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US EPA Finalizes Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act

On July 20, 2017, as required under the amended section 6(b)(4) of the Toxic Substances Control Act (TSCA) EPA has finalized its 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, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step in the new chemical review process after prioritization of chemicals for review. When a chemical is determined to be a high priority for review, EPA must then conduct a risk evaluation prior to proposing any regulations governing that chemical use.  On July 20, 2017, as required under the amended section 6(b)(4) of the Toxic Substances Control Act (TSCA) EPA has finalized its 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, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step in the new chemical review process after prioritization of chemicals for review. When a chemical is determined to be a high priority for review, EPA must then conduct a risk evaluation prior to proposing any regulations governing that chemical use. The procedures are governed by the requirements of the amended TSCA. The amended TSCA requires EPA to publish a scope of risk evaluation for each reviewed chemical. The scope of the evaluation in these rules includes the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider. TSCA also requires that the scope of the risk evaluation must be published no later than six months after the initiation of the risk evaluation of the chemical. It must also, in accordance with TSCA, do the following: integrate and assess available information on hazards and exposure for the conditions of use of the chemical substance, including information on specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations, describe whether aggregate or sentinel exposures were considered and the basis for that consideration, take into account, where relevant, the likely, duration intensity, frequency, and number of exposures under the conditions of use, and describe the weight of scientific evidence for the identified hazards and exposure. When weighing the scientific evidence in conducting the risk evaluation, EPA will employ the scientifically accepted and commonly used weight-of-evidence (WoE) approach. The new rules also require that EPA allow at least 30 days of public comment before finalizing each risk evaluation. The new risk evaluation process will be used for the following: the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances which EPA has initiated a risk evaluation in response to manufacturer requests. Importantly, the final rule can be found in 40 CFR 702 and becomes effective on September 18, 2017. Source: US EPA Finalizes Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act, 82 FR 33726 (2017). 

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