.

DOCUMENTED HARMS OF GENETICALLY ENGINEERED CROPS AND FOODS

NEW EVIDENCE OF HARM FROM GM FOOD TRIGGERS CALL FOR IMMEDIATE BAN

Press Notice 25th November 2005
Immediate Release
Source: GM Free Cymru, Wales, UK (1)
( Abbreviated synopsis)

New studies of the health effects of GM foods have triggered
fresh demands for GM components in human food and animal feed to be banned immediately, and have also led to accusations of criminal
negligence aimed at the UK Government and European Commission.

A study conducted by Manuela Malatesta and
colleagues in the Universities of Pavia and Urbino in Italy, showed that mice fed on GM soya experienced a slowdown in cellular metabolism and modifications to liver and pancreas (2). A second study, conducted by CSIRO in Australia, showed that the introduction of genes from a bean variety into a GM pea led to the creation of a novelprotein which caused inflammation of the lung tissue of mice (3). So serious was the damage that the research was halted, and stocks of the GM pea have been destroyed. The developers have now made a commitment that the "rogue" variety will never be marketed.

These studies, all revealed in the scientific literature within the
past few weeks, have caused widespread alarm throughout the world, since one of them suggests that GM soya (used in a large number of foods) might be very dangerous, and since they appear to confirm the findings of Dr Arpad Pusztai and Dr Stanley Ewen, whose paper on physiological changes in rats fed on GM potatoes caused a worldwide sensation in 1999 (4). The authors were given the full "shoot the messenger" treatment; they were widely vilified by the scientific community, and following an intervention from the office of Prime Minister Tony Blair Dr Pusztai was sacked, his research team was dismantled, and his funding stopped. The Ewen/Pusztai research has never been repeated, let alone extended, for fear that their results will also be replicated. And there has never been a comprehensive human feeding trial involving GM food.

There is now overwhelming evidence in the literature of deaths
attributable to GM products -- among laboratory and farm animals and in the human population. Some of this evidence is presented below. Despite opposition from European Member States, the European Commission appears to be intent upon issuing one contentious and dangerous GM authorization after another, and basing its decisions upon highly selective and biased research by the applicants themselves, while taking guidance from a despised European Food Safety Authority which has lost the confidence of NGOs and consumer groups across Europe.

Speaking for GM Free Cymru, Dr Brian John said today: "Neither the UK government nor the European Commission can pretend any longer that GM foods are harmless. They must stop singing from the hymn-sheets provided for them by the GM industry, and -- not before time --recognize that they have a legal duty to protect residents and
consumers. In our view they are already guilty of criminal negligence
and the willful suppression of facts. There must be no further GM
consents, and GM foodstuffs must be banned immediately -- at least
until such time that independent research on animals and humans gives GM a clean bill of health (24). We already know enough to be confident that that will never happen (25)."

Professor Malcolm Hooper (20) said: "The genetic modification to food is not without danger to the consumer who may be affected by genetic changes that subsequently lead to serious chronic illnesses (cancer and chronic inflammatory disease). Further independent studies, divorced from any influence of government or corporations, are now imperative and urgent."

Prof Vyvyan Howard (21) said: "We need to change the focus of the
debate away from the limited studies that have been done to date onto the size of the irreversible legacy that we are probably going to leave for future generations".


=============================

BRIEFING NOTE

OTHER EVIDENCE OF HARM

In spite of concerted efforts from the GM industry and from the
political establishment to prevent truly independent research on the
health effects of GM food, there is now a mass of information in the
public domain to demonstrate that such food is potentially dangerous.
We will never know how many GM varieties have been developed and then quietly abandoned before reaching the regulatory process as a result of deaths or physiological damage during animal feeding trials, since studies by Monsanto, Syngenta and the other GM corporations are conducted in-house and under conditions of great secrecy. But we do know of at least seven cases where GM varieties have been withdrawn because of direct evidence of health damage (5) (6) (7); and there are many instances of human and animal deaths arising from GM feeding trials and premature release onto the market of GM products (8-12).  In the most deadly case of all, the premature release of the GM food supplement L-tryptophan in the USA led to a large number of human deaths (estimates range from 39 to well over 100) and to the development of a new disease (referred to as eosinophilia myalgia syndrome, or EMS) which afflicted up to 10,000 people (8). When StarLink maize (intended and only approved for animal fodder) found its way into the US human food chain in 2000, there was a massive food scare when it was realized that it was potentially capable of triggering severe allergic reactions; the crop was recalled (far too late), and $9 million had to be paid out in compensation (6). People may well have died, but the medical impact of the Starlink fiasco is a closely-guarded secret. In Hesse, Germany, 12 dairy cows died in 2001-2002 after eating GM fodder maize Bt176, which contains the Cry1Ab protein (11). When broiler chickens were fed on a diet of Chardon LL (T25) maize, the mortality rate was twice as high as that of the control group. That fodder maize variety has now been withdrawn. When the infamous Flavr-Savr GM tomato was tested, 7 out of 40 rats died within two weeks due to necrosis (5). In the case of the GM bovine growth hormone known as rBGH or BST Monsanto has persistently attempted to promote its use in spite of abundant evidence of cattle deaths and attributable problems including mastitis (10). Allergic reactions among farm workers have been preliminarily linked to Monsanto Bt maize
and Bt cotton in the Philippines (2004) and India (2005), respectively
(14).

In 2005 Monsanto was heavily criticized across the world for the
obsessive secrecy with which it sought to keep animal feeding studies for MON863 maize out of the public domain (6). The company even insisted on a "gagging order" on Dr Arpad Pusztai, the scientist retained by the German Government to assess the scientific dossier submitted with the Monsanto authorization application to the EU. The study found "statistically significant" differences to kidney weights and certain blood parameters in the rats fed on the GM maize as compared with the control groups, and a number of scientists across Europe who saw the study (and heavily-censored summaries of it) expressed concerns about the health and safety implications if MON863 should ever enter the food chain. There was particular concern in France, where Prof Gilles-Eric Seralini of the University of Caen had been trying (without success) for almost eighteen months to obtain full disclosure of all documents relating to the MON863 study. At last, it required a resolute campaign from NGOs and a German court order to obtain the release of the study, which was then revealed to have been highly selective, and carefully designed to minimize negative health effects.
There have still been virtually no studies of the impact of GM food
consumption on human health. But in one small study, referred to as
the "Newcastle Feeding Study", showed in 2003 that even after one small meal containing a GM soya component, transgenes could transfer out of GM food into gut bacteria at detectable levels (15). The study was commissioned by the FSA in the UK, and that body (which has consistently promoted the merits of GM food) was so frightened by the implications of the result that it has refused absolutely to commission any repeat or follow-up studies in spite of a flood of requests from NGOs and consumer groups.

A CONSPIRACY OF FALSEHOOD
During the past decade, as the giant biotechnology corporations have extended their power base and have taken over the role as the prime funders of GM research, politicians worldwide have been happy to promote the merits of biotechnology and to believe almost everything fed to them by the spin-doctors of Monsanto, Syngenta and other companies. They have blindly promoted the interests of these corporations in spite of on-going and vociferous opposition from the public -- and from concerned NGOs and consumer groups. Public opinion polls consistently show large majorities in Europe who are opposed to the use of GMOs in food supplies. Independent scientists who have had the temerity to question the objectivity of studies submitted with applications for GM approvals, or who have themselves published "uncomfortable" research, have been victimized, marginalized and "warned off" further involvement with community groups. The conclusion is inescapable that the British Government, and the EC, subscribe to a corrupt scientific system which is based upon the following contract: "we tell you in advance what the result is, and you will be paid to get on with your work and provide us with the evidence we need". For at least ten years the industry has consistently peddled the line that nobody has ever died or even been harmed as a result of consuming GM products. That is a lie, and it is still a lie if it is repeated a thousand times. These are typical reproductions of the lie:

Eliott Morley, Environment Minister: "In terms of existing products
there has never been any indication that there is a health risk."
Dr Christopher Preston: "Many studies have been published since 2002 and all have reported no negative impact of feeding GM feed to the test species."
http://www.agbioworld.org/biotech-info/articles/biotech-art/peer-
reviewed-pubs.html
CSIRO plant industry deputy director T. J. Higgins: "People have been eating GM food for 10 years and there isn't a single piece of evidence that it's any less safe than conventional food."

SIGNS OF PANIC
There are signs that the new studies of damage inflicted by GM
foodstuffs is spreading panic in the corridors of power. That is why
representatives of the President of the EC rang up Manuela Malatesta and her colleagues in Italy. That is why there is growing mistrust between the European Parliament and EFSA, which has a long reputation for "facilitating GM approvals" instead of protecting the European public. That is why EFSA has been forced to hold a stakeholders meeting (17) and to accept a barrage of criticism from NGOs and consumer groups furious with its secrecy, its complacency and its easy acceptance of all the evidence placed before it by Monsanto and other GM corporations (18). That is why the FAO organized an invitation-only workshop in its Rome HQ in October 2005 with 12 invited scientists, in order to assess the likelihood of health damage in the general population arising from the spread of GM foods. Dr Stanley Ewen, a practicing consultant histopathologist at Grampian University Hospital Trust, was invited to give the opening presentation. He subsequently said: " We laid down a definitive protocol for the testing of GM food using animals and, indeed, humans. However, Dr Harry Kuiper of the European Food Safety Authority made it quite clear that his organisation was content to accept the results of "objective studies" carried out by the GM companies. I am concerned that such objective studies are still only being developed. Additionally, that the EFSA will only commission animal experiments if there were serious molecular differences between the parent protein and the genetically modified protein. Then there would seem to be the question of who would fund such experiments and where would they be carried out? I firmly believe that there continues to be an urgent need for independent animal and human testing."

We understand from others present at that meeting that there was a
consensus that there are many gaps in scientific knowledge,
particularly related to GM health risks, and that new work on such
risks must be commissioned at the earliest opportunity; but that Dr
Kuiper, on behalf of EFSA, effectively refused to sanction such new
work and refused to commit funding to it. As far as he is concerned,
he is blind to any ill-effects arising from the consumption of GM
foods, and he is also content to continue leading the blind European
Commissioners who foolishly depend on him for guidance.

