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The Skinny on the Seralini Safety Study

soapyhands

By Dr. Dan

It’s time for a blunt discussion on Seralini’s laboratory studies on placental and breast cancer cells.

If you put a detergent of any sort on cells in a petri dish, the cells get sick (and will die if you get the concentration high enough or recover if you remove the detergent soon enough).

Therefore, Seralini’s choice of cells was not biological but, I believe, political. Reproductive tissue cells were chosen, I submit, so that the author could scream, “endocrine disruptor.” Any other cell line would have given essentially the same result–but would not have been as politically useful in terms of gaining media coverage and elevating public concern.

Similarly, he chose to measure cellular function by sex hormone production. He could have measured almost any cellular function–but again, this choice was useful from a political rather than scientific perspective. He has not demonstrated endocrine disruption–he has demonstrated that detergents injure cells using endpoints chosen for apparent political convenience.

Roundup formulations contain surfactants (detergents) to help the active ingredient penetrate the waxy cuticle of the plant. The same is true of virtually any herbicide formulation. In the case of Roundup formulations, the active ingredient has such a low degree of cellular toxicity that it is actually the detergent that injures cells in culture.

Baby shampoo, liquid bath soaps, shampoos, dishwashing soaps, laundry detergents and a slew of other product we use everyday also have detergents in them. We squirt them in our hair, rub them all over our skin, soak our dishes in them and wash our clothing with them. Over 99 percent of our exposure to these types of materials comes from these direct and indirect human applications–NOT from pesticide use in general and certainly not from Roundup formulations in particular.

And if you test the types of surfactants and detergents used in shampoos and soaps guess what–they injure cells too.

But what about plant-based detergents? You can go buy plant based detergents if you want. But, so what? You can make a detergent by chemically processing any kind of fat from plants or animals. But fatty acids are fatty acids–whether from animals of plants, and polyethoxylated fatty acid detergents (POEAs) have the same structure and the same toxicity no matter what the source of the fat. (If you are vegetarian and wish to get your polyethoxylated fats from non-animal sources, I can respect your personal decision as to source–but don’t kid yourself about the chemisty or the toxicity).

These kinds of detergents are common in our everyday environment, mostly, as noted above, NOT from pesticides- and with no apparent harm. Why? Last time I checked, we did not consist of naked, unprotected cells living in protein-free media at the bottom of a petri dish. Whole organisms have a wide variety of defense mechanisms or barriers in place–like skin or metabolic processes.

In my mind, Seralini’s data are worthless and irrelevant for safety assessment at best. At best, the data are misleading to those who have not sorted through the politics and emotion to get to the science, or do not have the scientific background to do so.

What I find most disturbing about the cell lines chosen and the endpoints measured–and the way in which the results are positioned–is that they were clearly undertaken by the investigator for maximum political ruckus, not optimum scientific understanding.

Maybe the public should expect more from investigators like this one. But that is not for me to determine.

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 "The Skinny on the Seralini Safety Study"

  1. We squirt them in our hair, rub them all over our skin, soak our dishes in them and wash our clothing with them.

    Which is why we need to educate people out of using them. Baking soda, vinegar, honey, vegetable oils, salt and water is all you need to clean both yourself and your house.

  2. And while we are at it lets stop driving cars and using electricity. I like my way of life, thank you. You go right on and enjoy your way of life and ill enjoy mine.

  3. Mmm. They do not, however, cause harm to the environment in toxic residue. Nor do they act as surfactant. I wouldn’t drink plain vinegar, no. (I know it wouldn’t kill me if I wound up ingesting it, though.) I will use 1 tablespoon apple cider vinegar in water to rinse my hair after a wash.

    21st century, I don’t doubt the facility of your everyday life is pleasant to you now. If you want to waste your money on things you don’t need, you go on ahead. Just don’t get ******** when someone derides it. There is no need to be quiet.

    (EDITORS NOTE: Word omitted because of offensive nature)

  4. And Ryan, please don’t assume people haven’t done their research before making their own choices.

  5. clarification: there is no need for the critical to be quiet. Especially on the official blog of an agrochemical company.

  6. r – it could be argued that salty water causes massive environmental damage, particularly to agricultural areas, I’d assume that overuse of baking soda or vinegar would also have unpleasant results environmentally in terms of shifting soil and water pH away from normal ranges – for most detergents used I’d guess that ingestion problems would be similar although dose dependant – too much vinegar would undoubtedly cause nausea and could be fatal at high levels, too much salt can be damaging, or can kill, too much vegetable oil similarly would cause nausea or health problems, ingest too much honey and you are well on your way to joining the ever growing ranks of type II diabetics etc etc.

    Likewise industrially manufactured detergents will have dose dependant issues associated – I have absolutely no fear whatsoever of inadvertently ingesting a little bit of soap, shampoo, body wash or whatever – although I wouldnt go so far as to down a bottle of head and shoulders.

    The point being that in either case here the exposure levels anybody other than a veteran shampoo chugger are likely to experience are not likely to be anywhere close to dangerous, and the possible 99% exposure from other detergents quoted in the article) due to residual detergent in food is clearly not cause for concern.

    I’d bet that when exposed to pretty much any of the substances you mentioned though that unprotected cells grown in culture would see adverse effects (to return to the point of the original blog and the relative absurdity of attempting to make whole organism safety assumptions based on unprotected cell studies) – vinegar and baking soda would likely disturb the pH of the growth medium to an extent that you’d see a lot of cell death and metabolic changes, changing salt levels equally could lead to a lot of problems (particularly in terms of osmotic pressures, and probably in terms of effecting electrochemical gradients in the cell membrane), honey would likely also cause osmotic issues and probable metabolic changes due to increased availability of carbohydrates etc etc.

  7. Hmm it appears I missed half a sentence above.. the 3rd paragraph should read more like

    The point being that in either case here the exposure levels anybody other than a veteran shampoo chugger are likely to experience are not likely to be anywhere close to dangerous, and the possible less than 1% extra exposure (stealing the greater than 99% exposure from other detergents quoted in the article) due to residual detergent in food is clearly not cause for concern. (I think I may have been defeated by html and greater than/less than signs…)

  8. Vinegar and salt will ABSOLUTELY cause environmental damage. The act of pickling would say both are effective microbicides, or killers of small, unprotected cells.

    Some plants require an alkaline environment and would be severely injured or killed by vinegar. And a standard “non-chemical” herbicide is boiling water and salt to kill weeds, especially in concrete cracks. While the Battle of Carthage may be apocryphal, look up the term “Salting the earth”. It was used as punishment in several medieval countries.

    Finally, you are welcome to deride any and everything I say, but I object to your choice of terms for how you suppose it will make me feel.

  9. Yep, they make good antimicrobial agents and herbicides too, John Q, which I unfortunately left out of my comments. You seem to believe the only reason many of us choose to use, say, vinegar is simply that we believe it to be gentler, when in fact there are a variety of reasons to using a given substance, the number of possible applications being a major motivation.

  10. What actually are the toxicities of the glyphosate formulations currently used on our food crops? Are there any synergistic effects noted in the atrazine, etc, mixes? Do roundup ready plants metabolize atrazine the same way conventional crops do? What about other pesticides?

    Regarding glyphosate toxicity testing, has the classification of Roundup changed since this court case?

    http://www.thefreelibrary.com/Toxicity+tests%3a+%22inert%22+and+active+ingredients.(Perspectives%2f…-a0137967170

    The findings of Richard et al. (2005) are an important addition to our understanding that the health and environmental effects of formulated pesticide products are not fully reflected in tests conducted on the active ingredient(s) alone. It has been long known that the adjuvants (commonly and misleadingly called “inert” ingredients) may be toxic and may enhance or supplement the toxic effects of the active pesticidal ingredient.

