Background

In the continuing regulatory assault on ethylene oxide, more rules now apply. Fortunately, these latest statutes are not at all difficult to comply with. The new rule is called “National Emission Standards for Hospital Ethylene Oxide Sterilizers.” It was published on 28 December 2007 as 40 CFR Part 63, with particular notice given to subpart WWWWW.

EPA is issuing national emissions standards for new and existing hospital sterilizers that emit hazardous air pollutants and are area sources within the meaning of Clean Air Act section 112(a)(2). The final rule is based on EPA’s determination as to what constitutes the generally available control technology or management practices for the hospital sterilizer area source category.

This action is being finalized as part of EPA’s obligation to regulate area sources listed for regulation pursuant to Clean Air Act section 112(c)(3).

Source Material

Here is a link to the final rule.

Here is a link to subpart WWWWW.

Here is a link to EPA’s summary of the regulations.

Compliance

Our good friends at Honeywell Oxyfume® Sterilants have prepared an explanatory document, with guidelines on how to comply with the new rule. The guidelines would also apply to 100% EtO and cartridge systems.

Honeywell has also prepared an Information Bulletin, that includes a handy table to calculate actual annual ethylene oxide usage, for users of cylinder EtO. A companion document to this is Honeywell’s Example Initial Notification of Compliance Status.

The EPA has determined that Andersen sterilizers are effectively exempt from the rule, since in their method, sterilization bags are utilized, and these bags are always fully loaded—thus comprising “fully loaded sterilization units,” as are required by Subpart WWWWW.

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