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Filed Comments Environmental Defense Fund Comments for Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals Review of the Draft Risk Evaluation of Trichloroethylene Docket ID: EPA-HQ-OPPT-2019-0500 Submitted March 18, 2020 Environmental Defense Fund (EDF) appreciates the opportunity to provide comments on the Environmental Protection Agency’s (EPA) draft risk evaluation for trichloroethylene (TCE) being prepared under section 6(b)(4) of the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Act, enacted on June 22, 2016.1 These comments are being submitted by EDF to assist the TSCA Scientific Advisory Committee on Chemicals (SACC) in its peer review of the draft risk evaluation for TCE. They have been prepared in the few weeks provided by EPA to submit comments for consideration by the SACC. EDF will also be providing oral comments at the SACC meeting scheduled for March 24-26, 2020. EDF reserves the right to supplement these comments at the SACC meeting and to provide additional comments on the risk evaluations on or before the comment period deadline of April 27, 2020. We request that these comments be immediately provided to the SACC for its review and consideration. Summary In its draft risk evaluation for TCE, EPA has grossly understated the risks from exposure to the chemical. EPA did more frequently identify unreasonable risks than in draft risk evaluations for other chemicals released in the past year, making the deficiencies harder to discern. EPA has employed a host of unwarranted and unsupported assumptions and methodological approaches that lead it to either avoid identifying unreasonable risk when it should have, or to understate the extent and magnitude of the unreasonable risks it did identify. Below we summarize some of the major concerns addressed in these comments. 1 U.S. EPA, Draft Risk Evaluation for Trichloroethylene CASRN: 79-01-6 (February 2020), https://www.regulations.gov/document?D=EPA-HQ-OPPT-2019-0500-0002. Further citations in these comments of the draft risk evaluation consist of only a page number in parentheses. 1 Exclusion of known uses and exposures: Once again, EPA has abdicated its responsibility under TSCA to identify and evaluate the risks the chemical presents to the general population, by excluding from its risk evaluation conditions of use and exposures that are known or reasonably foreseen, including exposures from releases of TCE to air, water, and land. EPA has also failed to consider exposure to background levels of TCE. See section 2 of these comments. Insufficient consideration of vulnerable subpopulations: EPA has not met its mandatory duty under TSCA to thoroughly identify and evaluate the risks to vulnerable subpopulations. These include, in addition to workers: subpopulations that are more susceptible to TCE exposure, including pregnant women and the developing fetus and diseased subpopulations including those managing kidney and liver disease; as well as consumers and others who may be at risk of cancer from acute exposures. See sections 1.A. and 4.A. of these comments. Failure to protect against the most sensitive endpoint, fetal cardiac malformations: EPA’s reliance on immune-related endpoints instead of fetal cardiac malformations for its determinations of acute and chronic risk deviates from scientific best practices, defies requirements under the law, ignores longstanding agency policy, and is not sufficiently protective of public health. See sections 4.C., D. and E. of these comments. Underestimation of occupational risks: Of particular concern is the extent to which EPA has underestimated occupational risks. EDF has analyzed each of the individual risk estimates EPA has made in this draft risk evaluation, which is presented in sections 5.A. and 7.A. of these comments. EDF’s analyses identify and quantify several major ways in which EPA has underestimated occupational risks, including through: EPA’s unsupported assumptions regarding worker use of personal protective equipment in many scenarios; its use of a cancer risk level for workers that fails to protect them as a vulnerable subpopulation as required by TSCA; its failure to consider combined exposures of workers from multiple sources; and its failure to identify unreasonable risks for the most highly exposed (and hence especially vulnerable) occupational non-users (ONUs). EPA’s exposure assessment has underestimated occupational exposures. See sections 5.A, 5.B., and 7.A. of these comments. Dismissal of risk by invoking uncertainty: EPA invokes uncertainty as an unwarranted basis for ignoring risks it has identified to the environment and to ONUs, and for not accounting for combined exposures to TCE. See sections 5.B.i., 5.E.i., 7.A.iii., and 7.B. of these comments. Failure to adequately evaluate environmental risks of TCE release and exposure: EPA has over- relied on predictions from physical-chemical properties and unwarranted assumptions to ignore or underestimate environmental risks, including to aquatic, sediment, and terrestrial organisms, EPA has also ignored available data on environmental releases. See section 6 of these comments. 2 Use of a flawed systematic review approach: EPA has continued to use its flawed TSCA systematic review approach that inappropriately downgrades epidemiological evidence, fails to provide and utilize a pre-established methodology for evidence integration, and selectively includes or excludes studies in a manner that reveals inconsistency and bias. See section 8 of these comments. These comments first provide some broad, cross-cutting concerns about the draft risk evaluation as a whole and then present additional comments in the approximate order of the scoping, risk evaluation and risk determination processes. The order of the comments does not imply relative importance. Table of Contents 1. Broad/cross-cutting concerns .....................................................................................................8 A. EPA has given insufficient consideration to vulnerable subpopulations. ............................8 i. Insufficient consideration of the unique susceptibility of pregnant women and the developing fetus........................................................................................................8 a. Dermal risk estimates do not account for women of childbearing age. ..................8 b. Insufficient acknowledgement of the importance of potential transfer through the blood-brain barrier ..............................................................................9 ii. Insufficient acknowledgment of variability in human susceptibility ..............................9 a. Failure to highlight key groups of susceptible individuals ......................................9 b. Lack of detail regarding the extent of genetic variation in key metabolic pathways ................................................................................................................10 iii. Failure to consider workers with compromised health ...............................................10 iv. Insufficient consideration of potential elevated respiration rates in exposed workers .........................................................................................................................10 B. EPA has overrelied on personal protective equipment and the adequacy of OSHA requirements. ......................................................................................................................11 C. The SACC must address the scientific consequences of EPA’s “policy” determinations. ...................................................................................................................16 2. EPA has inappropriately or illegally excluded conditions of use and exposures. ...................18 A. EPA failed to analyze certain reasonably foreseen conditions of use. ..............................18 B. EPA has inappropriately excluded exposures based on other statutes. .............................19 C. EPA’s failure to consider general population exposures to TCE ignores numerous major exposure pathways. ..................................................................................................21 3 D. EPA needs to analyze those potentially exposed or susceptible subpopulations that face greater exposure due to their proximity to conditions of use. ....................................22 E. EPA has failed to consider exposure to background levels of TCE. .................................23 F. EPA excluded a number of workplace-related exposure scenarios. ..................................24 3. EPA is justified in adopting a linear, no-threshold approach for TCE’s carcinogenicity. ........................................................................................................................26 A. There is strong support for TCE’s cancer classification and a mutagenic mode of action for kidney cancer. ....................................................................................................26 B. The scientifically sound and health-protective approach is to use linear extrapolation in cancer dose-response modeling for TCE. ................................................27 i. Justification based on existing guidance .....................................................................27 ii. Justification based on human population variability and other real-world considerations to protect public health........................................................................28 4. EPA’s human health hazard
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