    In the case of glyphosate-containing products, this phenomenon was well demonstrated in the data submitted to the (EPA) by the registrant (Monsanto), and summarized by the U.S. EPA in the Reregistration Eligibility Document (RED) for glyphosate (U.S. EPA 1993). For example, based on the registrant’s own tests of acute toxicity to freshwater fish, the U.S. EPA classified technical grade glyphosate as “slightly toxic” to “practically non-toxic” and formulated products ranged from “moderately toxic” to “practically non-toxic.” Tested alone, the surfactant adjuvant (identified as “inert”) was “highly toxic” to “slightly toxic.” Similar differences were reported in tests of acute toxicity to freshwater invertebrates.

    Based in part on the data in the glyphosate RED (U.S. EPA 1993), State Attorney General’s office successfully pursued an action against Monsanto in 1996 (Attorney General of the State of New York 1996). At that time, Monsanto was making advertising claims about the toxicity of the Roundup products based on data from tests on the active ingredient alone. Such claims are scientifically unfounded and inherently deceptive. The Attorney General’s action was facilitated by the availability of at least some limited information about the inert ingredients and their toxicity. That same sort of information enabled Richard et al. (2005) to conduct their study.

    Unfortunately, that is not always the case, and for many pesticide products, little or no information about the identity of inert ingredients is publicly available. Registrants are generally required to conduct acute toxicity tests on formulated products, but they traditionally conduct chronic toxicity tests on the active ingredient alone. Even when formulated products are tested, the identity of inert ingredients is rarely revealed in the open literature, publicly available regulatory documents, or product labels. Therefore, independent research is stymied, and the public is ill-informed in the marketplace.

    The author is the chief scientist in the New York State Attorney General’s Environmental Protection Bureau and was actively involved in the 1996 action against Monsanto.
    **************
    Following this comment is a response by Seralini :

    http://www.thefreelibrary.com/%22Inert%22+and+active+ingredients%3a+Seralini+responds.(Perspectives%2f…-a0137967171

    Surgan raises interesting points in his analysis. This interest has been confirmed by reactions of agriculture authorities all over the world after publication of the article by Richard et al. (2005).

    Indeed, scientific problems do exist in the registration of pesticides today, when chronic tests are conducted with the active ingredient alone–which is generally the case. First of all, chemists from companies may work hard for several years to find the right formulation that best amplifies the effects of the active ingredient, his formulation will allow penetration and stability and/or bioaccumulation of the active ingredient within plant, fungi, or insect cells, for instance, to reach the best toxicity. If there are any side effects in other animal or human cells, these will be also amplified by adjuvants, and thus not measured in chronic toxicity tests with the active ingredient alone. The active compound absorption by skin is generally calculated in the presence of formulated adjuvants, but this is clearly a short-term study and not sufficient to detect, for example, endocrine disruption or carcinogenesis, possibly promoted in vivo by the described synergy. This should even necessitate further care in case of the use of formulated products such as glyphosate-based herbicides on tolerant, edible plants.

    As a matter of fact, most genetically modified crops have been modified and selected only to tolerate high-formulated herbicide absorption, but the plants are not submitted for registration requiring chronic toxicity studies involving long-term feeding of animals. Moreover, in the case of environmental pollution, active pesticide ingredients may encounter detergents or other lipohilic xenobiotics with comparable effects other than those of their own adjuvants, for instance, forming microvesides to penetrate the cells. These combined effects should also be taken into account in authorized thresholds of pollution in order to avoid effects on wildlife or humans.

  11. More info from the Free Library:

    http://www.thefreelibrary.com/Unidentified+inert+ingredients+in+pesticides%3a+implications+for+human…-a0160559034

    “Numerous studies indicate that inert ingredients may enhance the toxicity of pesticide formulations to the nervous system, the cardiovascular system, mitochondria, genetic material, and hormone systems. [with which I believe you concur above]

    Peixoto (2005) found that a glyphosate
    formulation caused a significant reduction in the activity of rat liver mitochondrial respiratory complexes in vitro but that glyphosate alone had no effect.

    Pesticide formulations have proven to be more potent genotoxins than active ingredients alone in a variety of test systems. In vitro treatment of human lymphocytes with glyphosate and a glyphosate formulation resulted in a significantly higher rate of induction of sister chromatid by the formulated product (Bolognesi et al. 1997). Both the formulation and glyphosate increased micronucleus formation in mouse bone marrow; the increase was “more pronounced” with the formulation.

    Inert ingredients may enhance the reproductive toxicity of active ingredients. Both the herbicide glyphosate and a glyphosate formulation were toxic to human placenta cell cultures (Richard et al. 2005). However, the formulation was significantly more toxic than glyphosate alone; the median lethal dose for the formulation was half that of the active ingredient.

    Several reports demonstrate disruption of endocrine function by inert ingredients. In one study, a glyphosate-containing herbicide formulation inhibited progesterone production in vitro in mouse Leydig cells, but glyphosate did not (Walsh et al. 2000). Richard et al. (2005) noted that a glyphosate formulation inhibited the activity of human placental cell aromatase, which converts androgens into estrogens. Again, glyphosate alone did not inhibit the activity of this enzyme.

    Inert and active ingredients can interact to diminish the protective efficacy of both clothing and skin, reduce the efficacy of washing, and increase persistence and off-target movement of pesticides.

    Consistent with our growing awareness of the complexities of the toxicity of mixtures, it is no surprise that pesticide formulations act differently than active ingredients alone. As early as 1988, the National Research Council (NRC 1988) concluded: “Mixtures that are of particular concern include chemicals generated in fire, hazardous wastes, pesticides, drinking water, fuels and fuel combustion products,” adding that “toxicological studies of mixtures are essential for estimating human risks.”

    More recently, the Agency for Toxic Substances and Disease identified chemical mixtures as one of six priority areas in public health research (de Rosa et al. 2004). ”

    ++++++++++++++

    Dr. Dan, do you consider these data all worthless and irrelevant for safety assessment?

    Are the entire Roundup mixtures tested for toxicity? Are the crops, together with the absorbed/metabolized Roundup in doses it is generally applied, tested for toxicity in feeding studies?

  12. Deborah – I’m sure Dr.Dan will have a somewhat more explicit response however I’d point you to

    http://www.monsanto.com/products/techandsafety/herbicide_scipubs.asp

    For our current information (and links to the scientific literature/EPA studies and findings etc) around glyphosate – in the two that I took the time to look through it appears that both the active ingredient (glyphosate) and the final product were both tested.

    On the relevance of the safety studies – I’m sure that at least some of those quoted (again havent had time to go through them in any detail) probably are relevant when viewed with the rest of the available data, others probably not so much – to return to the point of Dr.Dan’s original posting – in vitro studies are probably generally a lot less relevant than in vivo studies when assessing toxicology (most of the cited reports in your second post are in vitro studies and therefore prone to similar issues to the seralini study, although possibly to a lesser extent depending on the cell types used (sure Dr.Dan would have a better handle on this also))

  13. Now really, are you going to clean your baby with vinegar and salt? Or are you going to use honey and vegetable oil. I’m sorry- but soap is what you clean a baby with. I am a father of 4 and a board certified pediatrician in 2 countries and I think I have some vague idea how to clean a baby.

    Salt and vinegar works on many things. Try it on a penny- end up with a bright shinny copper surface. Watch the little bubbles come off. NaCl + acetic acid gives you a nice mixture of sodium acetate and hydrochloric acid.

    Want to clean your baby with sodium acetate and hydrochloric acid??? (AAAHHHH…. CHEMICALS!!!)

    “Horticultural vinegar” is 25% acetic acid and will cause severe eye and skin injury. Salt has an LD 50 less than half that of glyphosate and not a lot different from the surfactants (in PURE form… not diluted.

    I have no problem with these variants for cleaning surfaces- although I think you will find they are mostly unsatisfactory. Numismatists have cleaned coins with salt and vinegar for as long as I can remember… used to do it as a kid.

    As far as seriously cleaning people, clothing, and dishes- you’ve GOT to be kidding.

  14. Deborah-

    Last go round, we did the applicablity of the Hill Criteria…. now we can do synergy. Another year or so and we will have the whole core curriculum in toxicology covered!!

