A Statement from ChemDAQ's Chief Technology Officer Regarding the EPA's Proposed 10 ppb Limit for Ethylene Oxide Exposure
May 22, 2023 (Pittsburgh, PA) - In April 2023, the US Environmental Protection Agency (EPA) issued proposed regulations that would set a new occupational ceiling for EtO exposure within a sterilization workplace of 10 ppb, above which respiratory protection must be worn by workers. The EPA has set a limit of 60 days for public comment on these proposed regulations. Following this comment period, the draft regulations may be different from the initial proposal after the EPA has considered input from experts across the industry. There are several steps to go before the EPA issues the final regulations, and the time before issuance is very uncertain, ranging from months to years. Once issued, the industry will have a period of time to implement changes to meet the new regulations.
ChemDAQ takes pride in our collaboration and partnership with the medical device sterilization industry, and we are committed to providing the best sensor technology available, including the lowest detection limit and specificity possible. ChemDAQ is continuously improving our sensor performance, and when our latest sensor technology is available, our customers automatically receive these improvements as part of our Sensor Exchange Program (SXP®).
ChemDAQ is currently working on developing a new sensor for EtO with a lower detection limit so that we can accurately, consistently and reliably detect EtO consistent with new regulations. We intend to complete the new sensor development, including all the necessary agency approvals, in time for the medical device sterilization industry to ensure compliance with these new regulations.
- Richard Warburton, Ph.D. | CTO & General Counsel
About ChemDAQ
ChemDAQ provides continuous monitoring solutions for 600 customers within the healthcare, medical device manufacturing, food and beverage packaging, and protein processing industries, helping them to create safer workplaces, reduce risks, and provide next-level protection for their teams. To learn more about ChemDAQ’s monitoring solutions, visit www.chemdaq.com.
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