Roundup - Ready to go?

Is 'Roundup' carcinogenic, and can it cause cancers in humans?

"While glyphosate is the most frequently used herbicide in Europe, “there is little information available on occupational or community exposure to glyphosate,” according to IARC. 

Latest

2017

BMJ asks 'Is it time to re-assess safety standards for glyphosate herbicides? saying "Methods used in environmental health sciences to examine the potential health effects of chemicals, including pesticides, have undergone substantial changes over the past 30 years. Cutting-edge tools currently employed by federally furequired by regulatory agencies and used in formal risk assessments."nded scientists bear little resemblance to the archaic standardised assays 

ECHA says glyphosate is not a carcinogen RAC concluded that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction. This will be taken into account by the Commission and Member States later in the year when deciding continued authorisation of the active ingredient.

2016

December

European Chenicals Agency collected evidence from 6 key organisations. The Committee for Risk Assessment (RAC) held its first preparatory discussion on the harmonised classification and labelling of glyphosate. To facilitate a balanced overview of a wide range of scientific views, six organisations were invited to give presentations, followed by an initial plenary discussion. Helsinki, 7 December 2016 – The presentations were given by the German Federal Institute for Occupational Safety and Health (BAuA) as the dossier submitter, the European Food Safety Authority (EFSA), the International Agency for Research on Cancer (IARC), the joint FAO/WHO meeting on pesticide residues (JMPR), industry’s glyphosate task force (GTF) and a representative of civil society (Health And Environmental Alliance, HEAL). All of the presentations are now available on ECHA’s website. How the Assessment is being carried out

September

US Environmental Protection Agency (EPA) says Glyphosate unlikely to be carciniogenic. "The EPA's "proposed" position on glyphosate was outlined in a 227-page paper it published on the regulations.gov website, which the EPA manages.After reviewing the available data, the paper states, "The strongest support is for 'not likely to be carcinogenic to humans' at doses relevant to human health risk assessment.The paper was among 86 documents, which included dozens of research studies about glyphosate. All the material is to be reviewed next month by an advisory group of scientists known as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Pane"

July

Millers reject call for ban on preharvest Glyphosate from Soil Association

June

The European Commison agree to license glyphosate for a further limited period of 18 months. after member states failed to reach qualified majority decision. This period was to allow the European Chemicals Agency (ECHA) to give an opinion on the substance, which is expected no later than 31 December 2017.

Member states unlikely to accept Commission proposals to extend authorisation temporarily

May

Germany set to approve (although Mail suggest abstention) as is Malta

EU vote delayed..They have to make decision by end of June, otherwise license expires. the delay has been caused by WHO & FAO report agreeing that "“glyphosate is unlikely to pose a carcinogenic risk to humans from exposure through the diet.” The ScientistSeveral E.U. member states, including France and Germany called for delaying the vote until the confusion is cleared up. “Safety first, health first. I am against authorizing this product until these doubts have been entirely ruled out,” Sigmar Gabriel, Germany's vice chancellor told The Wall Street JournalThe WHO tried to clear up its seemingly conflicting assessments of glyphosate: it says in a FAQ that the new report and the 2015 report are “different, yet complimentary” because the earlier one is a Hazard Identification, which is the first part of a Risk assessment that then takes in the estimated exposure to target organisms. 

[A Risk Assessment estimates the 'toxicity X the likelihood' of exposure. More on Risk Assessment. 'Risk Assessment' is the basis of all UK Health and Safety law.]

Netherlands Ban Roundup sales to private parties.

IUF Rossman Roundup

April

S&D's critcise Commisioner for Health & Food Safety for proposing to re-authorise glyphosate for 10 years with no restrictions.S&D spokesperson on health and environment, Matthias Groote MEP, said: "The decision by the Parliament cannot be ignored. Last week we passed a resolution which was already very balanced: it restricted the use of glyphosate for seven years, and only to those cases where no alternative methods exist, but banned it in pre-harvest agricultural use, in public parks and in playgrounds. 

