Perspective abstract

Nature Biotechnology 26, 203 - 208 (2008)
Published online: 7 February 2008 | doi:10.1038/nbt1381

Assessment of risk of insect-resistant transgenic crops to nontarget arthropods

Jörg Romeis1, Detlef Bartsch2, Franz Bigler1, Marco P Candolfi3,19, Marco M C Gielkens4, Susan E Hartley5, Richard L Hellmich6, Joseph E Huesing7, Paul C Jepson8, Raymond Layton9, Hector Quemada10, Alan Raybould11, Robyn I Rose12, Joachim Schiemann13, Mark K Sears14, Anthony M Shelton15, Jeremy Sweet16, Zigfridas Vaituzis17 & Jeffrey D Wolt18

An international initiative is developing a scientifically rigorous approach to evaluate the potential risks to nontarget arthropods (NTAs) posed by insect-resistant, genetically modified (IRGM) crops. It adapts the tiered approach to risk assessment that is used internationally within regulatory toxicology and environmental sciences. The approach focuses 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 for IRGM crops and to help harmonize regulatory requirements between different countries and different regions of the world.

  1. Agroscope Reckenholz-Tänikon Research Station ART, Reckenholzstr. 191, 8046 Zurich, Switzerland.
  2. Federal Office of Consumer Protection and Food Safety (BVL), Mauerstrasse 39-42, 10117 Berlin, Germany.
  3. RCC Laboratories India Private Ltd., Genome Valley, Turkapally, Shameerpet, Ranga Reddy District, Hyderabad 500078, India.
  4. National Institute for Public Health and the Environment, Expertise Centre for Substances, PO Box 1, 3720 BA Bilthoven, The Netherlands.
  5. Department of Biology and Environmental Science, University of Sussex, Falmer, Brighton BN1 9QG, UK.
  6. USDA–ARS, Corn Insects and Crop Genetics Research Unit and Department of Entomology, Iowa State University, 110 Genetics Laboratory c/o Insectary, Ames, Iowa 50011, USA.
  7. Regulatory Sciences, Monsanto Company, 800 N. Lindbergh Blvd., St. Louis, Missouri 63167, USA.
  8. Integrated Plant Protection Center and Department of Environmental and Molecular Toxicology, Oregon State University, Cordley Hall, 2040, Corvallis, Oregon 97331-2907, USA.
  9. Regulatory Sciences, DuPont Crop Genetics, 7250 NW 62nd Ave., PO Box 552, Johnston, Iowa 50131-0052, USA.
  10. Program for Biosafety Systems, Department of Biology, Calvin College, 1726 Knollcrest Circle, S.E., Grand Rapids, Michigan 49546-4403, USA.
  11. Syngenta, Jealott's Hill International Research Centre, Bracknell, Berkshire RG42 6EY, UK.
  12. USDA–APHIS Biotechnology Regulatory Services, 4700 River Rd., Unit 146, Riverdale, Maryland 20737, USA.
  13. Julius Kuehn Institute, Federal Research Centre for Cultivated Plants (JKI), Institute for Biosafety of Genetically Modified Plants, Messeweg 11/12, 38104 Braunschweig, Germany.
  14. Department of Environmental Biology, University of Guelph, Guelph, Ontario N1G 2W1, Canada.
  15. Department of Entomology, Cornell University/NYSAES, 630 W. North Street, Geneva, New York 14456, USA.
  16. Environmental Consultant, The Green, Willingham, Cambridge CB4 5JA, UK.
  17. Biopesticides and Pollution Prevention Division, USEPA 7511P, 1200 Pennsylvania Ave. NW, Washington, DC 20460, USA.
  18. Biosafety Institute for Genetically Modified Agricultural Products and Department of Agronomy, Iowa State University, 164 Seed Science Center, Ames, Iowa 50011, USA.
  19. Present address: BASF SE, APD/EE, LI 425, 67117 Limburgerhof, Germany.

Correspondence to: Jörg Romeis1 e-mail:


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