Blogs

New EPA Regulations for Ethylene Oxide Emissions

Ethylene oxide (EtO) plays a crucial role in ensuring the safety of medical devices. Medical device manufacturers use this colorless gas to sterilize various equipment and instruments. However, long-term exposure to EtO may increase the risk of cancer for workers and nearby communities. The EPA has proposed guidelines to significantly lower EtO emissions from commercial sterilization facilities to safeguard public health. The EPA regulations for ethylene oxide emissions aim to achieve an impressive 80% reduction in EtO emissions annually.  

Enhancing Safety and Compliance in Medical Device Sterilization: The EPA’s Regulations for Ethylene Oxide Emissions 

 The EPA has released two proposals in an attempt to mitigate the concentration of ethylene oxide (EtO) used for medical device sterilization. The first rule suggests lowering the EtO concentration to 500 milligrams per liter per cycle. This change addresses the fact that some facilities currently use more than twice the EtO than required for ensuring sterility. By setting a specific limit, the EPA aims to ensure that the EtO concentration used for sterilization aligns with what is necessary for effective and safe results. 

One of the proposed rule’s primary objectives is to ensure that all 86 commercial sterilizers comply with the new requirements. By establishing a clear concentration limit, the EPA seeks to standardize the use of EtO across the industry. Anita Pease, director of the EPA’s Antimicrobials Division, did not specify how many companies still need to reach compliance.  

The EPA regulations for ethylene oxide emissions also include a requirement for advanced monitoring and reporting of pollution control results to the agency twice a year. This provision will enable regular assessments of pollution control measures implemented by sterilization facilities.  

Protecting Workers and Residents from the Toxic Effects of Ethylene Oxide  

The agency’s comprehensive approach seeks to strike a balance between achieving effective sterilization and minimizing EtO use. Last year, the regulatory body introduced fresh reporting mandates for 31 facilities using EtO to sterilize equipment. Additionally, it released a roster of sterilization facilities with higher risk levels, accounting for the potential lifetime cancer risk for individuals residing in nearby areas. 

Unseen and dangerous, ethylene oxide emissions pose a hidden threat to the health and well-being of workers in sterilization facilities and the communities living in their vicinity. Therefore, another aspect of the EPA regulations for ethylene oxide emissions is the inclusion of engineering controls, such as emissions capture technology. These controls aim to effectively reduce worker and community exposure to EtO by containing the gas during sterilization.   

In addition to engineering controls, the proposed decision mandates that staff wear protective equipment when EtO is detected. This requirement ensures that workers have an added layer of protection in situations where EtO may be present.  

Ethylene Oxide Lawsuits Continue  

Although trade groups representing medical device companies are frustrated with the EPA’s restrictions, ethylene oxide has allegedly harmed hundreds nationwide.  

The issue of ethylene oxide exposure has led to a series of ongoing lawsuits involving medical device sterilizers. These cases allege chronic long-term exposure to ethylene oxide caused them to develop several forms of cancer, brain damage, memory loss, reproductive damage, and more.  

Recently, medical device sterilizer Sterigenics settled 870 ethylene oxide lawsuits for $408 million. These cases were linked to the alleged emissions stemming from Sterigenics’ former facility located in Willowbrook, Illinois.  

The Lake Law Firm Can Assist You in an Ethylene Oxide Lawsuit 

If you worked in a plant that used or produced ethylene oxide or lived near one and later developed cancer, you could recover compensation through an ethylene oxide claim. The EPA regulation for ethylene oxide emissions could help protect future generations from this carcinogenic hazard. However, we recognize that many have already been tragically impacted by ethylene oxide.  

Our firm is assisting victims of ethylene oxide to call for stricter regulations and heightened safety measures within the medical device sterilization industry to protect both workers and nearby communities from the harmful effects of EtO exposure. Contact us today at (888) 525-3529 to see if you qualify for an ethylene oxide exposure claim.