8. The choice of experimental animals
BVL says in its response to Carrasco that while developmental mechanisms in frogs and chicken embryos are similar to those of humans, they respond differently to toxins because frogs and chickens lack the protection of a placental barrier – their embryos develop outside the mother’s body. BVL says humans and other mammals, in contrast, have a placental barrier that lends some protection against toxins passing from the mother’s blood supply to that of the foetus. Therefore, BVL says, findings in frog and chicken embryos cannot be extrapolated to humans and doses of glyphosate reaching the human foetus are unknown.
However, BVL fails to acknowledge research showing that a significant percentage of glyphosate crosses the human placental barrier and enters the foetal compartment.222 BVL must produce data to back up its implication that the human placental barrier provides protection against glyphosate exposures.
In addition, Dallegrave’s 2003 study found skeletal malformations in rats treated with Roundup.223 Rats are mammals, so BVL cannot dismiss this study on grounds of the wrong choice of experimental animal. But BVL finds another reason to dismiss Dallegrave’s study, wrongly claiming that it found no craniofacial malformations (see Section 5, above).
Roundup and birth defects: Is the public being kept in the d
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Re: Roundup and birth defects: Is the public being kept in t
by admin » Sun Jan 10, 2016 9:15 am
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Re: Roundup and birth defects: Is the public being kept in t
by admin » Sun Jan 10, 2016 9:16 am
9. South America’s responsibility?
BVL implies that the problems with glyphosate raised by Carrasco’s research are South America’s responsibility. It says, “Even if there were indications for an increase in malformations because of extensive exposure to pesticides in South America, the state authorities in these countries would be responsible to initiate more in-depth investigations. Taking into account the very different application conditions and the uncertainties with regard to the plant protection products and human exposure, such findings would not automatically give rise to concern about the safety of glyphosate-based herbicides in Europe.”
It is true that application conditions and exposures in Europe would be different from those in South America. But BVL and the Commission have made no attempt to define how they would differ, especially in the light of the possible cultivation of glyphosate-tolerant crops in the EU. BVL’s statement is inadequate, for the following reasons.
Toxicological findings are not confined within national boundaries
In its discussion of possible effects of Roundup/glyphosate on humans, BVL avoids mentioning the toxicological findings on Roundup and glyphosate. Some of these, such as those of Séralini’s team, found effects in human cells and are relevant to humans. While BVL disingenuously confines its discussion of effects on humans to South America, toxicological findings in human cells, and findings in mammals such as in Dallegrave’s studies, apply to all countries where Roundup/glyphosate is used.
Also, glyphosate-tolerant crops carrying glyphosate residues enter the European food chain via animal feed and soy products eaten by humans. The Commission must investigate current and potential future exposures and their relationship to findings in the independent scientific literature.
The political climate in South America is problematic
Some South American economies have become highly dependent on the GM soy/glyphosate agricultural model, so central and regional government authorities are reluctant to challenge it. The Argentine government has come to rely on export taxes on soybeans, which reached 35 per cent in 2010.224
In Argentina, after Carrasco announced his findings, a group of environmental lawyers launched a lawsuit petitioning the government to ban glyphosate. But Guillermo Cal, executive director of CASAFE (Argentina’s crop protection trade association), said a ban would mean “we couldn’t do agriculture in Argentina”.225
Argentine scientists and experts who have produced evidence of problems with the GM soy/glyphosate model report harassment and censorship.226 227 228 But even in these difficult conditions, they and their international colleagues have collectively produced more than enough evidence to indicate that there are serious problems with the GM soy/glyphosate agricultural model.
Europe has a moral responsibility to its supplier countries
As much of the glyphosate-tolerant soy sprayed with glyphosate herbicides in South America is imported to feed European livestock, Europe is to some extent responsible for the situation in South America. The principle of moral responsibility for human rights abuses in supplier countries has been accepted since eighteenth-century debates about the slave trade.
Europe is considering adopting the GM crops/glyphosate farming model
Applications are in the approvals pipeline for the cultivation in Europe of several glyphosate-tolerant GM maize varieties, including Monsanto’s NK603230 and MON89034 x MON88017.231 If glyphosate-tolerant crops are approved for cultivation in the EU, then the South American experience with GM soy and glyphosate could be replicated in Europe. BVL’s attempt to draw a curtain over the South American experience is irresponsible because it ignores the potential impact of this carcinogen and teratogen on European farmers, their families, and the public.
BVL implies that the problems with glyphosate raised by Carrasco’s research are South America’s responsibility. It says, “Even if there were indications for an increase in malformations because of extensive exposure to pesticides in South America, the state authorities in these countries would be responsible to initiate more in-depth investigations. Taking into account the very different application conditions and the uncertainties with regard to the plant protection products and human exposure, such findings would not automatically give rise to concern about the safety of glyphosate-based herbicides in Europe.”
It is true that application conditions and exposures in Europe would be different from those in South America. But BVL and the Commission have made no attempt to define how they would differ, especially in the light of the possible cultivation of glyphosate-tolerant crops in the EU. BVL’s statement is inadequate, for the following reasons.
Toxicological findings are not confined within national boundaries
In its discussion of possible effects of Roundup/glyphosate on humans, BVL avoids mentioning the toxicological findings on Roundup and glyphosate. Some of these, such as those of Séralini’s team, found effects in human cells and are relevant to humans. While BVL disingenuously confines its discussion of effects on humans to South America, toxicological findings in human cells, and findings in mammals such as in Dallegrave’s studies, apply to all countries where Roundup/glyphosate is used.
Also, glyphosate-tolerant crops carrying glyphosate residues enter the European food chain via animal feed and soy products eaten by humans. The Commission must investigate current and potential future exposures and their relationship to findings in the independent scientific literature.
The political climate in South America is problematic
Some South American economies have become highly dependent on the GM soy/glyphosate agricultural model, so central and regional government authorities are reluctant to challenge it. The Argentine government has come to rely on export taxes on soybeans, which reached 35 per cent in 2010.224
In Argentina, after Carrasco announced his findings, a group of environmental lawyers launched a lawsuit petitioning the government to ban glyphosate. But Guillermo Cal, executive director of CASAFE (Argentina’s crop protection trade association), said a ban would mean “we couldn’t do agriculture in Argentina”.225
Argentine scientists and experts who have produced evidence of problems with the GM soy/glyphosate model report harassment and censorship.226 227 228 But even in these difficult conditions, they and their international colleagues have collectively produced more than enough evidence to indicate that there are serious problems with the GM soy/glyphosate agricultural model.
POEA: Case study in regulatory weakness
BVL’s only decisive recommendation in its response to Carrasco is that more toxicity tests should be conducted on the effects on aquatic organisms of the Roundup adjuvant or added ingredient, POEA (polyethoxylated tallow amine). POEA is added to glyphosate herbicides as a surfactant or wetting agent, to enable the glyphosate to penetrate the plant. Unfortunately, POEA is highly toxic to human cells as well as increasing the toxicity of glyphosate by allowing it to penetrate the cells more easily.232
While action on POEA would be welcome, focusing only on this substance distracts from Carrasco’s finding that pure glyphosate is a developmental and reproductive toxin.233
The case of POEA shows the weakness of EU regulators in dealing with industry. The German government recommended as long ago as 1999 that POEA should be phased out in the EU. Monsanto disagreed.234 Eleven years later in 2010, the German government was still asking for action on POEA – and still being ignored by industry and EU regulators.235 It has resorted to taking its own measures to restrict the use of POEA within Germany.
Europe has a moral responsibility to its supplier countries
As much of the glyphosate-tolerant soy sprayed with glyphosate herbicides in South America is imported to feed European livestock, Europe is to some extent responsible for the situation in South America. The principle of moral responsibility for human rights abuses in supplier countries has been accepted since eighteenth-century debates about the slave trade.
Europe is considering adopting the GM crops/glyphosate farming model
Applications are in the approvals pipeline for the cultivation in Europe of several glyphosate-tolerant GM maize varieties, including Monsanto’s NK603230 and MON89034 x MON88017.231 If glyphosate-tolerant crops are approved for cultivation in the EU, then the South American experience with GM soy and glyphosate could be replicated in Europe. BVL’s attempt to draw a curtain over the South American experience is irresponsible because it ignores the potential impact of this carcinogen and teratogen on European farmers, their families, and the public.
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Re: Roundup and birth defects: Is the public being kept in t
by admin » Sun Jan 10, 2016 9:16 am
10. Science divided
Carrasco notes in his reply to Monsanto/Dow that discussion of toxics risk assessment has separated into two diverging strands:
It is to be expected that industry should look after its own interests. But it is inexcusable for the public body BVL to follow Monsanto/Dow in what seems to be a desperate attempt to dismiss any possibility of Roundup/glyphosate’s teratogenicity rather than ordering further investigations to clear up uncertainties. However, the existing body of evidence on Roundup/glyphosate is more than sufficient to justify that BVL advise the EU Commission to invoke the precautionary principle and conduct an immediate review of the herbicide.
Carrasco notes in his reply to Monsanto/Dow that discussion of toxics risk assessment has separated into two diverging strands:
Rather than pointing out shortcomings of our research, the [Monsanto/Dow] letter illustrates the increasing difficulty in dialogues between those with a vested interest in product sales and independent researchers who wish simply to understand whether the said products are safe.236
It is to be expected that industry should look after its own interests. But it is inexcusable for the public body BVL to follow Monsanto/Dow in what seems to be a desperate attempt to dismiss any possibility of Roundup/glyphosate’s teratogenicity rather than ordering further investigations to clear up uncertainties. However, the existing body of evidence on Roundup/glyphosate is more than sufficient to justify that BVL advise the EU Commission to invoke the precautionary principle and conduct an immediate review of the herbicide.
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Re: Roundup and birth defects: Is the public being kept in t
by admin » Sun Jan 10, 2016 9:17 am
11. Another worrying study on Roundup dismissed
BVL’s response to Carrasco’s study was not a one-off. In 2009, BVL issued a similarly dismissive response237 to a study by Benachour and Séralini, which found that Roundup caused total cell death in human umbilical, embryonic, and placental cells within 24 hours.238 In these experiments, Roundup obtained from the market was diluted by 100,000 times – far below the concentrations used when the chemical is sprayed on GM RR crops.
The researchers tested Roundup formulations, as well as pure glyphosate, AMPA (glyphosate’s main breakdown product), and the adjuvant POEA. They concluded that the presence of adjuvants increases the permeability of human cells to Roundup and amplifies the toxicity of glyphosate:
BVL’s response to this complex and worrying study was as brief as it was inadequate. Passing over the findings on the toxicity of glyphosate and AMPA, BVL only admitted that POEA (“tallow amines”) was a problem. It said it had asked manufacturers of glyphosate herbicides to replace tallow amines with less problematic ingredients within two years. That was the sum of BVL’s recommendations.
