On March 14, the Environmental Protection Agency (EPA) released its update to the National Emission Standards for Hazardous Air Pollutants (NESHAP) final rule for ethylene oxide (EtO) commercial sterilization facilities. EtO is used to sterilize approximately 20 billion, or 50%, of all medical devices in the U.S. each year. According to the EPA’s fact sheet, the “rule will reduce EtO emissions by over 90 percent, reducing cancer risk in dozens of communities nationwide,” and “will enable cost-effective compliance, mitigating and managing any potential risks to the supply chain.” Commercial sterilizers of medical devices will now have at least two years to meet the new emissions limits.
Amendments to the NESHAP: The EPA is finalizing the following amendments to the NESHAP:
- Establish standards for currently unregulated emissions, such as building leaks (“room air emissions”) and chamber exhaust vents,…
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