Kelly Franklin | Chemical Watch
Solvent’s TSCA workplan risk assessment comes under fire.
Industry groups have urged the EPA to delay regulatory action on the solvent trichloroethylene until the agency has completed its evaluation of the substance under the new TSCA.
This is according to comments submitted to the agency last month on its proposed TSCA section 6 rule that would ban the substance’s use as an aerosol degreaser and for spot cleaning in dry cleaning facilities.
NGOs say the science strongly supports that the uses of TCE subject to the rule present unreasonable risks and that the agency’s proposed bans are necessary to meet its statutory obligations to impose requirements to limit these.
But broader comments submitted by industry say the EPA failed to meet statutory requirements of the recently reformed TSCA in its first attempt to ban a substance under section 6 in close to thirty years. These comments were largely echoed in others more specific to the TCE rulemaking.
Risk assessment validity
The Halogenated Solvents Industry Alliance (HSIA) urged the EPA to withdraw the proposed rule on the grounds that it is based on a “very deficient risk assessment”.
Central to the lobby group’s position is that the TCE workplan risk assessment does not comport with ‘best science’ requirements under section 26 of the new law. It says that the assessment “expressly relied” on a non-cancer risk study that has been “heavily criticised in the published literature”.
Other studies have failed to reproduce the effects seen in the study, it said, and separate regulatory agencies — including the California EPA — have rejected the study as “deficient”.
While the agency is permitted to propose a section 6 rule for a substance based on an assessment conducted under the old TSCA, the HSIA said, it would be a “better course” for it to assess the risks from these applications in its upcoming evaluation of TCE under the new law.
The American Chemistry Council also cited “significant concerns” with the validity of the Johnson et al study that demonstrated non-cancer foetal heart malformations. Given that these have not yet been resolved, it said, the results of the study should not be incorporated into the rulemaking.
But the Environmental Defense Fund said that the science issues associated with the study have been “amply vetted, peer reviewed and should be considered resolved”.
It also noted that while the Johnson study was used to derive the reference concentration, “many studies — including human, animal and mechanistic — indicate foetal cardiac effects resulting from TCE exposure.”
The HSIA submitted multiple requests to the EPA to delay the comment deadlines for two proposed bans on TCE in order to reproduce this study. Its requests came under fire from NGOs, which noted the study in question was completed over a decade earlier and that industry has had sufficient time to replicate it.
The agency extended both deadlines by 30 days. In more recent comments, the trade group has told the EPA that due to laboratory errors the study has not been completed in time.
Comments for a rule governing TCE’s use in vapour degreasing are due later this week.
Alternatives and costs questioned
The new TSCA requires the EPA to consider when prohibiting or restricting specific uses of a chemical whether “technically and economically feasible alternatives” will be reasonably available when the proposed restriction takes effect.
The Consumer Specialty Products Association (CSPA) said many TCE uses have shifted to other solvents, and “the few products that remain are niche, critical uses for which alternative viable solvents simply do not exist.” Water-based cleaners, as mentioned by the EPA in the proposed rule, are “ineffective and unsafe” for many of the uses of TCE-containing aerosol degreasers.
The lobby group said there are several industrial and commercial applications that “deserve serious consideration for ‘critical use’ exemptions”.
The Drycleaning & Laundry Institute (DLI) asked the agency to “correct” a statement in the proposed rule that “many other alternatives are available and equally effective” by removing reference to the alternatives being “equally effective”.
The National Cleaners Association, a retail dry cleaning trade group, agreed that alternatives to TCE are not as effective, may harm the garment, and are more time consuming to achieve similar results.
It said that banning TCE in these applications would result in an increased cost, equal to 4-5% of gross sales. This is in contrast to the EPA’s economic analysis, which said the agency “assumes that the users of TCE aerosol degreasers and TCE dry cleaning spot removers are not expected to incur any costs associated with any requirements that discourage or prohibit the use of TCE.”
The Association of Global Automakers – which was offering general comments on section 6 rules – said calculating costs and benefits off such an “unfounded assumption … lacks transparency and fails to follow sound economic analysis principles”.
It urged the agency to collect “reasonably ascertainable information from the regulated community”.
But the Institute for Policy Integrity at New York University School of Law said that the EPA’s economic analysis is “overwhelmingly cost-benefit justified”, as it generates an estimated $9.3m to $25m in annualised benefits while imposing only $170k in costs – based on cancer risks alone.