EHS Administration, Enforcement and Inspection

Sterilization Company Faces $838,800 Cal/OSHA Fine

Parter Medical Products, Inc., of Carson, California, failed to protect its employees from overexposure to ethylene oxide (EtO), a toxic chemical, according to the California Division of Occupational Safety and Health (Cal/OSHA), prompting the agency to issue 18 citations, including 6 citations for willful, serious violations. Penalties total $838,800, the state agency announced March 21.

Cal/OSHA issues willful violations when it finds evidence that an employer committed an intentional and knowing violation.

The agency’s Process Safety Management (PSM) Unit, which is responsible for inspecting refineries and chemical plants that handle large quantities of toxic and flammable materials, opened an inspection at the Parter facility on August 5, 2022.  

The PSM Unit’s inspection followed an investigation by the South Coast Air Quality Management District (AQMD), which referred the matter to Cal/OSHA. Air sampling discovered elevated levels of EtO around the facility, which is 700 feet from the nearest residential area and about 2,000 feet from the nearest elementary school, according to the South Coast AQMD.

Parter Medical Products, Inc., doing business as Parter Sterilization Services, uses EtO gas to sterilize medical devices, according to Cal/OSHA. Chronic exposure to EtO is associated with cancer, neurotoxicity, and reproductive effects, and its odor is undetectable to humans until the concentration exceeds hazardous levels, according to the agency.

Parter’s Carson operations run 24 hours a day, 7 days a week, according to the South Coast AQMD.

“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 shut down its facility in August 2022 for several months while it made modifications to reduce outdoor EtO emissions. However, Parter’s remediation efforts did not solve the employee exposure issues indoors, according to Cal/OSHA.

When the agency resumed its inspection in December 2022, it found that one employee was overexposed to EtO for an entire shift. Under Cal/OSHA regulations, the permissible exposure limit (PEL) for 8 hours is no more than 1 part per million (ppm), the same as the federal Occupational Safety and Health Administration’s standard for EtO. The employee’s exposure averaged 5 ppm during the shift and averaged 9 ppm during a 3 ½-hour period. Tests showed that Parter’s employees were exposed to EtO above the permissible limit from 2019 until 2022.

Cal/OSHA cited the employer for violations that included:

  • Failure to have an effective safety plan to evaluate and develop controls for workplace hazards;
  • Failure to develop a respiratory protection plan, as required;
  • Failure to monitor employee exposures; and
  • Failure to notify workers of exposures over the permissible limit for EtO.  

California operates a state safety and health plan that’s authorized by federal OSHA. Cal/OSHA, a division with the state Department of Industrial Relations, helps protect workers from health and safety hazards in private sector and state and local government workplaces.

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