EPA Announces Final Rule to Slash Toxic Emissions of Ethylene Oxide and Reduce Cancer Risk

March 18, 2024
The EPA announced a rule that will reduce lifetime cancer risks for people living near commercial sterilization facilities across the country. The final amendments to the air toxics standards for ethylene oxide commercial sterilization facilities put in place the strongest measures in U.S. history to reduce emissions of EtO, one of the most potent cancer-causing chemicals. Through the installation of proven and achievable air pollution controls, commercial sterilizers will reduce emissions by more than 90%.
This final rule advances President Biden’s commitment to ending cancer as we know it as part of the Cancer Moonshot, while also advancing the Biden-Harris Administration’s commitment to environmental justice by protecting communities that are most exposed to toxic chemicals. EtO can be particularly harmful to children and communities that are already overburdened by pollution.
In finalizing this rule, EPA considered the latest data and science, while taking into account the importance of a safe and reliable supply of medical sterilization devices for patients and hospitals. EPA worked closely with partners across the Biden-Harris Administration, including at the Department of Health and Human Services, to develop a final rule that centers on public health. This final rule provides sufficient time and flexibility for facilities to come into compliance, simultaneously affording strong public health protection for nearby communities while minimizing any potential impacts to the medical device supply chain.
“This final rule to sharply cut toxic emissions of ethylene oxide responds to the ambition set forth by President Biden’s Cancer Moonshot,” said EPA Administrator Michael S. Regan. “We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution – including the health of children, who are particularly vulnerable to carcinogens early in life. We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
“For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution,” said Xavier Becerra, United States Secretary of Health and Human Services. “We will continue to work together with EPA to achieve our shared goals of lowering EtO exposure while also mitigating potential risks of medical device shortages.”
In developing the final rule, EPA conducted extensive outreach to communities and stakeholders to ensure meaningful and extensive participation during the public comment period. EPA conducted public hearings, national webinars, and public meetings hosted by regional EPA offices. The considerable feedback received from the three days of public hearings, as well as the more than 40,000 comments submitted to the rulemaking docket, both informed the final rule and demonstrated the strong need to issue these vital health protections. Based on this input, EPA improved the risk assessment and strengthened the standards to ensure risk reductions for surrounding communities.
The final rule will address emissions at nearly 90 commercial sterilization facilities that are owned and operated by approximately 50 companies. Based on extensive input and review, EPA is finalizing the following amendments to the National Emission Standards for Hazardous Air Pollutants that:
  • Establish standards for currently unregulated emissions, such as building leaks (“room air emissions”) and chamber exhaust vents, to reduce cancer risk and account for technological developments in pollution control.
  • Strengthen standards that are on the books for sources such as sterilization chamber vents and aeration room vents.
  • Require continuous emissions monitoring and quarterly reporting for most commercial sterilizers that will provide communities, states, Tribes, and local governments, and EPA with data to ensure EtO emissions are not entering the outdoor air.
  • Ensure that sterilizers are subject to emission standards during periods of startup, shutdown, and malfunction so there is continuous clean air protection.
  • Other clarifying items including electronic reporting and technical revisions.
The Biden-Harris Administration believes securing our supply of medical devices is essential. To prevent unintended consequences and ensure orderly implementation, the Clean Air Act has long provided backstop authority allowing the President to provide a two-year compliance exemption to assist a facility with achieving compliance with National Emission Standards for Hazardous Air Pollutants in carefully delimited special circumstances — if the technology to implement the standard is not available and it is in the national security interest to provide additional time to comply. EPA has confirmed that the President is prepared to exercise this authority, if necessary to protect the medical supply chain and a commercial sterilizer is working in good faith to come into compliance with the rule.
This final rule for commercial sterilizers is one of a series of coordinated actions that EPA is taking to reduce exposure to EtO. Under the Federal Insecticide, Fungicide, and Rodenticide Act, EPA’s Office of Pesticide Programs is also working on a comprehensive set of new mitigation measures for EtO to reduce exposure for workers who use EtO to sterilize products. EPA has been working to support alignment of this Clean Air Act rule with the action being taken under FIFRA.
EPA is also working to strengthen standards to reduce EtO and other toxic pollutants from chemical plants. Other actions to address EtO emissions and advance EtO research include:
  • Investigating additional sources of EtO (e.g., stand-alone warehouses) and opportunities for emissions controls.
  • Enforcing existing regulations as appropriate.
  • Conducting research to better understand and measure EtO.
Hazardous Waste Facility Settles Enforcement Case with EPA
Systech Environmental Corporation will pay $98,513 in civil penalties to resolve alleged violations of the federal Resource Conservation and Recovery Act and the terms of its Hazardous Waste Management Facility Permit.
According to the EPA, the company operates as a hazardous waste treatment, storage, and disposal facility in Fredonia, Kansas. EPA inspections in October 2022 revealed the following alleged violations:
  • Failure to properly store hazardous waste.
  • Failure to fully close hazardous waste containers.
  • Tanks that were emitting hazardous pollutants exceeding permit limits.
  • Failure to mark containers as hazardous waste.
“Facilities that handle hazardous waste have a heightened obligation to protect workers and the surrounding community from releases,” said David Cozad, director of EPA Region 7’s Enforcement and Compliance Assurance Division. “This penalty action demonstrates EPA’s commitment to protecting communities and leveling the playing field for companies that comply with the law.”
