A few days ago Natural England announced that, for this year’s badger culls, a “total of 29 applications or expressions of interest for a badger control licence” have been received.

They come from Cheshire, Cornwall, Devon, Dorset, Gloucestershire, Herefordshire, Somerset, Wiltshire and Worcestershire.

According to south-western media, 25 of these applications are for areas within Cornwall, Devon, Somerset and Dorset. Which leaves just 4 covering the other 5 counties!

When the government held a public consultation on badger culling, the previous Labour government having decided, as a result of the Randomised Badger Culling Trials, not to implement a cull, it received 59,000 responses, very many of them raising serious scientific concerns.

Regardless, the government announced in 2010 that “a carefully managed and science-led policy of badger control” would be introduced; their ‘rules’ stated that culling must take place over a minimum area of 150 sq.km so “we can be confident it will have a net beneficial effect.”

Consult – and ignore

This despite the Randomised Badger Culling Trials having concluded culling badgers would ‘have no meaningful effect’ in preventing the spread of bovine TB. Goodbye, science.

In the autumn of 2015 another public consultation was held about proposed changes to the criteria governing culling. Those results were ignored too, Liz Truss happily announcing that “further statistical analysis” of the RBCT (whose results have been constantly misquoted by the government) and “post-trial analysis” allowed for the minimum culling area to come down from 150 to 100 sq.km.

The RSPCA, in its response to the government’s 2010 consultation (a must read), pointed out that the post-trial analysis had already been considered by the previous government when taking the decision not to engage in badger culling. Yet again, the Environment Secretary is misrepresenting the facts.

Even worse and despite the firm recommendation of the RBCT to confine culling to a 6-week period (causing the least pertubation of badger populations possibly spreading the disease), she made it far more convenient for the farmers. Basically, apart from the closed season when cubs are being reared, it’s now almost open season.

Cullers don’t like small areas

However, culling contractors prefer large areas, hoping that the sheer miles involved will discourage those people trying to defend badgers from the guns. According to NE, the applications cover areas ranging from from 135to 655 sq.km, with the average area being approximately 330 sq.km.

Note: for those who walk, drive and think in miles, those figures are 52.1, 253.8 and 127.4 square miles respectively.

How can one achieve an even half-accurate estimate of the badger population in an area of 127 or 252 square miles that could contain major differences in geology, soil and landscape? Yet it is on this dodgy estimate that the number of badgers to be culled per year is decided by Natural England. But NE doesn’t have the staff to cover the ground and farmers consistently overestimate how many badgers a sett holds.

Many do not understand that a single group of badgers may have more than one sett. Or that a long established sett may have over 30 entrances / holes, yet no more than 5 or 6 badgers in residence, the average family group being 5.9 badgers. One farmer’s over-estimate for the number of badgers on his land amounted to three badgers per acre. Rabbits maybe. Badgers no.

Is culling badgers the only option?

No. In 2011 the European Commission carried out an audit on the UK’s efforts in controlling bTB in cattle. The report was damning, highlighting many areas where adequate testing, cattle movement controls and biosecurity measures were quite simply inadequate.

The UK produced some defensive comments on the report (the word ‘wildlife’ appeared just once, and ‘badgers’ not at all) and then a proposed plan to deal with the situation, implemented in 2013. But until England follows the route taken by Wales (e.g. annual TB testing on all cattle, not just in selected areas), England’s farmers will still struggle to gain control over bTB.

Biosecurity on farms is an absolute must if one is serious about controlling any form of disease (bird or swine flu for example) that might be transmitted by wildlife or stock on neighbouring farms, particularly when one considers that intensive farming methods compromise the immune systems of the animals, making them more vulnerable to infection.

But how many farms do you have to see with your eyes wide shut before noticing that too many are still lax in their biosecurity controls – putting not just themselves at risk, but also those farms in the area that do take matters seriously.

Easy as it is to blame the wildlife, the far greater risk comes from herds where bTB is endemic. The farming industry, not badgers, needs to bite the bullet. 

What ‘infected badger populations’?

Defra talks about ‘infected badger populations’, but in all this pseudo science there is no effort to investigate how much bTB really is present among badgers.

During the first two years of culling in Somerset and Gloucester, no badgers were tested for bTB. Rumour has it that an independent laboratory is now thinking of doing such a study on badgers in one of the Western Region counties. But surely, if the government wants to go on claiming this is a ‘science-led policy’, it must conduct its own rigorous, unbiased and transparent investigation?

It won’t, of course. Such a study would only demonstrate that badgers are nowhere near being a major part of the problem. Further, any government-funded reports that don’t agree with its policies may be muzzled.

One can expect neither sense nor science from a government that appears to be allowing the closure of the National Wildlife Crime Agency. For the majority of us, culling badgers is one of those crimes.

Lesley Docksey is a freelance writer who writes for The Ecologist and other media on the badger cull and other environmental topics.

See other articles by Lesley Docksey.

In March 2015 the World Health Organisation’s International Agency for Research against Cancer (IARC) found the world’s most commonly used herbicide, glyphosate, “probably carcinogenic to humans”.

Three months later the EU’s official risk assessment of the pesticide, conducted by the European Food Safety Authority (EFSA) and Germany’s Federal Risk Assessment Institute (BfR), came to the opposite conclusion that glyphosate was “unlikely” to cause cancer to humans.

A war of words started with, notably, EFSA’s director calling scientists critical of its work (including some involved in IARC’s review) “facebook scientists” for a petition they had sent to the European Commission.

And it continues with, lately, directors of the two organisations engaging in a public exchange of letters, copied to more or less everyone politically involved on this file, where both defended the integrity of their respective institution’s work.

Eventually, a meeting between the two, meant to take place this week, was cancelled, as EFSA did not agree to the IARC’s director’s requests to change a number of its statements about IARC’s work on its website.

Under the giant shadow of Monsanto

One reason behind this almighty mess is the extreme public sensitivity of the topic: behind glyphosate lurks the shadow of US multinational Monsanto, currently one of the most hated companies on the planet, which built its economic development around this wide-spectrum herbicide and GM crops engineered to tolerate it. Monsanto coordinated industry producers into a Glyphosate Task Force (GTF) to facilitate the pesticide’s review approval.

But the story has more to it than a political tussle. While conflicts are common in science too, resolving them relies on scientists reviewing and debating the evidence. The problem is this step cannot be taken because parts of this evidence are missing.

Three industry-sponsored carcinogenicity studies on mice, in particular, are not accessible to IARC while EFSA insists they played an important role in informing its decision. This situation is unfortunately typical of debates on pesticides regulation. This is why for years Corporate Europe Observatory and others have been asking EFSA and the European Commission that, just as with clinical trials for medicines, the data supporting EFSA’s scientific opinions should systematically be made public to enable free scientific scrutiny.

To find out more about the basis of the glyphosate decision we filed an access to documents request to EFSA in December 2015 to demand the disclosure of these three mouse studies. EFSA refused, and justified this on the basis that the owners of the studies, all industry producers of glyphosate, said disclosing this evidence would undermine trade secrets and intellectual property rights. Corporate Europe Observatory is appealing that decision by EFSA.

Meanwhile, the political process goes on, with the European Commission expected (according to EU sources) to propose member states start discussing a new EU-wide renewal of glyphosate’s market authorisation next 7th or 8th March.

Adding to the tension, France’s food safety agency ANSES published on 12 February an opinion contradicting EFSA’s (even though ANSES officials had contributed to it) by saying that glyphosate could perhaps, after all, be classified as a substance suspected of being carcinogenic to humans – a category which would not imply an EU ban – and that more research should be done, in particular by the European Chemicals Agency (ECHA) in Helsinki.

The ‘mysterious three’

The starkest difference between the EU’s regulatory agencies and the independent scientists who wrote IARC’s assessment perhaps lies in their respective interpretation of the animal evidence.

The conflict is particularly intense over the EU’s use of five industry-sponsored carcinogenicity studies in mice reviewed by BfR and EFSA. Two of these studies, from 1983 (‘A chronic feeding study of glyphosate (Roundup technical) in mice 77-2061! (BDN-77-420)’) and 1993 (‘Glyphosate: 104-week dietary carcinogenicity study in mice, IRI 438618’), were already included in industry’s first EU level request for a market authorisation for glyphosate.

But industry sent three new unpublished studies for the EU market authorisation renewal – the ‘mysterious three’, as scientific literature reviews specialist Paul Whaley dubbed them):

• ‘Carcinogenicity Study with Glyphosate Technical in Swiss Albino Mice’ (2001), following OECD Guideline 451 & GLP – study owned by the Israeli pesticides company ADAMA Agan Ltd and was never published;
• ‘Glyphosate technical: Dietary Carcinogenicity Study in the Mouse’ (2009), following OECD Guideline 451 & GLP – study owned by the Australian pesticides company Nufarm and was never published;
• ‘HR-001: 18-Month Oral Oncogenicity Study in Mice’ (1997), following following OECD Guideline 451 & GLP – study owned by the Japanese pesticides company Arysta LifeSciences Corporation and was never published.

One study, two very different interpretations

The names of the authors of all five studies are redacted in EFSA’s publications. In a Twitter exchange on the matter, Monsanto Europe explained this was for security reasons: “If you get scientists’ names what’s stopping people going after them/families?”

The company later added to its first reply saying: “It’s a sad fact that some activists target Monsanto employees for harassment.” But this seems simply irrelevant in this case given that not a single Monsanto employee seems to have been involved in the conduct of these studies.

