The U.S. chemical regulations regime, TSCA, was updated in 2016. Now, with nearly a year of hindsight, some in the chemicals industry are concerned that the new regulations are discouraging innovation.
This is not a new controversy. Many manufacturers and lawmakers worry that increased regulation can inhibit innovation. There hasn’t been much proof of this view. For new chemicals in the U.S., however, there may now be some evidence. Since the EPA has been required to make “affirmative safety decisions” for new substances, the EPA reports that 25% of requests to approve new substances have been withdrawn.
Before the the Frank R. Lautenberg Chemical Safety for the 21st Century Act became law, the EPA saw withdrawals for just about about 5% of new substances.
Reasons for withdrawals
One of the main reasons for companies to withdraw a request for EPA approval of a new substance is a need for testing. TSCA doesn’t require companies to test and demonstrate safety of their substances, as the EU’s REACH chemical regulations do.
The EPA makes its own determination of the safety of substances, often based on testing of similar substances. If the EPA doesn’t have enough information, they will request that the company provider further information, usually by testing the substance in question.
The company can go ahead with testing, or they can choose to withdraw their request for approval.
Affirmative safety decisions
Affirming that a new substance is safe is a much higher standard than the old requirement to identify substances that pose an “unreasonable” safety risk. Companies may be responding to potential costs of testing. Fees have not yet been set by the EPA, and that uncertainty may add to the incentive for companies to withdraw a new substance instead of conducting testing.
Since the new law is still being discussed and may see changes under the new administration,companies may also be going with a “wait and see” approach. If testing might not be required in future, delaying entry into the marketplace could be a cost-effective move for some companies… or at least a reasonable gamble.
Coping with new regulations
EUPHOR makes chemical regulation compliance smoother and more cost-effective. EUPHOR provides a framework for project management for chemical regulation compliance projects of all kinds. No matter how things shake out with TSCA, EUPHOR will give you the tools to succeed in compliance.
Companies using EUPHOR find that the increased efficiency and smoother collaboration helps to manage the costs of compliance. In a time of uncertainty, it makes sense to choose solutions with flexibility. Schedule a demo today and see what we mean.