Finding 5.1: The notification process involves no public input.

Beyond publication in the Federal Register, the legislative authority under which APHIS regulates transgenic plants does not stipulate formal mechanisms for involving external participants. However, the agency has developed guidelines for petitioning for nonregulated status and for submitting notifications. These guidelines provide for deliberative interactions between APHIS and the parties seeking to commercialize the product (see Chapter 3 for details). APHIS sometimes uses informal processes to contact outside experts to solicit information (see Chapter 4, squash case study), but it also has the authority to convene such groups formally to provide external advice.

External Input into the Establishment of Policy

Table 5.2 summarizes previous involvement of potential participant groups in APHIS policy-making processes, including developing risk analysis procedures and procedures for commercializing a transgenic plant or its products. Three of the primary processes are listed.

As discussed in Chapter 3, APHIS once used a subcommittee of the U.S. Department of Agriculture’s Agricultural Biotechnology Research Advisory Committee (USDA-ABRAC) to provide advice for initiating the notification process. The agency has also held a number of national and regional meetings to discuss its policies with stakeholders.

The rationale for APHIS risk management activities is determined largely by statutory authority. Because the U.S. Coordinated Framework for the Regulation of Biotechnology was developed under statutes put in place before the advent of transgenics, no public debate or congressional testimony specifically relating to the environmental risks or public confidence issues associated with transgenic plants occurred in connection with the creation of APHIS statutory authority.

Effectiveness of Efforts to Solicit External Input

The processes summarized in Tables 5.1 and 5.2 are somewhat effective in ensuring democratic decision making and improving the quality of APHIS’s decisions, as noted earlier. Certainly, publication in the Federal Register in compliance with the Federal Administrative Procedures Act is intended to provide at least some degree of democratic legitimization of the general rule-making process. Although theorists of democracy and governmental procedure continue to debate the adequacy of this approach to public participation, debate transcends APHIS policies and the appropriate focus of this report. In addition, APHIS has been somewhat successful at using public input to improve the quality of its decisions, as



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