To facilitate and improve the presence of experts, it is essential that the mission of scientific expertise (Code de la recherche Article 411-1) be better recognized and publicized by employers (research organizations, universities...) but also explicitly taken into consideration in the evaluation of researchers and teacher-researchers.

Like what is done with certain research organizations (such as INRAE or Inserm), the Agency could, within a framework that is either formal (agreements) or informal (participation and interventions in the Alliances and France Universities events, for example), make research institutions aware of the absolute necessity of voluntary involvement of scientists in the Agency's work as a guarantee of the credibility of scientific expertise. Expertise is a crucial mission for researchers in the dialogue between science and society.

Such voluntary action would undoubtedly limit the shortage of expertise in certain fields from which the Anses suffers.

The direct solicitation of laboratories and experts upstream of calls for tenders, a common practice at Anses, increases the range of applications, scientific and methodological expertise, and analysis angles. In this respect, we can mention the proactive approach of the Anses' Social Sciences, Expertise and Society mission, which was successful in setting up the new "Socio-economic Analysis" ESC launched in 2022, with the identification and contact of many laboratories and researchers likely to apply and institutional leaders in the disciplines concerned.

In addition to the national pool, international experts could be mobilized as suggested by an Agency official:

"On specific subjects such as those related to controversial pesticides, there would certainly be an interest in having this type of peer review by undisputed researchers at the international level, especially since an outside view is often useful in principle anyway. Or of course to be able to integrate these scientists in the working groups when possible."

(Anses manager)

An essential element in the attractiveness of the expertise mission is the respect and protection of the expert. In particular, it is necessary to ensure the confidentiality of the debates as laid down in the rules of procedure (Article 8) and not to divulge the names of the experts before the publication of their report and the opinion of the agency to protect them from pressure. The appointment of scientific integrity and ethical integrity referents can only benefit the respect of the rules of expertise.

"If we want to make him work quietly and serenely, he must not be subjected to immediate pressure, and therefore we do not disclose the names of experts before the publication of their report and the opinion of the agency to protect them from these pressures which can be very strong today."

(Anses manager)

"I have not been protected. So I'm careful. I was educated a bit with INRA about the media. If there is something, I immediately warn the hierarchies. I don't really feel targeted. Many journalists ask me questions. I am careful if I feel that things are getting out of hand."

(expert)
Finally, it is important to respect the expertise and opinion of all the experts and therefore to record divergent opinions and minority opinions in the minutes of the meetings, and even in the expert report (articles 6 and 11 of the rules of procedure), in order to avoid a feeling of frustration, useless investment and discouragement.

### 5.2.3. Dealing with conflicts and links of interest

Historically, before the reforms of the 1990s, the choice of experts could be the result of influence struggles rather than scientific competence. Thus, the Gaucho steering group, organized by the Ministry of Agriculture in 1998, included stakeholders, whether representatives of the companies or the Ministry of Agriculture. Since then, the procedures put in place by the Anses to appoint experts are much more rigorous and aim to guarantee, as much as possible, the independence and impartiality of the experts.

"The supposed influence of private actors on public expertise and decision-making has led to the implementation of ethical and transparency rules.

(Lavarde et al. 2020 p.36)

"We are constantly improving the ethics of our collective expertise on conflict and interest review. We sometimes have links that are problematic. We have very rigorous procedures.

(Anses manager)

The application of Article L1452-2 of the Public Health Code and the Health Expertise Charter established by Decree No. 2013-413 of May 21, 2013, involves "examining the links of interest for each section of the public declaration of interest (DPI) filled out by the expert, using the guide for analyzing declared links of interest" (Anses Procedure Anses/PR1/2/01). The Anses guide for the analysis of declared interests²⁵ specifies the boundary between major links of interest (i.e. of high intensity), leading to the exclusion of the persons concerned from the expert groups or to the adoption of deferral measures depending on the dossier concerned, and minor links of interest (i.e. of low intensity), which are a priori compatible with participation in the expert group. The major links of interest are essentially links with a company or an organization likely to be penalized or to benefit from the work of the expert group: professional activity; participation in a decision-making body; individual remuneration for consultancy work; significant individual remuneration for scientific work; provision of significant material resources; intervention with individual remuneration or payment of travel and subsistence expenses; holding of a patent; research contracts representing a significant part of the team's resources. The analysis of the declared links covers a retroactive period of five years. The Agency clearly considers that any major interest with regard to the missions of the group of experts or to the theme to be assessed is a reason for exclusion, even if it means restricting its pool of experts.

In the summary of its work for the period 2011-2016 (CDPCI Anses 2017), the Ethics and Conflict of Interest Committee of the Anses raised the paradox of the missions of researchers who are encouraged by their organization to work with the private sector

<footnote>25https://www.anses.fr/fr/content/guide-d-analyse-des-intérêts-de-l'agriculture-france</footnote>
in order to contribute to innovation and to participate in expertise excluding links of interest classified as major:

"The CDPCI did not encounter any particular difficulties in answering the specific questions it was asked concerning the material links of interest declared by the experts. However, at a more general level, it was unable to avoid noting the paradox to which expertise is subjected. On the one hand, the greatest rigor is demanded in the choice of experts without conflicts of interest; on the other hand, researchers and teachers - researchers who constitute the bulk of the pool of experts - are strongly encouraged to work with or for industry with the legitimate aim of transforming theoretical knowledge into progress for societies.

(CDPCI Anses 2017 p.30)

Nevertheless, this analysis of IPR alone is undoubtedly not sufficient in view of the issues of scientific credibility. Several avenues for improvement were proposed in the joint report of the Inspections générales (Lavarde et al. 2020), which concern, on the one hand, provisions relating to the supervision of benefits ("anti-gift" provision) and, on the other hand, adapted controls of IPR that are currently only declarative.

Finally, the IPR does not address the problem of interests that are more than five years old or that are assessed as minor, but are sometimes considered problematic by some members of the public. There are two opposing views on the treatment of minor interests, one inclusive, the other exclusive. In the first case, as suggested by Philippe Roqueplo in his book Entre savoir et décision (Roqueplo, 1996), one would seek to mobilize all the interests involved in carrying out an adversarial appraisal, on the model of a trial. In the other case, the principle of independence will be strictly applied, which is more or less easy depending on the field. The Anses, having to implement the principle of independence, must manage the tension between competence and independence.

Roqueplo's position was inspired by a broad analysis of interests. Basically, a researcher is never independent of his own interests, starting with the interest for his field of research, which he often advocates. He then considered that the expertise must highlight the philosophy of action and the reference values that will condition the interpretation of the available knowledge. From this point of view, one should certainly not limit oneself to individual links of interest with the industry. In this sense, Henry and Boullier (2021) point out that, regardless of individual ties of interest with industry, some experts internalize the consequences of their expert work on economic activities and have a representation of their work that incorporates the need not to disturb the economic status quo too much. This is certainly an important point that requires great vigilance on the part of the Agency. However, it is certainly necessary to go further, as other interests than those of the industry can obviously be internalized by the experts. This leads to the question of "intellectual ties of interest", which was the subject of a recent opinion by the CDPCI. The opinion identifies the difficulties of recruiting experts without intellectual ties of interest and the risks of the operational implementation of this notion. As already indicated, the participation of SHS in committees can contribute to the objectification of the field of interests specific to a given subject and such objectification can help expert collectives to deliberate in knowledge.
These difficult questions, which are crucial for the credibility of the expertise, will have to be
the subject of further work.

5.3. The GECU: an inappropriate forum for assessing
uncertain and controversial issues

The Anses' internal regulations stipulate that, in case of emergency, the Director General may decide to set up an emergency collective expertise group (GECU). For example, in the event of an avian flu epidemic, the Ministry of Agriculture refers the matter to the Agency for risk assessment and the measures that should be implemented. Given the urgency of the situation, the provisions governing the GECU are more flexible than those for the ESCs and WGs. For example, the members of the GECU are appointed by the Director General of the Agency without a call for candidates or the opinion of the Scientific Council (unlike the ESCs) and without the opinion of the ESC presidents concerned.

In two of the cases studied, the agency created GECUs to mobilize expert advice. In the case of glyphosate, the objective of the first GECU was to identify whether the evidence presented by IARC and BfR supports a change in the classification of glyphosate as a carcinogen; a second GECU aimed to develop the terms of reference for a study on the carcinogenicity of glyphosate. In the case of SDHI, the objective assigned to the GECU was to determine whether the alert launched by a group of researchers provided evidence of exposure and risks that had not been taken into account in the evaluation of the fungicidal active substances concerned.

While the establishment of a GECU is fully justified in the case of an urgent need to act, for example in the case of avian flu, this formula poses a problem in the case of issues characterized by uncertainty or controversial questions. This assessment is the subject of a strong consensus among the persons heard who expressed their views on the subject.

First of all, in order to untangle these difficult problems, it is essential to produce a quality,
contradictory, rigorous and transparent expertise that takes into consideration all the
arguments, that hears the contradictory positions, that evaluates them by mobilizing all the
necessary disciplines. This is essential in order to clearly identify the residual uncertainties,
the points of disagreement and the areas of ignorance.

"The first point that seems important to me, on controversial and difficult subjects, is
to take the time to build and maintain the quality of the expertise
".

(Anses manager)

This in-depth work is all the more justified as new and uncertain knowledge is likely to call
into question the rules of expertise as set out in the guidelines. In the cases studied, it can be
seen that this challenge is not at all obvious, as it potentially shakes up not only economic
interests but also established certainties, paradigms and organizational routines... Not all
new knowledge requires changes in the rules of risk assessment. Nevertheless, it is certain
that the GECU format cannot provide satisfactory answers to the questions that arise when
dealing with controversial subjects.
The setting up of a GECU is justified by the pressure that the agency is under from its
supervisors or more generally from its environment.

"On timelines, put yourself in the shoes of the public policy maker. The state needs to have a scientific agency that can answer these questions quickly. It's inescapable."

(political leader)

But these very tight deadlines are incompatible with the time needed to produce quality
expertise.

"Deadlines and time pressure like we have had (...), with ministries asking for work to be delivered within deadlines that are often difficult for us, almost impossible sometimes if we wanted to do a real collective expertise with all the scientific rigor and transparency that this implies, because it takes time."

(Anses manager)

This situation of paradoxical injunction has several negative consequences. First of all, it
creates a real dissatisfaction for the experts involved, given the impossibility of doing the
necessary work to shed light on difficult questions.

"When you're asked to do something urgently, it's impossible to do something well, especially on a subject like this, it seems to me."

(expert)

"The GECU had only a few weeks at its disposal, which led it to restrict itself to the IARC's summary document, which summarizes its position in 40 pages, but without having the time to analyze the details of the studies. We also took the synthesis of Germany, which was the rapporteur Member State and had produced a large volume (...) With a GECU of a few weeks, what can you do? You can't go through the file, you can't go through the publications."

(expert)

For subjects on which there is disagreement, the constraints of a GECU mean that either the
various experts in the controversy are not included, with the risk of strong polemics on the
report (as in the case of SDHI), or they are sought to be included, and it is then difficult to
produce a quality report within the time allowed.

"I thought the GECU I attended was really messed up. It was useless. It was kind of a gratuitous dud. They brought together people who didn't agree with each other and the Anses got into a whirlwind."

(expert)<fnref n="26" />

It can also be noted that the first GECU on glyphosate and the GECU on SDHI each included
only four experts, while the second GECU on glyphosate included only five experts. This
limited number of experts makes it difficult to conduct a pluralistic and contradictory
expertise.

<footnote n="26">²⁶ Let us recall that the Anses decided to interrupt the process and not to publish the report, which provoked a conflict with the newspaper *Le Monde* following the article by S. Foucart who pointed out that the Anses had "buried the report" (see glyphosate case).</footnote>
But even more seriously, the use of a GECU for such problems can put the Anses in a difficult situation, expose the experts concerned to public accusations and, *ultimately*, contribute to the erosion of the credibility of the expertise. Some actors go further and consider that the choice of treatment of these problems by GECUs is dictated by an intention. In the case of the Glyphosate GECU, the aim is not to call into question the BfR's evaluation.

