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Regulation and Future Impacts

Who Monitors Biotechnology?

The federal government reviews safety and effectiveness of all new drugs, food additives and pesticides. This includes products made with classical biotechnology or with genetic engineering.

Agricultural biotechnology products may be regulated by a combination of three federal agencies: the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Together, these agencies are empowered by law to use three criteria when assessing new products: safety, efficacy, and quality. This means the agencies answer these questions for each new product: 1) Is the product sufficiently safe to humans and the environment? 2) Does the product work as intended? 3) Can the quality of the product be assured? Some people suggest that new products be reviewed by a fourth criterion: 4) What are the potential or probable social and economic impacts of the product?

New technologies often bring new legal, regulatory and ethical challenges. What you know about biotechnology will better prepare you to make personal choices and public policies about the use of new technologies and their products.

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