Organization Overview & Program Charter Introduction In July 2007, the Biotechnology Industry Organization (BIO) launched the first biotechnology industrycoordinated program to promote the global adoption of stewardship and quality management for the full product life cycle of biotechnology-derived plants1. The program, Excellence Through Stewardship: Advancing Best Practices in Agricultural Biotechnology®, promotes the responsible management of agricultural biotechnology, the continued adoption of plant biotechnology globally, and the enhanced value of biotechnology-derived plant products in the marketplace. In June 2008, the organization Excellence Through Stewardship (ETS) was incorporated as an independent non-profit organization to take over responsibility for the program and to promote the stewardship of biotechnology-derived plant products generally. Stewardship is defined as the responsible management of a product from its inception through to its use and ultimate discontinuation. In plant biotechnology, stewardship includes careful attention to the responsible introduction and use of products. The purpose of this document is to describe the ETS organization and to set forth the Excellence Through Stewardship® program for use by members, prospective members and stakeholders engaged in research, development or commercial activities involving biotechnology-derived plant products, including commodity crops, specialty crops, energy crops, perennials, ornamentals, plant-made pharmaceuticals and plant-made industrial products. Organization Overview Officially incorporated on June 16, 2008, Excellence Through Stewardship (ETS) is a non-profit 501(c)(4) educational organization established to “promote the responsible management of plant biotechnology, primarily by developing and encouraging implementation of product stewardship practices and by educating stakeholders and the public about those practices”.2 ETS publishes guides designed to promote stewardship and quality management across the entire plant biotechnology industry. The Guides are disseminated widely to members and made publicly available. ETS works with interested parties to identify resources for making stewardship and quality management information and training available, both to its members and to others involved in the development and production of biotechnology-derived plant products, including academics, contractors, cooperators, licensees and other seed producers, trait providers and researchers. 1 This product life cycle is described in Principles for Risk Analysis and Guidelines for Safety Assessment of Foods Derived from Modern Biotechnology, Codex Alimentarius Commission, World Health Organization, 2004. 2 ETS Articles of Incorporation, June 16, 2008. Revised March 2011; Revisions Approved by Board of Directors March 17, 2011 EXCELLENCE THROUGH STEWARDSHIP Organization Overview & Program Charter Through global education and outreach efforts, ETS aims to become the trusted source for information on stewardship and quality management practices in the plant biotechnology industry. In addition to providing information, ETS promotes the adoption of stewardship programs and quality management systems within the plant biotechnology industry. The organization maintains an extensive list of stakeholder groups around the globe to help carry out its mission to educate stakeholders about industry stewardship activities. ETS manages the Excellence Through Stewardship® Program, seeks to ensure that a sufficient pool of auditors trained on the program is available, reviews Audit Plan submissions from member participants, and maintains a process for receiving the independent, Excellence Through Stewardship® Qualified Auditor report that verifies that a member company has conformed to the audit requirements. ETS distributes certificates to those members that it concludes have successfully completed their applicable audit requirements as determined by their size and scope of operations. Membership in ETS is encouraged for those public/private entities involved with plant biotechnology to achieve a truly robust approach to stewardship of this technology. ETS aspires to enhance acceptance and sustainability of plant biotechnology. ETS also maintains the website www.ExcellenceThroughStewardship.org, which features the Guides (including all available translations), information on the audit process, a list of qualified auditors and an extensive list of international web-based resources on agricultural biotechnology and stewardship. Program Charter The Excellence Through Stewardship® Program includes three major components that are continuously improved upon by ETS and its members. Excellence Through Stewardship® Program Components: Stewardship Objectives, Principles and Management Practices address measures that all ETS members are required to adopt and abide by to contribute to responsible product management. Guides to Understanding and Implementing Stewardship Programs and Quality Management Systems promote stewardship and quality management practices for the responsible use of biotechnology-derived plant products globally. A Global Stewardship Audit involves third-party audits of ETS members to verify that appropriate stewardship programs and quality management systems are in place. Stewardship Objectives, Principles and Management Practices ETS requires that, as a condition of receiving and maintaining ETS membership status, each ETS member shall agree to adopt and abide by the Excellence Through Stewardship® Program Objectives, Principles, and Management Practices. 