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Shareholders and other interested parties can communicate with our Board of Directors by email at: email@example.com. The Corporate Secretary reviews all communications sent to the Board. Inquiries that relate to the functions of the Board or a Board Committee will be relayed to the Board, Board Committee, or to individual directors, as appropriate. The Secretary will not relay to the Board or its members inquiries unrelated to the duties and responsibilities of the Board or its Committees, including solicitations, advertisements, job applications or resumes, service or product inquiries, complaints, or any materials that are threatening or illegal.
- Sterigenics operates 48 facilities in 13 countries to ensure medical devices, pharmaceutical products, and food are safe for people to use and consume.
- Sterigenics sterilizes and decontaminates products that protect over one million patients and consumers every day.
- This includes surgical instruments, catheters and procedure kits, IV administration sets, personal protective equipment (PPE) such as drapes/gowns, wound protection sleeves, tubing sets and many more.
- Without these essential devices, vital procedures would not occur and patients’ lives would be at risk.
- As explained by the FDA, for many medical devices, sterilization with EO is the only method that effectively sterilizes and does not damage the device during the sterilization process.
- Approximately 50% of sterile medical products in the U.S. are sterilized using EO.
- Without EO sterilization, infection risk associated with surgical procedures and other forms of care could be meaningfully increased.
- Sterigenics provides sterilization services using Gamma, EO, E-beam and X-ray technologies.
- Sterigenics does not determine which sterilization method to use. The method of sterilization is determined by FDA sterility requirements and the medical product manufacturer based on the materials and the design of the product being sterilized.
- In late 2019, the FDA stated, “there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”
- EO is in the air around us.
- EO is a common building block in many of the products we use in our daily lives, including household cleaners, personal care products and pharmaceuticals. It is also emitted by ordinary cooking activities, from car and truck engines and natural gas combustion, and is produced naturally by plants and the human body.
- Yes. Sterigenics’ facilities have been industry leading, consistently outperforming environmental regulatory standards for decades.
- EPA news release regarding Ethylene Oxide (November 19, 2020)
- Statement of the Advanced Medical Technology Association on Ethylene Oxide Sterilization of Medical Devices Before the Joint Hearing of the Illinois House Environment Committee and the House Energy Committee (October 25, 2018)
- U.S. EPA: Ethylene Oxide Ambient Concentrations at National Air Toxics Trends Stations and Urban Air Toxics Monitoring Program stations (October 1, 2018 – March 31, 2019)
- Kirman and Hayes, 2017 – Derivation of endogenous equivalent values to support risk assessment and risk management decisions for endogenous carcinogen: ethylene oxide
- FDA statement on concerns with medical device availability due to certain sterilization facility closures (October 25, 2019)
- FDA Overview on Ethylene Oxide Sterilization for Medical Devices
- Clinical Infections Diseases, Disinfection and Sterilization in Health Care Facilities: What Clinicians Need to Know (September 1, 2004)
- Advamed: Ethylene Oxide and Sterilization
- BIO El Paso – Juarez Issue Paper: “Medical Device Sterilization in Santa Teresa, NM” (March 2021)
- Gamma Industry Processing Alliance (GIPA), “A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products (August 31, 2017)
- FDA statement on concerns with medical device availability due to certain sterilization facility closures (October 25, 2019)
- EPA Basic Information about the Integrated Risk Information System
- Competitive Enterprise Institute, EPA’s Flawed IRIS Program Is Far from Gold Standard (February 11, 2019)
- Emerging Chemical Issues – Ethylene Oxide: Why It Matters (June 4, 2021)
- Science Advisory Board Review of the EPA’s Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (August 7, 2015)
- Joseph Goffman, Acting Assistant Administrator of U.S. EPA Office of Air and Radiation letter to EARTHJUSTICE attorneys Kathleen Ridley and Emma Cheuse (June 17, 2021)
- U.S. Government Accountability Office, “Chemical Assessments: Low Productivity and New Interagency Review Process Limit the Usefulness and Credibility of EPA’s Integrated Risk Information System,” GAO-08-440 (March 7, 2008)
- U.S. Government Accountability Office, “Chemical Assessments: Challenges Remain with EPA’s Integrated Risk Information System Program,” GAO-12-42 (December 9, 2011)
- National Research Council; Division on Earth and Life Studies; Board on Environmental Studies and Toxicology; Committee to Review EPA's Draft IRIS Assessment of Formaldehyde, Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde, Consensus Study Report (2011)
- American Chemistry Council: Ethylene Oxide Safety Facts (June 2, 2019)
- Texas Commission on Environmental Quality, Ethylene Oxide Carcinogenic Dose-Response Assessment (May 15, 2020)
- Montrose Air Quality Services Measurements of “Everyday Sources” for Ethylene Oxide (October 16, 2019)
- International Archives of Occupational and Environmental Health meta-analysis regarding cancer risks among workers exposed to EO (May 20, 2019)
- International Journal of Environmental Research and Public Health reevaluating historical exposures to EO among sterilization workers in the NIOSH study cohort (May 16, 2019)
- No generally accepted science demonstrates that low-level EO exposure from Sterigenics' facilities cause medical conditions.
