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Cal/OSHA issued 18 citations, including six citations for willful-serious violations, to Parter Medical Products, Inc. for failing to protect its employees from overexposure to ethylene oxide (EtO), a toxic chemical. A willful violation is issued when evidence shows that the employer committed an intentional and knowing violation. The penalties total $838,800 to date, and the status of the ongoing investigation remains “open.”

“Our inspection showed this was not an isolated incident of chemical overexposure to workers,” said Cal/OSHA Chief Jeff Killip. “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 Medical Products, Inc. dba Parter Sterilization Services was founded in 1984, and uses ethylene oxide gas to sterilize medical devices. Chronic exposure to ethylene oxide is associated with cancer, reproductive effects and neurotoxicity. Its odor is undetectable to humans until the concentration exceeds hazardous levels.

On August 5, 2022, Cal/OSHA’s Process Safety Management (PSM) Unit opened an inspection at the Parter facility in Carson. The PSM Unit is responsible for inspecting refineries and chemical plants that handle large quantities of toxic and flammable materials. PSM’s inspection followed an investigation by South Coast Air Quality Management District, which referred the matter to Cal/OSHA.

Parter shut down its facility in August 2022 for several months while it made modifications to reduce outdoor ethylene oxide emissions.

However, Parter’s remediation efforts did not solve the employee-exposure issues indoors. When Cal/OSHA resumed its inspection in December 2022, it found that one employee was overexposed to ethylene oxide his entire shift. Under Cal/OSHA regulations, the permissible exposure limit for eight hours is no more than 1 ppm (parts per million). The employee’s exposure averaged 5 ppm during the shift and averaged 9 ppm during a three-and-a-half-hour period. Tests show Parter employees were exposed to ethylene oxide above the permissible limit from 2019 until 2022.

Cal/OSHA’s citations include violations for the employer’s failure to have an effective safety plan to evaluate and develop controls for hazards, failure to develop a respiratory protection plan as required, failure to monitor employee exposure, and failure to notify workers of exposure over the permissible limit for ethylene oxide.

Parter is located at 17015 Kingsview Avenue in Carson California. The Carson City Council unanimously voted in early 2022 to request air monitors be placed in various locations of the city to monitor air quality.

The City of Carson was advised by South Coast Air Quality Management District (AQMD) that an air pollutant discharge by Parter may constitute a health hazard late in July in the nearby industrial area.

South Coast AQMD has conducted multiple on-site inspections at the facility and conducted field operations in the surrounding area. On July 29, 2022, a Notice of Violation was issued to Parter for Public Nuisance in violation of agency Rule 402 and California Health & Safety Code § 41700. This violation was based on elevated EtO emissions detected through air monitoring efforts outside of the facility at an adjacent business.

South Coast AQMD is further investigating EtO emissions in the nearby residential communities and the agency is working with the City of Carson to identify additional locations to collect 24-hour samples in the nearest community and school. So far, data from residential monitors show EtO levels to be within typical background levels.

Parter had indicated their EtO equipment will remain shut down until additional air pollution controls can be implemented including the modifications and upgrades to air pollution control equipment and temporary enclosures. The facility has initiated the permitting process for the upgrades and South Coast AQMD will review and approve those applications as quickly as possible.

During South Coast AQMD’s monitoring efforts at several commercial EtO sterilization facilities, the agency became aware of fugitive emissions from sources that were not previously known. South Coast AQMD’s investigation has identified that existing pollution controls will need to be upgraded and measures will be needed to reduce fugitive emissions.

South Coast AQMD is working on amending Rule 1405 – Control of Ethylene Oxide and Chlorofluorocarbon Emissions from Sterilization or Fumigation Processes to strengthen requirements to address fugitive emissions, as well as provisions to further reduce EtO emissions from operations at these facilities.