MEPs to vote April 13 are being urged to apply precautionary principle in light of conflicting evidence - or rather lack of it, and by NFU to clear its license for next 15 years. In the event MEPs voted by 375 to 225 to re-license but for a shorter period - 7 years rather than usual 15  yrs."The non-binding resolution calls for the licence to restrict application for professional uses only and says glyphosate should not be approved for use in or close to public parks, public playgrounds and public gardens. MEPs also condemned the ’unacceptable’ use of the world’s most widely used herbicide to kill crops prior to harvest in order to accelerate ripening and facilitate harvesting, in a farming practice they described as ’green burndown’.".

March

Risk-Monger Glyphosate and IARC-gate spells out how somebody from anti-industry NGO Environmental Defense Fund got into IARC..

EU delays glyphosate decision amid cancer concerns By Niamh Michail+, 09-Mar-2016 "The European Commission delayed making a decision on glyphosate yesterday as four member states, including the EU Presidency-holding Netherlands, France, Italy & Sweden, said they would vote against renewing Monsanto's licence, leaving campaigners claiming a temporary victory. " The Commission said it was only ever a discussion, but the issue of co-formulants was an issue to be addressed.

Nearly 100 scientitst analyse difference between IARC and EFSA assessments, saying EFSA should not have dismissed same evidence that IARC used to reach its conclusions.

February

EFSA Letter responding to open letter (below), saying IARC and EFSA have different legal responsibilites. It says that Member state scientists have to sign 'Declaration of Interest (DoI), basically preventing scientists directly involved in the assessment having a say. IARC has similar process, but seems to allow individual specialist to be invited but not to chair. Also proposes meeting between EFSA and IARC

2015

IARC Full Monograph 

30 Nov An open letter signed by 96 scientists including nine of the IARC authors, all specialised in relevant disciplines (cancer research, epidemiology, toxicology, occupational health...) was sent on November 30 2015 to the European Commission and EFSA urging them to consider the differences in IARC and BfR conclusions. The scientists, presenting themselves as having "dedicated [their] professional lives to understanding the role of environmental hazards on cancer risks and human health", argue that "the BfR decision is not credible because it is not supported by the evidence and it was not reached in an open and transparent manner" and call the European Commission to "disregard the flawed EFSA finding on glyphosate in your formulation of glyphosate health and environmental policy for Europe and to call for a transparent, open and credible review of the scientific literature." They list several reasons to complain about the EFSA/BfR process, saying :"We strongly object to the almost non-existent weight given to studies from the literature by the BfR and the strong reliance on non-publicly available data in a limited set of assays"

Nov 2015 EFSA (European Food Safety Authority - basically the EU Risk Assessment body) say 'Glyphosate unlikely to be carcinogenic. Nevertheless they pushed for new measures to reduce residues in food (a maximum safe daily dose). EFSA decision in full "The report concludes that glyphosate is unlikely to pose a carcinogenic hazard to humans and proposes a new safety measure that will tighten the control of glyphosate residues in food. " A peer review expert group made up of EFSA scientists and representatives from risk assessment bodies in EU Member States has set an acute reference dose (ARfD) for glyphosate of 0.5 mg per kg of body weight" More details

The distinction between active substance and pesticide formulation mainly explains the differences in how EFSA and IARC weighed 
the available data." Basically, EFSA looked onl at the active ingredient, whereas IARC looked at it in formulations, as it is usually used in practice. (EFSA explanation of difference. EFSA considered more studies, including IARC, and interpreted same animal studies differently, saying they were insignificant compared to IARC saying they were significant, because high doses not very relevant. More debate 'Has science won?" A criticism of IARC decision is that some members of the committee relied on their own work to help make the decision. This is called 'impartial'. The main criticism of the EFSA process is that the process didn't involve its expert science committee, relying on public officials who were anonymous. So they may be impartial, but we don't know. They used studies from industry not available to IARC or other outside scrutiny. Nevertheless, they “recognized that the issue of toxicity of the formulations should be considered further15

So which version do we believe? Publishing the raw data used by EFSA might settle the matter, but NGO Pesticides Action Network Europe has been fighting in courts for years trying to obtain this very data on glyphosate and so far companies have always refused to disclose it and let independent scrutiny on their data take place.

