The GAO, which serves as the investigative arm of the U.S. Congress, has released a report that analyzes federal oversight of genetically engineered (GE) crops and recommends steps the agencies could take to better address the unauthorized release of these crops into food, animal feed or the environment. Titled Genetically Engineered Crops: Agencies Are Proposing Changes to Improve Oversight but Could Take Additional Steps to Enhance Coordination and Monitoring, the 109-page report discusses the roles that the U.S. Department of
Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) play in regulating GE crops. It also notes how six unauthorized releases of GE crops in recent years may not have adversely affected human or animal health, but did result in lost trade opportunities.

The GAO’s assessment was undertaken at the request of Senators Tom Harkin (D-Iowa) and Saxby Chambliss (R-Georgia), the chair and ranking member respectively of the Committee on Agriculture, Nutrition, and Forestry. In its report transmittal letter to the senators, the GAO notes, “Currently, the United States accounts for about 50 percent of the GE crops planted globally. In 2008, GE varieties accounted for about 80 percent of the corn, 92 percent of the soybeans, and 86 percent of the cotton planted in the United States. In 2005, GE varieties accounted for about 93 percent of the canola . . . Food industry sources indicate that over 70 percent of processed foods sold in the United
States contain ingredients and oils from GE crops.”

According to the report, “USDA and FDA do not have a formal method for sharing information that could enhance FDA’s voluntary early food safety review for certain GE crops in the field trial stage and support USDA’s oversight. Also, the three agencies do not have a coordinated program for monitoring the use of marketed GE crops to determine whether the spread of genetic traits is causing undesirable effects on the environment, non-GE segments of agriculture, or food safety, as recommended by the National Research Council and others.”

In light of the purported shortcomings identified and the potential risks posed by the spread of plant genetic material in the environment, the report recommends that “FDA post on its Web site the results of its early food safety evaluations, and that USDA and FDA develop a formal agreement to share information concerning GE crops with novel genetic traits that could cause, or are likely to cause, health concerns if unintentionally released into the food or feed supply. We are also recommending that USDA, EPA, and FDA develop a coordinated strategy for monitoring the marketed use of GE crops for unintended consequences to the environment, non-GE segments of agriculture, or food safety.”

According to the GAO, most of the stakeholders consulted in the preparation of its report “told us that future unauthorized releases of low levels of regulated GE material are likely to occur” in light of “the porous nature of biological systems and the potential for human error.” Harkin reportedly said in a prepared statement, “When unapproved genetically engineered crops are detected in the food and feed supply, food safety concerns rise, markets are disrupted and consumer confidence falls. I urge the agencies to implement GAO’s recommendations.”
The Center for Science in the Public Interest also supported the recommendations, saying in part,“[u]ploading decision documents to the Web should simply be normal operating procedure.” See Center for Science in the Public Interest Press Release, December 5, 2008; Product Liability Law 360 and Reuters, December 8, 2008.

In a related development, the FDA, EPA and USDA released a joint statement on December 3 to announce that “there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton.” The accidental release was apparently reported voluntarily by the Monsanto Co. According to the government’s statement, “This unauthorized GE cotton variety produces a pesticide that is a plant-incorporated protectant (PIP) nearly identical to the registered product already in a marketed corn variety. EPA and FDA have concluded that there are no food or feed safety concerns related to this incident. Also, if animals had consumed meal made from the unauthorized GE cotton variety, there would be no
residues in the meat, milk or eggs. Additionally, USDA has determined that the unauthorized GE cotton poses no plant pest concerns.”

Meanwhile, the European Union’s highest court has reportedly fined France US$12.9 million for failing to update its laws on genetically modified crops and foods. The country is required under EU law to adopt a 2001 directive that regulates how these crops may be grown and approved, from the cultivation of the seeds to importation of genetically modified products and their processing for industrial uses. See Reuters, December 9, 2008.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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