Technical Analysis of the Permitting Process

As noted earlier, the permitting process is currently a relatively rare APHIS decision-making process for transgenic plants, with only a few dozen such decisions per year. Prior to introduction of the notification process, the permitting process was the only regulatory mechanism for conducting field trials, so the total number of permit decisions associated with field tests numbers over a thousand.

Similar to the petition process, permit applications contain more than the simple list required for notification—that is, they provide some scientific information and analysis. The information provided by the applicant is primarily for the purpose of assuring appropriate confinement and disposal of the transgenic plants.

Most permit applications, like all notification applications, are not listed in the Federal Register during the process of APHIS assessment unless they include an Environmental Assessment as required under the National Environmental Protection Act. From 1996 to the present, APHIS appears to have conducted environmental assessments for about 6% of the permit applications processed. If APHIS does not issue an environmental assessment reporting on its environmental risk assessment, there is no potential for feedback from stakeholders except the applicant. And even when an assessment is issued, feedback from interested and affected parties could be frustrated by information that is limited because of CBI.

Plants grown under permit share certain characteristics with plants grown under notification. There are no restrictions to the acreage under which they may be grown, and they may be grown to produce nonliving commercial products. As noted elsewhere in this report, it is anticipated that transgenic plants intentionally grown to produce commercial pharmaceutical products will be grown under permit. Thus, problems associated with the scale of the plantation discussed for notification may also apply to plants grown under permit. However, while APHIS personnel visit only a subset of notification field sites, all permit sites are visited.

The committee’s findings and recommendations under the section on notifications generally apply to the permit process as well.

Technical Analysis of the Petition Process

If APHIS approves a petition for deregulated status, deregulation is absolute. APHIS generally indicates that it cannot “conditionally,” “temporarily,” or “partially” deregulate. For example, APHIS cannot deregulate an article but require monitoring of it. Similarly, APHIS deregulates a regulated article and all of its descendants. As noted in Chapter 3, trans-



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