The Ethylene Oxide (EtO) sterilization standards saga has introduced a new twist. Under a consent decree signed in United States District Court during the last week of August 2023, the Environmental Protection Agency (EPA) has until March 1, 2024, to adopt new rules on commercial sterilization standards. The deadline leaves only eight (8) months to review the overwhelming number of public comments received for the proposed National Emission Standards for Hazardous Air Pollutants (NESHAP) and preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as conduct substantial analysis, regulatory drafting, and interagency policy coordination.
The push to update the standards for EtO stems from years of environmental groups and communities campaigning throughout the US. Additionally, Earthjustice on behalf of California Communities Against Toxics, Clean Power Lake County, Rio Grande International Study Center, Sierra Club, and Union of Concerned Scientists sued EPA in late 2022 on the grounds that 16 years had passed since it released updated EtO emission standards for sterilization facilities. Plaintiffs cited the Clean Air Act which requires EPA to review and revise standards “no less often than every [eight] years,” urging the Agency to release new standards as quickly as possible. The lawsuit resulted in a consent decree released for consultation earlier this year (in 2023) and has now been signed with the March 2024 deadline. “Today’s consent decree signing is a critical step to ensuring that communities across the US get needed protections from [EtO] emissions from commercial sterilizers,” said Marvin Brown, Earthjustice Senior Attorney, on the day the decree was signed. “For years, EPA has promised new regulations to rein in commercial sterilizers’ toxic [EtO] emissions. And after years of missing their own deadlines, we sued and secured a judicially enforceable deadline. Now EPA must do its part and ensure that its sterilizer rule protects communities from this cancer-causing pollution.”
The eight-month review period is a departure from previous rulemakings, which required a minimum of 18 or more months to address this level of public comments. An extension may be possible; however, only by “written stipulation of the parties with notice to the court,” or “by the court upon motion by EPA for good cause,” according to the decree. Much like the previous reactions during the ongoing EtO emission standards updating process, industry voiced concern about the March 2024 deadline.
Medical Device Manufacturers Association (MDMA) commented on the consent decree when it was still a draft, stating that “… the proposed settlement is inappropriate, inadequate, and inconsistent with the [Clean Air] Act.” The association posited that the short review period would not be sufficient to complete all steps necessary, be a waste of administrative and judicial resources, and could result in additional lawsuits. “EPA has substantial analysis, regulatory drafting, and interagency policy coordination to complete,” MDMA said. “The proposed decree deadline is inadequate for EPA to conduct these necessary tasks. Since EPA requires additional time to review the substantial public comments and to repropose the rulemaking, the consent decree is also inappropriate since it is not an efficient use of administrative and judicial resources.” The statement continued, writing, “If EPA rushes to meet the proposed deadline and publishes a final rule that either (1) does not address the substantive issues on the record; or, (2) does respond through final actions not adequately noticed in the proposal, EPA will inevitably be sued. The agency and the courts then will spend months or years and additional resources in litigation and in settlement. It would be a more appropriate and better use of EPA and the courts’ limited resources for EPA to spend more time, including a re-proposal, to produce a final rule that responds adequately to public comment.” MDMA itself submitted over 108 pages of comments during NESHAP and FIFRA’s commenting period.
The short timeline adds another layer to the divisive proposals. In comments submitted to NESHAP and FIFRA, industry expressed concern over how the proposed changes could negatively impact patient care and supply, while also creating additional ripple effects. In its submitted comments from the company, Scott Whitaker, Advanced Medical Technology Association (AdvaMed) president and CEO, wrote that “the medtech industry and EPA must continue working together to improve these two proposals because as written, we could see significant shortfalls and a risk to patient access resulting from a device sterilization capacity reduction of 30% to 50% nationwide.”
Additionally, MDMA highlighted how the cost of implementing new required pollution controls could shutter small sterilization firms unable to shell out the estimated $220 million in one-time capital investments as well as an additional $74 million to $86 million a year in recurring operating and maintenance costs on equipment. “The combined costs of both regulatory actions are likely to exceed $200 million annually,” according to MDMA’s submitted NESHAP comments. The costs, according to the association, could effectively close 20+ commercial sterilizer firms, and in turn, result in less medical device capacity, meaning fewer products would reach medical professionals and patients. “Health care facilities will then limit access to certain care since they will lack sufficient or the necessary sterile equipment,” according to MDMA. “Medical care will be delayed, increasing suffering and the risk of more severe patient outcomes.”
The proposed EtO standard changes come with an 18-month transition period, meaning that without an extension, affected industry would need to install all required pollution controls by Sept. 1, 2025, which AdvaMed sees as the bigger issue. “The question is not so much whether the EPA has enough time to finalize the rule as it is whether medical device sterilization facilities will be given enough time to comply,” Whitaker told MD+DI. “Especially considering the EPA is more than a decade behind in updating this regulation, we do not believe 18 short months for these facilities to implement the new requirements is enough, and if EPA ignores the input of multiple stakeholders and agencies on this point, there is a real risk that patients and providers will see a shortage of the sterile medical technologies and devices they rely on.” As it stands, the consent decree means industry could have an answer to the future of EtO sterilization in only eight (8) months… for better or worse.
REFERENCE: MD&DI (Medical Device and Diagnostic Industry); 30 AUG 2023; Katie Hobbins