COMMENTS
Responding to the three new GM studies, and to the avalanche of new work demonstrating that GM foods are actually harmful to human beings and other animals, Dr Michael Antoniou (22) said: "If the kind of detrimental effects seen in animals fed GM food were observed in a clinical setting, the use of the product would have been halted and
further research instigated to determine the cause and find possible
solutions. However, what we find repeatedly in the case of GM food is
that both governments and industry plough on ahead with the
development, endorsement and marketing GM foods despite the warnings of potential ill health from animal feeding studies, as if nothing has happened. This is to the point where governments and industry even seem to ignore the results of their own research! There is clearly a need more than ever before for independent research into the potential ill effects of GM food including most importantly extensive animal and human feeding trials." (24)

Speaking for GM Free Cymru, Dr Brian John said: "With news of these three studies, we have come to the inescapable conclusion that there is something seriously wrong with GM food. Any averagely intelligent person must also come to that conclusion. We think that GM soya is particularly dangerous. The GM industry, the regulatory authorities in Britain and Europe, and the politicians who are supposed to look after us, have been living in a permanent state of denial about GM ever since Arpad Pusztai and Stanley Ewen published their Lancet paper in 1999. If they persist in the pretence that all is well in the GM garden for a moment longer, they will compound their criminal negligence and their willful suppression of facts (23). They have already lost the trust of the present generation of consumers; if they continue to treat the protection of biotechnology multinationals as a greater priority than the protection of consumer health they will be guilty of a deliberate and cynical betrayal of the interests of future generations. We want nothing less than an immediate ban on all GM crops, all GM food and all GM animal feed."


NOTES AND REFERENCES

1. Report prepared by Dr. Brian John, GM Free Cymru. Tel 01239-820470

2. Manuela Malatesta and her colleagues have published five papers
2002-2004.
http://www.greenplanet.net/Articolo9833.html&prev=/search?
q=Manuela+Malatesta&hl=en&lr=&ie=UTF-8&sa=G)
Mangiare OGM non fa differenza? Non proprio.......
Abstracts of the papers can be found here:
http://www.agbioworld.org/biotech-info/articles/agbio-articles/
GMfeedsafetypapers.html

3. Study conducted by the Commonwealth Scientific and Industrial
Research Organisation.
http://pubs.acs.org/cgi-bin/abstract.cgi/jafcau/2005/53/i23/abs/
jf050594v.html
New Scientist article:
http://www.newscientist.com/article.ns?id=dn8347

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

5. The Flavr-Savr tomato was withdrawn in 1996, amid claims that it
was a commercial failure. So was another variety called Endless
Summer. But trials of the Flavr-Savr tomato showed there were health
concerns which contributed to the "commercial" decision.
http://www.soilassociation.org/web/sa/saweb.nsf/0/
80256cad0046ee0c80256d1f005b0ce5?OpenDocument

6. The StarLink maize fiasco occurred in 2000and is well documented.
See also:
http://www.i-sis.org.uk/biotechdebacle_updated.php

7. A new GM soya was developed, containing genes from Brazil nuts
(1996). A novel protein was accidentally created which had the
potential to affect people with nut allergies -- so the GM soya was
withdrawn:
http://www.health24.com/dietnfood/Food_causing_disease/15-737
-740,32410.asp

8. As a consequence of the L-tryptophan scandal (1989) there were  100 deaths (Jeffrey Smith). See these:
>http://www.responsibletechnology.org/utility/showArticle/?
objectID=283&find=L%2Dtryptophan
www.seedsofdeception.com/Public/L-tryptophan/index.cfm

9. Fares NH, El-Sayed AK. 1998. Fine structural changes in the ileum
of mice fed on delta-endotoxin-treated potatoes and transgenic
potatoes. Nat Toxins. 6:219-33.

10. The rBGH bovine growth hormone (BST) has been promoted globally by Monsanto in the full knowledge of science showing damage to both cattle and those who consume the milk of cows treated with rBGH.
http://www.responsibletechnology.org/utility/showArticle/?
ObjectID=193&find=BST

11. The deaths of cattle in Hesse, Germany, have been linked with
Bt176 maize, but there appear to have been determined efforts to "lose" key scientific information and to attribute the cattle deaths to
mismanagement and other factors.
http://www.i-sis.org.uk/CAGMMAD.php

12. Broiler chickens fed on Chardon LL -- the mortality rate was twice
as high as that of the control group (NB the infamous case of Prof Alan Gray of ACRE and the failure of that Committee to examine evidence placed before it........)
http://www.i-sis.org.uk/appeal.php

13. Rats fed on Chardon LL -- weight gain was much reduced
http://www.i-sis.org.uk/appeal.php

14. The work of the Norwegian scientist Terje Traavik and his colleagues is on-going and has still to be published. But see:
"Filipino islanders blame GM crop for mystery sickness. Monsanto denies scientist's claim that maize may have caused 100 villagers to fall ill"
-- John Aglionby in Kalyong, southern Philippines, The Guardian,
Wednesday 3 March 3, 2004
http://www.guardian.co.uk/gmdebate/Story/0,2763,1160789,00.html
Allergic reactions and livestock deaths 2005 attributable to Bt cotton In India (Madhya Pradesh):
http://news.webindia123.com/news/showdetails.asp?id=170692&cat=Health

15. The Newcastle feeding study (published 2003) involved a small
portion of GM soya fed to just seven ileostomy patients:
http://www.foodstandards.gov.uk/news/newsarchive/statement
http://www.gmwatch.org/archive2.asp?arcid=990

Comments by Dr Michael Antoniou
http://www.gmwatch.org/print-archive2.asp?arcid=143

16. Re the Monsanto rat feeding study on MON863 maize, which the
company was desperate to keep out of the public domain (2004):
http://www.seedsofdeception.com/utility/showArticle/?objectID=221
Genetically Modified Corn Study Reveals Health Damage and Cover-up, by Jeffrey M. Smith
http://news.independent.co.uk/world/science_technology/story.jsp?
story=640430
http://www.efsa.eu.int/science/gmo/gmo_opinions/381_en.html
http://www.gmwatch.org/archive2.asp?arcid=5270

17. See this for the Stakeholders Meeting:
http://www.gmwatch.org/archive2.asp?arcid=5804

18. See, for example:
ttp://eu.greenpeace.org/downloads/gmo/Bt11reportOct05.pdf

19. Workshop on Safety of Genetically Modified Foods held at FAO
Headquarters, Rome, 13 - 14 October
ftp://ftp.fao.org/es/esn/food/meetings/2005/gm_workshop_info.pdf

20. Emeritus Professor of Medicinal Chemistry,
School of Sciences, University of Sunderland, UK

21. Professor of Bioimaging, School of Biomedical Sciences
University of Ulster, Coleraine campus

22. Reader in Medical and Molecular Genetics, King's College London

23. The regulatory system for GM crops and foodstuffs is a disgrace,
and needs to be scrapped and replaced. The GM authorizations process in both Europe and the USA is underpinned by the scientifically nonsensical concept of "substantial equivalence", by which a cow with BSE would be considered to be "substantially equivalent" to onewithout. Further, the authorities depend almost exclusively upon the "science" submitted by the biotechnology corporations with their applications, which is almost always partial and selective. In other words, it is corrupt. Again, the regulatory process is designed - quite specifically - to facilitate authorizations rather than to protect the consumer. The regulatory bodies themselves are packed with placements from the GM industry -- people whose very careers depend upon a continuation of the GM enterprise. The precautionary principle, which is supposed to underpin the regulatory process, has now been effectively replaced by the "anti-precautionary principle", by which GMs are assumed to be harmless unless opponents can prove otherwise, on a variety-specific basis. But independent scientists cannot undertake
effective research because the genetic constructs of new GM varieties are closely guarded secrets, and because governments will not fund their studies. And finally, in Europe at least, the Commission is more concerned about politics than science, and is determined to issue GM authorizations, come hell or high water, just to show the Americans and the WTO that there is no GM moratorium in place.

24. Letters have now gone from GM Free Cymru to the UK Food Standards Agency and to the European Food Safety Authority demanding the initiation of an urgent programme of independent research into the health effects of GM food, on the lines discussed at the recent unpublicised FOA meeting in Rome. Copies of these letters are available on request.

25. According to a letter received 24.11.05 from Arpad Pusztai, "A
consistent feature of all the studies done, published or unpublished,
including MON863, indicates major problems with changes in the immune status of animals fed on various GM crops/foods, the latest example of this coming from the GM pea research in Australia."

It should also be added that recent studies have shown that the pollen from various types of Bt corn/maize will kill caterpillars and other insects when the wind-blown pollen settles on the leaves of other plants; and that both Bt corn and Bt cotton crop residues contaminate the soil with Bt toxin.

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Jeffrey M. Smith, who publishes Spilling The Beans, a monthly column available at www.responsibletechnology.org. writes that:
It turns out that the damage done to DNA due to the process of creating a genetically modified organism is far more extensive than previously thought.[1] GM crops routinely create unintended proteins, alter existing protein levels or even change the components and shape of the protein that is created by the inserted gene. The concerns of Kirk Azevedo, former Monsanto employee and whistle blower (who left the company after his concerns about their GM crop varieties producing harmful mis- folded proteins, which he felt were in some ways analogous to the mis-folded prions responsible for Mad Cow disease, fell on deaf ears), have been echoed by other scientists as one of many possible dangers that are not being evaluated by the biotech industry’s superficial safety assessments.

