Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules

Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a “devastating” impact on the medtech industry and patient access to life-saving products, according to two industry groups.

In April, the EPA published the two much-anticipated proposed regulations. If finalized, the rules would put additional limits on how much EtO can be released into the environment, how much of the agent can be used to sterilize products and how workers who handle the gas are allowed to operate in its proximity. (RELATED: EPA proposes rules on EtO with implications for medical device sterilization, Regulatory Focus 11 April 2023)

The agency previously released a report stating EtO sterilization facilities pose an increased cancer risk to neighboring communities; the aim of the proposed regulations is to reduce the risk of cancer for workers and people living adjacent to sterilization plants. (RELATED: EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end, Regulatory Focus 3 August 2023)

Medtech lobby groups AdvaMed and the Medical Device Manufacturers Association (MDMA) disagree with EPA’s assessment, and in comments made to the agency argued that EtO emissions from sterilization plants are hard to distinguish from background levels of EtO. They also warned that EPA’s proposed regulations could put a significant portion of the medical device sterilization industry out of business and others would have to pause their operations while coming into compliance with the rules – potentially leading to shortages of medical devices.

“The combined proposals would be devastating for patient access, and as FDA noted after the EPA began to look into this issue, without an adequate availability of EtO as a sterilization method, the impact to patient care would be catastrophic,” said MDMA CEO Mark Leahey.

Similarly, AdvaMed told EPA that the proposals would put even more burdens on an already stressed healthcare system.

“It is critically important that EPA recognize the importance of EtO in our healthcare system, and for individual patients,” said AdvaMed. “Amid tremendous demand in the U.S. healthcare system for sterile medical technologies, EtO sterilization is already at capacity.”

AdvaMed argued that EPA’s proposal to revise the National Emission Standards for Hazardous Air Pollutants (NESHAP) is “not reasonable and feasible (both economically and technically).” The group said the proposed rule would put additional pressure on manufacturers’ capacity to produce products.

The EPA has also proposed that sterilizers reduce the amount of EtO they use per cycle and revalidate the sterilization cycles, which industry groups said is a time-consuming and costly proposition.

AdvaMed said millions of products would require cycle revalidation, which would require extensive testing and change management submissions that would involve not just the US Food and Drug Administration (FDA) but other global regulators as well. The group said the requirement would result in significant disruption to the medical device supply chain.

“Taking even a handful of facilities offline briefly would cause supply disruptions,” said AdvaMed. “Further, the proposal does not appropriately take into account the time and cost of cycle revalidation that would be necessitated for changes in manufacturers’ FDA regulated sterility assurance processes.”

“AdvaMed members estimate that, if a facility manages to continue operations at all during implementation, sterilization capacity will decrease by at least 30% while the facility is being overhauled,” the group added.

On top of reducing medical device production capacity, the proposed regulations do not take into consideration background levels of EtO and rely on a flawed risk assessment, AdvaMed said. The group also said the proposals take a “one-size-fits-all” approach that treats all medical sterilizers alike.

“It is important to consider that EtO sterilization of medical devices takes many forms,” said AdvaMed. “In the first place, some manufacturers sterilize their own devices in-house, while others contract with commercial sterilizers or other manufacturers. The Proposed Rule therefore affects not only sterilization facilities within the source category, but medical device manufacturers who do not use EtO themselves.”

“In addition, not all sterilization facilities are designed and engineered in the same manner,” the industry group added. “AdvaMed member companies vary in many ways, including with respect to products and packaging, cycle design, equipment, facility design and configurations, process, and geographies.”

AdvaMed also argued that the NESHAP revision rule and the Proposed Interim Registration Review Decision (PID) for EtO based on the Federal Insecticide Fungicide Rodenticide Act (FIFRA) are asking for use of technology that either does not exist or is in limited supply. Also, if the proposals go into effect, sterilizers and manufacturers would have 18 months to implement the changes, which the industry groups said is not feasible.

AdvaMed noted that the two proposed regulations seem to conflict with one another.

“It is absolutely paramount that EPA carefully consider the interplay between the NESHAP Proposed Rule, and the Proposed EtO PID, at least to ensure the two proposals do not contradict,” the group said. “To date, this analysis is lacking from both administrative records, and AdvaMed is concerned that the proposals will contradict or conflict.”

MDMA also commented on EPA’s proposed regulations and asked it to withdraw them. Instead, it asked the agency to work with FDA to repropose EtO standards based on risk to public health based on air emissions balanced against the public’s need to have access to medical devices.

“EPA’s estimated health risks are based on maximum emission levels for hypothetical and unlikely exposure scenarios; permanent and fatal outcomes to actual people can happen in minutes without adequate medical supplies,” said MDMA. “In its reproposal, EPA must quantify both risks in a transparent manner using the best available science.”

MDMA said that if the proposals go into effect, commercial sterilization could drop by up to 51%. The group noted that EPA’s own Regulatory Impact Analysis (RIA) states that medical device suppliers and patients will bear most of the costs of the NESHAP proposal.

“While EPA buries this finding deep in a background document, the reality will be very clear to many consumers who are already skipping necessary health care today due to the rising cost of living,” said MDMA. “EPA’s actions will mean fewer operations, fewer wellness and pediatric checkups, and longer wait times for life-changing procedures.”

“EPA’s proposed actions will also exacerbate inequality in health care access since rising prices will have a disproportionately higher burden on low income, rural, and equity populations,” the group added.

Like AdvaMed, MDMA also argued that EPA doesn’t take into account naturally occurring ambient EtO levels and that available air monitoring data shows emissions of the toxic gas from sterilizing facilities often can’t be distinguished from background levels. In particular, the group pointed to comments from the California-based air quality agency South Coast Air Quality Management District (AQMD) that commercial sterilizers don’t seem to be the source of the ambient levels of EtO that it has measured.

Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules

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