Añasco, Puerto Rico (Edwards Lifesciences)
Edwards Lifesciences (Edwards) is located at Parque Industrial Carr. PR-402, Km. 1.4 N, Añasco, PR. 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 ethylene oxide (EtO) to sterilize their own product and product from external clients.
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.
What EPA is Doing to Address Ethylene Oxide
In March 2024, the U.S. Environmental Protection Agency (EPA) strengthened Clean Air Act (CAA) standards for ethylene oxide (EtO) emissions from commercial sterilization facilities. To protect the public and the environment, EPA creates and enforces the rules according to a variety of environmental laws and regulations. The CAA regulates toxic substances in the air and EtO is classified as a toxic substance in the air.
EPA and the Puerto Rico Department of Natural and Environmental Resources (DNER) are committed to working together to reduce emissions at Edwards Lifesciences.
- Learn more about EPA’s updated EtO standards.
- Learn more about regulation for EtO Sterilization Facilities.
- For more information about actions you can take.
Community Updates
In March 2024, EPA strengthened Clean Air Act (CAA) standards for EtO emissions from commercial sterilizers. Community updates on the Añasco facility and the updated standards are below.
- June 2024 Community Update for Añasco, PR (pdf)
- SPANISH June 2024 Community Update for Anansco, PR (pdf)
- SPANISH Anasco, PR EtO Final Rulemaking Fact Sheet (pdf)
- Overview of Final Air Toxics Rule for EtO Sterilization Facilities
In June 2021, EPA hosted an information session 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
- EPA R2 Caribbean Environmental Protection Division Presentation from June 2021 Public Session
- June 2021 Factsheet (Spanish)