In a proposed rule published on May 3, the U.S. Environmental Protection Agency recommended a ban on most uses of methylene chloride (also called dichloromethane), a common solvent and processing aid. It is used in a variety of consumer and commercial applications including adhesives and sealants, automotive products, and paint and coating removers. The chemical was manufactured in significant volumes — the total aggregate production volume ranged from 100 million to 500 million pounds between 2016 and 2019, according to Chemical Data Reporting (CDR) – so this ban, if promulgated, would have a substantial impact on many industrial sectors.
EPA’s proposal seeks to address “the unreasonable risk of injury to human health presented by methylene chloride under its conditions of use as documented in EPA’s risk determinations prepared under the Toxic Substances Control Act (TSCA).” TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so that the chemical no longer presents unreasonable risk.
In addition, the EPA’s proposed rule requires a workplace chemical protection program (WCPP), which would include a requirement to meet inhalation exposure-concentration limits and exposure monitoring for certain continued conditions of use of methylene chloride. It also would require recordkeeping and downstream notification requirements for several conditions of use, and provide certain time-limited exemptions from requirements for uses that would otherwise significantly disrupt national security and critical infrastructure.
Companies that manufacture, import, process, distribute in commerce, use, or dispose of methylene chloride or products containing methylene chloride may be potentially impacted by this proposed rule. Over 40 diverse categories of industry as listed by the proposed rule could fall within the ambit of this law, including: chemical merchant wholesalers; petroleum bulk stations and terminals; basic organic and inorganic chemical manufacturing; hazardous waste treatment and disposal; materials recovery facilities; paint and coating manufacturers; plumbing heating and air conditioning contractors; painting and wall covering contractors; automotive parts and accessories stores; electrical equipment and component manufacturing; welding and soldering equipment manufacturing; new and used car dealers; dry cleaning and laundry services; and doll, toy and game manufacturing.
The proposed rule does state that “an estimated 35% of the annual production volume of methylene chloride is for pharmaceutical uses, which are not subject to TSCA and would not be regulated by this rule.” Further, this proposed rule does not apply to any substance excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi). Those exclusions “include, … any food, food additive, drug, cosmetic, or device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device …”
For those industries that would be impacted by this ban, it is important to start considering alternatives. In EPA’s Alternatives Assessment for Use of Methylene Chloride, a number of alternatives were identified for various uses such as adhesives, caulk, degreasers, paint and coating removers, sealants, and lubricants and greases. Of note, however, no processing aid alternatives (among others) were identified. The Alternatives Assessment “does not make recommendations of products that should be used in place of methylene chloride; rather, its purpose is to present a representative list of alternative products and chemical ingredients and their hazard relative to methylene chloride to ensure that the screening results for potential alternatives are considered as part of regulations under TSCA section 6(a) for methylene chloride.” Comments to the proposed rule must be received on or before July 3, and can be submitted through the Federal eRulemaking Portal at https://www.regulations.gov.