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Assessing and Managing Chemicals under TSCA

Final Risk Evaluation for C.I. Pigment Violet 29

As part of EPA’s mission to protect human health and the environment, the agency has completed a final risk evaluation for C.I. Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA). In the final risk evaluation, EPA reviewed 14 conditions of use, including as an intermediate for other perylene pigments, as  well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used primarily in the automobile industry, in ink used for commercial printing, and in consumer watercolors and artistic paints.

The PV29 risk evaluation contains the agency’s final determinations on which conditions of use present unreasonable risks to human health or the environment based on a robust review of the scientific data. To prepare the final risk evaluation, EPA reviewed extensive scientific literature, conducted modeling and other risk assessment activities, and collected toxicity, exposure, and hazard information from many sources.

Releasing a final risk evaluation is the last step in the scientific evaluation process required by TSCA and will guide the agency’s efforts to issue regulations to address unreasonable risks associated with this chemical. EPA has one year to propose and take public comments on any risk management actions.

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Risk Evaluation Findings

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

EPA found no unreasonable risk to the environment for any conditions of use. EPA has determined that this chemical does not present an unreasonable risk to the environment (aquatic, sediment-dwelling and terrestrial organisms) from all conditions of use, based on the risk estimates, the environmental effects, the exposures, physical-chemical properties, and consideration of uncertainties.

EPA found no unreasonable risk to consumers, bystanders, or the general population. EPA has determined that there is no unreasonable risk to consumers who use watercolor and acrylic paints containing PV29. Given limited exposure to PV29, EPA has also determined that this chemical does not present an unreasonable risk to the general population from all conditions of use, based on the risk estimates, the exposures, physical-chemical properties, and consideration of uncertainties.

EPA found unreasonable risk to workers and occupational non-users from 10 out of 14 conditions of use. EPA found unreasonable risks to workers and workers nearby but not in direct contact with this chemical (known as occupational non-users) from seven manufacturing, processing and disposal uses of PV29. Additionally, EPA found unreasonable risks from three industrial and commercial uses of this chemical to workers and occupational non-users. This includes an unreasonable risk to workers and occupational non-users when used in domestic manufacturing or import of the chemical; incorporation into formulation, mixture or reaction products in paints, coatings, plastic and rubber products; use as an intermediate for other perlyene pigments; use in paintings and coatings in the automobile sector, and merchant ink for commercial printing; recycling; and disposal. Risks to workers and occupational non-users can come from long-term inhalation exposure.

Using Products Safely

While EPA is working through the process required by TSCA to address the unreasonable risks found from PV29, the information below provides ways to reduce exposure.

For any chemical product, EPA strongly recommends that users carefully follow all instructions on the product’s label and on the safety data sheets. Workers using PV29 products should continue to follow the label/safety data sheets and applicable workplace regulations and should properly use appropriate personal protective equipment, as needed. Additionally, safety data sheets developed by the manufacturer provide instructions on the proper use of this chemical including using the product in well-ventilated areas.

Next Steps and Public Participation

The next step in the process required by TSCA is risk management. EPA will propose and take public comments on actions to address the unreasonable risks identified in the risk evaluation. According to TSCA, the agency must finalize those actions within two years of completing the final risk evaluation. EPA’s proposed regulations could include requirements on how the chemical is used, or limiting or prohibiting the manufacture, processing, distribution in commerce, use, or disposal of this chemical substance, as applicable.

EPA is committed to being open and transparent as the agency follows the process required by the law for evaluating unreasonable risks from chemicals. EPA will continue to keep the public updated as the agency moves through the risk management process. Following the comprehensive risk evaluation process required by TSCA ensures that the public has confidence in EPA’s final conclusions about whether a chemical substance poses any unreasonable risks to health or the environment under the conditions of use. This then allows the public to have confidence in the risk management actions taken to ensure the safety of chemicals on the market.

There will be 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 risk management actions for PV29. You can stay informed by signing up for our email alerts or checking the public docket at EPA-HQ-OPPT-2018-0604 on www.regulations.gov

Final Risk Evaluation and Supporting Documents

The final risk evaluation for PV29, non-technical summary, response to comments, and other supporting documents are below.

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