BIOTECH PRODUCTS STEWARDSHIP

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BIOTECH PRODUCTS STEWARDSHIP

• National Workshop
• On
• Pest Risk Assessment and Management
• Manila, Philippines
• May 24-28, 2004

Registered trademarks of Pioneer Hi-Bred
International, Inc. YieldGard and the YieldGard
Corn Borer Design are trademarks used under
license from Monsanto Co.
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Global planting of GM crops 2003

• From 1.7 M ha in 1996 to 67.7 M ha planted to GM
  crops in 18 countries in 2003

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Regulation of Biotech Crops/Products

• The most highly regulated products nowadays
• They are assessed for food, feed and
  environmental safety before allowed import or
  cultivation
• Approval could be event-based or product-based
• Pioneer is committed to good stewardship

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Stewardship

• A process that identifies and reduces Safety,
  Health and Environment risks in every stage of
  the product life cycle
• Conduct business in a way that lessens negative
  impact on the customers, general public or the
  environment today and in the future.
• Activities that contribute to the sustainable use
  of GM crops and products and demonstrates
  responsible use

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Why is it Important ?

• Society demands safety as the right to operate a
  business.
• The future will depend on having products that
  add value and are safe to customers, consumers
  and the environment

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Sustainability and Stewardship DuPont Ag and
Nutrition View

• DuPont has embraced globalization and corporate
  social responsibility as core elements of
  sustainability. Stewardship, like safety, is
  deeply engrained in our approach to business.
• Being responsible for our products over their
  entire lifecycle
• Voluntarily taking responsibility for our
  products
• Managing safety, health, and environmental risk
• Meeting societys needs today without
  compromising the ability of future generations to
  provide for their needs
• DuPont seeks to invent, develop, and market
  technology and innovation that improve peoples
  lives while meeting the needs of customers,
  shareholders, employees, and society.
• Where we operate, we follow the corporate vision
  to deliver financial performance and societal
  value while decreasing our environmental
  footprint.

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Stewardship Efforts at Pioneer
Commercial Product Stewardship
Research and Development Activities
Regulatory Activities
Business and Value Chain Activities
Product Transfer Systems
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Critical Control Points/Activities For Experiment
Execution
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5
4
3
2
Post Trial Monitoring
Experiment Planning
Harvest
Planting
Pollination
RISK
Control Point B
Control Point C
Control Point D
Control Point E
Control Point F
Control Point A
Time/physical isolation, entry list, planting
arrangements
Seed distribution in respective plots
Controlled Isolated
Seed/grain disposal Crop destruct
Roguing of volunteers
Site selection, NCBP approval, seed importation,
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Pioneer Stewardship

• Follows voluntary company policies and standards.
• Increase market acceptance
• Reduce customer/consumer risk
• Maintain and enhance company reputation
• Follows mandatory requirements.
• Regulatory agencies
• Legislative bodies
• Contractual obligations
• Mandatory and voluntary stewardship principles
  are factored into business decisions involving
  biotech crops.
• Demands cooperation and buy-in from highest
  levels.

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Stewardship Pioneer

• What does this mean?
• Everyone responsible mindset
• Assessment at product concept stage
• Allows for turning issues into opportunities
• Early no decisions
• Consultations at each Gateway
• Quality assurance
• Field quality assurance
• Compliance with regulations while in
  research and development stages
• Compliance with post-market regulations
  Product Stewardship

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The Case of Allergenic Soybean

• Pioneer initiated research on transgenic soybean
  to enhance methionine level in poultry feed
• Brazil nut chosen as source of the gene
• Pioneer discontinued the research in 1993 after
  preliminary results from a voluntary experiment
  suggested that the Brazil nut gene transferred a
  potential for allergenicity
• FDA regulation would have allowed the product in
  the market provided it is labeled as having
  allergenic potential.

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Current Issues on Product Stewardship in the
Philippines

• Compliance to the Guidelines on Planned Release
  of Genetically Modified Organisms and Potentially
  Harmful Exotic Species (NCBP)
• Compliance to the Rules and Regulations for the
  Importation and Release into the Environment of
  Plants and Plant Products derived from the use of
  Modern Biotechnology (Dept. of Agric. AO 8)
• Compliance to IRM requirements (DA MC 17)

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Closing

• Product Stewardship is our license to operate
  from society and we have no choice if we want to
  be here in the future.
• We should take the leadership and invest today so
  we have permission to operate our business with
  our partners in the future.
• Education and commitment are basic for our
  success along our value added chain and the life
  cycle of our products - from cradle to grave.

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Takeaway Messages

• Stewardship efforts are aligned with Pioneers
  direction and business goals.
• Stewardship is an organized, integrated and
  necessary function of our business.
• Stewardship is not a stand-alone discipline but
  is cross-functional by design.
• Stewardship is a constantly evolving journey that
  is sensitive to internal and external influence.
• Stewardship done well will be nearly invisible in
  terms of cost and time, but
• Stewardship done poorly can be very costly in
  time, costs and freedom to operate.

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Thank You