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| EPA/OCSPP | RIN: 2070-AK87 | Publication ID: Spring 2025 |
| Title: C.I. Pigment Violet 29; Regulation Under the Toxic Substances Control Act (TSCA) | |
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Abstract:
On January 14, 2025, the Environmental Protection Agency (EPA or Agency) proposed to address the unreasonable risk of injury to human health presented by C.I. Pigment Violet 29 (CASRN 81-33-4, also known as PV29), under its conditions of use as documented in EPA's January 2021 Risk Evaluation for PV29 and the September 2022 Revised Risk Determination for PV29 prepared under the Toxic Substances Control Act (TSCA). PV29 is a perylene pigment that is reddish-purple in color and is currently manufactured as a powder, slurry, or paste. It is used to dye products, such as plastics and paints, and is commonly used in automobile paints and coatings. It has been recognized for its high color strength, weather fastness and heat stability. The reasons for these high-performance characteristics have been attributed to the organizational structure of the molecule. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. EPA determined that dry powder PV29, but not PV29 already incorporated into a liquid mixture such as wet paint or ink, presents an unreasonable risk of injury to health due to the significant adverse health effects associated with inhalation exposure. PV29 may increase lung burden which may result in kinetic lung overload, a pharmacokinetic phenomenon, which is not due to the overt toxicity of the chemical, but rather the possibility that C.I. Pigment Violet 29 dust overwhelms the lung clearance mechanisms over time. The inhalation toxicity data on the analogue carbon black demonstrated increased lung burden, alveolar hyperplasia, and inflammatory and morphological changes in the lower respiratory tract. To address the identified unreasonable risk, EPA proposed to require the use of assigned protection factor (APF) 50 respirators and equipment and area cleaning to address the risk from inhalation exposure to dry powder PV29 (also referred to as regulated PV29), for certain conditions of use where dry powder PV29 is expected to be present to protect workers from the unreasonable risk of PV29 during manufacturing and processing, certain industrial and commercial uses of the chemical, and disposal. EPA also proposed to establish recordkeeping and downstream notification requirements. EPA's final risk evaluation for PV29, describing PV29's conditions of use and presenting EPA's determination of unreasonable risk, is in docket EPA-HQ-OPPT-2018-0604, with revised risk determination and additional information in docket EPA-HQ-OPPT-2016-0725. |
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| Agency: Environmental Protection Agency(EPA) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
| Major: No | Unfunded Mandates: No |
| EO 14192 Designation: Not subject to, not significant | |
| CFR Citation: 40 CFR 751 | |
| Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act | |
Legal Deadline:
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
| Small Entities Affected: Businesses | Federalism: Yes |
| Included in the Regulatory Plan: No | |
| International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
| RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-ci-pigment-violet-29 | |
| Sectors Affected: 325 Chemical Manufacturing | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Carolyn Mottley Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 1200 Pennsylvania Avenue , Mail Code 7404M, Washington, DC 20460 Phone:202 566-1955 Email: mottley.carolyn@epa.gov Robert Courtnage Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 7404T, Washington, DC 20460 Phone:202 566-1081 Email: courtnage.robert@epa.gov |
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