Risky Business: Ethylene Oxide Business Closures Prompt FDA Alert; EPA Regulations to Follow

Posted on January 6, 2020 by David Tripp

Plant closures of medical equipment sterilization facilities in Chicago and Atlanta prompted the Federal Drug Administration to issue a statement on potential shortages of surgical and medical devices across the country. On October 25,  FDA Commissioner Sharpless noted the closure of two large sterilization facilities resulting in a shortage of pediatric breathing tubes and said, "The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care."

The FDA underscores an important dilemma in environmental matters: when risk assessment information based on emerging science predicts cancer-causing effects at extremely low concentrations, how can citizen concerns be addressed while EPA is developing regulations to minimize impacts on health and protect availability of necessary goods and services?

What is EPA's role in these plant closures?  In the Chicago suburb of Willowbrook, EPA participated in public meetings and confirmed the Sterigenics facility was permitted under the Clean Air Act and operating within permit limits. Sterigenics used Ethylene Oxide (EO or EtO) to sterilize medical devices. EO is uniquely suited for use on medical devices and is the most common sterilizing agent  in the U.S., safeguarding an estimated 50 billion medical devices annually including surgical kits for C-sections, cardiac and knee surgeries, and feeding tubes for neonatal care units. At Willowbrook, based on community health concerns, EPA asked ATSDR for input. ATSDR issued a Letter Health Consultation on August 21, 2018, stating that if measured and modeled data represent typical EtO concentrations in ambient air, an elevated cancer risk exists, and the Illinois Department of Public Health should investigate any elevated cancers in the surrounding population.

IDPH followed with its Cancer Incidence Assessment report, covering 1995 through 2015, finding increases in certain cancers, but concluding that limitations in methodology and data existed. IDPH strongly recommended future studies with larger populations, preferably involving multiple EtO emissions sites to confirm the assessment's findings.

The recommended longer term emission reductions and studies did not happen. Public opposition resulted in lawsuits seeking injunctive relief, and a Seal Order was filed by the State of Illinois. Sterigenics reached settlement with the State to allow reopening with additional emission controls, then closed both Willowbrook and a similar facility in Atlanta. Sterilization facilities which have closed, or are facing public pressure, are caught in a predicament of compliance with existing Clean Air permit requirements being overtaken by local and public pressure. EPA has begun the development of a numeric standard for EO, but in the interim a calculated risk screening level for EO at the 0.10 part per trillion threshold became the de facto control number. However, that threshold number is being hotly debated and one state has indicated it will promulgate a limit 40,000 times higher.  

The concerned citizens and municipalities believe the right result was reached when the facilities closed. FDA and the medical community believe a crisis in availability of sterilization for medical devices and instruments is foreseeable. For the companies, operation in compliance with federal and state permits did not offset sudden forces leading to closure. EPA has announced its "Suite of Actions to Address Ethylene Oxide," including proposed rulemakings for two sets of EO emission standards. The fair notice of these EPA regulatory actions  contrasts with the abrupt pressure for closure forced on the shuttered companies by a risk assessment more commonly used as the beginning step in a screening process that leads to a balanced decision on remedial actions.

Whether EPA and FDA can cooperate effectively to prevent critical shortages of sterilized medical devices remains to be seen. Until a viable option to EO sterilization of medical devices is found and implemented, medical sterilization remains a risky business.