Literature

Petition presentations in Brussels -- 3rd December 2012

On 3rd December Brian John was in Brussels at the invitation of the EU parliamentary Petitions Committee to pursue two Petitions which are still alive - one relating to the food safety rights of EU citizens, and the other relating to the shortcomings of the Draft Implementing Regulation for the assessment of GM products. Both of the petitions are really to do with the bias and corruption within EFSA and DG-SANCO, which work together very closely to protect and promote the interests of the GM industry while pushing food safety and the rights of citizens far down on their lists of priorities. It was Brian's third verbal presentation on Petition 813-08 (which has been in the system now for 4 years) and his second presentation on Petition 436-10, submitted jointly with 13 other scientists two years ago. The petitions are both still "alive" because the Petitions Committee presumably feels that the EC and EFSA have still not satisfactorily dealt with the matters raised. This is a protracted business -- the wheels of Europe grind very slowly..........

In the first presentation yesterday to the Committee, Brian accused EFSA of endangering the health of citizens by blindly pressing ahead with positive assessments for GM crops in the face of accumulating evidence of harm -- specifically in the recent paper by Seralini et al which showed toxic effects associated with Roundup and NK603 maize when these were incorporated into the feed of rats during the first ever long-term feeding and toxicology study. He also accused EFSA of conspiring with others to "kill off" the study and to discredit the authors since its undeclared priority was to protect the reputations of officials who have become entirely convinced over the years that GM products are harmless -- whatever the evidence might show. He claimed that EFSA was more interested in political expediency and self preservation than in any serious science -- with the result that European citizens are being placed seriously at risk.

Eric Poudelet from DG-SANCO responded on behalf of the Commission, and failed to address any of the serious points made by the Petitioner. He simply repeated the standard EC line that EFSA is as independent as it can be, that membership of EFSA is decided in a very rigorous fashion, that EFSA panel members need to be "experts" who may or may not have links with industry, and that EFSA always tries to operate in as transparent a fashion as it can, given the confidentiality rules imposed at a Commission level. He made the highly disingenuous point that EFSA is criticised by other countries (ie USA, Canada, Australia and New Zealand) for holding to a policy that is too severe on GMOs, and pretended that this was also the view of "the scientific community" (whatever that is supposed to be). Finally he confirmed, while trying to do the opposite, that EFSA had organized a stitch-up over the Seralini paper, rushing to discredit the research within the space of just a few weeks.

There was no formal response from EFSA, but comments from the floor from MEPs were universally hostile towards EFSA and the Commission. The main points made by seven or eight MEPs were that the Precautionary Principle is of huge importance, and must not be abandoned; that if there is any risk at all that GMOs and Roundup are toxic to humans, then prudence has to be the watchword; that EFSA's independence and impartiality were seriously in doubt; that EFSA's response to the Seralini paper had been rushed through when a much more considered approach would have been wiser; that there should be a much greater attempt to canvass the views of genuinely independent scientists on the reliability (or otherwise) of the Seralini study; that there is huge scientific uncertainty in the area of GMOs (for example re the impact on bees, and in the matter of contamination and coexistence); and that EFSA itself is a major problem which the Parliament has to deal with. Keith Taylor MEP forcefully made the point that ALL GMOs intended to enter the food chain should undergo lifetime animal feeding studies on the lines laid down by the Seralini research group.

The Chair took the view, following the discussion, that neither EFSA nor the Commission had adequately dealt with the points made by the Petitioner, and that the Petition should be kept "alive" while further attempts were made to elicit sensible responses and to obtain a clear demonstration that citizen's rights were being protected.

Brian was then invited by the Chair to present his second Petition (concerning the inadequacies of the Draft Implementing Regulation on GMOs) although he was only given a couple of minutes to try and abbreviate what he had written down -- since the session was running behind time. His main points were that EFSA has "sold" the Draft Implementing Regulation and the new EFSA Guidelines on GMO assessments as a "tightening up" of the rules for the protection of the people of Europe -- whereas any careful reading of the documents will confirm that precisely the opposite is the case. The new rules are actually designed to ease the regulatory burden on GMO applicants, and to enable fast-track and simplified approvals to be brought in. Furthermore, the most dangerous aspect of the proposed new rules is the extraordinary amount of discretion built into them, enabling EFSA to make deals with applicants and even to dispense with safety or toxicology studies altogether. This is clearly a very dangerous attempt by EFSA to greatly extend its power base, and to take unassailable control of the GMO agenda. In spite of the rather unsatisfactory and rushed presentation of a few of the key points (see the prepared talk below) it did not matter, since it was already clear that the Chair and the Secretariat had decided that this Petition should also be "kept alive" while EFSA and the Commission are challenged to be mindful of the extreme disquiet about GMOs and EFSA on the part of both the public and the members of the Petitions Committee. In his response for the Commission, Eric Poudelet tried to reassure those present that EFSA Guidelines and the Draft Implementing Regulation were being considered in a fully transparent fashion and that wide consultations were appropriate and ongoing. He confirmed, much to the surprise of some of those present, that the Commission is in a "reflective phase" at the moment, and that the process of approving the Draft Regulation is effectively "frozen" while the EC gives full consideration to the ramifications of the Seralini study.

