Pla lant t Bio iotechnol echnolog ogy y St Stewa eward - - PowerPoint PPT Presentation

Pla lant t Bio iotechnol echnolog

• gy

y St Stewa eward rdship hip

Denis ise Dewar Execu cuti tive Dir irecto tor, r, Pla lant nt Bio iote techno chnolog

• gy

October 2011

バイテク情報普及会 (CBI Japan)

Plant Biotechnology Global Network

Plant Biotech Structure

Plant Biotech Strategy Council

Plant Biotech Regulatory Steering Committee Combined Events PT Detection Methods PT Environmental Risk Assessment PT Protection of Regulatory Data (PRD) PT Plant related inventions PT Global Issues Management Team Communications Committee Article 18 Workgroup Public Participation/ Socio-economic Considerations Workgroup Risk Assessment Workgroup

Regional Acceptance Teams Africa Asia Europe Latin America North America

Global AP Coalition Steering Committee Liability Workgroup IP Biotech Steering Committee Global Industry Coalition Steering Committee Plant Biotech Acceptance and Communications Stewardship and Industry Responsibility Steering Committee Trait and Product Stewardship Emerging Regulatory Systems Task Force Risk Management Subcommittee Seeds Subcommittee Imports Subcommittee Database Subcommittee Compact Executive Committee Discontinued Products PT

ETS Excellence Through Stewardship

Global Area of Biotech Crops

Global Adoption Rates (%) for Principal Biotech Crops (Million Hectares, Million Acres), 2010

Source: Clive James, 2010 20 40 60 80 100 120 140 160 180 81% Soybean 64% Cotton 29% Maize 23% Canola 90 33 158 31

Conventional Biotech

49 99 148 198 247 296 346 395 445

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
• ccur 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

Mexico, 2006 Argentina South Africa, 2006 Malawi, 2008 Kenya, 2009 Slovakia, 2009 India, 2008 Vietnam, 2008 China, 2007

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

• pportunity 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

• f 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