In choosing to focus solely on the adjuvant POEA, BVL simply ignored all the harmful effects that the researchers found with the Roundup formulations as a whole, their active ingredient glyphosate, and glyphosate’s main breakdown product, AMPA. So Roundup continues to be marketed without restriction and people continue to be put at risk.
BVL’s response to Carrasco’s study was not a one-off. In 2009, BVL issued a similarly dismissive response237 to a study by Benachour and Séralini, which found that Roundup caused total cell death in human umbilical, embryonic, and placental cells within 24 hours.238 In these experiments, Roundup obtained from the market was diluted by 100,000 times – far below the concentrations used when the chemical is sprayed on GM RR crops.
The researchers tested Roundup formulations, as well as pure glyphosate, AMPA (glyphosate’s main breakdown product), and the adjuvant POEA. They concluded that the presence of adjuvants increases the permeability of human cells to Roundup and amplifies the toxicity of glyphosate:
The proprietary mixtures available on the market could cause cell damage and even death around residual levels to be expected, especially in food and feed derived from R (Roundup) formulation-treated crops.239
BVL’s response to this complex and worrying study was as brief as it was inadequate. Passing over the findings on the toxicity of glyphosate and AMPA, BVL only admitted that POEA (“tallow amines”) was a problem. It said it had asked manufacturers of glyphosate herbicides to replace tallow amines with less problematic ingredients within two years. That was the sum of BVL’s recommendations.
In choosing to focus solely on the adjuvant POEA, BVL simply ignored all the harmful effects that the researchers found with the Roundup formulations as a whole, their active ingredient glyphosate, and glyphosate’s main breakdown product, AMPA. So Roundup continues to be marketed without restriction and people continue to be put at risk.
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Re: Roundup and birth defects: Is the public being kept in t
by admin » Sun Jan 10, 2016 9:20 am
12. What’s wrong with the current approval of glyphosate?
Glyphosate’s current approval in the EU is based on the 2002 review, carried out under the old pesticides regulation 91/414.240 The 2002 review assesses glyphosate, the glyphosate derivative herbicide glyphosate trimesium, and the glyphosate metabolite (breakdown product) AMPA.
The review exemplifies the general failings of the old pesticides approvals system:
●●Insulation from independent peer reviewed scientific findings
●●Old, outdated, and badly informed claims for glyphosate’s safety go unchallenged
●●Virtually exclusive reliance on industry studies for the safety assessment, with the inherent conflicts of interest
●●Reliance on studies with old and outdated protocols
●●Reliance on dubious and outdated assumptions
●●Lack of transparency
●●Failure to test the complete glyphosate formulations as they are sold.
A detailed breakdown of these factors follows.
12.1 Open peer reviewed scientific literature is denied
There is broad agreement in the scientific community that peer reviewed publication is the best currently available method to ensure reliable scientific data.
There are undoubted flaws with the peer review process – including publication bias, where certain types of results are more likely to be published than others,241 242 243 and pressure being placed on journal editors not to publish, or to retract, certain findings.244 245 246 Some journals have been generated or “captured” by industry and use industry-connected peer reviewers.247
In spite of these problems, the strength of the peer review process is that studies in the open literature can be evaluated by independent experts. Their findings can be confirmed, built upon, or contradicted by further studies.
The public, too, has been educated to respect the peer review process and to expect scientific claims to be validated in this way. The part-industry-funded UK-based group Sense About Science, which calls itself “an independent charitable trust promoting good science and evidence in public debates”248 and promotes the safety of controversial technologies like genetically modified foods,249 set up an entire project to convince the public that peer review is “an essential arbiter of scientific quality”.250 In its guide for the public on peer review, I Don’t Know What to Believe, Sense About Science says:
Given such influential messages, it would shock the public to realize that in the pesticide approvals process, peer reviewed open literature is not normally considered. The studies on which the 2002 EU review of glyphosate is based, as is the norm with pesticides, were generated and submitted by industry.252 The conclusions about the health hazards of glyphosate in the 2002 EU review are strikingly at variance with the findings from the independent scientific literature, as the analysis below shows.
Genotoxicity
The 2002 review flatly states that glyphosate and glyphosate trimesium are “not genotoxic” (causing damage to DNA). It is difficult to understand how this conclusion could be reached, given that even industry studies from the 1980s found that Roundup caused chromosome aberrations and gene mutations in mice lymphoid cells.253 254
In addition, a number of studies showing that glyphosate and Roundup are genotoxic existed in the peer reviewed literature even at the time of the 2002 review. Findings include:
●●Roundup increases the frequency of gender-linked lethal recessive mutations in fruit flies (these mutations are normally only seen in males).255
●●Roundup increases the frequency of DNA adducts (the binding to genetic material of reactive molecules that lead to mutations) in the liver and kidneys of mice at all three doses tested. The response was dose-dependent.256
●●Roundup causes increased frequency of sister chromatid exchanges in human lymphocytes (white blood cells), even at the lowest dose tested.257
●●Mice injected with glyphosate and Roundup show increased frequency of chromosome damage and increased DNA damage in bone marrow, liver, and kidney.258
Numerous additional recent studies confirm genotoxicity:
●●Roundup damages the DNA in the blood cells of European eels at environmentally relevant concentrations.259
●●Roundup has adverse effects on the cells of various organs in fish exposed at sublethal concentrations of 5–15 ppm (a typical concentration in a post-application site). Effects include hyperplasia (increased proliferation of cells) and increased activity of metabolic enzymes.260
●●Glyphosate-based herbicides cause increased frequency of DNA strand breaks and cell nucleus abnormalities indicative of mutagenic stress in goldfish at low doses (5–15 ppm).261
●●Glyphosate-based herbicides cause DNA damage and endocrine disruption in human cells at levels up to 800 times lower than glyphosate residue levels allowed in some GM crops used for animal feed in the United States.262
●●Glyphosate-based herbicides inhibit RNA transcription and delay hatching in sea urchin embryos at a concentration well below that recommended for commercial spray application. The Roundup surfactant polyoxyethylene amine (POEA) is highly toxic to the embryos when tested alone and so could contribute to the inhibition of hatching.263
●●Glyphosate-based herbicides and glyphosate’s main metabolite (environmental breakdown product), AMPA, alter cell cycle checkpoints in sea urchin embryos by interfering with the physiological DNA repair machinery. Such cell cycle dysfunction is seen from the first cell division in the sea urchin embryos.264 265 266 267 The failure of cell cycle checkpoints is known to lead to genomic instability and the possible development of cancer in humans. Studies on glyphosate and AMPA suggest that the irreversible damage that they cause to DNA may increase the risk of cancer.268 269
●●An epidemiological study in Ecuador found a higher degree of DNA damage in people living in an area that was aerially sprayed with glyphosate compared with those living 80 kilometres away.270
AMPA, glyphosate’s main breakdown product (metabolite), is also genotoxic in isolation. The 2002 review, on the basis of the industry studies, calls AMPA “less toxic than the parent compound”.271 The ECCO Panel states, “AMPA is not of toxicological significance.”272 However, an independent study found that AMPA is genotoxic, damaging DNA in human cells at very low doses and in mice at a dose of 200–400mg/kg.273
Carcinogenicity
The 2002 review claims “no evidence” of carcinogenicity for glyphosate and glyphosate trimesium. But glyphosate was known to have carcinogenic effects long before the 2002 review.
Two long-term studies on rats were conducted in 1979–1981 and 1988–1990.274 The rats received 3, 10 and 32 mg/kg of glyphosate per day in the first study and 100, 410 and 1060 mg/kg per day in the second. The first study found a significant increase in tumours in the testes of rats fed glyphosate, but the same effect was not found in the second test using the higher doses. On this basis, glyphosate was excluded from the carcinogenic category.275 276
This move was based on outdated and incorrect assumptions about toxicology. It used to be thought that toxic effects increased in proportion to dose, and that there is a safe level of a chemical, below which toxic effects are not found. But toxicologists now know that these assumptions are not always true. Some chemicals have more potent effects (notably endocrine effects) at low doses than higher doses.277 In some cases, no safe threshold can be found.278 279 However, regulators have not revised their conclusions on glyphosate based on up-to-date scientific knowledge.
Studies from the independent literature also show that Roundup and glyphosate have carcinogenic effects:
●●Glyphosate induces cancer in mouse skin280
●●Epidemiological studies show a link between Roundup/glyphosate exposure and two types of cancer: multiple myeloma281 and non-Hodgkin’s lymphoma.282 283 284
●●Other studies (mentioned under Genotoxicity, above) show that Roundup, glyphosate, and its metabolite AMPA cause changes to cells and DNA that are known to lead to cancer.285 286 287 288 289 290
Neurotoxicity
The 2002 review of glyphosate claims “no relevant effects” in tests for delayed neurotoxicity. But glyphosate is an organophosphate, a class of chemicals known to have neurotoxic effects, so claims of “no relevant” neurotoxic effects demand a strong and transparent evidence base to back them up.
In fact, studies from the open literature have found neurotoxic effects of glyphosate:
●●An epidemiological study carried out in Minnesota, USA found that the children of pesticide applicators exposed to glyphosate had an increased incidence of neurobehavioral disorders.291
●●In an acute poisoning incident, a man who accidentally sprayed himself with glyphosate developed the neurological disorder Parkinsonism.292
●●A toxicological study on rats found that glyphosate depletes the neurotransmitters serotonin (serotonin is associated with feelings of well-being and is known as the “happiness hormone”) and dopamine.293
●●Glyphosate causes a loss of mitochondrial transmembrane potential (a hallmark of cellular injuries) in rat brain cells.294
●●Glyphosate and Roundup act synergistically with the organophosphate insecticide diazinon in neuroblastoma (nerve cancer) cells. Glyphosate and Roundup become more neurotoxic when the cells have been pre-exposed to diazinon. Roundup is more toxic than glyphosate and produces effects at a concentration as low as 10 ppb, which is equivalent to a glyphosate concentration of 0.5 nM. Unusual dose-response relationships are found with both glyphosate and Roundup, which the authors say merit further investigation as they indicate that the relationship between concentration and toxicity at low concentrations may not be entirely predictable.295
Reproductive and developmental toxicity and endocrine disruption
The 2002 review notes that studies on glyphosate and glyphosate trimesium found reduced pup weight and decrease in litter size and pup body weight gain, but says these effects are confined to high, “parentally toxic doses”. The review adds that effects include lower number of viable foetuses and reduced foetal weight, retarded ossification (bone formation), and higher incidence of skeletal and/or visceral (internal organ) anomalies. Effects of glyphosate trimesium include increased post-implantation losses (miscarriage), reduced foetal weight, and increased incidence of rib “variations” at maternally toxic doses.
