Final Risk Evaluation for C.I. Pigment Violet 29

In September 2022, EPA released a final revised risk determination for C.I. Pigment Violet 29 (PV29) as a whole-chemical substance. This revision supersedes the previous condition of use-specific no unreasonable risk determinations in the 2021 PV29 risk evaluation (and withdraws the associated order). 

These chemical-specific changes are 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 does not assume that workers exposed to PV29 are always provided or properly wear personal protective equipment (PPE). The consideration of this information is part of the risk management process.

Read the Federal Register notice.

Read the final revised PV29 risk determination.

Read the Response to Public Comments to the draft revised Unreasonable Risk Determination for PV29.

On this page:

• Risk evaluation findings
• Next steps and public participation
• Final risk evaluation and supporting documents

On other pages:

• Read about the steps in EPA’s risk evaluation process for PV29.
• Learn more about EPA’s risk evaluation process.

Risk Evaluation Findings

In September 2022, EPA released a final revised risk determination for PV29. The final revised risk determination finds that PV29 presents an unreasonable risk of injury to health when evaluated under its conditions of use. 

In the January 2021 risk evaluation, EPA reviewed the exposures and hazards of PV29 uses and made risk findings on this chemical. This risk evaluation includes input from the public and peer reviewers as required by TSCA and associated regulations. EPA considered the hazards and exposure, magnitude of risk, exposed population, severity of the hazard, uncertainties, and other risk-related factors as part of its unreasonable risk determination. 

EPA determined that PV29, as a whole chemical substance, presents unreasonable risk to human health. 

EPA assessed the impact of PV29 on workers, the general population, and consumers. EPA found unreasonable risk to workers, including occupational non-users (workers nearby but not in direct contact with this chemical), from manufacture (including import), processing, industrial/commercial use in paints and coatings and merchant ink, and disposal. This is based on the severity of the health effects (specifically lung toxicity effects known as alveolar hyperplasia or an adverse increase in the number of cells in the lungs where oxygen transfer occurs) from long-term inhalation exposure. These risks contribute to the whole chemical determination of unreasonable risk to human health. 

Risk to the environment does not contribute to the unreasonable risk determination for PV29. EPA did not identify risk of injury to the environment (aquatic, sediment-dwelling and terrestrial organisms) based on the risk estimates, the environmental effects, the exposures, physical-chemical properties, and consideration of uncertainties.

Overall, 10 conditions of use of the 14 evaluated contribute to the PV29 whole chemical unreasonable risk determination due to risks identified for human health. These conditions of use continue to contribute to the unreasonable risk determination for PV29. These conditions of use include: 

• Domestic manufacturing and import.

• Processing.

• Incorporation into formulation, mixture, or reaction products in paints and coatings, and in plastic and rubber products.

• Processing: use as an intermediate in the creation or adjustment of color of other perylene pigments.

• Recycling.

• Industrial and commercial uses in paints for automobiles (e.g., original equipment manufacturing and refinishing), in coatings and basecoats, and in merchant ink for commercial printing.

• Disposal.

The conditions of use that do not contribute to 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.

• Consumer use in professional quality watercolor and acrylic artist paint.

The revised risk determination for PV29 does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE), even though some facilities might be using PPE as one means to reduce worker exposure, or that there is widespread non-compliance with applicable federal standards. EPA understands there could be occupational safety protections in place at some workplace locations; however, not assuming use of PPE in its baseline exposure scenarios reflects EPA’s recognition that certain subpopulations of workers exist that may be highly exposed because they are not covered by OSHA standards or because their employers are out of compliance with OSHA standards. The consideration of information on use of PPE, engineering controls and other ways industry protects its workers, as potential ways to address unreasonable risk are part of the risk management rule development process.

Next Steps and Public Participation

In December 2024, EPA proposed a risk management rule to address the unreasonable risk posed by PV29 to human health. Learn more and submit a comment.

Stay up to date on additional opportunities for public participation.  You can stay informed on the regulation of PV29 under TSCA by signing up for email alerts or checking the public docket at EPA-HQ-OPPT-2016-0725 and EPA-HQ-OPPT-2021-0277 on www.regulations.gov.

Final Risk Evaluation and Supporting Documents

Below are the final revised risk determination, final risk evaluation for PV29, non-technical summary, response to comments, and other supporting documents. 

The discussion of the issues in the final revision to the risk determination supersedes any conflicting statements in the prior PV29 risk evaluation and the response to comments document. 

Read the federal register notice.

• Final Revised Unreasonable Risk Determination for C.I. Pigment Violet 29 (pdf) (178.47 KB)
• Response to Public Comments, C.I. Pigment Violet 29 Revised Unreasonable Risk Determination, (pdf) (409.71 KB)
• Risk Evaluation for C.I. Pigment Violet 29 (pdf) (2.69 MB)
• Non-Technical Summary for C.I. Pigment Violet 29 (pdf) (142.77 KB)
• Summary of External Peer Review and Public Comments and Disposition for C.I. Pigment Violet 29 (pdf) (1.23 MB)
• Final Risk Evaluation for C.I. Pigment Violet 29 Systematic Review Supplemental File: Data Quality Evaluation of Physical and Chemical Property Studies (pdf) (264.53 KB)
• Final Risk Evaluation for C.I. Pigment Violet 29 Systematic Review Supplemental File: Data Quality Evaluation of Environmental Fate and Transport Studies (pdf) (300.53 KB)
• Final Risk Evaluation for C.I. Pigment Violet 29 Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure Data (pdf) (1.11 MB)
• Final Risk Evaluation for C.I. Pigment Violet 29 Systematic Review Supplemental File: Data Quality Evaluation of Environmental Hazard Studies (pdf) (230.16 KB)
• Systematic Review Supplemental File: Data Quality Evaluation of Environmental Hazard Studies Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies (pdf) (958.32 KB)
• Final Risk Evaluation for C.I. Pigment Violet 29 Supplemental File: Information Received from Manufacturing Stakeholders (pdf) (12.61 MB)