GM cotton has provided ample reports of unpredicted side-effects. In April 2006, more than 70 Indian shepherds reported that 25% of their herds died within 5-7 days of continuous grazing on Bt cotton plants.[2] Hundreds of Indian agricultural laborers reported allergic reactions from Bt cotton. Some cotton harvesters have been hospitalized and many laborers in cotton gin factories take antihistamines each day before work.[3]

The cotton's agronomic performance is also erratic. When Monsanto's GM cotton varieties were first introduced in the US, tens of thousands of acres suffered deformed roots and other unexpected problems. Monsanto paid out millions in settlements.[4] When Bt cotton was tested in Indonesia, widespread pest infestation and drought damage forced withdrawal of the crop, despite the fact
that Monsanto had been bribing at least 140 individuals for years, trying to gain approval.[5] In India, inconsistent performance has resulted in more than $80 million dollars in losses in each of two states.[6] Thousands of indebted Bt cotton farmers have committed suicide. In Vidarbha, in north east Maharashtra, from June through August 2006, farmers committed suicide at a rate of about one
every eight hours.[7] (The list of adverse reactions reported from other GM crops, in lab animals, livestock and humans, is considerably longer.)

Kirk's concern about GM crop test plots also continues to remain valid. The industry has been consistently inept at controlling the spread of unapproved varieties. On August 18, 2006, for example, the USDA announced that unapproved GM long grain rice, which was last field tested by Bayer CropScience in 2001, had contaminated the US rice crop[8] (probably for the past 5 years). Japan
responded by suspending long grain rice imports and the EU will now only accept shipments that are tested and certified GM-free. Similarly, in March 2005, the US government admitted that an unapproved corn variety had escaped from Syngenta’s field trials four years earlier and had contaminated US corn.[9] By year's end, Japan had rejected at least 14 shipments containing the illegal
corn. Other field trialed crops have been mixed with commercial varieties, consumed by farmers, stolen, even given away by government agencies and universities who had accidentally mixed seed varieties.

Some contamination from field trials may last for centuries. That may be the fate of a variety of unapproved Roundup Ready grass which, according to reports made public in August 2006, had escaped into the wild from an Oregon test plot years earlier. Pollen had crossed with other varieties and wind had dispersed seeds. Scientists believe that the variety will cross pollinate with other grass varieties and may contaminate the commercial grass seed supply—70 percent of
which is grown in Oregon.

Even GM crops with known poisons are being grown outdoors without adequate safeguards for health and the environment. A corn engineered to produce pharmaceutical medicines, for example, contaminated corn and soybean fields in Iowa and Nebraska in 2002.[10] On August 10, 2006, a federal judge ruled that the drug-producing GM crops grown in Hawaii violated both the Endangered Species Act and the National Environmental Policy Act.[11]

A December 29, 2005 report by the USDA office of Inspector General, blasted the agriculture department for its abysmal oversight of GM field trials, particularly for the high risk drug producing crops.[12] And a January 2004 report by the National Research Council also called upon the government to strengthen its oversight, but acknowledged that there is no way to guarantee that field trialed crops will not pollute the environment.[13]

With the US government failing to prevent GM contamination, and with state governments and agriculture commissioners unwilling to challenge the dictates of the biotech industry, some California counties decided to enact regulations of their own. California’s diverse agriculture is particularly vulnerable and thousands of field trials on not-yet-approved GM crops have already taken place
there. If contamination were discovered, it could easily devastate an industry.  Four counties have enacted moratoria or bans on the planting of GM crops, including both approved and unapproved varieties. This follows the actions of more than 4500 jurisdictions in Europe and dozens of nations, states and regions on all continents, which have sought to restrict planting of GM crops to protect their health, environment and agriculture.


{Jeffrey Smith's forthcoming book, Genetic Roulette, documents more than 60 health risks of GM foods in easy-to-read two-page spreads, and demonstrates how current safety assessments are not competent to protect consumers from the dangers. His previous book, Seeds of Deception (www.seedsofdeception.com), is
the world's best selling book on the subject. Spilling the Beans is a monthly column available at www.responsibletechnology.org.)

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[1] JR Latham et al., "The Mutational Consequences of Plant Transformation," The Journal of Biomedicine and Biotechnology, Vol 2006 Article ID 25376 Pages 1-7, DOI 10.1155/JBB/2006/25376; for a more in-depth discussion, see also Allison Wilson et al., "Genome Scrambling -Myth or Reality? Transformation-Induced Mutations in Transgenic Crop Plants, Technical Report - October 2004,
www.econexus.info.

[2] Mortality in Sheep Flocks after Grazing on Bt Cotton Fields – Warangal District, Andhra Pradesh. Report of the Preliminary Assessment April 2006,
http://www.gmwatch.org/archive2.asp?arcid=6494

[3] Ashish Gupta, et. al., Impact of Bt Cotton on Farmers’ Health (in Barwani and Dhar District of Madhya Pradesh), Investigation Report, Oct - Dec 2005

[4] See for example, Monsanto Cited In Crop Losses New York Times, June 16, 1998, http://query.nytimes.com/gst/fullpage.html?res=9A04EED6153DF935A25755C0A96E958260;
and Greenpeace http://archive.greenpeace.org/geneng/reports/gmo/intrgmo5.htm

[5] Antje Lorch, Monsanto Bribes in Indonesia, Monsanto Fined For Bribing Indonesian Officials to Avoid Environmental Studies for Bt Cotton, ifrik 1sep2005, http://www.mindfully.org/GE/2005/Monsanto-Bribes-Indonesia1sep05.htm

[6] Bt Cotton - No Respite for Andhra Pradesh Farmers More than 400 crores' worth losses for Bt Cotton farmers in Kharif 2005 Centre for Sustainable Agriculture: Press Release, March 29, 2006 http://www.gmwatch.org/archive2.asp?arcid=6393;
see also November 14, 2005 article in www.NewKerala.com regarding Madhya Pradesh.

[7] Jaideep Hardikar, One suicide every 8 hours, Daily News & Analysis (India), August 26, 2006 http://www.dnaindia.com/report.asp?NewsID=1049554

[8]Rick Weiss, U.S. Rice Supply Contaminated, Genetically Altered Variety Is Found in Long-Grain Rice, Washington Post, August 19, 2006;

[9] Jeffrey Smith, US Government and Biotech Firm Deceive Public on GM Corn Mix-up, Spilling the Beans, April 2005

[10] See for example, Christopher Doering, ProdiGene to spend millions on bio-corn tainting, Reuters News Service, USA: December 9, 2002

[11] See www.centerforfoodsafety.org

[12] Office of Inspector General, USDA, Audit Report Animal and Plant Health Inspection Service Controls Over Issuance of Genetically Engineered Organism Release Permits, December 2005 http://www.thecampaign.org/USDA_IG_1205.pdf

[13] Justin Gillis, Genetically Modified Organisms Not Easily Contained;

National Research Council Panel Urges More Work to Protect Against Contamination of Food Supply, Washington Post, Jan 21, 2004

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The following statement is from Dr Erina Ermakova of the Russian Academy of Sciences in response to a statement by the UK's Advisory Committee on Novel

Foods and Processes (ACNFP) that questioned the validity of a study carried out by Dr Ermakova. Dr Ermakova's study found that where female rats were fed on GM soya their progeny were five times more likely to die within three weeks of birth than those of mothers fed on normal soya. Also, many of the baby rats born to mothers fed the GM soya diet were seriously underweight. Genetically modified organisms could be real threat to the life.

(Reply to ACNFP on the "Statement on the effect of GM soy on newborn rats").

Irina Ermakova

On November 2005 I got a letter from the Food Standards Agency in London, the government department that has responsibility for food safety issues in the UK with the request to send them information about my experiments. I sent them the text, indicating that there was a short version of the paper with some results, which were described already, and that I was preparing a big paper with more data. At that moment I was so shocked by the results of my own experiments that appealed to scientists of different countries to repeat my experiments or to help us to continue the researches. I indicated this request also in my answer to Food Standards Agency. After that the "Statement on the effect of GM soy on newborn rats" of Advisory Committee of Novel Foods and Processes (ACNFP) has appeared. The Statement of ACNFP on my results surprised me very much.

Committee did not pay real attention to possible danger of genetically modified organisms (GMO) obtained in my experiments, but concentrated on details of their realization.

The hazard of genetically modified or transgenic organisms was described for humans, animals and the Environment in many scientific investigations (Ho and Tappeser, 1997; Traavik, 1999; Chirkov, 2001; Wilson et al., 2004; Kuznetcov and Kulikov, 2006 and many others). Four main sources of the hazards of GMO are accepted by scientists worldwide: 1) those due to the new genes, and gene products introduced; 2) unintended effects inherent to the technology; 3) interactions between foreign genes and host genes; and 4) those arising from the spread of the introduced genes by ordinary cross-pollination as well as by horizontal gene transfer (World Scientists' Statement, 2000). Experimental researches showed negative effects of GMO on insects (Birch et al., 1996; Losey, 1999; Zangerl et al., 2001). It was found that consumption of GM-food by animals led to the negative changes in their organs (Pusztai, 1998, 2001; Ewen and Pusztai, 1999; Malatesta et al., 2002, 2003; Vecchio et al., 2003; Prescott et al., 2005 and others). However there is great lack of investigations concerning the influence of GMO on physiological state and behavior of rats and their offspring. It was the reason why I started my own experiments directed on this kind of investigations.

Our experiments showed a danger of Ready Roundup soy-bean (line 40.3.2), modified by the transgene CP4 EPSPS, for rats and their offspring. Supplementation of the diet of the females with GM soy led to the higher mortality of rat pups (more than one half) in comparison with the pups from control groups. High pup mortality was observed for every litter from mothers fed by the GM soy flour. Third of pups were sick and weighed several times less, than pups from the control groups. The obtained data showed a high level of anxiety and aggression in rats from the GM-soy group: females and rat pups attacked and bit each other and the worker who took care about them.

Pathological changes were found in testes and in liver of males fed by GM-soy seeds (Ermakova, Barskov, 2006, in press). In our experiments we did not succeed to get the second generation (F2).