The 2002 review gives a developmental NOAEL (the highest level at which the effect being looked for is not found) of 300 mg/kg bw/d for glyphosate and 40 mg/kg bw/d for glyphosate trimesium. However, studies from the open literature have found adverse reproductive and developmental effects, in some cases at much lower levels. While we have discussed some of these studies in the above sections, we provide a comprehensive summary as follows:
●●Glyphosate herbicide alters hormone levels in female catfish and decreases egg viability. The study concludes that the presence of glyphosate in water is harmful to catfish reproduction.296
●●Roundup disrupts production of the steroid hormone progesterone in mouse cells by disrupting expression of a regulatory protein.297
●●Roundup causes decreased sperm numbers and increased abnormal sperms in rats.298
●●A commercial formulation of glyphosate was found to be a potent endocrine disruptor in rats, causing disturbances in their reproductive development after they were exposed during puberty.299
●●In human cells, glyphosate-based herbicides prevent the action of androgens, the masculinising hormones, at levels up to 800 times lower than glyphosate residue levels allowed in some GM crops used for animal feed in the United States. DNA damage is found in human cells treated with glyphosate-based herbicides at these levels. Glyphosate-based herbicides also disrupt the action and formation of estrogens, the feminizing hormones.300 This in vitro study found the first toxic effects of glyphosate-based herbicide at 5 ppm, and the first endocrine disrupting actions at 0.5 ppm – 800 times less than the 400 ppm level authorized by the US Environmental Protection Agency (EPA) in some animal feeds.301 302
●●Glyphosate acts synergistically with estrogen, disrupting estrogen-regulated gene expression in human cells.303
●●Glyphosate is toxic to human placental cells and this effect increases in the presence of Roundup adjuvants. Roundup acts as an endocrine disruptor, inhibiting an enzyme responsible for estrogen production. The authors conclude that Roundup could cause reproductive problems in humans at levels below those used in agriculture.304 The authors suggest that their results could explain epidemiological findings of increased premature births and miscarriages in female members of farming families using glyphosate.305 306
●●Glyphosate and Roundup damage human embryonic cells and placental cells, in concentrations well below those recommended for agricultural use. The study’s authors conclude that Roundup may interfere with human reproduction and embryonic development.307
●●The foetuses of rats fed orally with high doses of Roundup had increased incidence of skeletal malformations.308
●●Roundup causes malformations in frog and chicken embryos at doses much lower than those used in agricultural spraying.309 Malformations were of the craniofacial and neural tube type (of the skull, face, and developing brain and spinal cord).
Conclusion of open peer-reviewed literature on health effects
Both the existing pesticides regulation, 91/414, and the new regulation, 1107/2009, require that a pesticide should not have any harmful effect on human or animal health.310 311 The new regulation is stricter, since “vulnerable groups” must be considered in the human health assessment and known “cumulative and synergistic effects” of the pesticide must be addressed.312 Clearly, glyphosate herbicides do not even meet the requirements of the old regulation, so their approval should be reviewed immediately with a view to restricting or banning their use.
12.2. Outdated and badly informed claims go unchallenged
The discussion between industry, the rapporteur Germany, member states, and the ECCO Panel that led to the 2002 review includes numerous old, outdated, and badly informed claims for the safety of glyphosate and its breakdown product AMPA. Many of these claims have been superseded or discredited by independent studies – but they passed through the review process unchallenged and have remained in place in the regulatory system ever since. Similarly, concerns are raised but not followed up.
Anyone who is informed about the current state of knowledge on glyphosate cannot fail to be alarmed by these claims and uninvestigated concerns. There are too many to cover fully in this report, but a few examples follow.
Unresolved concerns about salivary gland lesions
Concerns about repeated findings of salivary gland lesions in experimental animals treated with glyphosate are expressed throughout the DAR materials and mentioned in the 2002 final review report. However, nobody seems to know what the lesions mean, and no attempt is made to find out. A comment by the ECCO Panel is typical:
The regulators should have insisted that these experiments be continued for a longer period, so that the true consequences of these lesions were revealed. Salivary gland lesions can be pre-cancerous.
Failure to consider endocrine disruption
The ECCO Panel says, “Various literature references suggest that glyphosate is an endocrine disruptor.” Again, the panel has no idea what to make of these findings: “The group recognised that there was no guidance available regarding how such information should be used so it was agreed that the rapporteur should consult the Chairperson of the mammalian toxicology meeting at the BBA [German Federal Ministry for Food, Agriculture and Consumer Protection] to see if this is a concern.”314 The final review report of 2002 does not mention endocrine disruption – sufficient reason in itself why the current approval of glyphosate is inadequate. However, independent studies show that glyphosate herbicides are endocrine disruptors.315 316 317
Failure to consider the impact of glyphosate-resistant weeds
The DAR and 2002 review report were compiled before the problem of glyphosate-resistant weeds became widespread. Monsanto claims in the DAR materials that it has tested over 500 samples and found that only two locations in Australia were affected. The plant involved was an annual rye grass.318 The UK Pesticides Safety Directorate (PSD) comments, “It is likely that resistance is low, although there have been two further reports of possible cases in America and Asia.”319 Since the EU Commission’s 2002 approval of glyphosate, a large number of independent studies and media reports have documented the extensive and serious problems caused by glyphosate-resistant superweeds, especially in North and South America. 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 Glyphosate’s current approval does not take this into consideration and a critical re-assessment is urgently needed.
In addition, the risk assessment should consider the inevitable shift in herbicide use after glyphosate-resistant weed populations become widespread. The published studies and articles cited above show that weeds evolve resistance to glyphosate within 2–6 years of cultivation of genetically modified (GM) Roundup Ready crops. This is less time than the approval period of a pesticide in the EU – formerly ten years, now 15 years. Once resistant weed populations are established, farmers have to resort to other potentially even more toxic herbicides, including 2,4-D, to try to control glyphosate-resistant weeds.335 336 337 338
The chemical companies Dow, DuPont, Bayer, BASF, and Syngenta have responded to the superweeds problem by “engineering crop varieties that will enable farmers to spray on the tough old weedkillers freely, instead of having to apply them surgically in order to spare crops”, according to a report in the Wall Street Journal.339 Bayer has patented a GM soybean with tolerance to the herbicide glufosinate ammonium.340 Studies show that glufosinate ammonium is a neurotoxin341 and causes birth defects in mice.342 Monsanto plans to release a dicamba-resistant GM soybean in 2013.343 These developments are relevant to Europe as Romania is lobbying the EU for permission to cultivate GM soy.344
A new generation of herbicide-resistant crops is being engineered with stacked traits to tolerate multiple herbicides.345 But weed scientists have commented that these new GM crops will only buy growers a little more time until weeds evolve resistance to other herbicides.346 In fact, weed species resistant to dicamba and 2,4-D already exist.347 348
The existing approval of glyphosate fails to take into consideration the chemical treadmill resulting from the emergence of glyphosate-resistant weeds – and the consequences to human health and the environment. While a full consideration of this issue is beyond the scope of this report, it needs to be addressed in the risk assessment of glyphosate as it is a hazard inherent in the use of the herbicide.
Incorrect claim about biological availability of glyphosate
The UK Pesticides Safety Directorate (PSD) notes that the issue of a waiting period between glyphosate spraying and re-entry into fields in order to protect humans, livestock, and plants, is not properly dealt with in Germany’s DAR. However, the PSD immediately dismisses this concern:
But this claim was not true even at the time of the DAR. A 1983 study showed that glyphosate persists in sandy loam soil and is not inactivated in the 120 days prior to planting. Plants growing in the glyphosate-treated soil showed decreased nitrogen fixation, root nodule numbers and root weights – indicating that glyphosate was biologically available and toxic to plants 120 days after application.350
A new risk assessment should address the issue of the re-entry period.
Incorrect claim about biological activity of AMPA
Monsanto says AMPA’s long persistence in soil is of no “regulatory concern” because “AMPA is biologically inactive”.351 But a 2004 study showed that AMPA causes injury to glyphosate-tolerant and non-glyphosate-tolerant soybeans. Findings are the same when the AMPA is deliberately applied and when it forms from the breakdown of applied glyphosate. The study concludes that soybean injury to glyphosate-tolerant soybeans from glyphosate is due to AMPA formed from glyphosate degradation.352 Therefore AMPA is biologically active.
It is clear that the documents on which the existing approval of glyphosate is based are out of date and out of touch with current scientific knowledge and farmer experience.
12.3. Industry tests have conflicts of interest
There are clear conflicts of interest in the 2002 review of glyphosate in that the companies that commissioned the tests and submitted the data also market the product. The fact that this is the norm in pesticides approvals does not make it acceptable. The main data submitters were Monsanto, Cheminova, Feinchemie, and Syngenta (formerly Zeneca).353 These companies manufacture and/or sell glyphosate herbicide. Monsanto, Syngenta, and Dow AgroScience (another data submitter) also sell GM glyphosate-tolerant seeds.
12.4. Industry tests are old and use outdated protocols
Anyone who is familiar with the rapid evolution of scientific knowledge relating to glyphosate over the past decade would be shocked to see that its current approval depends mostly on studies dating from the 1990s – some from as far back as the 1970s and 1980s.
In the 1990s glyphosate was still frequently claimed to be safe and environmentally friendly. Few independent studies were in existence to contradict these claims. Even so, by 1996, independent science had moved on to such an extent that a New York court ruled that Monsanto was no longer allowed to claim that Roundup was “safe, non-toxic, harmless or free from risk”, or as biodegradable.354 During the 2000s, a battery of independent scientific studies showed serious toxic effects from Roundup and glyphosate. None of this knowledge has made its way through to the regulatory system.
12.5. The approvals system is not transparent
In theory, the industry dossier of studies on a pesticide and the regulators’ discussions and justifications for their final decision are in the public domain. In practice, it is not so straightforward. The authors of this report had difficulty obtaining the materials. When they were finally obtained, a part of Germany’s DAR was withheld. The materials were confusingly presented and difficult to interpret. In the DAR itself, justifications for important decisions are not recorded in detail.
Data protection is claimed for many of the industry studies in the 2002 review of glyphosate on grounds of commercial confidentiality. This is standard practice, ostensibly because it prevents data from getting into the hands of competitor companies. Unfortunately, it also prevents the public and independent scientists from evaluating the data. So tests of unknown quality and unknown reliability are used to allow pesticides onto the market.
There is also no transparent system in place for considering independent scientific data that comes to light after the approval, as is clear from the case of Carrasco’s study.
12.6. The complete formulations as they are sold were not tested
The existing review of glyphosate fails to take into account the complete formulations as they are currently sold. Glyphosate herbicides contain adjuvants (added ingredients) which are themselves toxic and which can act synergistically with glyphosate to increase its toxicity. Studies show that Roundup is more toxic than glyphosate alone because the adjuvants enable the glyphosate to penetrate human cells more easily.355 356 357 These problems are addressed in the new pesticides regulation 1107/2009, which takes into account the toxicity of the formulation as sold. This alone is reason enough to require that glyphosate herbicides be reviewed under the new regulation without delay.
