defers to EPA for evaluation of the pesticide component of transgenic pest-protected plants. FDA established guidance under the coordinated framework when it published its policy on novel foods in 1992 (FDA 1992). The policy provided direction to the regulated community and the public about when there was a need for consultation in lieu of submission of a food additive petition.
FDA has used its website to provide direction on how to use the policy to determine when a consultation should be used, what the expectations of the agency are for safety determinations, and how the consultation process works (FDA 1999a). The website also contains a list of completed consultations (FDA 1999b), which states the products and companies involved in the consultation.
However, the details of these consultations are not readily available for public scrutiny. If the public wants to obtain documents containing information and data submitted to FDA for consultation, they must request the documents from FDA through the Freedom of Information Act (FOIA). Processing and fulfillment of FOIA requests can often take a long time.
FDA maintains an internal database on the amino acid sequence of known human allergens that has been useful to both EPA and FDA in evaluating the potential allergenicity of plant-expressed pesticides and food additives. The database is not publicly accessible, thus making it more difficult for researchers and developers to assess allergenicity. FDA and EPA generally discuss how such information is used to assess allergenicity potential in the summaries of their evaluations (FDA 1999b). However, funding constraints might affect FDA's ability to maintain and update this database as new information becomes available.
FDA does not directly address the issue of substantiation of CBI claims for novel foods derived from biotechnology. Like EPA, FDA does not have an explicit relationship with state regulators in this arena (as USDA-APHIS has with its state counterparts), so a perspective on its screening of CBI claims is not possible.
The Internet has greatly enhanced agencies' ability to communicate their regulatory process to the regulated community and the public. The federal agencies involved in regulating transgenic pest-protected plant products have used this medium to varied degrees, as indicated above. However, although agencies provide cross-links to one another's resources (USDA 1999e), there is no current way to link the decisions that various agencies have made about individual plant products under their own statutes.
To improve transparency, the committee recommends that