"In the absolute for glyphosate, I told you earlier that it was a way to sit on the IARC decision. That is why this report was commissioned. That is also why it was requested that it be rapid".

(political leader)

How to get out of this situation?

First of all, it can be observed that the interpretation of urgency is flexible. For the head of a GECU:

"The emergency collective expertise groups are usually for tomorrow. And even then, tomorrow is sometimes a bit late. The term GECU from Anses a few months away has always surprised me. I consider that it is no longer an emergency. (...) Either we assume that it is an emergency group, and it will respond in a few days. It will be easier to assume the uncertainties. Or it is a permanent group.

(expert)

In cases of self-referral (e.g., SDHI) where the agency is not constrained by external deadlines, it is certainly possible to better adjust the mechanism to the case at hand. However, even in the two GECUs set up in response to a ministerial referral, the response times were long, more than six months, which suggests that it would have been possible to set up a WG.

On some topics, it also seems feasible to better anticipate requests. For example, the classification of glyphosate by the IARC was known with certainty since 2015. Several experts consider that a working group on the issue should have been set up much earlier. One of them indicates that he alerted the CES Phyto on this subject without success.

## 5.4. Implementation of the expertise: the collective work

### 5.4.1. Animation and coordination of expert groups

#### 5.4.1.1. The role of the President of the body, a determining personality

The Anses rules of procedure for the bodies specify that "*the chairman of the expert group leads the debates and deliberations. To this end, he is supported by the coordination. In the conduct of discussions, he/she ensures that the principles of collective expertise are respected and promotes an open and respectful exchange of views.*". The chairman ensures that the opinions of each expert are respected, that all opinions are substantiated and justified, coordinates the work of the group of experts and the Anses scientific coordinators (referral amendments, invitations to Anses or external experts, etc.) and organizes the drafting of the
evaluation report. The choice of the chairman of the group of experts, who is responsible for
leading the discussions without imposing his personal vision, is therefore crucial.

"All the groups that worked best were the groups where there was good facilitation, linked in particular to the abilities of the scientific chairs and coordinators, where everyone knew their role well and was fully invested in the expert work."

(Anses manager)

"There are people who are more or less persuasive. There are people who can successfully dominate a group in terms of consensus building. It's a really tricky issue."

(political leader)

### 5.4.1.2. Anses staff and their participation in the group: a pastoral management function

The coordination of the groups is also an important factor in the smooth running of the expertise. In this respect, the Anses internal regulations (2021), which govern the expertise bodies, specify in article 4: "When the group of experts is formed, the Agency specifies the units and agents responsible for coordinating the expertise. The coordinator thus designated ensures that internal procedures are respected. It provides the group of experts with administrative support and a scientific contribution to the work (bibliographical research, analysis of articles, methodological proposals, modelling, statistical analyses, etc.) by The expertise coordinators have a crucial role to play as collectors of data and publications, which are transmitted in whole or in part to the experts for analysis. In particular, the expertise coordinators have a crucial role as collectors/screeners of data and publications, transmitted in whole or in part to the experts for analysis.

However, during the interviews, it appeared that the supervision of the expert groups by the Anses is sometimes a source of tension and the coordination function is not always understood.

"They [the coordinators] need to be familiar with what a scientific coordinator is. It's not a task force expert."

(Anses manager)

"Every year we have a meeting with our expert committee chairs, and unanimously they are very appreciative of the role of our scientific coordinators and the help they provide to the experts."

(Anses manager)

However, there is a lack of understanding of the coordination function of the group of experts between the Anses, which considers that it does not steer the groups of experts but tries to help them, and certain experts who, while recognizing an indispensable secretariat and benevolent steering, sometimes feel hindered in their thinking, and stakeholders who do not always understand the difference between coordination that aims to respect procedures and intrusive steering.
Even more worrying, some experts deplore intrusive and conflicting relations with Anses agents.

"During our initial meetings during the first year, we had not only the presence of Anses agents from the risk assessment directorate, who provided the scientific secretariat for our work, but also their colleagues from the regulated products directorate. They had conflicting relations with certain experts. It was all quite painful. I would not say that they overstepped their function, but we had the impression that the Directorate of Regulated Products was listening to what we were saying. It was a little uncomfortable because there were latent conflicts that were starting to get pretty real between some of the experts."

(expert)

It is therefore important that the rules of procedure for coordinating expertise be made known to everyone (Anses agents and experts) and be strictly applied. In particular, some experts observe that Anses agents do not systematically introduce themselves, do not mention the unit to which they report, or even their directorate (DER or DEPR), and are sometimes more numerous than the experts.

### 5.4.2. The contradictory opinion within the group or the minority opinion: a statutory obligation of the agency to be trivialized

The adversarial principle is one of the basic principles of collegial expertise and conditions the quality of expertise in uncertain and controversial situations. The opinion of the council of ethics and prevention of conflicts of interest of the Anses (Opinion 2017-1) relating to the application of the principle of adversarial approach in expertise: relevance and traceability of minority opinions, was translated into the internal regulations for expertise bodies in 2021, which specifies that "any member may state a position divergent from the conclusion and/or recommendations adopted by the group of experts. In this case, the divergent position is accompanied by an argument. The divergent positions are discussed by the expert group before the adoption of the expert report. Divergent positions are subject to traceability."

The implementation of the adversarial principle is delicate and depends on a number of elements

For example, if a specific skill is only covered by one member of the group of experts, there is sometimes a risk that his opinion will be misunderstood by the other experts and will therefore be in the minority. It is therefore necessary to avoid this situation and to bring the opinion of the Ethics Committee and the rules of procedure to the attention of the experts during the information sessions so that each expert may, if necessary, express a minority opinion. Trivializing such a procedure will certainly make it less conflictual.

"X, on the other hand, did not agree with me at all. He was much closer to the German BfR. At the time, I said that I would not sign the report if we did not find a consensus. I was confronted with Anses officials who pushed for consensus. They did not want one of the experts, and moreover the president, not to sign the report."
In addition to the regulatory aspect of minority opinions, the analysis of uncertainties and the weight of evidence, as recommended in the internal methodological guide for the planning of expert assessments (Anses, forthcoming), the uncertainty analysis, the literature review and the evaluation of the weight of evidence recently produced following the report of the Working Group on Risk Assessment Methodology, will make it possible to avoid overly binary expert conclusions and thus to better take into account the differences in position within the committees. The aim is to implement these recommendations very quickly, as a priority on sensitive subjects, and thus respond to the criticisms recently made by the OPECST in its 2019 report.

## 5.5. The necessary formalization of treatment of alerts

An alert can be defined as the reporting of a potentially serious threat. The treatment of alerts is particularly difficult when taking them into account requires changes in existing cognitive or organizational frameworks. It is then a "weak signal" in the sense of a signal that is difficult to take into account within existing cognitive or organizational frameworks. This is also referred to as a "black swan" (Taleb 2012). Such signals have a particular property: retrospective predictability. *In hindsight*, when/if the threat has been realized, it seems obvious; we then wonder why we did not act sooner and look for those responsible. However, not every report is a real threat. The challenge for the organizations involved is to sort out the issue by minimizing the risk of rejecting a report when there is a real threat while limiting the risk of spending time dealing with false alarms.

For Anses, alerts can be of different natures, including alerts from vigilance and surveillance systems and alerts from the scientific community as well as from other expert institutions. It is this second type of alert that was discussed in the interviews, particularly with regard to SDHI, and which is the focus of this section.

The analysis of the SDHI case shows that the alert launched by scientists has led to accusations against the Anses, relayed by journalists and activist groups, particularly between 2018 and 2020.

Let's first go back to the elements of the diagnosis. The temporal dimension is the fundamental element.

> "I regret that in this SDHI affair, there was not enough time for a calm debate, and that repeated pressure, sometimes at the limit of what is tolerable, was put on the agency before we could even start working on the subject. But I am not blaming one person or another specifically. It is simply an observation about the way society works today, where it is becoming increasingly difficult to take the time to develop expertise in a context of precaution.

*(Anses manager)*

This pressure on the agency is very strong as soon as the alert is public (in this case an article in *Libération*) and becomes an issue for various political, media and other actors.
associations. The sociology of whistleblowers shows that publicity generally constitutes a recourse when the actors involved feel that their appeal is not really taken seriously by the institutions concerned (Chateauraynaud and Torny 1999). In the case of SDHI, the interviews show that two elements were at play: the forms of communication and the differences in the framework of interpretation.

On the side of the scientists who gave the alert, all the people interviewed consider that they have not been listened to, not taken seriously, or even that they have been denigrated.

"For me, it was pretty impressive. I'm telling you this as I experienced it. We were in a structure with a very large table. There were the Anses experts on one committee and us on the other. There were nine of us, with microphones and screens. This hearing began with Pierre Rustin's presentation, which we had worked on together. Some experts were laughing or denigrating what Pierre Rustin was presenting. They showed signs of irritation and anger. At the end of the forty-minute presentation, we began to be bombarded with derogatory remarks and denigration of all the evidence we were presenting. It was very difficult for all of us. We were being scolded. Every piece of knowledge we put forward and concern we had was denigrated in a pretty violent way."

(scientist)

On the GECU side, the memory of this sequence is very different:

"We received the whistleblowers once. We had agreed with Anses that it would be interesting to meet in a room rather than answering each other or bickering through reports. That meeting was tense, but I personally did not feel any extreme tension either. On the other hand, this meeting was later described by the whistleblowers as a very unpleasant time for them. Quite honestly, I did not experience it that way. I'm a diplomat who likes to cut corners and doesn't like conflict. I can tell you that there was no conflict in that meeting.

(expert)

On the side of the agency, an official recalls its will to establish a dialogue with the scientists concerned:

"We may have done it in an awkward or discourteous way. I did not witness the initial exchanges. The emails I saw from Roger Genet were definitely not discourteous or comminatory. Mr. Genet is not a discourteous person. He is the one who got involved in asking for this.

(Anses manager)

One politician who listened to the recording of the meeting described it this way:

"It is very striking to see that there is initially an exchange of data. Very quickly, the meeting turned into a face-to-face meeting between the Anses general management, its representatives and the scientists who had issued the alert and referred the matter to the Anses. The dialogue turned into a mess between an administration that says that the regulation is not based on this, but on such and such elements, and scientists who are in a scientific discussion.

(political leader)

Such a discrepancy is not exceptional in alert situations. But in this case, it is indicative of a communication problem fueled by differences in vision. The whistleblowers
alerters are the spokespersons of a potentially serious problem, identified on the basis of their scientific knowledge. They have high expectations of the institutions.

"We figured that if they didn't have evidence on the likely mitotoxicity of SDHIs, our dispatching an emergency panel of experts could allow the use of these pesticides to be suspended while we review the dossier and the expertise is conducted. We were really in a naive mode. Given the level of concern we had, we were waiting for this reaction.

(scientist)

The institutions are in a logic of application of the rules of which they are guarantors.

"This is a special element. We received the whistleblowers with whom we were able to exchange. We have seen what our respective writings tell us
We each had our own vision. We are certainly each right in our own channel, but the channels do not talk to each other. We are right in our regulatory logic and they are right in their societal and political logic.

(expert)

"I am not hiding from the fact that we are hiding behind the regulatory argument. Today, in the light of the scientific knowledge on both sides, if we bring what the whistleblowers bring to us to the European community, will it ban these products? Our answer is no, because we are a group of experts, essentially toxicologists. We know the regulatory processes. But we don't have among our experts people who have political dimensions or dimensions of "how can we change a regulation?" So we only answer that question from the one small angle that we can answer: does the current state of regulation, which we also don't think is perfect, mean that this new data means that this substance should or could be banned? Our answer is that based on the 2018 data, it should not. You can see that three or four years later with more data, it's still not the case."

(expert)

This difference in framing therefore amplifies the communication problem. For the group of scientists, the literature shows that the mitotoxicity of a class of fungicides massively used in the environment can lead to a series of deleterious effects in terms of human or environmental health. It is necessary to take this effect into account in the marketing authorization tests. Initially, the agency responds within the framework of existing regulatory processes and questions the weight of evidence, the measurement of exposure ... A dialogue of the deaf is thus established.

