Trump Extends Compliance Deadlines for Ethylene Oxide Regulations

President Donald Trump has issued an executive order extending compliance deadlines for medical device sterilization facilities regarding the use of ethylene oxide (EtO). This decision grants a two-year reprieve from new emissions limits set by the U.S. Environmental Protection Agency (EPA), impacting 39 facilities that utilize this chemical for sterilizing medical devices.

Ethylene oxide is a vital agent in the sterilization process for many medical devices, but it carries significant health risks. The chemical has been linked to mutagenic effects, which can lead to genetic alterations and potentially cancer. Concerns over its safety have resulted in a gradual decline in its use across Europe, largely due to stringent regulatory measures.

The executive order cites two main reasons for the extension: the assertion that commercially viable emissions-control technology is unavailable and the claim that the exemption serves the national security interests of the United States. The order leverages section 112(i)(4) of the Clean Air Act, which allows the President to grant compliance exemptions under specific circumstances.

In March 2024, the EPA had finalized a rule aiming to reduce EtO emissions by over 90% through the implementation of air pollution controls. This rule affects approximately 90 commercial sterilization facilities operated by around 50 companies across the country, setting rigorous standards for building leaks, chamber exhaust vents, and continuous emissions monitoring.

The recent decision to extend compliance deadlines has drawn mixed reactions. Medical device trade groups have been lobbying for this change, citing potential disruptions to the supply chain and challenges in implementation. They argue that ethylene oxide may be the only viable sterilization method for certain medical devices, as alternative methods could damage these products.

Despite the extension, the facilities will still be subject to the emissions and compliance obligations that were in effect prior to the updated EPA rule. This means that while they have more time to meet the new standards, they must continue to operate within the framework of existing regulations.

Internationally recognized standards, such as ISO 10993-7 and ISO 11135, dictate the acceptable levels of residual ethylene oxide in sterilized medical devices. The recent U.S. policy shift raises questions about the country’s alignment with these international standards, as many health regulators, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), have expressed concerns about the risks posed by EtO residues.

Inhalation of ethylene oxide can lead to various health issues, including respiratory irritation, headaches, and, in severe cases, lung damage. The chemical can also be absorbed through the skin, resulting in significant health complications. As a result of these risks, there is ongoing debate about the suitability of EtO as a sterilant, with many experts advocating for safer alternatives such as gamma radiation.

The extension of compliance deadlines underscores a complex intersection of public health, industry needs, and regulatory frameworks. As the landscape of medical device sterilization continues to evolve, stakeholders will need to navigate these challenges carefully to ensure both safety and supply stability.