Despite the first two studies, from 1983 and 1993, also not having been published, IARC could access them. Indeed it interpreted the 1983 study as showing “a significant increase in the incidence of rare tumours, with a dose-related trend, which could be attributed to glyphosate.”

That makes a stark contrast with EFSA and BfR’s review of the same study. IARC’s interpretation of the 1993 study is on the other hand consistent with EFSA and BfR’s. But it could not evaluate the three more recent studies, even though it was able to access summaries which its scientists commented showed incidence of various tumours.

‘Key’ and ‘pivotal’ evidence

The Mysterious Three are an essential element of the conflict. This is particularly so because EFSA heavily referred to them to explain its assessment, with José Tarazona, the Head of EFSA’s Pesticides Unit in charge of the assessment, calling them “key” and “pivotal”.

Similar comments can be found from various member states’ experts, with Belgium insisting that “it was unfortunate that IARC did not take into account 3 guideline studies in both mice and rats, since this could have put the overall conclusions in another perspective.” This very unfair sentiment – IARC could not access these studies – was echoed by Ireland: “IARC’s failure to evaluate the 3 other studies is not helpful.”

Since EFSA’s publication, the agency has been arguing that there is enough detailed information in its documentation to perform a good analysis, but IARC scientists respond that the descriptions and summaries published miss key elements and cannot replace original data.

Among these missing elements, IARC said, are “the historical control data from the reporting laboratory for all tumours with statistically significant positive increases, by either test recommended by OECD; another is the survival of the animals.” More generally, IARC pointed to its list of attention points for all studies it assesses.

Secret perfection or convenient argument?

So what is in these Mysterious Three? How can only three studies explain such a striking contrast? Would they be so strong as to convince IARC to reverse its stance? Would they on the contrary confirm it?

Or, given the strong political interest in this file and the fact that the EU’s Pesticides Regulation would force glyphosate out of the market were its cancer-causing properties confirmed, isn’t referring to these secret studies a convenient argument for all those willing to keep glyphosate on the EU market anyway?

In its response to Corporate Europe Observatory on 5th February 2015 explaining why it would not release the information, EFSA said that the studies’ owners (who, by law, must be consulted) refused any disclosure because they considered their studies to contain trade secrets and intellectual property which if released would harm their industrial and commercial interests as well as their “competitive position”.

EFSA agreed with this analysis and explained that, according to the exception foreseen in the EU’s Public Access to Documents Regulation 1049/2001 as well as in the EU’s Pesticides Regulation 1107/2009, it was entitled to not disclose the documents.

Abusive use of the trade secrets protection argument

However, both regulations only protect commercial interests and, in the case of the Pesticides Regulation, a limited list of elements within the studies, not the whole document – it is difficult to believe that everything in a scientific study would be a trade secret.

Moreover, the EU’s Pesticides Regulation stipulates that any data owner refusing disclosure of its material must provide a verifiable proof that disclosure would harm him, which was apparently not done.

Finally, glyphosate has been off-patent for 15 years and most pesticide companies now producing glyphosate belong to the Monsanto-led Glyphosate Task Force, the group that bundled all these studies together and sent them to the BfR and EFSA. How would disclosing these studies harm any of these companies’ competitive position if they were already shared among the main competitors?

As a consequence, CEO is appealing this decision, hoping that EFSA will use the opportunity of this major file and controversy to demonstrate its good faith in actually acting upon its declared intentions on data transparency and providing a level of openness that enables this conflict to evolve into a more productive, evidence-based discussion.

David vs. Goliath legal action in play since 2011

The data used by the European Commission to grant a market authorisation to glyphosate has been a much-debated issue for a long time.

In October 2011 Greenpeace Netherlands and Pesticides Action Network Europe took action against the European Commission and at the European Court of Justice to compel it to disclose the glyphosate industry’s secret dossier. In October 2013 the Court’s General Court ordered the European Commission to disclose large sections of the documents.

But the European Commission lodged an appeal which is ongoing. From March 2015 onwards, the European Commission has received support from numerous industry groups in this appeal:

• the European Crop Protection Association (‘ECPA’), which argues that “an adequate protection of confidential business information (‘CBI’) is essential in order to preserve and stimulate innovation and thus competitiveness and growth in the EU crop protection sector.”
• CropLife International, the international lobby group of the pesticides industry, whose members “account for approximately 75% of sales across the crop protection industry worldwide” and whose interest consists in “promoting the interests of its members as regards, inter alia, the protection of intellectual property and, in particular, confidential business information.”
• A delegation of US industry, composed of CropLife America, Inc., the National Association of Manufacturers of the United States of America and the American Chemistry Council, Inc., who argue that “the present appeal, since it concerns a conflict between the right of access to documents concerning the environment and the protection of confidential business information that manufacturers of chemical products are required to submit to the competent authority, raises a question of principle which is liable to affect the interests of [their] members.”
• the European Chemical Industry Council, the EU’s chemicals industry, arguing that “it has for many years underlined the importance of an adequate protection of confidential business information (‘CBI’) for the competitiveness of the EU chemicals industry.”
• the European Crop Care Association, an association representing small and medium-sized enterprises operating in the generic pesticides industry, who says that “the Court’s judgment in the present appeal will have a significant impact on the small and medium-sized enterprises which it represents, which rely heavily on industrial secrets to protect their intellectual property and innovation.”

MEPs – reject the ‘Trade Secrets Directive’!

As an important aside, CEO also calls MEPs to reject the so-called Trade Secrets Directive, whose final vote in the European Parliament is announced for next April 12.

As a matter of fact, one of the numerous problems with this text is that it would give companies additional arguments to fight public interest disclosures in court by threatening public authorities with massive financial penalties would they dare to disclose information they consider a trade secret.

This article was originally published by Corporate Europe Observatory. Please refer to the original version for full list of references etc.

The practice of EU Commission health service SANTE to approve pesticides while important safety data are missing – the so-called ‘confirmatory data procedure’ (CDP) – has been judged a case of official ‘maladministration’.

This is the verdict of the EU Ombudsman, Emily O’Reilly, in a decision published today following a complaint by Pesticides Action Network (PAN) Europe.

The Commission’ s reliance on CDPs “was not compatible” with the provisions of Directive 91/414, she wrote, and “its use of CDPs appeared to constitute maladministration.”

And she makes clear that the Commission must adopt a far more precautionary approach with is pesticide approvals:

“Bearing in mind that any possible error in the Commissionʹs assessment based on insufficient data may cause serious, possibly irreversible harm to human health, the health of animals or to the environment in general … the CDP needs to be applied with particular caution and restraint.”

Hans Muilerman, PAN Europe’s chemicals coordinator, commented: “It is clear that DG SANTE and the member states let the interests of industry and farmers prevail over the interests of the public in allowing harmful pesticides on the market with data gaps and high risks.

“This structural violation of the rules implies that the pesticides currently on the market are not safe.”

Twisting and bending the rules

In 2012 PAN Europe published a report entitled ‘Twisting and bending the rule: In ‘Resubmission’ all efforts are aimed to get pesticides approved‘ which argued that in numerous cases, the Commission had approved active substances for pesticides where the legal requirements are not met.

In particular the report highlighted cases where there was insufficient data to justify excluding risks for human health, animal health, groundwater and the environment.

Under general EU legislation, active ingredients are added to an approved list once industry has submitted a dossier to show that they are safe and effective. Only once an active ingredient is registered can a pesticide product then be registered using that chemical. (Note: this is done by Member States, rather than at the EU level.)

Under the ‘Resubmission’ rule, however, active ingredients can be added which have failed the first round of safety checks. In 2012, there were 87 substances which had been applied for under this ruling, many of which had unknown – but potentially high – risk to people and the environment.

Under the previous pesticide Directive (91/414) O’Reilly considers use of these practices by DG SANTE as “unlawful”.

Meanwhile the new Regulation (1107/2009) should only allow the use of CDP in “exceptional cases” – and she concludes the use was not restricted as it should have been. Possible consequences for human health would be particularly worrying, writes the Ombudsman.

Several other shortcomings in the pesticide decisions were observed by the Ombudsman such as a lack of requirements to protect the environment, a lack of systematic verification of protective measures and even cases of approval when no safe use was demonstrated by Food Authority EFSA.

A potential cover up in the process

In the PAN Europe report, it was demonstrated that the CDP procedure was used as standard practice as 22 out of 25 recent approvals were based on this procedure. The Ombudsman now concludes that these practices were unlawful and currently not restricted as legally required.

She concludes that “Commission may be too lenient in its practices and might not be taken sufficiently account of the precautionary principle” and states that the priority should be requesting and assessing all required data before a decision is taken.

Even when Food Authority EFSA calculated high risks based on the available scientific evidence, DG SANTE in several cases approved the pesticide.

The Ombudsman writes that it is “difficult to understand how the Commission could legitimately decide … that these substances have no harmful effect or no unacceptable influence on the environment” and that a “satisfactory explanation has not been provided by Commission”.

In their reports and decisions DG SANTE tries to hide the (high) risks and data gaps observed by EFSA and claims that the pesticides are safe, according to O’Reilly.

She writes that she “could understand the complainant’s impression that the Commission’s review reports and approval decisions are ‘misleading’ and inaccurate” after identifying that the Commission had adopted misleading review reports and decisions through the process of Resubmission.

