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Roundup, Monsanto's Scientific Fraud

Roundup, Monsanto's Scientific Fraud

As indicated below, Fraud in testing is the norm, and that there is no regulatory oversight—not in the last 2 decades in our corporatist state.  Monsanto submits its research without review of the raw data.  Independent research shows (counter to Monsanto release and advertising) that Roundup is not safe nor is it quickly broken down in the environment.  Worth watching is “The World According to Monsanto” a 2008 documentary (also available in a 2012 paperback)--jk. 

From Wikipedia:  http://en.wikipedia.org/wiki/Roundup_%28herbicide%29#Toxicity

Roundup is the brand name of a systemic, broad-spectrum herbicide produced by the U.S. company Monsanto, and contains the active ingredient glyphosate. Glyphosate is the most widely used herbicide in the USA,[2] and Roundup has been the number one selling herbicide worldwide since at least 1980.[3] As of 2009, sales of Roundup herbicides represent about 10% of Monsanto's revenue due to competition from Chinese producers of other glyphosate-based herbicides;[4] the overall Roundup line of products (which includes GM seeds) represents about half of Monsanto's yearly revenue.[5]

Monsanto developed and patented the glyphosate molecule in the 1970s, and marketed Roundup from 1973. It retained exclusive rights in the US until its US patent expired in September, 2000, and maintained a predominant marketshare in countries where the patent expired earlier.

The main active ingredient of Roundup is the isopropylamine salt of glyphosate. Another important ingredient of Roundup is the surfactant POEA (polyethoxylated tallow amine), which is known for its toxicity in wildlife.[6] It increases herbicide penetration in plant[7] and animal[8][9] cells.

Monsanto also produces seeds which grow into plants genetically engineered to be tolerant to glyphosate, which are known as Roundup Ready crops. The genes contained in these seeds are patented. Such crops allow farmers to use glyphosate as a post-emergence herbicide against most broadleaf and cereal weeds. Soy was the first Roundup Ready crop, and was produced at Monsanto's Agracetus Campus located in Middleton, Wisconsin

Scientific fraud

On two occasions, the United States Environmental Protection Agency has caught scientists deliberately falsifying test results at research laboratories hired by Monsanto to study glyphosate.[57][58][59] In the first incident involving Industrial Biotest Laboratories, an EPA reviewer stated after finding "routine falsification of data" that it was "hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits".[60][61][62] In the second incident of falsifying test results in 1991, the owner of Craven Laboratories and three employees were indicted on 20 felony counts, the owner was sentenced to 5 years in prison and fined $50,000, the lab was fined 15.5 million dollars and ordered to pay 3.7 million dollars in restitution.[43][63][64] Craven Laboratories performed studies for 262 pesticide companies including Monsanto.  {For 2-decades with a ruling from the FDA that the modified crops do not contain drugs, there is no regulatory safety review.  There is still oversight in Europe—jk.}

Monsanto has stated that the studies have been repeated, and that Roundup's EPA certification does not now use any studies from Craven Labs or IBT. Monsanto also said that the Craven Labs investigation was started by the EPA after a pesticide industry task force discovered irregularities.[65]

Difference between regulatory registered and commercialized formulations

In November 2009, a French environment group (MDRGF) accused Monsanto of using chemicals in Roundup formulations not disclosed to the country's regulatory bodies, and demanded the removal of those products from the market.[66][67]

False advertising

In 1996, Monsanto was accused of false and misleading advertising of glyphosate products, prompting a law suit by the New York State attorney general.[53] Monsanto had made claims that its spray-on glyphosate based herbicides, including Roundup, were safer than table salt and "practically non-toxic" to mammals, birds, and fish.[54]

Environmental and consumer rights campaigners brought a case in France in 2001 for presenting Roundup as biodegradable and claiming that it left the soil clean after use; glyphosate, Roundup's main ingredient, is classed by the European Union as "dangerous for the environment" and "toxic for aquatic organisms". In January 2007, Monsanto was convicted of false advertising.[55] The result was confirmed in 2009.[56]

Toxicity

A 2009 study has concluded that while physiological pH decreases glyphosate uptake in animal cells, Roundup formulation contains surfactants that increase membrane permeability allowing cellular uptake at physiological pH.[8] 

 

Aquatic effects

Fish and aquatic invertebrates are more sensitive to Roundup than terrestrial organisms.[34] Glyphosate is generally less persistent in water than in soil, with 12 to 60 day persistence observed in Canadian pond water, yet persistence of over a year have been observed in the sediments of ponds in Michigan and Oregon.[12]
The EU classifies Roundup as R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.[35]

