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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
ciated with regulated transgenic plants. There are three possible paths to commercialization in which external input could be considered:
An applicant can petition for nonregulated status, which means the transgenic plant can be released without regulatory oversight. (See Chapter 3 for details of the petitioning process.) At present this avenue is the most common pathway to commercialization. As of the end of 2000, APHIS had received a total of 73 petitions for deregulation. Of these, 52 petitions had been approved, 19 had been withdrawn, two were incomplete, and none had been denied. APHIS works with applicants to clarify the standards for approval. As a consequence, petitions are improved, sometimes substantially, prior to an APHIS decision. The lack of denials could be related to this clarification process, which among other functions serves to inform applicants of the likelihood of approval of petitions.
An applicant can commercialize the products of a regulated article (but not the live plant itself) under the permitting system. (See Chapter 3 for details of the permitting process.) The permitting system is also used to accumulate data needed for commercialization through the first path. However, based on the relatively small number of field tests conducted under permit, this approach is rarely used. In the year 2000, only 36 field tests were performed under permit.
A final path for developing commercial products from a regulated article is through use of the notification system. One drawback to this approach is that APHIS may, at any time, require permits for applicants who are growing a regulated article under notification. (See Chapter 3 for details of the notification process.) Notification is also currently the primary route for field testing to gather information needed for commercialization through the first path. In the year 2000, almost 900 field tests were conducted under notification, and several products have been commercialized.
APHIS publishes its intent to deregulate or permit (if it conducts an environmental assessment for the latter) in the Federal Register. Comment periods are summarized in Chapter 3. In the case of notifications, the agency does not publish each notification separately or in a published list. Instead, it maintains an updated list of all submitted notifications (Federal Register 1992). APHIS periodically publishes a Federal Register notice announcing the list’s availability (but apparently has not done so for several years). On request, the agency provides the list directly to interested parties. APHIS has made arrangements with the National Biological Impact Assessment Program to make the notification list available online (see “Field Test Releases in the U.S.,” Information Systems for Biotechnology database: www.nbiap.vt.edu). Note that there is essentially no opportunity for either general public comment or external scientific review on notification decisions prior to a decision being made.