The South Coast Air Quality Management District designated Sterigenics in Vernon as a “potentially high risk” facility this week and will require the company to immediately reduce carcinogenic emissions from its medical device sterilization work.
At the same time, California’s workforce safety regulator, Cal/OSHA, has launched its own investigation into the company over concerns for the employees.
The AQMD began investigating Sterigenics, which uses a carcinogenic gas called ethylene oxide to sterilize medical equipment, in March following increased scrutiny of such companies at the national level. Ethylene oxide is a flammable, colorless gas — also used in antifreeze — that may cause headaches, nausea or vomiting in the short term. Long-term exposure over a number of years could lead to lymphoid and breast cancers.
AQMD first issued a notice of violation against Sterigenics in early May for failure to operate and maintain its air pollution control system.
‘Reduce emissions’ ASAP
Under California law, a facility can be designated “potentially high risk” if emissions could exceed a “cancer risk threshold greater than 100 chances in a million.” The AQMD’s initial data indicated workers at adjacent facilities, if exposed for years, could have a cancer risk as much as 20 times higher. The concentrations of ethylene oxide detected near Sterigenics dropped off significantly within a few hundred feet of the facility and were “within background levels” in the closest neighborhood, according to AQMD.
“Given the significant levels of ethylene oxide emitted by your facility, we strongly encourage you to take all necessary steps to reduce these emissions as quickly as possible,” wrote Ian MacMillan, the AQMD’s assistant deputy executive officer, in a letter to the company.
The new designation requires Sterigenics to provide a report within 90 days detailing the actions the company will take in the short term, including the potential scaling back of its operations. In May, Los Angeles County Supervisor Janice Hahn, whose district includes Vernon, called for the temporary shuttering of the facility until the emissions are brought to a safe level and expressed disappointment when the AQMD did not do that.
Workplace safety
While AQMD has authority over outdoor air quality, Cal/OSHA is responsible for enforcing state laws that protect Sterigenics’ employees. Cal/OSHA conducted an unannounced inspection of Sterigenics’ facilities May 27 and now has an open investigation into the company, according to its website. No citations have been issued, but the state regulator has up to six months to make its determination.
In June 2019, Cal/OSHA cited Sterigenics’ facilities in Ontario for employees not using personal protective equipment, a lack of written safety information for processing hazardous materials, and for not having a safety review prior to using hazardous materials. The company paid a $900 fine.
In November, ProPublica released an analysis of more than 1,000 toxic “hot spots” across the country. The Sterigenics facilities in Vernon and Ontario made the list.
Cal/OSHA would not disclose the complaint that prompted its recent inspection of the Vernon facilities; however, it likely resulted from information provided by the AQMD. The Air Quality Management District reached out in early May and staff from the enforcement divisions of the two agencies have met and spoken by phone multiple times in the months since. Most recently, executives from both agencies met June 3 to discuss Sterigenics, according to Nahal Mogharabi, AQMD’s spokesperson.
Two days earlier, the AQMD ordered Sterigenics to turn over roughly six months of data from an internal alert system that detects ethylene oxide levels and warns workers when conditions become unsafe. In an email, Mogharabi said AQMD is aware of the warning lights triggering inside the buildings.
The AQMD also is working with the Los Angeles County Department of Public Health on additional risk assessments, according to a press release.
‘Remediation efforts’ completed
A Sterigenics spokesperson declined to address specific questions about the investigations and instead provided a statement saying the company has “successfully completed remediation efforts to address the previously-announced South Coast Air Quality Management District (SCAQMD) notice of violation and has not received any subsequent citation or notice of violation from SCAQMD or OSHA.”
“We continue to cooperate with standard document requests to ensure SCAQMD and OSHA have all the information necessary to verify the continued safety of workers and the surrounding community,” the spokesperson said. “As SCAQMD has previously indicated, EtO levels in the surrounding residential community are within background levels and below health risk levels established by California Office of Environmental Health Hazard Assessment.”
Mogharabi confirmed that Sterigenics has addressed three out of four of the issues identified in the May notice of violation and has submitted a new permit application regarding the fourth. The AQMD’s investigation, including air sampling and evaluation of Sterigenics’ equipment, is still ongoing.
The state regulator is developing stricter rules for all medical sterilization facilities throughout the state.