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COMMENT OF THE REPORT: " An appraisal of the working in practice of directive 90/220/EEC on the deliberate release of genetically modified organisms " Issued 2 January 1998 By Dr. René von Schomberg, contracted by STOA (Scientific and Technological Options Assessment) of the European Parliament (The original document can be found at URL: http://www.europarl.eu.int/dg4/stoa/en. It is available, with some editings by us in Adobe format at URL: http://www.psrast.org/eudir90.pdf. 38 pages, 82 Kb, requires Adobe Acrobat Reader that can be downoaded here. The editings in bold and italics were made to help you find what I think are important passages. No text has been deleted or changed.) For you who want to read our conclusion and recommendation first, click here: Conclusion __________________________________________________________________________________________ The commission of Dr. Schomberg was to investivate possibilities for a conciliation of the disparate opinions about risks of GMO release among the different member countries of the European Union (EU) with reference to the EU-directive 90/220/EEC. 1. The EU directive 90/220/EEC It represents "the minimal consensus of the member states that the introduction of genetically modified organisms should be regulated". It says a.o. that : 1. Living organisms may "reproduce, cross national frontiers and cause `irreversible' effects". 2. It is required that prior to each GMO release, the applicant must submit an environmental risk assessment, e.g., as regards the potential for `ecological interactions'; this requirement places the burden of evidence upon the applicant. 3. "Member states may undertake all appropriate measures `to avoid adverse effects on human health and the environment' from GMO releases (Article 4)". __________________________________________________________________________________________ Comment Such guidelines may seem reassuring. But experience indicates that this is misleading: The EU directive does not define "evidence for safety" nor "environmental harm". The concept of "adverse effects on human health and environment is left open for interpretation by the member states". The text says: " For market approval of a GMO product, the application must be filed in the member state where marketing is expected to begin. If it recommends approval, then an EU-wide procedure allows for objections, to be resolved by voting if necessary." And most importantly: "Final approval would then apply to all member states". The directive means in practice that the Biotech industry will rapidly find out what country has the most favourable position versus GMO release and have their products released there first. As it is left open to the member states to interpret what is a hazard, this leaves the field open to considerable arbitrariness. And so far, if a GMO has been approved in one state, it has been difficult for other member states to prevent EU-wide approval because of the strongly favourable attitude of the EU-commission. The voting procedure mentioned above is not sufficient to ensure the interests of more vigilant countries, not even of a large majority of member states. This became apparent when the EU-commission decided to approve the Basta resistant corn although 15 out of 16 member states had voted against approval. So the commission can use its power to overrule the opinion of practically the whole of EU. The EU-commission demands strong "scientific evidence" of harm to accept non-approval. The EU-directive that the burden of proof of safety has to be on the producer seems thereby to be neglected in practice. Absence of scientific evidence of harm is not a scientifically acceptable basis for responsible decisions in safety matters. Absence of evidence is not evidence of absence of harm. Therefore the demand for strong evidence of harm is untenable. It should be replaced by a firm demand for strong evidence of harmlessness if the EU-commission wants to remain credible as a body that takes true responsibility for the environment. __________________________________________________________________________________________ 2. The report of Dr Schomberg Usually risk assessments are based on scientific knowledge of known hazards. In the case of GE organisms, the author finds that there are important deficiencies in the scientific knowledge about environmental hazards. The report recognizes the practical difficulties of making reliable field studies without jeopardizing the environment. And there are considerable difficulties in designing such studies so that they will yield strong evidence of safety. Therefore, little is known about the ecological safety of GMO:releases. - The author writes: " Our current knowledge does not provide us with the means to predict the ecological long-term effects of releasing organisms into the environment. So it is beyond the competence of the scientific system to answer such a question, although precisely this assumed competence is normally the basis for an authoritative appeal". __________________________________________________________________________________________ Comment This is the most important conclusion of this report. It means that present "scientific" safety evaluations of ecological hazards from GMO:s are essentially the result of unsubstantiated guesses. The serious lack of scientific knowledge about the risks of GMO release leaves the field open to considerable arbitrariness. Any release is therefore an experimentation with unknown and unpredictable consequences. This is especially serious as the release of a GMO is irreversible. If a release turns out to cause serious harm, it may cause permanent damage for all future. __________________________________________________________________________________________ Schomberg The biotechnologists argue that the consequences of releases can be foreseen on the basis of the familiarity principle. That is, familiarity with the inserted gene + familiarity with the crop = safety. Schomberg notes that "the familiarity principle is scientifically incorrect: but is applied by biotechnologists because of it's demonstrated practicality. This pracitality simply overrides the need