Regulatory perspective on insecticidal protein ecological safety

The ecological effects of current-generation Bt crops have been extensively evaluated from a regulatory perspective in order to ensure that this technology is safely deployed.27-30 In addition, there is now an extensive published literature evaluating effects of plant-expressed insecticidal proteins on nontarget insects, at scales from laboratory to semi-field and field environments.

As insecticidal agents, protein toxins are evaluated from an ecological safety perspective as part of the registration process of the U.S. Environmental Protection

Agency (EPA). In addition, the U.S. Department of Agriculture (USDA) considers ecological safety under the mandates of the National Environmental Policy Act when genetically engineered crops are evaluated as part of USDA's deregulation process. Broadly similar regulatory standards for ecological safety are utilized in all nations where Bt crops have been commercially introduced, as well as in import markets.31-33 Although standards are similar in design and intent, global harmonization is needed for the regulatory processes that establish ecological safety for genetically engineered crops. The benefits of harmonization include timeliness of decisions, effective use of regulatory resources, streamlined processes of global trade, and decreased ambiguity in addressing consumer questions. Key aspects of the regulatory assessment of an insecticidal protein are: (1) the necessity for case-by-case considerations of product risks; (2) use of a recursive (tiered) approach to assessment allowing risk recognition, mitigation, and management to be continually reevaluated in light of new knowledge; and (3) use of protein characterization and history of use as an element of the case-by-case analysis of risk.

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