The Risk-Monger

 

Also see the French translation

Last week EFSA released three studies on the foliar (sprayed) applications of three neonicotinoids related to bee health, and the results surprised no one. The only surprising result from their three almost copy-pasted press releases, all concluding lack of sufficient data and a possible risk to bee health, is that the civil servants in Parma and Brussels actually think we are that stupid.

This blog will show the following points:

  • EFSA’s research in the three neonicotinoid studies is unscientific and illegitimate
  • The draft Bee Guidance Document that they based their studies on contains field trial requirements that are impossible and impractical (it was designed to fail any and all pesticides)
  • The draft Bee Guidance Document has been rejected by the majority of Member States on several occasions (any policy decisions based on it will be invalid and illegal)
  • The Working Group involved in drafting this new guidance document contained scientists with no bee field trial experience as well as activists involved in campaigns against pesticides and against the Commission’s present risk assessment policy.

Two years ago, EFSA submitted three reports claiming lack of sufficient data as the reason they were unable to exclude the influence of three neonicotinoid seed treatments as a possible factor in declining bee health. Faced with a Europe-wide scare campaign from activists at the time and pressure from the newly elected red-green coalition in France, in early 2013, DG Sanco rushed through a temporary precautionary ban on these plant protection products (despite objections from a large number of Member States and farming associations).

In the two years since, the draft Bee Guidance Document, upon which EFSA drew its initial conclusions for lack of data, has never been accepted; the European Commission was taken to court for taking a decision based on conclusions drawn from this illegitimate guidance document; the Commission’s own research has shown that the decline in honeybee populations is far less than previously feared and has more to do with cold winters, viruses and parasites; and farmers across Europe (in Member States that did not ignore the Commission ban with their own derogations) suffered significant crop losses in 2014. See an earlier blog to support these claims. One would expect that EFSA would either wake up, clean house of the activists and become more scientific, or quietly drift into the background and let the lawyers repair the damage. Instead they have chosen to up the rhetoric – quite illogical.

Bias in the Three Reports

Each EFSA report failed each neonicotinoid pesticide with the same explanation: there was a lack of data or a potentially elevated risk to bees. Shouldn’t red flags go up when three studies all come to exactly the same conclusions? What happened is that EFSA decided to unilaterally change the rules of the game (moved the goal-posts or what most of us call: “cheating”) by introducing new, much stricter standards for conducting field tests on bees. Their claim that there was a lack of data was simply because their requirements were far beyond anything researchers could produce.

So not only did EFSA cheat the research community, they were not very scientific. They picked up each study that was available, held it to their new, overly strict guidance document and concluded either: “Not compliant with EFSA, 2013b” or “The study does not comply with the recommendations of EFSA, 2013b.” EFSA, 2013b is the draft Bee Guidance Document.

Here is the breakdown on how EFSA handled the available research on the three neonicotinoids in question:

Imidacloprid: 24 studies were accepted (all being done in the lab and not in the field), 4 studies were considered as providing no new information, 8 were deemed as not relevant and the 25 field and semi-field trials did not comply with EFSA’s draft Bee Guidance Document and thus were ignored in the peer review. See: Imidacloprid

Clothianidin: of the semi-field or field studies, 6 out of the 6 did not comply with EFSA’s draft Bee Guidance Document and thus were ignored in the peer review while all 4 lab studies were accepted. See: Clothianidin

Thiamethoxam: 6/11 lab studies were accepted as valid for consideration, 7/7 of the semi-field tests and 11/11 of the field tests did not comply with EFSA’s draft Bee Guidance Document and thus were ignored in the peer review. See: Thiamethoxam

So according to the requirements EFSA recently made in their draft Bee Guidance Document, all semi-field or field study risk assessments (49/49) were ignored and only lab studies were considered. Lab studies tend to load up the bees with direct exposures so have a higher rate of adverse affects while most field studies have shown little or no effect on bee health under realistic exposure conditions. By changing the rules to discredit all existing realistic science you save having to bother reading all of those complex studies, you get the conclusion you and your paymasters in DG Santé want and you justify the consequences of the illegal actions taken in 2013. What is not to like about this (except perhaps that it is illegal, inappropriate and unscientific)?