for new ecological data in indivividual cases." __________________________________________________________________________________________ Comment The familiarity principle is scientifically untenable. It is another attempt of the "biotechnologists" to confuse the issue before regulators and politicians. It is an undeniable fact that the insertion of a foreign gene, however well known it may be, produces unpredictable effects that makes it impossible to predict the properties of a crop on the basis of the unfamiliarity principle. So in the absence of evidence of safety the "biotechnologists", are trying to establish an acceptance of an unscientific principle just because of its "practicality". __________________________________________________________________________________________ Schomberg As the environmental safety of the products can not be established on the basis of present scientific knowledge, it has been suggested that the evaluation should be based on an evaluation of the safety of the technology. Thereby the issue would be transformed from Risk Assessment (RA) to Technology Assessment (TA). If the technology yields products that are not essentially different from breeding it is suggested that there is no need for assessment of the environmental consequences. __________________________________________________________________________________________ Comment - This is the same kind of judicial trick as that behind substantial equivalence. In the absence of scientific knowledge about the safety of GMO:s one tries to downplay the issue to one of comparison of technologies. This may make a reassuring impression on non-specialists and is the kind of tactic repeatedly used to convince politicians and regulators that no true safety assessment is required. It has no scientific basis. - Every instance of genetic engineering is unique and may have unique environmental effects. Therefore the "comparison of technologies" tactic is as invalid as the principle of substantial equivalence. __________________________________________________________________________________________ Schomberg "Technology Assessment procedures can yield a reasonable provisional consensus in individual cases, but do not remove the difference among scientific disciplines. It is therefore incorrect to suggest that these provisional conclusions on individual cases allow us to say something substantial on the general level of the "risks" of gene-technology as such." "The impossibility to foresee the long-term and the cumulative effects of releases, nor the ability to define exactly how they look like, forces us to continue with a precautionous case-for-case approach and invest in the monitoring of releases" (this is an exact transcript so the language errors are not typographical errors). __________________________________________________________________________________________ Comment Here Schomberg is somewhat obscure and apparently inconsistent. What is "reasonable consensus individual cases"? How can there be any "reasonable" consensus about the hazards of release in the recognized absence of scientific knowledge about long term effects? As the releases are irreversible, how can (Schomberg:) " the impossibility to foresee the long-term and the cumulative effects of releases, and the ability to define exactly how they look like " justify any releases at all? __________________________________________________________________________________________ As there is no scientific basis for risk assessment, Schomberg found that it is not possible to establish any common basis for reliable assessment of the safety of release of GMO:s. Therefore he suggests "us to continue with a precautionous case-for-case approach and invest in the monitoring of releases". This means in practice exposing the environment to large scale experiments with irreversible gene releases without any knowledge of possible hazards. The absence of a knowledge about risks leaves the field open to considerable arbitrariness. In practice, the countries least concerned about potential hazards will set the EU-wide norms for approval because the union rules obliges all countries to follow the decision of the approving country. Even if there is a formal possibility of voting against it, the EU-commission can overrule a negative vote, and has done so, in one case even when 15 out of 16 countries voted against. Once again, as in the case of the toothless labelling directive,
EU is creating a non-committing paperwork expressing good intentions
to protect the public and the environment, but in practice does not ensure
sufficient means to keep out potentially harmful products. Jaan Suurkula M.D. The recommendation of PSRAST to the European Union Considering that:
- Therefore, instead of creating regulations allowing large scale
experimentation with unforeseeable ecological consequences, we recommend
EU to decide upon a moratorium on all releases of GMO:s including a withdrawal
of all present release approvals, see also our Declaration.
Physicians and Scientists for Responsible
Published: February 1998 POST SCRIPTRadical change of EU policy in 1999On 24 June 99 the EU ministers of the Enviroment decided to implement a factual moratorium on any new approvals for the commercial release of GE organisms. The acting EU president Juergen Trittin (Germany) annouced that "on the basis of the precautionary principle the EU will not authorize any new GMOs in Europe until the introduction of strict environmental standards." In the autumn of 1999, the EU radically changed the resesarch policy on food biotechnology. Great cuts in the research programme of the union to develop new genetically modified crops and plants was made. The move reflects increasing political and public concern over genetic engineering of plants. The new program of EU has the emphasis more on research into health, environment and sustainable agriculture. Related text"Is there sufficient knowledge about environmental effects to justify release of GE organisms""Genetically Engineered Food - Safety Problems" News Introductory articles Health hazards Environmental hazards Global issues Safety issues Alternatives to GE FAQ About us What You can do Membership E-mail How to sponsor us |