Although Roundup is not registered for aquatic uses[36] and studies of its effects on amphibians indicate it is toxic to them,[37] scientists have found that it may wind up in small wetlands where tadpoles live, due to inadvertent spraying during its application. A recent study found that even at concentrations one-third of the maximum concentrations expected in nature, Roundup still killed up to 71 percent of tadpoles raised in outdoor tanks.[38]

A 2010 study has found that long-term exposition to environmental relevant concentrations of a Roundup formulation causes metabolic disruption in the fish leporinus obtusidens.[39]

Toxicity

Laboratory studies have shown teratogenic effects of Roundup in animals.[14][15] These reports have proposed that the teratogenic effects are caused by impaired retinoic acid signaling.[16] News reports have supposed that regulators have been aware of these studies since 1980.[17] The United States Environmental Protection Agency (EPA) considers glyphosate to be relatively low in toxicity, and without carcinogenic or teratagenic effects.[18] The EPA considered a "worst case" dietary risk model of an individual eating a lifetime of food entirely from glyphosate-sprayed fields, and with residue levels remaining at their maximum levels, and concluded no adverse effects would exist under these conditions.[18]

A 2000 review concluded that "under present and expected conditions of new use, there is no potential for Roundup herbicide to pose a health risk to humans".[19] The 2000 review has been criticized because it reviewed mostly experiments in which glyphosate and POEA were used alone, not as a mixture as in Roundup, and for only one or two years.[20] They did not review toxicity studies of Roundup treatments (as a mixture) in rats or rabbits lasting more than 22 days[20] and Roundup's potential as an endocrine disruptor was not assessed with a Roundup mixture at all.[20]

A 2008 scientific study has shown that Roundup formulations and metabolic products cause the death of human embryonic, placental, and umbilical cells in vitro, even at low concentrations. The effects were not proportional to the main active ingredient concentrations (glyphosate), but dependent on the nature of the adjuvants used in the Roundup formulation.[21]

Deliberate ingestion of Roundup herbicide in quantities ranging from 85 to 200 ml has resulted in death within hours of ingestion, although it has also been ingested in quantities as large as 500 ml with only mild or moderate symptoms following ingestion.[22] There is a reasonable correlation between the amount of Roundup ingested and the likelihood of serious systemic sequelae or death. Ingestion of >85 mL of the concentrated formulation is likely to cause significant toxicity in adults. Gastrointestinal corrosive effects, with mouth, throat and epigastric pain and dysphagia are common. Renal and hepatic impairment are also frequent and usually reflect reduced organ perfusion. Respiratory distress, impaired consciousness, pulmonary oedema, infiltration on chest x-ray, shock, arrythmias, renal failure requiring haemodialysis, metabolic acidosis and hyperkalaemia may occur in severe cases. Bradycardia and ventricular arrhythmias often present prior to death. Dermal exposure to ready-to-use glyphosate formulations can cause irritation, and photo-contact dermatitis has been reported occasionally; these effects are probably due to the preservative Proxel (benzisothiazolin-3-one).Inhalation is a minor route of exposure, but spray mist may cause oral or nasal discomfort, an unpleasant taste in the mouth, tingling and throat irritation. Eye exposure may lead to mild conjunctivitis, and superficial corneal injury is possible if irrigation is delayed or inadequate.[13]

Glyphosate is toxic to human skin cells, through causing oxidative damage; antioxidants such as Vitamin C and E were found to provide some protection to such damage, leading the authors of the study to recommend that these chemicals be added to formulations including glyphosate.[23] Severe skin burns are very rare.[13]

 

Endocrine disruptor

A 2000 in vitro study on mouse MA-10 cells concluded that Roundup inhibited progesterone production by disrupting StAR protein expression.[24] Further studies demonstrated this was not caused by glyphosate but to surfactants used as inactive ingredients in Roundup formulations.[25]

A 2005 in vitro study on human placental JEG3 cells concluded that the glyphosate disruption of aromatase is facilitated by adjuvants of the Roundup formulation.[9][26]

A 2009 in vitro experiment with glyphosate formulations on human liver HepG2 cells has observed endocrine disruption at sub-agricultural doses, where a Roundup formulation showed to be the most active formulation. The effects were more dependent on the formulation than on the glyphosate concentration.[27]

A 2009 study on rats has found that Roundup is a potent endocrine disruptor causing disturbances in the reproductive development when the exposure was performed during the puberty period.[28]

Roundup has been found to interfere with an enzyme involved in testosterone production in mouse cell culture[29] and to interfere with an estrogen biosynthesis enzyme in cultures of Human Placental cells.[30]

