EPA, USDA, and FDA should develop a joint guidance document for applicants that identifies the common data and information the three agencies need to characterize products (for example, biology of the recipient plant, molecular biological methods used to develop the product, identification and characterization of inserted genetic material and their product(s), and identity and characterization of selectable markers).
The USDA database on FPPA decisions is particularly useful and user-friendly, and should serve as a model for the other agencies. The committee recommends full funding for the maintenance of existing USDA databases.
EPA should make data evaluations readily available on its website or in response to written requests.
EPA pesticide fact sheets should be prepared with greater clarity and with more factual information to clearly and quantitatively present the results of safety testing.
EPA should promptly complete the process for issuing regulations, policies and guidance that set out the review and regulatory parameters for pesticidal substances in transgenic pest-protected plants.
To fulfill the intent of the coordinated framework, a database to link agencies' decisions for particular products would benefit a wide array of interested parties that are following developments of agricultural biotechnology. Such a database would enhance the existing information provided by the agencies and the overall credibility of the framework. Alternative funding mechanisms should be explored to maintain this database.
EPA, USDA, and FDA should require substantiation of CBI claims at the time of data submission.
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 system.