The US regulatory scheme for biotechnology products relies on multiple agencies to implement a mosaic of existing federal statutes. Each statute has a specific goal, for example to protect public health and the environment or to ensure food safety. The mosaic approach was deemed appropriate by the coordinated framework to regulate the diverse new biotechnology products and to provide credible assessments that would form the basis of sound regulatory determinations without unduly hindering the development of the technology.
The success of the multiagency approach can be assessed relative to three objectives:
Transparency and public trust.
Scientific issues were addressed primarily in chapter 2 and chapter 3, but their relevance to coordination, transparency, and public trust will be addressed in the discussion that follows. Only through effective coordination can the three lead agencies—EPA, USDA, and FDA—minimize duplication, avoid inconsistent regulatory decisions, address potential gaps in oversight, ensure that regulations evolve with experience and scientific advances, and effectively review the human health and environmental safety of products. Ultimately, the credibility of the regulatory process will depend heavily on the public's ability to understand the process and the key scientific principles on which it is based.
The coordinated framework addresses several elements that contribute to a sound regulatory process. The committee has considered those elements and identified five that are most relevant to the immediate task (box 4.1).
The coordinated framework established several guiding principles to help the federal agencies coordinate their regulatory responsibilities. It states (OSTP 1986) that