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Objective

Food safety is recognized as a universal public health concern. Enormous economic and human resources are invested globally to ensure that there is a safe food supply. However, most of these resources are focused on improving food safety through the reduction of harm from chemical and microbial contaminants present in foods, rather than on the safety of the foods themselves. The ILSI Research Foundation addresses this challenge by providing information resources and capacity building activities for scientists, regulators, and the public, focusing particularly on the safety assessment of foods and feeds derived from GE plants.

Collaborators & Partners

USDA Foreign Agricultural Service, CropLife International, CropLife China, ILSI Focal Point in China, China Center for Disease Control and Prevention (CDC), Chinese Society of Agricultural Biotechnology, Chinese National Institute for Nutrition and Health, and Estel Consult Ltd.

Current Activity

The ILSI Research Foundation's concluded projects in the area of food and feed safety assessment include:

GE Food Safety Capacity Building

Understanding the need for technical capacity building for food safety assessment, the ILSI Research Foundation shares its knowledge and scientific expertise by facilitating regional workshops and developing and disseminating reference materials.

Crop Composition Database

The ILSI Research Foundation’s CCDB is a curated, open resource that provides data on the natural variability in the nutritional composition (e.g., nutrients, anti-nutrients, and secondary metabolites) of key crop species.

Past Work

The ILSI Research Foundation's concluded projects in the area of food and feed safety assessment include:

Resources

Newsletters

Find out about the work we are doing by reading our monthly newsletter.

Safety Assessment of Foods and Feeds Derived from Genetically Engineered Plants: Phase II Technical Workshop

Washington, DC and Ashland, OH, USA

Implemented by the ILSI Research Foundation, this technical training program is structured to provide Chinese public-sector scientists in-depth technical information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from genetically engineered (GE) crops.

Read more

OECD Working Group on the Safety of Novel Foods and Feeds

Paris, France

The OECD Task Force on the Safety of Novel Foods and Feeds, for which the ILSI Research Foundation is a recognized observer organization, works on technical issues related to the food safety of novel foods and feeds, including the products of agricultural biotechnology.

Read more

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By Invitation Only. 

The ILSI Research Foundation, in collaboration with ILSI Focal Point in China, conducted the first phase of our Technical Training Program on Safety Assessment of Foods and Feeds Derived from Genetically Engineered (GE) Plants on March 5-7, 2019 in Langfang, China. Aimed at providing Chinese public-sector scientists with in-depth information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from GE crops, Phase I of the program established a baseline understanding of the food safety assessment paradigm, toxicity and allergenicity testing, compositional assessment, and animal testing.

Phase II of the technical training, comprised of laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted, is scheduled to take place on July 17-21, 2019 in Washington, DC and Ashland, OH, USA. The training includes a review of the concepts from Phase I, with an additional focus on critical reading and review of study reports.

Participants are asked to complete the eLearning module “Application of Problem Formulation for Food and Feed Safety Assessment” in advance of the Phase II workshop.

Agenda

Day 1

Day 2

Day 3

Day 4

Day 5

Day 1

ILSI Research Foundation · Washington, DC
Monday, June 17, 2019 · 09:30-16:30
Welcome, Introduction, and Overview of the Workshop
Dr. Bhavneet Bajaj, ILSI Research Foundation Recap of Phase I: Basic Concepts in the Safety Assessment of Novel Foods and Feeds, Problem Formulation Methodology, and Guidelines and Methods
Dr. Mònica García-Alonso, Estel Consult, Ltd. Review of eLearning Modules
Dr. Mònica García-Alonso, Estel Consult, Ltd. FDA Regulation of Food from New Plant Varieties: An Overview
Dr. Patrick Cournoyer, US Food & Drug Administration EPA Regulation of Plant-Incorporated Protectants
Dr. Chris A. Wozniak, US Environmental Protection Agency

Day 2

ILSI Research Foundation · Washington, DC
Tuesday, June 18, 2019 · 08:30-16:00
Understanding the American Public’s Perceptions of Genetically Modified Food
Dr. Cara L. Cuite, Rutgers University Public Opinion on GE Plants and Food and Feed Derived from Them: China
Dr. Xenia Morin, Rutgers University Breakout Groups: Exercise 1 - Risk Communication Group Discussion and Q&A on Public Perception and Communication
Dr. Xenia Morin, Rutgers University New Plant Breeding Techniques: Global Status of Regulation of Products for Food and Feed Use
Dr. Bhavneet Bajaj, ILSI Research Foundation Breakout Groups: Exercise 2 -Safety Assessment of Provided Case Studies (Case 1: Cry1Ac, Case 2: IPD072Aa), Group Presentations, and Discussion
Dr. Mònica García-Alonso, Estel Consult, Ltd.

Day 3

Charles River Laboratories · Ashland, OH
Wednesday, June 19, 2019 · 08:30-17:30
Introduction to CRL and Rules
Leanne Silvis, Charles River Laboratories Animal Welfare, Human Health, and Safety Considerations for Animal Testing Facilities
Leanne Silvis, Charles River Laboratories Acute Oral Toxicity Studies - (a) Design, Guidelines, and Doses, (b) Surrogate Species, (c) Interpreting Results and Writing Reports
Dr. Jason Roper, Corteva Agrisciences Breakout Groups Exercise 3: Critical Review of Acute Oral Toxicity Studies Data, Group Presentations, and Discussion
Dr. Mònica García-Alonso, Estel Consult, Ltd. Discussion and Q&A
Dr. Jason Roper, Corteva Agriscience Quality Assurance & Good Laboratory Practices
Ms. Carrie James and Mr. Kelvin Mentzer, Charles River Laboratories Role of a Study Director
Dr. JoAnna Bultman, Charles River Laboratories

