Legal and Advisory Frameworks


Legal Frameworks
Building Frameworks

Hierarchies exist in all activities, from simple naming species to determining which statute to rely on for regulating human activity (such as biotechnology) and define lines of authority. Regulations are promulgated by government agencies to define their roles in specific situations. Regulations are official requirements based on laws. The U.S. regulatory scheme for biotechnology products relies on multiple agencies to implement a mosaic of existing federal statutes. Each statute has a specific goal, e.g. to protect public health and the environment or to ensure food safety, pharmaceutical purity and sterility, lack of adverse environmental effect. The mosaic approach was deemed appropriate to regulate the diversity of new biotechnology products using existing statutes and to provide credible assessments to form the basis for sound regulatory determinations without unduly hindering the technology. In the US three US agencies have statutes which enable them to regulate biotechnology products: the Environmental Protection Agency (USEPA), the Department of Agriculture (USDA), and the Food and Drug Administration (FDA).

While all three agencies appear to have broad regulatory authority to cover transgenic pest-protected plants, USDA and EPA have elected to narrow their effective scope of coverage by exempting certain products. This is accomplished by promulgation of regulations (and policy statements) which define the scope of the agency's coverage. Scope definition requires much interagency coordination and an oversight body which ensures that there are no gaps. In addition to specifying what is covered, regulations specify the manner in which the governing body will examine the issue.

Generally, the scope of the investigation , the type of data and the precision required are defined by regulation. Regulations are difficult to amend, requiring legislative action for promulgation. Most agencies issue guidelines and policy statements to amend and/or interpret regulations.


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Last Modified: June 12, 2001
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