Frequently Asked Questions
What is the Excellence Through Stewardship program?
The Excellence Through Stewardship program is the first industry-coordinated program to meet today's product stewardship challenges for the full life cycle of biotech plants into the future.
What are the goals of the Excellence Through Stewardship program?
The program is intended to promote and support company efforts to encourage:
- Full compliance with all applicable regulatory requirements;
- Plant product integrity, so plants will have the desired and expected characteristics;
- The flow of goods in commerce; and
- The prevention of trade disruptions.
Why are BIO and the biotech industry introducing this program?
As biotechnology develops and advances, stewardship practices and responsible management of the technology must also move forward. BIO and its members involved in agricultural biotechnology are committed to this goal.
BIO and the agricultural biotechnology industry are also committed to doing their part to continue to promote safety and trust in the world's food supply and to support smooth international trade transactions in the agricultural community. The Excellence Through Stewardship program is part of BIO's ongoing commitment to promote responsible management and development of agricultural biotechnology. This new stewardship program continues BIO's efforts to offer consistently high quality standards in addressing product stewardship and quality management issues.
Researchers have focused on stewardship from the earliest days of agricultural biotechnology. BIO and its members formed a working group in 2002 to formally leverage the industry's experience and educate a wide audience of users globally on specific best practices to enhance product stewardship. Other current industry stewardship programs managed by BIO and other industry associations include the Insect Resistance Management (IRM) plan, the Compliance Manual and Workshops for Confined Field Trials and the Containment Analysis and Critical Control Point (CACCP) plan for plant-made pharmaceuticals (PMPs) and plant-made industrial products (PMIPs).
Details on the Excellence Through Stewardship program
What is product stewardship? What is quality management?
Product stewardship addresses the scope and depth of technical and business measures that cover the breadth of the product life cycle to promote ethical and responsible management of biotechnology-derived products. Stewardship makes good business sense - careful attention to the safety, safe use and integrity of products and their market impact is essential for high-value products in any industry.
In agricultural biotechnology, meticulous production methods are a business requirement so the seeds sold will yield harvests with the desired and expected characteristics. This is an essential step to producing more and better food, feed and fiber through agricultural biotechnology.
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.
What is the Excellence Through Stewardship program comprised of?
There are three major components to the Excellence Through Stewardship program:
- Stewardship Objectives, Principles and Management Practices
- Guide to Understanding and Implementing a Quality Management Program for Maintaining Plant Product Integrity (QMP Guide)
- Stewardship Audit Program
The principles and management practices address practical and technical measures specific to each phase of the product life cycle, which contribute to responsible product management, including:
- product integrity;
- conduct of field trials;
- product launch;
- incident response; and
- product discontinuation.
These principles and management practices require defined, documented activities to address objectives, planning, training, control and compliance.
The QMP Guide will outline how to develop and implement quality management programs. Many agricultural biotechnology companies already have documented quality management programs. The guide is intended to harmonize approaches and promote a common level of quality management across the entire agricultural biotechnology industry.
The stewardship audit program involves third-party audits of technology providers to verify the implementation of appropriate stewardship programs. These audits will confirm quality management systems and compliance with the principles and management practices.
To which companies does the Excellence Through Stewardship program apply?
BIO's Food and Agriculture Section Governing Body strongly supports the development and implementation of the Excellence Through Stewardship program. Many member companies of BIO's Food and Agriculture Section either already have adopted or have indicated plans to adopt the Excellence Through Stewardship practices. The Excellence Through Stewardship program is intended to assist both BIO members and eventually non-members in developing tailored quality management programs to address the product life cycle phases in which the individual developer is engaged.
To what types of products does the Excellence Through Stewardship program apply?
The Excellence Through Stewardship program can be applied to all biotech-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).
Does this program just apply to the United States?
No. BIO and its members are committed to implementing the program globally. Through a phased-in approach, companies will first have the program in place in the United States and then expand it to their global operations.
How will the stewardship audit program be conducted?
Third-party audits will be conducted at a systems level, at specified intervals and at the member companies' expense.
When will the Excellence Through Stewardship program be implemented?
The Excellence Through Stewardship program is a global stewardship program that will be introduced in a three-phased approach. BIO anticipates that the program will be rolled out in the United States over the next 18 months, and will subsequently be extended globally within three years.
- Phase I - Program participants self-certify that they have adopted stewardship objectives, principles and management practices.
- Phase II - Third-party audits are completed for participants' U.S. plant product activities.
- Phase III - Third-party audits are completed for participants' global plant product operations.
What difference will this program make in the agricultural biotechnology industry?
The Excellence Through Stewardship program is focused on promoting consistently high quality standards. The program will continue the enhancement of the industry's responsible management and development of the technology, as well as increase consistency in quality management across the industry.
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