GM Free Cymru

3)  REJOINDER from Petitioner, dated 1st May 2009

Regarding the Commission's response to my Petition,  I find it to be complacent and evasive, in that it does not address any of the key concerns raised in the Petition.  It fails to address the issue of "selective advocacy science" which is quite likely to be flawed or even fraudulent;  it does not address the issue of non-replicable science and the blocking of independent research into GM varieties;  and it does not address the ongoing attempts by EFSA to frustrate or prevent full public disclosure of the contents of GMO dossiers.  It simply falls back on platitudes and pretends that EFSA's work is independent and impartial, whereas it patently is not -- which is why there is such disquiet about EFSA throughout the voluntary sector.

I therefore ask the Parliament and the Petitions Committee to reject the Commission response on the following grounds:

1.  With reference to this paragraph:  "The EFSA GMO Panel evaluates the studies submitted by the applicants. The environmental risk assessment takes place in accordance with the thorough criteria established by the principles of Annex II of Directive 2001/18/ EC............"    The whole point is that these criteria are not thorough at all. They allow applicants a huge amount of discretion and even permit scientific fraud.
Many of the tests reported upon in dossiers refer to "surrogate proteins" or to GM constructs simply assumed to be stable and uniform in the GM varieties considered.  For composite materials like food and feed, reductionist approaches testing single components in vitro or in vivo are highly unsatisfactory and cannot clarify important safety issues. In spite of the obvious need, very few studies designed to investigate putative effects of GE nucleic acids or food/feed on potential animal or human consumers have been published in peer- reviewed journals (Domingo, J. L., 2000). A consensus has emerged that the effects observed in some published studies (Fares, N. H. & El- Sayed, A. K., 1998; Ewen, S. W. B. & Pusztai, A., 1999) must be experimentally followed up. To this day, this has not been done by EFSA, nor has EFSA insisted on such work by the applicants for GMO consents.  Most of the animal feeding studies conducted so far have been designed exclusively to reveal husbandry production or nutritional differences between GMOs and their unmodified counterparts. Studies designed to reveal physiological or pathological effects are extremely few, and they demonstrate a quite worrisome trend (Pryme, I. F. & Lembcke, R., 2003): Studies performed by the industry find no problems, while studies from independent research groups often reveal effects that should have merited immediate follow- up, confirmation and extension. Such follow-up studies have not been performed or insisted upon by EFSA. There are two main factors accounting for this situation: The lack of funds for independent research, and the reluctance of producers to deliver GM materials for analysis.

Supporting documentation:

Domingo, J. L. (2000). Health Risks of GM Foods: Many Opinions but Few Data. Science 288, 1748-1749.

Ewen, S. W. B. & Pusztai, A. (1999). Effect of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. Lancet 354, 1353-1354.

Fares, N. H. & El-Sayed, A. K. (1998). Fine Structural Changes in the Ileum of Mice Fed on d Endotoxin-Treated Potatoes and Transgenic Potatoes. Nat. Toxins 6, 219-233.

Freese, W. & Schubert, D. (2004). Safety testing and regulation of genetically engineered foods. Biotechnol. Genet. Eng. Rev. 21, 299-324.

Mayer, S. & Stirling, A. (2004). GM crops: good or bad? EMBO Rep. 5, 1021.

Pryme, I. F. & Lembcke, R. (2003). In vivo studies on possible health consequences of genetically modified food and feed—with particular regard to ingredients consisting of genetically modified plant materials. Nutr Health 17, 1-8.

Pusztai, A. (2002). Can science give us the tools for recognizing possible public health risks for GM food?. Nutr Health 16.

