By Grant Jacobs 13/08/2018 14


A lot has been said about a recent court case ruling about Monsanto’s Roundup. Let’s look just at the role of IARC and Eugenie Sage’s call for the New Zealand Environment Protection Agency (NZ EPA) review their stance on Roundup.

The role IARC seems to be very little understood. Many media reports (worldwide) on this court case offer a throw-away statement that the IARC report and regulatory rulings conflict.

They are not in competition. The regulatory bodies have not “set aside” or “overlooked” the IARC findings. (That’s a lobby-group line.)

In practice, regulatory bodies are using the IARC reports as they are meant to.

This seems to have confused by objections to IARC’s findings, a parallel issue.

Adding to the mix, in New Zealand the Associate Environment Minister, Eugenie Sage, has said she will ask the NZ EPA to consider declaring Monsanto’s weed-killer, Roundup, hazardous.1

The NZ EPA has already reviewed IARC’s report on their own initiative in 2016, and the court case does not appear to be centred around new safety evidence. This would suggest there is nothing further to be done.

IARC reports, and how they wish them to be used

IARC published their monograph on glyphosate in 2015. Regulatory agencies have re-examined their stance with it in mind. These steps are not either/or. They are one then the other.

It’s IARC step 1; regulatory agencies step 2.2

The throw-away statements in media reports give the impression they are competing. They aren’t.

IARC gives a heads-up as to what substances ‘might’ be hazards. It is for regulatory bodies to take this and decide where risks—if any—might lie, and how manage this.

As far as I know, every scientific regulatory agency (in the world) has cleared glyphosate for use.

The regulatory agencies have taken the IARC alert, examined where risks might lie, and confirmed it can be used.

There are a few political organisations that have over-ruled these.

Three different, sequential steps. Advisory on hazards. Regulatory on risks. Political on, what I can say? (Too often: emotive appeal, political correctness or possibly political ‘convenience’, pandering to loud voices, etc.?)

What the IARC says is their role

This description of the IARC role above isn’t my opinion, it’s how IARC describe their role themselves.

Speaking to an U.S. House Science, Space, and Technology Committee’s Subcommittee on Environment hearing on the IARC 2015 glyphosate evaluation, IARC Director Christopher Wild is reported have said,

“IARC defers risk assessment and risk management to national and international bodies, restricting itself to provision of hazard identification as a scientific foundation to those subsequent steps,” Wild added.

You may or may not agree with IARC’s report on glyphosate (I’ve read it, and feel it has some problems), but regardless of that how their work is to be used should be described accurately.

Their intention is to alert scientific regulatory bodies of compounds they might further examine for risk.

IARC role is advisory. They do not offer a “rule” to be used a public measure. Their work is for scientific advisory groups to take up.

It is the regulatory bodies that offer ‘rules’ or guidelines for public use. All regulatory bodies that have reviewed evidence in light of the IARC monograph have continued to support the use of glyphosate-based herbicides.

It seems to me that this limitation of IARC’s role it also directly implies that IARC’s ruling, taken on it’s own, cannot serve as ’evidence’ of glyphosate causing harm. (It is an invitation to further assessment for regulatory purposes, not an offering of risk assessment or public ruling.)

Indeed, the Daubert ruling of Federal District Judge Chhabria noted similarly,

(Source: https://twitter.com/southernmike1/status/1028245621399056384, in a tweet stream unrolled here. Note this is for a federal court: the court case in the current headlines is a civil case.)

More generally IARC rulings are, by their nature, not really suitable for direct-to-public use as they do not establish where possible risk might lie.

For that, you need to look at risks, not hazards (and use regulatory bodies).

Hazards and risks

IARC reports possible hazards: things that in some setting, in some amount, in some way might cause cancer.3 (Some object to how IARC have done their analysis. Here we’re looking at the overall ‘arc’ of how their reports are used.)

Something maybe a hazard, but no risk if you are not exposed to the substance.

Similarly, there may be no risk if the dose is small. It is the dose that makes the poison: things toxic at higher doses will typically have little or no effect at low doses.

Regulatory bodies have taken note of IARC’s hazard call for glyphosate, and looked at evidence related to who is exposed, in what amounts.

They’ve decided in what if any settings are an issue for the general public, and, if any are present, how this might be mitigated. Generalising and simplifying, these note the low toxicity of glyphosate, and note any concern, if present, is limited to high doses or chronic exposure, and note issues for aquatic wildlife.