Guardian Roundup (Geddit?)

National geographic review says “The EPA is reviewing its approved uses of glyphosate and expects to release a preliminary assessment of the human health risk later this year. This is expected to include new restrictions.

Meanwhile, Sri Lanka, alarmed by suspected links to human kidney disease, has banned it. Brazil is considering a similar move. Mexico and the Netherlands have imposed new restrictions, and Canada has just begun a process to consider new rules.

Columbia bans Glyphosate on coca May 15 2015 Local farmers will be pleased, not because they are not getting cancer but because their crops are not being sprayed with it.

Netherlands ban Glyphosate

Introduction

IARC published paper in Lancet and the GfP wo are responsible for assessing its dangers challenged the results, so again how science works in society is thrown up. Sides were soon taken…

Monsanto immediately asked for retraction saying it was based on ‘junk’ science The Glyphosate Task Force (of main companies) did not accept the new classification. The likes of Avaaz got a click campaign going to ‘Ban it ban it!’. There is a real temptation to click, and somehow poke Monsanto in the eyes/pocket. But where is the science in all this?

The Corporate European Observatory ‘Glyphosate Sage and Independent Sceince’ spellout the structures and .pressures on making scientific decisions these days, when there isn’t much public space left and whatever the scientists say, somebody will shout ‘rubbish’.

I feel sorry for the scientists involved. Most wont have been trained in the philosophies of science or about science and society. But they will have been drummed into being ‘objective’.

When CEO (and many others) point out that 2-3 members of the GfP (EFSA or whoever) committee are from industry, they forget that the other 15+ will not be from industry. And I have seen these people close up and they can be very courageous in pointing out when some something is amiss. What may seem obscure to us, they will firmly say ‘no’, knowing the consequences for the manufacturers. It is not all one way bending. I learnt a lot of respect for many of the scientists involved in these committees when I was on the government’s  Advisory Committee on Pesticides for 5 years: I saw many with a keen eye, draw attention to some danger. There are also others trying to make a name for themselves. So sifting the science is important.

Paddy This kind of institutional disagreement is not unprecedented or entirely surprising. Evidence about chemical safety is often uncertain and ambiguous and therefore contestable. In particular, a series of of decisions need to be made when assessing safety than cannot always be resolved on the basis of evidence alone. What, for example, constitutes a reliable study? How should conflicting data be weighed? How much of what kinds of evidence are necessary to support a judgement about hazard, or its absence? If subjective judgements and assumptions, as well as evidence, are required to settle such questions, it is no surprise that disagreements sometimes occur.

Remember glyphosate toxicity is set against the background of anti-GM, which has in the last year or two being have a real go at Glyphosate, because is crucial to the biggest GM crop ‘Roundup Ready, where maize but also soya canola and sugar beets can grow through the Roundup – Glyphosate, but all other weeds get killed. These crops can withstand the herbicide glyphosate, so it is more widely used than in the past and more than any other herbicide across the world.

And then along came IARC part of the WHO saying they wanted to reclassify glyphosate as 2A. This is a big deal, and put glyphosate in with some of the ‘nastier’ insecticides lie Malathion.

Here are how IARC classified some organophosphate pesticides alongside glyphosate

The International Agency for Research on Cancer (IARC) preamble explains the classification system (amended January, 2006)…

“Group 2. This category includes agents for which, at one extreme, the degree of evidence of carcinogenicity in humans is almost sufficient, as well as those for which, at the other extreme, there are no human data but for which there is evidence of carcinogenicity in experimental animals. Agents are assigned to either Group 2A (probably carcinogenic to humans) or Group 2B (possibly carcinogenic to humans) on the basis of epidemiological and experimental evidence of carcinogenicity and mechanistic and other relevant data. The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.

