Is Europe going to switch from risk based regulation?

If you are serious about understanding chemical regulation, you’ll read Cass Sunstein’s ‘Risk and Reason: Safety, Environment and the Law’ (link).

For reasons unclear to me, Cass Sunstein is not known by many risk regulators in Europe. That is a shame. They’d learn a lot from reading him. He is more informative than a tweet.

After all, you can not eliminate all risks from substances.  Just banning a substance because it is hazardous may make some people feel good. But, banning something before looking at the risks involved and doing a cost-benefit analysis will do little to nothing to help public health.

Some risk regulators seem to reject the basic idea of cost-benefit analysis. This is despite it being explicitly called for in the Commission’s own Better Regulation rule book.

The reality is that there is nothing that we breathe, eat, and drink without encountering hazards (including carcinogens). They are divided between man-made (synthetic) and natural substances. You can’t avoid them. Radiation exists in nature and it is man-made.   Harmful levels can be found in nature just as they can be found in life-saving radiation treatment or nuclear energy. Every time you take a glass of alcohol, you are taking a risk, a risk that many people take every day.

 

How to deal with risk

For a long time,  Europe’s basic approach to the regulation of chemical substances is risk regulation.

Risk analysis is based on the following stages:

 

  1. Hazard characterization – identifies adverse effects posed by exposure.
  2. Dose-response – quantifies the relationship between dose and effect.e – dose-response curves exist for most substances.
  3. Exposure Assessment – assess exposure pathways, outcomes, and populations.
  4. Risk Characterisation – integrate 1,2, and 3 and generate an estimate of the overall risk to human or environmental health.
  5. If necessary, appropriate risk management measures to best protect human and environmental health.

 

Exceptions to the general rule

There are some exceptions to this general rule. Today, a distinction is made between those substances that are presumed to be hazardous and those that are deemed to be generally safe.

For some areas, the legislator has reversed the burden of proof. Then the substance is deemed to be hazardous until proved otherwise. This is the approach taken for biocides, pesticides, and plastic materials coming into contact with food material.

The hazard is that some substances become politically unpopular. The desire to phase them out, despite the evidence, can become politically unstoppable. An innocent phrase in a scientific report can be taken out of context to back a ban. After all, nearly everything we breathe, eat, and drink has some risk associated with it. And,  politicians and officials will quietly un-ban or change the measure when they aware that the substance was needed to produce life-saving medicine or vital applications.

In the upcoming review of chemical legislation, the extent to which risk regulation remains the general rule of thumb will come up.

One can only hope that 27 Environment Ministers and 704 MEPs read Cass Sunstein before they make any decisions.