Acidified Foods (AF) and Low-Acid Canned Foods (LACF) that may support the growth of Clostridium botulinum must be packed under a valid Cannery License issued by the California Department of Public Health, Food and Drug Branch (FDB). After the pre-licensing inspection and issuance of a Cannery License, periodic inspections are required to ensure continued compliance with all applicable laws and regulations.

• California Health and Safety Code (H&SC) Section 112650 et. seq.
• Title 17, California Code of Regulations, Section 12400 et. seq.
• Title 21, Code of Federal Regulations (CFR) Part 101
• Title 21, CFR Part 110 – Current Good Manufacturing Practices
• Title 21, CFR Part 108 – for LACF and AF products
• Title 21, CFR Part 113 – for LACF products
• Title 21, CFR Part 114 – for Acidified Foods
  
• If the acidified food or LACF contains fish or fishery products, the canner will be required to meet the federal Hazard Analysis Critical Control Point (HACCP) regulations specified in Title 21, CFR Part 123. 

Additionally, the Cannery Inspection Program is a fee-for-service program that requires batch releases of all Acidified Food and/or LACF products prior to distribution. 

Batch Releases

Once licensed, the canner can legally initiate canning operations. Canners are required to notify FDB before beginning initial production of Acidified and/or LACF food products. No Acidified or LACF product can be distributed or donated until the batch has been officially released by FDB personnel. This activity is referred to as a “cannery release."

Cannery releases must be scheduled in advance with FDB personnel. Cannery releases can be conducted on an established schedule (e.g., every Tuesday and Thursday), or on an “as-needed" basis. To ensure availability of FDB personnel, please notify FDB at least 2 business days prior to the day that the cannery release is needed.

During the cannery release, FDB personnel will review the scheduled process letter (S-Letter) and records associated with the products being released, to ensure compliance with the critical factors identified on the S letter(s). FDB personnel will check the pH of acidified foods and complete the “Inspector's pH" portion of the production record. Canner and FDB pH readings must be conducted with a properly calibrated pH meter provided by the canner. The cannery release may also include an inspection of the facility to evaluate sanitation, container integrity, or other aspects of the cannery operation​

If no deviations are identified, FDB personnel will stamp the production record and officially release the batch for distribution. For acidified foods, the canner will be responsible to send a sample of each released product to the University of California Laboratory for Research in Food Preservation (UCLRFP) for confirmation pH testing.

If FDB personnel identify deviations from the scheduled process, the canner will be issued a Quarantine/Restraining Order (QRO). Quarantined products cannot be removed from the facility until authorized by FDB. FDB personnel will forward a copy of the QRO to the UCLRFP, who will evaluate the process deviation and issue a recommendation to FDB regarding disposition of the product. UCLRFP staff may contact the canner to request additional information or documentation to aid in the evaluation. FDB personnel will notify the canner of the disposition action to be taken and may oversee some operations such as Voluntary Condemnation & Destruction and/or overhaul. Canners should not contact UCLRFP directly to inquire about QRO dispositions, such inquiries are to be directed to FDB personnel. 

Pursuant to California law, cannery release activities are a “fee-for-service". Hourly fees are assessed for inspection and travel time associated with cannery release activities. Pursuant to Health and Safety Code Section 112765, canners are required to maintain a deposit on file with FDB. The FDB Cannery Desk issues monthly invoices describing the amount due and payable for services provided. 

Notify FDB immediately if:

• Spoilage is noted in acidified and/or LACF products.
  
• Foodborne illness has been reported to the canner in association with acidified and/or LACF products.
• Significant worker injuries occur at the cannery. Significant injuries include: blood loss, amputation of a body part, crushing injuries, or death.
  
• Any Acidified and/or LACF product is distributed without FDB release.

Retort Operator Examination

California law requires all operators of thermal processing equipment (e.g., retorts and aseptic processing systems) to be permitted. Operators will receive a Retort Operator Permit after successfully passing a written and practical examination administered by FDB personnel. Each canner must provide FDB with a list of candidates for the examination. The examination is conducted by appointment and will not be scheduled until the canner has obtained a valid Cannery License, Official Scheduled Process (S-letters) have been issued, and the thermal processing equipment is fully operational. The Retort Operator Permit is issued to the individual operator and is valid for the specific equipment that the operator was tested on. Retort Operator Permits are not transferrable. 

Food and Drug Branch

1-800-495-3232

FDBfood@cdph.ca.gov