GM Free Cymru

Glyphosate assessment: more corrupt science from EFSA

Date Added to website 16th November 2015

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Glyphosate assessment: more corrupt science from EFSA
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We have pasted below some of the reports published today, highlighting the extraordinary bias and complacency which comes out of all EFSA's published statements. It is clear that EFSA decided long ago that glyphosate would not be labelled as carcinogenic, because that was the recommendation in the German report, which was largely written by the industry-led Glyphosate Task Force. That is corrupt enough, but it gets worse. EFSA now claims that its study is somehow more reliable and comprehensive that that of the UARC, because it used extra studies. We have asked them to specify exactly what those studies were, but they have failed to respond. Others have already pointed out that they were industry studies which are not published in peer-reviewed journals and which are not in the public domain. They are secret industry studies which cannot be independently scrutinized. So they are effectively worthless from the point of view of transparent and honest science -- which is what we all want.

Then it gets even worse. In several statements today, EFSA has promoted the pretence that the IARC study was somehow less reliable than theirs because the IARC scientists looked at both glyphosate and glyphosate-based formulations. See below. See this quote: "EFSA scientists, who worked with experts from EU member states, said their study differed from IARC's in that it considered only glyphosate, whereas IARC had assessed groups of related chemicals. They said the toxic effects could be related to reactions with "other constituents or co-formulants".

So basically EFSA is seeking to undermine the IARC work on the basis that the scientists looked at "co-formulations" and that these "co-formulations" might have introduced the toxic effects that led them to say that glyphosate is a "probable carcinogen." That is a complete travesty. The IARC team very carefully separated out glyphosate-related effects from the effects of "glyphosate-based formulations" -- that's very sound, careful science. The IARC assessment was much more careful and comprehensive than that of EFSA, and it was conducted by medical practitioners and cancer specialists. Furthermore, it was based entirely on accessible studies, and not secret ones. When the IARC team said that glyphosate is a probable carcinogen for humans, they said what they meant and meant what they said.

Conclusion? EFSA shows yet again that it is complacent, that it is corrupt, that it is incapable of sound science, that it is led by the nose by powerful corporations, and that it is unfit for purpose.

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From EFSA's extraordinary and twisted explanation of its glyphosate assessment:
Quote:

"The International Agency for Research on Cancer (IARC) said earlier this year that glyphosate was genotoxic and would “probably” cause cancer in humans.
However, the IARC report looked at both glyphosate – an active substance – and glyphosate-based formulations, grouping all formulations regardless of their composition. The EU assessment, on the other hand, considered only glyphosate. Member States are responsible for evaluating each plant protection product that is marketed in their territories.
This is because the EU and IARC take different approaches to the classification of chemicals. The EU scheme –assesses each individual chemical, and each marketed mixture separately. IARC assesses generic agents, including groups of related chemicals, as well as occupational or environmental exposure, and cultural or behavioural practices.
This is important because although some studies suggest that certain glyphosate-based formulations may be genotoxic (i.e. damaging to DNA), others that look solely at the active substance
glyphosate do not show this effect. It is likely, therefore, that the genotoxic effects observed in some glyphosate-based formulations are related to the other constituents or “co-formulants”. Similarly, certain glyphosate-based formulations display higher toxicity than that of the active ingredient, presumably because of the presence of co-formulants. In its assessment, EFSA proposes that the toxicity of each pesticide formulation and in particular its genotoxic potential should be further considered and addressed by Member State authorities while they re-assess uses of glyphosate-based formulations in their own territories.
This distinction between active substance and pesticide formulation mainly explains the differences in how EFSA and IARC weighed the available data. For the EU assessment, studies conducted with glyphosate were more relevant than studies conducted with formulated products containing other constituents, particularly when the other constituents could not be clearly identified."


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Here are some of today's reports on the glyphosate assessment, from GM watch:

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Glyphosate not a carcinogen, says EFSA (of course)
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EFSA relies on secret industry studies to give glyphosate clean bill of health; washes its hands of Roundup and other toxic herbicide formulations

The European Food Safety Authority (EFSA) has published its conclusion on the safety of glyphosate and whether its EU approval should be renewed. Not surprisingly, EFSA has concluded that glyphosate “is unlikely to be genotoxic (i.e. damaging to DNA) or to pose a carcinogenic threat to humans”.

