EPA Expands TRI Reporting Requirements for Ethylene Oxide and Ethylene Glycol by Requiring Reporting for 29 Sterilization Facilities

WASHINGTON (Dec. 27 2021) Today, the U.S. Environmental Protection Agency (EPA) is taking action to expand the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide (EtO) releases.

Under the Emergency Planning and Community Right-to-Know Act (EPCRA), the EPA Administrator has the discretionary authority to extend TRI reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of releases of the chemical at the facility, or other factors the Administrator deems appropriate.

“For too long, many communities in this country, particularly those with environmental justice concerns, have been at risk of exposure to EtO without even knowing it,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “This determination will require companies that use the largest amounts of EtO in this industry sector to report to the TRI about their releases of this chemical and shed some light on potential exposures from this use. This will help inform EPA’s future actions and empower communities to act at the local level.”

Exposure to EtO can cause cancer in humans and damage DNA. Other effects of EtO exposure include eye, skin, nose, throat, and lung irritation as well as harm to the brain and nervous system (causing effects such as headaches, memory loss, numbness). Workers in facilities that use EtO and people in communities—including historically underserved communities—located adjacent to these facilities have the highest chance of being exposed to EtO. Additionally, because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by EtO.

EtO and ethylene glycol have been on the TRI toxic chemical list since its inception in 1987, but not all facilities that use these chemicals have been subject to TRI reporting requirements.  In October 2021, EPA sent letters to 31 facilities providing notice that EPA was considering exercising its discretionary authority. After corresponding with many of the facilities, EPA has decided to issue a determination extending TRI reporting requirements to 29 of the 31 facilities for EtO and to 16 of the 31 facilities for ethylene glycol. Ethylene glycol is produced using ethylene oxide; thus, these chemicals may co-occur at facilities. will also directly notify the facilities of this determination.

EPA believes these 29 contract sterilization facilities, which do not currently report to TRI, use the highest amounts of EtO in the contract sterilization sector. The facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for EtO. EPA also considered additional factors such as the facilities’ proximity to a population center (e.g., the number of people, including children under the age of five living near the facilities), their history of releases of ethylene oxide and ethylene glycol (e.g., past receipt of TRI reporting forms on ethylene oxide and ethylene glycol from these facilities), and other factors the Administrator deemed appropriate (e.g., proximity of the facilities to nearby schools and communities, especially those with potential environmental justice concerns, and concerns for facility workers).

EPA elected not to extend TRI reporting requirements to two of the 31 facilities initially contacted. One of the facilities conveyed to EPA that they had sold the establishment they previously used for sterilization and no longer perform sterilization work at that facility. Another facility informed EPA that their facility uses EtO in quantities far below the amount that would trigger TRI reporting in a year due to their sterilization technology and scale of operations.

The determination to extend TRI reporting requirements to these 29 facilities is part of an ongoing effort to increase publicly available information on EtO releases and other waste management activities. EPA will continue to monitor additional contract sterilization facilities using EtO and, if appropriate, consider using this discretionary authority to extend TRI reporting requirements to those facilities as well.

Beginning in January 2022, these 29 facilities should start tracking their activities involving EtO (and ethylene glycol, if applicable), releases and other waste management quantities as required by EPCRA, similar to any other facility subject to TRI reporting requirements. If reporting thresholds are met, the facilities must submit TRI data beginning in 2023.  

To learn more about the determination visit: https://www.epa.gov/toxics-release-inventory-tri-program/discretionary-authority-extend-tri-reporting-requirements.

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