Commission ordered to change its practices

The solution proposed by the Ombudsman includes a change of practices by DG SANTE; the Ombudsman orders SANTE to prove in a report, to be published in two years’ time, that they have actually implemented the changes.

The confirmatory data procedure (CDP) was an invention of DG SANCO when industry was reluctant to present the obligatory safety data for their pesticides. With this CDP, pesticides could be approved with serious data gaps and with high risks, allowing industry to submit additional information only in future.

Vanessa Amaral-Rogers is a freelance journalist writing mainly on environmental themes.

Principal source: Pesticides Action Network Europe.

Also on The Ecologist:

• ‘Disgraceful ‘Honour’ for failing to protect people from poisons‘ by Georgina Downs
• ‘Thank you Greens! Now other parties too must keep us safe from pesticides‘ by Georgina Downs
• ‘UK fights EU attempts to bring in stricter rules on pesticide and crop spraying‘ by Alistair Driver
• ‘Negligent and unlawful: EFSA’s latest guidance on pesticide use and exposure‘ by Georgina Downs

In March 2015 the World Health Organisation’s International Agency for Research against Cancer (IARC) found the world’s most commonly used herbicide, glyphosate, “probably carcinogenic to humans”.

Three months later the EU’s official risk assessment of the pesticide, conducted by the European Food Safety Authority (EFSA) and Germany’s Federal Risk Assessment Institute (BfR), came to the opposite conclusion that glyphosate was “unlikely” to cause cancer to humans.

A war of words started with, notably, EFSA’s director calling scientists critical of its work (including some involved in IARC’s review) “facebook scientists” for a petition they had sent to the European Commission.

And it continues with, lately, directors of the two organisations engaging in a public exchange of letters, copied to more or less everyone politically involved on this file, where both defended the integrity of their respective institution’s work.

Eventually, a meeting between the two, meant to take place this week, was cancelled, as EFSA did not agree to the IARC’s director’s requests to change a number of its statements about IARC’s work on its website.

Under the giant shadow of Monsanto

One reason behind this almighty mess is the extreme public sensitivity of the topic: behind glyphosate lurks the shadow of US multinational Monsanto, currently one of the most hated companies on the planet, which built its economic development around this wide-spectrum herbicide and GM crops engineered to tolerate it. Monsanto coordinated industry producers into a Glyphosate Task Force (GTF) to facilitate the pesticide’s review approval.

But the story has more to it than a political tussle. While conflicts are common in science too, resolving them relies on scientists reviewing and debating the evidence. The problem is this step cannot be taken because parts of this evidence are missing.

Three industry-sponsored carcinogenicity studies on mice, in particular, are not accessible to IARC while EFSA insists they played an important role in informing its decision. This situation is unfortunately typical of debates on pesticides regulation. This is why for years Corporate Europe Observatory and others have been asking EFSA and the European Commission that, just as with clinical trials for medicines, the data supporting EFSA’s scientific opinions should systematically be made public to enable free scientific scrutiny.

To find out more about the basis of the glyphosate decision we filed an access to documents request to EFSA in December 2015 to demand the disclosure of these three mouse studies. EFSA refused, and justified this on the basis that the owners of the studies, all industry producers of glyphosate, said disclosing this evidence would undermine trade secrets and intellectual property rights. Corporate Europe Observatory is appealing that decision by EFSA.

Meanwhile, the political process goes on, with the European Commission expected (according to EU sources) to propose member states start discussing a new EU-wide renewal of glyphosate’s market authorisation next 7th or 8th March.

Adding to the tension, France’s food safety agency ANSES published on 12 February an opinion contradicting EFSA’s (even though ANSES officials had contributed to it) by saying that glyphosate could perhaps, after all, be classified as a substance suspected of being carcinogenic to humans – a category which would not imply an EU ban – and that more research should be done, in particular by the European Chemicals Agency (ECHA) in Helsinki.

The ‘mysterious three’

The starkest difference between the EU’s regulatory agencies and the independent scientists who wrote IARC’s assessment perhaps lies in their respective interpretation of the animal evidence.

The conflict is particularly intense over the EU’s use of five industry-sponsored carcinogenicity studies in mice reviewed by BfR and EFSA. Two of these studies, from 1983 (‘A chronic feeding study of glyphosate (Roundup technical) in mice 77-2061! (BDN-77-420)’) and 1993 (‘Glyphosate: 104-week dietary carcinogenicity study in mice, IRI 438618’), were already included in industry’s first EU level request for a market authorisation for glyphosate.

But industry sent three new unpublished studies for the EU market authorisation renewal – the ‘mysterious three’, as scientific literature reviews specialist Paul Whaley dubbed them):

• ‘Carcinogenicity Study with Glyphosate Technical in Swiss Albino Mice’ (2001), following OECD Guideline 451 & GLP – study owned by the Israeli pesticides company ADAMA Agan Ltd and was never published;
• ‘Glyphosate technical: Dietary Carcinogenicity Study in the Mouse’ (2009), following OECD Guideline 451 & GLP – study owned by the Australian pesticides company Nufarm and was never published;
• ‘HR-001: 18-Month Oral Oncogenicity Study in Mice’ (1997), following following OECD Guideline 451 & GLP – study owned by the Japanese pesticides company Arysta LifeSciences Corporation and was never published.

One study, two very different interpretations

The names of the authors of all five studies are redacted in EFSA’s publications. In a Twitter exchange on the matter, Monsanto Europe explained this was for security reasons: “If you get scientists’ names what’s stopping people going after them/families?”

The company later added to its first reply saying: “It’s a sad fact that some activists target Monsanto employees for harassment.” But this seems simply irrelevant in this case given that not a single Monsanto employee seems to have been involved in the conduct of these studies.

Despite the first two studies, from 1983 and 1993, also not having been published, IARC could access them. Indeed it interpreted the 1983 study as showing “a significant increase in the incidence of rare tumours, with a dose-related trend, which could be attributed to glyphosate.”

That makes a stark contrast with EFSA and BfR’s review of the same study. IARC’s interpretation of the 1993 study is on the other hand consistent with EFSA and BfR’s. But it could not evaluate the three more recent studies, even though it was able to access summaries which its scientists commented showed incidence of various tumours.

‘Key’ and ‘pivotal’ evidence

The Mysterious Three are an essential element of the conflict. This is particularly so because EFSA heavily referred to them to explain its assessment, with José Tarazona, the Head of EFSA’s Pesticides Unit in charge of the assessment, calling them “key” and “pivotal”.

Similar comments can be found from various member states’ experts, with Belgium insisting that “it was unfortunate that IARC did not take into account 3 guideline studies in both mice and rats, since this could have put the overall conclusions in another perspective.” This very unfair sentiment – IARC could not access these studies – was echoed by Ireland: “IARC’s failure to evaluate the 3 other studies is not helpful.”

Since EFSA’s publication, the agency has been arguing that there is enough detailed information in its documentation to perform a good analysis, but IARC scientists respond that the descriptions and summaries published miss key elements and cannot replace original data.

Among these missing elements, IARC said, are “the historical control data from the reporting laboratory for all tumours with statistically significant positive increases, by either test recommended by OECD; another is the survival of the animals.” More generally, IARC pointed to its list of attention points for all studies it assesses.

Secret perfection or convenient argument?

So what is in these Mysterious Three? How can only three studies explain such a striking contrast? Would they be so strong as to convince IARC to reverse its stance? Would they on the contrary confirm it?

Or, given the strong political interest in this file and the fact that the EU’s Pesticides Regulation would force glyphosate out of the market were its cancer-causing properties confirmed, isn’t referring to these secret studies a convenient argument for all those willing to keep glyphosate on the EU market anyway?

In its response to Corporate Europe Observatory on 5th February 2015 explaining why it would not release the information, EFSA said that the studies’ owners (who, by law, must be consulted) refused any disclosure because they considered their studies to contain trade secrets and intellectual property which if released would harm their industrial and commercial interests as well as their “competitive position”.

EFSA agreed with this analysis and explained that, according to the exception foreseen in the EU’s Public Access to Documents Regulation 1049/2001 as well as in the EU’s Pesticides Regulation 1107/2009, it was entitled to not disclose the documents.

Abusive use of the trade secrets protection argument

However, both regulations only protect commercial interests and, in the case of the Pesticides Regulation, a limited list of elements within the studies, not the whole document – it is difficult to believe that everything in a scientific study would be a trade secret.

Moreover, the EU’s Pesticides Regulation stipulates that any data owner refusing disclosure of its material must provide a verifiable proof that disclosure would harm him, which was apparently not done.

Finally, glyphosate has been off-patent for 15 years and most pesticide companies now producing glyphosate belong to the Monsanto-led Glyphosate Task Force, the group that bundled all these studies together and sent them to the BfR and EFSA. How would disclosing these studies harm any of these companies’ competitive position if they were already shared among the main competitors?

As a consequence, CEO is appealing this decision, hoping that EFSA will use the opportunity of this major file and controversy to demonstrate its good faith in actually acting upon its declared intentions on data transparency and providing a level of openness that enables this conflict to evolve into a more productive, evidence-based discussion.

David vs. Goliath legal action in play since 2011

The data used by the European Commission to grant a market authorisation to glyphosate has been a much-debated issue for a long time.

In October 2011 Greenpeace Netherlands and Pesticides Action Network Europe took action against the European Commission and at the European Court of Justice to compel it to disclose the glyphosate industry’s secret dossier. In October 2013 the Court’s General Court ordered the European Commission to disclose large sections of the documents.

