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Author Topic:   Time for a New Ethics
Harpyr
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posted March 24, 2006 01:35 PM     Click Here to See the Profile for Harpyr     Edit/Delete Message   Reply w/Quote
Published on Friday, March 24, 2006 by Inter Press Service
A New Ethics Needed to Save Life on Earth
by Mario Osava

CURITIBA, Brazil - Emotions and sensitivity are "the essence, the core dimension of the human being," said the Brazilian theologian at a panel on "ethics, biodiversity and sustainability". The panel formed part of the Global Civil Society Forum, held parallel to the Mar. 20-31 Eighth Conference of the Parties to the Convention on Biological Diversity (COP8).

It is not reason but feeling that is involved in our first contact with reality, and "today's great crisis is not economic, political or religious, but a crisis of affect, of the capacity to feel a connection with others," he said.

It is indispensable to "take care of all living things," and science shows that cooperation is the "supreme law of the universe," he added.

"The world is not made up of objects but of relationships. It was cooperation that made possible the leap from animal to humanity, and without it we are dehumanised, which is what occurs in the case of capitalism," the theologian told around 300 activists, most of them small farmers.

He added that the principle of responsibility underlies the criticism of transgenic products, the need to take precautions in the face of unpredictable and unknown consequences, the possibility that genetic modification of food could break down the balance between the "billions of bacteria" and molecules that make up a human being.

Boff, who left the priesthood after suffering sanctions at the hands of the Vatican for expressing "dangerous ideas" over the past two decades, has outlined his ecological concerns in several books. He has been invited to give talks at several panels at the COP8.

Boff is one of the founders of liberation theology, which is based on a "preferential option for the poor", whose proponents' involvement in the struggles of the poor and marginalised sectors of the population often brought them into conflict with a more conservative Catholic Church hierarchy in the past.

The expression "sustainable development" is "a deception to undermine the demands of environmentalists" by joining together two contradictory concepts, he told the participants in the Global Civil Society Forum.

Development "comes from the capitalist economy," which supposes a constant rise in production, consumption and wealth as part of an illusion of "infinite resources," while sustainability has to do with biology, "the dynamic equilibrium of interrelated beings," he said.

In order for the consumption levels of industrialised countries to become universal, "two additional planet earths" would be needed, he said.

But earlier international conferences have already concluded that by continuing along that road, the earth would no longer be sustainable by 2030 or 2035, and would suffer major catastrophes, said Boff. "We have become the earth's Satan," said Boff. "Either we change or we die."

An equally menacing portrait was painted by Louise Vandelac, director of the Environmental Sciences Institute at the University of Quebec at Montreal (UQAM), Canada. Vandelac focussed on the area of biotechnology, and warned that more than biodiversity, it is "the world's biological security that is threatened by the cannibalism of the market."

A second generation of transgenic research and technology has now emerged, devoted to producing genetically modified animals, she said.

The research being carried out today is very different from that of the previous 25 years, she noted. Scientific literature from the last few months reveals that more than 200 tests have already been conducted on pigs, rabbits, cows and fish, and soon the first transgenic salmon could be unveiled in Canada, she reported.

This technology has been highly concentrated up until now, with just four countries - the United States, Argentina, Brazil and Canada û accounting for 96 percent of transgenic commercial production. Moreover, 95 percent of this production is made up of only four crops, namely soybeans, cotton, corn and canola. In the meantime, Monsanto Roundup Ready (RR) soybeans occupy a full 75 percent of the total area planted with transgenic crops in the world today.

The biotechnology industry's marked interest in developing pesticide-resistant plant varieties owes to the fact that producing a new pesticide costs ten times more, said Vandelac.

Roundup Ready seeds, which produce crops that are resistant to Monsanto's own glyphosate-based herbicide Roundup, have guaranteed continued sales of the weedicide. The use of Roundup on transgenic crops dropped off during the first few years, but is now growing at a rate of four percent annually.

Studies reveal a 70 percent decline in the toad population in areas where transgenic soybeans are grown. One hypothesis is that Roundup herbicide is altering the animals' hormonal systems and thus interfering with their reproduction, said Vandelac.

Nevertheless, there are "new hopes" emerging as people are becoming more aware of the threats posed by transgenics and pushing for clear regulations that enforce limits on the ambitions of private enterprise, with social movements joining with environmentalists, trade unionists, feminists and other activists in defence of biological security, she concluded.

Argentine lawmaker Marta Maffei called for efforts to combat "cultural domination," the mother of all dominations, in her view.

Maffei maintained that politicians adopt decisions "without knowing anything about environmental issues," and depend on the advice of specialists who work for private companies that have no interest whatsoever in preserving biodiversity.

Social mobilisation is the only way to break this "vicious cycle of environmental domination," she declared.

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lotusheartone
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posted March 24, 2006 02:54 PM           Edit/Delete Message   Reply w/Quote
leap from animal to humanity..ahahahahahahahahahahahahahahahaha

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goatgirl
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posted March 24, 2006 03:10 PM           Edit/Delete Message   Reply w/Quote
Not only are these crops modified to be resistant to herbicides, they have somehow managed to pass along this resistance to Roundup to the weeds which inhabit the fields with them.

