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.lobbywatch.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

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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 mammals 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 Schubbert and colleagues (1998). In their experiments food with 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 could 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 verysmall 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. 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. 14^th 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).

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