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Commercial sterilization operations find themselves in a more unique and complex regulatory context than many other industrial sources of EtO. Unlike the chemical manufacturing industry, which can often make decisions about EtO usage based solely on the grounds of technical feasibility and costs, sterilizers may not be able to accept some methods of emission limitations, such as throughput limits (i.e., limits on how much EtO they can use in their processes in the first place), because sterilizers are also subject to independent regulations from the FDA, which actually require them to use EtO to sterilize certain products, and even can require certain amounts or concentrations of EtO to be used to ensure medical equipment is properly disinfected. This dynamic of potentially overlapping agency jurisdiction necessarily complicates EPA’s regulatory process for sterilization operations, since EPA not only has to account for dangers associated with EtO emissions, but also has to do so in a way that doesn’t infringe on FDA’s regulatory programs that protect the sterility of medical devices (thus protecting human health). COVID-19 introduced yet another reason to proceed with deliberate caution on any regulatory actions that limit sterilization operations in a way that could jeopardize the continuous availability of adequate medical supplies.

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EPA initiated the process for revising NESHAP O (the standards applicable to sterilization and fumigation operations) with an Advanced Notice of Proposed Rulemaking (ANPRM) on&nbsp;<a href="https://www.regulations.gov/document/EPA-HQ-OAR-2019-0178-0001">Dec. 12, 2019</a>. This ANPRM requested information and solicited public comment on various potential processes and approaches for reducing EtO emission from commercial sterilizers. One of the concepts initially proposed by EPA was to evaluate whether sterilizers could use less EtO in their processes, but FDA&nbsp;<a href="https://www.regulations.gov/document/EPA-HQ-OAR-2019-0178-0035">provided interagency comments</a>&nbsp;pushing back and asserting that use of EtO in the sterilization process was under the jurisdiction of FDA, and that EPA should limit its analysis and proposals to emissions rather than to use of EtO.&nbsp;<a href="https://www.medicaldesignandoutsourcing.com/fda-to-epa-leave-us-out-of-your-ethylene-oxide-rule/">EPA accepted and complied</a>&nbsp;with FDA’s comments. EPA then issued an information request on June 5, 2020, to the largest sterilization facilities in the nation to get a better understanding of the processes and emission controls that are available for reducing EtO emissions. Just last month, on&nbsp;<a href="https://www.govinfo.gov/content/pkg/FR-2021-05-10/pdf/2021-09794.pdf">on May 10, 2021</a>, EPA issued a follow-up notice in the federal register, proposing to extend its mandatory information request to all commercial sterilizers. In its&nbsp;response to OIG’s May 6, 2021 report&nbsp;(which will be discussed in a follow-up post), EPA represented that it currently expects to issue the NESHAP RTR for sterilizers in the fourth quarter of fiscal year 2022. Currently, NESHAP O only applies to facilities that use more than one ton per year of EtO for sterilization or fumigation, but any facility that relies on that applicability determination for exemption should closely track whether EPA lowers the thresholds in its upcoming proposed regulations. Operations already complying with NESHAP O should also be prepared for the new rule to require increased control efficiencies, given that EPA required 99.9% control efficiency for EtO in the recent MON NESHAP RTR (<a href="https://www.bakerenergylaw.com/blogs/emerging-chemical-issues-ethylene-oxide-part-3-of-5-challenges-to-the-iris-eto-ure/">see here for our prior discussion of the MON and EtO</a>).

EPA’s IRIS EtO URE has also had consequences beyond CAA regulations. As just one example, use of EtO in sterilization or fumigation is independently regulated by EPA’s Office of Chemical Safety and Pollution Control (OCSPS) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which governs manufacture and use of pesticides. Under FIFRA, all pesticides must be registered with EPA, and EPA must review each registered pesticide at least every 15 years to determine whether it continues to meet the FIFRA standard for registration. And FIFRA has the potential to affect more than just manufacturers of EtO, because the labeling required by EPA binds users of EtO as well, due to FIFRA’s provisions that make it a violation of federal law to use pesticides registered under FIFRA in a manner inconsistent with their labeling (subject to various exceptions). On Nov. 3, 2020, EPA’s OCSPS&nbsp;<a href="https://www.epa.gov/sites/production/files/2020-11/documents/d458706-eto-final-dra-nov-3-2020.pdf">issued a draft report</a>&nbsp;analyzing human health and ecological impacts of EtO as a sterilant, and determined that the current risk was high enough to propose changes to the EtO registration requirements under FIFRA to further mitigate EtO exposure. But notably, unlike the various NESHAP RTR proposed rulemakings that have been issued by the Office of Air and Radiation, the OCSPS FIFRA analysis acknowledged both the 2016 IRIS and the 2020 TCEQ studies as valid metrics for determining EtO-related exposure risks, and even noted that “while there is agreement on the association of EtO exposure with cancer of the lymphohematopoietic system, the assessments presented herein differ in concluding that there is insufficient evidence for breast cancer.” EPA&nbsp;<a href="https://www.epa.gov/pesticide-reevaluation/registration-review-schedules">expects to issue a proposed interim decision</a>&nbsp;on EtO registration requirements under FIFRA during the fourth quarter of 2021 (July-September 2021). In the draft Nov. 3, 2020 report, EPA previewed that “Mitigation options range from emissions abatement technologies, parameter monitoring, respiratory protective equipment, and the elimination of minor uses such as artifacts, archival materials, and library objects.” It remains to be seen whether EPA will use its authority under FIFRA to impose requirements on EtO users in addition to existing regulations under the CAA and employee protections under OSHA.

Emerging Chemical Issues – Ethylene Oxide (Part 4 of 5): Special Considerations Related to the Sterilization Industry