For the purposes of this Article, the following definitions shall apply:

“Acidified foods” means shelf-stable low-acid foods to which acid(s) or acid food(s) are added and packaged within hermetically sealed containers with a finished equilibrium pH of 4.6 or below and a water activity (a_w) greater than 0.85.

“Commercial sterility” of food means the condition achieved by the application of heat, the control of water activity (a_w), the control of pH, or other treatment which renders the food free of microorganisms capable of reproducing in the food under nonrefrigerated conditions of storage and distribution, and viable microorganisms (including spores) of public health significance.

“Critical factor” means any property, characteristic, condition, aspect, or other parameter, the variation of which may affect the scheduled process and the attainment of commercial sterility.

“Hermetically sealed container” means a container that is designed and intended to prevent the entry of microorganisms and thereby to maintain the commercial sterility of its contents after processing.

“Low-Acid foods” means any shelf-stable foods, other than alcoholic beverages, packaged in hermetically sealed containers with a finished equilibrium pH greater than 4.6 and a water activity (a_w) greater than 0.85 (historically referred to as “low-acid canned foods” or “LACF”). Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not low-acid foods.

“Official State Process Letters” means documents identifying critical factors and the scheduled process issued by the Department under the conditions of manufacture for a given food to achieve commercial sterility.

“Operational Documents” means documents identifying critical factors and the specifications issued by the Department under the conditions of manufacture for a given processing system to administer the scheduled process required of a given food to achieve commercial sterility.

“Process deviation” means the event in which any process or critical factor fails to satisfy the minimum requirements of the scheduled process identified in Official State Process Letters or Operational Documents for any acidified food, low-acid food, or processing system as disclosed from records by processor check or otherwise.

“Processing system” means retorts, aseptic processing and packaging systems, or any other equipment used to administer the scheduled process required of a given acidified food or low-acid food to achieve commercial sterility.

“Scheduled process” means the process selected by the processor under the conditions of manufacture for a given food to achieve commercial sterility. This process shall be at least equivalent to the process identified in Official State Process Letters and Operational Documents.

Note: Authority cited: Sections 100275, 110065, 112825 and 131200, Health and Safety Code. Reference: Sections 12405 and 12455, California Code of Regulations; and Title 21, Code of Federal Regulations, Sections 113.3 and 114.3.

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; 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.