All in all, the Petitions Committee gave a clear indication that it is rather displeased with both the Commission (DG-SANCO) and EFSA for their ongoing arrogance, their simplistic view on the conduct of science, and their refusal to admit to any safety problems with respect to GMOs and Roundup, simply because the GMO Panel tells them that GM products are safe and that everything is under control. We hope, therefore, that the Committee will consult again with the Environment Committee and that it will formally ask the Commission not to approve the Draft Implementing Regulation until there has been wider canvassing of scientific opinion and until the Seralini study has been much more carefully assessed -- and preferably repeated. We are hopeful that the Petitions Committee will make a formal invitation to Prof Seralini to attend a joint meeting with the Environment Committee, so that MEPs can hear for themselves what the findings of the 2-year rat feeding study really mean for long-term public health. In that context, we think that the Commission would be very ill-advised to do anything precipitate on any issue to do with GMOs.........

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Title of Petition 813-08: The importance of impartiality within EFSA & the food safety rights of EU citizens Name: Brian John Postal Address: Trefelin, Cilgwyn, Newport, Pembrokeshire SA42 0QN, Wales, UK Nationality: Welsh

3rd VERBAL PRESENTATION 3rd December 2012

I am grateful for the opportunity to speak to you again. My concerns arise out of the fact that EFSA's GMO Panel routinely makes recommendations and decisions affecting the health of millions of EU citizens, in spite of the fact that it is mistrusted by NGOs and the public, and heavily inﬂuenced by the GM industry (1). I am also disillusioned because the Commission has pressed ahead with GMO consents in spite of abundant evidence of direct and indirect harm to the health of mammals and to the environment (2). In addition, both EFSA and the Commission have ignored public animosity towards GM foods and crops, as shown in the Avaaz Citizen's Petition with more than 1.2 million signatures (2).

Last year I listed six points at issue (3), including the defective and biased scientiﬁc methods used by EFSA in recommending approvals for GM varieties; the dependence on industry-generated advocacy science and on non-replicable experiments, in deﬁance of good practice and scientiﬁc ethics; and the pro-industry bias within the GMO Panel. EFSA and the Commission have done nothing to address my concerns, although some small moves have been made to address the issue of "revolving doors" and GM industry inﬂuence in the areas of policy and regulation. (4)

Recently Prof GE Seralini et al published the ﬁrst long-term feeding and toxicity study (5) to show that both Roundup herbicide and GM maize NK603 were toxic to rats when included in small quantities in their diets. The paper, in a peer-reviewed journal without any "red light" alerts from referees, was fastidious and carefully written, and it reported on a two-year experiment conducted to the highest scientiﬁc and ethical standards. Its results came as no surprise to scientists who have known for many years that Roundup is highly toxic to non-target organisms, and that GM plants and products in animal feed trigger off cell changes, reductions in fertility and damage to vital organs. These effects are biologically predictable and well recorded (6), even though EFSA and the EC have consistently turned a blind eye to them.

When the Seralini paper was published, we asked the EC to examine the Seralini ﬁndings very carefully, to place an immediate moratorium on GM consents, to ask for (and if necessary, to fund) a repeat of the French research team's experiment, and to ask EFSA to re-examine past GMO "opinions" (especially relating to NK603) with a view to determining the reliability or otherwise of the Seralini research results. The Commission did indeed ask for an opinion on the Seralini paper, but to my astonishment EFSA issued a number of new GMO opinions in the following weeks as if nothing had happened, and on 18 October, only a month after the publication of the new research, the Commission gave market approval for a Syngenta GM maize variety (7). This was not only insensitive and scientiﬁcally irresponsible, but it demonstrated that the Commission and EFSA have now completely abandoned the Precautionary Principle, in contravention of the Directives.

Worse was to come. As we pointed out in our letter to the Petitions Committee in October, the EFSA response to the Seralini paper was almost instantaneous. It slipped into "damage limitation" mode, determined from the outset to ﬁnd fault with the paper and to discredit the authors. It published an interim review (8) which was disrespectful, complacent and disingenuous. It made a number of spurious "scientiﬁc" points which have subsequently been given short shrift by the authors of the paper (9). It also applied blatant hypocrisy and double standards in its critique, criticising the authors for failing to work to certain laboratory protocols which it has apparently been perfectly happy to do without in studies reported by Monsanto. It also demanded sight of full data sets from the French team, having done without such data sets in the Monsanto NK603 dossier.

And even worse was to come, in a leak via a Dutch government web site (10). It emerged that EFSA had set up a "multidisciplinary task force" charged with attacking the Seralini study on all fronts (11). This group involved Andrew Chesson, Per Bergman and a group of civil servants from EFSA, some of whom had clear conﬂicts of interest. On 28th September these ofﬁcials conducted a teleconference with selected civil servants from four member states, to come to a common view on the Seralini study and to eliminate dissenting views (10). This teleconference was unconcerned about health and safety issues; its brief was to limit the damage to EFSA and the Commission, to achieve politically expedient outcomes, and to protect the reputations of those who have promoted GMOs in Europe over the past decade. While this group was getting down to work, the EC's media outlets were working overtime to discredit Professor Seralini and his colleagues and to question their scientiﬁc competence (12).

