As previously discussed in our recent reports, the Biden administration and the EPA have been emphasizing environmental justice, which includes a focus on Ethylene Oxide (EtO), an industrial solvent widely used as a sterilizing agent for medical equipment that cannot otherwise be sterilized by heat/steam. EtO may also be used as a component for producing other chemicals, including glycol and polyglycol ethers, emulsifiers, detergents, and solvents. Allegations that exposure to ethylene oxide emissions may increase the risk of certain cancers will increasingly subject certain companies and industries to governmental regulation and/or private tort actions. In particular, the chemical and healthcare industries must take notice of the increased attention paid to EtO emissions.

Ethylene Oxide Emissions – Recent EPA Action

Ending the year with a bang, on December 27, 2021, the EPA expanded its Toxics Release Inventory (TRI) reporting requirements to include 29 contract sterilization facilities that were not currently obligated to report on EtO releases.

In a December 27^th bulletin, the EPA noted that under the Emergency Planning and Community Right-to-Know Act (EPCRA), it had 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 appropriate factors.

In its bulletin, EPA’s Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff is quoted as stating “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. 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.”

The 29 contract sterilization facilities that do not currently report to TRI but which will now be required to do so are as follows (note that California has the most facilities at issue with five, followed by Texas with four):

1. Parter Medical Products Inc, Carson, CA
2. Sterigenics US, Inc., Vernon, CA
3. Sterigenics US, LLC, Ontario, CA
4. Steris Isomex Services Inc, San Diego, CA
5. Steris, Inc., Temecula, CA
6. International Sterilization Laboratory, Groveland, FL
7. Sterigenics U.S. LLC, Atlanta, GA
8. Medline Industries, Waukegan, IL
9. Isomedix Operation, Inc., Northborough, MA
10. Professional Contract Sterilization, Inc., Taunton, MA
11. Fuchs North America, Hampstead, MD
12. Trinity Sterile, Inc., Salisbury, MD
13. STERIS Inc., Coon Rapids, MN
14. Sterigenics US, LLC, Charlotte, NC
15. Andersen Products, Inc., Haw River, NC
16. ETO Sterilization-Plant #2, Linden, NJ
17. Steris Isomedix Services Inc, South Plainfield, NJ
18. Sterigenics-Santa Teresa, NM, Santa Teresa, NM
19. Long Island Sterilization, Hauppauge, NY
20. Sterigenics US LLC, Queensbury, NY
21. LEMCO Ardmore, Ardmore, OK
22. Boston Scientific Corporation, Coventry, RI
23. STERIS-Isomedix Services, Spartanburg, SC
24. Sterilization Services of Tennessee, Memphis, TN
25. Steritec, Inc., Athens, TX
26. Isomedix Operations, Inc., El Paso, TX
27. Isomedix Operations, Inc., Grand Prairie, TX
28. Sterigenics U.S. LLC, Grand Prairie, TX
29. Sterigenics -Salt Lake City Facility, Salt Lake City, UT

EtO has been on the TRI toxic chemical list since its inception in 1987, but not all facilities that use it have been subject to TRI reporting requirements. In October 2021, the EPA sent letters to 31 facilities providing notice that it was considering exercising its discretionary authority. Today’s announcement by the EPA extends TRI reporting requirements with respect to EtO emissions to the 29 facilities listed above.

The EPA cited as support for extending TRI reporting requirements to the 29 facilities the fact that they use the highest amounts of EtO in the contract sterilization sector and are likely to exceed the 10,000 pounds per year “otherwise used” TRI reporting threshold for EtO. In addition, the EPA also considered additional factors, including these facilities’ proximity to population centers and their history of releases of EtO.

According to the EPA, the decision to now extend TRI reporting requirements to these 29 facilities is a component of an ongoing effort to increase publicly available information on EtO releases (and other waste management activities). EPA also noted that it will continue to monitor additional contract sterilization facilities using EtO and, if appropriate, use its discretionary authority to extend TRI reporting requirements to those facilities as well.

Per the EPA, in 2022 these 29 facilities should begin tracking their EtO 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.

Executive Summary

Under the Biden Administration, the EPA is exercising its clout to increase its regulation of ethylene oxide emissions.  The EPA considers EtO a human carcinogen (although as we will discuss in a later report this is not an opinion universally shared), and, accordingly, is ramping up its efforts to increase Toxics Release Inventory  reporting requirements.  Although the 29 facilities noted in this report are largescale industrial operations, it is not out of the realm of possibility that smaller facilities may also be obligated to report EtO emissions down the road.  Prudence dictates that companies monitor their EtO emissions, and, to the extent possible, reduce them in order to avoid future expanded EPA regulation and/or private tort litigation.

CMBG3 Law LLC has represented clients in environmental and products liability matters for years, and we have predicted several emerging contaminants as financial and litigation risks before they came to fruition, including PFAS, glyphosate, talc and asbestos. We regularly consult with private equity, banking, and investment world firms to identify future risk potentials from portfolios under consideration. For more information about the risks that ethylene oxide may pose to your business, please contact David Goldman.