The Environmental Protection Agency plans to reconsider emissions standards for facilities that sterilize medical devices as part of a broader deregulatory agenda announced on Wednesday.
The EPA did not immediately respond to MedTech Dive’s request for comment on what changes the agency plans to make as it reviews the standards. The Trump administration is considering a two-year compliance exemption for affected facilities while the EPA goes through the rulemaking process, the agency said in the announcement.
Last year, the EPA released a final rule limiting emissions of ethylene oxide, a carcinogenic chemical used to sterilize about half of medical devices in the U.S. The changes were intended to reduce EtO emissions from commercial sterilizers by more than 90%. They would also ensure that no one would be exposed to levels of the chemical that could lead to a lifetime cancer risk of more than 1 in 10,000 people, the upper bound of what the EPA considers acceptable.
The medtech industry initially pushed back against the requirements, saying they could reduce capacity for sterilizing medical devices, potentially leading to shortages. As a result, the EPA gave medtech companies two years to comply with the new emissions limits.
The Trump administration could overturn or revise the final rule by proposing new regulations, which typically involve a notice and a public comment period.
