Frequently Asked Questions
Q. What is Excellence Through Stewardship?
A. Excellence Through Stewardship (ETS) is the first industry-coordinated initiative to promote the global adoption of stewardship programs and quality management systems across the full biotechnology-derived plant product life cycle. ETS is also the name of the non-profit organization that is dedicated to advancing best practices in plant biotechnology through the promotion of the ETS Stewardship Objectives, Principles and Management Practices.
General
Q. What does Excellence Through Stewardship consist of?
A. There are three major components:
- Stewardship Objectives, Principles and Management Practices;
- Guides to Understanding and Implementing Stewardship and Quality Management Systems; and
- A Global Stewardship Audit Process.
In addition, ETS employs a small staff headquartered in Washington, D.C., to help administer these programs.
Q. What are the objectives of these various programs within Excellence Through Stewardship?
A. They are designed to promote and support an organization’s efforts to:
- Fully comply with applicable regulatory requirements;
- Seek to achieve and maintain plant product integrity; and
- Work to prevent trade disruptions in order to facilitate the flow of goods in commerce.
Q. What commitments are made by members upon joining Excellence Through Stewardship?
A. Members of ETS adopt a wide array of principles and management practices in support of the ETS mission. They include:
- Define and document stewardship programs and quality management systems, for the full product life cycle.
- Implement a third-party audit process that follows approved ETS audit protocols and verifies that stewardship programs and quality management systems are in place.
- Include, in applicable contracts and agreements involving plant biotechnology with third parties, stewardship and quality management requirements, practices or specifications that are consistent with the Stewardship Objectives, Principles and Management Practices.
- Reach out to others involved in the development and production of biotechnology-derived plant products, with whom relationships have been established, to promote stewardship programs and quality management systems.
- Engage others in the food, feed, fiber and energy value chain, with whom relationships have been established, to promote stewardship programs and quality management systems.
Q. What is stewardship?
A. Stewardship is defined as the responsible management of a product from its inception through to its use and discontinuation. In plant biotechnology, stewardship includes careful attention to the responsible introduction and use of products. Meticulous production methods are necessary so that seeds produced contain the desired and expected characteristics. This is an essential step to improve production of food, feed, fiber and energy through plant biotechnology.
Q. What is quality management?
A. Quality management is a component of stewardship, which comprises the processes and systems to establish and maintain quality in each phase of the product life cycle.
Q. To what types of products do the major components of Excellence Through Stewardship apply?
A. Each of the ETS components applies to biotechnology-derived plant products that have the potential to enter the food or feed supply, including, but not limited to, commodity crops, specialty crops, energy crops, perennials, ornamentals, plant-made pharmaceuticals (PMPs) and plant-made industrial products (PMIPs).
Q. Do the components of Excellence Through Stewardship just apply to the United States?
A. No. The ETS organization and its members are committed to promoting and implementing each of the objectives and components globally. Through a phased approach, current members first conducted audits in the United States and are now expanding to their global operations. The ETS organization encourages companies, research and academic institutions and technology supporters from around the world to join. Membership Application
Q. What difference will Excellence Through Stewardship make in the plant biotechnology industry?
A. The organization is focused on promoting consistent high-quality practices, the enhancement of the responsible management and development of products of the technology, and encouraging the adoption of quality management systems across the industry.
Q. When did Excellence Through Stewardship begin?
A. The organization was chartered in July 2008 and the first round of audits were performed in the United States during 2008-2009 and extended to include global operations in 2009-2010.
Q. How do the various components of Excellence Through Stewardship complement regulatory compliance?
A. They aim to strengthen and support full regulatory compliance through the requirement to have a management system in place for these and associated activities. The ETS audit process does not replace internal or external audits seeking to confirm regulatory compliance and/or the effectiveness of processes and systems, but the third-party audits conducted under the ETS process do verify that stewardship programs and quality management systems are in place to achieve regulatory compliance.
Q. How does Excellence Through Stewardship enable and align with member stewardship programs and quality management systems?
A. ETS encourages the development and adoption of stewardship and quality management systems across the biotechnology-derived plant product life cycle. The Guides provide a foundation for understanding and implementing these programs and systems. The audit process involves third-party audits of ETS members to verify that stewardship programs and quality management systems are in place. The ETS audits include these elements:
- Stewardship;
- Maintaining Plant Product Integrity;
- Product Launch Stewardship;
- Product Discontinuation; and
- Incident Response Management.
Q. How do the Excellence Through Stewardship principles and management practices, guides and global audit process advance an organization’s stewardship efforts?
A. All aspects of ETS combine to provide a framework for developing an organization’s stewardship programs and quality management systems. Each integrates with and complements members’ other initiatives and audits (including, for example, ISO or GLP) to help provide a comprehensive approach to stewardship and quality management.
Excellence Through Stewardship® Audit Process
Q. How are the stewardship audits conducted?
A. Third-party audits are an integral part of the process and conducted at a systems level, at specified intervals organized by and at the expense of, member companies. ETS-trained auditors examine objective evidence for each of the ETS elements relevant to an organization’s operations.
Q. What portions of a member’s operation are audited?
A. Independent auditors confirm that a member's stewardship programs and quality management systems in support of ETS objectives, principles and management practices are in place through on-site audits at global or regional headquarters and by audits at additional research laboratory, containment facility, field trial and seed production sites, as applicable.
Q. What is meant by a systems audit?
A. A systems audit verifies that the member organization has established quality management systems consistent with ETS objectives, principles and management practices.
Q. Does Excellence Through Stewardship guarantee total effectiveness of systems and processes?
A. ETS, as an organization, cannot make any guarantees in this regard because the elements of ETS are implemented directly by member companies. The third-party audits verify that the member has appropriate stewardship management systems in place. Members are responsible for the implementation of additional activities to verify that stewardship programs and practices are effective.
Organizational Impact
Q. How does Excellence ThroughStewardship apply to technology providers and developers engaged in the research, production and commercialization of biotechnology-derived plant products?
A. The various components of ETS along with the ETS organization are intended to assist both members and non-members in developing and implementing stewardship programs and quality management systems to address the product life cycle phases in which the individual developer is engaged.
Q. Who can be members of Excellence Through Stewardship?
A. Any corporation, business, academic or governmental organization that uses plant biotechnology in the research, development or manufacture of plant biotechnology products is qualified to apply for regular ETS membership.
Q. What value do Excellence Through Stewardship members derive from participation?
A. ETS provides value to members and stakeholders by providing guidance on developing and implementing stewardship programs and quality management systems, and by helping its members to employ a continuous improvement process to help deliver consistent quality of the product throughout its life cycle.
Q. What value do industry stakeholders derive from Excellence Through Stewardship?
A. The three major components of ETS, in conjunction with the support provided by the ETS organization, help provide confidence to stakeholders that ETS members have stewardship programs and quality management systems in place and that stewardship is a key area of focus for the responsible development of these products, which have the opportunity to benefit the value chain for food, feed, fiber and energy. In addition, ETS provides information and educational materials on stewardship and quality management guidance to global stakeholders.