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.
