The GMO Cover-Up

Agriculture Secretary Tom Vilsack was getting lots of appreciative applause and head nods from the packed hall at the Community Food Security Coalition conference today, held in Des Moines, Iowa. He described the USDA’s plans to improve school nutrition, support local food systems, and work with the Justice Department to review the impact of corporate agribusiness on small farmers. But then, with time for only one more question, I was handed the microphone.

“Mr. Secretary, may I ask a tough question on GMOs?”

He said yes.

“The American Academy of Environmental Medicine this year said that genetically modified foods, according to animal studies, are causally linked to accelerated aging, dysfunctional immune regulation, organ damage, gastrointestinal distress, and immune system damage. A study came out by the Union of Concerned Scientists confirming what we all know, that genetically modified crops, on average, reduce yield. A USDA report from 2006 showed that farmers don’t actually increase income from GMOs, but many actually lose income. And for the last several years, the United States has been forced to spend $3-$5 billion per year to prop up the prices of the GM crops no one wants.
“When you were appointed Secretary of Agriculture, many of our mutual friends—I live in Iowa and was proud to have you as our governor—assured me that you have an open mind and are very reasonable and forward thinking. And so I was very excited that you had taken this position as Secretary of Agriculture. And I’m wondering, have you ever heard this information? Where do you get your information about GMOs? And are you willing to take a delegation in D.C. to give you this hard evidence about how GMOs have actually failed us, that they’ve been put onto the market long before the science is ready, and it’s time to put it back into the laboratory until they’ve done their homework.”

Read entire article here.

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The GE Process

What is a GMO?

A GMO (genetically modified organism) is the result of a laboratory process where genes from the DNA of one species are extracted and artificially forced into the genes of an unrelated plant or animal. The foreign genes may come from bacteria, viruses, insects, animals or even humans. Because this involves the transfer of genes, GMOs are also known as “transgenic” organisms.

This process may be called either Genetic Engineering (GE) or Genetic Modification (GM); they are one and the same.

What is a gene?

Every plant and animal is made of cells, each of which has a center called a nucleus. Inside every nucleus there are strings of DNA, half of which is normally inherited from the mother and half from the father. Short sequences of DNA are called genes. These genes operate in complex networks that are finely regulated to enable the processes of living organisms to happen in the right place and at the right time. 

How is genetic engineering done?

Because living organisms have natural barriers to protect themselves against the introduction of DNA from a different species, genetic engineers must force the DNA from one organism into another. Their methods include:

  • Using viruses or bacteria to “infect” animal or plant cells with the new DNA.
  • Coating DNA onto tiny metal pellets, and firing it with a special gun into the cells.
  • Injecting the new DNA into fertilized eggs with a very fine needle.
  • Using electric shocks to create holes in the membrane covering sperm, and then forcing the new DNA into the sperm through these holes.

Is genetic engineering precise?

The technology of genetic engineering is currently very crude. It is not possible to insert a new gene with any accuracy, and the transfer of new genes can disrupt the finely controlled network of DNA in an organism.

Current understanding of the way in which DNA works is extremely limited, and any change to the DNA of an organism at any point can have side effects that are impossible to predict or control. The new gene could, for example, alter chemical reactions within the cell or disturb cell functions. This could lead to instability, the creation of new toxins or allergens, and changes in nutritional value.

But haven’t growers been grafting trees, breeding animals, and hybridizing seeds for years?

Genetic engineering is completely different from traditional breeding and carries unique risks.

In traditional breeding it is possible to mate a pig with another pig to get a new variety, but is not possible to mate a pig with a potato or a mouse. Even when species that may seem to be closely related do succeed in breeding, the offspring are usually infertile—a horse, for example, can mate with a donkey, but the offspring (a mule) is sterile.

With genetic engineering, scientists can breach species barriers set up by nature. For example, they have spliced fish genes into tomatoes. The results are plants (or animals) with traits that would be virtually impossible to obtain with natural processes, such as crossbreeding or grafting.

What combinations have been tried?

It is now possible for plants to be engineered with genes taken from bacteria, viruses, insects, animals or even humans. Scientists have worked on some interesting combinations:

  • Spider genes were inserted into goat DNA, in hopes that the goat milk would contain spider web protein for use in bulletproof vests.
  • Cow genes turned pigskins into cowhides.
  • Jellyfish genes lit up pigs’ noses in the dark.
  • Artic fish genes gave tomatoes and strawberries tolerance to frost.

Field trials have included:

  • Corn engineered with human genes (Dow)
  • Sugarcane engineered with human genes (Hawaii Agriculture Research Center)
  • Corn engineered with jellyfish genes (Stanford University)
  • Tobacco engineered with lettuce genes (University of Hawaii)
  • Rice engineered with human genes (Applied Phytologics)
  • Corn engineered with hepatitis virus genes (Prodigene)
  • Potatoes that glowed in the dark when they needed watering.
  • Human genes were inserted into corn to produce spermicide.

Does the biotech industry hold any promise?

Genetic modification of plants is not the only biotechnology. The study of DNA does hold promise for many potential applications, including medicine. However, the current technology of GM foods is based on obsolete information and theory, and is prone to dangerous side effects. Economic interests have pushed it onto the market too soon.

Moreover, molecular marker technologies – so called Marker Assisted Selection (MAS) used with conventional breeding – show much promise for developing improved crop varieties, without the potentially dangerous side effects of direct genetic modification.

Source

GMO Trilogy

This explosive exposé reveals what the biotech industry doesn’t want you to know – how industry manipulation and political collusion, not sound science, allow dangerous genetically engineered food into your daily diet. Company research is rigged, alarming evidence of health dangers is covered up, and intense political pressure applied. Chapters read like adventure stories and are hard to put down:

  • Scientists were offered bribes or threatened. Evidence was stolen. Data was omitted or distorted.
  • Government employees who complained were harassed, stripped of responsibilities, or fired.
  • Laboratory rats fed a GM crop developed stomach lesions and seven of the forty died within two weeks. The crop was approved without further tests.
  • The only independent in-depth feeding study ever conducted showed evidence of alarming health dangers. When the scientist tried to alert the public, he lost his job and was silenced with threats of a lawsuit.

Read the actual internal memos by FDA scientists, warning of toxins, allergies, and new diseases – all ignored by their superiors, including a former attorney for Monsanto. Learn why the FDA withheld information from Congress after a genetically modified supplement killed nearly a hundred people and disabled thousands. The GMO Trilogy’s was released in April 2006 in conjunction with Earth Day (April 22) and International GMO opposition Day (April 8)—a coordinated 30-nation campaign to raise awareness about genetically modified (GM) food.

Unnatural Selection (parts 1 – 5)





Hidden Dangers in Kids’ Meals: Genetically Engineered Foods (parts 1-3)



You’re Eating WHAT?