Group 2A: The agent is probably carcinogenic to humans. This category is used when there is limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals. In some cases, an agent may be classified in this category when there is inadequate evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals and strong evidence that the carcinogenesis is mediated by a mechanism that also operates in humans. Exceptionally, an agent may be classified in this category solely on the basis of limited evidence of carcinogenicity in humans. An agent may be assigned to this category if it clearly belongs, based on mechanistic considerations, to a class of agents for which one or more members have been classified in Group 1 or Group 2A.

 

Parathion has long been banned just about everywhere and Tertachlorvinphos is banned in EU – both these are OP (organophosphates) with a history of nerve debilitating effects and occasional deaths. Putting glyphosate in worse category (albeit for different disorder) makes a splash.

The 2A classification of diazinon was based on limited evidence of carcinogenicity in humans and experimental animals, and strong mechanistic evidence; for malathion and glyphosate, the mechanistic evidence provided independent support of the 2A classification based on evidence of carcinogenicity in humans and experimental animals. Here is the IARC explanation”

The IARC paper says: “There was limited evidence in humans for the carcinogenicity of glyphosate. Case-control studies of occupational exposure in the USA,14 Canada,6 and Sweden7 reported increased risks for non-Hodgkin lymphoma that persisted after adjustment for other pesticides. The AHS cohort (see later) did not show a significantly increased risk of non-Hodgkin lymphoma. In male CD-1 mice, glyphosate induced a positive trend in the incidence of a rare tumour, renal tubule carcinoma. A second study reported a positive trend for haemangiosarcoma in male mice.15 Glyphosate increased pancreatic islet-cell adenoma in male rats in two studies. A glyphosate formulation promoted skin tumours in an initiation-promotion study in mice.

Glyphosate has been detected in the blood and urine of agricultural workers, indicating absorption. Soil microbes degrade glyphosate to aminomethylphosphoric acid (AMPA). Blood AMPA detection after poisonings suggests intestinal microbial metabolism in humans. Glyphosate and glyphosate formulations induced DNA and chromosomal damage in mammals, and in human and animal cells in vitro.”

Other substances/environments also classed as 2A include,hot drinks (above 65%), red meat , irregular shift patterns, being an hairdresser..

This is a big deal, a big jump in the expected toxicity of glyphosate, which up to now was considered (apart from some avid anti-GMers) pretty non toxic. Three epidemiological studies and a few mice studies showing ‘trends’, and some in vitro work. Does this warrant ‘probability’ of cancer as opposed to ‘possibility’?

IARC Chair Blair (no not that one) explains decision saying it had been a long time coming, and that

“The classification is appropriate based on current science. There have been hundreds of studies on glyphosate,  with concerns about the chemical growing over time. The IARC group gave particular consideration to two major studies out of Sweden, one out of Canada and at least three in the United States” He stressed “that the group did not classify glyphosate as definitely causing cancer. "We looked at, 'Is there evidence that glyphosate causes cancer?' and the answer is 'probably.' That is different than yes. The scientific understanding of glyphosate impacts is still evolving. "It is different than smoking and lung cancer. We don't say smoking probably causes cancer. We say it does cause cancer. At one point we weren't sure, but now we are."

As with many issues that involve science, there are groups jumping to conclusions, each claiming to have science on their side, often with little regard for the complexities involved. Debates within science are the norm, and so they should be. We expect scientists to be critical of each other. Otherwise the peer review process is not a safeguard. But those disagreements are now more in the public eye. And as such, there are many to claim that such and such position ‘proves’ their point. And it is all too easy to say the science is bent. Some weeks ago a good decent independent nutritionist was being attacked because she had accepted some grant for a partner project from a sugar company and was  thus  biased. She does an enormous amount of work to point out the dangers of sugar, yet gets castigated. Nothing upsets scientists’ more than this sort of thing – they work hard to be independent. The bigger picture may be dictated by the corporate, but many individual scientists work hard to be independent   She explained that with much less science in  the public sector, how can we get money to do the research? We should be campaigning for more – there was virtually nothing said in election, other than everybody agreeing that we need more ‘world class science’ But, as with all these matters, just like the law, we need to look at the evidence, and to assess that. 

