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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
The producers of the products also voluntarily engaged in consultations with FDA pertaining to the safety of the foods derived from the plants.
There are opportunities for interagency coordination during at least two stages of the regulatory process for transgenic pest-protected plant products. The first comes early in the process, when the developer is discussing the prospective product with the regulatory agencies to determine the kinds of data and information that will be necessary to support the regulatory review. These discussions are referred to as presubmission consultations and are encouraged by all three agencies. This is often the time when unique aspects of the product are discussed. A new product could raise jurisdictional questions or a need for new or different approaches to product testing or risk assessment.
Issues associated with new transgenic pest-protected plants might be of interest to more than a single agency. For example, a product consisting of a crop-gene combination that could result in gene flow and pose a potential human or environmental impact might raise legitimate issues for EPA or USDA and possibly for FDA as well. Interagency discussions at this early stage could help to avoid problems and delays later. To the committee's knowledge, the agencies have not yet interacted with one another on product-specific issues at this stage of the regulatory process.
Although such interaction would appear to benefit all parties, there could be several reasons for the apparent lack of activity. One reason might be that the product is highly confidential at this early stage of development and the producer prefers to work with each agency separately before submission. If that is the case, agencies might be unable to interact without the producer's permission because of legal constraints on the sharing of trade secrets and other confidential business information (CBI).
A second opportunity for interagency coordination is the period during formal product review, when the agencies are formulating their regulatory decisions on a product. Successful coordination during this period requires an effective infrastructure within and between agencies that promotes and rewards cooperative interaction. In being consistent with CBI requirements, all agencies attempt to provide each other with as much information as possible to facilitate communication on issues of mutual concern. EPA has taken steps to clear representatives of other agencies for access to CBI in submissions made to EPA. The ability of agencies to communicate unencumbered by CBI constraints can only enhance the credibility and public acceptance of the regulatory process.
Effective interagency coordination relies on a high degree of consistency in definitions, regulatory scope, and technical guidance of applicants, as well as effective communication and transparent review processes of comparable rigor (box 4.1). Several of those elements are