NOTE: Last week a new report by Christoph Then and Christof Potthof was published, looking at how the risks of GM plants are analysed within the European Union.

'Risk Reloaded' has been described as "a hugely important report - very well-informed and thoroughly researched and referenced". Here we provide a simple summary of the information it contains on food safety testing arguments re the European Food Safety Authority (EFSA).

The GM lobby has long claimed that, unlike in the U.S., GM food safety risk assessments in the EU are overly rigorous. This report shows this claim to be completely untrue.
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Risk Reloaded
Risk analysis of genetically engineered plants within the European Union
http://www.testbiotech.de/sites/default/files/risk-reloaded_engl_sc_0_1.pdf

A report by Testbiotech e.V.  
Institute for Independent Impact Assessment in
Biotechnology
Authors: Christoph Then, Christof Potthof

October 2009

Summary points compiled by GMWatch

GM food safety testing

*European Food Safety Authority's (EFSA) concept of risk assessment of genetically modified (GM) plants is essentially based upon guidelines that were developed by the OECD (Organisation for Economic Co-operation and Development) as early as 1993 on the assumption that the risks posed by GM plants are the same as those posed by conventional plants.

*But the differences between conventional breeding and genetic engineering of plants are becoming clearer in the light of current genome research. Experience gained from conventional breeding cannot be applied to GM plants.

*Changes in the activity of plant genes in the genetic engineering process are not an expression of natural gene regulation but an indication of disruption.

*The outdated risk assessment methods for GM plants mean that their safety, predictability and controllability are not examined properly in the approvals procedure.

*GM plants are tested much more superficially than irradiated food, pesticides, chemicals and medicines. To prove the safety of radiated food, for example, feeding trials were conducted on mice, rats, dogs, monkeys and even humans. Feeding trials were performed over several years to investigate growth, carcinogenicity and effects on reproduction. GM plants have undergone no such investigations.

*Overall the risk assessment process for GM plants as defined by the EFSA does not even meet the requirements of the EU for comprehensive testing. It replaces actual risk testing by a system of assumptions.

*More and more cases are being documented showing that independent risk research is being hampered. In many cases it is not even possible to access necessary testing materials. Even the publication of findings is being obstructed.

*Society, politicians, and approval boards should no longer close their eyes to the fact that GM technology uses methods that are largely outdated and riskier than was originally thought. It is not the fear of new products that make a critical appraisal of GM technology necessary, but rather the fact that its scientific principles have been called more and more into question by new findings.

*More than ten years after the first commercial cultivation of GM plants, there is no generally agreed perception about the risks posed by those plants or about how to conduct proper risk assessment.

*The concept of 'substantial equivalence' (the assumption that a GM plant is substantially equivalent to its non-GM counterpart) was introduced by the OECD in 1993 and has come under harsh criticism from scientists. However, it is still seen as the starting point for the EFSA's risk assessment, thereby influencing its outcome.

*Even in cases when significant differences between transgenic plants and their counterparts are observed, they are mostly dismissed by the EFSA as being not of "biological significance" without attempts to verify or further investigate these differences to detect unintended effects.

*The EFSA does not think that feeding trials with GM plants (or derived food and feed) are necessary.

*GM plants of complex makeup cannot be assessed by analysing some of their isolated components, as is habitually done by industry in its own testing of its GM plants. Testing of whole GM plants is especially necessary on the new generation of GM crops, which have several 'stacked' GM traits. But feeding trials using whole transgenic plants are not required by EFSA.

*Scientists point out that testing should be extended to include whole-plant/whole-food testing in both toxicity and allergenicity studies in order to more reliably detect unintended and detrimental effects of genetic modification.
    
*These arguments are not followed by the EFSA. EFSA only suggests more detailed investigations in connection with products such as Golden Rice (where market authorization has not yet been applied for). According to the EFSA the metabolism of these plants can be regarded as being changed on several levels, so feeding trials with whole plants should be performed in order to avoid negative health effects. In this argument, EFSA contradicts the position of the Golden Rice team. But EFSA at the same time assumes that transgenic plants where approval for commercialisation is currently being applied for should be seen as harbouring only minor risks. EFSA does not consider feeding trials to be necessary even in the case of stacked events.
    
*EFSA states, incorrectly, that one introduced gene produces one gene product, with no other knock-on effects on the plant: "The current generation of GM plants cultivated for commercial purposes has been modified through the introduction of one or a few genes coding for herbicide tolerance, insect resistance or a combination of these traits. In these plants the genetic insert leads to the production of a gene product, which does not interfere with the overall metabolism of the plant cell, and does not alter the composition of the GM plant except for the introduced trait." The truth is that genes interact with each other in complex ways and their function is defined by the environment.

*Risks to human health of products such as radiated food, pesticides and pharmaceuticals have to be investigated to prove their safety without anything being presumed. But in the case of GM plants the risks first have to be proven before detailed investigations are made. The approach chosen by the EFSA turns around the burden of proof: GM plants are assumed to be safe until the opposite is proven.

*Just how much the science of GM has moved on from the outdated assumptions made by EFSA is clear from the patent applications of companies such as Monsanto. Here's Monsanto's patent application WO2004053055, which claims unintended effects(!) in GM plants: "Nonetheless, the frequency of success of enhancing the transgenic plant is low due to a number of factors including the low predictability of the effects of a specific gene on the plant's growth, development and environmental response, the low frequency of maize transformation, the lack of highly predictable control of the gene once introduced into the genome, and other undesirable effects of the transformation event and tissue culture process."