- New draft regulations on ethylene oxide do not appear imminent after an Environmental Protection Agency announcement it will not issue a proposed rule on commercial sterilizers immediately, instead opting to issue an Advance Notice of Proposed Rulemaking and request for information in October.
- Separately, it is unclear how long it will be until a second proposed rule that aims to address air pollution emissions from the ethylene production process is published. An FDA official told MedTech Dive at The MedTech Conference while EPA and FDA are in frequent communication, no formal interagency consultation on EtO regulations has occurred yet. EPA is under court order to issue the rule by March 13, 2020.
- The proposed rule on ethylene production will now likely come out mid-October, but an eventual proposed rule on commercial sterilizers will come out in December or January at the earliest, Greg Crist, AdvaMed's chief advocacy officer, told MedTech Dive.
The dual regulations are a two-pronged approach to tackle emissions of EtO, a carcinogenic gas used to sterilize more than half of medical devices, according to EPA.
But despite several states including Illinois and Georgia have had commercial sterilization facilities close, national regulations setting new standards appear to be months away. The closure of sterilization plants in Willowbrook, Illinois and Atlanta have already caused multi-million dollar losses for major medical device manufacturers like Boston Scientific and Medtronic.
EPA said it has been working to gather information on control technology options and the associated costs as it works to develop its proposed rule on commercial sterilizers. EPA's announcement it plans to take more time to develop the regulations comes a month after AdvaMed met with the White House to lobby on EtO.
Ellen Kondracki, vice president of sustainability & environmental health and safety at BD, noted during a panel at The MedTech Conference that changes in facility design will be key to reduce EtO emissions. EPA said it would also potentially convene a Small Business Advocacy Review Panel before taking "any significant regulatory action."
"Because many commercial stabilizers are small businesses, the EPA is really looking very systematically across the industry at what the new revision for the commercial sterilizers will be," Kondracki said. "Through the work group, we understand the EPA will be actually asking industry for more information around facility design, engineering controls, and costs."
EPA said the October ANPR and RFI will help it collect additional information to support its eventual proposed rule in the coming months. After it issues the proposed rule, the agency said it will seek public comment and hold a public hearing.
"The EPA is going through a full process. So I think to expect anything before Q1 of next calendar year will be aggressive," Dan Carestio, COO of the STERIS Corporation, said during the panel.
FDA communicates with EPA frequently, but no interagency consultation on the forthcoming EtO regulations has occurred to date, Suzanne Schwartz, director of FDA's Office of Strategic Partnerships and Technology Innovation, told MedTech Dive.
"We speak with the federal EPA on a regular basis," Schwartz said. "We've not received anything, nothing has been shared with us."
An FDA advisory committee meeting is scheduled for early November to discuss EtO sterilization of medical devices.
"Worst case scenario, we continue to have this information on a state by state basis that leads state regulators to act differently in different states with respect to how they regulate EtO emissions. That's part of the reason why we've been focused on advocacy at the FDA," AdvaMed CEO Scott Whitaker told reporters at the conference.