 

Biosecurity, Laboratory, and Vivarium Safety
Leanne Silvis, Charles River Laboratories

CRL Facility Tour

Day 4

Charles River Laboratories · Ashland, OH
Thursday, June 20, 2019 · 08:30-17:00
Presentation on Pathology
Dr. Gary Coleman, Charles River Laboratories CRL In-Depth Facility Tour and Demonstration
Ms. Susana Rodriguez, Mr. William Miller, and Mr. Matthew Bennett, Charles River Laboratories
  • Histology
  • Necropsy
  • Neurobehavioral Testing Suite
  • Inlife Dosing and Blood Collection Demonstration
90-Day Sub-Chronic Studies
Dr. Jason Roper, Corteva Agriscience Breakout Groups: Exercise 4 - Critical Review of 90-Day Feeding Studies Data, Group Presentations, and Discussion
Dr. Jason Roper, Corteva Agriscience

Discussion and Q&A

Day 5

Charles River Laboratories · Ashland, OH
Friday, June 21, 2019 · 08:30-14:30
Bringing It All Together: Writing Relevant and Informative Risk Assessment Summaries
Dr. Mònica García-Alonso, Estel Consult, Ltd. RNAi Food and Feed Safety Assessment
Dr. Xu Hu and Dr. Jason Roper, Corteva Agriscience Investigation of an In Vitro Method for Protein Hazard Characterization
Dr. Jason Roper, Corteva Agriscience

Presentation of Completion Certificates and Workshop Closure

Speakers

Dr. Bhavneet Bajaj, ILSI Research Foundation

Dr. Bhavneet Bajaj joined the ILSI Research Foundation as Scientific Program Manager in July 2018. She has worked in academia, the biotechnology industry, and the US Department of Agriculture (USDA) and has a combined research and teaching experience of 12 years.

Dr. Bajaj has worked on plant secondary metabolites of nutritional, agricultural, and medicinal importance. Prior to joining the ILSI Research Foundation, Dr. Bajaj held the position of Visiting Scientist at the Sustainable Agricultural Systems Laboratory, Agricultural Research Service, USDA, where she worked on carotenoid pathway regulation in high polyamine containing tomatoes. Before then, she was an Associate Investigator with the Plant Protection Group at DuPont, where she worked on metabolic engineering as a strategy for insect control in soybean. During her postdoctoral training, she worked on targeted metabolite profiling of triterpene glycosides and phenolic acids in cell suspensions of black cohosh and developed an in vitro protocol for accelerating its seed germination. Dr. Bajaj has also worked as an Assistant Professor at Jaipur National University, India, where she taught genetic engineering, enzymology, and biochemistry courses to masters level students.

Dr. Bajaj received her M.Sc. and Ph.D. in Biotechnology from Guru Jambheshwar University of Science and Technology, India. Her graduate level research comprised of genetic diversity studies on bacterial blight pathogen of clusterbean using molecular markers.

Dr. Patrick Cournoyer, US Food and Drug Administration

Dr. Patrick Cournoyer is a regulatory scientist in the US Food and Drug Administration’s Office of Food Additive Safety. He helps administer the Plant Biotechnology Consultation Program, which works with plant biotechnology developers to help them ensure the safety of food from new plant varieties prior to marketing. He joined the Federal Government as a class of 2013 Presidential Management Fellow. Patrick received his Ph.D. from Yale University in 2013, where he studied the cell biology of the plant immune system. Prior to graduate school, Patrick worked for the science communication company Genius GmbH in Germany, where he helped develop EU-funded websites to inform consumers about the safety and regulation of genetically engineered plants. Patrick completed a Bachelor of Science in plant science and German studies at McGill University in Montreal, Canada in 2005.

Dr. Cara Cuite, Rutgers University

Dr. Cara Cuite is an Assistant Extension Specialist in the Department of Human Ecology at Rutgers University. Dr. Cuite is a health psychologist who studies community food security, risk communication, and public perceptions of food-related issues, including food safety and genetically engineered foods. More recent projects have focused on communicating about weather-related emergencies as well as interventions to reduce household food, energy, and water use. Her work has been funded by the National Science Foundation, the United States Department of Agriculture, the National Center for Food Protection and Defense, New Jersey Sea Grant, and Johnson & Johnson. She received her Ph.D. in Psychology from Rutgers University and a B.S. in Psychology and Modern Languages from Union College.

Dr. Mònica García-Alonso, Estel Consult, Ltd.

Dr. Mònica García-Alonso is an independent consultant and director at Estel Consult, Ltd. She has been working in the area of risk assessment of genetically modified crops and regulatory affairs for more than 20 years. She holds a bachelor’s degree in biology, with a specialty in zoology and entomology, and a master’s degree in insect physiology and ecology from the University of Barcelona, as well as a doctorate in neurobiology from the University of Reading. She worked for Syngenta for 19 years and set up her own consultancy eight years ago. She now supports private and public research activities aimed at developing GM crop solutions and provides training on risk assessment to regulators and developers around the world.

Dr. Xu Hu, Corteva Agrisciences

Dr. Xu Hu received his B.S. in Plant Protection from Henan Agricultural College, China in 1982. He earned his M.S. in Plant Pathology in 1985 and then worked as a research associate for three years at Institute of Plant Protection, Chinese Academy of Agricultural Science (CAAS), Beijing, China.  He completed his Ph.D. in Molecular Biology and Genetics at the University of Guelph, Canada in 1994.