SOAEFD flexible Fund Project RO 818

Report of Project Coordinator on data produced at the Rowett Research Institute (RRI)

ARPAD PUSZTAI, FRSE

22nd October, 1998

1. Introduction

In 1995 SOAEFD commissioned a 3-year multicentre project: Genetic engineering of crop plants for resistance to insect and nematode pests: effects of transgene expression on animal nutrition and the environment. The main objective of the programme was: "To identify genes encoding antinutritional factors which will be suitable for transfer into plants to enhance their resistance towards insect and nematode pests, but will have minimum impact on non-target, beneficial organisms, the environment, livestock fed on these plants, and which will present no health risks for humans either directly or indirectly through the food chain ".

Provision of genetically modified (GM) plants and measuring their environmental impact was the responsibility of the University of Durham (UD) and the Scottish Crop Research Institute (SCRI). The task of RRI was carry out thorough chemical analyses and establish whether the parent and transgene lines were compositionally equivalent or not and to determine in short-term (10 day) and long-term (3 months) rat feeding trials whether the effect of GM lines on the mammalian gut and metabolism was similar to that of parent lines or not. Our work has concentrated on tubers from GM-potato lines expressing the gene of snowdrop (Galanthus nivalis) bulb lectin, GNA, as this was the only GM crop plant which we received in time and in sufficient amounts to do nutritional trials with. No other lectin-expressing GM plants have been tested with rats although we did some analytical but no nutritional work on Con A-GM-potatoes which we received from SCRI well into the third year of the programme. This Report will therefore only describe the results of our analytical, nutritional and immunological work on GNA-GM-potatoes. For ease of reading, the main text will only give few data and only those necessary for understanding the significance of the findings. However, all the results will be given as Tables and Figures in a separate but linked Appendix allowing readers to check the accuracy and truthfulness of the conclusions drawn. All other non-essential and non-GM aspects of our work will be omitted from this Report as these can be found in the Audit Report produced by the Audit Commission.

2. Results & Discussion

2.1 Compositional analyses:

To facilitate the understanding of the relationship between the lines used in the study a lineage chart is given in Figure 1 (Appendix). Briefly, there were two original GNA-transformed lines 71/1 and 7411 and their derivatives which were used in this study. Lines 71/1 and 7411 were grown at Rothamstead and passed on to UD and SCRI respectively where second generations were grown in either tunnels (71/2T and 74/2T) or glasshouses (71/2G and 74/2G) together with their respective parent lines. The data of tuber composition given in Table 1 (Appendix) and the results of analyses of antinutrients in Table 2 (Appendix) are as comprehensive as possible. However, as some lines were scarce, not all GNA-GM-potatoes have been used in feeding studies. The ones which have, are printed in bold in the Tables.

The results clearly show that the contents of some or all of the constituents of major nutritional importance in GM-potatoes are significantly different from those of their respective parent lines. Thus, although the true protein content of the tubers of 71/1 lines (used in D227) is similar, the GNA-GM 74/2T potato line used in 3 of the main feeding trials (D237, D242 & D249), regardless whether raw or baked, contained nearly 20% less protein than its respective parent. The starch and/or glucose contents of the parent and GNA-GM tubers were also different. Similar findings were made for antinutrient contents. Thus, the potato lectin (PL) content of most GM lines was significantly different from the appropriate parent. Indeed, in one instance, the PL content of 74/26 GNA-GM line was well over double of that of the parent line. Similarly and almost without exception, contents of trypsin inhibitors and chymotrypsin inhibitors of the GM- and appropriate parent lines were significantly different. The results of changes in protein, starch, sugar, lectin and trypsin/chymotrypsin inhibitor levels in potato tubers after GNA gene insertion taken in conjunction with the preliminary results by SCRI scientists (Interim SCRI Report - FF 818; April 1998) showing decreased foliar glycoalkaloid content in various lines of GM-potatoes clearly "indicate possible gene silencing, suppression and/or somaclonal variation" as a result of gene insertion. It is therefore clear that in contrast to the conclusions of the Audit Report the GNA-GM-potato lines investigated as part of the Rowett's work programme in FF 818 were not "substantially equivalent" to the appropriate parent tubers.

2.2 Isolation of GNA from GNA-GM-potatoes and its identity with GNA from snowdrops.

Our work has clearly demonstrated that the GNA expressed in the potato tuber is similar (or identical) to the GNA in snowdrop bulbs. Using the same specific methodology of affinity chromatography as Van Damme et al. (Febs Lett. 215, 140, 1987) originally employed for isolating GNA from snowdrop bulbs, we have purified sufficient amounts of "potato GNA" to allow us to establish by SDS-PAGE, haemagglutination, mannose-inhibition of haemagglutination and specific ELISA that the potato and the snowdrop GNA molecules were closely similar, perhaps identical. This similarity was further underlined by our findings that the behaviour and binding of "potato GNA" in the gut on feeding GNA-GM-potatoes (D227) was similar to that of "snowdrop GNA" which was fed as part of a diet containing parent potatoes spiked with GNA (Table 3). Interestingly, GNA levels in the tuber appeared to decrease on re-growing (Table 2) although further studies are needed to confirm this.

