FAQs
Who is Sterigenics?
Sterigenics is a leading provider of mission-critical sterilization services for the healthcare industry. Sterigenics provides contract sterilization services using gamma, ethylene oxide (EO), Ebeam and X-ray technologies for the safety of the medical device, pharmaceutical, food and high-performance materials industries. Its global network consists of 47 facilities in 13 countries. Sterigenics is committed to its mission of Safeguarding Global HealthTM.
What is Ethylene Oxide (EO)? What are sources of EO emissions?
Ethylene oxide (EO) is a gas used in the production of a wide range of products. Ethylene oxide is also used to sterilize medical equipment and devices. The ethylene oxide used to sterilize medical products is less than 0.5% of the total amount of EO used in the United States.
Ethylene oxide in the atmosphere can come from several different sources, including natural sources, everyday activities and commercial industries.
Natural sources of EO can come from plants, microbes and ripening fruits. Additionally, ethylene oxide is internally produced by the human body as part of its normal metabolic process. Published research on Internally Produced Equivalent EO values (Kirman and Hayes 2017) concluded that the mean normal internally produced level of EO for a non-smoker is 19,000 times greater than the risk level stated in EPA’s Integrated Risk Information System (IRIS) risk assessment.
Everyday sources of EO can come from gas grills, home furnaces, lawn mowers, auto and truck exhaust emissions, and cigarette smoke. Commercial sources of EO can come from chemical manufacturers, hospitals and medical sterilization facilities near where people work or live.
How does Sterigenics use Ethylene Oxide?
Ethylene oxide is a gas that is used by Sterigenics to sterilize medical products, which is a critical step under Food and Drug Administration (FDA) standards to protect patients from harmful bacteria and other microorganisms that could cause infection or death. Because many medical products are sensitive to heat and radiation, many medical products can only be commercially sterilized with ethylene oxide. In fact, nearly 90% of surgical kits and over 50% of all sterilized medical devices used within the United States are sterilized with ethylene oxide.
Does Sterigenics Atlanta comply with all EPA Ethylene Oxide emission limits?
Yes, as the Georgia EPD reiterated on July 25, 2019 (read here), the Sterigenics Atlanta facility operates in full compliance with its environmental permit. Sterigenics’ Atlanta facility’s air pollution control equipment is state-of-the-art, and the facility achieves and exceeds all compliance requirements set by the U.S. Environmental Protection Agency (USEPA) and Georgia EPD for air emission reductions.
Is it safe for me to be at or near an EO facility? Should I be concerned that I am exposed to EO?
We take the safety and well-being of our employees and the communities in which we do business very seriously. You are safe and do not need to be concerned.
We have state-of-the-art equipment to control the EO emissions from our EO sterilization process. We monitor the EO emissions both within and outside our facility to protect our employees and the community. We also conduct quarterly badge monitoring to measure the employees’ EO exposure within our facilities for their safety and health. Sterigenics’ EO facilities, including the Atlanta facility, operate in full compliance with all applicable environmental regulation and permit requirements. Through voluntary upgrades, we have reduced emissions from our facility in Atlanta by approximately 90% since 2014. We have also identified further emission reduction improvements that will further reduce our EO emissions. We are committed to continuously improving safety, health and environmental practices at all our facilities.
What additional measures are in place at the Sterigenics Atlanta facility to ensure air quality safety related to Ethylene Oxide?
Sterigenics is committed to continuously improving environmental, health and safety practices at all of our facilities. We are working with the Georgia EPD regarding additional voluntary enhancements that are consistent with changes being undertaken in other Sterigenics facilities and will further reduce EO emissions from the facility to negligible levels.
Is it true that the Sterigenics Atlanta facility poses a cancer risk to the people who live nearby?
No. On July 25, 2019, the Georgia EPD (read here) reaffirmed that Sterigenics Atlanta facility is in compliance and noted that the risk from EO concentrations in residential areas near the facility is below the level the EPA uses as a general guide for determining the maximum acceptable lifetime cancer risk.
What EO monitoring systems does Sterigenics have in place at its Atlanta facility?
The Sterigenics Atlanta facility uses multiple methods to detect and monitor EO at the facility for the protection of its employees and the surrounding community. We continuously monitor key parameters for our emission control systems to ensure they are working properly and we regularly test the facility’s emission control systems to ensure they meet the regulatory limits and permit requirements for EO emissions.
We also carefully monitor the EO levels within the facility to ensure its safe operation and to protect our employees. This series of detection methods ensures the safety of our employees and gives immediate indication of any EO levels in a working area. The detection methods used in our Atlanta facility include a Gas Chromatograph (GC) system to detect low parts per million (ppm) levels in working areas and Lower Explosive Limit (LEL) monitors that detect higher levels of EO (in % LEL) that are strategically placed in areas where any leaks can be detected quickly and alert facility employees. There are also handheld EO monitors available and for monitoring specific areas or tasks. In addition, the facility has detailed procedures and employee training in place to respond to the monitoring systems.
In addition to these monitoring systems, Sterigenics monitors employees’ EO exposure on a quarterly basis with passive badges to determine their exposure levels. The Occupational Safety and Health Administration (OSHA) has set an occupational permissible exposure limit (PEL) of 1 ppm and Sterigenics is in compliance with this exposure limit.
What is Sterigenics’ approach to managing Environmental Health & Safety (EH&S)?
Sterigenics has a corporate Environmental, Health & Safety (EH&S) Management System that has thorough procedures in place to manage the environmental and safety aspects of all of its operations. This management system is compliant with all applicable regulations and integrates all EH&S management components in one system. The management system establishes corporate environmental, health and safety policies, helps establish facility EH&S objectives, as well as includes EH&S procedures that govern all environmental and safety aspects and risks associated with operations. The specific EH&S procedures include thorough procedures for risk assessment, personal protective equipment, safety procedures, environmental compliance, environmental control systems, ethylene oxide controls, emergency planning, hazardous materials and process safety. Thorough training, corporate auditing and steps for continuous improvement are integrated into this system.