On December 14, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for perchloroethylene. Of the 61 conditions of use that EPA reviewed, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders. The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants. EPA found no unreasonable risks to the environment.

EPA’s next step in the process required by the Toxic Substances Control Act (TSCA) is to develop a plan to reduce or eliminate the unreasonable risks found in the final risk evaluation. EPA states that it “is moving immediately to risk management for this chemical and will work as quickly as possible to propose and finalize actions to protect against the unreasonable risks.” The potential actions that EPA could take to address these risks include regulating how perchloroethylene is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable. As with any chemical product, EPA “strongly recommends that users of products containing perchloroethylene continue to carefully follow all instructions on the product’s label and safety data sheet.”

Background

TSCA Section 6, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), requires EPA to conduct risk evaluations to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.” The statute identifies the minimum components EPA must include in all risk evaluations. For each risk evaluation, EPA must publish a document that outlines the scope of the risk evaluation to be conducted, which includes the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations that EPA expects to consider. Each risk evaluation must also: (1) integrate and assess available information on hazards and exposure for the conditions of use of the chemical substance, including information on specific risks of injury to health or the environment and information on relevant potentially exposed or susceptible subpopulations; (2) describe whether aggregate or sentinel exposures were considered and the basis for that consideration; (3) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use; and (4) describe the weight of the scientific evidence for the identified hazards and exposure. The risk evaluation must not consider costs or other nonrisk factors. A detailed summary and analysis of the final risk evaluation rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”

Risk Evaluation for Perchloroethylene

According to the final risk evaluation, EPA evaluated exposures to perchloroethylene in occupational and consumer settings. In occupational settings, EPA evaluated acute and chronic inhalation exposures for two subcategories of workers, occupational users (workers) and ONUs, and acute and chronic dermal exposures to workers. The final risk evaluation states that EPA used inhalation monitoring data from literature sources that met data evaluation criteria, where reasonably available. EPA also used modeling approaches to estimate potential inhalation exposures. EPA estimated dermal doses for workers in occupational exposure scenarios since dermal monitoring data were not reasonably available. In consumer settings, EPA evaluated acute inhalation exposures to both consumers and bystanders and acute dermal exposures to consumers. EPA estimated inhalation exposures for consumers and bystanders and dermal doses for consumers in these scenarios since inhalation and dermal monitoring data were not reasonably available.

EPA did not identify any “legacy uses” (i.e., circumstances associated with activities that do not reflect ongoing or prospective manufacturing, processing, or distribution) or “associated disposal” (i.e., future disposal from legacy uses) of perchloroethylene. Therefore, EPA did not add any such uses or disposals to the scope of the risk evaluation for perchloroethylene following the issuance of the opinion in Safer Chemicals, Healthy Families v. EPA. The final risk evaluation states that EPA did not evaluate “legacy disposal” (i.e., disposals that have already occurred) in the risk evaluation “because legacy disposal is not a ‘condition of use’ under Safer Chemicals.”

EPA made the following risk evaluation findings. EPA stated that in making these unreasonable risk determinations, it considered the hazards and exposure, magnitude of risk, exposed population, severity of the hazard, uncertainties, and other factors.

• EPA found unreasonable risk to workers, ONUs, consumers, and bystanders from 59 out of 61 conditions of use of perchloroethylene:

  • Consumers and Bystanders: EPA found unreasonable risks to consumers and bystanders from all consumer uses of perchloroethylene. Common consumer uses include as a dry cleaning solvent; in cleaning and furniture care products; automotive care products like brake cleaners, lubricants, and greases; and adhesives in arts and crafts. The risk to consumers from perchloroethylene’s use in dry cleaning is from short-term skin exposure to items cleaned with perchloroethylene; and

  • Workers and ONUs: EPA found unreasonable risks to workers from all but two occupational uses of perchloroethylene. Additionally, EPA found unreasonable risks from most commercial uses to workers nearby but not in direct contact with perchloroethylene (ONUs).This includes an unreasonable risk to workers and ONUs when domestic manufacturing or importing the chemical; processing as a reactant and intermediate; incorporation into cleaning and degreasing products; uses in a variety of industrial and commercial applications such as degreasing, dry cleaning, in adhesives and sealants, and in paints and coatings; and disposal. The primary health risk identified in the final risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene. The conditions of use in the final risk evaluation that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.

• EPA found no unreasonable risk to the environment for any conditions of use. EPA has determined that perchloroethylene does not present an unreasonable risk of injury to the environment (aquatic organisms) from all conditions of use, based on the risk estimates, the environmental effects, the exposures, physical-chemical properties, and consideration of uncertainties.

Commentary

We commend EPA on issuing the final risk evaluation for perchloroethylene. With the issuance of the final risk evaluation, risk management efforts will now commence covering the conditions of use for which EPA found unreasonable risk. A final Section 6(a) regulation is required to be issued within three and one half years, including potentially available extensions. In addition, for the two conditions of use that were determined not to present an unreasonable risk, these decisions, which have been issued by order under Section 6(i)(1), represent final agency actions that are subject to legal challenge. Generally consistent with the other risk evaluations issued to date, EPA did not evaluate hazards or exposures to the general population in the risk evaluation (i.e., from surface water, drinking water, ambient air, and sediment pathways) because those exposures fall under the jurisdiction of other environmental statutes administered by EPA. As a result, the unreasonable risk determinations for the relevant conditions of use do not account for exposures to the general population. Considering the legal challenges filed to date on the Section 6(i)(l) orders issued as part of final risk evaluations on methylene chloride and the cyclic aliphatic bromide cluster (HBCD), legal challenges to the order may arise for the conditions of use that EPA determined do not present an unreasonable risk, for reasons including but not limited to EPA’s exclusion of the general population exposure pathways.

Under TSCA Section 6(b)(4), EPA has three years to complete a risk evaluation, extendable for an additional six months; the deadline for the issuance of the risk evaluations for the “first ten” chemicals selected for risk evaluation under Section 6(b)(2)(A), as extended by six months by EPA, was June 19, 2020. EPA has to date completed risk evaluations on six of the ten chemicals: methylene chloride, 1-bromopropane, HBCD, carbon tetrachloride, trichloroethylene, and now, perchloroethylene. EPA has stated that the remaining risk evaluations on the “first ten” chemicals are expected by the end of 2020; this includes risk evaluations on 1,4-dioxane, asbestos, N-methylpyrrolidone, and C.I. Pigment Violet 29. Considering that the comment period for the supplemental analysis to the draft risk evaluation for 1,4-dioxane ended just on December 10, 2020, and that the comment period for the revised draft risk evaluation for C.I. Pigment Violet 29 will end on December 19, 2020, EPA’s issuance of each of the remaining four final risk evaluations by the end of year is daunting. Stakeholders will be under considerable pressure to raise their concerns timely and effectively and at an inconvenient time of year.