But the European Commission lodged an appeal which is ongoing. From March 2015 onwards, the European Commission has received support from numerous industry groups in this appeal:

• the European Crop Protection Association (‘ECPA’), which argues that “an adequate protection of confidential business information (‘CBI’) is essential in order to preserve and stimulate innovation and thus competitiveness and growth in the EU crop protection sector.”
• CropLife International, the international lobby group of the pesticides industry, whose members “account for approximately 75% of sales across the crop protection industry worldwide” and whose interest consists in “promoting the interests of its members as regards, inter alia, the protection of intellectual property and, in particular, confidential business information.”
• A delegation of US industry, composed of CropLife America, Inc., the National Association of Manufacturers of the United States of America and the American Chemistry Council, Inc., who argue that “the present appeal, since it concerns a conflict between the right of access to documents concerning the environment and the protection of confidential business information that manufacturers of chemical products are required to submit to the competent authority, raises a question of principle which is liable to affect the interests of [their] members.”
• the European Chemical Industry Council, the EU’s chemicals industry, arguing that “it has for many years underlined the importance of an adequate protection of confidential business information (‘CBI’) for the competitiveness of the EU chemicals industry.”
• the European Crop Care Association, an association representing small and medium-sized enterprises operating in the generic pesticides industry, who says that “the Court’s judgment in the present appeal will have a significant impact on the small and medium-sized enterprises which it represents, which rely heavily on industrial secrets to protect their intellectual property and innovation.”

MEPs – reject the ‘Trade Secrets Directive’!

As an important aside, CEO also calls MEPs to reject the so-called Trade Secrets Directive, whose final vote in the European Parliament is announced for next April 12.

As a matter of fact, one of the numerous problems with this text is that it would give companies additional arguments to fight public interest disclosures in court by threatening public authorities with massive financial penalties would they dare to disclose information they consider a trade secret.

This article was originally published by Corporate Europe Observatory. Please refer to the original version for full list of references etc.

The practice of EU Commission health service SANTE to approve pesticides while important safety data are missing – the so-called ‘confirmatory data procedure’ (CDP) – has been judged a case of official ‘maladministration’.

This is the verdict of the EU Ombudsman, Emily O’Reilly, in a decision published today following a complaint by Pesticides Action Network (PAN) Europe.

The Commission’ s reliance on CDPs “was not compatible” with the provisions of Directive 91/414, she wrote, and “its use of CDPs appeared to constitute maladministration.”

And she makes clear that the Commission must adopt a far more precautionary approach with is pesticide approvals:

“Bearing in mind that any possible error in the Commissionʹs assessment based on insufficient data may cause serious, possibly irreversible harm to human health, the health of animals or to the environment in general … the CDP needs to be applied with particular caution and restraint.”

Hans Muilerman, PAN Europe’s chemicals coordinator, commented: “It is clear that DG SANTE and the member states let the interests of industry and farmers prevail over the interests of the public in allowing harmful pesticides on the market with data gaps and high risks.

“This structural violation of the rules implies that the pesticides currently on the market are not safe.”

Twisting and bending the rules

In 2012 PAN Europe published a report entitled ‘Twisting and bending the rule: In ‘Resubmission’ all efforts are aimed to get pesticides approved‘ which argued that in numerous cases, the Commission had approved active substances for pesticides where the legal requirements are not met.

In particular the report highlighted cases where there was insufficient data to justify excluding risks for human health, animal health, groundwater and the environment.

Under general EU legislation, active ingredients are added to an approved list once industry has submitted a dossier to show that they are safe and effective. Only once an active ingredient is registered can a pesticide product then be registered using that chemical. (Note: this is done by Member States, rather than at the EU level.)

Under the ‘Resubmission’ rule, however, active ingredients can be added which have failed the first round of safety checks. In 2012, there were 87 substances which had been applied for under this ruling, many of which had unknown – but potentially high – risk to people and the environment.

Under the previous pesticide Directive (91/414) O’Reilly considers use of these practices by DG SANTE as “unlawful”.

Meanwhile the new Regulation (1107/2009) should only allow the use of CDP in “exceptional cases” – and she concludes the use was not restricted as it should have been. Possible consequences for human health would be particularly worrying, writes the Ombudsman.

Several other shortcomings in the pesticide decisions were observed by the Ombudsman such as a lack of requirements to protect the environment, a lack of systematic verification of protective measures and even cases of approval when no safe use was demonstrated by Food Authority EFSA.

A potential cover up in the process

In the PAN Europe report, it was demonstrated that the CDP procedure was used as standard practice as 22 out of 25 recent approvals were based on this procedure. The Ombudsman now concludes that these practices were unlawful and currently not restricted as legally required.

She concludes that “Commission may be too lenient in its practices and might not be taken sufficiently account of the precautionary principle” and states that the priority should be requesting and assessing all required data before a decision is taken.

Even when Food Authority EFSA calculated high risks based on the available scientific evidence, DG SANTE in several cases approved the pesticide.

The Ombudsman writes that it is “difficult to understand how the Commission could legitimately decide … that these substances have no harmful effect or no unacceptable influence on the environment” and that a “satisfactory explanation has not been provided by Commission”.

In their reports and decisions DG SANTE tries to hide the (high) risks and data gaps observed by EFSA and claims that the pesticides are safe, according to O’Reilly.

She writes that she “could understand the complainant’s impression that the Commission’s review reports and approval decisions are ‘misleading’ and inaccurate” after identifying that the Commission had adopted misleading review reports and decisions through the process of Resubmission.

Commission ordered to change its practices

The solution proposed by the Ombudsman includes a change of practices by DG SANTE; the Ombudsman orders SANTE to prove in a report, to be published in two years’ time, that they have actually implemented the changes.

The confirmatory data procedure (CDP) was an invention of DG SANCO when industry was reluctant to present the obligatory safety data for their pesticides. With this CDP, pesticides could be approved with serious data gaps and with high risks, allowing industry to submit additional information only in future.

Vanessa Amaral-Rogers is a freelance journalist writing mainly on environmental themes.

Principal source: Pesticides Action Network Europe.

Also on The Ecologist:

• ‘Disgraceful ‘Honour’ for failing to protect people from poisons‘ by Georgina Downs
• ‘Thank you Greens! Now other parties too must keep us safe from pesticides‘ by Georgina Downs
• ‘UK fights EU attempts to bring in stricter rules on pesticide and crop spraying‘ by Alistair Driver
• ‘Negligent and unlawful: EFSA’s latest guidance on pesticide use and exposure‘ by Georgina Downs

In March 2015 the World Health Organisation’s International Agency for Research against Cancer (IARC) found the world’s most commonly used herbicide, glyphosate, “probably carcinogenic to humans”.

Three months later the EU’s official risk assessment of the pesticide, conducted by the European Food Safety Authority (EFSA) and Germany’s Federal Risk Assessment Institute (BfR), came to the opposite conclusion that glyphosate was “unlikely” to cause cancer to humans.

A war of words started with, notably, EFSA’s director calling scientists critical of its work (including some involved in IARC’s review) “facebook scientists” for a petition they had sent to the European Commission.

And it continues with, lately, directors of the two organisations engaging in a public exchange of letters, copied to more or less everyone politically involved on this file, where both defended the integrity of their respective institution’s work.

Eventually, a meeting between the two, meant to take place this week, was cancelled, as EFSA did not agree to the IARC’s director’s requests to change a number of its statements about IARC’s work on its website.

Under the giant shadow of Monsanto

One reason behind this almighty mess is the extreme public sensitivity of the topic: behind glyphosate lurks the shadow of US multinational Monsanto, currently one of the most hated companies on the planet, which built its economic development around this wide-spectrum herbicide and GM crops engineered to tolerate it. Monsanto coordinated industry producers into a Glyphosate Task Force (GTF) to facilitate the pesticide’s review approval.

But the story has more to it than a political tussle. While conflicts are common in science too, resolving them relies on scientists reviewing and debating the evidence. The problem is this step cannot be taken because parts of this evidence are missing.

Three industry-sponsored carcinogenicity studies on mice, in particular, are not accessible to IARC while EFSA insists they played an important role in informing its decision. This situation is unfortunately typical of debates on pesticides regulation. This is why for years Corporate Europe Observatory and others have been asking EFSA and the European Commission that, just as with clinical trials for medicines, the data supporting EFSA’s scientific opinions should systematically be made public to enable free scientific scrutiny.

To find out more about the basis of the glyphosate decision we filed an access to documents request to EFSA in December 2015 to demand the disclosure of these three mouse studies. EFSA refused, and justified this on the basis that the owners of the studies, all industry producers of glyphosate, said disclosing this evidence would undermine trade secrets and intellectual property rights. Corporate Europe Observatory is appealing that decision by EFSA.

Meanwhile, the political process goes on, with the European Commission expected (according to EU sources) to propose member states start discussing a new EU-wide renewal of glyphosate’s market authorisation next 7th or 8th March.

Adding to the tension, France’s food safety agency ANSES published on 12 February an opinion contradicting EFSA’s (even though ANSES officials had contributed to it) by saying that glyphosate could perhaps, after all, be classified as a substance suspected of being carcinogenic to humans – a category which would not imply an EU ban – and that more research should be done, in particular by the European Chemicals Agency (ECHA) in Helsinki.

