"EFSA is not fit for purpose "
OPEN LETTER
Catherine Geslain-Laneelle Executive Director, EFSA Parma Italy
10th December
2007
Dear Mrs Geslain-Laneelle,
EFSA Refusal to address issues of scientific malpractice
Thank you for your letter dated 5th December. We fear that it is totally unacceptable, and we have never before seen such hypocrisy and complacency from an organization that purports to uphold high scientific standards and to protect the public.
I note that you have not seen fit to express any regret for the fact that we have been waiting since 18th May for our points to be answered in a sensible fashion, and I am intrigued by your comment that you had thought our concerns to have been fully addressed. You knew full well that our concerns had simply been ignored; and we fear that after receipt of this letter we are no further forward. Our conclusion has to be that EFSA is simply intent upon evading the issues we have raised, and that it does not wish to confront the very serious matters of scientific ethics that we have brought to your attention. We would like to refer to the following:
1. On confidentiality / "commercial in confidence" issues
Article 2001/18/EC is not very helpful, since the wording is so vague (1). The onus is on the Commission and the "competent authorities" to decide what to do about confidentiality. This document was brought in before EFSA came into existence. But it should surely be assumed that EFSA should have a role in the implementation of this Directive in any case, along with the Commission and the member states. Regulation 1829/2003 is much more specific, and designates a role for EFSA (2). It is called "The Authority" throughout the text. The areas in which the applicants for GM consents have got away with all sorts of skulduggery in the past are these: (c) physico-chemical and biological characteristics of the GMO, food or feed; (d) effects of the GMO, food or feed on human and animal health and on the environment; (e) effects of the GMO, food or feed on the characteristics of animal products and its nutritional properties; These effectively cover the research work submitted in the dossiers in support of applications -- and in the wording of the Regulation they "shall not be considered confidential". In the case of MON863 the member state, the Commission and EFSA connived in supporting Monsanto and in the pretence that parts of the research dossier should be protected as "commercially confidential" -- and it took a court case in Germany to obtain the release of the full dossier (3). When it was released, it was -- not surprisingly -- discovered that it was shot through with scientific malpractice (4).
We accept that Regulation 1049/2001 relates to EU, Commission and EFSA documents rather than documents submitted by applicants for GM consents. Nonetheless, with respect to application dossiers and supporting materials, it is extraordinary for you to pretend that EFSA has no role to play in the decisions as to what is confidential and what is not. EFSA is in constant contact with the Commission and the members states / competent authorities, and it is absurd to suggest that the Commission makes decisions on the matter of confidentiality without any reference to EFSA. Has EFSA ever complained about segments of dossiers being classified as confidential when they should be open to peer review? And has EFSA ever made representations to the Commission seeking full public access to these dossiers except for genuinely sensitive material? The rules specify that the only material which may be classified as secret is data on the manufacturing process / genetic characterization of the GM variety; and that all material relating to health and safety issues must be released into the public domain. Many would argue that it is in the public interest for NOTHING to be classifies as confidential, since seed developers are still protected by their patents. We therefore reject the claim that EFSA "is not involved in this process". If, under Article 30 (Clause 6) EFSA is expected to share responsibility for protecting genuinely sensitive information, it must also have a shared duty to ensure the release of "information which must be made public if circumstances so require in order to protect human health, animal health or the environment." EFSA has simply chosen not to exert its influence or to use its powers, leading to the conclusion that the protection of the biotechnology corporations is deemed more important by EFSA than the protection of public health.
