New report slams EFSA complacency and bias
Comment by Brian John

This is a hugely important report by Christoph Then and Christof Potthof. Very well-informed and thoroughly researched and referenced.    It gives EFSA a real going-over, for its assumptions of GM safety, its inadequate terms of reference, its defective science, its acceptance of poor or fraudulent submissions and experimental reports from GM applicants, and its strong bias towards the GM industry    – as a result of all of which it places the people of Europe at risk. This should be required reading for all MEPs and the members of supposedly independent advisory and regulatory bodies like ACRE and ACNFP – and for NGOs and consumer groups it gives a lucid and somewhat chilling insight into EFSA's corrupt working methods.

Finally, in response to those who claim that genetic modification is a high-tech and sophisticated business conducted by scientists who actually know what they are doing, one can do worse than quote this, from Monsanto: “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.”

Please read the Report.
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Risk Reloaded РRisk analysis of genetically engineered plants within the European UnionӬ
http://www.testbiotech.de/sites/default/files/risk-reloaded_engl_sc_0_1.pdf

A report by Testbiotech e.V.ӬInstitute for Independent Impact Assessment in BiotechnologyӬ www.testbiotech.org

ӬOctober 2009Ӭ

Christoph Then, Christof PotthofӬ
Editing: Andrea Reiche

EXTRACTS

Summary

This is a report on the risk assessment procedure for genetically engineered plants in the EU. It reveals substantial flaws and loopholes in the procedure and practice of the institutions concerned.

Many of the flaws have their origin in the European Food Safety Authority’s (EFSA) own main concept of risk assessment. This is essentially based upon guidelines that were developed by the OECD as early as 1993 on the assumption that the risks posed by genetically engineered plants are basically the same as those posed by conventional plants. This approach has admittedly been revised several times since 1993 but has in essence remained unchanged.

The report shows that the current guidelines are inadequate for sound risk assessment. New findings in genome research have in recent years transformed ideas of gene regulation and gene function. It has become evident that invasive intervention in genetic makeup and the transfer of isolated genes cannot be equated with natural mechanisms of heredity and gene regulation. The basic difference between conventional cultivation and genetic engineering of plants is becoming more and more distinct in the light of current genome research.

Experience gained from cultivating conventional plants cannot or only to a very limited extent – be applied to genetically engineered plants.

Even in conventional cultivation there are many changes in the genome but these do not break through the natural system of gene regulation.

In contrast a new metabolism is forced upon genetically engineered plants. In fact the regularly observed changes in the activity of plant genes in this process are not an expression of natural gene regulation but an indication of disruption. These transgenic plants1 are technically manipulated products and as such much be assessed unconditionally for constructional flaws, quality defects and risks.

The outdated basic concept of the OECD from 1993 and the subsequent concepts developed for risk assessment of genetically engineered plants (FAO/WHO, 2000; Codex Alimentarius, 2003; EFSA, 2006) mean that the safety, predictability and controllability of genetically engineered plants are not examined in detail within the framework of approval procedure.

Irradiated food, pesticides, chemicals and medicines are all unconditionally tested for possible risks. In order to thoroughly test genetically engineered plants, however, there first of all has to be some proof that there may be a risk. Genetically engineered (GE) plants are deemed to be safe as long as no proof to the contrary has been produced. This means that GE plants are tested much more superficially than irradiated food, pesticides, chemicals and medicines.

Overall the concept as defined by the EFSA (2006, 2007a, 2007b) does not meet the requirements of the EU for comprehensive testing. It replaces actual risk testing by a system of presupposed assumptions based upon conclusions that are hardly verifiable.

In this report the authors give an overview of the reasons for recent doubts about the safety of genetically engineered plants and present different examples which show the inconsistencies and failures in EFSA’s risk assessment. One of the examples used to expose the lack of essential requirements for well-founded risk assessment is MON 810 maize which produces the Bt insecticide.

It is also extremely problematic that 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. All in all the influence of industrial interests in research and the presentation of findings have reached alarming proportions.

Against the backdrop of various political discussions on the further development of testing standards in the EU, the authors make concrete suggestions on how testing systems can be improved to generate more data on the quality and safety of genetically engineered plants. They advocate more extensive testing on the compounds and genetic stability of GE plants before they are released into the field and companies can apply for market authorisation.

The plants should be subjected to a suitable level of exposure in specific “crash tests” to test their reaction to changing and extreme environmental conditions. Before field release and in order to collect more data on potential risk they should be tested (i.e. with different microorganisms) in a contained system to detect any interaction between the plants and a simulated environment. The authors suggest that these tests be introduced in the course of introducing improved step by step, case by case tests which have clearly defined test criteria for genetically engineered plants; with concomitant stronger collaboration between the authorities of member states and EU authorities and a higher consideration of ethical and socio-economic factors. The documentation of relevant information shall become a precondition for EU authorisation procedures.

