Citing concerns that glyphosate has been proven to be an endocrine disruptor, along with other health and environmental issues, 67 Members of the European Parliament (MEPs) have written a letter to the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, asking that glyphosate, the main ingredient in Monsanto’s Round Up weed killer, NOT be re-approved.
The letter to Andriukaitis draws attention to the scientific controversy between the European Food Safety Agency (EFSA) and the International Agency for Research on Cancer of the World Health Organization (IARC) with regard to the carcinogenicity of glyphosate. The IARC called glyphosate ‘probably carcinogenic,’ while the EFSA peer review, based on the renewal assessment report by the rapporteur Member State (BfR), concluded that glyphosate is “unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential.”
A regulatory stale mate ensues until the chemicals are properly classified.
Unsurprisingly, Monsanto strongly disagrees with the IARC’s classification of glyphosate, even in light of its own documents being unearthed proving the company knew the substance was toxic for years.
The company also ignores the fact that the IARC report confirmed the findings of the Agency’s previous meta-analysis, which combined the results of several studies and concluded that occupational exposure to glyphosate doubles the risk of developing non-Hodgkin’s lymphoma. The more recent report also highlighted studies which found that farm workers exposed to glyphosate saw an increased risk of multiple myeloma by 70 to 100 percent.
In response to the IARC’s findings, California has moved to add glyphosate to the state’s list of known carcinogens. This would require that Roundup bottles come with some sort of label warning of its dangers. What’s more, multiple countries have issued bans on Round Up until further studies can be conducted.
The EU members state that they do not have the necessary technical expertise to properly assess the detailed scientific arguments brought forward by either side with regard to the classification of glyphosate. However, they draw attention to important issues that need to be addressed, including:
- The number of studies assessed [published vs. unpublished]
- The object of the studies assessed [active substance vs. plant protection products]
The letter states:
“With regard to the first point, EFSA stated that its “evaluation considered a large body of evidence, including a number of studies not assessed by the IARC which is one of the reasons for reaching different conclusions” (EFSA news story, 12 November 2015).
In a detailed response to an open letter sent by MEPs and MPs on 20 October 2015, EFSA gives further indications: “Based on a comprehensive genotoxicity data package on the active substance glyphosate, and considering a weight of evidence approach on all available data, it is concluded that glyphosate is unlikely to be genotoxic in vivo and does not require hazard classification regarding mutagenicity according to the CLP Regulation. It is noted that unpublished studies that were the core basis of the peer review evaluation were not available to the IARC experts as reported in the IARC monograph 112 on glyphosate (IARC, 2015)[own emphasis added].”
The EU members attest, “unpublished studies seen by EFSA were not only the core basis of the peer review, but based on a weight of evidence approach, these unpublished studies trumped the published studies used by IARC and thus led to an opposite conclusion.”
The members go to express deep concern that the scientific vetting process was not transparent. They state:
“This does not create a level playing field, does not allow for independent scrutiny, and as a result inevitably questions the work of EFSA.
We therefore call on you to demand the publication of all the studies which were used by the BfR and EFSA to assess glyphosate and not only their summaries, including names of the authors and declarations of conflicts of interests, so that these studies can be independently assessed.”
The letter also addressed the fact that the EFSA only tested the ‘active’ substance of Round Up, and not the formulated product. The members further write:
“Moreover, EFSA admitted that a number of published studies performed with glyphosate based formulations of unknown composition gave positive results when tested in vitro and in vivo. EFSA furthermore acknowledged that POE-tallowamine is one of the co-formulants that is known to be used in some glyphosate-based formulations, and that « this co-formulant has been shown to be more toxic than the active substance glyphosate on several toxicological endpoints, namely acute, short term, reproductive and developmental toxicity, further to equivocal evidence of DNA damage in vitro at high doses ». However, according to EFSA, POE-tallowamine is not present in the representative formulation.
We are very concerned that an applicant may get approval of an active substance based on one plant protection product alone, especially when many different formulations are placed on the market, most likely choosing a formulation with the least harmful co-formulants, despite the wide use of such highly problematic co-formulants such as POE-tallowamine.
EFSA concluded that the toxicity of formulations and in particular their genotoxic potential should be further considered and addressed, leaving that task to Member States. However, given the hazards shown by formulations, and in particular by POE-tallowamine, and without prejudice to our concerns with regard to the carcinogenic properties of glyphosate as found by IARC, it seems that Member States are not properly applying Article 4(3) of Regulation (EC) No 1107/2009.
We would therefore like to know whether you consider that EFSA complied with Article 4(5) and whether it assessed the most relevant plant protection product in that context, and how you want to ensure that Member States properly apply the provisions of the Regulation, and in particular its Article 4(3) with regard to the authorisation of plant protection products.
Finally, we are greatly concerned that glyphosate may be reapproved prior to the adoption of scientific criteria for the determination of endocrine disrupters. Glyphosate-based formulations have been found to be endocrine disrupters in human cell lines (see Gasnier et al., Toxicology, 21 August 2009). In the absence of proper scientific criteria, EFSA only assessed glyphosate against the interim criteria for endocrine disrupters, yet stated that an endocrine-mediated mode of action could not be ruled out in the context of possible adverse effects on reproduction.”
As you know, the Commission was obliged to present scientific criteria by 14 December 2013, but failed to do so. An analogous obligation is laid down in the Biocides Regulation EU (No) 528/2012. In this context, the General Court declared on 16 December 2015 that the Commission has breached EU law by failing to adopt delegated acts as regards the specification of the scientific criteria for the determination of the endocrine-disrupting properties.”
You can see the complete letter, as well as signatories, here.
Featured image sourced from Nation of Change