EPA Releases Draft Revised Risk Determination for PV29 for Public Comment
Released on March 7, 2022.
Today, the U.S. Environmental Protection Agency (EPA) released for public comment a draft revision to the risk determination for C.I. Pigment Violet 29 (PV29) pursuant to the Toxic Substances Control Act (TSCA) section 6(b). Common uses of PV29 include as an intermediate to create or adjust color of other perylene pigments, incorporation into paints and coatings primarily in the automobile industry, incorporation into plastic and rubber products primarily in automobiles and industrial carpeting, use in merchant ink for commercial printing, and use in consumer watercolors and artistic color. When final, the revised risk determination will better align with objectives of protecting human health and the environment under the amended TSCA.
In June 2021, EPA announced a path forward for the first 10 chemicals to undergo risk evaluation to ensure the public is protected from unreasonable risks from these chemicals in a way that is supported by science and the law. The draft revised risk determination for PV29 was developed in accordance with these policy changes, as well as the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review.
The draft revised risk determination finds that PV29, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. EPA is proposing to use the whole chemical risk determination approach for PV29 in part due the benchmark exceedances for multiple conditions of use for human health and the irreversible 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) associated with PV29 exposures.
EPA believes that a whole chemical approach better aligns with TSCA’s objective of protecting health and the environment for this chemical substance than the previous condition-of-use-specific determinations. However, the same ten conditions of use continue to drive the unreasonable risk determination. This revision proposes to supersede the condition-of-use-specific no unreasonable risk determinations in the 2021 PV29 risk evaluation (and withdraw the associated order).
The draft revised risk determination also does not reflect an assumption that workers always appropriately wear personal protective equipment (PPE). EPA plans to consider information on use of PPE, or other ways industry protects its workers, as potential way(s) to address unreasonable risk during the risk management process. Removing the assumptions of PPE use in making the whole chemical risk determination for PV29 would not alter the conditions of use or worker subpopulations that drive the unreasonable risk determination for PV29.
Note that EPA has not conducted new scientific analysis on this chemical and the risk evaluation continues to characterize risks associated with individual conditions of use in the risk evaluation of PV29.
These proposed revisions to the risk determination for PV29 help to ensure that EPA will be able to eliminate unreasonable risks caused by this chemical through the risk management process, resulting in better protections for human health and the environment.
EPA will accept public comments on the revised risk determination for 30 days following publication in the federal register via docket EPA-HQ-OPPT-2016-0725 at www.regulations.gov.