Villalba, Puerto Rico (Medtronic PR Operation Co.)
Medtronic PR Operation Co. is located at Carretera 151, Bo. Villalba Arriba, Villalba, PR. The facility uses ethylene oxide (EtO) to sterilize medical equipment and materials.
EPA scientists and analysts recently completed a risk assessment to understand the impact of EtO emissions from the Medtronic PR Operation Co. facility. As part of this risk assessment, we used the most recent available information about how much EtO the company emits into the air and we modeled estimated cancer risks to people living nearby. The risk assessment identified elevated cancer risk in the Villalba community. EPA is committed to working with state and local agencies, facilities, and communities to reduce this risk.
Medtronic PR Operation Co.
This map shows EPA’s estimates of lifetime cancer risks from EtO near Medtronic PR Operation Co. in Villalba, PR. As you can see from the map risk decreases with distance from the facility.
The area in blue shows estimated lifetime cancer risks of 100 in a million or greater from breathing air containing EtO emitted from the facility (or the same as 1 additional cancer case in 10,000 people). A lifetime cancer risk of 100 in a million means that, if 1 million people were exposed to this level of EtO in the air 24 hours a day for 70 years, 100 people would be expected to develop cancer from that exposure.
The area in dark blue on the map shows that EtO exposure could contribute to a maximum increased risk level of 8 cancer cases if 10,000 people were exposed for 70 years (or 800 in 1 million). EPA cannot predict whether an individual person will develop cancer.
View a larger version of the map and legend in a new browser tab.
For this risk assessment, we looked at excess cancer risk attributable to a single chemical, EtO. This estimated risk is in addition to the risk of developing cancer from other causes. This is a worst-case scenario that assumes a person stays in the highest risk area 24 hours a day continuously for 70 years. EPA takes this approach because we want to be protective of the most exposed and most vulnerable individuals from risk associated with EtO emissions from this facility.
Community and Facility Details
The Medtronic facility located at Carretera 151, Bo. Villalba Arriba in Villalba, PR opened in 1974 and has been conducting sterilization activities since 1998. The facility sterilizes medical devices manufactured on-site including leads and catheters used in pacemakers and pumps used for the treatment of Parkinson’s disease.
EPA is working with the Puerto Rico Department of Natural and Environmental Resources and local partners to host a community public meeting on January 24, 2023 for the Villalba community to learn more about EtO and risks from commercial sterilizers.
What EPA is Doing to Address Ethylene Oxide
Now: EPA and the Puerto Rico’s Department of Natural and Environmental Resources (DNER) are committed to work together to facilitate and expedite any effort to reduce emissions at Medtronic PR Operations Co. The facility is planning to install further EtO emission controls in addition to their current emissions control configuration. The project will increase the facility’s EtO emission reduction efficiency and will add controls to the aeration phase of their sterilization cycle. EPA issued a Notice of Violation (NOV) on July 29, 2021, citing non-compliance with NESHAP Subpart O reporting requirements. EPA and the facility are currently having discussions to resolve the compliance issue cited in the NOV. The facility has shown willingness and commitment to invest in improvements to reduce their emissions and to provide as much information as possible to keep the community informed about these improvements. The Agency is reviewing controls on regulated equipment and processes that emit EtO to determine whether additional air pollution controls are needed. This review includes examining new developments in practices, processes and control technologies, considering cost and feasibility, as well as addressing any previously unregulated emission points.
Soon: Later this year, EPA will propose strengthening current regulations for Ethylene Oxide Commercial Sterilizers. EPA will consider risk as part of the proposed regulations.
- Learn more about regulation for EtO Sterilization Facilities.
- For more information about actions you can take.
Community Updates
EPA worked with the Puerto Rico Department of Natural and Environmental Resources and local partners to host a community public meeting on January 24, 2023 for the Villalba community to learn more about EtO and risks from commercial sterilizers.
- January 24, 2023 Community Presentation
Villalba English Presentation (pdf)
Spanish Villalba Presentation (pdf)