Page Five

Monsanto Papers | Secret Documents | Page Five

Issue: Surfactants, Carcinogenicity & Testing

30. Monsanto Study: Lifetime Carcinogenicity Study in Mice
No: MONGLY04272196
Date: 12/26/1984
Documents Released: 3/15/2017

Description
This document contains a Monsanto-led study testing N-ntirosoglyphosate (“NNG”) on mice. Before getting a pass from the EPA, Monsanto conducted this one long-term carcinogenicity test of NNG in mice. The testing was conducted outside of IBT laboratories (which Monsanto had used for NNG testing until it was shut down due to fraud). This study demonstrated a statistically significant increase in malignant lymphomas in male mice. No evidence suggests this study was ever submitted to EPA.

31. EPA Document Determining N-nitrosoglyphosate (“NNG”) Studies Not Acceptable
No: MONGLY01298420
Date: 6/1986
Documents Released: 3/15/2017

Description
This document contains an EPA paper entitled, ‘Guidance for the Reregistration of Pesticide Products Containing Glyphosate as the Active Ingredient’. The EPA initially required that Monsanto test for the carcinogencity of NNG in the 1970s and early 1980s. The testing for NNG by Monsanto was mainly conducted by IBT laboratories which was shut down in the 1970s due to fraud. The EPA determined that these NNG studies were not acceptable to show that NNG was not mutagenic. The EPA, however, did not require additional testing on NNG provided that Monsanto keep the levels of NNG below 1 ppm.

32. Email Exchange Shows Former Monsanto Expert Confirmed Biological Plausibility of Glyphosate as Carcinogen
No: MONGLY06486905
Date: 4/17/1999 – 4/19/1999
Documents Released: 8/1/2017

Description
This document contains email exchanges between various Monsanto personnel wherein Dr. Donna Farmer summarizes the findings of Monsanto’s expert, Dr. James Parry: “Dr. Parry concluded on his evaluation of the four articles that glyphosate is capable of producing genotoxicity both in vivo and in vitro by a mechanism based upon the production of oxidative damage.” at *3.

Relevance
The document is relevant and reasonably likely to be used in this litigation as it contains conclusions by a former Monsanto expert in support of the biological plausibility of glyphosate to cause cancer—namely through glyphosate’s genotoxic potential and its capacity to precipitate oxidative stress. This is also relevant to Dr. Farmer’s credibility, who is one of Monsanto’s primary expert witnesses at the company.

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33. Toxicologist Reluctant to Conduct Studies on Glyphosate, Roundup Formulations or Surfactant Ingredients Because Results Could Concern Monsanto
No: MONGLY00877683
Date: 7/29/1999 – 8/3/1999
Documents Released: 8/1/2017

Description
This document, from 1999, contains email correspondence from between various Monsanto personnel wherein Dr. Donna Farmer writes: “I will not support doing any studies on glyphosate, formulations or other surfactant ingredients at this time with the limited information we have on the situation.” at *2.

Relevance
This document is relevant and reasonably likely to be used in this litigation as it demonstrates reluctance by a key Monsanto toxicologist to conduct studies on either glyphosate, Roundup formulations, or surfactant ingredients, suggesting Monsanto was concerned with the results it would find. This is relevant to the issue of biological plausibility of Roundup and/or glyphosate as a carcinogen. Indeed, Monsanto maintains that it is not biologically plausible for Roundup or glyphosate to be carcinogenic, a central contention of the general causation litigation, but then expresses fear of conducting studies since it will show a cancer risk. This is also relevant to Dr. Farmer’s credibility, who is one of Monsanto’s primary expert witnesses at the company.

34. Dr. James Parry Glyphosate Review: ‘Evaluation of the potential genotoxicity of Glyphosate, Glyphosate mixtures and component surfactants” – 1999
No: MONGLY01314233 – MONGLY01314270
Date: 8/1999
Documents Released: 3/15/2017

Description
In 1999, Monsanto hired Dr. James M. Parry, professor at the University of Wales, to conduct an internal (and secret) safety review of glyphosate and the formulated product. In the beginning of the report, Dr. Parry identified as the first deficiency in the data: “No adequate in vitro clastogenicity data available for glyphosate formulations.” He, thus, recommends that Monsanto “provide comprehensive in vitro cytogenetic data on glyphosate formulations.” He also concludes, “My overall view is that if the reported genotoxicity of glyphosate and glyphosate formulations can be shown to be due to the production of oxidative damage then a case could be made that any genetic damage would be thesholded…it may be necessary to consider the possibility of susceptible groups within the human population.”

35. Monsanto Toxicologist Donna Farmer: Dr. Parry Left Monsanto in a “Genotox Hole”
No: MONGLY00878595 – MONGLY00878597
Date: 9/2/1999
Documents Released: 3/15/2017

Description
This document contains email correspondence between several Monsanto colleagues discussing the fallout from Dr. James Parry’s report on glyphosate (MONGLY01314233). Donna Farmer (Monsanto Toxicologist) writes: “right now the only person I think that can dig us out of this “genotox hole” is the Good Dr. Kier…I am concerned about leaving Perry [sp] out there with this as the final project/his final impressions…”

Stephen Wratten (Monsanto) asks whether Dr. Parry “ever worked with industry on this sort of project?” Later, Wratten intones that the Parry report is not useful for Monsanto: “I do not see that he has stuck his neck out on anything at all controversial, and therefore, there is little value in the write-up as written that could be useful. Hope it didn’t cost much…”

36. Email from William Heydens: Monsanto ‘Vulnerable’ on Gene Tox After Parry
No: MONGLY03734971
Date: 9/16/1999
Documents Released: 3/15/2017

Description
This document contains an email from William Heydens to Monsanto colleagues after reading the Parry report on glyphosate. In his correspondence, Heydens writes after reading the report: “We want to find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and who can be influential with regulators and Scientific Outreach operations when genetox issues arise. My read is that Parry is not currently such a person, and it would take quite some time and $$$/studies to get him there. We simply aren’t going to do the studies Parry suggests.