From 1994 to 1998, Dr. Xu Hu conducted postdoctoral research in Colorado State University, working on the expression of antifungal protein genes in transgenic potato plants and on the improvement of seed oil content in Brassica napus at the Plant Biotechnology Institute, National Research Council of Canada. Xu joined Pioneer in 1998 as a discovery post-doc for molecular characterization of Sclerotinia resistance in transgenic sunflower plant, and then as a senior research associate for the generation of novel resistance against soybean cyst nematode (SCN). As a principal research scientist, Xu led a team working on transgenic resistance to soybean fungal diseases and contributed in RNAi studies on SCN and corn rootworm control. In 2011, Xu took the role of corn rootworm RNAi project leader where he collaborated across functions to progress the RNAi technology through the trait development pipeline. Following the merger of DOW with DuPont in 2017, Xu briefly worked corn diseases and transitioned to input trait discovery, Corteva Agrisciences in 2019, working on genomics-based insecticidal discovery.

Dr. Xenia Morin, Rutgers University

Dr. Xenia Morin is the Senior Associate Dean for Learning, the Undergraduate Program Director for the Agriculture and Food Systems Program, and an Associate Teaching Professor in the Department of Plant Biology at the School of Environmental and Biological Sciences, Rutgers University. Dr. Morin works and collaborates at the intersection of science, social science, and society, and she participates in tackling the formidable challenge of feeding our growing population. As a trained plant biochemist, her research and teaching has grown increasingly interdisciplinary over the years and she now focuses on agriculture and food systems. She has studied, researched, published, and taught on the topic of genetically modified food since 2001 at Bryn Mawr College, Princeton University, and now at Rutgers University.

Dr. Jason Roper, Corteva Agrisciences

Dr. Jason Roper earned his B.S. in Biomedical Science with a minor in Chemistry from Western Michigan University in 1997. He then completed his M.S. and Ph.D. in Molecular Toxicology and Environmental Medicine at the University of Rochester School of Medicine and Dentistry in 2004 and 2005, respectively. Following his post-graduate studies, Jason worked for six years as Senior Toxicologist and Study Director at a contract research organization specializing in GLP mammalian toxicology studies. He joined DuPont Pioneer in 2011 as Research Scientist and Toxicologist, managing a team of scientists responsible for the planning and execution of mammalian, livestock, and avian toxicology studies to support product safety evaluations for global regulatory submissions of genetically modified organisms (GMOs), including insect-resistant and herbicide-tolerant maize, soybean, rice, and canola products.

Jason joined the DuPont Central Research and Development (CR&D) group at Haskell Global Centers for Health and Environmental Sciences in 2013 as Principal Investigator and Senior Research Toxicologist, providing consulting services for the several DuPont businesses in the agricultural, biotechnology, and food industries. Following the merger of DOW with DuPont in 2017, Jason led the general, neuro- and inhalation toxicology competencies at Haskell Global Centers until transitioning to the Corteva Agrisciences (a division of DowDuPont) seeds business in 2019, as a subject-matter expert for regulatory toxicology and product safety. Jason has served as Chair of the CropLife International Toxicology Expert Team (2016-2018) and the DuPont Agricultural Animal Resource Committee (2016-present), Vice-Chair of the Haskell Animal Welfare Committee (2013-2017), and is a member of the HESI Protein Allergen, Toxin, and Bioinformatics (PATB) group and the Haskell Contract Laboratory Evaluation and Approval Team (2015-present).

Dr. Chris A. Wozniak, US Environmental Protection Agency

Dr. Chris A. Wozniak received his training in Plant Pathology and Life Sciences at the University of Nebraska at Lincoln, where his research efforts focused on understanding cell differentiation and morphogenesis in Sorghum bicolor. As a post-doctoral associate, Chris then worked to develop insect resistant cotton and to develop protocols for genetic transformation of sugarbeet. He subsequently joined the USDA-ARS full time to study the biological control of an insect pest in sugarbeet.

After 18 years in plant science research, Chris entered the world of regulatory science at the US Environmental Protection Agency (US EPA), Office of Pesticide Programs as a risk assessor and human health specialist. At EPA, Chris performed risk assessments of microbial and plant-based pesticides, particularly in the areas of human health and environmental consequences of gene flow.

As a Biotechnology Special Assistant in the Office of Pesticide Programs at US EPA, Dr. Wozniak focuses on issues of biotechnology policy, interagency coordination of biotech regulation, and environmental risk assessment of plant-incorporated protectants and sterility mechanisms in mosquitoes.

Group Photo of Phase I & II Participants and Key Faculty (Langfang, China,  March 5, 2019) Group Photo of Phase I & II Participants and Key Faculty (Langfang, China, March 5, 2019) [post_title] => Safety Assessment of Foods and Feeds Derived from Genetically Engineered Plants: Phase II Technical Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => china-phase2 [to_ping] => [pinged] => [post_modified] => 2019-06-10 15:43:27 [post_modified_gmt] => 2019-06-10 15:43:27 [post_content_filtered] => [post_parent] => 0 [guid] => https://ilsirf.org/?post_type=event&p=10928 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 8650 [post_author] => 65 [post_date] => 2018-10-25 19:15:22 [post_date_gmt] => 2018-10-25 19:15:22 [post_content] => [post_title] => OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => oecd-hrob-2019 [to_ping] => [pinged] => [post_modified] => 2019-04-08 16:57:32 [post_modified_gmt] => 2019-04-08 16:57:32 [post_content_filtered] => [post_parent] => 0 [guid] => http://ilsirf.org/?post_type=event&p=8650 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 8649 [post_author] => 65 [post_date] => 2018-10-25 19:13:39 [post_date_gmt] => 2018-10-25 19:13:39 [post_content] => [post_title] => OECD Working Group on the Safety of Novel Foods and Feeds [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => oecd-snff-2019 [to_ping] => [pinged] => [post_modified] => 2019-04-16 20:49:03 [post_modified_gmt] => 2019-04-16 20:49:03 [post_content_filtered] => [post_parent] => 0 [guid] => http://ilsirf.org/?post_type=event&p=8649 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 10130 [post_author] => 65 [post_date] => 2019-01-30 18:56:26 [post_date_gmt] => 2019-01-30 18:56:26 [post_content] =>