This diagnosis leads to the formulation of several recommendations, some of which are supported by the actors interviewed.

As noted in other sections, the best antidote to the tyranny of urgency is anticipation.

"And then, to anticipate. When we know that there are opposing experts on this or that subject, regardless of the militant nature of certain experts on one side or the other, when we know that there is going to be lively scientific debate or other issues, we must to incorporate it into the work group, whether we like it or not. (agency manager)
Second, a GECU should be avoided as much as possible as a false good solution to complex and uncertain problems.

"On SDHI, if we had it to do over again, we might try not to go through a GECU. But the problem was that there was so much pressure, both from politicians and activists, that we really couldn't do it any other way.

Ideally, of course, we would have been able to set up the working group from the outset, as we did in the second stage, where we were able to include in the working group people who were initially in the group of whistle-blowing scientists, in order to be sure that contradictory opinions could be expressed if necessary. But it was not possible because of the time constraints at the beginning". (agency manager)

Third, to form a GECU, one of the whistleblowing scientists should have been invited as a member<fnref n="27" />.

"In the SDHI group, there are scientists who had worked with Pierre Rustin on this. They had to be included, they met all the scientific and ethical criteria. Even though scientific debates can be heated and difficult to manage in a working group, it is essential that contradictory positions be expressed when they exist." (expert)

Fourth, better knowledge sharing with whistleblowing scientists would have avoided some of the tensions and misunderstandings.

"The dossiers [for certain SDHIs] were sent to us and they quickly became gibberish for us. Some of the dossiers are several volumes long and each one is several hundred pages long, and Pierre Rustin, who was not a toxicologist, could not understand them. So I started to work with him on the files, knowing that it was a bit complicated for me too. [...] I was quite surprised that we were told to look at the files, but that there was no particular follow-up. We didn't have a window or a person helping us. We could have expected someone to explain the files to us and help us decode. They could have looked with us to see these mitochondrial effects that we had identified, and the consequences that we know about human health". (scientist)

A complementary point concerns the role of other institutions. There is certainly a need to improve the dialogue between scientific bodies and agencies so that the differences in culture and role are better understood on both sides. The question arises as to the role of third-party organizations such as cnDAspe, on which the comments received are discordant.

<footnote n="27">²⁷ See also the CDPCI report on sensitive issues.</footnote>
# 6. Thesis 3. The gap between the expertise and the expectations of the concerned audiences

Let us recall that this thesis is subject to two different interpretations:

* Some consider that scientific credibility is a matter of cognitive bias or "confirmation bias": credibility would then be all the weaker if the expertise goes against the spontaneous beliefs of the population. Conversely, an opinion would be all the more credible if it confirmed beliefs.

* The other interpretation suggests that the credibility of an opinion is all the stronger if the framing of the problems corresponds to the concerns of the publics concerned; in other words, if the opinion answers the questions that these different publics are asking.

The first interpretation is often justified by a conception according to which mistrust of science is on the rise, and science is considered by a large part of the population as a mere opinion. This interpretation, which is a true belief, is fed every time a scientific controversy or a conspiracy theory emerges.

It is important to remove any doubt from the outset and avoid starting off on the wrong track. Trust in science is and remains very high. On the other hand, trust in the authorities in charge of protecting people against risks is different. The question of the credibility of expertise lies at the heart of this paradox.

## 6.1. The paradox of credibility: trust in science but mistrust in the role of public authorities

Politicians, the media and certain scientific organizations frequently assert that our society is marked by a mistrust of science. This preconceived idea is all the more obvious as it is associated with the idea that we have entered a "post-truth" society. However, such a belief is contradicted by the facts. While there are many signs that France is a society marked by mistrust (Algan and Cahuc 2007), science is one of the institutions for which the level of trust is maintained at a very high level. Surveys conducted since 1972 by Daniel Boy of the CEVIPOF have consistently shown this. In his most recent study (Boy 2021), science comes in third place among institutions ranked according to their trustworthiness, with 78% of favorable expressions, behind medical personnel (87%) and hospitals (81%), but far ahead of the red lanterns, the media (28%), social networks (17%) and political parties (16%). The study coordinated by Michel Dubois confirms this very high level of confidence: in 2020, 84% of French people say they have "very much confidence" or "rather confidence" in science. Although there has been a slight decrease since the beginning of the 2000s, this decrease does not increase distrust of science, which remains stable; it is in fact the proportion of undecideds that is increasing (Bauer et al. 2022).

The results are very different when the French are asked about the level of trust they have in the authorities to protect people. The barometer of the Institut de
The results of the IRSN survey on the perception of risks and safety show that the level of confidence is low and varies according to the subject. The highest level of confidence concerns the ability of the authorities to protect individuals from AIDS. At the bottom of the list are endocrine disruptors (16%), pesticides (17%) and nanoparticles (17%) (Figure 3).

These survey data should be taken with caution, given the limitations of declarative measures, the influence of survey administration conditions on the results, and more broadly, attempts to objectify "risk perceptions". For example, the IRSN barometer (2021) mentions that a change in the wording of the question on trust in the authorities caused a drop of thirty points. Added to this is the vagueness and ambiguity of the definition of trust, which further weakens its measurement.

<figure><img src="image_6.png" /><figcaption>Figure 3: A general lack of confidence in the ability of public authorities to protect people (Source: IRSN 2021 p.34)</figcaption></figure>

However, given the number of studies and the diversity of methods used, two results can be retained: (i) general confidence in science is high; (ii) confidence in the authorities to protect populations from technology-related risks (among them, those related to pesticides) is low.

Between trust in science and distrust in public authorities lies the heart of our subject: the question of trust in scientific expertise. The IRSN barometer (2021) indicates that the main qualities expected of a scientific expert, competence (34%), honesty (26%) and independence (20%), are strongly questioned by the respondents.
These indicators, while useful, are far from sufficient to provide a complete picture. While public authorities rely on science and science is widely trusted, why is it that mistrust of the authorities is so high, especially for certain risks? In the other sections, we were interested in the process of producing scientific expertise. Here, we address the question of its reception from the point of view of the people interviewed, who come from different sectors and worlds. Such an approach could be supplemented by additional investigations, using other methods such as closed questionnaires or focus groups aimed at directly grasping the perception and attitude of the publics concerned. Nevertheless, the qualitative results obtained from interviews with experts and stakeholders provide an original and interesting perspective.

## 6.2. Recognition of the agency's work to build trust

### 6.2.1. Various interlocutors underline a discrepancy between the quality of the Anses' work and the criticisms it receives

Among the various stakeholders interviewed, many are surprised at the discrepancy between the intensity of the criticism and the quality of the agency's work. The efforts made are emphasized, both from the point of view of the quality of the collective expertise and the interactions between science and expertise, as well as the implementation of the principle of transparency and dialogue with stakeholders. Particular mention should be made of the role of the Agency's Ethics and Conflict of Interest Committee, which has produced various opinions and reports on subjects related to this report and which plays an important role in the continuous improvement of the Agency's work. The comparison with other agencies, especially international ones, is therefore generally advantageous for Anses.

> "When we went to the European or international level, French expertise is still very well recognized, both on an institutional level, in its contribution, and on a level of capacity to create scientific research or support for the implementation of very useful regulations, even though the issues are very numerous, very complex and there is this principle of separation of risk assessment and risk management."

> "Our object of astonishment is that we had the feeling that in public opinion, the work of the Anses could be stigmatized on certain subjects, even though the methodological conditions of transparency, prevention and ethics were more respected by the Anses than they could be by third parties."

*(Inspector General)*
"This is one of the things that has always struck me: the Anses, which is really the agency that has put forward, anticipated and integrated these questions that are not easy for it, both on plant protection products and others, is finally the agency that is most criticized. (...) To my knowledge, there is no agency on the subject of plant protection and even on others that has dialogue committees, possibilities to interact directly. Today, any company that requests an appointment with the agency, that appointment is traced. You can have the content of the appointment, the same thing for the HATVP [Haute autorité pour la transparence de la vie publique]. Yet, it is still in France that the level of media spikes in relation to these issues you mentioned is by far, but really by far, the most sensitive."

(stakeholder)

Several interlocutors from outside Anses also indicate that on several occasions, the agency has played a pioneering role in the implementation of evaluations that have led to the banning of certain products. This pioneering role, which is probably explained by the importance of the efforts mentioned, should in principle reinforce the reputation of the Anses and its credibility.

### 6.2.2. Stakeholder dialogue structures - an internal communication problem?

The Anses has long been a signatory to the charter on opening up its expertise to society. Thus, in addition to the various measures to ensure the transparency of its expertise, the Anses has taken several initiatives to involve different stakeholders in its work - without, however, co-producing expertise. Thus, stakeholders are regularly heard by the WGs in the framework of the Agency's collective expertise. Similarly, several dialogue committees have been created, quite systematically on subjects considered sensitive: nanomaterials, radio frequencies, and, very recently, biotechnologies. A platform dedicated to plant protection products has also been set up. The aim of these mechanisms is to inform stakeholders about the scientific work carried out by the agency while gathering their expectations and questions. Since its creation, the agency has set up five thematic orientation committees (COT) covering its main fields of activity. These consultative bodies are intended to support the Board of Directors in expressing needs in terms of risk assessment and research, and in defining the Agency's strategic orientations, by bringing to its attention the dominant concerns of civil society in Anses' fields of competence. Beyond the stakeholders, we should also mention the recent launch of reflections and projects around participatory research within the Agency's laboratories.

The establishment of structures for dialogue with stakeholders is rarely mentioned in the interviews. When it is mentioned, it is generally to emphasize the importance of these initiatives for the credibility of the expertise.

"For a few years now, there has been what is called the inter-COT, where there is a desire for transversality within the agency, in the interaction with the stakeholders. This is perhaps already a first step, but I think we could do more on contextualization. (...) I was saying earlier that, very early on, there was this expression, the stakeholder dialogue committee that explained how the process was going to unfold. In this committee, I think any stakeholder, by the way, can raise questions and therefore ask for this or that point to be clarified."

(stakeholder)
"For example, on the subject of electromagnetic fields and mobile telephony, we discussed methodological issues with the members of our dialogue committee and regularly reported on the stages of our work. Not giving results, but saying from the outset how we are going to work, how we select or analyze the bibliography, for example, is very important for the stakeholders so that they can give their point of view, and also provide elements that they consider important for the expertise and which would not have been taken into account by the experts."

(Anses manager)

One of the people we spoke to likened the efforts to open up to society to those aimed at integrating the social sciences, two distinctive characteristics of the Anses.

"In my opinion, one of the two major trademarks of the agency in terms of the renewal of expertise practices over the last fifteen years is its openness to civil society and the social sciences. I say fifteen years because I trace this back to the Afsset, which was somewhat of a pioneer in these matters. (...) These are virtues and I think that we must persist in this direction."

(expert)

Nevertheless, these positive assessments are not shared by all. This is notably the case of an expert who regularly participates in the work of the agency and says that he does not understand the real usefulness of these forums.

"I think there are institutionalized discussion forums. We say that because they exist, public debate exists, but we see that they are not effective in practice. They either need to be changed or they need to be better publicized."

(expert)

### 6.2.3. Two obstacles: media coverage of controversies and totemic subjects

For several of the people we spoke to, expert opinion and health agencies are faced with two major difficulties in establishing the credibility of their opinions. On the one hand, certain forms of media coverage are considered to be capable of distorting the messages of expertise. This may result from the media's preference for sensationalism, sometimes reinforced by the mobilization of certain stakeholders:

"This never stays in the scientific sphere. When you want to destabilize, you open the newspaper, the TV and so on, the opponents of the system never stay in the scientific sphere (...) when you see people who are systematically criticizing the system or attracting attention, sometimes by exaggerating, it never stays in the scientific sphere. To make analyses that are a little shortened, sometimes even completely distorting the scientific studies by cherry picking for analyses that are more media-friendly, unfortunately, that is the daily bread."

(stakeholder)

"It's not just related to that. It's also related to the activism of social movements that is spreading. It is also linked to the evolution of the media space which is more and more receptive to this type of alert. It will seek more to deploy critical information around science in general, the environment and health in particular."

