Trump gives device sterilizers two more years to comply with EtO limits

President Donald Trump issued an executive order (EO) last week granting a two-year extension for medical device sterilization facilities to comply with the new limits for ethylene oxide (EtO) for device sterilization. The action was taken to avert potential device shortages and reflects a belief within the administration that the technology needed to cut emissions to the required levels is not widely available.

Last year, the Environmental Protection Agency (EPA) issued a final rule to limit emissions of EtO, which are deemed carcinogenic. The rule gave facilities two years to comply with new EtO limits and were to go into effect in April 2026. (RELATED: EPA finalizes rule to reduce EtO emissions from sterilization facilities, Regulatory Focus 14 March 2024).

AdvaMed President Scott Whitaker was critical of the EPA rule. In comments about the proposed rule in 2023, he said that EPA did not give sterilizers enough time to comply. He further asserted that the EPA rule appeared to “overstate the risk” of the danger posed by EtO.

During a meeting of the Food and Drug Law Institute (FDLI) last year, a US Food and Drug Administration (FDA) official stated that the EPA limits could pose risks to rural and vulnerable populations. (RELATED: FDA concerned about potential device shortages due to new EtO limits, Regulatory Focus 20 May 2024).

In a shift from the previous administration, the Trump administration issued an executive order stating that the new rulemaking imposes significant burdens on commercial sterilization facilities and could lead to shortages of essential sterile medical devices.

It noted that about 50% of all sterile medical devices in the US are sterilized with EtO, which may be the only method of sterilizing many medical devices without damaging them. Trump further announced that enforcing the EPA limits would “undermine our national security.”

The EO further noted that “the technology to implement the EtO Rule is not available. Such technology does not exist in a commercially viable form sufficient to allow implementation of and compliance with the EtO Rule by the compliance dates set forth in the EtO Rule.”

Annex I of the order lists 39 medical device facilities that will be exempt from the rule for two years.

The rule covers facilities that sterilize medical devices, including fiberoptic endoscopes, specula, surgical kits, syringes, sutures, catheters, IV sets, plastic tubing, and inhalation therapy supplies.

In a statement, Becton Dickson, a medical device sterilizer with several facilities listed in the order, expressed support for the two-year extension.

“BD is committed to complying with the new NESHAP [National Emission Standards for Hazardous Air Pollutants] requirements, however, some of the new provisions require new equipment that is manufactured by a limited number of manufacturers and may not be available in time to install and test before the original April 2026 deadline. The recently announced exemption will ensure there is a more realistic timeframe to comply with the new requirements.”

The company further stated that in 2022, following several years of air monitoring, the Georgia Environmental Protection Division found the levels of ethylene oxide (EtO) measured near BD’s Covington facilities were generally similar to the concentrations recorded at background sites without known commercial sources of EtO. This included a state park located 200 miles away.

Executive order

Trump gives device sterilizers two more years to comply with EtO limits

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