How Safe is Your Food?

May 19, 2009

How safe is your food?

How safe is your food?

By Dr. Dan

Many people raise some good questions about food safety, ones well worthy of discussion. One prime topic is food safety.

Monsanto has legal, ethical and moral responsibility for its products. The problem with all moral precepts, however, comes when the proverbial rubber meets the road–how does one implement one’s moral responsibilities and, given that one can always consider doing more, how does one know when one has been sufficiently diligent?

But here’s a mindblower. Food is not absolutely safe–it never was and it never will be. We KNOW that food consumption has consequences for long term cardiovascular health, diabetes, etc.  Some foods may even have acute health effects–everything from glutin enteropathy (Celiac disease) to food allergies.  To date, there is no evidence that GM technology has injured anyone. Peanuts kill about 70 Americans every year, and we know that early introduction of peanuts in the diet increases risks of sensitization.

Dr. Ames, creator of the Ames test for cancer causing chemicals, has himself pointed out that most of the cancer-causing chemicals in foods are natural. Despite this, I am not aware of a single food that has ever had long term human or even animal SAFETY testing.  (I emphasize safety testing – people have tried to study food intake for certain beneficial effects – but these are not safety assessment studies.)

By the way–I eat peanut butter, and I feed my kids peanut butter!

Given that we cannot ever demonstrate absolute safety, how do we know, in the real practical world, when we have done enough?  How do we know when we have demonstrated that our products are, at a minimum, AS SAFE AS existing foodstuffs? This is the regulatory standard, and I believe our moral one as well. If we can actually make food SAFER that is great–and I would argue that this may be possible–but we should be held to the same standard as any other purveyor of foods.

  1. We DO look very specifically for toxicity in acute (single high dose) and subacute (28 day) studies at maximally tolerated doses (you can only feed so much corn to rat) to look for toxicity.
  2. Scientific research finds no such relationship exists.

On the issue of testing for unknown toxins, some of the blog readers have asked for chemical analysis–but how would this be done? There is no test for everything. To look for something you have to know what you are looking for, and to quantify it you need an analytical standard for comparison. You cannot test analytically for the complete unknown.  What CAN be done is to look for unanticipated toxins NON-analytically–give the food to animals at a high dose and look for toxic effects. Instead of looking for the toxin, look for the toxicity–and this is EXACTLY what we do.

The issue of long term human testing for health effects is complex. In the laboratory or supervised settings, how would this be done?

Take 100 people and make 50 of them eat, as a large part of their diet, only GM corn or GM soybeans, and keep the rest of their diet standardized so that the groups were comparable. Do this for 30 years, 70 years.

Realistically, this type of human testing cannot be done for any kind of product.  Epidemiologically, if you compare Europe and the U.S., you will find many differences in diet (and in fact the European diet includes GM–they do not grow much, but they import a lot) and many differences in the rates of various diseases and conditions.

This is all well and good, but how do you actually attribute cause and effect in such a study?  This has been done in some cases looking for specific benefits (omega-3 fats and heart disease)), but how do you gain an understanding when you want to look for everything?  You will find thousands of dietary differences and thousands of differences in health and wellbeing, but how do you know what CAUSES what?

I am afraid that what we are confronted with is not corporate ineptitude or lack of interest, but the fundamental epistemological limits to human knowledge. It is disturbing to confront this as a human, and even more so as a parent. I do not say any of this to excuse us from doing our job–only to point out that we confront the same limits to knowability as the rest of humanity.  Given that virtually no other food is tested, and given what we know about our products, we endeavor to do a thorough battery of testing.

Dan is the Director of Medical Sciences and Outreach at Monsanto. He is a pediatrician, medical toxicologist, and clinical pharmacologist by training, and for the past 10 years his role at Monsanto has been devoted on human safety and health, with a focus on communications with the general public and with physicians, nutritionists, and other scientists both in the US and around the world. Dan received his undergraduate degree in Molecular Biology from the University of Wisconsin in 1976 and my MD degree from Johns Hopkins in 1981, followed by a residency in Pediatrics at Johns Hopkins and a fellowship in Clinical Pharmacology and Medical Toxicology at the University of Toronto. He is board certified by the American Boards of Pediatrics, Medical Toxicology, and Clinical Pharmacology, and by the Royal College of Physicians of Canada (Pediatrics).

Prior to Monsanto, Dan spent 10 years in private practice in Denver, Colorado, providing consultation in the area of Clinical, Occupational, Environmental and Forensic Toxicology. He joined Monsanto’s Medical Department in 1998, was appointed a Senior Science Fellow in 2002, and currently serves as Director of Medical Sciences and Outreach within Regulatory Affairs.  Dr. Dan has been extensively involved in plant biotechnology, pesticide, and children’s environmental health issues, and  served on the U.S. EPA’s Child Health Protection Advisory Committee, as a member of the EPA Science Advisory Board regarding the cancer risk assessment from early-life exposure to carcinogens, as an advisor to the NAFTA Commission for Environmental Cooperation regarding the development of international child health indicators, and as well as Board member for the American College of Medical Toxicology.

Dan is married, with four children, and lives in suburban St. Louis, Missouri. In addition to personal interests in carpentry and other do-it-yourself activities, digital photography, and collecting apothecary glass, he is currently writing a compendium of apothecary and pharmaceutical terminology spanning the time frame from colonial America through to the era of modern therapeutics circa 1930.

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45 Responses to “How Safe is Your Food?”

  1. Deborah Rubin Says:

    Dr. Dan, I wonder if you would speak to the specific concerns and studies cited by the American Academy of Environmental Medicine.

    http://www.aaemonline.org/gmopost.html

    However, several animal studies indicate serious health risks associated with GM food consumption including infertility, immune dysregulation, accelerated aging, dysregulation of genes associated with cholesterol synthesis, insulin regulation, cell signaling, and protein formation, and changes in the liver, kidney, spleen and gastrointestinal system.

    There is more than a casual association between GM foods and adverse health effects. There is causation as defined by Hill’s Criteria in the areas of strength of association, consistency, specificity, biological gradient, and biological plausibility.5 The strength of association and consistency between GM foods and disease is confirmed in several animal studies.2,6,7,8,9,10,11

    Specificity of the association of GM foods and specific disease processes is also supported. Multiple animal studies show significant immune dysregulation, including upregulation of cytokines associated with asthma, allergy, and inflammation. 6,11 Animal studies also show altered structure and function of the liver, including altered lipid and carbohydrate metabolism as well as cellular changes that could lead to accelerated aging and possibly lead to the accumulation of reactive oxygen species (ROS). 7,8,10 Changes in the kidney, pancreas and spleen have also been documented. 6,8,10 A recent 2008 study links GM corn with infertility, showing a significant decrease in offspring over time and significantly lower litter weight in mice fed GM corn.8 This study also found that over 400 genes were found to be expressed differently in the mice fed GM corn. These are genes known to control protein synthesis and modification, cell signaling, cholesterol synthesis, and insulin regulation. Studies also show intestinal damage in animals fed GM foods, including proliferative cell growth9 and disruption of the intestinal immune system.6

    Regarding biological gradient, one study, done by Kroghsbo, et al., has shown that rats fed transgenic Bt rice trended to a dose related response for Bt specific IgA. 11

    With the precautionary principle in mind, because GM foods have not been properly tested for human consumption, and because there is ample evidence of probable harm, the AAEM asks:

    Physicians to educate their patients, the medical community, and the public to avoid GM foods when possible and provide educational materials concerning GM foods and health risks.

    Physicians to consider the possible role of GM foods in the disease processes of the patients they treat and to document any changes in patient health when changing from GM food to non-GM food.

    Our members, the medical community, and the independent scientific community to gather case studies potentially related to GM food consumption and health effects, begin epidemiological research to investigate the role of GM foods on human health, and conduct safe methods of determining the effect of GM foods on human health.

    For a moratorium on GM food, implementation of immediate long term independent safety testing, and labeling of GM foods, which is necessary for the health and safety of consumers.

  2. John Q Says:

    I think you meant:

    With the precautionary principle in mind, because NO foods have been properly tested for human consumption….

    Because according to Dr. Dan,

    “Despite this, I am not aware of a single food that has ever had long term human or even animal SAFETY testing. (I emphasize safety testing – people have tried to study food intake for certain beneficial effects – but these are not safety assessment studies.)”

    So, should we stop eating altogether, or should we just wait twice as long to complete GM food testing, because we have to establish a baseline by testing the Non-GM versions first?

    What do we do if we find the Non-GM food to be unsafe? I guess we still have to test the GM food, because the GM may well render it safe(r).

    What level of safety do we need? And how do we define that? Because salt and nitrate curing used to be REQUIRED to make some food safe to store, and people died of other causes before the salt and/or nitrate because a health issue.

    What year/technology level do we use for this baseline? What culture? Some cultures have more access to refrigeration, for example, than others.

    What about preservatives? Many of them have estrogen-like properties that could muddy the results. Some cultures allow alcohol consumption in moderation, while others don’t. This could affect the study. Could it be that because oif chemical interactions GM foods fall within the safety margins for moderate alcohol consumers, but not for abstainers? (or make it the other way, if you’d rather. It makes no difference.)

    Will these long term studies be carried out on animals only? Because there is no perfect animal analog to humans. Or will you ask humans to volunteer for this study? Lab rats have generations every month or so, so it is easy to do a 4-generation study in less than a year. Are you willing to wait 100 years for a 4-generation human study? What about all of the people that potentially will starve to death in that century? Is it, “Too bad, this food MAY be unsafe”?

    Sorry, I don’t mean to badger you. Sincerely. I’m just trying to get a handle on what you are REALLY asking for. Because what I am READING you asking for (and I admit the failure may be in my reading) sounds not only impractical, but nigh impossible to accomplish.

