The U.S. Environmental Safety Company (EPA) launched the final risk evaluation for trichloroethylene (TCE) on November 23, 2020. 85 Fed. Reg. 75010 (Nov. 24, 2020). Of the 54 situations of use that EPA reviewed, EPA discovered that 52 current an unreasonable threat to staff, occupational non-users (ONU), customers, and bystanders. EPA decided that distribution in commerce and shopper use of TCE in pepper spray don’t current an unreasonable threat. EPA additionally discovered no unreasonable dangers to the surroundings.
EPA’s subsequent step within the course of required by the Poisonous Substances Management Act (TSCA) is to develop a plan to scale back or eradicate the unreasonable dangers discovered within the last threat analysis. EPA states that it “is shifting instantly to threat administration for this chemical and can work to suggest and finalize actions to guard staff, occupational non-users, customers, and bystanders.” The potential actions that EPA may take to deal with these dangers embody regulating how TCE is used or limiting or prohibiting the manufacture, processing, distribution within the market, use, or disposal of TCE, as relevant. As with all chemical product, EPA “strongly recommends that customers of merchandise containing TCE proceed to fastidiously comply with all directions on the product’s label and security information sheet.”
TSCA Part 6, as amended by the Frank R. Lautenberg Chemical Security for the 21st Century Act (Lautenberg Act), requires EPA to conduct threat evaluations to “decide whether or not a chemical substance presents an unreasonable threat of harm to well being or the surroundings, with out consideration of prices or different nonrisk elements, together with an unreasonable threat to a doubtlessly uncovered or vulnerable subpopulation recognized as related to the chance analysis by the Administrator, beneath the situations of use.” The statute identifies the minimal elements EPA should embody in all threat evaluations. For every threat analysis, EPA should publish a doc that outlines the scope of the chance analysis to be performed, which incorporates the hazards, exposures, situations of use, and the doubtless uncovered or vulnerable subpopulations that EPA expects to contemplate. Every threat analysis should additionally: (1) combine and assess out there data on hazards and publicity for the situations of use of the chemical substance, together with data on particular dangers of harm to well being or the surroundings and knowledge on related doubtlessly uncovered or vulnerable subpopulations; (2) describe whether or not combination or sentinel exposures have been thought of and the premise for that consideration; (3) keep in mind, the place related, the possible period, depth, frequency, and variety of exposures beneath the situations of use; and (4) describe the load of the scientific proof for the recognized hazards and publicity. The chance analysis should not think about prices or different nonrisk elements. An in depth abstract and evaluation of the final risk evaluation rule is accessible in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”
Danger Analysis for TCE
Based on the ultimate threat analysis, EPA evaluated TCE’s occupational situations of use, together with the next classes: manufacture; import; processing as a reactant/intermediate; incorporation into formulation; combination or response product; integrated into articles; repackaging; recycling; distribution; solvents for cleansing and degreasing; lubricants and greases; adhesives and sealants; useful fluids in a closed system; paints and coatings; cleansing and furnishings care merchandise; laundry and dishwashing merchandise; arts, crafts, and pastime supplies; corrosion inhibitors and anti-scaling brokers; processing aids; ink, toner, and colorant merchandise; automotive care merchandise; attire and footwear care merchandise; different makes use of; and disposal. EPA evaluated the next classes of shopper situations of use: solvents for cleansing and degreasing; lubricants and greases; adhesives and sealants; cleansing and furnishings care merchandise; arts, crafts, and pastime supplies; attire and footwear care merchandise; and different shopper makes use of. Based on the ultimate threat analysis, in line with the choice on the drawback formulation stage, EPA excluded shopper makes use of of paint and coatings from the scope of the analysis.
EPA didn’t determine any “legacy makes use of” (i.e., circumstances related to actions that don’t mirror ongoing or potential manufacturing, processing, or distribution) or “related disposal” (i.e., future disposal from legacy makes use of) of TCE. Due to this fact, EPA didn’t add any such makes use of or disposals to the scope of the chance analysis for TCE following the issuance of the opinion in Safer Chemical compounds, Wholesome Households v. EPA. The ultimate threat analysis states that EPA didn’t consider “legacy disposal” (i.e., disposals which have already occurred) within the threat analysis “as a result of legacy disposal just isn’t a ‘situation of use’ beneath Safer Chemical compounds.”
EPA made the next threat analysis findings. EPA states that in making these unreasonable threat determinations, it thought of the hazards and publicity, magnitude of threat, uncovered inhabitants, severity of the hazard, uncertainties, and different elements.
- EPA discovered unreasonable dangers to human well being from 52 out of 54 situations of use of TCE:
- Shoppers and Bystanders: EPA discovered unreasonable dangers to customers and bystanders from all however one shopper use of TCE. Shopper makes use of embody cleansing and furnishings care merchandise, arts and crafts spray coatings, and automotive care merchandise like brake cleaners. EPA states that dangers to customers can come from short-term inhalation and dermal publicity. EPA notes that it didn’t discover shopper use of pepper spray to current an unreasonable threat; and
- Employees and ONUs: EPA discovered unreasonable dangers to staff from all occupational makes use of of TCE, apart from distribution in commerce. Moreover, EPA discovered unreasonable dangers from most industrial makes use of of TCE to ONUs. Based on EPA, frequent industrial makes use of are as a solvent in industrial cleansing/degreasing, an ingredient in adhesive/sealant removers, in paints and coatings, and in automotive care merchandise like brake cleaners. Dangers to staff and ONUs can come from each short- and long-term inhalation and dermal publicity.
- EPA discovered no unreasonable threat to the surroundings for any situations of use. EPA assessed the affect of TCE on aquatic and sediment-dwelling organisms by floor water and sediment exposures and to terrestrial organisms. After reviewing these information, EPA states that it discovered no unreasonable dangers to the surroundings.
The ultimate TCE threat analysis is exceptional due to the breadth of the situations of use for which EPA recognized unreasonable threat. EPA recognized exceedances of threat thresholds by inhalation and dermal exposures on the high-end and central tendencies, each with and with out protecting tools, and throughout well being endpoints, together with acute (developmental and immunosuppression), power, and most cancers endpoints — not simply restricted to the congenital coronary heart results that some have considered as controversial. Dangers have been discovered throughout shopper, industrial, and industrial situations of use for staff, ONUs, customers, and bystanders.
It stays to be seen how EPA will proceed with threat administration. Plainly all shopper makes use of of TCE, besides maybe for the pepper spray use, are prone to face a ban. Given the breadth of the dangers recognized by EPA for occupational situations of use, launch and publicity controls should be remarkably stringent to deal with the one-to-three orders of magnitude of exceedances for a few of the situations of use. The truth is, TCE often is the first of the primary ten threat evaluations during which EPA will think about significantly a broad ban for manufacturing, processing, and use. EPA will then have to guage whether or not technically possible options exist for TCE in every of its many makes use of.