Senator Richard Durbin (D-Ill.) has introduced a bill (S. 3095) that would amend the federal Food, Drug, and Cosmetic Act to “require premarket consultation and approval with respect to genetically engineered foods.” The Genetically Engineered Foods Act, which has been referred to the Committee on Agriculture, Nutrition, and Forestry, defines genetic engineering as “a transformation event,” i.e., one that involves “the introduction into an organism of genetic material that has been manipulated in vitro,” “to derive food from a plant or animal or to produce an animal.” Any producer of a genetically engineered food would be required to obtain FDA approval before introducing such food into interstate commerce. Such approval would require a determination that the food is (i) safe, (ii) safe under specified conditions of use, or (iii) not safe because the food “contains genes that confer antibiotic resistance,” “contains an allergen,” or “presents 1 or more other safety concerns.” An environmental assessment would be required with respect to the genetic engineering of animals. The Center for Science in the Public Interest apparently supports the legislation. See CSPI Newsroom, October 11, 2002.

Meanwhile, food industry representatives have reportedly met with the FDA, urging the agency to finalize draft guidance on voluntary labeling and a proposed regulation that would require food developers to notify the FDA about their intent to market a food or animal feed developed through biotechnology. Critics do not believe the guidance and rule are adequate, said a news source. The pressure for some regulation is growing as some 70 percent of products on grocery store shelves contain genetically engineered ingredients and, according to some studies, genetically engineered crops are saving U.S. farmers millions of dollars by decreasing the need for pesticides and herbicides. See Inside Washington Publishers, October 18, 2002; sfgate.com, October 21, 2002.

On another front, a biotechnology trade organization is apparently adopting a voluntary moratorium on planting certain types of crops in major food-producing areas. According to a news source, such crops involve plants with altered genes that can be used to produce medically useful proteins that may be unacceptable for general food use or could contaminate food crops on nearby farms. The policy is reportedly designed to prevent a repeat of the recent StarLink corn debacle that resulted in a genetically engineered corn intended only for animal feed spreading to corn used in food for human consumption. See washingtonpost.com, October 21, 2002.

Internationally, there is significant resistance to biotech foods. Press reports have indicated that Asian importers are resisting genetically modified wheat, while the European Union (EU) has failed to lift its four-year old moratorium on approving new genetically modified organisms. A sticking point for agriculture ministers is apparently whether to allow an unintentional presence of up to 1 percent of biotech material in a food product before requiring a warning label. The United States is reportedly considering a World Trade Organization challenge to the ban, which has cost corn growers alone some $200 million annually in lost exports. An EU directive, however, came into effect on October 18 that would apparently allow biotech companies to apply for approval of their products. Member states do not intend to give any such products approval, said a news source, until further labeling and traceability rules are in place. U.S. Trade Representative Richard Mills was quoted as saying, “it remains unclear whether [the directive] will lead to any real change.” See Reuters Company News, October 9, 2002; Greenwire, October 15, 2002; and just-food.com, October 18, 2002.

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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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