This is what the NZ EPA has done in response to the IARC report. They commissioned a report on the risks, including drawing on IARC’s hazard report. That’s how IARC would like their work to be used. It’s not ‘competing’ with it, it’s following on from it, drawing on it. One, then the other.

Eugenie Sage’s call

Her call to revise the status of Roundup looks to be a political exercise. In my opinion it would be fruitless, and time-wasting.

She’d want to first show that the court case introduces new safety evidence. My understanding (so far) is that it doesn’t.

It presumes the jury calling is sound and has weight. That a jury has called what they have doesn’t suddenly make it unsafe. It can just as equally say the jury called poorly. Many scientists worldwide have pointed this out.

Monsanto has said they will appeal the ruling. The legal matter is still in limbo.

The focus on Roundup is problematic. It falls for the political lobbying game, not the actual safety issues. Safety issues are related to the chemicals used, not a particular product or brand.

It’s doubly problematic as there has been a focus on Monsanto, the company that makes Roundup, as a straw-man substitute lobbying target. Roundup is a product of that company. The key ingredient, glyphosate, is widely used by many other companies, in a range of formulations.

Some might suggest it’s attention-grabbing, and an opportunistic move.

In any event the NZ EPA has already reviewed the evidence recently and cleared glyphosate-based products for use.

Postscript: The USA court ruling

It’s a jury’s call, made in an adversarial setting.

It’s clear to most scientists that a number of prominent court cases fly in the face of the science at hand. What is causing this, and what might work better?

I’m not a lawyer, and I don’t have an answer at hand, but it is the question that I get from this case.

The use of juries in complex cases will again be questioned.

I’ve previously suggested adversarial approaches are a poor way of dealing with science.

Another concern is precedent.

I may return to this. A number of people are implying that this ruling ‘proves’ glyphosate is unsafe.

It does not.

What it mostly highlights is how poor (jury-deliberated) courts can be at scientific matters.

Footnotes

  1. In practice I’m skeptical you can call for this one product to singled out like this. I’d think you’d have to look at the class of products it falls within, not the brand.
  2. To be fair, regulatory agencies in principle could elect to ignore the IARC ruling. As far as I know, none have. This is not surprising as the IARC monograph condenses a lot of information that might be useful in determining risk.
  3. A second point I’ve left out for simplicity is that the “probable” that the IARC refers to is NOT the likelihood of glyphosate causing cancer—as it is so often misreported—but the likelihood of the evidence examined in their study correctly calls that there is some kind of hazard present. (Furthermore, IARC will call a hazard even if there is competing evidence suggesting no hazard. They advise on that there is some evidence there a hazard.)

Other articles in Code for life

Regulating GMOs: time to move forward (Key point to frame discussion.)

Green Party GM policy and discussion about GE or GMOs (The NZ Green Party should revise their stance on GM.)

Genetic modification now accepted by most New Zealanders (A survey indicates New Zealanders now accept GM food as safe.)

Is GM corn really different to non-GM corn? (Reporting other’s objections to one controversy.)

Séralini GMO maize and Roundup study republished with no scientific peer review (One of the ‘unorthodox’ researchers opposing GMOs re-publishes a retracted paper with no fresh peer-review.)

Kumara are transgenic (Transgenes occur in nature too.)

About the featured image

The image is cropped from that held on Wikipedia (Creative Commons Attribution-Share Alike 2.0 Generic license).

Agricultural company Monsanto has been used as a straw-man substitute for protest against GMOs. Protest against glyphosate is seen by many as an extension of this. Monsanto was recently purchased by Bayer, who are closing the Monsanto name.


14 Responses to “USA Court ruling on glyphosate— the role of IARC and Eugenie Sage’s call”

  • I noticed that there is no ‘conflict of interest’ or similar statement. The article reads as a pro-Monsanto (Bayer) editorial. If a ‘conflict of interest’ does not exist, perhaps the writer can run some algorithms on the likelihood of Roundup (the finished product, which includes additives and Glyphosate) being a culprit in increased cancer risk. If there is any possibility of a conflict of interest with Monsanto (which now includes Bayer as well), the article has no value, nor does the running of any algorithms. It appears that most scientists are either bought by Monsanto, or are afraid of going against that company for fear of potentially losing out on valuable work in the future. The latter comment also applies to most other multi-national chemical companies.

    • Strange that you say my piece reads as “pro-Monsanto” when my piece barely makes comment about Monsanto at all.

      It appears that most scientists are either bought by Monsanto, or are afraid of going against that company for fear of potentially losing out on valuable work in the future.

