The Society of Interventional Radiology (SIR) predicts “significant” patient care “disruptions” will result from the EPA’s proposed regulations to slash ethylene oxide (EtO) emissions by 80 percent, according to Radiology Business.

 

“SIR, the American College of Cardiology and several other medical societies note that [EtO] is vital for the proper disinfection of catheters, stents, guiding sheaths and other supplies. Interventional radiologists have limited alternatives, some of which are ‘suboptimal.’

“‘We are concerned that the proposed rule as written could result in significant disruptions to the medical supply chain and our ability to care for our patients,’ the [SIR] and others wrote in public comments submitted June 27, the final day to do so,” Radiology Business adds. “We urge the EPA to work closely with the [Food and Drug Administration (FDA)] and relevant stakeholders to implement updated national standards to reduce EtO emissions that provide sufficient time and flexibility for sterilization facilities to comply in order to ensure continued patient access to critical devices.”

EtO is a colorless gas produced in large volumes at some chemical manufacturing facilities. Nationwide, the gas is used to make a variety of products, including antifreeze, textiles, plastics, detergents, and adhesives. It’s also used to sterilize devices that can’t be sterilized using steam or radiation, such as some medical and dental equipment. According to the FDA, approximately 50 percent of sterile medical devices are treated with EtO. The food industry also uses EtO to sterilize food products such as spices, dried herbs, dried vegetables, sesame seeds, and walnuts.

EtO primarily enters the environment through the air, and people are typically exposed by breathing air containing the gas. EtO is also a human carcinogen.

“Scientific evidence in humans indicates that regular exposure to EtO over many years increases the risk of cancers of the white blood cells, including non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia. Studies also show that long-term exposure to EtO increases the risk of breast cancer in women,” according to the EPA’s EtO website. “Workers who use EtO as a part of their jobs and people who work, live, or go to school or daycare near facilities that use EtO may breathe in EtO at levels that can increase cancer risk. This risk is not the same for everyone and depends on how long a person is exposed over the course of their lifetime or career, as well as how much EtO is actually in the air. The distance from a facility or other EtO source plays a big role in how much EtO might be in the air.

“The greatest risk is for people who work for their entire careers at facilities directly handling EtO with minimal worker protections in place.”

Proposed EtO regulations

On April 11, 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.

“… the proposal will require all 86 (existing) facilities and any new facilities to comply with these stricter pollution controls, which have already proven to be effective and achievable,” the EPA news release says. “All commercial sterilizers will also be required to use advanced source monitoring methods to confirm that these pollution controls are operating effectively. Facilities would be required to report results to EPA twice per year. Under the proposal, facilities would be required to comply with these new requirements within 18 months. This represents an expedited timeline under EPA authority.”

The second proposed regulation falls under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), under which the EPA approves the use of pesticides subject to certain controls through a registration decision, including antimicrobial pesticides like EtO. The new proposed regulation will increase control measures on the use of EtO in the Proposed Interim Decision, such as:

• 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.

Industry challenges

“The societies emphasized that they support efforts to reduce community exposure to EtO,” notes Radiology Business. “But they believe any proposal needs to be balanced to ensure the ‘supply chain of critical medical devices and patient care are not put at risk.’”

“EtO sterilizes an estimated 95 percent of all surgical kits. And it is the only effective, viable sterilization method for many medical devices,” according to comments on the proposed regulations submitted by the Advanced Medical Technology Association (AdvaMed). “For these sensitive and intricate devices, there is no existing alternative method for sterilization. … Amid tremendous demand in the U.S. healthcare system for sterile medical technologies, EtO sterilization is already at capacity. If the NESHAP is not reasonable and feasible (both economically and technically), it will further constrain capacity and jeopardize the availability of sterile medical devices and supplies (with no ability to shift that capacity across the market).”

Comments from Medline Industries LP included concerns about the expedited timeline for compliance within 18 months once the regulation is finalized.

“[The EPA] proposes 18 months for completion of emission controls in the NESHAP. Facilities not currently meeting the proposed NESHAP standards cannot meet EPA’s proposed timeline,” states Medline’s comment letter. “There are relatively few emissions control equipment suppliers. Those entities have constraints on the number of projects that can be implemented at the same time. Medline completed its upgrade project in approximately 22 months, but only due to its relatively small size, conducive site layout, and the lack of equipment sourcing pressure from other facilities simultaneously making similar upgrades.  We anticipate that existing facilities will need considerably more time.  Additionally, Medline’s improvements occurred prior to the COVID-19 pandemic, which continues to have ripple effects in overall supply chain cost and lead times. Transformers and switch gear, which are necessary for electrical improvements to accommodate additional emissions control system upgrades, have lead times ranging up to 17-20 months.

“If Clean Air Act (CAA) timelines did not apply, Medline would request [the EPA] to provide at least five years to allow for NESHAP-related enhancements to help offset industry-wide capacity restrictions during emissions system upgrade installation. However, given statutory limitations, we respectfully request that [the EPA] provide no less than four years for compliance (36 months under Section 112(i)(3)(A) of the CAA and an additional 12 months pursuant to Section 112(i)(3)(B) of the CAA). [The EPA] should use every operational flexibility at its disposable to prevent medical device shortages.”

Comments received from Elite Spice Inc. indicate the food industry faces similar challenges with an 18-month implementation timeline.

“Due to the known inherent risk of bacterial contamination in spice, we are worried that EPA’s proposed accelerated timeframe would risk the safety of the food supply chain,” the Elite Spice comment letter says. “To transition entirely away from EtO, the spice industry needs more time to explore viable alternatives while still maintaining the supply of safe, clean spices to the food industry. There are currently limitations for viable treatment alternatives for a number of spice products. If EPA wanted to expedite the move away from EtO, EPA should align the label usage of propylene oxide (PPO) to match that of EtO thereby allowing a known effective alternative treatment method for more products.”

Comments received from the Alliance of Nurses for Healthy Environments indicate support for the proposed regulations and include the following recommendations:

• Strengthen EtO emissions standards for commercial sterilizers, and continue relying on the 2016 IRIS risk assessment, the best-available science.
• Consider cumulative impacts of EtO and other hazardous air pollutant emissions when assessing risk.
• Expand coverage of the rule to include off-site warehouses, where newly sterilized equipment is often stored and continues to off-gas EtO. Off-site warehouses must be required to control and monitor emissions.
• Require all commercial sterilizers to demonstrate compliance through continuous emissions monitoring systems, and require all commercial sterilizers to install fenceline monitors. Fenceline monitoring is necessary to understand ambient EtO concentrations that communities may be exposed to.
• Require all facilities to obtain a Title V permit, and remove the startup, shutdown, and malfunction reporting loopholes.
• Communicate risks to communities affected by EtO emissions, particularly to Spanish-speaking communities that are disproportionately impacted, and work to alleviate harms to fenceline and overburdened communities.
• Require facilities to comply with the rule sooner than the proposed 18-month time frame.
• Work toward phasing out the use of EtO in sterilization as much as safely possible. Less toxic alternatives are available.

The EPA has a consent decree deadline to issue a final rule no later than March 29, 2024.