We know the names of those responsible for this campaign, which culminated in the EFSA statement on 28th November. (13) Where did their mandate come from, and by what right did they give an EU assessment of the paper in question? Were the other member states consulted? The "EU opinion" determined by this small self-selected group was promoted via the press ofﬁce without any consultation, in the full knowledge that it would be accepted by a gullible media as the authoritative statement of the position of the Commission and the Parliament. This was an outrageous abuse of power.

On the basis of the above, I now accuse the Commission and EFSA of conspiring together to destroy the credibility of a highly-qualiﬁed and fastidious research team which happens to have discovered something uncomfortable; of seeking to cover up the shortcomings of the EFSA assessment process for NK603 and the serious and systematic scientiﬁc failures over a decade of GM consents (14); and of demonstrating a total disregard for scientiﬁc ethics and for the safety of European consumers.

My family and I had assumed that the EC would wish to treat public health as a priority. Instead, it appears that its chief priority is the protection (at huge public expense) of a corrupt GM industry, which produces nothing at all of any beneﬁt to consumers, and the protection of the reputations and self-esteem of EFSA's ofﬁcials and GMO Panel members. They do not deserve to be protected by anybody, since they are in my view guilty of ongoing extreme negligence, bias and even incompetence in their work. The GMO Panel is not ﬁt for purpose, and it must be wound up before it does any more harm.

What can the Petitions Committee and the Parliament do about this? I am not sure, but I plead for urgent action to be taken against the Commission and EFSA, who do not see what others see, because they do not wish to look.

Dr Brian John, GM-Free Cymru (Wales)

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NOTES

(1) http://www.gmfreecymru.org/petition.html
http://www.corporateeurope.org/agribusiness/content/2011/03/conﬂicts-interest-efsaboard-letter
http://www.corporateeurope.org/content/2011/02/efsa-conﬂicts-interest-board
Serial conﬂicts of interest on EFSA's management board European Food Safety Authority: A playing ﬁeld for the biotech industry Testbiotech Background Report 1-12-2010 Standards for risk assessment massively inﬂuenced by industry http://www.testbiotech.org/en/node/431

(2) To EC President Jose 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. http://www.greenpeace.org/eu-unit/press-centre/press-releases2/ﬁrst-citizens-initiative
http://www.avaaz.org/en/eu_gmo/

(3) http://www.gmfreecymru.org/petition/petition_813-08.html

(4) EU agencies - conﬂicts of interest Resignation of EFSA chairperson vindicates EP efforts to tackle conﬂicts of interest at EU agencies
http://www.greens-efa.eu/eu-agencies-conﬂicts-of-interest-7147.html
Another EFSA scandal -- chair is forced to resign
http://www.gmfreecymru.org/news/Press_Notice10May2012.htm
EU watchdog forced out over links to 'Frankenstein food' ﬁrms The EU Ombudsman criticised EFSA for mishandling the case of Suzy Renckens who went from EFSA's GMO panel to become a lobbyist for Syngenta. http://www.corporateeurope.org/pressreleases/2012/european-food-safety-authority-admits-failure-revolving-doors http://www.corporateeurope.org/blog/new-brieﬁng-international-life-sciences-institute-ilsi-corporate-lobbygroup

(5) Séralini, G-E., E. Clair, R. Mesnage, S. Gress, N. Defarge, M. Malatesta, D. Hennequin, J. Spiroux de Vendômois. 2012. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modiﬁed maize. Food Chem. Toxicol. 19 September 2012 http://www.sciencedirect.com/science/article/pii/S0278691512005637

(6) Antoniou M, Habib MEM, Howard CV, Jennings RC, Leifert C, Nodari RO, Robinson CJ, Fagan J (2012) Teratogenic Effects of Glyphosate-Based Herbicides: Divergence of Regulatory Decisions from Scientiﬁc Evidence. J Environ Anal Toxicol S4:006. doi:10.4172/2161-0525.S4-006.
http://www.omicsonline.org/2161-0525/2161-0525-S4-006.php?aid=7453
Antoniou, M., M. Habib, et al. (2011). Roundup and birth defects: Is the public being kept in the dark?-- Earth Open Source. http://bit.ly/IP2FWH
http://www.gmfreecymru.org/pivotal_papers/danish_dossier.html http://www.gmfreecymru.org/pivotal_papers/gm_food_dangerous.html
Why GE Food is Dangerous
http://www.gmfreecymru.org/pivotal_papers/BT_toxin.html
Environmental and health impacts of GM crops - the science http://www.gmfreecymru.org/pivotal_papers/environmental_and_health_impacts.html
Ewen, Stanley W.B. and Arpad Pusztai. 1999a Effect of diets containing genetically modiﬁed potatoes expressing Galanthus nivalis lectin on rat small intestine. The Lancet 354 (9187):1353-1354 Ewen, Stanley W.B. and Arpad Pusztai. 1999b. Health risks of genetically modiﬁed foods. The Lancet 354(Issue 9179):684.

