To fulfill the intent of the coordinated framework, a database to link agencies' decisions should be developed to benefit a wide array of interested parties that are following developments in agricultural biotechnology. Such a database would enhance the information now provided by the agencies and the overall credibility of the framework. Alternative or varied funding mechanisms should be explored to maintain this database.

The above database should expand on the existing USDA-sponsored coordinated framework database (USDA 1999e) to include more public information about specific products and to link agencies' decisions about specific products.

With respect to CBI and public access to information, the committee found that

Consistent with protections afforded by law to trade secrets and CBI, agencies have made a considerable amount of information on product reviews and approvals available but there is room for improvement.

The committee recommends that

EPA, USDA, and FDA should require substantiation of CBI claims at the time of data submission.


The impacts of the coordinated framework are likely diverse and difficult to characterize and quantify. Potential benefits associated with the regulation of transgenic pest-protected plants include increased health and environmental safety and consumer confidence. Direct costs of regulation include expenditures on additional testing (that is, above and beyond testing that would occur in the absence of regulation) and employee time spent overseeing the regulatory process and interacting with agencies' staff. They also include costs associated with delays in development and commercialization of products. If those direct costs are sufficiently high, they can increase the potential size of the market (expected sales) needed to break even and thus justify investment in a new plant variety. As a result, some crop varieties (in particular minor crop varieties) may not be developed.

The committee reviewed an analysis of the costs associated with the regulation of pest-protected plants which was authored by one of its mem -

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