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Thank you for your inquiry to the Department of Health
Services (DHS) Food and Drug Branch (FDB) Cannery Inspection Program regarding your
interest in producing a new acidified food. The following procedures are products that
will be evaluated to determine the need to be packed under pH control.
1.
You must first submit samples to the State’s consulting Laboratory for evaluation.
This sample testing and evaluation is a free service. Please complete the form,
"Request for pH Control" (pdf), in detail for each
product evaluated. Use one form for each separate product you wish to have evaluated.
Describe in detail your product formula and all ingredients, preparation methods and
manufacturing procedure, including the batch formulation, temperatures, etc. Do not
intermingle unit measurements for ingredients, such as weights in ounces and not in fluid
ounces. It is preferable if you can list the percentage of each ingredient in the formula
rather than the unit measurement. Send the completed form, along with two samples of each
product to:
University of California Laboratory for Research in Food Preservation
6665 Amador Plaza Road Suite 207
Dublin, CA 94568
2. You must prepare your food product according to your formula and pack the food into
two separate containers of the type you plan to use to market the product. The sample
should be prepared by the facility that will be processing the product. Be sure to mark
the samples with the product name, your name and address, and date of preparation. You
must keep a photocopy of the
"Request for pH
Control" (pdf) form on file for the FDB investigator’s inspection at a later date. If there are
any changes in your formula or preparation procedure, you must re-submit samples
and forms to the Laboratory for another evaluation.
3. The time frame to complete evaluation will take 4-6 weeks. After that, the
consulting Laboratory will send its recommendation to FDB. You will be advised of the
results and determination by a letter from FDB. During this time, please do not
call the U.C. Laboratory to find out the results of your product.
4. If your product is determined to be subject to FDB product release
supervision, you are required to take several steps to produce the product commercially:
- You must submit a Cannery License Application and
successfully meet the requirements of a new license inspection conducted by FDB.
- You must submit license fees and deposits required pursuant to the
Health and Safety Code Section 112675 (formerly section
28365).
- You must have a suitable production facility for manufacturing. A commercial
kitchen is satisfactory. The facility must be equipped with a pH meter and appropriate
buffers for standardization of the instrument. The sample submitted should be prepared at
this facility.
- You as a licensed cannery must comply with the Good Manufacturing Practices (GMP)
requirements pursuant to Title 21 Code of
Federal Regulations Part 110.
- You must develop an appropriate record system and retain all records as required
for all pH control products.
- You must develop a container coding system and apply the code to all containers
produced.
- Once your are licensed and have taken the above steps, you are required to notify FDB
before you begin manufacturing the product that requires the FDB release for shipment. To
routinely release product, an FDB investigator will arrange to inspect your facility and
audit your records, conduct pH determinations on samples pulled
from each batch produced, and release product that is below the maximum pH allowed.
- You are required to notify FDB inspector whenever you need a release of product,
whenever any spoilage is noted, or if any foodborne illness has been reported.
- No batches of products required to be produced under the Cannery Inspection
Program can be sold or donated until they have been officially released by FDB. Violations
of the law are subject to fines or imprisonment.
- Please note that the hourly inspection fees are charged for inspection and travel
time for your facility. These fees are accrued on a quarterly basis and you are billed at
the end of each quarter for costs to DHS and laboratory services which currently range
from $100 - $140 per hour.
- All fish and seafood products produced in a licensed cannery must also meet the federal Hazard Analysis and
Critical Control Point (HACCP) requirements before the products will be released by
FDB.
- All products should be produced under supervision of a person who has attended a
Better Process Control School.
- You are also responsible to register your facility and products you produced with the U.S. Food and Drug
Administration.
Upon the state contracted laboratory evaluation, if your product is not subject to the
FDB’s cannery inspection and product release, the processed food product must still
be manufactured in a food processing facility registered with FDB’s Processed Food Registration Program (PFR). Please call
(916) 650-6500 for PFR registration information and application form.
Note: Regarding sample submission to the U.C. Laboratory for evaluation,
your product formulation is protected under the law: State of
California Health and Safety Code Section 110165. It is unlawful for any person to use to his own advantage, or to reveal to any person
other than to the director or officers or employees of this department, or to
the courts when relevant in any judicial proceeding under this division, any
information acquired under authority of this division concerning any method or
process which as a trade secret is entitled to protection.
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