    Because humans (not you, perhaps) HAVE been eating GM foods for over a decade, as have farm animals by the millions, and there has not been a SINGLE documented case of illness attributable to GM.

    So let me drop back to a single question. You ask for “implementation of immediate long term independent safety testing”. If a decade isn’t long enough, then what is?

  3. David Says:

    Sorry, I didn’t hear a direct answer to the question, “How Safe Is Your Food?”

    If I’m getting the gist of what you’re saying here, it is that Monsanto feels it’s products are minimally safe–at least as much as other foods on the market–and that’s as good as you can get it because of the fundamental epistemological limits to human knowledge. Is that correct?

    Do you feel personally that there is any possibility of GM foods (and the use of pesticides) being detrimental in any way for humans or for the environment?

    Thank you,
    David

  4. Dan Goldstein Says:

    I think Deborah’s response belies serious confusion rather than material disagreement.

    The American Academy of Environmental Medicine is an organization of Clinical Ecologists and other individuals with viewpoints which can best be characterized as being well away from the medical and scientific mainstream. The authoratative organization in this area is the American College of Occupational and Environmental Medicine (ACOEM, of which I am a member). Without wishing to get into the power struggle between these organizations and the far broader battles of what constitutes a legitimate medical sub-specialty, I do not believe that a statement from the American Academy of Environmental Medicine raises any credible concern in this area.

    Rebuttals for the various cited studies are readily available, a number of them on our For the Record website.

    More to the point, the criteria put forth by Sir Austin Bradford-Hill (which I use and which I have taught on numerous occasions) are intended to apply to the interpretation of epidemiologic studies. While a number of these criteria do depend on animal or other data for support, I am not aware of a single epidemiological study in this area to which the Hill Criteria can be properly (or for that matter, improperly!) appied.

    The various “all over the map” effects alleged in the various studies noted (the reference numbers are not in reference a provided bibliography) are exactly the kind of LACK of specificity of effect that raise serious questions about the specificity and biological plausibility under the Hill Criteria- assuming one did have an epidemiological study to apply them to.

    A number of your other responses have certainly been both to the point and worthy of serious discussion. I am afraid this one is just misguided.

  5. Deborah Rubin Says:

    John Q, are you asking me a question? I’m not sure I understand as I am asking Dr. Dan to respond to the comments and concerns of the AAEM. This position was written by AAEM, not me.

    There has been no decade long-term independent safety testing that I am aware of. People smoke for 10 years, do drugs, get exposed to pesticides, low levels of radiations, etc, with no apparent health consequences. But that does not prove safety. That is not a study.

  6. Larry Kenchel Says:

    But Debborah, using that logic, the I think John Q is right, we have to stop eating all cooked or prepared food. There have been no studies done that demonstrate the chemical reactions that create to demonstrate no health consequenses. Do you really want restaurants to have to go through a formal safety study before they introduce a menu item? because that particular combination of ingediants and preparartion method has never been tested. That seems rather impractical to me.

  7. Ewan Ross Says:

    I think this discussion also poses the question as to how far out of left field can comments and concerns come and still be taken seriously, as Dan mentions – the studies cited in the AAEM statment have either been covered already elsewhere (at a guess most of them in conversations on this blog already without even having to check out ‘for the record’ or the wider world), the AAEM is not exactly what you’d classify as a great source for scientific info (not that UCS etc can be either really, but at least they almost try)-(with links to Complementary, Alternative, Integrative, Holistic & Funcational Medicine (read psuedo-science – any ‘alternative’ or ‘complementary’ medicine which actually works (ie in a double blind scientific trial) can safely just call itself ‘medicine’))

    In terms of smoking, drugs, pesticides, radiation etc there are methods by which science can predict, based on animal models, whether there are potential long term effects without conducting 10+ year studies:- to quote the initial posting “acute (single high dose) and subacute (28 day) studies” – exactly what is used to show that GM food is equivalent to non-GM food in terms of health risks.

  8. John Q Says:

    Deborah said:

    “There has been no decade long-term independent safety testing that I am aware of. People smoke for 10 years, do drugs, get exposed to pesticides, low levels of radiations, etc, with no apparent health consequences. But that does not prove safety. That is not a study.”

    Good point. I have a friend in Pharma who tells me Tylenol would not pass the drug testing mandated today. And yet it has eased the suffering of MILLIONS.

    I am willing to go out on a limb and say no such study has been done, whether you and I are aware of it or not. For exactly the reasons you suggest. The magnitude of variables that would need to be controlled for to make such a study statistically meaningful would make either the time and/or the number of participants so large as to make it impossible. Not to mention requiring some poor group of individuals to eat only “natural” corn for 10 years, and some other group to eat only GM corn.

    And then we’d have to have to have a RoundupReady corn/BT canola group, and a BT corn/RR canola group, to search for interactions. Plus the RR corn/”natural” canola, and BT corn/”natural” canola, and “natural” corn and RR canola, and “natural” corn and BT canola.

    And then we have smoking drinkers, and non-smoking drinkers, and smoking non-drinkers, and, well, you get the idea. Who do or don’t do drugs, and have or have not been exposed to pesticides, and who do or don’t preserve their foods, and as Larry suggests, do or don’t cook their food. And whose parents were from Europe, and/or the Mediterranean, and/or Asia, and or the South Pacific, and/or….

    PLUS, I hear several companies are working on drought tolerance and nitrogen efficiency in several species, among others.

    So yes, I WAS asking you a question. Can you design, even theoretically, a “long term independent safety study” that would be meaningful, practical, and that would satisfy your concerns?

    Not to mention what you think of as “natural” corn (and “natural” peppers, amongst others) has been undergoing TOTALLY RANDOM “Genetic Modification” for centuries. All of those colors, morphologies, and environmental adaptations we take for granted? Those are all genetic MUTATIONS, that have had NO scientific study or direction.

    Take acorns. We could likely feed another 10% of the population (I admit I made that up, but look how ubiquitous oak trees are) if acorns were palatable. But they are very bitter if untreated, so animals, by and large, DON’T eat them. The Native Americans knew how to treat them, and thus consumed them.

    Why do I bring this up? Because there is another very common tree-nut crop that USED to be bitter. Almonds. But some poor tree mutated (actually, it was the original “nut cell”, not the whole tree), and thus we got the delightfully subtle flavored (and commercial) nuts we have today. But since it was a random MUTATION, it could just as easily have resulted in nuts with CYANIDE in them. Sure, the “cyanide” tree (and it’s offspring) would have been more successful, but we’d have one less commercial crop. But not that poor, mutated tree, which was SAVED from extinction by human action in cultivating it, where other animals would have just eaten it’s nuts into oblivion. And now that tree is arguably more genetically successful than its wild, bitter cousins.

    But there was no “long term independent safety study” made on the non-bitter almonds. Or the orange, yellow, or purple peppers. Poblano, cayenne, jalapeno, or habanero peppers. Or the white, yellow, red, black, or blue corn. Or the plum, cherry, grape, raisin, or beefsteak tomatoes. Or the orange or yellow watermelons. And don’t get me started on the seedless….
    ALL unstudied random MUTATIONS. None of which Monsanto had anything to do with.

    But, IF we wanted to take (and HAD) the time, any company or even individual in the world could grow plants, wait for RANDOM mutations, cross-polinate and EVENTUALLY get right back to where we are today. But we would have NO control over what OTHER mutations were brought along. Me, I’d rather have more control over the process than that.

    So, what are the parameters of your study? How many participants and how many years will it take? Because we need to get started.

  9. Deborah Rubin Says:

    So, Dr. Dan, does this mean that you will not speak to the individual concerns of the AAEM–regardless of how fringe you say they are?

    Can you show me why the Hill Criteria in areas of strength of association and consistency between GM foods and disease does not apply? Do you have any other specific professional criticisms of the studies cited by AAEM? I would like to understand why you so roundly dismiss them. I truly would appreciate your rebuttals or quotes from Monsanto rebuttals, whatever you have.

    Don’t forget, a lot of the scientific laws we now are almost certain are true were far outside of the mainstream once. I don’t believe you can discredit an organization or their position simply because their focus is beyond the norm, perhaps cutting edge. Certainly genetic engineering of crops was thinking outside of the box not long ago. And some of us still don’t see the rationale. Who says the AAEM is so far out? Surely, some of their perceptions have moved into the mainstream–I remember Gulf War vets insisting they were ill, etc. They were met with disbelief, dismissed as pychosomatic, and not given the treatment they needed and still need. Their families became ill. We lost a lot of time. Have you seen any of them? How about this one–Agent Orange causes disease–that is a long battle as well. PCB’s; I’ve seen commercials from the fifties state smoking is good for asthma…

    http://www.aaemonline.org/AboutUS.html

    Who We Are
    The American Academy of Environmental Medicine was founded in 1965, and is an international association of physicians and other professionals interested in the clinical aspects of man and his environment.
    The Academy is interested in expanding the knowledge of interactions between human individuals and their environment, as these may be demonstrated to be reflected in their total health.
    The Academy of Firsts:
    The founders and members of the American Academy of Environmental Medicine are recognized as the first to describe or the first organization to acknowledge …

    Serial Dilution Endpoint Titration
    Sublingual Immunotherapy
    Optimal Dose Immunotherapy
    Food Allergy/Addiction
    Provocation/Neutralization
    Avoidance/Reintroduction Challenge Testing
    Rotary Diversified Diet
    Chemical Sensitivity (MCS)
    Total Load Phenomenon
    Environmental Control in the Home, Workplace, and Hospital
    Chemically Less-Contaminated Foods
    Sauna Depuration
    Hepatic Detoxication Enhancement
    Gulf War Syndrome
    Endocrine Mimicry Disorders
    The Role of Mold in the Development of Systemic Illness
    Yeast Syndrome
    CFID/FMS
    *****************

    As far as Larry’s comments and others about gmo’s being assumed as safe as the non-gm foods humans have been eating in one form or another for thousands of years, these traditional foods are the ones most of us consider GRAS. We certainly have a long history with most of these foods–by reputation and most likely trial and error. Historically, as a people, we learned the hard way. Our cultures know, with some possible exceptions, which foods are safe and which ones can be dangerous–like mushrooms, potatoes, herbs, etc. Most new warnings involve manmade additives, preservatives, supplements, contamination, and novel ingredients from what I see.

