Chemical Safety Workers with PPE

The Urgent Need to Fix OSHA’s Ethylene Oxide Standard

Despite decades of scientific evidence linking ethylene oxide to cancer and other serious health effects, OSHA’s 40-year-old exposure limits continue to leave medical sterilization and manufacturing workers at risk. Updated regulations, real-time monitoring, and stronger protections are urgently needed.

For over a century, federal workplace safety laws have alarmingly exposed countless workers to hazardous chemical levels now recognized by modern toxicology as human carcinogens. This is because ethylene oxide (EtO)—a combustible and colorless gas integral to sterilizing medical devices and manufacturing pharmaceuticals, as well as many other products—remains governed by outdated exposure standards that do not accurately reflect its current elevated risks. Tragically, that troubling gap between the scientific understanding of this compound and existing rules for its use has subjected workforces to grave danger. Until the country’s Occupational Safety and Health Administration (OSHA) immediately implements a new regulatory framework, employees whose jobs require them to handle this substance will continue to face daily hazards. The need for this comprehensive reform has become much more urgent and undeniable. It is time to take decisive action to safeguard these vulnerable workers and truly secure their safety and well-being.

Ethylene Oxide Continues to Compromise the Health of Thousands of Workers

Every day, many hospitals and pharmaceutical companies nationwide rely on EtO to keep their medical equipment sterilized, including wound dressings, stents, catheters, and other tools used in general practices. In fact, roughly 50% of all medical devices in the country are processed with this chemical—underscoring its essential role in modern healthcare. Yet while EtO has been proven to effectively kill microbes without damaging sensitive instruments, it poses a serious risk to human health. Decades of research have strongly associated long-term exposure to this substance with various forms of cancer, most notably leukemia, lymphoma, and tumors of the breast, brain, lungs, uterus, and connective tissues. Even minimal contact can also irritate the skin or eyes and increase the likelihood of developing neurological disorders, pulmonary edema, bronchitis, and emphysema.

Recent analyses by the Environmental Protection Agency (EPA) underscore the urgency of this issue. Accordingly, their investigations identified at least 23 sterilization facilities in the country, which significantly exceeded the 100 in a million unacceptable cancer risk rate. In Willowbrook, Illinois, for instance, air quality modeling around the Sterigenics Facility indicated cancer risks 64 times higher than the federal benchmark. Similarly, tests conducted at Midwest Sterilization Corporation in Laredo, Texas, revealed 350 times above the safety levels set by the EPA. What’s disconcerting is that these areas were not violating federal law—they were compliant on paper and operating under standards that failed to keep pace with what today’s science recognizes as safe. Worse, the danger is not only limited to workers inside sterilization facilities. Because EtO can be discharged and dispersed into the air, communities surrounding contaminated sites may also be unknowingly exposed and yield adverse health impacts over time. Such a reality essentially demands accountability and immediate action to prevent further harm to more lives.

OSHA’s Outdated Standards and Regulatory Gaps

The immense threat of EtO has already been recognized for a very long time. But the permissible exposure limits enforced by OSHA for this chemical have not been updated meaningfully since 1984. The rule still allows workers to inhale concentrations that modern science shows can significantly increase cancer risk. And though OSHA requires periodic sampling and some engineering controls, the standard does not mandate real-time monitoring, continuous exposure tracking, or long-term health surveillance. As such, compliance with these outdated rules still does not guarantee that workers are actually protected.

This regulatory lag is particularly striking given that even other federal departments have also acknowledged the detrimental effects of inhaling EtO. True to this, the EPA formally classified it as a human carcinogen in 2016. And just earlier this year, it released an interim decision finalizing protections for workers and communities vulnerable to the arising pollution. Based on its guidelines, the EPA intends to lower the exposure limit to 0.5 parts per million (ppm) by 2028, 0.25 ppm by 2030, and 0.1 ppm by 2035. It also highlights the need for enhanced concentration monitoring, improved ventilation, and systematic tracking of employee exposure—protections that OSHA’s latest standard still does not strictly mandate. The result is a persistent gap between legal compliance and real-world safety. Workers on sterilization lines, as well as those in medical and pharmaceutical manufacturing, continue to operate under a framework that falls short of fully reflecting the confirmed hazards—leaving them highly susceptible even when employers meet federal requirements.

Protecting Lives Demands Updated Regulations and Stronger Protections

The outdated standards still implemented by OSHA—alongside its failure to act on the documented dangers of EtO—are not only a regulatory problem but also a direct threat to human health. Workers continue to face routine exposure to a chemical that is proven to cause cancer and many other life-threatening ailments, yet protections remain insufficient to address these risks. The data and lived experience are undeniable—without stronger safeguards, preventable illnesses will continue to occur.

To effectively address this urgent shortfall, OSHA must take bold and decisive action without delay. At this point, the federal department must revisit and revise the permissible exposure limits to finally reflect the most current toxicological science and align with the recent interim decisions issued by EPA. Employers must likewise adopt real-time monitoring as well as state-of-the-art ventilation systems and robust engineering controls to reduce exposure risks. In addition, the government must enforce long-term medical surveillance for all employees handling ethylene oxide to enable early detection of potential health effects. Lastly, transparency must be non-negotiable, which means workers must be provided with accurate and clear information about their exposure levels, comprehensive training, and independent verification of all safety measures in place. 

With these measures, OSHA could eventually bridge the gap between legal compliance and meaningful worker protection. The urgency of this action is evident: strengthening protections is not optional—it is a necessary, overdue step to safeguard lives, health, and public trust.

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