2009 PROGRAM COMPONENTS AND INITIATIVES

MISSION – AND WORK 2008 ACCOMPLISHMENTS 2009 PLANS

WHO IS ETS?  First industry-coordinated initiative established to meet today’s product stewardship and quality management needs  2007 BIO Food & Agricultural Section Governing Board commitment were catalysts for ETS charter  An affiliate of the Biotechnology Industry Organization  Officially charted June 16, 2008  Founding Member Representatives serve as Board members  Industry’s commitment to enhance regulatory compliance and product quality for producers and the value chain

To promote the responsible management of plant biotechnology primarily by developing and encouraging implementation of product stewardship practices and by educating the public about those practices. Excellence Through Stewardship Mission

Defining Stewardship Responsible and ethical management of a product from its inception through to its ultimate use and discontinuation – it includes careful attention to the responsible introduction and use of products. Gene Discovery Plant Development Seed Marketing & Distribution Crop Production Crop Utilization Product Discontinuation Seed Production

 The plant biotechnology industry is committed to the responsible use of the technology  To date, over 40,000 field trials and more than 9,000 permits have been safely completed  Stewardship has been integral part of most companies’ operations since the technology was first developed WHY Industry Stewardship

 BIO Field Trial Compliance Manual/Workshops  Provides an understanding of regulatory requirements for field trials of biotech corn, cotton and soybeans for food, feed and fiber for researchers and farmers conducting trials.  BIO Confinement of Plant-made Pharmaceuticals and Plant- Made Industrial Products  BIO Containment Analysis and Critical Control Point (CACCP) plan  Insect Resistance Management (Regulatory – EPA)  Companies create resistance management plans to delay and impede the spread of any insect resistance that may emerge. Other Current Stewardship Programs

PROGRAM COMPONENTS  Stewardship Objectives, Principles, and Management Practices  Measure all members must accept and abide by  Guides to Understanding and Implementing Stewardship Programs and Quality Management Systems  Uniform direction for industry members to develop stewardship programs  Global Stewardship Audit Program  3 rd party audits to verify that appropriate stewardship programs and quality management systems are in place in member companies

STEWARDSHIP OBJECTIVES  Members achieve full compliance with applicable regulatory requirements  Members maintain plant product integrity  Members work to prevent trade disruptions and facilitate flow of goods in commerce

Principles and Management Practices  Document that stewardship programs are in place for the full product life cycle  Companies include stewardship and quality management requirements, standards, or specifications in applicable contracts and agreements  Reach out to academics and other seed producers, encouraging them to implement and utilize stewardship programs and quality management systems  Engage others in the food and feed value chain to promote alignment of stewardship programs and quality management systems  Conduct third party audits of stewardship programs & quality management systems

STEWARDHIP GUIDES  Specifically designed in a “ready-to-use” format, and easily adapted to organization-specific activities & operations  Incorporates ISO and HACCP program standards and practices  Companies can use to design own best practices  Available for ETS members and non-members  Being translated into several languages for global participation

ETS Guides for Biotechnology-Derived Plant Products  Maintaining Plant Product Integrity  Incident Response Management  Product Discontinuation  Product Launch Stewardship  Stewardship

Guide for Maintaining Plant Product Integrity Includes 5 (stand-alone)modules – can be individually audited against:  Research in the Laboratory  Research in Containment Facilities  Confined Field Trials  Plant and Seed Multiplication  Commercial Plant and Seed Sales

 Steps for a Typical Incident Response Process  Description of Possible Occurrence of Potential Incidents Throughout the Life Cycle  Integrates Practices into overall Planning Process Guide for Incident Response Management

Guide for Product Discontinuation  Clarifies and Defines “Discontinuation”  Provides Considerations for Discontinuation of Products  Gives Steps to Use in Process  Includes: SAMPLE – Certification of Destruction

Guide for Product Launch Stewardship  Urges organizations to develop a product launch stewardship policy  Provides steps to guide an organization through the development of a product launch stewardship policy  Includes a market and trade assessment example

Guide for Stewardship  Provides product developers, providers and stakeholders with stewardship practices along the full plant life cycle  Gives program components to incorporate in each life cycle phase  Defines steps for integrating stewardship into a company quality management program.

 Confirms that stewardship programs and quality management systems are in place and practices conform to ETS guidance  Covers all elements of the plant product cycle – from discovery to breeder seed – within scope of company operations  Companies identify locations of audits to occur in regions, sites and activities ETS Audit Process

 ETS office maintains records of qualified auditors  Auditors in program must have existing auditing credentials, participate in ETS training, and pass an examination to become “An ETS Qualified Auditor”  Auditors send completed report to ETS office  Documentation maintained of company participation ETS Audit Process

Phase I – Implementation (2008)  3 ETS Guides Produced - first Auditor Training Program  ETS founding members agree to Stewardship Objectives, Principles & Management Practices and self-certify that stewardship programs and QMP systems are in place  ETS Stewardship Audits initiated first in U.S. member companies  Adoption of ETS Program Charter providing program direction

Phase II – Implementation (2009)  2009 ETS Audit Process Defined for Member Companies  Complete third-party audits for all ETS members for U.S. plant product activities (discovery through breeder seed)  Translation of Guides and Outreach Materials  Education and Outreach Program includes presentations, workshops, exhibits and new website with translated documents

Phase III – Implementation (2010)  Expanded global education and outreach program  Third-party audits for ETS member company global operations across all phases of the product life cycle  ETS non-member participation plan activated

PROGRAM VALUE AND BENEFITS ETS participation and adopting stewardship programs and quality management systems will: –assist a company’s ability to keep up-to-date on technology and regulatory changes in the industry, –promote the safety of plant biotechnology products for customers, –minimize the likelihood of unexpected incidents and mitigate the impact of unintended releases, and – facilitate the free flow of commerce.

CONCLUSIONS Plant biotechnology provides quality products to the global marketplace for food, fuel, fiber and healing – and its contributions continue to grow. Stewardship programs enhanced global quality management practices to achieve overall goals of safe products in the market place.

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