The ‘mysterious three’

The starkest difference between the EU’s regulatory agencies and the independent scientists who wrote IARC’s assessment perhaps lies in their respective interpretation of the animal evidence.

The conflict is particularly intense over the EU’s use of five industry-sponsored carcinogenicity studies in mice reviewed by BfR and EFSA. Two of these studies, from 1983 (‘A chronic feeding study of glyphosate (Roundup technical) in mice 77-2061! (BDN-77-420)’) and 1993 (‘Glyphosate: 104-week dietary carcinogenicity study in mice, IRI 438618’), were already included in industry’s first EU level request for a market authorisation for glyphosate.

But industry sent three new unpublished studies for the EU market authorisation renewal – the ‘mysterious three’, as scientific literature reviews specialist Paul Whaley dubbed them):

• ‘Carcinogenicity Study with Glyphosate Technical in Swiss Albino Mice’ (2001), following OECD Guideline 451 & GLP – study owned by the Israeli pesticides company ADAMA Agan Ltd and was never published;
• ‘Glyphosate technical: Dietary Carcinogenicity Study in the Mouse’ (2009), following OECD Guideline 451 & GLP – study owned by the Australian pesticides company Nufarm and was never published;
• ‘HR-001: 18-Month Oral Oncogenicity Study in Mice’ (1997), following following OECD Guideline 451 & GLP – study owned by the Japanese pesticides company Arysta LifeSciences Corporation and was never published.

One study, two very different interpretations

The names of the authors of all five studies are redacted in EFSA’s publications. In a Twitter exchange on the matter, Monsanto Europe explained this was for security reasons: “If you get scientists’ names what’s stopping people going after them/families?”

The company later added to its first reply saying: “It’s a sad fact that some activists target Monsanto employees for harassment.” But this seems simply irrelevant in this case given that not a single Monsanto employee seems to have been involved in the conduct of these studies.

Despite the first two studies, from 1983 and 1993, also not having been published, IARC could access them. Indeed it interpreted the 1983 study as showing “a significant increase in the incidence of rare tumours, with a dose-related trend, which could be attributed to glyphosate.”

That makes a stark contrast with EFSA and BfR’s review of the same study. IARC’s interpretation of the 1993 study is on the other hand consistent with EFSA and BfR’s. But it could not evaluate the three more recent studies, even though it was able to access summaries which its scientists commented showed incidence of various tumours.

‘Key’ and ‘pivotal’ evidence

The Mysterious Three are an essential element of the conflict. This is particularly so because EFSA heavily referred to them to explain its assessment, with José Tarazona, the Head of EFSA’s Pesticides Unit in charge of the assessment, calling them “key” and “pivotal”.

Similar comments can be found from various member states’ experts, with Belgium insisting that “it was unfortunate that IARC did not take into account 3 guideline studies in both mice and rats, since this could have put the overall conclusions in another perspective.” This very unfair sentiment – IARC could not access these studies – was echoed by Ireland: “IARC’s failure to evaluate the 3 other studies is not helpful.”

Since EFSA’s publication, the agency has been arguing that there is enough detailed information in its documentation to perform a good analysis, but IARC scientists respond that the descriptions and summaries published miss key elements and cannot replace original data.

Among these missing elements, IARC said, are “the historical control data from the reporting laboratory for all tumours with statistically significant positive increases, by either test recommended by OECD; another is the survival of the animals.” More generally, IARC pointed to its list of attention points for all studies it assesses.

Secret perfection or convenient argument?

So what is in these Mysterious Three? How can only three studies explain such a striking contrast? Would they be so strong as to convince IARC to reverse its stance? Would they on the contrary confirm it?

Or, given the strong political interest in this file and the fact that the EU’s Pesticides Regulation would force glyphosate out of the market were its cancer-causing properties confirmed, isn’t referring to these secret studies a convenient argument for all those willing to keep glyphosate on the EU market anyway?

In its response to Corporate Europe Observatory on 5th February 2015 explaining why it would not release the information, EFSA said that the studies’ owners (who, by law, must be consulted) refused any disclosure because they considered their studies to contain trade secrets and intellectual property which if released would harm their industrial and commercial interests as well as their “competitive position”.

EFSA agreed with this analysis and explained that, according to the exception foreseen in the EU’s Public Access to Documents Regulation 1049/2001 as well as in the EU’s Pesticides Regulation 1107/2009, it was entitled to not disclose the documents.

Abusive use of the trade secrets protection argument

However, both regulations only protect commercial interests and, in the case of the Pesticides Regulation, a limited list of elements within the studies, not the whole document – it is difficult to believe that everything in a scientific study would be a trade secret.

Moreover, the EU’s Pesticides Regulation stipulates that any data owner refusing disclosure of its material must provide a verifiable proof that disclosure would harm him, which was apparently not done.

Finally, glyphosate has been off-patent for 15 years and most pesticide companies now producing glyphosate belong to the Monsanto-led Glyphosate Task Force, the group that bundled all these studies together and sent them to the BfR and EFSA. How would disclosing these studies harm any of these companies’ competitive position if they were already shared among the main competitors?

As a consequence, CEO is appealing this decision, hoping that EFSA will use the opportunity of this major file and controversy to demonstrate its good faith in actually acting upon its declared intentions on data transparency and providing a level of openness that enables this conflict to evolve into a more productive, evidence-based discussion.

David vs. Goliath legal action in play since 2011

The data used by the European Commission to grant a market authorisation to glyphosate has been a much-debated issue for a long time.

In October 2011 Greenpeace Netherlands and Pesticides Action Network Europe took action against the European Commission and at the European Court of Justice to compel it to disclose the glyphosate industry’s secret dossier. In October 2013 the Court’s General Court ordered the European Commission to disclose large sections of the documents.

But the European Commission lodged an appeal which is ongoing. From March 2015 onwards, the European Commission has received support from numerous industry groups in this appeal:

• the European Crop Protection Association (‘ECPA’), which argues that “an adequate protection of confidential business information (‘CBI’) is essential in order to preserve and stimulate innovation and thus competitiveness and growth in the EU crop protection sector.”
• CropLife International, the international lobby group of the pesticides industry, whose members “account for approximately 75% of sales across the crop protection industry worldwide” and whose interest consists in “promoting the interests of its members as regards, inter alia, the protection of intellectual property and, in particular, confidential business information.”
• A delegation of US industry, composed of CropLife America, Inc., the National Association of Manufacturers of the United States of America and the American Chemistry Council, Inc., who argue that “the present appeal, since it concerns a conflict between the right of access to documents concerning the environment and the protection of confidential business information that manufacturers of chemical products are required to submit to the competent authority, raises a question of principle which is liable to affect the interests of [their] members.”
• the European Chemical Industry Council, the EU’s chemicals industry, arguing that “it has for many years underlined the importance of an adequate protection of confidential business information (‘CBI’) for the competitiveness of the EU chemicals industry.”
• the European Crop Care Association, an association representing small and medium-sized enterprises operating in the generic pesticides industry, who says that “the Court’s judgment in the present appeal will have a significant impact on the small and medium-sized enterprises which it represents, which rely heavily on industrial secrets to protect their intellectual property and innovation.”

MEPs – reject the ‘Trade Secrets Directive’!

As an important aside, CEO also calls MEPs to reject the so-called Trade Secrets Directive, whose final vote in the European Parliament is announced for next April 12.

As a matter of fact, one of the numerous problems with this text is that it would give companies additional arguments to fight public interest disclosures in court by threatening public authorities with massive financial penalties would they dare to disclose information they consider a trade secret.

This article was originally published by Corporate Europe Observatory. Please refer to the original version for full list of references etc.

The practice of EU Commission health service SANTE to approve pesticides while important safety data are missing – the so-called ‘confirmatory data procedure’ (CDP) – has been judged a case of official ‘maladministration’.

This is the verdict of the EU Ombudsman, Emily O’Reilly, in a decision published today following a complaint by Pesticides Action Network (PAN) Europe.

The Commission’ s reliance on CDPs “was not compatible” with the provisions of Directive 91/414, she wrote, and “its use of CDPs appeared to constitute maladministration.”

And she makes clear that the Commission must adopt a far more precautionary approach with is pesticide approvals:

“Bearing in mind that any possible error in the Commissionʹs assessment based on insufficient data may cause serious, possibly irreversible harm to human health, the health of animals or to the environment in general … the CDP needs to be applied with particular caution and restraint.”

Hans Muilerman, PAN Europe’s chemicals coordinator, commented: “It is clear that DG SANTE and the member states let the interests of industry and farmers prevail over the interests of the public in allowing harmful pesticides on the market with data gaps and high risks.

“This structural violation of the rules implies that the pesticides currently on the market are not safe.”

Twisting and bending the rules

In 2012 PAN Europe published a report entitled ‘Twisting and bending the rule: In ‘Resubmission’ all efforts are aimed to get pesticides approved‘ which argued that in numerous cases, the Commission had approved active substances for pesticides where the legal requirements are not met.

In particular the report highlighted cases where there was insufficient data to justify excluding risks for human health, animal health, groundwater and the environment.

Under general EU legislation, active ingredients are added to an approved list once industry has submitted a dossier to show that they are safe and effective. Only once an active ingredient is registered can a pesticide product then be registered using that chemical. (Note: this is done by Member States, rather than at the EU level.)

