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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
EPA, USDA, and FDA should develop a joint guidance document for applicantsthat identifies the common data and information the three agenciesneed to characterize products (for example, biology of the recipientplant, molecular biological methods used to develop the product,identification and characterization of inserted genetic materialand their product(s), and identity and characterization of selectablemarkers).
The USDA database on FPPA decisions is particularly useful and user-friendly,and should serve as a model for the other agencies. The committeerecommends full funding for the maintenance of existing USDA databases.
EPA should make data evaluations readily available on its websiteor in response to written requests.
EPA pesticide fact sheets should be prepared with greater clarityand with more factual information to clearly and quantitatively presentthe results of safety testing.
EPA should promptly complete the process for issuing regulations,policies and guidance that set out the review and regulatory parametersfor pesticidal substances in transgenic pest-protected plants.
To fulfill the intent of the coordinated framework, a database tolink agencies' decisions for particular products would benefit awide array of interested parties that are following developmentsof agricultural biotechnology. Such a database would enhance theexisting information provided by the agencies and the overall credibilityof the framework. Alternative funding mechanisms should be exploredto maintain this database.
EPA, USDA, and FDA should require substantiation of CBI claims atthe time of data submission.
Regulatory agencies should aggressively seek to reduce regulatorycosts for small biotechnology startup companies, small to mediumsize seed companies, and public sector breeders by providing flexibilitywith respect to data requirements, considering fee waivers whereverpossible, and helping these parties navigate their regulatory system.