GM Free Cymru

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

Presentation to Petitions Committee, 27th May 2013

This Petition relates to The Draft Implementing Regulation on GMO assessment (1), which was designed -- against the public interest -- to simplify and speed up the regulatory / approvals process, with a view to harmonising or synchronising the assessment process on both sides of the Atlantic. It is not based upon sound science, but upon political expediency (2). We also object to the improper role played by EFSA in the drafting of this Regulation, and we object to the high degree of discretion which EFSA will in future exercise in the assessment and risk analysis process (3), given that organization's known bias towards industry and a predisposition to consider GM crops and foods as inherently safe.

On 25 Feb 2013 Corporate Europe Observatory reported on a protest outside the closed-doors meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH) in Brussels at which the Draft Implementing Regulation was discussed and voted on (4). The minutes of the meeting (5) at which the "the revised version of the document" was discussed have now been published, but we still do not know what that revised version looked like. It was not released prior to the meeting, and has not been released subsequently, although 3 months have passed. In the meantime, EFSA's GMO Panel is using it as guidance in the GMO assessment process. This is devious and secretive -- and completely unacceptable to those of us who believe in democratic accountability and transparency.

Protests from NGOs about the unscientific nature of the Draft Implementing Regulation (6) have been completely ignored, as far as we can make out. Also, no account has been taken of public expressions of concern about GMOs in Europe (7), or of the Avaaz Petitions (8a) (8b) (8c) which now contain well over over three million signatures. (The new rules for ECIs came into force in April 2012.)

EFSA and DG-SANCO, in their ongoing assessments of GMOs, have also ignored calls from many NGOs for a moratorium on GM approvals in the light of powerful evidence now appearing in the peer-revoiewed literature attesting to serious health damage associated with GMOs and Roundup in particular. The new science is of grave concern to millions of well-informed European citizens -- but we see no sign of due deliberation or precaution on the part of the regulators (9). Also, we have drawn the attention of the Commission to evidence coming out from the Danish pig farming and poultry farming industry which suggests strongly that animal health and welfare is negatively affected when the animals are fed on a diet incorporating GM soy with Roundup residues (10). This evidence is supported by a great deal of anecdotal evidence from the United States, and by new work on the links between GM feed, Roundup residues and alterations to the animal immune system leading to increased susceptibility to various pathogens. If we and independent scientists know about this work and devote time to assessing its reliability, where are EFSA and DG-SANCO? And where is the Precautionary Principle?

The "summary report" of the Standing Committee (SCFCAH) meeting of 25 Feb 2013 was a travesty, "based on the comments received from the Member States and from third countries" (which third countries?). Specifically mentioned (5) were the supposed lack of a scientific justification for obligatory 90-day feeding studies; the need to reduce, refine and replace animal feeding studies; and 'the unjustified burden to applicants" arising from the feeding study requirement, leading to authorisation delays. Member state comments supported these points, except for Greece and Hungary, whose representatives argued for 90-day feeding trials for stacked events. Thus the Summary Report portrayed a consensus of concern about over-regulation, and a wish from member states for 90-day feeding studies to be made voluntary rather than obligatory.

However, the Commission and EFSA made no mention at all of the heavy criticisms that have come from consumer groups and NGOs (and also represented in this Petition) about the unacceptably high degree of discretion which will be exercised by EFSA in determining the nature of dossier evidence required in support of future GMO applications; the scientifically absurd pretence that stacked events are "already understood" and therefore need no additional feeding trials (11); the comprehensive abandonment of the Precautionary Principle (12); the failure to consider the "indirect effects" of GMO farming associated with Roundup and other chemical residues (13) and the continuing acceptance of studies conducted on surrogate proteins as substitutes for whole GMO foods as they will enter the food chain. As we have pointed out in previous presentations (March 2011 and December 2012) there are other major points of concern as well -- all now completely ignored by DG-SANCO and EFSA. In addition, as EFSA knows full well, the long-term animal feeding study published by Seralini and colleagues in 2012 suggests that 90-day feeding studies are inadequate to fully pick up chronic toxicity (14), and that full lifetime studies should be mandatory.

Finally, we accuse EFSA and DG-SANCO of ignoring the accumulating evidence of harm associated with GMO animal feed and with Roundup residues (15). While they have been concentrating on reducing the regulatory burden for GMO patent holders, we see a disaster of epic proportions unfolding in the United States and Canada, where Roundup-resistant "superweeds" and "superbugs" are rampant and where animal health issues are reaching the top of the scientific agenda. The negative ecological impacts of extensive GM farming are now beyond doubt. We also see an unnerving correlation between the accelerating rise in GMO plantings and the accelerating rise in certain human ailments -- just as there is a link between GM soy monocultures and cancers in Argentina, Brazil and Paraguay. It is almost as if the Commission and EFSA consider these impacts to be occurring on another planet; and we accuse them again a implementing a "don't look -- don't see" policy which effectively abandons ethics and betrays the people of Europe who do have a highly developed awareness of global ecology and a sense of compassion for those who suffer abroad in the cause of "cheap food."

