Biotechnology Industry Organization

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Excellence Through StewardshipSM is...

• The first industry-coordinated initiative to
  promote the adoption of stewardship programs and
  quality management systems across the full
  biotechnology plant product life cycle.
• Focused on establishing and verifying systems and
  processes to manage stewardship practices.
• Excellence Through Stewardship builds on the
  biotechnology industrys commitment to product
  stewardship and quality management by providing
  guidance to meet important stewardship objectives
  for all those involved.

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• Product Stewardship is
• the responsible management of a product
  from its inception
• through to its use and ultimate discontinuation.

Seed Marketing Distribution
Crop Production
Seed Production
Plant Development
Crop Utilization
Gene Discovery
Product Discontinuation
Biotechnology Plant Product Life Cycle
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Whos Involved

• Companies and organizations who are engaged in
  discovering, developing or commercializing
  biotechnology-derived plant products.
• Founding Members
• ArborGen, LLC
• BASF Plant Science
• Bayer CropScience, LP
• Biotechnology Industry Organization
• Ceres, Inc.
• Dow AgroSciences LLC

• DuPont
• Mendel Biotechnology, Inc.
• Monsanto Company
• SemBioSys Genetics, Inc.
• Syngenta Seeds, Inc.
• Targeted Growth, Inc.

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Components

• Stewardship Objectives, Principles, and
  Management Practices
• - Measures all members must adopt and abide by to
  contribute to responsible product management.
• Guides to Understanding and Implementing
  Stewardship Programs and Quality Management
  Systems
• - For use in developing stewardship programs and
  quality management systems for biotechnology-deriv
  ed plant products globally.
• Global Stewardship Audits
• - Third party audits to verify that stewardship
  programs and quality management systems are in
  place for applicable operations.

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Objectives

• All members fully comply with applicable
  regulatory requirements.
• All members seek to achieve and maintain plant
  product integrity through stewardship programs
  and quality management systems.
• All members work to prevent trade disruptions in
  order to facilitate the flow of goods in
  commerce.
• All members support Excellence Through
  StewardshipSMs efforts to provide stewardship
  guidance and information to biotechnology
  industry stakeholders worldwide.

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Principles Management Practices

• Document that stewardship programs and quality
  management systems are in place.
• Implement independent third-party audits.
• Include stewardship and quality management
  requirements, standards, or specifications in
  contracts and agreements.
• Reach out to others involved in the development
  and production of biotechnology-derived plant
  products, and with whom members have established
  commercial or professional relationships.
• Engage others in the food, feed, fuel and fiber
  value chain to promote stewardship programs and
  quality management systems.

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Guides to Understanding and Implementing
Stewardship Programs and Quality Management
Systems

• Designed in a ready-to-use format to be easily
  adapted to organization-specific activities and
  operations.
• Translated into several languages for global use
  and made publicly available on the Excellence
  Through Stewardship website.

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• Guide for Stewardship -- identifies stewardship
  program considerations in all phases of the plant
  product life cycle.
• Guide for Maintaining Plant Product Integrity --
  identifies considerations for maintaining plant
  product integrity for
• Research in the Laboratory
• Research in Containment Facilities
• Confined Field Trials
• Plant and Seed Multiplication
• Commercial Plant and Seed Distribution
• Guide for Product Launch Stewardship -- provides
  guidance on development of a product launch
  stewardship process and includes an example of a
  market and trade assessment.
• Guide for Incident Response Management --
  identifies considerations for incident response
  planning and management.
• Guide for Product Discontinuation -- identifies
  considerations for systems to manage the
  discontinuation of biotechnology products.

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Global Stewardship Audits

• Trained and qualified, independent third-party
  auditors.
• Audits are conducted on operations from discovery
  through to discontinuation (as applicable).
• Audits target stewardship and quality management
  systems and associated activities throughout the
  product life cycle.
• Members receive an Excellence Through Stewardship
  certificate once successful audits have been
  completed.
• The Guides assist members in the preparation
  process for audits.
• Operational audits are representative, ongoing
  and build over time.

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Excellence Through StewardshipSM in 2009 and
Beyond

• Conduct of third-party audits of members global
  operations across all phases of the product life
  cycle.
• Translation and publication of Guides (Chinese,
  French, Spanish).
• New and expanded website for global education and
  outreach www.ExcellenceThroughStewardship.org
• Translation and production of outreach materials
  (Chinese, French, Japanese, Korean, Portuguese,
  Spanish).
• Implementation of global education and outreach
  programs with other organizations as partners.

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