Unravelling Evidence Based Policy & Industry Managed Risk Assessment

When we consider evidence based policy – perhaps we should consider the origins of the ‘evidence’ policy makers use in decision making. Shouldn't resultant policy be based on unbiased scientifically credible information that is free from conflicts of interest?

It appears that 'evidence based policy' is useful - as long as it acts for the benefit of establishing certainty in narrow disciplinary fields (silos). 'Evidence based policy' has not been harnessed effectively in the wider realm of risk assessment relating to the public interest. The evidence to establish risk of adverse effects from a given exposure (for example), in the public interest, need not require certainty, more probability that adverse harm will occur across a range of risk scenarios.

In the paper by Brownson et al 2009 the authors state ‘Policy change involves both science and art and, therefore, evidence for policy-making can take several forms. The concept of evidence often originates from legal settings in Western societies. In law, evidence comes in the form of stories, witness accounts, police testimony, expert opinions, and forensic science.  For policy-relevant evidence, both quantitative data (e.g., epidemiological) and qualitative information (e.g., narrative accounts) are important.’

The authors noted that there is no single, ‘best’ type of evidence and that ‘evidence-based policy is developed through a continuous process that uses the best available quantitative and qualitative evidence’.

To date, the science - and hence the information we base our evidence on -  that establishes exposure levels for pesticides and confirms safety of genetically modified crops (most of which are herbicide tolerant and treated post emergence with herbicides) are industry, rather than regulator selected. There is a fundamental conflict in the way this risk assessment is carried out. Critical decisions are based on core data that comprises, essentially, a narrow range of unpublished and private studies.  

These studies are kept secret from public scrutiny by ‘trade secrets’ or commercial confidentiality agreements that protect the interests of industry. Inclusion of published literature that may show harm at lower, more delicate levels are ignored or excluded by regulators who frequently dismiss studies that do not sit within narrow industry guidelines.

So what good is ‘evidence based science’ if it cleverly excludes independently published science and limits risk to one component of a chemical formulation? Does this act in the best interests of the environment or human population?

There is good data and bad data – both will be produced by industry and independent scientists alike – but as of 2016, internationally, industry data is exclusively used to establish pesticide exposure levels. It's a rigged system.

Glyphosate is the most pervasive pesticide in use today, applied to city streets, rainwater drains, throughout parks; on soils to control weeds, but perhaps most worryingly, it is applied across a wide range of human food crops (genetically modified and conventional). Recently the WHO International Agency for Research on Cancer (IARC) conducted what much of industry and our regulators are referring to as a ‘hazard assessment’ rather than a ‘risk assessment.’ The IARC did not establish the level at which glyphosate would be harmful – such as a dose that would cause harm – the IARC simply concluded that glyphosate was ‘probably carcinogenic’. As a result, much of industry and many regulators are dismissing the extensive review, stating ‘IARC data does not indicate any credible risk to users of glyphosate.’

The data used for the IARC monograph was sourced from 'openly available scientific literature’ and ‘data from governmental reports that are publicly available’. It was impartial.

Does the WHO’s International Agency for Research on Cancer form a credible platform from which to form an ‘evidence based policy’ to request urgent reassessment of this ‘probable carcinogen’?  Apparently not, according to our regulators and their current advisers. It can be ignored as it was only a 'hazard assessment.'

(I note that every pesticide risk assessment undertaken is based on exposure of the chemical to a 60kg adult, rather than a week old foetus or recently arrived baby. I also note that frequently, published literature indicates harm at endocrine disrupting levels much lower than those considered within the narrow range of studies supplied by the manufacturers to our regulators. [1] There are massive data gaps in current risk assessment that have not kept up with current scientific knowledge.)

Our regulators are failing us when they dismiss the findings of the most thorough review of glyphosate carcinogenicity studies ever undertaken. Traditionally, regulatory carcinogenicity risk assessment has considered a narrow range of industry studies and used only industry data to establish NOAELs - No Observed Adverse Effect Level. US carcinogenicity reviews have to date, only considered a narrow range of industry supplied and sponsored studies. Fact.

Simply put, we require integrity in scientific decision making. We require transparency and we require decisions regarding our daily exposure load of chemicals, including glyphosate, to be unbiased and free from conflicts of interest. We need policies to protect our children from the effects at the very delicate levels that affect our endocrine systems – but which remain outliers in pesticides risk assessment in 2016. There is bucketloads of science depicting harm from pesticides to the endocrine system, to children – and from published studies demonstrating the greater harm from exposure to the full formulations sold and applied to the crops we eat.

