I thank the Commission for this further reply, and of course I am happy to accept the Commission's assurance that it "considers the protection of health and the environment as a top priority." However, I am intrigued that the Commission did not refer to the protection of health and the environment as THE top priority in this area of GM crops and foods. Any other priorities that it has, such as the encouragement of business opportunities, or the support of GM multinationals, or the appeasement of the WTO, should in my view, as a European citizen, be far down the list.
The Commission says that "genetically modified (GM) seed, food and feed are authorised only when they are not likely to have adverse effects on human health, animal health or the environment." It repeats what it has often said before, that "the safety assessment of GMOs is carried out based on the highest standards". Speaking as a scientist and a consumer, I am afraid I cannot accept either of those statements, for reasons enumerated on my Petition. Furthermore, I venture to suggest that my scepticism is shared by many thousands, if not millions, of European citizens (1) whose views are ignored by the Commission. Many GM products have already been authorised which are likely to have (and probably already are having) negative direct and indirect environmental and health effects -- as is made clear by recent peer-reviewed research (2).
Safety assessments in the EU are fundamentally flawed, as many of us repeatedly point out. Neither EFSA nor the Commission are prepared to accept that the methods and results of genetic engineering are fundamentally different from conventional breeding and growing. GM plants are not seen as "new manipulated organisms" but as comparable to conventionally bred plants. So EFSA does not require comprehensive investigations of GM plants, although they are known to have a broad range of unintended effects (3). By ignoring unexpected non-linear effects EFSA is placing all us us -- as consumers -- in danger.
Furthermore, EFSA's standards are not mandatory even in crucial details. EFSA's own assessment procedures are not designed to meet Codex Alimentarius standards, which is a major defect in the system. Empirical investigations are mostly replaced by assumptions, many of which involve INCREASED (rather than reduced) risk to consumers. For example, GM varieties with "stacked events" need not be tested if the single gene constructs have already been assessed. Synergistic effects are assessed in a very vague fashion. The procedure as proposed by EFSA now bypasses the "stepped procedure for containment" laid out in European regulations -- starting in the laboratory, going to the greenhouse, then to small field trials and after that to larger field trials. This process requires strong evidence from each step that the plants do not bear risks for health or the environment. Although EFSA is not directly involved in the authorisation of experimental field trials, it should define the requirements that must be met at all stages of the risk assessment if company is to be permitted to apply for market authorisation. In addition, in its new proposals EFSA does not mention any criteria for a rejection of applications, and it still sees its brief as the facilitation of authorisations rather than the protection of the public. For example, commercial growing of plants that foster non-sustainable agricultural practises should be rejected. EFSA should also reject all applications concerning genetically engineered plants (for example GM canola) likely to be invasive or persistent and which therefore could not be removed from the environment after a large-scale release (4).
There are other things too which indicate the poor standard of EFSA assessments. Both EFSA and the Commission still adhere to the outmoded and scientifically useless concept of "substantial equivalence" -- in spite of the fact that research shows it to be nonsense (5). That concept should never again be used as a starting point for risk assessment. It is still not compulsory for applicants for GM consents to reveal all of their existing studies and data -- so they can cherry-pick their results and bind them into their research dossiers in a fashion that best suits their interests. This leads -- as we have seen on many occasions -- to scientific fraud which EFSA hardly ever identifies, effectively leaving that task to others who have the persistence and the expertise to apply close scrutiny to research data sets and conclusions. Applicants are often allowed to get away with studies that examine risk across a very narrow range of parameters, of their own choice; in contrast, they should be required to examine impacts at all levels of the food web and for different receiving environments. Risk assessments do not sufficiently consider cumulative, synergistic, combined and long-term effects arising from the growing and use of GM products; studies are almost always short- term, and EFSA seems to expect that long-term effects will become apparent through some rather vague protocols for post-facto monitoring. It seems to be too naive to appreciate that no GM developer is going to take monitoring at all seriously, if that might place its reputation and its share value at risk. Feeding studies are -- as has been pointed out by many observers -- currently far too short to bring out any chronic effects from the cultivation and consumption of GM products. Even 90-day feeding trials are inadequate -- there should be lifetime studies, and also studies over several generations, to either prove or disprove some of the very worrying material about reproductive effects already enumerated in the literature. Ethical and socio-economic issues should be incorporated into an integrated risk analysis procedure, and many of us would like to see something on the Norwegian model -- in which "societal benefit" has to be assessed befora any GM consent is issued. (6) And finally both EFSA and the Commission must take active steps to eliminate research blocking by the GM patent holders, which effectively kills off any attempts by independent scientists to undertake safety studies or environmental impact studies, or even to verify or disprove the findings contained within GM application dossiers. EFSA must insist that any GM material released for commercial use (and its isogenic counterparts) must be freely available for independent scientific research and must not be restricted by consensus or contract with the intellectual property holder.
