropod studies in the U.S. and provides technical support on these studies globally. She also monitors laboratory studies for non-target arthropod assessment of biotechnology-derived insect control products to support the ecological risk assessment of these products.

Harit has a Ph.D. in Entomology from Ohio State University, an M.Sc. in Entomology, and B.Sc. in Agriculture (Hons.) from Punjab Agricultural University, India. Following her Ph.D., Harit did post-doctoral research at Ohio State University and Michigan State University. She lives in Lake St. Louis, MO, with her husband and two daughters (9 and 4), and outside of work, she enjoys spending time with her kids, dancing, watching Indian classic movies, eating, and working out.

Dr. Royce J. Bitzer

Corn Insects and Crop Genetics Research Unit, USDA-ARS and Department of Entomology, Iowa State University

Dr. Bitzer was a research associate with the Iowa State University Department of Entomology from 1997-2004 and 2006-2010. He joined the USDA-ARS Corn Insects and Crop Genetics Research Unit in 2011 and stayed until 2020. He has studied the effects of transgenic corn and soybeans on non-target ground-inhabiting insects, especially Collembola and carabid beetles. Since June 2021, he has been working in cooperation with Bayer CropScience on another project about the effects of transgenic coleopteran Bt corn on carabid and staphylinid beetles.

He received his B.S. (1980) in biology and his Ph.D. (1995) in ecology and evolutionary biology from Iowa State University. Besides his research on non-target arthropods in agricultural fields, he also studied the ecology of cerambycid and carrion beetles and the territorial behavior and migration of red admiral butterflies (Vanessa atalanta). He has maintained the online Red Admiral and Painted Lady Research Site since 1997 and started the associated Vanessa Migration Project (https://vanessa.ent.iastate.edu) in 2001 to monitor continent-wide butterfly distribution and migratory patterns through citizen science observations. He has also done life-history and migration studies of Monarch butterflies (Danaus plexippus).

Dr. Chad Boeckman

Corteva Agriscience

Chad Boeckman received both his M.S. and Ph.D. from Oklahoma State University, where his research focused on characterizing the environmental effects of point and non-point source contaminants and understanding the ecosystem effects of invasive species in a wide array of different aquatic habitats. He joined Corteva Agriscience in May 2011 and led the Ecotoxicology and Safety Assessment Laboratory in Global Regulatory Science for ten years, focusing on characterizing the environmental safety of genetically modified crops. Chad now serves as the Global Regulatory Leader for Oilseeds, where he focuses on all aspects of GM crop characterization in the pursuit of bringing these products to market. He is also heavily engaged in Monarch butterfly and pollinator conservation, along with other sustainability efforts for Corteva at both the state and national levels.

Ms. Stephanie Carter

Agriculture & Food Systems Institute

Stephanie manages the day-to-day operations at AFSI’s headquarters in Washington, DC, serving as the main point of contact for financial and contractual matters and ensuring that budgets and critical deadlines are met. She also plans, coordinates, and executes in-person meetings and related activities associated with AFSI’s international programmatic work. Stephanie has over 30 years of experience with the organization, having joined the team as Administrative Coordinator for the Risk Science Institute (RSI) in October 1986.

After RSI became part of the Research Foundation, Stephanie was promoted to Senior Program and Conference Manager in 2000, and she has been involved in the development, planning, and management of international conferences, workshops, and training programs ever since. She also managed the TAKE 10! Program and did teacher training and school outreach to help promote physical activity and health in elementary schools. After the Research Foundation became the Agriculture & Food Systems Institute in 2020, Stephanie’s role was expanded to Manager of Operations and Logistics. She was promoted to Senior Manager in 2023.

Ms. Mattie Gose

Bayer Crop Science

Mattie is part of the Environmental Risk Assessment team with Bayer Crop Science. She is a member of a non-target tier 4 study where she has conducted fieldwork using various arthropod collection methods, including pitfall, sticky traps, rootball samples, visual counts, and sentinel prey stations. She has enumerated and identified taxa from sticky traps, where she has focused on parasitic Hymenoptera, Coleoptera, Diptera, and pest species. 

