Predicting the exact direction of developments in agricultural biotechnology is impossible. What is certain is that federal regulations and other government actions will have a major impact. To help anticipate the future, the USDA Advisory Committee on Biotechnology and 21st Century Agriculture developed a report titled Opportunities and Challenges in Agricultural Biotechnology: The Decade Ahead that USDA released in late August.

The committee consists of 20 members who span biotechnology stakeholders from farmers to biotech companies to consumer organizations who share a common vision of a safe and abundant food supply and a diversified agricultural marketplace, but have diverse views about the appropriate role of plants and animals produced using modern biotechnology in the food and agricultural marketplace. One of its charges is to examine the long-term impact of biotechnology and provide guidance to USDA on pressing issues.

The committee chose to define long term as five to ten years. Some may argue that the long term is much longer than that, but issues that develop over the next five to ten years will likely shape the industry for years to come. The committee identified 26 topics that are relevant to USDA activities. The report is a consensus product of the full committee; except for five topics for which a range of members views is provided.

Some of the reports guidance fits with todays headlines. Adventitious presence (AP) is addressed by two of the topics that include issues related to the discovery in U.S. produced long-grain rice of trace amounts of genetic material from LL601 genetically modified rice. The report explains, Although federal policies address some aspects of AP, the federal government has not set forth comprehensive policies, guidelines, or standards regarding the adventitious presence of transgenic events. The report notes the international market implications, particularly the zero tolerance applied by countries for unapproved varieties. This issue takes on increased importance as U.S. wheat producers consider production of biotech wheat. Wheat was mentioned in the report as a crop that has lost acreage to biotech corn and soybeans in Minnesota and the Dakotas. The committee believes that international trade of biotech crops could be helped by synchronizing approvals across major countries. The U.S. is already suffering from lost markets due to moratoria on approving more biotech crop applications.

The committee had divergent views when addressing most issues related to the role and effectiveness of federal regulations. The committee split over the fundamental issue of whether the Food and Drug Administration (FDA) should make its voluntary consultative process to review food safety data of biotechnology mandatory or if the consultative process should be eliminated and replaced with a mandatory pre-market approval process. Food labeling also split the committee with some supporting mandatory labeling of all biotech products while others believed that foods that were found to be safe should not be labeled just because they were produced with biotechnology. Some members are concerned that the focus has been only on health and safety issues, with little attention to products being wholesome, pure and natural. Transparency in the regulatory system is also viewed as critical. The regulatory process must be aware of gene technologies that are not currently covered by regulations, but may be important in the years ahead. To the extent that federal regulations are viewed as effective, the committee believes this could lessen state regulatory efforts that could fragment the U.S. market and reduce use by producers and acceptance by consumers.

Five topics in the report are related to identity preservation (IdP), either in terms of keeping biotech crops out of an IdP system or keeping biotech crops contained in a system. Some consumers are seeking out biotech free foods and retailers have sent that message back through the supply chain. This has created new opportunities, but also has made the supply chain more complex and created additional commercial liability in both domestic and international trade. Improved standards for sampling and testing will be needed to deal with the increased complexities of the supply chain. Creating a closed supply chain that will keep medical and industrial biotech crops out of the food and feed supply remains a key challenge.

The committee believes that farmers in the U.S. will continue to demand more biotech traits to address production problems and escalating costs. Energy specific traits were mentioned as an area of expected growth. Most of the funding for new biotech traits is from private companies that focus primarily on major crops. Specialty crops may have the same needs, but a smaller market base, and will require other sources of funding for new trait development. Protection of intellectual property rights in international markets will be important in recouping costs for both major crops and specialty crops. A regulatory policy will be needed for imported products using biotech traits developed in other countries and for imported seeds used to grow crops in the U.S. using technology not developed in the U.S.

The biggest new challenges over the next five to ten years will be in livestock biotechnology. Some people who have supported crop biotechnology have a different view when it comes to animals. The committees major concern is that, The federal government has not clearly indicated how and under which laws and regulations transgenic animals will be regulated.

Agricultural biotechnology has been successful in the U.S. in part because the regulatory structure has been flexible enough to allow innovation while addressing food safety and human health issues. Over the next five to ten years the issues will become more complex. The advisory committee report provides ideas on how that balance can be maintained in the years ahead.