A Primer on the "Battle Royale" of the 21st Century

Thomas P. Redick

This article provides readers with an overview of the complex web of international and domestic legal requirements that is rapidly forming around innovation in agricultural biotechnology, and will review the ideas coming out of the Section’s annual Biotechnology Roundtable. It serves as a primer for those who are not well-versed in the twists and turns of international regulation of agricultural biotechnology.

After nearly four years of intense negotiations, the Biosafety Protocol (the Protocol) was adopted on January 29, 2000, in Montreal. It amends the 1992 United Nations Convention on Biological Diversity to require regulation of transboundary movements of genetically modified organisms (GMOs) posing a threat to biological diversity. Immediately after the U.S. declared victory in exempting commodities, individual nations began raising or contemplating trade barriers to commodities and food that "may contain" living modified organisms (LMOs). In support of these trade barriers, these nations cited the Protocol’s vague language about using a "precautionary approach" to potential environmental impacts of LMOs. The stage is set for what Agriculture Secretary Dan Glickman has called the "Battle Royale" of the 21st Century.

The Biotechnology Roundtable Process
Since 1997, the Special Committee on Agricultural Management has hosted an annual Roundtable that has provided the Section with a link to one of the most controversial issues in international and domestic environmental law – the regulation of genetically improved crops and other GMOs. After each Roundtable meeting, a summary of the presentations is published online by the Section’s cooperating organization, the Council for Agricultural Science and Technology (CAST). The fourth Roundtable, scheduled for May 2001, is entitled: "Assessing the Impact of the Biosafety Protocol" – a new international law regulating international trade in LMOs produced using modern biotechnology. The published proceedings of the three Roundtables to date will be referenced to provide the readers with additional background; click on CAST’s site at <http://www.cast-science.org/roundtable.htm> to obtain more details.

The Growing International Furor Over Agricultural Biotechnology
For the past 20 years, plant breeders in the U.S. and around the world have embarked upon an ambitious program to use gene splicing to improve existing varieties of agricultural crops. Scientists involved in improving the world’s food security (that is, feeding the nine billion mouths that are expected to be eating around 2050) have generally assumed that we will need to employ genetic engineering to create crops that will expand production on land already cleared for use.

The Tricky Scientific Issues Underlying Food Safety Risk Assessment
Farmers around the U.S. have adopted agricultural biotechnology in the past few years at a phenomenal pace. Prior to May 1997, when the first Biotechnology Roundtable was held in San Diego, about four million acres of genetically improved crops were planted worldwide (75% in the U.S.). By 1999, approximately 100 million acres of genetically improved crops were planted worldwide. Almost overnight, acreage of genetically improved soybeans, the crown jewel of U.S. grain exports, soared to nearly 60% of U.S. soybean acreage. Corn followed closely behind, only to take a sudden drop in planting when the European Union (EU) denied approval to new varieties of genetically improved corn. The concerns cited by the EU echoed those often heard in the U.S. debate: (1) ecological risks, such as insect resistance to B.t., or disruption of soil microorganisms; and (2) human health risks, such as inclusion of allergen genes (the fear of which led to the recent recall of Taco Bell taco shells containing traces of corn approved only for animal feed).

At the first Biotechnology Roundtable, Dr. Steven Taylor, a leading food allergist, laid out the course of food allergy prevention in the 21st Century. He predicted a leading role for GMOs in reducing allergens in the food supply. Genetically improved crops can be created to delete known allergens from the food supply, and the tools of biotechnology can identify both allergenic foods and people prone to allergenic responses. Skeptics asked Dr. Taylor whether cumulative and synergistic effects could cause allergic reactions. Four years later, these vague concerns of unknown allergens drove Kraft to recall taco shells to avoid exposing consumers to a particular protein in Starlink™ corn.