2.  With reference to this sentence:  " ........ it should also be recognised that EFSA's opinions on GMOs are not restricted to the provided data alone, such as applicant dossiers, but also takes into account studies carried out by independent researchers and published in peer review scientific journals."  We are intrigued by the fact that the EFSA  GMO Panel does in theory take into account "independent" studies which may be brought to its attention in the assessment of GMO varieties, but it tends to be dismissive of independent studies critical of GMOs that may not appear in peer- reviewed journals, while being perfectly prepared to accept non-assessed and highly selective and manipulated research from the companies assembling their GM application dossiers. The approach of EFSA is far from being even-handed; it applies a high level of scepticism when considering independent research, and a high level of acceptance when considering industry-led research (Mueller, 2008). This is one of the reasons why EFSA is so mistrusted by NGOs and consumer groups.  On a related matter, EFSA appears quite unconcerned about the fact that much of the research reported upon in applicant dossiers is NON-REPLICABLE for the simple reason that the GM patent holders / applicants simply refuse, as a matter of course, to allow their GM plant materials, seeds or reference materials to be used for independent analysis. Since non-replicable science should never be accepted as valid by any reputable scientific committee, we have made the point repeatedly to EFSA that no dossier material should be taken at face value unless it is accompanied by a statement from the applicant specifically committing to the provision of requested GM materials for independent repeat experiments or follow-up studies.  In the absence of such cooperation by applicants, it should be assumed that their studies are fraudulent.  EFSA has refused to address this issue, and the Commission reply to our petition also omits to mention it.  That is simply not acceptable, and we insist that as a result of this connivance in poor or fraudulent research, the health of EU consumers is being put at risk. In 2005, at a  GM meeting at FOA headquarters in Rome, Dr Harry Kuiper, chair of the GMO panel of EFSA, stood against the consensus among the 12 invited scientist and refused to consider independent feeding studies as a means of settling the rising controversy over the safety of GM foods.  That neatly summarises EFSA's real position.

Supporting documentation:

Mueller, W. (2008) EFSA misleads the European Commission and the public over GMOs
Eco-risk, Vienna, May 2008, 4 pp.

Pollack, A.  (2009).  Crop scientists say biotechnology seed companies are thwarting research.  New York Times. CheckBiotech,
Friday, February 20, 2009

GM Free Cymru (2007)  PERVERTED SCIENCE -- THE MANIPULATION OF GM RESEARCH.   How "inconvenient" GM research is stifled, starved, marginalized and patronized.

Fatka, J.  (2009) Biotech companies limiting independent GM analysis.  Farm  Weekly, 16 March 2009

3.  With reference to this statement:  "Directive 2001/18/EC and Regulation (EC) No 1829/2003 both provide for a public access to the information and data received during the authorisation process and offer the public the possibility to forward comments to the Commission further to the risk assessment and before the adoption of the authorisation decision."  This is fine in theory, but in practice EFSA puts major obstacles in the way of those who wish to peruse full dossiers or even selected parts of a dossier.  It misuses "commercial in confidence" rules to prohibit or restrict access to documents.  For example, in the case of MON863 EFSA hid important research information just because Monsanto asked it to, until it was forced by a German court ruling to accept that the public interest and the "right to know" must override the commercial interests of a seed owner. When independent analysis of the MON863 data showed up serious statistical flaws and possible data manipulation, EFSA refused to revise its good opinion of MON863, preferring instead to criticise the independent researchers for perceived flaws in their work. In 2006, in the case of LLRice601, EFSA withheld 30 pages of diagrams and data from perusal, simply because Bayer asked it to, and with no sound scientific or economic justification.  It has a track record of protecting the interests of commercial GMO developers and blocking truly independent analysis of data and full public access.

Supporting documentation:

Greenpeace (2005) Preliminary report by Criigen on the “First public investigation of the crude data in Mon 863 toxicity tests on

GeneWatch (2005) Response of GeneWatch UK to questionnaire for Member States on the implementation of Regulation (EC) 1829/2003 of the European Parliament and of the Council on genetically modified food and feed.  (February 2005)

Ho, Mae-wan.  (2007) French scientists find signs of toxicity to liver and kidney in Monsanto’s study on its controversial GM maize. ISIS Report 03/05/07.  GM Maize MON 863 Toxic.

Séralini G-E, Cellier D, Spiroux de Vendomois J. (2007) New analysis of a rat feeding study with genetically modified maize reveals signs of hepatorenal toxicity. Arch Environmental Contamination and Toxicology 2007, published online 13 March 2007.

Séralini G-E, Cellier D, Spiroux de Vendomois J. Crii-Gen Letter to EFSA, 20 April 2007,
       Bt maize MON863: EFSA stands by its opinion: No concerns.  GMO Safety (2007)

John, B.S. (2006) OPEN LETTER:  Protest re EFSA's refusal of full disclosure of information on LLRICE601. 16th September 2006

Smith, J.M.  (2005) Cause For Concern.  The Ecologist, October 2005.

Thus there are very substantial reasons why this Petition should be "kept open" for further detailed consideration -- and I will provide further evidence relating to my concerns if the Committee wishes