    There are a variety of issues with teh various studies you have cited, but I will stick to the main point. Since the surfactants are indeed generally more toxic than the active ingredient (which has no target in mammals and has what I would consider to be minimal toxicity), it should come as NO SURPRISE that formulated products containing surfactants and glyphosate together are more toxic than glyphosate alone.

    When one sees this pattern, there are two (not mutually exclusive) possible explanations: 1) that the surfactant is toxic or 2) that the surfactant has increased the effective toxicity of the glyphosate in some way. This might, for example, be due to increased absorption or some other interaction at the target site, decreased excretion, etc.

    What I would tell you is that the effects in these studies (whether they are correctly done or relevant is another matter) are generally consistent with the expected effects of surfactants and are not seen in animal studies of the active ingredient, even with IV administration, which avoids issues of altered absorption.

    I cannot categorically exclude the POSSIBILITY that other ingredients MIGHT have some slight syntergistic effect- meaning that they act together to produce more than the sum of the expected toxicity of the individual components.

    HOWEVER- to date I have seen no even remotely convincing data to suggest an actual synergistic or interactional effect. I have discussed this issue at length with a number of respected medical toxicologists over the last decade, and they have generally agreed that the data are consistent with an effect of surfactant and do not prove the existance of a synergistic effect.

    dag

  15. As I am not an expert in advertising law, I will make only limited comments on the NY State case, which was the handiwork of that pillar of moral rectitude, Elliot Spitzer- a reminder that the higher one climbs on the purported moral high ground, the further one can fall and the more one can get hurt…..

    This matter was not about interpretation of science but about potential interpretation- or rather misinterpretation- by the general public- of wording and other visual portrayals under advertising law, specifically as relates to environmental safety. Monsanto came to an agreement with the NY Attorney General as to precisely what wording would and would not be acceptable in the State of New York.

    It seems that the other 49 states had no problem… at least not that they brought to our attention, and to the best of my knowledge we have continued to abide by the agreement on wording to date.

    This area has been a sticky wicket for some time as the legal standard (again, I am not a lawyer… so this is a doctor’s understanding… and would you like your lawyer to operate on you??) is whether phrasing may be misleading to an ordinary person. It does not need to be misleading to all people or even the majority. As you can imagine, wording that is so precise as to be not misleading to anyone is hard to come up with, it is not clear who the ultimate arbiter of the language should be, and language that is clear to one person may seem potentially misleading to another.

    About the best one can do is to come to some agreement that both parties think is acceptable and move on- which is what both sides of this matter did.

  16. Dr. Dan Says:

    June 30, 2009 at 3:01 pm
    As I am not an expert in advertising law, I will make only limited comments on the NY State case, which was the handiwork of that pillar of moral rectitude, Elliot Spitzer- a reminder that the higher one climbs on the purported moral high ground, the further one can fall and the more one can get hurt…..
    ********************
    In my mind, the involvement of Elliot Spitzer in the case does not change the facts of the case. His morals are his own, as are yours and Monsanto’s.

  17. Dr. Dan Says:

    June 30, 2009 at 2:39 pm

    What I would tell you is that the effects in these studies (whether they are correctly done or relevant is another matter) are generally consistent with the expected effects of surfactants and are not seen in animal studies of the active ingredient, even with IV administration, which avoids issues of altered absorption.
    ++++++++++++++++
    I don’t see how that diminishes the relevance or worth of the findings. Roundup contains the surfactants. Are you saying that the surfactants, as opposed to glyphosate, in Roundup cause the effects found in the research of Seralini and others?

    That possibility is still very alarming since Roundup formulations–containing the surfactants–are sprayed on such a large percentage of our food crops, animal feed crops, our lawns, and over such a large area of land in general.

    How is altered absorption ruled out by showing that the isolated active ingredient does not produce the effect? How are endocrine and carcinogenic effects of the active ingredient in formulation ruled out? I’m not understanding how we know glyphosate is not part of the equation?

    And could you tell me if synergistic/interactional effects involving glyphosate and atrazine and the other pesticides used in Monsanto formulations have been researched? Are the studies available?

    Do Roundup Ready plants metabolize atrazine and other pesticides like conventional plants do? Are studies available to demonstrate this?

    Are Monsanto’s feeding or toxicology studies done with RR crops that are treated with Roundup in all of its various formulations?

  18. Yes, I am saying- and have said repeatedly both here and elsewhere that one sees predominantly or entirely surfactant mediated effects in most of the in-vitro system.

    Glyphosate is a small amphotertic molecule which has an apparent volume of distribution equivalent approximately to body water. On the basis of this information and the basic physico-chemical properties of the molecule, one would expect it to enter readily into cells in in-vitro systems. These systems HAVE no absorption component equivalent to the skin or GI tract, glyphosate should penetrate readily into cells, but one sees little or no toxic effect of glyphosate itself even at very high concentrations. While the surfactants might enhance glyphosate penetration into cells to some degree, it is highly unlikely that this would account for the observed toxicity because one does not see similar effects even with massively higher glyphosate concentrations. You would have to argue that cells are nearly impermiable to glyphosate and that the surfactant increases absorption by some 100-fold to account for the results seen in the most recent work by Seralini. I do not believe this is compatible with what is known about glyphosate and consider the explanation to be highly unlikely if not virtually impossible.

    WHY is this alarming??? I have already pointed out that for surfactant use, our exposure is 99% or more the result of shampoos, soaps, and detergents in houshold use. Another commenter pointed out that this is precisely why we should be concerned…. so let me get this right:

    99% of your surfactant exposure comes from products you happen like and use. Less than 1% of comes from products that (for whatever reason…) you do not like. THEREFORE YOU WORRY ABOUT THE 1% WHEN THE 99% HAS NO APPARENT EFFECT??? This is not science… it is not even a rational thought process. This is just plain nonsense.

    Plants do not significantly metabolize glyphosate (AMPA forms mainly in the environment). There is metabolism of atrazine. Glyphosate and atrazine do not share the same target in plants. As glyphosate is not metabolized, it cannot be competing for metabolic sites with atrazine. Atrazine is used primarily for weed control in grass crops, which would be killed by glyphosate. Glyphosate tolerant grass crops (Roundup Ready Corn) were developed in part because you COULD AVOID ATRAZINE by using a more toxicologically favorable (no cancer issues, no transport issues) molecule instead. While this does not entirely preclude the use of these chemicals at the same time, this is not expected to be a common approach in corn, and even if used together, there is no rational basis to believe they would interact.

    I am not aware of interaction studies of glyphosate and atrazine in plants or other organisms. The mixture issue is a topic of discussion at the moment, but has no obvious answers when you consider the hundreds of possible conbinations of chemicals, and thousands of possible non-chemical interactions in the environment.

    The hypothetical giant experiment combining everything with everything else in all combinations of 2 or more materials cannot be done. It cannot be done with foods either- how do you know that if ham is safe and cheese is safe, you can eat a ham and cheese sandwich?? What happens when you eat celery (contains carcinogens) with brussles sprouts (which alter metabolism via cytochrome p-450)?

    There are ENDLESS hypothetical interactions. With chemical exposures we take two approaches- acute testing of formulated products (to see interactions between actives and inerts) and the application of large uncertainty factors below physiological effect points, which serves to minimize the occurence and/or magnitude of interactions and provides a margin of safety in the event that modest interactions do in fact occur.

    dag

  19. Dr. Dan,

    I will digest what you have said above about AMPA, etc.

    I am still wondering if the feeding trials done with RR corn and soy are done using crops that have been treated with Roundup in its various formulations at the typical application rates over time.

  20. Dr. Dan,

    Would you please comment on this press release from CRIIGEN on July 2, 2009?