Overview

Agenda

Overview

Crop composition is an essential component of the food safety assessment for GE crops that are intended to be used as food. However, it is important to understand the purpose of the data and its context in the safety assessment. Open to attendees of the 15th ISBR Symposium, this workshop provided an opportunity to briefly discuss the rationale for considering crop composition data, how that data is interpreted in the context of the safety assessment, and what the limitations are to compositional studies.

The workshop also introduced participants to a resource for assisting in the interpretation of compositional studies—the ILSI Crop Composition Database. Participants saw a demonstration of the database and its features, highlighting updates and additions to Version 7.0, the latest iteration of the database that was launched in January 2019. Then, participants were provided with a series of exercises designed to help them understand the search reporting function of the ILSI Crop Composition Database, which they were able to walk through using their personal laptop during the workshop.

In order to ensure that organizers could provide assistance to participants while conducting the practical exercises, the workshop was limited to 20 participants and was conducted twice (at 2:00 pm and 4:00 pm). More information about the workshop is available from the International Society for Biosafety Research.

Agenda

Welcome and Introduction

Compositional Assessment as a Component of Food Safety Assessment for GE Plants
Dr. Andrew Roberts, Deputy Executive Director, ILSI Research Foundation Introduction to the ILSI Crop Composition Database
Dr. Bhavneet Bajaj, Scientific Program Manager, ILSI Research Foundation

Practical Exercises

[post_title] => Crop Composition as a Component of Food and Feed Safety Assessment and Hands On with the ILSI Crop Composition Database [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => isbr-ccdb [to_ping] => [pinged] => [post_modified] => 2019-04-08 16:52:50 [post_modified_gmt] => 2019-04-08 16:52:50 [post_content_filtered] => [post_parent] => 0 [guid] => http://ilsirf.org/?post_type=event&p=10130 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 9982 [post_author] => 65 [post_date] => 2018-12-05 19:33:42 [post_date_gmt] => 2018-12-05 19:33:42 [post_content] =>

By Invitation Only. 

The ILSI Research Foundation, in collaboration with ILSI Focal Point in China, conducted the first phase of our Technical Training Program on Safety Assessment of Foods and Feeds Derived from Genetically Engineered (GE) Plants on March 5-7, 2019 in Langfang, China. Aimed at providing Chinese public-sector scientists with in-depth information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from GE crops, Phase I of the program established a baseline understanding of the food safety assessment paradigm, toxicity and allergenicity testing, compositional assessment, and animal testing. Planned for June 2019, Phase II of the training will include laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted.

Participants were asked to complete the eLearning module “Concepts in the Safety Assessment of Novel Food and Feed” in advance of the Phase I workshop.

Agenda

Day 1

Day 2

Day 3

Day 1

Introduction of Key Concepts and Regulatory Landscape

Welcome and Overview of the Workshop
Dr. Bhavneet Bajaj, ILSI Research Foundation Regulation of Genetically Engineered Foods and Livestock Feeds in China
Mr. Peilei Liu, Ministry of Agriculture and Rural Affairs International Guidance for Assessing Foods and Feeds Derived from Genetically Engineered Plants
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI) Key Concepts in the Risk Assessment of Genetically Engineered Crops
Dr. Monica Garcia-Alonso, Estel Consult, Ltd.

Question & Answer Session

Applying Problem Formulation to the Safety Assessment of Genetically Engineered Foods and Feeds
Dr. Monica Garcia-Alonso, Estel Consult, Ltd.

Breakout Exercise 1

Accessing Information: Useful Resources for Genetically Engineered Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation

Breakout Exercise 2

Day 2

Delving into Food and Feed Safety Assessments (I)

Recap and Questions from Day 1

Key Concepts in Genetically Engineered Food/Feed Assessment: Compositional Analyses
Dr. Monica Garcia-Alonso, Estel Consult, Ltd. Accessing Crop Compositional Data to Inform Genetically Engineered Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation

Breakout Exercise 3

Characterization of the Genetic Modification and the Novel Protein(s)
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI)

Breakout Exercise 4

Assessing Potential Toxicity of Proteins Expressed in Genetically Engineered Crops
Dr. Jason Roper, Corteva Agrisciences

Breakout Exercise 5

Day 3

Delving into Food and Feed Safety Assessments (II)

Recap and Questions from Day 2
Dr. Monica Garcia-Alonso, Estel Consult, Ltd. Understanding Animal Feeding Studies in the Context of Genetically Engineered Food/Feed Safety Assessments
Dr. Jason Roper, Corteva Agrisciences

Plenary Group Discussion

Assessing Potential Allergenicity
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI)

Breakout Exercise 6

Risk Communication
Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI) Feedback, Discussion, and Review
Dr. Monica Garcia-Alonso, Estel Consult, Ltd. Preparing for the Phase II Workshop
Dr. Monica Garcia-Alonso, Estel Consult, Ltd.

Presentation of Completion Certificates & Workshop Closure

Phase II

A five-day workshop is planned for June 2019, focusing on laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted. Phase II will include a review of the concepts from Phase I, with an additional focus on critical reading and review of study reports. Participants will be asked to complete the eLearning module “Application of Problem Formulation for Food and Feed Safety Assessment” in advance of the Phase II workshop.