    Regarding GMO’s, I would put forth the comments of some FDA scientists assessing the safety of and regulatory issues with GMOs:

    http://www.biointegrity.org/ext-summary.html

    FDA microbiologist Dr. Louis Pribyl stated: “There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering ….” He added that several aspects of gene- splicing “. . . may be more hazardous . . .” (4) Similarly, Dr. E.J. Matthews of the FDA’s Toxicology Group warned that “. . . genetically modified plants could … contain unexpected high concentrations of plant toxicants…,” and he cautioned that some of these toxicants could be unexpected and could “…be uniquely different chemicals that are usually expressed in unrelated plants.” (2) Citing the potential for such unintended dangers, the Director of FDA’s Center for Veterinary Medicine (CVM) called for bioengineered products to be demonstrated safe prior to marketing. He stated: “… CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns.” (10) He explained that residues of unexpected substances could make meat and milk products harmful to humans. And the head of the Biological and Organic Chemistry Section chided agency bureaucrats for turning prior policy “on its head” in attempting to equate bioengineered foods with their conventional counterparts. He also pointed out that lack of definitive evidence that a GE food is dangerous does not assure safety, noting that “in this instance ignorance is not bliss.” (7)

    Commenting on the data at hand, Dr. Robert J. Scheuplein, director of the FDA’s Office of Special Research Skills, wrote: “… the data fall short of ‘a demonstration of safety’ or of a ‘demonstration of reasonable certainty of no harm’ which is the standard we typically apply to food additives. To do that we would need, in my opinion, a study that resolves the safety question raised by the current data.”(15) Dr. Carl B. Johnson of the Additives Evaluation Branch concurred that “… unresolved questions still remain.” (16) [And yes, I did read the original memos]

    Despite the extensive input it received from its scientists about the risks of GE foods and the extent to which they differ from conventional ones, the FDA’s official policy statement declares: “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way ….” (Statement of Policy: Foods Derived From New Plant Varieties, May 29, 1992, Federal Register vol. 57, No. 104 at 22991.) Moreover, the agency has continued to misrepresent the facts. For example, on February 28, 2000, Dr. James Maryanski, the primary FDA spokesperson on GE foods, stated to the OECD Conference on GE Food Safety in Edinburgh, Scotland that the agency’s scientists had merely been asking questions about the various issues involved in bioengineered food. But as their own memos clearly indicate, they were making declarative statements, many of them quite emphatic, about the unique potential of bioengineering to induce unintended and unpredictable negative side effects. Further, on May 3, 2000, the FDA Commissioner declared: “FDA’s scientific review continues to show that all bioengineered foods sold here in the United States today are as safe as their non-bioengineered counterparts.” Yet the year before, the FDA clearly acknowledged it does not perform substantial reviews of GE foods, stating: “FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants … consistent with its 1992 policy.” (Reported in The Lancet,May 29, 1999)

  10. scared stiff Says:

    HOW SAFE IS YOUR FOOD!!!????!!!!
    REALLY GOOD QUESTION>
    Apparently, DR. Dan didnt get the memo on how safe GM food is!!!!!

    I cant wait to see how this article will be refuted and all those working for mansanto on here will say this group is a bunch of crazies.
    OH sure they are a group of doctors and scientist but they are not on the payroll of mansanto so they must be crazy, conspirators.

    FOLLOWING ARTICLE BRINGS INTO QUESTION JUST HOW SAFE IS MANSANTO FOOD!!!!

    F. William Engdahl
    Global Research,
    Friday, May 22, 2009

    US Doctors’ association calls for Moratorium on GMO Foods

    The American Academy of Environmental Medicine (AAEM) has just issued a call for an immediate moratorium on Genetically Manipulated (GMO) Foods.

    In a just-released position paper on GMO foods, the AAEM states that ‘GM foods pose a serious health risk’ and calls for a moratorium on GMO foods. Citing several animal studies, the AAEM concludes ‘there is more than a casual association between GMO foods and adverse health effects’ and that ‘GM foods pose a serious health risk in the areas of toxicology, allergy and immune function, reproductive health, and metabolic, physiologic and genetic health.’ The report is a devastating blow to the multibillion dollar international agribusiness industry, most especially to Monsanto Corporation, the world’s leading purveyor of GMO seeds and related herbicides.

    In a press release dated May 19, the American Academy of Environmental Medicine, which describes itself as ‘an international association of physicians and other professionals dedicated to addressing the clinical aspects of environmental health,’ called immediately for the following emergency measures to be taken regarding human consumption of GMO foods:

    * A moratorium on GMO food; implementation of immediate long term safety testing and labelling of GMO food.

    * Physicians to educate their patients, the medical community and the public to avoid GMO foods.

    * Physicians to consider the role of GMO foods in their patients’ disease processes.

    * More independent long term scientific studies to begin gathering data to investigate the role of GMO foods on human health.

    The AAEM chairperson, Dr Amy Dean notes that ‘Multiple animal studies have shown that GM foods cause damage to various organ systems in the body. With this mounting evidence, it is imperative to have a moratorium on GM foods for the safety of our patients’ and the public’s health.’ The President of the AAEM, Dr Jennifer Armstrong stressed that ‘Physicians are probably seeing the effects in their patients, but need to know how to ask the right questions. The most common foods in North America which are consumed that are GMO are corn, soy, canola, and cottonseed oil.’ The AAEM’s position paper on Genetically Modified foods can be found at http:aaemonline.org.

    The paper further states that Genetically Modified Organisms (GMO) technology ‘abrogates natural reproductive processes, selection occurs at the single cell level, the procedure is highly mutagenic and routinely breeches genera barriers, and the technique has only been used commercially for 10 years.’

    The AAEM paper further states, ‘several animal studies indicate serious health risks associated with GM food consumption including infertility, immune dysregulation, accelerated aging, dysregulation of genes associated with cholesterol synthesis, insulin regulation, cell signalling, and protein formation, and changes in the liver, kidney, spleen and gastrointestinal system.’

    They add, ‘There is more than a casual association between GM foods and adverse health effects. There is causation as defined by Hill’s Criteria in the areas of strength of association, consistency, specificity, biological gradient, and biological plausibility. The strength of association and consistency between GM foods and disease is confirmed in several animal studies.’

    GMO is toxic

    The AAEM paper should give grounds for official rethinking of the current quasi laissez faire regulatory stance to GMO in which the solemn word of the GMO seed companies such as Monsanto is regarded as scientifically valid proof of safety. The AAEM study is worth citing in detail in this regard:

    ‘Specificity of the association of GM foods and specific disease processes is also supported. Multiple animal studies show significant immune dysregulation, including upregulation of cytokines associated with asthma, allergy, and inflammation. Animal studies also show altered structure and function of the liver, including altered lipid and carbohydrate metabolism as well as cellular changes that could lead to accelerated aging and possibly lead to the accumulation of reactive oxygen species (ROS). Changes in the kidney, pancreas and spleen have also been documented. A recent 2008 study links GM corn with infertility, showing a significant decrease in offspring over time and significantly lower litter weight in mice fed GM corn. This study also found that over 400 genes were found to be expressed differently in the mice fed GM corn. These are genes known to control protein synthesis and modification, cell signalling, cholesterol synthesis, and insulin regulation. Studies also show intestinal damage in animals fed GM foods, including proliferative cell growth and disruption of the intestinal immune system. ‘

  11. Deborah Rubin Says:

    Dr. Dan, you can find the bibliography here:

    http://www.aaemonline.org/gmopost.html

    Bibliography: Genetically Modified Foods Position Paper AAEM

    1. World Health Organization. (Internet).(2002). Foods derived from modern technology: 20 questions on genetically modified foods. Available from: http://www.who.int/foodsafety/publications/biotech/20questions/en/index.html

    2. Smith, JM. Genetic Roulette. Fairfield: Yes Books.2007. p.10

    3. Freese W, Schubert D. Safety testing and regulation of genetically engineered foods. Biotechnology and Genetic Engineering Reviews. Nov 2004. 21.

    4. Society of Toxicology. The safety of genetically modified foods produced through biotechnology. Toxicol. Sci. 2003; 71:2-8.

    5. Hill, AB. The environment and disease: association or causation? Proceeding of the Royal Society of Medicine 1965; 58:295-300.

    6. Finamore A, Roselli M, Britti S, et al. Intestinal and peripheral immune response to MON 810 maize ingestion in weaning and old mice. J Agric. Food Chem. 2008; 56(23):11533-11539.

    7. Malatesta M, Boraldi F, Annovi G, et al. A long-term study on female mice fed on a genetically modified soybean:effects on liver ageing. Histochem Cell Biol. 2008; 130:967-977.

    8. Velimirov A, Binter C, Zentek J. Biological effects of transgenic maize NK603xMON810 fed in long term reproduction studies in mice. Report-Federal Ministry of Health, Family and Youth. 2008.

    9. Ewen S, Pustzai A. Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine.Lancet. 354:1353-1354.

    10. Kilic A, Aday M. A three generational study with genetically modified Bt corn in rats: biochemical and histopathological investigation. Food Chem. Toxicol. 2008; 46(3):1164-1170.

    11. Kroghsbo S, Madsen C, Poulsen M, et al. Immunotoxicological studies of genetically modified rice expression PHA-E lectin or Bt toxin in Wistar rats. Toxicology. 2008; 245:24-34.

    12. Gurain-Sherman,D. 2009. Failure to yield: evaluating the performance of genetically engineered crops. Cambridge (MA): Union of Concerned Scientists.