(7) EFSA GMO Newsletter September/October/November 2012 Submitted by Testbiotech on 19. November 2012 - 11:33 http://www.testbiotech.org/en/node/741

(8) EFSA's preliminary review of the Seralini paper, dated 4th October: http://www.efsa.europa.eu/en/efsajournal/pub/2910.htm

(9) The response of the Seralini team to the points made by EFSA: EFSA slammed for "institutionalised pseudo-science" after rat study review http://www.gmfreecymru.org/documents/efsa_slammed.html http://www.criigen.org/SiteEn/index.php? option=com_content&task=view&id=368&Itemid=1 http://independentsciencenews.org/health/seralini-and-science-nk603-rat-study-roundup/#comment-4292
Seralini and Science: an Open Letter
http://www.gmfreecymru.org/news/Press_Notice14Nov2012.html
Hundreds of scientists defend Seralini against EFSA and other GM apologists

(10) https://zoek.ofﬁcielebekendmakingen.nl/blg-187499.html (The ofﬁcials involved came from France, Belgium, Netherlands, and Germany)

(11) There was no way that EFSA could have contemplated anything different, since to admit to any merit in the Seralini study would have been to admit to serious shortcomings in the initial EFSA assessment of NK603 and to major failings in the EU assessment of Roundup herbicide as well. EFSA therefore decided to be judge, jury and executioner, and to align itself with the GM industry spokesmen in seeking to bury the Seralini study and to discredit its authors.

(12) Quote: "Under the leadership of the Director of Scientiﬁc Evaluation of Regulated Products, a group of EFSA scientists, with expertise in biostatistics, experimental design, mammalian toxicology, biotechnology, biochemistry, pesticide safety assessments and GMO safety assessments, carried out the initial review. A member from EFSA's Panel on Genetically Modiﬁed Organisms (GMO) and a member from EFSA's Plant Protection Products and their Residues (PPR) Panel were asked to peer review the paper prior to its publication." http://www.efsa.europa.eu/en/faqs/faqseralini.htm#13 It is obvious that everybody involved in this "review" process has been involved in the past in promoting the view that all of the GMOs considered for EU consents are "just as safe as their conventional counterparts." The whole process has been heavily biased, and the review outcomes have been predetermined. http://www.efsa.europa.eu/en/efsajournal/pub/2910.htm http://www.efsa.europa.eu/en/press/news/121004.htm (4th October 2012)

(13) The EFSA statement entitled "Final review of the Séralini et al. (2012a) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology" was published on November 28th 2012, together with an "Annex" containing the opinions of selected member states. The accompanying press release was widely distributed by the EFSA Media Relations Ofﬁce under the heading "Séralini et al. study conclusions not supported by data, says EU risk assessment community." The so-called "EU risk assessment community" was nothing of the sort -- it was a self-appointed kangaroo court which had no mandate to advertise itself in that way, and no mandate to speak on behalf of the EU or the member states. Some of those involved had obvious conﬂicts of interest. Their document is one of the most despicable, arrogant and complacent pieces of pseudo-science that I have ever seen. It is clear that the drafting team conspired from the outset to ﬁnd fault with the Seralini study from every possible standpoint and to defend the EFSA position on NK603 and Roundup herbicide -- which is that they are essentially harmless. The drafting team speciﬁcally refused to revisit the old EFSA safety evaluation of NK605 or any of the stacked events linked to it; it ignored the points made by Seralini et al
(http://dx.doi.org/10.1016/j.fct.2012.11.007) in their "answers to critics" on 9th November; it made no allowance whatsoever for the fact that there are at least ﬁve other publications pending from the Seralini team, which will no doubt allay many matters of concern; it attacked the study on the spurious and petty basis that full data sets were not published in a journal article; its concentration on "statistical shortcomings" was disingenuous in the extreme; it failed to show any respect for the fact that this was the ﬁrst ever long-term feeding study of this type; it attacked the studyʼs "failings" as as carcinogenicity study while failing to recognize that it was in fact a general toxicity study; it failed to recognize that the study was examining the effects of Roundup, not glyphosate; it ignored the almost intolerable degree of secrecy which had to surround this execution of the study, for fear that it would be sabotaged; and the text consistently demonstrated hypocrisy of the ﬁrst order, in demanding levels of scientiﬁc precision and data provision which it conspicuously failed to ask for in the original Monsanto dossier on NK603. Most concerning of all in the text is the apparent absence of any concern for public health, or any awareness of the Precautionary Principle. http://www.efsa.europa.eu/en/press/news/121128.htm
http://www.efsa.europa.eu/en/efsajournal/pub/2986.htm
http://www.efsa.europa.eu/en/efsajournal/doc/2986ax1.pdf
Corporate Europe Observatory: "EFSA has chosen to fan the ﬂames of public controversy by publishing a radically one-sided assessment putting the entire blame on Séralini, applying a level of scientiﬁc standards never reached by the Monsanto study on NK603 it accepted for its EU authorisation and ignoring some national agencies' calls to more research and a review of GMOs and pesticides' risk assessment guidelines." http://corporateeurope.org/sites/default/ﬁles/attachments/EFSA%20and%20S%C3%A9ralini.pdf