(expert)
The role of the media is pointed out by several interlocutors, including journalists who are
aware of the effect of focusing on certain subjects, which does not always correspond to the
precise hierarchy of health or environmental problems.

"I also understand that there is a kind of journalistic premium on what's wrong. We're more interested in the problems and the trains that don't arrive on time than we are in the trains that arrive on time. It's a bit structural. I understand that some critics were wrong. It's normal that there are some. I am fully aware that there are also many things that are going very well at the Anses and that are done in an irreproachable manner. This is part of the problem, in the same way as when we focus on one product or class of products and everything else is a bit lost. We probably give the public a not-so-accurate view of the hierarchy of health issues. I think we can really be blamed for that. We need to hear it and try to respond. I think it's a real problem."

(journalist)

Nevertheless, it is also the very structure of what some call "scientific-media-political controversies" that needs to be better understood. Several interlocutors point to the central role of "collusion" between the different parties (one could also say coalitions, which may have a more appropriate meaning), including the scientists involved.

"These are scientific-media-political controversies. (...) Why did it become a controversy? Do you think it just happens? A journalist who says: "Here, I'm going to go and look at the calls for tender of the Anses, to see if there aren't things that I can go and scratch a little." Don't you think that this comes from collusion between certain scientific teams and the political world? (...) The other part can be true too. It is not because there is a scientific-media-political collusion that a controversy is "false". There may be some truth, or even all of it (...) But the Anses has been attacked."

(expert)

This question is particularly sensitive when dealing with what can be called totemic subjects. Certain risks and certain substances that are the subject of controversy in the public arena and in the scientific world are caught in a kind of impasse. They constitute emblems and points of fixation that are very strongly invested by the actors, in the image of what we find in the field of health with homeopathy for example. Under these conditions, it is very difficult to make progress in a case, regardless of the scientific data that is produced:

"Can we really today in France and perhaps even elsewhere, work serenely in total detachment? What we had tried to do on highly controversial subjects like this one? Can we do that? I don't know, but I'm afraid not. Because here, we were sure and certain that we didn't care about glyphosate anyway. We said to ourselves what we want to show is: are there any holes? As I told you earlier, are there any gaps in these regulations, phytosanitary and others? That was almost our only ambition. And glyphosate was somewhere the textbook case. That's it (...) I think we don't look enough at the context of these controversies."

(expert)
"Glyphosate is not a sensitive issue per se. It is a sensitive name. (...) There are contradictory presumptions about this molecule. It remains that my conviction as a citizen is that glyphosate reminds us of Monsanto. It reminds us of glyphosate-resistant GMOs. There is a pathos behind this molecule. It is a chemical molecule that has a toxicity, but beyond its toxicity, there is a pathos that makes it impossible for us to say anything about glyphosate either way without being shot at like rabbits. I can't do much about it."

(Anses manager)

Added to this is a sense of uneven play expressed by several experts whose work has been publicly questioned.

"Then, as an ultimate response and deterrent weapon, one of the whistleblowers said that if this happened, they would take this to the newspapers and attack us. All this work is possible, but it creates a clear asymmetry with us who must never have worked with an industrialist, or we hang. We are not allowed to respond in the media, but I don't want to either. We must also have declaration of interest forms that are public and accessible to all. Where whistleblowers have helped answer their whistle, they present themselves as meek lambs who have no conflict of interest, which is totally false."

(expert)

"The most difficult thing is the controversy, because it is quickly poured into the media field. In this field, we have an asymmetrical fight. We do not have the same weapons as our "competitors". We don't want to use the same ones either.

(expert)

Hence, sometimes, a disillusioned feeling.

"When you can't attack the expertise, you attack the experts. That's right."

(expert)

### 6.2.4. How to improve risk assessment communication?

In many interviews, we collected various suggestions for improving risk communication.

#### 6.2.4.1. Communicate on the issues and benefits

For a long time now, discussions on risk communication have pointed out that, since risk is never zero, it would be necessary to indicate the expected benefits in order to enlighten the public concerned. In our interviews, this idea was mentioned by a representative of an industry.
"What I have observed throughout my career is that there is indeed a problem of lack of knowledge, perhaps, or of issues that are not fully understood. Let me explain: why are there plant protection solutions? Because there are plant health problems. And I think that this is totally, not evaded but, in any case, not at the same level as if we were talking about animal health, for example. I'm staying with the comparison here because human health is something else again. But between animal health and plant health, there is absolutely not the same perception".

(stakeholder)

"To go further, I think that this contextualization and this explanation of the meaning and the need for plant health, again, is not within the intrinsic competence of the Anses. I think it should be more in the competence of the Ministry of Agriculture, for example, and the investment should perhaps be more important. Anses could, in my opinion, complement this approach of the Ministry of Agriculture more."

(stakeholder)

Such a proposal raises the question of socio-economic assessment, in addition to risk assessment, a subject that has been very strongly developed by Anses.

### 6.2.4.2. A drafting of notices that does not hide the difficulties of risk assessment

The practices used in drafting Anses opinions are assessed in fairly contrasting ways. On the one hand, some stakeholders recognize the general quality of what is done while making suggestions for improvement.

"I don't think it's poorly explained. I think the communication from Anses is relatively clear. They are keen to make a statement in common language that describes things to us a little bit. I just think that from the point of view of the decision maker, these opinions are often taken as the revealed truth. It's all the stuff we've been talking about since earlier about the limits of regulatory science and the fact that an expert opinion doesn't take into account a variety of parameters because that's the way the regulations are. I think all of that should be more explicit and come earlier in the Anses texts."

(journalist)

On the other hand, some of the actors involved in these issues regret the institutional drafting, which they feel deviates from the expert data and seeks to reassure different audiences, which is not its role.

"Here, the discrepancy between what the international scientific community says about pesticides or other examples of synthetic chemistry and what the agency says jeopardizes the agency's credibility. I am thinking of cases where the agency comes before parliamentarians, with a discourse of relativizing risks in order to reassure them (...) It endangers its credibility on the scientific level (...) Citizens today want a discourse of truth, clinical, cold and without judgment. (...) The data must remain data. It is not a question of wanting to alarm or reassure. We must provide the data and the comparative tools that allow us to understand them. That's all."

(political leader)
The difficulties of risk communication are pointed out by some interlocutors who doubt the ability of the general public to understand technical data. For example:

"The IARC has classified meat as carcinogenic. Behind this, I speak in terms of credibility: what do you want to tell Mrs. XXX by saying "glyphosate is category 1, it must be avoided" - it is true that this must be reserved for professionals, and especially not for the public - and at the same time "meat is also classified as category 1, but it is not forbidden". So there is a whole rhetoric, behind it, of explanation. These oppositions that we have, in my opinion, are destructive for the expertise. (...) I simply wonder if, in the advice we give every day, we need to have these experts behind us. I did not see any statistician in the other groups. Secondly, does the public understand all this? Because when we talk to them about uncertainty, I don't really know... They also expect concrete proposals. You have to be binary with the public: "it's toxic/not toxic," or "we don't know, so we're careful."

(expert)

It should be noted that there is a fairly extensive literature on the issue of risk communication and that the considerable efforts of certain international organizations (e.g., the IPCC and EFSA) are enriching experience and good practices.

Nevertheless, independently of communication aimed directly at the general public, the question arises of the methods used to produce the reports and opinions that are published. In the interests of a culture of credibility, the group endorses the suggestions that go in the direction of great transparency in the drafting of opinions in order to inform about the level of uncertainty, scientific controversies and possible discrepancies between the assessment produced within the regulatory framework and the available scientific knowledge.

* Telling the gaps between the science and what is taken into account by the regulations

"I find that a very clear roadmap laying out this diagnosis and saying, 'We're in this, and that's where some of the disconnect with public opinion comes from, depending on whether people are more interested in listening to expert scientists in the field or saying they trust the regulations.'"

(Inspector General)

* Be transparent about necessary simplifications and default assumptions

"At the European level, the commission says: 'Since we won't be able to test all the cocktails, multi-exposures, etc., we adopt a precautionary factor of x to be defined and we shoot everything down.' This is not particularly scientific, but at least it is pragmatic. Maybe we need to get away from the idea that the regulations allow us to do everything and say, 'Since they don't, I'll find palliatives'."

(Inspector General)
* Clearly state the limits of the risk assessment and be transparent about what is not taken into account

"There are sometimes frailties in the products of expertise that could be assumed by the agency. I think it would be simpler to say that what we did on SDHI may not be very satisfactory, but it corresponded to a certain type of expertise. It was an emergency expertise that we wanted to do quickly. After all, why not? That can be understood.

(expert)

"I think that if we really want to move things forward, every regulatory opinion or expertise on plant protection products should start by listing everything that is not taken into account in these opinions. I am talking about the fact that adjuvants are not taken into account in the marketing authorizations of active substances. I am talking about the fact that the chronic effect of adjuvants is never tested. I don't understand how this is possible. (...) If we are going to make opinions to introduce or reformulate expert reports, we should say all this in the preamble so that these people who vote for the laws are not convinced that there is no problem and that we should go ahead."

(journalist)

## 6.3. Too narrow a scope of expertise

The discrepancy between scientific knowledge and guidelines is frequent and constitutes one of the elements that taints the credibility of scientific expertise. This point has been established by various works, including the OPECST report (2019) and the CDPCI note (2021) (see also Demortain 2021).

The OPECST report (2019) on confidence in the productions of health agencies develops in detail the case of bees. In 2012, EFSA issued a scientific opinion pointing out major weaknesses and gaps in the methodology for assessing the risk of pesticides on bees, not taking sufficient account of chronic toxicity, sublethal effects, larval toxicity and the multiplicity of sources of exposure. EFSA then published a proposal for a new guidance document for the assessment of pesticide impacts on bees in 2013, aiming to replace the 2002 guidance document, which was considered insufficiently demanding.

The OPECST report states that:

"Member State experts sitting on the SCOPAFF refuse to validate the 2013 EFSA document, believing in particular that some studies are unfeasible (the protocol for the return to hive study to investigate the possible effects of pesticide residues on bee behavior is not applicable because the results would not be reproducible). A study carried out at the request of plant protection product manufacturers indicates that the application of the new guidance document would lead to the questioning of 82% of the authorized substances, for which a risk assessment of a higher level than that which exists today would be necessary, which could require the production of new data (residue analyses, field trials, tunnel trials, etc.).

(OPECST 2019, p.108)
One of the thirteen recommendations in this report is that the guidelines be updated regularly:

"#5 Encourage regular updating of guidelines so as not to delay the adoption of new methods and sensitive and reliable tests."

(OPECST 2019 p.162)

The CDPCI report (2021) discusses this issue at length, observing that, in principle, the gap between expertise and academic science should be minimal because, since 2009, regulations require agencies to take into account recent advances (the last ten years of research from academic science). Nevertheless, the report notes that the agency sorts articles according to the weight of evidence provided, which leads to "dismissing interesting research that cannot meet the standards in terms of materials, good practices or methodologies, required by the regulations but beyond the reach of many academic laboratories."

This analysis leads to the following CDPCI recommendation:

"This disjunction between regulatory and academic science - always temporary but often long-lasting - is recognized as one of the causes of public distrust. In the name of transparency on the one hand, and contradictory science on the other, the addition of certain results of academic science, convergent although not yet totally validated, should be mentioned as a track to follow and at least serve as an alert to deepen the subject within a time limit to be fixed."

(CDPCI 2021 p.6)

This limited evaluation framework corresponds to what François Dedieu, a sociologist at INRAE, has called the "invisible cognitive architecture" (Dedieu 2022). Thus, for pesticides, the evaluation focuses on acute risks (and ignores more diffuse risks), proceeds molecule by molecule (no evaluation between several molecules) and is based on the belief in controlled use (for example, confidence in the use and effectiveness of protective equipment - one will put on protective equipment). This invisible architecture rests on three pillars: a) the history of regulatory science, which imposes a form of discreet hegemony of regulatory toxicology on the production of knowledge in this field; b) the tacit arrangement between actors who are a priori opposed (ministry and industry, and even certain NGOs) and who finally agree - for different reasons and to varying degrees - not to question the protocols of regulatory science; c) cognitive: assimilation of "regulatory science" to academic science, which in principle limits its contestation. In the interviews, these issues of the narrow framing of risk assessment were raised in different ways.