    13. Lofstedt R. The precautionary principle: risk, regulation and politics. Merton College, Oxford. 2002.

    14. Eggen, D. Obama targets food safety: president announces new leaders, groups to upgrade laws. Washington Post. March 15, 2009. p. A02

  12. Dan Goldstein Says:

    Deborah-

    You are right- not every fringe opinion turns out to be wrong. Galaleo is always brought forward as the poster child for this one. There are a few problems with this particular example, however- Galaleo was clearly thought top be RIGHT by the majority of the scientific community. His problem was with the Catholic Church- not the scientists- the usual scenario when non-scientists try to take scientific positions based on a-priori convictions or beliefs. (NOT picking on the Catholic Church here- they happen to be involved in that specific example as a matter of historical fact.) The usual logic is: 1) Galaleo was widely thought to be wrong. 2) Galaleo turned out to be right. 3) It is widely believed that XYZ us wrong. Therefore XYZ must be right. Quod Erat Demonstrandum…

    The problem is that almost everyone widely believed to be wrong IS wrong. The question then becomes- what is the scientific track record of this particular organization? If you look at their list of “firsts” (I am quite familiar with the organization and the website) it is a mixture of broad claims for which they were clearly NOT first (Did they REALLY discover food allergy and the need for proper hygiene in the environment? Are you sure they were the FIRST to call for less pesticides in food?) and specific claims around extremely controversial diagnoses and testing methods.

    What I would tell is that, if you apply the Hill critera which you seem so fond of to the epidemiology and available sicne on most of these claims, they will NOT pass muster.

    See what QuackWatch has to say (or does someone want to claim that Monsanto controls Quackwatch too??)

    http://www.quackwatch.org/04ConsumerEducation/nonrecorg.html

    As to the specifics- References 6-11, these have already been rebutted. Puztai’s work was discredited outright and withdrawn, for example. Monsanto has spoken to these studies before, and I do not have time or space to put all of the rebuttals here- but we can work through them over time individually.

    As to the yield allegations, please see For the Record on Monsanto.com.

    What is particularly telling is the long list of safety references which AAEM did NOT bother to reference- a clear sign that they want to look only at one side of the issue.

    Finally- remember that the AAEM membership has vested financial interests here too. I am not saying Monsanto does not- everyone knows we do. It is fine to be sceptical about Monsanto- but you need to apply an equal degree of scepticism on both sides of the equation.

    dag

  13. John Q Says:

    Deborah, I find it interesting that you keep calling for more studies and data (presumably using the widely accepted “scientific method”) and yet you (and also “scared stiff”) also continue to quote from AAEM, who (admittedly from MY “biased” reading) seem to flaunt “scientific method” at every turn. For example, I feel they have decided the answers to their questions before they begin collecting data, then they discard any data that don’t support their “conclusion”, and they misrepresent the data that DO support their “conclusion”.

    As a specific example, a quote from one of the links you provided (from their bibliography):

    “Indeed, new plants developed through TRADITIONAL breeding techniques may not be evaluated rigorously using risk assessment techniques.” (CAPITAL emphasis added by me.)
    So, should we start testing traditional food tomorrow? For example, nearly every commercial crop is a hybrid, and has not been tested for safety.

    To again get specific, are you aware of Panama Disease, and the move from Gros Michel to Cavendish bananas? This is being addressed by HONDURAN AGRICULTURAL RESEARCH FOUNDATION (FHIA)http://www.honduras.com/fhia/ has been cross breeding wild banana types for decades. “They already have created new banana varieties that are resistant to the Cavendish diseases however the first new varieties have a distinct apple flavor while otherwise being very similar to the Cavandish in look and handling.” Will we need to test these bananas, too?

    Also, all but three dates in one of your links (http://www.biointegrity.org/ext-summary.html)are from the (early) 1990’s, the latest one from January 2001. The state of the art in ALL technology, and particularly GMO’s, has changed quite a bit since then. Not to mention there have been NUMEROUS additional studies. Can you please find us something reported this century?

  14. Dan Goldstein Says:

    David-

    I want to address your questions specifically.

    Yes, I am saying that Genetically Modified Foods are as safe as Conventional Foods, which is the criteria for marketing. Existing food is not intrinsically safe- most food allergies are to milk, eggs, wheat, seafood, nuts, and other common foods. Salt causes hypertension, high fat diets cause heart disease and stroke, the vast majority of carcinogens in food are naturally occuring compounds, etc., etc.

    In fact, GM foods undergo far more testing and review than conventional foods have ever been subjected to. Can someone please show me the toxicology studies on carrots? Wheat? Is ham safe (contains carcinogens and fat)? Is cheese safe (contains saturated fats)? And- worry of worries- what happens when we combine ham and cheese in a sandwich? What if there is an unexpected synergistic effect of ham and cheese?

    The fundamental issue here is that there does not exist any fundamental test to assure absolute guarantee of no possible harm- no matter how mcuh you do, you can always hypothesize some theoretical unrecognized harm. Thus there is no such thing as “absolutely safe”.

    Given the extent of testing and review of current GM foods one can argue that they may in fact be safer than conventional- or at least that we can be MORE sure of their safety than most foods which have never been assessed.

    Do I think GM crops (I will talk about crops, not foods- but I include both here- it is the crops that are in the environment) or pesticides can cause harm to the environment?

    First- lets get clear- are we talking about the TECHNOLOGY or the SPECIFIC PRODUCTS? Virtually any TECHNOLOGY can cause harm to the environment (fire, for example) and GM and Pesticides are presumably no exception. We have known examples of pesticides having impacts. While I am not aware of clear examples of existing GM crops causing environmental damage over and above that due to agriculture in general, this does not preclude the possibility of harm as a result of the TECHNOLOGY.

    In regards to the currently available crops, we need to set the stage and recognize that ALL AGRICULTURE has impacts on the environment. The bulk of loss of biodiversity is not due to pesticides or GM crops- it is due to cultivation. The relevant question here is not whether the TECHNOLOGY can theoretically cause harm (the answer to that question is almost always yes)- the relevant question is whether the ACTUAL IMPLEMENTATION OF THE TECHNOLOGY can cause harm, and if so, HOW THAT HARM COMPARES TO EXISTING TECHNOLOGIES. (There is a tendancy to assume that yesterday’s technology was zero risk and that all new technology must add risk- a fallacy that will get us no place fast.)

    SO- Direct answer to your question: While pesticides can (and have) presented risks to the environment and while GM TECHNOLOGY does present theoretical risks (as does any technology), the current implementations of GM technology do not in my opinion present any significant risk over and above previously existing technologies, and in the area of pesticide use, have in fact presented real opportunities for reducing pesticide use and managing pesticide related risks.

    If you are waiting for a food production technology that is intrinsicallly free of all risk and is without impact on the environment- so are all the rest of us! But so far it does not exist- the population is growing fast- and chances of the perfect technology showing up are slim to none.

    If you are expecting me to claim that GM (or pesticides) is the “perfect techology- intrinsically free of all risks and presenting zero impact on the environment” – only a delusional person could make such a claim. As with food safety- I can only state that the risk presented overall by GM is at worst commensurate with technologies and is in all likelihood reduced in comparison to previously existing technologies employed for global food production.

    Finally, please note that my comments do not preclude the existance of locally (or perhaps even globally) less impactful technologies. The problem is, we have a world to feed. If you want humanity to be less impactful, population reduction is a very effective way to do it… but the idea is survival last I checked.

    dag

  15. Deborah Rubin Says:

    John, the reason most of the links you are talking about come from the 1990’s is that they were referencing the initial introduction, deregulation, marketing, and safety data of gmo’s. This is what some scientists at the FDA said about the deregulatory, substantial equivalency, GRAS policies being proposed. That is my point. There were objections and concerns. All subsequent policy hinges on this framework.

  16. Deborah Rubin Says:

    And, John, from this century, starting last year, APHIS docket 2008-0023:

    Title Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms
    Type Rulemaking
    Category Genetically Modified Organisms and Products
    Summary
    Program Biotechnology Regulatory Services

    http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480903a8e

    Which is still open for comment for about a month, should anyone feel so inclined. After reading the proposed changes, anyone can click on the yellow dialog icon at the right under ‘add comments’ and make a comment. You can also read any comments already made. The current process, definitions, and policies are being reviewed. This commenting period has been extended due to the thousands of comments received. Apparently many of us are concerned with the original regulatory approach, scientists and doctors included, esp in view of the years of experience we have had.

    And one more thing, about your comment: “But, IF we wanted to take (and HAD) the time, any company or even individual in the world could grow plants, wait for RANDOM mutations, cross-polinate and EVENTUALLY get right back to where we are today.”

    If you mean the gm crops we have by “where we are today,” I don’t think so. Realistically, it would most likely never happen. Not if you are referring to GM. Extremely, extremely unlikely.

    Furthermore, I don’t presuppose a need for Bt and RR crops, either. They will not save the world and are not needed or even the most sustainable, applicable methods in the opinions of many.

  17. Deborah Rubin Says:

    Dr. Dan, One of my main problems with your post is that you start out saying Monsanto is responsible for its products, but I don’t see the responsibility being exercised. How is Monsanto responsible to consumers who want their food labelled so they can choose whether or not to eat it? How is it responsible to farmers whose conventional and organic crops are contaminated by gmo’s, further limiting consumers’ choices? Even though the law still allows these contaminated crops to be sold in the US as they were planted, this is not truly honest with the consumer or environmentally responsible. Why isn’t Monsanto responsible for preventing contamination?