The Commission suggests that EFSA has updated its Guidance Documentation so as to "to clarify which standards and protocols should be used by applicants to carry out scientific studies, provide a better structure and define clear objectives and conclusions in each part of the safety assessment." It also says that in the review of the old guidance notes, and the replacement with the new ones, there was widespread consultation and overall transparency. I am afraid I do not accept any of that, as I have already indicated in earlier submissions. I still think it was absolutely inappropriate -- and legally questionable -- for EFSA, as an advisory body, to be so closely involved in writing what is in effect its own rule book. From my wide network of contacts, I know a lot about the "consultation process" and I am fully aware of the means by which "desired outcomes" can be achieved, partly through making it impossible for citizens like me to find out what the weight and emphasis of comments received actually was, and partly through "diplomatic" measures inside and outside meetings!
I am afraid that I see no reason to vary my view that the Revised EFSA Guidance is intended to simplify application and assessment procedures, to lower scientific thresholds, to increase the number of applications receiving consents, and to facilitate a fast-track approvals system (7). I also think that the Draft Implementing Regulation sent to the WTO last February involved a number of illegal policy changes -- and I have already enumerated these to the Commission. I am horrified to hear that "the draft Commission Regulation could be soon submitted for opinion as the first step of adoption through the comitology procedure". That would be a disaster for European citizens, since it would be part of a package which would loosen up all of the mechanisms currently in place for the protection of health and the environment. I do hope that the Parliament will insist on that document being withdrawn and completely rewritten.
POINT 4 OF MY SUBMISSION DATED 23 MARCH 2010: The Commission response dated 12 July 2010 completely sidesteps the points that I was making, and I do not accept their reply as adequate. The Commission says: "applicants are obliged to provide studies, including where available independent peer-reviewed studies to demonstrate that the GMOs do not have adverse effects on human or animal health or the environment". The key here is in the words "including where available". If independent studies are not available, because the patent holder has refused to supply reference materials, or GM feed, or isolines, to independent researchers, then EFSA simply shrugs its shoulders and accepts whatever IS available. That sort of attitude will be even more prevalent if the new Guidelines are accepted than it was under the old ones -- and this sort of connivance and complacency on the part of EFSA is completely unacceptable. I am sorry, but this does make me, as a consumer and a citizen, very angry indeed.
POINT 5 OF MY SUBMISSION DATED 23 MARCH 2010: I made the point that EFSA "does not properly scrutinize the relationship between data sets and "safety conclusions" and permits, for example, the use of surrogate proteins instead of insisting on the use of actual proteins isolated from the GM product under consideration." The Commission replied: "There are circumstances where surrogate proteins have to be used for toxicological testing because the protein produced from the plant cannot be obtained in sufficient quantity". It is my understanding that those circumstances are extremely rare, and it remains my position that the safety of European citizens is going to be placed at risk is tests are not undertaken on the whole plant -- as it will be planted or consumed. EFSA has far too much room for discretion here, in assuming over and again that surrogate proteins, for example, are perfectly relevant to give indications of the safety of a GM plant entering the food chain.
POINT 8 OF MY SUBMISSION DATED 23 MARCH 2010: I complained about restricted access to scientific dossier information (including research protocols and data sets) and about the excessive use of "commercial in confidence" provisions to protect GM applicants / patent holders where they do not need protecting at all. I quote: "The Commission has not received any formal complaint regarding its decisions on confidential information". I am not sure what the Commission counts as a "formal complaint" -- but I have personally had several instances where it has been a nightmare to obtain dossier information, only to have received documentation with extensive tracts blacked out and with many pages missing. As we all know, on a number of occasions it has taken court action for dossiers and data sets to be released for independent scrutiny. This is just not good enough. Genetic constructs etc are in any case protected by patent law, and I know that many tracts which were blacked out before material was sent to me had nothing to do with commercial secrets, and were not blacked out when those same documents were sent to others!
POINT 9 OF MY SUBMISSION DATED 23 MARCH 2010: I complained about research blocking and the great obstacles faced by researchers who want to replicate or extend the research conducted by GM applicants. I argued that this allows fraudulent research to be fed into the assessment pipeline, and places citizens at risk, since that poor- quality research cannot be tested or replicated. The Commission again shows utter complacency on this issue, pretending that it can do nothing about it. It says, with respect to the Material Transfer Agreements used by Monsanto, Syngenta etc, "The Commission has not received any complaints by researchers or any other stakeholders in the EU about the legality of these agreements". That is a classic fudge, addressing a complaint that I did not make. I simply argued that the Commission's acceptance of this situation is against the public interest. The Commission also said: ".......... limitations in research may not be linked to the system of intellectual property rights, but to provisions of the agreements which have been voluntarily signed by the researchers." Oh dear oh dear. My whole point here is that many researchers who would like to conduct safety assessments and other work on GM materials do not even get the chance to sign a Material Transfer Agreement -- over and again, Monsanto and the other big companies not only refuse to allow access to their materials to scientists whom they consider to be "unfriendly", but they also threaten any grower who might have the temerity to pass GM materials on to a third party for research use (8). I am once again staggered by the Commission's apparent failure to appreciate why I -- and many other scientists -- are angered by this state of affairs.
