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Environmental Assessment

Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised External Review Draft)

Notice

In July 2013, EPA announced the release of the draft IRIS Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised External Review Draft) for a 45-day public review and comment period. Following the public comment period it will undergo a public peer review meeting with the EPA Science Advisory Board (SAB). SAB will announce the dates and details for this meeting on their web site. [Federal Register Notice July 23, 2013]

Update: In August 2013, EPA sent out a request for nominations of experts panelist to augment the Chemical Assessment Advisory Committee (CAAC) for the review of the EPA’s draft IRIS Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised External Review Draft). Information on submitting nominations, meeting dates, and additional details were given on the SAB Ethylene Oxide Activity Web site (see "related links"). In addition, EPA extended the public comment period to October 11, 2013. [Federal Register Notice Aug 28, 2013]

Report Information

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. Please refer to IRISTrack – Ethylene Oxide for the latest schedule updates.

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Jennifer Jinot
  • by phone at:   703-347-8597
  • by email at:  jinot.jennifer@epa.gov

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

Apr 1984EPA released the Health Assessment Document for Ethylene Oxide (External Review Draft)(EPA-600/8-84/009A).
Jun 1985EPA published the Health Assessment Document for Ethylene Oxide (Final) (EPA-600/8-84/009F).
Dec 1998EPA begins work on new assessment of carcinogenicity of EtO.
Mar 2006Completion of internal EPA review of draft assessment of carcinogenicity of EtO.
Aug 2006Completion of external Federal agencies review of EPA’s draft assessment of carcinogenicity of EtO.
Sep 2006EPA released the draft assessment for a 30-day public comment period. [Federal Register Notice September 22, 2006]
Oct 2006A 30-day extension is given for the public comment period. [Federal Register Notice October 12, 2006]
Jan 2007Peer review meeting of the Science Advisory Board (SAB) (public meeting).
Dec 2007EPA’s SAB issued a final report on the review of the draft assessment of EtO.
Jul 2011EPA initiated Final Agency and Interagency Science Discussion (step 6 of the IRIS process) of the draft assessment of EtO.
Jun 2012EPA conducted further Agency review of a revised draft.
Jul 2013EPA 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 2013EPA announced an extension of the public comment period from September 5 to October 11, 2013. [Federal Register Notice Aug 28, 2013]
Aug 2013EPA 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]

Next Steps

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.

Additional Information

Comments on the draft 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-2006-0756 (for the docket ID).

Citation

U.S. EPA. Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-13/128, 2013.

Downloads

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.

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