Our data allow us to suppose that the negative effect of the GM-soy on newborn pups could be a result of transformation of foreign genes, which could penetrate into the sexual/stem cells or/and into cells of the fetus, as it was observed by Schubert and colleagues (1998). In their experiments the plasmids containing the green fluorescent protein (pEGFP-C1) gene, or the bacteriofaphage M13 DNA was fed to pregnant mice. Using the polymerase chain reaction (PCR) or the fluorescent in situ hybridization (FISH) method, foreign DNA, orally ingested by pregnant mice, was discovered in various organs of fetuses and of newborn animals. GM-soy is one of the GM-plants, created by the help of bacterial DNA plasmids (Agrobacter tumefaciensis method). So, we can assume that plazmids able for replication are kept in the cells of GM-plants (in our case in the GM-soy).

The affect on sexual cells and reproductive organs of rats by plasmids with foreign DNA from GM soy could be occurred. So, we can have "plazmid effect", that is more dangerous than virus infection, because plasmids can affect bacteria, plants, animals and human.

Also a negative effect of GM-soy on rats could be mediated by the highly mutagenic nature of the GM transformation process, described by Windels et al. (2001) and Wilson et al., (2004) or/and by accumulation of Roundup residues in the GM-soy shown by Richard et al., 2005.

We repeated similar experiments three times in four groups: "GM-soya" group, "Trad-soya" group, "Protein-isolate GM-soya" group and "Control" group. Committee analyzed preliminary study of the first two experiments in three groups, comparing my draft paper with the published paper of D.G. Brake, D.P. Evenson "A generational study of glyphosate-tolerant soybeans on mouse fetal, postnatal, pubertal and adult testicular development" (B& E). I believe that our researches are so various, that cannot be compared:

1. Different scheme of feeding. In my experiments I started to feed animals before mating, suggesting that foreign genes penetrate and effect the sexual cells and/or organs. In the experiments of B&E "pregnant mice were fed a transgenic soybean or a non-transgenic (conventional) diet through gestation and lactation... Multi-generational studies were conducted in the same manner". Thus genes could influence only on embryonic cells protected by the mother's organism, not on sexual cells or organs before mating.

2. Different subjects of investigations. In my experiments I analyzed the mortality, physiological state and behaviour of pups, B&E - fetal, postnatal, pubertal and adult testicular development.

3. B&E used very small number of pups for the study at each point "At each point three male mice were killed, the testes surgically removed, and the cell populations measured by flow cytometry" and for mating "Two C3H/HeJ males and two C3H/HeJ females were bred to keep that strain pure". In my experiments I used more females and males for mating and 10-20 times more pups in each group.

4. Different species of animals: in my experiments - rats, in B&E - mice.

5. I presented to Food Standards Agency the draft version but not the final one as paper of B&E. So, it was clear that the investigations of B&E and mine were quite different and both researches were incomplete. So, it is necessary to perform complex researches, including histological, genetical, and embryo-toxicological investigations by different scientific groups (including international ones). Scientists should be responsible for the obtained data, but are even more responsible for concealment of the received data, especially if somebody's life depends on them. A lot of independent investigations showed hazard of GMO for alive organisms. I hope very much that ACNFP will help us to perform detailed and complex investigations and to stop uncontrolled distribution of and contamination by imperfect genetically modified organisms that can cause such human diseases as cancer, allergy, brain and heart diseases, can lead to disappearance of a great number of different species of useful bacteria, plants and animals and cause destruction of the nature and the biosphere.

The results of my researches were published in English and in Russian:

1. Ermakova I.V. Genetically modified organisms and biological risks.

Proceedings of International Disaster Reduction Conference, Davos, Switzerland, August 27 –September 1, 2006, pp.168-171.

2. Ermakova I. Influence of genetically modified soya on the birth-weight and survival of rat pups// Proceedings "Epigenetics, Transgenic Plants and Risk Assessment", 2006, pp.41-48.

3. Ermakova I.V. Genetically modified soy leads to the decrease of weight and high mortality of rat pups of the first generation. Preliminary studies" EcosInform 1, 2006, pp.4-9 (in Russian).

4. Ermakova I.V. The effect o GM-soay on rats and their posterity. The first International Forum on Patient safety. January 23-24, 2006. p.30.

5. Ermakova I.V. Diet with the food, modified by gene EPSPS CP4, leads to the anxiety and aggression in rats. 14th European Congress of Psychiatry. Nice, France, March 4-8, 2006.

6. Ermakova I.V. Mine field of genetics//State management of resources. 2006, N2, pp.44-52 (in Russian).

7. Ermakova I.V. Genetics and ecology. In: Actual problems of science. Moscow, 2005, pp.53-59 (in Russian).

*********************************************************

 

All plantings of BT corn (maize) varieties are harmful and illegal

 

IT IS NOW INCONTROVERTIBLE THAT ALL PLANTINGS OF BT MAIZE VARIETIES (eg MON810 and Bt176) IN EUROPE ARE HARMFUL AND THUS ILLEGAL UNDER DIRECTIVE 2001/18.  HOW MUCH MORE EVIDENCE DO THE 'EXPERTS' AT DEFRA, ACRE, FSA, ACNFP, EFSA ETC ACTUALLY NEED?  ARE THEY ALL STUPID?  WHATEVER THEIR PERSONAL PROBLEMS MAY BE, THEY ARE CERTAINLY GUILTY (EACH ONE OF THEM, PERSONALLY) OF THE WILFUL SUPPRESSION OF EVIDENCE AND OF CRIMINAL NEGLIGENCE.

Directive 2001/18 is enshrined in law, and every time a Bt variety is planted, cultivated or harvested  ("deliberately released into the environment") the law is being broken (1) (2).

The notes below just refer to plant toxicity, microbiology and insect life.  There are other studies too (eg Bt cotton), relating to mammals including human beings.  There is now so much evidence of harmful toxic effects associated with Bt varieties that all past approvals by the EC must be revisited.  The approvals procedures for GM varieties "in the pipeline" must also be stopped instantly.   If they are not, that would be interpreted by any reasonable person as connivance in environmental damage and in the extension of public health risk  by EFSA and by Commissioners Dimas and Kyprianou in particular.

Evidence of ecological damage associated with Bt varieties is presented below from Germany, Hungary and Australia. Some of this material has been in the public domain for 2 years or more, but it has been systematically and cynically disregarded by the EC.

-------------------------------

(1)  GERMANY

Thanks to Jonathan Latham for drawing attention to this:

Lang,A and Vojtech, E:  "The effects of pollen consumption of transgenic Bt maize on the common swallowtail, Papilio machaon L. (Lepidoptera, Papilionidae), Basic and Applied Ecology 7 (2006), pp 296-306

This is a careful lab-based peer-reviewed study which used moderate pollen densities in accordance with densities found in the field.  The authors point out that field pollen densities can be much higher in the pollen shedding period, which lasts from 5 - 14 days.  During this period the toxic effects of Bt exposure will clearly be more marked (including greater larvae mortality rates and reduced reproductive success in butterflies) than those revealed in the study.  Note that these effects are specific to Bt176 pollen -- they have nothing to do with herbicide applications.

The study used Bt176 maize from the Navares (Syngenta) cultivar.  The work was financed by the State Government of Bavaria.

Quotes:

"Bt toxins are produced in most tissues of the Bt maize, and pollen with toxin may be transported by wind into adjacent areas, deposited on plants, and consumed by larvae of non-target species feeding on these plants."

"Consumption of Bt176-maize pollen had adverse effects on life history traits of the common swallowtail.  P machaon larvae fed with Bt pollen had a lower survival, a lower weight increase rate, a longer development time, and lower body-weight and smaller wing size as adults, and these effects were significantly associated with Bt pollen density."

"The study demonstrated toxic effects pf Bt176 maize pollen on P. machaon..."

"Bt consumption enhances the negative impact of bacterial infections on Lepidoptera larvae..."

"This study and the papers of Felke et al showed that the Bt176 maize has the potential to adversely effect larvae of European butterflies."

"We conclude that possible effects of Bt maize on European butterflies and moths must be evaluated more rigorously before Bt maize should be cultivated over large areas."

-------------------------

(2)  HUNGARY

Recent Hungarian work also confirms that Inachis io (L) (European Peacock) and Vanessa atalanta (L) (Red Admiral) (Nymphalidae) can be affected negatively by Bt pollen from the MON810 maize line.  Both species (which are protected) feed on great nettle, a common weed in the water furrows of maize fields in Hungary.  The eggs of these species hatch at exactly the time of maize pollination.  See this:

Darvas, b et al:  "Some data on the risk analysis of Bt-corn pollen and protected Lepidoptera species in Hungary", Novenyvedelem 40 (9) (2004) pp 441 - 449

A furious row has broken out between EFSA and the Hungarian Agriculture Ministry, which has imposed a temporary prohibition order on plantings of MON810 maize in the country.  This prohibition was based upon environmental and ecotoxological studies in the field by a team of Hungarian scientists, and part of the row centres on the fact that EFSA has chosen to pass judgment on these studies without having any expertise in the relevant areas.

The Hungarian team found the following for MON810 maize:

 1.  "The Bt maize produces 1500-2000 times as much Bt-toxin as is released through a single treatment in conventional crop protection, with the chemical called DIPEL, which contains Bt toxin."

2. "Other experiments have found that the residues of Bt plants are slower to decompose than their isogenic lines. Some 8% of the toxin produced by the plant remained in the field after harvesting. Indeed, a substantial share of this active toxin quantity could be identified in the soil 11 months later."

3. "In the soil of the field under the transgenic plant, the entire biological activity was lower than in the control field."

4. "The caterpillars thriving on herbs in and on the edges of maize fields, hatching during the pollination period, are the most substantially affected by the Bt toxin produced by MON 810."

On this basis, the Hungarians argue that any use of MON810 in maize plantings is in direct contravention of the National Nature Conservation Plan with respect both to protected habitats and protected insect species.

The Hungarians are also furious that EFSA invited Monsanto to comment on the Hungarian research work and accepted an anonymous critique from the company and circulated it to Member states without comment and indeed without prior notification of the research team.  This action is referred to as "unacceptable" and "deeply offensive".  The Hungarians are also furious with Monsanto, which has refused to supply seeds for a continuation of the research work and has refused to supply standards for the content of Cry 1Ab toxins in the relevant maize varieties.  The EC is effectively accused of conniving with Monsanto in this refusal to cooperate with the research.

