Regulatory agencies should aggressively seek to reduce regulatory costs for small biotechnology startup companies, small to medium size seed companies, and public sector breeders by providing flexibility with respect to data requirements, considering fee waivers wherever possible, and helping these parties navigate their regulatory systems.
The committee does not recommend waiving necessary regulatory requirements; however, where regulation is not warranted, agencies should look for appropriate opportunities to promote nonregulatory mechanisms to address issues associated with transgenic pest-protected plant products, including encouraging development of voluntary industry consensus standards and product stewardship programs.
In the time allotted for this report, the committee focused on providing meaningful input to improve the review of scientific data under the coordinated framework and the proposed EPA plant-pesticide rule. The committee's findings, conclusions, and recommendations will need to be tested before they are confirmed as useful methods to enhance scientific review during the regulation of transgenic pest-protected plants. The committee realizes that these improvements may not be possible without increased resources for the federal agencies involved in agricultural biotechnology and for research focused on the risks and benefits. A solid regulatory system and scientific base are important for acceptance and safe adoption of agricultural biotechnology, as well as for protecting the environment and public health. In general, the current US coordinated framework has been operating effectively for over a decade. However, the committee has identified several kinds of improvements that would be helpful in the face of a larger number of commercialized transgenic pest-protected plants and novel gene products introduced into these plants. Those improvements might be necessary for increased confidence in US agricultural biotechnology both domestically and worldwide.