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Information Resource
Record information and status
Record ID
103134
Status
Published
Date of creation
2012-02-28 14:19 UTC (mwach@ilsi.org)
Date of last update
2012-05-25 18:50 UTC (manoela.miranda@cbd.int)
Date of publication
2012-06-01 19:13 UTC (dina.abdelhakim@cbd.int)

General Information
Title
Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants
Author
Jörg Romeis, Richard L. Hellmich, Marco P. Candolfi, Keri Carstens, Adinda De Schrijver, Angharad M. R. Gatehouse, Rod A. Herman, Joseph E. Huesing, Morven A. McLean, Alan Raybould, Anthony M. Shelton, Annabel Waggoner
Author’s contact information
J. Romeis
Agroscope Reckenholz-Ta¨nikon Research Station ART,
Reckenholzstr. 191, 8046 Zurich, Switzerland
e-mail: joerg.romeis@art.admin.ch
Organization(s) involved in the publication of this resource
Center for Environmental Risk Assessment (CERA)
1156 15th Street, NW
Second Floor
Washington, DC
United States of America, 20005-1743
Phone:+1 202 659-3306
Fax:+1 202 659-3617
Email:info@cera-gmc.org
Url:http://www.cera-gmc.org
Language(s)
  • English
Publication date
2010-10-13
Subject
Summary, abstract or table of contents
This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the GE plant has adverse effects on NTAs 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. Clear guidance on how such data are produced in laboratory studies assists the product developers 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 GE plants. Data from NTA 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 GE 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.
Thematic areas
  • Capacity building
Background material to the “Guidance on risk assessment of living modified organisms”
Is this document is recommend as background material for the “Guidance on Risk Assessment of Living Modified Organisms”
Yes
Section(s) of the “Guidance on Risk Assessment of Living Modified Organisms” this background material is relevant
Additional Information
Type of resource
  • Article (journal / magazine / newspaper)
Publisher and its location
Springer
Format
PDF
Keywords and any other relevant information
Environmental risk assessment, non-target effects, study design, tiered risk assessment, transgenic crops
Access to the resource