 

Response to “Some truth about GMO” by Mr. Wilmot Simmons

— 04 November 2011 — by Naud Brouwer

Dear Editor,

The use of BT in organic farming is a fact; the thing is that organic farmers have used BT as a pesticide, sprayed on their crops so the UV light from the sun can break it down, and the rain could wash the BT off before any product would be harvested.

Another interesting thing is that the BT used by organic farmers for over 50 years is a weakened or almost dead bacteria. This is only sprayed in case of high insect infestation and only onto the affected area. The bacterium inside the spray contains the pro-form of the so- called BT toxin.

This is not an active component; it needs to be tailored (cut to size) to produce the active BT toxin, which is effective as a pesticide.

When the insect eats the dead bacterium, the toxin is partially digested in the insect gut by proteolytic (cutting) enzymes and converted to active BT toxin. This is actually a lectin which binds to the gut wall of the insects and this interferes with the digestion/absorption of food, thereby preventing growth, maturation, reproduction.

The actual bacterium, which is not eaten by any insects, degrades in the light/sun/rain pretty fast (less than a day). The chances of pests developing resistance to it are very low indeed, since all the pests which are exposed to the toxin are affected by it.

NOTE! The ACTIVE TOXIN can only be found IN THE GUT OF THE INSECT. (Susan Pusztai Bt in organic
farming and GM crops – the difference)

The BT produced by BT corn however, does contain high doses of the active toxin, in the whole plant. The toxin cannot be washed off, or broken down by the sunlight. It stays in the plant after harvesting. The rest material of the plant breaks down, and the BT toxin gets into the ground, and the groundwater. Because of the constant exposure to BT toxin the pests that the farmers want to control develop a resistance to the BT itself, and this means that farmers will have to start spraying even more pesticides than they had to do before with their conventional Hybrid seed.

Is BT corn safe to eat? There has not been any long term testing on humans, so we simply do not know. We do know that:

• BT is extremely similar (so much so it is difficult to distinguish without sophisticated testing) to two other bacteria: B. cereus, which causes food poisoning, and B. anthracis, which causes anthrax.

• BT secretes many of the same toxins B. cereus does when it is growing. There is mounting evidence that spores germinate in humans and can live for extended periods of time in the respiratory and gastrointestinal tract. The effect of these low level infections is unknown, but there have been isolated reports of disease caused by BT. One of the reasons BT may not be seen as a common cause of sickness is that it is very hard to test for its presence – many cases diagnosed as B. cereus gastroenteritis (a fairly common form of food poisoning) may in fact be caused by BT.

• People with sensitive immune systems could be affected in ways we do not yet know, but immune responses are seen when BT infections establish in humans.
• DDT was used for thirty years and was claimed to be extremely safe for humans. The same sort of testing done to arrive at that conclusion has been
done with BT. (Quick Bt Facts)

“Lower crop production”

I am not aware of anyone saying that there will be a lower crop production. But I do know from scientific research that the promised higher yields are not as promising as the big companies tell us.

I would like you to read “failure to yield” written by the Union of Concerned Scientists.

“The U.S. Department of Agriculture data indicate that the average corn production per acre nationwide over the past five years (2004–2008) was about 28 percent higher than for the five-year period 1991–1995, an interval that preceded the introduction of BT varieties.

But our analysis of specific yield studies concludes that only 3–4 percent of that increase is attributable to BT, meaning an increase of about 24–25 percent must be due to other factors such as conventional breeding.”

Failure to yield

Another interesting research on higher yields is a study performed over 30 years.

“Organic farming is far superior to conventional systems when it comes to
building, maintaining and replenishing the health of the soil. For soil health alone, organic agriculture is more sustainable than conventional.

When one also considers yields, economic viability, energy usage, and human health, it’s clear that organic farming is sustainable, while current conventional practices are not.”

FST 30 Years

Since I am writing a letter to the editor of a newspaper and not a book, I have to leave it at this for now. I do want to challenge Mr. Simmons to come up with some unbiased (not paid for by any of the big GMO companies) research about all the issues there are about GMO corn. And I want him to convince me that there is nothing to worry about.

Naud Brouwer
San Miguel, Toledo

 

Genetically modified crops safety assessments: present limits and possible improvements

Gilles-Eric Séralini1*, Robin Mesnage1, Emilie Clair1, Steeve Gress1, Joël S de Vendômois2 and Dominique Cellier3

* Corresponding author: Gilles-Eric Séralini criigen@unicaen.fr

1 Laboratory of Biochemistry – IBFA, University of Caen, Esplanade de la Paix, 14032 Caen, Cedex, France
2 CRIIGEN, Paris, France
3 University of Rouen LITIS EA 4108, 76821 Mont-Saint-Aignan, France

Environmental Sciences Europe 2011, 23:10                                      doi:10.1186/2190-4715-23-10

The electronic version of this article is the complete one and can be found online at: http://www.enveurope.com/content/23/1/10

Received: 17 January 2011
Accepted: 1 March 2011
Published: 1 March 2011

© 2011 Séralini et al; licensee Springer.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

We reviewed 19 studies of mammals fed with commercialized genetically modified soybean and maize which represent, per trait and plant, more than 80% of all environmental genetically modified organisms (GMOs) cultivated on a large scale, after they were modified to tolerate or produce a pesticide. We have also obtained the raw data of 90-day-long rat tests following court actions or official requests. The data obtained include biochemical blood and urine parameters of mammals eating GMOs with numerous organ weights and histopathology findings.

Methods

We have thoroughly reviewed these tests from a statistical and a biological point of view. Some of these tests used controversial protocols which are discussed and statistically significant results that were considered as not being biologically meaningful by regulatory authorities, thus raising the question of their interpretations.

Results

Several convergent data appear to indicate liver and kidney problems as end points of GMO diet effects in the above-mentioned experiments. This was confirmed by our meta-analysis of all the in vivo studies published, which revealed that the kidneys were particularly affected, concentrating 43.5% of all disrupted parameters in males, whereas the liver was more specifically disrupted in females (30.8% of all disrupted parameters).

Conclusions

The 90-day-long tests are insufficient to evaluate chronic toxicity, and the signs highlighted in the kidneys and livers could be the onset of chronic diseases. However, no minimal length for the tests is yet obligatory for any of the GMOs cultivated on a large scale, and this is socially unacceptable in terms of consumer health protection. We are suggesting that the studies should be improved and prolonged, as well as being made compulsory, and that the sexual hormones should be assessed too, and moreover, reproductive and multigenerational studies ought to be conducted too.