(14) As at August 2012, 46 GM varieties had been authorised for usage in food and feed within the EU. Most of them are for import and processing, but two are authorised for cultivation: Monsantoʼs Maize MON810 and the BASF potato "Amﬂora". The 46 events include the following species: 26 maize, 8 cotton, 7 soybeans, 3 rapeseed, 1 potato, 1 sugar beet. The events can be divided into four groups of technical traits (one of which overlaps with two other groups): 8 events producing insecticidal toxins, 15 events tolerant to herbicides, 22 events a combination of insecticidal and herbicide tolerant plants (stacked events), and others: 1 potato producing starch for industrial use, 1 rapeseed producing infertile pollen. (Information: Testbiotech)

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Title of Petition 436-10: Formal protest from scientists against the Commission's draft regulation on implementing rules concerning the applications for authorisation of GM food and feed.

Name: Brian John Postal Address: Trefelin, Cilgwyn, Newport, Pembrokeshire SA42 0QN, Wales, UK Nationality: Welsh Named Petitioners: Dr Brian John, Dr Jose Ramon Olarieta, Prof Brian Wynne, Dr Mae-wan Ho, Prof Jose L. Domingo, Prof Bob Orskov, Prof. Enric Tello, Dr Eva Novotny, Dr Irina Ermakova, Dr Michael Antoniou, Dr Arpad Pusztai, Prof Marcello Buiatti, Dr Susan Bardocz, Dr. Rafael Hachikyan

2nd VERBAL PRESENTATION 3rd December 2012

On behalf of the scientists who submitted this Formal Protest in 2010 (1), and the many more who have expressed support for it, I thank the Committee for the chance to present our case again, on the grounds that our concerns have not been met.

The Draft Implementing Regulation (2) was designed to speed up the regulatory / approvals process, as a gesture to the US administration and the WTO. It is not based upon sound science, but upon political expediency (3). We are not sure what the current status of this document is -- we believe it has received no formal Parliamentary scrutiny, and is being dealt with secretly inside DG-SANCO.

We object to the crucial role played by EFSA in the drafting of this Regulation, and we consider that EFSA now plays an improper and illegal role in the formulation of EU policy on GMOs (4).

EFSA admits to the high degree of discretion it will in future exercise in the assessment and risk analysis process (5). When that discretion is enshrined in law, which is then enforced by EFSA, with a known bias towards industry and a predisposition to consider GM crops and foods as inherently safe, then the citizens of Europe have a right to object.

THESE ARE OUR KEY POINTS:

1. EFSA still sees Comparative Risk Assessment as a standard procedure, just as it still accepts the non-scientific concept of "substantial equivalence", the "concept of familiarity" and the use of the term "generally accepted as safe" (GRAS). (6). Yet the whole point of special regulations for GM food and feed is that changes may occur in a plant, or as a result of herbicide use, that cause allergenicity or toxicity. New allergens or toxic compounds, being unknown, cannot be detected by merely testing for known compounds and key nutrients and assuming that the plant is otherwise safe to consume.

2. The Commission and EFSA have now abandoned the Precautionary Principle, in defiance of Directive 2001/18. (7)

3. The regulation does not require applicants to test for interactions with the environment that may impact the stability, uniformity and composition (and hence the safety) of GM plants.

4. Testing for health risks is still not based on a mandatory graduated process, involving investigations such as toxicity tests on cell cultures in vitro and in vivo, testing of relevant health risks in animal feeding trials, and long term and multi-generational studies.

5. According to this Regulation, both industry and regulators can dismiss statistically significant changes either in a GM plant or in the organs of animals fed on GM products as "biologically irrelevant" without ever defining what that actually means (6).

6. Although 90-day feeding trials are "mandatory for the time being" for new GMOs submitted for assessment and approval, EFSA retains the option of waiving such studies as it sees fit. That is completely unacceptable. In our view, in the light of the recently published study by Seralini et al (8), which confirmed many other independent studies, two-year toxicology studies should be mandatory in all cases. The large body of evidence from the experiences of farmers, both on the performance of GM crops and on the feeding of GM crops to animals, should also be taken into account. (9)

7. It is improper for comparators used in feeding and safety studies to be anything other than the non-GM isogenic parent lines, grown at the same time and in an adjacent location to the tested crop, and it is also unacceptable for surrogate proteins to be used in toxicology testing.

8. The exclusive use of industry-generated data in dossiers provided for the assessment of GM varieties cannot be trusted. We support calls for all testing of GMO varieties to be undertaken in independent laboratories, and paid for by applicants via a publicly-administered research fund. (10)

9. There is no requirement for applicants to use recent technologies, such as metabolic profiling, to see how a GM plant's gene activity and its metabolism are impacted by the method of genetic modification.

10. EFSA's GMO Panel leaves the risk assessment of chemical residues from spraying to the EU and national pesticide regulators. This is against the specific wording of the Directives, which requires all of the "indirect effects" of GM crop plantings and product use to be assessed. (11)

11. Bt toxins are not assessed according to pesticide regulation but by vague deductions as to toxicity. Cry1Ab toxins clearly affect non-target organisms and also impact human cells.

