IRIS Toxicological Review of Trichloroethylene (TCE) (External Review Draft)

Abstract

EPA is conducting a peer review and public comment of the scientific basis supporting the human health hazard and dose-response assessment of Trichloroethylene (TCE) that when finalized will appear on the Integrated Risk Information System (IRIS) database.
The draft Toxicological Review of Trichloroethylene (TCE) provides scientific support and rationale for the hazard and dose-response assessment pertaining to chronic exposure to TCE. TCE is a chlorinated solvent that has been widely used as a metal degreaser, as a chemical intermediate and extractant, and as a component of some consumer products. TCE is designated as a Hazardous Air Pollutant, is a common groundwater contaminant, and has been found at more than 1,500 hazardous waste sites. TCE enters the atmosphere from vapor degreasing operations or volatilization from contaminated soils, surface waters via direct discharges, and groundwater through leaching from disposal operations and hazardous waste sites. In addition, TCE can be released to indoor air from the use of TCE-containing consumer products, volatilization from water supplies, and vapor intrusion through walls and floors from contaminated soil and groundwater.

Impact/Purpose

The purpose of this Toxicological Review is to provide scientific support and rationale for the hazard and dose-response assessment in IRIS pertaining to chronic exposure to trichloroethylene. It is not intended to be a comprehensive treatise on the chemical or toxicological nature of trichloroethylene.

Status

Following external peer review the assessment will be revised taking into consideration external peer review and public comments, will undergo a final EPA internal review and a review by and science discussion with other federal agencies and White House offices, and will be posted to the IRIS database.

The final Trichloroethylene IRIS document is expected to be publicly available during the 4th quarter of FY 2011.

Citation

U.S. EPA. IRIS Toxicological Review of Trichloroethylene (TCE) (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-09/011A, 2009.

Date	Description
01- Aug 2001	EPA released an external review draft, Trichloroethylene Health Risk Assessment: Synthesis and Characterization for public review and comment.
02- Dec 2002	EPA's Science Advisory Board (SAB) released an independent peer review report Review of Draft Trichloroethylene Health Risk Assessment: Synthesis and Characterization: An EPA Science Advisory Board Report (PDF, 83 pp, 376 KB, about PDF).
03- Feb 2004	EPA hosts a Symposium on New Scientific Research Related to the Health Effects of Trichloroethylene held in Washington, DC.
04- Sep 2004	The National Academy of Science (NAS) initiated the project “Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues” under sponsorship of EPA and other federal agencies.
05- Feb 2005	EPA submitted four TCE issue papers on key scientific issues to the NAS.
06- July 2006	NAS released the report Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues Consultation.
09- Nov 2009	EPA released the draft Toxicological Review of Trichloroethylene (TCE) for public review and comment. Additionally, as per the new IRIS process, all comments received from federal agencies and White House offices on draft IRIS assessments will be made publicly available. Accordingly, interagency comments and the interagency draft of the TCE draft report have also been released. [Federal Register Nov 3, 2009]
10- Dec 2009	EPA announced a listening session to be held on January 26, 2010 in the Federal Register Dec 21, 2009, more details can be found in Federal Register Dec 11, 2009.
12- Jan 2010	SAB released the names and biosketches of the "Short List Candidates" for the upcoming TCE Review Panel.
13- Mar 2010	SAB hosted two public meetings of the SAB Trichloroethylene (TCE) Review Panel: a teleconference (4/20/10) and a face-to-face meeting (5/10-12) to review EPA's Toxicological Review of Trichloroethylene (External Review Draft). [Federal Register Mar 31, 2010]
14- Jun/Jul 2010	EPA's SAB announced two public meetings of the SAB Trichloroethylene (TCE) Review Panel: a teleconference (6/24/10) and another teleconference (9/13/10) to discuss the review of EPA's Toxicological Review of Trichloroethylene (External Review Draft). [Federal Register Jun 2, 2010, Federal Register Jul 27, 2010]
15- Dec 2010	SAB hosted a public meeting of the SAB Trichloroethylene (TCE) Review Panel: by two teleconferences held on 12/15-16/10 to review EPA's Toxicological Review of Trichloroethylene (External Review Draft). [Federal Register Nov 24, 2010]
16- Jan 2011	SAB released the final report, Review of EPA's Draft Assessment entitled "Toxicological Review of Trichloroethylene. (PDF, 68 pp., 407,129 bytes), EPA-SAB-11-002

Additional Information

Comments on the assessment may be submitted and reviewed using the e-Government Regulations.gov Web site. From the site, select Environmental Protection Agency and the key word EPA- HQ-ORD-2009-0791 (for the docket ID).

