Reality-Check
June 8, 2015
Our response to today’s Der Spiegel article on glyphosate // Unsere Antwort auf dem heutigen Artikel im Spiegel zum Thema Glyphosat

By Brandon Mitchener

On June 8, 2015, Der Spiegel, a leading German news magazine, published a long article that rehashes many of the anti-pesticide activists’ most frequent questions and allegations concerning glyphosate, a key ingredient in popular weed killers including Monsanto’s Roundup®. Many of the arguments cited in the article have already been the subject of other, individual responses on this blog, and by other organisations.

We were initially delighted that Der Spiegel reached out to us with questions that appeared to represent an exercise in fact-checking before publishing its article. All too often, we are confronted by media reports from journalists who either didn’t bother to contact us at all, or claimed that we couldn’t be reached, although we can find no trace that they’d ever called. It was therefore doubly disappointing to see an article that clearly has been hijacked by an activist agenda and ignores the substantial evidence that its indignant tone is misplaced.

Despite keeping a team of Monsanto scientists and public relations people busy for a week researching nine detailed answers to very specific, detailed questions, the reporter, Philip Bethge, chose not to quote from any of our detailed responses at all, only from a public statement on our website.

Integrity, dialogue and transparency are three key elements of Monsanto’s public commitments in the form of the Monsanto Pledge, which governs our interactions with society. This blog is one manifestation of that commitment. The Reality-Check page is devoted to debunking the many myths that circulate about Monsanto, responding to shoddy journalism and demonstrating integrity, dialogue and transparency when journalists deprive us of that opportunity.

In that light, we have decided to publish our correspondence with Der Spiegel (below) so that the readers of both this blog and Der Spiegel can decide for themselves whether their trust in the magazine’s news judgement is well placed. The correspondence below is organized like an e-mail thread, in reverse chronological order, with the newest exchange at the top. We have added emphasis throughout to make it easier for people to find the information that Der Spiegel didn’t consider worth including in its story.

July 17, 2017 update:  In addition to the exchange and comments below, we Der Spiegel a more detailed response by registered mail delivered on July 8. To-date we have received no response from the magazine. In the interest of transparency, and informing the readers of Der Spiegel of our reaction to the article in question, we publish our response here in its entirety.

—-

[Email of June 3, 2015]

Dear Mr. Bethge,

Thank you for the extra time to research the answers to your questions. The answers to questions 3, 4 and 5 are detailed in the attached Word document. If you are short on time and mainly looking for quotes, I’d suggest looking first at the sections that I’ve highlighted.

To your follow-up question about the lifetime rat studies, we also conducted several 2-year studies ourselves (according to international testing protocols, unlike the study that you referenced), and the results of those tests were part of our submission to the BfR and can be found in the section beginning on page 443 of the BfR’s Renewal Assessment Report to the European Commission, which can be found on EFSA’s website.

Best regards,

Brandon

(3) Has Monsanto ever conducted feeding studies with rats or other mammals using Roundup-formulations as a percentage of the feed (not Glyphosate alone)? If yes, please provide the paper and answer the following questions:

How many rats were used for the experiments? How long were the rats fed with Roundup? Which were the results?

(4) Which were the longest toxicological tests performed in mammals, including blood analysis, to prove that Roundup or other Glyphosate-formulations are safe? Which was the lowest dose at which Roundup was tested? Which were the results?

(5) In case there are no such tests: Why not?

Bundled response

Globally there are legal data requirements that are conditional to registering active substances and plant protection products in Europe. They are stipulated in regulations (EU Regulations 283/2013 and Regulation 284/2013 respectively). These Regulations are binding.

The toxicology data requirements for plant protection products (Roundup® branded formulations for instance) consist of a series of six studies that assess the acute toxicity, irritation and sensitization profile of the product:

The methods (protocol prescriptions) for conducting these studies are methods established with international consensus (OECD). The number of animals to be used is clearly outlined as part of the methods.

In the acute oral toxicity studies (the only required ‘feeding’ study for plant protection products), 5 animals per sex will be used for each dose level under investigation. For Roundup®-branded formulations typically a limit dose is used that corresponds to the threshold for classification for acute toxicity. By testing at the top of the recommended testing range we limit the number of animals that are sacrificed.

For Roundup Ultra (the lead formulation in the glyphosate re-registration dossier) we tested 5 male and 5 female rats at the limit dose of 5000 mg/kg. No mortalities were observed which results in an LD50 (a testing dose leading to 50% mortality) that is (significantly) higher than 5000 mg/kg:  LD50-oral> 5000 mg/kg

Results for the other required acute tests were as follows:

LD50-dermal> 5000 mg/kg ; Non-irritant for skin; Non-irritant for eye; Non-sensitizing

The study summaries for these tests and the evaluation of the German BfR are available in the renewal assessment report for glyphosate that can be found on the EFSA website (p 841-867 Volume 3- B6).

