EPA Finds PV29 Poses Unreasonable Risks


On Tuesday (Sept. 6), the U.S. Environmental Protection Agency announced that it had finalized a revision to the risk determination for C.I. Pigment Violet 29 (PV29).

In an emailed press release, the EPA noted that PV29—as a whole chemical substance—presents an unreasonable risk of injury to human health when evaluated under its conditions of use.

As an intermediate, PV29 is used:

  • To create or adjust color of other perylene pigments;
  • In paints and coatings in the automobile industry;
  • In plastic and rubber products in automobiles and industrial carpeting;
  • In merchant ink for commercial printing; and
  • In consumer watercolors.

PV29 Risk Evaluation History

In 2016 the Toxic Substances Control Act (TSCA) got its first upgrade in 40 years as part of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which now requires the EPA to test all of the chemicals that had gotten through the previously weak TSCA (about 85,000 untested chemicals) with a target of about 2,000 a year.

First, chemicals were sorted into “high” and “low” priority categories. No further action was taken with chemicals considered to be “low priority,” but “high priority” chemicals moved on to a risk evaluation.

The risk evaluation first looks at all possible uses of a chemical (everything from how it’s manufactured to how it’s used and how it’s disposed of). Then, it will look at how many possible ways it can come into contact with people and the impact it will have. After its possible exposure is totaled, the EPA will then look at the impact it will have on society’s most vulnerable, such as children, industry workers or the environment. This step has to be concluded within three years. If the EPA thinks it needs more time for analysis, it can extend the process one additional year.

After the evaluation is complete, the EPA decides whether or not to regulate the chemical. If the chemical is deemed unsafe, the EPA then has two years to specify restrictions. This timeframe can also extend an additional year.

In December 2016 the EPA designated the first 10 substances up for evaluation, which included:

  • 1, 4 Dioxane;
  • Methylene Chloride;
  • 1-Bromopropane;
  • N-Methylpyrolidone;
  • Asbestos;
  • Pigment Violet 29;
  • Carbon Tetrachloride;
  • Trichloroethylene;
  • Cyclic Aliphatic Bromide Cluster (HBCD); and
  • Tetrachloroethylene.

In June 2019, the focus turned to PV29 with a review meeting.

PV29 is described in the Chemical Data Reporting database as:

“Approximately 90% of the domestic production volume of C.I. Pigment Violet 29 in 2015 (approximately 530,000 lbs.) was processed as a site-limited intermediate for the manufacture of other perylene pigments, while 10% of the production volume (approximately 60,000 lbs.) was processed and used in either commercial paints and coatings (approximately 30,000 lbs.) or commercial plastic and rubber products (approximately 30,000 lbs.). An unknown volume of C.I. Pigment Violet 29 is used in consumer watercolor and acrylic paints.”

“This will be an important opportunity for the science experts on this new committee to provide their scientific and technical advice to EPA,” said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn.

“This peer review ensures scientific rigor and enhances transparency of the risk evaluation process.”

The purpose of that meeting was for the EPA to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment and risk characterization.

In November 2020, the EPA announced that it released a revised draft risk evaluation for PV29 after receiving “additional data on PV29 in response to test orders, and the sole U.S. manufacturer of this chemical voluntarily submitted additional information to the agency” since its first draft was released in 2018.

That information was reportedly used to revise the draft risk evaluation.

“This new data led the EPA to revise its analytical approach for evaluating the potential exposure and health effects of PV29,” the agency said. “As a result of this updated analysis, the revised draft risk evaluation now shows unreasonable risk to workers for 11 out of 14 conditions of use. Because this new data had a significant impact on EPA’s risk evaluation and ultimately the risk determinations, the agency is providing an opportunity for the public and independent, scientific experts to give input before the risk evaluation is finalized.”

At the time, the EPA announced that it would be receiving public comments on the revisions until Nov. 30, 2020. Meanwhile, the EPA also planned to conduct a letter peer review of the revised draft risk evaluation using independent scientists, including one who served as a member and several who served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals.

The deadline for comments was later extended by 20 days to Dec. 19, 2020.

After completing its final risk evaluation in January 2021, the EPA reported 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. 

However, four out of the 14 conditions were found not to drive unreasonable risks, 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.

The following month, the EPA requested further comments on both the TSCA Fees Rule and its potential rulemaking for PV29. Under both request notices, the EPA said that the comments received would be considered in its rulemaking process, and that both were supposed to reach completion later that year.

Earlier this year, in February, the EPA was requested by the Society of Collision Repair Specialists (SCRS) and the Color Pigments Manufacturers Association (CPMA), in separate letters, to reconsider its final risk evaluation regarding PV29.

What Now

Upon using the whole chemical risk determination approach for PV29 in August, the EPA has recently shared that there are health effects associated with PV29 exposures for occupational non-users and workers who handle PV29 as part of their jobs.

The effort is noted to put the EPA in a better position to achieve its TSCA objectives. The EPA added that 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.

Additionally, the Agency noted that its recent 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.

While there could be occupational safety protections in place at workplace locations, not assuming use of PPE reflects the EPA’s recognition that unreasonable risk may exist for subpopulations of workers.

“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,” wrote the Agency in an emailed press release.

“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.”

With this latest update on PV29, the EPA will be moving forward on risk management to better protect workers, and is planning to 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.

The 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.


Tagged categories: Coating Materials - Commercial; Construction chemicals; Environmental Controls; Environmental Protection; Environmental Protection Agency (EPA); EPA; Good Technical Practice; Government; hazardous materials; Hazards; Health & Safety; Health and safety; NA; North America; Pigments; Regulations; Safety

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