Blacksburg, Virginia, USA
May 6, 2010
Source: http://www.isb.vt.edu/news/2010/May10.pdf
RISK ASSESSMENT
A Mathematical Model of Exposure of Non-target Lepidoptera to Bt-Maize Pollen Expressing Cry1Ab
Joe N. Perry
In July 2007, the European Food Safety Authority (EFSA) was requested by the EU to give an opinion regarding the renewal of the authorization of maize MON810. However, the paucity of direct field data to quantify the potential lethal and sublethal effects of MON810 pollen on European Lepidoptera clearly required a new approach, if the risk was to be quantified. Mathematical modeling provides a tool to solve such problems, by which exposure analysis may be used to quantify potential risks. The approach taken by Perry et al. may afford the possibility of avoiding costly intensive field experiments, which provide notoriously variable data, and instead using mortality-dose relationships from laboratory studies to provide parameters to populate large-scale exposure models.
Molecular Profiling Techniques Detect Unintended Effects in Genetically Engineered Maize
Eugenia Barros
The controversy regarding GE plants and their potential impact on human health and the environment has necessitated the development of additional methods of risk assessment. Risk assessment focuses on adverse unintended effects that could potentially result from random transgene integration. Unintended effects can also occur in conventional breeding from mutagenesis or hybridization and backcrossing. Other factors totally unrelated to genetic engineering can contribute to alterations, including plant genetic characteristics, agronomic factors, and environmental influences. These factors need to be considered during "GE versus non-GE" evaluations. The best way to detect unintended effects is through non-targeted analysis by using profiling technologies.
REGULATORY NEWS
Three Gene Patent Cases Target Questions about Gene Function
Phillip Jones
If a person infringes a valid patent claim to a DNA molecule, then that person is liable for patent infringement. Right? Well, not necessarily.
Monsanto Company owns the rights in European patent EP0546090, which issued on June 19, 1996, and includes claims to DNA molecules that encode 5-enolpyruvylshikimate-3-phosphate synthase (EPSP) enzymes. European Union farmers are not allowed to grow Roundup ReadyR soya. Farmers in Argentina, however, cultivate Roundup ReadyR soya on a vast scale. As it happens, Monsanto does not have an Argentinean patent on EPSP DNA.
A challenge about the function of patented DNA molecules arose in another context. Again, the patent holder lost. Eli Lilly v. Human Genome Sciences began when Lilly disputed the validity of HGS' European patent No. EP0939804, which describes a newly-discovered protein called neutrokine-alpha. In July 2008, Justice Kitchin of the Chancery Division's Patent Court (UK) held that the patent is invalid. HGS appealed. The High Court of Justice published an affirmation of the ruling in February 2010.
In 2009, plaintiffs including the American Civil Liberties Union filed a lawsuit in a New York district court against Myriad Genetics and others. The plaintiffs alleged invalidity of Myriad's patent claims to molecules with nucleotide sequences of the BRCA1 and BRCA2 genes on the grounds that the patenting of human genes violated the US Constitution and US patent law. US District Judge Robert W. Sweet issued his decision in March 2010. The outcome was unexpected.
ANNOUNCEMENT
EPA Requests Comments on New Bt Soybean Registration
Federal Register: April 14, 2010
EPA has received an application from the Monsanto Company to register the plant-incorporated protectant Bacillus thuringiensis Cry1Ac protein and the genetic material (Vector PV-GMIR9) necessary for its production in MON 87701 soybean. EPA is providing an opportunity to comment on this application.
WEB LINK NEWS
Center for Environmental Risk Assessment (CERA)
http://cera-gmc.org/
The Center for Environmental Risk Assessment (CERA) is dedicated to developing and applying sound science to the environmental risk assessment of agricultural biotechnologies so their contributions to the sustainable production of food, fuel and fiber may be safely realized. As part of the non-profit ILSI Research Foundation, CERA serves as a scientific resource for governments, academic and private sector organisations. Our research projects and outreach activities include international representation from all three of these communities. The Center's research projects are currently focused on genetically modified (GM) plants. This scope will be broadened over time to include transgenic arthropods and animals.
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