Plenary Sessions

Joe SmithRay LaytonPlenary Session I
Advancing ERA - Fit for Purpose

Joe Smith, former Gene Technology Regulator, Australia
Ray Layton, DuPont Pioneer, Johnston, IA, USA

Risk assessment is a reasoned, structured approach that uses scientific/technical evidence to support decision making and help address uncertainty. It forms the foundation for regulatory decisions, which are bound by legislative and policy requirements, as well as needs for timely decisions using available resources. Following a short introductory overview, this session will look at some of the major challenges in conducting 'fit for purpose', scientifically rigorous risk assessments that support practical decision making. These challenges include the need for consistent, reliable and transparent generation and use of scientific data to support environmental risk assessments for all types of GMOs, traits and environments, and also the ability to distinguish between essential information and data of marginal relevance or value for evaluating risk. Speakers will describe approaches for designing risk assessments that meet regulatory needs for a variety of countries and environmental scenarios. Strategies to streamline risk assessment processes will be considered, including responding to protection goals, clear criteria for data quality, proportionate risk assessment, alternative methodologies, and effective use of simple regulatory tools. The session will conclude with a short panel discussion that brings together the key points of 'fit for purpose' regulatory risk assessment.

The agenda for Plenary Session I includes:

10:30-10:40 Introduction – What Do We Mean By ’Fit For Purpose’ Risk Assessment?
Ray Layton, DuPont Pioneer, USA

10:40-11:00 Modernizing Comparative Risk Assessments 
Phil Macdonald and Jaimie Schnell, Canadian Food Inspection Agency, Canada

11:00-11:20 Fit for Purpose Risk Assessment – The Malaysian Experience 
Ramatha Letchumanan, Anita Anthonysamy, Department of Biosafety Malaysia, Malaysia

11:20–11:40 Fit for Purpose Risk Assessment – The Argentinean Experience 
Martin Lema, Biotechnology Directorate, Secretariat of Agriculture, Livestock and Fisheries, Argentina

11:40–12:00 Building Better Risk Assessments with Fewer Resources
Paul Keese and Andrea Robold, Office of the Gene Technology Regulator, Australia  

12:00 – 12:25 Panel Discussion
Joe Smith (moderator), Former Gene Technology Regulator, Australia 

Hector QuemadaKwabena BosompemPlenary Session II
Advancing ERA – For Africa

Hector Quemada, Donald Danforth Plant Science Center, St. Louis, USA
Kwabena Bosompem, Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Ghana

The safe adoption of GM technology has particular challenges for Africa, due to factors such as the lack of complete regulatory systems, limited financial and human resources, and limited experience in risk assessment for a wide range of GMOs. This session will examine the needs of Africa in order to implement appropriate risk assessments of GMOs being developed for a wide range of needs on the continent. Speakers will address the role of biotechnology solutions for addressing challenges in food/feed production as well as public health, and the appropriate deployment of this technology. The adoption of strategies discussed in Session I to the specific applications, environments and technological capacities of African countries will also discussed.

The agenda for Plenary Session II includes: 

9:00–9:10 Setting the Context for the Session: Advancing ERA – for Africa
Kwabena Bosompem, Noguchi Memorial Institute for Medical Research, University of Ghana, Ghana 

9:10–9:50 Keynote: Building Technological Capability for Controversial Biotechnologies In Tanzania–A Decision-Making Perspective
Flora Ismail Tibazarwa, Tanzania Commission for Science and Technology, Tanzania

9:50–10:15 An Overview of GMO Research and Development in Africa
Lawrence Kent, Bill & Melinda Gates Foundation, USA 

10:15-10:45 Coffee Break

10:45–11:10 Challenges and Solutions for Implementing Risk Assessment and Risk Management at the Research Stage in Africa: The Case of Uganda
Barbara Z Mugwanya, Yona Baguma and Gilbert Gumisiriza, National Agriculture Research Organization, Uganda 
Julius Ecuru, Uganda National Council for Science and Technology, Uganda

