The EPA is no longer planning to propose toxic air pollution limits for carcinogenic ethylene oxide releases from medical sterilizer facilities this summer, as promised earlier.
Instead, the Environmental Protection Agency quietly announced Sept. 13 it would take a series of steps that will delay any action until later, including the release of an advanced notice of proposed rulemaking next month. This notice, on which the agency will take public comment, will “outline the potential approaches that EPA could take in its upcoming rule, along with the technologies available for controlling ethylene oxide emissions.”
The agency said it plans to issue the actual proposed rule “in the coming months,” according to a separate statement.
The EPA said it also would invoke its Clean Air Act authority to require companies to provide data on specific facility characteristics, control devices, work practices, and costs associated with installation and operation of emission reduction measures.
Because a third of the companies that use ethylene oxide to sterilize medical equipment—and EPA estimates there are more than 100 such facilities nationwide—are considered small businesses, EPA said it also may convene a small business advisory panel to review its actions.
The agency said it needs this additional information to ensure “we have a solid data-based record to support rulemaking.”
It is “not uncommon or particularly unusual” for the EPA to issue an advanced notice or ask companies for data, Stan Meiburg, who served as EPA’s acting deputy administrator during part of the Obama administration, told Bloomberg Environment.
“Even though ethylene oxide has received a lot of attention lately, there are many useful pieces of information that the data will reveal to the agency,” Meiburg said.
For instance, states are taking a lot of actions on their own, he said; One of the advantages for the EPA to gather this data is to get a clear handle on what is going on in the industry and states.
Given though it is the middle of September, “the likelihood the EPA will issue a notice of proposed rulemaking before the end of this year seems slim, Meiburg said.
‘Lack of Urgency’
The EPA has been promising for months to release a proposal to tighten ethylene oxide emissions limits from medical sterilizer facilities, which have remained unchanged since they were set in 1994 and modified in 2001.
But its decision to seek an advanced notice of proposed rulemaking delays the actual proposal for revised toxic air limits for ethylene oxide, a flammable, combustible gas that the EPA says increases cancer risks.
Ethylene oxide emissions have garnered attention across the country, including in Illinois and Georgia, especially since the agency’s own researchers concluded in late 2016 that ethylene oxide is at least 30 times more carcinogenic than previously understood.
Since then, communities where commercial medical sterilizers use this toxic chemical have been waiting for the EPA to act, while stepping up the pressure on their own state governments.
A group calling itself “Stop Sterigenics Georgia,” which has been trying to halt the operations of the Sterigenics U.S. LLC medical sterilizer facility in Cobb County in the greater Atlanta area, said it was disappointed with the EPA’s decision.
“We understand the slow-moving nature of government agencies and our organization will participate in the public comment process,” Janet Rau, president of Stop Sterigenics Georgia, said in a text message late Sept. 13. “We are, however, disappointed in the lack of urgency by the EPA as we believe that any more delays in recognizing the danger of ethylene oxide are continuing to put our communities at risk.”