EPA Finds PCE Poses Unreasonable Risks
The U.S. Environmental Protection Agency announced in a press release last week that it has finalized a revision to the Toxic Substances Control Act (TSCA) risk determination for perchloroethylene (PCE).
In its report, the EPA found that as a whole chemical substance, PCE presents an unreasonable risk of injury to human health when evaluated under its conditions of use. The Agency’s decision to revise the risk determination was reportedly developed in accordance with policy changes formally announced in June 2021.
The revision also aligns with the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity and regulatory review.
About PCE, Risk Results
PCE is used in the production of fluorinated compounds, as a solvent for cleaning and degreasing, and in lubricants, adhesives and sealants. Several consumer and commercial products, such as common adhesives, aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish and wipe cleaners, also use PCE.
In reviewing PCE in relation to the updated risk evaluations under TSCA, the EPA determined that the chemical presents an unreasonable risk to the health of workers, occupational non-users (workers nearby but not in direct contact with this chemical), consumers and bystanders.
Of the risks identified, the EPA noted that there were human health effects not related to cancer, such as neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to PCE. However, the Agency also found that PCE could cause cancer as a result of chronic inhalation and dermal exposures.
Overall, the EPA determined that 60 of the 61 conditions of use the EPA evaluated to drive the unreasonable risk determination.
While the revised risk determination for PCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE), the decision should not be viewed as an indication that the EPA believes there is widespread non-compliance with applicable Occupational Safety and Health Administration (OSHA) standards.
However, not assuming use of PPE in its baseline exposure scenarios reflects the EPA’s recognition that certain subpopulations of workers exist that may be highly exposed because:
Based on its decision, the EPA is planning to move forward with a risk management rulemaking.
Since proclaiming PCE poses unreasonable risks to human health, the next step in the process is to develop a risk management rulemaking to identify and apply measures that will manage these risks.
While the EPA has not conducted a new scientific analysis on this chemical, in revising the risk determination, the risk evaluation will continue to characterize risks associated with individual conditions of use in the risk evaluation of PCE to inform risk management.
The EPA has also shared in its release that it is planning to separately conduct a screening-level approach to assess risks from the air and water pathways for several of the first 10 chemicals, including PCE. The goal of this approach is to evaluate the surface water, drinking water and ambient air pathways for PCE that were excluded from the 2020 risk evaluation.
The assessment also intends to determine if there are risks that were unaccounted for in that risk evaluation. The findings are expected to be reported in the EPA’s proposed risk management rule for PCE.
In addition, the EPA expects to focus its risk management action on the conditions of use that drive the unreasonable risk but will not be limited to regulating specific activities found to drive unreasonable risk and may select from among a wide range of risk management requirements.
Other Recent Risk Updates, Notices
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:
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.
More recently, the EPA announced that it improved public access to certain reports submitted by chemical companies in its web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the TSCA, including new chemical notices and notices of substantial risk.
With the improvement to the application, known as ChemView, the EPA has published previously unpublicized new chemical notices received under TSCA section 5 and notices of substantial risk provided by companies under TSCA section 8(e).
TSCA section 5 requires the EPA to publish a list of new chemical submissions it has received, including premanufacture notices, significant new-use notices, microbial commercial activity notices, test market exemption applications, notices of commencement of manufacture or import and test information submitted under section 5.
This year, the EPA made more than 25,000 new chemical notice records received under section 5, including notices received between 2014 and 2019 that had not been published previously, available in ChemView.
The Agency added that it is planning to identify other older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA section 5 notices and TSCA section 8(e) reports on a near real-time basis.
In addition, the EPA has also published chemical health and safety studies received under TSCA section 8(d) on the platform. Regulations promulgated under TSCA section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of 50 specified chemical substances and mixtures.
More than 1,700 health and safety study records dating back to September 2021 have already been published in ChemView.
Regarding notices of substantial risk, under TSCA section 8(e), chemical companies are required to inform the EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. The EPA uses these notices to inform new and existing chemical risk assessment activities.
This year, the EPA shares that it has published 3,900 notices of substantial risk records received under TSCA section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between Jan. 1, 2019, and Dec. 20, 2021, that were not previously published due to resource limitations.
Moving forward, the Agency will publish all non-CBI versions of 8(e) notices received from Dec. 20, 2021, to the present, as well as additional notices received that are deemed completed within a week’s time.
The latest actions reportedly build upon the Agency’s commitment to enhance the transparency of its evidence-based scientific and policymaking processes related to the evaluation of potential risks posed by certain chemicals.