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EPA Grants ACC’s Petition for Reconsideration on Ethylene Oxide Rule

WASHINGTON (June 22, 2021) – The American Chemistry Council (ACC) released the following statement, applauding the decision by the Environmental Protection Agency (EPA) to grant ACC’s petition for reconsideration related to the use of the flawed IRIS value for ethylene oxide in the final MON rule:

“We appreciate the EPA’s willingness to consider the latest science on this issue. In the final MON rule, the EPA had not considered the alternative, independent assessment conducted by TCEQ because it had not been peer reviewed. That assessment has now been peer reviewed and found the risk value of ethylene oxide to be 4,000 times lower than the IRIS program concluded. We look forward to working with EPA through this process to achieve strong, science based regulations that are protective of human health and the environment.”

Background:

Ethylene oxide is a versatile and valuable compound that’s used to help make countless everyday products. It is used to make household cleaners and personal care items, create fabrics, and manufacture raw materials into more useful forms. A small but important use of ethylene oxide is the sterilization of medical equipment, including the sterilization of personal protective equipment used by doctors and hospitals across the country during the response to the COVID-19 pandemic.

In 2016, the EPA Integrated Risk Information System (IRIS) program released an updated cancer value based on modeling. We believe this value is significantly flawed. For example, the proposed cancer risk level published in the IRIS report is 19,000 times lower than naturally-occurring levels of ethylene oxide found in the human body.

A number of independent reviews also question the IRIS program and its findings. The National Academy of Sciences found inconsistencies in the methodology that the IRIS program used to evaluate other chemicals. Two EPA Science Advisory Boards also outlined additional key issues with the EO IRIS assessment. And the Texas Commission on Environmental Quality (TCEQ) has said that EPA’s model “over-estimates the cancer potency of ethylene oxide.”

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