tem” (OSTP/CEQ 2001). Notification for the movement, importation, and field testing of transgenic plants follows a rigid but streamlined format that allows an expeditious review. For a specified list of plants and characteristics, an applicant may simply notify APHIS of its intent to release a regulated article. Upon receipt of such a notification application, the document is logged into the APHIS database and reviewed by one of the scientific staff for qualification and completeness, and then a recommendation is sent to appropriate state officials for concurrence. The entire process must be completed within 30 days (10 days for interstate movement). Scientific evaluation of a notification application by APHIS personnel is typically completed within a few days. Acknowledgment by APHIS that an article meets the notification requirements means that a permit is not required for field testing within one year of the date of introduction. Renewal can be accomplished by submitting an additional notification to APHIS.
The assessment of notifications is not subject to external scientific review or any other public input. A few transgenic plants are now grown to produce commercial products under notification.
To meet APHIS criteria for notification:
The plant must not be listed as a noxious weed under the Federal Noxious Weed Act or be considered to be a weed in the area of release into the environment.
The inserted DNA must be stably integrated into the host genome. According to the user’s guide (APHIS 1997bs), this means that the trait is inherited in a Mendelian fashion for at least two generations.
The function of the inserted DNA is known, and its expression does not result in plant disease. Function is not precisely defined in the user’s guide, but the intent of this criterion is that expression does not result in plant disease.
The inserted DNA does not
cause production of an infectious entity;
encode substances that are known or likely to be toxic to nontarget species known or likely to feed on the plant (According to the user’s guide, toxicity to non-target species is restricted only to those nontarget species that feed on the plant, not dispersed plant parts, such as seeds, pollen, or plant residue.);
encode products intended for pharmaceutical use. (According to the user’s guide, “intention” becomes clear for regulatory purposes only when clinical testing of the product is proposed to the Food and Drug Administration. Until such time, a product is not considered to be intended for pharmaceutical use.)