Lack of transparency and serious health concerns cited
Sixty-six Members of the European Parliament (MEPs) have written to Vytenis Andriukaitis, the European Commissioner for Health and Food Safety, to request that glyphosate, the most widely used herbicide in the world, is not re-approved in Europe (see their letter below). The MEPs cite a lack of transparency in the re-approval process as well as serious health concerns.
The MEPs are concerned about the opposite conclusions on the carcinogenicity of glyphosate drawn by the European Food Safety Agency (EFSA) and the International Agency for Research on Cancer of the World Health Organisation (IARC). EFSA said the herbicide was unlikely to pose a cancer risk, whereas IARC said it was a probable human carcinogen.
The MEPs correctly highlight a major reason for the discrepancy in opinion: EFSA relied on industry-sponsored studies on glyphosate, which are unpublished and kept hidden from the public and independent scientists, whereas IARC used only studies that are published and open for all to see.
The MEPS also draw attention to the known increased toxicity of complete herbicide formulations as sold and used, over that of the isolated ‘active’ ingredients that are tested and evaluated for regulatory purposes. While it is the legal responsibility of individual EU member states to evaluate herbicide formulations for safety, the MEPs point out that the member states are failing in this duty.
While MEPs fight for public health, EFSA appoints industry spin doctor
And while the MEPs are doing their best to protect health and the environment, what is EFSA doing? Let’s park that question for a minute and go back in time a few months.
Last year we at GMWatch were polled by a research team tasked with working out how EFSA could better communicate its messages to the public. The sum of our advice was: EFSA should forget about the communications aspects and pay attention to its core duty: getting the science right in order to protect public health and the environment.
We said EFSA should demand better quality data from industry and evaluate that data – alongside the data from the open peer-reviewed literature – fairly, openly, and rigorously. Once the science is right, we said, the messaging will look after itself.
We added that once EFSA had got its priorities right, we and our fellow NGOs would help the agency get its public-service messages out there.
Has EFSA taken note of this and similar advice from other campaigners and scientists?
Quite the opposite. EFSA has just appointed Barbara Gallani, the chief scientist of the food and beverage industry lobby group, the Food and Drink Federation (FDF), as its communications director.
Speaking on behalf of the FDF, Gallani has claimed that GM “offers great potential to improve the quality and quantity of the food supply” – a statement that she provided zero evidence for.
And the FDF itself has made statements in favour of GM that are not backed by scientific evidence, while ignoring evidence that does not favour its biased stance.
EFSA’s appointment of Gallani as its communications director suggests that the agency cares more about its own public image than about its duty to safeguard public health.
So we know what we can expect from EFSA in the near future: a slicker defence of poor and non-transparent scientific practice.
Against the reapproval of glyphosate: our letter to Commissioner Andriukaitis
Michele Rivasi and 65 other MEPs, 28 January 2016
Dear Commissioner Andriukaitis,
We, Members of the European Parliament from different political groups, are very concerned by the ongoing re-approval process of glyphosate, the active substance in the most widely used herbicide.
We currently witness a major scientific controversy between the European Food Safety Agency (EFSA) and the International Agency for Research on Cancer of the World Health Organisation (IARC) with regard to the carcinogenicity of glyphosate. While IARC had concluded in March 2015 that glyphosate is a probable human carcinogen (category 2A), the EFSA peer review, based on the renewal assessment report by the rapporteur Member State (BfR), concluded in November 2015 that glyphosate is “unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential”. Proper classification is crucial as it entails important regulatory consequences.
We 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, we consider that there are some overarching problems that urgently need to be addressed.
According to EFSA, there are two key issues that explain the different conclusions:
a) the number of studies assessed [published vs. unpublished],
b) the object of the studies assessed [active substance vs. plant protection products].
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]. »
In other words, 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.
We are deeply concerned about such an intransparent weight of evidence approach, based on which positive findings (in published studies) are outweighed by referring to negative findings (in unpublished studies). 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.
With regard to the second point, EFSA has recently gone on record that its task would be to assess the active substance, not the formulated product (Huffington Post, 21 January 2016). While it is correct that the authorisation of the diverse formulated plant protection products is the responsibility of Member States, EFSA also has key obligations in that regard. According to Article 4(5) of Regulation (EC) No 1107/2009, for approval of an active substance, the approval criteria shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. It is thus clear that EFSA also needs to assess at least one plant protection product against the approval criteria, and in that respect pay full attention to all relevant data, including epidemiological one. The EFSA statement referred to above raises important questions with regard to the compliance of EFSA’s peer review with Article 4(5).
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.
In conclusion, we urge you to refrain from re-approving glyphosate as long as
• key studies used for the assessment remain confidential or unpublished,
• glyphosate-containing formulations are not properly and fully assessed,
• the Commission has not adopted specific scientific criteria for the determination of endocrine-disrupting properties.
Vice-Chair of the Greens/EFA Group in the European Parliament
With the support of:
Isabella Adinolfi (EFDD)
Marco Affronte (EFDD)
Laura Agea (EFDD)
Daniela Aiuto (EFDD)
Pascal Arimont (EPP)
Margaret Auken (Greens/EFA)
Guillaume Balas ( S&D)
Beatriz Becerra Basterrechea (ALDE)
Paloma López Bermejo (GUE/NGL)
Biljana Borzan (S&D)
José Bové (Greens/EFA)
Lynn Boylan (GUE/NGL)
Klaus Buchner (Greens/EFA)
Fabio Massimo Castaldo (EFDD)
Ignazio Corrao (EFDD)
Rosa D’Amato (EFDD)
Dennis de Jong (GUE/NGL)
Karima Delli (Greens/EFA)
Mark Demesmaeker (ECR)
Pascal Durand (Greens/EFA)
Stefan Eck (GUE/NGL)
Bas Eickhout (Greens/EFA)
Peter Eriksson (Greens/EFA)
Eleonora Evi (EFDD)
Jil Evans (Greens/EFA)
José Inácio Faria (ALDE)
Laura Ferrara (EFDD)
Ana Gomes (S&D)
Sven Giegold (Greens/EFA)
Jytte Guteland (S&D)
Rebecca Harms (Greens/EFA)
Martin Häusling (Greens/EFA)
Heidi Hautala (Greens/EFA)
Maria Heubuch (Greens/EFA)
Anja Hazekamp (GUE/NGL)
Yannick Jadot (Greens/EFA)
Benedek Jávor (Greens/EFA)
Eva Joly (Greens/EFA)
Josu Juaristi Abaunz (GUE/NGL)
Karin Kadenbach (S&D)
Kateřina Konečná (GUE/NGL)
Merja Kyllönen (GUE/NGL)
Jean Lambert (Greens/EFA)
Philippe Lamberts (Greens/EFA)
Ulrike Lunacek (Green/EFA)
Maria Noichl (S&D)
Maite Pagazaurtundúa Ruiz (ALDE)
Gilles Pargneaux (S&D)
Piernicola Pedicini (EFDD)
Pavel Poc (S&D)
Terry Reintke (Greens/EFA)
Bronis Ropé (Green/EFA)
Mari Saarteinen (Greens/EFA)
Jordi Sebastià (Greens/EFA)
Molly Scott Cato (Greens/EFA)
Lidia Senra Rodríguez (GUE/NGL)
Bart Staes (Greens/EFA)
Dario Tamburrano (EFDD)
Keith Taylor (Greens/EFA)
Estefania Torres Martinez (GUE/NGL)
Claude Turmes (Greens/EFA)
Ernest Urtasun (Greens/EFA)
Marco Valli (EFDD)
Marco Zanni (EFDD)
Marco Zullo (EFDD)