Background, aim, and scope

Recently, an ongoing debate on international regulation has been taking place on the capacity to predict and avoid adverse effects on health and the environment for new products and novel food/feed (GMOs, chemicals, pesticides, nanoparticles, etc.). The health risk assessments are often, but not always, based on the study of blood analyses of mammals eating these products in subchronic tests, and more rarely in chronic tests. In particular, in the case of GMOs, the number and nature of parameters assessed, the length of the necessary tests, the statistics used and their interpretations are the subject of controversies, especially in the application of Organization of Economic Cooperation and Development (OECD) norms. Confusion is perceived even in regulatory agencies, as in the European Food Safety Authority (EFSA) GMO panel working group and its guidelines. Doubt has arisen on the role and necessity of animal feeding trials in safety and nutritional assessments of GM plants and derived food and feed [1]. Based on the literature data, EFSA first admitted (p. S33) that for other tests than GMOs: “For 70% (57 of 81) of the studies evaluated, all toxicological findings in the 2-year tests were seen in or predicted by the 3-month subchronic tests”. Moreover, they also indicated (p. S60) that “to detect effects on reproduction or development […] testing of the whole food and feed beyond a 90-day rodent feeding study may be needed.” We fully agree with these assumptions. This is why we think that in order to protect large populations from unintended effects of novel food or feed, imported or cultivated crops on a large scale, chronic 2-year and reproductive and developmental tests are crucial. However, they have never been requested by EFSA for commercial edible crops. We therefore wish to underline that in contrast with the statements of EFSA, all commercialized GMOs have indeed been released without such tests being carried out, and as it was the case recently with maize stacked events without 90-day in vivo mammalian tests being conducted. GM stacked events have the cumulated characteristics of first generation of GMOs (herbicide tolerance and insecticide production), which are mostly obtained by hybridization. For instance, Smarstax maize contains two genes for herbicide tolerance and six genes for insecticide production. In fact, this contradictory possibility was already highlighted in the same review by EFSA (p. S60), when substantial equivalence studies and other analyses were performed: “animal feeding trials with rodents […] adds little if anything […], and is not recommended.” This is why, in this work we will analyze and review deficiencies in GMO safety assessments, not only performed by biotech companies, but also by regulatory agencies.

We will focus on the results of available 90-day feeding trials (or more) with commercialized GMOs, in the light of modern scientific knowledge. We also suggest here an alternative to conventional feeding trials, to understand the biological significance of statistical differences. This approach will make it possible to avoid both false negative and false positive results in order to improve safety assessments of agricultural GMOs before their commercialization for cultivation and food/feed use and imports.

Overview of the safety studies of GMOs performed on mammals

Our experience in scientific committees for the assessment of environmental and health risks of GMOs and in biological, biostatistical research, and medicine, as well as in the research relative to side effects [26] allowed us to review and criticize mammalian feeding trials with GMOs and make new proposals. Mammalian feeding trials have been usually but not always performed for regulatory purposes in order to obtain authorizations or commercialization for GM plant-derived foods or feed. They may have been published in the scientific literature afterwards; however, without public access to the raw data.

We have obtained, following court actions or official requests, the raw data of several 28- or 90-day-long safety tests carried out on rats. The thing we did was to thoroughly review the longest tests from both a biostatistical and a biological point of view. Such studies often analyze the biochemical blood and urine parameters of mammals eating GMOs, together with numerous organ weights and histopathology. We have focused our review on commercialized GMOs which have been cultivated in significant amounts throughout the world since 1994 (Table 1). We observe and emphasize that all the events in Table 1 correspond to soybean and maize which constitute 83% of the commercialized GMOs, whilst other GMOs not displayed in the table, but still commercialized, are canola or cotton. However, they are not usually directly consumed [7]. Only Sakamoto’s and Malatesta’s studies have been more than 90 days long (104 weeks and 240 days with blood analyses in Japanese for the first one). Moreover, such tests are not obligatory yet for all GMOs. No detailed blood analysis is available for Malatesta’s study, as it mostly includes histochemistry at the ultrastructural level; moreover, the latter tests have not been used to obtain the commercial release by the firm. However, this work has been performed by researchers independent from the GMO industry; it is an important element to take into account for an objective interpretation of the facts, as pointed out in the case of the risk assessments conducted by regulatory agencies with Bisphenol A. For instance in the latter case, it was observed that none of the industry-funded studies showed adverse effects of Bisphenol A, whereas 90% of government-funded studies showed hazards at various levels and various doses [8]. However, regulatory agencies still continue to refer only to industry-funded studies because they are supposed to follow OECD norms, even if such standards are not always appropriate for the detection of environmental hazards [9]. In this paper, Myers et al. showed that hundreds of laboratory animals and cell culture studies were rejected by regulatory authorities because they did not follow the Good Laboratory Practices (GLP). The Food and Drug Administration and EFSA have based their final decision on two industry-funded studies, claiming that they were superior to the others because they followed GLP. Yet, GLP are based on ancient paradigms. They have serious conceptual and methodological flaws, and do not take into account the latest knowledge in environmental sciences. For example, in the case of Bisphenol A assessment, the animal models used are known to be insensitive to estrogen (CD-1 mouse). Also, assays and protocols in some OECD guidelines are out of date and insensitive. It is obvious that new product assessments should be based on adapted studies using state-of-the-art experiments. The significant gap between scientific knowledge and regulations should be filled also in the case of GMOs [9]. Therefore, some tests presented here show controversial results or statistically significant results that were not considered as biologically significant by EFSA, raising the question of their interpretation.

Table 1. Review of the longest chronic or subchronic toxicity studies in mammals fed with commercialized GM soybean and maize representing more than 80% of edible GMOs (2010).

First of all, the data indicating no biological significance of statistical effects in comparison to controls have been published mostly by companies from 2004 onwards, and at least 10 years after these GMOs were first commercialized round the world. This is a matter of grave concern. Moreover, only three events were tested for more than 90-days in feeding experiments or on more than one generation. This method was not performed by industries which conducted 90-day tests (with blood and organ analyses), but it was in some cases only. However, a 90-day period is considered as insufficient to evaluate chronic toxicity [1,5]. All these commercialized cultivated GMOs have been modified to contain pesticides, either through herbicide tolerance or by producing insecticides, or both, and could therefore be considered as “pesticide plants.” Almost all GMOs only encode these two traits despite claims of numerous other traits. For instance, Roundup ready crops have been modified in order to become insensitive to glyphosate. This chemical together with adjuvants in formulations constitutes a potent herbicide. It has been used for many years as a weed killer by blocking aromatic amino acid synthesis by inhibition of 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS). Most Roundup ready plants have been modified thanks to the insertion of a mutated EPSPS gene coding for a mutated enzyme, which is not inhibited by glyphosate. Therefore, GM plants exposed to glyphosate-based herbicides such as Roundup do not specifically degrade glyphosate. They can even accumulate Roundup residues throughout their life, even if they excrete most of such residues. Glyphosate and its main metabolite AMPA (with its own toxicity) are found in GMOs on a regular and regulatory basis [10,11]. Therefore, such residues are absorbed by people eating most GM plants (as around 80% of these plants are Roundup tolerant). On the other hand, about 20% of the other GMOs do synthesize new insecticide proteins through the insertion of mutated genes derived from Bacillus thuringiensis (Bt).

