Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) - Review of Risk Evaluation for Trichloroethylene

Comments submitted by Richard A. Denison, Ph.D., Lead Senior Scentist, on behalf of the Environmental Defense Fund (EDF). See nine (9) attached files. Attachment 1: EDF TCE Comments for EPA FINAL 4-27-20.pdf Attachment 2: EDF TCE Appendix 1 Need to affirm fetal heart defects as key risk driver.pdf Attachment 3: EDF TCE Appendix 2 Worker Blogs.pdf Attachment 4: EDF TCE Appendix 3 Superfund NPL sites list.pdf Attachment 5: EDF TCE Appendix 4 History of TCE assessment peer review.pdf Attachment 6: EDF TCE Appendix 5 Runyan_et_al-2019-Birth_Defects_Research.pdf Attachment 7: EDF TCE Appendix 6 Analysis of DRE Table 4-54 Occ Risk.xlsx [MS Excel file] Attachment 8: EDF TCE Appendix 7 Petitioners' Opening Brief.pdf Attachment 9: EDF TCE Appendix 8 Petitioners' Reply Brief.pdf

To Whom It May Concern, Attached, please find the signatures of 17,321 EDF supporters from across the country who have submitted electronic comments regarding EPA's Draft TSCA Risk Evaluation of Trichloroethylene. The comment the each submitted reads: "I am deeply concerned by the extremely flawed draft risk evaluation that EPA has released on trichloroethylene (TCE), in addition to the agency's decision to abandon the previously- proposed bans on high-risk uses of TCE. Your draft risk evaluation dramatically underestimates the magnitude of TCE's risks, including in the following ways: It wrongly ignores over 3 million pounds of TCE annually released into air, water, and land because of a false and illegal assertion that they are adequately addressed under other statutory authorities. It excludes fetal heart defects - the most sensitive health outcome affecting the most sensitive group - from all of its determinations of health risks of TCE exposure - granting a long-held wish of the chemical industry that ignores decades of scientific research. EPA's decision to ignore many known sources of exposure and to dismiss or downplay the risks of this chemical will severely understate its actual threat to public health and jeopardize American lives. This assault on the Toxic Substances Control Act goes against the science that informs what we know about how chemicals like TCE can affect our health and the environment. The science tells us that the combined, long-term, and even low-level exposures resulting from multiple uses and sources of exposure to a chemical are what matters. It is critical that EPA abandon its flawed approach and comprehensively assess exposures to this toxic chemical and consider its detrimental impacts on fetal development in order to protect health - including the health of the most vulnerable among us." Please feel free to contact me if you have any questions or concerns about this submission. Sincerely, Heather Shelby Manager, Grassroots Organizing & Activism Environmental Defense Fund

Filed on regulations.gov — full text not in the inline record.

Filed on regulations.gov — full text not in the inline record.

Comment regarding the Science Advisory Committee on Chemicals (SACC) Mar 24-27, 2020 virtual meeting, submitted by Dr. Richard A. Denison, Lead Senior Scientist, on behalf of Environmental Defense Fund. For the record: Two members of the peer review panel for this week's Science Advisory Committee on Chemicals (SACC) virtual meeting to review EPA's draft risk evaluation of trichlorotheylene were not able to attend any of the meeting. Both of their names - Dr. Sheela Sathyanarayana and Dr. Dale Hattis - appear on the list of panelists in the final roster for this meeting, which is posted to this docket (https://www.regulations.gov/document?D=EPA-HQ-OPPT-2019-0500-0053). Dr. Sathyanarayana is an MD and epidemiologist with expertise in reproductive and child development. Dr. Hattis is a geneticist with expertise in physiologically based pharmacokinetic (PBPK) modeling of chemical exposures. Their absence was not made apparent to other panelists or the public because their names were excluded from the roll calls conducted by the SACC Chair before each morning and afternoon session during each of the four days of the meeting. After this omission occurred during both of Tuesday's roll calls and again on Wednesday morning, I brought our concern about their names not being called to the attention of the SACC Chair and the Designated Federal Officer (DFO) for this peer review. I was told that because they were not attending, their names would not be included in the roll call. This misses the point that public transparency is needed as to which panel members are -- and are not -- able to participate, which is why I am submitting this comment for the record. It should also be noted that a number of other panel members with unique/particular expertise were not able to participate on certain days or in certain sessions over the course of the week. EPA should make this information on participation available in the docket. The issues raised here are particular concerns given EPA's decision to proceed with a virtual meeting during the COVID-19 crisis instead of an in-person meeting or a virtual meeting held later.

