As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), the EPA is issuing a rule that establishes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment. This is without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use.
This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This rule identifies the steps of a risk evaluation process including: scope, hazard assessment, exposure assessment, risk characterization, and finally a 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 prioritization process and those chemical substances for which EPA has initiated a risk evaluation in response to a manufacturer request, will always be subject to this process. The final rule also includes the required “form and criteria” applicable to such manufacturer requests.
As required under section 6(b)(1) of the Toxic Substances Control Act (TSCA), EPA is also issuing a final rule that establishes the process and criteria that 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. The final rule describes the processes for formally initiating the prioritization process on a selected candidate, providing opportunities for public comment, screening the candidate against certain criteria, and proposing and finalizing designations of priority. Prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under TSCA.
The EPA has als released a guidance document. entitled “Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act”. The document is intended to assist interested persons, or external parties, in developing and submitting draft risk evaluations to be considered by EPA under TSCA. The guidance document addresses the science standards, the data quality considerations, and the steps of the risk evaluation process that external parties should follow when developing draft risk evaluations for consideration by EPA