Arguing about nothing? “Science-based” regulation of endocrine disruptors

July 21, 2013 at 8:35 pm | Posted in Feature Articles | 1 Comment
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In discussions about chemical regulation, calls for “science-based policy” are regularly heard in the debate around the appropriate legal and testing framework for identification and control of endocrine-disrupting chemicals (EDCs).

There is a lot riding on getting the regulation right: the risks EDCs pose to health are incompletely understood; a number of stakeholders believe the evidence points to health risks which are both serious and probable; while many of the chemicals due to be regulated are significant earners for the chemicals industry. Exactly what “science-based policy” amounts to, however, is difficult to pin down.

On the one hand, stakeholders favouring environmental interests have been arguing that a science-based approach should give weight to novel hazard data as a way of flagging for regulatory scrutiny chemicals which might be harmful (H&E #54).

On the other hand, stakeholders favouring commercial interests have been less keen on regulatory approaches which place a high burden of proof of safety before a chemical is allowed to be brought to market. Instead, the science-based approach is one based on established risks.

The difference between the positions is not their use of “science” because both use it (one acts on new research, the other on established data). The difference is in the speed of reaction to new information: one waits for the jury to come in; the other is concerned that because a great deal of harm can be done while we wait for the jury to come in (a process which can take years and even decades), then greater value should be placed on early warnings (EEA 2013).

Ultimately, this is much less a discussion than it is about whose approach is more “science-based” than it is about establishing the right time to act to prevent harm in the process of accumulating evidence, and how to make manageable that point of action, be it early or late.

There is also another, stronger way of talking about science-based policy which seems to be in use and is more difficult to untangle. This is found, for example, in the UK MEP Julie Girling’s recent call for a “balanced approach” to EU policy-making.

To give an indicator of what she means, Girling stated at a meeting describing itself as “The European Risk Summit” that a recent report by the Royal College of Obstetricians and Gynaecologists (RCOG) in the UK on chemical exposures during pregnancy (RCOG 2013) failed to meet this aim.

She said: “Any report put into the public domain should be substantiated with science,” going on to say that the parts of the RCOG report are at odds with scientific evidence, for example in their description of EDCs as non-threshold substances and by making links with disorders which Girling says are “far from proven”. (CW 13 June 2013).

Girling also believes the EU parliament votes in favour of tighter rules on endocrine disruptors and the recent ban on neonicotinoid pesticides “were taken without balanced scientific assessment” (Euractiv 12 June 2013).

Professor Anne Glover, Chief Scientific Advisor to the President of the European Commission, has voiced similar concerns about how the EU is “generating the best possible knowledge but failing to harness it for informing policy” (European Policy Centre 2013).

And there is an astonishing new attack from editors of toxicology journals, in which the current EU draft regulatory framework for EDCs is described as being assembled in “virtually complete ignorance of all well‐established and taught principles of pharmacology and toxicology” and as “based on a very small number of publications that lack the required scientific robustness needed”. (Dietrich et al 2013)

The critique bemoans “the lack of attention paid by the European Commission to the weight of scientific evidence that clearly demonstrates the presence of a threshold for non‐genotoxic compounds including EDCs” and says “any scientist familiar with the overwhelming biochemical complexity of life understands that the healthy homeostasis of an organism results from an orchestrated network of myriad thresholds for every component substance.”

Describing a decision as “being at odds with scientific evidence” is an uneasy partner to demands for balanced policy. Apart from anything, it presents science as something which is always obvious and settled, when often it is not, and suggests that the “scientific” position is the factual one, which leaves one to wonder what the opposing position is (implying, for example, that Einstein’s early papers on relativity were not scientific because they did not reflect the consensus view of the time).

Of course, everyone is entitled to think they are right, but laying claim to the facts for yourself is a special kind of appeal to authority: either your own, where you are saying your judgement is better than that of anyone who would disagree; or you are appealing to The Facts themselves, which is exactly the sort of metaphysically dodgy move for authority made when a village shaman claims special access to the local deities.

