The U.S. Environmental Protection Agency (EPA) has launched the first effort under the recently amended Toxic Substances Control Act (TSCA) to restrict or ban a chemical. The new proposed rule, which was sent for Office of Management and Budget review in late July but is not yet available to the public, seeks to address perceived risks to workers and consumers exposed to the once-prevalent degreaser, tricholoroethylene (TCE). EPA has not attempted such a TSCA Section 6 regulation in 25 years, since its efforts to ban asbestos were derailed in 1991.
Manufacturers and other facilities that use TCE in their operations should consider engaging in the regulatory process, in particular to provide EPA data that may show minimal potential for worker or consumer exposure to TCE (and, therefore, minimal risk) with respect to the degreasing and spot cleaning applications at issue in the rule. Companies also may want to explore the potential for using alternative degreasing chemicals or processes, in the event that EPA does move forward with restrictions or a possible ban. In June, EPA signaled that it intends to issue the proposed TCE rule by the end of 2016 and a final rule in late 2017.1
At one time, TCE was widely used as a metal parts degreaser and spot cleaning solvent. Over the last two decades usage has declined significantly due to the development of alternatives prompted by the emergence of studies associating exposure to TCE with a variety of adverse health effects, including cancer and Parkinson’s disease, as well as developmental toxicity impacts. In 2014, EPA issued an analysis concluding that TCE posed significant risks to workers exposed during degreasing and spot cleaning in small commercial operations.
TCE usage has declined in recent years, and reportedly has not been meaningfully used for spot cleaning at dry cleaning operations since 2000, though aerosol and vapor degreasing uses remain. The Environmental Defense Fund reports that over 255 million pounds of TCE are manufactured in or imported into the United States each year. The EPA’s Toxic Release Inventory (TRI) database shows that over 110 million pounds of TCE were managed as waste in 2014 at 183 manufacturing sites.2
In June, the first-ever amendments to TSCA since its adoption in 1976 were signed into law, fundamentally transforming the nation’s primary law for managing chemicals. With the revised TSCA, chemicals are evaluated against a new safety standard to determine whether they pose an “unreasonable risk” to human health or the environment under specified conditions of use. Cost is not a factor at the risk evaluation stage. Accordingly, EPA must first determine that the specified uses of TCE (as a metal degreaser in both consumer and industrial applications, and as a spot cleaning solvent) pose an “unreasonable risk” to human health before imposing restrictions, or a possible ban.
One of the key issues in the risk determination is the potential for exposure. For degreasing applications, questions already are being raised as to whether the agency is relying on accurate and current data regarding potential TCE exposures to workers and consumers.
If unreasonable risks are identified, EPA must take final risk management action within two years (with an extension to four years possible). Costs and the availability of alternatives are to be considered when determining appropriate risk management actions. Action, including bans and phaseouts, must begin as quickly as possible, but no later than five years after issuance of the final risk management regulation. Critically, the new TSCA eliminates the prior mandate that EPA adopt the “least burdensome” means of regulating a chemical, whereby the agency had to establish that a chemical risk could not be mitigated by any other regulatory means. This proved to be the fatal flaw in EPA’s efforts over the last 40 years to take action against chemicals found to present an unreasonable risk, including the infamous case involving asbestos.
Kelley Drye has extensive experience providing counsel to consumer good and manufacturing clients on compliance with TSCA and associated state requirements. We would be happy to assist your company in assessing the potential impact of the proposed TCE rulemaking or new TSCA in general on your business operations, including developing an appropriate compliance program. For more information about this client advisory or TSCA, please contact:
Joseph J. Green
Kelley Drye’s Environmental Law Practice Group specializes in providing comprehensive solutions to complex problems. We provide both advice and representation for clients participating in rule-making and policy-making activities by federal regulatory agencies, including the U.S. Environmental Protection Agency and the Occupational Safety & Health Administration, and similar state agencies. We have decades of experience advising companies and industry trade organizations with respect to chemical management requirements and related compliance and litigation matters.
 EPA has a similar schedule planned for rules to address methylene chloride and n-methyl pyrrolidone in paint removers.
 Facilities that manufacture or process over 25,000 pounds, or otherwise use over 10,000 pounds, of TCE in a given year are required to file TRI reports with EPA. Hence, many other facilities that use smaller amounts of TCE are not included in the TRI database but will be affected by any effort to restrict or ban uses of TCE.