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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
of a regulated article outside the constraints of physical containment that are found in a laboratory, contained greenhouse, or a fermenter or other contained structure” (APHIS 1987). For example, growing regulated articles in a controlled greenhouse would not constitute a release, but growing them in a standard greenhouse would.
When a regulated article is determined to have “nonregulated status,” it no longer is subject to APHIS oversight, but the agency has the option of taking action on any plant that it believes to present a plant pest risk as long as they have not determined it to have nonregulated status. In this case the article has been evaluated, and determined with a reasonable degree of certainty not to present risk as a plant pest, and APHIS cannot regulate it under FPPA or FPQA.
In 1987 APHIS published regulations for the release of transgenic organisms into the environment (APHIS 1987). These were modified in 1988 and 1990 to exempt Escherichia coli strain K-12, sterile strains of Saccharomyces cerevisiae, asporogenic strains of Bacillus subtilis, and Arabidopsis thaliana from permitting requirements for interstate movement under specified conditions (APHIS 1988, 1990) and again in 1993 and 1997 to provide a notification procedure and a process to petition for nonregulated status (APHIS 1993, 1997a).
The rules and their revisions are promulgated under the statutory authority of the FPPA and FPQA, which grant APHIS broad powers to regulate potential plant pest risks. APHIS must grant a permit for the introduction of any regulated article. Although there are several fine distinctions in its definition (see BOX 3.1), a regulated article is a genetically engineered organism that is or contains genetic material from one of many taxa listed in 7 CFR 340.2 or that meets the definition of a potential plant pest. The definition of “plant pest” is discussed in more detail below. Anyone wishing to “introduce” such an organism must request a permit from APHIS. APHIS has streamlined the permitting process for most transgenic plant species under specified conditions; for these, formal notification of APHIS in advance of a release is often sufficient for obtaining permission to introduce the transgenic plant. In addition, APHIS has developed a process whereby an applicant can petition the agency to determine that a transgenic organism does not pose a plant pest risk and is therefore no longer a regulated article subject to APHIS regulatory oversight.
The coordinated framework explicitly provides that federal agencies should focus on the characteristics of risks posed by a biotechnology product, not on the process by which it is created, but APHIS uses the process of genetic engineering to trigger oversight. As discussed in Chapter 2, APHIS has argued that it was not treating genetically engineered organisms differently from so-called established plant pests or naturally occur-