Usually, pesticides are tested over a period of 2 years on a mammal, and this quite often highlights side effects. Additionally, unintended effects of the genetic modification itself cannot be excluded, as direct or indirect consequences of insertional mutagenesis, creating possible unintended metabolic effects. For instance, in the MON810 maize, the insertion of the transgene in the ubiquitine ligase gene caused a complex recombination event, leading to the synthesis of new RNA products encoding unknown proteins [12]. Thus, genetic modifications can induce global changes in the genomic, transcriptomic, proteomic, or metabolomic profiles of the host. The frequency of such events in comparison to classical hybridization is by nature unpredictable. In addition, in a plant producing a Cry1Ab-modified toxin, a metabolomic study [13] revealed that the transgene introduced indirectly 50% changes in osmolytes and branched amino acids.

Review of statistical effects after GMO consumption

Some GMOs (Roundup tolerant and MON863) affect the body weight increase at least in one sex [2,14]. It is a parameter considered as a very good predictor of side effects in various organs. Several convergent factors appear to indicate liver and kidney problems as end points of GMO diet effects in these experiments [2,5,15,16]. This was confirmed by our meta-analysis of all in vivo studies published on this particular topic (Table 2). The kidneys are particularly affected, concentrating 42% of all parameters disrupted in males. However, other organs may be affected too, such as the heart and spleen, or blood cells [5].

Table 2. Meta-analysis of statistical differences with appropriate controls in feeding trials

Liver parameters

For one of the longest independent tests performed, a GM herbicide-tolerant soybean available on the market was used to feed mice. It caused the development of irregular hepatocyte nuclei, more nuclear pores, numerous small fibrillar centers, and abundant dense fibrillar components, indicating increased metabolic rates [17]. It was hypothesized that the herbicide residues could be responsible for that because this particular GM plant can absorb the chemicals to which it was rendered tolerant. Such chemicals may be involved in the above-mentioned pathological features. This became even clearer when Roundup residues provoked similar features in rat hepatic cells directly in vitro [18]. The reversibility observed in some instances for these parameters in vivo [19] might be explained by the heterogeneity of the herbicide residues in the feed [20]. Anyway, these are specific parameters of ultrastructural dysfunction, and the relevance is clear. The liver is reacting. The Roundup residues have been also shown to be toxic for human placental, embryonic, and umbilical cord cells [2123]. This was also the case for hepatic human cell lines in a comparable manner, inducing nuclei and membrane changes, apoptosis and necrosis [24].

The other major GMO trait has to do with the mutated (mBt) insecticidal peptidic toxins produced by transgenes in plants. In this case, some studies with maize confirmed histopathological changes in the liver and the kidneys of rats after GM feed consumption. Such changes consist in congestion, cell nucleus border changes, and severe granular degeneration in the liver [16]. Similarly, in the MON810 studies, a significantly lower albumin/globulin ratio indicated a change in hepatic metabolism of 33% of GM-fed male rats (according to EFSA opinion on MON810 and [5]). Taken together, the results indicate potential adverse effects in hepatic metabolism. The insecticide produced by MON810 could also induce liver reactions, like many other pesticides. Of course, the mCry1Ab and other mBt (mutated Bt toxins derived from native Bacillus thuringiensis toxins) in GMOs are proteic toxins; however, these are modified at the level of their amino acid sequence by biotechnologies and introduced by artificial vectors, thus these could be considered as xenobiotics (i.e., a molecule foreign to life). The liver together with the kidneys are the major reactive organs in case of food chronic intoxication.

Kidney parameters

In the NK603 study, statistically significant strong urine ionic disturbances and kidney markers could be explained by renal leakage [5], which is well correlated with the effects of glyphosate-based herbicides (like Roundup) observed on embryonic kidney cells [23]. This does not exclude metabolic effects indirectly due to insertional mutagenesis linked to the plant transformation. Roundup adjuvants even stabilize glyphosate and allow its penetration into cells, which in turn inhibit estrogen synthesis as a side effect, cytochrome P450 aromatase inhibition [21]. This phenomenon changes the androgen/estrogen ratio and may at least, in part, explain differential impacts in both sexes.

Kidney dysfunctions are observed with mBt maize producing mutated insecticides such as in MON863. For instance, we quote the initial EFSA report: “Individual kidney weights of male rats fed with the 33% MON863 diet were statistically significantly lower compared to those of animals on control diets”, “small increases in the incidences of focal inflammation and tubular regenerative changes in the kidneys of 33% MON863 males.” This was confirmed by the company tests [25] and another counter analysis revealed disrupted biochemical markers typical of kidney filtration or function problems [2]. The first effects were not always but sometimes greater than the ones with non-isogenic maize (called reference lines), which contain different salts, lipids, or sugars. Moreover, both results described are different between males and females; this is quite usual in liver or kidney pesticide reactions. These facts do not exclude that such effects can be considered as treatment-related. Other studies also confirmed effects on kidneys. Tubular degeneration and not statistically significant enlargement in parietal layer of Bowman’s capsules were also observed with GM maize fed rats [16].

Last but not least, a total of around 9% of parameters were disrupted in a meta-analysis (Table 2). This is twice as much as what could be obtained by chance only (generally considered as 5%). Surprisingly, 43.5% of significant different parameters were concentrated in male kidneys for all commercialized GMOs, even if only around 25% of the total parameters measured were kidney-related. If the differences had been distributed by chance in the organs, not significantly more than 25% differences would have been found in the kidney. Even if our own counter analysis is removed from the calculation, showing numerous kidney dysfunctions [2], around 32% of disturbances are still noticed in kidneys.

Discussion

Need for chronic tests and other tests

Chronic toxicity tests (both with males and females) and reproductive tests with pregnant females and then with the developing progeny over several generations (none of these steps exist at present) are called as a whole the Toxotest approach (or Risk management test, see “Details on the new suggested Toxotest approach”). This could address the long-term physiological or pathological relevance of the previous observations. The physiological interpretations of 90-day-based effects are otherwise somewhat limited. These studies should be complementary to the present regulations or the Safotest and the sentinel test suggested by EFSA [1]. The Toxotest could provide evidence of carcinogenic, developmental, hormonal, neural, and reproductive potential dysfunctions, as it does for pesticides or drugs. Additionally, it is obvious that the 90-day-long trials on mature animals performed today cannot scientifically replace the sensitivity of developmental tests on neonates. A good example is the gene imprinting by drugs that will be revealed only at maturity; this is an important subject of current research, and many findings have been reported for some chemicals such as bisphenol A [26,27]. Even transgenerational effects occur after epigenetic imprinting by a pesticide [28]. These effects cannot be detected by classical 90-day feeding trials and will be visible after many decades by epidemiology in humans if any, as illustrated in the case of diethylstilbestrol, which induced female genital cancers among other problems in the second generation [29]. The F3 multigenerational study for a GMO (Table 1) was too rarely performed. This is why, because of the number of parameters disrupted in adult mammals within 90 days, the new experiments should be systematically performed to protect the health of billions of people that could consume directly or indirectly these transformed products.

