WASHINGTON (October 3, 2003) Today the Biotechnology Industry Organization (BIO) announced an industry-wide initiative to extend understanding of compliance with federal regulatory requirements governing all crops and plants improved through biotechnology.
“The biotechnology industry has a strong commitment to product stewardship. The continuing advancement of the technology combined with the growing complexity of the federal regulatory system requires that we constantly revisit our training methods, understanding, and adherence to stringent federal requirements,” said Dr. Michael J. Phillips, vice president for food and agriculture science and regulatory policy of BIO.
“With this initiative,” added Phillips, “BIO’s member companies have agreed to pool the knowledge gained over 16 years of experience in bringing new products safely to market and share it throughout the agricultural sector, including commercial entities, farmer-cooperators and academic institutions. The desired outcome is consistent understanding and performance in meeting federal guidelines for regulatory compliance.”
Phillips noted that work for the program began last fall with the creation of a “Beyond Compliance” task force that identified three product stewardship objectives. They are: (1) to achieve consistent compliance with all regulatory requirements in research, development and commercialization of food and agriculture products; (2) establish capacity building and education tools to meet future needs; (3) and develop transparent systems to record and communicate our results and performance. BIO has contracted with AGBIOS to develop training materials and lead pilot learning workshops before the 2004 growing season.
“We have chosen AGBIOS as our partner to execute this program because of their global experience in the areas of regulatory and biosafety capacity,” said Phillips.
“We are excited about this new assignment to help the biotech industry provide consistent training across all agricultural sectors,” said Morven McLean, president of AGBIOS. “The industry already has a strong foundation of training in place – our job is to build on what exists today to meet the needs of the future and to ensure consistency across all parties, both private and public.”
Previous industry commitments to stewardship have included a 2000 announcement that promised assurance that U.S. marketing of biotech seeds for commodity grain for food and feed use would occur only after fully meeting all U.S. regulatory requirements for both human and animal consumption; support of comprehensive and rigorous science-based regulations as required by the appropriate regulatory agencies, including the U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). BIO has also endorsed a mandatory pre-market notification process for FDA review of all biotechnology food and feed products.
The Biotechnology Industry Organization (BIO) represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products. For more information on BIO, visit our website at www.bio.org
AGBIOS is a Canadian company dedicated to providing public policy, regulatory, and risk assessment expertise for products of biotechnology. AGBIOS has worked with federal departments and agencies on issues of policy and regulation pertaining to genetically modified and other novel foods, crops, and forest tree species. The Company also provides experience and expertise to commercial enterprises seeking regulatory approval of biotechnology products, and to other public and private sector groups seeking clarification of issues associated with the development and utilization of biotechnology processes and products.
In the area of regulatory and biosafety capacity building, AGBIOS has developed training programs for the environmental and food safety risk assessment of genetically modified crops. These have been used by third parties as well as for the Company's own use in delivering training workshops in Africa, Latin America, and Southeast Asia. www.agibios.com