2.3 Rat feeding studies

a. Background considerations:

There were four feeding trials using GNA-GM-potatoes but none with Con A-GM-tubers. The protein content of potato tubers was low and the potato proteins were of relatively low quality to fully support the growth of young rats and to conform to Home Office requirements. Unfortunately this meant that according to the basic principles of nutritional science any potential differences in nutritional value between GM and parent potatoes may be diminished and/or abolished by the presence of lactalbumin. An additional complication was due to major differences in protein content between some of the transgenic and parent lines. Therefore to formulate iso-nitrogenous diets all diets needed supplementation with different amounts of a high nutritional quality protein, lactalbumin, leading to further complications in the design of the experiments. However, this "protein effect" was expected to be less important in short-term (10 day) trials than in the long-term (110 day) experiment because the reserves of the animals could compensate for dietary imbalances. Therefore we concentrated on 10-day rat feeding trials and carried out three such experiments. Protein imbalance was a particularly acute problem in our long-term study (D237) because the GNA-GM-potato tuber, 71/2T, the line which was available in sufficient amounts (close to 100 kg) for feeding and also extensively used in the insect trials, contained almost 20% less protein than its appropriate parent line. Thus, to make the diets isoproteinic the GM-potato diets contained 26% more lactalbumin (LA) than the diet based on the parent line. Therefore, D237 should be regarded as a preliminary study from whose results we might be able to modify the diet in such a way that the next trial could be made under ideal conditions.

b. Experiment D227:

This was a preliminary 10-day study because tubers of the line 71/1 GNA-GM and its parent from Rothamstead were needed for re-growing at SCRI. No lymphocyte proliferation assays were done in this experiment. The total protein content of the raw potato diets was about 61 g/kg diet which was made up of 55 g potato protein/kg and just under 6 g LA/kg diet. With boiled potatoes the contribution of potato proteins was about 5 g less and therefore the total protein content of the boiled diet, including LA was only about 56-57 g/kg diet. These dietary protein concentrations were far less than the minimum of 10-12% thought to be required for proper growth. The following diets were tested: Raw parent, Raw parent + GNA, Raw transgenic, Boiled parent, Boiled parent + GNA, Boiled transgenic and LA control. All rats were pair-fed with the diets.

The growth curves and the wet weight data in Appendix 7 of the Audit Report are correct. Briefly, as expected, rat growth was significantly reduced on boiled potato diets and even more on diets containing raw potatoes. Therefore the presence of GNA, whether added to potato-based diets or expressed in the transgenic tuber line 71/1 had no significant effect on weight gain and weight change compared to parental controls although the difference between the final body weight and the empty body weight of rats (accounting for the food removed by washing) which were fed raw transgenic potato diets was more than that of rats given diets containing the raw parent line. Although the difference was not significant in this experiment (while it was in D242) the trend indicated that digestion and absorption of transgenic potato-based diets was retarded in comparison with ordinary potato diets.

Furthermore, and more importantly, there were highly significant differences in the wet and dry weights, both absolute and relative weights, of many essential body organs (Table 4), indicating that the effects of GNA-GM-potatoes on body and organ metabolism were significantly different from those of control potatoes. Although the Audit Committee apparently had these very data in their possession, they were not included in their Report even though that some of the effects, such as the partial liver atrophy observed on feeding boiled transgenic potato-based diets may have major repercussions on liver function. Other effects which included the enlargement of the pancreas, jejunum and testes on raw GNA-GM-potato diets suggested that the lack of compositional equivalence might also be extended to a lack of equivalence in the metabolic consequences between feeding of GM and parent potatoes. This is of particular importance because as shown before (Table 3) this occurs despite that the behaviour in the gut lumen of "potato GNA" after GNA-GM-potato diets was closely similar to that of "snowdrop GNA" in parent potato diets spiked with GNA (Table 3).

c. Experiment D242:

This was 10-day trial using second generation tubers of GNA-GM-potatoes 71/2T line and a mixed control consisting 19% 71/2T and 81% 74/2G control lines due to the short supply of 71/2T control potatoes. In addition to observing the nutritional and metabolic effects of feeding rats with transgenic potatoes for 10 days, in this experiment we also carried out mitogenic lymphocyte responsiveness measurements to test the effects of these diets on immune function using the well-established lymphocyte proliferation assay.

The total protein content of the 71/2T GNA-GM potato tubers was less than that of the 71/1 lines and therefore in the transgenic diets potato proteins contributed less than 43 g protein to the total of 55 g/kg. The difference was made up by supplementing the diet with 12 g LA/kg diet (twice of that in D227). The mixture of the 71/2T and 71/2G control potatoes contained more protein (Table 1) and these diets therefore contained 51.8 g potato proteins and 12 g LA, making a total of over 63 g protein/kg diet. The following diets were tested: Raw parent, Raw parent + GNA, Raw transgenic, Boiled parent, Boiled parent + GNA, Boiled transgenic and LA control. All rats were pair-fed.

The results were similar to those in D227 and the growth curves and the wet weight data in Appendix 9 of the Audit Report are correct. Briefly, as expected, rat growth was significantly reduced on boiled potato diets and even more on diets containing raw potatoes compared with LA diet. Therefore the presence of GNA, whether added to potato-based diets or expressed in the transgenic tuber line 71/1 had no significant effect on weight gain and weight change compared to parental potato lines. However, in this instance the difference between the final body weight and empty body weight of rats (accounting for food in the gut lumen) which were fed raw transgenic potato diets was significantly higher than that of rats given diets containing the raw parent line. This again indicated that digestion and absorption of nutrients of transgenic potato diets was retarded in comparison with ordinary potato diets.

