tion removes a transgenic plant from any further APHIS oversight. Because of the major differences between the notification and the petition for deregulation processes, each of these processes is considered individually after making a few general comments about the overall APHIS regulatory process. Comments also are provided on the third, now relatively rare, permitting process. That commentary is placed between notification and petition because the permitting process shares certain features with both. It is noted that the permitting process may become more common as it is the only route to commercialization of products from plants intentionally grown to produce pharmaceutical compounds.

General Comments and Concerns

Geopolitical Scale

The scope of APHIS oversight is limited to whether and how transgenic plants are moved and released in the United States. Although APHIS determinations sometimes include consideration of environmental impacts of deregulated genetically modified organisms outside the confines of the United States (see the case studies in Chapter 4), the agency is under no obligation to do so. Indeed, relevant scientific data may be unavailable for many countries that are centers of diversity for wild relatives of a transgenic crop. Yet these locations might be the very places where environmental impacts might occur due to transgene flow into those populations. Also, once a transgenic plant is deregulated, descendants of that plant may find themselves intentionally or unintentionally transported far beyond the borders of the United States, to radically different environments. A transgenic crop variety developed to fit into U.S. systems of agriculture may cause changes in the agricultural systems of other countries that would cause environmental degradation.

One can imagine an argument being made by certain stakeholders, that if the U.S. government found a plant to be safe, that judgment should be good enough for a country without the resources to conduct its own environmental analysis. That would be wrong. Just because APHIS finds a transgenic plant to have no significant impact in the United States is not a guarantee that it will not have an impact elsewhere. To its credit, APHIS has held biosafety meetings in a number of developing countries to inform policymakers of the potential environmental effects of transgenic plants.

Finding 5.3: APHIS’s environmental assessments should be interpreted as being confined to the evaluation of effects occurring in the United States.

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