of the genetic modifications in the regulated articles under consideration and detailed comparison of the modifications in those regulated articles with those in the antecedent organism.” For organisms not covered in the APHIS examples above, the applicant may address why the particular organisms in question do not raise any issues different from those considered in the determination for the antecedent organism, thereby meriting separate consideration under a new petition.

Also, the requesters should provide information on the phenotypic expression of the genetic modifications in the regulated articles, indicating any expected or unexpected differences in phenotype between the regulated articles and their antecedent organism. Data from at least one field trial should be included, and all data reports from completed field trials with a regulated article should be submitted with the extension request.

CONCLUSION

APHIS regulation of transgenic organisms has evolved over the past two decades. To meet the growing number of field tests an expeditious notification system has evolved, assuring rapid turnover of field test applications. The permitting process, originally used for all field tests, is now used to deal with field testing situations that require substantial scrutiny (such as products intended for pharmaceutical use). Both the notification and permit processes require that transgenic organisms be grown and handled in such a way as to prevent their escape into the ambient environment. Petitions of the determination of nonregulated status (and a similar extension system) represent what has been the primary pathway to commercial plantation of transgenic plants. However, commercial products have also been created from regulated transgenic organisms that have been grown under notification and permit. It is not clear which of these regulatory pathways will become the option of choice for future field-based commercial plantations of transgenic plants.



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