Trump Administration Delays Ethylene Oxide Emission Standards by Two Years

The Trump administration has announced a two-year delay in enforcing new Environmental Protection Agency (EPA) regulations aimed at limiting ethylene oxide (EtO) emissions from medical device sterilization facilities. EtO is a known carcinogen, and the EPA’s finalized rule in 2023 intended to reduce emissions by 19 tons annually, limiting exposure to below the lifetime cancer risk threshold of 1 in 10,000. However, the administration argues the rule imposes significant burdens on commercial sterilizers, risking potential facility closures and disruptions in medical equipment supply. Major industry players like BD, Sterigenics, Cosmed Group, and Medtronic will be exempt during this period. Although the EPA under Trump signaled in March that it would reassess these standards, formal changes still require new rulemaking. The medical device industry, represented by AdvaMed, has pushed back, citing a lack of alternatives to EtO for sterilizing many devices. Despite federal delays, some states, like California and Georgia, maintain stricter local emission controls.

21-07-2025