### 6.3.1. A critique of case-by-case evaluation

Several stakeholders, parliamentarians and scientists consider that the case-by-case risk assessment is totally insufficient.<fnref n="28" /> We mentioned this above in relation to communication. Here we point to the problem of credibility.

<footnote n="28">²⁸ The need to go beyond case-by-case assessment echoes the research on the exposome that was the subject of a report and opinion of the Anses Scientific Council, adopted in September 2022. It should be noted that a more global approach may also lead to questions about the production system</footnote>
"I do not believe that the problem of credibility of the Anses is linked to the expertise. I think it is linked to the collapse of biodiversity in France. For me, this means that the expert assessments have not worked for 30 years. We can then ask ourselves why these expertises have not worked. Why the Anses or its predecessors were not able to see the catastrophe coming ? This is really the cause of the decrebilization of the Anses."

(scientist)

"When I talk to people around me, the reason agencies have lost credibility is because of the reality people see. It is now described and admitted. It's hard for people to accept. It completely calls into question our safety agencies and how they operate. This has been true for drugs. It's been true for pesticides and for many things that have made something substantively problematic in the expert assessments."

(scientist)

"As you know, the field is vast, the cost of inaction is increasingly documented, there are disturbing characters of environmental effects on health, it is a growing concern for citizens."

(Inspector General)

This discrepancy appears to be one of the factors eroding credibility. It is obviously linked to the limits of the regulatory framework but also to the practices of the Anses. In some cases, the agency has been able to take on cross-cutting issues on its own (e.g. work on bee health), which has led it to question guidelines that ignored important dangers. The capacity for self-referral is an essential element in shifting this strong constraint.

### 6.3.2. Too much influence of the regulatory framework on risk assessment

As mentioned above, the narrow framework associated with the case-by-case assessment is also due, for regulated products, to a selection of knowledge through the prism of the regulatory framework (guidelines, GLP, etc.). The difference in the evaluation of the carcinogenic potential of glyphosate (between IARC and BfR) is due to the fact that the bodies of reference used were not the same. This point is also well illustrated by the case of SDHIs. As the GECU chairman points out, the issue of mitochondrial toxicity was dealt with within the current regulatory framework when it was precisely the adequacy of that framework that was in question:

"The question here was more whether the French regulation, which is a copy and paste of the European regulation (we can't do what we want), means that these substances should be banned today under the current regulation. The answer is no. This leads to this distortion between societal and political aspirations that I can share. (...) I think that this group of whistleblowers has played its role. It was right to do so and it has posed

<footnote>(e.g. intensive agriculture vs. agroecology in the case of pesticides) which, for the Anses, can lead to the integration of socio-economic analysis.</footnote>
good questions. (...) We simply answered them on what we could do today with the regulatory and scientific tools we have, and what we could do better if we had other tools. Their societal and political will does not fit into the framework of our exercise, which is regulatory and scientific. I think the conflict arose from this difference of opinion and way of looking at the issue."

(expert)

### 6.3.3. The influence of industry groups on regulatory frameworks

As various articles have highlighted (e.g. Abraham & Reed 2002), the OPECST report (2019) notes the influence of industrial actors on the definition of guidelines and points to the importance of hybrid organizations such as the International Life Science Institute (ILSI). Funded by industry, it organizes meetings between researchers from public organizations and the companies involved and influences the development of evaluation methods (OPECST 2019, p. 98).

Various interlocutors mention the weight of "lobbies", particularly on the guidelines. This is the most plausible explanation for the non-adoption of the guidelines on the evaluation of pesticides proposed by EFSA in 2013 in the European regulatory framework. Several interlocutors gave this explanation, which is also found in the OPECST (2019) report cited above.

According to one parliamentarian, agencies such as the Anses, despite the procedures implemented, would be more vulnerable to the strategies of "merchants of doubt" formed by certain industrial groups. This is the reason why this type of agency is less credible.

"In my speech that you were referring to a few moments ago, I quoted this amazing report from the WHO. In the 2000s, they make a statement saying that they have discovered and acknowledge that they have been infiltrated for decades by tobacco industry advocates. Their decisions have been influenced by well-placed people on committees and by doubts instilled here and there. They have been influenced and weakened from what they should have been. In itself, the WHO is such a sincere institution. It is not structurally something that defends this or that interest. There are so many representatives, interests and people, and then it's an easy target. If you are a smart lobbyist, you will write on your agenda that you will have to put someone you know well and trust on this or that panel of the WHO or the Anses. It is much more complicated to infiltrate the laboratories of Inria or Inserm.

(political leader)

It is not only the implementation of risk assessment that is problematic but, upstream, the definition of the rules of the game of assessment. While much attention has been paid to implementation, this second aspect, although strategic, has received much less attention.
# 7. Thesis 4. Socio-economic impact of the implementation of risk management measures

Thesis 4 addresses the question of the socio-economic impact of implementing risk management measures. The hypothesis is that an expert opinion, or a decision based on an opinion, is all the more discussed when the estimated impact of the implementation of management measures is high, or, conversely, when the health impact of not implementing them seems high in the eyes of the stakeholders. In addition, the interviews conducted also allowed us to discuss the way in which the Anses takes up this question of socio-economic impact and takes it into account in its work.

## 7.1. Socio-economic issues mentioned in the case studies

In all three case studies, the agronomic and economic stakes appear to be very high and the industrial lobbies are very active and powerful. Several interviewees addressed this issue, each in their own way. As an illustration, here are some excerpts from the interviews:

> "We don't touch pesticides. The Ministry of the Environment is not strong enough to counter the Ministry of Agriculture.

(expert)

> "These important molecule-producing [countries], not to mention Germany, rarely vote for regulations that will cost money and take molecules off the market for their major manufacturers."

(Anses manager)

In the case of glyphosate, a journalist describes the multiple and cascading effects that a ban in France would have, which puts the issue of the political decision on such a subject in a systemic and international context, as these products have acquired an important place in intensive agriculture:

> "[...] If you do that, all the agribusiness sectors in Europe will have very big problems. For example, if you ban glyphosate in Europe, you will be pretty much obliged to put in place mirror measures, otherwise there will be a riot in the countryside. If you do this kind of thing, if you put in place mirror measures and you ban the import of glyphosate-treated soybean meal because it's "Roundup ready" that we grow in Argentina or on the plains of the Midwest, what will happen? It will make the price of a kilo of pork much higher. It will completely hamper the work of animal husbandry, which depends on these imports. You will make an absolutely impossible mess at the WTO. You'll start an unmanageable situation from an economic and geopolitical point of view."

(journalist)
In another interview, it was emphasized that it is important to be concerned about the health of plants if we want to be able to produce and feed the population, elements that tend to be hidden by people who only consider the undesirable effects of pesticides, hence the importance of considering both the risks and the benefits related to the use of pesticides.

> Part of the problem comes from this, because we have completely lost the notion of "what it can be used for", including in public opinion, where, when we raise these types of questions, it is "Ah, you don't have product A, you take product B", "It's not a big deal if there is X less production", etc. We have lost the notion of the importance of solutions, the health of plants and therefore the elements in terms of production factors that can provide an answer, whatever they may be. We have lost the notion of the importance of solutions, of the plant health issue and therefore of the elements in terms of production factors that can provide an answer, whatever they may be, once again. I'm talking about phyto products, but the question of benefit-risk analysis can be asked in a global way."

(stakeholder)

> "I think that this same effort [via the dialogue committees], including vis-à-vis stakeholders, should be made in terms of raising awareness of the plant health issue to perhaps contextualize the implementation of these products that will ultimately be validated with a benefit-risk analysis. If we don't understand the risk, we can't understand the benefit. This aspect, for me, could contribute, if not to credibility, at least to understanding the meaning of the work that is required of agencies. I think that was an important point."

(stakeholder)

On the side of the actors who criticize the use of pesticides, the stakes of public health and ecosystem health explain the strong mobilization of NGOs and scientists to get things moving. On the subject of SDHIs, for example, several testimonies show the impatience of scientists to have these products banned:

> "152 preparations are sold with thirteen molecules. They are sold supposedly because they are better for this or that. It's a complete lie sold to farmers."

> "We saw that the use was exponential and that the number of dossiers submitted for the authorization of substances was also increasing. [...] We felt that this was dangerous. [...] There was the fact that we had to play for time and that the Anses could have taken preventive action on the basis of the solid knowledge we had launched.

> "Mr. X said that there had to be a ban or nothing. [...] X went into a somewhat extreme analysis."

> "When you get daily emails from activist scientists wanting the Agency to deliver results without delay that are their own, it's pretty unpleasant, and sometimes very difficult for our young scientists to live with."

(Anses manager)
## 7.2. Points of view on the positioning of Anses in the conflicts on pesticide issues

It is generally agreed that the reforms of the 1990s, of which the Anses is the heir, have profoundly improved the functioning and credibility of expertise. Although the creation of the Anses has allowed a great advance on the question of the credibility of scientific expertise, it nevertheless appears that it has not completely settled the question in the eyes of several of the people interviewed. They point out several limitations to the work of the Anses in producing an independent expertise in the face of the enormous socio-economic stakes that exist on the themes that concern our case studies. A first argument raised by several interviewees is that the Anses is instrumentalized by the political power to do nothing:

> "If I may, I always use the example of March 22 or 23, 2015. The World Health Organization, based on the work of IARC, announces that several substances are now recognized as probable carcinogens. Several substances are involved, including glyphosate. It is very interesting to note that on the same day that this information is made public, we see two government communiqués for two different substances. There is a release on malathion. It is on the same list as glyphosate. I believe that malathion had already been taken out of use in France, but it had been temporarily reauthorized under very special circumstances. A press release from the Minister of Health said that malathion was banned immediately. A few hours later, a joint press release from the Ministry of Health, the Ministry of Ecology and the Ministry of Agriculture said that the government had taken note of the IARC opinion on glyphosate. This explains why it is asking the Anses to conduct a new study [...]. The credibility of the expertise and its independence at the Anses depends on this technique of evasion by political leaders.

(political leader)

This view is supported by another interview:

> "I think it's clear that this is the case. When we look at the latest case with SDHIs, the expertise is being used as a delaying tool. The warning was given in 2017. We are in 2022. Let's meet here in ten years. I have absolutely no doubt that all these products will be banned. But in the meantime, we have experts working. They write reports that are useless. That's systematically the case."

(journalist)

A second criticism made by some stakeholders is that the Anses censors itself in situations of uncertainty and in the face of the underlying economic stakes:

> "It [Anses] may censor itself for various reasons. One reason is that it evaluates and sees for itself the implications that its evaluations may have. I'm thinking of things that can cause great embarrassment to the government, to the powers that be and to the economic world. She can be restrained in her opinions.

(political leader)
"The financial stakes are so huge, it's so politically complicated, that I think it's very difficult for them to do their job properly. I don't blame them, but I think it's very difficult. The pesticide vendor lobby, I'm not making that up."

(scientist)

Some interviews also mention a conflict of issues within the agency. The fact that the same agency is responsible for both the "food" and "health and environment" domains automatically creates a conflict between health and economic issues.

Within this complex framework of action, it should nevertheless be noted that one expert interviewed reports that the Anses has a rather good reputation in terms of integrity compared to other European organizations in the sector:

"We were hearing in the CES Phyto that France is more of a state considered tough at the European level. [...] Anses has a reputation for fighting long and stubborn battles."

(expert)

### 7.3. The challenges of integrating socio-economic assessment into risk analysis

The Anses COP 2018-2022²⁹ recommends that a reflection be initiated to develop socio-economic analysis in the Agency's work. It provides for "mobilizing human and social sciences in expertise as needed" in three frameworks: shedding light on the objects of scientific and sociotechnical controversy that the Agency must frequently face; conducting or evaluating impact studies of management options required by the regulatory framework; and the need in certain referrals to evaluate the impact of measures recommended by the Agency.