    PRESS RELEASE – July 2nd 2009
    HERBICIDES ROUNDUP DISRUPT SEXUAL HORMONES
    Prof. Seralini’s group from CRIIGEN in the University of Caen, in collaboration with Pr.
    Chagnon’s group from the University of Dijon, have just published a new discovery, after
    having demonstrated Roundup toxicity at infinitesimal doses in particular in umbilical cord cells from newborns. At very low levels, for instance 800 TIMES LESS THAN ROUNDUP RESIDUES AUTHORIZED IN SOME GMOs FOR FEED in United States [emphasis mine], this kind of herbicide for a formulation
    sold in drugstores prevents the action of androgens, the masculinizing hormones. Then the
    action and formation of estrogens are also disrupted. The DNA damages in human cells begin
    around this level. These effects explain disturbing results of animal experiments and in
    human epidemiology. It is thus proposed to examine in regulatory instances the classification of Roundup and other glyphosate-based herbicides as reprotoxics and endocrine disruptors.

    These phenomena have been underestimated up to now because pesticides factories present in
    majority to authorities’ studies with Glyphosate alone, however the commercialized mixture is
    a lot more active.

    [This translation from the French is a bit confusing, but I believe it means the majority of studies presented examine the effects of glyphosate alone, instead of in formulation.]

    The study is published by the end of June 2009 in the international scientific journal
    Toxicology by Gasnier et al.
    Contact: Prof. Gilles-Eric Seralini, criigen@unicaen.fr http://www.criigen.org
    ———————–
    Since the residue on and in our food is from roundup formulations and we are eating this residue, why shouldn’t we be alarmed?

  21. Sounds like the same unprotected cells and surfactants we’ve already seen and addressed.

    I have to wonder, has Prof. Seralini also investigated organic castile soap and baby shampoo using the same methodology? What about BHA and BHT? Or is he only tilting at the Glyphosate/RoundUp windmill, because it gets him more press?

  22. Have we seen the same results from baby shampoo and castille soap formulations diluted to the same concentrations as the Roundup in the studies?

  23. Deborah – to partially answer the question on whether safety studies on RR corn used corn treated with glyphosate at least in the case of

    http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T6P-4BY3M6Y-6&_user=1631782&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=949372888&_rerunOrigin=scholar.google&_acct=C000053988&_version=1&_urlVersion=0&_userid=1631782&md5=75353616e5e294f091890bc11b4d2800

    (hopefully the link works… if not look for Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant corn
    B. Hammond, R. Dudekb, J. Lemena and M. Nemetha)

    the answer is yes, I would assume, although havent had the time yet to check, that this would generally be the case.

    Why shouldnt we be alarmed? The weight of scientific evidence still points to glyphosate useage as safe for humans.

    http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WPT-45C0WDC-1&_user=1631782&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=949376731&_rerunOrigin=scholar.google&_acct=C000053988&_version=1&_urlVersion=0&_userid=1631782&md5=445355b184894afa6fe9fd8b16ad1a35

    (if this link fails look for reviews of glyphosate safety data – a literature review is generally better than a single article for showing current scientific consensus)

    and these in vitro studies with their downfalls as stated in the original posting should not be cause for concern (although admittedly they do make for some good sensationalist anti-GM propaganda)

  24. Are you asking if we HAVE, or if we WOULD? They are very different questions, and expose the fallacy behind Dr. Seralini’s study.

    I think (without any justification) that we WOULD see similar results, if anyone (Prof. Seralini???) was interested in DOING such a “non-sexy” study.

    But people aren’t wailing and gnashing their teeth to have organic castile soap tested to the n+1th degree.

  25. Ewan, I found the following quote on your link:

    “Roundup herbicide was applied to Roundup Ready corn plants during the growing season at commercial rates of application”

    Which I read to say Monsanto’s Glyphosate formulation was used in the test. I have to wonder whether any of the Chinese formulation of Glyphosate has been so tested? Presumably they are using a different mix of surfactants, etc.

  26. I do thank you for the study referencing the crops treated with Roundup and will read them.

    Ewan Ross Says:

    July 6, 2009 at 10:24 am
    (– a literature review is generally better than a single article for showing current scientific consensus)

    —————-
    Consensus is not necessarily correct and comparing the individual studies oneself yields a better investigation of the opposing outcomes of similar studies–which in my mind points to a problem some where of some sort. Sometimes useful, Meta-analyses are a good way to homogenize the results and blur the lines. They have many weaknesses and are easily manipulated.

    General scientific consensus used to be required in court for expert testimony, but since Daubert, it is no longer the sole recognized critieria for scientific expertise. Consensus can be and often has been highly over-rated and wrong. Think back through history….and now science is advancing so rapidly. Consensus is not so easily defined.

    John Q Says:

    July 6, 2009 at 11:46 am
    Are you asking if we HAVE, or if we WOULD? They are very different questions, and expose the fallacy behind Dr. Seralini’s study.

    I think (without any justification) that we WOULD see similar results, if anyone (Prof. Seralini???) was interested in DOING such a “non-sexy” study.
    ————————–
    John, I am asking if ANYONE HAS. Dr. Dan seems to be implying Roundup is no more dangerous than baby shampoo. What does he base that on? You all seem to use the word “sexy” a lot when describing criticism of your products. Is that psychologically evocative in PR? Lots of undertones and overtones embedded in the accusation? It almost screams of infidelity to the sacred marriage of Man, Woman, and Science, eh? I’ll leave that twisted triangle there.

    Would you bathe a baby’s head in Roundup? You seem to be insinuating there would be very little difference between that and Roundup…. I bet you would never consider the thought! Because it is preposterous!

    But, I do thank you for the study references and will read them. And compare it to what else is out there.

  27. Deborah – I have to say I dont agree with your assessment of consensus – consensus is how science, as a body of evidence describing how the world works, operates – looking historically there arent truly any major shifts in “scientific truths” without there being either a sudden injection of a massive amount of evidence (Darwin springs to mind here, although arguably all subsequent scientific work in the area of evolutionary biology can be seen as additional consensus material) or no previous scientific framework in the area (Galileo springs to mind here, as the prevailing world (or euro…) view was an ideologically imposed construct and not something which was evidence based)

    Repeatability and general consensus are cornerstones of good science, considering the vast repeatability of in vivo studies of glyphosate/roundup safety over 35 years (I recall 2 other reviews I spotted in my search, one I believe from the 80′s and another from the 70′s) which amount to I would guesstimate (science at its best…. =p) over 300 scientific papers it seems somewhat premature to suggest overturning this vast body of evidence based on studies which to a veteran toxicologist (albeit a partisan one) are worthless and irrelevant for a toxicology study (I havent been able to find an actual publication for the Gasnier study you posted info on – perhaps it is forthcoming, and hopefully not another Putzai type press release which subsequently only sees the light of day in non-peer reviewed format)

  28. I was finally able to find an alternative link to the safety assurance study of 13 weeks. The link given was not free. First off I noticed it is a Monsanto study. Next, I’m wondering why it was designed using mature rats? Is that the best method to look for developmental differences?

  29. While the rats in the study were sexually mature you’ll notice that there is an approximate 200% increase in body weight across all groups for the males and an approximate 100% increase in body weight for the females across the course of the investigation – a range in which I would assume developmental differences would become apparent. (I’m also guessing that the age range in which most development takes place would not be ideal for a feed safety study as during this age range maternal milk and not external food would be the prime source of nutrition)

    Apologies for the link not being free… I try to supply links and names for articles as its hard to remember which journals/sites you need to subscribe to and which are more open. (suffering the same issue myself on a recently published review of GM food safety)

  30. Responses to a few of the questions above:

    I cannot recommend shapooing a baby with Roundup. It is not in accordance with the EPA approved label and would be a violation of federal law.

    HOWEVER- the skin irritancy of Roundup was compared to baby shampoo and other materials many years ago (about 1986) by Maibach et al. and they are (unsurprisingly) of similar irritancy (RU contains 10-20% surfactants in a typical concentrate, baby shampoo is close to 100% surfactant. Further, there are a limited number of suicide attempts with shampoo and guess what- people die!! The only reason we don’t see more cases is probably that people do not expect to get much of an injury or response from others by ingesting shampoo.

    If you did wash a baby’s head with Roundup, it would probably work fine…. NOT recommended.