The acute toxicity approach (less than a month of investigations on rodents with high doses) may give effects which are more proportional to the dose, as it might correspond to a rapid poisoning of the animals, generally with force-fed experiments. However, for many pesticide studies in the scientific literature, some long-term side effects of pesticides at environmental doses are described, which are not apparent in short-term experiments [30]. Classical toxicology is quite often based on the concept of revealing linear dose-responses as defined by Paracelsus, which generally fails to evidence U or J curves observed after hormonal sex-specific disruptions. Moreover, the effects of mixtures are also neglected in long-term studies, when supposed active principles of pesticides are not assessed with their adjuvants, which also are present as residues in GMOs. Such pesticides may have the capacity to disrupt the “cell web”, i.e., to interfere with a signaling pathway, and this could be unspecific. For instance Roundup is known to disrupt the EPSPS in plants, but is also known to interact with the mammalian ubiquist reductase [21] common and essential to cytochromes P450, a wide class of detoxification enzymes. The so-called Roundup active principle, glyphosate, acts in combination with adjuvants to increase glyphosate-mediated toxicity[21,31], and this may apply to other environmental pollutants [22]. Moreover, all new metabolites in edible Roundup ready GMOs, as acetyl-glyphosate for the new GAT GMOs, have not been assessed for their chronic toxicity [11], and we consider this as a major oversight in the present regulations.

Therefore, as xenobiotic effects are complex, the determination of their toxic effects cannot be determined using a single method, but rather converging pieces of evidence. In GMO risk assessment, the protocols must be optimized to detect side effects, in particular for herbicide-treated GM plants. These cannot be reduced to GM assessment on one side and herbicide residues with any diet on the other side, but unfortunately this has been the case, and this approach has been promoted up to now by regulatory authorities.

In fact, it is impossible, within only 13 weeks, to conclude about the kind of pathology that could be induced by pesticide GMOs and whether it is a major pathology or a minor one. It is therefore necessary to prolong the tests, as suggested by EFSA, since at least one third of chronic effects visible with chemicals are usually new in comparison to the ones highlighted in subchronic studies [1]. The so-called Toxotests, which are supposed to include the studies of chronic pathologies in particular, should be performed on three mammalian species, with at least one non-rodent, similar to the type of rodents used for pesticides and drugs. However, the chronic feeding tests for GMOs cannot be based on the no observed adverse effect level, nor on the lowest observed adverse effect level approach, as in classical toxicology. There are several reasons for that. There is not only one chemical, but also several unknown metabolites and components, in Roundup tolerant varieties for instance, and therefore toxicity is enhanced thanks to the fact that they are mixed together. There is also no possibility of increasing the doses of GMOs in an equilibrated diet over an acceptable level. The diets should be rather representative of an equilibrated diet with GMOs like it could be the case in a real population in America. To prolong 90-day subchronic tests with three normal doses of GM in the diet (11%, 22%, 33% for instance) is the solution.

Sex- or dose-specific pathological effects are common

When there is a low or environmental dose impregnation of the feed (with a pesticide GM plant for instance), the chronic effects could be more differentiated according to the sex, the physiological status, the age, or the number of intakes over such and such a period of time in the case of a drug. These parameters (chronic intake, age of exposure, etc.) are more decisive for pathologies like cancers, than the actual quantity of toxin ingested in one intake. This is in part because the liver, kidney, and other cytochrome P450-rich organs are concerned for long-term metabolism and detoxification, and this phenomenon is hormone dependent. It is also due to the process of carcinogenesis or hormone-sensitive programming of cells [32]. The liver for instance is a sex differentiated organ as far as its enzymatic equipment is concerned [4]. An effect in subchronic or chronic tests cannot be disregarded on the rationale that it is not linear to the dose (or dose-related) or not comparable in genders. This would not be scientifically acceptable. However, this reasoning was adopted both by companies and EFSA for several GMOs, as underlined by Doull et al. [33]. Indeed, most xenobiotics or pollutants may have non-linear effects, and/or may have sex- and age-specific impacts.

One of the pivotal requirements for regulators nowadays, in order to interpret a significant difference as biologically relevant, is to observe a linear dose-response. This allows them to deduce a causality. However, this dose-response cannot be studied with only two points, which is nonetheless the case for all major commercial GMOs today, which are given in the diet in 11% and 33% concentrations only, in subchronic tests. This is true overall if no preliminary data has been obtained to choose the given doses, which is the case in regulatory files. As we have already emphasized, most of pathological and endocrine effects in environmental health are not directly proportional to the dose, and they have a differential threshold of sensitivity in both sexes [34]. This is, for instance, the case with carcinogenesis and endocrine disruption.

Improving the knowledge on impacts of modified Bt toxins

One of the interpretations of the side effects observed (Tables 1 and 2) would be that the insecticide toxins in maize lines may have more pleiotropic or specific actions than originally supposed. The toxins could generate particular metabolites, either in the GM plant or in the animals fed with it. The Bt toxins in GMOs are new and modified, truncated, or chimerical in order to change their activities/solubility in comparison to wild Bt. For instance, there is at least a 40% difference between the toxin in Bt176 and its wild counterpart [10]. None of the modified Bt toxins have been authorized separately for food or feed, neither has the wild Bt, and neither have they been tested by themselves on animal or human health to date. Even if some studies were performed, the receptors have not been cloned and the signaling pathways have not been identified as yet, nor required for authorizations, and the metabolism of these proteins in mammals are unknown [35]. Thus, the argument about “safe use history” of the wild Bt protein (not designed for direct consumption, in contrast to several GMOs) cannot, on a sound scientific basis, be used for direct authorizations of the above-cited GM corns, overall without in vivo chronic toxicity tests (or Toxotest approach), as it is requested for a pesticide. Some improvements may even be included with regard to pesticide legislation, since these human modified toxins considered as xenobiotics are continuously produced by the plants devoted to consumption.

The proteins usually compared (modified Bt toxins and wild ones) are not identical, and the tests on human cells of Bt proteins are not performed nor are they requested by authorities. Their stability has been assessed in vitro, and GM insecticide toxins are never fully digested in vivo [36]. If some consumers suffer from stomach problems or ulcers, the new toxins will possibly act differently; the digestion in children could be affected too; however, these GMOs could be eaten anywhere and all proteins are never fully decomposed in amino acids by the digestive tract.

