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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
Any virus-derived sequences must be known noncoding regulatory sequences or otherwise unlikely to facilitate virus virulence and spread in plants.
The inserted sequence must not be derived from human or animal viral pathogens or other potential human or animal disease-causing agents.
In addition to meeting these criteria, introductions under the notification system must meet specified performance standards designed to ensure such confinement that the transgenic plant or its progeny will not unintentionally persist in the environment.
The standards state general concerns but leave applicants the flexibility to meet them according to their own circumstances:
The transgenic plant must be transported and stored in a way that minimizes the escape of viable plant parts into the environment. According to the APHIS user’s guide, this performance standard refers to seeds, cuttings, buds, and other plant parts that would be planted to grow the crop but not the movement of pollen.
For environmental release, inadvertent mixing of the transgenic plant with nonregulated plant material must be avoided. According to the APHIS user’s guide, this performance standard refers to seeds, cuttings, buds, and other plant parts that would be planted to grow the crop but not the movement of pollen.
The identity of the transgenic plants and their parts must be maintained; plants and their parts must be contained or devitalized after use. According to the APHIS user’s guide, this performance standard does not cover the movement of pollen.
There must be no pathogenic vector associated with the plant.
Field trials must be conducted in a manner that precludes persistence of the plant and its progeny.
Management practices to prevent persistence of the plant or its progeny in the environment must be applied.
APHIS provides detailed guidance for notification applications in its user’s guide including sample notification letters and guidance on how to meet performance standards. The notification application consists of the name and identity of the responsible person (applicant) and a description of the regulated article. The description must include the identity of the transformed plant species, the method of gene transfer, and a full description of the inserted sequences, including the functions, encoded proteins, and source donor organisms for each segment. In addition, the notification application must include, for field releases, the geographic details, size, and duration of field trials and, if appropriate, information about