Speakers

Dr. Mònica García-Alonso, Estel Consult, Ltd.

Dr. Mònica García-Alonso is an independent consultant and director at Estel Consult, Ltd. She has been working in the area of risk assessment of genetically modified crops and regulatory affairs for more than 20 years. She holds a bachelor’s degree in biology, with a specialty in zoology and entomology, and a master’s degree in insect physiology and ecology from the University of Barcelona, as well as a doctorate in neurobiology from the University of Reading. She worked for Syngenta for 19 years and set up her own consultancy eight years ago. She now supports private and public research activities aimed at developing GM crop solutions and provides training on risk assessment to regulators and developers around the world.

Dr. Donald MacKenzie, Institute for International Crop Improvement (IICI)

Dr. Donald MacKenzie is the Executive Director of the Institute for International Crop Improvement (IICI). He manages the IICI’s programs and partnerships dedicated to translating key discoveries in plant health, disease and pest management, genomics, advanced breeding, and nutrition to staple crops that impact food security around the globe. Don also provides guidance on navigating through the practical, safety, and regulatory processes necessary to demonstrate that new crop varieties are proven safe and effective for the farmers who will benefit from them.

Don is an international expert in regulatory systems for agriculture, including environmental risk assessment, biosafety, and food safety assessments. His extensive experience in plant product development and global regulatory processes aligns with the Institute’s commitment to collaborate with international and local partner organizations to deliver crops with improved nutritional content and disease resistance to places where people are in most need. In addition to feeding the hungry, these efforts have the potential to contribute to environmental health and empower farmers to become more self-sufficient.

Dr. Jason Roper, Corteva Agrisciences

Dr. Jason Roper earned his B.S. in Biomedical Science with a minor in Chemistry from Western Michigan University in 1997. He then completed his M.S. and Ph.D. in Molecular Toxicology and Environmental Medicine at the University of Rochester School of Medicine and Dentistry in 2004 and 2005, respectively. Following his post-graduate studies, Jason worked for six years as Senior Toxicologist and Study Director at a contract research organization specializing in GLP mammalian toxicology studies. He joined DuPont Pioneer in 2011 as Research Scientist and Toxicologist, managing a team of scientists responsible for the planning and execution of mammalian, livestock, and avian toxicology studies to support product safety evaluations for global regulatory submissions of genetically modified organisms (GMOs), including insect-resistant and herbicide-tolerant maize, soybean, rice, and canola products.

Jason joined the DuPont Central Research and Development (CR&D) group at Haskell Global Centers for Health and Environmental Sciences in 2013 as Principal Investigator and Senior Research Toxicologist, providing consulting services for the several DuPont businesses in the agricultural, biotechnology, and food industries. Following the merger of DOW with DuPont in 2017, Jason led the general, neuro- and inhalation toxicology competencies at Haskell Global Centers until transitioning to the Corteva Agrisciences (a division of DowDuPont) seeds business in 2019, as a subject-matter expert for regulatory toxicology and product safety. Jason has served as Chair of the CropLife International Toxicology Expert Team (2016-2018) and the DuPont Agricultural Animal Resource Committee (2016-present), Vice-Chair of the Haskell Animal Welfare Committee (2013-2017), and is a member of the HESI Protein Allergen, Toxin, and Bioinformatics (PATB) group and the Haskell Contract Laboratory Evaluation and Approval Team (2015-present).

Dr. Bhavneet Bajaj, ILSI Research Foundation

Dr. Bhavneet Bajaj joined the ILSI Research Foundation as Scientific Program Manager in July 2018. She has worked in academia, the biotechnology industry, and the US Department of Agriculture (USDA) and has a combined research and teaching experience of 12 years.

Dr. Bajaj has worked on plant secondary metabolites of nutritional, agricultural, and medicinal importance. Prior to joining the ILSI Research Foundation, Dr. Bajaj held the position of Visiting Scientist at the Sustainable Agricultural Systems Laboratory, Agricultural Research Service, USDA, where she worked on carotenoid pathway regulation in high polyamine containing tomatoes. Before then, she was an Associate Investigator with the Plant Protection Group at DuPont, where she worked on metabolic engineering as a strategy for insect control in soybean. During her postdoctoral training, she worked on targeted metabolite profiling of triterpene glycosides and phenolic acids in cell suspensions of black cohosh and developed an in vitro protocol for accelerating its seed germination. Dr. Bajaj has also worked as an Assistant Professor at Jaipur National University, India, where she taught genetic engineering, enzymology, and biochemistry courses to masters level students.

Dr. Bajaj received her M.Sc. and Ph.D. in Biotechnology from Guru Jambheshwar University of Science and Technology, India. Her graduate level research comprised of genetic diversity studies on bacterial blight pathogen of clusterbean using molecular markers.

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By Invitation Only. 

The ILSI Research Foundation, in collaboration with ILSI Focal Point in China, conducted the first phase of our Technical Training Program on Safety Assessment of Foods and Feeds Derived from Genetically Engineered (GE) Plants on March 5-7, 2019 in Langfang, China. Aimed at providing Chinese public-sector scientists with in-depth information about the purpose, design, and conduct of studies used to inform safety assessments of foods and feeds derived from GE crops, Phase I of the program established a baseline understanding of the food safety assessment paradigm, toxicity and allergenicity testing, compositional assessment, and animal testing.

