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Contract Sterilization Service Provider in California Issued a Notice of Violation for Elevated Levels of Ethylene Oxide
A company in Los Angeles County that provides contract sterilization services to medical device manufacturers was recently issued a Notice of Violation (NOV) for elevated levels of ethylene oxide (EtO) by the South Coast Air Quality Management District (South Coast AQMD). According to the agency, it has an ongoing investigation into emissions of EtO from facilities within its jurisdiction. Air sampling was conducted around the contract sterilization provider's facility and elevated levels of EtO were discovered, prompting more comprehensive air monitoring and further investigation.
Ethylene oxide is an organic compound that is produced in large quantities. It is primarily used as an intermediate in the production of several industrial chemicals, the most notable of which is ethylene glycol. It is both flammable and highly reactive. EtO is also used as a fumigant in certain agricultural products and as a sterilant for medical equipment and supplies.
The U.S. Environmental Protection Agency (EPA) reports:
Exposure to EtO can cause cancer in humans and damage DNA. Other effects of EtO exposure include eye, skin, nose, throat, and lung irritation as well as harm to the brain and nervous system (causing effects such as headaches, memory loss, numbness). Workers in facilities that use EtO and people in communities - including historically underserved communities - located adjacent to these facilities have the highest chance of being exposed to EtO. Additionally, because their bodies are still growing, children are expected to be more susceptible to the toxic effects caused by EtO.
“All the way back in 1987, the state of California designated ethylene oxide as known to cause cancer under Proposition 65,” said Michael Chapman, Laboratory Manager at LA Testing's Huntington Beach facility. “In 2009, that listing was expanded to include reproductive toxicity. Due to exposure concerns, South Coast AQMD continues to pursue actions to minimize EtO emissions from sterilization facilities. To help companies and institutions comply with EtO regulations, the industrial hygiene and environmental scientists at LA Testing offer laboratory testing services for ethylene oxide and many other chemicals. These services protect workers, communities and help to keep companies in regulatory compliance.”
Several years ago, LA Testing sponsored an educational video about ethylene oxide and occupational exposure concerns that can still be seen at: https://youtu.be/_-B8MFnk-ZQ
To learn more about ethylene oxide or other environmental and industrial hygiene testing services, please visit www.LATesting.com, email info@LATesting.com or call (800) 755-1794.
About LA Testing
LA Testing is California's leading laboratory for industrial hygiene and indoor air quality testing of asbestos, mold, lead, VOCs, formaldehyde, soot, char, ash and smoke damage, particulates and other chemicals. In addition, LA Testing offers a full range of air sampling and investigative equipment to professionals and the general public. LA Testing maintains an extensive list of accreditations including: AIHA LAP LLC., AIHA ELLAP, AIHA EMLAP and AIHA IHLAP, CDC ELITE, NVLAP, State of California, State of Hawaii Department of Health and other states. LA Testing, along with the EMSL Analytical, Inc. network, has multiple laboratories throughout California including South Pasadena, Huntington Beach, San Leandro and San Diego.
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