BAY AREA AIR QUALITY MANAGEMENT DISTRICT
939 ELLIS STREET
SAN FRANCISCO, CA 94109
BOARD OF DIRECTORS MEETING
DATE: May 17, 2000 AGENDA NO: 12
 
PROPOSAL: Adopt proposed amendments to Regulation 11, Rule 9: Ethylene Oxide Sterilizers and approve filing of a CEQA Notice of Exemption.
SUMMARY: Public Hearing to adopt proposed amendments to Regulation 11, Rule 9. The proposed amendments to Regulation 11, Rule 9 would delete the language of Regulation 11, Rule 9 in its entirety, and adopt, by reference, the California Air Resources Board Airborne Toxics Control Measure (ATCM) for Emissions of Ethylene Oxide Sterilizers and Abators. The proposed amendments incorporate changes in the state and federal standards for ethylene oxide sterilizers since the last update to Regulation 11, Rule 9 in May, 1992.
 
RECOMMENDED ACTION:

Delete current language of Regulation 11, Rule 9 in its entirety, and adopt, by reference, the California Air Resources Board Airborne Toxics Control Measure (ATCM) for Emissions of Ethylene Oxide Sterilizers and Abators; approve filing of a CEQA Notice of Exemption
  Ellen Garvey
Executive Officer


Background
The proposed amendment to Regulation 11, Rule 9 was developed to merge federal, state and local emissions, monitoring and recordkeeping requirements for facilities with ethylene oxide sterilizers using more than 25 pounds per year of ethylene oxide. The California Air Resources Board amended their Airborne Toxics Control Measure (ATCM) for Ethylene Oxide Sterilizers and Abators on May 21, 1998 to consolidate federal and state monitoring and recordkeeping requirements so as to apply to the US EPA for a determination of equivalency with the National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilizers and Fumigation Operations. The deletion of the District rule, adoption of the ATCM and the expected equivalency determination will subject facilities with ethylene oxide sterilizers and abators to one set of standards for emissions, monitoring and recordkeeping requirements rather than separate requirements for each jurisdiction. A public workshop was conducted on March 21, 2000.
Proposal
Regulation 11, Rule 9 was originally adopted in 1989 to reduce the potential for toxic risk exposure to ethylene oxide from all ethylene oxide sterilizers in the District. It exempted all facilities with emissions of less than 25 pounds per year from emission abatement requirements, and required ethylene oxide abatement ranging from 99% to 99.9% total abatement for all facilities using 25 pounds per year or more of ethylene oxide. The District’s rule applies to both commercial and noncommercial (hospital and medical facility) sterilizers.

The proposed amendment would not change the airborne emission limitations on ethylene oxide in any way. Hospital sterilizers with a total chamber size of 10 cubic feet or less would be required to meet ethylene oxide abatement of 99% by volume; those with chamber size of more than 10 cubic feet would be required to meet ethylene oxide abatement of 99.9% by volume. In addition, facilities using non-precursor organic compounds (NPOCs) as diluent gases would be required to abate those materials by at least 95% by volume. These are identical to the provisions in the current Regulation 11, Rule 9.

Major requirements of the recently amended ATCM include:

  • Specific Reporting and Recordkeeping requirements for all facilities;
  • Specific Ethylene Oxide Emissions Control and Compliance Requirements for facilities using 25 pounds or more of ethylene oxide (same as current District emissions limitations);
  • Limitations on ethylene oxide in liquid discharges from sterilizers and aerators;
  • Compliance testing protocols for monitoring parameters for acid-water scrubbers, and catalytic and thermal oxidation abatement devices (for facilities using more than 2,000 pounds per year of sterilant gas);
  • Monitoring requirements for all sterilizers and aerators using more than 2,000 pounds per
    year of sterilant gas.
Cost and Environmental Impacts

The California Health and Safety Code requires analysis of various impacts when regulatory amendments will set more stringent requirements or impose costs on regulated entities. The proposed amendments to Regulation 11, Rule 9 are existing nationwide standards, consequently they do not impose new costs and are therefore not subject to requirements in the Health and Safety Code for socioeconomic analysis (Section 40728.5), incremental cost analysis (Section 40920.6), or regulatory overlap analysis (Section 40727.2). The proposed adoption of the state ATCM by reference does not affect the emissions standards existing in current District Regulation 11, Rule 9, as they are identical to the District’s current emissions limitations.

These proposed amendments are administrative in nature because the federal standards must be complied with regardless of District adoption. Therefore, it can be seen with certainty that the proposed amendments have no environmental impacts. The amendments are therefore exempt from the requirements of the California Environmental Quality Act (CEQA) pursuant to CEQA Guidelines Section 15061, subd. (b)(3).
California Environmental Quality Act (CEQA)

The District has determined that these amendments to Regulation 11, Rule 9 are exempt from the provision of the California Environmental Quality Act (Public Resources Code 21000 et seq.) pursuant to State CEQA Guidelines, Section 15061, subd. (b)(3). The amendments are administrative in nature, and do not in themselves affect air emissions from any sources or operations subject to the rule. It can therefore be seen with certainty that there is no possibility that these proposed amendments will have a significant environmental impact. The District intends to file a Notice of Exemption pursuant to State CEQA Guidelines, Section 15062.



Attachment A - Proposed New Regulation 11, Rule 9
Attachment B - Current Regulation 11, Rule 9 Proposed for Deletion
Attachment C - Staff Report
Attachment D - Air Toxics Control Measure    (from Air Resources Board Website)