EPA starts the clock on new EtO sterilization emissions rule

Commercial sterilization facilities will have two to three years to comply with a new ethylene oxide (also referred to as EtO or EO) sterilization emission rule announced by the EPA today.

However, the EPA said it will not require commercial sterilizers to use lower concentrations of EtO or to limit the use of packaging and pallet material, citing industry feedback.

Addressing the potential for medical device shortages if sterilizers are unable or unwilling to comply, the agency’s final rule also includes presidential authority for two-year exemptions for stationary sterilizers if the commander-in-chief “determines that the technology to implement such standard is not available and that it is in the national security interests of the United States to do so.”

The EPA’s previous proposal would have only allowed 18 months for compliance.

The EPA said the new EtO sterilization limits and air pollution control requirements will …

Read more
  • 0