- EO is a naturally occurring substance, unlike many other chemicals at issue in other environmental litigation.
- EO consistently occurs in the environment from natural/everyday human activity, often at levels above those to which the general public is exposed to long-term from the Sterigenics facilities.
- The EPA and others now acknowledge background levels of EO, contrary to the view the EPA took for some time after it published the IRIS EO assessment.
- A recent meta-analysis of studies regarding cancer risks among workers exposed to EO concluded that the most recent and informative studies on the topic “do not support the conclusion that exposure to EO is associated with an increased risk of lymphohematopoietic cancers (LHC) or breast cancer.”
- Another study reevaluated historical exposures to EO among sterilization workers in the National Institute of Occupational Safety and Health (NIOSH) study cohort that was relied upon by the EPA in its 2016 IRIS risk assessment. The review found that the trend in EO exposures during the study period was opposite to the trend indicated in the NIOSH study “suggesting that the US EPA’s exclusive reliance on the NIOSH cohort to estimate EO cancer risk should be re-examined.”
- Sterigenics consistently complies with environmental permits issued specifically for each of its sterilization facilities.
- Sterigenics disclosed its EO emissions for decades in federal and state filings, even when others in the industry did not.
- Sterigenics has implemented leading safety practices and continues to work with regulators and others to enhance the safety of EO sterilization.
- Pending claims are individual claims; results in one trial will relate to the individual claimants involved – Sterigenics will defend remaining claims as they go to trial over time.
- Although some pending claims are consolidated for efficiency in pre-trial proceedings, any trials are expected to address individual plaintiff claims, not claims of large classes of people.
- The Plaintiffs’ bar seeks to create a new kind of mass tort relating to this ubiquitous, naturally occurring substance emitted at permitted facilities.
- There is no precedent for liability for alleged personal injury or property damage related to low-level EO emissions from facilities consistently operating under governmental permits.
- Plaintiffs are represented by motivated attorneys across multiple jurisdictions, who will disagree with the evidence the Company presents and who will present differing evidence and allegations, including government reports suggesting long-term health risk at EO sterilization facilities.
- The cases are pending in multiple state court systems with varying procedures and law.
- Many cases are likely to be resolved in jury trials with associated uncertainty.
- Investors should review the latest Sotera Health Company Annual Report on Form 10-K and the latest Sotera Health Company Quarterly Report on Form 10-Q including the section titled “Cautionary Note Regarding Forward-Looking Statements” in each, for a detailed discussion of Risk Factors and litigation affecting the Company.
NESHAP are stationary source standards for hazardous air pollutants. The regulation sets standards for allowable emissions levels, as well as a framework for ongoing compliance and inspection (i.e., reviewing records, inspecting facilities, interviewing personnel).
The medical sterilization industry has been anticipating an update to EO regulation under NESHAP for multiple years. A notice of proposed rulemaking is anticipated during 2022, with a final rule to follow completion of the rulemaking process. Sterigenics is making investments today to best position its EO sterilization facilities for compliance with future regulations.
Recent controversy related to EO is ultimately grounded in a study published in December 2016 by EPA’s Integrated Risk Information System program (IRIS). IRIS assessments are a source of information used by EPA, state and local health agencies, other federal agencies, and international health organizations. It is not a safety limit and is not intended to be a regulatory standard.
In 2016, EPA’s IRIS group completed a review and reclassified EO from “Probably Carcinogenic” to “Carcinogenic” and updated its inhalation unit risk estimate. During this multi-year review, EPA’s independent Science Advisory Board (SAB) raised several questions about the basis for these conclusions. The IRIS group’s final report failed to resolve those questions.
The IRIS update gained attention in 2018, when the EPA used it to evaluate nationwide cancer risks as part of its National Air Toxics Assessment (NATA). NATA’s computer-simulated assessment combined the widely disputed IRIS inhalation unit risk estimate with outdated 2014 public emissions data from facilities across the country that are not always reflective of current emission control systems. This flawed analysis implied that 106 census tracts across the country, including the Sterigenics facilities located in Willowbrook, IL, Smyrna, GA, and Santa Teresa, NM, were identified as having an elevated risk of cancer due to EO, including several locations near other medical sterilizers that use EO.
The IRIS value of 0.1 parts per trillion of EO is an inhalation unit risk estimate, which assumes that inhaling EO 24 hours per day, 7 days per week for 70 years might increase the risk that 1 additional person in 1 million will get cancer.
The IRIS program has been widely questioned in the past by reputable organizations such as the Government Accountability Office and a National Academy of Sciences panel. EO exists naturally at concentrations significantly exceeding the IRIS value, including in the human body.
For many medical devices, EO is the only sterilization method that effectively sterilizes without damaging the device during the sterilization process. Medical devices made from certain polymers (plastic or resin) or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with EO.
The method of sterilization for a particular product or device is determined by the medical product manufacturer based on a variety of considerations, including FDA sterility requirements and internationally agreed consensus standards, the materials used and design of the product being sterilized, and the intended use of the product. Without EO sterilization, infection risk associated with surgical procedures and other forms of care could be meaningfully increased.