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.

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[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:

• Oral toxicity
• Dermal toxicity
• Inhalation toxicity
• Skin irritation
• Eye irritation
• Skin sensitization

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:  LD_50-oral> 5000 mg/kg

Results for the other required acute tests were as follows:

LD_50-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).:

• 90-day feeding study in rat (10 males, 10 females) : NOAEL: 20 mg/kg/day
• Short term (14 weeks) toxicity study in dog: NOAEL : 20 mg/kg/day
• Reproduction toxicity; 2 generation study
  • Study 1 : 20 males per dose, 20 females per dose; 4 dose levels (0-1000ppm)
  • Study 2 : 12 males, 12 females 1 dose (1000ppm)
    • Parental : NOAEL: 38 mg/kg/day
    • Repro : NOAEL: 12 mg/kg/day
    • Offspring : NOAEL: 12 mg/kg/day
• Developmental toxicity : 25 rats per dose group; 4 dose groups (0-300 mg/kg)
  • Maternal : NOAEL: 38 mg/kg/day
  • Fetal : NOAEL:72 mg/kg/day

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.

• For instance, since 1991, glyphosate has been classified by the U.S. Environmental Protection Agency in its most favorable group – Group E (evidence of non-carcinogenicity for humans) The vast amount of new high quality regulatory studies that have been developed ever since only confirmed glyphosat’s non-carcinogenicity classification by regulators around the world.
• Glyphosate is one of the most thoroughly studied herbicides in the marketplace. Robust peer-reviewed studies on glyphosate are available in the public domain and a list of some key publications can be found online at http://www.monsanto.com/glyphosate/pages/glyphosate-and-non-carcinogenicity.aspx.
• Greim et al., in 2015 published a review of the fourteen glyphosate carcinogenicity studies (nine rat and five mouse) that have been conducted over the last 34 years. The authors, like the regulatory authorities, concluded that there was no evidence of a carcinogenic effect related to glyphosate treatment.

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