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 always or properly wear personal protective equipment (PPE).

On this page:

• Risk evaluation findings
• Using products safely
• 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 factors as part of its unreasonable risk determination. 

EPA determined that PV29 presents unreasonable risk to human health. The agency assessed the impact of PV29 on workers, the general population, and consumers. EPA found unreasonable risk to workers and occupational non-users from manufacture, 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 drive the whole chemical determination of unreasonable risk to human health. 

Risk to the environment does not drive 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 drive the PV29 whole chemical unreasonable risk determination due to risks identified for human health. These conditions of use continue to drive 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; and

• Disposal.

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.

Using Products Safely

For any chemical product, EPA strongly recommends that users carefully follow all instructions on the product’s label. 

Workers using PV29 products should continue to follow label instructions and applicable workplace regulations and should properly use appropriate personal protective equipment.

Next Steps and Public Participation

EPA will propose and take public comments on a risk management action to address the unreasonable risk identified in the risk evaluation, as updated with the final revised risk determination. EPA’s proposed regulation could include requirements on how the chemical is commercially used, or limiting or prohibiting the manufacture, processing, distribution in commerce, commercial use, or disposal of this chemical substance, as applicable. 

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. EPA 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.

Stay up to date on additional opportunities for public participation. Just like the risk evaluation process, there will be opportunities for public comment as EPA works to propose and finalize any risk management action for PV29. You can stay informed by signing up for our email alerts or checking the public docket at EPA-HQ-OPPT-2016-0725 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)