When it comes to risk assessment it is not an ‘exact’ science. Risk Assessment is bedrock of government and EU approach to dealing with pesticides – and all other dangers at work. Risk Assessment consists of identifying the inbuilt nature of a chemical – ie their hazard, then determining the likelihood of that hazard affecting you/environment. It is out as Hazard X Likelihood = Risk. All our H&S law is based in this. Yet everybody has different perceptions of risk. And with pesticides there are two very different perceptions – dependent where you stand – literally, in relation to the spray.

If you are doing the spraying, you are more likely to say “don’t worry it is quite safer”.


But if you are in the way ...you are more likely to say 'Hold on stop'!.


So what may look safe from an ivory tower, looks quite different if you are in the path of it coming towards you – if you are a worker or nearby resident. In addition in developing countries, where the risk assessments are usually made, the controls are more developed, through legislation, union organisation and new technologies. But in other countries, the standards of control do not exist

So if we use a risk assessment, the basis of our law, it is quite justifiable to say that glyphosate isn’t likely to get to you in the amounts that may cause damage as it is a herbicide sprayed from machines general a long way away. While there is some spray in the garden it is less damaging than frying bacon, eating smoked fish or demolishing BBQed meat, all of which most of us are quite happy to consume. Risk assessment involves numerous uncertainties and subjective judgement, which are hard to build with science.

There is a distinction between scientific and regulatory bodies. Most regulatory agencies are very reluctant to acknowledge that there are choice-laden aspects to chemical safety assessment. This is partly because science is a powerful source of legitimacy, and so regulators often wish to portray their assessments as far more objective, reliable and consensual than is actually the case. But it is also because to do so would be an open invitation to scrutinise regulators’ technical assessments. We might reasonably want to ask how the choice-laden aspects of those assessments been exercised: in ways that resolve the ambiguities and uncertainties in favour of public health, or agriculture and agribusiness?

The EU allocates member countries to re-evaluate pesticides, and Germany had the responsibility for glyphosate a while back. It’s report was delayed due to over work, then published in early 2014 Federal Institute for Risk Assessment BfR . Where it said it had looked at a lot of studies, many to do with carcinogenicity and there was no need to change control, in fact suggesting the so called safety level (ADI – Acceptable Daily Intake) could be raised . It did draw attention to co-formulants – substances added to the herbicide to help it stick to plants etc.

This report was sent to the EU body responsible – called European Food Safety Agency. EFSA is often attacked as being in the hold of industry and ‘jeopardises public confidence’ (Greens 2012)– except when the same committee said there were ‘gaps in the risk assessment’ of neonicotinoids, where it is seen as bastion of science. (Green Party 2013) (much more on that)

The initial response of GfR to the IARC paper was

“In the opinion of BfR, the classification of glyphosate as "carcinogenic in Group 2A" (probably carcinogenic to humans) as published in the 20 March 2015 issue of the "Lancet" journal comes as a surprise, since other evaluations performed by supranational bodies such as the WHO-Panel of the Joint Meeting of Pesticide residues (JMPR, 2004), and also by national regulatory agencies such as the U.S.EPA had concluded the contrary, i.e., that glyphosate was not carcinogenic. Unfortunately, the database on which the IARC evaluation is based is not known, since a background monograph that is usually produced by IARC following the evaluation meetings has not yet been released. Therefore, a comprehensive and scientifically sound consideration of the data and arguments that led to the IARC- conclusion is simply not possible at the moment.”

