FAQ: New EPA rules for EO emissions from hospital sterilizers
| Q: |
What is the new regulation from the EPA related to ethylene oxide sterilization? |
| A: |
At the end of 2007, the U.S. EPA issued a final rule regulating emissions from hospital EO sterilizers. EO is considered a hazardous air pollutant (HAP) under the provisions of the Clean Air Act. The EPA regulates area sources of HAPs, and hospitals are considered possible area sources of EO emissions.
Under the new final rule, hospitals running EO cycles without an air pollutions control device must sterilize full loads of items having common aeration time, except when running a partial load is medically necessary. The EPA recognizes that the practice of running full loads is being done at most facilities already. The use of an air pollution control device (e.g. 3M™ EO Abator) is an acceptable alternative to running full loads. |
| Q: |
What do I need to do to comply with the new standard? |
| A: |
If your hospital has an EO sterilizer without an air pollution control device, you must:
- Submit an Initial Notification of Compliance Status letter including the following: the name and address of your facility, the physical location of EO sterilizer, a description of EO sterilization done at your facility (such as typical number of sterilization cycles/year, etc.) and statment that your facility will adhere to running full loads.
- Record the date and time of each EO sterilization cycle.
- Note any EO sterilization cycles that were not full loads, including a statement from a hospital CS staff member, hospital administrator, or a physician, that it was medically necessary.
If your hospital has an air pollution control device and is subject to state or local regulations, you must:
- Submit an Initial Notification of Compliance Status letter stating that you are operating the sterilizer in accordance with your state or local regulations and following the control device manufacturer's recommended procedures.
If your hospital has an air pollution control device, but is not subject to state or local regulations, you must:
- Submit an Initial Notification of Compliance Status letter stating that you are venting the EO emissions from each sterilizer to an add-on air pollution control device and that this device is operating during all sterilization processes and in accordance with the manufacturer's recommended procedures.
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| Q: |
Where can I find the Initial Notification of Compliance Status (INOCS) form? |
| A: |
The EPA has developed an example INOCS form for use by hospitals. This example form is attached below or it can be found at http://www.epa.gov/ttn/atw/area/arearules.html#current.
To access the sample Hospital EO Sterilizer INOCS form on the website, scroll down to "Initial Notification Examples". Click on the PDF document entitled: Example of initial notification of Compliance Status for 40 CFR 63, subpart WWWWW:National Emission Standards for Hospital Ethylene Oxide Sterilization. Note that Line 4 of the form asks about the total annual facility usage of EO, in pounds. For users of 3MTM Steri-VacTM Gas Sterilizers, simply multiply the number of Steri-GasTM cartridges used per year by the weight of ethylene oxide in each cartridge (100 grams in 4-100 cartridges and 170 grams in 8-170 cartridges) to calculate total annual usage in grams. Divide this number by 454 to arrive at your annual usage in pounds. The example form includes instructions on submitting the completed INOCS form.
The EPA has also published a helpful trifold brochure summarizing the Hospital Sterilizer EO Emission regulation. It can be found at http://www.epa.gov/ttn/atw/area/sterilizersb.pdf. This brochure includes the addresses of Regional EPA offices and a link to the delegated state agencies.
INOCS example form
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Use the link below to view the complete standard on the EPA's Web site.
http://www.epa.gov/fedrgstr/EPA-AIR/2007/December/Day-28/a25233.pdf
Use the link below to download the full 3M™ Attest™ Sterile U Tutorial summarizing the new EPA National Emission Standard for Hospital Ethylene Oxide Sterilizers.
3M™ Attest™ Sterile U Tutorial (PDF, 2.21MB)