2. On Reference Materials
You refer us to the JRC / IRMM in Belgium but fail to address the central issue raised in our correspondence -- namely the systematic blocking of bona fide research by GM seed / patent holders (5). In our last letter we invited you to address this by examining the behaviour of large corporations like Monsanto and Bayer, who routinely seek to "enhance" their own research results in the furtherance of their own commercial ambitions, and who systematically block those who wish to repeat or replicate research using patented reference materials. We are still waiting for you to tell us where the reference materials for MON863, MON810 and NK603 maize are located, and to tell us what procedure needs to be followed by bona fide researchers who wish to access them for laboratory and animal feeding studies? As far as we can gather, IRMM supplies reference materials in vials containing 1 g of certified powder. That may be useful for researchers who want to work with amplicons. But I am sure you will agree that material in this form is of no use whatsoever to Professor Darvas and his colleagues in Hungary, or to any other research teams wishing to conduct either environmental research or animal feeding studies with the precise GM varieties for which you have precipitately given consent.
You must be aware that not only do the biotechnology corporations refuse to supply certified GM seed or meal for independent researchers, but that they enforce their patent rights with enthusiasm and even brutality. These rights are defined in the technology use agreements (TUAs) which prohibit the purchaser of GM seed from saving it for replanting or from undertaking research, or from passing it on to a third party for replanting, research or breeding (6). This means that it is well-nigh impossible for genuinely independent research teams to source the test materials which they need for their studies. EFSA cannot claim ignorance on this matter, since we have frequently sought to bring it to your attention. At the very least, EFSA has to be guilty of failing to seek genuinely impartial verification and/or rejection of the findings reported in scientific dossiers -- and according to the regulations it DOES have the powers to ask for such studies to be done. This is a very serious and potentially criminal situation, since EFSA advice or opinions based upon deliberately skewed or partial scientific information, and upon the suppression or rejection of "inconvenient" information, can be construed as misrepresentation or deception by EFSA itself.
3. On EFSA policy re materials considered prior to the formulation of "Opinions"
You say that it is your responsibility to consider ALL data relevant to a particular application, regardless of source. Of course we agree with that as a matter of principle. You then say "Deliberately excluding data from the evaluation........would not be in line with internationally determined scientific standards nor enable a full risk assessment to be realized." But what if the provider of that data (the applicant) is systematically involved in statistical manipulation, selective citation, questionable experimental design and other unethical practices, as in the case of MON863? And what if the same applicant is systematically blocking research by others who wish to replicate or extend experiments in order to check on the reliability of the "results" submitted in supporting dossiers? This brings us into very murky ethical waters, and it is quite extraordinary, to our mind, that you and your colleagues in EFSA will not go on the record as condemning these appalling practices, in spite of frequent requests from GM Free Cymru and others.
We appreciate that EFSA does not make legislation, and that if we want the rules changed we should talk to the Commission and the Parliament. But EFSA is the official advisory body with a direct line to the Commission; and it is profoundly depressing that you continue to pretend that there is absolutely no problem with the situation that currently prevails. If you cannot see corrupt science when it is staring you in the face, we are drawn to the conclusion, not for the first time, that EFSA is directly involved in misrepresentation and deception (7), and is therefore not fit for purpose.
Here is a compromise statement for you to consider as a matter of urgency, since you were obviously not interested in our previous suggestion:
"In the interests of public safety, EFSA will not consider any dossier or any other research material submitted in support of an application for a GMO approval to be complete unless (a) it is accompanied by a signed declaration to the effect that the scientific research (including full data sets) will be open to public scrutiny and peer review; and (b) it is accompanied by a signed declaration that repeat, additional or extended experiments by bona fide independent researchers and laboratories will be facilitated through the provision of GM reference materials as appropriate." (The words "to be complete" have been added since our last letter.)
You can make this statement in the form of advice to applicants, and you can request the approval of the Commission if you feel that you need that. You would still have the freedom to examine incomplete and defective dossiers, and to refer back to applicants with formal requests for declarations which they might have omitted to include.
Until you take action to stamp out scientific malpractice associated with the GM approvals process, we fear that EFSA will remain -- in the view of many NGOs and consumer groups -- a body which turns a blind eye to scientific corruption and which exists simply to "facilitate" the commercial ambitions of the GM corporations. We now take the view that EFSA advice in the GM field is dressed us in scientific terms, but that it is actually worthless, being predicated upon the commercial ambitions of biotechnology companies and driven by political expediency.
