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Confined Field Trial (CFT) Data Transportability Workshop

Addis Ababa, Ethiopia

This workshop will introduce the ILSI Research Foundation’s CFT data transportability tool to members of the African agricultural biotechnology community seeking to make more efficient use of resources for evaluating genetically engineered plant biosafety.

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Kick-off Meeting of the Ad-hoc Expert Group for Developing the OECD Consensus Document on the Biology of Mosquito Anopheles gambiae

Addis Ababa, Ethiopia

As a first step in drafting an OECD Consensus Document on the Biology of Mosquito Anopheles gambiae, the ILSI Research Foundation, in partnership with the Foundation for the National Institutes of Health (FNIH) and the African Biosafety Network of Expertise (NEPAD-ABNE), is hosting a meeting of Anopheles gambiae mosquito biology experts.

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Genetic Biocontrol for Invasive Species

Tarragona, Spain

Sponsored by the OECD Co-operative Research Programme on Biological Resource Management for Sustainable Agricultural Systems, this workshop will highlight different approaches to the control of invasive species that make use of transgenic organisms engineered for introduction into a target population in order to reduce or eliminate it.

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By Invitation Only. 

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. The program is designed using a phased approach, with Phase I being a workshop aimed at establishing a baseline understanding of the concepts and principles of GE food and feed safety assessment. Topics will include the whole food safety assessment paradigm, as well as discussion of toxicity and allergenicity testing, compositional assessment, and animal testing.

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

Provisional 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, USA

Regulation of Genetically Engineered Foods and Livestock Feeds in China
TBD

International Guidance for Assessing Foods and Feeds Derived from Genetically Engineered Plants
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Key Concepts in the Risk Assessment of Genetically Engineered Crops
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Question & Answer Session

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

Breakout Exercise 1

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

Breakout Exercise 2

Day 2

Delving into Food and Feed Safety Assessments (I)

Recap and Questions from Day 1
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Key Concepts in GE Food/Feed Assessment: Compositional Analyses
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Accessing Crop Compositional Data to Inform GE Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation, USA

Breakout Exercise 3

Characterization of the Genetic Modification and the Novel Protein(s)
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Breakout Exercise 4

Assessing Potential Toxicity
Dr. Jason Roper, DuPont Haskell Global Centers for Health and Environmental Sciences, USA

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., UK

Understanding Animal Feeding Studies in the Context of GE Food/Feed Safety Assessments
Dr. Jason Roper, DuPont Haskell Global Centers for Health and Environmental Sciences, USA

Plenary Group Discussion

Assessing Potential Allergenicity
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Breakout Exercise 6

Explaining the Safety Assessment to Others
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Feedback, Discussion, and Review

Preparing for the Phase II Workshop
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

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.

[post_title] => Technical Training Program: Safety Assessment of Foods and Feeds Derived from Genetically Engineered Plants (Phase I) [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => china-phase1 [to_ping] => [pinged] => [post_modified] => 2019-02-07 16:22:35 [post_modified_gmt] => 2019-02-07 16:22:35 [post_content_filtered] => [post_parent] => 0 [guid] => http://ilsirf.org/?post_type=event&p=9982 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 10423 [post_author] => 65 [post_date] => 2019-02-11 20:25:27 [post_date_gmt] => 2019-02-11 20:25:27 [post_content] => Overview Provisional Agenda Overview

Most regulatory systems have developed standard test methods and data requirements for addressing the potential effects on non-target organisms (NTO) resulting from their exposure to genetically engineered plants expressing Bt proteins (insecticidal proteins primarily derived from Bacillus thuringiensis). However, recent developments in multiple technologies have led to the production of GE plants that incorporate pest protection without pesticidal proteins (e.g., using RNAi) or use of proteins that are not functionally related to Bt proteins. Although the overall assessment paradigm for GE plants is robust and can still be used to produce NTO assessments, there are ongoing discussions about the appropriate NTO tests and measurement endpoints for these new technologies. When is it appropriate to conduct sublethal endpoint assessment testing? What types of assays should be employed?

To answer such questions, the ILSI Research Foundation is convening scientists from academia, government, and industry to participate in a workshop on sublethal endpoints in NTO testing for non-Bt GE crops on March 5-6, 2019 in Washington, D.C. The criteria for making decisions regarding sublethal endpoint assessment testing that are developed during the workshop will be valuable in guiding future risk assessments of GE plants where sublethal effects on NTOs might be anticipated.