Remote, largely theoretical food safety issues like these have led the EU to ban imports of certain LMOs. While EU feedlots serve a steady diet of antibiotics to cattle, the EU bars imports of crops containing LMOs with "antibiotic resistance marker genes" (a tool for laboratory identification). This trade barrier was erected due to fears that these genes could move from corn into bacteria in the cow’s digestive tract, and add an unwanted teardrop’s worth of antibiotic resistance in the ocean of antibiotic resistant bacteria that the EU is creating. At the first Biotechnology Roundtable, a consensus of world-class scientists agreed that this risk of "horizontal transfer" (i.e., genes moving between species) was vanishingly small, echoing a conclusion by a near-consensus of global food experts. In May 1997, before trade disruptions had occurred in U.S. and Canadian grain shipments to the EU, the battle lines drawn by Roundtable participants foreshadowed the EU’s fateful "non-decision" delaying import approval to B.t. corn. That decision has cost U.S. agriculture approximately $200 million in annual exports of whole corn since 1997.

Managing Potential Environmental Impacts of LMOs
The Special Committee’s Second Roundtable brought leading scientists and policymakers together to debate the appropriate level of precaution for "Resistant Insects and Superweeds" – the leading potential environmental impacts identified for genetically improved crops to date. Insect resistant crops, like the pesticides used to control insects, force those insects to evolve resistance to the pesticide (in the case of B.t. crops, a "plant pesticide" encoding a protein in its leaves that will punch holes in a corn borer’s gut). The same selection pressures are present with herbicide resistant crops, with the added wrinkle of closely related weeds sometimes trying to borrow herbicide resistance genes from the crop they are invading.

While these target insect concerns continue to this day (with no "dominant" resistant insects appearing in the U.S., validating the management program), there are new concerns raised about non-target insects (innocent bystander butterflies or beneficial insect predators). Today, there is an ongoing controversy over impacts to the Monarch butterfly or the predatory lacewing from B.t. crops. While the United States Environmental Protection Agency (EPA) has declared the threat from B.t. to be minimal, activists are not known to be content with the EPA’s B.t. position. Non-target insects will be an issue for agricultural biotechnology to monitor carefully for years to come.

Labeling of Genetically Improved Crops
With the third Roundtable in May 1999, speakers returned to food products and Food and Drug Administration (FDA) policy controversy, leaving ecosystems to the EPA. Labeling of food produced from LMOs stands as one of the most controversial subjects in agricultural biotechnology. The FDA does not require labeling for food that poses no known allergy risks or other change in food characteristics. Consumer activists explained why the FDA had the authority and the obligation to mandate labels informing consumers of the use of LMOs. Industry speakers pointed out the slippery slope that would form if every media-hyped issue relating to food processing could become information mandated on labels. Food labels meant to carry information about safety could be cluttered with environmental, social, or overtly misleading messages.

Liability for genetically improved crops is an issue that the U.S. agricultural biotechnology industry takes very seriously. Industry stewardship programs have prevented adverse impacts to the environment or human health. As the Starlink™ fiasco in taco shells demonstrates, industry stewardship programs that have to segregate to a "zero tolerance" standard may require extensive fine tuning to work at that impracticably high level of segregation. As any experienced farmer can testify, "volunteers" from errant seeds are a common occurrence.

The non-governmental organizations that have made regular appearances at our Roundtables would take this vision of expanded industry stewardship even further, arguing that the agricultural biotechnology industry should account for broad socioeconomic impacts. If all new technology were required to "prove a negative" on safety and socioeconomic impacts before ever reaching the marketplace, we would have considerably less new technology. In the case of genetically improved crops, however, those seeking to apply the precautionary principle appear to be content for now with simply arresting innovation in one sector of agriculture – plant and animal breeding.

What Impacts Can We Expect from the Biosafety Protocol?
At the Section’s next Roundtable, we will once again feature leading authorities from science and policy to review the impact of new rules regulating GMOs, which are now known as LMOs under the terms of the Biosafety Protocol. Seed companies, growers, and the entire chain of agricultural commerce in the U.S. will need to implement "identity preservation" for crops and lines of communication that create an interdependent marketplace.

Thomas P. Redick is a vice-chair of the Section’s Special Committee on Agricultural Management and the Committee on Toxic Torts and Environmental Litigation.