It was announced this morning that most of the toxicology section of the German draft renewal assessment report (RAR) on glyphosate was actually written by a consortium of chemical and biotechnology companies. Germany is the rapporteur member state (RMS) responsible for the safety review on glyphosate. The RMS submits the RAR to the European Food Safety Authority (EFSA) with a recommendation on whether or not to renew registration for glyphosate use in the EU. The German Federal Institute for Risk Assessment (BfR-- Bundesinstitut für Risikobewertung) is responsible for advising EFSA on glyphosate.
In typical bureaucratic fashion, the RAR report is massive and practically impenetrable. It consists of 15 documents and a total of 3,744 pages. It was only available on the EFSA website from January-May, during the comment period. It is unclear which department or committee at the BfR is responsible for this report. The BfR did not respond to multiple queries about authorship.
However, in the toxicology portion of the report, it clearly states: “Due to the large number of submitted toxicological studies, the RMS was not able to report the original studies in detail and an alternative approach was taken instead. The study descriptions and assessments as provided by the GTF were amended by deletion of redundant parts (such as the so-called “executive summaries”) and new enumeration of tables. Obvious errors were corrected. Each new study was commented by the RMS. These remarks are clearly distinguished from the original submission by a caption, are always written in italics and may be found on the bottom of the individual study summaries” [RAR, Vol. 3 Annex B.6.1., p. 5 and subsequent sections]. Very little of the report is in italics.
What is the GTF?
It is the Glyphosate Task Force, a consortium of chemical and biotechnology companies in Europe. These companies, headed by Monsanto Europe, prepared the dossier that was submitted to the BfR requesting the re-approval of glyphosate. The toxicology section consists, almost in its entirety, of the word-for-word assessment submitted by the GTF.
How safe is "safe"?
The document itself lists summaries of over a hundred unpublished, industry-sponsored studies where the toxic effects of glyphosate were evaluated. Glyphosate was administered in various ways (food, skin, inhalation etc.) to laboratory animals (mice, rats, rabbits, guinea pigs, dogs and chickens) at varying doses. Toxic adverse effects were always observed at some dosage. They assumed the response to the dose is linear, which is often not the case; and certainly not the case for endocrine disruptors. They then took the highest dose at which no adverse effects were observed, divided that by 100 and called it safe.
This would be believable if a person only ingested one dose at the “safe” level. But we are ingesting it every day in our food. This illusion of safety is based on their claims that glyphosate is quickly eliminated from the body, is not metabolized and does not accumulate in the body. This is false.
One study in rats has shown that 35-45% of ingested glyphosate is absorbed and traces of a metabolite, aminomethyl phosphonic acid (AMPA), were detected in the intestines and colon after a single dose. Seven days after ingestion, the total body burden was approximately 1% of the administered dose and was primarily associated with the bone. The authors reported AMPA to be a product of metabolic activity of intestinal microbes. In another study, both glyphosate and AMPA were detected in blood samples after ingestion. But these studies were ignored. Last March, Monika Kruger published data showing that glyphosate levels measured in the urine, kidney, liver, lung, spleen, intestines and muscle tissue of dairy cows were not significantly different, indicating that glyphosate does accumulate in body organs and tissue following a steady diet containing glyphosate residues. What happens after eating it daily in our food for 20 years?
The current “safe” rate for ingesting glyphosate in Europe is 0.3 milligrams per kilogram of body weight per day (mg/kg bw/day). The RMS recommended increasing that to 0.5 mg/kg bw/day. In the US, the “safe” rate is 1.75 mg/kg bw/day. They are telling us that it is okay for Europeans to consume 0.5 mg/kg bw/day for life. Apparently, its okay for us to consume 3.5 times that amount!
They tell us that these industry reports “prove” that glyphosate is non-toxic. What they really mean is that they believe that glyphosate ingested at this “safe” rate is non-toxic. They know that glyphosate causes intestinal problems, kidney problems, liver problems, reproductive problems, birth defects and cancer (among other things) at some dosage. Their own toxicology tests reveal that.
Categorizing and sorting data
Having established, from these industry-sponsored studies, that glyphosate is non-toxic, they then tackled the peer-reviewed publications. All studies that were in agreement with their already established conclusions were accepted. All studies that showed glyphosate or Roundup produced toxic effects were ranked using a special system and deemed “Not Reliable” for various reasons.
First, virtually all studies using an actual product were discounted because they are only reviewing glyphosate and not the various formulations (i.e. Roundup, Lasso, Rodeo etc.). Studies of an actual product containing glyphosate were considered “of limited value” for this reassessment even though, “taken as a whole, the published data suggest a higher toxicity of certain formulations as compared to glyphosate itself” [Vol. 1, p. 38].
Any in vitro tests using a formulation of glyphosate (Roundup) were discounted because, “cytoxic membrane disruption potential of surfactants are well known for in vitro test systems.” That is, they already know that the surfactants in Roundup (and other pesticides) break down the cell wall. But they're not interested in that aspect.
Other in vitro tests were discounted because they claimed these tests aren't relevant to mammals (frog embryos or insect larvae, for example) or the delivery method was not plausible in the real world (injection) or the dosage was unrealistically high. Pure glyphosate isn't used in the real world either, but that issue isn't addressed.
In vivo tests were discounted because there weren't enough rats used, or they were the wrong kind of rat or they took issue with how things were or were not measured or the doses were unrealistically high. They already know that high doses cause whatever problems were observed!
Actual human studies of people living in agricultural areas were discounted because there was no way to know what the actual exposure to glyphosate was, there was no proof that glyphosate was the cause (they might have been exposed to other toxic substances), the actual product was used and not glyphosate alone, the application rate (in South America) in the study is not relevant to Europe, “reporting deficiencies” and so on.
Safety in the US?
You might be thinking that everything is copacetic here in the US of A. Think again. US Environmental Protection Agency (EPA) staffer Evaggelos Vallianatos just published a book called Poison Spring (Bloomsbury, 2014). Vallianatos quotes the EPA scientist Adrian Gross as saying that EPA scientists don't actually read the studies they get from the chemical companies, but it's a “cut-and-paste business.” According to Vallianatos, “Staff scientists were openly using industry's own in-house (and therefore inherently biased) science in the formal approval process of dangerous chemicals. This was not oversight, it was rubber-stamping” [p. 123]. Chapter 7 gives a hair-raising account of how data is fabricated and falsified in these industry studies. According to Gross, such studies are unreliable “because EPA toxicologists don't really review them. ... Instead, they go straight to the company's summary and lift it word for word and give it as their own evaluation of those studies” [p. 130].
That's certainly what happened in the BfR report. Except they were so blatant that they didn't even bother to cut and paste. They just took the industry dossier and added comments to it. Perhaps the Europeans learned their methods from the EPA. The RAR makes mention of a Joint Glyphosate Task Force, LLC here in the US as being the owner of some of the data. Unlike the GTF in Europe, the JGTF doesn't advertise itself with a website. One might assume that the JGTF submitted the dossier to the EPA for glyphosate approval in the US. And the EPA scientists got busy cutting and pasting. Or merely commenting.
Oh, Europe, we thought better of you! With your mandatory labeling of GMOs and your caution in approving them, we thought you were leading the way. We hoped you would set an example, rather than follow our bad example.
A detailed synopsis of the toxicology section of the RAR can be found here.