    The studies done with soybeans use standard production methods and hence Roundup Ready soybeans were in most instances treated with Roundup. This results in residues already known to be in a range well tolerated by the experimental animals. This is routinely recorded with the individual experimental protocol.

    I have little more to say about the Seralini press release. I have seen the publication, which is a far better source of the scientific information. The press release adds no useful data. I would only note that- of the materials sold in drug stores, Roundup is hardly the toxin I would be worried about- even over the counter, let alone by prescription- not to mention drain cleaners, rust removers, and the like. I fail to be terribly impressed by the fact that the surfactant is more toxic than the active ingredient. We know that when we formulated the product, and it has never been a secret.

    We did not study baby shampoo per-se, but rather a variety of surfactants, including those used in consumer products. I have no doubt whatsoever that baby shampoo will do the same thing as POEA- the only question is what precise concentration would be needed.

    Finally, while I am not a lawyer, I am a forensic toxicologist. Daubert won’t help you much here. It does not determine truth- only admissability in a court of law. Some of the criteria utilized (essentially the Hill criteria) are certainly applicable to scientific assessment- but the purpose of Daubert lies in a very different realm.

  31. For people who understand french, the “Afssa (Agence Française de Sécurité Sanitaire des Aliments), the french food safety agency recently published (march 2009) a statement concerning the séralini’s “study” mentionned above.
    http://www.agref.org/XLEGISLATION%20GLYPHOSATE.pdf
    The methodoly and the material used for the study is not appropriate. He starved the cells because he remove the serum for the chimical treatment. The pH is too low for the cells, the cells are cancer cells so alreday disturbe… The cells died most likely because of membrane desorganisation and osmolarity problems… People can maybe try to use automatic translation system to understand the report (it’s not a problem for me, I’m french). There is no doubt about the complete absence of biological relevance of this work for safety issue. What was amazing in France is the “full access” Séralini got to the news papers to sprayed his propaganda. He even got acces to the 20h00 TV news in the evening. Journalist have no knowledged in science and just repeat like a parrot the “scary” news…. Imagine a herbicide which is a threat for human embryo!! This is “holy bread” for a journalist this kind of stories… and it is anti-GMO, so they like it even more because it is what french people want to hear: only news that fit with their already made opinion. By the way, don’t expect GMO to be accepted in Europe before at least 10 to 20 years, the mind of pepole is already “formated” and brain wash by the journalists that keep repeating the propaganda of green extremists. It’s so easy to scare people… and journalists like it so much. It so much easier to creat emotion instead of information, and people also like to be scare. Anyway, when some journalist try to let real scientist giving a rationnal opinion about gmo they are immediatly blame and suspected to be paid by the “big nasty american monsanto compagny” who wants to poison us with his “evil MON810 corn”. In USA the creationism is quite developped but in France and other countries in Europe the obscurantism is also growing quite fast these last years. There is a bigger and bigger rejection of science.
    For Deborah Rubin, I invite you to read this paper about the toxicity of sodium oleate, a soap component (natural compound) on the paramecia (unicellular alguae).
    http://ev214.ev.ntu.edu.tw/17-6/J.%20Environ.%20Eng.%20Manage.,%2017(6),%20377-383%20(2007).pdf
    You will notice the toxicity of soap is actually quite similar to the POEA, both in the range of the ppm concentration …. of course, cells dont like detergents. There are also some references in the Afssa reports.
    If you still have doubt about the low quality of Séralini’s work, just look at his last paper publish last june (same low quality work with hepatic cells in which he pratice a lot of auto-citation of his previous work… ridiculous). It seems you like to pay attention to the funding of a study, so pay attention to the funding source you will notice he’s paid by the “fondation Denis Guichard”, an organistion of illuminated people
    http://fondationdenisguichard.com/
    He also got funding from “Léa Nature Group/Jardin bio” (some organic organisation) and the most funny, from “Sevene Pharma”, an homeopatic compagny for whom Séralini developped pills to “depolluted” your organism. Isn’t it great? And that guy is a teacher in an university… that’s really scary. After having re-invented the statistics, Séralini re-invented toxicology study!

  32. Merci, GFP, for a non-American (US) viewpoint on the topic. “We” here don’t typically get exposed to “foreign” media, and it is good to be reminded there are other opinions out there.

  33. Dr. Dan, I do thank you for listing this study for discussion. This is most definitely what I have been hoping for–an open debate/discussion from all sides. My own position is anti-gmo based on what I know (and don’t), the magnitude of what is at stake/risk, and all of the contradictory studies out there. I find it impossible to believe that all of the studies showing problems with gmo’s are politically motivated or any more poorly done than those showing no risk. When I apply the Precautionary Principle, as I understand it and believe in it as a guiding principle, the position seems clear. We can survive without this technology until we better understand it and can make a more responsible decision. We have other safe, proven options. I am not confident we have the knowledge to comprehensively understand all of the consequences of what we are doing. I also doubt financial and political motives and corporate/governmental/human will to always do the “right thing”–even when the effects are catastrophic. As a student of history who has lived 45 years, I have seen a lot of unbelievably bad policies, practices, and inventions.

    But all of that aside, I still would like to see a scientific debate on the merits and shortcomings of these studies to get a better understanding. I realize I could be wrong. I want to understand more.

    As far as the comparison of baby shampoo to Roundup, I’m not sure that the skin irritation is the central issue, although I do not know what that level of irritation is. Because we would not feel the Roundup, is it safe? Many examples of things not felt that are injurious come to mind. What about the cell toxicity and endocrine disrupting effects at the recommended concentrations of baby shampoo vs Roundup?

    I do not have the expertise to speak to the validity of Seralini’s methodology. I wrote to him and received this response which he said I could quote:

    “We work on the major environmental pollutants in mixtures or in formulations on the human cells from placenta or umbilical cord (cell lines or fresh cells), because we want to know if the Roundup formulation is toxic on babies or pregnant mothers. The other questions or remarks appear secondary to us, including what component is the most toxic in Roundup formulations. The formulation appears the most toxic anyway. If anybody has informations saying that baby shampoos are toxic at the levels we use Roundup formulations on our cells (dilutions up to 5.000.000), he should write immediately to authorities today, stopping other activities. Prof. Gilles-Eric Seralini.”

    I read GFP’s critique. I have read others that say the methodology is standard and sound. Does anyone have proof? Shouldn’t this at least be followed up on since we are eating roundup in ever larger quantities due to repeated spraying of RR corn, soy, and now sugar? These 3 items are in most of our foods. The diets of African aid recipients can be from 60-nearly 100% corn. Wheat could well be next for all of us, as you know. We, who are pregnant eat it, babies have it in their formulae and will continue to eat it over a lifetime. Then they will have children, etc. A multigenerational study such as Irina Ermakova’s would be a useful model to integrate feeding and endocrine disruption in vivo, if that is what we need. The 13 week study Ewan provided, although what I asked for, does not seem relevant to the endocrine issue–although it would provide the basis for a good discussion of its results and methodology, I am sure.

  34. Concerning séralini, I have just noticed today that he still insist in his mistake about the MON863. He claims he was using “appropriate statistical methodology”…
    http://www.biolsci.org/v05p0438.htm
    He cite Doull et al but forget to mention his “re-analysis” was properly repudiated by Afssa, EFSA and FSANZ.

  35. John Q Says:

    July 8, 2009 at 8:22 am
    Merci, GFP, for a non-American (US) viewpoint on the topic. “We” here don’t typically get exposed to “foreign” media, and it is good to be reminded there are other opinions out there.

    +++++++++++++++++
    John, you can access almost any foreign media online these days.

  36. Dr. Dan says:
    Finally, while I am not a lawyer, I am a forensic toxicologist. Daubert won’t help you much here. It does not determine truth- only admissability in a court of law. Some of the criteria utilized (essentially the Hill criteria) are certainly applicable to scientific assessment- but the purpose of Daubert lies in a very different realm.