Provisional Agenda

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Confined field trials (CFTs) provide a means to determine whether a genetic modification within a genetically engineered (GE) plant results in unintended effects that could pose a risk to the environment. CFTs are usually performed locally within each individual ”host” country that is considering cultivation of the GE plant, and the CFT data collected is used to inform an environmental risk assessment used for regulatory decision-making. Since the data collected from a CFT involves a comparative assessment of the GE crop to its non-GE comparator, data collected from each new host country CFT is duplicative of prior CFT results and does not further inform risk assessment. One way to avoid the needless cost of duplicating CFT data is to make use of pre-existing CFT data obtained from a similar environment outside of a host country.

To facilitate CFT data transportability, the ILSI Research Foundation has developed a software tool that allows CFT locations to be characterized with respect to agroclimatic zones. This tool allows users to identify the locations of CFT data generated in environments outside of a host country, which are similar and relevant to the environments found within the host country. The ILSI Research Foundation will conduct a CFT Data Transportability Workshop in Addis Ababa, Ethiopia on March 12-13, 2019 to introduce the CFT data transportability tool to members of the African agricultural biotechnology community seeking to make more efficient use of resources for evaluating GE plant biosafety.

Provisional Agenda

[supsystic-tables id=11]

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Invasive species can pose a threat to the environment, agriculture, or human health. Most governmental approaches to control the spread of invasive species are focused on preventing new introductions. However, efforts to address the control of invasive species once they have become established have met with limited success. Genetic biocontrol of invasive species may offer a new opportunity to go beyond prevention and begin to reduce or eliminate invasive species through genetic strategies. This workshop will highlight different approaches to the control of invasive species that make use of transgenic and nontransgenic organisms designed for introduction into a target population in order to reduce or eliminate it. The presentations given on these various approaches will compare them with respect to efficacy, biosafety, practicality, cost, and time frame for implementation.

This workshop is sponsored by the OECD Co-operative Research Programme: Biological Resource Management for Sustainable Agricultural Systems, whose financial support made it possible for some of the invited speakers to participate in the workshop. 

 

Provisional Agenda

[supsystic-tables id=9]

There will be a five minute period included at the end of each 30 minute presentation that will be used for questions and answers.

Registration

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By Invitation Only. 

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. The program is designed using a phased approach, with Phase I being a workshop aimed at establishing a baseline understanding of the concepts and principles of GE food and feed safety assessment. Topics will include the whole food safety assessment paradigm, as well as discussion of toxicity and allergenicity testing, compositional assessment, and animal testing.

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

Provisional 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, USA

Regulation of Genetically Engineered Foods and Livestock Feeds in China
TBD

International Guidance for Assessing Foods and Feeds Derived from Genetically Engineered Plants
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Key Concepts in the Risk Assessment of Genetically Engineered Crops
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Question & Answer Session

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

Breakout Exercise 1

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

Breakout Exercise 2

Day 2

Delving into Food and Feed Safety Assessments (I)

Recap and Questions from Day 1
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Key Concepts in GE Food/Feed Assessment: Compositional Analyses
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

Accessing Crop Compositional Data to Inform GE Food/Feed Safety Assessment
Dr. Bhavneet Bajaj, ILSI Research Foundation, USA

Breakout Exercise 3

Characterization of the Genetic Modification and the Novel Protein(s)
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Breakout Exercise 4

Assessing Potential Toxicity
Dr. Jason Roper, DuPont Haskell Global Centers for Health and Environmental Sciences, USA

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., UK

Understanding Animal Feeding Studies in the Context of GE Food/Feed Safety Assessments
Dr. Jason Roper, DuPont Haskell Global Centers for Health and Environmental Sciences, USA

Plenary Group Discussion

Assessing Potential Allergenicity
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Breakout Exercise 6

Explaining the Safety Assessment to Others
Dr. Donald MacKenzie, Donald Danforth Plant Science Center, USA

Feedback, Discussion, and Review

Preparing for the Phase II Workshop
Dr. Monica Garcia-Alonso, Estel Consult Ltd., UK

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.

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