I am reassured that many of the points made above were also made by the ENVI delegation which visited EFSA on 23 - 25 June 2010; and I note that this dissatisfaction with EFSA procedures (9) is shared by many of the national delegations participating in the ongoing discussions about the Commission's plans -- for example in the recent meeting of Agriculture Ministers.
Once again, I fear that the Commission has failed adequately to address the points I am making, and it has failed to allay my fears. I am more convinced than ever, after this protracted exchange of views, that EFSA procedures are defective, allowing potentially dangerous GM food and feed to enter the food chain, thereby placing our health at risk. I am also convinced that if the Commission gets its way with the proposed changes in the assessment procedure, that the risk of harm will be greatly enhanced. The Commission appears not to have the will to change things on behalf of the citizens of Europe. Is it because of the fear of upsetting EFSA? Or is it because of the fear of upsetting the WTO and the USA administration?
I have to conclude that the Commission does not really understand how science works. It appears to think that it can leave "the science" of GM in the capable -- or incapable -- hands of EFSA, and that once EFSA has established the safety or otherwise of a particular GM variety, then that is that. EFSA encourages that belief, since it is clearly intent upon taking effective control of the European GM safety / risk analysis / authorisation process. Like all big organizations, it wants to build its empire and make itself indispensible. As national regulatory bodies withdraw from the risk assessment process (sometimes for financial reasons), more and more power is concentrated in EFSA's hands; and the latest Commission proposals (written with more than a little help from EFSA) will accelerate this process further. EFSA perpetrates the myth of its scientific infallibility by NEVER changing its opinion on the safety of a GM product, once an initial evaluation is made, even when new information demonstrating harm comes into the public domain. That in itself is bad science.
Both EFSA and the Commission appear to be wedded to the idea that GM varieties are "substantially equivalent" to their conventional isolines, and that they are by default assumed to be just as safe. That is, and always was, a profoundly dangerous ruling hypothesis (5). Science is not like that. It is always fluid, and advances in knowledge are always made through the minute scrutiny of working hypotheses and the falsification of theories -- with every step moving the scientific community a little closer to the truth. If the process of scientific research and discourse is disrupted, as it has been (very comprehensively) through GM research blocking and the vilification of scientists who discover "uncomfortable" things about GM crops and foods, then we are all losers -- and our health is threatened. We are not talking about pharmaceuticals here -- which will be consumed by only specific groups of the population. We are talking about GM products which will be fed to ALL of the people of Europe, young and old, male and female, healthy and infirm. On that basis much greater care must be taken over GM safety and risk assessments than we have with pharmaceuticals, and having examined all of the points put to me by the Commission I am not at all convinced that they understand what I am talking about.
I do find it extraordinary that when it comes to the assessments and approvals process for GM varieties developed by GM multinationals like Monsanto and Syngenta, EFSA and the Commission are apparently inclined actually to believe the science contained in their research dossiers. That is profoundly worrying, since both companies have a long history of lies, deception, and fraudulent research (10). And while EFSA blithely accepts corporate research which cannot be trusted at face value, it applies high levels of scrutiny and scepticism to any independent research brought to its attention, if the work happens to have been done by scientists who are not employed by the GM multinationals.
I fear that the Commission has abandoned individual common sense and responsibility in favour of the supposedly "expert" authority called EFSA, and over and again Commissioner Dalli talks with pride about his "science-based decisions". He does not make science-based decisions; he makes EFSA-based decisions. And these are fundamentally flawed, since the EFSA risk assessment protocols, secret data, and impossibility of peer review and independent research replication are completely out of tune with agreed standards of real scientific practice.
On the basis of the foregoing, I repeat that I am not at all satisfied with the responses I have received from the Commission. I maintain my contention that the current (and future) modus operandi of EFSA fails to protect me as a citizen of the EU and to ensure my continuing good health. EFSA has breached its responsibility to European consumers and to Regulation 178/2002 Section 4: Article 37-40 on Independence, Transparency, Confidentiality and Communication.