And

“BfR has compiled the most comprehensive toxicological database, presumably worldwide, for glyphosate. This database comprises hundreds of studies that were performed by or on behalf of the many manufacturers of glyphosate and thousands of references from the open literature. This huge amount of data makes glyphosate nearly unique among the active substances in plant protection products. BfR thinks that the entire database must be taken into account for toxicological evaluation and risk assessment of a substance and not merely a more or less arbitrary selection of studies. In the absence of more reliable information from IARC, BfR has tried to allocate the findings that are mentioned in the brief “Lancet” publication to certain studies in our database and, by doing that, to put them into perspective. The new IARC classification for glyphosate as a carcinogenic substance is based firstly on “limited evidence” in humans. This risk is derived from three epidemiological studies in the USA, Canada and Sweden based on a statistical correlation between exposure to glyphosate and an increased risk of non-Hodgkin lymphoma. However, this assessment was not confirmed in a very large cohort of the also cited "Agricultural Health Study" (see below)  or in other studies.”  

See end of this document for the 3 epidemiological references and their abstracts. There is some rivalry between toxicologist and epidemiologists as to who can detect disorders best.

The Agricultural Health Study was a classic piece of epidemiology carried out in America ten or so years ago. The AHS is the largest study of farmers and their families in the world and has provided Epidemiology Branch investigators and collaborators with an invaluable source of information.  No higher rate of non-Hodgkin lymphoma found.

Further BfR said:” It is not possible to fully examine the indications for the genotoxic potential of glyphosate based on the short report published by IARC, in particular due to the fact that the assessment included studies using formulations that are not specified in any detail.” Remember they had drawn attention to the co-formulants separately in their first report.

BfR sent a final assessment early this month – following the IARC announcement, saying that because they had composed the original, it would be ‘inexpedient’ to comment on the IARC judgement, but leave that to member states.

It says: “ In BfR’s opinion, as soon as it is available, the complete IARC Monograph should be examined by a European expert panel under the direction of EFSA and the results should be incorporated into the EU-wide revised assessment of the active substance. In addition, the European Chemical Agency (ECHA), which is ultimately the competent authority for the legal classification of the substance glyphosate, should be involved in the very early stages of discussions. The BfR recommends emphatically that all those involved in the assessment of glyphosate, WHO panels, IARC and JMPR (Joint FAO/WHO Meeting on Pesticide Residues), as well as the competent EU-authorities EFSA and ECHA, should discuss the current disputable issues, with the aim of resolving the discrepancies, before the EU-Commission makes a decision on the further approval of glyphosate.”

However! Much of the German government’s (the Rapporteur Member State RMS) evaluation of  was not written by scientists working for the German Federal Institute for Risk Assessment (BfR). Rather, the European Glyphosate Task Force, a consortium of agrochemical firms including Monsanto, Dow and Syngenta wrote most of the near 1000 page Renewal Assessment Report (RAR) document, while the RMS added only a few comments. (See Swanson for details). The BfR in the RAR explains:
Due to the large number of submitted toxicological studies, the RMS was not able to report the original studies in detail and an alternative approach was taken instead. The study descriptions and assessments as provided by GTF were amended by deletion of redundant parts (such as the so-called ”executive summaries”) and new enumeration of tables.” In other words BfR  were overrun and hadn’t got the time to do it themselves, so let the industry do most of the work. I remember what it felt like on the ACP – the volume of information is incredible. But we would not let this have happen.

You would have thought all hell had been let loose when this came out as it was seen as’BfR have ignored IARC!’ . How can we do better than either rely on a cloudy risk assessment, or just shout ‘ban it!’ Is there another way?

Some years back, there was a move by ‘the Greens’ in the EU to base laws not on ‘Risk Assessment’ but on ‘Hazards characterisation’, thereby removing the vagueness of risk from the situation. I was on the UK’s Advisory Committee on Pesticides at the time, and all the rest of the committee advised  the UK government to stick with the Risk Assessment approach. The belief was that we should address what actually happens in the field rather than an inherent hazard. It reminded me of the old days when Britain was seen as the ‘Dirty man of Europe’ because of our policy to send smoke up our power stations, saying ‘well the hazard disperses’. The trouble was it dispersed over the rest of Europe. So I was alone on the committee – about 19-1, saying we should go for the Hazards approach. I did so on the basis that Hazard characterisation was the first step of a Risk Assessment anyway, and we should have the option there/then to  say ‘this shouldn’t come on the market’. We do do that. But also because, years ago, I created a magazine called Hazards Bulletin (now just ‘Hazards’).

