Regulating New Substances

Balancing the risks and benefits from the use of existing and new substances can be difficult. Defining the level of information required to approve a substance’s use brings up several complex issues. Additionally, determining who should be responsible for the costs associated with the collection and analysis of information can often lead to even larger challenges. Regulators should aim at making information collection requirements more efficient and require businesses to bear the cost of those activities.

Determining the appropriate level of regulation that balances risks and benefits involves large amounts of time and money. Researching the tens of thousands of chemicals currently in use can take decades and billions of dollars. Testing costs may outweigh the benefit that society gets from the use of the substances (Salzman and Thompson 2019, 213). The time and costs to analyze the risks and benefits of each substance can also lead to even longer delays and expenses. Risk and benefit analyses also create comparability issues regarding whether economic or moral concerns are more important (Salzman and Thompson 2019, 227).

Using known information to categorize substances into risk categories can be helpful. While there may still be scientific uncertainty, each substance has different levels of risk and uncertainty. Substances that have higher levels of risk should have higher information requirements than those with lower levels of risk. This helps reduce the costs and time delays of testing and information collection. Substances with lower levels of risk should still be labeled in a manner that states the risk and uncertainty categories similar to how California’s Proposition 65 does to help provide consumers with information to help them make informed decisions.

Determining who should pay for the collection and analysis of that information can run into complications. While the burden of evidence of exposure safety should be placed on businesses, the political and lobbying environment in the United States makes that challenging. Many substances are also seen as indispensable to businesses and consumers, even if they do have health and environmental risks (Salzman and Thompson 2019, 209). This also supports the idea that costs should be encumbered on businesses that profit from the substances. It also supports the concept of risk and uncertainty labeling to help shift consumer behavior to less risky materials wherever possible. This would help reduce the use of harmful substances and increase investments in green chemistry approaches. Costs and risks from toxic substances are often shouldered by society as businesses externalize those issues. Since businesses are profiting from these substances, they should be the ones required to fund the research and information needed to regulate new and existing substances. Regulators should try to develop efficient frameworks of information requirements to help reduce the overall costs to business compliance.

Author: Logan Callen


Salzman, James, and Barton H. Jr. Thompson. 2019. Environmental Law and Policy. 5th ed. St. Paul, MN: Foundation Press.

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