New chemicals under amended TSCA: Same process, different outcome
The main drivers for amending the US's Toxic Substances Control Act (TSCA) were the perceptions that not enough was known about the risk to human health and the environment from the majority of existing chemicals in commerce, and that, even when risks were well known - such as with asbestos - it was difficult for the US Environmental Protection Agency (EPA) to take substantive action.
Chemicals introduced into commerce after the original TSCA inventory was compiled in 1979, known as 'new' chemicals, were subject to a risk evaluation or Pre-Manufacture Notice (PMN). New concepts used in the PMN risk assessment under amended TSCA pose a challenge to submitters: while the PMN process has remained the same, the outcomes have changed. To avoid extensive delays and the potential for an undesirable outcome, it is essential first to determine whether sufficient information is included with the notice for the agency to make a quantitative determination of risk from exposures and releases during the lifecycle of the substance; and secondly, to consider all reasonably foreseen uses.
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