Regulatory Science 101: Risk Assessments vs. EU-Style Hazard Assessments

Published June 23, 2019

Can we ever be “too safe?” Before answering that question, consider that in an effort to make the world around us ever-safer, we sometimes tend to ignore unintended tradeoffs with potentially worse consequences than the dangers we are trying to avoid.

Bye-Bye, Kids’ ATVs

After the federal Consumer Product Safety Improvement Act became law in 2008, dirt bikes and ATVs designed for kids were forced off the market because their batteries contained lead. These kid-friendly vehicles were smaller, lighter, and less powerful than adult models, providing significant safety benefits. I know, because I learned to ride a Honda SL-80 safely when I was ten years old.

Granted, it wasn’t the safest activity for a child, but none of the risks emanated from the likelihood I’d open up the battery and chew on it.

While consuming lead poses a significant health hazard, my risk of exposure to that hazard was nil, because it wasn’t something I—or anyone—would have chewed on. The elimination of a hazard where there was no risk ended up increasing the risk of hazardous injury to youths by causing them ride vehicles that are too big and heavy for them. 

Hazard vs. Risk

Understanding the distinction between hazard and risk is critical in ensuring not only products for children but also things we use daily are safe for humans and the environment.

A given chemical could be hazardous—having the potential to cause harm—but if the risk of exposure to dangerous levels of the chemical is insignificant, regulating its use can be harmful, as when it unnecessarily removes products (like my dirt bike) from the market.

The bipartisan 2016 Frank Lautenberg Chemical Safety for the 21st Century Act, which updated federal chemical safety laws, took this into account. It requires the U.S. Environmental Protection Agency (EPA) to use risk-based assessments in evaluating chemicals. This is a more sensible approach than the hazard-based assessments still used in the European Union (EU).

Risk-based assessments allow us to safely benefit from a broader array of products, allowing us to avoid harmful exposures without casting a broad regulatory net lacking commensurate safety gains.

‘Turn Back the Clock’

As federal chemical oversight has become more comprehensive and reliable, powerful fringe groups are targeting state legislators, hoping to advance an agenda that plays well in sound bites though it lacks any basis in science.

These activists are seeking to turn back the clock on advances in regulatory science by lobbying states to enact laws requiring small state agencies to develop lists of allegedly dangerous chemicals based not on risk but on hazard.

For instance, legislation passed in Albany in April requires the New York State Department of Environmental Conservation to develop a list of “dangerous” chemicals that would then be de facto banned in new children’s toys. This, despite the fact federal law already requires the EPA to comprehensively evaluate existing chemicals.

New York’s law will limit consumers’ choices and harm New York businesses without providing any actual protection, because federal scientists already have the mandate, expertise, equipment, and funding to do this complex and important work properly. The same cannot be said for state agencies like New York’s, let alone those in Maine, Vermont, and Washington State, where similar legislation has either passed or is advancing.

Compiling such lists wastes precious resources and will set back progress by restricting useful chemicals that don’t pose risks. We can learn from the fallout from California’s 1986 chemical listing law known as Proposition 65. That regulatory monstrosity most recently earned embarrassing headlines when it was almost successfully used to require cancer warning labels at coffee shops.

Assessing the Risk of Silicones

Chemicals, like those that make up coffee, can be added to the Proposition 65 list simply because some authority somewhere once deemed them a hazard. Chemical regulation proposals before many state legislatures today are similarly flawed.

Consider the treatment of a class of chemicals called siloxanes: essential building blocks for silicones which are critical to much of modern society. Certain unique properties, which make them essential for safe aviation, energy-efficient LED lighting, and medical products, have caused some to question silicones’ effect on the environment. For instance, do they bioaccumulate and therefore pose a risk to aquatic life?

Canada’s version of the EPA—Environment and Climate Change Canada—performed a comprehensive risk assessment for Siloxane D5, determining “it is virtually impossible for Siloxane D5 to occur in any environmental matrix at concentrations sufficient to produce harm to the environment.” An Australian evaluation later reached a similar conclusion, and the U.S. EPA is currently performing its own risk assessment.

By using the American, Australian, or Canadian approach to risk assessment, Siloxane D5 and other critically important chemical building blocks of our modern world will be regulated to protect human health and the environment but will remain available.

EU Standards Reduce Safety

Pressured by activists, the EU imposed a hazard-based approach to chemical regulation, resulting in many important and safe chemicals being unnecessarily restricted there.

The lists of dangerous chemicals, pushed by chemophobic environmental activists, being developed by states are pernicious because they ignore federal risk assessments, instead using outmoded hazard assessments with the goal of imposing overly restrictive EU-style chemical bans.

Regulations should be based on scientific assessment of the risks of exposure to a chemical or product, not simply a hazard assessment. Using the latter standard will make society worse off and actually make us less safe.

Jeff Stier ([email protected]) is a senior fellow at the Consumer Choice Center and a policy advisor to The Heartland Institute.