Task Force on Stacked Events
Goal
The IFBiC Task Force on Stacked Events provides better understanding for when safety assessment is needed for biotechnology derived products in which two or more approved events are combined by conventional breeding (“stacked events”), and it documents best practices for conducting those safety assessments.
Background
Agricultural biotechnology products that are a combination of two or more approved events through conventional breeding are rapidly being brought to market1. Referred to as “combined traits/events” or “stacked events,” these products allow growers to maximize benefits of individual traits in a single offering. As additional traits are developed, the stacking of events will provide more options to growers, producers, and ultimately consumers.
Although stacked event products are entering global markets with increasing frequency, existing international approaches and data requirements for assessing their safety are varied and are often non-prescriptive (European Food Safety Authority Guidance for stacked events2). Many countries have yet to decide how they will evaluate such products, and an overall lack of harmonization indicates that several questions - if and how the safety of these products can best be assessed - remain outstanding.
The Task Force works to identify and respond to these unanswered questions with the goal to provide a scientific foundation and best practice for a safety assessment on stacked event products. The Task force will evaluate the scientific criteria indicating when a safety assessment is necessary, if any unique risks exist for stacked event products, and, if risks exist, how they may be assessed.
Work Plan and Progress
An expert panel has been assembled from academia and government in the areas of agricultural breeding, plant biochemistry, and biotechnology toxicology. The Task Force will also conduct a broader, international survey of critical issues related to stacked events to ensure a range of perspectives is considered. Two manuscripts are currently in development. The first report addresses the background of stacked events, interactions, and assessment recommendations. The second report addresses genomic stability in stacked events. It is expected both manuscripts will be submitted to peer-reviewed journals in 2010.
Impact: Improved Harmonization of Safety Guidance
Discussing and publishing the scientific underpinnings for conducting a safety assessment for stacked events will facilitate international harmonization of safety guidance in agricultural biotechnology.
2008 Task Force
Expert Panelists
Claire Halpin, University of Dundee
L. Curt Hannah, University of Florida
John Kough, US Environmental Protection Agency
Wayne Parrott, University of Georgia
Lynne Underhill, Health Canada
Members
BASF
Bayer CropScience
Dow AgroScience
Monsanto Company
Pioneer, A DuPont Company
Syngenta Biotechnology
Leadership
Linda Lahman, Monsanto (Co-Chair)
Natalie Weber, DuPont (Co-Chair)
1. James, C. 2007. Global Status of Commercialized Biotech/GM Crops: 2007. ISAAA Brief No. 37. ISAAA: Ithaca, NY
2. EFSA. 2007. Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants containing stacked transformation events The EFSA Journal. 512, 1-5