EPA Updates Risk Evaluation on PV29


The U.S. Environmental Protection Agency announced late last week that it has released a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act.

What’s All This About

In 2016 the 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 will be sorted into “high” and “low” priority categories. No further action is taken with chemicals considered to be “low priority,” but “high priority” chemicals then move 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.

What Now

The EPA said in an emailed press release that, after initially issuing the draft risk evaluation in November 2018, it “received 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.”

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.”

Now, the EPA is accepting public comments on the revised draft risk evaluation until Nov. 30.

Meanwhile, the EPA will conduct a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals, the EPA notes. Biographical sketches of the peer reviewers will be available in the docket. The peer review will focus on charge questions supplied by the agency, and the public is encouraged to focus their comments on those issues as well.

The EPA says it will use this feedback to inform its final risk evaluation.


Tagged categories: EPA; EPA; Health & Safety; Health and safety; NA; North America; Pigments; Regulations; Safety

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