*Disclaimer: If you manufacture and/or sell/market any other product(s) that contain cannabis as an ingredient, our lab cannot assist you even if that new product does not contain cannabis.*
Food products packaged in hermetically sealed (air tight) containers are subject to regulations equivalent to the Code of Federal Regulations, Title 21, Parts 108, 113, and/or 114 (21 CFR 108, 113, and/or 114). Of course, all food products also must comply with a number of other regulations including labeling, net contents, good manufacturing practices, etc.
Low acid foods have finished equilibrium pH greater than 4.6. Acid foods have a natural finished equilibrium pH of 4.6 or less. Acidified foods also have a finished equilibrium pH 4.6 or less but have a significant low acid component. Acidified foods include pickled vegetables, most salsas, and many other formulated products. Exceptions to the acidified foods regulations include carbonated beverages, alcoholic beverages, refrigerated and frozen products, and products with water activity 0.85 or less. Jams and jellies which meet the published standards of identity are exempt since their water activities are 0.85 or less.
A process authority (a person with expert knowledge in processing) determines the product classification and the processes for low acid and acidified foods. The rest of this document will address only acidified foods.
Copies of 21 CFR 108, 110, and 114 are attached for your information. It is our understanding that processors who are under the jurisdiction of the Washington State Department of Agriculture and the State Department of Health/local health departments are subject to these same regulations with a few modifications. There is substantial mandatory record keeping required for acidified foods, including (but not limited to) the following:
All mandatory records must be retained at a reasonably accessible location for at least 3 years from the date of manufacture.
In addition, every processing facility which processes low acid and/or acidified food products must be registered with the FDA (FDA Form 2541). The official process for each product x container combination must also be filed (FDA Form 2541a).
The regulations also include an education requirement. “All operators of processing and packaging systems for acidified food shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction in food handling techniques, food protection principles, personal hygiene and plant sanitation, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction (21 CFR 114.10).” WSU is an approved school and offers courses several times each year for as few as 6 students per time.
According to 21 CFR 114.80(a)(1) all acidified foods “. . . shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of non-health significance capable of reproducing in the food under the conditions in which food is stored, distributed, retailed, and held by the user.”
Official processes for acidified foods include maximum pH as well as thermal processes. The thermal processes are often described as “hot fill/hold” or “hot water bath/steam bath” methods. Following are descriptions of each.
We strongly recommend that producers of acidified food products purchase and properly use a digital pH meter and appropriate accurate calibrated thermometers. Producers of jams, jellies, preserves, fruit butters, spreads, syrups, and other similar products are strongly advised to purchase and utilize appropriate refractometers. Many consider these instruments to be expensive, but we believe they are necessary for reasonable operation of a profitable food business.
For further information and assistance with any of the above please contact:
Dr. Girish Ganjyal, Extension Food Processing Specialist
Washington State University
1945 Ferdinand’s Lane
106 FSHN Bldg
P.O. Box 646376
Pullman, WA 99164-6376
Phone: 509-335-5613
FAX: 509-335-4815
Email
**Disclaimer: If you manufacture and/or sell/market any other product(s) that contain cannabis as an ingredient, our lab cannot assist you even if that new product does not contain cannabis.**
For safety evaluation of your acidified product, please follow the directions below:
Product evaluation for potential safety issues, process classification, potential quality problems which might be associated with the product, etc.
Timeline: Dr. Ganjyal will contact your within 5 weeks to discuss your results, after which a process authority letter will be mailed out to you. If you do not have the correct information, like filling out the recipe spreadsheet completely, it will delay the process.
For these types of products (using hot fill hold process) we ask that 2 jars of product, packed in the jar size that will be sold be sent into our lab:
For example, if you want to test a blueberry jam, strawberry jam, and blackberry jam, they are three different products thus we ask you send a $450 or $600.
Another example, if you have a strawberry jam and you want to test pint glass jar, quart glass jar, and half gallon glass jar. Those are considered three different recipes due to the processing, and we would ask you send a $450 or $600.
Process determination with specified pH, process times/temperatures, and critical factors.
For these types of products we ask that 6 jars of product, packed in the jar size that will be sold be sent into our lab. These must have acid ingredient like citric acid, vinegar, lime juice, and etc.:
Example, if you have a salsa and you want to test the mild salsa, medium salsa, and extremely spicy salsa. Those are considered three different recipes and we would ask you send a $750 or $825.
Another example, if you have a salsa and you want to test pint glass jar, quart glass jar, and half gallon glass jar. Those are considered three different recipes, due to the processing, and we would ask you send a $750 or $850.
For basic microbiological testing, please visit Washington Animal Disease Diagnostic Laboratory’s website.
For non-traditional microbiological testing, please email Dr. Stephanie Smith.