Society, politics and approval boards should no longer close their eyes to the fact that agro-gene technology uses methods that are largely outdated and whose risk potential is higher than originally thought. It is not the fear of new products that make a critical appraisal of agro-gene technology necessary, but rather the fact that its scientific principles have been called more and more into question by new findings.

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Some recommendations

(1) Risk assessment of genetically engineered plants should be conducted without preconditions such as assumptions of similarity (familiarity, substantial equivalence) between transgenic plants and plants derived from conventional breeding. The comparison between genetically engineered and conventionally bred plants is an essential tool in risk assessment, but substantial equivalence and familiarity cannot serve as a basic approach or starting point. Transgenic plants have to be seen as technically derived products with specific risks and have to be subjected to comprehensive risk assessment per se.

(2) Before the applications for market authorisation are filed, a mandatory step by step procedure with sufficiently defined criteria should be introduced. To avoid unnecessary feeding trials and field trials, testing in contained systems should be given more weight. This new step by step procedure could part of an integrated risk analysis which requires closer cooperation between EU member states, the EU Commission and EFSA and also encompasses ethical, socio-economical and risk related issues (see for example Haslberger, 2006; Gesche&Haslberger, 2006).

Possible tests which should be performed in an early step of risk analysis are stress exposures of transgenic plants under defined conditions (crash tests), profiling metabolic compounds under different stages of plant growth and environmental conditions, simulations of different ecological systems and interactions with different external factors. Before feeding and/or field trials take place, socio- economic and ethical questions should be assessed according to defined criteria. Table 3 tries to give an overview of the early stages of a new step by step procedure for risk analysis.

These investigations result in data which allow a first insight into the stability and predictability of the transgenic plants as well as the formulation of initial hypotheses on the possible effects on particular organisms and and ecological systems. Investigations like field and feeding trials cannot be fully replaced by these early step in the risk analysis. To avoid unnecessary trials which are of ethical and ecological concern, it is important to perform the testing as proposed in Table 3 in the framework of an integrated risk analysis which also takes socio-economic and ethical criteria into account as a prerequisite for further investigations. These requirements of integrated risk analysis should become a mandatory part of market authorisation procedures.

(3) To support independent risk research, unrestricted access to research material has to be provided. This access has to be guaranteed at the filing date of applications for experimental field trials at the latest. In addition companies should pay at fixed rates into a publicly organised fund which can be used as financial resources for independent research projects. The spending of these funds has to be organised in an independent and transparent manner and involve a range of different research groups.

(4) Clearly defined rules for the selection of potential staff members of the authorities and other experts involved and their code of conduct have to be developed, as do mechanisms that serve to provide absolute transparency about their contacts with industry, to foster the independence of EU authorities.

(5) A system that enables effective monitoring of potential health effects at consumer level is a prerequisite for any authorisation.
Regarding risks to the environment, case-specific monitoring is necessary in any case as soon as a risk potential can be scientifically described. This always should be the case, for example, if plants produce toxic compounds such as Bt insecticides. Further, in view of the general risks from genetically engineered plants, there are good reasons to apply case specific monitoring as a rule, even if just to confirm that no risks can be identified. The existing networks and proposed systems of Ogeneral surveillance’ are not sufficient to examine risk assessment findings after market authorisation has been given.
(6) Plants that contain stacked events have to be subjected to a comprehensive examination as complete new applications even if the different events have already passed risk assessment. If new transgenic plants are authorised, interactions with other genetically engineered plants already on the market have to be assessed.

Even if substantially improved concepts for risk assessment apply, it cannot be expected that the risks from genetically engineered plants can be controlled or excluded. This dilemma should be communicated quite openly. The technical manipulation of the plants’ genome might no longer be seen as a big technical challenge – but insight into the complexity and possible impacts has increased substantially in the last few years. It is already evident that even today it is a matter of open discussion whether there is a generally authoritative definition of what a gene is (Pearson, 2006). Perceptions and defitions will differ depending on the context.

The increasing knowledge about the complexity of genome regulation is a strong argument for promoting conventional breeding concepts such as marker assisted selection. These new concepts in conventional breeding apply recent findings in molecular biology but not invasive methods for technical manipulation of genetic information. For the future of plant breeding the usage of the whole range of existing biodiversity will be much more relevant than the methods of transferring isolated gene sequences. Besides unanswered questions about the true risk from transgenic plants, success in recent conventional breeding also provides strong arguments for a change of paradigm which has been on its way for some years already even in some of the bigger seed companies.

The shift of paradigm can be traced to patent applications by companies such as Monsanto. As is written in its patent application WO2004053055, which claims unintended effects (!) in genetically engineered 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.”

All in all it is time for a fundamental rethink of risk assessment and usage of genetically engineered plants in agriculture and food production.