Monsanto sues California environmental regulators to block glyphosate listing as carcinogen

Monsanto Co filed a lawsuit this week against California's Office of Environmental Health Hazard Assessment in attempt to block the agency's stated intent to list glyphosate as a possible human carcinogen.

The initial Reuters report is at this link.  

The website EcoWatch has another update on the case at this link.  

Monsanto's website has a PDF of the lawsuit filing which you can download and read as a PDF at this link.

The California agency hadn't responded publicly as of Friday, January 22. It's possible that several advocates for that listing will support the state of California. That could lead to a court case with expert witnesses on both sides, which could produce carefully documented epidemiological evidence from around the world. Usually, independent activist groups don't have the deep pockets to fund such cases. But they could provide California significant new data which complicates Monsanto's claims that glyphosate has proven safe for decades.

Monsanto's claim of 40 years of safety could be seriously eroded by a revelation from independent research scientist Anthony Samsel. He filed a Freedom of Information Act request for the entire file of Monsanto's registration applications with EPA — some 15,000 pages. He was given access with the stipulation that those proprietary documents couldn't be passed along to the public. But he's allowed to study and comment on them.

One key finding Samsel reports from these documents is that the only longer-term animal safety studies on "glyphosate" were done with the technical compound glyphosate itself — not the many variations of the glyphosate molecule linked with salts and other compounds which make glyphosate much more biologically active. Bluntly, the forms of glyphosate sold to customers and sprayed all over the globe are not the same form used in two-year toxicology tests on rats and mice. If Monsanto is force to argue in court that technical glyphosate, the bare molecule, is "substantially equivalent" to the complexed versions sold in the jug, they will probably be challenged with "Then why not sell exactly what you safety-tested?"

Anthony Samsel

In a message to us, Samsel points out:

"Just so we are all clear about what happened with the glyphosate approval process …
 
"Glyphosate salts and esters were tested and approved by the EPA, but there were no 2-year CHRONIC studies on these, including: Potassium glyphosate, sodium glyphosate, ammonium glyphosate and Isopropylamine glyphosate. However, only 90-day SUB-CHRONIC and acute toxicity studies were done on the salts and esters of glyphosate. 
 
"Instead of doing separate CHRONIC studies for each salt and ester, they used the CHRONIC long-term 2-year animal feeding studies from the technical acid, N-Phosphonomethyl glycine. They did a bait and switch. "Here is the EPA RED (Re-registration Eligibility Decision).  Contained within are the studies the EPA used to approve Isopropylamine glyphosate, sodium glyphosate, ammonium glyphosate etc. 
 
[Download the EPS's Re-registration Eligibility Decision as a PDF at this link.]
 
"LOOK ….. VERY CLOSELY at Section C: CHRONIC STUDIES.  These studies were from the GLYPHOSATE Technical Acid approval.  They were for N-Phosphonomethyl glycine and not the salts and esters.  This is a bait and switch."
 
 
In another memo to a website publisher, Samsel describes the "approval" process in more detail. In this memo he's referring to the European Union regulators as well as the American ones at EPA.
 
"Subject: GLYPHOSATE approval process a sham 
 
"I find it most interesting that so many involved in the regulatory process for the re-evaluation of Glyphosate will not to show their face or disclose their identity. I believe all persons involved in these decisions should be held accountable and their names made known for the sake of open and honest scientific debate. I would be happy to debate any one of them. I do not mean to be insulting, but the entire Glyphosate safety study process that led to the approval and marketing of Glyphosate-based herbicides, was a sham. Why do I say this ???
 
"Because if you look closely, you will see that all of the long-term studies were directed with intention of investigating Glyphosate the parent acid. However, all Glyphosate products are formulated with salts and or esters of Glyphosate.
 
"These Glyphosate products behave far differently in biology than the parent acid Glyphosate, which has low solubility, although still AMPHIPHILIC. The EPA is complicit in this charade and misrepresentation which is tantamount to a cheap magic parlor trick, a bait and switch if you will.
 
"In all of the over 15,000 pages of Monsanto trade secret documents, in my possession I do not find any long-term studies devoted to the salts and esters of Glyphosate. These multiple, two-year studies in mice and rats, as well as rabbits, dogs and others were all conducted with the Technical form of Glyphosate, N-Phosponomethyl glycine.
 
"These were the studies that led to the approval of Glyphosate and its registration. These studies were not conducted with the actual principle ingredients which include salts and esters which behave differently. Seralini was on the right track with his long-term rat studies, but missed the mark. What he found actually has a different meaning in light of what we know about glyphosate.
 
"It's not the surfactants, it's the salts and esters. This is just one of many points where Seralini and Samsel differ on what is responsible for the causal effects of Glyphosate. While it is necessarily true that surfactants as well as fungicides and many other chemicals increase the penetration, delivery and synergy of the herbicide with respect to the plant and other living things, it is actually the salts and esters of Glyphosate that are responsible for the damage to biology stemming from its behavior in the universal solvent, water.
 
"Here, It is also a solubility issue as the parent acid Glyphosate is far less soluble than the salts and esters which are used in agriculture which directly affect public health and the environment. Hence this is the major reason why these Glyphosate products behave more aggressively in biology. It is resolved and well understood that the salts and esters are by far more effective than the chemical parent acid Glyphosate, even John Franz noted this in his text on the subject Glyphosate.
 
"These salts and esters are far more available due to their solubility, which is determined by the attached cations to the Glyphosate molecule. In the case of the actual marketed products, these are the salts and esters expressed as the potassium, ammonium and isopropyl Glyphosates."
 
 Anthony Samsel, Research Scientist / Consultant P.O. Box 131 Deerfield, NH 03037
 
Another aspect of EPA's safety registration is that there's no requirement to document long-term effects of its use on microbial creatures in the soil. Those studies were gradually done outside of EPA auspices when concerns arose about soil ecology changes. Researchers like Dr. Robert Kremer at the University of Missouri found that glyphosate applications over several years substantially changed the bacterial and fungal populations in soils. The result has been a much more complex challenge with fungal diseases.
 
The World Health Organization included several glyphosate safety studies which EPA and the European Union discarded as irrelevant. An excellent glimpse into that approach shows up in Volker Barth's documentary film, Poisoned Fields, which we reported in an earlier article on this site. 
 
Monsanto's 2-year studies on rats fed "pure" glyphosate showed little health consequences, and that's the study given to EPA. When a French research team headed by Prof. Giles Sérilini ran a similar study, feeding the same type of rats with actual Roundup as sold to the public , many tumors and other damage showed up.
 
There's a wide array of research results on the Séralini website at this link.
 
A state agency such as California's Office of Environmental Health Hazard Assessment would be free to take the Séralini team's clinical trials into consideration.  They may also feel free to look at public health responses to glyphosate use around the world, such as Sri Lanka and Argentina where the statistical evidence of health impacts are emerging.
 
And, it's possible that California regulators would ask glyphosate manufacturers to defend bold, broad safety statements like this one, made in a Monsanto document "Agronomic Benefits of Glyphosate in Europe."  It says on page 4 that glyphosate is:
 

“Highly safe to operators, public and environment: glyphosate is only active in plants, acting by blocking the production of aromatic amino acids, a process that does not occur in animals. Modern glyphosate formulations contain adjuvants chosen for safety as well as performance reducing human or environmental impact and enabling use of lower use rates.”

The statement that glyphosate is only active in plants somehow slipped past the Monsanto scientists who know that glyphosate formulations are effective bactericides, which have major impacts on bacterial populations in the soil and in our digestive systems.