Please find attached EDF's oral comments provided on March 24, 2020 during the TCE SACC peer review meeting. (Also available at the following link: http://blogs.edf.org/health/files/2020/03/EDF-Oral-Comment_TCE-SACC-Meeting-1.pdf.)

EDF comment for SACC consideration on need to affirm fetal heart defects as key TCE risk, submitted by Dr. Richard A. Denison, Lead Senior Scientist, on behalf of Environmental Defense Find. Please see attached document.

Filed on regulations.gov — full text not in the inline record.

Request regarding SACC Mar 24-27, 2020 virtual meeting, submitted by Dr. Richard A. Denison, Lead Senior Scientist, on behalf of Environmental Defense Find. Please see attached letter.

Comments submitted by Richard A. Denison, Ph.D., Lead Senior Scientist, on behalf of Environmental Defense Fund. Please find five (5) documents attached: 1. EDF comments on TCE draft risk evaluation for SACC consideration 2. EDF TCE Appendix 1: History of TCE assessment peer review 3. EDF TCE Appendix 2: TCE Superfund NPL sites list 4. EDF TCE Appendix 3: Runyan_et_al-2019-Birth_Defects_Research 5. EDF TCE Appendix 4 Analysis of DRE Table 4-54 Occ Risk (Excel spreadsheet)

Comment from Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund Submitted March 16, 2020 EPA needs to postpone next week's peer review of its draft risk evaluation of trichloroethylene As we all deal with an emerging major health crisis, it is critical that the quality of ongoing work on other issues vital to protecting public health is not sacrificed or compromised as a result. Given this, we strongly urge EPA to postpone next week's peer review of its draft risk evaluation of trichloroethylene. A few short weeks ago, EPA issued a draft risk evaluation for a highly toxic chemical, trichloroethylene or TCE. The draft is many hundreds of pages long (thousands of pages counting supplemental files). EPA also scheduled the peer review by the Scientific Advisory Committee on Chemicals (SACC) for next week, March 24-27. Even before the COVID-19 crisis, the time frame EPA provided for getting meaningful expert review of this important document was already questionable. Now it is simply untenable. As of now, EPA intends to proceed with the meeting as a virtual meeting. While traveling to a meeting next week should of course be off the table, proceeding with a virtual meeting at this point is asking far too much of SACC members and their families and will clearly lead to a severely compromised peer review. Consider, for example: SACC members who are dealing with their own and their families' health and well-being, are now being asked to spend dozens of hours over 4 days next week trying to participate in the virtual meeting. We all know how hard that is to do under normal circumstances. It is unrealistic and unfair to expect it under our current circumstances. Some SACC members are themselves members of the public health community that are responding to the COVID-19 crisis. Many or most SACC members are faculty at colleges and universities, and hence are likely already grappling as part of their day jobs with a shift to online teaching. SACC members are being expected to have found the time in these recent chaotic days to have read these massive documents, draft initial comments and be prepared to discuss all of this next week. Stakeholders are preparing comments for the SACC's consideration, which are due this Wednesday. SACC members are expected to review these materials on top of everything else. Stakeholders from health and labor groups who have been participating in the risk evaluation process by providing comments to the SACC as well as EPA are presently consumed with addressing COVID-19 issues facing their members and constituents. As we are learning in real time during this unfolding health crisis, ensuring there is sound expert input into public health decisions is absolutely essential. We cannot let the current crisis result in a weakening of the quality and credibility of scientific input on other important public health issues. EPA needs to promptly postpone the SACC peer review of TCE and reschedule it at a time and in a manner that respects the critical role the SACC plays.

Environmental Defense Fund (EDF) public comment delivered during the EPA SACC Virtual Preparatory Meeting on the Draft TCE Risk Evaluation (March 3, 2020), provided by Jennifer McPartland, PhD (Senior Scientist, EDF Health).