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Tue January 24, 2017

EPA Seeks Input from Manufacturers, Importers and Processors on Substances "Active" or "Inactive" in U.S. Commerce

As required with the amendment of the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has proposed a rule to determine which substances on the TSCA Inventory are “active” or “inactive” in U.S. commerce. Knowing whether a chemical substance is on the Inventory is critical for companies prior to the substance’s manufacture, import or use and any related restrictions.

The proposal includes activity notification procedures, information requirements and exemptions, as well as procedures for handling confidentiality claims:

  • Retrospective reporting would be required within 180 days of a final rule for all chemical substances on the TSCA Inventory that were manufactured/imported for non-exempt commercial purposes during a 10-year “lookback period” (ending June 21, 2016). The chemical identity and date range of activity would be required, but the necessary documentation is unclear.
  • Within 360 days of a final rule, EPA would also accept (but not require) notifications of listed chemical substances that were processed during that 10-year period. Processors may choose to submit notifications to ensure chemical substances they use are considered “active”.
  • “Forward-looking” procedures would also be established to electronically notify EPA if, for chemical substances designated as inactive, manufacturing or processing for non-exempt commercial purposes was expected to resume. Valid notices would result in EPA changing the status to active.
  • EPA is proposing to require the use of the agency’s Central Data Exchange (CDX) reporting portal. Processors may have limited or no experience with this system.
  • It’s unclear whether polymers manufactured under the original 1984 polymer exemption (versus the 1995 amendment) would need to be reported.

PLASTICS is reviewing these and other elements of the proposal, and seeking member input for comments to EPA. Comments are due on or before March 14; EPA must issue a final rule on or before June 22. For more information, please contact Marie Gargas.

EPA Seeks Comment on Proposed Rules for Chemical Prioritization and Risk Evaluation under Amended TSCA

Two key Environmental Protection Agency (EPA) rulemakings have advanced under the amended Toxic Substances Control Act (TSCA) – Procedures for Prioritization of Chemicals for Risk Evaluation (published January 17) and Procedures for Chemical Risk Evaluation (released January 13). EPA must issue final rules or before June 22 on these two framework actions.

  • Prioritization: EPA is required to establish a process and criteria for the identification of High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at that time. This proposed rule seeks to establish a risk-based approach to that end. It also describes processes to: identify and select candidates for prioritization, screen candidates, initiate prioritization, obtain public comment, and propose and reach designations.
  • Risk Evaluation: EPA is required to evaluate the risk of High-Priority Substances. This proposal seeks to establish a process for such evaluations to determine if a chemical substance presents an unreasonable risk of injury to health or the environment, absent consideration of costs or other non-risk factors, under the conditions of use. The proposal addresses: scope, hazard assessment, exposure assessment, risk characterization, and risk determination, as well as manufacturer requests for risk evaluations. In addition, this process is being proposed for use in evaluating the first ten chemical substances identified last for November for evaluation.

PLASTICS is reviewing these proposed rules and seeking member input for comments to EPA. Comments are due 60 days following publication in the Federal Register. For more information, please contact Marie Gargas.