Submitted to: Nature Biotechnology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 12/7/2007
Publication Date: 2/1/2008
Citation: Romeis, J., Bartsch, D., Bigler, F., Candolfi, M., Gielkens, M.C., Hartley, S.E., Hellmich II, R.L., Huesing, J.E., Jepson, P.C., Layton, R., Quemada, H., Raybould, A., Rose, R., Schiemann, J., Sears, M., Shelton, A., Sweet, J., Vaituzis, Z., Wolt, J. 2008. Assessment of Risk of Insect-resistant Transgenic Crops to Nontarget Arthropods. Nature Biotechnology. 26(2):203-208. Interpretive Summary: An initiative has been launched by the International Organization of Biological Control (IOBC) to develop a generic and scientifically rigorous approach to evaluate potential risks of genetically modified (GM) crops on non-target arthropods (insects and spiders). This paper focuses on insect resistant crops. The group includes regulatory toxicologists and industry and public sector scientists who have been working with GM crops over the past 10 years. This initiative is adapting the widely-established tiered approach to risk assessment that has been used internationally for decades, within regulatory toxicology. This paper outlines the basic principles of this approach and reports ways in which the tiered risk assessment framework has been updated and refined. The approach described here captures an important stage in the development of the IOBC program, the first complete outline of the risk assessment framework. It is intended to provide guidance to countries that are currently developing risk assessment guidelines and to help harmonize regulatory requirements in different regions of the world.
Technical Abstract: An international initiative is developing a scientifically rigorous approach to evaluate potential risks to non-target arthropods (NTA’s) posed by insect-resistant, genetically modified (IRGM) crops. It adapts the tiered approach to risk assessment that is accepted internationally within regulatory toxicology. We outline the basic principles of this approach and report ways in which it has been refined by scientists from public, industrial, and regulatory sectors who have extensive experience with IRGM crops. The approach is distinguished by its focus on the formulation and testing of clearly stated risk hypotheses, making maximum use of available data and using formal decision guidelines to progress between testing stages (or tiers). It is intended to provide guidance to regulatory agencies that are currently developing their own NTA risk assessment guidelines and to help harmonize regulatory requirements between different regions of the world.