Ethylene oxide

Overview

EPA is initiating a public comment period prior to peer review of the scientific basis supporting the human health hazard and dose-response assessment of ethylene oxide (cancer) that will appear in the Integrated Risk Information System (IRIS) database.

Background

Ethylene Oxide (EtO) is a gas at room temperature used in chemical manufacturing and as a sterilizing agent for medical equipment and a fumigating agent for spices. Human exposure occurs in occupations involving contact with the gas in production facilities and hospitals that sterilize medical equipment. EtO can also be inhaled by residents living near production or sterilizing/fumigating facilities.

History/Chronology

Date	Description
Apr 1984	EPA released the Health Assessment Document for Ethylene Oxide (External Review Draft)(EPA-600/8-84/009A).
Jun 1985	EPA published the Health Assessment Document for Ethylene Oxide (Final) (EPA-600/8-84/009F).
Dec 1998	EPA begins work on new assessment of carcinogenicity of EtO.
Mar 2006	Completion of internal EPA review of draft assessment of carcinogenicity of EtO.
Aug 2006	Completion of external Federal agencies review of EPA's draft assessment of carcinogenicity of EtO.
Sep 2006	EPA released the draft assessment for a 30-day public comment period. [Federal Register Notice September 22, 2006]
Oct 2006	A 30-day extension is given for the public comment period. [Federal Register Notice October 12, 2006]
Jan 2007	Peer review meeting of the Science Advisory Board (SAB) (public meeting).
Dec 2007	EPA's SAB issued a final report on the review of the draft assessment of EtO.
Jul 2011	EPA initiated Final Agency and Interagency Science Discussion (step 6 of the IRIS process) of the draft assessment of EtO.
Jun 2012	EPA conducted further Agency review of a revised draft.
Jul 2013	EPA revised the draft assessment and released for additional public review and comment (step 4 of the IRIS process). The interagency science discussion draft of the assessment and related comments are also available. [Federal Register Notice Jul 23, 2013]
Aug 2013	EPA announced an extension of the public comment period from September 5 to October 11, 2013. [Federal Register Notice Aug 28, 2013]
Aug 2013	EPA announced a request for nominations for experts to augment the SAB CAAC to form a panel for the review of the EPA's draft IRIS Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised External Review Draft). [Federal Register Notice Aug 28, 2013]

Status

EPA’s SAB will be taking nominations and forming a peer review panel, and announcing the final panel and a public comment period for the revised external review draft IRIS Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide. Information on the peer review can be found at the SAB web site at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/Eto%20Inhalation%20Carcinogenicity?OpenDocument. The SAB will announce the dates and details for their peer review meeting on their web site. Following external peer review, the assessment will be revised taking into consideration the comments received. It will then undergo a final internal review by EPA, and other federal agencies and the Executive Office of the President. After completing this review it will be posted to the IRIS database.

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.

• Revised External Review Draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Main Report) - July 2013 (PDF)  (174  pp, 1.7 MB, about PDF)
• Revised External Review Draft Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Appendices) - July 2013 (PDF)  (263  pp, 2.7 MB, about PDF)
• Charge to External Reviewers (PDF)  (5  pp, 118.2 KB, about PDF)
• IRIS December Bimonthly Meeting -- EtO Presentations

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Document Related Link(s)

• SAB Project Page for Ethylene Oxide (2013)
• Evaluation of the Carcinogenicity of Ethylene Oxide (2006 External Review Draft)
• Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (2011 Interagency Science Discussion Draft)

Federal Register Notices

• FR Notice: Aug 28, 2013
• FR Notice: Jul 23, 2013

Docket

Comments on the assessment may be submitted and reviewed using the Docket ID EPA-HQ-ORD-2006-0756