tee does not understand why APHIS has repeatedly allowed field testing of this transgenic plant under the notification system. The fact that the substance coded for by the transgene has the potential to be an allergen was of special interest. Examination of APHIS guidelines revealed that plants with allergenic properties can be grown under notification. The committee questions the wisdom of allowing such plants to be grown under the streamlined notification system. Regulation of novel compounds under notification raises the more general question of how APHIS determines that a compound is not toxic to non-target species in the field, given the limited information that must be provided by applicants. The committee’s comments on the APHIS procedures are not meant to imply that there is any risk in this specific case where the applicant seems to have taken extra steps to ensure human and environmental safety.

Finding 5.7: It appears that a transgenic plant with toxic properties to non-targets was grown to create a commercial product under the notification process.

APHIS personnel must process the notification applications very rapidly (see Chapter 3). The total number of APHIS personnel available to process notifications, permits, and petitions appears to be insufficient. Currently there are about 10 permanent APHIS biotechnology evaluations staff. From the time the committee began its study in July 2000 until July 2001, APHIS always had staff vacancies, and staff turnover rates appear to be high. This situation results in a heavy per-person workload. The heavy workload coupled with no public feedback may detrimentally affect the rigor of the determinations.

The number of APHIS personnel who conduct field visits to sites under notification and permit is also small. This includes the permanent APHIS Biotechnology, Biologics, and Environmental Protection (BBEP) staff plus APHIS field personnel who are not all trained to understand the implications of the evaluations they are making. (To the credit of APHIS, it is clear that these field personnel are, on average, better trained today than they were five years ago. Turnover in field personnel makes maintaining adequate training levels difficult.) To maintain compliance with performance standards, sufficient numbers of appropriately trained personnel must be allocated to visit field sites. Only a subset of notification sites receives an inspection visit. In field seasons such as 2001, when APHIS field inspectors have an emergency priority (of inspecting for foot and mouth disease), few may be available to visit notification sites.

Recommendation 5.4: Because of the large number of field tests conducted, resources for compliance monitoring are necessary to maintain a suitable number of well-trained APHIS field inspectors.



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