2.II.1.c. Risk assessment procedures

This is part of the book “Stéphane Foucart et les néonicotinoïdes. The World and disinformation 1“ where I show the journalist misinforms (= false or misleading statements) the reader. One of the myths he develops is that the regulatory response against NNIs has been delayed by industry influence. All quotes are translated (by me), except the ones marked between [ ] in the french version. Quotes from interviews noted between [ ] have been reworked after the interview.


“At the beginning of the twentieth century, almost nobody worried about the quality of the environment and its impact on human health. These were the times of unlimited industrial growth and increasing ‘‘chemicalisation’’ of society, especially just after the second World War. Large scale pollution problems such as the Minamata disease in Japan, first discovered in 1956, were treated as unfortunate incidents.”

Ragas, 2011

First of all, you should know that phytosanitary regulations are relatively recent, there is very little (if any) regulation on environmental risks until the 1970s. For example, arsenic salts were used. and sulfuric acid from the early twentieth to the 1950s. Organochlorines, the first representative of which is the famous DDT. The latter is used from the 1940s and will be used until the 1970s. The image of pristine and pure nature before the NNI is a fable.

Note that the book “Silent Spring”, which raised awareness about the lasting damage that can be caused to the environment, dates from… 1962. It has been a long time since biodiversity has been disappearing under the action of pesticides. Unless it is also a fable…

Arbitration necessary

Then, the risk assessment procedures are discussed since the beginning of their existence. It is their very principle to be debatable, since they reflect an arbitration:

  • If they are too flexible, excessively hazardous pesticides are put into service.
  • If they are too hard, too few phytosanitary products are put into circulation, which reduces agricultural yields, discourages research and closes the market to new entrants (the tests being too heavy and the risks of failure too great, only the large structures could afford to progress in the field) and less frequent crops (which results in depleting the diversity of viable crops for farmers). Note that this would close the way for “green” pesticides, which are nevertheless very active and interesting research avenues for agronomy.

However, the procedures are already very demanding.

Quick presentation of the evaluation

I was able to talk to the director of the UIPP, who gave me more details about the European system.

It is structured in two levels: one European, the other national. The molecule will first have to be authorized at European level and listed in Annex 1 of European regulation 1107/2009 of 10/21/09. For this, it will have to respond to an initial battery of tests. However, it cannot be used this way: each of its formulations must, for each use, be the subject of an additional evaluation by the national health agency (ANSES in France).

“For the different uses, there is a specific assessment that is made at Member State level depending on the use that is requested. The same active substance can be found in dozens of different products with different uses. For example, if there is a use against aphid on the vine, [another use] against aphid on carrot, each time studies specific to each use must be presented. […] Behind the issuance of an MA, […] there is already a preliminary phase which reviews all the potential impacts. This covers [aspects] of health, environment and also efficiency, because it is [also] necessary to prove [that the product brings agronomic interest, in other words that it is effective.]”

Health studies will include aspects of this use with this formulation for the applicator, residents, walkers and consumers. Those on the environment relate to the impact of phytosanitary products on water, air and biodiversity.

This procedure is extremely expensive, and the cost of authorizing a new molecule is estimated to be around 250 million euros.

“[Research in plant protection is quite similar to that in human medicine. To give you a few figures, it takes more than 11 years of research and development to find a new solution until it hits the market.] “

The studies would be based essentially on “prediction models, in relation to water, in relation to the soil, in relation to biodiversity that allow us to predict the behavior of substances, products once they are used in under conditions of use as on the label”. Nevertheless, then, there is a whole arsenal to observe what are, in practice, the impacts of the authorized product:

“In addition, there is the pharmacovigilance tool. France, to my knowledge, was the first country to put it in place. It is therefore a follow-up in real condition, with actual data there, which goes back to ANSES. Data on the qualities of water, air, human health, in relation to the actual use of the product. There, we are no longer on the models. “

“[The evaluation files are based on studies that must be provided (active substances) (formulations), and on European evaluation guide documents which are themselves based]” on “prediction models, in relation to the water, relative to soil, relative to biodiversity that allow us to predict the behavior of substances, products once they are used under conditions of use described on the label ”. Nevertheless, then, there is a whole arsenal to observe what are, in practice, the impacts of the authorized product:

“[In France, the a priori risk assessment system, that is to say in the context of marketing authorization applications, is supplemented by a system for monitoring possible adverse effects, called phytopharmacovigilance .] France, to my knowledge, was the first country to implement it. It is therefore a follow-up in real conditions. The data collected goes back to ANSES. These data relate to the quality of water, air, human health, in relation to the actual use of the product. [Thus they usefully complement the data generated as part of the authorization files.] “

These new data are compiled by ANSES and can be used in particular in the context of periodic product reassessments. They can also be used by ANSES, even before re-authorization, to reinforce the conditions of use (eg: window of use).