Glyphosate’s current approval in the EU is based on the 2002 review, carried out under the old pesticides regulation 91/414.240 The 2002 review assesses glyphosate, the glyphosate derivative herbicide glyphosate trimesium, and the glyphosate metabolite (breakdown product) AMPA.
The review exemplifies the general failings of the old pesticides approvals system:
●●Insulation from independent peer reviewed scientific findings
●●Old, outdated, and badly informed claims for glyphosate’s safety go unchallenged
●●Virtually exclusive reliance on industry studies for the safety assessment, with the inherent conflicts of interest
●●Reliance on studies with old and outdated protocols
●●Reliance on dubious and outdated assumptions
●●Lack of transparency
●●Failure to test the complete glyphosate formulations as they are sold.
A detailed breakdown of these factors follows.
12.1 Open peer reviewed scientific literature is denied
There is broad agreement in the scientific community that peer reviewed publication is the best currently available method to ensure reliable scientific data.
There are undoubted flaws with the peer review process – including publication bias, where certain types of results are more likely to be published than others,241 242 243 and pressure being placed on journal editors not to publish, or to retract, certain findings.244 245 246 Some journals have been generated or “captured” by industry and use industry-connected peer reviewers.247
In spite of these problems, the strength of the peer review process is that studies in the open literature can be evaluated by independent experts. Their findings can be confirmed, built upon, or contradicted by further studies.
The public, too, has been educated to respect the peer review process and to expect scientific claims to be validated in this way. The part-industry-funded UK-based group Sense About Science, which calls itself “an independent charitable trust promoting good science and evidence in public debates”248 and promotes the safety of controversial technologies like genetically modified foods,249 set up an entire project to convince the public that peer review is “an essential arbiter of scientific quality”.250 In its guide for the public on peer review, I Don’t Know What to Believe, Sense About Science says:
Unpublished research is no help to anyone. Scientists can’t repeat or use it and as a society we can’t base decisions about our public safety – or our family’s health for example – on work that has a high chance of being flawed.251
Given such influential messages, it would shock the public to realize that in the pesticide approvals process, peer reviewed open literature is not normally considered. The studies on which the 2002 EU review of glyphosate is based, as is the norm with pesticides, were generated and submitted by industry.252 The conclusions about the health hazards of glyphosate in the 2002 EU review are strikingly at variance with the findings from the independent scientific literature, as the analysis below shows.
Genotoxicity
The 2002 review flatly states that glyphosate and glyphosate trimesium are “not genotoxic” (causing damage to DNA). It is difficult to understand how this conclusion could be reached, given that even industry studies from the 1980s found that Roundup caused chromosome aberrations and gene mutations in mice lymphoid cells.253 254
In addition, a number of studies showing that glyphosate and Roundup are genotoxic existed in the peer reviewed literature even at the time of the 2002 review. Findings include:
●●Roundup increases the frequency of gender-linked lethal recessive mutations in fruit flies (these mutations are normally only seen in males).255
●●Roundup increases the frequency of DNA adducts (the binding to genetic material of reactive molecules that lead to mutations) in the liver and kidneys of mice at all three doses tested. The response was dose-dependent.256
●●Roundup causes increased frequency of sister chromatid exchanges in human lymphocytes (white blood cells), even at the lowest dose tested.257
●●Mice injected with glyphosate and Roundup show increased frequency of chromosome damage and increased DNA damage in bone marrow, liver, and kidney.258
Numerous additional recent studies confirm genotoxicity:
●●Roundup damages the DNA in the blood cells of European eels at environmentally relevant concentrations.259
●●Roundup has adverse effects on the cells of various organs in fish exposed at sublethal concentrations of 5–15 ppm (a typical concentration in a post-application site). Effects include hyperplasia (increased proliferation of cells) and increased activity of metabolic enzymes.260
●●Glyphosate-based herbicides cause increased frequency of DNA strand breaks and cell nucleus abnormalities indicative of mutagenic stress in goldfish at low doses (5–15 ppm).261
●●Glyphosate-based herbicides cause DNA damage and endocrine disruption in human cells at levels up to 800 times lower than glyphosate residue levels allowed in some GM crops used for animal feed in the United States.262
●●Glyphosate-based herbicides inhibit RNA transcription and delay hatching in sea urchin embryos at a concentration well below that recommended for commercial spray application. The Roundup surfactant polyoxyethylene amine (POEA) is highly toxic to the embryos when tested alone and so could contribute to the inhibition of hatching.263
●●Glyphosate-based herbicides and glyphosate’s main metabolite (environmental breakdown product), AMPA, alter cell cycle checkpoints in sea urchin embryos by interfering with the physiological DNA repair machinery. Such cell cycle dysfunction is seen from the first cell division in the sea urchin embryos.264 265 266 267 The failure of cell cycle checkpoints is known to lead to genomic instability and the possible development of cancer in humans. Studies on glyphosate and AMPA suggest that the irreversible damage that they cause to DNA may increase the risk of cancer.268 269
●●An epidemiological study in Ecuador found a higher degree of DNA damage in people living in an area that was aerially sprayed with glyphosate compared with those living 80 kilometres away.270
AMPA, glyphosate’s main breakdown product (metabolite), is also genotoxic in isolation. The 2002 review, on the basis of the industry studies, calls AMPA “less toxic than the parent compound”.271 The ECCO Panel states, “AMPA is not of toxicological significance.”272 However, an independent study found that AMPA is genotoxic, damaging DNA in human cells at very low doses and in mice at a dose of 200–400mg/kg.273
Carcinogenicity
The 2002 review claims “no evidence” of carcinogenicity for glyphosate and glyphosate trimesium. But glyphosate was known to have carcinogenic effects long before the 2002 review.
Two long-term studies on rats were conducted in 1979–1981 and 1988–1990.274 The rats received 3, 10 and 32 mg/kg of glyphosate per day in the first study and 100, 410 and 1060 mg/kg per day in the second. The first study found a significant increase in tumours in the testes of rats fed glyphosate, but the same effect was not found in the second test using the higher doses. On this basis, glyphosate was excluded from the carcinogenic category.275 276
This move was based on outdated and incorrect assumptions about toxicology. It used to be thought that toxic effects increased in proportion to dose, and that there is a safe level of a chemical, below which toxic effects are not found. But toxicologists now know that these assumptions are not always true. Some chemicals have more potent effects (notably endocrine effects) at low doses than higher doses.277 In some cases, no safe threshold can be found.278 279 However, regulators have not revised their conclusions on glyphosate based on up-to-date scientific knowledge.
Studies from the independent literature also show that Roundup and glyphosate have carcinogenic effects:
●●Glyphosate induces cancer in mouse skin280
●●Epidemiological studies show a link between Roundup/glyphosate exposure and two types of cancer: multiple myeloma281 and non-Hodgkin’s lymphoma.282 283 284
●●Other studies (mentioned under Genotoxicity, above) show that Roundup, glyphosate, and its metabolite AMPA cause changes to cells and DNA that are known to lead to cancer.285 286 287 288 289 290
Neurotoxicity
The 2002 review of glyphosate claims “no relevant effects” in tests for delayed neurotoxicity. But glyphosate is an organophosphate, a class of chemicals known to have neurotoxic effects, so claims of “no relevant” neurotoxic effects demand a strong and transparent evidence base to back them up.
In fact, studies from the open literature have found neurotoxic effects of glyphosate:
●●An epidemiological study carried out in Minnesota, USA found that the children of pesticide applicators exposed to glyphosate had an increased incidence of neurobehavioral disorders.291
●●In an acute poisoning incident, a man who accidentally sprayed himself with glyphosate developed the neurological disorder Parkinsonism.292
●●A toxicological study on rats found that glyphosate depletes the neurotransmitters serotonin (serotonin is associated with feelings of well-being and is known as the “happiness hormone”) and dopamine.293
●●Glyphosate causes a loss of mitochondrial transmembrane potential (a hallmark of cellular injuries) in rat brain cells.294
●●Glyphosate and Roundup act synergistically with the organophosphate insecticide diazinon in neuroblastoma (nerve cancer) cells. Glyphosate and Roundup become more neurotoxic when the cells have been pre-exposed to diazinon. Roundup is more toxic than glyphosate and produces effects at a concentration as low as 10 ppb, which is equivalent to a glyphosate concentration of 0.5 nM. Unusual dose-response relationships are found with both glyphosate and Roundup, which the authors say merit further investigation as they indicate that the relationship between concentration and toxicity at low concentrations may not be entirely predictable.295
Reproductive and developmental toxicity and endocrine disruption
The 2002 review notes that studies on glyphosate and glyphosate trimesium found reduced pup weight and decrease in litter size and pup body weight gain, but says these effects are confined to high, “parentally toxic doses”. The review adds that effects include lower number of viable foetuses and reduced foetal weight, retarded ossification (bone formation), and higher incidence of skeletal and/or visceral (internal organ) anomalies. Effects of glyphosate trimesium include increased post-implantation losses (miscarriage), reduced foetal weight, and increased incidence of rib “variations” at maternally toxic doses.
The 2002 review gives a developmental NOAEL (the highest level at which the effect being looked for is not found) of 300 mg/kg bw/d for glyphosate and 40 mg/kg bw/d for glyphosate trimesium. However, studies from the open literature have found adverse reproductive and developmental effects, in some cases at much lower levels. While we have discussed some of these studies in the above sections, we provide a comprehensive summary as follows:
●●Glyphosate herbicide alters hormone levels in female catfish and decreases egg viability. The study concludes that the presence of glyphosate in water is harmful to catfish reproduction.296
●●Roundup disrupts production of the steroid hormone progesterone in mouse cells by disrupting expression of a regulatory protein.297
●●Roundup causes decreased sperm numbers and increased abnormal sperms in rats.298
●●A commercial formulation of glyphosate was found to be a potent endocrine disruptor in rats, causing disturbances in their reproductive development after they were exposed during puberty.299
●●In human cells, glyphosate-based herbicides prevent the action of androgens, the masculinising hormones, at levels up to 800 times lower than glyphosate residue levels allowed in some GM crops used for animal feed in the United States. DNA damage is found in human cells treated with glyphosate-based herbicides at these levels. Glyphosate-based herbicides also disrupt the action and formation of estrogens, the feminizing hormones.300 This in vitro study found the first toxic effects of glyphosate-based herbicide at 5 ppm, and the first endocrine disrupting actions at 0.5 ppm – 800 times less than the 400 ppm level authorized by the US Environmental Protection Agency (EPA) in some animal feeds.301 302
●●Glyphosate acts synergistically with estrogen, disrupting estrogen-regulated gene expression in human cells.303
●●Glyphosate is toxic to human placental cells and this effect increases in the presence of Roundup adjuvants. Roundup acts as an endocrine disruptor, inhibiting an enzyme responsible for estrogen production. The authors conclude that Roundup could cause reproductive problems in humans at levels below those used in agriculture.304 The authors suggest that their results could explain epidemiological findings of increased premature births and miscarriages in female members of farming families using glyphosate.305 306
●●Glyphosate and Roundup damage human embryonic cells and placental cells, in concentrations well below those recommended for agricultural use. The study’s authors conclude that Roundup may interfere with human reproduction and embryonic development.307
●●The foetuses of rats fed orally with high doses of Roundup had increased incidence of skeletal malformations.308
●●Roundup causes malformations in frog and chicken embryos at doses much lower than those used in agricultural spraying.309 Malformations were of the craniofacial and neural tube type (of the skull, face, and developing brain and spinal cord).
