by Angela Ryan and Mae-Wan Ho
The new European Directive 2001/18 /EC on deliberate release of GMOs is broadly welcomed by environmental groups and condemned by GM proponents, especially the US, claiming it smacks of trade restrictions and is unworkable.
The most significant element in the new Directive, and one that, if strictly implemented, is likely to disqualify most if not all GMOs for environmental release, is the requirement for molecular data documenting that the GMO is genetically stable.
ISIS and other scientists have been warning for years that GMOs are unstable, and insisting that molecular data documenting genetic stability of transgenic lines must be provided before any environmental release is allowed. Unless the transgenic line is stable, one might as well forget about studying its long term environmental or health impacts.
The first line of defence against the risks of GMOs is the technical and scientific detail required to characterise the genetic modification(s), including "genetic and phenotypic stability" and "techniques for detecting transfer of GM material to other organisms".
This should be good news for all concerned. It has the potential to simplify approval procedures for biotech companies and to restore transparency and public confidence, for the data can easily be checked by regulatory authorities.
A Belgian research group recently showed how it could be done using Monsanto 's Roundup Ready soya. Monsanto's technical dossier, submitted for approval, had claimed that Roundup Ready soya had a single insert with the intended order of genes. The analysis revealed, however, that both the GM construct and the host genome have been scrambled (rearranged), and hundreds of basepairs of unknown DNA has got in as well [1], which should have caused RR soya to be withdrawn there and then. The procedures are relatively simple and straightforward, and could be applied to any GMO, plant or animal.
A potential loophole in the Directive exists under 'differentiated procedures' for non-commercial releases. The differentiated procedures of Article 7, in turn, enables competent authorities to make use of 'simplified procedures' of the old directive 90/220. Simplified procedures will apply if "sufficient experience has been obtained on releases of certain GMOs", allowing authorities to "establish the minimum amount of technical information necessary for evaluating any foreseeable risks from the release".
The minimal criteria for 'differentiated procedures' in the current Directive include molecular characterisation (Annex V, see box 3). It stipulates that, "information shall be available to demonstrate that any inserted genetic material is well characterised, including the construction of any vector systems or sequences of genetic material used with the carrier DNA". But this could be excluded if the previous 'simplified procedures' were to apply.
GMOs in farm scale trials come under differentiated procedures, and so there is the possibility for the simplified procedures to be applied. However, all GMOs will eventually have to satisfy the requirements of the new Directive before going onto the market. So, what is the point of wasting money investing in GMOs that will only be rejected later on because they fail in the most basic criterion of genetic stability? There is no case for retaining the simplified procedures from the old Directive.
Perhaps the proponents of GM can't face the awful truth that all GMOs may be genetically unstable [2]. This is now confirmed by studies commissioned by the EC itself [3]. A three-year risk assessment at University Blasise Pascal in France & The Max-Planck-Institut fur Zuchtingsforschung in Germany, explored mechanisms that contribute to genetic instability in GMOs. It concludes:
"Biotechnology relies to a large extent on our ability to introduce foreign genes into cells. A major problem with present day technology is the non-predictability of the integration of such transgenes. DNA introduced into plant cells mostly integrates at random, i.e. at non-predetermined positions of the genome. The biological process ultimately responsible for random integration is known as illegitimate recombination. DNA integrated at random frequently contains multiply copies and often copies are scrambled. Multiple copies also often induce gene silencing and hence instability in the expression of the introduced genes. In addition, the DNA integrates at loci of unknown stability and capacity for expression of randomly integrated copies may induce unpredictable and undesirable mutations in the host genome.we still lack the knowledge for precision engineering of plants' genes." [4].
The commission also funded research to evaluate horizontal gene transfer from GMOs to the microflora, and in animal gut [5]. (This is another area ISIS has covered extensively, and follows directly from the structural instability of GMOs.) The study notes that the risks of "horizontal gene transfer cannot be excluded", stating, "Free DNA persists in some materials for weeks, and furthermore, some bacteria develop natural/chemical competence to take up DNA from the environment. In addition, in the gastrointestinal tract of man and husbandry animals, DNA may remain stable for some time, particularly in the colon."
Genetic stability is perhaps the single most important criterion in biosafety risk assessment in terms of concreteness and methodological simplicity. It is astonishing that decades and billions of dollars of investments should have been wasted, when this criterion alone could have exposed the futility of the whole approach.
It is high time for all rational GM proponents to abandon ship and cut their losses, instead of continuing to imperil the rest of the world.
See "Scrambled genome of RR soya" by Mae-Wan Ho and Joe cummins, ISIS News 9/10, July 2001 ISSN: 1474-1547 (print) ISSN: 1474-1814 (online) http://www.i-sis.org/isisnews/i-sisnews9-13.shtml
See "GM crops face potential genetic meltdown" (http://www.i-sis.org/meltdown.shtml) by Joe Cummins, also "GM rice unstable" (http://www.i-sis.org/isisnews/i-sisnews9-14.shtml) by Mae-Wan Ho, ISIS News 9/10, July 2001 ISSN: 1474-1547 (print) ISSN: 1474-1814 (online); plus many more on ISIS website.
We thank Mark Griffiths for this information. See
http://www.btinternet.com/~nlpwessex
http://europa.eu.int/comm/research/quality-of-life/gmo/01-plants/01-14-project.html
http://europa.eu.int/comm/research/quality-of-life/gmo/04-food/04-07-project.html
The Traceability Report, http://www.traceabilityreport.com
Source: The Institute of Science in Society
http://www.i-sis.org
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London NW1 OXR
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