Box 4.2

Information Requirements Common to all Agencies

  • Biology of recipient:

—information on taxonomy, habitat, and growth characteristics.

  • Molecular biology:

—description of source and identity of transforming material and mode of transformation.

  • Products of inserted material:

—identity, characterization, purpose, and mode of action.

  • Selectable markers:

—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 submit similar 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 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).

4.3.6 Comparably Rigorous Reviews

Agency decisions concerning transgenic pest-protected plants should



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