EPA Asked to Reconsider Pigment Risk
The U.S. Environmental Protection Agency has recently been requested to reconsider its final risk evaluation regarding C.I. Pigment Violet 29 (PV29).
The requests, issued by the Society of Collision Repair Specialists (SCRS) and the Color Pigments Manufacturers Association (CPMA) in separate letters, arrives as there is a shared belief that hazards associated with PV29 exposure should be identified at the manufacturer level.
“It is our belief that no testing has been done to date at the collision center level that proves that nanoparticles of PV29 are present,” SCRS Executive Director Aaron Schulenburg wrote in a letter dated Feb. 8. “… SCRS highly recommends that EPA perform more conclusive testing before pursuing implementation of any rule.”
Prior to Schulenburg’s letter, CPMA Executive Director David Wawer sent a request in December to conclude that there is no unreasonable risk in the downstream use of PV29 unless it involves agitation and dispersion of PV29 particles, citing a report by Ramboll US Consulting regarding the “Airborne Particle Size Characterization of C.I. Pigment Violet 29 (PV29)” and its relevance to the EPA’s Risk Management Rulemaking.
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.
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.
After completing its final risk evaluation in January 2021, 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.
While the EPA has stated that PV29 has “no unreasonable risk” to consumers, bystanders, the general population or the environment, its January 2021 ruling points out that the pigment poses “unreasonable risks to workers and occupational non-users from 10 conditions of use.”
Some of these conditions, however, have proven to affect the automotive paint and collision industries, among others. As a result, Schulenburg wrote to the EPA following Small Entity Representatives (SERs) meetings for the Small Business Advocacy Review Panel (SBAR Panel), reporting that the EPA didn’t seem to understand how collision repair businesses interact with automotive paint.
The issue seems to be with the formulation or mixtures of products in paint and coatings, however, SCRS members don’t purchase pigments or specific colors from the refinish manufacturer. Schulenburg also pointed out in his letter that repair facilities use OSHA-regulated safety measures, which would also reduce the risk of PV29 exposure.
“Collision repair businesses have access to Safety Data Sheets (SDS) from their refinish manufacturer for details surrounding product identification and composition,” Schulenburg wrote. “… To a collision repair facility, it is unclear if PV29 is currently identified within the SDS.”
In the letter sent by CPMA, Wawer included a report that he felt showed that workers and occupational non-users at DCL Corp.’s Bushy Park facility weren’t exposed to PV29 particles in the ultrafine range that the EPA found to present health hazards.
For the report, created by Ramboll US Consulting, airborne concentrations of particulates at Bushy Park, which according to CPMA is the only U.S. facility that manufactures PV29, were measured. The study also focused on the final stage in the batch production of PV29 – the one most likely to generate the highest concentrations, and smallest particle size of the chemical.
Wawer wrote that the most important finding of the study was “airborne [ultrafine particles] UFP were not generated as part of the PV29 grind and blend pack-out process” and that “[a]irborne ultrafine particle concentrations decreased throughout the monitoring period with a mean concentration [that] was less than the mean background concentration [that] was measured prior to handling PV29.”
As a result of the findings, CPMA believes it would be appropriate if the EPA concluded that there is no unreasonable risk in downstream use of PV29 unless that involves agitation and dispersion of PV29 particles, according to Wawer’s letter.
“Alternatively, EPA could encourage representatives of these downstream industries to conduct similar UFP monitoring at representative workplaces and provide the Agency with the results,” he wrote. “At an absolute minimum, the proposed risk management rule should provide facilities with the option of conducting initial monitoring at appropriate locations, comparable to that conducted by Ramboll, to determine whether ultrafine particles are observed to fluctuate in ways that correspond to activities involving PV29. Where no such correlation is observed, facilities would have no further obligations under the rule.”
According to reports, the SBAR Panel plans to convene and hold an outreach meeting with the SERs to go over the requests. This is to be followed by an additional opportunity to submit comments. No dates have been announced for these meetings at this time.