Regulation 284/2013 does not require plant protection products to be tested in longer-term toxicity studies. This is because of the regulators base their evaluations on the realistic long term exposure scenarios (mainly to active ingredient), the extremely well-documented, long-term toxicology profile of the active ingredients and the acute toxicity, irritation and sensitization profile of a formulated product.

However it should be noted that based on Monsanto’s product stewardship programmes extensive toxicology studies including sub-chronic and longer-term studies with the polyethoxylated tallowamine (POET) surfactant have been conducted. With this additional information and the well-documented toxicological profile of glyphosate the regulators have made their safety evaluation of human exposure to the Roundup®-branded formulation.

The study summaries for the toxicology tests with POET and the evaluations of those studies by the German BfR are available in the renewal assessment report for glyphosate on the EFSA website (p870-884 Volume 3 B6).:

It should be noted that the German authorities conclude that the available data on this surfactant is sufficient to support the assumption that critical effects of glyphosate-based plant protection products that were not seen with the active ingredient were due to the toxicity of the POET surfactant alone. It is therefore reasonable to conclude that it is not necessary to conduct such long-term toxicity tests with the formulated product itself.

Please note that there are very clear provisions in the pesticide regulation (Regulation 1107/2009 Article 62) and the regulations outlining the data requirements for active substances (Regulation 283/2013 – Annex point 5) and plant protection products (regulation 283/2013 – Annex point 5) to minimize vertebrate testing. Studies that are not strictly required are not essential or can be avoided in the context of hazard identification or risk assessment should be avoided and will not be accepted by the regulating authorities. In this context all our commercial plant protection products in Europe have been evaluated according to the stringent EU regulations, meet all technical and safety requirements and have passed all relevant risk assessments. We follow all regulations and generate all required data to meet legal and regulatory requirements. These data requirements are not product-specific and are the same for all crop protection products.

Therefore it’s fair to say that glyphosate has been tested following the state-of-the-art procedures (in the EU and globally) for testing the safety of plant protection products. It is on that basis that authorities in the EU and around the world have repeatedly approved our products.

Regarding the lowest dose levels

In long-term toxicology studies dose rates are selected in a way to adequately understand the dose response and to allow the setting of adequate endpoints. The range of the dose selection depends on the study type and expected outcome.

The lowest doses tested with the POET surfactant were 7 mg/kg bw/day and 6 mg/kg bw /day in the reproduction studies and 15 mg/kg bw/day in the developmental toxicity study. These dose levels were well below the no-observed-adverse effect levels of the study.

—-

From: [Philip Bethge]
Sent: Monday, June 01, 2015 5:41 PM
Subject: Re: Media Inquiry: Philip Bethge/DER SPIEGEL Mag/Glyphosate Roundup

Dear David Carpintero, dear Brandon Mitchener,

thank you very much for the information. There are no answers to questions 3 and 4. Please clarify. The questions are very specific. Answer to 5 doesn’t help. Please provide more details on the Roundup testing regime required by the regulatory authorities.

Specifically: Is the Seralini 2012 study the only lifetime study ever that tested Roundup formulations on rats? Is there any comparable study by Monsanto? If yes, which were the results?

Please answer before Wednesday 6 pm MET.

Thanks and best regards,

Philip Bethge

—-

[Email of June 1, 2015, 15:55]

Dear Dr. Bethge,

As discussed last Wednesday over the phone, you can find below the answers to your questions on glyphosate.

Please, do not hesitate to ask should you need further details.

Best regards,

David Carpintero and Brandon Mitchener

—–Original Message—–

From: [Monsanto]

Sent: Wednesday, May 20, 2015 2:31 AM

To: MEDIA, QUERIES [AG/1000]

Subject: Form submission from: Media Inquiry Request Form16.254]

Outlet: DER SPIEGEL news magazine

Country: Germany

Deadline Date: May 26, 2015

Deadline Time: 6:00 pm

Timezone: Eastern

General  Topic of Interest: Glyphosate/Roundup

Questions:

Dear Sir or Madam,

I am an editor with DER SPIEGEL, Germanys leading news magazine and the biggest in Europe.

I am looking into Glyphosate right now. Please be so kind to answer the following questions before Tuesday, May 26, in the evening.

(1) How does Monsanto comment on the IARC Classification for Glyphosate?

We have a public position in our corporate website: http://www.monsanto.com/iarc-roundup/pages/default.aspx

(2) How do you respond to allegations (summarized here http://www.gmfreecymru.org/documents/monsanto_knew_of_glyphosate.html) that Monsanto knew of a glyphosate-cancer link 35 years ago?

