Food & Agriculture

Outreach: States >

In 2004, BIO’s Food and Agriculture Section (FAS) marked significant progress towards global acceptance of agricultural uses of biotechnology. To take a page from the McDonald’s marketing book, picture a big, green John Deere tractor with a seed hopper saying “one billionth acre planted” and “billions served” and you have the story of farmers around the world who have embraced this technology and are not going back. Ag biotechnology is firmly rooted as a tool of modern agriculture.

Globally, biotech seeds sprouted on 200 million acres in 2004, up 20 percent over the 167 million grown in 2003. For the first time, growth in developing countries outpaced growth in industrialized countries. There is cautious optimism that the global area and number of farmers planting biotech crops will continue to grow in 2005 and beyond.

Within the FAS, BIO and its members have undergone an internal reorganization to become more strategic and member-driven. First, a newly formed Coordinating Committee, comprised of FAS committee chairs, identified six key priorities for 2004, with the goal of focusing on fewer objectives and performing them exceedingly well. These priorities set the course for BIO’s FAS legislative, regulatory and communications efforts in 2004.

The growth of biotechnology in agriculture, food, animals and plantmade pharmaceuticals has expanded at a rate that requires increased, strategic management of multiple programs. Accordingly, Sean Darragh was named in June 2004 to the newly created post of executive director for the FAS. Darragh’s charge is to direct diplomatic, legislative, regulatory and communications strategy for the FAS, as well as manage day-to-day operations, budget and staff.

As 2004 ended, the final piece of the transition was in place with the integration of the Council for Biotechnology Information (CBI) and its communications programs into BIO. CBI was created in 2000 to highlight the benefits of plant biotechnology and to serve as an information resource for the food industry and grower groups who felt “under attack” by a small, but vocal, group of antitechnology activists. Today, as the industry begins its second decade of commercialized plantings, the controversy has largely subsided in the United States.

FAS STRATEGIC PRIORITIES
Adventitious Presence
In April 2004, BIO and the U.S. grain industry jointly urged the Bush administration to expedite a science-based policy governing incidental, trace amounts—or so-called “adventitious presence”—of biotechnology-produced proteins in raw and processed grains and oilseeds, as well as food and feed.

In November 2004, the FDA submitted the long-awaited guidance document for publication in the Federal Register. The guidance incorporates many of the principles first outlined by the Office of Science and Technology Policy in 2002 and was subject to a public comment period ending in January 2005.

As proposed, the new policy provides safety assurance while recognizing a biological material’s potential to appear in trace amounts at unexpected places as a result of biological factors, mechanical mixing, pollen and seed movement, handling and other transportation-related activities.

This proposal ensures that proteins from biotech crops are scrutinized for food safety earlier in the review process. The result: consumers can be confident that any proteins from biotech crops appearing in foods, even before receiving final regulatory clearance, are safe.

This win for BIO’s FAS is the first step in formulating a global policy that recognizes the biological reality of the potential for inadvertent, intermittent, low-level presence in the food supply of proteins that have not yet completed pre-market review.

APHIS Regulation
In January 2004, the USDA’s Animal and Plant Health Inspection Service (APHIS) published a Federal Register notice of intent to prepare an environmental impact statement on agricultural biotech products.

BIO’s FAS Science and Regulatory Committee has provided extensive comments for the statement, expected to be released in draft form in early 2005.

Insurance Exclusions
In recent years, some insurers have sought to exclude from liability coverage events in which biotech crops are inadvertently mixed with other crops. The FAS Law Committee’s aggressive management of this issue has ensured that exclusions at the farm level remain limited and do not affect grower decisions.

Animal Biotechnology Regulatory Policy
The FAS’s Animal Biotech Committee has been preparing for the release of FDA’s risk assessment on animal cloning and the safety of foods from animal clones and their progeny. BIO actions have included stakeholder meetings, development of messages and briefings with agencies and Hill staff.

Throughout 2004, the group also met with the FDA’s Center for Veterinary Medicine to discuss regulations for transgenic animals, as well as to urge the FDA to define the regulatory path for these products. A meeting with USDA’s Biotechnology Regulatory Services division in December made it clear that this agency will be an important part of the review process in the future as well.

BIO has also been engaged in state initiatives targeting animals. The Animal Biotech Committee, in conjunction with BIO’s State Government Relations Committee, has provided testimony, written comments and letters to several states, including California and Florida, where legislation banning transgenic fish is being considered.

Compliance/Stewardship
In 2004, BIO moved forward with an industry-wide initiative to extend understanding of compliance with federal regulatory requirements governing crops and plants improved through biotechnology. BIO members agreed to pool knowledge gained over 16 years of experience in bringing new products to market and share it throughout the agricultural sector, with businesses, farmers and academic institutions. BIO’s Compliance Task Force has conducted two pilot workshops on compliance regulations for corn and cotton, with participation from commodity experts. The courses will be offered publicly to farmers and academic researchers in 2005.

