EPA Regulatory Alert: TSCA Risk Evaluation Process

20 Nov
TSCA Risk Evaluation


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The Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) (modified in 2016 by the Frank R. Lautenberg Chemical Safety Act) requires EPA to conduct a risk evaluation to determine whether a chemical substance presents an unreasonable risk to health or the environment under the conditions of use.

On October 19, 2023, EPA proposed a new rule to strengthen its process for conducting these risk evaluations under TSCA. The rule is intended to:

  • Ensure EPA’s processes better align with the provisions of the law.
  • Support more robust evaluations that account for all risks.
  • Provide a foundation for protecting workers and communities from toxic chemicals with more protective rules for workers and communities.

TSCA Background

The TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the U.S. The current inventory contains 86,718 chemicals, of which 42,242 are active in U.S. commerce. EPA evaluates existing and new chemicals for the inventory:

  • Existing chemicals: EPA prioritizes existing chemicals on the list and selects chemicals to determine if the risk is reasonable or unreasonable. If the risk is unreasonable, EPA will impose restrictions to eliminate the risk. The list of ongoing and completed evaluations is available online.
  • New chemicals: Any chemical that is not currently on the inventory is considered a “new chemical substance.” Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose must provide EPA with a Premanufacture Notice (PMN) at least 90 days before initiating the activity. During the notice review period, EPA will review the PMN and determine if the chemical presents unreasonable risk(s) to human health or the environment.

Proposed Provisions

The new proposed rule aims to strengthen EPA’s process for conducting its TSCA chemical risk evaluations. EPA initially finalized a risk evaluation framework rule in 2017; however, it was quickly challenged in Court. The October 2023 proposed rule addresses the Court’s revisions and adds provisions requiring that risk evaluations:

  • Consider the disproportionate harms facing overburdened communities, including multiple exposure pathways to the same chemical and combined risks from multiple chemicals.
  • Be comprehensive and not exclude conditions of use or exposure pathways.
  • Consider risks to workers.
  • Use best available science.
  • Provide a single determination of whether the chemical presents unreasonable risk, rather than multiple determinations based on individual chemical uses.
  • Ensure transparency through updated risk evaluation documents.
  • Better align manufacturer-requested risk evaluations with EPA-initiated risk evaluations.

While many of these changes were announced in 2021 and have been incorporated into TSCA risk evaluations over the past two years, they have not been finalized in the Code of Federal Regulations. Doing so will help ensure more certainty regarding the process for conducting TSCA risk evaluations moving forward.

How This Impacts You/What You Need to Do

This rulemaking aligns with Goal 7 of the FY 2022-2026 EPA Strategic Plan to ensure the safety of chemicals for people and the environment. That Plan focuses on strengthening EPA’s ability to successfully implement TSCA with appropriate resources to complete EPA-initiated chemical risk evaluations and risk management actions.  

  • If you manufacture or import chemicals, determine if the chemical is on the TSCA inventory.
  • If you manufacture or import a chemical that is not on the inventory, complete a PMN at least 90 days before initiating the activity.

EPA will conduct a risk evaluation to determine the risk(s) the chemical poses to human health or the environment. Under the proposed rule, these evaluations will be more robust to account for all risks to better protect workers and communities from toxic chemicals.

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