We are now quite certain that the Commission and EFSA, while arguing that everything they do is driven by "sound science", are actually driven by political and commercial considerations (16). We accuse them of being influenced above all else by American and WTO diplomatic pressure and by the intense lobbying of the biotechnology giants, who all want a dramatic reduction in the EU "regulatory burden", whereas they should be driven above all else by the need to protect the health of European citizens. They appear to be incapable of looking sideways or beyond the confines of their own very narrow GMO assessment brief. The members of EFSA's GMO Panel seem to think of themselves as belonging to a scientific elite, whose judgments are infallible and whose guiding principle is that GMOs are entirely safe. They seem to have lost the ability to accept scientific criticism and even to enter into a meaningful scientific debate. In particular, they seem to be incapable of accepting that independent scientists may be right in their suggestions of harm associated with certain GMOs and Roundup herbicide, and that Monsanto-sponsored scientists may -- under commercial pressure -- even be prepared to commit scientific fraud.

In conclusion, we once again accuse DG-SANCO and EFSA of overseeing a dramatic reduction in the quality of the science used in the assessment of new GMO varieties (particularly for stacked events) and of pandering to political and commercial pressures. And we accuse EFSA once again of ignoring most of the conclusions and recommendations of the Environment Council meeting of December 4th 2008. We therefore ask Parliament to reject the GMO Implementing Regulation and to insist on a full GMO moratorium while the science of GMOs is comprehensively reassessed.

Brian John on behalf of the 12 petitioners

NOTES (1) Formal Protest from Scientists: Commission Regulation on Implementing Rules for GM applications and assessments OPEN LETTER 23rd February 2010 Draft COMMISSION REGULATION on implementing rules concerning applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Regulations No (EC) 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)

(2) Approval of GMO crops: US and EU seek agreement, EU farmersʼ associations press for speed EU Commission’s draft GMO Regulation -- Charter for the GM industry September 2012

(3) environmental-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"GMO expertise: assessment process turns its back on science" Dr. Frédéric Jacquemart‎

(4) Action in Brussels on GMO risk assessment meeting Subject for determination: Draft Commission implementing Regulation on implementing rules concerning applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Regulations No (EC) 641/2004 and (EC) No 1981/2006. Standing Committee on the Food Chain & Animal Health Role of ILSI and Harry Kuiper in drafting this Regulation:

(5) Standing Committee on the Food Chain & Animal Health -- Summary Report (Minutes are not available)

(6) Protests from NGOs and consumer interests: EU Commission's draft GMO Regulation -- Charter for the GM industry (September 2012) Earth Open Source WARNING OVER "HIDDEN AGENDA" IN OVERHAUL OF GM APPROVALS SYSTEM 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

(7) Eurobarometer poll 2010: 61% were opposed to GM crops and foods, as against 23% in favour. In 2005 the percentage of those opposed was 57%, so there is a rise in public concern. In the UK 79% of respondents in a BBC poll were opposed to GM trials, and other polls have shown that around 70% of the British public do not want GM crops to be grown commercially in the UK.

(8a) Over a million Europeans call for GM crop freeze: "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." Now signed by 1,229,495 European citizens. (as at 18 May 2013.) First ever petition presented to the Commission as a ‘European citizens’ initiative’ -- it is uncertain whether the Commission has accepted this, given that the new ruled did not come into force until April 2012.

(8b) Current Avaaz Petition: "Following Prof. Gilles-Eric Seralini’s 2012 study, we demand an immediate freeze on approvals of genetically modified (GM) foods until mandatory, transparent, and independently conducted long-term tests have been put in place internationally. We also demand that GM foods already on the market be tested for long-term safety." (8c) Current Avaaz Petition: "As concerned citizens, we urge you to take the lead to fix European patent law by calling on the Administrative Council of the European Patent Organisation to close the loopholes that allow corporations to patent plant varieties and conventional breeding methods. Clear and effective safeguards and prohibitions are needed to protect consumers, farmers and breeders from the corporate takeover of our food chain." 2,011,973 signatures as at 19 May 2013.

