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French Agency for Food, Environmental and Occupational Health & Safety

Information from ANSES following the article of 16 June 2020 in Le Monde

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News of 19/06/2020

An article in Le Monde on 16 June, based on comments by anonymous individuals described as "whistleblowers" and a question to the government by French MP Delphine Batho, criticised the fact that scientists asked by ANSES to reflect upon toxicology studies were then selected by the Agency to conduct these studies following the call for applications.

The aim of this scientific study arrangement was to provide additional data to answer the question of glyphosate’s toxicity, and particularly its potential carcinogenicity for humans. It followed a formal request made to ANSES by the Ministries of Health, Agriculture and the Environment in March 2018.

As a reminder, glyphosate — a herbicidal active substance — will be re-assessed in 2022 in accordance with European regulations governing the marketing authorisation of plant protection products. Following the controversies that marked the previous re-assessment of glyphosate in 2017, largely fuelled by the lack of independent and robust scientific publications on the topic, expectations regarding additional data on its toxicity are particularly high.

Conducting studies to meet this challenge implies three requirements: rapidity (the new data will have to be added to the re-assessment dossier before the end of 2021); the ability to produce results that can be compared with data produced by manufacturers according to precise regulatory specifications; and the mobilisation of public university laboratories.

To respond to the first requirement, as soon as the ministerial request was made, ANSES set up an Emergency Collective Expert Appraisal Group (GECU). This form of working group, convened without a call for applications, was the only one that would make it possible for a group of scientists to be brought together in under six months to quickly begin drafting the specifications. The GECU, consisting of three French scientists and two foreign experts, completed its work in December 2018.

To respond to the second requirement, the GECU experts recommended that the genotoxicity studies to be conducted comply with good laboratory practice (GLP) because, in the regulatory framework, this demanding standard applies to the genotoxicity tests manufacturers have to carry out for the active substance assessment dossier. A level equivalent to GLP was also recommended for the other studies to be conducted, to ensure that the results are taken into account in the re-assessment process. These requirements, as well as the precise nature of the various tests to be conducted, were validated by the ANSES Expert Committee in charge of examining the GECU report, and then finally by ANSES in accordance with the collective expert appraisal procedure followed by the Agency. The Agency's code of ethical standards was applied at each stage. The ANSES opinion (in French) was finalised in March 2019 and published on 22 July 2019.

Having outlined the study arrangements, and because of its methodological specificities and the context of controversy surrounding glyphosate that could potentially discourage some scientists, ANSES decided to proceed with an international call for applications in order to maximise the potential number of responses. This call for applications, limited to public university laboratories, was addressed primarily to laboratory consortia and required a declaration of interests to guarantee the independence of the work to be conducted.

While the terms “call for tenders” and “specifications” were used for convenience, the Agency points out that this unusual consultation process did not fall within the scope of public procurement.

Despite its efforts to promote this call for applications widely, ANSES received few responses, with applications from just two consortia – of seven and four laboratories respectively – and two single laboratories meeting only certain aspects of the specifications. Only one consortium met all the specifications. Both consortia included teams linked to scientists who had participated in the collective expert appraisal groups involved in formulating ANSES’s opinion on the studies to be conducted.

The very point of opening up the call for applications to both national and international candidates was to try and avoid this type of situation. Given the low number of responses received, the even lower number of responses matching expectations regarding GLP competences, and the relevance of these responses with regard to the overall scientific challenge, ANSES opted for the default (albeit scientifically relevant) option in late April 2020: to select the consortium led by the Institut Pasteur of Lille – which although one of its coordinators had participated in the GECU expert group, was the only one to fully comply with the required expertise framework – as well as a novel study proposal from one of the partners in the other consortium, the IARC.

With regard to the questions raised, ANSES is re-examining the possibilities of providing a satisfactory scientific response despite the strong constraints observed, while retaining the option of producing data in the format specifically requested, and within the time available.