Protein ecological safety evaluations

The needs of plant protection will compel continued innovation in the nature of transgenic plants developed using pesticidal proteins. Experience to date with plant-expressed insecticidal proteins provides guidance as to the fundamental framework for the ecological safety assessments for future products. This experience shows that assessments should rely on a core set of short-term, high-dose laboratory studies to broadly establish nontarget effects. Findings of these studies may warrant refined laboratory studies or monitoring as determined on a case-by-case basis for a given protein. A tiered strategy of testing and assessment allows for this case-by-case consideration and arrives at the appropriate stopping point for the assessment. Ecological entities of concern are the logical focus of the safety assessment. These entities are determined through a problem formulation that considers those nontarget species most likely to be sensitive to a particular protein and for which there is a reasonable likelihood of exposure as determined on the basis of biology and distribution. Therefore, exposure analysis to determine probable risk under environmentally relevant exposure scenarios is a critical facet of the ecological safety assessment.

This methodology has proven to be robust in considerations of insecticidal protein ecological safety through an appropriate consideration of risk within an ecological framework. This framework considers the nature of the plant-expressed pesticide and its deployment along with the characteristics of nontarget organisms of concern.


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