For this type of work, the Agency has been able to rely on the Social Sciences, Expertise and Society Mission, which became the Social Sciences, Economy and Society Directorate (DiSSES) in 2022. In particular, the reflections carried out since the COP was drawn up, notably the internal scientific and technical support report "Socio-economic analysis: assessment and perspectives for Anses" (Anses, 2020c), have led to the strengthening of this last dimension. An ESC dedicated to socio-economic analysis has also been created.

Socio-economic analysis is used in a regulatory context for the evaluation of chemicals falling within the scope of the REACH Regulation³⁰³¹.

<footnote n="29">²⁹ https://www.anses.fr/fr/system/files/ANSES-COP2018-2022pp.pdf, page 1.</footnote>

<footnote n="30">³⁰ As a reminder, although they are subject to the REACH regulation, chemicals are not included in the list of products designated by the Anses as "regulated products", for which the Agency has an ad-hoc definition.</footnote>

<footnote n="31">³¹ In the regulatory field, if the Reach Regulation (EC) 1907/2006 appears to regularly mobilize socio-economic analyses, other regulations can also be mentioned despite lesser uses: Biocidal Products Regulation (BPR) (EU) N°528/2012; Plant Protection Products Regulation (EC) n°1107/2009; analyses of the phytosanitary risk within the framework of the European Regulation n° 1143/2014 on the prevention and management of the introduction and spread of invasive alien species, adopted on 22 October 2014.</footnote>
As part of its activities, the REACH ESC may be required to assess the socio-economic impacts of the measures envisaged in the context of the restriction proposals drawn up by the Anses for the French competent authority. The experience of this ESC shows the usefulness of combining a risk assessment with a socio-economic analysis of the impacts of this risk and the measures to manage it, while highlighting certain limitations of this exercise, in particular because of the asymmetry of information for the public assessor, who has to rely on data mainly from stakeholders (such as industry).

Outside the regulatory context, Anses is progressively developing socio-economic analysis around three types of questions (Anses 2020c):

1. Analysis of the determinants of exposure and health effects, to contribute to health risk assessments: behaviour of sub-populations particularly exposed for socio-economic, demographic or cultural reasons; approaches to inequalities and vulnerability; analysis of sectors, production processes, the construction and structuring of markets;

2. Economic or socio-economic evaluation of the impact of an agent (physical, chemical, or biological, or even of a work organization) or of an activity, in terms of health, environmental or organizational burden: this involves evaluating (not necessarily quantitatively) the pathologies associated with an exposure factor and the associated direct, indirect or intangible costs (i.e., not responding to market logic like the impacts on quality of life)<fnref n="32" />;

3. Evaluation of one or more options for action intended to reduce or prevent health or environmental impacts deemed undesirable, within a regulatory or non-regulatory framework (e.g. information measures, standards, etc.).

With regard to the third type of question concerning the evaluation of options for action, the objective is not to replace a decision that is the responsibility of public decision-makers with a solution given by science. Socio-economic analysis is a matter of evaluation, not management. On the contrary, it is a matter of clarifying the terms of the debate and the possible options, of explaining the different scenarios or possible worlds, in order to make the diversity of possible definitions of the problems and the solutions understandable. To do this, the Socio-Economic Assessment must gather all relevant qualitative and quantitative data. It also integrates, in qualitative form, effects that cannot be quantified. This can lead to multidimensional analyses that cannot be reduced to cost-benefit analyses.

The issue of policy options also implies a broader understanding of alternatives, including not only those that replace one product with another, but also systemic alternatives-for example, in agriculture, non-chemical alternatives of the order of redesigning production systems with the modification of

<footnote n="32">³² It is noted that a socio-political point of view was adopted in the conduct of this type of exercise, as this is the only way to account for the diversity and heterogeneity of certain impacts.</footnote>
of agronomic practices. However, the analysis of alternatives is not only based on socio-economic approaches: it must be multidisciplinary.

The Anses' voluntary and consistent commitment to the integration of socio-economic analysis can change the framework and practice of risk assessment, as has already been suggested by various international and European proposals (Anses 2020c). For this to happen, the involvement of the Social Sciences, Economy and Society Directorate, right from the start of the referral process, is essential. In this respect, several pitfalls may appear. The first is the methods used to answer the questions posed, given that certain aspects can only be addressed qualitatively and that data from very different metrics must be taken into account. A second difficulty is that of access to data to estimate the parameters studied, the precision, reliability and opposability of the data, and the possible biases in their measurement. Thus, the construction/stabilization of methodological milestones for studying and taking into account socio-economic issues, fully considering the uncertainties in the results obtained, is necessary.
# 8. Anses bodies and organization: questions raised by the structure of Anses concerning regulated products

In our interviews, in addition to the four theses, two themes came up frequently: the organization of the agency regarding regulated products and the precautionary principle. These two themes are the subject of these last two chapters.

Anses carries out risk assessment and, in some cases, risk management missions (issuing or withdrawing marketing authorizations) in a range of fields and for a range of products governed by national, European or international regulations. Some of the products subject to regulatory frameworks are distinguished by the agency under the *ad-hoc* term of "regulated products". These regulated products include all products for which the Anses issues and withdraws marketing authorizations (MA): plant protection products and biocides, fertilizers and crop supports, veterinary drugs. They also include plant protection and biocidal active substances, and non-indigenous macro-organisms useful to plants, for which the agency has risk assessment missions, but for which it does not manage authorizations (authorizations that are managed at the European level for plant protection and biocidal active substances, and by the Ministry of Agriculture for non-indigenous macro-organisms useful to plants)

Other products for which the Anses has a risk assessment mission without a risk management mission are not included in the regulated products: this is the case, for example, for chemicals subject to the REACH regulation, whose authorization is managed at the European level.

The structuring within the agency of the missions of risk assessment and management of regulated products, and of risk assessment of non-regulated products, raises various questions and may generate various problems, which were mentioned during the interviews conducted for this work.

## 8.1. A new institutional structure that partially segments the activities related to regulated products

The main characteristics of the institutional structure of the Anses in relation to regulated products are as follows (for more details, please refer to the decision on the organization of the Anses, Anses 2019c). The agency includes a "Regulated Products" division and a "Sciences for Expertise" division (see Figure 1 p.38).
* The "Regulated Products" division is composed of the MA Directorate (DAMM), the Regulated Products Evaluation Directorate (DEPR) and the National Veterinary Medicine Agency (ANMV).

* The DEPR carries out the evaluation of the dangers, risks and effectiveness of regulated products, including, if necessary, for the files of applications for marketing authorization. It also issues opinions and recommendations to the competent authorities in its fields of competence. Three specialized expert committees are attached to it, the CES "Plant protection substances and products, biocontrol", "Biocidal substances and products" and "Fertilizers and growing media", as well as a permanent working group "Macro-organisms useful to plants" (Anses 2021a)<fnref n="33" />.

* The MAH decides on marketing authorizations and permits for experimentation and parallel trade for regulated products for which the Anses provides risk management, based on evaluations conducted by the DEPR (Anses 2021a).

* The ANMV is responsible for the MA of veterinary drugs, the monitoring of adverse drug reactions, the control of pharmaceutical establishments and the market of veterinary drugs.

* The "Sciences for Expertise" division includes the Risk Assessment Department (DER), the Health Alerts and Vigilance Department (DAVS) and the Social Sciences, Expertise and Society Mission (Misses).

* The DER is responsible for the evaluation of nutritional and health benefits and risks related to food and for the evaluation of risks related to health-environment, occupational health, animal health, nutrition and welfare and plant health. It also carries out the evaluation of chemicals in the framework of the European chemical regulations REACH and CLP. The ESCs that do not depend on the DEPR or the DiSSES are attached to it. Some of its expert appraisals concern regulated products: for example, the 2021 Anses opinion on health reference values for chlordecone (Anses 2021b), for which the expert appraisal falls within the scope of the "Evaluation of physico-chemical risks related to food" (ERCA) and "Health Reference Values" CES.

* The DAVS is in charge of a transversal mission within the Agency, related to health monitoring, alert and vigilance. This mission may therefore include regulated products.

<footnote n="33">³³ See also https://www.anses.fr/fr/content/appel-%C3%A0-candidatures-d%E2%80%99experts-scientists-for-constituting-committees%C3%A9of%E2%80%99experts</footnote>
* Finally, DiSSES, which is responsible for developing and coordinating the contribution of social sciences to the Agency's expertise activities, also works to encourage and strengthen interactions with stakeholders - here too, including on regulated products. The ESC
The "socio-economic analysis" section is attached to it.

## 8.2. A reorganization instituting a functional separation between evaluation and management

Historically, the organization into divisions within Anses, effective in 2017, follows the transfer of the management of marketing authorizations for plant protection products, fertilizers and crop supports and adjuvants, which was transferred from the Ministry of Agriculture to Anses in 2015 - a transfer that Anses had not requested. At that time, fears were expressed, particularly within the agency's Scientific Council and Board of Directors, about the consequences of such a transfer in terms of the quality, independence and, more broadly, the credibility of its evaluation. In response, a new institutional arrangement was put in place, distinguishing between the responsibilities of evaluation (taken on by the DEPR) and decision-making (taken on by the DAMM), which were then grouped together in the same "Regulated Products" unit

":

> "On the regulated products side, we have done what was recommended at the time by the Agency's Scientific Council, i.e. we have completely separated the evaluation from the decision. This is an extremely important point. That is to say, when the evaluation is done, the Director of Evaluation on the regulated products side signs his opinion and then the decision is taken. But on the side of the Directorate of Marketing Authorizations that makes the decision, there is no right of review of correction or modification of any kind of the opinion that has been taken by the Directorate of Evaluation of Regulated Products."

> (Anses manager)

According to the report of a 2017 inspection mission, this division of responsibilities then appeared satisfactory to Anses board members (Belet et al. 2017).

## 8.3. An institutional arrangement that raises questions and concerns

However, this structuring can be problematic in several respects. First, for regulated products, the distinction between risk assessment and risk management is not clear to various Anses contacts.
One scientist describes his interactions with the agency this way:

"The people I talked to at Anses [...] covered both assessments and allocations, all the time. That's the only thing I can say. There may be a separation that I don't know about. I feel so much like there isn't. Whether you ask questions about management or evaluation, it's always the same person who has answered me. [...]. I was not told that I should see another person for MAs. [...] I never had one person to talk to when I asked about toxicity and assessment or MA. [...] I can't answer any more. This then comes down to the opacity of the Anses. It is not normal that I cannot answer these questions. It reflects the fact that although I have been in contact with Anses for four years, I still do not know who decides what, who does what or how it is organized. I should know, but I don't."

(scientist)

A journalist interviewed confirms this lack of clarity in his exchanges with the agency, and wonders about the possibility of a structural separation between risk assessment and risk management, beyond the functional separation put in place:

"There is never a distinction [...]. We never know which part of Anses is responding to us. We never know if it is the response from the MA point of view or the risk assessment point of view. We don't have that detail. [...] I think that any Anses agent who answers any question from a journalist on phyto topics giving rise to MAs issued by Anses is influenced in his way of communicating by the double hat of his administration. I don't think they can split into two. I am absolutely convinced that the risk assessment is carried out with the following thought in mind: "At the end of our work, will we have to ban this product? I think that's the thought that's going on in the back of my mind. I don't have the evidence to say so, but it's definitely something that seems obvious to me. I think that this dual competence has somehow contaminated the work of the Anses, at least on the issue of phytosanitary products, which I follow a little more closely than the others.

(journalist)

In this line, the weight of regulatory frameworks in the risk assessment of regulated products also raises questions. An expert scientist from an Agency WG thus notes:

"[...] The transfer of pesticide marketing authorization to the agency in 2015 has not done it much good in terms of credibility of expertise. It seems to me to give too much weight to this regulatory science part of the agency. It was probably already not the most open, but in my opinion it has become even more strained with the political responsibility for product approval. As an expert, I felt it in the WG. [...] It is still against the wind of the history of the separation of risk assessment and risk management. The agency has made its arrangements and put in place a formal distinction. I'm not sure how it works, or how effective it is, but this setup is not great. It's not great. There's too much in the hands of the agency here."