More fundamentally, as I scanned through every study listed on the hundreds of EFSA pages, and each and every field study that demonstrated that there was no risk to bees from neonicotinoids was summarily rejected, it did not take long for me to question the legitimacy of EFSA’s work here. Is this the highest quality of regulatory research in Europe? How could they dare to try to pull off such a debacle? Do EFSA civil servants have any sense of scientific integrity?

The Draft Bee Guidance Document

The draft Bee Guidance Document was published by EFSA in 2013 with an update later in 2013 and then again in 2014 as they have tried on several occasions to get Member States to approve it. The document attempted to unilaterally impose new requirements for how risk assessments on bee health related to pesticides could be done in realistic field trials. The problem is that it was not at all realistic, providing conditions that were either impossible or impractical to comply with.

There are two elements of the draft Bee Guidance Document that defy logical gravity and would pre-ordain the rejection of all field trials and semi-field trials for any pesticides (not just neonicotinoids).

The first is the benchmark for normal hive mortality (reduction size) during the field tests, which the draft guidance document set at 7%. Anything above that threshold would be considered as having an increased risk to bee health. Given that honey-bee mortality in normal circumstances range around 15%, the EFSA draft Bee Guidance Document seems to be demanding that any pesticide tested had to also contain some magical elixir to make bees live longer. It should come as no surprise then that EFSA ruled that all three neonicotinoids under consideration proved to be a possible risk to bee health (anything tested, even placebos, would have been determined a risk given the unrealistic mortality benchmark).
While the unrealistic mortality threshold was a rule change to ensure failure, the second demand of the draft Bee Guidance Document ensured impossibility. This was that the range of the field tests would have to be increased to an area of 7km by 24km (168km²). It would be a challenge to track people over this distance, but if you are studying bees, where they go, what types of pollen they come in contact with, and which are in your field of research, such a field size, to say the least, would be unrealistic. And then there is the space between the test sites and the control sites where no neonicotinoids would be sprayed.

Let me put this into context: a field test area of 7km by 24km is the equivalent of around 31,500 football pitches. Why is this unrealistic? Well, a beekeeper may set up his hives for a pollination range of three football pitches … perhaps for a large pollination contract, up to 31 pitches. But 31,000 pitches??? Somewhere in Parma sits a corrupted civil servant who is wetting himself laughing at the impossible demands that have been placed on industry.

So any field test data produced under the existing risk assessment guidance document (the one that is legal, and legally binding) was insufficient according to the requirements unilaterally imposed by EFSA as it did not include a test area of 31,500 football pitches. Thus EFSA could make the conclusion that there was insufficient data given that all of the field test data submitted no longer complied.

The size beggars belief – 168km² is four times the size of the city of Paris. Are there any farms in Europe big enough to comply with these ridiculous and unnecessary demands? What about having similar control sites where no neonicotinoids are used? What sort of budget would that entail to run these trials? Would all pesticides, including those accepted for organic applications, have to comply to the same standards, or was this all merely a way to appease the NGO activist campaigners making the lives of EU regulators uncomfortable? I keep wanting to tell EFSA we are not that stupid … but as my voice seems rather lonely at the moment, maybe we are.

Oh, and one other point: Assuming that the crop protection manufacturers could comply with the new guidance requirements, and assuming it became a legal document, the conditions were imposed in 2013-14, leaving the industry without enough time to conduct new studies before their products were banned. EFSA changed the rules to the game and then went and disqualified the team before they had a chance to get on the field. That is not only cheating on behalf of an EU body, that is ethically intolerable.

The Rejection of EFSA’s Draft Bee Guidance Document

In 2012-13, when the first studies on neonicotinoids for seed treatment were released, it was revealed that EFSA made their conclusions based upon this draft Bee Guidance Document. Since this internal EFSA guidance document had not been approved by the Member States, the conclusions by EFSA were considered illegitimate and the decision to ban the three neonicotinoids was clearly seen to be an illegal action. Bayer Crop Science and Syngenta, having complied with the existing, legal data requirements, have rightly taken the European Commission to court (and should easily win). In the last two years, EFSA and Santé have been trying desperately to get the Member States to approve their draft Bee Guidance Document, but an overwhelming number of European governments have rejected it (not everyone is as stupid as EFSA officials would like to think!).