    As far as food safety goes, the criticisms I see Monsanto noting For the Record are similarly noted by independent scientists reviewing Monsanto’s safety studies. (The eternally recurring theme in my mind and what I initially hoped to explore on your blog when I heard about it.) Do we have any adequate safety studies from which to draw conclusions? I certainly never meant to imply the xyz fallacy; that’s plain silly. And I think you know that. My argument is that not everything that is scoffed at must be true. Some of it probably is, some is not. But what’s what? To argue that since our traditional diets have not been stringently studied, Monsanto should not have to stringently study it’s inventions is illogical to me. It’s quite a premise to jump off of and absolves Monsanto of it’s aforementioned accepted responsibility for it’s inventions. This is why I cited some of the FDA scientists who were at odds with the policies used to approve gmo foods.

    I was satisfied with my food and it’s inherent risks before cry toxins were added, and roundup tolerance, the metabolites of that process, and all of the unintended changes–some of which have been documented to occur–due to the GE process itself. But why should I accept further risk? That is asking more of me and all of us, and where is Monsanto’s responsibility? And I’m not accepting the argument-which I allege is a fallacy–It is to feed the hungry world. That is another untested, contentious premise among politicians, scientists, NGO’s, and consumers. It is based on a lot of wobbly assumptions and ignores a lot of interrelated, integrated issues, scientific and social.

    Perhaps some of the conflicting data (the aforementioned recurring theme on this blog and elsewhere) in the studies of the same GM variety is due to the differences in dna arrangements that have been documented and/or those that still remain unknown in transgenic crops of the same variety. I say “perhaps,” because I certainly do not claim to know, but do you? Perhaps it is in ill-designed experiments. Perhaps, we ought to be sure with more experiments. Now that makes sense to me. But the fact is, the experiments thus far are not consistently conclusive, and I find that troubling. All of the conclusions are questionable to me and instill no great degree of confidence.

    I was hoping that since you are so emphatically opposed to the AAEM’s claims of meeting Hill’s Criteria and you have expertise in the field, you would specifically comment on your opposition. I think that would be a very constructive, concrete place to start. While I did find some of the references from the bibliography in For the Record, I did not find them all. No matter what you think of AAEM, I think they raise valid points that others have been raising as well, and that need to be addressed.

  18. Mica Says:

    I’m still waiting on Deborah’s answer to the parameters of a long-term health study on traditional and GM foods.

  19. John Q Says:

    Deborah said:

    “If you mean the gm crops we have by “where we are today,” I don’t think so. Realistically, it would most likely never happen. Not if you are referring to GM. Extremely, extremely unlikely.”

    That is why I said, “But, IF we wanted to take (and HAD) the time,… EVENTUALLY”

    As far as I am aware, NONE of the GM genes are man-made. They all come from SOMEWHERE in nature. BT genes from BT bacteria, and Roundup Ready genes from common soil bacterial. Drought resistant genes and nitrogen utilization genes from other plants, as I understand it.

    So, these genes ARE natural, in other organisms, and are the result of natural (random) mutation and selection.

    So EVENTUALLY, those genes could naturally occur in the corn (or cotton, or etc.) genomes. There are also naturally occiuring viruses and other agents that can speed up the process of random mutations, if we want to utilize those natural processes.

    I agree with you that it is unlikely to happen in a USEFUL timeframe. But then, isn’t that the REAL difference in our viewpoints? I see it as statistically inevitable and thus want to take advantage of it now, and you don’t?

  20. John Q Says:

    Deborah said:

    “They will not save the world and are not needed or even the most sustainable, applicable methods in the opinions of many.”

    In the opinions of many, the CURRENT HUMAN POPULATION on this planet isn’t sustainable. Where do you stand on that, and how do you propose we address it?

    Let’s take a further look at this sustainability point, shall we? Let’s go for the easy analysis, and ignore water, and fertilizer, and pesticides, and pick something simple. One of the big, unnecessary (from a caloric viewpoint) costs of food is transportation. So much so that there is a “localvore” subculture on your side of the fence. A common localvore metric is 100 miles (160 km). They try to eat food grown within 100 miles of their house. Whereas most of the apples in US supermarkets come from the Pacific Northwest or New Zealand, for example.

    So let’s do a thought experiment. I DON’T want to know your specific answers, as they may provide us “identifying information”, but I think we would ALL benefit from each performing this analysis. But I’ll let YOU pick the radius, rather than force 100 miles on you. Let’s just call it R. But remember, as R increases, the area affected increases by R^2.

    What crops are grown within R of your house? What crops CAN be grown within R of your house? This will help you determine what foods you will have to give up altogether. For example, bananas (and pineapple) don’t grow the same places blueberries do, by and large.

    Now, look at the harvest seasons for those foods. Most are less than a month. How much space are you willing to allocate in your home for off-season consumption? How good at canning are you?

    Finally, for ease of analysis, let’s convert those crops (and harvest volumes) into just calories and ignore the other nutrition. Assume a 1,500 calorie a day diet. How many people can those crops support? Because odds are, either you have WAY too few people for your calories, or way to MANY. So, who are you going to tell they have to give up their land, or who are you going to tell they have to move out to balance people with calories? I won’t make you trade off land for people, but in general, if you have people move in, you have less land to grow crops.

    OK, now let’s do the same analysis for Fargo, ND, and New York City. Or would you rather use Chicago, Or Mexico City?

    So, do you TRULY mean sustainable, or are you just using it as a buzzword to beat up companies like Monsanto that are trying to develop CONstructive solutions to a larger problem?

    Or do you mean something different by “sustainable”, that doesn’t include transportation costs, but perhaps only costs attributable to Monsanto? Because the next version of this analysis uses water rather than calories, and includes the water costs for your car, house, and appliances.

  21. Deborah Rubin Says:

    Mica Says:

    May 27, 2009 at 12:36 pm
    I’m still waiting on Deborah’s answer to the parameters of a long-term health study on traditional and GM foods.

    *******************
    While we are speaking of responsibility, is that my responsibilty? Am I qualified to do such a thing? I feel like I am in this long-term experiment without adequate controls–even though I wasn’t the one who introduced gmo’s into the environment and food chain. I found out about gmo foods in my diet just after the Starlink incident. The lack of long-term safety data and consent is one of the most serious criticisms of the implementation of gmo’s. We have the cart before the horse. I, personally, would like to see Monsanto and other biotech companies survey the independent scientists, NGO’s, government officials, and consumer groups, etc, who call for more testing and have expertise in that area. And do it publicly under APHIS or what ever regulatory body would oversee such a policy.

    But certainly, I don’t believe it would have to involve people eating gm corn as all of their diet for years. Not many, if any, people do that and the nutrition would not be adequate to sustain the test. That doesn’t reflect a varied diet necessary for health which is necessary for a long-term experiment. Medicines are not tested that way in clinical trials. They are tested in dosage ranges. Again, this gets back to the original FDA questioning of the whole process, how to ensure safety, how to define PIP’s or what-have-you. Are they pesticides, additives, how much of the function of the plant has changed, none or all of the above? I don’t know, but I would have liked to have known before I started eating them. I still want to know and believe I have a right to know.

    My more realistic immediate suggestion to Dr. Dan and Monsanto is to repeat the studies that have come up with different conclusions. Expand upon the studies with your expanded knowledge of genetic engineering since the crops and foods were introduced. If the experiments are not repeatable, that is an indication of a problem somewhere. Where/what/who is the problem? We should know if we want to be confident. Publicly repeating the studies, agreeing on methodology, data collection and interpretation, with independent witnesses would be sound, transparent start.

    John Q, Constructive is part of sustainable as I see it. Speaking of a change for the long term, not just a temporary fix that may do more harm than good, if it isn’t constructive, can it be sustainable and vice versa? I’m not certain sustainable has to local. Otherwise people who live in deserts, cities, or on marginal lands would surely starve or suffer unnecessarily. Local is a part of the solution as I see it.

  22. Deborah Rubin Says:

    John says,

    As far as I am aware, NONE of the GM genes are man-made. They all come from SOMEWHERE in nature. BT genes from BT bacteria, and Roundup Ready genes from common soil bacterial. Drought resistant genes and nitrogen utilization genes from other plants, as I understand it.

    So, these genes ARE natural, in other organisms, and are the result of natural (random) mutation and selection
    _______________________-
    The arrangement of the inserted construct is not natural, as I understand it.

  23. scared stiff Says:

    Nothing is sustainable not forever. Of course there are problems with sustainability by and large but your solution to this specific problem is by genetically altering the dna of plants. By doing this, and it shouldnt be denied, is the unknown factor of what these alterations will do in the future. How will it impact and or change plants and how will it change humans. What you have is a new idea that is being lobbied so vigorously with your friends in government positions that these basic protocols are overlooked. What sort of contingency plan does monsanto have for possible future problems from what ever various issues that might arise.
    I.E. New allergens created? Systemic eradication of species and/or new viruses that are far more virulent because of having mutated from all the crazy things being injected into and sprayed onto our plants.
    I often wonder if there is a responsible group within your company that might actually be evaluating these sort of issues and whether or not they have set up some sort of emergency protocol for when things will go horribly wrong.(Lets face it, in everything there must be factored in the unknown. IN everything there are accidents and tragedies or failures. Most planes make it safe but some do crash. MOst nuclear plants never have a problem but wait long enough and one of them is sure to meltdown.)

    Off subject completely. I will say this. One good thing about the horrible demise of our economy ( another example of how everything must crash in some sense eventually) is that it has limited many many farmers in our country from gaining the loans needed to buy there pesticides and seeds. Which in turn does only one thing plummet the profit of monsanto. ANd hopefully create some awareness of the dangers of said company. Lets not forget the horrible down side of all of that. Farmers (some my direct family) are once again living off of scraps and losin land and home. (NOt to mention darn near everyone else)> but I have been taught to look on the bright side loss of profits might just might make the big wigs in monsanto reevaluate there whole idea of things and make them grow a conscience. I have noticed something very strange in this recession of ours. And that is that when people find themselves without money and in dire straits to take care of their family and such. I have noticed a resurgence of people becoming conscionable of their lives and how they project their lives onto others. I wonder if this works on a larger level. With corporations or even governments. I dont know just a thought.

