GM Free Cymru

Pressure mounts on EC over "perverse science" used for GM approvals

PRESS NOTICE 10th February 2012

Over the past few weeks pressure has been mounting on the European Commission over its perverse and sinister interpretation of science and the scientific method.

With the encouragement of the GM industry, the EC continues to argue that in the reassessment of the rules controlling the cultivation of GM crops in Europe, national bans or restrictions may be based on environmental, regional or socio-economic considerations, but not on scientific grounds. This erratic and illogical view is based on the thesis that if a crop is considered as safe for health and the environment by EFSA, and is then approved on that basis, further scientific debate becomes irrelevant since the matter is settled (1).

Many NGOs, and indeed member states, have pointed out that this use of EFSA's GMO panel as "the final arbiter" in the scientific issues related to GM crops and foods is both irrational and dangerous, since it is based upon a profound misunderstanding of how science works (2). Scientific experimentation and development cannot be contained or directed in this way, and EFSA and the Commission have shown themselves, over and again, to be unprepared to consider independent research into the effects of GMOs on health and the environment as "valid"-- and even when they have been forced to take 'inconvenient" research findings into account, they have subjected them to hostile scrutiny quite unlike that which is applied to the science contained within GMO applicants' research dossiers (3). We are not aware of a single case where an EFSA opinion relating to a GM variety has been varied or changed following the publication of damning independent research findings. It appears that EFSA's self-esteem is a more important consideration than public safety.

Furthermore, both EFSA and the Commission have sought on many occasions to portray the use of the "safeguard clause" by member states in support of national GM bans as being politically motivated, whereas in the majority of cases those states have had genuine concerns about GM safety based on new scientific information in the peer reviewed literature. Over and again, EFSA has assessed this "new" information and has declared that it is inadequate to trigger any variation in the advice already issued by the GMO Panel -- even though that original advice may be more than a decade old and may have been based upon faulty science. Consequently, in the eyes of some member states, EFSA and the Commission are seen as using science as a political tool for the promotion of a pro-GM political agenda (4).

For years the reliability of EFSA's science has been questioned by NGOs and consumer groups, on the basis that its GMO Panel has strong and unhealthy links (and revolving doors) with the GM industry (5), that its operations are secretive and biased, and that its undeclared priority is to facilitate GMO consents rather than to protect the health of the people of Europe. Furthermore, it has from the beginning based its assessments of GMO varieties on assumptions and concepts which are scientifically nonsensical -- for example the "concept of substantial equivalence" and the "concept of familiarity." (6) EFSA has never properly assessed the indirect effects of GMO plant cultivation or use, particularly with respect to herbicide residues, preferring instead to concentrate on the narrowest possible interpretation of "direct effects" related to the process of genetic modification. Thus there is nothing approaching a holistic assessment of total health and environmental impacts. This is the cause of profound disquiet among member states and NGOs (7).

In addition, EFSA seems to many observers to be in a state of denial relating to scientific disagreements, and it has never properly fulfilled the requirement placed upon it in the Directives to fully document the scientific uncertainties that exist when opinions and advice (concerning GM plant varieties) are issued to the Commission and the member states. It appears to many observers that EFSA seeks to maintain its status within the EU through peddling a myth of "scientific certainty" -- and through a process of dismissing or belittling any scientific research which it finds inconvenient. Because the Commissioners are not themselves scientists, they find it convenient politically to accept this perverse myth of what science is, and how it works.

In a recent highly critical assessment of the operation of science in the area of GM risk assessments, Wickson and Wynne say this (4): "Disputed science is crucial in disagreements over GMOs, but the dispute is not limited to facts revealed by research. It is also about the normative commitments that scientists make and how these shape what are deemed to be salient and reliable facts; for example, the choices made concerning the relevant questions to ask, the appropriate methods to employ, the pertinent baselines for comparison and so on. The EC’s proposal embodies a confusion of risk science with an idealized model of pure scientific research unaffected by normative considerations, and which, therefore, supposedly speaks only in the singular voice of Nature. Thus the EC produces a framework that asserts that current scientific and regulatory institutions, namely the EFSA in this case, are sufficiently capable of exhaustively defining and assessing such risks in an impartial, objective and over-arching way. However, not only are there legitimate scientific differences in environmental, agronomic and health risk assessment situations across Europe, there are also unacknowledged social, ethical and political commitments embedded in the supposedly singular EC risk science. An unavoidable effect of this confusion is that member states’ legitimate differences with EFSA’s ‘science’ (which stands for EC–EU policy), are arbitrarily rendered ‘unscientific’ and illegitimate."

