|EU-US COMPARATIVE ANALYSIS|
Better Safe than Sorry: EU tackles Endocrine Disruptors While the US Watches
The EU has for many years seen itself as a global leader when it comes to environment and health policies. In this vein, it is aiming to be the first jurisdiction in the world to set binding criteria for so-called “endocrine disruptors” – chemicals that affect humans’ hormonal balance, thought to be particularly harmful to babies and young children.
This might all sound rather niche, but these criteria have got a number of industries sitting up and taking notice including pesticides and biocides, cosmetics, toys, and food.
Why? Because once the criteria are agreed, they are likely to apply horizontally across a number of different EU laws affecting these industries, and many more. Depending on how strict the criteria are, companies may have to remove some substances from their products and reformulate the ingredients – resulting in huge costs and potential disruption to supply lines.
The age-old industry v NGO debate
After long delays, which even involved the the Commission being taken to court by Sweden for missing its own deadline for proposing the criteria, in the Summer of 2016 draft criteria were finally put on the table.
The criteria were largely based on the WHO definition of an endocrine disruptor, but did not include the concept of “potency” (which angered industry) and was limited to identifying those chemicals which are “known” to cause adverse effects (thereby angering NGOs who wanted the criteria to cover chemicals which are “presumed” to cause adverse effects as well).
NGOs have been extremely vociferous in Brussels and continue to argue that all EDCs – including those suspected of being EDCs - should be completely banned in the EU.
Industry is trying to take a more nuanced approach, for example by trying to ensure that potency is included within the criteria – but it is difficult to be nuanced when the arguments expressed in public are so highly charged.
The criteria must still be agreed by EU countries and approved by the European Parliament before they become law, but this issue illustrates how the “precautionary principle” still takes priority when it comes to lawmaking at the EU level. The precautionary principle means that if there is any doubt or unknowns around a particular chemical, then it should be banned or strictly regulated. Yet this can result in perfectly safe chemicals being taken off the market, and lead to huge costs for industry.
A divided Europe
If the EU is to be a genuine global leader in this area, it needs other jurisdictions to follow it, notably the US and China.
Yet even the EU remains hugely divided on the issue of both EDCs and the precautionary principle more generally. France and the Nordics (Sweden, Denmark, Finland) support a strict approach to EDCs, whilst other countries in Central & Eastern Europe and the UK (whilst it remains an EU member) tend to take a more business-friendly approach.
With such a divided Europe, third countries are likely to take a “wait and see” approach before committing themselves to following in the EU’s footsteps.
The View from the US - by MJ Marshall
It is readily apparent that the US is lagging behind the EU on the EDC issue. While the US Environmental Protection Agency initiated the Endocrine Disruptor Screening Programme (EDSP) some years ago, it is still only in the first phase of its endocrine screenings, which focused primarily on pesticides, but has taken several years to begin a second phase of screenings targeting chemicals. Further, the EDSP currently is in the crosshairs of the Trump administration for possible elimination, in part due to this glacial progress.
But EDSP or otherwise, and overt or not, the precautionary principle still is the approach of choice for many US federal and state regulatory agencies. This essentially empowers agencies to slap a classification on a substance by finding one study, of any level of quality and repeatability, that they can cite as claiming a concern — even if there are dozens of studies showing the contrary.
And while that might be an extreme scenario, many US agencies approach hazard and risk assessment more from a “guilty until proven innocent” approach, where the bar that industry needs to meet is variable at best, and more likely inclined to be steadily raised higher. All of which means that the public may find products being phased out that are in fact safe, and industry and the economy taxed by the absence of sound and transparent hazard assessment approaches.