Instructions for accessing supplementary files to Appendices A, F, and G.
(1) Download "Appendix_linked_files.zip" file.
(2) "Extract" files using Microsoft Windows or equivalent decompression software, creating a folder named "Appendix.linked.files"
(3) Move the folder "Appendix.linked.files" to the same directory where the PDF file for Appendix A, F, or G is located.
(4) Open the PDF file for Appendix A, F, or G using Adobe Acrobat Reader. To open the supplementary files, click on the appropriate links.

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.

• Toxicological Review of Trichloroethylene: In Support of Summary Information on the Integrated Risk Information System (IRIS) (PDF)  (1109  pp, 7.0 MB, about PDF)
• Toxicological Review of Trichloroethylene: Appendices (all) (PDF)  (1221  pp, 8.6 MB, about PDF)
• Charge to External Peer Reviewers (PDF)  (5  pp, 149.4 KB, about PDF)
• 1. Tox Review of trichloroethylene: Front Matter (PDF)  (44  pp, 268.6 KB, about PDF)
• 2. Tox Review of trichloroethylene: Chapter 1. Introduction (PDF)  (2  pp, 128.9 KB, about PDF)
• 3. Tox Review of trichloroethylene: Chapter 2. Exposure Characterization (PDF)  (25  pp, 430.7 KB, about PDF)
• 4. Tox Review of trichloroethylene: Chapter 3. Toxicokinetics (PDF)  (139  pp, 1.3 MB, about PDF)
• 5a. Tox Review of trichloroethylene: Chapter 4. Hazard Characterization (PDF)  (330  pp, 2.3 MB, about PDF)
• 5b. Tox Review of trichloroethylene: Chapter 4. Hazard Characterization (Continued) (PDF)  (291  pp, 2.5 MB, about PDF)
• 6. Tox Review of trichloroethylene: Chapter 5. Dose-Response Assessment (PDF)  (153  pp, 1.7 MB, about PDF)
• 7. Tox Review of trichloroethylene: Chapter 6. Major Conclusions in the Characterization of Hazard and Dose Response (PDF)  (42  pp, 390.6 KB, about PDF)
• 8. Tox Review of trichloroethylene: References (PDF)  (83  pp, 589.8 KB, about PDF)
• 9. Appendix A: PBPK Modeling of TCE and Metabolites - Detailed Methods and Results (PDF)  (116  pp, 1.4 MB, about PDF)
• 10. Appendix B: Systematic Review of Epidemiologic Studies on Cancer and Trichloroethylene (TCE) Exposure (PDF)  (365  pp, 2.0 MB, about PDF)
• 11. Appendix C: Meta-Analysis of Cancer Results from Epidemiological Studies (PDF)  (68  pp, 648.4 KB, about PDF)
• 12. Appendix D: Neurological Effects of Trichloroethylene (PDF)  (133  pp, 975.6 KB, about PDF)
• 13. Appendix E: Analysis of Liver and Coexposure Issues for the TCE Toxicological Review (PDF)  (445  pp, 2.1 MB, about PDF)
• 14. Appendix F: TCE Noncancer Dose-Response Analyses (PDF)  (45  pp, 669.9 KB, about PDF)
• 15. Appendix G: TCE Cancer Dose-Response Analyses with Rodent Cancer Bioassay Data (PDF)  (43  pp, 1.3 MB, about PDF)
• 16. Appendix H: Lifetable Analysis and Weighted Linear Regression based on Results from Charbotel et al. (2006) (PDF)  (6  pp, 245.1 KB, about PDF)
• 17. Appendix Linked Files (zip, 130 MB) (ZIP)  (0 bytes, about ZIP)
• SAB Trichloroethylene (TCE) Review Panel Web Site
• Final SAB Review of EPA's Draft Assessment entitled "Toxicological Review of Trichloroethylene" EPA-SAB-11-002
• TCE Response to Comments (PDF)  (NA  pp, 342.8 KB, about PDF)

Related Link(s)

• Review of EPA’s Draft Assessment entitled "Toxicological Review of Trichloroethylene" (October 2009) (11/23/10 Draft)
• Draft Review Report (August 25, 2010) of EPA’s Draft Assessment entitled "Toxicological Review of Trichloroethylene" (October 2009)
• Preliminary Draft Comments from subgroups of the SAB Trichloroethylene Review Panel (June 17, 2010)