A Carson company that sterilizes medical devices has received 18 citations and civil penalties totaling $838,800 for failing to protect employees from overexposure to the cancer-causing chemical ethylene oxide, state officials announced Tuesday, March 21.
A half-dozen of the citations issued to Parter Sterilization Services are for willful and intentional violations, according to the California Division of Occupational Safety and Health.
“Our inspection showed this was not an isolated incident of chemical overexposure to workers,” Cal/OSHA Chief Jeff Killip said in a statement. “The employer failed to take action to protect employees even after it knew that some of them were exposed to dangerous levels of ethylene oxide.”
Parter officials did not return a phone call seeking comment.
Chronic exposure to ethylene oxide is associated with cancer, reproductive effects and neurotoxicity resulting in damage to the brain or peripheral nervous system. Its odor is undetectable to humans until its concentration exceeds hazardous levels.
More than half of the medical equipment in the United States, or approximately 20 billion devices, is sterilized with ethylene oxide because of the chemical’s ability to penetrate plastics and other materials to destroy bacteria without melting or weakening the device.
The toxicity of ethylene oxide has been debated nationally for decades, but federal regulators have moved at a glacial pace to restrict its use. A draft assessment from the U.S. Environmental Protection Agency in 2006 determined the chemical was significantly more carcinogenic than previously believed, according to ProPublica. Yet, the final assessment wasn’t published until a decade later.
Cal/OSHA’s Process Safety Management Unit, which is responsible for inspecting refineries and chemical plants that handle large quantities of toxic and flammable materials, inspected the Parter facility in August 2022 following an investigation by the South Coast Air Quality Management District.
Parter is within 700 feet of a residential neighborhood and 2,000 feet away from a school. However, information was not immediately available regarding how far the emissions might have traveled.
Although Parter shut down its facility in August 2022 for several months while it made modifications to reduce outdoor ethylene oxide emissions, it did not resolve employee exposure issues indoors, Cal/OSHA said.
When Cal/OSHA resumed its inspection in December 2022, it found that one employee was overexposed to ethylene oxide his entire shift.
Although Cal/OSHA regulations state that the permissible exposure limit for eight hours is no more than 1 part per million, the employee’s exposure averaged 5 ppm during the shift and averaged 9 ppm during a 3 1/2-hour period. Additionally, tests show that Parter employees were exposed to ethylene oxide above the permissible limit from 2019 until 2022, Cal/OSHA said.
Parter also failed to implement effective safety and respiratory protection plans and didn’t monitor employee exposure or notify workers of exposure over the permissible limit for ethylene oxide, according to Cal/OSHA.
Other medical device sterilization companies in Los Angeles County also have faced enforcement from the South Coast Air Quality Management District for emissions of ethylene oxide above mandated thresholds.
Sterigenics, based in Vernon, was ordered in September 2022 to reduce its operations by 20% any time fence-line air monitoring detects ethylene oxide above 17.5 parts per billion, a threshold roughly fives time higher than typically allowed. If the emissions exceed 25 parts per billion in a single day, or stay above 17.5 parts per billion for two days, operations were required to be cut in half.
Sterigenics has complied with the emissions requirements and remains in operation.
Staff writer Jason Henry contributed to this report.