2 EXCELLENCE THROUGH STEWARDSHIP Organization Overview & Program Charter Objectives: All ETS members fully comply with applicable regulatory requirements. All ETS members seek to achieve and maintain plant product integrity. All ETS members work to prevent trade disruptions in order to facilitate the flow of goods in commerce. Principles and Management Practices: 1. ETS Members shall define and document that stewardship programs and quality management systems are in place for the full product life cycle, designed to achieve the above-described Objectives. Such programs shall address the following phases of the product life cycle, as applicable to their scope of operations: Crop Utilization Such programs shall include: 1) defined policies, processes, and procedures for responsible product stewardship and quality management; 2) defined roles and responsibilities that focus on developing, maintaining and improving policies, processes, and procedures; and 3) awareness and training programs for employees, contractors, licensees and growers as a continuous learning process. 2. ETS Members shall implement an appropriate third-party audit program that follows approved Excellence Through Stewardship® Program audit protocols and verifies that stewardship programs and quality management systems are in place. 3. ETS Members shall include appropriate stewardship and quality management requirements, practices or specifications in applicable contracts and agreements involving plant biotechnology with third parties, including contractors, cooperators, licensees, researchers, suppliers and academic institutions. Inclusion of these provisions must be designed to achieve the Excellence Through Stewardship® Program Objectives and be consistent with the Excellence Through Stewardship® program Principles and Management Practices. 4. ETS Members shall reach out to others involved in the development and production of biotechnology-derived plant products with whom they have established commercial or professional relationships, such as academics and other seed producers, trait providers and researchers, and encourage them to implement and utilize stewardship programs and quality management systems consistent with the Excellence Through Stewardship® Program Objectives, Principles and Management Practices. 5. ETS Members shall engage others in the food, feed, energy and fiber value chain with whom they have established commercial or professional relationships, such as growers, commodity processors 3 EXCELLENCE THROUGH STEWARDSHIP Organization Overview & Program Charter and exporters, food processors, and their trade associations, to promote stewardship programs and quality management systems. Guides to Understanding and Implementing Stewardship Programs and Quality Management Systems The Excellence Through Stewardship® program Guides provide guidance on how to develop and implement stewardship programs and quality management systems from discovery through commercialization and post-market activities. They are produced in a “ready-to-use” format for implementation by individual ETS members and others to suit their organization-specific activities and operations. ETS Members may use the Guides to develop their own practices and operating procedures in order to achieve the Excellence Through Stewardship® program Objectives, Principles and Management Practices. Global Stewardship Audit As part of the implementation of the Excellence Through Stewardship® program Objectives, Principles and Management Practices, ETS members shall have global stewardship audits conducted to verify that appropriate stewardship programs and quality management systems are in place. Such audits shall be conducted by independent, third-party auditors who have successfully completed the Excellence Through Stewardship® Auditor Training Program and received their “Excellence Through Stewardship® Qualified Auditor” certificate. Excellence Through Stewardship® Audits shall be performed using Excellence Through Stewardship® consolidated audit checklists, as applicable to the ETS member’s specific activities and operations, at specified intervals, and at member expense. Conclusion The goal of the ETS organization and the Excellence Through Stewardship® program is to promote the use of stewardship programs and quality management systems across the entire spectrum of organizations involved with plant biotechnology. This is accomplished in part through providing information, Guides and access to other resources that may assist a member organization in fully implementing and continually improving these programs and systems. Should a member organization fail over time to live up to its obligations, such action will be viewed as conduct detrimental to the best interests of ETS, and could result in revocation of ETS membership pursuant to ETS’s Bylaws, Article III, Section 5. ETS endeavors to ensure that this action is avoided by providing positive collaboration and the information needed for member organizations to fully comply with their commitments under the terms and conditions of membership. 4
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