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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
pests. Building on that system, which has been in effect for many years, USDA issued rules in 1987 designed specifically to regulate genetically modified organisms before their release into the environment or movement in commerce (USDA 1987). Those rules prohibited the introduction of so-called regulated articles without a permit from the USDA Animal and Plant Health Inspection Service (APHIS). The process typically has been used to address small-scale field testing of genetically modified plants before commercialization, and it now requires either a permit for or advance notification of the test.
Under the USDA rules, a permit is required for (1) any organism altered or produced through genetic engineering if the donor or recipient organism either (a) belongs to a group of plant pests listed in 7 C.F.R. § 340.2 or (b) is an unclassified organism and/or an organism whose classification is unknown, (2) any product that contains a listed plant pest or unknown/unclassified organism, or (3) any other organism or product altered or produced through genetic engineering that USDA determines to be or has reason to believe is a plant pest (as defined by 7 C.F.R. § 340.1). The rules define genetic engineering as genetic modification of organisms by rDNA techniques. The rules do not regulate research with genetically modified organisms in a laboratory or contained greenhouse but come into play only when a person seeks to introduce genetically modified organisms into the environment or interstate commerce.
USDA has issued some 887 permits for genetically modified organisms since the program began in 1987, primarily for limited field tests involving crop plants (USDA 1999f).2 On the basis of its experience with the permit program, USDA has provided a number of exemptions for articles that it has determined do not pose a plant pest risk. One of the more important exemptions authorizes the introduction of certain regulated articles without a permit provided that USDA is notified in advance. To qualify for the notification process, a regulated article must be one of the plant species identified in the rule and must meet six eligibility criteria (for example, introduced genetic material must not cause the introduction of an infectious entity) and six performance standards (for example, field trials must be conducted so that regulated articles will not persist in the environment) (USDA 1987, section 3b). In the notification process, USDA must either acknowledge that notification is appropriate for the designated introduction activity (import, interstate movement, or environmental release) or deny permission for introduction and require a permit (USDA 1987, section 3e). USDA has acknowledged approximately 4,400 notifications for field tests to date; another 260 have been denied,
Since the program began, approximately 120 permit applications have been withdrawn.