      In practice this is (exceptionally) unlikely. Most scientists are horribly independent and it’s nearly impossible to tell them what to say. Anyone who has worked in an academic setting will tell you that.

      Also, few scientists depend on the likes of Monsanto for funding. Most people are funded from government grants, or, much less commonly, from charities. (Few charities have much funding to offer.) As an aside, it’s worth bearing in mind that there are a few are dependent on funding from the ‘organic’ industry or similar interests. If you’re going to object to those that have industry funding, to be consistent you’ll have to object to those funded from these interests, too.

      In my case I’m an independent scientific consultant, as can easily be learnt with a little effort. This independence, along with a long background in molecular biology, leaves me in a useful position to comment on otherwise contentious topics.

      I’ve never received any money from anyone for any of my writing at Sciblogs. Zip, nada, nil.

      My article actually deals with how IARC reports are used (as opposed to how IARC’s role has loosely been described in most media reports), how that relates to regulatory bodies (including the NZ EPA), and how that in turn relates to Eugenie Sage’s call. None of that has much to do with Monsanto.

      perhaps the writer can run some algorithms on the likelihood of Roundup (the finished product, which includes additives and Glyphosate) being a culprit in increased cancer risk

      Not my bailiwick, and not really possible in the way that you mean. Sorry, but one day in a science-fiction future!

      Biological systems are a little more complex than simple simple algorithms (!). While there is some pretty interesting modelling work out there, there are no modelling systems that model the human body at that sort of level, not even small ‘model organism’ animals for that matter. There are some narrowly focused models on small subsets of patterning genes, for example, but not all the chemistry of whole bodies, which is just a dream right now. As I was saying, one day in a science-fiction future.

      Also there’s that practical thing that consultants generally don’t work for free. Nor do freelance writers for that matter.

      — Cheers.

      PS: A few general words on the “shill” gambit, which your comment runs awfully close to —-

      Suggesting someone is a “shill” is one of the weakest things to offer as it has the commenter opening with a personal slight, and a strawman, rather than engaging with the points made, and it’s a crude attempt to dismiss the points made out-of-hand. It can also suggest the commenter didn’t read the article.

      I’ve a general rule of thumb: personal slights are the argument of last resort, and if someone opens with the argument of last resort, it tactically implies they have no substantive argument to offer.

  • Dave,

    I probably should find time to do a piece on just risk v hazard, so that I can point to it when I need to in future.

    There’s quite a lot else to be said, too. The relative toxicity of glyphosate (it’s low, about the same or lower than the caffeine in people’s coffee). The nature of NHL. Outside my expertise, but important: what the court actually asked of the jury (not to ‘prove’ that glyphosate caused Johnson’s cancer, but that it plausibly might have; that makes the ruling not of much use from a regulatory point of view). And so on.

    It’s unlikely I’ll cover it all, unless I got a paid opportunity to write about it. (Editors, etc.: enquiries welcome!)

  • Those wanting further reading on glyphosate v non-Hodgkin lymphoma (NHL), and cancer in general, may like this blog post by weed scientist Andrew Kniss that looks at the risk assessments that have been done. It gives a good idea of the issues involved in a clearly-written piece –

    https://plantoutofplace.com/2018/08/glyphosate-and-cancer-revisited/

    The final plot is striking. Risk usually varies with dose, higher dose, higher association (as I noted in my piece). Instead, all of the point estimates were less than one irrespective of dose. That would indicate glyphosate isn’t linked to NHL risk.

  • The IARC ruling was dodgy to say the least:
    https://www.reuters.com/article/us-who-iarc-glyphosate-specialreport/in-glyphosate-review-who-cancer-agency-edited-out-non-carcinogenic-findings-idUSKBN1CO251
    It would be interesting to know if any of the IARC people were involved with the plaintiffs in the court case. One of the plaintiff’s lead lawyers, RFK Jr, is a prominent anti-vaxxer
    https://www.scientificamerican.com/article/how-robert-f-kennedy-jr-distorted-vaccine-science1/
    so the case wasn’t about the science

    • Chris Portier, who was an advisor appointed on the IARC team that wrote the glyphosate monograph, is one of the experts called by the prosecution. Portier also chaired the committee that proposed the glyphosate study. There’s a lot said about that elsewhere. They raise important points, but at the same time you need to be careful they’re not over-played. I think the deeper issue is how organisations (IARC in this case) mitigate against with these things, and deal with them if/when they arise.

      I’m not against using people who contributed to these reports as experts, but how you do it matters.

