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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
Information Requirements Common to all Agencies
Biology of recipient:
—information on taxonomy, habitat, and growth characteristics.
—description of source and identity of transforming material and mode of transformation.
Products of inserted material:
—identity, characterization, purpose, and mode of action.
—identification and characterization.
ties have similar information needs (box 4.2): biology of recipient; molecular biology; products of inserted material; and selectable markers. These common needs might be a useful starting point for a harmonized list of data requirements. Although the agencies appear to prefer different levels of detail on these four subjects, the overall scope of information is virtually identical —an observation that the committee confirmed in meetings with EPA and USDA. Each agency needs this basic information to understand a product and conduct its assessment. The committee found that
Appropriately, EPA, USDA, and FDA request that applicants submitsimilar information concerning the recipient plant, molecular methods,characterization of gene products, and selectable markers.
The committee recommends that
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).
4.3.6 Comparably Rigorous Reviews
Agency decisions concerning transgenic pest-protected plants should