Phase II of the technical training, comprised of laboratory tours and demonstrations of how tests are managed and conducted, as well as how data are collected and interpreted, is scheduled to take place on July 17-21, 2019 in Washington, DC and Ashland, OH, USA. The training includes a review of the concepts from Phase I, with an additional focus on critical reading and review of study reports.

Participants are asked to complete the eLearning module “Application of Problem Formulation for Food and Feed Safety Assessment” in advance of the Phase II workshop.

Agenda

Day 1

Day 2

Day 3

Day 4

Day 5

Day 1

ILSI Research Foundation · Washington, DC
Monday, June 17, 2019 · 09:30-16:30
Welcome, Introduction, and Overview of the Workshop
Dr. Bhavneet Bajaj, ILSI Research Foundation Recap of Phase I: Basic Concepts in the Safety Assessment of Novel Foods and Feeds, Problem Formulation Methodology, and Guidelines and Methods
Dr. Mònica García-Alonso, Estel Consult, Ltd. Review of eLearning Modules
Dr. Mònica García-Alonso, Estel Consult, Ltd. FDA Regulation of Food from New Plant Varieties: An Overview
Dr. Patrick Cournoyer, US Food & Drug Administration EPA Regulation of Plant-Incorporated Protectants
Dr. Chris A. Wozniak, US Environmental Protection Agency

Day 2

ILSI Research Foundation · Washington, DC
Tuesday, June 18, 2019 · 08:30-16:00
Understanding the American Public’s Perceptions of Genetically Modified Food
Dr. Cara L. Cuite, Rutgers University Public Opinion on GE Plants and Food and Feed Derived from Them: China
Dr. Xenia Morin, Rutgers University Breakout Groups: Exercise 1 - Risk Communication Group Discussion and Q&A on Public Perception and Communication
Dr. Xenia Morin, Rutgers University New Plant Breeding Techniques: Global Status of Regulation of Products for Food and Feed Use
Dr. Bhavneet Bajaj, ILSI Research Foundation Breakout Groups: Exercise 2 -Safety Assessment of Provided Case Studies (Case 1: Cry1Ac, Case 2: IPD072Aa), Group Presentations, and Discussion
Dr. Mònica García-Alonso, Estel Consult, Ltd.

Day 3

Charles River Laboratories · Ashland, OH
Wednesday, June 19, 2019 · 08:30-17:30
Introduction to CRL and Rules
Leanne Silvis, Charles River Laboratories Animal Welfare, Human Health, and Safety Considerations for Animal Testing Facilities
Leanne Silvis, Charles River Laboratories Acute Oral Toxicity Studies - (a) Design, Guidelines, and Doses, (b) Surrogate Species, (c) Interpreting Results and Writing Reports
Dr. Jason Roper, Corteva Agrisciences Breakout Groups Exercise 3: Critical Review of Acute Oral Toxicity Studies Data, Group Presentations, and Discussion
Dr. Mònica García-Alonso, Estel Consult, Ltd. Discussion and Q&A
Dr. Jason Roper, Corteva Agriscience Quality Assurance & Good Laboratory Practices
Ms. Carrie James and Mr. Kelvin Mentzer, Charles River Laboratories Role of a Study Director
Dr. JoAnna Bultman, Charles River Laboratories

 

Biosecurity, Laboratory, and Vivarium Safety
Leanne Silvis, Charles River Laboratories

CRL Facility Tour

Day 4

Charles River Laboratories · Ashland, OH
Thursday, June 20, 2019 · 08:30-17:00
Presentation on Pathology
Dr. Gary Coleman, Charles River Laboratories CRL In-Depth Facility Tour and Demonstration
Ms. Susana Rodriguez, Mr. William Miller, and Mr. Matthew Bennett, Charles River Laboratories
  • Histology
  • Necropsy
  • Neurobehavioral Testing Suite
  • Inlife Dosing and Blood Collection Demonstration
90-Day Sub-Chronic Studies
Dr. Jason Roper, Corteva Agriscience Breakout Groups: Exercise 4 - Critical Review of 90-Day Feeding Studies Data, Group Presentations, and Discussion
Dr. Jason Roper, Corteva Agriscience

Discussion and Q&A

Day 5

Charles River Laboratories · Ashland, OH
Friday, June 21, 2019 · 08:30-14:30
Bringing It All Together: Writing Relevant and Informative Risk Assessment Summaries
Dr. Mònica García-Alonso, Estel Consult, Ltd. RNAi Food and Feed Safety Assessment
Dr. Xu Hu and Dr. Jason Roper, Corteva Agriscience Investigation of an In Vitro Method for Protein Hazard Characterization
Dr. Jason Roper, Corteva Agriscience

Presentation of Completion Certificates and Workshop Closure

Speakers

Dr. Bhavneet Bajaj, ILSI Research Foundation

Dr. Bhavneet Bajaj joined the ILSI Research Foundation as Scientific Program Manager in July 2018. She has worked in academia, the biotechnology industry, and the US Department of Agriculture (USDA) and has a combined research and teaching experience of 12 years.

Dr. Bajaj has worked on plant secondary metabolites of nutritional, agricultural, and medicinal importance. Prior to joining the ILSI Research Foundation, Dr. Bajaj held the position of Visiting Scientist at the Sustainable Agricultural Systems Laboratory, Agricultural Research Service, USDA, where she worked on carotenoid pathway regulation in high polyamine containing tomatoes. Before then, she was an Associate Investigator with the Plant Protection Group at DuPont, where she worked on metabolic engineering as a strategy for insect control in soybean. During her postdoctoral training, she worked on targeted metabolite profiling of triterpene glycosides and phenolic acids in cell suspensions of black cohosh and developed an in vitro protocol for accelerating its seed germination. Dr. Bajaj has also worked as an Assistant Professor at Jaipur National University, India, where she taught genetic engineering, enzymology, and biochemistry courses to masters level students.