Without integrity and impartiality, evidence based policy is disingenuous load of dross.

Sir Peter Gluckman, New Zealand’s chief science adviser wrote an article for the online journal Nature, in 2014. The article concerned the provision of science advice to government, and he listed his top ten principles, or guidelines, that guide his work.

As Sir Gluckman noted, ‘Crucially, science advisers are obliged to advise in the context of the policy process. This means elucidating the evidence-informed options, rather than simply advocating a course of action’. We can't agree more.

The second of his ten principles: ‘protect the independence of advice’ is listed from the perspective of an adviser to government – but this same requirement underpins international condemnation released almost weekly from the NGO and public health and environment sectors – that regularly challenges global regulators reliance on corporate sponsored, or manufacturer supplied science.  

Risk assessment of pesticides undertaken by the three most influential regulators, the US Environmental Protection Agency, European Food Safety Authority and the joint committee of the World Health Organisation and Food and Agriculture Organisation (the WHO/FAO JMPR) influences government decision making internationally.

These regulators routinely use unpublished seller selected and sponsored studies to provide the NOAEL. This level will tend to be divided by a factor of 100 to give the ADI – acceptable daily intake. The ADI is the presumed safe level an adult can consume safely each day for the rest of his or her life. The most recent example comes out of Europe, where a recent glyphosate assessment and the following increased ADI level relied exclusively on data provided by industry.

Yes, these secret, unpublished studies are routinely supplied by the pesticides manufacturers – a significant conflict of interest. For the ADI can then be extrapolated to become recommended residue levels on individual crops – which directly links to sales of agrichemicals.

Chemical toxicity is without doubt the raging elephant in the room, and it should simply be good science to impartially research and understand the long term implications as quickly as we can. The costs of routinely testing for a chemical such as glyphosate, appear to be beyond most regulators - let alone the slow dawning that follows when we realise the consequences of rising levels in our groundwater of a chemical that regulators simply claim ‘is of low toxicity’.

Why is the biotech industry so interested in defending glyphosate? This organophosphate, that is sectioned of as a phosphanoglycine, is applied to more than 80% of GM crops, together with other chemicals the crops are additionally engineered to resist (as stacked traits). And no, the resultant GM soy, canola, sugar beet or corn (there are other crops) have never been tested for safety by regulators complete with the full formulations of the recommended herbicides these crops are specifically developed to tolerate.  And of course, to date, the safety studies for risk assessment of GMO's are exclusively provided by the, you guessed, it developer of the GMO.

Sigh. It should be about good science.

As Sir Gluckman noted in his 2011 Discussion Paper, in Section 5.3, page 14 - 'when relying on the use of external scientific advice, steps should be taken to ensure the advice is:

• focused on the data and its appropriate interpretation;

• unbiased with respect to its use of data;

• open about what is known and not known;

• able to communicate in terms of probabilities and magnitude of effect;

free from conflicts of interest, provided apolitically and independent of any particular end-user perspective.'

In discussion regarding ‘evidence based policy’ – good policy can only be developed if it comes from sound infrastructure.

As Sir Gluckman commented, policy formation ‘can involve additional political, ethical, economic and social dimensions’.

Evidence based policy should have the agility to respond to new knowledge - yet entrapment via the very industries that profit most is the current MO.

 

What use is evidence based policy if it....?

Narrowly serves the chemical’s producer

Creates a buffer or barrier that fails to consider the new (and multiple) pathways by which science now understands a commonly used chemical to be harmful.

Fails to follow the precautionary principle.

Underestimates probability in the public interest for the public. Current risk assessment policies do not assess risk of harm across a wide range of disease pathways - rather the regulator selects the 'most dangerous' pathway and simply defines risk from the one discipline.

Fails to take into account increasing knowledge regarding neonatal, prenatal, childhood and adolescent vulnerability.

Does not take into account environmentally relevant levels of exposures of complete formulations.

Cannot transparently assess industry derived data.

 

References

[1] Buonsante, V. A.; Muilerman, H.; Santos, T.; Robinson, C.; Tweedale, A. C. Risk assessment’s insensitive toxicity testing may cause it to fail. Environ. Res. 2014, 135C, 139−147