Regulatory authorities around the world have reviewed numerous long-term carcinogenicity studies and agree that there is no evidence that glyphosate causes cancer, even at very high doses.

Greim H., D. Saltmiras, V. Mostert and C. Strupp. (2015) Evaluation of carcinogenic potential of the herbicide glyphosate, drawing on tumor incidence data from fourteen chronic/carcinogenicity rodent studies. Critical Reviews in Toxicology 45 (3):185-208.

(3) Has Monsanto ever conducted feeding studies with rats or other mammals using Roundup-formulations as a percentage of the feed (not Glyphosate alone)? If yes, please provide the paper and answer the following questions:

How many rats were used for the experiments? How long were the rats fed with Roundup? Which were the results?

(4) Which were the longest toxicological tests performed in mammals, including blood analysis, to prove that Roundup or other Glyphosate-formulations are safe? Which was the lowest dose at which Roundup was tested? Which were the results?

(5) In case there are no such tests: Why not?

Our commercial products in Europe are evaluated according to stringent EU regulations, meet all technical and safety requirements and have passed all relevant risk assessments. We follow all regulations and generate all required data to meet legal and regulatory requirements. These data requirements are not product specific and are the same for all crop protection products. Therefore it’s fair to say that glyphosate has been tested following the state of the art procedures in the EU and globally for testing the safety of plant protection products. On that basis, authorities in the EU and around the world have confirmed safety and approved our products.

(6) Is Monsanto still using POE-Tallowamines as adjuvants in Roundup or other Glyphosate formulations? Which are the toxicological profiles of POE-Tallowamines? Have they been tested on mammals?

We are currently using different technologies than POE-Tallowamines in our formulations sold in Germany.

(7) Which other adjuvants is Monsanto using in Glyphosate formulations such as Roundup? Which are the toxicological profiles of these adjuvants? Have they been tested on mammals?

This is business confidential information that we do not share publicly for commercial reasons. We comply with the corresponding regulatory requirements. 

(8) Are there any Monsanto Glyphosate formulations on the German market that have POE-Tallowamines as adjuvants?

No, there are no currently Monsanto Glyphosate formulations with POE-Tallowamines as adjuvants sold in Germany.

Thank you very much in advance for your help.

Best regards,

Philip Bethge

 