This is the approach I remember using when advising one (or two) of the big – most ‘responsible’ retailers as to which pesticides they could use. We used international standard lists of chemicals for each criterion we thought relevant – say  toxicity, soil persistence, or water contamination, and then set ‘trigger points’. Two triggers were set for each criterion, one to raise a red flag for danger and one an amber one for ‘warning. Here are  a few examples

Hazard Triggers

Human Health

Proposed Trigger

Criterion

Measurement

Prohibit

Monitor

Chronic

ADI/RfD in mg/kg bw

>0.0005

NA

WHO  Classs

1a

1b

Carcinogenic

EU2: EPA A+B1: IARC 2A

EU3: EPA B2+C+L1+L2:IARC 2B

Occupational

MEL Set

OEL<1.0 mg/m3

Environmental Health

Soil Persistence

Days (DT50)- @20OC

>60 And if soil mobility trigger exceeded

>60 and if soil mobility (Koc) trigger (<50)not exceeded

Soil Mobility

Water Persistence

Bio Accumulation

Remember,  the intent of this was to set a higher standard than that required by law, as that is what some of the responsible retailers wanted to do to respond to consumer concerns.

We wanted a proper guide as to what to do so that others could follow and comment upon. I helped develop an 'algorithm to run through all the pesticides and see the main hazards (NOT risks) and to try and find a way to assess (BUT NOT Risk Assess) the inherent dangers in each substance.  This uses independent internationally recognised information applied in a transparent, logical and justifiable way. Using this ‘Hazard Trigger’ system, out of over 800 pesticides put through the algorithm, over 130 ended up on the Prohibited list. Glyphosate was not on the responsible retailers list.

But would be now - see carcinogenic above WHO 2A.

This gives a framework for making decision. This hazard trigger system could be more sophisticated by adding two pesticides that are used together and their  hazard triggers seen in combination.  We don’t have to think in one hazard at a time, and we could have an algorithm that did a few of the various criteria for any one pesticide. And we could all join in and judge it using a set of pre agreed criterion and triggers. Everybody could see what is going on.

So under our Hazard trigger Glyphosate is 'prohibited for responsible retailers. That is what is being quoted at Monsanto. But if the cancer ranking was merely ‘possible’ it would not be triggered. So the big question remains: how did IARC get from ‘possible’ to ‘probable’ on the basis of four epidemiological studies(inc AHS) which are very inconclusive, and some mice studies which indicate only ‘trends’? Look below at the abstracts of 3 supposedly important epidemiological studies, one of which doesn’t mention glyphosate, and one mentions it in a list of a dozen others.

I can’t help but notice the chair of the IARC committee that made the decision was widely quoted in the last of the papers quoted. I would have thought that there should be protocols against that sort of tautology.

Conclusion

1 The reassessment to ‘probable’ seems to be based on too few studies, none categorical in their conclusions. IARC are right when they say "While glyphosate is the most frequently used herbicide in Europe, “there is little information available on occupational or community exposure to glyphosate,”. There needs to be a lot more epidemiological work for a substance in such widespread use. It seems to come down to a few animal studies. We know that the ‘absence of evidence is not evidence of the absence’ but there really does not seem like much clear evidence. And there is nothing in any consistent direction. It would be good to hear from some of those who are not connected to the industry.

2 We should get a move on with identifying some of the data gaps, and fill them. Any data not in public arena should not be included. And then get a relevant committee to spell out the balances which have been made in terms of risk assessment. Rather than loads of organisations doing that I would suggest for one or two of the leading science organisations in the world – say EFSA and EPA to do it.

3 Reassess the NOEL (Non Observable Effect Level) – that level at which no effects are observed and then recalculate the exposure and daily intake levels (ADI) which are related to this. EFSA are now (late 2015) porposing this It may be a more precautionary approach is required, but not a ban. We do have many ways to control exposure, as evidenced by many other chemicals.