EPA says that since the inspections, the company has corrected the violations.
The Resource Conservation and Recovery Act (RCRA) creates the framework for the proper management of hazardous and non-hazardous solid waste.
Need help determining if you need hazardous waste training? View our YouTube video here: Who needs hazardous waste training?
EPA Finalizes Standards to Limit Air Toxic Pollution at Gasoline Distribution Facilities
The EPA is announcing its action to reduce toxic air pollution from gasoline distribution facilities, including storage tanks, loading operations and equipment leaks. These rules, which exclude gas stations, are expected to reduce emissions of air toxics, including benzene, hexane, toluene, and xylene, by 2,220 tons per year, and emissions of volatile organic compounds by 45,400 tons per year.
“These rules will protect public health for communities near gas distribution facilities, which are disproportionately communities of color and low-income communities,” said Joseph Goffman, Assistant Administrator for EPA’s Office of Air and Radiation. “By helping to reduce exposures to toxic air emissions, these actions will help communities breathe cleaner air, improving lives in communities already overburdened by pollution.”
People exposed to toxic air pollutants may have an increased chance of getting cancer or experiencing other serious health effects within their lifetimes. These health effects can include damage to the immune system, as well as neurological, reproductive, developmental, respiratory and other health problems. Volatile organic compounds (VOCs) can have short- and long-term adverse health effects, and evaporated VOCs can react in the atmosphere to produce secondary pollutants, including ozone and secondary organic aerosol, a contributor to fine particles, or soot.
The air toxics emitted by Gasoline Distribution sources are benzene, hexane, toluene, xylene, ethylbenzene, 2,2,4-trimethylpentane, cumene and napthalene.
For the final rule, EPA has considered input received during the public comment period and made several adjustments to enhance environmental protection while ensuring no significant impacts on small businesses or gas prices. 
This action will require gasoline distribution facilities to adopt cost-effective practices and control technologies to reduce emissions from storage tanks, loading operations, and equipment leaks. EPA is also finalizing New Source Performance Standards for Bulk Gasoline Terminals to reflect the best system of emissions reduction for loading operations and equipment leaks. Because the rules will reduce air emissions, such as leaks at these facilities, EPA projects that some of these reductions will result in annualized cost savings—a win-win for companies, consumers, and environmental justice communities. The final action includes revisions related to emissions during periods of startup, shutdown, and malfunction; monitoring and operating provisions for control devices; and electronic reporting.  
Red Barn Truck Wash Cited After Three Workers Were Injured from Exposure to Harmful Gases
Federal investigators determined a truck washing company failed to protect workers from hydrogen sulfide gas as they entered over-the-road tanker trailers to clean them out, causing one worker's fatal injuries and hospitalizing two co-workers.
OSHA responded to a report of the Sept. 1, 2023, incident and found Red Barn Truck Wash & Service Center LLC failed to evaluate the tanker trailers for hazardous conditions – including testing the atmosphere – and did not train workers on potential hazards before letting them enter the confined spaces, both violations of OSHA regulations.
"Wherever organic matter such as crops and other materials are stored, hydrogen sulfide may be present as a natural byproduct. Workers must never enter storage facilities, tankers or other confined spaces without doing atmospheric testing and wearing protective equipment such as respirators capable of preventing inhalation of this colorless and toxic gas," explained OSHA Area Director Todd Underwood in Wichita, Kansas. "Red Barn Truck Wash & Service Center must implement procedures and training immediately to protect its employees from these preventable injuries."
Inspectors found multiple violations of OSHA’s confined space regulations and noted Red Barn Truck Wash lacked both respiratory and hearing protection programs and exposed workers to fall hazards of up to nine feet while cleaning the trailers.
OSHA cited the company for two willful and 24 serious violations and proposed $171,680 in penalties.
Proper Safeguards Might Have Prevented Fatal Forklift Incident at Logan International Airport
A fatal injury of a forklift operator at Boston’s Logan International Airport may have been prevented if his employer, a Rochester, New York-based maintenance firm, had ensured proper safeguards for operating and maintaining forklifts, an OSHA inspection has found.
An Oxford Airport Technical Services’ employee was attempting to drive a forklift into a building when the vehicle’s forks and mast struck the overhang of the entrance, causing the forklift to tip over. The operator, who was not wearing a seatbelt, fell to the ground, and the tipping vehicle fatally struck him.
OSHA inspectors found that the company failed to ensure the worker wore a seat belt while operating the forklift, exposing him to rollover and crushing hazards. The agency also determined the following:
  • The forklift’s forks and mast were not raised only as far as necessary to clear the road surface.
  • All forklift operators were not properly trained and certified.
  • A damaged forklift was not examined before being placed in service.
  • A damaged forklift was not taken out of service.
These violations resulted in OSHA issuing four serious citations with $46,096 in proposed penalties.
“Every workplace fatality is tragic, especially when there are well-known safety measures that could have prevented the loss of person’s life,” said OSHA Area Director James Mulligan in Braintree, Massachusetts. “In this case, the employer failed to train and certify their forklift operators on critical safety requirements. It’s simply inexcusable.”
Oxford Airport Technical Services has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
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