Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised August 2014 External Review Draft) (SAB Review Draft)

Abstract

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.
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.

Impact/Purpose

EPA seeks external peer review on how the Agency responded to the SAB panel recommendations, the exposure-response modeling of epidemiologic data, including new analyses since the 2007 external peer review, and on the adequacy, transparency, and clarity of the revised draft. The peer review will include an opportunity for the public to address the peer reviewers.

Status

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 August 2014 External Review Draft) (SAB Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-14/194A, 2014.

Date	Description
02- Jun 1985	EPA published the Health Assessment Document for Ethylene Oxide (EPA-600/8-84/009F).
03- Dec 1998	EPA begins work on new assessment of carcinogenicity of EtO.
04- Mar 2006	Completion of internal EPA review of draft assessment of carcinogenicity of EtO.
05- Aug 2006	Completion of external Federal agencies review of EPA's draft assessment of carcinogenicity of EtO.
06- Sep 2006	EPA released the draft assessment for a 30-day public comment period. [Federal Register Notice September 22, 2006]
07- Oct 2006	A 30-day extension is given for the public comment period. [Federal Register Notice October 12, 2006]
10- Jan 2007	Peer review meeting of the Science Advisory Board (SAB) (public meeting).
11- Dec 2007	EPA's SAB issued a final report on the review of the draft assessment of EtO.
12- Jul 2011	EPA initiated Final Agency and Interagency Science Discussion (step 6 of the IRIS process) of the draft assessment of EtO.
13- Jun 2012	EPA conducted further Agency review of a revised draft.
15- 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]
16- Aug 2013	EPA announced an extension of the public comment period from September 5 to October 11, 2013. [Federal Register Notice Aug 28, 2013]
17- Aug 2013	EPA'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]
18- Dec 2013	EPA hosted an IRIS public science meeting to discuss the draft assessment released for public comment.
19- Jul 2014	EPA's SAB announced the formation of the CAAC panel augmented for the ethylene oxide review.
20- Aug 2014	EPA 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]

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.

• Note to Reviewers (August 2014) (PDF)  (3  pp, 41.0 KB, about PDF)
• Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (August 2014) (EPA/635/R-14/194a) (PDF)  (188  pp, 1.4 MB, about PDF)
• Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide - Appendices (August 2014) (EPA/635/R-14/194a) (PDF)  (284  pp, 2.1 MB, about PDF)
• NCEA Draft Charge to the Reviewers (August 2014) (PDF)  (5  pp, 143.6 KB, about PDF)
• SCIENCE ADVISORY BOARD REVIEW OF THE EPA’S EVALUATION OF THE INHALATION CARCINOGENICITY OF ETHYLENE OXIDE (REVISED EXTERNAL REVIEW DRAFT - AUGUST 2014)
• AGENCY RESPONSE

Related Link(s)

• SAB Project Page: IRIS Assessment for Ethylene Oxide (2014) - Evaluation of Inhalation Carcinogenicity
• Formation of the Chemical Assessment Advisory Committee (CAAC) Augmented for the Ethylene Oxide Review (Memo, Jul 11, 2014)
• Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (Revised July 2013 External Review Draft) (Public Comment Draft)

Docket

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