The unreasonableness of‘ unreasonable risk’
Industry still has to manage risks that have never been properly defined, says David B. Fischer of Keller and Heckman
We are all familiar with the term‘ risk’, the chance or probability of something harmful occurring. After all, we encounter risk every day in everything we do: driving to work, climbing stairs, taking a shower and countless other activities that make up our daily lives. And we are taught from an early age how to minimise risk, such as looking both ways before crossing the street, to transform an unreasonable risk into a reasonable one.
Regulatory agencies, including the US Environmental Protection Agency( EPA), also devote significant resources to assessing and managing risks. With respect to risks posed by the chemicals we use, whether at home or in the workplace, the EPA relies on the Toxic Substances Control Act( TSCA), chief among the environmental statutes that govern chemicals in commerce.
Perhaps the most important term in TSCA is the term‘ unreasonable risk of injury to health or the environment’( or simply‘ unreasonable risk’). Under Section 6 of TSCA, the EPA evaluates the risk of existing chemicals to determine whether use of these chemicals presents‘ unreasonable risk.’
Importantly, a determination of unreasonable risk triggers risk management regulations to ensure that the chemical no longer presents unreasonable risk, as TSCA instructs the EPA to eliminate unreasonable risk to the extent necessary. And although costs are considered in determining how to eliminate unreasonable risk, at the end of the day unreasonable risk must be eliminated, even if it means severely restricting or banning the chemical substance.
Thus, knowing what is and is not unreasonable risk has significant economic consequences for entire industries. Overshooting what is viewed as unreasonable risk will lead to unnecessary and costly risk mitigation measures that can ripple through the entire economy, but with little benefit.
A failure to define
Yet, in passing TSCA in 1976 and even in substantively amending the statute 40 years later in 2016, Congress opted not to define the term. Legislative history that accompanied the 2016 amendments, however, makes clear that unreasonable cannot be zero risk and that some risks are in fact reasonable.
Not to be outdone by Congress, the EPA avoided proposing a definition three times in three separate rulemakings involving the risk evaluation procedural rule( Framework Rule), in which it spells out how it will conduct risk evaluations of existing chemicals. In the most recent Framework Rule proposal,
50 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981