With Monsanto's withdrawal of its application to deregulate and commercialize the GE wheat, no GE wheat varieties have been approved by the U.S. Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS), the principal regulator of GE plants released into the environment. Preliminary tests by a scientist at the university indicated the possible presence of GE glyphosate-tolerant wheat plants. On May 3, the scientist notified APHIS of the preliminary test results, and APHIS began a formal investigation. Subsequent test results by APHIS indicated the presence of a glyphosate-tolerant wheat variety tested by Monsanto under APHIS approval at approximately 100 field trials in 16 states between 1998 and 2005. The agency had approved field testing of GE wheat in Oregon in 2001, but not on the site where the rogue GE wheat was discovered. APHIS also obtained samples of the producer's wheat harvests, including a sample of the producer's 2012 harvest. None of these samples of seed and grain tested positive for the presence of GE material. FDA has regulatory authority under the Federal Food, Drug, and Cosmetic Act for the safety and nutritional quality of GE foods and feeds. APHIS regulates the importation, interstate movement, and field testing of GE plants and organisms that are or might be plant pests under the Plant Protection Act (PPA; 7 U.S.C. 7701 et seq.). 151 et seq.). FDA completed a voluntary consultation on the safety of food and feed derived from the glyphosate-tolerant GE wheat in 2004, and agreed with Monsanto that the GE wheat was not "materially different in composition, safety, or any other relevant parameter from wheat now grown, marketed, and consumed." The United States exports about 50% of its wheat crop, and Oregon exports nearly 90% of its wheat crop. APHIS stated in June 2013 that there was no evidence that GE wheat had entered commerce. Initial tests of wheat imported by Japan, Korea, and the European Union found no evidence of the unapproved GE trait. Many countries have zero-tolerance policies regarding imports of unapproved GE varieties. After the announcement of the GE wheat discovery, Japan (the largest buyer of U.S. wheat) and South Korea temporarily suspended new purchases of U.S. soft white wheat grown in Oregon and the Pacific Northwest. APHIS Final Report on the GE Wheat Discovery and a New Investigation of GE Wheat Discovered in Montana

In September 2014, APHIS announced that its investigation of the Oregon incident was closed, and the agency released its findings. However, APHIS stated that it was unable to determine precisely how the GE wheat came to be growing in the single Oregon field. Monsanto Settlement Agreement Regarding the Oregon GE Wheat

In November 2014, Monsanto reached a settlement with U.S. wheat farmers who had sued the company. While not admitting liability, Monsanto agreed to pay a total of $250,000 to several wheat growers' associations. Monsanto also will pay $2.1 million into a settlement fund for soft white wheat farmers in Washington, Oregon, and Idaho who sold wheat between May 30, 2013, and November 30, 2013. The settlement also reimburses plaintiff's attorneys for costs associated with the litigation. As part of the settlement, three pending class action suits will be dismissed. In September 2014, a different variety of Monsanto's GE wheat was also discovered growing in a Montana field. The incidents are also likely to continue fueling criticism of those opposed to GE crops in general, and who question the strength and reliability of APHIS's regulatory oversight of the introduction of GE plants into the environment.
The U.S. Department of Agriculture (USDA) announced on May 31, 2013, that a variety of genetically engineered (GE) wheat had been discovered in a field in eastern Oregon. No varieties of genetically modified wheat have been approved, or deregulated, by the Animal Plant and Health Inspection Service (APHIS), the USDA agency responsible for regulating the release of GE plants into the environment. Release of GE plants into the natural environment is regulated by APHIS under the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.), as amended.
APHIS began a formal investigation in early May after notification by an Oregon State University scientist that preliminary tests of the wheat samples from the Oregon farm indicated the possible presence of GE glyphosate-tolerant wheat plants. Test results by APHIS indicated the presence of a variety tested by Monsanto Company under APHIS approval at approximately 100 field trials in 16 states between 1998 and 2005. The agency approved field testing of GE wheat in Oregon in 2001, but not on the field where the rogue GE wheat was discovered. In its September 2014 report on the investigation, APHIS stated that the incident was isolated to the one field, but they were unable to determine how the GE wheat came to grow in the field. A recent discovery of another variety of GE wheat in Montana was publicly reported in September 2014. A new APHIS investigation of this unauthorized wheat began in July.
The safety of GE organisms for food and feed is regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). A voluntary consultation on the safety of food derived from the Monsanto GE wheat variety was completed by FDA in 2004. FDA had determined that this GE wheat variety was as safe for food and feed as non-GE wheat, and that there were no public health concerns.
In its September report, APHIS stated that there was no evidence that GE wheat had entered commerce. Initial tests of wheat imported by Japan, South Korea, and the European Union in June 2013 found no evidence of the unapproved GE trait. APHIS sampled 100 businesses that sold or purchased certified seed planted in the Oregon field. APHIS also obtained samples of the producer's wheat harvests, including a sample of the producer's 2012 harvest. None of these samples of seed and grain tested positive for the presence of GE material.
The presence of GE wheat in the market could have had significant trade implications if the variety turned out to be widespread. That has not been the case, and the trade implications were minimal. The United States is a major wheat exporter, exporting about 50% of its wheat crop. About 90% of Oregon's wheat crop is exported. Many countries, including Japan, the European Union, and South Korea, have zero-tolerance policies regarding imports of unapproved GE varieties. Japan, the largest buyer of U.S. wheat, and South Korea temporarily suspended new purchases of U.S. soft white wheat grown in Oregon and the Pacific Northwest. Those purchases have resumed.
In November 2014, Monsanto reached a settlement with U.S. wheat farmers who had sued the company. While not admitting liability, Monsanto also agreed to pay $250,000 to several wheat growers' associations. Monsanto also will pay $2.1 million into a settlement fund for soft white wheat farmers in Washington, Oregon, and Idaho, and will reimburse plaintiff's attorneys for costs associated with the litigation. As part of the settlement, three pending class action suits will be dismissed.
The Oregon and Montana incidents are likely to continue fueling criticism of GE crops in general and the efficacy of APHIS regulatory oversight.