(9) "Safe" Levels of Round-Up Weedkiller and GM Corn Found to Cause Tumours and Multiple Organ Damage Teratogenic Effects of Glyphosate-Based Herbicides: Divergence of Regulatory Decisions from Scientific Evidence M Antoniou, MEM Habib, CV Howard, RC Jennings, C Leifert, RO Nodari, CJ Robinson and J Fagan J Environ Anal Toxicol S4:006. doi:10.4172/2161-0525.S4-006 Confirmed: Roundup is more toxic than glyphosate Mesnage R., Bernay B., Séralini G-E. (2013, in press). Ethoxylated adjuvants of glyphosate-based herbicides are active principles of human cell toxicity. Toxicology Increased Cancer Burden Among Pesticide Applicators and Others Due to Pesticide Exposure Michael C. R. Alavanja, Dr PH; Matthew K. Ross, PhD; Matthew R. Bonner, PhD, MPH CA Cancer J Clin 2013 Jan 15. doi: 10.3322/caac.21170. 23 pp. Heinemann, J. A., Agapito-Tenfen, S. Z. and Carman, J. A. A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments. Environ Int in press. Teratogenic Effects of Glyphosate-Based Herbicides: Divergence of Regulatory Decisions from Scientific Evidence Antoniou, MEM Habib, CV Howard, RC Jennings, C Leifert, RO Nodari, CJ Robinson and J Fagan J Environ Anal Toxicol S4:006. doi:10.4172/2161-0525.S4-006 Review article: Glyphosate's Suppression of Cytochrome P450 Enzymes and Amino Acid Biosynthesis by the Gut Microbiome: Pathways to Modern Diseases by Anthony Samsel and Stephanie Seneff , Entropy 2013, 15, 1-x manuscripts; doi:10.3390/ e140x000xentropy ISSN 1099-4300 Mezzomo, B. P., et al. (2013). Hematotoxicity of Bacillus thuringiensis as spore-crystal strains Cry1Aa, Cry1Ab, Cry1Ac, or Cry2Aa in Swiss albino mice. J Hematol Thromb Dis 1(1). Study available here in full: Hidden Viral Gene Found in GMOs: Q&A

(10) Antoniou M, Habib M, Howard CV, Jennings RC, Leifert C, Nodari RO, Robinson C, Fagan J. Roundup and birth defects: Is the public being kept in the dark? Earth Open Source, 2011. GM SOY – Sustainable? Responsible? by Michael Antoniou, Paulo Brack, Andres Carrasco, John Fagan, Mohamed Habib, Paulo Kageyama, Carlo Leifert, Rubens Onofre Nodari, Walter Pengue 2010 GLS Gemeinschaftsbank eG and ARGE Gentechnik-frei Visceral botulism at dairy farms in Schleswig Holstein, Germany - Prevalence of Clostridium botulinum in feces of cows, in animal feeds, in feces of the farmers, and in house dust by Monika Krüger, Anke Große-Herrenthey, Wieland Schrödl, Achim Gerlach, Arne Rodloff Anaerobe 18 (2012) 221e223

(11) Lawsuit filed against EU authorisation of genetically engineered soybeans Environmental organisations and scientists jointly bring the case to the European Court of Justice -- partly based on the failure of EFSA to consider combinatorial effects in stacked events.

(12) Anne Glover, the EC's Chief Scientific Advisor, apparently thinks that the Precautionary Principle no longer applies, as far as GMOs are concerned: She appears to be recommending that a key part of the Directive should be ignored -- in other words, that European law should be broken.

(13) Health hazards of Roundup & glyphosate Sickness and death in animals exposed to Bt cotton Open Letter: Commission accused of "Don't Look, Don't See" policy on GM soy. How Indian Farmers were lured into the GM technology trap Argentina's Roundup Human Tragedy Ten years of GM soy and glyphosate poisoning have escalated the rates of cancer and birth defects. Claire Robinson Report from the 1st NATIONAL MEETING OF PHYSICIANS IN THE CROP-SPRAYED TOWNS Faculty of Medical Sciences, National University of Cordoba. August 27th and 28th 2010, University Campus, Cordoba Coordinators: Dr. Medardo Ávila Vazquez, Prof. Dr. Carlos Nota. The report can be downloaded from

(14) 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, Hundreds of scientists defend Seralini against EFSA and other GM apologists 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:

(15) Mounting scientific evidence on adverse impacts of GM; a compilation of 300 key articles GE Crop Risk Assessment Challenges: An Overview Dr. Charles Benbrook | May 6, 2013 Opinion Environment International, Volume 37, Issue 4, May 2011, Pages 734–742 A literature review on the safety assessment of genetically modified plants José L. Domingo and Jordi Giné Bordonaba