Sterile storage of medical and surgical instruments in the dentist's office. View from above. Closeup shoot.

FDA Finally Recognizes EtO Sterilizing Alternative as the World Becomes a Force Majeure Pile-Up

Perhaps nothing has proven the indispensable value of commercial sterilizers more than the devastating worldwide COVID-19 pandemic. Without the highly effective and efficient commercial sterilizer ethylene oxide (EtO), we would not have been able to rely on lifesaving sterilized medical equipment and supplies – such as cotton swabs for nasal-swab testing, masks, ventilators, and thermometers – to get us through the past four years. Moreover, maintaining basic hospital functionality and everyday healthcare needs outside of the pandemic requires sterile equipment and supplies simply for civilization …

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EPA Offices, Washington DC

Lawsuits Claim EPA’s EtO Rules are Too Little, Too Late

Following the U.S. Environmental Protection Agency’s 2016 finding that ethylene oxide (EtO), a highly effective chemical routinely used to sterilize medical devices and equipment, was significantly more hazardous than previously understood, individuals and shareholders began filing lawsuits against various EtO-using entities throughout the United States with no end in sight. At the end of last month, however, it was the EPA that became the legal target of furious environmental justice and health advocates acting on behalf of the communities the EPA is tasked to …

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EPA Offices, Washington DC

FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused medical providers to spend billions on alternative sterile medical products and even implementing rations in some cases. Complicating the issue is the fact that, typically, only a handful of manufacturers and suppliers distribute these life-saving products, so alternatives can be difficult to procure. Shortages appear to be endangering other …

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American Public Is Thrown Into the EtO Mix with Government and Industry

After a COVID-related dip, ethylene oxide (EtO) cannot seem to stay out of the news these days. Every week there is some EtO-related legal or technological development in the United States. And now the public is being encouraged to shape the oversight of EtO use and manufacture. 

Following a long pause in years-long and intense regulatory focus — a direct result of the pandemic, an emergency requiring exponential use of EtO, a highly efficient sterilizing chemical used on billions of medical devices and hospital supplies …

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United States Environmental Protection Agency

Highly Anticipated Proposed EtO Rules the EPA Just Announced: Were They Worth The Wait?

After years of delays – largely due to the COVID-19 pandemic – on April 11, 2023, the U.S. Environmental Protection Agency finally issued two proposals that would reduce ethylene oxide (EtO) emissions affecting fence-line communities neighboring EtO sterilization facilities and establish direct protections for facility employees likely to be regularly exposed to this sterilizing chemical. The proposals, which fall under the Clean Air Act (CAA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), are expected to dramatically reduce EtO emissions by a whopping 80% …

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New Sprawling EtO Litigations Mount as Our Pandemic-Shaken World Increasingly Relies on Commercial Sterilizers

Right on the heels of the eye-popping $408 million settlement between a major commercial sterilizer and plaintiffs claiming injuries resulting from exposure to ethylene oxide (EtO) emitted from the company’s Illinois facility (covered by ELM here), the company now faces two different legal actions initiated by two new groups of plaintiffs but similarly stemming from fugitive EtO emissions from the company’s U.S. facilities. These legal battles come at a time when there are not yet viable alternatives to EtO, a highly efficient medical-equipment sterilizing …

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EPA Renews Push for New ‘EtO’ Regulations and Outreach   

Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene oxide (EtO) emissions from 23 of specific sterilizer facilities.  

The agency further announced that, using data from the same study as well as ongoing critical EtO research, EPA will propose new regulations intended to protect public health from EtO emissions and protect workers at the facilities themselves, by the end of 2022 …

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Colorless Haze? Carcinogenic Gas Found at Monitoring Sites in 16 Cities

The U.S. Environmental Protection Agency (EPA) has released new data regarding the concentrations of ethylene oxide, a colorless and carcinogenic gas, found in metropolitan areas throughout the country. That data shows that the highest concentrations can be found in Phoenix, Arizona, followed closely by Chicago, Illinois, Calvert City, Kentucky, and Chester, New Jersey.

Ethylene oxide is an industrial compound most commonly used to produce other chemicals or as a sterilizing agent for medical instruments. The EPA released the data as part of an ongoing effort …

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Sterile storage of medical and surgical instruments in the dentist's office. View from above. Closeup shoot.

Two Strikes – Medical Equipment Cleaning Facility Hit with Over 30 Lawsuits, While its Doors Remain Closed by State Regulators

Over 30 personal injury lawsuits have been filed against Sterigenics LLC in Cook County, Illinois. The suits are the latest development in the company’s issues arising out of claims its medical equipment cleaning plant emits harmful fumes.

Jeanne Hochhalter is one of those suing Sterigenics. She claims that the cancer she developed is directly related to the plant’s release of the chemical ethylene oxide.

“I got breast cancer. I have no family history of it,” Hochhalter said.

A Sterigenics spokesman said the company “has consistently …

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EPA Releases Report Linking Sterilizing Chemical to Increased Risk of Cancer

The U.S. Environmental Protection Agency (EPA) has determined that a suburban area in Willowbrook, Illinois is facing a risk of cancer over nine times the national average due to contamination by ethylene oxide. Ethylene oxide has been used for decades as fumigant to sterilize heat-sensitive medical equipment and other goods. The volatile, easily absorbed chemical has been recognized as a carcinogen since 1985. In December 2016, the EPA released a re-assessment linking it more conclusively to breast and blood cancer.

Sterigenics International, a company that’s …

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