Box 4.1

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.

The agencies will seek to operate their programs in an integrated and coordinated fashion and together should cover the full range of plants, animals and microorganisms derived by the new genetic engineering techniques….Agencies have agreed to have scientists from each other's staff participate in reviews.

Consistent with regulatory practice regarding traditional products, the 1986 framework called for jurisdiction over biotechnology products to be determined by their use. It identified the lead agency and supporting agencies that would be responsible for the oversight of various classes of products (table 4.1). The approach was explained as follows:

Where regulatory oversight or review for a particular product is to be performed by more than one agency, the policy establishes a lead agency, and consolidated or coordinated reviews.

Two other principles enunciated in the framework to promote coordination are that agencies should adopt, to the extent permitted by their statutory authorities, consistent definitions of the organisms subject to review; and that agencies should use reviews of comparable rigor. The authors of the policy also recognized that future scientific developments should lead to further refinements in the coordinated framework. They expected regulations to evolve as scientists and regulators gained experience in predicting which products required more or less controls.

EPA's 1994 proposed policy on pesticides subject to FIFRA and FFDCA discusses interactions with other agencies The policy makes EPA the federal agency primarily responsible for the regulation of pesticides and states that EPA works closely with USDA and FDA in fulfilling this



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