ribbon committees, standing committees, external contracts, and public jury approaches. Some European countries use standing committees of public-sector scientists or mixtures of public- and private-sector scientists to provide wider deliberations on critical issues. Others contract with public-sector scientists to provide detailed critiques of materials entering into the decision process. The 2001 revision of European Union’s Directive 90/220 specifies that applicants perform the risk assessment (unlike in the United States, where a government agency performs the risk assessment). This allows the European regulatory community to solicit evaluations of these assessments using external scientists in ways that would be unwieldy for APHIS.

None of these efforts at involving the public can be undertaken without considerable cost in terms of both money to actually carry out the exercises and staff time and potentially needless delays in the regulatory process. Arguably, the effect of efforts undertaken outside the United States to involve greater segments of the public has been to considerably broaden the basis of decision making beyond that of the scientific disciplines deemed relevant to the interpretation and measurement of environmental risk by APHIS staff. Whether this other approach to decision making reflects greater sensitivity to alternative perspectives, including consumer and citizen desires, or an intrusion of inappropriate nonscientific viewpoints regarding what should be a science-based regulatory process is the subject of continuing debate.

Finding 5.2: There is a need to actively involve more groups of interested or affected parties in the risk analysis process while maintaining a scientific basis for decisions.


There is no question that the APHIS regulatory processes that have evolved to handle transgenic plants have resulted in a system that allows for thousands of field tests and dozens of deregulations of transgenic plants while at the same time allowing for scientific scrutiny of the regulated articles. Nonetheless, there are opportunities for improvement of this system.

This section starts with general comments relevant to all APHIS decision-making processes—notification, permit, and petition. It then focuses on each process separately. The most important APHIS decisions regarding transgenic plants are those made during the notification and deregulation processes, because of the hundreds of field releases of transgenic plants under notification that occur every year and the fact that deregula-

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