Reference quoted in IARC paper:

6. McDuffie, HH, Pahwa, P, McLaughlin, JR et al. Non-Hodgkin's lymphoma and specific pesticide exposures in men: cross-Canada study of pesticides and health. Cancer Epidemiol Biomarkers Prev.2001; 10: 1155–1163 Abstract says:

“We found that among major chemical classes of herbicides, the risk of NHL (Non Hodgkins Lymphoma) was statistically significantly increased by exposure to phenoxyherbicides [OR, 1.38; 95% confidence interval (CI), 1.06-1.81] and to dicamba (OR, 1.88; 95% CI, 1.32-2.68). Exposure to carbamate (OR, 1.92; 95% CI, 1.22-3.04) and to organophosphorus insecticides (OR, 1.73; 95% CI, 1.27-2.36), amide fungicides, and the fumigant carbon tetrachloride (OR, 2.42; 95% CI, 1.19-5.14) statistically significantly increased risk. Among individual compounds, in multivariate analyses, the risk of NHL was statistically significantly increased by exposure to the herbicides 2,4-dichlorophenoxyacetic acid (2,4-D; OR, 1.32; 95% CI, 1.01-1.73), mecoprop (OR, 2.33; 95% CI, 1.58-3.44), and dicamba (OR, 1.68; 95% CI, 1.00-2.81); to the insecticides malathion (OR, 1.83; 95% CI, 1.31-2.55), 1,1,1-trichloro-2,2-bis (4-chlorophenyl) ethane (DDT), carbaryl (OR, 2.11; 95% CI, 1.21-3.69), aldrin, and lindane; and to the fungicides captan and sulfur compounds”.

My comment: There is no mention of glyphosate, although many other pesticides implicated. Remember ‘significant’ means a pointer to possible problem, not proof…which is relevant with next study

7. Eriksson, M, Hardell, L, Carlberg, M, and Akerman, M. Pesticide exposure as risk factor for non-Hodgkin lymphoma including histopathological subgroup analysis. Int J Cancer. 2008; 123: 1657–1663 Abstract says:

Exposure to herbicides gave odds ratio (OR) 1.72, 95% confidence interval (CI) 1.18–2.51. Regarding phenoxyacetic acids highest risk was calculated for MCPA; OR 2.81, 95% CI 1.27–6.22, all these cases had a latency period >10 years. Exposure to glyphosate gave OR 2.02, 95% CI 1.10–3.71 and with >10 years latency period OR 2.26, 95% CI 1.16–4.40. Insecticides overall gave OR 1.28, 95% CI 0.96–1.72 and impregnating agents OR 1.57, 95% CI 1.07–2.30. Results are also presented for different entities of NHL. In conclusion our study confirmed an association between exposure to phenoxyacetic acids and NHL and the association with glyphosate was considerably strengthened”.

NB The association is strengthened. Again this is significant association, but not proof of a causal mechanism (ie more research required)

14. De Roos, AJ, Zahm, SH, Cantor, KP et al. Integrative assessment of multiple pesticides as risk factors for non-Hodgkin's lymphoma among men. Occup Environ Med. 2003; 60: E11 Abstract said:

“Results: Reported use of several individual pesticides was associated with increased NHL incidence, including organophosphate insecticides coumaphos, diazinon, and fonofos, insecticides chlordane, dieldrin, and copper acetoarsenite, and herbicides atrazine, glyphosate, and sodium chlorate. A subanalysis of these "potentially carcinogenic" pesticides suggested a positive trend of risk with exposure to increasing numbers.

Conclusion: Consideration of multiple exposures is important in accurately estimating specific effects and in evaluating realistic exposure scenarios.”

NB The conclusion was that glyphosate was just one of nine most ‘potential carcinogen’. Why is it picked out by IARC? I would go for the Organophosphates, as their mechanism of action is more in tune with what goes wrong in NHL. By diverting attention to glyphosate, maybe overlooking other important candidates.


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