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

Federal Register Notices
Contact
Samantha J. Jones
by phone at:   703-347-8580
by email at:  jones.samantha@epa.gov

Notice

EPA's Science Advisory Board (SAB) Staff Office has announced two meetings for the SAB Chemical Assessment Advisory Committee (CAAC), augmented for the review of the draft IRIS assessment of ethylene oxide (CAAC-Ethylene oxide panel). The first meeting is a public teleconference scheduled for September 30, 2014. The second is a face-to face panel meeting scheduled for November 18-20, 2014 in Arlington, VA. Additional information about participation in the external peer review meetings, including how to provide comments to the SAB, is available on the SAB website and via the Federal Register.

EPA is seeking 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.

Downloads/Related 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.

Related Link(s)

Public Comments

Comments on the draft assessment have been submitted and can be 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).

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.

In August 2014, EPA submitted a revised draft IRIS assessment of ethylene oxide (Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide) to the agency’s SAB and posted this draft on the IRIS website. EPA had previously released a draft of the assessment for public comment, held a public meeting about the draft, and then revised it based on the comments received. The SAB CAAC-Ethylene oxide panel will review this draft assessment. Details about the meeting dates and times are available via the August 11, 2014 Federal Register Notice. The SAB provided information on how the public can participate in the external peer review meetings, as well as instructions about how to provide comments to the SAB in the notice. Additional information on the SAB review of ethylene oxide is on the SAB website.

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’s SAB announced a request for nominations for experts to augment the SAB Chemical Assessment Advisory Committee (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]
Dec 2013EPA hosted an IRIS public science meeting to discuss the draft assessment released for public comment.
Jul 2014EPA’s SAB announced the formation of the CAAC panel augmented for the ethylene oxide review.
Aug 2014EPA submitted the draft assessment (revised in response to public comments) to the SAB for external peer review (step 4c of the IRIS process). [Federal Register Notice Aug 11, 2014]

Next Steps

EPA’s SAB will host two meetings for the SAB CAAC, augmented for the review of the draft IRIS assessment of ethylene oxide (CAAC-Ethylene oxide panel). The first meeting is a public teleconference scheduled for September 30, 2014. The second is a face-to face panel meeting scheduled for November 18-20, 2014 in Arlington, VA. Information on the peer review can be found at the SAB web site or in the Federal Register Notice. 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.

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-14/194A, 2014.

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