Yours sincerely
Dr Brian John GM Free Cymru
NOTES
(1) Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organismsand repealing Council Directive 90/220/EEC http://www.biosafety.be/GB/Dir.Eur.GB/Del.Rel./2001_18/2001_18_25.html
(2) Regulation (EC) No 1829/2003 of the European Parliament and of the Council
of 22 September 2003 on genetically modified food and feed
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:
32003R1829:EN:HTML
(3) http://www.gmfreecymru.org/news/Press_Notice24May2005.htm
(4) http://www.gmfreecymru.org/news/Press_Notice14March2007.htm
http://www.i-sis.org.uk/GMmaizeMON863toxic.php
(5) http://www.gmfreecymru.org/pivotal_papers/manipulation.htm
PERVERTED SCIENCE
-- THE MANIPULATION OF GM RESEARCH How "inconvenient" GM research
is stifled, starved, marginalized and patronized
(6) Typical Canadian Monsanto GM corn and soybean TUA reproduced here (available on request)
(7) The legal understanding of 'deceive' in Britain is 'to induce a person to believe that thing is true which is false, or a thing false which is true, contrary to that which the person practising the deceit knows or believes to be the case (see Welham VDPP(1961)AC 103). The subtlety of the definition is that it acknowledges a deceit is not only caused by lying or concealing --- a person is simply 'induced' to believe something false, and that has a wide meaning. It can cover a wide spectrum of tricks including concealing information and presenting ambiguous information. In contract law, 'misrepresentation' entails a 'false statement which misrepresents a material fact..which is made with the intention that the person to whom it is addressed shall act on it (see UK Misrepresentation Act 1967). An offence shall be committed deliberately, through neglect or innocently, if the miscreant has 'no reasonable grounds for believing that the statement to be true'. A further clarification by a British Law Lord, Lord Denning, holds that 'any behaviour, by words or conduct, is sufficient to be misrepresentation if it is such as to mislead the other party. If it conveys a false impression, that is enough' (Curtis v Chemical Cleaning and Dyeing Co.Ltd(1951) 1 KB 805).
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EXTRACTS
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Directive 2001/18/EC
Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
http://www.biosafety.be/GB/Dir.Eur.GB/Del.Rel./2001_18/2001_18_25.html
Article 25
Confidentiality 1. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.
2. The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive position and which should therefore be treated as confidential. Verifiable justification must be given in such cases.
3. The competent authority shall, after consultation with the notifier, decide which information will be kept confidential and shall inform the notifier of its decisions.
4. In no case may the following information when submitted according to Articles 6, 7, 8, 13, 17, 20 or 23 be kept confidential:
- general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses;
- methods and plans for monitoring of the GMO or GMOs and for emergency response;
- environmental risk assessment.
5. If, for whatever reasons, the notifier withdraws the notification, the competent authorities and the Commission must respect the confidentiality of the information supplied.
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Regulation 1829/2003 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX: 32003R1829:EN:HTML
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
Article 29
Public access
1. The application for authorisation, supplementary information from the applicant, opinions from the competent authorities designated in accordance with Article 4 of Directive 2001/18/EC, monitoring reports and information from the authorisation holder, excluding confidential information, shall be made accessible to the public.
2. The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(29) when handling applications for access to documents held by the Authority.
3. Member States shall handle applications for access to documents received under this regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.
Article 30
Confidentiality
1. The applicant may indicate which information submitted under this Regulation it wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.
2. Without prejudice to paragraph 3, the Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.
3. Information relating to the following shall not be considered confidential:
(a) name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indication of the substrate and the micro-organism;
(b) general description of the GMO and the name and address of the authorisation-holder;
(c) physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);
(d) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environment;
(e) effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;
(f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);
(g) information on waste treatment and emergency response.
4. Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.
5. The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.
6. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.
7. If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information as to the confidentiality of which the Commission and the applicant disagree.