In our last report, we discussed the EPA’s increased activity with respect to Ethylene Oxide (EtO), which it considers a human carcinogen. As we discuss below, however, on the local level, many of the states are also legislating EtO emissions. The below are not the only states that have turned their attention to EtO, but they provide a good snapshot of local initiatives to regulate emissions.
In Massachusetts, although only one facility uses ethylene oxide in large quantities to sterilize disposable medical equipment, the Attorney General in 2020 joined the Attorney Generals of ten other states urging the EPA to impose stricter regulations over commercial operations that emit EtO. In addition, earlier this year, House Bill 921 was filed, which proposes to regulate hydraulic fracking and includes language that no person shall use toxic chemicals, including ethylene oxide, in connection with the extraction of natural gases.
Ethylene oxide also has captured the attention of the Illinois state legislature, which has passed legislation designed to restrict EO emissions. In 2019, Illinois passed two laws regulating ethylene oxide. Senate Bill 1852, passed on June 21, 2019, prohibits ethylene oxide sterilization facilities from operating in Illinois unless they capture 100 percent of all ethylene oxide emissions within the facility and reduce ethylene oxide emissions to 0.2 parts per million. Senate Bill 1854, also passed on June 21, 2019, applies emission limits on non-sterilization facilities that emit ethylene oxide, requiring those facilities to obtain a permit from the Illinois Environmental Protection Agency (IEPA), which must include a site-specific cap on the facility’s ethylene oxide emissions. It also requires the IEPA to conduct unannounced inspections and air testing at least once annually.
In February 2021, additional EtO legislation was proposed in Illinois. House Bill 2385 would require the Environmental Protection Agency to conduct continuous fence line air monitoring, using air canisters, of ethylene oxide at any facility emitting ethylene oxide in a densely populated area. It provides that the Agency shall publicly post the results of the monitoring on its website within 30 days after each sample is taken. It also requires the Agency to establish fence line monitoring of ethylene oxide limits at 0.02 micrograms per cubic meter, and goes on to require that if fence line monitoring shows EtO levels higher than .02 micrograms per cubic meter for any period of five or more days during a 30 day period, the emitting facility is subject to civil penalty.
Legislation filed on November 16, 2020 would open up manufacturers in Georgia that use ethylene oxide to additional restrictions. House Bill 3 would require facilities seeking a permit to release more than 50 pounds of ethylene oxide annually to let the Georgia Environmental Protection Division (EPD) install electronic devices to continuously monitor those emissions and release the findings at least twice a year.
The need for tighter regulation of the chemical became apparent in 2019 after public concerns were raised over unreported releases at a Sterigenics plant in Smyrna and a facility in Covington operated by BD Bard.
In 2020, Georgia passed a bill introduced in the state Senate requiring manufacturers that use ethylene oxide to report any waste spills or gas releases to the EPD within 24 hours. The director of the EPD then must post the information on the agency’s website.
“We made progress during the previous legislative session to report ethylene oxide spills through Senate Bill 426,” said Rep. Erick Allen, D-Smyrna, sponsor of House Bill 3. “I hope that the state legislature will act swiftly to help monitor emitting patterns and help prevent the risks that threaten our communities.” Allen’s bill also would require manufacturers releasing ethylene oxide to submit a detailed ambient air plan to the EPD by January 2022.
Senate Bill180, introduced in February 2021, proposes that as a condition of a permit for operations that include the emission of ethylene oxide, any spill or release of ethylene oxide, regardless of the amount, shall be reported to the division in writing within 24 hours of discovering such spill or release. The bill has been referred to the Senate Natural Resources and the Environment Committee.
On the federal level the EPA is promulgating increasingly stricter regulations concerning both the manufacture and use of EtO. Presumably, this will also serve to give rise to increased private tort litigation. In April of this year, the EPA announced that it would begin requiring companies to report more releases of chemicals, including EtO. It is also important to note, as detailed above, that the states are increasingly proposing or enacting legislation concerning EtO emissions. With both state and federal agencies involved, companies that either emit or utilize EtO would be well advised to understand the specifics of existing and proposed state and national legislation so as not to run afoul of same. To minimize the risk of being sued by private parties or by regulatory agencies, retaining an expert to review whether a facility is emitting EtO unknowingly (or in excess of allowable regulatory levels) is recommended. We cannot stress enough that companies must be proactive with respect to potential litigation, whether private via the tort system or public via state and federal regulatory agencies.
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.