11:10–11:35 Environmental Risk Assessment and Commercial Release in Africa: Challenges and Solutions
Wadzanayi P Mandivenyi, National Department of Environmental Affairs, South Africa 

11:35–12:00 Post-Commercialization Monitoring and Product Stewardship in Africa: Challenges and Solutions
Walter Alhassan, Biotechnology  And Stewardship For Sustainable Agriculture In West Africa (BSSAW), Ghana 

12:00–12:25 Panel Discussion
Hector Quemada (moderator), Donald Danforth Plant Science Center, USA 
Kwabena Bosompem (moderator), Noguchi Memorial Institute for Medical Research, University of Ghana, Ghana 

Morven McLeanMonica Garcia-AlonsoPlenary Session III
Advancing ERA – A Global Perspective

Morven McLean, Center for Environmental Risk Assessment, ILSI Research Foundation, Washington, DC, USA
Monica Garcia-Alonso, Estel Consult Ltd., UK

Environmental risk assessments (ERAs) provide a means of objectively applying scientific knowledge to inform regulatory decision making.  Since ERAs are part of national regulatory approval processes for genetically modified organisms in most countries, it is often the case that data production and analyses are replicated for the same or like products.  Harmonization of environmental risk assessment criteria between countries is recognized as a key component of efforts to address regulatory and trade challenges arising from asynchronous approvals, and is a driver for regional efforts to rationalize the allocation of limited human, financial and institutional resources required to develop and regulate GMOs.  Such technical harmonization is facilitated by coherence in ERA methodology, test protocols, and standards for data quality.  This session will introduce four initiatives that, while different in approach and execution, share the common goal of promoting ERA harmonization.

The agenda for Plenary Session III includes:  

9:00–9:10 Setting the Context for the Session
Morven McLean, Center for Environmental Risk Assessment, ILSI Research Foundation, USA 

9:10-9:50 Keynote: Feeding 10 Billion People Sustainably And Equitably
Charles Godfray, Oxford Martin Programme on the Future of Food 

9:50–10:15 Transportability of Confined Field Trial Data for Environmental Risk Assessment of Genetically Engineered Plants: A Conceptual Framework 
Monica Garcia-Alonso, Estel Consult Ltd., UK
Paul Hendley, Phasera Ltd., UK
Franz Bigler, Agroscope, Institute for Sustainability Sciences ISS, Switzerland
Edgar Mayeregger, Unidad de Gestin del Riesgo, Ministerio de Agricultura, Republica del Paraguay
Ronald Parker, Environmental Fate and Effects Division, Office of Pesticide Programs, USA
Clara Rubinstein, ILSI Argentina, Argentina
Emilio Satorre, IFEVA – Cátedra de Cerealicultura, Facultad de Agronomía y Veterinaria, Argentina
Fernando Solari, Monsanto Argentina SAIC, Argentina
Morven McLean, Center for Environmental Risk Assessment, ILSI Research Foundation, USA

10:15–10:45 Coffee Break 

10:45–11:10 Progress and Challenges for Implementation of the Common Market for Eastern and Southern Africa (COMESA) Policy on Biotechnology and Biosafety
Michael Waithaka and Miriam KyotalimyeAssociation for Strengthening Agricultural Research in Eastern and Central Africa, Uganda
Getachew Belay, Alliance for Commodity Trade in Eastern and Southern Africa, COMESA Secretariat, Zambia
Margaret Karembu, International Service for the Acquisition of Agri-biotech Applications, Afri-centre, Kenya

11:10–11:35 Under the Cartagena Protocol, Where is the Roadmap for Risk Assessment of Living Modified Organisms Taking Us?
Helmut Gaugitsch, Environment Agency Austria, Austria 

11:35–12:00 Making Protection Goals Operational for Use in Environmental Risk Assessments – An EFSA Perspective
Yann Devos, Reinhilde Schoonjans, Agnès Rortais, Sara Tramontini, Franz Streissl, European Food Safety Authority (EFSA), Italy

12:00–12:25 Panel Discussion 
Morven McLean (moderator), Center for Environmental Risk Assessment, ILSI Research Foundation, USA