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Regulatory Flexibility for Small Entities

Potential SBAR Panel: National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide (EtO) Commercial Sterilization and Fumigation Operations

What is the Implication of the Proposed Action on Small Entities?

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO) Commercial Sterilization and Fumigation Operations were finalized in December 1994 (59 FR 62585). The standards require existing and new major sources to control emissions to the level achievable by the maximum achievable control technology (MACT) and require existing and new area sources to control emissions using generally available control technology (GACT). EPA completed a residual risk and technology review for the NESHAP in 2006 and, at that time, concluded that no revisions to the standards were necessary. In 2016, EPA released its updated unit risk value for EtO, which indicated that cancer risks from EtO were significantly higher than previously understood (see Ethylene Oxide assessment). In 2018, EPA incorporated these values into its National Air Toxics Assessment (NATA), which showed significantly higher cancer risks for areas where commercial sterilizers are located.

Entities potentially impacted by this rulemaking include those who engage in the commercial sterilization of products (e.g., medical devices, pharmaceutical products, spices) with EtO. This rule may consider several emission sources at the facilities, potentially including fugitive emissions (which are currently unregulated), chamber exhaust vents (which were previously regulated but ultimately removed from the existing standards), and other sources that are currently controlled but may be required to increase control efficiency. Lower-usage EtO facilities, some of which are currently unregulated, may have requirements introduced for the first time. Based on initial conversations with regulated entities who have been working to control their emissions, the potential costs associated with these reductions could be significant.

Additional information about the EtO Commercial Sterilization and Fumigation Operations NESHAP is available on EPA’s Ethylene Oxide Emissions Standard web site.

How Can I Learn More?

While the opportunity to participate on this Panel has passed, you will have the chance to submit comments concerning this rulemaking during the standard public comment period commencing after publication of the notice of proposed rulemaking in the Federal Register.

Semiannual updates about the development status of the rulemaking are available on: