EPA’s New Chemicals Review Program Under TSCA: A Look at the Numbers

Under the Toxic Substances Control Act (TSCA), amended and updated in 2016 via the Frank R. Lautenberg Chemical Safety for the 21st Century 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. The Agency has established a well-defined review process for new chemical substances. In this blog post we take a look at some of the statistics for active and completed cases in the program.

About the New Chemicals Review Process

There are six principal stages included in the EPA's review process for new chemicals.

  • Pre-Submission
    • When submitting a new chemical substance, companies should set up a pre-notice consultation with the EPA to discuss their submission and to ensure they have a proper understanding of the review process. The Agency offers informative tools to aid in submission preparation and estimation of environmental release, environmental fate, exposures, and more.
  • Incoming Cases
    • Prior to the start of risk assessment, a pre-screen submission review is conducted to verify inclusiveness of necessary information and to check for errors. 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 unreasonable human or environmental health risks, the EPA conducts a complete life-cycle risk assessment. During this assessment, a variety of factors (chemistry, environmental fate, etc.) 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 additional information for support or clarification, which the Agency may then use to modify the original risk assessment, as needed.
  • 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.

Reviewing the Numbers

In the approximately 3 years since the Lautenberg Act was signed into law on June 22, 2016, numerous chemicals have undergone review. Here we present some key statistics, through July 23, 2019, for chemicals in the review process.

  • 443 active new chemical cases for Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), and Microbial Commercial Activity Notices (MCANs) are under review.
    • 26 in the Risk Assessment stage
    • 174 in the Risk Characterization stage (plus an additional 157 cases awaiting submitter information or action)
    • 65 in the Regulatory Decision and Action Development stage (plus an additional 21 cases awaiting submitter signature on order)
  • 1,073 PMN/SNUN/MCAN reviews have been completed.
    • 338 designated “allowed to commercialize without restrictions”
    • 472 designated “allowed to commercialize with restrictions pending information development, if applicable”
    • 8 designated “not allowed to commercialize pending development of information”
    • 255 with cases withdrawn
  • 1,144 Low Volume Exemption (LVE)/Low Release and Low Exposure (LoREX) Exemption reviews have been completed.
    • 950 with exemptions granted
    • 128 with exemptions denied
    • 66 with exemptions cases withdrawn

In total, 2,867 cases were reviewed during this time period.

PMN/SNUN/MCAN Cases Under Review443
Invalid or Incomplete Cases207
Completed Reviews2,217
Total Reviews2,867

Source: U.S. Environmental Protection Agency

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