12. Stacked GM events (which are extremely complex) are investigated less rigorously than single events. Indeed, they may -- at EFSA's discretion -- evade toxicological testing altogether. Synergistic and combinatorial effects in the food chain do not have to be investigated and described by the patent holders. (2) (6)

13. Good Laboratory Practice (GLP) standards are only required for new applications. Many existing market authorisations and pending applications are based upon studies of questionable quality.

14. The effects of GM crops on soil are conventionally ignored by EFSA. Studies have found damage to beneficial soil organisms and enhancement of certain pathogens. (12)

15. Post-marketing monitoring of GM varieties is not insisted upon in the field or in the market place. This is probably illegal (13).

16. GM patent holders will not allow their GM raw materials to be used in experiments by non-approved or independent researchers. This breaches one of the fundamental rules of science; but EFSA connives in it, accepting scientific results that might well be fraudulent (14).

CONCLUSIONS

The GM risk assessment process is based upon political expediency, as exemplified by the new Implementing Regulation. It will undermine the existing regulation 1829/2003 and also betray the intent of the Environment Council decisions of December 2008 which demanded a range of clearly itemised reforms (15) (Appendix 2). The new Implementing Regulation, in its current state, will inevitably lead to approvals of dangerous GMO varieties which will have unforseen negative consequences (16). It also incorporates a number of illegal policy changes.

We therefore ask Parliament to reject the new Implementing Regulation, and to take steps to ensure that DG SANCO does not bring it into law (17). EFSA's GMO Panel is entirely unfit for purpose. We call for the immediate winding up of this panel and its replacement by a body whose members have no personal interest in the GM industry and which will place sound science and public health above political expediency.

I am very grateful to the Committee for allowing me to bring this Petition forward on behalf of my colleagues from other parts of Europe, and I respectfully ask for careful consideration of the points I have raised.

Dr Brian John GM-Free Wales

------------- NOTES ----------------

(1) http://www.gmfreecymru.org/open_letters/Open_letter23Feb2010.html
Formal Protest from Scientists: Commission Regulation on Implementing Rules for GM applications and assessments from: Dr Brian John, Dr Jose Ramon Olarieta, Prof Brian Wynne, Dr Mae-wan Ho, Prof Jose L. Domingo, Prof Bob Orskov, Prof. Enric Tello, Dr Eva Novotny, Dr Irina Ermakova, Dr Michael Antoniou, Dr Arpad Pusztai, Prof Marcello Buiatti, Dr Susan Bardocz, Dr. Rafael Hachikyan OPEN LETTER 23rd February 2010 Urgent Scientific and Policy concerns about the new Draft GMO Regulation OPEN LETTER 27th February 2010 to John DALLI http://www.gmfreecymru.org/open_letters/Open_letter28Feb2010.html

(2) EFSA (2011) European Food Safety Authority, Guidance on the submission of applications for authorisation of genetically modified food and feed and genetically modified plants for food or feed uses under Regulation (EC) No 1829/20031 EFSA Journal 2011;9(7):2311. [27 pp.] doi:10.2903/j.efsa.2011.2311 Available online: www.efsa.europa.eu/efsajournal EU Commission (2012) Commission Implementing Regulation (…) on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 (…), http://www.testbiotech.org/node/614 WARNING OVER "HIDDEN AGENDA" IN OVERHAUL OF GM APPROVALS SYSTEM http://www.gmfreecymru.org/news/Press_Notice04bJunel2010.htm Wednesday, 03 March 2010 Testbiotech analysis of risk assessment strategies for genetically engineered plants used for food and feed in the EU: Christoph Then for Testbiotech, September 2012 http://www.testbiotech.org/en/node/712

(3) http://www.gmo-compass.org/eng/news337.approval_gmo_crops_us_eu_seek_agreement.html Approval of GMO crops: US and EU seek agreement, EU farmersʼ associations press for speed
http://www.theparliament.com/latest-news/article/newsarticle/eu-defends-balanced-andpragmatic-gm-policy/

(4) European Commission's illegal policy change http://www.indymedia.ie/article/95951

(5) Letter from Elisabeth Waigmann of EFSA to Dorothee Andree of DG SANCO, 15 July 2010, containing Annex 1 -- EFSA responses to the points raised.

(6) http://www.gmwatch.org/latest-listing/1-news-items/12816-more-gm-trickery-from-efsaenvironmental-risk-assessment-guidelines-are-deeply-flawed
More GM trickery from EFSA: Environmental risk assessment guidelines are deeply flawed Thursday, 20 January 2011, GM Watch Legal Opinion of Paul Lasok QC and Rebecca Haynes "In the Matter of the Proposed Regulation to Amend Directive 2001/18" -- GM Freeze http://www.gmfreeze.org/uploads/lasok_cultivation_summary_final.pdf

(7) Anne Glover, the EC's Chief Scientific Advisor, apparently thinks that the Precautionary Principle no longer applies, as far as GMOs are concerned:
http://www.euractiv.com/innovation-enterprise/commission-science-supremo-endor-news-514072 She appears to be recommending that a key part of the Directive should be ignored -- in other words, that European law should be broken.