    _________________________

    Sometimes the two overlap in Democracy. Not often enough, but sometimes:

    http://www.ca9.uscourts.gov/datastore/opinions/2009/06/24/07-16458.pdf

    http://www.ucsusa.org/food_and_agriculture/feed/feed-latest.html#3
    Monsanto loses again: GE alfalfa banned nationwide
    A federal court has upheld a ban on the planting of Monsanto’s genetically engineered (GE) alfalfa in the United States. The Court of Appeals for the Ninth Circuit reaffirmed its previous ruling that the alfalfa, which is engineered to tolerate the herbicide Roundup, could contaminate conventional and organic alfalfa and thus cause “irreversible harm” to the farmers whose livelihoods depend on these crops and to the environment. In the original lawsuit, the Center for Food Safety, other nonprofit organizations, and two alfalfa seed producers sued the U.S. Department of Agriculture (USDA) for approving GE alfalfa without preparing an environmental impact statement (EIS) as required by federal law. After the district court issued its original ruling in 2008 to ban the alfalfa, Monsanto and another biotechnology company appealed the ban, but their appeal was denied in this final ruling. The ban will remain in place until the USDA completes the EIS. Read more from Reuters, or read the decision (pdf).

    “We hope the USDA finally gets the message that it must fully evaluate the public health, environmental, and economic risks of GE crops before allowing them to be widely planted.” ~ Jane Rissler, Deputy Director/Senior Scientist

  37. Deborah said:

    “John, you can access almost any foreign media online these days.”

    Yes, we CAN, but very few US residents DO. I will leave it as an exercise for the interested reader as to why this is the case.

  38. Deborah,
    I dealt with many peoples like you on french forums and blogs about gmo (even on MM Robin’s blog). All anti-GM people present the same features, that’s a human behaviour. You want to trust Séralini simply because he tells you what you want to hear. And in spite of all rationnal arguments you can obtain from other people you will never change your mind. I provided you with a report of our french safety agency, composed of highly qualified toxicologists and a paper from The University of Kitakyushu about soap toxicity on unicellular alguae but you will continue to listen to some kind of activists like Séralini because you share the same “beliefs”, it is as simple as that. Without people like you Séralini and co would not exist. He needs to exploit the credulity and fears of people for his business. In the scientific community, he’s quite alone. Each time I deal with people like you, afterwards I feel really sad and frustrated because I have always hope that people with open mind exist but in fact there are very rare.

  39. Deborah,

    You raised the “Precautionary Principle,” so permit me to comment. I believe this to be a red herring, and misused by those opposed to new technologies as if it were a principle by which we live all other parts of our lives. Balderdash! If you really believe in the PP,you would never get out of bed in the morning.

    There are levels of risk associated with all human activity. This does mean that we stop in our tracks and do nothing. In many of our everyday, mundane tasks, there is risk (slipping in the shower, crossing the street, driving the car, etc.). However, if we applied the PP as you say, we would never do anything.

    But all of a sudden, the PP becomes a guiding light when the subject is genetic modification?

    Such thought is not rational.

  40. GFP Says:

    July 9, 2009 at 12:57 pm
    Concerning séralini, I have just noticed today that he still insist in his mistake about the MON863. He claims he was using “appropriate statistical methodology”…
    http://www.biolsci.org/v05p0438.htm
    He cite Doull et al but forget to mention his “re-analysis” was properly repudiated by Afssa, EFSA and FSANZ.

    ————————-
    GFP, can you please show us where and why Seralini’s reanalyis is “properly repudiated?”

  41. Dr. Dan, from your criticism of Seralini’s study above: “Seralini’s choice of cells was not biological but, I believe, political. Reproductive tissue cells were chosen, I submit, so that the author could scream, “endocrine disruptor.” ”

    In a comment by you posted in 2005, you and Donna R. Farmer remark:
    http://www.biotechknowledge.com/BIOTECH/knowcenter.nsf/ID/D373597C16175DED86256FBD005A5735?OpenDocument
    “The cells used in this study were taken from a human placental tumor, put into a Petri dish, and covered with culture media containing Roundup or other test materials. This direct exposure to high concentrations is vastly different than what would occur in a human or animal body, i.e. – the concentration of Roundup reported to have caused a reduction in aromatase activity was orders of magnitude greater than would result from the highest possible human exposure under real conditions. The direct exposure used in this study intentionally bypasses normal processes limiting absorption and cellular exposure and avoids normal metabolism, digestion and excretion that would protect cells from the minute amounts of chemical. These cell lines are used as mechanistic research tools and are not recognized or accepted by any regulatory agency or other scientific body in the world for the assessment of human health risks.”
    ************************************************
    At first, I thought you were criticizing his choice of cell lines as inappropriate for the study. So I looked up different methods and found many studies that use the JEG3 cell line. As a science-lay person, I ask you to explain your disagreement with this scientific protocol? For pesticide screening, isn’t it advisable and standard to check aromatase effects in vitro? To see if regulatory agencies recognize usage of JEG3, I searched EPA files for toxicological methods and found this Endocrine Disruptor Screening Program.

    How does Seralini’s use of the JEG3 cell line differ from the methods described here in EPA policy?:

    http://epa.gov/endo/pubs/edmvs/aromatase_drp_final_3_30_05.pdf

    “FINAL DETAILED REVIEW PAPER
    ON AROMATASE
    EPA CONTRACT NUMBER 68-W-01-023
    WORK ASSIGNMENTS 2-7 AND 5-5, TASK 2
    March 2005
    PREPARED FOR
    GARY E. TIMM
    WORK ASSIGNMENT MANAGER
    U.S. ENVIRONMENTAL PROTECTION AGENCY
    ENDOCRINE DISRUPTOR SCREENING PROGRAM
    WASHINGTON, D.C.
    PREPARED BY
    BATTELLE
    505 KING AVENUE
    COLUMBUS, OH 43201

    2.0 INTRODUCTION
    2.1 DEVELOPING AND IMPLEMENTING THE ENDOCRINE DISRUPTOR SCREENING PROGRAM (EDSP)

    In 1996, the passage of the two laws, the Food Quality Protection Act (FQPA) and
    Amendments to the Safe Drinking Water Act (SDWA) mandated the United States
    Environmental Protection Agency (U.S. EPA) to screen pesticides and authorized the EPA to screen chemicals found in drinking water to determine whether they possess estrogenic or other endocrine activity (Federal Register, 2001). The U. S. EPA is required to “develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effect…” (Federal Register, 2001). The U.S. EPA established the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), to provide recommendations regarding a strategy for developing a testing paradigm for compounds that may have activities similar to naturally-occurring hormones. Following the recommendations made by EDSTAC in its final report (EDSTAC, 1998), the EPA established the Endocrine Disruptor Screening Program (EDSP). The program’s
    aim is to develop a two-tiered approach, e.g., a combination of in vitro and in vivo mammalian and ecotoxicological screens (Tier 1) and a set of in vivo tests (Tier 2) for identifying and characterizing endocrine effects of pesticides, industrial chemicals, and environmental contaminants. This Detailed Review Paper was prepared for the U.S. EPA in 2002 to review the scientific basis of the aromatase assay and examine assays reported in the literature used to measure the effect of chemical substances on aromatase.
    An in vitro aromatase assay could easily be utilized as an alternative screening method in
    the Tier 1 Screening Battery to assess the potential effects of various environmental toxicants on aromatase activity. Both in vitro subcellular (microsomal) assays and cell-based assays are available for measuring aromatase activity. The in vitro subcellular assay using human placental microsomes, is commonly used to evaluate the ability of pharmaceuticals and environmental chemicals to inhibit aromatase activity. In addition, human JEG-3 and JAR choriocarcinoma cell culture lines, originally isolated from cytotrophoblasts of malignant placental tissues, have been used as in vitro systems for measuring the effects of compounds on aromatase activity. These cell lines are also utilized for investigations on the effects of agents in placental toxicology.
    Various organochlorine contaminants have been examined in the JEG-3 and/or JAR cell
    line systems. The contaminants 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and 3,3′,4,4′,5-pentachlorobiphenyl (PCB126) caused concentration-dependent decreases in the aromatase activity of up to 4.9-fold in the JEG-3 cells.104 The IC50 values for aromatase inhibition were 52 pM and 13 nM for TCDD, and 75 nM and 48 nM for PCB126 in the presence and absence of serum, respectively. These studies were further extended to twenty-one organochlorine PCB derivatives tested in both JEG-3 and JAR cell lines.105 Aromatase inhibition was observed, but cytotoxicity was also significant. These observations led to the conclusion by the authors that the JEG-3 and JAR cells “appear too sensitive” to the cytotoxic effects of organochlorines for use in evaluating effects on aromatase activity. The fungicide fenarimol was also evaluated in JEG-3 cells,95 exhibiting an IC50 value for aromatase inhibition of 2.0 μM. In general, the results on aromatase inhibition for a wide variety of chemical compounds that have been obtained from an intact cell system such as the JEG-3 or JAR cell culture lines are similar to the results from the human placental microsomal system.
    Test Method Performance and Test Method Reliability.