Feeding rats with diets containing raw GNA-GM-potato tubers 71/2T for 10 days induced significantly large changes in the absolute and relative wet weights of most major organs in comparison with parent line diets (Table 5). Most of the changes were leading to reduction in organ weights of transgenic potato-fed rats and this may have been the result of the significantly reduced rate of digestion and absorption of nutrients in the digestive tract of these animals. This effect was reversed with the thymus and gastrocnemius muscle. Feeding rats with baked transgenic potatoes also significantly affected some of their vital organs including the kidneys, thymus and gastrocnemius muscle (Table 5). Similar to findings in D227 feeding rats diets containing the baked transgenic line reduced their liver weight but the results were not significant in this case.

No dry weight data have been obtained in this study.

Results of our immune assays clearly indicated that incorporation of raw transgenic potatoes in the diet highly significantly depressed the responsiveness of rat peripheral lymphocytes to both Concanavalin A (Con A) and Phaseolus vulgaris agglutinin (PHA) as mitogens. As the results were the same as in Appendix 9 of the Audit Report these are not reprinted. However, as on re-evaluation some of the significances became slightly different, the T-test results are tabulated in Table 6 and Table 7. Although the depression of lymphocyte proliferation was less with baked transgenic potato diets vs baked parent diets, at 6 m g Con A/well mitogen concentration the difference was significant (p < 0.05). Moreover, even in those cases where the differences were not statistically significant the trend was unmistakeable: lymphocytes from rats given transgenic potato diets were almost always less responsive to mitogenic stimuli than those from rats fed parent line diets. It was particularly interesting that in contrast to the depression with GNA-GM-potato diets, GNA added to parent potatoes, regardless whether raw or baked, had in some instance stimulated the responsiveness of the lymphocytes, thus increasing the differences between transgenic and parent lines.

d. Experiment D237

This was the only long-term experiment carried out with GNA-GM-potatoes, line 71/2T. However, only baked transgenic and parent potatoes could be used in the diets as in preliminary studies we found that weight gains with raw potatoes were so much depressed that they would have breached Home Office rules. In addition to observing the nutritional and metabolic effects of feeding rats with transgenic potatoes for 110 days, in this experiment we also carried out mitogenic lymphocyte responsiveness measurements to test the effects of these diets on immune function using the well-established lymphocyte proliferation assay.

As the protein content of the 71/2T GNA-GM potato tubers was lower than that of the parent lines it was nearly impossible to formulate isoproteinic diets with them. Moreover, to overcome the likely low growth rates when rats are long-term fed on diets of inadequate protein content, it was decided to increase the amounts of the high-quality LA protein used for diet supplementation even though that feeding such diets might diminish (abolish) possible differences between the effects of transgenic and parent potato diets. Thus, as in the transgenic diets potato proteins contributed less than 41 g protein to the total of 88 g/kg, this diet contained more high-quality LA protein, 47 g LA/kg diet, than potato protein. The mixture of the 71/2T and 71/2G control potatoes used parent control contained more protein (Table 1) and these diets therefore contained 49 g potato proteins and 35 g high-quality LA, making a total of 84 g protein/kg diet. The following diets were tested: Baked parent, Baked parent + GNA and Baked transgenic. In a separate study groups of rats were fed LA control diet (94 g LA/kg diet) or LA diet + GNA. All rats were pair-fed.

The growth curves and the wet weight data in Appendix 8 of the Audit Report are correct and therefore are not duplicated here. Clearly, rats fed all of the potato diets grew slightly but significantly less well than pair-fed LA controls. However, to maintain such an equal growth rate with the potato diets the transgenic diet not only had to contain more total protein (8.8%) than the parent line diets (8.4%) but also it had to be supplemented with over a quarter more LA than the control. LA is a nutritionally better quality protein than potato proteins and therefore its high dietary inclusion may have contributed to the generally similar organ weights of rats whether fed transgenic or parent line diets. The only significant difference found was in the liver weight. However, in contrast to all previous studies (D227 and D242) in which there was a partial liver atrophy in rats given transgenic potatoes, in this experiment both the absolute and relative weights of the liver of the animals on the transgenic diet were significantly (p < 0.05) increased compared to the parent control. This suggested that it was possibly the higher dietary level of the high quality LA in the transgenic diet that might have caused a general increase in the organ weight of the rats on this diet. This was further supported by the findings that when the effects of the transgenic diet were compared with those of the parent + GNA spike, the weights of other organs, such as the caecum, kidneys and thymus also became significantly different.

The scale of the lymphocyte responsiveness of rats fed potato diets was so much compressed that no significant differences were found between transgenic and parent lines. The results given in Appendix 8 of the Audit Report are therefore not duplicated here. Clearly, under the conditions of long-term feeding with potatoes many factors contributed to the overall highly depressed lymphocyte responsiveness. Thus, one of the possible major contributors could have been the same that caused the depression seen in transgenic-fed rats in the 10 day trial, D242.

In addition, it is also known that immune responses are also diminished by feeding animals on diets of low protein content particularly when the proteins in the diet are of poor nutritional quality such as potato proteins. Moreover, the cumulative depressing effect on long term feeding of some possibly harmful component(s) (lectins, protease inhibitors, glycoalkaloids etc) in potatoes could have also contributed to the depression of some of the functions of the immune system and for these reasons any potential effects of the transgene on the immune system may have been hidden. To clarify the role of these factors further studies are needed at time points intermediate between the 10 and 110 days used in this study.

e. Experiment D249

To overcome the problems and the immune depression caused by feeding potato diets of low protein content and quality an experiment was designed in which the protein content of the diet was increased well above the daily requirement of the rats. This 10-day feeding experiment was in progress during the sitting of the Audit Committee and therefore its results could not be evaluated by them. However, as the results of the feeding studies and the lymphocyte responsiveness assays make a very significant contribution to our understanding, they will be described here.