Conclusion of open peer-reviewed literature on health effects
Both the existing pesticides regulation, 91/414, and the new regulation, 1107/2009, require that a pesticide should not have any harmful effect on human or animal health.310 311 The new regulation is stricter, since “vulnerable groups” must be considered in the human health assessment and known “cumulative and synergistic effects” of the pesticide must be addressed.312 Clearly, glyphosate herbicides do not even meet the requirements of the old regulation, so their approval should be reviewed immediately with a view to restricting or banning their use.
12.2. Outdated and badly informed claims go unchallenged
The discussion between industry, the rapporteur Germany, member states, and the ECCO Panel that led to the 2002 review includes numerous old, outdated, and badly informed claims for the safety of glyphosate and its breakdown product AMPA. Many of these claims have been superseded or discredited by independent studies – but they passed through the review process unchallenged and have remained in place in the regulatory system ever since. Similarly, concerns are raised but not followed up.
Anyone who is informed about the current state of knowledge on glyphosate cannot fail to be alarmed by these claims and uninvestigated concerns. There are too many to cover fully in this report, but a few examples follow.
Unresolved concerns about salivary gland lesions
Concerns about repeated findings of salivary gland lesions in experimental animals treated with glyphosate are expressed throughout the DAR materials and mentioned in the 2002 final review report. However, nobody seems to know what the lesions mean, and no attempt is made to find out. A comment by the ECCO Panel is typical:
Histological effects were observed in salivary glands in the 6 and 12 month dog study, however, since these lesions were considered without functional consequence or long term effects they were not considered to be adverse.313
The regulators should have insisted that these experiments be continued for a longer period, so that the true consequences of these lesions were revealed. Salivary gland lesions can be pre-cancerous.
Failure to consider endocrine disruption
The ECCO Panel says, “Various literature references suggest that glyphosate is an endocrine disruptor.” Again, the panel has no idea what to make of these findings: “The group recognised that there was no guidance available regarding how such information should be used so it was agreed that the rapporteur should consult the Chairperson of the mammalian toxicology meeting at the BBA [German Federal Ministry for Food, Agriculture and Consumer Protection] to see if this is a concern.”314 The final review report of 2002 does not mention endocrine disruption – sufficient reason in itself why the current approval of glyphosate is inadequate. However, independent studies show that glyphosate herbicides are endocrine disruptors.315 316 317
Failure to consider the impact of glyphosate-resistant weeds
The DAR and 2002 review report were compiled before the problem of glyphosate-resistant weeds became widespread. Monsanto claims in the DAR materials that it has tested over 500 samples and found that only two locations in Australia were affected. The plant involved was an annual rye grass.318 The UK Pesticides Safety Directorate (PSD) comments, “It is likely that resistance is low, although there have been two further reports of possible cases in America and Asia.”319 Since the EU Commission’s 2002 approval of glyphosate, a large number of independent studies and media reports have documented the extensive and serious problems caused by glyphosate-resistant superweeds, especially in North and South America. 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 Glyphosate’s current approval does not take this into consideration and a critical re-assessment is urgently needed.
In addition, the risk assessment should consider the inevitable shift in herbicide use after glyphosate-resistant weed populations become widespread. The published studies and articles cited above show that weeds evolve resistance to glyphosate within 2–6 years of cultivation of genetically modified (GM) Roundup Ready crops. This is less time than the approval period of a pesticide in the EU – formerly ten years, now 15 years. Once resistant weed populations are established, farmers have to resort to other potentially even more toxic herbicides, including 2,4-D, to try to control glyphosate-resistant weeds.335 336 337 338
The chemical companies Dow, DuPont, Bayer, BASF, and Syngenta have responded to the superweeds problem by “engineering crop varieties that will enable farmers to spray on the tough old weedkillers freely, instead of having to apply them surgically in order to spare crops”, according to a report in the Wall Street Journal.339 Bayer has patented a GM soybean with tolerance to the herbicide glufosinate ammonium.340 Studies show that glufosinate ammonium is a neurotoxin341 and causes birth defects in mice.342 Monsanto plans to release a dicamba-resistant GM soybean in 2013.343 These developments are relevant to Europe as Romania is lobbying the EU for permission to cultivate GM soy.344
A new generation of herbicide-resistant crops is being engineered with stacked traits to tolerate multiple herbicides.345 But weed scientists have commented that these new GM crops will only buy growers a little more time until weeds evolve resistance to other herbicides.346 In fact, weed species resistant to dicamba and 2,4-D already exist.347 348
The existing approval of glyphosate fails to take into consideration the chemical treadmill resulting from the emergence of glyphosate-resistant weeds – and the consequences to human health and the environment. While a full consideration of this issue is beyond the scope of this report, it needs to be addressed in the risk assessment of glyphosate as it is a hazard inherent in the use of the herbicide.
Incorrect claim about biological availability of glyphosate
The UK Pesticides Safety Directorate (PSD) notes that the issue of a waiting period between glyphosate spraying and re-entry into fields in order to protect humans, livestock, and plants, is not properly dealt with in Germany’s DAR. However, the PSD immediately dismisses this concern:
This should not be an issue for glyphosate as it is not usually biologically available once it contacts soil.349
But this claim was not true even at the time of the DAR. A 1983 study showed that glyphosate persists in sandy loam soil and is not inactivated in the 120 days prior to planting. Plants growing in the glyphosate-treated soil showed decreased nitrogen fixation, root nodule numbers and root weights – indicating that glyphosate was biologically available and toxic to plants 120 days after application.350
A new risk assessment should address the issue of the re-entry period.
Incorrect claim about biological activity of AMPA
Monsanto says AMPA’s long persistence in soil is of no “regulatory concern” because “AMPA is biologically inactive”.351 But a 2004 study showed that AMPA causes injury to glyphosate-tolerant and non-glyphosate-tolerant soybeans. Findings are the same when the AMPA is deliberately applied and when it forms from the breakdown of applied glyphosate. The study concludes that soybean injury to glyphosate-tolerant soybeans from glyphosate is due to AMPA formed from glyphosate degradation.352 Therefore AMPA is biologically active.
It is clear that the documents on which the existing approval of glyphosate is based are out of date and out of touch with current scientific knowledge and farmer experience.
12.3. Industry tests have conflicts of interest
There are clear conflicts of interest in the 2002 review of glyphosate in that the companies that commissioned the tests and submitted the data also market the product. The fact that this is the norm in pesticides approvals does not make it acceptable. The main data submitters were Monsanto, Cheminova, Feinchemie, and Syngenta (formerly Zeneca).353 These companies manufacture and/or sell glyphosate herbicide. Monsanto, Syngenta, and Dow AgroScience (another data submitter) also sell GM glyphosate-tolerant seeds.
12.4. Industry tests are old and use outdated protocols
Anyone who is familiar with the rapid evolution of scientific knowledge relating to glyphosate over the past decade would be shocked to see that its current approval depends mostly on studies dating from the 1990s – some from as far back as the 1970s and 1980s.
In the 1990s glyphosate was still frequently claimed to be safe and environmentally friendly. Few independent studies were in existence to contradict these claims. Even so, by 1996, independent science had moved on to such an extent that a New York court ruled that Monsanto was no longer allowed to claim that Roundup was “safe, non-toxic, harmless or free from risk”, or as biodegradable.354 During the 2000s, a battery of independent scientific studies showed serious toxic effects from Roundup and glyphosate. None of this knowledge has made its way through to the regulatory system.
12.5. The approvals system is not transparent
In theory, the industry dossier of studies on a pesticide and the regulators’ discussions and justifications for their final decision are in the public domain. In practice, it is not so straightforward. The authors of this report had difficulty obtaining the materials. When they were finally obtained, a part of Germany’s DAR was withheld. The materials were confusingly presented and difficult to interpret. In the DAR itself, justifications for important decisions are not recorded in detail.
Data protection is claimed for many of the industry studies in the 2002 review of glyphosate on grounds of commercial confidentiality. This is standard practice, ostensibly because it prevents data from getting into the hands of competitor companies. Unfortunately, it also prevents the public and independent scientists from evaluating the data. So tests of unknown quality and unknown reliability are used to allow pesticides onto the market.
There is also no transparent system in place for considering independent scientific data that comes to light after the approval, as is clear from the case of Carrasco’s study.
12.6. The complete formulations as they are sold were not tested
The existing review of glyphosate fails to take into account the complete formulations as they are currently sold. Glyphosate herbicides contain adjuvants (added ingredients) which are themselves toxic and which can act synergistically with glyphosate to increase its toxicity. Studies show that Roundup is more toxic than glyphosate alone because the adjuvants enable the glyphosate to penetrate human cells more easily.355 356 357 These problems are addressed in the new pesticides regulation 1107/2009, which takes into account the toxicity of the formulation as sold. This alone is reason enough to require that glyphosate herbicides be reviewed under the new regulation without delay.
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13. Conclusions and recommendations
The existing approval of glyphosate and Roundup is out of date and scientifically unsupportable. The safety assessment began badly, with a dossier of outdated industry-sponsored tests, and was progressively weakened at each stage:
●●The German government produced a draft assessment report (DAR) that minimized the harm shown even in inadequate industry studies and set a dangerously high ADI for glyphosate.
●●Germany’s DAR was in turn whitewashed by the EU’s scientific review ECCO Panel.
●●Finally, the EU Commission’s DG SANCO accepted these misleading reports in its 2002 review, minimizing the reproductive and developmental effects of glyphosate.
Together, these bodies must share responsibility for making claims about the safety of glyphosate that were contradicted even by the scientific knowledge current at the time. Now that scientific knowledge has moved on, glyphosate and Roundup formulations must be reviewed urgently, taking into consideration all independent scientific evidence.
The new pesticides regulation, if implemented objectively and in timely fashion, would likely result in a ban on glyphosate herbicides. But the Commission and EFSA have abnegated their responsibility to the public in allowing glyphosate a free regulatory ride until 2015, with the possibility of no review under up-to-date data requirements until 2030. Their actions flout a democratically established law and put public health at risk.
