halogenated
solvents
industry
alliance, inc.

March 17, 2017

Office of Pollution Prevention & Toxics
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Att'n: Cindy Wheeler and Niva Kramek
Re: Docket No. EPA-HQ-OPPT-2016-0231
Docket No. EPA-HQ-OPPT-2016-0387
Dear Ms. Wheeler and Ms. Kramek:
I write on behalf of the Halogenated Solvents Industry Alliance, Inc. (HSIA) to seek an
extension of the comment deadline for a proposed rule on use of trichloroethylene (TCE) and a
proposed rule on use of methylene chloride (dichloromethane or DCM) that are the subjects of
the captioned dockets. HSIA represents producers and users of TCE and DCM and has been
actively involved in EPA's programs to assess and regulate TCE and DCM since its formation in
1980.
Comments on the proposed ban on TCE in vapor degreasing, 82 Fed. Reg. 7432 (January
19, 2017), as extended at 82 Fed. Reg. 10732 (Feb. 15, 2017), are due April 19, 2017.
Comments on the proposed ban on DCM in paint stripping, 82 Fed. Reg. 7464 (January 19,
2017) are also due April 19, 2017. We respectfully request that the comment deadline for both
proposals be extended by 120 days to August 17, 2017.
The two regulatory proposals are both based on risk assessments completed in
2014 that we submit are not "consistent with the scope of the completed risk assessment
for the chemical substance and consistent with other applicable requirements of § 6," as
required by Toxic Substances Control Act (TSCA) § 26(l)(4). They also raise many
common legal and policy issues (e.g., what constitutes "unreasonable risk," EPA's
authority to regulate the workplace).
With regard to TCE, moving the comment deadline to August 17 will allow for
the submission within the comment period of significant new scientific information
directly relevant to the rulemakings. The TCE proposal is driven by a toxicological value
derived from a developmental study by Johnson et al. (2003). For both acute and chronic
(non-cancer) risks, EPA determined that "the greatest risk is for developmental effects
(i.e., fetal cardiac defects)" as derived using Johnson et al. (2003). See 82 Fed. Reg.
7432, 7438-39. As EPA is aware, HSIA has sponsored a study at Charles River

3033 Wilson Boulevard, Suite 700 • Arlington, VA 22201
www.hsia.org

C:\Users\cnorman\Documents\Extension Request.docx

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March 17, 2017
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Laboratories.' This study was intended specifically to try to replicate the cardiovascular
effects seen by Johnson et al. (2003), which no laboratory to date has been able to
reproduce, in an EPA Guideline study that meets Good Laboratory Practices. The
Protocol was signed on October 6, 2016 and the in-life portion of the study was
conducted during October and November 2016. Unfortunately, we were recently notified
by the laboratory that the concentrations of TCE measured in the drinking water solutions
were found to be below the acceptable target range of 100% ± 10%, invalidating the
study. The laboratory has conducted additional studies to identify the source of the
deviation and the study will be rerun as soon as dosing methodological issues are
resolved and scheduling permits, with a target of having results available by August 17.
As opposed to EPA's proposed reliance on the so far unreproducible Johnson et al. study,
the results of this study will provide a record for EPA decision-making consistent with
the requirements of TSCA § 26(h) that § 6 rulemaking be based on the "best available
science."
With regard to DCM, we are aware that commenters are working with a number
of outside technical experts who will assist in addressing various elements of the EPA
proposal, including EPA's economic assessment, its hazard and exposure assessments,
and its alternatives. These analyses are time-intensive and require collaboration with
paint removal product manufacturers and users. Our goal is to prepare comments that
will provide the Agency with accurate and up-to-date information on the latest scientific
and economic developments with regard to both DCM-based and alternative paint
removal products so that the Agency can reach an informed decision. This extension
request in no way prejudices the Agency or its deliberation as we understand, based on
the language in the preamble to the proposed rule, that the Agency does not intend to
issue a final rule on paint stripper uses until EPA has also proposed and solicited
comments on a forthcoming rulemaking addressing use of these and similar products in
commercial furniture refinishing application. See 82 Fed. Reg. at 7465.
I note that this request is supported by EPA's recent action to extend by 120 days
the comment period on a draft notice of the rationale for granting petitions to add npropyl bromide (nPB), also known as 1-bromopropane (1-BP) (Chemical Abstract
Service No. 106-94-5), to the list of hazardous air pollutants contained in section
112(b)(1) of the Clean Air Act. 82 Fed. Reg. 12589 (Mar. 6, 2017). EPA made this
interim extension as an initial response to allow adequate consideration of a request to
extend the comment period by more than six months. The rationale for the extension
was: "According to EPA's [Toxics Release Inventory, or TRI] website, the preliminary
dataset for the July 1, 2017 TRI data will be available to the public in July, 2017. .
Extending the comment period to October 1, 2017, will insure that the TRI database for
nPB is part of this rulemaking, and will also provide the public with an opportunity to
review the TRI dataset for nPB usage, sources and emissions, and use that data to prepare
meaningful comments on the draft notice." We believe that our request provides an even
more compelling case for extension.

'Oral (Drinking Water) Study of the Effects of Trichloroethylene (TCE) on Fetal Heart Development in Sprague
Dawley Rats.

 Office of Pollution Prevention & Toxics
March 17, 2017
Page 3

We ask that you let us know as soon as possible whether EPA will grant the
requested extensions.
Very truly yours,

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Faye eraul
Executive Director