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United States Department of Agriculture

Agricultural Research Service

Research Project: ECOLOGICALLY-BASED MANAGEMENT OF INSECT PESTS OF CORN, WITH EMPHASIS ON CORN BORERS, ROOTWORMS, AND CUTWORMS

Location: Corn Insects and Crop Genetics Research

Title: Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants

Authors
item Romeis, Jorg -
item HELLMICH, RICHARD
item Candolfi, Marco -
item Carstens, Keri -
item DE Schrijver, Adinda -
item Gatehouse, Angharad -
item Herman, Rod -
item Huesing, Joseph -
item Mclean, Morven -
item Raybould, Alan -
item Shelton, Anthony -
item Waggoner, Annabel -

Submitted to: Transgenic Research
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: September 13, 2010
Publication Date: February 1, 2011
Citation: Romeis, J., Hellmich II, R.L., Candolfi, M., Carstens, K., De Schrijver, A., Gatehouse, A.M., Herman, R.A., Huesing, J.E., McLean, M.A., Raybould, A., Shelton, A., Waggoner, A. 2011. Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants. Transgenic Research. 20(1):1-22.

Interpretive Summary: Genetically-engineered plants and food and feed products derived from them are strictly regulated by governments internationally. Through the implementation of regulatory systems, designated authorities mandate a pre-market environmental risk assessment and a food/feed safety assessment of genetically-engineered plants case-by-case. These evaluations are a prerequisite to the regulatory decision to approve or not approve genetically-engineered crops for cultivation and for human food and/or livestock feed consumption. This paper provides recommendations on experimental design for laboratory studies used to evaluate potential adverse impacts of arthropod-resistant genetically-engineered plants on non-target arthropods. Clear guidance on how such data are produced in laboratory studies assists the product developer and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These recommendations contribute to the robustness of, and confidence in, environmental risk assessments for genetically-engineered plants. Confidence in the results of laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing. This information is useful to all scientists and regulators interested in evaluating the potential impact of genetically-engineered plants on non-target organisms.

Technical Abstract: This paper provides recommendations on experimental design for early-tier laboratory studies used in the risk assessment process to evaluate potential adverse impacts of arthropod-resistant genetically-engineered plants on non-target arthropods. While we rely heavily on the currently used proteins from Bacillus thuringiensis in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the genetically-engineered plant has adverse effects on non-target arthropods when they are exposed to the arthropod-active protein. Typically, the risk assessment follows a tiered approach that starts with laboratory studies under worst-case exposure conditions; such studies have a high ability to detect adverse effects on non-target species, if present. Clear guidance on how such data are produced in laboratory studies assists the product developer and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These properties contribute to the robustness of, and confidence in, environmental risk assessments for genetically-engineered plants. Data from non-target arthropods studies, collected during the analysis phase of an environmental risk assessment, are critical to the outcome of the assessment and ultimately the decision taken by regulatory authorities on the release of a genetically-engineered plant. Confidence in the results of early-tier laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing.

Last Modified: 7/28/2014
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