NEWS HIGHLIGHTS
High Adoption Rate of Biotech Crops Continues

Adoption of biotech crops continued worldwide in 2004. In the United States, biotech varieties accounted for 85 percent of soybeans planted (63.5 million acres), 76 percent of cotton (10.4 million acres) and 45 percent of corn (36.4 million acres).

A study by U.S. food and trade policy analyst C. Ford Runge found that biotech crops are now being grown in 18 countries, and research and development is being conducted in another 45. In addition, the global commercial value of biotech crops grown in the 2003–2004 crop year totaled $44 billion. Runge’s study predicts continued expansion of plant biotechnology in the next decade and beyond.

EU Ends Approval Drought
The European Commission edged closer to ending a six-year moratorium on biotech approvals by authorizing the import of canned or fresh biotech corn (Syngenta’s Bt-11) in May 2004 and approving the import of a biotech corn (Monsanto’s NK603) to use in animal feed in July. In September, the commission approved the first biotech seeds for planting and sale across the European Union (EU).

However, EU agriculture ministers were unable to approve nearly half a dozen other biotech products.

In BIO’s view, the moratorium remains in effect until the backlog of more than 30 product applications is cleared and new submissions are reviewed in a timely manner.

Meanwhile, the EU’s rules on traceability and labeling of biotech foods went into effect in April 2004. The new and more stringent rules lowered the threshold for labeling transgenic products and for the first time require labeling of vegetable oils and other highly refined products that contain biotech ingredients.

The World Trade Organization continued to move forward with a formal complaint filed against the EU by the United States, Canada and Argentina in May 2003. A Dispute Settlement Body was appointed in August and expects to issue a final report on the case by June 2005.

New Product Developments
This past year saw the introduction of two low-linolenic soybeans that will reduce or eliminate trans-fatty acids in processed soybean oil. Though produced through conventional breeding methods, the soybeans (developed by Monsanto and DuPont) are the first in a new generation of products that focus on consumer health benefits.

Also in 2004, scientists at Israel’s Vulkani Institute introduced the first biotech etrog, a fruit that is blemishfree, inexpensive and 100 percent kosher. Etrogs are lemon-like fruits that are used in daily blessings during the weeklong biblical harvest festival.

Scientists at Cairo’s Agricultural Genetic Engineering Research Institute announced the development of drought-tolerant wheat. In 2004, mapping of the honey bee genome, coffee genome and chicken genome were also announced.

Support for Biotech Crops
Diverse voices of support for ag biotech emerged in 2004:

• the United Nations’ Food and Agriculture Organization (FAO);
• the National Academy of Sciences’ Institute of Medicine;
• the British Medical Association;
• France’s food agency, Agence France de Securité Sanitaire des Aliments;
• the Union of the German Academies of Science and Humanities’ Commission on Green Biotechnology; and
• the Vatican.

The FAO found that biotechnology can help poor farmers and developing countries, and the Vatican stated that it is a “moral imperative” to investigate the potential of biotech crops to meet global food needs.

STATE ISSUES

In the United States, the most serious challenges to agricultural biotechnology are now popping up at the state level, particularly in states like California, where ballot initiatives allow activists to bring issues to a vote by gathering relatively few signatures.

California
In March, California’s Mendocino County became the first U.S. county to pass a ban on the growth of biotech plants and animals, and in August, Trinity County’s Board of Supervisors passed an ordinance making it a misdemeanor to grow or raise biotech plants or animals.

In November, residents in Butte, Humboldt,Marin and San Luis Obispo counties faced ballot measures that would have banned biotech plants and animals. The California Farm Bureau, local farm bureaus and the farming community, with support from BIO, worked to educate voters on the benefits of agricultural biotechnology and the potential benefits from continued research. The bans failed in Butte, Humboldt and San Luis Obispo counties, but passed in Marin County, a suburb of San Francisco. The Arcata City Council (Humboldt County) unanimously voted to move forward with an ordinance to ban biotech crops in the city.

Vermont
The Genetically Engineered Seeds Law went into effect in October, requiring seed processors to label biotech seeds and report sales in Vermont. Passage of the law made Vermont the first state to define biotech seeds.Questions remain about the constitutionality of the bill and the effect labels will have on interstate commerce. In December 2004, a meeting between Vermont’s Agriculture Secretary Steve Kerr and the American Seed Trade Association resulted in Kerr’s deciding that current seed labels satisfy the law and no new labeling will be required.

North Dakota
The Go Slow with GMO Committee collected signatures in 2004 for a ballot initiative that would have prohibited the planting or selling of biotech wheat without the approval of the state agriculture commissioner and the establishment of an advisory committee. The committee’s efforts continued even after Monsanto suspended efforts to commercialize biotech wheat. The group was unable to collect the required signatures.

In July, the FDA announced it had found biotech wheat to be safe after a food safety review.

State and Local Preemption
With each ballot initiative, technology opponents refine their language in the hope of overcoming objections. The FAS’s Law Committee is working closely with the State Government Relations Committee and conducting legal research into California with a view toward constructing vehicles to preempt county bans on the planting of biotech crops.

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