“We have seen enormous developments in France with specific obligations that other countries did not have. For example, when it came to using corn seeds treated with deflectors, [to prevent dust dispersion during sowing].”

If undesirable effects are reported, ANSES may even, before the Marketing Authorization expires, re-evaluate the product and possibly ban it.

Each time the MA ends, you have to file for a new one:

“Every time the product is renewed, it is [evaluated] with new scientific knowledge and new requirements. [The required tests are constantly evolving, the substances are assessed with much more restrictive criteria than 20 or 30 years ago.] “

About 70% of the molecules authorized in 1991 are no longer in commerce today, either because regulations have excluded them or because the companies have not sought to continue their exploitation. (Note : This is consistent with my interviews, in which farmers evoke having fewer and fewer products available.)

The complexity of toxicology

The risk assessment is terribly complex, which is not news. For example, the problem of sublethal effects has been known since the 1920s, when the effects of chronic exposure to lead were observed. The principle that there would be a threshold before which there would be no effect was shattered as early as the 1940s, when scientists “discovered that radiation and genotoxic carcinogens can cause damage by a mechanism. biological completely different from those produced by other forms of toxicity.” (Ragas 2011)

“[The problem of determining at what doses an agent is safe, i.e. non-carcinogenic, cannot be resolved unless an acceptable level of risk is defined, however low, rather than claim absolute security.]”

Mantel et Bryan 1961

Toxicology is infinitely complex and, if we wanted to achieve risk 0, we would no longer create any drug, any food supplement, any pesticide, we would ban anything that could emit fine particles, etc. In short, we would turn into a third world country 40 years ago (with the mortality that goes with it).

The importance of pesticides

Finally, let’s remember something we often forget: using pesticides is NECESSARY in agriculture. In many cases, an infestation, whether by insects, fungi or weeds, can result in COMPLETE DESTRUCTION of the crop. This is not a myth, an invention of Monsanto or of a mysterious agro-industrial-chemical-Monsanto-FNSEA lobby. It’s reality.

Agronomic practices (long rotations, soil conservation agriculture (ACS), “low-volume”, choice of varieties, etc.) make it possible to reduce inputs, not to eliminate them (or in very specific cases, such as cultivation. of cereals of several species for self-consumption by a Massif Central farmer interviewed). I interviewed several farmers and all of them used agronomic practices, some very complex and sophisticated, to limit their inputs. All used pesticides (and many regret the ban on NNIs).

The journalist provides no evidence that the flaws in the assessment procedures exposed in the 2012 EFSA report (Boesten et al., 2012) were obvious. He is content to assert it by highlighting a few shortcomings recognized by EFSA, when a considerable body of work should be studied: deepening and referencing the protocols, studying the economic and ecological reasons behind them, etc. Even a specialist researcher who would allow himself such casualness would not be credible.

Thus, this consensus on the impact of NNIs is an invention of S. Foucart. The credibility of this invention rests on its multiple techniques of manipulation and on the ignorance of the general public of the complexity and the stakes of these subjects.


Page bibliography:

  • Boesten, J., Bolognesi, C., Brock, T., Capri, E., Hardy, A., Hart, A., Hirschernst, K., Bennekou, S., Luttik, R., Klein, M., Machera, K., Ossendorp, B., Annette, Petersen, Pico, Y., Schaeffer, A., Sousa, J.P., Steurbaut, W., Stromberg, A., Vleminckx, C., 2012. EFSA Panel on Plant Protection Products and their Residues, scientific opinScientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees, EFSA Journal. https://doi.org/10.2903/j.efsa.2012.2668
  • Ragas, A. M. J. “Trends and Challenges in Risk Assessment of Environmental Contaminants.” Journal of Integrative Environmental Sciences 8, no. 3 (September 1, 2011): 195–218. https://doi.org/10.1080/1943815X.2011.597769.