Fajardo, Puerto Rico (Customed, Inc.)

The Customed Inc. facility located at Carretera Igualdad #7 in Fajardo, Puerto Rico began conducting sterilization activities in 2005. 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 Customed, Inc. 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 Fajardo community. EPA is committed to working with state and local agencies, facilities, and communities to reduce this risk.

Customed, Inc.

This map shows EPA’s estimates of lifetime cancer risks from EtO near Customed, Inc. in Fajardo, 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 10 cancer cases if 10,000 people were exposed for 70 years (or 1,000 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.

• Read additional information on EtO, including information on our current understanding of risks from ethylene oxide.

What EPA is Doing to Address Ethylene Oxide

In March 2024, the U.S. Environmental Protection Agency (EPA) announced it is strengthening 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 Customed Inc.

• Learn more about regulation for EtO Sterilization Facilities.  
• Learn more about EPA’s updated EtO standards.
• For more information about actions you can take.

Community Updates

In May 2024, EPA began a research project in Fajardo to test the effectiveness of different tools that measure EtO emissions and concentrations in ambient air near EtO emitting facilities. To learn more about this research project, see the fact sheets below.

•   EPA scientists evaluate advanced technologies for measuring ethylene oxide in Puerto Rico  (pdf) (706.5 KB)
• Científicos de la EPA evalúan tecnologías avanzadas para medir el óxido de etileno en Puerto Rico (pdf) (705.39 KB)

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.

• June 2024 Community Update for Fajardo, PR (English)
• June 2024 Community Update for Fajardo, PR (Spanish) 

In January 2023, EPA worked with the Puerto Rico Department of Natural and Environmental Resources and local partners to host a community public meeting for the Fajardo community to learn more about EtO and risks from commercial sterilizers.

• January 26, 2023 Community Presentation  [ Fajardo English Presentation (pdf) (6 MB) / Spanish Fajardo Presentation (pdf) (5.3 MB) ]