Mattie received her B.S. from Iowa State University in animal ecology along with a minor in entomology. During her time at Iowa State, she worked at Reiman Gardens and the Iowa State Insect Zoo, where she became skilled in insect husbandry and science communication. She will continue her aspirations in August by attending graduate school at the University of Iowa, where she will study parasitic insect ecology. 

Mr. Jordan Grandy

Agriculture & Food Systems Institute

Jordan provides core support across all of the Agriculture & Food Systems Institute’s research, logistics, and events. He has experience in finance and trade services, academia, and public-private partnerships, as a researcher, data analyst, and consultant. He joined the AFSI team in May 2023 as Program Assistant and provides administrative support to scientific and support staff, including grant management, scheduling of internal and external meetings, and preparation of written materials. He also assists in organizing, supporting, and executing events, workshops, and conferences.

Jordan holds an M.A. in International Affairs, concentrating in International Public Policy, from Pennsylvania State University, and a B.A. in International Affairs and Sociology, with a minor in Political Science from the University of Cincinnati.

Dr. Richard Hellmich

Corn Insects and Crop Genetics Research Unit, USDA–ARS (former)

Richard Hellmich retired in 2022 after 43 years of research experience in entomology. He was a Lead Scientist and Research Entomologist at the USDA–ARS, Corn Insects and Crop Genetics Research Unit in Ames, Iowa. Dr. Hellmich focused his research on European corn borer ecology and genetics, insect resistance management, non-target effects of genetically engineered maize, and habitat restoration for monarch butterflies. Prior to his work in Ames, he studied Africanized honey bees at the USDA–ARS Honey Bee Laboratory in Baton Rouge, Louisiana.  Dr. Hellmich was honored as Scientist of the Year for the Agricultural Research Service, Midwest Area  in 2002 and was elected Fellow of the Entomological Society of America in 2020.

Ms. Kristine LeRoy

Corteva Agriscience

Kristine Leroy received a B.S. from Iowa State University (ISU) in biochemistry. While attending ISU, she worked for the USDA-ARS Corn Insect Research Unit, which cemented her interest in agronomic pests and control.  She joined Corteva Agriscience in June 2009 as a member of the Ecotoxicology and Safety Assessment Laboratory in Seeds Regulatory Science. Her initial responsibilities ranged from bioassay development and study execution with pest species and non-target organisms, as well as overall lab duties. In the last year and a half, she transitioned to leading the Ecotoxicology and Safety Assessment Laboratory, a talented and diverse team focused on characterizing the environmental safety of genetically modified crops.  

Mr. Alexander Mullins

Bayer Crop Science

Alex Mullins has been a Biologist on the Ecological Risk Assessment Team at Bayer Crop Science since 2021. In this role, Alex is responsible for generating data to conduct Tier IV Ecological Risk Assessment of biotechnologically derived insect control products for non-target arthropods in maize. Alex earned his M.S. in Ecology and Evolutionary Biology from Iowa State University, where his research focused on the oviposition and resource-seeking behavior of non-migrant Monarch butterflies to inform landscape-level conservation efforts. Alex earned his B.S. in Wildlife Biology from Adams State University and concurrently worked for the Bureau of Land Management, San Luis Valley Field Office, where he supported Wildlife Biologists by managing habitat and conducting wildlife surveys for threatened and endangered species on public lands.

Dr. Andrew Roberts

Agriculture & Food Systems Institute

Dr. Andrew Roberts joined the Agriculture & Food Systems Institute (AFSI) in December 2009 as the Deputy Director of the Center for Environmental Risk Assessment (CERA), where he developed tools and materials for use in training and capacity building related to the problem formulation approach to environmental risk assessment and served as the coordinator for CERA’s capacity building projects under the USAID-funded South Asia Biosafety Program (SABP) and the World Bank-funded Partnership for Biosafety Risk Assessment and Regulation, in Bangladesh, Pakistan, and Vietnam. He also provided technical support for capacity building work in Brazil, India, Japan, Chile, and South Africa. In January 2015, he became the director of CERA, as well as the Center for Safety Assessment of Food and Feed (CSAFF), which worked on food and feed safety assessment for foods derived from genetically engineered plants. The two centers were later consolidated under the Research Foundation, for which he became Deputy Executive Director in January 2017. When the organization became the Agriculture & Food Systems Institute in 2020, his title shifted to Vice President – Biotechnology, and he assumed the role of Chief Executive Officer later that year.