Details on the new suggested Toxotest approach

The suggested Toxotest would basically include an extension of the existing 90-day tests, but with at least three doses plus controls (0%, 11%, 22%, 33% GMOs for instance; today the equilibrated diets tested contain 0%, 11%, and 33% GMOs in the best regulatory tests). The purpose would be to characterize scientifically the dose-response approach. The latter cannot be taken seriously with only two GM doses. The final goal is the best health protection for the population without really possible clinical trials, in our case for practical and ethical reasons. There is also no epidemiological follow-up for lack of traceability and labeling in GM-producing American countries. In addition, the fact that the Toxotest includes the best possible toxicological approach will also be in favor of the biotechnology economy and the European Community because it is more expensive to address an issue concerning a whole population afterwards, rather than to work with laboratory animals beforehand; it is also more ethical to work on rats and other mammalian experiments, in order to get the relevant information, rather than to give pesticide plants directly to humans on a long-term basis.

As previously underlined, the health effects such as those suggested in Table 2 (if any, are revealed by adapted studies, such as Safotests or Toxotests), could only be due to two possibilities:

Firstly, the side effects may be directly or indirectly due to a pesticide residue and/or its metabolites. The direct effect is about the pesticide effect on the consumer, and the indirect one is about a metabolism disruption that it has provoked within the plant first. This could not be visible by a detailed compositional analysis, such as the one performed to be assessed by a substantial equivalence study. This concept is not a well-defined one (how many cultivations of crops, over how many years, under which climate, and to measure what precise parameters).

Secondly, the pathological signs may be due to the genetic transformation itself, its method provoking either insertional mutagenesis or a new metabolism by genetic interference. This is the reason why separating intended effects (the direct genetic trait consequence itself) from unintended effects (linked to biotechnology, e.g., insertional mutagenesis), such as spiking the control diet with the purified toxin in the Toxotest approach, is clearly inadequate. It could work in the case of a direct action of the toxin in mammals, but conversely one could not conclude, between an insertional mutagenesis and a specific metabolic action in the plant due to the toxin. However, this is more a research question about the mode of genesis of an effect on health, and new research avenues could be, for instance, to compare the GM diet with or without herbicide treatment in long-term tests with the isogenic control diet including herbicide residues added. This is only necessary for the understanding of the potential signs of toxicity and not for a conclusion of the Safotest or the Toxotest, which would rather suggest, if positive, excluding immediately the corresponding GMO from food and feed.

Improvement of statistical analysis

A serious experimental design is based on a proper choice of the groups, with only one question studied per experiment if possible, and balanced sample sizes. In several authorized GMOs, the sample sizes appear inadequate in 90 days: ten animals per group for the measurement of biochemical parameters out of 20, as performed by the major stakeholders, and accepted by EFSA for MON863, MON810, or NK603 for instance. This is too limited a size to ensure that parametric statistical methods used by the company are reliable. Moreover, an important discrepancy between GMO-treated rats (40 measured out of 80) and the total number of animals (400) renders more difficult the evidencing of relevant effects, and confusion factors are brought in at the same time with six different reference diets in addition to the two normal control groups as performed in three commercialized GMOs at least [5,6]. This introduces new uncontrolled sources of variability about the effects of the diets and new unnecessary questions not relevant to the GMO safety. The representation of a standard diet with multiple sources could have been studied with only one control group of the same size than the GMO group, eating a mix of six different regular non-GM diets.

Several questions have been raised by companies and authorities as well as comments on statistically significant effects that would supposedly not be biologically meaningful. A subjective part is introduced at this level because it is necessary to take into account the context and the general and detailed knowledge of toxicology and endocrine disruption, as EFSA underlines. This might be highly expert dependent. This is why, to avoid or prevent any misunderstanding, we suggest, in addition to a new statistical approach based on classical methods, to analyze the 90-day tests, even with control and reference diets called the “SSC method” (according to the initials of the authors in [2]).

Briefly, following the necessity to model and analyze the growth curves, multivariate data analysis and data mining of all parameters can be used to correlate, cluster, and select meaningful variables. This kind of approach is not performed at all today. Thereafter, the detailed comparison between GM-treated and control groups, fed with the near isogenic line (because the real isogenic line does not often exists anymore), will necessarily be followed by the study of specific diet effects, when there are non-substantially equivalent diets for reference groups. For that purpose, the controls will be first compared using multivariate inference with reference groups, and thereafter, similarly GMO-treated groups with reference groups. The significant differences linked to the GMO and/or the composition of the diet will be classified according to organ and function. The results will appear more clearly than with the simple statistics accepted today by the authorities (that is, comparison of the highest GM dose group with the mean value of all six control groups), and will reveal in addition new information, as it can be demonstrated.

As recommended by EFSA, an appropriate and relevant statistical analysis is crucial. It should follow the following series of steps, allowing the use of several methods depending on the questions raised:

• Obtaining and modeling the growth curves and feed consumption, assessed by non-linear regression, validation, and statistical comparisons in order to test if the curves are significantly different, thus taking into account individual variability. This necessitates the use of time series analysis, selection models, and non-parametric tests, Akaike Information Criteria and related methods. Water consumption should also be an important factor to follow-up and therefore better understand kidney and urine data.

• The study of dose-response predictions using non-linear regression should be the goal, but the only two doses generally used in these tests do not make it possible to evidence linearity as we indicated. Moreover, in the cases where there are not dose-related trends or relationships using the two doses mentioned, the absence of linear dose-response curves cannot be a reason to neglect the effects. For instance, as previously cited, U or J curves may be characteristic of endocrine effects [37], and spiky irregular curves may be detected in carcinogenesis.

• Simultaneous analysis of all observed variables: multivariate data analysis, principal component analysis, correlations analysis, factorial analysis and clustering

• Multivariate comparisons of the different variables: hypothesis testing, multiple ways ANOVA, MANOVA, and others to determinate if the groups differ relative to the different questions: specific GMO effect or diet effect per se. To evidence a detail, when comparing two mean values, SEM should be calculated to determine confidence intervals; however, SD have been used up to now by the company for MON863 and NK603 files for instance.

Apart from empirical curves in some instances, ANOVA and univariate hypothesis testing only the GMO effect, none of the other statistical approaches is currently used nor requested by the authorities.

Human tests and post-market monitoring

For the record, it must be said that very few tests on humans have been carried out up to now. Moreover, epidemiological studies are not feasible in America, since there is no organized traceability of GMOs anywhere on the continent, where, by far, most of edible GMOs are cultivated (97%). As a consequence, a post-market monitoring (PMM) is offered to the population. The Cartagena Biosafety Protocol identifying GMOs at the borders of a country has now been signed by over 150 countries, including the member states of the European Union. PMM may have some value in detecting unexpected adverse effects. It could therefore be considered as a routine need. This approach makes it possible to collect information related to risk management. It can be relied upon as a technique for monitoring adverse events or other health outcomes related to the consumption of GM plant-derived foods, provided that the Toxotest approach, together with the SSC method, should have already been applied. The PMM should be linked with the possibility of detecting allergenicity reactions to GMOs in routine medicine, thanks to the very same routine cutaneous tests that should be developed prior to large-scale commercialization. A screening of serum banks of patients with allergies could be also put forward in order to search for antibodies against the main GMOs and not only their transgenic proteins, since they may induce secondary allergenic metabolites in the plant not visible in the substantial equivalence study.

