Pharmaceutical operations which emit air contaminants require a permit to operate. The following information will assist in the completion and submittal of an application for each pharmaceutical operation. Each section of the page contains important information needed to process an application.
The District collects information about equipment and processes that are required to have a permit by asking for completion of application forms. These forms tell us about your operation and allow us to permit your process. It is very important that these forms are filled out completely and accurately. Errors and missing information may lead to delayed processing time and additional charges if revisions are required. Please carefully review and complete the forms. You may contact the District with any questions.
Please provide a detailed description of the process and safety data sheets for all materials used in the operation. Please provide a process flow diagram (PFD) and a site map detailing the emissions points for this operation.
Control Device (if applicable) Word PDF
The general application and toxic form with the PFD, safety data
sheets, and site map must be submitted with each application
The correct fee must be submitted with your application in order for it to be accepted. For this type of equipment, fees are determined based on the time and materials required to conduct the review, so a fee estimate must be obtained from the District prior to submittal. Please note that application fees are estimated and the final fee may be more or less than this amount based on time and materials spent processing the application. The District maintains work records for this purpose.
Before submitting an application, contact the District (see Assistance tab) to obtain an application fee estimate for application submittal. Please note that an additional fee may also apply depending on the method of payment. A breakdown of how the application fee(s) are determined can be seen here. Additional information can be found in District Rule 40.
These fees may be paid by check payable to "Air Pollution Control District" or by credit card (Visa, MasterCard, Discover, and American Express).
If you choose to email or fax your application and intend on paying with a credit card, ensure that you have obtained your fee estimate and have it in hand, and then after submitting the application, you must contact the District over the phone at (858)586-2600 to provide payment information.
Please note that credit card payments are assessed a transaction fee of 2.19% that is charged by the credit card provider.
The District will act on complete applications as soon as possible but at most within 180 days. The engineer assigned to your application will review it and contact you within 30 days of receipt to confirm that it is complete or request additional information. Typically permits are issued in about 60 days. More complex processes will take longer. Common reasons that applications may take longer than 60 days to evaluate include: the project is a complex project specifically at a major source, if the project requires a mandatory public notice period due to being installed within 1000 feet of a school or triggering the requirement for a air quality impact analysis (AQIA), if they do not initially pass a health risk assessment (HRA) or AQIA, if BACT is not proposed or complete BACT analysis is not submitted or for major sources if actual emission data is not included.
Ensuring your application is complete is the best way to reduce processing time. Complete emissions data is the most important factor in minimizing application processing time and iterative information requests. If you have any questions about what information is required, please contact the District using the information on the Assistance tab.
Sign up for Citizen Access to get up to date information on the status of your application.
Learn more about the permitting process and what to expect.
If a piece of equipment or a process emits more than 10 pounds per day of particulate matter (PM10), oxides of nitrogen (NOx), volatile organic compounds (VOC) or oxides of sulfur (SOx), the application must include a best available control technology (BACT) analysis. The District has a BACT guide to assist with the analysis. If you have questions or need assistance reference the contact information at the bottom of this page. Please review District Rules 20.1 and 20.2.
District Rule 1200 applies to any new, relocated, or modified emission unit which may increase emissions of one or more toxic air contaminant(s). The proposed project must comply with Rule 1200. Proposed equipment may require toxics best available control technology (TBACT) depending on the project. Please review District Rule 1200 for further details.
District rules address how information that is submitted to the District is managed. District Regulation IX contains District Rules 176 and 177. Please refer directly to these rules when submitting trade secret information. However, be aware that you will need to submit:
Applications submitted with incomplete material composition data due to failure to include proprietary information can significantly delay permit applications. In an effort to expedite the permit application process it is recommended that you contact the manufacturer or vendor of any proprietary materials that are used in the process and prepare the required letters as part of your application submittal.
In 1989, the California state legislature passed a law, AB 3205, designed to protect schoolchildren from hazardous air contaminants. The law, as currently written, requires the District to notify parents of schoolchildren, neighboring businesses and residents of all new or modified equipment that emits any hazardous air contaminant into the air which will be installed within 1,000 feet of a school site. The law also requires the District to consider any comments before authorizing construction. Please review your proposed location. If a school property boundary is located within 1,000 feet of the proposed emissions point, the AB3205 process will be initiated. This process requires a 30 day public comment period and the overall process will delay projects by at least six weeks.
Some pharmaceutical operations may be subject to NESHAP. The engineer assigned to your project will review the operation(s) in order to determine if any of these regulations apply.
Several District rules may apply to your equipment. The equipment
specific rule that applies to pharmaceutical operations is Rule
67.15. A complete listing of the District's rules can be found here.