In this experiment the GNA-GM-potato line 71/1 and its corresponding control line was used. Potato proteins contributed 47 g protein to the total protein concentration of 147 g/kg in the diets; the rest was high-quality LA (100 g/kg diet). The high dietary level of LA was chosen deliberately to establish whether the differences in organ weights and lymphocyte responsiveness found in previous short-term experiments with diets containing low levels of LA could be overridden by greatly increasing the concentration of the high-quality LA in the diet, so that the protein concentration in the diets was superoptimal. Four major experimental groups (12 rats of each group) were set up: Raw parent, Raw parent + GNA, Raw transgenic and LA control. All rats were pair-fed.

At these high dietary protein concentration no significant differences were found in the growth rate of the rats (Figure 2). Even the LA control rats grew at the same rate. However, the empty body weight of the transgene-fed rats was significantly higher than that of the parent control. Moreover, despite the high LA concentration in all diets, there were still significant differences in organ weights between the rats fed transgene vs parent diets (Table 8). In addition to other organs, both the spleen and thymus appeared to be stimulated by feeding the rats on transgenic potato diets. It was also quite worrying that the previously observed partial liver atrophy and also a reduction in the size of the brain was still observed despite the expected levelling effect of the high concentration of the high-quality LA in the diet.

The lymphocyte proliferation assay carried out with spleenocytes showed the same trend as in D242 with significant differences in lymphocyte responsiveness between raw transgenic and parent lines. Apparently, even the high level of LA in the diet could not reverse the depressing effect of the transgene previously found at low dietary inclusion levels of the high-quality LA protein.

Summary conclusions:

After GNA gene insertion into potatoes changes in protein, starch, sugar, lectin and trypsin/chymotrypsin inhibitor levels were observed in the tubers of two generations of two GNA-GM lines suggesting "possible gene silencing, suppression and/or somaclonal variation" in the potato genome. The GNA-GM-potato lines investigated as part of the Rowett's work programme in FF 818 were therefore not "substantially equivalent" to the appropriate parent tubers.

Four feeding trials were carried out with two lines of GNA-GM-potatoes. In all four experiments feeding transgenic potatoes to rats induced major and in most instances highly significant changes in the weights of some or most of their vital organs. This was not abolished even when high-quality lactalbumin supplied two-third of the protein in the diet (D249). Particularly worrying was the partial liver atrophy observed with cooked transgenic potatoes in all short-time (10 day) studies. Immune organs, such as the spleen and thymus were also frequently affected. These results therefore indicated that similar to the lack of equivalence in composition there is also a lack of equivalence in the metabolic consequences between feeding of GM and parent potatoes even though that "potato GNA" in GNA-GM-potato diets appears to show functional equivalence to "snowdrop GNA" in parent potato diets spiked with GNA.

The growth rate of rats fed potato diets was slightly but significantly less than that of rats fed a high-quality control diet but the presence of GNA, whether added to potato-based diets or expressed in the transgenic tuber line 71/1, had no significant effect on weight gain and weight change compared to parent potato lines. However, in most instances the presence of GNA-GM-potatoes in the diet caused some slowing down the digestion and absorption of nutrients in the gut in comparison with parent line diets. This was only observed with diets in which potatoes supplied the major part of dietary protein (D227 and D242) and the effect reached full significance in experiment D242.

Feeding rats with GNA-GM-potatoes significantly reduced their lymphocyte responsiveness to mitogenic stimuli after 10 days compared to parent controls that was not abolished by raising the high-quality protein (lactalbumin) concentration to superoptimal nutritional levels. However, as in long-term feeding the lymphocyte proliferative response of all rats fed potato-based diets was reduced to non-stimulated levels, no significant differences were observed in lymphocyte responsiveness between GNA-GM-potatoes and their parent counterparts in long-term (110 day) feeding experiments.

Accordingly, the Coordinator of FF 818 SOAEFD commissioned programme is of the opinion that the existing data fully support our suggestion that the consumption by rats of transgenic potatoes expressing GNA has significant effects on organ development, body metabolism and immune function that is fully in line with the significant compositional differences between transgenic and corresponding parent lines of potatoes.

Monsanto to Public: Ignore the Rats and Eat the GMO Corn
OCA Reacts to Monsanto's Latest GMO Deception

May 24. 2005

LITTLE MARAIS, MN - Consumers have another reason to avoid genetically modified foods (GMO). Yesterday, European news outlets reported harmful health impacts on lab rats that were fed Monsanto's root worm resistant corn (Mon 863). Monsanto, the world largest maker of genetically modified corn, soybeans, canola and cotton appears to have disregarded their own research on the harmful impacts of their GMO corn on rats. According to the London based Independent which broke the story, "…secret research carried out by Monsanto shows that rats fed the modified corn had smaller kidneys and variations in the composition of their blood."

"This news couldn't have come at worse time for Monsanto which is already facing consumer mistrust of their products due to concerns over how GMO's impact the immune system, interfere with non-GMO crops and affect long term human health," says Ronnie Cummins, Executive Director of the Organic Consumer's Association. "European labeling laws require GMO ingredients to be listed making it easy to avoid them, but Americans and consumers are sitting ducks since no such labeling is required. The only way to be sure you are not eating GMO ingredients is to buy certified organic products."

