HAU16008-08-5 - F E AT U R E Are Bt crops safe Mike...

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F E AT U R E NATURE BIOTECHNOLOGY VOLUME 21 NUMBER 9 SEPTEMBER 2003 1003 Bacillus thuringiensis ( Bt ) is a naturally occurring soil bacterium that produces pro- teins active against certain insects. Beginning in the mid-1990s, crop plants expressing Bt genes were commercialized in the United States. Cry1Ab and Cry1F Bt corn are effective in controlling certain pests of corn (European corn borer, corn ear- worm and southwestern corn borer), and Cry1Ac Bt cotton is effective in controlling certain pests of cotton (tobacco budworm, cotton bollworm and pink bollworm). Beyond the economic benefits to growers, the use of Bt corn and Bt cotton result in less risk to human health and the environment than chemical alternatives. In 2001, the US Environmental Protection Agency (EPA; Washington, DC, USA) reassessed the four still registered, but expir- ing, Bt crops that had been accepted for agricultural use in the preceding six years (from 1995 to October 2001; Table 1 ). The Bt crop reassessment approvals included provisions to prevent gene flow from Bt cot- ton to weedy relatives, increase research data on potential environmental effects and strengthen insect resistance management. From this reassessment, the EPA has determined that Bt corn and Bt cotton do not pose unreasonable risks to human health or to the environment. In this article, we summarize the supporting data and con- clusions of the EPA. The complete reassess- ment document 1 , Biopesticides Registration Action Document (BRAD)—Bacillus thuringiensis Plant-Incorporated Protectants , which describes in detail the reassessment process, along with extensive references, can be found on the EPA website at h t t p : / / w w w . e p a . g o v / p e s t i c i d e s / biopesticides/pips/bt_brad.htm . Federal oversight of Bt crops Consistent with the Coordinated Framework for Regulation of Biotechnology issued by the US Office of Science and Technology Policy in 1986 (51 FR 23302), genetically engineered (GE) crops with pes- ticidal traits fall under the oversight of the EPA, the US Department of Agriculture (USDA; Riverdale, MD, USA) and the US Food and Drug Administration (FDA; Rockville, MD, USA). Using a voluntary consultation process, FDA determines whether foods and animal feeds developed from GE crops with pestici- dal traits are as safe as their conventional counterparts. It does this by determining whether the companies producing them have answered all the appropriate questions about the new plant varieties, such as whether new allergens are present and whether there are increased levels of natural toxicants or perhaps reductions of impor- tant nutrients. Any changes in nutritional properties or crop processing or the pres- ence of new allergens could require labeling to inform consumers of the important changes to the food or feed.
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