 

Genetic damage

A 1998 study on mice concluded that Roundup is able to cause genetic damage. The authors concluded that the damage was "not related to the active ingredient, but to another component of the herbicide mixture".[31]

A 2005 study raised concerns over the effects of Roundup in transcription.[32]

A 2009 study on mice has found that a single intraperitoneal injection of Roundup in concentration of 25 mg/kg caused chromosomal aberrations and induction of micronuclei.[33]

A 2009 in vitro experiment with glyphosate formulations on human liver cells has observed DNA damages at sub-agricultural doses, where a Roundup formulation showed to be the most active formulation. The effects were more dependent on the formulation than on the glyphosate concentration.[27]

 

 

 

 

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It is worse than these headlines, since now in the U.S. genetically modified crops are excluded from regulatory review.  For more on issues, http://www.gmfreecymru.org/news.htm

http://www.gmfreecymru.org/documents/fraud_roundup.htm

The Monsanto files: fraud in Roundup / Glyphosate testing

A reminder (if any is needed) that companies working for Monsanto have in the past delivered the results Monsanto wanted, even if the evidence pointed somewhere else....... note the wonderful remark about uterus samples being taken from male rabbits!

http://www.1hope.org/glyphos8.htm

Journal of Pesticide Reform, Volume 15, Number 3, Fall 1995. Northwest Coalition for Alternatives to Pesticides, Eugene, OR. Glyphosate, Part 1: Toxicology, by Caroline Cox

Extract:

Tests done on glyphosate to meet registration requirements have been associated with fraudulent practices.

Laboratory fraud first made headlines in 1983 when EPA publicly announced that a 1976 audit had discovered "serious deficiencies and improprieties" in toxicology studies conducted by Industrial Biotest Laboratories (IBT).44 Problems included "countless deaths of rats and mice that were not reported," "fabricated data tables," and "routine falsification of data."44

IBT was one of the largest laboratories performing tests in support of pesticide registrations.44 About 30 tests on glyphosate and glyphosate-containing products were performed by IBT, including 11 of the 19 chronic toxicology studies.45 A compelling example of the poor quality of IBT data comes from an EPA toxicologist who wrote, "It is also somewhat difficult not to doubt the scientific integrity of a study when the IBT stated that it took specimens from the uteri (of male rabbits) for histopathological examination."46 (Emphasis added.)

In 1991, laboratory fraud returned to the headlines when EPA alleged that Craven Laboratories, a company that performed contract studies for 262 pesticide companies including Monsanto, had falsified test results.47 "Tricks" employed by Craven Labs included "falsifying laboratory notebook entries" and "manually manipulating scientific equipment to produce false reports."48 Roundup residue studies on plums, potatoes, grapes, and sugarbeets were among the tests in question.49

The following year, the owner/president of Craven Laboratories and three employees were indicted on 20 felony counts. A number of other employees agreed to plead guilty on a number of related charges.50 The owner was sentenced to five years in prison and fined $50,000; Craven Labs was fined 15.5 million dollars, and ordered to pay 3.7 million dollars in restitution.48

Although the tests of glyphosate identified as fraudulent have been replaced, these practices cast shadows on the entire pesticide registration process.

References (relevant to the above extract)

44. U.S. Congress. House of Representatives. Committee on Government Operations. 1984. Problems plague the Environmental Protection Agency's pesticide registration activities. House Report 98-1147. Washington, D.C.: U.S. Government Printing Office.

45. U.S. EPA. Office of Pesticides and Toxic Substances. 1983. Summary of the IBT review program. Washington, D.C. (July.)

46. U.S. EPA. 1978. Data validation. Memo from K. Locke, Toxicology Branch, to R. Taylor, Registration Branch. Washington, D.C. (August 9.)

47. U.S. EPA. Communications and Public Affairs. 1991. Note to correspondents. Washington, D.C. (March 1.)

48. U.S. EPA. Communications, Education, And Public Affairs. 1994. Press advisory. Craven Laboratories, owner, and 14 employees sentenced for falsifying pesticide tests. Washington, D.C. (March 4.)

49. U.S. EPA. Communications and Public Affairs. 1991. Press advisory. EPA lists crops associated with pesticides for which residue and environmental fate studies were allegedly manipulated. Washington, D.C. (March 29.)

50. U.S. Dept. of Justice. United States Attorney. Western District of Texas. 1992. Texas laboratory, its president, 3 employees indicted on 20 felony counts in connection with pesticide testing. Austin, TX. (September 29.)

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