EPA Finds PV29 Poses Unreasonable Risks to Human Health
Released on September 6, 2022
Today, the U.S. Environmental Protection Agency (EPA) finalized a revision to the risk determination for C.I. Pigment Violet 29 (PV29), finding that PV29, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use.
Uses and Risks Associated with PV29
PV29 is used as an intermediate:
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To create or adjust color of other perylene pigments;
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In paints and coatings in the automobile industry;
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In plastic and rubber products in automobiles and industrial carpeting;
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In merchant ink for commercial printing; and
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In consumer watercolors.
In its revised risk determination based on the January 2021 risk evaluation (EPA-HQ-OPPT-2018-0604), EPA found that PV29 presents unreasonable risk to health of workers and occupational non-users from long-term inhalation exposure. Specifically, long-term exposure to PV29 can cause lung toxicity effects known as alveolar hyperplasia, or an adverse increase in the number of cells in the lungs where oxygen transfer occurs.
Overall, 10 of the 14 conditions of use EPA evaluated drive the unreasonable risk determination due to risks identified for human health. The unreasonable risk presented by PV29 is driven by exposures from manufacturing (including import), processing, certain industrial/commercial uses, and disposal.
Four out of 14 conditions of use do not drive the unreasonable risk, including 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.
EPA used the whole chemical risk determination approach for PV29 in part because there are risk benchmark exceedances for a significant number of conditions of use spanning across most aspects of the chemical lifecycle – from manufacturing (including import), processing, commercial and industrial use, and disposal. There are health effects associated with PV29 exposures for occupational non-users and workers who handle PV29 as part of their jobs. Thus, EPA is better positioned to achieve its TSCA objectives by issuing a whole chemical determination for PV29.
The revised risk determination supersedes the condition of use-specific no unreasonable risk determinations previously issued by order under TSCA section 6(i) in the January 2021 PV29 risk evaluation.
In addition, this determination does not reflect an assumption that workers always or appropriately wear personal protective equipment (PPE), even though some facilities might be using PPE as one means to reduce workers’ exposures. EPA’s decision not to assume that PPE is always and appropriately used should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable OSHA standards. In fact, EPA received public comments from industry respondents about occupational safety practices currently in use at their facilities. EPA will consider these comments, as well as other information on use of PPE and other ways industry protects its workers, as potential ways to address unreasonable risk during the risk management process.
EPA understands there could be occupational safety protections in place at workplace locations; however, not assuming use of PPE reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, or because OSHA’s chemical-specific Permissible Exposure Limits (largely adopted in the 1970’s) are described by OSHA as being “outdated and inadequate for ensuring protection of worker health” (as is the case for PV-29).
As EPA moves forward with a risk management rule for PV29, the agency will strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk. EPA will propose occupational safety measures in the risk management process that would meet TSCA’s statutory requirement to eliminate unreasonable risk of injury to health and the environment.
Next Steps for PV-29
EPA is now moving forward on risk management to protect workers, including those who handle PV29 as a part of their jobs, from the unreasonable risk presented by PV29. Note that in revising the risk determination, EPA has not conducted additional new scientific analysis on this chemical. The risk evaluation continues to characterize risks associated with individual conditions of use to inform risk management.
In June 2021, EPA announced a path forward for the first 10 chemicals to undergo risk evaluation under the Toxic Substances Control Act (TSCA) to ensure the public is protected from unreasonable risks from these chemicals in a way that is supported by science and the law.
The 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. EPA’s revisions ensure that the PV29 risk determination better aligns with the objectives of protecting health and the environment under the amended TSCA.
EPA expects to focus its risk management action on the conditions of use that drive the unreasonable risk. However, EPA is not limited to regulating the specific activities found to drive unreasonable risk, and may select from among a wide range of risk management requirements. 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.