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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
the natural host range of the virus;
how the virus is transmitted;
if transmitted by a vector, the identity of the vector including mode of transmission (e.g., persistent or non-persistent);
whether any synergistic or transcapsidation interactions with other viruses under field situations have been reported in the literature; and
the location and the name of the host plant the virus was originally isolated from.
The above information can be provided in a table format. This information can be supplemented by listing references that report the host range, insect vectors, etc., for the virus.
III.Description of the Transformation System
For Agrobacterium-based transformation protocol, the applicant must indicate how Ti plasmid-based vector was disarmed (i.e., all tumorigenic DNA was removed). Applicants can provide citations that describe the transformation procedure. However, any significant modifications of transformation, strain designation, etc., should be described.
For other methods of transformation, the applicant can describe the sources of various components of the plasmid (or other DNA including possible carrier DNA) and method of transformation by citation. However, any significant modifications of transformation, strain designation, etc., should be described.
The applicant must provide a detailed restriction map of the plasmid that is sufficient to be used in the analysis of Southern data. Description of added restriction sites is helpful in the interpretation of Southern data and should be provided.
Indicate the functions of the gene(s), promoters, leader sequences, enhancers, introns, and any other sequences that are used for gene expression in the plant and a reference describing from where the sequences were obtained. Discussion should include whether the inserted sequences are responsible for disease or injury to plants or other organisms. The nucleotide sequence(s) of the plant-expressed gene(s) should be provided by citation and not submitted in the application. If there has been a significant modification to sequences and the modified sequence has not been published, they should provide the complete sequence highlighting the modifications. If there have been minor modifications to the sequence of the plant-expressed gene, they should be provided. For example, if in a chemically synthesized Bt gene amino acid 23 was changed from methionine to alanine, it should be stated without providing the complete sequence.