Dr Brian John Trefelin Cilgwyn Newport Pembrokeshire SA42 0QN UK
1. The Avaaz Petition on GMOs has now been signed by 1,082,000 EU citizens. It is worded as follows: "To the President of the European Commission José Manuel Barroso: We call on you to put a moratorium on the introduction of GM crops into Europe and set up an independent, ethical, scientific body to research the impact of GM crops and determine regulation". When this is handed in to Mr Barroso, it will be deemed an "official request for action", and by law it must be acted upon.
2. Paganelli, A., Gnazzo, V., Acosta, H., López, S.L., Carrasco, A.E. 2010. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signalling. Chem. Res. Toxicol., August 9. http://pubs.acs.org/doi/abs/10.1021/tx1001749
http://www.gmfreecymru.org/open_letters/Open_letter10Sept2010.html "GM SOY - Sustainable? Responsible?" by Michael Antoniou, Paulo Brack, Andrés Carrasco, John Fagan, Mohamed Habib, Paulo Kageyama, Carlo Leifert, Rubens Onofre Nodari, Walter Pengue. Summary of key findings) GLS Gemeinschaftsbank eG / ARGE Gentechnik-frei (2010) A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health Joël Spiroux de Vendômois, François Roullier, Dominique Cellier and Gilles-Eric Séralini International Journal of Biological Sciences 2009; 5(7): 706-726Detection of transgenic cp4 epsps genes in the soil food web Miranda M. Hart, Jeff R. Powell, Robert H. Gulden, David J. Levy- Booth, Kari E.Dunfield, K. Peter Pauls, Clarence J. Swanton, John N. Klironomos, Jack T. Trevors Agron. Sustain. Dev. 29 (2009) 497-501 www.agronomy-journal.org
http://bit.ly/6gauyk ARTEMIS DONA and IOANNIS S. ARVANITOYANNIS, 2009 Health Risks of Genetically Modified Foods Critical Reviews in Food Science and Nutrition, 49:164-175 (2009)2
(3) Latham, J.R. Wilson, A.K., Steinbrecher, R.A. 2006. The mutational consequences of plant transformation. J. of Biomedicine and Biotechnology 2006, 1-7.
(4) Then, C. & Potthof, C., 2009, risk reloaded - risk analysis of genetically engineered plants within the European Union, Testbiotech report, www.testbiotech.org Then, C., 2010, AgroBiotechnology: Testbiotech opinion on EFSA's draft guidance on the environmental risk assessment of genetically modified plants, Testbiotech report, www.testbiotech.org
(5) http://www.gmfreecymru.org/documents/landmark.html http://www.comcom.govt.nz//MediaCentre/MediaReleases/200910/inghamswarnedovergmfreechickenclai.aspx More evidence that "substantial equivalence" is a scam -- two new papers http://www.gmfreecymru.org/pivotal_papers/substantial_equivalence.html
(6) The Norwegian Gene Technology Act incorporates this clause:
(http://www.regjeringen.no/en/doc/Laws/Acts/gene-technology-act.html?id=173031 ): "In deciding whether or not to grant an application, considerable weight shall also be given to whether the deliberate release will be of benefit to society and is likely to promote sustainable development."
(7) Urgent Scientific and Policy concerns about the new Draft GMO Regulation. OPEN LETTER 27th February 2010 http://www.gmfreecymru.org/open_letters/Open_letter28Feb2010.html
(8) US scientists complain about GM research blocking Biotech companies limiting independent GM analysis http://tiny.cc/7Pkwn GM crops: Battlefield, by Emily Waltz Nature 461, 27-32 (2009) doi:10.1038/461027a, 2 September 2009
(9) Summary Note-- ENVI Delegation to the European Food Safety Authority (EFSA), Parma, 23-25 April 2010 (pdf)
(10) Monsanto 'faked' data for approvals claims its ex-chief Dinesh C. Sharma India Today, 9 February 2010: http://indiatoday.intoday.in/site/story?sId=83093&secid=120&utm_source=twitter&utm_medium=twitterfeed
www.gmfreeireland.org GERMAN MON810 FEEDING TRIAL RESULTS ARE WORTHLESS http://www.gmfreecymru.org.uk/news/Press_Notice10Dec2009.htm
Monsanto pulls GM corn amid serious food safety concerns
SECRET MONSANTO GM POTATO STUDY SUPPRESSED FOR 8 YEARS GM Potatoes are "unfit for human consumption" -- Press Notice from GM Free Cymru. 16th February 2007 http://www.gmfreecymru.org.uk/news/Press_Notice16Feb2007.htm
THE SYNGENTA DODGY DOSSIER http://www.gmfreecymru.org.uk/pivotal_papers/syngenta.htm
New investigation slams BT Brinjal food safety studies http://www.gmfreecymru.org.uk/pivotal_papers/slams_BT_Brinjal.html
Exposed: Monsanto's fraudulent safety tests for GM Soy http://www.gmfreecymru.org.uk/pivotal_papers/exposed.htm