This contrasts with the finding of the World Health Organisation’s cancer agency IARC that glyphosate is a “probable” carcinogen and the statement of IARC expert Prof Chris Portier that it is “definitely genotoxic”.

Did EFSA consider more studies than IARC?

EFSA says it considered more studies than the IARC, as if that made its report more authoritative. Yes, it did consider studies that IARC didn’t. But what EFSA omits to mention is that the extra studies were done by industry. That means they are not peer-reviewed or published and are kept secret from the public and scientists. IARC only took into consideration published studies – a policy that ensures transparency for the public and the scientific community.

Another difference in approach is, as EFSA comments, “The IARC report looked at both glyphosate – an active substance – and glyphosate-based formulations, grouping all formulations regardless of their composition. The EU assessment, on the other hand, considered only glyphosate” as a single isolated ingredient. 

We know from many studies that the formulations are far more toxic than the isolated active ingredient and the formulations are, after all, what we are all exposed to. EFSA admits that it is “likely” that the “genotoxic effects observed in some glyphosate-based formulations are related to the other constituents or ‘co-formulants’”. EFSA adds that “certain glyphosate-based formulations display higher toxicity than that of the active ingredient, presumably because of the presence of co-formulants”.

EFSA says it’s not its job to consider the formulations: “Member states are responsible for evaluating each plant protection product that is marketed in their territories.”

Technically EFSA is right. EU-wide pesticide regulation, which EFSA opinions feed into, only considers the isolated active ingredient in a pesticide – glyphosate, in the case of Roundup.

In reality, however, when it comes to regulating GMOs, EFSA can take into consideration whatever effects it likes, direct or indirect. Most GMOs are tolerant to glyphosate herbicides, so EFSA could include the effects of pesticide formulations in its GMO assessments. Needless to say, it does not.

Anyone who thinks the member states will save us from glyphosate herbicide toxicity probably has not looked at the current state of national member state expertise. Anyone who does look is likely to see a sorry picture of underfunding and still-diminishing capacity. They are also likely to see a basic lack of understanding of how pesticides must be assessed – but in order to protect the public from health risks and to protect any regulator who takes her job seriously from a lawsuit brought by the pesticide industry.

In addition, the public interest work to unravel the web of secrecy surrounding national pesticide regulators of member states and to uncover their potential conflicts of interest with industry has barely begun.

If we leave it to member states to regulate formulations, it will never happen. The real battle against glyphosate herbicides and similar toxic products will likely be fought and won between consumers and retailers.

1. EFSA’s (un-)scientific opinion: glyphosate not a carcinogen
2. EU whitewash on cancer risk from world’s most used weedkiller
3. Soil Association press comment on EFSA's decision that glyphosate does not cause cancer
4. European scientific advisers say glyphosate unlikely to cause cancer
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1. EFSA’s (un-)scientific opinion: glyphosate not a carcinogen
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Pesticide Action Network Europe, 12 Nov 2015
http://www.pan-europe.info/press-releases/2015/11/efsa%E2%80%99s-un-scientific-opinion-glyphosate-not-carcinogen

PAN Europe is extremely disappointed with today’s European Food Safety Authority (EFSA) opinion concluding that glyphosate is not classified as a human carcinogen. Instead of doing an independent assessment on the pesticide, EFSA’s work is a copy of the German Government agency BfR’s assessment and the pesticide industry dossier compiled by the Glyphosate Task Force, hiding and misinterpreting the tumour incidences from experimental studies. This opens the road to the re-authorization of this dangerous pesticide in the EU, which was recently classified as “probable human carcinogen” by the International Agency for Research on Cancer (IARC) of the World Health Organization.[1]

EFSA published today its conclusion on glyphosate and found it “unlikely to pose a carcinogenic hazard to humans”. This contradicts the previous assessment from 17 international experts of IARC concluding glyphosate is a “probable carcinogen” due to limited scientific evidence of carcinogenicity in humans, sufficient evidence of carcinogenicity in experimental animals and evidence on genotoxicity.

