BOARD MEETING DATE: February 12, 1999 AGENDA NO. 2
PROPOSAL:
Set a Public Hearing March 12, 1999 to Amend Rule 1103 – Pharmaceuticals and Cosmetics Manufacturing Operations
SYNOPSIS:
The proposed amendments to Rule 1103 – Pharmaceuticals and Cosmetics Manufacturing Operations will address the issues cited by EPA and CARB. In addition, staff is proposing several modifications to clarify rule language. In December 1997, EPA indicated that the State Implementation Plan could not be approved until this and other AQMD rules were modified. The deadline for completing this task is June 1999.
COMMITTEE:
Stationary Source Committee Meeting, January 22, 1999, Reviewed
RECOMMENDED ACTION:
Set a Public Hearing March 12, 1999 to amend Rule 1103 - Pharmaceuticals and Cosmetics Manufacturing Operations.
Barry R. Wallerstein, D.Env.
Executive Officer
Background
Rule 1103 was originally adopted on April 6, 1980. On May 13, 1991 Rule 1103 was submitted by the California Air Resources Board (CARB) to the Environmental Protection Agency (EPA) in response to EPA’s 1988 State Implementation Plan (SIP) Call. On September 23, 1992 and May 14, 1997 EPA issued a Federal Register proposal to finalize the limited approval and limited disapproval of Rule 1103 in the California SIP. On December 9, 1997 EPA notified the AQMD that on November 13, 1997 the final rule that included Rule 1103 was published in the Federal Register. EPA’s evaluation of Rule 1103 for consistency with the requirements of the Clean Air Act (CAA) concluded that finalizing the limited disapproval of Rule 1103 would require the correction of certain issues in the rule. EPA's deadline for making these SIP corrections was 18 months after the December 1997 notification or by June 1999.
On January 29, 1998, CARB held a public meeting to consider the approval of the AQMD’s 1997 Air Quality Management Plan (AQMP) under the California Clean Air Act (CCAA). As a result of this public meeting, CARB conditionally approved the 1997 AQMP with the condition that the AQMD add specific improvements to Rule 1103.
Proposal
Proposed amendments to satisfy the concerns of EPA and CARB are set forth below. In general, these amendments will provide clarification of requirements already imposed by existing rule language, permitting, and emissions testing procedures.
In addition to satisfying the issues cited by EPA and CARB, staff is also proposing administrative changes such as adding definitions for "Capture" and "Control Device Efficiency" to clarify rule language regarding test methods. A new definition for "Key System Operating Parameter", a definition for "Production Equipment" and a definition and maintenance requirement for liquid leaks are also proposed. These amendments provide language consistency with other AQMD rules and provide clarifying language for enforcement purposes.
The amendments to Rule 1103 to correct the concerns of EPA and CARB should not cause any measurable increase in emissions from the subject equipment or put any additional economic burden on any affected facility.
AQMD & Legal Mandates
By statute, AQMD is required to adopt an Air Quality Management Plan (AQMP) demonstrating compliance with all state and federal ambient air quality standards [Health and Safety Code Section 40460(a)] for the Basin and non-Basin areas under the jurisdiction of the SCAQMD, referred to here as the "AQMD". The AQMD must adopt rules and regulations that carry out the AQMP [California Health and Safety Code, Section 40440(a)]. This proposal meets those requirements by amending an existing adopted rule that can further reduce VOC emissions through advanced control technology. This proposal also meets these requirements without undue administrative burden on industry, the AQMD or other agencies.
CEQA & Socioeconomic Analysis
AQMD staff has reviewed the proposed amendment to Rule 1103 - Pharmaceuticals and Cosmetics Manufacturing Operations pursuant to the California Environmental Quality Act (CEQA) Guidelines Section 15002(k)(1) – Three Step Process, and determined the amendments are exempt from the requirements of CEQA. The proposed amendments do not make substantial changes or create potential impacts to the previous final Environmental Impact Report (EIR). Therefore, no subsequent document is required to account for the proposed amendments.
A brief socioeconomic impact assessment will be prepared for the hearing package. This assessment will indicate that the approach proposed in the rule is not expected to result in any significant financial impact on facilities.
Implementation Plan
To obtain local input on Proposed Amended Rule 1103, AQMD held a public workshop on December 18, 1998. A public notice was mailed to approximately 80 affected facilities. The AQMD staff report and proposed rule language was available at the public workshop and on the AQMD’s Internet home page. Participants had two weeks to submit comments after the public workshop.
AQMD permitting staff is responsible for implementation of Rule 1103, while AQMD enforcement staff will be responsible for field compliance with permit requirements.
Resource Impact
Existing AQMD resources will be sufficient for implementation of the changes to Rule 1103 with no impact on the budget.
Summary of Proposed Amendment (Attachment A)
Rule Development Flow Chart (Attachment B)
Proposed Amended Rule 1103
Draft Staff Report
ATTACHMENT A
SUMMARY OF PROPOSED AMENDMENTS
Rule 1103 |
| The following amendments are proposed: |
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ATTACHMENT B
RULE DEVELOPMENT PROCESS
RULE 1103 – Pharmaceuticals and Cosmetics Manufacturing Operations
Public Workshop: December 18, 1998 80 notices mailed |
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Set Public Hearing: February 12, 1999 Public Hearing: March 12, 1999 |
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