(expert)
Other limitations or constraints that may affect pesticide risk assessments were expressed during the interviews, even when these risk assessments are not conducted in a marketing authorization review setting:

* Lack of diversity in the disciplines and skill areas used for assessment

* The weight of regulations, particularly European regulations, which are themselves constrained by international guidelines

* The tightening of the examination of the questions pertaining to a risk assessment of pesticides, respecting the constraints of the European regulatory framework without underlining its limits

* A lack or weak consideration of academic knowledge that may call into question the authorization of products and the regulatory frameworks that led to this authorization.

The weight of the regulatory frameworks in the expert assessments of regulated products can be illustrated by the ambiguity of the missions of two ESCs attached to the DEPR - the ESCs for "Plant Protection Substances and Products, Biocontrol" and "Biocidal Substances and Products" - as formulated in the calls for applications issued by the Anses in 2019 for the renewal of these two ESCs. On the one hand, in each of these calls for applications, it was specified: "[t]he Anses implements an independent and pluralist scientific expertise to provide the competent authorities with all the information necessary for public decision-making, both at national and Community level". On the other hand, these two calls for applications suggested that the ESCs' missions were restricted to a regulatory framework:

* CES "Plant protection substances and products, biocontrol": "The Agency's mission is to evaluate, within the framework of Regulation (EC) No. 1107/2009 on the on the market of plant protection products, the risks and the interest for plant production of products based on chemical substances (of natural or synthetic origin) or microorganisms and to propose conditions of use for these products "

* CES "Biocidal Substances and Products": "The CES "Biocidal Substances and Products "is to assist Anses on the scientific and technical levels in the framework of of its mission to evaluate biocidal substances and products according to the procedure defined in Article R522 of the Environmental Code."

Thus, the ambiguity of the missions of these two ESCs is to reconcile, on the one hand, the implementation of an independent and pluralist scientific expertise, and on the other hand, the description of a mission constrained by a regulatory framework. However, discrepancies between the state of scientific knowledge and the regulatory framework frequently occur. It is to be feared that this structuring and the culture of these ESCs condition limited possibilities to integrate relevant scientific knowledge not covered by the regulations. This question also emerges from an interview with a member of the "Plant Protection Substances and Products, Biocontrol" ESC.
"You were talking about neonicotinoids. What has always surprised and shocked me is that, for example, the effects of neonicotinoids on bumblebees and solitary bees were never taken into account because the regulatory framework did not require it. However, there were many scientific publications showing that bees were very affected by neonicotinoids. [...] This question was often raised in the ESC. But the answer was logical: the guidelines only ask to look at the effect on bees. The bees had large colonies with recovery abilities, etc. You know this better than I do. It's a malaise that has always existed. [...] It is the way the ESC works and the way we work that makes us look only at the regulatory framework. [...] These were the rules of the game. [...] This is how we operate in this ESC. [...] The way in which the Anses will make its decisions and write its opinions is defined by this framework."

(expert)

At the same time, the DEPR also has the task of proposing changes to regulatory frameworks and guidelines. One may therefore wonder whether this mission is sufficiently developed within the DEPR and whether it has the means to do so, and whether it is sufficiently promoted in the expert groups. A scientist who chaired an expert assessment covered by the "Regulated Products" Unit described the concrete difficulty of going beyond regulatory logic in expert assessment work:

"As experts, if we participate in this expert work, we have to accept the regulations as they are. That's a pretty sensitive point. I'm not sure how we can influence the regulations. [...] Our expert panels don't really have a mandate to go beyond the regulatory difficulties that we have. We have to deal with the regulations as they are. If we don't want to do that, we don't participate in the panel. We participate in panels on other topics. So working in this group is implicitly accepting to work with the tools we have. Otherwise, you quit and say you don't want to work with these tools. But my firm belief is that they should not be dismissed so quickly. They are asking good questions about regulatory toxicology."

(expert)

Some of the concerns expressed here are consistent with the recent report of the Inspectorate General on research, expertise and public health in the field of health and the environment (Lavarde et al. 2020). This inspection mission suggests that a working group involving all stakeholders be set up with the aim of proposing a renovation of the reference framework for risk analysis. It paid particular attention to the case of the Anses:

"Indeed, the gradual diversification of its missions has made the Anses not only a risk assessment and, in part, risk management institution, but also a research operator in distinct fields. From the outset, and with each transfer, the question of its identity and positioning as a health agency has arisen. Ten years after the creation of the Agency, a reflection on the positioning of the Anses could be carried out within the framework of a broader reform of the governance of health and environment. Several options could be considered, including confirmation as a multi-purpose institution in charge of various missions (research, evaluation, risk management), or refocusing on its expert missions with the question of maintaining veterinary laboratories within it.

(Lavarde et al. 2020, p. 62)
# 9. Thesetting in implementation of the principle precautionary principle by the Anses

As mentioned above, the questions raised by the consideration of the precautionary principle were mentioned several times by different interlocutors. These questions are also complex and directly related to the credibility of scientific expertise.

## 9.1. From conceptions different of principle precautionary principle

The history of the precautionary principle is well known (Godard 1997, Kourilsky and Viney 2000). It emerged in the 1970s as a legal principle designed to guide public action in situations characterized by the possibility of serious and irreversible damage when its occurrence is not known with certainty. It is therefore a principle of action in situations of uncertainty, codified by various European texts, in particular the European Commission's communication of 2 February 2000, and introduced into the French Constitution in 2005 (Article 5 of the Charter of the Environment), the highest level of the hierarchy of norms.

> "When the realization of a damage, although uncertain in the state of the scientific knowledge, could affect in a serious and irreversible way the environment, the public authorities will take care, by application of the precautionary principle, and in their fields of attribution, to the implementation of procedures of evaluation of the risks and to the adoption of provisional and proportionate measures in order to avoid the realization of the damage.

> (Constitutional Act No. 2005-205 of March 1, 2005 on the Charter of the environment)

The precautionary principle has always been the subject of controversy. At the first Earth Summit in Rio de Janeiro in 1992, the Heidelberg Appeal, signed by many scientists, denounced "the emergence of an irrational ideology that opposes scientific and industrial progress and harms economic and social development"<fnref n="34" />. The precautionary principle is thus accused of creating "a context that is detrimental to innovation and growth"<fnref n="35" /> and of contributing to the French "decline"<fnref n="36" />. Closer to home in France, in 2015, a group of deputies lobbied to introduce into the normative order an "innovation principle," supposedly to counter the precautionary principle and defend new value-creating activities.

While it is certain that in rare circumstances the precautionary principle may have been misused as a requirement for proof of safety, here we confine ourselves to the definition of positive law, both the legislative and regulatory texts and the decisions of

<footnote n="34">³⁴ The historian François Jarrige points out that the initiative leading to the Heidelberg Appeal was supported by the big oil companies whose strategic interests were threatened. He considers this to be one of the manifestations of the strategies of the merchants of doubt highlighted by Naomi Oreskes and Erik Conway.</footnote>

<footnote n="35">³⁵ See Attali, J. (2008). Report of the Commission for "the liberation of French growth", XO Editions, La Documentation française, pp. 91-92.</footnote>

<footnote n="36">³⁶ Gallois, L. (2012). Pact for the competitiveness of French industry. Report to the Prime Minister, p.39.</footnote>
justice. Legally, it constitutes and, in the vast majority of cases, is used as a principle of
action leading to proportionate and reviewable measures to avoid plausible though uncertain
dangers.

"In the block of constitutionality, it means precisely that in the face of a
threatening disaster, it is the duty of the government to take measures to act to
avert the disaster. So it is not a matter of restraint, but of action."

(political leader)

As shown in the famous report by the European Environment Agency, *Late Lessons from Early Warnings: The Precautionary Principle* (EEA 2001), history shows us that in many circumstances, our institutions have been unable to listen to weak signals, i.e., to take into account information that could have made it possible to prevent poorly known dangers. This is the problem of "black swans", which is well documented in the literature (Taleb 2012) and to which we will return. What about health agencies in general and the Anses in particular?

## 9.2. Precaution and proportionate action: in search of a multi-criteria grid

The interviews express quite clearly the diversity of positions on the precautionary principle.
For some scientific experts, the precautionary principle is clearly a risk management issue. It
is therefore not within their competence. For example:

"The precautionary principle, I don't get involved. For me, it's politics, so it's not my department. I think we have to be very clear about the scope of what we are saying. I always start my sentences with: "With the current state of knowledge, we can say this, this and this and not this."

(expert)

Or again:

"The precautionary principle is not really our role. As experts, our role is to assess hazards. If we know the exposure, we can do risk assessment. (...) Precaution is not the role of experts, but of risk managers. We are here to give arguments."

(expert)

If we take for granted this argument of the separation between scientific and political
evaluation, it is necessary that scientific expertise gives the decision-maker the necessary
arguments to act in a proportionate manner. This requires, first of all, the necessary
qualification of the level of uncertainty. The experience of the IPCC is cited as an example:

"It took 30 years for the IPCC to learn to overcome this and to write in precise language what the terms 'likely' and 'certain' mean. When you look at the literature on the early days of the IPCC (...), you see that in the early meetings of the IPCC, the scientists explode among themselves when they wonder what terms and phrases to use to describe the problem."
"They destroyed themselves before they knew what language to use. The language that the IPCC uses comes across as a bit heavy-handed, with italicized words like "very likely. They describe the level of certainty and uncertainty. In the Inserm report (2021) on glyphosate, the conclusion was changed from "unlikely" to "moderately likely". On a scale of three, with "not very," "medium," or "very likely," they said that after reviewing everything, they were moving it up one notch from "not very" to "medium likely. I think that's the kind of approach we need to have now."

(political leader)

Some of those interviewed went further. On the one hand, in order for there to be proportionate action, it is necessary to clearly define what O. Godard had called the "level of plausibility of the risk".

"The precautionary principle remains a principle of action, of proportionate action according to the levels of evidence and uncertainties on the subject studied. Hence the importance of analyzing them clearly. Our role is to inform the choices of decision-makers, to ensure that their actions take these elements into account."

(Anses manager)

Or:

"We can give our area of uncertainty in CES Anses."

(expert)

However, the level of plausibility of the risk is only one of the elements. As Bernard Chevassus-au-Louis, then Chairman of the AFSSA Board of Directors, suggested, it is necessary to develop a multicriteria grid. This sentiment is expressed by both agency officials and experts:

"The dimensions of risk that will be used to make precautionary recommendations. (...) A whole bunch of criteria that I think are useful to take into account in relation to the precautionary principle, and in recommendations that the Agency would make on sensitive health risk topics."

(Anses manager)

"There are both criteria for applying the precautionary principle, but once you think there is a precautionary principle, there may be criteria for saying what level of action we are going to take."

(expert)

Aware of the need to develop adequate methodologies to assess the plausibility of the hypotheses, the Anses initially mandated a Working Group

"In 2017, this report served as the basis for the recently produced internal methodological guide for expert planning, uncertainty analysis, literature review and weight-of-evidence assessment, also known as the ACCMER report. The purpose of this guide is precisely to put into practice and deploy uncertainty analysis and weight of evidence in expert groups. It is desirable that the ANSES should now focus on implementing these evaluation methodologies as quickly as possible, but also consider the acceptability of damage, observability, the level of irreversibility, the availability of alternative solutions, etc. As we can see, this is pushing towards an interdisciplinary expertise that takes into account socio-economic criteria in a broad way.
Concerning this question of the boundary between risk assessment and risk management, the case of plant protection products is specific in that the agency has this dual competence. An Anses official indicated that proportionate action is the principle followed and that this sometimes leads to restrictions that go further than those of other European agencies:

> "Whenever we can issue specific recommendations in relation to the precautionary principle, we do so. Afterwards, for regulated products, there are marketing authorizations. Decisions are taken on marketing authorizations or on the withdrawal of marketing authorizations. On a certain number of phytosanitary products, we have been precursors, far ahead of other European countries, in particular in trying to have them withdrawn under the precautionary principle in relation to certain study data."

(Anses manager)

However, this view is not corroborated by other direct or indirect evidence collected by our working group.

## 9.3. Reducing precaution to risk assessment?

The calibration of risk management measures in uncertain and controversial situations is a delicate and sensitive matter. The choices made by Anses are not free of criticism:

> "If there is one constant on the three issues I have observed in the recent period between neonicotinoids, SDHIs and glyphosate, it is that there is a real problem of understanding the precautionary principle."

