4.3.7 Transparency of Review Process
Background

The degree to which regulatory agencies make their regulatory processes transparent influences the acceptance of a regulatory program. Transparent regulatory processes provide a clear basis for regulatory coverage, provide clear direction to those who must comply with regulations, and assist the public in understanding how the process is intended to work. Public trust in the regulatory process is gained through transparency. When the regulatory process is applied to situations where the scientific underpinnings of the technology and its impacts are continuing to evolve, transparency is crucial to identifying how scientific knowledge is being applied in the regulatory process. One of the challenges to transparency in a regulatory process is identifying the degree to which a regulatory agency needs to protect the legitimate trade secrets of the regulated community.

From a general perspective, the coordinated framework, as implemented by the various federal agencies, has elements of transparency, but there is considerable variability among the agencies. Under the programs administered by the federal agencies implementing the framework, products of biotechnology have been commercialized in diverse sectors of the economy, and there has been reasonable public acceptance of the technology. This level of acceptance suggests public trust in the American regulatory system generally and other factors such as confidence in American agriculture to produce a safe food supply. That confidence contrasts with the skepticism concerning genetic engineering in general in Europe and other parts of the world (Layman 1999; Prakash 1999). Where public trust in the current framework appears to be fragile, lack of transparency in the process can be an exacerbating factor.

The strengths and weaknesses of the framework for regulation of transgenic pest-protected plant products can be examined in the context of a transparent regulatory process. The following analysis examines the transparency of the regulatory approaches taken by the three lead federal agencies from the standpoint of the regulated community, the state-level coregulator, and the public at large. The committee found that in general,

Ready access to information on product reviews and approvals and a meaningful opportunity for stakeholder participation are critical to the credibility of the regulatory process.



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