Under the ‘Resubmission’ rule, however, active ingredients can be added which have failed the first round of safety checks. In 2012, there were 87 substances which had been applied for under this ruling, many of which had unknown – but potentially high – risk to people and the environment.

Under the previous pesticide Directive (91/414) O’Reilly considers use of these practices by DG SANTE as “unlawful”.

Meanwhile the new Regulation (1107/2009) should only allow the use of CDP in “exceptional cases” – and she concludes the use was not restricted as it should have been. Possible consequences for human health would be particularly worrying, writes the Ombudsman.

Several other shortcomings in the pesticide decisions were observed by the Ombudsman such as a lack of requirements to protect the environment, a lack of systematic verification of protective measures and even cases of approval when no safe use was demonstrated by Food Authority EFSA.

A potential cover up in the process

In the PAN Europe report, it was demonstrated that the CDP procedure was used as standard practice as 22 out of 25 recent approvals were based on this procedure. The Ombudsman now concludes that these practices were unlawful and currently not restricted as legally required.

She concludes that “Commission may be too lenient in its practices and might not be taken sufficiently account of the precautionary principle” and states that the priority should be requesting and assessing all required data before a decision is taken.

Even when Food Authority EFSA calculated high risks based on the available scientific evidence, DG SANTE in several cases approved the pesticide.

The Ombudsman writes that it is “difficult to understand how the Commission could legitimately decide … that these substances have no harmful effect or no unacceptable influence on the environment” and that a “satisfactory explanation has not been provided by Commission”.

In their reports and decisions DG SANTE tries to hide the (high) risks and data gaps observed by EFSA and claims that the pesticides are safe, according to O’Reilly.

She writes that she “could understand the complainant’s impression that the Commission’s review reports and approval decisions are ‘misleading’ and inaccurate” after identifying that the Commission had adopted misleading review reports and decisions through the process of Resubmission.

Commission ordered to change its practices

The solution proposed by the Ombudsman includes a change of practices by DG SANTE; the Ombudsman orders SANTE to prove in a report, to be published in two years’ time, that they have actually implemented the changes.

The confirmatory data procedure (CDP) was an invention of DG SANCO when industry was reluctant to present the obligatory safety data for their pesticides. With this CDP, pesticides could be approved with serious data gaps and with high risks, allowing industry to submit additional information only in future.

Vanessa Amaral-Rogers is a freelance journalist writing mainly on environmental themes.

Principal source: Pesticides Action Network Europe.

Also on The Ecologist:

• ‘Disgraceful ‘Honour’ for failing to protect people from poisons‘ by Georgina Downs
• ‘Thank you Greens! Now other parties too must keep us safe from pesticides‘ by Georgina Downs
• ‘UK fights EU attempts to bring in stricter rules on pesticide and crop spraying‘ by Alistair Driver
• ‘Negligent and unlawful: EFSA’s latest guidance on pesticide use and exposure‘ by Georgina Downs

In March 2015 the World Health Organisation’s International Agency for Research against Cancer (IARC) found the world’s most commonly used herbicide, glyphosate, “probably carcinogenic to humans”.

Three months later the EU’s official risk assessment of the pesticide, conducted by the European Food Safety Authority (EFSA) and Germany’s Federal Risk Assessment Institute (BfR), came to the opposite conclusion that glyphosate was “unlikely” to cause cancer to humans.

A war of words started with, notably, EFSA’s director calling scientists critical of its work (including some involved in IARC’s review) “facebook scientists” for a petition they had sent to the European Commission.

And it continues with, lately, directors of the two organisations engaging in a public exchange of letters, copied to more or less everyone politically involved on this file, where both defended the integrity of their respective institution’s work.

Eventually, a meeting between the two, meant to take place this week, was cancelled, as EFSA did not agree to the IARC’s director’s requests to change a number of its statements about IARC’s work on its website.

Under the giant shadow of Monsanto

One reason behind this almighty mess is the extreme public sensitivity of the topic: behind glyphosate lurks the shadow of US multinational Monsanto, currently one of the most hated companies on the planet, which built its economic development around this wide-spectrum herbicide and GM crops engineered to tolerate it. Monsanto coordinated industry producers into a Glyphosate Task Force (GTF) to facilitate the pesticide’s review approval.

But the story has more to it than a political tussle. While conflicts are common in science too, resolving them relies on scientists reviewing and debating the evidence. The problem is this step cannot be taken because parts of this evidence are missing.

Three industry-sponsored carcinogenicity studies on mice, in particular, are not accessible to IARC while EFSA insists they played an important role in informing its decision. This situation is unfortunately typical of debates on pesticides regulation. This is why for years Corporate Europe Observatory and others have been asking EFSA and the European Commission that, just as with clinical trials for medicines, the data supporting EFSA’s scientific opinions should systematically be made public to enable free scientific scrutiny.

To find out more about the basis of the glyphosate decision we filed an access to documents request to EFSA in December 2015 to demand the disclosure of these three mouse studies. EFSA refused, and justified this on the basis that the owners of the studies, all industry producers of glyphosate, said disclosing this evidence would undermine trade secrets and intellectual property rights. Corporate Europe Observatory is appealing that decision by EFSA.

Meanwhile, the political process goes on, with the European Commission expected (according to EU sources) to propose member states start discussing a new EU-wide renewal of glyphosate’s market authorisation next 7th or 8th March.

Adding to the tension, France’s food safety agency ANSES published on 12 February an opinion contradicting EFSA’s (even though ANSES officials had contributed to it) by saying that glyphosate could perhaps, after all, be classified as a substance suspected of being carcinogenic to humans – a category which would not imply an EU ban – and that more research should be done, in particular by the European Chemicals Agency (ECHA) in Helsinki.

The ‘mysterious three’

The starkest difference between the EU’s regulatory agencies and the independent scientists who wrote IARC’s assessment perhaps lies in their respective interpretation of the animal evidence.

The conflict is particularly intense over the EU’s use of five industry-sponsored carcinogenicity studies in mice reviewed by BfR and EFSA. Two of these studies, from 1983 (‘A chronic feeding study of glyphosate (Roundup technical) in mice 77-2061! (BDN-77-420)’) and 1993 (‘Glyphosate: 104-week dietary carcinogenicity study in mice, IRI 438618’), were already included in industry’s first EU level request for a market authorisation for glyphosate.

But industry sent three new unpublished studies for the EU market authorisation renewal – the ‘mysterious three’, as scientific literature reviews specialist Paul Whaley dubbed them):

• ‘Carcinogenicity Study with Glyphosate Technical in Swiss Albino Mice’ (2001), following OECD Guideline 451 & GLP – study owned by the Israeli pesticides company ADAMA Agan Ltd and was never published;
• ‘Glyphosate technical: Dietary Carcinogenicity Study in the Mouse’ (2009), following OECD Guideline 451 & GLP – study owned by the Australian pesticides company Nufarm and was never published;
• ‘HR-001: 18-Month Oral Oncogenicity Study in Mice’ (1997), following following OECD Guideline 451 & GLP – study owned by the Japanese pesticides company Arysta LifeSciences Corporation and was never published.

One study, two very different interpretations

The names of the authors of all five studies are redacted in EFSA’s publications. In a Twitter exchange on the matter, Monsanto Europe explained this was for security reasons: “If you get scientists’ names what’s stopping people going after them/families?”

The company later added to its first reply saying: “It’s a sad fact that some activists target Monsanto employees for harassment.” But this seems simply irrelevant in this case given that not a single Monsanto employee seems to have been involved in the conduct of these studies.

Despite the first two studies, from 1983 and 1993, also not having been published, IARC could access them. Indeed it interpreted the 1983 study as showing “a significant increase in the incidence of rare tumours, with a dose-related trend, which could be attributed to glyphosate.”

That makes a stark contrast with EFSA and BfR’s review of the same study. IARC’s interpretation of the 1993 study is on the other hand consistent with EFSA and BfR’s. But it could not evaluate the three more recent studies, even though it was able to access summaries which its scientists commented showed incidence of various tumours.

‘Key’ and ‘pivotal’ evidence

The Mysterious Three are an essential element of the conflict. This is particularly so because EFSA heavily referred to them to explain its assessment, with José Tarazona, the Head of EFSA’s Pesticides Unit in charge of the assessment, calling them “key” and “pivotal”.

Similar comments can be found from various member states’ experts, with Belgium insisting that “it was unfortunate that IARC did not take into account 3 guideline studies in both mice and rats, since this could have put the overall conclusions in another perspective.” This very unfair sentiment – IARC could not access these studies – was echoed by Ireland: “IARC’s failure to evaluate the 3 other studies is not helpful.”

Since EFSA’s publication, the agency has been arguing that there is enough detailed information in its documentation to perform a good analysis, but IARC scientists respond that the descriptions and summaries published miss key elements and cannot replace original data.

Among these missing elements, IARC said, are “the historical control data from the reporting laboratory for all tumours with statistically significant positive increases, by either test recommended by OECD; another is the survival of the animals.” More generally, IARC pointed to its list of attention points for all studies it assesses.

Secret perfection or convenient argument?

So what is in these Mysterious Three? How can only three studies explain such a striking contrast? Would they be so strong as to convince IARC to reverse its stance? Would they on the contrary confirm it?

Or, given the strong political interest in this file and the fact that the EU’s Pesticides Regulation would force glyphosate out of the market were its cancer-causing properties confirmed, isn’t referring to these secret studies a convenient argument for all those willing to keep glyphosate on the EU market anyway?