 

--------------------------

(3)  AUSTRALIA

A reminder of this (circulated via GM-Act in May of this year):

Some  Australian research not widely reported.......... It refers to Cry1Ac  toxin and backs up the findings of the Hungarian team including Bela Darvas.  It relates to Bt cotton plants, but the conclusions can reasonably be extrapolated to Bt maize and to other cultivated plants containing Bt toxins.

From Gupta and Watson:

Quote:  " ..... We have shown that different plant parts of Bt cotton (leaves, stubble and roots) contain large concentrations of Bt toxin and therefore have the potential to be a reservoir of Bt toxin in agricultural fields of Australia."

Quote:  "............  our results suggest that Bt toxin has the potential to enter the soil system throughout the Bt cotton growing season, through both a root release process and root turnover. Levels of Bt toxin entering the soil system could therefore be significantly higher than previously suggested ......."

Quote:  " .....  roots with Bt toxin are in constant contact with the soil system (including soil biota) and Bt toxin levels in fine roots were found to be as high as that in younger leaves. In view of the results reported above (large concentrations of Bt toxin in Bt cotton roots and demonstrated root release), more detailed investigations on the environmental fate of the root-derived Bt toxin, binding to soil components and build up, and movement beyond the rhizosphere and root zone, are warranted."

The concerns of the authors shine through, although they are careful (so as to keep their paymasters happy) not to flag up "harm" or even the potential for harm.  We can see the heavy hand of CSIRO here, in playing down the significance of the findings.  But this research is very relevant, given the new revelations about sheep deaths in India among animals grazing on Bt cotton plants.

------------------

"Ecological impacts of GM cotton on soil biodiversity --Below ground production of Bt by GM cotton and Bt cotton impacts on soil biological processes"

Dr Vadakattu VSR Gupta and Dr Stephanie Watson Consultancy report by CSIRO Land and Water, August 2004 http://www.deh.gov.au/settlements/publications/biotechnology/gm-cotton/summary.html

========================================

NOTES

1. There are many clauses in the Directive than can be invoked, including Article 8 Clauses 1 and 2 which state (a) that if and when new information becomes available relating to the risks to health and the environment associated with a GM crop, the notifier (or seed owner) shall take appropriate protective steps; and (b) the competent authority shall evaluate the new information, communicate it to the public, and if necessary suspend or terminate the release authorization.  Neither Monsanto nor Syngenta has shown any inclination to protect either the environment or the public, and the EC and its advisory bodies have proved themselves to be incapable of standing up to the multinationals or revisiting past decisions.   The Safeguard Clause may be invoked by member states (Article 23) to provisionally restrict of prohibit a GM variety deemed to be unsafe or harmful;  however, the EC always seeks to overturn "precautionary" actions by various nations based upon this clause.  The Cartagena Protocol (Article 32) is for the purposes of GM assessments disregarded by the EC.  The preamble to the Directive states that where there are risks to the environment, preventive action must be taken; but it never is.  The precautionary principle must also -- in theory -- be taken into account in the implementation of the Directive; on the contrary, it has been comprehensively abandoned by the EC.  The various national laws which contain the essence of Directive 2001/18/EC are in many cases more severe -- for example, the UK Environmental Protection Act 1990 places more stress on the Precautionary Principle and supposedly affords additional protection to designated wildlife sites and other protected landscapes and ecosystems.  The UK GMO Deliberate Release Regulations 2002 are also "tighter" in some respects than Directive 2001/18;  but in the event the UK government has a tendency to see all GMOs as wonders of biotechnology, and invariably votes for GM approvals however inadequate and corrupt the applicant's supporting information may be.
1. See also Clause 36 of the following legal advice to FoE Europe, published in January 2005: http://www.foeeurope.org/press/2005/Coexistence%20-%20Lasok%20Advice.pdf

Brian John

GM Free Cymru

************************************

 

 The following statement is from Dr Erina Ermakova of the Russian Academy of Sciences in response to a statement by the UK's Advisory Committee on Novel Foods and Processes (ACNFP) commenting on a study carried out by Dr Ermakova 

Dr Ermakova's study found that where female rats were fed on GM soya their progeny were five times more likely to die within three weeks of birth than those of mothers fed on normal soya. Also, many of the baby rats born to mothers fed the GM soya diet were seriously underweight.

In its statement the ACNFP, which has attracted accusations in the past of being highly partisan on the GM issue, drew a critical comparison between Dr Ermakova's study and one by Brake and Everson. ACNFP stated:

"…Dr Ermakova's findings are not consistent with those described in a peer-reviewed paper published in 2004.1 In a well controlled study no adverse effects were found…" http://food.gov.uk/multimedia/pdfs/acnfpgmsoya.pdf

This statement by ACNFP has already drawn criticism from Dr Arpad Pusztai, who has argued that this comparison with Brake and Everson is invalid, because there were major differences in the two studies. Dr Pusztai also criticised the implication that Brake and Everson's research was of a superior quality.

For Dr Pusztai's comments:
http://www.gmwatch.org/archive2.asp?arcid=6154

For ACNFP's statement:
http://food.gov.uk/multimedia/pdfs/acnfpgmsoya.pdf

For a profile of the head of the ACNFP:
http://www.gmwatch.org/profile1.asp?PrId=176&page=G

Genetically modified organisms could be real threat to the life.
(Reply to ACNFP on the "Statement on the effect of GM soy on newborn rats").

Irina Ermakova

    On November 2005 I got a letter from the Food Standards Agency in London, the government department that has responsibility for food safety issues in the UK with the request to send them information about my experiments. I sent them the text, indicating that there was a short version of the paper with some results, which were described already, and that I was preparing a big paper with more data. At that moment I was so shocked by the results of my own experiments
that appealed to scientists of different countries to repeat my experiments or to help us to continue the researches. I indicated this request also in my answer to Food Standards Agency. After that the "Statement on the effect of GM soy on newborn rats" of Advisory Committee of Novel Foods and Processes (ACNFP) has appeared. The Statement of ACNFP on my results surprised me very much.
Committee did not pay real attention to possible danger of genetically modified organisms (GMO) obtained in my experiments, but concentrated on details of their realization.

    The hazard of genetically modified or transgenic organisms was described for humans, animals and the Environment in many scientific investigations (Ho and Tappeser, 1997; Traavik, 1999; Chirkov, 2001; Wilson et al., 2004; Kuznetcov and Kulikov, 2006 and many others). Four main sources of the hazards of GMO are
accepted by scientists worldwide: 1) those due to the new genes, and gene products introduced; 2) unintended effects inherent to the technology; 3) interactions between foreign genes and host genes; and 4) those arising from the spread of the introduced genes by ordinary cross-pollination as well as by horizontal gene transfer (World Scientists' Statement, 2000). Experimental researches showed negative effects of GMO on insects (Birch et al., 1996; Losey, 1999; Zangerl et al., 2001). It was found that consumption of GM-food by animals led to the negative changes in their organs (Pusztai, 1998, 2001; Ewen and Pusztai, 1999; Malatesta et al., 2002, 2003; Vecchio et al., 2003; Prescott et al., 2005 and others). However there is great lack of investigations concerning the influence of GMO on physiological state and behavior of rats and their offspring. It was the reason why I started my own experiments directed on this kind of investigations.

    Our experiments showed a danger of Ready Roundup soy-bean (line 40.3.2), modified by the transgene CP4 EPSPS, for rats and their offspring. Supplementation of the diet of the females with GM soy led to the higher mortality of rat pups (more than one half) in comparison with the pups from control groups. High pup mortality was observed for every litter from mothers fed by the GM soy flour. Third of pups were sick and weighed several times less, than pups from the control groups. The obtained data showed a high level of
anxiety and aggression in rats from the GM-soy group: females and rat pups attacked and bit each other and the worker who took care about them. Pathological changes were found in testes and in liver of males fed by GM-soy seeds (Ermakova, Barskov, 2006, in press). In our experiments we did not succeed to get the second generation (F2).

Our data allow us to suppose that the negative effect of the GM-soy on newborn pups could be a result of transformation of foreign genes, which could penetrate into the sexual/stem cells or/and into cells of the fetus, as it was observed by Schubert and colleagues (1998). In their experiments the plasmids containing the green fluorescent protein (pEGFP-C1) gene, or the bacteriofaphage M13 DNA was
fed to pregnant mice. Using the polymerase chain reaction (PCR) or the fluorescent in situ hybridization (FISH) method, foreign DNA, orally ingested by pregnant mice, was discovered in various organs of fetuses and of newborn animals. GM-soy is one of the GM-plants, created by the help of bacterial DNA plasmids (Agrobacter tumefaciensis method). So, we can assume that plazmids able
for replication are kept in the cells of GM-plants (in our case in the GM-soy). The affect on sexual cells and reproductive organs of rats by plasmids with foreign DNA from GM soy could be occurred. So, we can have "plazmid effect", that is more dangerous than virus infection, because plasmids can affect bacteria, plants, animals and human.

Also a negative effect of GM-soy on rats could be mediated by the highly mutagenic nature of the GM transformation process, described by Windels et al. (2001) and Wilson et al., (2004) or/and by accumulation of Roundup residues in the GM-soy shown by Richard et al., 2005.

We repeated similar experiments three times in four groups: "GM-soya" group, "Trad-soya" group, "Protein-isolate GM-soya" group and "Control" group. Committee analyzed preliminary study of the first two experiments in three groups, comparing my draft paper with the published paper of D.G. Brake, D.P. Evenson "A generational study of glyphosate-tolerant soybeans on mouse fetal, postnatal, pubertal and adult testicular development" (B& E).

I believe that our researches are so various, that cannot be compared:

1.  Different scheme of feeding. In my experiments I started to feed animals before mating, suggesting that foreign genes penetrate and effect the sexual cells and/or organs. In the experiments of B&E "pregnant mice were fed a transgenic soybean or a non-transgenic (conventional) diet through gestation and lactation... Multi-generational studies were conducted in the same manner". Thus
genes could influence only on embryonic cells protected by the mother's organism, not on sexual cells or organs before mating.