The traceability of products from animals fed on GMOs is also crucial. The reason for this is because they can develop chronic diseases which are not utterly known today. Such possible diseases could be linked to the hepatorenal toxicity observed in some GMO-related cases (Table 1).

Moreover, labeling animals fed on GMOs is therefore necessary because some pesticide residues linked to GMOs could pass into the food chain and also because nobody would want to eat disabled or physiologically modified animals after long-term GMOs ingestion, even if pesticides residues or DNA fragments are not toxic nor transmitted by themselves.

Conclusion

Transcriptomics, proteomics and other related methods are not ready yet for routine use in the laboratories, and moreover they may be inappropriate for studying toxicity in animals, and could not in any way replace in vivo studies with all the physiological and biochemical parameters that are measured with organs weight, appearance, and histology. By contrast, afterwards, new approaches could well help to explain pathological results or action mechanisms of pesticides present in the GM plants or GM-fed animals, if found.

To obtain the transparency of raw data (including rat blood analyses) for toxicological tests, maintained illegally confidential, is crucial. It has also become crucial to apply objective criteria of interpretation like the criteria described here: sex-specific side effects or non-linear ones. Such data can be put online on the EFSA website with a view to provide a fuller review to the wider scientific community, and in order to better inform the citizen to make biotechnologies more socially acceptable. Since fundamental research is published on a regular basis, it should be the same for this kind of applied research on long-term health effects, as suggested by the CE/2001/18 and the corresponding 1829/2003 regulations.

We can conclude, from the regulatory tests performed today, that it is unacceptable to submit 500 million Europeans and several billions of consumers worldwide to the new pesticide GM-derived foods or feed, this being done without more controls (if any) than the only 3-month-long toxicological tests and using only one mammalian species, especially since there is growing evidence of concern (Tables 1 and 2). This is why we propose to improve the protocol of the 90-day studies to 2-year studies with mature rats, using the Toxotest approach, which should be rendered obligatory, and including sexual hormones assessment too. The reproductive, developmental, and transgenerational studies should also be performed. The new SSC statistical method of analysis is proposed in addition. This should not be optional if the plant is designed to contain a pesticide (as it is the case for more than 99% of cultivated commercialized GMOs), whilst for others, depending on the inserted trait, a case-by-case approach in the method to study toxicity will be necessary.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

GES designed and coordinated the review. RM participated in the drafting of the manuscript and final version. EC, SG, JSV and DC helped the writing, compiling the literature, revising in details and proofreading the manuscript. All authors read and approved the final manuscript.

Acknowledgements

We thank the CRIIGEN scientific committee for helpful discussions and structural support, as well as the Risk Pole (MRSH-CNRS, University of Caen, France). We acknowledge the French Ministry of Research for financial support and the Regional Council of Basse-Normandie. We are grateful to Herrade Hemmerdinger for the English revision of this manuscript.

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The ‘Monsanto Rider’: Are Biotech Companies About to Gain Immunity from Federal Law?

The Secretary of Agriculture would be required to grant a permit for the planting or cultivation of a genetically engineered crop, regardless of environmental impact.
July 6, 2012 | While many Americans were firing up barbecues and breaking out the sparklers to celebrate Independence Day, biotech industry executives were more likely chilling champagne to celebrate another kind of independence: immunity from federal law.

A so-called “Monsanto rider,” quietly slipped into the multi-billion dollar FY 2013 Agricultural Appropriations bill, would require – not just allow, but require – the Secretary of Agriculture to grant a temporary permit for the planting or cultivation of a genetically engineered crop, even if a federal court has ordered the planting be halted until an Environmental Impact Statement is completed. All the farmer or the biotech producer has to do is ask, and the questionable crops could be released into the environment where they could potentially contaminate conventional or organic crops and, ultimately, the nation’s food supply.

Unless the Senate or a citizen’s army of farmers and consumers can stop them, the House of Representatives is likely to ram this dangerous rider through any day now.

In a statement issued last month, the Center For Food Safety had this to say about the biotech industry’s latest attempt to circumvent legal and regulatory safeguards:

Ceding broad and unprecedented powers to industry, the rider poses a direct threat to the authority of U.S. courts, jettisons the U.S. Department of Agriculture’s (USDA) established oversight powers on key agriculture issues and puts the nation’s farmers and food supply at risk.

In other words, if this single line in the 90-page Agricultural Appropriations bill slips through, it’s Independence Day for the biotech industry.

Rep. Peter DeFazio (D-Ore.) has sponsored an amendment to kill the rider, whose official name is “the farmers assurance” provision. But even if DeFazio’s amendment makes it through the House vote, it still has to survive the Senate. Meanwhile, organizations like the Organic Consumers Association, Center for Food Safety, FoodDemocracyNow!, the Alliance for Natural Health USA and many others are gathering hundreds of thousands of signatures in protest of the rider, and in support of DeFazio’s amendment.

Will Congress do the right thing and keep what are arguably already-weak safeguards in place, to protect farmers and the environment? Or will industry win yet another fight in the battle to exert total control over our farms and food supply?

Biotech’s ‘Legislator of the Year’ behind the latest sneak attack

Whom do we have to thank for this sneak attack on USDA safeguards? The agricultural sub-committee chair Jack Kingston (R-Ga.) – who not coincidentally was voted “legislator of the year for 2011-2012” by none other than the Biotechnology Industry Organization, whose members include Monsanto and DuPont. As reported by Mother Jones, the Biotechnology Industry Organization declared Kingston a “champion of America’s biotechnology industry” who has “helped to protect funding for programs essential to the survival of biotechnology companies across the United States.”

Kingston clearly isn’t interested in the survival of America’s farmers.

Aiding and abetting Kingston is John C. Greenwood, former US Congressman from Pennsylvania and now president of the Biotechnology Industry Organization. No stranger to the inner workings of Congress, Greenwood lobbied for the “farmers assurance provision” in a June 13 letter to Congress, according to Mother Jones and Bloomberg, claiming that “a stream of lawsuits” have slowed approvals and “created uncertainties” for companies developing GE crops.

Greenwood was no doubt referring to several past lawsuits, including one brought in 2007 by the Center for Food safety challenging the legality of the USDA’s approval of Monsanto’s Roundup Ready alfalfa. In that case, a federal court ruled that the USDA’s approval of GMO alfalfa violated environmental laws by failing to analyze risks such as the contamination of conventional and organic alfalfa, the evolution of glyphosate-resistant weeds, and increased use of Roundup. The USDA was forced to undertake a four-year study of GMO alfalfa’s impacts under the National Environmental Policy Act (NEPA). During the four-year study, farmers were banned from planting or selling the crop – creating that ‘uncertainty” that Greenwood is so worried about.

