What is the significance of Foodborne Botulism?

Foodborne botulism is a rare but potentially fatal illness caused by the ingestion of food containing toxin produced by the bacterium, Clostridium botulinum. Although C. botulinum itself is harmless and commonly found within the environment and certain foods we eat, under anaerobic (absence of oxygen) conditions and warm temperatures, C. botulinum spores can produce botulinum toxin. Botulism is characterized by the following symptoms: Symmetric, descending, flaccid paralysis of motor and autonomic nerves, muscle weakness, blurred vision, dysphagia (difficulty swallowing), dry mouth and dysarthria (speech impairment). The symptoms of botulism will usually manifest themselves within 12 to 72 hours after consumption of food containing the toxin. If left untreated, paralysis and respiratory failure may occur, resulting in death or permanent injury. 

What is the significance of the Cannery Inspection and Licensing Program?

Scientists classify canned/processed foods based on particular characteristics which can affect their safety. Hermetically sealed containers of low-acid food that are devoid of oxygen and stored without refrigeration are particularly susceptible to the growth of C. botulinum and the hazard of botulinum toxin if not properly processed. To help prevent the spread of foodborne botulism, low-acid and acidified foods are regulated under the Food and Drug Branch (FDB) Cannery Inspection Program. Food processors (Canneries) manufacturing these types of foods must comply with California and federal requirements and operate under a valid Cannery License that is renewed every year. Products made under the Cannery License must be processed under compliance with Official State Process Letters (sometimes referred to as an “S-Letter”) in order to achieve commercial sterility, which means the elimination of pathogenic and spoilage microorganisms, and reviewed by a State Cannery Inspector prior to releasing product for shipment. 

Canneries engaged in general food processing activities, or in the manufacturing, packing, or holding (storing/warehousing) of foods that do not fall under acidified or low-acid foods, must operate under a valid Processed Food Registration (PFR). Canneries that manufacture acidified and/or low-acid foods, and maintain a valid PFR License, are not required to pay for Cannery Application/Renewal fees; however, canneries must pay all costs associated with cannery inspections.

What is considered an acidified food?

Acidified foods are shelf-stable (non-refrigerated) foods packed in hermetically sealed containers that contain a low-acid food ingredient(s) to which acid(s) or acid food(s) is added to produce a finished product with an equilibrium pH of 4.6 or below, and a water activity (aw) greater than 0.85. These types of Acidified foods include, but are not limited to sauces, salsas, pickled vegetables and peppers, marinades, and certain beverages. 

In order to determine if a food is acidified or not, products must be evaluated by the University of California Laboratory for Research in Food Preservation (UCLRFP), using a Request for pH Control form. The product formulation, preparation procedures, processing procedures and a product sample shall be provided to the UCLRFP in detail to facilitate the evaluation. Upon evaluation, FDB will issue an Official State Process Letter for each product submitted to the UCLRFP, indicating whether the product is an acidified food that must be packed under a valid Cannery License. If the product is an acidified food, the S-Letter will include the ‘critical parameters’ necessary to achieve commercial sterility, which shall be reviewed by FDB prior to being released for shipment. A product sample selected by FDB, upon review, shall also be sent to the UCLRFP for pH verification. 

What is considered a low-acid food?

Low-acid foods are shelf-stable (non-refrigerated) foods, other than alcoholic beverages, packed in hermetically sealed containers with a finished equilibrium pH greater than 4.6 and water activity (aw) greater than 0.85. Shelf-stable low-acid foods must achieve commercial sterility by means of thermal processing to eliminate public health hazards, such as the presence of Clostridium botulinum spores, and other foodborne pathogens and spoilage organisms.

Low-acid food products must be submitted to the UCLRFP, using a Request for Official Sterilization Process form, for review and evaluation. The product formulation, container size, and processing procedures shall be provided to the UCLRFP in detail to facilitate the evaluation. Upon evaluation, FDB will issue an Official State Process Letter for each product submitted to the UCLRFP, indicating the ‘critical parameters’ necessary to achieve commercial sterility, which shall be reviewed by FDB prior to being released for shipment. 

Additional Information and Questions

Learn how to obtain a cannery license or see the helpful links below.

Still have additional questions?  Please view our Frequently Asked Questions (FAQ) for inquiries made to FDB from canneries.