EPA Finalizes Clean Air Act Standards for Ethylene Oxide Emissions from Commercial Sterilizers

The U.S. Environmental Protection Agency (EPA) recently finalized amendments to Clean Air Act standards for ethylene oxide emissions from commercial sterilization facilities, a crucial step in ensuring public health and safety. This rule applies specifically to facilities that sterilize medical products, as well as other industries such as spice and food processing.

What are the final amendments to Clean Air Act standards for ethylene oxide emissions from commercial sterilization facilities?

The EPA has finalized amendments to Clean Air Act standards for ethylene oxide (EtO) emitted from commercial sterilization facilities, specifically applying to medical product sterilizers as well as spice, extract, dried food, and dehydrated food sterilizers. The rule aims to reduce EtO emissions by implementing emission limits and monitoring requirements for commercial sterilizers.

What are the strict reductions in EtO emissions required by the final rule?

The final rule requires strict reductions in EtO emissions from sterilization chamber vents, aeration room vents, chamber exhaust vents, and Group 1 and Group 2 air emissions through percent reduction standards.

What is the combination of mass emission rate and percent reduction standards in the proposed rule?

The proposed rule featured a combination of mass emission rate and percent reduction standards. However, the finalized Clean Air Act standards for ethylene oxide emissions from commercial sterilizers differ from this proposal.

Why did the EPA require a Permanent Total Enclosure (PTE) for Group 1 and 2 emissions to operate within?

The EPA required a Permanent Total Enclosure (PTE) for Group 1 and 2 emissions to operate within so that all emissions can be collected and routed to a control device, ensuring effective capture and reduction of ethylene oxide emissions from commercial sterilizers.

What is the initial performance test requirement for facilities that use over 100 pounds per year of ethylene oxide?

The initial performance test must consist of the first 30 operating days after the certification of the Continuous Emission Monitoring System (CEMS) according to Performance Specification (PS) 19.

Is traditional stack testing a viable option for demonstrating initial compliance for facilities that use less than 100 pounds per year of ethylene oxide?

Yes, according to the EPA regulations, traditional stack testing is a viable option for demonstrating initial compliance for facilities that use less than 100 pounds per year of ethylene oxide.

What are traditional stack testing methods used to demonstrate compliance with Clean Air Act standards?

EPA Methods 1, 2, 3, and 320 are traditional stack testing methods used to demonstrate compliance with Clean Air Act standards.

Is time-sharing an instrument allowed for CEMS among different measurement points?

Yes, according to the rule, a facility may time-share a Continuous Emissions Monitoring System (CEMS) among different measurement points provided that certain requirements are met.

What is the option for determining the inlet of SCV's where control device inlet monitoring is not required?

The option for determining the inlet of Sterilization Cycle Validation (SCV)’s is to measure or calculate the mass of Ethylene Oxide (EtO) charged to the chamber.

What is the measurement interval between CEMS points?

The sampling time at each measurement point is at least 3 times as long as the CEMS response time.

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