Monsanto's latest deception stems from submitting only a summary of a 1,139 page report on Mon 863 corn to the European Food Safety Authority (EFSA). The summary left out the abnormalities in rats that were fed the GMO corn versus those who ate a different diet. "We demand Monsanto release the full report on the rat study which is being withheld from the science and medical community because it could be used by competitors for commercial purposes," says Cummins. Monsanto should put research on human health effects before corporate profits."

This isn't the first time GMO foods have been shown to impact the health of rats. A study on rats fed GMO potatoes in 1998 showed similar harmful impacts on their health. At the moment Mon 863 corn is not approved for importation to Europe, but is under consideration by EFSA for approval. Two GMO ingredients have been approved by the EFSA in the past year, while over ten proposed GMO foods have been not approved for importation during the same period.

"Since the Europeans lifted import bans on all GMO's, there has been increased scrutiny of commonly used GMO crops in the U.S. which is revealing new information about the safety of GMO's," says Cummins. "Most Americans don't know the foods they eat are considered unsafe in Europe."
http://www.organicconsumers.org/ge/corn-study.cfm


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After silence, that which comes nearest to expressing the inexpressible is music." - Aldous Huxley

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goatgirl
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posted March 24, 2006 03:13 PM           Edit/Delete Message   Reply w/Quote
GENETICALLY MODIFIED CORN STUDY REVEALS HEALTH DAMAGE & COVER-UP

By Jeffrey Smith
July 16, 2005
NewsWithViews.com

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 Monsanto’s “Mon 863” variety also revealed that European regulators accepted the company’s 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 wouldn’t 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 and kidney 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, “It 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 the University 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 Union’s policy on GM food and crops. He has read all of the industry’s 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, Pusztai’s 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 industry’s 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 differences between the test animals and the control groups, so that only the impact of the item being analyzed will stand out. In this study therefore, the test rats 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 commercial corn 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 study’s 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 “attributable to normal biological variability.” 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% “cannot be written off as biologically insignificant, given the epidemic of diabetes.”

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 finding problems. 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 to Pusztai, "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 door for 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.

GENETICALLY MODIFIED CORN STUDY REVEALS HEALTH DAMAGE & COVER-UP

By Jeffrey Smith
July 16, 2005
NewsWithViews.com

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 Monsanto’s “Mon 863” variety also revealed that European regulators accepted the company’s 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 wouldn’t 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 and kidney 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, “It 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 the University 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 Union’s policy on GM food and crops. He has read all of the industry’s 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, Pusztai’s 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 industry’s 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 differences between the test animals and the control groups, so that only the impact of the item being analyzed will stand out. In this study therefore, the test rats 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 commercial corn 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 study’s 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 “attributable to normal biological variability.” 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% “cannot be written off as biologically insignificant, given the epidemic of diabetes.”

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 finding problems. 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 to Pusztai, "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 door for 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

1, Dr. Arpad Pusztai’s review comments commissioned by the German authorities on both the full 90-day study and a Monsanto summary.
2, For Dr. Pusztai's review, in easy-to-read table form, of some of the significant differences found in the rat-feeding study, click here.
3, For Dr. Pusztai’s list of reasons why the Mon 863 study should have been rejected, click here.
4, See detailed information on the study provided by Professor Seralini to the Greenpeace press conference at: Click Here.
5, For the full 1139 page study, go to: click here.
6, For Monsanto's 11 page summary of safety information, go to: click here.
7, For the Friends of the Earth report on conflicts of interest in the European Food Standards Agency, go to: click here.

© 2005 Jeffrey M. Smith- All Rights Reserved

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Jeffrey M. Smith has been involved with genetically modified (GM) foods for nearly a decade. He worked for non-profit and political groups on the issue and in 1998, ran for U.S. Congress to raise public awareness of the health and environmental impacts. To protect children-who are most at risk from the potential health effects of GM foods-Smith proposed legislation to remove the foods from school meals. He also proposed legislation to help protect farmers from cross-pollination by GM crops. Later, he was vice president of marketing for a GMO detection laboratory.

Smith has lectured widely, spoken at conferences, and has been quoted in articles around the world. Prior to working in this field, he was a writer, educator, and public speaker for non-profit groups, advancing the causes of health, environment, and personal development. This book Seeds of Deception, researched and written after he left the industry, combines Smith's passion for these causes with his extensive knowledge of the risks and cover-ups behind genetically modified foods.

Smith is the founding director of the Institute for Responsible Technology, a member of the Sierra Club Genetic Engineering Committee, and a member of the advisory board of the Campaign to Label Genetically Engineered Foods. He has a master's degree in business administration and lives with his wife in Iowa, surrounded by genetically modified corn and soybeans.

Website: www.seedsofdeception.com
E:Mail: info@seedsofdeception.com

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After silence, that which comes nearest to expressing the inexpressible is music." - Aldous Huxley

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goatgirl
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posted March 24, 2006 03:16 PM           Edit/Delete Message   Reply w/Quote
EATING GENETICALLY ENGINEERED FOOD IS GAMBLING WITH YOUR HEALTH

By Jeffrey Smith
January 24, 2004
NewsWithViews.com

You probably eat genetically modified (GM) foods at every meal without knowing it. Most Americans do. While the biotech industry claims that the FDA has thoroughly evaluated GM foods and found them safe, internal FDA documents made public from a lawsuit, reveal that agency scientists warned that GM foods might create toxins, allergies, nutritional problems, and new diseases that might be difficult to identify.

