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

The U.S. Environmental Protection Agency (EPA) announced on December 27, 2021, that it is expanding the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide releases. EPA states that 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.” According to EPA, exposure to ethylene oxide can cause cancer in humans and damage DNA. Other effects include eye, skin, nose, throat, and lung irritation, as well as harm to the brain and nervous system. Workers in facilities that use ethylene oxide and people in communities located adjacent to these facilities, including historically underserved communities, have the highest chance of being exposed to ethylene oxide. EPA notes that because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by ethylene oxide.

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 issued a determination extending TRI reporting requirements to 29 of the 31 facilities for ethylene oxide and to 16 of the 31 facilities for ethylene glycol. According to EPA, because ethylene glycol is produced using ethylene oxide, these chemicals may co-occur at facilities. EPA states that it believes these 29 contract sterilization facilities, which do not currently report to TRI, use the highest amounts of ethylene oxide in the contract sterilization sector. The facilities are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for ethylene oxide. EPA notes that it 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 did not to extend TRI reporting requirements to two of the 31 facilities initially contacted. According to EPA, 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 ethylene oxide in quantities far below the amount that would trigger TRI reporting in a year due to their sterilization technology and scale of operations.

Beginning in January 2022, these 29 facilities should start tracking their activities involving ethylene oxide (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.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 362
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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