Prior to joining AFSI, Dr. Roberts worked at the U.S. Department of Agriculture (USDA) in several different capacities, all related to the regulation of agricultural biotechnology. He began his career at USDA as an AAAS Risk Policy Fellow in the Office of Science of Biotechnology Regulatory Services (BRS), the group responsible for regulating genetically engineered plants at USDA’s Animal Plant Health Inspection Service. After spending a year in the New Technologies office of the Foreign Agricultural Service serving as the lead for USDA’s efforts related to the Cartagena Protocol on Biosafety, he returned to BRS to serve in the International Affairs branch where he remained until joining AFSI.

Dr. Jörg Romeis

Agroscope

Jörg Romeis is the head of the Biosafety Group at Agroscope in Zurich, Switzerland. Agroscope is the Swiss center of excellence for agricultural research and is affiliated with the Federal Office for Agriculture. He has an M.Sc. in biology and has been trained as an applied entomologist with a focus on biological control and multi-trophic interactions. He has more than 20 years of experience in non-target risk assessment of transgenic crops and the design and execution of non-target laboratory studies in particular. Besides research projects to investigate non-target impacts of selected transgenic plants and insecticidal compounds, he has also been actively involved in developing testing protocols and guidelines for non-target risk assessment. In 2023, he became the president of the International Society for Biosafety Research (ISBR), which aims to promote scientifically sound research that supports biosafety assessment.

Dr. Tom Sappington

Corn Insects and Crop Genetics Research Unit, USDA–ARS and Department of Plant Pathology, Entomology & Microbiology, Iowa State University

Tom Sappington is a Research Entomologist in the Corn Insects and Crop Genetics Research Unit, USDA–ARS, in Ames, Iowa. He is also an Affiliate Professor and member of the graduate faculty in the Department of Plant Pathology, Entomology & Microbiology at Iowa State University. He received his Ph.D. in Systematics & Ecology (University of Kansas, 1989), and his formal training is as an insect ecologist. In Ames, he mainly studies the ecology, behavior, management, and population genetics of European corn borer, Ostrinia nubilalis, and western corn rootworm, Diabrotica virgifera virgifera. Before transferring to Iowa in 2003, he served as Lead Scientist of the ARS cotton insects project for four years in Weslaco, Texas, where he conducted research mainly on boll weevil, Anthonomus grandis. Most of his current research is focused on insect movement as it affects agriculture, including in the context of insect resistance management. He conceived, co-organized, and led the international Diabrotica Genetics Consortium 2003-2016 and has served as North American Co-convenor of IWGO (International Working Group on Ostrinia and other maize pests) for the last 12 years. He served as Subject Editor for Environmental Entomology for 16 years and has published over 140 peer-reviewed papers.

Ms. Layla Tarar

Agriculture & Food Systems Institute

Layla creates, implements, and oversees AFSI’s communication and digital learning strategies and is continuously working to improve the distribution and impact of the institute’s scientific program outputs. Working closely with her colleagues, she develops and executes a cohesive outreach strategy using video, print, and online methods, including but not limited to the organization’s website, newsletter, and social media platform. She is also responsible for developing, managing, and advancing AFSI’s e-learning program, as well as working with scientific and operations staff to plan and conduct online trainings, workshops, and webinars.

Layla joined the AFSI team in August 2017 as a Communications Associate. She was promoted to Communications Manager in September 2018 and was heavily involved in the organization’s renaming and rebranding. Her role was expanded to Manager of Communications & Digital Learning after the organization became the Agriculture & Food Systems Institute in 2020.

Prior to joining AFSI, Layla worked in Rome as Editor and Web Content Administrator at the School of European Political Economy, LUISS University. Before moving to Italy, she spent a year in Pakistan working as Community Liaison Office Coordinator at the U.S. Consulate in Karachi, which was preceded by two years in the United Arab Emirates, working as Management Assistant at the U.S. Embassy in Abu Dhabi. She has a B.A. in Biology and International Relations from Boston University and is fluent in English, Italian, and Thai.