Genetically modified foods are those which have foreign genes inserted into their DNA. While scientists originally assumed that the inserted genes would only add a particular desired trait to the crop, new evidence suggests that the host's normal natural genes can get switched off, turned on permanently, damaged, or altered in the process. And that's just some of the many ways that GM foods may create unpredicted and potentially dangerous side effects.

A January 2001 report from an expert panel of the Royal Society of Canada said it was "scientifically unjustifiable" to presume that GM foods are safe, and that the "default prediction" for any GM foods is the creation of unintended side effects. They called for safety testing, looking for short- and long-term human toxicity, allergenicity, and other health effects.[1]

Unfortunately, there have been very few safety studies. Of the 10 published animal feeding studies, the most in-depth one showed evidence of damaged immune systems, digestive problems, excessive cell growth, and stunted organ development in rats fed an experimental GM potato. The scientists identified the process of genetic modification as the probable cause-the same process used in creating most GM food on the market[2]. When the scientist went public with his findings, he was fired from his job after 35 years, and silenced with threats of a lawsuit. Unfortunately, no published study has yet tested the GM food on the market to see if they create these same damaging effects in laboratory animals or humans.

Rats fed the genetically modified FlavrSavr tomato developed stomach lesions. Seven of forty rats died within two weeks. The crop was approved, but has since been taken off the market.

The only human feeding trial ever conducted confirmed that genetically engineered genes from soy burgers and a soy milkshake transferred to the bacteria inside the digestive tract after only one meal, making the bacteria resistant to herbicide[3]. (The biotech industry had previously said that such a transfer was impossible.) The World Health Organization, the British and American Medical Associations, and several other groups have expressed concern that if the "antibiotic resistant marker genes" used in GM foods got transferred to bacteria, it could create super-diseases that are immune to antibiotics.[4]

In the 1980's a deadly epidemic was traced to the food supplement L-tryptophan, created from genetically modified bacteria. About 100 Americans died and an estimated 5-10,000 fell sick-some were permanently disabled. Biotech proponents successfully diverted the blame away from genetic engineering by attributing the disease to changes in the filtration system at the factory. It is now known, however, that hundreds had contracted the disease from genetically modified versions of L-tryptophan created during the four years prior to the change in the filter.

The disease created by the contaminated L-tryptophan was acute, rare, and came on quickly. If all three of these characteristics had not been present, it is unlikely that doctors would have identified the supplement as the cause; it might still be on the market. This begs the question, Are there other genetically modified products on the market creating serous health problems that are not being traced?

According to a March 2001 report, the Center for Disease Control says that food is responsible for twice the number of illnesses in the U.S. compared to estimates just seven years earlier. This increase roughly corresponds to the period when Americans have been eating lots of newly introduced GM foods. Could that be contributing to the 5,000 deaths, 325,000 hospitalizations, and 76 million illnesses related to food each year? It's hard to say since there is no monitoring in place.

In the UK-one of the few places that do annual evaluations of allergy statistics- soy allergies skyrocketed by 50% immediately just after GM soy was imported for the first time from the United States.[5] This might have resulted from the increased allergen, trypsin inhibitor, in the genetically modified Roundup Ready® soy[6] or perhaps from the protein in that soy that has never before been part of the human food supply.

Milk and dairy products from cows treated with the genetically engineered bovine growth hormone (bGH) milk contain an increased amount of the hormone IGF-1, which is one of the highest risk factors associated with breast[7] and prostate cancer.[8] The Council on Scientific Affairs of the American Medical Association called for more studies to determine if ingesting "higher than normal concentrations of
[IGF-1] is safe for children, adolescents, and adults."[9] In addition, Sam Epstein, M.D., Chairman of the Cancer Prevention Coalition and author of eight books, wrote, "bGH and its digested products could be absorbed from milk into blood, particularly in infants, and produce hormonal and allergic effects." He described how "cell-stimulating growth factors . . . could induce premature growth and breast stimulation in infants, and possibly promote breast cancer in adults."[10]

One of the most dangerous aspects of genetic engineering is the closed thinking and consistent effort to silence those with contrary evidence or concerns. Just before stepping down from office, former Secretary of Agriculture Dan Glickman admitted the following:

"What I saw generically on the pro-biotech side was the attitude that the technology was good, and that it was almost immoral to say that it wasn't good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . And there was a lot of money that had been invested in this, and if you're against it, you're Luddites, you're stupid. That, frankly, was the side our government was on. . . . You felt like you were almost an alien, disloyal, by trying to present an open-minded view"[11]

Contrast this with the warning by the editors of Nature Biotechnology: "The risks in biotechnology are undeniable, and they stem from the unknowable in science and commerce. It is prudent to recognize and address those risks, not compound them by overly optimistic or foolhardy behavior."[12]

In spite of such warnings and the mounting evidence of potential dangers, the FDA claims that GM foods are no different and do not require safety testing. A manufacturer can introduce a GM food without even informing the government or consumers. How could the agency put such a dangerous industry-friendly policy in place, when their own scientists had insisted that each GM variety should be subjected to long-term safety tests before being allowed on the market? One hint was that a former attorney to the biotech giant Monsanto was in charge of FDA policy making. Another hint comes from a memo by former FDA Commissioner David Kessler, who described the agency's policy as "consistent with the general biotechnology policy established by the Office of the President." He said, "It also responds to White House interest in assuring the safe, speedy development of the U.S. biotechnology industry."[13]