(8) Séralini, G. E., E. Clair, et al. (2012). Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food and Chemical Toxicology 50 (2012), pp. 4221–4231 See also: Answers to critics: Why there is a long term toxicity due to NK603 Roundup-tolerant genetically modified maize and to a Roundup herbicide, by Seralini et al, http://www.sciencedirect.com/science/article/pii/S0278691512008149 Hundreds of scientists defend Seralini against EFSA and other GM apologists
http://www.gmfreecymru.org/news/Press_Notice14Nov2012.html AN OPEN LETTER About 200 scientists from 33 countries have written in support of Seralini and his colleagues, and 95 scientists have thus far signed the Open Letter entitled "Seralini and Science" and found here:
http://independentsciencenews.org/health/seralini-and-science-nk603-rat-study-roundup/#comment-4292

(9) See, for example, the following: Danish Whistleblowers reveal links between GM soy, Roundup and health damage in pig herds http://www.gmfreecymru.org.uk/news/Press_Notice29April2012.htm http://www.downtoearth.org.in/content/farmers-tech-trap Sickness and death in animals exposed to Bt cotton http://www.gmwatch.org/index.php?option=com_content&view=article&id=12108 Open Letter: Commission accused of "Don't Look, Don't See" policy on GM soy. http://www.gmfreecymru.org/open_letters/Open_letter18July2012.html How Indian Farmers were lured into the GM technology trap

(10) EU Commission's draft GMO Regulation -- Charter for the GM industry (September 2012) Earth Open Source http://earthopensource.org/index.php/reports/eu-commission-draft-gmo-regulation-charter-for-the-gm-industry
http://bit.ly/OZ3a00
http://www.gmwatch.org/latest-listing/1-news-items/6875-proposal-for-urgentaction -EFSA IS ASKED TO BLOCK ALL NON-REPLICABLE SCIENCE GM Free Cymru, 18th May 2007

(11) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

(12) http://gmwatch.org/component/content/article/13021 Re: Prof Don Huber's Open Letter:
http://www.i-sis.org.uk/newPathogenInRoundupReadyGMCrops.php

(13) Kraemer, L., 2012, The consumption of genetically modified plants and the potential presence of herbicide residues, legal dossier commmissioned by Testbiotech,
http://www.testbiotech.de/sites/default/files Legal_Dossier_Kraemer_Pesticide_RA_PMP.pdf

(14) http://www.gmwatch.org/latest-listing/1-news-items/6875-proposal-for-urgentaction- EFSA IS ASKED TO BLOCK ALL NON-REPLICABLE SCIENCE GM Free Cymru, 18th May 2007

(15) http://www.gmfreecymru.org/news/Press_Notice16Septb2010.htm Council Conclusions on Genetically Modified Organisms 2912th Environment Council meeting Brussels, 4 December 2008 at http://www.consilium.europa.eu/uedocs/cms_Data/docs/pressdata/en/envir/104509.pdf

(16) http://www.gmfreecymru.org.uk/pivotal_papers/health.html Health Effects of Glyphosate Health risks of GM Foods and Crops New legal dossier shows current authorisation practice violates EU law 22. June 2012 Munich/Brussels http://www.testbiotech.de/en/node/675 Commissioner Dalli admits EU food safety regime must change Why glyphosate should be banned http://www.i-sis.org.uk/Why_Glyphosate_Should_be_Banned.php

(17) In a recent development (29 November), Earth Open Source reports: "In September Earth Open Source asked the Commission via Sir Graham Watson MEP if, in the light of Seralini's findings, it had any plans to freeze the progress of the new draft Regulation. EOS has now received Commissioner Sefcovic's reply: "The draft Regulation on applications for authorisation of GM food and feed will further define the requirements for GMOs risk assessment set in Regulation (EC) No 641/2004. Its adoption will therefore contribute to strengthen the protection of human and animal health and the environment in the EU. The drafting of the Regulation included an extensive consultation with Member States, Members of the Parliament and stakeholders during the course of 2011 and 2012." We take this opaque reply to mean that the Commission will not stop or redraft this draft Regulation in light of Seralini's findings. Further, the Commission claims that the draft Regulation actually strengthens GMO regulation........." http://www.gmwatch.org/index.php?option=com_content&view=article&id=14490:efsa-commission-turn-a-blind-eye-to-gmo-dangers
It appears that stakeholder comments have been largely ignored, and that the Commissioner is determined to bring this Regulation into force. In spite of what he says, the Regulation will substantially WEAKEN the protection of human and animal health and the environment. That is the only conclusion to be drawn from a reading of the document.

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APPENDIX 1

The Regulation is unacceptable because it fails to meet the requirements of the following:

Regulation 178/2002 "the Food Safety Regulation": "Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner." (Art. 6, 2). Regulation 1829/2003, "food and feed": Products derived from genetically engineered plants "should only be authorised for placing on the Community market after a scientific evaluation of the highest possible standard." (Recital 9). Directive 2001/18, "deliberate release": The directive requires the examination of the "direct and indirect, the immediate and delayed effects" of the genetically engineered plant on human health or the environment (Annex II), "in accordance with the precautionary principle." (Article 1)

Key concerns expressed in the Original Petition and still not addressed:
SIGNIFICANT SCIENTIFIC AND SAFETY CONCERNS

For more details see here: http://www.gmfreecymru.org/open_letters/Open_letter23Feb2010.html

1. REDUCED VIGILANCE. There is a noticeable lessening of vigilance on GM safety issues.

2. DEROGATIONS AND DEALS. By watering down the regulatory requirements for animal testing, toxicology studies etc, there is a distinct possibility that EFSA can in future make convenient "deals" with applicants to bypass almost all of the studies that should be done.