2.  Different subjects of investigations.  In my experiments I analyzed the mortality, physiological state and behaviour of pups, B&E - fetal, postnatal, pubertal and adult testicular development.

3.  B&E used very small number of pups for the study at each point "At each point three male mice were killed, the testes surgically removed, and the cell populations measured by flow cytometry" and for mating "Two C3H/HeJ males and two C3H/HeJ females were bred to keep that strain pure". In my experiments I used more females and males for mating and 10-20 times more pups in each group.

4.  Different species of animals: in my experiments - rats, in B&E - mice.

5.  I presented to Food Standards Agency the draft version but not the final one as paper of B&E.

So, it was clear that the investigations of B&E and mine were quite different and both researches were incomplete. So, it is necessary to perform complex researches, including histological, genetical, and embryo-toxicological investigations by different scientific groups (including international ones).
Scientists should be responsible for the obtained data, but are even more responsible for concealment of the received data, especially if somebody's life depends on them. A lot of independent investigations showed hazard of GMO for alive organisms. I hope very much that ACNFP will help us to perform detailed
and complex investigations and to stop uncontrolled distribution of and contamination by imperfect genetically modified organisms that can cause such human diseases as cancer, allergy, brain and heart diseases, can lead to disappearance of a great number of different species of useful bacteria, plants and animals and cause destruction of the nature and the biosphere.

The results of my researches were published in English and in Russian:

1.  Ermakova I.V. Genetically modified organisms and biological risks. Proceedings of International Disaster Reduction Conference, Davos, Switzerland, August 27 –September 1, 2006, pp.168-171.
2.  Ermakova I. Influence of genetically modified soya on the birth-weight and survival of rat pups// Proceedings "Epigenetics, Transgenic Plants and Risk Assessment", 2006, pp.41-48.
3.  Ermakova I.V. Genetically modified soy leads to the decrease of weight and high mortality of rat pups of the first generation. Preliminary studies" EcosInform 1, 2006, pp.4-9 (in Russian).
4.  Ermakova I.V. The effect o GM-soay on rats and their posterity. The first International Forum on Patient safety. January 23-24, 2006. p.30.
5.  Ermakova I.V. Diet with the food, modified by gene EPSPS CP4, leads to the anxiety and aggression in rats. 14th European Congress of Psychiatry. Nice, France, March 4-8, 2006. 
6.  Ermakova I.V. Mine field of genetics//State management of resources. 2006, N2, pp.44-52 (in Russian).
7.  Ermakova I.V. Genetics and ecology. In: Actual problems of science. Moscow, 2005, pp.53-59 (in Russian).

*************************************************
___

Dr Arpad Pusztai's review of Dr Epstein's book "What's In Your  Milk?"

 
NOTE: Dr. Arpad Pusztai is a world-renowned nutritional scientist and  expert on the safety of genetically modified foods, who has published over 300  primary scientific papers. Dr. Epstein is professor emeritus of environmental  medicine at the University of Illinois at Chicago School of Public Health and  the recipient of multiple awards, including the 2005 Albert Schweitzer Golden 
Grand Medal "for Humanitarianism, and International Contributions to Cancer  Prevention."
---
---
1.A review of Dr Samuel S. Epstein's book "What's  In Your Milk?" (Trafford Publishing)
by Arpad Pusztai
Consultant; Genok  (Norwegian Institute of Gene Ecology), Tromso, Norway
 
Dr Epstein's new book, "What's In Your Milk?," describes and discusses in  detail the scientific, and human and veterinary safety issues arising out of the use by Monsanto of recombinant bovine growth hormone (rBGH) in milk production.  Despite the well-known considerable difficulties of obtaining financial support  for independent studies into the safety of any genetically engineered
(GE)  product, be it GE food, and GE or cloned meat, Dr Epstein's thesis is  well-documented and supported by a large number of academic studies published in  peer-reviewed science journals. In short his points are as follows:
 
*Natural bovine growth hormone, BGH and the various commercial recombinant  rBGHs are chemically and immunologically different.
 
*rBGH milk is chemically and nutritionally different from normal milk and,  amongst other things, contains more long-chain fatty acids and less casein  protein and can be contaminated with pus, antibiotics, and other chemicals,  etc.
 
*Milk from cows injected with rBGH contains some of the recombinant hormone  which, at least in part, can be absorbed from the gut into the blood circulation  of consumers with possible, but at present unknown, physiological effects that  should need further extensive studies to elucidate.
 
*There is overwhelming evidence to show that milk from cows injected with  rBGH contains elevated levels of the potent growth factor IGF1 that is readily taken up from the gut into the systemic circulation where, according to some evidence, is suggested to be implicated in the development of tumors in breast,  colon and prostate tissues and in blocking apoptosis of transformed cells;
thus  counteracting a natural defence mechanism in cancer.
 
*Injection of cows with rBGH increases the development of adverse  veterinary effects, such as mastitis with a need for medication with antibiotics  and other chemicals some of which contaminate the milk from these cows and/or  the frequently observed digestive and reproductive disorders, including reduced  fertility, that are now fully or partly acknowledged to occur by Monsanto and  the FDA.
 
*Most of these points are not only confirmed by published studies but they are also corroborated by Monsanto's own studies as described in a batch of confidential files to the FDA that were leaked to Dr Epstein anonymously in October 1989.
 
In addition to describing the ins-and-outs of the safety of rBGH milk, one of the prominent and nowadays unfortunately commonplace scientific controversies  arising out of the involvement of industrial and business interests in what used  to be mainly scientific issues, Dr Epstein's book has very strong social,  political and ethical messages for scientists and also for the general public.  Dr Epstein very commendably gives fully all the arguments, pro- and contra, that  appear to support the respective cases of the opposing sides in the 
controversial issue of the safety for human consumption, animal health and other  pertinent issues associated with the use of rBGH-treated cows, their milk and  meat.
 
However, those not directly immersed in the scientific issues of rBGH milk  and who are not familiar with the published papers cited in support of safety may not find it easy to apportion what weight, if any, to attach to the scientific value, strength and validity of the publications referred to.  Although it may not surprise those scientists who are familiar with such  controversies and who have themselves been financed by commercial money that in  some of the industrial responses to Dr Epstein's charges concerning the possible 
dangers of the rBGH technology, the references are not always what they appear  to be.
 
For example, in the "Previously Unpublished Industry Response from  Cyanamid" (August 16, 1989,  pp. 56-63) it is said: "His (i.e. Dr  Epstein’s) allegations are unsubstantiated and ignore the fact that results of  this research (i.e. supporting the industry's case) are "published in  peer-reviewed journals which are subjected to intensive scrutiny by the  scientific community at large." One would therefore expect that the Cyanamid  authors to support their case
quoted mainly peer-reviewed papers. In fact, most  of what purported to be peer-reviewed papers were abstracts or short resumes of  talks given at conferences. Thus, to rebut Dr Epstein's thesis on negative  energy balance in rBGH-treated cows all five references cited were conference  communications. Or to discredit Dr Epstein's allegation of increased incidence  of infectious diseases, one of the papers cited in the text was not given in the  reference list, two were conference pieces and one was a general paper not  directly pertinent to the rebuttal. Again, on the questionable efficacy of milk  hormones the authors quoted four papers, all of which were conference reports.  And so on!
 
Although this finding does not necessarily question their validity, it is 
disappointing that the authors' arguments were not based on more peer-reviewed  publications that are "subjected to intensive scrutiny by the scientific  community". Unfortunately, the FDA scientists' response to Dr Epstein's charges  published in Science (vol. 249, pp. 875-884, 1990) has also been rather  disappointing. Apart from the fact that the paper contains little, if any,  direct clinical evidence to support the claimed human safety of rBGH-milk or  meat, practically all the work cited comes from previously unpublished  confidential
industry studies on animals (all in all 16 references) with very  little
independent work supporting their results. One would expect in such a  scientific, and even more importantly, public health controversy that reliance  should not be based only or mainly on research by scientists working for the very industry that is to commercialise the product.
 
Should some readers regard the rBGH story, for the want of a better 
expression, as a showcase for scientists squabbling amongst themselves about a  topic only interesting to them, they would be quite mistaken. The book is  exciting reading for all. It vividly describes the developing story and  controversy between the antagonists with all the turns of an exciting detective  novel.
Every trick in the book by the industry is illustrated, particularly the 
shenanigans of Monsanto in cohoots with the FDA and the US administration, aided  and abetted by the "revolving door" between official and industry personnel,  setting up hit-squads to discredit "awkward" scientists, putting out misleading  or false information in the press, suppressing nationally and internationally relevant scientific information on safety, or the lack of it, of their product,  leaning on political, regulatory and other bodies, committees and organizations  and putting pressure on their personnel, just to name a few of the
strategies  used.
 
That, after all, the Monsantos of this world still fail in this case is due 
to Dr Epstein's persistence, scientific track record and international
standing,  his hard detective work and unflagging drive to get to the truth in the unfailing belief that it is the duty of an honest scientist to serve the public.  This is a great book and one which all other books in the field of genetic engineering will be measured against.

  

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Herbicide resistant crops may pose a very serious threat was recently revealed by the Institute for Responsible Technology. Aside from the possibility of genetic resistance to herbicides being passed on to bacteria in the human and animal gut, the herbicides absorbed by these GM plants in which they remain inactive, may be unbound and become active in the digestive system after being consumed. The risks to pregnant women may be significant. Brain development abnormalities, growth retardation and death have been documented in mammalian fetuses exposed to glufosinate, one of the most widely used herbicides.

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The oil-shortage panic move in the U.S to ill advised ethanol production from corn will mean more plantings of GM varieties, less land for livestock feed, and for human food-crop production to stockpile for humanitarian emergency relief food programs that are in more demand than ever with climate change.