37. Internal Email Shows Monsanto Aware of Surfactant Toxic Effects
No: MONGLY00878828
Date: 3/8/2000 – 3/12/2000
Documents Released: 8/1/2017

Description
This document contains email correspondence between various Monsanto personnel wherein it is stated with respect to Roundup surfactants: “While the tallow amine was considered toxic at 62.5 and 15.6 ug/ml, the C12 alkyl sulfate didn’t exhibit toxicity at any of the test doses. While both of these compounds produced a marginal response which didn’t meet the test criteria for a robust positive, they did elicit an effect which was judged to be an equivocal, but test article-related effect.” at *5.

Relevance
This document is relevant and reasonably likely to be used in this litigation as it indicates that Monsanto was aware of the toxic effects of the tallow amine surfactant in the formulated Roundup product. This admission expressly contradicts Monsanto’s position that there is no biologically plausible basis for Roundup to be considered a carcinogen.

38. Monsanto Scientist Admits Potential for Data Coaching in Monsanto Glyphosate Exposure Study
No: MONGLY07080361
Date: 7/5/2000
Documents Released: 8/1/2017

Description
This document is a study “site visit” from July 7, 2000 of the “Farm Family Exposure” study. Dr. John Acquavella (Monsanto employee at the time) and John Cowell conduct the site visit. The report indicates numerous deficiencies with the study, including: “Protocol amendments had not yet been forwarded to the study team from Exponent; Many of the urines were very spotty and we found one day’s urine that was obviously doctored. As at the Minnesota field site, the field team is not reviewing the urines carefully and there is little, if any, coaching of the farm families; There were some obvious errors or missing entries in the questionnaires.” at *7-8.

Relevance
This document is relevant and reasonably likely to be used in this litigation as it outlines significant deficiencies—including use of potentially doctored or “coached” data—with a study evaluating glyphosate exposure and the biological plausibility of glyphosate as a carcinogen. This goes to the credibility and reliability of the study, which is relied upon extensively by Monsanto to mount its general causation defense.

39. Monsanto Internal Email: Employee Expresses ‘Serious Concern’ Over Plausibility of Roundup Formulation Carcinogenicity
No: MONGLY00923065
Date: 2/12/2001 – 2/13/2001
Documents Released: 8/1/2017

Description
This document contains email correspondence between various Monsanto personnel wherein Dr. Mark Martens states: “I don’t know for sure how suppliers would react – but if somebody came to me and said they wanted to test Roundup I know how I would react – with serious concern. We have to really think about doing formulations even if they are not on the market . . . glyphosate is still in there and could get caught up in some false positive finding. at *1.

Relevance
This document is relevant and reasonably likely to be used in this litigation as it contains explicit concerns by Monsanto regarding the biological plausibility of the formulated product to cause cancer.

40. Monsanto Finds Levels of N-nitrosoglyphosate (NNG) Exceed the Limit of 1 ppm
No: MONGLY04683604
Date: 2/20/2001
Documents Released: 3/15/2017

Description
This document contains email correspondence between Eric Haupfear (Monsanto Director of Process Technology) and others in monitoring NNG levels of glyphosate. In 2000, Haupfear found that the levels of NNG exceeded the limit of 1 ppm due to a manufacturing defect.

“Concentration of NNG in Glyphosate: (0.0000143 / 10.24) = 1.4 ppm!!”

41. Email Exchange Responding to Dr. James Parry’s Request to Test Propachlor (Monsanto Herbicide)
No: MONGLY00905534
Date: 4/10/2001
Documents Released: 3/15/2017

Description
In this document, Monsanto executive William Heydens expresses concern over Dr. James Parry’s request to evaluate Propachlor, an herbicide that Monsanto holds the patent to. Mark Martens writes that one of the advantages of letting Parry test Propachlor is that will “keep prof Parry happy which will make him a good proponent of glyphosate.”

Heydens disagrees: “Please don’t do anything until we discuss this. Data generated by academics has always been a major concern for us in the defense of our products.”

42. Donna Farmer: Mark Martens’ Work with Dr. James Parry “Almost Landed Us with Parry Calling Glyphosate Genotoxic”
No: MONGLY00891769
Date: 9/10/2001
Documents Released: 3/15/2017

Description
The document contains email correspondence between Donna Farmer (Monsanto Toxicologist) and Daniel Goldsten. Farmer includes a previous correspondence in which William (Bill) Graham tells colleagues: “One of the problems with email – everyone can start running around looking for solutions. Can we keep this to a limited number of people as we have the opinions and the solutions in Europe.”

The email also references Mark Martens’ work with Dr. James Parry, a highly respected expert in genotoxicity. According to Farmer: “Mark was not managing that well and that almost landed us with Parry calling glyphosate genotoxic….so we had to do these additional studies to make him happy and if it had not been for Larry Kier we would be in dog…….”

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