13.1. Recommendations on Roundup and glyphosate
In the interests of protecting public health, we call upon the Commission to implement the following measures on Roundup and glyphosate:
●●Order an immediate withdrawal of Roundup and glyphosate until a new review can be carried out, based on the full range of up-to-date tests.
●●Assess all adverse effects of Roundup and glyphosate found in the open peer reviewed scientific literature.
●●Base industry tests on the findings in open literature, not only on generalized data requirements. For example, the experiments of Dallegrave should be repeated with modifications.
●●Ensure that regulators look critically at the applications for GM Roundup Ready crops that are in the EU approvals pipeline instead of repeating outdated and misleading assurances about the safety of glyphosate and Roundup.
13.2. Recommendations on pesticides regulation
On pesticides regulation in general, we call upon the Commission to:
●●Hold an urgent debate with the full range of stakeholders on the question: What is the point of independent science when regulators ignore it in every assessment of a pesticide? Billions of pounds of taxpayers’ money go into public sector research. In our view, this type of research, when peer reviewed and published, represents the most reliable, independent, and up-to-date knowledge on pesticides. But it appears that the Commission and regulatory bodies and agencies disagree with this view. Currently, independent scientists are wasting their time and energy as far as regulation is concerned. The Commission and other regulatory bodies must publicly explain their attitude to independent science.
●●Ensure that all studies from the open scientific literature are considered in the risk assessment. Industry and the rapporteur state must not be allowed to “cherry-pick” acceptable studies on the grounds of exposure route, length of study, choice of experimental animal, etc. If there are genuine questions about the methodology of a study finding adverse effects, regulators must order it to be repeated with the desired modifications.
●●Publish all industry studies on the internet as a matter of principle.
●●Pay independent scientists who are actively researching and publishing in the field to review industry studies and studies from the open literature on the pesticide under review.
●●Ensure that the risk assessment is based on the lowest NOAEL found in any study.
●●Ensure that “reviews” or comments on studies from the open literature are written by named experts who are accountable for their views.
●●Replace the current system, in which industry directly pays contract labs to carry out regulatory studies on pesticides, with a system in which industry pays into a central fund for the studies and the regulators contract out the work to independent researchers.
●●Get industry out of the pesticides regulatory process. Industry should provide the pesticide and its basic compositional information – but leave the testing and evaluation (including the peer-reviewed scientific literature search) to regulators and independent scientists.
●●Introduce mandatory disclosure of minutes and conclusions of meetings between EU Commission/EFSA and all stakeholders, including industry-affiliated bodies like the International Life Sciences Institute.
●●Ensure that all meetings between EFSA and industry or industry-affiliated bodies such as the International Life Sciences Institute (ILSI) are open to the full range of stakeholders, including NGOs and representatives of the general public.
●●Ensure full transparency of the decision-making procedure, from the initial submission of the dossier by industry to the final decision made on the pesticide.
Our examination of the evidence leads us to the conclusion that the current approval of glyphosate and Roundup is deeply flawed and unreliable. What is more, we have learned from experts familiar with pesticide assessments and approvals that the case of glyphosate is not unusual. They say that the approvals of numerous pesticides rest on data and risk assessments that are just as scientifically flawed, if not more so. This is all the more reason why the Commission must urgently review glyphosate and other pesticides according to the most rigorous and up-to-date standards.
13.3. Recommendations to the public
Until the pesticide assessment process is fundamentally reformed, we recommend to the public that they do not rely on the messages of governments or industry about pesticide safety. Instead, they should take measures to protect themselves against the harmful effects of Roundup/glyphosate and other pesticides. These include:
●●Avoiding using and exposing themselves to pesticides, insofar as they have choice in the matter.
●●Lobbying local authorities, farmers, and other pesticide users to disclose what they are spraying and when.
●●Lobbying local authorities and other “cosmetic” users of Roundup/glyphosate and other pesticides to switch to less toxic methods of weed and pest control.
●●Writing to garden centres, supermarkets, and other stores asking them not to sell Roundup/glyphosate and other pesticides.
●●Supporting citizen “truth-in-labelling” schemes to inform consumers about the true risks of pesticides through accurate product labelling.
Note on citations of Germany’s DAR on glyphosate
In the interests of transparency and so that readers can check the accuracy of our statements, we have uploaded onto the Internet those parts of Germany’s draft assessment report (DAR) on glyphosate that we cite in the text of our report. Please note that page numbers in the references below refer to the page numbers of the pdf document, not the page numbers printed on the original documents that make up the DAR.
Our citations of the DAR begin as follows:
Then each citation specifies a pdf file within the DAR. The URLs for each pdf file we have uploaded are as follows:
●●Volume1_Glyphosat_02.pdf: http://www.scribd.com/doc/57155781
●●Volume 2, Part A, Annex A: List of Tests and Studies: http://www.scribd.com/doc/57156365
●●Volume 3-1_Glyphosat_05.pdf: http://www.scribd.com/doc/57155616
●●Volume 3-1_Glyphosate_04.pdf: http://www.scribd.com/doc/57155694
●●FullReport_Glyphosat_03.pdf: http://www.scribd.com/doc/57155540
●●FullReport_Glyphosat_04.pdf: http://www.scribd.com/doc/57155451
●●FullReport_Glyphosat_05.pdf: http://www.scribd.com/doc/57155341
The existing approval of glyphosate and Roundup is out of date and scientifically unsupportable. The safety assessment began badly, with a dossier of outdated industry-sponsored tests, and was progressively weakened at each stage:
●●The German government produced a draft assessment report (DAR) that minimized the harm shown even in inadequate industry studies and set a dangerously high ADI for glyphosate.
●●Germany’s DAR was in turn whitewashed by the EU’s scientific review ECCO Panel.
●●Finally, the EU Commission’s DG SANCO accepted these misleading reports in its 2002 review, minimizing the reproductive and developmental effects of glyphosate.
Together, these bodies must share responsibility for making claims about the safety of glyphosate that were contradicted even by the scientific knowledge current at the time. Now that scientific knowledge has moved on, glyphosate and Roundup formulations must be reviewed urgently, taking into consideration all independent scientific evidence.
The new pesticides regulation, if implemented objectively and in timely fashion, would likely result in a ban on glyphosate herbicides. But the Commission and EFSA have abnegated their responsibility to the public in allowing glyphosate a free regulatory ride until 2015, with the possibility of no review under up-to-date data requirements until 2030. Their actions flout a democratically established law and put public health at risk.
13.1. Recommendations on Roundup and glyphosate
In the interests of protecting public health, we call upon the Commission to implement the following measures on Roundup and glyphosate:
●●Order an immediate withdrawal of Roundup and glyphosate until a new review can be carried out, based on the full range of up-to-date tests.
●●Assess all adverse effects of Roundup and glyphosate found in the open peer reviewed scientific literature.
●●Base industry tests on the findings in open literature, not only on generalized data requirements. For example, the experiments of Dallegrave should be repeated with modifications.
●●Ensure that regulators look critically at the applications for GM Roundup Ready crops that are in the EU approvals pipeline instead of repeating outdated and misleading assurances about the safety of glyphosate and Roundup.
13.2. Recommendations on pesticides regulation
On pesticides regulation in general, we call upon the Commission to:
●●Hold an urgent debate with the full range of stakeholders on the question: What is the point of independent science when regulators ignore it in every assessment of a pesticide? Billions of pounds of taxpayers’ money go into public sector research. In our view, this type of research, when peer reviewed and published, represents the most reliable, independent, and up-to-date knowledge on pesticides. But it appears that the Commission and regulatory bodies and agencies disagree with this view. Currently, independent scientists are wasting their time and energy as far as regulation is concerned. The Commission and other regulatory bodies must publicly explain their attitude to independent science.
●●Ensure that all studies from the open scientific literature are considered in the risk assessment. Industry and the rapporteur state must not be allowed to “cherry-pick” acceptable studies on the grounds of exposure route, length of study, choice of experimental animal, etc. If there are genuine questions about the methodology of a study finding adverse effects, regulators must order it to be repeated with the desired modifications.
●●Publish all industry studies on the internet as a matter of principle.
●●Pay independent scientists who are actively researching and publishing in the field to review industry studies and studies from the open literature on the pesticide under review.
●●Ensure that the risk assessment is based on the lowest NOAEL found in any study.
●●Ensure that “reviews” or comments on studies from the open literature are written by named experts who are accountable for their views.
●●Replace the current system, in which industry directly pays contract labs to carry out regulatory studies on pesticides, with a system in which industry pays into a central fund for the studies and the regulators contract out the work to independent researchers.
●●Get industry out of the pesticides regulatory process. Industry should provide the pesticide and its basic compositional information – but leave the testing and evaluation (including the peer-reviewed scientific literature search) to regulators and independent scientists.
●●Introduce mandatory disclosure of minutes and conclusions of meetings between EU Commission/EFSA and all stakeholders, including industry-affiliated bodies like the International Life Sciences Institute.
●●Ensure that all meetings between EFSA and industry or industry-affiliated bodies such as the International Life Sciences Institute (ILSI) are open to the full range of stakeholders, including NGOs and representatives of the general public.
●●Ensure full transparency of the decision-making procedure, from the initial submission of the dossier by industry to the final decision made on the pesticide.
Our examination of the evidence leads us to the conclusion that the current approval of glyphosate and Roundup is deeply flawed and unreliable. What is more, we have learned from experts familiar with pesticide assessments and approvals that the case of glyphosate is not unusual. They say that the approvals of numerous pesticides rest on data and risk assessments that are just as scientifically flawed, if not more so. This is all the more reason why the Commission must urgently review glyphosate and other pesticides according to the most rigorous and up-to-date standards.
13.3. Recommendations to the public
Until the pesticide assessment process is fundamentally reformed, we recommend to the public that they do not rely on the messages of governments or industry about pesticide safety. Instead, they should take measures to protect themselves against the harmful effects of Roundup/glyphosate and other pesticides. These include:
●●Avoiding using and exposing themselves to pesticides, insofar as they have choice in the matter.
●●Lobbying local authorities, farmers, and other pesticide users to disclose what they are spraying and when.
●●Lobbying local authorities and other “cosmetic” users of Roundup/glyphosate and other pesticides to switch to less toxic methods of weed and pest control.
●●Writing to garden centres, supermarkets, and other stores asking them not to sell Roundup/glyphosate and other pesticides.
●●Supporting citizen “truth-in-labelling” schemes to inform consumers about the true risks of pesticides through accurate product labelling.
Note on citations of Germany’s DAR on glyphosate
In the interests of transparency and so that readers can check the accuracy of our statements, we have uploaded onto the Internet those parts of Germany’s draft assessment report (DAR) on glyphosate that we cite in the text of our report. Please note that page numbers in the references below refer to the page numbers of the pdf document, not the page numbers printed on the original documents that make up the DAR.