      A couple of things I’ve read elsewhere –

      One concern is that Portier was bound to a non-disclosure agreement (NDA) for a time. Some argue that a consequence is that he spoke at a number of forums without openly declaring a possible conflict of interest. NDAs need to be treated with care, and impacts on other work (say, public presentations & advisory services) treated seriously.

      Another is that he signed onto the legal team immediately as the IARC monograph was released. The potential implication is that the negotiations for him to be part of the legal team took place while he was working on the IARC monograph.

      Another possibility is some working on reports being influenced from outside activities (not pointing fingers at anyone here, just making a general observation). I suspect this is more wide-spread than people think, across all sorts of reports. (Check out my take on the glyphosate report them Green Party MP Stefan Browning commissioned. In that case, the entire report was framed to serve up a desired answer!)

      One option that has occurred to me is for IARC to impose a stand-down period for their experts to act as legal advisors or ‘court experts’ to avoid this sort of conflict (or speculations of it).

      Another that I’ve considered is for consultants (like myself) to have an appendix to the report listing all people who tried to influence them during the work of a report.

      As for editing the report, I have a few thoughts about that too. Ideally you’d not revise individual judgements of each study, once that’s done. The subsequent steps can openly indicate if that a particular report was felt to be of less merit, etc., if really needed, but this ought not to be done by ‘revisionist’ editing. There’s more to this & I have to get to other things (sorry).

  • There are a number of disturbing studies showing global decline of insect biomass. Impact on human health is important, for sure, but what about impact on ecological health (to which we are all tied)?

    https://www.nytimes.com/2018/05/26/opinion/sunday/insects-bugs-naturalists-scientists.html

    A number of countries have moved to ban or severely restrict glyphosate use. It is time for NZ to take this seriously.

    https://www.baumhedlundlaw.com/toxic-tort-law/monsanto-roundup-lawsuit/where-is-glyphosate-banned/

    • The NY Times piece doesn’t mention glyphosate. The two points the writer makes are (1) “we don’t know what’s causing this”, and (2) “we’re useful, please give us a job!”

      That other countries have enacted some policy isn’t a good argument for us to. I don’t think much of ‘copycat politics’ done ‘just because’ some other place did. What matters are the reasons behind why you might. As I note in my article, some political bodies have ruled over the top of regulatory or scientific advice. Usually that’s a bad idea, and can reflect weak or poor governance. (Sometimes it’s because rather than tackle the education needed, governments prefer the easier option. It’s like NZ’s GMO law: the government of the day picked the softest option. Good governance, in my opinion, includes standing up for the well-advised recommendations even if a few “loud voices” say otherwise.)

      Bear in mind that the NZ EPA has already reviewed the evidence in light of IARC’s report, as my piece notes.

  • It looks likely that Monsanto is to get a new trial for the case: http://news.trust.org/item/20181010212103-pgppw/

    The Guardian has also reported on this, more in the line that it’s more-or-less a ‘done deal’: https://www.theguardian.com/business/2018/oct/10/monsanto-cancer-trial-weedkiller-challenge-dewayne-johnson

    Hopefully I’ll find time to put the work I’ve done reading (some of) the court transcripts, etc., as thoughts on what a new trial might consider.

  • One more: any journalists or editors reading this please take especial note:

    Both the articles I linked to in my previous comment have the court case ‘finding’ that glyphosate ‘caused’ Johnson’s cancer.

    The court not only cannot do this; even the prosecutor said they can’t in his opening address.

    It’s possible both goofs lie in the hands of a sub-editor, as both are in the lede. (The opening paragraph—as well as the header—are typically written by a sub-editor rather than the journalist who wrote the body of the story. The sub-eds add attention-grabbing lines, etc. A suggestion I’ve made elsewhere on my blog is that having gotten your attention, you’re best to mentally discard the header and lede.)

  • I’m not a lawyer (IANAL, as they say) but I’ve read the judge’s Tentative Ruling, and I’ve got to say it looks damning. Still, we get to wait and see what transpires.

    Parts I, II.1 and II.2 of the Tentative Ruling look unequivocal to me, and the prosecution lawyer’s actions described in part II.4 were bad enough to be called out and now are being questioned as to if they ultimately adversely affected the verdict. I’ve no idea what part II.3 specifically refers to (the ruling doesn’t make it clear), and part II.5 is simply outside my bailiwick, being about USA law itself.

    More on this later, maybe. Meantime a few of the ‘usual’ people opposed to glyphosate are being noisy at me elsewhere on social media 🙁

    One thing that increasingly bothers me is that this is all very unhelpful for cancer patients.