In its response to Corporate Europe Observatory on 5th February 2015 explaining why it would not release the information, EFSA said that the studies’ owners (who, by law, must be consulted) refused any disclosure because they considered their studies to contain trade secrets and intellectual property which if released would harm their industrial and commercial interests as well as their “competitive position”.

EFSA agreed with this analysis and explained that, according to the exception foreseen in the EU’s Public Access to Documents Regulation 1049/2001 as well as in the EU’s Pesticides Regulation 1107/2009, it was entitled to not disclose the documents.

Abusive use of the trade secrets protection argument

However, both regulations only protect commercial interests and, in the case of the Pesticides Regulation, a limited list of elements within the studies, not the whole document – it is difficult to believe that everything in a scientific study would be a trade secret.

Moreover, the EU’s Pesticides Regulation stipulates that any data owner refusing disclosure of its material must provide a verifiable proof that disclosure would harm him, which was apparently not done.

Finally, glyphosate has been off-patent for 15 years and most pesticide companies now producing glyphosate belong to the Monsanto-led Glyphosate Task Force, the group that bundled all these studies together and sent them to the BfR and EFSA. How would disclosing these studies harm any of these companies’ competitive position if they were already shared among the main competitors?

As a consequence, CEO is appealing this decision, hoping that EFSA will use the opportunity of this major file and controversy to demonstrate its good faith in actually acting upon its declared intentions on data transparency and providing a level of openness that enables this conflict to evolve into a more productive, evidence-based discussion.

David vs. Goliath legal action in play since 2011

The data used by the European Commission to grant a market authorisation to glyphosate has been a much-debated issue for a long time.

In October 2011 Greenpeace Netherlands and Pesticides Action Network Europe took action against the European Commission and at the European Court of Justice to compel it to disclose the glyphosate industry’s secret dossier. In October 2013 the Court’s General Court ordered the European Commission to disclose large sections of the documents.

But the European Commission lodged an appeal which is ongoing. From March 2015 onwards, the European Commission has received support from numerous industry groups in this appeal:

• the European Crop Protection Association (‘ECPA’), which argues that “an adequate protection of confidential business information (‘CBI’) is essential in order to preserve and stimulate innovation and thus competitiveness and growth in the EU crop protection sector.”
• CropLife International, the international lobby group of the pesticides industry, whose members “account for approximately 75% of sales across the crop protection industry worldwide” and whose interest consists in “promoting the interests of its members as regards, inter alia, the protection of intellectual property and, in particular, confidential business information.”
• A delegation of US industry, composed of CropLife America, Inc., the National Association of Manufacturers of the United States of America and the American Chemistry Council, Inc., who argue that “the present appeal, since it concerns a conflict between the right of access to documents concerning the environment and the protection of confidential business information that manufacturers of chemical products are required to submit to the competent authority, raises a question of principle which is liable to affect the interests of [their] members.”
• the European Chemical Industry Council, the EU’s chemicals industry, arguing that “it has for many years underlined the importance of an adequate protection of confidential business information (‘CBI’) for the competitiveness of the EU chemicals industry.”
• the European Crop Care Association, an association representing small and medium-sized enterprises operating in the generic pesticides industry, who says that “the Court’s judgment in the present appeal will have a significant impact on the small and medium-sized enterprises which it represents, which rely heavily on industrial secrets to protect their intellectual property and innovation.”

MEPs – reject the ‘Trade Secrets Directive’!

As an important aside, CEO also calls MEPs to reject the so-called Trade Secrets Directive, whose final vote in the European Parliament is announced for next April 12.

As a matter of fact, one of the numerous problems with this text is that it would give companies additional arguments to fight public interest disclosures in court by threatening public authorities with massive financial penalties would they dare to disclose information they consider a trade secret.

This article was originally published by Corporate Europe Observatory. Please refer to the original version for full list of references etc.

The practice of EU Commission health service SANTE to approve pesticides while important safety data are missing – the so-called ‘confirmatory data procedure’ (CDP) – has been judged a case of official ‘maladministration’.

This is the verdict of the EU Ombudsman, Emily O’Reilly, in a decision published today following a complaint by Pesticides Action Network (PAN) Europe.

The Commission’ s reliance on CDPs “was not compatible” with the provisions of Directive 91/414, she wrote, and “its use of CDPs appeared to constitute maladministration.”

And she makes clear that the Commission must adopt a far more precautionary approach with is pesticide approvals:

“Bearing in mind that any possible error in the Commissionʹs assessment based on insufficient data may cause serious, possibly irreversible harm to human health, the health of animals or to the environment in general … the CDP needs to be applied with particular caution and restraint.”

Hans Muilerman, PAN Europe’s chemicals coordinator, commented: “It is clear that DG SANTE and the member states let the interests of industry and farmers prevail over the interests of the public in allowing harmful pesticides on the market with data gaps and high risks.

“This structural violation of the rules implies that the pesticides currently on the market are not safe.”

Twisting and bending the rules

In 2012 PAN Europe published a report entitled ‘Twisting and bending the rule: In ‘Resubmission’ all efforts are aimed to get pesticides approved‘ which argued that in numerous cases, the Commission had approved active substances for pesticides where the legal requirements are not met.

In particular the report highlighted cases where there was insufficient data to justify excluding risks for human health, animal health, groundwater and the environment.

Under general EU legislation, active ingredients are added to an approved list once industry has submitted a dossier to show that they are safe and effective. Only once an active ingredient is registered can a pesticide product then be registered using that chemical. (Note: this is done by Member States, rather than at the EU level.)

Under the ‘Resubmission’ rule, however, active ingredients can be added which have failed the first round of safety checks. In 2012, there were 87 substances which had been applied for under this ruling, many of which had unknown – but potentially high – risk to people and the environment.

Under the previous pesticide Directive (91/414) O’Reilly considers use of these practices by DG SANTE as “unlawful”.

Meanwhile the new Regulation (1107/2009) should only allow the use of CDP in “exceptional cases” – and she concludes the use was not restricted as it should have been. Possible consequences for human health would be particularly worrying, writes the Ombudsman.

Several other shortcomings in the pesticide decisions were observed by the Ombudsman such as a lack of requirements to protect the environment, a lack of systematic verification of protective measures and even cases of approval when no safe use was demonstrated by Food Authority EFSA.

A potential cover up in the process

In the PAN Europe report, it was demonstrated that the CDP procedure was used as standard practice as 22 out of 25 recent approvals were based on this procedure. The Ombudsman now concludes that these practices were unlawful and currently not restricted as legally required.

She concludes that “Commission may be too lenient in its practices and might not be taken sufficiently account of the precautionary principle” and states that the priority should be requesting and assessing all required data before a decision is taken.

Even when Food Authority EFSA calculated high risks based on the available scientific evidence, DG SANTE in several cases approved the pesticide.

The Ombudsman writes that it is “difficult to understand how the Commission could legitimately decide … that these substances have no harmful effect or no unacceptable influence on the environment” and that a “satisfactory explanation has not been provided by Commission”.

In their reports and decisions DG SANTE tries to hide the (high) risks and data gaps observed by EFSA and claims that the pesticides are safe, according to O’Reilly.

She writes that she “could understand the complainant’s impression that the Commission’s review reports and approval decisions are ‘misleading’ and inaccurate” after identifying that the Commission had adopted misleading review reports and decisions through the process of Resubmission.

Commission ordered to change its practices

The solution proposed by the Ombudsman includes a change of practices by DG SANTE; the Ombudsman orders SANTE to prove in a report, to be published in two years’ time, that they have actually implemented the changes.

The confirmatory data procedure (CDP) was an invention of DG SANCO when industry was reluctant to present the obligatory safety data for their pesticides. With this CDP, pesticides could be approved with serious data gaps and with high risks, allowing industry to submit additional information only in future.

Vanessa Amaral-Rogers is a freelance journalist writing mainly on environmental themes.

Principal source: Pesticides Action Network Europe.

Also on The Ecologist:

• ‘Disgraceful ‘Honour’ for failing to protect people from poisons‘ by Georgina Downs
• ‘Thank you Greens! Now other parties too must keep us safe from pesticides‘ by Georgina Downs
• ‘UK fights EU attempts to bring in stricter rules on pesticide and crop spraying‘ by Alistair Driver
• ‘Negligent and unlawful: EFSA’s latest guidance on pesticide use and exposure‘ by Georgina Downs

In March 2015 the World Health Organisation’s International Agency for Research against Cancer (IARC) found the world’s most commonly used herbicide, glyphosate, “probably carcinogenic to humans”.

Three months later the EU’s official risk assessment of the pesticide, conducted by the European Food Safety Authority (EFSA) and Germany’s Federal Risk Assessment Institute (BfR), came to the opposite conclusion that glyphosate was “unlikely” to cause cancer to humans.

A war of words started with, notably, EFSA’s director calling scientists critical of its work (including some involved in IARC’s review) “facebook scientists” for a petition they had sent to the European Commission.

And it continues with, lately, directors of the two organisations engaging in a public exchange of letters, copied to more or less everyone politically involved on this file, where both defended the integrity of their respective institution’s work.

Eventually, a meeting between the two, meant to take place this week, was cancelled, as EFSA did not agree to the IARC’s director’s requests to change a number of its statements about IARC’s work on its website.

