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An opportunity to better understand how to comply with federal requirements for regulated field trials - a focus on corn, cotton and soy.
A Commitment to Product Stewardship
The biotechnology industry is committed to consistent and effective compliance with all regulatory requirements in research, development and commercialization of food and agricultural products. Based on its collective experience, the industry has developed a manual and workshop to help educate those conducting regulated field trials on compliance, and on systems they can use to monitor and audit their own compliance.
This 1/2 day session specifically addresses the responsible use of plant biotechnology during the research and development phase that precedes product commercialization. The biotechnology industry has pooled knowledge gained over 16 years of experience in bringing new products safely to market and is sharing that knowledge throughout the agricultural sector, including academic institutions, farmer-cooperators and commercial entities. The goal is to achieve consistent understanding and performance in meeting federal requirements for regulatory compliance.
Who should attend?
- Agricultural research and teaching universities/institutions/governmental agencies conducting regulated field trials in the United States
- Farmer cooperators who are employed by or want to become involved in conducting regulated field trials for technology providers
- Company personnel engaged in regulatory and business management of regulated field trials
What you will learn?
- How to develop tools to create and/or revise your compliance program for regulated articles
- Time proven methods to assist in compliance with regulatory requirements for regulated field trials
- Tried and tested methods to meet federal reporting requirements
This workshop is intended solely as an educational tool to assist participants in better understanding and meeting the U.S. regulatory requirements for conducting regulated field trials of biotech-improved plants intended for food and feed use, as the participants develop their own, individual compliance policies and procedures. This workshop is not intended as, and should not be used as, a substitute for a participant's own individual understanding of the U.S. requirements, for consultation with a participant's legal counsel, or for direct contact with U.S. regulatory agencies, when appropriate. Regulatory requirements may be issued or revised by government agencies after the date of this workshop.
Biotechnology Industry Organization
This project began in the fall of 2002 with the creation of a "Beyond Compliance" task force that identified three product stewardship objectives for the agricultural biotechnology industry. They are: (1) to achieve consistent compliance with all regulatory requirements in research, development and commercialization of food and agriculture products; (2) to establish capacity building and education tools to meet future needs; and (3) to and to develop transparent systems to record and communicate the industry’s results and performance.
A series of pilot programs were created within industry, which are now available to the broader agricultural community. Focus on Corn, Cotton and Soy was developed in conjunction with AGBIOS, a consultancy dedicated to providing public policy, regulatory, and risk assessment expertise to agricultural biotechnology stakeholders in the public and private sectors. AGBIOS also provides experience and expertise to groups seeking clarification of issues associated with the development and use of biotechnology processes and products, and to parties seeking regulatory approval of biotechnology products. In addition to its contribution to BIO's stewardship program, AGBIOS has successfully developed and implemented other educational compliance programs that address the safe management of biotech plants being grown in contained facilities and in experimental field trials.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.
Location: Peabody Hotel
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