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By Pat Rizzuto
Dec. 12 — Disputes about the adequacy of Environmental Protection Agency risk assessments have begun following the agency’s release of a proposed rule to ban two uses of a solvent.
The proposed rule, released Dec. 7, would ban the use of trichloroethylene (TCE; CAS No. 79‐01‐6) in aerosol degreasers, such as sprays designed to remove grease from electrical motors or metal. The agency estimated about 2,200 commercial facilities use one or more of at least 16 TCE-containing aerosol spray degreasers blended by six different firms.
The proposed rule also would ban TCE’s use for spot cleaning by dry cleaners.
The risk assessment upon which the EPA based its rule doesn’t meet the legal requirements of the law that amended the Toxic Substances Control Act, W. Caffey Norman, an attorney and partner with Squire Patton Boggs in Washington, D.C., told Bloomberg BNA in a recent interview.
Jim Jones, assistant administrator of chemical safety and pollution prevention at the EPA, told Bloomberg BNA the risk assessment absolutely meets the requirements of the amended chemicals law.
The agency’s rule (RIN:2070-AK03) marks two firsts.
The proposal is the first rulemaking the EPA has attempted since 1991 using the authorities it has under section 6 of the Toxic Substances Control Act. In 199,1 the U.S. Court of Appeals for the Fifth Circuit overturned the agency’s 1989 effort to ban most uses of asbestos ( Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 33 ERC 1961 (5th Cir. 1991)). Section 6 of TSCA gives the EPA authority to require labeling for, restrict uses of, ban or take other actions to control the risks of chemicals in commerce.
The TCE rule also is the first regulation the agency has proposed since TSCA was amended in June.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182), which amended TSCA, authorized the agency to proceed with rulemakings that were based on a handful of risk assessments the EPA completed prior to the law’s passage. The TCE risk assessment, completed in 2014, is among that handful.
The statutory authorization was necessary, because the narrow scope of the pre-Lautenberg Act risk assessments is not sufficient to meet the scope of the risk evaluations mandated by the law.
While the narrow scope is allowed, the risk assessments must meet the science quality standards established in Section 26 of the Lautenberg Act.
The EPA, for example, is required to use the best available science and a weight-of-evidence approach in all risk assessments including those completed before the Lautenberg Act became law.
Norman, John Bell from the Halogenated Solvents Industry Alliance, and the EPA’s Jones disagreed as to whether that TCE risk assessment meets the science mandate in Section 26.
Bell directs scientific programs for the Halogenated Solvents Industry Alliance, which represents manufacturers, producers, distributors and commercial users of halogenated solvents such as TCE.
“EPA should be embarrassed to propose this rule based on the risk assessment released in June 2014,” Bell said.
Bell quoted Penny Fenner-Crisp, who chaired the peer review committee that evaluated the draft TCE risk assessment.
Fenner-Crisp, a 22-year veteran of the EPA who served as a senior scientist in several agency offices, said: “I believe that the agency acted prematurely in issuing this (screening level) assessment for public comment and in convening a formal scientific expert peer review.”
“This begs for refinement of the assessments, on both the exposure and hazard side of the equation. This is essential for any defensible regulatory actions to be undertaken,” Fenner-Crisp wrote in the peer reviewers comments.
Norman, whose law firm represents the solvents industry alliance, told Bloomberg BNA: “This risk assessment does not meet Section 26 requirements.”
“It does not meet the best available science requirement,” he said.
Norman, whose law firm represents the Halogenated Solvents Industry Alliance, provided Bloomberg BNA with details about the alliance’s scientific and other objections.
For example, they said, the agency’s risk assessment relied on a California EPA study that may not be representative of U.S. dry cleaning facilities.
The computer exposure model and extent of professional judgment the agency used to estimate short-term, high exposures to TCE show the risk assessment was an initial, first attempt. The EPA should have followed this “screening level assessment: up with a more rigorous data-based analysis,” the alliance and law firm said.
Jones, who provided technical assistance crafting the Lautenberg Act including the Section 26 requirements, told Bloomberg BNA, “the science standards in Section 26 have long been the science standards we have followed in this program.”
“The risk assessments that were done before the law passed are going to meet the Section 26 standards to use the best available science,” he said.
Sen. Tom Udall (D-N.M.), who sponsored the Lautenberg Act, welcomed the agency’s proposed rule
“The EPA’s proposal to protect the public from a hazardous chemical in common use is exactly why we worked so hard for reform. It has been over a generation since the EPA has been able to do its job to protect the public from dangerous chemicals,” Udall said.
“Millions of Americans—including me—are regular customers at the neighborhood dry cleaner, but, like many chemicals, TCE has been on the market unchecked for many years despite evidence linking it to cancer and other serious health conditions,” Udall said. “Workers, customers and the communities around these businesses deserve to be protected and to be certain that there is an effective watchdog looking out for them. Everyone involved in public health and chemical manufacture has an interest in the success of this process, and I urge all sides to play a productive role moving forward.”
Nora Nealis, executive director of the National Cleaners Association, which represents dry cleaners, raised concerns about the proposed rules impact on thousands of small mom-and-pop businesses around the country.
In an interview with Bloomberg BNA, Nealis cited statics about these companies, operational costs, profit margins and other information to paint a picture of what she says could result from the proposed ban.
Neighborhood dry cleaners typically work 12 hours a day, six days a week, Nealis said. The dry cleaning employee, often the owner or a family member, earns about $35,000 a year, she said.
These companies use TCE to remove spots because it works well and quickly, saving labor and other costs such as heat and utilities to keep the shop open longer to do the same job with less effective substitutes, she said.
Suppose a shop treats just 12 garments a day, and the alternative solvent takes five minutes longer per garment than does TCE, she said.
That adds one hour a day to the spotter’s labor, an annual wage increase of $7,875, Nealis said.
That cost is hard to pass on to customers, who may respond by bringing their clothes in less often thereby reducing business, Nealis said.
An additional hour of work also is hard, when someone already works 12 hours a day, she said.
“It makes a difference in their lives,” she said.
Norman said the EPA’s rule exceeds the agency’s authority because it addresses work place and consumer uses of TCE.
The Occupational Safety and Health Administration is responsible for regulating the work place, while the Consumer Product Safety Commission regulates consumer products, he said.
“TCE already is well regulated,” Norman said.
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