Plant Biotechnology Stewardship

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1 October 2011 Plant Biotechnology Stewardship Denise Dewar Executive Director, Plant Biotechnology

2 Plant Biotechnology Global Network バイテク情報普及会 (CBI Japan)

3 Plant Biotech Structure Plant Biotech Strategy Council Plant Biotech Regulatory Steering Committee Plant Biotech Acceptance and Communications Global AP Coalition Steering Committee Global Industry Coalition Steering Committee Stewardship and Industry Responsibility Steering Committee IP Biotech Steering Committee Combined Events PT Detection Methods PT Communications Committee Global Issues Management Team Database Subcommittee Imports Subcommittee Article 18 Workgroup Liability Workgroup Compact Executive Committee Plant related inventions PT Discontinued Products PT Emerging Regulatory Systems Task Force Environmental Risk Assessment PT Regional Acceptance Teams Africa Asia Europe Latin America North America Risk Management Subcommittee Seeds Subcommittee Public Participation/ Socio-economic Considerations Workgroup Risk Assessment Workgroup Trait and Product Stewardship ETS Excellence Through Stewardship Protection of Regulatory Data (PRD) PT

4 Global Area of Biotech Crops


6 Global Adoption Rates (%) for Principal Biotech Crops (Million Hectares, Million Acres), Conventional Biotech % Soybean 64% Cotton 29% Maize 23% Canola Source: Clive James, 2010

7 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.

8 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

9 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.

10 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.

11 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

12 Workshop Manual CropLife Website - pdf copy available for free download

13 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

14 Field Trial Compliance Stewardship Workshops to Date Slovakia, 2009 India, 2008 China, 2007 Mexico, 2006 Vietnam, 2008 Argentina South Africa, 2006 Malawi, 2008 Kenya, 2009

15 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

16 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

17 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

18 Product Launch Stewardship Guidance to promote the responsible commercial introduction of new biotechderived 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

19 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

20 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.

21 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)

22 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)

23 Thank you! Denise Dewar