Ethylene oxide

Overview

EPA conducted a peer review and public comment of the scientific basis supporting the human health hazard and dose-response assessment of ethylene oxide (cancer) that when finalized will appear on the Integrated Risk Information System (IRIS) database.

Background

Ethylene Oxide 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).
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 report and announced a 30-day public comment period in a September 22 Federal Register Notice.
Oct 2006	EPA announced an extension from 30-day to 60-day public comment period in an October 12, 2006 Federal Register Notice.
Oct 2006	There was a correction made to the document, as described in the October 20, 2006 Federal Register Notice.
Nov 2006	EPA released the NCEA EtO Peer Review Charges and Memo to the SAB for their review (see downloads).

Status

Following review by the Science Advisory Board and consideration of public comments received, the Agency will finalize the EtO carcinogenicity document and place it in EPA’s IRIS data base.

Additional Information

The release of this draft document is solely for the purpose of seeking public comment and for review by the EPA Science Advisory Board (SAB) via a meeting to be held later in 2006. The time and place of the SAB meeting will be announced in a separate Federal Register notice. This document has not been formally disseminated by EPA and does not represent, and should not be construed to represent, any Agency policy or determination.

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.

• Evaluation of the Carcinogenicity of Ethylene Oxide (PDF)  (164  pp, 3.1 MB, about PDF)
• NCEA Proposed Draft Charge to the External Peer Review (PDF)  (5  pp, 204.1 KB, about PDF)
• MEMO TO SAB REQUESTING THE DOCUMENT REVIEW (PDF)  (2  pp, 28.3 KB, about PDF)
• SAB Review of the IRIS Assessment for the Ethylene Oxide Carcinogenicity Assessment Activities Page
• Science Advisory Board Ethylene Oxide (EtO) Review Panel Draft Report -- August 30 2007

If you have a disability and the format of any material on our web pages interferes with your ability to access the information, please reach out to us using the Contact Us about IRIS form for assistance. To enable us to respond in a manner most helpful to you, please indicate the nature of the accessibility problem, the web address of the requested material, your preferred format in which you want to receive the material (electronic format (ASCII, etc.), standard print, large print, etc.), and your contact information.

Document Related Link(s)

• Review of Office of Research and Development 's (ORD) Draft Assessment Entitled, "Evaluation of the Carcinogenicity of Ethylene Oxide" (Final Report)
• Ethylene Oxide (EtO) Draft SAB Report for Review at the May 29 2007 Public Teleconference (May 15 2007 Draft)
• ATSDR: TOXICOLOGICAL PROFILE FOR ETHYLENE OXIDE (PDF)  (122  pp, 1000 bytes, about PDF)

Federal Register Notices

• FR NOTICE: OCTOBER 20, 2006
• FR NOTICE: OCTOBER 12, 2006
• FR NOTICE: SEPTEMBER 22, 2006
• FR NOTICE: MARCH 1, 2006