Our citations of the DAR begin as follows:
Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Released by the German Federal Agency for Consumer Protection and Food Safety, BVL.
Then each citation specifies a pdf file within the DAR. The URLs for each pdf file we have uploaded are as follows:
●●Volume1_Glyphosat_02.pdf: http://www.scribd.com/doc/57155781
●●Volume 2, Part A, Annex A: List of Tests and Studies: http://www.scribd.com/doc/57156365
●●Volume 3-1_Glyphosat_05.pdf: http://www.scribd.com/doc/57155616
●●Volume 3-1_Glyphosate_04.pdf: http://www.scribd.com/doc/57155694
●●FullReport_Glyphosat_03.pdf: http://www.scribd.com/doc/57155540
●●FullReport_Glyphosat_04.pdf: http://www.scribd.com/doc/57155451
●●FullReport_Glyphosat_05.pdf: http://www.scribd.com/doc/57155341
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References
1. Krebs, C. 2011. Farmers look to broader strategies to battle weeds. Ag Journal. March 11. http://bit.ly/ehzYie. This article says, “Glyphosate now accounts for $5.5 billion in sales worldwide, more than all other herbicides combined.”
2. Paganelli, A., Gnazzo, V. et al. 2010. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signaling. Chem Res Toxicol 23(10): 1586–1595.
3. Paganelli, A., Gnazzo, V. et al. 2010. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signaling. Chem Res Toxicol 23(10): 1586–1595.
4. Benbrook, C.M. 2009. Impacts of genetically engineered crops on pesticide use in the United States: The first thirteen years. The Organic Center, November. http://www.organic-center.org/reportfil ... Report.pdf
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8. Paganelli, A., Gnazzo, V. et al. 2010. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signaling. Chem Res Toxicol 23(10): 1586–1595.
9. Aranda, D. 2010. Interview with Prof Andrés Carrasco on his research showing Roundup link with birth defects. August. http://www.gmwatch.org/latest-listing/1 ... tems/12509
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11. For further discussion of exposure routes and doses, see Sections 6 and 7.
12. GMO Compass. 2010. Soybeans. September 2. http://www.gmo-compass.org/eng/database ... ybean.html
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14. Tremopoulos, M. 2010. Safety standards regarding widely used pesticide. Parliamentary question to the Commission for written answer, European Parliament, Brussels, October 1. http://www.europarl.europa.eu/sides/getDoc.do?
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15. Dalli, J. 2010. Answer given by Mr Dalli on behalf of the Commission. Parliamentary questions, European Parliament, Brussels, November 12. http://www.europarl.europa.eu/sides/
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16. Dalli, J. 2010. Answer given by Mr Dalli on behalf of the Commission. Parliamentary questions, European Parliament, Brussels, November 12. http://www.europarl.europa.eu/sides/
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17. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final, January 21. http://www.egeis.org/home/glyph_info/li ... ate_en.pdf
18. European Commission. 2010. Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances. OJ L 230, 19.8.1991.
19. Dalli, J. 2010. Answer given by Mr Dalli on behalf of the Commission. Parliamentary questions, European Parliament, Brussels, November 12. http://www.europarl.europa.eu/sides/
getAllAnswers.do?reference=E-2010-7874&language=ET
20. Tremopoulos, M. 2010. Error in the Commission’s answer to my written question on glyphosate. Parliamentary question, European Parliament, Brussels, December 15. http://www.europarl.europa.eu/sides/getDoc.do?pubRef=
-//EP//TEXT+WQ+P-2010-010522+0+DOC+XML+V0//EN&language=EN
21. Dalli, J. 2011. Answer given by Mr Dalli on behalf of the Commission. Parliamentary questions, European Parliament, Brussels, January 17.
22. European Council. 1991. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
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23. European Parliament and Council. 2009. Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union, November 24.
24. “Grey literature” is a term used to describe documents produced and published by government agencies, academic institutions and other groups that are not distributed or indexed by commercial publishers and so are difficult to obtain. Grey literature stands in stark contrast to peer reviewed open scientific literature, which has been scrutinized and judged worthy of publication by fellow scientists – and can be read by the wider public. The pesticide approvals process is heavily reliant on grey literature.
25. European Parliament and Council. 2009. Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union, November 24: 12.
26. European Parliament and Council. 2009. Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union, November 24.
27. European Commission. 2010. Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances. OJ L 230, 19.8.1991.
28. European Commission. 2010. Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances. OJ L 230, 19.8.1991.
29. EurActiv.com. 2011. EU lawyers struggle with new “comitology” rules. February 21. http://www.euractiv.com/en/
future-eu/eu-lawyers-struggle-new-comitology-rules-news-502310
30. Joermann, G. 2010. Letter from BVL, Germany to Friends of the Earth Germany. December 9.
31. European Commission. 2010. Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances. OJ L 230, 19.8.1991.
32. Pesticides Action Network Europe and Greenpeace. 2011. Re-assessment of harmful herbicide silently postponed in Europe. Press release. May 4. http://gmwatch.eu/latest-listing/1-news-items/13118
33. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
34. Jørgensen, D. 2011. Data requirements for active substances by June 2011. Parliamentary question to the Commission, European Parliament, Brussels, January 24.
35. European Parliament and Council. 2009. Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union, November 24. Article 84: L 309/38.
36. European Parliament and Council. 2010. Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances. Official Journal of the European Union, December 8. Annex I: L 322/18.
37. European Commission. 2010. Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances. OJ L 230, 19.8.1991.
38. Dalli, J. 2011. Answer given by Mr Dalli on behalf of the Commission to written question from Dan Jørgensen. April 5. http://bit.ly/kCJakw
39. EFSA. 2011. Guidance: Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092.
40. European Parliament and Council. 2009. Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the European Union, November 24. Paragraph (15): L 309/2.
41. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
42. EU Commission. 2008. Regulation 33/2008. January 17. http://www.pesticides.gov.uk/uploadedfiles/
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43. Pesticides Action Network Europe. 2011. Resubmission and other loopholes in EU approval of pesticides. http://www.pan-europe.info/Campaigns/ch ... holes.html
44. BVL, Germany. 2010. Glyphosate – Comments from Germany on the paper by Paganelli, A. et al. (2010): “Glyphosate-based Herbicides Produce Teratogenic Effects on Vertebrates by Impairing Retinoic Acid Signaling”. October 19. http://www.powerbase.info/index.php/Fil ... anelli.pdf
45. BVL, Germany. 2010. Glyphosate – Comments from Germany on the paper by Paganelli, A. et al. (2010): “Glyphosate-based Herbicides Produce Teratogenic Effects on Vertebrates by Impairing Retinoic Acid Signaling”. October 19: 2. http://www.powerbase.info/index.php/Fil ... anelli.pdf
46. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 12. http://www.egeis.org/home/glyph_info/li ... ate_en.pdf
47. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607–608.
48. Carrasco, A. E. 2011. Reply to the letter to the editor regarding our article (Paganelli et al., 2010). Chem Res Toxicol 24(5): 610–613.
49. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607.
50. European Commission. 1998. Glyphosate. Reasoned statement of the overall conclusions drawn by the rapporteur member state. In: Glyphosate DAR, released by German government agency BVL on CD, Volume1_Glyphosat_02.pdf: p. 9 of the pdf.
51. European Commission. 1998. Glyphosate. Reasoned statement of the overall conclusions drawn by the rapporteur member state. In: Glyphosate DAR, released by German government agency BVL on CD, Volume1_Glyphosat_02.pdf: p. 9 of the pdf.
52. Paumgartten, F. J. 2010. Influence of maternal toxicity on the outcome of developmental toxicity studies. J Toxicol Environ Health A 73(13-14): 944-951.
53. Beyer, B. K. et al. 2011. ILSI/HESI maternal toxicity workshop summary: Maternal toxicity and its impact on study design and data interpretation. Birth Defects Research Part B: Developmental and Reproductive Toxicology 92: 36–51. February. http://onlinelibrary.wiley.com/doi/10.1 ... stract#fn1
54. There is pressure on regulators from industry and the animal rights movement to reduce animal testing in general and to reduce the number of animals. However, if society wishes to use toxics in food production, animal toxicological testing appears to be indispensable for the foreseeable future. And if animals are to be used in toxicological testing, it is vital that their lives are not wasted – in other words, that the results are as reliable as possible.
55. This is one of the major failures of existing risk assessment: it does not test the toxicity of real-life human exposures. Epidemiological studies do, but they are often dismissed by regulators because they can only show an association between exposure to a chemical and an effect, not a definite cause and effect relationship – so there is always the possibility that an agent other than the suspect chemical was the culprit.
56. Dallegrave, E., Mantese, F. D. et al. 2007. Pre- and postnatal toxicity of the commercial glyphosate formulation in Wistar rats. Arch Toxicol 81: 665–673.
57. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
58. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
59. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 25 of the pdf.
60. Myers, P., Hessler, W. 2007. Does the dose make the poison? Extensive results challenge a core assumption in toxicology. OurStolenFuture.org, May 25.
61. Welshons, W. V., Thayer, K. A. et al. 2003. Large effects from small exposures. I. Mechanisms for endocrine-disrupting chemicals with estrogenic activity. Environ Health Perspect 111(8): 994-1006.
62. Wetherill, Y. B., Petre, C. E. et al. 2002. The xenoestrogen bisphenol A induces inappropriate androgen receptor activation and mitogenesis in prostatic adenocarcinoma cells. Mol Cancer Ther 1(7): 515-524.
63. Gierthy, J. F. 2002. Testing for endocrine disruption: how much is enough? Toxicol Sci 68(1): 1-3.
64. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
65. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
66. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 18 of the pdf.
67. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 25 of the pdf.
68. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
69. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 19 of the pdf.
70. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
71. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
72. Maltoni, C., Soffritti, M. et al. 1999. The scientific and methodological bases of experimental studies for detecting and quantifying carcinogenic risks. Ann N Y Acad Sci 895: 10-26.
73. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 45 of the pdf.
74. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 19 of the pdf.
75. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 10 of the pdf.
76. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
77. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 13 of the pdf.
78. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 13 of the pdf.
79. Krieger, R. I. (ed.). 2001. Handbook of Pesticide Toxicology: Principles. Elsevier Inc.: 1185.
80. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf. Emphasis ours.
81. EU Commission. 1999. ECCO Peer Review Meetings: Full Report on Glyphosate. Appendix 1: ECCO 78 reporting table 4, Mammalian toxicity. March 8. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_03.pdf: p. 30 of the pdf.
82. Yoshimura, I., Matsumoto, K. 1994. Notes on the use of historical controls. Environ Health Perspect 102 Suppl 1: 19-23.
83. Cuffe, R. L. 2011. The inclusion of historical control data may reduce the power of a confirmatory study. Stat Med. March 22.
84. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 12. http://www.egeis.org/home/glyph_info/li ... ate_en.pdf
85. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 41 of the pdf.
86. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
87. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 13. http://www.egeis.org/home/glyph_info/li ... ate_en.pdf
88. While this may be common practice in setting ADIs, we would argue that it is without scientific justification and is grounds for reviewing glyphosate on a more scientifically rigorous basis.
89. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
90. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf. Note: Germany identifies this Monsanto-sponsored study by Lankas with the words, “highest dose”, suggesting that it is the study it used to set the ADI. This is confirmed in its further comment on this study (see Glyphosate DAR, Volume 3-1_Glyphosate_04.pdf, pp. 28–29 of the pdf). Confusingly, however, Germany goes on to insist that its suggested ADI was not based “on one single study only” but on an assessment of all the long-term studies on rats (see Glyphosate DAR, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf).
91. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
92. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 42–44 of the pdf.
93. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 44 of the pdf.
94. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
95. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 42–44 of the pdf.
96. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
97. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 42 of the pdf.
98. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 42 of the pdf.
99. Romano, R. M., Romano, M. A. et al. 2010. Prepubertal exposure to commercial formulation of the herbicide Glyphosate alters testosterone levels and testicular morphology. Archives of Toxicology 84(4): 309–317.
100. Benedetti, A. L., Vituri, C. d. L. et al. 2004. The effects of sub-chronic exposure of Wistar rats to the herbicide Glyphosate-Biocarb. Toxicol Lett 153(2): 227–232.
101. Huff, J., Jacobson, M. F. et al. 2008. The limits of two-year bioassay exposure regimens for identifying chemical carcinogens. Environ Health Perspect 116(11): 1439–1442.
102. BASF. 2008. Minimise risk – maximise benefits. 15. http://bit.ly/l07Upp
103. BfR. 2011. Regulatory definition of an endocrine disruptor in relation to potential threat to human health. May 16. http://bit.ly/iFO1hL
104. Michaels, D. 2008. Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health. Oxford University Press.
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133. Myers, J. P., Vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315.
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135. Saltmiras, D., Bus, J. S. et al. 2011. Letter to the editor regarding the article by Paganelli et al. Chem Res Toxicol 24(5): 607–608
136. Myers, J. P., Vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315.
137. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
138. Tweedale, A. C. 2011. Uses of ‘Good Laboratory Practices’ by regulated industry and agencies, and the safety of bisphenol A. J Epidemiol Community Health 65: 475–476.
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140. Personal email communication, December 2010.
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147. The non-GLP status of these studies is shown in: Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Volume 2, Part A, Annex A: List of Tests and Studies. In: Glyphosate DAR, released by German government agency BVL on CD.
148. EFSA. 2011. Guidance: Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092: 28.
149. Klimisch, H. J., Andreae, M. et al. 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25(1): 1-5.
150. For more on Regulatory Toxicology and Pharmacology, see Section 4.
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153. EFSA. 2011. Guidance: Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092: 16.
154. EFSA. 2011. Guidance: Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092: 16.
155. vom Saal, F. S. and Hughes, C. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
156. vom Saal, F. S. and Hughes, C. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
157. Myers, J. P., vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315
158. Myers, J. P., vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 314.
159. Myers, J. P., vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309.
160. Myers, J. P., vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 314.
161. EFSA. 2006. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to 2,2-Bis(4-hydroxyphenyl)propane (Bisphenol A). Question number EFSA-Q-2005-100. Adopted on 29 November 2006. The EFSA Journal (2006) 428.
162. vom Saal, F. S. and C. Hughes. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
163. Hamilton, R. 2010. No plans to extend bisphenol A ban, says European Commission. FoodQualityNews.com, 30 November. http://www.foodqualitynews.com/Legislation/
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164. EFSA. 2006. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to 2,2-Bis(4-hydroxyphenyl)propane (Bisphenol A). Question number EFSA-Q-2005-100. Adopted on 29 November 2006. The EFSA Journal (2006) 428.
165. BVL, Germany. 2010. Glyphosate – Comments from Germany on the paper by Paganelli, A. et al. (2010): “Glyphosate-based Herbicides Produce Teratogenic Effects on Vertebrates by Impairing Retinoic Acid Signaling”. October 19. http://www.powerbase.info/index.php/Fil ... anelli.pdf
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24. “Grey literature” is a term used to describe documents produced and published by government agencies, academic institutions and other groups that are not distributed or indexed by commercial publishers and so are difficult to obtain. Grey literature stands in stark contrast to peer reviewed open scientific literature, which has been scrutinized and judged worthy of publication by fellow scientists – and can be read by the wider public. The pesticide approvals process is heavily reliant on grey literature.
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32. Pesticides Action Network Europe and Greenpeace. 2011. Re-assessment of harmful herbicide silently postponed in Europe. Press release. May 4. http://gmwatch.eu/latest-listing/1-news-items/13118
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55. This is one of the major failures of existing risk assessment: it does not test the toxicity of real-life human exposures. Epidemiological studies do, but they are often dismissed by regulators because they can only show an association between exposure to a chemical and an effect, not a definite cause and effect relationship – so there is always the possibility that an agent other than the suspect chemical was the culprit.
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74. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 19 of the pdf.
75. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 10 of the pdf.
76. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf.
77. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 13 of the pdf.
78. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 13 of the pdf.
79. Krieger, R. I. (ed.). 2001. Handbook of Pesticide Toxicology: Principles. Elsevier Inc.: 1185.
80. EU Commission. 1999. Glyphosate: Comments from Pesticides Safety Directorate, York, UK, on EC Review Monographs for Glyphosate and Glyphosate Trimesium, March 24. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_05.pdf: p. 26 of the pdf. Emphasis ours.
81. EU Commission. 1999. ECCO Peer Review Meetings: Full Report on Glyphosate. Appendix 1: ECCO 78 reporting table 4, Mammalian toxicity. March 8. In: Glyphosate DAR, released by German government agency BVL on CD, FullReport_Glyphosat_03.pdf: p. 30 of the pdf.
82. Yoshimura, I., Matsumoto, K. 1994. Notes on the use of historical controls. Environ Health Perspect 102 Suppl 1: 19-23.
83. Cuffe, R. L. 2011. The inclusion of historical control data may reduce the power of a confirmatory study. Stat Med. March 22.
84. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 12. http://www.egeis.org/home/glyph_info/li ... ate_en.pdf
85. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 41 of the pdf.
86. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
87. European Commission Health & Consumer Protection Directorate-General. 2002. Review report for the active substance glyphosate. 6511/VI/99-final. January 21: 13. http://www.egeis.org/home/glyph_info/li ... ate_en.pdf
88. While this may be common practice in setting ADIs, we would argue that it is without scientific justification and is grounds for reviewing glyphosate on a more scientifically rigorous basis.
89. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
90. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf. Note: Germany identifies this Monsanto-sponsored study by Lankas with the words, “highest dose”, suggesting that it is the study it used to set the ADI. This is confirmed in its further comment on this study (see Glyphosate DAR, Volume 3-1_Glyphosate_04.pdf, pp. 28–29 of the pdf). Confusingly, however, Germany goes on to insist that its suggested ADI was not based “on one single study only” but on an assessment of all the long-term studies on rats (see Glyphosate DAR, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf).
91. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
92. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 42–44 of the pdf.
93. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 44 of the pdf.
94. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 16–17 of the pdf.
95. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: pp. 42–44 of the pdf.
96. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 43 of the pdf.
97. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 42 of the pdf.
98. Rapporteur member state, Germany. 1998. Monograph on Glyphosate. Annex B–5.10.2: Toxicology and Metabolism. In: Glyphosate DAR, released by German government agency BVL on CD, Volume 3-1_Glyphosat_05.pdf: p. 42 of the pdf.
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156. vom Saal, F. S. and Hughes, C. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113: 926–933.
157. Myers, J. P., vom Saal, F. S. et al. 2009. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: The case of bisphenol A. Environmental Health Perspectives 117: 309–315
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Re: Roundup and birth defects: Is the public being kept in t
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Appendix: Potential for reform in pesticide use
A new EU regulation (2009/128) on the sustainable use of pesticides358 has the potential to bring positive reforms to pesticide practices in the EU. EU member states will have to come up with a National Action Plan aimed at reducing “risks and impacts of pesticide use on human health and the environment and at encouraging the development and introduction of integrated pest management and of alternative approaches or techniques in order to reduce dependency on the use of pesticides”. Among other measures, member states will have to:
●●Set up programmes to monitor the effects of pesticide spraying on the health of exposed groups of people
●●Minimize the use of pesticides in parks, school grounds, and public areas
●●Require sellers of pesticides (including retailers who sell to the public) to provide buyers with information about the risks of the pesticide, as well as information on less toxic alternatives
●●Require pesticide users to progressively reduce dependence on pesticides and to favour less toxic methods of weed and pest management.
The new regulation allows member states to set up systems to inform local people before pesticide spraying takes place, but this provision is voluntary. We argue that it should be mandatory and should order disclosure of the names of substances sprayed and the names and contact details of the parties who commission and carry out the spraying. Pesticide applicators must no longer be allowed to hide such information based on claims of commercial confidentiality.
While the new regulation contains many positive developments, much depends on how it is implemented. For example, even the old pesticide law has strict wording stipulating that a pesticide can only be approved if it has “no harmful effect on human or animal health or on groundwater” when correctly used, but this has never been properly implemented.359
A new EU regulation (2009/128) on the sustainable use of pesticides358 has the potential to bring positive reforms to pesticide practices in the EU. EU member states will have to come up with a National Action Plan aimed at reducing “risks and impacts of pesticide use on human health and the environment and at encouraging the development and introduction of integrated pest management and of alternative approaches or techniques in order to reduce dependency on the use of pesticides”. Among other measures, member states will have to:
●●Set up programmes to monitor the effects of pesticide spraying on the health of exposed groups of people
●●Minimize the use of pesticides in parks, school grounds, and public areas
●●Require sellers of pesticides (including retailers who sell to the public) to provide buyers with information about the risks of the pesticide, as well as information on less toxic alternatives
●●Require pesticide users to progressively reduce dependence on pesticides and to favour less toxic methods of weed and pest management.
The new regulation allows member states to set up systems to inform local people before pesticide spraying takes place, but this provision is voluntary. We argue that it should be mandatory and should order disclosure of the names of substances sprayed and the names and contact details of the parties who commission and carry out the spraying. Pesticide applicators must no longer be allowed to hide such information based on claims of commercial confidentiality.
While the new regulation contains many positive developments, much depends on how it is implemented. For example, even the old pesticide law has strict wording stipulating that a pesticide can only be approved if it has “no harmful effect on human or animal health or on groundwater” when correctly used, but this has never been properly implemented.359
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