  24. Dan S Says:

    scared stiff,

    It’s already been said a hundred times, but I suppose it won’t hurt to reiterate the fact that random genetic mutation occurs plenty within nature and that nature doesn’t have any Quality Assurance personnel trying to prevent the creation of a new allergen or other “crazy things”. I believe that this is the point of the original post: by and large GM food is just as safe as “traditional” food and likely a little more.

    As for your comments about the economy, I don’t know what newspapers you’re reading but Monsanto is doing very well, especially for being in the middle of a recession. It’s not just Monsanto, either; seeds and traits in general are a great area to be in. In fact, Monsanto’s principle competitors (DuPont and Dow Chemical) have shifted focus away from chemical production to agriculture in light of these trends.

  25. John Q Says:

    Deborah said:

    “Am I qualified to do such a thing?” [Design a long-term study.]

    Deborah, I’d have to say, if you are qualified to analyze and interpret the data you keep asking for, then you are qualified to design the study. And if you AREN’T qualified to design the study, then you are also not qualified to analyze and interpret the data you keep asking for. So you tell me.

    Deborah said:

    “Medicines are not tested that way in clinical trials. They are tested in dosage ranges.”

    Yes, they are, for at least part of the study. But their intended primary effect is already known, and persons taking any drugs that go anywhere NEAR that effect are excluded from the study, to make it easier to establish cause and effect. Since there are no known effects to GM food other than nutrition, we have to exclude any other sources of nutrition to see “our” effect, or have a HUGE number of test subjects to allow for all variances of external nutrition to be “averaged out” to see our effect. And since we have been (possibly un-informedly) performing this experiment for the last ten years and seen NO effect, we would have to run our rigorous study for at least as long.

    It is MY feeling that any effects from GM food have already been proven to be down “amongst the statistical noise”, at or below those introduced by preservatives, variations in storage temperature, and natural decay processes once the organisms have been harvested.

    I feel obligated to point out, also, that you are inadventently lobbying for monocultural crops, because otherwise the magnitude of natural genetic variations of any organism dwarfs any results obtained by all of this testing. Is that what you intended?

    Deborah said:

    “I’m not certain sustainable has to local.”
    Yes, it does. Because if “you” disallow chemical fertilizers and pesticides (some made from petroleum products, but in any case not “natural” to the environment the crops are grown in), then you have to also disallow the use of excessing transportation and refrigeration. And yes, people who live in desserts or on marginal land WOULD have to move. That is what sustainable REALLY means. Otherwise, you are cherry-picking the data (and definitions) to prove your “point”, and ignoring all of the data that doesn’t support your “point”, as we have discussed earlier. I suppose you can DEFINE it any way you want, but it risks becoming meaningless. Unless, again, of course, you are just using it as a buzzword to beat up companies like Monsanto that are trying to develop CONstructive solutions to a larger problem?

    As for cities, they are NOT natural, nor are they sustainable (even ignoring the food part). In fact, until modern sanitation and water systems were put into place, cities had a net NEGATIVE growth rate, if you factored out immigrants. To go one step further, most of our infectious diseases were “incubated” in cities. It takes a minimum population density to make most diseases “effective”. The ultimate “sustainable” lifestyle is Hunter-Gatherer, but I just don’t see many of us going back to that. And certainly not 9,000,000,000 of us.

  26. John Q Says:

    Deborah said:

    “The arrangement of the inserted construct is not natural, as I understand it.”

    Neither was the mutation that made large ears of corn possible, or non-bitter almonds, or rye with usefully sized seeds.

    Or at least they WEREN’T natural, until they WERE.

  27. Deborah Rubin Says:

    John Q Says:

    June 1, 2009 at 9:20 am
    Deborah said:

    “Am I qualified to do such a thing?” [Design a long-term study.]

    Deborah, I’d have to say, if you are qualified to analyze and interpret the data you keep asking for, then you are qualified to design the study. And if you AREN’T qualified to design the study, then you are also not qualified to analyze and interpret the data you keep asking for. So you tell me.

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

    John, once again I will gladly tell you, I am asking for the studies to be publicly reviewed here on your website. Personally, I would like to see that review done by qualified scientists, but did not limit my request to that. This is what I am asking for, that Monsanto scientists answer the questions and concerns of other scientists and consumers. I would also like to see the safety studies repeated publicly and in conjunction with other scientists.

    There are no controls to the current open-ended “feeding study,” so you can not possibly rule out health effects. That makes no sense. There are increases in the diagnoses of many diseases as we have stated over and over. The variables are many, including gmo’s.

    I don’t know how you come to define “sustainable agriculture.” We will never eliminate energy inputs, but the source of the energy may and hopefully will change over time. The definition you provide is your own, limitations and all.

    Arpad Putzai on genetic engineering and the danger; I would like his review of Monsanto’s safety studies and his input on further research:

    http://www.organicconsumers.org/articles/article_18101.cfm

    You were initially supportive of genetically modified foods, is that correct?

    Yes, I thought at the time on the basis of rather poor understanding of genetic modification that it was a good idea. As we progressed with our experimental work we found all the snags and I had to re-assess my ideas.

    What negative impacts did you find with GM potatoes you were developing?

    The first problem that we encountered was when we tried to correlate the protection of the potato plant leaves against aphid attack with the transgene expression level. We found there was very little or no correlation at all. That is a major flaw, sufficient to question the validity of the whole idea. The next was that the transgenically expressed insecticidal protein did not only damage the aphid pests but also their natural enemies, such as the ladybugs. What was particularly damaging for the validity of genetic modification was when we found that diets based on GM potatoes affected the growth, organ development, and immune reactivity of young rapidly growing rats. The final straw was when we showed that the damage originated not from the transgene and its expressed product but from the damage caused by the insertion of the transgene, probably due to insertional mutagenesis.

    Why is genetic engineering a risky technology?

    Gene insertion is a major problem. You cannot direct where the splicing of the genetic construct will happen. It is well known that when you insert a genetic construct into the DNA network of a plant, you create changes in that network. As a result, you will get changes in the functionality of the plant’s own genes. They may become more active or silent. The effects will be unpredictable and uncontrollable. It can sometimes cause irreparable damage to the genome. This is insertional mutagenesis.

    The biotechnology industry simply overrides this concern. They say we don’t have to worry about it, and if you raise your voice, you are called a Luddite.

  28. Deborah Rubin Says:

    (sp) = Arpad Pusztai—sorry.

  29. Deborah Rubin Says:

    John Q Says:

    June 1, 2009 at 9:25 am
    Deborah said:

    “The arrangement of the inserted construct is not natural, as I understand it.”

    Neither was the mutation that made large ears of corn possible, or non-bitter almonds, or rye with usefully sized seeds.

    Or at least they WEREN’T natural, until they WERE.

    ***********************
    Did those “natural” genetic mutations or hybridizations cross kingdoms or domains? I would like to hear Monsanto’s appraisal of this opinion:

    http://www.psrast.org/mianbree.htm

    by Dr Michael Antoniou, senior lecturer in molecular biology at one of London’s leading medical schools and 17 years experience in the use of genetic engineering leading to clinical applications

    The greatest claim of those who endorse the use of GE in agriculture, is that it is a safe, more precise and natural extension of traditional cross breeding methods for generating novel varieties of crops and farm animals. It is said that this new technology simply gives nature a helping hand with something that would happen anyway. The aim of this article is to assess GE in agriculture from a technical and basic genetics viewpoint focusing in particular on plants and animals. We will see that technically speaking, the use of GE in agriculture is a crude and imprecise technology which bears no resemblance to traditional breeding methods for producing new varieties of crops and farm animals.

    Firstly, there is the information content of each gene; that is, what gene carries the blueprint for which protein. Secondly, genetics has taught us that the activity or expression of each gene is extremely tightly controlled or regulated. Put simply, each gene has it’s own set of sophisticated on-off switches to drive it’s expression ensuring that the correct protein and therefore appropriate structure and function, is present in the right place, time and quantity in the body.

    Just as all forms of life are interdependent upon each other for survival and growth, no gene works in isolation from all other genes. The latest discoveries tell us that genes are arranged along the DNA in groups or “families”. The function of a given gene in a group is dependent on all the other genes that are present within the same family. Furthermore, the genetic activity in one family of genes can effect the function of genes in other groups of genes. It is also clear that genes and the proteins that they give rise to, have co-evolved together to form an extremely intricate, interconnected network of finely balanced functions the complexities of which we are only just beginning to understand and appreciate. Such tight control of gene activity means you will never find liver functions in your brain or leaf specific processes in the fruit and vice versa! In addition, Nature has also evolved mechanisms whereby cross breeding can only take place between very closely related species. With traditional breeding methods, different variations of the same genes in their natural context (within the necklace of pearls) are exchanged. This preserves tight control and complex interrelationships between genetic and protein functions that are vital for integrity of life as a whole.

    GE allows the isolation, cutting, joining and transfer of single or multiple genes between totally unrelated organisms circumventing natural species barriers. As a result combinations of genes are produced that would NEVER OCCUR NATURALLY. Transgenic crops containing genes from viruses, bacteria, animals as well as from unrelated plants have been generated.

    These effects combine to produce a totally unpredictable disturbance in host genetic function as well as in that of the introduced gene. The resulting disturbance in biochemical function can unexpectedly produce novel toxins, allergens and reduced nutritional value.

    Conclusion: GE and Traditional Breeding Methods Are Worlds Apart

    The totally artificial nature of GE does not automatically make it dangerous. It is the imprecision in the manner by which genes are combined and the unpredictability in how the introduced gene will interact within it’s new environment which results in uncertainty. The balanced gene functions that have evolved together and which are preserved with traditional methods, are lost with GE.

