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Record information and status
Record ID
Date of creation
2012-02-28 13:48 UTC (mwach@ilsi.org)
Date of last update
2012-05-25 18:50 UTC (manoela.miranda@cbd.int)
Date of publication
2012-06-01 19:12 UTC (dina.abdelhakim@cbd.int)

General Information
Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing
Keri Carstens, Jennifer Anderson, Pamela Bachman, Adinda De Schrijver, Galen Dively, Brian Federici, Mick Hamer, Marco Gielkens, Peter Jensen, William Lamp, Stefan Rauschen, Geoff Ridley, Jorg Romeis, Annabel Waggoner
Author’s contact information
Keri Carstens, Ph.D.
Regulatory Science, Pioneer Hi-Bred, DuPont
Agricultural Biotechnology, 2450 SE Oak Tree Ct.,
Ankeny, IA 50021, USA
e-mail: keri.carstens@pioneer.com
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
  • English
Publication date
Summary, abstract or table of contents
Environmental risk assessments (ERA) support regulatory decisions for the commercial cultivation of genetically modified (GM) crops. The ERA for terrestrial agroecosystems is well-developed, whereas guidance for ERA of GM crops in aquatic ecosystems is not as well-defined. The purpose of this document is to demonstrate how comprehensive problem formulation can be used to develop a conceptual model and to identify potential exposure pathways, using Bacillus thuringiensis (Bt) maize as a case study. Within problem formulation, the insecticidal trait, the crop, the receiving environment, and protection goals were characterized, and a conceptual model was developed to identify routes through which aquatic organisms may be exposed to insecticidal proteins in maize tissue. Following a tiered approach for exposure assessment, worst-case exposures were estimated using standardized models, and factors mitigating exposure were described. Based on exposure estimates, shredders were identified as the functional group most likely to be exposed to insecticidal proteins. However, even using worst-case assumptions, the exposure of shredders to Bt maize was low and studies supporting the current risk assessments were deemed adequate. Determining if early tier toxicity studies are necessary to inform the risk assessment for a specific GM crop should be done on a case by case basis, and should be guided by thorough problem formulation and exposure assessment. The processes used to develop the Bt maize case study are intended to serve as a model for performing risk assessments on future traits and crops.
Thematic areas
  • Biosafety policy and regulation
    • National/Domestic regulatory frameworks or guidelines
    • National policies
    • National administrative frameworks
    • National decision making system
  • Scientific and technical issues
    • Risk assessment
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”
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
Keywords and any other relevant information
Environmental risk assessment, aquatic ecosystem, non-target organism, genetically modified crops
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