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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
geographic basis within the United States. This inconsistency is important because in one case the perceived inability of APHIS to set geographic limits led it and the Environmental Protection Agency (EPA) to make different decisions on the planting range of transgenic cotton in the United States. There may be future situations where at least temporary geographic limits would be beneficial.
Current APHIS oversight involves three processes: notification, permitting, and petitioning for nonregulated status. It is possible to commercialize the nonliving products of transgenic plants through each of these processes, but petitioning for nonregulated status is currently the predominant mode for commercialization of all transgenic plant products and is the only process for commercialization of living transgenic plants. Initially, all field testing of transgenic plants needed to be approved by the permitting process (see Chapter 3). However, APHIS determined that for some transgenic plants, safety could be assured through a more streamlined approach of having the applicant notify the agency in advance of planting. The notification process was first used for a limited set of crops, but currently almost all field testing is conducted through the notification process that requires APHIS to complete its decision making in less than 30 days. Within this time frame, one APHIS staff member typically determines if the notification process is sufficient for the particular transgenic plant. The applicant must follow general guidelines to ensure that there are no environmental effects from the planting, but the process involves no public or external scientific input. Plants that cannot be grown in the field, based on notification, include those that produce substances intended for use as pharmaceuticals and those that could affect non-target organisms. Some plant products have been commercialized using the notification process, and there is no limit to the acreage that can be planted under the notification system. Commercialization of certain plant products through notification could result in large plantings and increased risks through scale effects. In the committee’s examination of specific cases where commercialization involved only oversight through the notification process, one case was found where it appears that a transgenic plant with toxic properties (avidin-producing corn) was grown under the notification process. The committee finds that the notification process is conceptually appropriate, but there is a need to reexamine which transgenic plants should be tested and commercialized through the notification process.
In comparison with the notification process the permitting process requires more detail from the applicant, and if APHIS determines that there is a need for a formal Environmental Assessment of the plant, a description of the application is published in the Federal Register and is open to public comment. The permitting process is not commonly used at