An Overview of EPA’s Review Process for New Chemicals Under the Toxic Substances Control Act

In 2016, the Toxic Substances Control Act (TSCA) was amended and updated via the Frank R. Lautenberg Chemical Safety for the 21st Century Act. With this law (Lautenberg Act), the U.S. Environmental Protection Agency (EPA) must determine if a new chemical poses an unreasonable risk to human health or the environment under normal use conditions. Here we present a general overview of the EPA’s review process for new chemical substances.

New Chemical Review Process Steps

There are six principal stages involved in the EPA's review process for new chemicals. These apply to the roughly 470 active cases currently under review by the Agency.

  • Pre-Submission
    • When submitting a new chemical substance, companies should set up a pre-notice consultation with the EPA to discuss their submission. Such meetings are often focused on the preparation of notifications and ensuring their completeness for review. The EPA also offers additional informative tools to aid in submission preparation and estimation of environmental release, environmental fate, exposures to workers and the public, and more.
  • Incoming Cases
    • Occurring prior to the start of risk assessment, a pre-screen is a critical early step in a new chemical’s review process. This includes a submission review to verify inclusiveness of information and to check for errors. Required information typically includes data related to the chemical’s manufacture, processing, distribution, use, disposal, and other factors. Information that is incorrect, incomplete, or not in conformity with required regulations could result in suspension of the review by the EPA.
  • Risk Assessment
    • To determine if a chemical yields human or environmental health risks, the EPA conducts a complete life-cycle risk assessment. During this assessment, factors such as chemistry, environmental fate, and human and ecological hazard assessments are evaluated.
  • Risk Characterization
    • After an initial risk assessment has been proposed, the EPA informs submitters of its findings. Submitters have the option of providing the Agency with additional information for support or clarification, which it may then use to modify the original risk assessment.
  • Regulatory Decision and Action Development
    • A decision is made and documented by the EPA regarding the new chemical’s likelihood of causing unreasonable risk to health or the environment.
  • Final Determination
    • After the EPA’s final determination has been made, the Agency posts the decision on the new chemical substance in the status tables for TSCA Section 5 notices.

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