    Therefore, from the standpoint of the fundamental principles of genetics and the limitations in the technology, GE is neither more precise nor a natural extension of traditional cross breeding methods. If anything the opposite would appear to be true.

    Therefore GE foods possess new and unique safety considerations both in terms of health and to the environment. The availability of safe, sustainable, natural methods of breeding and husbandry utilising the many thousands of different varieties of a any given food crop, makes the risks associated with GE foods simply not worth taking. These risks are even less acceptable when one takes into account the fact that once released into the environment, genetic mistakes/pollution cannot be recalled, cleaned up or allowed to decay like agrochemicals or a BSE epidemic, but will be passed on to all future generations indefinitely.
    **********************
    More elementary genetics info from PSRAST:

    http://www.psrast.org/mianbrbr.htm

  30. Deborah Rubin Says:

    Would Monsanto comment on this finding?

    http://www.psrast.org/maize3month.htm

    Suspect toxicity of GE Maize
    Mice were fed for three months with Monsantos GE Maize and a control group of the same kind of mice were fed ordinary maize. Blood and urine tests were taken during and after the test period. After three months all mice were killed and their bodies were carefully analyzed. The study was made by Monsantos own scientists at the MSE-N laboratory.

    67 measurements differed significantly, all indicating a toxic influence. This included:

    12 properties of blood cells (including hematocrit, platelets, neutrophil count, lymphocyte count, monocyte count, mean corpuscular volume and hemoglobin concentration of erythrocytes),
    18 clinical lab parameters (including a/o albumin, urea, creatinin, alkaline phoshpatate),
    9 urine measurements (including creatinine and creatinine clearance),
    6 organ weights (including brain, heart liver) and
    14 measurements of body weight, and body weight changes
    8 measurements of food consumption
    Moreover there were significant differences, in some measurements, between males and females.

    Professor Gilles-Eric Seralini at the French Research Institute CRIIGEN found that the statistical analysis used by the Monsanto scientists was not suitable for detecting important differences. Also, no toxicological, biological or medical (pathological) experts had assessed the results. The raw materials including the organs and the microscope slides of the organs were kept confidential, so independent scientists could not analyze them.

    Because of these weaknesses in the study, important differences may have remained undetected. Professor Seralini found that the analyses don’t exclude that the Maize is toxic, and therefore more research is required before it can be concluded that it suitable as food. He pointed out that there is no scientific excuse for keeping the results secret and that it is unacceptable that the approval of a product is made only on the basis of research made by a manufacturers own scientists.

    Seralini also emphasized that much longer studies are needed to safely exclude harmful effects. And he found it necessary that independent scientists must do the research in order to secure a reliable safety assessment.

    Source: (“Report on the NK 603 Maize by Monsanto company”, June 2007 by CRIIGEN, France.)

  31. Dr. Dan Says:

    This is not hot news- it was long ago rebutted, and more will follow either here or on our website For the Record- I’ll post a link if we put it there.

    When you do statistical tests, you see a lot of random variation. YOu can flip a coin 5 times and get 5 heads… 1 in 32 times… so what does it mean if you pick out a penny and toss it 5 times and get 5 heads? Have you found a 2-headed penny? Probably not… about 3% of the time this happens by chance alone. We usually set the “false positive” rate at 5% (p = .05, ie. 95% sure the result is NOT due to chance- but 5%- 1 in every 20 tests- will STILL turn up “positive” by random variation alone.

    Now take a group of rodents and run a complete battery of hematology and chemistry tests as well as body weights and other measurements- say 40 different tests, separately for each gender, and run them weekly over a 12 week study. Thats 40 x 2 x 12 = 960, then add in all organ weights and various food consumption parameters. I have not added up all the specific comparisons in this study- but one can easily do 1000 comparisons in such a study with only a single test and control item. 5% will come up positive by chance alone at p = .05, or about 50 spurious comparisons.

    How do we determine what is meaningful in such a scenario? One has to look at this data over time. The percentage of lymphocytes on the white bllod count may be up in males on week 6. What does this mean if is normal in the weeks preceeding and following, is normal in females, and there is no evidence of hematologic dysfunction? Absolutely nothing.

    THIS is where those Hill Critera you were so enthusiasticly endorsing last week actually DO apply- inconsistent findings with no dose response and no biological plausibility probably mean nothing.

    The study referred to has been looked at by numerous regulatory agencies both before and after the paper by Seralini and others “re-interpreting” the studies using non-standard approaches. These agencies are presented with raw data as well as interpretive analysis, and have concluded that no adverse effects were demonstrated in this study.

    While there is “no scientific excuse” for confidentiality, there is good business reason for confidentiality, as millionsa are invested in these studies, and they can be used by others to regester copy-cat products. This is a fundamental problem in property law, and this will remain the situation unless the law is altered.

    As far as the “analysis not excluding the possibility that the product is toxic”- we have already discussed the epistemological limits of knowledge. NO study can exclude the possibility of a result that was not looked for in the study- we never know what we do not know- about ANY food- conventional or otherwise. We DO know what we know- which in the case of GM foods is far MORE than for any foods in human history.

    If you want to put in a system where the public is resposnible for funding product safety and effecacy testing for foods, drugs, cosmetics, and other products- be my guest. Thus far there seems to be a dearth of people willing to pick up the cost. The discussion is always the same- why should I have to pay for THEIR product? To date, society has decided that the manufacturer needs to pick up the tab, and we do.

    Society will need to choose the model- we can let the manufacturers do the work and pay for it out of the profits generated by their efforts, we can let society pick up the tab for such research, or we can forego technological progress because nobody will pay for the testing. Just remember that the problem pertains not just to foods, but to every product you use every day- from seat belts to antibiotics…

    dag

  32. John Q Says:

    Deborah said:

    “I am asking for the studies to be publicly reviewed here on your website. Personally, I would like to see that review done by qualified scientists, .. … I would also like to see the safety studies repeated publicly and in conjunction with other scientists.”

    Deborah then goes on to quote at length an interview from Arpad Pusztai, published in June 2009. But as far as I can tell, it is the result of work Dr. Pusztai did in or before

    1998.

    I would also like to see the public reviews and the safety studies of Dr. Pusztai repeated publicly and in conjunction with other scientists. Because all I saw in his interview was personal opinion, which can be neither refuted nor verified.

  33. John Q Says:

    In particular, Dr. Pusztai said:

    “The next was that the transgenically expressed insecticidal protein did not only damage the aphid pests but also their natural enemies, such as the ladybugs.”

    I am unclear on this.

    Is he saying that OTHER non-transgenic insecticides DON’T damage the natural enemies of pest insects, which would be amazing,

    or that

    transgenically expressed insecticidal protein did not only damage the aphid pests but also
    ONLY
    their natural enemies, such as the ladybugs (unfortunately through ingestion of poisoned but still living aphids), and not other non-associated insects in the local environment,
    which I would think would be a very GOOD thing.

  34. John Q Says:

    Doborah said:

    “Did those “natural” genetic mutations or hybridizations cross kingdoms or domains? I would like to hear Monsanto’s appraisal of this opinion:

    http://www.psrast.org/mianbree.htm

    I still don’t speak for Monsanto, but my take is
    the only timeframe I can find in THIS article is “(Living Earth, Jan. ’97)”. The state of the art for GM manipulations AND testing has progressed quite a bit in the last 12.5 years, so likely many of these concerns have been addressed.

  35. John Q Says:

    Thanks, Dr. Dan.

    I have to admit I am not qualified to rebutt that particular posting!

  36. Deborah Rubin Says:

    John Q, I would like to see Pusztai’s experiment repeated also. Yes, this study was done in the 1990’s; I am certainly not trying to make a secret of it. The date in no way invalidates the findings. I was quite sure that you at Monsanto are aware of Pusztai’s work.

    http://www.organicconsumers.org/articles/article_18101.cfm

    Arpad Pusztai was one of the first scientists to raise concerns about the safety of genetically modified foods. In the late 1990s, Pusztai, a respected molecular biologist, conducted research on GM potatoes for the Rowett Institute in Scotland. The potatoes were genetically altered to produce lectins, natural insecticides, to protect them against aphids. Pusztai conducted feeding studies on rats and found that the potatoes damaged the animals’ gut, other organs, and immune system. In 1998, Pusztai expressed his concerns about GM foods on a British television program and was promptly suspended and forced to retire from his position. Dr. Pusztai’s research was later peer reviewed and published in The Lancet, a leading British medical journal.

  37. Deborah Rubin Says:

    Dr. Dan, Can you speak to the other differences Seralini listed and why Monsanto feels they are not significant:

    “67 measurements differed significantly, all indicating a toxic influence. This included:

    12 properties of blood cells (including hematocrit, platelets, neutrophil count, lymphocyte count, monocyte count, mean corpuscular volume and hemoglobin concentration of erythrocytes),
    18 clinical lab parameters (including a/o albumin, urea, creatinin, alkaline phoshpatate),
    9 urine measurements (including creatinine and creatinine clearance),
    6 organ weights (including brain, heart liver) and
    14 measurements of body weight, and body weight changes
    8 measurements of food consumption
    Moreover there were significant differences, in some measurements, between males and females.”

    Do you, like Seralini, believe further independent, long-term studies are necessary to ensure no harm comes from these noted differences?

    You said, “How do we determine what is meaningful in such a scenario? One has to look at this data over time. The percentage of lymphocytes on the white bllod count may be up in males on week 6.”

    I don’t know. Does it mean anything, what would have happened had the experiment continued or been repeated? Was there immune response to something–if so, do you know what, was it related to the food? What about the other effects–organ weight differences, etc, noted by Seralini?

  38. Deborah Rubin Says:

    Dr. Dan says

    “If you want to put in a system where the public is resposnible for funding product safety and effecacy testing for foods, drugs, cosmetics, and other products- be my guest. Thus far there seems to be a dearth of people willing to pick up the cost. The discussion is always the same- why should I have to pay for THEIR product? To date, society has decided that the manufacturer needs to pick up the tab, and we do.”

