Añasco, Puerto Rico (Edwards Lifesciences)
Edwards Lifesciences is located at Parque Industrial Carr. PR-402, Km. 1.4 N, Añasco, 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 Edwards Lifesciences 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 Añasco community. EPA is committed to working with state and local agencies, facilities, and communities to reduce this risk.
Edwards Lifesciences
This map shows EPA’s estimates of lifetime cancer risks from EtO near Edwards Lifesciences Technology Sàrl in Añasco, 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 50 cancer cases if 10,000 people were exposed for 70 years (or 5,000 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 Edwards facility began operations in 1972 and has been conducting sterilization activities since 1989. Edwards manufactures medical devices, including catheters for newborn/premature babies. Edwards uses EtO to sterilize their own product and product from external clients.
In late June 2022, the facility completed the construction and installation of new control devices. The facility reconfigured their EtO treatment process by installing a new wet scrubber and a dry bed reactor to remove EtO from sterilization chambers, and installed dry bed reactors in series to treat the emissions from the aeration rooms, sterilization chambers back vents and warehouse emissions. The facility also conveyed all emission sources into a single stack and increased the height of the stack. The facility aims to achieve at least 99.99% EtO emission reduction efficiency with the implementation of their new EtO treatment configuration. On July 28-29, 2022, the facility conducted the required performance testing that will determine if this goal was achieved. If everything goes as planned, the facility expects to have the new treatment configuration in operation by the end of September 2022. EPA will update this page when we are able to verify the results of the performance testing and that the new configuration is operational.
What EPA is Doing to Address Ethylene Oxide
To protect the public and the environment, EPA creates and enforces the rules according to a variety of environmental laws and regulations. The Federal Clean Air Act (CAA) regulates toxic substances in the air and EtO is classified as a toxic substance in the air. EPA is evaluating the CAA regulations for facilities that emit EtO, including standards for air emissions in commercial sterilizers such as the one located at the Edwards Lifesciences facility in Añasco
EPA hosted an information session on Wednesday, June 23, 2021 at the Luis Muñoz Marin High School in Añasco which included an open table session with representatives from EPA, DNER, the Municipality of Añasco, and Edwards Lifesciences. EPA and DNER presented details about EtO emissions in the community, their potential health risks, and immediate actions been taken by the agencies and the facility followed by a question and answer session. Materials from this information session are available below:
- EPA R2 Air and Radiation Division Presentation from June 2021 Public Session (English and Spanish) (pdf)
- EPA R2 Caribbean Environmental Protection Division Presentation from June 2021 Public Session (Spanish) (pdf)
- June 2021 Factsheet (Spanish) (pdf)
Now: EPA is working with the Puerto Rico’s Department of Natural and Environmental Resources (DNER) to reduce emissions at the Edwards facility. EPA has provided technical support to our air agency partners as part of this work. The facility has shown commitment to keep EPA, DNER and the community informed about their operations and the outcome of their EtO emissions reduction project. 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.