So EFSA and DG Santé had a decision to make earlier this year. Do they dilute the demands for field trial risk assessments for pesticides and bees to a realistic level (and re-open their 2013 conclusions on neonicotinoids for seed treatment)? This would likely mean overturning the precautionary ban the Commission had then imposed on the three neonicotinoids. Or do they pigheadedly push forward with the next study on foliar applications using the same corrupted draft Bee Guidance Document, knowing full well that their conclusions would be illegitimate and any decision the Commission might take would be illegal? Well, Parma is famous for its pigs … and also for being very detached from the real world.

The absolutely irresponsible and unscientific approach that EFSA has taken could only be explained by what I would call bureaucratic intransigence. In large organisations, people can often only move their projects through the hierarchy by advancing them to the point that others higher up the chain would have a harder time disapproving what has already been done than simply approving it. Somewhere between Parma and Brussels, they felt that a further set of studies based on the corrupted Bee Guidance Document would somehow legitimise it and force others to approve it. But this is not just a project to be managed by some generalist policy wonks – this affects the ability of farmers to grow crops, consumers to have access to food, trade issues and research integrity (and the Member States see that).

A basic question needs to be asked though: Who in their right minds would set up a guidance document for risk assessments that was designed to fail any substance undergoing a risk assessment? This is where the ridiculous turns to the unbelievable as we consider who is behind the creation of the draft Bee Guidance Document – perhaps the worst EU research Conflict of Interest story since the Santer Commission.

Conflict of Interest

The Risk-Monger revealed last year that the EFSA Bee Risk Assessment Working Group, the body of experts behind the drafting of the corrupted Bee Guidance Document, suffered from serious conflicts of interest. Of the five members, two (Robert Luttik and Jos Boesten) had never worked with bees. Two others (Gérard Arnold and Fabio Sgolastra) have campaigned for anti-pesticide NGOs and Save-the-Bees movements. Sgolastra, a mere post-doc, went so far as to sign a protest letter from Pesticides Action Network that was sent to President Obama, demanding the banning of neonicotinoids. Arnold and Sgolastra have also been publishing papers demanding that the risk assessment process be changed to include more soft science and societal concern. All of this conflict of interest research can be found in my December blog, but since it did not involve any industry conflicts (obviously no industry researchers … or anyone with bee field trial experience has been involved with EFSA for a long time), Corporate Europe Observatory ignored it, as did everyone else.

There is a sweet stench of hypocrisy emanating from Parma and wafting over Brussels. Did nobody consider the blatant conflicts of interest and the Working Group members ongoing activist campaigning? Has nobody noticed the impossibility to comply with the Bee Guidance Document? Is DG Santé not aware that all pesticides, including organic ones, would fail the conditions of this corrupted document? Why are they only focusing on neonicotinoids if they haven’t been infiltrated by anti-pesticide activists? Can they continue to pretend to reject all legitimate studies they do not like by using a corrupted guidance document that the Member States have refused time and time again to approve?

From early August, the (acting) Director General of DG Santé, Miko, was informed that EFSA was using an illegitimate guidance document to try to justify an illegal application of the precautionary principle. Still Miko had allowed EFSA to go forward. This indicates either a complete loss of control of his units, a lack of leadership or a corrupt bias against EU farmers, consumers and the crop protection industry. Any one of these reasons is grounds for his dismissal – Miko is not fit to regulate.

As for EFSA, conversations with friends in Parma reveal an EU body in disarray, with civil servants lacking direction, vision or commitment. Timmermans needs to open his eyes, cut some throats and put some science back into that body.

 

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Comments

  1. Another brilliant and devastating analysis of the unethical and unscientific actions taken by a supposedly science-based organization for partisan political reasons.

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