Proposed regulations would have dramatic impact on the healthcare industry

Boise, ID – Attorney General Raúl Labrador joined a coalition of 20 state attorneys general led by Tennessee Attorney General Jonathan Skrmetti in commenting on proposed Environmental Protection Agency (EPA) regulations regarding Ethylene Oxide (EtO) and related emissions standards promulgated under the Clean Air Act (CAA).

EtO is used to sterilize roughly 20 billion medical devices annually and there are no substitutes. Regulating EtO use and emissions could severely negatively impact the medical device supply chain and provision of healthcare in the United States. In a comment letter, the coalition urges the EPA to forgo or defer proposed regulations.

“The Biden administration proposed regulations highlight how one federal agency (EPA) will arbitrarily pursue restricting use of a product, effectively halting supply chains and access, while another (FDA) views the same product as being the only method that effectively sterilizes many medical devices. The EPA rate reduction labeling change of EtO will only decrease domestic market competition, undermine public health, and drive up the cost of healthcare,” Attorney General Labrador said.

The coalition notes the proposed regulations, if adopted, will force the adoption of new, untested technologies to sterilize medical devices. To avoid disruption to healthcare across the country, EPA should forgo the proposed regulations or extend the compliance period.

Attorney General Labrador was joined in signing the letter by state attorneys general from Alabama, Arkansas, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, Utah, Virginia and West Virginia.

Read the letter in its entirety here.