    I thought the beginning of this article affirms that Monsanto is responsible for their own product. I’m not sure what the issue is if you are willing to pay for the safety testing that the consumer feels is necessary. From what I understand, independent scientists are interested in doing studies as well, but are unable to acquire seed samples from Monsanto.

  39. John Q Says:

    I would like to point out, however, that Dr. Dan’s analysis shows why ANYONE doing research is reluctant to provide their raw data to the population at large.

    It is very easy for an untrained, misguided, or malicious person to pick out a single data point that is statistically insignificant and make an impressive but meaningless case out of it.

    I’d also like to echo another of Dr. Dan’s points: Tests cost money. One cannot refuse to pay for tests and then decry Monsanto for conducting (and paying for) the tests.

  40. Deborah Rubin Says:

    John Q Says:

    June 3, 2009 at 12:23 pm
    In particular, Dr. Pusztai said:

    “The next was that the transgenically expressed insecticidal protein did not only damage the aphid pests but also their natural enemies, such as the ladybugs.”

    I am unclear on this.
    *****************************

    That wasn’t really my particular point, John Q.

    My actual focus or point about the 2009 Pusztai interview concerns food safety: I question what Monsanto or anyone else knows (through the testing they have done on gm foods) about the unintended consequences of insertional mutagenesis. Is this issue addressed in the safety testing; if so, how? From the article and why I cited it:

    “What was particularly damaging for the validity of genetic modification was when we found that diets based on GM potatoes affected the growth, organ development, and immune reactivity of young rapidly growing rats. The final straw was when we showed that the damage originated not from the transgene and its expressed product but from the damage caused by the insertion of the transgene, probably due to insertional mutagenesis.

    Why is genetic engineering a risky technology?

    Gene insertion is a major problem. You cannot direct where the splicing of the genetic construct will happen. It is well known that when you insert a genetic construct into the DNA network of a plant, you create changes in that network. As a result, you will get changes in the functionality of the plant’s own genes. They may become more active or silent. The effects will be unpredictable and uncontrollable. It can sometimes cause irreparable damage to the genome. This is insertional mutagenesis.”

    _________________
    The ladybug info was incidental, not the point; however, I am not certain or suggesting it is without consequence environmentally. That aside, my point here is concerning the insertional mutagenesis with hope that Monsanto will speak to the research and risks involved…as well as the specifics in the AAEM position.

  41. John Q Says:

    Deborah, I think I see one potential area of confusion that I can address. You quote:

    “Gene insertion is a major problem. You cannot direct where the splicing of the genetic construct will happen….”

    This is very true, as far as it goes. But it misrepresents the process. “We” (the people who actually do this work) don’t take a single seed, or even a single cell, and insert a single gene. I don’t do the work, so I don’t know the details, but they take [a large number that I won’t even guess at because I’ll be wrong] of cells and attempt to insert the gene into ALL of them. Some get no gene. Some get multiple copies. Some are so damaged they die immediately. Some live but can’t reproduce. Of the ones that CAN reproduce, some produce “undesirable” plants, as you point out. Some express the gene in parts of the plants where they are not needed, like BT toxins in the leaves when “we” are trying to address root worms.

    So, before “we” even start testing for nutritional impact, the vast majority of these undesirable splicings have been eliminated. Then a whole battery of AGRICULTURAL fitness tests are run.

    And finally, THEN the nutritional/safety analysis begins. Because if a plant won’t grow, or won’t kill rootworms, or only sets seed on every 10th plant, there is no point in testing it (and paying for the test) for nutritional/safety impact. But I’m pretty sure your concerns ARE addressed in the safety testing.

    But the ladybug info IS part of the point: it is also why there is a concentration of heavy metals in large predator fish, and why DDT was accused of thinning the shells of bald eagle eggs. Pesticides cannot help but be transferred up the food chain. If “we” poison pests, SOME of those pests will be consumed by predators, and if the poison affects the predators, they WILL be affected. WHATEVER the pesticide.

    His report (or rather opinion) made it sound like DDT (or whatever) DIDN’T exhibit this behavior, but in fact “it” (some random pesticide) is worse, because “it” is not targetted only at the pest. It will indescriminately kill pests, predators, and other susceptible insects. That is what I was trying to point out. His “report” was misleading, whether intentional or not.

  42. Deborah Rubin Says:

    John Q Says:

    June 5, 2009 at 9:59 am

    But I’m pretty sure your concerns ARE addressed in the safety testing.
    ________________
    I would like to know how they are addressed, not a response that you are pretty sure they are. How does Monsanto address these concerns.

    Its the same sort of response you gave for this:

    John Q Says:

    June 5, 2009 at 8:37 am
    Deborah, sorry, I didn’t mean to make it appear by juxtaposition of the conversation points that I was accusing YOU of data misrepresentation. I was just trying to point out why Monsanto (and every other corporation doing research studies) is reluctant to release raw data. Dr. Dan, in the “How Safe is Your Food?” thread, which is at
    http://blog.monsantoblog.com/2009/05/19/food-safety-gm-foods/ (original post and also discussion), did a better job than I have of this.

    I also have no specifics as to the approval process (in ANY jurisdiction) of GM crops, but I DO know that testing IS done, and documented. I’m pretty sure this IS part of the regulatory process and also mandatory. I changed your deregulatory to regulatory because rest assured, it IS still highly regulated, even after a specific technology has been approved for commercial release.

    Dr. Dan alludes to this also in “How Safe is Your Food?”

    _______________________
    From what I have read, it is not mandatory for companies to release their data and safety studies. It is voluntary. The process is called “deregulation” by APHIS.

    http://attra.ncat.org/attra-pub/geneticeng.html

    Regulation of Transgenic Crops and Apportionment of Liability
    Much of the controversy over transgenic crops, both internationally and in the U.S., is in part a result of how the U.S. regulates transgenic crops. The federal government has determined that the commercial products of agricultural biotechnology are “substantially equivalent” to their conventional counterparts and that therefore no new regulatory process or structure is needed for their review and approval.

    Currently, three federal agencies regulate the release of transgenic food crops in the U.S.: the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA– APHIS), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA).

    USDA–APHIS: APHIS looks at how a transgenic plant behaves in comparison with its unmodified counterpart. Is it as safe to grow? The data it uses are supplied largely by the companies seeking a permit for release of the new crop. Under “fast-track” approval, a process in place since 1997, companies introducing a crop similar to a previously approved version need give only 30 days’ advance notice prior to releasing it on the market. According to the Wallace Center report, APHIS staff estimate that by 2000, 95 to 98 percent of field tests were taking place under simple notification rules rather than through permitting. (Wallace Center, 2001) The Office of Inspector General (OIG) report has called for much stricter tracking—in light of the industry shift to industrial and pharmacrops.

    EPA: The EPA regulates the pesticides produced by transgenic crops, such as the Bt in Bt corn and cotton. It does not regulate the transgenic crops themselves. In contrast with its regulation of conventional pesticides, the EPA has set no tolerance limits for the amount of Bt that transgenic corn, cotton, and potatoes may contain. (Wallace Center, 2001)

    FDA: The FDA focuses on the human health risks of transgenic crops. However, its rules do not require mandatory pre-market safety testing or mandatory labeling of transgenic foods. Initially, the U.S. regulatory process for transgenic food crops required product-by-product reviews. Now, however, to simplify and speed up the process, new products can be approved based on the experience gained in reviewing earlier products. According to the Wallace Center report, the implication is that “some crops might be approved, or disapproved, without actual field testing.” (Wallace Center, 2001) The regulatory process, in fact, may not answer most questions about the environmental and human health risks of commercial production of these crops. (Advisory Committee on Biotechnology, 2003)

    Central to the policy of substantial equivalence is the assumption that only the end product of transgenic technology is of concern—not the process of genetic modification. Canada has adopted a similar approach. Europe and other U.S. trading partners, however, have taken a more conservative approach. They focus on the process of genetic modification—the source of many of the environmental and human health risks of greatest concern.

    How these different approaches play out in reality can be summed up simply. The U.S. and Canada assume a product is safe until it is proven to carry significant risk; the European Union, which follows the “precautionary principle,” assumes the same product may carry significant risk until it can be proven safe. The science used by the two approaches is not fundamentally different. The difference is in the level of risk the different societies and political systems are willing to accept. (ESCOP/ECOP, 2000)

  43. brian Says:

    If you all are so concerned about this, then why did you pressure Fox News into cutting the story about the well-researched and documented negative effects of rBST on humans in Florida? When there is solid evidence to the contrary, it seems that Monsanto uses its vast array of lawyers, researchers, marketing department and political lobbyists to make that evidence somehow remain silent.

    For those not familiar: This was to run on Fox News in Florida, but the reporters were eventually fired because they were told they either had to lie or would lose their jobs. Reporters sued Fox News because they were being told to lie. Fox News won the case because they had more money and lawyers, who convinced the judge that in fact Fox News is allowed to lie if they want to so there was no basis for a suit.

    Fox News and Monsanto use this outcome to say they did nothing wrong, but that cause and effect relationship does not exist. The outcome only means that news outlets are allowed to lie.

  44. John Q Says:

    Brian, I am NOT familiar with the events you describe, and I hope you’ll excuse me if I decline to take your statements at face value. Do you have any independent reputable documentation of your allegations? I HAVE heard of something similar, but the explanations provided were quite different, so I’m not sure it was the same event.

    Because, besides your claims against Monsanto and Fox News, you are also calling in to question the validity and effectiveness of the entire American Legal System.

  45. jg Says:

    Perhaps they were fired because the infomation in the report was false and there was no well -researched documented evidence on the negative effects in humans. Perhaps the ex-FOX reporters were being asked to tell the truth. Perhaps the reporters wanted a sensational story at the expense of others. Why do you assume the reporter are not at fault?


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