ES.7.1 Elements of an Effective Regulatory Framework

The committee finds that, operating under the coordinated framework, EPA, USDA, and FDA have successfully applied existing statutes to address the introduction of transgenic pest-protected plant products, but concludes that there is room for improvement. In particular, those agencies have achieved a significant degree of coordination in their oversight of transgenic pest-protected plants, but certain aspects of this coordination could be enhanced. Only through effective coordination can the three lead agencies minimize duplication, avoid inconsistent regulatory decisions, address potential gaps in oversight, and ensure that regulations evolve with experience and scientific advancements. Ultimately, the credibility of the regulatory process and acceptance of products of biotechnology depend heavily on the public's ability to understand the process and the key scientific principles on which it is based.

The committee identified five elements of an effective regulatory system which support the objectives of the coordinated framework (Box ES.1).

For example, to improve the transparency of the regulatory process under the coordinated framework, the committee recommends that

The quantity, quality and public accessibility of information on the regulation of transgenic pest-protected plant products should be expanded.

The USDA-sponsored coordinated framework database to link agencies ' regulations and decisions (USDA 1999e) is useful, but should be

Box ES.1

Elements that Support the Objectives of the Coordinated Framework

  • Consistency of definitions and regulatory scope.

  • Clear establishment of lead and supporting agencies with a mechanism for effective interagency communication.

  • Consistency of statements of information to support reviews.

  • Comparably rigorous reviews.

  • Transparency of review process.

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