Speaking for GM-Free Cymru, Dr Brian John (who currently has two Petitions before the EU Petitions Committee relating to EFSA's failure to adequately protect the public) said: "It is increasingly clear that the scientific model which both EFSA and the EC are intent upon maintaining is neither value-free nor objective, and on that basis it is untrustworthy and unsustainable. EFSA's brand of GM science is driven by political motives and by a desire to maintain total control of the scientific agenda, and unless that situation changes dramatically there will continue to be profound mistrust of EFSA's own scientists and also a lack of respect for science itself. EFSA has been asked over and again to put its house in order, but it has failed to do that. Its GMO Panel makes perverse decisions. It is not fit for purpose, and it should be disbanded and then reconstituted with a brand new set of guidelines. At the same time, the Commission must fundamentally reconsider the role of science in the decision making process for GM crops and foods." (8)

ENDS Contact: Dr Brian John for GM-Free Cymru Tel 01239-820470

NOTES

(1) An EFSA "opinion" declaring a GM variety safe may be quite worthless scientifically. EFSA hardly ever identifies scientific fraud, effectively leaving that task to others who have the persistence and the expertise to apply close scrutiny (under very difficult conditions) 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 routinely accepted in which "surrogate proteins" 9rather than the actual proteins expressed in GM plants) have been used in toxicology studies; health and safety 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. The GMO Panel 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 would like to see something on the Norwegian model -- in which "societal benefit" has to be assessed before any GM consent is issued. 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.

(2) MEPs heard serious questions raised about EFSA's impartiality in taking decisions in respect of authorising GMOs, with key concerns including: EFSA's use of confidential, untested data provided by the applicants in making its decisions; the pro-industry bias of EFSA's decisions panel with a majority drawn from GM industry backgrounds; a lack of independent scientific testing of plants prior to authorisation decisions; a lack of transparency and public access to the decision making process; inflexibility in decision making and a refusal to review decisions over time. EU food safety agency future questioned Plaid Cymru The Party of Wales in the European Parliament PRESS RELEASE Jill Evans MEP

(3) For example, after a detailed analysis of many of the portions of the dossier on MON87705 submitted to EFSA by Monsanto, GENOK in Norway identified a number of methodological and conceptual weaknesses contained in the research, including: improper assumptions; weakness in study design and/or methodology that bias against the detection of differences; lack information on potential relevant adverse effects; and improper use of comparators. Assessment of the technical dossier related to EFSA/GMO/NL/2010/78 Submitted to Direktoratet for Naturforvaltning by Centre for Biosafety – GenØk and Center for Integrated Research in Biosafety September 2010 Authors: Prof. Jack Heinemann Dr. Brigitta Kurenbach Dr. David Quist PDF available here:

http://www.genok.com/news_cms/2010/october/genØk_s_assessment_of_
genetically_modified_soybean_mon87705/117

(4) Fern Wickson & Brian Wynne, "The anglerfish deception", EMBO Report, Science and Society, 6pp.

(5) http://www.gmfreecymru.org/documents/new_study.html Europe’s pesticide and food safety regulators – Who do they work for? by Claire Robinson Contact: clairejr@sky.com Earth Open Source 2011 http://www.powerbase.info/index.php/File:Eu_pesticidefoodsafety.pdf The issue of conflicts of interest and revolving doors have still not been adequately addressed. http://www.testbiotech.de/en/node/591 European Ombudsman demands EFSA admit failure http://www.corporateeurope.org/sites/default/files/2011-02-23_MB_REPORT http://www.testbiotech.de/en/node/431

(6) The GMO Emperor has no clothes. (A Global Citizens Report on th state of GMOs -- false promises, failed technologies. Synthesis Report, 58 pp. "Substantial equivalence is a pseudoscientific concept because it is a commercial and political judgment masquerading as if it were scientific. It is, moreover, inherently antiscientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit potentially informative scientific research". (E. Millstone, E. Brunner and S. Mayer, Nature, October 1999)

(7) http://www.gmfreecymru.org/news/Press_Notice09aNov2011.htm
http://www.testbiotech.de/en/node/595 Database on the risks of genetically engineered crop plants Testbiotech offers overview of EU authorisations, 15. December 2011
http://www.gmfreecymru.org/open_letters/Open_letter29Nov2011.html
http://www.gmfreeze.org/publications/briefings/125/
http://www.gmfreeze.org/legal-news/ecs-gm-cultivation-proposals-riddled-legal-uncertainty-and-lack-/ http://www.foeeurope.org/press/2011/Feb7_EU_to_vote_new_GMO_contamination_rules.html http://www.gmfreecymru.org/news/Press_Notice04bJunel2010.htm

(8) http://www.gmfreecymru.org/petition.html
http://www.gmfreecymru.org/open_letters/Open_letter23Feb2010.html