Información en español
Recent Updates
On August 21, 2022, Parter voluntarily shut down its EtO operations until additional air pollution controls can be implemented including the modifications and upgrades to air pollution control equipment and enclosures. On September 22, 2022, South Coast AQMD approved a permit for the upgrades which includes installation of additional dry bed scrubbers and completion of a Permanent Total Enclosure (PTE) for all EtO operations that will capture EtO emissions, and all EtO emissions from the chambers will be directed to two layers of air pollution controls. A source test will be required to be conducted after the air pollution control equipment is constructed to assess the effectiveness of the equipment.
As of October 11, 2022, the system was still being commissioned to ensure proper operation of the new equipment.
Background
South Coast AQMD has an ongoing investigation into emissions of Ethylene Oxide from facilities within our jurisdiction. For more information on the overall initiative please visit: www.aqmd.gov/eto.
Parter Medical Products, Inc. (Parter) conducts sterilization services for medical device manufacturers using a gas called Ethylene Oxide (EtO). The Parter facility is located in Carson with operations that run 24 hours a day, seven days a week. The nearest residential area is about 700 feet from Parter and the nearest elementary school is about 2,000 feet from Parter.
Based on air sampling around the facility, elevated levels of EtO have been discovered, and South Coast AQMD is taking immediate actions to identify sources within the facility and reduce emissions as quickly as possible, including:
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Air monitoring efforts at the facility
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Issuance of a Proposition 65 Notice (PDF)
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A complete investigation into the facility’s equipment, processes, and compliance with air quality rules, regulations and permit requirements, and the issuance of a Notice of Violation (NOV) under South Coast AQMD rules and state law.
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Evaluation of immediate actions to be taken by the facility to reduce EtO emissions including closing and sealing of various openings in the building.
More Information
Ongoing Investigation
South Coast AQMD has conducted multiple on-site inspections at the facility and conducted field operations in the surrounding area. On July 29, 2022, an NOV was issued to Parter for Public Nuisance in violation of agency Rule 402 and California Health & Safety Code § 41700. This violation was based on EtO emissions detected through air monitoring efforts outside of the facility.
AB 2588 Air Toxics “Hot Spots” program
South Coast AQMD’s Rule 1402 which implements the Air Toxics "Hot Spots" program requires certain facilities with toxic emissions to prepare health risk assessments to evaluate the potential impact to the public. Parter is being evaluated as a Potentially High-Risk Level Facility. If potential health risk levels exceed thresholds set by South Coast AQMD, the facility is required to conduct public notification activities, and take actions to reduce their risk. As part of the AB 2588 program, the agency is evaluating the appropriate next steps for the facility, including accelerated requirements to reduce risks above threshold. If the facility is designated as a Potentially High-Risk Level Facility, they would be required to develop an Early Action Reduction Plan within no more than 90 days, and immediately implement the plan once approved. Additional risk reduction actions may also be required once the facility completes a detailed health risk assessment.
Air Monitoring Efforts
South Coast AQMD, with assistance from the California Air Resources Board (CARB), is conducting local air monitoring to determine levels of EtO near the facility and in the surrounding community. Mobile monitoring was conducted to collect survey data on volatile organic compounds (VOCs), and signals associated with EtO were elevated near and downwind of the facility. Individual grab samples (an air sample collected at one location at one point in time) were taken to confirm elevated ethylene oxide levels. 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. The agency will continue to work with Parter to identify the source(s) of EtO from their operations and identify actions to reduce emissions. Based on the monitoring data, measurements have been consistent at background levels since the beginning of air monitoring efforts in July 2022. South Coast AQMD is planning to remove the one air monitor at Site #3 during the week of February 28, 2023. Monitors will remain at Sites #1 near the facility, Site #2, and Site #4 as shown in the map below.
24-Hour Integrated Sample Locations
Note: This plot is interactive, individual data points can be viewed with a mouse hover. The view can be reset by selecting the circular arrows to the right of the plot.
24-hour Time-integrated Sample data (concentrations in ppbv)
** On 7/28/22, Site #1 sample begin time was 12:15
On 10/2/22, Commissioning of air pollution control equipment commenced
On 10/14/2022, Site #4 sampling began at 00:01
On 11/1/2022, Site #2 temporarily relocated due to roadwork
Health Impacts
South Coast AQMD is required to use methodologies developed by the Office of Environmental Health Hazard Assessment (OEHHA) in its health risk programs. Air monitoring efforts for a more extensive evaluation are continuing in the community. Health impacts will be assessed when more data about the level of exposure to the community is available.
A Propostion 65 Notice (PDF) was issued on July 28 notifying the City of Carson, Los Angeles County Board of Supervisors and the Los Angeles County Health Officer of the illegal discharge likely to impact public health or safety.
South Coast AQMD has also notified the California Division of Occupational Safety and Health Administration
(Cal/OSHA) of potential exposure to employees at the Parter facility. Additionally, South Coast AQMD is working closely with the Los Angeles County Department of Public Health and is providing data to public health officials for additional risk assessment.
Permitting
The Parter facility is permitted for multiple EtO sterilization chambers, aeration rooms and associated air pollution control equipment. Products are loaded into sealed sterilization chambers where EtO is injected. Chambers are required to have strict requirements to capture the EtO gas and prevent 99.9% of emissions. The facility has submitted permit applications for a variety of items including a new dry bed scrubbers and administrative changes.
On September 22, 2022 South Coast AQMD approved a permit for additional dry bed scrubbers. The permits require control equipment for the dry bed scrubbers that will control at least 95% of EtO emissions from operations and the installation of a PTE that will allow the facility to maintain negative air pressure and prevent fugitive air and contaminants from escaping the building. The additional layer of controls will result in higher control efficiencies, which will be verified through Source Tests.
Once the equipment is installed and operational, tests will be performed to verify that negative pressure has been achieved in the PTE and it will be required by the permit to be monitored and maintained. Source Tests for the dry bed scrubbers are expected to take place within 180 days of issuance of the Permit to Construct to ensure proper control efficiency (recurring annually).
The facility’s permits can be accessed through South Coast AQMD’s Facility Information Detail (F.I.N.D.) system using the facility address or ID number (77129).
Rulemaking
EtO sterilization and aeration facilities are subject to local, state, and federal regulations. South Coast AQMD Rule 1405 (PDF) - Control of Ethylene Oxide and Chlorofluorocarbon Emissions from Sterilization or Fumigation Processes reduces emissions of EtO from sterilization operations.
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. We are working on amending Rule 1405 to strengthen requirements to address fugitive emissions, as well as provisions to further reduce EtO emissions from operations at these facilities. The rulemaking process, including Working Group meetings are ongoing and open to the public. Upcoming meeting dates can be found at the Proposed Amended Rule 1405 page.
This plot is interactive, individual data points can be viewed with a mouse hover. The view can be reset by selecting the circular arrows to the right of the plot.
(insert Bokeh file here)
This plot is interactive, individual data points can be viewed with a mouse hover. The view can be reset by selecting the circular arrows to the right of the plot.
(insert Bokeh file here)