    An active test compound is evaluated in a full dose-response study (1.0 nM to 1.0 mM) with quadruplicate samples at each dose concentration tested. The full dose-response studies will be analyzed by nonlinear regression analysis, and dose-response curves will be generated. The IC50 values are determined from dose-response studies, and the log IC50 values, standard error of the log IC50 values, and the correlation coefficient will also be obtained in this analysis. This assay endpoint, i.e., measurement of aromatase activity, is accurate and reproducible.

    The JEG-3 cell culture assay is a common in vitro assays used for measuring aromatase and aromatase inhibition.25-38 The assay has been utilized extensively and performed reproducibly since the late 1980′s. It continues to be used in academic labs and pharmaceutical firms for aromatase inhibition and for investigations on the effects of agents in placental toxicology. The endpoint of the measurement of aromatase activity by the radiometric assay (3H2O method) is accurate as the assay measurement and is in agreement with the product isolation method. The relative inhibitory activities of aromatase inhibitors in JEG-3 cell culture assay are similar to the activities observed in human placental microsomal assays. However, the actual IC50 values can vary from lab to lab due to variable experiment conditions, such as substrate concentrations, cell number, and culture conditions, employed in the particular laboratory.”

    ************************
    If the goal is to test for endocrine disruption, how is Seralini’s method not standard? Does the method Seralini used differ from the EPA Endocrine Disruptor Screening model? If so, how?

  42. Deborah – reading further through the EPA document it time and again makes perfectly clear that in vitro studies using JEG-3 cells or similar systems at best provide a useful alternative high throughput method to identify substances which may warrant further investigation in in vivo studies – with the caveat by the consulted scientists that in vitro results do not necessarily translate to in vivo effects.

    Therefore, even granting these studies merit, they are not granted enough merit to make health claims about roundup – this requires in vivo studies – in vivo studies which have all shown roundup and its various formulations to be relatively harmless (aswell as 30 years of general useage without evidence of adverse effects) (sure Dr. Dan can add a lot more than this…)

  43. Ewan, we are seeing more reproductive problems, from infertility to miscarriage and malformation. Of course, there are many toxins in our environment, so I am hoping the researchers will do the studies necessary to protect our health and that of our environment. Look how long it took to show PCBs, DDT, atrazine, etc, are harmful, persistent, bioaccumulating, poisoning our water, food, and children. It’s better for everyone to discover these issues before they are so widespread–ideally before they are marketed. Consider how much Roundup is used:

    http://www.epa.gov/espp/litstatus/effects/glyphosate-analysis.pdf

    C. Chemical Use: The following is based on the currently registered uses of glyphosate:
    ‘ Type of Agent: Non-selective herbicide
    ‘ Classification: General Use
    ‘ Summary of Sites:
    < Aquatic uses: agricultural drainage systems, irrigation systems, lakes/ponds, reservoirs, streams, rivers, channeled water.
    < Forestry: conifer release, forest plantings, forest trees.
    < Food: acerola, apricot, artichoke, asparagus, atemoya, avocado, banana, beech nuts, blackberry, boysenberry, brazil nut, breadfruit, broccoli, brussels sprouts, butternut, cabbage, carambola, carrot, cashew, cauliflower, celery, chard, cherimoya, cherry, chestnut, chicory, cocoa, coffee, collards, cranberry, cress, cucumber, currant, date, dewberry, eggfruit tree, eggplant, elderberry, endive,fig, filbert, garlic, gooseberry, gourds, ground cherry, guava,
    hickory nut, horseradish, huckleberry, jaboticaba, jackfruit, kale,
    kitembilla, kiwi fruit, kohlrabi, leek, lettuce, litchi nut, loganberry,
    logan, loquat, macadamia nut, mamey, mango, marmalade box,
    mayhaw, melons, mustard, nectarine, okra, olive, onion, papaya,
    parsley, passion fruit, peach, pear, pecan, pepper, persimmon,
    pistachio, plantain, plum, pomegranate, prune, pumpkin, quince,
    radish, raspberry, rhubarb, rutabaga, sapodilla, sapota, soursop,
    spinach, squash, sugar apple, sweet potato, tamarind, taro, tea,
    walnut, yam.
    <
    Feed Crops: alfalfa, barley, beans, buckwheat, corn,
    grass/fodder/hay, lentils, millet, nongrass/forage/fodder/straw/hay,
    oats, pastures, rye, sorghum, wheat.
    <
    Food + Feed Crops: almond, anole, barley, beans, beets,
    buckwheat, calamodin, citron, citrus hybrids other than tangelo,
    corn, cotton, grapefruit, grapes, kumquat, lemon, lentils, lime,
    millet proso, mustard, orange, parsnip, peanuts, peas, pineapple,
    potato, pummelo, rape, rice, wild rice, rye, sorghum, soybeans,
    sugar beet, sugarcane, tangelo, tangerines, tomato, tritricale, turnip,
    wheat.
    <
    Other Non-Food/Feed Use: agricultural fallow/idleland, rights-of-
    way/fences/hedgerows, agricultural uncultivated areas,
    airports/landing fields, Christmas tree plantations, golf course turf,
    industrial sites (outdoor), nonagricultural outdoor buildings and
    structures, ornamental and/or shade trees, ornamental lawns and
    turf, ornamental woody shrubs and vines, paths/patios, paved
    areas, recreational sites, urban areas.
    <
    Residential: ornamental and/or shade trees, ornamental herbaceous
    plants, ornamental lawns and turf, ornamental shrubs and vines.
    ==================
    Drinking water info from US Geological Service:

    http://pubs.usgs.gov/sir/2008/5027/section6.html

    The two most commonly detected pesticides were the triazine herbicides simazine and atrazine, which occurred in about one-half of samples. Deethylatrazine (a degradate of atrazine) commonly was detected along with atrazine in about 30 percent of samples. The active ingredients in the common household herbicides RoundUP™ (glyphosate) and Crossbow™ (triclopyr and 2,4-D) also were frequently detected together. These three herbicides often made up most of the total pesticide concentration in tributaries throughout the study area.

    http://toxics.usgs.gov/highlights/glyphosate_wastewater.html

    Glyphosate Found in Wastewater Discharged to Streams

    Glyphosate is the most widely used herbicide in the world, and is widely used to control weeds in both agricultural fields and in urban and suburban settings. In 2002, USGS scientists sampled the wastewater discharged into streams from 10 wastewater treatment plants. Although the observed concentrations were small, these results are the first to demonstrate that the discharge from wastewater treatment plants serving urban areas is a source of glyphosate to streams. Samples were collected from the treated wastewater and from the stream water—both upstream and downstream of the wastewater discharge. Glyphosate was more frequently detected in the wastewater (27%) and in the downstream samples (20%) than it was in the upstream samples (12%). No detections were observed in two reference streams located in areas with little human influence. The discharge of the streams and the wastewater outfalls in this study were generally lower when compared to the discharge of the streams in a study of the occurrence of glyphosate in streams draining agricultural areas, so further research is needed to determine the relative loads (mass) of glyphosate from various sources.
    As with many studies on the occurrence of herbicides in streams, the degradates of the herbicide were more common than the parent compound. In this study of glyphosate, AMPA (aminomethyl phosphonic acid), a degradate of glyphosate, was found in higher concentrations and more frequently (68%) in wastewater than was glyphosate (18%). The results of this study can be used to assist water-resource managers make informed decisions regarding the environmental fate and effects of herbicides (and their degradates) that are applied in different land-use settings.

