Corn Insects and Crop Genetics Research Site Logo
ARS Home About Us Helptop nav spacerContact Us En Espanoltop nav spacer
Printable VersionPrintable Version     E-mail this pageE-mail this page
Agricultural Research Service United States Department of Agriculture
Search
  Advanced Search
 
Programs and Projects
Subjects of Investigation
MaizeGDB
SoyBase
 

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.

   

 
Project Team
Hellmich, Richard
Abel, Craig
Sappington, Thomas
Lauter, Nicholas
Coates, Brad
 
Publications
   Publications
 
Related National Programs
  Agricultural System Competitiveness and Sustainability (216)
  Crop Protection & Quarantine (304)
 
Related Projects
   GENOMIC RESOURCES TO ACCELERATE WESTERN CORN ROOTWORM RESEARCH
   EVALUATING NON-BT REFUGE NEEDS FOR THE CORN BELT: EFFECTS OF EUROPEAN CORN BORER RESISTANCE ALLELES AND MULTIPLE-TOXIN BT HYBRIDS
   RISK OF WESTERN CORN ROOTWORM ADAPTATION TO TRANSGENIC CORN
   NEW TECHNOLOGIES FOR THE DISSECTION OF COMPLEX PHENOTYPIC TRAITS IN LEPIDOPTERA
   EVALUATING NON-TARGET EFFECTS OF ROOTWORM MAIZE (CRY34/35AB1) ON CARABID BEETLES
   EVALUATE EUROPEAN CORN BORER INJURY AND PRODUCTION FROM OPTIMUM ACREMAX 2
   GENERATION OF SIRRL GENETIC MARKERS FOR EUROPEAN CORN BORER, WESTERN BEAN CUTWORM, AND A TORTRICID PEST OF PRAIRIE CORD GRASS
   ASSESSING THE RISK OF EUROPEAN CORN BORER ADAPTATION TO TRANSGENIC MAIZE
   DEVELOPMENT OF GENOMIC TOOLS FOR THE INVESTIGATION OF EUROPEAN CORN BORER POPULATION DYNAMICS
   THE TARGETED SEQUENCING OF BACTERIAL ARTIFICIAL CHROMOSOME (BAC) CLONES FROM WESTERN CORN ROOTWORM
   BLENDED REFUGE VERSUS BLOCK REFUGE
 
 
Last Modified: 05/23/2013
ARS Home | USDA.gov | Site Map | Policies and Links 
FOIA | Accessibility Statement | Privacy Policy | Nondiscrimination Statement | Information Quality | USA.gov | White House