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Bt10 SLIPS INTO THE STREAM OF COMMERCE
Phill Jones
July, 2005 Last March, Swiss agbiotech company Syngenta AG announced that it had accidentally sold U.S. farmers an unapproved type of genetically modified (GM) corn seed. And it had done so for four years. Farmers could have planted approximately 37,000 acres of the GM corn, according to the company’s estimate. How did this happen? Syngenta had developed two strains of corn, Bt10 and Bt11, engineered to express Bacillus thuringiensis toxin protein as a pesticide. The company obtained approval to sell Bt11 for food and feed use and for cultivation in the United States, Canada, Argentina, Japan, South Africa, and Uruguay. Syngenta also acquired approval for food and feed use in the European Union, Switzerland, Australia, New Zealand, Taiwan, the Philippines, China, Russia, and Korea. Somehow, Bt10 seeds—retained for research—became inserted into five Bt11 seed production lines, which were sold to U.S. farmers beginning in 2001. The error surfaced after the company overhauled its quality control program to screen products with a DNA-based test, instead of relying on field observations and examinations of certain proteins. The Bt10 contamination probably eluded earlier tests for a simple reason: Bt10 and Bt11 are difficult to distinguish. Physically identical, Bt10 and Bt11 express the same Bt toxin protein and contain a herbicide tolerance marker gene for selection. Although Bt10 has an extra, inactive antibiotic resistance marker gene, Syngenta says the main difference between Bt10 and Bt11 is that their genomes contain novel genes in different chromosomal locations. After the discovery of the mix-up, Syngenta informed the Environmental Protection Agency, the Food and Drug Administration, and the U.S. Department of Agriculture. This was in mid-December 2004. By the end of March 2005, the EPA and USDA concluded that Bt10 contamination does not raise concerns about the environment or human and animal health. All Bt10-tainted plantings and seed stock have been identified and destroyed or otherwise contained. Farmers must buy new Bt11 corn seed every year, so Bt10 should not be sown again. Yet a lingering problem remained. Syngenta suggested that Bt10 might have slipped into the food supply and international export channels. It had. In early April, a European Union representative told reporters that about 1,000 tons of food and feed products containing Bt10 are thought to have entered the food chain in Europe. It wasn’t until late March that the European Commission learned about the Bt10 error, a delay that increased aggravation with the United States over GM crops. EU Member States backed a Commission proposal to require U.S. corn gluten feed and brewers grain to be certified Bt10-free. Since a validated Bt10 detection method did not yet exist, the new measure acted as a ban until EU regulators approved a new test. By the end of April, the EU’s Joint Research Center did endorse a new DNA-based test for the unauthorized Bt10 and ended the short-lived ban. Now, shipments of U.S. maize gluten feed and brewers grain must include an analytical report concluding that the product does not contain Bt10. By May 29, about 290 tests for Bt10 had been conducted on EU-bound maize products. One test caught a contaminated shipment of Ireland-bound corn gluten feed, and U.S. officials sent a warning before the ship arrived. Irish authorities took steps to ensure that the consignment would not enter the feed chain. Around the same time, an American shipment tainted with Bt10 cropped up in Japan, the biggest buyer of U.S. corn. Japanese officials promised to test every U.S. vessel when it arrived and asked the United States to conduct its own tests of corn shipments before they left port. Although the United States requested a one percent tolerance threshold for Bt10 contamination, the Japanese government allows no exceptions to the zero tolerance rule on crops for human consumption. Allocating responsibility with a baseball bat Strict liability theory could provide a solution for assigning responsibility. Strict liability is a type of liability without fault in which a person engages in an "abnormally dangerous" activity. Factors that a court may consider in determining whether an activity is abnormally dangerous include whether the activity involves a high degree of risk of harm, whether the gravity of the harm that may result from the activity is likely to be great, and whether the activity carries risk that the exercise of reasonable care cannot eliminate. A legislature can also define a certain type of activity as one evoking strict liability. In 2005, California Assemblyman John Laird (D-Santa Cruz) introduced the Food Integrity and Farmer Protection Act, which would enable farmers to collect damages for an unintentional contamination with GM crops. The manufacturer of a GM plant or seed would be liable for the contamination of a farm product, facility, or other property of any farmer, grain and seed cleaner, handler, or processor. The law would supply a manufacturer with a defense if a farmer or another party caused the contamination deliberately or by gross negligence. The bill is on hold until 2006. Other states have tread down this path. The Vermont Senate, for instance, approved similar legislation in April ("Liability Resulting from the Use of Genetically Engineered Seeds and Plant Parts"). If enacted, GM seed manufacturers would be liable for any damages suffered by farmers. Yet the House Agriculture Committee voted unanimously in May against bringing the bill to the full House. Massachusetts and Hawaii legislatures also introduced strict liability bills in 2005. Neither passed muster. Why do lawmakers show so little enthusiasm for strict liability? Earlier this year, the Montana Senate mulled over legislation that would make manufacturers of GM wheat seed liable for damages resulting from the seed’s introduction into the state. Opponents of the bill, including two of Montana’s largest farm groups, argued that such a law would discourage companies from bringing genetically improved seed to Montana. A representative of the Montana Grain Growers Association asserted that, if enacted, the legislation would create a moratorium on the development of new technology for the state. Others voiced concern that the law would chill seed research by start-up companies and at Montana State University. "Probably dead" is the official status of the bill. A strict liability bill also came up for discussion in the Hawaiian Senate this year; it has been deferred indefinitely. Echoing arguments from Montana, the state Board of Agriculture opposed the bill, arguing that it would limit the state’s ability to explore new technology. When Vermont Senator Robert Starr (D-Essex/Orleans) discussed his state’s GM crop contamination legislation with the Times Argus, he said that "the dog in this bill is strict liability." Starr compared an implementation of the strict liability provision to "killing a fly with a baseball bat." Legislators appear unwilling to accept the possible consequences of a strict liability law as a means to protect farmers. An alternative to assigning costs for a realized risk of GM crop contamination would be to minimize the risk in the first place. The USDA issued several penalties to Syngenta for the Bt10 affair: a $375,000 fine for moving Bt10 material through interstate commerce without a permit, and a requirement for the company to sponsor a training conference on compliance with USDA biotech crop regulations. One of the conference goals is to develop best management practices that should prevent contamination of novel genes from GM plants. If such standards were devised, then simple negligence may suffice to allocate responsibility for any future GM crop contamination. Selected Sources Macilwain C. US launches probe into sales of unapproved transgenic corn. Nature. March 22, 2005. Available at: http://www.nature.com Porter L. Senate passes GMO liability bill. Times Argus. April 6, 2005. Available at: http://www.timesargus.com Rosenwald MS. Syngenta says it sold wrong biotech corn. The Washington Post, page E01, March 23, 2005 Walker S. US has not agreed to corn tests for Japan. Reuters. June 2, 2005 Phill Jones BiotechWriter.com |