Arguably the worse case scenario of non-sustainable industrial agriculture is the U.S. government’s commodity crop support program that subsidizes corn and soybean production---crops, now predominantly GM, that result in serious soil erosion and water pollution from agrichemicals--- at an estimated $ 12.2 billion. Such subsidies are a disincentive to farmers to adopt more ecologically sound farming practices.

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Genetically Modified Corn Study Reveals Health Damage and Cover-Up

Spilling the Beans, June 2005

http://www.organicconsumers.org/Monsanto/spillbeans0605.cfm

THIS MONTH'S ARTICLE:

Genetically Modified Corn Study Reveals Health Damage and Cover-up <mip://031b4d88/default.html#GM_Corn_Study>

Including:
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* Faulty Comparisons Hide Problems
<mip://031b4d88/default.html#Faulty_Comparisons>
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* GM Food is Prone to Unpredicted Effects
<mip://031b4d88/default.html#GM_Food_Prone>
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* Flaws in the Mon 863 Study Should Have Caused It to be Rejected
<mip://031b4d88/default.html#Flaws_in_the_Mon>
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* The Politics of Science Fails to Protect the Public
<mip://031b4d88/default.html#Politics_of_Science>
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* US Pushes its Agenda, and its Pests, on Europe
<mip://031b4d88/default.html#US_Agenda>
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* Additional Information <mip://031b4d88/default.html#Information>
The following article describes a study revealing health problems associated with a genetically modified corn and the attempts by Monsanto and European regulators to distort the findings. As this longer-than-normal column provides in-depth analysis of a current newsworthy controversy, please pass this article on to reporters who can freely reprint in whole or in part, or use it as background material.

Genetically Modified Corn Study Reveals Health Damage and Cover-up

By Jeffrey M. Smith, author of Seeds of Deception

When a German court ordered Monsanto to make public a controversial 90-day rat study on June 20, 2005, the data upheld claims by prominent scientists who said that animals fed the genetically modified (GM) corn developed extensive health effects in the blood, kidneys and liver and that humans eating the corn might be at risk. The 1,139 page research paper on Monsanto¹s ³Mon 863² variety also revealed that European regulators accepted the company¹s assurances that their corn is safe, in spite of the
unscientific and contradictory rationale that was used to dismiss
significant problems. In addition, the study is so full of flaws and
omissions, critics say it wouldn¹t qualify for publication in most journals and yet it is the primary document used to evaluate the health impacts.

Mon 863 is genetically engineered to produce a form of a pesticide called bacillus thuringiensis or Bt, designed to attack a corn pest called the root worm. Rats fed Mon 863 developed several reactions, including those typically found with allergies (increased basophils), in response to infections, toxins and various diseases including cancer (increased lymphocytes and white blood cells), and in the presence of anemia (decreased reticulocyte count) and blood pressure problems (decreased kidney weights).
There were also increased blood sugar levels, kidney inflammation, liver andkidney lesions, and other changes. According to top research biologist Arpad Pusztai, who was commissioned by the German government to evaluate the study
in 2004, based on the evidence no one can say that Mon 863 will cause cancer or allergies or anything specific. The results are preliminary and must be followed-up to rule these out. He warns, however, ³It is almost impossible to imagine that major lesions in important organs. . . . or changes in blood parameters. . . . that occurred in GM maize-fed rats, is incidental and due to simple biological variability."

French Professor Gilles-Eric Seralini, a molecular endocrinologist at theUniversity of Caen, agrees that the results indicate a toxic reaction. Seralini is a member of two French government commissions that evaluate GM food, one of which originally rejected a request for approval of the corn variety in October, 2003 due to the adverse findings of the study. Seralini won a French lawsuit allowing him to express his concerns in public, and now Greenpeace has won a German court battle that makes public the data that is the source of his concerns.

Pusztai and Seralini spoke about the Mon 863 study at a June 22 press conference in Berlin organized by Greenpeace. Both scientists are uniquely qualified to evaluate the study. Seralini studies endocrine disruptors and the impact of pesticides on health. He was one of four experts appointed to respond to the WTO challenge filed by the US against the European Union¹s policy on GM food and crops. He has read all of the industry¹s GM-food submissions to Europe as well as all the commentaries on the submissions.
Pusztai is the leading authority in his field of protein science (lectins)
and had been commissioned by the UK government in the 1990s to develop the ideal testing protocol for all GM foods. Although his protocol was supposed to be adopted by the UK government and eventually in Europe, Pusztai¹s controversial finding that GM potatoes damaged the health of rats ultimately stopped the work. Pusztai has also been commissioned to evaluate all published studies on GM foods, and has analyzed most of the confidential submissions made by industry.

Both scientists have expressed alarm about the unsupported arguments that Monsanto and some European regulators use to force product approvals. Now that the Mon 863 study is available, other scientists and the public can evaluate the industry¹s defense, which Pusztai and Seralini say contradict well established scientific principles. Chief among their concerns are the ways Monsanto explains away statistically significant effects.

Faulty Comparisons Hide Problems

In animal feeding studies, researchers attempt to minimize differencesbetween the test animals and the control groups, so that only the impact ofthe item being analyzed will stand out. In this study therefore, the testrats ate Mon 863 and the control group ate non-GM corn from the same parent line, i.e., corn whose genetics are the same except for the insertion of the genetic material and its impact. When comparing the results of these two appropriate groups, the health impacts were unambiguous and occurred at a rate that the scientific community accepts as not due to chance. But Monsanto and their supporters in the European Food Safety Authority (EFSA)
appear to throw away the accepted methods of science that have been used for decades in order to rationalize the findings.

1. Researchers used six additional control groups, which were fed commercialcorn varieties with entirely different genetics. While such comparisons are appropriate for commercial studies, it is entirely inappropriate for a safety assessment, according to Pusztai. Monsanto claimed that when the changes in the test rats were compared to this much larger, irrelevant control group, many changes were no longer significant.

2. In spite of the strained logic, many results were still statistically
significant when compared to these six other controls and were reported as such by the laboratory that Monsanto used to conduct the study. Monsanto therefore ignored the study¹s figures and claimed that since the changes in the rats were still within a wide range of reactions that are normal for the animals, they should be considered biologically irrelevant. Using this argument, for example, they declared that a 52% decrease in reticulocytes (immature blood cells) was ³attributable to normal biological variability.²
According to Pusztai, an allowance of 5% variability is the norm in food experiments. Similarly, he says that the increase in blood sugar levels by 10% ³cannot be written off as biologically insignificant, given the epidemic of diabetes.²

To put Monsanto's claims into perspective, suppose that a large number of women who were fed a carefully controlled diet had a 25% increase in breast cancer compared to matched controls on another diet. Using Monsanto's logic, the findings can be dismissed because the increase was still within the normal variability of breast cancer for the whole population.

3. In spite of the statistical slight-of-hand, several results could still
not be dismissed since they were well beyond the range Monsanto had defined as normal. So the company claimed that the potentially dangerous health effects were not considered significant because the reaction among the rats was not consistent between males and females. "This is really ridiculous," says Seralini, because everyone studying cancer and endocrinology, for example, knows that there are differences between genders.

4. When even the gender defense could not be applied to a particular
finding, Monsanto dismissed it since the reactions were not always dose specific. Specifically, the results observed in rats fed a diet that was 11% Mon 863 were sometimes more pronounced than results found in rats fed a 33% diet. Seralini notes that in endocrinology and toxicology research, differences are not always proportional to effects noted. A small dose of a hormone, for example, can cause a woman to ovulate, while a larger dose can
make her infertile.

5. When all other excuses failed, Monsanto claimed that with such a large study, one would expect lots of results to fall in the statistically
significant category purely by chance. Thus, no follow-up is required.

Seralini says, "It is dishonest not to do the tests again if you have
statistical significance." Pusztai similarly asks, "What is the point of
doing a study if you dismiss the results you find?" He insists that you
design a study specifically so that statistical significance indicates
biological significance.

In spite of the fact that Monsanto's explanations were at odds with
time-honored principles of science, the European Food Standards Agency (EFSA) recommended that Mon 863 be approved. In fact, the agency's justification mimics that of Monsanto, point for point. In spite of EFSA's recommendation to approve Mon 863, the majority of the countries in the EU Council of Ministers voted not to approve the corn on July 24, 2005. But EU law requires a "qualified majority" on such a vote, and so the pro-GM European Commission is now authorized to make the decision and is expected to approve Mon 863 within a few months.

Mon 863 will not be the first approved GM food in Europe to have shown significant health effects in rats. According to Seralini, an oilseed rape (GT 73), Roundup Ready corn (NK 603), and two Bt corn varieties (Bt11 and Mon 810) all showed statistically significant problems that regulators did
not pursue with follow-up research. Seralini said that the effects of the GM crops were similar to that of pesticides. Some included inflammation disorders and problems in the livers and kidneys, the two major organs involved with detoxification. Seralini is part of a research group raising money to do independent research on a GM variety he says showed more than 50 significant rat anomalies.

GM Food is Prone to Unpredicted Effects

How can a GM crop create so many significant unpredicted side effects? There are several ways. The process of gene insertion, for example, typically results in hundreds or thousands of mutations throughout the genome. Insertion also changes the amount of protein that natural genes produce (5% of the genes in one study) and can destroy natural genes altogether. The protein created by the inserted gene may also create allergies or toxins.
Several studies indicate, for example, that the Bt pesticide may cause allergic or immune system effects. Furthermore, according to Monsanto's submission on Mon 863 to Australia and New Zealand, some of the foreign genetic material that was added into the corn was mutated during the insertion process. This means that the composition of the Bt protein that the corn creates is actually different than the one scientists intended.

With so many ways to create side effects, many scientists and consumer groups are demanding extensive evaluations and insist that a simple 90-day rat experiment is not competent to protect the public. In the EU, pesticide approvals require research on three types of mammals, with feeding studies ranging from 90 days to two years. Seralini points out that Bt crops create new pesticides. Mon 863, for example, is unique; it differs from the natural version of Bt pesticide in seven ways and should, according to Seralini, require at least the same level of evaluation as chemical pesticides. The
same holds true for herbicide tolerant crops, which are engineered to
survive large applications of weed killers such as Monsanto's Roundup.
Seralini points out that these GM plants have far more herbicide residues in the edible portions and extensive toxicity tests must be performed. But the biotech industry claims that they could not afford to introduce GM crops if they had to pay for the tests normally required for pesticides in Europe. For GM crop approvals in the US, they spend even less. US authorities require only 30-day studies for the Bt plants and no safety tests whatsoever are required for herbicide tolerant varieties.

