President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US.
Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to assess the toxicity of chemicals.
And like FDA’s user fee agreements, the TSCA reform allows EPA to collect up to $25 million in fees each year to help defray the costs of chemical regulation, in addition to congressional appropriations.
These user fees can be used to help better implement the law, including prioritizing existing chemicals and conducting and completing safety assessments and determinations.
Within two years of enactment, the EPA must develop any policies, procedures and guidance necessary to request safety data from manufacturers or processors, prioritize existing chemicals to evaluate their risks, review new chemicals or significant new uses of existing chemicals, and conduct safety assessments and safety determinations on whether a chemical meets the safety standard.
These science-based assessments of “high-priority” chemicals are required to be transparent and consider the risks for potentially exposed or susceptive subpopulations identified by EPA.
The law also mandates that the EPA update the chemicals it tracks and create a risk evaluation process.
The Physicians Committee for Responsible Medicine, a nonprofit with 12,000 doctor members, praised the law’s signing and said it requires alternatives to animal tests to be considered and used, and places restrictions on animal testing—which are stronger than current law—that will over time facilitate the development and adoption of human-relevant, non-animal testing methods.
“Because information obtained on chemicals will be human-relevant, products Americans use will be safer,” the nonprofit said.
H.R.2576 - Frank R. Lautenberg Chemical Safety for the 21st Century Act