Date: Jun 28, 2017
On June 22, 2017, the U.S. Environmental Protection Agency (EPA) released a prioritization rule, inventory update rule, risk evaluation rule, external risk evaluation guidance, and notice on scoping documents for the first ten chemical substances, all designed to implement statutory changes under the amended Toxic Substances Control Act (TSCA). These rules have yet to be published in the Federal Register, but as soon as they are published we will post the links.
Below we provide short summaries of the rules.
The EPA’s prioritization rule establishes the process and criteria for identifying “high priority” chemicals for risk evaluation and “low priority” chemicals for which such an evaluation is not necessary. By December 22, 2019, EPA must have designated at least 20 chemical substances as either low or high-priority substances. Some of the key takeaways from the prioritization rule include:
Risk Evaluation Rule
The risk evaluation rule establishes the guidelines to determine whether a chemical presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to potentially exposed or susceptible populations. EPA must evaluate hazard and exposure while excluding cost considerations, and ensure that decisions are based on the weight-of-scientific-evidence. Some key findings from the risk evaluation rule include:
Guidance to External Parties for Submitting Draft Risk Evaluations
This guidance document describes the science, standards, and processes that should be followed when an interested party is drafting and submitting a risk evaluation for EPA. EPA’s general expectation is that interested party draft risk evaluations will be of the same quality as those developed by EPA.
Scoping Documents for the First Ten Chemical Substances
On December 19, 2016, EPA published a list of 10 substances that are the subject of the Agency’s initial chemical risk evaluations, as required by TSCA § 6(b)(2)(A). The scoping documents that correspond to these first 10 chemicals outline the risk evaluations, hazards, exposures, conditions of use, and potentially susceptible populations that the Agency expects to consider under TSCA. EPA will be accepting public comments on a problem formulation document that will refine the current scope, which document is expected to be released within approximately six months of publication of the scoping documents. The scoping documents for each of the chemical substances can be found below:
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