Information About EtO

EPA to issue new rules governing the emissions of ethylene oxide

UPDATE:

The American Contract Systems facility in Temple Terrace (ACS – Temple Terrace) completed the installation of three dry bed scrubbers to reduce air pollution associated with the facility’s medical equipment sterilization activities. These controls are 99.9% effective in reducing ethylene oxide (EtO) levels in the air that is vented from the facility, and these new controls are anticipated to reduce EtO emissions from the facility from approximately 5 pounds per day to less than 0.05 pounds per day. As part of the Florida Department of Environmental Protection’s (DEP) regulatory oversight, the agency conducted an inspection of the ACS – Temple Terrace facility this afternoon, and DEP is overseeing the preliminary testing of the scrubbers to ensure their effectiveness. In the coming weeks, the facility will perform a full stack test using a U.S. Environmental Protection Agency (EPA) approved method, which DEP will also oversee. These new controls reduce the risk well below the threshold that EPA used in modeling risks associated with the ACS – Temple Terrace facility. DEP anticipates that EPA will remodel the risks associated with this facility now that the new controls are operational.

The Florida Department of Environmental Protection has indicated that the American Contract Systems permit included the installation of three scrubbers.

The most recent inspection report is available online.

Background:

On Friday, June 9, 2023, the City of Temple Terrace was advised by the federal Environmental Protection Agency (EPA) that the EPA was seeking to implement new rules governing the emissions of ethylene oxide (EtO) at American Contracts Systems (ACS), a medical and dental equipment sterilization facility, located in our community at 7802 East Telecom Parkway.

Local residents affected

According to the EPA, ACS is in compliance with its current regulations, however the Agency recently determined that this facility’s EtO emissions may pose an elevated risk for certain cancers both for those in the facility and those living and working within a geographic radius around the site. More information is available here. Under the EPA’s model, the risk for certain cancers from American Contract Systems’ EtO emissions was calculated to be between 100 to 4,000 per million. The EPA considers a risk of over 100 per million to be elevated and, therefore, is seeking to implement new, more stringent regulations.

EPA outreach

The EPA hosted two informational webinars on June 13 to discuss this matter and gather public comment. City officials were in the audience for both sessions. At those sessions, a representative of the State of Florida’s Department of Environmental Protection (FLDEP) stated that American Contract Systems had already secured permits to install controls to address over 90% of their EtO emissions. According to the FLDEP, these controls are expected to be in place within the next one to two months.

City response

The City of Temple Terrace began a dialog with County and State Environmental Protection officials on June 14 at which time the City appealed to the State to exercise its full authority to hold ACS accountable in installing the emission controls within the timeframe noted. At City’s request, Mayor Andy Ross and City Manager Carlos Baía participated in a follow up meeting with representatives of ACS, Baycare (the ACS building owner), and staff from Environmental Protection Commission Florida Department of Environmental Protection on June 19. During this meeting, ACS committed to implementing controls that will eliminate 99.97% of their current EtO emissions from the facility by July 31.

American Contract Systems Statement

Over the past few years, DEP has assisted EPA in collecting emissions data for Florida’s six commercial sterilization facilities, including ACS – Temple Terrace, as EPA conducted a nationwide analysis of EtO emissions. As part of this information collecting process, DEP also conducted inspections at the facility to better understand facility operations and emission controls. These were in addition to DEP’s routine compliance inspections.

DEP is aware that EPA intends to move forward with rulemaking to strengthen emission standards for EtO and that it will impact facilities throughout the U.S., including ACS – Temple Terrace.

In advance of this rulemaking effort, ACS – Temple Terrace voluntarily installed new emissions controls for EtO at the facility that reduce the risk well below the threshold used in EPA’s modeling. With these new controls installed and operational, DEP anticipates that EPA will remodel this facility to confirm the reduced risk to the community.

ACS – Temple Terrace and the five other Florida facilities have met and continue to meet all current federal air emissions standards and are in compliance with all conditions of their respective air operation permits.

DEP is committed to protecting Florida’s air quality and looks forward to participating in the upcoming rulemaking effort. 

More information

Information about EtO and the EPA’s proposed rule can be found at here on the EPA's website.