1. (a) Application for Official State Process Letters

   1. (1) Acidified Foods. Product and process information for acidified foods must be submitted to the Department on Form CDPH 8589 (Rev. 8/2023) Request For pH Control, hereby incorporated by reference.
   2. (2) Low-Acid Foods. Product and process information for low-acid foods must be submitted to the Department on Form CDPH 8562 (Rev. 10/2023) Request for Official Sterilization Process, hereby incorporated by reference.

2. (b) Application for Operational Documents

   1. (1) Processing system information must be submitted to the Department on Form CDPH 8562 (Rev. 10/2023) Request For Official Sterilization Process, hereby incorporated by reference.

3. (c) The completed applications provided for in paragraphs (a) and (b) must be submitted to the Department for review. These applications are available on the California Department of Public Health -- Food & Drug Branch Cannery Inspection and Licensing Program's Web site at https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/CanneryInspectionProgram.aspx.

   1. (1) If an application is incomplete, the Department shall notify the applicant. The applicant must submit the missing information to the Department, or resubmit the application forms with the missing information, no later than thirty (30) calendar days from the date of notification from the Department. The application shall be deemed abandoned if the missing information is not submitted within the specified timeframe and the applicant must reapply.
   2. (2) The Department shall evaluate each complete application on a case-by-case basis, based on an analysis of each application's unique combination of factors including: pH, time and temperature values, product formulation, ingredients, preservative levels, the processing system, and the packaging container materials, for each product in each container size. Upon completion of this evaluation, the Department shall issue Official State Process Letters and Operational Documents identifying requirements for processing system operations, scheduled processes, and critical factors requiring control under the conditions of manufacture for a given food to achieve commercial sterility.
4. (d) Any person that changes an evaluated product or processing system, for which the Department has issued Official State Process Letters or Operational Documents, must obtain new Official State Process Letters or Operational Documents from the Department. These changes include but are not limited to changes to processing systems, equipment employed, or equipment parts and components outside of routine maintenance, changes to product formulation, changes to container size or material, or any other condition related to the scheduled process. These changes shall render existing Official State Process Letters and Operational Documents invalid.

Official State Process Letters and Operational Documents must be obtained prior to manufacturing acidified foods or low-acid foods.

Note: Authority cited: Sections 100275, 110065, 112825 and 131200, Health and Safety Code. Reference: Sections 12405 and 12455, California Code of Regulations. Title 21 Code of Federal Regulations Sections 108.25 and 108.35.

History

1. New section filed 12-15-2025 as an emergency; operative 1-1-2026 (Register 2025, No. 51). A Certificate of Compliance must be transmitted to OAL by 6-30-2026 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 6-25-2026 as an emergency, including amendment of subsection (c); operative 7-1-2026 (Register 2026, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-28-2026 or emergency language will be repealed by operation of law on the following day.