Biotechnology Industry Approves Product Launch Stewardship Policy

Washington, D.C. (May 21, 2007) — The Biotechnology Industry Organization (BIO) today announced a new forward-looking policy statement that will encourage BIO’s Food and Agriculture members to help facilitate the flow of goods in commerce and minimize the potential for trade disruptions with respect to products of agricultural biotechnology. The Product Launch Stewardship Policy addresses the issue of asynchronous authorizations — where different countries may approve, deregulate or authorize biotech crop varieties at different times. Such variance in regulatory authorizations among trading partners can potentially disrupt trade and commerce of grain products.

Under the new policy, BIO is encouraging its members in its Food and Agriculture Section to seek the appropriate regulatory authorizations from major countries — including the United States, Canada, and Japan — prior to commercializing a new biotech-derived crop.

“Approval of the Product Launch Stewardship Policy is a significant forward-looking action by BIO’s Food and Agriculture Section Governing Body,” said Jim Greenwood, president and chief executive officer of BIO. “It demonstrates that BIO is committed to doing our part to promote the continued safety and trust in the world’s food supply, and to help support smooth trade transactions in the international grain community.”

The Product Launch Stewardship Policy is an extension of domestic and international efforts to develop and advocate for an adventitious presence (AP) policy. Over the last several years, BIO and its members have continually urged U.S. regulatory agencies to implement a science-based policy that governs incidental or trace amounts — or so-called adventitious presence — of biotechnology-enhanced events in raw and processed grains and oilseeds, as well as food and feed. While adventitious presence is a natural part of plant biology, seed production, and the distribution of commodity crops, a science-based policy would support continued food safety for consumers, farmers, food processors, and grain handlers. In 2006, both the U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) introduced their policies on adventitious presence; in March 2007, the U.S. Department of Agriculture published its interim policy on adventitious presence. Additionally, Codex Alimentarius, the international food standards-setting body, has begun work to develop an international food safety standard for adventitious presence.

“The Food and Agriculture Section Governing Body felt that it needed to approve a prospective policy statement that demonstrates strong support for the international trade system and its improvement,” said Andrew Baum, president of SemBioSys, Inc., Chair of the Food and Agriculture Section Governing Body, and Vice Chair and Secretary of BIO’s Board of Directors. “We believe the approval of this Product Launch Stewardship Policy demonstrates our understanding of the concerns grain handlers, exporters, and foreign governments may have about new biotech-derived crops, and it illustrates our organization’s continued commitment to promoting good product stewardship and responsible use of this technology.”

In addition to encouraging authorizations in the United States, Canada, and Japan prior to commercialization, the Product Launch Stewardship Policy also encourages companies to consult with grain handlers and others in the value chain, follow best seed quality practices, as well as develop detection methods for growers, grain producers, processors, and buyers. Finally, it encourages BIO members to promptly communicate broadly and in a transparent manner with stakeholders their company-specific product launch stewardship policies and their implementation.

Founded in 1993, 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 health-care, agricultural, industrial and environmental biotechnology products. BIO produces the BIO International Convention, the world’s largest gathering of the biotechnology industry.