Environment & Regulations

Hazard & risk in focus

Dr Ragnar Loftstedt of the Kings Centre for Risk Management at King's College London looks at how to strike a balance between risk and hazard when adopting legislation

In Europe, debate as to whether one should regulate chemicals based on intrinsic hazard - in other words, one that determines a substance's potential to cause harm - or assessment of risk, which studies the likelihood (and the severity) of that substance to actually cause harm, has been gaining momentum. Some member states (MSs) and environmental NGOs argue for hazard-based regulations, while other MSs view risk assessment as an essential part of the risk management process.

Those favouring hazard-based regulations argue that risk assessments are complex, non-scientific, costly and based on different methodologies that can produce different outcomes. Those favouring risk assessment advocate the use of science-based tools and argue against hazard classification, which they see as decisions based on assumptions rather than testing, in this way making them quicker and cheaper to carry out.

My new paper 'Risk versus Hazard - How to Regulate in the 21st Century' addresses the use of science-based risk analysis tools among the various European and national bodies and their views on the use of risk vis-à-vis hazard. It also considers which European regulators favour risk assessment and regulatory trends in the environment and food area. It is based on interviews carried out in eight MSs with regulators, academics, policy makers, industry representatives and European Commission (EC) officials between April and November 2010.

In order to determine the different views on the use of risk vis-à-vis hazard, the paper considers two European case studies which consider the handling of two chemical compounds: the ban of bisphenol A (BPA) from 2011 and the partial phase-out of the brominated flame retardant decaBDE.

In both cases, Scandinavian influence was prominent. Studies carried out on the substances led to media interest and rising public concern, pressure from NGOs mounted and the issues became political. Similarly in both examples, hazard was used to justify a ban of the substances.

In the case of BPA, Denmark initiated action by putting forward a temporary national ban on BPA in materials that come into contact with food for children under three years of age. A ban on BPA in plastic baby bottles followed at EU level. Denmark and other Scandinavian countries also led the way in having decaBDE banned in electrical and electronic equipment.

The success of Scandinavian countries to pressure other MSs for Europe-wide bans can be attributed to a few factors: a higher level of public credibility in environmental regulators rather than industry - brought on by the view that industry has a vested interest in its own products rather than the public's best interest at heart - and the growing public perception of chemicals as bad, which is being amplified by the media and highly publicised campaigns against chemicals.

BPA in babies' bottles and decaBDE in electronic equipment have been perennial bones of contention

The two cases also highlight the different cultural views, values and ideas held among MSs regarding regulations based on risk versus hazard and the significant inconsistencies in the application of risk and hazard assessments for regulation setting throughout Europe. At present, various actors at MS and European level are pushing their own views and opinions on how best to regulate, resulting in the passing of bans or directives and regulations that are at times hazard-based and at other times risk-based.

Inconsistencies in the application of risk and hazard assessments for regulation can be due to various factors, such as politicians choosing to support only those bans which do not affect the economic well-being of their country. Also, according to Dave Bench, director of science, engineering, analysis and chemicals regulation at the UK's Health & Safety Executive, the use of hazard-based legislation has been popular in Europe because it is politically expedient and perhaps easier to explain.  

A series of expert panel workshops has taken place across Europe, which have been drawing attention to the risk versus hazard debate. Some key points arising from these workshops have been the ongoing confusion between the terms 'risk' and 'hazard' and reporting by media which often refers to 'hazard' when what is actually meant is 'risk'.

A recent panel at the Centre for Socio-Legal Studies at the University of Oxford on 'Risk versus Hazard: Hypocrisy in Policy' focused on this ongoing confusion with terminology. Here, I put forward suggestions to develop media guidelines to ensure that journalists become better communicators of risk, science and uncertainty as well as the need for a better 'European-led' understanding of what is meant by risk assessment and risk as a whole.

Various other aspects of the debate were also discussed at Oxford with respect to risk versus hazard in European legislation, UK-based case law and British health and safety regulation. Mark Tyler, a solicitor at Shook, Hardy & Bacon highlighted how UK case law has repeatedly defined risk as the "possibility of danger" rather than a combination of the likelihood of harm occurring.

There is also a need for an effective risk-management system in health and safety regulations to prevent injury and death. Lynda Armstrong, chair of the British Safety Council (BSC) stressed the need for a clear legal framework that is proportional, respected and effective. Furthermore, the implementation of such legislation should be carried out with a proper understanding of the individual business. The BSC carries out regular audits which are a useful tool to help businesses improve their risk management.

The recent EU pesticide regulation is a further example of confusion between risk and hazard and the removal of substances from the market without carrying out proper risk assessments. UK authorities did not agree with the scope of the EU's impact assessment and questioned legislation which banned substances without a proper risk evaluation and decided to produce a risk-based impact assessment to determine the consequences of removing a substance from the market.

The balance of risk and hazard was discussed in depth at the Oxford conference

According to Bench, the consequent European debate that followed led to the drafting of a better piece of legislation. In relation to this, he highlighted the danger of substituting one particular substance for another which had not been thoroughly assessed and which could potentially lead to an increase in risk in a different area.

Risk-risk trade-off is a key point raised in my paper that is relevant to the two case studies mentioned above This occurs when a regulator focuses on decreasing one specific risk and unintentionally increases a risk elsewhere in the process. Regulators across the world have often ignored and do still frequently ignore this issue. Both of the aforementioned case studies have risk-risk trade-offs.

In the case of BPA, replacing BPA plastic baby bottles with glass ones could result in the problems associated with consequences of breakage and many manufacturers have found it difficult to find suitable alternatives that have also been tested and researched to the same degree as BPA. In the case of the ban on decaBDE, meanwhile, few studies demonstrating the consequences of the ban in terms of increased fires in appliances had been carried out and alternatives to decaBDE, such as phosphorus-based compounds, had not been equally studied.

Where regulation is rushed, possible unintended consequences are not taken into account. More serious still, the power of EU decision-making is shifting from the EC towards the European Parliament, whose members are more influenced by their personal world views and cultural norms, than by properly researched scientific evidence.

What is needed now is a fundamental re-think of European risk policy to ensure that, as we go forward, it is based on the best available science. The workshops across Europe have been drawing attention to the different approaches to risk and hazard in regulatory decision-making and it is hoped that the debate will feed into future thinking about the 2012 REACH review and a possible review of the EC's Communication on the Precautionary Principle.

Recommendations include the need to establish a non-partisan and well resourced scientific advisory board in the European Parliament to examine and analyse the policies that MEPs are voting on. Decisions based on hazard assessments are simpler - and, in comparison to the US House of Representatives, the European Parliament is under-resourced, with little scientific expertise available.

There is also some urgency to develop a wide array of non-partisan, science-based risk analysis principles that are both agreed on and used by the majority of the MEPs. Without proper science-based assessments of substances, Europe may run the risk of restricting and banning essential everyday products with little or no justification other than emotion and instinctive suspicion.

Further recommendations to ensure more scientific and risk-based Europe-wide policy making include: highlighting the importance of education in this area, improving risk communication among regulators, creating an independent academic expert group and establishing a peer group of interested regulators, academics and stakeholders.

 

 

From Online Issue: December 2011