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EPA Advances Efforts to Determine Risk of Chemical Substances

The Environmental Protection Agency has issued separate final rules that advance its efforts to determine the risk of chemical substances, a process that could ultimately result in new requirements or restrictions on some chemicals. The first rule establishes the process and criteria the EPA will use to identify chemical substances as either high-priority substances for risk evaluation or low-priority substances for which risk evaluations are not warranted at the time. Prioritisation is the first step in a new process of existing chemical substance review and management established under recent amendments to the Toxic Substances Control Act. This rule describes the processes for formally initiating the prioritisation process on a selected candidate, providing opportunities for public comment, screening the candidate against certain criteria, and proposing and finalising designations of priority.
The second rule establishes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment (without consideration of costs or other non-risk factors) under the conditions of use. The EPA is required to mitigate any risks determined to exist, which could include labelling requirements, use restrictions or outright bans.

This rule identifies the steps of a risk evaluation process, including scope, hazard assessment, exposure assessment, risk characterisation and risk determination. This process will be used for the first ten chemical substances undergoing evaluation from the 2014 update of the TSCA work plan for chemical assessments (to the maximum extent practicable). Chemical substances designated as high-priority substances during the prioritisation process, and those for which the EPA has initiated a risk evaluation in response to a manufacturer request, will always be subject to this process. The rule also establishes the process by which manufacturers would make such requests and the criteria by which the EPA will evaluate them.

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