Flaws in the Mon 863 Study Should Have Caused It to be Rejected

According to Pusztai, the quality of Monsanto's study was well below that normally required for a peer reviewed publication. He says, "It is odd, therefore, that it remains the central document considered by government regulatory authorities upon which to make a decision to protect the health of European citizens."

Several features of the study appear to have been rigged to avoid findingproblems. Nutritional studies, for example, typically use young, fast-growing animals, which are sensitive to toxic and nutritional effects. By using a mix of young and old animals, Monsanto's research design may have hidden serious problems. Similarly, they used rats with a huge range of
starting weights. According to Pusztai, the starting weights in a rat feeding study should not vary more than 2% from the average. By contrast, the male starting weights in Monsanto's study ranged from 198.4 to 259.8 grams (or 143 to 186 grams according to the conflicting data in the study's appendix). In either case, says Pusztai, the wide range "can make it
impossible to find significant differences in animal weights at the end of the experiment."

Monsanto tested the effects of two diets: in one Mon 863 constituted 33% of the rats' diet, and in the other, it was 11%. Even in the 33% group, GM corn protein comprised only about 15% of the rats' total protein. According to Pusztai, researchers should have started with the maximum amount of corn possible (while maintaining a balanced diet), and then used lower concentrations to evaluate any dose effect. (Since rats are stand-ins for humans, it is interesting to note that African aid recipients typically rely on corn for 90% of their total caloric intake.) Researchers also supplemented the corn with a commercial animal feed. Although its composition wasn't reported, it may have contained GM soy, which could have skewed the results.

The study relied on analytical methods that are half a century old and
ignored powerful new methods, such as profiling techniques, DNA chips, proteomics, and others. They relied on just two observation times (week 5 and week 14), which will not give data about the intervening periods. And the short 90-day time period will miss chronic and reproductive problems, as well as problems in the next generation.

The analysis of the findings was obscured by using six irrelevant control groups fed commercial diets, as well as data from historical databases. Such comparisons are totally unacceptable in the field of nutrition. According toPusztai, "The study should have included a control group fed the non-GM parent line, spiked with the Bt obtained from the Mon 863. If rats reacted badly to this diet, it would show that the genetic engineering process and its unpredicted side effects, and not the Bt toxin, were responsible. Pusztai says, "A second parental line spiked with a known toxin would also be useful as a positive control," to make sure the measurements are sensitive enough to detect the expected impact of the toxin. Without this, it is difficult to know if the methods were working properly.

Monsanto also defended changes in kidney weights by comparing the values with a separate study, which used different corn genetics and a different lab. According to Pusztai, this absurd inter-experimental comparison is
never done and should be disregarded.

Some of the reported weight measurements were also bizarre, suggesting possible problems with animal management or faulty data. One rat dropped 53 grams in one week and gained 102 grams in the next. Some that were heaviest at the beginning of the experiment were the lightest at the end. And the
rats hardly grew at all during the last four weeks.

Overall, the research paper was confusing, conflicting, and poorly reported. It failed to disclose, for example, the nutritional composition of the feed - backed up by chemical analysis - and the methods used to measure changes in the animals. Since these most basic requirements for a nutritional study were not provided, the research cannot be repeated and the results remain suspect.

Referring to the study as a whole, Pusztai says, "Nutritional scientists and leading journals would not accept these blatant inadequacies and misinterpretations."

The Politics of Science Fails to Protect the Public

When Seralini wanted to voice his concerns about the industry's safety studies, he was told by French authorities that he was legally bound to keep even his opinions confidential. A lawsuit eventually granted him the right to speak, but until June 20, 2005, biotech companies were able to keep their feeding studies hidden by claiming that they contained confidential business information. Seralini says that "No one can understand, even among EU
regulators, why the composition of the blood of rats that have eaten the GM is secret."

The precedent established by the German court may open the doorfor more biotech studies to be made public. Without disclosure, says Seralini, just a few toxicologists can make the decision without public evaluation. And too often, the decision-making body is heavily influenced by the applying company.

In his French Commission for Biomolecular Genetics (CBG), for example, the government nominates three candidates for the position of the very important "external referee." That referee studies the application and presents the relevant facts to the 18-member committee. For about ten years, the applicant companies such as Monsanto were able to choose which candidate of the three was to be the referee overseeing their products' approval process.
Seralini says, "I had a big fight with the commission" over the conflict of interest. As a result, the government changed the rules, and for the Mon 863 application they allowed the president of the commission the right to choose the referee. The president, however, is a geneticist who works very closely with industry. He appointed the same person that the biotech industry had chosen in the past.

After the CBG failed to approve Monsanto's corn in 2003, the president asked for an outside scientist to re-evaluate just one of the significant differences - kidney weight. According to Seralini, the consultant ignored the blood and liver disorders entirely. And no additional research was actually conducted; the consultant simply re-examined the same data and
declared the results insignificant.

The commission scheduled another vote, but failed to achieve a quorum. The president ruled that a quorum would not be needed in the next meeting, and only five members showed up. The president cast the deciding vote that approved Mon 863, 3 votes to 2. The
other votes in favor came from the commission's vice-president, who works at an organization that conducts agricultural research, and a scientist.
According to Seralini, the scientist is a toxicologist who, oddly enough, is "always against long animal toxicity tests." In fact, he had been part of the French committee that approved Novartis (now Syngenta) E 176 corn after it had been tested for only two weeks with three cows. Actually, there were four cows at the start of the study, but one died and was removed.

The toxicologist is also on the European Food Standards Agency that endorsed Mon 863. EFSA has come under attack for including primarily pro-GM scientists. According to a November 2004 report by Friends of the Earth, "One member has direct financial links with the biotech industry and others have indirect links. . . . Two members have even appeared in promotional videos produced by the biotech industry." And several members, including the chairman, have been part of an EU-funded project with the stated goal to "facilitate market introduction of GMO's in Europe."

US Pushes its Agenda, and its Pests, on Europe

The United States government's support for biotech is no secret. In fact, it is the official policy in several US agencies to promote the industry, and some of them have attempted to push acceptance of GM crops in Europe. In the case of Mon 863, it seems that the corn is designed to solve a European problem that the US introduced. The corn is engineered with a pesticide to attack insects such as Diabrotica. According to Seralini, "Diabrotica is from a very dangerous family of insects for a wide range of crops and was
absent from the European countries until the late 1990s, forbidden even in laboratories because it is very difficult to eliminate it with known chemical insecticides." He says it appears to have entered Europe from the US in large numbers during the Balkan war. Specifically, it was widespread around US military airports, whose planes were likely to have carried the pest. It has since spread primarily in Italy, France, and Germany.

According to Seralini, "Monsanto seems to have anticipated this problem." Before any infestation had been discovered, they were already field testing their corn in France in the late 1990s. Since it takes about five years of local field trials for a GM variety to be accepted in an EU nation, such early testing was necessary.

In addition to the crop pests, Europe may have also imported the US
tradition of approving GM products based on faulty studies. Documents stolen from the US FDA reveal that when Monsanto's researchers intended to illustrate that their GM bovine growth hormone did not interfere with cows'; fertility, they allegedly added cows to the study that were pregnant prior to injection. An FDA whistle-blower also charged that sick cows were removed from industry studies altogether (see Seeds of Deception, chapter 3).

Critics demand that regulators use independent studies, not industry
studies, to prevent manipulation of data. But there are only a few
independently funded researchers. Biology professor Bela Darvas of Hungary's Debrecen University is one of them. After discovering that one of Monsanto's Bt corn varieties, Mon 810, is lethal to two Hungarian protected species and one insect classified as a rare, he ran into an unexpected obstacle. Now Monsanto refuses to give him any more Mon 810 corn to use in his tests. They also refused his request for Mon 863.

Perhaps with the court's release of Monsanto's rat study, the public will demand a more thorough investigation into GM foods and a change in the review and approval process. Until then, Europeans are relatively safe from the unintended effects, since most manufacturers refuse to use even approved GM ingredients there (with the exception of animal feed). Meanwhile, consumers in the US will unwittingly serve as the guinea pigs.

Additional Information
For Dr. Arpad Pusztai¹s review comments commissioned by the German authorities on both the full 90-day study and a Monsanto summary, go to:
http://www.gmwatch.org/p1temp.asp?pid=66&page=1

For Dr. Pusztai's review, in easy-to-read table form, of some of the
significant differences found in the rat-feeding study, go to
www.seedsofdeception.com/utility/showArticle/?objectID=220

For Dr. Pusztai's list of reasons why the Mon 863 study should have been rejected, go to www.seedsofdeception.com/utility/showArticle/?objectID=219

See detailed information on the study provided by Professor Seralini to the Greenpeace press conference at:
http://www.greenpeace.ca/f/documents/campagnes/ogm/MON_863_Seralini_june05.pdf

For the full 1139 page study, go to:
http://www.monsanto.com/monsanto/content/sci_tech/prod_safety/fullratstudy.pdf

For Monsanto's 11 page summary of safety information, go to:
http://www.monsanto.com/monsanto/content/sci_tech/prod_safety/ratstudy.pdf

For the Friends of the Earth report on conflicts of interest in the European Food Standards Agency, go to:
www.foeeurope.org/GMOs/publications/EFSAreport.pdf

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This GMO news service is underwritten by a generous grant from the Newman's Own Foundation, edited by Thomas Wittman and is a production of the Ecological Farming Association
<http://www.foeeurope.org/GMOs/publications/EFSAreport.pdf> www.eco-farm.org
<http://www.eco-farm.org/>
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<http://www.foeeurope.org/GMOs/publications/EFSAreport.pdf>