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EPA reverses course, determines TSCA chemical presents ‘unreasonable risk’

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Washington — In a reversal of preliminary findings that the chemical substance Pigment Violet 29 poses no unreasonable risk of injury to humans or the environment, the Environmental Protection Agency is seeking public comment on a revised draft risk evaluation that states the chemical substance presents unreasonable risk to workers under certain conditions, according to a notice published in the Oct. 30 Federal Register.

Primarily used as a colorant in consumer products such as paints, coatings, plastics and rubber products, Pigment Violet 29 is one of the first 10 chemicals evaluated for potential health and environmental risks under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

According to the revised draft risk evaluation, several occupational use scenarios pose unreasonable risk, including:

  • Domestic manufacture and import
  • Paint and coating processing
  • Plastic and rubber product processing
  • Recycling
  • Industrial and commercial use of plastic and rubber products in automobile plastics

Published in November 2018, the initial draft risk evaluation was the first released under the Toxic Substances Control Act, which the Lautenberg Act amended. Subsequent analysis by the Science Advisory Committee on Chemicals, required under TSCA, presented concerns over “large data gaps that preclude coming to confident conclusions regarding certain subpopulations.” Additionally, SACC concluded that “the greatest exposures to PV29 will likely occur in manufacturing and occupational workers via inhalation and dermal exposures.”

In response, EPA in February ordered a manufacturer and an importer of the chemical substance to provide additional information that required testing on the solubility of Pigment Violet 29 as well as worker respirable dust monitoring.


Comments on the revision are due Nov. 30.

EPA solicited comments on problem formation documents for the first 10 chemicals before transitioning to the draft risk evaluation phase. The agency previously indicated that it planned to release final risk evaluations for the first 10 chemicals by the end of this year.

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