Last week the US EPA released three draft rules under the recently updated Toxic Substances Control Act (TSCA). The proposed regulations will transform EPA’s approach to chemical safety evaluation. The inventory reset rule will require chemical importers and manufacturers to report 10 years of data to EPA, which EPA will use to designate active chemicals on the TSCA inventory. EPA will then categorize all active chemicals as either high priority or low priority for further risk evaluation, following procedures proposed in the chemical prioritization rule. Chemicals designated as high priority will undergo an extensive, multi-year risk evaluation.
Inventory Reset Rule
Under the proposed inventory reset rule, US chemical manufacturers and importers must report to EPA all chemicals manufactured and imported for nonexempt commercial purposes during the 10-year period ending June 21, 2016. Chemical processors may also choose to report. An interim list of “active” chemicals based on 2012 Chemical Data Reporting (CDR) would be exempt from further reporting, as would certain other chemicals, such as naturally occurring substances. CBI claims for chemicals on the confidential inventory must be thoroughly substantiated, and will be reviewed by EPA. However, the rule would allow joint submissions with chemical suppliers, protecting the identity of confidential ingredients from importers and processors.
Chemical Prioritization Rule
Chemicals placed on the active inventory must be assessed under the proposed chemical prioritization rule. The proposed four-step process would screen chemicals based on risk, focusing first on chemicals known to be particularly hazardous (i.e., carcinogenic and highly toxic). EPA must specifically consider the best available science and take a weight-of-evidence approach. However, the proposed rule does not provide TSCA-specific definitions for these terms. The prioritization process will include two 90-day public comment periods, including a call for relevant hazard and exposure information, which begins when EPA identifies a substance as a candidate for designation analysis.
Risk Evaluation Rule
Three groups of chemicals will undergo risk evaluation under the proposed risk evaluation rule: 1) chemicals designated as high priority substances, 2) chemical substances requested by manufacturers, 3) the first 10 chemicals from the 2014 TSCA workplan already designated by the agency. The risk evaluation will be an extensive, three-year process that considers the full life cycle of the chemical substance (from manufacturing to disposal). It will include public comment periods on both the scope and the draft evaluation. Particular consideration will be given to potentially exposed and susceptible subpopulations (e.g., workers, children). EPA must specifically consider the best available science and apply a weight-of-evidence approach. Interested parties may submit draft risk evaluations to EPA to consider. Chemicals assessed as having “unreasonable risk” must be controlled with risk management measures, but the definition of “unreasonable risk” in this new context is still uncertain.
Comments on the inventory reset rule are due March 14, 2017, and comments on prioritization are due March 20, 2017. Please contact Gradient if you would like help understanding how these rules will impact your business. Please feel free to contact one of the Gradient experts listed at right or visit our website to learn more about our Chemical Registration and Risk Sciences services.
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