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    I want to know if it is harmful. It seems to have some known risks according to:
    VERMONT ELECTRIC POWER COMPANY’S
    NORTHWEST RELIABILITY PROJECT,
    WEED MANAGEMENT HERBICIDES
    AND
    ALTERNATIVES
    A REPORT
    FOR
    PUBLIC SERVICE BOARD
    DOCKET #6860

    In one study, glyphosate and AMPA were both still detectable in leaf litter 100 days after an application. A study in Finland found glyphosate and AMPA in reindeer lichens 270 days after application (Mensink, H. & P.Janssen, 1994).
    Concerns for plant communities on land: Because of its behavior in soil and ability to drift, glyphosate use holds dangers for plant communities. Researchers have found that glyphosate can drift as much as 130 feet and do harm to sensitive native species (Marrs, R.H. et al, 1993). Glyphosate can do damage to non-target plant species because it moves easily within the plant, damaging even unexposed parts of the plant. “Drift of herbicide can affect natural vegetation by damaging sensitive species and thereby altering the structure of the community in the long term.” Of four herbicides studied, wild plants were at a much greater risk of damage from glyphosate drift, in amounts as low as .1 micrograms per plant (Breeze, V. et al, 1992). Endangered plant species and viability of plant communities could be jeopardized because glyphosate can prevent calcium uptake by plant roots, increase plants’ susceptibility to pathogens, and inhibit growth of various soil micro-organisms (Carlisle, S.M. and J.T.Trevors, 1988). Glyphosate treatment made plants more susceptible to colonization of plant roots by pathogens because of complex plant /chemical interactions (Brammall, R.A. and V.J.Higgins, 1988).
    Several modes of glyphosate’s behavior raise concerns for maintaining the integrity of Charlotte’s sensitive plant communities, including wetlands.
    Concerns for aquatic ecosystems: Since glyphosate is the herbicide allowed for use close to water and is used in wetlands, the nontarget dangers of the herbicide in aquatic ecosystems need to be considered.

    Glyphosate is toxic to tadpoles and to frogs, although Roundup is more toxic than technical grade glyphosate because of the surfactant’s effects on the gills and skin of amphibians (Bidwell, J.R. and J.R.Gorrie, 1995).

    The adsorption of glyphosate to suspended clay particles in water can lengthen its persistence in the aquatic systems (Bowner, K.H., 1982) keeping it available to aquatic invertebrates that live in sediment and filter it through their bodies.

    *** Glyphosate can act as a nutrient in water because of its phosphate content, even amounts below detectable level, indirectly affecting fish habitat, and can cause mortality to larvae of an aquatic invertebrate species (Austin, A.P.,1991). [eutrophication, the Dead Zone comes back to mind]

    Concentrations of glyphosate below the detection limit may contain enough glyphosate to be available for adsorption to sediment (Newton, M.et al, 1984). Because glyphosate can drift off-target, bind to sediment and erode into streams, populations of invertebrates such as fresh-water mussels (some listed as Endangered or Threatened in Vermont) in affected streams could face additional risks to their survival.

    Concerns for animal life: Glyphosate is directly toxic to some beneficial insects, and can reduce the population of others through habitat reduction (Cox, C., 1998). Populations of voles and shrews were reduced for two to three years in Maine studies (Santillo, D.J., 1989. One researcher found that low chronic doses of glyphosate reduced the ability of rabbits to reproduce successfully because sperm were less viable, either because of the toxicity of glyphosate to cells or because reproductive hormones were disrupted (Yousef, M.I.et al, 1995).

    Concerns for humans: Humans are exposed from utility uses through occupational use of glyphosate, via drift or off-target from applications, through contact with contaminated soil, or drinking or bathing in contaminated water. In California where statistics on pesticide-related illness are recorded, glyphosate caused 28 reported systemic and respiratory acute illnesses, and 151 reported skin and eye acute illnesses between 1984 and 1990 (Pease, W.S. et al, 1993, p.8). Most injuries were associated with ground or hand application as well as with mixing and loading (Pease, W.S.et al, 1993, p.18). Other effects of glyphosate on human health include burning of eyes or skin, blurred vision, peeling of skin, nausea, headache, vomiting, numbness, burning of the genitals, and wheezing (California. EPA. DPR. 1993-95).

    New research indicates that glyphosate and its formulations cause DNA-damaging activity in the liver and kidney of mice. No significant difference is seen between the active ingredient and its formulation (Bolognesi, C.et al, 1997).
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    It looks to like Seralini et al concluded that more in vivo studies are warranted based on the in vitro tests. As a consumer and resident of this Finite Earth, I sure want to know and soon:

    http://pubs.acs.org/doi/full/10.1021/tx800218n?cookieSet=1
    All cell types, including primary cultures, react similarly at the membrane and mitochondrial level, justifying the hypothesis that the cell lines used provide excellent models to study human cell toxicity, for instance in placental cells (18). We show for the first time that embryonic and umbilical cells also have comparable sensitivity. The most reactive level reached appears to be the cell membrane level for the different formulations, but not for G. The supposed “inert ingredients” play obviously and differently the role of cell membrane disruptors, independently to G, as we have previously proposed (14), and this was suggested in fish, amphibians, and microorganisms (27, 45) or in plants (46)

    We now demonstrate that in human cells.The second level is the mitochondrial membrane and the enzymatic reaction in it, SD, localized in the internal membrane in complex II of the respiratory chain (47). It is altered in a comparable way, not proportional to G but relatively to the nature and the quantity of the adjuvants that we have previously listed (15). This means that the toxicity of G clearly varies with formulations that must imperatively now be used in in vivo tests to study any toxicity (45); this also means that the ADI of G must take into account its formulation, since 7.2 or 360 g/L of G may have comparable effects, considerably different to 400 g/L. It would even be more correct to use precisely an ADI of R instead of G. It may also be time-dependent. These ideas are not taken into account yet for regulatory legislation.The necessity to study combined effects also appears from our results. In fact, the body is always exposed to mixtures and not to single compounds. We have previously demonstrated that mixtures could amplify toxicity for other widely spread pollutants (2). For embryonic or neonatal cells, POEA, the major adjuvant, has the highest toxicity, either by itself or amplified 2−5 times in combination with G or AMPA. It has already been shown that POEA is highly toxic for sea urchin embryos, impinging on transcription (28). It is also known that in an aquatic environment, POEA has higher effects than R and G on bacteria, microalgae, protozoa, and crustaceans (12). In addition, the known metabolism of G in the soil or plants is supposed to detoxify it in AMPA (11); however, here, we demonstrate that AMPA is more toxic than G in human cells, especially on cell membrane. AMPA is also more stable in soil (48), in plants, and in food or feed residues (49), and more present in wastewater (2−35 ppm) than G [0.1−3 ppm; (50)]. It is not toxic alone at these concentrations in our experiments, but it amplifies G or POEA toxicity in combination. The synergic toxicity of all of these compounds is now more obvious.

  44. The us geographical info I cited above regards wastewater in tributaries downstream of wastewater treatment plants, not drinking water. My mistake. I thought I had something on Farm Belt wells, but will have to keep searching.

    Look what EPA says about Roundup/Glyphosate:

    http://www.epa.gov/safewater/contaminants/dw_contamfs/glyphosa.html

    What are the Health Effects?
    Short-term: EPA has found glyphosate to potentially cause the following health effects when people are exposed to it at levels above the MCL for relatively short periods of time: congestion of the lungs; increased breathing rate.

    Long-term: Glyphosate has the potential to cause the following effects from a lifetime exposure at levels above the MCL: kidney damage, ++++reproductive effects+++++.