Under the giant shadow of Monsanto

One reason behind this almighty mess is the extreme public sensitivity of the topic: behind glyphosate lurks the shadow of US multinational Monsanto, currently one of the most hated companies on the planet, which built its economic development around this wide-spectrum herbicide and GM crops engineered to tolerate it. Monsanto coordinated industry producers into a Glyphosate Task Force (GTF) to facilitate the pesticide’s review approval.

But the story has more to it than a political tussle. While conflicts are common in science too, resolving them relies on scientists reviewing and debating the evidence. The problem is this step cannot be taken because parts of this evidence are missing.

Three industry-sponsored carcinogenicity studies on mice, in particular, are not accessible to IARC while EFSA insists they played an important role in informing its decision. This situation is unfortunately typical of debates on pesticides regulation. This is why for years Corporate Europe Observatory and others have been asking EFSA and the European Commission that, just as with clinical trials for medicines, the data supporting EFSA’s scientific opinions should systematically be made public to enable free scientific scrutiny.

To find out more about the basis of the glyphosate decision we filed an access to documents request to EFSA in December 2015 to demand the disclosure of these three mouse studies. EFSA refused, and justified this on the basis that the owners of the studies, all industry producers of glyphosate, said disclosing this evidence would undermine trade secrets and intellectual property rights. Corporate Europe Observatory is appealing that decision by EFSA.

Meanwhile, the political process goes on, with the European Commission expected (according to EU sources) to propose member states start discussing a new EU-wide renewal of glyphosate’s market authorisation next 7th or 8th March.

Adding to the tension, France’s food safety agency ANSES published on 12 February an opinion contradicting EFSA’s (even though ANSES officials had contributed to it) by saying that glyphosate could perhaps, after all, be classified as a substance suspected of being carcinogenic to humans – a category which would not imply an EU ban – and that more research should be done, in particular by the European Chemicals Agency (ECHA) in Helsinki.

The ‘mysterious three’

The starkest difference between the EU’s regulatory agencies and the independent scientists who wrote IARC’s assessment perhaps lies in their respective interpretation of the animal evidence.

The conflict is particularly intense over the EU’s use of five industry-sponsored carcinogenicity studies in mice reviewed by BfR and EFSA. Two of these studies, from 1983 (‘A chronic feeding study of glyphosate (Roundup technical) in mice 77-2061! (BDN-77-420)’) and 1993 (‘Glyphosate: 104-week dietary carcinogenicity study in mice, IRI 438618’), were already included in industry’s first EU level request for a market authorisation for glyphosate.

But industry sent three new unpublished studies for the EU market authorisation renewal – the ‘mysterious three’, as scientific literature reviews specialist Paul Whaley dubbed them):

• ‘Carcinogenicity Study with Glyphosate Technical in Swiss Albino Mice’ (2001), following OECD Guideline 451 & GLP – study owned by the Israeli pesticides company ADAMA Agan Ltd and was never published;
• ‘Glyphosate technical: Dietary Carcinogenicity Study in the Mouse’ (2009), following OECD Guideline 451 & GLP – study owned by the Australian pesticides company Nufarm and was never published;
• ‘HR-001: 18-Month Oral Oncogenicity Study in Mice’ (1997), following following OECD Guideline 451 & GLP – study owned by the Japanese pesticides company Arysta LifeSciences Corporation and was never published.

One study, two very different interpretations

The names of the authors of all five studies are redacted in EFSA’s publications. In a Twitter exchange on the matter, Monsanto Europe explained this was for security reasons: “If you get scientists’ names what’s stopping people going after them/families?”

The company later added to its first reply saying: “It’s a sad fact that some activists target Monsanto employees for harassment.” But this seems simply irrelevant in this case given that not a single Monsanto employee seems to have been involved in the conduct of these studies.

Despite the first two studies, from 1983 and 1993, also not having been published, IARC could access them. Indeed it interpreted the 1983 study as showing “a significant increase in the incidence of rare tumours, with a dose-related trend, which could be attributed to glyphosate.”

That makes a stark contrast with EFSA and BfR’s review of the same study. IARC’s interpretation of the 1993 study is on the other hand consistent with EFSA and BfR’s. But it could not evaluate the three more recent studies, even though it was able to access summaries which its scientists commented showed incidence of various tumours.

‘Key’ and ‘pivotal’ evidence

The Mysterious Three are an essential element of the conflict. This is particularly so because EFSA heavily referred to them to explain its assessment, with José Tarazona, the Head of EFSA’s Pesticides Unit in charge of the assessment, calling them “key” and “pivotal”.

Similar comments can be found from various member states’ experts, with Belgium insisting that “it was unfortunate that IARC did not take into account 3 guideline studies in both mice and rats, since this could have put the overall conclusions in another perspective.” This very unfair sentiment – IARC could not access these studies – was echoed by Ireland: “IARC’s failure to evaluate the 3 other studies is not helpful.”

Since EFSA’s publication, the agency has been arguing that there is enough detailed information in its documentation to perform a good analysis, but IARC scientists respond that the descriptions and summaries published miss key elements and cannot replace original data.

Among these missing elements, IARC said, are “the historical control data from the reporting laboratory for all tumours with statistically significant positive increases, by either test recommended by OECD; another is the survival of the animals.” More generally, IARC pointed to its list of attention points for all studies it assesses.

Secret perfection or convenient argument?

So what is in these Mysterious Three? How can only three studies explain such a striking contrast? Would they be so strong as to convince IARC to reverse its stance? Would they on the contrary confirm it?

Or, given the strong political interest in this file and the fact that the EU’s Pesticides Regulation would force glyphosate out of the market were its cancer-causing properties confirmed, isn’t referring to these secret studies a convenient argument for all those willing to keep glyphosate on the EU market anyway?

In its response to Corporate Europe Observatory on 5th February 2015 explaining why it would not release the information, EFSA said that the studies’ owners (who, by law, must be consulted) refused any disclosure because they considered their studies to contain trade secrets and intellectual property which if released would harm their industrial and commercial interests as well as their “competitive position”.

EFSA agreed with this analysis and explained that, according to the exception foreseen in the EU’s Public Access to Documents Regulation 1049/2001 as well as in the EU’s Pesticides Regulation 1107/2009, it was entitled to not disclose the documents.

Abusive use of the trade secrets protection argument

However, both regulations only protect commercial interests and, in the case of the Pesticides Regulation, a limited list of elements within the studies, not the whole document – it is difficult to believe that everything in a scientific study would be a trade secret.

Moreover, the EU’s Pesticides Regulation stipulates that any data owner refusing disclosure of its material must provide a verifiable proof that disclosure would harm him, which was apparently not done.

Finally, glyphosate has been off-patent for 15 years and most pesticide companies now producing glyphosate belong to the Monsanto-led Glyphosate Task Force, the group that bundled all these studies together and sent them to the BfR and EFSA. How would disclosing these studies harm any of these companies’ competitive position if they were already shared among the main competitors?

As a consequence, CEO is appealing this decision, hoping that EFSA will use the opportunity of this major file and controversy to demonstrate its good faith in actually acting upon its declared intentions on data transparency and providing a level of openness that enables this conflict to evolve into a more productive, evidence-based discussion.

David vs. Goliath legal action in play since 2011

The data used by the European Commission to grant a market authorisation to glyphosate has been a much-debated issue for a long time.

In October 2011 Greenpeace Netherlands and Pesticides Action Network Europe took action against the European Commission and at the European Court of Justice to compel it to disclose the glyphosate industry’s secret dossier. In October 2013 the Court’s General Court ordered the European Commission to disclose large sections of the documents.

But the European Commission lodged an appeal which is ongoing. From March 2015 onwards, the European Commission has received support from numerous industry groups in this appeal:

• the European Crop Protection Association (‘ECPA’), which argues that “an adequate protection of confidential business information (‘CBI’) is essential in order to preserve and stimulate innovation and thus competitiveness and growth in the EU crop protection sector.”
• CropLife International, the international lobby group of the pesticides industry, whose members “account for approximately 75% of sales across the crop protection industry worldwide” and whose interest consists in “promoting the interests of its members as regards, inter alia, the protection of intellectual property and, in particular, confidential business information.”
• A delegation of US industry, composed of CropLife America, Inc., the National Association of Manufacturers of the United States of America and the American Chemistry Council, Inc., who argue that “the present appeal, since it concerns a conflict between the right of access to documents concerning the environment and the protection of confidential business information that manufacturers of chemical products are required to submit to the competent authority, raises a question of principle which is liable to affect the interests of [their] members.”
• the European Chemical Industry Council, the EU’s chemicals industry, arguing that “it has for many years underlined the importance of an adequate protection of confidential business information (‘CBI’) for the competitiveness of the EU chemicals industry.”
• the European Crop Care Association, an association representing small and medium-sized enterprises operating in the generic pesticides industry, who says that “the Court’s judgment in the present appeal will have a significant impact on the small and medium-sized enterprises which it represents, which rely heavily on industrial secrets to protect their intellectual property and innovation.”

MEPs – reject the ‘Trade Secrets Directive’!

As an important aside, CEO also calls MEPs to reject the so-called Trade Secrets Directive, whose final vote in the European Parliament is announced for next April 12.

As a matter of fact, one of the numerous problems with this text is that it would give companies additional arguments to fight public interest disclosures in court by threatening public authorities with massive financial penalties would they dare to disclose information they consider a trade secret.

This article was originally published by Corporate Europe Observatory. Please refer to the original version for full list of references etc.