October 2011 hip Pla lant t Bio iotechnol echnolog ogy y St Stewa eward rdship Denis ise Dewar Execu cuti tive Dir irecto tor, r, Pla lant nt Bio iote techno chnolog ogy
Plant Biotechnology Global Network バイテク情報普及会 (CBI Japan)
Plant Biotech Structure Plant Biotech Strategy Council Stewardship Plant Biotech Global Industry Plant Biotech IP Biotech Global AP Coalition and Industry Regulatory Coalition Acceptance and Steering Steering Committee Responsibility Steering Committee Steering Communications Committee Steering Committee Committee Communications Combined Database Article 18 Compact Committee Events PT Subcommittee Workgroup Plant related Executive inventions PT Committee Global Issues Detection Imports Liability Management Team Methods PT Workgroup Subcommittee Trait and Protection of Product Regional Regulatory Discontinued Public Participation/ Risk Management Stewardship Data (PRD) PT Acceptance Products PT Socio-economic Subcommittee Considerations Teams Workgroup Emerging Africa Seeds Regulatory Asia Subcommittee Systems Task Risk Assessment Europe Force Workgroup Latin America ETS North America Excellence Environmental Through Risk Assessment PT Stewardship
Global Area of Biotech Crops
Global Adoption Rates (%) for Principal Biotech Crops (Million Hectares, Million Acres), 2010 445 180 158 395 160 Conventional 346 140 Biotech 296 120 247 90 100 198 80 148 60 33 31 99 40 49 20 0 0 81% 64% 29% 23% Soybean Cotton Maize Canola Source: Clive James, 2010
Stewardship of Plant Biotechnology CropLife International promotes a lifecycle stewardship approach to the management of plant biotechnology products – from gene discovery through to product discontinuation.
Stewardship of Plant Biotechnology • CropLife International is focused on listening and responding to the needs of stakeholders in the value chain (farmers, seed, grain, food & retail sectors, and broader society). • Biotech stewardship focuses on the development of policies responding to theses needs, and product specific stewardship & training where appropriate. • The overall aim of the stewardship approach is to maximise the benefits, and minimise any risks in developing, producing, or using products of plant biotechnology. • Stewardship is a global issue – though manufacture may occur in a different country or region than its eventual use, responsible use of the technology must be consistent around the world
CropLife International Stewardship Program • CropLife’s stewardship program is based on its Code of Conduct • Plant Biotechnology: Code of Conduct • Define shared best practices towards stewardship of the use of plant biotechnology.
Plant Biotechnology: Code of Conduct Describes companies’ commitment to a common set of business ethics and philosophies regarding biotech stewardship. • Safety standards that maximise benefits and minimise risks. • Supportive of intellectual property protection. • Engage in thoughtful dialogue with stakeholders. • Support transparent regulatory processes. • Sharing knowledge and technology in both developed and developing countries. • Use sound and innovative science and thoughtful and effective stewardship in the delivery of our products and services. • Utilize the highest scientific standards when researching and developing plant biotechnology products.
Compliance Management for Confined Field Trials Workshops/Training What is a confined field trial? • a small-scale experiment • with biotech-derived plants • to collect data • carried out under conditions that minimise impact on the surrounding environment
Workshop Manual CropLife Website - pdf copy available for free download
“3 - Ps” of Risk Management for Field Trials Aim to: • Prevent dissemination of new genes from experimental biotech-derived plants into the environment ( i.e. prevent pollen flow) • Prevent the persistence in the environment of the experimental biotech-derived plant and any progeny plants ( i.e. contain seed and planting material) • Prevent the introduction of the experimental biotech-derived material into livestock feed or human food pathways
Field Trial Compliance Stewardship Workshops to Date India, 2008 Slovakia, 2009 China, 2007 Mexico, 2006 Vietnam, 2008 Argentina South Africa, 2006 Malawi, 2008 Kenya, 2009
Resistance Management & Crop Management • Sound management practices enable farmers to maximize the benefits of plant biotechnology to improve crop production • Resistance management programs enable the longevity of plant biotechnology by limiting weed resistance and insect resistance • CropLife International has developed training manuals and workshop materials on - Insect Resistance Management (IRM) - Integrated Weed resistance Management (IWM) and crop management strategies
IRM - Course outline • Introduction to - insect resistant crops - resistance development - stewardship & quality management systems • Developing robust IRM plans • Examples of IRM plans • Implementing an IRM plan (training, monitoring, audit & verification) • Trainings planned in South Africa & Honduras in 2011
IWM - Course outline • Background on - Weeds and Herbicides - Herbicide Tolerant Crops • Tools for IWM • Developing an IWM plan (training, monitoring, audit & verification) • Course includes: - Crop management strategies to manage weeds - Management strategies to minimize development of herbicide resistance weeds
Product Launch Stewardship • Guidance to promote the responsible commercial introduction of new biotech- derived products • Goal: to facilitate the flow of commerce and minimize the potential for trade disruptions • Prior to product launch, due attention to regulatory approval requirements, market assessments, and other provisions • Unique to each company and product
Introduction to “The Compact” — What? • Voluntary Legally-Binding Contract - Created and signed by CropLife International Members to allow countries to seek redress from a Member in the event that the release of an LMO by that Member causes damage to biological damage. • Focus is on Damage to Biological Diversity (damage to “species”) - Does not address traditional harms ( e.g. , personal injury or economic loss). - Damage measured in relation to baseline, and must be a significant and adverse change. • Complements the Nagoya-Kuala Lumpur Supplementary Protocol on Liability & Redress (Nagoya-KL SP), approved on 15 October 2010, with a Form of Financial Security - The Compact is the only existing mechanism that assures both access to those who release LMOs and their ability to pay. • An Option for States - States choose whether to seek redress under The Compact (not private parties or Non- Governmental Organizations!). The Compact provides States with a meaningful opportunity to seek Response under The Compact in lieu of other redress mechanisms that may be available to the State. • No Legal Impact on Non-Members • Response through remediation or compensation
Liability and Redress: Relevance to Stewardship • Demonstrates confidence in the safety of Members’ products. • Evidence of commitment to rigorous stewardship, risk assessment, and risk management to prevent damage to biological diversity. • Publicly available pledge to provide prompt, appropriate, and necessary remedial measures if found responsible for damage to biological diversity. • Fills a void in international and domestic law.
Stewardship and Industry Responsibility Committee • As the global discussion concerning food security, climate change, and environmental responsibility continues to unfold, there is an increasing understanding of the positive role that plant biotechnology can contribute. • This creates both opportunities and challenges for the industry, as the realization of the benefits increases, so too does the demand for the technology to help solve societal concerns. • The industry will be best served by working proactively to contribute solutions to address these issues – UNFCCC, Nagoya Protocol on Access & Benefit Sharing (ABS), International Treaty on Plant Genetic Resources for Food & Agriculture (ITPGRFA)
CropLife International Stewardship Program • Focus for CropLife Biotech Stewardship: - Industry & Research (e.g. Compliance Field Trial Training & through partnering with ETS) - Farmer (e.g. IRM & IWM) - Value Chain - listening, dialoguing & responding as appropriate (e.g. Product Launch Stewardship Guidance) - Society (e.g. Compact & new initiatives examining technology diffusion to those most in need)
Thank you! Denise Dewar denise.dewar@croplife.org
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