3. STACKED EVENTS. We have particular concerns about the method proposed for dealing with "stacked event" applications, which involves a "fast track" process with simplified requirements.

4. RESEARCH STANDARDS AND PROTOCOLS. There is a distinct lack of clarity about the precise safety testing regime that should be employed with respect to new GM varieties, which seems to fall far short of Codex Alimentarius standards.

5. CHOICE OF COMPARATORS. There now appears to be too much leeway in the choice of "the conventional counterpart" and additional comparators.

6. SURROGATE PROTEINS. Under "Toxicology" it is proposed to allow "testing of newly expressed proteins" without any instruction or requirement that they have to be isolated or derived from the GM plant itself.

7. INSERTIONAL MUTAGENESIS. The Draft Regulation is vague and complacent on this matter.

8. ANTIBIOTIC RESISTANCE MARKER GENES. We can see no requirement that ARMs (antibiotic resistance marker genes) MUST be removed after initial plant breeding.

9. MOLECULAR CHARACTERIZATION. There is lack of clarity in the Draft Regulation, with EFSA retaining the right to request -- or not request -- specific information.

10. SUBSTANTIAL EQUIVALENCE. The myth of substantial equivalence is maintained, in spite of the fact that there is now overwhelming evidence that GM varieties are substantially different from their isolines.

11. SAFETY STUDIES INVOLVING ANIMALS. The Draft Regs appear to accept the fantasy that short-term nutritional studies are adequate for identifying chronic health effects in mammals.

12. DEPENDENCE ON INDUSTRY STUDIES. In our view all industry-sponsored research on GM safety must be assumed as designed to produce "convenient" results, until it is independently verified.

13. ANALYSES OF RAW DATA. There is no requirement in the Draft Regs for an applicant to release or reveal his test data for peer group or public review. 14. POST-MARKET MONITORING. The arrangements proposed for post-marketing monitoring allow far too much discretion on the part of EFSA and the consent holders.

15. HEALTH IMPLICATIONS. There is no requirement for studies to demonstrate safety in use.

16. RESEARCH BLOCKING. EFSA and the Commission are still conniving in the use of non-replicable science and the blatant blocking of independent research.

APPENDIX 2

Conclusions (unanimous) of Environment Council, 4th December 2008 See also: Council Conclusions on Genetically Modified Organisms 2912th Environment Council meeting Brussels, 4 December 2008 http://www.consilium.europa.eu/uedocs/cms_Data/docs/pressdata/en/envir/104509.pdf

1. There was a re-statement of the precautionary principle as a guiding principle in GMO assessments, on the basis that it has been inadequately used -- or disregarded -- in past decisions.

2. There was a commitment to a strengthening of the environmental impact assessment for GMOs and a strengthening of monitoring requirements.

3. There was a commitment that pesticide-producing GM crops (such as Bt11, 1507 and MON810) should be treated (in the assessment and approval process) in the same way as chemical pesticides.

4. Member states, competent authorities and EFSA were assured that they would from now on have the right to make specific assessments of the impacts of GMOs in specific geographical areas / ecological niches.

5. Responding to the new research on damaging health effects associated with GM varieties, Ministers demanded that if new information becomes available with regard to the risk of the GMOs to human health, the competent authority must prepare an assessment report and indicate how the conditions of the consent should be revised or the consent terminated.

6. For the first time, Ministers specified a role for independent scientists, scientific organizations and NGOs in the GMO assessment process. An important role was accepted for organizations expert in ecological issues. Ministers also asked for effective coordination and cooperation between scientists.

7. For the first time, socio-economic effects arising from the cultivation and / or marketing of GMOs must now be considered as relevant to the assessment process.

8. It was implicit in the drafted document that EFSA'a powers were to be substantially reduced, and EFSA was instructed to revise its GMO assessment procedures by 2010. Henceforth there was a commitment to a key role for member states, including states other than the applicant state.

9. There must now be greater protection from GMOs for special areas -- National Parks and other protected or designated areas. There was an acceptance that GM Free Zones coinciding with these protected areas could be declared and would be respected by the EC as valid.

10. The Ministers insisted on a reform of the secretive and defective assessment process that has until now been operated by EFSA. Member States and the Commission must henceforth ensure that systematic and independent research is conducted on the potential risks involved in the marketing and growing of GMOs. The necessary resources must be secured for such research by the Community and Member States. Most importantly, independent researchers must be given access to all relevant dossier material, while respecting intellectual property rights. Finally, Member States and the Commission must collect and exchange information on this research.

11. Finally, regions and local communities will henceforth have the right to declare GMFree zones.

the community pressure group campaigning to keep Wales free of genetically-modified crops

GM-Free Cymru