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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
tions. Comments on a number of permits have elicited detailed technical responses from APHIS staff and on several occasions have resulted in requests for additional data or additional studies on the likely risks posed by issuance of a permit (see deregulation case study of virus-resistant squash in Chapter 4). The effectiveness of the public comment period for this purpose depends on an informal network of people and organizations that monitor the Federal Register and generate or recruit comments from people having relevant expertise.
The committee notes that external input through the Federal Register publications, whether from scientists or the public at large, has dwindled over the years. In information provided by APHIS, the committee found that they received a total of 378 comments for the first 10 petitions they considered (from 92-196-01p to 94-319-01p); the greatest number was for the second petition involving virus-resistant squash (92-204-01p, see Chapter 4). In contrast, for the 10 most recently approved petitions (from 97-287-01p to 99-173-01p), APHIS received a total of 11 comments for 3 of them, and no comments for the others. It is possible that the decline in comments is due to improved APHIS decision making, or a decrease in interest on the part of external scientists and the public. In the case of decreasing numbers of negative comments, another possibility is that frustration with the process may have resulted in declining public involvement in this specific process. Indeed, information provided by members of the public interest community confirmed that their perceived lack of responsiveness of APHIS to the comments they provided during deliberations over the transgenic squash petition (92-204-01p) marked a “watershed” for them in which they felt their efforts proved a “waste of time” and that in the future their efforts were better spent on activities other than writing comments to APHIS. No matter what the actual cause, APHIS may be losing potentially valuable public input. The lack of input from outside scientists in precedent-setting decisions is especially problematic. In contrast, the Environmental Protection Agency (EPA) often convenes formal scientific advisory panels to provide information that will help improve the technical rigor of its decisions.
The Federal Register comment process has several weaknesses for the purpose of eliciting public involvement. First, Federal Register notices are often quite technical and not written in a manner that is accessible to the lay public. Second, when public comments have been issued regarding questions about confidence in the regulatory process for biotechnology, APHIS’s responses have largely been perfunctory. For example, early in the history of permits a number of comments were submitted expressing the view that the U.S. regulatory approach was incomplete or had gaps. The APHIS response was either to simply note disagreement with these opinions or to reply that they were not relevant to the particular decision