Dr. Bajaj received her M.Sc. and Ph.D. in Biotechnology from Guru Jambheshwar University of Science and Technology, India. Her graduate level research comprised of genetic diversity studies on bacterial blight pathogen of clusterbean using molecular markers.

Dr. Patrick Cournoyer, US Food and Drug Administration

Dr. Patrick Cournoyer is a regulatory scientist in the US Food and Drug Administration’s Office of Food Additive Safety. He helps administer the Plant Biotechnology Consultation Program, which works with plant biotechnology developers to help them ensure the safety of food from new plant varieties prior to marketing. He joined the Federal Government as a class of 2013 Presidential Management Fellow. Patrick received his Ph.D. from Yale University in 2013, where he studied the cell biology of the plant immune system. Prior to graduate school, Patrick worked for the science communication company Genius GmbH in Germany, where he helped develop EU-funded websites to inform consumers about the safety and regulation of genetically engineered plants. Patrick completed a Bachelor of Science in plant science and German studies at McGill University in Montreal, Canada in 2005.

Dr. Cara Cuite, Rutgers University

Dr. Cara Cuite is an Assistant Extension Specialist in the Department of Human Ecology at Rutgers University. Dr. Cuite is a health psychologist who studies community food security, risk communication, and public perceptions of food-related issues, including food safety and genetically engineered foods. More recent projects have focused on communicating about weather-related emergencies as well as interventions to reduce household food, energy, and water use. Her work has been funded by the National Science Foundation, the United States Department of Agriculture, the National Center for Food Protection and Defense, New Jersey Sea Grant, and Johnson & Johnson. She received her Ph.D. in Psychology from Rutgers University and a B.S. in Psychology and Modern Languages from Union College.

Dr. Mònica García-Alonso, Estel Consult, Ltd.

Dr. Mònica García-Alonso is an independent consultant and director at Estel Consult, Ltd. She has been working in the area of risk assessment of genetically modified crops and regulatory affairs for more than 20 years. She holds a bachelor’s degree in biology, with a specialty in zoology and entomology, and a master’s degree in insect physiology and ecology from the University of Barcelona, as well as a doctorate in neurobiology from the University of Reading. She worked for Syngenta for 19 years and set up her own consultancy eight years ago. She now supports private and public research activities aimed at developing GM crop solutions and provides training on risk assessment to regulators and developers around the world.

Dr. Xu Hu, Corteva Agrisciences

Dr. Xu Hu received his B.S. in Plant Protection from Henan Agricultural College, China in 1982. He earned his M.S. in Plant Pathology in 1985 and then worked as a research associate for three years at Institute of Plant Protection, Chinese Academy of Agricultural Science (CAAS), Beijing, China.  He completed his Ph.D. in Molecular Biology and Genetics at the University of Guelph, Canada in 1994.

From 1994 to 1998, Dr. Xu Hu conducted postdoctoral research in Colorado State University, working on the expression of antifungal protein genes in transgenic potato plants and on the improvement of seed oil content in Brassica napus at the Plant Biotechnology Institute, National Research Council of Canada. Xu joined Pioneer in 1998 as a discovery post-doc for molecular characterization of Sclerotinia resistance in transgenic sunflower plant, and then as a senior research associate for the generation of novel resistance against soybean cyst nematode (SCN). As a principal research scientist, Xu led a team working on transgenic resistance to soybean fungal diseases and contributed in RNAi studies on SCN and corn rootworm control. In 2011, Xu took the role of corn rootworm RNAi project leader where he collaborated across functions to progress the RNAi technology through the trait development pipeline. Following the merger of DOW with DuPont in 2017, Xu briefly worked corn diseases and transitioned to input trait discovery, Corteva Agrisciences in 2019, working on genomics-based insecticidal discovery.

Dr. Xenia Morin, Rutgers University

Dr. Xenia Morin is the Senior Associate Dean for Learning, the Undergraduate Program Director for the Agriculture and Food Systems Program, and an Associate Teaching Professor in the Department of Plant Biology at the School of Environmental and Biological Sciences, Rutgers University. Dr. Morin works and collaborates at the intersection of science, social science, and society, and she participates in tackling the formidable challenge of feeding our growing population. As a trained plant biochemist, her research and teaching has grown increasingly interdisciplinary over the years and she now focuses on agriculture and food systems. She has studied, researched, published, and taught on the topic of genetically modified food since 2001 at Bryn Mawr College, Princeton University, and now at Rutgers University.

Dr. Jason Roper, Corteva Agrisciences

Dr. Jason Roper earned his B.S. in Biomedical Science with a minor in Chemistry from Western Michigan University in 1997. He then completed his M.S. and Ph.D. in Molecular Toxicology and Environmental Medicine at the University of Rochester School of Medicine and Dentistry in 2004 and 2005, respectively. Following his post-graduate studies, Jason worked for six years as Senior Toxicologist and Study Director at a contract research organization specializing in GLP mammalian toxicology studies. He joined DuPont Pioneer in 2011 as Research Scientist and Toxicologist, managing a team of scientists responsible for the planning and execution of mammalian, livestock, and avian toxicology studies to support product safety evaluations for global regulatory submissions of genetically modified organisms (GMOs), including insect-resistant and herbicide-tolerant maize, soybean, rice, and canola products.

