EPA’s PV29 Final Rule Slated for This Summer
The Environmental Protection Agency (EPA) plans to finalize its revised risk determination on the chemical CI Pigment Violet 29 (PV29) this summer, which, if progressing as proposed, would take a “whole chemical approach” and establish regulations based on the assumption that PPE is not worn.
APE Spokeswoman Cathy Milbourn told Repairer Driven News that the agency’s next step would be to “propose a risk management rule for PV29 as part of the risk management phase of the process.”
PV29 is used as a pigment in paints, coatings and plastics, primarily in vehicles and industrial carpets. The EPA evaluated PV29 under the Toxic Substances Control Act Amendments (TSCA) and released its final risk assessment in January 2021, which states that PV29 poses “unreasonable risks to workers and non-professional users from 10 conditions of use. The agency concluded there was “no unreasonable risk” to consumers, bystanders, the general public or the environment.
“The Draft Revised Risk Determination proposes to find that PV29, as a chemical as a whole, poses an unreasonable risk of harm to health when evaluated under its conditions of use,” Milbourn said. . “APE proposes to use the whole chemical hazard determination approach for PV29 in part because [to] benchmark exceedances for multiple human health conditions of use and irreversible health effects (specifically lung toxicity effects known as alveolar hyperplasia, or an undesirable increase in the number of cells in the lungs where oxygen transfer occurs) associated with exposures to PV29.
However, in March APE released its Draft Revised Risk Determination for PV29 which also indicates that the chemical poses a risk of injury. Public comments were received on the draft from March 7 to April 21. Fourteen comments are posted on the EPA website, including opposition from the Alliance for Automotive Innovation (AAI), the American Coatings Association (ACA), and the CPMA.
“These subsequent risk assessment and risk determination policy changes, including the ‘Big Chemistry Approach’, will result in unreasonable and unwarranted risk determinations for many safe uses at the assessment stage,” AAI wrote. . “…Auto Innovators has several concerns with this draft revision, including: (i) specific assumptions about the use and handling of PV29 in the automotive sector and the EPA’s apparent disregard for previous comments submitted on the use of PV29 in the automotive sector, and (II) the application of new policy approaches for risk assessments and related consequences.
The ACA said in its comment submitted to the EPA that “the new policies did not materially change the risk assessment.”
“The new administration has adopted and endorsed the flawed scientific reasoning of the Trump administration in finalizing the current revised assessment of PV-29. To comment on the entire chemical approach and the absence hypothesis of PPE, it is necessary to briefly review the findings of the previous administration.”
The CMPA noted that “the scope of the new EPA policy regarding worker protection assumptions is unclear.”
“Furthermore, this policy violates TSCA, which requires the EPA to make risk assessment and determination decisions based on the particular circumstances of each condition of use of the affected chemical, guided by the best available scientific data. . In any event, this issue is not relevant to the PV29 risk assessment, as the final risk assessment did not determine “not unreasonable risk” based on the assumption that the workers were using personal protective equipment. »
A March EPA press release says the project was developed in accordance with EPA policy changes made in 2021 “as well as Biden-Harris administration executive orders and other guidance, including those on environmental justice, scientific integrity and regulatory review”.
The statement also notes that the EPA has not conducted “new scientific analysis on this chemical and the risk assessment continues to characterize the risks associated with individual use conditions in the risk assessment of PV29.”
“The Agency’s goal is to engage with stakeholders to develop a rule for PV29 that is both practical and protective of human health,” Milbourn told RDN. “APE welcomes information regarding effective means to address unreasonable risk, including exposure controls currently in place, as well as any information regarding essential uses, uses that have been phased out, and how any regulations may have an impact on the supply chain. Other information that would be useful when managing risks includes safer and more effective alternatives, either chemical substitutes or alternative processes. APE will review the information received and propose a rule for public comment.
The SCRS considers that any hazard associated with exposure to PV29 should be identified at the manufacturer level. CSIS Executive Director Aaron Schulenburg wrote in a Feb. 8 letter to the EPA that no scientific studies indicate there is exposure to nanoparticles when applying paint from any support, because collision repairers only mix liquids, not pigments.
The company, CPMA, and others have been invited to serve as Small Entity Representatives (SERs) on the Small Business Advocacy Review Panel (SBAR Panel) for EPA’s regulatory action, “Color Index Pigment Violet 29 ( PV29), Rulemaking under TSCA Section 6 (a).” The panel has not been asked to take recent action.
Along with his December 15 letter to the EPA, CMPA Executive Director David Wawer included a report from Ramboll US Consulting regarding the “Airborne Particle Size Characterization of CI Pigment Violet 29 (PV29), he wrote definitely shows that the workers and non-professional users of DCL Corp.’s Bushy Park facility. are not exposed to PV29 particles in the ultrafine range that the EPA has found to pose health risks.
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