The USDA study slowed down the release of GMO alfalfa, but ultimately couldn’t stop it. As Mother Jones reports, in 2011, the USDA deregulated the crop, even though according to its own study, the USDA said that “gene flow” between GM and non-GM alfalfa is “probable,” and threatens organic dairy producers and other users of non-GMO alfalfa, and that there is strong potential for the creation of Roundup-resistant “superweeds” that require ever-higher doses of Roundup and application of ever-more toxic herbicides. The report noted that two million acres of US farmland already harbor Roundup-resistant weeds caused by other Roundup Ready crops.

In another case – which perhaps paved the way for this latest provision now before the House – the USDA in 2011 outright defied a federal judge’s order to halt the planting of Monsanto’s controversial Roundup-Ready GMO sugar beets until it completed an Environmental Impact Statement. The USDA allowed farmers to continue planting the crop even while it was being assessed for safety on the grounds that there were no longer enough non-GMO seeds available to plant.

Who loses if Monsanto wins this one?

Among the biggest losers if Congress ignores the DeFazio amendment and passes the “farmers assurance provision” are thousands of farmers of conventional and organic crops, including those who rely on the export market for their livelihoods. An increasing number of global markets are requiring GMO-free agricultural products or, at the very least, enforcing strict GMO labeling laws. If this provision passes, it will allow unrestricted planting of potentially dangerous crops, exposing other safe and non-GMO crops to risk of contamination.

As we’ve seen in the past, farmers who grow crops that have been inadequately tested and later found dangerous, or whose safe crops become contaminated by nearby unsafe crops, risk huge losses and potentially, lawsuits from their customers. Ultimately, the entire US agriculture market and US economy suffers.

We have only to look back to the StarLink corn and LibertyLink rice contamination episodes for evidence of how misguided this provision is. In October 2000, traces of an Aventis GM corn called StarLink showed up in taco shells in the U.S. even though the corn had not been approved for human consumption because leading allergists were concerned it would cause food allergies. The contamination led to a massive billion dollar recall of over 300 food brands. The ‘StarLink’ gene also turned up unexpectedly in a second company’s corn and in US corn exports, causing a costly disruption to the nation’s grain-handling system, and spurring lawsuits by farmers whose crops were damaged.

A similar disaster occurred for US rice farmers in 2006. In august of that year the USDA announced that mutant DNA of Liberty Link, a genetically modified variety of rice developed by Bayer CropScience, a then-German agri-business giant, were found in commercially-grown long-grain rice in Arkansas, Louisiana, Mississippi, Texas and Missouri. LibertyLink rice, named for Bayer’s broad-spectrum herbicide glufosinate-ammonium, was never intended for human consumption. Following the announcement of contamination, Japan banned all long-grain rice imports from the U.S., and U.S. trade with the EU and other countries ground to a halt. Rice farmers and cooperatives were forced to engage in five long years of litigation against Bayer

CropScience in an attempt to recoup some of their losses.

All the other ways this provision is just plain bad

There’s a reason we have laws like the National Environmental Policy Act (NEPA) and the Plant Protection Act of 2000, which was specifically designed “to strengthen the safety net for agricultural producers by providing greater access to more affordable risk management tools and improved protection from production and income loss . . .”. The ‘farmers assurance provision” is a thinly disguised attempt by the biotech industry to undermine these protections. Worse yet, it’s an affront to everyone who believes the US judicial system exists to protect US citizens and public health.

Why should you be outraged about this provision? For all these reasons:

  • The Monsanto Rider is an unconstitutional violation of the separation of powers. Judicial review is an essential element of U.S. law, providing a critical and impartial check on government decisions that may negatively impact human health, the environment or livelihoods. Maintaining the clear-cut boundary of a Constitutionally-guaranteed separation of powers is essential to our government. This provision will blur that line.
  • Judicial review is a gateway, not a roadblock. Congress should be fully supportive of our nation’s independent judiciary. The ability of courts to review, evaluate and judge an issue that impacts public and environmental health is a strength, not a weakness, of our system. The loss of this fundamental safeguard could leave public health, the environment and livelihoods at risk.
  • It removes the “legal brakes” that prevent fraud and abuse. In recent years, federal courts have ruled that several USDA GE crop approvals violated the law and required further study of their health and environmental impact. These judgments indicated that continued planting would cause harm to the environment and/or farmers and ordered interim planting restrictions pending further USDA analysis and consideration. The Monsanto rider would prevent a federal court from putting in place court-ordered restrictions, even if the approval were fraudulent or involved bribery.
  • It’s unnecessary and duplicative. Every court dealing with these issues is supposed to carefully weigh the interests of all affected farmers and consumers, as is already required by law. No farmer has ever had his or her crops destroyed as a result. USDA already has working mechanisms in place to allow partial approvals, and the Department has used them, making this provision completely unnecessary.
  • It shuts out the USDA. The rider would not merely allow, it would compel the Secretary of Agriculture to immediately grant any requests for permits to allow continued planting and commercialization of an unlawfully approved GE crop. With this provision in place, USDA may not be able to prevent costly contamination episodes like Starlink or Liberty Link rice, which have already cost farmers hundreds of millions of dollars in losses. The rider would also make a mockery of USDA’s legally mandated review, transforming it into a ‘rubber stamp’ approval process.
  • It’s a back-door amendment of a statute. This rider, quietly tacked onto an appropriations bill, is in effect a substantial amendment to USDA’s governing statute for GE crops, the Plant Protection Act. If Congress feels the law needs to be changed, it should be done in a transparent manner by holding hearings, soliciting expert testimony and including full opportunity for public debate.

If we allow this “Monsanto Rider” to be slipped into the FY 2013 Agricultural Appropriations bill, consumers and farmers will lose what little control we have now over what we plant and what we eat.

If you would like to join the hundreds of thousands of concerned citizens who have already written to Congress in support of the DeFazio amendment, please sign our petition here.


Alexis Baden-Mayer is Political Director of the Organic Consumers Association.

Ronnie Cummins is founder and director of the Organic Consumers Association. Cummins is author of numerous articles and books, including “Genetically Engineered Food: A Self-Defense Guide for Consumers” (Second Revised Edition Marlowe & Company 2004).

Original Article

Class Action – 60 farmers sue Monsanto over GMO seed patents

Farm to consumer legal defense fund in Suit over Monsanto GMO Seed

Falls Church, Virginia (April 13, 2011) – On behalf of 60 family farmers, seed businesses and organic agricultural organizations, the Public Patent Foundation (PUBPAT) filed suit on March 29 against Monsanto Company to challenge the chemical giant’s patents on genetically modified seed. The organic plaintiffs were forced to sue preemptively to protect themselves from being accused of patent infringement should they ever become contaminated by Monsanto’s genetically modified seed, something Monsanto has done to others in the past.

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