Comments

    Philip Bethge
    |
    June 9, 2015
    [Email-Response by Philip Bethge, DER SPIEGEL, of June 9, 2015] Dear Mr. Mitchener thank you very much for your e-mail. Please allow me to rectify a couple of things: There are not three other long-term toxicology studies testing Roundup. I specifically asked you for longterm studies testing the Roundup formulation and not glyphosate alone. The BfR confirmed to me that the Seralini study is the only longterm feeding study using glyphosate-formulations in the published literature. The public is interested in the formulation as the formulation ends up on the fields and in the food chain, not pure glyphosate. Why hasn't Monsanto tested Roundup in a longterm feeding study? Such a study is not required by the regulatory bodies. But such a study would certainly help to build trust. The DER SPIEGEL-article is not "hijacked by an activist agenda". Besides information by people who feel that their lifelihoods are directly threatened by glyphosate, you will only find statements of scientists and information from published scientific literature in the article. This includes information from Prof. Greim, whom you pointed out to me. All the other information you provided boils down to the statements that Monsanto followed all regulations and that glyphosate is well tested according to the current regulations. This information is included in my article. Please include my answer in your blog. Yours sincerely, Philip Bethge Philip Bethge, PhD | DER SPIEGEL – The German Newsmagazine | Web http://www.spiegel.de / http://www.spiegel.de/international
    Reply
    Brandon Mitchener
    |
    June 9, 2015
    Dear Mr. Bethge, Thanks for your response. Our answer to your questions explained clearly why we and the regulators do not do or require research on formulated products. I'll repeat that answer here: [EU] Regulation 284/2013 does not require [formulated] plant protection products to be tested in longer-term toxicity studies. This is because of the regulators base their evaluations on the realistic long term exposure scenarios (mainly to active ingredient), the extremely well-documented, long-term toxicology profile of the active ingredients and the acute toxicity, irritation and sensitization profile of a formulated product. Citing Professor Seralini's discredited research as being better because it needlessly tortures lab rats using non-standard testing methodologies--without any reference to the considerable controversy surrounding Prof. Seralini's research, which was denounced by the European Food Safety Authority and several national food safety authorities, including the German authority--is irresponsible. Moreover, the suggestion that every formulated product should be subject to 2-year animal experimentation is immoral and impractical. It's immoral because there is no scientific added value in doing such studies, as regulators well know. It is impractical because product formulations change constantly. Just think of the "new, improved" toothpastes and dish soaps that you see in the store that often are just reformulations of the same ingredients. Should rats have to be sacrificed each time the percentages of the ingredients change slightly? Most people would agree with regulators that that is unreasonable in addition to being undesirable from an animal welfare point of view. Brandon Mitchener
    Reply
    Brandon Mitchener
    |
    June 10, 2015
    Great new commentary (in German) by a third party on the Spiegel article. http://schillipaeppa.net/2015/06/09/leserbrief-an-der-spiegel-zu-totgespritzt-heft-24-s-118/. The author points out the common sense fact that RoundupReady soybeans and soybean meal is fed to livestock throughout Europe and even globally, so it makes no sense that the use of glyphosate by farmers in South America would lead to problems on only a couple of farms. As the author notes, correlation and causality and very different thtings--but Der Spiegel seems to pay no attention to this, preferring to take the sensationalist line of German scandalmongering public television programs that equate correlation with causality. Could it be that something other than glyphosate is causing the problems? Der Spiegel never even asks the question.
    Reply
    Brandon Mitchener
    |
    June 10, 2015
    Another nice German blog post in response to the Spiegel article. Great comparison between the Great Glyphosate Scare of 2015 and the discredited autism-vaccinations link--which also premiered in the Lancet, btw--from a decade ago. http://www.meta-magazin.org/2015/06/08/der-streit-um-glyphosat-eine-frage-von-gut-und-boese
    Reply
    wannabeshill
    |
    June 14, 2015
    I don't know whether to respond to this in German or English, but I suppose I'll just leave it at one sentence in German for the benefit of Mr Bethge: "Doktor schützt vor Torheit nicht". The science section of "Der Spiegel" has been a laughingstock for a long, long time. Rule of thumb: If you know anything at all about the topic being written about, the haphazard research, the increasingly BILDesque style and the general lack of effort present in the vast majority of Spiegel science articles are somewhere between enraging and hilarious. Mr Bethge, you are pandering to the lowest common denominator and I suspect that you are doing so because you are aware that the majority of the German public is grossly misinformed and undereducated in science (see also: homeopathy, antivaccination activism, "Heilpraktiker" and many, many more publically acceptable products of pseudoscience). You are in a position to rectify this. You should be in love with the scientific method, you should put your ability to evaluate evidence and the joy of having your mind changed above all else. And yet here you are, contributing to the downfall of what was once a respectable and respected magazine, all because the readership you know you have (mostly thanks to the Spiegel Online crowd) is greatly invested in anti-science nonsense. When people ask me why I no longer read Der Spiegel as my parents used to, I point to contributions like yours and the many more like it. I am saddened and disappointed by this, but what was once a fixture in German journalism is hurtling towards irrelevance.
    Reply
    Brandon Mitchener
    |
    June 22, 2015
    Thanks for your comment. That kind of context is really helpful. Unfortunately for us, and for society, Der Spiegel's biased journalism seems more to be the rule than the exception. German and French public TV are the single most destructive sources of "information" related to Monsanto that I can think of. They're squarely in the same camp as Russia Today and Pravda, but whereas the latter do it for anti-Western, anti-American propaganda, it's not exactly clear what public interest is served when German public television uses taxpayer money to fund and broadcast activist lies and propaganda.
    Reply
    Susanne Günther
    |
    July 17, 2015
    Another German newspaper argues today that half of the revenue of Monsanto depends on glyphosate: http://www.sueddeutsche.de/wirtschaft/monsanto-maechtige-lobby-1.2568849 Is that right? Where do I find correct numbers?
    Reply
    Brandon Mitchener
    |
    July 17, 2015
    We publish the contribution of the Crop Protection business to our sales in our annual report. The figures are on page 23 and 24 of the Form 10-Q that we file with the Securities and Exchange Commission. Net sales for the agricultural productivity business were $5.1 billion and EBIT for the segment was $1.35 billion for the fiscal year ended Aug. 31, 2014. That's about 32% of our global sales. The gross profit for the segment as a percentage of sales was about 39%.
    Reply
    Brandon Mitchener
    |
    October 6, 2015
    As a follow-up to the exchange above, we wrote a detailed letter to Der Spiegel outlining our issues with their reporting and presentation of the facts in the article in question. To our knowledge, Der Spiegel never deigned to print any of our letter, or correct their article, only to write a letter in reply to our original letter, referenced above. In the interest of transparency, we hereby publish Der Spiegel's letter to us as well as our response to their response to our response. Der Spiegel's letter: http://monsantoblog.eu/wp-content/uploads/2015/10/Antwort-Spiegel29.7.2015.pdf. Our response: http://monsantoblog.eu/wp-content/uploads/2015/11/Second-Letter-to-Der-Spiegel_final_WEB.pdf.
    Reply

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