The EPA’s proposed rules on regulating ethylene oxide (EtO) have sparked a catfight between the EPA and the Food and Drug Administration (FDA), according to several sources.
In April 2023, the EPA issued two proposals aimed at reducing EtO emissions, including more stringent air emissions standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and certain spices.
A 2016 report issued by the EPA determined, with “high” confidence, that EtO is “carcinogenic to humans.”
Coming on the heels of the COVID pandemic, when the world saw severe breakdowns in the supply chain, particularly in the supply of medical devices and equipment, those in the medical community and industry have dire predictions about the impact of any regulations that suddenly strictly restrict the use of EtO.
“This chemical is pretty hard to get rid of right now. EtO has numerous uses, but crucially helps sterilize half of all medical devices in the U.S., according to the FDA,” notes Axios. “That’s about 20 billion devices, including everything from syringes to surgical gowns to pacemakers.”
“‘We do have concerns’ about the EPA proposal, FDA commissioner Robert Califf testified to Congress in May,” Axios continues. “‘A sudden restriction would create substantial difficulty with critical medical devices. EPA is in the lead in this. We’re working on it. There’s an interagency process.’”
In fact, on the same day the EPA announced its proposed rules on EtO, the FDA announced the launch of a pilot program to incentivize companies to “advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.”
EPA authority to regulate EtO comes under the Clean Air Act (CAA) in two areas:
- The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the EPA to regulate certain pesticides, which include EtO because it’s classified as an antimicrobial pesticide. New control measures proposed by the EPA include:
- Prohibiting certain uses of EtO when alternatives exist, including use in museums, archival settings, beekeeping, some cosmetics, and musical instruments;
- Reducing the amount of EtO that may be applied for medical device sterilization while meeting applicable standards for sterility assurance;
- Requiring engineering controls that reduce worker exposures to EtO, such as automation or emissions capture technology; and
- Mandating personal protective equipment (PPE) in sterilization facilities when EtO is detected using state-of-the-art monitoring technology.
- National Emission Standards for Hazardous Air Pollutants (NESHAP) for commercial sterilization facilities, which are stationary source standards for hazardous air pollutants. The proposed standards outline new requirements for 86 commercial sterilizers across the country. If finalized, the proposal would reduce EtO emissions from these facilities by 80%, bringing emissions levels down so that risk falls below the EPA’s CAA benchmark for elevated cancer risk.
Health risks associated with EtO are the most immediate problem for those who live near facilities using the chemical.
On August 3, 2023, the EPA announced its intention to release “new information on specific facilities where lifetime risk levels are the highest to people who live nearby and is encouraging impacted communities to participate in a series of public engagements to learn more.”
According to Axios, “an EPA spokesperson said the agency is working with FDA on potential supply chain issues.
“‘EPA’s goal is to lower cancer causing EtO exposure to workers and community members, while maintaining the integrity of the supply chain so that patients and providers have continued access to the sterile devices they need,’ the spokesperson told Axios.
“Medical device makers, who also say they want to eventually move away from EtO, said the EPA is moving too aggressively in the absence of an EtO alternative. They argue the EPA proposal overestimates the health risks of EtO by assuming maximum emissions levels over many years, while a medical device shortage could harm people immediately.”
Meanwhile, the official line regarding the two agencies’ ongoing disagreement over regulating EtO is that the EPA and FDA will continue to work together to determine the best approach.
“Although the public nature of this interagency disagreement is unusual, the FDA has signaled that it is still working on fulfilling its promise to work with commercial sterilizers to find an alternative to EtO in order to advance the goals of the new EPA rules,” says a JD Supra article by Goldberg Segalla. “Whether the EPA will further pump the brakes and heed the FDA’s exhortation that its agency cousin be judicious and cautious in pushing its more aggressive new EtO emissions standards during our COVID hangover, however, has yet to be seen.”