US EPA

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.

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.

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.

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.