Ethylene oxide
This article has been updated with comments from the FDA.
The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied.
In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical device sterilization plants — the FDA suggested omitting a section in which the EPA discusses medtech sterilization.
Specifically, it describes a method in which a sterilizing company uses less EtO at the beginning of the process, and consequently lowers EtO emissions. The EPA then discusses the FDA regulation requiring manufacturers to validate the sterilization method for each device when they want to change that method. This can be a long and costly process, and one that manufacturers have told the FDA they don’t relish having to undertake. The FDA asked the EPA to strike that section.
(Excerpted from the EPA proposed rule on EtO emissions regulation)
“FDA believes this entire section is not relevant to EPA’s role of setting appropriate emission levels and monitoring emissions. FDA requests the deletion of this entire discussion about FDA requirements and matters within FDA jurisdiction,” the FDA comment says. “Moreover, this discussion focuses on devices when other FDA-regulated products are also sterilized. Therefore, it is incomplete. We request that EPA remove all references to FDA in this document.”
The EPA responded: “Given FDA’s work with exploring methods for reducing EtO use, the EPA will delete this section.”
The EPA began to solicit comments in December on its proposal to update its regulation of emissions of the carcinogenic gas from the commercial EtO industry. Public outcry in Illinois and Georgia linking EtO emissions from medtech sterilization plants to cancer and other illnesses has led to some crackdowns on EtO plant owners. The medtech industry and the FDA have expressed concern about public health, and continue to warn about possible medical device shortages.
The FDA provided comment to the EPA about its proposed EtO rule “to point out that setting emission standards should not be about medical device sterilization,” an FDA spokeswoman told Medical Design & Outsourcing in an email.
“It should be about protecting the environment and protecting people,” the spokeswoman said. “The FDA looks to the EPA to set allowable limits for ethylene oxide emissions because the FDA does not have authority over, nor the expertise in, setting emissions limits. Once emission standards are established, those limits would not impact how the FDA enforces sterilization requirements whether for ethylene oxide or another sterilization method. The makers of medical devices that require sterilization must meet FDA requirements for validating that the method used effectively sterilizes the device and does not adversely affect the materials or components of the device, thereby adversely affecting its performance. Sterilization facilities must meet EPA emissions limits to operate. The FDA will continue in its efforts to reduce over-reliance on ethylene oxide for medical device sterilization. Our actions, including the launch of our innovation challenge and the master file pilot, are illustrative of this commitment.”
The public and government agencies have until Feb. 10, 2020, to submit their comments to the EPA.
You can find the proposed rule and comments here.
