Proposed Amended Rule 1405 – Control of Ethylene Oxide Emissions from Sterilization and Related Operations


SCH Number
Public Agency
South Coast Air Quality Management District
Document Title
Proposed Amended Rule 1405 – Control of Ethylene Oxide Emissions from Sterilization and Related Operations
Document Type
NOE - Notice of Exemption
Document Description
Proposed Amended Rule (PAR) 1405 seeks to further reduce stack and fugitive emissions of ethylene oxide (EtO) and gather information from: 1) facilities that conduct sterilization and related operations; 2) facilities that receive materials that have been sterilized with EtO in another facility; and 3) warehouses receiving materials sterilized with EtO. PAR 1405 contains: 1) enhanced performance standards for stack emissions; 2) new emission limits based on achievedin-practice levels observed at EtO sterilization facilities; 3) improved control efficiency requirements to further reduce stack emissions; 4) provisions to prevent, detect, and capture any potential EtO emissions; 5) new requirements which rely on permanent total enclosures (PTEs) for equipment and areas with known EtO emissions to prevent fugitive emissions from leaving facilities by containing and controlling any EtO gases inside the PTE; and 6) enhanced leak detection and repair. PAR 1405 also includes: 1) a new definition for large facilities subject to the most stringent requirements that reduces the throughput from 4,000 to 2,000 pounds per year of EtO; 2) interim fenceline air monitoring requirements for Tier I warehouses for one year and large facilities until certified Continuous Emission Monitoring Systems or Semi-Continuous Monitoring Systems are in place; 3) requirements to monitor stack and fugitive emissions; 4) interim mobile monitoring requirements for large sterilization facilities; 5) requirements for certain large warehouses to provide records and emissions data; 6) curtailment provisions to reduce EtO fenceline levels when trigger thresholds are exceeded as determined by fenceline air monitoring; 7) requirements to conduct continuous monitoring of key parameters and reporting; 8) requirements to label equipment and provide facility diagrams for all types of sterilization facilities and Post-Aeration Storage facilities; 9) new and modified definitions, recordkeeping and source testing requirements, and prohibitions; and 10) other clarifications for continuity and consistency throughout the rule. The benefits of reducing stack and fugitive emissions of EtO from sterilization and related operations will reduce the risk of EtO exposure to nearby receptors through enforceable rule terms and permit conditions.

Contact Information

Farzaneh Khalaj
Agency Name
South Coast AQMD
Job Title
Air Quality Specialist
Contact Types
Lead/Public Agency


Los Angeles, Orange, Riverside, San Bernardino
Other Location Info
The proposed project is located within the South Coast Air Quality Management District’s (South Coast AQMD) jurisdiction, which includes the four-county South Coast Air Basin (all of Orange County and the non-desert portions of Los Angeles, Riverside, and San Bernardino counties), and the Riverside County portion of the Salton Sea Air Basin and the non-Palo Verde, Riverside County portion of the Mojave Desert Air Basin.

Notice of Exemption

Exempt Status
Type, Section or Code
Reasons for Exemption
South Coast AQMD, as Lead Agency, has reviewed the proposed project (PAR 1405) pursuant to: 1) CEQA Guidelines Section 15002(k) – General Concepts, the three-step process for deciding which document to prepare for a project subject to CEQA; and 2) CEQA Guidelines Section 15061 – Review for Exemption, procedures for determining if a project is exempt from CEQA. Of the various provisions included in PAR 1405 aimed at further reducing stack and fugitive EtO emissions from sterilization operations, the potential installation of monitoring equipment and PTEs at a few facilities are the only activities which would involve physical modifications, if any, which may be achieved via minimal construction equipment. Thus, it can be seen with certainty that implementing the proposed project would not cause a significant adverse effect on the environment, and is therefore, exempt from CEQA pursuant to CEQA Guidelines Section 15061(b)(3) – Common Sense Exemption.
County Clerks
Los Angeles, Orange, Riverside, San Bernardino


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