The contradiction between IARC’s report and EU Authorities on glyphosate classification was examined by toxicologist Dr Peter Clausing (PAN Germany) who detected major flaws in the assessment of glyphosate by German BfR.[2] In his critical review, Dr Clausing highlights that even without considering independent academic literature, significant tumour incidences were found in five mice studies and at least two rat studies of the regulatory animal experiments produced by the industry. Unlike IARC’s assessment and against OECD rules, BfR and now EFSA, consider these tumour incidences as irrelevant to glyphosate exposure, by: i) cheating on the use of the “control” groups , ii) overlooking statistically significant results, iii) considering cancer incidences from human epidemiology studies as inconsistent and iv) totally dismissing genotoxicity data as non-relevant (due to the ‘lack’ of carcinogenic effects!).

PAN Europe’s Chemicals Officer Hans Muilerman comments, “EFSA’s opinion violates the precautionary principle; BfR and EFSA only conclude to adverse effects in case of overwhelming evidence; in case of doubt they give the advantage of the doubt to industry instead of giving priority to the protection of human health and the environment”.

Furthermore, environmental toxicologist Dr. Angeliki Lysimachou highlights “European citizens trust the Commission that if a chemical is ‘probably carcinogenic’, it will be banned from agriculture and won’t end up as residues in food and the environment. It is unacceptable that EFSA decided to dismiss the scientific evidence showing the potential of glyphosate to cause cancer and genotoxicity, putting at risk human health and the environment”.

Notes

1. http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf
2. http://www.pan-germany.org/download/PAN_Germany_Addendum_analysis_09112015.pdf
3. In animal experiments, the exposed groups are always compared to a control (unexposed) group. In the industry studies some of the unexposed control groups did not develop tumours. But, instead of using these data for a control, the RMS and now EFSA have selected to compare their carcinogenicity data of exposed animals with historical controls (from different laboratories and rodent strains) of animals that have tumours. In this way the tumours in the glyphosate exposure groups appear “statistically insignificant”. 


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2. EU whitewash on cancer risk from world’s most used weedkiller
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Greenpeace, November 12, 2015
http://www.greenpeace.org/eu-unit/en/News/2015/EU-whitewash-on-cancer-risk-from-worlds-most-used-weedkiller/

* Overreliance on unpublished industry studies leads EU food agency to recommend glyphosate approval

A report released today by the European Food Safety Authority (EFSA) could pave the way for EU re-approval of the world’s most used weedkiller – glyphosate – which has been linked to cancer by the World Health Organisation (WHO). The report heavily relies on unpublished studies commissioned by glyphosate producers and dismisses published peer-reviewed evidence that glyphosate causes cancer, said Greenpeace.

Greenpeace EU food policy director Franziska Achterberg said: “EFSA’s safety assurances on glyphosate raise serious questions about its scientific independence. Much of its report is taken directly from unpublished studies commissioned by glyphosate producers. The evidence of harm is irrefutable but EFSA has defied the world’s most authoritative cancer agency in order to please corporations like Monsanto.”

EFSA evaluated six animal experiments that the WHO did not include in its review because the data has not been published or peer reviewed. Several of these industry studies support the IARC classification by showing increased cancer rates in animals, but EFSA claims these cannot be attributed to glyphosate.

In the coming months, the European Commission will recommend whether glyphosate should still be used in the EU after its current approval runs out on 30 June 2016. An EU technical committee is expected to examine the Commission’s recommendation in early 2016.

In March, the WHO’s agency for research on cancer (IARC) classified glyphosate as a probable human carcinogen [1].

Under EU law, a “presumed” link to cancer means a pesticide cannot be used, unless human exposure can be shown to be “negligible” [2]. Glyphosate is so widely used that human exposure is unavoidable. It is commonly found in the air, in water, in city parks, on farmland and in food, such as bread.

Health risks associated with the use of glyphosate, including the link to cancer, will also be investigated by the European Chemicals Agency (ECHA). However, ECHA is not expected to release its report until 2017.

