This article has been updated with a comment from AdvaMed.
The U.S. Environmental Protection Agency will require medtech sterilization companies to provide information to help it formulate a new rule governing emissions of ethylene oxide.
The EPA recently said that in October, it will ask for data on specific sterilization facility characteristics, control devices, work practices and costs associated with installation and operation of emission-reduction measures. The request is part of an advance notice of rulemaking, in which the agency will outline its potential options, describe EO emission-controls technologies and seek public input and additional data and information. The agency is under court order to produce a new rule by March 2020.
EO is a colorless, odorless gas used to sterilize millions of medical devices annually. The EPA declared it carcinogenic in 2016. State officials in Illinois and Georgia have taken steps this year to require two companies that operate EO plants to reduce emissions, including closing a Sterigenics plant in Willowbrook, Ill. Last week, the Illinois EPA issued a permit to Sterigenics begin installing emissions-control technology at that plant.
The federal EPA said recently that it has been working over the past year to compile information on control technology options and costs for the more than 100 sterilizers that the rule would potentially cover.
Because nearly one-third of the sterilizers potentially affected by the rule are small businesses, the EPA said it may need to convene a small business advocacy review panel before taking any significant regulatory action. The agency said it will soon request nominations for small-business representatives for that panel.
The agency will issue the new proposed rule for ethylene oxide commercial sterilizers in the coming months, seek public comments on it an hold a public hearing.
AdvaMed estimates the earliest that the new rules may come out is in December or January, according to Greg Crist, the trade group’s head of government affairs.
