Risk Evaluation for C.I. Pigment Violet 29
EPA evaluated C.I. Pigment Violet 29 (PV29) under the amended Toxic Substances Control Act (TSCA) and issued a final revised risk determination in September 2022 that amends the risk evaluation issued in January 2021. The revised risk determination follows public notice and receipt of comments on a draft revised risk determination for PV29. The revisions to the risk determination were made in accordance with the path forward for the first 10 risk evaluations under TSCA laid out by EPA in June 2021. The final revised risk determination is based on PV29 as a whole chemical substance and does not assume that all workers exposed to PV29 are protected by personal protective equipment.
As a next step in the process and consistent with the statutory requirements of TSCA section 6(a), EPA will propose risk management regulatory action to the extent necessary so that PV29 no longer presents an unreasonable risk.
EPA expects to focus its risk management action on the conditions of use that drive the unreasonable risk. However, it should be noted that, under TSCA section 6(a), EPA is not limited to regulating the specific activities found to drive unreasonable risk and may select from among a suite of risk management requirements in section 6(a) related to manufacture (including import), processing, distribution in commerce, commercial use, and disposal as part of its regulatory options to address the unreasonable risk.
As a general example, EPA may regulate upstream activities (e.g., processing, distribution in commerce) to address downstream activities (e.g., consumer uses) driving unreasonable risk, even if the upstream activities do not drive the unreasonable risk. The public will have an opportunity to comment on the proposed risk management rule.
On this page:
Background on PV29 and Its Uses
PV29 is currently manufactured, processed, distributed, used, and disposed of as part of industrial, commercial, and consumer conditions of use. Applications for this chemical include use as an intermediate to create or adjust color of other perylene pigments, incorporation into paints and coatings in the automobile industry, incorporation into plastic and rubber products in automobiles and industrial carpeting, use in merchant ink for commercial printing, and use in consumer watercolors and acrylic artist paint.
In the final revised risk determination, EPA found unreasonable risk to workers and occupational non-users from PV29 as a whole-chemical substance. The conditions of use that drive the whole chemical unreasonable risk determination are the same as the January 2021 risk evaluation: domestic manufacturing and import of the chemical; processing (incorporation into formulation, mixture or reaction products in paints, coatings, plastic and rubber products; use as an intermediate for other perlyene pigments; and recycling); industrial/commercial use in paint and coatings in the automobile sector, and merchant ink for commercial printing; and disposal. Risks to workers, including occupational non-users, can come from long-term inhalation exposure. These risks drive the whole chemical determination of unreasonable risk to human health.
The conditions of use that do not drive EPA’s unreasonable risk determination for PV29 include distribution in commerce; industrial and commercial uses in finished plastic and rubber products for automobile plastics and industrial carpeting; and consumer use in professional quality watercolor and acrylic artist paint.
- Read the September 2022 final revised unreasonable risk determination for PV29.
- Read the 2021 risk evaluation for PV29.
In October 2020, EPA released a revised draft risk evaluation for PV29 for public comment and peer review.
In February 2020, EPA issued test orders under section 4 of TSCA to obtain new information to help address the data uncertainties identified during the peer review of the November 2018 draft risk evaluation.
In November 2018, EPA released a draft risk evaluation for PV29 for public comment and peer review.
- The November 2018 draft risk evaluation and supporting documents are available in docket EPA-HQ-OPPT-2018-0604 on www.regulations.gov.
In June 2017, EPA released the scope document for PV29 which included the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations EPA expected to consider in its risk evaluation. In June 2018, EPA released the problem formulation for PV29 which refined the scope of the risk evaluation by clarifying the chemical conditions of use that EPA expected to evaluate and describing how EPA expected to conduct the evaluation.
After releasing the scope documents, the dockets for each of the first 10 chemicals were open for public comments. Read EPA’s Responses to Public Comments Received on the Scope Documents for the First Ten Chemicals for Risk Evaluation under TSCA. This document addresses cross-cutting public comments received in response to EPA publishing the scope documents.