U.S. EPA Releases First Draft Risk Evaluation under Amended TSCA

Posted on: November 21, 2018

TSCA Draft Risk EvaluationBy John J. Kowalski, CHMM

The 2016 amendments to the Toxic Substances Control Act (TSCA) established a new process for the prioritization, risk evaluation, and risk management of existing chemicals.

As part of that process, the U.S. Environmental Protection Agency (the EPA or “the Agency”) did the following:

  • Published an initial list of 10 TSCA Work Plan chemicals to undergo risk evaluations on December 19, 2016
  • Announced the availability of scope documents for those chemicals on July 7, 2017
  • Announced the release of the 2018 Annual Plan for Chemical Risk Evaluations on January 31, 2018
  • Released problem formulation documents, which refined the scope of the initial 10 risk evaluations, on June 1, 2018.

The 2018 Annual Plan for Chemical Risk Evaluations discusses the initial list of 10 chemicals.

The First Draft Risk Evaluation

On November 15, 2018, the EPA published a notice announcing the availability of a draft risk evaluation for one of those chemicals, C.I. Pigment Violet 29 (CAS Registry Number 81-33-4), along with associated documents.

While this draft risk evaluation is obviously important to any company that manufactures, imports, processes, or uses C.I. Pigment Violet 29 or products containing that substance, as it is the first draft risk evaluation which has been released under the 2016 amendments, it also sheds light on the Agency’s approach to the risk evaluation of existing chemicals.

The draft risk evaluation concludes that “C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or the environment, without considering costs or other non-risk factors, including no unreasonable risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use.”

Public Comments on the Draft Risk Evaluation

Comments on this draft risk evaluation must be received on or before January 14, 2019. All comments submitted will be provided to the TSCA Science Advisory Committee on Chemicals (SACC), which will peer review the draft risk evaluation.

According to the EPA, draft risk evaluations for the remaining nine chemicals will be released for public comment over the coming months. Furthermore, the Agency plans to issue final risk evaluations for the first ten chemicals by December 2019.

Next Steps

  • Review the draft risk evaluation
  • Consider submitting comments
  • Continue to watch this space for information regarding new developments under TSCA.

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Useful Information

Draft TSCA Risk Evaluation for Colour Index (C.I.) Pigment Violet 29 (PV29) [PDF]


United States, EPA, TSCA, Toxic Substances Control Act, Draft Risk Evaluation, Colour Index, C.I. Pigment Violet 29, Environmental Protection Agency, TSCA Science Advisory Committee on Chemicals, SACC


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