Who is Sterigenics?
Sterigenics is a global leader in mission-critical sterilization solutions and expert advisory 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 Health. TM .
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 and reduce the microbes often found on spices. The ethylene oxide used to sterilize medical products or treat spices is less than 0.5% of the total amount of EO produced 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 your 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 cigarette smoke or auto exhaust emissions. According to World Health Organization data, cigarette smoke releases 1,100 times more EO than the lowest canister reading in the recently published ATSDR report.
Commercial sources of EO can come from chemical manufacturers, hospitals and medical sterilization facilities near where people work or live. In fact, there are more than a dozen medical facilities located in DuPage and Cook counties that use EO to sterilize medical products and also emit EO.
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, who use these products, from harmful bacteria that could cause infection or death. 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 Willowbrook comply with all EPA Ethylene Oxide emission limits?
The Sterigenics’ Willowbrook ethylene oxide facility operates in full compliance with its environmental permit. Willowbrook’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 Illinois EPA for air emission reductions. USEPA and Illinois EPA are aware of our strong compliance track record and have approved permits for all of our operations.
What are the two reports that were released?
The reports were both issued by the Environmental Protection Agency (EPA) and a related federal regulator, the ATSDR (Agency for Toxic Substances and Diseases Registry).
The first is the NATA (National Air Toxics Assessment) Report. This is a national report that shows data on air toxic emissions every three years. The report that was released is based on 2014 emissions data.
The second report is the ATSDR report. The ATSDR report is a technical report on recent emissions monitoring for a limited period in May 2018 near the Willowbrook facility. As stated by the ATSDR, the report “is to inform and support the regulatory decisions being made by the state and EPA to reduce emissions from that facility to protect public health.” However, the ATSDR report does not account for the recent voluntary upgrade completed at the Willowbrook facility that reduced emissions by 90%.
How is Sterigenics responding to the ATSDR report?
Sterigenics just received the ATSDR report and was not given the opportunity to review it prior to its release. Based on our review to date, Sterigenics has serious concerns about whether the ATSDR report accurately reflects risk in Willowbrook because the data does not reflect recent emissions reductions and because the analysis is based on a recent and controversial EPA study of ethylene oxide risk. EPA’s risk evaluation is so conservative and potentially unrealistic that it would consider the EO levels produced by your body’s normal metabolic process to be unsafe. However, in the most recent statement made to the Village of Willowbrook, the ATSDR states “The emissions of ethylene oxide from the Sterigenics International, Inc. facility in Willowbrook, IL are not an immediate threat to public health and are not considered to be an emergency situation.” For additional information on these recent statements, please visit Village of Willowbrook Statements.
Why is Ethylene Oxide the focus of the EPA?
Across the country, USEPA is taking steps to address emissions of ethylene oxide from some types of industrial facilities. The ATSDR report indicates that exposure to emissions from EO presents a greater degree of risk than previously believed. However, in a statement to the Village of Willowbrook, EPA states “based on an examination of available data, USEPA does not expect ethylene oxide levels in the air to be high enough to cause immediate harm to health.” For additional information on the most recent statement from USEPA, please visit US EPA Statement to Village of Willowbrook.
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. We monitor the EO emissions both within and outside our facility to protect our employees and the community. We have state-of-the-art equipment to monitor EO levels, and extract EO from the sterilization process through emission control equipment. We conduct quarterly badge monitoring to monitor EO exposure within our facilities to safeguard the health of our employees. Sterigenics’ EO facilities, including the Willowbrook facility, operate in compliance with all of their applicable environmental permits. Through voluntary upgrades, ethylene oxide emissions from Sterigenics’ 13 U.S. EO facilities have decreased on average more than 40% since 2014. We are committed to continuously improving safety practices at all our facilities.
What additional measures are in place at the Willowbrook facility to ensure air quality safety related to Ethylene Oxide?
Sterigenics is committed to continuously improving safety practices at all of our facilities. In July 2018, we completed a voluntary upgrade at the Willowbrook facility that reduces the current ethylene oxide emissions in Willowbrook by over 90%. We have proactively worked with the USEPA and Illinois EPA to gain approval of these emissions reduction improvement measures.
What plans does Sterigenics have to keep the air quality safe related to Ethylene Oxide?
Sterigenics will continue to meet or exceed our air permit requirements, and is committed to ongoing continuous improvement initiatives, and to working with USEPA and Illinois EPA to ensure a safe environment for our employees and the communities in which we operate.
Is it true that Sterigenics’ facilities pose an unacceptable amount of cancer risk to the people who live nearby?
No, we do not believe so. In a recent statement made by the ATSDR to the Village of Willowbrook, the ATSDR states, “The emissions of ethylene oxide from the Sterigenics International, Inc. facility in Willowbrook, IL are not an immediate threat to public health and are not considered to be an emergency situation.” For additional information on these recent statements, please visit Village of Willowbrook Statements. Additionally, the ATSDR report does not address the impact of a voluntary operational improvement that was installed at the Willowbrook facility in July 2018 that resulted in a 90% reduction in EO emissions.
What are the details of the compliance issues that the Willowbrook facility had in 2013?
In 2013, the Sterigenics Willowbrook facility had two separate environmental-related notices of violation. The first issue was an ethylene oxide (EO) leak that occurred when the acid scrubber at the Willowbrook facility on Quincy Street shut down and approximately 12 pounds of EO was released to the atmosphere. The second issue was a release of ethylene glycol (a different chemical than ethylene oxide) that leaked from its containment. In both instances, Sterigenics voluntarily reported the issues to the regulatory agencies and corrective actions were implemented immediately. In 2015, Sterigenics entered into a Consent Order with the State of Illinois regarding these claims.
What EO monitoring systems does Sterigenics have in place at its Willowbrook facility?
The Sterigenics Willowbrook facility uses multiple methods to detect and monitor EO within the facility. 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 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. The facility has procedures in place to respond to the monitoring systems. As an added safeguard, the facility has handheld monitors that are used for specific monitoring.
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 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. Thorough training, corporate auditing and steps for continuous improvement are integrated into this system. The specific EH&S procedures include thorough procedures for environmental compliance, environmental control systems, ethylene oxide requirements, emergency planning, hazardous materials and process safety. The system also includes a separate set of Emergency Operating Procedures that are used specifically to respond to any EO leaks or releases.