APHIS’s regulatory process has never led to the release of a transgenic plant that clearly caused environmental damage. However, without systematic monitoring, the lack of evidence of damage is not necessarily lack of damage. Furthermore, based on the questions raised in Chapter 4 regarding the need for a stronger scientific basis of APHIS analysis, the committee recommends that the APHIS decision-making process could be made significantly more transparent, thorough, accurate, and scientifically robust by enhanced scientific peer review, active solicitation of public input, and development of determination documents with more explicit presentation of data, methods, analyses, and interpretations.

As discussed in Chapter 2, there are two roles for risk assessment— technical decision support and creation of legitimacy in the regulatory process. The analysis here is divided into two main sections that relate to these two roles. First, the committee analyzes how APHIS has involved the public in the development of its risk assessment process and its specific rulings. Then, the technical approaches taken by APHIS to support its decisions are analyzed.


The issue of public involvement in APHIS’s decision making is complex and must be accorded a somewhat summary, even ancillary, role in the present analysis. A thorough analysis would require a book of its own! This issue is an important one because public involvement in the regulatory decision-making process is desired on at least three counts (NRC 1996):

  • Public involvement in government rule making is required by basic principles of democracy. Government authority ultimately rests on the consent of the governed, and it is desirable for public agencies to find appropriate ways to ensure that decisions are consistent with this principle.

  • Opportunities for public involvement can broaden the basis of information on which regulatory decisions are made, improving the quality of decision making.

  • Research on environmental risk indicates that public confidence in environmental policy making is particularly sensitive to the opportunity for concerned citizens to be involved in the decision-making process.

Currently, APHIS policies for public involvement conform to a fairly narrow interpretation of those required by the Federal Administrative Procedures Act. It is useful to summarize involvement at two distinct levels:

  • First, who is involved or has input into decision making in the notification, permit, and petition processes?

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