Achterberg added: “The dispute between scientists is not over, and what’s more, the EU’s chemicals agency could take a different view from EFSA. It makes no sense to give glyphosate another ten-year licence until that process is over. After its failure to protect the health of Europeans from car emissions, the Commission should not make the same mistake on pesticides.”

Environmental and health organisations have called for a ban of all uses of glyphosate where people and workers are most exposed [3]. They have urged the Commission to take full account of the WHO’s warning, and to base its decision on the advice of both EU agencies.

Notes:

[1] IARC press release, 20 March 2015: http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf

[2] Regulation 1107/2009: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF

[3] Civil society letter, 29 October 2015: http://www.greenpeace.org/eu-unit/Global/eu-unit/reports-briefings/2015/Glyphosate%20letter%20with%20logos_29102015.pdf

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3. Soil Association press comment on EFSA's decision that glyphosate does not cause cancer
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Soil Association, 12 November 2015
http://www.soilassociation.org/news/newsstory/articleid/8549/soil-association-press-comment-on-efsas-decision-that-glyphosate-does-not-cause-cancer

Peter Melchett, policy director at the Soil Association said: “The EFSA decision is absolutely no surprise. Given that this review of glyphosate relies almost entirely on industry funded, unpublished studies, it would be unthinkable for the EFSA to come to any conclusion other than that glyphosate is safe to use. The reason that other eminent international scientists advising the WHO have already come to different conclusions is, as the EFSA themselves admit, purely because the other scientists are considering a much wider range of evidence than just industry studies, and they are looking at the impacts of glyphosate as it is actually used.

Although glyphosate is always used in combination with a range of other often toxic chemicals, and although researchers have found that glyphosate mixes as sold to farmers and gardeners can be 1000 times more toxic than glyphosate acting on its own, the EFSA insists on looking at the impact of glyphosate alone. It is blindingly obvious that the WHO approach is right from the perspective of public safety, and that the EFSA approach simply serves the interests of the pesticide companies.

“The next serious scientific review of glyphosate will be carried out by the European Chemicals Agency (ECHA), the regulatory authority responsible for implementing the EU's chemicals legislation and protecting human health and the environment. The ECHA will be consulting on their findings at the end of this month. Their conclusions may still condemn glyphosate and prevent the weed killer being re-approved under EU law.”

The Soil Association is campaigning to stop glyphosate being sprayed on wheat destined for use in UK bread.
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4. European scientific advisers say glyphosate unlikely to cause cancer
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Reuters, Nov 12 2015
http://news.yahoo.com/european-scientific-advisers-glyphosate-unlikely-cause-cancer-111029054--finance.html

The European Food Safety Authority (EFSA) on Thursday said glyphosate, the active ingredient in Monsanto weedkiller Roundup, was unlikely to cause cancer in humans, but it proposed new controls on any residues in food.

EFSA advises EU policymakers and its conclusion will be used by the European Commission to decide whether to extend the current approval period for glyphosate, which ends on Dec. 31.

Environmental groups have been calling for a ban after the International Agency for Research on Cancer (IARC), part of the World Health Organization, said in March that glyphosate was "probably carcinogenic to humans".

Some businesses and authorities have sought to limit glyphosate use.

"This has been an exhaustive process - a full assessment that has taken into account a wealth of new studies and data," Jose Tarazona, head of the pesticides unit at Parma, Italy-based EFSA, said in a statement.

"Regarding carcinogenicity, it is unlikely that this substance is carcinogenic."

EFSA scientists, who worked with experts from EU member states, said their study differed from IARC's in that it considered only glyphosate, whereas IARC had assessed groups of related chemicals. They said the toxic effects could be related to reactions with "other constituents or 'co-formulants'".

However, they are for the first time proposing a limit on the maximum safe daily dose, of 0.5 milligrams per kilogram of body weight.

That means an 80-kg person could eat food containing 40 milligrams of glyphosate per day for the rest of their life.

(Reporting by Barbara Lewis; Editing by Dale Hudson)