Claiming authority gets particularly awkward when both sides of the argument have substantial expertise. In the case of EDC regulation, the opinions of both the Danish and Swedish authorities are (contrary to Girling’s view) that thresholds cannot be assumed and no safe exposure thresholds for EDCs have been established. By implication, Girling is saying that the Danish and Swedish positions are unscientific.

What the Danish and Swedish authorities have said about this, answering questions after presenting at a meeting of the European Environmental Bureau on 18 June 2013, is there is in principle no reason why it should not be possible to establish a safe threshold of exposure for any given EDC; all you have to do is administer test doses in experiments over a wide enough range to detect all possible effects.

The problem is, because EDCs can have effects at low doses and can have different effects in different time windows, there become too many doses and combinations to realistically test. Besides which, low doses and windows of exposure are not currently captured in the regulatory testing regime for chemicals.

The upshot is, there is a simple practical barrier preventing us from identifying safe exposure levels for EDCs. In this context, “science-based” is not a meaningful descriptor for a position based on the pragmatics of making a decision in the absence of scientific knowledge.

The Danish and Swedish explanation for the UK’s position that EDCs can be treated as having thresholds of effect is that it comes down to the use of pesticides. Most pesticides work specifically because they are EDCs; if EDCs cannot be used, then we would have to ban most pesticides.

Some Member States, such as the UK, see themselves as being in a bind here so are trying to define EDC in such a way as to skirt this obvious internal contradiction in the regulation. Since EU regulation is supposed to be harmonised, and the legal concept of EDC is being defined in the pesticides regulation, this is unfortunately spilling over into REACH.

Another interpretation of the reasons for opposing the so-called science-based position is presented by Glover and Professor Ragnar Löfstedt of King’s College London. Glover says (European Policy Centre 2013): “What is important is to be transparent about why you are banning GM, for example whether you’re doing it for social, ethical or religious reasons, or because you simply don’t like the idea of it. But don’t say you’re doing it for lack of scientific evidence, of which there is more than enough.” Löfstedt analyses the debate in terms of countries having “pet risks” (Euractiv 10 June 2013): “Why is Sweden anti-chemicals? They can afford to do so because there is not a real chemical industry in Sweden.”

The claim here is not that the opposing position is merely scientifically misinformed, but that the science is so obvious that anyone disputing it must be doing so disingenuously. This argument has a peculiar rationality to it: if the science really is obvious, then anyone disagreeing with the “science-based” position must be lying.

Stating that opposition is disingenuous is a bold claim. Sometimes it might even be true – such as denial of harms from tobacco smoke. In the face of widespread disagreement about how to defined EDC for regulatory purposes it seems an over-simplification (and could be presented the other way around: that everyone knows EDCs have no practically-identifiable threshold, and are therefore misrepresenting their opposition as being based in scientific fact). The reality, given this is an emerging area of research and regulation, is probably just more complex than Löfstedt’s analysis allows.

Overall, there seem to be three conversations in discussion about science-based policy: one sees the policy-relevant evidence as new research to be acted on quickly; another sees the policy-relevant evidence that which is established and relatively incontrovertible; for the third it is difficult to tease out anything coherent, but it seems to be about the policy-relevant science as something issued by someone who has the authority to lay claim to the facts.

The third conversation is clearly unsatisfactory as it reduces a complex discussion about what constitutes sufficient evidence of safety for a chemical to one of authority, and gives us no provision for determining which expert is right. If it’s just about authority, why should it be Girling rather than the Swedish authorities who are the ones to be believed on EDCs?

The fundamental issue is whether or not more or less cautious outcomes produce the best overall results for society; presenting the debate as being about whose position is most science-based contributes nothing to working that out.

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  1. One of the key points in this debate concerns when to act. Decisions taken when the science is more secure (science is never certain) may lead to unacceptable damage being caused due to delay. However action taken too early may be inappropriate and also damaging as changes to the science may subsequently demonstrate. Leading edge science is frequently wrong and subsequently overturned. This means that it is essential to look at the costs (and disbenefits) of action as well as inaction.and the consequences of delay. In addition actions should never be taken unless the science is reproducible, if the data can’t be replicated it is almost certainly wrong..

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