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20.07.05, 20:07

By Jeffrey Smith
July 16, 2005

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

5. When all other excuses failed, Monsanto claimed that with such a larg
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    • akserm Ciag dalszy 1 20.07.05, 20:13

      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

      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

      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

      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
      • akserm Re: Ciag dalszy 1 20.07.05, 20:14
        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

        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-fee
        • akserm Re: Ciag dalszy 3 20.07.05, 20:16
          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.

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