> "(...) On the precautionary principle, Mr. Genet replies:
> On the precautionary principle' - I always insist on the fact that he says that - 'when there is uncertainty, we carry out a risk assessment. This is the basis of the work we have done on each product'.

> This is not the precautionary principle. The precautionary principle obviously consists of research, but provisional measures are also taken to prevent damage from occurring. This is the precautionary principle. There is a real gap in the precautionary principle.

(political leader)

In addition, there is a structural argument. The agency's behaviour in a situation of uncertainty is very dependent on its perception of the room for manoeuvre linked to its relationship with the supervisory authorities and the regulatory framework, organized by European texts. This may explain why the agency makes very little use of the variety of possible measures to act in a proportionate manner (reductions in use, reinforcement of preventive measures, etc.), because of its aversion to the risk of appealing against decisions likely to lead to distortions of competition. Finally, the Agency is also criticized for not taking weak signals into account.
"The Anses and its expertise are used by successive governments and politicians as a n appeal to do nothing. The classic example is that we have a serious scientific alert on a subject, not so much debatable or with tangible elements that give rise to scientific publication in scientific journals with reading committees and peer reviews. In order to do nothing and to draw no consequences in terms of public policy from this scientific war, the government is going to refer the matter to the Anses and ask it to conduct a counter-study to the independent study published in a peer-reviewed scientific journal. (...) Their classic tactic is to ask for additional evidence or evidence that invalidates the first assessments made."

(political leader)

This question of the calibration of measures is therefore essential. It can be added that it remains very opaque and not very readable. The General Inspectorate report on environmental health raises this issue (Lavarde et al. 2020). While much progress has been made on the transparency of risk assessment, the lack of information on the reasons taken into account in the choice of measures leaves room for all sorts of speculation on the interplay of interests, particularly economic ones, that weighed on the decision. This lack of transparency in turn affects the credibility of the expertise.

## 9.4. The Anses in trial, in the name of precaution

In the recent period, the Anses has been condemned twice by administrative courts:

* The judgment of the administrative court of Lyon of January 15, 2019 annulling the decision to market Roundup Pro 36

* The Nice Administrative Court's ruling of November 29, 2019 canceling the marketing authorizations for the insecticides "Transform" and "Closer" based on sulfoxaflor, an active substance approved by the European Commission.

This second judgment is motivated by the precautionary principle as provided for in Article 5 of the Charter of the Environment and in Article 191 of the Treaty on the Functioning of the European Union. The Court emphasizes that, even in cases of uncertainty about the harmful consequences of a product, the precautionary principle must be applied:

"Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty about the risks to human or animal health or the environment posed by plant protection products to be authorized in their territory. (...)
> [Furthermore, "a correct application of this principle presupposes the identification of the potentially negative consequences of a product and a complete risk assessment based on the most reliable scientific data and results the most recent international research. When it proves impossible to determine with certainty the existence or extent of the alleged risk because of the insufficient, inconclusive or imprecise nature of the results of the studies conducted, but the likelihood of actual harm persists should the risk be realized, the precautionary principle justifies the adoption of restrictive measures."

> (Decision of the administrative court of Nice of November 29, 2019)

The precautionary principle therefore implies action, since uncertainty "must not delay the adoption of effective and proportionate measures". In this way, article 5 of the Charter of the Environment mentioned above requires public authorities to implement risk assessment procedures and to adopt provisional (as they will evolve according to the progress of knowledge) and proportionate measures (no doubt depending on the degree of uncertainty).

In a ruling dated July 12, 2021, the Council of State validated the provisions of Decree No. 2018-675 of July 30, 2018 banning neonicotinoids :

> "Neonicotinoids have adverse effects on bee health, both for acute toxicity and for so-called sublethal, i.e. long-term, effects, and severe adverse effects on non-target species that provide ecosystem services including pollination, as well as adverse effects on aquatic invertebrates and, through the food chain, on birds." [...] "Neither the circumstance that limited and temporary derogations from this ban have been granted on two occasions by the French authorities... nor the circumstance that other Member States have not adopted comparable regulations" can justify the use of neonicotinoids."

> (Council of State decision of July 12, 2021)

Despite this ruling, the government responded positively to the request for a derogation from the ban on the use of neonicotinoids to favor the sugar beet sector; thus, the law n° 2020-1578 of December 14, 2020 relating to the conditions of placing on the market of certain phytopharmaceutical products in case of sanitary danger for sugar beets. This law, validated by the Constitutional Council, establishes a temporary exemption to the use of neonicotinoids. Until July 1, 2023, joint orders of the Ministers of Agriculture, Environment and Health may authorize the use of sugar beet seeds treated with neonicotinoids or with substances producing the same effects.

With regard to the first judgment concerning the authorization of Roundup Pro 36, the administrative court of Lyon relied on the same reasoning. In a ruling dated June 29, 2019, the Lyon administrative court of appeal rejected the petitions of Bayer Seeds (formerly Monsanto) and Anses<fnref n="37" />.

<footnote n="37">³⁷ See the judgment and the summary of the case on ALYODA.EU, the case law website of the Administrative Court of Appeal of Lyon.</footnote>
Referring to the controversies surrounding IARC's evaluation of the carcinogenicity of glyphosate, the ruling concludes:

"(...) All of these elements were such as to support the hypothesis of a risk of damage to the environment, linked to the use of glyphosate but also to the association of it with other co-formulants in preparations, likely to cause serious harm to health, at the date of the contentious decision, and justified, in spite of the uncertainties remaining as to its reality and its scope in the state of scientific knowledge, the application of the precautionary principle.

(decision of the administrative court of appeal of Lyon of June 29, 2019)

The reception of these judgments by the agency's managers is mixed, to say the least, which indicates a difficulty on the part of the agency in recognizing the competence of the courts concerned to interpret the precautionary principle, which, it should be remembered, is enshrined in the French Constitution.

"I do not know who is more credible between a judge, a lawyer and a group of experts to say that we have exceeded the precautionary principle or not. I wonder about a certain judicialization of scientific expertise. I wonder about the fact that the judiciary is taking over scientific expertise. I am not saying that we are perfect in our collective expertise. There are always things to improve.

(Anses manager)

"It seems to me that the judiciary is not the best guarantor of scientific expertise. We can hear scientific experts in court, but in the end it is lawyers and judges who choose who they hear. We try to choose panels of experts who do not carry an interest or an opinion supported by anything other than science."

(Anses manager)

Or:

"So, what is my opinion on the Lyon court? For me, it is an opinion issued by an administrative court, political and not scientific, the precautionary principle being in the very methodology of the agency. The problem is to anticipate this kind of situation. I think that this is your problem too (...)

"The problem was not one of substance. For me, it was a problem of form. They relied on that."

(Anses manager)

It should be noted that the position of the judge confronted with scientific uncertainty is particularly delicate since he is exposed to two contradictory criticisms: either that of ignoring the state of scientific research, or, a contrario, that of substituting himself for the scientists without having the legitimacy to do so. In fact, the administrative judge mainly refers to "the current state of scientific knowledge" to justify the absence of consensus or scientific certainty and, consequently, to allow the public entity to continue to carry out the activity in question. The two above-mentioned judgments invoking the precautionary principle are, in this context, particularly noteworthy and should benefit from an in-depth analysis by the Agency.

This is all the more true since, in a pragmatic way outside the field of plant health, in certain evaluation files such as the long-term risks of infantile leukemia and exposure to low-frequency electromagnetic fields, we note that the Anses has been able to use the principle of
precaution, as early as 2010, on the basis of a cluster of concordant presumptions. This attitude was confirmed in 2019 with a recommendation not to establish new schools near very high voltage lines.
Date of validation of the report by the working group and by the Scientific Council:

November 15, 2022
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## 10.2. Legal texts and decisions

CJEU. 2018. no. T- 429/13 and T- 451/13, Judgment of the General Court, Bayer CropScience AG v. European Commission, May 17.

CJEU. 2019a. No. T-329/17, Judgment of the General Court, Heidi Hautala and others v. European Food Safety Authority, March 7.

CJEU. 2019b. No. T-716/14, Judgment of the General Court, Antony C. Tweedale v. European Food Safety Authority, March 7.

State Council. 2021. Decision of July 12. https://www.conseil-etat.fr/en/arianeweb/CE/decision/2021-07-12/424617

Administrative Court of Appeal of Lyon. 2021. 3rd chamber - n° 19LY01017-19LY01031 - Société Bayer Seeds SAS - Agence Nationale de Sécurité sanitaire de l'alimentation, de l'environnement and of travail, 29 June.
https://www.legifrance.gouv.fr/ceta/id/CETATEXT000043753507?dateDecision=&init=true&p
age=1&query=19ly01017&searchField=ALL&tab_selection=cetat

Constitutional law n° 2005-205 of March 1, 2005 on the Charter of the Environment.

Administrative Court of Lyon. 2019. n° 1704067, Comité de Recherche et d'Information
Indépendantes sur le Génie Génétique, January 15. http://lyon.tribunal-administratif.fr/A-
savoir/Communiques/Annulation-de-l'autorisation-de-mise sur-le-marche-du-Roundup-Pro- 360

Administrative Court of Nice. 2019. November 29. N°s 1704687, 1704689, 1705145 and 1705146.

**10.3. Media sources**

Arnold, G. (2018). Banning neonicotinoid insecticides: why did it take over 20 years? The Conversation.

Foucart S. (2017). What the "Monsanto Papers" reveal about Roundup. Le Monde, March 18.
Foucart S. (2018). The "Monsanto Papers", at the root of the glyphosate controversy. Le Monde, August 13.

Foucart (2021a). In 2016, the Anses buried a report on glyphosate. Le Monde, November 16.

Foucart S. (2021b). Cancer and glyphosate: the additional expertise of the Anses will not take place. Le Monde, 1er January.

Foucart S. (2022). Faced with criticism, the European expertise on glyphosate is postponed to 2023. Le Monde, May 12.

Horel S. (2017). Glyphosate: minimal response of the European Commission to civil society. Le Monde, December 12.

Horel S., Foucart S. (2017b). "Monsanto papers": the pesticide giant's war on science. Le Monde, November 26.

Horel S., Foucart S. (2017c). "Monsanto papers", organized disinformation around glyphosate. Le Monde, October 4.

Horel S., Foucart S. (2020). Glyphosate : la déontologie de l'Anses mise en cause. Le Monde, June 16.

Massiot A. (2020). Glyphosate : les liens coupables de l'Anses. Libération, July 25-26.

**10.4. Other sources**

National Assembly. 2020. Written question n° 30248 of Mrs Delphine Batho, 15ᵉ legislature.
https://questions.assemblee-nationale.fr/q15/15-30248QE.htm
Fungicide Resistance Action Committee (2022). FRAC Code List © 2022: Fungal control agents sorted by cross resistance pattern and mode of action.
https://www.frac.info/knowledge-database/downloads

Insecticide Resistance Action Committee (2022). IRAC mode of action classification scheme, June. https://irac-online.org/latest-resources/

Pesticide Property Database, http://sitem.herts.ac.uk/aeru/ppdb/

PAN Europe. 2020. Fraud in German laboratory casts additional doubts on the 2017 re-approval of glyphosate and on the entire EU pesticide safety evaluation procedure. Brussels, 11 February. https://www.pan-europe.info/press-releases/2020/02/fraud-german-laboratory-casts-additional-doubts-2017-re-approval-glyphosate

Portier C.J. et al. 2015. Open Letter: Review of the Carcinogenicity of Glyphosate by EFSA and BfR. https://www.efsa.europa.eu/sites/default/files/Prof_Portier_letter.pdf
Portier, C. J. 2017. Open Letter: Review of the Carcinogenicity of Glyphosate by EChA, EFSA and BfR. https://www.nrdc.org/sites/default/files/open-letter-from-dr-christopher-portier.pdf

Sugimoto, K. 1997. 18-Month Oral Oncogenicity Study in Mice. Unpublished, designated ASB2012-11493 in the BfR Renewal Assessment Report.