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PROPOSAL:

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 this and other AQMD rules needed modification before they could be accepted into the State Implementation Plan (SIP). The deadline for completing this task is June 1999.

COMMITTEE:

Stationary Source, January 22, 1999, Reviewed

RECOMMENDED ACTION:

Approve the attached resolution:

1. Certifying the CEQA Notice of Exemption (NOE) for the proposed amendments.
2. Amending 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.

• Equivalent control devices will meet specific control efficiency requirements instead of being approved at the discretion of the Executive Officer (EO).
• EO discretion for alternate control methods for VOC storage tanks has been removed.
• Clarification of recordkeeping requirements is proposed to ensure that key parameters of control equipment are recorded.
• A definition of "Total VOC Vapor Pressure" is added to provide a reference for determining compliance with the existing rule.
• VOC control devices are required to meet specific collection efficiency and control efficiency requirements. This is a clarification of existing rule language that requires emissions of VOC to be reduced by at least 90 percent by weight.
• Clarification that sterilizers regulated by AQMD Rule 1405 - Control of Ethylene Oxide and Chlorofluorocarbon Emissions from Sterilization or Fumigation Processes are exempt from Rule 1103 requirements. Sterilizers not regulated by Rule 1405 shall be considered production equipment and will be subject to the existing control requirements of Subparagraph (d)(1) of Rule 1103.

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)]. The 1997 AQMP does not identify Rule 1103 as a short-term control measure. This proposal, although not seeking reductions, improves rule enforceability that further ensures anticipated emission reductions from the existing rule are achieved. This proposal also meets these concerns 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. Staff has determined with certainty that these clarifications do not have the potential to significantly affect the environment.

A brief socioeconomic impact assessment has been prepared for the hearing package. This assessment indicates that the clarifications proposed in the rule are 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.

Attachments

Summary of Proposed Amendment (Attachment A)
Rule Development Flow Chart (Attachment B)
Resolution (Attachment C)
Notice of Exemption from the California Environmental Quality Act
Proposed Amended Rule 1103
Final Staff Report

ATTACHMENT A

SUMMARY OF PROPOSED AMENDMENTS

Rule 1103

The following amendments are proposed:

• Replace Executive Officer (EO) discretion for approval of equivalent control devices with specific control efficiency requirements that reflect current rule language;
• Delete the EO discretionary approval of alternative emission control systems on storage tanks that require the installation of pressure/vacuum vents to reduce VOC emissions;
• Clarify the current recordkeeping requirements by providing a more detailed list of requirements;
• Add a definition of "Total VOC vapor pressure" to provide guidance for determining compliance with existing rule requirements;
• Replace "carbon absorber, or equivalent control method approved by the executive officer" with the term "control device" which shall meet the VOC control efficiency specified in the rule;
• Clarify that sterilizers exempt from Rule 1405 are subject to Rule 1103's production equipment requirements and include an exemption in Rule 1103 for sterilizers subject to Rule 1405; and,
• Add several new definitions to clarify rule language.

ATTACHMENT B

RULE DEVELOPMENT PROCESS

RULE 1103 – Pharmaceuticals and Cosmetics Manufacturing Operations

Public Workshop: December 18, 1998 80 notices mailed
		Set Public Hearing: February 12, 1999 Public Hearing: March 12, 1999

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