Thus, the biotech companies themselves determine if their own foods are safe. While they voluntarily submit studies, according to the Center for Science in the Public Interest, they contain "technical shortcomings in the safety data . . . as well as some obvious errors that the FDA failed to detect."[14] There are also a handful of published industry-sponsored studies. But many scientists describe these as "designed to avoid finding any problems."[15],[16]

Many of the key assumptions used as the basis for industry and government safety claims have been proven wrong or remain untested. Although they continue to promote the myth that GM foods are needed to feed the world, according to the United Nations this is not true.[17] Furthermore, GM crops increase reliance on agricultural chemicals[18] and actually reduce average yields . I encourage you to ignore industry's vacuous claims and review the data for your self. It provides a compelling case why these foods should never have been approved, and why eating them is gambling with your health.[19]

Footnotes:

1, "Expert Panel on the Future of Food Biotechnology," January, 2001, www.rsc.ca/foodbiotechnology/GMreportEN.pdf
2, John Vidal, "GM genes found in human gut," The Guardian, July 17, 2002, www.guardian.co.uk/gmdebate/Story/0,2763,75666 6,00.html
3, "The Impact of Genetic Modification on Agriculture, Food and Health," BRITISH MEDICAL ASSOCIATION, Board of Science and Education, May 1999
4, Stephen R. Padgette and others, "The Composition of Glyphosate-Tolerant Soybean Seeds Is Equivalent to That of Conventional Soybeans," The Journal of Nutrition, vol. 126, no. 4, April 1996 (Also see data taken from the journal archives, as it had been omitted from the published study.)
5, Mark Townsend, "Why soya is a hidden destroyer," Daily Express, March 12, 1999
6, Stephen R. Padgette and others, "The Composition of Glyphosate-Tolerant Soybean Seeds Is Equivalent to That of Conventional Soybeans," The Journal of Nutrition, vol. 126, no. 4, April 1996 (Also see data taken from the journal archives, as it had been omitted from the published study.)
7, S. E. Hankinson, and others, "Circulating concentrations of insulin-like growth factor 1 and risk of breast cancer," Lancet, vol. 351, no. 9113, 1998, pp. 1393-1396
8, June M. Chan and others, "Plasma Insulin-Like Growth Factor-1 [IGF-1] and Prostate Cancer Risk: A Prospective Study," Science, vol. 279, January 23, 1998, pp. 563-566
9, Peter Montague "Milk, rbGH, and Cancer," Rachel's Environment and Health News, no. 593, April 9, 1998
10, "Growth Hormones Would Endanger Milk," Op-ed article, Los Angeles Times, July 27, 1989
11, Bill Lambrecht, Dinner at the New Gene Café, p. 139
12, "Expert Panel on the Future of Food Biotechnology," January, 2001, wwww.rsc.ca/foodbiotechnology/GmreportEN.pdf
13, David Kessler, "FDA Proposed Statement of Policy Clarifying the Regulation of Food Derived from Genetically Modified Plants-DECISION," March 20, 1992, www.biointegrity.org
14, "Plugging The Holes in Biotech Food Safety," Center for Science in the Public Interest, Press Release, January 7 2003 15, Sheldon Rampton and John Stauber, Trust Us We're Experts, Jeremy P. Tarcher/ Putnam, New York, 2001, p154
16, Jeffrey M. Smith, Seeds of Deception, Yes! Books, Fairfield, IA, 2003, pp. 34-38
17, "Expert Panel on the Future of Food Biotechnology," January, 2001, www.rsc.ca/foodbiotechnology/GMreportEN.pdf
18, Charles Benbrook, "Impacts of Genetically Engineered Crops on Pesticide Use: The First Eight Years," BioTech InfoNet Technical Paper Number 6, November 2003, www.biotech-info.net/Technical_ Paper_6.pdf
19, Charles Benbrook, "Evidence of the Magnitude and Consequences of the Roundup Ready Soybean Yield Drag from University-Based Varietal Trials in 1998," Ag BioTech InfoNet Technical Paper Number 1, July 13, 1999, www.biotechinfo.net/RR_yield_drag_98. pdf

© 2004 Jeffrey M. Smith- All Rights Reserved

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After silence, that which comes nearest to expressing the inexpressible is music." - Aldous Huxley

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Eleanore
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posted March 24, 2006 06:24 PM     Click Here to See the Profile for Eleanore     Edit/Delete Message   Reply w/Quote
quote:
Maffei maintained that politicians adopt decisions "without knowing anything about environmental issues," and depend on the advice of specialists who work for private companies that have no interest whatsoever in preserving biodiversity.

Social mobilisation is the only way to break this "vicious cycle of environmental domination," she declared.


I agree. And I think that people in general need to start being more concerned about what they're putting in and on their bodies than, say, what's on tv or whatever. Just my opinion, I know, but there it is. If people were really aware of what's going on I don't think they'd be 100 percent supporting of it. I could go on and on ...
Thanks for this topic.

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"To learn is to live, to study is to grow, and growth is the measurement of life. The mind must be taught to think, the heart to feel, and the hands to labor. When these have been educated to their highest point, then is the time to offer them to the service of their fellowman, not before." - Manly P. Hall

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