Jason joined the DuPont Central Research and Development (CR&D) group at Haskell Global Centers for Health and Environmental Sciences in 2013 as Principal Investigator and Senior Research Toxicologist, providing consulting services for the several DuPont businesses in the agricultural, biotechnology, and food industries. Following the merger of DOW with DuPont in 2017, Jason led the general, neuro- and inhalation toxicology competencies at Haskell Global Centers until transitioning to the Corteva Agrisciences (a division of DowDuPont) seeds business in 2019, as a subject-matter expert for regulatory toxicology and product safety. Jason has served as Chair of the CropLife International Toxicology Expert Team (2016-2018) and the DuPont Agricultural Animal Resource Committee (2016-present), Vice-Chair of the Haskell Animal Welfare Committee (2013-2017), and is a member of the HESI Protein Allergen, Toxin, and Bioinformatics (PATB) group and the Haskell Contract Laboratory Evaluation and Approval Team (2015-present).

Dr. Chris A. Wozniak, US Environmental Protection Agency

Dr. Chris A. Wozniak received his training in Plant Pathology and Life Sciences at the University of Nebraska at Lincoln, where his research efforts focused on understanding cell differentiation and morphogenesis in Sorghum bicolor. As a post-doctoral associate, Chris then worked to develop insect resistant cotton and to develop protocols for genetic transformation of sugarbeet. He subsequently joined the USDA-ARS full time to study the biological control of an insect pest in sugarbeet.

After 18 years in plant science research, Chris entered the world of regulatory science at the US Environmental Protection Agency (US EPA), Office of Pesticide Programs as a risk assessor and human health specialist. At EPA, Chris performed risk assessments of microbial and plant-based pesticides, particularly in the areas of human health and environmental consequences of gene flow.

As a Biotechnology Special Assistant in the Office of Pesticide Programs at US EPA, Dr. Wozniak focuses on issues of biotechnology policy, interagency coordination of biotech regulation, and environmental risk assessment of plant-incorporated protectants and sterility mechanisms in mosquitoes.

Group Photo of Phase I & II Participants and Key Faculty (Langfang, China,  March 5, 2019) Group Photo of Phase I & II Participants and Key Faculty (Langfang, China, March 5, 2019) [post_title] => Safety Assessment of Foods and Feeds Derived from Genetically Engineered Plants: Phase II Technical Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => china-phase2 [to_ping] => [pinged] => [post_modified] => 2019-06-10 15:43:27 [post_modified_gmt] => 2019-06-10 15:43:27 [post_content_filtered] => [post_parent] => 0 [guid] => https://ilsirf.org/?post_type=event&p=10928 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 27 [max_num_pages] => 6 [max_num_comment_pages] => 0 [is_single] => [is_preview] => [is_page] => [is_archive] => 1 [is_date] => [is_year] => [is_month] => [is_day] => [is_time] => [is_author] => [is_category] => [is_tag] => 1 [is_tax] => [is_search] => [is_feed] => [is_comment_feed] => [is_trackback] => [is_home] => [is_404] => [is_embed] => [is_paged] => [is_admin] => [is_attachment] => [is_singular] => [is_robots] => [is_posts_page] => [is_post_type_archive] => [query_vars_hash:WP_Query:private] => a44de51df5c995f8cf63ecd74aa4fa4a [query_vars_changed:WP_Query:private] => [thumbnails_cached] => [stopwords:WP_Query:private] => [compat_fields:WP_Query:private] => Array ( [0] => query_vars_hash [1] => query_vars_changed ) [compat_methods:WP_Query:private] => Array ( [0] => init_query_flags [1] => parse_tax_query ) )

eLearning

The ILSI Research Foundation has developed eLearning courses that focus on food safety.

Seven Food System Metrics of Sustainable Nutrition Security

Sustainability considerations have been absent from most food security assessments conducted to date, despite the tremendous economic, environmental, and social implications of meeting accelerating food demand in the face of water shortages and climate change.

Read more

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DOI: 10.3390/su8030196

Background: The world faces an escalating challenge to meet accelerating demand for sustainably-produced, nutritious food in the face of human population pressure, resource scarcity, ecosystem degradation, and climate change. As the ambitious Millennium Development Goals (MDGs) give way to the Sustainable Development Goals (SDGs), about 795 million people globally are still without sufficient calories and at least two billion lack sufficient nutrients.  The ILSI Research Foundation has developed and published a new paper giving a unique set of metrics for measuring food system performance.  The metrics make it possible to set meaningful goals, track progress, and evaluate the potential impact of food system interventions intended to improve sustainability and human nutrition outcomes.

Abstract: Sustainability considerations have been absent from most food security assessments conducted to date, despite the tremendous economic, environmental, and social implications of meeting accelerating food demand in the face of water shortages and climate change. In addition, previous food security work has generally focused only on achieving adequate calories, rather than addressing dietary diversity and micronutrient adequacy, both of which are critical to maintaining a healthy overall nutritional status. In response to the limitations of previous assessments, a new methodology is proposed here based on the concept of “sustainable nutrition security” (SNS). This novel assessment methodology is intended to remedy both kinds of deficiencies in the previous work by defining seven metrics, each based on a combination of multiple indicators, for use in characterizing sustainable nutrition outcomes of food systems: (1) food nutrient adequacy; (2) ecosystem stability; (3) food affordability and availability; (4) sociocultural wellbeing; (5) food safety; (6) resilience; and (7) waste and loss reduction. Each of the metrics comprises multiple indicators that are combined to derive an overall score (0–100). A novel SNS assessment methodology based on these metrics can be deployed by decision-makers and investors to set meaningful goals, track progress, and evaluate the potential impact of food system interventions intended to improve sustainability and human nutrition outcomes.

Download the journal article here.

Resources

Download the metric paper news release here.

Download the 7 food system metrics of sustainable nutrition security infographic available in English or Spanish.

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